Optinose Reports First Quarter 2024 Financial Results and Recent Operational Highlights
Optinose (NASDAQ:OPTN) reported Q1 2024 net revenue of $14.9 million for XHANCE, marking a 26% increase from Q1 2023. The company forecasts full-year 2024 XHANCE net revenues between $85-$95 million, with peak revenue expectations of at least $300 million. Optinose anticipates positive GAAP income for 2025. In March 2024, the FDA approved XHANCE for chronic rhinosinusitis without nasal polyps, significantly expanding its market. The approval of a second manufacturing site and a $55 million direct offering were also highlighted. Despite these advancements, Q1 2024 saw a net loss of $14.1 million, and operating expenses are projected between $95-$101 million for 2024.
- Q1 2024 XHANCE net revenue increased by 26% to $14.9 million.
- Full-year 2024 XHANCE net revenue forecasted between $85-$95 million.
- Peak year XHANCE net revenue expected to be at least $300 million.
- FDA approval of XHANCE for chronic rhinosinusitis without nasal polyps.
- Approval of a second manufacturing site for XHANCE.
- $55 million direct offering completed, boosting cash reserves to approximately $100 million.
- Positive income from operations anticipated for full year 2025.
- Q1 2024 net loss of $14.1 million, or $0.12 per share.
- Operating expenses for 2024 projected between $95-$101 million.
- $51.6 million in cash and cash equivalents as of March 31, 2024, down from $73.7 million at the end of 2023.
- Total liabilities increased significantly to $182.9 million as of March 31, 2024.
- High selling, general, and administrative expenses at $20.5 million for Q1 2024.
Insights
The financial results for Optinose in Q1 2024 show a significant improvement in net revenue from XHANCE sales, which increased by
However, despite the revenue growth, the company reported a net loss of $14.1 million, which reflects ongoing challenges in managing costs and expenses. The operating expenses for this quarter were high at
The recent $55 million registered direct offering strengthens the company’s cash position, with post-offering cash and equivalents expected to be around
Overall, while the revenue growth is encouraging, the net loss and high expenses are areas of concern. Investors should monitor the company’s cost management strategies and progress toward profitability.
The FDA approval of XHANCE for chronic rhinosinusitis without nasal polyps is a pivotal milestone for Optinose. This approval opens up a significantly larger market, as chronic rhinosinusitis is a common condition with limited prescription treatment options. The company estimates this new indication could increase the total addressable market by up to ten times, which suggests substantial long-term growth potential.
The clinical data published in the Journal of Allergy and Clinical Immunology: In Practice supports the efficacy and safety of XHANCE, showing statistically significant improvements in symptoms, inflammation and reduction in acute disease exacerbations. This peer-reviewed validation enhances the credibility of XHANCE among healthcare professionals and could drive higher adoption rates.
Moreover, the approval of a second manufacturing site ensures a more robust supply chain, mitigating risks associated with production disruptions and allowing the company to scale up to meet increased demand.
However, the challenge lies in effectively educating and engaging both specialists and primary care physicians to maximize this expanded market opportunity. The company’s current focus on specialty prescribers may need to evolve to include a broader prescriber base to fully capitalize on the potential market size.
Optinose’s strategic positioning in the ENT and allergy specialist market is showing positive results, as evidenced by the substantial revenue growth for XHANCE. The recent FDA approval significantly enhances market potential, but to achieve the peak revenue target of
The company’s focus on leveraging its commercial infrastructure for the new indication is a prudent move, but additional marketing efforts will be necessary. The inclusion of primary care physicians in their strategy could be a game-changer, potentially driving broader adoption and higher prescription rates.
The anticipation of positive income from operations by 2025 sets a clear financial target. However, achieving this will depend on not only expanding the market but also managing costs effectively. The high operating expenses currently pose a risk and efforts to optimize these costs will be important for sustainable growth.
Overall, Optinose is well-positioned in a growing market segment with a differentiated product, but execution on market expansion and cost management will be key areas to watch.
Company reports Q1 2024 XHANCE net revenue of
Company expects full year 2024 XHANCE net revenues to be between
Company expects peak year XHANCE net revenues of at least
Company expects to produce positive income from operations (GAAP) for full year 2025
Conference call and webcast to be held today at 10:00 a.m. Eastern Time
YARDLEY, Pa., May 14, 2024 (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 ended March 31, 2024, and provided recent operational highlights.
