Basel, 15 October 2020
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 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
*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others
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.”
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.
Roche’s contributions to the fight against the COVID-19 pandemic
In September, the Elecsys Anti-SARS-CoV-2 S antibody test was launched for markets accepting the CE Mark. Roche has filed for Emergency Use Authorisation (EUA) from the FDA. The Elecsys Anti-SARS-CoV-2 S immunology test, which targets antibodies against the spike protein, can be used to quantitatively measure antibodies in people who have been exposed to SARS-CoV-2 and can play an important part in characterising a vaccine-induced immune response. The majority of current candidate vaccines aim to induce an antibody response against the spike protein of the virus.
In the same month, Roche received an EUA from the FDA for its cobas SARS-CoV-2 & Influenza A/B test for use on the cobas 6800/8800 Systems. This test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A and influenza B in patients suspected by their healthcare provider of having a respiratory viral infection; it is also available in markets accepting the CE Mark.
For urgent and emergency care settings, Roche also received EUA from the FDA in September for the cobas SARS CoV-2 & Influenza A/B test on the cobas Liat System, which provides results in 20 minutes.
Roche also launched the SARS-CoV-2 rapid antigen test in markets accepting the CE Mark and plans to submit files for an EUA with the FDA. The SARS-CoV-2 rapid antigen test is for use in point of care settings for symptomatic people. This can help healthcare professionals identify a SARS-CoV-2 infection in people suspected of carrying the virus with results typically ready in 15 minutes. In addition, it serves as a valuable initial screening test for individuals who have been exposed to SARS-CoV-2-infected patients or in a high-risk environment.
Roche also announced that it intends to launch a high-volume SARS-CoV-2 Antigen test as an aid in the diagnosis of SARS-CoV-2 infection. The test is planned to be made available at the end of 2020 for markets accepting the CE Mark. Roche also intends to file for EUA from the FDA. The test is performed by healthcare professionals and uses swab samples from patients with signs and symptoms suggestive of COVID-19, or people with either known or suspected exposure to SARS-CoV-2.
The portfolio of our recently developed SARS-CoV-2 tests as well as our existing diagnostics menu for critical care have become a significant factor in supporting patient management during the COVID-19 pandemic. Roche has already increased its overall production of tests fourfold over the usual volumes and has committed significant funds to continue expanding productions capacity for PCR tests over the coming year. Our investments are expected to result in more than 1,000 new jobs in the US and Europe.
The phase III Empacta study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care. The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. There was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo by day 28. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The trial was conducted in Brazil, Kenya, Mexico, Peru, South Africa and the USA.
In August, Roche and Regeneron joined forces in the fight against COVID-19 to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody cocktail. Regeneron has submitted a request to the FDA for an Emergency Use Authorization (EUA) for REGN-COV2. Initial data from the REGN-COV2 phase II portion of an ongoing study showed a reduction in viral load, an acceleration of symptom alleviation and a decrease in medical visits in non-hospitalised patients with COVID-19. Additional data from this study are expected by the end of 2020. We will be working with health authorities and global health institutions in a concerted, collective response, with the aim of achieving broad approvals. Drug launches, filings, pivotal phase III trial readouts and pivotal trial starts planned by the Roche Group are largely on track.
The Covacta study of Actemra/RoActemra did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19-associated pneumonia. In addition, the key secondary endpoints, which included the difference in patient mortality at week four, were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra. This study generated robust information which will help physicians make decisions about the treatment of patients with this disease.
Third Quarter Sales 2020 Webinar
There will be a webinar for investors and analysts today, Thursday, 15 October at 2:00 pm CEST. The live webinar can be accessed via http://ir.roche.com.
Roche 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.
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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 eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
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Cautionary statement regarding forward-looking statements
This Annual Report 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.
- Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2019).
- Launched since 2012: Erivedge, Perjeta, Kadcyla, Gazyva, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi
- EMEA = Europe, Middle East and Africa