SLGL 20-F
Sol-Gel Technologies Ltd. (SLGL)
20-F
2025-04-29
For: 2024-12-31
View Original
Added on
April 08, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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OR
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended
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OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______________ to __________________
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OR
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of event requiring this shell company report ________________
Commission file number: 001-38367
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(Exact name of Registrant as specified in its charter)
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N/A
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(Translation of Registrant’s name into English)
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(Jurisdiction of incorporation or organization)
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(Address of principal executive offices)
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Vice President & General Counsel
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Tel:
Email:
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(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
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Securities registered or to be registered pursuant to Section 12(b) of the Act.
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Securities registered or to be registered pursuant to Section 12(g) of the Act:
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None
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(Title of Class)
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Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
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None
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(Title of Class)
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Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report:
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Title of Class
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Number of Shares Outstanding
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Ordinary Shares, par value NIS 0.1 per share
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Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☐ No ☒
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act 1934.
Yes ☐ No ☒
Note – Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer”, “accelerated filer” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
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Large Accelerated filer ☐
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Accelerated filer ☐
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Emerging growth company
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If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive- based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
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International Financing Reporting Standards as issued by the
International Accounting Standards Board ☐
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Other ☐
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If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
Item 17 ☐ Item 18 ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
TABLE OF CONTENTS
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INTRODUCTION
All references to “Sol-Gel,” “Sol-Gel Technologies,”
“we,” “us,” “our,” “the Company” and similar designations refer to Sol-Gel Technologies
Ltd. The terms “shekels,” “Israeli shekels” and “NIS” refer to New Israeli Shekels, the lawful currency
of the State of Israel, the terms “dollar,” “US$” or “$” refer to U.S. dollars, the lawful currency
of the United States. Unless derived from our financial statements or otherwise indicated, U.S. dollar translations of NIS amounts presented
in this annual report are translated using the rate of NIS 3.647, NIS 3.627 and NIS 3.519 to $1.00, based on the exchange rates reported
by the Bank of Israel on December 31, 2024, December 31, 2023 and December 31, 2022, respectively.
References to the terms below in this Annual Report have
the meanings referred to below:
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“SGT-610” - SGT-610 (patidegib), an investigational topical treatment designed to prevent new Basel Cell Carcinomas (BCCs)
formation in adults with Gorlin Syndrome; |
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“SGT-210” - SGT-210 (erlotinib), an investigational topical ointment for the treatment of rare hyperkeratinization disorders;
“erlotinib” refers to an epidermal growth factor receptor inhibitor; |
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“Twyneo” - our novel, once-daily, non-antibiotic topical cream that has been approved by the Food and Drug Administration
for the treatment of acne vulgaris, or acne; |
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“Epsolay” - our novel, once-daily topical cream containing encapsulated benzoyl peroxide that has been approved by the
Food and Drug Administration for the treatment of papulopustular (subtype II) rosacea; |
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“approved products” - Twyneo and Epsolay; |
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“product candidates” - SGT-610 and SGT-210; and |
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“our products” - both approved products and product candidates. |
Solely for convenience, the trademarks, service marks, and
trade names referred to in this annual report are without the ® and ™ symbols, but such references are not intended to indicate,
in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensors
to these trademarks, service marks and trade names. This annual report contains additional trademarks, service marks and trade names of
others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this annual report
are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks,
service marks or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
This annual report includes statistics and other data relating
to markets, market sizes and other industry data pertaining to our business that we have obtained from industry publications and surveys
and other information available to us. Industry publications and surveys generally state that the information contained therein has been
obtained from sources believed to be reliable. Market data and statistics are inherently predictive and speculative and are not necessarily
reflective of actual market conditions. Such statistics are based on market research, which itself is based on sampling and subjective
judgments by both the researchers and the respondents, including judgments about what types of products and transactions should be included
in the relevant market. In addition, the value of comparisons of statistics for different markets is limited by many factors, including
that (i) the markets are defined differently, (ii) the underlying information was gathered by different methods, and (iii) different
assumptions were applied in compiling the data. Accordingly, the market statistics included in this annual report should be viewed with
caution. We believe that information from these industry publications included in this annual report is reliable.
1
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
Certain information included in this annual report on Form 20-F
may be deemed to be “forward-looking statements,” including some of the statements made under Item 3.D. “Risk Factors,”
Item 5 “Operating and Financial Review and Prospects,” “Business” and elsewhere in this annual report constitute
forward-looking statements. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,”
“will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,”
“predict,” “should,” “intend,” “project” or other similar words, but are not the only
way these statements are identified.
These forward-looking statements may include, but are not limited
to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial
condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our products,
and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect,
project, believe or anticipate will or may occur in the future.
Forward-looking statements are not guarantees of future performance
and are subject to risks and uncertainties. Forward-looking statements are based on information we have when these statements are made
or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that
could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements.
Important factors that could cause such differences include, but are not limited to:
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the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding
the adequacy of our liquidity to pursue our complete business objectives; |
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the benefits of and projections of our future financial performance as a result of our development of SGT-610; |
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our ability to enroll patients in our clinical trials and the possibility that patients would discontinue their participation in
our clinical trials; |
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our ability to complete the development of our product candidates; |
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our ability to obtain the benefits associated with orphan drug designation, such as orphan drug exclusivity and, even if we do, that
exclusivity may not prevent the U.S. Food and Drug Administration, or FDA, or other comparable foreign regulatory authorities from approving
competing products; |
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the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their
product candidates; |
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our dependence on the success of Beimei Pharmaceutical Co. Ltd (“Beimei”) and Searchlight Pharma Inc. (“Searchlight”)
and our other licensees in commercializing our approved products in China, Canada and in other licensed territories, respectively;
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the ability of Sol-Gel and its licensees to obtain and maintain the regulatory approval of Twyneo and Epsolay in various territories;
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our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse
regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; |
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our ability to find suitable co-development, contract manufacturing and marketing partners to our products; |
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our ability to commercialize and launch our product candidates; |
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our ability to obtain and maintain adequate protection of our intellectual property; |
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our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost;
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acceptance of our products by healthcare professionals and patients; |
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the possibility that we may face third-party claims of intellectual property infringement; |
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intense competition in our industry, with competitors having substantially greater financial, technological, research and development,
regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; |
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potential product liability claims; |
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potential adverse federal, state and local government regulation in the United States, Europe, China or Israel; |
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our failure to maintain compliance with the Nasdaq Listing Rules; |
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the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity
to manufacture, sell and support the use of Twyneo, Epsolay and our product candidates; and |
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loss or retirement of key executives and research scientists. |
You should review carefully the risks and uncertainties described
under the heading “Risk Factors” in this annual report for a discussion of these and other risks that relate to our business
and investing in our ordinary shares. The forward-looking statements contained in this annual report are expressly qualified in their
entirety by this cautionary statement. Except as required by law, we undertake no obligation to update publicly any forward-looking statements
after the date of this annual report to conform these statements to actual results or to changes in our expectations.
Readers are urged to carefully review and consider the various
disclosures made throughout this annual report on Form 20-F which are designed to advise interested parties of the risks and factors that
may affect our business, financial condition, results of operations and prospects.
You should not put undue reliance on any forward-looking statements.
Any forward-looking statements in this annual report on Form 20-F are made as of the date hereof, and we undertake no obligation to publicly
update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required
by law.
3
SUMMARY OF RISK FACTORS
The following is a summary of some of the principal risks we face.
The list below is not exhaustive, and investors should read this “Risk factors” section in full.
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We are a dermatology company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable
future and may never achieve or maintain profitability. |
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We may need substantial additional funding to pursue our business objectives. If we are unable to raise capital when needed, we could
be forced to curtail our planned operations and the pursuit of our growth strategy. If we are successful in raising additional capital,
this may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or products.
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Under our agreement with Mayne Pharma Group Limited (“Mayne”), Mayne is obligated to pay us an amount of $6,000,000 within
180 days of execution of the agreement. If Mayne fails to timely make this payment, our operational capabilities, including our ability
to complete clinical trials for SGT-610, will be jeopardized. Such failure could materially and adversely impact our financial position,
delay our product development, and significantly hinder our overall business objectives. |
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All of our product candidates are in development stage; therefore, we have not yet obtained regulatory approval for our product candidates
in the United States or any other country. |
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We are dependent on the success of Twyneo, Epsolay and our product candidates for the treatment of topical dermatological conditions.
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Our business is highly dependent on market perception of us and the safety and quality of Twyneo, Epsolay and our product candidates,
if approved. Our business or products could be subject to negative publicity, which could have a material adverse effect on our business.
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Although we have entered into exclusive license agreements with Beimei, Searchlight, and other licensees for China, Canadian and
other territories commercial activities for Twyneo and Epsolay, we have a limited operating history in the dermatological prescription
drug space which may makes it difficult to evaluate the success of our business to date and to assess our future viability. |
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Twyneo, Epsolay and our product candidates, even if they receive regulatory approval, may fail to achieve the broad degree of physician
adoption and market acceptance necessary for commercial success. |
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Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and
clinical trials may not be predictive of future trial results, which could result in development delays or a failure to obtain marketing
approval. |
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We may find it difficult to enroll patients in our clinical trials, and patients could discontinue their participation in our or
our collaborators’ clinical trials, which could delay or prevent clinical trials for our product candidates. |
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Twyneo and Epsolay, and our product candidates, if approved, will face, significant competition and our failure to compete effectively
may prevent us and our commercial partners from achieving significant market penetration and expansion. |
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We rely on commercialization partners to commercialize Twyneo and Epsolay in China, Canada and other jurisdictions around the world
and may depend on other parties for commercialization of Twyneo and Epsolay in other jurisdictions outside of China and Canada, and the
development and commercialization of our product candidates, if approved. We also rely on our collaborators and licensees to provide us
with accurate reports in order for us to accurately report our royalty revenues and
sales-based milestone payments. Any collaborative arrangements that we have (including our agreements with Beimei and Searchlight) or
may establish in the future may not be successful or we may otherwise not realize the anticipated benefits from these collaborations.
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We and our partners rely on third parties and consultants to assist us in conducting our clinical trials. If these third parties
or consultants do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory
approval for or commercialize our product candidates and our business could be substantially harmed. |
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The manufacture of pharmaceutical products is complex, and manufacturers often encounter difficulties in production. If we, our partners,
or any of our third-party manufacturers encounter any difficulties, our ability to provide product candidates for clinical trials or our
approved products to patients, and the development or commercialization of our product candidates could be delayed or stopped. |
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We depend on our intellectual property, and our future success is dependent on our ability to protect our intellectual property and
not infringe on the rights of others. |
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If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others
to compete against us. |
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If we fail to maintain compliance with Nasdaq’s continued listing requirements, our shares may be delisted from the Nasdaq
Capital Market. |
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If we are not able to retain our key management, or attract and retain qualified scientific, technical and business personnel, our
ability to implement our business plan may be adversely affected. |
ITEM 1.
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS
AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. Selected Financial Data
[Reserved].
B. Capitalization and
Indebtedness
Not applicable.
C. Reasons
for the Offer and Use of Proceeds
Not applicable.
5
D. Risk Factors
You should carefully consider the risks we
describe below, in addition to the other information set forth elsewhere in this annual report, including our financial statements and
the related notes beginning on page F-1, before deciding to invest in our ordinary shares, or the “ordinary shares”. The risks
and uncertainties described below in this annual report on Form 20-F for the year ended December 31, 2024, are not the only risks facing
us. We may face additional risks and uncertainties not currently known to us or that we currently deem to be immaterial. Any of the risks
described below or incorporated by reference in this Form 20-F, and any such additional risks, could materially adversely affect our business,
financial condition or results of operations. In such case, you may lose all or part of your investment.
Risks Related to Our Business and Industry
We are a dermatology company and have incurred significant losses
since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
We are a dermatology company with a limited operating history. We have incurred
net losses since our formation in 1997. In particular, we incurred a loss of $27.2 million in 2023 and a loss of $10.6 million in 2024.
As of December 31, 2024, we had an accumulated deficit of $230.9 million. Our losses have resulted principally from expenses incurred
in research and development of Twyneo, Epsolay and our product candidates and from general and administrative expenses that we have incurred
while building our business infrastructure. We expect to continue to incur net losses for the foreseeable future as we continue to invest
in research and development and seek to obtain regulatory approval and commercialization of our product candidates. The extent of our
future operating losses and the timing of generating revenues and becoming profitable are highly uncertain, and we may never achieve or
sustain profitability.
We anticipate that our expenses will increase substantially as
we:
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complete Phase III clinical study of SGT-610; |
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continue the development of SGT-210 and continue the research and development of other future product candidates; |
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seek regulatory approvals for any product candidate that successfully completes clinical development; |
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establish commercial manufacturing capabilities through one or more contract manufacturing organizations to commercialize our approved
products; |
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maintain, expand and protect our intellectual property portfolio; |
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seek new drug candidates and expand our disease portfolio; |
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add clinical, scientific, operational, financial and management information systems and personnel, including personnel to support
our product development; and |
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experience any delays or encounter any issues with any of the above, including but not limited to failed studies, complex results,
safety issues or other regulatory challenges. |
We have financed our operations primarily through public offerings
in the U.S., private placements of equity securities and investments and loans from our controlling shareholder. To date, we have devoted
a significant portion of our financial resources and efforts to developing our products. Although we have received approval from the FDA
with respect to our marketing applications for Twyneo in 2021 and Epsolay in 2022, to succeed we must successfully develop and eventually
commercialize products that generate significant revenue. This will require us to be successful in a range of challenging activities,
including successfully commercializing our approved products, completing clinical trials for our product candidates, discovering and developing
additional product candidates, obtaining regulatory approval for any product candidates that successfully complete clinical trials, establishing
manufacturing and marketing capabilities and ultimately selling any product candidates for which we may obtain regulatory approval. We
are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never
generate revenue that is significant enough to achieve profitability.
6
Because of the numerous risks and uncertainties associated
with pharmaceutical products, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be
able to achieve profitability. If we are required by the FDA or other regulatory authorities to perform studies in addition to those we
currently anticipate, or if there are any delays in completing our clinical trials, our expenses could increase, and revenue could be
further delayed.
We may never achieve or sustain profitability on a quarterly or
annual basis. Our failure to sustain profitability would depress the market price of our ordinary shares and could impair our ability
to raise capital, expand our business, diversify our product offerings or continue our operations. A decline in the market price of our
ordinary shares also could cause you to lose all or a part of your investment.
We may need substantial additional
funding to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to curtail our planned operations
and the pursuit of our growth strategy.
Conducting pre-clinical studies and clinical trials is a time-consuming,
expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain
regulatory approval and achieve product sales of our product candidates. We expect to continue to incur significant expenses and operating
losses over the next several years as we conduct Phase III clinical studies for SGT-610 and continue the development of SGT-210. In addition,
Twyneo and Epsolay, and our product candidates, if approved, may not achieve commercial success. Revenue, if any, will be derived from
sales of Twyneo and Epsolay, and other product candidates, if approved. We have based this estimate on assumptions that may prove to be
wrong, and we could use our capital resources sooner than we currently expect.
Our future capital requirements will depend on many factors, including:
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the progress and results of our development activities for SGT-610 and SGT-210; |
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the cost of manufacturing clinical supplies and exhibition batches of our product candidates; |
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the timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product
candidates for which we receive marketing approval; |
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the amount of revenue received from commercial sales of Twyneo, Epsolay and, if any, from our product candidates for which we may
receive marketing approval; |
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the costs, timing and outcome of regulatory reviews of any of our product candidates; |
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property
rights and defending any intellectual property-related claims by third parties that we are infringing upon their intellectual property
rights; and |
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the extent to which we acquire or invest in businesses, product candidates and technologies, including entering into licensing or
collaboration arrangements for any of our product candidates. |
In order to continue our future operations, we will need to raise
additional capital until we become profitable. If we are unable to raise sufficient additional capital, we could be forced to curtail
our planned operations and the pursuit of our growth strategy.
Under our agreement with Mayne, Mayne is obligated
to pay us an amount of $6,000,000 within 180 days of execution of the agreement. If Mayne fails to timely make this payment, our operational
capabilities, including our ability to complete clinical trials for SGT-610, will be jeopardized. Such failure could materially and adversely
impact our financial position, delay our product development, and significantly hinder our overall business objectives.
In April 2025, we entered into a product purchase agreement with
Mayne, pursuant to which Mayne acquired all of our rights in the U.S. related to our products Twyneo and Epsolay. Under the terms of this
agreement, Mayne is obligated to pay us a total of $16,000,000, with the second payment of $6,000,000 due within 180 days of execution
of the agreement. There can be no assurance that Mayne will fulfill this obligation in a timely manner or at all. If Mayne fails to make
this payment when due, our financial condition and liquidity could be materially adversely affected. Specifically, our ability to continue
ongoing operations and to complete critical milestones, including the clinical trials for our product candidate SGT-610, may be compromised.
Such disruption could lead to delays in our product development timelines, increased operational costs, and the necessity to secure alternative
funding, which may not be available on favorable terms or at all. Consequently, our inability to receive the agreed-upon funds from Mayne
could significantly impair our ability to achieve our strategic business objectives, maintain competitive advantages, and meet market
expectations.
7
All of our current product candidates
are in development stage and we have not yet obtained regulatory approval for such product candidates in the United States or any
other country.
Although we have obtained regulatory approvals in the United States
for Twyneo and Epsolay, none of our current product candidates has obtained regulatory approval for sale in the United States or any other
country, and we cannot guarantee that our current or future product candidates will ever obtain such approvals. Our business is substantially
dependent on our ability to complete the development of, obtain regulatory approval for and successfully commercialize our product candidates
in a timely manner. We or our partners cannot commercialize our product candidates in the United States without first obtaining regulatory
approval to market each product candidate from the FDA. Similarly, we or our partners cannot commercialize product candidates outside
of the United States without obtaining regulatory approval from comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the commercial sale of
any product candidate for a target indication, we or our partners must demonstrate in pre-clinical studies and well-controlled clinical
trials that the product candidate is safe and effective for use for its target indication and that the related manufacturing facilities,
processes and controls are adequate and in substantial compliance with regulatory requirements. In the United States, we or our partners
are required to submit and obtain the FDA’s approval of a new drug application, or NDA, before marketing any product candidate.
An NDA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety
and efficacy for each desired indication and, when subject to the requirements of section 505(b)(2) of the Federal Food, Drug and Cosmetic
Act, or FDCA, we or our partners may rely in part on published scientific literature and/or the FDA’s prior findings of safety and
efficacy in its approvals of similar products. The NDA must also include significant information regarding the chemistry, manufacturing
and controls for the product candidate. The FDA will also inspect our or our partners manufacturing facilities to ensure that the facilities
can manufacture each product candidate that is the subject of an NDA, in compliance with current good manufacturing practice, or cGMP
requirements, and may inspect our or our partners clinical trial sites to ensure that the clinical trials conducted at the inspected site
were performed in accordance with good clinical practices, or GCP, and our or our partners clinical protocols.
Obtaining approval of an NDA is a lengthy, expensive and uncertain
process, and approval is never guaranteed. Upon submission of an NDA, the FDA must make an initial determination that the application
is sufficiently complete to accept the submission for filing. We cannot be certain that any submissions will be accepted for filing and
review by the FDA, or ultimately be approved. If an application is not accepted for review or approved, the FDA may require that we or
our partners conduct additional clinical trials or pre-clinical studies or take other actions before it will reconsider our or our partner’s
application. If the FDA requires us or our partners to provide additional studies or data to support such applications, we could incur
increased costs and delays in the marketing approval process, which may require us to expend more resources than anticipated or that we
have available. In addition, the FDA may not consider any additional information to be complete or sufficient to support approval.
To date, we have submitted two NDAs that were accepted for filing
by the FDA, one for Twyneo, and one for Epsolay, both of which were subsequently approved by the FDA.
Our current investigational product candidate SGT-610 is a new
chemical entity that has never been approved by the FDA and we believe we will be required to seek approval for such product candidates
through the FDA’s 505(b)(1) NDA pathway, which requires full reports of investigations of safety and effectiveness without reliance
on the FDA’s prior approval of another product candidate. We have never obtained approval of a product through the 505(b)(1) NDA
pathway and may never succeed in doing so. The FDA and comparable authorities in other countries have substantial discretion in the approval
process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional pre-clinical
studies, clinical trials or other data demonstrating the safety and effectiveness of our product candidates. If we are unable to submit
and obtain regulatory approval for our product candidates, we will not be able to commercialize or obtain revenue in connection with such
product candidates.
Regulatory authorities outside of the United States also have requirements
for approval of drugs for commercial sale with which we must comply prior to marketing our product candidates in those countries. Regulatory
requirements can vary widely from country to country and could delay or prevent the introduction of our product candidates. Clinical trials
conducted in one country may not be accepted by regulatory authorities in other countries, and obtaining regulatory approval in one country
does not mean that regulatory approval will be obtained in any other country. However, the failure to obtain regulatory approval in one
jurisdiction could have a negative impact on our ability to obtain approval in other jurisdictions. Approval processes vary among countries
and can involve additional product candidate testing, development, validation and additional administrative review periods. Seeking regulatory
approval outside of the United States could require additional chemical manufacturing control data, pre-clinical studies or clinical trials,
which could be costly and time consuming. Obtaining regulatory approval outside of the United States may include all of the risks associated
with obtaining FDA approval and potentially additional risks.
8
We are largely dependent on the
success of Twyneo, Epsolay and our product candidates, if approved, for
the treatment of topical dermatological conditions.
We have invested a majority of our efforts and financial resources
in the research and development of Twyneo and Epsolay. In April 2025, we sold our rights related to Twyneo and Epsolay in the U.S. to
Mayne, following the mutual termination by Sol-Gel and Galderma Holding SA (“Galderma”) of the exclusive five-year license
agreement in the U.S. for both products, which were entered into in June 2021. In May 2024, Beimei purchased and licensed
the exclusive rights to commercialize Twyneo in the mainland of China, Hong Kong, Macau, Taiwan and Israel.
We have also licensed the rights to commercialize Twyneo and Epsolay to various licensees in Canada, certain European countries, South
Africa and South Korea. These licensees have the exclusive right to, and are responsible for, all commercial activities in their respective
territories. The success of our business depends largely on the success of Beimei, Searchlight success and our other licensees in commercializing
Twyneo and Epsolay and our ability to fund, execute and complete the development of, obtain regulatory approval for and successfully commercialize
our product candidates in a timely manner.
Our business is highly dependent
on market perception of us and the safety and quality of Twyneo, Epsolay and our product candidates, if approved. Our business or products
could be subject to negative publicity, which could have a material adverse effect on our business.
Market perception of our business is very important, especially
market perception of the safety and quality of our products. If Twyneo, Epsolay any of our product candidates, or similar products
that other companies distribute, or third-party products from which our product candidates are derived, are subject to market withdrawal
or recall or are proven to be, or are claimed to be, harmful to consumers, it could have a material adverse effect on our business. Negative
publicity associated with product quality, illness or other adverse effects resulting from, or perceived to result from, our products
could have a material adverse impact on our business.
Additionally, continuing and increasingly sophisticated studies
of the proper utilization, safety and efficacy of pharmaceutical products are being conducted by the industry, government agencies and
others which could call into question the utilization, safety and efficacy of previously marketed products. In some cases, studies have
resulted, and may in the future result, in the discontinuance of product marketing or other costly risk management programs such as the
need for a patient registry.
Although we have entered into
exclusive license agreements with commercialization partners for commercial activities for Twyneo and Epsolay in the U.S., China,
Canada and other jurisdictions around the world, we have a limited operating history in the dermatological prescription drug space which
may make it difficult to evaluate the success of our business to date and to assess our future viability.
We have a limited operating history in the dermatological prescription
drug space and have focused much of our efforts, to date, on the research and development of our product candidates, rather than commercialization.
In April 2025, we sold our rights related to Twyneo and Epsolay in the U.S. to Mayne, following the mutual termination by Sol-Gel and
Galderma of the exclusive five-year license agreement in the U.S. for both products, which were entered into in June 2021. In June
2023, we entered into exclusive license agreements with Searchlight, pursuant to which Searchlight has the exclusive right, and is responsible
for all commercial activities for Twyneo and Epsolay in Canada, over a fifteen-year term that is renewable for subsequent five-year periods.
In May 2024, we entered into an asset purchase agreement with Beimei, pursuant to which Beimei purchased and licensed the rights to commercialize
and manufacture Twyneo in China, Hong Kong, Macau, Taiwan and Israel, and during 2024, we also entered into commercialization agreements
for commercialization of Twyneo and Epsolay in most European countries, South Africa and South Korea. We also expect to collaborate with
third parties that have sales and marketing experience in order to commercialize Twyneo and Epsolay in additional territories, and
our product candidates, if approved, in lieu of our own sales force and distribution systems. We cannot provide any assurances as
to when, if ever, we will obtain approvals from governmental authorities outside of the U.S. or generate sufficient revenues to achieve
sustained profitability. Our and our partners’ ability to successfully commercialize our approved products and product candidates,
if approved, and become profitable is subject to a number of challenges, including, among others, that:
| • |
we may not have adequate financial or other resources; |
| • |
we or our partners may not be able to manufacture our products in commercial quantities, in an adequate quality or at an acceptable
cost; |
| • |
we or our partners may not be able to establish adequate sales, marketing and distribution channels for our products; |
9
| • |
we or our partners may not be able to find suitable co-development, contract manufacturing or marketing partners; |
| • |
healthcare professionals and patients may not accept our products; |
| • |
we may not be aware of possible complications from the continued use of our product candidates since we have limited clinical experience
with respect to the actual use of our product candidates; |
| • |
changes in the market, new alliances between existing market participants and the entrance of new market participants may interfere
with our or our partners market penetration efforts; |
| • |
third-party payors may not agree to reimburse patients for any or all of the purchase price of our products, which may adversely
affect patients’ willingness to purchase our approved products or product candidates, once approved; |
| • |
uncertainty as to market demand may result in inefficient pricing of our approved products and product candidates, once approved;
|
| • |
we may face third-party claims of intellectual property infringement; |
| • |
we or our partners may fail to obtain and maintain regulatory approvals for our product candidates in our target markets or may face
adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; |
| • |
we are dependent upon the results of ongoing clinical trials relating to our product candidates and the products of our competitors;
|
| • |
we may become involved in lawsuits pertaining to our clinical trials; and |
| • |
we may experience delays due to shortages in supply and human resources resulting from geopolitical instability (for more information,
see “Item 3. Key Information – D. Risk Factors – Risks Related to Our Operations in Israel”). |
The occurrence of any one or more of these events may limit
our or our partners' ability to successfully commercialize our approved products and product candidates, once approved, which in turn
could have a material adverse effect on our business, financial condition and results of operations. Consequently, there can be no guaranty
of the accuracy of any predictions about our future success or viability.
Raising additional capital may cause dilution to our
shareholders, restrict our operations or require us to relinquish rights to our technologies or products.
Until such time, if ever, as we can generate substantial revenue,
we may finance our cash needs through a combination of equity offerings, debt financings and license and collaboration agreements. We
do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity
or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or
other preferences that adversely affect your rights as an ordinary shareholder. Debt financing and preferred equity financing, if available,
may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional
debt, making capital expenditures or declaring dividends.
If we raise additional funds through collaborations, strategic
alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to
our technologies, future revenue streams or our products or grant licenses on terms that may not be favorable to us. If we are unable
to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product
development or future commercialization efforts or grant rights to develop and market our products that we would otherwise prefer
to develop and market ourselves.
10
Risks Related to Development and Clinical Testing of Our Products
Clinical drug development involves
a lengthy and expensive process with an uncertain outcome, and results of earlier studies and clinical trials may not be predictive of
future trial results, which could result in development delays or a failure to obtain marketing approval.
Clinical testing of product candidates and the submission of NDAs
to the FDA is expensive, time consuming and has an inherently uncertain outcome. Failure can occur at any time during the clinical trial
process, even with active ingredients that have been previously approved by the FDA or comparable foreign regulatory authorities as safe
and effective. Favorable results in pre-clinical studies and early clinical trials for one or more of our product candidates may not be
predictive of similar results in future clinical trials for such product candidate. Also, interim results during a clinical trial do not
necessarily predict final results. Product candidates in later stages of clinical development may fail to show the desired safety and
efficacy traits despite having progressed through pre-clinical studies and initial clinical trials. A number of companies in the pharmaceutical
and biotechnology industries have suffered significant setbacks in clinical trials even after achieving promising results in early-stage
development. Accordingly, the results from the completed pre-clinical studies and clinical trials for our product candidates may not be
predictive of the results we may obtain in later stage trials for such product candidates. Our and our partners’ clinical trials
may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials.
Clinical trial results may be inconclusive, or contradicted by other clinical trials, particularly larger clinical trials. Moreover, clinical
data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed
satisfactorily in pre-clinical studies and clinical trials have nonetheless failed to obtain FDA, or other applicable regulatory agency,
approval for their product candidates.
We or our partners may experience delays in our clinical trials,
and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed
on schedule, if at all. Clinical trials can be delayed for a variety of reasons, including delays related to:
| • |
recruiting, screening and enrolling suitable patients to participate in a trial; |
| • |
having subjects complete a trial or return for post-treatment follow-up; |
| • |
inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation
of clinical trials; |
| • |
reaching a consensus with regulatory authorities on study design or implementation of clinical trials; |
| • |
obtaining regulatory authorization to commence a trial; |
| • |
reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms
of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; |
| • |
identifying, recruiting and training suitable clinical investigators; |
| • |
obtaining institutional review board, or IRB, or ethics committee approval at each site; |
| • |
clinical sites deviating from FDA regulations, or similar foreign requirements (where applicable), including GCPs, or the study protocol,
or dropping out of a trial; |
| • |
adding new clinical trial sites; |
| • |
occurrence of adverse events associated with the product candidate that are viewed to outweigh its potential benefits, or occurrence
of adverse events in trial of the same class of agents conducted by other companies; |
| • |
the cost of clinical trials of our product candidates being greater than we or our partners anticipate; |
| • |
transfer of manufacturing processes to larger-scale facilities operated by a contract manufacturing organization, or CMO, and delays
or failure by our or our partners CMOs or us to make any necessary changes to such manufacturing process; |
| • |
third parties being unwilling or unable to satisfy their contractual obligations to us; |
11
| • |
manufacturing sufficient quantities of a product candidate for use in clinical trials; |
| • |
damage to clinical supplies of a product candidate caused during storage and/or transportation; or |
| • |
changes in applicable government regulations or administrative actions. |
In addition, we may encounter delays if a clinical trial is suspended or terminated
by us, by the IRBs of the institutions in which such trials are being conducted, by the FDA or other regulatory authorities or if a data
safety monitoring board recommends that any such trial be suspended or terminated, as applicable. Such authorities may impose or recommend
such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory
requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities
resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from
using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.
If we or our partners experience delays in the completion of any clinical trial for our product candidates or if any clinical trials are
terminated, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of
these product candidates will be delayed.
Moreover, changes in regulatory requirements and guidance or unanticipated
events during our or our partners’ clinical trials may occur, as a result of which we or our partners may need to amend clinical
trial protocols. Amendments may require us or our partners to resubmit our clinical trial protocols for review and approval, which may
adversely affect the cost, timing and successful completion of a clinical trial. If we or our partners experience delays in the completion
of, or if we or our partners terminate, any of our clinical trials, the commercial prospects for our affected product candidates would
be harmed and our ability to generate product revenue would be delayed, possibly materially.
Any delays in completing our or our partners’ clinical
trials will increase our costs, slow down our product candidates’ development and regulatory review and approval processes and jeopardize
our or our partners ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial
condition and prospects significantly. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion
of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.
We may find it difficult to enroll patients
in our clinical trials, and any enrolled subjects could discontinue their participation in our or our collaborators’ clinical trials,
which could delay or prevent clinical trials for our product candidates.
Identifying and qualifying patients to participate in clinical
trials for our product candidates is critical to our success. The timing of our clinical trials depends on the speed at which we or our
partners can recruit patients to participate in testing our product candidates. The indications we are currently pursuing include orphan
diseases (including Gorlin syndrome) for which the patient population is significantly small. If we are unable to locate qualified patients
or if patients are unwilling to participate in our clinical trials because of negative publicity from adverse events in the biotechnology
or pharmaceutical industries or for other reasons, including competitive clinical trials for similar patient populations, the timeline
for recruiting patients, conducting clinical trials and obtaining regulatory approval of product candidates may be delayed. These delays
could result in increased costs, delays in advancing our product candidates' development, or termination of the clinical trials altogether.
Patient enrollment may be affected by numerous factors, including:
| • |
severity of the disease under investigation; |
| • |
size and nature of the patient population; |
| • |
eligibility criteria for the trial; |
| • |
design of the trial protocol; |
| • |
perceived risks and benefits of the product candidate under study; |
12
| • |
physicians’ and patients’ perceptions as to the potential advantages of the drug being studied in relation to other available
therapies, including any drugs that may be approved for the same indications we are investigating; |
| • |
proximity to and availability of clinical trial sites for prospective patients; |
| • |
our or our partners’ ability to recruit clinical trial investigators with the appropriate competencies and experience;
|
| • |
the operational efficiency of trial sites, including sufficient staffing; |
| • |
availability of competing therapies and clinical trials; and |
| • |
ability to monitor patients adequately during and after treatment. |
We face intense competition with regard to patient enrollment in
clinical trials from other dermatological companies which also seek to enroll subjects from the same patient populations. In addition,
subjects enrolled in our clinical trials may discontinue their participation at any time during the trial as a result of a number of factors,
including withdrawing their consent or experiencing adverse clinical events, which may or may not be judged related to our product candidates
under evaluation. Therefore, any negative results we may report in clinical trials may make it difficult or impossible to recruit and
retain subjects in other clinical trials of that same product candidate. The discontinuation of patients in any one of our trials may
cause us to delay or abandon our clinical trial or cause the results from that trial not to be positive or sufficient to support a filing
for regulatory approval of the applicable product candidate.
The regulatory approval processes
of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable
to obtain regulatory approval for our product candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA and comparable
foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous
factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type
and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development
and may vary among jurisdictions. Although the FDA has approved Twyneo and Epsolay for marketing, it is possible that Twyneo and Epsolay
will not receive approval from comparable foreign authorities, and that none of our existing product candidates or any product candidates
we may seek to develop in the future will ever obtain regulatory approval.
Our product candidates could fail to receive regulatory approval
for many reasons, including the following:
| • |
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
|
| • |
we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate
is safe and effective for its proposed indication; |
| • |
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory
authorities for approval; |
| • |
we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; |
13
| • |
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical
trials; |
| • |
the data collected from clinical trials of our product candidates may not be sufficient to support the submission of an NDA or other
submission or to obtain regulatory approval in the United States or elsewhere; |
| • |
the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party
manufacturers with which we contract for clinical and commercial supplies; or |
| • |
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner
rendering our clinical data insufficient for approval. |
This lengthy approval process as well as the unpredictability of
future clinical trial results may result in our failing to obtain regulatory approval to market our product candidates, which would significantly
harm our business, results of operations and prospects.
In addition, even if we were to obtain approval, regulatory authorities
may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to
charge for our product candidates, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve
a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization
of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.
We cannot be certain that Twyneo and Epsolay will receive approval
by foreign authorities or that any of our current or future product candidates will receive regulatory approval. If we do not receive
regulatory approvals for our product candidates, we may not be able to continue our development operations for such product candidates.
Our revenue will be dependent, to a significant extent, upon the size of the markets in the territories for which we gain regulatory approval.
If the markets for patients or indications that we are targeting are not as significant as we estimate, we may not generate significant
revenue from sales of such products, even if approved by the FDA or by comparable foreign authorities.
Adverse side effects or other
safety risks associated with our approved products or our product candidates could delay or preclude approval or cause us to suspend or
discontinue clinical trials or abandon products. Adverse side effects or other safety risks associated with our approved products, could
limit their commercial profile.
Undesirable side effects caused by our product candidates could
result in the delay, suspension or termination of clinical trials by us, our collaborators, the FDA or other regulatory authorities for
a number of reasons. Results of our clinical trials for product candidates could reveal a high and unacceptable severity and prevalence
of these or other side effects. In such an event, our clinical trials could be suspended or terminated, and the FDA or comparable foreign
regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted
indications. The drug-related side effects could affect patient recruitment or the ability of enrolled subjects to complete the trial
or result in potential product liability claims. If we or our partners elect or are required to delay, suspend or terminate any clinical
trial for any product candidates, the commercial prospects of such product candidates will be harmed and our ability to generate product
revenues from any of these product candidates will be delayed or eliminated. Any of these occurrences may harm our business, prospects,
financial condition and results of operations significantly.
14
Additionally, with respect to our approved products and any one
or more of our products, for which we obtain regulatory approval, if we or others later identify undesirable side effects caused by such
products, a number of potentially significant negative consequences could result, including:
| • |
regulatory authorities may withdraw or limit their approvals of such products; |
| • |
regulatory authorities may require additional warnings on the label, including a “Boxed” Warning or contraindication;
|
| • |
we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; |
| • |
we may be required to implement a risk evaluation and mitigation strategy, or REMS, which may include a medication guide or patient
package insert, a communication plan to educate healthcare providers of the drug’s risks, or other elements to assure safe use;
|
| • |
we or our partners may be subject to regulatory investigations and government enforcement actions; |
| • |
the FDA or a comparable foreign regulatory authority may require us or our partners to conduct additional clinical trials or costly
post-marketing testing and surveillance to monitor the safety and efficacy of the product; |
| • |
the Company may decide to recall the affected product; |
| • |
we could be sued and held liable for harm caused to patients; and |
| • |
our reputation may suffer. |
Any of these events could prevent us from achieving or maintaining
market acceptance of our products, and could significantly harm our business, results of operations and prospects.
There is a substantial risk of
product liability claims in our business, and a product liability claim against us could adversely affect our business.
Our business exposes us to significant potential product liability
risks that are inherent in the development, manufacturing and marketing of pharmaceutical products. Product liability claims could delay
or prevent completion of our development and commercialization programs. Such claims could result in a recall of our products or a change
in the approved indications for which they may be used. While we maintain product liability insurance that we believe is adequate for
our operations, such coverage may not be adequate to cover any incident or all incidents. Furthermore, product liability insurance is
becoming increasingly expensive. As a result, we may be unable to maintain sufficient insurance at a reasonable cost to protect us against
losses that could have a material adverse effect on our business. These liabilities could prevent or interfere with our product development
and commercialization efforts.
15
We expect to utilize the FDA’s Section
505(b)(2) pathway for some of our product candidates and if that pathway is not available, the development of such product candidates
will likely take significantly longer, cost significantly more and entail significantly greater complexity and risk than currently anticipated,
and, in any case, may not be successful.
We intend to develop and seek approval for some of our product
candidates pursuant to the FDA’s 505(b)(2) NDA pathway. If the FDA determines that we may not use this regulatory pathway, then
we would need to seek regulatory approval via a “full” or “stand-alone” NDA under Section 505(b)(1) of the FDCA.
This would require us to conduct additional clinical trials and nonclinical testing, provide additional safety and efficacy data and other
information, and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to
obtain FDA approval, as well as the development complexity and risk associated with these programs, would likely substantially increase,
which could have a material adverse effect on our business and financial condition.
The Drug Price Competition and Patent Term Restoration Act of 1984,
informally known as the Hatch-Waxman Act, added Section 505(b)(2) to the FDCA. Section 505(b)(2) permits the filing of an NDA where at
least some of the information required for approval comes from studies and information that were not conducted by or for the applicant
and for which the applicant has not obtained a right of reference. Section 505(b)(2), if applicable to certain of our product candidates
under the FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions
regarding the safety and effectiveness of approved compounds, which could expedite our development programs relative to seeking approval
under the 505(b)(1) regulatory pathway.
If the FDA changes its 505(b)(2) policies and practices or if Congress
were to amend the statute to alter the currently available regulatory pathway, it could delay or even prevent the FDA from approving any
NDA we submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are
subject to special requirements designed to protect the patent rights of sponsors of previously approved drugs referenced in a Section
505(b)(2) NDA. Even if we are able to utilize the Section 505(b)(2) regulatory pathway for one or more of our candidates, there is no
guarantee this would ultimately lead to faster product development or earlier approval.
Moreover, any delay resulting from our inability to pursue the
FDA's 505(b)(2) pathway could result in new competitive products reaching the market more quickly than our product candidates, which may
have a material adverse impact on our competitive position and prospects. Even if we are allowed to pursue the FDA's 505(b)(2) pathway,
we cannot assure you that our product candidates will receive the requisite approvals for commercialization.
We may not be able to obtain the
benefits associated with orphan drug designation, such as orphan drug exclusivity and, even if we do, that exclusivity may not prevent
the FDA or other comparable foreign regulatory authorities from approving competing products.
Our product candidate, SGT-610, has obtained orphan drug designation
for the prevention of formation of BCC in patients diagnosed with Gorlin syndrome by both the FDA and the European Commission, or EC.
Regulatory authorities in these jurisdictions may designate drugs for relatively small patient populations as orphan drugs if the applicable
eligibility criteria are met, but there is no guarantee we will maintain the benefits of such designations.
In the United States, the FDA may designate a product as an orphan
drug if it is a drug intended to treat a rare disease or condition, which is defined as a patient population of fewer than 200,000 individuals
annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation
that the cost of developing and making available the drug will be recovered from sales in the United States. Orphan designation entitles
a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.
In addition, if a product that has orphan designation subsequently receives the first FDA approval for a particular active ingredient
for the rare disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity. Orphan exclusivity
in the United States provides that the FDA may not approve any other applications, including a full NDA, to market the same drug for the
same rare disease or condition for seven years, except in limited circumstances such as a showing of clinical superiority to the product
with orphan exclusivity or if FDA finds that the holder of the orphan exclusivity has not shown that it can ensure the availability of
sufficient quantities of the orphan drug to meet the needs of patients with the rare disease or condition for which the product was designated.
In the EU, the EC grants orphan designation on the basis of the
European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products scientific opinion. A medicinal product may be designated
as orphan if (1) it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition;
(2) either (a) such condition affects no more than five in 10,000 persons in the EU when the application is made, or (b) the product,
without the benefits derived from orphan status, would not generate sufficient return in the EU to justify investment; and (3) there exists
no satisfactory method of diagnosis, prevention or treatment, of such condition authorized for marketing in the EU, or if such a method
exists, the product will be of significant benefit to those affected by the condition. In the EU, orphan designation entitles a party
to financial incentives such as reduction of fees or fee waivers, protocol assistance, and access to the centralized marketing authorization
procedure. Moreover, upon grant of a marketing authorization and assuming the requirement for orphan designation are also met at the time
the marketing authorization is granted, orphan medicinal products are entitled to a ten-year period of market exclusivity for the approved
therapeutic indication. The period of market exclusivity is extended by two years for orphan medicinal products that have also complied
with an agreed Pediatric Investigation Plan, or PIP.
16
Even though our SGT-610 product candidate has obtained orphan drug
designation, we may not be able to obtain or maintain orphan drug exclusivity for this or any other future orphan designated product candidate.
We may not be the first to obtain marketing approval of any product candidate for which we have obtained designation in the specific rare
disease or condition due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights
in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost
if the FDA later determines that the request for designation was materially defective or if we are unable to ensure sufficient quantities
of the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity for
a product, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties
may be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve the same drug with the
same active moiety for the same disease or condition if the FDA concludes that the later drug is clinically superior in that it is shown
to be safer, more effective or makes a major contribution to patient care. In the EU, during the exclusivity period, marketing authorizations
may be granted to a similar medicinal product with the same orphan indication if: (i) the applicant can establish that the second medicinal
product, although similar to the orphan medicinal product already authorized is safer, more effective or otherwise clinically superior
to the orphan medicinal product already authorized; (ii) the marketing authorization holder for the orphan medicinal product grants its
consent; or (iii) if the marketing authorization holder of the orphan medicinal product is unable to supply sufficient quantities of product.
The European exclusivity period can be reduced to six years, if, at the end of the fifth year a medicine no longer meets the criteria
for orphan designation (i.e. the prevalence of the condition has increased above the orphan designation threshold or it is judged that
the product is sufficiently profitable so as not to justify maintenance of market exclusivity). Orphan drug designation neither shortens
the development time or regulatory review time of a drug nor gives the product candidate any advantage in the regulatory review or approval
process.
We may seek and fail to obtain fast track or
breakthrough therapy designations for our current or future product candidates. Even if we are successful, these programs may not lead
to a faster development or regulatory review process, they do not guarantee we will receive approval for any product candidate and the
FDA may later rescind fast track or breakthrough therapy designation if it believes a product candidate no longer meets the conditions
for qualification. We may also seek to obtain accelerated approval for one or more of our product candidates, but the FDA may disagree
that we have met the requirements for such approval.
If a product is intended for the treatment of a serious or life-threatening
condition and preclinical or clinical data demonstrate the potential to address an unmet medical need for this condition, the product
sponsor may apply for fast track designation. The sponsor of a fast track product candidate has opportunities for more frequent interactions
with the applicable FDA review team during product development and, once an NDA is submitted, the product candidate may be eligible for
priority review. A fast track product candidate may also be eligible for rolling review, where the FDA may consider for review sections
of the NDA on a rolling basis before the complete application is submitted. The FDA has broad discretion whether or not to grant
this designation, so even if we believe a particular product candidate is eligible for this designation, we cannot assure you that the
FDA would decide to grant it. Even if we do receive fast track designation for any of our product candidates, we may not experience a
faster development process, review or approval compared to conventional FDA procedures. The FDA may rescind the fast track designation
if it believes that the designation is no longer supported by data from our clinical development program.
Our product candidate SGT-610 has received Breakthrough Therapy
designation from the FDA, and we may also seek Breakthrough Therapy designation for other product candidates that we develop. A Breakthrough
Therapy is defined as a drug that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening
disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over currently
approved therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
For product candidates that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor
can help to identify the most efficient path for clinical development. Product candidates designated as breakthrough therapies by the
FDA may also be eligible for priority review. Like fast track designation, granting Breakthrough Therapy designation is within the discretion
of the FDA. Accordingly, even if we believe a product candidate we develop meets the criteria for designation as a Breakthrough Therapy,
the FDA may disagree and instead determine not to make such designation. In any event, the receipt of Breakthrough Therapy designation
for a product candidate, such as the designation for SGT-610, may not result in a faster development process, review or approval compared
to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even
if a product candidate we develop qualifies as a breakthrough therapy, the FDA may later decide that the drug no longer meets the conditions
for qualification and rescind the designation.
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Separate from fast track or breakthrough therapy designation, we
may seek accelerated approval for one or more of our product candidates. A product candidate intended to treat serious or life-threatening
diseases or conditions may be eligible for accelerated approval if it is determined to have an effect on a surrogate endpoint that is
reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality,
or IMM, that is reasonably likely to predict an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence
of the condition and the availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally
require the sponsor to perform adequate and well-controlled post-approval clinical studies to verify and describe the anticipated effect
on IMM or other clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit, or if the sponsor fails
to conduct the required studies in a diligent manner, the FDA may withdraw its approval of the drug on an expedited basis. We cannot guarantee
that the FDA will agree any of our product candidates has met the criteria to receive accelerated approval, which would require us to
conduct additional clinical testing prior to seeking FDA approval. Even if any of our product candidates receives approval through this
pathway, the required post-approval confirmatory clinical trials may fail to verify the predicted clinical benefit of the product, and
we may be required to remove the product from the market or amend the product label in a way that adversely impacts its marketing.
Twyneo, Epsolay and our product
candidates for which we obtain regulatory approval may continue to face future developmental and regulatory difficulties. In addition,
we and our partners will be subject to ongoing obligations and continued regulatory review.
Even if we complete clinical testing and receive approval of any for our product candidates,
the FDA may grant approval contingent on the performance of additional post-approval clinical trials, risk mitigation requirements such
as the implementation of a REMS, and/or surveillance requirements to monitor the safety or efficacy of the product. Any of these developments
could negatively impact us by reducing revenues or increasing expenses and cause the approved product candidate not to be commercially
viable. Absence of long-term safety data may further limit the approved uses of our product candidates, if any. Similar foreign
requirements may also apply in foreign jurisdictions.
The FDA or comparable foreign regulatory authorities also may approve
our product candidates for a more limited indication or a narrower patient population than we initially request or may not approve the
labeling that we believe is necessary or desirable for the successful commercialization of our product candidates. Furthermore, Twyneo
Epsolay, and any other product candidate for which we obtain approval will remain subject to extensive regulatory requirements, including
requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution and
recordkeeping. These requirements include registration with the FDA, listing of our product candidates, payment of annual fees, as well
as continued compliance with GCP requirements for any clinical trials that we or our partners conduct post-approval. Similar foreign requirements
may also apply in other jurisdictions. Application holders must notify the FDA, and depending on the nature of the change, obtain FDA
pre-approval for product manufacturing changes. In addition, manufacturers of drug products and their facilities are subject to continual
review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements.
If we or our partners fail to comply with the regulatory requirements
of the FDA or comparable foreign regulatory authorities or previously unknown problems with any approved commercial products, manufacturers
or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions or other setbacks, including
the following:
| • |
the FDA or comparable foreign regulatory authorities could suspend or impose restrictions on operations, including costly new
manufacturing requirements; |
| • |
the FDA or comparable foreign regulatory authorities could mandate modifications to promotional materials or require us to provide
corrective information to health care practitioners; |
| • |
the FDA or comparable foreign regulatory authorities could refuse to approve pending applications or supplements to applications;
|
| • |
the FDA or comparable foreign regulatory authorities could suspend any ongoing clinical trials; |
| • |
the FDA or comparable foreign regulatory authorities could suspend or withdraw marketing approval; |
| • |
the FDA or comparable foreign regulatory authorities could seek an injunction or impose civil or criminal penalties or monetary fines;
|
| • |
the FDA or comparable foreign regulatory authorities could ban or restrict imports and exports; |
| • |
the FDA or comparable foreign regulatory authorities could issue warning letters or untitled letters or similar enforcement actions
alleging noncompliance with regulatory requirements; |
18
| • |
governmental authorities could require a consent decree, which can include imposition of various fines, reimbursements for inspection
costs, required due dates for specific actions and penalties for noncompliance; or |
| • |
the FDA or other governmental authorities including comparable foreign regulatory authorities could take other actions, such as imposition
of product seizures or detentions, disgorgement, restitution, or exclusion from federal healthcare programs. |
In addition, our or our partners’ product labeling, advertising
and promotional materials for our approved products, if approved by the FDA, would be subject to regulatory requirements and continuing
review by the FDA. The FDA strictly regulates the promotional claims that may be made about prescription drug products. In particular,
a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling, a practice
known as off-label promotion. Similar requirements may apply in foreign jurisdictions. Physicians may nevertheless prescribe products
to their patients in a manner that is inconsistent with the approved label. If we are found to have promoted such off-label uses, we may
become subject to significant liability and government fines. The FDA and other foreign agencies actively enforce the laws and regulations
prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to
significant sanctions. The federal government has levied large civil and criminal fines against companies for alleged improper promotion
and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent
decrees or permanent injunctions under which specified promotional conduct is changed or curtailed.
Moreover, the FDA’s policies may change and additional government
regulations may be enacted that could prevent, limit or delay marketing approval of our product candidates, and the sale and promotion
of Twyneo, Epsolay and our product candidates, if approved. We also cannot predict the likelihood, nature or extent of government regulation
that may arise from future legislation or administrative action, either in the United States or abroad. For instance, the EU pharmaceutical
legislation is currently undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched
by the EC in November 2020. The EC’s proposal for revision of several legislative instruments related to medicinal products (potentially
reducing the duration of regulatory data protection, revising the eligibility for expedited pathways, etc.) was published on April 26,
2023. The proposed revisions remain to be agreed and adopted by the European Parliament and European Council and the proposals may therefore
be substantially revised before adoption, which is not anticipated before early 2026. The revisions may however have a significant impact
on the biopharmaceutical industry in the long term. If we are slow or unable to adapt to changes in existing requirements or the adoption
of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and
we may not achieve or sustain profitability.
Disruptions of funding for the FDA, the SEC
and other government agencies caused by funding shortages, mass layoffs, or global health concerns could hinder their ability to hire
and retain key leadership and other personnel, prevent our product candidates from being developed or commercialized in a timely manner
or otherwise prevent those agencies from performing normal business functions on which the operation of our business relies, which could
negatively impact our business.
The ability of the FDA to review and approve new products can
be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept
the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years
as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those
that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may also slow the
time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business.
For example, over the last several years, the United States government has shut down several times and certain regulatory agencies, such
as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities during that
period. In early 2025, following the inauguration of President Trump, the Trump Administration began terminating federal government employees,
including at the FDA. The impact of mass layoffs at the agency and other governmental offices with which we interact is unclear at this
time. However, it is expected that with a proposed reduction in staff of up to 50%, the FDA in the future may be unlikely to meet its
application review goals or to continue to be available for timely interactions with medical product developers. It is currently unclear
how the U.S. biopharmaceutical industry will be affected by the Trump Administration’s major changes to the FDA and the federal
government as a whole.
Separately, during the COVID-19 pandemic, the FDA postponed
most inspections of domestic and foreign manufacturing facilities at various points. Even though the FDA has since resumed standard inspection
operations of domestic facilities where feasible, the agency has continued to monitor and implement changes to its inspectional activities
to ensure the safety of its employees and those of the firms it regulates, and any resurgence of the virus or emergence of new infectious
disease outbreaks may lead to future inspectional delays. Regulatory authorities outside the United States may adopt similar policy measures
in response to emerging infectious disease outbreaks, epidemics, or pandemics. If a prolonged government shutdown or slowdown occurs,
or if global health concerns similar to COVID-19 prevent the FDA or other regulatory agencies from conducting their regular inspections,
review, or other regulatory activities, it could significantly affect the ability of the FDA to timely review and process our regulatory
submissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future government
shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue
our operations.
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Inadequate funding for the FDA, the SEC and other domestic and foreign
government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services
from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions
on which the operation of our business may rely, which could negatively impact our business.
The ability of the FDA to review and approve new products can be
affected by a variety of factors, including government budget and funding levels, its ability to hire and retain key personnel and accept
the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent
years as a result. In addition, government funding of the FDA, the SEC and other government agencies on which the Company’s operations
may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid
and unpredictable.
Future legislative and regulatory proposals may materially impact
the ability of the FDA and other regulatory agencies to operate as they have historically operated. We cannot be sure whether additional
legislative changes or executive orders will be enacted, or whether any of the FDA’s regulations, guidances or interpretations will
be changed, or what the impact of such changes on the agency and its scientific review staff, if any, may be. For example, the next FDA
user fee reauthorization package is expected to enter stakeholder negotiations beginning in mid-2025, with any agreement sent to Congress
in early 2027 for purposes of initiating the legislative process. Reauthorization of the prescription drug user fee program would need
to be finalized by Congress by the end of September 2027 in order to avoid disruptions in FDA’s review goals for NDAs and to other
activities supported by user fees assessed against industry.
In addition, disruptions at the FDA and other agencies may slow
the time necessary for clinical trial applications and/or marketing applications for new drugs to be reviewed or approved, which would
adversely affect the Company’s business. For example, political disputes in Congress may result in a shutdown of the U.S. government
and, in such cases, certain regulatory agencies, such as the FDA and the SEC, may have to furlough critical staff and stop critical activities.
If a prolonged government or slowdown shutdown occurs, it could significantly impact the ability of the FDA to timely review and process
the Company’s regulatory submissions, which could have a material adverse effect on the Company’s business.
Future government shutdowns or slowdowns could also result in delays
in our interactions with the SEC and other government agencies, which could impact our ability to access the public markets and obtain
necessary capital in order to properly capitalize and continue our operations.
Twyneo, Epsolay and our product
candidates, if they receive regulatory approval, may fail to achieve the broad degree of physician adoption and market acceptance necessary
for commercial success.
The commercial success of Twyneo Epsolay and our product candidates,
if approved, will depend significantly on their broad adoption by dermatologists, pediatricians and other physicians for approved indications
and other therapeutic or aesthetic indications for which we may seek approval from the FDA and other regulatory authorities.
The degree and rate of physician and patient adoption of Twyneo,
Epsolay and our product candidates, if approved, will depend on a number of factors, including:
| • |
the clinical indications for which the product is approved; |
| • |
the safety and efficacy of our product as compared to existing therapies for those indications; |
| • |
the prevalence and severity of adverse side effects; |
| • |
patient satisfaction with the results and administration of our product and overall treatment experience, including relative convenience,
ease of use and avoidance of, or reduction in, adverse side effects; |
| • |
patient demand for the treatment of acne and rosacea or other indications; |
20
| • |
the cost of treatment in relation to alternative treatments, the extent to which these costs are covered and reimbursed by third-party
payors, and patients’ willingness to pay for our products and product candidates, if approved; and |
| • |
the effectiveness of our sales and marketing efforts, including any head-to-head studies, if conducted, especially the success of
any targeted marketing efforts directed toward dermatologists, pediatricians, other physicians, clinics and any direct-to-consumer marketing
efforts we may initiate. |
We expend a significant amount of our resources on
research and development efforts that may not lead to successful product candidate introductions or the recovery of our research and development
expenditures.
We conduct research and development primarily to enable us
to manufacture and market topical dermatological drugs in accordance with FDA regulations as well as similar foreign requirements enforced
by foreign regulatory authorities. We spent approximately $12.7 million, $23.5 million and $17.8 million on research and development activities
during the years ended December 31, 2022, 2023 and 2024, respectively. We are required to obtain FDA and other regulatory authority
approvals before marketing our product candidates in the United States or in other jurisdictions. The regulatory authority approval process
is costly, time consuming and inherently risky, as is that applicable in other jurisdictions.
We cannot be certain that any investment made in developing product
candidates will be recovered, even if we are successful in commercialization. To the extent that we expend significant resources on research
and development efforts and are not able to introduce successful new product candidates as a result of those efforts, we will be unable
to recover those expenditures.
Our efficacy clinical trials for
Twyneo, Epsolay and our product candidates were not, and will not be, conducted head-to-head with the applicable leading products of our
competitors, and the comparison of our results to those of existing drugs, and the conclusions we have drawn from such comparisons, may
be inaccurate.
Our efficacy clinical trials for Twyneo, Epsolay and our
product candidates were not, and will not be, conducted head-to-head with the drugs considered the applicable standard of care for the
relevant indications. This means that none of the patient groups participating in these trials were, and will not in the future be, treated
with the applicable standard of care drugs alongside the groups treated with our product candidates. Instead, we have compared and plan
to continue comparing the results of our clinical trials with historical data from prior clinical trials conducted by third parties for
the applicable standard of care drugs, and which results are presented in their respective product labels.
Direct comparison generally provides more reliable information
about how two or more drugs compare, and reliance on indirect comparison for evaluating their relative efficacy or other qualities is
problematic due to lack of objective or validated methods to assess trial similarity. For example, the various trials were likely conducted
in different countries with different demographic features and in patients with different baseline conditions and different hygiene standards,
among other relevant asymmetries. Therefore, the conclusions we have drawn from comparing the results of our clinical trials with those
published in the product labels for these current standard of care drugs, including conclusions regarding the relative efficacy and expediency
of Twyneo and Epsolay, may be distorted by the inaccurate methodology of the comparison. Moreover, the FDA generally requires head-to-head
studies to make labeling and advertising claims regarding superiority or comparability, and our failure to collect head-to-head data may
limit the types of claims we may make for Twyneo, Epsolay and our product candidates for which we obtain approval.
We may be subject to risk as a
result of international manufacturing operations.
Twyneo, Epsolay and certain of our product candidates may be
manufactured, warehoused and/or tested at third-party facilities located in territories outside of Israel, in addition to our facility
in Israel, and therefore our operations are subject to risks inherent in doing business internationally. Such risks include the adverse
effects on operations from corruption, war, public health crises, such as pandemics and epidemics, international terrorism, civil disturbances,
political instability, governmental activities, deprivation of contract and property rights and currency valuation changes. Any of these
changes could have a material adverse effect on our reputation, business, financial condition or results of operations.
If in the future we acquire or
in-license technologies or additional product candidates, we may incur various costs, may have integration difficulties and may experience
other risks that could harm our business and results of operations.
In January 2023, we purchased assets related to our SGT-610 product candidate, which
included certain intellectual property rights owned by PellePharm Inc. (“PellePharm”) and licensed to PellePharm by Royalty
Security LLC. In the future, we may acquire or in-license additional potential products and technologies. Any potential product or technology
we in-license or acquire will likely require additional development efforts prior to commercial sale, including extensive pre-clinical
studies, clinical trials, or both, and approval by the FDA or other applicable foreign regulatory authorities, if any. All potential products
are prone to risks of failure inherent in pharmaceutical product development, including the possibility that the potential product, or
product developed based on in-licensed technology, will not be shown to be sufficiently safe and effective for approval by regulatory
authorities. If intellectual property related to potential products or technologies, we in-license or our own know-how is not adequate,
we may not be able to commercialize the affected potential products even after expending resources on their development. In addition,
we may not be able to manufacture economically or successfully commercialize any potential product that we develop based on acquired or
in-licensed technology that is granted regulatory approval, and such potential products may not gain wide acceptance or be competitive
in the marketplace. Moreover, integrating any newly acquired or in-licensed potential products could be expensive and time-consuming.
If we cannot effectively manage these aspects of our business strategy, our business may not succeed. Lastly, our license with Royalty
Security LLC requires us, and future in-license agreements will likely require us, to make payments and satisfy various performance obligations
in order to maintain our rights to our SGT-610 product candidate or other future product candidate, as the case may be. If we do
not satisfy our obligations under our agreement with Royalty Security LLC or under future in-license agreements, or if other events occur
that are not within our control, we could lose the rights to develop and commercialize our SGT-610 product candidate and other future
product candidate covered by such future in-license agreements.
21
Risks Related to Regulatory Matters
Healthcare reform in the
United States and the EU may harm our future business.
Changes in applicable U.S. federal and state laws and
agency regulation, as well as foreign laws and regulations, could have a materially negative impact on our business. In the United States
and in some other jurisdictions, there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare
system that could prevent or delay marketing approval of our product candidates or any potential future product candidates of ours, restrict
or regulate post-approval activities, or affect our ability to profitably sell any product candidates for which we obtain marketing approval.
Increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as
well as subject us to more stringent product labeling and post-marketing testing and other requirements. Congress also must reauthorize
the FDA’s user fee programs every five years and often makes changes to those programs in addition to policy or procedural changes
that may be negotiated between the FDA and industry stakeholders as part of this periodic reauthorization process. The next FDA user fee
reauthorization package is expected to enter stakeholder negotiations beginning in mid-2025, with any agreement sent to Congress in early
2027 for purposes of initiating the legislative process. Reauthorization of the prescription drug user fee program would need to be finalized
by Congress by the end of September 2027 in order to avoid a disruption in FDA’s review goals for BLAs and other activities supported
by user fees assessed against industry.
Among policy makers and payors in the United States and elsewhere,
there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving
quality and/or expanding access. In the United States, the pharmaceutical industry has been a focus of these efforts and has been significantly
affected by major legislative initiatives. In March 2010, Congress passed the Patient Protection and Affordable Care Act, as amended by
the Health Care and Education Reconciliation Act, collectively referred to as the ACA, which substantially changed the way healthcare
is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. We expect that changes
or additions to the ACA, the Medicare and Medicaid programs, and changes stemming from other healthcare reform measures, especially with
regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare
industry in the United States.
