AKESO(9926.HK):EYES ON THE DETAILED HEAD-TO-HEAD DATA OF AK112 AT WCLC IN SEP
AKESO(9926.HK):EYES ON THE DETAILED HEAD-TO-HEAD DATA OF AK112 AT WCLC IN SEP
Maintain BUY. We look forward to the detailed data of AK112 at the coming WCLC. Akeso's non-oncology products are nearing commercialization with NDAs for PCSK9 mAb and IL12/23 mAb under review. We expect AK104 and AK112 be covered by NRDL early next year. We revise our TP from HK$59.61 to HK$58.97 (WACC: 10.47%, terminal growth rate: 3.5%).In 1H24, Akeso recorded RMB1.03bn in revenue, including RMB939mn from product sales. Cadonilimab/AK104 (PD-1/CTLA-4) recorded RMB706mn in sales in 1H24, +16% YoY or -6% HoH, accounting for 39% of our previous full-year estimate. We attribute the weaker-than-expected sales performance to the preparation for NRDL inclusion. Recall that Akeso reduced the retail price of AK104 from RMB13,220/125mg to RMB6,610/125mg in Jun 2024. Concurrently, Akeso discontinued the PAP program, a move we believe positions the drug ready for the upcoming NRDL negotiation. Approved in May 2024, Ivonescimab/ AK112 (PD-1/VEGF) realized RMB103mn sales revenue in 1H24. We expect AK104 and AK112 to participate in the NDRL negotiations by end-2024, which will boost their sales upon the inclusion in early 2025. Akeso maintained a high product GP margin at 91.6% in 1H24, compared to 91.8% in FY23. Selling expenses (incl. distribution cost) as % of product sales remained at 56.4% in 1H24, consistent with the 56.3% in FY23. R&D expenses increased 3.4% YoY to RMB594mn in 1H24. Akeso recorded RMB239mn of attributable net loss in 1H24. As of Jun 2024, Akeso had a sufficient cash balance of RMB5.69bn.
2024年上半年，康方生物的營業收入達到了10.3億元人民幣，其中產品銷售額達到了9.39億元人民幣。Cadonilimab/AK104（PD-1/CTLA-4）在2024年上半年的銷售額達到了7.06億元人民幣，同比增長16%，環比下降6%，佔我們之前全年預期的39%。我們將銷售業績不及預期歸因於爲NRDL納入做準備。請回憶康方生物在2024年6月將AK104的零售價格從13,220元/125mg降至6,610元/125mg。與此同時，康方生物停止了PAP計劃，我們認爲這一舉措爲即將到來的NRDL談判做好了準備。2024年5月獲批的Ivonescimab/AK112（PD-1/VEGF）在2024年上半年實現了1.03億元人民幣的銷售收入。我們預計AK104和AK112將於2024年底參與NRDL談判，在2025年初納入將會提振其銷售額。康方生物在2024年上半年保持了高達91.6%的產品毛利率，相比FY23的91.8%。銷售費用（包括配送成本）佔產品銷售額的比例在2024年上半年保持在56.4%，與FY23的56.3%持平。研發費用在2024年上半年同比增長了3.4%，達到了5.94億元人民幣。康方生物在2024年上半年錄得了2.39億元人民幣的淨虧損。截至2024年6月，康方生物的現金餘額爲56.9億元人民幣。
Eyes on readout of the Ph3 H2H trial of AK112 vs Keytruda in 1L PD-L1+ NSCLC at WCLC meeting. Akeso announced that the head-to-head Ph3 China study of AK112 mono vs Keytruda in 1L PD-L1≥1% NSCLC met the PFS superiority endpoint (link 1, link 2), with "a HR significantly better than expected". Following this, an NDA was accepted in Aug 2024 in China with priority review, potentially offering a new chemo-free treatment option for PD- L1+ NSCLC patients. We look forward to the detailed PFS data release of the study at the coming WCLC meeting in Sep, and will monitor the OS data as it matures. Already approved in China for EGFR-TKI resistant nsq-NSCLC, the corresponding MRCT HARMONi trial conducted by Summit is on track to complete enrolment in 2H24. The Ph3 China trial of AK112+chemo vs tislelizumab+chemo in 1L sq-NSCLC is also expected to complete enrolment in 4Q24. Akeso is expanding the indications for AK112, with new Ph3 trials initiated in 1H24 including a Ph3 China trial of AK112+chemo vs durvalumab+chemo for 1L BTC and a Ph3 China trial of AK112+AK117 (CD47) for PD-L1+ HNSCC. A Ph3 trial of AK112+chemo for 1L pancreatic cancer is also in planning.
