INNOVENT BIOLOGICS(1801.HK):MORE THAN OBESITY
INNOVENT BIOLOGICS(1801.HK):MORE THAN OBESITY
Strong product sales in FY23. In FY23, Innovent recorded total revenue of RMB6.21bn, including RMB5.73bn product sales revenue (+38.4% YoY), in line with our expectation. Innovent had a strong 2H23, with product sales +33.1% HoH vs the first half. As per Eli Lilly, total sales of sintilimab in FY23 reached US$393.3mn (RMB2.75bn), +34.0% YoY, thanks to the extension of NRDL coverage with stable pricing. We forecast sales of sintilimab to reach RMB3.29bn in 2024E (+19% YoY) and expect the drug to maintain its leading position in China's PD-(L)1 market.
23 財年產品銷售強勁。在23財年，信達的總收入爲人民幣62.1億元，其中包括人民幣57.3億元的產品銷售收入（同比增長38.4％），符合我們的預期。信達生物在23年下半年表現強勁，產品銷售額較上半年增長33.1％。根據禮來公司的數據，23財年辛替利單抗的總銷售額達到3.933億美元（人民幣27.5億元），同比增長34.0％，這要歸功於NRDL覆蓋範圍的擴大和穩定的價格。我們預計辛替利單抗的銷售額將在2024E達到32.9億元人民幣（同比增長19％），並預計該藥物將保持其在中國PD-（L）1市場的領先地位。
Sharp decrease in EBITDA loss thanks to improving cost efficiency. The non- IFRS EBITDA loss narrowed significantly by 73% YoY to RMB600mn in FY23. With fast-growing product sales and consistently improving operating efficiency, Mgt. is confident to achieve EBITDA breakeven in 2025E. Innovent's gross margin on product sales reached 80.7% in 2H23 (vs 79.5% in 1H23 and 77.5% in 2022). SG&A ratio dropped to 60.9% in 2H23 from 63.5% in 1H23. FY23 R&D expenses decreased 22.4% YoY to RMB2.23bn, while Mgt. expects steady R&D expenses in FY24. As of end-2023, Innovent had a strong cash balance of RMB11.0bn.
由於提高了成本效率，息稅折舊攤銷前利潤損失急劇下降。非國際財務報告準則息稅折舊攤銷前利潤虧損在23財年同比大幅縮小73％至6億元人民幣。隨着產品銷售的快速增長和運營效率的持續提高，Mgt. 有信心在2025E實現息稅折舊攤銷前利潤收支平衡。信達的產品銷售毛利率在23年下半年達到80.7％（相比之下，23年上半年爲79.5％，2022年爲77.5％）。銷售和收購比率從23年上半年的63.5％降至23年下半年的60.9％。23財年的研發費用同比下降22.4％，至人民幣22.3億元，而管理部預計24財年的研發費用將保持穩定。截至2023年底，信達擁有110億元人民幣的強勁現金餘額。
Expect positive PoC data release for CLDN18.2 ADC. Innovent has a rich portfolio of clinical-stage ADC assets, including ADCs targeting CLDN18.2, HER2, HER3, B7H3, and TROP2. Several bi-specific ADCs will enter clinical trials this year, including the EGFR/B7H3 ADC. IBI343 (CLDN18.2 ADC) is leading global development of CLDN18.2 ADC with BIC potential. Innovent plans to start a Ph3 MRCT trial (NCT06238843) of IBI343 in 3L GC shortly, following in the footsteps of AstraZeneca/Keymed's CMG901, which recently launched a Ph3 MRCT in 2L+ GC (CTR20240730). Positive Ph1b PoC data for IBI343 in gastric cancer are anticipated to be released in 2024, along with initial PoC data in pancreatic cancer. Innovent is also exploring the potential of IBI343 in combo with its own PD-1 sintilimab and VEGFR-2 ramucirumab for 1L and 2L GC. We think IBI343 has global BIC potential due to its superior safety and satisfying efficacy. IBI343's RP2D dose is as high as 6mg/kg, suggesting a broad therapeutic window.
