RedHill Biopharma Ltd F-3, filed Aug 9, 2024
RedHill Biopharma Ltd. (RDHL)
F-3
2024-08-09
View Original
Added on
October 16, 2026
As filed with the Securities and Exchange Commission on August 9, 2024
Registration No.:
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM F-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
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REDHILL BIOPHARMA LTD.
(Exact name of registrant as specified in its charter)
Not Applicable
(Translation of Registrant's name into English)
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Israel
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Not Applicable
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(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification Number)
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21 Ha'arba'a Street
Tel Aviv 6473921
Israel
+972 (3) 541-3131
(Address and telephone number of registrant’s principal executive offices)
RedHill Biopharma Inc.
8311 Brier Creek Parkway
Suite 105-161
Raleigh, NC 27617
(984) 444-7010
8311 Brier Creek Parkway
Suite 105-161
Raleigh, NC 27617
(984) 444-7010
(Name, address, and telephone number of agent for service)
Copies of all communications, including communications sent to agent for service, should be sent to:
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Perry Wildes
Goldfarb Gross Seligman & Co.
One Azrieli Center
Tel Aviv 6702100, Israel
Tel. +972 (3) 607-4444
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Rick A. Werner, Esq.
Alla Digilova, Esq.
Haynes and Boone, LLP
30 Rockefeller Plaza
New York, New York 10112 Tel. (212) 659-7300 Fax (212) 884-8234
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Approximate date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective as determined by market
conditions
If only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following
box. ☒
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number
of the earlier effective registration statement for the same offering. ☐
If this Form is a registration statement pursuant to General Instruction I.C. or a post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.C. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933.
Emerging growth company ☐
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 7(a)(2)(B) of the Securities 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.
The registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a
further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on
such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The
information contained in this preliminary prospectus is not complete and may be changed. We may not
sell
these securities until the registration statement filed with the Securities and Exchange Commission is
effective.
This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy
these
securities in any state where the offer or sale is not permitted.
Subject to
completion, dated August 9, 2024
PROSPECTUS
$50,000,000
American Depositary Shares representing Ordinary Shares
Ordinary Shares
Warrants
Subscription Rights
Units
REDHILL BIOPHARMA LTD.
We may offer to the public from time to time in one or more series or issuances American Depositary Shares (“ADSs”), ordinary shares (“Ordinary Shares”), warrants, subscription
rights and/or units consisting of two or more of these classes or series of securities. Each ADS represents four hundred (400) of our Ordinary Shares.
We refer to the ADSs, Ordinary Shares, warrants, subscription rights and units collectively as “securities” in this prospectus.
Each time we sell securities pursuant to this prospectus, we will provide a supplement to this prospectus that contains specific information about the offeror, the offering and the
specific terms of the securities offered. This prospectus may not be used to consummate a sale of securities by us unless accompanied by the applicable prospectus supplement. You should read this prospectus and the applicable prospectus supplement
carefully before you invest in our securities.
We may, from time to time, offer to sell the securities, through public or private transactions, directly or through underwriters, agents or dealers, on or off the Nasdaq Capital
Market, as applicable, at prevailing market prices or at privately negotiated prices. If any underwriters, agents or dealers are involved in the sale of any of these securities, the applicable prospectus supplement will set forth the names of the
underwriter, agent or dealer and any applicable fees, commissions or discounts.
As of August 9, 2024, the aggregate market value worldwide of our outstanding voting and non-voting common equity held by non-affiliates was approximately $24.2 million, based on
32,013,477 ADSs outstanding, of which 31,891,931 ADSs were held by non-affiliates, and a per ADS price of $0.76 based on the closing sale price of our ADSs on the Nasdaq Capital Market on August 1, 2024. Pursuant to General Instruction I.B.5 of Form
F-3, in no event will we sell, pursuant to the registration statement of which this prospectus forms a part, securities with a value exceeding one-third of the aggregate market value of our outstanding ADSs held by non-affiliates in any 12-month
period, so long as the aggregate market value of our ordinary shares held by non-affiliates is less than $75.0 million.
The ADSs are traded on the Nasdaq Capital Market (“Nasdaq”) under the symbol “RDHL.” On August 5, 2024, the last reported sale price of the ADSs was $0.46 per ADS.
We are a “foreign private issuer” under applicable Securities and Exchange Commission rules, and will be subject to reduced public company reporting requirements for this
prospectus and future filings. See “Prospectus Summary — Implications of Being a Foreign Private Issuer.”
Investing in these securities involves a high degree of risk. Please carefully consider the risks discussed in this prospectus under “Risk Factors” beginning on
page 5 and the “Risk Factors” in “Item 3: Key Information - Risk Factors” of our most recent Annual Report on Form 20-F incorporated by reference in this prospectus and in any applicable prospectus supplement for a discussion of the factors you
should consider carefully before deciding to purchase these securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of the securities being offered by this prospectus
or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2024.
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TABLE OF CONTENTS
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This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, or SEC, utilizing a “shelf” registration process. Under this process,
we may offer and sell our securities under this prospectus.
Under this shelf process, we may sell the securities described in this prospectus in one or more offerings up to a total price to the public of $50,000,000. The offer and sale of
securities under this prospectus may be made from time to time, in one or more offerings, in any manner described under the section in this prospectus entitled “Plan of Distribution.”
This prospectus provides you with a general description of the securities we may offer. Each time we sell securities we will provide a prospectus supplement that will contain
specific information about the terms of that offering. The prospectus supplement may also add, update or change information contained in this prospectus, and may also contain information about any material federal income tax considerations relating
to the securities covered by the prospectus supplement. You should read both this prospectus and any prospectus supplement together with additional information under the headings “Where You Can Find More Information” and “Incorporation of Certain
Documents by Reference.”
This summary may not contain all of the information that may be important to you. You should read this entire prospectus, including the financial statements and related notes and
other financial data incorporated by reference in this prospectus, before making an investment decision. This summary contains forward-looking statements that involve risks and uncertainties. Our actual results may differ significantly from the
results discussed in the forward-looking statements. Factors that might cause or contribute to such differences include those discussed in “Risk Factors” and “Forward-Looking Statements.”
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This summary provides an overview of selected information contained elsewhere or incorporated by reference into this prospectus and does not contain all the
information you should consider before investing in our securities. You should carefully read the prospectus, the applicable prospectus supplement and any related free writing prospectus, including the risks of investing in our securities discussed
under the heading “Risk Factors” contained in this prospectus, the applicable prospectus supplement and any related free writing prospectus, and under similar
headings in the other documents that are incorporated by reference into this prospectus, including our financial statements, and the exhibits to the registration statement of which this prospectus is a part.
REDHILL BIOPHARMA LTD.
We are a specialty biopharmaceutical company, primarily focused on GI and infectious diseases. Our primary goal is to become a leading specialty biopharmaceutical company.
We are currently focused primarily on the advancement of our development pipeline of clinical-stage therapeutic candidates. We also commercialize in the U.S. GI-related products, Talicia®
(omeprazole, amoxicillin, and rifabutin) and (until October 8, 2024) Aemcolo® and continue to explore our strategic plans for such products and activities.
Among the therapeutic candidates, we are exploring opaganib is being as a potential treatment for various conditions, including GI-ARS, COVID-19 and other viruses as part of pandemic preparedness,
such as the Ebola virus. Inflammatory conditions and solid tumors are additional areas of focus for opaganib. Furthermore, we are investigating RHB-107 (upamostat) as a potential treatment for COVID-19 and other viruses as part of pandemic
preparedness, including the Ebola virus.
Our current pipeline consists of five therapeutic candidates, most of which are in clinical development. We generate our pipeline of therapeutic candidates by identifying, validating and in-licensing
or acquiring products that are consistent with our product and corporate strategy and that have the potential to exhibit a favorable probability of therapeutic and commercial success. We have one product that we primarily developed internally which
has been approved for marketing and, to date, none of our other therapeutic candidates has generated revenues. We have out-licensed one of our commercial products, Talicia® for specific territories outside the U.S. and we plan to commercialize our
therapeutic candidates, upon approval, if any, through licensing and other commercialization arrangements with pharmaceutical companies on a global and territorial basis or independently with a dedicated commercial operations or in potential
partnership with other commercial-stage companies. We also evaluate, on a case-by-case basis, co-development, co-promotion, licensing, acquisitions and similar arrangements.
Termination of Exclusive U.S. license Agreement to Terminate U.S. License for Aemcolo®
On July 9, 2024, we announced the mutual decision with Cosmo Technologies Ltd. (“Cosmo”) to voluntary terminate our exclusive U.S. license agreement for Aemcolo®, a treatment for traveler’s diarrhea
(the “License Agreement”). The License Agreement, initially dated October 17, 2019, will be officially terminated on October 8, 2024. Per the terms of the License Agreement, we will immediately cease any commercialization of Aemcolo® upon termination
of the License Agreement, at which point all rights previously ascribed in the License Agreement to us will revert to Cosmo.
Global Termination Agreement
On July 22, 2024, we announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the “Agreement”). As a result of the
Agreement, RedHill received approximately $9.9 million in cash and gained full control over an additional $0.74 million currently held in a restricted account, leading to an increase of approximately $12.2 million in liabilities for RedHill,
reflecting assumed and settled liabilities between the parties, resulting in a net balance sheet reduction of approximately $2.3 million. In addition, the Agreement ends all existing credit ties with the Agreement parties, removes the existing lien
against Talicia® and restores control over cash collections back to RedHill.
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Nasdaq Minimum Bid Price Requirement
On March 11, 2024, we received a letter from the Listings Qualifications Department of The Nasdaq Stock Market LLC (the “Listing Qualifications Department”) indicating that for the thirty consecutive
business days prior to March 11, 2024, the bid price for the ADSs had closed below the minimum $1.00 per ADS requirement for continued listing on Nasdaq under Nasdaq Listing Rule 5450(a)(1). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we
have been provided an initial period of 180 calendar days, or until September 9, 2024, to regain compliance. The letter states that the Listing Qualifications Department staff will provide written notification that we have achieved compliance with
Nasdaq Listing Rule 5450(a)(1) if at any time before September 9, 2024, the bid price of the ADSs closes at $1.00 per ADS or more for a minimum of ten consecutive business days. In the event that we do not regain compliance with the minimum closing
bid price requirement by September 9, 2024, we may be eligible for an additional 180 calendar day period to regain compliance, provided that we meet the continued listing requirement for market value of publicly held shares and all other initial
listing standards, with the exception of the bid price requirement, and would need to provide written notice of our intention to cure the deficiency during the second compliance period. We intend to monitor the closing bid price of the ADSs and may,
if appropriate, consider implementing available options to cure the deficiency and regain compliance with the Nasdaq minimum bid price requirement within the compliance period.
