YARDLEY, Pa., May 09, 2019 (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 March 31, 2019, and provided recent operational highlights.
“We delivered 59% quarter-over-quarter growth in the number of XHANCE prescriptions during the first quarter of 2019. These strong first quarter results sustain the growth trend we reported in the previous quarter", stated CEO Peter Miller. “Our focus continues to be executing our strategy which includes multiple new growth drivers that we believe will help sustain an excellent rate of growth for XHANCE. These include the internalization of our sales force, completed in April, with a 25% expansion in our sales territories and availability, starting this week, of a new 7-day sample that we believe will encourage trial and adoption of XHANCE.”
First Quarter and Recent Highlights
XHANCE Commercial Update
The number of XHANCE® (fluticasone propionate) prescriptions increased by 59% from fourth quarter 2018 to first quarter 2019.
Based on currently available third-party data and our internal analyses, the Company estimates that more than 75% of commercially insured lives are in a plan in which XHANCE is covered in a Tier 3 formulary position.
In April 2019, the Company expanded its number of sales territories from 80 to 100. The Company plans to call on an estimated 2,200 previously uncalled-on physicians in the new sales territories, and to now target over 10,000 total physicians. At the same time, the Company completed its transition from a contract sales force model to an internal sales force model.
XHANCE Development Update
In addition to XHANCE’s existing indication for nasal polyps, the Company plans to seek approval for a follow-on indication for the treatment of chronic sinusitis in the U.S. in order to broaden its market opportunity. In December 2018, the Company initiated the first of two anticipated Phase 3b clinical trials.
Inexia License Agreement
In January 2019, the Company entered into a license agreement with Inexia Limited (Inexia) whereby Inexia has obtained rights that will enable the use of Optinose’s Exhalation Delivery Systems and other intellectual property in Inexia's effort to discover and develop novel therapies based on positive modulators of Orexin OX1 and OX2 for neurological diseases.
In exchange for this license, the Company received an upfront payment of $0.5 million and, for each product developed under the license agreement, is eligible to receive up to $8.0 million of development milestone payments and up to $37.0 million of sales milestone payments. The Company is also eligible to receive tiered, low-to-mid single digit royalties based on net sales of any products successfully developed and commercialized under the license agreement. Inexia is responsible for all costs and activities related to the identification, development and commercialization of potential products under this license.
First Quarter 2019 Financial Results
Net product and licensing revenues
The Company generated $4.5 million of total revenues including $4.0 million in net product revenues from sales of XHANCE and $0.5 million in licensing revenues during the three-month period ended March 31, 2019.
Costs and expenses and net loss
For the three-month period ended March 31, 2019, research and development expenses were $4.6 million and selling, general and administrative expenses were $26.3 million. The net loss for the period was $28.9 million, or $0.70 per share (basic and diluted).
Cash
The Company had cash and cash equivalents of $171.3 million as of March 31, 2019.
Corporate Guidance
Research and development
The Company expects to initiate a second Phase 3b clinical trial in Q2 2019 to support the pursuit of a new indication for XHANCE for the treatment of chronic sinusitis.
Operating expenses
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2019 to be in the range of $135 - $142 million, of which the Company expects stock-based compensation to be in the range of $10 - $12 million.
About Optinose
Optinose is a global 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.
