Press Release: Novartis delivers strong sales -2-


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120.00 EUR -0.04 EUR -0.03 %

uptake demonstrating the high unmet need in CML

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Leqvio (USD 64 million) launch progressing steadily including

expansion into new geographies

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Jakavi (USD 414 million, +13% cc) sales grew in Emerging

Growth Markets, Europe and Japan, driven by strong

demand in both myelofibrosis and polycythemia vera

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Piqray (USD 116 million, +61% cc) sales grew mainly in the

US, benefiting from indication expansion into PIK3CA-related

overgrowth spectrum (PROS)

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Lutathera (USD 149 million, +22% cc) sales grew mainly in the

US and Japan due to increased demand

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Cosentyx (USD 1,076 million, -4% cc) continued demand growth

across key geographies, offset by revenue deduction

adjustments in the US. Ex-US sales grew +17% (cc)

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Sandoz (USD 518 million, +17% cc) driven by ex-US growth

Biopharmaceuticals

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Emerging Growth Overall, grew +14% (cc). China returned to growth

Markets* post COVID lockdowns. (+1% cc, USD 829 million), with

Innovative Medicines growing +5%

*All markets except the US, Canada, Western Europe,

Japan, Australia, and New Zealand

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Net sales of the top 20 Innovative Medicines products in Q1 2023

Q1 2023 % change

USD m USD cc

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

Entresto 1 399 28 32

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Cosentyx 1 076 -7 -4

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Promacta/Revolade 547 11 15

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Tasigna 462 0 4

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Tafinlar + Mekinist 458 14 18

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Lucentis 416 -20 -15

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Kisqali 415 74 81

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Jakavi 414 6 13

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Kesimpta 384 97 100

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Xolair 354 -4 2

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Sandostatin 329 3 5

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Ilaris 328 15 19

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Zolgensma 309 -15 -14

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Gilenya 232 -62 -60

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Pluvicto 211 nm nm

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Exforge Group 186 -7 -1

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Galvus Group 183 -15 -9

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Diovan Group 158 -17 -11

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Lutathera 149 19 22

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Gleevec/Glivec 147 -26 -21

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Top 20 products total 8 157 4 8

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nm= not meaningful

R&D update - key developments from the first quarter

New approvals

Pluvicto In April FDA approved Millburn facility for commercial

production of Pluvicto. Expected to contribute meaningfully

to supply in Q3 after the anticipated approval of

additional lines

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Tafinlar + Approved in the US for the treatment of pediatric

Mekinist patients >=1 year of age with low-grade glioma with

a BRAF V600E mutation who require systemic therapy

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Hyrimoz FDA approved biosimilar Hyrimoz (adalimumab-adaz)

(adalimumab) high-concentration formulation to treat seven indications

covered by the reference medicine, Humira(R)

EC approved (April 3, 2023) citrate-free high concentration

formulation of adalimumab biosimilar to treat all

indications covered by the reference medicine, Humira(R)

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Regulatory updates

Entresto Positive CHMP opinion for pediatric heart failure

indication. If approved, this would support extension

of regulatory data protection in Europe to November

2026

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Denosumab biosimilar FDA accepted BLA for proposed biosimilar denosumab.

The application includes all indications covered by

the reference medicines Prolia(R) and Xgeva(R)

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Results from ongoing trials and other highlights

Kisqali Ph3 NATALEE trial met its primary endpoint (iDFS)

at an interim analysis. Kisqali plus ET significantly

reduced the risk of disease recurrence, compared to

ET alone, demonstrating consistent benefit in a broad

population of patients with stage II and III HR+/HER2-

early breast cancer, including those with no nodal

involvement. Data will be presented at an upcoming

meeting and submitted to regulatory authorities

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Cosentyx Long-term data from the pivotal SUNSHINE and SUNRISE

trials evaluating Cosentyx in moderate-to-severe HS,

demonstrated continued improvement in treatment response

rates with over 55% of patients achieving a HiSCR

at Week 52 and over 50% of patients demonstrating

a meaningful reduction in pain. Data published in

Lancet and presented at the 2023 AAD annual meeting

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Zolgensma Data from two long-term follow-up studies, LT-001

and LT-002, show continued efficacy and durability

of Zolgensma up to 7.5 years post-dosing, across a

range of patient populations, with an overall benefit-risk

profile that remains favorable. All pre-symptomatic

children treated maintained or achieved all assessed

motor milestones. Data presented at the 2023 MDA conference

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R&D Portfolio Prioritization Novartis continues to focus its R&D portfolio prioritizing

high value medicines with transformative potential

for patients. During the quarter, a comprehensive

review of R&D projects resulted in decisions to discontinue

or out-license projects for reasons including strategic

fit and commercial potential, representing approximately

10% of the Novartis pipeline.

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FAP-2286 Acquired FAP-2286 (Ph1/2), a potential first-in-class

radioligand therapy with the respective radioligand

imaging agent, from Clovis Oncology

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Bicycle Peptides Novartis entered into research collaboration on bicyclic

peptides with Bicycle Therapeutics

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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.

(MORE TO FOLLOW) Dow Jones Newswires

April 25, 2023 01:00 ET (05:00 GMT)

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