Zilebesiran

Roche is in discussions with the US administration on drug pricing, but CEO Thomas Schinecker declined to say whether it might strike a deal similar to those recently cut by its peers Pfizer and AstraZeneca . Last month, Pfizer agreed to provide some of its drugs to consumers at discounts of up to 85% via a new government website dubbed TrumpRx. And earlier this month, AstraZeneca said it would offer similar concessions , with the aim of ensuring Americans pay no more for its drugs than patients in other rich countries. Schinecker made these comments during Roche’s third-quarter earnings call with the media. In the quarter, its drug sales increased by 9% to 35.6 billion Swiss francs ($44.7 billion), but the company believes the future is brighter still. It raised its full-year 2025 outlook and has pushed more drugs than ever before into late-stage trials, five of which it believes could have peak sales in excess of $3 billion. “This year, we’ve advanced 10 potentially lifesaving medicines into the last and final phase of development. This is an absolute record for us. We’ve never come close to such a number before, and we’re not even at the end of the year,” Schinecker said. Six of these new Phase 3 starts occurred in the past quarter, and several of these are in the cardiometabolic arena, where Roche has invested heavily in recent years. Two of the assets Roche obtained through its buyout of Carmot are now in late-stage trials: CT-388, for obesity and CT-868 in type 1 diabetes. Both are injected GLP-1/GIP agonists. CT-388 has posted highly promising obesity data in Phase 1, though no Phase 2 results have yet emerged. It is one of the most closely watched contenders in the obesity space. “We are taking it into a Phase 3 based on interim data,” Schinecker said. “This means that we have high confidence in our molecule.” Zilebesiran, the hypertension drug on which it is partnered with Alnylam, will also enter late-stage studies this year, despite a Phase 2 miss . And, subject to the closure of Roche’s $2.4 billion acquisition of 89bio , it will get hold of that company’s Phase 3-stage MASH therapy pegozafermin. By the end of 2030, the company expects to have no fewer than 19 new medicines on the market, 16 of which it says are potential blockbusters. Schinecker said that so far, Roche has experienced no delays at the FDA related to the US shutdown. Roche expects 2025 sales to increase in the mid-single-digit range from the Q3 figure of CHF 45.9 billion ($57.7 billion), and earnings per share are expected to grow by high single to low double digits, both on a constant currency basis. Previously, Roche had said EPS would grow by high single digits. Elsewhere in its pipeline, Roche cut several pipeline assets , including four Chugai-originated solid tumor candidates in Phase 1. Schinecker said this decision was taken simply because they were unpromising, rather than it being a deliberate strategic shift away from cancer. Despite its blistering pace of dealmaking this year — as well as the 89bio acquisition, it signed a license to Zealand Pharma’s amylin drug for up to $5.3 billion — the Swiss pharma has no intention of throttling back. “We look at everything, this is our job — to look at all the opportunities that are out there and to make a judgment,” Schinecker said. He said Roche looks at “thousands and thousands” of companies each year with a view to dealmaking, but only pulls the trigger in “less than 1%” of cases. “Going forward, you will see the same kind of behavior,” he added. Roche is not immune to the lure of China, the source of many recent transactions, not least in the metabolic space. Schinecker said that the US and China are “the most innovative places” when it comes to the discovery and development of new drugs, adding that Roche had to go where new medicines are being developed.

