Core Viewpoint - Optinose, Inc. will implement a 1-for-15 reverse stock split to comply with Nasdaq's minimum bid price requirement, effective December 30, 2024 [1][5]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of issued and outstanding shares from approximately 150,829,507 to about 10,055,300 [6]. - The reverse stock split was approved by stockholders on December 23, 2024, and the specific ratio was subsequently approved by the Board [1][6]. - All outstanding options and warrants will be adjusted accordingly, and stockholders will receive cash for any fractional shares based on the closing price on December 30, 2024 [6]. Group 2: Compliance and Future Plans - The reverse stock split aims to help Optinose regain compliance with the $1.00 minimum closing bid price required for continued listing on Nasdaq [5]. - The company will continue to operate under the existing trading symbol "OPTN" on a split-adjusted basis starting December 31, 2024 [1]. Group 3: Additional Information - Broadridge Corporate Issuer Solutions, Inc. will act as the exchange and transfer agent for the reverse stock split, providing instructions to stockholders regarding the exchange process [2]. - Further details about the reverse stock split can be found in Optinose's Definitive Proxy Statement filed with the SEC on December 12, 2024 [7].

YARDLEY, Pa., Dec. 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 that members of its management team will present a company overview and business update at the Piper Sandler 36th Annual Healthcare Conference on December 5, 2024 at 1:30 p.m. ET. To listen to a webcast of the presentation live, please visit the Investors page of the Optinose website. A replay of the webcast will b ...

Financial Data and Key Metrics Changes - OptiNose reported $20.4 million in XHANCE net revenue for Q3 2024, a 3% increase compared to $19.8 million in Q3 2023 [38] - The average net revenue per prescription for Q3 2024 was $320, a 36% increase from $236 in Q3 2023 [39] - Year-to-date through September 2024, XHANCE net revenue was $55.8 million, a 9% increase from $51.1 million in the prior year [41] - Operating expenses for Q3 2024 were $20.4 million, up from $19.3 million in Q3 2023, attributed to promotional efforts [40] Business Line Data and Key Metrics Changes - The company is focusing on growing profitable prescriptions rather than overall volume, which has shaped 2024 performance [13] - XHANCE's peak year net revenue objective remains at least $300 million, with a focus on specialty markets [12] Market Data and Key Metrics Changes - Approximately 70% of lives are in insurance plans that cover XHANCE, but about 50% of commercial covered lives are subject to prior authorizations [30] - The company has seen a recent inflection in new prescription growth, with a four-week moving average reaching approximately 2,300 to 2,500 new prescriptions per week in October, representing a growth of 20% to 40% [36] Company Strategy and Development Direction - The company aims to achieve peak annual net revenue exceeding $300 million through specialty-focused efforts and is exploring entry into the primary care market [9][12] - The strategic direction includes enhancing HCP targeting, improving payer access, and optimizing prescription fulfillment processes [11][15] Management's Comments on Operating Environment and Future Outlook - Management acknowledges that while Q3 revenue was below expectations, there is a clear inflection in new prescription demand, reinforcing long-term growth potential [10][22] - The company has adjusted its full-year 2024 revenue guidance to a range of $75 million to $79 million, down from previous expectations of $85 million to $90 million [21] Other Important Information - The company is actively working to improve insurance coverage quality and reduce prior authorization burdens to facilitate patient access to XHANCE [33] - The management team emphasizes the importance of continuous improvement in sales execution and prescription fulfillment [18][19] Q&A Session Summary Question: Factors prompting conservative Q4 guidance - Management indicated that inventory stocking in Q3 affected revenue, and they expect a step up in demand in Q4 [51] Question: Proportion of plans covering new indication - Management noted that most plans have updated their coverage to include both approved indications, though specifics are hard to quantify [52] Question: Update on full-year profitability guidance for 2025 - Management is evaluating performance and will not provide guidance for 2025 at this time [53][54] Question: Cost structure and spending management - Management stated that spending is being cautiously monitored, with a focus on responsiveness to investments and growth [57][58] Question: Net revenue per prescription comparison - Management confirmed that the average net revenue per prescription was $320 in Q3, up from $309 in Q2 [61] Question: Uptake differences between polyp and non-polyp patients - Management expressed difficulty in distinguishing business segments based on diagnosis, emphasizing the need to focus on overall business performance [67][68] Question: Pushback from prescribers regarding XHANCE - Management indicated that the challenge lies in educating prescribers about the benefits of XHANCE, rather than outright pushback [69][70]

optinose® | --- | --- | --- | --- | --- | |-------|-------|-------|----------------------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | Building a Leading ENT / Allergy | | | | | | | | | | | | Specialty Company | | | | | | | | | | | | | | | | | | | | | | | | Corporate Presentation | | | | | | November 12, 2024 | | | | | | | | | | | | | | | | | | | | | | | | | | 2 Forward-Looking Statements This presentation and our accompanying remarks contain "forward-looking statements" with ...

