![]() |
||
![]() |
Novartis International AG
CH-4002 Basel
Switzerland
https://www.novartis.com
http://x.com/NovartisNews
|
•
|
Q2 net sales grew +11% (cc1, +12% USD) with core operating income1 up +21% (cc, +20% USD)
|
o
|
Sales growth driven by continued strong performance from Kisqali (+64% cc), Entresto
(+22% cc), Kesimpta (+33% cc), Scemblix (+79% cc), Leqvio (+61% cc) and Pluvicto (+30% cc)
|
o
|
Core operating income margin1 reached 42.2%, +340 basis points (cc), mainly driven by higher net sales
|
•
|
Q2 operating income grew +25% (cc, +21% USD); net income up +26% (cc, +24% USD)
|
•
|
Q2 core EPS1 grew +24% (cc, +23% USD) to USD 2.42
|
•
|
Q2 free cash flow1 of USD 6.3 billion (+37%
USD) driven by higher net cash flows from operating activities
|
•
|
H1 net sales up +13% (cc, +12% USD) and core operating income up +24% (cc, +21% USD)
|
•
|
Q2 selected innovation milestones:
|
o
|
Pluvicto Phase III PSMAddition study positive readout in PSMA+
mHSPC
|
o
|
Vanrafia (atrasentan) FDA
accelerated approval for IgAN
|
o
|
OAV101 IT US and EU submissions for SMA
|
o
|
Votoplam Phase II PIVOT-HD study positive readout in
Huntington’s disease
|
o
|
Remibrutinib Phase II study positive readout in food allergy
|
•
|
Initiating up-to USD 10 billion share buyback to be completed by year-end 2027
|
•
|
Full-year 2025 guidance2 raised for core operating income
|
o
|
Sales expected to grow high single digit (unchanged)
|
o
|
Core operating income expected to grow low teens (from low double-digit)
|
Key figures
|
|||||||||
Q2 2025
|
Q2 2024
|
% change
|
H1 2025
|
H1 2024
|
% change
|
||||
|
USD m
|
USD m
|
USD
|
cc
|
|
USD m
|
USD m
|
USD
|
cc
|
Net sales
|
14 054
|
12 512
|
12
|
11
|
|
27 287
|
24 341
|
12
|
13
|
Operating income
|
4 864
|
4 014
|
21
|
25
|
|
9 527
|
7 387
|
29
|
33
|
Net income
|
4 024
|
3 246
|
24
|
26
|
|
7 633
|
5 934
|
29
|
31
|
EPS (USD)
|
2.07
|
1.60
|
29
|
32
|
|
3.91
|
2.91
|
34
|
37
|
Free cash flow
|
6 333
|
4 615
|
37
|
|
9 724
|
6 653
|
46
|
|
|
Core operating income
|
5 925
|
4 953
|
20
|
21
|
|
11 500
|
9 490
|
21
|
24
|
Core net income
|
4 710
|
4 008
|
18
|
19
|
|
9 192
|
7 689
|
20
|
22
|
Core EPS (USD)
|
2.42
|
1.97
|
23
|
24
|
|
4.69
|
3.77
|
24
|
27
|
1.
|
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a
rich pipeline across our core therapeutic areas.
|
2.
|
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains
disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
|
3.
|
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to
build trust with society.
|
|
2
|
|
Kisqali
|
(USD 1 177 million, +64% cc) sales grew strongly across all regions, including +100% growth in the US with strong momentum from the recently launched early breast cancer indication
as well as continued share gains in metastatic breast cancer
|
Entresto
|
(USD 2 357 million, +22% cc) sustained robust, demand-led growth globally
|
Kesimpta
|
(USD 1 077 million, +33% cc) sales grew across all regions driven by increased demand and strong access
|
Scemblix
|
(USD 298 million, +79% cc) sales grew across all regions, demonstrating the continued high unmet need in CML and continued strong momentum from the recently launched early-line
indication in the US
|
Leqvio
|
(USD 298 million, +61% cc) continued steady growth, with a focus on increasing account and patient adoption, and continuing medical education
|
Pluvicto
|
(USD 454 million, +30% cc) showed encouraging demand uptake in the US following the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) approval, as well as continued
access expansion ex-US in the post-taxane mCRPC setting
|
Cosentyx
|
(USD 1 629 million, +6% cc) sales grew mainly in the US and Europe, driven by recent launches as well as volume growth in core indications
|
Fabhalta
|
(USD 120 million) sales grew driven by continued launch execution across all markets in PNH as well as recent launches in IgAN and C3G in the US
|
Lutathera
|
(USD 207 million, +17% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier-line adoption, particularly in the US and Japan
|
