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Roche reports solid results in the first quarter of 2021
Basel, 21 April 2021 Group sales increase 3%1 at constant exchange rates (CER); 1% decline in Swiss francs, as a result of the appreciation of the Swiss franc Pharmaceuticals Division sales: Continued strong growth of new medicines (+20%)As expected, significant impact from biosimilars (CHF -1.6 billion)Base effect from the strong first quarter 2020 (negative impact of the pandemic only since April 2020)Overall, this results in a 9% decline in sales. Diagnostics Division sales: All businesses contribute to very strong growth of 55% Roche’s contributions to the fight against the COVID-19 pandemic in the first quarter: SARS-CoV-2 Rapid Antigen Test Nasal to quickly identify people with the highest risk to be infectious (using simple nasal swabs) receives CE mark and special approvals for self-testing in several countries Research-use cobas SARS-CoV-2 Variant Set 1 Test launched to help monitor coronavirus mutationsContinued ramp-up of production capacity for COVID-19-related diagnostics and medicinesPartnership with Regeneron: Antibody combination casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. the US, Germany, Italy, France and Switzerland Positive results of phase III studies in both COVID-19 prevention (reduction of symptomatic infections by 81%) and treatment (reduction of hospitalisation or death by 70%) Positive phase III results for Tecentriq in early lung cancer and for eye medicine faricimabImportant approvals for medicines in the first quarter: USA: Actemra/RoActemra for a rare lung disease; Xolair as a pre-filled syringe (eg, allergic asthma)Europe: Evrysdi for spinal muscular atrophy Roche signs definitive merger agreement with GenMark DiagnosticsOutlook for 2021 confirmed Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said:“In 2021, Roche remains strongly committed to the fight against COVID-19. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines. Our broad product pipeline keeps making good progress. I am particularly pleased about the highly encouraging study results of our immunotherapy Tecentriq in early lung cancer and of faricimab in ophthalmology. The upcoming acquisition of GenMark underlines our commitment to help control infectious diseases and antibiotic resistance. Based on the results of the first quarter of 2021, we confirm the outlook for the full year.” SalesCHF millionsAs % of sales% changeJanuary – March 20212021202020212020At CERIn CHFGroup sales14,93015,143100.0100.03-1 Pharmaceuticals Division10,60012,26271.081.0-9-14United States5,2926,61635.443.7-14-20Europe2,1752,26414.615.0-6-4Japan8529485.76.3-7-10International*2,2812,43415.316.00-6 Diagnostics Division4,3302,88129.019.05550*Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others Outlook confirmed for 2021Despite the continued strong impact of biosimilars, sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further.Group resultsIn the first quarter of the year, Group sales rose 3% (-1% in CHF) to CHF 14.9 billion. The appreciation of the Swiss franc against many currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, mainly because of the continued biosimilars competition and the COVID-19 pandemic. As expected, the first quarter of 2021 was particularly challenging due to base effects, as the pandemic only started to have a significant business impact at Roche as of April 2020.The impact of biosimilars on sales of the established cancer medicines MabThera/Rituxan, Avastin and Herceptin remained significant (combined sales reduction of CHF 1.6 billion), especially in the US.Moreover, the pandemic continued to have a negative impact overall on the division’s sales, especially for medicines where regular visits to hospitals or health practices are needed (ie, for infusions). This was partly compensated by additional sales of medicines used to treat COVID-19 (Actemra/RoActemra +22%, mostly for treating patients with severe COVID-19-associated pneumonia2, plus the recently launched antibody combination casirivimab/imdevimab).The new medicines (launched since 20123) grew by 20% (or CHF +880 million) and generated sales of CHF 5.2 billion. Overall, demand continued to grow encouragingly, though here too the impact of the lower number of doctor’s visits was clearly noticeable.In the United States, sales decreased by 14%, as a result of the