Summary of HUTCHMED (HCM) Conference Call Company Overview - **Company**: HUTCHMED (HCM) - **Industry**: Biotechnology and Pharmaceuticals Key Points Financial Performance - **1H25 Earnings Results**: Total topline revenue of $277.7 million, which is -13% and -18% below Goldman Sachs estimates of $337.8 million and Visible Alpha consensus of $318.1 million respectively [1][4] - **Earnings per Share (EPS)**: Reported at $0.52, significantly above estimates due to a one-time gain of $477.5 million from reducing stake in SHPL from 45% to 5% [1][4] - **Revenue Guidance**: FY25 consolidated oncology revenue guidance reduced to $270 million - $350 million from $350 million - $450 million [1][4] Market Dynamics - **Challenges in China**: Increased competition for core products (Elunate, Sulanda, Orpathys) and regulatory changes affecting sales and marketing teams [1][4] - **Sales Performance**: - **Elunate**: Sales decreased by -29% year-over-year due to competition and generics [4] - **Sulanda**: Sales decreased by -50% attributed to competition from new somatostatin analogue drugs [4] - **Orpathys**: Sales declined by -41% due to competing drugs being added to the National Reimbursement Drug List (NRDL) [4] - **Fruzaqla Growth**: Sales increased by 25% outside China, primarily driven by market expansion in Europe and Japan, though growth in the US was moderate due to competition [1][4] Pipeline and Future Outlook - **Sovleplenib**: NDA re-submission delayed; targeting re-submission in 1H26 [5] - **Savolitinib**: Enrollment ongoing in Phase 3 SAFFRON study, potential for global regulatory filings if successful [5] - **ATTC Platform**: New antibody-targeted therapy conjugates platform with preclinical data expected later this year, initial partner responses are positive [6] Model Adjustments - **Revenue Estimates**: Adjustments made to reflect 1H25 actuals and increased competition, leading to lower near-term revenue estimates [8] - **2025 Estimates**: Revenue revised down to $583.3 million from $688.3 million, reflecting a -15.3% change [9] Valuation and Risks - **Price Target**: Maintained at $18 for ADR listed in the US, with a 12-month upside of 10.4% [12][14] - **Key Risks**: Include clinical success/failure, regulatory risks, financial risks under HFCAA, and potential for better-than-expected commercial sales [12] Conclusion - **Investment Rating**: Neutral, with ongoing monitoring of pipeline progress and commercial recovery potential in China [1][12]

Core Insights - The SACHI Phase III study demonstrated that the combination of savolitinib and osimertinib significantly improves progression-free survival (PFS) in patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) with MET amplification compared to chemotherapy [1][4][9] Study Overview - SACHI is a Phase III clinical trial focusing on the combination of savolitinib and osimertinib for treating patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after progression on first-line EGFR inhibitor therapy [2] Efficacy Results - In the intention-to-treat population, the median PFS was 8.2 months for the savolitinib plus osimertinib group versus 4.5 months for the chemotherapy group, with a hazard ratio (HR) of 0.34 [4] - The independent review committee assessed median PFS at 7.2 months for the combination therapy compared to 4.2 months for chemotherapy, with an HR of 0.40 [4] - The objective response rate (ORR) was 58% for the combination group compared to 34% for chemotherapy, and the disease control rate (DCR) was 89% versus 67% [5] Safety Profile - The combination therapy exhibited a tolerable safety profile, with treatment-emergent adverse events of Grade 3 or above occurring in 57% of patients in both the savolitinib plus osimertinib and chemotherapy groups [7][8] Regulatory Status - The Independent Data Monitoring Committee concluded that the study met its primary endpoint of PFS, leading to the conclusion of patient enrollment [9] - A New Drug Application (NDA) for the combination therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA) [9] Company Background - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [13]

Core Insights - HUTCHMED is set to present new data on its compounds at the ASCO Annual Meeting from May 30 to June 3, 2025, in Chicago, USA [1] Group 1: Savolitinib - The SACHI Phase III study results of savolitinib in combination with osimertinib for EGFR mutation-positive NSCLC will be presented, showing that it met the primary endpoint of progression-free survival (PFS) [2] - Additional data from the SAVANNAH Phase II study indicates that the combination of savolitinib and osimertinib showed better efficacy outcomes compared to savolitinib plus placebo, with promising CNS activity [3] Group 2: Ranosidenib - Results from the Phase I study of ranosidenib (HMPL-306) indicate it was well tolerated, with target inhibition and durable responses, particularly in lower-grade glioma patients, showing an objective response rate (ORR) of 7.1% and a disease control rate (DCR) of 100% [4] Group 3: Fruquintinib - The FRUSICA-1 Phase II study results for fruquintinib plus sintilimab in advanced endometrial cancer patients showed an ORR of 37.0% and a DCR of 88.9%, with durable responses regardless of prior chemotherapy [5] - A Phase IV study involving 2,798 colorectal cancer patients demonstrated a manageable safety profile for fruquintinib, with Grade 3 or above treatment-emergent adverse events occurring in 23.94% for monotherapy and 26.06% for combination therapy [6]

Company Overview - HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [12]. Recent Developments - HUTCHMED announced new and updated data from studies of its compounds, including savolitinib, fruquintinib, and surufatinib, which will be presented at the American Association of Cancer Research (AACR) Annual Meeting 2025 [1]. - The company is actively involved in multiple clinical trials, including the SACHI and SAFFRON trials, assessing the combination of savolitinib with TAGRISSO® (osimertinib) for treating patients with advanced non-small cell lung cancer (NSCLC) [10][11]. Product Information - Savolitinib is a selective MET tyrosine kinase inhibitor developed by HUTCHMED and AstraZeneca, approved in China for treating adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alterations [7][6]. - Fruquintinib is being studied in various treatment regimens for metastatic colorectal cancer (mCRC), with ongoing trials evaluating its efficacy in combination with other therapies [2][3]. Market Context - Lung cancer is the leading cause of cancer death globally, with NSCLC accounting for approximately 80% of cases. A significant portion of NSCLC patients in Asia have epidermal growth factor receptor (EGFR) mutations, which are targetable by therapies like savolitinib [4][5]. - The prevalence of MET aberrations in NSCLC patients who progress after EGFR TKI treatment is notable, with studies indicating that 15-50% of these patients may present with such mutations [8][9]. Clinical Trial Highlights - The SACHI trial met its primary endpoint of progression-free survival (PFS) during its interim analysis, leading to the acceptance of a New Drug Application (NDA) in China [10]. - The SAFFRON trial is ongoing, assessing the combination of savolitinib and TAGRISSO® against platinum-based chemotherapy in a specific patient population [11]. Future Prospects - HUTCHMED is focused on expanding the clinical development of its compounds, with promising data from ongoing trials expected to support potential regulatory filings in the US and other global markets [9][11].