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

• Group sales increase 1%¹ at constant exchange rates and decline 4% in Swiss francs as a result of continued appreciation of the Swiss franc against most currencies
• COVID-19 pandemic has a negative impact on sales during the second quarter; since June sales are recovering
• Pharmaceuticals Division sales up 1%, driven by newly launched medicines (+37%),² including Tecentriq, Hemlibra, Ocrevus and Perjeta, compensating for the impact of competition from biosimilars
• Diagnostics Division sales grow 3%, with COVID-19 testing as the main contributor; routine testing declining as COVID-19 causes delays of patients visiting physicians
• Approvals for medicines in the second quarter:
  • in the US: Tecentriq as a first-line monotherapy for certain people with metastatic non-small cell lung cancer; Tecentriq in combination with Avastin for people with the most common form of liver cancer; Phesgo for HER2-positive breast cancer
  • in Japan, Canada and Switzerland: Enspryng (satralizumab) for the treatment of a rare neurodegenerative disease (neuromyelitis optica spectrum disorder)
  • in Europe: Ocrevus with shorter infusion time
• Completion of phase III trial enrolment for pivotal studies in Alzheimer’s and Huntington’s disease and start of four important phase III studies in oncology
• Diagnostic launches in the second quarter: several tests for COVID-19 diagnosis; cobas prime, a pre-analytical system for automation in molecular labs; digital pathology algorithms for non-small cell lung cancer and breast cancer
• Core earnings per share up 2%
• On IFRS basis, net income increases 3%
• Outlook for 2020 confirmed

Roche’s contributions to the fight against the COVID-19 pandemic in the second quarter:

• Launches of several new diagnostic tools for COVID-19, including the Elecsys Anti-SARS-CoV-2 test, Roche v-TAC digital algorithm and the Elecsys IL-6 test
• Production capacity for SARS-CoV-2 tests ramped up significantly
• Six different medicines in 28 clinical trials for COVID-19 infections
• Read-out of Covacta study with Actemra/RoActemra expected soon

Commenting on the Group’s performance in the first half of the year, Roche CEO Severin Schwan said: “The corona pandemic continues to pose an enormous challenge worldwide. I am grateful that, in close collaboration with health authorities, we have been able to make a number of SARS-CoV-2 tests available and start several global Actemra/RoActemra phase III studies in COVID-19 pneumonia. At the same time, Roche’s regular business was significantly impacted by the pandemic in the second quarter. But we now see clear signs of recovery. Furthermore, the uptake of our recently introduced medicines and diagnostic tests continues to be strong. Based on our current assessment of the impact of the pandemic, we can confirm the outlook for the full year.”

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.

Group results

In the first half of 2020, Group sales rose 1% to CHF 29.3 billion and core EPS grew 2%, ahead of sales. IFRS net income increased 3% at constant exchange rates, due to the strong underlying core results. As a result of the continued appreciation of the Swiss franc against most currencies, the IFRS net income expressed in Swiss francs decreased 5% to CHF 8.5 billion.

Sales in the Pharmaceuticals Division increased 1% to CHF 23.2 billion. The COVID-19 pandemic had an overall negative impact on the division’s sales, especially in May. Hospitalisations and out-patient visits decreased, which particularly impacted sales of Ocrevus, Hemlibra, Lucentis and MabThera/Rituxan. Key growth drivers were the cancer medicine Tecentriq, the haemophilia medicine Hemlibra, the multiple sclerosis medicine Ocrevus, Actemra/RoActemra in immunology and Perjeta in breast cancer. The new medicines (+37%) generated sales of CHF 8.9 billion and grew by CHF 2.5 billion at constant exchange rates over 2019, more than offsetting the impact of the competition from biosimilars (CHF 2.1 billion at constant exchange rates).³

Within the Roche Group’s sales growth of 1% in the first half of 2020, there was 7% year-on-year growth in the first quarter and 4% decline in the second quarter. Especially in May, Roche’s business was impacted by the COVID-19 pandemic.

In the US, overall sales decreased 4%. While sales of Hemlibra, Ocrevus, Tecentriq and Actemra/RoActemra increased, competition from biosimilars for Herceptin, Avastin and MabThera/Rituxan impacted this growth as expected. Hemlibra sales increased 80%, resulting from the ongoing rollout in the US. Ocrevus sales increased by 19% and were driven by both new and returning patient demand. Sales of both Hemlibra and Ocrevus were partly impacted by COVID-19 effects. Tecentriq sales increased by 52%, driven by the growth in the new indications ES-SCLC and triple-negative breast cancer. In the US, as well as in other countries, an increased use of Actemra/RoActemra in patients with severe COVID-19 pneumonia can be observed as countries included it in their treatment guidelines. Actemra/RoActemra is not currently approved for this use; Roche is conducting several phase III clinical studies in severe COVID-19 pneumonia. Results from the Covacta study are expected soon.

In Europe, sales increased (+5%) as the strong demand for Tecentriq, Ocrevus, Hemlibra, Kadcyla, Perjeta and Actemra/RoActemra was able to offset the impact of lower sales of Herceptin (-33%) and MabThera/Rituxan (-34%). The first biosimilar versions of Avastin could come to market in Europe in the second half of 2020.

In the International region (+11%), growth was mostly driven by Russia and China. Growth in China resulted from a strong uptake of Perjeta and Alecensa, partially offset by the National Reimbursement Drug List price cut and COVID-19 impact for Herceptin, MabThera/Rituxan and Avastin.

Sales decreased in Japan 2%, resulting from considerable competition from biosimilars, generics and government price cuts. This decline was partially compensated by recently launched products including Tecentriq, Hemlibra and Perjeta.

Diagnostics Division sales increased 3% to CHF 6.1 billion. The business area Molecular Diagnostics (+61%) was the main growth contributor. Sales of the recently developed cobas SARS-CoV-2 PCR tests could offset the negative impact of the COVID-19 pandemic on products for routine diagnosis. Growth was reported in North America (+13%), EMEA⁴ (+5%), Latin America (+6%) and Japan (+1%). In the Asia-Pacific region (-9%), sales were strongly impacted by the COVID-19 pandemic shutdown in China. Overall, demand was impacted by COVID-19 in all regions in the second quarter. Routine testing decreased significantly due to a decline in regular health checks while emergency and SARS-Co-V-2 testing increased significantly.

The core operating profit increased 2% in the Pharmaceuticals Division and 9% in the Diagnostics Division.

Roche’s response to the COVID-19 pandemic

Ever since the early phase of the COVID-19 pandemic, we have been partnering with healthcare providers, laboratories, authorities and organisations to provide patients with the tests, treatments and care they need.

The portfolio of our recently developed SARS-Co-V-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 is working closely with healthcare providers around the world, and has significantly increased production to provide tests globally.

To date no major manufacturing supply chain issues have been identified and the Group’s planned drug launches, filings, pivotal phase III trial readouts and pivotal trial starts are largely on track. The Group is continuously monitoring the situation.

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About Roche

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.

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 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).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 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.

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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.

References

1. Unless otherwise stated, all growth rates in this document are at constant exchange rates (CER: average 2019).
2. Launched since 2012: Alecensa, Cotellic, Erivedge, Esbriet, Gazyva, Hemlibra, Kadcyla, Ocrevus, Perjeta, Polivy, Rozlytrek, Tecentriq and Xofluza
3. In Europe: MabThera/Rituxan and Herceptin; in Japan: MabThera/Rituxan, Herceptin and Avastin; in the US: Herceptin, Avastin and MabThera/Rituxan
4. EMEA = Europe, Middle East and Africa