Key Takeaways Madrigal gained conditional EU approval for Rezdiffra to treat adults with noncirrhotic MASH.The EU nod to Rezdiffra followed positive phase III MAESTRO-NASH data showing fibrosis and MASH benefits.Despite approval, MDGL stock fell as investors eyed competition from Novo Nordisk's Wegovy.Madrigal Pharmaceuticals (MDGL) announced that the European Commission (EC) has granted a conditional marketing authorization to Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic metabolic d ...

Core Viewpoint - Madrigal Pharmaceuticals has received conditional marketing authorization from the European Commission for Rezdiffra, making it the first approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) in the European Union [1][10]. Company Overview - Madrigal Pharmaceuticals, Inc. is focused on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [12]. - Rezdiffra (resmetirom) is a once-daily, oral, liver-directed THR-β agonist designed to address the underlying causes of MASH [8][12]. Product Details - Rezdiffra is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) [9][10]. - The European Commission's decision was based on positive results from the Phase 3 MAESTRO-NASH trial, which demonstrated fibrosis reduction and MASH resolution [3][6]. - At one year, 91% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of liver stiffness [3]. Market Context - MASH is a leading cause of liver-related mortality and is increasingly burdening healthcare systems globally, with approximately 370,000 patients diagnosed in Europe [2][5]. - The approval of Rezdiffra is expected to set a precedent in the treatment of MASH, as it does not require a biopsy for treatment qualification [2][4]. Regulatory Approval - The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025 [4]. - Rezdiffra is included in European MASH treatment guidelines and is expected to launch in Germany in the fourth quarter of 2025 [4][6].

NASDAQ: MDGL © 2025 Madrigal Pharmaceuticals, Inc. All rights reserved. Forward-looking Statements This presentation includes "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal's beliefs and assumptions and on information currently available to it but are subject to factors beyond its control. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regar ...

Summary of CSPC Pharmaceutical Group Conference Call Company and Industry Overview - **Company**: CSPC Pharmaceutical Group (Ticker: 1093.HK) - **Industry**: China Healthcare Key Points and Arguments - **Licensing Agreement**: CSPC has signed a licensing agreement with Madrigal for exclusive development and commercial rights to SYH2086, an oral GLP-1 in preclinical stage. The deal includes an upfront fee of **US$120 million**, potential total milestones of up to **US$1.955 billion**, and a double-digit share of sales royalties [1][6] - **Madrigal's Asset**: Madrigal's lead asset, Rezdiffra (resmetirom), is a once-daily oral THR-beta agonist approved for F2-F3 MASH by the US FDA in March 2024 and is currently undergoing Phase 3 trials for F4c MASH [1] - **Financial Position of Madrigal**: As of March 2025, Madrigal holds **US$848 million** in cash and has a **US$500 million** secured credit facility [1] - **Out-licensing Deals**: This marks CSPC's sixth out-licensing deal in the last 10 months, indicating the company's strong drug discovery platforms and commitment to globalization. The deal is viewed as a positive surprise and is not part of the anticipated **~US$5 billion** in out-licensing deals expected to be completed in 2025 [6] - **Future Expectations**: CSPC is expected to announce two more major out-licensing deals, specifically for SYS6010 (EGFR ADC) and another technology platform [6] Financial Metrics and Valuation - **Stock Rating**: Overweight - **Price Target**: HK$9.60 - **Current Stock Price**: HK$10.10 (as of July 30, 2025) - **Market Capitalization**: HK$120,751 million - **Revenue Projections**: - 2025: **Rmb 29,036 million** - 2026: **Rmb 30,513 million** - 2027: **Rmb 30,978 million** [4] - **Earnings Per Share (EPS)**: - 2025: **Rmb 0.45** - 2026: **Rmb 0.46** - 2027: **Rmb 0.44** [4] - **Valuation Methodology**: Discounted cash flow methodology with a cost of equity of **10.1%** and a perpetual growth assumption of **4%** [7] Risks Identified - **Upside Risks**: - Stronger-than-expected sales ramp-up for innovative drugs - Better-than-expected margin improvement - Pipeline advancement - Increasing business development [9] - **Downside Risks**: - API price fluctuations - Pipeline failures or delays - Rising operating costs - Government price cuts or reimbursement controls [9] Additional Insights - **Analyst Certification**: Analysts involved have certified that their views are accurately expressed and have not received compensation for specific recommendations [14] - **Market Activity**: CSPC is actively involved in the market, with Morgan Stanley acting as a liquidity provider for its securities [57] This summary encapsulates the critical aspects of CSPC Pharmaceutical Group's recent developments, financial outlook, and market positioning, providing a comprehensive overview for potential investors and stakeholders.

