Roche reports solid results in the first quarter of 2021

• Group sales increase 3%¹ at constant exchange rates (CER); 1% decline in Swiss francs, as a result of the appreciation of the Swiss franc
• Pharmaceuticals Division sales:
  • Continued strong growth of new medicines (+20%)
  • As expected, significant impact from biosimilars (CHF -1.6 billion)
  • Base effect from the strong first quarter 2020 (negative impact of the pandemic only since April 2020)
  • Overall, this results in a 9% decline in sales.
• Diagnostics Division sales:
  • All businesses contribute to very strong growth of 55%
• Roche’s contributions to the fight against the COVID-19 pandemic in the first quarter:
  • SARS-CoV-2 Rapid Antigen Test Nasal to quickly identify people with the highest risk to be infectious (using simple nasal swabs) receives CE mark and special approvals for self-testing in several countries
  • Research-use cobas SARS-CoV-2 Variant Set 1 Test launched to help monitor coronavirus mutations
  • Continued ramp-up of production capacity for COVID-19-related diagnostics and medicines
  • Partnership with Regeneron: Antibody combination casirivimab/imdevimab is now benefitting patients in an increasing number of countries, incl. the US, Germany, Italy, France and Switzerland
    Positive results of phase III studies in both COVID-19 prevention (reduction of symptomatic infections by 81%) and treatment (reduction of hospitalisation or death by 70%)
• Positive phase III results for Tecentriq in early lung cancer and for eye medicine faricimab
• Important approvals for medicines in the first quarter:
  • USA: Actemra/RoActemra for a rare lung disease; Xolair as a pre-filled syringe (eg, allergic asthma)
  • Europe: Evrysdi for spinal muscular atrophy
• Roche signs definitive merger agreement with GenMark Diagnostics
• Outlook for 2021 confirmed

Commenting on the Group’s performance in the first quarter, Roche CEO Severin Schwan said: “In 2021, Roche remains strongly committed to the fight against COVID-19. The uptake of our recently introduced diagnostic tests and medicines remains strong, while we continue to see the expected impact from biosimilars on sales of our established medicines. Our broad product pipeline keeps making good progress. I am particularly pleased about the highly encouraging study results of our immunotherapy Tecentriq in early lung cancer and of faricimab in ophthalmology. The upcoming acquisition of GenMark underlines our commitment to help control infectious diseases and antibiotic resistance. Based on the results of the first quarter of 2021, we confirm the outlook for the full year.”

Outlook confirmed for 2021

Despite the continued strong impact of biosimilars, 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 quarter of the year, Group sales rose 3% (-1% in CHF) to CHF 14.9 billion. The appreciation of the Swiss franc against many currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division decreased 9% to CHF 10.6 billion, mainly because of the continued biosimilars competition and the COVID-19 pandemic. As expected, the first quarter of 2021 was particularly challenging due to base effects, as the pandemic only started to have a significant business impact at Roche as of April 2020.

The impact of biosimilars on sales of the established cancer medicines MabThera/Rituxan, Avastin and Herceptin remained significant (combined sales reduction of CHF 1.6 billion), especially in the US.

Moreover, the pandemic continued to have a negative impact overall on the division’s sales, especially for medicines where regular visits to hospitals or health practices are needed (ie, for infusions). This was partly compensated by additional sales of medicines used to treat COVID-19 (Actemra/RoActemra +22%, mostly for treating patients with severe COVID-19-associated pneumonia², plus the recently launched antibody combination casirivimab/imdevimab).

The new medicines (launched since 2012³) grew by 20% (or CHF +880 million) and generated sales of CHF 5.2 billion. Overall, demand continued to grow encouragingly, though here too the impact of the lower number of doctor’s visits was clearly noticeable.

In the United States, sales decreased by 14%, as a result of the continued competition from biosimilars for the above mentioned cancer medicines (combined CHF -1.0 billion). This decline was partially compensated for by the new products (mainly Evrysdi, Ocrevus, Hemlibra and Tecentriq) and Actemra/RoActemra for COVID-19-associated pneumonia.

In Europe, sales decreased by 6%, as demand for the new products (including the antibody combination casirivimab/imdevimab) was only partly able to offset the impact of lower sales for the established cancer medicines (mainly Avastin) and impacts of the COVID-19 pandemic.

In Japan, sales decreased by 7%. This decline was mainly driven by the osteoporosis medicine Edirol and the competition from biosimilars. This was partially offset by sales of cancer immunotherapy Tecentriq.

In the International region, sales were stable. The impact of biosimilars was compensated by new products (Perjeta, Tecentriq and Ocrevus) and COVID-19 related Actemra/RoActemra sales.

The Diagnostics Division reported very strong sales growth of 55% to CHF 4.3 billion, mainly due to Roche’s comprehensive and growing portfolio of COVID-19 tests. The Point of Care and Molecular Lab businesses made the largest contributions (+281% and +86%, respectively) with COVID-19 testing.

Routine diagnostic testing, which was also greatly affected by the COVID-19 pandemic during 2020, recorded strong growth.

Additional product launches in the first quarter, such as a research-use PCR test to help monitor SARS-CoV-2 mutations, further strengthened Roche’s position as the world’s leading supplier of COVID-19 tests.

All regions reported very strong sales growth: EMEA⁴ and Asia-Pacific (both +62%), North America (+34%) and Latin America (+71%).

In March, Roche signed a definitive merger agreement with GenMark Diagnostics for approx. USD 1.8 billion⁵. Acquiring GenMark will give Roche access to a novel technology that can test a wide range of pathogens with one patient sample. It will broaden Roche’s molecular lab portfolio, including tests for COVID-19. The transaction is expected to close in the second quarter of 2021.

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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 twelfth 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 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 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.

All trademarks used or mentioned in this release are protected by law.

Additional information

- First Quarter 2021 Sales presentation: https://www.roche.com/irp210421-a.pdfhttps://assets.cwp.roche.com/imported/en/irp210421-a.pdf
- First Quarter 2021 Sales presentation with appendix: https://www.roche.com/irp210421.pdfhttps://assets.cwp.roche.com/imported/en/irp210421.pdf
- Annual Report: https://www.roche.com/investors/annualreport20.htm

Cautionary statement regarding forward-looking statements

This document 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 and comparisons to the previous year in this document are at constant exchange rates (CER: average 2020) and all total figures quoted are reported at CHF.
2. Actemra/RoActemra is not currently approved for this use.
3. Launched since 2012: Erivedge, Perjeta, Kadcyla, Gazyva/Gazyvaro, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi and antibody combination casirivimab/imdevimab.
4. EMEA: Europe, Middle East and Africa.
5. On a fully diluted basis.

Roche Investor Relations
Dr. Karl Mahler Phone: +41 61 68-78503 e-mail: karl.mahler@roche.com	Jon Kaspar Bayard Phone: +41 61 68-83894 e-mail: jon_kaspar.bayard@roche.com
Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com	Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com	Dr. Gerard Tobin Phone: +41 61 68-72942 e-mail: gerard.tobin@roche.com
Investor Relations North America
Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com	Dr. Lisa Tuomi Phone: +1 650 467 8737 e-mail: tuomi.lisa@gene.com