[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth in base business of both divisions in the first quarter; Group sales decline due to expected drop in demand for COVID-19 tests
2023-04-26
临床结果临床3期上市批准
Basel, 26 April 2023
As expected, significantly lower demand for COVID-19 tests leads to a decrease in Group sales (-3%1 at constant exchange rates [CER] and -7% in Swiss francs); excluding this effect, Group sales grow 8%
Pharmaceuticals Division sales up 9%; strong demand for newer medicines; Vabysmo for severe eye diseases is already the strongest growth driver
Diagnostics Division base business grows 4%, while divisional sales are 28% lower due to exceptionally high demand for COVID-19 tests in the first quarter of 2022
Highlights in the first quarter: US approval of Polivy (first-line treatment for an aggressive form of blood cancer)
EU approval of Hemlibra (moderate haemophilia A)
Positive phase III data for Vabysmo (retinal vein occlusion, a serious eye disease), Tecentriq plus Avastin (adjuvant therapy for certain forms of liver cancer) and crovalimab (paroxysmal nocturnal haemoglobinuria, a rare blood disease)
Positive four-year efficacy and safety data for Evrysdi (spinal muscular atrophy)
Launch of new assays to identify clinically relevant mutations in brain cancers
Outlook for 2023 confirmed
Roche CEO Thomas Schinecker: “We saw strong growth in the first quarter in both divisions’ base business, which largely compensated for the expected drop in sales of COVID-19 tests. We made progress in our pipeline in the first quarter, especially in blood cancer. Besides our recent approvals for our bispecific antibody medicines, Lunsumio and Columvi, we have also just received US approval of Polivy as first-line treatment for an aggressive form of blood cancer. In ophthalmology, Vabysmo, a medicine for severe eye diseases, has shown positive phase III data in retinal vein occlusion. If approved, this would be the third indication for Vabysmo which has already become our strongest growth driver just a year after its launch. We confirm our outlook for 2023.”
Sales CHF millions As % of sales % change January‒March 2023 2023 2022 2023 2022 At CER In CHF Group 15,322 16,445 100.0 100.0 -3 -7 Pharmaceuticals Division 11,699 11,159 76.4 67.9 9 5 United States 5,853 5,489 38.2 33.4 6 7 Europe 2,071 2,072 13.5 12.6 5 0 Japan 1,390 1,337 9.1 8.1 18 4 International* 2,385 2,261 15.6 13.8 13 5 Diagnostics Division 3,623 5,286 23.6 32.1 -28 -31 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Outlook for 2023 confirmed
Core earnings per share are targeted to develop broadly in line with the sales decline (at constant exchange rates). Roche expects to further increase its dividend in Swiss francs.
Group results
In the first three months of the year, Group sales declined by 3% (-7% in CHF) to
CHF 15.3 billion. The appreciation of the Swiss franc against most currencies had a negative impact on the results reported in Swiss francs compared to constant exchange rates.
As expected, the first quarter 2023 results reflected the exceptionally high demand for COVID-19 tests in the same quarter of 2022, when the Omicron wave was at its peak.
Pharmaceuticals Division sales increased markedly by 9% to CHF 11.7 billion, driven by strong global demand for newer medicines to treat severe diseases.
The eye medicine Vabysmo, which was only launched in early 2022, became the division’s biggest growth driver. The top five contributors to growth – Vabysmo, Ocrevus (multiple sclerosis), Hemlibra (haemophilia), Evrysdi (spinal muscular atrophy) and Tecentriq (cancer immunotherapy) – generated additional sales of CHF 1.1 billion.
The Diagnostics Division’s base business recorded continued good growth (+4%).
Divisional sales were CHF 3.6 billion, down by 28% as sales of COVID-19 tests dropped to CHF 0.3 billion in the first quarter of 2023 from CHF 1.9 billion in the same period last year, when demand was exceptionally high.
Immunodiagnostic products, particularly cardiac tests, were the main growth drivers (+9%). Additional growth impulses came from the virology base business (+12%), blood screening (+15%) and diagnostics solutions for the detection and monitoring of cervical cancer (+22%).
The decline in sales across all regions is primarily due to the lower demand for COVID-19 tests. The Europe, Middle East and Africa (EMEA) and North America regions decreased by 30% and 39%, respectively. Asia-Pacific fell by 15%; Latin America reported a minus of 8%.
Pharmaceuticals: key development milestones in the first quarter of 2023
The Pharmaceuticals Division achieved a number of important product development milestones in the first three months of the year, including the US approval of Polivy (aggressive form of blood cancer), the EU approval of Hemlibra (moderate haemophilia A) as well as positive study results on Vabysmo for a serious retinal vascular condition and on crovalimab in PNH, a rare, life-threatening blood condition.