The Drug Supply Chain Security Act, or DSCSA, which became fully
effective and applicable in November 2024, imposes obligations on manufacturers of pharmaceutical products related to product tracking
and tracing. Furthermore, in February 2022, FDA released proposed regulations to amend the national standards for licensing of wholesale
drug distributors by the states; establish new minimum standards for state licensing third-party logistics providers; and create a federal
system for licensure for use in the absence of a state program, each of which is mandated by the DSCSA. Other legislative and regulatory
proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products.
We are unsure whether additional legislative changes will be enacted, or whether the current regulations, guidance or interpretations
will be changed, or whether such changes will have any impact on our business.
Additionally, there has been heightened governmental scrutiny
in the United States of biopharmaceutical pricing practices considering the rising cost of prescription drugs and biologics. Such scrutiny
has resulted in several recent congressional inquiries and proposed and enacted federal and state legislation designed to, among other
things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for products. For example, state legislatures are increasingly passing legislation and
implementing regulations designed to control pharmaceutical pricing, including price or patient reimbursement constraints, discounts,
restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage
importation from other countries and bulk purchasing. In December 2020, the U.S. Supreme Court held unanimously that federal law does
not preempt the states’ ability to regulate pharmaceutical benefit managers, or PBMs, and other members of the healthcare and pharmaceutical
supply chain, an important decision that may lead to further and more aggressive efforts by states in this area. Then, in mid-2022, the
Federal Trade Commission, or FTC, launched sweeping investigations into the practices of the PBM industry that could lead to additional
federal and state legislative or regulatory proposals targeting such entities’ operations, pharmacy networks, or financial arrangements.
In addition, in the last few years, several states have formed prescription drug affordability boards, or PDABs, with the authority to
implement upper payment limits, or UPLs, on drugs sold in their respective jurisdictions. There are several pending federal lawsuits challenging
the authority of states to impose UPLs, however.
In August 2022, the Inflation Reduction Act, or IRA, was signed
into law. The IRA includes multiple provisions that may impact the prices of drug products that are both sold into the Medicare program
and throughout the United States. For example, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay
a rebate to the federal government if the product’s price increases faster than the rate of inflation. This calculation is made
on a product-by-product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of a drug
product that is paid for by Medicare Parts B or D. Additionally, starting in payment year 2026, CMS will negotiate drug prices annually
for a select number of single source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices for a
select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected that
the revenue generated from such drug will decrease. Any additional federal or state healthcare reform measures could limit the amounts
that third-party payers will pay for healthcare products and services, and, in turn, could significantly reduce the projected value of
certain development projects and reduce our profitability.
22
In 2011, Directive 2011/24/EU was adopted at the EU level. This
Directive establishes a voluntary network of national authorities or bodies responsible for Health Technology Assessment (HTA) in the
individual EU member states. The network facilitates and supports the exchange of scientific information concerning HTAs. Further to this,
on December 13, 2021, Regulation No 2021/2282 on HTA, amending Directive 2011/24/EU, was adopted. While the Regulation entered into force
in January 2022, it will only begin to apply from January 2025 onwards, with preparatory and implementation-related steps to take place
in the interim. Once applicable, it will have a phased implementation depending on the concerned products. The Regulation intends to boost
cooperation among EU member states in assessing health technologies, including new medicinal products, and provide the basis for cooperation
at the EU level for joint clinical assessments in these areas. It will permit EU member states to use common HTA tools, methodologies,
and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies
with the highest potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities,
identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other
areas. Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects
of health technology, and making decisions on pricing and reimbursement.
In the EU, similar developments may affect our ability to profitably
commercialize our product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative
developments at the EU or member state level may result in significant additional requirements or obstacles that may increase our operating
costs. The delivery of healthcare in the EU, including the establishment and operation of health services and the pricing and reimbursement
of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National governments and health service providers
have different priorities and approaches to the delivery of health care and the pricing and reimbursement of products in that context.
In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions on the pricing and reimbursement
of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory burdens on those wishing to
develop and market products, this could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval
activities and affect our ability to commercialize our product candidates, if approved. In markets outside of the U.S. and EU, reimbursement
and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and
therapies.
Our employees may engage in misconduct or other improper activities,
including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
We are exposed to the risk of employee fraud or other misconduct,
including intentional failures to comply with FDA regulations or similar regulations of comparable foreign regulatory authorities, provide
accurate information to the FDA or comparable foreign regulatory authorities, comply with manufacturing standards we have established,
comply with federal and state health care fraud and abuse laws and regulations and similar laws and regulations established and enforced
by comparable foreign regulatory authorities, report financial information or data accurately or disclose unauthorized activities to us.
Employee misconduct could also involve the improper use of information obtained in the course of clinical trials, which could result in
regulatory sanctions and serious harm to our reputation. It is not always possible to identify and deter employee misconduct, and the
precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in
protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws
or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights,
those actions could have a significant impact on our business and results of operations, including the imposition of significant civil,
criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded health care programs, such as Medicare
and Medicaid, and integrity oversight and reporting obligations.
Risks Related to Commercialization
Our continued growth is dependent on our ability
to successfully develop new product candidates and commercialize our approved products and new product candidates, if approved, in a timely
manner.
Our financial results depend upon our ability to introduce and
commercialize additional product candidates in a timely manner. Generally, revenue from new innovative products increases following launch
and then following patent or exclusivity expiry, declines over time, as new competitors enter the market. Our growth is therefore dependent
upon our and our partners' ability to successfully commercialize our approved products and successfully introduce and commercialize our
product candidates, if approved.
The FDA and other foreign regulatory authorities may not approve
marketing applications at all or in a timely fashion for our product candidates under development. Additionally, we or our partners may
not successfully complete our development efforts for other reasons, such as poor results in clinical trials or a lack of funding to complete
the required trials. Even if the FDA or another foreign regulatory authority approves marketing applications for our product candidates,
we or our partners may not be able to market our products successfully or profitably. Our future results of operations will depend significantly
upon our or our partners' ability to timely develop, receive FDA or foreign regulatory authority approval for, and market our products
or otherwise develop new product candidates or acquire the rights to other products.
23
Twyneo and Epsolay face, and our
product candidates, if approved, will face, significant competition and our failure to compete effectively may prevent us from achieving
significant market penetration and expansion.
The facial aesthetic market in general, and the market for acne
and rosacea treatments in particular, are highly competitive and dynamic. Twyneo and Epsolay
face significant competition from other approved products, including topical anti-acne drugs such as Acanya, Ziana, Epiduo, Epiduo Forte,
Benzaclin, Aczone, Onexton, Differin, Arazlo, Aklief and Amzeeq, Winlevi and topical drugs for the treatment of rosacea such as Metrogel,
Finacea, Soolantraand Zilxi, oral drugs such as Solodyn, Doryx, Dynacin, Oracea and Minocin. Twyneo and Epsolay also competes with
non-prescription anti-acne products as well as unapproved and off-label treatments. In addition, Twyneo competes with drug products utilizing
other technologies that can separate two drug substances, such as dual chamber tubes, dual pouches or dual sachets. Competing in the facial
aesthetic market could result in price-cutting, reduced profit margins and loss of market share, any of which has and would harm our business,
financial condition and results of operations.
There are fewer limitations on the claims that our competitors
in international markets can make about the effectiveness of their products and the manner in which they can market them. As a result,
we may face more competition in markets outside of the United States.
In addition, we may not be able to price Twyneo, Epsolay, and our
product candidates, if approved, competitively with the current standards of care or other competing products for their respective indications
or their price may drop considerably due to factors outside our control. If this happens or the price of materials and the cost to manufacture
our product candidates increases dramatically, our ability to continue to operate our business would be materially harmed and we may be
unable to commercialize our product candidates, once approved, successfully.
We believe that our principal competitors are Bausch Health Companies,
Inc., Galderma S.A. (other than with respect to Twyneo and Epsolay, which it commercializes in the United States), Almirall, LLC and Sun
Pharmaceutical Industries Ltd. These competitors are large and experienced companies that enjoy significant competitive advantages
over us, such as greater financial, research and development, manufacturing, personnel and marketing resources, greater brand recognition,
and more experience and expertise in obtaining marketing approvals from the FDA and foreign regulatory authorities.
With respect to generic pharmaceutical products, the FDA approval
process often results in the FDA granting final approval to a number of ANDAs for a given product at the time a relevant patent for a
corresponding branded product or other regulatory and/or market exclusivity expires. As competition from other manufacturers intensifies,
selling prices and gross profit margins often decline. Accordingly, the level of market share, revenue and gross profit attributable to
a particular generic product that we develop is generally related to the number of competitors in that product’s market and the
timing of that product’s regulatory approval and commercial launch, in relation to competing approvals and launches. Additionally,
ANDA approvals often continue to be granted for a given product subsequent to the initial launch of the first generic product. These circumstances
generally result in significantly lower prices and reduced margins for generic products compared to brand products. New generic market
entrants generally cause continued price and margin erosion over the generic product life cycle.
In addition to the competition we face from other generic manufacturers,
we face competition from brand-name manufacturers related to our product candidates. Branded pharmaceutical companies may sell their branded
products as “authorized generics,” where an approved brand name drug is marketed, either by the brand name drug company or
by another company with the brand company’s permission, as a generic product without the brand name on its label, and potentially
sold at a lower price than the brand name drug. Further, branded pharmaceutical companies may seek to delay FDA approval of our 505(b)(2)
applications and ANDAs or reduce competition by, for example, obtaining new patents on drugs whose original patent protection is about
to expire, filing patent infringement suits that could delay FDA approval of 505(b)(2) and generic products, developing new versions of
their products to obtain FDA market exclusivity, filing citizen petitions contesting FDA approvals of 505(b)(2) and generic products such
as on alleged health and safety grounds, developing “next generation” versions of products that reduce demand for the 505(b)(2)
and generic versions we are developing, changing product claims and labeling, and seeking approval to market as OTC branded products.
Moreover, competitors may, upon the approval of an NDA, or an NDA
supplement, obtain a three-year period of exclusivity for a particular condition of approval, or change to a marketed product, such as
a new formulation for a previously approved product, if one or more new clinical trials (other than bioavailability or bioequivalence
studies) was essential to the approval of the application and was conducted/sponsored by the applicant. Such exclusivity may prevent the
FDA from approving one or more of our product candidates that are being developed, and for which we would seek the FDA’s approval
under the 505(b)(2) regulatory pathway, if we were to seek approval for the same conditions of approval as that protected by the period
of exclusivity. Recent litigation against the FDA has affirmed the FDA’s interpretation of the scope of exclusivity as preventing
the approval of a 505(b)(2) NDA for the same change to a previously approved drug, regardless of whether or not the 505(b)(2) applicant
relies on the competitor’s product as a listed drug in its 505(b)(2) application. Exclusivity determinations are highly fact-dependent
and are made by the FDA on a case-by-case basis at the end of the review period for a 505(b)(2) NDA. As such, we may not know until very
late in the FDA’s review of our 505(b)(2) product candidates whether or not approval may be delayed because of a competitor’s
period of exclusivity.
24
Other pharmaceutical companies
may develop competing products for acne, rosacea, Gorlin syndrome and other indications we are pursuing and enter the market ahead of
us.
Other pharmaceutical companies are engaged in developing, patenting,
manufacturing and marketing healthcare products that compete with those that we are developing. These potential competitors include large
and experienced companies that enjoy significant competitive advantages over us, such as greater financial, research and development,
manufacturing, personnel and marketing resources, greater brand recognition and more experience and expertise in obtaining marketing approvals
from the FDA and foreign regulatory authorities.
Several of these potential competitors are privately-owned
companies that are not bound by public disclosure requirements and closely guard their development plans, marketing strategies and other
trade secrets. Publicly-traded pharmaceutical companies are also able to maintain a certain degree of confidentiality over their pipeline
developments and other sensitive information. As a result, we do not know whether these potential competitors are already developing,
or plan to develop other topical treatments for acne, rosacea, BCC formation in patients with Gorlin syndrome, or other indications we
are pursuing, and we will likely be unable to ascertain whether such activities are underway in the future. These potential competitors
may therefore introduce competing products without our prior knowledge and without our ability to take preemptive measures in anticipation
of their commercial launch.
Furthermore, such potential competitors may enter the market before
us, and their products may be designed to circumvent our granted patents and pending patent applications. They may also challenge, narrow
or invalidate our granted patents or our patent applications, and such patents and patent applications may fail to provide adequate protection
for our product candidates.
Third-party payor coverage and
adequate reimbursement may not be available for Twyneo or Epsolay and our product candidates, once approved, which could make it difficult
for us or our partners to sell them profitably.
Sales of Twyneo, Epsolay, or our product candidates, if approved, will depend, in part,
on the extent to which the costs of our product candidates will be covered by third-party payors, such as government healthcare programs,
private health insurers and managed care organizations. Third-party payors generally decide which drugs they will cover for which indications
and establish certain reimbursement levels for such drugs. In particular, in the United States, private health insurers and other third-party
payors often provide reimbursement for products and services based on the level at which the government (typically through the Medicare
or Medicaid programs) provides reimbursement for such treatments. Patients who are prescribed treatments for their conditions and providers
performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients
are unlikely to use our products or product candidates, once approved, unless coverage is provided and reimbursement is adequate to cover
a significant portion of the cost of our products. Sales of Twyneo, Epsolay depend, and our product candidates, if approved, will depend,
substantially on the extent to which the costs of Twyneo, Epsolay and our product candidates will be paid by third-party payors. Additionally,
the market for Twyneo, Epsolay and our product candidates, if approved, will depend significantly on access to third-party payors’
formularies without prior authorization, step therapy, or other limitations such as approved lists of treatments for which third-party
payors provide coverage and reimbursement. If our products and our product candidates, if approved, are not included within an adequate
number of formularies or adequate reimbursement levels are not provided, or if those policies increasingly favor generic products, this
could have a material adverse effect on our business, financial condition, cash flows and results of operations or result in additional
pricing pressure on our products and product candidates. Coverage and reimbursement for therapeutic products can differ significantly
from payor to payor. One third-party payor’s decision to cover a particular medical product or service does not ensure that other
payors will also provide coverage for the medical product or service or will provide coverage at an adequate reimbursement rate. As a
result, the coverage determination process will require us to provide scientific and clinical support for the use of our products and
product candidates to each payor separately and will be a time-consuming process.
Third-party payors are developing increasingly sophisticated methods
of controlling healthcare costs and increasingly challenging the prices charged for medical products and services. Additionally, the containment
of healthcare costs has become a priority of federal and state governments and the prices of drugs have been a focus in this effort. The
United States government, state legislatures and foreign governments have shown significant interest in implementing cost-containment
programs, including price controls and transparency requirements, restrictions on reimbursement and requirements for substitution of generic
products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing
controls and measures, could limit our revenue and operating results. Additionally, policy efforts designed to reduce patient out-of-pocket
costs for medicines could result in new mandatory rebates and discounts or other pricing restrictions. If third-party payors do not consider
Twyneo, Epsolay or our product candidates, if approved, to be medically necessary or cost-effective compared to other therapies, they
may not cover Twyneo, Epsolay or our product candidates as a benefit under their plans or, if they do, the level of reimbursement may
not be sufficient to allow us or our partners to sell our products or our product candidates once approved on a profitable basis. Decreases
in third-party reimbursement for our products or our product candidates, if approved, or a decision by a third-party payor to not cover
our products or product candidates could reduce or eliminate utilization of our products or product candidates, and have an adverse
effect on our sales, results of operations and financial condition. In addition, state and federal healthcare reform measures have been
and may be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products
and services, and could result in reduced demand for our products and product candidates, if approved, or additional pricing
pressures.
Outside the United States, sales of any approved products are generally
subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment
initiatives in Europe and other countries has and will continue to put pressure on the pricing and usage of our products and product
candidates, if approved. In many countries, the prices of medicinal products are subject to varying price control mechanisms as part of
national health systems. Other countries allow companies to fix their own prices for medicinal products but monitor and control company
profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge
for our products and our product candidates, if approved. Accordingly, in markets outside the United States, the reimbursement for our
products and our product candidates, if approved, may be reduced compared with the United States and may be insufficient to generate commercially
reasonable revenue and profits.
25
Our current and future relationships
with investigators, health care professionals, consultants, third-party payors, and customers are subject to applicable healthcare regulatory
laws, which could expose us to penalties.
Our business operations and current and future arrangements with
investigators, healthcare professionals, consultants, third-party payors and customers, may expose us to broadly applicable fraud and
abuse and other healthcare laws and regulations. Healthcare providers, physicians and third-party payors in the United States and elsewhere
play a primary role in the recommendation and prescription of drug and biological products. Arrangements with third-party payors and customers
can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without
limitation, the federal Anti-Kickback Statute, or AKS, and the False Claims Act, or FCA, which may constrain the business or financial
arrangements and relationships through which such companies sell, market and distribute pharmaceutical products. In particular, the research
and development of any of our product candidates, as well as the promotion, sales and marketing of healthcare items and services, as well
as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing
and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion,
structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these
laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials.
The healthcare laws that may affect us or our partners include:
the federal fraud and abuse laws, including the AKS; false claims and civil monetary penalties laws, including the FCA and Civil Monetary
Penalties Law; federal data privacy and security laws, including HIPAA, as amended by the Health Information Technology for Economic and
Clinical Health, or HITECH, Act; and the federal Physician Payments Sunshine Act related to ownership and investment interests held by
physicians and their immediate family members, as well as payments and/or other transfers of value made to physicians, certain advanced
non-physician healthcare practitioners and teaching hospitals. In addition, many states have similar laws and regulations that may differ
from each other and federal law in significant ways, thus complicating compliance efforts. Moreover, several states require pharmaceutical
companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated
by the federal government and may require manufacturers to report information related to payments and other transfers of value to physicians
and other healthcare providers or marketing expenditures. Additionally, some state and local laws require the registration of pharmaceutical
sales representatives in the jurisdiction.
The scope and enforcement of each of these laws is uncertain and
subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations.
Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government
authorities, can be time- and resource-consuming and can divert a company’s attention from other aspects of its business.
Efforts to ensure that our current and future business arrangements
with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental
authorities will conclude that our business practices, or those of our partners, do not comply with current or future statutes, regulations,
agency guidance or case law involving applicable healthcare laws. If our or our partners’ operations are found to be in violation
of any of these or any other health regulatory laws that may apply to us, we and our partners may be subject to significant penalties,
including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, individual
imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs or similar programs in
other countries or jurisdictions, integrity oversight and reporting obligations to resolve allegations of non-compliance, contractual
damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could
adversely affect our ability to operate our business and our results of operations. Defending against any such actions can be costly,
time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against
any such actions that may be brought against us, our business may be impaired.
Actual or perceived failures to comply with
applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business,
results of operations, and financial condition.
The global data protection landscape is rapidly evolving, and
we are or may become subject to numerous state, federal and foreign laws, requirements and regulations governing the collection, use,
disclosure, retention, and security of personal information, such as information that we may collect in connection with clinical trials.
Any failure or perceived failure by us to comply with federal, state or foreign laws or regulations, our internal policies and procedures
or our contracts governing our processing of personal information could result in negative publicity, government investigations and enforcement
actions, claims by third parties and damage to our reputation, any of which could have a material adverse effect on our business, results
of operation, and financial condition.
26
In the U.S., HIPAA, as amended by the HITECH Act, and regulations
implemented thereunder, or collectively, HIPAA imposes obligations, including certain mandatory contractual terms, with respect to safeguarding
the privacy, security and transmission of individually identifiable health information. Most healthcare providers, including research
institutions from which we obtain patient health information, are subject to privacy and security regulations promulgated under HIPAA.
While we do not believe that we are currently acting as a covered entity or business associate under HIPAA and thus are not directly regulated
under HIPAA, we must structure our activities in compliance with these laws to ensure that we can access and use health information to
support our research, development and other activities. Our failure to comply with the data privacy and security principles set forth
in HIPAA, or a breach of health information or personal data, could prompt enforcement against our healthcare provider partners, create
third-party liability for our company and/or cause us significant financial or reputational harm. Specifically, depending on the facts
and circumstances, we could face substantial criminal penalties if we knowingly receive individually identifiable health information from
a HIPAA-covered healthcare provider or research institution that has not satisfied HIPAA’s requirements for disclosure of individually
identifiable health information.
Certain states have also adopted comparable privacy and security
laws and regulations, which govern the privacy, processing and protection of health-related and other personal information. Such laws
and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex
compliance issues for us and our future customers and strategic partners. For example, the California Consumer Privacy Act, as amended
by the California Privacy Rights Act, or collectively, the CCPA, requires certain businesses that process personal information of California
residents to, among other things: provide certain disclosures to California residents regarding the business’s collection, use,
and disclosure of their personal information; receive and respond to requests from California residents to access, delete, and correct
their personal information, or to opt-out of certain disclosures of their personal information; and enter into specific contractual provisions
with service providers that process California resident personal information on the business’s behalf. Similar laws have passed
in other states and are continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation
in the United States.
We are also subject to rapidly evolving data protection laws,
rules and regulations in foreign jurisdictions, including the EU General Data Protection Regulation, or GDPR, which went into effect in
May 2018 and imposes obligations and restrictions on the processing of personal data of individuals located in the European Economic Area,
or EEA, or in the context of our activities within the EEA. Companies that must comply with the GDPR face increased compliance obligations
and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to
€20 million or 4% of the annual global turnover of the noncompliant undertaking, whichever is greater. Further, the GDPR imposes
strict rules on the transfer of personal data out of the European Union to the United States and other regions that have not been deemed
to offer “adequate” privacy protection and the efficacy and longevity of current transfer mechanisms between the EEA, and
the United States remains uncertain. Case law from the Court of Justice of the European Union states that reliance on the standard contractual
clauses, or SCCs - a standard form of contract approved by the EC as an adequate personal data transfer mechanism - alone may not
necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis. On July 10, 2023, the EC adopted
its Adequacy Decision in relation to the new EU-U.S. Data Privacy Framework, or DPF, rendering the DPF effective as a GDPR transfer mechanism
to U.S. entities self-certified under the DPF. We expect the existing legal complexity and uncertainty regarding international personal
data transfers to continue. In particular, we expect the DPF Adequacy Decision to be challenged and international transfers to the United
States and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators. As supervisory authorities
issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking
enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise
unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide
our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial
results.
Additionally, following the United Kingdom’s withdrawal
from the European Union, we have to comply with the United Kingdom General Data Protection Regulation and Data Protection Act 2018, collectively,
the UK GDPR, which imposes separate but similar obligations to those under the GDPR and comparable penalties, including fines of up to
£17.5 million or 4% of a noncompliant undertaking’s global annual turnover, whichever is greater. On October 12, 2023, the
UK Extension to the DPF came into effect (as approved by the UK Government), as a data transfer mechanism from the UK to U.S. entities
self-certified under the DPF. The relationship between the United Kingdom and the European Union in relation to certain aspects of data
protection law remains unclear, for example around how data can lawfully be transferred between each jurisdiction, which exposes us to
further compliance risk.
Although we work to comply with applicable laws, regulations
and standards, our contractual obligations and other legal obligations, these requirements are evolving and may be modified, interpreted
and applied in an inconsistent manner from one jurisdiction to another, and may conflict with one another or other legal obligations with
which we must comply. Any failure or perceived failure by us or our employees, representatives, contractors, consultants, collaborators,
or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could
result in additional cost and liability to us, damage our reputation, and adversely affect our business and results of operations.
27
The illegal distribution and sale
by third parties of counterfeit versions of Twyneo, Epsolay or our product candidates or of stolen products could have a negative impact
on our reputation and a material adverse effect on our business, results of operations and financial condition.
Third parties could illegally distribute and sell counterfeit versions
of our products, which do not meet the rigorous manufacturing and testing standards that our products undergo. Counterfeit products are
frequently unsafe or ineffective and can be life-threatening. Counterfeit medicines may contain harmful substances, the wrong dose of
the active pharmaceutical ingredient or no active pharmaceutical ingredient at all. However, to distributors and users, counterfeit products
may be visually indistinguishable from the authentic version.
Reports of adverse reactions to counterfeit drugs similar to our
products or increased levels of counterfeiting such products could materially affect physician and patient confidence in our authentic
products. It is possible that adverse events caused by unsafe counterfeit products will mistakenly be attributed to our authentic products.
In addition, thefts of our inventory at warehouses, plant or while in-transit, which are not properly stored and which are sold through
unauthorized channels could adversely impact patient safety, our reputation and our business.
Public loss of confidence in the integrity of our products as a
result of counterfeiting or theft could have a material adverse effect on our business, financial position and results of operations.
Risks Related to Dependence on Third Parties
We rely on commercialization partners
to commercialize Twyneo and Epsolay in the U.S., China, Canada and other jurisdictions around the world and may depend on other parties
for commercialization of Twyneo and Epsolay outside of these jurisdictions, and the development and commercialization of our product candidates,
if approved. We also rely on our commercialization partners to provide
us with accurate reports in order for us to accurately report our royalty revenues and sales based milestone payments. Any collaborative
arrangements that we have or may establish in the future may not be successful or we may otherwise not realize the anticipated benefits
from these collaborations. We do not control third parties with whom we have or may have collaborative arrangements, and we will rely
on them to achieve results which may be significant to us. In addition, any current or future collaborative arrangements may place the
development and commercialization of our product candidates outside our control, may require us to relinquish important rights or may
otherwise be on terms unfavorable to us.
In June 2023, we entered into exclusive license agreements with
Searchlight, a private Canadian specialty pharmaceutical company, pursuant to which Searchlight has the exclusive right, and is responsible
for all commercial activities for Twyneo and Epsolay in Canada over a fifteen-year term that is renewable for subsequent five-year periods.
Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell the drugs in Canada
with support from us. In consideration for the grant of such rights, we will receive up to $11 million in potential upfront payments and
regulatory and sales milestones for both drugs, combined. In addition, we will be entitled to royalty percentages of all Canadian net
sales ranging from low-double-digits to high teens.
In May 2024, we entered into an asset purchase agreement with
Beimei, pursuant to which Beimei purchased and licensed the rights to commercialize and manufacture Twyneo in China, Hong Kong, Macau,
Taiwan and Israel. We expect to receive, subject to applicable government approvals, a total consideration of up to $15 million, out of
which $10 million will be paid as upfront and regulatory milestones, and the remaining $5 million will be paid as royalties on net sales.
During 2024, we also entered into commercialization agreements
for commercialization of Twyneo and Epsolay in most European countries, South Africa and South Korea.
28
We cannot and will
not control these third-party collaborators, but we rely on them to achieve results, which may be significant to us. Relying upon collaborative
arrangements to commercialize Twyneo, Epsolay and to develop and, if approved, commercialize our product candidates subjects us to a number
of risks, including:
| • |
we may not be able to control the amount and timing of resources that our collaborators may devote to Twyneo, Epsolay and our product
candidates; |
| • |
our current or future collaborators’ partners may fail to secure adequate commercial supplies of Twyneo, Epsolay and our product
candidates, if approved; |
| • |
should a collaborator fail to comply with applicable laws, rules, or regulations when performing services for us, we could be held
liable for such violations; |
| • |
we may not be able to locate additional third-party partners for the commercialization of Twyneo and Epsolay for additional territories;
|
| • |
our current or future collaborators may fail to comply with local or any foreign health authorities’ laws and regulations,
and as a result, the receipt of a site manufacturing, export or import license may be delayed or withheld for an undefined period;
|
| • |
our current or future collaborators may experience financial difficulties or changes in business focus; |
| • |
our current or future collaborators’ partners may have a shortage of qualified personnel; |
| • |
we may be required to relinquish important rights, such as marketing and distribution rights; |
| • |
business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s
willingness or ability to complete its obligations under any arrangement; |
| • |
under certain circumstances, a collaborator could move forward with a competing product developed either independently or in collaboration
with others, including our competitors; |
| • |
our current or future collaborators may utilize our proprietary information in a way that could expose us to competitive harm; and
|
| • |
collaborative arrangements are often terminated or allowed to expire, which could delay the development and may increase the cost
of developing our product candidates. |
We also currently rely on our commercialization partners
to provide us with accurate reports in order for us to accurately report our royalty revenues and fixed transfer price and calculate our
rights to receive sales-based milestone payments. Royalty and fixed transfer price payments under our agreements with our collaborators
are calculated and paid in accordance with reports we receive from our collaborators, and we have limited audit rights and information
with respect to these reports. In August 2023, we revised previously reported revenue for the first quarter and revenue for the
due to a disruption in Galderma’s first quarter wholesaler ordering patterns ahead of Galderma’s implementation of a new enterprise
resource planning system, which impacted its standard forecasting procedures and its quarterly assessment of rebate accruals. We cannot
provide any assurance that future reports provided any third parties with whom we have or may have collaborative arrangements will be
accurate or timely provided. If the reports we receive from them are inaccurate or delayed, our ability to accurately and timely
report our royalty revenues, fixed transfer price and sales based milestone payments may be adversely affected.
29
In addition, if disputes arise between us and our collaborators,
it could result in the delay or termination of the development, manufacturing or commercialization of Twyneo and Epsolay, lead to protracted
and costly legal proceedings, or cause collaborators to act in their own interest, which may not be in our interest. As a result, there
can be no assurance that the collaborative arrangements that we have entered into, or may enter into in the future, will achieve their
intended goals.
If any of these scenarios materialize, they could have an adverse
effect on our business, financial condition or results of operations.
It may be desirable or essential to enter into agreements with
a collaborator who has greater financial resources or different expertise than us, but for which we are unable to find an appropriate
collaborator or are unable to do so on favorable terms with respect to our current of future product candidates. If we fail to enter into
such collaborative agreements on favorable terms, it could materially delay or impair our ability to develop and commercialize our product
candidates and increase the costs of development and commercialization of such product candidates.
We currently contract with third-party
manufacturers and suppliers for certain compounds and components necessary to produce our product candidates for clinical trials, and
for commercial scale of production of our approved products. Our products are manufactured by third party manufacturers that were identified
and qualified by us. This dependence on third-party manufacturers increases the risk that we or our partners may not have access to sufficient
quantities or such quantities at an acceptable cost, which could delay, prevent or impair our and our partners’ development or commercialization
efforts.
We and our partners currently rely on third parties for the manufacture
and supply of certain compounds and components necessary to produce our product candidates for our clinical trials, and to prepare for
and perform commercial scale production of product candidates and our approved products, including active ingredients and excipients used
in the formulation of our products , as well as primary and secondary packaging and labeling materials. We lack the resources and the
capability to manufacture our approved products or any of our product candidates on a large clinical or commercial scale, and we
expect that we and our partners will continue to rely on third parties to support commercial requirements for our products.
The facilities used by our contract manufacturers to manufacture
our products must be approved by the FDA pursuant to inspections that are conducted after we or our partners submit our marketing applications
to the FDA. As part of the development of Twyneo and Epsolay we qualified CMOs, the facilities of which have been approved by the FDA.
Our current and future potential collaborators commercializing Twyneo and Epsolay, engaged and will engage these CMOs for the commercial
supply of our approved products. We are completely dependent on our contract manufacturing partners for compliance with applicable current
good manufacturing practice, or cGMP, requirements applicable to the manufacture of both active drug substances and finished drug products.
If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements
of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. In addition,
beyond contractual provisions requiring substantial compliance with applicable laws and regulations, we have no control over the ability
of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. We are in the process of
ensuring that our CMOs’ facilities are properly qualified and approved to manufacture, store, and distribute our products, including
any product candidates for which we obtain regulatory approval, under the laws of the EU and other territories where we or our collaborators
plan to commercialize such products. However, there is no guarantee that our CMOs will succeed in attaining or maintaining such qualification
or approval for any jurisdiction. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture
of our product candidates, discovers evidence of significant non-compliance at any such facility, or imposes enforcement actions or restrictions
on any such facility in the future, we or our partners may need to find alternative manufacturing facilities, which would significantly
impact our or our partners ability to develop, obtain regulatory approval for or market Twyneo, Epsolay or our product candidates.
Reliance on third-party manufacturers and suppliers entails a number
of risks, including reliance on the third party for regulatory compliance and quality assurance, the possible breach of the manufacturing
or supply agreement by the third party, the possibility that the supply is inadequate or delayed, the risk that the third party may enter
the field and seek to compete and may no longer be willing to continue supplying, and the possible termination or nonrenewal of the agreement
by the third party at a time that is costly or inconvenient for us. If any of these risks transpire, we may be unable to timely retain
an alternate manufacturer or suppliers on acceptable terms and with sufficient quality standards and production capacity, or at all, which
may disrupt and delay our clinical trials for our product candidates or the manufacture and commercial sale of Twyneo, Epsolay, and our
product candidates, if approved.
Our failure or the failure of our third-party manufacturers and
suppliers to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties,
delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect supplies of our product candidates that we may develop. Any failure
or refusal to supply or any interruption in supply of the components for Twyneo, Epsolay or any of our product candidates could delay,
prevent or impair our clinical development or commercialization efforts.
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We and our partners rely on third
parties and consultants to assist us in conducting clinical trials. If these third parties or consultants do not successfully carry out
their contractual duties or meet expected deadlines, we or our partners may be unable to obtain regulatory approval for or commercialize
our product candidates and our business could be substantially harmed.
We and our partners do not have the ability to independently perform
all aspects of our anticipated pre-clinical studies and clinical trials. We and our partners rely on medical institutions, clinical investigators,
CROs, contract laboratories, collaborative partners and other third parties to assist us in conducting our clinical trials and studies
for our product candidates. The third parties with whom we and our partners contract for execution of our clinical trials play a significant
role in the conduct of these trials and the subsequent collection and analysis of data. However, these third parties are not employees,
and except for contractual duties and obligations, we and our partners have limited ability to control the amount or timing of resources
that they devote to our programs.
In addition, the execution of pre-clinical studies and clinical
trials, and the subsequent compilation and analysis of the data produced, require coordination among these various third parties. In order
for these functions to be carried out effectively and efficiently, it is imperative that these parties communicate and coordinate with
one another, which may prove difficult to achieve. Moreover, these third parties may also have relationships with other commercial entities,
some of which may compete with us. Our and our partner's agreement with these third parties may inevitably enable them to terminate such
agreements upon reasonable prior written notice under certain circumstances.
Although we and our partners rely on these third parties to conduct
certain aspects of our clinical trials and non-clinical studies, we remain responsible for ensuring that each of our and our partners
studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our and our partners
reliance on these third parties does not relieve us or our partners of our and our partners regulatory responsibilities. In particular,
the FDA and foreign regulatory authorities require any clinical trials involving our product candidates to comply with GCPs, which are
the regulations and standards for conducting, monitoring, recording and reporting the results of clinical trials to ensure that the data
and results are scientifically credible and accurate, and that the trial subjects are adequately informed of the potential risks of participating
in clinical trials. We and our partners also rely on our consultants to assist us in the execution, including data collection and analysis
of our and our partners' clinical trials. If we, our partners, or any of our and our partners third-party contractors fail to comply with
applicable GCPs, the clinical data generated in the clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory
authorities may require us or our partners to perform additional clinical trials before approving our marketing applications. We cannot
assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our or our partner's
clinical trials complies with GCP regulations. In addition, our and our partners' clinical trials must be conducted with product manufactured
under cGMP regulations or similar foreign requirements. Any failure by us or our partners or any of our respective third-party contractors
to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
If the third parties or consultants that assist us and our partners
in conducting our clinical trials do not perform their contractual duties or obligations, experience work stoppages, do not meet expected
deadlines, terminate their agreements with us or our partners, or need to be replaced, or if the quality or accuracy of the clinical
data they obtain is compromised due to the failure to adhere to our clinical trial protocols, regulatory requirements or GCPs, or for
any other reason, we or our partners may need to conduct additional clinical trials or enter into new arrangements with alternative third
parties, which could be difficult, costly or impossible, and our or our partners clinical trials may be extended, delayed or terminated
or may need to be repeated. If any of the foregoing were to occur, we or our partners may not be able to obtain, or may be delayed in
obtaining, regulatory approval for the product candidates being tested in such trials, and will not be able to, or may be delayed in our
or our partners efforts to, successfully commercialize these product candidates, if approved.
The manufacture of pharmaceutical
products is complex, and manufacturers often encounter difficulties in production. If we or any of our third-party manufacturers encounter
any difficulties, our, or our partners’ ability to provide product candidates for clinical trials or our products or product candidates,
once approved, to patients, and the development or commercialization of our product candidates could be delayed or stopped.
The manufacture of pharmaceutical products is complex and requires
significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. We
and our or our partners’ contract manufacturers must comply with cGMP or similar requirements. Manufacturers of pharmaceutical products
often encounter difficulties in production, particularly in scaling up and validating initial production and contamination controls. These
problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance
testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations.
Furthermore, if microbial, viral or other contaminations are discovered in our products or in the manufacturing facilities in which our
products are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination.
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We cannot assure you that any stability or other issues relating
to the manufacture of any of our products will not occur in the future. Additionally, we, our partners and our third-party manufacturers
may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments.
If we, our partners, or our third-party manufacturers were to encounter any of these difficulties, our or our partners ability to provide
any product candidates to patients in clinical trials and approved products to patients would be jeopardized. Any delay or interruption
in the supply of clinical trial supplies could delay the initiation or completion of clinical trials, increase the costs associated with
maintaining clinical trial programs and, depending upon the period of delay, require us or our partners to commence new clinical trials
at additional expense or terminate clinical trials completely. Any adverse developments affecting clinical or commercial manufacturing
of our products may result in shipment delays, inventory shortages, lot failures, product withdrawals or recalls, or other interruptions
in the supply of our products. We may also have to take inventory write-offs and incur other charges and expenses for products that fail
to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Accordingly, failures or
difficulties faced at any level of our supply chain could materially adversely affect our business and delay or impede the development
and commercialization of any of our products and could have a material adverse effect on our business, prospects, financial condition
and results of operations.
Risks Related to Our Intellectual Property
We depend on our intellectual property, and our future
success is dependent on our ability to protect our intellectual property and not infringe on the rights of others.
Our success depends, in part, on our ability to obtain patent protection
for our products and product candidates, maintain the confidentiality of our trade secrets and know how, operate without infringing on
the proprietary rights of others and prevent others from infringing our proprietary rights. We try to protect our proprietary position
by, among other things, filing U.S., European, and other patent applications related to our products and product candidates, inventions
and improvements that may be important to the continuing development of our product candidates. While we generally apply for patents in
those countries where we intend to make, have made, use, or sell patented products, we may not accurately predict all of the countries
where patent protection will ultimately be desirable. If we fail to timely file a patent application in any such country, we may be precluded
from doing so at a later date. In addition, we cannot assure you that:
| • |
any of our future processes or product candidates will be patentable; |
| • |
our processes or products and product candidates will not infringe upon the patents of third parties; or |
| • |
we will have the resources to defend against charges of patent infringement or other violation or misappropriation of intellectual
property by third parties or to protect our own intellectual property rights against infringement, misappropriation or violation by third
parties. |
Because the patent position of pharmaceutical companies involves
complex legal and factual questions, we cannot predict the validity and enforceability of patents with certainty. Changes in either the
patent laws or in interpretations of patent laws may diminish the value of our intellectual property. Accordingly, we cannot predict the
breadth of claims that may be allowable or enforceable in our patents (including patents owned by or licensed to us). Our issued patents
may not provide us with any competitive advantages, may be held invalid or unenforceable as a result of legal challenges by third parties
or could be circumvented. Our competitors may also independently develop formulations, processes and technologies or products similar
to ours or design around or otherwise circumvent patents issued to, or licensed by, us. Thus, any patents that we own or license from
others may not provide any protection against competitors. Our pending patent applications, those we may file in the future or those we
may license from third parties may not result in patents being issued. If these patents are issued, they may not be of sufficient scope
to provide us with meaningful protection. The degree of future protection to be afforded by our proprietary rights is uncertain because
legal means afford relatively limited protection and may not adequately protect our rights or permit us to gain or keep our competitive
advantage.
Patent rights are territorial; thus, the patent protection we do
have will only extend to those countries in which we have issued patents. Even so, the laws of certain countries do not protect our intellectual
property rights to the same extent as do the laws of the United States and the European Union. Therefore, we cannot assure you that the
patents issued, if any, as a result of our foreign patent applications will have the same scope of coverage as our U.S. patents. Competitors
may successfully challenge our patents, produce similar drugs or products that do not infringe our patents, or produce drugs in countries
where we have not applied for patent protection or that do not respect our patents. Furthermore, it is not possible to know the scope
of claims that will be allowed in published applications and it is also not possible to know which claims of granted patents, if any,
will be deemed enforceable in a court of law.
32
After the completion of development and registration of our patents,
third parties may still act to manufacture and/or market products in infringement of our patent protected rights, and we may not have
adequate resources to enforce our patents. Any such manufacture and/or market of products in infringement of our patent protected rights
is likely to cause us damage and lead to a reduction in the prices of our products, thereby reducing our anticipated cash flows and profits,
if any.
In addition, due to the extensive time needed to develop, test
and obtain regulatory approval for our products, any patents that protect our products may expire early during commercialization. This
may reduce or eliminate any market advantages that such patents may give us. Following patent expiration, we may face increased competition
through the entry of competing products into the market and a subsequent decline in market share and profits.
We have granted, and may in the future grant, to third parties
licenses to use our intellectual property. Generally, other than the licenses granted to with respect to Twyneo and Epsolay, these licenses
have granted rights to commercialize products outside the pharmaceutical field or to technology we no longer use or to otherwise use our
intellectual property for a limited purpose outside the scope of our business interests. For example, in August 2013 we entered into an
assignment agreement with Medicis Pharmaceutical Corporation (“Medicis”), according to which Medicis assigned to us its entire
interest in one of the patents upon which we rely for Twyneo for the treatment of acne. As part of this assignment agreement, we
granted Medicis a non-exclusive, transferable, sub-licensable, royalty-free, perpetual, license to practice the inventions claimed under
the patent.
However, our business interests may change or our licensees may
disagree with the scope of our license grant. In such cases, such licensing arrangements may result in the development, manufacturing,
marketing and sale by our licensees of products substantially similar to our products, causing us to face increased competition, which
could reduce our market share and significantly harm our business, results of operations and prospects. Further, since many of our
license agreements are territory-specific, if a licensee breaches its obligations in one territory under a license agreement, another
licensee in a different territory may have a claim against us (as the licensor) for breach of contract or exclusivity, depending on the
specific terms of the agreement and the nature of the breach.
If we are unable to protect the
confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.
In addition to filing patent applications, we generally try to
protect our trade secrets, know-how, technology and other proprietary information by entering into confidentiality or non-disclosure agreements
with parties that have access to it, such as our development and/or commercialization partners, employees, contractors and consultants.
We also enter into agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries
and inventions of our employees, advisors, research collaborators, contractors and consultants while we employ or engage them. However,
we cannot assure you that these agreements will provide meaningful protection for our trade secrets, know-how or other proprietary information
in the event of any unauthorized use, misappropriation or disclosure of such trade secrets, know-how or other proprietary information
because these agreements can be difficult and costly to enforce or may not provide adequate remedies. Any of these parties may breach
the confidentiality agreements and willfully or unintentionally disclose our confidential information, or our competitors might learn
of the information in some other way. The disclosure to, or independent development by, a competitor of any trade secret, know-how or
other technology not protected by a patent could materially adversely affect any competitive advantage we may have over any such competitor.
To the extent that any of our employees, advisors, research collaborators,
contractors or consultants independently develop, or use independently developed, intellectual property in connection with any of our
projects, disputes may arise as to the proprietary rights to this type of information. If a dispute arises with respect to any proprietary
right, enforcement of our rights can be costly and unpredictable, and a court may determine that the right belongs to a third party.
33
Legal proceedings or third-party
claims of intellectual property infringement and other challenges may require us to spend substantial time and money and could prevent
us from developing or commercializing our products.
The development, manufacture, use, offer for sale, sale or importation
of our products may infringe on the claims of third-party patents or other intellectual property rights. The nature of claims contained
in unpublished patent filings around the world is unknown to us and it is not possible to know which countries patent holders may choose
for the extension of their filings under the Patent Cooperation Treaty, or other mechanisms. Therefore, there is a risk that we could
adopt a technology without knowledge of a pending patent application, which technology would infringe a third-party patent once that patent
is issued. We may also be subject to claims based on the actions of employees and consultants with respect to the usage or disclosure
of intellectual property learned at other employers. The cost to us of any intellectual property litigation or other infringement proceeding,
even if resolved in our favor, could be substantial. Any claims of patent infringement, even those without merit, could: be expensive
and time consuming to defend; cause us or our partners to cease making, licensing or using products that incorporate the challenged intellectual
property; require us or our partners to redesign, reengineer or rebrand our products and product candidates, if feasible; cause us to
stop from engaging in normal operations and activities, including developing and marketing our products and product candidates; and divert
management’s attention and resources. Some of our competitors may be able to sustain the costs of such litigation or proceedings
more effectively because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation
or defense of intellectual property litigation or other proceedings could have a material adverse effect on our ability to compete in
the marketplace. Intellectual property litigation and other proceedings may also absorb significant management time. Consequently, we
are unable to guarantee that we or our partners will be able to manufacture, use, offer for sale, sell or import our products in the event
of an infringement action.
In the event of patent infringement claims, or to avoid potential
claims, we or our partners may choose or be required to seek a license from a third party and would most likely be required to pay license
fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we or our partners were able to
obtain a license, the rights may be non-exclusive, which could potentially limit our competitive advantage. Ultimately, we or our partners
could be prevented from commercializing a product or be forced to cease some aspect of our business operations if, as a result of actual
or threatened patent infringement or other claims, we or our partners are unable to enter into licenses on acceptable terms. This inability
to enter into licenses could harm our business significantly.
In addition, because of our developmental stage, claims that our
products infringe on the patent rights of others are more likely to be asserted after commencement of commercial sales incorporating our
technology.
We may be subject to claims that
our or our partners' employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of
third parties or that our or our partners' employees have wrongfully used or disclosed alleged trade secrets of their former employers.
We employ individuals who were previously employed at universities
or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that
our employees, consultants, and independent contractors do not use the proprietary information or know-how of others in their work for
us, we may be subject to claims that we or our or our partners employees, consultants, or independent contractors have inadvertently or
otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our or our partners'
employees’ former employers or other third parties. Litigation may be necessary to defend against these claims. If we fail to defend
any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely
impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a
distraction to management and other employees.
Although we believe that we and our partners take reasonable steps
to protect our intellectual property, including the use of agreements relating to the non-disclosure of confidential information to third
parties, as well as agreements that purport to require the disclosure and assignment to us or our partners of the rights to the ideas,
developments, discoveries and inventions of our or our partners' employees and consultants while we or our partners employ them, the agreements
can be difficult and costly to enforce. Although we seek to obtain these types of agreements from our contractors, consultants, advisors
and research collaborators, to the extent that employees and consultants utilize or independently develop intellectual property in connection
with any of our projects, disputes may arise as to the intellectual property rights associated with our products. If a dispute arises,
a court may determine that the right belongs to a third party. In addition, enforcement of our rights can be costly and unpredictable.
We also rely on trade secrets and proprietary know-how that we seek to protect in part by confidentiality agreements with our employees,
contractors, consultants, advisors or others. Despite the protective measures we employ, we still face the risk that:
| • |
these agreements may be breached; |
| • |
these agreements may not provide adequate remedies for the applicable type of breach; |
| • |
our trade secrets or proprietary know-how will otherwise become known; or |
| • |
our competitors will independently develop similar technology or proprietary information. |
34
International patent protection
is particularly uncertain, and if we are involved in opposition proceedings in foreign countries, we may have to expend substantial sums
and management resources.
Patent law outside the United States may be different than in the
United States. Further, the laws of some foreign countries may not protect our intellectual property rights to the same extent as the
laws of the United States, if at all. A failure to obtain sufficient intellectual property protection in any foreign country could materially
and adversely affect our business, results of operations and future prospects. Moreover, we may participate in opposition proceedings
to determine the validity of our foreign patents or our competitors’ foreign patents, which could result in substantial costs and
divert management’s resources and attention. Additionally, due to uncertainty in patent protection law, we have not filed applications
in many countries where significant markets exist.
An NDA submitted under Section
505(b)(2) subjects us to the risk that we may be subject to a patent infringement lawsuit that would delay or prevent the review or approval
of our product candidates.
In the United States, we or our partners have filed and may in
the future file NDAs for our product candidates for approval under Section 505(b)(2) of the FDCA. Section 505(b)(2) permits the submission
of an NDA where at least some of the information required for approval comes from studies that were not conducted by, or for, the applicant
and on which the applicant has not obtained a right of reference. To date we have filed two NDAs under this section. In October 2020,
we submitted an NDA for marketing approval for Twyneo, which was granted by the FDA, and in June 2020, we submitted an NDA for marketing
approval for Epsolay, which was granted by the FDA. Both of these NDA’s were accepted for filing by the FDA. The FDA granted
marketing approval for Twyneo in July 2021, and for Epsolay in April 2022.
A 505(b)(2) application enables us to reference published literature
and/or the FDA’s previous findings of safety and effectiveness for the branded reference drug. For NDAs submitted under Section
505(b)(2) of the FDCA, the patent certification and related provisions of the Hatch-Waxman Act apply. In accordance with the Hatch-Waxman
Act, such NDAs may be required to include certifications, known as paragraph IV certifications, that certify that any patents listed in
the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange
Book, with respect to any product referenced in the 505(b)(2) application, are invalid, unenforceable or will not be infringed by the
manufacture, use or sale of the product that is the subject of the 505(b)(2) NDA. Applicants must also notify the holder of the approved
NDA for any product referenced in the 505(b)(2) application, along with all patent owners, regarding submission of a paragraph IV certification
with respect to applicable patents listed in the Orange Book.
Under the Hatch-Waxman Act, the NDA holder and patent owner(s)
may file a patent infringement lawsuit after receiving notice of the paragraph IV certification. Filing of a patent infringement lawsuit
against the filer of the 505(b)(2) application within 45 days of the patent owner’s receipt of notice triggers a one-time, automatic,
30-month stay of the FDA’s ability to approve the 505(b)(2) NDA, unless patent litigation is resolved in the favor of the paragraph
IV filer or the patent expires before that time. Accordingly, we or our partners may invest a significant amount of time and expense in
the development of one or more product candidates only to be subject to significant delay and patent litigation before such product candidates
may be commercialized, if at all. Further, although the Section 505(b)(1) regulatory pathway is not subject to the same patent certification
requirements as Section 505(b)(2) applications or ANDAs and is accordingly not associated with litigation under the Hatch-Waxman Act,
we may still face non-Hatch-Waxman patent litigation for products developed through the Section 505(b)(1) pathway.
In addition, a 505(b)(2) application will not be approved until
any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, or NCE, listed in the Orange Book for
the referenced product has expired. The FDA may also require us or our partners to perform one or more additional clinical trials or measurements
to support the change from the branded reference drug, which could be time consuming and could substantially delay our achievement of
regulatory approvals for such product candidates. The FDA may also reject our future 505(b)(2) submissions and require us or our partners
to file such submissions under Section 505(b)(1) of the FDCA, which would require us to provide extensive data to establish safety and
effectiveness of the drug for the proposed use and could cause delay and be considerably more expensive and time consuming. For products
we develop under the Section 505(b)(1) pathway, the FDA may disagree that our clinical data is sufficient for submission through this
pathway, which could result in our inability to seek approval for such products candidates. These factors, among others, may limit our
or our partners' ability to successfully commercialize our product candidates.
Companies that produce branded reference drugs routinely bring
litigation against ANDA or 505(b)(2) applicants that seek regulatory approval to manufacture and market generic and reformulated forms
of their branded products. These companies often allege patent infringement or other violations of intellectual property rights as the
basis for filing suit against an ANDA or 505(b)(2) applicant. Likewise, patent holders may bring patent infringement suits against companies
that are currently marketing and selling their approved generic or reformulated products.
Litigation to enforce or defend intellectual property rights is
often complex and often involves significant expense and can delay or prevent introduction or sale of our product candidates. If patents
are held to be valid and infringed by our product candidates in a particular jurisdiction, we or our partners would, unless we or our
partners could obtain a license from the patent holder, be required to cease selling in that jurisdiction and may need to relinquish or
destroy existing stock in that jurisdiction. There may also be situations where we and our partners use our business judgment and decide
to market and sell our approved product candidates, notwithstanding the fact that allegations of patent infringement(s) have not been
finally resolved by the courts, which is known as an “at-risk launch.” The risk involved in doing so can be substantial because
the remedies available to the owner of a patent for infringement may include, among other things, damages measured by the profits lost
by the patent owner and not necessarily by the profits earned by the infringer. In the case of a willful infringement, the definition
of which is subjective, such damages may be increased up to three times. Moreover, because of the discount pricing typically involved
with ANDA and, to a lesser extent, 505(b)(2), products, patented branded products generally realize a substantially higher profit margin
than ANDA and, to a lesser extent, 505(b)(2), products, resulting in disproportionate damages compared to any profits earned by the infringer.
An adverse decision in patent litigation could have a material adverse effect on our business, financial position and results of operations
and could cause the market value of our ordinary shares to decline.
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Risks Related to Our Operations in Israel
Our headquarters, manufacturing and other significant
operations are located in Israel and, therefore, our business and operations may be adversely affected by political, economic and military
conditions in Israel.
Our business and operations will be directly influenced by the
political, economic and military conditions affecting Israel at any given time. A change in the security and political situation in Israel
and in the economy could impede the raising of the funds required to finance our research and development plans and to create joint ventures
with third parties and could otherwise have a material adverse effect on our business, operating results and financial condition. Since
the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors,
including Hezbollah in Lebanon (and Syria) and Hamas in the Gaza Strip, both of which involved missile strikes in various parts of Israel
causing the disruption of economic activities. Our principal offices are located within the range of rockets that could be fired from
Lebanon, Syria or the Gaza Strip into Israel. In addition, Israel faces many threats from more distant neighbors, in particular, Iran.
Parties with whom we do business have sometimes declined to travel to Israel during periods of heightened unrest or tension, forcing us
to make alternative arrangements when necessary.
In October 2023, Hamas terrorists infiltrated Israel’s southern
border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks
on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State
of Israel. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and soldiers. Following the attack, Israel’s
security cabinet declared war against Hamas and commenced a military campaign against Hamas. In parallel, Hezbollah in Lebanon has also
launched missile, rocket, and shooting attacks against Israeli military sites, troops, and towns in northern Israel, and in response the
Israel Defense Forces commenced a military campaign against Hezbollah.
In addition, in April 2024 and October 2024, Iran (in concert with
other regional actors) launched direct attacks on Israel involving drones and missiles and is widely believed to be developing nuclear
weapons. Such attacks may continue due to continuing tensions in the region. Additionally, Yemeni rebel group, the Houthis, launched series
of attacks on global shipping routes in the Red Sea, causing disruptions of supply chain. These geopolitical developments may adversely
affect our ability to continue carrying out various administrative, research, operational and commercial functions and activities both
in Israel and globally. Further, as an Israeli company, there is heightened risk of cyberattacks on our and our supply chain’s IT
networks by our adversaries in general, and more so as a result of a war.
We currently do not anticipate any material risk to the Company
resulting from the current war although any escalation or expansion of the war could have a negative impact on both global and regional
conditions and may adversely affect our business, financial condition, and results of operations. Other than SGT-210, which is manufactured
in Israel and has not been impacted, all of the drug production for our products and investigational drug products has either been completed
or is conducted outside of Israel. In addition, the Phase III clinical trial for SGT-610 is being conducted in the U.S. and Europe and
while our Phase 1 clinical study of SGT-210 conducted in Israel, we currently do not expect a delay or disruption of this trial as a result
of the recent war. A delay or disruption in our Phase 1 trial of SGT-210 could impact the value of our securities and require us to raise
additional capital. If we are unable to do so on terms acceptable to us, we may be required to reduce our operating expenses and limit
our product development activities. See “- We may need substantial additional funding to pursue our business objectives. If
we are unable to raise capital when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.
Additionally, we cannot guarantee that the war will not deter potential investors from investing in Israeli companies such as ours, which
could in turn affect our business, operating results and financial condition. It is currently not possible to predict the duration or
severity of the ongoing conflict or its effect on our business, operations and financial conditions. The ongoing conflict is rapidly evolving
and developing and could disrupt our business and operations, interrupt our sources and availability of supply and hamper our ability
to raise additional funds or sell our securities, among other possible effects.
The political and security situation in Israel may result
in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments
under those agreements pursuant to force majeure provisions in such agreements. Any hostilities involving Israel or the interruption or
curtailment of trade between Israel and its present trading partners could result in damage to our facilities and likewise have a material
adverse effect on our business, operating results and financial condition. Furthermore, prior to Hamas attack in October 2023, the Israeli
government proposed extensive changes to Israel’s judicial system which sparked extensive political debate and unrest. In response
to the foregoing, individuals, organizations and institutions, both within and outside of Israel, voiced concerns that the proposed changes
may negatively impact the business environment in Israel. If such changes to Israel’s judicial system are again pursued by the government
and approved by the parliament, this may have an adverse effect on our business, our results of operations and our ability to raise additional
funds, if deemed necessary by our management and board of directors.
Several countries, principally in the Middle East, restrict doing
business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli
companies if hostilities in the region continue or intensify. Moreover, the perception of Israel and Israeli companies by the global
community (as represented, for example, by claims filed with the International Court of Justice (the “ICJ”), since the outbreak
of the current war) may cause an increase in sanctions and other adverse measures against Israel, Israeli companies and their products
and services. Additionally, there have been increased efforts by countries, activists and organizations to cause companies and consumers
to boycott Israeli goods and services or otherwise restrict business with Israel and with Israeli companies, which may impact our ability
to do business with our existing and potential customers. Such efforts, particularly if they become widespread, as well as current
and future rulings and orders of international tribunals (including the ICJ) against Israel, could materially and adversely impact our
business operations. Such restrictions may seriously limit our ability to sell Twyneo, Epsolay and our product candidates, if approved,
to customers in those countries.
Any hostilities involving Israel or the interruption or curtailment
of trade between Israel and its present trading partners, or significant downturns in the economic or financial condition of Israel, could
adversely affect our operations and product development, cause our revenues to decrease and adversely affect the share price of publicly
traded companies having operations in Israel, such as us. Our commercial insurance does not cover losses that may occur as a result of
an event associated with the security situation in the Middle East. Although the Israeli government is currently committed to covering
the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, there can be no assurance that this government
coverage will be maintained, or if maintained, will be sufficient to compensate us fully for damages incurred. Any losses or damages incurred
by us could have a material adverse effect on our business, financial condition and results of operations.
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Exchange rate fluctuations between
the U.S. dollar, the New Israeli Shekel and other foreign currencies, may negatively affect our future revenues.
In the future, we expect that a substantial portion of our revenues
will be generated in U.S. dollars, Euros and other foreign currencies, although we currently incur a significant portion of our expenses
in currencies other than U.S. dollars, and mainly in NIS. Our financial records are maintained, and will be maintained, in U.S. dollars,
which is our functional currency. As a result, our financial results may be affected by fluctuations in the exchange rates of currencies
in the countries in which Twyneo, Epsolay or our prospective product candidates, if approved, may be sold.
Our operations may be affected by negative labor
conditions in Israel.
Strikes and work-stoppages occur relatively frequently in Israel.
If Israeli trade unions threaten additional strikes or work-stoppages and such strikes or work-stoppages occur, those may, if prolonged,
have a material adverse effect on the Israeli economy and on our business, including our ability to deliver products to our customers
and to receive raw materials from our suppliers in a timely manner.
Our operations could be disrupted
as a result of the obligation of our personnel to perform military service.
Most of our executive officers and key employees reside in Israel
and, although most of them are no longer required to perform reserve duty, some may be required to perform annual military reserve duty
and may be called for active duty under emergency circumstances at any time. Our operations could be disrupted by the absence for a significant
period of time of one or more of these officers or key employees due to military service. Any such disruption could adversely affect our
business, results of operations and financial condition.
The termination or reduction of
tax and other incentives that the Israeli Government provides to domestic companies may increase the costs involved in operating a company
in Israel.
The Israeli government currently provides tax and capital investment
incentives to domestic companies, as well as grant and loan programs relating to research and development and marketing and export activities.
We may take advantage of these benefits and programs in the future; however, there is no assurance that such benefits and programs would
continue to be available in the future to us. If such benefits and programs were terminated or further reduced, it could have an adverse
effect on our business, operating results and financial condition.
The Israeli government grants that we have received for research
and development expenditures require us to meet several conditions and may restrict our ability to manufacture some of our product candidates
and transfer relevant know-how outside of Israel and require us to satisfy specified conditions.
We have received royalty-bearing grants from the government of
Israel through the National Authority for Technological Innovation, or the Israel Innovation Authority, also known as the IIA (formerly
known as the Office of the Chief Scientist of the Ministry of Economy and Industry, or the OCS), for the financing of a portion of our
research and development expenditures in Israel. These IIA grants relate to a peripheral line of product candidates which forms a negligible
part of our activities. We are required to pay the IIA royalties from the revenues generated from the sale of products (and related services)
developed (in all or in part), directly or indirectly, using the IIA grants we received as part of a research and development program
funded by the IIA, or the Approved Program, (at rates which are determined under the IIA rules), up to the aggregate amount of the total
grants received by the IIA, plus Annual Interest for a File (as defined under the IIA's rules). As we received grants from the IIA, we
are subject to certain restrictions under the Encouragement of Research, Development and Technological Innovation in the Industry Law
5744-1984, or the Innovation Law, the regulations promulgated thereunder and the IIA's rules and guidelines. These restrictions may impair
our ability to perform or outsource manufacturing of IIA funded products outside of Israel, granting licenses for R&D purposes or
otherwise transfer outside of Israel the know-how resulting, directly or indirectly, in whole or in part, in accordance with or as a result
of, research and development activities made according to an Approved Program, as well as any rights associated with such know-how (including
later developments, which derive from, are based on, or constitute improvements or modifications of such know-how), or the IIA Funded
Know-How.
The restrictions under the IIA’s rules and guidelines continue to apply even after
payment to the IIA of the full amount of royalties payable pursuant to the grants. In addition, the IIA may from time to time audit sales
of products which it claims incorporate IIA Funded Know-How and this may lead to additional royalties being payable on additional product
candidates and may subject such products to the restrictions and obligations specified hereunder. Following an audit conducted by the
IIA, the IIA confirmed to us that products based on encapsulation technology of solid material are exempt from royalty payment obligations
to the IIA. Twyneo and Epsolay fall within the category of products based on encapsulation technology of solid material. However, there
can be no guarantee that the IIA will not in the future attempt to claim royalties with respect to these products, or that future products
will not be subject to royalties.
37
These restrictions may impair our ability to perform or outsource
manufacturing rights of IIA funded products outside of Israel, or otherwise transfer or license for R&D purpose our IIA Funded Know-How
in and outside of Israel without the approval of the IIA, and we cannot be certain that any approval of the IIA will be obtained on terms
that are acceptable to us, or at all. Furthermore, in the event that we undertake a transaction involving the transfer to a non-Israeli
entity of IIA Funded Know-How pursuant to a merger or similar transaction, or in the event we undertake a transaction involving the licensing
of IIA Funded Know-How for R&D purposes to a non-Israeli entity, the consideration available to our shareholders may be reduced by
the amount we are required to pay to the IIA. Any approval, if given, will generally be subject to additional financial obligations. Failure
to comply with certain requirements under the IIA’s rules and guidelines and the Innovation Law may subject us to financial sanctions,
to mandatory repayment of grants received by us (together with interest and penalties), as well as may expose us to criminal proceedings.
