Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or
“the Company”, “we”, or “our”), a commercial-stage pharmaceutical
company that primarily focuses on the selling and marketing of 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 third quarter ended September 30, 2024.
Claude Maraoui, Journey Medical’s Co-Founder,
President and Chief Executive Officer, said, “Given the recent FDA
approval of Emrosi™, (Minocycline Hydrochloride Extended Release
Capsules, 40 mg), formerly referred to as DFD-29, for the treatment
of inflammatory lesions of rosacea in adults, we are completing
manufacturing activities and deploying our experienced dermatology
sales force to quickly enable patient access to this unique
therapeutic solution. This approval is a transformational milestone
for both Journey Medical and the dermatology community, as Emrosi
has the potential to become the best-in-class oral medication and
standard of care to address inflammatory lesions of rosacea.”
Mr. Maraoui continued, “We also continued to
commercialize our core dermatology products and experienced a solid
third quarter of 2024, with $14.6 million in revenues. We look
forward to continued growth with the anticipated launch of Emrosi
in late first quarter or early second quarter of 2025.”
Financial Results:
- Total net product revenues were
$14.6 million for the third quarter of 2024, a 4% decrease compared
to the third quarter of 2023. Qbrexza net product sales increased
by $1.7 million, or 29%, from the same period in 2023, due to our
focused marketing efforts and the expansion of our access and
coverage platforms for the product offset by decreases in sales
volume for the remainder of our products.
- Cost of goods sold decreased by
$1.1 million, or 18%, compared to the third quarter of 2023,
driving a 6.0% increase in our gross product margin from 57.9% in
the prior year quarter, to 63.9% for the third quarter of 2024. The
gross margin increase was mainly due to inventory charges recorded
in the prior year period and a decrease in product royalties from
the same period in 2023.
- Research and development costs
decreased by $1.4 million compared to the prior year quarter due to
lower clinical trial expenses to develop Emrosi.
- Selling, general and administrative
expenses increased by $2.8 million from the same period in 2023
mainly due to increases in non-cash share-based compensation
expenses and overall selling and marketing expenses, including our
pre-launch expenses for Emrosi.
- Net income for the third quarter of
2023 includes the one-time $19.0 million upfront payment received
pursuant to our license agreement with Maruho Co., Ltd. Net loss
for the third quarter of 2024 was $2.4 million, or $(0.12) per
share basic and diluted, compared to net income of $16.8 million,
or $0.91 per share basic and $0.80 per share diluted, for the third
quarter of 2023.
- Our non-GAAP results in the table
below reflect Adjusted EBITDA of $0.3 million, or $0.01 per share
basic and diluted, for the third quarter of 2024 compared to
Adjusted EBITDA of $20.8 million, or $1.13 per share basic and
$0.99 per share diluted, for the third quarter of 2023. Adjusted
EBITDA for the third quarter of 2023 includes the one-time $19.0
million upfront payment received pursuant to our license agreement
with Maruho Co., Ltd. Adjusted EBITDA, Adjusted EBITDA per share
basic and Adjusted EBITDA per share diluted are non-GAAP financial
measures, each of which is reconciled to the most directly
comparable financial measures calculated in accordance with GAAP
below under “Use of Non-GAAP Measures.”
- At September 30, 2024, the Company
had $22.5 million in cash and cash equivalents, as compared to
$23.9 million at June 30, 2024.
Recent Corporate
Highlights:
- In November 2024, the U.S. FDA
approved Emrosi (Minocycline Hydrochloride Extended Release
Capsules, 40 mg) for the treatment of inflammatory lesions of
rosacea in adults.
- In October 2024, clinical data was
presented at the 44th Fall Clinical Dermatology Conference
assessing the dermal and systemic pharmacokinetics of Emrosi versus
oral Doxycycline 40 mg capsules (Oracea®) in healthy subjects. With
its extended-release formulation, Emrosi provides higher dermal
concentration than doxycycline from Day 1 onward at a similar dose,
expected to translate into a clinically meaningful impact for
treating patients with rosacea, and as demonstrated in Emrosi’s
Phase 3 clinical trials.
- In July 2024, Journey Medical
appointed Michael C. Pearce to its Board of Directors. Mr. Pearce
is an accomplished executive, with substantial strategic, business
and financial experience across many industries, including
healthcare.
