Financial Performance - Total revenues for Q1 2024 were $13.0 million, a 7% increase from $12.2 million in Q1 2023[1] - The net loss for Q1 2024 was $10.4 million, or $(0.53) per share, compared to a net loss of $10.1 million, or $(0.57) per share, in Q1 2023[9] - GAAP net loss for the three-month period ended March 31, 2024, was $10,442,000, compared to a net loss of $10,136,000 for the same period in 2023[21] - GAAP net loss per share basic and diluted for Q1 2024 was $(0.53), consistent with $(0.57) in Q1 2023[21] Revenue Growth - Year-over-year revenue growth of flagship products Qbrexza® and Accutane® exceeded 20%[2] Expenses - Research and development costs rose to $7.9 million in Q1 2024 from $2.0 million in Q1 2023, driven by a $4.0 million FDA filing fee for DFD-29[9] - Selling, general and administrative expenses decreased by $4.9 million to $8.4 million in Q1 2024 from $13.3 million in Q1 2023[9] - Share-based compensation expense increased to $1,406,000 in Q1 2024 from $646,000 in Q1 2023[21] - Short-term research and development expenses, including one-time DFD-29 application fees and milestone payments, rose to $7,740,000 in Q1 2024 from $1,999,000 in Q1 2023[21] Cash and Assets - Cash and cash equivalents decreased to $24.1 million as of March 31, 2024, down from $27.4 million at December 31, 2023[9] - Total current assets decreased to $47.0 million as of March 31, 2024, from $56.5 million at December 31, 2023[13] - Total liabilities decreased to $53.6 million as of March 31, 2024, from $56.5 million at December 31, 2023[13] FDA and Product Development - The FDA accepted the NDA for DFD-29 in March 2024, with a PDUFA goal date set for November 4, 2024[4] - DFD-29, if approved, could be the only oral therapy for treating rosacea, representing a significant commercial opportunity[4] Non-GAAP Measures - Non-GAAP Adjusted EBITDA for the three-month period ended March 31, 2024, was $11,000, a significant improvement from a loss of $5,321,000 in the same period in 2023[21] - Non-GAAP Adjusted EBITDA per share basic and diluted for Q1 2024 was $0.00, compared to $(0.30) in Q1 2023[21] - The company emphasizes that non-GAAP measures provide meaningful supplemental information regarding performance and are used by institutional investors[18] - Management excludes non-cash and non-recurring items from Adjusted EBITDA to better reflect core operating performance[19] Long-term Strategy - The company’s long-term strategy focuses on marketing and selling FDA-approved dermatological products and out-licensing intellectual property[19]

Core Insights - Journey Medical Corporation reported a 7% year-over-year revenue growth in Q1 2024, totaling $13.0 million compared to $12.2 million in Q1 2023, driven by over 20% growth in flagship products Qbrexza® and Accutane® [2][3] - The FDA accepted the New Drug Application for DFD-29, with a PDUFA goal date set for November 4, 2024, marking a significant milestone for the company [2][5] - The company experienced a net loss of $10.4 million in Q1 2024, slightly higher than the net loss of $10.1 million in Q1 2023 [3][16] Financial Performance - Total net product revenues for Q1 2024 were $13.0 million, a 7% increase from $12.2 million in Q1 2023, primarily due to increased sales of Qbrexza and Accutane, partially offset by declines in Amzeeq® and Zilxi® [3][15] - Cost of goods sold rose to $6.8 million in Q1 2024 from $6.4 million in Q1 2023, reflecting the increase in net product revenues [3] - Research and development costs surged to $7.9 million in Q1 2024 from $2.0 million in Q1 2023, driven by a $4.0 million FDA filing fee for DFD-29 and a $3.0 million milestone payment to Dr. Reddy's Laboratories [3][20] Cash Position - As of March 31, 2024, the company had $24.1 million in cash and cash equivalents, down from $27.4 million at the end of 2023 [4][12] Corporate Developments - The company is focused on launching DFD-29, which, if approved, could be the only oral therapy for treating rosacea, presenting a significant commercial opportunity [2][5] - A conference call was scheduled for May 13, 2024, to discuss financial results and provide business updates [6][8]

SCOTTSDALE, Ariz., May 07, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation ("Journey Medical" or the "Company") (NASDAQ:DERM), a commercial-stage pharmaceutical company that focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced the Company will release its first quarter 2024 financial results after the U.S. financial markets close on Monday, May 13, 2024. Journey Medical management will conduct a confere ...

