HUTCHMED(13.HK):FRUQUINTINIB'S OVERSEAS SALES BEAT
HUTCHMED(13.HK):FRUQUINTINIB'S OVERSEAS SALES BEAT
HCM's oncology/immunology product revenue reached US$128mn in 1H24 (+59.6% YoY), including US$43mn revenue recognised from fruquintinib's sales outside China. The consolidated revenue from oncology/immunology including R&D services and Takeda collaboration revenue, reached US$169mn in 1H24, representing 48% of the midpoint of the FY24 guidance range of US$300-400mn.
HCM腫瘤/免疫產品的營業收入在上半年達到了1.28億美元(同比增長59.6%),其中包括在中國境外銷售fruitintinib的4300萬美元收入。腫瘤/免疫學領域的綜合營收包括研發服務和武田合作收入,在1H24達到了1.69億美元,佔FY24指導範圍300-400億美元中點的48%。
In 2Q24, fruquintinib recorded strong sales in the US market, +53% QoQ to JPY11.9bn (or c. US$80mn), up from JPY7.8bn (or c. US$52mn) in 1Q24. The growth has beaten our expectation, reflecting strong demand in the US. With imminent commercialization in EU, Japan and other global markets, we expect fruquintinib to maintain its strong sales momentum outside China in 2024 and beyond. In China, the in-market sales of fruquintinib, savolitinib and surufatinib in 1H24 increased by 8%, 18%, and 12% YoY, respectively, with the revenue to HCM +10%/-13%/+12% YoY to US$46mn/13mn/25mn. HCM's consolidated revenues from oncology/immunology in China maintained relatively stable growth, increasing 6% YoY or 11% HoH to US$85mn in 1H24. Fruquintinib maintained its leading position in the China 3L CRC market, while savolitinib could face fierce competition in the China cMET inhibitor market. HCM's R&D expenditures were US$95mn in 1H24, down 34% YoY. HCM recorded a net income of US$26mn in 1H24. As of Jun 2024, HCM held a strong cash position of US$803mn.
在第二季度,fruquintinib在美國市場的銷售額強勁增長,環比增長53%至119億日元(約爲8,000萬美元),較一季度的78億日元(約爲5,200萬美元)增長;增長超出了我們的預期,反映出美國市場的強勁需求。隨着在歐洲、日本和其他全球市場的市場化即將到來,我們預計fruquintinib將在2024年及以後在中國境外保持其強勁的銷售勢頭。在中國,fruquintinib、savolitinib和surufatinib的在市場銷售額分別同比增長了8%、18%和12%,對HCM的營業收入同比增長了10%/-13%/+12%,分別達到了4600萬美元/1300萬美元/2500萬美元。HCM在腫瘤/免疫學領域的綜合營收在中國保持了相對穩定的增長,1H24同比增長了6%或環比增長11%,達到了8500萬美元。fruquintinib在中國3線結直腸癌市場中保持領先地位,而savolitinib在中國cMEt抑制劑市場中可能面臨激烈競爭。HCM的研發支出在1H24爲9500萬美元,同比下降34%。HCM在1H24錄得淨利潤2600萬美元。截至2024年6月,HCM持有80300萬美元的強勁現金地位。
Fruquintinib shows potential for indication expansion in China. In China,fruquintinib may receive CDE decision for the sDNA for 2L GC in 3Q24 (sNDA submitted in Apr 2023). Recall that the OS endpoint was not met in the Ph3 FRUTIGA trial. Furthermore, fruquintinib combined with sintilimab received BTD for endometrial cancer (pMMR type) in China, with an sNDA filed in Apr 2024, supported by promising results recently released at ASCO (CMBI report: link). Additionally, we expect another sNDA of fruquintinib + sintilimab for 2L renal cancer to be filed by end-2024. The expanded indications will contribute to fruquintinib's further sales growth in China.
fruquintinib在中國顯示出擴展適應症的潛力。在中國,fruquintinib可能會在3Q24獲得sDNA適應症評估決定來治療2線胃癌(sNDA在2023年4月提交)。請注意,Ph3 FRUTIGA試驗中未達到OS終點。此外,fruquintinib + sintilimab聯合用於治療結腸癌(pMMR型)已經在中國獲得了BTD,並在2024年4月提交了sNDA,近期在ASCO會議上發佈了有前途的結果(CMBI報告: link)。此外,我們預計fruquintinib + sintilimab在治療2線腎癌方面的另一個sNDA將在2024年底前提交。擴大適應症將有助於fruquintinib在中國進一步增長銷售額。
Savolitinib to become the company's second product to achieve globalcommercialization. The global Ph2 SAVANNAH trial of savolitinib in 2/3L osimertinib-refractory MET+ NSCLC finished enrolment in Feb 2024. We expect AZ to file the NDA to the US FDA for accelerated approval by the end of 2024, contingent on positive trial outcomes. This could establish savolitinib as HCM's second product in the global marketplace. In China, there is potential for savolitinib to broaden its indications to include first-line MET Exon 14 NSCLC, following a filing in Mar 2024. We believe this expansion would enhance its competitive stance in the cMET inhibitor market upon approval.
savolitinib將成爲公司第二個實現全球商業化的產品。savolitinib在2/3L osimertinib難治性MET+ NSCLC的全球Ph2 SAVANNAH試驗在2024年2月完成了受試者招募。我們預計英國阿斯利康公司將在2024年底根據試驗結果提交加速批准的NDA申請。在這種情況下,savolitinib將成爲HCM在全球市場上的第二個產品。在中國,savolitinib有潛力擴大其適應症範圍,包括在2024年3月提交的首線MEt內含子14型NSCLC。我們認爲,這種擴張將增強其在cMEt抑制劑市場上的競爭地位。
Sovleplenib, a potential best-in-class Syk inhibitor, exhibits significantpotential for overseas licensing. In the Ph3 ESLIM-01 trial, sovleplenib demonstrated BIC potential for ITP, achieving a high durable response rate of 48% observed. Following the NDA submission in Jan 2024, we anticipate that sovleplenib will allow the Company to penetrate the autoimmune disease market. HCM is conducting a Ph1b ITP trial in the US/EU, which will facilitate the potential out-licensing upon positive data readout, in our view.
Sovleplenib,一種潛在的最佳Syk抑制劑,在海外授權方面具有重要潛力。在Ph3 ESLIm-01試驗中,sovleplenib表現出ITP最佳治療組合的潛力,實現了48%的高持久性響應率。在2024年1月提交NDA之後,我們預計sovleplenib將使公司進入自身免疫性疾病市場。HCM正在美國和歐盟進行Ph10億的ITP試驗,我們認爲該試驗將在積極數據披露後促進潛在的外部授權。
Maintain BUY. Considering fruquintinib's strong US sales momentum and near-term launch in other regions outside China, we raise our TP from HK$34.31 to HK$35.61 based on DCF valuation (WACC: 10.95 %, terminal growth rate: 3.0%). BUY.
維持買入。考慮到fruquintinib在美國銷售勢頭強勁並即將在中國境外其他地區推出,我們根據DCF估值(WACC: 10.95 %,終止增長率: 3.0%)將目標價從HK $34.31上調至HK $35.61。買入。
譯文內容由第三人軟體翻譯。