Alvotech 6-K/A, filed Jul 1, 2024
Alvotech (ALVO)
About this 6-K/A
Alvotech filed this 6-K/A on July 1, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K/A
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of July 2024
Commission File Number: 001-41421
Alvotech
(Translation of registrant’s name into English)
9, Rue de Bitbourg,
L-1273 Luxembourg,
Grand Duchy of Luxembourg
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
This Report on Form 6-K/A (this “Report”) amends the Report on Form 6-K filed by Alvotech (the “Company”) on July 1, 2024 (the “Original 6-K”) solely to incorporate by reference the information contained on this Report into registration statements of the Company, as indicated in the section “Incorporation by Reference” below.
Except as described above, this Report speaks as of the original filing date of the Original 6-K and does not amend, update or restate any information set forth in the Original 6-K or reflect any events that occurred subsequent to the original filing date of the Original 6-K.
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
Preliminary Unaudited Financial Results for the Second Quarter of 2024
Preliminary Unaudited Financial Results
On July 1, 2024, the Company issued a press release announcing preliminary unaudited financial results for the quarter ended June 30, 2024. The Company preliminarily estimates that:
| · | Preliminary total revenues for the second quarter of 2024 between $196 - $201 million. Preliminary total revenues for the first six months of 2024 are $233 - $238 million, an approximately 10-fold increase compared to total revenues for the same period in 2023. |
| · | Preliminary product revenues from global sales of Alvotech’s biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab), for the second quarter of 2024 are $51 – $54 million. Preliminary growth in the first half of 2024 of approximately 180% year-over-year compared to the same period in 2023, with product revenues of $63 - $66 million for the first six months of 2024. |
| · | Preliminary milestone revenues in the second quarter of 2024 are $145 - $147 million or $169 - $171 million for the first six months of 2024, primarily due to the achievement of top-line clinical results for certain clinical programs and multiple global product launches in the second quarter of 2024. |
| · | Preliminary adjusted EBITDA is $98 - $103 million for the second quarter of 2024 or $60 - $65 million for the first six months of the year. This compares to an adjusted EBITDA loss of ($178) million for the first half of 2023. |
This information reflects the Company’s preliminary estimates, based on currently available information. The Company has provided estimated ranges, rather than point estimates, primarily because financial closing procedures for the quarter are not yet completed and final results may therefore vary from these estimates. These preliminary estimates have not been audited by the Company’s independent registered public accounting firm.
A copy of the Company’s press release is furnished herewith as Exhibit 99.1 to this Report.
Non-IFRS Financial Measures
Adjusted EBITDA is a non-IFRS measure which is defined in the Company’s latest Annual Report on Form 20-F filed with the SEC. The Company has presented its expectations regarding adjusted EBITDA without presenting the most directly comparable IFRS measure or a corresponding quantitative reconciliation, as such information is not available to the Company without unreasonable efforts at the time of the release of this preliminary financial information. The Company is not able to estimate net (loss) income on a forward-looking basis without unreasonable efforts due to the variability and complexity with respect to the charges excluded from adjusted EBITDA.
Cautionary note on forward-looking statements
This Report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this Report are forward-looking statements. These statements include, but are, but not limited to, statements regarding the Company’s preliminary unaudited financial and operating results for the second quarter of 2024. These forward-looking statements are based on the Company’s expectations and assumptions as of
the date of this Report. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those expressed or implied by these forward-looking statements. For a discussion of risk factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this Report, you should refer to the Company’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing the Company’s views as of any date subsequent to the date of this Report.
The unaudited, estimated results for the quarter ended June 30, 2024 in this Report on Form 6-K are preliminary financial information, remain subject to completion, and were prepared by the Company’s management based upon estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter-end closing procedures and/or adjustments, the completion of the Company’s financial statements and other operational procedures. In addition, the Company’s independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information.
INCORPORATION BY REFERENCE
This Report, excluding Exhibit 99.1 attached hereto, shall be deemed to be incorporated by reference into the Company’s registration statements on Form F-3 (File Nos. 333-266136, 333-273262 and 333-275111) and the Company’s registration statement on Form S-8 (File No. 333-266881), including any prospectuses forming a part of such registration statements, and to be a part thereof from the date on which this Report is filed, to the extent not superseded by documents or reports subsequently filed or furnished. Exhibit 99.1 to this Report is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
|
Exhibit No. |
Description | |
| 99.1 | Press Release. |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| ALVOTECH | |||||
| Date: | July 1, 2024 | By: | /s/ Tanya Zharov | ||
| Name: | Tanya Zharov | ||||
| Title: | General Counsel | ||||
EXHIBIT 99.1
Alvotech Announces Record Preliminary Results for Revenues and EBITDA for the Second Quarter of 2024
REYKJAVIK, Iceland, July 01, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in
the development and manufacture of biosimilar medicines for patients worldwide, today announced certain preliminary, unaudited key financial
information for the second quarter and six months ended June 30, 2024, as follows:
- Strong preliminary revenue growth with total revenues for the second quarter between $196 - $201 million. Preliminary total revenues for the first six months are $233 - $238 million, an approximately 10-fold increase compared to total revenues for the same period in 2023.
