YARDLEY, Pa., March 07, 2023 (GLOBE NEWSWIRE) — Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2022, and provided recent operational highlights.
“Our strategic focus for 2023 is on working to secure the first-ever drug approval for patients with chronic sinusitis,” stated CEO Ramy Mahmoud, MD, MPH. “This year, we are also preparing our organization for that future opportunity by taking actions to increase the efficiency of our current business and to prepare for a successful launch aimed at rapidly making the product available to millions of patients in need.”
Fourth Quarter 2022 and Recent Highlights
Chronic Sinusitis Supplemental New Drug Application (sNDA)
On February 16th, the Company submitted a supplemental New Drug Application for XHANCE® (fluticasone propionate) Exhalation Delivery System™ seeking a new indication for treatment of adults with chronic rhinosinusitis to the U.S. Food and Drug Administration (FDA). The company anticipates a submission acceptance decision by FDA by the start of May 2023. Assuming acceptance and a standard review period the Company expects the FDA’s PDUFA action date to be in December 2023.
Scientific Meeting Presentations
Data from the landmark ReOpen program evaluating the efficacy and safety of XHANCE in adult patients with chronic sinusitis was presented at IDWeek 2022 on October 21, 2022 and at the American College of Asthma, Allergy and Immunology (ACAAI) 2022 Annual Scientific Meeting on November 12, 2022.
Fourth Quarter and Full Year 2022 Financial Results
Revenue
The Company reported $20.9 million in net revenue from sales of XHANCE during the three-month period ended December 31, 2022, a decrease of 7% compared to $22.5 million during the three-month period ended December 31, 2021. This decrease was primarily driven by a decrease in prescription volumes. For the twelve-month period ended December 31, 2022, the Company reported $76.3 million in net revenue from sales of XHANCE, an increase of 4% compared to $73.7 million during the twelve-month period ended December 31, 2021.
Expenses and net loss
For the three-month and twelve-month periods ended December 31, 2022, research and development expenses were $2.9 million and $15.3 million, respectively. Selling, general and administrative expenses were $23.3 million and $107.6 million during the three-month and twelve-month periods ended December 31, 2022, respectively. The net loss for the three-month period ended December 31, 2022 was $15.1 million, or $0.17 per share (basic and diluted). The net loss for the twelve-month period ended December 31, 2022 was $74.8 million, or $0.87 per share (basic and diluted).
Cash
The Company had cash and cash equivalents of $94.2 million as of December 31, 2022.
Corporate Guidance
Operating Expenses
The Company has prioritized the potential launch of XHANCE as a treatment for chronic sinusitis and will reduce total GAAP operating expenses for full year 2023 compared to full year 2022 by approximately $30.0 million or 25%. Approximately half of the $30.0 million reduction is attributable to sales and marketing and the remainder is attributable to reduced research and development, and general and administrative expenses. As part of actions intended to reduce total operating expenses for full year 2023 the Company reduced its number of territory managers by approximately 15% at the end of 2022. As a result of these actions, the Company expects total GAAP operating expenses for 2023 to be in the range of $90.0 to $95.0 million, of which the Company expects stock-based compensation to be approximately $8.0 million.
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2023 to be between $62.0 to $68.0 million. XHANCE net revenues attributable to a launch as a treatment for patients with chronic sinusitis are not assumed in the full year 2023 guidance range. In addition, the Company’s expectation for full year 2023 XHANCE net revenues includes its expectation that first quarter 2023 XHANCE net revenues will be approximately $10.0 million. The Company expects XHANCE average net revenue per prescription to be approximately $200 for full year 2023.
| OptiNose, Inc. | |||||||||||||||
| Condensed Consolidated Statement of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Revenues: | |||||||||||||||
| Net product revenues | $ | 20,856 | $ | 22,509 | $ | 76,276 | $ | 73,652 | |||||||
| Licensing revenues | — | — | — | 1,000 | |||||||||||
| Total revenues | 20,856 | 22,509 | 76,276 | 74,652 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Cost of product sales | 2,981 | 2,575 | 9,263 | 9,151 | |||||||||||
| Research and development | 2,921 | 5,260 | 15,260 | 25,318 | |||||||||||
| Selling, general and administrative | 23,310 | 26,340 | 107,649 | 106,633 | |||||||||||
| Total costs and expenses | 29,212 | 34,175 | 132,172 | 141,102 | |||||||||||
| Loss from operations | (8,356 | ) | (11,666 | ) | (55,896 | ) | (66,450 | ) | |||||||
| Other expense | 6,793 | 3,958 | 18,937 | 15,846 | |||||||||||
| Net loss | $ | (15,149 | ) | $ | (15,624 | ) | $ | (74,833 | ) | $ | (82,296 | ) | |||
| Net loss per share of common stock, basic and diluted | $ | (0.17 | ) | $ | (0.23 | ) | $ | (0.87 | ) | $ | (1.45 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 94,960.91 | 67,831,835 | 85,900,139 | 56,851,921 | |||||||||||
| OptiNose, Inc. | ||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Cash and cash equivalents | $ | 94,244 | $ | 110,502 | ||||
| Other assets | 49,978 | 55,569 | ||||||
| Total assets | $ | 144,222 | $ | 166,071 | ||||
| Total current liabilities (1) | 178,729 | $ | 59,235 | |||||
| Long-term debt, net | — | 126,418 | ||||||
| Other liabilities | 22,116 | 2,190 | ||||||
| Total stockholders’ equity | (56,623 | ) | (21,772 | ) | ||||
| Total liabilities and stockholders’ equity | $ | 144,222 | $ | 166,071 | ||||
| (1) – The principal balance of our loan payable has been classified as a current liability in accordance with Generally Accepted Accounting Principals (“GAAP”) because the Company believes that it is probable that it will not be able to maintain compliance with certain financial and liquidity covenants contained in the Note Purchase Agreement for at least the next 12-months. As a result, the Company’s audited financial statements for the year ended December 31, 2022 (“2022 Audited Financial Statements”) will state that there is substantial doubt about the Company’s ability to continue as a going concern (i.e., a “going concern” paragraph). Please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (including the 2022 Audited Financial Statements) which will be filed after the issuance of this press release for additional information. | ||||||||
About Optinose
Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