Kukbo Proceedings
We continue our litigation against Kukbo Co. Ltd. (“Kukbo”), which we filed on September 2, 2022, in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result
of Kukbo’s default in delivering us an aggregate of $6.5 million under the subscription agreement, dated October 25, 2021, in exchange for the ADSs that we were to issue to Kukbo, and the exclusive license agreement with Kukbo, dated March 14, 2022.
Kukbo thereafter filed counterclaims with various allegations, such as breach of contract, misrepresentation and the breach of the duty of good faith and fair dealing. The parties have completed discovery and depositions, and both parties have filed
motions for summary judgment that are now pending before Justice Bannon. We intend to continue to rigorously pursue the Kukbo litigation. On November 20, 2023, we entered into a Contingency Fee Agreement with our legal firm, Haynes and Boone, LLP
(“H&B”), under which certain legal costs related to the Kukbo litigation will be assumed by H&B.
January 2024 Offering
On January 26, 2024, we issued to certain institutional investors (i) in a registered direct offering, 10,000,000 ADSs at a purchase price of $0.80 per ADS and (ii) in a concurrent private offering,
unregistered warrants to purchase 10,000,000 ADSs (the “January 2024 Offering”). The warrants have an exercise price of $1.00 per ADS, are exercisable immediately and will expire five years from the date of issuance.
The issuance of the warrants was exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to an exemption provided by
Section 4(a)(2) thereof and Rule 506 of Regulation D promulgated thereunder as a transaction by an issuer not involving a public offering. Pursuant to a securities purchase agreement (the “Purchase Agreement”), dated as of January 25, 2024, between
us and the purchasers named on the signature pages thereto, we agreed, among other things, to file a registration statement with the SEC as soon as practicable (and in any event within fifteen (15) calendar days of the date of the Purchase Agreement)
and to keep such registration statement effective until such time as the investors, their successors and assigns, as applicable, no longer own any warrants or the ADSs issuable upon exercise thereof.
As part of the compensation to the placement agent in connection with its role as the placement agent in the January 2024 Offering, pursuant to the engagement letter, dated as of January 24, 2024,
between us and the placement agent, we issued to the placement agent’s designees unregistered warrants to purchase up to an aggregate of 600,000 ADSs at an exercise price of $1.00 per ADS. The warrants issued to the placement agent’s designees are
exercisable immediately and will expire five years from the commencement of the sales pursuant to the January 2024 Offering.
April 2024 Offering
On March 29, 2024, we entered into a securities purchase agreement with certain investors, pursuant to which we agreed to issue and sell, in a registered direct offering directly to such investors,
(i) 2,144,487 ADSs and (ii) warrants to purchase up to an aggregate of 2,144,487 ADSs, at a combined purchase price of $0.58289 per ADS and accompanying warrant (the “April 2024 Offering”). The warrants have an exercise price of $0.75 per ADS, are
immediately exercisable upon issuance and have a term of five years following the issuance date. The April 2024 Offering closed on April 3, 2024. The gross proceeds to us were approximately $1.25 million, before deducting offering expenses payable by
us.
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Implications of Being a Foreign Private Issuer
We are subject to the information reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are applicable to “foreign private issuers,” and under those
requirements we file reports with the United States Securities and Exchange Commission, or SEC. As a foreign private issuer, we are not subject to the same requirements that are imposed upon U.S. domestic issuers by the SEC. Under the Exchange Act,
we are subject to reporting obligations that, in certain respects, are less detailed and less frequent than those of U.S. domestic reporting companies. For example, although we often report our financial results on a quarterly basis, we are not
required to issue quarterly reports, proxy statements that comply with the requirements applicable to U.S. domestic reporting companies, or individual executive compensation information that is as detailed as that required of U.S. domestic reporting
companies. We also have four months after the end of each fiscal year to file our annual reports with the SEC and are not required to file current reports as frequently or promptly as U.S. domestic reporting companies.
Furthermore, our officers, directors and principal shareholders are exempt from the requirements to report transactions in our equity securities and from the short-swing profit liability provisions
contained in Section 16 of the Exchange Act. As a foreign private issuer, we are also not subject to the requirements of Regulation FD (Fair Disclosure) promulgated under the Exchange Act. In addition, as a foreign private issuer, we are permitted,
and follow certain home country corporate governance practices instead of those otherwise required under the listing rules of Nasdaq for domestic U.S. issuers. These exemptions and leniencies reduce the frequency and scope of information and
protections available to you in comparison to those applicable to a U.S. domestic reporting company.
Corporate Information
We were incorporated as a limited liability company under the laws of the State of Israel on August 3, 2009. Our principal executive offices are located at 21
Ha’arba’a Street, Tel-Aviv, Israel and our telephone number is +972 (3) 541-3131. Our website address is http://www.redhillbio.com. The information on, or that can be accessed through, our website does not constitute part of this prospectus. Our
registered agent in the U.S. is RedHill Biopharma Inc. (“Redhill U.S.”). The address of RedHill Biopharma Inc. is 8311 Brier Creek Parkway, Suite 105-161, Raleigh, NC 27617, U.S.A.
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An investment in our securities involves a high degree of risk. Our business, financial condition or results of operations could be adversely affected by any
of these risks. You should carefully consider the risk factors discussed under the caption “Item 3: Key Information - Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, and in
any other filing we make with the SEC subsequent to the date of this prospectus, each of which is incorporated herein by reference, and in any supplement to this prospectus, before making your investment decision. The risks and uncertainties we have
described are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. Past financial performance may not be a reliable indicator of future
performance, and historical trends should not be used to anticipate results or trends in future periods. If any of these risks actually occurs, our business, business prospects, financial condition or results of operations could be seriously harmed.
This could cause the trading price of the ADSs to decline, resulting in a loss of all or part of your investment. Please also read carefully the section below entitled “Forward-Looking Statements.”
FORWARD-LOOKING STATEMENTS
This prospectus, including the information incorporated by reference into this prospectus, contains, and any prospectus supplement may include forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,”
“may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based
on assumptions and subject to risks and uncertainties. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or
revise any forward-looking statements.
Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:
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the going concern reference in our financial statements and our ability to obtain additional financing or successfully conclude a strategic business transaction;
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our ability to close a strategic business transactions, including potential divestment of certain of our assets;
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our reduced revenues, business size and scope, market share and opportunities in certain markets following the sale of our rights to Movantik®;
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estimates of our expenses, future revenues, capital requirements and our needs for additional financing;
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our ability to obtain additional financing;
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the commercialization and market acceptance of our commercial products;
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our ability to generate sufficient revenues from our commercial products, including obtaining commercial insurance and government reimbursement;
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our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials, and to complete the development of such therapeutic candidates and obtain approval for marketing
by the Food and Drug Administration (“FDA”) or other regulatory authorities;
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our reliance on third parties to satisfactorily conduct key portions of our commercial operations, including manufacturing and other supply chain functions, market analysis services, safety monitoring, regulatory reporting and sales data
analysis and the risk that those third parties may not perform such functions satisfactorily;
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our ability to maintain an appropriate sales and marketing infrastructure;
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our ability to establish and maintain corporate collaborations;
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that our current commercial products or commercial products that we may commercialize or promote in the future may be withdrawn from the market by regulatory authorities and our need to comply with continuing laws, regulations and
guidelines to maintain clearances and approvals for those products;
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our exposure to significant drug product liability claims;
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the initiation and completion of any postmarketing studies or trials;
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our ability to acquire products approved for marketing in the U.S. that achieve commercial success and to maintain our own marketing and commercialization capabilities;
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our estimates of the markets, their size, characteristics and their potential for our commercial products and therapeutic candidates and our ability to serve those markets;
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the successful commercialization of products we in-license or acquire;
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our inability to enforce claims relating to a breach of a representation and warranty by a counterparty;
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the hiring and continued employment of executives, sales personnel, and contractors;
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our receipt and timing of regulatory clarity and approvals for our commercial products and therapeutic candidates, and the timing of other regulatory filings and approvals;
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the initiation, timing, progress, and results of our research, development, manufacturing, preclinical studies, clinical trials, and other commercial efforts and therapeutic candidate development, as well as the extent and number of
additional studies that we may be required to conduct;
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our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
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our ability to develop or obtain approval for RHB-104 may be adversely impacted if a diagnostic test for MAP will not become available;
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our reliance on third parties to conduct key portions of our clinical trials, including data management services and the risk that those third parties may not perform such functions satisfactorily;
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our reliance on third parties to manufacture and supply our therapeutic candidates and their respective active pharmaceutical ingredients with the requisite quality and manufacturing standards in sufficient quantities and within the
required timeframes and at an acceptable cost;
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the research, manufacturing, clinical development, commercialization, and market acceptance of our therapeutic candidates;
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the interpretation of the properties and characteristics of our commercial products or therapeutic candidates and of the results obtained in research, preclinical studies or clinical trials;
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the implementation of our business model, strategic plans for our business, commercial products, and therapeutic candidates;
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the impact of other companies and technologies that compete with us within our industry;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our commercial products and therapeutic candidates, including from existing or future claims of infringement, and our ability to
operate our business without infringing or violating the intellectual property rights of others;
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parties from whom we license or acquire our intellectual property defaulting in their obligations toward us;
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the failure by a licensor or a partner of ours to meet their respective obligations under our acquisition, in-license or other development or commercialization agreements or renegotiate the obligations under such agreements, or if other
events occur that are not within our control, such as bankruptcy of a licensor or a partner;
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our reliance on the actions of third parties, including sublicensors and their other sublicensees, to maintain our rights under our in-licenses which are sublicenses;
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the effect of a potential occurrence of patients suffering serious adverse events using investigative drugs under our Expanded Access Program;
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our ability to implement network systems and controls that are effective at preventing cyber-attacks, malware intrusions, malicious viruses and ransomware threats;
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our ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market (“Nasdaq”);
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the impact on our business of the political and security situation in Israel, the U.S. and other places in which we operate; and
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other factors discussed in our Annual Report on Form 20-F.
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We caution you to carefully consider these risks and not to place undue reliance on our forward-looking statements. Except as required by law, we assume no responsibility for
updating any forward-looking statements.
