Optinose Reports Second Quarter 2018 Financial Results and Recent Operational Highlights
Company reports second quarter net product sales of
Conference call and webcast to be held today at
“We are making progress as a company and continue to believe that XHANCE is an importantly differentiated product that offers significant commercial opportunity,” commented CEO
Second Quarter and Recent Highlights
Commercial Update
Through
As planned,
Based on currently available third party data and our internal analyses, the Company estimates that approximately 76 percent of commercially insured lives are in a plan in which XHANCE is covered in a Tier 3 formulary position.
Publication of Pivotal Efficacy and Long-Term Safety Data for XHANCE
In
NAVIGATE II and EXHANCE-12 were part of a comprehensive development program consisting of five clinical trials evaluating XHANCE in over 1,500 adult patients; including two randomized, double‑blinded, placebo‑controlled Phase 3 pivotal clinical trials in adults with nasal polyposis and two supportive open‑label Phase 3 clinical trials of up to one-year duration in adults with symptoms of chronic sinusitis with or without nasal polyps. Based upon the results of this program, the
XHANCE Development Update
In addition to XHANCE’s existing indication for nasal polyps, we plan to initiate a clinical program to seek a supplemental indication for the treatment of chronic sinusitis in the U.S. in order to broaden our market opportunity. In
Public Offering
In
Second Quarter 2018 Financial Results
Revenue
The Company generated$1.3 million in net revenue through the sales of XHANCE in the three-month period endedJune 30, 2018 . Revenue for the three months endedJune 30, 2018 was primarily generated through the Xperience program.Operating expenses and net loss
For the three-month period endedJune 30, 2018 , research and development expenses were$2.0 million and selling, general and administrative expenses totaled$21.9 million . Net loss for the period was$24.6 million , or$0.64 per share.Cash
The Company had cash and cash equivalents of$245.0 million as ofJune 30, 2018 .
Corporate Guidance
Research and development
The Company expects to initiate a clinical program in pursuit of an additional indication for XHANCE for the "treatment of chronic sinusitis" in the fourth quarter of 2018.Operating Expenses
The Company now believes that total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2018 will be in the range of$117 - $121 million (previous estimate of$119 - $125 million .)
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) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Net product revenues | $ | 1,274 | $ | — | $ | 2,139 | $ | — | ||||||||
Cost of product sales | 351 | — | 551 | — | ||||||||||||
Gross margin | 923 | — | 1,588 | — | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 2,046 | 4,749 | 3,747 | 8,979 | ||||||||||||
Selling, general and administrative | 21,860 | 3,588 | 49,871 | 6,661 | ||||||||||||
Total operating expenses | 23,906 | 8,337 | 53,618 | 15,640 | ||||||||||||
Loss from operations | (22,983 | ) | (8,337 | ) | (52,030 | ) | (15,640 | ) | ||||||||
Other (income) expense: | 1,598 | (129 | ) | 3,124 | 643 | |||||||||||
Net loss | $ | (24,581 | ) | $ | (8,208 | ) | $ | (55,154 | ) | $ | (16,283 | ) | ||||
Deemed dividend | — | 4,083 | — | 7,150 | ||||||||||||
Accretion to redemption value | — | 546 | — | 1,074 | ||||||||||||
Net loss attributable to common stockholders | $ | (24,581 | ) | $ | (12,837 | ) | $ | (55,154 | ) | $ | (24,507 | ) | ||||
Net loss per share of common stock | ||||||||||||||||
basic | $ | (0.64 | ) | $ | (3.16 | ) | $ | (1.44 | ) | $ | (6.02 | ) | ||||
diluted | $ | (0.64 | ) | $ | (3.16 | ) | $ | (1.44 | ) | $ | (6.02 | ) | ||||
Weighted average common shares outstanding | ||||||||||||||||
basic | 38,688,366 | 4,067,717 | 38,271,101 | 4,067,717 | ||||||||||||
diluted | 38,688,366 | 4,067,717 | 38,271,101 | 4,067,717 |
OptiNose, Inc. | ||||||||
Condensed Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
June 30, | December 31, | |||||||
2018 | 2017 | |||||||
(Unaudited) | ||||||||
Cash and cash equivalents | $ | 244,990 | $ | 234,854 | ||||
Other assets | 14,960 | 6,282 | ||||||
Total assets | $ | 259,950 | $ | 241,136 | ||||
Total current liabilities | $ | 23,213 | $ | 14,777 | ||||
Long-term debt, net | 72,138 | 71,863 | ||||||
Other liabilities | 267 | — | ||||||
Total stockholders' equity | 164,332 | 154,496 | ||||||
Total liabilities and stockholders' equity | $ | 259,950 | $ | 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 and timing of a clinical program of XHANCE for chronic sinusitis; projected Company operating expenses for 2018; the potential benefits of XHANCE, the Xperience program and the Company's other patient support 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); the Company's ability to successfully commercialize XHANCE without the support provided by the Xperience program and other patient support programs; market opportunities for XHANCE may be smaller than expected; uncertainties and delays relating to the initiation, enrollment and completion of clinical trials; unanticipated costs; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in our most recent Form 10-K and Form 10-Q filings with the
References
1 - Leopold DA, Elkayam D, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA, NAVIGATE II: randomized, double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis,
doi:10.1016/j.jaci.2018.06.010.
2 - Palmer JN, Jacobsen KW, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. EXHANCE-12: 1-Year Study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018;00:1-8.
Optinose Investor Contact
jonathan.neely@optinose.com
267.521.0531
Optinose Media Contact
ktraynor@sloanepr.com
212.446.1871