YARDLEY, Pa. - Optinose (NASDAQ:OPTN), a specialty pharmaceutical company, announced today that it has received FDA approval for a new indication of its XHANCE (fluticasone propionate) nasal spray to treat chronic rhinosinusitis without nasal polyps in adults.
This approval positions XHANCE as the first and only drug treatment for this condition. The company also reported that its preliminary net revenue for XHANCE was $14.9 million for the first quarter of 2024, a 26% increase from the same period last year.
CEO Ramy Mahmoud, MD, MPH, stated that Optinose plans to utilize its existing commercial infrastructure, which includes 75 sales territories, to target the estimated 3 million chronic sinusitis patients under the care of ENT and allergy specialists.
This approach is expected to require minimal additional spending. The company has optimized its sales alignment and partnered with a specialty pharmacy hub to enhance patient and physician office experiences and improve prescription fill and reimbursement rates.
Optinose projects that its focused efforts on specialty prescribers could potentially increase XHANCE's peak annual net revenues to over $300 million. Furthermore, the company anticipates generating positive income from operations for the full year 2025.
The company will host an investor call at 10:00 a.m. Eastern Time today to further discuss its commercial strategy and financial outlook. The call can be accessed via webcast on the Optinose website or by telephone registration.
XHANCE utilizes the Exhalation Delivery System to administer a topical steroid to the nasal cavity, targeting areas where sinuses ventilate and drain. The product is also approved for treating chronic rhinosinusitis with nasal polyps in adults.
Important safety information for XHANCE includes contraindications for hypersensitivity to any ingredient, warnings for local nasal adverse reactions, glaucoma, cataracts, hypersensitivity reactions, immunosuppression, infections, hypercorticism, and adrenal suppression, and potential adverse reactions such as epistaxis, headache, and nasopharyngitis.
The information in this article is based on a press release statement from Optinose, Inc.
InvestingPro Insights
As Optinose (NASDAQ:OPTN) celebrates the FDA approval for a new indication of its XHANCE nasal spray and reports a promising increase in preliminary net revenue, the financial metrics and market performance of the company provide a nuanced perspective.
With a market capitalization of $104.24 million and a gross profit margin impressively standing at 87.84% for the last twelve months as of Q4 2023, Optinose showcases a strong ability to generate profit from its sales.
Still, it is worth noting that the company's stock has experienced significant volatility, with a 1-month price total return showing a steep decline of -38.31%. This may reflect market reactions to the company's financial health, as indicated by an adjusted P/E ratio of -2.94, suggesting that investors are cautious about the company's earnings prospects. Moreover, an InvestingPro Tip highlights that Optinose is quickly burning through cash, which could raise concerns about its long-term financial sustainability.
Investors interested in a deeper dive into Optinose's financial performance and market potential can find further InvestingPro Tips, with 8 additional insights available, including analysis on the company's cash flow situation and market trends. For those considering an investment in Optinose, using the coupon code PRONEWS24 can secure an extra 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to valuable tools and information to make informed decisions.
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