INVESTOR

Nurix Therapeutics Announces First Patient Enrolled in Registrational Phase 3 DAYBreak CLL-306 Trial of Bexobrutideg in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Tue, 04 Aug 2026 05:15:00 GMT

Dear Investor,

Please find attached a press release from our partner Nurix Therapeutics:
https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-announces-first-patient-enrolled/

Do not hesitate to contact us for any further questions.

With best regards,

Roche Investor Relations
Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America
Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD)

Fri, 24 Jul 2026 10:15:00 GMT

Susvimo is the first and only continuous delivery treatment that offers an alternative to standard of care eye injections for nAMD
Positive recommendation is based on data from the LADDER, Archway and Portal studies showing Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections^1-3
By continuously delivering medicine into the eye through the Contivue^® refillable implant, Susvimo may help people with nAMD maintain their vision with as few as two treatments per year^1-3
nAMD is a leading cause of blindness in people over the age of 60 and affects 1.7 million in the European Union (EU)⁴

Basel, 24 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Susvimo^® (ranibizumab injection) 100 mg/mL for the treatment of neovascular age-related macular degeneration (nAMD).⁵ Susvimo is intended for continuous release into the vitreous using the Contivue implant.⁶ A final decision is expected from the European Commission in the near future.

“The positive CHMP recommendation for Susvimo brings us closer to offering a new treatment option for people in Europe who currently face the burden of frequent eye injections,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By requiring only two refills per year, Contivue with Susvimo offers a continuous drug delivery approach intended to reduce the frequency of clinic visits, with data from clinical trials supporting maintenance of vision up to seven years.”

In 2025, Roche was granted a CE mark for its Port Delivery Platform, known as Contivue in the European Union (EU), which comprises the eye implant through which Susvimo is delivered, and four ancillary devices to initially fill, insert, refill and remove the implant (if required). Contivue provides continuous delivery of Susvimo directly to the eye.⁶

The positive recommendation is based on data from three clinical studies in nAMD: one pivotal Phase III study, Archway, and two supportive studies, the Phase II LADDER study and the open-label long-term extension study Portal.^1-3 Data from Archway showed patients treated with Susvimo achieved and maintained vision outcomes equivalent to monthly intravitreal (IVT) ranibizumab injections, with longer-term data in Portal showing maintenance of vision up to seven years.^2,3 With two refills per year, approximately 95% of patients treated with Susvimo required no supplemental/additional anti-vascular endothelial growth factor (anti-VEGF) treatment.³ Susvimo was generally well tolerated over the longer term.^1-3

Contivue has been specifically engineered for use with Susvimo.⁶ Roche is evaluating other molecules in the pipeline that could potentially be used with the Port Delivery Platform to increase efficacy and/or durability, with the future aim of providing multiple treatment options to patients using Contivue.

About neovascular age-related macular degeneration
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or ‘wet’ AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.^7-9 It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.⁹ Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.^7,10,11

About Contivue with Susvimo (Port Delivery Platform with ranibizumab)
The Contivue devices include a refillable implant surgically inserted into the eye during a one-time, outpatient procedure. Contivue also includes four ancillary devices to initially fill, insert, refill, and remove the implant.⁶

Contivue with Susvimo delivers a customised formulation of ranibizumab, Susvimo, over time.⁶ Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.¹² The customised formulation of ranibizumab, Susvimo, delivered by Contivue with Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis^® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.¹³

In the US, the devices (refillable eye implant and ancillary devices) and medicine (customised formulation of ranibizumab) are approved by the Food and Drug Administration (FDA) as a single product, called Susvimo for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR).¹⁴

Contivue with Susvimo is also approved for the treatment of nAMD in Thailand.

About Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

*Lucentis^® (ranibizumab injection) was developed by Genentech, a member of the Roche Group. Genentech retains commercial rights in the United States and Novartis has exclusive commercial rights for the rest of the world.

All trademarks used or mentioned in this release are protected by law.

References
[1] Khanani et al. First-Time Long-Term Efficacy and Safety Outcomes of PDS Patients Enrolled in the Ladder Phase 2 Trial of PDS for nAMD Followed for up to ~7 Years. 4-7 September, EURETINA 2025.
[2] Holekamp NM, Campochiaro PA, Chang MA, et al. Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(3):295-307. doi:10.1016/j.ophtha.2021.09.016
[3] Kitchens J, et al. Five Year Outcomes in nAMD Patients Enrolled in the Archway Study and Treated With the PDS. Presented at: The American Society of Retina Specialists (ASRS) 2025 Annual Meeting; 2025 August 01; Long Beach, California, United States.
[4] Li et al. Retinal diseases in Europe. Prevalence, incidence and healthcare needs. August 2017 [Internet; cited July 2026]. Available from: https://euretina.org/resource/euretina-whitebook-on-prevalence-incidence-and-healthcare-needs-for-retinal-diseases-in-europe/
[5] Roche data on file.
[6] Roche. Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD). September 4, 2025. [Internet; cited July 2026]. Available from: https://www.roche.com/media/releases/med-cor-2025-09-04
[7] BrightFocus Foundation. Macular Degeneration Facts & Figures. [Internet; cited July 2026]. Available from: https://www.brightfocus.org/macular/facts-figures/
[8] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye Vis (Lond). 2016;3:34. doi:10.1186/s40662-016-0063-5
[9] Little K, Ma JH, Yang N, Chen M, Xu H. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-291. doi:10.1016/j.ebiom.2018.11.029
[10] Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014;2(2):e106-e116. doi:10.1016/S2214-109X(13)70145-1
[11] Connolly E, Rhatigan M, O'Halloran AM, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102(12):1691-1695. doi:10.1136/bjophthalmol-2017-311673
[12] Heier JS, Singh RP, Wykoff CC, et al. The angiopoietin/tie pathway in retinal vascular diseases: A review. Retina. 2021;41(1):1-19. doi:10.1097/IAE.0000000000003003
[13] European Medicines Agency. Lucentis (ranibizumab) Summary of Product Characteristics. May 2026. [Internet; cited July 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/lucentis-epar-product-information_en.pdf
[14] US Food and Drug Administration (FDA). Susvimo Prescribing Information. September 2025. [Internet; cited July 2026]. Available from: https://www.gene.com/download/pdf/susvimo_prescribing.pdf

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
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Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Investor Release Susvimo CHMP EN

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Thu, 23 Jul 2026 05:00:00 GMT

Group sales were +6% at constant exchange rates (CER)¹, -2% when reported in CHF and +8% in USD², in the first six months, driven by high demand for innovative medicines and diagnostics.
Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers.
Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions.
Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc.
Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc.
Highlights:
- US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys
- US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus
- Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II)
- Launch of Axelios 1, a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale
- EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection
- US approval for Ventana PTEN (SP218) RxDx Assay, the first companion diagnostic to assess the levels of a key protein in prostate cancer
- Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology
- Agreement to acquire PathAI to transform AI-driven diagnostics
Outlook for 2026 confirmed.

