Roche Hldg Stock Price, News & Analysis

Roche has announced its support for the global response to the mpox outbreak, declared a Public Health Emergency of International Concern by the WHO on August 14, 2024. The company is providing high-quality PCR testing and working to enhance laboratory capacity worldwide. Roche has developed three LightMix® Modular Virus kits and the cobas® MPXV test to detect the mpox virus, confirming that these tests can identify the latest variants.

Matt Sause, CEO of Roche Diagnostics, emphasized the importance of diagnostics in addressing public health challenges like mpox. Roche is partnering with governments, healthcare providers, and organizations to combat the outbreak, and is providing training for laboratories across Africa at the Roche Scientific Campus in South Africa and locally.

Roche's Vabysmo has received European Commission approval for treating visual impairment due to macular edema secondary to retinal vein occlusion (RVO). This marks Vabysmo's third indication in the EU, alongside neovascular age-related macular degeneration and diabetic macular edema. The approval is based on Phase III BALATON and COMINO studies, which showed Vabysmo's non-inferior efficacy to aflibercept in vision improvement and superior retinal drying.

Key highlights:

• Up to 60% of patients could extend treatment intervals to 3-4 months
• Vabysmo is the first bispecific antibody for eye treatments
• Already approved in nearly 100 countries for various retinal conditions
• Over 4 million doses distributed globally

Roche has completed the acquisition of LumiraDx's Point of Care technology, following all required clearances. This acquisition enhances Roche's diagnostics portfolio with a multi-assay platform that consolidates various tests on a single instrument. The integration aims to expand global access to decentralised diagnostic testing, particularly in primary care and low/middle-income countries.

Key points:

• LumiraDx's technology complements Roche's offerings across multiple disease areas
• The platform allows for future expansion into molecular testing
• Roche will continue partnering with the Bill & Melinda Gates Foundation to develop a rapid point-of-care molecular tuberculosis test
• The acquisition addresses the global need for accessible diagnostics, particularly in underserved areas

Roche reported a 5% increase in sales at constant exchange rates (CER) in the first half of 2024, with Group sales reaching CHF 29.8 billion. Growth was driven by high demand for medicines and diagnostics, excluding COVID-19 products, which saw an 8% sales increase.

Pharmaceuticals Division sales rose by 5%, propelled by medicines like Vabysmo, which generated CHF 1.8 billion. Diagnostics Division sales also increased by 5%, with significant demand for immunodiagnostic products.

Core operating profit grew by 11%, and core earnings per share increased by 9%. However, IFRS net income declined by 4% due to asset impairments and litigation provisions base effects from 2023.

Roche raised its full-year earnings outlook and expects mid-single-digit Group sales growth and high-single-digit core EPS growth at CER. The company received multiple regulatory approvals, including EU approval for Alecensa and Ocrevus.

Roche (RHHBY) announced two-year data from Phase III Pagoda and Pavilion studies evaluating Susvimo for treating diabetic macular edema (DME) and diabetic retinopathy (DR). Susvimo, a refillable eye implant, demonstrated sustained efficacy over two years with safety consistent with its known profile. The US FDA accepted Roche's sBLA for Susvimo in DME and DR based on one-year study data.

Key findings include:

• DME patients maintained vision gains (9.8 eye chart letters) at two years
• 95% of DME patients didn't need additional injections
• 80% of DR patients achieved significant DRSS improvements at two years
• 98% of DR patients didn't require supplemental injections

Susvimo could potentially offer a new treatment paradigm for diabetic eye diseases, reducing the need for frequent injections.

Genentech, a Roche Group member (OTCQX: RHHBY), announced two-year data from Phase III Pagoda and Pavilion studies evaluating Susvimo for diabetic macular edema (DME) and diabetic retinopathy (DR). Susvimo, a refillable eye implant, demonstrated sustained efficacy over two years with consistent safety profile. Key findings include:

- DME: Maintained vision gains (9.8 eye chart letters) at two years
- DR: 80% achieved two-step or greater improvement on DRSS at 100 weeks
- 95-98% of patients didn't need additional injections
- FDA accepted sBLA for Susvimo in DME and DR based on one-year data

If approved, Susvimo could offer a new treatment paradigm for diabetic eye diseases, potentially reducing the frequency of eye injections.

Genentech, a Roche Group member, announced four-year data from the RHONE-X extension study for Vabysmo (faricimab-svoa) in treating diabetic macular edema (DME). The study met all primary endpoints, demonstrating Vabysmo's consistent safety profile. Key findings include:

- Over 90% of patients showed absence of DME after four years
- Nearly 80% of patients received treatment at 3-4 month intervals
- Sustained vision gains and anatomical improvements were observed
- Vabysmo maintained efficacy in preserving vision and drying retinal fluid

This represents the largest long-term extension dataset in DME, reinforcing Vabysmo's potential as a standard treatment for the 29 million people affected worldwide. Vabysmo is currently approved in nearly 100 countries for DME and wet AMD.

Roche announced four-year data from the RHONE-X extension study for Vabysmo (faricimab) in treating diabetic macular edema (DME). The study met all primary endpoints, demonstrating Vabysmo's consistent safety profile. Key findings include:

- Over 90% of patients showed absence of DME after four years
- Nearly 80% of patients received treatment at 3-4 month intervals
- Sustained vision gains and anatomical improvements were observed
- Vabysmo continued to preserve vision and dry retinal fluid

This is the largest long-term extension dataset in DME to date, reinforcing Vabysmo's potential as a standard of care treatment for the 29 million people affected by DME worldwide.

Genentech, a Roche Group member, announced positive Phase I results for CT-996, an oral GLP-1 receptor agonist for obesity treatment. After four weeks, CT-996 demonstrated a clinically meaningful weight loss of -7.3% compared to -1.2% with placebo. The safety profile was consistent with other oral GLP-1 agonists, with no unexpected safety signals.

Key findings include:

• Placebo-adjusted mean weight loss of -6.1% within four weeks
• Once-daily oral dosing regimen supported by pharmacokinetic data
• Potential for dosing without regard to meal timing
• Well-tolerated with mostly mild to moderate gastrointestinal-related adverse events

This marks the second positive readout from Genentech's metabolic pipeline in less than three months, following data for CT-388.