Enforcing a U.S. judgment against us and our current
executive officers and directors, or asserting U.S. securities law claims in Israel, may be difficult.
We are incorporated in Israel. All of our current executive officers
and directors reside in Israel (other than two of our directors who reside in the United States) and most of our assets reside outside
of the United States. Therefore, a judgment obtained against us or any of these persons in the United States, including one based on the
civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States and may not be enforced by
an Israeli court. It may also be difficult to effect service of process on these persons in the United States or to assert U.S. securities
law claims in original actions instituted in Israel.
Even if an Israeli court agrees to hear such a claim, it may determine
that Israeli, and not U.S., law is applicable to the claim. Under Israeli law, if U.S. law is found to be applicable to such a claim,
the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process, and certain matters of
procedure would be governed by Israeli law. There is little binding case law in Israel addressing these matters.
Israeli law and tax considerations may delay, prevent
or make difficult an acquisition of us, which could prevent a change of control and negatively affect the price of our ordinary shares.
Israeli corporate law regulates mergers, requires tender offers
for acquisitions of shares above specified thresholds, requires special approvals for certain transactions involving directors, officers
or significant shareholders and regulates other matters that may be relevant to these types of transactions. These provisions of Israeli
law may delay, prevent or make difficult an acquisition of us, which could prevent a change of control and therefore depress the price
of our ordinary shares.
Furthermore, Israeli tax considerations may make potential transactions
unappealing to us or to our shareholders, especially for those shareholders whose country of residence does not have a tax treaty with
Israel which exempts such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax-free share exchanges to the
same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral
contingent on the fulfillment of a number of conditions, including, in some cases, a holding period of two years from the date of the
transaction during which sales and dispositions of shares of the participating companies are subject to certain restrictions. Moreover,
with respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the tax becomes payable
even if no disposition of the shares has occurred.
We may become subject to claims for remuneration
or royalties for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
We have entered into assignment of invention agreements with our
employees pursuant to which such individuals agree to assign to us all rights to any inventions created during and as a result of their
employment or engagement with us. A significant portion of our intellectual property has been developed by our employees in the course
of their employment for us. Under the Israeli Patents Law, 5727-1967, or the Patents Law, inventions conceived by an employee during the
scope of his or her employment with a company and as a result thereof are regarded as “service inventions,” which belong to
the employer, absent a specific agreement between the employee and employer giving the employee service invention rights. The Patents
Law also provides that if there is no agreement between an employer and an employee with respect to the employee’s right to receive
compensation for such “service inventions,” the Israeli Compensation and Royalties Committee, or the Committee, a body constituted
under the Patents Law, has the authority to determine whether the employee is entitled to remuneration for service inventions developed
by such employee and the scope and conditions for such remuneration. Case law clarifies that the right to receive consideration for “service
inventions” can be waived by the employee and that in certain circumstances, such waiver does not necessarily have to be explicit.
The Committee will examine, on a case-by-case basis, the general contractual framework between the parties, using interpretation rules
of the general Israeli contract laws. Further, the Committee has not yet determined one specific formula for calculating this remuneration,
but rather uses the criteria specified in the Patents Law. Although our employees have agreed to assign to us service invention rights
and have waived their right to receive remuneration for their service inventions, as a result of uncertainty under Israeli law with respect
to the efficacy of waivers of service invention rights, we may face claims demanding remuneration in consideration for assigned inventions.
As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current and/or former employees,
or be forced to litigate such claims, which could negatively affect our business.
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The government tax benefits that we currently are entitled to receive
require us to meet several conditions and may be terminated or reduced in the future.
Some of our operations in Israel may entitle us to certain tax
benefits under the Law for the Encouragement of Capital Investments, 5719-1959, or the Investment Law, once we begin to produce revenues.
If we do not meet the requirements for maintaining these benefits, they may be reduced or cancelled and the relevant operations would
be subject to Israeli corporate tax at the standard rate, which is set at 23% in 2024. In addition to being subject to the standard corporate
tax rate, we could be required to refund any tax benefits that we have already received, plus interest and penalties thereon. Even if
we continue to meet the relevant requirements, the tax benefits that our current “Benefited Enterprise” is entitled to may
not be continued in the future at their current levels or at all. If these tax benefits were reduced or eliminated, the amount of taxes
that we pay would likely increase, as all of our operations would consequently be subject to corporate tax at the standard rate, which
could adversely affect our results of operations. Additionally, if we increase our activities outside of Israel, for example, by way of
acquisitions, our increased activities may not be eligible for inclusion in Israeli tax benefits programs. See “Item 10. Additional
Information — Israeli Tax Considerations and Government Programs — Tax Benefits Under the 2011 Amendment” for additional
information concerning these tax benefits.”
Your rights and responsibilities
as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders
of U.S. companies.
The rights and responsibilities of the holders of our ordinary
shares are governed by our amended and restated articles of association and by Israeli law. These rights and responsibilities differ in
some material respects from the rights and responsibilities of shareholders in U.S. corporations. For example, a shareholder of an Israeli
company has a duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the
company and other shareholders, and to refrain from abusing its power in the company, including, among other things, voting at a general
meeting of shareholders on matters such as amendments to a company’s articles of association, increases in a company’s authorized
share capital, mergers and acquisitions and related party transactions requiring shareholder approval. In addition, a shareholder who
is aware that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of a director
or executive officer in the company has a duty of fairness toward the company. There is limited case law available to assist us in understanding
the nature of these duties or the implications of these provisions. These provisions may be interpreted to impose additional obligations
and liabilities on holders of our ordinary shares that are not typically imposed on shareholders of U.S. corporations.
Risks Related to Employee Matters
If we are not able to retain our
key management, or attract and retain qualified scientific, technical and business personnel, our ability to implement our business plan
may be adversely affected.
Our success largely depends on the skill, experience and effort
of our senior management. The loss of the service of any of these persons, including our Executive Chairman of the Board and interim Chief
Executive Officer, , Mr. Moshe Arkin, would likely result in a significant loss in the knowledge and experience that we possess and could
significantly delay or prevent successful product development and other business objectives. There is intense competition from numerous
pharmaceutical and biotechnology companies, universities, governmental entities and other research institutions, seeking to employ qualified
individuals in the technical fields in which we operate, and we may not be able to attract and retain the qualified personnel necessary
for the successful development and commercialization of our products.
Under applicable employment laws, we may not
be able to enforce covenants not to compete.
Our employment agreements generally include covenants not to compete.
These agreements prohibit our employees, if they cease working for us, from competing directly with us or working for our competitors
for a limited period. We may be unable to enforce these agreements under the laws of the jurisdictions in which our employees work. For
example, Israeli courts have required employers seeking to enforce covenants not to compete to demonstrate that the competitive activities
of a former employee will harm one of a limited number of material interests of the employer, such as the secrecy of a company’s
confidential commercial information or the protection of its intellectual property. If we cannot demonstrate that such an interest will
be harmed, we may be unable to prevent our competitors from benefiting from the expertise of our former employees and our competitiveness
may be diminished.
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Risks Related to Our Ordinary Shares
If we fail to maintain compliance with Nasdaq’s
continued listing requirements, our shares may be delisted from the Nasdaq Capital Market.
Our listing on Nasdaq is conditioned on our continued compliance
with Nasdaq’s continued listing requirements, including maintaining a minimum bid price of $1.00 per Ordinary Share, pursuant to
Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). On May 21, 2024, we received a notification letter from the
Nasdaq Stock Market LLC Listing Qualifications Department (“Nasdaq”) stating that we were not in compliance with the Minimum
Bid Price Rule. In accordance with the Nasdaq Listing Rules, we had a period of 180 calendar days from the date of notification, or until
November 18, 2024, to regain compliance with the Minimum Bid Price Rule.
On November 19, 2024, we received a letter from Nasdaq notifying the Company
that, while we had not regained compliance with the Minimum Bid Price Rule, Nasdaq determined that we were eligible for an additional
180 calendar day period, or until May 19, 2025 (the “Second Compliance Period”), to regain compliance. Nasdaq's determination
was based on (i) our meeting the continued listing requirement for market value of publicly held shares and all other applicable requirements
for initial listing on The Nasdaq Capital Market, with the exception of the Minimum Bid Rule and (ii) our written notice to Nasdaq of
our intention to cure the deficiency during the Second Compliance Period by effecting a reverse stock split, if necessary. In order to
be provided with a Second Compliance Period, we submitted an application to transfer the listing of our ordinary shares from the Nasdaq
Global Market to the Nasdaq Capital Market. This transfer to the Nasdaq Capital Market was approved and became effective as of November
15, 2024. On April 1, 2025, we held a special meeting of shareholders, and the proposal to grant our board of directors the discretionary
authority to effect a reverse stock split at a ratio within a range of 2 for 1 to 10 for 1 was approved. Our board then approved a reverse
split ratio of 10-for-1 on April 9, 2025. The Reverse Split will become effective at 11:59 p.m. Eastern Time on Friday, May 2, 2025.
No assurance can be given that we will be able to regain compliance
with the Minimum Bid Rule or comply with the other standards that we are required to meet in order to maintain a listing on such exchange,
and no assurance can be given that even if we regain compliance with the Minimum Bid Rule that the price of the ordinary shares will not
again be in violation of Minimum Bid Rule in the future. Our failure to meet these requirements may result in our securities being delisted
from Nasdaq.
If our ordinary shares are delisted from Nasdaq, we may seek
to list them on other markets or exchanges or the ordinary shares may trade on the pink sheets. In the event of such delisting, our shareholders’
ability to trade, or obtain quotations of the market value of, our ordinary shares would be severely limited because of lower trading
volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices for our securities.
In addition, the substantially decreased trading in the ordinary shares and decreased market liquidity of the ordinary shares as a result
of the loss of market efficiencies associated with Nasdaq and the loss of federal preemption of state securities laws, which could materially
adversely affect our ability to obtain financing on acceptable terms, if at all, and may result in the potential loss of confidence by
investors, suppliers, customers and employees and fewer business development opportunities. Additionally, the market price of the ordinary
shares may decline further and shareholders may lose some or all of their investment. There can be no assurance that the ordinary shares,
if delisted from the Nasdaq in the future, would be listed on another national or international securities exchange or on a national quotation
service, the Over-The-Counter Markets or the pink sheets.
The controlling share ownership
position of M. Arkin Dermatology will limit your ability to elect the members of our board of directors, may adversely affect our share
price and will result in our non-affiliated investors having very limited, if any, influence on corporate actions.
M. Arkin Dermatology Ltd. is currently our controlling shareholder. As of April 15,
2025, Arkin Dermatology, and its sole beneficial owner, Mr. Moshe Arkin, our Executive Chairman of the Board and interim Chief Executive
Officer, (collectively, “Arkin Dermatology”) beneficially owned approximately 65.43% of the voting power of our outstanding
ordinary shares. Therefore, Arkin Dermatology has the ability to substantially influence us and exert significant control through this
ownership position. For example, Arkin Dermatology is able to control elections of directors, amendments of our organizational documents,
and approval of any merger, amalgamation, sale of assets or other major corporate transaction. Arkin Dermatology’s interests may
not always coincide with our corporate interests or the interests of other shareholders, and it may exercise its voting and other rights
in a manner with which you may not agree or that may not be in the best interests of our other shareholders. So long as it continues to
own a significant amount of our equity, Arkin Dermatology will continue to be able to strongly influence and significantly control our
decisions.
40
We are a “controlled company”
within the meaning of Nasdaq listing standards and, as a result, will qualify for, and intend to rely on, exemptions from certain corporate
governance requirements.
As of April 15, 2025, Arkin Dermatology controls over 50%
of the combined voting power of our equity interests through the ownership of Ordinary Shares. Because of the voting power of Arkin Dermatology,
we are considered a “controlled company” for the purposes of the Nasdaq Capital Market. As such, we are exempt from certain
corporate governance requirements of Nasdaq, including (i) the requirement that a majority of the board of directors consist of independent
directors, (ii) the requirement that we have a Nominating and Corporate Governance Committee that is composed entirely of independent
directors and (iii) the requirement that we have a Compensation Committee that is composed entirely of independent directors. We currently
rely on the controlled company exemption from the requirements that a majority of our board of directors consist of independent directors,
and that we have a nominating committee composed entirely of independent directors with a written charter addressing such committee’s
purpose and responsibilities. Accordingly, you will not have the same protections afforded to shareholders of companies that are subject
to all of the corporate governance requirements of Nasdaq.
The market price of our ordinary
shares could be negatively affected by future sales of our ordinary shares.
As of April 15, 2025, there were 27,857,620 ordinary shares outstanding.
Future sales by us or our shareholders of a substantial number of our ordinary shares in the public market, or the perception that these
sales might occur, could cause the market price of our ordinary shares to decline or could impair our ability to raise capital through
a future sale of, or pay for acquisitions using, our equity securities. Of our issued and outstanding shares, all of the ordinary shares
listed for trading are freely transferable, except for any shares held by our “affiliates,” as that term is defined in Rule
144 under the Securities Act of 1933, as amended, or the Securities Act. In addition, we have filed registration statements on Form
S-8 with the Securities and Exchange Commission, or the SEC, covering all of the ordinary shares issuable under our 2014 Share Incentive
Plan, and we intend to file one or more registration statements on Form S-8 covering all of the ordinary shares issuable under our
2024 Share Incentive Plan and any other equity incentive plans that we may adopt, and such shares will be freely transferable, except
for any shares held by “affiliates,” as such term is defined in Rule 144 under the Securities Act. Upon the filing of the
registration statements, the number of ordinary shares that are potentially available for sale in the open market will increase materially,
which could make it harder for the value of our ordinary shares to appreciate unless there is a corresponding increase in demand for our
ordinary shares. This increase in available shares could result in the value of your investment in our ordinary shares decreasing.
In addition, a sale by us of additional ordinary shares or similar
securities in order to raise capital might have a similar negative impact on the share price of our ordinary shares. A decline in the
price of our ordinary shares might impede our ability to raise capital through the issuance of additional ordinary shares or other equity
securities and may cause you to lose part or all of your investment in our ordinary shares.
As of April 15, 2025, Arkin Dermatology, owned 18,227,792
Ordinary Shares, and is entitled to require that we register under the Securities Act the resale of these shares into the public markets.
All shares sold pursuant to an offering covered by such registration statement will be freely transferable. See “Item 7.B —
Related Party Transactions — Registration Rights Agreement”.
Our Outstanding Warrants are exercisable for
our ordinary shares, which will increase the number of ordinary shares eligible for future resale in the public market and result in dilution
to our shareholders.
As of April 15, 2025, we had 4,560,000 outstanding warrants to
purchase an aggregate of 4,560,000 ordinary shares. All warrants are exercisable at any time before January 27, 2028, subject to certain
limitations and exceptions. The exercise price of the warrants is $5.85 per ordinary share, which is above the current market price of
our ordinary share, which was $0.50 per share based on the closing price of the ordinary shares on Nasdaq on April 15, 2025. The
likelihood that the holders of our warrants will exercise their warrants, and the amount of any cash proceeds that we would receive upon
such exercise, is dependent upon the market price of the ordinary shares. To the extent that our outstanding warrants are exercised, additional
shares of the ordinary shares will be issued, which will result in dilution to our shareholders and increase the number of shares of the
ordinary shares eligible for resale in the public market. Sales of substantial numbers of such shares in the public market or the fact
that such outstanding warrants may be exercised could adversely affect the market price of the ordinary shares. However, there is no guarantee
that our outstanding warrants will be in the money prior to their respective expirations, and as such, they may expire worthless.
We have broad discretion as to
the use of the net proceeds from our public offerings and may not use them effectively.
We used the net proceeds from our public offering in January 2023
(and concurrent private placement) to fund the acquisition of SGT-610. The remaining proceeds
were and will be used for other research and development activities, as well as for working capital and general corporate purposes. However,
our management has broad discretion in the application of the net proceeds. Our shareholders may not agree with the manner in which our
management chooses to allocate the net proceeds from such offering. The failure by our management to apply these funds effectively could
have a material adverse effect on our business, financial condition and results of operation. Pending their use, we may invest the net
proceeds from our public offering in a manner that does not produce income.
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We do not intend to pay dividends
on our ordinary shares for at least the next several years.
We do not anticipate paying any cash dividends on our ordinary
shares for at least the next several years. We currently intend to retain all available funds and any future earnings to fund the development
and growth of our business. As a result, capital appreciation, if any, of our ordinary shares will be the investors’ sole source
of gain for at least the next several years. In addition, Israeli law limits our ability to declare and pay dividends and may subject
us to certain Israeli taxes. For more information, see “Item 8. Financial Information – A. Financial Statements and Other
Financial Information – Dividend Policy.”
As a foreign private issuer whose
shares are listed on The Nasdaq Capital Market, we are permitted to, and follow home country corporate governance practices instead of
certain Nasdaq requirements.
As a foreign private issuer whose shares are listed on The Nasdaq
Capital Market, we are permitted to follow the requirements of the Israeli Companies Law, 5759-1999, or the Companies Law, instead of
certain corporate governance requirements of Nasdaq, including with respect to the required quorum for shareholder meetings, material
changes to equity incentive plans, sending periodic reports to shareholders, and shareholder approval with respect to certain issuances
of securities. We may in the future decide to use the foreign private issuer exemption with respect to some or all of the other Nasdaq
corporate governance requirements.
Following our home country governance practices as opposed to the
requirements that would otherwise apply to a U.S. company listed on the Nasdaq Capital Market may provide less protection than is accorded
to investors of domestic issuers. See “Item 16G. Corporate Governance – Controlled Company.”
In addition, as a foreign private issuer, we are exempted from
the rules and regulations under the United States Securities Exchange Act of 1934, as amended, or the Exchange Act, related to the furnishing
and content of proxy statements (including disclosures with respect to executive compensation), and our officers, directors, and principal
shareholders are exempted from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In
addition, we are not required under the Exchange Act to file annual, quarterly and current reports and financial statements with the SEC
as frequently or as promptly as domestic companies whose securities are registered under the Exchange Act.
We may lose our foreign private
issuer status, which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us to incur significant
legal, accounting and other expenses.
We are a foreign private issuer and therefore we are not required
to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers.
In order to maintain our current status as a foreign private issuer, either (a) a majority of our ordinary shares must be either directly
or indirectly owned of record by non-residents of the United States or (b)(i) a majority of our executive officers or directors may not
be U.S. citizens or residents, (ii) more than 50 percent of our assets cannot be located in the United States and (iii) our business must
be administered principally outside the United States. If we were to lose this status, we would be required to comply with the Exchange
Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements
for foreign private issuers. We may also be required to make changes in our corporate governance practices in accordance with various
SEC and Nasdaq rules. The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting
requirements applicable to a U.S. domestic issuer may be significantly higher than the cost we would incur as a foreign private issuer.
As a result, we expect that a loss of foreign private issuer status would increase our legal and financial compliance costs and would
make some activities highly time-consuming and costly. We also expect that if we were required to comply with the rules and regulations
applicable to U.S. domestic issuers, it would make it more difficult and expensive for us to obtain director and officer liability insurance,
and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations
could also make it more difficult for us to attract and retain qualified members of our supervisory board.
We believe that we were a passive foreign
investment company for U.S. federal income tax purposes for our 2024 taxable year, which could result in materially adverse U.S. federal
income tax consequences to U.S. Holders of our ordinary shares or warrants.
A
non-U.S. entity treated as a corporation for U.S. federal income tax purposes will generally be a passive foreign investment company,
or a PFIC, for U.S. federal income tax purposes for any taxable year if either (i) at least 75% of its gross income for such year is passive
income (such as interest income); or (ii) at least 50% of the value of its assets (based on an average of the quarterly values of the
assets) during such year is attributable to cash or other assets that produce passive income or are held for the production of passive
income. Because the value of our assets for purposes of the PFIC asset test will generally be determined by reference to the market price
of our ordinary shares, based on the value and composition of our assets for our 2024 taxable year (including, in particular, the size
of our cash and other passive assets) and the changes in the market price of our ordinary shares during our 2024 taxable year, we expect
that we will be treated as a PFIC for U.S. federal income tax purposes for our 2024 taxable year.
If we are a PFIC for any taxable year during which a U.S. Holder
(as defined in “Item 10. Additional Information – U.S. Federal Income Tax Considerations”) holds our ordinary shares
or under proposed U.S. Treasury Regulations, our warrants, the U.S. Holder may be subject to adverse tax consequences, including (i) the
treatment of all or a portion of any gain on disposition as ordinary income, (ii) the application of a deferred interest charge on such
gain and the receipt of certain dividends, and (iii) compliance with certain reporting requirements.
For further discussion of the adverse U.S. federal income tax consequences
of our classification as a PFIC, see “Item 10. Additional Information — U.S. Federal Income Tax Considerations –
Passive Foreign Investment Company.”
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If a United States person is treated
as owning at least 10% of our ordinary shares, such holder may be subject to adverse U.S. federal income tax consequences.
If a United States person is treated as owning (directly, indirectly
or constructively) at least 10% of the value or voting power of our ordinary shares, such person may be treated as a “United States
shareholder” with respect to each “controlled foreign corporation” in our group (if any). If our group includes
one or more U.S. subsidiaries, under rules enacted in December of 2017, certain of our non-U.S. subsidiaries, of which there are none
at present, could be treated as controlled foreign corporations regardless of whether we are not treated as a controlled foreign corporation.
A United States shareholder of a controlled foreign corporation may be required to report annually and include in its U.S. taxable income
its pro rata share of “Subpart F income,” “global intangible low-taxed income” and investments in U.S. property
by controlled foreign corporations, regardless of whether we make any distributions. An individual that is a United States shareholder
with respect to a controlled foreign corporation generally would not be allowed certain tax deductions or foreign tax credits that would
be allowed to a United States shareholder that is a U.S. corporation. Failure to comply with these reporting obligations may subject you
to significant monetary penalties and may prevent the statute of limitations with respect to your U.S. federal income tax return for the
year for which reporting was due from starting. We cannot provide any assurances that we will assist investors in determining whether
any of our non-U.S. subsidiaries are treated as a controlled foreign corporation or whether such investor is treated as a United States
shareholder with respect to any of such controlled foreign corporations or furnish to any United States shareholders information that
may be necessary to comply with the aforementioned reporting and tax paying obligations. A United States investor should consult
its advisors regarding the potential application of these rules to an investment in the ordinary shares or warrants.
General Risk Factors
Our business and operations
may suffer in the event of information technology system failures, cyberattacks or deficiencies in our cyber-security.
We collect and maintain information in digital form that is necessary
to conduct our business, and we are increasingly dependent on information technology systems and infrastructure to operate our business.
In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual
property, proprietary business information, preclinical and clinical trial data and personal information of our employees and contractors,
or collectively, Confidential Information. It is critical that we do so in a secure manner to maintain the confidentiality and integrity
of such Confidential Information.
Despite the implementation of security measures, our information
technology systems, and those of third parties on which we rely, are vulnerable to attack, damage and interruption from computer viruses,
malware (e.g. ransomware), misconfigurations, bugs or other vulnerabilities, malicious code, natural disasters, terrorism, war,
telecommunication and electrical failures, cyberattacks, hacking, phishing attacks and other social engineering schemes, employee
theft or misuse, human error, fraud, denial or degradation of service attacks and, sophisticated nation-state and nation-state-supported
actors.
The risk of a security breach or disruption, particularly through
cyberattacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as
the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Furthermore, because
the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched
against a target, we may be unable to anticipate these techniques or implement adequate preventative measures. We may also experience
security breaches that may remain undetected for an extended period. Even if identified, we may be unable to adequately investigate or
remediate incidents or breaches due to attackers increasingly using tools and techniques that are designed to circumvent controls, to
avoid detection, and to remove or obfuscate forensic evidence. There can also be no assurance that our and our third-party service providers’,
strategic partners’, contractors’, consultants’, CROs’ and collaborators’ cybersecurity risk management
program and processes, including policies, controls or procedures, will be fully implemented, complied with or effective in protecting
our systems, networks and Confidential Information.
We and certain of our service providers are from time to time subject
to cyberattacks and security incidents. While we do not believe that we have experienced any significant system failure, accident or security
breach as a result to date, if such an event were to occur and cause interruptions in our operations or the operations of our partners
and service providers, it could result in a material disruption of our product development programs. For example, the loss of clinical
trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly
increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or
damage to our data or applications, or inappropriate access to or disclosure of Confidential Information, the costs associated with the
investigation, remediation and potential notification of the breach to counter-parties and data subjects could be material, we could be
subject to regulatory investigations and enforcement actions including fines and penalties, we could incur material legal claims and liability
(including class actions), we could suffer damage to our reputation, and the further development of our product candidates could be delayed.
Further, our insurance coverage may not be sufficient to cover the financial, legal, business or reputational losses that may result from
an interruption or breach of our systems.
43
We may incur substantial expenses as a result of the
limited nature of our disaster recovery and business continuity plan.
We have implemented a business continuity plan to prevent the collapse
of critical business processes to a large extent or to enable the resumption of critical business processes in case a natural disaster,
public health emergency, such as the global pandemic of Novel Coronavirus Disease 2019, or COVID-19, or other serious event occurs. However,
depending on the severity of the situation, it may be difficult or in certain cases impossible for us to continue our business for a significant
period of time. Our contingency plans for disaster recovery and business continuity may prove inadequate in the event of a serious disaster
or similar event and we may incur substantial costs that could have a material adverse effect on our business.
If we do not comply with laws regulating the protection
of the environment and health and human safety, our business could be adversely affected.
Our research and development and manufacturing involve the use
of hazardous materials and chemicals and related equipment. If an accident occurs, we could be held liable for resulting damages, which
could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those
governing laboratory procedures and the handling of biohazardous materials. We do not maintain insurance for environmental liability claims
that may be asserted against us. Moreover, additional foreign and local laws and regulations affecting our operations may be adopted in
the future. We may incur substantial costs to comply with such regulations and pay substantial fines or penalties if we violate any of
these laws or regulations.
With respect to environmental, safety and health laws and regulations,
we cannot accurately predict the outcome or timing of future expenditures that we may be required to make in order to comply with such
laws as they apply to our operations and facilities. We are also subject to potential liability for the remediation of contamination associated
with both present and past hazardous waste generation, handling, and disposal activities. We will be periodically subject to environmental
compliance reviews by environmental, safety, and health regulatory agencies. Environmental laws are subject to change and we may become
subject to stricter environmental standards in the future and face larger capital expenditures in order to comply with environmental laws
which could have a material adverse effect on our business.
The price of our ordinary shares may be volatile
and may fluctuate due to factors beyond our control.
The share price of publicly traded emerging biopharmaceutical and
drug discovery and development companies has been highly volatile and is likely to remain highly volatile in the future. The market price
of our ordinary shares may fluctuate significantly due to a variety of factors, including:
| • |
positive or negative results of testing and clinical trials by us, strategic partners and competitors; |
| • |
delays in entering into strategic relationships with respect to the commercialization of Twyneo and Epsolay in additional territories
or with respect to the development and/or commercialization of our product candidates or entry into strategic relationships on terms that
are not deemed to be favorable to us; |
| • |
technological innovations or commercial product introductions by us or competitors; |
| • |
changes in government regulations; |
| • |
developments concerning proprietary rights, including patents and litigation matters; |
| • |
public concern relating to the commercial value or safety of any of our products; |
| • |
financing or other corporate transactions; |
| • |
publication of research reports or comments by securities or industry analysts; |
| • |
general market conditions in the pharmaceutical industry or in the economy as a whole; or |
| • |
other events and factors, many of which are beyond our control. |
These and other market and industry factors may cause the market
price and demand for our ordinary shares to fluctuate substantially, regardless of our actual operating performance, which may limit or
prevent investors from readily selling their ordinary shares and may otherwise negatively affect the liquidity of our ordinary shares.
In addition, the stock market in general, and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations
that have often been unrelated or disproportionate to the operating performance of these companies.
44
If equity research analysts do
not publish research or reports about our business or if they issue unfavorable commentary or downgrade our ordinary shares, the price
of our ordinary shares could decline.
The trading market for our ordinary shares relies in part on the
research and reports that equity research analysts publish about us and our business. The price of our ordinary shares could decline if
one or more securities analysts downgrade our ordinary shares or if those analysts issue other unfavorable commentary or cease publishing
reports about us or our business.
We have been incurring and will
continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial
time to new compliance initiatives.
As a public company whose ordinary shares are listed in the United
States, we have been incurring and will continue to incur accounting, legal and other expenses that we did not incur as a private company,
including costs associated with our reporting requirements under the Exchange Act. We also have incurred and anticipate that we will continue
to incur costs associated with corporate governance requirements, including requirements under Section 404 and other provisions of the
Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, as well as rules implemented by the SEC and The Nasdaq Capital Market, and provisions
of Israeli corporate law applicable to public companies. These rules and regulations increase our legal and financial compliance costs,
introduce new costs such as investor relations and stock exchange listing fees, and make some activities more time-consuming and costly.
Our board and other personnel need to devote a substantial amount of time to these initiatives. Due to developments with respect to these
rules from time to time, we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. Due to
our current ‘public float’ we are eligible to take advantage of an exemption from the requirement to comply with the auditor
attestation requirements of Section 404 of the Sarbanes-Oxley Act (and the rules and regulations of the SEC thereunder). When these exemptions
cease to apply, we expect to incur additional expenses and devote increased management effort toward ensuring compliance with them.
Pursuant to Section 404 of the Sarbanes-Oxley Act and the related
rules adopted by the SEC and the Public Company Accounting Oversight Board, our management is required to report on the effectiveness
of our internal control over financial reporting. In addition, once our public float exceeds $75 million, we will lose the ability to
rely on the exemptions related thereto discussed above, and our independent registered public accounting firm may also need to attest
to the effectiveness of our internal control over financial reporting under Section 404. The process of determining whether our existing
internal controls over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses or significant
deficiencies in our existing internal controls requires the investment of substantial time and resources, including by our chief financial
officer and other members of our senior management. As a result, this process may divert internal resources and take a significant amount
of time and effort to complete. In addition, while our assessment of our internal control over financial reporting resulted in our conclusion
that as of December 31, 2024, our internal control over financial reporting was effective, we cannot predict the outcome of this
determination in future years and whether we will need to implement remedial actions in order to implement effective controls over financial
reporting. The determination and any remedial actions required could result in us incurring additional costs that we did not anticipate,
including the hiring of outside consultants. As a result, we may experience higher than anticipated operating expenses, as well as higher
independent auditor fees during and after the implementation of these changes. If we are unable to implement any of the required changes
to our internal control over financial reporting effectively or efficiently or are required to do so earlier than anticipated, it could
adversely affect our operations, financial reporting and/or results of operations and could result in an adverse opinion on internal controls
from our independent auditors.
Changes in the laws and regulations affecting public companies
will result in increased costs to us as we respond to their requirements. These laws and regulations could make it more difficult or more
costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept
reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these requirements
could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees
or as executive officers. We cannot predict or estimate the amount or timing of additional costs we may incur in order to comply with
such requirements.
45
If we fail to maintain an effective
system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As
a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading
price of our ordinary shares.
Effective internal control over financial reporting is necessary
for us to provide reliable financial reports. Any failure to implement required new or improved controls, or difficulties encountered
in their implementation could cause us to fail to meet our reporting obligations. While our assessment of our internal control over financial
reporting resulted in our conclusion that as of December 31, 2024, our internal control over financial reporting was effective, we cannot
predict the outcome of our testing or any subsequent testing by our auditor in future periods. Any testing by us conducted in connection
with Section 404, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal
controls over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to
our financial statements or identify other areas for further attention or improvement. Inferior internal controls could also cause investors
to lose confidence in our reported financial information and affect our reputation, which could have a negative effect on the trading
price of our ordinary shares.
Our management will be required to assess the effectiveness of
our internal controls and procedures and disclose changes in these controls on an annual basis. However, for so long as we have a
‘public float’ of less than $75 million on the last trading day of our second fiscal quarter, our independent registered public
accounting firm will not be required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section
404. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment
might not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur
the expense of remediation.
ITEM 4.
INFORMATION ON THE COMPANY
A.
History and Development of the Company
We were incorporated under the name “Sol-Gel Technologies
Ltd.” on October 28, 1997, and registered as a private company limited by shares under the laws of the State of Israel. Our principal
executive offices are located at 7 Golda Meir St., Weizmann Science Park, Ness Ziona, 7403650 Israel and our telephone number is
972-8-931 3433. Our website address is http://www.sol-gel.com. The information contained
therein, or that can be accessed therefrom, does not constitute a part of this annual report and is not incorporated by reference herein.
We have included our website address in this annual report solely for informational purposes.
In February 2018 we completed our initial public offering
on The Nasdaq Global Market, pursuant to which we issued 7,187,500 ordinary shares for aggregate gross proceeds of approximately $86.25
million before deducting underwriting discounts and commissions and offering expenses payable by us, including the full exercise by the
underwriters of their option to purchase additional shares. Our ordinary shares are currently traded on The Nasdaq Capital Market under
the symbol “SLGL”.
Our capital expenditures for the years ended December 31, 2022,
2023 and 2024 were approximately $171, $134 and $2 respectively. Our current capital expenditure involves equipment and leasehold improvements.
B. Business
Overview
Our Company
We are an innovative dermatology company with a successful track
record of two NDA approvals and an advanced pipeline of product candidates being developed for orphan indications. We successfully developed
pioneer topical drugs Twyneo and Epsolay, respectively approved for the treatments of acne vulgaris and inflammatory lesions of rosacea.
From 2022 until April 2025, both products were marketed in the U.S. by our U.S. commercial partner, Galderma. In April 2025, we sold our
rights related to Twyneo and Epsolay in the U.S. to Mayne, following the mutual termination by Sol-Gel and Galderma of the exclusive five-year
license agreement in the U.S. for both products. In terms of our proprietary assets in development, we are developing topical patidegib
(SGT-610) for prevention of BCC formation in Gorlin syndrome patients and topical erlotinib (SGT-210) for the treatment of Darier
Disease and other rare keratosis-related indications.
46
Products and Pipeline
We are a dermatology company leveraging innovative approaches
to develop pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel,
2%) for prevention of BCC formation in Gorlin syndrome patients, and a phase 1 clinical trial of SGT-210 for Darier Disease and with two
approved large-category dermatology products, Twyneo and Epsolay.
Our current product candidate pipeline includes SGT-610 (Patidegib
Gel 2%), a new chemical entity hedgehog signaling pathway blocker, for the chronic use and prevention of new BCC in Gorlin syndrome patients,
and the topical drug candidate SGT-210 for the treatment of Darier Disease and other rare keratosis-related indications such as PC, PPK
and Olmsted.
Our FDA-approved product, Twyneo, is a novel, once-daily, non-antibiotic
topical cream containing a fixed-dose combination of encapsulated benzoyl peroxide, or BPO, and encapsulated tretinoin, developed for
the treatment of acne vulgaris, the most common type of acne. Our FDA-approved product, Epsolay, is a novel, once-daily topical cream
containing encapsulated BPO that we have developed for the treatment of inflammatory lesions of rosacea.
In April 2025, we sold our rights related to Twyneo and Epsolay
in the U.S. to Mayne, following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S.
for both products, which were entered into in June 2021. In June 2023, we entered into two exclusive license agreements with Searchlight
pursuant to which Searchlight has the exclusive right, and is responsible for, all regulatory and commercial activities for Twyneo and
Epsolay in Canada, over a fifteen-year term that is renewable for subsequent five-year periods. In May 2024, we entered into an
asset purchase agreement with Beimei, pursuant to which Beimei purchased and licensed the rights to commercialize and manufacture Twyneo
in China, Hong Kong, Macau, Taiwan and Israel. Lastly, during 2024, we also entered into commercialization agreements for commercialization
of Twyneo and Epsolay in most European countries, South Africa and South Korea.
The following chart represents our current approved products and
candidate pipeline:
47
We are developing the new chemical entity SGT-610 (patidegib Gel
2%), a hedgehog signaling pathway blocker, for the chronic use and prevention of new BCC in Gorlin syndrome patients. Gorlin syndrome
is a rare disease with no therapies approved by the FDA or the EC for this disease. SGT-610 is aimed to prevent new BCCs in adults with
Gorlin syndrome without systemic adverse events. We believe it has the potential to be the first drug approved for such indication. SGT-610
has been granted orphan drug designation by the FDA and the EC as well as Breakthrough Therapy designation by the FDA. If approved by
the FDA, SGT-610 has the potential to generate, at peak, annual net sales in excess of $300 million (based in part on independent sources
and also based on our good faith estimates). Although we believe such data and estimate to be reliable, it involves a number of assumptions
and limitations, including without limitations the number of patients, the penetration level of the treatment, and the expected treatment
annual price.
On November 30, 2023, we announced that we have begun screening
patients for our Phase 3 study. In a previous Phase 3 clinical trial of patidegib sponsored by PellePharm the SGT-610 arm was found to
be as tolerable as the non-therapeutic vehicle substance, and the significant adverse events commonly seen with oral hedgehog inhibitors
were not observed. Our Phase 3 clinical trial includes essential modifications to PellePharm’s previous Phase 3 study. We have refined
screening criteria in order to enroll subjects with more severe disease at baseline based on a higher baseline number of facial BCC lesions.
This refinement may help to better demonstrate the preventive effect of our product candidate. We are also pre-screening patients for
a specific genetic mutation associated with Gorlin syndrome that is considered relevant for HH inhibitors. In an effort to increase patient
study compliance we reduced the number of visits over the 12 months of treatment during the trial. According to the Phase 3 trial design
approximately 140 subjects will be enrolled at approximately 40 experienced clinical centers in North America, United Kingdom and Europe. To
date, we have signed agreements with 43 centers in multiple countries, including the U.S., Spain, the Netherlands, Germany, Italy, France
and the UK, all of these centers have been activated, and 80% of the trial subjects have been recruited. We currently expect results of
our Phase 3 study in the fourth quarter of 2026.
The rights to SGT-610 were purchased on January 30, 2023, pursuant
to an asset purchase agreement with PellePharm, dated January 23, 2023.
Under the terms of the agreement upon closing of the transaction,
we paid an upfront payment of $4 million to PellePharm, and the remaining principal amount outstanding of $0.7 million has not been transferred
as of the issuance date of this report. We are also required to pay:
| • |
up to $6 million in total development and NDA acceptance milestone payments; |
| • |
up to $64 million in commercial milestone payments, which amount increases to $89 million when sales exceed $500 million; and
|
| • |
single digit royalties, which increase to double digit royalties when sales exceed $500 million. |
SGT-210 (erlotinib) is a topical drug candidate for the treatment
of rare keratosis-related indications. Erlotinib is a tyrosine kinase receptor inhibitor which acts on the epidermal growth factor receptor,
a protein expressed on the surface of cells, whose job is to help cells grow and divide. Published clinical research has shown that orally
administered erlotinib improved the quality of life of pachyonychia congenita patients but was associated with significant adverse events,
while topically applied erlotinib, 0.2%, failed to display significant improvement1. Sol-Gel’s scientists have developed a topical
product with a significantly higher concentration of erlotinib than that which was reported to be inefficient. SGT-210 is expected
to treat rare keratosis-related indications with limited incidence of the adverse events that can result from oral administration
erlotinib. Our initial Phase-1 study of SGT-210 has been completed, with results supporting further development of this product candidate.
We initiated a Phase 1 clinical trial for Darier Disease in March 2024. If we successfully complete this proof-of-concept study and the
required pre-clinical studies, we anticipate submitting an investigational new drug application (IND) to FDA for a Phase 2 trial
in the second quarter of 2025. In addition, we have been using SGT-210 in a compassionate use treatment for a pediatric patient suffering
from an ultra-rare disease with preliminary highly encouraging response.
Twyneo, is a once-daily, non-antibiotic topical cream, containing
a fixed-dose combination of encapsulated benzoyl peroxide, or E-BPO, and encapsulated tretinoin for the treatment of acne vulgaris. Acne
vulgaris is one of the three most prevalent skin diseases in the world and is the most commonly treated skin disease in the United States.
According to the American Academy of Dermatology, acne vulgaris affects approximately 40 to 50 million people in the United States, of
which approximately 10% are treated with prescription medications. Tretinoin and benzoyl peroxide, the two active components in Twyneo,
are both widely-used therapies for the treatment of acne vulgaris that historically have not been conveniently co-administered due to
stability concerns. Twyneo was approved for marketing by the FDA in July 2021 in the United States and was licensed in the United
States exclusively to Galderma from June 2021 until April 2025 when we sold our rights related to Twyneo and Epsolay in the U.S. to Mayne,
and in Canada exclusively to Searchlight in June 2023. The rights to commercialize and manufacture Twyneo in China, Hong Kong, Macau,
Taiwan and Israel were purchased and in licensed by Beimei in May 2024. We also entered into commercialization agreements for commercialization
of Twyneo in most European countries, South Africa and South Korea during 2024.
48
Epsolay, is a once-daily topical cream containing 5% encapsulated
benzoyl peroxide, that we have developed for the treatment of inflammatory lesions of rosacea in adults. Rosacea is a chronic skin disease
characterized by facial redness, inflammatory lesions, burning and stinging. According to the U.S. National Rosacea Society, approximately
16 million people in the United States are affected by rosacea. Subtype II rosacea is characterized by small, dome-shaped erythematous
papules, tiny surmounting pustules on the central aspects of the face, solid facial erythema and edema, and thickening/overgrowth of skin.
Subtype II rosacea resembles acne, except that comedowns are absent, and patients may report associated burning and stinging sensations.
Current topical therapies for subtype II rosacea are limited due to tolerability concerns. For example, BPO, a common therapy for acne,
is not used for the treatment of subtype II rosacea due to side effects. As encapsulated BPO, Epsolay is designed to redefine the standard
of care for the treatment of subtype II rosacea. Epsolay, is the first product containing BPO that is marketed for the treatment
of subtype II rosacea. Epsolay was approved for marketing by the FDA in April 2022 and was licensed in the United States exclusively to
Galderma in June 2021 and in Canada exclusively to Searchlight in June 2023. We also entered into commercialization agreements for commercialization
of Epsolay in most European countries, South Africa and South Korea during 2024.
In April 2025, we sold our rights related to Twyneo and Epsolay in the U.S. to Mayne,
following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. for both products, which
were entered into in June 2021.
In May 2024, we entered into an asset purchase agreement with
Beimei, pursuant to which Beimei purchased and licensed the rights to commercialize and manufacture Twyneo in China, Hong Kong, Macau,
Taiwan and Israel. We expect to receive, subject to applicable government approvals, a total consideration of up to $15 million, out of
which $10 million will be paid as upfront and regulatory milestones, and the remaining $5 million will be paid as royalties on net sales.
In June 2023, we entered into exclusive license agreements with
Searchlight, a private Canadian specialty pharmaceutical company, pursuant to which Searchlight has the exclusive right, and is responsible
for all commercial activities for Twyneo and Epsolay in Canada, over a fifteen-year term that is renewable for subsequent five-year periods.
Searchlight will be responsible for obtaining and maintaining ay regulatory approvals required to market and sell the drugs in Canada
with support from us. In consideration for the grant of such rights, we will receive up to $11 million in potential upfront payments and
regulatory and sales milestones for both drugs, combined. In addition, we will be entitled to royalty percentages of all Canadian net
sales ranging from low-double-digits to high teens.
Our Products
SGT-610 for Gorlin Syndrome
We are developing SGT-610 for chronic use in Gorlin syndrome
patients to reduce the significant tumor burden of persistently developing basal cell carcinomas (BCCs) with a minimum systemic tolerability
side effects seen with and approved oral formulations of Hedgehog (HH) pathway inhibitors. SGT-610 has been granted orphan drug designation
by the FDA and the EC, as well as Breakthrough Therapy designation by the FDA. Both FDA and the European Medicines Agency (EMA) have agreed
that a single pivotal Phase 3 study may be sufficient for the approval of this investigational drug. If approved by the FDA, SGT-610 has
the market potential to generate, at peak, annual sales between $400 million and $500 million (based on good faith estimates derived from
our knowledge and based in part on independent sources). Although we believe such data and estimate it to be reliable, it involves a number
of assumptions and limitations, including without limitation the number of patients, the penetration level of the treatment, and the expected
treatment annual price.
On November 30, 2023, we announced that we began screening patients
for our Phase 3 study. In PellePharm’s study the SGT-610 arm was found to be as tolerable as the vehicle and the significant
adverse events commonly seen with oral hedgehog inhibitors were rarely observed.
Our clinical study includes essential modifications to the previous
Phase 3 study sponsored by PellePharm. We refined screening criteria in order to enroll subjects with a more severe disease at baseline
reflected in a higher baseline number of facial BCC lesions. This refinement may help to better demonstrate the preventive effect of our
product candidate. We are also screening patients for a specific genetic mutation associated with Gorlin syndrome that is considered relevant
for HH signaling pathway. In an effort to increase patient study compliance we reduced the number of on-site visits over the 12 months
of treatment during the trial. According to our Phase 3 trial design approximately 140 subjects (with 100 subjects required to complete
the study) will be enrolled at approximately 40 experienced clinical centers in North America, United Kingdom and Europe. To
date, we have signed agreements with 43 centers in multiple countries, including the U.S., Spain, The Netherlands, Germany, Italy, France
and the UK, all of which enters have been activated and 80% of the trial subjects have been recruited. We currently expect results of
our Phase 3 study in the fourth quarter of 2026.
49
Basal Cell Carcinomas
Basal cell carcinomas, BCCs are the most common of human cancers,
occurring in an estimated 2 to 3 million Americans each year. The overwhelming majority of BCCs occur at a low tempo with a strong predilection
for sun exposed skin sites in persons of Northern European descent who have had excessive sun exposure. They are most commonly seen starting
in the fourth decade of life. Some patients develop BCCs at a higher tempo and often at a younger age. They are referred to as having
High Frequency BCC (HF-BCC). These include patients with rare genetic BCC syndromes that have been well characterized along a spectrum
of severity and frequency of BCC formation. Gorlin syndrome is the most common of these rare conditions. More recently, a subset of patients
with HF-BCC has been identified who develop multiple BCCs throughout life at an unusually high frequency, but who do not qualify for a
diagnosis of Gorlin syndrome. This patient population is referred to as non Gorlin high frequency basal cell carcinoma.
Gorlin Syndrome
Gorlin syndrome is a rare disease with no therapies currently approved
by the FDA or the EC for this disease. Gorlin syndrome affects approximately 1 in 31,000 people and is an autosomal dominant genetic
disorder, mostly caused by inheritance of one defective copy of the tumor suppressor gene PTCH1. The PTCH1 gene blocks the SMO gene, turning
off the hedgehog signaling pathway when it is not needed. However, mutations in PTCH1 may cause loss of PTCH1 function, release
of SMO, and may allow BCC tumor cells to divide uncontrollably. Gorlin syndrome is also called nevoid BCC syndrome because approximately
90% of individuals with this syndrome develop multiple BCCs, ranging from a few to many thousands of lesions during a patient’s
lifetime. Gorlin syndrome patients are also susceptible to many abnormalities, including, most frequently, palmar and plantar pits and
jaw cysts, and, most devastatingly, medulloblastomas. We estimate that there are approximately 17,000 Gorlin syndrome patients with
multiple BCCs worldwide. Painful surgical excision is currently the treatment of choice for BCCs. However, as multiple BCCs continue
to evolve, repeated surgical intervention becomes practically impossible, which makes the prevention of the development of new BCCs a
critical treatment consideration. Patidegib, the active substance in SGT-610, is designed to block the SMO signal, thus allowing
cells to function normally and reduce production of new tumors.
Current Treatment Options for Gorlin Syndrome
In general, patients with Gorlin syndrome have their BCCs treated
as they become problematic, such as when the BCCs present a risk of invasion of vital structures on the face such as eyes, nose, or ears,
or become large enough off the face that they are uncomfortable, bleed, etc. Patients with Gorlin syndrome are typically never free of
BCCs. Although currently available oral drug treatments can produce partial or complete clinical clearing, once the drug is stopped the
BCCs recur.
Topical Treatment:
Several topically-applied drugs are used in the treatment of BCCs, in particular imiquimod and 5-fluorouracil. Based on clinical trials
performed both of these topical products can cure approximately 80% of the superficial subtype of BCCs, most of which generally occur
off the face. However, clinical trials demonstrate that these treatments generally are not useful against nodular BCCs, which are the
more prevalent subtype, especially on the face. In addition, clinical trials show that both typically cause significant inflammation at
sites of application, which render them inadequate for the long-term management of a chronic condition.
Retinoid Treatment:
Oral retinoid treatment of patients with Gorlin syndrome can reduce the rate of development of BCCs, but based on clinical trials it does
so only at a dose that usually produces intolerable side effects.
Oral HH Inhibitors:
With identification of uncontrolled HH signaling as the driving molecular abnormality in all BCCs, several anti-HH drugs have been developed
for oral treatment of BCCs, and two of these - vismodegib and sonidegib - have been approved for systemic treatment of advanced
BCCs defined as BCCs whose surgical excision likely would produce unsatisfactory results (i.e. “locally advanced”) or those
which have become metastatic. Clinical trials demonstrate that approximately 50% of such advanced BCCs fail to respond initially, frequently
due to mutations in the SMOOTHENED (SMO) gene, which encodes the protein to which these HH inhibitor drugs bind. Clinical trials further
evidence that of those that do respond, a significant proportion develop secondary resistance, often due to mutations in the drug binding
pocket of the SMO protein.
Vismodegib has been studied for efficacy against BCCs in patients
with Gorlin syndrome and has demonstrated a combined result of shrinkage of existing BCCs and prevention of the development of new BCCs
as long as patients continue to take vismodegib. However, clinical trials show that most patients discontinue vismodegib because of class-specific
side effects that affect their quality of life. Clinical trials demonstrate that oral HH inhibitors have a poor long-term safety and tolerability
record for a chronic condition due to unacceptable side effects such as loss of hair, sense of taste, and weight; fatigue; and intense
muscle cramps. The severity of the adverse events (AEs) associated with vismodegib is illustrated by the fact that 54% of patients with
Gorlin syndrome in an oral vismodegib clinical trial discontinued treatment because of adverse effects despite clear efficacy against
their BCCs.
Surgical Treatment of
BCCs: Given the lack of alternative treatment options, patients who develop a high
rate of BCCs often need surgery for their chronic tumors. However, studies show that surgery has significant morbidity (e.g., scarring,
disfigurement, functional loss of eyelid, nose, ear) and multiple surgeries may lead to psychological distress of the patient. The number
of surgically eligible BCCs and specifically, the chronic surgical intervention, constitutes a significant burden of disease in patients
with Gorlin syndrome.
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SGT-210 for Darier Disease and other rare keratosis-related indications
We are developing SGT-210
for the treatment of Darier Disease and other rare keratosis-related indications, such as PC, PPK, Olmsted, etc. a group of skin conditions
characterized by impaired kertanization of the skin. SGT-210 is designed to be used alone or in combination for the treatment of hyperproliferation
and keratinization disorders. On January 2, 2020, we announced the initiation of a Phase 1 clinical study of SGT-210 in patients
with palmoplantar keratoderma. The Phase 1 concept study SGT-84-01 is a single-center, single-blinded, vehicle-controlled study designed
to evaluate the bioavailability, safety and tolerability of SGT-210 as well as inform on potential efficacy. During the third quarter
of 2021, we reported that the study with respect to six (6) palmoplantar keratoderma (PPK) patients has been completed and indicated modest
improvement and a favorable safety results. Two elevated concentrations of topical erlotinib were investigated in MUSE –PK
Phase I study on healthy volunteers initiated in December 2022. The study was finalized in the second quarter of 2023, where topical
erlotinib was generally safe and well tolerated and minimal absorbance regardless of its concretion was observed. We believe these results
support further development of this product candidate. We initiated a Phase 1 clinical trial for Darier Disease in March 2024.
Darier Disease (DD), also known as Darier-White disease or Keratosis
follicularis, is an autosomal dominant genodermatosis caused by a mutation in the ATP2A2 gene, encodes the SERCA2 protein, a calcium pump
located in the sarcoplasmic/endoplasmic reticulum. The disease manifests as greasy, hyperkeratotic papules in seborrheic regions, along
with nail abnormalities and mucous membrane changes, and infections. The estimated worldwide prevalence ranges from 1 in 30,000 to 1 in
100,000 individuals, typically beginning in puberty and exacerbated throughout the lifespan, usually with external exposures, such as
sunlight. Current treatments include topical emollients and retinoids for mild cases, and oral retinoids and antibiotics for moderate
to severe cases.
Twyneo for Acne Vulgaris
Using our proprietary, silica-based microencapsulation technology
platform, we developed Twyneo to become a preferred treatment for acne vulgaris by dermatologists and their patients. Twyneo was approved
for marketing by the FDA in July 2021.
Twyneo is a novel, once-daily, non-antibiotic topical cream containing
a fixed-dose combination of encapsulated benzoyl peroxide and encapsulated tretinoin that we developed for the treatment of acne vulgaris.
Studies have shown that benzoyl peroxide and tretinoin are effective in treating acne as monotherapies; moreover, according to an
article in the American Academy of Dermatology (2009), dermatologists recommend combining the two monotherapies as a first-line approach
for acne, but a drug-drug interaction that causes the degradation of tretinoin has previously prohibited the development of a combination
therapy. By encapsulating the two agents separately through the use of our technology platform, Twyneo is designed to be a fixed-dose
combination that otherwise would not be stable. Similar to other combination drug products, such as clindamycin and benzoyl peroxide,
Twyneo is required to be kept refrigerated throughout the supply chain and then stored in ambient conditions upon its distribution to
patients. Pre-clinical data suggests that Twyneo may be more tolerable than generic tretinoin gel 0.1% and Epiduo, a branded fixed-dose
combination of benzoyl peroxide and adapalene, without a corresponding loss in efficacy. In addition, Epiduo and its successor Epiduo
Forte contain adapalene as opposed to tretinoin, which is widely considered to be more effective than adapalene, but generally causes
greater irritation. In the U.S. Twyneo competes directly with Winlevi, Aklief, Epiduo, Epiduo Forte and Cabtreo. On December 30, 2019,
we announced top-line results from two pivotal Phase 3 clinical trials evaluating Twyneo for the treatment of acne vulgaris. Twyneo
met all co-primary endpoints in both Phase 3 trials. The Phase 3 program enrolled an aggregate of 858 patients aged nine and older
in two multicenter, randomized, double-blind, parallel group, vehicle-controlled trials at 63 sites across the United States. Twyneo demonstrated
statistically significant improvement in each of the co-primary endpoints of (1) the proportion of patients who succeeded in achieving
at least a two grade reduction from baseline and Clear (grade 0) or Almost Clear (grade 1) at Week 12 on a 5-point Investigator Global
Assessment (IGA) scale, (2) an absolute change from baseline in inflammatory lesion count at Week 12, and (3) and an absolute change from
baseline in non-inflammatory lesion count at Week 12. In addition, Twyneo was found to be well-tolerated.
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Acne Market Opportunity
Acne vulgaris is a disease characterized by areas of scaly red skin, non-inflammatory
blackheads and whiteheads, inflammatory lesions, papules and pustules and occasionally boils and scarring that occur on the face, neck,
chest, back, shoulders and upper arms. The development of acne lesions is caused by genetic and environmental factors that arise from
the interplay of the following pathogenic factors:
| • |
blockage of hair follicles through abnormal keratinization in the follicle, which narrows pores; |
| • |
increase in oils, or sebum production, secreted by the sebaceous gland; |
| • |
overgrowth of naturally occurring bacteria caused by the colonization by the anaerobic lipohilic bacterium Propionibacterium acnes,
or P. acnes; |
| • |
inflammatory response due to relapse of pro-inflammatory mediators into the skin. |
Due to the frequency of recurrence and relapse, acne vulgaris is
characterized as a chronic inflammatory disease, which may require treatment over a prolonged period of time. Acne vulgaris is one of
the three most prevalent skin diseases in the world and is the most commonly treated skin disease in the United States. According to the
American Academy of Dermatology, acne affects approximately 40 to 50 million people in the United States and approximately 85% of people
between the ages of 12 and 24 experience some form of acne. Acne vulgaris patients suffer from the appearance of lesions on areas of the
body with a large concentration of oil glands, such as the face, chest, neck and back. These lesions can be inflamed (papules, pustules,
nodules) or non-inflamed (comedones). Early effective treatment is recommended to lessen the overall long-term impact. For most people,
acne diminishes over time and tends to disappear, or at least to decrease, by the age of 25. There is, however, no way to predict how
long it will take for symptoms to disappear entirely, and some individuals continue to suffer from acne well into adulthood.
Current Treatment Landscape for Acne
The treatment options for acne depend on the severity of the disease and consist of
topical and oral drugs:
| • |
Mild acne: characterized by few papules or pustules (both comedonal and inflammatory);
treated with an over-the-counter product or topical prescription therapies. |
| • |
Moderate acne: characterized by multiple papules and pustules with moderate inflammation and
seborrhea (scaly red skin); treated with a combination of oral antibiotics and topical therapies. |
| • |
Severe acne: characterized
by substantial papulopustular disease, many nodules and/or cysts and significant inflammation and seborrhea; treated with oral and topical
combination therapies and photodynamic therapy as a third-line treatment. Topical therapies dominate the acne market as physicians and
patients often prefer therapies that act locally on the skin, while minimizing side effects. For more pronounced symptoms, patients are
typically treated with a combination of topical and oral therapies. |
The acne prescription treatment landscape is comprised of four classes of topical
products and two classes of oral products:
| • |
Topical over-the-counter monotherapies such as adapalene 0.1%, benzoyl peroxide and salicylic
acid, in different concentrations, are the most commonly used therapies. These are generally tolerable first-line treatments for mild
acne, but less efficacious than prescription therapies. |
| • |
Topical prescription antibiotic monotherapies such as clindamycin and erythromycin that are
most commonly used as topical therapies in cases of mild-to-moderate acne. |
| • |
Topical prescription retinoid monotherapies such as tretinoin, adapalene 0.3% and tazarotene.
Physicians view retinoids as moderately efficacious, but they have high rates of skin irritation. |
| • |
Topical prescription combination products such as combinations of BPO/adapalene, BPO/clindamycin,
BPO/adapalene/clindamycin, BPO/erythromycin and clindamycin/tretinoin. These target multiple components that contribute to the development
of acne, though topical side effects are common. |
| • |
Oral prescription antibiotics such as doxycycline and minocycline. These are typically used
as step-up treatments for more severe cases of acne, with risk of systemic side effects. |
| • |
Oral prescription isotretinoin, which is primarily used for severe cystic acne and acne that
has not responded to other treatments. The use of oral prescription isotretinoin is tightly controlled due to tolerability issues.
|
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Epsolay for Subtype II Rosacea
Epsolay Overview
Epsolay is a once-daily investigational topical cream containing
5% encapsulated benzoyl peroxide that we have developed for the treatment of papulopustular (subtype II) rosacea. Subtype II rosacea is
characterized by small, dome-shaped erythematous papules, tiny surmounting pustules on the central aspects of the face, solid facial erythema
and edema, and thickening/overgrowth of skin. Subtype II rosacea resembles acne, except that comedones are absent, and patients may report
associated burning and stinging sensations. In the U.S. Epsolay competes directly with Soolantra. We utilized the FDA’s 505(b)(2)
regulatory pathway in seeking approval of Epsolay in the United States. On July 8, 2019,
we announced positive top-line results from our Phase 3 program evaluating Epsolay. The program enrolled 733 patients
aged 18 and older in two identical, double-blind, vehicle-controlled Phase 3 clinical trials at 54 sites across the United States. Epsolay
demonstrated statistically significant improvement in both co-primary endpoints of (1) the number of patients achieving “clear”
or “almost clear” in the Investigator Global Assessment (IGA) relative to baseline at week 12 and (2) absolute mean reduction
from baseline in inflammatory lesion count at week 12. In an additional analysis, Epsolay demonstrated rapid efficacy, achieving statistically
significant improvements on both co-primary endpoints compared with vehicle as early as Week 2. In addition, Epsolay was found to be well-
tolerated. On February 12, 2020, we announced positive topline results from our open-label, long-term safety study, evaluating Epsolay
for a treatment duration up to 52 weeks. Epsolay was approved for marketing by the FDA in April 2022.
Current Treatment Landscape for Subtype II Rosacea
As there is no cure for rosacea, treatment is largely focused on
managing the disease. We believe that a significant market opportunity exists for a subtype II rosacea treatment option that can provide
both efficacy and higher tolerability than existing treatments. There are currently five approved drugs for the treatment of subtype II
rosacea: Soolantra, Metrogel, Oracea, Zilixi and generic metronidazole. In certain cases, dermatologists often prescribe oral antibiotics
either as monotherapies or in conjunction with approved medications.
Our Solution for Subtype II Rosacea — Epsolay
Benzoyl peroxide is approved by the FDA for the treatment of
acne and is widely considered to be safe and effective. Previously, there was no benzoyl peroxide product approved for the treatment
of rosacea as a result of potential tolerability issues, despite clinical studies showing that treatment with benzoyl peroxide could be
efficacious. According to a published study, benzoyl peroxide was found to be an effective treatment for rosacea but caused irritation.
Using our proprietary, silica-based microencapsulation technology platform, we believe our Epsolay treatment of papulopustular (subtype
II) rosacea can improve on current subtype II rosacea treatments in the following ways:
| • |
Epsolay creates a silica-based barrier between benzoyl peroxide crystals and the skin and, as a result, can reduce irritation typically
associated with topical application of benzoyl peroxide, increasing the potential for more tolerable application to rosacea-affected skin.
|
| • |
Epsolay’s release of the drug can reduce irritation while maintaining efficacy. |
Epsolay is an innovative topical cream, and the first FDA approved
product containing benzoyl peroxide for the treatment of subtype II rosacea.
Generic Drug Product Candidates
We previously had collaboration arrangements with Perrigo to develop
a portfolio of 11 generic topical dermatological product candidates. In November 2021, we announced that we had signed an agreement with
Padagis, pursuant to which we sold our rights related to 10 generic collaborative agreements between the parties. Under the terms of this
agreement with Padagis, effective as of we received $21.5 million over 24 months, in lieu of our share in the ten generic programs, two
of which were approved by the FDA, and eight of which are unapproved. Pursuant to the agreement, effective as of November 1, 2021,
we ceased paying any outstanding and future operational costs related to these 10 collaborative agreements.
Following the agreement, we had one remaining active collaboration
agreement with Padagis for the development, manufacturing and commercialization of a generic drug product to Zoryve® Cream (roflumilast
cream 0.3%). On August 15, 2024, we signed a new agreement with Padagis, which replaced the parties’ prior collaboration agreement
for the development and commercialization of such generic drug product. Under this new agreement, we are to unconditionally
receive eight quarterly payments which will be paid over 24 months and low single digit royalties from gross profits from sales of
roflumilast cream for a period of five years, in lieu of our share in future gross profits from such sales. In addition, Sol-Gel ceased
paying any outstanding and future costs related to this prior collaboration agreement. The amount to be received from Padagis, together
with the elimination of future expected expenses related to this asset, is expected to enhance our cash position by approximately $6 million.
