OptiNose (OPTN) came out with a quarterly loss of $0.03 per share versus the Zacks Consensus Estimate of a loss of $0.70. This compares to loss of $1.35 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 95.71%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.75 per share when it actually produced break-even earnings, delivering a surprise of 100%.Over the last four quarters, the ...

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 ...

MONSEY, N.Y., March 20, 2025 (GLOBE NEWSWIRE) -- The law firm of Wohl & Fruchter LLP is investigating the fairness of the proposed sale of OptiNose, Inc. (Nasdaq: OPTN) (“OptiNose”) to Paratek Pharmaceuticals (“Paratek”) for $9.00 per share in cash, plus a contingent value right (“CVR”) worth $5.00 per share payable in the event that certain net revenue milestones are achieved by OptiNose’s flagship drug, XHANCE. Notably, as detailed below, the sale price is below the price target for OptiNose of at least t ...

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]

Core Insights - Optinose reported preliminary unaudited net product revenue of $22.4 million for XHANCE for the fourth quarter of 2024, aligning with prior guidance and indicating sustained growth in prescriptions [1][2] - The company estimates a sequential growth rate of approximately 20% in XHANCE prescriptions from the third quarter to the fourth quarter of 2024, reflecting effective commercial execution [2] Financial Performance - The preliminary unaudited net product revenue of $22.4 million for the three months ended December 31, 2024, is based on available information and may vary upon finalization [2] - Full financial results for the fourth quarter of 2024 are expected to be reported in March 2025 [2] Company Overview - Optinose is a specialty pharmaceutical company focused on patients treated by ear, nose, and throat (ENT) and allergy specialists [3]