Roche has announced a robust 6% increase in Group sales for the first nine months of 2024, with a notable 9% growth in the third quarter. This growth is fueled by strong demand for both pharmaceutical and diagnostic products. The company has also achieved significant regulatory milestones, including FDA approvals for Itovebi, Ocrevus Zunovo, and Tecentriq Hybreza, and positive Phase III data across multiple therapeutic areas.
Pharmaceuticals Division Performance
The Pharmaceuticals Division experienced a 7% sales increase, driven by strong performance of key products such as Vabysmo (for severe eye diseases), Phesgo (for breast cancer), and Ocrevus (for multiple sclerosis). These medicines contributed significantly to the 9% growth in the division's base business, reflecting the demand for innovative treatments for severe diseases. Specifically, these five medicines generated total sales of CHF 13.2 billion, an increase of CHF 2.7 billion (CER) from the first nine months of 2023.
Key Regulatory Approvals
Roche secured several important regulatory approvals in the United States:
- Itovebi (inavolisib): Approved for advanced hormone receptor (HR)-positive, HER2-negative breast cancer with a PIK3CA mutation. The approval was based on Phase III INAVO120 results, demonstrating a significant improvement in progression-free survival.
- Ocrevus Zunovo: Approved as the first and only twice-a-year 10-minute subcutaneous injection for relapsing and progressive multiple sclerosis.
- Tecentriq Hybreza: Approved as the first and only subcutaneous anti-PD-(L)1 cancer immunotherapy, offering a reduced treatment time of approximately seven minutes compared to 30-60 minutes for IV infusion.
In Europe, Vabysmo was approved for retinal vein occlusion (RVO), and PiaSky was approved for paroxysmal nocturnal haemoglobinuria (PNH).
Clinical Trial Advancements
Several Roche products have shown promising results in clinical trials:
- Gazyva/Gazyvaro: Positive Phase III results in the REGENCY study demonstrated superiority to standard therapy alone in patients with lupus nephritis. The study met its primary endpoint, showing statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis.
- Xofluza: Phase III CENTERSTONE study showed that single-dose Xofluza significantly reduces the transmission of influenza viruses.
- Fenebrutinib: New Phase II data demonstrated near-complete suppression of disease activity and disability progression for up to 48 weeks in patients with relapsing multiple sclerosis.
- Evrysdi: Two-year 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.
Diagnostics Division Performance
The Diagnostics Division reported a 5% increase in sales, with the base business growing by 8%. Immunodiagnostic products were the main growth drivers, with additional contributions from pathology and molecular solutions. Sales growth was reported across all regions, with particularly strong performance in Europe, the Middle East, Africa, and North America.
Strategic Acquisitions and Partnerships
Roche has also been active in strategic acquisitions, including AntlerA Therapeutics for ophthalmology and an agreement to acquire two next-generation CDK inhibitor drugs from Regor Pharmaceuticals, strengthening its oncology and ophthalmology pipelines. The company also closed the acquisition of LumiraDx’s point-of-care technology to expand access to diagnostic testing in primary care and low- and middle-income countries.
Outlook
Roche confirms its outlook for 2024, expecting an increase in Group sales in the mid-single-digit range (CER) and targeting core earnings per share growth in the high-single-digit range (CER), excluding the impact from the resolution of tax disputes in 2023.