continued competition from biosimilars for the above mentioned cancer medicines (combined CHF -1.0 billion). This decline was partially compensated for by the new products (mainly Evrysdi, Ocrevus, Hemlibra and Tecentriq) and Actemra/RoActemra for COVID-19-associated pneumonia.In Europe, sales decreased by 6%, as demand for the new products (including the antibody combination casirivimab/imdevimab) was only partly able to offset the impact of lower sales for the established cancer medicines (mainly Avastin) and impacts of the COVID-19 pandemic.In Japan, sales decreased by 7%. This decline was mainly driven by the osteoporosis medicine Edirol and the competition from biosimilars. This was partially offset by sales of cancer immunotherapy Tecentriq.In the International region, sales were stable. The impact of biosimilars was compensated by new products (Perjeta, Tecentriq and Ocrevus) and COVID-19 related Actemra/RoActemra sales.The Diagnostics Division reported very strong sales growth of 55% to CHF 4.3 billion, mainly due to Roche’s comprehensive and growing portfolio of COVID-19 tests. The Point of Care and Molecular Lab businesses made the largest contributions (+281% and +86%, respectively) with COVID-19 testing.Routine diagnostic testing, which was also greatly affected by the COVID-19 pandemic during 2020, recorded strong growth.Additional product launches in the first quarter, such as a research-use PCR test to help monitor SARS-CoV-2 mutations, further strengthened Roche’s position as the world’s leading supplier of COVID-19 tests.All regions reported very strong sales growth: EMEA4 and Asia-Pacific (both +62%), North America (+34%) and Latin America (+71%).In March, Roche signed a definitive merger agreement with GenMark Diagnostics for approx. USD 1.8 billion5. Acquiring GenMark will give Roche access to a novel technology that can test a wide range of pathogens with one patient sample. It will broaden Roche’s molecular lab portfolio, including tests for COVID-19. The transaction is expected to close in the second quarter of 2021.COVID-19: Roche’s response to the pandemic in the first quarter 2021Roche is making a significant effort globally to assist the fight against COVID-19. We now have 18 diagnostic solutions that help to detect and diagnose the infection and thereby help to prevent the spread of the pandemic, and we are providing digital support to healthcare systems. Roche also continues to explore the potential of its investigational molecules and existing portfolio of medicines.In addition, Roche entered into a number of partnerships, including with Gilead, Regeneron and Atea, to develop, manufacture and/or distribute molecules that potentially can both treat and prevent COVID-19.COVID-19: DiagnosticsReliable, high-quality testing is essential to help healthcare systems overcome this pandemic. In February, Roche obtained the CE mark6 for its new SARS-CoV-2 Rapid Antigen Test Nasal (for professional use). It collects the sample from the front area of the nose instead of the nasopharynx, resulting in a more comfortable and faster testing procedure, with results ready after only 15 minutes.Shortly after, the test received special approval in several European countries for patient self-testing at home. It can quickly identify people with the highest potential to be infectious so they can take immediate action. Regular self-testing at home can be one element of national testing strategies to reduce pressure on healthcare systems.Viruses naturally evolve over time. Roche’s research-use solution, the cobas SARS-CoV-2 Variant Set 1 Test, provides laboratories with a fast and efficient way to investigate these variants found in infected individuals. The test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission and is performed on widely available high-throughput systems.Periodic assessments against emerging variants have shown that Roche’s current diagnostic tests for detecting active SARS-CoV-2 infections remain accurate and effective.COVID-19: Diagnostic solutions launched in the first quarter of 2021 Solution UsageAvailability Launch dateSARS-CoV-2 Rapid Antigen Test NasalProfessional use. For nasal testing of a specific SARS-CoV-2 antigen; results ready after only 15 minutes. CE markFebSARS-CoV-2 Rapid Antigen Test NasalHome use. For self-testing using a simple nasal swab; results ready after only 15 minutes. Several countries in