[Ad hoc announcement pursuant to Art. 53 LR] Roche sales increase by 5% (CER) in first half of 2024; strong growth in second quarter – full-year earnings outlook raised
Group sales were up by 5%1 at constant exchange rates (CER) (stable in CHF) in the first half, driven by the high demand for both our medicines and diagnostics; excluding COVID-19-related products, sales increased by 8% Group sales growth accelerated to 9% (7% in CHF) in the second quarter as the decline in COVID-19-related sales no longer had an impact on overall sales Pharmaceuticals Division sales rose by 5% in the first half; strong growth of 8% in the base business2 excluding COVID-19 effect was driven by continued high demand for our newer medicines to treat severe diseases; eye medicine Vabysmo was again the major growth driver Diagnostics Division sales rose by 5%, while growth in the base business2, which excludes the impact of COVID-19 sales, was 9% due to higher demand for immunodiagnostic products Core operating profit increased by 11% (4% in CHF), core earnings per share grew by 9% (1% in CHF) and IFRS net income was down by 4%
Outlook for 2024 earnings raised
US approval for Vabysmo prefilled syringe for three leading causes of vision loss and PiaSky for a rare blood condition; US filing acceptance for Susvimo in two leading causes of vision loss in adults with diabetes CE mark for Accu-Chek SmartGuide, an AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes US approval of human papillomavirus (HPV) self-collection solution, the first available in the country to allow women to privately collect their samples; two new WHO prequalifications for cervical cancer screening tools, including HPV self-collection solution Launch of new analytical units, cobas c 703 and cobas ISE neo, to deliver higher testing capacity and increased automation for laboratories
US emergency use authorisation for cobas liat four-in-one molecular test for some of the most prevalent respiratory viruses
Roche CEO Thomas Schinecker: “Our strong sales growth in the first half of 2024 reflects the high demand for our innovative medicines and diagnostics. In the second quarter, we saw an acceleration of our growth momentum as Group sales were no longer impacted by the decline in COVID-19 sales, resulting in very strong sales growth for the Group. Based on our strong half-year results, we are raising our earnings outlook for the full year. We also received a number of important regulatory approvals in the last three months, including EU approval for Alecensa for a form of early-stage lung cancer, as well as for the subcutaneous injection of Ocrevus, which provides an additional treatment option for multiple sclerosis. I am particularly pleased about the US approval for the ready-to-use prefilled syringe of our eye medicine Vabysmo, which continues to be our main growth driver. In diagnostics, our new Accu-Chek SmartGuide solution for continuous blood glucose monitoring uses artificial intelligence to provide reliable blood glucose level forecasts for several hours.” Key figures CHF millions % change January–June 2024 2023 At CER1 In CHF Group sales 29,848 29,779 5 0 Pharmaceuticals Division sales 22,637 22,511 5 1 Diagnostics Division sales 7,211 7,268 5 -1 Core operating profit 11,293 10,911 11 4 Core EPS – diluted (CHF) 10.23 10.10 9 1 IFRS net income 6,697 7,563 -4 -11 Outlook for 2024 earnings raised
Roche expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to grow in the high single digit range (CER), excluding the impact from the resolution of tax disputes in 2023.
Roche expects to further increase its dividend in Swiss francs. In the first half of 2024, Group sales were up by 5% at CER (stable in CHF) at CHF 29.8 billion. While the appreciation of the Swiss franc slowed against most currencies, it had an adverse impact on the results presented in Swiss francs compared to constant exchange rates.
Core operating profit grew by 11% (4% in CHF), driven by higher sales and cost management.
Core earnings per share increased by 9% (1% in CHF). IFRS net income was 4% lower (-11% in CHF), mainly due to the impairment of product and technology intangible assets in the research or development phase following strategic decisions. In addition, the IFRS result was impacted by the base effect of the release of provisions related to litigations in the first half of 2023.
The Pharmaceuticals Division base business grew by 8%, while divisional sales increased by 5% to CHF 22.6 billion, driven primarily by higher sales of Vabysmo (severe eye diseases), with growing demand for Phesgo (breast cancer), Ocrevus (multiple sclerosis), Polivy (blood cancer) and Evrysdi (spinal muscular atrophy). These five medicines together generated total sales of CHF 7.3 billion, an increase of CHF 1.8 billion (CER) from the first half of 2023. The eye medicine Vabysmo, launched in early 2022, remained a major growth driver, generating sales of CHF 1.8 billion on growing demand in all regions, mainly the US.
