On February 4, 2026 Novartis reported high single-digit sales growth, achieved 40% core margin and further advanced the pipeline in 2025.

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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 m3 USD m3 USD cc USD m3 USD m3 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.
ZolgensmaGroup (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
ZolgensmaGroup 307 17 12 1 232 1 0
SandostatinGroup 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
ExforgeGroup 181 14 11 727 3 4
Lucentis 133 -37 -40 643 -38 -40
DiovanGroup 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 approvedItvismafor 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 forScemblix, 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 forPluvictoin 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 (Free ASH Whitepaper), 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 profile versus ruxolitinib alone, including numerically fewer deaths and disease progressions in pelabresib arm. Data presented at ASH (Free ASH Whitepaper).
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 (Free ESMO Whitepaper). 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 profile and tolerability remained consistent with PSMAfore and VISION trials. 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 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 figures1

Q4 2025 Q4 2024 % change FY 2025 FY 2024 % change

USD m2 USD m2 USD cc
USD m2 USD m2 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.

(Press release, Novartis, FEB 4, 2026, View Source [SID1234662472])

On February 4, 2026 Novartis reported high single-digit sales growth, achieved 40% core margin and further advanced the pipeline in 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 m3 USD m3 USD cc USD m3 USD m3 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.
ZolgensmaGroup (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
ZolgensmaGroup 307 17 12 1 232 1 0
SandostatinGroup 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
ExforgeGroup 181 14 11 727 3 4
Lucentis 133 -37 -40 643 -38 -40
DiovanGroup 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 approvedItvismafor 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 forScemblix, 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 forPluvictoin 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 (Free ASH Whitepaper), 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 profile versus ruxolitinib alone, including numerically fewer deaths and disease progressions in pelabresib arm. Data presented at ASH (Free ASH Whitepaper).
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 (Free ESMO Whitepaper). 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 profile and tolerability remained consistent with PSMAfore and VISION trials. 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 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 figures1

Q4 2025 Q4 2024 % change FY 2025 FY 2024 % change

USD m2 USD m2 USD cc
USD m2 USD m2 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.

(Press release, Novartis, FEB 4, 2026, View Source [SID1234662472])

On February 4, 2026 Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of rare diseases with unmet medical needs, reported the closing of an exclusive license with Otsuka Pharmaceutical Co., Ltd (Otsuka) for OPB-171775. a novel molecular glue intended to be developed for the treatment of gastrointestinal stromal tumours (GIST). The compound also has the potential to be useful in additional indications. In Biodexa’s pipeline, OPB-171775 is to be coded MTX240.

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Stephen Stamp, Chief Executive Officer of Biodexa commented "MTX240 represents a fantastic opportunity for Biodexa. Its unique molecular glue mechanism of action separates MTX240 from current standard of care with the potential to benefit a broad spectrum of GIST patients, including those with TKI-resistant disease. MTX240 strategically aligns with our emerging GI/oncology pipeline which includes our ongoing Phase 3 development of eRapa in Familial Adenomatous Polyposis."

About MTX240, its Unique Mechanism of Action and Clinical Rationale

Molecular glue technology represents a novel approach that induces targeted protein interactions, offering a distinct mechanism of action to conventional kinase inhibitors for rare oncology indications.

GIST is driven by activating mutations in the KIT receptor tyrosine kinase. While tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib are reported to have significantly improved outcomes for GIST patients, resistance almost always develops through secondary KIT mutations or activation of alternative signalling pathways. This represents a substantial clinical challenge with limited therapeutic options for patients once they have cycled through the available TKIs.

MTX240 acts as a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT signalling. By triggering cell death through this alternative pathway, MTX240 is designed to overcome the resistance mechanisms that render TKI-resistant GISTs refractory to conventional kinase inhibitors. This novel mechanism may provide clinical benefit for a significant proportion of GIST patients, not only those who have developed resistance to TKIs.

MTX240, referenced as OPB-171775 in the charts, and vehicle were administered once daily for 21 days. Imatinib was administered twice daily for 21 days. The values represent mean tumor volumes +/- standard error of the mean GS5107 (n=3), GS5108 (n=5), GS11353 (n=5).

PDX models use actual tumor tissue harvested from patients, preserving the genetic complexity and treatment resistance patterns of real human cancers. This makes PDX studies far more predictive of human clinical outcomes because they bridge the gap between laboratory discovery and clinical trials5.

Addressing Unmet Medical Need in GIST

GIST is a rare gastrointestinal malignancy affecting approximately 3,000-4,000 patients annually in the United States2, with a significant unmet medical need for patients who develop TKI resistance. Approximately 10-15%3. of GIST patients are either primarily refractory, or develop secondary resistance, to available TKIs, and options for these patients remain limited. MTX240’s novel mechanism represents a potentially differentiated therapeutic approach that circumvents conventional resistance pathways and aligns with Biodexa’s strategic focus on rare disease development and addressing important clinical gaps.

The global GIST market is valued at approximately USD 1.3 billion and is expected to grow at 6-10% annually through 2032, driven by rising incidence and emerging therapeutic options targeting treatment-resistant disease4.

