Alvotech reported its Q3 2025 earnings, posting earnings per share of $0.47 against a consensus estimate of –$0.03 and revenue of $114 million versus the $115.2 million forecasted by analysts. The company’s results fell short on both earnings and revenue, marking a significant miss in the quarter’s financial performance.
The earnings miss was largely driven by a Complete Response Letter issued by the FDA for the AVT05 product, which forced the company to halt production at its Reykjavik facility and incur additional compliance costs. The letter also delayed the start of expected licensing agreements, reducing licensing revenue and compressing product margins. The product margin for the quarter slipped to 27% from higher levels in prior periods, while the gross margin remained robust at 59% thanks to the licensing model.
In response to the regulatory setback, Alvotech revised its full‑year outlook. Management now projects revenue of $570 million to $600 million and adjusted EBITDA of $130 million to $150 million, a downward adjustment from the earlier guidance that had been based on a smoother regulatory path. The guidance shift signals caution about near‑term execution while still reflecting confidence in the company’s long‑term pipeline.
Segment analysis shows that product revenue grew 24% year‑over‑year for the first nine months of 2025, driven by strong demand for its Humira and Stelara biosimilars. However, Q3 licensing revenue declined, contributing to the overall revenue miss. CEO Robert Wessman emphasized that resolving the FDA inspection issues remains a top priority, noting that the quarter was otherwise marked by robust license revenues and high gross margins.
Investors reacted negatively to the earnings miss and the regulatory uncertainty, reflecting concerns about the company’s ability to meet its revised guidance. The market’s response underscores the weight of the FDA’s decision and the impact of licensing revenue fluctuations on Alvotech’s financial outlook.
Despite the short‑term headwinds, Alvotech’s pipeline remains a source of optimism. The company has secured approvals for new biosimilars in Japan and Europe and plans launches of additional products in those markets, positioning it to capture growth once regulatory challenges are resolved.
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