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 ...

Revenue and Financial Performance - Total revenue for full year 2022 increased by 114% to $85.0 million, compared to $39.7 million in 2021, driven by milestone and product revenue from AVT02 commercialization [3]. - Product revenue from AVT02 sales in selected European countries and Canada was $24.8 million, with license and other revenue totaling $58.2 million [7]. - Product revenue for 2022 was $24.836 million, with no revenue reported in 2021 and 2020 [24]. - License and other revenue increased to $58.193 million in 2022 from $36.772 million in 2021, but decreased from $66.616 million in 2020 [24]. - The company reported a loss for the year of $(513,580) thousand, compared to $(101,504) thousand in 2021, indicating a significant increase in losses [30]. - Basic and diluted loss per share for 2022 was $(2.60), compared to $(0.92) in 2021 [24]. Expenses - R&D expenses for 2022 were $180.6 million, a decrease from $191.0 million in 2021, primarily due to costs being recognized as product revenue following the first commercial launch [9]. - G&A expenses rose to $186.7 million in 2022, up from $84.1 million in 2021, largely due to a non-cash share listing expense of $83.4 million [10]. - Research and development expenses were $180.622 million in 2022, slightly down from $191.006 million in 2021 [24]. - General and administrative expenses rose significantly to $186.742 million in 2022 from $84.134 million in 2021 [24]. - Finance costs rose to $188,419 thousand from $117,361 thousand in 2021, indicating higher borrowing costs [30]. Cash Flow and Liquidity - Cash and cash equivalents as of December 31, 2022, were $66.4 million, with total borrowings of $764.6 million [6]. - Cash and cash equivalents increased to $66.427 million in 2022 from $17.556 million in 2021 [26]. - Operating cash flow before movement in working capital was $(228,861) thousand, worsening from $(193,220) thousand in the previous year [30]. - Net cash used in operating activities increased to $(312,389) thousand from $(228,170) thousand in 2021 [30]. - Net cash used in investing activities was $(63,537) thousand, up from $(40,633) thousand in 2021, reflecting increased capital expenditures [31]. - The company generated net cash from financing activities of $424,910 thousand, compared to $254,831 thousand in the previous year, driven by new borrowings [31]. - Cash and cash equivalents at the end of the year increased to $66,427 thousand from $17,556 thousand in 2021, showing improved liquidity [31]. Assets and Liabilities - Total assets increased to $828.443 million in 2022 from $597.977 million in 2021 [26]. - Total liabilities rose to $1.392859 billion in 2022, up from $733.589 million in 2021 [28]. - The accumulated deficit reached $1.654114 billion in 2022, compared to $1.140534 billion in 2021 [28]. Development and Regulatory Updates - The FDA confirmed a new goal date for AVT02's BLA of April 13, 2023, with a reinspection of the Reykjavik facility scheduled for March 6, 2023 [2]. - Alvotech advanced three biosimilar candidates into clinical development in 2022: AVT03, AVT05, and AVT06 [3]. - Alvotech's product pipeline includes eight biosimilar candidates targeting various diseases, with strategic partnerships established for global market reach [19]. Other Financial Information - The company incurred share listing expenses of $83,411 thousand, which were not present in the previous year [30]. - The company reported an income tax benefit of $(38,067) thousand, an improvement from $(47,694) thousand in the previous year [30]. - The company experienced an increase in inventories and trade receivables, leading to a cash outflow of $(32,412) thousand and $(3,576) thousand respectively [30].

Alvotech (NASDAQ:ALVO) Q3 2022 Earnings Conference Call November 16, 2022 8:00 AM ET Company Participants Benedikt Stefansson - Director of Investor Relations and Global Communication Robert Wessman - Executive Chairman & Founder Anil Okay - Chief Commercial Officer Mark Levick - Chief Executive Officer Joel Morales - Chief Financial Officer Conference Call Participants Mark Bavoso - Morgan Stanley Andrew Baum - Citi Carl Byrnes - Northland Capital Markets Ash Verma - UBS Operator Good day, and thank you fo ...

Alvotech (NASDAQ:ALVO) Q2 2022 Earnings Conference Call September 1, 2022 8:00 AM ET Company Participants Benedict Stephan - Investor Relations Robert Wessman - Executive Chairman & Founder Mark Levick - Chief Executive Officer Anil Okay - Chief Commercial Officer Joel Morales - Chief Financial Officer Ming Li - Chief Strategic Officer Conference Call Participants Tybalt Mornan - Morgan Stanley Karen Marchetti - Northland Jason Guerra - Bank of America Benedict Stephan [Call Started Abruptly] materials and ...