SCOTTSDALE, Ariz., May 01, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation ("Journey Medical" or "the Company") (NASDAQ:DERM), 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 the appointment of Joseph M. Benesch as Chief Financial Officer, effective April 26, 2024. Mr. Benesch had served as the Company's ...

SCOTTSDALE, Ariz., April 25, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation ("Journey Medical" or "the Company") (NASDAQ:DERM), 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, announced today that Claude Maraoui, Co-Founder, President and Chief Executive Officer, will present a corporate overview at the Planet MicroCap ...

Financial Agreements and Investments - The company entered into a Credit Agreement with SWK Funding LLC, providing a term loan facility of up to $20.0 million, with an initial draw of $15.0 million[30]. - A license agreement was established with Maruho Co., Ltd., granting exclusive rights for Qbrexza® in several Asian markets, with a non-refundable upfront payment of $19.0 million[31]. - The company received a one-time upfront license payment of $19.0 million from Maruho in 2023[72]. - Fortress paid $19.0 million as a non-refundable upfront payment for the exclusive rights to Qbrexza in the Territory[75]. - The acquisition of Vyne's Molecule Stabilizing Technology™ franchise included an upfront payment of $20.0 million and potential milestone payments totaling up to $450.0 million based on annual sales[77]. - The DFD-29 Agreement includes an upfront payment of $10.0 million and potential milestone payments totaling up to $158.0 million, with royalties ranging from 10% to 20% on net sales[78]. - The Qbrexza APA requires payments of up to $144.0 million upon achieving certain milestones, with royalties on sales ranging from mid-thirty to mid-twenty percent for the first two years[80]. - The Anti-itch Product Agreement involved a total consideration of $4.0 million, with an upfront payment of $2.0 million, and the product is expected to launch in the second half of 2024 or first half of 2025[86]. - The Ximino APA included total consideration of $9.4 million, with an upfront payment of $2.4 million and remaining payments due on anniversaries[88]. - The Exelderm APA had total consideration of $1.6 million, with an upfront payment of $1.2 million and a milestone payment of $0.4 million upon reaching a sales threshold[89]. Clinical Trials and Regulatory Approvals - Positive topline data from two Phase 3 clinical trials for DFD-29 were announced, demonstrating statistical superiority over standard care and placebo, with an NDA submitted to the FDA[32]. - The company expects potential FDA approval for DFD-29 in the second half of 2024, with a Prescription Drug User Fee Act goal date set for November 4, 2024[32]. - The NDA for DFD-29 was filed in January 2024 and is under review by the FDA[61]. - The company is conducting Phase 2 studies on a larger patient population to assess product efficacy, dose tolerance, and safety data[120]. - Phase 3 studies are aimed at establishing safety and efficacy in an expanded patient population[121]. - The FDA may require Phase 4 post-marketing studies to evaluate long-term risks and benefits of the drug[122]. - The FDA's special protocol assessment (SPA) process provides guidance on clinical trial design, but final marketing approval depends on Phase 3 trial results[124]. - The company must demonstrate product safety and efficacy through an NDA submission, which may require additional information even after acceptance[125]. - Section 505(b)(2) NDAs allow for alternate paths to FDA approval, relying on existing clinical data from previously approved products[126]. - The FDA may request a Risk Evaluation and Mitigation Strategy (REMS) as part of the approval process to ensure safe drug use[128]. - Clinical trial completion times can vary significantly, with potential delays due to patient enrollment, site personnel, and adverse events[123]. - Regulatory approval processes for product candidates are time-consuming and expensive, with potential delays affecting commercialization[163]. - The company is responsible for ensuring compliance with good clinical practices (GCPs) and good laboratory practices (GLP) in all clinical trials, with non-compliance potentially leading to unreliable clinical data[219]. Market Opportunities and Product Demand - The PAH market had approximately 450,000 prescriptions in 2023, indicating a significant market opportunity for Qbrexza®[39]. - The oral isotretinoin market had over 2 million prescriptions in 2023, highlighting the demand for Accutane® in treating severe acne[44]. - The oral doxycycline market had more than 27 million prescriptions in 2023, showcasing the potential for Targadox® as an adjunctive therapy for severe acne[46]. - The topical acne market had almost 21 million prescriptions in 2023, presenting unmet needs that Amzeeq® aims to address[48]. - The topical antifungal market had over 11 million prescriptions in 2023[54]. - The rosacea market had 3.8 million prescriptions in 2023[58]. Intellectual Property and Patent Protection - Three marketed products, Qbrexza, Amzeeq, and Zilxi, currently have patent protection[94]. - The company holds 22 issued U.S. patents and 41 issued foreign patents related to Qbrexza, with