Core Viewpoint - Journey Medical Corporation has promoted Ramsey Alloush to Chief Operating Officer, reflecting his leadership and critical role in the company's growth, particularly with the upcoming launch of Emrosi™ [2][3] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on selling and marketing FDA-approved prescription products for dermatological conditions [3] - The company currently markets eight FDA-approved prescription drugs aimed at treating common skin conditions [3] - Founded by Fortress Biotech, Inc., Journey Medical is located in Scottsdale, Arizona and is publicly traded on NASDAQ under the ticker DERM [3] Leadership and Strategic Initiatives - Ramsey Alloush, who joined Journey Medical in 2020 as General Counsel, has over 15 years of experience in the pharmaceutical industry and has played a significant role in the company's regulatory and corporate governance matters [2] - Alloush's promotion to COO is expected to enhance operational capabilities and drive strategic initiatives that deliver value to patients, partners, and shareholders [2] - The imminent launch of Emrosi™ is seen as a pivotal moment for the company, with expectations to set a new standard of care in dermatology [2]

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].

Financial Data and Key Metrics Changes - Journey Medical reported annual revenue of $56 million in 2024, a decrease from $79 million in 2023, primarily due to higher rebate costs and lower unit volumes from legacy products [25][26] - The total net product revenue for 2024 was $55.1 million, compared to $59.7 million in 2023 [25][26] - The net loss for 2024 was $14.7 million or $0.72 per share, compared to a net loss of $3.9 million or $0.21 per share in 2023 [29] - Non-GAAP adjusted EBITDA for 2024 was positive $800,000 or $0.04 per share, down from $15.6 million or $0.85 per share in 2023 [30][31] - Cash and cash equivalents at the end of 2024 were $20.3 million, down from $27.4 million at the end of 2023 [31] Business Line Data and Key Metrics Changes - Research and development expenses increased by $2.3 million to $9.9 million in 2024, driven by non-recurring payments related to MROSI [27][28] - Selling, general and administrative (SG&A) expenses decreased by $3.7 million or 8% to $40.2 million in 2024, attributed to expense optimization efforts [29] Market Data and Key Metrics Changes - MROSI is entering a treatment category valued at over $1 billion, with expectations of significant operating leverage as it gains market traction [12] - As of early 2025, commercial payer coverage for MROSI increased to approximately 20% of 188 million commercial lives and 4% of 58 million Medicare lives [17] Company Strategy and Development Direction - The company is focused on the launch of MROSI, which is expected to be a major growth driver, with peak annual sales estimated at $200 million in the U.S. and $100 million internationally [33] - Journey Medical plans to continue attending and presenting at dermatology-focused medical congresses throughout 2025 to promote MROSI [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the launch of MROSI, highlighting its superior clinical results and the potential to transform the treatment of rosacea [32] - The company anticipates a ramp-up in payer coverage and prescription demand throughout 2025, with a focus on achieving sustainable positive EBITDA and profitability [34] Other Important Information - Journey Medical completed a total of $22 million in FDA filing fees and milestone payments related to MROSI in 2024 [10] - The company received a $1 million milestone payment upon Cutia Therapeutics receiving regulatory approval to market AmZEEK in China [26] Q&A Session Summary Question: Expectations for payer coverage by the end of 2025 - Management expects peak commercial coverage to take 12 to 18 months, with ongoing efforts to increase covered lives [38][41] Question: Importance of erythema data from KOL interactions - The head-to-head performance data was of significant interest to physicians, while erythema data was less emphasized [42][44] Question: 2025 guidance and early prescription data - Management plans to provide 2025 financial guidance later in the year after assessing initial prescription demand [52][53] Question: Reimbursement environment and early prescription fill rates - Early indications show that prescription fill rates are on target, with around 20% coverage currently [55][56] Question: Pricing strategies for legacy products - Pricing for legacy brands is expected to remain steady, with some erosion in volume due to competition [79][80] Question: Milestones for MROSI launch and potential bottlenecks - Key focus areas include supply and formulary coverage, with management optimistic about progress [85][88] Question: International licensing opportunities for MROSI - The company is looking to out-license MROSI internationally after establishing a strong presence in the U.S. [90][91]

