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Investing.com - Deutsche Bank downgraded Alvotech SA (NASDAQ:ALVO) from Buy to Hold and cut its price target to $8.00 from $14.00 following manufacturing concerns identified by regulators.
The downgrade comes after Alvotech received a Complete Response Letter (CRL) from the FDA for its biosimilar AVT05 (bSimponi) application. The CRL highlighted deficiencies found during an FDA inspection of the company’s Reykjavik manufacturing facility that must be resolved before approval.
In response to these regulatory challenges, Alvotech has reduced its 2025 financial outlook, now guiding for total revenues of $570-600 million and adjusted EBITDA of $130-150 million. These revised figures represent reductions of approximately 10% for revenue and 42% for EBITDA at their respective midpoints.
The company attributed the more significant EBITDA guidance cut to additional investments needed to resolve the facility issues identified by regulators. Management confirmed to Deutsche Bank that the manufacturing concerns could potentially lead to CRLs for two other products in its pipeline, AVT03 and AVT06.
Alvotech expects to receive further instructions from the FDA in the coming weeks, though the company has not provided a timeline for when the manufacturing issues will be fully resolved.
In other recent news, Alvotech reported strong financial results for the second quarter of 2025, with earnings per share reaching $0.50, significantly surpassing the anticipated -$0.0023. Revenue also exceeded expectations, hitting $204.7 million compared to the forecasted $120.51 million. In regulatory developments, the U.S. Food and Drug Administration issued a complete response letter for Alvotech’s biosimilar candidate to Simponi, citing deficiencies at the company’s Reykjavik facility that need resolution before approval. Meanwhile, the European Medicines Agency’s committee recommended approval for Alvotech’s denosumab biosimilar, pending final European Commission approval. Alvotech also secured Japanese approval for three biosimilars, including the first golimumab biosimilar approved in major markets globally. Morgan Stanley upgraded Alvotech’s stock rating to Overweight, acknowledging the company’s global growth and successful product launches. These recent developments paint a dynamic picture for Alvotech as it continues to advance its biosimilar portfolio.
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