Optinose Reports Third Quarter 2024 Financial Results and Recent Operational Highlights
Optinose (NASDAQ:OPTN) reported Q3 2024 financial results with XHANCE net revenue of $20.4 million, up 3% from Q3 2023. The company observed a positive inflection in new prescriptions starting September, with October showing a 20-40% increase in weekly new prescriptions. However, the company decreased its full-year 2024 XHANCE net revenue guidance to $75.0-79.0 million from previous $85.0-90.0 million. Operating expenses guidance was reduced to $90.0-93.0 million. The company reported Q3 net income of $0.5 million, while maintaining cash and cash equivalents of $82.5 million as of September 30, 2024.
Optinose (NASDAQ:OPTN) ha riportato i risultati finanziari del terzo trimestre 2024 con un fatturato netto di XHANCE di 20,4 milioni di dollari, in aumento del 3% rispetto al terzo trimestre 2023. L'azienda ha osservato un'inflessione positiva nelle nuove prescrizioni a partire da settembre, con ottobre che ha mostrato un aumento del 20-40% nelle nuove prescrizioni settimanali. Tuttavia, l'azienda ha ridotto la sua previsione di fatturato netto per XHANCE per l'intero anno 2024 a 75,0-79,0 milioni di dollari, rispetto ai precedenti 85,0-90,0 milioni di dollari. Anche la guida per le spese operative è stata ridotta a 90,0-93,0 milioni di dollari. L'azienda ha riportato un reddito netto di 0,5 milioni di dollari nel terzo trimestre, mantenendo contante e equivalenti in contante di 82,5 milioni di dollari al 30 settembre 2024.
Optinose (NASDAQ:OPTN) reportó los resultados financieros del tercer trimestre de 2024 con ingresos netos de XHANCE de 20.4 millones de dólares, un aumento del 3% en comparación con el tercer trimestre de 2023. La compañía observó una inflexión positiva en las nuevas recetas a partir de septiembre, con octubre mostrando un aumento del 20-40% en las nuevas recetas semanales. Sin embargo, la compañía redujo su guía de ingresos netos para XHANCE para todo el año 2024 a 75.0-79.0 millones de dólares, desde anteriormente 85.0-90.0 millones de dólares. La guía para los gastos operativos se redujo a 90.0-93.0 millones de dólares. La compañía reportó un ingreso neto de 0.5 millones de dólares en el tercer trimestre, manteniendo efectivo y equivalentes de efectivo de 82.5 millones de dólares al 30 de septiembre de 2024.
옵티노스 (NASDAQ:OPTN)는 2024년 3분기 재무 결과를 보고하며, XHANCE의 순수익이 2040만 달러로, 2023년 3분기 대비 3% 증가했다고 전했습니다. 회사는 9월부터 새로운 처방전에 긍정적인 전환점을 목격했으며, 10월에는 매주 새로운 처방전이 20-40% 증가했다고 합니다. 그러나, 회사는 2024년 전체 연도 XHANCE 순수익 전망을 이전 8500-9000만 달러에서 7500-7900만 달러로 하향 조정했습니다. 운영비 안내도 9000-9300만 달러로 줄였습니다. 회사는 2024년 9월 30일 기준으로 50만 달러의 순이익을 보고했으며, 현금 및 현금성 자산은 8천250만 달러를 유지하고 있습니다.
Optinose (NASDAQ:OPTN) a annoncé ses résultats financiers pour le troisième trimestre 2024 avec un revenu net de XHANCE de 20,4 millions de dollars, en hausse de 3 % par rapport au troisième trimestre 2023. L'entreprise a observé une inflexion positive des nouvelles prescriptions à partir de septembre, avec octobre montrant une augmentation de 20 à 40 % des nouvelles prescriptions hebdomadaires. Cependant, l'entreprise a abaissé ses prévisions de revenus nets pour XHANCE pour l'année 2024 à 75,0-79,0 millions de dollars, contre 85,0-90,0 millions de dollars auparavant. Les prévisions de dépenses d'exploitation ont également été réduites à 90,0-93,0 millions de dollars. L'entreprise a déclaré un revenu net de 0,5 million de dollars au troisième trimestre, tout en maintenant des liquidités et équivalents de liquidités de 82,5 millions de dollars au 30 septembre 2024.
Optinose (NASDAQ:OPTN) berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 mit XHANCE Nettoerlösen von 20,4 Millionen US-Dollar, was einem Anstieg von 3% im Vergleich zum 3. Quartal 2023 entspricht. Das Unternehmen beobachtete einen positiven Anstieg neuer Rezepte ab September, wobei Oktober einen Anstieg von 20-40% bei den wöchentlichen Neuschreibungen zeigte. Das Unternehmen hat jedoch seine Prognose für die Nettoerlöse von XHANCE für das gesamte Jahr 2024 auf 75,0-79,0 Millionen US-Dollar von zuvor 85,0-90,0 Millionen US-Dollar gesenkt. Auch die Prognose für die Betriebsausgaben wurde auf 90,0-93,0 Millionen US-Dollar reduziert. Das Unternehmen meldete für das 3. Quartal einen Nettogewinn von 0,5 Millionen US-Dollar und verfügte zum 30. September 2024 über liquide Mittel und Baräquivalente in Höhe von 82,5 Millionen US-Dollar.
- Q3 2024 XHANCE net revenue increased 3% year-over-year to $20.4 million
- New prescriptions showed 20-40% growth in October 2024
- Q3 2024 resulted in net income of $0.5 million
- Strong cash position with $82.5 million in cash and cash equivalents
- Reduced full-year 2024 XHANCE revenue guidance from $85-90M to $75-79M
- Nine-month net loss of $21.2 million
- Company faces potential non-compliance with financial covenants
- Substantial doubt about company's ability to continue as going concern
Insights
The Q3 results and revised guidance present significant concerns. Revenue growth of only
The going concern warning is particularly troubling, indicating potential covenant compliance issues with their debt agreement. Despite having
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 8:00 a.m. Eastern Time
YARDLEY, Pa., Nov. 12, 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 September 30, 2024, and provided recent operational highlights.
“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 June 28, 2024 through September 6, 2024. With the inflection first observed in September, the moving average increased to approximately 2,300 to 2,500 NRx per week in October (through the week ended October 25) an increase of approximately
Third Quarter 2024 Financial Results
Total revenues
The Company reported
Costs and expenses and net loss
For the three-month and nine-month periods ended September 30, 2024, research and development expenses were
The net income for the three-month period ended September 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 be approximately
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/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 | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 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 | ||||||||||||
| OptiNose, Inc. | ||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| September 30, | December 31, | |||||||
| 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 September 30, 2024 (“3Q2024 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (including the 3Q2024 Financial Statements) 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, 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 the Exhalation Delivery System; the Company’s expectations 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; key drivers that generate promotional response for XHANCE; the Company's believe that the inflection in new prescription demand which started in September reinforces the magnitude of the longer-term opportunity for XHANCE; the Company's belief that its experience in the initial phases of the launch has improved its understanding of the key drivers of adoption and that this experience will help support achievement of its peak year objective for XHANCE; the Company's belief 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 and the consequences thereof; 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; the risk that the positive inflection in new XHANCE prescriptions starting in September does not continue and grow; the Company’s ability to comply with the covenants and other terms of its Amended and Restated Note Purchase Agreement; the Company’s ability to continue as a going concern; 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
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