Outlook for 2026
Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.

Key figures	CHF millions		% change
January–June	2026	2025	At CER¹	In CHF	In USD
Group sales	30,364	30,944	6	-2	8
Pharmaceuticals Division	23,629	23,985	6	-1	8
Diagnostics Division	6,735	6,959	3	-3	6
Core operating profit	11,856	12,010	10	-1
Core EPS – diluted (CHF)	10.85	11.08	9	-2
IFRS operating profit	9,671	10,330	6	-6

Roche CEO Thomas Schinecker: “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development.

We reported positive phase III data for divarasib, reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews: giredestrant in early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer and Gazyva/Gazyvaro in two autoimmune kidney diseases.

In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective Axelios 1 sequencing solution, alongside EU CE mark for key diagnostic tests, including the Elecsys pTau217 blood test for Alzheimer’s pathology and the Elecsys IGRA TB blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide.

Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.”

Group results
In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates.

Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF).

IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc.

Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth.

The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025.

Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025.

In the United States, sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis).

Sales in Europe were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo.

In Japan, sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra.

Sales in the International region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales.

The Diagnostics Division’s sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China.

Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions.

In North America, sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas.

Sales in Asia-Pacific were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region.

In Latin America, sales were +10% at CER, or +5% when reported in CHF.

Pharmaceuticals: key developments

Compound	Milestone
Regulatory
Gazyva/Gazyvaro Several autoimmune diseases	FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years. More information: Media Release, 15 July 2026
Enspryng Thyroid eye disease	FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release, 30 June 2026
Lunsumio and Polivy Blood cancer	FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment. More information: Media release, 18 June 2026
Tecentriq Colon cancer	FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery. More information: Media Release, 11 June 2026
Giredestrant Breast cancer	FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026. More information: Media Release, 2 June 2026
Phase III, pivotal and other key read-outs
Divarasib Lung cancer	Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. More information: Media Release, 2 July 2026
Fenebrutinib Multiple sclerosis	Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS). More information: Media Release, 22 April 2026
Other
Alzheimer’s integrated portfolio presentation	Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care. More information: Media Release, 7 July 2026
Nurix Therapeutics collaboration	Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors. More information: Media Release, 8 June 2026
Obesity portfolio data presentation	Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option. More information: Media Release, 1 June 2026
Oncology portfolio data presentation	Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers. More information: Media Release, 19 May 2026
Ophthalmology portfolio data presentation	Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. More information: Media Release, 30 April 2026

Pharmaceuticals sales

Sales	CHF millions		As % of sales		% change
January–June	2026	2025	2026	2025	At CER	In CHF
Pharmaceuticals Division	23,629	23,985	100.0	100.0	6	-1
United States	12,229	12,670	51.8	52.8	6	-3
Europe	4,520	4,566	19.1	19.0	1	-1
Japan	1,360	1,425	5.8	5.9	11	-5
International	5,520	5,324	23.3	22.3	10	4

International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Top 20 best-selling pharmaceuticals	Total		United States		Europe		Japan		International
Top 20 best-selling pharmaceuticals	CHF m	%	CHF m	%	CHF m	%	CHF m	%	CHF m	%
Ocrevus Multiple sclerosis	3,470	7	2,300	2	758	10	-	-	412	30
Hemlibra Haemophilia A	2,492	11	1,313	9	502	4	171	9	506	26
Vabysmo Eye diseases (nAMD, DME, RVO)	2,059	8	1,333	1	386	5	75	26	265	65
Tecentriq Cancer immunotherapy	1,704	6	815	9	410	-3	146	-2	333	17
Xolair³ Chronic hives, food allergies	1,673	27	1,673	27	-	-	-	-	-	-
Perjeta³ Breast cancer	1,389	-7	551	-11	238	-14	24	-23	576	0
Phesgo Breast cancer	1,318	18	318	0	425	9	88	15	487	47
Actemra/RoActemra³ RA, COVID-19	1,074	-9	515	-9	238	-21	140	8	181	-3
Evrysdi Spinal muscular atrophy	968	17	323	15	335	17	39	-1	271	25
Kadcyla³ Breast cancer	916	-6	310	-14	248	-4	39	2	319	3
Polivy Blood cancer	808	20	381	28	128	-18	98	16	201	47
Alecensa Lung cancer	795	6	261	4	126	-4	93	8	315	13
MabThera/Rituxan³ Blood cancer, RA	609	5	402	14	62	-9	6	-11	139	-10
Activase/TNKase³ Cardiac diseases	555	11	531	11	-	-	-	-	24	12
Gazyva/Gazyvaro³ Blood cancer, lupus nephritis	489	7	240	4	117	-1	17	14	115	21
Herceptin³ Breast and gastric cancer	462	-12	94	-14	136	-7	2	-36	230	-14
Avastin³ Various cancer types	414	-15	125	-12	35	37	36	-44	218	-13
Pulmozyme³ Cystic fibrosis	204	-8	145	-5	29	-11	-	26	30	-18
Columvi Blood cancer	196	70	91	28	53	116	-	-	52	173
Enspryng Acute inflammation of brain, spinal cord and optic nerves	195	22	50	20	23	20	79	18	43	37

DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis

Diagnostics: key developments

Product	Milestone
cobas HDV test	Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. More information: Media Release, 14 July 2026
Elecsys IGRA TB test	Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient. More information: Media Release, 9 July 2026
Axelios 1 sequencing platform	Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future. More information: Media Release, 29 June 2026
Ventana PTEN (SP218) RxDx Assay	Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes. More information: Media Release, 12 June 2026
Liver Disease Panel	Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer. More information: Media Release, 27 May 2026
Elecsys pTau217 test	Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world. More information: Media Release, 12 May 2026
PathAI agreement	Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients. More information: Media Release, 7 May 2026

Diagnostics sales

Sales	CHF millions		As % of sales		% change
January–June	2026	2025	2026	2025	At CER	In CHF
Diagnostics Division	6,735	6,959	100.0	100.0	3	-3
Customer areas
Core Lab	3,756	3,839	55.8	55.2	4	-2
Molecular Lab	1,196	1,250	17.7	18.0	3	-4
Near Patient Care	909	1,018	13.5	14.6	-5	-11
Pathology Lab	874	852	13.0	12.2	11	3
Regions
Europe, Middle East, Africa	2,466	2,485	36.6	35.7	3	-1
North America	2,211	2,235	32.8	32.1	8	-1
Asia-Pacific	1,522	1,729	22.6	24.9	-5	-12
Latin America	536	510	8.0	7.3	10	5

More information on Roche’s performance in the first six months of 2026:

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025.
[2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies.
[3] Products launched before 2015.

Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

Roche Global Media Relations
Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com

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Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 32 17
E-mail: kalm.loren@gene.com

Attachments

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s strong momentum continues in the first half of 2026, delivering +6% sales growth at constant exchange rates; -2% in CHF due to the significant appreciation of the Swiss franc

Thu, 23 Jul 2026 05:00:00 GMT

Group sales were +6% at constant exchange rates (CER)¹, -2% when reported in CHF and +8% in USD², in the first six months, driven by high demand for innovative medicines and diagnostics.
Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers.
Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions.
Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc.
Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc.
Highlights:
- US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys
- US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus
- Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II)
- Launch of Axelios 1, a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale
- EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection
- US approval for Ventana PTEN (SP218) RxDx Assay, the first companion diagnostic to assess the levels of a key protein in prostate cancer
- Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology
- Agreement to acquire PathAI to transform AI-driven diagnostics
Outlook for 2026 confirmed.

Outlook for 2026

Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.

Key figures	CHF millions		% change
January–June	2026	2025	At CER¹	In CHF	In USD
Group sales	30,364	30,944	6	-2	8
Pharmaceuticals Division	23,629	23,985	6	-1	8
Diagnostics Division	6,735	6,959	3	-3	6
Core operating profit	11,856	12,010	10	-1
Core EPS – diluted (CHF)	10.85	11.08	9	-2
IFRS operating profit	9,671	10,330	6	-6

Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.”

Group results

In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates.

Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF).

IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc.

Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth.

In North America, sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas.

In Latin America, sales were +10% at CER, or +5% when reported in CHF.

Pharmaceuticals: key developments

Compound	Milestone
Regulatory
Gazyva/Gazyvaro Several autoimmune diseases	FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years.
Enspryng Thyroid eye disease	FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated.
Lunsumio and Polivy Blood cancer	FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment.
Tecentriq Colon cancer	FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery.
Giredestrant Breast cancer	FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026.
Phase III, pivotal and other key read-outs
Divarasib Lung cancer	Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population.
Fenebrutinib Multiple sclerosis	Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS).
Other
Alzheimer’s integrated portfolio presentation	Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care.
Nurix Therapeutics collaboration	Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors.
Obesity portfolio data presentation	Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option.
Oncology portfolio data presentation	Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers.
Ophthalmology portfolio data presentation	Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions.

Pharmaceuticals sales

Sales	CHF millions		As % of sales		% change
January–June	2026	2025	2026	2025	At CER	In CHF
Pharmaceuticals Division	23,629	23,985	100.0	100.0	6	-1
United States	12,229	12,670	51.8	52.8	6	-3
Europe	4,520	4,566	19.1	19.0	1	-1
Japan	1,360	1,425	5.8	5.9	11	-5
International	5,520	5,324	23.3	22.3	10	4

International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Top 20 best-selling pharmaceuticals	Total		United States		Europe		Japan		International
Top 20 best-selling pharmaceuticals	CHF m	%	CHF m	%	CHF m	%	CHF m	%	CHF m	%
Ocrevus Multiple sclerosis	3,470	7	2,300	2	758	10	-	-	412	30
Hemlibra Haemophilia A	2,492	11	1,313	9	502	4	171	9	506	26
Vabysmo Eye diseases (nAMD, DME, RVO)	2,059	8	1,333	1	386	5	75	26	265	65
Tecentriq Cancer immunotherapy	1,704	6	815	9	410	-3	146	-2	333	17
Xolair³ Chronic hives, food allergies	1,673	27	1,673	27	-	-	-	-	-	-
Perjeta³ Breast cancer	1,389	-7	551	-11	238	-14	24	-23	576	0
Phesgo Breast cancer	1,318	18	318	0	425	9	88	15	487	47
Actemra/RoActemra³ RA, COVID-19	1,074	-9	515	-9	238	-21	140	8	181	-3
Evrysdi Spinal muscular atrophy	968	17	323	15	335	17	39	-1	271	25
Kadcyla³ Breast cancer	916	-6	310	-14	248	-4	39	2	319	3
Polivy Blood cancer	808	20	381	28	128	-18	98	16	201	47
Alecensa Lung cancer	795	6	261	4	126	-4	93	8	315	13
MabThera/Rituxan³ Blood cancer, RA	609	5	402	14	62	-9	6	-11	139	-10
Activase/TNKase³ Cardiac diseases	555	11	531	11	-	-	-	-	24	12
Gazyva/Gazyvaro³ Blood cancer, lupus nephritis	489	7	240	4	117	-1	17	14	115	21
Herceptin³ Breast and gastric cancer	462	-12	94	-14	136	-7	2	-36	230	-14
Avastin³ Various cancer types	414	-15	125	-12	35	37	36	-44	218	-13
Pulmozyme³ Cystic fibrosis	204	-8	145	-5	29	-11	-	26	30	-18
Columvi Blood cancer	196	70	91	28	53	116	-	-	52	173
Enspryng Acute inflammation of brain, spinal cord and optic nerves	195	22	50	20	23	20	79	18	43	37

DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis

Diagnostics: key developments

Product	Milestone
cobas HDV test	Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available.
Elecsys IGRA TB test	Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient.
Axelios 1 sequencing platform	Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future.
Ventana PTEN (SP218) RxDx Assay	Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes.
Liver Disease Panel	Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer.
Elecsys pTau217 test	Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world.
PathAI agreement	Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients.

Diagnostics sales

Sales	CHF millions		As % of sales		% change
January–June	2026	2025	2026	2025	At CER	In CHF
Diagnostics Division	6,735	6,959	100.0	100.0	3	-3
Customer areas
Core Lab	3,756	3,839	55.8	55.2	4	-2
Molecular Lab	1,196	1,250	17.7	18.0	3	-4
Near Patient Care	909	1,018	13.5	14.6	-5	-11
Pathology Lab	874	852	13.0	12.2	11	3
Regions
Europe, Middle East, Africa	2,466	2,485	36.6	35.7	3	-1
North America	2,211	2,235	32.8	32.1	8	-1
Asia-Pacific	1,522	1,729	22.6	24.9	-5	-12
Latin America	536	510	8.0	7.3	10	5

Roche’s Half-Year Results 2026 Webinar
There will be a live webinar for investors and analysts today, Thursday, 23 July at 14:00 CEST. To access the webinar, please click here.

