Pelabresib

Ad hoc announcement pursuant to Art. 53 LR Full year Net sales grew +8% (cc 1 , +8% USD) with core operating income 1 up +14% (cc, +12% USD) Sales growth driven by continued strong performance from priority brands including Kisqali (+57% cc), Kesimpta (+36% cc), Pluvicto (+42% cc), Scemblix (+85% cc) and Cosentyx (+8% cc) Core operating income margin 1 was 40.1%, +210 basis points (cc) Operating income grew +25% (cc, +21% USD); net income up +19% (cc, +17% USD) Core EPS 1 grew +17% (cc, +15% USD) to USD 8.98 Free cash flow 1 of USD 17.6 billion (+8% USD) driven by higher net cash flows from operating activities Fourth quarter Net sales -1% (cc, +1% USD), impacted by US generic erosion and revenue deduction adjustments; core operating income +1% (cc, +1% USD) Priority brands continued their strong momentum including Kisqali (+44% cc), Kesimpta (+27% cc), Pluvicto (+70% cc), Scemblix (+87% cc) and Cosentyx (+11% cc) Q4 selected innovation milestones: Remibrutinib FDA submission for the most common subtype of CINDU Pelabresib positive Phase III MANIFEST-2 96-week data; filing planned in EU, US Phase III planned Itvisma FDA approval as the only gene replacement therapy for a broad SMA population Scemblix EC approval for newly diagnosed patients with Ph+ CML in chronic phase Pluvicto FDA submission for PSMA+ metastatic hormone-sensitive prostate cancer Dividend , guidance Dividend of CHF 3.70 per share, an increase of 5.7% , proposed for 2025 2026 guidance 2 – Net sales expected to grow low single-digit and core operating income expected to decline low single-digit Basel, February 4, 2026 – Commenting on Q4 2025 results, Vas Narasimhan, CEO of Novartis, said: “Novartis delivered strong performance in 2025, with high single-digit sales growth and core margin expansion despite significant US generic entries. Growth drivers Kisqali , Kesimpta , Pluvicto , Scemblix and Cosentyx continued their strong trajectory. We advanced several potential multi-blockbusters in our pipeline, with FDA approvals and positive Phase III readouts across Rhapsido , Pluvicto, Itvisma and ianalumab. We also strengthened our pipeline through strategic deals, including the proposed acquisition of Avidity, which we expect to close in the first half. In 2026, we expect to grow through the largest patent expiry in Novartis history, underscoring the strength of our business, and remain well on track to deliver our mid-term guidance.” Key figures Q4 2025 Q4 2024 % change FY 2025 FY 2024 % change USD m 3 USD m 3 USD cc USD m 3 USD m 3 USD cc Net sales 13 336 13 153 1 -1 54 532 50 317 8 8 Operating income 3 616 3 530 2 4 17 644 14 544 21 25 Net income 2 404 2 820 -15 -14 13 967 11 939 17 19 EPS (USD) 1.26 1.42 -11 -11 7.21 5.92 22 24 Free cash flow 1 655 3 635 -54 17 596 16 253 8 Core operating income 4 929 4 859 1 1 21 889 19 494 12 14 Core net income 3 889 3 933 -1 -2 17 411 15 755 11 12 Core EPS (USD) 2.03 1.98 3 2 8.98 7.81 15 17 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 44 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 6. 3. USD millions unless indicated otherwise. 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 Fourth quarter Net sales were USD 13.3 billion (+1%, -1% cc), with volume contributing 18 percentage points to growth. Generic competition had a negative impact of 15 percentage points, including a negative impact of 3 percentage points from revenue deduction adjustments in the US, mainly related to Entresto and Promacta . Pricing had a negative impact of 4 percentage points. Currency had a positive impact of 2 percentage points. Operating income was USD 3.6 billion (+2%, +4% cc), benefiting from higher government grant income and lower SG&A expenses, partly offset by higher R&D expenses. Net income was USD 2.4 billion (-15%, -14% cc), impacted by higher income taxes. EPS was USD 1.26 (-11%, -11% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 4.9 billion (+1%, +1% cc), benefiting from higher government grant income and lower SG&A expenses, partly offset by higher R&D expenses. Core operating income margin was 37.0% of net sales, increasing 0.1 percentage points (0.7 percentage points in cc). Core net income was USD 3.9 billion (-1%, -2% cc), mainly due to lower other financial income. Core EPS was USD 2.03 (+3%, +2% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 1.7 billion (-54%), driven by lower net cash flows from operating activities. Full year Net sales were USD 54.5 billion (+8%, +8% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 6 percentage points, pricing had a negative impact of 1 percentage point and currency had no impact. Operating income was USD 17.6 billion (+21%, +25% cc), mainly driven by higher net sales and lower impairments, partly offset by higher investments behind priority brands and launches. Net income was USD 14.0 billion (+17%, +19% cc), mainly driven by higher operating income. EPS was USD 7.21 (+22%, +24% cc), benefiting from the lower weighted average number of shares outstanding. Core operating income was USD 21.9 billion (+12%, +14% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 40.1% of net