INNOVENT BIOLOGICS(1801.HK):STRONG FUNDAMENTALS ENRICHED BY A WEALTH OF R&D CATALYSTS
INNOVENT BIOLOGICS(1801.HK):STRONG FUNDAMENTALS ENRICHED BY A WEALTH OF R&D CATALYSTS
To cancel the related-party transaction to protect the interests of investors. Innovent previously announced its wholly-owned subsidiary Fortvita would sell 20.39% of shares for a transaction price of US$20.5mn, with the subscribing party being Lostrancos. Dr. Yu Dechao, the Chairman and Executive Director, will hold 82.93% of Lostrancos. Fortvita will serve as Innovent's platform to drive international business, primarily focusing on early-stage pipelines. Due to shareholder concerns regarding this related-party transaction, the Company terminated the transaction on 3 Nov. We believe this move demonstrates Innovent's full respect for the opinions of investors and protects the interests of shareholders. Mgmt. indicates Fortvita currently has no plans for equity financing. We are confident that Innovent will maintain good corporate governance.
爲了保護投資者的利益而取消關聯交易。Innovent先前宣佈其全資子公司Fortvita將以價格爲2050萬美元出售20.39%的股份,認購方爲Lostrancos。虞德超****兼執行董事,將持有Lostrancos 82.93%的股份。Fortvita將作爲Innovent拓展國際業務的平台,主要聚焦早期階段的業務管線。由於股東對這筆關聯交易表示擔憂,公司於11月3日終止了交易。我們認爲這一舉措表明Innovent充分尊重投資者意見,並保護股東利益。管理層表示Fortvita目前沒有股本融資計劃。我們相信Innovent將保持良好的公司治理。
Strong product sales growth continued. In 3Q24, Innovent continued its strong sales momentum, with total product sales increasing 40%+ YoY to more than RMB2.3bn. In 9M24, Innovent recorded more than RMB6.0bn revenue from product sales, representing 74% of our previous full-year estimate, in line with our expectations. According to Eli Lilly, sales of sintilimab in 3Q24 reached a record high of US$150mn (+22% QoQ, +30% YoY), bolstered by broad NRDL coverage. In 9M24, sales of sintilimab were US$390mn (or RMB2.8bn), +39% YoY. We expect sintilimab to maintain its leading position in China and forecast sales of sintilimab to reach RMB3.69bn in 2024E (+34% YoY). The non-IFRS EBITDA loss narrowed significantly to RMB161mn in 1H24 from RMB267mn in 1H23. With fast- growing product sales and consistently improving operating efficiency, we expect Innovent to continue narrowing its loss and to achieve EBITDA breakeven in 2025E.
強勁的產品銷售增長持續。在2024年第三季度,Innovent保持強勁的銷售勢頭,總產品銷售額同比增長40%以上,超過23億元人民幣。2024年前三季度,Innovent從產品銷售中實現超過60億元人民幣的營業收入,佔我們之前全年預估的74%,符合我們的預期。根據禮來公司的數據,2024年第三季度信迪利單抗的銷售額達到1.5億美元(環比增長22%,同比增長30%),得益於廣泛的國家醫保藥品目錄覆蓋。2024年前三季度,信迪利單抗的銷售額爲3.9億元美元(或28億元人民幣),同比增長39%。我們預計信迪利單抗將在中國保持領先地位,並預測2024年其銷售額將達到36.9億元人民幣(同比增長34%)。非IFRS EBITDA虧損從2024年上半年的2.67億元人民幣大幅縮減至1.61億元人民幣。隨着產品銷售的快速增長和運營效率持續改善,我們預計Innovent將繼續縮小虧損並在2025年達到EBITDA盈虧平衡。
Broad commercial portfolio to drive further growth. Innovent's portfolio now includes 11 marketed products, with the approval of taletrectinib (ROS1 TKI) in 2H24, bringing the number of commercial products to 12. Additionally, Innovent has four assets under NDA review, including mazdutide (GLP-1/GCGR, for obesity and diabetes, to be approved in 1H25 and 2H25, respectively), IBI311 (IGF-IR, for thyroid eye disease), limertinib (3G EGFR-TKI, for NSCLC), and IBI112 (IL-23p19, for psoriasis). With a robust portfolio and strong commercial capabilities, mgmt. targets to realize RMB20bn sales in 2027.
廣泛的商業組合將推動進一步增長。Innovent的產品組合現已包括11種上市產品,2024年下半年批准了塔替曲尼(ROS1 TKI),使商業產品數量增至12。此外,Innovent正在進行四個資產的新藥申請審查,包括馬祖肽(GLP-1/GCGR,用於肥胖和糖尿病,分別在2025年上半年和下半年獲批)、IBI311(IGF-IR,用於甲狀腺眼病)、利美替尼(第三代EGFR-TKI,用於非小細胞肺癌)和IBI112(IL-23p19,用於銀屑病)。憑藉強大的產品組合和優秀的商業能力,管理層將目標定爲在2027年實現200億元人民幣的銷售額。
Out-licensing potential for innovative drug candidates. IBI363, a potential FIC PD-1/IL-2 bsAb, has demonstrated encouraging signals in IO-failed and cold tumors, especially in the highly underserved IO-resistant sq-NSCLC. For MSS/pMMR CRC, when combined with bevacizumab, IBI363 showed promising anti-tumor efficacy and tolerability. Furthermore, the FDA awarded IBI363 a fast track designation for melanoma. We anticipate significant out-licensing opportunities for IBI363. Innovent is currently advancing a Ph2 trial of IBI363 across multiple solid tumors in the US. IBI343 (CLDN18.2 ADC) demonstrated encouraging early signals in PDAC, and has received a fast track designation from the FDA for PDAC. Upon successful PoC readout in PDAC, we see substantial out- licensing potential for IBI343. Innovent is conducting a Ph1 trial of IBI343 in the US.
創新藥物候選藥物的外部許可潛力。IBI363是一種潛在的FIC PD-1/IL-2 bsAb,在IO-failed和cold腫瘤中表現出令人鼓舞的信號,特別是在高度未滿足的IO-resistant sq-NSCLC中。對於MSS/pMMR CRC,與bevacizumab聯合使用時,IBI363顯示出有希望的抗腫瘤效果和耐受性。此外,FDA授予IBI363在黑色素瘤方面的快速通道資格。我們預計IBI363將有重要的外部許可機會。康泰正推進IBI363在美國多種實體腫瘤的第2期試驗。IBI343(CLDN18.2 ADC)在PDAC中顯示出令人鼓舞的早期信號,並獲得FDA在PDAC方面的快速通道資格。在PDAC成功PoC結果後,我們看到IBI343存在重大的外部許可潛力。康泰目前正在美國進行IBI343的第1期試驗。
Maintain BUY. Innovent aims to develop its global business, while protecting the interests of its broad shareholder base. We remain confident towards Innovent's strong product sales, improving cost efficiency, and potential of overseas development. We maintain our DCF-based TP unchanged at HK$55.21 (WACC: 10.0%, terminal growth rate: 3.5%).
維持買入。康泰旨在發展其全球業務,同時保護其廣泛股東的利益。我們對康泰強勁的產品銷售、改善成本效率和境外發展潛力保持信心。我們保持基於DCF的目標價不變爲55.21港元(WACC:10.0%,終端增長率:3.5%)。
譯文內容由第三人軟體翻譯。