YARDLEY, PA — Optinose (NASDAQ: OPTN), has released its financial results for the quarter and year ending December 31, 2023. The report indicates a slight dip in revenue, but highlights the company’s significant strides towards gaining approval for the first-ever medication aimed at treating chronic sinusitis.
Optinose CEO, Ramy Mahmoud, MD, MPH, commented on the company’s strategic focus throughout 2023, which has been primarily on achieving regulatory approval for this groundbreaking treatment. The Food and Drug Administration (FDA) is expected to reach a decision by March 16, 2024.
The proposed treatment involves the use of XHANCE® (fluticasone propionate), delivered through Optinose’s proprietary Exhalation Delivery System™, for adults suffering from chronic rhinosinusitis – commonly known as chronic sinusitis. The FDA accepted Optinose’s Supplemental New Drug Application (sNDA) for this new indication in May 2023.
Optinose also announced the publication of data from its ReOpen Clinical Program earlier this year. This research evaluated the safety and efficacy of XHANCE in treating adult patients with chronic sinusitis. The results, published in the Journal of Allergy and Clinical Immunology: In Practice, indicated significant improvements in symptoms, reduced inflammation, and fewer acute disease exacerbations in patients treated with XHANCE compared to a control group.
However, despite these promising developments, Optinose reported a decrease in net revenue for both the fourth quarter and full year of 2023. Fourth quarter revenues dipped 5% to $19.9 million from $20.9 million in the same period of 2022. The full-year revenue saw a 7% drop to $71.0 million from $76.3 million in 2022.
The company’s financials also revealed a decrease in total expenses for research and development (R&D), and selling, general and administrative (SG&A) costs, which together fell by $37.8 million, or 31%, to $85.1 million for the full year. However, Optinose ended 2023 with a net loss of $35.5 million, or $0.32 per share.
Looking ahead, Optinose expects XHANCE net revenues for the first quarter of 2024 to be approximately $13.0 million. The company also projects an average net revenue per prescription of roughly $220 for XHANCE in the full year 2024.
While the financial results show a challenging year for Optinose, the potential approval of their chronic sinusitis treatment could mark a significant turning point for the company and offer much-needed relief for patients suffering from this common condition.
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