sales, increasing 1.4 percentage points (2.1 percentage points cc). Core net income was USD 17.4 billion (+11%, +12% cc), mainly due to higher core operating income. Core EPS was USD 8.98 (+15%, +17% cc), benefiting from the lower weighted average number of shares outstanding. Free cash flow amounted to USD 17.6 billion (+8%), driven by higher net cash flows from operating activities. Q4 priority brands Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q4 growth) including: Kisqali (USD 1 321 million, +44% cc) sales grew strongly across all regions, with strong momentum from the early breast cancer indication as well as continued share gains in metastatic breast cancer. Strong volume growth in the US was partially offset by revenue deduction adjustments; underlying growth globally was +54% cc. Kesimpta (USD 1 228 million, +27% cc) sales grew across all regions driven by increased demand and strong access. Pluvicto (USD 605 million, +70% cc) sales reflect continued strong demand in the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) setting in the US, as well as access expansion ex-US in the post-taxane mCRPC setting. Cosentyx (USD 1 807 million, +11% cc) sales grew across all regions, driven by volume, with continued demand for recent launches (including HS and IV in the US) and steady performance in core indications (PsO, PsA, AS and nr-AxSpA). Scemblix (USD 391 million, +87% 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 335 million, +46% cc) continued steady growth across all regions, with a focus on increasing account and patient adoption and continuing medical education. Fabhalta (USD 155 million, +167% cc) sales grew, reflecting continued launch execution in PNH as well as renal indications IgAN and C3G. Zolgensma Group (USD 307 million, +12% cc) sales grew, reflecting strong demand for the IV formulation in the incident SMA population. Lutathera (USD 203 million, +5% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier-line adoption. Net sales of the top 20 brands in the fourth quarter and full year Q4 2025 % change FY 2025 % change USD m USD cc USD m USD cc Entresto - excl. revenue deduction adjust.* 1 253 -43 -32 -45 -34 7 748 -1 -2 Cosentyx 1 807 13 11 6 668 9 8 Kisqali - excl. revenue deduction adjust.* 1 321 46 57 44 54 4 783 58 57 Kesimpta 1 228 29 27 4 426 37 36 Tafinlar + Mekinist 540 2 -2 2 215 8 6 Jakavi 555 14 8 2 110 9 7 Pluvicto 605 72 70 1 994 43 42 Ilaris 514 24 22 1 883 25 24 Xolair 384 -4 -8 1 723 5 4 Promacta/Revolade - excl. revenue deduction adjust.* 226 -61 -47 -63 -49 1 636 -26 -27 Scemblix 391 89 87 1 285 87 85 Zolgensma Group 307 17 12 1 232 1 0 Sandostatin Group 291 -5 -7 1 213 -5 -5 Leqvio 335 50 46 1 198 59 57 Tasigna 179 -56 -58 1 104 -34 -34 Lutathera 203 7 5 816 13 12 Exforge Group 181 14 11 727 3 4 Lucentis 133 -37 -40 643 -38 -40 Diovan Group 157 12 9 604 2 2 Fabhalta 155 172 167 505 291 287 Top 20 brands total 10 765 2 -1 44 513 12 11 *Q4 sales growth impacted by US revenue deduction adjustments in the current and prior year. No significant impact on full year. R&D update - key developments from the fourth quarter New approvals Itvisma (OAV101 IT) FDA approved Itvisma for the treatment of children two years and older, teens and adults living with spinal muscular atrophy (SMA) with a confirmed mutation in the survival motor neuron 1 ( SMN1 ) gene. It is the first and only gene replacement therapy available for this broad population. Scemblix (asciminib) EC approved an expanded indication for Scemblix , which is now approved for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in all lines of treatment. Regulatory updates Pluvicto (lutetium Lu177 vipivotide tetraxetan) FDA submission for Pluvicto in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) was completed based on Phase III PSMAddition data. Remibrutinib (LOU064) FDA submission for remibrutinib in the symptomatic dermographism subtype of chronic inducible urticaria (CIndU) was completed, based on relevant cohort data from the ongoing Phase III REMIND study. Full study readout and submission for the remaining two subtypes of CINDU expected in 2026. Results from ongoing trials and other highlights Ianalumab (VAY736) In the Phase III NEPTUNUS-1 and -2 trials, ianalumab demonstrated a clinically meaningful benefit in Sjögren’s disease, showing both improvement in disease activity and reductions in patient burden. Data presented at ACR. Novartis plans to submit to health authorities globally starting in early 2026. In January, ianalumab was awarded FDA breakthrough designation in Sjögren’s disease. In the Phase III VAYHIT2 trial, ianalumab plus eltrombopag significantly extended disease control by 45% in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids. The median time to treatment failure (TTF) was 2.8 times longer than placebo plus eltrombopag. Data presented at ASH, simultaneously published in NEJM, and will be included in regulatory submissions in 2027. Ianalumab is also in Phase III development for first-line ITP, warm autoimmune hemolytic anemia, systemic lupus erythematosus and lupus nephritis. Pelabresib 96-week results from the Phase III