First quarter with 2% growth in Swiss francs, 7% at constant exchange rates

• Group sales increase 2% in Swiss francs and 7%¹ at constant exchange rates, driven by new products, more than compensating for impact of competition from biosimilars
• Pharmaceuticals Division sales up 7%, led by Tecentriq, Hemlibra, Ocrevus and Perjeta
• Diagnostics Division sales grow 5%, with molecular testing as main contributor
• Important approvals in the first quarter:
  • in China: Tecentriq for first-line combination therapy of extensive-stage small cell lung cancer
  • in the US: CINtec Plus Cytology test and cobas HPV test for use on cobas 6800/8800 Systems for cervical cancer screening
  • in the EU: Polivy in combination with bendamustine and MabThera/Rituxan, for the treatment of adult patients with a special form of B-cell lymphoma
  • in the EU: Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for adults with previously untreated chronic lymphocytic leukaemia
• Based on the current assessment of the COVID-19 impact the outlook for 2020 is confirmed

Impact of the COVID-19 pandemic

• Volatility in some markets has limited impact on business performance in the first quarter
• Global supply chain for medicines and tests remain intact
• FDA issued Emergency Use Authorization for the cobas SARS-CoV-2 test (coronavirus) for detection of infection with the virus; test also available in markets accepting the CE mark
• Production capacity for cobas SARS-CoV-2 test ramped up massively
• Clinical phase III study to evaluate the safety and efficacy of Actemra/RoActemra in severe COVID-19 pneumonia ongoing in several countries. Results are expected in early summer. Rapid increase of production capacity for Actemra/RoActemra
• Anti-SARS-CoV-2 serology test to detect antibodies in people exposed to SARS-CoV-2 in late stage development with availability aimed for early May. Monthly production is ramped up to high double-digit million tests by June with further scale up as fast as possible.

Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said: “The global coronavirus pandemic outbreak during the first quarter poses an unprecedented challenge in particular for healthcare systems worldwide. Roche made important contributions to the fight against COVID-19. In close collaboration with authorities we were able to make our cobas SARS-CoV-2 test available and to initiate a global phase III study of Actemra/RoActemra in COVID-19 pneumonia in record time. With healthcare needs remaining high, Roche’s business has so far proved to be resilient in this difficult environment. The uptake of our recently introduced medicines continues to be strong. Based on our current assessment, we 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 sales

In the first three months of the year, Group sales rose 7% to CHF 15.1 billion. Sales in the Pharmaceuticals Division increased 7% to CHF 12.3 billion. Key growth drivers were the cancer medicine Tecentriq, the haemophilia medicine Hemlibra, the multiple sclerosis medicine Ocrevus and the breast cancer medicine Perjeta. The strong uptake of newly introduced medicines generated sales of CHF 4.6 billion, including a growth of CHF 1.6 billion at constant exchange rates over 2019, more than offsetting the impact of the competition from biosimilars (CHF 857 million at constant exchange rates).²

In the US, the sales growth (+3%) was predominantly generated by recently launched medicines such as Ocrevus, Hemlibra and Tecentriq, partially offset by the competition from biosimilars.

In Europe, sales increased (+14%) as the strong demand for Tecentriq, Ocrevus, Perjeta, Hemlibra, Actemra/RoActemra and Kadcyla, was able to offset the impact of lower sales of Herceptin (-32%) and MabThera/Rituxan (-24%). The first biosimilar versions of Avastin are expected later this year.

In the International region, sales increased 16%, the main contributors were Perjeta, Ocrevus, Tamiflu and Alecensa. In China, the strong uptake of recently launched medicines Perjeta and Alecensa and higher sales of established products including Tamiflu and Rocephin offset the National Reimbursement Drug List price cut and COVID-19 impact for Herceptin, Avastin and MabThera/Rituxan.

Growth in Japan (+3%) was also driven by recently launched products Hemlibra, Tecentriq and Perjeta, despite considerable competition from biosimilars.

Diagnostics Division sales increased 5% to CHF 2.9 billion. The business area Molecular Diagnostics (+29%) was the main growth contributor, driven by molecular testing. Growth was reported in North America (+12%), EMEA³ (+7%), Latin America (+20%) and Japan (+14%). In the Asia-Pacific region (-11%) sales were strongly impacted by the COVID-19 pandemic shutdown in China. Overall, demand in North America, Europe and Latin America was less affected by COVID-19 in the first quarter due to the later onset of the pandemic in these regions. Routine testing decreased due to a decline in regular health checks while emergency and COVID-19 testing strongly increased.

Regulatory achievements in the first quarter

Regulators around the globe granted approvals for new Roche medicines, line extensions of existing medicines and new tests.

In China the National Medical Products Administration (NMPA) approved Tecentriq in combination with chemotherapy (carboplatin and etoposide) for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

The European Commission approved Polivy in combination with bendamustine and MabThera/Rituxan, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for a haematopoietic stem cell transplant.

The Commission also approved Venclexta/Venclyxto in combination with Gazyva/Gazyvaro for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.

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First Quarter Sales 2020 Audio Webcast and Conference Call

There will be an audio webcast and conference call for investors and analysts today, Wednesday, 22 April at 2:00 pm CEST. The live audio webcast can be accessed via http://ir.roche.com.

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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. In Europe: MabThera/Rituxan and Herceptin; in Japan: MabThera/Rituxan, Herceptin and Avastin; in the US: Herceptin, Avastin and MabThera/Rituxan
3. EMEA = Europe, Middle East and Africa