Sales of MabThera/Rituxan, Herceptin and Avastin decreased by a combined CHF 0.4 billion (CER) as the impact of biosimilar competition slowed further. Sales of the COVID-19 medicine Ronapreve were minimal compared with CHF 0.5 billion in the first half of 2023. In the United States, sales grew by 5% as increased sales of Vabysmo, Polivy, Ocrevus and Xolair (food allergies) were partially offset by the continued decline in sales of medicines for which patent protection has expired. Vabysmo achieved CHF 1.4 billion in sales, showing a high uptake in both new patients and patients switching from other medications. In Europe, sales surged by 10%, driven by demand for Vabysmo in France, the UK and Germany as well as by the continued uptake of Phesgo, Ocrevus, Hemlibra (haemophilia) and Evrysdi. This was partially offset by lower sales of medicines for which patent protection has expired and of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo. Sales in Japan were down 28%, mainly due to the base effect of the supply of Ronapreve (COVID-19) to the government in the first half of 2023. Excluding this effect, sales in Japan were 5% lower as strong demand for Phesgo was more than offset by the impact of government price cuts. The Diagnostics Division base business grew by 9%, while divisional sales increased by 5% to CHF 7.2 billion. Immunodiagnostic products, which include cardiac, oncology and thyroid tests, were the main growth drivers (11%). Additional growth impetus came from clinical chemistry (8%), advanced staining techniques in oncology (11%) and from companion diagnostics (46%).
The continued good growth in the division’s base business was partially offset by the expected sales decline of COVID-19-related products. Sales of COVID-19 tests further declined to CHF 0.1 billion in the first half of 2024 from CHF 0.4 billion in the corresponding period last year. Sales growth was reported across all regions, with the Europe, Middle East and Africa (EMEA) region growing by 4%, North America by 5%, Asia-Pacific by 3% and Latin America by 16%.
Pharmaceuticals: key developments
Compound Milestone Regulatory Susvimo
The FDA has approved updates to Susvimo, which will be available to US retina specialists and patients with nAMD in the coming weeks Susvimo offers the first alternative to regular eye injections that are standard of care for nAMD, which impacts 20 million people worldwide and can cause blindness if left untreated By continuously delivering medicine to the eye through a refillable implant, Susvimo is the first and only approved nAMD treatment shown to maintain vision with two refills a year More information: Media Release, 8 July 2024 Vabysmo prefilled syringe
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option
Vabysmo PFS will be available for people living with nAMD, DME and RVO
More information: Media Release, 5 July 2024 Vabysmo
Positive recommendation is based on two phase III studies. In addition to robust retinal drying with Vabysmo, these data show early and sustained vision improvements, which are non-inferior to aflibercept If approved, Vabysmo would be the first and only bispecific antibody treatment available for the nearly one million people with RVO in the European Union Vabysmo is already approved in the US and Japan for RVO and in more than 95 countries around the world for people living with nAMD and DME More information: Media Release, 28 June 2024 PiaSky
Rare blood condition CHMP recommends EU approval of PiaSky for people with PNH, a rare, life-threatening blood condition Additionally, with the option of self-administration, PiaSky may provide an alternative to existing intravenous (IV) C5 inhibitorsC5 inhibitors, potentially helping to reduce treatment burden The recommendation is based on the results of the COMMODORE 2 study, where SC PiaSky given every month demonstrated equivalent disease control and comparable safety to IV eculizumab given every two weeks More information: Media Release, 28 June 2024 Ocrevus
Ocrevus subcutaneous (SC) injection offers a new, 10-minute administration of Ocrevus with comparable efficacy and safety to intravenous infusion (IV) Ocrevus SC provides an additional treatment option without the need for IV facilities, expanding accessibility for patients More information: Media Release, 25 June 2024 Elevidys
Elevidys is already approved in the US, Qatar, Kuwait, UAE, Oman and Bahrain More information: Investor Update, 24 June 2024 Alecensa
The approval of Alecensa addresses an urgent unmet need in the early-stage setting where about half of all people experience disease recurrence following surgery, despite adjuvant chemotherapy Early diagnosis and treatment of lung cancer can reduce the burden associated with progressive disease and give people the best possible chance of cure More information: Media Release, 10 June 2024 Inavolisib
Priority review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options Additional analyses of INAVO120 were presented in an oral abstract session at the 2024 American Society of Clinical Oncology Annual Meeting
The target action date for the FDA decision is 27 November 2024 More information: Media Release, 29 May 2024 Inavolisib The designation is based on phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting This is the 29th Breakthrough Therapy Designation for Roche’s oncology portfolio, a testament to our enduring ambition to deliver transformative medicines for patients More information: Media Release, 21 May 2024
