Chondrosarcoma

SAN DIEGO, Feb. 28, 2024 /PRNewswire/ -- Inhibrx, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company"), a biopharmaceutical company with three clinical programs in development and a strong emerging pipeline, today reported financial results for the fourth quarter and fiscal year 2023. Key Highlights Sale of INBRX-101 to Sanofi: In January 2024, the Company announced that it entered into a definitive agreement with Aventis, Inc. ("Aventis"), a subsidiary of Sanofi, whereby Sanofi will indirectly acquire, through Aventis, all of the assets and liabilities associated with INBRX-101 ("the Merger"). Immediately prior to the closing of the Merger, all non-101 assets and liabilities will be spun out into a new publicly traded company, Inhibrx Biosciences, Inc. ("New Inhibrx"). Sanofi will acquire all outstanding shares of the Company and, in turn, each shareholder will receive (i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone, and (iii) one SEC-registered, publicly-traded, share of New Inhibrx per every four shares of Inhibrx common stock held. In addition, in connection with the transaction, Sanofi will assume and retire the Company's outstanding third-party debt and fund New Inhibrx with $200.0 million in cash. Sanofi will also retain an equity interest in New Inhibrx of 8%. The Company expects the transaction to close in the second quarter of 2024. INBRX-105: The Company decided to terminate its INBRX-105 program after evaluation of the totality of data from the expansion cohorts, in which it determined the initial signal was not sufficiently validated to support the continuation of the program. The Company is in the process of winding down the clinical trial and expects it to be completed within the first half of 2024. All Company Employees and Directors are Currently Subject to a Company-wide Blackout Restricting the Trading of Inhibrx Stock: The Company plans to file the proxy statement related to the sale of INBRX-101 in the next few days. Shortly after public filing of the Company's proxy statement, and in accordance with the Company's insider trading policy, the Company expects to lift the Company-wide blackout. As of today, employees and board members hold approximately 3.5 million vested and in-the-money options in Inhibrx common stock. The shares issuable upon exercise of these options are generally freely tradable. Any in-the-money options still outstanding at the Merger close will be converted into the Merger Consideration, as defined in the Merger Agreement, and will not convert into New Inhibrx shares. Financial Results Cash and Cash Equivalents. As of December 31, 2023, Inhibrx had cash and cash equivalents of $277.9 million, compared to $337.3 million as of September 30, 2023. R&D Expense. Research and development expenses were $82.1 million during the fourth quarter of 2023 as compared to $30.5 million during the fourth quarter of 2022. Research and development expenses were $191.6 million during the fiscal year 2023 as compared to $110.2 million during the fiscal year 2022. The increase in research and development expenses during both periods was primarily due to the following factors: an increase in contract manufacturing expenses due to the nature of the development and manufacturing activities performed during the current period at our CDMO and CRO partners supporting our clinical and preclinical therapeutic candidates, primarily due to large scale drug substance manufacturing services, including the utilization of raw materials during the fourth quarter of 2023, performed by one of our CDMO partners for INBRX-101, in addition to other activities performed with our CDMO partners which reflect the stage-specific needs of each of our programs, including early and late stage drug substance clinical manufacturing, drug product manufacturing, and selected BLA-enabling activities; an increase in clinical trial expenses, primarily related to costs incurred following the initiation of the registration-enabling Phase 2 trial for INBRX-101 for the treatment of emphysema due to AATD, which was initiated during the current year, as well as the progression of the Company's INBRX-109 registration-enabling Phase 2 trial for the treatment of unresectable or metastatic conventional chondrosarcoma. The Company also incurred increased costs associated with the utilization of Keytruda used in combination with INBRX-105 in our Phase 1/2 clinical trial; and an increase in personnel-related costs, primarily related to an increase in headcount as a result of a significant expansion of the Company's clinical team, as well as the issuance of additional stock options and the expansion of the bonus eligibility pool during the current year. G&A Expense. General and administrative expenses were $7.8 million during the fourth quarter of 2023, compared to $5.3 million during the fourth quarter of 2022. General and administrative expenses were $29.4 million during the fiscal year 2023, compared to $21.1 million during the fiscal year 2022. This increase in general and administrative expenses during both periods was primarily due to the following factors: an increase in personnel-related costs, primarily related to an increase in headcount as the Company continues to build its commercial strategy and medical affairs team, as well as increased expense related to additional stock option grants to employees and the expansion of the bonus eligibility pool in the current year; an increase in pre-commercialization expenses, primarily related to increases in consulting services to support the Company's commercial operations business intelligence strategies and market research expenses related to INBRX-101 and INBRX-109; and an increase in professional service expenses related to accounting and legal services which support the Company in its general corporate and intellectual property matters, including services performed during the fourth quarter of 2023 as related to the Company's proposed Merger. Net Loss. Net loss was $93.6 million during the fourth quarter of 2023, or $1.73 per share, compared to $40.9 million during the fourth quarter of 2022, or $0.95 per share. Net loss was $241.4 million during the fiscal year 2023, or $5.12 per share, compared to $145.2 million during the fiscal year 2022, or $3.62 per share. About Inhibrx, Inc. Inhibrx is a clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates in oncology and orphan diseases. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding: the closing of the Merger in the anticipated timeframe or at all; the potential benefits or payments in connection with the Merger; the ability to realize the anticipated benefits of the proposed Merger; the anticipated timing to wind down the INBRX-105 program; Inhibrx's and its investigators' judgments and beliefs regarding the strength of Inhibrx's pipeline and the observed safety and efficacy to date of its therapeutic candidates; whether a trial is registration-enabling; future clinical development of Inhibrx's therapeutic candidates, including any potential for approval or accelerated approval or implication that the results of earlier clinical trials or studies will be representative of later clinical trials. