Novartis reports strong Q2 with double-digit sales growth and core margin expansion; raises FY 2025 core operating income guidance

On July 17, 2025 Vas Narasimhan, CEO of Novartis, reporting on Q2 2025 results, said (Press release, Novartis, JUL 17, 2025, View Source [SID1234654425]):

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!

"Novartis delivered another strong quarter, with double-digit sales and core operating income growth. We continue to drive strong performance on our ongoing launches for Kisqali, Pluvicto, and Scemblix, demonstrating the replacement power in our portfolio. We also delivered important pipeline milestones including a third positive Phase III readout for Pluvicto in hormone-sensitive prostate cancer and global filings for OAV101 IT in SMA. Our robust balance sheet and confidence in our mid and long-term growth enable us to initiate an up-to USD 10 billion share buyback as part of our commitment to balanced capital allocation."

Key figures


Q2 2025
Q2 2024
% change
H1 2025
H1 2024
% change

USD m
USD m
USD
cc

USD m
USD m
USD
cc
Net sales
14 054
12 512
12
11

27 287
24 341
12
13
Operating income
4 864
4 014
21
25

9 527
7 387
29
33
Net income
4 024
3 246
24
26

7 633
5 934
29
31
EPS (USD)
2.07
1.60
29
32

3.91
2.91
34
37
Free cash flow
6 333
4 615
37


9 724
6 653
46

Core operating income
5 925
4 953
20
21

11 500
9 490
21
24
Core net income
4 710
4 008
18
19

9 192
7 689
20
22
Core EPS (USD)
2.42
1.97
23
24

4.69
3.77
24
27

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 40 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.

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

1.
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
2.
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
3.
Strengthen foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.

Financials

Second quarter

Net sales were USD 14.1 billion (+12%, +11% cc), with volume contributing 12 percentage points to growth. Generic competition had a negative impact of 2 percentage points, pricing had a positive impact of 1 percentage point, and currency had a positive impact of 1 percentage point.

Operating income was USD 4.9 billion (+21%, +25% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches and net expense from legal matters.

Net income was USD 4.0 billion (+24%, +26% cc), mainly driven by higher operating income, partly offset by higher net financial expense. EPS was USD 2.07 (+29%, +32% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 5.9 billion (+20%, +21% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 42.2% of net sales, increasing 2.6 percentage points (3.4 percentage points cc).

Core net income was USD 4.7 billion (+18%, +19% cc), mainly due to higher core operating income, partly offset by higher income taxes and net financial expense. Core EPS was USD 2.42 (+23%, +24% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 6.3 billion (+37% USD), compared with USD 4.6 billion in the prior-year quarter, driven by higher net cash flows from operating activities.

First half

Net sales were USD 27.3 billion (+12%, +13% cc), with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 2 percentage points, pricing had a positive impact of 1 percentage point, benefiting from revenue deduction adjustments mainly in the US, and currency had a negative impact of 1 percentage point.

Operating income was USD 9.5 billion (+29%, +33% cc), mainly driven by higher net sales and contingent consideration adjustments, partly offset by higher investments behind priority brands and launches.

Net income was USD 7.6 billion (+29%, +31% cc), mainly driven by higher operating income, partly offset by higher income taxes and net financial expense. EPS was USD 3.91 (+34%, +37% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 11.5 billion (+21%, +24% cc), mainly driven by higher net sales, partly offset by higher investments behind priority brands and launches. Core operating income margin was 42.1% of net sales, increasing 3.1 percentage points (3.7 percentage points cc).

Core net income was USD 9.2 billion (+20%, +22% cc), mainly due to higher core operating income, partly offset by higher income taxes and net financial expense. Core EPS was USD 4.69 (+24%, +27% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow amounted to USD 9.7 billion (+46% USD), compared with USD 6.7 billion in the prior-year period, driven by higher net cash flows from operating activities.

