Q3 2023 Results - Reimagining Medicine
Company overview
Innovation: Pipeline overview
Financial review
Financial performance
2023 expected key events
Conclusions
Appendix
Innovation: Clinical trials
References
Abbreviations
INNOVATION
Regulatory
Cosentyx® HS
decisions
CosentyxⓇ 2ml Al
Cosentyx® IV
Leqvio® Hypercholesterolemia
Submissions
Iptacopan PNH (US/EU/JP)
KisqaliⓇ HR+/HER2- BC (adj)
PluvictoⓇ mCRPC, pre-taxane (US)
Readouts
KisqaliⓇ HR+/HER2-BC (adj)
Iptacopan IgAN
Iptacopan C3G
LutatheraⓇ GEP-NETS
Ph3 starts
Iptacopan in IC-MPGN
H1 2023
EU
H2 2023
US
Status update - as of end Q3
EU approval (Q2)
US
US approval (Q2)
US
US approval (Q3)
JP, China
US/EU
JP
US
US
NATALEE Ph3 FIR
APPLAUSE-IgAN Ph3
APPEAR-C3G Ph3
NETTER-2
Ph3
Leqvio® CVRR primary prevention
Ph3
lanalumab in immune thrombocytopenia
lanalumab in systemic lupus erythematosus
Ph3
Ph3
HS hidradenitis suppurativa. PNH - paroxysmal nocturnal hemoglobinuria.
C3G complement 3 Glomerulopathy.
mCRPC metastatic castration-resistant prostate cancer.
IC-MPGN - immune complex membranoproliferative glomerulonephritis.
Japan and China approval in Q3
Filed in US, EU (Q2), JP (Q3)
Filed in EU in Q3, US submission planned in Q4
US submission expected in 2024
Primary endpoint met at interim analysis;
500 iDFS event milestone reached; data consistent with
interim analysis (March 20231)
Met pre-specified interim analysis primary endpoint in Q3
Met primary endpoint in Q3
APPARENT trial (Q2)
VICTORION-1P (Q1)
1L (VAYHIT1) and 2L (VAYHIT2) FPFV (H1)
SIRIUS-SLE 1 and 2 (Q1)
FIR - first interpretable results.
IgAN-immunoglobulin A nephropathy.
1. Interim analysis in March 2023, data presented at ASCO 2023.
32 Investor Relations | Q3 2023 Results
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