Roche released its earnings for the first nine months of 2025, which saw its pharmaceutical revenues increase by 9% at constant exchange rates. Its top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of nearly $20 billion. Will momentum continue?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Top growth drivers
Although facing headwinds due to exchange rate fluctuations, Roche achieved sales growth in its Pharmaceuticals Division of 9% at constant exchange rates (CER) (4% in Swiss francs) to CHF 35.6 billion ($44.7 billion) for the first nine months of 2025 (January to September 2025). The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on sales when reported in Swiss francs compared to constant exchange rates. The US accounted for nearly 53% of the company’s pharmaceutical sales in the first nine months of 2025.

On a product basis, the company reported that its top five growth drivers—Phesgo (pertuzumab, trastuzumab, and hyaluronidase), Xolair (omalizumab), Hemlibra (emicizumab-kxwh), Vabysmo (faricimab-svoa), and Ocrevus (ocrelizumab) achieved total sales of CHF 15.8 billion ($19.9 billion). This represents an increase of CHF 2.4 billion ($3.0 billion) at CER compared to the first nine months of 2024.

All of these drugs are biologics and represent the drugs with the highest year-over-year growth for the company. Phesgo is a combination therapy for treating certain forms of HER2-positive breast cancer and is positioned as a next-generation therapy consisting of the active pharmaceutical ingredients (APIs) used in two other breast cancer drugs by Roche that face biosimilar competition—pertuzumab, the API in Roche’s Perjeta, and trastuzumab, the API in Roche’s Herceptin—and hyaluronidase, which is used to increase the dispersion and absorption of these co-administered drugs via subcutaneous drug delivery. Phesgo posted sales for the first nine months of 2025 of CHF 1.8 billion ($2.3 billion), a 54% increase year over year.

An older drug, Xolair (omalizumab) is used to treat moderate-to-severe allergic asthma, chronic hives, nasal polyps, and certain food allergies, It was first approved in 2003 for its first indication for treating moderate-to-severe asthma with subsequent approvals for the other indications. Although facing biosimilar competition, the drug posted sales in the first nine months of 2025 of CHF 2.2 billion ($2.8 billion), a 34% increase year over year, led by its indication for certain food allergies.  

Hemlibra (emicizumab-kxwh) is used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes from hemophilia A, a genetic bleeding disorder caused by a deficiency in the clotting Factor VIII. It posted sales in the first nine months of 2025 of CHF 3.5 billion ($4.4 billion), a 12% increase year over year.

Vabysmo (faricimab-svoa) is used to treat age-related macular degeneration, diabetic macular edema, and macular edema from retinal vein occlusion. It posted sales in the first nine months of 2025 of CHF 3.1 billion ($3.9 billion), a 13% increase year over year.

Ocrevus (ocrelizumab) was Roche’s top-selling drug overall in the first nine months of 2025, posting sales of CHF 5.2 billion ($6.5 billion), a 7% increase year over year. It is used to treat relapsing forms of multiple sclerosis.

Pipeline potential
Longer term, Roche has identified up to 19 new molecular entities (NMEs) with launch potential by 2030, with 10 NMEs entered or entering Phase III studies in 2025/2026. These 10 NMEs are:

• NXT007 in hemophilia A (Phase III to initiate in 2026);

• cevostamab in relapsing/remitting multiple myeloma (Phase III to initiate in 2026);

• a human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitor in HER2-positive breast cancer (Phase II/III to initiate in 2026);

• trontinemab in Alzheimer’s disease (Phase III initiated in September 2025);

• prasinezumab in Parkinson’s disease (Phase III to initiate in fourth quarter 2025);

• zosurabalpin in multi-drug-resistant bacterial infections (Phase III to initiate in 2026);

• zilebesiran in hypertension (Phase III initiated in September 2025);

• CT-388 in obesity (Phase III to initiate in first half 2026);

• CT-868 in Type 1 diabetes (Phase III to initiate in 2026); and  

• pegozafermin in metabolic dysfunction-associated steatohepatitis (MASH) (Phase III ongoing).

These NMEs in or entering late-stage development are as a result of both in-house development by Roche or gained by the company through partnering deals or acquisitions.

NXT007 was engineered by Chugai, a member of the Roche Group, and built on the framework of Roche’s Hemlibra (emicizumab) with the aim of optimizing factor VIII-mimetic activity and half-life, to further enhance potency, efficacy, dosing and administration convenience. Cevostamab, a T-cell engaging bispecific antibody was developed in-house by Roche for treating relapsing/remitting multiple myeloma. Trontinemab is an investigational bispecific antibody developed with Roche’s proprietary Brainshuttle technology combining an amyloid beta-binding antibody with a transferring receptor (TfR1) shuttle module. Trontinemab is designed for the efficient transport across the blood-brain barrier to target aggregated forms of amyloid beta and remove amyloid plaques in the brain.

Roche is partnered with Prothena, a Dublin, Ireland-based bio/pharmaxeutical company developing drugs based on protein dysregulation, for prasinezumab for treating early-stage Parkinson’s disease. Roche entered into a licensing, development, and commercialization agreement with Prothena in December 2013 to develop and commercialize monoclonal antibodies targeting aggregated alpha-synuclein, such as prasinezumab, for the treatment of Parkinson’s disease.

Zosurabalpin, discovered by researchers at Harvard University and developed with Roche, is a antibiotic for treating carbapenem-resistant Acinetobacter baumannii (CRAB) infections, a difficult-to-treat or resistant bacteria typically acquired in hospital and clinical settings.

Roche is partnered with Alnylam Pharmaceuticals, a Cambridge, Massachusetts-based bio/pharmaceutical company for zilebesiran, an investigational biannual subcutaneously administered RNAi therapeutics to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension. The companies formed a strategic collaboration in 2023 to develop and commercialize zilebesiran in deal worth up to $2.8 billion.

Roche gained CT-388 in obesity and CT-869 in Typle I diabetes through its 2024 acquisition of Carmot Therapeutics, a Berkeley, California-based bio/pharmaceutical company, in a deal worth up to $3.1 billion ($2.7 billion at closing plus $400 million in potential milestone payments). The acquisition provided Roche with three clinical-stage assets with potential in treating obesity and diabetes. These included CT-996, a once-daily oral small-molecule GLP-1 receptor agonist, in Phase I, for treating obesity in patients with and without Type 2 diabetes, as well as two injectable clinical drug candidates: CT-388, a once-weekly subcutaneous injectable for treating obesity in patients with and without Type 2 diabetes, and CT-868, a once-daily subcutaneous injectable, in Phase II, for treating Type 1 diabetes patients with overweight or obesity.

In liver disease, Roche is gaining pegozafermin through its acquisition of 89bio, a clinical-stage bio/pharmaceutical company focused on the treatment of liver and cardiometabolic diseases, in a deal worth up to $3.5 billion. 89bio’s lead asset, pegozafermin, is a FGF21 analog currently in late-stage development for treating metabolic dysfunction-associated steatohepatitis (MASH) in moderate and severe fibrotic patients (F2 and F3 stages) as well as cirrhotic patients (F4 stage).