Journey Medical Corporation (DERM) shares ended the last trading session 9.1% higher at $7.19. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 30.2% gain over the past four weeks.The sudden rise in the stock price can be attributed to the positive investor mindset regarding the increasing sales of its portfolio of marketed branded and generic drugs for the treatment of various dermatological conditions.This company ...

SCOTTSDALE, Ariz., April 01, 2025 (GLOBE NEWSWIRE) -- 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, is pleased to announce the promotion of Ramsey Alloush, currently General Counsel, to the position of Chief Operating Officer ("COO"). Mr. Allous ...

Regulatory Approvals and Market Presence - Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) was approved by the FDA on November 1, 2024, for treating inflammatory lesions of rosacea in adults, with sales promotion expected to begin in April 2025[30]. - Qbrexza (glycopyrronium 2.4% cloth) was approved by the FDA in June 2018 for treating primary axillary hyperhidrosis in patients aged nine and older[42]. - Zilxi (1.5% minocycline foam) was approved by the FDA in May 2020 and became available in pharmacies nationwide in October 2020[37]. - Amzeeq (4% minocycline foam) was approved by the FDA in October 2019 and became available in pharmacies in January 2020[52]. - Emrosi received FDA approval on November 1, 2024, for the treatment of inflammatory lesions of rosacea, following a collaboration that included two Phase 3 studies[89]. Market Dynamics and Competition - The topical rosacea market had over 4.3 million prescriptions in 2024, while the oral rosacea market had more than 700,000 prescriptions according to Symphony Health[38]. - The PAH market had approximately 485,000 prescriptions in 2024, excluding over-the-counter clinical strength anti-perspirants[43]. - The oral isotretinoin market had just under 2.3 million prescriptions in 2024 according to Symphony Health[49]. - The topical acne market had more than 23.5 million prescriptions in 2024, indicating significant unmet needs in patient treatment[53]. - The current U.S. market size for acne treatment is estimated at approximately $3 billion annually according to the American Medical Association[46]. - The company faces significant competition from larger pharmaceutical and biotechnology firms, which have greater capital resources and experience in drug development[104]. - The dermatology sector is highly fragmented, with numerous midsize and smaller companies competing in both prescription and OTC markets[105]. - The company may face increased competition from generic pharmaceutical manufacturers once patents expire or are challenged[108]. - The majority of sales derive from products without patent protection, exposing the company to significant competition and potential adverse impacts on operating income[155]. - Accutane competes in the Isotretinoin market with five other AB rated products, while Targadox faces AB rated generic competition[155]. Financial Transactions and Business Development - The company received a one-time upfront license payment of $19.0 million from Maruho Ltd. in 2023[72]. - The company acquired Vyne's Molecule Stabilizing Technology™ franchise for an upfront payment of $20.0 million, with potential milestone payments totaling up to $450.0 million[75]. - The company paid a $15.0 million milestone payment to DRL in December 2024 following FDA approval of Emrosi[76]. - On March 31, 2021, the company executed an asset purchase agreement for Qbrexza, making an upfront cash payment of $12.5 million and potential milestone payments of up to $144.0 million[77]. - The company entered into a license and supply agreement for Accutane, with an upfront payment of $1.0 million and additional milestone payments totaling $4.0 million, along with low-double digit royalties based on net sales[82]. - The Anti-itch Product agreement involved total consideration of $4.0 million, with no additional payment obligations beyond the initial payments, and the product is expected to launch in the second half of 2025 or first half of 2026[84]. - On August 31, 2023, the company entered into a New