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Novartis Aktie 567514 / US66987V1098

04.02.2026 06:59:56

Press Release: Novartis delivered high -3-

KLU156 In the Phase III KALUMA trial for malaria, KLU156

(ganaplacide/ lumefantrine) 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.

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Kisqali In a pooled, post-hoc exploratory analysis of first-line

(ribociclib) 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.

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Pluvicto In the Phase III PSMAddition trial, Pluvicto plus

(lutetium Lu177 SoC (ARPI + ADT) significantly reduced risk of radiographic

vipivotide progression or death by 28% versus SoC alone, with

tetraxetan) a positive trend in overall survival at interim analysis

(follow-up ongoing), in patients with PSMA+ metastatic

hormone-sensitive prostate cancer (mHSPC). Safety

profile and tolerability remained consistent with

PSMAfore and VISION trials. Data presented at ESMO.

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Cosentyx The Phase III REPLENISH study met its primary endpoint,

(secukinumab) 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.

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Fabhalta In the Phase III APPLAUSE-IgAN final analysis, Fabhalta

(iptacopan) 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.

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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.

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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.

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

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Net sales Expected to grow low single-digit

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Core operating income Expected to decline low single-digit

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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.

(MORE TO FOLLOW) Dow Jones Newswires

February 04, 2026 01:00 ET (06:00 GMT)

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