Zolgensma
|
(USD 297 million, -17% cc) sales declined reflecting a lower incidence of SMA compared to prior year, while demand remained robust
|
|
3
|
|
Q2 2025
|
% change
|
H1 2025
|
% change
|
|||
USD m
|
USD
|
cc
|
USD m
|
USD
|
cc
|
|
Entresto
|
2 357
|
24
|
22
|
4 618
|
22
|
22
|
Cosentyx
|
1 629
|
7
|
6
|
3 163
|
11
|
11
|
Kisqali
|
1 177
|
64
|
64
|
2 133
|
59
|
60
|
Kesimpta
|
1 077
|
35
|
33
|
1 976
|
38
|
38
|
Tafinlar + Mekinist
|
573
|
10
|
7
|
1 125
|
13
|
13
|
Promacta/Revolade
|
502
|
-8
|
-9
|
1 048
|
-2
|
-1
|
Jakavi
|
524
|
11
|
8
|
1 016
|
7
|
8
|
Xolair
|
443
|
4
|
2
|
899
|
9
|
10
|
Ilaris
|
477
|
30
|
27
|
896
|
24
|
24
|
Pluvicto
|
454
|
32
|
30
|
825
|
26
|
26
|
Tasigna
|
327
|
-27
|
-27
|
704
|
-16
|
-15
|
Zolgensma
|
297
|
-15
|
-17
|
624
|
-3
|
-3
|
Sandostatin Group
|
303
|
-3
|
-3
|
620
|
-7
|
-6
|
Leqvio
|
298
|
64
|
61
|
555
|
67
|
66
|
Scemblix
|
298
|
82
|
79
|
536
|
79
|
78
|
Lutathera
|
207
|
18
|
17
|
400
|
16
|
16
|
Exforge Group
|
191
|
7
|
7
|
370
|
0
|
3
|
Lucentis
|
173
|
-37
|
-39
|
362
|
-39
|
-38
|
Diovan Group
|
154
|
-4
|
-4
|
304
|
1
|
3
|
Galvus Group
|
123
|
-18
|
-17
|
247
|
-17
|
-14
|
Top 20 brands total
|
11 584
|
16
|
14
|
22 421
|
16
|
17
|
Vanrafia
(atrasentan)
|
FDA granted accelerated approval for Vanrafia for the reduction of proteinuria in adults with primary IgA nephropathy
(IgAN) at risk of rapid disease progression. Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy.
|
Coartem
(artemether and lumefantrine)
|
In July, Swissmedic approved Coartem Baby, the first clinically proven malaria treatment specifically designed for newborns
and infants between 2-5 kg. This milestone paves the way for registration in eight African countries through the Marketing Authorization for Global Health Products (MAGHP) procedure.
|
OAV101 IT (onasemnogene abeparvovec)
|
Regulatory submissions for OAV101 IT in patients with spinal muscular atrophy (SMA) were completed in the US and EU.
|
|
4
|
|
Pluvicto
(lutetium Lu177 vipivotide tetraxetan)
|
At a prespecified interim analysis, the Phase III PSMAddition trial in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint with a
statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) in patients treated with Pluvicto plus standard of care (SoC) versus SoC
alone. The study also showed a positive trend in overall survival in favor of the Pluvicto arm. Data will be presented at an upcoming medical meeting and, based on FDA feedback,
submitted for regulatory review in H2 2025.
|
Cosentyx
(secukinumab)
|
In the Phase III GCAptAIN study, Cosentyx did not demonstrate a statistically significant improvement in sustained
remission compared to placebo in adults with newly diagnosed or relapsing giant cell arteritis (GCA). Safety in GCA was consistent with the known safety profile of Cosentyx.
|
Kisqali
(ribociclib)
|
A new subgroup analysis of the Phase III NATALEE trial in HR+/HER2- early breast cancer (eBC) showed that patients receiving Kisqali
plus endocrine therapy continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status, at median follow-up of 44.2 months. Data presented at ASCO.
|
Fabhalta
(iptacopan)
|
In the Phase IIIb APPULSE-PNH study, adult PNH patients with hemoglobin (Hb) levels ≥10g/dL who switched to Fabhalta from
anti-C5 therapies experienced clinically meaningful improvements in Hb levels. The vast majority (92.7%) achieved Hb ≥12g/dL, reaching normal or near-normal levels. No patients treated with Fabhalta
required transfusions, experienced breakthrough hemolysis or had any major adverse vascular events during the treatment period. Data presented at EHA.
|
Scemblix (asciminib)
|
In the Phase IIIb ASC4START trial evaluating the tolerability and efficacy of Scemblix versus nilotinib in adult patients
with newly diagnosed Ph+ CML-CP, patients treated with Scemblix had a 55% lower risk of discontinuation due to AEs vs nilotinib, and 12.7% more patients treated with Scemblix achieved major molecular responses by week 12 vs those treated with nilotinib. Data presented at ASCO and EHA.
