Alvotech (NASDAQ:ALVO, ICELAND: ALVO, STOCKHOLM: ALVO SDB))
Financial Highlights
A supplemental long‑form earnings release providing additional operational details and business update for Q1 2026 is available at: https://investors.alvotech.com/earnings-calendar under "Q1 2026 Earnings Call". The supplemental document is provided solely for reference and is not part of this SEC Form 6‑K. The Form 6‑K should not be read together with, or construed as referring to, the supplemental long‑form release.
Q1 2026 Highlights
Total revenues1 were $105.9m compared to $132.8m in the same period last year
Adjusted EBITDA1 was $24.4m with Gross Margin of 57%Post-period end:
Submitted a Marketing Authorization Application to the European Medicines Agency for AVT16 and AVT80, proposed biosimilars to Entyvio® (vedolizumab)
Commenced a pivotal efficacy and safety study for AVT29 for Eylea HD® in support of a submission in the US in 2028
Entered into a strategic manufacturing agreement with FUJIFILM Biotechnologies, establishing a U.S.-based second source of commercial supply
Comments by Lisa Graver, CEO:
"During the quarter, we continued to execute across multiple strategic priorities, including progressing the FDA resubmission process, expanding our commercial portfolio, advancing high-value pipeline programmes, and further strengthening our manufacturing platform.
"In recent months, we have implemented several important improvements across our quality systems and operations. Importantly, we have deliberately taken additional time to substantially de-risk future operational and regulatory disruption and to ensure that when we resubmit to the FDA, we do so with a package that fully addresses the agency's requirements and supports the long-term growth and value of the company.
"Both revenues and EBITDA were impacted in the quarter by a slowdown in production related to these facility improvements. We expect a recovery in product revenues as normal operations resume.
"Commercially, we continue to see strong underlying demand for biosimilars across our marketed portfolio, including continued momentum for our Humira biosimilar in the U.S. market.
"At the same time, we advanced several important pipeline programmes, including a marketing submission to the European Medicines Agency for our proposed biosimilar to Entyvio, and continued progress with our programme for high-dose Eylea, where the first patients have now been enrolled in a pivotal clinical study.
"In addition, we have today announced a strategic manufacturing agreement with FUJIFILM Biotechnologies covering multiple products in our portfolio. This is an important step to further strengthen and diversify our manufacturing network that supports the next phase of commercial launches.
"We remain highly focused on resubmitting our BLAs pending approval with the U.S. FDA in the second quarter. Actions taken since last year strengthen not only the packages for resubmission but also our operational platform more broadly, supporting future pipeline execution. With these improvements, we believe the company is well positioned for its next phase of growth."
Outlook for 2026
Management anticipates total revenues to be in the range of $650-$700 million and adjusted EBITDA to be in the range of $180-220 million in 2026. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026.
Invitation to Q1 2026 management presentation:
Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, May 7, 2026.
The audio webcast will be accessible via the following link: https://edge.media-server.com/mmc/p/ppckxq33
To participate via telephone in the Q&A session, please register using this link to obtain your PIN: https://register-conf.media-server.com/register/BIdfe56c21c8d448efb09f3c30405bb00d
Presentation slides for the webcast and other materials are available under "Q1 2026 Earnings Call" at: https://investors.alvotech.com/earnings-calendar
For further information, ...