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals and failure to obtain the requisite vote by the Company's shareholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the integration of the Company and Sanofi will be more difficult, time consuming or costly than expected; risks and costs relating to the separation of the assets and liabilities associated with INBRX-105, INBRX-106 and INBRX-109 and the consummation of the spin-off in the anticipated timeframe or at all; changes to the configuration of the INBRX-105, INBRX-106 and INBRX-109 businesses included in the separation if implemented; disruption from the transaction making it more difficult to maintain business and operational relationships; risks related to diverting management's attention from the Company's ongoing business operation; negative effects of this announcement or the consummation of the proposed transaction on the market price of the Company's shares of common stock and/or operating results; significant transaction costs; risks associated with the discovery of unknown liabilities prior to or after the closing of the proposed transactions; the risk of litigation and/or regulatory actions related to the proposed transactions or the Company's business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; the conflicts in the Ukraine and the Middle East; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; and future business combinations or disposals. Important factors, risks and uncertainties that could cause actual results to differ materially from such forward looking statements also include but are not limited to the initiation, timing, progress and results of the Company's research and development programs as well as the Company's preclinical studies and clinical trials; the Company's ability to advance therapeutic candidates into, and successfully complete, clinical trials; the Company's interpretation of initial, interim or preliminary data from the Company's clinical trials, including interpretations regarding disease control and disease response; the timing or likelihood of regulatory filings and approvals, including whether any product candidate, receives approval from the FDA, or similar regulatory authority, for an accelerated approval process; the commercialization of the Company's therapeutic candidates, if approved; the pricing, coverage and reimbursement of the Company's therapeutic candidates, if approved; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the Company's ability to successfully manufacture the Company's therapeutic candidates for clinical trials and commercial use, if approved; the Company's ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the Company's ability to enter into strategic partnerships and the potential benefits of such partnerships; the Company's estimates regarding expenses, capital requirements and needs for additional financing; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; the Company's and the Company's third party partners' and service providers' ability to continue operations and advance the Company's therapeutic candidates through clinical trials and the ability of the Company's third party manufacturers to provide the required raw materials, antibodies and other biologics for the Company's preclinical research and clinical trials in light of current market conditions or any pandemics, regional conflicts, sanctions, labor conditions, geopolitical events, natural disasters or extreme weather events; the ability to retain the continued service of the Company's key professionals and to identify, hire and retain additional qualified professionals; and developments relating to the Company's competitors and the Company's industry; and other risks described from time to time in the "Risk Factors" section of its filings with the U.S. Securities and Exchange Commission, including those described in its Annual Report on Form 10-K as well as its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Additional Information and Where to Find It In connection with the proposed acquisition, the Company will be filing documents with the SEC, including preliminary and definitive proxy statements relating to the proposed acquisition. The definitive proxy statement will be mailed to the Company's shareholders in connection with the proposed acquisition. This communication is not a substitute for the proxy statement or any other document that may be filed by the Company with the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED ACQUISITION OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED ACQUISITION. Any vote in respect of resolutions to be proposed at the Company's shareholder meeting to approve the proposed acquisition or other responses in relation to the proposed acquisition should be made only on the basis of the information contained in the Company's proxy statement. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC's web site at or on the Company's website at . No Offer or Solicitation This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. Participants in Solicitation The Company, its respective directors and certain of their respective executive officers may be deemed to be "participants" (as defined under Section 14(a) of the Securities Exchange Act of 1934) in the solicitation of proxies from shareholders of the Company with respect to the potential transaction. Information about the identity of Company's (i) directors is set forth in the section entitled "Our Board of Directors" on page 11 of Company's proxy statement on Schedule 14A filed with the SEC on April 13, 2023 (the "2023 Proxy") (and available here) and (ii) executive officers is set forth in the section entitled "Our Executive Officers" on page 14 of the 2023 Proxy (and available here). Information about the compensation of Company's non-employee directors is set forth in the section entitled "Non-Employee Director Compensation Policy" starting on page 16 of the 2023 Proxy (and available here). Information about the compensation of Company's named executive officers is set forth in the section entitled "Executive Compensation" starting on page 18 of the 2023 Proxy (and available here). Transactions with related persons (as defined in Item 404 of Regulation S-K promulgated under the Securities Act of 1933) are disclosed in the section entitled "Certain Relationships and Related Party Transactions" on page 31 of the 2023 Proxy (and available here). Information about the beneficial ownership of Company securities by Company's directors and named executive officers is set forth in the section entitled "Security Ownership of Certain Beneficial Owners and Management" starting on page 28 of the 2023 Proxy (and available here). Any change of the holdings of the Company's securities by its directors or executive officers from the amounts set forth in the 2023 Proxy have been reflected in the following Statements of Beneficial Ownership on Form 4 filed with the SEC: Form 4, filed by Jon Faiz Kayyem, with the filing of the Company on May 30, 2023; Form 4, filed by Kimberly Manhard, with the filing of the Company on May 30, 2023; Form 4, filed by Kristiina Vuori MD, with the filing of the Company on May 30, 2023; and Form 4, filed by Douglas Forsyth, with the filing of the Company on May 30, 2023. As of February 27, 2024, each of the "participants" set forth below "beneficially owned" (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934) less than 1% of shares of common stock, par value $0.0001 share, of the Company. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the definitive proxy statement relating to the proposed acquisition when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC's website at and the Company's website at . Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx, Inc.