53
Our Proprietary Silica-Based Microencapsulation Technology Platform
Encapsulation of a drug substance can be made using a variety
of techniques, such as solvent evaporation, coacervation, and interfacial polymerization. Most encapsulations involve organic polymers,
such as poly-methyl methacrylate, chitosan and cellulose. The resultant encapsulated drug substance can be an aqueous dispersion of varying
payload and volume fraction or a dried powder. Control over the encapsulation process when organic polymers are used is challenging and
is mainly limited to shell thickness. Other properties of the organic polymer encapsulating material are hard to control.
In contrast, we use proprietary ‘sol-gel’ processes
to shape silica on site to form microcapsule shells of almost any size and release profile. Sol-gel is a chemical process whereby amorphous
silica, or other metal oxides, are made by forming interconnections among colloidal particles (the “sol”) under increasing
viscosity until a rigid silica shell (the “gel”) is formed. The drug substance that is added during the sol-gel reaction is
encapsulated, using a patented technique, by which a core-shell structure is formed. The drug substance is in the core and the silica
is the capsule shell. At the end of the process, the microcapsules are in the shape of small beads ranging from 1 – 50
micron in size. This process results in an aqueous suspension in which the drug substances are entrapped in silica particles.
Intellectual Property
Our intellectual property and proprietary technology are directed
to the development, manufacture and sale of our products. We seek to protect our intellectual property, core technologies and other know-how,
through a combination of patents, trademarks, trade secrets, non-disclosure and confidentiality agreements, assignments of invention and
other contractual arrangements with our employees, consultants, partners, suppliers, customers and others.
We will be able to protect our technology from unauthorized use
by third parties only to the extent it is covered by valid and enforceable patents or is effectively maintained as trade secrets. Patents
and other proprietary rights are an essential element of our business. If any of the below described applications are not approved, or
any of the below described patents are invalidated, deemed unenforceable or otherwise successfully challenged, such loss would have a
material effect on the commercialization of Twyneo, Epsolay, our product candidates (once approved), if approved, and our future prospects.
Our patent portfolio that is directed to Twyneo, Epsolay
and our product candidates includes 70 patents and patent applications and claims processes for manufacture (including silica microencapsulation
platform and other technologies), formulations, composition of matter, and methods of use. Of these 70 patents and patent applications,
45 are granted patents (25 in the United States and 20 in other countries) and 4 patent applications are allowed (3 in the United States
and 1 in other counties) 21 are pending applications (9 in the United States and 12 in other countries).
For
SGT-610, we have one published international application that refers to a method of treatment with SGT-610, one international
application that refers to a method of treatment with SGT-610 for a period of more than 12 months; and one pending application in
the United States that refers to a process for preparation of SGT-610; and we purchased from PellePharm 3 granted patents in the US (with
a term until 2036), 2 granted patents in South Africa, and granted patents in Israel, Japan, Mexico, Canada, Chile, Brazil, and Australia
and pending applications in Europe and Hong Kong. We also licensed from Royalty Security LLC (as part of the asset purchase from
PellePharm) 22 granted patents in the US (with terms 2027-2031), 1 granted patent in Canada, 36 granted patents in Europe (Norway
and EPO members such as France, Germany, Ireland, Switzerland, United Kingdom, Spain, Italy, etc.) 37 granted patents in the rest of the
world (such as Argentina, Australia, Brazil, Chile, China, Hong-Kong, Israel, India, Japan, Korea, Mexico, New Zealand, Philippines, Russia,
Singapore, Thailand, Taiwan, Ukraine, South Africa).
For SGT-610, we have one trademark ,'Saquelta', registered in Israel,
Albania, Armenia, Australia, Azerbaijan, Belarus, Bhutan, Bosnia & Herzegovina, Botswana, Brazil ,China, Colombia, Denmark, Dominican
Republic, Egypt, Georgia, Iceland, Kazakhstan, Kenya, Kyrgyzstan, Liechtenstein, Madagascar, Moldova, Monaco, Montenegro, Morocco, Mozambique,
Namibia, New Zealand, North Macedonia, Norway, Russian Federation, San Marino, Serbia, Singapore, Switzerland, Tajikistan, Turkey, Turkmenistan,
Ukraine, USA, Uzbekistan, Vietnam, Zambia, Curacao, European Union, United Kingdom, Peru, Andorra, Hong Kong, Ecuador, and Argentina.
Saquelta was also filed for registration in India, Jamaica, Taiwan, Thailand, United Arab Emirates, Mexico, Panama, Sri Lanka and Aruba.
We also purchased the rights to the trademark ‘Squelta’ in Barbados, Canada, Costa Rica, Guatemala, OAPI, Paraguay, South
Africa, Venezuela, Chile, El Salvador, Honduras, Japan, Nicaragua, South Korea, and Uruguay and are yet to record this trademark in our
name in such countries.
54
For Twyneo, we have obtained patent protection for the composition
of matter in the United States, Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom) and Mexico
(with a term until 2028). There are four patent families protecting the process for the encapsulation of the active agents of our Twyneo
product (one patent family has patents granted in India, Mexico, and Europe (validated in France, Germany, Ireland, Italy, Spain,
Switzerland and the United Kingdom) (with a term until 2028), one patent granted in the United States, and one application pending in
the United States; the second patent family has patents granted in Mexico and the United States (with a term until 2029); the third patent
family has patents granted in Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom),
India, Mexico and the United States (with a term until 2030); and the fourth patent family has patents granted in India, Mexico
and the United States. We own patents granted for the formulation of our Twyneo product in the United States, Mexico and Europe (validated
in France, Germany, Ireland, Italy, Spain, Switzerland, United Kingdom) (with a term until 2032). We have allowed patents in Europe and
in the United States (with a term until 2038). We have patents granted in India and Mexico (with a term until 2038), pending patent applications
in the United States (with a term until 2041), and Europe for the composition of our Twyneo product, patents granted in the United States
(with a term until 2041) and Mexico (with a term until 2038) and patent applications pending in Europe and in the United States for
the method of treatment of Twyneo (with a term until 2038).
We have five trademarks registered for our Twyneo product in Israel,
Europe, the United States, Canada, Mexico, Brazil and Australia. Twyneo was also filed for registration in India, Norway, Iceland,
Serbia, Bosnia & Herzegovina, Montenegro, Albania, North Macedonia, South Korea, Kosovo, and South Africa.
For Epsolay, we have obtained patents in China, Europe (validated
in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom), Mexico (with a term until 2032) ,United States (with a
term until 2041), and an allowed patent (with a term until 2040) covering the composition for topical treatment of rosacea. There
are two patent families directed to the process for encapsulation of the active agents of Epsolay (one patent family has granted patents
in Mexico, Europe (validated in France, Germany, Ireland, Italy, Spain, Switzerland and the United Kingdom) and in the United
States (with a term until 2028) and one pending application in the United States; and the second patent family has patents granted in
India, Mexico and the United States. We also have 8 granted patents in the United States (with a term until 2040) and 2 patent applications
pending in the United States covering the methods of use of Epsolay for the treatment of rosacea.
We have two patents granted in the United States (with a term until
2041) and pending applications in Australia, Brazil, Chile, Colombia, Korea, Malaysia, New Zealand, Thailand, South Africa,
and in the United States covering the compositions of Epsolay and Twyneo, the processes for the encapsulation of the active agents
of our Epsolay and Twyneo, the processes for the encapsulation of the active agents of our Epsolay and Twyneo, and the methods of use.
We have four registered trademarks in Europe (including United
Kingdom), Canada, the United States, Australia, Mexico and Israel. These registrations cover potential brand names for our Epsolay in
Israel, Europe, Canada, Australia, Mexico and the United States. Epsolay was also filed for registration in Brazil, Norway, Iceland,
Serbia, Bosnia & Herzegovina, Montenegro, Albania, North Macedonia, South Korea, Kosovo, and South Africa
For SGT-210, we have seven pending applications in Israel, Korea, Mexico
and the United States, and one granted patent in the United States that refer to methods and compositions of use in the treatment of psoriasis.
Competition
The pharmaceutical industry is subject to intense competition as
well as rapid technological changes. Our ability to compete is based on a variety of factors, including product efficacy, safety, cost-effectiveness,
patient compliance, patent position and effective product promotion. Competition is also based upon the ability of a company to offer
a broad range of other product offerings, large direct sales forces and long-term customer relationships with target physicians.
There are numerous companies that have branded or generic products
or product candidates in the dermatology market. Among them are Aclaris Therapeutics, Inc., Akorn, Inc., Almirall S.A., Aqua Pharmaceuticals
LLC, Arcutis Biotherapeutics, Bausch Health Companies Inc., Bayer HealthCare AG, Cassiopea SpA, Organon, Galderma Pharma
S.A., Glenmark Pharmaceuticals Ltd., G&W Laboratories, Inc., LEO Pharma A/S, Mylan N.V., Mayne Pharma, Novan, Inc., Novartis AG, Palvella
Therapeutic, Padagis US LLC, Pfizer, Inc., Spear Therapeutics, Ltd., Sun Pharmaceutical Industries Ltd., Teligent, Inc., Teva Pharmaceutical
Industries Ltd. And Vyne Pharmaceuticals Ltd.
In order for Twyneo, Epsolay and our product candidates, if approved,
to compete successfully in the dermatology market, we will have to demonstrate that their efficacy, safety and cost-effectiveness provide
an attractive alternative to existing therapies, some of which are widely known and accepted by physicians and patients, as well as to
future new therapies. Such competition could lead to reduced market share for Twyneo, Epsolay and our product candidates and contribute
to downward pressure on the pricing of Twyneo, Epsolay and our product candidates, which could harm our business, financial condition,
operating results and prospects.
Many of the companies, academic research institutions, governmental
agencies and other organizations involved in the field of dermatology have substantially greater financial, technical and human resources
than we do, and may be better equipped to discover, develop, test and obtain regulatory approvals for products that compete with ours.
They may also be better equipped to manufacture, market and sell products. These companies, institutions, agencies and organizations may
develop and introduce products and drug delivery technologies competitive with or superior to ours which could inhibit our market penetration
efforts.
55
SGT-610 is expected to be the first, if approved, product for the
prevention of new BCCs in Gorlin syndrome patients. We believe that the competition will be limited in the short term after launch.
Twyneo and Epsolay target the well-established acne and rosacea
markets. Twyneo and Epsolay compete with current standard-of-care treatments, whether branded, generic or over-the-counter, as well as
with new treatments to be approved in the future. The current standard-of-care for acne includes topical anti-bacterial drugs such as
benzoyl peroxide that are broadly available over-the-counter, prescription drug products that are based on single retinoid drug products
such as Differin, Atralin, Retin-A, Retin-A Micro, Tazorac and Altreno, fixed-dose combinations of benzoyl peroxide and adapalene, such
as Epiduo and Epiduo Forte, fixed-dose combinations of benzoyl peroxide and clindamycin, such as Duac, Benzaclin, Onexton and Acanya,
and fixed-dose combinations of benzoyl peroxide, clindamycin and adapalene, such as Cabtreo, fixed-dose combinations of tretinoin and
clindamycin such as Ziana and Veltin, topical antiandrogen such as Winlevi and topical antibiotics such as Aczone and Amzeeq. The current
standard of care for rosacea includes Metrogel, Finacea, Soolantra and Zilxi, as well as oral Oracea (doxycycline embedded in a technology
platform). As a fixed-dose combination product candidate, Twyneo may also compete with drug products utilizing other technologies that
can separate two drug substances, such as dual chamber tubes, dual pouches or dual sachets. In addition to these products, our generic
drug product candidates are expected to face direct competition from branded drugs and authorized generics which are prescription drugs
produced by the branded pharmaceutical companies and marketed under a private label, at generic prices.
Marketing, Sales and Distribution
We currently have limited sales, marketing and distribution capabilities.
In June 2021, we entered into two five-year exclusive license agreements with Galderma pursuant to which Galderma had the exclusive
right to, and is responsible for, all U.S. commercial activities for Twyneo and Epsolay. Pursuant to the agreements, we received
$11 million in upfront payments and regulatory approval milestone payments and were also eligible to receive tiered double-digit royalties
ranging from mid-teen to high-teen percentage of net sales as well as up to $9 million in sales milestone payments. In April 2025, we
sold our rights related to Twyneo and Epsolay in the U.S. to Mayne, following the mutual termination by Sol-Gel and Galderma of the exclusive
five-year license agreements. In June 2023, we entered into exclusive license agreements with Searchlight, pursuant to which, Searchlight
has the exclusive right and is responsible for all commercial activities for Twyneo and Epsolay in Canada, over a fifteen-year term that
is renewable for subsequent five-year periods. In consideration for the grant of such rights, we will receive up to $11 million in potential
upfront payments and regulatory and sales milestones for both drugs, combined. In addition, we will be entitled to royalty percentages
of all Canadian net sales ranging from low-double-digits to high teens. In May 2024, Beimei purchased and licensed the exclusive rights
to commercialize Twyneo in the mainland of China, Hong Kong, Macau, Taiwan and Israel. We have also licensed
the rights to commercialize Twyneo and Epsolay to various licensees in Canada, the majority European countries, U.K and South Africa and
South Korea. We expect to collaborate with third parties that have sales and marketing experience in order to commercialize Twyneo and
Epsolay in other jurisdictions and our product candidates, if approved by the FDA for commercial sale, in lieu of our own sales force
and distribution systems. If we are unable to enter into such arrangements for our product candidates on acceptable terms or at all, we
may not be able to successfully commercialize them. In other markets, we also expect to selectively pursue strategic collaborations with
third parties in order to maximize the commercial potential of our product candidates.
Manufacturing
For the supply of current good manufacturing practice-grade, or
cGMP-grade and clinical trial materials we rely on and expect to continue to rely on third-party CMOs, or on in-house manufacturing capabilities.
As of August 2018, our in-house manufacturing operations have been audited for current good manufacturing, or cGMP, compliance, and were
granted a cGMP certification by the Israel Ministry of Health. This certification allowed us to manufacture Twyneo and its intermediates
to support Phase 3 clinical trials. This cGMP certification expired in 2020, and since no other manufacturing for Phase 3 clinical trials
is planned at the Company during 2021, the Company and the Israel Ministry of Health have mutually concluded that the cGMP certification
will be reassessed and renewed for other products as they reach relevant stages of development. We did not renew our ISO 14001:2015 and
ISO 45001:2018 certifications due to the limited workload in our laboratories, however we continue to maintain all relevant SOPs for safety
and environmental management. For commercial manufacturing of our products, we intend to rely solely on CMOs. It is our policy to have
multiple or alternative sources where possible for every service and material we use in our products.
Government Regulation
Regulation by governmental authorities in Israel, the United States
and other countries is a significant factor in the development, manufacturing and commercialization of Twyneo, Epsolay and our product
candidates and in our ongoing research and development activities. Our business is subject to extensive government regulation in Israel
for its manufacturing activities involving drug products, drug product intermediates, and drug product active substances to be used in
clinical trials.
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Product Approval Process in the United States
Review and approval of drugs
In the United States, pharmaceutical products are subject to
extensive regulation by the FDA. The Federal Food, Drug and Cosmetic Act, or FDCA, and other federal and state statutes and implementing
regulations govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion
and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure
to comply with the applicable U.S. requirements at any time during the product development process, approval process or after approval
may subject an applicant to a variety of administrative or judicial sanctions and enforcement actions brought by the FDA, the Department
of Justice or other governmental entities. Possible sanctions may include the FDA’s refusal to approve pending applications, withdrawal
of an approval, imposition of a clinical hold, issuance of warning letters or untitled letters, product recalls, product seizures, total
or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement and
civil or criminal penalties.
FDA approval of a new drug application is required before any new
unapproved drug or dosage form, can be marketed in the United States. Section 505 of the FDCA describes three types of new drug applications:
(1) an application that contains full reports of investigations of safety and effectiveness (section 505(b)(1)); (2) an application that
contains full reports of investigations of safety and effectiveness but where at least some of the information required for approval comes
from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference (section 505(b)(2));
and (3) an application that contains information to show that the proposed product is comparable in active ingredient, dosage form, strength,
route of administration, labeling, quality, performance characteristics, and intended use, among other things, to a previously approved
product (section 505(j)). Section 505(b)(1) and 505(b)(2) new drug applications are referred to as NDAs, and section 505(j) applications
are referred to as abbreviated NDAs, or ANDAs.
In general, the process required by the FDA prior to marketing
and distributing a new drug, as opposed to a generic drug subject to section 505(j), in the United States usually involves the following:
| • |
completion of pre-clinical (or non-clinical) laboratory tests, animal studies and formulation studies in compliance with the FDA’s
good laboratory practices, or GLP, requirements and other applicable regulations; |
| • |
submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials
in the United States may begin; |
| • |
approval by an independent institutional review board, or IRB, or ethics committee covering each clinical site before each trial
may be initiated at such sites; |
| • |
performance of adequate and well-controlled human clinical trials in accordance with good clinical practice, or GCP, requirements
and other clinical trial-related requirements to establish the safety and efficacy of the proposed drug for its intended use; |
| • |
preparation and submission to the FDA of an NDA; |
| • |
satisfactory completion of an FDA advisory committee review, if applicable; |
| • |
satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product or components
thereof are produced, to assess compliance with current good manufacturing practice, or cGMP, requirements and to assure that the facilities,
methods and controls are adequate to preserve the drug’s identity, strength, quality and purity; |
| • |
satisfactory completion of FDA audits of clinical trial sites to assure compliance with
GCPs and the integrity of the clinical data; and |
| • |
payment of applicable user fees and FDA review and approval of the NDA. |
57
Pre-clinical studies
Pre-clinical studies generally include laboratory evaluation or
product chemistry, formulation and toxicity, as well as animal studies to assess the potential safety and efficacy of the product candidate.
Pre-clinical safety tests must be conducted in compliance with the FDA regulations. The Consolidated Appropriations Act for 2023, amended
the FDCA to specify that nonclinical testing for drugs may, but is not required to, include in vivo animal testing. According to the amended
language, a sponsor may fulfill nonclinical testing requirements by completing various in vitro assays (e.g., cell-based assays, organ
chips, or microphysiological systems), in silico studies (i.e., computer modeling), other human or non-human biology-based tests (e.g.,
bioprinting), or in vivo animal tests. The conduct of nonclinical studies is subject to federal regulations and requirements, including
GLP regulations.
The results of the pre-clinical studies, together with manufacturing
information and analytical data, are submitted to the FDA as part of an IND which must become effective before clinical trials may commence.
An IND is a request for authorization from the FDA to administer an investigational new drug product to humans. The central focus of an
IND submission is on the general investigational plan and the protocol(s) for clinical studies. The IND automatically becomes effective
30 days after receipt by the FDA, unless the FDA, within the 30- day time period, raises safety concerns or questions about the proposed
clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor, and the FDA must resolve any outstanding concerns
or questions before the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a
clinical trial. Long-term non-clinical studies, such as animal tests of reproductive toxicity and carcinogenicity, may continue after
the IND application is submitted.
Clinical trials
Clinical trials involve the administration of an investigational
product to human subjects under the supervision of qualified investigators in accordance with GCP requirements, which include, among other
things, the requirement that all research subjects provide their informed consent in writing before their participation in any clinical
trial. Clinical trials are conducted under written trial protocols detailing, among other things, the objectives of the trial, the parameters
to be used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent
protocol amendments must be submitted to the FDA as part of the IND.
An IRB representing each institution participating in the clinical
trial must review and approve the plan for any clinical trial before it commences at that institution, and the IRB must conduct continuing
review at least annually. The IRB must review and approve, among other things, the trial information to be provided to trial subjects,
including any informed consent forms and other proposed communications with subjects. An IRB must operate in compliance with FDA regulations.
Some studies also include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data
safety monitoring board, which provides authorization for whether or not a study may move forward at designated
check points based on access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable
safety risk for subjects or other grounds, such as no demonstration of efficacy. The FDA or the sponsor may suspend a clinical trial at
any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.
Similarly, an IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted
in accordance with the IRB’s requirements or if the investigational drug has been associated with unexpected serious harm to patients.
Clinical trials are typically conducted in three sequential phases,
which may overlap or be combined:
| • |
Phase 1: The drug is initially introduced into healthy human subjects or patients with the
target disease or condition and tested for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible,
to gain an early indication of its effectiveness and to determine optimal dosage. |
| • |
Phase 2: The drug is administered to a limited patient population to identify possible short-term
adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine
dosage tolerance and optimal dosage. |
| • |
Phase 3: The drug is administered to an expanded patient population, generally at geographically
dispersed clinical trial sites, in well-controlled clinical trials to generate enough data to statistically evaluate the efficacy and
safety of the product for approval, to establish the overall risk-benefit profile of the product, and to provide adequate information
for the labeling of the product. |
58
In some cases, the FDA may require, or companies may voluntarily
pursue, additional clinical trials after a product is approved to gain more information about the product. These so-called Phase 4 studies
may be conducted after initial marketing approval, and may be used to gain additional experience from the treatment of patients in the
intended therapeutic indication. In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of
approval of an NDA.
Congress recently amended the FDCA, as part of the Consolidated
Appropriations Act for 2023, in order to require each sponsor of a Phase 3 clinical trial, or other “pivotal study” of a new
drug to support marketing authorization, to design and submit a diversity action plan for such clinical trial. The action plan must include
the sponsor’s diversity goals for enrollment, as well as a rationale for the goals and a description of how the sponsor will meet
them. A sponsor must submit a diversity action plan to the FDA by the time the sponsor submits the relevant clinical trial protocol to
the agency for review. The FDA may grant a waiver for some or all of the requirements for a diversity action plan. It is unknown at this
time how the diversity action plan may affect Phase 3 trial planning and timing, but if the FDA objects to a sponsor’s diversity
action plan or otherwise requires significant changes to be made, it could delay initiation of the relevant clinical trial.
Sponsors of certain clinical trials generally must register such
trials and disclose certain trial information within specific timeframes to the National Institutes of Health, or NIH, for public dissemination
on the ClinicalTrials.gov data registry. Information related to the investigational product, patient population, phase of investigation,
trial sites and investigators and other aspects of the clinical trial is made public as part of the registration of the clinical trial.
Sponsors are also obligated to disclose the results of their clinical trials after completion, but such disclosures may be delayed in
some cases for up to two years after the date of completion of the trial. Failure to timely register a covered clinical study or to submit
study results as provided for in the law can give rise to civil monetary penalties and also prevent the non-compliant party from receiving
future grant funds from the federal government. The U.S. Department of Health and Human Services’ Final Rule and NIH’s complementary
policy on ClinicalTrials.gov registration and reporting requirements became effective in 2017, and the government has brought enforcement
actions against non-compliant clinical trial sponsors. Competitors may use the publicly available information about clinical trials to
gain knowledge regarding the progress of development programs. Sponsors or distributors of investigational products for the diagnosis,
monitoring, or treatment of one or more serious diseases or conditions must also have a publicly available policy on evaluating and responding
to requests for expanded access requests.
Concurrent with clinical trials, companies usually complete additional
animal studies and must also develop additional information about the chemistry and physical characteristics of the drug and finalize
a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must
be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer must develop methods
for testing the identity, strength, quality and purity of the final drug. In addition, appropriate packaging must be selected and tested,
and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its
shelf life.
While the IND is active and before approval, progress reports summarizing
the results of the clinical trials and nonclinical studies performed since the last progress report must be submitted at least annually
to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse
events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal
or in vitro testing suggesting a significant risk to humans, and any clinically important increased
incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure.
In addition, during
the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission
of an IND, at the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide
an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor
and the FDA to reach agreement on the next phase of development. Sponsors typically use the meetings at the end of the Phase 2 trial to
discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of
the new drug.
ANDA products must be shown to be similar to, and bioequivalent
to, a reference listed drug, or RLD. A product is considered bioequivalent if there is no significant difference in the rate and extent
to which the active ingredient in the generic product and in the RLD becomes available at the site of drug action when administered at
the same molar dose under similar conditions in an appropriately designed study. Accordingly, an applicant typically compares the systemic
exposure profile of the generic test drug product to that of the RLD at the same regimen and exposure period as the RLD to demonstrate
bioequivalence. For most ANDAs, bioequivalence must be shown in human clinical trials, but in some cases, FDA will accept in vitro data.
Specific requirements are typically outlined by FDA in product-specific bioequivalence guidance.
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Submission of an NDA to the FDA
Assuming successful completion of all required testing with all
applicable regulatory requirements, the results of the pre-clinical studies and clinical trials, together with other detailed information,
including among other things information on the manufacture, control and composition of the product and proposed labeling, are submitted
to the FDA as part of an NDA requesting approval to market the product candidate for one or more indications. In particular, an NDA must
demonstrate that the manufacturing methods and quality controls used to produce the drug product are adequate to preserve the drug’s
identity, strength, quality, and purity. Data can come from company-sponsored clinical trials intended to test the safety and effectiveness
of a use of the product, or from a number of alternative sources, including studies initiated by investigators. FDA approval of an NDA
must be obtained before the corresponding drug may be marketed in the United States.
Under the Prescription Drug User Fee Act, as amended, or PDUFA,
each NDA submission is subject to a substantial application user fee, and the sponsor of an approved NDA is also subject to an annual
program fee. The FDA adjusts the PDUFA user fees on an annual basis. The application user fee must be paid at the time of the first submission
of the application, even if the application is being submitted on a rolling basis. Fee waivers or reductions are available in certain
circumstances, including a waiver of the application fee for products with orphan designation or for the first application filed by a
small business.
The FDA has 60 days from its receipt of an NDA to determine whether
the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit
substantive review. The FDA may request additional information rather than accept an NDA for filing. In this event, the NDA must be resubmitted
with the additional information and subject to payment of required user fees. The resubmitted application is also subject to review before
the FDA accepts it for filing. If found complete, the FDA will accept the NDA for filing. Once the submission is accepted for filing,
the FDA begins an in-depth substantive review.
Under PDUFA, the FDA has agreed to certain performance goals
in the review of NDAs through a two-tiered classification system, standard review and priority review. FDA’s goal is to review NDAs
subject to standard review within 10 months of the filing date, or within six months of the filing date for priority review. The FDA,
however, may not approve a drug within these established goals, as the review process is often significantly extended by FDA requests
for additional information or clarification, and its review goals are subject to change from time to time.
During the review process, the FDA reviews the NDA to determine,
among other things, whether the product is safe and effective and whether the facility in which it is manufactured, processed, packed,
or held meets standards designed to assure the product’s continued strength, quality, and purity. The FDA may also refer applications
for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee for review,
evaluation and recommendation as to whether the application should be approved and under what conditions. The FDA is not bound by the
recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. The FDA is not bound
by the recommendation of an advisory committee, but it considers such recommendations carefully when making final decisions on approval.
Before approving an NDA, the FDA will typically inspect the facility
or facilities at which the product is manufactured. The agency will not approve the product unless cGMP compliance is satisfactory. Additionally,
the FDA will typically inspect one or more clinical sites to assure compliance with GCP requirements. If the FDA determines that the application,
manufacturing process or manufacturing facilities are not acceptable, it will outline the deficiencies as part of the review process and
often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA
ultimately may decide that the application does not satisfy the regulatory criteria for approval.
After the FDA evaluates the NDA and the manufacturing facilities,
it issues either an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the product with
specific prescribing information for specific indications. An approval letter authorizes commercial marketing of the product with specific
prescribing information for one or more indications. A complete response letter indicates that the review cycle for an application is
complete and that the application will not be approved in its present form. A complete response letter generally outlines the deficiencies
in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application.
Even with submission of this additional information, the FDA may ultimately decide that an application does not satisfy the regulatory
criteria for approval. If, or when, the deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA,
the FDA will issue an approval letter.
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If a product is approved, the approval will impose limitations
on the indicated uses for which the product may be marketed, may require that warning statements be included in the product labeling,
may require that additional studies or trials be conducted following approval as a condition of the approval, may impose restrictions
and conditions on product distribution, prescribing or dispensing in the form of a risk management plan, or impose other limitations.
For example, as a condition of NDA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to ensure that the
benefits of the drug outweigh the potential risks. The FDA determines the requirement for a REMS, as well as the specific REMS provisions,
on a case-by-case basis. If the FDA determines a REMS is necessary during review of the application, the drug sponsor must submit a proposed
REMS plan to obtain approval for the drug product. A REMS may be required to include various elements, such as a medication guide or patient
package insert, a communication plan to educate healthcare providers of the drug’s risks, limitations on who may prescribe or dispense
the drug, or other elements to assure safe use, such as special training or certification for prescribing or dispensing, dispensing only
under certain circumstances, special monitoring and the use of patient registries. In addition, the REMS must include a timetable to periodically
assess the strategy. The requirement for a REMS can materially affect the potential market and profitability of a drug.
Further changes to some of the conditions established in an approved
application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA approval
of a new NDA or NDA supplement before the change can be implemented, which may require manufacturers to develop additional data or conduct
additional pre-clinical studies and clinical trials. An NDA supplement for a new indication typically requires clinical data similar to
that in the original application, and the FDA uses similar procedures in reviewing NDA supplements as it does in reviewing NDAs.
Fast Track, Priority Review, and Breakthrough Therapy Designations
A sponsor may seek approval of its product candidate under programs
designed to accelerate FDA’s review and approval of new drugs that meet certain criteria. Specifically, new drugs are eligible for
fast track designation if they are intended to treat a serious or life-threatening condition and demonstrate the potential to address
unmet medical needs for the condition. Fast track designation provides increased opportunities for sponsor interactions with the FDA during
preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed, meaning that
the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides
a schedule for the submission of the sections of the application, the FDA agrees to accept the sections and determines that the schedule
is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application. A fast track designated
product candidate may also qualify for accelerated approval (described below) or priority review, under which the FDA sets the target
date for FDA action on the NDA or biologics license application at six months after the FDA accepts the application for filing.
Priority review is granted when there is evidence that the proposed
product would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition.
Significant improvement may be illustrated by evidence of increased effectiveness in the treatment of a condition, elimination or substantial
reduction of a treatment-limiting drug reaction, documented enhancement of patient compliance that may lead to improvement in serious
outcomes, or evidence of safety and effectiveness in a new subpopulation. If criteria are not met for priority review, the application
is subject to the standard FDA review period of 10 months after FDA accepts the application for filing.
In addition, a sponsor may seek FDA designation of its product
candidate as a breakthrough therapy if the product candidate is intended, alone or in combination with one or more other drugs or biologics,
to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the therapy may demonstrate
substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects
observed early in clinical development. Breakthrough therapy designation provides all the features of fast track designation in addition
to intensive guidance on an efficient development program beginning as early as Phase 1, and FDA organizational commitment to expedited
development, including involvement of senior managers and experienced review and regulatory staff in a proactive, collaborative, cross-disciplinary
review, where appropriate. A drug designated as breakthrough therapy is also eligible for accelerated approval if the relevant criteria
are met.
Even if a product qualifies for one or more of these programs,
the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review
or approval will not be shortened. Fast track, priority review and breakthrough therapy designations do not change the scientific or medical
standards for approval or the quality of evidence necessary to support approval but may expedite the development or approval process.
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Accelerated Approval
In addition, products studied for their safety and effectiveness
in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive
accelerated approval from the FDA and may be approved on the basis of adequate and well-controlled clinical trials establishing that the
drug product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA may also grant accelerated
approval for such a drug or biologic when it has an effect on an intermediate clinical endpoint that can be measured earlier than an effect
on irreversible morbidity or mortality, or IMM, and that is reasonably likely to predict an effect on IMM or other clinical benefit,
taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. As a
condition of approval, the FDA may require that a sponsor of a drug receiving accelerated approval perform post-marketing clinical trials
to verify and describe the predicted effect on IMM or other clinical endpoint, and the product may be subject to expedited withdrawal
procedures. Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional
approval.
For the purposes of accelerated approval, a surrogate endpoint
is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical
b`enefit, but is not itself a measure of clinical benefit. Surrogate endpoints can often be measured more easily or more rapidly than
clinical endpoints. An intermediate clinical endpoint is a measurement of a therapeutic effect that is considered reasonably likely to
predict the clinical benefit of a drug or biologic, such as an effect on IMM. The FDA has limited experience with accelerated approvals
based on intermediate clinical endpoints, but has indicated that such endpoints generally may support accelerated approval when the therapeutic
effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding
that the therapeutic effect is reasonably likely to predict the ultimate long-term clinical benefit of a drug.
The accelerated approval pathway is most often used in settings
in which the course of a disease is long and an extended period of time is required to measure the intended clinical benefit of a drug,
even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. For example, accelerated approval has been used
extensively in the development and approval of drugs for treatment of a variety of cancers in which the goal of therapy is generally to
improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large clinical trials
to demonstrate a clinical or survival benefit.
The accelerated approval pathway is usually contingent on a sponsor’s
agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the product candidate’s
clinical benefit. As a result, a product candidate approved on this basis is subject to rigorous post-marketing compliance requirements,
including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the clinical endpoint. Failure to conduct
required post-approval studies, or to confirm the predicted clinical benefit of the product during post-marketing studies, would allow
the FDA to withdraw approval of the product. As part of the Consolidated Appropriations Act for 2023, Congress provided the FDA additional
statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs or biologics previously granted
accelerated approval. Under the act’s amendments to the FDCA, the FDA may require the sponsor of a product being considered for
accelerated approval to have a confirmatory trial underway prior to approval. The sponsor must also submit progress reports on a confirmatory
trial every six months until the trial is complete, and such reports are published on the FDA’s website. The amendments also give
the FDA the option of using expedited procedures to withdraw product approval if the sponsor’s confirmatory trial fails to verify
the claimed clinical benefits of the product.
All promotional materials for product candidates being considered
and approved under the accelerated approval program are subject to prior review by the FDA.
Post-approval Requirements
Any drug products receiving FDA approval will be subject to continuing
regulation by the FDA. Certain requirements include, among other things, record-keeping requirements, reporting of adverse experiences
with the product, providing the FDA with updated safety and efficacy information on an annual basis or more frequently for specific events,
product sampling and distribution requirements, complying with certain electronic records and signature requirements and complying with
FDA promotion and advertising requirements. The promotion and advertising requirements include standards for direct-to-consumer advertising,
prohibitions against promoting drugs for uses or patient populations that are not described in the drug’s approved labeling, known
as “off-label use,” and other promotional activities, such as those considered to be false or misleading.
Although physicians may prescribe legally available drugs for off-label
uses, manufacturers may not encourage, market or promote such off-label uses. As a result, “off-label promotion” has formed
the basis for litigation under the Federal False Claims Act, violations of which are subject to significant civil fines and penalties.
In addition, manufacturers of prescription products are required to disclose annually to the Center for Medicaid and Medicare any payments
made to physicians in the United States under the Physician Payments Sunshine Act of 2012. These payments could be in cash or kind, could
be for any reason, and are required to be disclosed even if the payments are not related to the approved product. A failure to fully disclose
or not report in time could lead to significant penalties.
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The manufacturing of any drug products must comply with applicable
FDA manufacturing requirements contained in the FDA’s cGMP regulations. The FDA’s cGMP regulations include requirements relating
to organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production
and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned
or salvaged products. Drug manufacturers and other entities involved in the manufacture and distribution of approved drugs are also required
to register their establishments and list any products they make with the FDA and to comply with related requirements in certain states.
Changes to the manufacturing process are strictly regulated and often require prior FDA approval before being implemented. FDA regulations
also require investigation and correction of any deviations from cGMP requirements and impose reporting and documentation requirements
upon the sponsor and any third-party manufacturers that the sponsor may decide to use. These entities are further subject to periodic
unannounced inspections by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must
continue to expend time, money and effort in the area of production and quality control to maintain cGMP compliance.
Discovery of problems with a product after approval may result
in serious and extensive restrictions on a product, manufacturer or holder of an approved NDA, as well as lead to potential market disruptions.
These restrictions may include recalls, suspension of a product until the FDA is assured that quality standards can be met, and continuing
oversight of manufacturing by the FDA under a “consent decree,” which frequently includes the imposition of costs and continuing
inspections over a period of many years, as well as possible withdrawal of the product from the market. In addition, changes to the manufacturing
process generally require prior FDA approval before being implemented. Other types of changes to the approved product, such as adding
new indications and additional labeling claims, are also subject to further FDA review and approval. There also are continuing, annual
program user fee requirements for any approved products, as well as new application fees for supplemental applications with clinical data.
The FDA also may require post-marketing testing, or Phase IV testing,
as well as surveillance to monitor the effects of an approved product or place conditions on an approval that could otherwise restrict
the distribution or use of our product candidates.
Once approval is granted, the FDA may withdraw the approval if
compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later
discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing
processes, or failure to comply with regulatory requirements, may result in mandatory revisions to the approved labeling to add new safety
information; imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions
under a REMS program. Other potential consequences include, among other things:
| • |
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
|
| • |
fines, warning letters or holds on post-approval clinical trials; |
| • |
refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or revocation of product approvals;
|
| • |
product seizure or detention, or refusal to permit the import or export of products; or |
| • |
injunctions or the imposition of civil or criminal penalties. |
In addition, the distribution of prescription pharmaceutical products
is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples at the federal
level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws
limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution.
Furthermore, the Drug Supply Chain Security Act, or DSCSA, was enacted with the aim of building an electronic system to identify and trace
certain prescription drugs distributed in the United States, including most biological products. The DSCSA mandates phased-in and resource-intensive
obligations for pharmaceutical manufacturers, wholesale distributors, and dispensers over a ten-year period, which culminated in November
2023. After an additional one-year stabilization period to give entities subject to the DSCSA additional time to finalize interoperable
tracking systems and to ensure supply chain continuity, the applicable requirements under the DSCSA became fully enforceable as of November
27, 2024. From time to time, new legislation and regulations may be implemented that could significantly change the statutory provisions
governing the approval, manufacturing and marketing of products regulated by the FDA. It is impossible to predict whether further legislative
or regulatory changes will be enacted, whether FDA regulations, guidance or interpretations will be changed or what the impact of such
changes, if any, may be.
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Pediatric trials and exclusivity
Even when not pursuing a pediatric indication, under the Pediatric
Research Equity Act of 2003, an NDA or supplement thereto must contain data that is adequate to assess the safety and effectiveness of
the drug product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each
pediatric subpopulation for which the product is safe and effective. A sponsor that is planning to submit a marketing application for
a product that includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must
submit an initial Pediatric Study Plan, or PSP, within 60 days of an end-of-Phase 2 meeting or, if there is no such meeting, as early
as practicable before the initiation of the Phase 3 or Phase 2/3 clinical trial. The initial PSP must contain an outline of the proposed
pediatric trials the sponsor plans to conduct, including trial objectives and design, age groups, relevant endpoints and statistical approach,
or a justification for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial
waiver of the requirement to provide data from pediatric trials along with supporting information. The applicant, the FDA, and the FDA’s
internal review committee must then review the information submitted, consult with each other, and agree upon the PSP. The FDA or the
applicant may request an amendment to the plan at any time.
The FDA may also, on its own initiative or at the request of the
applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full
or partial waivers from the pediatric data requirements.
Separately, pediatric exclusivity is a type of non-patent marketing
exclusivity available in the United States and, if granted, it provides for the attachment of an additional six months of marketing protection
to the term of any existing regulatory exclusivity or listed patents. This six-month exclusivity may be granted if an NDA sponsor submits
pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show the product to be effective
in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s request, the additional
protection is granted. If reports of requested pediatric studies are submitted to and accepted by the FDA within the statutory time limits,
whatever statutory or regulatory periods of exclusivity or patent protection cover the product are extended by six months. This is not
a patent term extension, but it effectively extends the regulatory period during which the FDA cannot approve another application. The
issuance of a written request does not require the sponsor to undertake the described studies.
Orphan Drugs
Under the Orphan Drug Act, the FDA may grant orphan drug designation
to a drug intended to treat a rare disease or condition, defined as a disease or condition with a patient population of fewer than 200,000
individuals in the United States, or a patient population greater than 200,000 individuals in the United States and when there is no reasonable
expectation that the cost of developing and making available the drug in the United States will be recovered from sales in the United
States for that drug. Orphan drug designation must be requested before submitting an NDA. After the FDA grants orphan drug designation,
the generic identity of the therapeutic agent and its potential orphan indication are disclosed publicly by the FDA.
If a drug product that has orphan drug designation subsequently
receives the first FDA approval for a particular active ingredient for the disease for which it has such designation, the product is entitled
to orphan product exclusivity, which means that the FDA may not approve any other applications, including a full NDA, to market the same
drug for the same indication for seven years, except in limited circumstances, such as a showing of clinical superiority to the product
with orphan product exclusivity or if the FDA finds that the holder of the orphan product exclusivity has not shown that it can assure
the availability of sufficient quantities of the orphan product to meet the needs of patients with the disease or condition for which
the drug was designated. Orphan product exclusivity does not prevent the FDA from approving a different drug for the same disease or condition,
or the same drug for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain
research and a waiver of the NDA application user fee.
A drug with orphan drug designation may not receive orphan product
exclusivity if it is approved for a use that is broader than the indication for which it received orphan drug designation. In addition,
orphan product exclusive marketing rights in the United States may be lost if the FDA later determines that the request for designation
was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients
with the rare disease or condition.
Court cases have challenged FDA’s approach to determining
the scope of orphan drug exclusivity; however, at this time the agency continues to apply its long-standing interpretation of the governing
regulations and has stated that it does not plan to change any orphan drug implementing regulations.
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The Hatch-Waxman Amendments
ANDA Approval Process
The Hatch-Waxman Amendments established abbreviated FDA approval
procedures for drugs that are shown to be equivalent to proprietary drugs previously approved by the FDA through the NDA process. Approval
to market and distribute these drugs is obtained by submitting an ANDA to the FDA. An ANDA is a comprehensive submission that contains,
among other things, data and information pertaining to the active pharmaceutical ingredient, drug product formulation, specifications
and stability of the generic drug, as well as analytical methods, manufacturing process validation data, and quality control procedures.
Premarket applications for generic drugs are termed abbreviated because they generally do not include pre-clinical and clinical data to
demonstrate safety and effectiveness. Instead, a generic applicant must demonstrate that its product is bioequivalent to a drug product
previously approved under an NDA, known as the reference listed drug, or RLD, and may rely on the preclinical and clinical testing previously
conducted for the RLD. Under the statute, a generic drug is bioequivalent to an RLD if “the rate and extent of absorption
of the drug do not show a significant difference from the rate and extent of absorption of the listed drug.”.
In certain situations, the FDA may permit an applicant to submit
an ANDA for a generic product with a route of administration, strength or dosage form that differs from an RLD, or that has one different
active ingredient from an RLD if the product is a fixed-combination drug, pursuant to the filing and approval of a suitability petition.
The FDA will permit the submission of an ANDA in such cases if it finds, among other things, that the proposed generic product does not
raise new questions of safety and effectiveness as compared to the RLD. A product is not eligible for ANDA approval if the FDA determines
that it is not bioequivalent to the RLD, if it is intended for a different use, or if it is not subject to an approved suitability petition.
However, such a product might be approved under an NDA, with supportive data from clinical trials.
505(b)(2) NDAs
Section 505(b)(2) was enacted as part of the Hatch-Waxman Amendments
and permits the filing of an NDA where at least some of the information required for approval comes from studies or trials not conducted
by or for the applicant and for which the applicant has not obtained a right of reference. Section 505(b)(2) typically serves as an alternative
path to FDA approval for modifications to formulations or uses of products previously approved by the agency. If the 505(b)(2) applicant
can establish that reliance on the FDA’s previous findings of safety and effectiveness is scientifically appropriate, it may eliminate
the need to conduct certain pre-clinical studies or clinical trials for the new product. The FDA may also require companies to perform
additional studies or measurements, including clinical trials, to support the change from the approved reference drug. The FDA may then
approve the new product candidate for all, or some, of the labeled indications for which the reference drug has been approved, as well
as for any new indication sought by the 505(b)(2) applicant.
Orange Book Listing
In seeking approval for a drug through an NDA, including a 505(b)(1)
and 505(b)(2) NDA, applicants are required to list with the FDA certain patents whose claims cover the applicant’s product or method
of using the product. Upon approval of an NDA, each of the patents listed in the application for the drug is then published in the FDA’s
publication of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the “Orange Book.” Any applicant
who submits an ANDA seeking approval of a generic equivalent of a drug listed in the Orange Book or a Section 505(b)(2) NDA referencing
a drug listed in the Orange Book must certify to the FDA that (1) the required patent information on the drug product has not been filed
by the original applicant; (2) the listed patent has expired; (3) the listed patent has not expired but will expire on a particular date
and approval for the follow-on product is sought after patent expiration; or (4) that such patent is invalid, unenforceable or will not
be infringed by the manufacture, use or sale of the follow-on drug product. This last certification is known as a Paragraph IV certification.
The applicant may also elect to submit a “section viii” statement certifying that it is not seeking approval for the proposed
label does not contain (or carves out) any language regarding a condition of use that is the subject of a valid listed patent for the
RLD.
If a Paragraph I or II certification is filed, the FDA may make
approval of the application effective immediately upon completion of its review. If a Paragraph III certification is filed, the approval
may be made effective on the patent expiration date specified in the application, although a tentative approval may be issued before that
time. Further, the FDA will also not approve, as applicable, an ANDA or Section 505(b)(2) NDA until any non-patent exclusivity, as described
in greater detail below, has expired.
If the ANDA or Section 505(b)(2) NDA applicant has provided a Paragraph
IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and relevant patent holders
within 20 days after the ANDA or Section 505(b)(2) NDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate
a patent infringement suit against the ANDA or Section 505(b)(2) applicant. Under the FDCA, the filing of a patent infringement lawsuit
within 45 days of receipt of the notification regarding a Paragraph IV certification automatically prevents the FDA from approving the
ANDA or Section 505(b)(2) NDA until the earliest to occur of 30 months beginning on the date of receipt of the Paragraph IV certification
notice, expiration of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA or 505(b)(2)
applicant. Even if a patent infringement claim is not brought within the 45-day period, a patent infringement claim may be brought under
traditional patent law, but it does not invoke the 30-month stay. The court may shorten or lengthen either the 30-month or the seven and
one-half year period if either party is found not to be reasonably cooperating in expediting the litigation.
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Non-Patent Exclusivity
In addition to patent exclusivity, NDA holders may be entitled
to a period of non-patent exclusivity, during which the FDA may not approve an ANDA or 505(b)(2) application that relies on the listed
drug. For example, a pharmaceutical manufacturer may obtain five years of non-patent exclusivity upon NDA approval of a new chemical entity,
or NCE, which is a drug that contains an active moiety that has not been approved by FDA in any other NDA. An “active moiety”
is defined as the molecule or ion responsible for the drug substance’s physiological or pharmacologic action. During the five year
exclusivity period, the FDA cannot accept for filing any ANDA seeking approval of a generic version of that drug or any 505(b)(2) NDA
for the same active moiety and that relies on the FDA’s findings regarding that drug, except that FDA may accept an application
for filing after four years if the ANDA or 505(b)(2) applicant makes a Paragraph IV certification.
The FDCA also provides for a period of three years of exclusivity
for an NDA, 505(b)(2) NDA or supplement thereto if one or more new clinical investigations, other than bioavailability or bioequivalence
studies, that were conducted by or for the applicant are deemed by the FDA to be essential to the approval of the application. This three-year
exclusivity period often protects changes to a previously approved drug product, such as a new dosage form, route of administration, combination
or indication. The three-year exclusivity covers only the conditions of use associated with the new clinical investigations and does not
prohibit the FDA from approving follow-on applications for drugs containing the original active agent. Should this occur, the FDA would
be precluded from approving any ANDA or 505(b)(2) application for the protected modification until after that three-year exclusivity period
has run. However, unlike NCE exclusivity, the FDA can accept an application and begin the review process during the exclusivity period.
Review and Approval of Drug Products
Outside the United States
To market any product outside of the United States, we would need
to comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy and governing, among other
things, manufacturing, clinical trials, marketing authorization, commercial sales and distribution of our products. The foreign regulatory
approval process includes all of the risks associated with FDA approval set forth above, as well as additional country-specific regulation.
Whether or not we obtain FDA approval for a product candidate, we must obtain approval of the product by the comparable regulatory authorities
of foreign countries before commencing clinical trials or marketing in those countries. Approval by one regulatory authority does not
ensure approval by regulatory authorities in other jurisdictions. The approval process varies from country to country, and the time may
be longer or shorter than that required for FDA approval. The requirements governing the conduct of clinical trials, product licensing,
pricing, promotion and reimbursement vary greatly from country to country.
Non-clinical Studies and Clinical Trials in the EU
Similarly to the United States, the various phases of non-clinical
and clinical research in the EU are subject to significant regulatory controls.
Non-clinical studies are performed to demonstrate the health or
environmental safety of new chemical or biological substances. Non-clinical (pharmaco-toxicological) studies must be conducted in compliance
with the principles of GLP as set forth in EU Directive 2004/10/EC (unless otherwise justified for certain particular medicinal products
– e.g., radio-pharmaceutical precursors for radio-labeling purposes). In particular, non-clinical studies, both in vitro and in
vivo, must be planned, performed, monitored, recorded, reported and archived in accordance with the GLP principles, which define a set
of rules and criteria for a quality system for the organizational process and the conditions for non-clinical studies. These GLP standards
reflect the Organization for Economic Co-operation and Development requirements.
Clinical trials of medicinal products in the EU must be conducted
in accordance with EU and national regulations and the International Council for Harmonization of Technical Requirements for Pharmaceuticals
for Human Use, or ICH, guidelines on GCP as well as the applicable regulatory requirements and the ethical principles that have their
origin in the Declaration of Helsinki. If the sponsor of the clinical trial is not established within the EU, it must appoint an EU entity
to act as its legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU member states, the sponsor
is liable to provide ‘no fault’ compensation to any study subject injured in the clinical trial.
The regulatory landscape related to clinical trials in the EU has
been subject to recent changes. The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical
Trials Directive, became applicable on January 31, 2022. Unlike directives, the CTR is directly applicable in all EU member states without
the need for member states to further implement it into national law. The CTR notably harmonizes the assessment and supervision processes
for clinical trials throughout the EU via a Clinical Trials Information System, which contains a centralized EU portal and database.
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While the EU Clinical Trials Directive required a separate clinical
trial application, or CTA, to be submitted in each member state in which the clinical trial takes place, to both the competent national
health authority and an independent ethics committee, much like the FDA and IRB respectively, the CTR introduces a centralized process
and only requires the submission of a single application for multi-center trials. The CTR allows sponsors to make a single submission
to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The CTA must
include, among other things, a copy of the trial protocol and an investigational medicinal product dossier containing information about
the manufacture and quality of the medicinal product under investigation. The assessment procedure of the CTA has been harmonized as well,
including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements
related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized
EU portal. Once the CTA is approved, clinical study development may proceed.
As of January 31, 2025, all clinical trials (including those which
are ongoing) are subject to the provisions of the CTR.
Medicinal product candidates used in clinical trials must be manufactured in accordance with applicable
cGMP requirements. Other national and EU-wide regulatory requirements may also apply.
Marketing Authorization
In order to market our product candidates in the EU and many
other foreign jurisdictions, we must obtain separate regulatory approvals. More concretely, in the EU, medicinal product candidates can
only be commercialized after obtaining a marketing authorization, or MA. To obtain regulatory approval of a product candidate under EU
regulatory systems, we must submit a MA application, or MAA. The process for doing this depends, among other things, on the nature of
the medicinal product. There are two types of MAs:
| • |
“Centralized MAs” are issued by the EC through the centralized procedure based on the opinion of the Committee for Medicinal
Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, and are valid throughout the EU. The centralized procedure
is compulsory for certain types of medicinal products such as (i) medicinal products derived from biotechnological processes, (ii) designated
orphan medicinal products, (iii) advanced therapy medicinal products, or ATMPs (such as gene therapy, somatic cell therapy and tissue
engineered products) and (iv) medicinal products containing a new active substance indicated for the treatment of certain diseases, such
as HIV/AIDS, cancer, diabetes, neurodegenerative diseases or autoimmune diseases and other immune dysfunctions, and viral diseases. The
centralized procedure is optional for products that do not meet such criteria and that contain a new active substance not yet authorized
in the EU, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest
of public health in the EU. |
| • |
“National MAs” are issued by the competent authorities of the EU member states, only cover their respective territory,
and are available for product candidates not falling within the mandatory scope of the centralized procedure. Where a product has already
been authorized for marketing in an EU member state, this national MA can be recognized in another member state through the mutual recognition
procedure. If the product has not received a national MA in any member state at the time of application, it can be approved simultaneously
in various member states through the decentralized procedure. Under the decentralized procedure an identical dossier is submitted to the
competent authorities of each of the member states in which the MA is sought, one of which is selected by the applicant as the reference
member state. |
Under the centralized procedure the maximum timeframe for the evaluation
of an MAA by the EMA is 210 days, excluding clock stops. Accelerated evaluation may be granted by the CHMP in exceptional cases,
when a medicinal product is expected to be of a major public health interest from the point of view of therapeutic innovation, defined
by three cumulative criteria: the seriousness of the disease to be treated; the absence of an appropriate alternative therapeutic approach,
and anticipation of exceptional high therapeutic benefit. In this circumstance, the EMA ensures that the evaluation for the opinion of
the CHMP is completed within 150 days, excluding clock stops.
Under the above described procedures, in order to grant the MA,
the EMA or the competent authorities of the EU member states make an assessment of the risk benefit balance of the product on the basis
of scientific criteria concerning its quality, safety and efficacy. MAs have an initial duration of five years. After these five years,
the authorization may be renewed on the basis of a reevaluation of the risk-benefit balance. Once renewed, the marketing authorization
is valid for an unlimited period, unless the EC, or the applicable competent authority decides on justified grounds relating to pharmacovigilance,
to proceed with one additional five-year renewal. Any marketing authorization which is not followed by the actual placing of the drug
on the market in the EU (in case of centralized procedure) or on the market in the authorizing member state within three years after authorization
ceases to be valid (the so-called sunset clause).
In April 2023 the EC adopted a legislative proposal to revise and
replace the existing general pharmaceutical legislation. As of March 2025, the proposal is under technical examination by the Council
of the EU. If such revisions are ultimately implemented, they will significantly change several aspects of drug development and approval
in the EU.
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Data and Marketing Exclusivity
In the EU, new products authorized for marketing (i.e., reference
products) generally receive eight years of data exclusivity and an additional two years of market exclusivity upon MA. If granted, the
data exclusivity period prevents generic and biosimilar applicants from relying on the preclinical and clinical trial data contained in
the dossier of the reference product when applying for a generic or biosimilar MA in the EU during a period of eight years from the date
on which the reference product was first authorized in the EU. The market exclusivity period prevents a successful generic or biosimilar
applicant from commercializing its product in the EU until 10 years have elapsed from the initial MA of the reference product in the EU.
The overall 10-year market exclusivity period can be extended to a maximum of 11 years if, during the first eight years of those 10 years,
the MA holder obtains an authorization for one or more new therapeutic indications, which, during the scientific evaluation prior to their
authorization, are held to bring a significant clinical benefit in comparison with existing therapies. However, there is no guarantee
that a product will be considered by the EU’s regulatory authorities to be a new chemical or biological entity, and products may
not qualify for data exclusivity.
Orphan Medicinal Products
The criteria for designating an “orphan medicinal product”
in the EU are similar in principle to those in the United States. A medicinal product can be designated as an orphan if its sponsor can
establish that: (1) the product is intended for the diagnosis, prevention or treatment of a life threatening or chronically debilitating
condition (2) either (a) such condition affects not more than five in 10,000 persons in the EU when the application is made, or (b) the
product, without the benefits derived from the orphan status, would not generate sufficient return in the EU to justify the necessary
investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been
authorized for marketing in the EU or, if such method exists, the proposed orphan product will be of significant benefit to those affected
by such condition.
Orphan designation must be requested before submitting an MAA.
An EU orphan designation entitles a party to incentives such as reduction of fees or fee waivers, protocol assistance, and access to the
centralized procedure. Upon grant of a MA, orphan medicinal products are entitled to 10 years of market exclusivity for the approved indication,
which means that the competent authorities cannot accept another MAA, or grant a MA, or accept an application to extend a MA for a similar
medicinal product for the same indication during such period. The period of market exclusivity is extended by two years for orphan medicinal
products that have also complied with an agreed pediatric investigation plan, or PIP. No extension to any supplementary protection certificate
can be granted on the basis of pediatric studies for orphan indications. Orphan designation does not convey any advantage in, or shorten
the duration of, the regulatory review and approval process.
The orphan exclusivity period may be reduced to six years if, at
the end of the fifth year, it is established that the product no longer meets the criteria for which it received orphan destination, including
where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence
of the condition has increased above the threshold. Additionally, MA may be granted to a similar medicinal product for the same indication
at any time if (i) the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically
superior; (ii) the applicant consents to a second orphan medicinal product application; or (iii) the applicant cannot supply enough orphan
medicinal product.
Pediatric Development
In the EU, MAAs for new medicinal products have to include the
results of studies conducted in the pediatric population, in compliance with a PIP agreed with the EMA’s Pediatric Committee, or
PDCO. The PIP sets out the timing and measures proposed to generate data to support a pediatric indication of the drug for which MA is
being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient
data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data
can be waived by the PDCO when these data is not needed or appropriate because the product is likely to be ineffective or unsafe in children,
the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a
significant therapeutic benefit over existing treatments for pediatric patients. Once the MA is obtained in all the EU member states and
study results are included in the product information, even when negative, the product is eligible for six months’ supplementary
protection certificate extension (if any is in effect at the time of approval) or, in the case of orphan pharmaceutical products, a two
year extension of the orphan market exclusivity is granted.
The aforementioned EU rules are generally applicable in the European
Economic Area, or EEA, which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland.
Failure to comply with EU and member state laws that apply to the
conduct of clinical trials, manufacturing approval, MA of medicinal products and marketing of such products, both before and after grant
of the MA, manufacturing of pharmaceutical products, statutory health insurance, bribery and anti-corruption or with other applicable
regulatory requirements may result in administrative, civil or criminal penalties. These penalties could include delays or refusal to
authorize the conduct of clinical trials, or to grant MA, product withdrawals and recalls, product seizures, suspension, withdrawal or
variation of the MA, total or partial suspension of production, distribution, manufacturing or clinical trials, operating restrictions,
injunctions, suspension of licenses, fines and criminal penalties.
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Pharmaceutical Coverage, Pricing and Reimbursement
Significant uncertainty exists as to the coverage and reimbursement
status of Twyneo, Epsolay, and any product candidates for which we obtain regulatory approval. In the United States and other markets,
sales of any product candidates for which we receive regulatory approval for commercial sale will depend in part on the availability of
coverage and reimbursement from third-party payors. Third-party payors include government health administrative authorities, managed care
providers, private health insurers and other organizations. The process for determining whether a payor will provide coverage for a drug
product may be separate from the process for setting the price or reimbursement rate that the payor will pay for the drug product. Third-party
payors may limit coverage to specific drug products on an approved list, or formulary, which might not include all of the FDA-approved
drug products for a particular indication.
Third-party payors are increasingly challenging the price and
examining the medical necessity and cost-effectiveness of medical products and services, in addition to their safety and efficacy. We
or our licensing partners may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness
of Epsolay, Twyneo or any of our product candidates that may receive regulatory approval. For example, some third-party payors may not
consider Epsolay, Twyneo or any of our product candidates that may receive regulatory approval medically necessary or cost-effective and
may decide to impose coverage or other utilization limits on their use. A payor’s decision to provide coverage for a drug product
does not imply that an adequate reimbursement rate will be approved. Adequate third-party payor reimbursement may not be available to
enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development.
In international markets, reimbursement and healthcare payment
systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies. In the EU,
pricing and reimbursement schemes vary widely from country to country. Some countries operate positive and negative list systems under
which products may be marketed only after a reimbursement price has been agreed to by the government. To obtain reimbursement or pricing
approval, some countries may require the completion of additional studies or trials that compare the cost-effectiveness of a particular
product candidate to currently available therapies. For example, the EU provides options for its member states to restrict the range of
drug products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products
for human use. EU member states may approve a specific price or level of reimbursement for a pharmaceutical product, or it may instead
adopt a system of direct or indirect controls on the profitability of the company placing the pharmaceutical product on the market, including
volume-based arrangements, caps and reference pricing mechanisms. Other member states allow companies to fix their own prices for drug
products but monitor and control company profits. There can be no assurance that any country that has price controls or reimbursement
limitations for pharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. The downward
pressure on health care costs in general, particularly prescription drugs, has become intense. As a result, there are increasingly high
barriers to entry for new products. In addition, in some countries, cross-border imports from low-priced markets exert competitive pressure
that may reduce pricing within a country. Any country that has price controls or reimbursement limitations for drug products may not allow
favorable reimbursement and pricing arrangements.
Healthcare Reform
In the United States and some foreign jurisdictions, there have
been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent
or delay marketing approval of product and therapeutic candidates, restrict or regulate post-approval activities, and affect the ability
to profitably sell product and therapeutic candidates that obtain marketing approval. The FDA’s and other regulatory authorities’
policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our
product and therapeutic candidates. In addition, future legislative and regulatory proposals may materially impact the ability of the
FDA and other regulatory agencies to operate as they have historically operated. We cannot be sure whether additional legislative changes
will be enacted, or whether any of the FDA’s regulations, guidances or interpretations will be changed, or what the impact of such
changes on the agency and its scientific review staff, if any, may be. For example, the next FDA user fee reauthorization package is expected
to enter stakeholder negotiations beginning in mid-2025, with any agreement sent to Congress in early 2027 for purposes of initiating
the legislative process. Reauthorization of the prescription drug user fee program would need to be finalized by Congress by the end of
September 2027 in order to avoid a disruption in FDA’s review goals for NDAs and other activities supported by user fees assessed
against industry. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies,
or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we otherwise may have obtained and we
may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.
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As previously mentioned, the primary trend in the U.S. healthcare
industry and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting
coverage and the amount of reimbursement for particular medical products and services, implementing reductions in Medicare and other healthcare
funding and applying new payment methodologies. The U.S. Congress has considered reductions in Medicare reimbursement levels for medicines
administered by physicians. CMS, the agency that administers the Medicare and Medicaid programs, also has authority to revise reimbursement
rates and to implement coverage restrictions for most drugs and biologics. Cost reduction initiatives and changes in coverage implemented
through legislation or regulation could decrease utilization of and reimbursement for any approved products we may market in the future.
While Medicare regulations apply only to pharmaceutical benefits for Medicare beneficiaries, private payors often follow Medicare coverage
policy and payment limitations in setting their own reimbursement rates. Therefore, any reduction in reimbursement that results from federal
legislation or regulation may result in a similar reduction in payments from private payors.
In recent years, there has been heightened governmental scrutiny
over the manner in which manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and
proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review
the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug
products. Notably, the CREATES Act, which became effective on December 20, 2019, addresses concerns articulated by both the FDA and others
in the industry that some brand manufacturers have improperly restricted the distribution of their products, including by invoking the
existence of a REMS for certain products, to deny generic and biosimilar product developers access to samples of brand products. Because
generic and biosimilar product developers need samples to conduct certain comparative testing required by the FDA, some have attributed
the inability to timely obtain samples as a cause of delay in the entry of generic and biosimilar products. To remedy this concern, the
CREATES Act establishes a private cause of action that permits a generic or biosimilar product developer to sue the brand manufacturer
to compel it to furnish the necessary samples on “commercially reasonable, market-based terms.” Although lawsuits have been
filed under the CREATES Act since its enactment, those lawsuits have settled privately; therefore, to date no federal court has reviewed
or opined on the statutory language and there continues to be uncertainty regarding the scope and application of the law.
