On October 28, 2025 Novartis CEO Vas Narasimhan, reported on Q3 2025 results and said;
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"Novartis delivered solid financial performance in Q3, more than offsetting the impact of increasing generic erosion in the US. Our key growth drivers performed well, including Kisqali, Kesimpta, Pluvicto and Scemblix. Importantly, we achieved FDA approval for Rhapsido in CSU and positive Phase III readouts for ianalumab in Sjogren’s disease – two assets with pipeline-in-a-pill potential that could underpin our growth through 2030 and beyond. In addition, we completed several deals in the quarter to further strengthen our pipeline in core therapeutic areas. We remain well on track to achieve our guidance for 2025 and over the mid-term."
Key figures
Q3 2025 Q3 2024 % change 9M 2025 9M 2024 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 13 909 12 823 8 7 41 196 37 164 11 11
Operating income 4 501 3 627 24 27 14 028 11 014 27 31
Net income 3 930 3 185 23 25 11 563 9 119 27 29
EPS (USD) 2.04 1.58 29 31 5.94 4.50 32 35
Free cash flow 6 217 5 965 4 15 941 12 618 26
Core operating income 5 460 5 145 6 7 16 960 14 635 16 18
Core net income 4 330 4 133 5 6 13 522 11 822 14 17
Core EPS (USD) 2.25 2.06 9 10 6.94 5.83 19 21
Strategy
Our focus
Novartis is a "pure-play" innovative medicines company. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.
Our priorities
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
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.
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.
Financials
Third quarter
Net sales were USD 13.9 billion (+8%, +7% cc), with volume contributing 16 percentage points to growth. Generic competition had a negative impact of 7 percentage points, driven by Promacta, Tasigna and Entresto generics in the US. Pricing had a negative impact of 2 percentage points, driven by revenue deduction adjustments mainly in the US. Currency had a positive impact of 1 percentage point.
Operating income was USD 4.5 billion (+24%, +27% cc), mainly driven by higher net sales and lower impairments, partly offset by higher R&D investments.
Net income was USD 3.9 billion (+23%, +25% cc), mainly driven by higher operating income. EPS was USD 2.04 (+29%, +31% cc), benefiting from the lower weighted average number of shares outstanding.
Core operating income was USD 5.5 billion (+6%, +7% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.3% of net sales (-0.8 percentage points, stable in cc).
Core net income was USD 4.3 billion (+5%, +6% cc), mainly due to higher core operating income, partly offset by other core financial income and expense. Core EPS was USD 2.25 (+9%, +10% cc), benefiting from the lower weighted average number of shares outstanding.
Free cash flow amounted to USD 6.2 billion (+4% USD), compared with USD 6.0 billion in the prior-year quarter, driven by higher net cash flows from operating activities.
Nine months
Net sales were USD 41.2 billion (+11%, +11% cc), with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 3 percentage points, while pricing and currency had no impact.
Operating income was USD 14.0 billion (+27%, +31% cc), mainly driven by higher net sales and lower impairments, partly offset by higher investments behind priority brands and launches.
Net income was USD 11.6 billion (+27%, +29% cc), mainly driven by higher operating income. EPS was USD 5.94 (+32%, +35% cc), benefiting from the lower weighted average number of shares outstanding.
Core operating income was USD 17.0 billion (+16%, +18% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 41.2% of net sales, increasing 1.8 percentage points (2.5 percentage points cc).
Core net income was USD 13.5 billion (+14%, +17% cc), mainly due to higher core operating income. Core EPS was USD 6.94 (+19%, +21% cc), benefiting from the lower weighted average number of shares outstanding.
Free cash flow amounted to USD 15.9 billion (+26% USD), compared with USD 12.6 billion in the prior-year period, driven by higher net cash flows from operating activities.
Q3 priority brands
Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q3 growth) including:
Kisqali (USD 1 329 million, +68% cc) sales grew strongly across all regions, including +91% 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.
Kesimpta (USD 1 222 million, +44% cc) sales grew across all regions driven by increased demand and strong access.
Pluvicto (USD 564 million, +45% cc) showed sustained demand growth 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, with 25 countries now approved including Japan.
Scemblix (USD 358 million, +95% cc) sales grew across all regions, demonstrating the continued high unmet need in CML, with strong momentum from the early-line indication in the US and Japan.
Leqvio (USD 308 million, +54% cc) continued steady growth across all regions, with a focus on increasing account and patient adoption, and continuing medical education.
Fabhalta (USD 149 million, +236% cc) sales grew, reflecting market share gains in PNH globally and continued launch progress in IgAN and C3G in the US.
Lutathera (USD 213 million, +11% cc) sales grew mainly in the US, Japan and Europe due to increased demand and earlier-line adoption.
Cosentyx (USD 1 698 million, -1% cc) sales were broadly stable, as strong volume growth in the US was partially offset by higher revenue deductions, and ex-US declined due to a one-time price effect in the prior year. Novartis remains confident in Cosentyx USD 8 billion+ peak sales guidance.