“We are proud that in March, based on evidence including multiple randomized placebo-controlled trials, XHANCE was approved by the FDA as the first prescription medication proven safe and effective for the large population with chronic rhinosinusitis who do not have nasal polyps. Millions of people can potentially benefit from this landmark approval because, despite being one of the most common diagnoses in adult outpatient medicine, there has never been an approved prescription treatment for Chronic Sinusitis,” stated CEO Ramy Mahmoud, MD, MPH. “We estimate that the new indication grows the total addressable market by up to ten times and, we've launched into the new opportunity with our current commercial infrastructure aimed primarily at specialty prescribers. We believe that approach will produce positive income from operations for full year 2025, and peak year net revenues of at least
First Quarter 2024 and Recent Highlights
XHANCE Supplemental New Drug Application (sNDA)
On March 15, 2024, the U.S. Food and Drug Administration (FDA) approved XHANCE® (fluticasone propionate) in the Exhalation Delivery System™ as the first and only medication indicated for treatment of chronic rhinosinusitis without nasal polyps in adult patients.
Publication of ReOpen Clinical Program Results
In January 2024, peer-reviewed data from the landmark ReOpen program evaluating the efficacy and safety of XHANCE in adult patients with chronic rhinosinusitis (chronic sinusitis) was published online in the Journal of Allergy and Clinical Immunology: In Practice. As detailed in the publication, both trials showed statistically significant improvement in symptoms, in inflammation inside the sinuses, and in the number of acute disease exacerbations that occurred in patients treated with XHANCE compared to patients receiving vehicle combined with the Exhalation Delivery System (EDS-placebo).
FDA Approval of Second Manufacturing Site
In March 2024, the FDA approved Hikma Pharmaceuticals USA Inc.’s affiliate West-Ward Columbus Inc., as an additional manufacturing site for finished XHANCE units for commercial sale and sampling. As a result, there are now two sites approved by the FDA for the manufacturer of finished XHANCE units for commercial sale and sampling.
On May 10, 2024 the Company completed a registered direct offering of its common stock and pre-funded common stock warrants to a group of existing and new institutional investors expected to result in approximately
First Quarter 2024 Financial Results
Total revenues
The Company reported
Costs and expenses and net loss
For the three-month period ended March 31, 2024, research and development expenses were
Balance Sheet
The Company had cash and cash equivalents of
Financial Guidance
XHANCE Net Revenue and Average
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
Net Income from Operations
The Company expects to product positive income from operations (GAAP) for full year 2025.
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 10:00 a.m. Eastern Time today.
Participants may access the conference call live via webcast by visiting the Investors section of Optinose’s website at http://ir.optinose.com/presentations. 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.
| OptiNose, Inc. | ||||||||
| Condensed Consolidated Statement of Operations | ||||||||
| (in thousands, except share and per share data) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| Revenues: | ||||||||
| Net product revenues | ||||||||
| Total revenues | 14,880 | 11,846 | ||||||
| Costs and expenses: | ||||||||
| Cost of product sales | 1,231 | 1,706 | ||||||
| Research and development | 1,206 | 1,785 | ||||||
| Selling, general and administrative | 20,518 | 22,723 | ||||||
| Total costs and expenses | 22,955 | 26,214 | ||||||
| Loss from operations | (8,075 | ) | (14,368 | ) | ||||
| Other expense | 5,992 | 4,479 | ||||||
| Net loss | ) | ) | ||||||
| Net loss per share of common stock, basic and diluted | ) | ) | ||||||
| Weighted average common shares outstanding, basic and diluted | 112,594,852 | 111,774,425 | ||||||
| OptiNose, Inc. | ||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| March 31 | December 31, | |||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| Cash and cash equivalents | ||||||||
| Other assets | 32,063 | 34,045 | ||||||
| Total assets | ||||||||
| Total current liabilities (1) | ||||||||
| Long term liabilities (1) | 150,218 | 17,811 | ||||||
| Total stockholders' equity | (99,216 | ) | (86,606 | ) | ||||
| Total liabilities and stockholders' equity | ||||||||
| (1) – All outstanding debt principal and fees payable upon debt maturity have been classified as a long term liability at March 31, 2024. All outstanding debt principal and fees payable upon debt maturity were classified as a current liability at December 31, 2023. Please refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, 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 X and LinkedIn.
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 U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the potential benefits of XHANCE as the first FDA-approved drug treatment for chronic rhinosinusitis without nasal polyps (also referred to as chronic sinusitis); the potential benefits of XHANCE for the treatment of chronic sinusitis and expanded market opportunities relating thereto; the potential benefits of the Exhalation Delivery System; the Company’s expectation for XHANCE net revenue and average net revenue per prescription for full year 2024; the Company’s expectations for GAAP operating expenses (selling, general and administrative expenses and research & development expenses) and stock-based compensation for 2024; the Company’s expectation that it will product positive net income from operations (GAAP) for full year 2025; the Company’s expectation that peak year XHANCE net revenues will be at least
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
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