Core Insights - Optinose announced the peer-reviewed publication of a study on the efficacy of EDS-FLU in treating chronic rhinosinusitis (CRS) in patients with or without prior sinus surgery [1][4] Company Overview - Optinose is a specialty pharmaceutical company focused on patients treated by ear, nose, and throat (ENT) and allergy specialists [5] - The company’s product, XHANCE, is a drug-device combination approved for treating both chronic rhinosinusitis without nasal polyps and with nasal polyps in patients aged 18 and older [6] Product Efficacy - The study published in the International Forum of Allergy & Rhinology highlighted that the Exhalation Delivery System™ (EDS) allows for effective medication delivery to sinus cavities, which is crucial for treating CRS [2][3] - Results from the ReOpen1 and ReOpen2 trials indicated that XHANCE significantly improved symptoms, sinus opacification, and quality of life in CRS patients, regardless of prior sinus surgery [4] Clinical Trials - The ReOpen1 and ReOpen2 trials were 24-week randomized controlled studies comparing XHANCE to a placebo in CRS patients [3] - The findings suggest that prior sinus surgery is not a prerequisite for patients to benefit from XHANCE treatment [4]

Financial Data and Key Metrics Changes - OptiNose reported $20.5 million in XHANCE net revenue for Q2 2024, a 5% increase from $19.5 million in Q2 2023 [21] - The average net revenue per prescription for Q2 2024 was $309, a 44% increase compared to $214 in Q2 2023 [21] - For the first half of 2024, XHANCE net revenue was $35.4 million, a 13% increase from $31.3 million in the first half of 2023 [23] - The average net revenue per prescription for the first half of 2024 was $269, a 51% increase from $178 in the first half of 2023 [23] - SG&A plus R&D expenses for Q2 2024 were $25.1 million, up from $21.1 million in Q2 2023 [22] Business Line Data and Key Metrics Changes - The launch of XHANCE for chronic sinusitis began in Q2 2024, with a focus on educating prescribers and increasing adoption [4][5] - The company aims for peak year sales of at least $300 million for XHANCE in chronic sinusitis by 2025 [6] - The net revenue guidance for XHANCE for full year 2024 has been narrowed to $85 million to $90 million, reflecting a growth of 20% to 27% compared to 2023 [11][26] Market Data and Key Metrics Changes - XHANCE was added to large Express Scripts' national formularies, improving access for over 24 million lives [17] - The new preferred formulary coverage simplifies the prescribing process, eliminating prior authorization paperwork for prescribers [18] Company Strategy and Development Direction - The company is focusing on profitable business lines and moving away from lower profit and unprofitable business [10] - The strategy includes leveraging a central intake pharmacy model (HUB) to improve patient support and prescription fulfillment [20] - The management believes that the chronic sinusitis indication will facilitate commercial partnerships and expand market reach [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential of XHANCE, indicating that the company is in the early stages of its launch [27] - The company anticipates gradual growth in the coming quarters as it implements insurance coverage changes and educates prescribers [9] - Management expects to achieve positive income from operations for the full year 2025 [26] Other Important Information - The company has increased its expectation for XHANCE net revenue per prescription for full year 2024 to at least $250, up from a previous expectation of at least $230 [10] - The company plans to maintain operating expenses modestly incremental to 2023 levels to support promotional efforts [24] Q&A Session Summary Question: What are your assumptions for your path to profitability? - Management expects revenue growth of 20% to 27% for the year and believes peak revenue potential for XHANCE is approximately $300 million, indicating a clear pathway to profitability by 2025 [30] Question: Are you confident about meeting the revenue covenant in the third quarter? - Management is confident about meeting the revenue covenant, expecting to maintain compliance with the target of $72.5 million for the third quarter [31] Question: Is the average net revenue per prescription of $250 conservative? - Management acknowledges the current average net revenue per prescription is $269 and allows for flexibility in their estimates due to potential lower profit volumes [32][33] Question: What has been the engagement with payers regarding coverage expansion? - Payers are noticing increased demand for XHANCE due to the new indication, leading to improved access and coverage discussions [35]

OptiNose (OPTN) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to earnings of $0.02 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of 12.50%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.10 per share when it actually produced a loss of $0.12, delivering a surprise of -20%. Over the last four quarters, the ...

