Optinose Reports Second Quarter 2024 Financial Results and Recent Operational Highlights
Optinose (NASDAQ:OPTN) reported Q2 2024 financial results, with XHANCE net revenue of $20.5 million, a 5% increase from Q2 2023. The company narrowed its full-year 2024 XHANCE net revenue guidance to $85.0-$90.0 million and increased expected average net revenue per prescription to at least $250. Notably, XHANCE was added to Express Scripts' national formularies, covering over 24 million lives. Optinose completed a $55 million registered direct offering, extending its cash runway through 2025. The company reported a net loss of $7.6 million for Q2 2024. Optinose continues to focus on its new first-and-only label indication for chronic sinusitis, which expands its total addressable market.
Optinose (NASDAQ:OPTN) ha riportato i risultati finanziari del secondo trimestre 2024, con entrate nette da XHANCE di 20,5 milioni di dollari, un aumento del 5% rispetto al Q2 2023. L'azienda ha ristretto le sue previsioni di entrate nette per l'intero anno 2024 da XHANCE a 85,0-90,0 milioni di dollari e ha aumentato le entrate nette medie per prescrizione previste ad almeno 250 dollari. In particolare, XHANCE è stato aggiunto ai formulari nazionali di Express Scripts, coprendo oltre 24 milioni di vite. Optinose ha completato un offerta diretta registrata di 55 milioni di dollari, estendendo la sua disponibilità di liquidità fino al 2025. L'azienda ha segnalato una perdita netta di 7,6 milioni di dollari per il secondo trimestre 2024. Optinose continua a concentrarsi sulla sua nuova indicazione esclusiva per la sinusite cronica, che amplia il suo mercato totale indirizzabile.
Optinose (NASDAQ:OPTN) informó los resultados financieros del segundo trimestre de 2024, con ingresos netos de XHANCE de 20,5 millones de dólares, lo que representa un aumento del 5% en comparación con el Q2 de 2023. La compañía ajustó su guía de ingresos netos para el año completo 2024 de XHANCE a 85,0-90,0 millones de dólares y aumentó los ingresos netos promedio esperados por receta a al menos 250 dólares. Notablemente, XHANCE fue agregado a los formularios nacionales de Express Scripts, cubriendo a más de 24 millones de vidas. Optinose completó una oferta directa registrada de 55 millones de dólares, extendiendo su liquidez hasta 2025. La compañía reportó una pérdida neta de 7,6 millones de dólares para el segundo trimestre de 2024. Optinose sigue enfocado en su nueva y exclusiva indicación para la sinusitis crónica, lo que amplía su mercado objetivo total.
Optinose (NASDAQ:OPTN)는 2024년 2분기 재무 결과를 보고했으며, XHANCE 순수익 2,050만 달러로 2023년 2분기 대비 5% 증가했습니다. 회사는 전체 연도 2024 XHANCE 순수익 가이던스를 8,500만-9,000만 달러로 좁혔고, 처방전당 예상 평균 순수익을 최소 250달러로 증가시켰습니다. 특히, XHANCE는 Express Scripts의 국가 약제 목록에 추가되었습니다, 2400만 이상의 생명을 보장합니다. Optinose는 5,500만 달러의 등록된 직접 공모를 완료하여 2025년까지 현금 운영을 연장했습니다. 회사는 2024년 2분기 동안 760만 달러의 순손실을 보고했습니다. Optinose는 만성 부비동염에 대한 새로운 첫 번째 및 유일한 라벨 적응증에 계속 집중하고 있으며, 이는 총 주소 가능한 시장을 확장합니다.
Optinose (NASDAQ:OPTN) a annoncé les résultats financiers du deuxième trimestre 2024, avec des revenus nets XHANCE de 20,5 millions de dollars, soit une augmentation de 5 % par rapport au Q2 2023. L'entreprise a réduit ses prévisions de revenus nets pour l'année complète 2024 pour XHANCE à 85,0-90,0 millions de dollars et a augmenté les revenus nets moyens attendus par ordonnance à au moins 250 dollars. Notamment, XHANCE a été ajouté aux formulaires nationaux d'Express Scripts, couvrant plus de 24 millions de vies. Optinose a réalisé une offre directe enregistrée de 55 millions de dollars, prolongeant sa trésorerie jusqu'en 2025. L'entreprise a signalé une perte nette de 7,6 millions de dollars pour le deuxième trimestre 2024. Optinose continue de se concentrer sur sa nouvelle indication exclusive pour la sinusite chronique, ce qui élargit son marché adressable total.
