Rituximab/Hyaluronidase

Basel, 19 October 2023 Group sales grow by 1%1 at constant exchange rates (CER) in the first nine months, showing a strong increase of 7% in the third quarterExcluding COVID-19 products, Group sales increase by 9%Pharmaceuticals Division sales grow by 9%, driven by continued high demand for newer medicinesDiagnostics Division’s base business increases by 7%; overall divisional sales are down 18% due to a surge in demand for COVID-19 tests in 2022Highlights in the third quarter of 2023: EU approval of Evrysdi for babies under two months old with spinal muscular atrophy First approval of subcutaneous form of cancer immunotherapy Tecentriq Positive phase III data for Alecensa (early-stage lung cancer) and Ocrevus (subcutaneous injection; multiple sclerosis) Positive phase II data for zilebesiran (hypertension in patients at high risk of cardiovascular disease) and additional positive phase II data for fenebrutinib (multiple sclerosis) Positive longer-term efficacy and safety data for Ocrevus (multiple sclerosis) and Vabysmo (retinal vein occlusion, a severe eye disease)Launch of first validated test for earlier diagnosis of neonatal sepsis and new module to improve laboratory efficiency Outlook for 2023 confirmed Roche CEO Thomas Schinecker: “We achieved good results in the first nine months of 2023, more than compensating for the expected decline in demand for COVID-19 products. Our Group sales excluding COVID-19 products continued to grow strongly by +9% at constant exchange rates. Additionally, we made significant progress in our product pipeline with numerous positive clinical studies. I am particularly pleased about the phase III data for Alecensa in early-stage lung cancer. Treating cancer at an early stage may give patients a chance for a cure. We confirm our outlook for 2023.” SalesCHF millionsAs % of sales% changeJanuary–September 20232023202220232022At CERIn CHFGroup44,05347,037100.0100.01-6Pharmaceuticals Division33,62233,18976.370.691United States17,68017,19940.136.683Europe6,2596,10014.213.073Japan2,9373,0296.76.410-3International*6,7466,86115.314.612-2Diagnostics Division10,43113,84823.729.4-18-25 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Outlook for 2023 confirmedDue to the sharp decline in sales of COVID-19 products of roughly CHF 4.5 billion, Roche expects a decrease in Group sales in the low single digit range (at constant exchange rates). Excluding this COVID-19 sales decline, Roche anticipates strong sales growth in both divisions’ base business. Core earnings per share are targeted to develop broadly in line with the sales decline (at constant exchange rates). Roche expects to further increase its dividend in Swiss francs. Group salesIn the first nine months of 2023, Group sales increased by 1% (-6% in CHF) to CHF 44.1 billion, even though the company had to compensate for the significant drop in sales of COVID-19 products and the biosimilar erosion2 (a total of CHF 4.0 billion or 9% of sales). Excluding COVID-19 products, Group sales grew by 9%. The appreciation of the Swiss franc against most currencies had a significant adverse impact on the results presented in Swiss francs compared to constant exchange rates. Continued high demand for newer medicines to treat severe diseases led to a 9% increase in Pharmaceuticals Division sales, reaching CHF 33.6 billion. Roche’s top five growth drivers – Vabysmo (severe eye diseases), Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Polivy (blood cancer) and Evrysdi (spinal muscular atrophy) – collectively generated total sales of CHF 11.2 billion, marking a CHF 3.3 billion increase compared to the first nine months of 2022. In the United States, sales increased by 8%. This notable growth was primarily driven by Vabysmo, Ocrevus and Hemlibra, in contrast to declining sales of medicines with expired patent protection. Sales in Europe grew 7%, mainly driven by Germany, UK and France. Sales growth of Vabysmo, Phesgo, Evrysdi and Hemlibra was partially offset by the impact of biosimilars and the absence of sales for Ronapreve (COVID-19). Sales in Japan experienced a 10% increase, primarily driven by Ronapreve, Polivy, Vabysmo, Hemlibra, Enspryng and Tamiflu (influenza). This sales growth more than offset the impact of biosimilars. In the International region, sales grew by 12%. This encouraging trend was evident in all major markets, with Brazil and