• Optinose Reports Third Quarter 2021 Financial Results and Recent Operational Highlights

    Source: Nasdaq GlobeNewswire / 15 Nov 2021 16:26:45   America/New_York

    Third quarter 2021 XHANCE net revenue of $22 million increased 41% compared to third quarter 2020

    Third quarter 2021 XHANCE prescriptions increased 25% from third quarter 2020

    Conference call and webcast to be held tomorrow at 8:30 a.m. Eastern Time

    YARDLEY, Pa., Nov. 15, 2021 (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, 2021, and provided operational updates.

    “We continued to make progress during third quarter 2021 towards our objectives of growing XHANCE and successfully completing our chronic sinusitis program,” stated CEO Peter Miller. “XHANCE net revenue increased 41% compared to third quarter 2020 and we completed enrollment in the second of our two pivotal chronic sinusitis clinical trials. I am pleased with the business that we have built promoting XHANCE as a treatment for the approximately 1 million patients diagnosed with nasal polyps. But what excites me is the significant new opportunities for growth if we are successful in developing XHANCE as a treatment for chronic sinusitis. A label expansion for chronic sinusitis will expand the target patient population for which our specialty-focused sales force can promote XHANCE as an appropriate treatment from approximately 1 million patients to approximately 3 million patients diagnosed and treated by the physicians that we target today. In addition, there is potential for a partner to leverage their deployed presence in primary care to expand promotion of XHANCE to a total of up to 30 million people in the U.S. who have chronic sinusitis.”

    Third Quarter 2021 and Recent Highlights

    Total and New XHANCE Prescriptions
    The number of total XHANCE® (fluticasone propionate) prescriptions increased by 25% from 69,000 in the third quarter of 2020 to 86,300 in the third quarter of 2021.   

    The number of new XHANCE prescriptions increased by 22% from 23,000 in the third quarter of 2020 to 27,900 in the third quarter of 2021.

    Enrollment Complete in Second Pivotal Chronic Sinusitis Trial
    In October, the Company completed patient recruitment in the second of two pivotal clinical trials to evaluate the safety and efficacy of XHANCE as a treatment for patients with chronic sinusitis (CS). Enrollment in the first pivotal trial was completed in July 2021.

    OPN-019
    In October 2021, the Company completed enrollment of the first cohort of approximately 10 patients in a randomized, proof-of-concept study being conducted in Mexico. Up to three cohorts of 10 patients are planned.
    This pilot study will evaluate both the magnitude and duration of viral load reduction after a single dose of OPN-019 in subjects who tested positive for SARS-CoV-2 infection. Further recruitment in this trial is currently paused while specimen-handling and laboratory procedures in Mexico undergo further evaluation.

    Corporate Guidance

    XHANCE Net Revenue and Average Net Revenue per Prescription
    The Company expects XHANCE net revenue for the full year of 2021 to be in the range of $71 - $75 million. Previously the company expected XHANCE net revenue for the full year of 2021 to be at least $80 million.

    In addition, the Company expects full year 2021 XHANCE net revenue per prescription to be greater than $210. Previously the company expected full year 2021 XHANCE net revenue per prescription to be greater than $200.

    Operating Expenses
    The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2021 to be in the range of $132 - $137 million, of which the Company expects stock-based compensation to be approximately $10 million.

    Previously the Company expected total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2021 to be in the range of $137 - $142 million, of which the Company expected stock-based compensation to be approximately $10 million.

    Chronic Sinusitis Clinical Trials
    The Company has completed enrollment in both of its clinical trials evaluating XHANCE as a potential treatment for chronic sinusitis and expects top-line results from the first trial, ReOpen1, in the first quarter of 2022 and from the second trial, ReOpen2, in the second quarter of 2022.

    Third Quarter 2021 Financial Results

    XHANCE Net Revenue
    The Company generated $21.8 million and $51.1 million in net revenue from sales of XHANCE during the three and nine months ended September 30, 2021, respectively. Net revenue from sales of XHANCE increased 41% and 56% during the three and nine months ended September 30, 2021 compared to the three and nine months ended September 30, 2020, respectively.

