Alvotech Q4 FY2023 earnings call

• Alvotech cleared U.S. FDA inspection, enabling access to the U.S. market, with SIMLANDI approved and STELARA biosimilar set for FDA approval next month. • 2023 laid foundation for growth with global regulatory approvals, commercial network expansion via partnerships, and pipeline advancement with positive clinical results for multiple programs. • 2024 seen as transformational with major product launches in large markets, including SIMLANDI in U.S. Q2, STELARA biosimilar in Canada, Japan, and Europe, and preparations for AVT04 launch in U.S.

In 2023, total revenues were $93.3 million, an increase of around 10% from the prior year. Product revenues were $48.7 million, almost doubling from the prior year, driven by launch timings. Milestone revenues were $42.7 million, largely from the AVT06 program's clinical results.

• Forecasts 2024 revenues between $300 million and $400 million, a 3-4x year-on-year growth from 2023. • Adjusted EBITDA forecast in range of $50 million to $150 million for 2024. • Anticipates multiple product launches in 2024, including SIMLANDI in U.S. Q2, STELARA biosimilar in Japan Q2 and Europe Q3, and preparations for AVT04 U.S. launch. • Expects at least three additional submissions in major markets in 2024 and commencement of AVT16 clinical trial. • Milestone revenue could range up to 40%-50% of total revenues in 2024.

Q: Could you summarize key milestone-based events in 2Q and how to think about gross margins?

A: Joel Morales mentioned milestones driven by submissions, BLA filings, clinical completions, and key launches. Regarding COGS, revenue is recognized when product is shipped, and COGS is recognized at the same time.

Q: What are expectations for HUMIRA in U.S. market and 2-tier pricing strategy?

A: Anil Okay stated partner is in active discussions with payers, expecting broad formulary access, and details of 2-tier pricing will be public soon with launch in Q2.

Q: Confidence in AVT04 FDA approval by April 16 and KEYTRUDA biosimilar?

A: Ming Li said high confidence in AVT04 approval as inspection status is clear, and Anil Okay noted Alvotech has in-house technology to handle potential process changes for KEYTRUDA.

Q: Timeline of inclusion on formularies for HUMIRA in U.S. and EYLEA biosimilar approval?

A: Anil Okay expects HUMIRA to be on formularies by July 1, and EYLEA biosimilar filing in 2024 with approval before LOE in 2025.

Q: Clarity on adjusted EBITDA guidance and cost development?

A: Joel Morales explained revenue from product sales and milestones, with EBITDA range driven by combination of events including launches and milestones, and more details to come as business matures.

Q: Sales split between AVT04 and AVT02 in 2024 and split between milestone and product sales revenue?

A: Joel Morales stated not offering detailed split at this time, and milestone revenue could be 40%-50% of total revenues in 2024.