Revenue grew 97% (102% CER) to US$838 million, with net income of US$101 million First U.S. FDA approval of our self-developed medicine, FRUZAQLA™ (fruquintinib) Sovleplenib for ITP accepted for NDA review in China, with Priority Review status and Breakthrough Therapy designation HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024. All amounts are expressed in U.S. dollars unless otherwise stated. Strategic: global vision, commitment to patients and path to self-sustainability Executed our global vision of bringing our innovative medicines worldwide, as demonstrated through the Takeda1 partnership which brought $435 million in upfront and milestone payments plus manufacturing income and royalties on net sales, setting a strategic example for the rest of our pipeline.On track to be self-sustaining with a disciplined approach to leveraging our R&D2 expertise and creating value through licensing and commercialization. Pipeline: fruquintinib global and China expansion, sovleplenib China NDA3 review, savolitinib NSCLC4 enrolled Fruquintinib U.S. FDA5 approval three weeks ahead of PDUFA6 date for third-line CRC7, leading to a swift launch by Takeda, inclusion in NCCN8 guidelines and U.S. in-market sales9 of $15.1 million. Global regulatory progress with MAA10 filing to the EMA11 validated in June 2023 and NDA submitted to PMDA12 in September 2023.Fruquintinib NDA for second-line gastric cancer accepted for review in China. Registrations studies in China for 2L EMC13 and 2L RCC14 completed enrollment during 2023 for fruquintinib in combination with sintilimab, expecting NDA filing to the NMPA15 for EMC in early 2024 and topline results for RCC by end of 2024.NDA for sovleplenib, a novel Syk16 inhibitor, for primary ITP17 accepted and granted priority review in China, supported by data from Phase III trial (ESLIM-01), meeting all endpoints.SAVANNAH, the pivotal global Phase II trial for savolitinib in NSCLC, completed enrollment, to be followed by potential NDA filing to the U.S. FDA by AstraZeneca18 around the end of 2024. Outlook and financial: expecting strong product revenue growth and reduced expenses; substantial cash Total revenue up 97% (102% at CER19) to $838.0 million for 2023, with Oncology/​Immunology consolidated revenue up 223% (228% at CER) to $528.6 million at high end of guidance, including recognition of $280 million of the upfront payment from Takeda. Net income attributable to HUTCHMED of $100.8 million.2024 Oncology/Immunology consolidated revenue guidance of $300 million to $400 million, driven by 30% to 50% growth target in marketed product sales and royalties.R&D expenses focused in line with strategy targeting key projects.Strengthened cash balance, with $886.3 million at year end (2022: $631.0m), ensures HUTCHMED is well placed to deliver on its objective of becoming a self-sustaining business. 2023 FULL YEAR RESULTS & BUSINESS UPDATES Mr Simon To, Executive Chairman of HUTCHMED, said, “We have made significant progress throughout 2023. We executed against our commitment to bring our innovative medicines to patients worldwide with the U.S. FDA approval of FRUZAQLA™ in November 2023, while remaining dedicated to becoming a self-sustaining business. The Takeda partnership, which is one of the biggest small-molecule overseas licensing deals in the history of China biotech, strengthened our cash position by $435 million. Takeda delivered a successful U.S. launch within 48 hours of approval, and has subsequently seen strong early patient uptake.” “We will continue to deliver on our strategy in 2024. We will stay focused on our target of becoming sustainable through our balanced strategy of growing sales of our novel medicines in China, and advancing our medicines overseas with our partners. This, when combined with our other goals on pipeline progression and further business development, means that while the global macroeconomic environment remains uncertain, HUTCHMED is positioned to thrive and continue to deliver innovative medicines to ever more patients around the world.” Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “HUTCHMED delivered impressive financial results in 2023, with revenue up 97% to $838 million. This, alongside our significantly strengthened cash balance of $886 million, will enable us to continue advancing our pipeline and successfully executing our strategy.” “2023 was an important year for HUTCHMED, particularly for fruquintinib, for which we filed market authorization applications in the U.S., EU and Japan, based on the successful FRESCO-2 study. Following the U.S. FDA approval for third-line patients with advanced CRC, we continue to work together with Takeda to pursue additional launches in new markets worldwide. In China, we also filed an NDA for second-line gastric cancer based on the FRUTIGA study.” “Another milestone was the successful ESLIM-01 registration study in China in ITP patients for sovleplenib, our first potential novel medicine in immunological diseases. The NDA was accepted and granted priority review by the NMPA in January 2024. There are over 250,000 new and existing adult ITP patients in China20. The treatment options are limited to steroids and TPO/TPO-RAs21, representing an unmet medical need that sovleplenib could help address, with its new mechanism of action and favorable safety profile. Syk inhibition has the potential to target other major diseases such as rheumatoid arthritis. We are also planning to initiate clinical development of sovleplenib outside China in 2024.” “For savolitinib, we completed the confirmatory trial in NSCLC patients with MET22 exon 14 skipping alterations. An NDA submission is expected in the first quarter of 2024, with potential to expand the label indication to include first-line patients in China. Outside China, we will continue our work with AstraZeneca on the pivotal global savolitinib lung cancer trial SAVANNAH, which, subject to favorable data, can support a filing to the U.S. FDA for approval. This study completed enrollment with a potential NDA submission towards the end of 2024 in EGFR23 mutant NSCLC patients who progressed on TAGRISSO® treatment, which received U.S. FDA Fast Track designation in January 2023. We believe the convenient dosing, targeted efficacy and safety profile of savolitinib as an oral medicine in combination with TAGRISSO®, the leading oral third-generation EGFR TKI24, should position it well in a competitive market and address the unmet needs of MET+ NSCLC patients.” "Our China commercialization efforts progressed well, as we successfully renewed NRDL25 coverage for both fruquintinib and surufatinib without further price reduction. Their in-market sales saw strong growth in 2023. Over the next two years, we plan to continue growth in China through expanded indications