文章核心观点 - 公司的首款药物Rezdiffra是目前唯一获批治疗代谢相关性脂肪肝炎(MASH)的药物,市场前景广阔 [6][7][12][13] - 公司有望在未来10-20年内实现10-20倍的股价增长,从而使投资者获得百万美元级别的收益 [4][8][9] - 但公司未来面临来自竞争对手的挑战,可能无法完全垄断MASH治疗市场 [14][15] 行业分析 - MASH是一个严重的公共卫生问题,每年有一半的患者病情会恶化,80%最终发展为肝硬化 [11] - MASH治疗市场未来有望达到200-350亿美元的规模 [7] - 目前公司的Rezdiffra是唯一获批治疗MASH的药物,但其他大型制药公司也在研发同类产品 [13][14] 公司分析 - 公司的首款药物Rezdiffra已获批上市,正在进行适应症扩展的研发工作 [6] - 公司有望在未来10-20年内实现10-20倍的股价增长,从而使投资者获得百万美元级别的收益 [4][8][9] - 但公司未来面临来自竞争对手的挑战,可能无法完全垄断MASH治疗市场 [14][15]

The coast is clear for it to grow, for now.Madrigal Pharmaceuticals (MDGL 0.21%) is in a position that most other biotechs envy. Its first medicine just hit the market, sales are due to start rolling in, and there aren't any other companies that can slow it down -- for now, that is.By mid-2027, its shareholders will probably be richer than they are today. But beyond that time point, all bets are off, and in fact, it's very possible for things to start getting more difficult for Madrigal a bit sooner. Here's ...

Success isn't guaranteed, but both companies could become big winners.Viking Therapeutics (VKTX -0.84%) and Madrigal Pharmaceuticals (MDGL -1.41%) are highly prominent biotech companies that have a lot in common. Both focus on treating metabolic illnesses like liver disease and obesity, and, until recently, despite their promising pipeline programs, both were lacking any products on the market to generate revenue.Now, the picture is shifting, and the odds are good that one of these players will pull ahead o ...

Late-breaking AI-based analysis of MAESTRO-NASH biopsy data demonstrates Rezdiffra improved key fibrotic features that are predictive of progression to decompensated cirrhosisNoninvasive test data through three years of treatment demonstrate durable treatment response to Rezdiffra; 91% of patients achieved improvement or stabilization of liver stiffness First analysis of health-related quality of life data from MAESTRO-NASH demonstrates Rezdiffra improved patient worry, health distress and stigmaFirst analy ...

It's not the most prominent biotech, but it has an important claim to fame.Madrigal Pharmaceuticals' (MDGL -0.79%) shares are down by 27% over the past year, while the S&P 500 is up by 26%. However, this poor performance hardly reflects the progress the biotech has made. Madrigal recently earned regulatory approval for Rezdiffra, a therapy for non-alcoholic steatohepatitis (NASH). Not only was Rezdiffra Madrigal's first product on the market, but it is also the first and only approved by the U.S. Food and D ...

财务数据和关键指标变化 - 公司在第一季度没有录得任何Rezdiffra收入 [35] - R&D费用为7100万美元,较上年同期增加9百万美元,主要是由于制造、人员增加、研究组活动和股份支付费用的时间性影响 [37] - SG&A费用为8100万美元,较上年同期增加6500万美元,主要是由于商业运营的扩张 [38][39] - 公司在4月完成了6.9亿美元的公开发行,截至3月31日现金余额为11亿美元,为Rezdiffra的多年推广提供了充足资金 [40] 各条业务线数据和关键指标变化 - 公司目前专注于Rezdiffra的上市推广,尚未报告其他业务线的数据 各个市场数据和关键指标变化 - 公司正在积极与医保公司进行谈判,目前已有30%的商业医保覆盖,计划在年底达到80%的覆盖率 [23] - 公司对退伍军人事务部(VA)的决定感到失望,但认为这只是短期的,未来将继续与VA合作以纠正这一决定 [56][57] 公司战略和发展方向及行业竞争 - 公司目标是成为NASH领域的领导者,正在积极推进Rezdiffra在美国和欧洲的上市 [61][62] - 公司认为Rezdiffra的产品特征和首创地位将为其带来持久的竞争优势 [12][13][15] - 公司正在进行MAESTRO-NASH临床试验,以获得Rezdiffra在预防肝衰竭等预后终点事件的数据,进一步巩固其地位 [29][30][31] - 公司认为即使其他公司开发出与Rezdiffra类似的疗效,Rezdiffra仍有足够的市场空间和优势 [82][83] 管理层对经营环境和未来前景的评论 - 管理层对Rezdiffra的上市推广进展感到非常满意和乐观,认为其具有巨大的市场潜力 [10][11][33] - 管理层认为公司有足够的资源和经验团队来确保Rezdiffra的成功上市 [14] - 管理层表示正在积极与医保公司进行谈判,并期待医学会发布新的NASH治疗指南 [22][23] 问答环节重要的提问和回答 问题1 **Yasmeen Rahimi 提问** 询问公司与医保公司谈判的情况,是否存在差异 [44] **Bill Sibold 回答** 公司正在与各大医保公司进行积极沟通,目前尚未发现明显差异,预计到年底将有80%的商业医保覆盖 [45][46][47] 问题2 **Eli Merle 提问** 询问公司前10%重点目标医生的处方情况,以及医生对使用医疗例外的反馈 [50] **Bill Sibold 回答** 公司75%的处方来自前6000名重点目标医生,大部分医生目前都需要通过医疗例外的方式开具处方 [51][52][53] 问题3 **Liisa Bayko 提问** 询问退伍军人事务部(VA)对Rezdiffra的覆盖要求,以及VA患者占比 [55] **Bill Sibold 和 Mardi Dier 回答** VA目前要求进行肝活检,这与指南不符,公司将继续与VA沟通以纠正这一决定。VA患者占比较小,对公司影响有限 [56][57][58]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________________ FORM 10-Q _________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR o 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: 001-33277 _________________________ MADRIGAL PHARMACEUTICALS, ...

Exhibit 99.1 Madrigal Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates • On March 14, 2024, received U.S. FDA approval of Rezdiffra™ (resmetirom) for the treatment of patients with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis • In April 2024, product shipped and first patients received Rezdiffra, the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”) • On March 5, 2024, announc ...

mikkelwilliam Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) achieved history in March by garnering US FDA approval for Rezdiffra (resmetirom), the first drug specifically indicated for nonalcoholic steatohepatitis (NASH). On April 9, 2024, MDGL announced the availability of Rezdiffra meaning the launch of this first-to-market drug is now underway. In this article, I consider the prospects of the drug and the expectations I think the market might have. The approval and the market MDGL's Rezdiffra is approved ...

Madrigal团队对Stephen Harrison博士的去世感到震惊和悲伤 - Stephen是Madrigal许多同事和朋友，他不懈努力改善患有非酒精性脂肪性肝炎（NASH）的人们的生活[1] - Stephen不仅是一位杰出的研究者和医生，更是一位真正的领导者，激励着所有人[2]