HUTCHMED Reports 2023 Interim Results and Provides Business Updates Strong execution on strategic direction, delivering near-term value while charting a path for growth, exemplified by global partnership with Takeda Reve

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HUTCHMED Reports 2023 Interim Results and

Provides Business Updates

Strong execution on strategic direction, delivering near-term value while charting a path for growth,

exemplified by global partnership with Takeda

Revenue grew 164% (173% CER) to US$533 million, with net income to HUTCHMED of US$169 million

(which include US$259 million of the upfront recognized from Takeda)

Company to Host Interim Results Call & Webcast Today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT

Company to host a Capital Markets Day in Q4 this year

Hong Kong, Shanghai & Florham Park, NJ Monday, July 31, 2023: HUTCHMED (China) Limited ( HUTCHMED , the Company or we ) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2023 and provides updates on key clinical and commercial developments.

All amounts are expressed in U.S. dollars unless otherwise stated.

Strategic: clinical, financial, and regulatory progress demonstrates strong delivery on the strategy

Product & pipeline: fruquintinib advancing to global launches, with continued progress across portfolio

Financial: HUTCHMED remains on track to become self-sustaining in 2025

2023 INTERIM RESULTS & BUSINESS UPDATES

Mr Simon To, Executive Chairman of HUTCHMED, said, The first half of 2023 has been successful for HUTCHMED. In late 2022, we announced our pipeline prioritization plan and intention to seek global partners to bring our medicines to help patients outside of China. Six months later, this strategy is already delivering significant results to our operations. We are successfully navigating the current challenging capital markets, while making significant progress towards our goal of becoming a self-sustaining, truly global biopharma company. Crucially, it means that we are well positioned to reach more patients than ever with our medicines.

In March, we closed a licensing deal for fruquintinib with Takeda and we are confident that they have the commitment, expertise, and commercial infrastructure to successfully roll out this innovative medicine to patients across the globe. The FDA Priority Review PDUFA date for fruquintinib is now set for November 30 this year, reflecting its potential to deliver significant improvement over currently available treatments.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, With the sharpening of our goals and priorities, we now have more resources to advance our assets and drive near-term value, and we are pleased to report on the important progress made so far this year. We have over 15 registration/registration-intent studies ongoing with seven drug candidates. Alongside this, our team has presented data at a number of leading medical conferences, including AACR14, ASCO15, ASCO GI16, EHA17 and ICML18, showcasing the productivity of our world class R&D engine. Furthermore, commercial performance has remained strong this year, with robust sales growth of our in-house developed oncology products in China. All three marketed medicines are now included on the NRDL, in line with our commitment to patient access. Moreover, our strategy means we are in a strong financial position as we look to continue developing our clinical programs. We started the second half of 2023 with $856 million in cash resources, including the $400 million received from Takeda.

HUTCHMED is now well placed for further successful product launches and life cycle extensions. In particular, we look forward to continuing the positive momentum with fruquintinib regulatory reviews around the world, and readouts from our registration studies for sovleplenib and amdizalisib later this year. As the last six months have shown, HUTCHMED clearly has the right strategy, leadership team, and vision to become a truly global biopharma, and I am confident that HUTCHMED will continue to deliver on this potential.

I. COMMERCIAL OPERATIONS

Total revenues increased 164% (173% at CER) to $532.9 million in the first half of 2023 (H1-22: $202.0m), driven by Oncology/Immunology partnering, its strong commercial progress in China, and growth in third-party distribution sales.

Oncology/Immunology consolidated revenues were up 294% (301% at CER) to $359.2 million (H1-22: $91.1m); driven by recognition of $258.7 million in partnering revenue for the upfront payment from Takeda, and our strong product sales growth resulting from in-market sales19 up 16% (25% at CER) to $101.3 million (H1-22: $87.4m);

* = For ELUNATE and ORPATHYS , represents total sales to third parties as provided by Lilly20 and AstraZeneca, respectively; and their sales to other third parties as invoiced by HUTCHMED.

** = For ELUNATE , represents manufacturing fees, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS represents manufacturing fees and royalties paid by AstraZeneca and sales to other third parties invoiced by HUTCHMED; for SULANDA and TAZVERIK , represents the Company's sales of the products to third parties.