The following table sets forth our total capitalization as of December 31, 2023:
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on an actual basis; and
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on a pro forma basis, after giving effect to (i) the January 2024 Offering, and the receipt of the net proceeds of approximately $7.1 million from the January 2024 Offering, after deducting placement agent fees and expenses payable by us,
(ii) the issuance of warrants to purchase up to 600,000 ADSs issued to the placement agent’s designees as partial compensation to the placement agent in connection with the January 2024 Offering (the “January 2024 Placement Agent Warrants”),
and (iii) the April 2024 Offering, and the receipt of the net proceeds of approximately $1.2 million from the April 2024 Offering, after deducting fees and expenses payable by us.
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The information set forth in the following table should be read in conjunction with and is qualified in its entirety by reference to the audited and unaudited financial statements and notes thereto
incorporated by reference in this prospectus.
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(In thousands, except share data)
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Actual
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Pro Forma
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Total debt (1)
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$
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20,978
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$
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29,886
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Ordinary shares, par value NIS 0.01 per share
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21,441
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34,577
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Additional paid-in capital
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388,363
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375,542
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Accumulated deficit
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407,735
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408,696
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Total shareholders’ equity
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2,069
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1,423
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Total capitalization
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$
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23,047
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$
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31,309
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Includes $19.2 million reported as current liabilities, which mainly consist of accounts payable, allowance for deductions from revenues and accrued expenses, and $1.7 million reported as non-current liabilities, which mainly consist of
derivative financial instruments and royalty obligation. The warrants granted to the investors in (i) the underwritten offering consummated in December 2022, (ii) the January 2024 Offering and (iii) the April 2024 Offering were classified as
a financial liability due to a net settlement provision. Therefore, some of the proceeds of the issuances were classified as derivative financial instruments and increased the total debt accordingly.
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The above discussion and table are based on 7,869,853,400 Ordinary Shares outstanding as of December 31, 2023. As of December 31, 2023, prior to giving effect to the January 2024 Offering, the
January 2024 Placement Agent Warrants and the April 2024 Offering, we had (i) 39,070,400 Ordinary Shares issuable upon the exercise of outstanding options to purchase Ordinary Shares at a weighted average exercise price of $0.63 per share (equivalent
to 97,676 ADSs at a weighted average exercise price of $252.98 per ADS); (ii) 508,836,400 Ordinary Shares issuable upon the exercise of outstanding warrants to purchase Ordinary Shares at a weighted average exercise price of $0.01 per share
(equivalent to 1,272,091 ADSs at a weighted average exercise price of $3.45 per ADS), and (iii) 177,703 outstanding RSUs, each RSU representing one ADS.
We completed the listing of ADSs on the Nasdaq Capital Market on December 27, 2012, and on July 20, 2018, the ADSs were listed on the Nasdaq Global Market. On November 15, 2023,
the ADSs were transferred from the Nasdaq Global Market to the Nasdaq Capital Market. The ADSs are currently traded on the Nasdaq Capital Market under the symbol “RDHL.”
OFFER STATISTICS AND EXPECTED TIMETABLE
We may sell from time to time pursuant to this prospectus (as may be detailed in an applicable prospectus supplement) an indeterminate number of securities as shall have a maximum
aggregate offering price of $50,000,000. The actual price per security of the securities that we will offer pursuant hereto will depend on a number of factors that may be relevant as of the time of offer. See “Plan of Distribution.”
USE OF PROCEEDS
Unless otherwise indicated in an accompanying prospectus supplement, the net proceeds from the sale of securities will be used for general corporate purposes, including research
and development related purposes in connection with our therapeutic candidates, for potential acquisitions and to support commercial operations.
DESCRIPTION OF ORDINARY SHARES
A description of our Ordinary Shares can be found in Exhibit 2.3 to our Annual Report on Form 20-F filed with the SEC on April 8, 2024.
DESCRIPTION OF AMERICAN DEPOSITARY SHARES
A description of the ADSs, each of which represents four hundred (400) of our Ordinary Shares, can be found in Exhibit 2.3 to our Annual Report on Form 20-F filed with the SEC on
April 8, 2024.
8
We may issue warrants to purchase ADS and/or Ordinary Shares. Warrants may be issued independently or together with any other securities and may be attached to, or separate from,
such securities. We will evidence each series of warrants by warrant certificates that we may issue under a separate agreement. We may enter into a warrant agreement with a warrant agent. We may also choose to act as our own warrant agent. We will
indicate the name and address of any such warrant agent in the applicable prospectus supplement relating to a particular series of warrants. The terms of any warrants to be issued and a description of the material provisions of the applicable warrant
agreement will be set forth in the applicable prospectus supplement.
The applicable prospectus supplement will describe the following terms of any warrants in respect of which this prospectus is being delivered:
| • |
the title of such warrants;
|
| • |
the aggregate number of such warrants;
|
| • |
the price or prices at which such warrants will be issued and exercised;
|
| • |
the currency or currencies in which the price of such warrants will be payable;
|
| • |
the securities purchasable upon exercise of such warrants;
|
| • |
the date on which the right to exercise such warrants shall commence and the date on which such right shall expire;
|
| • |
if applicable, the minimum or maximum amount of such warrants which may be exercised at any one time;
|
| • |
if applicable, the designation and terms of the securities with which such warrants are issued and the number of such warrants issued with each such security;
|
| • |
if applicable, the date on and after which such warrants and the related securities will be separately transferable;
|
| • |
information with respect to book-entry procedures, if any;
|
| • |
any material Israeli and United States federal income tax consequences;
|
| • |
the anti-dilution provisions of the warrants, if any; and
|
| • |
any other terms of such warrants, including terms, procedures and limitations relating to the exchange and exercise of such warrants.
|
Amendments and Supplements to Warrant Agreement
We and the warrant agent may amend or supplement the warrant agreement for a series of warrants without the consent of the holders of the warrants issued thereunder to effect
changes that are not inconsistent with the provisions of the warrants and that do not materially and adversely affect the interests of the holders of the warrants.
We may issue subscription rights to purchase our Ordinary Shares and/or ADSs. These subscription rights may be issued independently or together with any other security offered
hereby and may or may not be transferable by the shareholder receiving the subscription rights in such offering. In connection with any offering of subscription rights, we may enter into a standby arrangement with one or more underwriters or other
purchasers pursuant to which the underwriters or other purchasers may be required to purchase any securities remaining unsubscribed for after such offering.
The prospectus supplement relating to any subscription rights we offer, if any, will, to the extent applicable, include specific terms relating to the offering, including some or
all of the following:
| • |
the price, if any, for the subscription rights;
|
| • |
the exercise price payable for each ordinary share and/or ADS upon the exercise of the subscription rights;
|
| • |
the number of subscription rights to be issued to each shareholder;
|
| • |
the number and terms of the Ordinary Shares and/or ADSs which may be purchased per each subscription right;
|
| • |
the extent to which the subscription rights are transferable;
|
| • |
any other terms of the subscription rights, including the terms, procedures and limitations relating to the exchange and exercise of the subscription rights;
|
| • |
the date on which the right to exercise the subscription rights shall commence, and the date on which the subscription rights shall expire;
|
| • |
the extent to which the subscription rights may include an over-subscription privilege with respect to unsubscribed securities; and
|
| • |
if applicable, the material terms of any standby underwriting or purchase arrangement which may be entered into by us in connection with the offering of subscription rights.
|
The description in the applicable prospectus supplement of any subscription rights we offer will not necessarily be complete and will be qualified in its entirety by reference to
the applicable subscription right agreement, which will be filed with the SEC if we offer subscription rights. For more information on how you can obtain copies of the applicable subscription right agreement if we offer subscription rights, see
“Where You Can Find More Information” and “Incorporation of Certain Documents by Reference” each beginning on page 14. We urge you to read the applicable subscription right agreement and any applicable prospectus supplement in their entirety.
9
We may issue units comprised of one or more of the other securities that may be offered under this prospectus, in any combination. Each unit will be issued so that the holder of
the unit is also the holder of each security included in the unit. Thus, the holder of a unit will have the rights and obligations of a holder of each included security. The unit agreement under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately at any time, or at any time before a specified date.
The prospectus supplement relating to any units we offer, if any, will, to the extent applicable, include specific terms relating to the offering, including some or all of the
following:
| • |
the material terms of the units and of the securities comprising the units, including whether and under what circumstances those securities may be held or transferred separately;
|
| • |
any material provisions relating to the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; and
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| • |
any material provisions of the governing unit agreement that differ from those described above.
|
The description in the applicable prospectus supplement of any units we offer will not necessarily be complete and will be qualified in its entirety by reference to the applicable
unit agreement, which will be filed with the SEC if we offer units. For more information on how you can obtain copies of the applicable unit agreement if we offer units, see “Where You Can Find More Information” and “Incorporation of Certain
Documents by Reference” each beginning on page 14. We urge you to read the applicable unit agreement and any applicable prospectus supplement in their entirety.
TAXATION
The material Israeli and U.S. federal income tax consequences relating to the purchase, ownership and disposition of any of the securities offered by this prospectus will be set
forth in the prospectus supplement offering those securities.
PLAN OF DISTRIBUTION
The securities being offered by this prospectus may be sold:
| • |
through agents;
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| • |
to or through one or more underwriters on a firm commitment or agency basis;
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| • |
through put or call option transactions relating to the securities;
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| • |
in at the market offerings into an existing trading market in accordance with Rule 415(a)(4) of the Securities Act;
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| • |
through broker-dealers;
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| • |
directly to purchasers, through a specific bidding or auction process, on a negotiated basis or otherwise;
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| • |
through any other method permitted pursuant to applicable law; or
|
| • |
through a combination of any such methods of sale.
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10
At any time a particular offer of the securities covered by this prospectus is made, a revised prospectus or prospectus supplement, if required, will be distributed which will set
forth the aggregate amount of securities covered by this prospectus being offered and the terms of the offering, including the name or names of any underwriters, dealers, brokers or agents, any discounts, commissions, concessions and other items
constituting compensation from us and any discounts, commissions or concessions allowed or reallowed or paid to dealers. Such prospectus supplement, and, if necessary, a post-effective amendment to the registration statement of which this prospectus
is a part, will be filed with the SEC to reflect the disclosure of additional information with respect to the distribution of the securities covered by this prospectus. In order to comply with the securities laws of certain states, if applicable, the
securities sold under this prospectus may only be sold through registered or licensed broker-dealers. In addition, in some states the securities may not be sold unless they have been registered or qualified for sale in the applicable state or an
exemption from registration or qualification requirements is available and is complied with.
