Journey Medical (DERM)

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Journey Medical (DERM) - 2023 Q3 - Earnings Call Transcript
2023-11-12 05:34
Journey Medical Corporation (NASDAQ:DERM) Q3 2023 Earnings Conference Call November 7, 2023 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 - ROTH Capital Andy Fleszar - B. Riley Operator Ladies and gentlemen, thank y ...
Journey Medical (DERM) - 2023 Q2 - Earnings Call Transcript
2023-08-12 14:15
Financial Data and Key Metrics Changes - Total net revenues for Q2 2023 were $17.2 million, a 41% increase from $12.2 million in Q1 2023, but a slight decrease of $1.1 million from the prior year quarter [41][44] - GAAP net loss for Q2 2023 was $8.4 million or $0.46 per share, compared to a loss of $10.1 million or $0.57 per share in Q1 2023 [55] - Non-GAAP adjusted EBITDA for Q2 2023 resulted in a net loss of $600,000 or $0.04 per share, an improvement from a loss of $5.3 million in Q1 2023 [56] Business Line Data and Key Metrics Changes - Qbrexza led with net sales of $8 million in Q2, a 97% increase from $4 million in Q1 2023, achieving a new quarterly all-time high [39] - Accutane had net sales of $5.5 million in Q2, up 20% from $4.6 million in Q1 2023 [39] - Combined revenue from core products Qbrexza, Accutane, Amzeeq, and Zilxi accounted for approximately 92% or $15.6 million of total product revenues in Q2 2023 [48] Market Data and Key Metrics Changes - Approximately 4 million prescriptions were written for rosacea in 2022, indicating a significant market opportunity for DFD-29 [29] - The rosacea market is predominantly topical, with about 90% of prescriptions being topical and only 10% oral [3][2] Company Strategy and Development Direction - The company plans to submit a New Drug Application for DFD-29 in the second half of 2023, with peak sales potential estimated at $300 million globally [22] - DFD-29 is positioned to become the new treatment paradigm for rosacea, leveraging its safety profile and efficacy compared to existing treatments [42] - The company aims to achieve operational profitability by the end of 2023, supported by reduced SG&A expenses and improved revenue from core products [54][47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive non-GAAP adjusted EBITDA for fiscal year 2023, driven by revenue growth and expense management [44][56] - The successful Phase 3 trials for DFD-29 were highlighted as a transformational event for the company, with expectations for significant market share capture upon launch [30][22] Other Important Information - The company has paid off its entire debt facility with East West Bank, resulting in zero bank debt [40] - R&D expenses decreased by 32% year-over-year due to lower clinical trial expenses for DFD-29 [51] Q&A Session Summary Question: How comfortable is the company with its cash balance? - The company indicated it has sufficient cash to support operations and does not plan to raise equity funding, focusing instead on potential debt facilities [70] Question: What is the expected trajectory for DFD-29's peak sales? - Management expects a ramp-up to peak sales within two to three years post-launch, contingent on FDA approval [66] Question: How reflective were the trial patients of the real-world population? - The inclusion criteria for the trials were designed to reflect the typical rosacea patients seen in clinical practice, ensuring relevance to real-world prescribing [79] Question: What proportion of rosacea patients would be prescribed DFD-29 if approved? - The response indicated a strong likelihood of adoption among dermatologists, with some early adopters likely to prescribe it widely [88]
Journey Medical (DERM) - 2023 Q2 - Quarterly Report
2023-08-09 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-41063 JOURNEY MEDICAL CORPORATION (Exact name of registrant as specified in its charter) ( ...
Journey Medical (DERM) - 2023 Q1 - Earnings Call Transcript
2023-05-22 22:50
Journey Medical Corp (NASDAQ:DERM) Q1 2023 Earnings Conference Call May 22, 2023 4:30 PM ET Company Participants Matt Blazei - CORE IR Claude Maraoui - Founder, President and CEO Joseph Benesch - Interim CFO Conference Call Participants Operator Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Journey Medical's First Quarter 2023 Financial Results and Corporate Update Conference Call. At this time, all participants are in listen-only mode. [Operator Instructions] Participan ...