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED SYH2086是本集團開發的具有完全自主知識產權的臨床前候選藥物，屬於一種新型口服小 分子GLP -1受體激動劑。GLP -1受體激動劑是一類通過GLP -1受體發揮作用的藥物，已被開 發 為 用 於 2 型 糖 尿 病 和 肥 胖 症 管 理 的 治 療 方 法 ， 其 核 心 作 用 機 制 包 括 促 進 胰 島 素 分 泌 、 抑 制 胰 高 血 糖 素 釋 放 、 延 緩 胃 排 空 及 降 低 食 欲 ， 從 而 兼 具 降 糖 和 減 重 效 果 。 臨 床 前 數 據 顯 示，SYH2086具有優異的體外激動活性和體內降糖、減重效果，並在不同動物種屬上具有 寬劑量範圍線性化的藥物動力學(PK)行為，且無明顯安全性風險。 – 1 – 關於Madrigal Madrigal（ NASDAQ：MDGL ）是一家專注於提供代謝功能 ...

Core Insights - Madrigal Pharmaceuticals has entered into an exclusive global license agreement with CSPC Pharmaceutical Group for SYH2086, a preclinical oral GLP-1 receptor agonist, with plans to initiate clinical development in the first half of 2026 [1][2][3] Group 1: Company Developments - The agreement aligns with Madrigal's long-term goal to enhance its leadership in MASH by building a pipeline anchored by its existing product, Rezdiffra [2] - Madrigal's CEO highlighted the successful launch of Rezdiffra and the acquisition of new intellectual property protection through 2044 as part of their strategic priorities [2] - The combination of Rezdiffra and SYH2086 is expected to provide a best-in-class oral treatment for patients with MASH [2][6] Group 2: Financial Aspects - CSPC will receive an upfront payment of $120 million and may earn up to $2 billion in milestone payments based on the achievement of specific development, regulatory, and commercial milestones [3] - The transaction is expected to close in the fourth quarter of 2025, pending regulatory clearance [3] Group 3: Product Information - SYH2086 is a novel oral small molecule GLP-1 receptor agonist that has shown promising preclinical results, including glucose-lowering and weight-loss effects [4] - GLP-1 receptor agonists are designed to manage type 2 diabetes and obesity by enhancing insulin secretion and reducing appetite [4] Group 4: Industry Context - MASH is a serious liver disease that can lead to severe complications, including cirrhosis and liver cancer, and is a leading cause of liver transplantation [5][7] - The prevalence of MASH is expected to increase, highlighting the need for effective treatments [7]

Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its second-quarter 2025 financial results on August 5, 2025, before the U.S. financial markets open [1] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily oral THR-β agonist targeting the underlying causes of MASH and is the first FDA-approved treatment for MASH with moderate to advanced fibrosis [3] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for treating compensated MASH cirrhosis [3] Investor Relations - Following the financial results announcement, Madrigal's management will host a live webcast at 8 a.m. Eastern Time to discuss the financial and operational results [2] - The webcast will be accessible via the Investor Relations section of the Madrigal Pharmaceuticals website, with a recommendation for participants to register at least 15 minutes prior to the event [2]

Core Insights - Madrigal Pharmaceuticals has received a Notice of Allowance from the USPTO for Rezdiffra™, the first FDA-approved treatment for adults with noncirrhotic MASH with moderate to advanced liver fibrosis [1][2] - The patent protection for Rezdiffra is set to last until September 30, 2044, and will be included in the FDA's Orange Book [2] - The CEO of Madrigal emphasized that this milestone supports the company's long-term strategy for Rezdiffra and highlights the significance of their clinical development program [3] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - Rezdiffra (resmetirom) is a once-daily oral THR-β agonist aimed at addressing the underlying causes of MASH, specifically approved for patients with moderate to advanced fibrosis (F2 to F3 stages) [3] - An ongoing Phase 3 trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c stage) [3]

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need [3] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA-approved treatment for MASH with moderate to advanced fibrosis [3] Equity Awards Announcement - On June 15, 2025, Madrigal granted equity awards to 36 new non-executive employees as part of its 2023 Inducement Plan [1] - The total equity awards included options to purchase 2,184 shares of common stock and 21,125 time-based restricted stock units [2] - The exercise price for the options is set at $295.57 per share, equal to the closing price on the grant date, with a vesting schedule that includes 25% vesting on the first anniversary and 6.25% vesting quarterly thereafter [2]

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist targeting the underlying causes of MASH [2] - Rezdiffra is the first and only medication approved by the FDA for treating MASH with moderate to advanced fibrosis, specifically stages F2 to F3 [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis, corresponding to stage F4c [2] Upcoming Events - Madrigal Pharmaceuticals will participate in the 46th Annual Global Goldman Sachs Health Care Conference on June 11, 2025, at 10:40 A.M. EDT [1] - The presentation will be available via live webcast, with a replay accessible after the event [1]