EuropeFebcobas SARS-CoV-2 Variant Set 1 TestTo detect key spike mutations in virus variants associated with increased human-to-human transmissionResearch use onlyMarchNAVIFY Pass Digital solution for providers to communicate SARS-CoV-2 Rapid Antigen test results to a mobile app US and CE mark (selected countries)March COVID-19: PharmaceuticalsThe antibody combination (casirivimab/imdevimab) co-developed with Regeneron is now available not only to patients in the US, but also in a growing number of countries worldwide, including Germany, Italy, France, Denmark, Switzerland, Canada and Israel.In February, the European regulatory authorities (CHMP) issued a scientific opinion supporting the use of casirivimab/imdevimab for the treatment of patients with mild-to-moderate COVID-19 who are at high risk of progressing to severe COVID-19.In March, Roche confirmed positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalised patients. The phase III data showed that the antibody combination reduced hospitalisation or death by 70% in non-hospitalised patients with COVID-19. It is the only monoclonal antibody treatment to retain potency against key emerging variants7. In April, other strong phase III data confirmed the potential dual value of casirivimab/imdevimab to reduce household COVID-19 infections (prevention) and to decrease the disease burden in those who do become infected. The trial showed that the subcutaneous administration of casirivimab/imdevimab reduced the risk of symptomatic infections by 81% in those who were not infected when they entered the trial. In addition, Roche is exploring the potential of its investigational molecules and existing portfolio: For example, Roche has conducted three global phase III clinical trials investigating the safety and efficacy of our anti-inflammation medicine Actemra/RoActemra in COVID-19-associated pneumonia (COVACTA, EMPACTA and REMDACTA).In March, Roche announced that one of the studies, REMDACTA, investigating Actemra/RoActemra plus an antiviral, Veklury, did not reduce hospital stays for patients with severe COVID-19 pneumonia, compared to those getting just Veklury. Roche will submit the results to a peer-reviewed journal.Roche continues to believe that the totality of data suggests a potential role for Actemra/RoActemra in treating certain patients with COVID-19, and will further evaluate data from the REMDACTA, COVACTA and EMPACTA studies as well as other studies on this medicine and discuss these data with health authorities.Pipeline development in the first quarter of 2021Despite all efforts in the fight against the pandemic, Roche has continued to develop innovative medicines and diagnostics for other disease areas. Regulators around the globe granted approvals for new Roche medicines, line extensions of existing medicines and diagnostics solutions.Pharmaceuticals: Regulatory achievementsIn March, Roche reported a number of regulatory achievements: The US FDA approved Actemra/RoActemra subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This approval provides a much-needed new treatment option for people living with this rare, debilitating disease.The European Commission approved Evrysdi, the first and only at-home spinal muscular atrophy (SMA) treatment with proven efficacy in adults and infants two months and older. SMA is a leading genetic cause of death in infants. In two pivotal clinical studies, Evrysdi showed event-free survival and motor milestone improvements never previously achieved in the natural history of the disease.In addition, the European regulatory authorities recommended approval of Tecentriq as a first-line (initial) monotherapy treatment for people with a certain type of metastatic non-small cell lung cancer (NSCLC). This is a significant step forward in bringing a new chemotherapy-free treatment with flexible treatment schedules to people in Europe with certain types of lung cancer.In April, Roche received US approval for Xolair as a pre-filled syringe across all US indications, ie, allergic asthma. Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the pandemic.Pharmaceuticals: Key development milestones Regulatory filings and product launches for 2021 as well as pivotal trial read-outs and pivotal starts in 2021 are largely on track.In February, Roche presented positive results from four phase III studies of its investigational injectable eye medicine faricimab for diabetic macular oedema and neovascular age-related macular degeneration, two common causes of blindness. Faricimab’s potential to extend time between treatments up to four months may benefit those patients who struggle to keep up with the regular eye injections needed to preserve their vision.Treating lung cancer early may help prevent the disease from returning and therefore provide the best opportunity for a cure. In March, Roche announced highly encouraging data for Tecentriq: With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning.Advances in medicine and pharmaceuticals carry inherent risks – also in March, Roche decided to discontinue dosing in a phase III study of tominersen, an investigational medicine for Huntington’s disease (HD). Roche will share preliminary data from this study at the upcoming CHDI Foundation’s 16th Annual HD Therapeutics Conference and is committed to undertaking and sharing further analyses of tominersen data to inform on programme next steps and learn more about this complex disease.Pharmaceuticals: Key development milestones in the first quarter of 2021 (in addition to COVID-19) Study: compoundIndicationOutcomePhase III IMpower010: TecentriqResectable early-stage lung cancer Improves disease-free survival, compared to best supportive care Phase III SUNFISH part 2 (two-year data): EvrysdiSpinal muscular atrophy (SMA) Continues to demonstrate improvement or maintenance of motor function in people aged 2 to 25 with SMA type 2 or type 3 Phase III YOSEMITE and RHINE / TENAYA and LUCERNE: FaricimabDiabetic macular oedema (DME) / neovascular age-related macular degeneration (nAMD)Across four studies, approximately half of people receiving faricimab could be treated every four months in the first year Diagnostics: Key launches and development milestones (in addition to COVID-19) Providing accurate and timely testing has never been more vital. Roche continues to invest heavily in laboratory innovation to help meet the changing demands of healthcare systems. In March, Roche launched the new cobas pure integrated solutions analyser in countries accepting the CE mark. This new compact analyser combines three technologies on a single platform helping to simplify daily operations in labs with limited space and resources. It reduces the hands-on maintenance time of technicians to just 5 minutes per day, which is 80% less than previous-generation systems.Shortly after, Roche launched eight new high-throughput configurations for cobas pro integrated solutions – Roche’s latest analyser designed for larger labs (CE mark). As a result, this analyser can deliver up to 4,400 tests per hour, doubling its previous testing capacity, thus offering labs greater flexibility to ramp up their testing capacity to adapt to evolving testing needs.The latest additions to Roche’s comprehensive diagnostics portfolio are the Elecsys Epstein-Barr Virus (EBV) immunoassay panel and the Elecsys Anti-p53 immunoassay, both launched in countries accepting the CE Mark: The panel consists of three specific EBV tests and accurately identifies the EBV infection stage from a single blood sample, which means less confirmatory testing and, potentially, faster diagnosis for patients. The Anti-p53 immunoassay helps physicians to diagnose several prevalent cancers in patients. Furthermore, the FDA granted Breakthrough Device Designation for the Elecsys GDF-15 assay as a companion diagnostic in cancer treatment. It is intended to measure growth differentiation factor-15 (GDF-15) in cachectic patients who are to be treated with an investigational medicine from our partner Pfizer.Pharmaceuticals sales SalesCHF millionsAs % of sales% changeJanuary – March 20212021202020212020At CERIn CHFPharmaceuticals Division10,60012,262100.0100.0-9-14United States5,2926,61649.954.0-14-20Europe2,1752,26420.418.4-6-4Japan8529488.07.7-7-10International*2,2812,43421.719.90-6 *Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others Pharmaceuticals: Established productsAvastin (CHF 863 million, -40%). Advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, relapsed glioblastoma (a type of brain tumour) and liver cancer in combination with Tecentriq. Sales were strongly impacted by the biosimilar competition, mainly in Europe and the US.Actemra/RoActemra (CHF 779 million, +22%). Rheumatoid arthritis, forms of juvenile idiopathic arthritis and giant cell arteritis as well as CAR T cell-induced