Alvotech (NASDAQ:ALVO) said its first-half 2026 results reflected a temporary manufacturing slowdown tied to facility and quality-system improvements at its Reykjavik site, while management reaffirmed full-year revenue and adjusted EBITDA guidance and highlighted upcoming regulatory decisions and product launches.
The company reported first-half revenue of $212 million, down from $306 million a year earlier, as manufacturing output was constrained during work to address FDA inspection observations and prepare resubmissions for several biologics license applications. Adjusted EBITDA was reported at $47 million for the first six months, compared with $54 million in the prior-year period, while gross margin was 54%, versus 55% a year earlier.
Manufacturing returned to planned operating levels near the end of the second quarter, and the company is now working to rebuild supply for customers. CFO Linda Jónsdóttir said Alvotech expects the fourth quarter to be its strongest period of 2026, with product revenue gaining momentum in the third quarter and a larger step-up expected in the fourth quarter.
Guidance Reaffirmed as Financing Bolsters Liquidity
Alvotech reaffirmed its 2026 guidance for total revenue of $650 million to $700 million and adjusted EBITDA of $180 million to $220 million. Management said the outlook assumes a strong fourth quarter, supported by increased manufacturing output, product shipments and milestone revenue.
First-half product revenue was $106 million, while licensing revenue also totaled $106 million. Jónsdóttir said licensing and milestone revenue can be uneven because it depends on development progress, regulatory submissions and contractual events.
The company ended June with $143 million in cash. During the quarter, Alvotech completed an equity offering that generated approximately $165 million in gross proceeds. The company also secured an additional term loan facility of up to $75 million from existing lenders, which it said was drawn in the third quarter and therefore was not included in the June cash balance.
Management said the equity and debt financing together provided approximately $240 million of new capital to support pipeline investment, manufacturing and supply needs, launch preparations and global commercialization. Jónsdóttir added that the company expects “healthy de-leveraging” in 2027.
FDA Inspection Closed; BLA Reviews Underway
Founder and Executive Chairman Róbert Wessman said the company’s investments in its manufacturing facility and quality systems enabled it to resubmit U.S. BLAs in June. The FDA subsequently closed its May 2026 routine GMP surveillance inspection of the Reykjavik facility with a Voluntary Action Indicated, or VAI, classification in July.
Chief Operating Officer Joseph McClellan said the FDA acknowledged the resubmissions as complete responses to prior action letters and assigned review completion dates consistent with a standard six-month review process. The applications cover proposed biosimilars to Simponi Aria, EYLEA and the dual Prolia/Xgeva products.
Graver said the resubmissions position the company for potential FDA approvals in the fourth quarter of 2026. In particular, she said Alvotech expects to be first or among the first biosimilars approved for Simponi and Simponi Aria in the U.S.
Regarding Simponi-related litigation, Graver said Alvotech expects a decision during the fourth quarter and said the company believes it has a strong intellectual-property position. She did not provide a precise U.S. launch date, noting that the company commercializes through partners.
Commercial Portfolio Expands to Five Products
Management said Alvotech now has five biosimilars contributing to product revenue, expanding beyond its biosimilars to Humira and Stelara. Its biosimilars to Simponi, EYLEA, and Prolia/Xgeva have begun contributing to sales.
In the U.S. adalimumab market, Graver said biosimilars now account for more than 60% of the market. SIMLANDI holds the No. 2 biosimilar position, she said, while the company’s European adalimumab product Hukyndra has continued to see demand four years after its launch.
For ustekinumab, U.S. biosimilar penetration has reached roughly 60%, according to Graver. She said SELARSDI is participating in the expanding market, while European product Uzpruvo remains positioned in an established biosimilar market.
AVT05 and AVT06 have launched in more than 10 European markets, including Germany, France, the U.K., Spain and Italy. Graver said AVT05 has shown encouraging early momentum in Germany and Spain and launched in Japan in July as the country’s only approved golimumab biosimilar. AVT06 also launched in Japan earlier this year and has seen what management described as strong early uptake.
Pipeline Includes Entyvio, Keytruda and EYLEA HD Programs
McClellan said Alvotech has more than 30 biosimilar candidates in development. The company expects its next wave of products to receive approvals during 2027 through 2029, including proposed biosimilars to Keytruda, Entyvio and EYLEA HD.
Alvotech and Dr. Reddy’s have begun a randomized, double-blind pharmacokinetic similarity study of their proposed Keytruda biosimilar in participants with melanoma. For Entyvio, the company’s European marketing authorization application for intravenous AVT16 and high-concentration subcutaneous AVT80 has been validated. The FDA has accepted AVT16’s BLA, and management said it expects to announce a U.S. AVT80 submission soon. Decisions are expected in 2027.
For AVT29, Alvotech’s proposed EYLEA HD biosimilar, the company plans its first regulatory submission in Europe during 2026. Its U.S. clinical study is underway, with a U.S. submission anticipated in 2028.
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).
