[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good half-year results

• Group sales up 8%¹ at constant exchange rates (CER); 5% in Swiss francs
• Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars
• Diagnostics Division sales grow 51% due to high demand for COVID-19 tests and strong momentum in routine testing
• IFRS net income increases by 2% (-3% in Swiss francs), while core earnings per share up 6%
• Highlights in the second quarter:
  • Pipeline: Positive study results for immunotherapy Tecentriq in early lung cancer; encouraging data strengthen Roche’s portfolio in neurosciences and hard-to-treat blood cancers
  • EU approvals: Tecentriq (specific type of metastatic non-small cell lung cancer), Venclyxto-based combinations (acute myeloid leukaemia) and Enspryng (neuromyelitis optica spectrum disorder, a rare autoimmune disease of the CNS)
  • GenMark Diagnostics: Acquisition, completed in April, broadens Roche’s molecular lab portfolio and reinforces our commitment to fight infectious diseases and antibiotic resistance
  • COVID-19: Additional positive study results for antibody combination Ronapreve (co-developed with Regeneron) and AT-527 (co-developed with Atea); Japan becomes first country to approve Ronapreve for the treatment of mild to moderate COVID-19; FDA Emergency Use Authorization for Actemra/RoActemra; launch of further tests reinforces Roche’s position as a global leader in COVID-19 diagnostics
• Outlook for 2021 confirmed

Commenting on the Group’s performance in the first six months, Roche CEO Severin Schwan said: “We have achieved good results in the first half, primarily thanks to the demand for our new medicines and COVID-19 tests. The Pharma Division began to grow again in the second quarter. The base diagnostics business shows strong momentum. As expected, demand for COVID-19 tests peaked in the second quarter. I’m particularly excited about the significant progress we made in our product pipeline, including very promising study results for Tecentriq in early-stage lung cancer, as well as additional positive data for Evrysdi in spinal muscular atrophy and for COVID-19 medicines. Based on the good results of the first half 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 half of the year, Group sales rose 8% (5% in CHF) to CHF 31 billion. IFRS net income increased 2% (-3% in CHF), while core earnings per share up by 6%. The appreciation of the Swiss franc against most currencies had a negative impact on the results expressed in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division were CHF 22 billion, a decrease of 3%. However, while sales in the first quarter were still strongly affected by COVID-19 (-9%), the second quarter showed signs of recovery in some regions (+4%). The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 billion.

The new medicines (launched since 2012²) continued their strong growth (+30%, or +CHF 2.6 billion). In the first six months, they generated sales of over CHF 11 billion, thus already contributing more than 50% to the division’s total sales.

In the United States, sales decreased by 8%, due to the launches of biosimilars for the cancer medicines MabThera/Rituxan, Avastin and Herceptin (combined -49% or CHF 1.7 billion) and the pandemic. This decline was partially compensated for by the new medicines – mainly Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (cancer immunotherapy). Here too, business is showing signs of recovery: after -14% in the first quarter, sales in the second quarter were stable, i.e. at the previous year’s level.

Sales in Europe grew by 4%, with new product sales more than compensating for the impact from biosimilars and the pandemic. Ronapreve, the antibody combination against COVID-19, was the key growth driver, mainly in Germany, Italy and France.

In Japan, sales were stable. Growth of recently launched medicines, such as Tecentriq and Enspryng, was offset by the impact from biosimilars and government price cuts.

Sales in the International region grew by 2%. Growth in China (+3%) was mainly due to strong sales of Perjeta, Alecensa, Tecentriq and Herceptin, partly offset by biosimilar competition for Avastin and MabThera/Rituxan. Excluding China, sales increased by 1%, mainly due to orders for Ronapreve in India, again partially offset by the impact from biosimilars, mainly in Canada and Brazil.

The Diagnostics Division achieved very strong sales growth of 51% to CHF 9 billion. The base business (i.e. routine diagnostics), which was heavily impacted by the pandemic in 2020, grew strongly: +17% in the first quarter and +31% in the second quarter. Roche’s industry-leading portfolio of COVID-19 tests contributed total sales of CHF 2.5 billion (CHF 0.7 billion in 2020); the demand for COVID-19 tests is likely to decrease in the second half of 2021.

The division recorded high sales growth in all regions: Europe, Middle East and Africa +70%, Asia-Pacific +44%, North America +25% and Latin America +77%.

In April, Roche acquired the US company GenMark Diagnostics for USD 1.9 billion. GenMark’s novel technology detects a wide range of pathogens from a single patient sample. It broadens Roche’s molecular lab portfolio, and reinforces our commitment to help control infectious diseases and antibiotic resistance.

Roche’s response to the COVID-19 pandemic

Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, more treatment options are still needed. In the second quarter, Roche and/or its partners shared positive news:

• Antibody combination Ronapreve (co-developed with Regeneron): Preliminary phase III data from a University of Oxford-led trial demonstrated that the antibody combination casirivimab/imdevimab reduced the risk of death when given to patients hospitalised with severe COVID-19 who had not mounted a natural antibody response of their own. In July, Japan became the first country to approve Ronapreve for the treatment of patients with mild to moderate COVID-19.
• AT-527 (co-developed with Atea): Interim results from a phase II trial indicated rapid and sustained antiviral activity against SARS-CoV-2 in hospitalised COVID-19 patients. AT-527 continues to be evaluated for the treatment and prevention of COVID-19.
• Actemra/RoActemra:³ Roche’s intravenous anti-inflammation medicine received FDA Emergency Use Authorization (EUA) for the treatment of severe COVID-19 in hospitalised adults and children.
• Manufacturing: Roche is currently ramping up its production capacity for AT-527, which requires a complex manufacturing process, as much as possible. For Actemra, Roche has already increased its own production capacity significantly and has been working with external manufacturers on transferring its technologies to increase the global supply further.

Roche has also reinforced its position as a world-leading supplier of COVID-19 diagnostics. In June, the SARS-CoV-2 Antigen Self Test Nasal obtained the CE mark,⁴ and the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System was granted first FDA EUA for PCR testing of both symptomatic and asymptomatic individuals at the point of care (with results within 20 minutes).

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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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

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.

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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 prior year in this document are at constant exchange rates (CER: average 2020) and all total figures quoted are reported in CHF.
2. Launched since 2012: Erivedge, Perjeta, Kadcyla, Gazyva/Gazyvaro, Esbriet, Cotellic, Alecensa, Tecentriq, Ocrevus, Hemlibra, Xofluza, Polivy, Rozlytrek, Phesgo, Enspryng, Evrysdi and Ronapreve (casirivimab/imdevimab).
3. Actemra/RoActemra is currently not approved for this use.
4. An early version has already been available in a number of European countries since February 2021 (local special approval pathways).