severe or life-threatening cytokine release syndrome. A number of countries included this medicine in their treatment guidelines for severe COVID-19-associated pneumonia. Actemra/RoActemra is not currently approved for this use; various clinical studies have been carried out and the results made available to healthcare authorities. Sales were driven by the International region, with a slight slowdown in other markets.Herceptin (CHF 755 million, -35%). HER2-positive breast cancer and HER2-positive metastatic gastric cancer. Sales were impacted by biosimilars across all regions.MabThera/Rituxan (CHF 705 million, -46%). Forms of blood cancer, rheumatoid arthritis and certain types of vasculitis. The sales decline was driven by all regions, due to the biosimilar erosion as well as COVID-19 pandemic restrictions.Xolair (CHF 409 million, -6%, US only). Chronic idiopathic urticaria (CIU) and allergic asthma; self-injection (home use). Sales grew in the CIU indication. Xolair remains the market leader in the larger allergic asthma indication.Lucentis (CHF 337 million, -7%, US only). Eye conditions, including ‘wet’ age-related macular degeneration. Pharmaceuticals: Medicines launched since 2012Ocrevus (first approved in 2017; CHF 1.2 billion, +16%). Relapsing and primary progressive forms of multiple sclerosis; shorter 2-hour infusion. The demand for this treatment in both indications remained strong, while the COVID-19 pandemic continues to have a certain negative impact. In the US, growth was driven both by new and returning patients, with a higher proportion of sales coming from returning patients. Perjeta (first approved in 2012; CHF 988 million, +2%). HER2-positive breast cancer. In the International region (+23%), patient demand for this cancer medicine remained strong. Tecentriq (first approved in 2016; CHF 775 million, +26%). Cancer immunotherapy for various types of cancer (either alone or in combinations), ie, certain types of lung, bladder, breast and liver cancer. Continued strong sales growth reported by all regions. Hemlibra (first approved in 2017; CHF 661 million, +33%). Haemophilia A with and without factor VIII inhibitors; only prophylactic treatment that can be administered subcutaneously once weekly, every two or every four weeks. Sales continued to show a strong uptake across all regions (especially in the US and Europe); COVID-19 restrictions still had some impact on potential new patients. Kadcyla (first approved in 2013; CHF 478 million, +17%). HER2-positive breast cancer. The sales growth was driven by the usage of Kadcyla in the early breast cancer setting. Sales benefited from patients switching to the new standard of treatment. Alecensa (first approved in 2015; CHF 298 million, +14%). ALK-positive non-small cell lung cancer. The demand for this cancer medicine was particularly strong in the International region (+44%). Esbriet (first approved in 2014; CHF 256 million, -8%). Idiopathic pulmonary fibrosis (IPF). Sales declined or were stable across all regions. Casirivimab and imdevimab antibody combination (FDA EUA in 2020, filed by our partner Regeneron; CHF 166 million*). For the treatment of recently diagnosed high-risk patients with mild to moderate COVID-19. Roche and Regeneron are collaborating on developing and manufacturing the medicine; Roche is responsible for distribution in Europe and other countries outside the US. There were orders from multiple countries. Gazyva/Gazyvaro (first approved in 2013; CHF 155 million, -2%). Chronic lymphocytic leukaemia, rituximab-refractory follicular lymphoma and previously untreated advanced follicular lymphoma. Evrysdi (first approved in 2020; CHF 80 million*). Spinal muscular atrophy (SMA) in adults and children two months of age and older. Evrysdi helps infants to survive without permanent ventilation; first and only medicine for SMA that can be taken at home. The new SMA medicine showed a very strong uptake in the US. Erivedge (first approved in 2012; CHF 60 million, -13%). Advanced basal cell carcinoma. Polivy (first approved in 2019; CHF 43 million, +18%). Relapsed or refractory diffuse large B-cell lymphoma; part of combination therapy; fixed-duration treatment option for people with this aggressive form of lymphoma. The strong uptake in the European market more than compensates for the decline in the US. Phesgo (first approved in 2020; CHF 29 million*). Early and metastatic HER2-positive