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APLS JPM 2026 Presentation_for website.pdf

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1、ARCHERLiving with C3G44th Annual J.P.Morgan Healthcare ConferenceCedric Francois,M.D.,Ph.D.Co-Founder,Chief Executive Officer and PresidentJanuary 12,20262Statements in this presentation about future expectations,plans and prospects,as well as any other statements regarding matters that are not hist

2、orical facts,may constitute“forward-looking statements”within the meaning of The Private Securities Litigation Reform Act of 1995.The words“anticipate,”“believe,”“continue,”“could,”“estimate,”“expect,”“intend,”“may,”“plan,”“potential,”“predict,”“project,”“should,”“target,”“will,”“would”and similar e

3、xpressions are intended to identify forward-looking statements,although not all forward-looking statements contain these identifying words.Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,including adjustments to Ap

4、ellis preliminary revenue figures resulting from,among other things,the completion of financial closing and audit procedures for the quarter and year ended December 31,2025;whether the results of the Companys clinical trials for EMPAVELI,SYFOVRE,or any of its future products will warrant regulatory

5、submissions to the FDA or equivalent foreign regulatory agencies and whether the Company will make regulatory submissions when anticipated;whether systemic pegcetacoplan will receive approval from foreign regulatory agencies for C3G and primary IC-MPGN;the rate and degree of market acceptance and cl

6、inical utility of EMPAVELI,SYFOVRE and any future products for which we receive marketing approval will impact our commercialization efforts;whether data from the Companys clinical trials will be available when anticipated;whether results obtained in clinical trials will be indicative of results tha

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1. **核心业务与产品**:Apellis是补体领域领导者,拥有两款获批C3疗法——SYFOVRE®(地理萎缩,GA)和EMPAVELI®(阵发性睡眠性血红蛋白尿症PNH、C3G、原发性IC-MPGN),覆盖4种严重疾病。 2. **财务与增长**:2025年美国净产品收入约$689M(SYFOVRE $587M,EMPAVELI $102M),现金储备$466M,预计现有资金和收入可支撑至盈利。 3. **研发进展**: - SYFOVRE:GA市场领导者(份额~60%),2026年将推出预充针,推进AI工具及下一代疗法(SYFOVRE+APL-3007)。 - EMPAVELI:C3G/IC-MPGN市场渗透率>5%,启动FSGS和DGF关键试验,拓展罕见肾病领域。 - 管线创新:APL-9099(FcRn基因编辑疗法)计划2026年提交IND。 4. **风险提示**:包含前瞻性声明,实际结果可能受临床数据、监管审批、市场接受度等因素影响。
**SYFOVRE市场前景?** **EMPAVELI疗效如何?** **Apellis创新管线进展?**
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