Optinose Reports Second Quarter 2024 Financial Results and Recent Operational Highlights
Company reports Q2 2024 XHANCE net revenue of $20.5 million, an increase of 5% compared to Q2 2023
XHANCE has been added to Express Scripts’ national formularies, among the largest commercial formularies in the
Company narrows full year 2024 XHANCE net revenue guidance to be between
Conference call and webcast to be held today at
“This is the first quarter in which we are executing on the launch of our new first-and-only label indication for chronic sinusitis, also called chronic rhinosinusitis without nasal polyps, which gives us access to a greatly expanded total addressable market,” stated CEO Ramy Mahmoud, MD, MPH. “We believe the addition of XHANCE to Express Scripts preferred formularies late in the second quarter is an example of gradually improving insurance barriers with our new first-and-only approval. Improving insurance barriers, in conjunction with consistent efforts to disseminate highly differentiated clinical results to both old and new prescribers, are important enablers of our future revenue growth trajectory."
Second Quarter 2024 and Recent Highlights
Improved Formulary Access
In
On
Second Quarter 2024 Financial Results
Total revenues
The Company reported
Costs and expenses and net loss
For the three-month and six-month periods ended
The net loss for the three-month period ended
Balance Sheet
The Company had cash and cash equivalents of
Financial Guidance
XHANCE Net Revenue
The Company expects XHANCE net revenues for the full year of 2024 to be between
XHANCE Average Net Revenue per Prescription
The Company expects full year 2024 XHANCE average net revenue per prescription to exceed
Operating Expenses
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2024 to be between
Company to Host Conference Call
Members 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 at http://ir.optinose.com/event-calendar. To participate via telephone, please register in advance at this 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 | Six Months Ended | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product revenues | $ | 20,490 | $ | 19,454 | $ | 35,370 | $ | 31,299 | ||||||||
| Total revenues | 20,490 | 19,454 | 35,370 | 31,299 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product sales | $ | 1,981 | $ | 2,571 | $ | 3,212 | $ | 4,277 | ||||||||
| Research and development | 928 | 951 | 2,134 | 2,736 | ||||||||||||
| Selling, general and administrative | 24,129 | 20,104 | 44,647 | 42,828 | ||||||||||||
| Total costs and expenses | 27,038 | 23,626 | 49,993 | 49,841 | ||||||||||||
| Loss from operations | (6,548 | ) | (4,172 | ) | (14,623 | ) | (18,542 | ) | ||||||||
| Other (income) expense | 1,033 | (6,798 | ) | 7,026 | (2,318 | ) | ||||||||||
| Net (loss) income | $ | (7,581 | ) | $ | 2,626 | $ | (21,649 | ) | $ | (16,224 | ) | |||||
| Less: undistributed earnings to participating shareholders | — | (53 | ) | — | — | |||||||||||
| Net (loss) income - basic | $ | (7,581 | ) | $ | 2,573 | $ | (21,649 | ) | $ | (16,224 | ) | |||||
| Net income (loss) per share of common stock - basic | $ | (0.05 | ) | $ | 0.02 | $ | (0.17 | ) | $ | (0.15 | ) | |||||
| Weighted average common shares outstanding - basic | 147,455,374 | 111,979,778 | 130,025,113 | 111,877,669 | ||||||||||||
| Net (loss) income - basic | $ | (7,581 | ) | $ | 2,573 | $ | (21,649 | ) | $ | (16,224 | ) | |||||
| Add: Unrealized gain on the fair value of warrants | (3,100 | ) | — | (1,800 | ) | — | ||||||||||
| Net (loss) income - diluted | $ | (10,681 | ) | $ | 2,573 | $ | (23,449 | ) | $ | (16,224 | ) | |||||
| Net income (loss) per share of common stock - diluted | $ | (0.07 | ) | $ | 0.02 | $ | (0.17 | ) | $ | (0.15 | ) | |||||
| Weighted average common shares outstanding - diluted | 150,698,374 | 112,042,097 | 136,918,539 | 111,877,669 | ||||||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | $ | 91,358 | $ | 73,684 | ||||
| Other assets | 40,514 | 34,045 | ||||||
| Total assets | $ | 131,872 | $ | 107,729 | ||||
| Total current liabilities(1) | $ | 32,700 | $ | 176,524 | ||||
| Long term liabilities(1) | 142,025 | 17,811 | ||||||
| Total stockholders' equity | (42,853 | ) | (86,606 | ) | ||||
| Total liabilities and stockholders' equity | $ | 131,872 | $ | 107,729 | ||||
| (1) – All outstanding debt principal and fees payable upon debt maturity have been classified as a long term liability at |
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About
About XHANCE
XHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (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 see full Prescribing Information, including Instructions for Use
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
Optinose Investor Contact
jonathan.neely@optinose.com
267.521.0531
Source: Optinose, Inc.
