Full Press Release Details
Journey Medical Corporation
Reports Third Quarter 2023 Financial Results and Recent Corporate Highlights
Company generated total net
revenues of $34.5 million in the third quarter of 2023, a 101% increase from $17.2 million in the second quarter of 2023
GAAP net income increased
to $16.8 million, or $0.91 per share basic and $0.80 per share diluted, for the third quarter of 2023, compared to a GAAP net loss of
$10.1 million, or $0.57 per share basic and diluted for the third quarter of 2022
an upfront payment of $19.0 million upon entering into an exclusive license agreement with Maruho Co., Ltd. for Qbrexza in South
Korea and other Asian nations
New Drug Application
for DFD-29 expected to be submitted to FDA around the end of 2023
Company to hold conference call
today at 4:30 p.m. ET
Scottsdale, AZ - November 7, 2023
- Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical" or "the Company"), 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, 2023.
Claude Maraoui, Journey Medical's
Co-Founder, President and Chief Executive Officer, said, "In the third quarter of 2023, our total net revenues, which included the
Maruho Co., Ltd. ("Maruho") out-licensing upfront payment, were $34.5 million, a 101% increase from $17.2 million in the second
quarter, and a 114% increase from $16.1 million in the third quarter of 2022. We are also extremely pleased with the positive topline
results from our two Phase 3 clinical trials evaluating DFD-29 for the treatment of rosacea. We expect to submit a New Drug Application
("NDA") to the FDA for DFD-29 around year-end."
Recent Corporate Highlights:
| Proportion of Subjects with at Least a 2-Grade Reduction in CEA | ||||
| STUDY | DFD-29 (40 mg) | Placebo | Difference (95% CI) | P-values |
| MVOR-1 | 39/122 (31.7%) | 11/80 (13.8%) | 18.1% (7.32%, 28.96%) | 0.006 |
| MVOR-2 | 30/123 (24.5%) | 10/82 (12%) | 13.9% (3.71%, 23.99%) | 0.023 |
Conference Call and Webcast Information
Journey Medical management will conduct a conference call and
audio webcast on Tuesday, November 7, 2023, 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/10183424/fab4c8de00. 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,
and will remain available for replay for approximately 30 days after the meeting.
About Journey Medical Corporation
Journey Medical Corporation (Nasdaq: DERM) ("Journey
Medical") is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug
Administration-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales
and marketing model. The company currently markets eight 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
Forward-Looking Statements
This 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 development and regulatory approval of the DFD-29
product candidate 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, 2022, 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.
Jaclyn Jaffe (781) 652-4500
Media Relations Contact:
Tony Plohoros 6 Degrees
JOURNEY MEDICAL CORPORATION
Unaudited Condensed Consolidated
($ in thousands except for share
and per share amounts)
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 24,749 | $ | 32,003 | ||||
| Accounts receivable, net of reserves | 7,989 | 28,208 | ||||||
| Inventory | 11,024 | 14,159 | ||||||
| Prepaid expenses and other current assets | 924 | 3,309 | ||||||
| Total current assets | 44,686 | 77,679 | ||||||
| Intangible assets, net | 21,102 | 27,197 | ||||||
| Operating lease right-of-use asset, net | 124 | 189 | ||||||
| Other assets | 6 | 95 | ||||||
| Total assets | $ | 65,918 | $ | 105,160 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 28,164 | $ | 36,570 | ||||
| Due to related party | 1,093 | 413 | ||||||
| Accrued expenses | 16,026 | 19,388 | ||||||
| Accrued interest | - | 160 | ||||||
| Income taxes payable | 130 | 35 | ||||||
| Line of credit | - | 2,948 | ||||||
| Deferred cash payment (net of discount of $9) | - | 4,991 | ||||||
| Installment payments - licenses, short-term | 3,000 | 2,244 | ||||||
| Operating lease liability, short-term | 97 | 83 | ||||||
| Total current liabilities | 48,510 | 66,832 | ||||||
| Term loan, long-term (net of debt discount of $174) | - | 19,826 | ||||||
| Installment payments - licenses, long-term | - | 1,412 | ||||||
| Operating lease liability, long-term | 34 | 108 | ||||||
| Total liabilities | 48,544 | 88,178 | ||||||
| Stockholders' equity | ||||||||
| Common stock, $.0001 par value, 50,000,000 shares authorized, 12,496,782 and 11,765,700 shares issued and outstanding as of September 30, 2023 and December 31, 2022, 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, 2023 and December 31, 2022 | 1 | 1 | ||||||
| Additional paid-in capital | 87,584 | 85,482 | ||||||
| Accumulated deficit | (70,212 | ) | (68,502 | ) | ||||
| Total stockholders' equity | 17,374 | 16,982 | ||||||
| Total liabilities and stockholders' equity | $ | 65,918 | $ | 105,160 |
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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product revenue, net | $ | 15,279 | $ | 16,043 | $ | 44,405 | $ | 55,074 | ||||||||
| Other revenue | 19,260 | 73 | 19,519 | 2,629 | ||||||||||||
| Total revenue | 34,539 | 16,116 | 63,924 | 57,703 | ||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of goods sold - product revenue | 6,429 | 7,221 | 20,645 | 23,057 | ||||||||||||
| Research and development | 2,229 | 2,812 | 6,036 | 6,687 | ||||||||||||
| Selling, general and administrative | 8,636 | 15,575 | 34,069 | 45,481 | ||||||||||||
| Loss on impairment of intangible assets | - | - | 3,143 | - | ||||||||||||
| Total operating expenses | 17,294 | 25,608 | 63,893 | 75,225 | ||||||||||||
| Income (loss) from operations | 17,245 | (9,492 | ) | 31 | (17,522 | ) | ||||||||||
| Other expense (income) | ||||||||||||||||
| Interest income | (8 | ) | (3 | ) | (209 | ) | (10 | ) | ||||||||
| Interest expense | 268 | 559 | 1,674 | 1,402 | ||||||||||||
| Foreign exchange transaction losses | 101 | 22 | 181 | 22 | ||||||||||||
| Total other expense (income) | 361 | 578 | 1,646 | 1,414 | ||||||||||||
| Income (loss) before income taxes | 16,884 | (10,070 | ) | (1,615 | ) | (18,936 | ) | |||||||||
| Income tax expense | 95 | 10 | 95 | 50 | ||||||||||||
| Net income (loss) | $ | 16,789 | $ | (10,080 | ) | $ | (1,710 | ) | $ | (18,986 | ) | |||||
| Net income (loss) per common share: | ||||||||||||||||
| Basic | $ | 0.91 | $ | (0.57 | ) | $ | (0.09 | ) | $ | (1.09 | ) | |||||
| Diluted | 0.80 | (0.57 | ) | (0.09 | ) | (1.09 | ) | |||||||||
| Weighted average number of common shares: | ||||||||||||||||
| Basic | 18,416,368 | 17,618,064 | 18,078,437 | 17,464,561 | ||||||||||||
| Diluted | 21,034,758 | 17,618,064 | 18,078,437 | 17,464,561 |