Additional information
Half-Year 2026 Presentation: http://www.roche.com/irp260723-a.pdf
Half-Year 2026 Presentation with appendix: http://www.roche.com/irp260723.pdf
Half-Year Report 2026: http://www.roche.com/hy26e.pdf
Group Pharmaceuticals pipeline: http://www.roche.com/pharmahy26.pdf
Group Diagnostics pipeline: http://www.roche.com/diahy26.pdf

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceuticals Divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025.
[2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies.
[3] Products launched before 2015.

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 32 17
E-mail: kalm.loren@gene.com

Attachment

260723_IR_HY_roche-2026_en

Reminder: Invitation to Roche’s Half Year Results 2026 Presentation

Thu, 16 Jul 2026 08:00:00 GMT

Roche will publish its Half Year Results of 2026 prior to the opening of the Swiss Stock Exchange on Thursday, 23 July 2026. 07:00 CEST / 06:00 BST / 01:00 AM EDT / 10:00 PM PDT (evening before) Release will be e-mailed and posted on the Roche IR website > click here Presentation slides will be posted on the Roche IR website > click here 14:00 – 15:45 CEST / 13:00 – 14:45 BST 08:00 – 09:45 AM EDT / 05:00 - 06:45 AM PDT The webinar will start with presentations by senior management, followed by a Q&A session. Presenters: Thomas Schinecker, CEO Roche Group Alan Hippe, Chief Financial Officer Roche Teresa Graham, CEO Roche Pharmaceuticals Matt Sause, CEO Roche Diagnostics We would like to invite all interested parties to participate in the webinar and to pre-register for the event here.* Should you be unable to register for the webinar due to your company IT policy, please send an e-mail to investor.relations@roche.com. A replay of the webcast will be available via > ir.roche.com *privacy notice Best regards,
Bruno Eschli Head of Investor Relations
Roche Investor Relations
Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America
Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com

FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy

Wed, 15 Jul 2026 05:00:00 GMT

Priority Review decision is based on phase III MAJESTY results, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus¹
If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for primary membranous nephropathy (pMN), following global approvals in lupus nephritis and ongoing regulatory filings in lupus and idiopathic nephrotic syndrome
pMN is a chronic autoimmune disease with no FDA or EMA approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over 10 years^2,3

Basel, 15 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has granted Priority Review to the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of primary membranous nephropathy (pMN). The priority review is based on the positive phase III MAJESTY results, which show superiority of Gazyva/Gazyvaro over an immunosuppressive therapy, tacrolimus, in adults with pMN.¹ The FDA has already granted Breakthrough Therapy Designation (BTD) to Gazyva/Gazyvaro in pMN and is expected to make a decision on approval by November 2026. This is the second indication in recent months for which the US FDA has granted priority review to Gazyva/Gazyvaro, following idiopathic nephrotic syndrome in
May 2026.

“This priority review represents an important step for patients living with primary membranous nephropathy, a chronic disease with no FDA-approved treatments," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “By targeting tissue-resident B cells, Gazyva/Gazyvaro addresses an underlying cause of pMN and has the potential to help more patients achieve complete remission - a necessary step to maintaining kidney function.”

The phase III MAJESTY study met its primary endpoint, with 36.9% of adults achieving complete remission (CR) at two years (104 weeks) with Gazyva/Gazyvaro versus 5.7% with tacrolimus (adjusted difference 31.1%; 95% confidence interval [CI] 18.2 to 44.0; p<0.001). Complete remission is the ultimate goal in pMN and can help prevent progression to kidney failure. Key secondary endpoints showed that Gazyva/Gazyvaro was superior to tacrolimus in achieving overall remission (complete or partial remission) at week 104 and complete remission at week 76. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro and no new safety signals were identified.

The data were featured at the 63^rd European Renal Association (ERA) Congress in June 2026 as a late-breaking oral presentation and published in the New England Journal of Medicine (NEJM).¹ In April 2026, the FDA granted Breakthrough Therapy Designation for Gazyva/Gazyvaro in pMN.

Data from MAJESTY are also being submitted to other global health authorities, including the European Medicines Agency.

pMN is a chronic autoimmune condition that causes potentially irreversible kidney damage and can lead to kidney failure, which has a significant impact on patients and their families, while carrying substantial burden to health systems.^2,3 Achieving complete remission is important to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.³

MAJESTY is the fourth positive phase III study of Gazyva/Gazyvaro in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus (SLE) and INShore in idiopathic nephrotic syndrome – where it also received priority review and Breakthrough Therapy Designation by the FDA.^4,5,6 Gazyva/Gazyvaro is approved in the US and EU for the treatment of adults with active lupus nephritis who are receiving standard therapy based on data from the REGENCY and NOBILITY studies,^4,7 and is being investigated in the phase II POSTERITY study for children and adolescents with lupus nephritis.⁸ This growing body of evidence supports Gazyva/Gazyvaro's potential in addressing disease activity across a spectrum of immune-mediated diseases.

Beyond Gazyva/Gazyvaro, we have a broad pipeline to bring breakthrough innovation across immunology, including immune-mediated kidney diseases. This includes Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell-engaging bispecific antibody being investigated in SLE.⁹

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death, and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC).¹⁰ CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is approved for adults with lupus nephritis in the US and the EU. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

About the MAJESTY study
MAJESTY [NCT04629248] is a phase III, randomised, open-label, multicentre study designed to evaluate the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) in adults with primary membranous nephropathy. The study enrolled 142 adults who were randomised 1:1 to receive Gazyva/Gazyvaro or tacrolimus. The primary endpoint is the percentage of adults who achieve complete remission at two years (week 104).

About primary membranous nephropathy
Primary membranous nephropathy is a chronic autoimmune condition where the body’s immune system attacks the filtering units of the kidney, the glomeruli, causing protein to leak into the urine and potentially a gradual decline in kidney function. Over time, the damage to the kidneys can become irreversible, increasing the risk of life-threatening complications, such as kidney failure, idiopathic nephrotic syndrome, blood clots and cardiovascular diseases. Achieving complete remission is important to help maintain kidney function and delay or prevent the onset of serious and potentially fatal complications.

