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
September 30, 2023, and provided operational updates.
“We are excited as we approach a potentially transformative
period for the company," stated CEO Ramy Mahmoud, MD, MPH. Our
effort to secure the first-ever drug approval for patients with
chronic sinusitis (CS) is progressing towards the FDA’s target goal
date of December 16, 2023. Claims data suggest that CS is currently
being diagnosed by healthcare providers at least 10 times more
frequently than nasal polyps, our current indication for XHANCE. We
are pleased with the progress we made in the third quarter towards
our 2023 operating objectives while sharply reducing expenses.
Today’s results show that we are outperforming our initial
expectations for 2023 XHANCE net revenues while operating far more
efficiently and preparing our organization for a successful launch
in 2024. This progress positions us well, if the new indication is
approved, to achieve rapid adoption of XHANCE for treatment of the
tens of millions of chronic sinusitis patients in need of an
effective medication."
Recent Highlights
Chronic
Rhinosinusitis Supplemental New Drug Application (sNDA)In
May the Company announced that the U.S. Food and Drug
Administration (FDA) accepted its sNDA for XHANCE® (fluticasone
propionate) in the Exhalation Delivery System™ seeking a new
indication for treatment of adults with chronic rhinosinusitis. The
assigned Prescription Drug User Fee Act (PDUFA) goal date is
December 16, 2023.
Third Quarter 2023 Financial
Results
Total
revenuesThe Company reported $19.8 million in net revenue
from sales of XHANCE during the three-month period ended September
30, 2023 a decrease of 1% compared to $20.1 million during the
three-month period ended September 30, 2022. For the nine-month
period ended September 30, 2023 the Company reported $51.1 million
in net revenue from sales of XHANCE a decrease of 8% compared to
$55.4 million during the nine-month period ended September 30,
2022. The year-over-year decrease in net revenue is consistent with
the Company's previously communicated intent to prioritize its
capital resources for a potential launch of XHANCE for the
treatment of chronic sinusitis.
Costs and expenses and net
(loss) incomeFor the three-month and nine-month periods
ended September 30, 2023, research and development expenses were
$1.3 million and $4.0 million, respectively. Selling, general and
administrative expenses were $18.0 million and $60.8 million for
the three-month and nine-month periods ended September 30, 2023,
respectively. In total, SG&A plus R&D expenses decreased by
$31.8 million, or 33%, to $64.9 million for the nine-month period
ended September 30, 2023 when compared to the nine-month period
ended September 30, 2022 total of $96.7 million.
The net loss for the
three-month and nine-month period ended September 30, 2023, was
$9.3 million, or $0.08 per share, and $25.5 million, or $0.23 per
share (basic and diluted), respectively. Net loss for the
three-month and nine-month period ended September 30, 2022 was
$15.0 million, or $0.18 per share, and $59.7 million, or $0.72 per
share (basic and diluted), respectively.
Balance
SheetThe Company had cash and cash equivalents of $66.8
million as of September 30, 2023.
Corporate Guidance
XHANCE Net
Revenue and Average Net Revenue per PrescriptionThe
Company expects XHANCE net revenues for the full year of 2023 to be
between $66.0 to $70.0 million. Previously, the Company expected
XHANCE net revenues for the full year of 2023 to be between $64.0
to $70.0 million. In addition, the Company continues to expect the
full year 2023 XHANCE average net revenue per prescription to be
approximately $200.
Operating
ExpensesThe Company continues to expect total GAAP
operating expenses (selling, general & administrative expenses
and research & development expenses) for 2023 to be in the
range of $88.0 to $93.0 million, of which the Company expects
stock-based compensation to be approximately $6.0 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 8:00 a.m. Eastern Time
today.
Participants may access the conference call live via webcast by
visiting the Investors section of Optinose’s website at
https://ir.optinose.com/presentations. To participate via
telephone, please register in advance at this link. Upon
registration, all telephone participants will receive a
confirmation email detailing how to join the conference call,
including the dial-in number and a personal PIN that can be used to
access the call. 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 |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
19,823 |
|
|
$ |
20,078 |
|
|
$ |
51,122 |
|
|
$ |
55,420 |
|
Total revenues |
|
|
19,823 |
|
|
|
20,078 |
|
|
|
51,122 |
|
|
|
55,420 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of product sales |
|
$ |
2,225 |
|
|
$ |
2,125 |
|
|
|
6,502 |
|
|
|
6,282 |
|
Research and development |
|
$ |
1,281 |
|
|
$ |
3,267 |
|
|
|
4,017 |
|
|
|
12,339 |
|
Selling, general and
administrative |
|
|
18,011 |
|
|
|
25,486 |
|
|
|
60,839 |
|
|
|
84,339 |
|
Total costs and expenses |
|
|
21,517 |
|
|
|
30,878 |
|
|
|
71,358 |
|
|
|
102,960 |
|
Loss from operations |
|
|
(1,694 |
) |
|
|
(10,800 |
) |
|
|
(20,236 |
) |
|
|
(47,540 |
) |
Other (income) expense |
|
|
7,600 |
|
|
|
4,154 |
|
|
|
5,280 |
|
|
|
12,144 |
|
Net loss |
|
$ |
(9,294 |
) |
|
$ |
(14,954 |
) |
|
$ |
(25,516 |
) |
|
$ |
(59,684 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.72 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
112,230,155 |
|
|
|
83,320,704 |
|
|
|
111,996,456 |
|
|
|
82,846,868 |
|
OptiNose, Inc. |
Condensed Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
|
|
|
|
September 30 |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
(unaudited) |
|
|
Cash and cash equivalents |
|
$ |
66,845 |
|
|
$ |
94,244 |
|
Other assets |
|
|
34,562 |
|
|
|
49,978 |
|
Total assets |
|
$ |
101,407 |
|
|
$ |
144,222 |
|
|
|
|
|
|
Total current
liabilities(1) |
|
$ |
163,981 |
|
|
$ |
178,730 |
|
Other liabilities |
|
|
15,041 |
|
|
|
22,116 |
|
Total stockholders'
equity |
|
|
(77,615 |
) |
|
|
(56,624 |
) |
Total liabilities and
stockholders' equity |
|
$ |
101,407 |
|
|
$ |
144,222 |
|
|
|
|
|
|
(1) – All
outstanding principal and fees payable upon maturity have been
classified as a current liability in accordance with Generally
Accepted Accounting Principles ("GAAP") because, as of the date
hereof, the Company believes that it is probable that it will not
maintain compliance with certain financial and liquidity covenants
contained in its Amended and Restated Note Purchase Agreement for
at least the next 12-months. As a result, the Company's unaudited
financial statements for the three and nine months ended September
30, 2023 (“3Q2023 Financial Statements”) will state that there is
substantial doubt about the Company's ability to continue as a
going concern (i.e., a "going concern" paragraph). Please refer to
the Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023 (including the 3Q2023 Financial Statements)
which will be filed after the issuance of this press release for
additional information. |
About OptinoseOptinose is a
specialty pharmaceutical company focused on serving the needs of
patients cared for by ear, nose and throat (ENT) and allergy
specialists. To learn more, please visit www.optinose.com or follow
us on X and LinkedIn.
