Optinose Reports Second Quarter 2021 Financial Results and Recent Operational Highlights
Second quarter 2021 XHANCE net revenue of
Second quarter 2021 XHANCE prescriptions increased 33% from second quarter 2020
Conference call and webcast to be held today at
“We are pleased with the progress we made in second quarter 2021 towards our objectives of growing XHANCE and successfully completing our chronic sinusitis program,” stated CEO
Second Quarter 2021 and Recent Highlights
Total and New XHANCE Prescriptions
The number of total XHANCE® (fluticasone propionate) prescriptions increased by 33% from 62,500 in the second quarter 2020 to 82,900 in the second quarter 2021.
The number of new XHANCE prescriptions increased by 55% from 18,700 in the second quarter of 2020 to 29,000 in the second quarter of 2021.
Enrollment Complete in First Pivotal Chronic Sinusitis Trial
In July, the Company completed patient recruitment in the first of two pivotal clinical trials to evaluate the safety and efficacy of XHANCE as a treatment for patients with chronic sinusitis (CS).
Expert Treatment Algorithm Highlights Role of XHANCE
In June, a new stepped-care treatment algorithm was published in the
The independent algorithm was informed by evidence-based, peer-reviewed data supporting the use of therapeutic and interventional treatments to arrive at the recommended stepwise care paradigm. The publication discusses considerations in a pathway for care that incorporates several new treatments approved in recent years into a logical stepwise escalation of medical care, including but not limited to standard nasal steroid sprays, EDS-FLU (XHANCE), surgery, implants and biologics.
European Inventor Award 2021 for Industry
In June, Dr. Per Djupesland, co-founder and Chief Scientific Officer of Optinose AS, received the European Inventor Award 2021 in the Industry category from the
The European Inventor Award was launched by the EPO in 2006. The finalists and winners are selected by an independent body consisting of international authorities from the fields of business, politics, science, academia and research who examine the proposals for their contribution towards technical progress, social development, economic prosperity and job creation in
Proof-of-concept clinical data is expected to support the Company's pursuit of grants, partnerships, and/or other sources of capital that will be necessary to fund future development.
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenue for the full year of 2021 to be at least
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2021 to be in the range of
Chronic Sinusitis Clinical Trials
The Company has completed enrollment in the first of its two clinical trials evaluating XHANCE as a potential treatment for chronic sinusitis and expects top-line results in the first quarter of 2022. The Company expects to complete patient enrollment in its second clinical trial in the fourth quarter of 2021 and to have top-line results in the second quarter of 2022.
Second Quarter 2021 Financial Results
XHANCE net revenue
The Company generated
Costs and expenses and net loss
For the three and six months ended
The Company had cash and cash equivalents of
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
To participate on the conference call, please dial (866) 916-4761 from the
|Condensed Consolidated Statement of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|Net product revenues||$||18,357||$||10,272||$||29,317||$||17,334|
|Costs and expenses:|
|Cost of product sales||2,425||1,700||4,165||3,056|
|Research and development||8,179||5,474||13,404||10,406|
|Selling, general and administrative||27,308||25,697||54,493||52,757|
|Total costs and expenses||37,912||32,871||72,062||66,219|
|Loss from operations||(19,555||)||(22,599||)||(41,745||)||(48,885||)|
|Net loss per share of common stock, basic and diluted||$||(0.44||)||$||(0.56||)||$||(0.93||)||$||(1.19||)|
|Weighted average common shares outstanding, basic and diluted||53,120,574||45,908,104||53,059,492||45,907,133|
|Condensed Consolidated Balance Sheet Data|
|Cash and cash equivalents||$||93,916||$||144,156|
|Total current liabilities||$||46,798||$||52,172|
|Long-term debt, net||126,043||125,202|
|Total stockholders' equity||(37,073||)||6,788|
|Total liabilities and stockholders' equity||$||139,515||$||188,813|
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
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
Optinose Investor Contact
Source: Optinose, Inc.