Alvotech (NasdaqGM:ALVO) Q4 2025 Earnings call March 19, 2026 08:00 AM ET Company ParticipantsBenedikt Stefansson - Senior Director of Investor RelationsGlen Santangelo - Managing DirectorJoseph E. McClellan - COOLinda Jónsdóttir - CFOLisa Graver - Chief Executive Officer DesignateRóbert Wessman - Founder and Executive ChairmanConference Call ParticipantsArvid Näsander - Equity Research AnalystAshwani Verma - Equity AnalystChristopher Uhde - Senior Pharma and Biotech Equity AnalystOperatorGood day, and than ...

Core Insights - Alvotech reported total revenues of $593 million for FY 2025, reflecting a 21% year-on-year increase [3] - The company has launched three newly approved biosimilars and has a pipeline of 30 biosimilars in development [5][6] - Alvotech anticipates total revenues of $650-700 million for 2026, with adjusted EBITDA expected to rise to $180-220 million [11] Financial Performance - Total revenues for Q4 2025 were $173 million, a 13% increase year-on-year [7] - Adjusted EBITDA for FY 2025 was $137 million, up 27% year-on-year, with a gross margin of 61% [7] - The cash balance as of December 31, 2025, was $172 million [7] Product Development and Approvals - Alvotech has five approved biosimilars on the market, including products referencing Humira®, Stelara®, and Simponi® [18] - Recent approvals include AVT05 as a biosimilar to Simponi® and AVT03 as a biosimilar to Prolia® and Xgeva® in the EEA [7] - The company expects to receive U.S. approval for four Biologics License Applications by late 2026 [12] Strategic Initiatives - Alvotech raised nearly $300 million from capital markets to support its development programs and manufacturing platform [6] - The company has expanded its global reach through new commercial partnerships and acquisitions, including the R&D organization of Xbrane in Sweden [6][7] - Leadership changes include the appointment of Lisa Graver as Chief Executive Officer and other key management roles [10] Market Outlook - Management reaffirms its outlook for 2026, focusing on cash flow and margin expansion [11] - The anticipated revenue range for 2026 reflects continued double-digit sales growth [11] - The company is addressing regulatory observations from the FDA inspection of its Reykjavik manufacturing facility and plans to resubmit applications in Q2 2026 [9]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1]. Group 1: Legal Action and Investor Rights - Shareholders who purchased Alvotech securities may be entitled to compensation through a class action lawsuit without any out-of-pocket fees [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to Alvotech [2]. Group 2: Company Performance and Stock Impact - On November 2, 2025, Alvotech announced that the FDA issued a complete response letter for its Biologics License Application for AVT05, citing deficiencies from a pre-license inspection of its Reykjavik manufacturing facility [3]. - Following this announcement, Alvotech's stock price dropped by 34% on November 3, 2025, and nearly 4% on November 4, 2025 [3]. Group 3: Rosen Law Firm's Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company and being ranked No. 1 for settlements in 2017 [4]. - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Alvotech's stock price experienced a significant decline of 34% on November 3, 2025, following the announcement of a complete response letter (CRL) from the U.S. FDA regarding its Biologics License Application (BLA) for AVT05 [3]. - The CRL indicated that certain deficiencies identified during the FDA's pre-license inspection of Alvotech's Reykjavik manufacturing facility must be resolved before the BLA for AVT05 can be approved [3]. Group 2: Legal Actions - Investors who purchased Alvotech securities may be entitled to compensation through a class action lawsuit being prepared by Rosen Law Firm, which operates on a contingency fee basis [2]. - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a successful track record in securities class actions, highlighting its own achievements in recovering significant amounts for investors [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1] Group 1: Legal Action and Investor Rights - Shareholders who purchased Alvotech securities may be entitled to compensation through a class action without any out-of-pocket fees, facilitated by a contingency fee arrangement [2] - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to Alvotech [2] Group 2: Company Performance and Stock Impact - On November 2, 2025, Alvotech announced that the FDA issued a complete response letter for its Biologics License Application for AVT05, citing deficiencies from a pre-license inspection of its Reykjavik manufacturing facility [3] - Following this announcement, Alvotech's stock price dropped by 34% on November 3, 2025, and nearly 4% on November 4, 2025 [3] Group 3: Rosen Law Firm's Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company and being ranked highly for settlements since 2013 [4] - In 2019, the firm secured over $438 million for investors, showcasing its capability in recovering significant amounts for clients [4]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Alvotech's stock price experienced a significant decline of 34% on November 3, 2025, following the announcement of a complete response letter (CRL) from the U.S. FDA regarding its Biologics License Application (BLA) for AVT05 [3]. - The CRL indicated that certain deficiencies identified during the FDA's pre-license inspection of Alvotech's Reykjavik manufacturing facility must be resolved before the BLA for AVT05 can be approved [3]. Group 2: Legal Actions - Investors who purchased Alvotech securities may be eligible for compensation through a class action lawsuit being prepared by Rosen Law Firm, which operates on a contingency fee basis [2]. - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in recovering substantial amounts for investors [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Alvotech's stock price experienced a significant decline of 34% on November 3, 2025, following the announcement of a complete response letter (CRL) from the U.S. FDA regarding its Biologics License Application for AVT05 [3]. - The CRL indicated that certain deficiencies identified during the FDA's pre-license inspection of Alvotech's Reykjavik manufacturing facility must be resolved before the BLA for AVT05 can be approved [3]. Group 2: Legal Actions - Investors who purchased Alvotech securities may be eligible for compensation through a class action lawsuit, with no out-of-pocket fees or costs due to a contingency fee arrangement [2]. - The Rosen Law Firm is preparing a class action to seek recovery of investor losses related to Alvotech [2]. Group 3: Rosen Law Firm Credentials - The Rosen Law Firm has a strong track record in securities class actions, having achieved the largest securities class action settlement against a Chinese company and being ranked No. 1 for the number of settlements in 2017 [4]. - The firm has recovered hundreds of millions of dollars for investors, securing over $438 million in 2019 alone [4].

