Press Release: Novartis delivers double-digit -2-

in the US and Europe. With supply now unconstrained,

the focus is on opening new sites and referral pathways,

and initiating new patients

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Leqvio (USD 151 million, +139% cc) continued to show steady

growth, with a focus on patient on-boarding, removing

access hurdles and enhancing medical education

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Jakavi (USD 478 million, +18% cc) sales grew in Europe, emerging

growth markets and Japan, driven by strong demand

in both myelofibrosis and polycythemia vera

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Scemblix (USD 136 million, +83% cc) sales grew across all regions,

demonstrating the high unmet need in later lines of

CML

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Xolair (USD 399 million, +15% cc) sales grew across all regions

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Ilaris (USD 356 million, +14% cc) sales grew across all regions,

led by the US and Europe

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Sandostatin (USD 355 million, +9% cc) sales grew mainly in the

Group US

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Tafinlar + (USD 474 million, +5% cc) sales grew in emerging growth

Mekinist markets and Japan, partly offset by a decline in the

US

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Lutathera (USD 169 million, +14% cc) sales grew across all regions

due to increased demand

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Emerging Growth Grew +21% (cc) overall. China grew 31% (cc) to USD

Markets* 1.0 billion, mainly driven by Entresto and Cosentyx

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*All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand

Net sales of the top 20 brands in Q1 2024

Q1 2024 % change

USD m USD cc

------- ---- ----

Entresto 1 879 34 36

-------------------- ------- ---- ----

Cosentyx 1 326 23 25

-------------------- ------- ---- ----

Kesimpta 637 66 66

-------------------- ------- ---- ----

Kisqali 627 51 54

-------------------- ------- ---- ----

Promacta/Revolade 520 -5 -4

-------------------- ------- ---- ----

Jakavi 478 15 18

-------------------- ------- ---- ----

Tafinlar+Mekinist 474 3 5

-------------------- ------- ---- ----

Xolair 399 13 15

-------------------- ------- ---- ----

Tasigna 395 -15 -13

-------------------- ------- ---- ----

Ilaris 356 9 14

-------------------- ------- ---- ----

Sandostatin Group 355 8 9

-------------------- ------- ---- ----

Lucentis 314 -25 -23

-------------------- ------- ---- ----

Pluvicto 310 47 47

-------------------- ------- ---- ----

Zolgensma 295 -5 -3

-------------------- ------- ---- ----

Exforge Group 192 3 5

-------------------- ------- ---- ----

Gilenya 175 -25 -24

-------------------- ------- ---- ----

Lutathera 169 13 14

-------------------- ------- ---- ----

Leqvio 151 136 139

-------------------- ------- ---- ----

Galvus Group 149 -19 -12

-------------------- ------- ---- ----

Diovan Group 140 -11 -7

-------------------- ------- ---- ----

Top 20 brands total 9 341 16 18

-------------------- ------- ---- ----

R&D update - key developments from the first quarter

New approvals

Xolair FDA approval of Xolair for the reduction of allergic

(omalizumab) reactions, including anaphylaxis, that may occur with

accidental exposure to one or more foods in adult

and pediatric patients aged 1 year and older with

IgE-mediated food allergy

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Regulatory updates

Fabhalta Positive CHMP opinion received for Fabhalta for the

(iptacopan) treatment of paroxysmal nocturnal hemoglobinuria (PNH)

patients

FDA filing accepted for the treatment of adult patients

with IgA nephropathy (IgAN), and priority review granted

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Results from ongoing trials and other highlights

Scemblix Phase III ASC4FIRST study met both primary endpoints

(asciminib) (major molecular response rate vs imatinib and vs

investigator-selected tyrosine kinase inhibitors)

with clinically meaningful and statistically significant

results in newly diagnosed patients with Philadelphia

chromosome-positive chronic myeloid leukemia in chronic

phase (Ph+ CML-CP). Additionally, Scemblix showed

a favorable safety and tolerability profile. Data

will be presented at upcoming medical conferences

and submitted to regulatory authorities in 2024

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Fabhalta Phase III APPLAUSE-IgAN data showed a clinically meaningful

(iptacopan) and statistically significant proteinuria reduction

of 38.3% vs placebo for patients with IgA nephropathy

(IgAN). Fabhalta was well tolerated with a favorable

safety profile consistent with previously reported

data. Data presented at WCN 2024

In addition, extension data from the Phase III APPLY-PNH

and APPOINT-PNH studies were presented at EBMT 2024,

demonstrating the sustained long-term efficacy and

safety profile of Fabhalta in PNH patients

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Pluvicto In the Phase III PSMAfore study, updated OS results

from a pre-planned analysis at approximately 75% information

fraction demonstrated an OS HR<1.0 in the intent-to-treat

population unadjusted for cross-over. Novartis is

on track to file for the Pluvicto pre-taxane label

expansion in H2 2024

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Remibrutinib 52-week data from the Phase III REMIX-1 and REMIX-2

studies showed consistent efficacy of remibrutinib

in CSU as early as week 2 and sustained up to 1 year.

Remibrutinib was well tolerated and demonstrated a

consistent, favorable long-term safety profile. Overall

rates of AEs in remibrutinib arms were comparable

to placebo with balanced liver function tests across

both studies. Full data will be presented at an upcoming

medical meeting. Novartis plans to submit remibrutinib

for regulatory approval in H2 2024

In addition, a Phase II trial in hidradenitis suppurativa

demonstrated that remibrutinib (both doses) met the

primary endpoint with patients reporting a greater

rate of simplified HiSCR at week 16 compared with

placebo. Data presented at AAD 2024

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Lutathera Phase III NETTER-2 trial demonstrated that Lutathera

plus octreotide LAR significantly extended median

PFS to 22.8 months vs 8.5 months with high-dose octreotide

LAR alone in patients with newly diagnosed grade 2

and 3 advanced GEP-NETs. No new or unexpected safety

findings were observed. Data presented at ASCO-GI

2024

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Leqvio New data demonstrating the early addition of Leqvio

to maximally tolerated statin therapy in a real-world

setting significantly reduced LDL-C in ASCVD patients,

including those with a history of an ASCVD-related

event, who could not reach their goal on statin therapy

alone. Data presented at ACC 2024 and published in

the Journal of the American College of Cardiology

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Kesimpta ALITHIOS open-label extension study showed sustained

efficacy of first-line, continuous Kesimpta treatment

up to six years in recently diagnosed treatment-naïve

RMS patients, including 44% fewer relapses vs those

who switched later to Kesimpta from teriflunomide.

Kesimpta treatment was also well-tolerated with a

consistent safety profile across the ALITHIOS population.

Data presented at AAN 2024

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Kisqali Results of the Phase III NATALEE study were published

in the New England Journal of Medicine. In the trial,

(MORE TO FOLLOW) Dow Jones Newswires

April 23, 2024 01:00 ET (05:00 GMT)