Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or
“the Company”, “we”, or “our”), a commercial-stage pharmaceutical
company that primarily focuses on selling and marketing U.S. Food
and Drug Administration (“FDA”) approved prescription
pharmaceutical products for the treatment of dermatological
conditions, today announced financial results and recent corporate
highlights for the first quarter ended March 31, 2025.
“The first quarter of 2025 was highly
productive, as our in-line dermatology products continue to perform
and the launch of Emrosi™, our best-in-class oral rosacea
treatment, is off to a strong start,” said Claude Maraoui, Journey
Medical’s Co-Founder, President and Chief Executive Officer. “The
Emrosi launch is enjoying high visibility among dermatology
prescribers with momentum from our exhibition booth at the American
Academy of Dermatology (AAD) conference in late March, the recent
publication of Emrosi’s statistically superior Phase 3 clinical
trial results over Oracea® and placebo in JAMA Dermatology, and the
promotional efforts from our experienced and highly effective
dermatology salesforce. Emrosi was also recently incorporated into
the National Rosacea Society’s Rosacea Treatment Algorithms, and
payer coverage of the product continues to increase.”
Mr. Maraoui continued, “Financially, we remain
in a strong position with $21.1 million in cash as of March 31, an
improvement in our gross margin, and overall operating spend down
year-over-year. We believe that our first quarter financial results
and launch progress with Emrosi demonstrate that we are executing
on our strategic objectives, and that 2025 will be a
transformational year for the Company as we drive the business to
sustainable positive EBITDA and profitability.”
Financial Results:
- Total net product revenues of $13.1
million for the first quarter of 2025 were consistent with $13.0
million of net product revenues for the first quarter of 2024. The
first quarter of 2025 includes $2.1 million of incremental net
product revenue related to the U.S. commercial launch of
Emrosi.
- The Company’s gross margin(1)
increased to 64% for the first quarter of 2025, from 54% in the
prior period due to lower overall product cost of goods related to
product sales mix and non-recurring charges in the prior year.
- Research and development costs were
nil in the first quarter of 2025, compared to $7.9 million in the
first quarter of 2024. The first quarter of 2024 includes Emrosi
pre-approval project expenses, milestones and fees.
- Selling, general and administrative
expenses increased by $2.1 million for the three-month period ended
March 31, 2025, from $8.4 million for the three-month period ended
March 31, 2024. The increase is primarily due to the incremental
operational activities related to the launch and commercialization
of Emrosi.
- The Company’s net loss was $4.1
million, or $(0.18) per share basic and diluted, for the first
quarter of 2025, compared to a net loss of $10.4 million, or
$(0.53) per share basic and diluted, for the first quarter of
2024.
- At March 31, 2025, the Company had
$21.1 million in cash and cash equivalents as compared to $20.3
million in cash and cash equivalents at December 31, 2024.
Recent Corporate
Highlights:
- In April 2025, Journey Medical
appointed Ramsey Alloush as its Chief Operating Officer. Mr.
Alloush joined the Company as General Counsel in 2020.
- At the end of March 2025, Journey
Medical announced initial distribution to pharmacies and first
prescriptions filled. Full commercial launch began on April 7,
2025.
- In March 2025, the Journal of the
American Medical Association - Dermatology published the Phase 3
clinical trial results of Emrosi for the treatment of rosacea,
highlighting that Emrosi achieved the co-primary and all secondary
endpoints in two Phase 3 trials and demonstrated statistical
superiority against both Oracea(2) and placebo with no significant
safety issues when administered once daily for 16 weeks.
- In March 2025, the National Rosacea
Society published its updated Rosacea Treatment Algorithms to
include low-dose oral minocycline (referenced in the brand index as
Emrosi™). The Updated Treatment Algorithms can be accessed at
https://www.rosacea.org/physicians/rosacea-treatment-algorithms.
Information on such website is not a part of this release.
