Pirfenidone

Financing led by Suvretta Capital Management and SR One with participation from 16 additional healthcare investors Proceeds will support key clinical milestones across all of Avalyn’s pipeline programs July 22, 2025 -- Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on the development of inhaled therapies for the treatment of life-threatening pulmonary diseases, today announced the closing of an oversubscribed $100 million Series D financing. The raise was co-led by Suvretta Capital Management and SR One, with participation from Novo Holdings A/S, F-Prime, Perceptive Xontogeny Venture Funds, Norwest, Eventide Asset Management, Wellington Management, Vida Ventures, Catalio Capital Management, RiverVest Venture Partners, Pivotal bioVenture Partners, TPG Biotech, Hamilton Square Partners Management, LP (HSq), Rock Springs Capital, Surveyor Capital (a Citadel company), funds and accounts advised by T. Rowe Price Associates, Inc., and Piper Heartland. In conjunction with the financing, David Friedman, M.D., Managing Director of Suvretta Capital Management, joined Avalyn’s Board of Directors and Diamantis Xylas, M.D., Partner and Head of Research of Catalio Capital Management, joined as a Board Observer. “Completing a significant round of financing despite the challenging market conditions is a testament to our innovative approach to developing potentially life-saving medicines for patients with pulmonary fibrosis,” said Lyn Baranowski, CEO of Avalyn. “We’ve made tremendous progress across our entire portfolio, completing Phase 1 clinical trials of AP02 and initiating a global Phase 2b clinical trial of AP01. With the support from an esteemed group of investors, we will continue the expeditious advancement of our clinical programs, while also bringing our third program into the clinic, all of which positions Avalyn for an exciting future of growth.” Proceeds will support key clinical milestones across Avalyn’s pipeline programs in pulmonary fibrosis, including the late-stage development of Avalyn’s lead programs: optimized inhaled formulations of pirfenidone (AP01) and nintedanib (AP02), as well as the advancement of the pirfenidone/nintedanib fixed dose combination (AP03) into Phase 1 clinical trials. AP01 is currently being evaluated in a global Phase 2b MIST trial in patients with progressive pulmonary fibrosis (PPF). In the completed Phase 1b ATLAS trial in patients with idiopathic pulmonary fibrosis (IPF), AP01 reduced lung function decline in a dose-responsive manner and demonstrated potential disease-modifying effects on fibrosis as observed by analyses of high-resolution computed tomography (HRCT) scans. In an ongoing open-label extension trial of patients with different forms of pulmonary fibrosis, AP01 has shown long-term safety and efficacy for more than 4.5 years. In addition, Avalyn recently completed Phase 1 trials of AP02, which demonstrated safety and tolerability at all dose levels and a favorable pharmacokinetic profile. The company plans to initiate a Phase 2 clinical trial for AP02 in patients with IPF. “Avalyn is at an exciting point in its evolution with multiple transformative product opportunities in clinical development, each with significant commercial potential,” said David Friedman, M.D., Managing Director of Suvretta Capital Management. “The clinical data generated to date for AP01 and AP02 are clinically compelling on their own, but when compared to the data for the currently approved oral treatments, they support the potential for Avalyn to achieve disease modification for patients with pulmonary fibrosis. We are thrilled to back such an exceptional team translating breakthrough science into real clinical impact, and what we believe will be a category-changing company in respiratory medicine.” “Lyn and team are executing a clear growth strategy for Avalyn rooted in both clinical insight and operational excellence,” said Jill Carroll, Partner at SR One and an Avalyn Board Director. “On behalf of the entire Board, we’re proud of their patient-focused approach and commitment to innovation and scientific rigor, which positions this company to redefine the future of what’s possible for patients suffering from pulmonary fibrosis.” Avalyn’s earlier-stage pipeline includes AP03, a next-generation inhaled fixed-dose combination of AP01 and AP02. Clinical data indicate that the combination of pirfenidone and nintedanib may offer additive, or even synergistic, efficacy advantages over either product alone. Combining these oral therapies has not been feasible due to the additive side effects when taken together. Inhaled delivery has the potential to solve the tolerability challenges of the oral antifibrotics, enabling Avalyn to combine these medicines effectively for the first time. Avalyn is advancing IND-enabling studies for AP03 and is planning a Phase 1 clinical trial. Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, and reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn’s inhaled approach tackles the underlying pathophysiology of pulmonary fibrosis at its source and is designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn’s AP01 is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b study in progressive pulmonary fibrosis (PPF). AP01 has been assessed in over 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety compared to historical data with existing therapies. The company completed two Phase 1 studies for AP02, inhaled nintedanib, for the treatment of idiopathic pulmonary fibrosis (IPF). The content above comes from the network. if any infringement, please contact us to modify.

