INNOVENT BIOLOGICS(1801.HK):2025 EBITDA BREAKEVEN GOAL UNCHANGED
INNOVENT BIOLOGICS(1801.HK):2025 EBITDA BREAKEVEN GOAL UNCHANGED
Strong product sales growth continued. In 1H24, Innovent recorded total revenue of RMB3.95bn, including RMB3.81bn product sales (+55% YoY, +17% HoH), representing 53% of our previous full-year estimate, surpassing our expectations. The strong product sales growth was mainly driven by the sintilimab and other new products. According to Eli Lilly, sales of sintilimab in 1H24 reached US$240mn (or RMB1.71bn), +46% YoY, bolstered by expanded NRDL coverage and stable pricing. We forecast sales of sintilimab to reach RMB3.55bn in 2024E (+29% YoY).
強勁的產品銷售增長持續。2024年上半年，信達錄得總營業收入39.5億元人民幣，其中產品銷售達到38.1億元人民幣（+55%同比，+17%環比），佔我們先前全年預期的53%，超出我們的預期。強勁的產品銷售增長主要受賽立普單抗和其他新產品推動。根據禮來公司數據，2024年上半年賽立普單抗銷售額達2.4億美元（或17.1億元人民幣），同比增長46%，受到國家醫保藥品目錄擴 coverage 和穩定的定價的支持。我們預計2024年賽立普單抗銷售額將達到35.5億元人民幣（+29%同比）。
EBITDA loss significantly narrowed thanks to improving cost efficiency. The non-IFRS EBITDA loss narrowed significantly from RMB267mn in 1H23 to RMB161mn in 1H24. With fast-growing product sales and consistently improving operating efficiency, mgt. is confident to achieve breakeven on EBITDA in 2025E. Under IFRS, Innovent's gross margin on product sales increased by 3.5ppt to 82.2% in 1H24 (vs 79.5% in 1H23). SG&A ratio dropped to 55.6% in 1H24 from 63.5% in 1H23. R&D expenses were RMB1.40bn in 1H24, +7% HoH. The mgt. expects steady R&D expenses in 2H24. As of Jun 2024, Innovent reported a strong cash balance of RMB10.11bn.
由於成本效率的提高，EBITDA虧損大幅縮減。根據非IFRS標準，2023年上半年EBITDA虧損由2.67億元人民幣減少至1.61億元人民幣。隨着產品銷售快速增長和持續改善的運營效率，管理層相信2025年EBITDA將實現盈虧平衡。根據IFRS，信達的產品銷售毛利率在2024年上半年提高了3.5個百分點，達到82.2%（而2023年上半年爲79.5%）。銷售及管理費用佔營業收入比率從2023年上半年的63.5%降至2024年上半年的55.6%。2024年上半年研發費用爲14億元人民幣，環比增長7%。管理層預計2024年下半年研發費用將保持穩定。截至2024年6月，信達的現金餘額爲101.1億元人民幣。
To establish a strong CVM portfolio. Innovent's portfolio now includes 10 marketed products, recently bolstered by the approval of fulzerasib, a KRAS G12C inhibitor for 2L NSCLC. We anticipate approval for taletrectinib (ROS1 TKI) in 2H24 for 2L NSCLC, with an NDA for the 1L indication submitted in Mar 2024. In the cardiovascular and metabolic (CVM) space, we expect mazdutide (GLP-1R/GCGR) to receive approval for obesity in 1H25 (NDA in Feb 2024) and for diabetes in 2H25 (NDA in Aug 2024). We are optimistic about mazdutide's further development in adolescent obesity, MASH, OSA, and heart failure. The NDA for IBI311 (IGF-IR) for thyroid eye disease is currently under review. We expect Innovent to establish a strong portfolio in CVM sector, with its marketed product Sintbilo (PCSK9) and late- stage pipelines including mazdutide, IBI311 (IGF-IR), IBI128 (XOI), etc.
