Alvotech (NASDAQ:ALVO) executives used the company’s fourth-quarter and full-year 2025 earnings call to outline progress on commercial launches, manufacturing and quality initiatives tied to recent U.S. regulatory setbacks, and a 2026 outlook that assumes continued growth outside the United States.
2025 highlights and leadership transition
Founder and Executive Chairman Róbert Wessman said 2025 strengthened Alvotech’s position “as one of the leading global developers of biosimilars,” pointing to an expanded commercial footprint, pipeline advancement, capital markets activity, and a Nasdaq Stockholm listing. Management also emphasized a “comprehensive quality improvement program” implemented after an FDA inspection of the Reykjavik manufacturing facility.
Regulatory update: CRLs tied to Reykjavik inspection
Chief Operating Officer Joseph E. McClellan said Alvotech had four active U.S. biologics license applications (BLAs) for proposed biosimilars to Simponi Aria, Prolia, and Xgeva, and received complete response letters (CRLs) in the fourth quarter of 2025. He said the CRLs were linked to items identified following the FDA’s July 2025 inspection of the Reykjavik facility, and that the FDA did not raise issues with the analytical, pharmacokinetic, or clinical efficacy and safety data in the applications, which were “considered complete.”
McClellan said the company implemented most corrective actions by the end of 2025 and is now focused on demonstrating that improvements are “effective and sustainable over time” before resubmission. Based on current progress, he said the company remains on track to resubmit in the second quarter of 2026, which “would position us for FDA decisions before the end of the year.” In the Q&A, he added the company is working to submit by the end of the first quarter but is prepared that it could slip into the second quarter, while still targeting the first half of the year.
McClellan also noted that the Reykjavik facility “remains an FDA-approved manufacturing site,” and that Alvotech continues to manufacture on-market products for the U.S. and other markets. He said there is an opportunity for the FDA to inspect again, though Alvotech is aiming to submit a comprehensive response that could potentially avoid another inspection.
Commercial execution and portfolio update
Graver said the company’s near-term priority is completing the FDA-related improvement plan “to ensure we receive FDA approval for all pending applications for AVT03, AVT05, and AVT06 this year,” while continuing to commercialize products in the U.S. and launching AVT03, AVT05, and AVT06 outside the U.S.
On commercial milestones in 2025, Graver said partner Teva launched Selarsdi in the U.S., which she described as Alvotech’s second U.S. biosimilar launch. She also cited approvals and first launches for Golimumab, Denosumab, and Aflibercept across Europe, the U.K., and Japan. The company also signed partnership agreements with Advanz Pharma (including the Cimzia program) and Dr. Reddy’s (for the Keytruda program), and added Sandoz as a commercial partner.
Among product-level updates discussed:
- Humira (AVT-02/SIMLANDI): Graver said the originator’s U.S. share declined from roughly 70% at the beginning of 2025 to around 45% by year-end. She said SIMLANDI holds approximately 9% U.S. share and was the “second-largest and one of the fastest-growing” biosimilars in the segment.
- Stelara (AVT-04): Graver said biosimilars account for about 40% of the U.S. market and that Teva continues expanding formulary coverage for Selarsdi. In Europe, she said Uzpruvo holds more than 20% share of the biosimilar segment.
- Simponi (AVT-05): Graver said AVT-05 faces limited competition in markets where it has been approved and expects first-to-market positioning in several regions. She said AVT-05 was first approved by both the EMA and MHRA and is being marketed as Gobivaz via Advanz Pharma, including launch activities after a U.K. NHS tender award. In Japan, she said it is the first and only approved biosimilar to Simponi and that Fuji Pharma announced a May 2026 market entry date. She added the company expects a Canadian decision in the first half of 2026.
- Aflibercept (AVT-06): Graver said Alvotech signed a licensing and settlement agreement resolving patent disputes related to Aflibercept 2 mg worldwide, providing “clear pathways” for market entry. She said the U.S. has a licensed entry date in the fourth quarter of 2026 or earlier under certain circumstances, pending FDA approval. She also said Fuji Pharma launched AVT-06 in Japan in February with “strong early demand.”