Journey Medical (DERM) - 2023 Q1 - Quarterly Report
2023-05-21 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-41063 JOURNEY MEDICAL CORPORATION (Exact name of registrant as specified in its charter) ...
Journey Medical (DERM) - 2022 Q4 - Annual Report
2023-03-30 16:00
Product Portfolio and Market Opportunities - The company has a portfolio of eight branded and three authorized generic prescription drugs for dermatological conditions marketed in the U.S.[28] - The U.S. market size for acne treatment is estimated at approximately $3 billion annually[46] - The oral isotretinoin market had over 2 million prescriptions in 2022, indicating strong demand for Accutane®[48] - The oral doxycycline market had more than 25 million prescriptions in 2022, highlighting the popularity of Targadox®[50] - The topical acne market had almost 20 million prescriptions in 2022, showcasing significant unmet needs that Amzeeq® aims to address[53] - The oral minocycline market had just under 3 million prescriptions in 2022, reflecting the demand for Ximino®[55] - The topical antifungal market had more than 11 million prescriptions in 2022, indicating a robust market for Exelderm®[59] - The rosacea market had 3.6 million prescriptions in 2022, demonstrating a substantial opportunity for Zilxi® and DFD-29[64] Financial Information and Capital Management - As of December 31, 2022, the company has $150.0 million available under its shelf registration statement for the offering of common stock, preferred stock, debt securities, and warrants[29] - The company has a revolving line of credit of $10.0 million, with $2.9 million outstanding as of December 31, 2022[36] - The company received a net milestone payment of $2.5 million from Maruho for the approval of Rapifort® Wipes 2.5% in Japan, reflecting a total year-to-date royalty of $0.2 million[31] - An upfront payment of $20 million was made for the acquisition of VYNE's Molecule Stabilizing Technology™ franchise, with additional contingent payments based on sales milestones totaling up to $450 million[83] - The DFD-29 Agreement includes an upfront payment of $10 million and potential milestone payments totaling up to $158 million, with royalties ranging from 10% to 20% on net sales[85] - The Qbrexza APA involved an upfront payment of $12.5 million, with potential milestone payments of up to $144 million and royalties on sales ranging from mid-thirty to mid-twenty percent[87] - The Accutane Agreement includes an upfront payment of $1 million and additional milestone payments totaling $17 million, with royalties in the low-double digits based on net sales[93] - The Anti-itch APA has a total consideration of $4 million, with an upfront payment of $2 million, and the product is expected to launch in the second half of 2023[95] Clinical Trials and Product Development - The Phase 3 clinical trial for DFD-29 (Minocycline Modified Release Capsules 40 mg) for Rosacea treatment achieved 100% enrollment in January 2023, with top-line data expected in Q2 2023[30] - DFD-29 demonstrated a 66.04% IGA treatment success rate compared to 33.33% for Oraycea, and a reduction of 19.2 inflammatory lesions compared to 10.5 for Oraycea[30] - The company obtained global rights for DFD-29 on June 29, 2021, and plans to submit the NDA in the second half of 2023, with FDA approval anticipated in the second half of 2024[102][103] - In Phase 2 trials, DFD-29 demonstrated a 66.04% IGA treatment success rate compared to 33.33% for Oraycea, and a reduction of 19.2 inflammatory lesions compared to 10.5 for Oraycea[103][104] Regulatory and Compliance Challenges - The FDA imposes substantial regulations on clinical development and marketing, requiring rigorous pre-clinical testing and clinical trials[128] - The regulatory approval process is lengthy and expensive, potentially taking many years and requiring significant resources[129] - The company is subject to various federal, state, and local laws, including the Anti-Kickback Statute, which could lead to significant penalties for non-compliance[151] - The Drug Quality and Security Act (DQSA) requires compliance with regulations aimed at enhancing drug supply chain security, with full traceability requirements effective by November 27, 2023[157] - The marketing approval process for new products is lengthy and costly, with potential delays impacting commercialization[173] - The company relies on third parties for regulatory approval processes, which may pose risks if not managed effectively[171] - The establishment and maintenance of a field sales force are