Alvotech Q3 FY2024 earnings call

• FDA Inspection: Concluded an extensive general GMP inspection in September, received two observations but viewed as a success, with plans for future FDA general GMP inspections on a two-year cadence.
• Pipeline Progress: AVT16 in patient trials; EMA acceptance for AVT03 and AVT05; approval for additional presentation of SELARSDI in the US, with launch in 2025 in the US market with all indications.
• Commercial Updates: AVT02 launched in 26 markets globally; AVT04 in 23 markets; Eylea biosimilar AVT06 application accepted in Europe, plans to launch in Europe in 2025; Simponi and Prolia/Xgeva candidates making progress with EMA acceptance and filing plans.

Total revenues for the first nine months of 2024 were $339 million, a nearly 9-fold increase compared to the same period in 2023. Product revenues for the first nine months reached $128 million. In the third quarter, product revenues were $62 million, the highest recorded quarter, up 16% from the second quarter. Product margin in Q3 was 37% compared to 17% in Q2, driven by increased shipments of AVT02 to the US and new launches of AVT04 in Europe. Milestone revenues year-to-date exceeded $210 million, with $41 million recognized in Q3 from milestones related to submissions and product launches.

• Revenue guidance for 2024: $400 million to $500 million, driven by new product launches and milestones.
• Product Revenues: Expect shipments of AVT02 to continue stepping up in Q4, with potential pre-launch revenues of AVT04 before year end.
• Cash Interest: Forecasted cash interest payments in 2024 between $45 million and $50 million due to loan facility options exercised.

• FDA Inspection Observations: Two observations from the inspection, but easily addressable and viewed as a validation of compliance efforts.
• Guidance Uncertainties: Potential spillover of shipments into 2025 affecting revenue and margin projections due to timing of orders and commercial negotiations.

Q: Comment on early FDA inspection and 483s; guidance spread A: FDA inspection cadence is every two years, observations are easily addressable; guidance spread due to potential shipment timing into 2025 Q: FDA inspection impact on Stelara launch; guidance stability A: Inspections won't hold off launches; old guidance of $600M-$800M still valid until new guidance Q: Gross profit margin expectation; US product sales breakout A: Product margins expected to expand; no breakout of US product sales by product, ex-US contribution significant