The distribution of securities may be effected from time to time in one or more transactions, including block transactions and transactions on the Nasdaq Capital Market or any
other organized market where the securities may be traded. The securities may be sold at a fixed price or prices, which may be changed, or at market prices prevailing at the time of sale, at prices relating to the prevailing market prices or at
negotiated prices. The consideration may be cash, or another form negotiated by the parties. Agents, underwriters or broker-dealers may be paid compensation for offering and selling the securities. That compensation may be in the form of discounts,
concessions or commissions to be received from us or from the purchasers of the securities. Any dealers and agents participating in the distribution of the securities may be deemed to be underwriters, and compensation received by them on resale of
the securities may be deemed to be underwriting discounts. If any such dealers or agents were deemed to be underwriters, they may be subject to statutory liabilities under the Securities Act.
Agents may from time to time solicit offers to purchase the securities. If required, we will name in the applicable prospectus supplement any agent involved in the offer or sale of
the securities and set forth any compensation payable to the agent. Unless otherwise indicated in the prospectus supplement, any agent will be acting on a best efforts basis for the period of its appointment. Any agent selling the securities covered
by this prospectus may be deemed to be an underwriter, as that term is defined in the Securities Act, of the securities.
If underwriters are used in a sale, securities will be acquired by the underwriters for their own account and may be resold from time to time in one or more transactions, including
negotiated transactions, at a fixed public offering price or at varying prices determined at the time of sale, or under delayed delivery contracts or other contractual commitments. Securities may be offered to the public either through underwriting
syndicates represented by one or more managing underwriters or directly by one or more firms acting as underwriters. If an underwriter or underwriters are used in the sale of securities, an underwriting agreement will be executed with the underwriter
or underwriters, as well as any other underwriter or underwriters, with respect to a particular underwritten offering of securities, and will set forth the terms of the transactions, including compensation of the underwriters and dealers and the
public offering price, if applicable. The prospectus and prospectus supplement will be used by the underwriters to resell the securities.
If a dealer is used in the sale of the securities, we or an underwriter will sell the securities to the dealer, as principal. The dealer may then resell the securities to the
public at varying prices to be determined by the dealer at the time of resale. To the extent required, we will set forth in the prospectus supplement the name of the dealer and the terms of the transactions.
We may directly solicit offers to purchase the securities and may make sales of securities directly to institutional investors or others. These persons may be deemed to be
underwriters within the meaning of the Securities Act with respect to any resale of the securities. To the extent required, the prospectus supplement will describe the terms of any such sales, including the terms of any bidding or auction process, if
used.
11
Agents, underwriters and dealers may be entitled under agreements which may be entered into with us to indemnification by us against specified liabilities, including liabilities
incurred under the Securities Act, or to contribution by us to payments they may be required to make in respect of such liabilities. If required, the prospectus supplement will describe the terms and conditions of the indemnification or contribution.
Some of the agents, underwriters or dealers, or their affiliates may be customers of, engage in transactions with or perform services for us or our subsidiaries.
Any person participating in the distribution of securities registered under the registration statement that includes this prospectus will be subject to applicable provisions of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the applicable SEC rules and regulations, including, among others, Regulation M, which may limit the timing of purchases and sales of any of our securities by that person.
Furthermore, Regulation M may restrict the ability of any person engaged in the distribution of our securities to engage in market-making activities with respect to our securities. These restrictions may affect the marketability of our securities and
the ability of any person or entity to engage in market-making activities with respect to our securities.
Certain persons participating in an offering may engage in over-allotment, stabilizing transactions, short-covering transactions, penalty bids and other transactions that
stabilize, maintain or otherwise affect the price of the offered securities. These activities may maintain the price of the offered securities at levels above those that might otherwise prevail in the open market, including by entering stabilizing
bids, effecting syndicate covering transactions or imposing penalty bids, each of which is described below.
| • |
A stabilizing bid means the placing of any bid, or the effecting of any purchase, for the purpose of pegging, fixing or maintaining the price of a security.
|
| • |
A syndicate covering transaction means the placing of any bid on behalf of the underwriting syndicate or the effecting of any purchase to reduce a short position created in connection with the offering.
|
| • |
A penalty bid means an arrangement that permits the managing underwriter to reclaim a selling concession from a syndicate member in connection with the offering when offered securities originally sold by the syndicate member are purchased
in syndicate covering transactions.
|
These transactions may be effected on an exchange or automated quotation system, if the securities are listed on that exchange or admitted for trading on that automated quotation
system, or in the over-the-counter market or otherwise.
If so indicated in the applicable prospectus supplement, we will authorize agents, underwriters or dealers to solicit offers from certain types of institutions to purchase offered
securities from us at the public offering price set forth in such prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future. Such contracts will be subject only to those
conditions set forth in the prospectus supplement and the prospectus supplement will set forth the commission payable for solicitation of such contracts.
In addition, Ordinary Shares or ADSs may be issued upon conversion of or in exchange for debt securities or other securities.
Any underwriters to whom offered securities are sold for public offering and sale may make a market in such offered securities, but such underwriters will not be obligated to do so
and may discontinue any market making at any time without notice. The offered securities may or may not be listed on a national securities exchange. No assurance can be given that there will be a market for the offered securities.
Any securities that qualify for sale pursuant to Rule 144 or Regulation S under the Securities Act, may be sold under Rule 144 or Regulation S rather than pursuant to this
prospectus.
To the extent that we make sales to or through one or more underwriters or agents in at-the-market offerings, we will do so pursuant to the terms of a distribution agreement
between us and the underwriters or agents. If we engage in at-the-market sales pursuant to a distribution agreement, we will sell our Ordinary Shares or ADSs to or through one or more underwriters or agents, which may act on an agency basis or on a
principal basis. During the term of any such agreement, we may sell Ordinary Shares or ADSs on a daily basis in exchange transactions or otherwise as we agree with the underwriters or agents. The distribution agreement will provide that any Ordinary
Shares or ADSs sold will be sold at prices related to the then prevailing market prices for our Ordinary Shares or ADSs. Therefore, exact figures regarding proceeds that will be raised or commissions to be paid cannot be determined at this time and
will be described in a prospectus supplement. Pursuant to the terms of the distribution agreement, we also may agree to sell, and the relevant underwriters or agents may agree to solicit offers to purchase, blocks of our Ordinary Shares, ADSs or
warrants. The terms of each such distribution agreement will be set forth in more detail in a prospectus supplement to this prospectus.
12
In connection with offerings made through underwriters or agents, we may enter into agreements with such underwriters or agents pursuant to which we receive our outstanding
securities in consideration for the securities being offered to the public for cash. In connection with these arrangements, the underwriters or agents may also sell securities covered by this prospectus to hedge their positions in these outstanding
securities, including in short sale transactions. If so, the underwriters or agents may use the securities received from us under these arrangements to close out any related open borrowings of securities.
We may enter into derivative transactions with third parties or sell securities not covered by this prospectus to third parties in privately negotiated transactions. If the
applicable prospectus supplement indicates, in connection with those derivatives, such third parties (or affiliates of such third parties) may sell securities covered by this prospectus and the applicable prospectus supplement, including in short
sale transactions. If so, such third parties (or affiliates of such third parties) may use securities pledged by us or borrowed from us or others to settle those sales or to close out any related open borrowings of shares, and may use securities
received from us in settlement of those derivatives to close out any related open borrowings of shares. The third parties (or affiliates of such third parties) in such sale transactions will be underwriters and, if not identified in this prospectus,
will be identified in the applicable prospectus supplement (or a post-effective amendment).
We may loan or pledge securities to a financial institution or other third party that in turn may sell the securities using this prospectus. Such financial institution or third
party may transfer its short position to investors in our securities or in connection with a simultaneous offering of other securities offered by this prospectus or in connection with a simultaneous offering of other securities offered by this
prospectus.
Certain legal matters with respect to Israeli law and with respect to the validity of the offered securities under Israeli law will be passed upon for us by Goldfarb Gross Seligman
& Co. Certain legal matters with respect to U.S. federal securities law and New York law will be passed upon for us by Haynes and Boone, LLP.
EXPERTS
The financial statements and management’s assessment of the effectiveness of internal control over financial reporting (which is included in Management’s Report on Internal Control
over Financial Reporting) incorporated in this Prospectus by reference to the Annual Report on Form 20-F for the year ended December 31, 2023, have been so incorporated in reliance on the report of Kesselman & Kesselman, Certified Public
Accountants (Isr.) (which contains an adverse opinion on the effectiveness of the Company’s internal control over financial reporting and includes an explanatory paragraph regarding the existence of substantial doubt about the Company’s ability to
continue as a going concern as described in Note 1a(3) to the financial statements), a member firm of PricewaterhouseCoopers International Limited, an independent registered public accounting firm, given on the authority of said firm as experts in
auditing and accounting.
13
We have filed with the SEC a registration statement on Form F-3 under the Securities Act, with respect to the securities offered by this prospectus. However, as is permitted by the
rules and regulations of the SEC, this prospectus, which is part of our registration statement on Form F-3, omits certain non-material information, exhibits, schedules and undertakings set forth in the registration statement. For further information
about us, and the securities offered by this prospectus, please refer to the registration statement.
We are subject to the reporting requirements of the Exchange Act that are applicable to a foreign private issuer. In accordance with the Exchange Act, we file reports, including
annual reports on Form 20-F by April 30 of each year. We also furnish to the SEC under cover of Form 6-K material information required to be made public in Israel, filed with and made public by any stock exchange or distributed by us to our
shareholders.
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers, such as us, that file electronically with the
SEC (http://www.sec.gov). These SEC filings are also available to the public from commercial document retrieval services.
As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements to shareholders and our officers,
directors and principal shareholders are exempt from the “short-swing profits” reporting and liability provisions contained in Section 16 of the Exchange Act and related Exchange Act rules.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
We file annual and special reports and other information with the SEC. These filings contain important information which does not appear in this prospectus. The SEC allows us to
“incorporate by reference” information into this prospectus, which means that we can disclose important information to you by referring you to other documents which we have filed or will file with the SEC. We are incorporating by reference in this
prospectus the documents listed below and all amendments or supplements we may file to such documents, as well as any future filings we may make with the SEC on Form 20-F under the Exchange Act before the time that all of the securities offered by
this prospectus have been sold or de-registered:
| • |
the description of our ADSs and our Ordinary Shares contained in Exhibit 2.3 to our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, filed with the SEC on April 8, 2024;
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our Annual Report on Form 20-F for the fiscal year ended December 31, 2023, filed with the SEC on April 8, 2024; and
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| • |
reports on Form 6-K filed on April 24, 2024, May 6, 2024, June 3,
2024, June 6, 2024, July 9, 2024, July 22,
2024, August 1, 2024 and August 6, 2024 (in each case only to the extent provided in such Form 6-K).