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 June 30, 2024 ☐ 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 OPTINOSE, INC. (Exact name of registrant as specified in its charter) Delaware 42-1771610 (State ...

Financial Performance - Optinose reported Q2 2024 XHANCE net revenue of $20.5 million, a 5% increase from $19.5 million in Q2 2023[1][4] - The company narrowed its full year 2024 XHANCE net revenue guidance to between $85.0 million and $90.0 million[1][6] - The company reported a 13% increase in net revenue from XHANCE for the six-month period ended June 30, 2024, totaling $35.4 million[4] - The average net revenue per prescription for XHANCE is expected to exceed $250 for the full year 2024, up from a previous estimate of $230[1][7] - The net loss for Q2 2024 was $7.6 million, or $0.07 per share (diluted)[5] Expenses - Research and development expenses for Q2 2024 were $0.9 million, while selling, general, and administrative expenses were $24.1 million[5] - Total GAAP operating expenses for 2024 are expected to be between $95.0 million and $101.0 million[1][8] - The company has outlined expectations for GAAP operating expenses and stock-based compensation for 2024[17] Cash Position - As of June 30, 2024, the company had cash and cash equivalents of $91.4 million[6][12] - The company completed a registered direct offering resulting in approximately $55 million of net proceeds[3] - The company anticipates that its current cash and cash equivalents will be sufficient to fund operations and debt service obligations through 2025[17] Market Opportunities - XHANCE is the first FDA-approved drug treatment for chronic rhinosinusitis without nasal polyps, presenting expanded market opportunities[17] - XHANCE has been added to Express Scripts' national formularies, covering over 24 million lives[2] - The company expects XHANCE net revenue and average net revenue per prescription to grow in full year 2024[17] Risks and Uncertainties - Risks include physician and patient acceptance of XHANCE for its new indication and maintaining adequate third-party reimbursement[17] - The prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected[17] - The company faces uncertainties related to intellectual property and competitive products[17] - Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially[17] - The company will monitor for signs of increased drug exposure in patients with hepatic impairment[17] Strategic Focus - The company is focused on gradually improving insurance barriers to enhance future XHANCE net revenue growth[17]

YARDLEY, Pa., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the Company will report financial results for the second quarter 2024 and corporate updates, before market open, on Thursday, August 8, 2024. Company to Host Conference Call Members of the Company's leadership team will host a conference call to discuss financial results and corporate updates. The call is scheduled ...

YARDLEY, Pa., June 27, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that XHANCE® (fluticasone propionate) has been added to Express Scripts' national formularies, including the National Preferred, Flex, and Basic formularies, among the largest commercial formularies in the U.S. with more than 24 million lives. "XHANCE is approved for treatment of chronic rhinosinusitis and, importa ...

OptiNose, Inc. (NASDAQ:OPTN) Q1 2024 Results Conference Call May 15, 2024 10:00 AM ET Company Participants Jonathan Neely - VP, IR & Business Development Dr. Ramy Mahmoud - CEO Conference Call Participants Thomas Flaten - Lake Street Capital Markets Schuyler van den Broek - Piper Sandler Glen Santangelo - Jefferies Matthew Caufield - H.C. Wainwright Operator Good day, and thank you for standing by. Welcome to the OptiNose's Q1 2024 Earnings Conference Call. At this time, all participants are in a listen-onl ...

Company Overview - Optinose is a specialty pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists [3] - The company will present a business update at the H.C. Wainwright 2nd Annual BioConnect Investor Conference on May 20, 2024 [1] Event Details - The presentation will take place at NASDAQ at 11:30 a.m. ET [1] - A replay of the webcast will be available for 30 days following the event [2] Investor Relations - For further inquiries, Optinose's investor contact is Jonathan Neely, reachable at jonathan.neely@optinose.com or 267.521.0531 [4]

YARDLEY, Pa., May 17, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced that members of its management team will present a company overview and business update at the H.C. Wainwright 2nd Annual BioConnect Investor Conference at NASDAQ on May 20, 2024 at 11:30 a.m. ET. To listen to a webcast of the presentation live, please visit the Investors page of the Optinose website. A replay of th ...