Novartis Q4 Results
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Achieved our innovation milestones in 2023
10 positive Ph3 readouts for medicines with significant sales potential1
Company overview
Financial review
Conclusions
Appendix
Regulatory
decisions
Cosentyx® HS
Cosentyx® 2ml Al
Cosentyx® IV
FabhaltaⓇ (iptacopan) PNH
Leqvio® Hypercholesterolemia
References
Submissions
Iptacopan PNH (US/EU/JP)
Kisqali® HR+/HER2- BC (adj)
PluvictoⓇ mCRPC, pre-taxane (US)
Atrasentan IgAN
Status update - as of end Q4
EU approval (Q2), US approval (Q4)
US approval (Q2)
US approval (Q4)
US approval (Q4)
Japan and China approval in Q3
Filed in US, EU (Q2), JP (Q3)
Filed in EU in Q3, in US in Q4
10 positive Ph3 readouts
1 KisqaliⓇ eBC NATALEE
2 Iptacopan PNH APPOINT
3 Remibrutinib CSU REMIX-1
4 Remibrutinib CSU REMIX-2
INNOVATION
Readouts
Kisqali® HR+/HER2-BC (adj)
Iptacopan IgAN
Iptacopan C3G
LutatheraⓇ GEP-NETS
Ph3 starts
Remibrutinib CSU
Iptacopan in IC-MPGN
Leqvio® CVRR primary prevention
lanalumab in immune thrombocytopenia
lanalumab in systemic lupus erythematosus
US submission expected in 2024
Met pre-specified interim analysis primary endpoint in Q4
Primary endpoint met at interim analysis; 500 iDFS event milestone reached;
data consistent with interim analysis (March 20232)
Met pre-specified interim analysis primary endpoint in Q3
Met primary endpoint in Q4
Met primary endpoint in Q3
Met primary endpoint in Q4.
APPARENT trial (Q2)
VICTORION-1P (Q1)
1L (VAYHIT1) and 2L (VAYHIT2) (H1)
SIRIUS-SLE 1 and 2 (Q1)
5
LutatheraⓇ GEP-NETS NETTER-2
6 Iptacopan IgAN APPLAUSE
7
PluvictoⓇ mCRPC pre-taxane PSMAfore
8 Atrasentan IgAN ALIGN
9 Iptacopan C3G APPEAR
10 ScemblixⓇ 1L CML ASC4FIRST (Jan 2024)
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HS hidradenitis suppurativa.
C3G
PNH - paroxysmal nocturnal hemoglobinuria.
mCRPC – metastatic castration-resistant prostate cancer.
FIR - first interpretable results.
IgAN immunoglobulin A nephropathy.
complement 3 Glomerulopathy. IC-MPGN - immune complex membranoproliferative glomerulonephritis. 1. Readout or presentations 2. Interim analysis in March 2023, data presented at ASCO 2023.
□ NOVARTIS | Reimagining Medicine.
Novartis Q4 Results | January 31, 2024
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