OptiNose AS (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced corporate updates detailing its commercial plans and expectations for XHANCE® (fluticasone propionate) following the recent FDA approval of a new indication for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 year of age and older. The Company will host an investor call at 10:00 a.m. Eastern Time today to discuss its commercial strategy and financial outlook.
In addition, the Company announced preliminary XHANCE net product revenue of $14.9 million for the three months ended March 31, 2024, representing growth of approximately 26% over the first quarter of 2023.
“The recent FDA approval of XHANCE as the first and only approved drug treatment for chronic sinusitis (CS) is a landmark achievement,” said Ramy Mahmoud, MD, MPH, CEO of Optinose. “Because we plan to leverage our current commercial infrastructure, including 75 sales territories, we expect to need limited incremental spend to effectively reach the estimated 3 million patients with chronic sinusitis who are cared for by ENT and Allergy specialists. To prepare for an effective launch, we have recently optimized our sales alignment towards a chronic sinusitis call target universe and partnered with a specialty pharmacy hub to improve patient and physician office experience and increase prescription fill and reimbursement rates. Based on our market analysis, we believe that our base planned efforts focused on a specialty prescriber audience can grow XHANCE peak year net revenues to more than $300 million and allow Optinose to produce positive income from operations (GAAP) for full year 2025. With incremental investments in the future, we believe the market opportunity could be expanded to over 30 million patients through outreach to the 7 million patients being treated by primary care physicians and by direct-to-consumer activation of the 20 million patients who report suffering from chronic sinusitis symptoms,” he concluded.
Financial Outlook:
XHANCE Net Revenue
The Company expects peak XHANCE net revenues to exceed $300 million based on its current promotional focus on a specialty audience of mostly ENT and Allergy specialists.
Income from Operations
The Company expects to produce positive income from operations (GAAP) for full year 2025.
Company to Host Conference Call
Members of the Company’s leadership team will host a conference call to discuss corporate updates. The call is scheduled to start at 10:00 a.m. Eastern Time today.
Participants may access the conference call live via webcast by visiting the Investors section of Optinose’s website at http://ir.optinose.com/event-calendar. 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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