Journey Medical (DERM)

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Journey Medical (DERM) - 2024 Q4 - Earnings Call Transcript
2025-03-26 21:32
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 [7][18] - Total net product revenue for 2024 was $55.1 million, down from $59.7 million in 2023 [18] - The net loss for common shareholders was $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 [21] - 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 [22] 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 the IMROCI NDA filing [19] - Selling, general and administrative expenses decreased by $3.7 million to $40.2 million in 2024, reflecting expense optimization efforts [20] Market Data and Key Metrics Changes - As of early 2025, Journey Medical achieved approximately 20% commercial payer coverage for IMROCI, up from 12% at the time of FDA approval [13] - The company anticipates significant increases in payer coverage throughout 2025 and into 2026 [13] Company Strategy and Development Direction - The launch of IMROCI is positioned as a transformational opportunity for Journey Medical, with potential peak annual sales estimated at $200 million in the U.S. and $100 million internationally [24] - The company plans to focus on driving value for patients and shareholders while preparing for a robust launch of IMROCI [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early progress of IMROCI and the potential for significant operating leverage as the product gains market traction [10][14] - The company is optimistic about the impact of upcoming peer-reviewed publications and medical conference presentations on IMROCI's market awareness [25] Other Important Information - Journey Medical paid $22 million in FDA filing fees and milestone payments related to IMROCI in 2024, completing its financial obligations for the product's regulatory fees [9] - The company had $20.3 million in cash as of December 31, 2024, down from $27.4 million at the end of 2023 [22] 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 post-launch, with ongoing efforts to increase coverage [28][30] Question: Importance of erythema data from KOL interactions - The head-to-head performance data was of significant interest to physicians, overshadowing the erythema data [32][34] Question: Thoughts on 2025 guidance - Management plans to provide 2025 financial guidance later in the year after assessing initial prescription demand [41][42] Question: Reimbursement environment in early days - Initial coverage is around 20%, which aligns with expectations, but it is too early to provide a comprehensive assessment [44][45] Question: Revenue expectations for Q1 - Modest revenue is expected in Q1, with meaningful revenue anticipated starting in Q2 [46] Question: Performance of legacy products - Legacy products have shown consistent performance, with QBREXZA continuing to grow, while Accutane has stabilized after facing new competition [50][51] Question: Pricing across the portfolio - Pricing for legacy brands is expected to remain steady, with improved margins for certain products due to the cessation of royalty payments [61][62] Question: International licensing opportunities for IMROCI - The company is exploring out-licensing opportunities for IMROCI in international markets while focusing on the U.S. launch [68]
Journey Medical (DERM) - 2024 Q4 - Earnings Call Transcript
2025-03-26 20:30
Financial Data and Key Metrics Changes - Journey Medical reported annual revenue of $56 million for 2024, a decrease from $79 million in 2023, primarily due to higher rebate costs and lower unit volumes from legacy products [7][18] - Total net product revenue for 2024 was $55.1 million, down from $59.7 million in 2023 [18] - 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 [21] - Non-GAAP adjusted EBITDA for 2024 was positive $800,000, down from $15.6 million in 2023 [22] 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 the IMROCI NDA filing [19] - Selling, general and administrative expenses decreased by $3.7 million to $40.2 million in 2024, attributed to expense optimization efforts [20] Market Data and Key Metrics Changes - As of early 2025, Journey Medical achieved approximately 20% commercial payer coverage for IMROCI, up from 12% at the time of FDA approval [13] - The company anticipates significant increases in payer coverage throughout 2025 and into 2026 [13] Company Strategy and Development Direction - The launch of IMROCI is positioned as a transformational opportunity for Journey Medical, with potential peak annual sales estimated at $200 million in the U.S. and $100 million internationally [24][25] - The company plans to focus on driving value for patients and shareholders while preparing for additional publications and medical congress presentations throughout 2025 [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early progress of IMROCI's launch and the positive reception from dermatologists at the AAD Conference [11][12] - The company is focused on achieving sustainable positive EBITDA and profitability while exploring potential licensing opportunities for international markets [25] Other Important Information - Journey Medical paid $22 million in FDA filing fees and milestone payments related to IMROCI in 2024, completing its financial obligations for the product's regulatory fees [9] - The company had $20.3 million in cash as of December 31, 2024, down from $27.4 million at the end of 2023 [22] 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 coverage based on demand [28][30] Question: Importance of erythema data from KOL interactions - The head-to-head performance data was more significant to providers than erythema data, which will be disseminated through the JAMA publication [32][35] Question: Thoughts on 2025 guidance - Management plans to provide 2025 financial guidance later in the year after assessing initial prescription demand [41][42] Question: Reimbursement environment in early days - The reimbursement environment is currently on target, with approximately 20% adoption on formularies [44][46] Question: Revenue expectations for Q1 - Minimal revenue is expected in Q1, with meaningful revenue anticipated starting in Q2 [47] Question: Base business performance in Q4 - The base business has been steady, with legacy brands continuing to erode but core products performing consistently [48][50] Question: Pricing across the legacy portfolio in 2025 - Pricing for legacy brands is expected to remain steady, with some erosion in volume due to competition [62] Question: Milestones for IMROCI launch - Key focus areas include supply and formulary coverage, with management optimistic about progress [66][68] Question: International licensing opportunities for IMROCI - The company is looking to out-license IMROCI internationally while focusing on the U.S. market [70]
Journey Medical (DERM) - 2024 Q4 - Annual Results
2025-03-26 20:06
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].
