AKESO BIOTECH(09926.HK):CONTINUOUS SALES RAMP UP WITH R&D ACHIEVEMENTS
AKESO BIOTECH(09926.HK):CONTINUOUS SALES RAMP UP WITH R&D ACHIEVEMENTS
Akeso announced 2023 revenue of Rmb4.5bn (+440% YoY) and net profit of Rmb2.0bn (vs net losses of Rmb1.2bn in 2022), in line with our expectation. The strong revenue growth is mainly due to the upfront payments of Rmb2.9bn from Summit Therapeutics for ivonescimab (AK112, PD-1/VEGF) and the sales ramp up of cadonilimab (AK104), reaching Rmb1.4bn in 2023. Its R&D expenses reached Rmb1.3bn (-5% YoY) and selling expenses reached Rmb890m (+61% YoY) in 2023. As of end-2023, the company has sufficient cash of Rmb4.9bn on hand. Considering the R&D investments and marketing expenses for new products, we lower our EPS forecast from -Rmb0.22 to -Rmb0.41 in 24E, from Rmb0.55 to Rmb0.53 in 25E, and forecast Rmb2.05 in 26E. Based on the DCF model, we raise our target price from HK$56 to HK$60. With 21% upside, we maintain our BUY rating.
Akeso宣佈2023年收入爲45億元人民幣（同比增長440％），淨利潤爲20億元人民幣（而2022年的淨虧損爲12億元人民幣），符合我們的預期。強勁的收入增長主要是由於Summit Therapeutics爲依文西單抗（AK112，PD-1/VEGF）預付了29億元人民幣，以及卡多尼利單抗（AK104）的銷售增長，到2023年達到14億元人民幣。2023年，其研發費用達到13億元人民幣（同比下降5％），銷售費用達到8.9億元人民幣（同比增長61％）。截至2023年底，該公司手頭有足夠的49億元現金。考慮到研發投資和新產品的營銷費用，我們將24E的每股收益預測從0.22元人民幣下調至-0.41元人民幣，下調25E的每股收益預測從0.55元人民幣下調至0.53元人民幣，並預測26E的每股收益爲2.05元人民幣。根據差價合約模型，我們將目標價從56港元上調至60港元。上行空間爲21％，我們維持買入評級。
Strong sales performance of cadonilimab (AK104). Sales of cadonilimab (AK104) reached Rmb1.4bn (+149% YoY) in 2023. Cadonilimab has been included into c.10 clinical guidelines and expert consensus. Meanwhile, AK104 has been included in the commercial insurance of 15 provinces and c.70 cities, which may further increase its affordability. Besides, clinical trials of cadonilimab have covered 16 indications, including lung cancer, liver cancer, gastric cancer, cervical cancer, etc. In addition, the company submitted the NDA for cadonilimab's combo with chemo as the 1L treatment of unresectable, locally advanced, recurrent or metastatic G/GEJ adenocarcinoma in January 2024. In addition, the phase III clinical trial of cadonilimab's combo with chemo with or without bevacizumab as the 1L treatment for persistent, recurrent or metastatic CC achieved the primary endpoint of PFS in the interim analysis.
卡多尼利單抗（AK104）的強勁銷售業績。2023年，卡多尼利單抗（AK104）的銷售額達到14億元人民幣（同比增長149％）。卡多尼利單抗已被納入c.10臨床指南和專家共識。同時，AK104 已被納入15個省份和大約70個城市的商業保險，這可能會進一步提高其可負擔性。此外，卡多尼利單抗的臨床試驗已涵蓋16種適應症，包括肺癌、肝癌、胃癌、宮頸癌等。此外，該公司於2024年1月提交了卡多尼利單抗與化療組合作爲不可切除的、局部晚期、復發或轉移的G/GEJ腺癌的1L治療的保密協議。此外，卡多尼利單抗聯合化療的III期臨床試驗在中期分析中達到了PFS的主要終點，包括或不使用貝伐珠單抗作爲持續性、複發性或轉移性CC的1L療法。
Overseas development of ivonescimab (AK112, PD-1/VEGF) on track. The NDA of AK112's combo with chemo for EGFR mutation nsq-NSCLC patients after EGFR-TKI treatment, has been accepted by the CDE in August of 2023. In addition, AK112 is under six phase III trials for NSCLC, including mono vs pembrolizumab for 1L PD-L1+ NSCLC patients, and combo with chemo vs tislelizumab's combo with chemo for 1L locally advanced or metastatic sq-NSCLC. Apart from the lung cancer, AK112 is under development for other indications, such as GC, BC, HCC, etc. In terms of the AK112's development in overseas market, Summit Therapeutics announced two global phase III trials in 2023, including AK112's combo with chemo in patients with EGFR-mutated, locally advanced or metastatic nsq-NSCLC who have progressed after treatment with a third-generation EGFR-TKI (HARMONi), and AK112's combo with chemo vs pembrolizumab with chemo for 1L sq-NSCLC (HARMONi-3).