Company Performance - OptiNose reported break-even quarterly earnings per share, surpassing the Zacks Consensus Estimate of a loss of $0.05, compared to a loss of $0.08 per share a year ago, representing an earnings surprise of 100% [1] - The company posted revenues of $20.44 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 10.51%, and showing an increase from year-ago revenues of $19.82 million [2] - Over the last four quarters, OptiNose has surpassed consensus EPS estimates three times, but has topped consensus revenue estimates only once [2] Stock Performance - OptiNose shares have lost about 40.5% since the beginning of the year, while the S&P 500 has gained 25.8% [3] - The current consensus EPS estimate for the coming quarter is -$0.03 on revenues of $27.92 million, and -$0.22 on revenues of $86.17 million for the current fiscal year [7] Industry Outlook - The Medical - Drugs industry, to which OptiNose belongs, is currently in the top 27% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Financial Performance - Net product revenues for the three months ended September 30, 2024, were $20,437,000, up from $19,823,000 for the same period in 2023, reflecting a 3% growth[18]. - Total revenues for the nine months ended September 30, 2024, reached $55,807,000, compared to $51,122,000 for the same period in 2023, indicating a 9% increase[18]. - The company reported a net income of $467,000 for the three months ended September 30, 2024, a significant improvement from a net loss of $(9,294,000) in the same period in 2023[20]. - As of September 30, 2024, the company reported a net loss of $21,181,000, an improvement from a net loss of $25,516,000 for the same period in 2023[26]. - For the three months ended September 30, 2024, the net income was $467,000 compared to a net loss of $9,294,000 for the same period in 2023[62]. - The basic net income per share for the three months ended September 30, 2024, was $0.00, while the basic net loss per share for the same period in 2023 was $(0.08)[62]. Cash and Cash Equivalents - Cash and cash equivalents increased to $82,497,000 as of September 30, 2024, from $73,684,000 at December 31, 2023, representing a 11% increase[15]. - The company reported a net increase in cash and cash equivalents of $8,812,000 for the nine months ended September 30, 2024[26]. - The company had cash and cash equivalents of $82,497,000 and a working capital deficit of $34,215,000 as of September 30, 2024[30]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $949,000, down from $1,281,000 in the same period of 2023, a decrease of 26%[18]. - Selling, general and administrative expenses increased to $19,475,000 for the three months ended September 30, 2024, compared to $18,011,000 for the same period in 2023, a rise of 8%[18]. - Stock-based compensation for the nine months ended September 30, 2024, was $5,481,000, compared to $4,219,000 for the same period in 2023[26]. - Interest expense for the three months ended September 30, 2024, was $5,294, an increase of 7.2% from $4,940 in the same period of 2023[97]. - The Company recorded depreciation expense of $65 for the three months ended September 30, 2024, compared to $102 for the same period in 2023, reflecting a decrease of 36.3%[82]. Liabilities and Deficits - The accumulated deficit increased to $(741,557,000) as of September 30, 2024, from $(720,376,000) at December 31, 2023[15]. - Total liabilities decreased to $172,117,000 as of September 30, 2024, from $194,335,000 at December 31, 2023, a reduction of approximately 11%[16]. - The principal balance outstanding under the amended Note Purchase Agreement was $130,000,000 as of September 30, 2024[34]. - The company has substantial doubt about its ability to continue as a going concern within one year after the issuance of the consolidated financial statements[38]. - The Company has classified all outstanding principal and additional fees as current liabilities due to the likelihood of not maintaining compliance with required sales thresholds[95]. Inventory and Accounts Receivable - The total inventory as of September 30, 2024, was $11,301,000, an increase from $8,052,000 as of December 31, 2023[80]. - Five customers accounted for approximately 78% of the company's accounts receivable as of September 30, 2024, and represented about 74% of net product sales for the three months ended September 30, 2024[44]. Capital Raising and Offerings - The company completed a registered direct offering on May 10, 2024, raising net proceeds of $55.3 million by issuing 31,800,000 shares of common stock at $1.00 per share[32]. - The Company issued 4,680,000 shares of common stock to satisfy $4,680 of outstanding amendment and waiver fees under the A&R Note Purchase Agreement[93]. - The company completed a registered direct offering on May 10, 2024, issuing 31,800,000 shares of common stock at $1.00 per share, along with pre-funded warrants for 23,700,000 shares at $0.999 each[102]. Stock Options and Compensation - The company granted 1,703,101 service-based stock options during the nine months ended September 30, 2024, with a weighted average grant date fair value of $1.56[108]. - The unrecognized compensation cost related to unvested stock options expected to vest as of September 30, 2024, was $3,513,000, to be recognized over an estimated weighted-average amortization period of 2.4 years[109]. - The expected volatility for stock options granted was 75.03% for the nine months ended September 30, 2024[112]. - The company had 9,108,884 stock options outstanding as of September 30, 2024, with a weighted average exercise price of $4.04[108]. Future Outlook and Concerns - The company anticipates it will not meet the minimum trailing twelve-month consolidated XHANCE net sales and royalties thresholds under the A&R Note Purchase Agreement, which could lead to a default[37]. - Starting September 30, 2025, the company will need to make principal repayments of $16.3 million in eight quarterly installments until June 2027[36]. - The company may need to delay or curtail operations if it cannot accelerate growth in net revenues or obtain necessary modifications to its debt covenants[38]. - The company has incurred recurring net losses since inception, highlighting the need for continued capital raising and product development efforts[31]. Product Information - The company’s first commercial product, XHANCE, is focused on treating chronic rhinosinusitis, utilizing a proprietary delivery system[29]. - The company recognizes revenue from XHANCE sales upon delivery, including estimates of variable consideration such as chargebacks and discounts[51]. - The company is subject to discount obligations under state Medicaid programs and Medicare, which are recorded as liabilities in the same period the related revenue is recognized[54].

