[Ad hoc announcement pursuant to Art. 53 LR] Roche's strong sales growth of 9% (CER) continues in the third quarter of 2024; Group sales increase 6% in the first nine months

• Group sales grew by 6%¹ at constant exchange rates (CER) (2% in CHF) in the first nine months, driven by the high demand for both our medicines and diagnostics; excluding COVID-19-related products, sales increased by 8%
• In the third quarter, Group sales rose by 9% (6% in CHF), as they did in the second quarter
• Pharmaceuticals Division sales rose by 7% in the first nine months; the strong growth of 9% in the base business² was driven by continued high demand for our newer medicines to treat severe diseases; Vabysmo (serious eye diseases), Phesgo (breast cancer) and Ocrevus (multiple sclerosis) were major growth drivers
• Diagnostics Division sales increased by 5% in the first nine months, while the base business² grew by 8% due to higher demand for immunodiagnostic, pathology and molecular solutions
• Highlights:
  • US approval for Itovebi (inavolisib) for breast cancer, Ocrevus Zunovo subcutaneous injection for multiple sclerosis and Tecentriq Hybreza subcutaneous formulation for various types of cancer
  • EU approval for Vabysmo for retinal vein occlusion (RVO), a serious eye disease, and PiaSky for paroxysmal nocturnal haemoglobinuria (PNH), a rare life-threatening blood condition
  • Positive phase III data for Gazyva/Gazyvaro (lupus nephritis, a kidney disease), Xofluza (influenza) and Tecentriq (lung cancer). New positive phase II data for fenebrutinib (multiple sclerosis), and new positive long-term data for Evrysdi (spinal muscular atrophy)
  • Acquired AntlerA Therapeutics for a novel target in ophthalmology, and signed agreement for the acquisition of two next-generation CDK inhibitor drugs targeting breast cancer from Regor Pharmaceuticals
  • Closing of acquisition of LumiraDx's point-of-care technology to expand access to diagnostic testing in primary care and low- and middle-income countries
  • Launch of the cobas Respiratory flex test, the first to use our new Temperature-Activated Generation of Signal (TAGS) technology
  • WHO endorsement for CINtec PLUS testing for cervical cancer prevention
• Outlook for 2024 confirmed

Roche CEO Thomas Schinecker: “Our strong growth momentum continued in the third quarter, reflecting the high demand for our innovative medicines and diagnostic solutions and their positive impact on patients' lives around the world.

We made significant progress in our pharmaceuticals portfolio in the last quarter with five important regulatory approvals for our medicines, three positive phase III read-outs, and two acquisitions to strengthen our oncology and ophthalmology pipelines.

Itovebi (inavolisib) recently received US approval based on clinical data demonstrating a reduction of more than 50% in the risk of death or worsening disease for people suffering from a form of advanced, hard-to-treat breast cancer. In addition, we had positive phase III results for Gazyva/Gazyvaro in lupus nephritis, a potentially life-threatening kidney disease for which limited treatment options are available today.

We confirm our outlook for 2024.”

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, others

Outlook for 2024 confirmed
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 sales
In the first nine months of 2024, Group sales increased by 6% at CER (2% in CHF) to CHF 45.0 billion as strong demand for our novel medicines as well as diagnostic products including immunodiagnostic, pathology and molecular solutions more than offset the anticipated decline in COVID-19-related sales and the impact of biosimilar/generic erosion.

The appreciation of the Swiss franc against most currencies had an adverse impact on the sales reported in Swiss francs compared to constant exchange rates.

The Pharmaceuticals Division sales increased by 7% to CHF 34.3 billion, while the base business (excluding COVID-19) grew by 9%, driven primarily by higher sales of Vabysmo (severe eye diseases), Phesgo (breast cancer), Ocrevus (multiple sclerosis), Hemlibra (haemophilia) and Polivy (blood cancer).

These five medicines together generated total sales of CHF 13.2 billion, an increase of CHF 2.7 billion (CER) from the first nine months of 2023.

The eye medicine Vabysmo, launched in early 2022, continues to be a major growth driver, generating sales of CHF 2.8 billion on growing demand in all regions.

Sales of Avastin (various types of cancer), Herceptin (breast and gastric cancer) and MabThera/Rituxan (blood cancer, rheumatoid arthritis) decreased by a combined CHF 0.5 billion as the impact of biosimilar competition slowed further. Sales of the COVID-19 medicine Ronapreve were negligible compared with CHF 0.5 billion in the first nine months of 2023.

In the United States, sales grew by 7% as strong sales of Vabysmo, Ocrevus, Polivy and Xolair (food allergies) were partially offset by the continued decline in sales of medicines for which patent protection has expired. Vabysmo achieved CHF 2.1 billion in sales, showing a high uptake in both new patients and patients switching from other medications.

In Europe, sales rose by 7%, driven by demand for Vabysmo as well as by the continued uptake of Phesgo, Ocrevus, Evrysdi (spinal muscular atrophy) and Hemlibra. This was partially offset by lower sales of medicines for which patent protection has expired and of Perjeta (breast cancer) due to the ongoing conversion of patients to Phesgo.

Sales in Japan were down 21%, mainly due to the base effect of the supply of Ronapreve (COVID-19) to the government in the first quarter of 2023. Excluding this effect, sales in Japan were 3% lower as strong demand for Phesgo and Vabysmo was more than offset by the impact of government price cuts and lower sales of medicines for which patent protection has expired.

Sales in the International region surged by 19%, led by demand for Perjeta, Hemlibra, Tecentriq (cancer immunotherapy), Phesgo and Ocrevus as well as the launch of Elevydis (gene therapy, Duchenne muscular dystrophy). Sales in China increased by 8%, driven by Xofluza, Perjeta, Polivy and Avastin.

The Diagnostics Division sales increased by 5% to CHF 10.7 billion, while the base business (excluding COVID-19) grew by 8%. Immunodiagnostic products, which include cardiac, oncology and thyroid tests, were the main growth drivers (10%). Additional growth came from pathology and molecular solutions. Sales of COVID-19 tests were CHF 0.1 billion in the first nine months of 2024 compared with CHF 0.4 billion in the corresponding period last year.

Sales growth was reported across regions, with the Europe, Middle East and Africa (EMEA) region growing by 5%, North America by 6%, Asia-Pacific by 2% and Latin America by 18%.

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, others

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

Diagnostics: key developments

Diagnostics sales

More information on Roche sales in the first nine months of 2024:

• Q3 2024 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 pharmaceuticals with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. 

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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Attachments

• 23102024_Roche Q32023 appendix tables
• 23102024_Roche Media Release Q32024_EN