OptiNose(OPTN)

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OptiNose(OPTN) - 2023 Q4 - Earnings Call Presentation
2024-03-07 14:15
Corporate Presentation March 7, 2024 Forward-looking statements are based upon management's current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: impact of, and the uncertainties caused by, physician and patient acceptance of XHANCE for its current and any potential future indication; our ability to ...
OptiNose(OPTN) - 2023 Q4 - Earnings Call Transcript
2024-03-07 14:14
Financial Data and Key Metrics Changes - OptiNose recognized $19.9 million of XHANCE net revenue in Q4 2023, a 5% decrease compared to Q4 2022 net revenues of $20.9 million [12] - For the full year 2023, XHANCE net revenue was $71 million, with an average net revenue per prescription of $209, reflecting a strategic focus on profitability [13][30] - Operating expenses were reduced by $38 million or 31% for the full year 2023 compared to 2022, with significant savings in SG&A [13][29] Business Line Data and Key Metrics Changes - There were approximately 115,000 new prescriptions for XHANCE and 339,000 total prescriptions in 2023, both showing low single-digit percentage decreases compared to 2022 [10] - The average net revenue per prescription increased to $250 in Q4 2023, an 11% increase from $226 in Q4 2022 [30] Market Data and Key Metrics Changes - The company anticipates first quarter 2024 XHANCE net revenues to be approximately $13 million, a 10% increase compared to Q1 2023 [51] - The total addressable market for chronic sinusitis patients is estimated to be between $10 million to $12 million, with one-third of that population cared for in the specialty universe [42] Company Strategy and Development Direction - The company aims to build a profitable ENT and allergy-focused business by leveraging expanded net revenue potential through existing commercial capabilities [6][53] - The supplemental new drug application for XHANCE is under FDA review, with a target action date set for March 16, 2024, which could significantly reshape the business [22][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of XHANCE as the first prescription treatment for chronic sinusitis, which could increase the patient base significantly [21][22] - The company is focused on optimizing its sales force and distribution strategy to better align with the chronic sinusitis opportunity [9][16] Other Important Information - The company reported a cash position of $73.7 million as of December 31, 2023, indicating a solid financial foundation for future operations [50] - Adjustments to the co-pay assistance program were made to enhance profitability by reducing unprofitable prescriptions [9][30] Q&A Session Summary Question: Can you provide more detail on the sales force and distribution optimization? - The company has realigned its 75 sales territories to focus on the chronic sinusitis opportunity, aiming to reach high-prescribing physicians in that specialty [16][54] Question: What portion of the opportunity can be accessed with existing infrastructure? - The total addressable market for activated patients is estimated at $10 million to $12 million, with about one-third of that population in the specialty universe [42] Question: How has the dialogue with payers been regarding access improvements? - Current contracts with payers are transparent about the pending application for chronic sinusitis, and the company is optimistic about improved access if the label expansion is approved [55]
OptiNose(OPTN) - 2023 Q4 - Annual Report
2024-03-07 12:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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, 2023 OR ☐ 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 of other jur ...
OptiNose(OPTN) - 2023 Q4 - Annual Results
2024-03-07 12:00
[Optinose Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights](index=1&type=section&id=Optinose%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Recent%20Operational%20Highlights) This report details Optinose's financial performance for Q4 and full year 2023, alongside key operational advancements for XHANCE [Operational Highlights](index=1&type=section&id=Operational%20Highlights) Optinose focuses on securing FDA approval for a new XHANCE indication for chronic sinusitis, targeting a market ten times larger than its current use - The FDA accepted the supplemental New Drug Application (sNDA) for XHANCE for chronic sinusitis, with a PDUFA target action date of **March 16, 2024**[1](index=1&type=chunk)[4](index=4&type=chunk) - The company is prepared for a rapid launch of XHANCE for this new indication if approved, targeting a market where physicians diagnose chronic sinusitis **10 times more frequently** than the current nasal polyps indication[1](index=1&type=chunk)[3](index=3&type=chunk) - Data from the ReOpen clinical program, published in a peer-reviewed journal, showed statistically significant improvement in symptoms and inflammation for patients treated with XHANCE compared to a placebo[5](index=5&type=chunk) [Fourth Quarter and Full Year 2023 Financial Results](index=1&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results) For the full year 2023, Optinose reported a **7% decrease** in XHANCE net revenue to **$71.0 million**, while significantly reducing operating expenses by **31%**, leading to a smaller net loss of **$35.5 million** [Revenue](index=1&type=section&id=Revenue) XHANCE net revenue decreased in both the fourth quarter and the full year of 2023 compared to the same periods in 2022, primarily due to lower product shipments XHANCE Net Revenue (in millions) | Period | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | **Fourth Quarter** | $19.9 | $20.9 | -5% | | **Full Year** | $71.0 | $76.3 | -7% | [Costs, Expenses, and Net Loss](index=2&type=section&id=Costs%20and%20Expenses%20and%20net%20%28loss%29%20income) The company achieved a significant **31% reduction** in combined R&D and SG&A expenses for the full year 2023, totaling **$85.1 million**, contributing to a smaller net loss of **$35.5 million** - Total SG&A plus R&D expenses for FY 2023 decreased by **$37.8 million**, or **31%**, to **$85.1 million** compared to **$122.9 million** in FY 2022[7](index=7&type=chunk) Net