Basel, 24 July 2025 Group sales grew by 7%1 at constant exchange rates (CER; 4% in CHF), driven by strong demand for medicines.Pharmaceuticals Division sales rose by 10% (6% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (severe eye diseases) and Ocrevus (multiple sclerosis) being the top growth drivers.Diagnostics Division sales were stable (-3% in CHF) as strong demand for pathology solutions and blood screening tests offset the impact of healthcare pricing reforms in China.Core operating profit increased by 11% (6% in CHF), driven by higher sales and effective cost management.Core earnings per share showed significant growth of 12% (8% in CHF); IFRS net income jumped by 23% (17% in CHF).Outlook for 2025 confirmed.Highlights: US approval for Susvimo for diabetic retinopathy, a potentially blinding eye diseaseEU approval for Itovebi for a type of advanced breast cancer and Evrysdi tablet for spinal muscular atrophyCHMP recommendation for EU label update for Phesgo for breast cancer to allow at-home administrationAdvancement of key molecules into phase III development: prasinezumab for early-stage Parkinsonߴs disease and zosurabalpin for life-threatening bacterial infectionsPositive data on several therapies: Lunsumio and Polivy combination and Columvi for blood cancer, Tecentriq for lung cancer, Itovebi and Perjeta for breast cancer and fenebrutinib for multiple sclerosis and NXT007 for haemophilia AIntroduction of innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severityAnnouncement of new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technologyUS approval for VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify a form of lung cancer in patients eligible for targeted treatmentUS Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer Outlook for 2025 confirmedRoche (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 digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2025 2024 At CER1 In CHF Group sales 30,944 29,848 7 4 Pharmaceuticals Division 23,985 22,637 10 6 Diagnostics Division 6,959 7,211 0 -3 Core operating profit 12,010 11,293 11 6 Core EPS – diluted (CHF) 11.08 10.23 12 8 IFRS net income 7,832 6,697 23 17 Roche CEO Thomas Schinecker: “Roche’s strong growth momentum continued in the second quarter, driven by the strong growth of 11% at constant exchange rates in our Pharmaceuticals Division. We received numerous important approvals and reported positive data in disease areas with high unmet medical need. Over the past six months, we have made significant progress in our pipeline and advanced four potentially practice-changing therapies into the final phase of clinical development, based on encouraging data: NXT007 in haemophilia A, trontinemab in Alzheimer’s disease, prasinezumab in early-stage Parkinson’s disease, and zosurabalpin, a novel antibiotic that could become the first in over 50 years to tackle a type of bacteria that has become resistant to most other treatments. We are confident in our continued strong momentum and resilience of our business due to our innovative on-market portfolio and pipeline. Based on these strong results, we confirm our full-year outlook.” Group resultsIn the first half of 2025, Roche achieved sales growth of 7% (4% in CHF) to CHF 30.9 billion due to strong demand for pharmaceutical products. Core operating profit increased by 11% (6% in CHF) to CHF 12.0 billion, driven by higher sales and effective cost management. The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on the results when reported in Swiss francs compared to constant exchange rates. Core earnings per share increased by 12% (8% in CHF). IFRS net income increased by 23% (17% in CHF) to CHF 7.8 billion, driven by the strong operating performance and lower impairment charges related to intangible assets. Sales in the Pharmaceuticals Division increased by 10% (6% in CHF) to CHF 24.0 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 10.6 billion. This represents an increase of CHF 1.7 billion at CER compared to the first half of 2024. This more than compensated for the total decrease of CHF 0.3 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 10% due to continued growth of Xolair and continuing uptake of Hemlibra, Ocrevus, Vabysmo and Phesgo. This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as the continued roll-out of Vabysmo and the continuing uptake of Ocrevus, Polivy and Phesgo more than compensated for 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, 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 