OptiNose, Inc. (NASDAQ:OPTN) Q3 2023 Earnings Conference Call November 9, 2023 8:00 AM ET Company Participants Jonathan Neely - Vice President, Investor Relations and Business Development Dr. Ramy Mahmoud - Chief Executive Officer Paul Spence - Chief Commercial Officer Conference Call Participants Thomas Flaten - Lake Street Operator Good day and thank you for standing by. Welcome to OptiNose Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the spe ...

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 September 30, 2023 ☐ 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) (State of other jurisd ...

Financial Data and Key Metrics Changes - In Q2 2023, OptiNose recognized $19.5 million in XHANCE net revenue, a decrease from $20.6 million in Q2 2022, but stronger than initial expectations for the quarter [26] - Total operating expenses, including SG&A and R&D, were $21.1 million in Q2 2023, a decrease of approximately $13 million or 38% compared to $33.8 million in Q2 2022 [26] - First half 2023 revenues were $31.3 million, exceeding initial expectations, leading to an increase in full-year revenue guidance to between $64 million and $70 million [27][33] Business Line Data and Key Metrics Changes - XHANCE prescription demand showed approximately 30,900 new prescriptions in Q2 2023, a 3% increase from Q2 2022, with total prescriptions reaching about 90,700, also a 3% increase [20][21] - The number of physicians prescribing XHANCE increased by 4% year-over-year, with 8,624 physicians having at least one prescription filled [21] - However, the number of physicians with more than 15 prescriptions filled decreased by approximately 6%, now at around 1,400 physicians [22] Market Data and Key Metrics Changes - The company anticipates that the approval of XHANCE for chronic sinusitis could increase the patient base for promotion by at least 10-fold, as chronic sinusitis is diagnosed significantly more frequently than nasal polyps [15][10] - The payer landscape has not materially changed regarding coverage for XHANCE, and the company expects similar coverage dynamics post-label expansion [41][43] Company Strategy and Development Direction - The company is focused on preparing for the potential launch of XHANCE as the first FDA-approved treatment for chronic sinusitis, with a strategic emphasis on reducing cash usage and increasing profitability [14][19] - OptiNose is exploring commercial partnerships to enhance outreach beyond its current specialty segment, aiming to build a profitable ENT and allergy-focused business [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the potential value of XHANCE and the expected growth starting in 2024, contingent on FDA approval [5][10] - The company is actively preparing for the launch, ensuring scalability in pharmacy distribution and refining healthcare provider targeting [56][58] Other Important Information - The FDA is currently reviewing the supplemental new drug application for XHANCE, with a target action date set for mid-December 2023 [12][18] - The company has reduced operating expenses by $22 million or 33% in the first half of 2023 compared to the same period in 2022 [31] Q&A Session Summary Question: Can you speak to the payer landscape and whether it's evolved recently? - Management indicated no material changes in the payer landscape regarding XHANCE coverage for nasal polyps, and they expect similar dynamics post-label expansion [41][43] Question: How do you expect net revenue per prescription to evolve with the upcoming expansion to chronic sinusitis? - Management noted that they do not have guidance for 2024 yet, but they expect revenue per prescription to be approximately $200 for the full year 2023, down from just below $220 in 2022 [45][50] Question: Can you provide additional color on the launch preparedness ahead of the label expansion? - Management highlighted a fresh product positioning approach, scalability of pharmacy distribution, and refining healthcare provider targeting as key components of their launch preparation [55][58]

| --- | --- | --- | |-------|-------|----------------------------------------------| | | | | | | | FDA accepted for review our supplemental new | optinose® Q2 2023 Performance XHANCE New Prescriptions increased 3%, Total Prescriptions increased 3% and HCPs who had a prescription filled by their patients increased 4% from Q2 2022 to Q2 2023 8 XHANCE Prescriptions – Second Quarter 2023 30.1 30.9 Q2 '22 Q2 '23 (in thousands) XHANCE New Prescriptions 87.7 90.7 Q2 '22 Q2 '23 XHANCE Total Prescriptions (in thousa ...

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, 2023 ☐ 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 ...