Loss and EPS (Full Year) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | **Net Loss** | $(35.5) million | $(74.8) million | | **Net Loss per Share** | $(0.32) | $(0.87) | [Balance Sheet](index=2&type=section&id=Balance%20Sheet) As of December 31, 2023, Optinose had cash and cash equivalents of **$73.7 million** - The company's cash and cash equivalents stood at **$73.7 million** at the end of 2023[9](index=9&type=chunk) [Corporate Guidance](index=2&type=section&id=Corporate%20Guidance) Optinose provided financial guidance, expecting XHANCE net revenues of approximately **$13.0 million** for Q1 2024 and an average net revenue per prescription of approximately **$220** for the full year 2024 - Expects XHANCE net revenues for Q1 2024 to be approximately **$13.0 million**[10](index=10&type=chunk) - Projects XHANCE average net revenue per prescription will be approximately **$220** for the full year 2024[11](index=11&type=chunk) [Condensed Consolidated Financial Statements](index=3&type=section&id=Condensed%20Consolidated%20Financial%20Statements) The unaudited financial statements detail the company's performance, showing a reduced net loss and disclosing a probable inability to comply with debt covenants, which will result in a "going concern" paragraph [Condensed Consolidated Statement of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) For the year ended December 31, 2023, total revenues were **$71.0 million** and total costs and expenses were **$93.7 million**, resulting in a net loss of **$35.5 million**, a significant improvement from 2022 Statement of Operations (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Total revenues** | $70,987 | $76,276 | | **Total costs and expenses** | $93,735 | $132,172 | | **Loss from operations** | $(22,748) | $(55,896) | | **Net loss** | $(35,483) | $(74,833) | | **Net loss per share** | $(0.32) | $(0.87) | [Condensed Consolidated Balance Sheet Data](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) As of December 31, 2023, the company had **$73.7 million** in cash and cash equivalents, total assets of **$107.7 million**, and total liabilities of **$194.3 million**, resulting in a stockholders' deficit of **$86.6 million** Balance Sheet Data (in thousands) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $73,684 | $94,244 | | **Total assets** | $107,729 | $144,222 | | **Total liabilities** | $194,335 | $200,845 | | **Total stockholders' equity** | $(86,606) | $(56,623) | - The company's 2023 audited financial statements will include a "going concern" paragraph, as it is probable that the company will not be able to maintain compliance with certain debt covenants[17](index=17&type=chunk) [About XHANCE and Safety Information](index=4&type=section&id=About%20XHANCE%20and%20Safety%20Information) XHANCE is a drug-device combination product for chronic rhinosinusitis with nasal polyps, under review for chronic sinusitis, with important safety warnings including local nasal adverse reactions and immunosuppression - XHANCE uses the Exhalation Delivery System (EDS) to deliver a topical anti-inflammatory to high and deep regions of the sinonasal cavity[19](index=19&type=chunk) - Key warnings include local nasal adverse reactions (epistaxis, ulceration, perforation), impaired wound healing, risk of glaucoma/cataracts, immunosuppression, and potential for hypercorticism[25](index=25&type=chunk) - The most common adverse reactions (≥3% incidence) are epistaxis, nasal septal ulceration, nasopharyngitis, and headache[22](index=22&type=chunk) [Cautionary Note on Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements) This section outlines forward-looking statements concerning XHANCE's potential approval and launch, and financial projections, cautioning that actual results could differ materially due to various risks - Forward-looking statements relate to the potential FDA approval of XHANCE for chronic sinusitis, launch preparations, and financial projections for Q1 and full-year 2024[26](index=26&type=chunk) - Key risks include the company's ability to comply with debt covenants, its ability to continue as a going concern, physician and patient acceptance of XHANCE, and uncertainties related to regulatory approval[26](index=26&type=chunk)
OptiNose(OPTN) - 2023 Q3 - Earnings Call Presentation
2023-11-09 15:04
Financial Performance & Guidance - Q3 2023 XHANCE net revenues reached $198 million[18], supporting an increase to FY 2023 expectations[18] - Full Year 2023 XHANCE net revenues are expected to be between $66 million and $70 million[1, 48] - SG&A plus R&D expenses decreased by approximately $9 million from Q3 2022 to Q3 2023[18] - Year-to-date September 2023 XHANCE net revenues totaled $511 million[45, 59], exceeding initial expectations[59] - Year-to-date September 2023 SG&A plus R&D expenses decreased by approximately $32 million compared to the same period in 2022[59] - The company held $668 million in cash as of September 30, 2023[36] Prescription Trends - Q3 2023 total XHANCE prescriptions reached 841 thousand[16] - Q3 2023 new XHANCE prescriptions reached 274 thousand[16], a decrease of 4%[31] - Year-to-date September 2023 total XHANCE prescriptions reached 2600 thousand[26], an increase of 1%[58] - Year-to-date September 2023 new XHANCE prescriptions reached 888 thousand[26], an increase of 1%[58] Clinical & Regulatory Updates - The FDA accepted the supplemental new drug application (sNDA) for review, targeting a new indication[14] - The PDUFA target action date for the sNDA is December 16, 2023[14]
OptiNose(OPTN) - 2023 Q3 - Quarterly Report
2023-11-09 12:03
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 ...
OptiNose(OPTN) - 2023 Q2 - Earnings Call Transcript
2023-08-10 16:23
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]
OptiNose(OPTN) - 2023 Q2 - Earnings Call Presentation
2023-08-10 14:50
| --- | --- | --- | |-------|-------|----------------------------------------------| | | | | | | | 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 ...
OptiNose(OPTN) - 2023 Q2 - Quarterly Report
2023-08-10 11:11
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(OPTN) - 2023 Q1 - Earnings Call Transcript
2023-05-11 21:57
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 ...