    Costs and Expenses and Net Loss
    For the three and nine months ended September 30, 2021, research and development expenses were $6.7 million and $20.1 million, respectively and selling, general and administrative expenses were $25.8 million and $80.3 million, respectively. The net loss for the three and nine months ended September 30, 2021 was $(17.1) million, or $0.32 per share (basic and diluted) and $66.7 million, or $1.25 per share (basic and diluted), respectively.

    Cash
    The Company had cash and cash equivalents of $84.2 million as of September 30, 2021.

    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 on Tuesday, November 16, 2021, beginning at 8:30 a.m. Eastern Time .

    To participate on the conference call, please dial (866) 916-4761 from the U.S. or +1 (409) 216-6496 from outside the U.S. In addition, following the completion of the call, a telephone replay will be accessible until Tuesday, November 23, 2021 by dialing (855) 859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S. and entering conference ID # 9477523. A simultaneous webcast of the call and presentation can be accessed by visiting the Investors section of Optinose’s website at www.optinose.com. 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,
     2021 2020 2021 2020
    Revenues:       
    Net product revenues$21,826   $15,436   $51,143   $32,770  
    Licensing revenues—   $—   $1,000   —  
    Total revenues21,826   $15,436   52,143   32,770  
    Costs and expenses:       
    Cost of product sales2,411   2,221   6,576   5,276  
    Research and development6,654   6,524   20,058   16,930  
    Selling, general and administrative25,801   24,575   80,293   77,332  
    Total costs and expenses34,866   33,320   106,927   99,538  
    Loss from operations(13,040)  (17,884)  (54,784)  (66,768) 
    Other expense4,077   3,330   11,888   9,154  
    Net loss$(17,117)  $(21,214)  $(66,672)  $(75,922) 
    Net loss per share of common stock, basic and diluted$(0.32)  $(0.43)  $(1.25)  $(1.62) 
    Weighted average common shares outstanding, basic and diluted53,334,669   48,907,514   53,151,730   46,914,561  


    OptiNose, Inc.
    Condensed Consolidated Balance Sheet Data
    (in thousands)
        
     September 30, December 31,
     2021 2020
     (unaudited)  
    Cash and cash equivalents$84,226   $144,156 
    Other assets47,691   44,657 
    Total assets$131,917   $188,813 
        
    Total current liabilities$53,627   $52,172 
    Long-term debt, net126,542   125,202 
    Other liabilities3,217   4,651 
    Total stockholders' equity(51,469)  6,788 
    Total liabilities and stockholders' equity$131,917   $188,813 

    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. Optinose has offices in the U.S. and Norway. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.

    About XHANCE
    XHANCE is a drug-device combination product that uses an Optinose Exhalation Delivery System (EDS™) device designed to deliver a topical anti-inflammatory corticosteroid to high and deep regions of the nasal cavity. XHANCE was approved for the treatment of nasal polyps in patients 18 years of age or older by the U.S. Food and Drug Administration in September 2017 and is currently being studied for treatment of chronic sinusitis. If successful, XHANCE may be the first FDA-approved drug product for chronic sinusitis.

    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 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 for continued or increased XHANCE prescription and net revenue growth and potential growth drivers; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis and the potential benefits of such indication; the expectation of top-line results from its first chronic sinusitis trial in the first quarter of 2022 and top line results from the second trial in the second quarter of 2022; projected average net revenue per prescription for full year 2021; projected XHANCE net revenue for full year 2021; projected Company GAAP operating expenses and stock-based compensation for 2021; development, funding plans for OPN-019 and the potential benefits of OPN-019; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives 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: impact of, and uncertainties caused by the COVID-19 pandemic; physician and patient acceptance of XHANCE; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (market access); market opportunities for XHANCE may be smaller than expected; the Company’s ability to grow XHANCE prescriptions and net revenues; uncertainties and delays relating to the enrollment, completion, and results of clinical trials; unanticipated costs and expenses; the Company's ability to comply with the covenants and other terms of the Pharmakon note purchase agreement; the Company's ability to continue as a going concern; risks and uncertainties relating to intellectual property; 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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