- In February 2025, Journey Medical
hosted a conference call and webcast to discuss its U.S. commercial
launch plan for Emrosi (40 mg Minocycline Hydrochloride
Modified-Release Capsules) for the treatment of rosacea. A replay
of the webcast is available on the IR calendar page of the Journey
Medical website, and can be accessed at
https://ir.journeymedicalcorp.com/new-events/ir-calendar.
Information on such website is not a part of this release.
Conference Call and Webcast
InformationJourney Medical management will conduct a
conference call and audio webcast on May 14, 2025, at 4:30 p.m.
ET.
To listen to the conference call, interested
parties within the U.S. should dial 1-866-777-2509 (domestic) or
1-412-317-5413 (international). All callers should dial in
approximately 10 minutes prior to the scheduled start time and ask
to be joined into the Journey Medical conference call. Participants
can register for the conference here:
https://dpregister.com/sreg/10199519/ff117b0a70. Please note that
registered participants will receive their dial-in number upon
registration.
A live audio webcast can be accessed on the News
and Events page of the Investors section of Journey Medical’s
website, www.journeymedicalcorp.com, and will remain available for
replay for approximately 30 days after the meeting.
(1) We define gross margin as net product
revenue less cost of goods sold divided by net product revenue.(2)
Oracea® is a registered trademark of Galderma Holdings, S.A.
Société Anonyme.
About Journey Medical
CorporationJourney Medical Corporation (Nasdaq: DERM)
(“Journey Medical”) is a commercial-stage pharmaceutical company
that primarily focuses on the selling and marketing of FDA-approved
prescription pharmaceutical products for the treatment of
dermatological conditions through its efficient sales and marketing
model. The Company currently markets eight branded FDA-approved
prescription drugs that help treat and heal common skin conditions.
The Journey Medical team comprises industry experts with extensive
experience in developing and commercializing some of dermatology’s
most successful prescription brands. Journey Medical is located in
Scottsdale, Arizona and was founded by Fortress Biotech, Inc.
(Nasdaq: FBIO). Journey Medical’s common stock is registered under
the Securities Exchange Act of 1934, as amended, and it files
periodic reports with the U.S. Securities and Exchange Commission
(“SEC”). For additional information about Journey Medical, visit
www.journeymedicalcorp.com.
Forward-Looking StatementsThis
press release may contain “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
As used below and throughout this press release, the words “the
Company”, “we”, “us” and “our” may refer to Journey Medical. Such
statements include, but are not limited to, any statements relating
to our growth strategy and product development programs and any
other statements that are not historical facts. The words
“anticipate,” “believe,” “estimate,” “may,” “expect,” “will,”
“could,” “project,” “intend,” “potential” and similar expressions
are generally intended to identify forward-looking statements.
Forward-looking statements are based on management’s current
expectations and are subject to risks and uncertainties that could
negatively affect our business, operating results, financial
condition and stock price. Factors that could cause actual results
to differ materially from those currently anticipated include: the
fact that our products and product candidates are subject to time
and cost intensive regulation and clinical testing and as a result,
may never be successfully developed or commercialized; a
substantial portion of our sales derive from products that may
become subject to third-party generic competition, the introduction
of new competitor products, or an increase in market share of
existing competitor products, any of which could have a significant
adverse impact on our operating income; we operate in a heavily
regulated industry, and we cannot predict the impact that any
future legislation or administrative or executive action may have
on our operations; our revenue is dependent mainly upon sales of
our dermatology products and any setback relating to the sale of
such products could impair our operating results; competition could
limit our products’ commercial opportunity and profitability,
including competition from manufacturers of generic versions of our
products; the risk that our products do not achieve broad market
acceptance, including by government and third-party payors; our
reliance third parties for several aspects of our operations; our
dependence on our ability to identify, develop, and acquire or
in-license products and integrate them into our operations, at
which we may be unsuccessful; the dependence of the success of our
business, including our ability to finance our company and generate
additional revenue, on the successful commercialization of our
recently approved product, Emrosi™, and any future product
candidates that we may develop, in-license or acquire; clinical
drug development is very expensive, time consuming, and uncertain
and our clinical trials may fail to adequately demonstrate the
safety and efficacy of our current or any future product
candidates; our competitors could develop and commercialize
products similar or identical to ours; risks related to the
protection of our intellectual property and our potential inability
to maintain sufficient patent protection for our technology and
products; our business and operations would suffer in the event of
computer system failures, cyber-attacks, or deficiencies in our or
our third parties’ cybersecurity; the substantial doubt about our
ability to continue as a going concern; the effects of major public
health issues, epidemics or pandemics on our product revenues and
any future clinical trials; our potential need to raise additional
capital; Fortress controls a voting majority of our common stock,
which could be detrimental to our other shareholders; as well as
other risks described in Part I, Item 1A, “Risk Factors,” in our
Annual Report on Form 10-K for the year ended December 31, 2024,
subsequent Reports on Form 10-Q, and our other filings we make with
the SEC. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations or any changes in events, conditions or circumstances
on which any such statement is based, except as may be required by
law, and we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995.
