[Ad hoc announcement pursuant to Art. 53 LR] Roche exceeds guidance and achieves sales growth of 1% (CER) for 2023 despite sharp COVID-19 sales decline
2024-02-01
- Group sales grow by 1%1 at constant exchange rates (CER; -7% in CHF), more than offsetting the decline in COVID-19-related sales and biosimilar erosion, and thereby exceeding 2023 guidance
- Excluding COVID-19 products, Group sales increase by 8%
- Pharmaceuticals Division sales increase by 6% (excluding COVID-19 medicine Ronapreve: +9%) due to ongoing high demand for newer medicines, with eye medicine Vabysmo continuing to be the top growth driver, followed by Ocrevus (multiple sclerosis), Hemlibra (haemophilia A) and Polivy (blood cancer)
- Diagnostics Division sales are 13% lower due to high demand for COVID-19 tests in 2022; strong momentum in the Diagnostics Division’s base business continues with an increase of 7%
- Highlights in the fourth quarter of 2023 and January 2024:
- US approval of Vabysmo (retinal vein occlusion, a severe eye disease)
- US priority review of Xolair (food allergies)
- EU approval of subcutaneous form of Tecentriq (cancer immunotherapy)
- Positive phase III data for inavolisib (breast cancer), Xolair (food allergies) and Hemlibra (babies with severe haemophilia A); positive longer-term data for Columvi and Lunsumio (blood cancer); positive long-term data for Kadcyla (breast cancer)
- US Breakthrough Device Designation for Elecsys NfL test (multiple sclerosis); launch of innovative new assays (hepatitis B and E)
- Acquisitions of Telavant (inflammatory bowel disease and other immunologic disorders) and Carmot (obesity and other metabolic diseases);
acquisition agreement with LumiraDx (point-of-care technology platform) - Roche (3rd) and Chugai (2nd) in Dow Jones Sustainability Indices
- IFRS net income increases 7% (-9% in CHF) to CHF 12.4 billion
- Core earnings per share increase by 6% (-9% in CHF)
- Board proposes dividend increase to CHF 9.60
- Change in Board of Directors
Outlook for 2024
Roche expects an increase in Group sales in the mid single digit range (at constant exchange rates). Core earnings per share are targeted to develop broadly in line with sales growth (at constant exchange rates), excluding the impact from resolution of tax disputes in 2023. Roche expects to further increase its dividend in Swiss francs.
| Key figures | CHF millions | % change | ||
| January–December 2023 | 2023 | 2022 | At CER1 | In CHF |
| Group sales | 58,716 | 63,281 | 1 | -7 |
| Pharmaceuticals Division | 44,612 | 45,551 | 6 | -2 |
| Diagnostics Division | 14,104 | 17,730 | -13 | -20 |
| Core operating profit | 19,240 | 22,173 | -1 | -13 |
| Core EPS – diluted (CHF) | 18.57 | 20.30 | 6 | -9 |
| IFRS net income | 12,358 | 13,531 | 7 | -9 |
Roche CEO Thomas Schinecker: “We achieved good sales growth that more than offset the sharp drop in COVID-19 sales. Roche’s base business – excluding COVID-19 – continued its strong growth momentum with +8% at constant exchange rates. As a result, we exceeded our guidance for 2023. At the same time, the significant appreciation of the Swiss franc versus most currencies strongly impacted results when reported in Swiss francs. We also made good progress in both our pharma and diagnostics product pipeline. One recent highlight is inavolisib, an oral therapy investigated in phase III trials which showed a reduction of more than 50% in the risk of death or worsening disease for patients suffering from advanced, hard-to-treat breast cancer. We look forward to bringing this medicine to patients as soon as possible. Our new partnerships and acquisitions address disease areas with high unmet needs, such as inflammatory bowel disease and cardiometabolic disease. We are well positioned for future growth.”
Change in Board of Directors
Bernard Poussot (born 1952), who has been a member of the Board of Directors since 2015, has decided not to stand for re-election at the Annual General Meeting in 2024. All other members of the Board will be proposed for re-election.
Severin Schwan, Chairman of the Board: “Bernard Poussot’s extensive leadership experience and profound knowledge of the pharmaceutical industry have resulted in significant contributions to Roche. I am sincerely thankful to him.”