Basel, 23 October 2025 Group sales grew by 7%1 at constant exchange rates (CER; 2% in CHF) in the first nine months, driven by high demand for our innovative medicines and diagnostics.Pharmaceuticals Division sales rose by 9% (4% in CHF) due to continued high growth in sales of medicines for the treatment of severe diseases; Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (serious eye diseases) and Ocrevus (multiple sclerosis) were the top growth drivers.Diagnostics Division sales increased by 1% (-4% in CHF) as demand for pathology solutions and molecular diagnostics more than offset the impact of healthcare pricing reforms in China.Highlights: US approval for Tecentriq combination for a form of lung cancer and Gazyva/Gazyvaro for a severe kidney diseaseEU CE mark for Contivue, a port delivery platform with Susvimo*, for a severe eye diseasePositive EU CHMP recommendation for the subcutaneous formulation of Lunsumio for a type of blood cancer and for Gazyva/Gazyvaro for a severe kidney diseasePositive data from phase III study on giredestrant in breast cancer, phase II open-label extension study on fenebrutinib in multiple sclerosis, phase I/II study on trontinemab in Alzheimer’s disease and long-term follow-up studies on Vabysmo and Susvimo in a severe age-related eye diseaseAdvancement of several key drug candidates into phase III trials: zilebesiran for uncontrolled hypertension, CT-388 for obesity, CT-868 for type 1 diabetes, cevostamab for a difficult-to-treat form of blood cancer and ZN-1041 for a type of breast cancerAnnouncement of a merger agreement to acquire 89bio and its phase III FGF21 analogue for the treatment of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH), a form of fatty liver disease that is one of the most prevalent comorbidities of obesityEU CE mark and US approval for the Elecsys pTau181, the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s disease-related amyloid pathologyEU CE mark for the first AI-based risk stratification tool to assess progressive decline in kidney function and for the sixth-generation Troponin T test, which shows a new level of accuracy critical in diagnosing heart attacks Outlook for 2025 earnings raised. Roche CEO Thomas Schinecker: “We continue to build on our positive momentum with strong sales growth of 7% at constant exchange rates. Our momentum is further reflected in our pipeline with a number of positive clinical read-outs and a record ten potentially transformative medicines progressing into the final phase of development for diseases with significant unmet need. By the end of the decade, we expect phase III clinical results for up to 19 new medicines. Our groundbreaking next-generation sequencing technology, set to launch next year, has achieved a new record for decoding a whole human genome in under four hours. Based on our strong results, we are raising our earnings outlook for the full year.” Sales CHF millions As % of sales % change January–September 2025 2024 2025 2024 At CER In CHF Group 45,862 44,984 100.0 100.0 7 2 Pharmaceuticals Division 35,555 34,257 77.5 76.2 9 4 United States 18,798 18,166 41.0 40.4 8 3 Europe 6,818 6,613 14.9 14.7 5 3 Japan 2,139 2,083 4.7 4.6 5 3 International** 7,800 7,395 16.9 16.5 13 5 Diagnostics Division 10,307 10,727 22.5 23.8 1 -4 **Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2025 earnings raisedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single to low double digit range (CER). Roche expects to further increase its dividend in Swiss francs. Group salesIn the first nine months of 2025, Roche achieved sales growth of 7% (2% in CHF) to CHF 45.9 billion due to strong demand for our pharmaceutical and diagnostic products. The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on sales when reported in Swiss francs compared to constant exchange rates. Sales in the Pharmaceuticals Division increased by 9% (4% in CHF) to CHF 35.6 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 15.8 billion. This represents an increase of CHF 2.4 billion at CER compared to the first nine months of 2024. This increase more than compensated for the total decrease of CHF 0.5 billion (CER) in sales of the ‘loss of exclusivity (LOE)’ products – the decline in sales of Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Lucentis (severe eye diseases) and Esbriet (lung disease) was partially offset by an increase in sales of Actemra/RoActemra (rheumatoid arthritis). In the United States, sales rose by 8% due to growth in sales of Xolair, Phesgo, Ocrevus, Hemlibra, Polivy (blood cancer) and Vabysmo. This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as strong demand for Ocrevus and Vabysmo and the continuing uptake of Polivy, Phesgo and Hemlibra more than compensated for the lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Hemlibra, Vabysmo and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Perjeta due to continued conversion of patients to Phesgo and of Avastin because of biosimilar erosion. Sales in the