Optinose Reports Second Quarter 2019 Financial Results and Recent Operational Highlights
XHANCE net revenue grew 68% to
XHANCE prescriptions increased 51% from first to second quarter 2019
Company expects XHANCE net revenues for 2019 to be in the range of
Conference call and webcast to be held today at
“We delivered 51% quarter-over-quarter growth in the number of XHANCE prescriptions during the second quarter of 2019, making this the third consecutive quarter of 50% or greater prescription growth," stated CEO
Second Quarter 2019 and Recent Highlights
XHANCE Commercial Update
The number of XHANCE® (fluticasone propionate) prescriptions increased by 51% from first quarter to second quarter 2019 and by 17% from June to
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
XHANCE Development Update
In addition to XHANCE’s existing indication for treatment of nasal polyps, the Company plans to seek approval for a follow-on indication for treatment of chronic sinusitis in the U.S. in order to broaden its market opportunity. In
Additional U.S. Patents Covering XHANCE
The United States Patent and Trademark Office (USPTO) recently issued two patents covering XHANCE. These patents, U.S. Patents 10,252,010 and 10,300,229, have been listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for XHANCE and have terms that expire in years 2031 and 2035, respectively. XHANCE is now covered by 15 Orange Book-listed patents.
Second Quarter 2019 Financial Results
Revenue
The Company generated
Expenses and net loss
For the three-month period ended June 30, 2019, research and development expenses were
Cash
The Company had cash and cash equivalents of
Corporate Guidance
XHANCE Net Revenue
The Company expects XHANCE net revenue for 2019 to be in the range of
XHANCE Average Net Revenue per Prescription
The Company continues to expect XHANCE average net revenue per prescription for 2019, which is calculated by dividing XHANCE net revenue for 2019 by the estimated number of XHANCE prescriptions dispensed during 2019, to be in the range of
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
OptiNose, Inc. | |||||||||||||||
Condensed Consolidated Statement of Operations | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
(Unaudited) | |||||||||||||||
Six Months Ended | Three Months Ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Revenues: | |||||||||||||||
Net product revenues | $ | 10,653 | $ | 2,139 | $ | 6,677 | $ | 1,274 | |||||||
Licensing revenues | 500 | — | — | — | |||||||||||
Total revenues | 11,153 | 2,139 | 6,677 | 1,274 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of product sales | 1,827 | 551 | 1,089 | 351 | |||||||||||
Research and development | 9,857 | 3,747 | 5,295 | 2,046 | |||||||||||
Selling, general and administrative | 52,340 | 49,871 | 26,000 | 21,860 | |||||||||||
Total costs and expenses | 64,024 | 54,169 | 32,384 | 24,257 | |||||||||||
Loss from operations | (52,871 | ) | (52,030 | ) | (25,707 | ) | (22,983 | ) | |||||||
Other expense | 3,380 | 3,124 | 1,670 | 1,598 | |||||||||||
Net loss | $ | (56,251 | ) | $ | (55,154 | ) | $ | (27,377 | ) | $ | (24,581 | ) | |||
Net loss per share of common stock, basic and diluted | $ | (1.36 | ) | $ | (1.44 | ) | $ | (0.66 | ) | $ | (0.64 | ) | |||
Weighted average common shares outstanding, basic and diluted | 41,283,478 | 38,271,101 | 41,310,608 | 38,688,366 |
OptiNose, Inc. | ||||||||
Condensed Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
June 30, | December 31, | |||||||
2019 | 2018 | |||||||
(unaudited) | ||||||||
Cash and cash equivalents | $ | 143,963 | $ | 200,990 | ||||
Other assets | 22,609 | 15,999 | ||||||
Total assets | $ | 166,572 | $ | 216,989 | ||||
Total current liabilities | $ | 24,367 | $ | 25,697 | ||||
Long-term debt, net | 72,869 | 72,500 | ||||||
Other liabilities | 864 | 181 | ||||||
Total stockholders' equity | 68,472 | 118,611 | ||||||
Total liabilities and stockholders' equity | $ | 166,572 | $ | 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, potential growth drivers and market opportunity; 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; projected XHANCE net revenues for 2019; projected average revenue per prescription for 2019; projected Company GAAP operating expenses and stock-based compensation for 2019; 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; uncertainties and delays relating to the enrollment, completion, and results of clinical trials; unanticipated costs and expenses; 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
Optinose Investor Contact
jonathan.neely@optinose.com
267.521.0531
Source: Optinose, Inc.