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, 2023, and provided operational updates.
“We are pleased with the progress we made in the first quarter
of 2023 towards our strategic objectives," stated CEO Ramy Mahmoud,
MD, MPH. "Our effort to secure the first-ever drug approval for
patients with chronic sinusitis took a major step forward last week
when we announced that our supplemental new drug application was
accepted for review with a target goal date of December 16, 2023.
We are preparing our organization for a successful launch and
operating more efficiently in our current business. These
objectives are aimed at rapidly achieving uptake in the millions of
chronic sinusitis patients in need of an effective therapy."
First Quarter 2023 and 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) Exhalation Delivery System™ seeking a new indication
for treatment of adults with chronic rhinosinusitis. The assigned
Prescription Drug User Fee Act (PDUFA) target goal date is December
16, 2023.
Additional U.S. Patents
Covering XHANCEThe United States Patent and Trademark
Office (USPTO) recently issued two additional patents covering
XHANCE. These patents, U.S. Patents 11,554,229 and 11,602,603, have
been listed in the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations (Orange Book) for XHANCE and have terms
that expire in years 2036 and 2028, respectively. XHANCE is now
covered by 15 Orange Book-listed patents.
The full text of each patent is
available on the USPTO website www.uspto.gov.
First Quarter 2023 Financial
Results
Total
revenuesThe Company reported $11.8 million in net revenue
from sales of XHANCE during the three-month period ended March 31,
2023, a decrease of 20% compared to $14.8 million during the
three-month period ended March 31, 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
rhinosinusitis and its guidance for first quarter 2023 net revenues
to be approximately $10.0 million.
Costs and expenses and net
lossFor the three-month period ended March 31, 2023,
research and development expenses were $1.8 million and selling,
general and administrative expenses were $22.7 million. The net
loss for the period was $18.8 million, or $0.17 per share (basic
and diluted).
Balance
SheetThe Company had cash and cash equivalents of $83.9
million as of March 31, 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 $62.0 to $68.0 million. In addition, the Company expects
the full year 2023 XHANCE average net revenue per prescription to
be approximately $200.
Operating
ExpensesThe Company expects 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.
Previously the Company expected total
GAAP operating expenses (selling, general & administrative
expenses and research & development expenses) for 2023 to be in
the range of $90.0 to $95.0 million, of which the Company expected
stock-based compensation to be approximately $8.0 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
http://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 |
|
March 31, |
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
Net product revenues |
|
11,846 |
|
|
|
14,760 |
|
Total revenues |
|
11,846 |
|
|
|
14,760 |
|
Costs and expenses: |
|
|
|
Cost of product sales |
|
1,706 |
|
|
|
2,014 |
|
Research and development |
|
1,785 |
|
|
|
4,802 |
|
Selling, general and administrative |
|
22,723 |
|
|
|
29,339 |
|
Total costs and expenses |
|
26,214 |
|
|
|
36,155 |
|
Loss from operations |
|
(14,368 |
) |
|
|
(21,395 |
) |
Other expense |
|
4,479 |
|
|
|
3,938 |
|
Net loss |
$ |
(18,847 |
) |
|
$ |
(25,333 |
) |
Net loss per share of common
stock, basic and diluted |
$ |
(0.17 |
) |
|
$ |
(0.31 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
111,774,425 |
|
|
|
82,447,861 |
|
|
|
|
|
|
|
|
|
OptiNose, Inc. |
Condensed Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
|
|
March 31 |
|
December 31, |
|
|
2023 |
|
|
|
2022 |
|
|
(unaudited) |
|
|
Cash and cash equivalents |
$ |
83,928 |
|
|
$ |
94,244 |
|
Other assets |
|
30,997 |
|
|
|
49,978 |
|
Total assets |
$ |
114,925 |
|
|
$ |
144,222 |
|
|
|
|
|
Total current liabilities
(1) |
$ |
166,303 |
|
|
$ |
178,729 |
|
Other liabilities |
|
22,407 |
|
|
|
22,116 |
|
Total stockholders'
equity |
|
(73,785 |
) |
|
|
(56,623 |
) |
Total liabilities and
stockholders' equity |
$ |
114,925 |
|
|
$ |
144,222 |
|
|
|
|
|
(1) – All
outstanding principal and fees payable upon maturity have been
classified as a current liability in accordance with Generally
Accepted Accounting Principals ("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 months ended March 31, 2023
(“Q12023 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 year ended
March 31, 2023 (including the Q12023 Financial Statements) which
will be filed after the issuance of this press release for
additional information. |
|
About OptinoseOptinose is a
global 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 Twitter 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. Top-line 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; the
potential for XHANCE to be the first FDA-approved drug treatment
for chronic sinusitis and the potential benefits thereof; patent
protections; projected XHANCE net revenue and average net revenue
per prescription for full year 2023; projected Company GAAP
(selling, general and administrative expenses and research &
development expenses) operating 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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