Alvotech reported first‑nine‑month 2025 results on November 12, 2025, with total revenue of $420 million—$237 million from product sales and $182 million from licensing and other sources—an 85 % year‑over‑year increase in product revenue. Operating profit reached $30 million, and the company ended September 30 with $43 million in cash and $1.1 billion in borrowings, underscoring a solid liquidity position amid expanding commercial activity. The company’s Q3 2025 earnings per share were $0.47, beating the consensus estimate of –$0.03 by $0.50 and marking a significant upside relative to expectations. Revenue for the quarter, however, fell slightly short of consensus, coming in at $114 million versus the $115.2–120 million range projected by analysts, a miss of roughly 1 %. The beat in EPS was driven by disciplined cost management and a favorable product mix, while the revenue shortfall reflected a modest decline in licensing income and a temporary slowdown in production at the Reykjavik facility.
Alvotech lowered its full‑year 2025 guidance on November 4, 2025, reducing revenue expectations to $570–$600 million from the previously raised $600–$700 million range, and adjusted EBITDA guidance to $130–$150 million from the earlier $200–$280 million outlook. The cut reflects the impact of a Complete Response Letter issued by the FDA that identified deficiencies at the Reykjavik plant, necessitating corrective actions and a temporary production slowdown. Management indicated that the slowdown will reduce product throughput in the short term, dampening revenue growth and compressing margins until the facility is fully compliant and production ramps back up.
The FDA inspection, conducted in July 2025, highlighted several manufacturing control deficiencies at the Reykjavik site. Alvotech’s response letter outlined corrective measures, including process validation and enhanced quality monitoring. The company’s production slowdown is expected to limit supply of its Humira and Stelara biosimilars, which are key revenue drivers, thereby contributing to the revenue miss and the downward revision of guidance. Management emphasized that the facility remains FDA‑approved and that production for the U.S. and other markets will continue, but the corrective timeline introduces uncertainty into near‑term earnings.
Alvotech also announced the appointment of Joseph McClellan as Chief Operating Officer, a move aimed at strengthening operational oversight amid the regulatory challenges. The company confirmed that the Ivers‑Lee acquisition, completed in Q3 2025, has been fully integrated, adding packaging and assembly capabilities in Europe that are expected to support future product launches and improve supply chain resilience.
The company’s pipeline momentum remains robust, with approvals for three new biosimilars in Japan and positive European Medicines Agency opinions for AVT03 and AVT05. These regulatory milestones reinforce Alvotech’s growth prospects in 2026, offsetting short‑term setbacks from the FDA inspection. Management reiterated confidence in its long‑term strategy, citing strong demand for its biosimilar portfolio and the strategic value of the Ivers‑Lee integration.
Investors reacted with caution to the guidance cut and the FDA inspection, reflecting concerns about the temporary production slowdown and its impact on near‑term revenue and profitability. The company’s emphasis on corrective actions and the continued approval of its biosimilar products signals a focus on maintaining market leadership while addressing regulatory compliance.
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