[Ad hoc announcement pursuant to Art. 53 LR] Roche records solid results for the first nine months of 2022
Group sales for Roche increased by 2% at constant exchange rates and 1% in Swiss francs in the first nine months of 2022, totaling CHF 47 billion. The Pharmaceuticals Division reported stable sales but faced significant declines in COVID-19-related products, while sales in the Diagnostics Division rose by 6%. New product launches included Vabysmo and Xofluza. The company's outlook for 2022 remains stable, with expected low-single-digit sales growth and a projected increase in dividends. Significant challenges include declines in established drug sales due to biosimilars and the waning demand for COVID-19 treatments.
- Sales growth in the Diagnostics Division by 6%.
- Launch of new medicines like Vabysmo for severe eye diseases.
- Continued high demand for newer treatments such as Ocrevus and Hemlibra.
- Confirmation of the yearly outlook with stable sales expectations.
- Significant decline in sales of COVID-19-related products, particularly Actemra/RoActemra and Ronapreve, resulting in a decrease of roughly CHF 1 billion.
- Sales in the Pharmaceuticals Division were flat compared to the previous year, indicating market stability but lacking growth.
- Decline in established medicines due to increased competition from biosimilars.
Basel, 18 October 2022
- Group sales up
2% 1 at constant exchange rates (CER) and1% in Swiss francs; as expected, significantly lower COVID-19-related sales in both divisions in the third quarter - Sales in the Pharmaceuticals Division at the previous year’s level with significantly lower sales of COVID-19-related products (Ronapreve and Actemra/RoActemra) and losses to biosimilars, offset by strong growth of newer medicines
- Sales in the Diagnostics Division rise
6% ; base business remains strong; as expected, demand for COVID-19 tests sharply down in third quarter - Highlights in the third quarter:
- EU approval for Vabysmo (severe eye diseases)
- US approvals for Xofluza (influenza in children)
- Launch of a digital PCR diagnostic platform and of COVID-19, skin and breast cancer tests
- “Breakthrough Device Designation” granted for Alzheimer’s blood tests
- Outlook for 2022 confirmed
Severin Schwan, CEO of Roche: “Group sales grew
Sales | CHF millions | As % of sales | % change | ||||
January–September 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF | |
Group sales | 47,037 | 46,684 | 100.0 | 100.0 | 2 | 1 | |
Pharmaceuticals Division | 33,189 | 33,379 | 70.6 | 71.5 | 0 | -1 | |
United States | 17,199 | 16,707 | 36.6 | 35.8 | -1 | 3 | |
Europe | 6,100 | 6,610 | 13.0 | 14.2 | -1 | -8 | |
Japan | 3,029 | 3,186 | 6.4 | 6.8 | 7 | -5 | |
International* | 6,861 | 6,876 | 14.6 | 14.7 | 0 | 0 | |
Diagnostics Division | 13,848 | 13,305 | 29.4 | 28.5 | 6 | 4 | |
*Asia-Pacific, CEETRIS (Central Eastern Europe, Turkey, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others |
Outlook for 2022 confirmed
Roche expects stable sales or sales growth in the low-single-digit range (at constant exchange rates). Core earnings per share are targeted to grow in the low- to mid-single-digit range (at constant exchange rates). Roche expects to increase its dividend in Swiss francs further.
Group sales
In the first nine months, the Roche Group generated sales growth of
As expected, the third quarter of 2022 was particularly challenging due to base effects, as the demand for COVID-19 medicines and tests was exceptionally high in the same quarter of 2021.
Sales of the Pharmaceuticals Division were at the same level as in the previous year, at CHF 33.2 billion.
The newer medicines Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Phesgo (breast cancer) continued their strong growth. The eye medicine Vabysmo, which was only launched at the beginning of the year, is now also one of the strongest growth drivers. These top-five medicines alone generated additional sales totalling CHF 2.2 billion.
As expected, sales growth was offset by the biosimilars-related decline in sales, especially for the established cancer medicines Avastin, MabThera/Rituxan and Herceptin. Sales of Actemra/RoActemra and Ronapreve (COVID-19) were also significantly lower than in the same period of 2021, with a decline of roughly CHF 1 billion, as the pandemic continued to weaken in many countries in 2022.
Sales in the United States decreased slightly with
In Europe, sales were also slightly down by
Sales were up in Japan (+
Sales in the International region were stable. The impact of biosimilars and decline in sales of Actemra/RoActemra was compensated by Perjeta, Kadcyla, Hemlibra and Ocrevus sales.
The Diagnostics Division generated a
As expected, the demand for COVID-19 tests declined sharply in the third quarter of 2022 (CHF 0.6 billion versus CHF 1.0 billion in the same period last year).
Sales in the Asia-Pacific and North America regions increased strongly, by
Pharmaceuticals: key approvals and development milestones in the third quarter of 2022
Ophthalmology
In September, the European Commission (EC) approved Vabysmo, the first bispecific antibody for the eye. Vabysmo simultaneously targets and inhibits two disease pathways that drive neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular oedema (DME) – two of the leading causes of vision loss. With the potential to require fewer eye injections over time, while also improving and maintaining vision, Vabysmo could offer a less burdensome treatment schedule for individuals, their caregivers and healthcare systems.