Q2 priority brands

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q2 growth) including:

Kisqali
(USD 1 177 million, +64% cc) sales grew strongly across all regions, including +100% growth in the US with strong momentum from the recently launched early breast cancer indication as well as continued share gains in metastatic breast cancer
Entresto
(USD 2 357 million, +22% cc) sustained robust, demand-led growth globally
Kesimpta
(USD 1 077 million, +33% cc) sales grew across all regions driven by increased demand and strong access
Scemblix
(USD 298 million, +79% cc) sales grew across all regions, demonstrating the continued high unmet need in CML and continued strong momentum from the recently launched early-line indication in the US
Leqvio
(USD 298 million, +61% cc) continued steady growth, with a focus on increasing account and patient adoption, and continuing medical education
Pluvicto
(USD 454 million, +30% cc) showed encouraging demand uptake in the US following the pre-taxane metastatic castration-resistant prostate cancer (mCRPC) approval, as well as continued access expansion ex-US in the post-taxane mCRPC setting
Cosentyx
(USD 1 629 million, +6% cc) sales grew mainly in the US and Europe, driven by recent launches as well as volume growth in core indications
Fabhalta
(USD 120 million) sales grew driven by continued launch execution across all markets in PNH as well as recent launches in IgAN and C3G in the US
Lutathera
(USD 207 million, +17% cc) sales grew mainly in the US, Europe and Japan due to increased demand and earlier-line adoption, particularly in the US and Japan
Zolgensma
(USD 297 million, -17% cc) sales declined reflecting a lower incidence of SMA compared to prior year, while demand remained robust

Net sales of the top 20 brands in the second quarter and first half


Q2 2025
% change
H1 2025
% change

USD m
USD
cc
USD m
USD
cc
Entresto
2 357
24
22
4 618
22
22
Cosentyx
1 629
7
6
3 163
11
11
Kisqali
1 177
64
64
2 133
59
60
Kesimpta
1 077
35
33
1 976
38
38
Tafinlar + Mekinist
573
10
7
1 125
13
13
Promacta/Revolade
502
-8
-9
1 048
-2
-1
Jakavi
524
11
8
1 016
7
8
Xolair
443
4
2
899
9
10
Ilaris
477
30
27
896
24
24
Pluvicto
454
32
30
825
26
26
Tasigna
327
-27
-27
704
-16
-15
Zolgensma
297
-15
-17
624
-3
-3
Sandostatin Group
303
-3
-3
620
-7
-6
Leqvio
298
64
61
555
67
66
Scemblix
298
82
79
536
79
78
Lutathera
207
18
17
400
16
16
Exforge Group
191
7
7
370
0
3
Lucentis
173
-37
-39
362
-39
-38
Diovan Group
154
-4
-4
304
1
3
Galvus Group
123
-18
-17
247
-17
-14
Top 20 brands total
11 584
16
14
22 421
16
17

R&D update – key developments from the second quarter

New approvals
Vanrafia
(atrasentan)
FDA granted accelerated approval for Vanrafia for the reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression. Vanrafia can be seamlessly added to supportive care in IgAN and used as a foundational therapy.
Coartem
(artemether and lumefantrine)
In July, Swissmedic approved Coartem Baby, the first clinically proven malaria treatment specifically designed for newborns and infants between 2-5 kg. This milestone paves the way for registration in eight African countries through the Marketing Authorization for Global Health Products (MAGHP) procedure.

Regulatory updates
OAV101 IT (onasemnogene abeparvovec)
Regulatory submissions for OAV101 IT in patients with spinal muscular atrophy (SMA) were completed in the US and EU.

