Optinose Reports Third Quarter 2024 Financial Results and Recent Operational Highlights
OPTN 11.12.2024
Drug:XHANCE-OPTN XHANCE
Date of Upcoming Event:2024-11-12
Name of Upcoming Event:Conference call and webcast
Company reports Q3 2024 XHANCE net revenue of
Company reports positive inflection in new prescriptions of XHANCE starting in September
Company decreases full year 2024 XHANCE net revenue guidance to be between
Company decreases full year 2024 operating expenses guidance to be between
Conference call and webcast to be held today at
“While our revenue in third quarter was not in line with our expectations, we believe that we are now observing a clear inflection in new prescription demand," stated CEO Ramy Mahmoud, MD, MPH. "We believe the recent accelerating trend in new prescription demand reinforces the magnitude of the longer-term opportunity. In addition, we believe that our experience in the initial phases of the launch has improved our understanding of the key drivers of adoption and that this experience will help support achievement of our peak year objective."
Third Quarter 2024 and Recent Highlights
New Prescriptions (NRx)The four-week moving average of weekly NRx ranged between approximately 1,760 to 1,960 for the weeks ended
Third Quarter 2024 Financial Results
Total revenuesThe Company reported
Costs and expenses and net lossFor the three-month and nine-month periods ended
The net income for the three-month period ended
Balance SheetThe Company had cash and cash equivalents of
Financial Guidance
XHANCE Net RevenueThe Company expects XHANCE net revenues for the full year of 2024 to be between
XHANCE Average Net Revenue per PrescriptionThe Company expects full year 2024 XHANCE average net revenue per prescription to be approximately
Operating ExpensesThe Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2024 to be between
Company to Host Conference CallMembers of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at
Participants may access the conference call live via webcast by visiting the Investors section of Optinose’s website athttp://ir.optinose.com/presentations. To participate via telephone, please register in advance atthis link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a personal PIN that can be used to access the call. In addition, a replay of the webcast will be available on the Company website for 60 days following the event.
| Condensed Consolidated Statement of Operations | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product revenues | $ | 20,437 | $ | 19,823 | $ | 55,807 | $ | 51,122 | ||||||||
| Total revenues | 20,437 | 19,823 | 55,807 | 51,122 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product sales | $ | 2,065 | $ | 2,225 | $ | 5,277 | $ | 6,502 | ||||||||
| Research and development | 949 | 1,281 | 3,083 | 4,017 | ||||||||||||
| Selling, general and administrative | 19,475 | 18,011 | 64,121 | 60,839 | ||||||||||||
| Total costs and expenses | 22,489 | 21,517 | 72,481 | 71,358 | ||||||||||||
| Loss from operations | (2,052 | ) | (1,694 | ) | (16,674 | ) | (20,236 | ) | ||||||||
| Other (income) expense | (2,519 | ) | 7,600 | 4,507 | 5,280 | |||||||||||
| Net income (loss) | $ | 467 | $ | (9,294 | ) | $ | (21,181 | ) | $ | (25,516 | ) | |||||
| Less: undistributed earnings to participating shareholders | (74 | ) | — | — | — | |||||||||||
| Net income (loss) - basic | $ | 393 | $ | (9,294 | ) | $ | (21,181 | ) | $ | (25,516 | ) | |||||
| Net income (loss) per share of common stock - basic | $ | — | $ | (0.08 | ) | $ | (0.15 | ) | $ | (0.23 | ) | |||||
| Weighted average common shares outstanding - basic | 174,328,570 | 112,230,155 | 144,900,726 | 111,996,456 | ||||||||||||
| Net income (loss) - basic | $ | 393 | $ | (9,294 | ) | $ | (21,181 | ) | $ | (25,516 | ) | |||||
| Add: Unrealized gain on the fair value of warrants | — | — | (8,700 | ) | — | |||||||||||
| Net income (loss) - diluted | $ | 393 | $ | (9,294 | ) | $ | (29,881 | ) | $ | (25,516 | ) | |||||
| Net income (loss) per share of common stock - diluted | $ | — | $ | (0.08 | ) | $ | (0.20 | ) | $ | (0.23 | ) | |||||
| Weighted average common shares outstanding - diluted | 174,369,875 | 112,230,155 | 149,634,133 | 111,996,456 | ||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 82,497 | $ | 73,684 | ||||
| Other assets | 48,523 | 34,045 | ||||||
| Total assets | $ | 131,020 | $ | 107,729 | ||||
| Total current liabilities(1) | $ | 162,430 | $ | 176,524 | ||||
| Other liabilities | 9,687 | 17,811 | ||||||
| Total stockholders' equity | (41,097 | ) | (86,606 | ) | ||||
| Total liabilities and stockholders' equity | $ | 131,020 | $ | 107,729 | ||||
| (1) – All outstanding principal and fees payable upon maturity have been classified as a current liability in accordance with Generally Accepted Accounting Principles ("GAAP") because, as of the date hereof, the Company believes that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months. As a result, the Company's unaudited financial statements for the three and nine months ended | ||||||||
About
About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery SystemTM (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred.
- Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.
- Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
- Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
- Assess for decrease in bone mineral density initially and periodically thereafter.
ADVERSE REACTIONS:
- Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.
- Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.
DRUG INTERACTIONS:Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS:Hepatic impairment. Monitor patients for signs of increased drug exposure.Please seefull Prescribing Information, including Instructions for Use.
Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the
Optinose Investor Contact
Source: Optinose, Inc.