[Ad hoc announcement pursuant to Art. 53 LR] Roche achieves good results in the first six months of 2022
Roche reported a 5% increase in group sales, reaching CHF 32.3 billion in the first half of 2022, driven by strong demand for new medicines and diagnostics. The Pharmaceuticals Division grew 3%, with significant contributions from products like Hemlibra and Ocrevus. The Diagnostics Division saw an 11% rise, bolstered by COVID-19 test sales. Net income rose by 12% to CHF 9.2 billion. Roche confirmed its outlook for 2022, anticipating stable sales growth while facing challenges from declining COVID-19 medicine sales and biosimilar competition, projecting a potential CHF 2.5 billion revenue loss from biosimilars.
- 5% increase in group sales to CHF 32.3 billion.
- Pharmaceuticals Division sales grew 3%, with new medicines contributing CHF 1.5 billion.
- Diagnostics Division sales rose 11%, driven by COVID-19 test revenues of CHF 3.1 billion.
- 12% increase in net income to CHF 9.2 billion.
- Core earnings per share up 11% to CHF 11.76.
- Anticipated CHF 2 billion decline in COVID-19 medicine and diagnostics sales.
- Projected CHF 2.5 billion revenue loss due to biosimilars competition.
- Sales in Europe decreased by 4%, primarily due to lower COVID-19 product sales.
Basel, 21 July 2022
- Group sales up
5% 1 at constant exchange rates (CER) and5% in Swiss francs - Pharmaceuticals Division sales increase
3% ; continued strong demand for new medicines to treat severe diseases; as expected, the impact of biosimilars slows down further - Diagnostics Division sales grow
11% ; ongoing strong base business; demand for COVID-19 tests is expected to decline in the second half of the year - IFRS net income increases by
12% (12% in Swiss francs), while core earnings per share are up11% - Highlights in the second quarter:
- EU approvals of Polivy (first-line treatment for aggressive form of blood cancer), Lunsumio (follicular lymphoma) and Tecentriq (early-stage lung cancer); EU marketing authorisation application submitted for glofitamab (blood cancer)
- US approval of Evrysdi (babies under two months of age with spinal muscular atrophy) and US priority review for Lunsumio
- Launch of innovative platforms and systems for tissue-based cancer diagnostics, of HPV self-sampling solution and monkeypox virus test kits
- Outlook for 2022 confirmed
Roche CEO Severin Schwan: “We achieved good results in the first half of the year, thanks to the continued strong demand for our diagnostics base business and our new medicines to treat haemophilia, cancer and neurological disorders. Thanks to the ongoing renewal of our portfolio, we continue to grow despite biosimilars, whose impact declined further as expected. Based on our current assessment, we confirm the outlook for the full year.”
Key figures | CHF millions | % change | ||
January - June 2022 | 2022 | 2021 | CER | CHF |
Group sales | 32,295 | 30,713 | 5 | 5 |
Pharmaceuticals Division | 22,347 | 21,671 | 3 | 3 |
Diagnostics Division | 9,948 | 9,042 | 11 | 10 |
Core operating profit | 12,668 | 11,652 | 9 | 9 |
Core EPS (in CHF) - diluted | 11.76 | 10.56 | 11 | 11 |
IFRS net income | 9,161 | 8,216 | 12 | 12 |
Outlook confirmed for 2022
Sales are expected to be stable or grow in the low-single digits (at constant exchange rates). Core earnings per share are targeted to grow in the low- to mid-single digit range (at constant exchange rates), including the accretive effect of the 2021 share repurchase. Roche expects to further increase its dividend in Swiss francs.
Roche anticipates sales of COVID-19 medicines and diagnostics to decrease by approximately CHF 2 billion to around CHF 5 billion, and sales losses due to biosimilars in the current year to be roughly CHF 2.5 billion. Excluding those effects, Group sales are expected to grow in the high-single digit range.
Group results
In the first half of the year, the Roche Group achieved sales growth of
IFRS net income increased
Pharmaceuticals Division sales increased by
Hemlibra (haemophilia), Ocrevus (multiple sclerosis), Evrysdi (spinal muscular atrophy), Phesgo (breast cancer) and Tecentriq (cancer) alone contributed an additional CHF 1.5 billion in new sales.
As expected, the impact of competition from biosimilars for the established cancer medicines Avastin, Herceptin and MabThera/Rituxan slowed down further (combined CHF 1.0 billion of sales reduction).