Group results
In 2023, Roche achieved sales growth of 1% (-7% in CHF) to CHF 58.7 billion, exceeding the company’s guidance for the year. This increase more than made up for the expected decline in COVID-19-related sales, amounting to CHF 4.3 billion, and the effects of biosimilar erosion on our cancer medicines MabThera/Rituxan, Herceptin and Avastin, which totalled CHF 1.1 billion – resulting in an overall impact of CHF 5.4 billion (at CER).
The Swiss franc significantly appreciated versus most currencies, impacting results when reported in Swiss francs compared to constant exchange rates.
Core operating profit was down 1% (-13% in CHF) to CHF 19.2 billion. The good sales performance and a return towards a pre-COVID-19 sales mix resulted in an improved gross margin. This was offset by continued investments in pharmaceutical research, development and launches of new products. Additionally, the patent settlement income in Japan in 2022 affected the growth rate in 2023.
IFRS net income increased by 7% (-9% in CHF) to CHF 12.4 billion due to the increase in operating profit (IFRS) and lower income tax expenses.
Core earnings per share rose by 6% (-9% in CHF), including the positive impact from the resolution of tax disputes in 2023.
Sales in the Pharmaceuticals Division increased by 6% to CHF 44.6 billion, with newer medicines for severe diseases continuing their strong growth.
The top five growth drivers – Vabysmo (severe eye diseases), Ocrevus (multiple sclerosis), Hemlibra (haemophilia A), Polivy (blood cancer) and Phesgo (breast cancer) – achieved total sales of CHF 14.8 billion. This represents a plus of CHF 4.3 billion at CER compared to 2022.
Vabysmo, launched only in early 2022, reached sales of CHF 2.4 billion, and has become one of the best-selling medicines of Roche.
In the United States, sales rose by 8%. Vabysmo, Ocrevus and Hemlibra were the main growth drivers. This increase was partly offset by declining sales of medicines with expired patents.
Sales in Europe grew by 6%, with key contributions from Germany, France and the UK. The sales growth of Vabysmo, Phesgo, Evrysdi (spinal muscular atrophy), Hemlibra and Ocrevus more than compensated for the lower sales of Ronapreve (COVID-19) and medicines with expired patents.
In Japan, sales were down by 14%, mainly due to lower supply of Ronapreve to the government. Excluding Ronapreve, sales in Japan grew by 6%. This increase was fueled by the strong performance of newer medicines such as Polivy and Vabysmo, which effectively compensated for the impact of biosimilars.
Sales in the International region grew by 13%, led by China, Brazil and Canada. In China, sales rose by 6%, with Tamiflu (influenza), Xofluza (influenza) and the cancer medicines Polivy, Tecentriq and Perjeta being the key growth drivers, more than offsetting the impact of biosimilars and lower sales of CellCept (transplantation).
The Diagnostics Division’s base business sales increased by 7%, with immunodiagnostic products, particularly cardiac tests, and diagnostics solutions for clinical chemistry and for advanced staining contributing significantly to this growth.
Overall, the Diagnostics Division reported sales of CHF 14.1 billion, a decline of 13%. This reflects the anticipated significant drop in demand for COVID-19-related products (sales of CHF 0.8 billion in 2023, compared to sales of CHF 4.1 billion in 2022, both at CER).
With lower demand for COVID-19 testing, sales in the North America, EMEA and Asia-Pacific regions decreased by 21%, 13% and 11%, respectively. The division's base business grew across all regions.
Pharmaceuticals Division: pipeline
With 82 new molecular entities (NMEs) and a total of 146 projects, Roche has a promising pipeline with a wide variety of therapeutic approaches.
Pharmaceuticals research and development (R&D) expenditure grew by 6% to CHF 11.5 billion (Group R&D: +5% to CHF 13.2 billion). Oncology remained the primary area for R&D and cancer immunotherapy a key driver. Additionally, substantial investments were also made in neuroscience, ophthalmology and immunology.