expiration dates ranging from 2028 to 2033 for issued patents and 2028 to 2034 for pending applications[96]. - For Amzeeq, there are 21 issued U.S. patents and 15 issued foreign patents, expiring between 2030 and 2037, with 6 pending U.S. applications and 1 pending foreign application[97]. - Zilxi has 14 issued U.S. patents and 15 issued foreign patents, also expiring between 2030 and 2037, with 4 pending U.S. applications and 1 pending foreign application[97]. - The company has an exclusive license for DFD-29, which includes 3 issued U.S. patents and 1 issued foreign patent, with expiration in 2039[97]. - The company emphasizes the importance of maintaining patent protection to safeguard its proprietary technologies and competitive position[100]. - The company has 39 issued U.S. patents and 20 issued foreign patents related to its molecular stabilizing technology platform, with 9 pending U.S. applications[97]. Manufacturing and Supply Chain Risks - The company relies on contract manufacturers for production, with no internal manufacturing capabilities, and faces risks associated with third-party manufacturing[113]. - If contract manufacturers fail to meet production requirements, the company may face delays in commercialization and potential revenue loss[170]. - Contract manufacturers must comply with federal, state, and foreign regulations, including cGMP requirements, to avoid manufacturing non-compliance and potential fines[171]. - Failure of contract manufacturers to deliver required commercial quantities on time could result in unmet product demand and lost revenues[172]. - The company relies on third parties for marketing approvals, which may introduce additional risks and complications[160]. - The company does not expect to have the resources to manufacture future approved products independently, remaining dependent on third-party manufacturers[214]. - The company relies on third-party manufacturers for raw materials necessary for production, with potential delays impacting clinical trials and regulatory approvals[216]. - The company may incur substantial liabilities from product liability claims, which could adversely affect its financial condition and stock price[223]. Regulatory and Compliance Challenges - The regulatory approval process for new drugs is lengthy and expensive, requiring extensive pre-clinical and clinical data submission to the FDA[117]. - The company faces significant uncertainty regarding third-party payor coverage and reimbursement for newly approved products[131]. - The majority of the company's operating income is expected to come from dermatology product sales, with potential setbacks from supply chain, demand, and competition impacting revenue[151]. - Generic versions of products are generally significantly less expensive, leading to intense price competition once market exclusivity is lost[156]. - Disruptions to the field sales force could significantly impact existing revenue streams and future product marketing capabilities[157]. - The company faces challenges from potential patent litigation and delays in the approval of new products under Section 505(b)(2) of the FDCA[168]. - Regulatory scrutiny continues post-approval, with potential consequences for non-compliance including unfavorable labeling and product withdrawal[176]. - The FDA may impose costly post-marketing studies or clinical trials to monitor product safety and efficacy[177]. - Legislative changes, such as the ACA, have increased Medicaid rebates from 15.1% to 23.1%, impacting profitability[190]. - The company faces risks from potential violations of healthcare laws, which could lead to significant civil and criminal penalties[188]. - Ongoing changes in healthcare regulations may adversely affect the ability to market products and raise capital[190]. - The American Rescue Plan Act of 2021 will eliminate the statutory cap on rebates drug manufacturers pay to Medicaid starting January 2024, potentially increasing costs for manufacturers[192]. - The Inflation Reduction Act of 2022 introduces a drug price negotiation program, requiring manufacturers to charge a negotiated "maximum fair price" for certain drugs or face excise taxes for noncompliance, which could adversely affect profitability[192]. - Future healthcare reforms may impose stricter coverage criteria and downward pressure on prices, impacting revenue generation and profitability[194]. - Increased scrutiny on drug safety may lead to delays in regulatory approvals and additional requirements for clinical trials, affecting the commercialization of future product candidates[195]. Management and Operational Insights - The company has made significant investments in building its commercial product portfolio, positioning itself for future growth[30]. - The company is a majority-owned subsidiary of Fortress, indicating strong backing for its strategic initiatives[29]. - The management team has over 135 years of collective sales and marketing experience in the pharmaceutical industry[66]. - The company covers over 80% of dermatologists in the top 50 U.S. metropolitan statistical areas[66]. - The company has a specialized access and distribution network of over 600 specialty pharmacies and wholesalers[66]. - The company is in various stages of discussion for new business development opportunities[64].

