The FINANCIAL — Commenting 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.”
- Group sales increase 1% at constant exchange rates and decline 5% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies
- Impact 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 tests
- Outlook for 2020 confirmed
- Pharmaceuticals 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 contributor
- Approvals 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 melanoma
- In 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 fusion
- Initiation of 11 phase 3 studies in the third quarter
- Diagnostic 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 screening
Roche’s contributions to the fight against the COVID-19 pandemic in the third quarter:
- 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 2020
- Production capacity for SARS-CoV-2 tests ramped up significantly
- Results phase III Empacta study: Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19-associated pneumonia
- Partnership 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-COV2
Outlook 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.
In the first nine months of 2020, Group sales increased 1% to CHF 44.0 billion.
Sales in the Pharmaceuticals Division decreased 1% to CHF 34.3 billion. Sales grew strongly in the first quarter (+7%). As a result of COVID-19, they decreased in the second quarter (-6%) and since summer first signals of recovery are seen (-4% in the third quarter). Key growth drivers were the cancer medicine Tecentriq, the multiple sclerosis medicine Ocrevus, the haemophilia medicine Hemlibra, Actemra/RoActemra in immunology and Perjeta in breast cancer.
With a strong growth of 35% the new medicines generated sales of CHF 13.7 billion and grew by CHF 3.7 billion at constant exchange rates over 2019, more than offsetting the impact of the competition from biosimilars (sales reduction CHF 3.5 billion at constant exchange rates).
In the US, overall sales decreased 4%. While sales of Ocrevus, Hemlibra, Tecentriq, Actemra/RoActemra and Kadcyla increased, the competition from biosimilars for Herceptin, MabThera/Rituxan and Avastin affected total growth as expected. Ocrevus sales increased by 23% and were driven by both new and returning patient demand but partly impacted by COVID-19 effects. Hemlibra sales increased 68%, resulting from the ongoing rollout in the US. Tecentriq sales increased by 46%, driven by the launch in unresectable hepatocellular carcinoma (HCC) as well as the growth in the new indications extensive stage small cell lung cancer (ES-SCLC) and metastatic triple-negative breast cancer.
In Europe, sales increased 4% as the strong demand for Tecentriq, Ocrevus, Hemlibra, Kadcyla and Perjeta was able to offset the impact of lower sales of Herceptin (-32%), Avastin (-16%) and MabThera/Rituxan (-32%). The first biosimilar versions of Avastin were introduced in Europe in the third quarter of 2020.
In the International region (+6%), growth was mostly driven by Perjeta, Actemra/RoActemra, Alecensa, Tecentriq and Ocrevus, partially offset by the impact of the National Reimbursement Drug List update in China and COVID-19.
Sales decreased in Japan (-6%) as a result of the considerable competition from biosimilars, generics, COVID-19 and government price cuts. This decline was partially compensated by recently launched products including Tecentriq and Hemlibra.
The Diagnostics Division recorded very strong sales growth of 9% to CHF 9.7 billion, with particularly strong growth of 18% in the third quarter. After a 5% increase in the first quarter, momentum slowed to 2% growth in the second quarter as a result of the pandemic. The overall very strong sales growth is primarily due to the industry-leading portfolio of new COVID-19 tests. The Molecular Diagnostics business made the largest contribution (+77%) with PCR tests for COVID-19. Sales of diagnostic solutions for SARS-CoV-2 developed only this year clearly exceeded COVID-19 related declines in routine diagnostics sales. Additional product launches in the third quarter, including the SARS-CoV-2 antigen rapid test, further strengthened Roche’s position as the world’s leading supplier of COVID-19 tests.
Growth was reported in North America (+22%), EMEA3 (+9%), Latin America (+12%) and Japan (+5%). In the Asia-Pacific region (-4%), sales were heavily impacted by the pandemic, especially in China. Overall, demand was impacted by COVID-19 in all regions since the second quarter. Routine testing decreased significantly due to a decline in regular health checks while emergency and SARS-CoV-2 testing increased significantly.