More recently, in August 2022, the IRA was signed into law. Among
other things, the IRA has multiple provisions that may impact the prices of drug products that are both sold into the Medicare program
and throughout the United States. For example, a manufacturer of a drug or biological product covered by Medicare Parts B or D must pay
a rebate to the federal government if the drug product’s price increases faster than the rate of inflation. This calculation is
made on a product-by-product basis and the amount of the rebate owed to the federal government is directly dependent on the volume of
a drug product that is paid for by Medicare Parts B or D. Additionally, starting in payment year 2026, CMS will negotiate drug prices
annually for a select number of single-source Part D drugs without generic or biosimilar competition. CMS will also negotiate drug prices
for a select number of Part B drugs starting for payment year 2028. If a drug product is selected by CMS for negotiation, it is expected
that the revenue generated from such drug will decrease. CMS has begun to implement these new authorities and entered into the first set
of agreements with drug and biologic manufacturers for negotiated prices of 10 products, which will become applicable for payment year
2026. However, the IRA’s impact on the pharmaceutical industry in the United States remains uncertain, in part because multiple
large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce) have initiated federal lawsuits against CMS
arguing the program is unconstitutional for a variety of reasons, among other complaints. Those lawsuits are currently ongoing.
At the state level, individual states are increasingly aggressive
in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price
or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency
measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, in recent years,
several states have formed prescription drug affordability boards, or PDABs. Much like the IRA’s drug price negotiation program,
these PDABs have attempted to implement upper payment limits, or UPLs, on drugs sold in their respective states in both public and commercial
health plans. For example, in August 2023, Colorado’s PDAB announced a list of five prescription drugs that would undergo an affordability
review. The effects of these efforts remain uncertain pending the outcomes of several federal lawsuits challenging state authority to
regulate prescription drug payment limits. We expect that federal, state and local governments in the United States will continue to consider
legislation directed at lowering the total cost of health care. In December 2020, the U.S. Supreme Court held unanimously that federal
law does not preempt the states’ ability to regulate PBMs and other members of the healthcare and pharmaceutical supply chain, an
important decision that may lead to further and more aggressive efforts by states in this area. The FTC in mid-2022 also launched sweeping
investigations into the practices of the PBM industry that could lead to additional federal and state legislative or regulatory proposals
targeting such entities’ operations, pharmacy networks, or financial arrangements. Significant efforts to change the PBM industry
as it currently exists in the United States may affect the entire pharmaceutical supply chain and the business of other stakeholders,
including pharmaceutical developers like us. In addition, regional healthcare authorities and individual hospitals are increasingly using
bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other
healthcare programs. These measures could reduce the ultimate demand for our products, once approved, or put pressure on our product pricing.
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Similar political, economic and regulatory developments are
occurring in the EU and may affect the ability of pharmaceutical companies to profitably commercialize their products. In addition to
continuing pressure on prices and cost containment measures, legislative developments at the EU or member state level may result in significant
additional requirements or obstacles. The delivery of healthcare in the EU, including the establishment and operation of health services
and the pricing and reimbursement of medicines, is almost exclusively a matter for national, rather than EU, law and policy. National
governments and health service providers have different priorities and approaches to the delivery of health care and the pricing and reimbursement
of products in that context. In general, however, the healthcare budgetary constraints in most EU member states have resulted in restrictions
on the pricing and reimbursement of medicines by relevant health service providers. Coupled with ever-increasing EU and national regulatory
burdens on those wishing to develop and market products, this could restrict or regulate post-approval activities and affect the ability
of pharmaceutical companies to commercialize their products. In international markets, reimbursement and healthcare payment systems vary
significantly by country, and many countries have instituted price ceilings on specific products and therapies.
On December 13, 2021, Regulation No 2021/2282 on Health Technology
Assessment, or HTA, amending Directive 2011/24/EU, was adopted. While the Regulation entered into force in January 2022, it will only
begin to apply from January 2025 onwards, with preparatory and implementation-related steps to take place in the interim. Once applicable,
it will have a phased implementation depending on the concerned products. The Regulation intends to boost cooperation among EU member
states in assessing health technologies, including new medicinal products, and provide the basis for cooperation at the EU level for joint
clinical assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and procedures across the
EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential
impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging
health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member
states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and
making decisions on pricing and reimbursement.
We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. We expect
that additional federal, state and foreign healthcare initiatives will be adopted in the future, any of which could impact the coverage
and reimbursement for drugs, including Twyneo Epsolay and any of our product candidates that may receive regulatory approval.
Healthcare Laws and Regulations
Our current and future business operations may be subject to
additional healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions
in which we conduct our business. In the U.S., such laws include, without limitation, state and federal anti-kickback, fraud and abuse,
false claims, price reporting and physician and other healthcare provider payment transparency laws. Some of our pre-commercial activities,
and our or our licensing partners’ commercial activities, in the U.S. are subject to such laws, some of which are described below.
The federal Anti-Kickback Statute makes it illegal for any person
or entity or a party acting on its behalf to knowingly and willfully solicit, receive, offer, or pay any remuneration, directly or indirectly,
overtly or covertly, to induce, or in return for, the referral of business, including the purchase, order, lease or recommendation of
or arrangement for any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare
program, such as Medicare or Medicaid. The term “remuneration” has been broadly interpreted to include anything of value,
including cash, improper discounts, and free or reduced-price items and services. The Anti-Kickback Statute has been interpreted to apply
to arrangements between pharmaceutical manufacturers on one hand and prescribers, purchasers, formulary managers, and beneficiaries on
the other. Although there are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution,
the exceptions and safe harbors are drawn narrowly. Practices that involve remuneration that may be alleged to be intended to induce prescribing,
purchases or recommendations may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of
the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under
the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review
of all its facts and circumstances. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose
of an arrangement involving remuneration is to induce referrals of federal healthcare covered business, the Anti-Kickback Statute has
been violated. In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it
in order to have committed a violation.
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The federal civil False Claims Act, or FCA, prohibits, among other
things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, the federal government,
including any federal healthcare program, claims for items or services, including drugs, that are false or fraudulent or not provided
as claimed, from knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent
claim, or from knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.
Persons and entities can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent
claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. Drug manufacturers
can be held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause”
the submission of false or fraudulent claims. The FCA also permits a private individual acting as a “whistleblower” to bring
actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. Our or our licensing
partners’ activities relating to the reporting of wholesaler or estimated retail prices for our products or product candidates,
once approved, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and
third-party reimbursement for our products and product candidates, once approved, and the sale and marketing of our products and product
candidates, once approved, are subject to scrutiny under the FCA. Moreover, a claim including items or services resulting from a violation
of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.
HIPAA created new federal criminal statutes that prohibit among
other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including
private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a
criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making
any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items
or services. Like the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific
intent to violate it in order to have committed a violation.
HIPAA, as amended by the HITECH Act and its implementing regulations,
also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
individually identifiable health information.
The Civil Monetary Penalties Law prohibits, among other things,
the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than
fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence
the beneficiary’s selection of a particular supplier of items or services reimbursable by a federal or state governmental program.
The federal Physician Payment Sunshine Act requires certain manufacturers
of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health
Insurance Program (with certain exceptions) to report annually to the federal government information about such manufacturers’
payments and other “transfers of value” provided to physicians, certain non-physician advanced healthcare practitioners, and
teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, such entities, as well as certain ownership
and investment interests held by physicians as defined by statute and their immediate family members.
Many U.S. states have similar fraud and abuse statutes or regulations
that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other
state programs. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance
guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report
information related to payments to clinicians and other healthcare providers or marketing expenditures. Some states and local jurisdictions
require the registration of pharmaceutical sales representatives. State and foreign laws also govern the privacy and security of health
information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus
complicating compliance efforts.
Additionally, to the extent that any of our products or product
candidates, once approved, are sold in a foreign country, we may be subject to similar foreign laws and regulations, which may also be
broader in scope than the provisions described above. These laws and regulations may differ from one another in significant ways, thus
further complicating compliance efforts. For instance, in the EU, many EU member states have adopted specific anti-gift statutes that
further limit commercial practices for medicinal products, in particular vis-à-vis healthcare professionals and organizations. Additionally,
there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or entities
and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency requirements (often
on an annual basis), similar to the requirements in the United States, on pharmaceutical companies. Certain countries also mandate implementation
of compliance programs, or require reporting of marketing expenditures and pricing information.
72
If our operations are found to be in violation of any of
such laws or any other governmental regulations that apply to us, we may be subject to penalties, including, without limitation, administrative,
civil and criminal penalties, damages, fines, disgorgement, contractual damages, reputational harm, diminished profits and future earnings,
the curtailment or restructuring of our operations, exclusion from participation in federal and state healthcare programs or similar programs
in other countries or jurisdictions, integrity oversight and reporting obligations, and imprisonment, any of which could adversely affect
our ability to operate our business and our financial results.
Data Privacy and Security Laws
Numerous state, federal and foreign laws, regulations and standards
govern the collection, use, access to, confidentiality and security of health-related and other personal information, many of which differ
from each other in significant ways and apply simultaneously, thus complicating compliance efforts. Such laws, regulations and standards
may apply now or in the future to our operations or the operations of our partners.
HIPAA, as amended by the Health Information Technology for Economic
and Clinical Health (“HITECH”), and its implementing regulations, strengthens and expands requirements relating to the privacy,
security, and transmission of individually identifiable health information; and requires notification to affected individuals and regulatory
authorities of certain breaches of security of individually identifiable health information.
HITECH strengthened and expanded HIPAA and increased penalties
for violations. Under HITECH, regulated entities are subject to enforcement by the federal government and by state Attorneys General,
who were given authority to enforce HIPAA under HITECH. Some state laws impose privacy protections more stringent than HIPAA and data
security requirements applicable to information beyond health care information (for example, the California Consumer Privacy Act of 2018
(the “CCPA”)). These state laws create an additional level of enforcement and may require additional reporting in the event
of breach. Most of the health care providers in the United States with whom we collaborate to develop and test our products must comply
with HIPAA and applicable state law. We may not be directly subject to these laws, however, we must structure our activities in compliance
with these laws to ensure that we can access and use health information to support our research, development and other activities. Our
failure to comply with these privacy and security laws or a breach of health information or personal data could prompt enforcement against
our health care provider partners, create third party liability for our company and/or cause significant financial or reputational harm
to our company.
Numerous other countries have, or are developing, laws governing
the collection, use and transmission of personal data as well. For example, the European Parliament and the Council of the European Union
adopted a comprehensive general data privacy framework called the General Data Protection Regulation ("GDPR"), which went into effect
in 2018 and implemented a broad data protection framework that expanded the scope of EU data protection law, and applies to entities located
inside and outside of the EU that process, or control the processing of, personal data relating to individuals located in the EU, including
clinical trial data. We also continue to see other jurisdictions proposing and enacting data localization laws. Evolving legal, contractual,
and other privacy and data protection obligations, could impose significant limitations, require changes to our business, or restrict
our collection, use, storage or processing of personal data, which may increase our compliance expenses and make our business more costly
or less efficient to conduct. In addition, any such changes could impact our ability to develop an adequate marketing strategy and pursue
our growth strategy effectively, or even prevent us from providing our products in jurisdictions in which we receive marketing authorization,
or potentially cause us to incur liability in an effort to comply, which, in turn, could adversely affect our business, financial condition,
results of operations and prospects. Complying with these numerous, complex and often evolving requirements is expensive and difficult,
and suspected and actual failure to comply, whether by us, our service providers, CROs, business partners or other third parties, or any
inadvertent or unauthorized access to or use or disclosure of data that we store or handle as part of operating our business, could adversely
affect our business, financial condition, results of operations and prospects.
73
Innovation
Authority
We have received royalty-bearing grants from the IIA, for
the financing of a portion of our research and development expenditures in Israel.
Under the Innovation Law and the IIA’s rules and guidelines,
recipients of grants, or Recipient Company(ies), are subject to certain obligations and restrictions with respect to the use of their
IIA Funded Know-How, including, the following:
| • |
Royalty Payment Obligation. In general, the Recipient Company may be obligated to pay the
IIA royalties from any income deriving from the products (and related know-how and services), whether received by the grant recipient
or any affiliated entity, developed (in all or in part), directly or indirectly, as a result of, an Approved Program, or deriving therefrom,
at rates which are determined under the IIA’s rules and guidelines (currently a yearly rate of between 3% to 5% on sales of products
or services developed under the Approved Programs, depending on the type of the Recipient Company — i.e., whether it
is a “Small Company,” or a “Large Company” as such terms are defined in the IIA’s rules and guidelines),
up to the aggregate amount of the total grants received by the IIA, plus Annual Interest for a File (as such term is defined in the IIA’s
rules and guidelines). |
| • |
Reporting Obligations. The Recipient Company is subject to certain reporting obligations (such
as, periodic reports regarding the progress of the research and development activities under the Approved Program and the related research
expenses, and regarding the scope of sales of the Recipient Company’s products). In addition, any direct change in control of a
Recipient Company must be notified to the IIA. In the event that a non-Israeli entity or a non-Israeli citizen or resident person becomes
an “Interested Party” (as such term is defined in the Israeli Securities Law, 5728-1968) in the Recipient Company, notification
to the IIA is required, accompanied by a written undertaking (in the form available on the IIA's website) by such party to be bound by
the Innovation Law and by the terms of the Approved Program. |
| • |
Local Manufacturing Obligation. Products developed using the IIA grants must, as a general
matter, be manufactured in Israel. The transfer of manufacturing capacity outside of Israel in a manner that exceeds the manufacturing
capacity that was declared in the Recipient Company's original IIA grant application is subject to prior written approval from the IIA
(except for the transfer of less than 10% of the manufacturing capacity in the aggregate, which event requires only a notice to the IIA,
which shall be provided in writing prior to the transfer of such manufacturing rights abroad, while the IIA has a right to deny such transfer
within 30 days following the receipt of such notice). In general, the transfer of manufacturing capacity outside of Israel may be subject
an increase in the royalties' cap (inter alia, depending on the manufacturing volume that is performed
outside of Israel) and such transfer will be subject to payment of royalties in accelerated rate. |
| • |
IIA Funded Know-How transfer limitation. Under
the IIA’s rules and guidelines, a Recipient Company is prohibited from transferring the IIA Funded Know-How outside of Israel except
with the approval of the Research Committee and in certain circumstances, subject to certain payments to the IIA calculated according
to formulas provided under the IIA’s rules and guidelines (which are capped to amounts specified under such rules and guidelines,
generally up to 6 time the grants received plus Annual Interest as such term is defined under the rules, or A Redemption Fee). For
calculating the Redemption Fee which shall be paid to the IIA in the event of a transfer of IIA Funded Know-How outside of Israel, inter
alia, the following factors will be taken into account: the scope of the IIA support received, the royalties that have already paid to
the IIA, the amount of time that has lapsed since the Recipient Company has finalized the IIA Approved Program, the sale price and the
form of transaction. A transfer for the purpose of the Innovation Law and the IIA’s rules means an actual sale of the IIA-Funded
Know-How, or any other transaction which in essence constitutes a transfer of such know-how (such as providing an exclusive license to
a foreign entity for R&D purposes, which precludes the Recipient Company from further using such IIA Funded Know-How). A mere license
solely to market products resulting from the IIA Funded Know-How would not be deemed a transfer for the purpose of the Innovation Law
and the IIA’s rules. Upon payment of the Redemption Fee, the IIA Funded Know-How and the manufacturing rights of the products developed
using such IIA funding cease to be subject to the Innovation Law and the IIA’s rules. |
| • |
Subject to the IIA’s prior approval, a Recipient Company may transfer IIA Funded Know-How to another Israeli company, provided
that the acquiring company assumes all of the Recipient Company’s responsibilities towards the IIA. Such transfer will not be subject
to the payment of the Redemption Fee; however, the income from such transaction will generally be subject to the obligation to pay royalties
to the IIA (other than in specific circumstances that will be examined by the IIA, mainly when the transfer is between related entities).
|
| • |
IIA Funded Know-How license limitation. The grant
to a foreign entity of a right to use the IIA Funded Know-How for R&D purposes (which does not entirely prevent the Recipient Company
from using the Funded Know-How) is subject to receipt of the IIA’s prior approval. This approval is subject to payment to the IIA
in accordance with the formulas stipulated in the IIA's rules (which distinguish between the manner of the payment for such license grant,
i.e., one-time payment or payment in installments) and such payment shall be no less than the amount of the IIA grants received (plus
Annual Interest), and no more than the cap stated in the IIA’s rules and will generally be due only upon the receipt of the license
fee from the licensee. |
| • |
Imposition of Liens over IIA Funded Know-How. The Recipient Company is required to receive
an IIA approval for every transaction involving the grant of liens over IIA Funded Know-How (i.e., for both the imposing and the realization
of the liens). This obligation refers to fixed charges as well as to floating charges. In addition, to the extent that the transaction
involves a foreign pledgee, the pledgee must execute an undertaking (in the form available on the IIA's website) to comply with the Innovation
Law in the event of realization of the lien. |
74
The IIA’s rules also include a mechanism with respect
to the grant of a license by a Recipient Company (which is part of a multinational corporation) to its group entities to use its IIA Funded
Know-How. Such license is subject to the IIA’s prior approval and to the payment of 5% royalties from the income deriving from such
license, with the cap of the royalties increasing to 150% of the grant amount. Such mechanism includes certain requirements which must
be met in order to be able to enjoy such lower royalty payment.
We have received grants from the IIA in connection with our research
and development of a peripheral line of product candidates, which forms a negligible part of our activities, and therefore, we are subject
to the aforementioned restrictions with respect to such product candidates. The obligation to comply with the Innovation Law and the IIA's
rules (including with respect to the restriction of the transfer of IIA Funded Know-How and manufacturing rights outside of Israel) remains
in effect even after full repayment of all amounts payable to the IIA. Once a Redemption Fee is paid on a transfer of IIA Funded Know-How
outside Israel, all obligations towards the IIA (including the royalty obligation) cease.
The government of Israel does not own intellectual property rights
in technology developed with IIA funding and the IIA’s approval is not required for the export of any products resulting from the
IIA research or development grants.
Environmental, Health and Safety Matters
We are subject to extensive environmental, health and safety laws
and regulations in a number of jurisdictions including Israel. These laws and regulations govern, among other things, (i) the use, storage,
registration, handling, emission and disposal of chemicals, waste materials and sewage and (ii) chemical, air, water and ground contamination,
air emissions and the cleanup of contaminated sites, including any contamination that results from spills due to our failure to properly
dispose of chemicals, waste materials and sewage. Our operations at our Ness Ziona facility use chemicals and produce waste materials
and sewage. Our activities require permits from various governmental authorities, including local municipal authorities, the Ministry
of Environmental Protection and the Ministry of Health. The Ministry of Environmental Protection and the Ministry of Health, local authorities
and the municipal water and sewage company conduct periodic inspections in order to review and ensure our compliance with the various
regulations. Our business permit is currently in effect until December 31, 2026.
These laws, regulations and permits could potentially require the
expenditure by us of significant amounts for compliance or remediation. If we fail to comply with such laws, regulations or permits, we
may be subject to fines and other civil, administrative or criminal sanctions, including the revocation of permits and licenses necessary
to continue our business activities. In addition, we may be required to pay damages or civil judgments in respect of third-party claims,
including those relating to personal injury (including exposure to hazardous substances we use, store, handle, transport, manufacture
or dispose of), property damage or contribution claims. Some environmental, health and safety laws allow for strict, joint and several
liability for remediation costs, regardless of comparative fault. We may be identified as a responsible party under such laws. Such developments
could have a material adverse effect on our business, financial condition and results of operations.
In addition, laws and regulations relating to environmental, health
and safety matters are often subject to change. In the event of any changes or new laws or regulations, we could be subject to new compliance
measures or to penalties for activities which were previously permitted.
The operations of our subcontractors and suppliers are also subject
to various Israeli and foreign laws and regulations relating to environmental, health and safety matters, and their failure to comply
with such laws and regulations could have a material adverse effect on our business and reputation, result in an interruption or delay
in the development or manufacture of our product candidates, or increase the costs for the development or manufacture of our product candidates.
Properties
Our principal executive offices are located in a leased facility
in Weizmann Science Park, Ness Ziona 7403650, Israel. The facility is 1534 square meters, and houses our offices, warehouse, laboratories
and production area. Our lease will expire on December 31, 2025, with an option to extend the agreement for another two years.
Legal Proceedings
We are not subject to any material legal proceedings.
C.
Organizational Structure
Not applicable.
D. Property, Plant
and Equipment
See “Item 4. Information on the Company—B. Business
Overview—Properties”.
75
ITEM 4A. UNRESOLVED
STAFF COMMENTS
None.
ITEM 5. OPERATING
AND FINANCIAL REVIEW AND PROSPECTS
You should read the following discussion of our financial
condition and results of operations in conjunction with the consolidated financial statements
and the notes thereto included elsewhere in this annual report. The following discussion contains forward-looking statements
that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking
statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this annual
report, particularly those in “Item 3. Key Information – D.
Risk Factors.”
Overview
We are an innovative dermatology company with a successful track
record of two NDA approvals and advanced orphan drugs pipeline. We successfully developed pioneer topical drugs Twyneo and Epsolay, respectively
approved for the treatments of acne and inflammatory lesions of rosacea. From 2022 until April 2025, both products were marketed in the
United States by our U.S. commercial partner, Galderma. In April 2025, we sold our rights related to Twyneo and Epsolay in the U.S. to
Mayne, following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. for both products.
In terms of our proprietary assets in development, we are developing topical patidegib (SGT-610) for the prevention of BCC in Gorlin syndrome
patients, and topical erlotinib (SGT-210) for the treatment of rare Darier Disease and other rare keratosis-related indications.
We are developing the new chemical entity SGT-610 (Patidegib Topical
Gel 2%), a hedgehog signaling pathway blocker, for the chronic use and prevention of new BCC in Gorlin syndrome patients. Gorlin syndrome
is a rare disease with no therapies approved by the FDA or the EC for this disease. SGT-610 is aimed to prevent new BCCs in adults with
Gorlin syndrome without systemic adverse events. We believe it has the potential to be the first drug approved for the treatment of Gorlin
syndrome patients. SGT-610 has been granted Orphan Drug Designation by the FDA and the EC as well as Breakthrough Designation by the FDA.
If approved by the FDA, SGT-610 has the potential to generate, at peak, annual net sales in excess of $300 million (based on good faith
estimates derived from our knowledge and based in part on independent sources). Although we believe such data and estimate to be reliable,
it involves a number of assumptions and limitations, including without limitations the number of patients, the penetration level of the
treatment, and the expected treatment annual price.
Gorlin syndrome is a rare disease with no therapies currently approved
by the FDA or the EC for this disease. Gorlin syndrome affects approximately 1 in 31,000 people and is an autosomal dominant genetic
disorder, mostly caused by inheritance of one defective copy of the tumor suppressor gene PTCH1. The PTCH1 gene blocks the SMO gene, turning
off the hedgehog signaling pathway when it is not needed. However, mutations in PTCH1 may cause loss of PTCH1 function, release
of SMO, and may allow BCC tumor cells to divide uncontrollably. Gorlin syndrome is also called nevoid BCC syndrome because approximately
90% of individuals with this syndrome develop multiple BCCs, ranging from a few to many thousands of lesions during a patient’s
lifetime. Gorlin syndrome patients are also susceptible to many abnormalities, including, most frequently, palmar and plantar pits and
jaw cysts, and, most devastatingly, medulloblastomas.
On November 30, 2023, we announced that we have begun screening
patients for our Phase 3 study. In the patidegib’s seller, PellePharm study the SGT-610 arm was found to be as tolerable as the
vehicle and the significant adverse events commonly seen with oral hedgehog inhibitors were not observed. Our clinical study includes
essential modifications to the former Phase 3 study conducted by PellePharm. We have refined screening criteria in order to enroll subjects
with more severe disease at baseline reflected in a higher baseline number of facial BCC lesions. This refinement may help to better demonstrate
the preventive effect of our medication candidate. We are also pre-screening patients for a specific genetic mutation associated with
Gorlin syndrome that is considered relevant for HH inhibitors. In an effort to increase patient study compliance we reduced the number
of study visits over the 12 months of treatment. We plan to conduct the Phase 3 study to investigate SGT-610 in approximately 140
subjects at approximately 40 experienced clinical centers in North America, United Kingdom and Europe To date, we
have signed agreements with 43 centers in multiple countries, including the U.S., Spain, The Netherlands, Germany, Italy, France
and the UK, all of these centers have been activated and 80% of the trial subjects have been recruited. We currently expect results of
our Phase 3 study in the fourth quarter half of 2026.
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The rights to SGT-610 were purchased on January 30, 2023, pursuant
to an asset purchase agreement with PellePharm, dated January 23, 2023.
Our other product candidate is SGT-210 that we are developing for
the treatment of Darier Disease and other rare keratinization disorders, such as Pachyonychia Congenita (PC), Palmoplantar keratodermas
(PPK), and Olmsted Syndrome (OS), a group of skin conditions characterized by thickening of the skin, among others. We initiated a phase
1 clinical trial for Darier Disease in March 2024. In addition, we have been using SGT-210 in a compassionate use treatment for a pediatric
patient suffering from an ultra-rare disease.
Twyneo, is a once-daily, non-antibiotic topical cream, containing
a fixed-dose combination of encapsulated benzoyl peroxide, or E-BPO, and encapsulated tretinoin for the treatment of acne. Acne is one
of the three most prevalent skin diseases in the world and is the most commonly treated skin disease in the United States. According to
the American Academy of Dermatology, acne affects approximately 40 to 50 million people in the United States, of which approximately 10%
are treated with prescription medications. Tretinoin and benzoyl peroxide, the two active components in Twyneo, are both widely-used therapies
for the treatment of acne that historically have not been conveniently co-administered due to stability concerns. Twyneo was approved
for marketing by the FDA in July 2021 in the United States and was licensed to Galderma exclusively in the United States in June 2021
until April 2025, when we sold our rights related to Twyneo and Epsolay in the U.S. to Mayne, following the mutual termination by Sol-Gel
and Galderma of the exclusive five-year license agreement in the U.S. for both products.
Epsolay, is a once-daily topical cream containing 5% encapsulated
benzoyl peroxide, that we have developed for the treatment of inflammatory lesions of rosacea in adults. Rosacea is a chronic skin disease
characterized by facial redness, inflammatory lesions, burning and stinging. According to the U.S. National Rosacea Society, approximately
16 million people in the United States are affected by rosacea. According to a study we commissioned in 2017, approximately 4.8 million
people in the United States experience subtype II symptoms. Subtype II rosacea is characterized by small, dome-shaped erythematous papules,
tiny surmounting pustules on the central aspects of the face, solid facial erythema and edema, and thickening/overgrowth of skin. Subtype
II rosacea resembles acne, except that comedowns are absent, and patients may report associated burning and stinging sensations. Current
topical therapies for subtype II rosacea are limited due to tolerability concerns. For example, BPO, a common therapy for acne, is not
used for the treatment of subtype II rosacea due to side effects. As encapsulated BPO, Epsolay is designed to redefine the standard of
care for the treatment of subtype II rosacea. Epsolay, is the first product containing BPO that is marketed for the treatment of
subtype II rosacea. Epsolay was approved for marketing by the FDA in April 2022 and was licensed to Galderma exclusively in the United
States in June 2021 until April 2025, when we sold our rights related to Twyneo and Epsolay in the U.S. to Mayne, following the mutual
termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. for both products.
In January 2023, we entered into an asset purchase agreement
with PellePharm, pursuant to which we purchased the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment
of Gorlin syndrome. Under the terms of the agreement upon closing of the transaction, the Company paid an upfront payment of $4 million
to PellePharm, and the remaining principal amount outstanding of $0.7 million has not been transferred as of the date of this report.
We are also required to pay:
| • |
up to $6 million in total development and NDA acceptance milestone payments; |
| • |
up to $64 million in commercial milestone payments, which amount increases to $89 million when sales exceed $500 million; and
|
| • |
single digit royalties, which increase to double digit royalties when sales exceed $500 million. |
In June 2021, we entered into two five-year exclusive license
agreements with Galderma pursuant to which Galderma has the exclusive right to, and is responsible for, all U.S. commercial activities
for Twyneo and Epsolay. Pursuant to the agreement, we received $11 million in upfront payments to and regulatory approval milestone
payments. We are also eligible to receive tiered double-digit royalties ranging from mid-teen to high-teen percentage of net sales as
well as up to $9 million in sales milestone payments. We also expect to collaborate with third parties that have sales and
marketing experience in order to commercialize Epsolay and Twyneo outside of the United States and our product candidates, if approved
by the FDA for commercial sale, in lieu of our own sales force and distribution systems. In other markets, we also expect to selectively
pursue strategic collaborations with third parties in order to maximize the commercial potential of our product candidates. In April 2025,
we sold our rights related to Twyneo and Epsolay in the U.S. to Mayne, following the mutual termination by Sol-Gel and Galderma of the
exclusive five-year license agreement in the U.S. for both products.
In June 2023, we entered into exclusive license agreements with
Searchlight pursuant to which the agreements, Searchlight has the exclusive right, and is responsible for, all commercial activities for
Twyneo and Epsolay in Canada, over a fifteen-year term that is renewable for subsequent five-year periods. Searchlight will be responsible
for obtaining and maintaining ay regulatory approvals required to market and sell the drugs in Canada with support from us. In consideration
for the grant of such rights, we will receive up to $11 million in potential upfront payments and regulatory and sales milestones for
both drugs, combined. In addition, we will be entitled to royalty percentages of all Canadian net sales ranging from low-double-digits
to high teens.
77
In May 2024, we entered into an asset purchase agreement with
Beimei Pharma, pursuant to which Beimei purchases and licenses the rights to commercialize and manufacture Twyneo in China, Hong Kong,
Macau, Taiwan and Israel. We expect to receive, subject to applicable government approvals, a total consideration of up to $15 million,
out of which $10 million will be paid as upfront and regulatory milestones, and the remaining $5 million will be paid as royalties on
net sales.
During 2024, we also entered into commercialization agreements
for commercialization of Twyneo and Epsolay in most European countries, South Africa and South Korea.
In November 2021, we announced that we had signed an agreement
with Padagis, pursuant to which we sold our rights related to 10 generic collaborative programs and retained the collaboration rights
to two generic programs. Under the terms of the agreement with Padagis, effective as of November 2021, we received $21.5 million over
24 months, in lieu of our share in ten generic programs, two of which were approved by the FDA, and eight of which are unapproved.
Pursuant to the agreement, effective as of November 1, 2021, we ceased paying any outstanding and future operational costs related to
those collaborative programs, the rights of which were sold to Padagis. Following the agreement, we had one remaining active
collaboration agreement with Padagis for the development, manufacturing and commercialization of a generic drug product to Zoryve® Cream
(roflumilast cream 0.3%). On August 15, 2024, we signed a new agreement with Padagis, which replaced the parties’ prior collaboration
agreement for the development and commercialization of such generic drug product. Under this new agreement, we are to unconditionally
receive eight quarterly payments which will be paid over 24 months and low single digit royalties from gross profits from sales of
roflumilast cream for a period of five years, in lieu of our share in future gross profits from such sales. In addition, Sol-Gel ceased
paying any outstanding and future costs related to this prior collaboration agreement. The amount to be received from Padagis, together
with the elimination of future expected expenses related to this asset, is expected to enhance our cash position by approximately $6 million.
Since our inception, we have incurred significant operating losses.
We incurred net losses of $14.9 million, $27.2 million and $10.6 million, for the years ended December 31, 2022, December 31, 2023 and
December 31, 2024, respectively. As of December 31, 2024, we had an accumulated deficit of $230.9 million. We expect to incur significant
expenses and operating losses for the foreseeable future as we advance our product candidates from formulation development through pre-clinical
development and clinical trials, seek regulatory approval and pursue commercialization of any approved product candidate. In addition,
we may incur expenses in connection with the in-license or acquisition of additional product candidates.
Recent Developments
On April 1, 2025, our shareholders approved a reverse share split
of all of our outstanding ordinary shares at a ratio of between 2:1 and 10:1 at a special meeting of shareholders. On April 9, 2025, the
Board of Directors approved a 1-for-10 reverse share split of our ordinary shares, which is expected to become effective at 11:59 p.m.
Eastern Time on Friday, May 2, 2025. In conjunction with the reverse share split, pursuant to the amended articles of association, the
par value of the Company’s ordinary shares will be adjusted from 0.1 NIS per share to 1.0 NIS per share, and the share capital will
be adjusted from 50,000,000 to 5,000,000 ordinary shares. All references made to share or per share amounts in the consolidated financial
statements and applicable disclosures herein, unless otherwise indicated, are presented on a pre-split basis.
A. Operating Results
Collaboration Revenues
During the years ended December 31, 2022, 2023 and 2024, we recognized
revenues from royalties and milestone payment related to our collaboration agreements with Galderma and Searchlight in the amount of $3.9
million, $1.6 million, and $2.2 million, respectively.
Operating expenses
Our current operating expenses consist primarily of research and
development as well as general and administrative expenses.
Research and development expenses
Research and development expenses consist principally of:
| • |
salaries for research and development staff and related expenses, including employee benefits and share-based compensation expenses;
|
| • |
expenses paid to suppliers of disposables and raw materials, including drug substances, and related expenses, such as, external laboratory
testing and development of analytical methods; |
| • |
expenses for commercialization of Epsolay and Twyneo in other territories; |
78
| • |
expenses paid to contract research organizations and other third parties in connection with the performance of pre-clinical studies,
clinical trials and related expenses; |
| • |
expenses incurred under agreements with other third parties, including subcontractors, suppliers and consultants that conduct formulation
development, regulatory activities and pre-clinical studies; |
| • |
expenses incurred to acquire, develop and manufacture materials for use in pre-clinical and other studies; |
| • |
expenses incurred from the purchase and transfer of product candidates; and |
| • |
facilities, depreciation of fixed assets used to develop our product candidates, maintenance of equipment used to develop our product
candidates and other expenses, including direct and allocated expenses for rent, maintenance of facilities, insurance and other operating
expenses. |
Research and development activities are central to our business
model. Product candidates in later stages of clinical development generally have higher development expenses than those in earlier stages
of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect to continue to incur
research and development expenses over the next several years as we conduct pre-clinical studies and clinical trials and prepare regulatory
filings for our product candidates.
Due to the inherently unpredictable and highly uncertain nature
of clinical development processes, we cannot reasonably estimate the nature, timing and expenses of the efforts that will be necessary
to complete the remainder of the development of our product candidates, or when, if ever, material net cash inflows may commence from
any of our product candidates. Clinical development timelines, the probability of success and development expenses can differ materially
from expectations. This is due to numerous risks and uncertainties associated with developing drugs, including the uncertainty of:
| • |
the scope, rate of progress and expense of our research and development activities; |
| • |
clinical trials and early-stage results; |
| • |
the terms and timing of regulatory requirements and approvals; |
| • |
the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights; and |
| • |
the ability to market, commercialize and achieve market acceptance of any product candidate that we are developing or may develop
in the future. |
While we are currently focused on advancing our product development,
our future research and development expenses will depend on the clinical success of our product candidates, as well as ongoing assessments
of the product candidates’ commercial potential. As we obtain results from clinical trials, we or our partners may elect to discontinue
or delay clinical trials for one or more of our product candidates in certain indications in order to focus our resources on more promising
product candidates. Completion of clinical trials may take several years or more, but the length of time generally varies according to
the type, complexity, novelty and intended use of a product candidate.
The lengthy process of completing clinical trials and seeking regulatory
approval for our product candidates requires the expenditure of substantial resources. Any failure or delay in completing clinical trials,
or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses
to increase and, in turn, have a material adverse effect on our operations.
General and administrative expenses
Our general and administrative expenses consist primarily of salaries
and related expenses, including employee benefits and share-based compensation expenses, legal expenses and professional fees for auditors
and other expenses not related to research and development activities.
79
Financial income, net
Our financial income, net consists primarily of income generated
on our marketable securities and bank deposits net of expenses related to bank charges and foreign currency exchange transactions.
Results of operations
The following table summarizes our results of operations for the
indicated periods:
|
|
Year ended December 31, |
|||||||||||
|
|
2022 |
2023 |
2024 |
|||||||||
|
|
(in thousands) |
|||||||||||
|
|
||||||||||||
|
Revenues |
$ |
3,883 |
$ |
1,554 |
$ |
11,538 |
||||||
|
Research and development |
12,682 |
23,541 |
17,803 |
|||||||||
|
General and administrative |
7,445 |
7,373 |
5,749 |
|||||||||
|
Other income, net |
- |
55 |
- |
|||||||||
|
Total operating loss |
(16,244 |
) |
(29,305 |
) |
(12,014 |
) | ||||||
|
Financial income, net |
1,321 |
2,067 |
1,434 |
|||||||||
|
Loss before income taxes |
(14,923 |
) |
(27,238 |
) |
(10,580 |
) | ||||||
|
Loss for the year |
$ |
(14,923 |
) |
$ |
(27,238 |
) |
$ |
(10,580 |
) | |||
Year ended December 31, 2023 compared to year ended December 31, 2024
Revenues
We generated a total of $11.6 million in revenues in 2024,
mainly related to the license agreements with Galderma, Beimei, Padagis and Searchlight comprised of milestone and royalty payments, compared
with $1.6 million total revenues in 2023. The increase in revenues in 2024 resulted mainly from milestone payments from Beimei and
Padagis agreements.
Research and development expenses
The following table describes the breakdown of our research and development expenses
for the indicated periods:
|
|
Year Ended December 31, |
|||||||
|
|
2023 |
2024 |
||||||
|
|
(in thousands) |
|||||||
|
|
||||||||
|
Payroll and related expenses |
$ |
5,650 |
$ |
3,592 |
||||
|
Clinical and preclinical trials expenses |
5,745 |
8,280 |
||||||
|
Professional consulting and subcontracted work |
10,134 |
4,647 |
||||||
|
Other |
2,012 |
1,284 |
||||||
|
Total research and development expenses |
$ |
23,541 |
$ |
17,803 |
||||
Our research and development expenses were $23.5 million for the year ended December
31, 2023 compared to $17.8 million for the year ended December 31, 2024. The decrease of $5.7 million was primarily attributed to a decrease
of $2.8 million related to clinical expenses for a generic product candidate, a decrease of $2.1 million in payroll expenses due to the
adoption of cost saving measures initiated during the third quarter of 2023, a decrease of $1.5 million in professional expenses and a
decrease of $0.6 million in operational expenses, offset by an increase of $1.1 million related to the commercialization of Epsolay and
Twyneo in other territories and an increase of $0.2 million in clinical trial expenses related to SGT-610.
80
General and administrative expenses
Our general and administrative expenses were $7.4 million for the
year ended December 31, 2023, compared to $5.8 million for the year ended December 31, 2024. The decrease of $1.6 million was primarily
attributed to a decrease of $1 million in payroll expenses due to the adoption of cost saving measures initiated during the third quarter
of 2023 and a decrease of $0.6 million in professional services.
Financial income, net
Our financial income, net, was $2.1 million for the year ended
December 31, 2023 compared to $1.4 million for the year ended December 31, 2024. The decrease of $0.7 million was primarily attributed
to a decrease of interest income from deposits and marketable securities.
Year ended December 31, 2022 compared to year ended December 31, 2023
This analysis can be found in Item 5 of the Company’s
Annual Report on Form 20‑F for the year ended December 31, 2023.
JOBS Act
On April 5, 2012, the JOBS Act was signed into law. Subject
to certain conditions set forth in the JOBS Act, an “emerging growth company,” may elect to rely on certain exemptions, including
without limitation, not (i) providing an auditor’s attestation report on our system of internal controls over financial reporting
pursuant to Section 404 and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding
mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial
statements (auditor discussion and analysis). Although we have ceased to be an “emerging growth company” and accordingly we
are no longer exempt from the requirement to comply with any requirement that may be adopted by the Public Company Accounting Oversight
Board regarding supplement to the auditor’s report providing additional information about the audit and the financial statements.
We are currently exempt from the requirement to provide an auditor’s attestation report on our system of internal controls over
financial reporting pursuant to Section 404.
B. Liquidity and Capital
Resources
Overview
Since our inception, we have devoted substantially all of our resources
to developing Twyneo, Epsolay, SGT-610, and our product candidates, building our intellectual property portfolio, developing our supply
chain, business planning, raising capital and providing for general and administrative support for these operations. Other than Twyneo
and Epsolay, we do not currently have any approved products.
From inception through December 31, 2024, we have funded our operations
primarily through proceeds from our public offerings, the issuance of equity securities to, and loans and investments from, our controlling
shareholder, funding received from the IIA and from amounts received pursuant to past and current collaboration agreements. As of
December 31, 2024, our cash and cash equivalents, bank deposits and marketable securities were $23.9 million.
On January 27, 2023, we entered into a securities purchase agreement
with Armistice Capital pursuant to which we issued to Armistice Capital (i) 2,560,000 ordinary shares in a registered direct offering
at a price of $5.00 per ordinary share and (ii) in a concurrent private placement unregistered warrants to purchase up to 2,560,000
ordinary shares at an exercise price of $5.85 per share. Concurrently with the signing of the purchase agreement, we also entered
into a subscription agreement with Arkin Dermatology Ltd., pursuant to which Arkin Dermatology Ltd. purchased 2,000,000 unregistered ordinary
shares and unregistered warrants to purchase up to 2,000,000 ordinary shares in a concurrent private placement exempt from the registration
of the Securities Act, at a price equal to the offering price of the ordinary shares in the offering. The aggregate gross proceeds to
the Company from these transactions were approximately $22.8 million.
81
The
table below summarizes our cash flow activities for the indicated periods:
|
|
Year Ended
December 31, |
|||||||||||
|
|
2022 |
2023 |
2024 |
|||||||||
|
(in thousands) |
||||||||||||
|
|
||||||||||||
|
Net cash used in operating activities
|
$ |
$ |
(17,730 |
) |
$ |
(13,889 |
) | |||||
|
Net cash provided by (used in) investing activities
|
(9,742 |
) |
26,692 |
|||||||||
|
Net cash provided by financing activities
|
21,810 |
- |
||||||||||
|
Effect of exchange rates on cash and cash equivalents |
(73 |
) |
(1 |
) | ||||||||
|
Increase (decrease) in cash and cash equivalents |
$ |
$ |
(5,735 |
) |
$ |
12,802 |
||||||
Operating Activities
Net cash used in operating activities was $17.7 million during
the year ended December 31, 2023 compared to $13.9 million during the year ended December 31, 2024.
Net cash used in operating activities in the year ended December
31, 2023 primarily resulted from our loss of $27.2 million during the period, net of $7.7 million of net changes in working capital
and non-cash expenses of $1.9 million share-based compensation expenses and $0.3 million of depreciation of property and equipment.
Net cash used in operating activities in the year ended December
31, 2024, primarily resulted from our net loss of $10.6 million during the period, net of $4.4 million of net changes in working
capital and non-cash expenses of $0.8 million share-based compensation expenses and $0.2 million of depreciation of property and equipment.
Investing Activities
Net cash provided by investing activities was $9.7 million during
the year ended December 31, 2023, compared to net cash provided by investing activities of $26.7 million during the year ended December
31, 2024. The 2023 net cash provided by investing activities resulted mainly from $23.2 million investments in marketable securities,
net of $11.8 million proceeds from sale and maturity of marketable securities, offset by proceeds from bank deposits of $1.7 million.
The 2024 net cash provided by investing activities resulted mainly from $15.9 million proceeds from sale and maturity of marketable
securities, and by proceeds from bank deposits of $10 million.
Financing Activities
Net cash from financing activities was $21.8 million during the
year ended December 31, 2023, compared to $0 million during the year ended December 31, 2024, mainly from issuance of shares and warrants
through the public offering and private placement from the controlling shareholder, net of issuance costs in the year ended December 31,
2023.
82
Funding Requirements
Our primary uses of cash have been to fund working capital requirements and research
and development. We expect to continue to incur net losses for the foreseeable future as we continue to invest in research and development
and seek to obtain regulatory approval for and commercialize our product candidates. We believe that our existing cash, cash equivalents,
deposits and marketable securities (including the amounts to be received from the transaction with Mayne), will be sufficient to enable
us to fund our operating expenses and capital expenditure requirements for at least 12 months from the filing date of this annual report.
We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently
expect.
Developing drugs, conducting clinical trials, obtaining commercial
manufacturing capabilities and commercializing products is expensive and we will need to raise substantial additional funds to achieve
our strategic objectives. We will require significant additional financing in the future to fund our operations, including if and when
we progress into additional clinical trials for our product candidates, obtain regulatory approval for one or more of our product candidates,
obtain commercial manufacturing capabilities and commercialize one or more of our product candidates. Our future funding requirements
will depend on many factors, including, but not limited to:
| • |
the progress and expenses of our pre-clinical studies, clinical trials and other research and development activities; |
| • |
the scope, prioritization and number of our clinical trials and other research and development programs; |
| • |
the expenses and timing of obtaining regulatory approval, if any, for our product candidates; |
| • |
the expenses of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights; and |
| • |
the expenses of, and timing for, expanding our manufacturing agreements for production of sufficient clinical and commercial quantities
of our product candidates. |
Other than revenue that we expect to generate from the commercialization
of Twyneo and Epsolay, until we can generate recurring revenues, we expect to satisfy our future cash needs through existing cash resources,
additional debt or equity financings or by entering into collaborations with third parties in connection with our products. We cannot
be certain that additional funding will be available to us on acceptable terms, if at all. In addition, the terms of any securities we
issue in future financings may be more favorable to new investors and may include preferences, superior voting rights and the issuance
of warrants or other derivative securities, which may have a further dilutive effect on the holders of any of our securities then outstanding.
If we raise additional funds through collaborations with third parties, we may be required to relinquish valuable rights to our technologies,
future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are
unable to obtain adequate funds on reasonable terms, we will need to curtail operations significantly, including possibly postponing anticipated
clinical trials or entering into financing agreements with unattractive terms.
C. Research
and Development, Patents and Licenses
For a description of our research and development programs and
the amounts that we have incurred over the last two years pursuant to those programs, please see “Item 5. Operating and Financial
Review and Prospects — A. Operating Results — Research and Development Expenses”; and “Item 5. Operating and Financial
Review and Prospects — A. Operating Results — Year Ended December 31, 2023 compared to Year ended December 31, 2024 - Research
and Development Expenses.”
83
D. Trend
Information
Other than as disclosed elsewhere in this annual report, we are
not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 2024 to December 31, 2024 that are
reasonably likely to have a material adverse effect on our revenue, income, profitability, liquidity or capital resources, or that caused
that disclosed financial information to be not necessarily indicative of future operating results or financial condition.
E.
Critical Accounting Estimates
Significant Accounting Policies and Estimates
We prepare our consolidated financial statements in conformity
with U.S. GAAP. We describe our significant accounting policies and estimates more fully in Note 2 to our consolidated financial statements
as of and for the year ended December 31, 2024, included elsewhere in this annual report. We believe that the accounting policies
and estimates below are critical in order to fully understand and evaluate our financial condition and results of operations. In preparing
these consolidated financial statements, our management has made estimates and assumptions that affect the reported amounts of assets
and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts
of expenses during the reporting periods recognized in our financial statements. Actual results may differ from these estimates. As applicable
to the consolidated financial statements included in this annual report, the most significant estimates and assumptions relate to the
fair value of share-based compensation.
Share-based Compensation
Share-based compensation reflects the compensation expense of our
share option programs granted to employees which compensation expense is measured at the grant date fair value of the options. The grant
date fair value of share-based compensation is recognized as an expense over the requisite service period, net of estimated forfeitures.
We recognize compensation expense for awards conditioned only on continued service that have a graded vesting schedule using the accelerated
method based on the multiple-option award approach, and classify these amounts in our statement of operations based on the department
to which the related employee reports.
Options Valuation
We selected the Black-Scholes option pricing model as the most
appropriate method for determining the estimated fair value of the shared based compensation. For the purpose of the evaluation
of the fair value and the manner of the recognition of share-based compensation, our management is required to estimate, among others,
various subjective and complex parameters that are included in the calculation of the fair value of the option. The Company calculates
the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model. The option-pricing model
requires a number of assumptions, of which the most significant are the expected share price volatility and the expected option term.
The computation of expected volatility is based on historical volatility of the Company’s shares and of similar companies in the
healthcare sector. The expected option term is calculated using the simplified method, as the Company concludes that its historical share
option exercise experience does not provide a reasonable basis to estimate its expected option term. The interest rate for periods within
the expected term of the award is based on the U.S. Treasury yield curve in effect at the time of grant. The Company’s expected
dividend rate is zero since the Company does not currently pay cash dividends on its shares and does not anticipate doing so in the foreseeable
future. Each of the above factors requires the Company to use judgment and make estimates in determining the percentages and time periods
used for the calculation. If the Company were to use different percentages or time periods, the fair value of stock-based option awards
could be different. The fair values of the Company’s RSUs are measured based on the fair value of the Company’s ordinary shares
on the date of grant.
84
ITEM 6.
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A.
Directors and Senior Management
The following table sets forth information concerning our
directors and senior management, which includes members of our administrative, supervisory and management bodies, including their ages,
as of the date of this annual report:
|
Name |
|
Age |
|
Position |
|
|
|
|
|
|
|
|
|
Moshe Arkin |
|
72 |
|
Executive Chairman of the Board of Directors and interim Chief Executive Officer
|
|
|
Eyal Ben-Or |
|
42 |
|
Chief Financial Officer |
|
|
Ofer Toledano |
|
60 |
|
Vice President Research and Development |
|
|
Ofra Levy-Hacham |
|
59 |
|
Vice President Clinical, Regulatory Affairs and Quality |
|
|
Michael Glezin |
|
43 |
|
Chief Business Officer |
|
|
Itzik Yosef |
|
48 |
|
Chief Operating Officer |
|
|
Tamar Fishman Jutkowitz |
|
49 |
|
Vice President and General Counsel |
|
|
Itai Arkin |
|
36 |
|
Director |
|
|
Hanna Lerman |
|
52 |
|
Director |
|
|
Sharon G. Kochan |
|
56 |
|
Director |
|
|
Ran Gottfried |
|
80 |
|
Lead Independent Director |
|
|
Yuval Yanai |
|
72 |
|
Independent Director |
|
Mr. Moshe Arkin
has served as our interim chief executive officer since January 1, 2025 and has served as our chairman of our board of directors
since 2014. In May 2022, Mr. Moshe Arkin's role was expanded to Executive Chairman to reflect Mr. Arkin’s expanded role at the Company.
Mr. Moshe Arkin currently sits on the board of directors of several private pharmaceutical and medical device companies including SoniVie
Ltd., a company developing systems for the treatment of pulmonary arterial hypertension, Digma Medical, a company developing systems to
treat insulin resistance present in type 2 diabetes and other metabolic syndrome diseases, and Valcare Medical, a company developing heart
valve devices. From 2005 to 2008, Mr. Moshe Arkin served as the head of generics at Perrigo Company and from 2005 until 2011 as the vice
chairman of its board of directors. Prior to joining us, Mr. Moshe Arkin served as a director of cCAM Biotherapeutics Ltd., a company
focused on the discovery and development of novel immunotherapies to treat cancer from 2012 until its acquisition in 2015 by Merck &
Co., Inc. Mr. Moshe Arkin served as chairman of Agis Industries Ltd. from its inception in 1972 until its acquisition by Perrigo Company
in 2005. Mr. Moshe Arkin holds a B.A. in psychology from the Tel Aviv University, Israel.
Mr. Eyal Ben-Or
has served as our Chief Financial Officer since July 2024. Mr. Ben-Or joined Sol-Gel in 2017 and has served the organization as Director
of Finance and Corporate Controller. Prior to joining Sol-Gel, Mr. Ben-Or served in financial reporting roles at Mobileye N.V. (NYSE:
MBLY) and in several roles in the assurance department of KPMG. Mr. Ben-Or holds a master’s degree in business administration and
financial management and a bachelor’s degree in accounting and business administration from the College of Management in Israel
and is a certified public accountant.
Dr. Ofer Toledano
has served as our vice president of research and development since 2004. Prior to joining Sol-Gel, Dr. Toledano served as manager
of the formulation department at ADAMA Agricultural Solutions Ltd. (formerly known as Makhteshim Agan Industries Ltd.), an Israeli manufacturer
and distributor of crop protection products from 1998 until 2004. Dr. Toledano holds a Ph.D. in chemistry from The Hebrew University of
Jerusalem, Israel.
85
Dr. Ofra
Levy-Hacham has served as our vice president of quality, clinical and regulatory affairs since January 2024, as our vice president
of clinical and regulatory affairs since 2018, and as our vice president of quality and regulatory affairs from 2011 to 2018. Prior to
joining Sol-Gel, Dr. Levy-Hacham served as a scientific specialist and project manager at Biotechnology General Ltd., a wholly owned subsidiary
of Ferring Pharmaceuticals Ltd., and a fully integrated biopharmaceutical services private company from 2010 until 2011. From 2005 until
2010, Dr. Levy-Hacham served as vice president chemistry, manufacturing and controls at HealOr Ltd., a private company engaging in the
development of therapeutics for the treatment of various skin disorders. Dr. Levy-Hacham holds a Ph.D. in chemistry from The Technion
– Israel Institute of Technology, Israel.
Mr. Michael Glezin
has served as Chief Business Officer since January 2025, and as our vice president of business development from September 2022. Prior
to joining Sol-Gel Mr. Glezin served from 2011 to 2022 as the Head of Generic Business Development and in various other business development
positions at Dexcel Pharma, an international specialty pharmaceutical company. Mr. Glezin has over a decade of experience leading both
in-licensing and out-licensing deals in multiple territories such as Europe, the U.S. and Israel. Throughout his career, he has identified
technology transfer opportunities for both prescription and over-the-counter drug segments, as well as led numerous merger and acquisition
deals in Europe and surrounding areas. Mr. Glezin has an Executive MBA from Haifa University in Israel in partnership with Tongi University
in China. He has a BA from Haifa University in Economics and Management and he studied Accounting at Bar Ilan University.
Dr.
Itzik Yosef has served as Chief Operating Officer since 2020, and as our vice president of operations from 2016 until 2020. Since
joining us in 2010, Dr. Yosef held various positions including as head of operations. Dr. Yosef holds a Ph.D. in chemistry from The Hebrew
University of Jerusalem, Israel.
Adv. Tamar
Fishman Jutkowitz joined us as our vice president and general counsel in March 2023. From August 2015 to March 2023, Ms. Fishman
Jutkowitz worked at Gross & Co. Law Firm, where she was a partner from January 2018. From December 2011 to March 2015, Ms. Fishman
Jutkowitz served as general counsel of Compugen Ltd., a biotechnology company dual listed on Nasdaq and TASE. From February 2006 to December
2011, Ms. Fishman Juktowitz served as General Counsel of Rosetta Genomics Ltd., a biotechnology company listed on Nasdaq. Ms. Fishman
Jutkowitz holds a Master’s degree in business economics from Bar Ilan University and a L.L.B degree (cum laude) from Bar-Ilan University,
Israel.
Mr. Itai
Arkin became a member of our board of directors immediately following the pricing of our initial public offering. Mr. Itai Arkin
currently serves as Investment Manager at Arkin Holdings Ltd. Mr. Itai Arkin holds a B.A. in business administration (cum laude) from
Interdisciplinary Center, Herzliya, Israel, and an MBA (cum laude) from Tel Aviv University. Mr. Itai Arkin is the son of Mr. Moshe Arkin,
the chairman of our board of directors and sole beneficial owner of Arkin Dermatology, our controlling shareholder.
Ms. Hanna Lerman
became a member of our board of directors immediately following pricing of our initial public offering. Ms. Lerman has served as chief
financial officer at Arkin Holdings since 2015. From 2010 until 2014, Ms. Lerman served as chief financial officer of Sansa Security (f/k/a
Discretix Technologies), and from 2006 until 2010, she served as chief financial officer of Storwize, which was acquired by IBM in 2010.
She served as a board member of Exalenz Bioscience and of Sphera Global Healthcare. She holds a Master's degree in business administration
with a major in finance from Tel-Aviv University, Israel, and a B.A. in economics and accounting from Tel-Aviv University, Israel.
Mr. Sharon
G. Kochan became a member of our board of directors in June 2023. Mr. Kochan serves as Operating Director with SK Capital Partners
of NYC, board member of Apotex Inc. of Toronto, and Woodstock Sterile Solutions Inc. of Chicago since January 15th, 2024, as well as Director
with Top Gum Industries Ltd. (TASE). Prior to that, Mr. Kochan has served as President and CEO of Padagis LLC from its incorporation in
July 2021, when it was carved out of Perrigo Company Plc. ("Perrigo"), a global, over-the-counter, consumer goods and specialty pharmaceutical
company listed on the New York Stock Exchange, until February 2023. Prior to that, Mr. Kochan served as Executive Vice President &
President Pharmaceuticals from 2018 for Perrigo, President International, from 2012 until 2018, and President Prescription Pharmaceuticals
from 2007. From 2005 to 2007, Mr. Kochan served as Senior Vice President of Business Development and Strategy for Perrigo. Mr. Kochan
was Vice President, Business Development of Agis Industries (1983) Ltd. ("Agis") from 2001 until Perrigo acquired Agis in 2005. Mr. Kochan
has served as a board member of MediWound Ltd. from July 2017 to June 2023 and served as a board member of Exalenz BioScience Ltd. from
July 2016 to March 2020 when it was acquired by Meridian. Mr. Kochan completed the Senior Management Program at the Technion Institute
of Management in Haifa, Israel, received a Master of Science in Operations Research & Management Science from Columbia University
in New York City and received a Bachelor of Science in Industrial Engineering from Tel-Aviv University, Israel.
Mr. Ran
Gottfried became a member of our board of directors immediately following the pricing of our initial public offering and serves
as an external director under the Companies Law and as the lead independent director. Since 1975, Mr. Gottfried has served as a chief
executive officer, consultant and director of private companies in Israel and Europe in the areas of retail and distribution of pharmaceuticals,
consumer and household products. Mr. Gottfried served as a director of Perrigo Company from 2006 until 2015. From 2006 until 2008, Mr.
Gottfried served as chairman and chief executive officer of Powerpaper Ltd., a leading developer and manufacturer of micro electrical
cosmetic and pharmaceutical patches. From 2005 until 2010, Mr. Gottfried served as a director of Bezeq, Israel’s leading telecommunications
provider and from 2003 until its acquisition by Perrigo Company in 2005, Mr. Gottfried served as a director of Agis Industries Ltd. He
served as a director at Shufersal Ltd from 2018 until 2022.
86
Mr. Yuval Yanai became
a member of our board of directors in February 2024. Mr. Yanai currently
serves as a director in multiple companies, both public and private. He is currently a director and the Chairman of the Audit Committee,
Chairman of the Finance Committee and Chairman of the Compensation Committee of Check-Cap Ltd., a medical company traded on Nasdaq Stock
Market; an external director and Chairman of the Finance (Balance Sheet), Compensation and Audit Committee of Clal Biotechnology Industries,
an Israeli life sciences investment company traded on the Tel Aviv Stock Exchange; a director in S&P Global Ratings Maalot Ltd., a
finance rating company; and a director in PulseNmore Ltd., a medical device company traded on the Tel Aviv Stock Exchange. Mr. Yanai also
serves as a director at a number of private medical companies. From 2005 until 2014, Mr. Yanai served as CFO of Given Imaging Ltd.,
a medical company traded on Nasdaq Stock Market and on the Tel Aviv Stock Exchange, and from 2000 until 2005. Mr. Yanai served as Senior
Vice President and CFO of Koor Industries Ltd., an industrial holding company traded on the New York Stock Exchange and on the Tel Aviv
Stock Exchange. From 1998 until 2000, Mr. Yanai served as CFO of Nice Systems Ltd., a technology company traded on the Nasdaq Stock Market,
and from 1985 until 1998, Mr. Yanai served as CFO of Elscint Ltd., a technology company traded on the New York Stock Exchange. Mr. Yanai
holds a B.A. in accounting and finance from Tel-Aviv University, Israel.
B. Compensation
The aggregate compensation paid by us to our executive officers
and directors for the year ended December 31, 2024 was approximately $2.6 million. This amount includes approximately $0.4 million
set aside or accrued to provide pension, severance, retirement or similar benefits or expenses, but does not include business travel,
relocation, professional and business association dues and expenses reimbursed to officers, and other benefits commonly reimbursed or
paid by companies in Israel.
The table and summary below outline the compensation granted to
our five highest compensated directors and officers during the year ended December 31, 2024. The compensation detailed in the table
below refers to actual compensation granted or paid to the director or officer during the year 2024.
|
Name and Position of director or
officer |
Base
Salary
or
Other
Payment
(1) |
Value of
Social
Benefits
(2) |
Value of
Equity Based
Compensation
Granted
(3) |
All Other
Compensation
(4) |
Total |
|||||||||||||||
|
(Amounts in U.S. dollars are based on 2024 monthly average representative
U.S. dollar – NIS rate of exchange) |
||||||||||||||||||||
|
Alon Seri-Levy / Former Chief Executive Officer |
324 |
64 |
392 |
321 |
1,101 |
|||||||||||||||
|
Gilad Mamlok / Former Chief Financial Officer |
263 |
52 |
- |
206 |
521 |
|||||||||||||||
|
Ofer Toledano / VP R&D |
204 |
58 |
107 |
89 |
458 |
|||||||||||||||
|
Ofra Levy-Hacham / VP Clinical, RA & QAA |
172 |
50 |
86 |
67 |
375 |
|||||||||||||||
|
Tamar Fishman Jutkowitz / VP & General Counsel |
162 |
48 |
35 |
61 |
306 |
|||||||||||||||
|
(1) |
“Base Salary or Other Payment” means the aggregate yearly gross monthly
salaries or other payments with respect to the Company's Executive Officers and members of the board of directors for the year 2024.
|
|
(2) |
“Social Benefits” include payments to the National Insurance Institute,
advanced education funds, managers’ insurance and pension funds; vacation pay; and recuperation pay as mandated by Israeli law.
|
|
(3) |
Consists of the fair value of the equity-based compensation granted during 2024 in
exchange for the directors and officers services recognized as an expense in profit or loss and is carried to the accumulated deficit
under equity. The total amount recognized as an expense over the vesting period of the options. |
|
(4) |
“All Other Compensation” includes, among other things, car-related
expenses, communication expenses, basic health insurance, holiday presents, and 2022, 2023 and 2024 special bonuses that officers received.
|
In addition, all of our directors and executive officers are
covered under our directors’ and executive officers’ liability insurance policies and were granted letters of indemnification
by us.
87
Employment Agreements
We have entered into written employment agreements with each of
our executive officers. These agreements provide for notice periods of varying duration for termination of the agreement by us or by the
relevant executive officer, during which time the executive officer will continue to receive base salary and benefits. These agreements
also contain customary provisions regarding noncompetition, confidentiality of information and assignment of inventions. However, the
enforceability of the noncompetition provisions may be limited under applicable law. See “Item 3. Key Information – D. Risk
Factors — Risks Related to Employee Matters" — Under applicable employment laws, we may not be able to enforce covenants not
to compete” for a further description of the enforceability of non-competition clauses.