Primary membranous nephropathy has an estimated incidence of 1.2 per 100,000 people in the United States per year.¹¹

About Roche in Immunology
For over two decades, Roche has advanced immune system research, creating groundbreaking targeted treatments that have transformed care for people with blood disorders, neurological conditions and autoimmune diseases. With a development pipeline exploring more than 20 medical approaches, we are targeting widespread, complex conditions like chronic lung disease (COPD) and inflammatory bowel disease (IBD), alongside lupus, autoimmune kidney diseases and severe skin conditions (atopic dermatitis). Our ultimate goal is to lessen the burden of chronic immune disorders on patients, healthcare systems, and society.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Fercenza FC, et al. Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy. NEJM. [Internet; cited 2026 July]. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2602678.
[2] Keri KC, et al. Primary membranous nephropathy: comprehensive review and historical perspective. Postgrad Med L. 2019 Jan;95(1119). doi: 10.1136/postgradmedj-2018-135729.
[3] Kanigicherla DAK, et al. Long-term outcomes of persistent disease and relapse in primary membranous nephropathy. Nephrol Dial Transplant. 2016 Dec:31(12):2108-2114. doi: 10.1093/ndt/gfv435. Epub 2016 Jan 13.
[4] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83. [Internet; cited 2026 July]. Available from: https://pubmed.ncbi.nlm.nih.gov/39927615/
[5] Furie RA, et al. Efficacy and Safety of Obinutuzumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2026 March.
[6] Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome (INShore). [Internet; cited 2026 July]. Available from: https://clinicaltrials.gov/study/NCT05627557
[7] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07. [Internet; cited 2026 July]. Available from: https://pubmed.ncbi.nlm.nih.gov/34615636/
[8] Clinicaltrials.gov. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants (POSTERITY) [Internet; cited 2026 July]. Available from: https://clinicaltrials.gov/study/NCT05039619
[9] Clinicaltrials.gov. A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis (SOLUNA). [Internet; cited 2026 July]. Available at: https://clinicaltrials.gov/study/NCT07598396
[10] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[11] Alok A, Yadav A. Membranous Nephropathy. [Updated 2023 Jun 5]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan. [Cited 2026 July]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK559169.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Roche Media Investor Release Stage 3 Gazyva pMN Priority Review sBLA acceptance English

Roche introduces cobas Hepatitis D Virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis

Tue, 14 Jul 2026 05:00:00 GMT

The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response.
Hepatitis D affects nearly 12 million of people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types.
The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available.

Basel, 14 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it introduces the cobas® HDV test for use on the cobas® 5800/6800/8800 systems, a diagnostic tool for the detection and quantification of Hepatitis D Virus (HDV) RNA, in countries accepting the CE mark. Available on the industry-leading cobas 5800/6800/8800 systems, Roche aims to help healthcare providers in identifying patients and monitoring their care more effectively alongside newly available treatments.

"This is an important advancement of our commitment to improving outcomes for people living with liver disease," said Matt Sause, CEO of Roche Diagnostics. "With the cobas HDV test, we are providing clinicians with a reliable tool to aid in the identification of infected individuals and to monitor their response to treatment."

Hepatitis D, which globally affects an estimated 12 million people¹, is a unique ‘satellite virus’ that can only infect people who already have the Hepatitis B virus (HBV). Because of this relationship, it can occur as a co-infection, that is, being infected with both viruses at once, or a super-infection, which is being infected with HDV after already having chronic Hepatitis B. Co-infection could explain about 1 in 5 cases of liver disease², and super-infection being particularly dangerous with over 90% of cases becoming chronic and accelerating to liver damage³.

Despite the severity of the disease, testing has often been limited to manual methods or lab-developed tests that can vary in consistency. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market and addresses the urgent need for a consistent, widely accessible solution. This is particularly important now that specific treatments for HDV are becoming available in many markets, requiring precise monitoring to ensure they are working and to advance patient care.

The assay runs on the fully automated cobas® 5800/6800/8800 systems. These fully automated platforms are already used in laboratories worldwide, allowing for seamless integration into existing workflows. By automating the testing process, laboratories can deliver accurate results faster and more efficiently, helping clinicians make timely decisions for their patients.

About Hepatitis D
Hepatitis D leads to faster progression toward liver failure, cirrhosis, and liver cancer compared to other forms of hepatitis. Symptoms can be severe and include jaundice (yellowing of the skin and eyes), extreme fatigue, abdominal pain, and nausea. The virus is transmitted through contact with infected blood or bodily fluids. Because it requires Hepatitis B to replicate, vaccination against Hepatitis B is the most effective way to prevent Hepatitis D infection.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] World Health Organization factsheet on Hepatitis D, July 2025. https://www.who.int/news-room/fact-sheets/detail/hepatitis-d
[2] The global prevalence of hepatitis D virus infection: Systematic review and meta-analysis. Stockdale, Alexander J. et al. Journal of Hepatology, Volume 73, Issue 3, 523 - 532
[3] Bardak AE, Ozturk NB, Gurakar M, Sequeira L, Yildiz E, Ozmert EH, Idilman R, Gurakar A. Updates on Recent Advancements in Hepatitis D Virus Treatment. Viruses. 2025 Aug 10;17(8):1100. doi: 10.3390/v17081100. PMID: 40872814; PMCID: PMC12390690.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Investor Release cobas HDV CE Mark English

Roche receives CE Mark for blood test to identify tuberculosis infection

Thu, 09 Jul 2026 15:21:18 GMT

The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress toward the World Health Organization's elimination targets.
Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions.
The new solution provides rapid, high-throughput, and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient.

Basel, 9 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that its Elecsys IGRA TB test has received the CE Mark, introducing a new blood testing solution for identifying tuberculosis infection (TBI, also known as latent TB) in routine laboratory settings. The new solution enables fast, simple, and efficient diagnosis, and can provide results in under 24 hours. The Interferon Gamma Release Assay (IGRA) itself takes just 19 minutes per patient to process, which is approximately half the time of currently used methods. Laboratories now have an option for IGRA testing, with faster turnaround and scalable throughput on Roche’s systems.

“Addressing latent tuberculosis is critical to reducing the global health burden of this devastating disease, and that begins with better, more accessible testing,” said Matt Sause, CEO of Roche Diagnostics. “The Elecsys IGRA TB test brings an automated solution for latent TB to Roche’s industry-leading immunoassay platforms, which will enable screening programs and drive significant progress toward achieving global TB elimination targets.”