Journey Medical Corporation Reports Full-Year 2024 Financial Results and Recent Corporate Highlights
Globenewswire· 2025-03-26 20:01
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]
Journey Medical Corporation Launches Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) for the Treatment of Rosacea
Globenewswire· 2025-03-24 12:30
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]
Journey Medical Corporation to Announce Year End 2024 Financial Results on March 26, 2025
GlobeNewswire News Room· 2025-03-19 20:01
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]
Journey Medical Corporation to Participate in the 37th Annual ROTH Conference
Globenewswire· 2025-03-12 12:30
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 seven branded and two generic products aimed at treating common skin conditions [3] - Journey Medical was founded by Fortress Biotech, Inc. and is located in Scottsdale, Arizona [3] Upcoming Events - Management will participate in the 37th Annual ROTH Conference from March 16-18, 2025, in Dana Point, California [1] - Claude Maraoui, President and CEO, will engage in a fireside chat on March 18 at 12:30 p.m. PT and will be available for one-on-one meetings during the conference [2] - A webcast of the fireside chat will be accessible on the company's website for approximately 30 days post-event [2]
Journey Medical Corporation Announces Publication in the Journal of the American Medical Association - Dermatology of the Phase 3 Clinical Trial Results of Emrosi™ (DFD-29) to Treat Rosacea
Newsfilter· 2025-03-05 21:01
Core Insights - Emrosi™ (DFD-29) received FDA approval for treating inflammatory lesions of rosacea in adults in November 2024, with a launch expected in early spring 2025 [2][3] - The results from two Phase 3 clinical trials (MVOR-1 and MVOR-2) demonstrated the efficacy and safety of DFD-29, showing statistical superiority over Oracea® (doxycycline) and placebo [1][3] Company Overview - Journey Medical Corporation is a commercial-stage pharmaceutical company focused on marketing FDA-approved prescription products for dermatological conditions [11] - The company is based in Scottsdale, Arizona, and was founded by Fortress Biotech, Inc. [11] Clinical Trial Results - In MVOR-1, 65.0% of subjects in the DFD-29 group achieved IGA success compared to 46.1% in the Oracea group and 31.2% in the placebo group, with significant p-values of 0.01 and <0.001 respectively [4][6] - In MVOR-2, 60.1% of subjects in the DFD-29 group achieved IGA success compared to 31.4% in the Oracea group and 26.8% in the placebo group, with significant p-values of <0.001 for both comparisons [5][6] - DFD-29 showed a mean reduction of 21.3 lesions in MVOR-1 and 18.0 lesions in MVOR-2, both statistically significant compared to Oracea and placebo [4][5][6] Safety Profile - No major safety issues or serious adverse events were reported in both clinical trials, with treatment-emergent adverse events being similar across groups [3][4][5] Market Potential - Rosacea affects over 16 million Americans and approximately 415 million people worldwide, indicating a significant market opportunity for Emrosi™ [9][10]
Journey Medical Corporation to Exhibit at the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida
Globenewswire· 2025-03-04 21:01
Core Viewpoint - Journey Medical Corporation has received FDA approval for Emrosi™, a treatment for inflammatory lesions of rosacea in adults, and plans to showcase this product at the upcoming AAD Annual Meeting in March 2025 [1][2][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 seven branded and two generic products aimed at treating common skin conditions [7]. - Founded by Fortress Biotech, Inc., Journey Medical is headquartered in Scottsdale, Arizona [7]. Product Information - Emrosi™ is a modified-release formulation of Minocycline Hydrochloride, consisting of 10 mg immediate release and 30 mg extended release, and is the lowest-dose oral minocycline available [1][3]. - The product is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults [4]. - Clinical outcomes for Emrosi™ are reported to be significantly superior compared to placebo and Oracea®, while maintaining a comparable safety profile [3]. Industry Context - Rosacea affects over 16 million Americans and approximately 415 million people worldwide, primarily adults aged 30 to 50 [6]. - The condition can severely impact patients' self-esteem and social interactions, with many reporting adverse effects on their professional lives [6]. Event Participation - Journey Medical will exhibit at the 2025 AAD Annual Meeting, which is a significant event in the dermatology field, featuring over 350 exhibitors and nearly 20,000 attendees [3].
Journey Medical Corporation: Emrosi's Launch Could Be A Turning Point
Seeking Alpha· 2025-01-30 14:18
Core Insights - The article emphasizes the importance of recognizing intangible assets in investment analysis, particularly in the context of technological advancements and their impact on market dynamics [2]. Group 1: Investment Philosophy - The investment approach focuses on identifying hidden value and potential in intangible assets, especially through R&D efforts [2]. - The author believes that the current technological revolution, particularly in hardware, is significant and compares it to the commercialization of the Internet [2]. Group 2: Market Trends - The article suggests that there is no current AI bubble, indicating a stable environment for investment in technology [2]. - NVIDIA is highlighted as a central player in the ongoing hardware revolution, which is expected to drive future growth [2]. Group 3: Historical Context - The author references historical technological revolutions funded by visionary investors, which have led to increased prosperity [2]. - The influence of Baruch Lev's work on the recognition of intangible assets and George Soros's insights on market bubbles is noted as shaping the author's investment perspective [2].