Faricimab

On January 30, Roche announced its financial results for 2024, reporting total revenue of CHF 60.495 billion (approximately $66.4 billion with a conversion rate of 1 CHF = 1.0981 USD), representing a 7% year-on-year growth. However, net income declined to CHF 9.187 billion (about $10.1 billion), a significant drop of 19%. The company invested CHF 13.042 billion (around $14.3 billion) in research and development, accounting for 21.6% of total revenue. Oncology continued to be the primary focus for R&D, along with substantial investments in immunology, cardiovascular, renal, and metabolic fields. Roche's pharmaceutical business generated CHF 46 billion (about $50.7 billion), marking an 8% increase, while the diagnostics division saw revenues of CHF 14.3 billion (approximately $15.7 billion), up 7%. The pharmaceutical segment remains the main source of Roche's profits. The company's pharmaceutical portfolio includes targeted therapies across five key areas: oncology, immunology, neuroscience, hematology, and ophthalmology. The ophthalmology sector showed remarkable growth in 2024, with sales reaching CHF 4 billion, reflecting a 44% increase. All other therapeutic areas also maintained positive growth trajectories. The drug Vabysmo (faricimab), launched in early 2022, continued to be a major growth driver, with sales of CHF 3.864 billion (about $4.243 billion) driven by increasing demand across all regions. Vabysmo is approved for three major retinal diseases, including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. Looking ahead, Roche's pipeline is robust, featuring 71 new molecular entities (NMEs) and a total of 122 projects. However, the financial report indicated that the company has reduced ten projects in Q4 2024, primarily in early development stages. Notably, Roche made significant cuts to its TIGIT antibody RG6058 pipeline, including two Phase III trials, two Phase II trials, and one Phase I trial. Several early-stage projects were also removed from the pipeline, including: A Phase I study of the FAP/4-1BB bispecific antibody RG7827 for solid tumors. A Phase I study of the HER2/CD3 bispecific antibody RG6194 for breast cancer. Additional Phase I projects targeting various solid tumors. The TIGIT monoclonal antibody RG6058, which had been the first TIGIT antibody to enter Phase III trials globally. Roche also removed two Phase II trials for the TIGIT antibody targeting metastatic head and neck squamous cell carcinoma and non-small cell lung cancer, alongside two Phase III trials. In recent updates, Roche faced setbacks with the TIGIT antibody in 2024. The SKYSCRAPER-06 study, which evaluated the combination of tiragolumab, Tecentriq, and chemotherapy against pembrolizumab and chemotherapy for locally advanced non-squamous NSCLC, did not meet its primary endpoint, showing a hazard ratio of 1.27 for progression-free survival. Currently, Roche's TIGIT antibody pipeline includes five ongoing Phase III studies, focusing on NSCLC, esophageal cancer, and liver cancer. Looking forward, Roche anticipates the potential for over seven new molecular entities with peak sales exceeding CHF 3 billion, along with four additional entities with peak sales between CHF 2 billion and 3 billion.

Roche's Susvimo was originally approved in 2021 to treat patients with wet age-related macular degeneration. Now, it has been cleared for diabetic macular edema, the major cause of diabetic-related blindness. Seven months after the FDA signed off on a reintroduction of Roche’s eye implant Susvimo, the U.S. regulator has broadened its label as a treatment for diabetic macular edema (DME), which is the leading cause of diabetes-related blindness.The nod is the second indication for Susvimo, an alternative to regular eye injections that was originally approved to treat wet age-related macular degeneration in October 2021.Twelve months later, however, Susvimo was pulled because of manufacturing problems with the seal on the port delivery device. By July of last year, Roche had ironed out the issues and earned endorsement from the FDA to put it back on the market. Susvimo is the size of a grain of rice and is surgically implanted under the upper eyelid. The device provides a customized formulation of Lucentis (ranibizumab), which needs refilling just twice a year.“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” Jordan Graff, M.D., a vitreoretinal surgeon at a Barnet Dulaney Perkins Eye Center in Arizona, said in a release.The approval is based on results from a phase 3 study of more than 600 DME patients, which showed that Susvimo accomplished noninferior improvements in vision compared to monthly doses of Lucentis. Roche has yet to reveal sales figures for Susvimo. On its first go-round on the market, the treatment had started to gain acceptance from ophthalmologists. A few months before its recall, a Spherix survey revealed that a “large majority” of eye doctors acknowledged the therapy’s “superior duration of response” compared to Regeneron and Bayer’s stalwart Eylea. Since then, Roche’s Vabysmo—which was approved in 2022—has taken the market by storm, generating sales of 3.86 billion Swiss francs ($4.3 billion) in 2024, while sales of Eylea have fallen to $5.9 billion after peaking at $6.3 billion in 2022. As for Susvimo, Roche’s pharma chief Teresa Graham said on an earnings call last week that approximately 100 implants were completed in 2024.“In this stage of the launch, it’s all about getting new ophthalmologists exposure to Susvimo and trained on how to perform the implant and refill exchange procedures,” Graham added. “This is very much a story of going slow to ultimately go fast.”DME affects approximately 29 million adults in the world, including 750,000 people in the U.S., according to Roche. It occurs when damaged blood vessels in the retina leak into and cause swelling in the macula, which is the central area of the retina responsible for the sharp vision needed for reading and driving.