- Preliminary product revenues, from global sales of Alvotech’s biosimilars to Humira® (adalimumab) and Stelara® (ustekinumab), for the second quarter are $51 – $54 million. Preliminary growth in the first half of approximately 180% year-over-year compared to the same period in 2023, with product revenues of $63 - $66 million for the first six months of this year.
- Preliminary milestone revenues in the second quarter are $145 - $147 million or $169 - $171 million for the first six months of 2024, primarily due to the achievement of top-line clinical results for certain clinical programs and multiple global product launches in the second quarter.
- Record quarter in terms of preliminary adjusted EBITDA. Preliminary adjusted EBITDA is $98 - $103 million for the second quarter or $60 - $65 million for the first six months of the year. This compares to an adjusted EBITDA loss of ($178) million for the first half of 2023.
“We are very pleased with the preliminary outcome of the second quarter of 2024, with strong anticipated milestone revenues as well as significant growth in product revenues. We expect record operating performance, with positive adjusted EBITDA for the first time both for the quarter and the first half of the year. We expect that these results, in combination with our debt refinancing, will put us in an optimal position to drive revenue growth and profitability for the full year,” said Robert Wessman, Chairman and CEO of Alvotech.
This information reflects Alvotech’s preliminary estimates, based on currently available information. Alvotech has provided estimated ranges, rather than point estimates, primarily because financial closing procedures for the quarter are not yet completed and final results may therefore vary from these estimates. These preliminary estimates have not been audited by our independent registered public accounting firm.
The information in the press release is information that Alvotech is obliged to make public pursuant to the EU Market Abuse Regulation (MAR).
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and
manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering
high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech
has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune
disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships
to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian
countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a
US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA,
UK, Switzerland, Canada, Australia and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP
Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore,
Indonesia, India, Bangladesh and
Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
Non-IFRS Financial Measures
Adjusted EBITDA is a non-IFRS measure which is defined in our latest Annual Report
on Form 20-F filed with the SEC. Alvotech has presented its expectations regarding adjusted EBITDA without presenting the most directly
comparable IFRS measure or a corresponding quantitative reconciliation, as such information is not available to Alvotech without unreasonable
efforts at the time of the release of this preliminary financial information. Alvotech is not able to estimate net (loss) income on a
forward-looking basis without unreasonable efforts due to the variability and complexity with respect to the charges excluded from adjusted
EBITDA.
Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to
future events or the future financial operating performance of Alvotech and may include, for example, Alvotech’s expectations regarding
its unaudited financial results for the three and six months ended June 30, 2024, forecasts and estimates with respect to financial results
for the full year 2024, including expectations and assumptions in connection with growth, expected product and milestone revenue, the
benefits or its debt refinancing, its ability to satisfy conditions precedent to close the debt refinancing and draw down the loan, to
comply with the covenants of the debt refinancing and to exercise its rights under the debt refinancing agreements, competitive advantages,
business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities,
performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and
commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking
statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”,
“aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are
subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied
by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable
by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of
which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but
are not limited to: (1) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all;
(2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that
Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech’s estimates of expenses and profitability;
(6) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory
authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations;
(8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators;
(9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners
to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech’s partners to conduct,
supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech’s
ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion
into additional markets or geographies; (13) the success of Alvotech’s current and future collaborations, joint ventures, partnerships
or licensing arrangements; (14) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for
approved products; (15) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing
and future litigation regarding Alvotech’s products and product candidates; (17) the impact of worsening macroeconomic conditions, including
rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other
global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones; (18) Alvotech’s ability to meet the conditions precedent to close the debt refinancing and comply with the covenants of the agreements; and (19) other risks and uncertainties set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. The above unaudited, estimated results for the quarter ended June 30, 2024 are preliminary financial information, remain subject to completion, and were prepared by management based upon estimates, a number of assumptions and currently available information, and are subject to revision based upon, among other things, quarter-end closing procedures and/or adjustments, the completion of our financial statements and other operational procedures. In addition, our independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to this preliminary financial information and does not express an opinion or any other form of assurance with respect to this preliminary financial information.
ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS
Benedikt Stefansson, VP
alvotech.ir@alvotech.com
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