Sales in the United States grew by
Sales in Europe decreased by
Sales in Japan increased by
Sales in the International region grew by
Diagnostics Division sales increased by
Roche’s industry-leading COVID-19 portfolio generated sales of CHF 3.1 billion in the first six months of the year (compared to CHF 2.5 billion during the same period last year). The demand for COVID-19 tests is likely to decrease in the third quarter of 2022.
Sales in the Asia-Pacific and North America regions increased by
Access to healthcare
In May, Roche renewed its commitment to the World Federation of Hemophilia (WFH) Humanitarian Aid Program until the end of 2028: Roche will continue to provide its prophylactic medicine Hemlibra to treat people with haemophilia A in developing countries.
Also in May, Roche entered into a partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostic infrastructure. This new partnership aims to help millions of previously undiagnosed people with tuberculosis and HIV get diagnosed and eventually treated.
Pharmaceuticals: key approvals and development milestones in the 2nd quarter of 2022
Oncology
Oncology remains Roche’s primary area of research and development. The company has one of the industry’s broadest and most comprehensive oncology pipelines and portfolios.
Blood cancers are challenging to treat at all stages. In the second quarter, Roche achieved a number of milestones in this area:
- The European Commission (EC) approved the Polivy combination therapy for people with previously untreated diffuse large B-cell lymphoma (DLBCL). This is the first therapy in more than 20 years to significantly improve outcomes in this aggressive form of blood cancer.
- In addition, the EC approved Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma (FL), and shortly after, the FDA granted priority review for this innovative medicine. Lunsumio represents a new type of immunotherapy that is a chemotherapy-free, fixed-duration treatment option.
- Glofitamab is a potential first-in-class bispecific antibody that may improve the lives of people with an aggressive form of blood cancer (diffuse large B-cell lymphoma; DLBCL). Roche submitted glofitamab for approval to the European Medicines Agency.
Approximately half of all people with early-stage non-small cell lung cancer (eNSCLC) develop recurrence after surgery, which in some cases is no longer curable. Treating this cancer at an earlier stage offers thus the best chance to prevent recurrence. In June, the EC approved Tecentriq in eNSCLC. It is currently the first and only cancer immunotherapy available for the adjuvant treatment of certain people with eNSCLC in Europe.
Roche reported initial results from the first interim analysis of the SKYSCRAPER-01 study in PD-L1-high metastatic non-small cell lung cancer. Tiragolumab plus Tecentriq did not meet its co-primary endpoint of progression-free survival. The study will continue for the co-primary endpoint of overall survival to mature, which is a decisive factor in this setting.
Neurosciences
Roche has approved medicines and investigational compounds for the treatment of multiple sclerosis, spinal muscular atrophy (SMA), neuromyelitis optica spectrum disorders, Myasthenia Gravis, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy.
SMA affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. In May, the FDA approved Evrysdi for use in babies under two months of age with SMA. This approval is particularly important, as early treatment of SMA, before symptoms start to appear, can help babies achieve motor milestones. In addition, Roche announced new three-year data, reinforcing the long-term efficacy and safety of Evrysdi in infants with symptomatic type 1 SMA.
In June, Roche announced study results of crenezumab. The study evaluated the potential of crenezumab to slow or prevent Alzheimer’s disease in cognitively unimpaired people who carry a specific genetic mutation which causes early-onset Alzheimer’s disease. While the treatment did not demonstrate a statistically significant clinical benefit, Roche is confident that the rich data collected will enhance the broader scientific community’s knowledge of Alzheimer’s disease as well as support future research efforts in the field.
Pharmaceuticals: key development milestones in the second quarter of 2022
Compound | Indication | Milestone | |
Regulatory | Polivy combination | Previously untreated diffuse large B-cell lymphoma (DLBCL) | EU approval |
Lunsumio (mosunetuzumab) | Relapsed or refractory follicular lymphoma (FL) | EU approval | |
Glofitamab | Relapsed or refractory (R/R) DLBCL | Submitted for EU approval | |
Evrysdi | For babies under two months of age with spinal muscular atrophy (SMA) | FDA approval | |
Phase III, pivotal and other key readouts | Evrysdi | SMA type 1 (infants): long-term efficacy and safety | FIREFISH study (new three-year data) |
Giredestrant | ER-positive, HER2-negative untreated early breast cancer | Phase II coopERA study (final analysis) | |
Venclexta/Venclyxto plus Gazyva/Gazyvaro | Previously untreated chronic lymphocytic leukaemia | Phase III CLL14 study (new five-year data) | |
| Gazyva/Gazyvaro plus chemotherapy | Previously untreated FL | Phase III GALLIUM study (final analysis) |
Crenezumab | Alzheimer’s disease | Phase II API ADAD (Colombia) trial: co-primary endpoints not met | |
Hemlibra | Mild to moderate haemophilia A | Phase III HAVEN 6 study | |
Vabysmo | Neovascular age-related macular degeneration (AMD) | Phase III TENAYA and LUCERNE studies (new two-year data ) | |
Perjeta | HER2-positive breast cancer: invasive disease-free survival | Phase III APHINITY study (new eight-year data) |
Diagnostics: key milestones in the second quarter of 2022
Diagnostic tools are crucial for responding to and ultimately controlling emerging public health challenges. In May, Roche and its subsidiary TIB Molbiol swiftly developed three unique PCR LightMix Modular Virus test kits that detect the monkeypox virus and aid in tracking its epidemiologic spread.