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 seven branded and two generic
products 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, 2023,
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 |
($ in thousands
except for share and per share amounts) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
2024 |
|
2023 |
ASSETS |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
22,461 |
|
|
$ |
27,439 |
|
Accounts receivable, net of reserves |
|
10,671 |
|
|
|
15,222 |
|
Inventory |
|
11,788 |
|
|
|
10,206 |
|
Prepaid expenses and other current assets |
|
1,242 |
|
|
|
3,588 |
|
Total
current assets |
|
46,162 |
|
|
|
56,455 |
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
17,844 |
|
|
|
20,287 |
|
Operating lease right-of-use asset, net |
|
32 |
|
|
|
101 |
|
Other assets |
|
6 |
|
|
|
6 |
|
Total assets |
$ |
64,044 |
|
|
$ |
76,849 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
15,339 |
|
|
$ |
18,149 |
|
Due to related party |
|
370 |
|
|
|
195 |
|
Accrued expenses |
|
16,008 |
|
|
|
20,350 |
|
Accrued interest |
|
332 |
|
|
|
22 |
|
Income taxes payable |
|
- |
|
|
|
53 |
|
Installment payments – licenses, short-term |
|
1,250 |
|
|
|
3,000 |
|
Operating lease liability, short-term |
|
34 |
|
|
|
99 |
|
Total
current liabilities |
|
33,333 |
|
|
|
41,868 |
|
|
|
|
|
|
|
|
|
Term loan,
long-term, net of debt discount |
|
19,785 |
|
|
|
14,622 |
|
Operating
lease liability, long-term |
|
- |
|
|
|
9 |
|
Total liabilities |
|
53,118 |
|
|
|
56,499 |
|
|
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
|
|
|
|
Common stock, $.0001 par value, 50,000,000 shares authorized,
14,728,904 and 13,323,952 shares issued and outstanding as of
September 30, 2024 and December 31, 2023, respectively |
|
1 |
|
|
|
1 |
|
Common stock - Class A, $.0001 par value, 50,000,000 shares
authorized, 6,000,000 shares issued and outstanding as of September
30, 2024 and December 31, 2023 |
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
99,472 |
|
|
|
92,703 |
|
Accumulated deficit |
|
(88,548 |
) |
|
|
(72,355 |
) |
Total stockholders' equity |
|
10,926 |
|
|
|
20,350 |
|
Total liabilities and stockholders' equity |
$ |
64,044 |
|
|
$ |
76,849 |
|
|
JOURNEY
MEDICAL CORPORATION |
Unaudited
Condensed Consolidated Statements of Operations |
($ in thousands
except for share and per share amounts) |
|
|
|
|
|
|
|
|
|
Three-Month
Periods Ended |
|
Nine-Month
Periods Ended |
|
September 30, |
|
September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Revenue: |
|
|
|
|
|
|
|
Product revenue, net |
$ |
14,629 |
|
|
$ |
15,279 |
|
|
$ |
42,514 |
|
|
$ |
44,405 |
|
Other revenue |
|
- |
|
|
|
19,260 |
|
|
|
- |
|
|
|
19,519 |
|
Total
revenue |
|
14,629 |
|
|
|
34,539 |
|
|
|
42,514 |
|
|
|
63,924 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Cost of goods sold – product revenue |
|
5,285 |
|
|
|
6,429 |
|
|
|
18,642 |
|
|
|
20,645 |
|
Research and development |
|
842 |
|
|
|
2,229 |
|
|
|
9,639 |
|
|
|
6,036 |
|
Selling, general and administrative |
|
11,396 |
|
|
|
8,636 |
|
|
|
30,144 |
|
|
|
34,069 |
|
Loss on impairment of intangible assets |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,143 |
|
Total
operating expenses |
|
17,523 |
|
|
|
17,294 |
|
|
|
58,425 |
|
|
|
63,893 |
|
Income
(loss) from operations |
|
(2,894 |
) |
|
|
17,245 |
|
|
|
(15,911 |
) |
|
|
31 |
|
|
|
|
|
|
|
|
|
Other expense (income) |
|
|
|
|
|
|
|
Interest income |
|
(188 |
) |
|
|
(8 |
) |
|
|
(566 |
) |
|
|
(209 |
) |
Interest expense |
|
758 |
|
|
|
268 |
|
|
|
1,869 |
|
|
|
1,674 |
|
Foreign exchange transaction losses |
|
51 |
|
|
|
101 |
|
|
|
104 |
|
|
|
181 |
|
Gain on extinguishment of debt |
|
(1,125 |
) |
|
|
- |
|
|
|
(1,125 |
) |
|
|
- |
|
Total other
expense (income) |
|
(504 |
) |
|
|
361 |
|
|
|
282 |
|
|
|
1,646 |
|
Income (loss) before income taxes |
|
(2,390 |
) |
|
|
16,884 |
|
|
|
(16,193 |
) |
|
|
(1,615 |
) |
|
|
|
|
|
|
|
|
Income tax
expense |
|
- |
|
|
|
95 |
|
|
|
- |
|
|
|
95 |
|
Net
income (loss) |
$ |
(2,390 |
) |
|
$ |
16,789 |
|
|
$ |
(16,193 |
) |
|
$ |
(1,710 |
) |
|
|
|
|
|
|
|
|
Net income
(loss) per common share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.12 |
) |
|
$ |
0.91 |
|
|
$ |
(0.80 |
) |
|
$ |
(0.09 |
) |
Diluted |
$ |
(0.12 |
) |
|
$ |
0.80 |
|
|
$ |
(0.80 |
) |
|
$ |
(0.09 |
) |
Weighted
average number of common shares: |
|
|
|
|
|
|
|
Basic |
|
20,537,794 |
|
|
|
18,416,368 |
|
|
|
20,137,942 |
|
|
|
18,078,437 |
|
Diluted |
|
20,537,794 |
|
|
|
21,034,758 |
|
|
|
20,137,942 |
|
|
|
18,078,437 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 and amortization, 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, 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 in connection with Emrosi, formerly referred to as
DFD-29, including the filing fee payment made to the FDA and
contractual milestone payments, which was the only product in our
portfolio not approved for marketing and sale during the 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 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.