II. REGULATORY UPDATES

III. CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS in China), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung, gastric and papillary renal cell carcinomas

Potential upcoming clinical and regulatory milestones for savolitinib:

Fruquintinib (ELUNATE in China), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability

Potential upcoming clinical and regulatory milestones for fruquintinib:

Surufatinib (SULANDA in China), an oral inhibitor of VEGFR, FGFR30 and CSF-1R31 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk32, an important component of the Fc receptor and B-cell receptor signaling pathway

Potential upcoming clinical milestones for sovleplenib:

Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3K 35 designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3K inhibitors

Potential upcoming clinical and regulatory milestones for amdizalisib:

Tazemetostat (TAZVERIK in Macau and the Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed from Ipsen36 subsidiary Epizyme37 in China

Potential upcoming clinical and regulatory milestones for tazemetostat:

HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

Earlier stage investigational drug candidates

In addition to the seven drug candidates being developed in over 15 registration studies above, HUTCHMED is developing six further oncology candidates in early-stage clinical trials. These are HMPL-306, a highly selective oral inhibitor of IDH1/238 designed to address resistance to currently marketed IDH inhibitors; HMPL-760, a highly selective, third-generation oral inhibitor of BTK39 with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes; HMPL-295, a highly selective oral inhibitor of ERK40 in the MAPK pathway41 with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK; HMPL-653, an oral, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations; HMPL-A83, a differentiated, red blood cell sparing anti-CD47 antibody; and HMPL-415, a novel SHP2 allosteric inhibitor that entered clinical trials in July 2023.

Subject to data and consultation with the CDE42, several of these earlier stage drug candidates have potential to move into registration trials in the next 12 months.

IV. COLLABORATION UPDATES

Closed Exclusive Worldwide License to Takeda for Fruquintinib Outside China

Further clinical progress by Inmagene with two candidates discovered by HUTCHMED

Other Ventures include our profitable prescription drug marketing and distribution platforms

VI. IMPACT OF COVID-19

While restrictive measures related to COVID-19 were gradually lifted in China starting from December 2022, COV D-19 had some impact on our research, clinical studies and our commercial activities in the first months of 2023. Measures were put in place to reduce the impact and, in the second quarter of 2023, these activities normalized.

At HUTCHMED, we are committed to a progressive journey as we continue to grow. This includes embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders, including our staff, our communities and our shareholders. In April 2023, we published our 2022 Sustainability Report alongside our 2022 Annual Report. This year we continue to make progress in line with the commitments and outcomes outlined in the report, including achieving satisfactory progress to date towards the 11 short- to long-term sustainability goals and targets and following the recommended disclosure framework of the Task Force on Climate-related Financial Disclosures (TCFD) in line with the risks assessment. In the second half of 2023, we continue enhancing our climate risks action by conducting scope 3 emissions screening, introducing a digital data collection platform, and further strengthening our sustainability-related disclosures.

FINANCIAL HIGHLIGHTS

Foreign exchange impact: The RMB depreciated against the U.S. dollar on average by approximately 7% during the six months ended June 30, 2023, which has impacted our consolidated financial results as highlighted below.

Cash, Cash Equivalents and Short-Term Investments were $856.2 million as of June 30, 2023 compared to $631.0 million as of December 31, 2022.

Revenues for the six months ended June 30, 2023 were $532.9 million compared to $202.0 million in the six months ended June 30, 2022.

Net Expenses for the six months ended June 30, 2023 were $364.3 million compared to $364.9 million for the six months ended June 30, 2022.

Net Income attributable to HUTCHMED for the six months ended June 30, 2023 was $168.6 million (which include $258.7 million of the upfront payment recognized from Takeda) compared to Net Loss attributable to HUTCHMED of $162.9 million for the six months ended June 30, 2022.

Condensed Consolidated Balance Sheets Data

Condensed Consolidated Statements of Operations Data

(Unaudited, in $'000, except share and per share data)

Following the closing of the license with Takeda and having received from them the upfront payment of $400 million, we currently expect to recognize approximately $280 million in 2023.

We provide financial guidance for Oncology/Immunology consolidated revenues, reflecting expected revenue growth of our oncology products in China; R&D services income from our partners AstraZeneca, Lilly and Takeda; potential milestone payments on fruquintinib U.S. regulatory approval; and the above-mentioned recognition of the upfront payment from Takeda. We believe that we remain on track to meet the 2023 guidance provided in the announcement of our 2022 full year results on February 28, 2023.

Shareholders and investors should note that:

Use of Non-GAAP Financial Measures and Reconciliation References in this announcement to adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the Use of Non-GAAP Financial Measures and Reconciliation below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

Conference call and audio webcast presentation scheduled today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT. After registering, investors may access a live audio webcast of the call via HUTCHMED's website at www.hutch-med.com/event/.

Participants who wish to join the call by telephone and ask a question must register. Upon registration, each participant will be provided with dial-in numbers and a unique PIN.

