Alvotech Q1 2026 Financial Results
Rhea-AI Summary
Alvotech (NASDAQ: ALVO) reported Q1 2026 revenue of $105.9m versus $132.8m year-ago and adjusted EBITDA $24.4m with gross margin 57%. Management said production slowdowns for facility improvements reduced near-term volumes. Post-period, Alvotech filed EMA applications for AVT16 and AVT80, started a pivotal AVT29 study for high-dose Eylea HD, and signed a U.S. manufacturing agreement with FUJIFILM Biotechnologies. 2026 guidance: revenues $650–700m and adjusted EBITDA $180–220m.
Positive
- EMA marketing submissions filed for AVT16 and AVT80
- Pivotal AVT29 study for Eylea HD commenced
- Strategic manufacturing agreement with FUJIFILM Biotechnologies
- 2026 guidance: $650–700m revenue and $180–220m adjusted EBITDA
Negative
- Q1 revenue declined to $105.9m from $132.8m year-ago
- Production slowdown for facility improvements reduced quarterly volumes
- Resubmission timing to FDA delayed to second quarter, adding near-term uncertainty
- Revenue guidance low-end assumes no U.S. new launches in 2026
Key Figures
Market Reality Check
Peers on Argus
ALVO slipped -0.57% while key peers were mixed: SUPN +1.6%, INDV +2.09%, HCM +1.28%, BHC -0.7%, ANIP -1.15%, pointing to stock-specific rather than sector-wide pressure.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 18 | Q4/FY 2025 results | Positive | -5.8% | Strong Q4 and FY 2025 growth with reaffirmed 2026 revenue and EBITDA guidance. |
| Nov 04 | Conference participation | Neutral | -4.0% | Participation in Morgan Stanley healthcare conference and investor meetings. |
| May 08 | Regulatory/pipeline update | Positive | +18.1% | MHRA acceptance of marketing application for AVT23 Xolair biosimilar candidate. |
| May 07 | Q1 2025 results | Positive | +18.1% | Strong Q1 2025 revenues, sharply higher product sales and raised full-year guidance. |
| May 05 | Acquisition/R&D expansion | Positive | -4.3% | Acquisition of Xbrane R&D operations and biosimilar candidate XB003 in Sweden. |
Earnings and major updates often produced sizable moves, with several positive-news events followed by strong gains but also instances of negative reactions despite upbeat fundamentals and guidance.
Over the last year, Alvotech has combined rapid revenue growth with expanding its biosimilar portfolio and strategic transactions. Q4 2025 results on Mar 18, 2026 showed revenues of $173M and FY 2025 revenues of $593M, with adjusted EBITDA of $69M in Q4 and $137M for the year, plus reiterated 2026 guidance of $650–700M revenue and $180–220M adjusted EBITDA. Earlier 2025 updates around Q1 2025 results, product filings, approvals, and the Xbrane acquisition also triggered double‑digit moves, underscoring the sensitivity of the stock to earnings and pipeline news.
Historical Comparison
In the past, ALVO earnings-related headlines led to average moves of about 4.44%, with both strong rallies and occasional negative reactions to otherwise positive updates.
Earnings releases show a trajectory from rapid revenue growth and improving EBITDA toward reiterated 2026 guidance of $650–700M revenue and $180–220M adjusted EBITDA, while expanding the biosimilar pipeline and commercial footprint.
Market Pulse Summary
This announcement details Q1 2026 results, with total revenues of $105.9M, adjusted EBITDA of $24.4M, and a 57% gross margin, alongside continued execution on FDA resubmissions and manufacturing upgrades. Management reiterates 2026 guidance of $650–700M in revenue and $180–220M in adjusted EBITDA and highlights pipeline progress, including EMA submissions and a pivotal study for Eylea HD. Investors may track regulatory outcomes, production normalization, and delivery against these guidance ranges in upcoming quarters.
Key Terms
form 6-k regulatory
marketing authorization application regulatory
european medicines agency regulatory
biosimilars medical
pivotal efficacy and safety study medical
adjusted ebidda financial
gross margin financial
marketing authorization regulatory
AI-generated analysis. Not financial advice.
Alvotech (NASDAQ US: 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 of57%
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
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, please contact:
Media – alvotech.media@alvotech.com
Benedikt Stefansson
Sarah MacLeod
Investors - alvotech.ir@alvotech.com
Dr. Balaji V Prasad
Benedikt Stefansson
The information was submitted for publication through the agency of the contact persons.
Financial calendar:
Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change.
| Quarter | Date of release | Date of earnings call |
| Q2 2026 | August 19, 2026 | August 20, 2026 |
| Q3 2026 | November 11, 2026 | November 12, 2026 |
| Q4 2026 | March 10, 2027 | March 11, 2027 |
About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.
For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.
Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.
Non IFRS Financial Measures
This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.
1 Figures are adjusted to exclude items that are not indicative of our ongoing operating performance. See disclaimer on ‘Non IFRS Financial Measures’ at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or file quarterly financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update.
