Alvotech (ALVO) Q1 2026 Earnings Transcript

Motley Fool Transcribing, The Motley Fool

Fri, May 8, 2026 astatine 10:17 AM CDT 24 min read

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DATE

Thursday, May 7, 2026 astatine 8 a.m. ET

CALL PARTICIPANTS

• Executive Chairman — Robert Wessman

• Chief Executive Officer — Lisa Graver

• Chief Financial Officer — Linda Jonsdottir

• Chief Legal and IR Officer — Benedikt Stefansson

Full Conference Call Transcript

Robert Wessman: Good morning, everyone, and convey you for joining us. The archetypal 4th was focused connected 3 priorities, progressing the FDA resubmission, maintaining a precocious level of inspection readiness and continuing to grow our commercialized concern globally, including the motorboat of 3 biosimilars crossed Europe and remainder of the satellite markets. Last week, the FDA began a regular GMP surveillance inspection astatine our Reykjavik facility, which is presently ongoing. Routine surveillance inspection are mean portion of operating an FDA regulated manufacturing installation and our erstwhile surveillance inspection took spot successful 2024. We proceed to prosecute constructively with the bureau passim the process and expect it to beryllium concluded by the extremity of concern time tomorrow.

Since our astir caller pre-license inspection, which took spot successful July 2025, we person implemented respective important enhancements crossed our prime strategy and operations. The enactment to code the findings has been approached successful a highly structured and disciplined mode and is good advanced. Importantly, we person deliberately taken further clip to substantially derisk aboriginal operational and regulatory disruption and to guarantee that erstwhile we resubmit, we bash truthful with a bundle that afloat code the agency's requirements and enactment the semipermanent maturation and worth of the company. These actions person impacted manufacturing throughput, resulting successful a slowdown astatine definite points during 2025 and the archetypal 4th of 2026.

But I'm precise pleased with the advancement the enactment has made and the resubmission of our biologics licence applications for our biosimilars to Simponi, Simponi Eylea, Prolia and Xgeva are present successful the last signifier of completion. As we implicit the existent resubmission process, we judge determination is important near-term worth wrong our pipeline, which we judge is 1 of the astir invaluable successful the manufacture today. We are approaching a fig of important milestones crossed respective high-value programs that volition thrust the company's anticipated beardown maturation successful 2027. This includes submissions successful 2026 of biosimilar to Entyvio and Eylea precocious dose and the resubmission for biosimilar to Eylea, Simponi, Prolia and Xgeva.

These programs people ample and increasing biologics marketplace and presumption america with the archetypal question of biosimilars entrants successful their respective segments. Together with our starring pipeline of 30 biosimilar products, these submissions underscores the spot and the momentum of our pipeline, which volition enactment Alvotech's semipermanent growth. More broadly, we person built retired 1 of the strongest integrated biosimilar level successful the industry, combining probe and development, manufacturing, regulatory capabilities and planetary commercialized partnerships. With the level present built, our absorption has progressively shifted towards execution, launches and converting our pipeline into commercialized growth. Alvotech entered the U.S. marketplace successful mid-2024, marking the modulation from an R&D-focused enactment to a planetary commercialized biosimilar company.