Core Viewpoint - Hagens Berman is investigating Alvotech for potential misrepresentation regarding its lead drug candidate AVT05 and its manufacturing operations, following a significant revision to the company's financial forecasts for 2025 [1][2]. Financial Performance - Alvotech raised its 2025 revenue guidance to $600-$700 million and adjusted EBITDA to $200-$280 million on May 8, 2025, and reiterated these forecasts on August 14, 2025 [3]. - Following the FDA's issuance of a Complete Response Letter (CRL) on November 2, 2025, Alvotech revised its revenue forecast down to $570-$600 million and adjusted EBITDA to $130-$150 million, representing a 10% decrease in revenue and a 58% decrease in adjusted EBITDA from prior projections [3][4]. Market Reaction - The announcement of the CRL led to a 33% drop in Alvotech's share price on November 3, 2025, resulting in a loss of hundreds of millions of dollars in market value in a single day [4]. Investigation Focus - The investigation by Hagens Berman centers on whether Alvotech adequately disclosed the status of its Biologics License Application for AVT05 and the manufacturing practices at its Reykjavik facility, which were critical to the company's revenue projections [2][5].
Alvotech (ALVO) Faces Investor Scrutiny Amid Manufacturing Deficiencies Severely Impacting Assurances of 2025 Revenues and Adjusted EBITDA, Stock Tumbles 33% -- Hagens Berman