Minocycline

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 (Nasdaq: DERM) (“Journey Medical” or “the Company”, “we”, or “our”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”) approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced financial results and recent corporate highlights for the first quarter ended March 31, 2025. “The first quarter of 2025 was highly productive, as our in-line dermatology products continue to perform and the launch of Emrosi™, our best-in-class oral rosacea treatment, is off to a strong start,” said Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer. “The Emrosi launch is enjoying high visibility among dermatology prescribers with momentum from our exhibition booth at the American Academy of Dermatology (AAD) conference in late March, the recent publication of Emrosi’s statistically superior Phase 3 clinical trial results over Oracea® and placebo in JAMA Dermatology, and the promotional efforts from our experienced and highly effective dermatology salesforce. Emrosi was also recently incorporated into the National Rosacea Society’s Rosacea Treatment Algorithms, and payer coverage of the product continues to increase.” Mr. Maraoui continued, “Financially, we remain in a strong position with $21.1 million in cash as of March 31, an improvement in our gross margin, and overall operating spend down year-over-year. We believe that our first quarter financial results and launch progress with Emrosi demonstrate that we are executing on our strategic objectives, and that 2025 will be a transformational year for the Company as we drive the business to sustainable positive EBITDA and profitability.” Financial Results: Total net product revenues of $13.1 million for the first quarter of 2025 were consistent with $13.0 million of net product revenues for the first quarter of 2024. The first quarter of 2025 includes $2.1 million of incremental net product revenue related to the U.S. commercial launch of Emrosi. The Company’s gross margin(1) increased to 64% for the first quarter of 2025, from 54% in the prior period due to lower overall product cost of goods related to product sales mix and non-recurring charges in the prior year. Research and development costs were nil in the first quarter of 2025, compared to $7.9 million in the first quarter of 2024. The first quarter of 2024 includes Emrosi pre-approval project expenses, milestones and fees. Selling, general and administrative expenses increased by $2.1 million for the three-month period ended March 31, 2025, from $8.4 million for the three-month period ended March 31, 2024. The increase is primarily due to the incremental operational activities related to the launch and commercialization of Emrosi. The Company’s net loss was $4.1 million, or $(0.18) per share basic and diluted, for the first quarter of 2025, compared to a net loss of $10.4 million, or $(0.53) per share basic and diluted, for the first quarter of 2024. At March 31, 2025, the Company had $21.1 million in cash and cash equivalents as compared to $20.3 million in cash and cash equivalents at December 31, 2024. Recent Corporate Highlights: In April 2025, Journey Medical appointed Ramsey Alloush as its Chief Operating Officer. Mr. Alloush joined the Company as General Counsel in 2020. At the end of March 2025, Journey Medical announced initial distribution to pharmacies and first prescriptions filled. Full commercial launch began on April 7, 2025. In March 2025, the Journal of the American Medical Association - Dermatology published the Phase 3 clinical trial results of Emrosi for the treatment of rosacea, highlighting that Emrosi achieved the co-primary and all secondary endpoints in two Phase 3 trials and demonstrated statistical superiority against both Oracea(2) and placebo with no significant safety issues when administered