注意WCLC會議上AK112與Keytruda在1L PD-L1+非小細胞肺癌的Ph3 H2H試驗的結果。康方生物宣佈，AK程一直測獨立與Keytruda對比的中國1L PD-L1≥1%非小細胞肺癌頭對頭第3階段研究已達到PFS優勢終點（鏈接1，鏈接2），並且HR優於預期。隨着這一結果，新藥申報在2024年8月在中國被接受並進行了優先審評，可能爲PD-L1+非小細胞肺癌患者提供一種新的無化療藥物選擇。我們期待在即將到來的9月的WCLC會議上詳細發佈該研究的PFS數據，並將關注隨着數據的成熟，OS數據的進展情況。AK112已在中國獲批用於EGFR-TKI耐藥非鱗基因型非小細胞肺癌，由Summit進行的相應的MRCt HARMONi試驗預計在2024年下半年完成招募。AK112+化療與tislelizumab+化療在1L鱗狀非小細胞肺癌的中國第3階段試驗也預計在2024年第4季度完成招募。康方生物正在擴大AK112的適應症範圍，2024年上半年啓動了幾個新的第3階段試驗，包括AK112+化療與durvalumab+化療用於1L膽管癌的中國第3階段試驗以及AK112+AK117 (CD47)用於PD-L1+頭頸部鱗狀細胞癌的中國第3階段試驗。第1L胰腺癌的AK112+化療試驗也在計劃中。
Rapid progress of indication expansion for AK104. Besides the approved 2/3L CC, Akeso is actively expanding AK104's indications. NDAs of AK104 in 1L GC (submitted in Jan 2024) and 1L CC (submitted in Apr 2024) are currently under review, with the approval expected by end-2024/in 1H25, respectively. Ph3 trials of AK104 in adjuvant HCC, advanced unresectable HCC, PD-L1- NSCLC, and PD-1-resistant 2L GC are ongoing. With an IND filed for AK138D1 (HER3 ADC), and multiple ADC assets in pre-clinical stage expected to enter the clinic, Akeso plans to explore the potential of AK104 or AK112 combined with ADCs to compete with PD-1+chemo.
AK104的適應症擴展進展迅速。除了獲批的2/3L胃癌，康方生物正在積極擴大AK104的適應症範圍。AK104在1L胃癌（2024年1月提交）和1L結直腸癌（2024年4月提交）的新藥申報目前正在審評中，預計將於2024年底/2025年上半年獲得批准。而AK104在輔助性肝細胞癌、晚期不能手術的肝細胞癌、PD-L1-非小細胞肺癌和PD-1耐藥的2L胃癌中的3期臨床試驗正在進行中。同時，康方生物已經提出了AK138D1（HER3 ADC）的IND申請，並預計有多個ADC資產進入臨床前階段，計劃探索AK104或AK112與ADC的聯合應用的潛力與PD-1+化療競爭。
Maintain BUY. We look forward to the detailed data of AK112 at the coming WCLC. Akeso's non-oncology products are nearing commercialization with NDAs for PCSK9 mAb and IL12/23 mAb under review. We expect AK104 and AK112 be covered by NRDL early next year. We revise our TP from HK$59.61 to HK$58.97 (WACC: 10.47%, terminal growth rate: 3.5%).
保持買入。我們期待在即將到來的世界肺癌大會上獲得AK112的詳細數據。康方生物的非腫瘤產品正在接近商業化，PCSK9 mAb和IL12/23 mAb的新藥申報正在審評中。我們預計AK104和AK112將在明年初被納入國家醫保目錄。我們將目標價格從59.61港元下調至58.97港元（加權平均資本成本率：10.47%，終端增長率：3.5%）。
譯文內容由第三人軟體翻譯。