OptiNose Inc. (NASDAQ:OPTN) Q1 2023 Results Conference Call May 11, 2023 8:00 AM ET Company Participants Jonathan Neely - VP of IR and Business Operations Ramy Mahmoud - CEO and Director Conference Call Participants Brandon Folkes - Cantor Fitzgerald Operator Good day, and thank you for standing by. Welcome to the OptiNose's First Quarter 2023 Earnings Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker today, Jonathan Neely, Vice President, Investor Relatio ...

Financial Performance - Total revenues for the three months ended March 31, 2023, were $11,846,000, a decrease of 19.5% compared to $14,760,000 for the same period in 2022[22]. - Net loss for the three months ended March 31, 2023, was $18,847,000, compared to a net loss of $25,333,000 for the same period in 2022, representing a 25.7% improvement[24]. - The company reported a loss from operations of $14,368,000 for the three months ended March 31, 2023, compared to a loss of $21,395,000 for the same period in 2022, indicating a 32.8% improvement[22]. - Net product revenues for the three months ended March 31, 2023, were $11.8 million, a decrease of 20% from $14.8 million in the same period of 2022[133]. - Total operating expenses decreased to $26.2 million for the three months ended March 31, 2023, down 27.5% from $36.2 million in 2022[132]. - Cash used in operating activities decreased by $8.9 million to $10.5 million for the three months ended March 31, 2023, compared to $19.3 million in 2022[140]. Assets and Liabilities - Cash and cash equivalents at the end of the period were $83,928,000, down from $94,244,000 at the end of 2022, indicating a decrease of 10.4%[21]. - Total current assets decreased to $112,171,000 as of March 31, 2023, from $140,484,000 as of December 31, 2022, reflecting a decline of 20.1%[21]. - Total liabilities decreased to $188,710,000 as of March 31, 2023, from $200,846,000 as of December 31, 2022, a reduction of 6.0%[21]. - As of March 31, 2023, the Company had cash and cash equivalents of $83,928 and a working capital deficiency of $54,132[33]. - The Company has incurred recurring net losses since inception, accumulating a deficit of $703,740 as of March 31, 2023[34]. Expenses - Research and development expenses for the three months ended March 31, 2023, were $1,785,000, down 62.9% from $4,802,000 in the same period of 2022[22]. - Selling, general and administrative expenses decreased to $22,723,000 for the three months ended March 31, 2023, from $29,339,000 in the same period of 2022, a decrease of 22.5%[22]. - For the three months ended March 31, 2023, the total accrued expenses and other current liabilities amounted to $31,080, a decrease from $44,864 as of December 31, 2022, reflecting a reduction of approximately 30.8%[77]. Revenue Recognition - The Company recognizes revenue from XHANCE sales at the point customers obtain control of the product, which generally occurs upon delivery[54]. - The Company is subject to discount obligations under state Medicaid programs and Medicare, with reserves recorded in the same period the related revenue is recognized[57]. - The Company’s total product revenue allowances decreased to $17,236 as of March 31, 2023, from $27,993 as of December 31, 2022, indicating a reduction of approximately 38.4%[77]. Market and Sales - The total estimated number of XHANCE prescriptions in Q1 2023 was 84,400, representing a 1% increase from 83,500 in Q1 2022[109]. - The INS prescription market increased by 5% from Q1 2022 to Q1 2023[109]. - The total estimated number of new prescriptions for XHANCE in Q1 2023 was 30,400, a 3% increase from 29,500 in Q1 2022[116]. - The total estimated number of refill prescriptions for XHANCE in Q1 2023 remained unchanged at 54,000 compared to Q1 2022[116]. - The number of physicians prescribing XHANCE decreased by 6% to 8,545 in Q1 2023 from 8,027 in Q1 2022[116]. - Approximately 80% of commercially insured lives are in a plan that covers XHANCE as of March 31, 2023[116]. Future Outlook - The company expects full year 2023 net product revenues to be between $62.0 million and $68.0 million[119]. - Average net product revenues per prescription for the full year 2023 are expected to be approximately $200[119]. - The company expects total GAAP operating expenses for 2023 to be between $88.0 million and $93.0 million, approximately a $30.0 million reduction compared to 2022[143]. - The company anticipates requiring additional capital in the near term to maintain compliance with financial covenants and fund operations[146]. Compliance and Governance - The Chief Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2023[158]. - There were no changes in internal control over financial reporting during the three months ended March 31, 2023, that materially affected the internal control[159]. - The company entered into amended and restated employment agreements with executive officers on May 9, 2023[161].

