Company reports Q1 2024 XHANCE net revenue of $14.9 million, an increase of 26% compared to Q1 2023 Company expects full year 2024 XHANCE net revenues to be between $85.0 to $95.0 million Company expects peak year XHANCE net revenues of at least $300 million from current specialist focused prescriber audience Company expects to produce positive income from operations (GAAP) for full year 2025 Conference call and webcast to be held today at 10:00 a.m. Eastern Time YARDLEY, Pa., May 14, 2024 (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 March 31, 2024, and provided recent operational highlights. "We are proud that in March, based on evidence including multiple randomized placebo-controlled trials, XHANCE was approved by the FDA as the first prescription medication proven safe and effective for the large population with chronic rhinosinusitis who do not have nasal polyps. Millions of people can potentially benefit from this landmark approval because, despite being one of the most common diagnoses in adult outpatient medicine, there has never been an approved prescription treatment for Chronic Sinusitis," stated CEO Ramy Mahmoud, MD, MPH. "We estimate that the new indication grows the total addressable market by up to ten times and, we've launched into the new opportunity with our current commercial infrastructure aimed primarily at specialty prescribers. We believe that approach will produce positive income from operations for full year 2025, and peak year net revenues of at least $300 million. However, there is considerable incremental potential that could derive from additional efforts in primary care or with activation of tens of millions of people who may have interest in a new and effective treatment option for this disease." First Quarter 2024 and Recent Highlights XHANCE Supplemental New Drug Application (sNDA)On March 15, 2024, the U.S. Food and Drug Administration (FDA) approved XHANCE® (fluticasone propionate) in the Exhalation Delivery System™ as the first and only medication indicated for treatment of chronic rhinosinusitis without nasal polyps in adult patients. Publication of ReOpen Clinical Program ResultsIn January 2024, peer-reviewed data from the landmark ReOpen program evaluating the efficacy and safety of XHANCE in adult patients with chronic rhinosinusitis (chronic sinusitis) was published online in the Journal of Allergy and Clinical Immunology: In Practice. As detailed in the publication, both trials showed statistically significant improvement in symptoms, in inflammation inside the sinuses, and in the number of acute disease exacerbations that occurred in patients treated with XHANCE compared to patients receiving vehicle combined with the Exhalation Delivery System (EDS-placebo). FDA Approval of Second Manufacturing SiteIn March 2024, the FDA approved Hikma Pharmaceuticals USA Inc.'s affiliate West-Ward Columbus Inc., as an additional manufacturing site for finished XHANCE units for commercial sale and sampling. As a result, there are now two sites approved by the FDA for the manufacturer of finished XHANCE units for commercial sale and sampling. $55 Million Registered Direct OfferingOn May 10, 2024 the Company completed a registered direct offering of its common stock and pre-funded common stock warrants to a group of existing and new institutional investors expected to result in approximately $55 million of net proceeds to the Company. The Company expects that its post-offering cash and cash equivalents of approximately $100 million will be sufficient to fund its operations and debt service obligations through 2025. First Quarter 2024 Financial Results Total revenuesThe Company reported $14.9 million in net revenue from sales of XHANCE during the three-month period ended March 31, 2024, an increase of 26% compared to $11.8 million during the three-month period ended March 31, 2023. Costs and expenses and net lossFor the three-month period ended March 31, 2024, research and development expenses were $1.2 million and selling, general and administrative expenses were $20.5 million. The net loss for the period was $14.1 million, or $0.12 per share (basic and diluted). Balance SheetThe Company had cash and cash equivalents of $51.6 million as of March 31, 2024. The cash and cash equivalents balance of $51.6 million does not include the approximately $55 million of net proceeds expected from the Company's registered direct offering that closed on May 10, 2024. Financial Guidance XHANCE Net Revenue and Average The Company expects XHANCE net revenues for the full year of 2024 to be between $85.0 to $95.0 million. XHANCE Average Net Revenue per PrescriptionThe Company expects full year 2024 XHANCE average net revenue per prescription to exceed $230. Previously the Company expected full year 2024 XHANCE average net revenue per prescription to be approximately $220. Operating ExpensesThe Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2024 to be between $95.0 to $101.0 million, of which the Company expects stock-based compensation to be approximately $6.0 million. Net Income from OperationsThe Company expects to product positive income from operations (GAAP) for full year 2025. Company to Host Conference CallMembers of the Company's leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning 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/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. OptiNose, Inc. Condensed Consolidated Statement of Operations (in thousands, except share and per share data) (Unaudited)               Three Months Ended     March 31,       2024       2023   Revenues:         Net product revenues   $14,880     $11,846   Total revenues     14,880