Minocycline Hydrochloride

3月28日，浙江海正药业股份有限公司（简称：海正药业，代码600267）公布2024年度报告。报告显示，公司全年实现营业收入97.87亿元人民币；归母净利润6.01亿元，创历史新高；扣非净利润4.23亿元，实现扭亏为盈。同日，海正药业首次发布2024年度可持续发展报告，该报告替代了社会责任报告，系统呈现了公司在社会责任、环境保护和公司治理（ESG）等领域的实践成果，彰显公司可持续发展的战略决心。海正药业董事长兼总裁肖卫红现场发言3月31日，海正药业在全球营销中心成功举办投资者现场交流会。公司董事长兼总裁肖卫红率领高管团队，以及研发、生产和销售等核心业务部门负责人集体出席。会议吸引了近50位投资机构代表及分析师参与。会上，公司管理层详细介绍了2024年度业绩情况，并就未来发展战略与参会嘉宾进行了深入交流。此次会议为投资者提供了全面了解公司发展现状和未来规划的重要平台。近50位投资机构代表及分析师参与现场交流会01聚焦变革转型，为持续增长奠基2024年，海正药业提出“销售为先，利润归仓”策略，推进一体化管理，运营效率明显改善，销售费用率、应收账款和存货等方面的指标均有改善；2024年扣除医药经销业务部分后，营业收入增长8%，经营活动产生的现金流量净额同比增长40.72%至21.15亿元，资产负债率46.29%，同比下降12.00%，业务逐步往良性态势发展，凸显出公司战略调整的成效。海正药业通过系列变革与转型，推动各板块业务持续健康发展。医药制剂业务（包含CSO）营收增长显著，同比增长6.8%至52.2亿，综合实力上升，公司在IQVIA中国药企权威榜单的排名跃升12位至第26位，并在降脂、抗感染与激素3个关键赛道领域巩固标杆地位，彰显头部优势。重点产品赛斯美2024年销量625.69万盒，同比增加31%，赛斯美品牌通过“医学科普视频矩阵项目”与“海心汇”心血管生态联盟，以数字化重构用户生态，为客户和患者提供更便捷的服务。原料药业务营收同比增长18%至12.3亿，公司积极巩固和拓展国内外市场，人用药业务稳健增长，CMO业务销售额增长显著，英夫马芬净、奥利司他等产品收入同比增加明显。动物药业务作为海正药业重点培育的新兴业务之一，2024年业务规模持续扩大，海正动保疫苗领域的首个重磅产品云圆清、首款宠物疫苗海妙哆等4款重磅新药上市，重点兽药产品销量持续攀升，共有9个单品销售过千万，其中宠物驱虫明星产品海乐妙年度销售连续多年破亿。此外，海正药业加快探索大健康、医美、CXO等新兴业务，据悉，公司目前已启动两项再生类医美制剂的开发立项，预计2026年会进入注册临床阶段。海正药业在多渠道持续发力，助力业务发展。2024年，电商业务全域提速升级，医药制剂重点单品伊索佳、玫满同比大幅增长，多款产品通过线上渠道有效提升患者的购药体验；宠物业务电商业绩突破亿元，5年累计增幅达11倍。国际化步伐加快，年内美国公司成功推动3个新品上市，首年实现净盈利，与3家大型药企签署了独家授权协议，助力中国药企出海。动物药业务完成5个国际注册资料上报，其中海乐旺于今年3月在越南获批。未来动保出海将聚焦东南亚、俄罗斯、南美、中东等市场，逐步拓展海外业务，加强自主运营和品牌主导权。02持续创新研发，巩固技术壁垒2024年，公司通过战略性研发资源重构实现科研效能提升，重点强化心血管、代谢等核心治疗领域资源配置，搭建跨部门协作的矩阵式研发架构。为加速创新药进程，公司新设上海创新药物研发中心，与德睿制药、诺奖团队、中科院微生物所等国内外顶尖科研机构和企业达成战略合作。同时推动搭建小核酸、复杂制剂、AI等先进研发平台，孵化一批潜力新项目，其中HS387项目完成Pre-IND申报；累计获得10项药品注册批件，提交12项国内外注册申请，新启动研发项目42个，全年实现专利申请62项，专利授权30项。2025年，公司计划进一步聚焦主要研发领域、丰富产品管线。海正药业通过技术攻关，赋能工业体系，降本成果显著。2024年，公司已完成在制药、大健康、医美等应用领域研产销一体化布局，合成生物学柔性生产线技改项目开工实施。新产品技术转移已完成10项，2个重点项目有序推进，多个产品恢复生产。公司在生产“质”造领域的深耕获得了权威部门认证，台州、富阳、南通三大生产基地均成功通过FDA现场审计，公司获国家工信部评定的“国家级制造业单项冠军企业”“国家卓越级智能工厂”等荣誉称号，展现海正品质。2025年是海正药业亮剑突围、质变发展的关键之年。公司上下将凝心聚力、真抓实干，集中精力做实做强主营业务，同时积极探索新兴领域，拓展新的增长点，推动公司各项工作实质性地再上新台阶。海正药业将一步一个脚印，为稳健发展筑牢根基。关于海正药业海正药业（股票代码：600267）始创于1956年，是一家国有控股的综合性医药健康产业集团。公司专注于创新药、生物药、仿制药和高端原料药的研发、生产、销售，并布局了动保、大健康、医美等新兴领域。同时依托自身产业技术转化和产能优势，前瞻布局合成生物学，成为该领域的先行者。公司始终坚持对海正品质的卓越追求，积极承担国家战略需求，持续打造具有全球影响力的民族医药健康品牌。如需了解更多信息，请访问www.hisunpharm.com或关注公司官微：海正药业

FDA Approval of Emrosi™ (40 mg Minocycline Hydrochloride Modified-Release Capsules) for Rosacea Emrosi Initial Distribution Ongoing; First Prescriptions Filled Total Revenues for the Full Year Ended December 31, 2024 were $56.1 million Met All Financial Guidance for 2024 Emrosi Phase 3 Clinical Trial Results Published in JAMA Dermatology Company to Hold Conference Call Today at 4:30 p.m. ET SCOTTSDALE, Ariz., March 26, 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 the selling and marketing of 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 full year ended December 31, 2024. Claude Maraoui, Journey Medical’s Co-Founder, President and Chief Executive Officer, said, “We delivered a solid performance in 2024, meeting all of our financial guidance ranges and received first cycle FDA approval for Emrosi™ in November, ahead of the scheduled PDUFA date. Emrosi’s superb Phase 3 clinical results demonstrated its best-in-class profile, and we expect it will become the standard of care and transform our business. Our cash position remains strong ahead of Emrosi’s launch and our objective is to deliver enhanced revenue growth and become sustainably EBITDA positive. I am pleased to report that we have begun distribution of Emrosi, that first prescriptions have been dispensed and that we continue to execute ahead of schedule, with full promotion expected in April 2025.” 2024 Financial Guidance: 2024 Financial Results: Total revenues were $56.1 million for the full year 2024 compared to $79.2 million for the full year of 2023. Product revenue, net decreased $4.5 million, or 8%, to $55.1 million for 2024, from $59.7 million for 2023, due to overall higher rebates costs across the Company’s product portfolio and lower unit sales volumes, mainly from our legacy products. Increases in unit sales volumes for Qbrexza® and Accutane® were offset by higher rebate costs. Other revenue for 2023 reflects a one-time upfront license payment of $19.0 million and $0.5 million in product related royalties for Qbrexza from Maruho Ltd., our exclusive licensing partner in Japan. 