Pharmaceuticals: key milestones in the fourth quarter of 2023
(incl. January 2024*)
| Compound | Milestone |
| Regulatory | |
| Tecentriq SC* Subcutaneous cancer immunotherapy | EU approves Tecentriq SC, the EU’s first subcutaneous anti-PD-(L)1 cancer immunotherapy injection for multiple cancer types
|
| Xolair Food allergies | Based on positive National Institutes of Health phase III study results, FDA grants priority review to Xolair for children and adults with food allergies
|
| Vabysmo Severe eye diseases | FDA approves Vabysmo for the treatment of retinal vein occlusion (RVO)
|
| Phase III, pivotal and other key readouts; data presentations; acquisitions and partnerships | |
| Columvi Blood cancer Lunsumio Blood cancer | New data for Columvi and Lunsumio presented at the annual meeting of the American Society of Hematology (ASH) 2023 support continued benefit for people with lymphoma
|
| Hemlibra Haemophilia A | New data reinforce the benefit of early preventative treatment with Hemlibra for babies with severe haemophilia A
|
| Kadcyla Breast cancer | Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment
|
| Inavolisib Breast cancer | Inavolisib combination reduces the risk of disease progression by 57% in people with advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation
|
| Carmot: CT-388 and CT-996 Obesity CT-868 Diabetes type 1 | Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, whose portfolio includes three clinical-stage assets with best-in-class potential in obesity and diabetes
|
| Elevidys Duchenne muscular dystrophy | EMBARK trial in Duchenne muscular dystrophy (DMD) does not reach primary endpoint but shows positive efficacy outcomes on all timed functional key endpoints
|
| Telavant: RVT-3101 Inflammatory bowel disease | Roche entered into a definitive agreement to acquire Telavant including rights to novel TL1A-directed antibody (RVT-3101) for the treatment of inflammatory bowel disease from Roivant
|
| Other Roche Group news | |
| Sustainability | Roche and Chugai named among top three most sustainable healthcare companies in the Dow Jones Sustainability Indices (DJSI)
|
Pharmaceuticals sales
| Sales | CHF millions | As % of sales | % change | |||
| January–December 2023 | 2023 | 2022 | 2023 | 2022 | At CER | In CHF |
| Pharmaceuticals Division | 44,612 | 45,551 | 100.0 | 100.0 | 6 | -2 |
| United States | 23,606 | 23,322 | 52.9 | 51.2 | 8 | 1 |
| Europe | 8,306 | 8,143 | 18.6 | 17.8 | 6 | 2 |
| Japan | 3,745 | 4,949 | 8.4 | 10.9 | -14 | -24 |
| International* | 8,955 | 9,137 | 20.1 | 20.1 | 13 | -2 |
*Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
| Top 20 best-selling pharmaceuticals | Total | United States | Europe | Japan | International | |||||
| CHF m | % | CHF m | % | CHF m | % | CHF m | % | CHF m | % | |
| Ocrevus Multiple sclerosis | 6,381 | 13 | 4,684 | 11 | 1,166 | 12 | - | - | 531 | 31 |
| Hemlibra Haemophilia A | 4,147 | 16 | 2,493 | 14 | 845 | 18 | 373 | 12 | 436 | 29 |
| Perjeta2 Breast cancer | 3,768 | 1 | 1,336 | -7** | 776 | -8 | 215 | 4 | 1,441 | 16 |
| Tecentriq Cancer immunotherapy | 3,766 | 9 | 1,941 | 4 | 845 | 10 | 419 | 8 | 561 | 29 |
| Actemra/RoActemra2 RA, COVID-19 | 2,630 | 5 | 1,223 | 9 | 775 | 0 | 311 | 3 | 321 | 4 |
| Vabysmo Eye diseases (nAMD, DME, RVO) | 2,357 | 324 | 1,914 | 293 | 276 | *** | 98 | 138 | 69 | *** |
| Xolair2 Asthma | 2,176 | 5 | 2,176 | 5 | - | - | - | - | - | - |
| Kadcyla2 Breast cancer | 1,966 | 4 | 757 | -2 | 577 | -11 | 102 | -12 | 530 | 43 |
| MabThera/Rituxan2 Blood cancer, RA | 1,630 | -15 | 987 | -20 | 180 | -9 | 24 | -13 | 439 | -6 |
| Herceptin2 Breast and gastric cancer | 1,626 | -16 | 331 | -26 | 353 | -14 | 30 | -33 | 912 | -13 |
