Optinose Reports Third Quarter 2019 Financial Results and Recent Operational Highlights
XHANCE net revenue grew 30% to
XHANCE prescriptions increased 27% from second to third quarter 2019
Company expects XHANCE net revenues for 2019 to be in the range of
Conference call and webcast to be held today at
“XHANCE continues to grow as the result of our successful commercial strategy and we believe there is a significant growth opportunity ahead," stated CEO
Third Quarter 2019 and Recent Highlights
XHANCE Prescription Growth Rates
The number of XHANCE® (fluticasone propionate) prescriptions increased by 27% from second quarter to third quarter 2019 and by 18% from September to
In September, the Company entered into a note purchase agreement for up to
Concurrent with entering into the agreement,
Currax License Agreement
In September, the Company signed an agreement between its
The Company received an
Third Quarter 2019 Financial Results
Revenue
The Company generated
Expenses and net loss
For the three-month and nine-month periods ended September 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 expects 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
Chronic Sinusitis Clinical Trials
The Company expects top line results from the first of its two clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis in the second half of 2021.
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) | |||||||||||||||
Nine Months Ended | Three Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Revenues: | |||||||||||||||
Net product revenues | $ | 19,320 | $ | 4,042 | $ | 8,667 | $ | 1,902 | |||||||
Licensing revenues | 4,230 | — | 3,730 | — | |||||||||||
Total revenues | 23,550 | 4,042 | 12,397 | 1,902 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of product sales | 3,216 | 870 | 1,389 | 319 | |||||||||||
Research and development | 15,404 | 6,736 | 5,547 | 2,989 | |||||||||||
Selling, general and administrative | 77,610 | 71,957 | 25,270 | 22,086 | |||||||||||
Total costs and expenses | 96,230 | 79,563 | 32,206 | 25,394 | |||||||||||
Loss from operations | (72,680 | ) | (75,521 | ) | (19,809 | ) | (23,492 | ) | |||||||
Other expense | 12,378 | 4,755 | 8,999 | 1,631 | |||||||||||
Net loss | $ | (85,058 | ) | $ | (80,276 | ) | $ | (28,808 | ) | $ | (25,123 | ) | |||
Net loss per share of common stock, basic and diluted | $ | (2.06 | ) | $ | (2.04 | ) | $ | (0.69 | ) | $ | (0.61 | ) | |||
Weighted average common shares outstanding, basic and diluted | 41,341,570 | 39,260,903 | 41,454,181 | 41,207,167 |
OptiNose, Inc. | ||||||||
Condensed Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
(unaudited) | ||||||||
Cash and cash equivalents | $ | 125,490 | $ | 200,990 | ||||
Other assets | 23,887 | 15,999 | ||||||
Total assets | $ | 149,377 | $ | 216,989 | ||||
Total current liabilities | $ | 29,962 | $ | 25,697 | ||||
Long-term debt, net | 74,266 | 72,500 | ||||||
Other liabilities | 631 | 181 | ||||||
Total stockholders' equity | 44,518 | 118,611 | ||||||
Total liabilities and stockholders' equity | $ | 149,377 | $ | 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 ability to grow the business to support future profitability; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis and the expectation of top line results from the first of two chronic sinusitis trials in second half 2021; projected XHANCE net revenues for 2019; projected average net 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 and net revenues; uncertainties and delays relating to the enrollment, completion, and results of clinical trials; unanticipated costs and expenses; our ability to comply with the covenants and other terms of the note purchase agreement entered into with funds managed by
Optinose Investor Contact
jonathan.neely@optinose.com
267.521.0531
Source: Optinose, Inc.