and the launch of new products together with revenue from FRUZAQLA™ overseas commercialization.” I. COMMERCIAL OPERATIONS Total revenue increased 97% (102% at CER) to $838.0 million in 2023 (2022: $426.4m), driven by the Takeda partnership, our strong commercial progress in China, and growth in third-party distribution sales, resulting in a net income of $101 million for 2023. Oncology/Immunology consolidated revenue were up 223% (228% at CER) to $528.6 million (2022: $163.8m); towards the high end of our guidance, driven by recognition of $280.0 million in partnering revenue for the upfront payment, $32.0 million for U.S. FDA approval milestone payments from Takeda, and our strong product sales growth resulting from in-market sales up 28% (35% at CER) to $213.6 million (2022: $167.1m); ELUNATE® (fruquintinib China) in-market sales in 2023 increased 15% (22% at CER) to $107.5 million (2022: $93.5m), reflecting its continued lead in market share;FRUZAQLA™ (fruquintinib U.S.) in-market sales in 2023 were $15.1 million, reflecting its U.S. launch in November 2023;SULANDA® (surufatinib) in-market sales in 2023 increased 36% (43% at CER) to $43.9 million (2022: $32.3m), reflecting its growing market share after two years on the NRDL;ORPATHYS® (savolitinib) in-market sales in 2023 increased 12% (19% at CER) to $46.1 million (2022: $41.2m). Sales in the first quarter were impacted by customary channel fluctuations ahead of its NRDL inclusion on March 1, with the subsequent three quarters of 2023 up 30% compared to the same period in 2022;R&D services income up 116% (119% at CER) to $52.4 million (2022: $24.2m), now also including fees from our new partner Takeda for the management of regulatory activities;Takeda upfront payment of $400.0 million received, of which $280.0 million recognized in revenue during 2023, with the remainder to be recognized when services and performance obligations are completed; andSuccessful management of commercial operations to expand coverage of oncology hospitals and physicians, despite challenges from COVID-19-related disruptions around the start of the year, and from an anti-corruption crackdown of the healthcare sector in China in the second half of 2023. Hospital access and related activities became more restricted, but improved starting in October 2023. $’millionsIn-market Sales*Consolidated Revenue** 20232022%Δ(CER) 20232022%Δ(CER)ELUNATE®$107.5$93.5+15%(+22%)$83.2$69.9+19%(+26%)FRUZAQLA™$15.1– –$7.2– –SULANDA®$43.9$32.3+36%(+43%)$43.9$32.3+36%(+43%)ORPATHYS®$46.1$41.2+12%(+19%)$28.9$22.3+30%(+37%)TAZVERIK®$1.0$0.1>700% $1.0$0.1>700% Products Revenue$213.6$167.1+28%(+35%)$164.2$124.6+32%(+39%)Other R&D services income $52.4$24.2+116%(+119%)Upfront and milestone income $312.0$15.0 Total Oncology/​Immunology $528.6$163.8+223%(+228%)Other Ventures $309.4$262.6+18%(+24%)Total revenue $838.0$426.4+97%(+102%)* = For ELUNATE®, FRUZAQLA™ and ORPATHYS®, mainly represents total sales to third parties as provided by Lilly26, Takeda and AstraZeneca, respectively.** = For ELUNATE®, represents drug product supply, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for FRUZAQLA™, represents drug product supply and royalties paid by Takeda; for ORPATHYS®, represents drug product supply 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 China Fruquintinib NDA accepted in combination with paclitaxel for second-line gastric cancer in April 2023;Sovleplenib NDA accepted for primary ITP in January 2024, after receiving priority review status in 2023;Fruquintinib received Breakthrough Therapy designation in combination with sintilimab for second-line endometrial cancer in July 2023;Fruquintinib received Hong Kong approval for third-line CRC in January 2024; andORPATHYS® (savolitinib) and TAZVERIK® (tazemetostat) received Macau approvals in March 2023. Ex-China Fruquintinib U.S. FDA approved in November 2023 for previously treated metastatic CRC, after the NDA was granted priority review in May 2023;Fruquintinib NDA submitted to the Japanese PMDA in September 2023;Fruquintinib MAA submission to the EMA validated in June 2023; andSavolitinib, in combination with TAGRISSO®, designated a U.S. FDA Fast Track program in January 2023 for the treatment of patients with NSCLC with MET overexpression and/or amplification, and who have had disease progression during or following prior TAGRISSO®. III. LATE-STAGE 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 Completed enrollment of a pivotal global Phase II study SAVANNAH (NCT03778229) for NSCLC patients who have progressed following TAGRISSO® due to MET amplification or overexpression designated as a Fast Track development program by the U.S. FDA, with the possibility of accelerated approval. Continued enrolling SAFFRON (NCT05261399), a global, pivotal Phase III study of the TAGRISSO® combination supporting SAVANNAH;Reported positive results from the confirmatory China Phase IIIb study (NCT04923945) first-line cohort in MET exon 14 skipping alteration NSCLC; completed enrollment in a second-line cohort; andInitiated the registration stage of a China Phase II study in third-line gastric cancer patients with MET amplification (NCT04923932).Potential upcoming clinical and regulatory milestones for savolitinib: Submit China NDA for first-line and second-line MET exon 14 skipping alteration NSCLC in early-2024;Complete enrollment of SACHI (NCT05015608), a pivotal Phase III study of the TAGRISSO® combination in China for NSCLC patients with MET amplification following progression on EGFR inhibitor treatment in late 2024;Complete enrollment of SANOVO (NCT05009836), a pivotal Phase III study of the TAGRISSO® combination in China in first-line NSCLC patients with EGFR mutation & MET overexpression in late 2024; andEngage U.S. FDA regarding possible NDA filing on SAVANNAH, subject to positive results, around year end 2024. Fruquintinib (ELUNATE® in China, FRUZAQLA™ in the U.S.), a highly selective oral inhibitor of VEGFR27 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of a combination therapy Presented FRUTIGA (NCT03223376) results at ASCO28 Plenary in February 2024 in second-line gastric cancer patients on fruquintinib plus paclitaxel. PFS29, ORR30 and DCR31 endpoints showed statistically significant improvements. Although OS32 improvement was not statistically significant overall, it was statistically significant in a pre-specified analysis excluding patients taking subsequent antitumor therapy;Completed enrollment of FRUSICA-1 (NCT03903705), a China endometrial cancer registration cohort of a Phase II study of fruquintinib in combination with PD-133 antibody sintilimab in July 2023;Completed enrollment of FRUSICA-2 (NCT05522231), a China Phase II/III study of fruquintinib in combination with PD-1 antibody sintilimab in clear cell RCC in December 2023;Updated results from the clear cell RCC cohort of a China Phase II study on fruquintinib in combination with PD-1 antibody sintilimab at ASCO 2023 (NCT03903705); andPublished in peer-reviewed journal The Lancet positive results of the global Phase III FRESCO-2 registration trial (NCT04322539) in previously treated metastatic CRC patients in June 2023.Potential upcoming clinical and regulatory milestones for fruquintinib: Completion of EMA MAA review for previously-treated metastatic CRC in mid-2024;Completion of PMDA NDA review for previously-treated metastatic CRC in late-2024;Registration filing to the NMPA for second-line endometrial cancer in early 2024; andTop-line results from Phase II/III registration trial in clear cell RCC around year end 2024. Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR34 and CSF-1R35 designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation Reported data from the Phase Ib/II China toripalimab (PD-1 antibody) combination study at the 2023 AACR36 and ASCO annual meetings (NCT04169672); andReported encouraging early results at ASCO 2023 of an investigator-initiated trial of surufatinib in combination with a PD-1 antibody and chemotherapy in first-line treatment for pancreatic ductal adenocarcinoma. Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathway Met primary endpoint and all secondary endpoints for a pivotal Phase III study (NCT05029635) in adult patients with primary ITP in China; andMet primary endpoint for a Phase II Proof-of-Concept study in warm AIHA37 in China (NCT05535933) with Phase III registration study being planned.Potential upcoming clinical milestones for sovleplenib: Submit ESLIM-01 results for publication and/or presentation in mid-2024; andInitiate a dose-finding study in ITP in the U.S./EU in mid-2024. Tazemetostat (TAZVERIK® in Macau and the China Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed from Ipsen38 Completed recruitment of a China bridging study in follicular lymphoma for conditional registration based on U.S. approvals in September 2023 (NCT05467943);Approved and launched in the Macau Special Administrative Region in March 2023; andPublished promising results from the Phase Ib portion of SYMPHONY-1, a global Phase 1b/III combination study in relapsed/refractory follicular lymphoma patients after at least two prior therapies (NCT04224493). ORR was 90.9%, and in the recommended Phase III dose cohort, 18-month PFS and DoR39 estimates were 94.4% and 100% with no dose-limiting toxicities.Potential upcoming clinical and regulatory milestones for tazemetostat: China NDA filing for relapsed/refractory 3L+ follicular lymphoma expected in mid-2024. HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3 Reported human data for the first time at the 2023 ASCO annual meeting; andAfter consultation with NMPA, initiated the registration phase of the ongoing Phase II trial for IHCC40 patients with FGFR 2 fusion (NCT04353375). Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ41 designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors Met primary endpoint of ORR in the follicular lymphoma cohort of a China registration Phase II study with Breakthrough Therapy designation (NCT04849351). However, in recent discussions with China NMPA, it is clear that a randomized study is now required to support registration. In view of the changing regulatory requirement, we are currently evaluating the clinical development plan and regulatory guidance before deciding the regulatory strategy for this indication. IV. COLLABORATION UPDATES Closed Exclusive Worldwide License to Takeda for Fruquintinib Outside China Takeda is responsible for development, manufacturing and commercialization in all indications and territories outside of mainland China, Hong Kong and Macau; andHUTCHMED is eligible to receive up to $1.13 billion, including the $400 million upfront received in April 2023, and up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, of which a $35 million milestone payment was received in December 2023 after the approval by the U.S. FDA, as well as manufacturing income and royalties on net sales. Further clinical progress by Inmagene42 with two candidates discovered by HUTCHMED Inmagene initiated two global Phase IIa trials with IMG-007, an anti-OX40 antibody, in adults with moderate-to-severe atopic dermatitis and in adults with alopecia areata. It was safe and well-tolerated in the completed Phase I study with no reports of pyrexia or chills, which are common adverse events of rocatinlimab, another anti-OX40 treatment;Inmagene completed a Phase I study with IMG-004, a reversible, non-covalent, highly selective oral BTK43 inhibitor designed to target immunological diseases. IMG-004 was safe and well-tolerated in this single-ascending-dose study, with a long half-life and sustained pharmacodynamic effects that are well above others in its class; andInmagene exercised options for an exclusive license to further develop, manufacture and commercialize these two drug candidates worldwide subject to completion of a share subscription agreement signed in February 2024 for approximately 7.5% of Inmagene shares (fully diluted). V. OTHER VENTURES Other Ventures include our profitable prescription drug marketing and distribution platforms Consolidated revenue increased by 18% (24% at CER) to $309.4 million (2022: $262.6m);SHPL44 non-consolidated joint venture revenue increased by 4% (10% at CER) to $385.5 million (2022: $370.6m);Consolidated net income attributable to HUTCHMED from our Other Ventures decreased by 8% (3% at CER) to $50.3 million (2022: $54.6m), which was primarily due to decrease on the net income contributed from SHPL of $47.4 million (2022: $49.9m) resulting from the impact of gradual price adjustment from volume-based procurement;Disposed interests in HHOHK45 and HSN46 for $5.1 million; andWe continue to explore opportunities to monetize the underlying value of our SHPL joint venture including various divestment and equity capital market alternatives. VI. SUSTAINABILITY HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In 2023, we continued to make progress, including: Satisfactory progress made in 11 short- to long-term goals and targets; sustainability performance on goals and targets continued to be incorporated into management’s performance-based remuneration;Enhanced climate actions by conducting Scope 3 emissions screening and measurement, and engaging with suppliers to gradually implement sustainability initiatives collaboratively. Following the climate risk assessment in 2022, regular monitoring and reviews on climate risks and opportunities have been undertaken; our climate actions continue to be disclosed in alignment with the recommendations of the Task Force on Climate-related Financial Disclosures (TCFD);Enhanced data quality by introducing a digital data collection platform to streamline collecting, managing, and reporting data, ensuring improved data reliability, comparability and transparency;Strengthened alignment in the five key sustainability pillars which encompassed the most relevant and material sustainability topics for HUTCHMED, including (i) climate action; (ii) access to healthcare; (iii) human capital; (iv) ethics and transparency; and (v) innovation;Marked improvements shown in major ESG ratings and awards, reflecting wider recognition of HUTCHMED’s efforts in sustainability; andEnhanced disclosure by referencing the latest sustainability disclosure standards and sector specific disclosure standards ahead of requirement. These efforts will continue to guide HUTCHMED towards a more sustainable future. The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance. VII. IMPACT OF COVID-19 While restrictive measures related