REYKJAVIK, Iceland, Jan. 19, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech's facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the ...

Marketing authorization issued in European Economic Area for Uzpruvo®, the first biosimilar to Stelara®, a biologic therapy within gastroenterology, dermatology, and rheumatologyAuthorization paves way for biosimilar competition in the approximately €2.5 billion (US$2.7 billion) EU ustekinumab market as soon as possible after expiry of intellectual-property rights in July 2024Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity dat ...

Alvotech (NASDAQ:ALVO) Q3 2023 Earnings Conference Call November 29, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Senior Director of IR and Global Communications Robert Wessman - Chairman and CEO Anil Okay - Chief Commercial Officer Joel Morales - CFO Conference Call Participants Mikaela Franceschina - Barclays Niall Alexander - Deutsche Bank Thibault Boutherin - Morgan Stanley Operator Welcome to Alvotech's Earnings Call for the First Nine Months of 2023. At this time, all participants are in ...

First Six Months of 2023 Results and Business Update August 31, 2023 © ©AL AVLOVTOETCEHC. HA.L ALL RLI GRHIGTHST RSE RSEESREVREVDED Disclaimer ...

Alvotech (NASDAQ:ALVO) Q2 2023 Earnings Conference Call August 31, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Director of IR & Global Communications Robert Wessman - Chairman & CEO Anil Okay - Chief Commercial Officer Joel Morales - CFO Conference Call Participants Carl Byrnes - Northland Capital Markets Thibault Boutherin - Morgan Stanley Niall Alexander - Deutsche Bank Andrew Baum - Citi Operator Welcome to the Second Quarter 2023 Earnings Call for Alvotech. At this time, all participants ...

Financial Data and Key Metrics Changes - The company recorded total revenue of $16 million for Q1 2023, a significant increase from $1 million in the same period last year, driven by the first launch in the prior year [21] - The company ended Q1 2023 with approximately $116 million in cash on hand, excluding restricted cash of $25 million [20] - Cost of product revenue was disproportionately high relative to product revenue due to new launches and elevated production-related charges, but this is expected to normalize as manufacturing scales up [21][23] Business Line Data and Key Metrics Changes - AVT02, the biosimilar to Humira, has been launched in 70 markets, including Canada and Europe, with plans for additional launches in 2023 [9][18] - AVT05, a biosimilar candidate to Simponi, has initiated patient studies, marking the fifth product to reach this stage in the company's portfolio [13][14] - The company has also unveiled two new pipeline candidates: AVT16, a biosimilar to Entyvio, and AVT33, a proposed biosimilar to Keytruda, expanding its portfolio in immunology and oncology [15][16] Market Data and Key Metrics Changes - The high-concentration form of adalimumab (Humira) constitutes over 85% of the US market, highlighting the competitive landscape for AVT02 [8] - The global sales of Simponi and Simponi Aria exceeded $2 billion in 2022, indicating a substantial market opportunity for AVT05 [14] - Keytruda, with worldwide sales of over $20 billion in 2022, represents a significant market for the newly proposed AVT33 biosimilar [16] Company Strategy and Development Direction - The company aims to advance its global portfolio of biosimilar candidates while expanding its commercial footprint and partnerships [6] - Alvotech is committed to sustainability and has disclosed ESG indicators for 2022, aligning with recognized frameworks [7] - The company is exploring options to raise further capital to support its pipeline and potential US launches, reflecting a proactive approach to financial management [23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the approval process for AVT02, emphasizing the importance of high concentration and interchangeability in capturing market share [12] - The company is preparing for various scenarios regarding FDA approval timelines and is focused on expanding AVT02's market presence [23] - Management remains confident in the efficacy of biosimilars and their potential to penetrate the market similarly to other successful biosimilars [40] Other Important Information - The company is currently increasing the scale of its AVT02 manufacturing process to support upcoming launches [24] - Alvotech has 18 distinct partners covering over 90 markets, indicating a robust partnership network [18] Q&A Session Summary Question: FDA inspection and manufacturing site concerns - Management confirmed that while AVT02 and AVT04 are produced at the same facility, they believe they have sufficient time to resolve any issues before the FDA's decision [28] Question: Timing for FDA meeting and BLA resubmission - Management indicated that they are working on scheduling a meeting with the FDA and expect to resubmit the BLA after completing commitments towards manufacturing deficiencies [32][34] Question: Nature of FDA observations and freedom to operate in Stelara market - Management clarified that the observations from the recent inspection were primarily related to quality systems and that there are no repeat observations from previous inspections [37] Question: Keytruda biosimilar market potential - Management expressed confidence in the efficacy of biosimilars and stated that they are working with global authorities on study designs for AVT33 [41]

Alvotech (NASDAQ:ALVO) Q4 2022 Results Conference Call March 2, 2023 8:00 AM ET Company Participants Benedikt Stefansson - Director of Investor Relations Robert Wessman - Chairman and CEO Anil Okay - Chief Commercial Officer Hafrun Fridriksdottir - Chief Operating Officer Joel Morales - Chief Financial Officer Conference Call Participants Thibault Boutherin - Morgan Stanley Niall Alexander - Deutsche Bank Andrew Baum - Citi Benedikt Stefansson Thank you, and good morning or afternoon to everyone joining thi ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIE ...

Exhibit 99.1 REYKJAVIK, ICELAND (March 1, 2023) — Alvotech (NASDAQ: ALVO, or the "Company"), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for full year 2022 and provided a summary of recent corporate highlights. "Alvotech made significant progress in 2022. We were publicly listed, achieved a remarkable 114% increase in revenue, and were able to continue investing in and shaping our future through the ...