VA-ALVOTECH

Alvotech Holdings SA today announced that it has entered into an amendment and restatement agreement with bondholders of its $300m covertible bond issued on December 14, 2018. Bondholders have exercised their conversion rights on approximately one quarter of the value of the bond, converting $106m of principal and accrued interest into equity at an exercise price that gives the company a pre-money valuation of $2.7bn.

The company and bondholders also agreed to improve terms on the remaining bond and extend its maturity to 2025, thereby decreasing the company's cost of capital and freeing resources to apply to the execution of its business strategy. Further terms were amended to add additional capital to the company.

Robert Wessman, Chairman of Alvotech commented: “With this transaction our stakeholders have reiterated their longstanding confidence in and commitment to our mission: to increase access to the highest quality biologics medicines for patients around the world.”

In November of 2020, the U.S. Food and Drug Administration and European Medicines Agency accepted Alvotech’s regulatory submissions for AVT02, a candidate interchangeable biosimilar to AbbVie’s Humira®. A decision from the FDA regarding the company’s Biologics License Application (BLA) for AVT02 is expected in September of 2021 and an EMA decision for the AVT02 European Marketing Authorization Application (MAA) is anticipated in the fourth quarter of 2021.

In May 2021, Alvotech USA Inc. filed a lawsuit in the Eastern District of Virginia seeking to invalidate four of AbbVie’s key patents. The lawsuit also argues that AbbVie’s patent strategy, which has been under recent Congressional scrutiny , renders its Humira® patents unenforceable. Further, the lawsuit points out that AbbVie has failed to sue Alvotech’s US affiliate (the actual BLA applicant) at all. At stake are billions of dollars of cost to the US healthcare system, negatively impacting consumers and taxpayers.

In June of 2021, Alvotech’s switching study for AVT02 reached primary completion. Alvotech is the only known company that has both developed a biosimilar candidate for the high-concentration Humira® and is executing a switching study to support approval as an interchangeable product. Top-line results from the switching study are expected later this year.

About Alvotech:

Alvotech is a multinational biopharmaceutical company focused on the development and manufacture of high quality biosimilars for global markets. We are specialists in biotechnology, seeking to be a global leader in the biosimilar space by delivering high quality, cost-competitive products and services to our partners and to patients worldwide. Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products. Alvotech’s shareholder base includes, among others, Aztiq Pharma, led by founder and Chairman Mr. Robert Wessman, Fuji Pharma from Japan, YAS Holdings form Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, ATHOS (Strüngmann Family Office) from Germany and CVC Capital Partners and Temasek from Singapore through their participation in Alvogen.

Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world. For more information, please visit our website, www.alvotech.com or follow us on LinkedIn , Twitter and Facebook.

Forward Looking Statement

Except for historical information contained herein, the matters set forth in this press release are forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are not based on historical facts but rather on our expectations regarding future growth, results of operations, performance, future capital and other expenditures, competitive advantages, business prospects and opportunities. Statements in this press release about our future plans and intentions, results, level of activities, performance, goals or achievements or other future events constitute forward looking statements. There are a number of factors which could cause actual results or developments to differ materially from those expressed or implied by such forward-looking statements. Any of the assumptions underlying forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in forward-looking statements may not actually be achieved. Nothing contained in this press release of them should be construed as a profit forecast or profit estimate. Wherever possible, words such as “anticipate”, “believe”, “expect”, “may”, “could”, “will”, “potential”, “intend”, “estimate”, “should”, “plan”, “predict”, or the negative or other variations of statements reflect management’s current beliefs and assumptions and are based on the information currently available to our management. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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