GIST qualifies for orphan drug designation in major regulatory jurisdictions, offering potential regulatory advantages and incentives to support drug development.

Licensing and Collaboration Agreement

Under the terms of the license agreement Biodexa has the exclusive rights to develop and commercialize MTX240 globally with the exception of Japan where Otsuka retains its rights. The agreement includes an upfront fee and additional development and regulatory milestones. In addition, tiered royalties in the mid-single digit range are payable on net sales of MTX240.

MTX240 benefits from composition of matter patents in the US, Europe, Japan and various other countries extending through 2037 without any patent term extension.

(Press release, Biodexa Pharmaceuticals, FEB 4, 2026, View Source [SID1234662471])

On February 4, 2026 GSK reported strong 2025 performance and re-affirms long-term outlooks.

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Sales, profit and earnings growth driven by strong Specialty Medicines performance
Total 2025 sales £32.7 billion +4% AER; +7% CER
Specialty Medicines sales £13.5 billion (+17%); Respiratory, Immunology & Inflammation £3.8 billion (+18%); Oncology
£2.0 billion (+43%); HIV sales £7.7 billion (+11%)
Vaccines sales £9.2 billion (+2%); Shingrix £3.6 billion (+8%); Meningitis vaccines £1.6 billion (+12%); and Arexvy £0.6
billion (+2%)
General Medicines sales £10.0 billion (-1%); Trelegy £3.0 billion (+13%)
Total operating profit >100% and Total EPS >100% driven by lower Significant legal expenses, lower CCL charges and
higher other operating income, partly offset by intangible asset impairments
Core operating profit +11% and Core EPS +12% reflecting Specialty Medicines and Vaccines growth, SG&A productivity,
higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines
Cash generated from operations of £8.9 billion with free cash flow of £4.0 billion
2025 Q4 2025
£m % AER % CER £m % AER % CER
Turnover 32,667 4 7 8,618 6 8
Total operating profit 7,932 97 >100 1,100 58 65
Total operating margin % 24.3% 11.5ppts 11.9ppts 12.8% 4.2ppts 4.6ppts
Total EPS 141.1p >100 >100 15.8p 56 65
Core operating profit 9,783 7 11 1,634 14 18
Core operating margin % 29.9% 0.7ppts 1.1ppts 19.0% 1.4ppts 1.6ppts
Core EPS 172.0p 8 12 25.5p 10 14
Cash generated from operations 8,943 14 2,689 4

R&D momentum further strengthens growth prospects:
Strong pipeline progress in 2025:
5 major FDA approvals: Blenrep, Exdensur, Nucala COPD, Penmenvy, Blujepa
7 pivotal trial starts including: risvutatug rezetecan (ris-rez) for 2L/3L ES-SCLC; efimosfermin in MASH; Exdensur for COPD; and velzatinib for 2L GIST
RI&I and Oncology pipelines strengthened:
New assets acquired: efimosfermin (liver disease); velzatinib/IDRX-42 (gastrointestinal cancer); and agreement to acquire ozureprubart (food allergies)
Agreements/collaborations with Hengrui (RI&I and oncology); Empirico (COPD); and LTZ Therapeutics (oncology)
29 projects currently in clinical development for RI&I and Oncology diseases
Further pipeline acceleration expected in 2026:
2 new major product approvals expected: bepirovirsen, potential first-in-class treatment for chronic hepatitis B; and tebipenem, first oral treatment for complicated UTIs
5 pivotal readouts: bepirovirsen for chronic hepatitis B (positive); camlipixant (chronic cough); Jemperli (rectal cancer); Q4M HIV PrEP; and Exdensur for EGPA
10 pivotal trial starts, including for ADCs B7-H3 (ris-rez) & B7-H4 (mocertatug rezetecan, mo-rez) to treat multiple cancer types

Continued commitment to shareholder returns
Q4 2025 dividend of 18p declared; 66p FY 2025; 70p expected for full year 2026
£1.4 billion executed to date as part of the £2 billion share buyback programme announced at FY 2024
2026 guidance and 2031 sales outlook reaffirmed
Expect 2026 turnover growth of between 3% to 5%; Core operating profit growth of between 7% to 9%; Core EPS growth of between 7% to 9%
2031 sales outlook of more than £40 billion

Luke Miels, Chief Executive Officer, GSK:
"GSK delivered another strong performance in 2025, driven mainly by Specialty Medicines, with double-digit sales growth in
Respiratory, Immunology & Inflammation (RI&I), Oncology and HIV. Good R&D progress also continued, with 5 major product
approvals achieved and several acquisitions and new partnerships completed to strengthen the pipeline further in oncology and RI&I. We expect this positive momentum to continue in 2026, which will be a key year of execution and operational delivery with strong focus on commercial launches and accelerating R&D. We are well placed to move forward in this next phase for GSK – to deliver our outlooks – and to create new value for patients and shareholders."