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In addition, any reports on Form 6-K we submit to the SEC pursuant to the Exchange Act after the date of the initial registration statement and prior to effectiveness of the
registration statement that we specifically identify in such forms as being incorporated by reference into the registration statement of which this prospectus forms a part, all subsequent annual reports on Form 20-F filed after the effective date of
this registration statement and prior to the termination of this offering, and any reports on Form 6-K subsequently submitted to the SEC or portions thereof that we specifically identify in such forms as being incorporated by reference into the
registration statement of which this prospectus forms a part, shall be considered to be incorporated into this prospectus by reference and shall be considered a part of this prospectus from the date of filing or submission of such documents.
Certain statements in and portions of this prospectus update and replace information in the above-listed documents incorporated by reference. Likewise, statements in or portions of
a future document incorporated by reference in this prospectus may update and replace statements in and portions of this prospectus or the above-listed documents.
We will provide you without charge, upon your written or oral request, a copy of any of the documents incorporated by reference in this prospectus, other than exhibits to such
documents which are not specifically incorporated by reference into such documents. Please direct your written or telephone requests to RedHill Biopharma Ltd., 21 Ha’arba’a Street, Tel Aviv 6473921, Israel, Attn: Dror Ben-Asher, telephone number:
+972 (3) 541-3131. You may also obtain information about us by visiting our website at www.redhillbio.com. Information contained in our website is included as an inactive textual reference only and is not part
of this prospectus. The SEC maintains an Internet site, http://www.sec.gov, that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC.
14
We are incorporated under the laws of the State of Israel. Service of process upon us and upon our directors and officers and the Israeli experts named in this prospectus, many of
whom reside outside the United States, may be difficult to obtain within the United States. Furthermore, because many of our assets and most of our directors and officers are located outside the United States, any judgment obtained in the United
States against us or any of our directors and officers may not be collectible within the United States.
It may be difficult to assert U.S. securities law claims in original actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities
laws because Israel is not the most appropriate forum to bring such a claim. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is applicable to the claim. If U.S. law is found to be
applicable, the content of applicable U.S. law must be proved as a fact which can be a time-consuming and costly process. Certain matters of the procedure will also be governed by Israeli law.
Subject to specified time limitations and legal procedures, Israeli courts may enforce a United States judgment in a civil matter which, subject to certain exceptions, is
non-appealable, including judgments based upon the civil liability provisions of the Securities Act and the Exchange Act and including a monetary or compensatory judgment in a non-civil matter, provided that:
| • |
the judgments are obtained after due process before a court of competent jurisdiction, according to the laws of the state in which the judgment is given and the rules of private international law currently prevailing in Israel;
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the prevailing law of the foreign state in which the judgments were rendered allows the enforcement of judgments of Israeli courts (however, the Israeli courts may waive this requirement following a request by the attorney general);
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adequate service of process has been effected and the defendant has had a reasonable opportunity to be heard and to present his or her evidence;
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| • |
the judgments are not contrary to public policy, and the enforcement of the civil liabilities set forth in the judgment does not impair the security or sovereignty of the State of Israel;
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the judgments were not obtained by fraud and do not conflict with any other valid judgment in the same matter between the same parties;
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an action between the same parties in the same matter is not pending in any Israeli court at the time the lawsuit is instituted in the foreign court; and
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the obligations under the judgment are enforceable according to the laws of the State of Israel and according to the law of the foreign state in which the relief was granted.
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We have irrevocably appointed RedHill Biopharma Inc. as our agent to receive service of process in any action against us in any United States federal or state court arising out of
this offering or any purchase or sale of securities in connection with this offering.
If a foreign judgment is enforced by an Israeli court, it generally will be payable in Israeli currency, which can then be converted into non-Israeli currency and transferred out
of Israel. The usual practice in an action before an Israeli court to recover an amount in a non-Israeli currency is for the Israeli court to issue a judgment for the equivalent amount in Israeli currency at the rate of exchange in force on the date
of the judgment, but the judgment debtor may make payment in foreign currency. Pending collection, the amount of the judgment of an Israeli court stated in Israeli currency ordinarily will be linked to the Israeli consumer price index plus interest
at the annual statutory rate set by Israeli regulations prevailing at the time. Judgment creditors must bear the risk of unfavorable exchange rates.
15
The following table sets forth the expenses (other than underwriting discounts and commissions or agency fees and other items constituting underwriters’ or agents’ compensation, if
any) expected to be incurred by us in connection with a possible offering of securities registered under this registration statement.
|
SEC registration fees
|
$
|
0
|
(1)
|
|
|
FINRA fees
|
$
|
500
|
(2)
|
|
|
Legal fees and expenses
|
$
|
*
|
||
|
Accountants’ fees and expenses
|
$
|
*
|
||
|
Miscellaneous
|
$
|
*
|
||
|
|
||||
|
Total
|
$
|
*
|
___________________
(1) We previously registered securities in the aggregate offering price of $200,000,000 pursuant to the Registration Statement on Form F-3 (File No. 333-258259) filed with the
SEC on July 29, 2021 (the “Prior Registration Statement”). As of the date of this registration statement, we have sold $42,571,278 worth of securities under the Prior Registration Statement, leaving a balance of $157,428,722 of unsold securities
under the Prior Registration Statement (the “Unsold Securities”). We expect to carry forward to this registration statement $50,000,000 of the Unsold Securities (the “Carry Forward Securities”) pursuant to Rule 415(a)(6) under the Securities Act of
1933, as amended. The $7,380 previously paid filing fee relating to such Carry Forward Securities under the Prior Registration Statement will continue to be applied to such Carry Forward Securities registered on this registration statement. For
reasons stated above, the net SEC registration fee due is $0. To the extent that, after the filing date hereof and prior to the effectiveness of this registration statement, we sell any Unsold Securities pursuant to the Prior Registration Statement,
we will identify in a pre-effective amendment to this registration statement the updated amount of Unsold Securities from the Prior Registration Statement to be included in this registration statement pursuant to Rule 415(a)(6). Pursuant to Rule
415(a)(6), the offering of the Unsold Securities under the Prior Registration Statement will be deemed terminated as of the date of effectiveness of this registration statement.
(2) The FINRA Fee is equal to the sum of 0.015% of the proposed maximum aggregate offering amount plus $500.00. Because all securities are being carried forward from the Prior
Registration Statement and the Company paid the FINRA Fee in connection with the Prior Registration Statement, the proposed maximum aggregate offering amount is treated as $0.
* These fees are calculated based on the securities offered and the number of issuances and accordingly cannot be estimated at this time.
16
$50,000,000
American Depositary Shares representing Ordinary Shares
Ordinary Shares
Warrants
Subscription Rights
Units
REDHILL BIOPHARMA LTD.
The date of this prospectus is , 2024.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 8. Indemnification of Directors and Officers
Exemption, Insurance and Indemnification of Directors and Officers
Exemption of Officers and Directors
Under the Israeli Companies Law, a company may not exempt an officer or director from liability with respect to a breach of his duty of loyalty but may exempt in advance an officer
or director from liability to the company, in whole or in part, with respect to a breach of his duty of care, except in connection with a prohibited distribution made by the company, if so provided in its articles of association. Our articles of
association provide for this exemption from liability for our directors and officers.
Directors’ and Officers’ Insurance
The Israeli Companies Law and our articles of association provide that, subject to the provisions of the Israeli Companies Law, we may obtain insurance for our directors and officers for any
liability stemming from any act performed by an officer or director in his capacity as an officer or director, as the case may be with respect to any of the following:
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•
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a breach of such officer’s or director’s duty of care to us or to another person;
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•
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a breach of such officer’s or director’s duty of loyalty to us, provided that such officer or director acted in good faith and had reasonable cause to assume that his act would not prejudice
our interests;
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•
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a financial liability imposed upon such officer or director in favor of another person;
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•
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financial liability imposed on the officer or director for payment to persons or entities harmed as a result of violations in administrative proceedings as described in Section
52(54)(a)(1)(a) of the Israeli Securities Law (“Party Harmed by the Breach”);
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•
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expenses incurred by such officer or director in connection with an administrative proceeding conducted in this matter, including reasonable litigation expenses, including legal fees; or
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•
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a breach of any duty or any other obligation, to the extent insurance may be permitted by law.
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Pursuant to the Compensation Policy, we may obtain a directors’ and officers’ liability insurance policy, which would apply to our or our subsidiaries’ directors and officers, as they may be, from
time to time, subject to the following terms and conditions: (a) the total insurance coverage under the insurance policy may not exceed $100 million; and (b) the purchase of such policy shall be approved by the Compensation Committee (and, if
required by law, by the Board of Directors) which shall determine that such policy reflects the current market conditions, and it shall not materially affect the Company's profitability, assets or liabilities. In addition, pursuant to our
Compensation Policy, should we sell our operations (in whole or in part) or in case of merger, spin-off or any other significant business combination involving us or part or all of our assets, we may obtain a director’s and officers’ liability
insurance policy (run-off) for our directors and officers in office with regard to the relevant operations, subject to the following terms and conditions: (a) the insurance term may not exceed seven years; (b) the coverage amount may not exceed $100
million; and (c) the purchase of such policy shall be approved by the Compensation Committee (and, if required by law, by the Board of Directors) which shall determine that such policy reflects the current market conditions, and it shall not
materially affect the Company’s profitability, assets or liabilities. The Compensation Policy is in effect for three years from the 2022 annual general meeting.
Pursuant to the foregoing approvals, we carry directors’ and officers’ liability insurance. This insurance is renewed on an annual basis.