Results from ongoing trials and other highlights
Pluvicto
(lutetium Lu177 vipivotide tetraxetan)
At a prespecified interim analysis, the Phase III PSMAddition trial in PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC) met its primary endpoint with a statistically significant and clinically meaningful benefit in radiographic progression-free survival (rPFS) in patients treated with Pluvicto plus standard of care (SoC) versus SoC alone. The study also showed a positive trend in overall survival in favor of the Pluvicto arm. Data will be presented at an upcoming medical meeting and, based on FDA feedback, submitted for regulatory review in H2 2025.
Cosentyx
(secukinumab)
In the Phase III GCAptAIN study, Cosentyx did not demonstrate a statistically significant improvement in sustained remission compared to placebo in adults with newly diagnosed or relapsing giant cell arteritis (GCA). Safety in GCA was consistent with the known safety profile of Cosentyx.
Kisqali
(ribociclib)
A new subgroup analysis of the Phase III NATALEE trial in HR+/HER2- early breast cancer (eBC) showed that patients receiving Kisqali plus endocrine therapy continued to see consistent reductions in risk of recurrence across all efficacy measures, regardless of age and menopausal status, at median follow-up of 44.2 months. Data presented at ASCO (Free ASCO Whitepaper).
Fabhalta
(iptacopan)
In the Phase IIIb APPULSE-PNH study, adult PNH patients with hemoglobin (Hb) levels ≥10g/dL who switched to Fabhalta from anti-C5 therapies experienced clinically meaningful improvements in Hb levels. The vast majority (92.7%) achieved Hb ≥12g/dL, reaching normal or near-normal levels. No patients treated with Fabhalta required transfusions, experienced breakthrough hemolysis or had any major adverse vascular events during the treatment period. Data presented at EHA (Free EHA Whitepaper).
Scemblix (asciminib)
In the Phase IIIb ASC4START trial evaluating the tolerability and efficacy of Scemblix versus nilotinib in adult patients with newly diagnosed Ph+ CML-CP, patients treated with Scemblix had a 55% lower risk of discontinuation due to AEs vs nilotinib, and 12.7% more patients treated with Scemblix achieved major molecular responses by week 12 vs those treated with nilotinib. Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).
Votoplam
The Phase II PIVOT-HD study of votoplam in patients with Stage 2 and Stage 3 Huntington’s disease met its primary endpoint of reduction in blood Huntingtin (HTT) protein levels at Week 12 (p<0.0001), with durable, dose-dependent lowering observed through Month 12. Across all dose levels and disease stages, votoplam showed a favorable safety and tolerability profile, with no treatment-related serious adverse events or neurofilament light chain protein (NfL) spikes. Together with our partner, PTC Therapeutics, we are evaluating the results and plan to engage with the HD community and regulatory authorities to inform next steps.
Remibrutinib
A Phase II study with remibrutinib in food allergy met its primary endpoint with a statistically significant and clinically meaningful benefit. These data support remibrutinib’s potential as a first-in-class oral BTK inhibitor that reduces the risk of severe allergic reactions, including anaphylaxis. Phase III study planning is underway.
Ianalumab
Novartis will not advance investigation of ianalumab in hidradenitis suppurativa following a Phase II proof-of-concept study which did not meet our target criteria despite demonstrating efficacy vs placebo. No new safety signals were observed and all other studies for ianalumab in B-cell driven diseases continue as planned.
Rapcabtagene autoleucel (YTB323)
A Phase I/II study of rapcabtagene autoleucel, a rapidly manufactured CD19 CAR-T therapy using the T-Charge platform, demonstrated the expansion of CAR-T cells, deep B cell depletion, early and sustained improvement in overall disease activity, and a favorable benefit/risk profile in 21 patients with severe refractory SLE up to 12 months after treatment. Data presented at EULAR.

Zigakibart
Updated results from the Phase I/II study for zigakibart in IgAN showed a robust and clinically meaningful reduction in proteinuria of 60.4% from baseline and eGFR stabilization over 100 weeks of treatment. To date, this is the longest duration of treatment reported for an anti-APRIL agent, demonstrating long-term safety and efficacy. Data presented at ERA. The Phase III BEYOND trial is ongoing with anticipated readout in 2026.
Selected transactions
Novartis has completed the acquisition of Regulus Therapeutics, a clinical-stage biopharmaceutical company focused on developing microRNA therapeutics. Regulus’ lead asset, farabursen, is a potential first-in-class oligonucleotide targeting miR-17 for the treatment of autosomal dominant polycystic kidney disease (ADPKD) that recently completed Phase Ib. The acquisition is aligned with the therapeutic area focus of Novartis and leverages its strength and expertise in renal disease.

In July, Novartis entered into an agreement with Sironax, granting Novartis an exclusive option to acquire its Brain Delivery Module (BDM) platform, a differentiated blood-brain-barrier crossing technology designed to enhance the brain delivery of therapeutics of various modalities.

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 half of 2025, Novartis repurchased a total of 48.8 million shares for USD 5.3 billion on the SIX Swiss Exchange second trading line under the USD 15 billion share buyback (announced in July 2023 and completed on July 1, 2025, with a total of 140.9 million shares repurchased over this period). In addition, 1.6 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 11.2 million shares (equity value of USD 0.6 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the dilutive impact from equity-based compensation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 39.2 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 4.9 billion and a net cash outflow of USD 5.4 billion.

Net debt increased to USD 23.8 billion at June 30, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 9.7 billion being more than offset by the USD 7.8 billion annual dividend payment, cash outflows for treasury share transactions of USD 5.4 billion and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 3.1 billion.