Assumptions and cautionary statement regarding forward-looking statements
The Group’s management believes that the assumptions outlined above are reasonable, and that the guidance,
outlooks, and expectations described in this report are achievable based on those assumptions. However, given the
forward-looking nature of these guidance, outlooks, and expectations, they are subject to greater uncertainty, including
potential material impacts if the above assumptions are not realised, and other material impacts related to foreign
exchange fluctuations, macro-economic activity, the impact of outbreaks, epidemics or pandemics, changes in
legislation, regulation, government actions and policies, including the impact of any potential tariffs or other restrictive
trade policies on the Group’s products, or intellectual property protection, product development and approvals, actions
by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, "forward-looking statements". Forward-looking
statements give the Group’s current expectations or forecasts of future events. An investor can identify these
statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’,
‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’, ‘outlook’, ‘aim’, ‘ambition’, ‘could’, ‘goal’, ‘may’,
‘seek’, ‘should’ and other words and terms of similar meaning in connection with any discussion of future operating or
financial performance. In particular, these include statements relating to future actions, prospective products or
product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the
outcome of contingencies such as legal proceedings, dividend payments and financial results. Other than in
accordance with its legal or regulatory obligations (including under the Market Abuse Regulation, the UK Listing Rules
and the Disclosure Guidance and Transparency Rules of the Financial Conduct Authority), the Group undertakes no
obligation to update any forward-looking statements, whether as a result of new information, future events or
otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents
which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures.
Accordingly, no assurance can be given that any particular expectation will be met and readers are cautioned not to
place undue reliance on the forward-looking statements.

All guidance, outlooks and expectations should be read together with the guidance and outlooks, assumptions and
cautionary statements in this full year and Q4 2025 earnings release and in the Group’s 2024 Annual Report on Form
20-F.

Forward-looking statements are subject to assumptions, inherent risks and uncertainties, many of which relate to
factors that are beyond the Group’s control or precise estimate. The Group cautions investors that a number of
important factors, including those in this document, could cause actual results to differ materially from those expressed
or implied in any forward-looking statement. Such factors include, but are not limited to, those discussed under ‘Risk
Factors’ in the Group’s Annual Report on Form 20-F for 2024. Any forward-looking statements made by or on behalf of
the Group speak only as of the date they are made and are based upon the knowledge and information available to
the Directors on the date of this report.

(Press release, GlaxoSmithKline, FEB 4, 2026, View Source [SID1234662470])

On February 4, 2026 Evogene Ltd. (Nasdaq/TASE: EVGN) ("Evogene"), a pioneering computational chemistry company specializing in generative design of small molecules for the pharmaceutical and agricultural industries, and Shanghai Lishan Biopharmaceuticals Co., Ltd. ("Lishan Biotech"), a China-based clinical-stage biotechnology company focused on innovative therapies in the fields of immunity and inflammation, reported that Biomica Ltd. ("Biomica"), Evogene’s subsidiary and Lishan Biotech entered into an exclusive worldwide licensing agreement for BMC128 (designated as LS-LBP-002 by Lishan Biotech), a first-in-class microbiome-based therapeutic designed to enhance anti-tumor immune activity. BMC128 was developed by Biomica and is currently completing a Phase 1 clinical study, showing promising early clinical results.

BMC128 is a live biopharmaceutical consortium composed of four human gut bacterial strains with defined functional capabilities that enhance responses to immunotherapy and stimulate anti-tumor immune activity. BMC128 is currently completing a Phase 1 clinical study in renal cell carcinoma and non-small cell lung cancer and has demonstrated encouraging early clinical promise. Results to date show an excellent safety and tolerability profile, together with early signs of efficacy, including a high proportion of patients with previously progressive disease achieving stable disease during treatment.

Under the agreement, Lishan Biotech will assume responsibility for global clinical development, manufacturing, and commercialization of BMC128. Biomica will be eligible to receive development milestone payments and royalties on future commercial sales, in accordance with an agreed-upon schedule.

Lishan Biotech plans to advance BMC128 into a Phase 2 clinical study and to pursue regulatory filings in both China and the United States for future commercialization.

Dr. Weijie Chen, Chairman of Lishan Biotech, stated: "This collaboration ensures that BMC128 continues to advance toward its next clinical milestones. We are impressed by the effects observed with BMC128 in lung and renal cancer patients who had experienced disease progression prior to treatment, and we look forward to advancing the program through further development and ultimately toward commercialization, for the benefit of cancer patients worldwide."

Ofer Haviv, CEO of Evogene and Biomica, commented: "We are pleased to partner with Lishan Biotech as BMC128 enters its next phase of development. Lishan Biotech’s strong development capabilities and commitment to innovative microbiome-based therapeutics position this program for meaningful value creation in difficult-to-treat cancers. As a major shareholder of Biomica, Evogene expects to benefit from BMC128’s future success."

Dr. Jing Bao, MD, a Director (Board Member) of Biomica Ltd with a PhD from the Weizmann Institute of Science, stated: "We are very pleased to see the execution of this meaningful and impactful collaboration agreement. This partnership brings together China’s clinical development capabilities with Israel’s innovation in microbiome science. We believe the success of this project will benefit patients worldwide and contribute to important breakthroughs in microbiome-based therapeutics."

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(Press release, Evogene, FEB 4, 2026, View Source [SID1234662469])