On August 27, 2024, our shareholders approved a mutual termination
agreement between us and Dr. Alon Seri-Levy, in light of his significant contributions to the Company since its inception, and in
order to allow a smooth transition period from Dr. Seri-Levy to his successor, Mr. Arkin. The agreement contained the following
terms, among others:
| - |
Dr. Seri-Levy stepped down from his positions as CEO and director of the Company, effective as of December 31, 2024; |
| - |
Dr. Seri-Levy was paid a severance amount equal to approximately $126,856 (based on the exchange rate of $1.00 U.S. = NIS 3.61;
and |
| - |
We and Dr. Seri-Levy entered into a consulting agreement, pursuant to which Dr. Seri-Levy is to provide ongoing consultation to his
successor as CEO and management relating to the Company’s clinical development program and ongoing operations. Dr. Seri-Levy is
to perform the services on an “as needed” basis and up to ten (10) hours per month for a payment of NIS 7,500 per month plus
VAT and reimbursement out-of-pocket expenses pre-approved in writing. In the event that additional hours of services are needed the parties
will discuss in good faith an hourly fee. The consulting agreement will be for a term of twelve months, following which each party
may terminate the agreement by providing a thirty (30) days prior written notice. |
For information on exemption and indemnification letters
granted to our directors and officers, please see “Item 6. Directors, Senior Management and Employees - C. Board Practices –
Exculpation, Insurance and Indemnification of Directors and Officers”.
Director Compensation
We currently pay our external directors and our other independent
directors is as follows: (i) $40,000 annually in cash; (ii) $5,000 annually in cash for service on each of the Audit Committee and/or
Compensation Committee (as the case may be) and (iii) $10,000 annually in cash for service as chairman of the Audit Committee and/or Compensation
Committee (as the case may be), which includes amounts payable under clause (ii) (all cash amounts to be paid quarterly).
In addition, in 2018 and 2019 each of our external
directors and our other independent directors received an aggregate of 11,500 Restricted Share Units ("RSUs") for the first three years
of their service as a director, with a three-year vesting and in accordance with the Company's 2014 Share Incentive Plan, in 2021 each
of our external directors and our other independent directors received 45,000 options ("Options"), at an exercise price of $10.02 with
a three-year vesting and in accordance with the Company's 2014 Share Incentive Plan. On February 28, 2024, our shareholders approved
the grant of options to purchase 75,000 ordinary shares of the Company at an exercise price equal to $1.20 per ordinary share to each
of our external and independent directors (other than Mr. Jerrold S. Gattegno, whose term of office ended on March 22, 2024) with a three-year
vesting and in accordance with the Company's 2014 Share Incentive Plan.
There is no limit regarding the number and/or hours of meetings,
and the director compensation includes all meetings of the Board and any Board’s committees. We do not pay compensation to the other
directors of the Company in their capacity as directors.
Compensation Policy
Our compensation policy, most recently adopted at the extraordinary general meeting
of shareholders held on April 1, 2024, which is designed to promote retention and motivation of directors and executive officers, incentivize
superior individual excellence, align the interests of our directors and executive officers with our long-term performance and provide
a risk management tool. To that end, a portion of an executive officer compensation package is targeted to reflect our short and long-term
goals, as well as the executive officer’s individual performance. On the other hand, our compensation policy includes measures designed
to reduce the executive officer’s incentives to take excessive risks that may harm us in the long-term, such as limits on the value
of cash bonuses and equity-based compensation, limitations on the ratio between the variable and the total compensation of an executive
officer and minimum vesting periods for equity-based compensation.
Our compensation policy also addresses our executive officer’s individual characteristics
(such as his or her respective position, education, scope of responsibilities and contribution to the attainment of our goals) as the
basis for compensation variation among our executive officers and considers the internal ratios between compensation of our executive
officers and directors and other employees. Pursuant to our compensation policy, the compensation that may be granted to an executive
officer may include: base salary, annual bonuses and other cash bonuses (such as a signing bonus and special bonuses with respect to any
special achievements, such as outstanding personal achievement, outstanding personal effort or outstanding company performance), equity-based
compensation, benefits and retirement and termination of service arrangements. All cash bonuses are limited to a maximum amount linked
to the executive officer’s base salary. Our compensation policy provides that we will seek to establish a base salary that is competitive
with base salaries paid to Executive Officers in a peer group of other companies operating in our industry that are similar
in their characteristics to those of our company, as much as possible, while considering, among other factors, such companies’
size and characteristics, which all shall be reviewed and approved by the Compensation Committee and Board. In addition our compensation
policy states that the total fixed and variable compensation (including equity based compensation) payable to the Company CEO shall not
exceed NIS 5 million per year, subject to increases in the consumer price index in the relevant jurisdiction in which the executive resides.
For purposes of calculating the maximum fixed and variable compensation each year, the value of any equity award will be allocated equally
over the number of years during which such equity award vests. In addition, the total variable compensation components (cash bonuses and
equity-based compensation) may not exceed 85% of each executive officer’s total compensation package with respect to any given calendar
year.
88
An annual cash bonus may be awarded to executive officers upon
the attainment of pre-set periodic objectives and individual targets. The annual cash bonus that may be granted to our executive officers
other than our chief executive officer will be based on performance objectives and a discretionary evaluation of the executive officer’s
overall performance by our chief executive officer and subject to minimum thresholds. The annual cash bonus that may be granted to executive
officers other than our chief executive officer may be based entirely on a discretionary evaluation. Furthermore, our chief executive
officer will be entitled to recommend performance objectives, and such performance objectives will be approved by our compensation committee
(and, if required by law, by our board of directors).
The performance measurable objectives of our chief executive officer
will be determined annually by our compensation committee and board of directors, will include the weight to be assigned to each achievement
in the overall evaluation. A less significant portion of the chief executive officer’s annual cash bonus may be based on a discretionary
evaluation of the chief executive officer’s overall performance by the compensation committee and the board of directors based on
quantitative and qualitative criteria.
The equity-based compensation under our compensation policy for
our executive officers (including members of our board of directors) is designed in a manner consistent with the underlying objectives
in determining the base salary and the annual cash bonus, with its main objectives being to enhance the alignment between the executive
officers’ interests with our long-term interests and those of our shareholders and to strengthen the retention and the motivation
of executive officers in the long term. Our compensation policy provides for executive officer compensation in the form of share options
or other equity-based awards, such as restricted shares and restricted share units, in accordance with our share incentive plan then in
place. All equity-based incentives granted to executive officers shall be subject to vesting periods in order to promote long-term retention
of the awarded executive officers. The equity-based compensation shall be granted from time to time and be individually determined and
awarded according to the performance, educational background, prior business experience, qualifications, role and the personal responsibilities
of the executive officer.
In addition, our compensation policy contains compensation recovery
provisions which allows us under certain conditions to recover bonuses paid in excess, enables our chief executive officer to approve
an immaterial change in the terms of employment of an executive officer (provided that the changes of the terms of employment are in accordance
our compensation policy) and allows us to exculpate, indemnify and insure our executive officers and directors subject to certain limitations
set forth thereto.
Our compensation policy provides for the following maximum compensation
of our external directors and our other independent directors: (i) $67,275 annually in cash; (ii) $7,475 annually in cash for service
on each of the Audit Committee and/or Compensation Committee (as the case may be), (iii) $37,375 annually in cash for service as chairman
of the Board, (iv) $14,950 annually in cash for service as chairman of the Audit Committee and/or Compensation Committee (as the case
may be), which includes amounts payable under clause (ii), and (v) $14,950 annually in cash for service as a lead independent director
(all cash amounts to be paid quarterly). Equity based-compensation granted to the Company’s directors shall not exceed 55% of the
total compensation paid to the Company’s directors. Our compensation policy also provides for compensation to the members
of our board of directors either (i) in accordance with the amounts provided in the Companies Regulations (Rules Regarding the Compensation
and Expenses of an External Director) of 2000, as amended by the Companies Regulations (Relief for Public Companies Traded in Stock Exchange
Outside of Israel) of 2000, as such regulations may be amended from time to time, or (ii) in accordance with the amounts determined in
our compensation policy.
Policy for Recovery of Erroneously Awarded Compensation
In accordance with the Nasdaq listing rules, our Company
has adopted a Policy for Recovery of Erroneously Awarded Compensation, or a Clawback Policy, which became effective as of October 2, 2023.
C.
Board Practices
Appointment of Directors and Terms of Officers
Our board of directors currently consists of nine directors, including
three external directors, and appointment fulfills the requirements of the Companies Law for the company to have two external directors
(see “Item 6. Directors, Senior Management and Employees - C. Board Practices – External Directors”). These three directors,
as well as two additional directors, qualify as independent directors under the corporate governance standards of the Nasdaq corporate
governance rules and the independence requirements of Rule 10A-3 of the Exchange Act.
Under our amended and restated articles of association, the number
of directors on our board of directors will be no less than five (5) and no more than ten (10), including any external directors required
to be appointed under the Companies Law. The minimum and maximum number of directors may be changed, at any time and from time to time,
by a special 66 2∕3% majority shareholder vote by those shareholders voting in person or by proxy (including by voting deed),
not taking into consideration abstaining votes.
Other than external directors, for whom special election requirements
apply under the Companies Law, as detailed below, the Israeli Companies Law and our articles of association provide that directors are
elected annually at the general meeting of our shareholders by a vote of the holders of a majority of the voting power represented present
and voting, in person or by proxy, at that meeting. We have only one class of directors. Mr. Ran Gottfried and Mr. Yuval Yanai currently
serve as our external directors. On February 28, 2024, Mr. Ran Gottfried was re-elected, and Mr. Yuval Yanai was elected, as external
directors for a term of three years.
89
Under our amended and restated articles of association, our board
of directors may elect new directors if the number of directors is below the maximum provided therein. External directors are elected
for an initial term of three years and may be elected for up to two additional three-year terms (or more) under the circumstances described
below. External directors may be removed from office only under the limited circumstances set forth in the Companies Law. See “Item
6. Directors, Senior Management and Employees - C. Board Practices – External Directors— Election and Dismissal of External
Directors” for a description of the procedure for the election of external directors.
Under Israeli law, the chief executive officer of a public company
may not serve as the chairman of the board of directors of the company unless approved by a special majority of our shareholders as required
under the Companies Law. On November 4, 2024, our shareholders approved the appointment of Mr. Moshe Arkin, the current Executive
Chairman of the Board of Directors, as the Company’s interim chief executive, in addition to his role as Executive Chairman, for
a term not to exceed twelve months.
In addition, under the Companies Law, our board of directors must
determine the minimum number of directors who are required to have financial and accounting expertise. Under applicable regulations, a
director with financial and accounting expertise is a director who, by reason of his or her education, professional experience and skill,
has a high level of proficiency in and understanding of business accounting matters and financial statements. See “Item 6. Item
6. Directors, Senior Management and Employees - C. Board Practices – External Directors — Qualifications of External
Directors.” He or she must be able to thoroughly comprehend the financial statements of the company and initiate debate regarding
the manner in which financial information is presented. In determining the number of directors required to have such expertise, the board
of directors must consider, among other things, the type and size of the company and the scope and complexity of its operations. Our board
of directors has determined that we require at least one director with the requisite financial and accounting expertise and that has such
expertise.
There are no family relationships among any of our office holders
(including directors), other than Mr. Itai Arkin who is the son of Mr. Moshe Arkin.
Alternate Directors
Our amended and restated articles of association provide, as allowed
by the Companies Law, that any director may, by written notice to us, appoint another person who is qualified to serve as a director to
serve as an alternate director. The alternate director will be regarded as a director. Under the Companies Law, a person who is not qualified
to be appointed as a director, a person who is already serving as a director or a person who is already serving as an alternate director
for another director, may not be appointed as an alternate director. Nevertheless, a director who is already serving as a director may
be appointed as an alternate director for a member of a committee of the board of directors as long as he or she is not already serving
as a member of such committee, and if the alternate director is to replace an external director, he or she is required to be an external
director and to have either “financial and accounting expertise” or “professional expertise,” depending on the
qualifications of the external director he or she is replacing. The term of appointment of an alternate director may be for one meeting
of the board of directors or until notice is given of the cancellation of the appointment. A person who does not have the requisite “financial
and accounting experience” or the “professional expertise,” depending on the qualifications of the external director
he or she is replacing, may not be appointed as an alternate director for an external director.
External Directors
Qualifications of External Directors
Under the Companies Law, companies incorporated under the laws
of the State of Israel that are “public companies,” including companies with shares listed on The Nasdaq Capital Market, are
generally required to appoint at least two external directors who meet the qualification requirements set forth in the Companies Law.
A person may not be appointed as an external director if
the person is a relative of a controlling shareholder or if on the date of the person’s appointment or within the preceding two
years the person or his or her relatives, partners, employers or anyone to whom that person is subordinate, whether directly or indirectly,
or entities under the person’s control have or had any affiliation with any of (each an “Affiliated Party”):
(1) us; (2) any person or entity controlling us on the date of such appointment; (3) any relative of a controlling shareholder; or (4)
any entity controlled, on the date of such appointment or within the preceding two years, by us or by a controlling shareholder. If there
is no controlling shareholder or any shareholder holding 25% or more of voting rights in the company, a person may not be appointed as
an external director if the person has any affiliation to the chairman of the board of directors, the general manager (chief executive
officer), any shareholder holding 5% or more of the company’s shares or voting rights or the senior financial officer as of the
date of the person’s appointment.
90
The term “controlling shareholder” means a shareholder
with the ability to direct the activities of the company, other than by virtue of being an office holder. A shareholder is presumed to
have “control” of the company and thus to be a controlling shareholder of the company if the shareholder holds 50% or more
of the “means of control” of the company. “Means of control” is defined as (1) the right to vote at a general
meeting of a company or a corresponding body of another corporation; or (2) the right to appoint directors of the corporation or its general
manager. For the purpose of approving related-party transactions, the term also includes any shareholder that holds 25% or more of the
voting rights of the company if the company has no shareholder that owns more than 50% of its voting rights. For the purpose of determining
the holding percentage stated above, two or more shareholders who have a personal interest in a transaction that is brought for the company’s
approval are deemed as joint holders.
| • |
The term affiliation includes: |
| • |
an employment relationship; |
| • |
a business or professional relationship maintained on a regular basis; |
| • |
control; and |
| • |
service as an office holder, excluding service as a director in a private company prior to the first offering of its shares to the
public if such director was appointed as a director of the private company in order to serve as an external director following the initial
public offering. |
The term “relative” is defined as a spouse, sibling,
parent, grandparent, descendant, spouse’s descendant, sibling and parent and the spouse of each of the foregoing.
The term “office holder” is defined as a general manager,
chief business manager, deputy general manager, vice general manager, director or manager directly subordinate to the general manager
or any other person assuming the responsibilities of any of the foregoing positions, without regard to such person’s title.
A person may not serve as an external director if that person or
that person’s relative, partner, employer, a person to whom such person is subordinate (directly or indirectly) or any entity under
the person’s control has a business or professional relationship with any entity that has an affiliation with any Affiliated Party,
even if such relationship is intermittent (excluding insignificant relationships). Additionally, any person who has received compensation
intermittently (excluding insignificant relationships) other than compensation permitted under the Companies Law may not continue to serve
as an external director.
No person can serve as an external director if the person’s
position or other affairs create, or may create, a conflict of interest with the person’s responsibilities as a director or may
otherwise interfere with the person’s ability to serve as a director or if such a person is an employee of the Israeli Securities
Authority or of an Israeli stock exchange. If at the time an external director is appointed all current members of the board of directors,
who are not controlling shareholders or relatives of controlling shareholders, are of the same gender, then the external director to be
appointed must be of the other gender. In addition, a person who is a director of a company may not be elected as an external director
of another company if, at that time, a director of the other company is acting as an external director of the first company.
The Companies Law provides that an external director must meet
certain professional qualifications or have financial and accounting expertise and that at least one external director must have financial
and accounting expertise. However, if at least one of our other directors (1) meets the independence requirements of the Exchange
Act, (2) meets the standards of the Nasdaq corporate governance rules for membership on the audit committee and (3) has financial and
accounting expertise as defined in the Companies Law and applicable regulations, then neither of our external directors is required to
possess financial and accounting expertise as long as both possess other requisite professional qualifications. The determination of whether
a director possesses financial and accounting expertise is made by the board of directors. A director with financial and accounting expertise
is a director who by virtue of his or her education, professional experience and skill, has a high level of proficiency in and understanding
of business accounting matters and financial statements so that he or she is able to fully understand our financial statements and initiate
debate regarding the manner in which the financial information is presented.
The regulations promulgated under the Companies Law define an external
director with requisite professional qualifications as a director who satisfies one of the following requirements: (1) the director holds
an academic degree in either economics, business administration, accounting, law or public administration, (2) the director either holds
an academic degree in any other field or has completed another form of higher education in the company’s primary field of business
or in an area which is relevant to his or her office as an external director in the company, or (3) the director has at least five years
of experience serving in any one of the following, or at least five years of cumulative experience serving in two or more of the following
capacities: (a) a senior business management position in a company with a substantial scope of business, (b) a senior position in the
company’s primary field of business or (c) a senior position in public administration.
Until the lapse of a two-year period from the date that an
external director of a company ceases to act in such capacity, the company in which such external director served, and its controlling
shareholder or any entity under control of such controlling shareholder may not, directly or indirectly, grant such former external director,
or his or her spouse or child, any benefit, including via (i) the appointment of such former director or his or her spouse or his child
as an officer in the company or in an entity controlled by the company’s controlling shareholder, (ii) the employment of such former
director, and (iii) the engagement, directly or indirectly, of such former director as a provider of professional services for compensation,
directly or indirectly, including via an entity under his or her control. With respect to a relative who is not a spouse or a child, such
limitations shall only apply for one year from the date such external director ceased to be engaged in such capacity.
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Election and Dismissal of External
Directors
Under Israeli law, external directors are elected by a majority
vote at a shareholders’ meeting, provided that either:
| • |
the majority of the shares that are voted at the meeting in favor of the election of the external director, excluding abstentions,
include at least a majority of the votes of shareholders who are not controlling shareholders and do not have a personal interest in the
appointment (excluding a personal interest that did not result from the shareholder’s relationship with the controlling shareholder);
or |
| • |
the total number of shares held by non-controlling shareholders or any one on their behalf that are voted against the election of
the external director does not exceed two percent of the aggregate voting rights in the company. |
Under Israeli law, the initial term of an external director of an Israeli public company
is three years. The external director may be re-elected, subject to certain circumstances and conditions, for up to two additional terms
of three years each, and thereafter, subject to conditions set out in the regulations promulgated under the Companies Law, to further
three year terms, each re-election subject to one of the following:
| • |
his or her service for each such additional term is recommended by one or more shareholders holding at least 1% of the company’s
voting rights and is approved at a shareholders meeting by a disinterested majority, where the total number of shares held by non-controlling,
disinterested shareholders voting for such reelection exceeds 2% of the aggregate voting rights in the company and subject to additional
restrictions set forth in the Companies Law with respect to the affiliation of the external director nominee; |
| • |
the external director proposed his or her own nomination, and such nomination was approved in accordance with the requirements described
in the paragraph above; or |
| • |
his or her service for each such additional term is recommended by the board of directors and is approved at a meeting of shareholders
by the same majority required for the initial election of an external director (as described above). |
An external director may be removed by the same special majority
of the shareholders required for his or her election, if he or she ceases to meet the statutory qualifications for appointment or if he
or she violates his or her fiduciary duty to the company. An external director may also be removed by order of an Israeli court if the
court finds that the external director is permanently unable to exercise his or her office, has ceased to meet the statutory qualifications
for his or her appointment, has violated his or her fiduciary duty to the company, or has been convicted by a court outside Israel of
certain offenses detailed in the Companies Law.
If the vacancy of an external directorship causes a company to
have fewer than two external directors, the company’s board of directors is required under the Companies Law to call a special general
meeting of the company’s shareholders as soon as possible to appoint such number of new external directors so that the company thereafter
has two external directors.
Additional Provisions
Under the Companies Law, each committee authorized to exercise
any of the powers of the board of directors is required to include at least one external director and its audit and compensation committees
are required to include all of the external directors.
An external director is entitled to compensation and reimbursement
of expenses in accordance with regulations promulgated under the Companies Law and is prohibited from receiving any other compensation,
directly or indirectly, in connection with serving as a director except for certain exculpation, indemnification and insurance provided
by the company, as specifically allowed by the Companies Law.
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Audit Committee
Companies Law Requirements
Under the Companies Law, the board of directors of any public company
must also appoint an audit committee comprised of at least three directors, including all of the external directors. The audit committee
may not include:
| • |
the chairman of the board of directors; |
| • |
a controlling shareholder or a relative of a controlling shareholder; |
| • |
any director employed by us or by one of our controlling shareholders or by an entity controlled by our controlling shareholders
(other than as a member of the board of directors); or |
| • |
any director who regularly provides services to us, to one of our controlling shareholders or to an entity controlled by our controlling
shareholders. |
According to the Companies Law, the majority of the members of
the audit committee, as well as the majority of members present at audit committee meetings, will be required to be “independent”
(as defined below) and the chairman of the audit committee will be required to be an external director. Any persons disqualified from
serving as a member of the audit committee may not be present at the audit committee meetings, unless the chairman of the audit committee
has determined that such person is required to be present at the meeting or if such person qualifies under one of the exemptions of the
Companies Law.
The term “independent director” is defined under the
Companies Law as an external director or a director who meets the following conditions and who is appointed or classified as such according
to the Companies Law: (1) the conditions for his or her appointment as an external director (as described above) are satisfied and the
audit committee approves the director having met such conditions and (2) he or she has not served as a director of the company for over
nine consecutive years with any interruption of up to two years of his or her service not being deemed a disruption to the continuity
of his or her service.
Nasdaq Listing Requirements
Under the Nasdaq corporate governance rules, we are required to
maintain an audit committee consisting of at least three independent directors, all of whom are financially literate and one of whom has
accounting or related financial management expertise.
Our audit committee consists of Ran Gottfried, Sharon Kochan,
and Yuval Yanai, Yuval Yanai serves as Chairman of the committee. All members of our audit committee meet the requirements for financial
literacy under the applicable rules and regulations of the SEC and the Nasdaq corporate governance rules. Our board of directors has determined
that each of Mr. Ran Gottfried and Mr. Yuval Yanai is an audit committee financial expert as defined by SEC rules and has the requisite
financial experience as defined by the Nasdaq corporate governance rules.
Each of the members of the audit committee is “independent”
as such term is defined in Rule 10A-3(b)(1) under the Exchange Act.
Approval of Transactions with
Related Parties
The approval of the audit committee is required to effect specified
actions and transactions with office holders and controlling shareholders and their relatives, or in which they have a personal interest.
See “Item 6. Directors, Senior Management and Employees - C. Board Practices – Duties of Directors and Officers and Approval
of Specified Related Party Transactions under the Israeli Companies Law – Fiduciary Duties of Office Holders.” The audit committee
may not approve an action or a transaction with a controlling shareholder or with an office holder unless at the time of approval the
audit committee meets the composition requirements under the Companies Law.
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Audit Committee Role
Our board of directors has adopted an audit committee charter
effective immediately after the pricing of our initial public offering setting forth the responsibilities of the audit committee consistent
with the rules of the SEC and the Nasdaq corporate governance rules, which include:
| • |
retaining and terminating our independent auditors, subject to board of directors and shareholder ratification; |
| • |
overseeing the independence, compensation and performance of the Company’s independent auditors; |
| • |
the appointment, compensation, retention and oversight of any accounting firm engaged for the purpose of preparing or issuing an
audit report or performing other audit services; |
| • |
pre-approval of audit and non-audit services to be provided by the independent auditors; |
| • |
reviewing with management and our independent directors our financial statements prior to their submission to the SEC; and
|
| • |
approval of certain transactions with office holders and controlling shareholders, as described below, and other related party transactions.
|
Additionally, under the Companies Law, the role of the audit committee
includes the identification of irregularities in our business management, among other things, by consulting with the internal auditor
or our independent auditors and suggesting an appropriate course of action to the board of directors. In addition, the audit committee
or the board of directors, as set forth in the articles of association of the company, is required to approve the yearly or periodic work
plan proposed by the internal auditor. The audit committee is required to assess the company’s internal audit system and the performance
of its internal auditor. The Companies Law also requires that the audit committee assess the scope of the work and compensation of the
company’s external auditor. In addition, the audit committee is required to determine whether certain related party actions and
transactions are “material” or “extraordinary” for the purpose of the requisite approval procedures under the
Companies Law and whether certain transactions with a controlling shareholder will be subject to a competitive procedure. The audit committee
charter states that in fulfilling its role the committee is empowered to conduct or authorize investigations into any matters within its
scope of responsibilities. A company whose audit committee’s composition also meets the requirements set for the composition of
a compensation committee (as further detailed below) may have one committee acting as both audit and compensation committees.
Compensation Committee
Under the Companies Law, public companies are required to appoint
a compensation committee in accordance with the guidelines set forth thereunder.
The compensation committee must consist of at least three members.
All of the external directors must serve on the committee and constitute a majority of its members. The chairman of the compensation committee
must be an external director. The remaining members are not required to be external directors, but must be directors who qualify to serve
as members of the audit committee (as described above).
The compensation committee, which consists of Ran Gottfried, Mr.
Yuval Yanai and Sharon Kochan, assists the board of directors in determining compensation for our directors and officers. Ran Gottfried
serves as Chairman of the committee. Under SEC and Nasdaq rules, there are heightened independence standards for members of the compensation
committee, including a prohibition against the receipt of any compensation from us other than standard supervisory board member fees.
Although foreign private issuers are not required to meet this heightened standard, our board of directors has determined that all of
our expected compensation committee members meet this heightened standard.
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In accordance with the Companies Law, the roles of the compensation
committee are, among others, as follows:
| (1) |
to recommend to the board of directors the compensation policy for directors and officers, and to recommend to the board of directors
once every three years whether the compensation policy that had been approved should be extended for a period of more than three years;
|
| (2) |
to recommend to the board of directors updates to the compensation policy, from time to time, and examine its implementation;
|
| (3) |
to decide whether to approve the terms of office and employment of directors and officers that require approval of the compensation
committee; and |
| (4) |
to decide whether the compensation terms of the chief executive officer, which were determined pursuant to the compensation policy,
will be exempted from approval by the shareholders because such approval would harm the ability to engage the chief executive officer.
|
In addition to the roles mentioned above our compensation committee
also makes recommendations to our board of directors regarding the awarding of employee equity grants.
In general, under the Companies Law, a public company must have
a compensation policy approved by the board of directors after receiving and considering the recommendations of the compensation committee.
In addition, the compensation policy requires the approval of the general meeting of the shareholders. In public companies such as our
company, shareholder approval requires one of the following: (i) the majority of shareholder votes counted at a general meeting including
the majority of all of the votes of those shareholders who are non-controlling shareholders and do not have a personal interest in the
approval of the compensation policy, who vote at the meeting (excluding abstentions) or (ii) the total number of votes against the proposal
among the shareholders mentioned in paragraph (i) does exceed two percent (2%) of the voting rights in the company. Under special circumstances,
the board of directors may approve the compensation policy despite the objection of the shareholders on the condition that the compensation
committee and then the board of directors decide, on the basis of detailed arguments and after discussing again the compensation policy,
that approval of the compensation policy, despite the objection of the meeting of shareholders, is for the benefit of the company.
If a company initially offer its securities to the public, like
we recently did, adopts a compensation policy in advance of its initial public offering, and describes it in its prospectus, then such
compensation policy shall be deemed a validly adopted policy in accordance with the Companies Law requirements described above. Furthermore,
if the compensation policy is set in accordance with the aforementioned relief, then it will remain in effect for a term of five years
from the date such company has become a public company.
The compensation policy must be based on certain considerations,
include certain provisions and needs to reference certain matters as set forth in the Companies Law.
The compensation policy must serve as the basis for decisions concerning
the financial terms of employment or engagement of office holders, including exculpation, insurance, indemnification or any monetary payment
or obligation of payment in respect of employment or engagement. The compensation policy must relate to certain factors, including advancement
of the company’s objectives, business plan and long-term strategy, and creation of appropriate incentives for office holders. It
must also consider, among other things, the company’s risk management, size and the nature of its operations. The compensation policy
must furthermore consider the following additional factors:
| • |
the education, skills, experience, expertise and accomplishments of the relevant office holder; |
| • |
the office holder’s position, responsibilities and prior compensation agreements with him or her; |
| • |
the ratio between the cost of the terms of employment of an office holder and the cost of the employment of other employees of the
company, including employees employed through contractors who provide services to the company, in particular the ratio between such cost,
the average and median salary of the employees of the company, as well as the impact of such disparities on the work relationships in
the company; |
| • |
if the terms of employment include variable components — the possibility of reducing variable components at the discretion
of the board of directors and the possibility of setting a limit on the value of non-cash variable equity-based components; and
|
| • |
if the terms of employment include severance compensation — the term of employment or office of the office holder, the terms
of his or her compensation during such period, the company’s performance during such period, his or her individual contribution
to the achievement of the company goals and the maximization of its profits and the circumstances under which he or she is leaving the
company. |
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The compensation policy must also include, among others:
| • |
with regards to variable components: |
| - |
with the exception of office holders who report directly to the chief executive officer, determining the variable components on long-term
performance basis and on measurable criteria; however, the company may determine that an immaterial part of the variable components of
the compensation package of an office holder’s shall be awarded based on non-measurable criteria, if such amount is not higher than
three monthly salaries per annum, while taking into account such office holder contribution to the company; |
| - |
the ratio between variable and fixed components, as well as the limit of the values of variable components at the time of their grant.
|
| • |
a condition under which the office holder will return to the company, according to conditions to be set forth in the compensation
policy, any amounts paid as part of his or her terms of employment, if such amounts were paid based on information later to be discovered
to be wrong, and such information was restated in the company’s financial statements; |
| • |
the minimum holding or vesting period of variable equity-based components to be set in the terms of office or employment, as applicable,
while taking into consideration long-term incentives; and |
| • |
a limit to retirement grants. |
Corporate Governance Practices
Internal Auditor
Under the Companies Law, the board of directors of a public company
must appoint an internal auditor based on the recommendation of the audit committee. The role of the internal auditor is, among other
things, to examine whether a company’s actions comply with applicable law and orderly business procedure. Under the Companies Law,
the internal auditor may not be an interested party or an office holder or a relative of an interested party or of an office holder, nor
may the internal auditor be the company’s independent auditor or the representative of the same.
An “interested party” is defined in the Companies Law
as (i) a holder of 5% or more of the issued share capital or voting power in a company, (ii) any person or entity who has the right to
designate one or more directors or to designate the chief executive officer of the company, or (iii) any person who serves as a director
or as a chief executive officer of the company. As of the date of this annual report, we appointed Mr. Oren Grupi, CPA, who serves as
partner at KPMG Somekh Chaikin, as our internal auditor.
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Duties of Directors and Officers and Approval of Specified
Related Party Transactions under the Israeli Companies Law
Fiduciary Duties of Office Holders
The Companies Law imposes a duty of care and a fiduciary duty on
all office holders of a company. The duty of care of an office holder is based on the duty of care set forth in connection with the tort
of negligence under the Israeli Torts Ordinance (New Version) 5728-1968. This duty of care requires an office holder to act with the degree
of proficiency with which a reasonable office holder in the same position would have acted under the same circumstances. The duty of care
includes, among other things, a duty to use reasonable means, in light of the circumstances, to obtain:
| • |
information on the business advisability of a given action brought for his or her approval or performed by virtue of his or
her position; and |
| • |
all other important information pertaining to such action. |
| • |
The fiduciary duty incumbent on an office holder requires him or her to act in good faith and for the benefit of the company, and
includes, among other things, the duty to: |
| • |
refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her
other duties or personal affairs; |
| • |
refrain from any activity that is competitive with the business of the company; |
| • |
refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself
or others; and |
| • |
disclose to the company any information or documents relating to the company’s affairs which the office holder received as
a result of his or her position as an office holder. |
We may approve an act specified above which would otherwise constitute
a breach of the office holder’s fiduciary duty, provided that the office holder acted in good faith, the act or its approval does
not harm the company, and the office holder discloses his or her personal interest a sufficient time before the approval of such act.
Any such approval is subject to the terms of the Companies Law, setting forth, among other things, the appropriate bodies of the company
entitled to provide such approval, and the methods of obtaining such approval.
Disclosure of Personal Interests
of an Office Holder and Approval of Transactions
The Companies Law requires that an office holder promptly disclose
to the company any personal interest that he or she may have and all related material information or documents relating to any existing
or proposed transaction by the company. An interested office holder’s disclosure must be made promptly and in any event no later
than the first meeting of the board of directors at which the transaction is considered. An office holder is not obliged to disclose such
information if the personal interest of the office holder derives solely from the personal interest of his or her relative in a transaction
that is not considered an extraordinary transaction.
Under the Companies Law, once an office holder has complied with
the above disclosure requirement, a company may approve a transaction between the company and the office holder or a third party in which
the office holder has a personal interest. However, a company may not approve a transaction or action that is not to the company’s
benefit.
97
Under the Companies Law, unless the articles of association of
a company provide otherwise, a transaction with an office holder or with a third party in which the office holder has a personal interest,
which is not an extraordinary transaction, requires approval by the board of directors. Our amended and restated articles of association
provide that such a transaction, which is not an extraordinary transaction, shall be approved by the board of directors or a committee
of the board of directors or any other body or person (which has no personal interest in the transaction) authorized by the board of directors.
If the transaction considered is an extraordinary transaction with an office holder or third party in which the office holder has a personal
interest, then audit committee approval is required prior to approval by the board of directors. For the approval of compensation arrangements
with directors and executive officers, see “Item 6. Directors, Senior Management and Employees - C. Board Practices – Duties
of Directors and Officers and Approval of Specified Related Party Transactions under the Israeli Companies Law – Fiduciary
Duties of Office Holders.”
Any persons who have a personal interest in the approval of a transaction
that is brought before a meeting of the board of directors or the audit committee may not be present at the meeting or vote on the matter.
However, if the chairman of the board of directors or the chairman of the audit committee has determined that the presence of an office
holder with a personal interest is required, such office holder may be present at the meeting for the purpose of presenting the matter.
Notwithstanding the foregoing, a director who has a personal interest may be present at the meeting and vote on the matter if a majority
of the directors or members of the audit committee have a personal interest in the approval of such transaction. If a majority of the
directors at a board of directors meeting have a personal interest in the transaction, such transaction also requires approval of the
shareholders of the company.
A “personal interest” is defined under the Companies
Law as the personal interest of a person in an action or in a transaction of the company, including the personal interest of such person’s
relative or the interest of any other corporate body in which the person and/or such person’s relative is a director or general
manager, a 5% shareholder or holds 5% or more of the voting rights, or has the right to appoint at least one director or the general manager,
but excluding a personal interest stemming solely from the fact of holding shares in the company. A personal interest also includes (1)
a personal interest of a person who votes according to a proxy of another person, including in the event that the other person has no
personal interest, and (2) a personal interest of a person who gave a proxy to another person to vote on his or her behalf regardless
of whether or not the discretion of how to vote lies with the person voting.
An “extraordinary transaction” is defined under the
Companies Law as any of the following:
| • |
a transaction other than in the ordinary course of business; |
| • |
a transaction that is not on market terms; or |
| • |
a transaction that may have a material impact on the company’s profitability, assets or liabilities. |
Disclosure of Personal Interests
of a Controlling Shareholder and Approval of Transactions
The Companies Law also requires that a controlling shareholder
promptly disclose to the company any personal interest that he or she may have and all related material information or documents relating
to any existing or proposed transaction by the company. A controlling shareholder’s disclosure must be made promptly and, in any
event, no later than the first meeting of the board of directors at which the transaction is considered. Extraordinary transactions with
a controlling shareholder or in which a controlling shareholder has a personal interest, including a private placement in which a controlling
shareholder has a personal interest, and the terms of engagement of the company, directly or indirectly, with a controlling shareholder
or a controlling shareholder’s relative (including through a corporation controlled by a controlling shareholder), regarding the
company’s receipt of services from the controlling shareholder, and if such controlling shareholder is also an office holder or
employee of the company, regarding his or her terms of employment, require the approval of each of (i) the audit committee or the
compensation committee with respect to the terms of the engagement of the company, (ii) the board of directors and (iii) the shareholders,
in that order. In addition, the shareholder approval must fulfill one of the following requirements:
| • |
majority of the shares held by shareholders who have no personal interest in the transaction and are voting at the meeting must be
voted in favor of approving the transaction, excluding abstentions; or |
| • |
the shares voted by shareholders who have no personal interest in the transaction who vote against the transaction represent no more
than two percent (2%) of the voting rights in the company. |
98
In addition, an extraordinary transaction with a controlling shareholder
or in which a controlling shareholder has a personal interest, and an engagement of the company, directly or indirectly, with a controlling
shareholder or a controlling shareholder’s relative (including through a corporation controlled by a controlling shareholder), regarding
the company’s receipt of services from the controlling shareholder, and if such controlling shareholder is also an office holder
or employee of the company, regarding his or her terms of employment, in each case with a term of more than three years requires the abovementioned
approval every three years, however, transactions not involving the receipt of services or compensation can be approved for a longer term,
provided that the audit committee determines that such longer term is reasonable under the circumstances. In addition, transactions with
a controlling shareholder or a controlling shareholder’s relative who serves as an officer in a company, directly or indirectly
(including through a corporation under his control), involving the receipt of services by a company or their compensation can have a term
of five years from the company's initial public offering under certain circumstances.
The Companies Law requires that every shareholder that participates,
in person, by proxy or by voting instrument, in a vote regarding a transaction with a controlling shareholder, must indicate in advance
or in the ballot whether or not that shareholder has a personal interest in the vote in question. Failure to so indicate will result in
the invalidation of that shareholder’s vote.
Disclosure of Compensation of
Executive Officers
For so long as we qualify as a foreign private issuer, we are not
required to comply with the proxy rules applicable to U.S. domestic companies, including the requirement to disclose the compensation
of our chief executive officer and certain other most highly compensated executive officers on an individual, rather than an aggregate,
basis. Nevertheless, regulations promulgated under the Companies Law will require us, after we became a public company, to disclose the
annual compensation of our five most highly compensated office holders on an individual basis, rather than on an aggregate basis. This
disclosure will not be as extensive as that required of a U.S. domestic issuer.
Compensation of Directors and
Executive Officers
Directors. Under the
Companies Law, the compensation of our directors requires the approval of our compensation committee, the subsequent approval of the board
of directors and, unless exempted under regulations promulgated under the Companies Law, the approval of the shareholders at a general
meeting. If the compensation of our directors is inconsistent with our stated compensation policy, then, those provisions that must be
included in the compensation policy according to the Companies Law must have been considered by the compensation committee and board of
directors, and shareholder approval will also be required, provided that:
| • |
at least a majority of the shares held by all shareholders who are not controlling shareholders and do not have a personal interest
in such matter, present and voting at such meeting, are voted in favor of the compensation package, excluding abstentions; or |
| • |
the total number of shares of non-controlling shareholders and shareholders who do not have a personal interest in such matter voting
against the compensation package does not exceed two percent (2%) of the aggregate voting rights in the company. |
Executive officers other than
the chief executive officer. The Companies Law requires the approval of the compensation of a public company’s executive
officers (other than the chief executive officer) in the following order: (i) the compensation committee, (ii) the company’s board
of directors, and (iii) if such compensation arrangement is inconsistent with the company’s stated compensation policy, the company’s
shareholders (by a special majority vote as discussed above with respect to the approval of director compensation). However, if the shareholders
of the company do not approve a compensation arrangement with an executive officer that is inconsistent with the company’s stated
compensation policy, the compensation committee and board of directors may override the shareholders’ decision if each of the compensation
committee and the board of directors provide detailed reasons for their decision.
Chief executive officer.
Under the Companies Law, the compensation of a public company’s chief executive officer is required to be approved by: (i) the company’s
compensation committee; (ii) the company’s board of directors, and (iii) the company’s shareholders (by a special majority
vote as discussed above with respect to the approval of director compensation). However, if the shareholders of the company do not approve
the compensation arrangement with the chief executive officer, the compensation committee and board of directors may override the shareholders’
decision if each of the compensation committee and the board of directors provide a detailed report for their decision. The approval of
each of the compensation committee and the board of directors should be in accordance with the company’s stated compensation policy;
however, in special circumstances, they may approve compensation terms of a chief executive officer that are inconsistent with such policy
provided that they have considered those provisions that must be included in the compensation policy according to the Companies Law and
that shareholder approval was obtained (by a special majority vote as discussed above with respect to the approval of director compensation).
In addition, the compensation committee may waive the shareholder approval requirement with regards to the approval of the engagement
terms of a candidate for the chief executive officer position, if they determine that the compensation arrangement is consistent with
the company’s stated compensation policy, and that the chief executive officer did not have a prior business relationship with the
company or a controlling shareholder of the company and that subjecting the approval of the engagement to a shareholder vote would impede
the company’s ability to employ the chief executive officer candidate.
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Duties of Shareholders
Under the Companies Law, a shareholder has a duty to refrain from
abusing its power in the company and to act in good faith and in an acceptable manner in exercising its rights and performing its obligations
to the company and other shareholders, including, among other things, when voting at meetings of shareholders on the following matters:
| • |
an amendment to the articles of association; |
| • |
an increase in the company’s authorized share capital; |
| • |
a merger; and |
| • |
the approval of related party transactions and acts of office holders that require shareholder approval. |
A shareholder also has a general duty to refrain from discriminating
against other shareholders.
The remedies generally available upon a breach of contract will
also apply to a breach of the shareholder duties mentioned above, and in the event of discrimination against other shareholders, additional
remedies may be available to the injured shareholder.
In addition, any controlling shareholder, any shareholder that
knows that its vote can determine the outcome of a shareholder vote and any shareholder that, under a company’s articles of association,
has the power to appoint or prevent the appointment of an office holder, or any other power with respect to a company, is under a duty
to act with fairness towards the company. The Companies Law does not describe the substance of this duty except to state that the remedies
generally available upon a breach of contract will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s
position in the company into account.
Approval of Private Placements
Under the Companies Law and the regulations promulgated thereunder,
a private placement of securities does not require approval at a general meeting of the shareholders of a company; provided however, that
in special circumstances, such as a private placement which is intended to obviate the need to conduct a special tender offer (see “Item
10. Additional Information— Memorandum of Association – Acquisitions under Israeli Law”) or a private placement which
qualifies as a related party transaction (see “Item 6. Directors, Senior Management and Employees - C. Board Practices – Duties
of Directors and Officers and Approval of Specified Related Party Transactions under the Israeli Companies Law – Fiduciary Duties
of Office Holders”), approval at a general meeting of the shareholders of a company is required.
Exculpation, Insurance and Indemnification of Directors and Officers
Under the Companies Law, a company may not exculpate an office
holder from liability for a breach of the fiduciary duty. An Israeli company may exculpate an office holder in advance from liability
to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care but only if a provision
authorizing such exculpation is included in its articles of association. Our amended and restated articles of association include such
a provision. The company may not exculpate in advance a director from liability arising due to the breach of his or her duty of care in
the event of a prohibited dividend or distribution to shareholders.
Under the Companies Law and the Israeli Securities Law, 5728-1968,
or the Securities Law, a company may indemnify an office holder in respect of the following liabilities, payments and expenses incurred
for acts performed by him or her as an office holder, either in advance of an event or following an event, provided its articles of association
include a provision authorizing such indemnification:
| • |
a monetary liability incurred by or imposed on the office holder in favor of another person pursuant to a court judgment, including
pursuant to a settlement confirmed as judgment or arbitrator’s decision approved by a competent court. However, if an undertaking
to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events
which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify
is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such
undertaking shall detail the abovementioned foreseen events and amount or criteria; |
100
| • |
reasonable litigation expenses, including reasonable attorneys’ fees, which were incurred by the office holder as a result
of an investigation or proceeding filed against the office holder by an authority authorized to conduct such investigation or proceeding,
provided that such investigation or proceeding was either (i) concluded without the filing of an indictment against such office holder
and without the imposition on him of any monetary obligation in lieu of a criminal proceeding; (ii) concluded without the filing of an
indictment against the office holder but with the imposition of a monetary obligation on the office holder in lieu of criminal proceedings
for an offense that does not require proof of criminal intent; or (iii) in connection with a monetary sanction; |
| • |
a monetary liability imposed on the office holder in favor of a payment for a breach offended at an Administrative Procedure (as
defined below) as set forth in Section 52(54)(a)(1)(a) to the Securities Law; |
| • |
expenses expended by the office holder with respect to an Administrative Procedure under the Securities Law, including reasonable
litigation expenses and reasonable attorneys’ fees; |
| • |
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or which were imposed on the office
holder by a court (i) in a proceeding instituted against him or her by the company, on its behalf, or by a third party, (ii) in connection
with criminal indictment of which the office holder was acquitted, or (iii) in a criminal indictment which the office holder was convicted
of an offense that does not require proof of criminal intent; and |
| • |
any other obligation or expense in respect of which it is permitted or will be permitted under applicable law to indemnify an office
holder, including, without limitation, matters referenced in Section 56H(b)(1) of the Securities Law. |
An “Administrative Procedure” is defined as a procedure
pursuant to chapters H3 (Monetary Sanction by the Israeli Securities Authority), H4 (Administrative Enforcement Procedures of the Administrative
Enforcement Committee) or I1 (Arrangement to prevent Procedures or Interruption of procedures subject to conditions) to the Securities
Law.
Under the Companies Law and the Securities Law, a company may insure
an office holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent
provided in the company’s articles of association:
| • |
a breach of the fiduciary duty to the company, provided that the office holder acted in good faith and had a reasonable basis to
believe that the act would not harm the company; |
| • |
a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the
office holder; |
| • |
a monetary liability imposed on the office holder in favor of a third party; |
| • |
a monetary liability imposed on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section
52(54)(a)(1)(a) of the Securities Law; and |
| • |
expenses incurred by an office holder in connection with an Administrative Procedure, including reasonable litigation expenses and
reasonable attorneys’ fees. |
101
Under the Companies Law, a company may not indemnify, exculpate
or insure an office holder against any of the following:
| • |
a breach of the fiduciary duty, except for indemnification and insurance for a breach of the fiduciary duty to the company to the
extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;
|
| • |
a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office
holder; |
| • |
an act or omission committed with intent to derive illegal personal benefit; or |
| • |
a fine or forfeit levied against the office holder. |
Under the Companies Law, exculpation, indemnification and insurance
of office holders must be approved by the compensation committee and the board of directors and, with respect to directors or controlling
shareholders, their relatives and third parties in which controlling shareholders have a personal interest, also by the shareholders.
Our amended and restated articles of association permit us to exculpate,
indemnify and insure our office holders to the fullest extent permitted or to be permitted by law. Our office holders are currently covered
by a directors’ and officers’ liability insurance policy. As of the date of this annual report, no claims for directors’
and officers’ liability insurance have been filed under this policy and we are not aware of any pending or threatened litigation
or proceeding involving any of our office holders, including our directors, in which indemnification is sought.
See "Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions
- Directors and Officers Insurance Policy and Indemnification Agreements" for information regarding letters of indemnification to directors
and officers of the Company.
D.
Employees
As of December 31, 2024, we had 34 employees, all of whom are located
in Israel.
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As of December 31, |
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2023 |
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2024 |
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Company |
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Company |
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Employees |
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Consultants |
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Employees |
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Consultants |
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Management |
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8 |
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8 |
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Research and development and other |
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28 |
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26 |
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While none of our employees are party to a collective bargaining
agreement, certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and
the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations) are applicable to our employees by
order of the Israel Ministry of Labor. These provisions primarily concern the length of the workday, minimum daily wages for professional
workers, pension fund benefits for all employees, insurance for work-related accidents, procedures for dismissing employees, determination
of severance pay and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the
required minimums.
We have never experienced any employment-related work stoppages
and believe our relationship with our employees is good.
102
E.
Share Ownership
For information regarding the share ownership of our directors
and executive officers, please see “Item 7. Major Shareholders and Related Party Transactions – A. Major Shareholders.”
Award Plans
2014 Share Incentive Plan and 2024 Share
Incentive Plan
On December 2, 2014, we adopted the 2014 Share Incentive Plan,
or the 2014 Plan, and, in connection with our initial public offering, we amended and restated the Plan which became effective immediately
after the pricing of our initial public offering. On November 4, 2024, our shareholders approved the adoption of the 2024 Share Incentive
Plan, or the 2024 Plan, and together with the 2014 Plan collectively, the Plan. The Plan is intended to afford an incentive to our
and any of our affiliate’s employees, directors, officers, consultants, advisors and any other person or entity who provides services
to the Company, to continue as service providers, to increase their efforts on our and our affiliates behalf and to promote our success,
by providing such persons with opportunities to acquire a proprietary interest in us.
The number of shares that may be issued under the Plan is
subject to adjustment if particular capital changes affect our share capital or such other number as our board of directors may determine
from time to time. ordinary shares subject to outstanding awards under the Plan that subsequently expire, are cancelled, forfeited or
terminated for any reason before being exercised will be automatically, and without any further action, returned to the “pool”
of reserved shares and will again be available for grant under the Plan. As of April 1, 2025, we had an aggregate of 778,026 ordinary
shares available for issuance under the 2024 Plan (including ordinary shares underlying outstanding options and restricted share units).
A share option is the right to purchase a specified number of ordinary
shares in the future at a specified exercise price and subject to the other terms and conditions specified in the option agreement and
the Plan. The exercise price of each share option granted under the Plan will be determined in accordance with the limitations set forth
under the Plan. The exercise price of any share options granted under the Plan may be paid in cash, through the surrender of ordinary
shares by the option holder or any other method that may be approved by our compensation committee, which may include procedures for cashless
exercise.
Our compensation committee may also grant, or recommend that our
board of directors grant, other forms of equity incentive awards under the Plan, such as restricted shares, restricted share units, and
other forms of share-based compensation.
Israeli participants in the Plan may be granted options subject
to Section 102 of the Israeli Income Tax Ordinance (New Version), 1961, or the Israeli Tax Ordinance. Section 102 of the Israeli Tax Ordinance
allows employees, directors and officers who are not controlling shareholders (as defined for those purposes under the Israeli Tax Ordinance)
and are considered Israeli residents to receive favorable tax treatment for compensation in the form of shares or options. Our non-employee
service providers and controlling shareholders may only be granted options under another section of the Israeli Tax Ordinance, which does
not provide for similar tax benefits. Section 102 includes two alternatives for tax treatment involving the issuance of options or shares
to a trustee for the benefit of the grantees and also includes an additional alternative for the issuance of options or shares directly
to the grantee. The most favorable tax treatment for the grantees is under Section 102(b)(2) of the Israeli Tax Ordinance, the issuance
to a trustee under the “capital gain track.” However, under this track we are not allowed to deduct an expense with respect
to the issuance of the options or shares.
In addition, any options granted under the Plan to participants
in the United States will be either “incentive stock options,” which may be eligible for special tax treatment under the Code,
or options other than incentive stock options (referred to as “nonqualified stock options” under the Plan). The type of option
granted under the Plan and specific terms and conditions are, in each case, determined by our compensation committee or our board of directors
and set forth in the applicable option agreement.
103
Our compensation committee will administer the Plan, or if determined
otherwise by our board of directors, the Plan will be administered by our board of directors or other designated committee on its behalf.
Even if the compensation committee or any other committee was appointed by our board of directors in order to administrate the Plan, our
board of directors may, subject to any legal limitations, exercise any powers or duties of the compensation committee or any other committee
concerning the Plan. The compensation committee will, among others, select which eligible persons will receive options or other awards
under the Plan and will determine, or recommend to our board of directors, the number of ordinary shares covered by those options or other
awards, the terms under which such options or other awards may be exercised (however, options generally may not be exercised later than
ten years from the grant date of an option) or may be settled or paid, and the other terms and conditions of such options and other awards
under the Plan. All awards granted under the Plan shall not be transferable other than by will or by the laws of descent and distribution,
unless otherwise determined by our compensation committee.
To the extent permitted under applicable law, our compensation committee will have the authority to accelerate the vesting of any outstanding
awards at such time and under such circumstances as it, in its sole discretion, deems appropriate. In the event of a change of control,
as defined in the Plan, any award then outstanding shall be assumed or an equivalent award shall be substituted by the successor corporation
of the merger or sale or any parent or affiliate thereof as determined by our board of directors. In the event that the awards are not
assumed or substituted, our compensation committee may, in its discretion, accelerate the vesting, exercisability of the outstanding award,
or provide for the cancellation of such award and payment of cash, as determined to be fair in the circumstances.
Subject to particular limitations specified in the Plan and under
applicable law, our board of directors may amend or terminate the Plan, and the compensation committee may amend awards outstanding under
the Plan. In addition, an amendment to the Plan that requires shareholder approval under applicable law will not be effective unless approved
by the requisite vote of shareholders. In addition, in general, no suspension, termination, modification or amendment of the Plan may
adversely affect any award previously granted without the written consent of grantees holding a majority in interest of the awards so
affected. The Plan will continue in effect until all ordinary shares available under the Plan are delivered and all restrictions on those
shares have lapsed, unless the Plan is terminated earlier by our board of directors. No awards may be granted under the Plan on or after
the tenth anniversary of the date of adoption of the plan unless our board of directors chooses to extend the term.
Any equity award to an office holder, director or controlling
shareholder, whether under the Plan or otherwise, may be subject to further approvals in addition to the approval of the compensation
committee as described above. As of December 31, 2024, options to purchase 2,176,079 ordinary shares, at a weighted average exercise
price of $3.78 per share, were outstanding under our Plan.
F. Disclosure
of a registrant’s action to recover erroneously awarded compensation
None.
ITEM 7.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A.
Major Shareholders
The following table sets forth information with respect to the
beneficial ownership of our ordinary shares as of April 1, 2025 by:
| • |
each person or entity known by us to own beneficially 5% or more of our outstanding ordinary shares; |
| • |
each of our directors, executive officers and director nominees; and |
| • |
all of our executive officers, directors and director nominees as a group. |
The beneficial ownership of our ordinary shares is determined in accordance with the
rules of the SEC. Under these rules, a person is deemed to be a beneficial owner of a security if that person has or shares voting power,
which includes the power to vote or to direct the voting of the security, or investment power, which includes the power to dispose of
or to direct the disposition of the security. For purposes of the table below, we deem ordinary shares issuable pursuant to options that
are currently exercisable or exercisable within 60 days as of April 1, 2025, if any, to be outstanding and to be beneficially owned by
the person holding the options or warrants for the purposes of computing the percentage ownership of that person, but we do not treat
them as outstanding for the purpose of computing the percentage ownership of any other person. The percentage of ordinary shares beneficially
owned is based on 27,857,620 ordinary shares outstanding as of April 1, 2025.
104
Except
where otherwise indicated, we believe, based on information furnished to us by such owners, that the beneficial owners of the ordinary
shares listed below have sole investment and voting power with respect to such shares.
None of our shareholders has different voting rights from other
shareholders. We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company.
Unless otherwise noted below, the address for each beneficial owner
is c/o Sol-Gel Technologies Ltd., 7 Golda Meir St., Weizmann Science Park, Ness Ziona, 7403650 Israel.
|
|
Shares Beneficially
Owned |
|||||||
|
Name of Beneficial Owner |
Number |
Percentage |
||||||
|
5% or greater shareholders |
||||||||
|
M. Arkin Dermatology Ltd. (1) |
18,227,792 |
61.04 |
% | |||||
|
Phoenix Holdings Ltd. (2) |
2,470,192 |
8.87 | % | |||||
|
|
||||||||
|
Directors and executive officers |
||||||||
|
Moshe Arkin (1) |
18,313,792 |
61.34 | % | |||||
|
Eyal Ben-Or |
||||||||
|
Ofer Toledano |
* |
* |
||||||
|
Ofra Levy-Hacham |
* |
* |
||||||
|
Itzik Yosef |
* |
* |
||||||
|
Michael Glezin |
||||||||
|
Tamar Fishman Jutkowitz |
* |
* |
||||||
|
Itai Arkin |
* |
* |
||||||
|
Ran Gottfried |
* |
* |
||||||
|
Hanna Lerman |
* |
* |
||||||
|
Sharon G. Kochan |
* |
* |
||||||
|
Yuval Yanai |
* |
* |
||||||
|
All directors and executive
officers as a group (12 persons) |
19,789,335
|
63.24 |
% | |||||
|
* Less than 1%. |
| (1) |
Arkin Dermatology directly owns 16,227,792 ordinary shares and
2,000,000 warrants to purchase up to 2,000,000 ordinary shares. Mr. Moshe Arkin, the executive chairman of our board of directors, is
the sole shareholder and sole director of Arkin Dermatology and may therefore be deemed to be the indirect beneficial owner of the ordinary
shares owned directly by Arkin Dermatology. In addition, Mr. Moshe Arkin directly owns 86,000 ordinary shares. |
| (2) |
Based on the Schedule 13G/A filed with the SEC on November 14, 2024, the ordinary shares are beneficially owned by various direct
or indirect, majority or wholly-owned subsidiaries of the Phoenix Holding Ltd., or the Subsidiaries. The Subsidiaries manage their
own funds and/or the funds of others, including for holders of exchange-traded notes or various insurance policies, members of pension
or provident funds, unit holders of mutual funds, and portfolio management clients. Each of the Subsidiaries operates under independent
management and makes its own independent voting and investment decisions. |
| (3) |
Includes options to purchase 1,435,743 ordinary shares exercisable within
60 days of March 1, 2025. The exercise price of these options ranges between $0.8342 and $11.21 per share and the options expire
between August 2026 and February 2035. |
105
Record Holders
As of April 15, 2025, we had one holder of record of our ordinary
shares in the United States, consisting of Cede & Co., the nominee of The Depository Trust Company. That shareholder held, in the
aggregate, 13,667,923 ordinary shares, representing approximately 49.0% of the outstanding ordinary shares as of April 1,
2025. The number of record holders in the United States is not representative of the number of beneficial holders nor is it representative
of where such beneficial holders are resident since many of these ordinary shares were held by brokers or other nominees.
B.
Related Party Transactions
Private Placement with Our Controlling Shareholder
On January 27, 2023, we entered into subscription agreement with
Arkin Dermatology Ltd., pursuant to which Arkin Dermatology Ltd. agreed to purchase 2,000,000 unregistered ordinary shares and unregistered
warrants to purchase up to 2,000,000 ordinary shares in a concurrent private placement exempt from the registration of the Securities
Act, at a price equal to the offering price of the ordinary shares in the January 2023 registered direct offering. Each of the warrants
issued to Arkin Dermatology is exercisable for one ordinary share, has an initial exercise price of $5.85 per share, is exercisable
beginning six months from the date of issuance and will expire on January 27, 2028 and is subject to certain adjustments. This
private placement closed in April 2023 following shareholder approval.
Directors and Officers Insurance Policy and Indemnification
Agreements
Our amended and restated articles of association permit us to
exculpate, indemnify and insure each of our directors and officers to the fullest extent permitted by the Companies Law. We have obtained
Directors and Officers insurance for each of our executive officers and directors. For further information, see “Item 6 C. –
Board Practices – Exculpation, Insurance and Indemnification of Directors and Officers”.
We entered into agreements with each of our current directors and
officers exculpating them from a breach of their duty of care to us to the fullest extent permitted by law, subject to limited exceptions,
and undertaking to indemnify them to the fullest extent permitted by law, subject to limited exceptions, including, with respect to liabilities
resulting from our initial public offering, to the extent that these liabilities are not covered by insurance. This indemnification is
limited, with respect to any monetary liability imposed in favor of a third party, to events determined as foreseeable by the board of
directors based on our activities. The maximum aggregate amount of indemnification that we may pay to our directors and officers based
on such indemnification agreement is the greater of (1) 25% of our shareholders’ equity pursuant to our audited financial statements
for the year preceding the year in which the event in connection of which indemnification is sought occurred, and (2) $40 million (as
may be increased from time to time by shareholders’ approval). Such indemnification amounts are in addition to any insurance amounts.
Each director or officer who agrees to receive this letter of indemnification also gives his approval to the termination of all previous
letters of indemnification that we have provided to him or her in the past, if any.
Registration Rights Agreement
We were party to a registration rights agreement, pursuant to which
we granted demand registration rights, short-form registration rights and piggyback registration rights to Arkin Dermatology, our controlling
shareholder. All fees, costs and expenses of underwritten registrations are expected to be borne by us. This registration rights
agreement expired on February 5, 2023. At a special shareholder meeting held on March 30, 2023, our shareholders approved the renewal
of the registration rights agreement on substantially the same terms as the agreement that expired.
C.
Interests of Experts and Counsel
Not applicable.
106
ITEM 8.
FINANCIAL INFORMATION
A.
Financial Statements and Other Financial Information
The financial statements required by this item are found at the
end of this annual report, beginning on page F-2.
Legal Proceedings
We are not currently a party to any material legal proceedings.
Dividend Policy
We have never declared or paid any cash dividends on our ordinary
shares and we anticipate that, for the foreseeable future, we will retain any future earnings to support operations and to finance the
growth and development of our business. Therefore, we do not expect to pay cash dividends for at least the next several years.
The distribution of dividends may also be limited by the Companies
Law, which permits the distribution of dividends only out of retained earnings or earnings derived over the two most recent fiscal years,
whichever is higher, provided that there is no reasonable concern that payment of a dividend will prevent a company from satisfying its
existing and foreseeable obligations as they become due. Our amended and restated articles of association provide that dividends will
be paid at the discretion of, and upon resolution by, our board of directors, subject to the provisions of the Companies Law.
B.
Significant Changes
Except as otherwise disclosed in this annual report, no significant
change has occurred since December 31, 2024.
ITEM 9. THE OFFER AND LISTING
A.
Offer and Listing Details
Our ordinary shares have been trading on The Nasdaq Capital Market
under the symbol “SLGL” since November 15, 2024 and on The Nasdaq Global Market from February 1, 2018 to November 14, 2024.
Prior to that date, there was no public trading market for our ordinary shares. Our initial public offering was priced at $12.00 per share
on January 31, 2018.
107
B. Plan of Distribution
Not applicable.
C.
Markets
Our Ordinary shares are listed and traded on The Nasdaq Capital
Market under the symbol “SLGL”.
D.
Selling Shareholders
Not applicable.
E.
Dilution
Not applicable.
F.
Expenses of the Issue
Not applicable.
ITEM 10.
ADDITIONAL INFORMATION
A.
Share Capital
Not applicable.
B. Memorandum and Articles
of Association
Registration Number and Purposes of the Company
Our registration number with the Israeli Registrar of Companies
is 51-254469-3. Our purpose as set forth in our amended and restated articles of association is to engage in any lawful activity.
108
Voting Rights and Conversion
All ordinary shares will have identical voting and other rights
in all respects.
Transfer of Shares
Our fully paid ordinary shares are issued in registered form and
may be freely transferred under our amended and restated articles of association, unless the transfer is restricted or prohibited by another
instrument, applicable law or the rules of a stock exchange on which the shares are listed for trade. The ownership or voting of our ordinary
shares by non-residents of Israel is not restricted in any way by our amended and restated articles of association or the laws of the
State of Israel, except for ownership by nationals of some countries that are, or have been, in a state of war with Israel.
