[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 saleswere up by 5% 1at 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 salesgrowth 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 Divisionsalesrose by 5% in the first half; strong growth of 8% in thebase business2...

Basel, 25/07/2024 (informazione.news - comunicati stampa - salute e benessere)

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.”

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.

Group results
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.

Sales in the International region increased by 17%, led by demand for Perjeta, Evrysdi, Phesgo and Tecentriq (cancer immunotherapy). Sales in China increased by 14%, driven by Perjeta, Alecensa (lung cancer), Avastin (liver cancer), Xofluza (influenza) and Polivy.

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

Pharmaceuticals sales

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

DME: diabetic macular oedema / nAMD: neovascular or 'wet' age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis

Diagnostics: key developments

Diagnostics sales

More information on Roche performance in the first half of 2024:

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 2023) and all total figures quoted are reported in CHF.
[2] Pharmaceuticals Division base business: excluding COVID-19 medicine Ronapreve.
Diagnostics Division base business: excluding COVID-19-related products.
[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.

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