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Basel, 22 July 2021

• 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).

Pharmaceuticals: major approvals; positive data in neuroscience and oncology
In addition to all the efforts in the fight against the pandemic, Roche has continued to develop innovative medicines for other serious diseases. In the second quarter, Roche reported a number of regulatory achievements:

In May, the European Commission approved Venclyxto⁵-based combinations for adults with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy, and Tecentriq as a first-line monotherapy treatment for people with a specific type of metastatic non-small cell lung cancer.

In June, the FDA granted priority review for Roche’s Port Delivery System (PDS) with ranibizumab for the treatment of neovascular or “wet” age-related macular degeneration. If approved, it would be the first and only eye implant with continuous drug delivery – an alternative to frequent eye injections.

Also in June, the European Commission approved Enspryng as the first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD) for both adults and adolescents. NMOSD is a rare autoimmune disease of the central nervous system that can cause permanent blindness, muscle weakness and paralysis.

Furthermore, Roche presented positive data in neurosciences and oncology:

Roche’s data across its growing neuroscience portfolio, presented at several medical congresses, demonstrates our continued commitment to developing breakthrough medicines for challenging neurological conditions. New data for Enspryng (NMOSD) and Evrysdi (spinal muscular atrophy, SMA) reinforced the efficacy and safety profile of both medicines, including early, very encouraging trial results for Evrysdi in pre-symptomatic infants under two months of age. Data for Ocrevus (relapsing and primary progressive multiple sclerosis, MS) showed consistent benefit on slowing disease progression in both forms of MS.

In addition, Roche presented new data from 19 approved and investigational medicines across 20 cancer types at the American Society of Clinical Oncology congress. One of the highlights was the highly promising immunotherapy data in early lung cancer. It showed that Tecentriq improved disease-free survival in people with resectable early-stage non-small cell lung cancer compared to best supportive care – a first in cancer immunotherapy.

The latest advances with immunotherapies in non-Hodgkin lymphoma were also encouraging: data from the emerging T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and the antibody-drug conjugate, Polivy, show the potential of these novel immunotherapeutic approaches for people with various types of blood cancer.

The outlook of Roche’s haematology franchise was strengthened further with new data from three pivotal phase III studies. These data, presented at the annual haematology congress EHA, reinforced the efficacy of Venclexta/Venclyxto combinations in hard-to-treat blood cancers.

Pharmaceuticals: major clinical and regulatory news flow up to mid-July 2021

Diagnostics: important launches in cardiovascular and oncology
Providing accurate and timely testing has never been more vital. Roche continues to invest heavily in diagnostic innovation to help meet the changing demands of healthcare systems beyond COVID-19.

In April, Roche launched new ways (claim extensions) to use their cardiovascular tests, empowering clinicians to improve screening, diagnosis and treatment of millions of people. These gold standard biomarkers have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks (Troponin T) and manage heart failure more effectively (NT-proBNP).

Also in April, Roche received US approval for the first companion diagnostic, VENTANA MMR RxDx Panel, to identify cancer patients best suited for treatment with a specific GSK immunotherapy.

Pharmaceuticals sales