Alvotech (ALVO) Q4 2025 Earnings Transcript

Motley Fool Transcribing, The Motley Fool

Tue, June 2, 2026 astatine 12:17 PM CDT 43 min read

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DATE

Thursday, March 19, 2026 astatine 8 a.m. ET

CALL PARTICIPANTS

• Executive Chairman — Robert Wessman

• Chief Executive Officer — Lisa Graver

• Chief Financial Officer — Linda Jonsdottir

• Chief Scientific Officer — Joseph McClellan

• Head of Investor Relations — Mikaela Vilchez

Full Conference Call Transcript

Robert Wessman: Hello, everyone, and convey you for joining america today. 2025 was an important twelvemonth for Alvotech. We proceed to fortify our presumption arsenic 1 of the starring planetary developers of biosimilars. We expanded our commercialized footprint, precocious respective pipeline programs and strengthened the fiscal presumption of the institution done palmy superior marketplace transactions and our listing connected NASDAQ Stockholm. At the aforesaid time, we person addressed the regulatory reflection of the FDA inspection of our Reykjavik manufacturing facility, and we implemented a broad prime betterment program. Based connected the advancement made truthful far, we expect to resubmit the affected applications to the FDA during the 2nd 4th of 2026.

We will, of course, update the marketplace erstwhile those submissions person been accepted. We person addressed regulatory reflection earlier successful the industry, and we cognize however to lick them. Our absorption has been connected strengthening the operational level truthful that we tin proceed to standard the concern globally going forward. Alvotech has 30 biosimilars successful improvement today. We are advancing plans to person a 2nd root manufacturing tract for immoderate of our cardinal products going forward. This includes manufacturing of cause substance and cause merchandise astatine a strategical CMO spouse based successful the United States. This volition springiness america greater operational flexibility and implicit time, trim operational dependence connected a azygous manufacturing site.

Lisa volition supply much details connected the advancement we are making with this initiative. Stepping backmost for a moment. The semipermanent drivers of the biosimilar marketplace remains precise strong. Across the pharmaceutical industry, we are seeing a continued displacement towards biologic medicines. Today, astir 40% of planetary pharmaceutical income travel from biologics. But if you look astatine the improvement pipeline, this displacement is adjacent much pronounced, astir 60% of Phase II and Phase III pharmaceutical improvement contiguous involves biologics. This tells america that the reliance connected biologics volition lone summation implicit clip arsenic much targeted therapies are developed. At the aforesaid time, much than 100 biologics are expected to suffer patent extortion implicit the adjacent decade.

While healthcare systems astir the satellite are nether expanding unit to trim costs, this creates a precise important accidental for biosimilars. Another important improvement for the manufacture was that FDA draught guidance related to biosimilar development. In practice, it means that ample costly efficacy proceedings volition progressively not beryllium required. Some studies successful the past person costed astir $100 cardinal per programme and added 1 to 2 years to improvement times, reducing that request substantially lowered the improvement outgo connected clip needed to bring biosimilars to market. At Alvotech, we anticipated those changes, and we adopted our improvement strategy already respective years ago.