Company Contact:Jaclyn Jaffe (781)
652-4500ir@jmcderm.com
Media Relations Contact:Tony Plohoros6
Degrees(908) 591-2839tplohoros@6degreespr.com
JOURNEY
MEDICAL CORPORATION |
Unaudited
Condensed Consolidated Balance Sheets |
(Dollars in
thousands except for share and per share amounts) |
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
2025 |
|
|
2024 |
|
ASSETS |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
21,070 |
|
|
$ |
20,305 |
|
Accounts receivable, net of reserves |
18,025 |
|
|
10,231 |
|
Inventory |
12,496 |
|
|
14,431 |
|
Prepaid expenses and other current assets |
2,395 |
|
|
3,212 |
|
Total
current assets |
53,986 |
|
|
48,179 |
|
|
|
|
|
|
|
Intangible assets, net |
30,798 |
|
|
31,863 |
|
Operating lease right-of-use asset, net |
178 |
|
|
199 |
|
Total assets |
$ |
84,962 |
|
|
$ |
80,241 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
$ |
14,404 |
|
|
$ |
16,050 |
|
Due to related party |
399 |
|
|
528 |
|
Accrued expenses |
23,011 |
|
|
17,425 |
|
Accrued interest |
381 |
|
|
404 |
|
Income taxes payable |
59 |
|
|
60 |
|
Term loan - short-term |
1,875 |
|
|
- |
|
Installment payments – licenses, short-term |
- |
|
|
625 |
|
Operating lease liability, short-term |
93 |
|
|
83 |
|
Total
current liabilities |
40,222 |
|
|
35,175 |
|
|
|
|
|
|
|
Term loan -
long-term, net of discount |
23,105 |
|
|
24,879 |
|
Operating
lease liability, long-term |
94 |
|
|
118 |
|
Total liabilities |
63,421 |
|
|
60,172 |
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
Common stock, $.0001 par value, 50,000,000 shares authorized,
17,104,437 and 16,153,610 shares issued and outstanding as of March
31, 2025 and December 31, 2024, respectively |
1 |
|
|
1 |
|
Common stock - Class A, $.0001 par value, 50,000,000 shares
authorized, 6,000,000 shares issued and outstanding as of March 31,
2025 and December 31, 2024 |
1 |
|
|
1 |
|
Additional paid-in capital |
112,639 |
|
|
107,094 |
|
Accumulated deficit |
(91,100 |
) |
|
(87,027 |
) |
Total stockholders' equity |
21,541 |
|
|
20,069 |
|
Total liabilities and stockholders' equity |
$ |
84,962 |
|
|
$ |
80,241 |
|
|
|
|
|
|
|
|
|
JOURNEY
MEDICAL CORPORATION |
Unaudited
Condensed Consolidated Statements of Operations |
(Dollars in
thousands except for share and per share amounts) |
|
|
|
|
|
|
|
|
Three-Month
Periods Ended |
|
|
March 31, |
|
|
2025 |
|
|
|
2024 |
|
Revenue: |
|
|
|
|
|
Product revenue, net |
$ |
13,139 |
|
|
$ |
13,030 |
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
Cost of goods sold – (excluding amortization of acquired intangible
assets) |
|
4,790 |
|
|
|
6,002 |
|
Amortization of acquired intangible assets |
|
1,065 |
|
|
|
814 |
|
Research and development |
|
39 |
|
|
|
7,884 |
|
Selling, general and administrative |
|
10,569 |
|
|
|
8,420 |
|
Total
operating expenses |
|
16,463 |
|
|
|
23,120 |
|
Loss from
operations |
|
(3,324 |
) |
|
|
(10,090 |
) |
|
|
|
|
|
|
Other expense (income) |
|
|
|
|
|
Interest income |
|
(149 |
) |
|
|
(217 |
) |
Interest expense |
|
891 |
|
|
|
548 |
|