About XHANCEXHANCE is a
drug-device combination product that uses the Exhalation Delivery
System (also referred to as the EDS) designed to deliver a topical
anti-inflammatory to the high and deep regions of the nasal cavity
where sinuses ventilate and drain. XHANCE is approved by the U.S.
Food and Drug Administration for the treatment of chronic
rhinosinusitis with nasal polyps in patients 18 years of age or
older and has been studied for treatment of chronic sinusitis
(notably including patients without polyps in the nasal cavity) in
two phase 3 trials, ReOpen1 and ReOpen2. The results from these
trials are the first ever that we are aware of that show
improvement in both symptoms and inflammation inside the sinuses,
and reduction in acute exacerbations of disease, with a nasal
therapy for chronic sinusitis patients, including patients with or
without nasal polyps. If approved, XHANCE may be the first drug
ever FDA-approved for treatment of chronic rhinosinusitis either
with or without nasal polyps.
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any
ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local Nasal Adverse Reactions:
epistaxis, erosion, ulceration, septal perforation, Candida
albicans infection, and impaired wound healing. Monitor patients
periodically for signs of possible changes on the nasal mucosa.
Avoid use in patients with recent nasal ulcerations, nasal surgery,
or nasal trauma until healing has occurred.
- Close monitoring for glaucoma and
cataracts is warranted.
- Hypersensitivity reactions (e.g.,
anaphylaxis, angioedema, urticaria, contact dermatitis, rash,
hypotension, and bronchospasm) have been reported after
administration of fluticasone propionate. Discontinue XHANCE if
such reactions occur.
- Immunosuppression and Risk of
Infection: potential increased susceptibility to or worsening of
infections (e.g., existing tuberculosis; fungal, bacterial, viral,
or parasitic infection; ocular herpes simplex). Use with caution in
patients with these infections. More serious or even fatal course
of chickenpox or measles can occur in susceptible patients.
- Hypercorticism and adrenal
suppression may occur with very high dosages or at the regular
dosage in susceptible individuals. If such changes occur,
discontinue XHANCE slowly.
- Patients with major risk factors
for decreased bone mineral content should be monitored and treated
with established standards of care.
ADVERSE REACTIONS: The most common adverse
reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration,
nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations,
nasal congestion, acute sinusitis, nasal septal erythema, headache,
and pharyngitis.
DRUG INTERACTIONS: Strong cytochrome P450 3A4
inhibitors (e.g., ritonavir, ketoconazole): Use not recommended.
May increase risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS: Hepatic
impairment. Monitor patients for signs of increased drug
exposure.
Please see full Prescribing Information, including Instructions
for Use
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
benefits of XHANCE for the treatment of chronic sinusitis without
nasal polyps (also referred to as, chronic sinusitis or chronic
rhinosinusitis); the potential for XHANCE to be the first
FDA-approved drug treatment for chronic sinusitis and the potential
benefits thereof; objectives and preparations to launch XHANCE, if
approved, for the treatment of chronic sinusitis; potential for an
FDA action on the sNDA in December 2023; projected XHANCE net
revenue and average net revenue per prescription for full year
2023; projected Company GAAP operating expenses (selling, general
and administrative expenses and research & development
expenses) and stock-based compensation for 2023; potential
non-compliance with certain covenants under the Amended and
Restated Pharmakon Note Purchase Agreement and the consequences
thereof; and other statements regarding the Company's future
operations, financial performance, financial position, prospects,
objectives, strategies 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 for its current and any potential
future indication; the Company’s ability to maintain adequate
third-party reimbursement for XHANCE (market access) including any
future indication; the prevalence of chronic sinusitis and market
opportunities for XHANCE may be smaller than expected; the
Company’s ability to efficiently generate XHANCE prescriptions and
net revenues; unanticipated costs and expenses; the Company's
ability to achieve its financial guidance; potential for varying
interpretation of the results from the ReOpen program;
uncertainties related to the clinical development program and
regulatory approval of XHANCE for the treatment of chronic
rhinosinusitis; the potential that the FDA does not meet the PDUFA
target goal date; the Company’s ability to comply with the
covenants and other terms of the Amended and Restated Pharmakon
Note Purchase Agreement; the Company's ability to continue as a
going concern; 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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