to COVID-19 were gradually lifted in China starting from December 2022, COVꞮD-19 had some impact on our research, clinical studies and our commercial activities in the first few months of 2023. Measures were put in place to reduce the impact and, in the second quarter of 2023, these activities normalized. FINANCIAL HIGHLIGHTS Foreign exchange impact: The RMB depreciated against the U.S. dollar on average by approximately 5% during 2023, which has impacted our consolidated financial results as highlighted below. Cash, Cash Equivalents and Short-Term Investments were $886.3 million as of December 31, 2023 compared to $631.0 million as of December 31, 2022. Adjusted Group (non-GAAP47) net cash flows excluding financing activities in 2023 were $206.7 million (2022: -$297.9m) mainly due to the receipt of $435 million in upfront and milestone payments from Takeda; andNet cash generated from financing activities in 2023 totaled $48.7 million mainly due to the drawdowns of bank borrowings (2022: net cash used in financing activities of $82.8m). Revenue for the year ended December 31, 2023 were $838.0 million compared to $426.4 million in 2022. Oncology/Immunology consolidated revenue increased 223% (228% at CER) to $528.6 million (2022: $163.8m) resulting from: ELUNATE® revenue increased 19% (26% at CER) to $83.2 million (2022: $69.9m) due to continued market share gains, comprising of manufacturing revenue, promotion and marketing service revenue and royalties;FRUZAQLA™ revenue was $7.2 million, reflecting its U.S. launch in early November 2023, comprising of manufacturing revenue and royalties;SULANDA® revenue increased 36% (43% at CER) to $43.9 million (2022: $32.3m) from our continuing marketing activities, increasing patient access and longer durations of treatment;ORPATHYS® revenue increased 30% (37% at CER) to $28.9 million (2022: $22.3m) after inclusion in the NRDL effective from March 2023, comprising of manufacturing revenue and royalties;TAZVERIK® revenue was $1.0 million (2022: $0.1m) from further sales in the Hainan Pilot Zone;Partnering revenue of $312.0 million was the $280 million recognized portion of the $400 million upfront payment, and the $32 million recognized portion of the US$35 million milestone payment from Takeda; andOther R&D services income of $52.4 million (2022: $24.2m), primarily related to fees from AstraZeneca, Lilly and Takeda for the management of development and regulatory activities. Other Ventures consolidated revenue increased 18% (24% at CER) to $309.4 million (2022: $262.6m), mainly due to higher sales of prescription drugs. This excludes 4% (10% at CER) growth in non-consolidated revenue at SHPL of $385.5 million (2022: $370.6m). Net Expenses for 2023 were $737.2 million compared to $787.2 million in 2022. Cost of Revenue increased by 24% to $384.4 million (2022: $311.1m), of which cost of revenue from our Other Ventures increased by 21% to $292.7 million (2022: $241.9m) due to the increasing sales of third-party prescription drug products. Cost of revenue from Oncology/Immunology increased by 33% to $91.7 million (2022: $69.2m) due to the increase in product sales of our marketed products and the cost of provision of promotion and marketing services for ELUNATE® resulting from the increased sales force;R&D Expenses reduced 22% to $302.0 million (2022: $386.9m), mainly due to the completion of several large registration-enabling trials, the focus on ex-China development through partnerships, and the ongoing strategic prioritization of our pipeline. Our international clinical and regulatory operations in the U.S. and Europe incurred expenses of $106.9 million (2022: $170.9m), while R&D expenses in China were $195.1 million (2022: $216.0m);SG&A48 Expenses were $133.2 million (2022: $136.1m), which decreased primarily due to the restructuring of our U.S. Oncology/Immunology commercial operations at the end of 2022 while our China commercial infrastructure was able to support further revenue growth; andOther Items mainly comprised of equity in earnings of SHPL, interest income and expense, FX and taxes, generated net income of $82.4 million (2022: $46.9m), which increased primarily due to higher interest income after receiving the $400 million Takeda upfront payment. Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022. The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022. FINANCIAL SUMMARY Condensed Consolidated Balance Sheets Data(in $’000) As of December 31, 2023 2022Assets Cash and cash equivalents and short-term investments886,336 630,996Accounts receivable116,894 97,988Other current assets93,609 110,904Property, plant and equipment99,727 75,947Investments in equity investees48,411 73,777Other non-current assets34,796 39,833Total assets1,279,773 1,029,445Liabilities and shareholders’ equity Accounts payable36,327 71,115Other payables, accruals and advance receipts271,399 264,621Deferred revenue127,119 13,537Bank borrowings79,344 18,104Other liabilities22,197 25,198Total liabilities536,386 392,575Company’s shareholders’ equity730,541 610,367Non-controlling interests12,846 26,503Total liabilities and shareholders’ equity1,279,773 1,029,445 Condensed Consolidated Statements of Operations Data(in $’000, except share and per share data) Year Ended December 31, 2023 2022 Revenue: Oncology/Immunology – Marketed Products164,165 124,642 Oncology/Immunology – R&D364,451 39,202 Oncology/Immunology consolidated revenue528,616 163,844 Other Ventures309,383 262,565 Total revenue837,999 426,409 Operating expenses: Cost of revenue(384,447) (311,103)Research and development expenses(302,001) (386,893)Selling and general administrative expenses(133,176) (136,106)Total operating expenses(819,624) (834,102) Other income/(expense), net39,933 (2,729)Income/(loss) before income taxes and equity in earnings of equity investees58,308 (410,422)Income tax (expense)/benefit(4,509) 283 Equity in earnings of equity investees, net of tax47,295 49,753 Net income/(loss)101,094 (360,386)Less: Net income attributable to non-controlling interests(314) (449)Net income/(loss) attributable to HUTCHMED100,780 (360,835) Earnings/(losses) per share attributable to HUTCHMED (US$ per share) – basic 0.12 (0.43)– diluted0.12 (0.43)Number of shares used in per share calculation – basic849,654,296 847,143,540 – diluted869,196,348 847,143,540 Earnings/(losses) per ADS attributable to HUTCHMED (US$ per ADS) – basic 0.59 (2.13)– diluted0.58 (2.13)Number of ADSs used in per share calculation – basic169,930,859 169,428,708 – diluted173,839,270 169,428,708 OUTLOOK AND FINANCIAL GUIDANCE 2023 was an impressive year for HUTCHMED, in large part due to the upfront payment of $400 million received from Takeda, of which $280 million was recognized in revenue during 2023, with the remainder to be recognized when services and performance obligations are completed over approximately three years. Full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED’s work in 2024 and beyond will be supported by its strong balance sheet, which grew by $255 million to $886 million in Cash, Cash Equivalents and Short-Term Investments as of December 31, 2023. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide. Shareholders and investors should note that: we do not provide any guarantee that the statements contained in the financial guidance will materialize or that the financial results contained therein will be achieved or are likely to be achieved; andwe have in the past revised our financial guidance and reference should be made to any announcements published by us regarding any updates to the financial guidance after the date of publication of this announcement. 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 calls and audio webcast presentations scheduled today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English. In addition to the usual English webcast, there will also be a Chinese (Putonghua) webcast at 8:30 a.m. HKT on Thursday, February 29, 2024. 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. FINANCIAL STATEMENTS HUTCHMED will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F. About HUTCHMED HUTCHMED (Nasdaq/AIM: ​HCM; HKEX: ​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines now approved marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. Contacts Investor Enquiries+852 2121 8200 / +1 973 306 4490 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon+44 (20) 7886 2500 References 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 have been obtained will continue to remain valid and effective in the future, 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; discovery, development and/or commercialization of 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 pandemics and disease outbreaks. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX50. 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. Inside Information 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). Medical Information This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. This announcement in its entirety is available at: http://ml.globenewswire.com/Resource/Download/2764a8e2-c30d-4c40-ae43-56309cc71d54 REFERENCES AND ABBRIVATIONS 1. Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.2. R&D = Research and development.3. NDA = New Drug Application.4.NSCLC = Non-small cell lung cancer.5.FDA = Food and Drug Administration.6.PDUFA = U.S. Prescription Drug User Fee Act.7.CRC = Colorectal cancer.8.NCCN = National Comprehensive Cancer Network.9.In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA™), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).10.MAA = Marketing Authorization Application.11.EMA = European Medicines Agency.12.PMDA = Pharmaceuticals and Medical Devices Agency.13.EMC = Endometrial cancer.14.RCC = Renal cell carcinoma.15.NMPA = National Medical Products Administration.16.Syk = Spleen tyrosine kinase.17.ITP = Immune thrombocytopenia purpura.18.AstraZeneca = AstraZeneca AB, a subsidiary of AstraZeneca plc.19.CER = Constant exchange rate. We also report changes in performance at CER which is a non-GAAP measure. Please refer to “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.20.Source: IQVIA. Report on file.21.TPO = Thrombopoietin; TPO-RAs = Thrombopoietin receptor agonists.22.MET = Mesenchymal epithelial transition factor.23.EGFR = Epidermal growth factor receptor.24.TKI = Tyrosine kinase inhibitor.25.NRDL = National Reimbursement Drug List.26.Lilly = Eli Lilly and Company.27.VEGFR = Vascular endothelial growth factor receptor.28.ASCO = American Society of Clinical Oncology.29.PFS = Progression free survival.30.ORR = Objective response rate.31.DCR = Disease control rate.32.OS = Overall survival.33.PD-1 = Programmed cell death protein-1.34.FGFR = Fibroblast growth factor receptor.35.CSF-1R = Colony-stimulating factor 1 receptor.36.AACR = American Association for Cancer Research.37.AIHA = Autoimmune hemolytic anemia.38.Ipsen = Ipsen SA, parent of Epizyme Inc.39.DoR = Duration of response.40.IHCC = Intrahepatic cholangiocarcinoma.41.PI3Kδ = Phosphoinositide 3-kinase delta.42.Inmagene = Inmagene Biopharmaceuticals.43.BTK = Bruton tyrosine kinase.44.SHPL = Shanghai Hutchison Pharmaceuticals Limited.45.HHOHK = Hutchison Hain Organic (Hong Kong) Limited.46.HSN = HUTCHMED Science Nutrition Limited.47.GAAP = Generally Accepted Accounting Principles.48.SG&A= Selling, general, and administrative expenses.49.ADS = American depositary share.50.HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.

Learn more about Servier's leadership in mutant IDH inhibition at ASH booth #1347 BOSTON, Dec. 9, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will be presenting new data in acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. These data provide a compelling and in-depth look into the treatment patterns and clinical outcomes observed in real-world settings, offering valuable insights for informed decision-making in patient care. "During our initial five years in the oncology space, Servier has more than doubled its portfolio and launched several new indications for TIBSOVO in IDH1-mutant cancers, including frontline AML, myelodysplastic syndromes (MDS) and previously treated cholangiocarcinoma (CCA) - many of these indications serving as a best-in-class treatment option," said Arjun Prasad," Head of Commercial, Servier Pharmaceuticals. "As the leader driving the science behind targeted mutant IDH inhibition, we strive to maximize the benefits of molecular testing to improve patient outcomes and continue to focus on areas of unmet need where patients could benefit from personalized medicine, from our multiple approvals across hematology and solid tumors to ongoing research in difficult to treat and rare cancers such as chondrosarcoma." More information on testing for IDH mutations in cancer can be found at IDHlearnmore.com. Data being presented at ASH include real-world evidence analysis in patients with newly diagnosed AML (intensive chemotherapy induction ineligible (ICIE) and a susceptible IDH1 mutation comparing Tibsovo in combination with hypomethylating agents (HMA) versus venetoclax in combination with hypomethylating agents. In the analysis of 238 patients, Tibsovo+HMA elicited a higher complete response (CR) rate versus venetoclax+HMA at 42.9% vs. 26.7% (p=0.007). 6-month event-free survival also favored Tibsovo+HMA at 56.0% vs. 39.6% (p=0.044), as well as 11.5% of patients on Tibsovo+HMA achieving bridge to transplant versus 5.0% on a venetoclax+HMA regimen (p=0.066). Median time from diagnosis to start of treatment was 14 versus 20 days for Tibsovo+HMA vs venetoclax+HMA. Treatment discontinuation was 37% for both regimens and toxicity incidence was similar, with the exception of higher febrile neutropenia (FN) rates for venetoclax+HMA versus Tibsovo+HMA (7.9% vs. 1.6%; p=0.009). Patients receiving Tibsovo+HMA had a 61% lower relative risk of unscheduled acute care use in the first 12 weeks (42.9% versus 70.3% for venetoclax+HMA; p<0.001). Venetoclax schedule intensity was also captured, with only 22.8% receiving the full FDA-labeled 28 days of venetoclax during the 28-day cycles; 44.6% did not receive >11 days of venetoclax per cycle. The full analysis will be presented on Monday, December 11 at 4:30 p.m. PST. "At Servier, we bring the patient voice into everything we do, and our commitment to patients extends far beyond approval," emphasized Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals. "As a privately held company, we have the ability to invest in the long-term in ways that help to create