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 CORPORATION |
Reconciliation of GAAP to Non-GAAP Adjusted
EBITDA |
($ in thousands
except for share and per share amounts) |
|
|
Three-Month
Periods Ended |
|
Nine-Month
Periods Ended |
|
September 30 |
|
September 30 |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
GAAP Net Loss |
$ |
(2,390 |
) |
|
$ |
16,789 |
|
$ |
(16,193 |
) |
|
$ |
(1,710 |
) |
|
|
|
|
|
|
|
|
EBITDA: |
|
|
|
|
|
|
|
Interest |
|
570 |
|
|
|
260 |
|
|
1,303 |
|
|
|
1,465 |
|
Taxes |
|
- |
|
|
|
95 |
|
|
- |
|
|
|
95 |
|
Amortization of acquired intangible assets |
|
814 |
|
|
|
814 |
|
|
2,443 |
|
|
|
2,952 |
|
EBITDA |
|
(1,006 |
) |
|
|
17,958 |
|
|
(12,447 |
) |
|
|
2,802 |
|
|
|
|
|
|
|
|
|
Non-GAAP Adjusted EBITDA: |
|
|
|
|
|
|
|
Non-Cash Components: |
|
|
|
|
|
|
|
Share-based compensation |
|
1,640 |
|
|
|
558 |
|
|
4,720 |
|
|
|
2,077 |
|
Gain on extinguishment of debt |
|
(1,125 |
) |
|
|
- |
|
|
(1,125 |
) |
|
|
- |
|
Loss on impairment of intangible assets |
|
- |
|
|
|
- |
|
|
- |
|
|
|
3,143 |
|
Non-core & Infrequent Components: |
|
|
|
|
|
|
|
Short-term R&D (includes one-time DFD-29 license and milestone
payments) |
|
692 |
|
|
|
2,206 |
|
|
9,173 |
|
|
|
5,949 |
|
Foreign exchange transaction losses |
|
51 |
|
|
|
100 |
|
|
104 |
|
|
|
181 |
|
Severance |
|
- |
|
|
|
- |
|
|
147 |
|
|
|
711 |
|
Non-GAAP Adjusted EBITDA |
$ |
252 |
|
|
$ |
20,822 |
|
$ |
572 |
|
|
$ |
14,863 |
|
|
|
|
|
|
|
|
|
Net
income (loss) & Non-GAAP Adjusted EBITDA per common
share: |
|
|
|
|
|
|
|
Basic |
|
|
|
|
|
|
|
GAAP Net Loss |
$ |
(0.12 |
) |
|
$ |
0.91 |
|
$ |
(0.80 |
) |
|
$ |
(0.09 |
) |
Non-GAAP Adjusted EBITDA |
$ |
0.01 |
|
|
$ |
1.13 |
|
$ |
0.03 |
|
|
$ |
0.82 |
|
Diluted |
|
|
|
|
|
|
|
GAAP Net Loss |
$ |
(0.12 |
) |
|
$ |
0.80 |
|
$ |
(0.80 |
) |
|
$ |
(0.09 |
) |
Non-GAAP Adjusted EBITDA |
$ |
0.01 |
|
|
$ |
0.99 |
|
$ |
0.02 |
|
|
$ |
0.72 |
|
|
|
|
|
|
|
|
|
Weighted average number of common shares: |
|
|
|
|
|
|
|
GAAP -
Basic |
|
20,537,794 |
|
|
|
18,416,368 |
|
|
20,137,942 |
|
|
|
18,078,437 |
|
GAAP -
Diluted |
|
20,537,794 |
|
|
|
21,034,758 |
|
|
20,137,942 |
|
|
|
18,078,437 |
|
Non-GAAP -
Basic |
|
20,537,794 |
|
|
|
18,416,368 |
|
|
20,137,942 |
|
|
|
18,078,437 |
|
Non-GAAP -
Diluted |
|
24,762,014 |
|
|
|
21,034,758 |
|
|
24,263,348 |
|
|
|
20,588,661 |
|
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Oct 2024 to Nov 2024
Journey Medical (NASDAQ:DERM)
Historical Stock Chart
From Nov 2023 to Nov 2024