OptiNose(OPTN) - 2023 Q4 - Annual Results

Optinose Fourth Quarter and Full Year 2023 Financial Results and Recent Operational Highlights This report details Optinose's financial performance for Q4 and full year 2023, alongside key operational advancements for XHANCE Operational Highlights 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][4] - 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][3] - 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] Fourth Quarter and Full Year 2023 Financial Results 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 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 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] 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 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] Corporate Guidance 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] - Projects XHANCE average net revenue per prescription will be approximately $220 for the full year 2024[11] Condensed Consolidated Financial Statements 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 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 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] About XHANCE and Safety Information 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] - Key warnings include local nasal adverse reactions (epistaxis, ulceration, perforation), impaired wound healing, risk of glaucoma/cataracts, immunosuppression, and potential for hypercorticism[25] - The most common adverse reactions (≥3% incidence) are epistaxis, nasal septal ulceration, nasopharyngitis, and headache[22] Cautionary Note on Forward-Looking Statements 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] - 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]