International region grew by 13%, led by Phesgo, Hemlibra, Vabysmo, Xofluza (influenza) and Kadcyla (breast cancer). In China, sales rose by 9%, driven by the uptake of Phesgo due to inclusion in the government drug reimbursement list, strong sales of Xofluza and the continued roll-out of Polivy and Vabysmo. The Diagnostics Division’s sales increased by 1% (-4% in CHF) to CHF 10.3 billion as growth in demand for pathology solutions and molecular diagnostics more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 6%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 7%, with growth across customer areas. Sales in Asia-Pacific decreased by 15% due to healthcare pricing reforms in China. Latin America sales grew by 14%. Pharmaceuticals: key developments Compound Milestone Regulatory Gazyva/ Gazyvaro Blood cancer FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis The FDA approval is based on the superiority of Gazyva/Gazyvaro over standard therapy alone, as shown by the phase II NOBILITY and phase III REGENCY data Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III studyLupus nephritis affects more than 1.7 million people worldwide, predominantly women of colour and childbearing age, with up to one-third of patients progressing to end-stage kidney disease More information: Media Release, 20 October 2025 Gazyva/ Gazyvaro Blood cancer CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis The positive recommendation is based on phase II NOBILITY and phase III REGENCY data showing the superiority of Gazyva/Gazyvaro over standard therapy aloneGazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III studyLupus nephritis is a debilitating condition that severely impacts a person’s quality of life and affects more than 1.7 million people worldwide More information: Media Release, 17 October 2025 Tecentriq Lung cancer FDA approves Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer (ES-SCLC) The combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte studyThis is the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLCThe regimen is recommended in the National Comprehensive Cancer Network Guidelines for SCLC More information: Media Release, 3 October 2025 Lunsumio Blood cancer CHMP recommends EU approval of subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphoma Lunsumio provides high and long-lasting response rates, with approximately two-thirds of patients with a complete response in remission after four yearsSubcutaneous Lunsumio has the potential to substantially reduce treatment administration time with an injection of approximately one minute, compared with an IV infusion of two to four hoursIf approved, Lunsumio would be the first treatment available for people with follicular lymphoma after two or more lines of systemic therapy, which is both fixed-duration and subcutaneously administered More information: Media Release, 19 September 2025 Susvimo Severe eye diseases Roche receives CE mark for Contivue, its port delivery platform with Susvimo, for neovascular or ‘wet’ age-related macular degeneration (nAMD) Susvimo is under review with the EMA and once approved, will be the first continuous delivery treatment for nAMD, affecting 1.7 million in the European UnionNew seven-year data from the LADDER study show Contivue with Susvimo provides good visual outcomes with stable retinal anatomy over the longer termWith up to two refills per year, Contivue with Susvimo provides reliable, long-term vision outcomes and is approved in the US for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR) More information: Media Release, 4 September 2025 Elevidys Duchenne muscular dystrophy Regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy (DMD) in the EU EMA’s CHMP issued an opinion not to recommend Elevidys for the treatment of ambulatory individuals with DMDRoche will continue its dialogue with the EMA to explore a potential path forward to make Elevidys available to individuals living with DMD in the EURoche believes the benefit-risk remains positive in the ambulatory DMD populationElevidys is the first and only disease-modifying gene therapy for DMD More information: Media Release, 25 July 2025 Phase III, pivotal and other key read-outs Tecentriq Bladder cancer Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatment Tecentriq reduced the risk of death by 41% and the risk of disease recurrence or death by 36% compared with placeboIMvigor011 is the