Phase III, pivotal and other key readouts; data presentations Susvimo
Severe eye disease New data for Susvimo demonstrate sustained efficacy in two serious diabetic eye conditions Safety data were consistent with the known safety profile for Susvimo in people with DME and DR Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant More information: Media Release, 18 July 2024 Vabysmo
More than 90% of patients had absence of DME after four years in a pre-specified exploratory endpoint People treated with Vabysmo sustained vision gains and anatomical improvements, with almost 80% receiving treatment at intervals of three or four months, in an exploratory analysis The study met all primary endpoints, showing safety data were consistent with the known safety profile of Vabysmo This is the largest long-term extension dataset in DME to date, demonstrating consistent positive results in a highly prevalent eye condition More information: Media Release, 17 July 2024 CT-996 After four weeks of treatment, CT-996 demonstrated clinically meaningful weight loss of -7.3% (weight loss in placebo -1.2%; p Pharmacokinetic data support a once-daily oral dosing regimen for CT-996 The safety and tolerability profile was consistent with that of other oral GLP-1 receptor agonists and no unexpected safety signals were observed More information: Media Release, 17 July 2024 Tiragolumab SKYSCRAPER-06, evaluating tiragolumab plus Tecentriq and chemotherapy, did not meet the primary endpoints of progression-free survival at primary analysis and overall survival at first interim analysis The combination of tiragolumab plus Tecentriq and chemotherapy showed reduced efficacy compared to the comparator arm Safety was consistent with previous studies; however, Roche intends to halt the trial due to reduced efficacy compared to the comparator arm More information: Media Release, 4 July 2024 Columvi
This Columvi combination could provide a much-needed off-the-shelf treatment option for people with transplant-ineligible R/R DLBCL
Data were featured in the congress press briefing and presented in the Plenary Abstracts Session at EHA 2024 as a late-breaking oral presentation
More information: Media Release, 15 June 2024 Evrysdi
After five years of treatment, 91% of children were alive — without treatment, children with type 1 SMA would not be expected to live past two years of age 96% of children treated with Evrysdi could swallow, 80% could feed without a feeding tube and 59% could sit without support for at least 30 seconds Evrysdi is now approved in more than 100 countries with over 15,000 patients treated globally More information: Media Release, 7 June 2024 CT-388 Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% weight loss and 45% achieved >20% weight loss In a subgroup with pre-diabetes at baseline, CT-388 treatment normalised glycaemia in all patients, indicating its strong impact on glucose homoeostasis No new or unexpected safety signals were detected. Overall, CT-388 demonstrated a safety and tolerability profile consistent with its drug class More information: Media Release, 16 May 2024
Sales CHF millions As % of sales % change January–June 2024 2023 2024 2023 At CER In CHF Pharmaceuticals Division 22,637 22,511 100.0 100.0 5 1 United States 11,882 11,573 52.5 51.4 5 3 Europe 4,425 4,105 19.5 18.2 10 8 Japan 1,366 2,210 6.0 9.8 -28 -38 International* 4,964 4,623 22.0 20.6 17 7 All figures shown in the table were restated to reflect the shift of the Foundation Medicine (FMI) business from the Pharmaceuticals Division to the Diagnostics Division.
*Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, other
Top-selling medicines Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Haemophilia A 2,143 7 1,231 1 468 14 171 3 273 32 Perjeta3
Cancer immunotherapy 1,798 2 898 -8 429 10 182 -2 289 32 Vabysmo RA, COVID-19 1,276 3 595 6 363 -3 146 7 172 4 Xolair3 Asthma 1,110 10 1,110 10 - - - - - - Kadcyla3 Breast and gastric cancer 740 -11 138 -19 154 -14 8 -44 440 -5 MabThera/Rituxan3
Blood cancer, RA 706 -17 422 -19 77 -17 9 -23 198 -11 Avastin 3 Various cancer types 654 -16 199 -20 44 -20 102 -33 309 -4 Activase/TNKase3 Immunosuppressant 197 4 12 -26 60 -5 18 -10 107 19
Diagnostics: key developments
Product Milestone Accu-Chek SmartGuide
Diabetes management CE mark for AI-enabled continuous glucose monitoring solution offering critical predictions to people living with diabetes The Accu-Chek SmartGuide CGM solution provides accurate real-time glucose values for adults living with type 1 and type 2 diabetes on flexible insulin therapy The built-in AI-trained algorithms will empower users to proactively intervene when their glucose levels require attention and before a complication can even occur
The solution is set to launch in selected European markets in the coming months
More information: Media Release, 9 July 2024 cobas 5800, 6800 and 8800 systems
Human papillomavirus (HPV) Roche expands access to cervical cancer screening tools with two new WHO prequalification designations, including HPV self-collection The World Health Organization (WHO) has awarded Roche’s human papillomavirus (HPV) test prequalification designations for use on the cobas 5800 system and for self-collected samples on the cobas 5800, 6800 and 8800 systems These designations build upon last June’s WHO prequalification that included the cobas HPV test for use on the cobas 6800 and 8800 systems