建立強大的CVm產品組合。信達目前的產品組合包括10個已上市產品，最近批准的富列替尼適用於2L NSCLC的KRAS G12C 抑制劑，進一步增強了產品組合。我們預計2H24富列替尼（ROS1 TKI）將獲得適用於2L NSCLC的批准，在2024年3月提交了1L適應症的新藥申請。在心血管和代謝（CVM）領域，我們預計馬曲替德（GLP-1R/GCGR）將在2025年上半年獲得肥胖症的批准（2024年2月提交新藥申請），並在2025年下半年獲得糖尿病的批准（2024年8月提交新藥申請）。我們對馬曲替德在青少年肥胖症、MASH、OSA和心力衰竭方面的進一步發展持樂觀態度。目前，IBI311（IGF-IR）用於甲狀腺眼病的新藥申請正在接受審查。我們預計信達將通過其上市產品信必絡（PCSK9）和包括馬曲替德、IBI311（IGF-IR）、IBI128（XOI）等在內的後期產品線，在CVm領域建立強大的產品組合。
IBI363 has global blockbuster potential. IBI363, a potential FIC PD-1/IL-2 bsAb, has demonstrated encouraging signals in IO-failed and cold tumors, especially in IO-resistant sq-NSCLC. For later-line IO-treated sq-NSCLC patients (n=37) receiving IBI363 at ≥0.3mg/kg, the ORR reached 35.1% and the mPFS reached 5.5 months, much better than the SoC docetaxel's 12.7% ORR and 3.9 months of mPFS (link). We anticipate updated data to be presented at the upcoming WCLC meeting in September, particularly for the 3 mg/kg Q3W dosing regimen. Updated data in CRC will be presented at the coming ESMO meeting. Innovent also started a Ph2 basket trial of IBI363 in the US. Additionally, IBI343 (CLDN18.2 ADC) demonstrated encouraging signals in the highly underserved PDAC, with 40.0% ORR observed in the 10 CLDN18.2 positive (≥60%) PDAC patients at the 6mg/kg dose. IBI343 has received a fast track designation from the FDA. A Ph3 trial of IBI343 in 3L GC is in preparation, and Innovent plans to start Ph1 trials of IBI343 in the US. Furthermore, Innovent has multiple ADC assets at early clinical stage, targeting EGFR/B7H3, B7H3, TROP2, HER3, etc.
IBI363具有全球超級暢銷潛力。IBI363是一種潛在的FIC PD-1/IL-2 bsAb，在IO-failed和cold tumors中表現出令人鼓舞的信號，尤其是在IO-resistant sq-NSCLC中。對接受≥0.3mg/kg IBI363的晚期IO-treated sq-NSCLC患者（n=37），ORR達到35.1％，mPFS達到5.5個月，遠遠優於SoC docetaxel的12.7％的ORR和3.9個月的mPFS（鏈接）。我們預計將在即將舉行的9月WCLC會議上公佈更新的數據，尤其是針對3 mg/kg Q3W劑量方案的數據。關於CRC的更新數據將在即將舉行的ESMO會議上公佈。Innovent還在美國開展了Ph2的IBI363籃試驗。此外，IBI343（CLDN18.2 ADC）在高度不足的PDAC中展現出令人鼓舞的信號，10例CLDN18.2陽性（≥60％）PDAC患者在6mg/kg劑量下的ORR達到40.0％。IBI343已獲得FDA的快速通道認定。正在籌備IBI343在3L GC中的Ph3試驗，Innovent計劃在美國開始IBI343的Ph1試驗。此外，Innovent還擁有多個早期臨床階段的ADC資產，目標是EGFR/B7H3，B7H3，TROP2，HER3等。
Maintain BUY. We are confident towards Innovent's EBITDA breakeven target in 2025 and see FIC potential of the innovative PD-1/IL-2 asset. We revise our DCF- based TP from HK$55.75 to HK$55.21 (WACC: 10.0%, terminal growth rate: 3.5%).
維持買入評級。我們對Innovent在2025年實現EBITDA盈虧平衡目標充滿信心，並看好創新PD-1/IL-2資產的FIC潛力。我們將基於DCF的目標價從HK$55.75調整爲HK$55.21（WACC：10.0％，無窮增長率：3.5％）。
譯文內容由第三人軟體翻譯。