Canada leading the way. China recorded a 6% increase in sales, mainly fuelled by Tamiflu, Xeloda, Polivy and Perjeta. This more than outweighed the impact of biosimilars. Sales of the Diagnostics Division’s base business grew strongly (+7%) across all major markets. The primary drivers of growth were immunodiagnostics, particularly cardiac tests, and diagnostic solutions for clinical chemistry. Overall, the Diagnostics Division achieved sales of CHF 10.4 billion. The 18% decrease was in line with the anticipated significant drop in demand for COVID-19 tests (CHF 0.4 billion in the first nine months of 2023, in contrast to CHF 3.6 billion in the same period last year). Sales in the North America, Asia-Pacific and Europe, Middle East and Africa (EMEA) regions were down by 23%, 19% and 17%, respectively. The decline in sales across regions is primarily due to the sharp decline in demand for COVID-19 tests. Pharmaceuticals: key development milestones in the third quarter of 2023 Compound Milestone Regulatory Tecentriq SCSubcutaneous cancer immunotherapy Tecentriq becomes the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain, reducing treatment time to just minutes Tecentriq subcutaneous (SC) is now approved in Great Britain for all indications of intravenous Tecentriq, including certain types of lung, bladder, breast and liver cancer, offering a faster, more convenient option to receive treatmentAdministered under the skin within approx. seven minutes, Tecentriq SC saves time for patients and helps conserve resources in healthcare systemsEvaluations by other health authorities globally are ongoing More information: Media Release, 29 August 2023 Evrysdi Spinal muscular atrophy European Commission approves Evrysdi for babies under two months old with spinal muscular atrophy (SMA) Evrysdi now available to treat people of all ages with SMA in the European Union, including babies from birthApproval is based on interim data from ongoing RAINBOWFISH trial showing majority of babies treated with Evrysdi were able to stand and walk within timeframes typical of healthy babies by 12 months’ treatmentEvrysdi is the only non-invasive SMA therapy and is approved in more than 100 countries with more than 11,000 patients treated globally More information: Media Release, 29 August 2023 Phase III, pivotal and other key readouts; data presentations Alecensa Lung cancer Alecensa reduces the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage non-small cell lung cancer (NSCLC) These phase III data are the first and only to show an improvement in disease-free survival in early-stage resected ALK-positive NSCLCWith about one in two people with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy, more effective treatment options are urgently needed to provide the best chance for cureData are being presented as a late-breaking oral during the ESMO 2023 Presidential Symposium More information: Media Release, 18 October 2023 Fenebrutinib Multiple sclerosis Late-breaking data for BTK inhibitor fenebrutinib show brain penetration and significant reduction in lesions in patients with relapsing multiple sclerosis (MS) New data from phase II FENopta study in relapsing multiple sclerosis (RMS) show fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis More than 90% relative reduction in new/enlarging T2 lesions and new T1 gadolinium-enhancing (Gd+) lesions with fenebrutinib beginning at eight weeksThe safety profile of fenebrutinib was consistent with previous and ongoing clinical trials across more than 2,500 people to date More information: Media Release, 13 October 2023 Ocrevus subcutaneous injectionMultiple sclerosis Ocrevus twice-yearly, 10-minute subcutaneous injection is non-inferior to intravenous infusion and provided near-complete suppression of brain lesions Late-breaking phase III results show subcutaneous injection was non-inferior to intravenous (IV) infusion based on Ocrevus levels in the blood over 12 weeksOcrevus subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and near-complete suppression of MRI lesion activity in the brain over 24 weeksThe safety profile of Ocrevus subcutaneous injection was consistent with the well-established safety profile of Ocrevus IV infusionThe 10-minute subcutaneous injection has potential to improve the treatment experience for people with multiple sclerosis (MS) and expand usage in centres with IV capacity