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Journey Medical (DERM) - 2025 Q1 - Earnings Call Transcript
2025-05-14 21:30
Financial Data and Key Metrics Changes - Journey Medical reported net product sales of $13.1 million for Q1 2025, a slight increase from $13.0 million in Q1 2024, which included $2.0 million from the initial launch of AMROCI [5][11] - Gross margin improved to 64% in Q1 2025 from 54% in the prior year, attributed to lower product costs and a favorable sales mix [12] - Net loss for Q1 2025 was $4.1 million, or $0.18 per share, compared to a net loss of $10.4 million, or $0.53 per share, in Q1 2024 [13] Business Line Data and Key Metrics Changes - The launch of AMROCI is seen as a significant milestone, contributing positively to the overall sales performance [5] - The legacy business, which includes older brands facing generic competition, experienced a decline of approximately 10% to 15% [22] - QBREXZA showed strong performance with a 15% increase in prescriptions year-over-year for March and April 2025 [24] Market Data and Key Metrics Changes - Approximately 30% of covered commercial insured lives now have access to AMROCI, up from 20% previously [10] - The company actively calls on about 83% of dermatology offices that prescribe oral rosacea treatments, enhancing market penetration [8] Company Strategy and Development Direction - Journey Medical aims to expand access and grow prescription volume for AMROCI while publishing additional peer-reviewed data to support its clinical value [17] - The company is focused on building brand awareness and ensuring payer coverage to translate prescription momentum into sales [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive initial response to AMROCI and its potential to become the flagship product, contributing to sustainable EBITDA positivity later in the year [5] - The company views 2025 as a transformational year, with expectations for continued growth and market adoption of AMROCI [17] Other Important Information - The Phase III clinical trial results for AMROCI were published in JAMA Dermatology, highlighting its superiority over competitors [7] - The National Rosacea Society updated its treatment algorithms to include AMROCI, signaling confidence from the dermatology community [8] Q&A Session Summary Question: Expectations for AMROCI revenues in Q2 - Management indicated that the initial $2 million in revenue was primarily from stocking and expects additional revenues in Q2 as the product gains traction [19][20] Question: Performance of the legacy business - The legacy business is expected to continue facing challenges due to generic competition, with QBREXZA performing well despite new competition [22][23] Question: Inventory levels in the distribution channel - Management estimated that inventory levels are typically between two to four weeks during a new product launch [31][32] Question: Feedback from prescribers - Positive feedback has been received regarding AMROCI's efficacy, with many prescribers impressed by its clinical results [34][35] Question: Patient demographics for AMROCI - Initial prescriptions are primarily from new patients, with potential for switching from existing treatments as prescribers gain confidence [40][41] Question: Erythema reduction feedback - Anecdotal feedback indicates that some prescribers have noted significant erythema reduction, which may be incorporated into future messaging [46][50]
Journey Medical (DERM) - 2025 Q1 - Quarterly Results
2025-05-14 20:05
[Financial Results](index=1&type=section&id=Financial%20Results) Journey Medical reported stable Q1 2025 net product revenues, a 10 p.p. gross margin increase to 64%, and a reduced net loss of $4.1 million Q1 2025 vs Q1 2024 Financial Performance | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Total Net Product Revenues | $13.1 million | $13.0 million | +0.8% | | Gross Margin | 64% | 54% | +10 p.p. | | Research and Development | Nil | $7.9 million | -100% | | Selling, General & Administrative | $10.6 million | $8.4 million | +$2.2 million | | Net Loss | $(4.1) million | $(10.4) million | +$6.3 million | | Net Loss Per Share | $(0.18) | $(0.53) | +$0.35 | | Cash and Cash Equivalents (at end of period) | $21.1 million | N/A | N/A | - The launch of Emrosi contributed **$2.1 million** in incremental net product revenue in Q1 2025[4](index=4&type=chunk) - The increase in SG&A expenses was primarily due to incremental operational activities related to the launch and commercialization of Emrosi[10](index=10&type=chunk) [Recent Corporate Highlights](index=2&type=section&id=Recent%20Corporate%20Highlights) Q1 highlights include the strong commercial launch of Emrosi™, publication of its superior Phase 3 clinical trial results, and a new COO appointment - The commercial launch of Emrosi™ is off to a strong start, with initial prescriptions filled in late March 2025 and a full launch on April 7, 2025[1](index=1&type=chunk)[3](index=3&type=chunk)[10](index=10&type=chunk) - Emrosi's Phase 3 clinical trial results, published in JAMA Dermatology, demonstrated statistical superiority over both Oracea® and placebo for treating rosacea[1](index=1&type=chunk)[3](index=3&type=chunk)[10](index=10&type=chunk) - Emrosi™ was incorporated into the National Rosacea Society's updated Rosacea Treatment Algorithms, enhancing its credibility among prescribers[1](index=1&type=chunk)[3](index=3&type=chunk)[10](index=10&type=chunk) - In April 2025, Ramsey Alloush, previously General Counsel, was appointed as the company's Chief Operating Officer[10](index=10&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section details the unaudited consolidated balance sheets and statements of operations, outlining the company's financial position and performance [Unaudited Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets increased to $85.0 million, supported by higher cash and receivables, with total liabilities and equity also rising Consolidated Balance Sheet Highlights ($ in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $21,070 | $20,305 | | Total current assets | $53,986 | $48,179 | | Total assets | $84,962 | $80,241 | | Total current liabilities | $40,222 | $35,175 | | Total liabilities | $63,421 | $60,172 | | Total stockholders' equity | $21,541 | $20,069 | [Unaudited Consolidated Statements of Operations](index=5&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations) Q1 2025 net loss significantly improved to $4.1 million, or $(0.18) per share, driven by stable revenue and reduced R&D expenses Consolidated Statements of Operations Highlights ($ in thousands) | Account | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Product revenue, net | $13,139 | $13,030 | | Cost of goods sold | $4,790 | $6,002 | | Research and development | $39 | $7,884 | | Selling, general and administrative | $10,569 | $8,420 | | Loss from operations | $(3,324) | $(10,090) | | Net loss | $(4,073) | $(10,442) | | Net loss per share (Basic & Diluted) | $(0.18) | $(0.53) | [Non-GAAP Financial Measures](index=6&type=section&id=Use%20of%20Non-GAAP%20Measures) Non-GAAP Adjusted EBITDA is used to clarify core performance, showing a Q1 2025 loss of $0.9 million versus a positive $11,000 in Q1 2024 - Management uses non-GAAP measures like Adjusted EBITDA to provide transparency on core performance by excluding non-cash and infrequent items such as share-based compensation, amortization, and short-term R&D expenses related to the Emrosi pre-approval phase[18](index=18&type=chunk)[20](index=20&type=chunk)[21](index=21&type=chunk) Reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA ($ in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **GAAP Net Loss** | **$(4,073)** | **$(10,442)** | | Interest | $742 | $331 | | Amortization of acquired intangible assets | $1,065 | $814 | | **EBITDA** | **$(2,266)** | **$(9,297)** | | Share-based compensation | $1,323 | $1,406 | | Short-term R&D | $39 | $7,740 | | Other (Foreign exchange, Severance) | $7 | $162 | | **Non-GAAP Adjusted EBITDA** | **$(897)** | **$11** | - Non-GAAP Adjusted EBITDA was a loss of **$0.9 million**, or **$(0.04) per share**, for Q1 2025, compared to income of **$11,000**, or **$0.00 per share**, for Q1 2024[23](index=23&type=chunk)
Journey Medical Corporation Reports First Quarter 2025 Financial Results and Recent Corporate Highlights
GlobeNewswire News Room· 2025-05-14 20:01
Revenue for the First Quarter Ended March 31, 2025 was $13.1 million Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) Commercial Launch Off to a Strong Start, Initial Prescriptions Filled in Late March 2025 Phase 3 Clinical Trial Results for Emrosi Published in JAMA Dermatology Emrosi Now Included in Updated National Rosacea Society Treatment Algorithms Company to Hold Conference Call Today at 4:30 p.m. ET SCOTTSDALE, Ariz., May 14, 2025 (GLOBE NEWSWIRE) -- Journey Medical Corporation ( ...
Journey Medical Corporation to Announce First Quarter 2025 Financial Results on May 14, 2025
Globenewswire· 2025-05-07 20:01
Core Insights - Journey Medical Corporation will release its first quarter 2025 financial results on May 14, 2025, after U.S. financial markets close [1] - A conference call and audio webcast will be held on the same day at 4:30 p.m. ET to discuss the financial results and provide a corporate update [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 currently markets eight FDA-approved prescription drugs and has a team of industry experts with extensive experience in dermatology [4] - Journey Medical is based in Scottsdale, Arizona, and was founded by Fortress Biotech, Inc. [4]
Journey Medical (DERM) Moves 16.8% Higher: Will This Strength Last?
ZACKS· 2025-04-23 12:00
While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical research shows a strong correlation between trends in earnings estimate revisions and near-term stock price movements. For Journey Medical, the consensus EPS estimate for the quarter has been revised 1100% lower over the last 30 days to the current level. And a negative trend in earnings estimate revisions doesn't usually translate into price appreciation. So, make sure to keep an eye on D ...
Journey Medical (DERM) Surges 9.1%: Is This an Indication of Further Gains?
ZACKS· 2025-04-07 14:46
Company Overview - Journey Medical Corporation (DERM) shares increased by 9.1% to $7.19 in the last trading session, with a notable trading volume, contributing to a 30.2% gain over the past four weeks [1] - The rise in stock price is linked to positive investor sentiment regarding the growing sales of its branded and generic dermatological drugs [1] Financial Expectations - The company is projected to report a quarterly loss of $0.24 per share, reflecting a year-over-year change of +54.7% [2] - Expected revenues are $11.89 million, which is an 8.8% decline from the same quarter last year [2] Earnings Estimate Revisions - The consensus EPS estimate for Journey Medical has been revised down by 1100% over the last 30 days [3] - A negative trend in earnings estimate revisions typically does not lead to stock price appreciation, indicating potential caution for future performance [3] Industry Context - Journey Medical is part of the Zacks Medical - Drugs industry, where Assertio (ASRT) has seen a decline of 15.7% over the past month, closing at $0.63 [3] - Assertio's consensus EPS estimate has changed by -150% over the past month, indicating a significant downturn compared to the previous year [4]
Journey Medical Corporation Appoints Ramsey Alloush as Chief Operating Officer
Newsfilter· 2025-04-01 20:01
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]
Journey Medical (DERM) - 2024 Q4 - Annual Report
2025-03-27 01:47
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 (DERM) - 2024 Q4 - Earnings Call Transcript
2025-03-26 23:10
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]
Journey Medical Corporation (DERM) Tops Q4 Earnings Estimates
ZACKS· 2025-03-26 22:15
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]