II - 1
Indemnification of Officers and Directors
The Israeli Companies Law provides that a company may indemnify an officer or director for payments or expenses associated with acts performed in his capacity as an officer or
director of the company, provided the company’s articles of association include the following provisions with respect to indemnification:
| • |
a provision authorizing the company to indemnify an officer or director for future events with respect to a monetary liability imposed on him in favor of another person pursuant to a judgment (including a judgment given in a settlement or
an arbitrator’s award approved by the court), so long as such indemnification is limited to types of events which, in the board of directors’ opinion, are foreseeable at the time of granting the indemnity undertaking given the company’s
actual business, and in such amount or standard as the board of directors deems reasonable under the circumstances. Such undertaking must specify the events that, in the board of directors’ opinion, are foreseeable in view of the company’s
actual business at the time of the undertaking and the amount or the standards that the board of directors deemed reasonable at the time;
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| • |
a provision authorizing the company to indemnify an officer or director for future events with respect to reasonable litigation expenses, including counsel fees, incurred by an officer or director in which he is ordered to pay by a court,
in proceedings that the company institutes against him or instituted on behalf of the company or by another person, or in a criminal charge from which he was acquitted, or a criminal charge in which he was convicted for a criminal offense
that does not require proof of criminal intent;
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a provision authorizing the company to indemnify an officer or director for future events with respect to reasonable litigation fees, including attorney’s fees, incurred by an officer or director due to an investigation or proceeding filed
against him by an authority that is authorized to conduct such investigation or proceeding, and that resulted without filing an indictment against him and without imposing on him financial obligation in lieu of a criminal proceeding, or that
resulted without filing an indictment against him but with imposing on him a financial obligation as an alternative to a criminal proceeding in respect of an offense that does not require the proof of criminal intent or in connection with a
monetary sanction;
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a provision authorizing the company to indemnify an officer or director for future events with respect to a Party Harmed by the Breach;
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a provision authorizing the company to indemnify an officer or director for future events with respect to expenses incurred by such officer or director in connection with an administrative proceeding, including reasonable litigation
expenses, including legal fees; and
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a provision authorizing the company to indemnify an officer or director retroactively.
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Limitations on Insurance, Exemption and Indemnification
The Israeli Companies Law and our articles of association provide that a company may not exempt or indemnify an office holder nor enter into an insurance contract, which would
provide coverage for any monetary liability incurred as a result of any of the following:
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a breach by the officer or director of his duty of loyalty, except for insurance and indemnification where the officer or director acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;
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a breach by the officer or director of his duty of care if the breach was done intentionally or recklessly, except if the breach was solely as a result of negligence;
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any act or omission done with the intent to derive an illegal personal benefit; or
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any fine, civil fine, monetary sanctions, or forfeit imposed on the officer or director.
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In addition, under the Israeli Companies Law, exemption of, indemnification of, and procurement of insurance coverage for, our directors and officers must be approved by our audit
committee and board of directors and, in specified circumstances, by our shareholders.
II - 2
Letters of Indemnification
We may provide a commitment to indemnify in advance any director or officer of ours in the course of such person’s position as our director or officer, all subject to the letter of
indemnification, as approved by our shareholders from time to time and in accordance with our articles of association. We may provide retroactive indemnification to any officer to the extent allowed by the Israeli Companies Law. As approved by our
shareholders on May 13, 2022, the amount of the advance indemnity is limited to the higher of 25% of our then shareholders’ equity, per our most recent annual financial statements, or $10 million.
As part of the indemnification letters, we exempted our directors and officers, in advance, to the extent permitted by law, from any liability for any damage incurred by them,
either directly or indirectly, due to the breach of an officer’s or director’s duty of care vis-à-vis us, within his acts in his capacity as an officer or director. The letter provides that so long as not permitted by law, we do not exempt an officer
or director in advance from his liability to us for a breach of the duty of care upon distribution, to the extent applicable to the officer or director, if any. The letter also exempts an officer or director from any liability for any damage incurred
by him, either directly or indirectly, due to the breach of the officer or director’s duty of care vis-à-vis us, by his acts in his capacity as an officer or director prior to the letter of exemption and indemnification becoming effective.
Item 9. Exhibits
The index to exhibits appears below on the page immediately following the signature pages of this Registration Statement.
Item 10. Undertakings
(1) The undersigned registrant hereby undertakes:
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(a)
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to file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:
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(i)
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to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, or the Securities Act;
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(ii)
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to reflect in the prospectus any facts or events arising after the effective date of this Registration Statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in this Registration Statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;
and
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(iii)
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to include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in this
Registration Statement;
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provided, however, that paragraphs (i), (ii) and (iii) above do not apply if the information required to be included in a post-effective amendment by those
paragraphs is contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, or the Exchange Act that are incorporated by reference in this
Registration Statement or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the Registration Statement.
II - 3
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(b)
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that, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities
offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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(c)
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to remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
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(d)
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to file a post-effective amendment to the registration statement to include any financial statements required by Item 8.A. of Form 20-F at the start of any delayed offering or throughout a
continuous offering. Financial statements and information otherwise required by Section 10(a)(3) of the Act need not be furnished, provided that the registrant includes in the prospectus, by means of a post-effective amendment, financial
statements required pursuant to this paragraph (a)(4) and other information necessary to ensure that all other information in the prospectus is at least as current as the date of those financial statements. Notwithstanding the foregoing, with
respect to registration statements on Form F-3, a post-effective amendment need not be filed to include financial statements and information required by Section 10(a)(3) of the Act or Item 8.A of Form 20-F if such financial statements and
information are contained in periodic reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the Form F-3.
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(e)
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that, for the purpose of determining any liability under the Securities Act to any purchaser:
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(i)
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each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be a part of the registration statement as of the date the filed prospectus was deemed part of and
included in the registration statement; and
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(ii)
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each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule
415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of
prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that
date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which the prospectus relates, and the offering of such securities at that time
shall be deemed to be the initial bona fide offering thereof; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed
incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that
was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.
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(f)
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that, for the purpose of determining liability of a registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes
that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
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(i)
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any preliminary prospectus or prospectus of the undersigned registrant to the offering required to be filed pursuant to Rule 424;
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(ii)
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any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by an undersigned registrant;
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(iii)
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the portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the
undersigned registrant; and
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(iv)
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any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
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II - 4
(2) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant to Section 13(a) or
Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in this Registration Statement shall be deemed to be a
new registration statement relating to the securities offered herein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the provisions referred
to in Item 8, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event
that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or
proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a
court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
(4) The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this
Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the
time it was declared effective.
(5) The undersigned registrant hereby undertakes that, for the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be
deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
II - 5
EXHIBIT INDEX
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Exhibit No.
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Document
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1.1*
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Form of Underwriting Agreement.
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4.3*
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Form of Warrant Agreement (including form of Warrant Certificate).
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4.4*
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Form of Subscription Right Agreement (including form of Right Certificate).
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4.5*
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Form of Unit Agreement (including form of Unit Certificate).
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_______________
* To be filed, if applicable, by amendment, or as an exhibit to a report on Form 6-K and incorporated herein by reference.
# Filed herewith.
II - 6
SIGNATURES
Pursuant to the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it complies with all of the requirements for filing on
Form F-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Tel Aviv, Israel on August 9, 2024.
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By: /s/ Dror Ben-Asher
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Name: Dror Ben-Asher
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Title: Chief Executive Officer and Chairman of the Board of Directors
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KNOW ALL PERSONS BY THESE PRESENTS, each director and officer whose signature appears below constitutes and appoints, Dror Ben-Asher or Razi Ingber, or either of these, his true
and lawful attorney-in-fact and agent, with full power of substitution and re-substitution, to sign in any and all capacities any and all amendments or post-effective amendments to this registration statement on Form F-3, and to sign any and all
additional registration statements relating to the same offering of securities of the Registration Statement that are filed pursuant to Rule 462(b) of the Securities Act, and to file the same with all exhibits thereto and other documents in
connection therewith with the Securities and Exchange Commission, granting such attorney-in-fact and agent full power and authority to do all such other acts and execute all such other documents as he may deem necessary or desirable in connection
with the foregoing, as fully as the undersigned may or could do in person, hereby ratifying and confirming all that such attorney-in-fact and agent may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this registration statement has been signed below by the following persons on the dates and in the capacities indicated.
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Signature
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Title
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Date
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/s/ Dror Ben-Asher
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Chief Executive Officer and Chairman of the Board of Directors
(Principal Executive Officer)
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August 9, 2024
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Dror Ben-Asher
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/s/ Razi Ingber
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Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
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August 9, 2024
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Razi Ingber
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/s/ Eric Swenden
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Director
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August 9, 2024
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Eric Swenden
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/s/ Dr. Shmuel Cabilly
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Director
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August 9, 2024
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Dr. Shmuel Cabilly
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/s/ Dr. Kenneth Reed
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Director
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August 9, 2024
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Dr. Kenneth Reed
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/s/ Ofer Tsimchi
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Director
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August 9, 2024
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Ofer Tsimchi
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/s/ Rick Scruggs
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Chief Commercial Officer and Director
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August 9, 2024
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Rick Scruggs
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II - 7
Signature of authorized representative in the United States
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant’s duly authorized representative has signed this Registration Statement on Form F-3 on this 9th day of August,
2024.
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REDHILL BIOPHARMA INC.
Authorized U.S. Representative
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By: /s/ Razi Ingber
Name: Razi Ingber
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II - 8
Exhibit 5.1
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Tel Aviv, August 9, 2024
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RedHill Biopharma Ltd.
21 Ha’arba’a Street
Tel Aviv, 6473921
Israel
Re: RedHill Biopharma Ltd.
Ladies and Gentlemen:
We have acted as Israeli counsel for RedHill Biopharma Ltd., an Israeli company organized under the laws of the State of Israel (the “Company”), in connection with the
registration statement on Form F-3 (the “Registration Statement”) to be filed with the Securities and Exchange Commission (the “SEC”) on or about August 9, 2024 under the Securities Act of 1933, as amended (the “Act”). The
Registration Statement relates to the proposed offer and sale by the Company from time to time, as set forth in the prospectus contained in the Registration Statement (the “Prospectus”) and as shall be set forth in one or more supplements to
the Prospectus (each, a “Prospectus Supplement”), of up to a $50,000,000 aggregate amount of any of all the following securities (the “Securities”): (i) American Depositary Shares (“ADSs”) representing ordinary shares, par value
NIS 0.01 per share, of the Company (“Ordinary Shares”), (ii) Ordinary Shares, (iii) warrants to purchase Ordinary Shares and/or ADSs (“Warrants”), (iv) subscription rights (“Subscription Rights”) to purchase Ordinary Shares
and/or ADSs and/or (v) units comprised of one or more of the securities that are offered under the Prospectus (“Units”).
The Warrants will be issued under a warrant agreement (the “Warrant Agreement”) between the Company and a warrant agent (the “Warrant Agent”). The Subscription
Rights will be issued under a subscription rights agreement (the “Subscription Rights Agreement”) between the Company and a rights agent (the “Rights Agent”). The Units will be issued under a unit agreement (the “Unit Agreement”)
between the Company and a unit agent (the “Unit Agent”).