As of Q2 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

Key assumption:

We continue to assume Entresto US generic entry in mid-2025 for forecasting purposes, though timing of generic entry is subject to ongoing IP and regulatory litigation

Foreign exchange impact

If mid-July exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be positive 1 percentage point on net sales and negative 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Key figures1


Q2 2025
Q2 2024
% change
H1 2025
H1 2024
% change

USD m
USD m
USD
cc

USD m
USD m
USD
cc
Net sales
14 054
12 512
12
11

27 287
24 341
12
13
Operating income
4 864
4 014
21
25

9 527
7 387
29
33
As a % of sales
34.6
32.1


34.9
30.3

Net income
4 024
3 246
24
26

7 633
5 934
29
31
EPS (USD)
2.07
1.60
29
32

3.91
2.91
34
37
Net cash flows from operating activities
6 664
4 875
37


10 309
7 140
44

Non-IFRS measures

Free cash flow
6 333
4 615
37


9 724
6 653
46

Core operating income
5 925
4 953
20
21

11 500
9 490
21
24
As a % of sales
42.2
39.6


42.1
39.0

Core net income
4 710
4 008
18
19

9 192
7 689
20
22
Core EPS (USD)
2.42
1.97
23
24

4.69
3.77
24
27

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 40 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.

NKGen Biotech and HekaBio Enter Strategic Partnership to Bring Novel NK Cell Therapy to Japan

On July 17, 2025 NKGen Biotech, Inc. (OTC: NKGN) ("NKGen" or the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ("NK") cell therapeutics, and HekaBio K.K., headquartered in Chuo-ku, Tokyo ("HekaBio"), reported a strategic partnership to accelerate the regulatory, manufacturing and commercial development of NKGen’s autologous NK cell therapy, troculeucel, in Japan following HekaBio’s recently announced investment in common equity of NKGen (Press release, NKGEN Biotech, JUL 17, 2025, View Source [SID1234654424]).

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!

HekaBio will lead all clinical trials in Japan and oversee all regulatory activities with Japan’s Pharmaceuticals and Medical Devices Agency for pre-market approval of troculeucel in several neurodegenerative disease indications, including Alzheimer’s and Parkinson’s Diseases.

As troculeucel is an autologous, non-genetically modified cell therapy, there is allowance under regenerative medicine regulations in Japan to offer this therapy to patients on an accelerated path, much faster than in other major markets. HekaBio will fully leverage the regulation and its domestic strategic partner network, aiming for first dosing in Japanese patients over the next 12 months. Beyond intractable disease, troculeucel has the potential to also support Japan’s aging population in the longevity/wellness space.

"Japan has always had an advanced progressive health care system where great attention has been placed on the use of novel autologous cell therapies for prevention, longevity, and wellness as well as for the treatment of more chronic illnesses," said Paul Y. Song, MD, Chairman and Chief Executive Officer ("CEO") of NKGen. "I am convinced that HekaBio’s clinical, regulatory, and commercial expertise will guide us to satisfy all regulatory requirements, find the best local manufacturing partner to make our therapy readily available, and ultimately develop the best commercial strategy for Japan. We are very excited to partner with HekaBio."

"Dementia, particularly Alzheimer’s Disease, and other neurodegenerative diseases together present significant health and social challenges in Japan due to the country’s aging population. We are very excited about our partnership with NKGen and look forward to advancing troculeucel for the benefit of patients and society," said Rob Claar, CEO of HekaBio.

GSK provides update on US FDA advisory committee review of Blenrep (belantamab mafodotin-blmf) combinations for patients with relapsed/refractory multiple myeloma

On July 17, 2025 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of Blenrep (belantamab mafodotin-blmf) combinations (Press release, GlaxoSmithKline, JUL 17, 2025, View Source [SID1234654423]). The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

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!

The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July 2025 PDUFA date.

GSK remains confident in the benefit/risk profile of Blenrep (belantamab mafodotin-blmf) and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival.

Blenrep combinations are approved in relapsed or refractory multiple myeloma in the UK1 and Japan2, as well as other markets, including Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the European Union3, and China4 (based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

About multiple myeloma
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.5,6 There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.7 Multiple myeloma is a significant and enduring health concern in the US, where more than 35,000 cases were diagnosed in 2024.8 Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.9 Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.10,11

About Blenrep
Blenrep is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group.

Indication
Blenrep combinations were approved in relapsed or refractory multiple myeloma in the UK in April 2025 and in Japan in May 2025. Applications are currently under review in all major markets.

