[Ad hoc announcement pursuant to Art. 53 LR] Roche reports good results for 2022 despite decline in demand for COVID-19 products
Roche's group sales grew by 2% at constant exchange rates, totaling CHF 63.3 billion in 2022, despite a decline in COVID-19-related sales. The Pharmaceuticals Division saw a 2% increase in sales, bolstered by strong performance from newer medicines, while the Diagnostics Division grew by 3%.
Core earnings per share rose by 5%, but IFRS net income dropped by 6% to CHF 13.5 billion. Looking ahead, Roche anticipates low single-digit sales decline due to a projected CHF 5 billion drop in COVID-19 product sales, while new product launches suggest potential for solid growth.
- Sales growth of 2% in the Pharmaceuticals Division, driven by newer medicines.
- Diagnostics Division sales increased by 3%, with a 7% growth in the base business.
- Core earnings per share rose 5% to CHF 20.30.
- IFRS net income decreased by 6% to CHF 13.5 billion due to higher impairment and interest costs.
- Sales of COVID-19 medicines declined by CHF 0.5 billion, impacting overall sales.
- Roche expects a CHF 5 billion sales drop in COVID-19 products in 2023.
Basel, 2 February 2023
- Group sales grow by
2% 1 at constant exchange rates (CER) and1% in Swiss francs, despite lower COVID-19-related sales in both divisions - Pharmaceuticals Division sales increase by
2% ; continued strong growth of newer medicines more than compensating for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19) - Diagnostics Division sales grow by
3% ; ongoing strong momentum in base business (+7% ) more than compensating for the continuing decline in the demand for COVID-19 tests in the second half of the year - Highlights in the fourth quarter of 2022 (incl. January 2023):
- US approvals of Lunsumio (follicular lymphoma), Tecentriq (advanced rare sarcoma) and Actemra/RoActemra (COVID-19)
- US priority review of glofitamab (aggressive form of blood cancer)
- Positive phase III data for Vabysmo (serious retinal vascular condition) and for Tecentriq plus Avastin (early-stage liver cancer)
- Priority review for crovalimab (rare blood disease) in China
- New study proves high medical value of Elecsys NT-proBNP heart test
- US approval for Alzheimer’s tests; US Emergency Use Authorization for mpox virus test
- Core earnings per share rise by
5% (+2% in CHF) - IFRS net income amounts to CHF 13.5 billion (-
6% ; -9% in CHF) - Board proposes dividend increase to CHF 9.50. If approved by shareholders, this would be the 36th consecutive dividend increase.
Outlook for 2023
Due to the sharp decline in sales of COVID-19 products of roughly CHF 5 billion, Roche expects a decrease in Group sales in the low single digit range (at constant exchange rates). Excluding this COVID-19 sales decline, Roche anticipates solid underlying sales growth in both divisions.
Core earnings per share are targeted to develop broadly in line with sales decline (at constant exchange rates). Roche expects to further increase its dividend in Swiss francs.
Key figures | CHF millions | % change | ||
January–December 2022 | 2022 | 2021 | At CER1 | In CHF |
Group sales | 63,281 | 62,801 | 2 | 1 |
Pharmaceuticals Division | 45,551 | 45,041 | 2 | 1 |
Diagnostics Division | 17,730 | 17,760 | 3 | 0 |
Core operating profit | 22,173 | 21,897 | 3 | 1 |
Core EPS – diluted (CHF) | 20.30 | 19.81 | 5 | 2 |
IFRS net income | 13,531 | 14,935 | -6 | -9 |
Roche CEO Severin Schwan: “We achieved good results in 2022, even though the demand for COVID-19 products declined, as expected. The diagnostics base business and our newer medicines continued their strong growth. While we had pipeline setbacks in 2022, I am particularly pleased that we brought two new medicines to patients: Vabysmo for certain severe eye diseases and Lunsumio for a currently incurable form of blood cancer. For the current year we expect solid underlying growth in both divisions, which will largely compensate for the further significant drop in sales of roughly CHF 5 billion in COVID-19 products.”
Group results
In 2022, Roche achieved sales growth of
Core operating profit increased by
IFRS net income was CHF 13.5 billion, a decrease of
Core earnings per share increased by
Sales in the Pharmaceuticals Division increased by
Sales of COVID-19 medicines were generally lower (with a decline of roughly CHF 0.5 billion): the drop in sales of Actemra/RoActemra (severe COVID-19 pneumonia) was only partially made up by the sales growth of Ronapreve (high-risk patients) in Japan.
As expected, the impact of biosimilars on the sales of the cancer medicines MabThera/Rituxan, Herceptin and Avastin continued to slow down (combined CHF 1.9 billion of sales reduction).
