Optinose Reports Third Quarter 2022 Financial Results and Operational Updates
Company plans to submit an sNDA for XHANCE as a treatment for chronic sinusitis in early 2023
Physicians Diagnose Chronic Sinusitis 10 Times More Frequently Than XHANCE’s Current Nasal Polyps Indication and there is no FDA-Approved Medication for these Patients
Company reports third quarter 2022 XHANCE net revenue of
Company expects full year 2022 XHANCE net revenue to be between
Company expects full year 2022 operating expenses to be between
Conference call and webcast to be held today at
“We are pleased with the progress we made in third quarter of 2022 on our supplemental New Drug Application for XHANCE," stated CEO
Third Quarter 2022 and Recent Highlights
Chronic Sinusitis Supplemental New Drug Application (sNDA)
In September the Company met with the
The Company now anticipates submission of the sNDA in early 2023. Previously the Company planned for a submission by the end of 2022. The Company believes the additional time has enabled it to incorporate feedback from the September meeting with FDA into its sNDA submission.
Scientific Meeting Presentations
Data from the landmark ReOpen program evaluating the efficacy and safety of XHANCE in adult patients with chronic sinusitis was presented at the
ARS Top-Rated Abstracts - Clinical Rhinology Presentation: Re-Open-1: A randomized double-blind placebo-controlled trial of EDS-FLU for CRSwNP or CRSsNP.
IDWeek Late Breaking Presentation: Exhalation Delivery System with Fluticasone (EDS-FLU) Significantly Reduces Acute Exacerbations and Associated Antibiotic Use in Chronic Rhinosinusitis.
In addition, data from the ReOpen program is expected to be presented at the
Third Quarter 2022 Financial Results
The Company reported
Costs and expenses and net loss
For the three-month period ended
The Company had cash and cash equivalents of
In accordance with FASB Accounting Standards, the Company has classified all outstanding principal and fees under its debt as a current liability in the accompanying condensed consolidated balance sheet as of
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2022 to be between
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2022 to be in the range of
Previously the Company expected total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2022 to be in the range of
In addition, the Company expects total GAAP operating expenses for full year 2023 to decrease materially compared to full year 2022 total GAAP operating expenses.
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/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.
|Condensed Consolidated Statement of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|Net product revenues||$||20,078||$||21,826||$||55,420||$||51,143|
|Costs and expenses:|
|Cost of product sales||2,125||2,411||6,282||6,576|
|Research and development||3,267||6,654||12,339||20,058|
|Selling, general and administrative||25,486||25,801||84,339||80,293|
|Total costs and expenses||30,878||34,866||102,960||106,927|
|Loss from operations||(10,800||)||(13,040||)||(47,540||)||(54,784||)|
|Net loss per share of common stock, basic and diluted||$||(0.18||)||$||(0.32||)||$||(0.72||)||$||(1.25||)|
|Weighted average common shares outstanding, basic and diluted||83,320,704||53,334,669||82,846,868||53,151,730|
|Condensed Consolidated Balance Sheet Data|
|Cash and cash equivalents||$||61,080||$||110,502|
|Total current liabilities||$||177,795||$||59,235|
|Long-term debt, net||—||126,418|
|Total stockholders' equity||(73,416||)||(21,772||)|
|Total liabilities and stockholders' equity||$||105,270||$||166,071|
About Chronic Sinusitis
Chronic sinusitis (CS), cited as the second most common chronic disease of adults in the US, is a serious chronic inflammatory disease affecting as many as 30 million adults in
XHANCE® is a drug-device combination product that uses the Exhalation Delivery System® (also referred to as the EDS®) designed to deliver a topical anti-inflammatory to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. 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.
- Close monitoring for glaucoma and cataracts is warranted.
- 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: 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.
- Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.
ADVERSE REACTIONS: 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.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the
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: impact of, and uncertainties caused by the COVID-19 pandemic; physician and patient acceptance of XHANCE for its current and any potential future indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (market access); the prevalence of chronic sinusitis; market opportunities for XHANCE may be smaller than expected; the Company’s ability to grow XHANCE prescriptions and net revenues; unanticipated costs and expenses; potential for varying interpretation of results from ReOpen1 and ReOpen2; uncertainties related to the clinical development program and regulatory approval of XHANCE for the treatment of chronic sinusitis; the Company’s ability to comply with the covenants and other terms of the note purchase agreement entered into with funds managed by
Optinose Investor Contact
Source: Optinose, Inc.