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 mutations -- Continued ramp-up of production capacity for COVID-19-related diagnostics and medicines -- Partnership 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 faricimab -- Important 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 Diagnostics -- Outlook 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." Sales CHF millions As % of sales % change -------------------- ------------------ ---------------- January -- March At In 2021 2021 2020 2021 2020 CER CHF --------------------- --------- --------- -------- -------- ------ -------- Group sales 14,930 15,143 100.0 100.0 3 -1 Pharmaceuticals Division 10,600 12,262 71.0 81.0 -9 -14 United States 5,292 6,616 35.4 43.7 -14 -20 Europe 2,175 2,264 14.6 15.0 -6 -4 Japan 852 948 5.7 6.3 -7 -10 International* 2,281 2,434 15.3 16.0 0 -6 Diagnostics Division 4,330 2,881 29.0 19.0 55 50 --------------------- --------- --------- -------- -------- ------ -------- *Asia-Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others Outlook confirmed for 2021 Despite 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 results In 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 pneumonia(2) , plus the recently launched antibody combination casirivimab/imdevimab). The new medicines (launched since 2012(3) ) 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: EMEA(4) 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 billion(5) . 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 2021 Roche 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: Diagnostics Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. In February, Roche obtained the CE mark(6) 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
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