Furthermore, Roche received FDA Emergency Use Authorization (EUA) for its cobas SARS-CoV-2 Duo, the first PCR test to detect the COVID-19 virus and simultaneously measure the viral load in an individual. It helps healthcare providers with contact tracing, patient triage, therapy and monitoring.
Every year, over 600,000 women worldwide are diagnosed with cervical cancer, and more than half die from the disease. Cervical cancer is caused by infection with the human papillomavirus (HPV) and is preventable with timely diagnosis. In June, Roche launched a self-sampling solution for the cobas HPV test in countries accepting the CE mark. Enabling women to self-collect their own specimens for HPV testing is a critical step in the fight against cervical cancer.
Also in June, Roche announced the CE launch of the VENTANA DP 600. This high-capacity slide scanner produces high-resolution, digital images of stained tissue samples that help diagnose cancer. It also enables better and more personalised healthcare: in combination with our AI image analysis algorithms, this solution can help ensure that each patient receives the most effective treatment plan possible.
In addition, Roche launched the BenchMark ULTRA PLUS, an advanced tissue staining platform. This system enables pathologists to provide quick and accurate results that help inform patient treatment options.
Around 60 million people worldwide live with chronic hepatitis C (HCV) infection, but only one in five is aware of it. In July, Roche launched Elecsys HCV Duo, the first commercially available diagnostic test for the simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status.
Pharmaceuticals sales
Sales | CHF millions | As % of sales | % change | |||||||||||||
January - June 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF | ||||||||||
Pharmaceuticals Division | 22,347 | 21,671 | 100.0 | 100.0 | 3 | 3 | ||||||||||
United States | 11,363 | 10,802 | 50.8 | 49.8 | 1 | 5 | ||||||||||
Europe | 4,104 | 4,485 | 18.4 | 20.7 | -4 | -8 | ||||||||||
Japan | 2,202 | 1,808 | 9.9 | 8.3 | 34 | 22 | ||||||||||
International* | 4,678 | 4,576 | 20.9 | 21.2 | 2 | 2 | ||||||||||
*Asia-Pacific, CEETRIS (Central Eastern Europe, Turkey, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others | ||||||||||||||||
Top-selling pharmaceuticals | Total | United States | Europe | Japan | International* | |||||||||||
CHFm | % | CHFm | % | CHFm | % | CHFm | % | CHFm | % | |||||||
Ocrevus | 2,910 | 17 | 2,140 | 11 | 539 | 34 | - | - | 231 | 43 | ||||||
Perjeta | 2,061 | 5 | 740 | 1 | 457 | -17 | 120 | -1 | 744 | 34 | ||||||
Hemlibra | 1,826 | 30 | 1,098 | 26 | 360 | 30 | 180 | 19 | 188 | 89 | ||||||
Tecentriq | 1,758 | 11 | 951 | 13 | 383 | 19 | 218 | -7 | 206 | 9 | ||||||
Actemra/RoActemra | 1,455 | -10 | 664 | -7 | 420 | -3 | 174 | 4 | 197 | -37 | ||||||
Herceptin | 1,179 | -16 | 263 | -27 | 233 | -11 | 28 | -28 | 655 | -11 | ||||||
Avastin | 1,142 | -29 | 342 | -38 | 116 | -53 | 263 | -13 | 421 | -20 | ||||||
MabThera/Rituxan | 1,117 | -21 | 691 | -22 | 105 | -17 | 17 | -8 | 304 | -19 | ||||||
Kadcyla | 1,074 | 14 | 415 | -1 | 350 | 10 | 68 | 23 | 241 | 52 | ||||||
Xolair | 1,025 | 11 | 1,025 | 11 | - | - | - | - | - | - |
* Asia-Pacific, CEETRIS (Central Eastern Europe, Turkey, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Pharmaceuticals sales: selected top-selling and new medicines
Ocrevus (first approved in 2017; CHF 2.9 billion, +
Perjeta (first approved in 2012; CHF 2.1 billion, +
Hemlibra (first approved in 2017; CHF 1.8 billion, +
Tecentriq (first approved in 2016; CHF 1.8 billion, +
Actemra/RoActemra2 (CHF 1.5 billion, -
Herceptin2 (CHF 1.2 billion, -
Avastin2 (CHF 1.1 billion, -
MabThera/Rituxan2 (CHF 1.1 billion, -
Kadcyla (first approved in 2013; CHF 1.1 billion, +
Xolair2 (CHF 1.0 billion, +
Alecensa (first approved in 2015; CHF 745 million, +
Ronapreve (first approved in 2021; CHF 609 million, +
Lucentis2 (CHF 572 million, -
Evrysdi (first approved in 2020; CHF 500 million, +
Esbriet (first approved in 2014; CHF 457 million, -
Gazyva/Gazyvaro (first approved in 2013; CHF 349 million, +
Phesgo (first approved in 2020; CHF 325 million, +
Polivy (first approved in 2019; CHF 177 million, +
Vabysmo (first approved in 2022; CHF 109 million3). Neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME), two leading causes of vision loss. Sales of this new eye medicine showed an excellent uptake.
