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 ended
March 31, 2021, and provided operational updates.
“XHANCE net revenues increased 55% in the first quarter of 2021
compared to first quarter 2020,” stated CEO Peter Miller. “We
believe this is strong growth, particularly in the context of the
continuing impact of the COVID-19 pandemic on the number of
patients visiting physician offices and pandemic-related
restrictions that continue to limit in-person detailing of
physician offices by our territory managers. Improvement to the
business environment is just one factor that we believe will
support XHANCE growth in the remainder of 2021. XHANCE growth and
the completion of our clinical trials evaluating it for treatment
of chronic sinusitis are the two most important objectives for our
company right now and we are focused on achieving those as a
team.”
First Quarter 2021 and Recent
Highlights
Total and New XHANCE
Prescriptions
The number of XHANCE® (fluticasone propionate) prescriptions
increased by 30% from 56,100 in the first quarter 2020 to 72,600 in
the first quarter 2021.
The number of new prescriptions for XHANCE increased by 16% from
22,300 in the first quarter of 2020 to 25,900 in the first quarter
of 2021.
First Quarter 2021 Financial
Results
Total revenuesThe Company
generated $11.0 million in net product revenues from sales of
XHANCE during the three-month period ended March 31, 2021. In
addition, the Company generated $1.0 million of licensing revenue
during the three-month period ended March 31, 2021. Total revenue
for the three-month period ended March 31, 2021 was $12.0
million.
Costs and expenses and net lossFor the
three-month period ended March 31, 2021, research and development
expenses were $5.2 million and selling, general and administrative
expenses were $27.2 million. The net loss for the period was $26.1
million, or $0.49 per share (basic and diluted).
CashThe Company had cash and
cash equivalents of $116.0 million as of March 31, 2021.
Corporate Guidance
XHANCE Net Revenue and Average Net
Revenue per PrescriptionThe Company expects XHANCE net
revenues for the full year of 2021 to be at least $80 million. In
addition, the Company expects full year 2021 XHANCE net revenue per
prescription to increase compared to full year 2020 XHANCE net
revenue per prescription of $185.
Operating ExpensesThe Company expects total
GAAP operating expenses (selling, general & administrative
expenses and research & development expenses) for 2021 to be in
the range of $137 - $142 million, of which the Company expects
stock-based compensation to be approximately $10 million.
Chronic Sinusitis Clinical TrialsThe Company
now expects to complete enrollment in the first of its clinical
trials evaluating XHANCE as a potential treatment for Chronic
Sinusitis in third quarter 2021 with top line results in first
quarter 2022. The Company expects top line results from the other
trial in the first half of 2022.
OPN-019In March 2021, the
Company announced its plan to conduct 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 will evaluate both the magnitude and duration of
viral load reduction after a single dose of OPN-019. Regulatory
approval to initiate the pilot study is pending. The Company
expects top-line results from this study in second quarter
2021.
The Company is focused on supporting the initial stages of
OPN-019 development within its current operating expense guidance
and intends to seek grants, partnerships, and/or other sources of
capital to fund future development.
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 May 12, 2021 by dialing (855)
859-2056 from the U.S. or +1 (404) 537-3406 from outside the U.S.
and entering conference ID #5283136. 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 |
| |
March 31, |
| |
2021 |
|
2020 |
| Revenues: |
|
|
|
|
Net product revenues |
$ |
10,960 |
|
|
$ |
7,062 |
|
| Licensing revenues |
$ |
1,000 |
|
|
— |
|
|
Total revenues |
11,960 |
|
|
7,062 |
|
| Costs and expenses: |
|
|
|
|
Cost of product sales |
1,740 |
|
|
1,356 |
|
|
Research and development |
5,225 |
|
|
4,932 |
|
|
Selling, general and administrative |
27,184 |
|
|
27,060 |
|
|
Total costs and expenses |
34,149 |
|
|
33,348 |
|
|
Loss from operations |
(22,189 |
) |
|
(26,286 |
) |
| Other expense |
3,864 |
|
|
2,570 |
|
| Net loss |
$ |
(26,053 |
) |
|
$ |
(28,856 |
) |
| Net loss per share of common
stock, basic and diluted |
$ |
(0.49 |
) |
|
$ |
(0.63 |
) |
| Weighted average common shares
outstanding, basic and diluted |
52,997,730 |
|
|
45,906,162 |
|
|
OptiNose, Inc. |
|
Condensed Consolidated Balance Sheet Data |
|
(in thousands) |
| |
|
|
|
| |
March 31, |
|
December 31, |
| |
2021 |
|
2020 |
| |
(unaudited) |
|
|
|
Cash and cash equivalents |
$ |
115,984 |
|
|
$ |
144,156 |
|
| Other assets |
41,962 |
|
|
44,657 |
|
| Total assets |
$ |
157,946 |
|
|
$ |
188,813 |
|
| |
|
|
|
| Total current liabilities |
$ |
44,781 |
|
|
$ |
52,172 |
|
| Long-term debt, net |
125,584 |
|
|
125,202 |
|
| Other liabilities |
4,248 |
|
|
4,651 |
|
| Total stockholders'
equity |
(16,667 |
) |
|
6,788 |
|
| Total liabilities and
stockholders' equity |
$ |
157,946 |
|
|
$ |
188,813 |
|
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; 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; the
expectation of completing enrollment in the first of its chronic
sinusitis trials in the third quarter of 2021 with top-line results
in the first quarter of 2022 and top line results from the second
trial in the first half of 2022; projected average net revenue per
prescription for full year 2021; projected XHANCE net revenue for
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; the Company's ability to satisfy
the conditions for an additional draw under the Pharmakon note
purchase agreement and its ability to comply with the covenants and
other terms of the agreement; 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
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