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Alvotech has suspended and terminated its ATM Prospectus Supplement with Jefferies LLC, which had allowed potential open market issuances of its ordinary shares under an Open Market Sale agreement dated June 14, 2024. The underlying Sales Agreement remains in effect, but the company will not sell securities under it unless a new prospectus supplement or a new registration statement is filed.
Alvotech reported Q1 2026 total revenues of $105.9 million, down from $132.8 million a year earlier, with Adjusted EBITDA of $24.4 million and a 57% gross margin. Statutory profit was $1.0 million, helped by finance income, but operating cash flow was a $60.4 million outflow, reducing cash to $63.8 million as of March 31, 2026.
Debt remains high with outstanding borrowings of about $1.31 billion. Management still guides for 2026 revenues of $650–$700 million and Adjusted EBITDA of $180–$220 million, assuming growing biosimilar uptake and new launches. The company concluded it remains a going concern but may need additional financing if cash generation lags.
Strategically, regulators accepted a Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio, with an FDA review period of up to six months. The EMA has also validated a marketing application covering AVT16 and AVT80, and Alvotech expanded commercial agreements and advanced multiple pipeline programs, including Eylea HD and Entyvio biosimilar candidates.
Alvotech filed a Form 6-K highlighting two corporate updates. The company confirmed that all draft resolutions at its 2026 Annual and Extraordinary General Meeting held on June 3, 2026 were approved, with detailed minutes and voting results to be posted on its AGM web portal.
Alvotech also announced resubmission to the U.S. FDA of Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea 2 mg. The resubmissions follow responses to a Post-Application Action Letter and a routine cGMP surveillance inspection at its Reykjavik facility, and the company expects a six-month FDA review. Alvotech already markets five biosimilars globally and has nine disclosed biosimilar candidates in development.
Alvotech reports that the U.S. FDA has completed a routine cGMP surveillance inspection of its Reykjavik, Iceland manufacturing facility, which ended on May 8, 2026 with the issuance of a Form 483. The company believes the observations can be addressed quickly and do not raise substantial issues with the site or its operations.
Alvotech states it is well positioned to resubmit the relevant Biologics License Applications during the current quarter, after final data are compiled, and continues to expect FDA approval for these BLAs during 2026. The company highlights that the inspection outcome supports the strength of cGMP fundamentals and recent site improvements.
Alvotech reported a leadership change, announcing that General Counsel Tanya Zharov has asked to step down after six years with the company. She helped prepare Alvotech for public listings in several jurisdictions and attract international talent to Iceland.
Zharov plans a several-month handover period, continuing to support the company during the transition. She will also take on board responsibilities for Chairman Róbert Wessman’s holding companies, Aztiq and Flóki. Alvotech continues to focus on developing and manufacturing biosimilar medicines, with five biosimilars already approved and marketed in multiple global markets.
Alvotech reported strong 2025 growth with improving profitability and a detailed 2026 outlook. Total revenues reached $593 million, up 21% year-on-year, while adjusted EBITDA rose 27% to $137 million with a 23% margin and gross margin of 61%. The company moved to a net profit of $28 million from a large loss in 2024, supported by higher licensing revenue and favorable non-cash finance items. Cash and cash equivalents were $172 million as of December 31, 2025, and operating cash flow turned positive at $7 million. Several biosimilars, including AVT03, AVT05 and AVT06, were approved in the UK, European Economic Area and Japan, while Selarsdi, referencing Stelara, launched in the United States. For 2026, management guides for total revenues of $650–700 million and adjusted EBITDA of $180–220 million, driven by expansion of commercialized products and efficiency gains, and anticipates late-2026 U.S. approvals for four pending Biologics License Applications.
Alvotech’s major shareholders have updated their ownership report. A group of Aztiq- and ATP-affiliated entities now reports beneficial ownership of 103,849,420 ordinary shares, representing 33.3% of Alvotech’s ordinary share class.
The stake includes 95,213,851 ordinary shares and 8,635,569 earnout shares held by Aztiq Pharma Partners, which carry voting rights and will vest only if the share price reaches at least $20.00 for ten trading days within any twenty-day period before June 15, 2027. ATP entities hold additional shares and warrants. Recent transactions include ATP Holdings purchasing 4,812,257 shares at SEK 44.06 (US$4.74) in connection with a concurrent convertible bond offering, selling 2,110,640 of those shares, and a later private transfer of 2,701,617 shares to Aztiq Pharma Partners at US$4.74 per share.
Alvotech reported positive top-line results from a pivotal pharmacokinetic study of AVT80, its proposed subcutaneous biosimilar to Entyvio (vedolizumab). The randomized, double-blind trial in healthy adults met all primary endpoints for pharmacokinetics, safety, tolerability and immunogenicity after a single 108 mg/0.68 mL injection.
The study is considered pivotal to demonstrate clinical similarity for both AVT80 and AVT16, Alvotech’s subcutaneous and intravenous Entyvio biosimilar candidates, and supports progressing toward regulatory submissions. Entyvio generated about US$6.4 billion in combined worldwide net revenues in 2025, highlighting the commercial potential if these biosimilars are eventually approved.
Alvotech has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, Australia and New Zealand. The collaboration is designed to create commercial pathways for Alvotech’s biosimilar portfolio in these markets ahead of regulatory approvals.
In Canada, the agreement covers one ophthalmology biosimilar candidate supplied as a prefilled syringe for intravitreal injection. In Australia and New Zealand, it covers three biosimilar candidates in immunology and gastroenterology, in multiple formulations. Sandoz will handle regulatory submissions, commercialization and distribution, while Alvotech will manage development, global clinical activities and manufacturing and supply finished product under exclusive supply arrangements.
Alvotech has reached a global licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide for its aflibercept biosimilar to Eylea® 2mg, already approved in the EEA, United Kingdom and Japan.
The deal grants Alvotech worldwide rights to manufacture and supply its commercial partners and sets staged launch dates: marketing and sales from January 1, 2026 in the United Kingdom and Canada, from May 1, 2026 in the European Economic Area and other non‑U.S. countries, and from November 1, 2026 in Japan for all approved indications, alongside a previously announced Q4 2026 license entry date for the U.S., pending regulatory approval.