Liability to Further Capital Calls
Our board of directors may make, from time to time, such calls
as it may deem fit upon shareholders with respect to any sum unpaid with respect to shares held by such shareholders which is not payable
at a fixed time. Such shareholder shall pay the amount of every call so made upon him. Unless otherwise stipulated by the board of directors,
each payment in response to a call shall be deemed to constitute a pro rata payment on account of all shares with respect to which such
call was made. A shareholder shall not be entitled to his rights as shareholder, including the right to dividends, unless such shareholder
has fully paid all the notices of call delivered to him, or which according to our amended and restated articles of association are deemed
to have been delivered to him, together with interest, linkage and expenses, if any, unless otherwise determined by the board of directors.
Election of Directors
Our ordinary shares do not have cumulative voting rights for the
election of directors. As a result, the holders of a majority of the voting power represented at a shareholders meeting have the power
to elect all of our directors, subject to the special approval requirements for external directors under the Companies Law described under
“Management — External Directors.”
Under our amended
and restated articles of association, our board of directors must consist of not less than five (5) but no more than ten (10) directors,
including any external directors required to be appointed by the Companies Law. Pursuant to our amended and restated articles of association,
other than the external directors, for whom special election requirements apply under the Companies Law, the vote required to appoint
a director is a simple majority vote of holders of our voting shares participating and voting at the relevant meeting. In addition, our
amended and restated articles of association allow our board of directors to appoint new directors to fill vacancies on the board of directors
if the number of directors is below the maximum number provided in our amended and restated articles. Furthermore, under our amended and
restated articles of association, we have only one class of directors. For a more detailed description on the composition of our board
of election procedures of our directors, other than our external directors, see “Item 6. Directors, Senior Management and Employees
— C. Board Practices — Appointment of Directors and Terms of Officers.” External directors are elected for an initial
term of a year, and may be elected for additional terms of a year except in the case of external directors whose terms of office are governed
by the Israeli Companies Law, and may be removed from office pursuant to the terms of the Companies Law. For further information on the
election and removal of external directors, see “Item 6. Directors, Senior Management and Employees — C. Board Practices —
External Directors — Election and Dismissal of External Directors.”
Dividend and Liquidation Rights
We may declare a dividend to be paid to the holders of our ordinary
shares in proportion to their respective shareholdings. Under the Companies Law, dividend distributions are determined by the board of
directors and do not require the approval of the shareholders of a company unless the company’s articles of association provide
otherwise. Our amended and restated articles of association do not require shareholder approval of a dividend distribution and provide
that dividend distributions may be determined by our board of directors.
Pursuant to the Companies Law, subject to certain exceptions with
respect to the buyback by the Company of its ordinary shares, the distribution amount is limited to the greater of retained earnings or
earnings generated over the previous two years, according to our then last reviewed or audited financial statements, provided that the
date of the financial statements is not more than six months prior to the date of the distribution, or we may distribute dividends that
do not meet such criteria only with court approval. In each case, we are only permitted to distribute a dividend if our board of directors
and the court, if applicable, determines that there is no reasonable concern that payment of the dividend will prevent us from satisfying
our existing and foreseeable obligations as they become due.
In the event of our liquidation, after satisfaction of liabilities
to creditors, our assets will be distributed to the holders of our ordinary shares in proportion to their shareholdings. This right, as
well as the right to receive dividends, may be affected by the grant of preferential dividend or distribution rights to the holders of
a class of shares with preferential rights that may be authorized in the future.
109
Shareholder Meetings
Under Israeli law, we are required to hold an annual general
meeting of our shareholders once every calendar year that must be held no later than 15 months after the date of the previous annual general
meeting. All general meetings other than the annual meeting of shareholders are referred to in our amended and restated articles of association
as special meetings. Our board of directors may call special meetings whenever it sees fit, at such time and place, within or outside
of Israel, as it may determine. In addition, Israeli law provides that our board of directors is required to convene a special meeting
upon the written request of (i) any two of our directors or one-quarter of the members of our board of directors or (ii) one or
more shareholders holding, in the aggregate, either (a) 10% or more of our outstanding issued shares and 1% or more of our outstanding
voting power or (b) 10% or more of our outstanding voting power.
Under Israeli law, one or more shareholders holding at least
1% of the voting rights at the general meeting may request that the board of directors include a matter in the agenda of a general meeting
to be convened in the future, provided that it is appropriate to discuss such a matter at the general meeting. Notwithstanding the
foregoing, one or more shareholders holding at least 5% of the voting rights at a general meeting of shareholders may request that our
board of directors include a proposal that relates to the election or removal of a director in the agenda of a general meeting of shareholders
to be convened in the future.
Subject to the provisions of the Companies Law and the regulations
promulgated thereunder, shareholders entitled to participate and vote at general meetings are the shareholders of record on a date to
be decided by the board of directors, which may be between four and 60 days prior to the date of the meeting. Furthermore, the Companies
Law requires that resolutions regarding the following matters must be passed at a general meeting of our shareholders:
| • |
amendments to our amended and restated articles of association; |
| • |
appointment or termination of our auditors; |
| • |
appointment of external directors; |
| • |
approval of certain related party transactions; |
| • |
increases or reductions of our authorized share capital; |
| • |
mergers; and |
| • |
the exercise of our board of director’s powers by a general meeting, if our board of directors is unable to exercise its powers
and the exercise of any of its powers is required for our proper management. |
Under our amended and restated articles of association, we are
not required to give notice to our registered shareholders pursuant to the Companies Law, unless otherwise required by law. The Companies
Law requires that a notice of any annual general meeting or special general meeting be provided to shareholders at least 21 days prior
to the meeting and if the agenda of the meeting includes the appointment or removal of directors, the approval of transactions with office
holders or interested or related parties, or an approval of a merger, or as otherwise required under applicable law, notice must be provided
at least 35 days prior to the meeting. Under the Companies Law, shareholders are not permitted to take action by written consent in lieu
of a meeting. Our amended and restated articles of association provide that a notice of general meeting shall be published by us on Form
6-K at a date prior to the meeting as required by law.
110
Voting Rights
Quorum Requirements
Pursuant to our amended and restated articles of association, holders
of our ordinary shares have one vote for each ordinary share held on all matters submitted to a vote before the shareholders at a general
meeting. Under our amended and restated articles of association, the quorum required for general meetings of shareholders must consist
of at least two shareholders present in person or by proxy (including by voting deed) holding 33 1∕3% or more of the voting rights
in the Company, which complies with the quorum requirements for general meetings under the Nasdaq Marketplace Rules. A meeting adjourned
for lack of a quorum will generally be adjourned to the same day of the following week at the same time and place, or to such other day,
time or place as indicated by our board of directors if so specified in the notice of the meeting. At the reconvened meeting, any number
of shareholders present in person or by proxy shall constitute a lawful quorum, instead of 33 1∕3% of the issued share capital as
required under the Nasdaq Marketplace Rules.
Vote Requirements
Our amended and restated articles of association provide that all
resolutions of our shareholders require a simple majority vote, unless otherwise required by the Companies Law or by our amended and restated
articles of association. Pursuant to our amended and restated articles of association, an amendment to our amended and restated articles
of association regarding any change of the composition or election procedures of our directors will require a special majority vote (66-2∕3%).
Under the Companies Law, each of (i) the approval of an extraordinary transaction with a controlling shareholder and (ii) the terms
of employment or other engagement of the controlling shareholder of the company or such controlling shareholder’s relative (even
if not extraordinary) requires the approval described above under “Management — Fiduciary Duties and Approval of Specified
Related Party Transactions and Compensation under Israeli Law — Disclosure of Personal Interests of a Controlling Shareholder and
Approval of Transactions.” Certain transactions with respect to remuneration of our office holders and directors require further
approvals described above under “Management — Fiduciary Duties and Approval of Specified Related Party Transactions and Compensation
under Israeli Law — Compensation of Directors and Executive Officers.” Under our amended and restated articles of association,
any change to the rights and privileges of the holders of any class of our shares requires a simple majority of the class so affected
(or such other percentage of the relevant class that may be set forth in the governing documents relevant to such class), in addition
to the ordinary majority vote of all classes of shares voting together as a single class at a shareholder meeting. Another exception to
the simple majority vote requirement is a resolution for the voluntary winding up, or an approval of a scheme of arrangement or reorganization,
of the company pursuant to Section 350 of the Companies Law, which requires the approval of holders of 75% of the voting rights represented
at the meeting, in person, by proxy or by voting deed and voting on the resolution.
Access to Corporate Records
Under the Companies Law, shareholders are provided access to minutes
of our general meetings, our shareholders register and principal shareholders register, our amended and restated articles of association,
our financial statements and any document that we are required by law to file publicly with the Israeli Companies Registrar or the Israel
Securities Authority. In addition, shareholders may request to be provided with any document related to an action or transaction requiring
shareholder approval under the related party transaction provisions of the Companies Law. We may deny this request if we believe it has
not been made in good faith or if such denial is necessary to protect our interest or protect a trade secret or patent.
Modification of Class Rights
Under the Companies Law and our amended and restated articles of
association, the rights attached to any class of share, such as voting, liquidation and dividend rights, may be amended by adoption of
a resolution by the holders of a majority of the shares of that class present at a separate class meeting, or otherwise in accordance
with the rights attached to such class of shares, in addition to the ordinary majority vote of all classes of shares voting together as
a single class at a shareholder meeting, as set forth in our amended and restated articles of association.
Registration Rights
For a discussion of registration rights we granted to our controlling
shareholder please see “Item 7. Major Shareholders and Related Party Transactions – Related Party Transactions — Registration
Rights Agreement.”
111
Acquisitions under Israeli Law
Full Tender Offer
A person wishing to acquire shares of an Israeli public company
and who would as a result hold over 90% of the target company’s issued and outstanding share capital is required by the Companies
Law to make a tender offer to all of the company’s shareholders for the purchase of all of the issued and outstanding shares of
the company. A person wishing to acquire shares of a public Israeli company and who would as a result hold over 90% of the issued and
outstanding share capital of a certain class of shares is required to make a tender offer to all of the shareholders who hold shares of
the relevant class for the purchase of all of the issued and outstanding shares of that class. If the shareholders who do not accept the
offer hold less than 5% of the issued and outstanding share capital of the company or of the applicable class, and more than half of the
shareholders who do not have a personal interest in the offer accept the offer, all of the shares that the acquirer offered to purchase
will be transferred to the acquirer by operation of law. However, a tender offer will also be accepted if the shareholders who do not
accept the offer hold less than 2% of the issued and outstanding share capital of the company or of the applicable class of shares.
Upon a successful completion of such a full tender offer, any shareholder
that was an offeree in such tender offer, whether such shareholder accepted the tender offer or not, may, within six months from the date
of acceptance of the tender offer, petition an Israeli court to determine whether the tender offer was for less than fair value and that
the fair value should be paid as determined by the court. However, under certain conditions, the offeror may include in the terms of the
tender offer that an offeree who accepted the offer will not be entitled to petition the Israeli court as described above.
If (a) the shareholders who did not respond or accept the
tender offer hold at least 5% of the issued and outstanding share capital of the company or of the applicable class or the shareholders
who accept the offer constitute less than a majority of the offerees that do not have a personal interest in the acceptance of the tender
offer, or (b) the shareholders who did not accept the tender offer hold 2% or more of the issued and outstanding share capital of the
company (or of the applicable class), the acquirer may not acquire shares of the company that will increase its holdings to more than
90% of the company’s issued and outstanding share capital or of the applicable class from shareholders who accepted the tender offer.
Special Tender Offer
The Companies Law provides that an acquisition of shares of an
Israeli public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a
holder of 25% or more of the voting rights in the company. This requirement does not apply if there is already another holder of at least
25% of the voting rights in the company. Similarly, the Companies Law provides that an acquisition of shares in a public company must
be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of more than 45% of the
voting rights in the company, if there is no other shareholder of the company who holds more than 45% of the voting rights in the company,
subject to certain exceptions.
A special tender offer must be extended to all shareholders of
a company but the offeror is not required to purchase shares representing more than 5% of the voting power attached to the company’s
outstanding shares, regardless of how many shares are tendered by shareholders. A special tender offer may be consummated only if
(i) at least 5% of the voting power attached to the company’s outstanding shares will be acquired by the offeror and (ii) the number
of shares tendered in the offer exceeds the number of shares whose holders objected to the offer (excluding the purchaser and its controlling
shareholder, holders of 25% or more of the voting rights in the company or any person having a personal interest in the acceptance of
the tender offer or any other person acting on their behalf, including relatives and entities under such person’s control). If a
special tender offer is accepted, then the purchaser or any person or entity controlling it or under common control with the purchaser
or such controlling person or entity may not make a subsequent tender offer for the purchase of shares of the target company and may not
enter into a merger with the target company for a period of one year from the date of the offer, unless the purchaser or such person or
entity undertook to effect such an offer or merger in the initial special tender offer.
112
Merger
The Companies Law permits merger transactions if approved by each
party’s board of directors and, unless certain requirements described under the Companies Law are met, by a majority vote of each
party’s shares, and, in the case of the target company, a majority vote of each class of its shares voted on the proposed merger
at a shareholders meeting.
For purposes of the shareholder vote, unless a court rules otherwise,
the merger will not be deemed approved if a majority of the votes of the shares represented at the shareholders meeting that are held
by parties other than the other party to the merger, or by any person (or group of persons acting in concert) who holds (or hold, as the
case may be) 25% or more of the voting rights or the right to appoint 25% or more of the directors of the other party, vote against the
merger. If, however, the merger involves a merger with a company’s own controlling shareholder or if the controlling shareholder
has a personal interest in the merger, then the merger is instead subject to the same special majority approval that governs all extraordinary
transactions with controlling shareholders (as described under “Management — Fiduciary Duties and Approval of Specified Related
Party Transactions and Compensation under Israeli Law — Disclosure of Personal Interests of a Controlling Shareholder and Approval
of Transactions”).
If the transaction would have been approved by the shareholders
of a merging company but for the separate approval of each class or the exclusion of the votes of certain shareholders as provided above,
a court may still approve the merger upon the request of holders of at least 25% of the voting rights of a company, if the court holds
that the merger is fair and reasonable, taking into account the value to the parties to the merger and the consideration offered to the
shareholders of the company.
Upon the request of a creditor of either party to the proposed
merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that, as a result of the merger,
the surviving company will be unable to satisfy the obligations of the merging entities, and may further give instructions to secure the
rights of creditors.
In addition, a merger may not be consummated unless at least 50
days have passed from the date on which a proposal for approval of the merger was filed by each party with the Israeli Registrar of Companies
and at least 30 days have passed from the date on which the merger was approved by the shareholders of each party.
Anti-Takeover Measures under Israeli
Law
The Companies Law allows us to create and issue shares having rights
different from those attached to our ordinary shares, including shares providing certain preferred rights with respect to voting, distributions
or other matters and shares having preemptive rights. As of the date of this annual report, no preferred shares are authorized under our
amended and restated articles of association. In the future, if we do authorize, create and issue a specific class of preferred shares,
such class of shares, depending on the specific rights that may be attached to it, may have the ability to frustrate or prevent a takeover
or otherwise prevent our shareholders from realizing a potential premium over the market value of their ordinary shares. The authorization
and designation of a class of preferred shares will require an amendment to our amended and restated articles of association, which requires
the prior approval of the holders of a majority of the voting power attaching to our issued and outstanding shares at a general meeting.
The convening of the meeting, the shareholders entitled to participate and the majority vote required to be obtained at such a meeting
will be subject to the requirements set forth in the Companies Law as described above in “— Voting Rights.”
Borrowing Powers
Pursuant to the Companies Law and our amended and restated articles
of association, our board of directors may exercise all powers and take all actions that are not required under law or under our amended
and restated articles of association to be exercised or taken by our shareholders, including the power to borrow money for company purposes.
Changes in Capital
Our amended and restated articles of association enable us to increase
or reduce our share capital. Any such changes are subject to the provisions of the Companies Law and must be approved by a resolution
duly adopted by our shareholders at a general meeting. In addition, transactions that have the effect of reducing capital, such as the
declaration and payment of dividends in the absence of sufficient retained earnings or profits, require the approval of both our board
of directors and an Israeli court.
113
Transfer Agent and Registrar
The transfer agent and registrar for our ordinary shares is Equiniti Trust
Company, LLC.
C.
Material Contracts
For a description of other material agreements, please see "Item
4. Information on the Company – B. Business Overview."
D.
Exchange Controls
There are currently no Israeli currency control restrictions on
remittances of dividends on our ordinary shares, proceeds from the sale of the shares or interest or other payments to non-residents of
Israel, except for shareholders who are subjects of certain countries that are considered to be in a state of war with Israel at such
time.
E.
Taxation
Israeli Tax Considerations and Government Programs
General
The following is a summary of the material Israeli tax laws applicable
to us, and some Israeli Government programs benefiting us. This section also contains a discussion of some Israeli tax consequences to
persons owning our ordinary shares. This summary does not discuss all the aspects of Israeli tax law that may be relevant to a particular
investor in light of his or her personal investment circumstances or to some types of investors subject to special treatment under Israeli
law. Examples of this kind of investor include traders in securities or persons that own, directly or indirectly, 10% or more of our outstanding
voting capital, all of whom are subject to special tax regimes not covered in this discussion. Some parts of this discussion are based
on new tax legislation which has not been subject to judicial or administrative interpretation. The discussion should not be construed
as legal or professional tax advice and does not cover all possible tax considerations.
SHAREHOLDERS ARE URGED TO CONSULT THEIR OWN TAX ADVISORS AS TO
THE ISRAELI OR OTHER TAX CONSEQUENCES OF THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR ORDINARY SHARES, INCLUDING, IN PARTICULAR, THE
EFFECT OF ANY FOREIGN, STATE OR LOCAL TAXES.
General Corporate Tax Structure in Israel
Israeli resident companies are generally subject to corporate tax
at the rate of 23% in 2024. However, the effective tax rate payable by a company that derives income from a Benefited Enterprise or a
Preferred Enterprise (as discussed below) may be considerably less. Capital gains derived by an Israeli resident company are subject to
tax at the prevailing corporate tax rate.
Under Israeli tax legislation, a corporation will be considered
as an “Israeli resident company” if it meets one of the following: (i) it was incorporated in Israel; or (ii) the control
and management of its business are exercised in Israel.
114
Law for the Encouragement of Industry (Taxes), 5729-1969
The Law for the Encouragement of Industry (Taxes), 5729-1969, generally
referred to as the Industry Encouragement Law, provides several tax benefits for “Industrial Companies.”
The Industry Encouragement Law defines an “Industrial Company”
as a company resident in Israel and which was incorporated in Israel of which 90% or more of its income in any tax year, other than certain
income (such as from defense loans, capital gains, interest and dividends) is derived from an “Industrial Enterprise” owned
by it and which is located in Israel or in the “Area” (as defined under Section 3A of the Israeli Tax Ordinance). An “Industrial
Enterprise” is defined as an enterprise whose principal activity in a given tax year is industrial production.
The following corporate tax benefits, among others, are available
to Industrial Companies:
| • |
amortization over an eight-year period of the cost of purchased know-how and patents and rights to use a patent and know-how which
were purchased in good faith and are used for the development or advancement of the Industrial Enterprise, commencing on the year
in which they were first used; |
| • |
under limited conditions, an election to file consolidated tax returns with related Israeli Industrial Companies; and |
| • |
expenses related to a public offering are deductible in equal amounts over three years commencing on the year of the offering.
|
Although as of the date of this annual report, we do not have
industrial production activities, we may qualify as an Industrial Company in the future and may be eligible for the benefits described
above.
Tax Benefits and Grants for Research and Development
Israeli tax law allows, under certain conditions, a tax deduction
for expenditures, including capital expenditures, for the year in which they are incurred. Expenditures are deemed related to scientific
research and development projects, if:
| • |
The research and expenditures are approved by the relevant Israeli government ministry, determined by the field of research;
|
| • |
The research and development must be for the promotion of the company; and |
| • |
The research and development are carried out by or on behalf of the company seeking such tax deduction. |
The amount of such deductible expenses is reduced by the sum of
any funds received through government grants for the financing of such scientific research and development projects. No deduction under
these research and development deduction rules is allowed if such deduction is related to an expense invested in an asset depreciable
under the general depreciation rules of the Israeli Tax Ordinance, 1961. Expenditures not so approved are deductible in equal amounts
over three years.
From time to time we may apply to the IIA for approval to allow
a tax deduction for all research and development expenses during the year incurred. There can be no assurance that such application will
be accepted.
Law for the Encouragement of Capital Investments,
5719-1959
The Law for the Encouragement of Capital Investments, 5719-1959,
generally referred to as the Investment Law, provides certain incentives for capital investments in production facilities (or other eligible
assets) by “Industrial Enterprises” (as defined under the Investment Law).
115
Tax Benefits Prior to the 2005 Amendment
An investment program that is implemented in accordance with the
provisions of the Investment Law prior to an amendment that became effective in April 2005, or the 2005 Amendment, referred to as an “Approved
Enterprise,” is entitled to certain benefits. A company that wished to receive benefits as an Approved Enterprise must have received
approval from the Investment Center of the Israeli Ministry of Economy and Industry, or the Investment Center. Each certificate of approval
for an Approved Enterprise relates to a specific investment program in the Approved Enterprise, delineated both by the financial scope
of the investment and by the physical characteristics of the facility or the asset.
In general, an Approved Enterprise is entitled to receive a grant
from the Government of Israel or an alternative package of tax benefits, known as the alternative benefits track. The tax benefits from
any certificate of approval relate only to taxable profits attributable to the specific Approved Enterprise. Income derived from activity
that is not integral to the activity of the Approved Enterprise does not enjoy tax benefits.
In addition, a company that has an Approved Enterprise program
is eligible for further tax benefits if it qualifies as a Foreign Investors’ Company, or FIC, which is a company with a level of
foreign investment, as defined in the Investment Law, of more than 25%. The level of foreign investment is measured as the percentage
of rights in the company (in terms of shares, rights to profits, voting and appointment of directors), and of combined share and loan
capital, that are owned, directly or indirectly, by persons who are not residents of Israel. The determination as to whether a company
qualifies as an FIC is made on an annual basis. We are currently not entitled to tax benefits for Approved Enterprise.
Tax Benefits Subsequent to the 2005 Amendment
The 2005 Amendment applies to new investment programs and investment
programs commencing after 2004, but does not apply to investment programs approved prior to April 1, 2005. The 2005 Amendment provides
that terms and benefits included in any certificate of approval that was granted before the 2005 Amendment became effective (April 1,
2005) will remain subject to the provisions of the Investment Law as in effect on the date of such approval. Pursuant to the 2005 Amendment,
the Investment Center will continue to grant Approved Enterprise status to qualifying investments. The 2005 Amendment, however, limits
the scope of enterprises that may be approved by the Investment Center by setting criteria for the approval of a facility as an Approved
Enterprise, such as provisions generally requiring that at least 25% of the Approved Enterprise’s income be derived from exports.
The 2005 Amendment provides that Approved Enterprise status will
only be necessary for receiving cash grants. As a result, it was no longer necessary for a company to obtain Approved Enterprise status
in order to receive the tax benefits previously available under the alternative benefits track. Rather, a company may claim the tax benefits
offered by the Investment Law directly in its tax returns, provided that its facilities meet the criteria for tax benefits set forth in
the amendment. Companies are entitled to approach the Israeli Tax Authority for a pre-ruling regarding their eligibility for benefits
under the Investment Law, as amended.
In order to receive the tax benefits, the 2005 Amendment states
that a company must make an investment which meets all of the conditions, including exceeding a minimum investment amount specified in
the Investment Law. Such investment allows a company to receive “Benefited Enterprise” status, and may be made over a period
of no more than three years from the end of the year in which the company requested to have the tax benefits apply to its Benefited Enterprise.
Where the company requests to apply the tax benefits to an expansion of existing facilities, only the expansion will be considered to
be a Benefited Enterprise and the company’s effective tax rate will be the weighted average of the applicable rates. In this case,
the minimum investment required in order to qualify as a Benefited Enterprise is required to exceed a certain percentage of the value
of the company’s production assets before the expansion.
The extent of the tax benefits available under the 2005 Amendment
to qualifying income of a Benefited Enterprise depend on, among other things, the geographic location in Israel of the Benefited Enterprise.
The location will also determine the period for which tax benefits are available. Such tax benefits include an exemption from corporate
tax on undistributed income for a period of between two to 10 years, depending on the geographic location of the Benefited Enterprise
in Israel, and a reduced corporate tax rate of between 10% and the applicable corporate tax for the remainder of the benefits period,
depending on the level of foreign investment in the company in each year. A company qualifying for tax benefits under the 2005 Amendment
which pays a dividend out of income derived by its Benefited Enterprise during the tax exemption period will be subject to corporate tax
in respect of the gross amount of the dividend at the otherwise applicable corporate tax rate or a lower rate in the case of a qualified
FIC which is at least 49% owned by non-Israeli residents. Dividends paid out of income attributed to a Benefited Enterprise are generally
subject to withholding tax at source at the rate of 20% or such lower rate as may be provided in an applicable tax treaty.
116
The benefits available to a Benefited Enterprise are subject to
the fulfillment of conditions stipulated in the Investment Law and its regulations. If a company does not meet these conditions, it may
be required to refund the amount of tax benefits, as adjusted by the Israeli consumer price index, and interest, or other monetary penalties.
We applied for tax benefits as a “Benefited Enterprise”
with 2012 as a “Year of Election.” We may be entitled to tax benefits under this regime once we are profitable for tax purposes
and subject to the fulfillment of all the relevant conditions. If we do not meet these conditions, the tax benefits may not be applicable
which would result in adverse tax consequences to us. Alternatively, and subject to the fulfillment of all the relevant conditions, we
may elect in the future to irrevocably waive the tax benefits available for Benefited Enterprise and claim the tax benefits available
to Preferred Enterprise under the 2011 Amendment (as detailed below).
Tax Benefits Under the 2011 Amendment
The Investment Law was significantly amended as of January 1,
2011, or the 2011 Amendment. The 2011 Amendment introduced new benefits to replace those granted in accordance with the provisions of
the Investment Law in effect prior to the 2011 Amendment.
The 2011 Amendment introduced new tax benefits for income generated
by a “Preferred Company” through its “Preferred Enterprise,” in accordance with the definition of such term in
the Investment Law, which generally means that a “Preferred Company” is an industrial company meeting certain conditions (including
a minimum threshold of 25% export).
A Preferred Company is entitled to a reduced flat tax rate with
respect to the income attributed to the Preferred Enterprise, at the following rates:
|
Tax Year |
|
Development Region “A” |
|
|
Other Areas within Israel |
| ||
|
2011 – 2012 |
|
|
10 |
% |
|
|
15 |
% |
|
2013 |
|
|
7 |
% |
|
|
12.5 |
% |
|
2014 – 2016 |
|
|
9 |
% |
|
|
16 |
% |
|
2017 and thereafter |
|
|
7.5 |
% |
|
|
16 |
% |
Dividends distributed from income which is attributed to a “Preferred
Enterprise” will be subject to withholding tax at source at the following rates: (i) Israeli resident corporations — 0%, (ii)
Israeli resident individuals — 20% in 2024 (iii) non-Israeli residents — 20%, which may be reduced down to 4% in 2024, subject
to certain conditions under the Investment Law and to a reduced tax rate under the provisions of an applicable double tax treaty.
Under the 2011 Amendment, a company located in Development Region
“A” may be entitled to cash grants and the provision of loans under certain conditions, if approved. The rates for grants
and loans shall not be fixed, but up to 20% of the amount of the approved investment. In addition, a company owning a Preferred Enterprise
under the Grant Track may be entitled also to the tax benefits which are prescribed for a Preferred Company.
The termination or substantial reduction of any of the benefits
available under the Investment Law could materially increase our tax liabilities.
We are currently not entitled to tax benefits for a Preferred Enterprise.
New Tax benefits under the 2017
Amendment that became effective on January 1, 2017.
The 2017 Amendment was enacted as part of the Economic Efficiency
Law that was published on December 29, 2016, and was effective as of January 1, 2017. The 2017 Amendment provides new tax benefits for
two types of “Technology Enterprises”, as described below, and is in addition to the other existing tax beneficial programs
under the Investment Law.
The 2017 Amendment provides that a Preferred company satisfying
certain conditions will qualify as having a “Preferred Technology Enterprise” and will thereby enjoy a reduced corporate tax
rate of 12% on income that qualifies as “Preferred Technology Income,” as defined in the Investment Law. The tax rate is further
reduced to 7.5% for a Preferred Technology Enterprise located in development zone A. In addition, a Preferred Company qualified as having
a “Preferred Technological Enterprise” will enjoy a reduced corporate tax rate of 12% on capital gain derived from the
sale of certain “Benefitted Intangible Assets” (as defined in the Investment Law) to a related foreign company if the Benefitted
Intangible Assets were acquired from a foreign company on or after January 1, 2017 for at least NIS 200 million, and the sale receives
prior approval from the National Authority for Technological Innovation (previously known as the Israeli Office of the Chief Scientist),
to which we refer as IIA.
117
The 2017 Amendment further provides that a Preferred company
satisfying certain conditions (including group consolidated revenues of at least NIS 10 billion) may qualify as having a “Special
Preferred Technology Enterprise” and will thereby enjoy a reduced corporate tax rate of 6% on “Preferred Technology Income”
regardless of the company’s geographic location within Israel. In addition, a Special Preferred Technology Enterprise will enjoy
a reduced corporate tax rate of 6% on capital gain derived from the sale of certain “Benefitted Intangible Assets” to a related
foreign company if the Benefitted Intangible Assets were either developed by the Special Preferred Technology Enterprise or acquired from
a foreign company on or after January 1, 2017, and the sale received prior approval from IIA. A Special Preferred Technology Enterprise
that acquires Benefitted Intangible Assets from a foreign company for more than NIS 500 million will be eligible for these benefits for
at least ten years, subject to certain approvals as specified in the Investment Law.
Dividends distributed by a Preferred Technology Enterprise or
a Special Preferred Technology Enterprise, paid out of Preferred Technology Income, are generally subject to withholding tax at source
at the rate of 20% or such lower rate as may be provided in an applicable tax treaty (subject to the receipt in advance of a valid certificate
from the Israel Tax Authority allowing for a reduced tax rate). However, if such dividends are paid to an Israeli company, no tax is required
to be withheld. If such dividends are distributed to a foreign company and other conditions are met, the withholding tax rate will be
4%.
We currently are not entitled to tax benefits under the 2017
Amendment.
Taxation of Our Shareholders
Capital Gains
Capital gain tax is imposed on the disposition of capital assets
by an Israeli resident, and on the disposition of such assets by a non-Israeli resident if those assets are either (i) located in Israel;
(ii) are shares or a right to a share in an Israeli resident corporation, or (iii) represent, directly or indirectly, rights to assets
located in Israel. The Israeli Tax Ordinance distinguishes between “Real Gain” and the “Inflationary Surplus.”
Real Gain is the excess of the total capital gain over Inflationary Surplus computed generally on the basis of the increase in the Israeli
consumer price index between the date of purchase and the date of disposition. Inflationary Surplus is not currently subject to tax in
Israel.
Real Gain accrued by individuals on the sale of our ordinary shares
will be taxed at the rate of 25%. However, if the individual shareholder is a “Controlling Shareholder” (i.e., a person who
holds, directly or indirectly, alone or together with another, 10% or more of one of the Israeli resident company’s means of control)
at the time of sale or at any time during the preceding 12-month period, such gain will be taxed at the rate of 30%.
Real Gain derived by corporations will be generally subject to
the corporate tax rate of 23% in 2024.
Individual and corporate shareholder dealing in securities in Israel
are taxed at the tax rates applicable to business income —23% for corporations in 2024, and a marginal tax rate of up to 50% for
individuals, including an excess tax.
Notwithstanding the foregoing, capital gain derived from the sale
of our ordinary shares by a non-Israeli shareholder may be exempt under the Israeli Tax Ordinance from Israeli capital gain tax provided
that the seller does not have a permanent establishment in Israel to which the derived capital gain is attributed. However, non-Israeli
corporations will not be entitled to the foregoing exemption if more than 25% of its means of control are held, directly and indirectly,
by Israeli residents, and Israeli residents are entitled to 25% or more of the revenues or profits of the corporation, directly or indirectly.
In addition, such exemption would not be available to a person whose gains from selling or otherwise disposing of the securities are deemed
to be business income.
In addition, the sale of shares may be exempt from Israeli capital
gain tax under the provisions of an applicable tax treaty. For example, the U.S.-Israel Double Tax Treaty exempts U.S. residents from
Israeli capital gain tax in connection with such sale, provided (i) the U.S. resident owned, directly or indirectly, less than 10% of
an Israeli resident company’s voting power at any time within the 12-month period preceding such sale; (ii) the seller, being an
individual, is present in Israel for a period or periods of less than 183 days during the taxable year; and (iii) the capital gain from
the sale was not derived through a permanent establishment of the U.S. resident in Israel.
118
In some instances where our shareholders may be liable for Israeli
tax on the sale of their ordinary shares, the payment of the consideration may be subject to the withholding of Israeli tax at source
at a rate of 25% if the seller is an individual and at the corporate tax rate (23% in 2024) if the seller is a corporation. Shareholders
may be required to demonstrate that they are exempt from tax on their capital gains in order to avoid withholding at source at the time
of sale.
At the sale of securities traded on a stock exchange a detailed
return, including a computation of the tax due, must be filed and an advanced payment must be paid on January 31 and July 31 of every
tax year in respect of sales of securities made within the previous six months. However, if all tax due was withheld at source according
to applicable provisions of the Israeli Tax Ordinance and regulations promulgated thereunder, the aforementioned return need not be filed,
provided that (among other conditions) (i) such income was not generated from business conducted in Israel by the taxpayer, (ii) the taxpayer
has no other taxable sources of income in Israel with respect to which a tax return is required to be filed and an advance payment does
not need to be made, and (iii) the taxpayer is not obligated to pay Excess Tax (as further explained below). Capital gain is also reportable
on the annual income tax return.
Dividends
We have never paid cash dividends. A distribution of a dividend
by our company from income attributed to a Benefited Enterprise will generally be subject to withholding tax in Israel at a rate of 20%
unless a reduced tax rate is provided under an applicable tax treaty. A distribution of a dividend by our company from income attributed
to a Preferred Enterprise will generally be subject to withholding tax in Israel at the following tax rates: Israeli resident individuals
— 20%; Israeli resident companies — 0% for a Preferred Enterprise; Non-Israeli residents — 20%, subject to a reduced
rate under the provisions of any applicable double tax treaty. A distribution of dividends from income, which is not attributed to a Preferred
Enterprise to an Israeli resident individual, will generally be subject to withholding tax at a rate of 25%, or 30% if the dividend recipient
is a “Controlling Shareholder” (as defined above) at the time of distribution or at any time during the preceding 12-month
period. If the recipient of the dividend is an Israeli resident corporation, such dividend will not be subject to Israeli tax provided
the income from which such dividend is distributed was derived or accrued within Israel.
The Israeli Tax Ordinance provides that a non-Israeli resident
(either individual or corporation) is generally subject to Israeli withholding tax on the receipt of dividends at the rate of 25% (30%
if the dividends recipient is a “Controlling Shareholder” (as defined above), at the time of distribution or at any time during
the preceding 12-month period); those rates may be subject to a reduced rate under the provisions of an applicable double tax treaty.
Under the U.S.-Israel Double Tax Treaty, the following withholding rates will apply in respect of dividends distributed by an Israeli
resident company to a U.S. resident: (i) if the U.S. resident is a corporation which holds during that portion of the taxable year which
precedes the date of payment of the dividend and during the whole of its prior taxable year (if any), at least 10% of the outstanding
shares of the voting share capital of the Israeli resident paying corporation and not more than 25% of the gross income of the Israeli
resident paying corporation for such prior taxable year (if any) consists of certain type of interest or dividends — the rate is
12.5%, (ii) if both the conditions mentioned in clause (i) above are met and the dividend is paid from an Israeli resident company’s
income which was entitled to a reduced tax rate applicable to an Approved Enterprise — the rate is 15% and (iii) in all other
cases, the rate is 25%. The aforementioned rates under the Israel U.S. Double Tax Treaty will not apply if the dividend income was derived
through a permanent establishment of the U.S. resident in Israel.
A non-Israeli resident who receives dividends from which tax was
withheld is generally exempt from the obligation to file tax returns in Israel with respect to such income, provided that (among other
conditions) (i) such income was not generated from a business conducted in Israel by the taxpayer, (ii) the taxpayer has no other taxable
sources of income in Israel with respect to which a tax return is required to be filed, and (iii) the taxpayer is not obligated to pay
Excess Tax (as further explained below).
Dividends are generally subject to Israeli withholding tax at a
rate of 25% so long as the shares are registered with a nominee company (whether or not the recipient is a “Controlling Shareholder,”
as defined above), unless relief is provided in a treaty between Israel and the shareholder’s country of residence and provided
that a certificate from the Israel Tax Authority allowing for a reduced withholding tax rate is obtained in advance.
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Excess Tax
Individuals who are subject to tax in Israel are also subject to
an additional tax at a rate of 3% on annual income exceeding NIS 721,560 for 2024 linked to the annual change in the Israeli consumer
price index, including, but not limited to income derived from, dividends, interest and capital gains.
Foreign Exchange Regulations
Non-residents of Israel who hold our ordinary shares are able to
receive any dividends, and any amounts payable upon the dissolution, liquidation and winding up of our affairs, repayable in non-Israeli
currency at the rate of exchange prevailing at the time of conversion. However, Israeli income tax is generally required to have been
paid or withheld on these amounts. In addition, the statutory framework for the potential imposition of currency exchange control has
not been eliminated and may be restored at any time by administrative action.
Estate and Gift Tax
Israeli law presently does not impose estate or gift taxes.
U.S. Federal Income Tax Considerations
The following discussion describes certain material U.S. federal
income tax considerations to U.S. Holders (as defined below) under present law of an investment in our ordinary shares or warrants. This
discussion applies only to U.S. Holders that hold our ordinary shares or warrants as capital assets within the meaning of Section 1221
of the Internal Revenue Code of 1986, as amended, or the Code, and that have the U.S. dollar as their functional currency.
This discussion is based on the tax laws of the United States,
including the Code, as in effect on the date hereof and on U.S. Treasury regulations as in effect or, in some cases, as proposed, on the
date hereof, as well as judicial and administrative interpretations thereof available on or before such date. All of the foregoing authorities
are subject to change, which change could apply retroactively and could affect the tax consequences described below. This summary does
not address any estate or gift tax consequences, the alternative minimum tax, the Medicare tax on net investment income or any state,
local, or non-U.S. tax consequences. The following discussion neither deals with the tax consequences to any particular investor nor describes
all of the tax consequences applicable to persons in special tax situations such as:
| • |
banks |
| • |
certain financial institutions; |
| • |
insurance companies; |
| • |
regulated investment companies; |
| • |
real estate investment trusts; |
| • |
broker-dealers; |
| • |
traders in securities that elect to mark to market; |
120
| • |
U.S. expatriates; |
| • |
tax-exempt entities; |
| • |
persons holding our ordinary shares or warrants as part of a straddle, hedging, constructive sale, conversion or integrated transaction;
|
| • |
persons that actually or constructively (including through the ownership of our warrants) own 10% or more of our share capital (by
vote or value); |
| • |
persons that are resident or ordinarily resident in or have a permanent establishment in a jurisdiction outside the United States;
|
| • |
persons who acquired our ordinary shares or warrants pursuant to the exercise of any employee share option or otherwise as compensation;
|
| • |
persons subject to special tax accounting rules as a result of any item of gross income with respect to our ordinary shares or warrants
being taken into account in an applicable financial statement; or |
| • |
pass-through entities, or persons holding our ordinary shares or warrants through pass-through entities. |
INVESTORS ARE URGED TO CONSULT THEIR TAX ADVISORS ABOUT THE APPLICATION
OF THE U.S. FEDERAL TAX RULES TO THEIR PARTICULAR CIRCUMSTANCES AS WELL AS THE STATE, LOCAL, NON-U.S. AND OTHER TAX CONSEQUENCES TO THEM
OF AN INVESTMENT IN OUR ORDINARY SHARES OR WARRANTS.
The discussion below of the U.S. federal
income tax consequences to “U.S. Holders” will apply to you if you are the beneficial owner of our ordinary shares or warrants
and you are, for U.S. federal income tax purposes,
| • |
an individual who is a citizen or resident of the United States; |
| • |
a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized in the United
States or under the laws of the United States, any state thereof or the District of Columbia; |
| • |
an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or |
| • |
a trust that (i) is subject to the primary supervision of a court within the United States and the control of one or more U.S. persons
for all substantial decisions or (ii) has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a U.S.
person. |
If an entity or other arrangement treated as a partnership for
U.S. federal income tax purposes holds our ordinary shares or warrants, the tax treatment of a partner will generally depend upon the
status of the partner and the activities of the partnership. A person that would be a U.S. Holder if it held our ordinary shares or warrants
directly and that is a partner of a partnership holding our ordinary shares or warrants is urged to consult its own tax advisor.
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Passive Foreign Investment Company
We believe that we were a passive foreign investment company,
or PFIC, for our 2024 taxable year. A non-U.S. entity treated as a corporation for U.S. federal income tax purposes will generally be
a PFIC for U.S. federal income tax purposes for any taxable year if either:
| • |
at least 75% of its gross income for such year is passive income; or |
| • |
at least 50% of the value of its assets (based on an average of the quarterly values of the assets) during such year is attributable
to cash or other assets that produce passive income or are held for the production of passive income. |
For this purpose, we will be treated as owning our proportionate
share of the assets and earning our proportionate share of the income of any other entity treated as a corporation for U.S. federal income
tax purposes in which we own, directly or indirectly, 25% or more (by value) of the stock. Subject to various exceptions, passive income
generally includes dividends, interest, capital gains, royalties and rents (other than royalties and rents derived in the active conduct
of a trade or business and not derived from a related person).
Because the value of our assets for purposes of the PFIC asset
test will generally be determined by reference to the market price of our ordinary shares, based on the value and composition of our assets
for our 2024 taxable year (including, in particular, the size of our cash and other passive assets) and the changes in the market price
of our ordinary shares during our 2024 taxable year, we expect that we will be treated as a PFIC for U.S. federal income tax purposes
for our 2024 taxable year. Additionally, we may be a PFIC in the current taxable year or in any subsequent taxable year. The determination
of whether we are a PFIC is a fact-intensive determination made on an annual basis and the applicable law is subject to varying interpretation.
A separate determination must be made after the close of each
taxable year as to whether we were a PFIC for that year. Depending on the market price of our ordinary shares and the composition of our
assets, our status as a PFIC may change in subsequent years. However, if we are or were a PFIC for any taxable year during your holding
period for our ordinary shares (or under proposed U.S. Treasury Regulations, our warrants), we generally will continue to be treated as
a PFIC with respect to your investment in our ordinary shares or warrants for all succeeding years during which you hold our ordinary
shares or warrants, and, although subject to uncertainty, potentially our ordinary shares received upon exercise of such warrants. You
are advised to consult your own tax advisor regarding the potential availability of a “deemed sale” election that would allow
you to eliminate this continuing PFIC status under certain circumstances.
For each taxable year that we are treated as a PFIC with respect
to you, you will be subject to adverse consequences under special tax rules with respect to any “excess distribution” (as
defined below) you receive and any gain you realize from a sale or other disposition (including a pledge) of our ordinary shares or warrants,
unless you make a valid “mark-to-market” election or “qualified electing fund” election, each as discussed below,
and each of which may not be available for the warrants. Distributions you receive in a taxable year that are greater than 125% of the
average annual distributions you received during the shorter of the three preceding taxable years or your holding period will be treated
as an “excess distribution.” Under these special tax rules:
| • |
the excess distribution or gain will be allocated ratably over your holding period; |
| • |
the amount allocated to the current taxable year, and any taxable years in your holding period prior to the first taxable year in
which we were a PFIC, will be treated as ordinary income; and |
| • |
the amount allocated to each other taxable year will be subject to the highest tax rate in effect for individuals or corporations,
as applicable, for each such year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting
tax attributable to each such year. |
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The tax liability for amounts allocated to taxable years prior
to the year of disposition or excess distribution cannot be offset by any net operating losses, and gains (but not losses) realized on
the sale of our ordinary shares or warrants cannot be treated as capital gains, even if you hold our ordinary shares or warrants as capital
assets.
If we are or were treated as a PFIC with respect to you for any
taxable year, to the extent any of our subsidiaries are also PFICs (of which there are none at present), you may be deemed to own a proportionate
interest in such lower-tier PFICs that are directly or indirectly owned by us, and you may be subject to the adverse tax consequences
described above with respect to the shares of such lower-tier PFICs you would be deemed to own. As a result, you may incur liability for
any excess distribution described above if we receive a distribution from our lower-tier PFICs (of which there are none at present) or
if any shares in such lower-tier PFICs are disposed of (or deemed disposed of). You should consult your tax advisor regarding the application
of the PFIC rules to any of our subsidiaries in the event that our group includes one or more lower-tier PFICs.
A U.S. Holder of “marketable stock” (as defined below)
in a PFIC may make a mark-to-market election for such stock to elect out of the tax treatment discussed above. If you make a valid mark-to-market
election for our ordinary shares, you will include in income for each year that we are treated as a PFIC with respect to you an amount
equal to the excess, if any, of the fair market value of our ordinary shares as of the close of your taxable year over your adjusted basis
in such ordinary shares. You will be allowed a deduction for the excess, if any, of the adjusted basis of our ordinary shares over their
fair market value as of the close of the taxable year. However, deductions will be allowable only to the extent of any net mark-to-market
gains on our ordinary shares included in your income for prior taxable years. Amounts included in your income under a mark-to-market election,
as well as gain on the actual sale or other disposition of our ordinary shares, will be treated as ordinary income. Ordinary loss treatment
will also apply to the deductible portion of any mark-to-market loss on our ordinary shares, as well as to any loss realized on the actual
sale or disposition of our ordinary shares, to the extent the amount of such loss does not exceed the net mark-to-market gains for such
ordinary shares previously included in income. Your basis in our ordinary shares will be adjusted to reflect any such income or loss amounts.
If you make a mark-to-market election, any distributions we make would generally be subject to the rules discussed below under “—
Taxation of Dividends and Other Distributions on our ordinary shares,” except the lower rates applicable to qualified dividend income
would not apply.
The mark-to-market election is available only for “marketable
stock,” which is stock that is regularly traded on a qualified exchange or other market, as defined in applicable U.S. Treasury
Regulations, and may not include our warrants. Our ordinary shares are listed on the Nasdaq Capital Market. The Nasdaq Capital Market
is a qualified exchange, but there can be no assurance that the trading in our ordinary shares will be sufficiently regular to qualify
our ordinary shares as marketable stock. Because a mark-to-market election cannot be made for equity interests in any lower-tier PFICs
we own (of which there are none at present), you generally will continue to be subject to the PFIC rules with respect to your indirect
interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes. You should
consult your tax advisor as to the availability and desirability of a mark-to-market election, as well as the impact of such election
on interests in any lower-tier PFICs (of which there are none at present).
Alternatively, if a non-U.S. entity treated as a corporation
is a PFIC, a holder of shares in that entity may avoid taxation under the PFIC rules described above regarding excess distributions and
recognized gains by making a “qualified electing fund” election, or QEF election, to include in income its share of the entity’s
income on a current basis. A U.S. Holder of our ordinary shares can make a QEF election, if we provide the certain necessary information
with respect to our annual ordinary earnings and net capital gain, in the first taxable year that we are treated as a PFIC with respect
to the U.S. Holder. A U.S. Holder must make the QEF election for each PFIC by attaching a separate properly completed IRS Form 8621 for
each PFIC to its timely filed U.S. federal income tax return. We plan to provide upon request or otherwise make available the information
necessary for a U.S. Holder to make a QEF election with respect to us and will use commercially reasonable efforts to cause each lower-tier
PFIC which we control, of which there are none at present, to provide such information with respect to such lower-tier PFIC. However,
no assurance can be given that such information will be available for any lower-tier PFIC.
If you make a QEF election with respect to a PFIC, you will be
currently taxable on its pro rata share of the PFIC’s ordinary earnings and net capital gain (at ordinary income and capital gain
rates, respectively) for each taxable year that the entity is classified as a PFIC. If you make a QEF election with respect to us, any
distributions paid by us out of our earnings and profits that were previously included in your income as a result of the QEF election
will not be taxable to you. You will increase your tax basis in our ordinary shares by an amount equal to any income you have included
as a result of the QEF election and will decrease your tax basis in our ordinary shares by any amount distributed on the ordinary shares
that you have not included in your income. In addition, you will recognize capital gain or loss on the disposition of our ordinary shares
in an amount equal to the difference between the amount realized and your adjusted tax basis in our ordinary shares. You should note that
if you make QEF elections with respect to us and any lower-tier PFICs, you may be required to pay U.S. federal income tax with respect
to our ordinary shares for any taxable year significantly in excess of any cash distributions received on your ordinary shares for such
taxable year.
A QEF election may not be available for our warrants regardless
of whether we provide the information described above. You are strongly advised to consult your own tax advisors regarding making QEF
elections in your particular circumstances.
A U.S. Holder of a PFIC may be required to file an IRS Form 8621.
If we are a PFIC, you should consult your tax advisor regarding any reporting requirements that may apply to you. You are urged to consult
your tax advisor regarding the application of the PFIC rules to an investment in ordinary shares or warrants.
YOU ARE STRONGLY
URGED TO CONSULT YOUR TAX ADVISOR REGARDING THE IMPACT ON YOUR INVESTMENT IN OUR ORDINARY SHARES OR WARRANTS IF WE WERE TO BE CONSIDERED
A PFIC AS WELL AS THE APPLICATION OF THE PFIC RULES AND THE POSSIBILITY OF MAKING A MARK-TO-MARKET ELECTION OR QUALIFIED ELECTING FUND
ELECTION.
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Taxation of Dividends and Other Distributions on our Ordinary Shares
Subject to the PFIC rules discussed above, the gross amount of
any distributions we make to you (including the amount of any tax withheld) with respect to our ordinary shares generally will be includible
in your gross income as dividend income on the date of receipt by the holder, but only to the extent the distribution is paid out of our
current or accumulated earnings and profits (as determined under U.S. federal income tax principles). The dividends will not be eligible
for the dividends-received deduction allowed to corporations in respect of dividends received from other U.S. corporations. To the extent
the amount of the distribution exceeds our current and accumulated earnings and profits (as determined under U.S. federal income tax principles),
such excess amount will be treated first as a tax-free return of your tax basis in your ordinary shares, and then, to the extent such
excess amount exceeds your tax basis in your ordinary shares, as capital gain. We currently do not, and we do not intend to, calculate
our earnings and profits under U.S. federal income tax principles. Therefore, you should expect that a distribution will generally be
reported as a dividend even if that distribution would otherwise be treated as a non-taxable return of capital or as capital gain under
the rules described above.
With respect to certain non-corporate U.S. Holders, including
individual U.S. Holders, dividends may be taxed at the lower capital gain rates applicable to “qualified dividend income,”
provided (i) our ordinary shares are readily tradable on an established securities market in the United States (such as the Nasdaq Capital
Market), (ii) we are neither a PFIC nor treated as such with respect to you (as discussed above) for either the taxable year in which
the dividend was paid or the preceding taxable year, (iii) certain holding period requirements are met, and (iv) you are not under an
obligation to make related payments with respect to positions in substantially similar or related property.
The amount of any distribution paid in a currency other than
U.S. dollars will be equal to the U.S. dollar value of such currency on the date such distribution is includible in your income, regardless
of whether the payment is in fact converted into U.S. dollars at that time. The amount of any distribution of property other than cash
will be the fair market value of such property on the date of distribution.
Any dividends will constitute foreign source income for foreign
tax credit limitation purposes. If the dividends are taxed as qualified dividend income (as discussed above), the amount of the dividend
taken into account for purposes of calculating the foreign tax credit limitation will in general be limited to the gross amount of the
dividend, multiplied by the reduced tax rate applicable to qualified dividend income and divided by the highest tax rate normally applicable
to dividends. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income.
For this purpose, dividends distributed by us with respect to our ordinary shares will generally constitute “passive category income.”
If Israeli withholding taxes apply to any dividends paid to you
with respect to our ordinary shares, subject to certain conditions and limitations, such withholding taxes may be treated as foreign taxes
eligible for credit against your U.S. federal income tax liability. Instead of claiming a credit, you may elect to deduct such taxes in
computing taxable income, subject to applicable limitations. If a refund of the tax withheld is available under the applicable laws of
Israel or under the Israel-U.S. income tax treaty, or the Treaty, the amount of tax withheld that is refundable will not be eligible for
such credit against your U.S. federal income tax liability (and will not be eligible for the deduction against your U.S. federal taxable
income). The rules relating to the determination of the foreign tax credit are complex, and you should consult your tax advisor regarding
the availability of a foreign tax credit in your particular circumstances, including the effects of the Treaty.
Constructive Dividends on our
Ordinary Shares or Warrants
If the exercise price of our warrants is adjusted in certain
circumstances (or in certain circumstances, there is a failure to make adjustments or a failure to make adequate adjustments), that adjustment
(or failure to adjust) may result in the deemed payment of a taxable dividend to a U.S. Holder of the warrants or our ordinary shares.
Any such constructive dividend will be taxable generally as described above under “Taxation of Dividends and Other Distributions
on our ordinary shares.” Generally, a U.S. Holder’s tax basis in our ordinary shares or the warrants will be increased to
the extent of any such constructive dividend. It is not entirely clear whether a constructive dividend deemed paid to a non-corporate
U.S. Holder could be “qualified dividend income” as discussed above under “Taxation of Dividends and Other Distributions
on our ordinary shares.” U.S. Holders should consult their tax advisers regarding the proper U.S. federal income tax treatment of
any adjustments to (or failure to adjust or adjust adequately) the exercise price of the warrants.
We are currently required to report the amount of any constructive
dividends on our website or to the IRS and to holders not exempt from reporting. The IRS has proposed U.S. Treasury Regulations addressing
the amount and timing of constructive dividends, as well as, obligations of withholding agents and filing and notice obligations of issuers
in respect of such constructive dividends. If adopted as proposed, the U.S. Treasury Regulations would generally provide that (i) the
amount of a constructive dividend is the excess of the fair market value of the right to acquire stock immediately after the exercise
price adjustment over the fair market value of the right to acquire stock (after the exercise price adjustment) without the adjustment,
(ii) the constructive dividend occurs at the earlier of the date the adjustment occurs under the terms of the instrument and the date
of the actual distribution of cash or property that results in the constructive dividend, and (iii) we are required to report the amount
of any constructive dividends on our website or to the IRS and to all holders (including holders that would otherwise be exempt from reporting).
The final U.S. Treasury Regulations will be effective for constructive dividends occurring on or after the date of adoption, but holders
and withholding agents may rely on them prior to that date under certain circumstances.
124
Taxation of Disposition of our
Ordinary Shares or Warrants
Subject to the PFIC rules discussed above, upon a sale or other
disposition of our ordinary shares or warrants, you will generally recognize capital gain or loss for U.S. federal income tax purposes
in an amount equal to the difference between the amount realized (including the amount of any tax withheld) and your tax basis in such
ordinary shares or warrants. If the consideration you receive for our ordinary shares or warrants is not paid in U.S. dollars, the amount
realized will be the U.S. dollar value of the payment received determined by reference to the spot rate of exchange on the date of the
sale or other disposition. However, if our ordinary shares or warrants are treated as traded on an “established securities market”
and you are either a cash basis taxpayer or an accrual basis taxpayer that has made a special election (which must be applied consistently
from year to year and cannot be changed without the consent of the IRS), you will determine the U.S. dollar value of the amount realized
in a non-U.S. dollar currency by translating the amount received at the spot rate of exchange on the settlement date of the sale. If you
are an accrual basis taxpayer that is not eligible to or does not elect to determine the amount realized using the spot rate on the settlement
date, you will recognize foreign currency gain or loss to the extent of any difference between the U.S. dollar amount realized on the
date of sale or disposition and the U.S. dollar value of the currency received at the spot rate on the settlement date.
Any gain or loss on the sale or other disposition of our ordinary
shares or warrants will generally be treated as U.S. source income or loss and treated as long-term capital gain or loss if your holding
period in our ordinary shares or warrants at the time of the disposition exceeds one year. Accordingly, in the event any Israeli tax (including
withholding tax) is imposed upon the sale or other disposition, you may not be able to utilize foreign tax credit unless you have foreign
source income or gain in the same category from other sources. There are additional significant and complex limits on a U.S. Holder’s
ability to claim foreign tax credits, and U.S. Treasury Regulations published in 2022 that apply to foreign income taxes further restrict
the availability of any such credit based on the nature of the tax imposed by the foreign jurisdiction. Although the U.S. Department of
the Treasury and the IRS provided relief in 2023 from certain provisions of these U.S, Treasury Regulations for the indefinite future,
their potential impact remains uncertain and could be adverse. Long-term capital gain of non-corporate U.S. Holders generally will be
subject to U.S. federal income tax at reduced tax rates. The deductibility of capital losses is subject to significant limitations. The
rules governing foreign tax credits are complex and, therefore, U.S. Holders are urged to consult their own tax advisors to determine
whether they are subject to any special rules that limit their ability to make effective use of foreign tax credits.
Taxation of Exercise or Expiration
of our Warrants
In general, you will not be required to recognize income, gain
or loss upon exercise of our warrants by payment of the exercise price. Your tax basis in our ordinary shares received upon exercise of
our warrants will be equal to the sum of (1) your tax basis in the warrants exchanged therefor, and (2) the exercise price of the warrants.
Your holding period in our ordinary shares received upon exercise will commence on the day after you exercise the warrants.
Although there is no direct legal authority as to the U.S. federal
income tax treatment of an exercise of our warrants on a cashless basis, if required to do so, we intend to take the position that such
exercise will not be taxable, either because the exercise is not a gain realization event or because it qualifies as a tax-free recapitalization.
In the former case, the holding period of our ordinary shares received upon exercise of the warrants should commence on the day after
the ordinary warrants are exercised. In the latter case, the holding period of our ordinary shares received upon exercise of the ordinary
warrants would include the holding period of the exercised ordinary warrants. However, such position is not binding on the IRS, and the
IRS may treat a cashless exercise of the ordinary warrants as, in part, a taxable exchange. U.S. Holders are urged to consult their tax
advisors as to the consequences of an exercise of the ordinary warrants on a cashless basis, including with respect to potential treatment
as a taxable disposition of warrants for PFIC purposes, and the holding period and tax basis in our ordinary shares received.
If the warrants expire without being exercised, you will recognize
a capital loss in an amount equal to your tax basis in the warrants. Such loss will be long-term capital loss if, at the time of the expiration,
your holding period in the warrants is more than one year. The deductibility of capital losses is subject to limitations.
Information Reporting and Backup
Withholding
Dividend payments (including constructive dividends) with respect
to our ordinary shares or warrants and proceeds from the sale, exchange or redemption of our ordinary shares or warrants may be subject
to information reporting to the IRS and possible U.S. backup withholding. Backup withholding will not apply, however, to a U.S. Holder
that furnishes a correct taxpayer identification number and makes any other required certification or that is otherwise exempt from backup
withholding. U.S. Holders that are required to establish their exempt status generally must provide such certification on IRS Form W-9.
You should consult your tax advisor regarding the application of the U.S. information reporting and backup withholding rules.
Backup withholding is not an additional tax. Amounts withheld
as backup withholding may be credited against your U.S. federal income tax liability, and you may obtain a refund of any excess amounts
withheld under the backup withholding rules by filing the appropriate claim for refund with the IRS and furnishing any required information
in a timely manner.
125
Information with respect to Foreign
Financial Assets
Certain U.S. Holders may be required to report information relating
to an interest in our ordinary shares or warrants, subject to certain exceptions (including an exception for ordinary shares held in accounts
maintained by certain financial institutions). Penalties can apply if U.S. Holders fail to satisfy such reporting requirements. You should
consult your tax advisor regarding the effect, if any, of this requirement on your ownership and disposition of our ordinary shares.
THE SUMMARY OF U.S. FEDERAL INCOME TAX CONSIDERATIONS SET OUT
ABOVE IS FOR GENERAL INFORMATIONAL PURPOSES ONLY. INVESTORS ARE URGED TO CONSULT THEIR TAX ADVISORS ABOUT THE APPLICATION OF THE U.S.
FEDERAL TAX RULES TO THEIR PARTICULAR CIRCUMSTANCES AS WELL AS THE STATE, LOCAL, NON-U.S. AND OTHER TAX CONSEQUENCES TO THEM OF AN INVESTMENT
IN OUR ORDINARY SHARES OR WARRANTS.
F.
Dividends and Paying Agents
Not applicable.
G.
Statement by Experts
Not applicable.
H.
Documents on Display
We are subject to the information reporting requirements of the
Exchange Act, applicable to foreign private issuers, and under those requirements, we file reports with the SEC. Our filings with the
SEC are available to the public through the SEC’s website at http://www.sec.gov.
As a foreign private issuer, we are exempt from the rules under
the Exchange Act, related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders are
exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we are
not required under the Exchange Act, to file annual, quarterly and current reports and financial statements with the SEC as frequently
or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we are required to comply with the informational
requirements of the Exchange Act, and, accordingly, file current reports on Form 6-K, annual reports on Form 20-F and other information
with the SEC.
I.
Subsidiary Information
Not applicable.
ITEM 11.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risks in the ordinary course of our business.
Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates.
Our market risk exposure is primarily a result of foreign currency exchange rates, which is discussed in detail below.
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Interest Rate Risk
We do not anticipate undertaking any significant long-term borrowings.
At present, our investments consist primarily of marketable securities
and bank deposits. We may be exposed to market price risk because of investments in tradable securities, mainly corporate bonds, held
by us and classified in our financial statements as financial assets at fair value through profit or loss. To manage the price risk arising
from investments in tradable securities, we invest in marketable securities with high ratings and diversify our investment portfolio.
Our investments may also be exposed to market risk due to fluctuation in interest rates, which may affect our interest income and the
fair market value of our investments, if any.
Foreign Currency Exchange Risk
The U.S. dollar is our functional and reporting currency. Although
a substantial portion of our expenses (mainly salaries and related costs) are denominated in NIS, accounting for more than half of our
expenses in the year ended December 31, 2024, all of our financing has been in U.S. dollars and the vast majority of our liquid assets
are held in U.S. dollars. Furthermore, while we anticipate that a portion of our expenses, principally salaries and related personnel
expenses in Israel, will continue to be denominated in NIS, we expect to incur an increasing amount of expenses in U.S. dollars as we
progress in the development and the regulatory processes of our product candidates. Changes of 5% in the U.S. dollar/NIS exchange rate
would have increased/decreased operating expenses by approximately 2.02% during the fiscal year ended on December 31, 2024. We also
have expenses, although to a much lesser extent, in other non-U.S. dollar currencies, in particular the Euro.
Moreover,
for the next few years we expect that the substantial majority of our revenues from the sale of our products in the United States, if
any, will be denominated in U.S. dollars. Since a portion of our expenses is denominated in NIS and other non-U.S. currencies, we are
exposed to risk associated with exchange rate fluctuations vis-à-vis the non-U.S. currencies. See “Item 3 – D. Risk Factors —
Exchange rate fluctuations between the U.S. dollar, the New Israeli Shekel and other foreign currencies, may negatively affect our future
revenues.” If the NIS fluctuates significantly against the U.S. dollar it may have a negative impact on our results of operations.
