Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you comment on the recent FDA inspection and its implications? A: Robert Wessman, Founder, Chairman and CEO, explained that the FDA inspection was a general GMP inspection, which is expected to occur every two years. The inspection was successful with two observations that are easily addressable. These observations will not impact the launch of any products, including the Stelara biosimilar. The company remains prepared for future inspections, especially with upcoming product submissions in the US.
Q: Why hasn't the revenue guidance been tightened given the strong performance so far? A: Joel Morales, Chief Financial Officer, noted that while there has been a rapid increase in revenues, there remains a wide range of potential outcomes due to product mix and shipment timing. Some shipments might move into early 2025, which affects the ability to refine guidance further for the current year.
Q: What are your expectations for gross profit margins over the next 12 to 18 months? A: Joel Morales stated that product margins increased from 17% to 37% in the third quarter. The company expects margins to continue expanding as they exit the year, but no specific guidance for 2025 is being provided at this time.
Q: Could the FDA inspection impact the launch of the Stelara biosimilar next year? A: Robert Wessman confirmed that the FDA inspection will not delay the launch of the Stelara biosimilar. The observations from the inspection are manageable and will not hinder the product's market entry.
Q: What is Alvotech's strategy for launching the biosimilar to Eylea in the US? A: Anil Okay, Chief Commercial Officer, mentioned that the company plans to launch the biosimilar in Europe on day one in 2025. For the US, the strategy involves gaining filing acceptance and addressing IP challenges. The company is optimistic about entering the US market as soon as possible.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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