ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has opened its new Pharma Research and Early Development (pRED) Center at its global headquarters in Basel, Switzerland. The center, representing a CHF 1.2 billion investment, is designed to accelerate scientific innovation and meet patient needs. It features cutting-edge technologies and houses around 1,000 state-of-the-art laboratory and office workplaces.

The facility consists of two high-rise laboratory buildings (114m and 72m) with advanced lab technologies and digital solutions, an office building, and a convention center. In total, it offers 33 combined laboratory and office floors with 150 labs and workplaces for around 1,800 researchers. This investment is part of Roche's larger commitment to the Basel/Kaiseraugst site, totaling CHF 5.8 billion from 2009 to 2030.

Roche (SIX: RO, ROG; OTCQX: RHHBY) has expanded its digital pathology open environment by integrating over 20 advanced AI algorithms from eight new collaborators. This expansion aims to enhance cancer research and diagnosis through Roche's navify® Digital Pathology enterprise software. The AI tools are designed to provide valuable insights in pathology, supporting precision medicine and targeted treatments for cancer patients.

The new collaborators include Deep Bio, DiaDeep, Lunit, Mindpeak, Owkin, Qritive, Sonrai Analytics, and Stratipath. Their algorithms cover various aspects of cancer detection and analysis, including prostate cancer grading, breast cancer biomarker quantification, and microsatellite stability screening in colorectal cancer. This integration demonstrates Roche's commitment to advancing personalized healthcare and improving patient outcomes in cancer diagnostics and treatment.

Roche has announced new 48-week data for its investigational Bruton's tyrosine kinase (BTK) inhibitor fenebrutinib from the Phase II FENopta open-label extension study in relapsing multiple sclerosis (RMS). The results, to be presented at ECTRIMS 2024, show that:

- 96% of patients were relapse-free at one year
- Annualized relapse rate (ARR) was 0.04
- No change in disability over 48 weeks (EDSS)
- 99% of patients were free of T1 gadolinium-enhancing lesions
- Three times more reduction in T2 lesion volume compared to the double-blind period

The safety profile was consistent with previous data. Three Phase III trials (FENhance 1 and 2 for RMS, FENtrepid for PPMS) are ongoing, with results expected by the end of 2025.

Roche's PiaSky (crovalimab) has received EU approval as the first monthly subcutaneous treatment for paroxysmal nocturnal haemoglobinuria (PNH) in adults and adolescents. PiaSky is a novel recycling monoclonal antibody that inhibits the complement protein C5, offering a more flexible treatment option compared to current intravenous infusions.

Key points:

• PiaSky can be self-administered, potentially reducing treatment burden
• Approval based on COMMODORE 2 study, showing equivalence to intravenous eculizumab
• Innovative recycling technology enables monthly subcutaneous administration
• Demonstrated non-inferiority and comparable safety to eculizumab
• Already approved in the US and Japan

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.