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Sep 30, 2023
Optinose Q3 2023 Earnings Report
Reported XHANCE net revenue of $19.8 million and increased full year 2023 XHANCE net revenue guidance.
Key Takeaways
Optinose reported Q3 2023 financial results, featuring XHANCE net revenue of $19.8 million. The company has increased its full-year 2023 XHANCE net revenue guidance and significantly improved operating efficiency with a 33% reduction in SG&A and R&D expenses year-to-date.
XHANCE net revenue for Q3 2023 was $19.8 million.
Full year 2023 XHANCE net revenue guidance increased.
SG&A and R&D expenses decreased by 33% year-to-date.
PDUFA goal date for XHANCE Chronic Rhinosinusitis sNDA is December 16, 2023.
Optinose
Optinose
Forward Guidance
Optinose expects XHANCE net revenues for the full year of 2023 to be between $66.0 to $70.0 million. The Company continues to expect total GAAP operating expenses for 2023 to be in the range of $88.0 to $93.0 million.
Positive Outlook
- XHANCE net revenues for the full year of 2023 to be between $66.0 to $70.0 million.
- Full year 2023 XHANCE average net revenue per prescription to be approximately $200.
- Total GAAP operating expenses for 2023 to be in the range of $88.0 to $93.0 million.
- Potential approval of XHANCE for chronic sinusitis could lead to rapid adoption.
- Company is preparing for a successful launch in 2024.
Challenges Ahead
- Potential non-compliance with certain covenants under the Amended and Restated Pharmakon Note Purchase Agreement.
- The company's ability to continue as a going concern is under substantial doubt.
- Decrease of 1% in net revenue from sales of XHANCE compared to the three-month period ended September 30, 2022.
- Risk of varying interpretation of the results from the ReOpen program.
- Uncertainties related to the clinical development program and regulatory approval of XHANCE for the treatment of chronic rhinosinusitis.