In the UK, Blenrep is indicated in adults for the treatment of multiple myeloma:

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and
in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.
IMPORTANT SAFETY INFORMATION FOR BLENREP
More information can be found in the Blenrep Summary of Product Characteristics and Patient Information leaflets available on the MHRA Products website.12

About DREAMM-7
DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy. The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was progression-free survival (PFS) as per an independent review committee, with secondary endpoints including overall survival (OS), duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing. Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes.

In DREAMM-7, BVd nearly tripled median PFS versus DVd (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001). DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring BVd (n=243) versus DVd (n=251) (HR 0.58; 95% CI: 0.43-0.79; p=0.00023). The three-year OS rate was 74% in the BVd arm and 60% in the DVd arm.

PFS results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Plenary Series in February 2024 and published in the New England Journal of Medicine. OS results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2024.13,14

About DREAMM-8
DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy. The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing. Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes.

At the primary analysis at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the Blenrep combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5). A positive OS trend was observed but not statistically significant (HR: 0.77 [95% CI: 0.53-1.14]) at the interim analysis. OS follow-up continues and further analyses are planned.

With additional follow-up, a clinically meaningful benefit continued to be observed, with a near-tripling of the median PFS for the Blenrep combination versus the bortezomib combination (32.6 months versus 12.5 months, respectively (HR: 0.49 [95% CI: 0.35-0.68]). At the end of one year, 71% (95% CI: 63-78) of patients in the BPd combination group compared to 51% (95% CI: 42-60) in the PVd combination group were alive and had not progressed. A benefit for BPd was observed across all pre-specified subgroups including those with poor prognostic features, such as patients who were refractory to lenalidomide and patients with high-risk cytogenetics.

Results were first presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting and published in the New England Journal of Medicine.15 Updated PFS results were presented at European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) 2025.

I-Mab Strengthens Givastomig Intellectual Property Portfolio through Acquisition of Bridge Health

On July 17, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported that it entered into a definitive agreement to acquire 100% ownership of Bridge Health Biotech Co., Ltd. (Bridge Health) (Press release, I-Mab Biopharma, JUL 17, 2025, View Source [SID1234654422]). The transaction provides I-Mab with the rights to bispecific and multi-specific applications (including bispecific and multi-specific antibodies and antibody drug conjugates (ADCs)), based on the Claudin 18.2 (CLDN18.2) parental antibody used in the Company’s CLDN18.2 x 4-1BB bispecific antibody, givastomig.

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!

"Advancing givastomig is I-Mab’s top priority. The strategic acquisition of Bridge Health emphasizes I-Mab’s focus on enhancing the value of givastomig. With this transaction, I-Mab has further enriched the potential value of givastomig by strengthening upstream intellectual property rights, reducing future milestone payments, and unencumbering givastomig of future royalties," said Sean Fu, PhD, MBA, Chief Executive Officer of I-Mab. "Positive Phase 1b dose escalation data recently presented at ESMO (Free ESMO Whitepaper) GI 2025 has enhanced our confidence that givastomig has the potential to be a best-in-class CLDN18.2-directed therapy for gastric cancers and beyond. Continued clinical trial momentum has enabled faster than expected enrollment in the Phase 1b dose expansion cohorts, and we now expect to provide a topline readout in Q1 of 2026."

The CLDN18.2 parental antibody utilized in givastomig has been observed to show a higher affinity to human CLDN18.2 than other antibodies, including antibodies used in approved CLDN18.2-directed therapies. Additionally, the CLDN18.2 parental antibody has been observed to exhibit stronger binding affinity to cell lines expressing high, medium and even low levels of CLDN18.2. These characteristics are believed to be core to the differentiation of givastomig as a potential best-in-class, bispecific antibody designed to treat Claudin 18.2-positive cancers.

Givastomig is in development for the treatment of first line metastatic gastric cancers, with potential to expand into other solid tumors. Recently presented positive data from a Phase 1b dose escalation immunochemotherapy combination study showed an 83% objective response rate (ORR) in the doses selected for dose expansion cohorts, with favorable overall tolerability. I-Mab expects to present topline results from the Phase 1b dose expansion combination study in Q1 of 2026.

Transaction Terms

Under the terms of the agreement, I-Mab will pay Bridge Health shareholders an upfront payment of $1.8 million and non-contingent payments of $1.2 million through 2027. In addition, Bridge Health shareholders may receive future milestone payments of up to $3.875 million, subject to the achievement of certain development and regulatory milestones. The transaction is expected to close in Q3 of 2025.