better understandings on the real-world impact our medicines have on the lives of patients. We're proud to once again present real-world evidence at ASH, offering the broader oncology community insights into treatment patterns that can help in the development of the best possible treatment regimen for each individual patient." Additional data being presented at ASH includes molecular measurable residual disease (MRD) in ICIE patients with newly diagnosed mIDH1 AML treated with Tibsovo+azacitidine, further bolstering the clinical profile of Tibsovo in the front-line setting, as well as real-world analyses examining treatment patterns in both ALL and AML. About Servier in Oncology Servier is a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves. Governed by a non-profit foundation, Servier approaches innovation with a long-term vision, free of influence from investors and outside pressure to chase short-term monetary targets. As a leader in oncology, Servier has significantly accelerated its investment in difficult and hard-to-treat cancers, with more than 50% of its research and development dedicated to delivering significant advances in areas of high unmet need throughout oncology with the potential to change the lives of the patients it serves. Within these areas, Servier is the leader in mutant IDH inhibition, with the first ever mutant IDH1 inhibitor approved in the U.S. and the European Union, and the company continues to drive the science behind targeted mutant IDH inhibition. Servier's commitment to therapeutic progress guides its collaboration strategy. While many companies across the industry are scaling back investments, Servier is actively building alliances, completing acquisitions, conducting licensing deals and entering new partnerships that can help to accelerate access to therapies for patients in need. With the company's commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier is dedicated to bringing the promise of tomorrow to the patients it serves. Press Contact Servier Pharmaceuticals Nathan Mellor [email protected] Disclosures This release contains general information about the Servier Group and its entities (hereinafter "Servier and its Affiliates") and is intended for informational purposes only. The information is thought to be reliable; however, Servier and its Affiliates make no representation as to the accuracy or completeness of the information contained herein or otherwise provided and accept no responsibility or liability, in contract, in tort, in negligence, or otherwise, should the information be found to be inaccurate or incomplete in any respect. Servier and its Affiliates are not acting as an advisor to the recipient of this information, and the ultimate decision to proceed with any transaction rests solely with the recipient of this information. Therefore, prior to entering into any proposed transaction, the recipient of this information should determine, without reliance upon Servier or its Affiliates, the economic risks and merits, as well as the legal, tax, and accounting characterizations and consequences, of the transaction and that it is able to assume these risks. This statement also contains forward-looking statements that are subject to varying levels of uncertainty and risk. Investigational new drugs and indications are subject to further scientific and medical review and regulatory approval. They are not approved for use by the FDA. Any reliance placed on this document is done entirely at the risk of the person placing such reliance. The information contained in this document is neither an offer to sell nor the solicitation of an offer to enter into a transaction. The content of this document is a summary only, is not complete, and does not include all material information about Servier and its Affiliates, including potential conflicts of interest. To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates disclaim all representations, warranties, conditions and guarantees, whether express, implied, statutory or of other kind, nor does it accept any duty to any person, in connection with this document. Without prejudice to the generality of the foregoing, Servier and its Affiliates do not warrant or represent that the information or opinions contained in this document is accurate or complete. To the maximum extent permitted by applicable laws and regulations, Servier and its Affiliates shall not be liable for any loss, damage or expense whatsoever, whether direct or indirect, howsoever arising, whether in contract, tort (including negligence), strict liability or otherwise, for direct, indirect, incidental, consequential, punitive or special damages arising out of or in connection with this document, including (without limitation) any course of action taken on the basis of the same. The estimates, strategies, and views expressed in this document are based upon past or current data and information and are subject to change without notice. TIBSOVO IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS INDICATIONS TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy Relapsed or Refractory AML For the treatment of adult patients with relapsed or refractory AML Relapsed or Refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes Locally Advanced or Metastatic Cholangiocarcinoma For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated IMPORTANT SAFETY INFORMATION WARNING: DIFFERENTIATION SYNDROME IN AML AND MDS Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution. WARNINGS AND PRECAUTIONS Differentiation Syndrome in AML and MDS: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome and creatinine increased. If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe. QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary. Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia. Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with TIBSOVO. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome. ADVERSE REACTIONS In patients with AML, the most common adverse reactions including laboratory abnormalities (≥25%) are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia In patients with MDS, the most common adverse reactions including laboratory abnormalities (≥25%) are creatinine increased, hemoglobin decreased, arthralgia, albumin decreased, aspartate aminotransferase increased, fatigue, diarrhea, cough, sodium decreased, mucositis, decreased appetite, myalgia, phosphate decreased, pruritus, and rash In patients with cholangiocarcinoma, the most common adverse reactions (≥15%) in patients with cholangiocarcinoma are fatigue, nausea, abdominal pain, diarrhea, cough, decreased appetite, ascites, vomiting, anemia, and rash. The most common laboratory abnormalities (≥10%) in patients with cholangiocarcinoma are hemoglobin decreased, aspartate aminotransferase increased, and bilirubin increased DRUG INTERACTIONS Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation. Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO. Sensitive CYP3A4 substrates: Avoid concomitant use with TIBSOVO. QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation. LACTATION: Advise women not to breastfeed. Please see Full Prescribing Information , including BOXED WARNING for AML and MDS patients. SOURCE Servier Pharmaceuticals