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]

Journey Medical Corp (DERM) Q4 2024 Earnings Call March 26, 2025 04:30 PM ET Company Participants Jaclyn Jaffe - Senior Director of Corporate OperationsClaude Maraoui - Co-Founder, President and Chief Executive OfficerJoseph Benesch - CFOLouis Donati - Director - Market AccessSrinivas Sidgiddi - Vice President - Research & DevelopmentBrandon Folkes - Managing Director - Equity Research Conference Call Participants Thomas Flaten - Senior Research AnalystScott Henry - Managing Director & Senior Research Analy ...

Journey Medical Corp (DERM) Q4 2024 Earnings Call March 26, 2025 04:30 PM ET Company Participants Jaclyn Jaffe - Senior Director of Corporate OperationsClaude Maraoui - Co-Founder, President and Chief Executive OfficerJoseph Benesch - CFOLouis Donati - Director - Market AccessSrinivas Sidgiddi - Vice President - Research & DevelopmentBrandon Folkes - Managing Director - Equity Research Conference Call Participants Thomas Flaten - Senior Research AnalystScott Henry - Managing Director & Senior Research Analy ...

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].

Core Insights - Journey Medical Corporation achieved total revenues of $56.1 million for the full year ended December 31, 2024, meeting all financial guidance for the year [4][3] - The company received FDA approval for Emrosi™ in November 2024, with initial distribution ongoing and first prescriptions filled [2][1] - Emrosi's Phase 3 clinical trial results were published in JAMA Dermatology, demonstrating its best-in-class profile [2][5] Financial Performance - Total revenues decreased by 29% from $79.2 million in 2023 to $56.1 million in 2024 [4][5] - Product revenue, net fell by 8% to $55.1 million in 2024 from $59.7 million in 2023, attributed to higher rebate costs and lower unit sales volumes [5][4] - Other revenue dropped significantly by 95% to $1.0 million in 2024, down from $19.5 million in 2023, which included a one-time license payment [5][7] Expense Overview - Cost of goods sold decreased by 9% to $20.9 million in 2024 from $22.9 million in 2023 [7] - Selling, general and administrative expenses decreased by 8% to $40.2 million in 2024, primarily due to expense reduction efforts [7] - Research and development expenses increased to $9.9 million in 2024 from $7.5 million in 2023, including significant costs related to Emrosi [7] Net Loss and Adjusted EBITDA - The company reported a net loss of $(14.7) million, or $(0.72) per share, for 2024, compared to a net loss of $(3.9) million, or $(0.21) per share, in 2023 [6][20] - Adjusted EBITDA for 2024 was $0.8 million, a significant decrease from $15.6 million in 2023 [6][26] Cash Position - As of December 31, 2024, Journey Medical's cash and cash equivalents totaled $20.3 million, down from $27.4 million at the end of 2023 [6][16] Recent Developments - The company began distribution of Emrosi and expects full promotion to commence in April 2025 [2][1] - Journey Medical hosted a conference call to discuss its U.S. commercial launch plan for Emrosi [6][9]

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]

Core Viewpoint - Journey Medical Corporation is set to release its year-end 2024 financial results on March 26, 2025, after U.S. financial markets close, followed by a conference call at 4:30 p.m. ET [1] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on selling and marketing FDA-approved prescription products for dermatological conditions [4] - The company markets seven branded and two generic products aimed at treating common skin conditions [4] - Founded by Fortress Biotech, Inc., Journey Medical is located in Scottsdale, Arizona, and is registered under the Securities Exchange Act of 1934 [4] Conference Call Details - Interested parties can listen to the conference call by dialing specific numbers for domestic and international participants, with a recommendation to join 10 minutes prior to the start time [2] - A live audio webcast will be available on the company's website and will remain accessible for approximately 30 days after the call [3]