Sidley Austin LLP served as legal advisor to I-Mab in connection with the transaction.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line (1L) metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

An ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Data from the dose escalation cohorts (n=17), presented at the European Society for Medical Oncology Gastrointestinal Cancers Congress (ESMO GI 2025) showed an 83% objective response rate (ORR) at doses selected for dose expansion, with responses in patients with low PD-L1 and CLDN18.2 expression. Responses were rapid, durable and deepened over time, with a favorable overall safety profile. Enrollment in the first dose expansion cohort (n=20) finished ahead of schedule and enrollment in the second dose expansion cohort (n=20) is nearly complete. Topline data are expected in Q1 of 2026.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights equally with ABL Bio, excluding Greater China and South Korea.

Abbott Reports Second-Quarter 2025 Results

On July 17, 2025 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2025 (Press release, Abbott, JUL 17, 2025, View Source [SID1234654420]).

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!

Second-quarter sales increased 7.4 percent on a reported basis, 6.9 percent on an organic basis, or 7.5 percent when excluding COVID-19 testing-related sales1.
Second-quarter GAAP diluted EPS of $1.01 and adjusted diluted EPS of $1.26, which excludes specified items and reflects double-digit growth compared to the prior year.
First-half sales increased 5.7 percent on a reported basis, 6.9 percent on an organic basis, or 7.9 percent when excluding COVID-19 testing-related sales2.
Abbott projects full-year 2025 organic sales growth, excluding COVID-19 testing-related sales, to be 7.5% to 8.0%, or 6.0% to 7.0% when including COVID-19 testing-related sales.
Abbott projects full-year 2025 adjusted diluted EPS of $5.10 to $5.20, which reflects double-digit growth at the midpoint.
In April, Abbott completed enrollment ahead of schedule in its FlexPulse U.S. IDE trial, which is designed to evaluate the TactiFlex Duo Pulsed Field Ablation (PFA) System for treating patients with heart rhythm disorders such as atrial fibrillation (AFib).
In April, Abbott announced late-breaking data from the AVEIR Conduction System Pacing (CSP) clinical feasibility study. This study was the world’s first assessment of a leadless pacemaker delivering conduction pacing, which produces pacing that closely mimics the heart’s natural electrical rhythm and represents a new treatment option for people with irregular heart rhythms.
In May, Abbott announced U.S. Food and Drug Administration (FDA) approval of the company’s Tendyne transcatheter mitral valve replacement (TMVR) system, a first-of-its-kind device to help treat people with mitral valve disease.
Abbott has initiated plans to develop a new cardiovascular device manufacturing facility in the state of Georgia to be completed by 2028.
"Halfway through the year, we delivered high single-digit organic sales growth, double-digit EPS growth, significantly expanded our margin profiles, and continued to advance key programs through our new product pipeline," said Robert B. Ford, chairman and chief executive officer, Abbott. "We see this momentum carrying into 2026."

SECOND-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes thatmeasuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to bestunderstand the underlying performance of the company as the demand for COVID-19 tests has significantly declined following the transition from a pandemic to endemic phase.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,276

957

811

2,503

International

6,866

1,255

1,362

1,383

2,866

Total reported

11,142

2,212

2,173

1,383

5,369

% Change vs. 2Q24

U.S.

8.7

2.6

(0.1)

n/a

14.6

International

6.6

3.1

(1.5)

6.9

12.4

Total reported

7.4

2.9

(1.0)

6.9

13.4

Impact of foreign exchange

0.5

(0.5)

0.4

(0.8)

1.2

Organic

6.9

3.4

(1.4)

7.7

12.2

Impact of COVID-19 testing sales 1

(0.6)

(2.2)

Organic (excluding COVID-19 tests)

7.5

3.4

0.8

7.7

12.2

Organic

U.S.

8.7

2.6

(0.1)

n/a

14.6

International

5.8

4.0

(2.2)

7.7

10.1

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

8,444

1,912

1,682

4,842

International

13,056

2,446

2,545

2,643

5,422

Total reported

21,500

4,358

4,227

2,643

10,264

% Change vs. 1H24

U.S.