Compound Milestone Regulatory Hemlibra
Haemophilia A EU: label expansion to include moderate haemophilia A
Hemlibra, already approved for severe haemophilia A in the EU, will now also provide an effective and convenient prophylactic treatment option for people with moderate haemophilia A
Moderate haemophilia A can have a significant impact on the lives of people affected, with only 15% living a bleed-free life
The approval is based on the results of the HAVEN 6 study, where Hemlibra demonstrated effective bleed control and a favourable safety profile in people with moderate haemophilia A without inhibitors
More information: Media Release, 1 February
Columvi
Blood cancer Columvi (glofitamab) to receive approval in Canada for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
Columvi (glofitamab for injection) is the first CD20xCD3 T-cell-engaging bispecific antibody with fixed treatment duration approved in Canada to treat DLBCL
More information: local Media Release, 25 March Polivy
Blood cancer FDA approves Polivy in combination with R-CHP for people with certain types of previously untreated diffuse large B-cell lymphoma
Polivy combination is the first FDA-approved therapy in nearly 20 years for the first-line treatment of diffuse large B-cell lymphoma, an aggressive disease and the most common form of non-Hodgkin lymphoma in the US
POLARIX trial showed the Polivy combination reduced the risk of disease progression, relapse or death by 27% compared to the standard of care, R-CHOP, with a comparable safety profile
First-line treatment with Polivy plus R-CHP has the potential to reduce the burden on patients and healthcare systems, associated with disease progression
More information: Media Release, 20 April Phase III, pivotal and other key readouts Crovalimab
Haematology Positive data from global phase III programme for crovalimab in paroxysmal nocturnal haemoglobinuria (PNH), a rare, life-threatening blood condition
The COMMODORE 2 study met its co-primary efficacy endpoints, showing that crovalimab achieved disease control in people with PNH who had not been previously treated with complement inhibitors
The results of the phase III COMMODORE 1 study in people with PNH switching from currently approved C5 inhibitorsC5 inhibitors to crovalimab supported the favourable benefit-risk profile of crovalimab, as seen in the pivotal COMMODORE 2 study
Results from both studies will be submitted to regulatory authorities around the world and presented at an upcoming medical meeting
More information: Media Release, 7 February
Vabysmo
Severe eye diseases New phase III data show Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared to aflibercept
More Vabysmo patients displayed an absence of blood vessel leakage in the retina compared to aflibercept patients in a pre-specified exploratory endpoint
If approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema
More information: Media Release, 10 February Evrysdi
Spinal muscular atrophy New four-year data for Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)
Data from pivotal SUNFISH study showed that increases in motor function observed during the first year were maintained through the fourth year, while the overall rate of adverse events continued to decrease
Data confirm long-term efficacy and safety profile of Evrysdi in a broad range of people with type 2 and non-ambulant type 3 SMA
More than 8,500 people – from newborns to the over 60s – have been treated with Evrysdi, which is now approved in more than 90 countries worldwide
More information: Media Release, 20 March Vabysmo
Severe eye diseases Roche data highlight strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023
Vabysmo data suggest rapid and robust drying of retinal fluid in patients with neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema
Real-world data of Vabysmo demonstrate its ability to extend treatment intervals in the first four months while maintaining visual acuity
Clinical data on an investigational anti-interleukin-6 treatment in uveitic macular oedema will be presented for the first time
Liver cancer Tecentriq plus Avastin reduce the risk of cancer returning in people with certain types of liver cancer in a phase III study
In the first-ever positive phase III trial in the adjuvant hepatocellular carcinoma (HCC) setting, Tecentriq plus Avastin reduced the risk of disease recurrence by 28%
Up to 80% of people with this type of HCC experience disease recurrence, at which point they are faced with poorer prognosis and shorter survival
These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023
More information: Media Release, 16 April
Pharmaceuticals sales
Sales CHF millions As % of sales % change January–March 2023 2023 2022 2023 2022 At CER In CHF Pharmaceuticals Division 11,699 11,159 100.0 100.0 9 5 United States 5,853 5,489 50.0 49.2 6 7 Europe 2,071 2,072 17.7 18.7 5 0 Japan 1,390 1,337 11.9 12.0 18 4 International* 2,385 2,261 20.4 20.1 13 5 *Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others
