Press Release: Novartis continues strong momentum -2-

Net sales of the top 20 brands in the first quarter

Q1 2025 % change

USD m USD cc

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Entresto 2 261 20 22

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Cosentyx 1 534 16 18

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Kisqali 956 52 56

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Kesimpta 899 41 43

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Tafinlar + Mekinist 552 16 19

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Promacta/Revolade 546 5 8

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Jakavi 492 3 7

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Xolair 456 14 19

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Ilaris 419 18 20

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Tasigna 377 -5 -2

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Pluvicto 371 20 21

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Zolgensma 327 11 13

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Sandostatin Group 317 -11 -9

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Leqvio 257 70 72

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Scemblix 238 75 76

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Lutathera 193 14 15

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Lucentis 189 -40 -38

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Exforge Group 179 -7 -1

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Diovan Group 150 7 12

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Galvus Group 124 -17 -11

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Top 20 brands total 10 837 17 19

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R&D update - key developments from the first quarter

New approvals

Pluvicto FDA expanded the indication for Pluvicto to include

(lutetium Lu177 vipivotide tetraxetan) patients with PSMA-positive metastatic castration-resistant

prostate cancer (mCRPC) who have been treated with

an androgen receptor pathway inhibitor and are considered

appropriate to delay chemotherapy, approximately tripling

the eligible patient population.

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Vanrafia FDA granted an accelerated approval for Vanrafia for

(atrasentan) the reduction of proteinuria in adults with primary

immunoglobulin A nephropathy (IgAN) at risk of rapid

disease progression. Vanrafia can be seamlessly added

to supportive care in IgAN and used as a foundational

therapy.

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Fabhalta Fabhalta was approved by the US FDA, European Commission

(iptacopan) and China's NMPA for adult patients with C3 glomerulopathy

(C3G), making it the first and only treatment approved

for this condition in all three markets.

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Regulatory updates

Remibrutinib Regulatory submissions for remibrutinib for the treatment

of chronic spontaneous urticaria (CSU) were completed

in the US, EU and China. A priority review voucher

was used in the US and approval is anticipated in

H2 2025, and priority review was granted in China.

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Scemblix Regulatory submission for Scemblix in adults with

(asciminib) newly diagnosed CML was completed in the EU based

on 96-week data from the Phase III ASC4FIRST study.

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Results from ongoing trials and other highlights

OAV101 IT Novartis announced positive safety and efficacy results

(onasemnogene from the Phase III program for investigational intrathecal

abeparvovec) OAV101 IT in a broad population of patients aged two

to <18 years with spinal muscular atrophy (SMA). In

the Phase III STEER study, treatment with OAV101 IT

led to a statistically significant and clinically

meaningful 2.39-point improvement on the Hammersmith

Functional Motor Scale Expanded vs. 0.51 points in

the sham control arm. In addition, in the Phase IIIb

STRENGTH study, treatment with OAV101 IT in patients

who have discontinued treatment with nusinersen or

risdiplam demonstrated stabilization of motor function

over 52 weeks of follow-up. OAV101 IT demonstrated

a favorable safety profile, consistent in both treatment-naïve

and treatment-experienced patients. Data were presented

at MDA.

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Remibrutinib The New England Journal of Medicine published data

from the 24-week double-blind placebo-controlled period

of the Phase III REMIX-1 and -2 studies. Remibrutinib

showed early symptom improvement and sustained efficacy,

with improvements in CSU symptoms compared to placebo

observed as early as week 1 and response rate maintained

through the double-blind treatment period. Remibrutinib

was well tolerated, with overall adverse event rates

comparable to placebo.

Multiple analyses of the REMIX-1 and -2 trials were

presented at medical congresses in Q1. At AAAAI, long-term

results showed that patients experienced improved

urticaria control within two weeks of starting treatment.

Patients who switched from placebo to remibrutinib

at week 24 achieved similar improvements through week

52. At AAD, data was presented showing that treatment

with remibrutinib had positive effects on sleep and

daily activities for CSU patients.

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Ianalumab The results of Phase II VAYHIT3 study in adult patients

with advanced primary ITP, previously treated with

at least a corticosteroid and a thrombopoietin receptor

agonist, indicate that a short course of ianalumab

has clinically meaningful efficacy and is well tolerated

in these patients. These results will be presented

at a future medical meeting and are expected to support

a filing in second-line ITP, based on the Phase III

VAYHIT2 study, expected to read out in H2 2025.

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Selected Novartis has completed the acquisition of Anthos Therapeutics,

transactions a clinical-stage biopharmaceutical company developing

abelacimab, a potential first-in-class monoclonal

antibody targeting the FXI inhibition pathway in development

for the prevention of stroke and systemic embolism

in patients with atrial fibrillation. The acquisition

adds a Phase III asset and is aligned with the Novartis

growth strategy and expertise in the cardiovascular

therapeutic area.

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Capital structure and net debt

Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

In Q1 2025, Novartis repurchased a total of 24.8 million shares for USD 2.6 billion on the SIX Swiss Exchange second trading line under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 2.7 billion still to be executed). In addition, 1.5 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 10.5 million shares (equity value of USD 0.3 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the dilutive impact from equity-based compensation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 15.8 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 2.5 billion and a net cash outflow of USD 2.7 billion.

Net debt increased to USD 22.3 billion at March 31, 2025, compared with USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 3.4 billion being more than offset by the USD 5.3 billion annual net dividend payment in March (which is the gross dividend of USD 7.8 billion reduced by the USD 2.5 billion Swiss withholding tax that was paid in April 2025, according to its due date), cash outflows for treasury share transactions of USD 2.7 billion and cash outflows for purchases of intangible assets of USD 1.2 billion.

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April 29, 2025 01:00 ET (05:00 GMT)