MANIFEST-2 trial with pelabresib plus ruxolitinib continued to show deep and durable spleen volume reduction and sustained improvements in total symptom score and anemia. Data represent the longest follow-up of JAK-inhibitor-naive myelofibrosis patients in a randomized combination trial and showed a comparable safety pro ruxolitinib alone, including numerically fewer deaths and disease progressions in pelabresib arm. Data presented at ASH. KLU156 (ganaplacide/ lumefantrine) In the Phase III KALUMA trial for malaria, KLU156 met its primary endpoint of non-inferiority to the standard of care (SoC), Coartem. The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94.0% with SoC. Data presented at the American Society of Tropical Medicine and Hygiene annual meeting 2025. If approved, KLU156 would represent the first major innovation in treatment of the deadliest form of malaria in 25 years. Kisqali (ribociclib) In a pooled, post-hoc exploratory analysis of first-line patients in the MONALEESA trials, one in four patients with HR+/HER2- advanced breast cancer (aBC) remained progression-free for four or more years following treatment with Kisqali plus endocrine therapy (ET). Data presented at SABCS. The five-year analysis of the Phase III NATALEE trial in HR+/HER2- early breast cancer (eBC) showed the addition of Kisqali to endocrine therapy 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 (DDFS), a positive trend in overall survival and no new safety signals. Data presented at ESMO. A further sub-analysis was presented at SABCS, showing that Kisqali plus a nonsteroidal aromatase inhibitor (NSAI) continued to result in improved DDFS compared to NSAI alone. The benefit was consistent across subgroups, reinforcing Kisqali plus NSAI as a treatment option for the broadest population of eBC patients. Pluvicto (lutetium Lu177 vipivotide tetraxetan) In the Phase III PSMAddition trial, Pluvicto plus SoC (ARPI + ADT) significantly reduced risk of radiographic progression or death by 28% versus SoC alone, with a positive trend in overall survival at interim analysis (follow-up ongoing), in patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC). Safety pro tolerability remained consistent with PSMAfore and VISION trials. Data presented at ESMO. 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 H1 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 eGFR decline over two years. Full data will be presented at future medical meetings and included in regulatory submissions in 2026. Selected transactions Novartis entered into an agreement to acquire Avidity Biosciences, a biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis, including potential multi-billion-dollar opportunities for DM1 and FSHD, and provide access to a differentiated RNA-targeting delivery platform. Transaction expected to close in H1 2026, subject to completion of the separation of SpinCo from Avidity and other customary closing conditions. 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 2025, Novartis repurchased a total of 77.6 million shares for USD 8.9 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 17.8 million shares (USD 2.3 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 the full-year dilution related to equity-based compensation plans of employees. Furthermore, 1.7 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 12.4 million shares (equity value of USD 1.2 billion) were delivered to employees related to equity-based compensation plans. Consequently, the total number of shares outstanding decreased by 66.9 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 8.0 billion and a net cash outflow of USD 9.2 billion. Net debt increased to USD 21.9 billion at December 31, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 17.6 billion being more than offset by the cash outflows for treasury share transactions of USD 9.2 billion, the USD 7.8 billion annual dividend payment, and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 5.2 billion. On December 31, 2025, Novartis reached the 2025 Patient Access Targets under its sustainability-linked bond issued in 2020 and therefore, no interest rate adjustment will be applied, and the bond will continue to pay 0.000% interest until its Maturity Date on September 23, 2028. As of Q4 2025, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings. 2026 outlook Barring unforeseen events; growth vs. prior year in cc Net sales Expected to grow low single-digit Core operating income Expected to decline low single-digit Foreign exchange impact If late-January exchange rates prevail for the remainder of 2026, the foreign exchange impact for the year would be positive 2 to positive 3 percentage points on net sales and positive 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website. Agreement with US government on lowering drug prices in the US On December 19, 2025, Novartis reached an agreement with the US government that aims to lower the price of innovative medicines in the US and support continued US investment in manufacturing, and research and development. The implications of that agreement are reflected in our 2026 guidance