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]

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., 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 ...

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 ...

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]

Core Viewpoint - OptiNose reported a quarterly loss of $0.12 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.10, marking a 20% earnings surprise [1] - The company achieved revenues of $14.88 million for the quarter ended March 2024, exceeding the Zacks Consensus Estimate by 6.67% and showing a year-over-year increase from $11.85 million [2] Financial Performance - Over the last four quarters, OptiNose has surpassed consensus EPS estimates three times [2] - The company has also topped consensus revenue estimates three times in the same period [2] - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $20.54 million, and for the current fiscal year, it is -$0.26 on revenues of $89.65 million [7] Stock Performance - OptiNose shares have declined approximately 9.3% since the beginning of the year, contrasting with the S&P 500's gain of 9.5% [3] - The stock currently holds a Zacks Rank 2 (Buy), indicating expectations of outperforming the market in the near future [6] Industry Outlook - The Medical - Drugs industry, to which OptiNose belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Performance - Total revenues for the three months ended March 31, 2024, were $14,880,000, an increase of 25.7% compared to $11,846,000 for the same period in 2023[21]. - The net loss for the first quarter of 2024 was $14,067,000, a decrease from a net loss of $18,847,000 in the first quarter of 2023, representing a 25.5% improvement[21]. - The company reported a basic and diluted net loss per share of $0.12 for the first quarter of 2024, compared to $0.17 for the same period in 2023[21]. - Total operating expenses decreased to $22.9 million in Q1 2024 from $26.2 million in Q1 2023, with a net loss of $14.1 million compared to $18.8 million in the prior year[137]. Cash and Liquidity - Cash and cash equivalents decreased to $51,644,000 as of March 31, 2024, down from $73,684,000 at the end of 2023, reflecting a decrease of 30%[19]. - Cash used in operating activities for the first quarter of 2024 was $22,025,000, compared to $10,478,000 in the same period of 2023, indicating an increase in cash outflow[28]. - As of March 31, 2024, the company believes existing cash and cash equivalents, along with net proceeds from a registered direct offering completed on May 10, 2024, will be sufficient to fund operations and debt service obligations through 2025[157]. - The company anticipates requiring additional capital in the future through equity or debt financings, partnerships, or collaborations to meet debt obligations[156]. Expenses - Research and development expenses for the first quarter of 2024 were $1,206,000, down from $1,785,000 in the first quarter of 2023, a reduction of 32.4%[21]. - Selling, general and administrative expenses decreased to $20,518,000 in Q1 2024 from $22,723,000 in Q1 2023, a decline of 9.7%[21]. - Stock-based compensation expense for the three months ended March 31, 2024, totaled $1,456, compared to $1,522 for the same period in 2023[99]. Debt and Liabilities - The company had a total stockholders' deficit of $99,216,000 as of March 31, 2024, compared to a deficit of $86,606,000 at the end of 2023[19]. - The Pharmakon debt balance as of March 31, 2024, was $130,653, classified as long-term due to expected compliance with covenants for at least the next 12 months[90]. - The effective interest rate on the Pharmakon Senior Secured Notes as of March 31, 2024, is 14.80%[79]. - Total current liabilities decreased significantly to $32,705,000 from $176,524,000 at the end of 2023, indicating a reduction of 81.5%[19]. Revenue Recognition and Sales - The Company recognizes revenue from XHANCE sales at the point customers obtain control of the product, which generally occurs upon delivery[48]. - XHANCE generated net product revenues of $14.9 million for Q1 2024, a 26.3% increase from $11.8 million in Q1 2023[124]. - Average net product revenues per prescription for XHANCE were $227 in Q1 2024, representing a 63% increase compared to $139 in Q1 2023[118]. - The total estimated number of XHANCE prescriptions in Q1 2024 was 65,500, a 23% decrease from 85,200 in Q1 2023[118]. Market and Product Development - The FDA approved XHANCE for the treatment of chronic rhinosinusitis without nasal polyps on March 15, 2024, expanding its market opportunity[113]. - The company continues to support the commercialization of XHANCE through advertising, patient affordability programs, and clinical development activities[156]. - The company is evaluating product candidates and may in-license, acquire, or partner in the development of other products or technologies[156]. Inventory and Assets - The company reported a total inventory of $10,315,000 as of March 31, 2024, compared to $8,052,000 as of December 31, 2023, representing an increase of 28.2%[71]. - The Company’s property and equipment, net, was valued at $754,000 as of March 31, 2024, down from $815,000 as of December 31, 2023[73]. Accounting and Compliance - The company has not materially changed its critical accounting policies as reported in its annual Form 10-K for the year ended December 31, 2023[158]. - Recent accounting pronouncements applicable to the company's consolidated financial statements are detailed in the unaudited interim consolidated financial statements[159]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[160].

Financial Performance - XHANCE net revenue for Q1 2024 was $14.9 million, a 26% increase from $11.8 million in Q1 2023[2] - The company reported a net loss of $14.1 million for Q1 2024, or $0.12 per share[11] - Research and development expenses for Q1 2024 were $1.2 million, while selling, general and administrative expenses were $20.5 million[11] - The company expects full year 2024 XHANCE net revenues to be between $85.0 million and $95.0 million[13] - The company expects to achieve positive income from operations (GAAP) for the full year 2025[16] Revenue Projections - The anticipated peak year net revenues for XHANCE are projected to be at least $300 million from the current specialist prescriber audience[4] - XHANCE average net revenue per prescription for 2024 is expected to exceed $230, up from a previous estimate of approximately $220[14] Cash Position - The company completed a registered direct offering expected to result in approximately $55 million of net proceeds, with post-offering cash and cash equivalents projected to be around $100 million[9] - The company had cash and cash equivalents of $51.6 million as of March 31, 2024, not including the expected proceeds from the recent offering[12] Market Expansion - The FDA approved XHANCE as the first prescription medication for chronic rhinosinusitis without nasal polyps in March 2024, significantly expanding the addressable market[4]

YARDLEY, Pa., May 10, 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 first quarter 2024 and corporate updates, before market open, on Tuesday, May 14, 2024. Company to Host Conference CallMembers of the Company's leadership team will host a conference call to discuss financial results and corporate updates. The call is scheduled to st ...

YARDLEY, Pa., May 10, 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 first quarter 2024 and corporate updates, before market open, on Tuesday, May 14, 2024. Company to Host Conference CallMembers of the Company’s leadership team will host a conference call to discuss financial results and corporate updates. The call is scheduled to st ...