Selected top-selling
and new medicines
Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus
Multiple sclerosis 1,636 14 1,188 13 298 11 - - 150 32 Perjeta2
Breast cancer 1,049 11 392 8 220 1 53 2 384 22 Hemlibra
Haemophilia A 1,034 24 631 21 206 27 92 24 105 38 Tecentriq
Cancer immunotherapy 920 15 507 14 195 11 105 12 113 34 Actemra/RoActemra2
COVID-19 567 9 - - - - 567 33 - - Kadcyla2
Breast cancer 509 5 198 -3 154 -6 26 -8 131 42 Xolair2
Asthma 479 5 479 5 - - - - - - Herceptin2
Breast and gastric cancer 477 -17 91 -37 97 -17 9 -30 280 -7 MabThera/Rituxan2
Blood cancer, RA 459 -17 274 -21 51 - 6 -13 128 -12 Vabysmo
Eye diseases (nAMD, DME) 432 ** 360 ** 44 - 21 - 7 - Avastin 2
Various cancer types 416 -24 133 -25 30 -45 91 -21 162 -19 Alecensa
Lung cancer 372 9 106 7 73 3 50 5 143 14 Evrysdi
Spinal muscular atrophy 363 62 124 13 113 74 21 47 105 189 Phesgo
Breast cancer 241 72 98 62 114 59 - - 29 232 Gazyva/Gazyvaro2
Blood cancer 197 24 99 32 55 25 8 -35 35 27 Lucentis2
Various eye diseases 167 -35 167 -35 - - - - - - Polivy
Blood cancer 150 96 46 35 40 93 51 169 13 340 Enspryng
NMOSD 54 42 15 16 4 96 33 44 2 246 Rozlytrek
Lung cancer 19 21 10 0 4 80 2 5 3 144 Xofluza
Blood cancer 14 - 13 - 2 - - - -1 - Susvimo
Eye implant 1 -33 1 -33 - - - - - - ** Over 500%
DME: diabetic macular oedema / nAMD: neovascular or ‘wet’ age-related macular degeneration / NMOSD: neuromyelitis optica spectrum disorders /
RA: rheumatoid arthritis
Diagnostics: key milestones in the first quarter of 2023
In the first quarter of the year, the Diagnostics Division launched important products in the areas of oncology and virology.
Product Milestone Regulatory IDH1 R132H and ATRX antibodies
Brain cancer Launch of two new antibodies to identify clinically relevant mutations in patients with brain cancer
Recent advances in cancer genomics have deepened the medical community’s understanding of the molecular alterations in brain tumours, more precisely subclassifying patients into specific diagnoses
Understanding a patient’s brain tumour mutation status in the IDH1 and ATRX genes enables more informed clinical decisions and may improve patient outcomes
The IDH1 R132H and ATRX antibodies are the latest additions to Roche’s neuropathology portfolio, which contains 29 biomarkers
More information: Media Release, 23 February VirSNiP SARS-CoV-2 Spike F486P
This new test for researchers specifically targets the XBB.1.5 Omicron sub-variant and runs on the real-time PCR platforms LightCycler 480 II and cobas z 480
Results from the test will help track the virus’ lineage closely and provide insights into the epidemiology and the impact it has on public health
Concern from the World Health Organization centres around the high transmissibility and growth advantage of XBB.1.5
More information: Media Release, 26 January Collaborations Elecsys Amyloid Plasma Panel
Alzheimer’s disease Collaboration with Lilly to enhance early diagnosis of Alzheimer’s disease
The panel has demonstrated clinical performance and is currently undergoing additional investigation to ensure clinical validation
Once approved, the panel could help healthcare professionals to streamline the journey to diagnosis for more patients
More information: Media Release, 22 March
Diagnostics sales
Sales CHF millions As % of sales % change January–March 2023 2023 2022 2023 2022 At CER In CHF Diagnostics Division 3,623 5,286 100.0 100.0 -28 -31 Customer Areas3 Core Lab 1,928 1,896 53.1 35.9 7 2 Molecular Lab 593 1,189 16.4 22.5 -48 -50 Point of Care 397 1,466 11.0 27.7 -72 -73 Diabetes Care 376 417 10.4 7.9 -5 -10 Pathology Lab 329 318 9.1 6.0 7 3 Regions Europe, Middle East, Africa 1,253 1,902 34.6 35.9 -30 -34 North America 1,029 1,705 28.4 32.2 -39 -40 Asia-Pacific 1,098 1,395 30.3 26.5 -15 -21 Latin America 243 284 6.7 5.4 -8 -14
More information on Roche sales in the first quarter of 2023:
Q1 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 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 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 custom biotech
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
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 Group Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
Hans Trees, PhD
Phone: +41 79 407 72 58 Nathalie Altermatt
Phone: +41 79 771 05 25
Karsten Kleine
Phone: +41 79 461 86 83 Nina Mählitz
Phone: +41 79 327 54 74
Dr. Barbara von Schnurbein
Phone: +41 79 699 97 44 Sileia Urech
Phone: +41 79 935 81 48
Attachments
Communications appendix tables_Q1 2023_Sales_v2
26042023_MR_Q1_Roche_en
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
来和芽仔聊天吧
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。