first global phase III study to read out a pioneering ctDNA-guided approach to post-surgery treatment in muscle-invasive bladder cancerData was presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025 More information: Media Release, 20 October 2025 Giredestrant Breast cancer Phase III evERA data showed that giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancer Giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in the intent-to-treat (ITT) and ESR1-mutated populations, respectively, in a post-CDK inhibitor setting, compared with standard-of-care endocrine therapy plus everolimusThe giredestrant combination was well tolerated; no new safety signals were observed including no photopsiaIf approved, giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader combination in the post-CDK inhibitor setting More information: Media Release, 18 October 2025 Vamikibart Severe eye disease Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss Vamikibart is the first non-steroid targeted therapy designed to address inflammation driving UME and may offer a potential new treatment option for patientsVision improvements were seen in both pivotal studies, achieving statistical significance in MEERKAT and nominal significance in SANDCATThe MEERKAT and SANDCAT trials are ongoing and the data will be discussed with health authorities globally More information: Media Release, 17 October 2025 Ocrevus/ Fenebrutinib Multiple sclerosis Roche presents new data for Ocrevus and fenebrutinib across broad patient populations at the 2025 Conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Ocrevus subcutaneous maintains a consistent benefit-risk profile after two yearsNew late-breaking data confirm that Ocrevus significantly reduces disability progression in adults with advanced primary progressive multiple sclerosis (PPMS)One-year data reinforce that the majority of infants potentially exposed to Ocrevus during pregnancy or breastfeeding exhibit antibody responsesFenebrutinib two-year phase II data demonstrate near-complete suppression of disease activity at 96 weeks More information: Media Release, 24 September 2025 Giredestrant Breast cancer Positive phase III results show giredestrant significantly improved progression-free survival in ER-positive advanced breast cancer evERA met its co-primary endpoints; giredestrant plus everolimus demonstrated significant benefit in intent-to-treat (ITT) and ESR1-mutated populations in the post-CDK inhibitor setting, compared with standard of care plus everolimusThe all-oral combination was well tolerated and adverse events were consistent with the known safety profiles of the individual study treatments; no new safety signals were observedevERA is the first positive head-to-head phase III trial investigating an all-oral selective oestrogen receptor degrader-containing regimen versus a standard of care combination More information: Media Release, 22 September 2025 Vabysmo Severe eye diseases New data for Vabysmo reinforce its efficacy, safety and durability in neovascular or ‘wet’ age-related macular degeneration (nAMD) In AVONELLE-X, the largest long-term extension trial in nAMD, disease control and durability were maintained over four years, with nearly 80% of patients on extended dosing by study endOver 60% of people with a difficult-to-treat form of nAMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observedVabysmo was well tolerated with a consistent long-term safety profile in nAMD in both studies More information: Media Release, 5 September 2025 Susvimo Severe eye diseases Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD) Susvimo is the only continuous delivery treatment to provide reliable, long-term vision outcomes in nAMD, the leading cause of vision loss in people over the age of 60With two refills per year, Susvimo maintained vision and stabilised the retina for five years, with durability maintained in approximately 95% of patientsSusvimo was well tolerated over five years and has a well-characterised safety profile More information: Media Release, 1 August 2025 Trontinemab Alzheimer’s disease Roche presents new insights in Alzheimer’s disease research across its diagnostics and pharmaceuticals portfolios at the Alzheimer’s Association International Conference (AAIC) Trontinemab’s phase Ib/IIa Brainshuttle AD study continues to show rapid and robust clearance of amyloid plaques, with 91% becoming amyloid PET negative and