BioMarin Q3 2022 Earnings Report
Key Takeaways
BioMarin announced strong Q3 2022 results, with a 24% increase in total revenue compared to the same period in 2021. VOXZOGO's performance was a key driver, leading to an increased full-year net product revenue guidance. The company also highlighted the European regulatory approval and commercial launch of ROCTAVIAN, as well as the acceptance of the U.S. Biologics Application for ROCTAVIAN by the FDA.
Total revenues increased by 24% year-over-year, reaching $505.3 million.
VOXZOGO contributed $48 million to revenue, leading to an increased full-year net product revenue guidance of $140 to $170 million.
The U.S. Biologics Application for ROCTAVIAN was accepted by the FDA with a PDUFA target action date of March 31, 2023.
Commercial launch of ROCTAVIAN is underway in the European Union following approval in August 2022.
BioMarin
BioMarin
BioMarin Revenue by Segment
Forward Guidance
BioMarin revised its full-year 2022 VOXZOGO net product revenue guidance to between $140 million and $170 million. Total Revenues, VIMIZIM Net Product Revenues, NAGLAZYME Net Product Revenues, PALYNZIQ Net Product Revenues, KUVAN Net Product Revenues, BRINEURA Net Product Revenues, Cost of Sales (% of Total Revenues), GAAP Net Income, and Non-GAAP Income guidance remained unchanged. Research and Development Expense was revised from $665 to $715 million to $650 to $700 million. Selling, General and Administrative Expense was revised from $790 to $840 million to $800 to $850 million.
Positive Outlook
- Total Revenues guidance unchanged at $2,060 to $2,160 million
- VIMIZIM Net Product Revenues guidance unchanged at $655 to $700 million
- NAGLAZYME Net Product Revenues guidance unchanged at $415 to $450 million
- PALYNZIQ Net Product Revenues guidance unchanged at $250 to $275 million
- KUVAN Net Product Revenues guidance unchanged at $210 to $235 million
Challenges Ahead
- BRINEURA Net Product Revenues guidance unchanged at $145 to $160 million
- Cost of Sales (% of Total Revenues) guidance unchanged at 22.5% to 24.5%
- GAAP Net Income guidance unchanged at $105 to $145 million
- Non-GAAP Income guidance unchanged at $350 to $390 million
- Research and Development Expense revised from $665 to $715 million to $650 to $700 million
Revenue & Expenses
Visualization of income flow from segment revenue to net income