Workflow
Alvotech(ALVO)
icon
Search documents
Alvotech(ALVO) - 2023 Q1 - Earnings Call Transcript
2023-05-19 18:15
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(ALVO) - 2022 Q4 - Earnings Call Transcript
2023-03-06 16:44
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 ...
Alvotech(ALVO) - 2022 Q4 - Annual Report
2023-03-01 22:03
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 ...
Alvotech(ALVO) - 2023 Q1 - Quarterly Report
2023-02-28 16:00
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 ...
Alvotech(ALVO) - 2022 Q3 - Earnings Call Transcript
2022-11-16 17:56
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(ALVO) - 2022 Q2 - Earnings Call Transcript
2022-09-01 18:16
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 ...