Basel, 23 October 2025
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 raised
Roche (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 sales
In 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/ GazyvaroBlood cancer | FDA approves Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritisThe 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 dataGazyva/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/ GazyvaroBlood cancer | CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritisThe 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 |
| TecentriqLung 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 SCLCMore information: Media Release, 3 October 2025 |
| LunsumioBlood cancer | CHMP recommends EU approval of subcutaneous formulation of Lunsumio for people with relapsed or refractory follicular lymphomaLunsumio 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 administeredMore information: Media Release, 19 September 2025 |
| SusvimoSevere 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 |
| ElevidysDuchenne muscular dystrophy | Regulatory update on Elevidys gene therapy for Duchenne muscular dystrophy (DMD) in the EUEMA’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 | |
| TecentriqBladder cancer | Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatmentTecentriq 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 2025More information: Media Release, 20 October 2025 |
| GiredestrantBreast cancer | Phase III evERA data showed that giredestrant significantly improved progression-free survival in people with ER-positive advanced breast cancerGiredestrant 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 settingMore information: Media Release, 18 October 2025 |
| VamikibartSevere eye disease | Roche presents new phase III pivotal data for vamikibart in uveiticmacular edema (UME), a serious cause of vision lossVamikibart 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 globallyMore information: Media Release, 17 October 2025 |
| Ocrevus/ FenebrutinibMultiple 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 weeksMore information: Media Release, 24 September 2025 |
| GiredestrantBreast cancer | Positive phase III results show giredestrant significantly improved progression-free survival in ER-positive advanced breast cancerevERA 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 combinationMore information: Media Release, 22 September 2025 |
| VabysmoSevere 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-tre |