Q3 2023 Results - Reimagining Medicine
Company overview
Financial review
Conclusions
Appendix
References
Key 2023 readouts for high-value medicines on track
INNOVATION
Key assets* with submission enabling readouts in 2023
KisqaliⓇ
Ph3 NATALEE trial in adjuvant breast
cancer testing broad patient population
(anatomical stage II and III1).
500 iDFS event milestone reached;
data consistent with interim analysis
(March 20232)
Filed in EMA in Q3
FDA regulatory submission planned
in Q4 2023
PluvictoⓇ
PSMAfore trial in mCRPC (post-ARDT,
pre-taxane) positive readout
Detailed data presented at ESMO 2023
FDA regulatory submission
now planned in 2024
Iptacopan
PNH filed with FDA and EMA in Q2 2023
APPLAUSE-IgAN Ph3 met its
pre-specified interim analysis primary
endpoint3 in Q3 2023
APPEAR-C3G Ph3 readout
expected in Q4 2023
Atrasentan
IgAN readout expected in Q4 2023
*Unprobabilized estimated peak sales of all asset indications in late-stage development:
> USD 1bn
> USD 2bn
> USD 3bn
mCRPC metastatic castration resistant prostate cancer. ARDT androgen receptor directed therapy. 1. Based on AJCC prognostic staging. 2. Interim analysis in March 2023, data presented at ASCO 2023. 3. 9 months readout may
support US submission for accelerated approval.
15 Investor Relations | Q3 2023 Results
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