YARDLEY, Pa., Aug. 04, 2020 (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, 2020, and provided operational updates.
“XHANCE prescription volume continued to grow in the second quarter, which was impressive given the major disruptions to patient volumes and care pathways within ENT and allergy physician practices,” stated CEO Peter Miller. “XHANCE had exceptionally strong market share growth, demonstrating remarkable resilience, as we successfully adapted our business to the COVID-19 environment. We are excited by the potential for XHANCE to continue to grow and recently announced a co-promotion with kaléo that will amplify our effort. We look forward to a strong partnership that we believe can have meaningful impact.”
Second Quarter 2020 and Recent Highlights
XHANCE Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions increased by 84% from second quarter 2019 to second quarter 2020.
Kaléo Co-Promotion Agreement
In July the Company announced the signing of an agreement with kaléo, a pharmaceutical company dedicated to building innovative solutions for serious and life-threatening medical conditions, to co-promote XHANCE. Under the terms of the agreement, kaléo will promote XHANCE to an agreed-upon audience of office-based healthcare professionals, which is expected to increase promotional reach and frequency starting by the fourth quarter of 2020. The audience includes nearly 6,000 prescribers about half of whom are outside of the current Optinose called-on universe of approximately 10,000 healthcare professionals.
OPN-019
In June the Company announced the initiation of development of a new product candidate, OPN-019. OPN-019 will combine the Company’s proprietary nasal Exhalation Delivery System (EDS) technology with an antiseptic that has been recently shown in third party in vitro studies to kill the virus that causes COVID-19. Because components of the drug-device combination product candidate, including both the active drug and delivery device, are currently commercially available in the U.S., the Company expects to be able to rapidly progress to a meeting with FDA to discuss an IND and then onward to clinical trials. The Company is focused on supporting the initial stages of development within its current operating expense plan and intends to seek grants, partnerships, and/or other sources of capital to fund future development.
Peer-Reviewed Scientific Journal Publications
Pooled analysis of the Company's NAVIGATE I and II phase 3 clinical trials highlighting improvement in quality of life and health status measures were published in the International Forum of Allergy & Rhinology1.
In addition, results from VIZUALIZE, a study using nasal endoscopy video to evaluate the efficacy and safety of XHANCE twice daily in adults with bilateral nasal polyps were published in Rhinology2, the official journal of the International Rhinologic Society.
Second Quarter 2020 Financial Results
Net product revenues
The Company generated $10.3 million and $17.3 million in net product revenues from sales of XHANCE during the three and six months ended June 30, 2020, respectively.
Costs and expenses and net loss
For the three and six months ended June 30, 2020, research and development expenses were $5.5 million and $10.4 million, respectively and selling, general and administrative expenses were $25.7 million and $52.8 million, respectively. The net loss for the three and six months ended June 30, 2020 was $25.9 million, or $0.56 per share (basic and diluted) and $54.7 million, or $1.19 per share (basic and diluted), respectively.
Cash
The Company had cash and cash equivalents of $125.3 million as of June 30, 2020.
Corporate Guidance
XHANCE Net Revenue per Prescription
The Company expects XHANCE average net revenue per prescription to improve through the remainder of 2020.
Operating Expenses
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2020 to be in the range of $131 - $136 million, of which the Company expects stock-based compensation to be approximately $11 million.
Chronic Sinusitis Clinical Trials
The Company expects top-line results from both of its clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis in the second half of 2021.
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., the U.K. and Norway. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
