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The call presented a balanced picture: strong pipeline momentum, rising EBITDA margins, meaningful commercial traction (notably AVT02 market share), a strategic Fujifilm manufacturing partnership and constructive full-year guidance are clear positives. Offsetting these are a material Q1 revenue decline (-20% YoY) and low product margin (11%) driven by deliberate manufacturing slowdowns to address regulatory findings, along with negative operating cash flow, a modest cash balance ($64M) and substantial quarterly interest payments. The company emphasizes derisking for stronger 2027 growth, but near-term financial and regulatory execution risks remain.
The company reiterated full‑year 2026 guidance of $650–700 million in revenues and $180–220 million of adjusted EBITDA, said Q4 2026 is expected to be the strongest quarter and reiterated the goal of positive free cash flow in Q4 2026, and flagged 2027 as a year of strong year‑on‑year growth with the potential for “healthy leverage.” Q1 2026 provided context for that outlook: total revenues $106M (‑20% YoY), product revenues $51M, licensing $55M, adjusted EBITDA $24M (23% margin), gross margin 57% and product margin 11%; cash at quarter‑end was $64M, operating cash flow was ‑$25M, net interest ≈$35M/quarter, CapEx $7M and intangibles investment $39M. Key operational guidance: resubmissions of BLAs slated after the ongoing FDA inspection (resubmission timing in Q2 with a target approval timeline into Q4), submissions for Entyvio and high‑dose Eylea planned in 2026, and added U.S. manufacturing supply from Fujifilm expected to begin in H2 2027.
Resubmissions of BLAs for biosimilars to Simponi, Eylea (high-dose and low-dose), Prolia and Xgeva are in the final stage of completion; EMA marketing authorization application submitted for AVT16 and AVT80 (Entyvio); AVT29 (high-dose Eylea) on track for EMA submission in 2026 and first patients enrolled in pivotal study supporting a 2028 U.S. submission.
AVT02 (Humira biosimilar) became the fastest-growing Humira biosimilar in the U.S., achieving ~10% market share; commercial presence expanded to over 90 countries; newly approved products (AVT03, AVT05, AVT06) began contributing incremental revenues in Europe, U.K. and Japan.
Signed strategic manufacturing agreement with Fujifilm Biotechnologies to diversify capacity and add U.S.-based supply; technology transfer initiated with product supply to the U.S. expected to begin in H2 2027, supporting future launches and supply resilience.
Adjusted EBITDA was $24 million in Q1 2026, up from $21 million in Q1 2025 (≈+14%), with EBITDA margin improving to 23% from 15% a year earlier (an improvement of 8 percentage points).
Reported gross margin of 57% for Q1 2026, a modest improvement of 6 basis points versus the same period last year, reflecting a balanced mix of product and licensing revenues.
Full-year 2026 revenue guidance of $650–$700 million (targeting continued double-digit growth vs. 2025) and adjusted EBITDA guidance of $180–$220 million; company expects stronger manufacturing output and material margin improvement entering 2027.
Good day and thank you for standing by. Welcome to the Alvotech First Quarter 2026 Earnings Conference Call. [Operator Instructions] Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Benedikt Stefansson, Vice President of Investor Relations. Please go ahead.
Thank you, and welcome to our listeners. Yesterday evening, the company issued a press release announcing our financial results for the first quarter of 2026. Material accompanying today's earnings call, including a supplemental earnings report, providing additional operational details and business updates and the presentation we'll be referring to on today's call were also published on our investor portal, investors.alvotech.com, in the Earnings Calendar section under the heading Q1 2026 Earnings Call. Our press release, earnings report, presentation and statements that we make on the call today may include forward-looking statements. These statements do not ensure future performance and are subject to risks and uncertainties that are outlined in company filings with the Securities and Exchange Commission. Any risks and uncertainties could cause actual results to differ materially from forward-looking statements that are made. Presenting on today's call are Robert Wessman, Founder and Executive Chairman; Lisa Graver, Chief Executive Officer; and Linda Jonsdottir, Chief Financial Officer. Robert will begin today's presentation with a summary of our progress with the U.S.
regulatory pathway and some key business highlights. Lisa will then present a commercial an...