Optinose Reports First Quarter 2019 Financial Results and Recent Operational Highlights
Company reports first quarter 2019 total revenues of
XHANCE first quarter net product revenues grew to
XHANCE prescriptions increased 59% from fourth quarter 2018 to first quarter 2019
Conference call and webcast to be held today at
“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
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
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
Inexia License Agreement
In
In exchange for this license, the Company received an upfront payment of
First Quarter 2019 Financial Results
Net product and licensing revenues
The Company generated
Costs and expenses and net loss
For the three-month period ended March 31, 2019, research and development expenses were
Cash
The Company had cash and cash equivalents of
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
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 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
Upcoming Investor Conferences
Chief Executive Officer
A live webcast will be available for each conference in the Investors section of the
OptiNose, Inc. | ||||||||
Condensed Consolidated Statement of Operations | ||||||||
(in thousands, except share and per share data) | ||||||||
(Unaudited) | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2019 | 2018 | |||||||
Revenues: | ||||||||
Net product revenues | $ | 3,976 | $ | 865 | ||||
Licensing revenues | 500 | — | ||||||
Total revenues | 4,476 | 865 | ||||||
Costs and expenses: | ||||||||
Cost of product sales | 738 | 200 | ||||||
Research and development | 4,562 | 1,701 | ||||||
Selling, general and administrative | 26,340 | 28,011 | ||||||
Total costs and expenses | 31,640 | 29,912 | ||||||
Loss from operations | (27,164 | ) | (29,047 | ) | ||||
Other expense | 1,710 | 1,525 | ||||||
Net loss | $ | (28,874 | ) | $ | (30,572 | ) | ||
Net loss per share of common stock, basic and diluted | $ | (0.70 | ) | $ | (0.81 | ) | ||
Weighted average common shares outstanding, basic and diluted | 41,256,050 | 37,849,199 | ||||||
OptiNose, Inc. | ||||||||
Condensed Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
March 31, | December 31, | |||||||
2019 | 2018 | |||||||
(unaudited) | ||||||||
Cash and cash equivalents | $ | 171,316 | $ | 200,990 | ||||
Other assets | 21,676 | 15,999 | ||||||
Total assets | $ | 192,992 | $ | 216,989 | ||||
Total current liabilities | $ | 26,868 | $ | 25,697 | ||||
Long-term debt, net | 72,680 | 72,500 | ||||||
Other liabilities | 1,091 | 181 | ||||||
Total stockholders' equity | 92,353 | 118,611 | ||||||
Total liabilities and stockholders' equity | $ | 192,992 | $ | 216,989 | ||||
About
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 XHANCE growth and potential growth drivers; the Company's plans to call on an estimated 2,200 previously uncalled-on physicians in new sales territories as a result of the sales force expansion; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis, the potential benefits of such indication and the initiation of a second Phase 3b clinical trial in second quarter 2019 in pursuit of such indication; projected Company GAAP operating expenses and stock-based compensation for 2019; the Company's plans to participate in upcoming investor conferences; 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: 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 become profitable; uncertainties and delays relating to the initiation, enrollment, completion, and results of clinical trials; unanticipated costs and expenses; risks and uncertainties relating to drug discovery, development and commercialization and the receipt of payments under the Inexia license agreement; 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
Optinose Investor Contact
jonathan.neely@optinose.com
267.521.0531
Source: Optinose, Inc.