limitations More information: Media Release, 11 October 2023 Vabysmo Retinal vein occlusion Vabysmo maintains vision improvements with extended treatment intervals for up to four months for people with retinal vein occlusion (RVO) in phase III studies Vabysmo showed robust and sustained retinal drying for up to 72 weeks and a safety profile consistent with previous studiesRegulatory applications for Vabysmo in RVO are under review by health authorities around the world; if approved, RVO would be the third indication in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME) Vabysmo is the first and only treatment that targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions More information: Media Release, 10 October 2023 EvrysdiSpinal muscular atrophy Majority of newborn babies with spinal muscular atrophy (SMA) treated with Evrysdi are able to sit independently after one year of treatment RAINBOWFISH study met its primary endpoint with 80% of babies sitting without support for at least five seconds after one year of Evrysdi treatment – without treatment these babies would never be able to sitAll babies were able to swallow and feed orally and none required permanent ventilationEvrysdi is the only non-invasive SMA therapy and is approved in over 100 countries with more than 11,000 patients treated globally More information: Media Release, 4 October 2023 Ocrevus subcutaneous injectionMultiple sclerosis Fenebrutinib Multiple sclerosis Enspryng Neuromyelitis optica spectrum disorder Roche to present new key clinical and real-world data at ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in MS and NMOSD Late-breaking results from phase III trial of Ocrevus subcutaneous injection and phase II trial of BTK inhibitor fenebrutinib in multiple sclerosis (MS) will be presentedTen-year Ocrevus efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MSAdditional Ocrevus real-world and clinical data show impact for underrepresented populations including more than 3,200 pregnant women and Black and Hispanic/Latinx patients with MSLonger-term safety data and late-breaking efficacy data from phase III trial of Enspryng in neuromyelitis optica spectrum disorder (NMOSD) will be presented More information: Media Release, 2 October 2023 ZilebesiranHypertension Roche and Alnylam report positive topline results from phase II study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high risk of cardiovascular disease Zilebesiran met primary endpoint demonstrating a clinically significant reduction in 24-hour mean systolic blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM) at three months of treatment, achieving a placebo-subtracted reduction greater than 15 mmHgStudy met key secondary endpoints showing consistent reductions of systolic blood pressure at six monthsEarly results indicate the potential for zilebesiran to achieve sustained blood pressure reduction with quarterly or half-yearly dosing More information: Media Release, 7 September 2023 AlecensaLung cancer Alecensa delivers unprecedented phase III results for people with ALK-positive early-stage lung cancer (NSCLC) ALINA data demonstrate Alecensa reduces disease recurrence in the early setting for people with ALK-positive non-small cell lung cancer, building on its long-established benefit in the advanced settingAbout half of people with NSCLC experience disease recurrence following surgery, despite adjuvant chemotherapy, therefore new treatments are urgently needed to provide the best chance for cureThese data will be submitted to health authorities globally and presented at an upcoming medical meeting More information: Media Release, 1 September 2023 Tiragolumab Non-small cell lung cancer Roche provides update on phase III SKYSCRAPER-01 study in PD-L1-high metastatic non-small cell lung cancer (NSCLC) Inadvertent disclosure of the second interim analysis of the phase III SKYSCRAPER-01 study, evaluating anti-TIGIT immunotherapy tiragolumab plus Tecentriq versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancerSKYSCRAPER-01 is ongoing as planned until the final analysis of overall survival, the primary endpoint of the study, and remains blinded to patients and investigators; the interim results for the primary endpoint of overall survival were not mature at the time of the second interim analysis More information: Media Release, 23 August 2023 Pharmaceuticals sales Sales CHF millions