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HUTCHMED(13.HK):A FRUITFUL 2024 ON THE WAY

HUTCHMED(13.HK):A FRUITFUL 2024 ON THE WAY

HUTCHMED (13.HK):富有成效的2024年即將到來
招银国际 ·  03/01

Including US$312mn upfront and milestone payments from Takeda, HCM's consolidated revenues from oncology/immunology reached US$529mn in FY23 (vs US$164mn in FY22), close to the upper limit of its US$450-550mn guidance. The in-market product sales increased 28% YoY (35% at CER) to US$214mn in FY23, among which sales of fruquintinib in China increased 15% YoY (22% at CER) to US$108mn, maintaining leadership in patient share (47%) in 3L CRC. Fruquintinib recorded US$15mn in sales in the overseas market in 2023 since the launch in Nov. Surufatinib's in-market sales in FY23 increased 36% YoY (43% at CER) to US$44mn, and ranked 2nd in the NET market with 21% share in 4Q23. Savolitinib's in-market sales in FY23 increased 12% YoY (19% at CER) to US$46mn, even with a 38% price cut for NRDL inclusion since Mar 2023. Mgmt guides the FY24E consolidated revenue from oncology/immunology to reach US$300-400mn, driven by 30% to 50% growth in oncology marketed product revenue. In FY23, HCM spent US$302mn on R&D, down 22% YoY, due to the completion of several large registration-enabling trials, the focus on ex-China development through partnerships and the strategic prioritization of pipeline. HCM recorded a net income of US$101mn in FY23. As of end-2023, HCM had a strong cash position of US$886mn. Management is confident to turn profitable in FY25E.

包括武田的3.12億美元預付款和里程碑式付款,HCM的腫瘤/免疫學合併收入在23財年達到5.29億美元(22財年爲1.64億美元),接近其4.5億至5.5億美元預期的上限。23財年,市場內產品銷售額同比增長28%(按恒定匯率計算爲35%),達到2.14億美元,其中呋喹替尼在中國的銷售額同比增長15%(按CER計算爲22%),達到1.08億美元,保持了3L CRC患者份額(47%)的領先地位。自11月推出以來,呋喹替尼在2023年海外市場的銷售額達到1500萬美元。索凡替尼在23財年的市場銷售額同比增長36%(按CER計算爲43%),達到4,400萬美元,在淨市場中排名第二,在23年第四季度佔有21%的份額。儘管自2023年3月以來納入NRDL的價格下調了38%,但賽沃利替尼在23財年的市場內銷售額同比增長了12%(按恒定匯率計算爲19%),至4600萬美元。管理層指導,在腫瘤學市場產品收入增長30%至50%的推動下,來自腫瘤學/免疫學的 FY24E 合併收入將達到3億至4億美元。在23財年,HCM的研發支出爲3.02億美元,同比下降22%,這要歸因於幾項支持註冊的大型試驗、通過夥伴關係將重點放在中國以外的發展以及管道的戰略優先順序排列。HCM在23財年的淨收入爲1.01億美元。截至2023年底,HCM的現金狀況強勁,爲8.86億美元。管理層有信心在 FY25E 中實現盈利。

Fruquintinib shows potential for expanded indications in China and aims for wider international approvals. The NDAs of fruquintinib for CRC are under review in the EU and Japan (NDAs submitted in Jun and Sep 2023, respectively). In China, fruquintinib may receive approval for 2L GC in 2H24E (sNDA in Apr 2023). Cross- trial comparison shows fruquitinib's superior efficacy than ramucirumab in 2L GC patients. Additionally, fruquintinib + sintilimab received BTD for endometrial cancer (pMMR type) in China, and the potential Ph2 registration trial in China completed patient enrolment in Jul 2023, with the sNDA filing expected in early 2024E. The Ph2/3 trial of fruquintinib + sintilimab for 2L RCC completed enrolment in Dec 2023, with the top line results expected by end-2024E.