Foreign exchange transaction losses |
|
7 |
|
|
|
21 |
|
Total other
expense (income) |
|
749 |
|
|
|
352 |
|
Loss
before income taxes |
|
(4,073 |
) |
|
|
(10,442 |
) |
|
|
|
|
|
|
Income tax
expense |
|
- |
|
|
|
- |
|
Net
loss |
$ |
(4,073 |
) |
|
$ |
(10,442 |
) |
|
|
|
|
|
|
Net loss per
common share: |
|
|
|
|
|
Basic
and diluted |
$ |
(0.18 |
) |
|
$ |
(0.53 |
) |
Weighted
average number of common shares: |
|
|
|
|
|
Basic
and diluted |
|
22,611,040 |
|
|
|
19,757,449 |
|
|
|
|
|
|
|
|
|
Use of Non-GAAP Measures:
In addition to the GAAP financial measures as
presented in our Form 10-Q that will be filed with the Securities
and Exchange Commission (“SEC”), the Company has, in this press
release, included certain non-GAAP measurements, including Adjusted
EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per
share diluted. We define Adjusted EBITDA as net income (loss)
excluding interest, taxes and depreciation, less certain other
non-cash and infrequent items not considered to be normal,
recurring operating expenses, including, share-based compensation
expense, amortization and impairments of acquired intangible
assets, inventory step-ups from the purchases of intangibles assets
and products, severance, short-term research and development
expense and foreign exchange transaction losses. In particular, we
exclude the following matters for the reasons more fully described
below:
- Share-Based Compensation Expense: We exclude share-based
compensation from our adjusted financial results because
share-based compensation expense, which is non-cash, fluctuates
from period to period based on factors that are not within our
control, such as our stock price on the dates share-based grants
are issued.
- Non-core and Short-term Research and Development Expense:
We exclude research and development costs incurred principally in
connection with Emrosi, which was the only product in our portfolio
not currently approved for marketing and sale during the prior-year
reporting period, because we do not consider such costs to be
normal, recurring operating expenses that are core to our long-term
strategy. Instead, our long-term strategy is focused on the
marketing and sale of our core FDA-approved dermatological products
and the out licensing our intellectual property and related
technologies.
- Amortization and impairments of Acquired Intangible
assets: We exclude the impact of certain amounts recorded in
connection with the acquisitions of intangible assets that are
either non-cash or not normal, recurring operating expenses due to
their nature, variability of amounts, and lack of predictability as
to occurrence and/or timing. These amounts may include non-cash
items such as the amortization impairments of acquired intangible
assets and amortization of step-ups of acquisition accounting
adjustments to inventories.
Adjusted EBITDA per share basic and Adjusted
EBITDA per share diluted are determined by dividing the resulting
Adjusted EBITDA by the number of shares outstanding on an actual
and fully diluted basis.