Sales in the United States decreased slightly (-
In Europe, sales were also slightly down (-
Sales in Japan increased by a substantial
Sales in the International region grew by
The Diagnostics Division increased its sales by
Roche’s broad portfolio of COVID-19 tests generated sales totalling CHF 4.1 billion in 2022 (2021: CHF 4.7 billion).
Sales in the Asia-Pacific and North America regions increased by
Pharmaceuticals Division: pipeline
In 2022, Roche brought two important new medicines to patients: Vabysmo (serious eye diseases) and Lunsumio (blood cancer). Currently, Roche has a total number of 87 new compounds and 65 additional indications in clinical development or registration.
Oncology remained the primary area for research and development, with the cancer immunotherapy portfolio a key driver. Ophthalmology, neuroscience and immunology represent other significant areas of late-stage investments.
Key regulatory approvals, filings and read-outs in the fourth quarter of 2022
(incl. January 2023)
Oncology and haematology
Roche reached a number of regulatory milestones and presented new data from its leading haematology portfolio, which spans numerous blood diseases, including haemophilia A, paroxysmal nocturnal haemoglobinuria (PNH) and various types of blood cancers.
- Data from the HAVEN 7 study reinforced the efficacy and safety of Hemlibra in infants with severe haemophilia A without factor VIII inhibitors. These initial results support the benefit of starting treatment with Hemlibra at birth, as early preventive treatment in infants.
- Based on the results of the HAVEN 6 study, the CHMP recommended the expansion of the EU label for Hemlibra to include people with moderate haemophilia A. If approved, Hemlibra will offer an effective and convenient prophylactic treatment option for these people.
- New and updated data supported the use of Polivy in diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer, including its potential as a treatment option for previously untreated patients. In January 2023, China simultaneously approved two indications: Polivy for the treatment of previously untreated DLBCL, and for relapsed or refractory DLBCL.
- Positive new data from a phase III study in China demonstrated that crovalimab is effective and well-tolerated in people with PNH. PNH is an ultra-rare and life-threatening blood condition, where red blood cells are targeted and destroyed by the complement system, a part of the immune system. Based on these data, China granted priority review for approval of crovalimab.
- The FDA approved Lunsumio to treat people with relapsed or refractory follicular lymphoma (FL), a blood cancer that grows slowly, but is currently incurable. As a first-in-class T-cell-engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio with its high response rates and fixed duration could change the way advanced FL is treated.
- The FDA granted priority review for approval of glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with diffuse large B-cell lymphoma (DLBCL).
- Lunsumio and glofitamab are both part of Roche’s leading programme for bispecific CD20xCD3 antibodies. Recently presented data further support the potential of these two compounds as effective, off-the-shelf, fixed-duration treatment options for people with blood cancer.
In December, the FDA approved Tecentriq as the first-ever therapy for certain advanced sarcoma (alveolar soft part sarcoma; ASPS). ASPS is a rare, insidious soft tissue sarcoma most common in younger people that is often advanced at diagnosis, can spread slowly but inexorably over decades, and often returns following surgery. For those diagnosed with advanced ASPS, only an estimated
The FDA also accepted the Biologics License Application for the subcutaneous formulation of Tecentriq. If approved, this new formulation would be administered under the skin within minutes, compared with up to an hour for an infusion.
Today, more than
Ophthalmology
Vabysmo is the first bispecific antibody for the eye. It simultaneously targets and inhibits two signalling pathways that drive neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) – two of the leading causes of vision loss. Launched at the beginning of 2022, the eye medicine showed a strong uptake.
In October, new encouraging data from two global phase III studies demonstrated that Vabysmo could also provide a new treatment option for people living with retinal vein occlusion (RVO). RVO is a serious retinal vascular condition that can lead to irreversible vision impairment or vision loss. The results add to the extensive evidence supporting Vabysmo’s efficacy in treating multiple types of retinal conditions.
Neuroscience
Neurological conditions are very complex to understand and treat, but over the past few years Roche has made significant progress for patients with multiple sclerosis (MS), spinal muscular atrophy (SMA) and neuromyelitis optica spectrum disorder (NMOSD). The company is investigating more than a dozen pioneering medicines for neurological disorders.
In October, Roche presented new data for Ocrevus in MS. The data showed that early treatment with Ocrevus leads to reduced disease progression and healthcare costs, and new nine-year safety data reinforced the favourable benefit-risk profile of Ocrevus. In addition, results from more than 2,000 pregnant women with MS treated with Ocrevus do not suggest an increased risk of adverse pregnancy and infant outcomes.
In November, Roche announced results from the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer’s disease. The studies did not meet their primary endpoint of slowing clinical decline. Roche remains committed to Alzheimer’s disease, one of the most complex neurological disorders and a major public health challenge. The company is continuing to develop and deliver tests to enable early and accurate diagnosis and has a pipeline of investigational medicines for different targets, types and stages of the disease.