Tuberculosis remains one of the world’s most significant public health challenges, with an estimated 10.7 million people falling ill and 1.23 million losing their lives to the disease in 2024 alone.¹ It is estimated that approximately a quarter of the global population may have been infected with the bacteria that cause tuberculosis.² While the infection can lie dormant without causing symptoms, 5 to 10% of cases will progress to symptomatic disease during a person’s lifetime.³ Diagnosis of tuberculosis infection is essential to breaking the cycle of disease progression and transmission, preventing severe health complications, and guiding decisions about preventive treatment in high-risk populations. Expanding access to reliable diagnostics remains critical to achieving the World Health Organization’s (WHO) global elimination targets, which aim to decrease tuberculosis deaths by 90% and new cases by 80% by 2030.⁴
Blood-based IGRA tests and tuberculin skin tests are established methods for identifying tuberculosis infections. In addition to offering higher accuracy and reliability, IGRAs provide a less invasive alternative to skin tests, requiring only a single patient visit and reducing dependency on specialised healthcare staff. Unlike tuberculin skin tests, IGRAs show minimal interference from Bacillus Calmette-Guérin (BCG) vaccinations, which remain widely used worldwide.⁵

Traditional IGRA testing often involves labour-intensive workflows and manual procedures that significantly burden laboratory resources. These demanding processes not only increase the risk of errors, but also create barriers for laboratories attempting to implement more reliable blood-based testing methods or scale their operations to meet the rising demand for tuberculosis infection diagnostics.

By pairing Roche’s new Elecsys IGRA TB test with existing molecular cobas MTB and cobas MTB-RIF/INH assays, laboratories gain an integrated solution for managing both tuberculosis infection and active disease. The Elecsys IGRA TB assay will also feature a novel digital tool to fully automate result calculation, interpretation and reporting. This ensures rapid, reliable, and fully traceable results while freeing up valuable laboratory resources. To further reduce manual laboratory workloads, the Elecsys IGRA TB assay is designed to integrate seamlessly with third-party automated liquid handlers for front-end processes prior to tube incubation. Additionally, Roche’s long-term automation roadmap includes plans to introduce fully integrated, proprietary front-end automation. This will allow laboratories to optimize their workflows now while preparing for complete, end-to-end operational efficiency in the future.

Clinical data
The performance of Elecsys IGRA TB was evaluated in a global, multi-centre study conducted at both low-incidence and high-incidence settings in the European, Western Pacific, African regions and regions of the Americas. In the intended use population, i.e. individuals currently requiring tuberculosis infection testing as part of their clinical care, Elecsys IGRA TB achieved 91.12% positive percent agreement (PPA) and 94.57% negative percent agreement (NPA) when compared to standard of care methods. In bacteriologically confirmed TB disease patients, Elecsys IGRA TB demonstrated a relative sensitivity of 100% compared to an established IGRA method. Furthermore, in accordance with established clinical trial protocols, the specificity of Elecys IGRA TB was estimated in a low-risk cohort and demonstrated a specificity of 95.32 %⁶. These results together demonstrate a highly reliable performance.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] WHO Global Tuberculosis Report 2025, available at URL: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/tb-reports/global-tuberculosis-report-2025
[2] Houben RM, Dodd PJ. The Global Burden of Latent Tuberculosis Infection: A Re-estimation Using Mathematical Modelling. PLoS Med. 2016 Oct 25;1
[3](10):e1002152. doi: 10.1371/journal.pmed.1002152. PMID: 27780211; PMCID: PMC5079585.[3] WHO Latent tuberculosis infection: updated and consolidated guidelines for programmatic management 2018, available at URL: https://www.who.int/publications/i/item/9789241550239
[4] World Health Organization, End TB Strategy. Available at URL: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/the-end-tb-strategy
[5] BCG World Atlas, available at URL: http://www.bcgatlas.org/
[6] Elecsys IGRA TB Method Sheet 2026-04 V1.0

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Release IGRA TB CE Mark

Roche presents new data in Alzheimer’s disease from across its integrated pharmaceutical and diagnostics portfolio at AAIC

Tue, 07 Jul 2026 05:00:00 GMT

Five oral presentations in a Featured Research Session will highlight trontinemab, including new long-term data from Phase Ib/IIa Brainshuttle^TM AD study and design of Phase III PrevenTRON study in preclinical Alzheimer’s
New data on Roche’s CE mark Elecsys pTau217 blood test will be presented on its use for Alzheimer's diagnosis in both primary and secondary care

Basel, 7 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it will present new data from its Alzheimer’s disease portfolio at the Alzheimer’s Association International Conference^® 2026 (AAIC^®) in London on 12-15 July. These data demonstrate how Roche is advancing the development of next-generation medicines and diagnostic tests, driven by a mission to slow, stop or even prevent the progression of Alzheimer’s disease. In total, there are 18 oral and poster presentations. Highlights include five oral presentations as part of a trontinemab Featured Research Session, an oral Perspectives Session on neuroimmune targets such as NLRP3 for neurodegenerative diseases, and presentations on the use of Roche's Elecsys^® pTau217 and pTau181 blood tests to support Alzheimer’s disease diagnosis.

“We aim to bring together advanced diagnostics and transformative medicines, with the goal of benefitting many Alzheimer's patients through earlier detection and intervention,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our presentations at AAIC will feature data from our expanding Alzheimer’s disease portfolio, including investigational trontinemab, neuroinflammatory approaches and blood-based diagnostics.”

“With the approval of Elecsys pTau217, our third Alzheimer’s blood test, across both primary and secondary care, we are making timely and definitive diagnosis more accessible than ever before,” said Matt Sause, CEO of Roche Diagnostics." For too long, this has been out of reach for the vast majority of patients. As a result, millions have been left without the answers, care and support they need. That is now changing, as blood-based testing transforms the diagnosis of Alzheimer’s disease."

Pharmaceuticals
Trontinemab Featured Research Session
A 90-minute Featured Research Session will showcase five oral presentations focused on the latest progress in the development of trontinemab, an investigational Brainshuttle^TM bispecific 2+1 amyloid-beta targeting monoclonal antibody. Presenters will share new long-term safety, amyloid removal and biomarker data from the Phase Ib/IIa Brainshuttle AD open-label extension study. Modelling from this study has informed the dosing regimen for the ongoing Phase III TRONTIER 1 and 2 studies in early symptomatic Alzheimer’s disease.

For the first time, Roche will also share the design of PrevenTRON, a Phase III study investigating trontinemab in preclinical Alzheimer’s disease. PrevenTRON is planning to recruit cognitively unimpaired individuals at high risk of progression to symptomatic Alzheimer’s, and investigators are using Roche’s Elecsys pTau217 blood test to help identify potential study participants.

NLRP3 inhibition Invited Perspectives Session
In addition to targeting amyloid with trontinemab, Roche is exploring multiple other investigational therapeutic approaches to tackle the complexity of neurodegenerative diseases. AAIC has invited Roche to present a Perspectives Session on the NLRP3 inflammasome in Alzheimer’s disease. Emerging preclinical and clinical data on the immunomodulatory effects of NLRP3 inhibition in neurodegenerative disorders such as Alzheimer’s and Parkinson’s disease will also be presented.