呋喹替尼顯示出在中國擴大適應症的潛力,旨在獲得更廣泛的國際批准。歐盟和日本正在審查呋喹替尼治療結直腸癌的新藥申請(分別於2023年6月和9月提交保密協議)。在中國,呋喹替尼可能會獲准在 2H24E 中使用 2L GC(2023 年 4 月的snDa)。交叉試驗比較顯示,在2L GC患者中,呋喹替尼的療效優於拉穆西魯單抗。此外,呋喹替尼+辛替利單抗在中國接受了子宮內膜癌(pMMR型)的BTD,中國潛在的Ph2註冊試驗於2023年7月完成了患者入組,預計將在2024年初提交sndA。fruquintinib + sintilimab 用於 2L RCC 的 Ph2/3 試驗已於 2023 年 12 月完成註冊,預計最早結果將於 2024 年底公佈。

Savolitinib to become the company's second product to achieve global commercialization. The global Ph2 SAVANNAH trial of savolitinib in 2/3L osimertinib-refractory MET+ NSCLC finished enrolment in Feb 2024. We anticipate the US NDA submission for accelerated approval by the end of 2024, and savolitinib potentially to be positioned as HCM's second product to reach the global market. Compared with other competing therapies, savolitinib + osimertinib offers potentially better efficacy for specific MET+ patients, and its oral administration route is more convenient over other competing therapies. In China, savolitinib has the potential to expand its label into 1L MET Exon 14 NSCLC with the filing expected in 1Q24E based on positive results from confirmatory Ph3b study.

賽沃利替尼將成爲該公司第二款實現全球商業化的產品。沃利替尼在2/3L奧西替尼難治性MET+ NSCLC中進行沃利替尼的全球Ph2 SAVANNAH試驗已於2024年2月完成註冊。我們預計,到2024年底,美國新藥上市申請將加快審批,而賽沃利替尼有可能成爲HCM第二款進入全球市場的產品。與其他競爭療法相比,賽沃利替尼+奧西替尼可能爲特定的MET+患者提供更好的療效,而且其口服給藥途徑比其他競爭療法更爲便利。在中國,沃利替尼有可能將其標籤擴展到1L MET Exon 14 NSCLC,根據確認性pH3b研究的積極結果,預計將在 1Q24E 中提交。

Sovleplenib, a promising best-in-class Syk inhibitor, holds strong potential for overseas licensing. The China Ph3 ESLIM-01 trial of sovleplenib for ITP met its endpoints, leading to the acceptance of the NDA by the NMPA in Jan 2024, with the status of priority review. Concurrently, HCM is initiating a Ph1b/II trial in the US for ITP. Moreover, HCM is on track to unveil detailed Ph3 ITP results by mid-2024 and Ph2 wAIHA data as well. The anticipated data release is expected to act as a significant catalyst for potential international out-licensing agreements.

Sovleplenib是一種前景看好的同類最佳Syk抑制劑,具有巨大的海外許可潛力。用於ITP的sovleplenib的中國Ph3 ESLIM-01 試驗已達到其終點,導致國家藥品監督管理局於2024年1月接受了新藥申請,並處於優先審查狀態。同時,HCM正在美國啓動一項針對ITP的pH1B/II試驗。此外,HCM有望在2024年中期之前公佈第三階段的詳細ITP結果,並公佈第二階段的WaiHA數據。預計公佈的數據將成爲潛在國際外包許可協議的重要催化劑。

Maintain BUY. Considering the company's guidance, we revise our TP from HK$36.67 to HK$34.31 based on DCF valuation (WACC: 10.25 %, terminal growth rate: 3.0%).

維持買入。考慮到公司的指導,我們將目標從36.67港元上調至34.31港元,基於差價合約估值(WACC:10.25%,最終增長率:3.0%)。

譯文內容由第三人軟體翻譯。


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