Oncology
In August, the FDA accepted the supplemental Biologics License Application (sBLA) for the Polivy combination therapy for previously untreated diffuse large B-cell lymphoma (DLBCL), an aggressive form of blood cancer. In four out of ten people with DLBCL, the cancer returns after initial treatment, at which point treatment options are limited and survival is short. Later in August, the Japanese health authorities granted approval for this Polivy combination in previously untreated DLBCL.
Also in August, Roche announced that the IMscin001 study met its co-primary endpoints. The study evaluated a subcutaneous formulation of cancer immunotherapy Tecentriq in people with advanced non-small cell lung cancer. Administered under the skin, this new formulation reduces the time spent receiving treatment to a matter of minutes, compared with up to an hour for an infusion.
Neuroscience
In October, Roche presented new data from its expanding neuromuscular disease portfolio. New two-year Evrysdi data show improvement or maintenance of motor function in people with spinal muscular atrophy (SMA). SMA is a severe, progressive neuromuscular disease that can be fatal. It is the leading genetic cause of infant mortality.
In addition, data from the gene therapy EMBARK study for Duchenne muscular dystrophy (DMD), the most advanced phase III study currently underway, reinforces our confidence in the programme. DMD is a rare, progressive neuromuscular disease, leading to a loss of muscle function and premature death.
Virology
In August, the FDA approved Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged five years and older. Historically, school-aged children have played a significant role in the community transmission of influenza. This approval marks the first single-dose oral influenza medicine approved in the US for children. Additionally, the FDA approved Xofluza for the prevention of influenza in children following contact with someone with influenza.
Pharmaceuticals: key development milestones in the third quarter of 2022
Compound | Indication | Milestone | |
Regulatory | Vabysmo | Neovascular or ‘wet’ age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME) | EU approval |
Xofluza | Acute uncomplicated influenza in otherwise healthy children aged five years and older | US approval | |
Xofluza | Prevention of influenza in children following contact with someone with influenza | US approval | |
Polivy combination | Previously untreated diffuse large B-cell lymphoma (DLBCL) | Submitted for US approval; Japan approval | |
Phase III, pivotal and other key readouts | Tecentriq | Subcutaneous formulation in people with advanced non-small cell lung cancer | IMscin001 study |
Evrysdi | Spinal muscular atrophy (SMA) | JEWELFISH, RAINBOWFISH and SUNFISH studies (updated data) |
Diagnostics: key milestones in the third quarter of 2022
In July, the FDA granted Breakthrough Device Designation to the Elecsys Amyloid Plasma Panel, an innovative new solution that enables Alzheimer’s disease to be detected earlier. This panel measures two blood-based biomarkers, called pTau 181 and ApoE4. It has the potential to streamline a patient’s journey and increase the speed of diagnosis, giving people living with Alzheimer’s disease and their caregivers more time to plan and prepare for the future.
In August, Roche launched the Digital LightCycler System. This next-generation digital PCR system helps clinical researchers better understand the nature of a patient’s cancer, genetic disease or infection. It has the potential to find and quantify ultra-rare, hard-to-detect disease mutations, leading to early diagnosis and therapy decisions.
Every four minutes, one person dies from skin cancer. However, when detected early, localised melanoma is curable with a simple surgical excision. The newly launched PRAME (EPR20330) Antibody test evaluates PRAME protein expression from patients with suspected melanoma. Identifying this critical biomarker helps clinicians determine if their patient has melanoma.
Approximately half of all patients with metastatic breast cancer express low levels of HER2 receptor protein. The newly launched PATHWAY anti-HER2 (4B5) test is the only FDA-approved companion diagnostic indicated as an aid in the assessment of HER2 low status in these patients. Historically these patients have simply been classified as HER2-negative, leaving them with few treatment options. They may now be eligible for targeted therapy.
With the launch of additional COVID-19 tests, Roche also reinforced its position as a world-leading supplier of COVID-19 diagnostics:
- The Elecsys IGRA SARS-CoV-2 test can help provide a deeper understanding of a person’s immune response to SARS-CoV-2 infection or vaccination. It will serve as an additional tool to make better-informed decisions around care, sanitary measures and treatment options – particularly important for at-risk patient groups.
(The test was launched in countries that accept the CE Mark.) - The next generation portfolio of SARS-CoV-2 Rapid Antigen tests (“2.0”) for self-testing and professional use feature innovative updates and enhanced performance, building on insights gained throughout the pandemic.
(These tests are used under the CE mark.)
Based on continuous analysis performed since the onset of the pandemic, all Roche molecular tests detect all SARS-CoV-2 variants.