critical for commercial success, with disruptions potentially leading to adverse revenue impacts[168] - Regulatory authorities have substantial discretion in the approval process, which may lead to delays or rejection of applications, impacting future commercial prospects and revenue generation[174] Competitive Landscape - The dermatology competitive landscape is highly fragmented, with numerous midsize and smaller companies competing in both the prescription and OTC sectors[120] - Major competitors include Galderma Laboratories, Almirall, and Verrica Pharmaceuticals, among others, varying by therapeutic and product category[122] - Increased competition from generic pharmaceutical manufacturers is anticipated, particularly as patents expire or are challenged[123] - The majority of sales derive from products without patent protection, exposing the company to generic competition and potential revenue declines[164] - Four marketed products currently have patent protection, while three do not, increasing vulnerability to generic competition[166] Operational and Supply Chain Risks - The company relies on multiple contract manufacturers for production, with no internal manufacturing capabilities, which poses risks related to compliance and supply[125] - The company is heavily dependent on third-party suppliers for raw materials, manufacturing, and services, which poses risks to its business and financial condition[218] - Any interruption from third-party manufacturers could lead to increased costs and delays in product development and commercialization[219] - Compliance with FDA regulations is critical, and any failure by contract manufacturers could result in significant penalties and impact product availability[220] - The company lacks control over the acquisition of raw materials by third-party manufacturers, which could delay clinical trials and regulatory approvals[221] Strategic Initiatives and Future Outlook - The company plans to launch its Anti-itch Product in the second half of 2023, expanding its product portfolio[63] - The company is in various stages of discussion for new business development opportunities, which could drive additional growth[69] - The company aims to enhance its product line through strategic alliances and collaborations, sharing risks associated with research and development expenses[73] - The company is focused on cost management and efficient capital allocation, leveraging expertise from over 30 Fortress employees in various fields[75] - Future revenue from dermatology products is expected to be the primary source of operating income, with potential setbacks from supply chain, demand, and regulatory issues[163]
Journey Medical (DERM) - 2022 Q4 - Earnings Call Transcript
2023-03-30 02:13
Journey Medical Corp (NASDAQ:DERM) Q4 2022 Earnings Conference Call March 29, 2023 4:30 PM ET Company Participants Matt Blazei - CORE IR Claude Maraoui - Founder, President, CEO & Director Joseph Benesch - Interim CFO Srinivas Sidgiddi - VP, Clinical Development & Medical Affairs Conference Call Participants Brandon Folkes - Cantor Fitzgerald Scott Henry - ROTH MKM Partners Andrew Fleszar - B. Riley Securities Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the Jour ...
Journey Medical (DERM) - 2022 Q3 - Earnings Call Transcript
2022-11-12 14:50
Journey Medical Corporation (NASDAQ:DERM) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Matt Blazei – CORE IR Claude Maraoui – Co-Founder, President and Chief Executive Officer Ernie De Paolantonio – Chief Financial Officer Ramsey Alloush – General Counsel Conference Call Participants Scott Henry – ROTH Capital Brandon Folkes – Cantor Fitzgerald Operator Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to the Journey Medical’s Third Quarter 20 ...
Journey Medical (DERM) - 2022 Q3 - Quarterly Report
2022-11-09 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-41063 JOURNEY MEDICAL CORPORATION (Exact name of registrant as specified in its chart ...
Journey Medical (DERM) - 2022 Q2 - Earnings Call Transcript
2022-08-10 12:06
Journey Medical Corporation (NASDAQ:DERM) Q2 2022 Results Conference Call August 9, 2022 4:30 PM ET Company Participants Claude Maraoui - Co-Founder President and Chief Executive Officer Ernest De Paolantonio - Chief Financial Officer Ramsey Alloush - General Counsel Dr. Srinivas Sidgiddi - Vice President of Clinical Development and Medical Affairs Jules Abraham - IR, CORE IR Conference Call Participants Brandon Folkes - Cantor Fitzgerald Mayank Mamtani - B. Riley FBR Operator Ladies and gentlemen, thank yo ...