Alvotech (ALVO) Investigation

The central focus of the inquiry revolves around whether Alvotech provided adequate transparency to the market concerning the status of its Biologics License Application (BLA) for AVT05—a critical biosimilar product—and the underlying manufacturing practices at its flagship Reykjavik facility. The assumptions related to these practices were "baked into" the company's ambitious 2025 revenue projections.

On May 8, 2025, Alvotech increased its full year revenue guidance for 2025 to $600-$700 million and full year adjusted EBITDA to $200-$280 million.

Three months later, on August 14, 2025, the company reiterated these robust forecasts. Furthermore, in its earnings commentary, management touted its pending marketing application for AVT05 in “major global markets,” asserting this momentum would make "the fourth quarter… by far the strongest one of this year."

The narrative of steady growth was abruptly shattered on November 2, 2025, when Alvotech shocked investors when it announced the FDA issued a CRL that disclosed that “[t]e CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for ATV05 can be approved.”

The company reduced its 2025 revenue to $570-$600 million and adjusted EBITDA to just $130-$150 million, respectively. These reductions were critical to investors because they amounted to lowered forecasted revenue range by about 10% below the prior midpoint and a whopping lowered adjusted EBITDA range by about 58% from the prior midpoint.

As to the latter, Alvotech stated it was “primarily driven by expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production.”

The news sent Alvotech shares crashing about 33% on November 3, 2025, wiping out hundreds of millions of dollars in market value in a single day.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the ALVO investigation about?

We are focused on investors’ losses and whether Alvotech may have misled investors about its interactions with the FDA and the commercial prospects of ATV05.

WHAT SHOULD I DO?

I worked at ALVO. What should I do?

If you were an employee of ALVO, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, contact Reed Kathrein at 844-916-0895 or [email protected].

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in ALVO, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any ALVO investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.