Lurbinectedin

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

NetworkNewsWire Editorial Coverage NEW YORK, July 7, 2025 /PRNewswire/ -- An estimated 20 million people are diagnosed annually with cancer, while cancer kills almost 10 million people a year worldwide () with these numbers expected to grow. The American Cancer Society projects that by 2050, 35 million people will be diagnosed with cancer every year. Despite significant progress made in treating the disease, there is still a desperate need — and an enormous market potential — for new and more effective cancer drugs. Calidi Biotherapeutics Inc. (NYSE American: CLDI) (Profile) is committed to developing a novel approach to treating cancer through the precise delivery of genetic medicines to both primary tumors and metastatic sites of disease. This cutting-edge platform, which harnesses engineered viruses that can target sites of cancer in the body and deliver potent genetic medicines to attack tumors, has the potential to revolutionize the way cancer is treated. And while cancer is the initial focus for Calidi, the company has also begun to assess the potential of this technology in other areas of large unmet need such as autoimmune disease. Calidi is joining an elite group of high-quality companies focused on making a difference in the world of cancer and genetic medicines, including Regeneron Pharmaceuticals Inc. (NASDAQ: REGN), CG Oncology Inc. (NASDAQ: CGON), Roche (OTCQX: RHHBY) and Merck & Co. Inc. (NYSE: MRK). Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide. Calidi's decade-long development journey has culminated in novel precision genetic medicine delivery platforms with real therapeutic promise. The company has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration that delivers IL-15 superagonist directly to tumor sites, including metastatic cancers . Calidi Biotherapeutics has unveiled compelling preclinical data this year at two of the most influential oncology conferences. Click here to view the custom infographic of the Calidi Biotherapeutics Inc. editorial. Sustained Investment in Research, Development Cancer remains one of the most devastating health challenges facing the globe today, responsible for about one in six deaths worldwide (). The most common cancer types worldwide include lung cancer (accounting for around 2.2 million new cases and 1.8 million deaths in 2020), breast cancer (2.26 million new cases), colorectal cancer (1.93 million) and prostate cancer (1.41 million). In the United States, cancer claims more than 600,000 lives each year, with more than two million new cases expected in 2025 alone. These figures highlight both the scale of human suffering and the enormous burden cancer places on health systems around the world. These statistics underscore the importance of sustained investment in research and development. The global oncology drugs market was valued at approximately $190.1 billion in 2023 and is projected to grow to more than $564.5 billion by 2033, reflecting a compound annual growth rate (CAGR) of 11.5% over the forecast period (). This rapid expansion highlights the critical role of sustained investment in research and development, which drives advancements in early detection, targeted therapies, immunotherapies and personalized medicine — key tools in reducing the overwhelming global cancer burden Advancing Precision Delivery of Genetic Medicines Calidi Biotherapeutics Inc (NYSE American: CLDI) has spent more than a decade developing a breakthrough technology platform that enables the systemic delivery of genetic medicines to targeted tumor sites, including metastatic sites in cancer patients. At the core of this innovation is the company's proprietary engineered viral system, which cloaks therapeutic payloads in a protective human cell membrane (the "envelope") designed to evade the immune system and reach distant metastases with precision where genetic medicines that can drive tumor clearance are expressed. Calidi's decade-long development journey, from stem cell-based delivery systems to the enveloped systemic virotherapies, has culminated in novel precision genetic delivery platforms with real therapeutic promise. The company's preclinical breakthroughs have been detailed in peer-reviewed conferences and investor communications, leading to upcoming IND filing goals and potential partnerships on the horizon. Calidi appears to be well positioned to pioneer a new era of targeted cancer treatment, where genetic payloads reach disease sites directly, immune activation is localized, and patients benefit from safer, more effective therapies. Understanding the Platform Calidi Biotherapeutics is clinical stage biotechnology company that is developing genetic medicines and proprietary genetically engineered oncolytic viruses. Calidi's RedTail systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain designed to target all tumor sites (). The platform is capable of producing a high amount of enveloped vaccinia viruses resistant to humoral immunity. The technology allows the therapy to reach tumor sites and kill tumors by expressing genetic medicines in the tumor microenvironment. According to the company, the lead candidate from the RedTail platform, CLD-401, targets lung cancer and other tumor types with high unmet medical need. Pioneering Systemic Cancer Targeting Calidi Biotherapeutics has taken a decisive step in the fight against advanced and hard-to-treat cancers with CLD-401, its first compound designed for systemic administration. This lead candidate harnesses the company's decade-long innovation in enveloped viral delivery to simultaneously destroy cancer cells and deliver genetic medicine aimed at preventing disease recurrence at metastatic sites. By enabling intravenous administration, CLD–401 ushers in a new era of precision oncology where genetic payloads reach tumors throughout the body, rather than relying on localized injections. Central to CLD–401's mechanism is the company's proprietary RedTail platform. CLD–401 is an enveloped oncolytic vaccinia virus engineered to express a chimeric CD55 receptor, significantly enhancing its resistance to immune clearance and enabling systemic circulation to metastatic tumors. Loaded with an IL–15 superagonist payload, the virus not only lyses tumor cells but also delivers powerful genetic material directly into the tumor. This cytokine-based genetic medicine activates CD8+ T cells and natural killer cells, effectively transforming "cold" tumors into immunologically "hot" targets. Preclinical data has confirmed the platform's potential. "Of particular excitement is the rapid progress we have made with RedTail, the company's approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus," reported