UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-38241 (Registrant's telephone number including area code) OPTINOSE, INC. Securities registered pursuan ...

Company Performance - OptiNose reported a quarterly loss of $0.03 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.70, and an improvement from a loss of $1.35 per share a year ago, indicating a 95.71% earnings surprise [1] - The company posted revenues of $22.42 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 5.57% and showing an increase from $19.87 million in the same quarter last year [2] - Over the last four quarters, OptiNose has surpassed consensus EPS estimates three times and topped consensus revenue estimates two times [2] Stock Performance - OptiNose shares have increased by approximately 37.3% since the beginning of the year, contrasting with a decline of 1.8% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.74 on revenues of $17.7 million, and for the current fiscal year, it is -$3.13 on revenues of $91.03 million [7] Industry Outlook - The Medical - Drugs industry, to which OptiNose belongs, is currently ranked in the top 33% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Market Opportunity and Expansion - XHANCE received FDA approval for chronic rhinosinusitis without nasal polyps in March 2024, expanding its market potential significantly[37]. - The company estimates that approximately 15,000 targeted physicians treat an estimated 3.5 million chronic rhinosinusitis patients in the U.S.[42]. - The U.S. healthcare system spends approximately $60 billion annually in direct costs treating patients with chronic rhinosinusitis, including an estimated $5 billion on sinus surgeries[45]. - The company plans to explore expansion into the primary care segment, targeting an additional estimated 6.25 million patients with chronic rhinosinusitis[42]. - The total annual U.S. market opportunity for XHANCE in the specialty segment is estimated to be over $3.4 billion, with an additional $6.0 billion in the primary care segment, totaling over $9.5 billion[49]. - The market opportunity for XHANCE is bolstered by the estimated 10 million adults in the U.S. suffering from chronic rhinosinusitis with nasal polyps[44]. - The company is exploring international market expansion for XHANCE to maximize its commercial potential[48]. Sales and Revenue - Net product revenues from XHANCE sales for the years ended December 31, 2024, 2023, and 2022 are being closely monitored to assess growth[38]. - The company has a sales force of approximately 75 territory managers targeting around 7,000 ENT and allergy specialists[42]. - Approximately 59% of XHANCE net revenues for the fiscal year ended December 31, 2024, were generated from PPN partners, with the largest PPN accounting for 25% of total revenue[83]. - The company believes that around 70% of insured lives are in plans covering XHANCE, but many require prior authorizations, affecting patient access[81]. Clinical Trials and Efficacy - XHANCE demonstrated statistically significant reductions in nasal congestion and polyp grade in Phase 3 clinical trials, comparable to benefits seen in endoscopic sinus surgery[56]. - The clinical trial program for XHANCE included over 1,500 patients across five clinical trials, demonstrating significant efficacy in treating nasal polyps[97]. - In pivotal trials, approximately 16% of patients treated with XHANCE achieved complete elimination of nasal polyps (grade 0) in at least one nostril after 16 weeks, increasing to 27% after an additional eight weeks[98]. - The Phase 3 clinical trial ReOpen1 included 332 adult subjects and showed statistically significant reductions in composite symptom scores and opacified volume of the sinuses at week 24[101][103]. - Statistically significant reductions in composite symptom scores were observed at week 4 for both treatment groups, with XHANCE 372 mcg showing a mean change of -1.74 compared to -0.81 for placebo (p=0.001) and XHANCE 186 mcg showing -1.54 (p=0.011)[118][119]. Safety and Adverse Events - The safety profile of XHANCE was consistent with previous studies, with no serious adverse events reported in ReOpen1[107]. - Common adverse events for XHANCE included epistaxis (11.9% in the 372 mcg group) and nasopharyngitis (5.4% in the 186 mcg group), occurring at rates higher than placebo[108]. - Adverse events occurring at a rate greater than 3% included epistaxis (9.5% for 372 mcg) and headache (9.5% for 372 mcg), both more common than in the placebo group[121][128]. Financial Concerns and Capital Needs - The company anticipates continued losses and may require additional capital to fund operations, raising concerns about its ability to maintain profitability[24]. - The company has transitioned a significant portion of XHANCE business to a patient support program (HUB) to navigate payor restrictions and enhance affordability solutions[82]. Intellectual Property and Regulatory Environment - The company has substantial intellectual property protections for XHANCE, including patents and trade secrets, to maintain its competitive position in the market[129]. - As of March 1, 2024, the company owns over 50 U.S. patents expiring between 2025 and 2036, and over 150 foreign issued patents expiring between 2025 and 2035[131]. - The FDA has included XHANCE on its list for complex generic drug products, which may provide clarity for generic competitors in the next 12 months[132]. - The Federal Trade Commission (FTC) has initiated an administrative process regarding over 100 patent listings, but the company believes its patents for XHANCE are properly listed[133]. Mergers and Acquisitions - The company entered into a Merger Agreement with Paratek Pharmaceuticals, Inc., with the merger expected to be completed in the second or third quarter of 2025[207][209]. - Upon closing, each share of the company's common stock will convert into $9.00 in cash and one contractual contingent value right (CVR) with potential additional payments based on XHANCE sales milestones[208]. Compliance and Legal Matters - The company is subject to various healthcare fraud and abuse laws, which could have material adverse effects on its business if violated[199]. - Compliance with healthcare privacy laws is critical, as failure to comply could result in significant penalties and negative publicity[200]. - The company is not currently involved in any material pending legal proceedings[204].

Revenue Reporting - OptiNose, Inc. reported preliminary unaudited XHANCE net revenue of $22.4 million for the three months ended December 31, 2024[7]. - The reported net revenue is subject to change due to the completion of financial closing procedures and has not been audited[8]. - The company emphasizes that actual results may vary materially from the preliminary results provided[8].

Core Insights - Optinose reported a fourth quarter 2024 net revenue of $22.4 million for XHANCE, representing a 13% increase year-over-year, and a full year revenue of $78.2 million, a 10% increase compared to the previous year [1][3] - The company experienced a 23% growth in total prescriptions from the third quarter to the fourth quarter of 2024, with new prescriptions increasing by 12% during the same period [2][3] Financial Performance - For Q4 2024, net revenue from XHANCE was $22.4 million, up from $19.9 million in Q4 2023, while the full year revenue rose from $71.0 million in 2023 to $78.2 million in 2024 [3] - Research and development expenses for Q4 2024 were $0.8 million, and for the full year, they totaled $3.9 million. Selling, general, and administrative expenses were $19.3 million for Q4 and $83.5 million for the full year [4] - The company reported an income from operations of $0.4 million for Q4 2024, marking the first time it achieved this in a three-month period, while the net loss for the quarter was $0.4 million [5] Balance Sheet - As of December 31, 2024, the company had cash and cash equivalents amounting to $84.5 million, an increase from $73.7 million in the previous year [6][9] - Total assets were reported at $128.8 million, with total current liabilities at $162.8 million, indicating a stockholders' deficit of $40.4 million [9]

Shares of OptiNose (OPTN) have gained 58.6% over the past four weeks to close the last trading session at $9.15, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $22.24 indicates a potential upside of 143.1%.The mean estimate comprises four short-term price targets with a standard deviation of $15.68. While the lowest estimate of $9 indicates a 1.6% decline from the current price ...

Shares of OptiNose (OPTN) soared 52.5% on Thursday after the company announced that it is set to be acquired by Paratek Pharmaceuticals, a private biotech. This deal will add OPTN’s approved product, Xhance (fluticasone propionate), to the latter’s commercial portfolio.Xhance is an innovative drug-device therapy for chronic rhinosinusitis (CRS), with or without nasal polyps. Utilizing its proprietary Exhalation Delivery System, it delivers a corticosteroid directly to the site of inflammation, improving pat ...

Core Viewpoint - The law firm Wohl & Fruchter LLP is investigating the fairness of the proposed sale of OptiNose, Inc. to Paratek Pharmaceuticals for $9.00 per share in cash, plus a contingent value right worth $5.00 per share, due to concerns that the sale price is below analyst price targets and the company's recent high [1][2][3]. Group 1 - The sale price of $9.00 per share, including the CVR, is below the price targets set by at least three Wall Street analysts, which are $18.00, $17.00, and $15.00 per share [5]. - The proposed sale price is significantly lower than OptiNose's 52-week high of $25.80, indicating that the deal may be opportunistic [2][3]. - The investigation aims to determine if the OptiNose Board of Directors acted in the best interests of shareholders and whether all material information regarding the transaction has been disclosed [4].

Core Viewpoint - Optinose has announced the cancellation of its earnings conference call due to its acquisition by Paratek Pharmaceuticals, which is subject to shareholder approval and customary closing conditions [1][2]. Company Overview - Optinose is a specialty pharmaceutical company that focuses on patients treated by ear, nose, and throat (ENT) and allergy specialists [3]. - The company aims to report its financial results for the three- and twelve-month periods ended December 31, 2024, in a timely manner following the acquisition announcement [2]. Acquisition Details - Optinose has entered into a definitive agreement to be acquired by Paratek Pharmaceuticals, which will require shareholder approval and other customary closing conditions [2]. - The earnings conference call that was scheduled for March 20, 2025, has been cancelled as a result of this acquisition announcement [1][2].

Core Viewpoint - Optinose will report its financial results for Q4 and the full year of 2024 on March 20, 2025, before market open [1] Group 1: Financial Results Announcement - The company will provide financial results for the fourth quarter and full year of 2024 [1] - A conference call will be held to discuss these results and corporate updates [2] Group 2: Conference Call Details - The conference call is scheduled for March 20, 2025, at 8:00 a.m. Eastern Time [2] - Participants can access the call via webcast or telephone, with registration required for telephone participation [3] Group 3: Company Overview - Optinose is a specialty pharmaceutical company focused on patients treated by ENT and allergy specialists [4]