In connection with the opinions herein, we have examined originals or copies, satisfactory to us, of the Company’s Amended and Restated Articles of Association and resolutions
of the board of directors, and we have examined and relied without investigation as to matters of fact upon the Registration Statement and the exhibits thereto, and such certificates, statements and results of inquiries of public officials and
officers and representatives of the Company and originals or copies, certified or otherwise identified to our satisfaction, of such other documents, corporate records, certificates and instruments as we have deemed necessary or appropriate to enable
us to render the opinions expressed herein. We have assumed the genuineness of all signatures on all documents examined by us, the legal competence and capacity of natural persons, the authenticity of documents submitted to us as originals, and the
conformity with authentic original documents of all documents submitted to us as copies.
We also have assumed that: (1) at the time of execution, issuance and delivery of any Warrants, the related Warrant Agreement will be the valid and legally binding obligation of
the Warrant Agent, enforceable against such party in accordance with its terms; (2) at the time of execution, issuance and delivery of any Subscription Rights, the related Subscription Rights Agreement will be the valid and legally binding obligation
of the Rights Agent, enforceable against such party in accordance with its terms; and (3) at the time of the execution, issuance and delivery of the Units, the related Unit Agreement will be the valid and legally binding obligation of the Unit Agent,
enforceable against such party in accordance with its terms.
We have assumed further that: (1) at the time of execution, issuance and delivery of any Warrants, the related Warrant Agreement will have been duly authorized, executed and
delivered by the Company and the Warrant Agent; (2) at the time of execution, issuance and delivery of any Subscription Rights, the related Subscription Rights Agreement will have been duly authorized, executed and delivered by the Company and the
Rights Agent; (3) at the time of execution, issuance and delivery of the Units, the Unit Agreement will have been duly authorized, executed and delivered by the Company and the Unit Agent; and (4) at the time of the issuance and sale of any of the
Securities, the terms of the Securities, and their issuance and sale, will have been established so as not to violate any applicable law or result in a default under or breach of any agreement or instrument binding upon the Company and so as to
comply with any requirement or restriction imposed by any court or governmental body having jurisdiction over the Company.
For the purpose of the opinions expressed below, we have assumed further that after the issuance of the ADSs or the Ordinary Shares pursuant to the Registration Statement, the
total number of issued Ordinary Shares, together with the total number of Ordinary Shares reserved for issuance upon the exercise, exchange or conversion, as the case may be, of any exercisable, exchangeable or convertible security then outstanding,
will not exceed the total number of authorized share capital under the Company’s Amended and Restated Articles of Association.
Based upon the foregoing, in reliance thereon and subject to the assumptions, comments, qualifications, limitations and exceptions stated herein and the effectiveness of the
Registration Statement under the Act, we are of the opinion that:
| 1. |
With respect to the Ordinary Shares underlying ADSs and the Ordinary Shares, assuming the taking of all necessary corporate action to authorize and approve the issuance of any ADSs and/or Ordinary Shares, as the case may be, the terms of
the offering thereof and related matters, upon payment of the consideration therefor provided for in the applicable definitive purchase, underwriting or similar agreement approved by the board of directors and otherwise in accordance with the
provisions of the applicable Securities, if any, such Ordinary Shares will be validly issued, fully paid and non-assessable.
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| 2. |
With respect to the Warrants, assuming the (a) taking of all necessary corporate action to authorize and approve the issuance of the underlying Ordinary Shares and/or ADSs and the issuance and terms of any Warrants, the related Warrant
Agreement, the terms of the offering thereof and related matters and (b) due execution, authentication, issuance and delivery of such Warrants upon payment of the consideration therefor provided for in the applicable definitive purchase,
underwriting or similar agreement approved by the board of directors and otherwise in accordance with the provisions of the applicable Warrant Agreement, such Warrants will constitute valid and legally binding obligations of the Company to
the extent governed by Israeli law.
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2
| 3. |
With respect to the Subscription Rights, assuming the (a) taking of all necessary corporate action to authorize and approve the issuance and terms of any Subscription Rights, the related Subscription Rights Agreement and the Ordinary
Shares and/or ADSs underlying the Subscription Rights, the terms of the offering thereof and related matters and (b) due execution, countersignature (where applicable), authentication, issuance and delivery of such Subscription Rights upon
payment of the consideration therefor provided for in the applicable definitive purchase, underwriting or similar agreement approved by the board of directors and otherwise in accordance with the provisions of the applicable Subscription
Rights Agreement, such Subscription Rights will constitute valid and legally binding obligations of the Company to the extent governed by Israeli law.
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| 4. |
With respect to the Units, assuming the (a) taking of all necessary corporate action to authorize and approve the issuance and the terms of the Units, the related Unit Agreement and any Securities which are components of the Units, the
terms of the offering thereof and related matters and (b) due execution, countersignature (where applicable), authentication, issuance and delivery of the Units and the Securities that are components of such Units in each case upon the
payment of the consideration therefor provided for in the applicable definitive purchase, underwriting or similar agreement approved by the board of directors, and otherwise in accordance with the provisions of the applicable (i) Warrant
Agreement, in the case of Warrants and (ii) Subscription Rights Agreement, in the case of Subscription Rights, such Units will be validly issued and will entitle the holders thereof to the rights specified in the Unit Agreements to the extent
governed by Israeli law.
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In addition to the assumptions, comments, qualifications, limitations and exceptions set forth above, the opinions set forth herein are further limited by, subject to and based
upon the following assumptions, comments, qualifications, limitations and exceptions:
| a) |
We are members of the Israel Bar, and we express no opinion as to any matter relating to the laws of any jurisdiction other than the laws of the State of Israel and have not, for the purpose of giving this opinion, made any investigation
of the laws of any other jurisdiction than the State of Israel. The opinions set forth herein are made as of the date hereof and are subject to, and may be limited by, future changes in the factual matters set forth herein, and we undertake
no duty to advise you of the same. The opinions expressed herein are based upon the law in effect (and published or otherwise generally available) on the date hereof, and we assume no obligation to revise or supplement these opinions should
such law be changed by legislative action, judicial decision or otherwise. In rendering our opinions, we have not considered, and hereby disclaim any opinion as to, the application or impact of any laws, cases, decisions, rules or regulations
of any other jurisdiction, court or administrative agency. This opinion is expressly limited to the matters set forth above, and we render no opinion, whether by implication or otherwise, as to any other matters.
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3
| b) |
Our opinions herein are subject to and may be limited by (i) applicable bankruptcy, insolvency, reorganization, receivership, moratorium and other similar laws affecting or relating to the rights and remedies of creditors generally
including, without limitation, laws relative to fraudulent conveyances, preference and equitable subordination, (ii) general principles or equity (regardless of whether considered in a proceeding in equity or at law), (iii) an implied
covenant of good faith and fair dealing, (iv) requirements that a claim with respect to any Securities denominated other than in United States dollars (or a judgment denominated other than in United States dollars with respect to such a
claim) be converted into United States dollars at a rate of exchange prevailing on a date determined pursuant to applicable law, and (v) governmental authority to limit, delay or prohibit the making of payments outside the United States or in
foreign currency or composite currency.
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| c) |
Our opinions are further subject to the effect of generally applicable rules of law arising from statutes, judicial and administrative decisions, and the rules and regulations of governmental authorities that: (i) limit or affect the
enforcement of provisions of a contract that purport to require waiver of the obligations of good faith, fair dealing, diligence and reasonableness; (ii) limit the availability of a remedy under certain circumstances where another remedy has
been elected; (iii) limit the enforceability of provisions releasing, exculpating or exempting a party from, or requiring indemnification of a party for, liability for its own action or inaction, to the extent the action or inaction involves
negligence, recklessness, willful misconduct or unlawful conduct; (iv) may, where less than all of the contract may be unenforceable, limit the enforceability of the balance of the contract to circumstances in which the unenforceable portion
is not an essential part of the agreed exchange and (v) govern and afford judicial discretion regarding the determination of damages and entitlement to attorneys’ fees.
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| d) |
We express no opinion as to the enforceability of any provision in any Warrant Agreement, Subscription Rights Agreement, Unit Agreement or other agreement purporting or attempting to (A) confer exclusive jurisdiction and/or venue upon
certain courts or otherwise waive the defenses of forum non conveniens or improper venue, (B) confer subject matter jurisdiction on a court not having independent grounds therefor, (C) modify or waive the requirements for effective service of
process for any action that may be brought, (D) waive the right of the Company or any other person to a trial by jury, (E) provide that remedies are cumulative or that decisions by a party are conclusive, or (F) modify or waive the rights to
notice, legal defenses, statutes of limitations or other benefits that cannot be waived under applicable law.
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| e) |
We express no opinion as to the enforceability of any rights to indemnification or contribution provided for in any Warrant Agreement, Subscription Rights Agreement, Unit Agreement or other agreement which are violative of public policy
underlying any law, rule or regulation (including any federal or state securities law, rule or regulation) or the legality of such rights.
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| f) |
You have informed us that you intend to issue the Securities from time to time on a delayed or continuous basis, and this opinion is limited to the laws, including the rules and regulations, as in effect on the date hereof. We understand
that prior to issuing any Securities you will afford us an opportunity to review the corporate approvals and operative documents pursuant to which such Securities are to be issued (including the applicable Prospectus Supplement) and will file
such supplement or amendment to this opinion (if any) as we may reasonably consider necessary or appropriate by reason of the terms of such Securities.
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With respect to our opinion as to the ADSs and Ordinary Shares, including any ADSs and Ordinary Shares issued upon exercise or conversion of any Securities, we have assumed that, at the time of issuance and sale and to the extent any such
issuance would exceed the maximum share capital of the Company currently authorized, the number of Ordinary Shares that the Company is authorized to issue shall have been increased in accordance with the Company’s Articles of Association and
as described in the Registration Statement such that a sufficient number of Ordinary Shares are authorized and available for issuance under the Articles of Association.
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We hereby consent to the filing of this opinion as Exhibit 5.1 to the Registration Statement and to the use of our name under the caption “Legal Matters” in the Prospectus. We
also consent to your filing copies of this opinion as an exhibit to the Registration Statement with agencies of such states as you deem necessary in the course of complying with the laws of such states regarding the offering and sale of the
Securities. In giving such consent, we do not thereby concede that we are within the category of persons whose consent is required under Section 7 of the Act or the Rules and Regulations of the SEC thereunder.