預計 CLDN18.2 ADC 將發佈積極的 PoC 數據。信達擁有豐富的臨床階段 ADC 資產組合，包括針對 CLDN18.2、HER2、HER3、B7H3 和 TROP2 的 ADC。今年將有幾種雙特異性ADC進入臨床試驗，包括EGFR/B7H3 ADC。IBI343（CLDN18.2 ADC）是全球領先的具有 BIC 潛力的 CLDN18.2 ADC 的開發。信達計劃緊隨阿斯利康/KeyMed 的 CMG901 的腳步，在 3L 氣相色譜中啓動 IBI343 的 Ph3 MRCT (NCT06238843) 試驗 ()，後者最近推出了 2L+ GC (CTR20240730) 的 Ph3 MRCT 試驗。胃癌 IBI343 的 pH1b PoC 陽性數據預計將於 2024 年公佈，胰腺癌的初始 PoC 數據也將公佈。信達生物還在探索 IBI343 與自己的 PD-1 sintilimab 和 VEGFR-2 ramucirumab 聯合用於 1L 和 2L GC 的潛力。我們認爲，由於其卓越的安全性和令人滿意的療效，IBI343 具有全球 BIC 潛力。IBI343 的 RP2D 劑量高達 6mg/kg，這表明治療窗口很廣。
Moving from global BIC to FIC. IBI363 is a prospective FIC PD-1/IL-2 bsAb with a differentiated α-biased IL-2 arm, distinct from other IL-2 mAbs that eliminate the receptor α (link). IBI363 showed promising efficacy signals in IO-resistant and cold tumours. We expect Innovent to release positive PoC data of IBI363 in IO-resistant melanoma, NSCLC, and 3L+ CRC in 2024. Innovent plans to start a Ph2 study of IBI363 in the US in 2024. In addition, many innovative bi/tri-specific antibodies have entered clinic, including CLDN18.2/CD3, EGFR/B7H3, GPRC5D/BCMA/CD3, etc.
從全球 BIC 遷移到 FIC。IBI363 是一種前瞻性 FIC PD-1/IL-2 bsAb，具有差異化的 α 偏向 IL-2 組，不同於其他消除受體 α 的 IL-2 單克隆抗體（鏈接）。IBI363 在 IO 耐藥腫瘤和冷腫瘤中顯示出令人鼓舞的療效信號。我們預計，信達生物將在2024年發佈抗IO黑色素瘤、非小細胞肺癌和3L+結直腸癌中 IBI363 的陽性 PoC 數據。信達計劃於 2024 年在美國啓動 IBI363 的二期研究。此外，許多創新的雙/三特異性抗體已進入臨床，包括CLDN18.2/CD3、EGFR/B7H3、GPRC5D/BCMA/CD3等。
Multiple blockbuster non-oncology assets. Besides the blockbuster product mazdutide (GLP-1R/GCGR), which is under NDA review in China for obesity since Feb 2024, Innovent has multiple blockbuster non-oncology assets. IBI112, an IL- 23p19 antibody, is expected to release the Ph3 data in psoriasis and submit NDA in 2024. In the Phase 2 study, at week 52, up to 86% of patients in the IBI112 arm achieved PASI90, a result comparable to the 84% for guselkumab (another IL- 23p19 mAb) and superior to the 70% for secukinumab (an IL-17 mAb) at week 48 (link). With a dosing interval of 12 weeks compared to guselkumab's 8 weeks, IBI112 shows BIC potential for psoriasis treatment. We believe IBI328 (XOI) and IBI311 (IGF-1R) also have blockbuster potential.
多項重磅非腫瘤學資產。除了自2024年2月起在中國接受肥胖問題保密協議審查的重磅產品mazdutide（GLP-1R/GCGR）外，信達還擁有多項重磅非腫瘤學資產。IBI112 是一種IL-23p19抗體，預計將在2024年發佈牛皮癬的Ph3數據並提交保密協議。在第 52 周的 2 期研究中，IBI112 組中多達 86% 的患者獲得了 PASI90，這一結果與 guselkumab（另一種IL-23p19 單抗）的 84% 相當，高於第 48 周的 secukinumab（一種 IL-17 單抗）的 70%（鏈接）。IBI112 的給藥間隔爲 12 周，而 guselkumab 的給藥間隔爲 8 周，顯示出 BIC 在牛皮癬治療中的潛力。我們認爲，IBI328（XOI）和 IBI311（IGF-1R）也有巨大的潛力。
Maintain BUY. We revise our DCF-based TP from HK$57.35 to HK$55.00 (WACC: 10.3%, terminal growth rate: 4.0%)
維持買入。我們將基於差價合約的目標股價從57.35港元上調至55.00港元（WACC：10.3%，終端增長率：4.0%）
譯文內容由第三人軟體翻譯。