HUTCHMED intends to host a Capital Markets Day in the fourth quarter of this year to further update the market on its progress following the strategy change, and to showcase the exciting pipeline of drug candidates.

Unless the context requires otherwise, references in this announcement to the Group, the Company, HUTCHMED, HUTCHMED Group, we, us, and our, mean HUTCHMED (China) Limited and its subsidiaries unless otherwise stated or indicated by context.

Past Performance and Forward-Looking Statements

The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like will, expects, anticipates, future, intends, plans, believes, estimates, pipeline, could, potential, first-in-class, best-in-class, designed to, objective, guidance, pursue, or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, that any approvals which are obtained will be obtained at any particular time, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, HUTCHMED's Products ) will achieve any particular revenue or net income levels. In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally, including, among others, the risk that HUTCHMED's ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study's inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or the utilization, market acceptance and commercial success of HUTCHMED's Products after obtaining regulatory approval; competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED's Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED's Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED's Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED's Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries, uncertainties regarding future global exchange rates and uncertainties regarding the impact of COVID-19. For further discussion of these and other risks, see HUTCHMED's filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX46. HUTCHMED is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

In addition, this announcement contains statistical data and estimates that HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.

This announcement contains inside information for the purposes of Article 7 of Regulation (E.U.) No 596/2014 (as it forms part of retained E.U. law as defined in the European Union (Withdrawal) Act 2018).

We discover, develop, manufacture and market targeted therapies and immunotherapies for the treatment of cancer and immunological diseases through a fully integrated team of approximately 900 scientists and staff (December 31, 2022: ~960), and an in-house oncology commercial organization of over 900 staff (December 31, 2022: ~870).

We have 13 oncology drug candidates in clinical trials in China, with four also in active clinical development in the U.S. and Europe. Our three medicines, fruquintinib, surufatinib and savolitinib, have all been approved and launched in China and the fourth, tazemetostat, has been approved and launched in Hainan Pilot Zone and Macau, and submitted for registration in Hong Kong.

MARKETED PRODUCT SALES

Despite some initial challenges in the first quarter of the year due to the impact of COVID-19 in China, in-market sales of HUTCHMED's novel oncology products continued to grow at 16% (25% at CER) to $101.3 million (H1-22: $87.4m) in the first half of 2023.

Fruquintinib (ELUNATE in China)

ELUNATE is approved for the treatment of third-line metastatic CRC for which there is an approximate incidence of 105,000 new patients per year in China. We estimate that in the first half of 2023, approximately 17,000 (H1 2022: approximately 14,000) new patients were treated with ELUNATE in China, despite some challenges in the first quarter of the year due to the impact of COVID-19. ELUNATE surpassed regorafenib in prescription numbers for late-stage CRC at the end of 2021, and that lead grew to an approximately 47% market share at the end of June 2023. This resulted in in-market sales of $56.3 million, up 12% (20% at CER) versus the first half of 2022 ($50.4 million).

Under the terms of our agreement with Lilly, HUTCHMED manages all on-the-ground medical detailing, promotion and local and regional marketing activities for ELUNATE in China. We consolidate as revenues approximately 70-80% of ELUNATE in-market sales from manufacturing fees, service fees and royalties paid to us by Lilly. In the first half of 2023, we consolidated $42.0 million in revenue for ELUNATE , equal to 75% of in-market sales. Our commercial team continues to be highly active, celebrating ELUNATE 's fifth year since it was approved and adding a further 112 (+17%) new hospital pharmacy listings in the first half of 2023.

ELUNATE continues to be included in the NRDL in 2023. Negotiations with the China NHSA47 to renew its inclusion beyond 2023 are expected to take place in the second half of this year. The new NHSA NRDL price determination scheme was published in July 2023, indicating medicines that already have reimbursement coverage will go through a simplified renewal/renegotiation process with limited further price discount, particularly for products that have been reimbursed for at least four years, such as ELUNATE .

Outside of China, fruquintinib will be marketed by our partner Takeda. In the U.S., commercial preparations are ongoing by Takeda to be ready for launch once U.S. approval is granted.

Surufatinib (SULANDA in China)

SULANDA was launched in China in 2021 for the treatment of all advanced NETs48 for which there is an approximate incidence of 34,000 new patients per year in China. In the first half of 2023, approximately 12,000 new patients were treated with SULANDA , compared to the approximately 12,000 new patients in 2022. The two older therapies for advanced NETs approved and NRDL reimbursed in China, SUTENT and AFINITOR , were approved in 2012 and 2014, respectively. In the first quarter of 2023, SULANDA had the leading share of the market at approximately 17%, compared to SUTENT and AFINITOR at 13% and 11%, respectively.