As % of sales % change January–September 2023 2023 2022 2023 2022 At CER In CHF Pharmaceuticals Division 33,622 33,189 100.0 100.0 9 1 United States 17,680 17,199 52.6 51.8 8 3 Europe 6,259 6,100 18.4 18.4 7 3 Japan 2,937 3,029 8.7 9.1 10 -3 International* 6,746 6,861 20.3 20.7 12 -2 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top-selling medicines Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 4,767 14 3,492 12 877 12 - - 398 35 HemlibraHaemophilia A 3,112 19 1,862 17 637 22 281 15 332 36 Perjeta3Breast cancer 2,995 6 1,101 2 615 -4 161 4 1,118 15 TecentriqCancer immunotherapy 2,791 11 1,476 7 628 14 313 9 374 24 Actemra/RoActemra3RA, COVID-19 1,943 2 877 1 583 1 232 3 251 6 VabysmoEye diseases (nAMD, DME) 1,613 ** 1,320 449 185 ** 70 236 38 ** Xolair3Asthma 1,601 4 1,601 4 - - - - - - Kadcyla3Breast cancer 1,486 2 568 -3 446 -9 77 -14 395 29 Herceptin3Breast and gastric cancer 1,261 -17 258 -28 271 -15 24 -33 708 -13 MabThera/Rituxan3Blood cancer, RA 1,260 -15 761 -20 140 -7 19 -13 340 -8 Avastin3Various cancer types 1,210 -20 370 -22 78 -48 250 -25 512 -8 AlecensaLung cancer 1,126 9 340 8 220 5 157 6 409 12 EvrysdiSpinal muscular atrophy 1,065 45 381 15 374 54 67 29 243 115 Activase/TNKaseCardiac diseases 903 8 859 8 - - - - 44 7 PhesgoBreast cancer 817 66 320 56 384 53 - - 113 186 Gazyva/Gazyvaro3Blood cancer 615 22 297 25 174 25 28 -17 116 24 PolivyBlood cancer 605 126 230 100 136 70 167 181 72 372 RonapreveCOVID-19 532 -5 - - - -100 531 33 1 -99 ** Over 500% DME: diabetic macular oedema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RA: rheumatoid arthritis Diagnostics: key milestones in the third quarter of 2023 Product Milestone Elecsys IL-6 claim extensionNeonatal sepsis Roche IL-6 is the first immunoassay approved to aid sepsis diagnosis in newborns Neonatal sepsis is a leading cause of death for newbornsTesting IL-6 can indicate a neonatal sepsis infection earlier than other biomarkersEarlier diagnosis of neonatal sepsis can lead to improved outcomes and a reduction of long-term complications from sepsis More information: Media Release, 18 October 2023 CCM VerticalLaboratory module Roche launches a new addition to the cobas connection modules, the CCM Vertical, helping to improve laboratory efficiency The cobas connection modules (CCM) sample conveyors system has been extended with newly developed elevator and overhead conveyor modules enabling more flexibility in lab design CCM Vertical optimises the use of laboratory space without compromising on sample throughput of CCM up to 2,500 samples per hourThe fully modular system allows connection of different work areas in the laboratory without blocking walkways and enabling transport of samples to adjacent floors or rooms More information: Media Statement, 17 August 2023 Diagnostics sales Sales CHF millions As % of sales % change January–September 2023 2023 2022 2023 2022 At CER In CHF Diagnostics Division 10,431 13,848 100.0 100.0 -18 -25 Customer Areas4 Core Lab 5,836 5,833 56.0 42.1 9 0 Molecular Lab 1,647 2,735 15.8 19.8 -35 -40 Pathology Lab 1,046 975 10.0 7.0 15 7 Diabetes Care 1,037 1,219 9.9 8.8 -6 -15 Point of Care 865 3,086 8.3 22.3 -70 -72 Regions Europe, Middle East and Africa 3,569 4,595 34.2 33.2 -17 -22 North America 2,853 3,923 27.5 28.3 -23 -27 Asia-Pacific 3,263 4,522 31.3 32.7 -19 -28 Latin America 746 808 7.0 5.8 6 -8 More information on Roche sales in the first nine months of 2023: Investor presentation Q3 2023Appendix with Tables Q3 2023 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. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. 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 2022) and all total figures quoted are reported in CHF.[2] Biosimilar erosion to Avastin, Herceptin and Mabthera/Rituxan.[3] Products launched before 2015.[4] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Point of Care: diagnostics solutions in emergency rooms, medical practices or directly with patients.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics.Diabetes Care: integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics. 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 Nathalie AltermattPhone: +41 79 771 05 25 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Rebekka SchnellPhone: +41 79 205 27 03 Sileia UrechPhone: +41 79 935 81 48 Attachments 19102023_MR_RocheQ3_2023_en Communications appendix tables_Q3 2023_Sales (1)