WHO prequalification enables low- and middle-income countries (LMICs) to use Roche HPV screening solutions, including self-collection, in their national cervical cancer elimination programmes, which will greatly increase access Every year, over 600,000 women worldwide are diagnosed with cervical cancer and over 340,000 die from this preventable disease caused by HPV infection. Nine out of 10 women who die from cervical cancer live in LMICs More information: Media Release, 27 June 2024 cobas pro integrated solutions
Roche launches new analytical units for cobas pro integrated solutions delivering greater efficiency and capacity to laboratories The cobas c 703 and cobas ISE neo analytical units deliver higher testing capacity and increased automation, helping to improve laboratory workflows and advance patient care
The new cobas c 703 analytical unit offers industry-leading high-throughput clinical chemistry testing with up to 2,000 tests per hour and 70 reagent positions, doubling the existing clinical chemistry throughput on cobas pro integrated solutions
The new cobas ISE neo analytical unit delivers more efficient ISE testing, reducing hands-on time through automated maintenance
More information: Media Release, 24 June 2024 VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes The test helps differentiate a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers and their patients More information: Media Release, 20 June 2024 cobas liat system
Roche four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and RSV receives US FDA Emergency Use Authorisation The test uses highly sensitive PCR technology, requiring only a single nasal-swab sample to provide rapid, accurate qualitative detection and differentiation among four of the most prevalent respiratory viruses for which differential diagnosis can drive appropriate treatment
It enables healthcare professionals to make confident clinical decisions and promptly determine appropriate treatment, with definitive results reported in just 20 minutes
It expands Roche’s extensive molecular point-of-care testing portfolio, offering greater flexibility to meet testing needs amid evolving regional prevalence of respiratory infections More information: Media Release, 10 June 2024 Tina-quant lipoprotein (a) RxDx
Cardiovascular diseases FDA Breakthrough Device Designation for blood test measuring Lp(a) – a key marker for hereditary cardiovascular risk The Tina-quant Lp(a) assay measures lipoprotein (a) in a person’s bloodstream, and will be made available on Roche’s installed base of over 90,000 serum work area (SWA) systems worldwide The test was developed in collaboration with Amgen More information: Media Release, 22 May 2024 HPV self-collection solution
Human papillomavirus (HPV)
FDA approval for one of the first HPV self-collection solutions in the US, expanding access and screening options to help eliminate cervical cancer More than half of all US cervical cancer patients are underscreened, which makes reducing barriers to sample collection and increasing access to screenings crucial to ultimately helping eliminate this deadly disease Each year in the US, more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection Roche’s human papillomavirus (HPV) self-collection solution will improve access to testing by providing women the option to privately collect their own sample More information: Media Release, 15 May 2024
Sales CHF millions As % of sales % change January–June 2024 2023 2024 2023 At CER In CHF Diagnostics Division 7,211 7,268 100.0 100.0 5 -1 Customer Areas4 Core Lab 4,069 3,935 56.4 54.1 10 3 Molecular Lab5 1,275 1,288 17.7 17.7 3 -1 Near Patient Care6 1,097 1,358 15.2 18.7 -14 -19 Pathology Lab 770 687 10.7 9.5 17 12 Regions Europe, Middle East and Africa 2,431 2,456 33.7 33.8 4 -1 North America5 2,163 2,110 30.0 29.0 5 3 Asia-Pacific 2,102 2,205 29.2 30.3 3 -5 Latin America 515 497 7.1 6.9 16 4 More information on Roche performance in the first half of 2024:
Half-Year 2024 Finance Report
Half-Year 2024 Presentation
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. For more information, please visit www.roche.com.
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[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2023) and all total figures quoted are reported in CHF.
[3] Products launched before 2015.
[4] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech. Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling. Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management. Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.
[5] Sales in the Molecular Lab customer area include sales from the Foundation Medicine business which moved under the responsibility of the Diagnostics Division from the Pharmaceuticals Division effective 1 January 2024. The comparative information for 2023 has been restated accordingly. [6] Sales in the new Near Patient Care customer area include sales from Diabetes Care and the Point of Care business, both previously shown as separate customer areas. The comparative information for 2023 has been restated accordingly. 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 Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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Communications appendix tables_HY 2024_Sales+Results