☐ 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. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Exact name of registrant as specified in its charter) FORM 10-K ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2022 OR Indicate by check mark if the registran ...

Financial Data and Key Metrics Changes - In Q4 2022, XHANCE net revenue was $20.9 million, a decrease of 7% compared to Q4 2021's $22.5 million [94] - Full-year 2022 XHANCE net revenue was $76.3 million, an increase of 4% compared to the prior year [94] - Average net revenue per prescription for Q4 2022 was $242, an increase of 1% from $240 in Q4 2021 [95] - Full-year 2022 average net revenue per prescription was $224, reflecting a 2% increase from $219 in 2021 [96] - The company expects total operating expenses for 2023 to be between $90 million and $95 million, a reduction of approximately $30 million or 25% compared to $123 million in 2022 [12] Business Line Data and Key Metrics Changes - In Q4 2022, there were approximately 86,200 total prescriptions for XHANCE, an 8% decrease compared to Q4 2021 [90] - For the full year 2022, there were approximately 341,000 total prescriptions for XHANCE, a 2% increase compared to 2021 [90] - The market share of XHANCE was 5.7% in Q4 2022, down from 5.9% in Q4 2021 [91] - The number of physicians who had patients fill at least one prescription for XHANCE increased by 8% to 8,104 in Q4 2022, while the number of physicians with more than 15 prescriptions decreased by 8% to approximately 1,450 [92] Market Data and Key Metrics Changes - The INS market, which includes prescriptions written by any physician for any condition, increased by 4% over the same period [90] - The company believes that the new chronic sinusitis indication could increase the number of patients for whom XHANCE can be promoted by tenfold, as claims data suggests a significantly larger patient population diagnosed with chronic sinusitis compared to nasal polyps [3][4] Company Strategy and Development Direction - The company is refocusing its strategy to prioritize the potential launch of XHANCE as the first FDA-approved drug treatment for chronic rhinosinusitis [11][80] - The company plans to reduce total expenses while concentrating commercial investments on the most productive territories and programs [9] - The company is exploring various ways to reach a larger patient audience, including commercial partnerships and alternative selling models [81][84] Management's Comments on Operating Environment and Future Outlook - Management expressed dissatisfaction with the commercial results in 2022 and emphasized the importance of cash preservation for future investments [86] - The management believes that achieving the chronic sinusitis indication will be crucial for future value creation [18] - The company is actively planning for a successful launch aimed at rapidly making the product available to millions of patients in need [22] Other Important Information - The company has reduced its number of territory managers by approximately 15% at the end of 2022 [12] - The company expects first-quarter 2023 XHANCE net revenue to be approximately $10 million, reflecting a decrease due to expected increases in gross to net deductions and a decrease in units shipped [14] Q&A Session Summary Question: How quickly can you ramp the CS label uptake? - Management indicated that they are preparing for a successful launch and are actively engaging in conversations with potential partners to facilitate this [23][44] Question: What areas need the greatest change in commercial strategy? - Management stated that they are reevaluating all aspects of commercialization and focusing on improving prescription conversion rates and payer access strategies [26][100] Question: What is the urgency to find a primary care partner? - Management acknowledged the urgency to find a primary care partner to access a larger audience, emphasizing the potential benefits of such a partnership [48][55] Question: What is the expected cash burn in 2023? - Management indicated that they expect cash burn to be in the range of $30 million to $40 million for 2023 [120][121] Question: Why not consider a sale of the company? - Management is considering a range of strategic options, including partnerships and maintaining independence, while also evaluating the potential for M&A transactions [39]

OptiNose, Inc. (NASDAQ:OPTN) Q3 2022 Earnings Conference Call November 10, 2022 8:00 AM ET Company Participants Jonathan Neely - VP, IR and Business Development Peter Miller - CEO Ramy Mahmoud - President and COO Conference Call Participants Glenn Santangelo - Jefferies Isaac Somekh - Piper Sandler Gary Nachman - BMO Capital Markets Stacy Ku - Cowen Brandon Folkes - Cantor Jonathan Neely [Starts Abruptly] Third quarter 2022 performance and our plans for the remainder of the year. I'm joined today by our CEO ...