AKESO INC(9926.HK):1H24 RESULTS IN LINE;SHOWCASING OUTSTANDING R&D AND EXECUTIVE ABILITY
AKESO INC(9926.HK):1H24 RESULTS IN LINE;SHOWCASING OUTSTANDING R&D AND EXECUTIVE ABILITY
1H24 results were in line with BOCIe, with product sales up 22% YoY to RMB971m, including RMB706m sales of AK104 (+16.5% YoY) and RMB103m sales of AK112. Akeso's strong executive ability was reflected by strict expenses control, continued pipeline progress, including phase III studies initiation of the backbone drugs AK104 and AK112 and new candidates and R&D platform exploration. We like Akeso' self-developed comprehensive pipeline and keep close eyes on the data push of AK112 in PD-L1+ NSCLC in September. Maintain BUY and TP of HK$65.
1H24的業績符合中國銀河國際的預期，產品銷售額同比增長22%，達到人民幣97100萬元，其中AK104銷售額爲70600萬元（同比增長16.5%），AK112銷售額爲10300萬元。康方生物通過嚴格控制費用、持續推進管線進展、啓動AK104和AK112等重要藥物的三期研究以及新的候選藥物和研發平台的探索，展現出了強大的執行能力。我們對康方自主研發的綜合管線非常看好，並密切關注9月份PD-L1陽性非小細胞肺癌中AK112的數據推送。維持買入評級和目標價65港元。
Key Factors for Rating
評級的關鍵因素
1H24 results in line: product sales increased by 22% YoY to RMB971m, in line with BOCIe, including sales of AK104 (cadonilimab, PD-1/CTLA-4) which grew 16.5% YoY to RMB706m. AK112 (ivonescimab, PD-1/VEGF), which was approved by NMPA on 24 May, delivered sales of RMB103m in 1H24, demonstrating the consistent executive ability. Gross margin of drugs improved 1ppt to 92%. Total selling expenses ratio (including PD-1) dipped 4ppts to 56%. R&D expenses and administrative expenses changed by +3% and -1% to RMB594m and RMB100m, respectively. The management expects R&D expenses and administrative expense to be RMB1.3bn-1.4bn and RMB200m-210m in 2024, respectively. Net loss was RMB239m in 1H24 vs. net profit of RMB2.53bn in 1H23, due to a lack of license income from Summit Therapeutics (SMMT US/NR). As of 30 June, Akeso has cash & trading assets of RMB5.69bn.
1H24的業績符合中國銀河國際的預期，產品銷售額同比增長22%，達到人民幣97100萬元，與BOCIe相符，其中AK104（卡多尼利單抗，PD-1/CTLA-4）的銷售額同比增長16.5%，達到70600萬元。AK112（伊沃尼西單抗，PD-1/VEGF）於5月24日獲得國家藥監局批准，在1H24實現了10300萬元的銷售額，展現了持續的執行能力。藥品毛利率提高了1個百分點，達到92%。總銷售費用率（包括PD-1）下降了4個百分點，達到56%。研發費用和管理費用分別增長了3%和下降了1%，分別達到59400萬元和10000萬元。管理層預計2024年的研發費用和管理費用分別爲13億至14億人民幣和2.1億元至2.2億元。1H24的淨虧損爲23900萬元，而1H23的淨利潤爲25.3億元，原因是沒有來自Summit Therapeutics（SMMt US/NR）的許可收益。截至6月30日，康方生物的現金和交易資產爲569億元人民幣。
AK104 and AK112, as the backbone drugs, continue to expand indication: AK104: apart from the sNDA in 1L GC and 1L CC under NMPA review, Akeso has initiated 5 phase III studies in PD-L1- NSCLC, adjuvant treatment HCC, + pulocimab (AK109, VEGFR-2) in 2L PD-(L)1 failed GC, +levatinib + TACE in unresectable HCC, and mono for concurrent/sequent NSCLC. AK112: apart from the sNDA review in 1L PD-L1+ NSCLC, Akeso has initiated/planed 4 phase III studies in +chemo vs tislelizumab + chemo in 1L sqNSCLC, +chemo vs. durvalumab in 1L BTC, + ligufalimab (AK117, CD47) vs. pembrolizumab in 1L PD-L1+ HNSCC, and +chemo in 1L PDAC. AK112 is the only drug that has initiated head-to-head trial vs. tislelizumab, durvalumab and pembrolizumab globally, demonstrating the management's confidence in AK112's efficacy and clinical value.
作爲重要藥物，AK104和AK112繼續擴大適應症範圍：AK104：除了正在國家藥監局審查的一線胃癌和一線結直腸癌的sNDA外，康方生物還啓動了5項PD-L1陰性非小細胞肺癌的三期研究，以及肝細胞癌的輔助治療（使用AK109 + 普洛西姆單抗），PD-(L)1治療失敗的二線胃癌（使用柳氮磷單抗 + 樂伐替尼 + TACE），以及分隔或連續使用的非小細胞肺癌單藥。AK112：除了正在一線PD-L1陽性非小細胞肺癌審查的sNDA外，康方生物還啓動了或計劃啓動4項三期研究，包括和化療比較維仙尼單抗 + 化療治療一線鱗狀非小細胞肺癌，和化療比較達伐單抗治療一線膽道癌，和利古法利單抗（CD47）比較奧希曲單抗治療一線PD-L1陽性頭頸部鱗狀細胞癌，以及與化療比較治療一線胰腺癌。AK112是唯一全球啓動與維仙尼單抗、達伐單抗和奧希曲單抗進行頭對頭比較試驗的藥物，展示了管理層對AK112的功效和臨床價值的信心。
Early stage candidates: during the call, the management introduced three candidates that have obtained/submitted IND approval/application and will initiate phase I studies in 2H24, including AK135 (IL-1RAP) in chemotherapy- induced peripheral neuropathy, AK137 (CD73/LAG3) in tumour and AK138D (HER3 ADC) in tumour. Besides, the management expects to submit IND approval for a bsAb ADC in 2H24.
早期候選者：在電話會議中，管理層介紹了三個候選者，它們已獲得/提交了IND批准/申請，並將於2H24啓動I期研究，包括AK135（IL-1RAP）用於化療引起的周圍神經病變、AK137（CD73/LAG3）用於腫瘤和AK138D（HER3 ADC）用於腫瘤。此外，管理層預計於2H24提交一種bsAb ADC的IND批准申請。
Key Risks for Rating
評級的主要風險
i) Failure of regulatory filing; ii) slower-than-expected sales ramp-up of new drugs; and iii) failure of major clinical trials.
i）監管申報的失敗； ii）新藥銷售增長速度低於預期；和iii）重大臨床試驗的失敗。
Valuation
估值
Post results, we fine-tune our 2024-26E forecasts, maintain BUY rating and TP of HK$65.
發佈結果後，我們微調了2024-26E的預測，維持買入評級和65港元的目標價。
譯文內容由第三人軟體翻譯。