Novartis Investor Presentation
New Novartis: Our strategy
Our focus
Our priorities
Improved financials
Launch excellence
> High-value innovation
Operational excellence
Strengthen foundations
Conclusion
Abbreviations
3. High-value innovation
Potential positive NATALEE readout offers significant upside
to sales growth
KisqaliⓇ Ph3 OS results in 1L mBC
MONALEESA-2
Median OS
Risk reduction 24%
63.9 months1
NATALEE adjuvant study
Ribociclib 400mg/day
3 weeks on/1 week off
RIB+
36 months (-39 cycles)
36 months
60 months
To date not reached first interim;
expect filing in 2023
23
HR++HER2-eBC
ET
MONALEESA-7
R
Pre- and post-
menopausal
1:1
Risk reduction
24%
58.6 months2
Anatomic Stage II
& III
N=5000
ET
MONALEESA-3
Risk reduction
33%
67.6 months3
NSAI 60 months
[+ goserelin in pre-menopausal women & men]
60 months
Indication
Early breast cancer
NSAI 60 months
[+ goserelin in pre-menopausal women & men]
Potential
Population
DOO >USD 1bn
O >USD 2bn
>USD 3bn
■ Proven OS benefit across all three Phase 3
clinical trials
☐
■ Same OS benefit regardless of menopausal status,
hormone therapy partner, or dose modifications4
■ Maintains clinical benefit even after prior CDK4/6i
use5
Fully enrolled as of April 2021
Primary analysis planned at
500 iDFS events, expected in 2023
Interim analyses at 70% and 85%
218K (US & EU)6
1. In months vs. vs 51.4, P value: 0.008. Reference: Hortobagyi, GN et al., 2022 2. vs 51.8. Reference: Lu, YS et al., 2022 3. vs 51.4. Reference: Neven, P et al., 2022 4. Based on an analysis of MONALEESA-2, -3 and -7
the MAINTAIN IIT, Patients who received Kisqali and changed their ET in 2L had PFS twice as long as patients who only changed their ET 6. eBC Patient - Adjuvant Breast Cancer Opportunity Assessment June 2020
5. Based on
Novartis Investor Presentation | September 22, 2022
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