Zolgensma (USD 301 million, -5% cc) sales declined reflecting a lower incidence of SMA compared to prior year.
Net sales of the top 20 brands in the third quarter and nine months
Q3 2025 % change 9M 2025 % change
USD m USD cc USD m USD cc
Entresto 1 877 1 -1 6 495 15 15
Cosentyx
– excl. revenue deduction adjust.* 1 698
0
5 -1
4 4 861
7
9 7
9
Kisqali 1 329 69 68 3 462 62 63
Kesimpta 1 222 46 44 3 198 41 40
Tafinlar + Mekinist 550 3 1 1 675 9 9
Jakavi 539 8 4 1 555 7 6
Promacta/Revolade 362 -36 -38 1 410 -14 -14
Pluvicto 564 46 45 1 389 33 33
Ilaris 473 27 26 1 369 25 24
Xolair 440 5 3 1 339 8 8
Tasigna 221 -47 -48 925 -27 -26
Zolgensma 301 -2 -5 925 -3 -4
SandostatinGroup 302 -1 -1 922 -5 -5
Scemblix 358 97 95 894 85 84
Leqvio 308 56 54 863 63 61
Lutathera 213 12 11 613 15 14
ExforgeGroup 176 1 0 546 0 2
Lucentis 148 -40 -42 510 -39 -39
DiovanGroup 143 -5 -5 447 -1 0
GalvusGroup 126 -21 -20 373 -19 -16
Top 20 brands total 11 350 10 9 33 771 14 14
*Sales growth impacted by a one-time revenue deduction adjustment in the US
R&D update – key developments from the third quarter
New approvals
Rhapsido
(remibrutinib) Rhapsido was approved by the FDA as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. It is the first FDA-approved Bruton’s tyrosine kinase inhibitor (BTKi) for CSU. Remibrutinib is also in Phase III development for chronic inducible urticaria, hidradenitis suppurativa and food allergy, as well as multiple sclerosis and myasthenia gravis.
Regulatory updates
Scemblix (asciminib) The CHMP of the EMA adopted a positive opinion and recommended granting marketing authorization for Scemblix for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment.
Results from ongoing trials and other highlights
Ianalumab
(VAY736) The Phase III NEPTUNUS-1 and -2 trials evaluating ianalumab in adults with active Sjögren’s disease met their primary endpoint, showing statistically significant improvements in disease activity as measured by a reduction in ESSDAI compared to placebo. Ianalumab was well tolerated and demonstrated a favorable safety profile, supporting its potential to become the first targeted treatment for this chronic autoimmune disease. Novartis plans to submit ianalumab to health authorities globally and was granted Fast Track Designation by the FDA.
In the Phase III VAYHIT2 trial, ianalumab plus eltrombopag significantly extended the time to treatment failure compared to placebo plus eltrombopag in adult patients with primary immune thrombocytopenia (ITP), previously treated with corticosteroids. The safety profile was consistent with previous studies. Data will be presented at an upcoming medical meeting and included in regulatory submissions in 2027.
Ianalumab is also in Phase III development for systemic lupus erythematosus, lupus nephritis and warm autoimmune hemolytic anemia.
Pluvicto
(lutetium Lu177
vipivotide
tetraxetan) In the Phase III PSMAddition trial, Pluvicto plus standard-of-care (SoC) reduced risk of progression or death by 28% versus SoC alone, with a positive trend in overall survival in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC). Safety remained consistent with PSMAfore and VISION trials. Data presented at ESMO (Free ESMO Whitepaper).
Kisqali
(ribociclib) The five-year analysis of the pivotal Phase III NATALEE trial in the broadest population of high-risk stage II and III HR+/HER2- early breast cancer (eBC) showed the addition of Kisqali to endocrine therapy (ET) reduced the risk of recurrence by 28.4% compared to ET alone. Data also showed a 29.1% risk reduction in distant disease-free survival, a positive trend in overall survival, and no new safety signals. Data presented at ESMO (Free ESMO Whitepaper).
Cosentyx
(secukinumab) The Phase III REPLENISH study met its primary endpoint, with Cosentyx demonstrating statistically significant and clinically meaningful sustained remission compared to placebo at week 52 in adults with relapsing polymyalgia rheumatica (PMR). Full data will be presented at an upcoming medical congress and submitted to health authorities in 2026.
Fabhalta
(iptacopan) In the Phase III APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful superiority compared to placebo in slowing IgAN progression measured by annualized total slope of estimated glomerular filtration rate (eGFR) decline over two years. Full data will be presented at future medical meetings and included in regulatory submissions in 2026.
Leqvio
(Inclisiran) In the Phase IV V-DIFFERENCE study, 85% of patients with hypercholesterolemia who had not reached guideline-recommended LDL-C targets despite optimized lipid-lowering therapy (LLT) achieved their goals with Leqvio plus LLT, versus 31% with placebo plus LLT, with benefits evident in as early as 30 days. Leqvio also reduced LDL-C by 59% over 360 days, outperforming placebo plus LLT by 35%. Data presented at ESC.