Journey Medical Corporation (NASDAQ:DERM) Q4 2023 Earnings Conference Call March 21, 2024 4:30 PM ET Company Participants Jaclyn Jaffe - Senior Director, Corporate Operations Claude Maraoui - Co-Founder, President and CEO Joseph Benesch - Interim Chief Financial Officer Dr. Srinivas Sidgiddi - Vice President, Research and Development Ramsey Allous - General Counsel and Corporate Secretary Conference Call Participants Scott Henry - Alliance Global Partners Operator Good afternoon ladies and gentlemen, and t ...

Financial Data and Key Metrics Changes - The company reported total revenue of $79.2 million for 2023, a 7% increase from $73.7 million in 2022, marking an all-time high since inception [18][37] - Gross profit margins increased by 22% in 2023 due to a 50% reduction in contractual royalty obligations for Qbrexza starting in May 2023 [38] - SG&A expenses decreased by $15.6 million or 26% to $43.9 million in 2023 compared to $59.5 million in 2022 [39] - The net loss for 2023 was $3.9 million or $0.21 per share, significantly improved from a net loss of $29.6 million or $1.69 per share in 2022 [41] Business Line Data and Key Metrics Changes - Accutane experienced a 27% year-over-year growth in IMS prescriptions from 2022 to 2023 [1] - Qbrexza saw a 6% increase in prescription levels from 2022 to 2023, indicating effective marketing and sales efforts [2] - The four core products (Qbrexza, Accutane, Amzeeq, and Zilxi) now represent approximately 90% of the company's product revenue [20] Market Data and Key Metrics Changes - DFD-29, a new oral therapy for rosacea, demonstrated statistical superiority in clinical trials compared to the current market leader, Oracea, which had approximately $300 million in annual TRx sales in 2023 [22][29] - DFD-29 is expected to achieve peak annual net sales of $300 million, with $200 million projected from the U.S. market alone [30] Company Strategy and Development Direction - The company aims to continue reducing SG&A expenses by an additional $2 million to $5 million in 2024, targeting a total reduction of approximately $20 million from the 2022 SG&A expense base [20] - The company is focused on out-licensing its intellectual property and exploring new product opportunities in dermatology to enhance revenue [27][34] - The company plans to invest resources for the NDA approval and commercial launch of DFD-29 in early 2025 [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the market potential for DFD-29 and its ability to differentiate itself in the rosacea treatment landscape [24] - The company is well-positioned to invest in and prepare for the anticipated launch of DFD-29, believing it could become the standard of care for rosacea treatment [33] - Management highlighted the importance of stabilizing the commercial business and the positive contributions expected from core brands [21] Other Important Information - The company paid off a $20 million debt facility and entered a new credit agreement with SWK Holdings for up to $20 million in non-dilutive debt capital [26] - The company had $27.4 million in cash and cash equivalents at the end of 2023, down from $32 million at the end of 2022 [42] Q&A Session Summary Question: Can you discuss the rights for DFD-29 outside the U.S. and potential timelines for international market entry? - The company holds global rights for DFD-29 except for BRIC and CIS countries, with a focus on the U.S. market while exploring potential partnerships in Europe and Asia [50] Question: What are the expected incremental launch costs for DFD-29 in 2025? - The company plans to expand its sales force from 35 to potentially 45-50 representatives as they prepare for the launch, which is anticipated in Q1 or early Q2 of 2025 [53][55]

