[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good half-year results
Roche reported an 8% increase in Group sales at constant exchange rates for H1 2021, totaling CHF 30.7 billion. The Pharmaceuticals Division experienced a 3% sales decline, offset by a 51% surge in Diagnostics, driven by COVID-19 tests. Key highlights include positive study results for Tecentriq in lung cancer and new EU approvals for Venclyxto and Enspryng. Despite continued biosimilar challenges, new medicines recorded 30% growth. Roche maintains its 2021 outlook, expecting low to mid-single-digit sales growth. Core EPS rose by 6%, affirming the company's strong market position amid recovery signs in the Pharma Division.
- Group sales increased by 8% at constant exchange rates, totaling CHF 30.7 billion.
- Positive study results for Tecentriq in early lung cancer bolster Roche's oncology portfolio.
- New medicines launched since 2012 experienced a significant 30% growth, contributing over 50% to total pharmaceutical sales.
- Diagnostics Division sales soared 51%, largely due to high demand for COVID-19 tests.
- Pharmaceuticals Division sales declined by 3%, largely impacted by biosimilar competition.
- US sales decreased by 8%, significantly affected by biosimilars for key cancer treatments.
- The ongoing impact from biosimilars resulted in a sales loss of CHF 2.8 billion in the Pharmaceuticals Division.
Basel, 22 July 2021
- Group sales up
8% 1 at constant exchange rates (CER);5% in Swiss francs - Pharmaceuticals Division sales decline
3% ; sales grow4% in the second quarter, following a first-quarter decrease of9% ; 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 up6% - 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
Key figures | CHF millions | % change | ||
January - June 2021 | 2021 | 2020 | At CER1 | In CHF |
Group sales | 30,713 | 29,281 | 8 | 5 |
Pharmaceuticals Division | 21,671 | 23,202 | -3 | -7 |
Diagnostics Division | 9,042 | 6,079 | 51 | 49 |
Core operating profit | 11,652 | 11,766 | 4 | -1 |
Core EPS - diluted (CHF) | 10.56 | 10.44 | 6 | 1 |
IFRS net income | 8,216 | 8,465 | 2 | -3 |
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
Sales in the Pharmaceuticals Division were CHF 22 billion, a decrease of
The new medicines (launched since 20122) continued their strong growth (+
In the United States, sales decreased by
Sales in Europe grew by
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
The Diagnostics Division achieved very strong sales growth of
The division recorded high sales growth in all regions: Europe, Middle East and Africa +
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
Compound | Indication | Milestone | |
Regulatory | Xofluza | Influenza: Healthy people; high-risk people; post exposure | EU approval |
Evrysdi | Spinal muscular atrophy (SMA) type 1/2/3 | EU approval | |
faricimab | Diabetic macular oedema/neovascular age-related macular degeneration (nAMD) | US/EU joint filing | |
Tecentriq | First-line PDL1+ non-small cell lung cancer (NSCLC) | EU approval | |
Venclexta + azacitidine | Acute myeloid leukaemia | EU approval | |
Phase III / pivotal readouts | faricimab | nAMD | Ph III TENAYA/LUCERNE |
casirivimab/imdevimab | SARS-CoV-2 outpatient | Ph III study 2067 | |
casirivimab/imdevimab | SARS-CoV-2 post-exposure prophylaxis | Ph III study 2069 | |
Tecentriq | Adjuvant NSCLC | Ph III IMpower010 | |
Evrysdi | SMA type 1/2/3 switching study | Ph II JEWELFISH |
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
Sales | CHF millions | As % of sales | % change | |||
January - June 2021 | 2021 | 2020 | 2021 | 2020 | At CER | In CHF |
Pharmaceuticals Division | 21,671 | 23,202 | 100.0 | 100.0 | -3 | -7 |
United States | 10,802 | 12,464 | 49.8 | 53.7 | -8 | -13 |
Europe | 4,485 | 4,190 | 20.7 | 18.1 | 4 | 7 |
Japan | 1,808 | 1,908 | 8.3 | 8.2 | 0 | -5 |
International* | 4,576 | 4,640 | 21.2 | 20.0 | 2 | -1 |
*Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others | ||||||
|
Top-selling pharmaceuticals | Total | United States | Europe | Japan | International* | |||||
CHFm | % | CHFm | % | CHFm | % | CHFm | % | CHFm | % | |
Ocrevus | 2,438 | 23 | 1'849 | 18 | 422 | 38 | - | - | 167 | 60 |
Perjeta | 1,968 | 5 | 703 | -3 | 578 | -1 | 132 | -6 | 555 | 28 |
Avastin | 1,645 | -40 | 530 | -47 | 257 | -69 | 330 | -4 | 528 | -12 |
Actemra/RoActemra | 1,642 | 17 | 689 | 6 | 456 | 16 | 182 | 6 | 315 | 63 |
Tecentriq | 1,599 | 29 | 811 | 16 | 339 | 17 | 257 | 84 | 192 | 68 |
