YARDLEY, PA — Optinose (NASDAQ: OPTN), a pharmaceutical company, reported financial results for the quarter ended March 31, 2023, and provided operational updates.
“We are pleased with the progress we made in the first quarter of 2023 towards our strategic objectives,” stated CEO Ramy Mahmoud, MD, MPH. “Our effort to secure the first-ever drug approval for patients with chronic sinusitis took a major step forward last week when we announced that our supplemental new drug application was accepted for review with a target goal date of December 16, 2023. We are preparing our organization for a successful launch and operating more efficiently in our current business. These objectives are aimed at rapidly achieving uptake in the millions of chronic sinusitis patients in need of an effective therapy.”
First Quarter 2023 and Recent Highlights
Chronic Rhinosinusitis Supplemental New Drug Application (sNDA)
In May the Company announced that the U.S. Food and Drug Administration (FDA) accepted its sNDA for XHANCE® (fluticasone propionate) Exhalation Delivery System™ seeking a new indication for treatment of adults with chronic rhinosinusitis. The assigned Prescription Drug User Fee Act (PDUFA) target goal date is December 16, 2023.
Additional U.S. Patents Covering XHANCE
The United States Patent and Trademark Office (USPTO) recently issued two additional patents covering XHANCE. These patents, U.S. Patents 11,554,229 and 11,602,603, have been listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for XHANCE and have terms that expire in years 2036 and 2028, respectively. XHANCE is now covered by 15 Orange Book-listed patents.
The full text of each patent is available on the USPTO website www.uspto.gov.
First Quarter 2023 Financial Results
The Company reported $11.8 million in net revenue from sales of XHANCE during the three-month period ended March 31, 2023, a decrease of 20% compared to $14.8 million during the three-month period ended March 31, 2022. The year-over-year decrease in net revenue is consistent with the Company’s previously communicated intent to prioritize its capital resources for a potential launch of XHANCE for the treatment of chronic rhinosinusitis and its guidance for first quarter 2023 net revenues to be approximately $10.0 million.
Costs and expenses and net loss
For the three-month period ended March 31, 2023, research and development expenses were $1.8 million and selling, general and administrative expenses were $22.7 million. The net loss for the period was $18.8 million, or $0.17 per share (basic and diluted).
The Company had cash and cash equivalents of $83.9 million as of March 31, 2023.
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2023 to be between $62.0 to $68.0 million. In addition, the Company expects the full year 2023 XHANCE average net revenue per prescription to be approximately $200.
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2023 to be in the range of $88.0 to $93.0 million, of which the Company expects stock-based compensation to be approximately $6.0 million.
Previously the Company expected total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2023 to be in the range of $90.0 to $95.0 million, of which the Company expected stock-based compensation to be approximately $8.0 million.
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