Revenue Performance - Total revenues for Journey Medical Corporation reached $79.2 million in 2023, a 7% increase from $73.7 million in 2022, primarily driven by a $19.0 million revenue from a licensing agreement with Maruho[1][3] - Total revenue for 2023 was $79,181,000, an increase of 7% compared to $73,669,000 in 2022[16] - Product revenue decreased to $59,662,000 in 2023 from $70,995,000 in 2022, representing a decline of 16%[16] - Other revenue significantly increased to $19,519,000 in 2023 from $2,674,000 in 2022, marking a growth of 629%[16] Cost Management - Operating cost savings of $15.6 million were achieved in 2023, exceeding the initial guidance of $12.0 million[1][5] - Total operating expenses decreased to $81,254,000 in 2023 from $101,186,000 in 2022, a reduction of 20%[16] - Research and development costs decreased to $7.5 million in 2023 from $10.9 million in 2022, attributed to lower clinical trial expenses for DFD-29[5] Financial Performance - The net loss for 2023 was $(3.9) million, or $(0.21) per share, significantly improved from a net loss of $(29.6) million, or $(1.69) per share in 2022[5] - Net loss for 2023 was $3,853,000, a significant improvement compared to a net loss of $29,628,000 in 2022[16] - Adjusted EBITDA for 2023 was $15.6 million, or $0.85 per share basic, compared to an Adjusted EBITDA of $(7.3) million in 2022[5] - Adjusted EBITDA for 2023 was $15,587,000, compared to a negative $7,283,000 in 2022, indicating a turnaround in operational performance[22] - Basic net loss per common share improved to $0.21 in 2023 from $1.69 in 2022[22] Assets and Liabilities - Total assets decreased to $76,849,000 in 2023 from $105,160,000 in 2022, a decline of 27%[14] - Total liabilities reduced to $56,499,000 in 2023 from $88,178,000 in 2022, a decrease of 36%[14] - Stockholders' equity increased to $20,350,000 in 2023 from $16,982,000 in 2022, reflecting a growth of 20%[14] Strategic Initiatives - The FDA accepted the New Drug Application for DFD-29 with a PDUFA goal date of November 4, 2024, which could position it as a leading treatment for rosacea[1][10] - Journey Medical entered into a $20.0 million credit facility with SWK Holdings Corporation to support general corporate purposes, including the potential launch of DFD-29[5] - The company expanded its market presence in Asia through a licensing agreement with Maruho, enhancing the reach of Qbrexza®[2][5]

Company generated total revenues of $79.2 million for the full year ended December 31, 2023, a 7% increase from the $73.7 million reported in 2022 Achieved $15.6 million in operating cost savings in 2023, ahead of initial guidance of $12.0 million New Drug Application for rosacea treatment candidate DFD-29 accepted for U.S. FDA review; PDUFA goal date of November 4, 2024 Company to hold conference call today at 4:30 p.m. ET to discuss the financial results and provide a business update SCOTTSDALE, Ariz., M ...