Herceptin | 1,396 | -35 | 348 | -56 | 277 | -25 | 43 | -40 | 728 | -19 |
Hemlibra | 1,393 | 45 | 837 | 34 | 292 | 95 | 166 | 16 | 98 | 138 |
MabThera/Rituxan | 1,379 | -41 | 855 | -46 | 134 | -35 | 20 | -35 | 370 | -27 |
Kadcyla | 959 | 19 | 401 | 6 | 336 | 27 | 60 | 56 | 162 | 31 |
Xolair | 887 | -1 | 887 | -1 | - | - | - | - | - | - |
* Asia–Pacific, EEMEA (Eastern Europe, Middle East and Africa), Latin America, Canada, others |
Pharmaceuticals: established products
Avastin (CHF 1.6 billion -
Actemra/RoActemra (CHF 1.6 billion, +
Herceptin (CHF 1.4 billion, -
MabThera/Rituxan (CHF 1.4 billion, -
Xolair (CHF 887 million, -
Lucentis (CHF 665 million, -
Pharmaceuticals: medicines launched since 2012
Ocrevus (first approved in 2017; CHF 2.4 billion, +
Perjeta (first approved in 2012; CHF 2 billion, +
Tecentriq (first approved in 2016; CHF 1.6 billion, +
Hemlibra (first approved in 2017; CHF 1.4 billion, +
Kadcyla (first approved in 2013; CHF 959 million, +
Alecensa (first approved in 2015; CHF 631 million, +
Ronapreve (first approved in 2021; FDA EUA in 2020 for Regeneron; CHF 595 million*). Antibody combination casirivimab/imdevimab for the treatment of recently diagnosed high-risk patients with mild to moderate COVID-19. Roche and Regeneron are collaborating on developing and manufacturing the medicine; Roche is responsible for distribution in Europe and other countries outside the US. There was a strong uptake, mainly in Germany, India, Italy and France.
Esbriet (first approved in 2014; CHF 526 million, -
Gazyva/Gazyvaro (first approved in 2013; CHF 324 million, +
Evrysdi (first approved in 2020; CHF 243 million*). Spinal muscular atrophy (SMA) in adults and children two months of age and older. Evrysdi helps infants to survive without permanent ventilation; the first and only medicine for SMA that can be taken at home. The new SMA medicine continued to show a strong uptake, mainly in the US and Russia.
Erivedge (first approved in 2012; CHF 127 million, -
Phesgo (first approved in 2020; CHF 96 million*). Early and metastatic HER2-positive breast cancer (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection). Offers faster administration in just minutes, compared to hours with standard intravenous administration.
Polivy (first approved in 2019; CHF 94 million, +
Enspryng (first approved in 2020; CHF 39 million*). Rare autoimmune disease of the central nervous system (neuromyelitis optica spectrum disorder; NMOSD); first subcutaneous NMOSD treatment that can be self-administered at home. The medicine continues to show a good uptake, despite COVID-19 restrictions having some impact on potential new patients.
Rozlytrek (first approved in 2019; CHF 22 million, +
Diagnostics sales
Sales | CHF millions | As % of sales | % change | |||
January - June 2021 | 2021 | 2020 | 2021 | 2020 | At CER | In CHF |
Diagnostics Division | 9,042 | 6,079 | 100.0 | 100.0 | 51 | 49 |
Customer Areas | ||||||
Core Lab | 3,726 | 2,821 | 41.2 | 46.4 | 34 | 32 |
Molecular Lab | 2,216 | 1,558 | 24.5 | 25.6 | 45 | 42 |
Point of Care | 1,616 | 360 | 17.9 | 5.9 | 349 | 349 |
Diabetes Care | 894 | 832 | 9.9 | 13.7 | 10 | 7 |
Pathology Lab | 590 | 508 | 6.5 | 8.4 | 20 | 16 |
Regions | ||||||
Europe, Middle East, Africa | 4,144 | 2,408 | 45.8 | 39.5 | 70 | 72 |
North America | 2,055 | 1,740 | 22.7 | 28.8 | 25 | 18 |
Asia–Pacific | 2,293 | 1,588 | 25.4 | 26.1 | 44 | 44 |
Latin America | 550 | 343 | 6.1 | 5.6 | 77 | 60 |
Core Lab. Focuses on central labs; provides diagnostics solutions in the areas of immunoassays, clinical chemistry and custom biotech. Sales increased by
Molecular Lab. Focuses on molecular labs; provides diagnostics solutions for the detection and monitoring of pathogens, donor screening, sexual health and genomics. Sales grew by
Point of Care. Focuses on diagnostics solutions at the point of care, e.g. in emergency rooms, medical practices or directly with patients; includes SARS-CoV-2 rapid tests, blood gas and electrolyte tests. Significant sales growth of
Diabetes Care. Focuses on integrated personalised diabetes management for people with diabetes and healthcare professionals. Sales increased by
Pathology Lab. Focuses on pathology labs; provides diagnostics solutions for tissue biopsies and companion diagnostics. Sales increased by
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).
[5] Venclexta/Venclexto is being developed by AbbVie and Roche.
* recently launched, no growth figures available
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