Optinose (NASDAQ:OPTN) berichtete über die finanziellen Ergebnisse des 2. Quartals 2024, mit netto Einnahmen von XHANCE in Höhe von 20,5 Millionen US-Dollar, was einem Anstieg von 5 % im Vergleich zum 2. Quartal 2023 entspricht. Das Unternehmen hat seine Prognose für die netto Einnahmen von XHANCE für das gesamte Jahr 2024 auf 85,0-90,0 Millionen US-Dollar eingegrenzt und die erwarteten durchschnittlichen netto Einnahmen pro Rezept auf mindestens 250 US-Dollar erhöht. Bemerkenswerterweise wurde XHANCE in die nationalen Formulare von Express Scripts aufgenommen, die über 24 Millionen Lebensversicherungen abdecken. Optinose hat eine registrierte Direktplatzierung in Höhe von 55 Millionen US-Dollar abgeschlossen, wodurch die finanzielle Handlungsfreiheit bis 2025 verlängert wird. Das Unternehmen meldete einen netto Verlust von 7,6 Millionen US-Dollar für das 2. Quartal 2024. Optinose konzentriert sich weiterhin auf seine neue, erste und einzige Indikation für chronische Sinusitis, die seinen insgesamt adressierbaren Markt erweitert.
- XHANCE net revenue increased by 5% to $20.5 million in Q2 2024
- XHANCE added to Express Scripts' national formularies, covering over 24 million lives
- Completed $55 million registered direct offering, extending cash runway through 2025
- Increased expected average net revenue per prescription guidance to at least $250
- Net loss of $7.6 million in Q2 2024
- Narrowed full-year 2024 XHANCE net revenue guidance from $85-$95 million to $85-$90 million
- Increased selling, general and administrative expenses by $4.0 million compared to Q2 2023
Insights
Optinose's Q2 2024 results show modest growth but raise some concerns. XHANCE net revenue increased by 5% to
However, the company narrowed its full-year revenue guidance to
The
The addition of XHANCE to Express Scripts' national formularies is a significant development, potentially improving access for over 24 million lives. This could be a game-changer for Optinose, as improved insurance coverage often translates to increased prescriptions and revenue.
The new chronic sinusitis indication expands XHANCE's total addressable market substantially. However, the
The increased guidance for average net revenue per prescription (from
The approval of XHANCE as the first and only FDA-approved treatment for chronic rhinosinusitis without nasal polyps (CRSsNP) is a significant medical breakthrough. This condition affects millions of patients and previously lacked targeted pharmacological options.
The company's strategy of disseminating clinical results to prescribers is crucial. ENT and allergy specialists need to understand XHANCE's efficacy in this new indication to drive adoption. The
The reduction in R&D expenses (
Company reports Q2 2024 XHANCE net revenue of
XHANCE has been added to Express Scripts’ national formularies, among the largest commercial formularies in the U.S. with more than 24 million lives
Company narrows full year 2024 XHANCE net revenue guidance to be between
Conference call and webcast to be held today at 8:00 a.m. Eastern Time
YARDLEY, Pa., Aug. 08, 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 June 30, 2024, and provided recent operational highlights.
“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 June 2024, the Company announced that XHANCE® has been added to Express Scripts’ national formularies, including the National Preferred, Flex, and Basic formularies, among the largest commercial formularies in the U.S. with more than 24 million lives.
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 that resulted in approximately
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 June 30, 2024, research and development expenses were
The net loss for the three-month period ended June 30, 2024 was
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 8:00 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/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.
| OptiNose, Inc. | ||||||||||||||||
| Condensed Consolidated Statement of Operations | ||||||||||||||||
| (in thousands, except share and per share data) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 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 | ||||||||||||
| OptiNose, Inc. | ||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| June 30, | December 31, | |||||||
| 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 June 30, 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 June 30, 2024, which will be filed after the issuance of this press release for additional information. | ||||||||
About Optinose
Optinose is a 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) and expanded market opportunities relating thereto; the potential benefits of XHANCE for the treatment of chronic sinusitis; potential for gradually improving insurance barriers and other enablers of future XHANCE net revenue growth; 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 its current cash and cash equivalents will be sufficient to fund its operations and debt service obligations through 2025; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (including its new indication); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company’s ability to efficiently generate XHANCE prescriptions and net revenues; unanticipated costs and expenses; the Company's ability to achieve its financial guidance; potential for varying interpretation of the results from the ReOpen program; the Company’s ability to comply with the covenants and other terms of its Amended and Restated Note Purchase Agreement; risks and uncertainties relating to intellectual property and competitive products; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company’s most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
FAQ
What was Optinose's (OPTN) XHANCE net revenue for Q2 2024?
Has Optinose (OPTN) updated its XHANCE net revenue guidance for 2024?
What significant formulary access did XHANCE gain in Q2 2024?
How much did Optinose (OPTN) raise in its recent offering?
