OPTN - Optinose Reports Third Quarter 2023 Financial Results and Operational Updates | Benzinga

Company reports third quarter 2023 XHANCE net revenue of $19.8 million and increases full year 2023 XHANCE net revenue guidance

Strong improvement in operating efficiency as SG&A and R&D expenses decreased by $32M or 33% year-to-date

PDUFA goal date for XHANCE Chronic Rhinosinusitis sNDA is December 16, 2023

Conference call and webcast to be held today at 8:00 a.m. Eastern Time

YARDLEY, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended September 30, 2023, and provided operational updates.

"We are excited as we approach a potentially transformative period for the company," stated CEO Ramy Mahmoud, MD, MPH. Our effort to secure the first-ever drug approval for patients with chronic sinusitis (CS) is progressing towards the FDA's target goal date of December 16, 2023. Claims data suggest that CS is currently being diagnosed by healthcare providers at least 10 times more frequently than nasal polyps, our current indication for XHANCE. We are pleased with the progress we made in the third quarter towards our 2023 operating objectives while sharply reducing expenses. Today's results show that we are outperforming our initial expectations for 2023 XHANCE net revenues while operating far more efficiently and preparing our organization for a successful launch in 2024. This progress positions us well, if the new indication is approved, to achieve rapid adoption of XHANCE for treatment of the tens of millions of chronic sinusitis patients in need of an effective medication."

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) in the Exhalation Delivery System™ seeking a new indication for treatment of adults with chronic rhinosinusitis. The assigned Prescription Drug User Fee Act (PDUFA) goal date is December 16, 2023.

Third Quarter 2023 Financial Results

Total revenues
The Company reported $19.8 million in net revenue from sales of XHANCE during the three-month period ended September 30, 2023 a decrease of 1% compared to $20.1 million during the three-month period ended September 30, 2022. For the nine-month period ended September 30, 2023 the Company reported $51.1 million in net revenue from sales of XHANCE a decrease of 8% compared to $55.4 million during the nine-month period ended September 30, 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 sinusitis.

Costs and expenses and net (loss) income
For the three-month and nine-month periods ended September 30, 2023, research and development expenses were $1.3 million and $4.0 million, respectively. Selling, general and administrative expenses were $18.0 million and $60.8 million for the three-month and nine-month periods ended September 30, 2023, respectively. In total, SG&A plus R&D expenses decreased by $31.8 million, or 33%, to $64.9 million for the nine-month period ended September 30, 2023 when compared to the nine-month period ended September 30, 2022 total of $96.7 million.

The net loss for the three-month and nine-month period ended September 30, 2023, was $9.3 million, or $0.08 per share, and $25.5 million, or $0.23 per share (basic and diluted), respectively. Net loss for the three-month and nine-month period ended September 30, 2022 was $15.0 million, or $0.18 per share, and $59.7 million, or $0.72 per share (basic and diluted), respectively.

Balance Sheet
The Company had cash and cash equivalents of $66.8 million as of September 30, 2023.

Corporate Guidance

XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2023 to be between $66.0 to $70.0 million. Previously, the Company expected XHANCE net revenues for the full year of 2023 to be between $64.0 to $70.0 million. In addition, the Company continues to expect the full year 2023 XHANCE average net revenue per prescription to be approximately $200.  

Operating Expenses
The Company continues to expect 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.

Company to Host Conference Call

Members of the Company's leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

Participants may access the conference call live via webcast by visiting the Investors section of Optinose's website at https://ir.optinose.com/presentations. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a personal PIN that can be used to access the call. In addition, a replay of the webcast will be available on the Company website for 60 days following the event.

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