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
June 30, 2023, and provided operational updates.
“We are pleased with the progress we made in the
second quarter of 2023 towards our strategic objectives,” stated
CEO Ramy Mahmoud, MD, MPH. “That means we are outperforming our
initial expectations for full year 2023 XHANCE net revenues while
operating far more efficiently. It also means our effort to secure
the first-ever drug approval for patients with chronic sinusitis is
progressing towards the target goal date of December 16, 2023, and
that we are effectively readying our organization for a successful
launch. These objectives are preparing us, if our new indication is
approved, to achieve rapid adoption for treatment of the tens of
millions of chronic sinusitis patients in need of an effective
medication.”
Second Quarter 2023
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)
target goal date is December 16, 2023.
Additional U.S. Patent Covering
XHANCEThe United States Patent and Trademark Office
(USPTO) recently issued an additional patent covering XHANCE. U.S.
Patent 11,602,603, was listed in the FDA’s Approved Drug Products
with Therapeutic Equivalence Evaluations (Orange Book) for XHANCE
in April and has a term that expires in 2028. XHANCE is covered by
15 Orange Book-listed patents.
The full text of the patent is available on the USPTO website
www.uspto.gov.
Second Quarter 2023 Financial
Results
Total revenuesThe Company
reported $19.5 million in net revenue from sales of XHANCE during
the three-month period ended June 30, 2023 a decrease of 5%
compared to $20.6 million during the three-month period ended June
30, 2022. For the six-month period ended June 30, 2023 the Company
reported $31.3 million in net revenue from sales of XHANCE a
decrease of 11% compared to $35.3 million during the six-month
period ended June 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 rhinosinusitis.
Costs and expenses and net (loss) income
For the three-month and six-month periods ended
June 30, 2023, research and development expenses were $1.0 million
and $2.7 million, respectively. Selling, general and administrative
expenses were $20.1 million and $42.8 million for the three-month
and six-month periods ended June 30, 2023, respectively. In total,
SG&A plus R&D expenses decreased by $22.4 million, or 33%,
to $45.6 million for the six-month period ended June 30, 2023 when
compared to the six-month period ended June 30, 2022, total of
$67.9 million.
Other income of $6.8 million for the three-month
period ended June 30, 2023, includes a $10.9 million unrealized
gain on the fair value of warrants issued in November 2022.
Net income for the three-month period ended June
30, 2023, was $2.6 million, or $0.02 per share (basic and diluted).
The net loss for the six-month period ended June 30, 2023, was
$16.2 million, or $0.15 per share (basic and diluted).
Balance SheetThe Company had
cash and cash equivalents of $71.3 million as of June 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 $64.0 to $70.0
million. Previously, the Company expected XHANCE net revenues for
the full year of 2023 to be between $62.0 to $68.0 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 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 |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
19,454 |
|
|
$ |
20,582 |
|
|
$ |
31,299 |
|
|
$ |
35,342 |
|
Total revenues |
|
|
19,454 |
|
|
|
20,582 |
|
|
|
31,299 |
|
|
|
36,342 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of product sales |
|
$ |
2,571 |
|
|
$ |
2,143 |
|
|
|
4,277 |
|
|
|
4,157 |
|
Research and development |
|
$ |
951 |
|
|
$ |
4,270 |
|
|
|
2,736 |
|
|
|
9,072 |
|
Selling, general and
administrative |
|
|
20,104 |
|
|
|
29,514 |
|
|
|
42,828 |
|
|
|
58,853 |
|
Total costs and expenses |
|
|
23,626 |
|
|
|
35,927 |
|
|
|
49,841 |
|
|
|
72,082 |
|
Loss from operations |
|
|
(4,172 |
) |
|
|
(15,345 |
) |
|
|
(18,542 |
) |
|
|
(35,740 |
) |
Other (income) expense |
|
|
(6,798 |
) |
|
|
4,052 |
|
|
|
(2,318 |
) |
|
|
7,990 |
|
Net income (loss) |
|
$ |
2,626 |
|
|
$ |
(19,397 |
) |
|
$ |
(16,224 |
) |
|
$ |
(43,730 |
) |
|
|
|
|
|
|
|
|
|
Less: undistributed earnings
to participating shareholders |
|
$ |
(53 |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Net (loss) income - basic |
|
$ |
2,573 |
|
|
$ |
(19,397 |
) |
|
$ |
(16,224 |
) |
|
$ |
(43,730 |
) |
Net income (loss) per share of
common stock - basic |
|
$ |
0.02 |
|
|
$ |
(0.23 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.54 |
) |
Weighted average common shares
outstanding - basic |
|
|
111,979,778 |
|
|
|
82,740,096 |
|
|
|
111,877,669 |
|
|
|
82,594,786 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
2,626 |
|
|
$ |
(19,397 |
) |
|
$ |
(16,224 |
) |
|
$ |
(43,730 |
) |
Less: undistributed earnings
to participating shareholders |
|
$ |
(53 |
) |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
Net (loss) income -
diluted |
|
$ |
2,573 |
|
|
$ |
(19,397 |
) |
|
$ |
(16,224 |
) |
|
$ |
(43,730 |
) |
Net income (loss) per share of
common stock - diluted |
|
$ |
0.02 |
|
|
$ |
(0.23 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.54 |
) |
Weighted average common shares
outstanding - diluted |
|
|
112,042,097 |
|
|
|
82,740,096 |
|
|
|
111,877,669 |
|
|
|
82,594,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OptiNose, Inc. |
Condensed Consolidated Balance Sheet Data |
(in thousands) |
|
|
|
|
|
|
|
June 30 |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
(unaudited) |
|
|
Cash and cash equivalents |
|
$ |
71,311 |
|
|
$ |
94,244 |
|
Other assets |
|
|
34,757 |
|
|
|
49,978 |
|
Total assets |
|
$ |
106,068 |
|
|
$ |
144,222 |
|
|
|
|
|
|
Total current liabilities
(1) |
|
$ |
164,299 |
|
|
$ |
178,730 |
|
Other liabilities |
|
|
11,429 |
|
|
|
22,116 |
|
Total stockholders’
equity |
|
|
(69,660 |
) |
|
|
(56,624 |
) |
Total liabilities and
stockholders’ equity |
|
$ |
106,068 |
|
|
$ |
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 six months ended June 30,
2023 (“Q22023 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
June 30, 2023 (including the 2Q2023 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 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 without nasal polyps (commonly referred to as,
chronic sinusitis); 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; patent
protections; 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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