First nine months of the year with 1% sales growth at constant exchange rates, significant impact of COVID-19 pandemic

Group sales increase 1%¹ at constant exchange rates and decline 5% in Swiss francs as a result of continued appreciation of the Swiss franc against most currenciesImpact of COVID-19 pandemic: Following strong sales growth in the first quarter (+7%) and COVID-19 related decline in the second quarter (-4%) sales stabilise in the third quarter (+1%) supported by continued strong sales of new medicines and COVID-19 testsOutlook for 2020 confirmedPharmaceuticals Division sales decrease 1%, newly launched medicines (+35%)², including Tecentriq, Ocrevus, Hemlibra and Perjeta, largely compensating for the impact of COVID-19 and competition from biosimilars Diagnostics Division sales grow 9%, with COVID-19 testing as the main contributorApprovals for medicines in the third quarter:In the US: Enspryng for the treatment of a rare autoimmune disease of the CNS (neuromyelitis optica spectrum disorder); Evrysdi (risdiplam) for the treatment of spinal muscular atrophy; Gavreto (pralsetinib) for the treatment of a specific form of non-small cell lung cancer (NSCLC); Tecentriq plus Cotellic and Zelboraf for the treatment of a specific form of melanomaIn Europe: Rozlytrek for the treatment of adults with a specific form of NSCLC and for adults and paediatric patients 12 years of age and older with solid tumours expressing a specific gene fusionInitiation of 11 phase 3 studies in the third quarterDiagnostic launches in the third quarter in the US: Ventana HER2 Dual ISH DNA Probe Cocktail assay to aid in the assessment of Herceptin therapies; cobas EBV test for Epstein-Barr virus and cobas BKV test for BK virus in transplant patients; cobas HIV-1/HIV-2 qualitative test; Elecsys HIV Duo Immunoassay; expanded use for CINtec PLUS Cytology test to aid clinicians in cervical cancer screeningCommenting on the Group’s sales in the first nine months, Roche CEO Severin Schwan said: “Roche is at the forefront of the fight against COVID-19 with a growing portfolio of diagnostics solutions, the development of new medicines and a number of partnerships across the industry. With the recent launch of the rapid antigen test, we further strengthened our position as a leading supplier of COVID-19 tests. At the same time, we continue to deliver solutions for patients suffering from other severe diseases. I am particularly pleased about the FDA approvals in the third quarter for three new medicines: Enspryng and Evrysdi for rare diseases, and the cancer medicine Gavreto. After the pandemic-related decline in the second quarter, sales stabilised in the third quarter due to continued strong demand for our new medicines and COVID-19 tests. Based on our current assessment, we confirm the outlook for the full-year.”Launch of new diagnostic products for COVID-19: SARS-CoV-2 rapid antigen test in the EU; cobas SARS-CoV-2 & influenza A/B test for use on the cobas 6800/8800 System; cobas SARS-CoV-2 & influenza A/B test on the cobas Liat System in urgent and emergency care settings; Elecsys Anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark; adding up to a total of 13 new diagnostic solutions developed in 2020Production capacity for SARS-CoV-2 tests ramped up significantlyResults phase III Empacta study: Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19-associated pneumoniaPartnership of Roche and Regeneron on new antiviral antibody cocktail: Initial data showed REGN-COV2 antibody cocktail reduced viral levels and improved symptoms in non-hospitalised COVID-19 patients. Regeneron has submitted request to the US FDA for an Emergency Use Authorization (EUA) for REGN-COV2Outlook confirmed for 2020
Based on the current assessment of the COVID-19 impact, 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.
Regulatory achievements in the third quarter
Regulators around the globe granted approvals for new Roche medicines, line extensions of existing medicines and new tests.
Diagnostics – key launches in the third quarter
In addition to the new COVID-19 portfolio, Roche received FDA approval for the Ventana HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin therapy. HER2 – human epidermal growth factor receptor 2 – is an important biomarker sometimes found in breast cancers. Its detection and inhibition can help healthcare professionals manage this aggressive cancer more effectively. This new assay is designed to be completed within the same day, enabling clinicians to get results back faster than with other common methods of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialised fluorescence microscope.Key pharmaceutical products
Avastin (-22%). For advanced colorectal, breast, lung, kidney, cervical and ovarian cancer, and relapsed glioblastoma (a type of brain tumour). Sales were impacted by the biosimilar competition in the US, Europe and Japan.
In the first nine months 2020, COVID-19 and emergency testing strongly increased while routine testing decreased as a result of continued declining or delayed regular health checks and medical appointments. Nevertheless, Roche’s broad, diversified test portfolio and its large number of instruments installed worldwide provided for a strong sales growth.References
[1] Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2019).
[2] Launched since 2012: Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi
[3] EMEA = Europe, Middle East and Africa
[4] recently launched, no growth figures availableAttachment15102020_MR_Q3_EN