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    Did FDA’s AVT05 Setback and Guidance Cut Just Shift Alvotech’s (ALVO) Investment Narrative?

    Simply Wall St·12/15/2025 02:18:29
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    • Earlier in December 2025, law firm Hagens Berman began investigating Alvotech after the FDA issued a Complete Response Letter citing deficiencies at its Reykjavik manufacturing facility, prompting the company to sharply reduce its 2025 revenue and adjusted EBITDA guidance for its lead biosimilar candidate AVT05.
    • This combination of regulatory setbacks and questions over prior disclosures highlights how central manufacturing quality and transparent guidance are to Alvotech’s biosimilar-led business model.
    • With the FDA’s Complete Response Letter now public, we’ll examine how this manufacturing setback could reshape Alvotech’s investment narrative and risk profile.

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    Alvotech Investment Narrative Recap

    To own Alvotech, you need to believe its biosimilar portfolio can convert regulatory approvals into durable revenue despite execution bumps. The FDA’s Complete Response Letter on AVT05 directly affects the key near term catalyst for that asset and intensifies the biggest current risk around regulatory timing, manufacturing reliability and the “lumpy” milestone driven nature of Alvotech’s revenue and earnings.

    The recent cut to 2025 revenue guidance to US$570 million to US$600 million, following the FDA’s manufacturing findings in Reykjavik, is most relevant here because it ties regulatory progress, plant quality and financial outcomes together in a very visible way, sharpening investor focus on whether future approvals like AVT03 and other pipeline assets can offset AVT05 related delays.

    But set against that story of biosimilar opportunity is the less visible risk that investors should be aware of around...

    Read the full narrative on Alvotech (it's free!)

    Alvotech's narrative projects $1.4 billion revenue and $538.9 million earnings by 2028.

    Uncover how Alvotech's forecasts yield a $26.40 fair value, a 374% upside to its current price.

    Exploring Other Perspectives

    ALVO 1-Year Stock Price Chart
    ALVO 1-Year Stock Price Chart

    Seven members of the Simply Wall St Community currently see Alvotech’s fair value anywhere between US$14 and US$2,650.56, underlining how far apart views on the company’s prospects are. Against that spread, the recent FDA manufacturing setback and associated guidance cut underline why many investors are now reassessing how much regulatory and quality risk they are prepared to underwrite in Alvotech’s story.

    Explore 7 other fair value estimates on Alvotech - why the stock might be a potential multi-bagger!

    Build Your Own Alvotech Narrative

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    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.