Alvotech Q1 FY2025 earnings call

• Alvotech decided to list SDRs on Nasdaq Stockholm Market, with trading expected to begin on May 19. - Revised 2025 top line revenue guidance to $600 million to $700 million and adjusted EBITDA guidance to $200 million to $280 million. - Fourth consecutive quarter of positive adjusted EBITDA and operating profits, with triple-digit increases in product and total revenues. - Stelara biosimilar launched in the U.S. in late February, with strong market share in European markets. - Three biosimilar filings under review, with AVT23's marketing application accepted by the U.K. regulator and expected launch in early 2026. - Vertical integrated development and manufacturing approach, with 20 strategic commercial partnerships across 90 markets. - Potential U.S. tariffs on pharmaceuticals expected to not be disruptive in 2025 as partners are responsible for customs clearance and duties.

In the first quarter, Alvotech delivered $110 million in product revenues, a $97 million or 784% increase compared to the same period prior year. Adjusted product margin was 41% in Q1, expected to be in the mid-30% range in the first half and 38% to 41% for the full year. Adjusted licensing and other revenue was $23 million, with milestone revenues expected to increase, particularly in the second half of the year. The company achieved positive adjusted EBITDA of $21 million for Q1 2025, versus negative adjusted EBITDA of $38 million in the same period prior year.

• Raised 2025 top line revenue to $600 million to $700 million and adjusted EBITDA to $200 million to $280 million. - Expect to be free cash flow positive in 2025, being self-funded for the first time. - Milestone revenues expected to continue increasing, with approximately 75% of full-year milestone revenues recognized in the second half of 2025. - Three new biosimilar approvals and launches expected in Q4 2025, with AVT23 launching in early 2026.

• Potential U.S. tariffs on pharmaceuticals: Still being reviewed, but pharma imports to U.S. remain duty free, and partners are responsible for customs clearance and duties, so expected not disruptive to Alvotech or customers in 2025.

Q: Clarify the interchangeable exclusivity for the Stelara biosimilar and when PBMs may drop the brand from their plans.

A: Alvotech got interchangeability designation on April 30, with competition expected to get interchangeable designations, but this is positive for faster uptake. There are active sales dialogues for private label partners, and PBMs are expected to exclude the originator from formularies, opening opportunities for biosimilars.

Q: Quantify the buyout of stocking for the Stelara biosimilar in the first quarter given $110 million net product sales.

A: Alvotech is a B2B business, driven by purchase orders, not stocking, with lumpiness in shipments based on commercial partners' dynamics.