License Agreement with Maruho, receiving a non-refundable upfront payment of $19.0 million for exclusive rights to Qbrexza in multiple Asian territories[87]. - The company received a $1.0 million milestone payment from Cutia Therapeutics upon the marketing approval of topical 4% minocycline foam in China[88]. Compliance and Regulatory Challenges - The regulatory approval process for new drugs is lengthy, expensive, and uncertain, requiring extensive pre-clinical and clinical data submission to the FDA[113]. - The company must comply with strict cGMP regulations, and any non-compliance by contract manufacturers could lead to product recalls or production delays[110]. - Compliance with FDA regulations and cGMP is critical, as failure to comply may prevent the company from marketing affected products[128]. - The FDA may require post-marketing studies to assess long-term risks and benefits of drugs, adding to the regulatory burden[119]. - The company is subject to various federal and state laws targeting healthcare fraud, which could lead to significant penalties for violations[140]. - The company has established a corporate compliance program to prevent violations of healthcare laws, ensuring adherence to industry standards[138]. - Violations of healthcare regulations could lead to severe penalties, including fines and withdrawal of product approvals[178]. - The company faces increased scrutiny from the OIG regarding sales through specialty pharmacies, which may hinder product sales due to enforcement risks[179]. - The company may incur substantial costs to ensure compliance with healthcare laws and regulations, which could impact operational efficiency[181]. Product Development and Clinical Trials - The company is focused on developing and commercializing therapies for dermatologic conditions to maximize long-term value creation[62]. - The company is actively seeking new business development opportunities, including acquiring development stage and commercial drugs[63]. - Patient enrollment challenges in clinical trials could delay regulatory approvals and increase development costs for future product candidates[197]. - The company expects to rely on third parties for conducting future clinical trials, which may not perform satisfactorily and could delay product approvals[213]. - The accuracy of clinical data obtained from third parties is crucial; inaccurate data could compromise research and development efforts[218]. Risks and Liabilities - Product liability claims pose a risk, potentially leading to substantial liabilities and limiting the commercialization of products[219]. - The company began marketing Accutane®, an isotretinoin product, in Q2 2021, which has historically faced significant product liability claims[222]. - The company is exposed to risks from regulatory investigations related to compliance issues, which could affect its operations and reputation[220]. - The company may face challenges in maintaining product liability insurance coverage, which could impact financial stability if claims arise[221]. - The company has substantial defenses against potential isotretinoin product liability claims due to previous court rulings[222]. Future Outlook and Strategic Considerations - Future growth may depend on the company's ability to identify and acquire or in-license products, with potential operational and financial risks involved[229]. - The company has limited resources to execute acquisitions or in-licensing of products, which may cause it to miss viable commercial opportunities[230]. - The company anticipates that additional healthcare reform measures may limit government payments for healthcare products, leading to reduced demand[187]. - Future revenue from sales may be lower than expected due to competition and market dynamics affecting dermatology products[151]. - The commercial success of products depends on acceptance by the medical community and coverage by third-party payors, which may be limited by clinical study outcomes and regulatory approvals[203]. - Market acceptance could be hindered by adverse side effects and the need for significant resources to educate the medical community on new products[204].