8.5

5.6

(3.5)

n/a

14.8

International

3.9

1.6

(4.5)

4.9

9.1

Total reported

5.7

3.3

(4.1)

4.9

11.7

Impact of foreign exchange

(1.1)

(1.5)

(0.9)

(2.9)

(0.7)

Impact of business exit*

(0.1)

(0.3)

Organic

6.9

5.1

(3.2)

7.8

12.4

Impact of COVID-19 testing sales 2

(1.0)

(3.9)

Organic (excluding COVID-19 tests)

7.9

5.1

0.7

7.8

12.4

Organic

U.S.

8.7

6.4

(3.5)

n/a

14.8

International

5.8

4.1

(3.0)

7.8

10.3

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Nutrition

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

957

587

370

International

1,255

467

788

Total reported

2,212

1,054

1,158

% Change vs. 2Q24

U.S.

2.6

4.2

0.2

International

3.1

(5.7)

9.2

Total reported

2.9

(0.4)

6.1

Impact of foreign exchange

(0.5)

(0.6)

(0.5)

Organic

3.4

0.2

6.6

U.S.

2.6

4.2

0.2

International

4.0

(4.5)

9.8

Worldwide Nutrition sales increased 2.9 percent on a reported basis and 3.4 percent on an organic basis in the second quarter.

Growth in the quarter was led by Adult Nutrition, where global sales increased 6.1 percent on a reported basis and 6.6 percent on an organic basis, led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading brand of products designed to meet the nutritional requirements for people with diabetes.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Pediatric

Adult

U.S.

1,912

1,175

737

International

2,446

920

1,526

Total reported

4,358

2,095

2,263

% Change vs. 1H24

U.S.

5.6

9.0

0.6

International

1.6

(7.0)

7.7

Total reported

3.3

1.3

5.3

Impact of foreign exchange

(1.5)

(1.2)

(1.6)

Impact of business exit*

(0.3)

(0.7)

Organic

5.1

2.5

7.6

U.S.

6.4

9.0

2.4

International

4.1

(4.6)

10.2

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Diagnostics

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

811

351

35

104

321

International

1,362

1,007

88

44

223

Total reported

2,173

1,358

123

148

544

% Change vs. 2Q24

U.S.

(0.1)

7.3

5.5

(2.0)

(7.1)

International

(1.5)

0.5

(5.6)

(11.9)

(6.1)

Total reported

(1.0)

2.2

(2.7)

(5.1)

(6.7)

Impact of foreign exchange

0.4

0.6

0.7

0.1

0.1

Organic

(1.4)

1.6

(3.4)

(5.2)

(6.8)

U.S.

(0.1)

7.3

5.5

(2.0)

(7.1)

International

(2.2)

(0.3)

(6.5)

(12.1)

(6.3)

Global Diagnostics sales decreased 1.0 percent on a reported basis, decreased 1.4 percent on an organic basis, and increased 0.8 percent when excluding COVID-19 testing-related sales1.

Diagnostics sales growth was impacted by the year-over-year decline in COVID-19 testing-related sales and volume-based procurement programs in China.

COVID-19 testing-related sales were $55 million in the quarter, compared to $102 million in the second quarter of the prior year.

Global Core Laboratory Diagnostics sales increased 2.2 percent on a reported basis and increased 1.6 percent on an organic basis. Growth in the quarter was impacted by volume-based procurement programs in China.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

1,682

683

75

204

720

International

2,545

1,852

170

86

437

Total reported

4,227

2,535

245

290

1,157

% Change vs. 1H24

U.S.

(3.5)

7.2

(0.3)

(12.8)

International

(4.5)

(2.4)

(6.1)

(4.5)

(12.3)

Total reported

(4.1)

0.1

(4.4)

(1.6)

(12.6)

Impact of foreign exchange

(0.9)

(1.2)

(1.0)

(0.4)

(0.6)

Organic

(3.2)

1.3

(3.4)

(1.2)

(12.0)

U.S.