Enspryng (first approved in 2020; CHF 84 million, +
Rozlytrek (first approved in 2019; CHF 34 million, +
Susvimo (first approved in 2021; CHF 2 million3). Eye implant with continuous drug delivery for neovascular or ‘wet’ age-related macular degeneration (nAMD) treatment.
Diagnostics sales
Sales | CHF millions | As % of sales | % change | |||
January - June 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF |
Diagnostics Division | 9,948 | 9,042 | 100.0 | 100.0 | 11 | 10 |
Customer Areas | ||||||
Core Lab4 | 3,875 | 3,770 | 38.9 | 41.7 | 4 | 3 |
Point of Care4 | 2,609 | 1,798 | 26.2 | 19.9 | 46 | 45 |
Molecular Lab4 | 1,980 | 1,990 | 19.9 | 22.0 | 1 | -1 |
Diabetes Care | 832 | 894 | 8.4 | 9.9 | -5 | -7 |
Pathology Lab | 652 | 590 | 6.6 | 6.5 | 10 | 11 |
Regions | ||||||
Europe, Middle East, Africa | 3,350 | 4,144 | 33.4 | 45.8 | -14 | -19 |
North America | 2,868 | 2,055 | 29.0 | 22.7 | 34 | 40 |
Asia–Pacific | 3,171 | 2,293 | 32.0 | 25.4 | 39 | 38 |
Latin America | 559 | 550 | 5.6 | 6.1 | 2 | 2 |
Core Lab. Focuses on central labs; provides diagnostics solutions in the areas of immunoassays, clinical chemistry and custom biotech. Sales increased by
Point of Care. Focuses on diagnostics solutions in emergency rooms, medical practices or directly with patients; includes SARS-CoV-2 rapid tests, blood gas and electrolyte tests. Continued significant sales growth of
Molecular Lab. Focuses on molecular labs; provides diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics. The sales growth was driven by growth in the base business across the portfolio and by the GenMark business, which was acquired in April 2021. This growth was largely offset by lower COVID-19-related sales in the EMEA and North America regions. The Asia-Pacific region was the main driver of growth.
Diabetes Care. Focuses on integrated personalised diabetes management for people with diabetes and healthcare professionals. Sales decreased by
Pathology Lab. Focuses on pathology labs; provides diagnostics solutions for tissue biopsies and companion diagnostics. These targeted diagnostics support the specific therapy decisions for each patient. Sales increased by
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
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.
References
[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2021) and all total figures quoted are reported in CHF.
[2] Established products (launched before 2012), including Actemra/RoActemra, Avastin, Herceptin, MabThera/Rituxan, Xolair, Lucentis, Activase/TNKase, Pulmozyme and CellCept.
[3] Recently approved; no growth figures available.
[4] Sales in the Point of Care customer area include sales from the Liat business (POC molecular), and sales in the Core Lab customer area include sales from the Life Science Alliances business. These were both previously shown as part of the Molecular Lab customer area. The comparative information for 2021 has been restated accordingly.
POC molecular sales: Q1/21 = CHF 90m, Q2/21 = CHF 92m, Q3/21 = CHF 175m, Q4/21 = CHF 194m.
Life Science Alliances sales: Q1/21 = CHF 21m, Q2/21 = CHF 23m, Q3/21 = CHF 23m, Q4/21 = CHF 20m.
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 document, 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 this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.
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