• 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.”

Sales CHF millions As % of sales % change
January‒September 2024 2023 2024 2023 At CER In CHF
Group 44,984 44,053 100.0 100.0 6 2
Pharmaceuticals Division 34,257 33,372 76.2 75.8 7 3
United States 18,166 17,430 40.4 39.6 7 4
Europe 6,613 6,259 14.7 14.2 7 6
Japan 2,083 2,937 4.6 6.7 -21 -29
International* 7,395 6,746 16.5 15.3 19 10
Diagnostics Division 10,727 10,681 23.8 24.2 5 0
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.

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*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

Compound Milestone
Regulatory
Itovebi (inavolisib)

Breast cancer

FDA approves Itovebi, a targeted treatment for advanced hormone receptor (HR)-positive, HER2-negative breast cancer with a PIK3CA mutation

  • Approval is based on phase III INAVO120 results, showing the regimen based on Itovebi (inavolisib) more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
  • This approval helps address an urgent unmet need in breast cancer for people with a mutated PIK3CA gene, one of the most commonly mutated genes in HR-positive disease and which is associated with poor prognosis
  • Itovebi is Roche's first targeted therapy approved for people with HR-positive disease, the most prevalent breast cancer subtype, marking an important step in our ambition to continue bringing innovative medicines to more people with breast cancer
 

More information: Media Release, 11 October 2024

Ocrevus Zunovo

Multiple sclerosis

FDA approves Ocrevus Zunovo as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis

  • Ocrevus Zunovo has the potential to expand treatment options to centres without intravenous (IV) infrastructure or with IV constraints, like at a doctor's office
  • This approval is backed by a decade of proven safety and efficacy data of Ocrevus IV, with over 350,000 people treated globally
  • Ocrevus Zunovo offers people with multiple sclerosis more options to access treatment based on their individual needs
 

More information: Media Release, 16 September 2024

Tecentriq Hybreza

Various types of cancer

FDA approves Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy

  • Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq
  • New subcutaneous option reduces treatment time to approximately seven minutes, compared with 30‒60 minutes for IV infusion
 

More information: Media Release, 13 September 2024

PiaSky

Rare blood disease

PiaSky approved in the EU as the first monthly subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria (PNH)

  • With the option of self-administration, PiaSky (crovalimab) has the potential to reduce treatment burden for people with PNH and their caregivers in Europe
  • Approval is based on COMMODORE 2, where subcutaneous (SC) PiaSky once a month was equivalent to intravenous eculizumab every two weeks
  • PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration
 

More information: Media Release, 27 August 2024

Vabysmo

Severe eye diseases

European Commission approves Vabysmo for treatment of retinal vein occlusion (RVO)

  • Approval is based on data from two phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept, and robust retinal drying with Vabysmo
  • Additional submitted data shows that up to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months
  • Vabysmo is already approved in several countries, including the US and Japan, for RVO and in nearly 100 countries for people with neovascular or 'wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME)
 

More information: Media Release, 30 July 2024

Phase III, pivotal and other key readouts
Evrysdi

Spinal muscular atrophy

Majority of children with spinal muscular atrophy (SMA) treated with Evrysdi are able to sit, stand and walk independently, two-year data demonstrate

  • Positive data confirm Evrysdi efficacy and safety in children first treated pre-symptomatically before six weeks of age, with most achieving motor milestones similar to children without SMA
  • All children were able to swallow and feed orally, with none requiring permanent ventilation
  • Evrysdi is the only non-invasive SMA therapy and is approved in over 100 countries, with more than 16,000 people with SMA treated globally
 

More information: Media Release, 14 October 2024

Gazyva/

Gazyvaro

Kidney disease

 

Positive phase III results for Gazyva/Gazyvaro show superiority to standard therapy alone in people with lupus nephritis

  • The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis
  • Gazyva/Gazyvaro is designed to target an underlying cause of lupus nephritis, aiming to prevent or delay progression to end-stage kidney disease
  • Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease affecting 1.7 million people worldwide, primarily women; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years
 

More information: Media Release, 26 September 2024

Xofluza

Influenza

Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses

  • Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members
  • This is the first time that any antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global phase III study
  • Reducing the spread of infection in the household could help limit transmission within communities and societies, easing the burden of both seasonal and pandemic influenza on healthcare systems
 

More information: Media Release, 19 September 2024

Fenebrutinib

Multiple sclerosis

Fenebrutinib demonstrated near-complete suppression of disease activity and disability progression for up to 48 weeks in patients with relapsing multiple sclerosis

  • New phase II data show vast majority of patients experiencing no relapses or disability progression
  • Fenebrutinib suppressed acute and chronic MRI lesions
  • Fenebrutinib's safety profile was consistent with previous and ongoing clinical trials across multiple diseases including more than 2,700 people to date
 

More information: Media Release, 4 September 2024

Susvimo

Severe eye disease

New data for Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions

  • Two-year phase III data presented at ASRS 2024 show Susvimo's potential as an alternative to eye injections to treat diabetic macular edema (DME) and diabetic retinopathy (DR)
  • Safety data were consistent with the known safety profile for Susvimo in people with DME and DR
  • Additionally, the US FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data
 

More information: Media Release, 18 July 2024

Other
Pharma Research and Early Development Center Roche opens Pharma Research and Early Development Center in Basel to accelerate scientific innovation

  • Switzerland's most innovative research and development centre underscores Roche's long-term investment in scientific advancement to meet patient needs
  • The new centre will simplify and increase collaboration, thereby accelerating scientific innovation
 

More information: Media Release, 10 September 2024

Pharmaceuticals sales

Sales CHF millions As % of sales % change
January-September 2024 2023 2024 2023 At CER In CHF
Pharmaceuticals Division 34,257 33,372 100.0 100.0 7 3
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