once daily for 16 weeks. In March 2025, the National Rosacea Society published its updated Rosacea Treatment Algorithms to include low-dose oral minocycline (referenced in the brand index as Emrosi™). The Updated Treatment Algorithms can be accessed at https://www.rosacea.org/physicians/rosacea-treatment-algorithms. Information on such website is not a part of this release. In February 2025, Journey Medical hosted a conference call and webcast to discuss its U.S. commercial launch plan for Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules) for the treatment of rosacea. A replay of the webcast is available on the IR calendar page of the Journey Medical website, and can be accessed at https://ir.journeymedicalcorp.com/new-events/ir-calendar. Information on such website is not a part of this release. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on May 14, 2025, at 4:30 p.m. ET. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference here: https://dpregister.com/sreg/10199519/ff117b0a70. Please note that registered participants will receive their dial-in number upon registration. A live audio webcast can be accessed on the News and Events page of the Investors section of Journey Medical’s website, www.journeymedicalcorp.com, and will remain available for replay for approximately 30 days after the meeting. (1) We define gross margin as net product revenue less cost of goods sold divided by net product revenue.(2) Oracea® is a registered trademark of Galderma Holdings, S.A. Société Anonyme. About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight branded FDA-approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking StatementsThis press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, Emrosi™, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@jmcderm.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com Use of Non-GAAP Measures: In addition to the GAAP financial measures as presented in our Form 10-Q that will be filed with the Securities and Exchange Commission (“SEC”), the Company has, in this press release, included certain non-GAAP measurements, including Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted. We define Adjusted EBITDA as net income (loss) excluding interest, taxes and depreciation, less certain other non-cash and infrequent items not considered to be normal, recurring operating expenses, including, share-based compensation expense, amortization and impairments of acquired intangible assets, inventory step-ups from the purchases of intangibles assets and products, severance, short-term research and development expense and foreign exchange transaction losses. In particular, we exclude the following matters for the reasons more fully described below: Share-Based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued. Non-core and Short-term Research and Development Expense: We exclude research and development costs incurred principally in connection with Emrosi, which was the only product in our portfolio not currently approved for marketing and sale during the prior-year reporting period, because we do not consider such costs to be normal, recurring operating expenses that are core to our long-term strategy. Instead, our long-term strategy is focused on the marketing and sale of our core FDA-approved dermatological products and the out licensing our intellectual property and related technologies. Amortization and impairments of Acquired Intangible assets: We exclude the impact of certain amounts recorded in connection with the acquisitions of intangible assets that are either non-cash or not normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization impairments of acquired intangible assets and amortization of step-ups of acquisition accounting adjustments to inventories. Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are determined by dividing the resulting Adjusted EBITDA by the number of shares outstanding on an actual and fully diluted basis. Management believes the use of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making, (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance and (iii) it is used by institutional investors and the analyst community to help analyze the Company's results. However, Adjusted EBITDA, Adjusted EBITDA per share basic, Adjusted EBITDA per share diluted and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors. The table below provides a reconciliation from GAAP to non-GAAP measures: The Company’s non-GAAP results in the table above reflect an Adjusted EBITDA loss of $0.9 million, or $(0.04) per share basic and diluted, for the first quarter of 2025, compared to Adjusted EBITDA income of $11,000, or $0.00 per share basic and diluted, for the first quarter of 2024. Adjusted EBITDA, Adjusted EBITDA per share basic and Adjusted EBITDA per share diluted are non-GAAP financial measures, each of which are reconciled to the most directly comparable financial measures calculated in accordance with GAAP above. Released May 14, 2025

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ELCC 2025 微专辑扫描二维码可查看更多内容在2025年欧洲肺癌大会（ELCC）上，巴黎居里研究所肿瘤内科主任Nicolas Girard教授重磅发布SOHO-01和COCOON试验数据，并作题为"胸腺上皮肿瘤全身治疗最新进展"的专题报告。应《肿瘤瞭望》邀请，Girard教授对SOHO-01和COCOON研究结果以及胸腺上皮肿瘤治疗进展进行了深度解读。您在2025 ELCC报告了I/II期SOHO-01研究的两个扩展队列的结果（摘要3O）。请谈谈BAY 2927088对既往接受过治疗HER2突变型非小细胞肺癌（NSCLC）患者的安全性和有效性。Dr. Girard：HER2突变型NSCLC是NSCLC的一小部分，占2-4%。BAY 2927088是一种口服酪氨酸激酶抑制剂，可以抑制HER2。SOHO-01研究评估了BAY 2927088在HER2突变型NSCLC患者中的疗效。在剂量扩展阶段采用每日两次，每次20 mg的剂量。我在2025年ELCC大会上展示了两组患者的研究结果。第一组患者是未接受过HER2靶向治疗但之前接受过全身治疗的患者（n=44）；第二组患者是之前接受过HER2靶向抗体药物偶联物（ADC）治疗的患者（n=34）。第一组患者中，研究者评估的客观缓解率（ORR）高达70.5%，疾病控制率（DCR）为81.8%，中位缓解持续时间（DOR）长达8.7个月，意味着患者在接受化疗±免疫治疗后，BAY 2927088疗法仍具有很高的疗效。第二组患者中（超过一半的患者之前接受过≥三线治疗），ORR为35.3%，DCR为52.9%，中位DOR为9.5个月，在接受化疗、免疫检查点抑制剂和ADC治疗后别无选择的情况下，这个数字相当高。BAY 2927088的安全性主要体现在腹泻（1/2级），目前没有患者因腹泻而停药。腹泻是最常见的副作用，我们可能需要对腹泻进行预防性治疗。我们正在进行一项III期临床试验SOHO-02，该试验旨在对比HER2突变型NSCLC患者接受一线BAY 2927088和化疗+免疫治疗。（上下滑动可查看）Dr. Girard: I am Nicolas Girard. I am Head of Medical Oncology at Institut Curie in Paris.HER2 NSCLC is a small subset of NSCLC, 2-4%. We have BAY 2927088 (BAY 88), which is an oral tyrosine kinase inhibitor that is inhibiting HER2. The SOHO-01 study assessed this compound in patients with EGFR HER2-mutated NSCLC. After dose expansions, dosing of 20mg twice daily was chosen for expansion. At ELCC 2025, I presented the results of two cohorts. The first one being a cohort of patients who were HER2-targeted therapy naïve, but who had previously received systemic therapy, The second was patients who had received prior treatment with HER2-targeting antibody-drug conjugates. Forty-four patients and 34 patients were treated respectively. What we see from the SOHO-01 trial is a high response rate in HER2-targeted treatment naïve patients – 72%, which is quite high. There was a duration of efficacy of 9 months in this cohort of patients is quite long. It means that after treatment with chemotherapy plus or minus immunotherapy, BAY 88 has a high efficacy. The second cohort were previously treated patients with three or more lines of therapy in more than half the patients. We see a response rate of 35% and a control rate of 53%. This is quite high in the setting of having no more option after treatment with chemotherapy, IO and ADCs. The safety of BAY 88 was mostly diarrhea (grade 1/2), with no discontinuation due to diarrhea. We probably need to implement prophylactic management for diarrhea, which was the most frequent side effect. We have an ongoing phase III trial, SOHO-02, in the first-line setting, versus chemotherapy and immunotherapy for patients with EGFR-mutated NSCLC.根据您在2025 ELCC汇报的COCOON试验结果（摘要10MO），对于接受埃万妥单抗联合兰泽替尼治疗的EGFR突变型晚期NSCLC患者，如何预防中度至重度皮肤不良事件？