HUTCHMED H2 Earnings Call Highlights

HUTCHMED (NASDAQ:HCM) management used its 2025 annual results call to highlight growth in global sales for FRUZAQLA, a rebound in China market performance in the second half, and increasing investment behind its ATTC (antibody-targeted therapy conjugate) platform as it advances multiple assets into clinical development.

2025 highlights: overseas growth for FRUZAQLA and a second-half rebound in China

Acting CEO and CFO Johnny Zheng said the company was “very satisfied” with FRUZAQLA’s performance in overseas markets, citing a 26% year-over-year increase and market sales of $366 million. He added that FRUZAQLA has now launched in more than 38 countries.

On the China side, management pointed to a sharp improvement in the back half of the year. Zheng said China market sales in the second half rebounded strongly, with market sales up 21% versus the first half.

Financial review: oncology business revenue, profitability, and R&D spend

Deputy CFO Lorenzo Zhao reported total 2025 oncology business revenue of $286 million, which included $71 million of R&D-related upfront payments, milestones, and service income. He reiterated the second-half rebound in domestic oncology product performance and continued overseas expansion for FRUZAQLA.

Zhao said consolidated profit reached $457 million, which he attributed primarily to a $416 million gain from divesting part of the company’s SPL equity interest. He added that even without the transaction-related gain, the company’s core business remained profitable.

R&D spending was $148 million in 2025, down from 2024. Zhao attributed the decline to some high-cost registration clinical trials moving into later stages, several new drug approvals under review, and a shift of resources toward ATTC programs, including two new products that have entered clinical trials.

Management also emphasized cash resources. Zheng said the company had about $1.4 billion in cash reserves, which he described as supporting accelerated global development of ATTC programs and providing capacity to pursue in-licensing and M&A opportunities.

2026 outlook: oncology business revenue guidance and drivers

For 2026, Zhao provided oncology business revenue guidance of $330 million to $450 million, describing it as steady growth from 2025. Management said key drivers include stronger domestic oncology product growth under new administrative initiatives, continued overseas expansion for FRUZAQLA, and potential new partnering opportunities related to ATTC and other pipeline candidates.

In the Q&A, Zhao said the company did not provide formal guidance for R&D expense. However, he indicated spending could rise as ATTC development progresses, potentially returning toward 2024 levels over time and ultimately reaching a range of about $200 million to $300 million, which he framed as an indicative range rather than official guidance.

Commercial update: China performance, reimbursement, and competitive dynamics

Commercial lead George Yuan discussed FRUZAQLA’s performance under partner Takeda internationally, again citing 26% growth and $366 million in sales in Takeda territories, driven by new market launches and accelerating second-half growth. Yuan highlighted strong performance in Japan and reimbursement expansion in some EU countries, while noting that changes in U.S. federal medical insurance created headwinds consistent with broader industry impacts.

In China, Yuan said the business had faced a “-13” performance previously, which he attributed to the failure of a late-stage prostate cancer indication (referred to on the call as not being approved), which in turn required salesforce and structural adjustments. He said the company carried out reorganization and productivity initiatives, contributing to weaker first-half performance, but that the business “successfully reversed” the situation in the second half with strong growth.

Yuan said the company successfully renewed national reimbursement and added a second-line endometrial cancer indication into reimbursement while maintaining price. He also noted an RCC second-line indication submission and said these steps create a platform for continued growth into 2026.

He also addressed other products, stating that ORPATHYS and SUTENT represented about 11% of the company’s broader commercial portfolio and faced intensified competition during the year. Despite that, Yuan cited several items he said could support future growth for savolitinib, including reimbursement coverage for first-line MET exon 14 skipping and approval in China for the SACHI indication (EGFR-mutant resistant patients with MET amplification). For SUTENT, he said the company continues to see room for growth in neuroendocrine tumors, citing opportunity to improve disease awareness and diagnosis rates, and said reimbursement was successfully renewed through 2026. He added that a Phase 3 registration study in pancreatic cancer is progressing normally.