| Avastin2 Various cancer types | 1,573 | -19 | 484 | -19 | 98 | -47 | 318 | -26 | 673 | -7 |
| Alecensa Lung cancer | 1,502 | 8 | 467 | 9 | 292 | 4 | 212 | 5 | 531 | 11 |
| Evrysdi Spinal muscular atrophy | 1,419 | 39 | 505 | 14 | 509 | 49 | 93 | 26 | 312 | 80 |
| Activase/TNKase Cardiac diseases | 1,173 | 6 | 1,112 | 6 | - | - | - | - | 61 | 5 |
| Phesgo Breast cancer | 1,120 | 64 | 423 | 48 | 534 | 52 | 4 | - | 159 | 189 |
| Polivy Blood cancer | 837 | 108 | 340 | 119 | 173 | 36 | 227 | 129 | 97 | 317 |
| Gazyva/Gazyvaro2 Blood cancer | 811 | 19 | 395 | 22 | 229 | 24 | 38 | -14 | 149 | 18 |
| Ronapreve COVID-19 | 525 | -65 | - | - | 5 | -95 | 519 | -60 | 1 | -99 |
| Lucentis Eye diseases | 460 | -52 | 460 | -52 | - | - | - | - | - | - |
| Pulmozyme Cystic fibrosis | 452 | -10 | 303 | -13 | 76 | -18 | 1 | 8 | 72 | 9 |
** Perjeta sales decline in the US mainly resulted from an adjustment related to government programmes. Excluding this adjustment, Perjeta sales in the US showed a growth of 1%.
*** Over 500%
DME: diabetic macular oedema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis
Diagnostics: key milestones in the fourth quarter of 2023
| Product | Milestone |
| Elecsys HBeAg quant Hepatitis B | Roche expands hepatitis diagnostics portfolio to help clinicians diagnose and monitor patients with acute or chronic hepatitis B infection
|
| Elecsys Anti-HEV IgM and Elecsys Anti-HEV IgG Hepatitis E | Roche launches automated serology hepatitis E virus tests, including a test to detect acute HEV infections, recommended in the new WHO 2023 Essential Diagnostics List
|
| Elecsys NfL test Multiple sclerosis | FDA grants Breakthrough Device Designation for Elecsys NfL test, an important aid for those living with multiple sclerosis
|
| Other Diagnostics news | |
| LumiraDx Point-of-care technology platform | Roche enters into a definitive agreement to acquire LumiraDx’s point-of-care technology combining multiple diagnostic modalities on a single platform
|
Diagnostics sales
| Sales | CHF millions | As % of sales | % change | |||
| January–December 2023 | 2023 | 2022 | 2023 | 2022 | At CER | In CHF |
| Diagnostics Division | 14,104 | 17,730 | 100.0 | 100.0 | -13 | -20 |
| Customer Areas3 | ||||||
| Core Lab | 7,750 | 7,775 | 55.0 | 43.9 | 9 | 0 |
| Molecular Lab | 2,220 | 3,450 | 15.7 | 19.5 | -30 | -36 |
| Pathology Lab | 1,388 | 1,318 | 9.8 | 7.4 | 14 | 5 |
| Point of Care | 1,379 | 3,589 | 9.8 | 20.2 | -58 | -62 |
| Diabetes Care | 1,367 | 1,598 | 9.7 | 9.0 | -4 | -14 |
| Regions | ||||||
| Europe, Middle East, Africa | 4,768 | 5,888 | 33.8 | 33.2 | -13 | -19 |
| North America | 3,826 | 5,141 | 27.1 | 29.0 | -21 | -26 |
| Asia–Pacific | 4,496 | 5,639 | 31.9 | 31.8 | -11 | -20 |
| Latin America | 1,014 | 1,062 | 7.2 | 6.0 | 14 | -5 |
More information on Roche performance in 2023:
- Full-Year 2023 Finance Report
- Full-Year 2023 Annual Report
- Full-Year 2023 Presentation
- Appendix with Tables
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 endeavour 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 fifteenth 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 2022) and all total figures quoted are reported in CHF.
[2] Products launched before 2015.
[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.
Point of Care: diagnostics solutions in emergency rooms, medical practices or directly with patients.
Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics.
Diabetes Care: integrated personalised diabetes management.
Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.
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.
Roche Global Media Relations
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