Dr. Girard：COCOON试验的主要目的是评估预防性治疗能否降低EGFR突变型局部晚期/转移性NSCLC患者接受埃万妥单抗+兰泽替尼治疗前12周出现的≥2级皮肤病副作用。EGFR突变NSCLC的标准治疗方案是奥希替尼，在中国和亚洲还有其他第三代TKI可选。随着MARIPOSA研究证明埃万妥单抗联合兰泽替尼相比奥希替尼显著改善总生存期（两组中位总生存差异超过1年），该疗法将成为此类患者一线治疗的新标准。然而，埃万妥单抗联合兰泽替尼的皮肤不良反应发生率较高，尤其是在治疗的前四个月。COCOON研究评估了预防性皮肤病治疗（口服多西环素或米诺环素12周，随后头皮涂抹克林霉素乳液；指甲涂抹氯己定手液；身体和面部涂抹神经酰胺保湿霜）与标准治疗相比，能否改善埃万妥单抗+兰泽替尼的皮肤毒性。在中位随访期约4个月早期时间点进行的首次中期分析中，预防性方案带来获益，前12周≥2级皮肤不良事件（AE）（76.5% vs. 38.6%）和3级皮肤AE（8.8% vs. 4.3%）发生率仅为标准治疗组的50%，因不良事件导致的停药率降低了50%。显然，根据MARIPOSA试验进行埃万妥单抗联合兰泽替尼治疗时，必须同时采用COCOON预防性方案，同时配合静脉血栓栓塞症（VTE）预防以及输液相关反应的预防。（上下滑动可查看）Dr. Girard: The COCOON trial had the objective of assessing whether prophylactic dermatologic management could prevent Grade 2 or higher dermatological side effects that are associated with the administration of amivantamab plus lazertinib in patients with EGFR-mutated NSCLC. For EGFR-mutated NSCLC, the historic standard-of-care is osimertinib, and there are other third-generation TKIs available in China and Asia. Amivantamab plus lazertinib demonstrate an overall survival benefit versus osimertinib. This is a significant benefit with > 1 year difference in median overall survival. So, it is a new standard-of-care for first-line treatment in these patients. But this combination has been associated with high rates of dermatologic adverse effects, especially in the first four months. COCOON assessed whether prophylactic dermatologic management versus standard-of-care could improve this situation. COCOON is doxycycline, clindamycin lotion, chlorhexidine wash for hands and feet, and a ceramide-based moisturizer on the body and face. At the first interim analysis at the early timepoint of four months median follow-up, we see a benefit with COCOON regimen from 77% of patients presenting with Grade 2 or higher dermatologic adverse events after 12 weeks of follow-up to 40% of patients. So, it is a two-fold decrease in the incidence of dermatological adverse events – a two-fold decrease in Grade 3 events, a two-fold decrease in dose modification of amivantamab plus lazertinib. Clearly, this goes with MARIPOSA with amivantamab and lazertinib. COCOON has to be implemented as part of this treatment together with along with venous thromboembolism (VTE) prophylaxis, and prophylaxis for infusion-related reactions.您在2025 ELCC汇报了“胸腺上皮肿瘤全身治疗的最新进展”，请分享这项报告的主要内容。Dr. Girard：晚期或转移性胸腺上皮肿瘤领域近期取得多项进展。在一线治疗中，除了历史悠久的细胞毒性化疗外，一些临床试验探索了新方案，例如化疗（卡铂-紫杉醇）联合抗血管生成药物（包括雷莫芦单抗和贝伐珠单抗）。近期研究显示，化疗联合抗血管生成药物的三联方案（卡铂+紫杉醇+雷莫芦单抗）可显著延长无进展生存期（相比传统化疗的数据），可能成为这类患者的优选方案。当前治疗模式正从单纯化疗向“化疗+抗血管生成药物±免疫疗法”转变。二线治疗选择包括化疗药物、抗血管生成药物（例如舒尼替尼和仑伐替尼）以及免疫检查点抑制剂（单药或联合抗血管生成药物）。同样，联合策略和用药顺序正在发生变化。好消息是，胸腺上皮肿瘤的治疗有了更多选择。（上下滑动可查看）Dr Girard: A lot is coming in thymic epithelial tumors. We have the historic cytotoxic chemotherapy regimens for the first-line treatment of patients with advanced metastatic thymic tumors. We have some new trials combining chemotherapy (carboplatin-paclitaxel) with antiangiogenic agents, including ramucirumab, and bevacizumab. This may be one option for those patients. We have also seen data with combination of chemotherapy plus antiangiogenic agents, a triad of carboplatin plus paclitaxel plus ramucirumab, reporting quite prolonged progression-free survival, which is probably the best endpoint in these patients. There is movement away from chemotherapy alone to combinations of chemotherapy plus antiangiogenic agents plus immunotherapy. In the second-line setting, we have chemotherapy, we have antiangiogenic agents, sunitinib for thymoma, lenvatinib for thymic carcinoma, immune checkpoint inhibitors as single agent or combined with antiangiogenic agents. Again, the combinations and sequence are moving. What is good is that we have more options for the management of those patients.《肿瘤瞭望》在ELCC现场报道（来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。