Entresto
(sacubitril/ valsartan) Data from the Phase IV PARACHUTE-HF study in patients with heart failure with reduced ejection fraction due to chronic Chagas disease showed that Entresto outperformed enalapril on a composite endpoint of cardiovascular death, heart failure hospitalization or NT-proBNP change. Entresto was well tolerated, with no new safety signals identified. Data presented at ESC.
Kesimpta
(ofatumumab) In the ARTIOS Phase IIIb study, patients with RMS who switched to Kesimpta after breakthrough disease on fingolimod or fumarate-based therapies showed a substantial reduction in disease activity. This was reflected in a low annualized relapse rate (ARR of 0.06 over 96 weeks), near-complete suppression of MRI activity, and over 90% of participants achieving no evidence of disease activity (NEDA-3). No new safety concerns were identified, regardless of prior disease-modifying treatment.
In the separate ALITHIOS open-label extension study, more than 90% of naïve patients receiving Kesimpta showed no evidence of disease activity (NEDA-3) at 7 years, with no new safety concerns, reinforcing the benefit of introducing Kesimpta early. Data from both studies presented at ECTRIMS.
Selected transactions Novartis entered into an agreement to acquire Tourmaline Bio, a clinical-stage biopharmaceutical company developing pacibekitug, a Phase III-ready anti-IL-6 monoclonal antibody for atherosclerotic cardiovascular disease (ASCVD). In Phase II, pacibekitug reduced median high-sensitivity C-reactive protein (hsCRP) levels by up to 86% compared to placebo, with similar incidence rates of adverse events and serious adverse events. The transaction is expected to close on October 28, 2025.
Novartis entered a second collaboration with Monte Rosa Therapeutics, in addition to the existing license agreement for VAV1 degraders, announced in October 2024. Under the new agreement, Novartis receives an exclusive license to an undisclosed discovery target and options to license two programs from Monte Rosa’s preclinical immunology portfolio.
Novartis continued its collaboration with Argo Biopharma, adding two new agreements: an exclusive license to an siRNA candidate currently in IND-enabling studies and expected to enter Phase I in 2026, and an option to exclusively license two second-generation siRNA molecules currently in development, with a right of first negotiation to the Phase II ANGPTL3 program.
Novartis entered into a global licensing and collaboration agreement with Arrowhead Pharmaceuticals for ARO-SNCA, a preclinical-stage siRNA therapy targeting alpha-synuclein for the treatment of synucleinopathies such as Parkinson’s disease. The agreement also includes additional collaboration targets leveraging Arrowhead’s proprietary Targeted RNAi Molecule (TRiM) platform.
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.
During the first nine months of 2025, Novartis repurchased a total of 66.4 million shares for USD 7.5 billion on the SIX Swiss Exchange second trading line. These repurchases included 49.1 million shares (USD 5.4 billion) under the USD 15 billion share buyback (announced in July 2023 and completed in July 2025) and 6.6 million shares (USD 0.8 billion) under the new up-to USD 10 billion share buyback announced in July 2025. In addition, 10.7 million shares (USD 1.3 billion) were repurchased to mitigate anticipated full-year dilution related to the equity-based compensation plans of associates. Further, 1.6 million shares (equity value of USD 0.2 billion) were repurchased from associates. In the same period, 11.7 million shares (equity value of USD 0.9 billion) were delivered to associates related to equity-based compensation plans. Consequently, the total number of shares outstanding decreased by 56.3 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 6.8 billion and a net cash outflow of USD 7.7 billion.
Net debt increased to USD 20.4 billion at September 30, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 15.9 billion being more than offset by the USD 7.8 billion annual dividend payment, cash outflows for treasury share transactions of USD 7.7 billion and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 3.7 billion.
As of Q3 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.
2025 outlook
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
Foreign exchange impact
If late-October exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be neutral to positive 1 percentage point on net sales and negative 2 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.
Key figures1
Q3 2025 Q3 2024 % change 9M 2025 9M 2024 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 13 909 12 823 8 7 41 196 37 164 11 11
Operating income 4 501 3 627 24 27 14 028 11 014 27 31
As a % of sales 32.4 28.3 34.1 29.6
Net income 3 930 3 185 23 25 11 563 9 119 27 29
EPS (USD) 2.04 1.58 29 31 5.94 4.50 32 35
Net cash flows from
operating activities 6 571 6 286 5 16 880 13 426 26
Non-IFRS measures
Free cash flow 6 217 5 965 4 15 941 12 618 26
Core operating income 5 460 5 145 6 7 16 960 14 635 16 18
As a % of sales 39.3 40.1 41.2 39.4
Core net income 4 330 4 133 5 6 13 522 11 822 14 17
Core EPS (USD) 2.25 2.06 9 10 6.94 5.83 19 21
(Press release, Novartis, OCT 28, 2025, View Source [SID1234657040])