14%, led by Phesgo, Hemlibra, Xofluza (influenza), Vabysmo and Elevidys (Duchenne muscular dystrophy). In China, sales rose by 9%, driven by the uptake of Phesgo, strong sales of Xofluza and the roll-out of Polivy and Vabysmo. The Diagnostics Division’s sales remained stable (-3% in CHF) at CHF 7.0 billion as growth in demand for pathology solutions and blood screening tests offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 5%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 6%, 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 ItovebiBreast cancer European Commission approves Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation Approval based on INAVO120 data showing that the regimen based on Itovebi more than doubled progression-free survival compared with palbociclib and fulvestrant alone. Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need.Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis. More information: Media Release, 23 July 2025 EvrysdiSpinal muscular atrophy Evrysdi tablet approved by European Commission as first and only tablet for spinal muscular atrophy (SMA) Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with SMA.Evrysdi tablet offers the same efficacy and safety demonstrated in available oral solution.Evrysdi is the only non-invasive disease-modifying SMA treatment, with more than 18,000 people with SMA treated globally to date. More information: Media Release, 4 June 2025 SusvimoSevere eye diseases FDA approves Susvimo for diabetic retinopathy Susvimo can help people with diabetic retinopathy maintain their vision and prevent progression to blindness with only one treatment every nine months.The innovative technology of Susvimo via the Port Delivery Platform may offer an alternative to regular eye injections in the US.Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema. More information: Media Release, 22 May 2025 ColumviBlood cancer Update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the phase III STARGLO study.There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL.This first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for patients who face poor prognosis.The clinical and disease characteristics of the overall population enrolled in this multiregional clinical trial are representative and applicable to US patients. More information: Media Release, 20 May 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 23,985 22,637 100.0 100.0 10 6 United States 12,670 11,882 52.8 52.5 10 7 Europe 4,566 4,425 19.0 19.5 5 3 Japan 1,425 1,366 5.9 6.0 5 4 International 5,324 4,964 22.3 22.0 14 7 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 3,506 8 2,462 5 706 12 - - 338 19 HemlibraHaemophilia A 2,421 17 1,324 11 493 7 183 8 421 66 VabysmoEye diseases (nAMD, DME, RVO) 2,067 18 1,450 9 378 33 70 31 169 118 TecentriqCancer immunotherapy 1,733 -1 819 -6 434 3 174 -4 306 13 Perjeta2Breast cancer 1,613 -12 677 1 282 -16 37 -44 617 -18 Xolair2Asthma, food allergies 1,445 34 1,445 34 - - - - - - Actemra/RoActemra2RA, COVID-19 1,279 4 619 7 308 -14 152 5 200 26 PhesgoBreast cancer 1,197 55 348 39 401 15 90 80 358 182 Kadcyla2Breast cancer 1,037 9 396 7 266 -6 45 -2 330 28 EvrysdiSpinal muscular atrophy 869 7 309 12 292 4 46 5 222 5 AlecensaLung cancer 802 8 276 20 133 -7 100 5 293 7 PolivyBlood cancer 730 46 327 32 160 90 99 8 144 88 MabThera/Rituxan2Blood cancer, RA 630 -8 387 -6 70 -8 7 -14 166 -11 Herceptin2Breast and gastric cancer 560 -21 121 -10 150 -1 4 -51 285 -32 Activase/TNKase2Cardiac diseases 550 -4 527 -3 - - - - 23 -25 Avastin2Various cancer types 522 -17 156 -20 26 -40 76 -25 264 -9 Gazyva/Gazyvaro2Blood cancer 490 14 253 20 121 1 17 20 99 14 Pulmozyme2Cystic fibrosis 239 11 167 22 34 -12 - -18 38 -3 CellCept2Immunosuppressant 196 2 9 -17 65 12 24 35 98 -6 Madopar2Parkinson’s disease 193 1 - - 46 -5 - - 147 4 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX sequencing technologyGenetic disorders Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology The strategic collaboration with Broad Clinical Labs will explore and develop applications using Roche’s SBX sequencing technology, with an initial focus on critically ill newborns and their parents.Whole-genome sequencing can help diagnose babies with suspected genetic disorders, such as cystic fibrosis and sickle cell disease.This project will explore how this technology could become part of routine clinical practice for newborns, as well as its use in other research applications. More information: Media Release, 