Calidi CEO Dr. Eric Poma in a recent shareholder letter (). "RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company's main focus and priority." Sharing Compelling Preclinical Data Calidi Biotherapeutics has unveiled compelling preclinical data at two of the most influential oncology conferences — the American Association of Cancer Research (AACR) and the American Association of Clinical Oncology (ASCO) — highlighting the tumor-clearing and recurrence-blocking potential of CLD–401. At the AACR Annual Meeting, held in April 2025, Calidi presented key findings under the title "Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites" (). The data revealed that RedTail's enveloped vaccinia virus, coated with a human-like extracellular envelope, can survive immune defenses, access multiple tumor sites following intravenous administration and induce strong tumor killing even in traditionally hard-to-treat metastatic lung models, by delivering genetic medicines such as IL-15 superagonist directly to the tumor. The abstract emphasized the platform's ability to evade complement activation, substantially improving systemic circulation time and therapeutic impact. The momentum continued into the ASCO Annual Meeting in June 2025, where Calidi presented results demonstrating that CLD–401, enhanced with a chimeric CD55 receptor, further resists immune clearance and delivers its IL-15 superagonist payload directly into tumors (). This immune payload triggered robust expansion of CD8+ T cells and natural killer cells in the tumor microenvironment, key players in sustained anti-tumor immunity. Collectively, these data sets presented at AACR and ASCO illustrate the dual potency of CLD–401: it both breaks down tumor tissue and educates the immune system to prevent relapse. The systemic reach of RedTail, along with its tumor-targeted immune stimulation, positions Calidi's platform as a significant advancement in the field of immuno-oncology, especially for metastatic cancers with high unmet needs. "Looking ahead, our roadmap for the next 18 months includes multiple critical milestones," said Poma. "We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL-15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an optimized dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of RedTail in patients with metastatic disease." With promising results in hand and strategic plans in place, Calidi is positioning itself to enter human trials that may redefine how genetic medicines reach and treat cancer throughout the body. Leading Biotech Firms Share Promising Advances The global effort to transform cancer care continues to accelerate as leading biopharmaceutical companies report groundbreaking clinical data across multiple tumor types. Industry leaders are showcasing the progress of novel immunotherapies and targeted treatments aimed at some of the most challenging cancers. Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) shared new and updated data from its oncology and hematology portfolio at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (). According to the company, its 18 presentations will share the latest insights from ongoing research of approved and investigational treatment regimens across a range of difficult-to-treat cancers including non-melanoma and melanoma skin cancer, lung cancer, lymphoma and multiple myeloma. CG Oncology Inc . (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, presented key data at the 2025 American Urological Association (AUA) Annual Meeting (). The data was from the phase 3 BOND-003 Cohort C study of patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG) treatment with carcinoma in situ (CIS) with or without Ta or T1 disease. Roche (OTCQX: RHHBY) is reporting positive results from its phase 3 IMforte study of Tecentriq(R) (atezolizumab) in combination with lurbinectedin (Zepzelca(R)) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and Tecentriq (). The company noted that the data showed that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Merck & Co. Inc. (NYSE: MRK) announced that its phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers (). The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. The study is evaluating KEYTRUDA(R) (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. Together, these data presentations and reports underscore the power of innovation in oncology, where immunotherapy combinations, genetic medicine therapies and personalized treatment approaches are driving new standards of care. With each development, the cancer research community moves one step closer to achieving more durable responses, longer survival and, ultimately, potential cures. For more information, visit Calidi Biotherapeutics Inc. (NYSE American: CLDI). About NetworkNewsWire NetworkNewsWire ("NNW") is a specialized communications platform with a focus on financial news and content distribution for private and public companies and the investment community. It is one of 70+ brands within the Dynamic Brand Portfolio @ IBN that delivers : (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries ; (2) article and editorial syndication to 5,000+ outlets ; (3) enhanced press release enhancement to ensure maximum impact ; (4) social media distribution via IBN to millions of social media followers ; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today's market, NNW brings its clients unparalleled recognition and brand awareness. NNW is where breaking news, insightful content and actionable information converge. For more information, please visit Please view full terms of use and disclaimers on the NNW website applicable to all content provided by NNW, wherever published or re-published: NetworkNewsWire is powered by IBN DISCLAIMER: NetworkNewsWire (NNW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. The commentary, views and opinions expressed in this release by NNW are solely those of NNW. Readers of this Article and content agree that they cannot and will not seek to hold liable NNW for any investment decisions by their readers or subscribers. NNW is a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security. The Article and content related to the profiled company represent the personal and subjective views of the Author, and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, NNW, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment. NNW HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE. This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and NNW undertakes no obligation to update such statements. NetworkNewsWire New York, NY 212.418.1217 Office [email protected] SOURCE NetworkNewsWire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED