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FDA inspection at Alvotech’s Reykjavik facility is underway and Biologics License Application resubmissions for multiple biosimilars are in the final stage, with the company planning resubmissions in Q2 and targeting Q4 approvals.
Facility quality improvements have reduced manufacturing throughput, and Alvotech signed a deal with Fujifilm to add U.S. capacity; technology transfer is underway with product supply to the U.S. expected in the second half of 2027.
Commercially, AVT02 (Humira biosimilar) is the fastest-growing U.S. Humira biosimilar at about 10% of the biosimilar segment, while Q1 revenue fell 20% to $106 million; management reaffirmed full-year revenue guidance of $650–$700M and adjusted EBITDA guidance of $180–$220M.
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Alvotech (NASDAQ:ALVO) executives said the company’s first-quarter priorities centered on advancing U.S. regulatory work, maintaining inspection readiness, and expanding commercial activity globally as the biosimilar developer works through manufacturing enhancements at its Reykjavik facility.
Founder and Executive Chairman Róbert Wessman said the company spent the quarter “progressing the FDA resubmission, maintaining a high level of inspection readiness, and continuing to expand our commercial business globally.” He noted the U.S. Food and Drug Administration began a “routine GMP surveillance inspection” at Alvotech’s Reykjavik facility last week, with the inspection “currently ongoing.” Wessman said the company expects it to conclude “by the end of business day tomorrow,” adding that routine surveillance inspections are a normal part of operating an FDA-regulated manufacturing site.
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Wessman also referenced steps taken since the company’s most recent pre-license inspection in July 2025. He said Alvotech has implemented “important enhancements across our quality system and the operations,” and that work to address findings is “well advanced.” He added the company “deliberately taken additional time to substantially de-risk future operational and regulatory disruption” and to ensure its resubmissions “fully address the Agency’s requirements.”
According to Wessman, the resubmission of Biologics License Applications for biosimilars to Simponi, SIMPONI ARIA, EYLEA, Prolia, and XGEVA is “now in the final stage of completion.” During Q&A, Chief Executive Officer Lisa Graver said the FDA is “on site” and that Alvotech expects the surveillance inspection to close out this week. Graver said the company is “on track” to resubmit the pending BLAs in the second quarter and that the “target is still and does remain the fourth quarter” for approvals.
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Both Wessman and Graver said facility improvements have weighed on production. Wessman said the actions taken to address inspection findings “impacted manufacturing throughput,” contributing to a slowdown at points during 2025 and in the first quarter of 2026.
Graver said Alvotech is also exploring additional capacity “especially in the United States,” and highlighted a newly announced manufacturing agreement with Fujifilm Biotechnologies covering multiple products. She called the agreement “an important strategic step in further strengthening and diversifying our global manufacturing network, including expanded U.S.-based manufacturing capability.”
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Graver said the company is initiating technology transfer activities and expects to begin supplying products for the U.S. market “in the second half of 2027” as the transfer and qualification process progresses. In response to an analyst question about how much U.S. supply could come from Fujifilm, Graver said it is “too early to say,” while emphasizing that the Reykjavik site will “continue to be a predominant player across the markets.”
Graver said the company is seeing “solid underlying demand trends” and broader adoption of biosimilars. For AVT02, Alvotech’s biosimilar to Humira, she said available market data show it has become “the fastest-growing biosimilar to Humira in the United States” and has reached a 10% market share within the biosimilar segment.
During Q&A, Graver attributed the U.S. momentum in part to the “continued erosion of the Humira product” and an expanding biosimilar share of the market. She said Alvotech is seeing “an exit share of 60% of the market being biosimilar in the U.S. now,” and credited partner Teva’s commercial execution.
For AVT04, Alvotech’s biosimilar to Stelara, Graver said Teva continues to expand the product’s market in the U.S., while in Europe the product “continues to hold a leading share of the biosimilar segment in launched markets.” Addressing questions about Europe, she said the ustekinumab biosimilar market has shown “somewhat of a flattening in Q1,” but added she is not prepared to call that a full-year trend. She said biosimilar penetration is “about 56%” in Europe and noted continued growth in Germany.
Graver also said partners are progressing launches for Alvotech’s biosimilars to Simponi, Eylea, Prolia, and XGEVA, which received approvals in Europe, the U.K., and Japan late last year. She highlighted AVT05 (Simponi) as “the only biosimilar for the predominant presentation in the market,” and said the set of launches helps diversify the company’s commercial portfolio.
On the pipeline, Graver said Alvotech submitted marketing authorization applications to the European Medicines Agency for AVT16 and AVT80, proposed biosimilars to Entyvio. She cited Entyvio sales in Europe “close to $2 billion and growing” and said the company believes it is positioned to be “within the first wave, if not the first biosimilar for this product.”
Graver also discussed AVT29, the company’s proposed biosimilar to high-dose Eylea. She said Alvotech is on track to submit an EMA application in 2026, and that the company has enrolled the first patients in a pivotal efficacy and safety study supporting a U.S. submission planned for 2028. Graver put the combined low-dose and high-dose Eylea market at approximately $8 billion, with $5 billion in the U.S. and $3 billion in Europe.
Chief Financial Officer Linda Jónsdóttir said total revenue in the first quarter was $106 million, a 20% decline from the prior-year quarter. She attributed the impact to facility improvements and the associated slowdown, adding that the company expects Q4 2026 to be “the strongest quarter of the year.”
Jónsdóttir reported gross margin of 57% and said revenues were “equally split” between product and licensing revenue in the quarter. She said product margin was 11%, and noted that margins in the second half of 2025 and Q1 2026 were impacted by reduced manufacturing throughput. As manufacturing normalizes and volumes recover, she said the company expects to enter 2027 with a “stronger margin profile.”
Adjusted EBITDA was $24 million, representing a 23% margin, compared with $21 million and a 15% margin in Q1 2025. Jónsdóttir also said changes in regulatory guidance from the FDA and EMA, including circumstances where comparable clinical studies can be waived, have shifted emphasis toward analytical similarity. She said this allows certain development programs to meet capitalization criteria earlier under IAS 38, increasing the proportion of development costs capitalized beginning in 2026.
On revenue composition, Jónsdóttir said product revenue was $51 million, driven primarily by AVT02 (Humira) and AVT04 (Stelara), with incremental contributions from newly approved products AVT03 (Prolia/XGEVA), AVT05 (Simponi), and AVT06 (Eylea) as launches expanded across Europe, the U.K., and Japan. Licensing revenue was $55 million, which she described as “inherently lumpy” due to milestone timing. Graver added during Q&A that quarter-to-quarter variability in product revenue is largely due to “customer order pattern and invoicing,” not pricing.
Jónsdóttir said cash on hand at quarter-end was $64 million. Operating cash flow was negative $25 million, driven mostly by working capital, and the company paid net interest of $35 million in the quarter following a mid-2025 transition from PIK to cash interest. She reported CapEx of $7 million and “investment in accountables” of $39 million, and said management remains focused on achieving positive free cash flow in Q4 2026.
For the full year, Jónsdóttir reaffirmed revenue guidance of $650 million to $700 million and adjusted EBITDA guidance of $180 million to $220 million. She noted the low end of the revenue range does not include U.S. revenues from approvals and launches of AVT03, AVT05, or AVT06. Looking to 2027, she said Alvotech expects strong year-over-year growth supported by portfolio expansion, pipeline milestones, and improving manufacturing output after facility improvements.
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).
The article "Alvotech Q1 Earnings Call Highlights" was originally published by MarketBeat.