Sales growth in 2022 was strong, being the first year in which SULANDA had been listed on the NRDL. As a result of our continued marketing activities, increasing patient access to SULANDA and its long duration of treatment, total sales in the first half of 2023 accelerated, growing by 66% (79% at CER) to $22.6 million (H1-22: $13.6 million). Our commercial team added a further 103 (+19%) new hospital pharmacy listings in the first half of 2023.

Savolitinib (ORPATHYS in China)

ORPATHYS is the first-in-class selective MET inhibitor to be approved in China, launched and marketed by our partner, AstraZeneca for patients with MET exon 14 skipping alteration NSCLC. More than a third of the world's lung cancer patients are in China. Among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.

In 2021, 2022 and the first two months of 2023, ORPATHYS was sold as a self-pay drug. Following negotiations with the China NHSA in January 2023, ORPATHYS has been included in the updated NRDL since March 1, 2023 at a 38% discount relative to the self-pay price, broadening patient access to this medicine. Sales during the first half of 2023 were impacted by customary channel fluctuations following the announcement (in January 2023) and implementation of the NRDL listing (in March 2023), with increased volume in the latter part of the first half of 2023. In-market sales for ORPATHYS fell 5% (increased 2% at CER) in the first half of 2023 to $22.0 million (H1-22: $23.3m) resulting in our consolidation of $15.1 million (H1-22: $13.8m) in revenues from manufacturing fees and royalties. Sales in the second quarter of 2023 were substantially higher than in the second quarter of 2022 before NRDL listing, increasing 84% by volume.

Market understanding of the need for MET testing has improved significantly, with approximately half of new advanced/relapsed NSCLC patients in China being tested. In the National Health Commission's Treatment Guidelines for Primary Lung Cancer 2022 and the China Medical Association Oncology Committee Lung Cancer Group's China Medical Association Guideline for Clinical Diagnosis and Treatment of Lung Cancer, ORPATHYS was identified as the only targeted therapy recommended for MET exon 14 patients, while a similar guideline from CSCO49 also recommended ORPATHYS as the standard of care for such patients. As MET testing awareness and access increases, more patients are expected to be prescribed a selective MET inhibitor.

ORPATHYS is the first selective MET inhibitor on the market in China, representing the majority MET TKI50 sales. Several selective MET inhibitors are in development in China, but only one is currently expected to be eligible to enter NRDL negotiations in late 2023.

In March 2023, ORPATHYS was approved in the Macau Special Administrative Region.

Tazemetostat (TAZVERIK in Hainan and Macau, China; the U.S. and Japan)

In May 2022, tazemetostat was approved by the Health Commission and Medical Products Administration of Hainan Province to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone), under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with epithelioid sarcoma and follicular lymphoma consistent with the label as approved by the FDA. Launched in 2013 and located in China, the Hainan Pilot Zone is a destination for international medical tourism and global hub for scientific innovation, welcoming 83,900 medical tourists in 2020, according to official data. Tazemetostat was included in the 2022 CSCO guidelines for epithelioid sarcoma. 10 epithelioid sarcoma patients began treatment in the first half of 2023 (H1-22: none). Tazemetostat is included in 2023 CSCO guideline for follicular lymphoma.

In March 2023, tazemetostat was approved in the Macau Special Administrative Region. A market authorization application has been under review in Hong Kong since December 2022.

RESEARCH & DEVELOPMENT

Our strategy is aimed at accelerating our path to profitability and establishing a long-term sustainable business, by prioritizing late-stage and registrational studies in China and partnering outside of China. Selected out-licensing opportunity candidates, particularly outside of China, include sovleplenib, surufatinib and HMPL-306. HUTCHMED intends to continue to run early phase development programs for selected drug candidates in U.S., E.U. and Japan where we believe we can differentiate from a global perspective.

Below is a summary update of the clinical trial progress of our investigational drug candidates. For more details about each trial, please refer to our 2022 Annual Report published in April 2023 and recent scientific publications.

Savolitinib (ORPATHYS in China)

Savolitinib is an oral, potent, and highly selective oral inhibitor of MET. In global partnership with AstraZeneca, savolitinib is being studied in NSCLC, PRCC and gastric cancer clinical trials with about 2,000 patients to date, both as a monotherapy and in combinations. AstraZeneca has paid HUTCHMED $85 million of the total $140 million in upfront payments, development and approvals milestones that are potentially payable under the relevant license and collaboration agreement.