Optinose Reports Third Quarter 2018 Financial Results and Recent Operational Highlights
Company reports third quarter net XHANCE revenue of
Company reports 42% monthly XHANCE prescription growth from August to October
Conference call and webcast to be held today at
“We are encouraged by the strong prescription growth driven by our revised commercial efforts, launched in mid-August,” commented CEO
Third Quarter and Recent Highlights
Commercial Update
From August to October monthly XHANCE® prescriptions increased by 42%. Through
Based on currently available third-party data and our internal analyses, the Company estimates that more than 75 percent of commercially insured lives are in a plan in which XHANCE is covered in a Tier 3 formulary position.
Scientific Meeting Presentations
In
Data on XHANCE was highlighted in three podium presentations and one scientific poster presented during the ARS Annual Meeting and in one podium presentation during the AAO-HNSF Annual Meeting.
Abstracts are available on the ARS Annual Meeting and AAO-HNSF Annual Meeting websites.
XHANCE Development Update
In addition to XHANCE’s existing indication for nasal polyps, we plan to initiate a clinical program to seek approval for a follow-on indication for the treatment of chronic sinusitis in the U.S. in order to broaden our market opportunity, and the Company expects to initiate the clinical program in the fourth quarter of 2018.
Third Quarter 2018 Financial Results
Revenue
The Company generated
Operating expenses and net loss
For the three-month period ended
Cash
The Company had cash and cash equivalents of
Corporate Guidance
Research and development
The Company expects to initiate a clinical program in pursuit of a new indication for XHANCE for the treatment of chronic sinusitis in the fourth quarter of 2018.
Operating Expenses
The Company estimates total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2018 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
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 | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| Net product revenues | $ | 1,902 | $ | — | $ | 4,042 | $ | — | |||||||
| Cost of product sales | 319 | — | 870 | — | |||||||||||
| Gross margin | 1,583 | — | 3,172 | — | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 2,989 | 6,641 | 6,736 | 15,620 | |||||||||||
| Selling, general and administrative | 22,086 | 6,553 | 71,957 | 13,214 | |||||||||||
| Total operating expenses | 25,075 | 13,194 | 78,693 | 28,834 | |||||||||||
| Loss from operations | (23,492 | ) | (13,194 | ) | (75,521 | ) | (28,834 | ) | |||||||
| Other (income) expense: | 1,631 | (126 | ) | 4,756 | 517 | ||||||||||
| Net loss | $ | (25,123 | ) | $ | (13,068 | ) | $ | (80,277 | ) | $ | (29,351 | ) | |||
| Deemed dividend | — | 4,105 | — | 11,255 | |||||||||||
| Accretion to redemption value | — | 19 | — | 1,093 | |||||||||||
| Net loss attributable to common stockholders | $ | (25,123 | ) | $ | (17,192 | ) | $ | (80,277 | ) | $ | (41,699 | ) | |||
| Net loss per share of common stock | |||||||||||||||
| basic | $ | (0.61 | ) | $ | (4.23 | ) | $ | (2.04 | ) | $ | (10.25 | ) | |||
| diluted | $ | (0.61 | ) | $ | (4.23 | ) | $ | (2.04 | ) | $ | (10.25 | ) | |||
| Weighted average common shares outstanding | |||||||||||||||
| basic | 41,207,167 | 4,067,717 | 39,260,903 | 4,067,717 | |||||||||||
| diluted | 41,207,167 | 4,067,717 | 39,260,903 | 4,067,717 | |||||||||||
| OptiNose, Inc. | |||||
| Condensed Consolidated Balance Sheet Data | |||||
| (in thousands) | |||||
| September 30, | December 31, | ||||
| 2018 | 2017 | ||||
| (Unaudited) | |||||
| Cash and cash equivalents | $ | 221,491 | $ | 234,854 | |
| Other assets | 16,131 | 6,282 | |||
| Total assets | $ | 237,622 | $ | 241,136 | |
| Total current liabilities | $ | 22,362 | $ | 14,777 | |
| Long-term debt, net | 72,318 | 71,863 | |||
| Other liabilities | 212 | — | |||
| Total stockholders' equity | 142,730 | 154,496 | |||
| Total liabilities and stockholders' equity | $ | 237,622 | $ | 241,136 | |
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 initiation, timing and benefits of a clinical program of XHANCE for chronic sinusitis; projected Company operating expenses for 2018; the potential benefits of the Company's patient affordability programs; 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: the Company’s ability to successfully commercialize XHANCE; physician and patient acceptance of XHANCE; the Company’s ability to obtain adequate third-party reimbursement for XHANCE (market access); market opportunities for XHANCE may be smaller than expected; uncertainties and delays relating to the initiation, enrollment and completion of clinical trials; unanticipated costs; the Company’s ability to grow XHANCE prescriptions and become profitable; 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