As of the date of this annual report and for the periods under review, fluctuations in the currencies exchange rates have not materially
affected our results of operations or financial condition.
The Company carries out transactions involving foreign currency
exchange derivative financial instruments. The transactions are designed to hedge the Company’s exposure in currencies other than
the U.S. dollar. The derivative does not meet the definition of a cash flow accounting hedge, and therefore the changes in the fair value
are included in financial expense (income), net.
Inflation-related risks
We do not believe that the rate of inflation in Israel has had
a material impact on our business to date; however, our costs in Israel will increase if the inflation rate in Israel exceeds the devaluation
of the NIS against the U.S. dollar or if the timing of such devaluation lags behind inflation in Israel.
ITEM 12.
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt
Securities
Not applicable.
B.
Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American
Depositary Shares
Not applicable.
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES
AND DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL
MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
127
ITEM 15.
CONTROLS AND PROCEDURES
(a) Disclosure
Controls and Procedures
We performed an evaluation of the effectiveness of our disclosure
controls and procedures that are designed to ensure that information required to be disclosed and filed with the SEC is recorded, processed,
summarized and reported timely within the time period specified in the SEC’s rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports
that we file or submit under the Exchange Act, is accumulated and communicated to our management, including our principal executive and
principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
There can be no assurance that our disclosure controls and procedures will detect or uncover all failures of persons within the company
to disclose information otherwise required to be set forth in our reports. Nevertheless, our disclosure controls and procedures are designed
to provide reasonable assurance of achieving the desired control objectives. Based on our evaluation, our management, including our Chief
Executive Officer and Chief Financial Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e) of the Exchange Act) as of the end of the period covered by this report are effective at such reasonable assurance level.
(b) Management’s
Annual Report on Internal Control over Financial Reporting
Our management, under the supervision of our Chief Executive Officer
and Chief Financial Officer, is responsible for establishing and maintaining adequate internal control over our financial reporting, as
defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act of 1934, as amended. The Company’s internal control over financial
reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial
reporting includes policies and procedures that:
| • |
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;
|
| • |
provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in
accordance with generally accepted accounting principles; |
| • |
provide reasonable assurance that receipts and expenditures are made only in accordance with authorizations of our management and
board of directors (as appropriate); and |
| • |
provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets
that could have a material effect on our financial statements. |
Due to its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject
to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or
procedures may deteriorate.
Under the supervision and with the participation of our management,
including our Chief Executive Officer and Chief Financial Officer, we assessed the effectiveness of our internal control over financial
reporting as of December 31, 2024 based on the framework for Internal Control-Integrated Framework set forth by The Committee of Sponsoring
Organizations of the Treadway Commission (COSO) (2013).
Based on our assessment and this framework, our management
concluded that the Company’s internal control over financial reporting was effective as of December 31, 2024.
(c) Attestation
Report of Registered Public Accounting Firm
Not applicable.
(d)
Changes in Internal Controls Over Financial Reporting
There were no changes in our internal control over financial
reporting that occurred during the year ended December 31, 2024 that have materially affected or are reasonably likely to materially affect
our internal control over financial reporting.
128
ITEM 16.
[RESERVED]
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
Our board of directors has determined that each of Mr. Ran Gottfried
and Mr. Yuval Yanai is an audit committee financial expert. Mr. Ran Gottfried and Mr. Yuval Yanai are independent directors for the purposes
of the Nasdaq Listing Rules.
ITEM 16B. CODE OF ETHICS
We have adopted a code of ethics that applies to our principal
executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. This
code of ethics is posted on our website, http://ir.sol-gel.com/corporate-governance/governance-overview.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Fees Paid to Independent Registered Public Accounting
Firm
The following table sets forth, for each of the years indicated,
the aggregate fees billed by our independent registered public accounting firm for professional services.
|
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Year Ended December 31, |
| |||||
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Services Rendered |
|
2024 |
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2023 |
| ||
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(U.S. dollars in thousands) |
| |||||
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Audit Fees (1) |
|
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187 |
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220 |
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Tax (2) |
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62 |
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7 |
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Other (3) |
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2 |
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2 |
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Total |
|
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251 |
|
|
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229 |
|
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(1) |
Audit Fees consist of professional services rendered in connection with the audit
of our consolidated financial statements, review of our consolidated quarterly financial statements, issuance of comfort letters, consents
and assistance with review of documents filed with the SEC.
|
|
(2) |
Tax fees relate to tax compliance, planning and advice.
|
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(3) |
Other fees relate to license fees for use of accounting research tools. |
Audit Committee Pre-Approval Policies and Procedures
Our audit committee’s specific responsibilities in carrying
out its oversight of the quality and integrity of the accounting, auditing and reporting practices of the Company include the approval
of audit and non-audit services to be provided by the external auditor. The audit committee approves in advance the particular services
or categories of services to be provided to the Company during the following yearly period and also sets forth a specific budget for such
audit and non-audit services. Additional non-audit services may be pre-approved by the audit committee.
129
ITEM 16D. EXEMPTIONS
FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY
THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING
ACCOUNTANT
Not applicable.
ITEM 16G. CORPORATE GOVERNANCE
Nasdaq Stock Listing Rules
and Home Country Practices
As a foreign private issuer, we are exempt from the rules under
the Exchange Act related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will
be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. Also, we are not
required to comply with Regulation FD, which restricts the selective disclosure of material information. However, we intend to file with
the SEC, within 120 days after the end of each fiscal year, or such applicable time as required by the SEC, an annual report on Form 20-F
containing financial statements audited by an independent registered public accounting firm, and we intend to submit to the SEC from time
to time, on Form 6-K, reports of information that would likely be material to an investment decision in our securities.
As a foreign private issuer, we are permitted to follow certain
Israeli corporate governance practices instead of the Nasdaq corporate governance rules, provided that we disclose which requirements
we are not following and the equivalent Israeli requirement. Pursuant to the “foreign private issuer exemption”:
| • |
the quorum for any meeting of shareholders is two or more shareholders holding at least 33-1∕3% of our voting rights, which
complies with Nasdaq requirements; however, if the meeting is adjourned for lack of quorum, the quorum for such adjourned meeting will
be any number of shareholders, instead of 33-1∕3% of our voting rights; |
| • |
we adopt and approve material changes to equity incentive plans in accordance with the Companies Law, which does not impose a requirement
of shareholder approval for such actions. In addition, we intend to follow Israeli corporate governance practice in lieu of Nasdaq Marketplace
Rule 5635(c), which requires shareholder approval prior to an issuance of securities in connection with equity based compensation of officers,
directors, employees or consultants; |
| • |
as opposed to making periodic reports to shareholders and proxy solicitation materials available to shareholders in the manner specified
by the Nasdaq corporate governance rules, the Companies Law does not require us to distribute periodic reports directly to shareholders,
and the generally accepted business practice in Israel is not to distribute such reports to shareholders but to make such reports available
through a public website. We only mail such reports to shareholders upon request; and |
| • |
we follow Israeli corporate governance practice instead of Nasdaq requirements to obtain shareholder approval for certain dilutive
events (such as issuances that will result in a change of control, certain transactions other than a public offering involving issuances
of a 20% or greater interest in us and certain acquisitions of the stock or assets of another company). |
Otherwise, we intend to comply with the rules generally applicable
to U.S. domestic companies listed on the Nasdaq Capital Market. We may in the future decide to use the foreign private issuer exemption
with respect to some or all of the other Nasdaq corporate governance rules. We also intend to comply with Israeli corporate governance
requirements under the Companies Law applicable to public companies.
130
Controlled Company
As of the date of this annual report, Arkin Dermatology controls
over 50% of the combined voting power of our equity interests through the ownership of Ordinary Shares and as a result, we are a “controlled
company” within the meaning of the Nasdaq listing rules. A “controlled company” is a company of which more than 50%
of the voting power is held by an individual, group or another company. Pursuant to the “controlled company” exemption, we
are not required to, and do not expect to, comply with, the requirement that a majority of our board of directors consist of independent
directors, and we are not required to, and do not comply with, the requirement that we have a nominating committee composed entirely
of independent directors with a written charter addressing such committee’s purpose and responsibilities. See “Item 6. Directors,
Senior Management and Employees — C. Board Practices."
ITEM 16H. MINE SAFETY
DISCLOSURE
Not applicable.
ITEM 16I. DISCLOSURE REGARDING
FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 16J. INSIDER TRADING POLICIES
ITEM 16K. CYBERSECURITY
Cybersecurity Risk Management and Strategy
We design and assess our program based on the best common practice for our industry, ISO 27001 standards and SOX requirements. This does not imply that we meet any particular technical standards, specifications, or requirements, only that we use the ISO 27001 and SOX requirements as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.
Our cybersecurity risk management program is integrated into our overall enterprise risk management program, and shares common methodologies, reporting channels and governance processes that apply across the enterprise risk management program to other legal, compliance, strategic, operational, and financial risk areas.
131
Our cybersecurity risk management program includes:
| • |
risk assessments designed to help identify material cybersecurity risks to our critical systems, information, products, services, and our broader enterprise information technology environment;
|
| • |
a team principally responsible for managing (1) our cybersecurity risk assessment processes, (2) our security controls, and (3) our response to cybersecurity incidents;
|
| • |
the use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security controls;
|
| • |
cybersecurity awareness training of our employees, incident response personnel, and senior management;
|
| • |
a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents; and
|
| • |
|
Cybersecurity Governance
Our Board considers cybersecurity risk as part of its risk oversight function. The Board oversees implementation of our cybersecurity risk management program by management and our external information technology service provider.
The Board receives periodic reports from management on our cybersecurity risks. In addition, management updates the Board, as necessary, regarding any material cybersecurity incidents, as well as any incidents with lesser impact potential.
ITEM 17. FINANCIAL STATEMENTS
Not applicable.
ITEM 18. FINANCIAL STATEMENTS
The financial statements required by this item are found at the end of this annual report, beginning on page F-1.
132
ITEM 19. EXHIBITS
The exhibits filed with or incorporated into this annual report are listed in the index of exhibits below.
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Exhibit Number
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Exhibit Description
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133
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134
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101
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The following financial statements from the Company’s 20-F for the fiscal year ended December 31, 2024, formatted in XBRL: (i) Consolidated Statements of Comprehensive Loss, (ii) Consolidated Statements of Financial Position, (iii) Consolidated Statements of Changes in Equity, (iv) Consolidated Statements of Cash Flows, and (v) Notes to the Consolidated Financial Statements.
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*
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Filed herewith.
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†
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Certain confidential portions of this exhibit have been redacted from the publicly filed document because such portions are (i) not material and (ii) would be competitively harmful if publicly disclosed.
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^
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Certain schedules and/or exhibits to this Exhibit have been omitted in accordance with the instructions to Item 19 of Form 20-F. A copy of any omitted schedule and/or exhibit will be furnished supplementally to the Securities and Exchange Commission or its staff upon request.
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∞
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Informal translation of the original Hebrew document.
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The exhibits filed with or incorporated into this Registration Statement are listed in the index of exhibits below.
135
SIGNATURE
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
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SOL-GEL TECHNOLOGIES LTD.
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By:
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/s/ Moshe Arkin
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Name:
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Moshe Arkin
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Title:
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Chief Executive Officer
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By:
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/s/ Eyal Ben-Or
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Name:
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Eyal Ben-Or
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Title:
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Chief Financial Officer
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Date: April 29, 2025
136
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2024
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED FINANCIAL STATEMENTS
AS OF DECEMBER 31, 2024
TABLE OF CONTENTS
|
Page
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name: Kesselman & Kesselman C.P.A.s PCAOB ID:
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F-2
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CONSOLIDATED FINANCIAL STATEMENTS:
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F-3
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F-4
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F-5
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F-6
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F-7
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Report of Independent Registered Public Accounting Firm
To the board of directors and shareholders of Sol-Gel Technologies Ltd.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Sol-Gel Technologies Ltd. and its subsidiary (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, of changes in shareholders' equity and of cash flows for each of the three years in the period ended December 31, 2024, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024 in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. We determined there are no critical audit matters.
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/s/
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April 29, 2025
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Certified Public Accountants (Isr.)
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A member firm of PricewaterhouseCoopers International Limited
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We have served as the Company's auditor since 2000.
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Kesselman & Kesselman, 146 Derech Menachem Begin, Tel-Aviv 6492103, Israel,
P.O Box 50005 Tel-Aviv 6150001, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
F-2
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
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December 31
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||||||||
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2023
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2024
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Assets
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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$
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Bank deposits
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Marketable securities
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Accounts receivables
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Prepaid expenses and other current assets
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TOTAL CURRENT ASSETS
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NON-CURRENT ASSETS:
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Restricted long-term deposits and cash equivalents
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Property and equipment, net
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Operating lease right-of-use assets
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Other long-term assets
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Funds in respect of employee rights upon retirement
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TOTAL NON-CURRENT ASSETS
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TOTAL ASSETS
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$
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$
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Liabilities and shareholders' equity
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CURRENT LIABILITIES:
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Accounts payable
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$
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$
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Other accounts payable
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Current maturities of operating leases
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TOTAL CURRENT LIABILITIES
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LONG-TERM LIABILITIES:
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Operating leases liabilities
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Liability for employee rights upon retirement
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TOTAL LONG-TERM LIABILITIES
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TOTAL LIABILITIES $
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COMMITMENTS (Note 7)
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SHAREHOLDERS' EQUITY:
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Ordinary shares, NIS
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Additional paid-in capital
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Accumulated deficit
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(
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(
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TOTAL SHAREHOLDERS' EQUITY
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
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$
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$
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The accompanying notes are an integral part of these consolidated financial statements.
F-3
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
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Year ended December 31,
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2022
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2023
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2024
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REVENUES
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$
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$
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RESEARCH AND DEVELOPMENT EXPENSES
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GENERAL AND ADMINISTRATIVE EXPENSES
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OTHER INCOME, net
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TOTAL OPERATING LOSS
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(
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(
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(
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||||||
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FINANCIAL INCOME, net
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NET LOSS FOR THE YEAR
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(
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)
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(
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(
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BASIC AND DILUTED LOSS PER ORDINARY SHARE
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(
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)
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(
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(
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||||||
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WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE
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|||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-4
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share data)
| Ordinary shares |
Additional paid-
in capital |
Accumulated
deficit
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Total
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|||||||||||||||||
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Number
of shares
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Amounts
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Amounts | ||||||||||||||||||
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BALANCE AS OF JANUARY 1, 2022
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(
|
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CHANGES DURING 2022:
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Net loss for the year
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-
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(
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(
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Exercise of options
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Share-based compensation
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-
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BALANCE AS OF DECEMBER 31, 2022
|
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(
|
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CHANGES DURING 2023:
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Net loss for the year
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-
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(
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(
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Issuance of shares and warrants through public offering, net of issuance costs
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Issuance of shares and warrants through private placement from the controlling shareholder
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Exercise of options
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Share-based compensation
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-
|
|
|
|
|
|||||||||||||||
|
BALANCE AS OF DECEMBER 31, 2023
|
|
|
|
(
|
)
|
|
||||||||||||||
|
CHANGES DURING 2024:
|
||||||||||||||||||||
|
Net loss for the year
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
|
|
|
|
|||||||||||||||
|
BALANCE AS OF DECEMBER 31, 2024
|
|
|
|
(
|
)
|
|
||||||||||||||
* less than $1 thousand
The accompanying notes are an integral part of these consolidated financial statements.
F-5
SOL-GEL TECHNOLOGIES LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
|
Year ended December 31,
|
||||||||||||
|
2022
|
2023
|
2024
|
||||||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
|
Net loss for the year
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Adjustments required to reconcile net loss to net cash used in operating activities:
|
||||||||||||
|
Depreciation
|
|
|
|
|||||||||
|
Income from disposal of property and equipment
|
|
(
|
)
|
(
|
)
|
|||||||
|
Changes in accrued liability for employee rights upon retirement
|
|
|
(
|
)
|
||||||||
|
Share-based compensation expenses
|
|
|
|
|||||||||
|
Net changes in operating leases
|
(
|
)
|
|
(
|
)
|
|||||||
|
Changes in fair value of marketable securities
|
|
(
|
)
|
|
||||||||
|
Financial expenses (income), net
|
(
|
)
|
|
|
||||||||
|
Changes in operating asset and liabilities:
|
||||||||||||
|
Receivables from collaborative and licensing arrangements
|
|
|
|
|||||||||
|
Accounts receivables
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Prepaid expenses and other current assets
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Long-term receivables and other long-term assets
|
|
|
(
|
)
|
||||||||
|
Accounts payable and other accounts payable
|
(
|
)
|
|
|
||||||||
|
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
|
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
Proceeds from sale of property and equipment
|
|
|
|
|||||||||
|
Short-term deposits
|
|
|
|
|||||||||
|
Long-term deposits
|
|
(
|
)
|
|
||||||||
|
Investments in marketable securities
|
(
|
)
|
(
|
)
|
|
|||||||
|
Proceeds from sale and maturity of marketable securities
|
|
|
|
|||||||||
|
Net cash provided by (used in) investing activities
|
|
(
|
)
|
|
||||||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
|
Proceeds from exercise of options
|
|
|
|
|||||||||
|
Proceeds from issuance of shares and warrants through placement from the controlling shareholder
|
|
|
|
|||||||||
|
Proceeds from issuance of shares and warrants through public offering, net of issuance costs
|
|
|
|
|||||||||
|
Net cash provided by financing activities
|
|
|
|
|||||||||
|
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS
|
|
(
|
)
|
(
|
)
|
|||||||
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS
|
(
|
)
|
(
|
)
|
|
|||||||
|
CASH AND CASH EQUIVALENTS AND RESRICTED CASH EQUIVALENTS AT BEGINNING OF THE YEAR
|
|
|
|
|||||||||
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS AT END OF THE YEAR
|
|
|
|
|||||||||
|
Cash and Cash equivalents
|
|
|
|
|||||||||
|
Restricted cash equivalents included in restricted long-term deposits and cash equivalents
|
|
|
|
|||||||||
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH EQUIVALENTS SHOWN IN STATEMENT OF CASH FLOWS
|
|
|
|
|||||||||
|
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
|
||||||||||||
|
Recognition of new operating lease ROU and liabilities
|
|
|
|
|||||||||
|
SUPPLEMENTARY INFORMATION:
|
||||||||||||
|
Interest received
|
|
|
|
|||||||||
The accompanying notes are an integral part of these consolidated financial statements.
F-6
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share amounts)
NOTE 1 - NATURE OF OPERATIONS
Sol-Gel Technologies Ltd. (collectively with its U.S. subsidiary, the "Company") is an Israeli Company incorporated in 1997.
The Company is an innovative dermatology company with a successful track record of two NDA approvals and advanced orphan drugs pipeline. The Company has two approved drugs: (i) Twyneo®, which was developed for the treatment of acne vulgaris and received marketing authorization by the U.S. Food and Drug Administration (the "FDA") on July 27, 2021 and (ii) Epsolay®, a treatment for subtype II rosacea that received marketing authorization by the FDA on April 25, 2022. In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of Twyneo® and Epsolay®, in the United States, see Note 9a. On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician. In addition to the novel products, the Company’s products included the approved generic products Acyclovir, Ivermectin and other generic product candidates. In November 2021, the Company entered into an agreement with Padagis, to sell its rights in relation to ten generic collaborative agreements between the parties, including the agreements for the two aforementioned approved generic drug products. Under the new agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates. In August 15, 2024, the Company entered into a Termination Agreement ("the Agreement") with Padagis, according to which Padagis will pay to the Company $4,250 and future royalties, see Note 8b.
On January 27, 2023 the Company entered into an asset purchase agreement ("APA") with PellePharm, Inc. (hereafter - “PellePharm”), pursuant to which the Company agreed to purchase all of the assets related to the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome (such compound designated as investigational compound SGT-610). On January 30, 2023, upon closing of the transaction, the Company paid an upfront payment (hereafter - "upfront payment") of $4 million to PellePharm. The Company is required to pay an additional amount of $0.7 million, subject to the terms as defined in the APA, 15 months from the closing date, as of the date of the financial statements the amount was not paid. In addition, the Company will be required to pay total development and NDA acceptance milestones of up to $6 million, and up to $64 million in commercial milestones which amount increases to $89 million when sales exceed $500 million as well as single digit royalties which increase to double digit royalties when sales exceed $500 million.
During March 2024 the first development milestone event was completed and the Company recorded an amount of $500 as clinical expenses.
The upfront payment and the additional development milestone payments under the APA represent payments for research and development in-process ("IPR&D") acquired as part of an asset purchase, which has not reached technological feasibility and has no alternative future use. Accordingly, such payments are expensed as incurred and are recognized as research and development expenses.
On May 15, 2024, the Company and Shenzhen Beimei Pharmaceutical Co. Ltd. ("Beimei"), entered into an asset purchase agreement. For further details, see Note 9c.
On April 17, 2025, the Company entered into a product purchase agreement with a subsidiary of Mayne Pharma Group Limited (“Mayne Pharma”) for the sale and exclusive license of the U.S. rights to EPSOLAY and TWYNEO. Under the terms of the agreement, the Company is entitled to receive a total of $16 million in two installments: $10 million in the second quarter of 2025 and $6 million in the fourth quarter of 2025. This agreement was executed following the mutual termination by Sol-Gel and Galderma of the exclusive five-year license agreement in the U.S. for both products .
The Company has a wholly owned U.S. subsidiary - Sol-Gel Technologies Inc. (the "Subsidiary"), which supported the Company with marketing, regulatory affairs, and business development related to its products and technology in the United States. The Subsidiary ceased to operate in 2024.
F-7
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 1 - NATURE OF OPERATIONS (continued):
In October 2023, Israel was attacked by Hamas, a terrorist organization and entered a state of war. Since the commencement of these events, there have been additional active hostilities, including with Hezbollah in Lebanon, the Houthi movement which controls parts of Yemen, and with Iran. During January 2025, a cease fire with Hamas was declared. As of the date of these consolidated financial statements, the war is ongoing and continues to evolve. The Company's headquarters, its R&D operations, and certain manufacturing facilities are located in Israel. Currently, such activities in Israel remain largely unaffected.
As of the issuance date of this report, there was no material impact on the Company's ongoing operations in Israel. The Company continues to monitor its ongoing activities and will make any needed adjustments to ensure continuity of its business, while supporting the safety and well-being of its employees.
Risk and Uncertainties
Since incorporation through December 31, 2024, the Company has an accumulated deficit of approximately $230,883 and its activities have been funded mainly by its shareholders, collaboration revenues, sale of IP and license agreements, see also Notes 8 and 9. The Company expects to continue to incur significant research and development and other costs related to its ongoing operations.
Management expects that the Company's cash and cash equivalents, deposits and marketable securities (including the amounts to be received from the transaction with Mayne) will allow the Company to fund its operating plan through at least the next 12 months from the financial statement issuance date.
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
| a. |
Use of estimates in the preparation of financial statements
|
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results may differ from those estimates.
As applicable to these consolidated financial statements, the most significant estimates and assumptions relate to the fair value of share-based compensation and the incremental borrowing rate for leases.
| b. |
Functional and presentation currency
|
The U.S. dollar (“dollar”) is the currency of the primary economic environment in which the operations of the Company and its subsidiary are conducted. The Company’s financing has been provided in dollars, revenues are primarily in dollars and a significant part of expenses are incurred in dollars. The financial statements are presented in dollars, which is the Company’s functional and presentation currency.
Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (1) for transactions - exchange rates at transaction dates or average rates; and (2) for other items (derived from non-monetary balance sheet items such as depreciation) — historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate.
F-8
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| c. |
Cash and cash equivalents
|
The Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash.
| d. |
Bank deposits
Bank deposits with original maturity dates of more than three months but less than one year are included in short-term deposits. Such short-term deposits bear interest at an average annual rate of approximately |
Bank deposits with maturity of more than one year are considered long-term.
As of December 31, 2024, the Company has a restricted deposit in the amount of $1,176 in order to secure certain transactions with its banks. This amount is presented under restricted long-term deposits and cash.
| e. |
Marketable securities
|
Marketable securities consist of debt securities. The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis. Changes in fair value, realized gains and losses on sales of marketable securities, are reflected in the statements of operation as finance expense (income), net. Marketable securities are classified under current assets in the consolidated balance sheet as they represent the investment of funds available for the Company’s current operations.
| f. |
Derivatives and hedging
The Company carries out transactions involving foreign currency exchange derivative financial instruments. The transactions are designed to hedge the Company’s exposure in currencies other than the U.S. dollar. The derivatives do not qualify for hedge accounting, therefore the changes in the fair value are included in financial expense (income), net. The currency hedged items are denominated in New Israeli Shekel (NIS). The counterparties to the derivatives are major banks in Israel. |
| g. |
Accounts receivables
|
Accounts receivables are initially recognized at the transaction price and subsequently measured at amortized cost less any allowance for expected credit losses.
| h. |
Property and equipment
|
| 1) |
Property and equipment are stated at cost, net of accumulated depreciation and amortization.
|
| 2) |
The Company’s property and equipment are depreciated utilizing the straight-line method based on their estimated useful life.
|
F-9
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
Annual rates of depreciation are as follows:
|
%
|
|
|
Laboratory equipment
|
|
|
Office equipment and furniture
|
|
|
Computers and related equipment
|
|
Leasehold improvements are amortized utilizing the straight-line method over the shorter of the expected lease term or the estimated useful life of the improvements.
| i. |
Impairment of long-lived assets
|
The Company tests long-lived assets for impairment whenever events or circumstances present an indication of impairment. If the sum of expected future cash flows (undiscounted and without interest charges) of the assets is less than these assets' carrying amount, an impairment loss would be recognized. The assets would then be written down to their estimated fair values.
During the three years ended December 31, 2024, the Company did not recognize an impairment loss on its long-lived assets.
| j. |
Share-based compensation
|
The Company accounts for employees’ and non-employees' share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment compensation is recognized as an expense over the requisite service period.
The Company elected to recognize compensation costs for awards to employee conditioned only on continued service that have a graded vesting schedule using the accelerated method based on the multiple-option award approach.
The Company has elected to recognize forfeitures as they occur.
| k. |
Research and development expenses
|
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based compensation expenses, payroll taxes and other employee benefits, lab expenses, consumable equipment and consulting fees. All costs associated with research and developments are expensed as incurred.
Acquisitions of in-process research and development product candidates, which are not part of a business combination and that have no alternative use, are recognized as an expense as research and development expenses as incurred.
Grants received from Israel Innovation Authority (hereafter — “IIA”), formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry, or the OCS are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. See Note 7a(1).
F-10
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources its clinical trial activities utilizing external entities such as clinical research organizations, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical trials. Clinical trial costs are expensed as incurred.
| l. |
Revenue recognition
|
The Company applies ASC 606, Revenue from Contracts with Customers. According to the standard, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the performance obligation is satisfied.
An entity only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer, after considering any price concession expected to be provided to the customer, as applicable. At contract inception, the entity assesses the goods or services promised within each contract, determines whether they are performance obligations and assesses whether each promised good or service is distinct. A good or service promised to a customer is distinct if the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. The entity then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Collaborative Arrangements
The Company entered into collaborative arrangements with partners that fall under the scope of Topic 808, Collaborative Arrangements (“ASC 808”). While these arrangements are in the scope of ASC 808, the Company may analogize to ASC 606 for some aspects of the arrangements. The Company analogizes to ASC 606 for certain activities within the collaborative arrangement for the delivery of a good or service (i.e., a unit of account) that is part of its ongoing major or central operations.
The terms of the Company’s collaborative arrangements typically include one or more of the following: (i) royalties on net sales of licensed products; (ii) reimbursements or cost-sharing of R&D expenses. Each of these payments results in collaboration revenues or an offset against R&D expense.
Under certain collaborative arrangements, the Company has been reimbursed for a portion of its R&D expenses or participates in the cost-sharing of such R&D expenses. Such reimbursements and cost-sharing arrangements have been reflected as a reduction of R&D expense in the Company’s consolidated statements of operations, as the Company does not consider performing research and development services for reimbursement to be a part of its ongoing major or central operations.
F-11
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| l. |
Revenue recognition (continued):
|
For arrangements that include a significant financing component, the company separates the significant financing component from the revenue and interest income is recorded, See Note 8.
Licensing agreements
The Company has license agreements with two parties, Galderma and Searchlight.
In its license agreements with Galderma, the Company has identified one performance obligation (see Note 9a): grant of the license and use of its IP. The grant of the license and use of its IP performance obligation is considered to be a right to use IP in accordance with ASC 606. Therefore, revenue is recognized at a point in time, upon transfer of control over the license to the licensee.
In its license agreements with Searchlight (see Note 9b), the Company has identified two performance obligations: grant of the license and use of its IP, as well as continuing support during the regulatory approval process. The grant of the license is recognized at a point in time, upon transfer of control over the license to the licensee, while the services are recognized over time as the services are performed.
ASC 606 defines the ‘Transaction Price’ as the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services to a customer. License agreements may contain variable consideration contingent upon the licensee achieving certain milestones, as well as sales-based royalties, in accordance with the relevant agreement. Variable payments, contingent on achieving additional milestones, are included in the transaction price based on most likely amount method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur, usually upon achievement of the specific milestone, in accordance with the relevant agreement. Sales-based royalties are not included in the transaction price. Rather, they are recognized as the related sale occurs, due to the specific exception of ASC 606 for sales-based royalties in licensing of intellectual properties.
Sale of IP agreements
The Company has Sale and license agreements for IP with Beimei (see Note 9c).
According to ASC 606 an entity's promise to provide a customer with the right to use its intellectual property is satisfied at a point in time. The entity should determine the point in time at which the license transfers to the customer.
The Company provides Beimei a right to use the entity's intellectual property as it exists at the point in time at which the license is granted and therefore should recognized revenue at a point of time upon transfer of control over the license and the IP to Beimei. The transfer of control over the license and IP occurred shortly after the signing of the agreement.
The Company is not expected to have ongoing involvement after the transfer of the license to Beimei that is expected to affect Beimei ability to use the license and IP.
The Company provides further support services to Beimei based on agreed upon rates. The company recognized revenue regarding the support services performance obligation over time, according to ASC 606, since Beimei simultaneously receives and consumes the benefits provided by the Company's performance as the entity performs.
Variable consideration in Beimei's transaction (such as payments, contingent on achieving additional milestones and sales-based royalties), are included in the transaction price based on most likely amount method or expected value method, as appropriate, and included in the transaction price when it is probable that a significant reversal of cumulative revenues will not occur.
F-12
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| m. |
Income taxes
|
| 1) |
Deferred taxes
|
The Company accounts for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”). ASC 740 prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all of the deferred tax assets will not be realized, based on the weight of available positive and negative evidence. Deferred tax liabilities and assets are classified as non-current.
| 2) |
Uncertainty in income taxes
|
The Company follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50% likelihood of being realized upon ultimate settlement.
| n. |
Leases
|
Right of use ("ROU") assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. The Company’s lease terms may include periods covered by options to extend or terminate the lease when it is reasonably certain that the Company will exercise the option to extend the lease or not exercise the option to terminate the lease.
The Company uses the implicit rate when readily determinable. As the Company’s leases do not provide an implicit rate, the Company uses its estimated incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. Lease expense for operating lease is recognized on a straight-line basis over the lease term. The Company elected to not separate lease and non-lease components for the leases. The Company elected the practical expedient of the short-term lease recognition exemption for all leases with a term shorter than 12 months.
Additionally, the company applies the portfolio approach to account for operating lease ROU asset and liabilities for certain car leases and incremental borrowing rates.
F-13
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| o. |
Concentration of credit risks
|
Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash and cash equivalents, bank deposits, marketable securities and certain receivables. The Company deposits cash and cash equivalents with highly rated financial institutions. In addition, all marketable securities either carry a high rating or are government insured. The Company has not experienced any material credit losses in these accounts and does not believe it is exposed to significant credit risk on these instruments.
| p. |
Loss per share
|
Basic loss per share is computed based on net loss for the period divided by the weighted average number of ordinary shares outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of potential ordinary shares outstanding when dilutive. Potential ordinary shares include outstanding stock options and warrants, which are included under the treasury stock method when dilutive.
The calculation of diluted loss per share does not include 3,900,837 , 7,070,688 and 6,265,104 options and warrants for the years ended December 31, 2022, 2023 and 2024, respectively, because their effect would be anti-dilutive.
| q. |
Fair value measurement
|
Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.
The fair value of bank deposits approximates their carrying value, since they bear interest at rates close to the prevailing market rates. In addition, due to the short-term nature and/or low-risk nature of the Company's cash and cash equivalents, restricted cash equivalents, accounts receivable, accounts payable and other payables, their carrying amounts approximate their fair value.
F-14
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
| r. |
Recently adopted accounting pronouncement
|
In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under ASC 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company adopted this standard in the current period retrospectively to all prior periods presented in an entity’s financial statements, refer to note 14.
| s. |
Newly issued accounting pronouncements, not yet adopted:
|
| 1) |
In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
|
| 2) |
In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
|
NOTE 3 - MARKETABLE SECURITIES:
The following table sets forth the Company’s marketable securities for the indicated period:
|
December 31,
|
||||||||
|
2023
|
2024
|
|||||||
|
Level 2 securities:
|
||||||||
|
U.S government and agency bonds
|
$
|
|
$
|
|
||||
|
Other foreign government bonds
|
|
|
||||||
|
Corporate bonds*
|
|
|
||||||
|
Total
|
$
|
|
$
|
|
||||
* Investments in Corporate bonds rated A or higher.
The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis.
The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value.
The cost of marketable securities as of December 31, 2024 is $4,309 .
F-15
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 3 - MARKETABLE SECURITIES (continued):
The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the years ended December 31, 2023 and 2024:
|
December 31,
|
||||||||
|
2023
|
2024
|
|||||||
|
Balance at beginning of the year
|
$
|
|
$
|
|
||||
|
Additions
|
|
|
||||||
|
Sale or maturity
|
(
|
)
|
(
|
)
|
||||
|
Changes in fair value during the year
|
|
(
|
)
|
|||||
|
Balance at end of the year
|
$
|
|
$
|
|
||||
As of December 31, 2024, all the Company’s debt securities have maturity dates within one year.
NOTE 4 - PROPERTY AND EQUIPMENT
|
|
December 31
|
|||||||
|
|
2023
|
2024
|
||||||
|
Cost:
|
||||||||
|
Laboratory equipment
|
$
|
|
$
|
|
||||
|
Office equipment and furniture
|
|
|
||||||
|
Computers and software
|
|
|
||||||
|
Leasehold improvements
|
|
|
||||||
|
|
|
|||||||
|
Less:
|
||||||||
|
Accumulated depreciation and amortization
|
(
|
)
|
(
|
)
|
||||
|
Property and equipment, net
|
$
|
|
$
|
|
||||
Depreciation and amortization expense totaled $562 , $342 and $233 for the years ended December 31, 2022, 2023 and 2024, respectively.
During 2023 the Company has sold Equipment which its total cost was $ 271 . The gain from the sell of the Equipment recorded as other income in total amount of $55 .
NOTE 5 - LEASES:
The Company leases offices and vehicles under operating leases. For leases with terms greater than 12 months, the Company records right of use assets and lease liabilities at the present value of lease payments over the leases term.
Offices
The Company leases office spaces and research and development facilities under several agreements. These agreements are linked to the change in the Israeli consumer price index and were to expire in . In June 2023, the Company signed on extension to the office lease agreement, for the period starting January 1, 2024 for an additional period of two years, with an option to extend the agreement for another two years, meaning a maximum extension period of four years . These agreements are classified as operating leases and are presented under operating lease right-of-use assets and operating leases liabilities. A restricted deposit of $116 has been deposited in order to secure the agreement.
F-16
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 5 - LEASES (continued):
Vehicles
The Company has entered into operating lease agreements for vehicles used by its employees for a period of 3 years . These contracts are classified as operating leases and presented under operating lease right-of-use assets and operating leases liabilities.
Lease Position
The table below presents the lease-related assets and liabilities recorded on the consolidated balance sheet:
|
As of
December 31,
|
||||||||
|
2023
|
2024
|
|||||||
|
Assets
|
||||||||
|
Operating Leases
|
||||||||
|
Operating lease right-of-use assets
|
|
|
||||||
|
Liabilities
|
||||||||
|
Current liabilities
|
||||||||
|
Current maturities of operating leases
|
|
|
||||||
|
Long-term liabilities
|
||||||||
|
Non-current operating leases
|
|
|
||||||
|
Weighted Average Remaining Lease Term
|
||||||||
|
Operating leases
|
|
|
||||||
|
Weighted Average Discount Rate
|
||||||||
|
Operating leases
|
|
%
|
|
%
|
||||
Lease Costs
The table below presents certain information related to lease costs of operating leases:
|
Year Ended
December 31,
|
||||||||
|
2023
|
2024
|
|||||||
|
Operating lease cost:
|
|
|
||||||
The table below presents supplemental cash flow information related to leases:
|
Year Ended
December 31,
|
||||||||
|
2023
|
2024
|
|||||||
|
Cash paid for amounts included in the measurement of leases liabilities:
|
||||||||
|
Operating cash flows from operating leases
|
|
|
||||||
F-17
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 5 - LEASES (continued):
Undiscounted Cash Flows
The table below reconciles the undiscounted cash flows under leases as of December 31, 2024 were as follows:
|
Operating
Leases
|
||||
|
For the year ending December 31,
|
||||
|
2025
|
|
|||
|
2026
|
|
|||
|
2027 and thereafter
|
|
|||
|
Total minimum lease payments
|
|
|||
|
Less: amount of lease payments representing interest
|
|
|||
|
Present value of future minimum lease payments
|
|
|||
|
Less: Current maturities of operating leases
|
|
|||
|
Long-term operating leases liabilities
|
|
|||
NOTE 6 - EMPLOYEE SEVERANCE BENEFITS:
The Company is required to make severance payments upon dismissal of an employee or upon termination of employment in certain circumstances.
In accordance with the current employment terms starting in August 2014 with all of its employees (Section 14 of the Israeli Severance Pay Law, 1963), the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s retirement benefit obligation. The Company is fully relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected in the Company balance sheet, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies (the “Contribution Plan”).
For employees whose employment term began prior to August 2014, the severance payment liability (based upon length of service and the latest monthly salary — one month’s salary for each year employed) is recorded on the Company’s balance sheet under “Liability for employee rights upon retirement". The liability is recorded as if it was payable at each balance sheet date on an undiscounted basis.
This liability is funded in part from the purchase of insurance policies or by the establishment of pension funds with dedicated deposits in the funds. The amounts used to fund these liabilities are included in the balance sheets under “Funds in respect of employee rights upon retirement.” These policies are the Company’s assets.
The amounts of severance payment expenses were $461 , $445 and $343 for the years ended December 31, 2022, 2023 and 2024, respectively, of which $405 , $389 and $293 in the years ended December 2022, 2023 and 2024, respectively, were in respect of the Contribution Plan.
The Company expects to contribute approximately $302 in the year ending December 31, 2025 to insurance companies in connection with its expected severance liabilities for that year.
F-18
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 7 - COMMITMENTS:
| a. |
Royalty Commitments:
|
| 1) |
The Company is obligated to pay royalties to the IIA on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from the IIA.
|
Under the specific terms of the funding arrangements with the IIA, royalties of 3.5 % to 25 % are payable on the sale of products developed with funding received from the IIA, which payments shall not exceed, in the aggregate, 300 % of the amount of the grant received (dollar linked), plus interest at annual rate based on the 12-month SOFR rate as published by CME Group on the first day of commerce or any other body certified by the Federal Reserve, or according to an alternative bulletin as published by the Bank of Israel.
Up to December 31, 2024, the Company had recognized and received grants from the IIA in the aggregate amount of $1,430 (no grants were received in the years ended December 31, 2022, 2023 and 2024). Through December 31, 2024, the Company recorded an accumulated royalty expense of $2,228 as royalties to the IIA with respect to revenue recognized through December 31, 2024 ($39 , $37 and $36 were recorded in 2022, 2023 and 2024 accordingly, as an expense in the consolidated statements of operations).
| 2) |
The Company has an agreement, that was amended several times (hereafter — the agreements) with Yissum Research Development Company (hereafter — “Yissum”), the technology-licensing arm of the Hebrew University of Jerusalem.
|
According to the agreements, the Company received from Yissum an exclusive and a non-exclusive license for the commercialization of certain Yissum patents. According to the agreements the Company shall pay Yissum:
Royalties of 1.5 % of net sales related to certain patents. 1.5 % – 8 % of proceeds received by the Company for the sublicense or license of certain patents.
Royalty expenses in immaterial amounts were recorded in 2022, 2023 and 2024 in respect of these agreements.
According to the agreements, the Company may continue commercial use of certain Yissum’s patents in connection with the products and subject to the obligation to pay Yissum the royalties and the sub-license fees.
The Company granted rights to a third party for use and commercialization of certain Yissum patents.
| b. |
As to collaboration agreements, see detailed information in Note 8.
|
F-19
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 8 - COLLABORATION AGREEMENTS:
| a. |
In 2007, the Company sublicensed rights to a third party for use and commercialization of a product for skin protection. Under this agreement, the Company is entitled to royalties during the years
|
| b. |
In 2016 through 2020, the Company entered into several collaboration agreements mainly with one third party (the "Partner") for the development, manufacturing and commercialization of several product candidates (including an agreement assumed by the Company in August 2018, following the transfer of an in-process research and development product candidate from a related party).
|
Under the agreements, the Partner is obligated to conduct regulatory, scientific, clinical and technical activities necessary to develop the product and prepare and file an abbreviated new drug application ("ANDA"), with the FDA and gain regulatory approval. The Company participates in the development of the product candidates, including participation in joint steering committees and is obligated for sourcing the active pharmaceutical ingredient (API) during the development phase.
In November 2021, the Company entered into a new agreement ("New Agreement") with the Partner, to sell its rights to the Partner in relation to ten generic collaborative agreements between the parties in consideration of $21,500 which was paid over 24 months. Under the New Agreement, the Company has retained collaboration rights to two generic programs (Roflumilast cream and Roflumilast foam) related to four generic drug candidates, and is no longer entitled to receive its share in profit as detailed above.
In addition, the Company ceased paying any outstanding and future operational costs related to these collaborative agreements.
In August 15, 2024, the Company entered into a Termination Agreement ("the Agreement") with the Partner. The purpose of the Agreement is to terminate the Development, Manufacturing and Commercialization Agreement dated June 28, 2020, and to sell its rights to the Partner in relation to Roflumilast cream and Roflumilast foam. As consideration for the Agreement between the parties, the Partner will pay to the Company $4,250 , which will paid in eight quarterly installments. In addition, in the end of each quarter for five years as of the Launch Date (the date of first commercial sale of the Product in the Territory by the Partner or its Affiliates pursuant to the ANDA), the Partner shall pay Sol-Gel 2 % royalties of the Partner’s Gross Profits for that Product.
The Company has identified one performance obligation in the agreement. Revenue from sale of IP is recognized at a point in time, upon transfer of control over the sale of IP to the Partner. Royalties from sale of IP are included in the transaction price based on expected value method and included in the transaction price only when it is probable that a significant reversal of cumulative revenues will not occur. For the year ended December 31, 2024, the Company recognized revenue for a total amount of $3.8 million which is measured on a present value basis. This amount does not include variable consideration that was determined to be constrained (not probable that would not result in a significant reversal).
F-20
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 9 - LICENSE AGREEMENTS:
| a. |
In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of two of the Company's most advanced investigational drug products (Twyneo® and Epsolay®) in the United States. The Company is entitled to amounts of up to $
|
According to the agreement, the Company has an option to regain commercialization rights five years following first commercialization.
On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician, see further details in Note 1. In March 2022, the Company had refunded the $4 million upfront payment to Galderma, since FDA approval for Epsolay® had not been received as of December 31, 2021. On April 25, 2022, the Company announced that the FDA approved the drug product, Epsolay®, which entitled the Company to a $3.5 million milestone payment, as per the license agreement. In
May 2022, the Company has received the $3.5 million payment from Galderma. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician, see further details in Note 1. During 2023 and 2024, the Company recognized $1,027 and $1,482 , respectively, as revenue from royalties in respect of the license agreement for both products.
| b. |
On June 6, 2023, the Company and Searchlight Pharma Inc. (“Searchlight”), a private Canadian specialty pharmaceutical company, signed on an exclusive license agreements for Twyneo® and Epsolay® for the Canadian market, over
|
Under the agreement, the Company will receive up to $11 million in upfront payments and regulatory and sales milestones for both drugs, combined. In addition, the Company will be entitled to royalty percentages of all Canadian net sales ranging from low-double-digits to high teens.
In June 2023, the Company received $500 as an upfront payment in connection with the license agreement and related support provided to Searchlight for obtaining the regulatory approval in the Canadian market. The Company is also required to support Searchlight during the license period if needed based on agreed upon rates. The Company has identified two performance obligations in the license agreement as follows: (i) the license to market the products in Canada; and (ii) continuing support during the regulatory approval process.
The Company recorded a contract liability in respect of the support services of $120 and $64 as of December 31, 2023 and December 31, 2024, respectively.
The Company recognized $380 and $625 as license revenue in 2023 and 2024, respectively.
| c. |
On May 15, 2024, the Company and Beimei, a private Chinese company, signed an agreement for the purchase and license by Beimei of certain rights in the intellectual property (in which the sale is deemed to be the predominant item – both hereafter "IP") related to Twyneo, for the treatment of acne vulgaris, in the mainland of China, Hong Kong, Macau, Taiwan and Israel.
|
Under the terms of the agreement, Beimei will purchase and license from the Company the IP in these territories. The Company is also required to support Beimei to a certain extent during the period until obtaining regulatory approval. The Company provides further support services to Beimei based on agreed upon rates. In return, Sol-Gel is to receive payments of up to $10 million (including amounts contingent on achieving certain milestones) and up to $5 million as royalty payments on net sales.
F-21
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 9 - LICENSE AGREEMENTS (continued):
The Company has identified multiple performance obligations in the agreement. Revenue from sale and license of IP is recognized at a point in time, upon transfer of control over the license and the IP to Beimei. Support services are recognized over time as the services are performed.
For the year ended December 31, 2024, the Company recognized revenue of an amount of $4.8 million for sale of IP and the license.. This amount does not include variable consideration that was determined to be constrained (not probable that would not result in a significant reversal). In addition, the Company allocated $200 to the support services to be recognized over time. For the year ended December 31, 2024, the Company recognized a total amount of $70 for support.
As of December 31, 2024, the contract liability in respect of the support services is at the amount of $130 .
In July and November 2024, the Company received $2.0 million and $1.5 million, respectively in connection with the agreement.
NOTE 10 - SHARE CAPITAL:
| a. |
Ordinary shares |
Rights of the Company’s ordinary shares
Each ordinary share is entitled to one vote. The holder of an ordinary share is also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. Since its inception, the Company has not declared any dividends.
| 1) |
In July 2021, the Company entered into an At The Market (“ATM”) sales agreement ("2021 ATM Agreement") with Jefferies LLC ("Jefferies"), pursuant to which the Company was entitled, at its sole discretion, to offer and sell through Jefferies, acting as sales agent, shares having an aggregate offering price of up to $
|
Under the 2021 ATM Agreement, 41,154 shares were sold under the program for total gross proceeds of approximately $0.5 million. On April 2022, the Company terminated the 2021 ATM Agreement, effective on the same date.
| 2) |
On January 27, 2023, the Company entered into a securities purchase agreement (hereafter - “Purchase Agreement”) with Armistice Capital, pursuant to which the Company issued to Armistice Capital (i)
|
Concurrently with the signing of the Purchase Agreement, the Company also entered into a subscription agreement (hereafter - “Subscription Agreement”) between the Company and M. Arkin Dermatology Ltd., the Controlling Shareholder of the Company, pursuant to which M. Arkin Dermatology Ltd. agreed to purchase 2,000,000 unregistered Ordinary Shares and unregistered warrants to purchase up to 2,000,000 ordinary shares (the “PIPE Warrants” and, together with the Investor Warrants, the “Warrants”) in a concurrent private placement (hereafter- “Affiliate Private Placement"), at a price equal to the offering price of the Ordinary Shares in the Offering. The Affiliate Private Placement agreement was contingent on certain conditions and was approved by the Company’s shareholders in March 2023. The total proceeds of $10,000 were received in April 2023.
F-22
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 10 - SHARE CAPITAL (continued):
| b. |
Share-based compensation:
|
| 1) |
Option plan
|
In December 2014, the Company’s Board of Directors approved a share incentive plan (hereafter — the Plan) and reserved a pool of
In March 2023, the Company’s Board of Directors approved an increase of the ordinary shares that may be issued under the Company’s Plan by reserving an additional amount of 1,250,000 ordinary shares.
The Plan is designed to enable the Company to grant awards to purchase ordinary shares under various and different tax regimes including, without limitation: pursuant and subject to Section 102 of the Israeli Tax Ordinance, pursuant and subject to Section 3(i) of the Israeli Tax Ordinance and under Internal Revenue Code Section 422.
The awards may be exercised after vesting and in accordance with vesting schedules which will be determined by the Board of Directors for each grant. The maximum term of the awards is 10 years. The fair value of each option granted under the Plan is estimated using the Black-Scholes option pricing method. Expected volatility is based on the historical volatility of the company.
The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the options granted in dollar terms. The expected term of the options is estimated based on the simplified method, as its historical experience for options grants as a public company is insufficient.
In December 2019, the Company’s Board of Directors approved an increase of the ordinary shares that may be issued under the Company’s Plan by reserving an additional amount of 912,230 ordinary shares.
As of December 31, 2024, 778,028 ordinary shares remain available for future grants under the Plan.
| 2) |
Options grants
|
|
| a. |
Option granted to employees and directors
|
During the twelve months ended December 31, 2024, the Company granted 325,000 options to Directors and executive officer:
| i. |
In January 2024, the board of directors approved and recommended the Company's shareholders to approve a grant of
The options vest over a period of
|
F-23
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 10 - SHARE CAPITAL (continued):
The fair value of options granted was $207 . The underlying data used for computing the fair value of the options are as follows:
|
2024
|
|
|
Value of one ordinary share
|
$
|
|
Dividend yield
|
|
|
Expected volatility
|
|
|
Risk-free interest rate
|
|
|
Expected term
|
|
| ii. |
In July 2024, the Company granted a total of
|
The options vest over a period of 4 years; one quarter of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following three years. The options expire on the tenth anniversary of their grant date.
The fair value of options granted was $16 The underlying data used for computing the fair value of the options are as follows:
|
2024
|
|
|
Value of one ordinary share
|
$
|
|
Dividend yield
|
|
|
Expected volatility
|
|
|
Risk-free interest rate
|
|
|
Expected term
|
|
The weighted average fair value of options granted in 2023 was $2.01 . The underlying data used for computing the fair value of the options are as follows:
|
2023
|
|
|
Value of one ordinary share
|
$
|
|
Dividend yield
|
|
|
Expected volatility
|
|
|
Risk-free interest rate
|
|
|
Expected term
|
|
The total unrecognized compensation cost of employee options at December 31, 2024 is $476 , which is expected to be recognized over a period of 3.53 years.
F-24
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 10 - SHARE CAPITAL (continued):
The following table summarizes the number of options granted to employees under the Plan for the year ended December 31, 2024, and related information:
|
Year ended December 31
|
||||||||||||||||||||||||
|
2023
|
2024
|
|||||||||||||||||||||||
|
Number
of
options
|
Weighted
average
exercise
price
|
Weighted
average
remaining
contractual
life
|
Number
of
options
|
Weighted
average
exercise
price
|
Weighted
average
remaining
contractual
life
|
|||||||||||||||||||
|
Options outstanding at the beginning of the year
|
|
$
|
|
|
|
$
|
|
|
||||||||||||||||
|
Granted
|
|
$
|
|
|
|
$
|
|
|
||||||||||||||||
|
Exercised
|
(
|
)
|
$
|
|
-
|
-
|
-
|
-
|
||||||||||||||||
|
Expired
|
(
|
)
|
$
|
|
-
|
(
|
)
|
$
|
|
-
|
||||||||||||||
|
Forfeited
|
(
|
)
|
$
|
|
-
|
(
|
)
|
$
|
|
-
|
||||||||||||||
|
Options outstanding at the end of the year
|
|
$
|
|
|
|
$
|
|
|
||||||||||||||||
|
Options exercisable at the end of the year
|
|
$
|
|
|
|
$
|
|
|
||||||||||||||||
| b. |
Option granted to non-employees |
All compensation cost of non-employees' options were fully recognized as of December 31, 2024.
The following table summarizes the number of options granted to non-employees under the Plan as of December 31, 2024, and related information (no options were granted to non-employees in 2024):
|
December 31
|
||||||||||||
|
2024
|
||||||||||||
|
Number of options
|
Weighted average exercise price
|
Weighted average remaining contractual life
|
||||||||||
|
Options outstanding at the end of the year
|
|
$
|
|
|
||||||||
|
Options exercisable at the end of the year
|
|
$
|
|
|
||||||||
The following table illustrates the effect of share-based compensation on the statements of operations:
|
Year ended
December 31 |
||||||||||||
|
2022
|
2023
|
2024
|
||||||||||
|
Research and development expenses
|
$
|
|
$
|
|
$
|
|
||||||
|
General and administrative expenses
|
$
|
|
$
|
|
$
|
|
||||||
|
$
|
|
$
|
|
$
|
|
|||||||
F-25
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 11 - TAXES ON INCOME:
| a. |
Tax rates in Israel
|
The Company is taxed in accordance with Israeli tax laws. The corporate tax rates applicable to 2022, 2023 and 2024 is 23
| b. |
Tax rates for the U.S Subsidiary
|
The subsidiary is taxed according to U.S. tax laws. The Company’s income is taxed in the United States at the federal rate of 21 %.
| c. |
Tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Investment Law”)
|
Under the Investment Law, including Amendment No. 60 to the Investment Law that was published in April 2005, by virtue of the Benefited Enterprise program for certain of its facilities; the Company may be entitled to various tax benefits.
The main benefit arising from such status is the reduction in tax rates on income derived from a Benefited Enterprise. The extent of such benefits depends on the location of the enterprise. Since the Company’s facilities are not located in “national development zone A,” income derived from Benefited Enterprises will be tax exempt for a period of two years and then have a reduced tax rate for a period of up to an additional eight years.
The period of tax benefits, as described above, is limited to 12 years from the beginning of the Benefited Enterprise election year (2012). As of December 31, 2024, the period of benefits has not yet commenced.
In the event of distribution of cash dividends from income, which was tax exempt as above, the amount distributed will be subject to the tax rate it was exempted from. The Company is entitled to claim accelerated depreciation in respect of equipment used by the approved enterprises during five tax years.
Entitlement to the above benefits is conditioned upon the Company fulfilling the conditions stipulated by the Investment Law and regulations published thereunder.
In the event of failure to comply with these conditions, the benefits may be canceled, and the Company may be required to refund the amount of the benefits, in whole or in part, with the addition of linkage differences to the Israeli consumer price index and interest.
The Investment Law was amended as part of the Economic Policy Law for the years 2011 – 2012 (the “Amendment”), which became effective on January 1, 2011 and was further amended in August 2013 and January 2017.
Under the 2017 Amendment, and provided the conditions stipulated therein are met, income derived by Preferred Companies from ‘Preferred Technological Enterprises’ (“PTE”) (as defined in the 2017 Amendment), would be subject to reduced corporate tax rates of 7.5% in Development Zone “A” and 12% elsewhere, or 6% in case of a ‘Special Preferred Technological Enterprise’ (“SPTE”) (as defined in the 2017 Amendment) regardless of the company’s geographical location within Israel. A Preferred Company distributing dividends from income derived from its PTE or SPTE, would subject the recipient to a 20% tax (or lower, if so provided under an applicable tax treaty). The 2017 Amendment further provides that, in certain circumstances, a dividend distributed to a corporate shareholder who is not an Israeli resident for tax purposes would be subject to a 4% tax (inter alia, if the amount of foreign investors in the distributing company exceeds 90%). Such taxes would generally be withheld at source by the distributing company.
F-26
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 11 - TAXES ON INCOME (continued):
On June 14, 2017, the Encouragement of Capital Investments Regulations (Preferred Technology Income and Capital Profits for a Technological Enterprise), 2017 (the “Regulations”) were published, which adopted Action 5 under the base erosion and profit shifting (“BEPS”) regulations. The Regulations describe, inter alia, the mechanism used to determine the calculation of the benefits under the PTE and under the SPTE Regime and determine certain requirements relating to documentation of intellectual property for the purpose of the PTE. According to these provisions, a company that complies with the terms under the PTE regime may be entitled to certain tax benefits with respect to income generated during the company’s regular course of business and derived from the preferred intangible asset (as determined in the Investments Law), excluding income derived from intangible assets used for marketing and income attributed to production activity. In the event that intangible assets used for marketing purposes generate over 10% of the PTE’s income, the relevant portion, calculated using a transfer pricing study, would be subject to regular corporate income tax. If such income does not exceed 10%, the PTE will not be required to exclude the marketing income from the PTE’s total income. The Regulations set a presumption of direct production expenses plus 10% with respect to income related to production, which can be countered by the results of a supporting transfer pricing study. Tax rates applicable to such production income expenses will be similar to the tax rates under the Preferred Enterprise regime, to the extent such income would be considered as eligible. In order to calculate the preferred income, the PTE is required to take into account the income and the research and development expenses that are attributed to each single preferred intangible asset. Nevertheless, it should be noted that the transitional provisions allow companies to take into account the income and research and development expenses attributed to all of the preferred intangible assets they have.
Under the transitional provisions of the law, a company is allowed to continue to enjoy the tax benefits available under the law prior to its amendment until the end of the period of benefits, as defined in the law. In each year during the period of benefits as a Benefited Enterprise, the Company will be able to opt for application of the amendment, thereby making available the tax rates discussed above. The Company’s election to apply the amendment is irrecoverable.
As of December 31, 2024, the Company’s management decided not to adopt the application of the Amendment.
There is no assurance that future taxable income of the Company will qualify as benefited or preferred income or that the benefits described above will be available to the Company in the future.
| d. |
Tax assessments
|
Tax assessments filed by the Company through the year 2019 are considered to be final.
| e. |
Losses for tax purposes carried forward to future years
|
As of December 31, 2024, the Company had approximately $196.3 million of net carry forward tax losses which are available to reduce future taxable income with no limited period of use.
F-27
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 11 - TAXES ON INCOME (continued):
| f. |
Deferred income taxes:
|
|
December, 31
|
||||||||
|
2023
|
2024
|
|||||||
|
In respect of:
|
||||||||
|
Net operating loss carry forward
|
$
|
|
$
|
|
||||
|
Research and development expenses
|
|
|
||||||
|
Other
|
|
|
||||||
|
Less – valuation allowance
|
(
|
)
|
(
|
)
|
||||
|
Net deferred tax assets
|
$
|
|
$
|
|
||||
| g. |
Reconciliation of theoretical tax expenses to actual expenses
|
Actual tax expenses are in respect of the U.S. subsidiary. The primary reconciling items between the statutory tax rate of the Company and the effective rate are the full valuation allowance of deferred tax assets and nondeductible expenses in relation to the operations in Israel.
| h. | Roll forward of valuation allowance |
|
Balance as of January 1, 2022
|
$
|
|
||
|
Deductions
|
(
|
)
|
||
|
Balance as of December 31, 2022
|
$
|
|
||
|
Additions
|
|
|||
|
Balance as of December 31, 2023
|
$
|
|
||
|
Additions
|
|
|||
|
Balance as of December 31, 2024
|
$
|
|
| i. | Provision for uncertain tax positions |
As of December 31, 2023 and 2024, the Company does not have a provision for uncertain tax positions.
NOTE 12 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION
Other accounts payables and accruals:
|
December, 31
|
||||||||
|
2023
|
2024
|
|||||||
|
Accrued expenses
|
$
|
|
$
|
|
||||
|
Employees payables
|
|
|
||||||
|
APA payable (see note 1)
|
|
|
||||||
|
Other
|
|
|
||||||
|
$
|
|
$
|
|
|||||
F-28
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 12 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (continued):
Revenue:
|
December, 31
|
||||||||||||
|
2022
|
2023
|
2024
|
||||||||||
|
Royalties revenue
|
$
|
|
$
|
|
$
|
|
||||||
|
Sale of IP and license revenue
|
|
|
|
|||||||||
|
Support services
|
|
|
|
|||||||||
|
Total revenue
|
$
|
|
$
|
|
$
|
|
||||||
Research and development expenses:
|
December, 31
|
||||||||||||
|
2022
|
2023
|
2024
|
||||||||||
|
Payroll and related expenses
|
$
|
|
$
|
|
$
|
|
||||||
|
Clinical and preclinical trials expenses
|
|
|
|
|||||||||
|
Professional consulting and subcontracted work
|
|
|
|
|||||||||
|
Other
|
|
|
|
|||||||||
|
$
|
|
$
|
|
$
|
|
|||||||
NOTE 13 - RELATED PARTIES
| a. |
Related parties include the controlling shareholder and companies under his control, the Board of Directors and the executive officers of the Company.
|
| b. |
As to options and restricted shares granted to directors and executive officers, see Note 10b(2).
|
| c. |
As to the Subscription Agreement with the controlling shareholder, see Note 10a(2).
|
| d. |
On December 31, 2024, the CEO terminated his employment agreement, and starting in January 2025 he will serve as a consultant.
|
NOTE 14 - SEGMENTS
Our chief operating decision maker (“CODM”), the Chief Executive Officer, manages the Company’s business activities as a single operating and reportable segment at the consolidated level. Accordingly, our CODM uses consolidated net income to measure segment profit or loss, allocate resources and assess performance based on consolidated net income which is consistent with the basis the consolidated statements of operations are presented. In addition, the CODM examines research and development expenses separately in order to make operating decisions. For additional information regarding research and development expenses, see note 12.
F-29
SOL-GEL TECHNOLOGIES LTD.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
(U.S. dollars in thousands, except share and per share amounts)
NOTE 15 - ENTITY-WIDE DISCLOSURE:
| 1) |
Revenues by geographic area were as follows:
|
|
Year ended December 31
|
||||||||||||
|
2022
|
2023
|
2024
|
||||||||||
|
China
|
$
|
|
$
|
|
$
|
|
||||||
|
Israel
|
|
|
|
|||||||||
|
Switzerland
|
|
|
|
|||||||||
|
Canada
|
|
|
|
|||||||||
|
Other
|
|
|
|
|||||||||
|
$
|
|
$
|
|
$
|
|
|||||||
| 2) |
All Company’s property, plant and equipment, right of use assets and other long-term assets are located in Israel.
|
NOTE 16 – SUBSEQUENT EVENTS:
| a. |
Regarding the agreement with a Mayne Pharma, see note 1.
|
| b. |
On April 1, 2025, the Company’s shareholders approved a reverse share split of all the Company’s outstanding ordinary shares at a ratio of
|
|
Year ended December 31,
|
||||||||||||
|
2022
|
2023
|
2024
|
||||||||||
|
unaudited
|
||||||||||||
|
BASIC AND DILUTED LOSS PER ORDINARY SHARE- PRO FORMA
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
|
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE- PRO FORMA
|
|
|
|
|||||||||
F-30