23 May 2025 VENTANA MET (SP44) RxDx AssayLung cancer FDA approves VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for targeted treatment The VENTANA MET (SP44) RxDx Assay detects the MET (also known as c-Met) protein, which is over-expressed in some patients with non-squamous non-small cell lung cancer.The MET protein serves as a predictive biomarker for the likelihood of a patient’s response to c-Met-targeted therapy.As the leader in companion diagnostics, Roche offers a broad CDx portfolio that helps enable informed clinical decisions and improved patient outcomes. More information: Media Release, 14 May 2025 Elecsys PRO-C3 testLiver fibrosis Roche introduces the innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity Elecsys PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses the severity of liver fibrosis – a disease responsible for approximately one in every 25 deaths worldwide.The test delivers results in just 18 minutes on Roche’s cobas analysers, providing a fast and reliable diagnostic method.The test enables earlier identification of patients with significant liver fibrosis, potentially improving outcomes through timely management and access to emerging therapies. More information: Media Release, 6 May 2025 VENTANA TROP2 (EPR20043) RxDx deviceLung cancer FDA grants Roche Breakthrough Device Designation for the first AI-driven companion diagnostic for non-small cell lung cancer The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to determine patient treatment. The device uses AI-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods. This Breakthrough Device Designation demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology. More information: Media Release, 29 April 2025 Chest pain triage algorithmAcute coronary syndrome Roche receives CE mark for its chest pain triage algorithm to enhance detection of acute coronary syndrome Roche, in collaboration with Universitätsklinikum Heidelberg, has developed a chest pain triage algorithm – a CE-marked IVD medical device set to transform cardiac care.This novel algorithm offers a standardised assessment, helping emergency room doctors to make confident clinical decisions in ruling in or ruling out heart attacks (acute myocardial infarction).Cardiovascular disease causes a third of worldwide deaths, with chest pain being the second highest reason for emergency department visits. More information: Media Release, 23 April 2025 PhesgoBreast cancer CHMP recommends EU label update for Phesgo to allow administration outside clinical settings Positive recommendation is based on clinical, real-world and bioequivalence data supporting feasibility and safety of the administration of Phesgo outside clinical settings, for example at home.Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings.Phesgo has the potential to reduce treatment administration costs by up to 80% in Western Europe, and 85% of patients prefer subcutaneous over intravenous administration. More information: Media Release, 30 April 2025 Phase III, pivotal and other key read-outs AstegolimabChronic obstructive pulmonary disease (COPD) Roche provides update on astegolimab in chronic obstructive pulmonary disease The pivotal phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualised exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks.The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks.The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified. More information: Media Release, 21 July 2025 NXT007Haemophilia A Early data suggest NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest-dose groups in people with haemophilia A.The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden.Three phase III clinical studies on NXT007, a next-generation bispecific antibody, are set to begin in 2026. More information: Media Release, 23 June 2025 Lunsumio and PolivyBlood cancer Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma Pivotal phase III SUNMO study demonstrated an 11.5-month median progression-free survival – three times longer than R-GemOx.This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care.These data demonstrate Roche’s commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma. More information: Media Release, 20 June 2025 PrasinezumabParkinson’s disease Roche to advance prasinezumab into phase III development for early-stage Parkinson’s disease Results from phase IIb PADOVA and longer-term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson’s disease.Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody targeting a known biological driver of Parkinson’s disease progression.Parkinson’s disease affects over 10 million people globally and significant unmet need remains. More information: Media Release, 16 June 2025 TecentriqLung cancer Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer (ES-SCLC) 46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options.First phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival. Data were presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet. More information: Media Release, 3 June 2025 ItovebiBreast cancer New data show Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer The regimen based on Itovebi reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone.The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis.New data were presented in an oral session at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine. More information: Media Release, 31 May 2025 FenebrutinibMultiple sclerosis Fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment.Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end. More information: Media Release, 30 May 2025 ColumviBlood cancer New two-year follow-up data show Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) patients Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant.89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment.Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease. Results demonstrate the potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option. More information: Media Release, 23 May 2025 PerjetaBreast cancer Ten-year APHINITY data show regimen based on Perjeta reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer Long-term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adjuvant Perjeta was added to Herceptin and chemotherapy.21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease. More information: Media Release, 13 May 2025 Other Executive changes Changes to the Roche Enlarged Corporate Executive Committee Johannes (Hans) Clevers, MD, PhD, Head of Roche Pharma Research and Early Development (pRED) and member of the Enlarged Corporate Executive Committee, will be retiring from Roche. Barbara Schädler, Head of Group Communications and member of Roche’s Enlarged Corporate Executive Committee, will retire from the company at the end of the year. More information: Media Release, 30 June 2025 ElevidysDuchenne muscular dystrophy Roche provides safety update on Elevidys gene therapy for Duchenne muscular dystrophy in non-ambulatory patients After a thorough clinical review, the benefit-risk profile of Elevidys in non-ambulatory patients with Duchenne has been re-assessed following two cases of fatal acute liver failure.Effective immediately, dosing of non-ambulatory patients, irrespective of age, is paused in the clinical setting; dosing of non-ambulatory patients is discontinued in the commercial setting.Roche is working closely with relevant health authorities, investigators and prescribing physicians to ensure they are informed and patient care is being appropriately modified.The benefit-risk profile of Elevidys treatment in ambulatory Duchenne patients remains positive and treatment guidance is unchanged. More information: Media Release, 15 June 2025 XofluzaInfluenza The New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread, of the influenza virus from an infected person to household members by 32%.CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus.Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems. More information: Media Release, 25 April 2025 Diagnostics sales Sales CHF millions As % of sales % change January–June 2025 2024 2025 2024 At CER In CHF Diagnostics Division 6,959 7,211 100.0 100.0 0 -3 Customer areas3 Core Lab 3,839 4,072 55.2 56.5 -2 -6 Molecular Lab 1,250 1,257 18.0 17.4 3 -1 Near Patient Care 1,018 1,094 14.6 15.2 -3 -7 Pathology Lab 852 788 12.2 10.9 12 8 Regions Europe, Middle East, Africa 2,485 2,431 35.7 33.7 5 2 North America 2,235 2,163 32.1 30.0 6 3 Asia-Pacific 1,729 2,102 24.9 29.2 -15 -18 Latin America 510 515 7.3 7.1 14 -1 More information on Roche performance in the first half of 2025: HY 2025 Finance ReportHY 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 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 Dr Rebekka SchnellPhone: +41 79 205 27 03 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 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 Roche HY results 2025 English Communications appendix tables_HY 2025_Sales_Results