(3.5)

7.2

(0.3)

(12.8)

International

(3.0)

(0.7)

(4.9)

(3.3)

(10.7)

Established Pharmaceuticals

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

1,383

1,059

324

Total reported

1,383

1,059

324

% Change vs. 2Q24

U.S.

n/a

n/a

n/a

International

6.9

7.3

5.9

Total reported

6.9

7.3

5.9

Impact of foreign exchange

(0.8)

(1.4)

1.4

Organic

7.7

8.7

4.5

U.S.

n/a

n/a

n/a

International

7.7

8.7

4.5

Established Pharmaceuticals sales increased 6.9 percent on a reported basis and 7.7 percent on an organic basis in the second quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies increased 7.3 percent on a reported basis and 8.7 percent on an organic basis, led by double-digit growth in several countries across Asia, Latin America and the Middle East.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

2,643

2,024

619

Total reported

2,643

2,024

619

% Change vs. 1H24

U.S.

n/a

n/a

n/a

International

4.9

5.7

2.4

Total reported

4.9

5.7

2.4

Impact of foreign exchange

(2.9)

(3.3)

(1.4)

Organic

7.8

9.0

3.8

U.S.

n/a

n/a

n/a

International

7.8

9.0

3.8

Medical Devices

Second Quarter 2025 Results (2Q25)

Sales 2Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,503

340

322

282

283

289

193

794

International

2,866

333

378

86

474

347

61

1,187

Total reported

5,369

673

700

368

757

636

254

1,981

% Change vs. 2Q24

U.S.

14.6

16.5

12.2

15.8

3.0

12.2

0.4

24.5

International

12.4

5.7

10.9

11.2

5.4

13.7

20.4

17.5

Total reported

13.4

10.9

11.5

14.7

4.5

13.0

4.6

20.2

Impact of foreign exchange

1.2

1.1

1.2

0.7

1.0

1.3

0.3

1.7

Organic

12.2

9.8

10.3

14.0

3.5

11.7

4.3

18.5

U.S.

14.6

16.5

12.2

15.8

3.0

12.2

0.4

24.5

International

10.1

3.6

8.8

8.4

3.8

11.4

18.7

14.7

Worldwide Medical Devices sales increased 13.4 percent on a reported basis and 12.2 percent on an organic basis in the second quarter.

Sales growth in the quarter was led by double-digit growth in Diabetes Care, Heart Failure, Structural Heart and Electrophysiology.

Several products contributed to the strong performance, including FreeStyle Libre, Navitor, TriClip and AVEIR.

In Diabetes Care, sales of continuous glucose monitors were $1.9 billion and grew 21.4 percent on a reported basis and 19.6 percent on an organic basis.

First Half 2025 Results (1H25)

Sales 1H25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

4,842

644

621

544

551

571

369

1,542

International

5,422

614

708

163

916

642

113

2,266

Total reported

10,264

1,258

1,329

707

1,467

1,213

482

3,808

% Change vs. 1H24

U.S.

14.8

14.4

11.7

13.2

4.2

16.3

(1.1)

25.7

International

9.1

1.2

7.6

12.6

3.5

9.3

18.5

13.8

Total reported

11.7

7.6

9.5

13.1

3.8

12.5

2.9

18.4

Impact of foreign exchange

(0.7)

(0.4)

(0.6)

(0.2)

(0.7)

(0.7)

(0.4)

(0.7)

Organic

12.4

8.0

10.1

13.3

4.5

13.2

3.3

19.1

U.S.

14.8

14.4

11.7

13.2

4.2

16.3

(1.1)

25.7

International

10.3

2.0

8.8

13.4

4.8

10.5

20.5

15.0

ABBOTT’S FINANCIAL GUIDANCE
Abbott projects full-year 2025 organic sales growth, excluding COVID-19 testing related sales, to be 7.5% to 8.0%, or 6.0% to 7.0% when including COVID-19 testing-related sales.

Abbott projects full-year 2025 adjusted operating margin to be approximately 23.5% of sales.

Abbott projects full-year 2025 adjusted diluted earnings per share of $5.10 to $5.20 and third-quarter 2025 adjusted diluted earnings per share of $1.28 to $1.32.

Abbott has not provided the related GAAP financial measures on a forward-looking basis for these forward-looking non-GAAP financial measures because the company is unable to predict with reasonable certainty and without unreasonable effort the timing and impact of certain items such as restructuring and cost reduction initiatives, charges for intangible asset impairments, acquisition-related expenses, and foreign exchange, which could significantly impact Abbott’s results in accordance with GAAP.

ABBOTT DECLARES 406th CONSECUTIVE QUARTERLY DIVIDEND
On June 13, 2025, the board of directors of Abbott declared the company’s quarterly dividend of $0.59 per share. Abbott’s cash dividend is payable Aug. 15, 2025, to shareholders of record at the close of business on July 15, 2025.

Abbott has increased its dividend payout for 53 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.