Optinose Reports Third Quarter 2024 Financial Results and Recent Operational Highlights Company reports Q3 2024 XHANCE net revenue of $20.4 million, an increase of 3% compared to Q3 2023 Company reports positive inflection in new prescriptions of XHANCE starting in September Company decreases full year 2024 XHANCE net revenue guidance to be between $75.0 to $79.0 million and increases expected average net revenue per prescription guidance to be approximately $270 Company decreases full year 2024 operating e ...

Core Viewpoint - The company reported a 3% increase in net revenue for XHANCE in Q3 2024 compared to Q3 2023, with a positive trend in new prescriptions observed starting in September 2024 [1][4][2]. Financial Performance - Q3 2024 net revenue from XHANCE was $20.4 million, up from $19.8 million in Q3 2023 [4]. - For the nine-month period ended September 30, 2024, total net revenue was $55.8 million, reflecting a 9% increase from $51.1 million in the same period of 2023 [4]. - The company reported a net income of $0.5 million for Q3 2024, compared to a net loss of $9.3 million in Q3 2023 [6][12]. Prescription Trends - The four-week moving average of new prescriptions (NRx) increased to approximately 2,300 to 2,500 per week in October 2024, marking a 20% to 40% increase compared to the previous range of 1,760 to 1,960 [3][2]. Financial Guidance - The company revised its full-year 2024 net revenue guidance for XHANCE to between $75.0 million and $79.0 million, down from the previous estimate of $85.0 million to $90.0 million [1][6]. - The expected average net revenue per prescription for 2024 is now approximately $270, an increase from the previous expectation of exceeding $250 [7][8]. - Total GAAP operating expenses for 2024 are now expected to be between $90.0 million and $93.0 million, reduced from the earlier guidance of $95.0 million to $101.0 million [9]. Operational Highlights - The company will host a conference call to discuss financial results and corporate updates [10].

Core Insights - Optinose has appointed Terry Kohler as Chief Financial Officer, bringing over 20 years of experience in biotech finance [1][2][3] - Kohler's previous role was at Verrica Pharmaceuticals, where he supported the launch of a topical treatment and R&D investments [2] - The CEO expressed confidence in Kohler's ability to guide the financial strategy for XHANCE, a treatment for chronic rhinosinusitis [3] Company Overview - Optinose is a specialty pharmaceutical company focused on patients treated by ENT and allergy specialists [5] - The company is working to maximize the value of XHANCE, which is approved for chronic rhinosinusitis [3][6] Product Information - XHANCE is a nasal spray designed to deliver a topical steroid to the nasal cavity, approved for chronic rhinosinusitis with and without nasal polyps [6] - The product utilizes the Exhalation Delivery System™ to enhance drug delivery [6] Compensation Details - Kohler received a non-qualified stock option to purchase 675,000 shares at $0.71 per share and 150,000 restricted stock units as part of his inducement to join the company [4] - The stock options and restricted stock units will vest over four years, contingent on Kohler's continuous service [4]

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]