Alvotech Q2 FY2025 earnings call

Management Statement and Operational Highlights

• Product Launches and Market Performance: Humira biosimilar showing strong growth in both European and U.S. markets; STELARA biosimilar performing well in Europe and U.S. uptake progressing as expected.
• Partnerships and Acquisitions: Signed partnerships for early-stage pipeline, acquired Xbrane's R&D operation, a biosimilar candidate to Cimzia, and Ivers-Lee in Switzerland.
• Financial Performance: First half of 2025 revenues up 30% to $306M; product revenues in first half grew over 200% to $205M. Q2 2025 product revenues $95M, licensing revenues $78M. Adjusted product margin 33%, adjusted EBITDA $54M in first half. Cash flow from operations $77M in first half, $59M in Q2.

Segment Performance

• Humira Biosimilar: In Europe, partner with HUKYNDRA has gained market share, now in its fourth year in the market. In the U.S., SIMLANDI launched, reached over 40% share of the U.S. Humira market in July, aiming for 50% by year-end. Partners sell the biosimilar in 33 markets globally, with 67 total marketing approvals.
• STELARA Biosimilar: AVT04 (UZPRUVO) outperforms in Europe, holding first or second market share in key European markets. In the U.S., biosimilar share reached over 20% of the STELARA market in July, on track with internal forecasts.

Guidance

• First half revenue at $306M, roughly 50% of the $600M-$700M guidance. Q3 expected to be soft, with Q4 likely the strongest quarter due to milestone and product revenue dynamics. No guidance change announced; milestones and revenues lumpy with fourth quarter expected to be strong.

Risks

• None explicitly detailed, but general risks related to market competition, regulatory approvals, and revenue lumpiness mentioned in the context of financial results.

Question and Answer

Q: Confidence in top line guidance, Q3 softness, and EBITDA guidance.

A: Linda mentions revenue recognition is lumpy, with Q4 expected to be stronger. Guidance remains intact as first half is in line with expectations.

Q: Growth for SIMLANDI from Quallent channel.

A: Still has a valid contract, but focus is on value rather than volume; business challenging in second half but continues.

Q: FDA inspections and AVT03,05,06 approvals.

A: Inspections are ordinary course of business; will inform market on product approvals going forward.

Q: Revenue and EBITDA guidance, market share for Humira and STELARA.

A: In line with expectations; growth in European markets for Humira and STELARA biosimilars, and U.S. uptake progressing as planned.

Q: BLA approvals slipping to 2026.

A: Targeting BsUFA dates, no slippage expected historically.

Q: Revenue gap and milestones.

A: Fourth quarter expected to be strongest, similar to last year's milestone timing with milestones and product launches driving strong fourth quarter results.