and in our 5-6% five-year sales CAGR guidance for 2025-2030. We will continue to monitor the longer-term implications as the agreement is implemented. Annual General Meeting Dividend proposal The Novartis Board of Directors proposes a dividend payment of CHF 3.70 per share for 2025, up 5.7% from CHF 3.50 per share in the prior year, representing the 29th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the Annual General Meeting on March 6, 2026. Reduction of share capital The Novartis Board of Directors proposes to cancel 77 602 358 shares (36 725 440 shares repurchased under the authorization of March 7, 2023, and 40 876 918 shares repurchased under the authorization of March 7, 2025) and to reduce the share capital accordingly by CHF 38 025 155.42, from CHF 1 035 086 714.83 to CHF 997 061 559.41. Elections of the Board Chair and members of the Board of Directors Mr. Daniel Hochstrasser will not stand for re-election to the Board of Directors. The Board and Executive Committee of Novartis thank him for his years of dedicated service as a member of the Board. The Board of Directors proposes the re-election of all other current members of the Board, including the Board Chair. In addition, the Board proposes the election of Dr. Charles Swanton, a distinguished physician-scientist in oncology, to the Board of Directors. Key figures 1 Q4 2025 Q4 2024 % change FY 2025 FY 2024 % change USD m 2 USD m 2 USD cc USD m 2 USD m 2 USD cc Net sales 13 336 13 153 1 -1 54 532 50 317 8 8 Operating income 3 616 3 530 2 4 17 644 14 544 21 25 As a % of sales 27.1 26.8 32.4 28.9 Net income 2 404 2 820 -15 -14 13 967 11 939 17 19 EPS (USD) 1.26 1.42 -11 -11 7.21 5.92 22 24 Net cash flows from operating activities 2 264 4 193 -46 19 144 17 619 9 Non-IFRS measures Free cash flow 1 655 3 635 -54 17 596 16 253 8 Core operating income 4 929 4 859 1 1 21 889 19 494 12 14 As a % of sales 37.0 36.9 40.1 38.7 Core net income 3 889 3 933 -1 -2 17 411 15 755 11 12 Core EPS (USD) 2.03 1.98 3 2 8.98 7.81 15 17 1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 44 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. USD millions unless indicated otherwise. Detailed financial results accompanying this press release are included in the Condensed Financial Report at the link below: Disclaimer This communication contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can generally be identified by words such as “plan,” “will,” “continue,” “ongoing,” “growth,” “launch,” “expect,” “deliver,” “accelerate,” “guidance,” “outlook,” “priority,” “potential,” “momentum,” “commitment,” or similar expressions, or by express or implied discussions regarding: potential new products; potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions, including the proposed acquisition of Avidity Biosciences, Inc. (“Avidity”) and Avidity’s related spin-off or sale of Atrium Therapeutics, Inc. 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AVIDITY’S STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF NOVARTIS AND AVIDITY WITH THE SEC IN CONNECTION WITH THE TRANSACTIONS OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTIONS AND THE PARTIES TO THE TRANSACTIONS. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Novartis and Avidity, once such documents are filed with the SEC, through the website maintained by the SEC at . Novartis and Avidity make available free of charge at the Novartis website at and Avidity’s website at investors.aviditybiosciences.com/sec-filings , respectively, copies of documents they or furnish to, the SEC. Participants in the Solicitation This communication does not constitute a solicitation of a proxy. 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Novartis will conduct a conference call with investors to discuss this news release today at 14:00 Central European time and 8:00 Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Novartis website. A replay will be available after the live webcast by visiting . Detailed financial results accompanying this press release are included in the Condensed Financial Report at the link below. Additional information is provided on our business and pipeline of selected compounds in late-stage development. A copy of today's earnings call presentation can be found at . Novartis issued its 2025 Annual Report today, and it is available at . Novartis will also 2025 Annual Report on Form 20-F with the US Securities and Exchange Commission today, and will post this document on . Novartis shareholders may receive a hard copy of either of these documents, each of which contains our complete audited financial statements, free of charge, upon request. Important dates March 6, 2026 Annual General Meeting April 28, 2026 First quarter 2026 results July 21, 2026 Second quarter & half year 2026 results October 27, 2026 Third quarter & nine months 2026 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 Please find full media release in English attached and on the following link: Media Release (PDF) Further language versions are available through the following links: German version is available through the following link: Medienmitteilung (PDF)