Management believes the use of these non-GAAP
measures provide meaningful supplemental information regarding the
Company’s performance because (i) it allows for greater
transparency with respect to key measures used by management in its
financial and operational decision-making, (ii) it excludes the
impact of non-cash or, when specified, non-recurring items that are
not directly attributable to the Company’s core operating
performance and that may obscure trends in the Company’s core
operating performance and (iii) it is used by institutional
investors and the analyst community to help analyze the Company's
results. However, Adjusted EBITDA, Adjusted EBITDA per share basic,
Adjusted EBITDA per share diluted and any other non-GAAP financial
measures should be considered as a supplement to, and not as a
substitute for, or superior to, the corresponding measures
calculated in accordance with GAAP. Further, non-GAAP financial
measures used by the Company and the manner in which they are
calculated may differ from the non-GAAP financial measures or the
calculations of the same non-GAAP financial measures used by other
companies, including the Company’s competitors.
The table below provides a reconciliation from
GAAP to non-GAAP measures:
JOURNEY
MEDICAL CORPORATIONReconciliation of GAAP to
Non-GAAP Adjusted EBITDA ($ in thousands except for share
and per share amounts) |
|
|
|
|
|
Three-Month
Periods Ended |
|
|
March
31, |
|
|
|
2025 |
|
|
|
2024 |
|
GAAP
Net Loss |
|
$ |
(4,073 |
) |
|
$ |
(10,442 |
) |
|
|
|
|
|
EBITDA: |
|
|
|
|
Interest |
|
|
742 |
|
|
|
331 |
|
Taxes |
|
|
- |
|
|
|
- |
|
Amortization of acquired intangible assets |
|
|
1,065 |
|
|
|
814 |
|
EBITDA |
|
|
(2,266 |
) |
|
|
(9,297 |
) |
|
|
|
|
|
Non-GAAP Adjusted EBITDA: |
|
|
|
|
Non-Cash Components: |
|
|
|
|
Share-based compensation |
|
|
1,323 |
|
|
|
1,406 |
|
Non-core & Infrequent
Components: |
|
|
|
|
Short-term R&D (includes one-time DFD-29 license and milestone
payments) |
|
39 |
|
|
|
7,740 |
|
Foreign exchange transaction losses |
|
|
7 |
|
|
|
21 |
|
Severance |
|
|
- |
|
|
|
141 |
|
Non-GAAP Adjusted EBITDA |
|
$ |
(897 |
) |
|
$ |
11 |
|
|
|
|
|
|
Net
loss & Non-GAAP Adjusted EBITDA per common share: |
|
|
|
|
Basic |
|
|
|
|
GAAP Net Loss |
|
$ |
(0.18 |
) |
|
$ |
(0.53 |
) |
Non-GAAP Adjusted EBITDA |
|
$ |
(0.04 |
) |
|
$ |
0.00 |
|
Diluted |
|
|
|
|
GAAP Net Loss |
|
$ |
(0.18 |
) |
|
$ |
(0.53 |
) |
Non-GAAP Adjusted EBITDA |
|
$ |
(0.04 |
) |
|
$ |
0.00 |
|
Weighted average number of common shares: |
|
|
|
|
GAAP - Basic
& Diluted |
|
|
22,611,040 |
|
|
|
19,757,449 |
|
Non-GAAP -
Basic |
|
|
22,611,040 |
|
|
|
19,757,449 |
|
Non-GAAP -
Diluted |
|
|
22,611,040 |
|
|
|
23,355,226 |
|
- The Company’s
non-GAAP results in the table above reflect an Adjusted EBITDA loss
of $0.9 million, or $(0.04) per share basic and diluted, for the
first quarter of 2025, compared to Adjusted EBITDA income of
$11,000, or $0.00 per share basic and diluted, for the first
quarter of 2024.
- Adjusted
EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per
share diluted are non-GAAP financial measures, each of which are
reconciled to the most directly comparable financial measures
calculated in accordance with GAAP above.
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