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29.10.2024 06:59:56

Press Release: Novartis continues strong momentum -2-

As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the first nine months of 2024 related to discontinued operations. In the first nine months of 2023, discontinued operations net sales were USD 7.4 billion, operating income amounted to USD 265 million and net income from discontinued operations was USD 440 million. For further details see Note 3 "Significant acquisition of businesses and spin-off of Sandoz business" and Note 11 "Discontinued operations" to the condensed interim consolidated financial statements.

Total Company

Third quarter

Total Company net income was USD 3.2 billion in 2024, compared to USD 1.8 billion in 2023 and basic EPS was USD 1.58 compared to USD 0.85 in prior year quarter. Net cash flows from operating activities for total Company amounted to USD 6.3 billion and free cash flow amounted to USD 6.0 billion.

Nine months

Total Company net income was USD 9.1 billion in 2024, compared to USD 6.4 billion in 2023 and basic EPS was USD 4.50 compared to USD 3.05 in prior year. Net cash flows from operating activities for total Company amounted to USD 13.4 billion and free cash flow amounted to USD 12.6 billion.

Q3 key growth drivers

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including:

Entresto (USD 1 865 million, +26% cc) sustained robust, demand-led

growth, with increased penetration in the US and Europe

following guideline-directed medical therapy in heart

failure, as well as in China with increased penetration

in hypertension

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

Cosentyx (USD 1 693 million, +28% cc) sales grew mainly in

the US, Europe and emerging growth markets, driven

by recent launches (including the HS indication and

the IV formulation in the US) and volume growth in

core indications

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

Kisqali (USD 787 million, +43% cc) sales grew strongly across

all regions, based on increasing recognition of its

overall survival benefit in HR+/HER2- advanced breast

cancer and Category 1 NCCN guidelines recommendation

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

Kesimpta (USD 838 million, +28% cc) sales grew reflecting increased

demand for a high efficacy product with convenient

self-administered dosing; the prior-year period benefited

from a one-time revenue deduction adjustment in Europe

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

Pluvicto (USD 386 million, +50% cc) sales grew in the US and

Europe. Q3 sales benefited from a one-time revenue

deduction adjustment in Europe. With supply now unconstrained,

the focus is on increasing share in established RLT

sites, while opening new sites and referral pathways,

and initiating new patients

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

Leqvio (USD 198 million, +119% cc) continued to show steady

growth, with a focus on increasing account and patient

adoption, and continuing medical education

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

Jakavi (USD 500 million, +18% cc) sales grew across all regions

driven by strong demand across indications

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

Scemblix (USD 182 million, +72% cc) sales grew across all regions

demonstrating the continued high unmet need in CML

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

Tafinlar + (USD 534 million, +12% cc) sales grew mainly in the

Mekinist US and emerging growth markets, driven by increased

demand

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

Xolair (USD 418 million, +15% cc) grew mainly in emerging

growth markets and Europe

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

Fabhalta (USD 44 million) launch continues in PNH with an approval

in IgAN in Q3

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

Ilaris (USD 372 million, +12% cc) sales grew across all regions,

led by the US and Europe

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

Lutathera (USD 190 million, +19% cc) sales grew across all regions

due to increased demand and earlier line adoption

(within indication) in the US and Japan

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

Emerging Grew +12% (cc) overall. China grew +18% (cc) to USD

Growth 1.0 billion, mainly driven by Entresto, Cosentyx and

Markets* Leqvio

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

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

Net sales of the top 20 brands in the third quarter and nine months

Q3

2024 % change 9M 2024 % change

USD m USD cc USD m USD cc

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

Entresto 1 865 26 26 5 642 28 30

Cosentyx 1 693 27 28 4 545 24 25

Kesimpta 28 28 49 49

- excl. PY revenue deduction adjust. 838 55 56 2 274 61 62

Kisqali 787 40 43 2 131 45 48

Promacta/Revolade 569 -1 0 1 633 -4 -3

Tafinlar + Mekinist 534 11 12 1 531 7 9

Jakavi 500 17 18 1 449 14 16

Tasigna 419 -10 -9 1 260 -10 -9

Xolair 418 13 15 1 244 15 17

Ilaris 372 11 12 1 096 12 16

Pluvicto 51 50 47 47

- excl. revenue deduction adjust. 386 37 36 1 041 42 42

Sandostatin Group 305 -10 -8 973 -3 -1

Zolgensma 308 0 1 952 3 4

Lucentis 245 -33 -32 834 -29 -28

Exforge Group 174 -7 -4 544 -2 1

Lutathera 190 19 19 534 17 17

Leqvio 198 120 119 531 129 130

Scemblix 182 72 72 482 67 69

Galvus Group 159 -12 -6 458 -15 -8

Diovan Group 150 -2 2 450 -3 1

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

Top 20 brands total 10 292 17 18 29 604 17 19

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

R&D update - key developments from the third quarter

New approvals

Kisqali FDA approved Kisqali with a broad indication for HR+/HER2-

(ribociclib) stage II and III early breast cancer (eBC) at high

risk of recurrence, approximately doubling the population

eligible for CDK4/6 inhibitor adjuvant therapy, with

the inclusion of those without nodal involvement.

In addition, the CHMP issued a positive opinion for

Kisqali in eBC in October.

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

Fabhalta FDA granted accelerated approval to Fabhalta for the

(iptacopan) reduction of proteinuria in adults with primary immunoglobulin

A nephropathy (IgAN) at risk of rapid disease progression.

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

Regulatory updates

Pluvicto Completed FDA submission for Pluvicto pre-taxane mCRPC

(lutetium Lu177 vipivotide tetraxetan) label expansion based on the positive Phase III PSMAfore

study.

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

Scemblix FDA granted Priority Review status to Scemblix for

(asciminib) the treatment of newly diagnosed adult patients with

Philadelphia chromosome-positive CML in chronic phase

(Ph+ CML-CP). Scemblix is also under regulatory review

in this indication in key international markets worldwide,

including in China and Japan.

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

Fabhalta Submissions for the treatment of C3 glomerulopathy

(iptacopan) (C3G) completed in the EU, China and Japan.

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

(MORE TO FOLLOW) Dow Jones Newswires

October 29, 2024 02:00 ET (06:00 GMT)

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