breast cancer (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection). Offers faster administration in just minutes, compared to hours with standard intravenous administration. Sales showed a positive uptake in the US, and further strong growth is anticipated in Europe. Enspryng (first approved in 2020; CHF 14 million*). Rare autoimmune disease of the central nervous system (neuromyelitis optica spectrum disorder; NMOSD); first subcutaneous NMOSD treatment that can be self-administered at home. The medicine showed a good uptake, despite COVID-19 restrictions having some impact on potential new patients. Rozlytrek (first approved in 2019; CHF 9 million, +187%). Specific form of non-small cell lung cancer (NSCLC); solid tumours expressing a specific gene fusion; ROS1-positive, advanced NSCLC. Strong sales growth in the US. Xofluza (first approved in 2018; CHF 0 million, -100%). Acute, uncomplicated influenza, for people with high risk of developing flu-related complications; prevention of influenza following contact with infected person. No sales, as no flu season occurred, probably due to COVID-19 restrictions. * recently launched, no growth figures available Top-selling pharmaceuticals TotalUnited StatesEuropeJapanInternational*CHFm%CHFm%CHFm%CHFm%CHFm%Ocrevus1,22616914921737--9577Perjeta9882360-2301-364-1126323Avastin863-40287-48138-68161-8277-4Actemra/RoActemra77922305102391284-2151134Tecentriq775263951316814120829284Herceptin755-35191-57146-2522-43396-16MabThera/Rituxan705-46426-5369-4510-37200-23Hemlibra661333982113671791148214Kadcyla4781720051672427548428Xolair409-6409-6------ * Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America,Canada, others Diagnostics sales SalesCHF millionsAs % of sales% changeJanuary – March 20212021202020212020At CERIn CHFDiagnostics Division4,3302,881100.0100.05550Customer Areas Core Lab1,7651,38240.847.93128Molecular Lab1,10761425.621.38680Diabetes Care46042510.614.8138Pathology Lab2822706.59.494Point of Care71619016.56.6281277Regions Europe, Middle East, Africa1,9671,21545.542.26262North America1,05183524.229.03426Asia-Pacific1,04565024.122.56261Latin America2671816.26.37148 Sales of the customer area Core Lab increased by 31%, driven by its immunodiagnostics business (+40%). Asia-Pacific (+65%) and the EMEA region (+17%) were the main growth drivers. Molecular Lab sales increased by 86%. The very strong sales growth was driven by the areas virology (predominantly SARS-CoV-2 tests, such as Roche’s high-throughput PCR tests), mainly in the EMEA region and the US. Diabetes Care sales increased by 13%. The increase was driven by its blood glucose monitoring business (such as the Accu-Chek Guide system), offsetting the decline in insulin delivery systems. Demand for digital diabetes management solutions (such as the RocheDiabetes Care Platform) remained strong. Pathology Lab sales increased by 9%. This was mainly due to growth in companion diagnostics and advanced staining instruments sales. Point of Care sales grew by 281%, mainly driven by strong sales of Roche’s new point-of-care COVID-19 testing portfolio (such as our SARS-CoV-2 Rapid Antigen test). About RocheRoche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. 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. 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 Annual Report, 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 2020 or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average 2020) and all total figures quoted are reported at CHF.[2] Actemra/RoActemra is not currently approved for this use. [3] Launched since 2012: Erivedge, Perjeta, Kadcyla, Gazyva/Gazyvaro, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi and antibody combination casirivimab/imdevimab. [4] EMEA: Europe, Middle East and Africa. [5] On a fully diluted basis.[6] Available in countries accepting the CE mark.[7] Based on recently updated Emergency Use Authorization (EUA) guidance from the FDA. Roche Group Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Dr. Nicolas DunantPhone: +41 61 687 05 17Patrick BarthPhone: +41 61 688 44 86Dr. Daniel Grotzky Phone: +41 61 688 31 10Karsten KleinePhone: +41 61 682 28 31Nina MählitzPhone: +41 79 327 54 74Nathalie MeetzPhone: +41 61 687 43 05 Dr. Barbara von SchnurbeinPhone: +41 61 687 89 67 Attachments Communication appendix tables Q1 2021 21042021_MR_Q1_en
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