2024 reflects a $1.0 million milestone payment pursuant to Journey’s license agreement with Cutia Therapeutics (HK) Limited (“Cutia”) that became payable to us upon Cutia receiving marketing approval for Amzeeq® in the People’s Republic of China. Cost of goods sold (“COGS”) decreased by $2.0 million, or 9%, to $20.9 million for 2024, from $22.9 million for 2023 due to a decrease in product royalties, stemming from the contractual royalty decreases in 2023 and the discontinuation of Ximino. The Company’s gross margin percentage slightly improved from period-to-period, as the cost savings noted above were partially offset by higher product COGS. SG&A expenses decreased by $3.7 million, or 8%, to $40.2 million for 2024, from $43.9 million for 2023. The decrease is mainly due to expense reduction efforts primarily in sales and marketing, partially offset by increases in non-cash share-based compensation expense, Emrosi launch expenses, and increased SG&A related to the expansion of our market access and coverage platforms. R&D expenses were $9.9 million for 2024, compared to $7.5 million for 2023. R&D expenses for 2024 include a $4.1 million application filing fee payment to the FDA for Emrosi, and a $3.0 million milestone payment triggered by the FDA’s acceptance of the Company’s NDA application for Emrosi. Clinical trial expenses were significantly lower than 2023, as clinical development for Emrosi concluded in 2024. The Company’s net loss was $(14.7) million, or $(0.72) per share basic and diluted for the full year 2024, compared to the net loss of $(3.9) million or $(0.21) per share basic and diluted for the full year 2023. Net loss for 2023 includes revenue from the Maruho upfront fee license payment of $19.0 million and $0.5 million in product related royalties. The Company’s non-GAAP results in the table below reflect Adjusted EBITDA of $0.8 million, or $0.04 per share basic and $0.03 per share diluted for the full year 2024. This compares to Adjusted EBITDA of $15.6 million, or $0.85 per share basic and $0.75 per share diluted for the full year 2023. 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 below. At December 31, 2024, Journey Medical’s cash and cash equivalents totaled $20.3 million, compared to $22.5 million on September 30, 2024, and $27.4 million on December 31, 2023, a decrease of $2.2 million for the quarter and a decrease of $7.1 million from the prior-year period. Recent Corporate Highlights: In March 2025, Journey Medical announced publication in the Journal of the American Medical Association - Dermatology of the Phase 3 clinical trial results of Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) to treat rosacea. Emrosi achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks. 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, here. In November 2024, the U.S. FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults. In October 2024, clinical data were presented at the 44th Fall Clinical Dermatology Conference assessing the dermal and systemic pharmacokinetics of Emrosi versus oral Doxycycline 40 mg capsules (Oracea®)1 in healthy subjects. In July 2024, Journey Medical appointed Michael C. Pearce to its Board of Directors. Mr. Pearce is an accomplished executive, with substantial strategic, business and financial expertise across many industries, including healthcare. In April 2024, Journey Medical appointed Joseph M. Benesch as its permanent Chief Financial Officer. Mr. Benesch served as Journey Medical’s Interim Chief Financial Officer since January 2023 and previously, he was Corporate Controller at the Company since November 2021. Conference Call and Webcast InformationJourney Medical management will conduct a conference call and audio webcast on March 26, 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/10197674/feaf5b7354. 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) 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 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-K 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 and amortization, 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, 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. Gain on Extinguishment of Debt: We exclude the gain on extinguishment of debt to settle amounts owed as part of license installment payments, because we consider this to be a non-cash, non-recurring item. Short-Term Research and Development Expense: We exclude research and development costs incurred in connection with Emrosi, formerly referred to as DFD-29, including the filing fee payment made to the FDA and contractual milestone payments, which was the only product in our portfolio not approved for marketing and sale during the 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 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. Loss Recovery: We exclude the loss recovery payment because we consider this to be a one-time, non-recurring source of income. 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: Released March 26, 2025