Pharmaceuticals sales
Sales | CHF millions | As % of sales | % change | |||
January–September 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF |
Pharmaceuticals Division | 33,189 | 33,379 | 100.0 | 100.0 | 0 | -1 |
United States | 17,199 | 16,707 | 51.8 | 50.1 | -1 | 3 |
Europe | 6,100 | 6,610 | 18.4 | 20.0 | -1 | -8 |
Japan | 3,029 | 3,186 | 9.1 | 9.5 | 7 | -5 |
International* | 6,861 | 6,876 | 20.7 | 20.4 | 0 | 0 |
*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 | 4,427 | 17 | 3,283 | 13 | 808 | 25 | - | - | 336 | 37 |
Perjeta | 3,090 | 5 | 1,135 | 1 | 661 | -16 | 175 | -1 | 1,119 | 33 |
Hemlibra | 2,778 | 28 | 1,684 | 22 | 542 | 32 | 277 | 20 | 275 | 76 |
Tecentriq | 2,692 | 10 | 1,451 | 9 | 573 | 19 | 326 | -5 | 342 | 16 |
Actemra/RoActemra | 2,039 | -23 | 914 | -33 | 602 | -3 | 256 | 1 | 267 | -39 |
Herceptin | 1,672 | -18 | 376 | -28 | 329 | -13 | 40 | -28 | 927 | -15 |
Avastin | 1,652 | -29 | 497 | -36 | 158 | -51 | 378 | -15 | 619 | -21 |
Xolair | 1,625 | 10 | 1,625 | 10 | - | - | - | - | - | - |
MabThera/Rituxan | 1,596 | -20 | 1,002 | -20 | 156 | -18 | 24 | -10 | 414 | -23 |
Kadcyla | 1,590 | 11 | 619 | -3 | 508 | 8 | 101 | 21 | 362 | 50 |
* 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 4.4 billion, +
Perjeta (first approved in 2012; CHF 3.1 billion, +
Hemlibra (first approved in 2017; CHF 2.8 billion, +
Tecentriq (first approved in 2016; CHF 2.7 billion, +
Actemra/RoActemra2 (CHF 2.0 billion, -
Herceptin2 (CHF 1.7 billion, -
Avastin2 (CHF 1.7 billion, -
Xolair2 (CHF 1.6 billion, +
MabThera/Rituxan2 (CHF 1.6 billion, -
Kadcyla (first approved in 2013; CHF 1.6 billion, +
Alecensa (first approved in 2015; CHF 1.1 billion, +
Lucentis2 (CHF 800 million, -
Evrysdi (first approved in 2020; CHF 793 million, +
Ronapreve (first approved in 2021; CHF 631 million, -
Esbriet (first approved in 2014; CHF 590 million, -
Gazyva/Gazyvaro (first approved in 2013; CHF 539 million, +
Phesgo (first approved in 2020; CHF 526 million, +
Polivy (first approved in 2019; CHF 290 million, +
Vabysmo (first approved in 2022; CHF 282 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. Only launched in January 2022, the eye medicine is already one of the division’s strongest growth drivers.
Enspryng (first approved in 2020; CHF 133 million, +
Rozlytrek (first approved in 2019; CHF 53 million, +
Xofluza (first approved in 2018; CHF 6 million3). Acute, uncomplicated influenza, for people (including children) with high risk of developing flu-related complications; prevention of influenza following contact with an infected person.
Susvimo (first approved in 2021; CHF 3 million3). Eye implant with continuous drug delivery for neovascular or ‘wet’ age-related macular degeneration (nAMD) treatment.
Lunsumio (first approved in 2022; CHF 1 million3). Adult patients with relapsed or refractory follicular lymphoma. Promising market launch in first European countries.
Diagnostics sales
Sales | CHF millions | As % of sales | % change | |||
January–September 2022 | 2022 | 2021 | 2022 | 2021 | At CER | In CHF |
Diagnostics Division | 13,848 | 13,305 | 100.0 | 100.0 | 6 | 4 |
Customer areas | ||||||
Core Lab4 | 5,833 | 5,677 | 42.1 | 42.6 | 5 | 3 |
Point of Care4 | 3,086 | 2,415 | 22.3 | 18.2 | 30 | 28 |
Molecular Lab4 | 2,735 | 3,030 | 19.8 | 22.8 | -8 | -10 |
Diabetes Care | 1,219 | 1,294 | 8.8 | 9.7 | -3 | -6 |
Pathology Lab | 975 | 889 | 7.0 | 6.7 | 10 | 10 |
Regions | ||||||
Europe, Middle East, Africa | 4,595 | 5,715 | 33.2 | 43.0 | -13 | -20 |
North America | 3,923 | 3,139 | 28.3 | 23.6 | 20 | 25 |
Asia-Pacific | 4,522 | 3,611 | 32.7 | 27.1 | 28 | 25 |
Latin America | 808 | 840 | 5.8 | 6.3 | -3 | -4 |
Core Lab. Focuses on central labs; provides diagnostics solutions in the areas of immunoassays, clinical chemistry and custom biotech. Sales were up
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. With a plus of
Molecular Lab. Focuses on molecular labs; provides diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics. Sales declined 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 grew 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] 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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