依文西單抗（AK112，PD-1/VEGF）的海外開發步入正軌。對於表皮生長因子-TKI治療後的表皮生長因子突變nsq-NSCLC患者，AK112 與化療組合的保密協議已於2023年8月被CDE接受。此外，AK112 正在進行六項非小細胞肺癌三期試驗，包括針對1L PD-L1+ NSCLC患者的單抗與派姆珠單抗，以及聯合化療對比替雷利珠單抗聯合化療治療1L局部晚期或轉移性SQ-NSCLC。除肺癌外，AK112 正在開發用於其他適應症，例如 GC、BC、HCC 等。就 AK112 在海外市場的發展而言，Summit Therapeutics 於 2023 年宣佈了兩項全球 III 期試驗，包括對錶皮生長因子突變、局部晚期或轉移性 nsq-NSCLC 患者進行的 AK112 聯合化療，這些患者在接受第三代 EGFR-TKI (Harmoni) 治療後出現進展的表皮生長因子突變、局部晚期或轉移性非小細胞肺癌患者，還有 AK112 針對1L SQ-nsclc（Harmoni-3）的化療組合對比 pembrolizumab 加化療。
Non-oncology pipeline entering into commercialization stage. The company has submitted the NDA for ebronucimab (PCSK9, AK102) for treatment of essential hypercholesterolemia and mixed hypercholesterolemia and HeFH and ebdarokimab (IL-12/IL-23, AK101) for treatment of moderate-to- severe plaque psoriasis in 2023. In addition, as for the other pipeline of autoimmune diseases, phase III trial of AK111 (IL-17) for the treatment of moderate-to severe plaque psoriasis reached all efficacy endpoints and AK120 (IL-4R) is under phase II trial for the treatment of moderate-to-severe atopic dermatitis. In addition, Akeso's other four bispecific products are entering clinical stage, including AK129(PD-1/LAG-3), AK130(TIGIT/TGF-β), AK131(PD-1/CD73) and AK132(claudin18.2/CD47).
非腫瘤學產品線進入商業化階段。該公司已於2023年提交了用於治療原發性高膽固醇血癥和混合性高膽固醇血癥的依布羅努西單抗（PCSK9，AK102）以及用於治療中度至重度斑塊狀銀屑病的HefH和依布達羅基單抗（IL-12/IL-23，AK101）的保密協議。此外，至於其他自身免疫性疾病，用於治療中度至重度斑塊狀牛皮癬的 AK111 (IL-17) 的三期試驗已達到所有療效終點，用於治療中度至重度特應性皮炎的 AK120 (IL-4R) 正在進行二期試驗。此外，Akeso的其他四種雙特異性產品正進入臨床階段，包括 AK129（PD-1/LAG-3）、AK130（Tigit/TGF-β）、AK131（PD-1/CD73）和 AK132（Claudin18.2/CD47）。
Maintain BUY. Considering the R&D investments and marketing expenses for new products, we lower our EPS forecast from -Rmb0.22 to -Rmb0.41 in 24E, from Rmb0.55 to Rmb0.53 in 25E, and forecast Rmb2.05 in 26E. Based on the DCF model, we raise our target price from HK$56 to HK$60. With 21% upside, we maintain our BUY rating.
維持買入。考慮到研發投資和新產品的營銷費用，我們將24E的每股收益預測從0.22元人民幣下調至-0.41元人民幣，下調25E的每股收益預測從0.55元人民幣下調至0.53元人民幣，並預測26E的每股收益爲2.05元人民幣。根據差價合約模型，我們將目標價從56港元上調至60港元。上漲幅度爲21％，我們維持買入評級。
Risks: R&D failure of key pipeline; lower-than-expected sales of key commercialized products.
風險：關鍵產品研發失敗；關鍵商業化產品的銷售低於預期。
譯文內容由第三人軟體翻譯。