Diagnostics
Roche’s Elecsys pTau217 blood test recently received CE mark certification as both a rule-in and rule-out test of amyloid pathology to aid in Alzheimer’s disease diagnosis, and data will be presented evaluating the test’s performance in primary and secondary care settings. In addition, new data will be presented for the approved Elecsys pTau181 blood test for ruling out Alzheimer’s disease, which explores sample stability under different storage conditions and test performance across large, diverse, cognitively impaired patient populations to support implementation of the test in routine clinical practice.

Roche is sponsoring a symposium “Closing the Diagnostic Gap: Utilizing pTau217 for Scalable Alzheimer’s Disease Diagnosis” on Sunday 12 July at 12:30-13:45 BST at the Crowne Plaza London Docklands Hotel. The symposium will discuss the evolving role of blood-based biomarkers in the early detection and diagnosis of Alzheimer’s disease, including the potential of scalable blood testing approaches designed to help reduce diagnostic barriers, enable earlier identification of individuals at risk, and support broader access to disease-modifying therapies in clinical practice.

Overview of key presentations featuring Roche pharmaceuticals and diagnostics:

Topic	Abstract title	Presentation number (type) Presentation date (session) Time Location
Abstracts will be available on the AAIC website.
Trontinemab	Long-Term Safety and Amyloid Removal with Trontinemab: Interim Data from the Open-Label Extension of the Phase Ib/IIa Brainshuttle™ AD Study	3-21-FRS-B (5 Orals) Tuesday 14 July (Featured Research Session: Shuttling Past the Barrier: From Brainshuttle^TM AD Long-Term Trontinemab Data to Secondary Prevention of AD in PrevenTRON) 14:00–15:30 BST Room S8
	Interim Long-Term Biomarker Results from the Trontinemab Open-Label Extension of the Phase Ib/IIa Brainshuttle™ AD Study
	Simulation of Amyloid Clearance in Phase III Studies with Trontinemab in Early Symptomatic Alzheimer’s Disease
	Evidence Supporting Preclinical AD as an Optimal Stage for Intervention with Trontinemab
	PrevenTRON: Rationale and Design of a Phase III Trial of Trontinemab in Cognitively Unimpaired Individuals with Biomarkers of Alzheimer’s Disease at High Risk of Clinical Decline
NLRP3	The Role of NLRP3 in Alzheimer's Disease: Reverse Translational Data from GRADUATE Ph3 Trials	3-25-PER-C (Oral invited talk) Tuesday 14 July (Perspectives Session: Neuroimmune Targets for Neurodegenerative Diseases) 14:00-15:30 BST Room N11A
NLRP3	Investigating the Role of the NLRP3 Inflammasome in the Pathogenesis of Alzheimer’s Disease	#0274 (Poster) Tuesday 14 July (Basic Science and Pathogenesis: Molecular and Cell Biology) 7:30–16:15 BST Exhibit Hall
Clinical Insights	External Controls Vs. Observed Placebo: How Close Can We Get? GRADUATE I and II Results	2-15-FRS-A (Oral) Monday 13 July (Featured Research Session: External Controls in Alzheimer’s Clinical Trials: How Far Away Are We?) 9:00–10:30 BST Room N10
Clinical Insights	Tau Pathology Interferes with Amyloid Removal by Gantenerumab	4-29-FRS-A (Oral) Wednesday 15 July (Featured Research Session: Next-Generation Neuroimaging: Monitoring Treatments and Disease Progression) 14:00-15:30 BST Room Victoria 5/6
Patients living with Alzheimer’s and their caregivers	Burden and Support Needs of Informal Caregivers of People Living with Alzheimer’s Disease in Three Countries	#0974 (Poster) Tuesday 14 July (Dementia Care Research and Psychosocial Factors: Psychosocial and Behavioral Factors) 7:30–16:15 BST Exhibit Hall
Patients living with Alzheimer’s and their caregivers	Mental Health Conditions in Spouses of People Living with Alzheimer's Disease: A Longitudinal US Claims Data Analysis	#0988 (Poster) Wednesday 15 July (Dementia Care Research and Psychosocial Factors: Psychosocial and Behavioral Factors) 7:30–16:15 BST Exhibit Hall
Clinical trial excellence	Expanding Clinical Trial Access to Underrepresented Populations in the U.S.: Findings from the Alzheimer’s Disease Pre-Screener Study	#0174 (Poster) Sunday 12 July (Drug Development: Human) 7:30–16:15 BST Exhibit Hall
Clinical trial excellence	A Low-Burden Cognitive Prescreening Protocol for Enhanced Diversity and Recruitment in Roche’s Alzheimer’s Disease Clinical Trials	#0038 (Poster) Wednesday 15 July (Drug Development: Human) 7:30–16:15 BST Exhibit Hall
Diagnostics	Rule-Out Performance of a Plasma pTau181 Immunoassay at Established Cutoffs in Subgroups Across a Large, Diverse, Cognitively Impaired Population	4-29-FRS-A (Oral) Wednesday 15 July (Featured Research Session: Next-Generation Neuroimaging: Monitoring Treatments and Disease Progression) 14:00–15:30 BST Room Victoria 5/6
	Evaluating a Future In Vitro Diagnostic pTau217 Plasma Assay for the Detection of Amyloid Pathology in Primary and Secondary Care Settings	#1076 (Poster) Sunday 12 July (Developing Topics: Biomarkers) 7:30–16:15 BST Exhibit Hall
	Elecsys pTau181 Plasma Immunoassay Performance Against Centiloid-Based Amyloid Classification Across Clinical Stages	#1071 (Poster) Sunday 12 July (Developing Topics: Biomarkers) 7:30–16:15 BST Exhibit Hall
	Elecsys Cerebrospinal Fluid Biomarker Ratio Concordance with Amyloid-Positron Emission Tomography in a Chinese Population	#1070 (Poster) Sunday 12 July (Developing Topics: Biomarkers) 7:30–16:15 BST Exhibit Hall
	Sample Stability for a New pTau181 Plasma Immunoassay: Implications for Rule-Out Testing for Alzheimer’s Disease in Routine Clinical Practice	#0476 (Poster) Wednesday 15 July (Biomarkers: Biomarkers (Non-Neuroimaging)) 7:30–16:15 BST Exhibit Hall

About Roche in Alzheimer’s
With more than two decades of scientific research in Alzheimer’s disease, Roche is working towards a day when we can detect, diagnose, monitor and treat the condition earlier, so we can slow, stop or even prevent its progression.