ARIA-E remaining <5%Design of the phase III TRONTIER 1 and 2 studies of trontinemab in early symptomatic Alzheimer’s disease featured, with initiation planned in 2025Plans for new phase III trial investigating trontinemab in preclinical Alzheimer’s disease, in people at high risk of cognitive declineNew real-world data support Elecsys pTau217 as a stand-alone blood test, comparable to a PET scan, for rule-in and rule-out identification of amyloid pathology More information: Media Release, 28 July 2025 Other Data at ESMO Roche data presented at the European Society for Medical Oncology (ESMO) Congress 2025 showcase advances in science and cancer care across multiple tumour types Roche presented more than 30 abstracts across more than 10 cancer types at the ESMO Congress 2025, held 17‒21 October 2025 in Berlin, GermanyThe data underscore Roche’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers More information: Media Release, 13 October 2025 Change in Board of Directors Change in the Roche Board of Directors Dr Claudia Suessmuth Dyckerhoff has decided not to stand for re-election as a member of the Roche Board of Directors at the Annual General Meeting in 2026She will be nominated for election to the board of another company which is serving the healthcare industryDr Claudia Suessmuth Dyckerhoff has served on the Roche Board of Directors since March 2016 More information: Media Release, 3 October 2025 89bio tender offer Roche commences tender offer for all shares of 89bio, Inc. for USD 14.50 per share in cash, plus a non-tradeable contingent value right for up to USD 6.00 per share in cash The tender offer is being made pursuant to the previously announced merger agreement dated as of 17 September 2025, among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Bluefin Merger Subsidiary, Inc., a wholly owned subsidiary of Roche Holdings, Inc., and 89bioThe tender offer period will expire at one minute after 11:59 p.m., New York City time on 29 October 2025, unless the offer is extended More information: Media Release, 1 October 2025 89bio merger agreement Roche enters into a definitive merger agreement to acquire 89bio and its phase III FGF21 analogue for the therapy of moderate to severe metabolic dysfunction-associated steatohepatitis (MASH) 89bio’s pegozafermin allows for a potentially best-in-disease treatment for moderate to severe MASH, one of the most prevalent comorbidities of obesityThe acquisition supports Roche’s strategy as it enhances the company’s portfolio in cardiovascular, renal and metabolic diseases and offers optionality for future combination developmentRoche will acquire 89bio for USD 14.50 per share in cash at closing, representing a total equity value of approximately USD 2.4 billion. Stockholders would also receive a non-tradeable contingent value right for up to an aggregate of USD 6.00 per share in cash, representing a total deal value of up to approximately USD 3.5 billion More information: Media Release, 18 September 2025 Zilebesiran Hypertension Roche and Alnylam advance zilebesiran into a global phase III cardiovascular outcomes trial for people with uncontrolled hypertension Phase III trial informed by comprehensive KARDIA data set generated through three phase II studies: KARDIA-1, KARDIA-2 and KARDIA-3In the phase II KARDIA-3 study, presented as a late breaker at the European Society of Cardiology Congress 2025, zilebesiran demonstrated clinically meaningful reductions in office systolic blood pressure at month three with continuous control through month sixZilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives More information: Media Release, 30 August 2025 North Carolina manufacturing facility Roche’s US subsidiary Genentech breaks ground on state-of-the-art manufacturing facility in North Carolina, USA The USD 700 million project is part of Roche’s USD 50 billion investment in US manufacturing, infrastructure and R&DThe facility will create more than 1,900 jobs and support the production of next-generation metabolic medicines, including treatments for obesityThese investments underscore Roche’s commitment to innovative manufacturing, designed to bring life-changing treatments to patients faster More information: Media Release, 25 August 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–September 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 35,555 34,257 100.0 100.0 9 4 United States 18,798 18,166 52.9 53.0 8 