|
Votoplam
|
The Phase II PIVOT-HD study of votoplam in patients with Stage 2 and Stage 3 Huntington's disease met its primary endpoint of reduction in blood Huntingtin (HTT)
protein levels at Week 12 (p<0.0001), with durable, dose-dependent lowering observed through Month 12. Across all dose levels and disease stages, votoplam showed a favorable safety and tolerability profile, with no
treatment-related serious adverse events or neurofilament light chain protein (NfL) spikes. Together with our partner, PTC Therapeutics, we are evaluating the results and plan to engage with the HD community and regulatory
authorities to inform next steps.
|
Remibrutinib
|
A Phase II study with remibrutinib in food allergy met its primary endpoint with a statistically significant and clinically meaningful benefit. These data support
remibrutinib's potential as a first-in-class oral BTK inhibitor that reduces the risk of severe allergic reactions, including anaphylaxis. Phase III study planning is underway.
|
Ianalumab
|
Novartis will not advance investigation of ianalumab in hidradenitis suppurativa following a Phase II proof-of-concept study which did not meet our target criteria
despite demonstrating efficacy vs placebo. No new safety signals were observed and all other studies for ianalumab in B-cell driven diseases continue as planned.
|
Rapcabtagene autoleucel (YTB323)
|
A Phase I/II study of rapcabtagene autoleucel, a rapidly manufactured CD19 CAR-T therapy using the T-Charge platform, demonstrated the expansion of CAR-T cells, deep
B cell depletion, early and sustained improvement in overall disease activity, and a favorable benefit/risk profile in 21 patients with severe refractory SLE up to 12 months after treatment. Data presented at EULAR.
|
|
5
|
|
Zigakibart
|
Updated results from the Phase I/II study for zigakibart in IgAN showed a robust and clinically meaningful reduction in proteinuria of 60.4% from baseline and eGFR
stabilization over 100 weeks of treatment. To date, this is the longest duration of treatment reported for an anti-APRIL agent, demonstrating long-term safety and efficacy. Data presented at ERA. The Phase III BEYOND trial is
ongoing with anticipated readout in 2026.
|
Selected transactions
|
Novartis has completed the acquisition of Regulus Therapeutics, a clinical-stage biopharmaceutical company focused on developing microRNA therapeutics. Regulus’
lead asset, farabursen, is a potential first-in-class oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD) that recently completed Phase Ib. The acquisition is aligned with
the therapeutic area focus of Novartis and leverages its strength and expertise in renal disease.
In July, Novartis entered into an agreement with Sironax, granting Novartis an exclusive option to acquire its Brain Delivery Module (BDM) platform, a
differentiated blood-brain-barrier crossing technology designed to enhance the brain delivery of therapeutics of various modalities.
|
|
6
|
|
Barring unforeseen events; growth vs. prior year in cc
|
|
Net sales
|
Expected to grow high single-digit
|
Core operating income
|
Expected to grow low-teens
|
•
|
We continue to assume Entresto US generic entry in mid-2025
for forecasting purposes, though timing of generic entry is subject to ongoing IP and regulatory litigation
|
|
7
|
|
Q2 2025
|
Q2 2024
|
% change
|
H1 2025
|
H1 2024
|
% change
|
||||
|
USD m
|
USD m
|
USD
|
cc
|
USD m
|
USD m
|
USD
|
cc
|
|
Net sales
|
14 054
|
12 512
|
12
|
11
|
27 287
|
24 341
|
12
|
13
|
|
Operating income
|
4 864
|
4 014
|
21
|
25
|
9 527
|
7 387
|
29
|
33
|
|
As a % of sales
|
34.6
|
32.1
|
|
|
34.9
|
30.3
|
|
|
|
Net income
|
4 024
|
3 246
|
24
|
26
|
7 633
|
5 934
|
29
|
31
|
|
EPS (USD)
|
2.07
|
1.60
|
29
|
32
|
3.91
|
2.91
|
34
|
37
|
|
Net cash flows from operating activities
|
6 664
|
4 875
|
37
|
|
10 309
|
7 140
|
44
|
|
|
Non-IFRS measures
|
|
|
|
|
|
|
|
|
|
Free cash flow
|
6 333
|
4 615
|
37
|
|
9 724
|
6 653
|
46
|
|
|
Core operating income
|
5 925
|
4 953
|
20
|
21
|
11 500
|
9 490
|
21
|
24
|
|
As a % of sales
|
42.2
|
39.6
|
|
|
42.1
|
39.0
|
|
|
|
Core net income
|
4 710
|
4 008
|
18
|
19
|
9 192
|
7 689
|
20
|
22
|
|
Core EPS (USD)
|
2.42
|
1.97
|
23
|
24
|
4.69
|
3.77
|
24
|
27
|
|
8
|
|
Important dates
|
|
October 28, 2025 |
Third quarter & nine months 2025 results
|
November 19-20, 2025 |
Meet Novartis Management 2025 (London, UK)
|
December 1, 2025
|
Social Impact & Sustainability annual investor
event (virtual)
|
February 4, 2026
|
Fourth quarter & full year 2025 results
|
Novartis Media Relations
E-mail: media.relations@novartis.com
|
|||
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com
|
|
9
|
|