COVID-19
In December, the FDA approved Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults. Actemra/RoActemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalised patients and their healthcare providers who continue to be on the frontlines treating COVID-19. Since the beginning of the pandemic, more than one million people hospitalised with COVID-19 have been treated with Actemra/RoActemra worldwide.
Pharmaceuticals: key development milestones in the fourth quarter of 2022
(incl. January 2023*)
Compound | Indication | Milestone | |
Regulatory | Lunsumio | Relapsed or refractory follicular lymphoma (FL) | USA: approval (based on phase II GO29781 study) |
Actemra/ RoActemra | COVID-19 in hospitalised adults | USA: approval (based on RECOVERY and EMPACTA studies) | |
Tecentriq | Unresectable or metastatic alveolar soft part sarcoma (ASPS) | USA: approval (based on phase II study by US National Cancer Institute) | |
Tecentriq* | Subcutaneous formulation for the treatment of various cancers | USA: acceptance of Biologics License Application (based on phase III IMscin001 study) | |
Polivy combination* | Previously untreated diffuse large B-cell lymphoma (DLBCL) | China: approval (based on phase III POLARIX study) | |
Polivy combination* | Relapsed or refractory (R/R) DLBCL | China: approval (based on phase III POLAROSE study) | |
Glofitamab* | Diffuse large B-cell lymphoma (DLBCL) | USA: priority review (based on phase II NP30179 study) | |
Crovalimab | Paroxysmal nocturnal haemoglobinuria (PNH) | China: priority review (based on phase III COMMODORE 3 study) | |
Hemlibra | Moderate haemophilia A without inhibitors (prophylactic treatment option) | EU: recommendation of approval (based on HAVEN 6 study) | |
Xofluza | Treatment and prevention of influenza in children aged one year and above | EU: approval (based on phase III miniSTONE-2 and BLOCKSTONE studies) | |
Phase III, pivotal and other key readouts | Tecentriq plus Avastin* | Early-stage liver cancer (hepatocellular carcinoma; HCC) | Phase III IMbrave050 study |
Ocrevus | Early-stage relapsing-remitting multiple sclerosis (RRMS) | Phase IIIb ENSEMBLE study (2-year interim data) | |
Ocrevus | Multiple sclerosis in pregnant women | Roche safety data | |
Ocrevus | Multiple sclerosis long-term safety (RRMS and PPMS) | OPERA and ORATORIO OLE studies (9-year data) | |
Vabysmo | Retinal vein occlusion (RVO) | Phase III BALATON and COMINO studies | |
Hemlibra | Infants with severe haemophilia A without factor VIII inhibitors | Phase III HAVEN 7 study (interim data) | |
Hemlibra | Haemophilia A | EUHASS database (real-world safety data) | |
Hemlibra | Women with haemophilia A | ATHN 7 study | |
Polivy combination | Diffuse large B-cell lymphoma (DLBCL) | Phase III POLARIX study (new and updated data) | |
Gantenerumab | Early Alzheimer’s disease | Phase III GRADUATE I and II studies (primary endpoints not met) |
Pharmaceuticals Division: sales
Sales | CHF millions | As % of sales | % change | ||||||||||||||
January–December 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF | |||||||||||
Pharmaceuticals Division | 45,551 | 45,041 | 100.0 | 100.0 | 2 | 1 | |||||||||||
United States | 23,322 | 22,505 | 51.2 | 50.0 | -1 | 4 | |||||||||||
Europe | 8,143 | 8,876 | 17.8 | 19.7 | -2 | -8 | |||||||||||
Japan | 4,949 | 4,506 | 10.9 | 10.0 | 26 | 10 | |||||||||||
International* | 9,137 | 9,154 | 20.1 | 20.3 | 1 | 0 | |||||||||||
*Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, 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 | 6,036 | 17 | 4,487 | 14 | 1,075 | 25 | - | - | 474 | 35 | |||||||
Perjeta | 4,087 | 5 | 1,533 | 4 | 871 | -16 | 234 | 0 | 1,449 | 27 | |||||||
Hemlibra | 3,823 | 27 | 2,316 | 22 | 741 | 30 | 377 | 18 | 389 | 65 | |||||||
Tecentriq | 3,717 | 14 | 1,975 | 12 | 794 | 20 | 443 | -2 | 505 | 30 | |||||||
Actemra/RoActemra | 2,701 | -22 | 1,196 | -35 | 802 | -6 | 342 | 2 | 361 | -28 | |||||||
Xolair | 2,208 | 9 | 2,208 | 9 | - | - | - | - | - | - | |||||||
Herceptin | 2'142 | -19 | 476 | -28 | 422 | -17 | 51 | -28 | 1,193 | -15 | |||||||
Avastin | 2,122 | -28 | 634 | -34 | 193 | -52 | 490 | -17 | 805 | -20 | |||||||
Kadcyla | 2,080 | 7 | 820 | -3 | 671 | 5 | 131 | 16 | 458 | 34 | |||||||
MabThera/Rituxan | 2,075 | -20 | 1,316 | -19 | 204 | -19 | 32 | -14 | 523 | -24 | |||||||
* Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, 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 6.0 billion, +
Perjeta (first approved in 2012; CHF 4.1 billion, +
Hemlibra (first approved in 2017; CHF 3.8 billion, +
Tecentriq (first approved in 2016; CHF 3.7 billion, +
Actemra/RoActemra2 (CHF 2.7 billion, -
Xolair2 (CHF 2.2 billion, +
Herceptin2 (CHF 2.1 billion, -
Avastin2 (CHF 2.1 billion, -
Kadcyla (first approved in 2013; CHF 2.1 billion, +
MabThera/Rituxan2 (CHF 2.1 billion, -
Ronapreve (first approved in 2021; CHF 1.7 billion, +
Alecensa (first approved in 2015; CHF 1.5 billion, +
Evrysdi (first approved in 2020; CHF 1.1 billion, +
Lucentis2 (CHF 1.0 billion, -
Phesgo (first approved in 2020; CHF 740 million, +
Gazyva/Gazyvaro (first approved in 2013; CHF 730 million, +
Esbriet (first approved in 2014; CHF 718 million, -
Vabysmo (first approved in 2022; CHF 591 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.
Polivy (first approved in 2019; CHF 437 million, +
Enspryng (first approved in 2020; CHF 192 million, +
Rozlytrek (first approved in 2019; CHF 75 million, +
Xofluza (first approved in 2018; CHF 67 million, >
Lunsumio (first approved in 2022; CHF 3 million3). Adult patients with relapsed or refractory follicular lymphoma. Market launch in the first European countries is promising.
Susvimo (first approved in 2021; CHF 2 million, +
Diagnostics Division: key milestones in the fourth quarter of 2022
Patients admitted for acute heart failure are at high risk of readmission and death. In November, Roche shared the positive outcomes of the STRONG-HF study – which included the utilisation of our Elecsys NT-proBNP biomarker – in patients hospitalised with acute heart failure. It was the first time a cardiac-related diagnostic study was stopped early because of superior efficacy in the active arm of the study. Implementing the study’s strategy in routine clinical practice has the potential to create a paradigm shift in the management of heart failure patients. It emphasised how diagnostics solutions, embedded in a therapeutic strategy, are an integral part of improving patient care.
Globally, up to
In 2022, as with the COVID-19 pandemic, Roche demonstrated its ability to respond quickly to new public health threats. In spring, Roche was one of the first companies to develop a suite of tests to detect the mpox virus. In November, the FDA granted Emergency Use Authorization (EUA) for the cobas MPXV test for use on Roche’s fully automated, high-throughput platforms. This real-time PCR test can help individuals to get the right results quickly.
Roche’s broad COVID-19 portfolio has also been further strengthened. The cobas SARS-CoV-2 Qualitative test is one of the first FDA-approved COVID-19 PCR tests that is to be performed on fully automated, high-throughput platforms.
Testing early for COVID-19 can help determine the proper course of treatment. In this context, Roche announced its collaboration with Pfizer to drive awareness of the importance of timely COVID-19 testing and available treatment options.
Diagnostics Division: sales
Sales | CHF millions | As % of sales | % change | |||
January–December 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF |
Diagnostics Division | 17,730 | 17,760 | 100.0 | 100.0 | 3 | 0 |
Customer areas4 | ||||||
Core Lab | 7,775 | 7,560 | 43.9 | 42.6 | 6 | 3 |
Point of Care | 3,589 | 3,134 | 20.2 | 17.6 | 17 | 15 |
Molecular Lab | 3,450 | 4,174 | 19.5 | 23.5 | -15 | -17 |
Diabetes Care | 1,598 | 1,690 | 9.0 | 9.5 | -2 | -5 |
Pathology Lab | 1,318 | 1,202 | 7.4 | 6.8 | 11 | 10 |
Regions | ||||||
Europe, Middle East, Africa | 5,888 | 7,537 | 33.2 | 42.4 | -16 | -22 |
North America | 5,141 | 4,369 | 29.0 | 24.6 | 13 | 18 |
Asia–Pacific | 5,639 | 4,756 | 31.8 | 26.8 | 23 | 19 |
Latin America | 1,062 | 1,098 | 6.0 | 6.2 | -1 | -3 |
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. Sales grew by
Molecular Lab. Focuses on molecular labs; provides diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics. Sales decreased by
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 and Lucentis.
[3] No growth figures available (product recently approved or growth rate not meaningful).
[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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