Doxycycline

FDA Approval of Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) for Rosacea Emrosi Initial Distribution Ongoing; First Prescriptions Filled Total Revenues for the Full Year Ended December 31, 2024 were $56.1 million Met All Financial Guidance for 2024 Emrosi Phase 3 Clinical Trial Results Published in JAMA Dermatology Company to Hold Conference Call Today at 4:30 p.m. ET SCOTTSDALE, Ariz., March 26, 2025 (GLOBE NEWSWIRE) -- 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 full year ended December 31, 2024. Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “We delivered a solid performance in 2024, meeting all of our financial guidance ranges and received first cycle FDA approval for Emrosi™ in November, ahead of the scheduled PDUFA date. Emrosi’s superb Phase 3 clinical results demonstrated its best-in-class profile, and we expect it will become the standard of care and transform our business. Our cash position remains strong ahead of Emrosi’s launch and our objective is to deliver enhanced revenue growth and become sustainably EBITDA positive. I am pleased to report that we have begun distribution of Emrosi, that first prescriptions have been dispensed and that we continue to execute ahead of schedule, with full promotion expected in April 2025.” 2024 Financial Guidance: 2024 Financial Results: Total revenues were $56.1 million for the full year 2024 compared to $79.2 million for the full year of 2023. Product revenue, net decreased $4.5 million, or 8%, to $55.1 million for 2024, from $59.7 million for 2023, due to overall higher rebates costs across the Company’s product portfolio and lower unit sales volumes, mainly from our legacy products. Increases in unit sales volumes for Qbrexza® and Accutane® were offset by higher rebate costs. Other revenue for 2023 reflects a one-time upfront license payment of $19.0 million and $0.5 million in product related royalties for Qbrexza from Maruho Ltd., our exclusive licensing partner in Japan. 2024 reflects a $1.0 million milestone payment pursuant to Journey’s license agreement with Cutia Therapeutics (HK) Limited (“Cutia”) that became payable to us upon Cutia receiving marketing approval for Amzeeq® in the People’s Republic of China. Cost of goods sold (“COGS”) decreased by $2.0 million, or 9%, to $20.9 million for 2024, from $22.9 million for 2023 due to a decrease in product royalties, stemming from the contractual royalty decreases in 2023 and the discontinuation of Ximino. The Company’s gross margin percentage slightly improved from period-to-period, as the cost savings noted above were partially offset by higher product COGS. SG&A expenses decreased by $3.7 million, or 8%, to $40.2 million for 2024, from $43.9 million for 2023. The decrease is mainly due to expense reduction efforts primarily in sales and marketing, partially offset by increases in non-cash share-based compensation expense, Emrosi launch expenses, and increased SG&A related to the expansion of our market access and coverage platforms. R&D expenses were $9.9 million for 2024, compared to $7.5 million for 2023. R&D expenses for 2024 include a $4.1 million application filing fee payment to the FDA for Emrosi, and a $3.0 million milestone payment triggered by the FDA’s acceptance of the Company’s NDA application for Emrosi. Clinical trial expenses were significantly lower than 2023, as clinical development for Emrosi concluded in 2024. The Company’s net loss was $(14.7) million, or $(0.72) per share basic and diluted for the full year 2024, compared to the net loss of $(3.9) million or $(0.21) per share basic and diluted for the full year 2023. Net loss for 2023 includes revenue from the Maruho upfront fee license payment of $19.0 million and $0.5 million in product related royalties. The Company’s non-GAAP results in the table below reflect Adjusted EBITDA of $0.8 million, or $0.04 per share basic and $0.03 per share diluted for the full year 2024. This compares to Adjusted EBITDA of $15.6 million, or $0.85 per share basic and $0.75 per share diluted for the full year 2023. 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 below. At December 31, 2024, Journey Medical’s cash and cash equivalents totaled $20.3 million, compared to $22.5 million on September 30, 2024, and $27.4 million on December 31, 2023, a decrease of $2.2 million for the quarter and a decrease of $7.1 million from the prior-year period. Recent Corporate Highlights: In March 2025, Journey Medical announced publication in the Journal of the American Medical Association - Dermatology of the Phase 3 clinical trial results of Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) to treat rosacea. Emrosi achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks. 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, here. In November 2024, the U.S. FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults. In October 2024, clinical data were presented at the 44th Fall Clinical Dermatology Conference assessing the dermal and systemic pharmacokinetics of Emrosi versus oral Doxycycline 40 mg capsules (Oracea®)1 in healthy subjects. 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 expertise across many industries, including healthcare. In April 2024, Journey Medical appointed Joseph M. Benesch as its permanent Chief Financial Officer. Mr. Benesch served as Journey Medical’s Interim Chief Financial Officer since January 2023 and previously, he was Corporate Controller at the Company since November 2021. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on March 26, 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/10197674/feaf5b7354. 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) 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 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 Use of Non-GAAP Measures: In addition to the GAAP financial measures as presented in our Form 10-K 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. Gain on Extinguishment of Debt: We exclude the gain on extinguishment of debt to settle amounts owed as part of license installment payments, because we consider this to be a non-cash, non-recurring item. 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. Loss Recovery: We exclude the loss recovery payment because we consider this to be a one-time, non-recurring source of income. 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: Released March 26, 2025

NEW YORK--(BUSINESS WIRE)--Wisp, the largest pure play women's telehealth company in the U.S. focused on providing sexual and reproductive health solutions, now serving more than 1.4 million patients, today launched the first-ever Male BV Partner Treatment. This launch comes in response to new evidence supporting that bacterial vaginosis (BV) can be sexually transmitted. Wisp patients and their partners can now access this two part paired prescription regimen that, in recent findings, has shown to be effective in treating this infection. 1 in 3 women are affected by BV with 60 percent of BV cases recurring within a year. This may be due to the fact that male partners were not being tested nor treated for the infection, passing BV back and forth. Recent research in a peer-reviewed medical journal found that combined oral and topical antimicrobial therapy for male partners in addition to first-line treatment of women for BV resulted in a lower rate of recurrence of the infection within 12 weeks compared to standard antibiotic care delivered to females alone. “For too long, BV has been thought of as a women’s-only issue, leaving the sexual partner untreated and women stuck in a long, frustrating cycle of antibiotics," said Monica Cepak, Wisp CEO. “This decision to quickly act on new research reflects Wisp's commitment to advancing women’s health, improving access to treatment, and advocating for improved care outcomes. We will continue to monitor emerging data to ensure safe and effective treatment options are available to our patients.” Wisp’s treatment recommendation is for patients assigned male at birth, who are in an ongoing sexual relationship with a partner assigned female at birth, who is receiving prescription treatment or a confirmed current diagnosis for BV. Patients who have stated that they wish to receive treatment alongside their female partners to help positively impact treatment outcomes for their female partner with topical Clindamycin and oral Metronidazole are prescribed oral Metronidazole 500 milligrams twice daily for seven days along with Topical Clindamycin 2 percent cream 2.5 grams topically to the external penile skin twice daily for seven days. Both of these treatments should be taken together simultaneously for the full seven days. “At Wisp, we’re committed to advancing women's health by improving access to innovative treatment options. Emerging high-quality evidence shows that combining oral Metronidazole and topical Clindamycin for male partners may have a positive impact on limiting female bacterial vaginosis. We believe this proactive approach has the potential to improve outcomes for you and your partner,” said Dr. Jillian Lopiano, OBGYN & Chief Health Officer at Wisp. Consistently being the first to bring innovative solutions to market, Wisp has pioneered the launch of products like DoxyPEP in response to CDC recommendations in 2023 supporting the use of the ‘morning after pill’ to treat STIs. These quick reactions underscore Wisp’s commitment to serving patients with best-in-class treatments that are accessible and affordable. With BV being the provider’s largest category, Wisp continues to see massive demand for products that address this infection as the category continues to grow at high rates year-over-year. The company looks to expand offerings in this category, with plans to launch its diagnostics vertical later this year. ABOUT WISP: Wisp is the largest pure play women’s telehealth company in the U.S. focused on providing sexual and reproductive health solutions to its more than 1.4 million patients in all 50 states. Offering discreet treatments online with a comprehensive selection of first-to-market products and telehealth services, Wisp has solidified itself as the one-stop shop for all women’s health needs. Wisp is committed to making women’s healthcare more inclusive, cost-effective, and accessible for all, addressing all stages of her healthcare journey, from her birth control, to fertility, menopause, STI diagnostics, weight care and more. Wisp has been named Fast Company’s Most Innovative Companies of 2023 and Inc.’s Best in Business in 2024. Wisp is a growing and profitable company and is majority-owned by WELL Health Technologies Corp. To learn more, please visit hellowisp.com or follow @hellowisp on Facebook, Instagram, TikTok and YouTube.