Today, Roche’s Alzheimer’s disease portfolio spans several investigational medicines for different targets, types and stages of the disease, including trontinemab, nivegacetor and RG6627. On the diagnostics side, it covers approved and investigational digital and blood-based tests and cerebrospinal fluid (CSF) assays, including Elecsys pTau181, pTau217 and ApoE4.

Addressing the global burden of Alzheimer’s disease requires more than innovative tests and treatments. This is why Roche partners with clinicians, scientists, patient advocates, policymakers and health systems to help ensure that advances in Alzheimer’s disease research translate into benefits for millions of people worldwide.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

AAIC 2026 Curtain Raiser Media Investor Release English

[Ad hoc announcement pursuant to Art. 53 LR] Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer

Thu, 02 Jul 2026 05:00:00 GMT

Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer
Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed
Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population
Data will be submitted to health authorities and presented at an upcoming medical meeting

Basel, 02 July 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today positive results from the phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). The safety profile for divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible.

“The superior survival demonstrated in this global head-to-head comparison of KRAS G12C inhibitors confirms the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “These results should establish divarasib as a new standard of care for previously-treated lung cancer patients with this genetically defined tumor subtype.”

Efficacious treatments for KRAS G12C NSCLC represent a significant unmet need in lung cancer care. The G12C mutation is one of the most common KRAS oncogene mutations, found in approximately 14% of NSCLC cases and associated with poor prognosis for patients.^1,2

Roche is advancing a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C non-small cell lung cancer (NSCLC).

Data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible.

About Krascendo 1
The Krascendo 1 study [NCT06497556] is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first generation KRAS G12C inhibitors.³ This phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of divarasib monotherapy versus sotorasib or adagrasib in people with previously treated KRAS G12C-mutant advanced or metastatic non-small cell lung cancer.³ The study includes 338 adults, randomised to receive either divarasib (once daily) or, either sotorasib (once daily) or adagrasib (twice daily).³ The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival.³ Secondary endpoint measures include overall survival, confirmed objective response, duration of response, as well as other efficacy and safety measures.³

About divarasib
Divarasib is an investigational, next-generation, oral, KRAS G12C inhibitor. It has shown greater potency and selectivity in preclinical studies compared with first generation KRAS G12C-targeting treatments, sotorasib and adagrasib.^4,5 Divarasib is designed to selectively bind to the KRAS G12C protein, locking the protein in an inactive (‘off’) state, thereby turning off its tumour-driving signalling.⁶

Divarasib’s comprehensive clinical development programme is anchored by three phase III studies:

Study	Intervention	Patient population
Krascendo 1 [NCT06497556]	Divarasib monotherapy vs sotorasib or adagrasib	Previously treated KRAS G12C-mutant advanced or metastatic NSCLC (second-line)
Krascendo 2 [NCT06793215]	Divarasib plus pembrolizumab (chemotherapy-free combination) vs chemotherapy plus pembrolizumab	Previously untreated KRAS G12C-mutant advanced NSCLC (first-line)
Krascendo 3 [NCT07541170]	Adjuvant divarasib monotherapy vs immunotherapy or observation	Resected stage II–IIIB KRAS G12C-mutant NSCLC after standard of care chemoimmunotherapy (early-stage)

About KRAS G12C non-small cell lung cancer
Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers.^7,8 Each year, it claims the lives of 1.8 million people, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases.^7,9 KRAS is one of the most frequently mutated genes in lung cancer, occurring in approximately 25% of newly diagnosed lung cancers.¹⁰ The G12C mutation is one of the most common KRAS mutations, found in approximately 14% of NSCLC cases.¹

The KRAS gene produces the KRAS protein, which acts as a cellular control switch, cycling between an active ('on') and inactive ('off') state to regulate cell growth and proliferation, making it a critical target for new therapeutic strategies.¹⁰ The G12C mutation locks the KRAS protein in its active ('on') state, leading to continuous, unregulated signalling for cell growth, driving tumour proliferation.^6,10

About Roche in lung cancer
Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of deep scientific expertise to improve patient outcomes and their overall experience. Roche’s strong commitment to investment in research and development has built a robust portfolio of approved medicines and companion diagnostics, which empowers physicians to better understand a patient's disease and optimise care.

Roche’s broad portfolio includes approved medicines such as Alecensa® (alectinib), Tecentriq® (atezolizumab), and Rozlytrek® (entrectinib). Its extensive pipeline includes investigational treatments across three key focus areas: small cell lung cancer, non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGA), and NSCLC without AGA. Utilising diverse approaches, ranging from cancer-cell-killing ‘cytotoxics’ and immunotherapies to treatments targeting specific characteristics of cancer cells, we aim to translate scientific discoveries into meaningful progress in patient care.

All trademarks used or mentioned in this release are protected by law.

References
[1] Nassar AH, et al. Distribution of KRAS (G12C) Somatic Mutations across Race, Sex, and Cancer Type. N Engl J Med 2021; 384 (2): 185-187.
[2] Wankhede, Durgesh, et al. Prognostic role of KRAS G12C mutation in non-small cell lung cancer: a systematic review and meta-analysis. Diagnostics 13.19 (2023): 3043.
[3] Gadgeel S, et al. P3.12D.07 Divarasib Versus Adagrasib or Sotorasib in Pretreated KRAS G12C+ Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC). J of Thorac Oncol. 2024; 19 (10, Supplement): S349.
[4] Endres NF, et al. Discovery and Characterization of Divarasib (GDC-6036), a Potent Covalent Inhibitor of KRAS G12C. J Med Chem 2026; 69 (5): 5147-5165.
[5] Landry ML, et al. Discovery and Optimization of a Potent, Efficacious, and Brain-Penetrant Inhibitor of KRAS G12C. J Med Chem 2026; 69 (5): 5241-5258.
[6] Friedlaender A, et al. KRAS as a druggable target in NSCLC: rising like a phoenix after decades of development failures. Cancer Treat Rev. 2020;85:101978.
[7] World Health Organization. Global cancer burden growing, amidst mounting need for services [Internet; cited 2026 June]. Available from: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services.
[8] American Lung Association. Lung Cancer Statistics [Internet; cited 2026 June]. Available from: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet.
[9] World Health Organization. Lung cancer [Internet; cited 2026 June]. Available from: https://www.who.int/news-room/fact-sheets/detail/lung-cancer.
[10] Pakkala S, et al. Personalized therapy for lung cancer: striking a moving target. JCI Insight 2018; 3 (15).

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phon e: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Investor Release Krascendo 1 Phase III English