Journey Medical Corporation (NASDAQ:DERM) Q4 2024 Results Conference Call March 26, 2025 4:30 PM ET Company Participants Jaclyn Jaffe - Senior Director, Corporate Operations Claude Maraoui - Co-Founder, President and CEO Joseph Benesch - Chief Financial Officer Louis Donati - Director of Market Access Srini Sidgiddi - Vice President, Research and Development Ramsey Alloush - General Counsel and Corporate Secretary Conference Call Participants Thomas Flaten - Lake Street Capital Markets Scott Henry - AGP Bra ...

Group 1: Earnings Performance - Journey Medical Corporation reported quarterly earnings of $0.08 per share, surpassing the Zacks Consensus Estimate of a loss of $0.22 per share, and improving from a loss of $0.12 per share a year ago, representing an earnings surprise of 136.36% [1] - Over the last four quarters, the company has exceeded consensus EPS estimates two times [2] - The company posted revenues of $13.62 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 1.84%, and down from $15.26 million year-over-year [2] Group 2: Stock Performance and Outlook - Journey Medical shares have increased approximately 65.7% since the beginning of the year, while the S&P 500 has declined by 1.8% [3] - The future performance of the stock will largely depend on management's commentary during the earnings call and the company's earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.05 on revenues of $10.39 million, and for the current fiscal year, it is $0.15 on revenues of $74.53 million [7] Group 3: Industry Context - The Medical - Drugs industry, to which Journey Medical belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Market Opportunity - Approximately 16.5 million Americans suffer from rosacea, with only 2-3 million currently receiving treatment, indicating a significant market opportunity[19][39]. - The total addressable market for rosacea treatments is expanding, with a significant portion of patients not currently receiving adequate care[41]. - The U.S. population of approximately 345 million includes around 242 million lives covered by commercial, government, and Medicare plans, highlighting a significant market opportunity[96]. Product Efficacy and Safety - Emrosi received FDA approval in November 2024, demonstrating superior efficacy compared to both placebo and the market-leading oral rosacea treatment, Oracea[10]. - Emrosi's clinical trials showed a treatment success rate of 28.2% at week 16, significantly outperforming Oracea and placebo with a p-value of <0.001[30][31]. - Emrosi's safety profile is comparable to placebo, with most treatment-related adverse events reported as mild or moderate[32]. - Emrosi is positioned as the best-in-class oral therapy for inflammatory lesions of rosacea, with a unique mix of patient benefits including head-to-head superiority over Oracea demonstrated in two Phase 3 trials[74]. Market Demand and Sales Strategy - The oral rosacea market is projected to have over 712,000 prescriptions filled in 2024, highlighting the growing demand for effective treatments[45]. - Journey Medical has established a dedicated dermatology sales force to capitalize on the commercial potential of Emrosi[10]. - Journey Medical's sales force can cover 83% of Oral Rosacea prescriptions at launch, with 547,349 total prescriptions expected in 2024[51]. - The market is highly concentrated, with 3,127 writers responsible for 80% of prescriptions, averaging 48 prescriptions per writer[53]. - 74% of surveyed high rosacea prescribers believe Emrosi is "very likely" to be prescribed, indicating strong market interest[67]. Launch and Marketing Plans - Emrosi's launch is scheduled for April 2025, following FDA approval and payer notifications[99]. - Journey Medical aims to establish Emrosi as the oral standard of care through targeted HCP digital advertising and educational programs[65][90]. - The company plans to exhibit at the AAD 2025 conference and utilize KOLs to promote Emrosi among healthcare providers[89]. Financial and Research Initiatives - The company plans to pursue out-licensing opportunities to generate additional cash flow and future revenue streams[10]. - Journey Medical is committed to ongoing research, with multiple manuscript submissions planned for leading peer-reviewed journals covering safety, efficacy, and quality of life improvements[35]. Pricing Sensitivity - HCPs are sensitive to patient out-of-pocket costs above $50 per month, which may impact prescription rates[70].

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” ...

Core Insights - Journey Medical Corporation has launched Emrosi™, a new treatment for inflammatory lesions of rosacea, and the first prescriptions have been filled [2][3] - Emrosi is the lowest-dose oral minocycline available, showing superior clinical outcomes compared to Oracea and placebo while maintaining a comparable safety profile [3] - The FDA approved Emrosi for the treatment of rosacea in November 2024, marking a significant milestone for Journey Medical [3] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [7] - The company currently markets eight branded and two generic products aimed at treating common skin conditions [7] - Founded by Fortress Biotech, Inc., Journey Medical is based in Scottsdale, Arizona, and is publicly traded on Nasdaq under the ticker DERM [7] Industry Context - Rosacea is a chronic inflammatory skin condition affecting over 16 million Americans and approximately 415 million people worldwide [6] - The condition often leads to significant impacts on self-esteem and social interactions, with many patients reporting adverse effects on their professional lives [6] - The launch of Emrosi addresses a substantial unmet need in the treatment of rosacea, which is prevalent among adults aged 30 to 50 [6]

Jaclyn Jaffe Journey Medical Corporation (781) 652-4500 ir@jmcderm.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com 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 FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Compa ...

SCOTTSDALE, Ariz., March 12, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation (“Journey Medical”) (Nasdaq: DERM), 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 that management will participate in the 37th Annual ROTH Conference, which is being held March 16-18, 2025 in Dana Point, California. Claude Maraoui, Pr ...