Optinose Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Operational Highlights
Optinose reported Q4 2020 net revenue of $15.6 million and full-year revenue of $48.4 million from XHANCE. This reflects a 70% increase in prescriptions year-over-year. The company forecasts XHANCE revenue to exceed $80 million in 2021. Clinical trial results for XHANCE as a treatment for Chronic Sinusitis are expected by year-end 2021. Despite a net loss of $23.9 million in Q4 2020, the cash balance was $144.2 million. Optinose anticipates first quarter revenue declines but expects stronger performance later in 2021.
- XHANCE prescriptions increased by 70% year-over-year.
- Q4 2020 net revenue was $15.6 million, up from $11.1 million in Q4 2019.
- Company expects XHANCE net revenue to exceed $80 million in 2021.
- Net loss of $23.9 million in Q4 2020.
- Projected revenue decline for Q1 2021 compared to Q4 2020 due to average net revenue per prescription.
- Total operating expenses expected to be between $137 million and $142 million in 2021.
Company reports fourth quarter and full year 2020 XHANCE net revenue of
Full year 2020 XHANCE prescriptions increased
Company expects XHANCE net revenue for 2021 to be at least
Company expects top-line results from one of its clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis by the end of 2021
Conference call and webcast to be held today at 8:00 a.m. Eastern Time
YARDLEY, Pa., March 03, 2021 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter and year ended December 31, 2020, and provided recent operational highlights.
"I am proud of how the team at Optinose responded to the market disruptions created by the global pandemic, enabling us to deliver
Fourth Quarter 2020 and Recent Highlights
Total and New XHANCE Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions increased by
The number of new prescriptions for XHANCE increased by
OPN-019
In June 2020, the Company announced the initiation of development of a new product candidate, OPN-019, which combines its proprietary intranasal Exhalation Delivery System (EDS) with an antiseptic.
Because components of the drug-device combination product candidate, including both the active drug and delivery device, are currently commercially available in the U.S., the Company anticipates a potential streamlined and accelerated development. Subsequent to a pre-Investigational New Drug (IND) submission the Company is engaged with FDA regarding an IND and clinical development pathway.
The Company has performed in vitro testing against SARS-CoV-2 with a candidate formulation in which a 4-log reduction (a
In April 2021, the Company expects to initiate a randomized, proof of concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. This pilot study being conducted in Mexico will evaluate both the magnitude and duration of viral load reduction after a single dose of OPN-019. The Company expects top-line results from this study in second quarter 2021.
The Company is focused on supporting the initial stages of development within our current operating expense guidance and intend to seek grants, partnerships, and/or other sources of capital to fund future development.
Fourth Quarter 2020 Financial Results
Revenue
The Company generated
Expenses and net loss
For the three-month and twelve-month periods ended December 31, 2020, research and development expenses were
Cash
The Company had cash and cash equivalents of
Corporate Guidance
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2020 to be at least
Operating Expenses
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2021 to be in the range of
Chronic Sinusitis Clinical Trials
The Company expects top-line results from one of its clinical trials evaluating XHANCE as a potential treatment for Chronic Sinusitis by the end of 2021 and the other in the first half of 2022. Pauses in patient enrollment, due to the COVID-19 pandemic, at some clinical trial sites changed the Company's prior expectation of top-line results from both trials 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 8:00 a.m. Eastern Time today.
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 March 10, 2021 by dialing (855) 859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S. and entering conference ID: 9833299.
A simultaneous webcast of the call and presentation can be accessed by visiting the Investors section of Optinose’s website at www.optinose.com. In addition, a replay of the webcast will be available on the Company website for 60 days following the event.
| OptiNose, Inc. | |||||||||||||||
| Condensed Consolidated Statement of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Three Months Ended | Year Ended | ||||||||||||||
| December 31, | December 31, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||||
| Revenues: | |||||||||||||||
| Net product revenues | $ | 15,597 | $ | 11,081 | $ | 48,367 | $ | 30,401 | |||||||
| Licensing revenues | 750 | — | 750 | 4,230 | |||||||||||
| Total revenues | 16,347 | 11,081 | 49,117 | 34,631 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Cost of product sales | 2,244 | 2,078 | 7,520 | 5,294 | |||||||||||
| Research and development | 6,448 | 5,379 | 23,378 | 20,783 | |||||||||||
| Selling, general and administrative | 28,107 | 26,545 | 105,438 | 104,155 | |||||||||||
| Total costs and expenses | 36,799 | 34,002 | 136,336 | 130,232 | |||||||||||
| Loss from operations | (20,452 | ) | (22,921 | ) | (87,219 | ) | (95,601 | ) | |||||||
| Other expense | 3,412 | 2,075 | 12,567 | 14,452 | |||||||||||
| Net loss | $ | (23,864 | ) | $ | (24,996 | ) | $ | (99,786 | ) | $ | (110,053 | ) | |||
| Net loss per share of common stock, basic and diluted | $ | (0.46 | ) | $ | (0.58 | ) | $ | (2.07 | ) | $ | (2.63 | ) | |||
| Weighted average common shares outstanding, basic and diluted | 52,327,655 | 43,467,985 | 48,275,230 | 41,877,527 | |||||||||||
| OptiNose, Inc. | ||||||||
| Condensed Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| Cash and cash equivalents | $ | 144,156 | $ | 147,144 | ||||
| Other assets | 44,657 | 25,506 | ||||||
| Total assets | $ | 188,813 | $ | 172,650 | ||||
| Total current liabilities | 52,172 | $ | 36,139 | |||||
| Long-term debt, net | 125,202 | 74,531 | ||||||
| Other liabilities | 4,651 | 397 | ||||||
| Total stockholders' equity | 6,788 | 61,583 | ||||||
| Total liabilities and stockholders' equity | $ | 188,813 | $ | 172,650 | ||||
About Optinose
Optinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. Optinose has offices in the U.S. and Norway. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
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 or increased XHANCE prescription and net revenue growth and potential growth drivers; early year effects on price and volume related to patient insurance; 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 one of its chronic sinusitis trials by the end of 2021 and the other in the first half of 2022; projected average net revenue per prescription for first quarter and full year 2021; projected XHANCE net revenue for first quarter and full year 2021; projected Company GAAP operating expenses and stock-based compensation for 2021; development, timing of data, and funding plans for OPN-019 and the potential benefits of OPN-019; 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: impact of, and uncertainties caused by the COVID-19 pandemic; 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 Pharmakon Advisors, LP; 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 Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor Contact
Jonathan Neely
jonathan.neely@optinose.com
267.521.0531
FAQ
What were Optinose's Q4 2020 financial results?
How did XHANCE perform in 2020?
What is the revenue forecast for Optinose in 2021?
When will Optinose provide updates on its clinical trials?