3 Europe 6,818 6,613 19.2 19.3 5 3 Japan 2,139 2,083 6.0 6.1 5 3 International 7,800 7,395 21.9 21.6 13 5 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 CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 5,190 7 3,613 4 1,060 12 - - 517 24 HemlibraHaemophilia A 3,526 12 1,941 7 740 9 275 9 570 45 VabysmoEye diseases (nAMD, DME, RVO) 3,063 13 2,139 4 556 24 105 26 263 115 TecentriqCancer immunotherapy 2,616 1 1,222 -3 650 2 262 -3 482 15 Perjeta2Breast cancer 2,316 -13 968 -2 418 -15 54 -39 876 -19 Xolair2Asthma, food allergies 2,226 34 2,226 34 - - - - - - Actemra/RoActemra2RA, COVID-19 1,893 2 926 2 450 -10 230 5 287 19 PhesgoBreast cancer 1,827 54 523 35 602 13 139 63 563 193 Kadcyla2Breast cancer 1,531 8 577 5 396 -6 68 -2 490 28 EvrysdiSpinal muscular atrophy 1,293 8 468 14 450 5 68 6 307 5 AlecensaLung cancer 1,190 8 420 18 197 -8 151 8 422 7 PolivyBlood cancer 1,101 40 497 27 228 63 153 10 223 94 MabThera/Rituxan2Blood cancer, RA 933 -4 575 -2 104 -2 11 -11 243 -9 Activase/TNKase2Cardiac diseases 833 -2 797 -2 - - - - 36 -13 Herceptin2Breast and gastric cancer 817 -19 175 -9 223 0 6 -46 413 -29 Avastin2Various cancer types 763 -15 225 -19 54 -14 111 -23 373 -10 Gazyva/Gazyvaro2Blood cancer 728 13 376 18 183 1 25 20 144 17 Pulmozyme2Cystic fibrosis 361 16 254 25 49 -10 - -8 58 8 CellCept2Immunosuppressant 292 7 14 -11 97 22 34 28 147 -2 Madopar2Parkinson’s disease 273 3 - - 70 -3 - - 203 6 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone Kidney Klinrisk Algorithm Kidney disease Roche receives CE Mark for AI-based Kidney Klinrisk Algorithm and launches new comprehensive chronic kidney disease (CKD) algorithm panel Roche, in collaboration with KlinRisk, Inc, has received CE-mark for the first AI-based risk stratification tool for assessment of progressive decline in kidney functionThis tool will be launched as part of Roche’s new chronic kidney disease (CKD) algorithm panel to support care across the stages of the disease which affects 700 million people globallyClinicians can use the CKD panel (Kidney Klinrisk Algorithm and Kidney KFRE Algorithm) to evaluate a patient’s risk of kidney function decline, including in the early asymptomatic stages of the disease More information: Media Release, 6 October 2025 Troponin T test Heart attacks Data show Roche’s sixth-generation Troponin T test offers a new level of accuracy critical for diagnosing heart attacks Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy for faster and more reliable diagnosis in emergenciesThe test helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunityThe global TSIX clinical study involved more than 13,000 participants, validating performance across a diverse population that reflects real-world healthcare settings More information: Media Release, 30 September 2025 Elecsys pTau181 Alzheimer’s disease Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR)-certified test to rule out Alzheimer’s-associated amyloid pathologyThe minimally invasive blood-based test can serve as a rule-out for Alzheimer’s pathology, reducing the need for confirmatory testing with a negative resultData from clinical study supports use in primary care for people with varying signs of cognitive decline More information: Media Release, 23 July 2025 Diagnostics sales Sales CHF millions As % of sales % change January–September 2025 2024 2025 2024 At CER In CHF Diagnostics Division 10,307 10,727 100.0 100.0 1 -4 Customer areas3 Core Lab 5,688 6,057 55.2 56.5 -1 -6 Molecular Lab 1,861 1,876 18.1 17.5 4 -1 Near Patient Care 1,477 1,611 14.3 15.0 -4 -8 Pathology Lab 1,281 1,183 12.4 11.0 13 8 Regions Europe, Middle East, Africa 3,686 3,589 35.8 33.5 6 3 North America 3,305 3,222 32.1 30.0 7 3 Asia-Pacific 2,547 3,146 24.7 29.3 -15 -19 Latin America 769 770 7.4 7.2 14 0 More information on Roche performance in the first nine months of 2025: Q3 2025 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly.* Susvimo is approved in the US by the Food and Drug Administration (FDA) for nAMD, diabetic macular edema (DME) and diabetic retinopathy (DR). It is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD. Cautionary statement regarding forward-looking statementsThis 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 RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 32 17e-mail: kalm.loren@gene.com Attachments Media & Investor Release Q3 2025 English Communications appendix tables_YTD Sep 2025_Sales