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1] Group 1: Company Overview - Alvotech is facing scrutiny after the U.S. FDA issued a complete response letter for its Biologics License Application for AVT05, indicating deficiencies that must be resolved before approval [3] - Following the FDA's announcement, Alvotech's stock price experienced a significant decline, falling 34% on November 3, 2025, and nearly 4% on November 4, 2025 [3] Group 2: Legal Actions - Investors who purchased Alvotech securities may be entitled to compensation through a class action lawsuit being prepared by Rosen Law Firm, which operates on a contingency fee basis [2] - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions, highlighting its own success in recovering substantial amounts for investors [4]

Core Viewpoint - Rosen Law Firm is investigating potential securities claims on behalf of shareholders of Alvotech due to allegations of materially misleading business information issued by the company [1]. Group 1: Company Information - Alvotech's stock price experienced a significant decline of 34% on November 3, 2025, following the announcement of a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AVT05 [3]. - The FDA's CRL indicated that certain deficiencies identified during a pre-license inspection of Alvotech's Reykjavik manufacturing facility must be resolved before the BLA for AVT05 can be approved [3]. Group 2: Legal Action - Investors who purchased Alvotech securities may be entitled to compensation through a class action lawsuit being prepared by Rosen Law Firm, which operates on a contingency fee basis [2]. - The Rosen Law Firm has a strong track record in securities class actions, having achieved significant settlements for investors, including over $438 million in 2019 alone [4].

Core Viewpoint - Hagens Berman is investigating Alvotech regarding its disclosures related to manufacturing operations and the regulatory status of its lead biosimilar candidate, AVT05, following a significant stock drop of 34% after receiving a Complete Response Letter from the FDA [1] Company Summary - Alvotech's stock experienced a 34% decline after the announcement of receiving a Complete Response Letter (CRL) from the FDA [1] - The investigation by Hagens Berman focuses on the propriety of Alvotech's disclosures concerning its manufacturing operations [1] - The regulatory status of Alvotech's lead biosimilar candidate, AVT05, is under scrutiny as part of the investigation [1]