In response to an analyst question on domestic FRUZAQLA growth, Yuan said the second-half increase was driven mainly by endometrial cancer rather than colorectal cancer, noting that endometrial cancer had not previously been included in reimbursement, limiting its earlier contribution.

Pipeline and R&D: savolitinib milestones, sovleplenib NDA resubmission, and ATTC enters the clinic

R&D head Dave (Guangshu) reviewed regulatory and clinical progress across oncology, hematology, and the ATTC platform. In oncology, he said savolitinib reached key registration and clinical milestones in China and globally. He said SACHI was approved in China for second-line EGFR-mutant MET-amplified NSCLC, and that the SONOVA (China Phase 3) and SAPHIR (global multicenter Phase 3) studies completed Phase 3 enrollment in 2025. He added that an NDA for third-line gastric cancer in China had been submitted and accepted with priority review.

Dave also discussed published and presented data for SACHI, including results he said were published in The Lancet in 2026. He stated that in patients who had not received subsequent MET inhibitors, overall survival improved from 7.9 months to 22.9 months with the savolitinib and osimertinib combination versus chemotherapy. He also cited ASCO 2025 disclosures indicating improvements in ORR and DOR and a statistically and clinically meaningful improvement in PFS.

In hematology, Dave said the company resubmitted an NDA in China for sovleplenib (HMPL-523) in ITP in February 2026 and received breakthrough therapy and priority review designations. He highlighted three-year follow-up data presented at ASH 2025, including an average drug exposure duration of more than 86 weeks, cumulative durable response time over 66 weeks, and 51.4% of patients achieving long-term sustained remission under the criteria described on the call. He emphasized safety differentiation versus TPO/TPO-R agonists, particularly around thrombotic risk.

Dave also described the market opportunity in ITP, stating that in China about 250,000 ITP patients are actively receiving treatment and that the potential market value was estimated at $500 million to $700 million.

On ATTC, Dave said the platform has entered clinical-stage development. He said two ATTC products—251 and 580—are in global clinical development: 251 began recruiting patients in China and the U.S. in December 2025, and 580 enrolled its first patient just days before the call. He also said a third ATTC product, 830, is expected to enter global Phase 1 in the second half of the year. He described 251 as a first-in-class ATTC that conjugates a high-potency PI3K/PIKK inhibitor payload to a HER2 antibody and outlined preclinical characteristics including HER2-dependent activity and a bystander effect.

Looking ahead, management outlined several expected milestones over roughly the next 15 months, including Phase 3 results for the global SAFFRON study in mid-2026 and an NDA submission by year-end, top-line results from the CINOVA study in the second half of the year or early the following year, and the potential launch in 2026 for savolitinib in third-line gastric cancer. Dave also said the company expects three ATTC products to be in global clinical development during 2026.

During Q&A, management said it is seeking overseas development partners for sovleplenib and may pursue opportunities such as orphan drug designation to extend exclusivity and maximize overseas commercial value. On commercialization preparation in China, Yuan said the company expects to cover roughly 400 to 500 core target hospitals for hematology products and aims to build a specialized hematology sales team of about 100 representatives in the second half of the year.

Finally, management said it currently has no plans for share buybacks or dividends, and intends to prioritize cash deployment toward accelerating global ATTC R&D and evaluating in-licensing and M&A opportunities.

About HUTCHMED (NASDAQ:HCM)

HUTCHMED (NASDAQ: HCM) is a fully integrated biopharmaceutical company focused on discovering, developing, manufacturing and commercializing targeted therapies and immunotherapies for the treatment of cancer and other diseases. The company leverages in-house capabilities in small-molecule chemistry, biologics engineering and translational medicine to advance candidates through all stages of development. HUTCHMED’s integrated model encompasses early discovery research, clinical development, regulatory filings and commercial launches, enabling seamless progression from laboratory to market.

HUTCHMED’s commercial portfolio includes several in-market oncology therapies approved in China, including fruquintinib for metastatic colorectal cancer, surufatinib for neuroendocrine tumors and savolitinib for non-small cell lung cancer.

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