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Very truly yours,
/s/ Goldfarb Gross Seligman & Co.
Goldfarb Gross Seligman & Co.
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5
Exhibit 5.2
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August 9, 2024
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
Ladies and Gentlemen:
We have acted as U.S. counsel to RedHill Biopharma Ltd., a company organized under the laws of the State of Israel (the “Company”),
in connection with the filing with the Securities and Exchange Commission (the “Commission”) on the date hereof, under the Securities Act of 1933, as amended (the “Act”), of a registration statement on Form F-3 (the “Registration Statement”) relating to (i) American Depositary Shares (“ADSs”), each ADS representing four hundred (400) ordinary shares, par value NIS 0.01 per share, of the Company (the “Ordinary Shares”); (ii) Ordinary Shares;
(iii) warrants to purchase Ordinary Shares and/or ADSs (the “Warrants”); (iv) subscription rights to purchase Ordinary Shares and/or ADSs (the “Subscription Rights”); and (v) units (the “Units”, and, together with the Warrants and the Subscription Rights, the “Securities”)
comprised of one or more of the ADSs, Ordinary Shares, Warrants and/or Subscription Rights, that may be issued and sold from time to time pursuant to Rule 415 under the Act for an aggregate offering price not to exceed $50,000,000. The ADSs will be
issued pursuant to a Deposit Agreement, dated as of December 26, 2012, by and among the Company, The Bank of New York Mellon, as depositary, and owners and holders from time to time of ADSs issued thereunder (the “Deposit Agreement”).
In rendering the opinions expressed herein, we have examined and relied upon the originals, or copies certified to our satisfaction, of (i) the Registration Statement and the
prospectus contained therein; (ii) the Deposit Agreement; and (iii) such other corporate records, documents and instruments of the Company as we have deemed necessary for the expression of the opinions stated herein.
As to questions of fact material to the opinions expressed below, we have, without independent verification of their accuracy, relied to the extent we deem reasonably appropriate
upon the representations and warranties of the Company contained in such documents, records, certificates, instruments or representations furnished or made available to us by the Company.
In making the foregoing examination, we have assumed certain matters with respect to the Company, including the valid existence, good standing, power and authority of the Company.
In addition, we have assumed (i) the genuineness of all signatures; (ii) the authenticity of all documents submitted to us as originals; (iii) the conformity to original documents of all documents submitted to us as certified or photostatic copies;
(iv) that all agreements or instruments we have examined are the valid, binding and enforceable obligations of the parties thereto (except with respect to the Company to the extent necessary to render Opinion 1 below); and (v) that all factual
information on which we have relied was accurate and complete.
RedHill Biopharma Ltd.
August 9, 2024
Page 2
We have also assumed that (i) the Company will continue to be organized and in existence and good standing under the law of the jurisdiction in which it is organized; (ii) the
Registration Statement, and any amendments thereto (including post-effective amendments), will have become effective; (iii) no stop order of the Commission preventing or suspending the use of the prospectus contained in the Registration Statement or
any prospectus supplement will have been issued; (iv) a prospectus supplement will have been prepared and filed with the Commission properly describing the ADSs and/or Securities, as applicable, offered thereby and will have been delivered to the
purchaser(s) of the ADSs and/or Securities, as applicable, as required in accordance with applicable law; (v) all ADSs and Securities will be offered, issued and sold in compliance with applicable federal and state securities laws and in the manner
stated in the Registration Statement and the appropriate prospectus supplement; (vi) a definitive purchase, underwriting or similar agreement with respect to any ADSs or Securities offered will have been duly authorized and validly executed and
delivered by the Company and the other parties thereto and will be an enforceable obligation of the parties thereto; (vii) in connection with the sale of Warrants, any required warrant agreement or agreement relating to the Warrants (a “Warrant Agreement”) will have been duly authorized, executed and delivered by all applicable parties and will be enforceable in all respects in accordance with its terms; (viii) in connection
with the issuance of Subscription Rights, any required subscription rights agreement or agreement relating to the Subscription Rights (a “Subscription Rights Agreement”) will have been duly
authorized, executed and delivered by all applicable parties and will be enforceable in all respects in accordance with its terms; (ix) in connection with the sale of Units, any required unit agreement or agreement relating to the Units (a “Unit Agreement”, and, together with the Warrant Agreement and the Subscription Rights Agreement, the “Agreements”) will have been duly
authorized, executed and delivered by all applicable parties and will be enforceable in all respects in accordance with its terms; (x) each of the ADSs, Deposit Agreement, Securities and applicable Agreements governing such Securities will be
governed by the internal laws of the State of New York; (xi) the execution and delivery of, and the performance of its obligations under, each Agreement by each party thereto will not (A) contravene such party’s articles or certificate of association
or incorporation, by-laws or similar organizational documents, (B) contravene any laws or governmental rules or regulations that may be applicable to such party or its assets, (C) contravene any judicial or administrative judgment, injunction, order
or decree that is binding upon such party or its assets, or (D) breach or result in a default under any contract, indenture, lease, or other agreement or instrument applicable to or binding upon such party or its assets; (xii) all consents,
approvals, licenses, authorizations, orders of, and all filings or registrations with, any governmental or regulatory authority or agency required under the laws of any jurisdiction for the execution and delivery of, and the performance of its
obligations under, each Agreement by each party thereto will be obtained or made and in full force and effect; (xiii) there are no agreements or other arrangements that modify, supersede, novate, terminate or otherwise alter any of the terms of any
Agreement; and (xiv) any securities issuable upon conversion, exchange, redemption or exercise of any ADSs or Securities being offered will be duly and validly authorized, created and, if appropriate, reserved for issuance upon such conversion,
exchange, redemption or exercise.
Based on the foregoing, and subject to the limitations and qualifications set forth herein, we are of the opinion that:
1. When the ADSs are issued in accordance with the Deposit Agreement against the deposit of duly authorized, validly issued, fully paid and non-assessable Ordinary Shares, such
ADSs will be duly and validly issued under the Deposit Agreement and will entitle the holders thereof to the rights specified therein.
2. With respect to the Securities, when (i) the Board of Directors of the Company or a duly authorized committee thereof (the “Board”)
has taken all necessary corporate action to approve the creation of and the issuance and terms of the applicable Security, the terms of the offering thereof and related matters; (ii) the applicable Agreements and Securities have been duly prepared,
authorized and validly executed and delivered by the Company and the other parties thereto (if any) in compliance with all applicable laws; and (iii) the applicable Securities or certificates representing the applicable Securities have been duly
registered and delivered in accordance with the appropriate Agreements and the applicable definitive purchase, underwriting or similar agreement approved by the Board and upon payment of the consideration therefor provided for therein, all in
accordance with the Registration Statement and any prospectus supplement, the Securities will constitute valid and legally binding obligations of the Company.
RedHill Biopharma Ltd.
August 9, 2024
Page 3
The opinions set forth above are subject to the following qualifications, limitations and exceptions:
(a) The opinions are subject to (i) the effect of any applicable bankruptcy, insolvency, reorganization, moratorium, rearrangement, liquidation, conservatorship or other similar
laws now or hereafter in effect relating to or affecting the rights of creditors generally; (ii) provisions of applicable law pertaining to the voidability of preferential or fraudulent transfers and conveyances; and (iii) the fact that the remedy of
specific performance and injunctive and other forms of equitable relief may be subject to equitable defenses and to the discretion of the court before which any proceeding therefor may be brought.
(b) The opinions are subject to the effect of (i) general principles of equity, including (without limitation) concepts of materiality, reasonableness, good faith and fair dealing,
general matters of public policy and other similar doctrines generally affecting the enforceability of agreements (regardless of whether considered in a proceeding in equity or at law); (ii) obligations of good faith and fair dealing under New York
law; (iii) provisions purporting to make a guarantor primarily liable rather than as a surety; and (iv) other commonly-recognized statutory and judicial constraints on enforceability, including statutes of limitation, limitations on rights to
indemnification that contravene law or public policy and the effectiveness of waivers of rights or benefits that cannot be effectively waived under applicable law.
(c) In rendering the opinions set forth above, we have assumed that, at the time of the sale of the ADSs and/or Securities, as applicable, (i) the resolutions of the Board or
similar governing body, as reflected in the minutes and proceedings of the Company, will not have been modified or rescinded; and (ii) there will not have occurred any change in the laws affecting the authorization, execution, delivery, issuance,
sale, ranking, validity or enforceability of the ADSs and/or Securities, as applicable.
The opinions expressed herein are limited to the federal laws of the United States of America, and, to the extent relevant to the opinions expressed herein, the laws of the State
of New York, in each case as in effect on the date hereof (all of the foregoing being referred to as the “Opined on Law”). We do not express any opinion with respect to any other laws, or
the laws of any other jurisdiction (including, without limitation, any laws of any other jurisdiction which might be referenced by the choice-of-law rules of the Opined on Law), other than the Opined on Law, or as to the effect of any such other laws
on the opinions herein stated. Various issues concerning the laws of the State of Israel are addressed in the opinion of Goldfarb Gross Seligman & Co. filed as an exhibit to the Registration Statement. We express no opinion with respect to those
matters herein, and to the extent elements of those opinions are necessary to the conclusions expressed herein, we have, with the Company’s consent, assumed such matters.
We hereby consent to the filing of this opinion as Exhibit 5.2 to the Registration Statement and to the reference to our firm contained therein under the heading “Legal Matters.”
In giving this consent, we do not hereby admit we are in the category of persons whose consent is required under Section 7 of the Act or the rules and regulations of the Commission thereunder.
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Very truly yours,
/s/ Haynes and Boone, LLP
Haynes and Boone, LLP
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Haynes and Boone, LLP
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30 Rockefeller Plaza | 26th Floor | New York, NY 10112
T: 212.659.7300 | haynesboone.com
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Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in this Registration Statement on Form F-3 of RedHill Biopharma Ltd. of our report dated April 8, 2024 relating to the financial statements and
the effectiveness of internal control over financial reporting, which appears in RedHill Biopharma Ltd.'s Annual Report on Form 20-F for the year ended December 31, 2023. We also consent to the reference to us under the heading “Experts” in such
Registration Statement.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Tel-Aviv, Israel
August 9, 2024
Kesselman & Kesselman, 146 Derech Menachem Begin St. Tel-Aviv 6492103, Israel,
P.O Box 7187 Tel-Aviv 6107120, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
P.O Box 7187 Tel-Aviv 6107120, Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il