Roche H1 2023: Ophthalmology Bispecific Surpasses $1 Billion, Greater China Revenue Exceeds $3 Billion

On July 27, Roche announced its 2023H1 financial results, with revenue of 29.779 billion Swiss francs (approximately 32.84 billion US dollars, calculated at the 2023 average exchange rate, 1 Swiss franc = 1.1029 US dollars, hereinafter the same), a year-on-year decrease of 2% (at CER); net profit was 7.563 billion Swiss francs (8.34 billion US dollars), a year-on-year decrease of 9%; R&D investment was 6.449 billion Swiss francs, an increase of 8% year-on-year.

Pharmaceuticals business revenue: 22.681 billion Swiss francs (+8%), China region revenue: 1.505 billion Swiss francs (+3%); Diagnostics business revenue: 7.098 billion Swiss francs (-23%), China region revenue: 1.289 billion Swiss francs (+10%). The combined revenue of the two businesses in the China region is 3.08 billion US dollars.

In the pharmaceuticals segment, the oncology field remains Roche's primary focus, contributing 9.775 billion Swiss francs in revenue, although growth has slowed; business revenues in neuroscience, hemophilia A, ophthalmology, and infectious diseases all achieved double-digit growth.

Specifically, the ophthalmology product VEGF-A/Ang2 bispecific antibody Vabysmo has shown rapid growth, with sales revenue reaching 957 million Swiss francs (1.05 billion US dollars) in the first half of this year. As the first drug to achieve a 4-month dosing interval in Phase III studies for the treatment of DME and wAMD, it became a blockbuster just one year after its initial launch at the end of January 2022. In May this year, the FDA accepted its new indication for the treatment of retinal vein occlusion (RVO).

Ocrevus (ocrelizumab), Hemlibra (emicizumab), Evrysdi (risdiplam), Phesgo (trastuzumab + pertuzumab), Polivy (polatuzumab vedotin), Tamiflu (oseltamivir), and Enspryng (satralizumab) all maintained strong growth.

Ocrevus is the first drug for multiple sclerosis that covers both relapsing-remitting (RRMS) and primary progressive (PPMS) types, currently accounting for 22% of the global patient share and leading in the markets of the United States and the EU5. The Phase III OCARINA II study of its subcutaneous injection formulation was completed in July this year. Fenebrutinib, a third-generation BTK inhibitor in Roche's pipeline for treating relapsing multiple sclerosis (RMS), has achieved positive results in the first half of this year and is expected to become a complement to Ocrevus in the MS field.

Hemlibra has become the Standard of Care (SoC) for global Hemophilia A treatment, with 39% of patients in the U.S. and the EU5 already receiving treatment. In the future, Hemlibra will continue to penetrate all approved patient groups, including moderate patients.

In the first half of the year, Roche had two new drugs approved for marketing, maintaining a historical pace of new drug launches. Elevidys (delandistrogene moxeparvovec), a gene therapy jointly developed with its partner Sarepta Therapeutics, received accelerated approval from the U.S. FDA for marketing. It became the first one-time gene therapy for treating Duchenne muscular dystrophy (DMD) in patients aged 4-5. Additionally, the CD3/CD20 bispecific antibody Columvi (glofitamab), developed by Roche, also received FDA approval in the first half of this year for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) caused by follicular lymphoma who have previously received at least two lines of systemic therapy.

In the first half of the year, Roche reached two new drug co-development agreements, including the introduction of Alnylam's RNAi therapeutic drug for treating mild to moderate hypertension; and a global licensing and collaboration agreement with KSQ Therapeutics to develop a First-in-Class (FIC), selective USP1 small molecule inhibitor for the treatment of solid tumors.

However, Roche will also terminate the development of several candidate drugs, including tenecteplase for stroke indication in Phase III, RG6358 gene therapy for hemophilia A in Phase II, and four new molecular entity drugs still in Phase I research.

Looking ahead to 2023, Roche expects group sales to decline to the lower single-digit range (at constant exchange rates, CER). Excluding the impact of declining COVID-19 sales, Roche anticipates robust growth in both its pharmaceuticals and diagnostics businesses.

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