- Denosumab (AVT-03): Graver said AVT-03 was approved in Europe in November 2025 and launched in Germany and select European markets through partners Stada and Dr. Reddy’s Laboratories, with competitive early pricing dynamics, particularly in tender-driven segments. In Japan, she said AVT-03 remains the first and only approved biosimilar, with Fuji Pharma preparing for a 2026 market entry.
Pipeline progress and FDA biosimilar guidance
Management repeatedly emphasized scale in development. Wessman said Alvotech can initiate a new biosimilar program “roughly every two months” and has 30 biosimilars in development representing more than $185 billion in global sales. McClellan said selection criteria focus on market opportunity, durable mechanisms of action, high barriers to entry, and opportunities where Alvotech’s integrated platform can differentiate.
McClellan highlighted progress on a biosimilar to Entyvio, citing positive top-line results from a pivotal pharmacokinetic study and plans to submit regulatory applications later in 2026. He said Alvotech anticipates being among the first to launch an Entyvio biosimilar, including both intravenous and subcutaneous presentations. He also discussed the Keytruda biosimilar program with Dr. Reddy’s, noting Keytruda annual sales exceeding $30 billion and that the collaboration involves sharing development costs and marketing rights. He said the company anticipates submitting a therapeutic pharmacokinetic study and is on track to submit a marketing application in 2028.
McClellan also addressed recent FDA draft guidance he said reduces the need for large comparative efficacy and safety trials and may allow two-arm pharmacokinetic studies in many cases, with increased flexibility in reference product selection. He said Alvotech had already aligned development strategies with regulators and believes it is positioned to benefit from streamlined pathways.
Financial results and 2026 outlook
Chief Financial Officer Linda Jónsdóttir said fourth-quarter performance “landed within our guidance,” driven primarily by licensing revenues. She reported Q4 2025 total revenue of $173 million, up 13% year-over-year, with licensing revenues comprising 75% of the total. She said gross margin was 66% and adjusted EBITDA was $69 million, representing a 40% margin. Product revenue was $43 million, and product margin was negative 37%, which she attributed to timing of orders and planned facility upgrades that lowered throughput in the second half of 2025.
For the full year 2025, Jónsdóttir reported total revenue of $593 million, up 21%, with the mix split evenly between product and licensing revenues. She reported gross margin of 61% and adjusted EBITDA of $137 million, up 27%, representing a 23% margin. She also said operating cash flow for the year was positive for the first time at $7 million, while Q4 operating cash flow was negative $28 million, impacted by lower collections tied to softer product revenues and inventory build.
Jónsdóttir said year-end cash was $172 million, supported by fourth-quarter financing including $108 million in convertible bonds and a $100 million senior term loan. She said the company’s leverage ratio (net debt to adjusted EBITDA) declined to 9.3x and is expected to improve meaningfully in 2026.
Looking ahead, Alvotech reaffirmed 2026 guidance for revenue of $650 million to $700 million and adjusted EBITDA of $180 million to $220 million. Jónsdóttir said the low end assumes no U.S. launches in 2026. In the Q&A, management said the upper end reflects efforts to grow supply revenues, with visibility described as good over the next six months, while also noting quarterly lumpiness tied to milestone timing and shipment patterns.
About Alvotech (NASDAQ:ALVO)
Alvotech (NASDAQ:ALVO) is a global biopharmaceutical company specializing in the development, manufacturing and commercialization of biosimilar medicines. The company focuses on creating high‐quality, cost‐effective alternatives to established biologic therapies in areas such as immunology, oncology and other specialty care fields. By leveraging in‐house research and a vertically integrated manufacturing platform, Alvotech aims to bring approved biosimilars to market more rapidly and with greater cost efficiency than many traditional biosimilar developers.
Since its founding in 2013, Alvotech has built a diversified pipeline of monoclonal antibody biosimilars, targeting blockbuster reference products including adalimumab (originally branded Humira), bevacizumab (Avastin) and ustekinumab (Stelara).
