Regeneron Reports H1 2023 Revenue of $6.32 Billion and Anticipates Q3 Approval for Eylea 8mg

On August 3, Regeneron announced its H1 2023 financial results, reporting a total revenue of $6.32 billion in the first half of the year, representing an 8.6% increase year-over-year; R&D investment reached $2.187 billion, marking a 33.5% year-over-year growth.

Regeneron's revenue mainly comes from two segments: product sales and collaboration revenue. The collaboration revenue totaled $2.695 billion (+18.4%), coming from Sanofi ($1.742 billion, +33.1%), Bayer ($734 million, -1%), and Roche ($222 million, -1%). Product sales brought Regeneron a total revenue of $3.44 billion (+1.4%).

Eylea (Aflibercept), co-developed by Regeneron and Bayer, generated a total revenue of $4.667 billion in H1 2023, representing a 4% year-over-year decline. Sales in the U.S. amounted to $2.934 billion (-6.5%, exclusively held by Regeneron), while sales in markets outside the U.S. reached $1.733 billion.

In June 2023, the FDA rejected the marketing application for aflibercept 8mg formulation due to issues with a third-party filler. Regeneron disclosed in its earnings report that it would resubmit data to the FDA in mid-August, with approval expected before the end of the third quarter.

Dupixent (dupilumab), jointly developed by Regeneron and Sanofi, is globally commercialized by Sanofi. Currently, dupilumab has been approved worldwide for five indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and eosinophilic esophagitis. In the first half of 2023, dupilumab's sales reached a total of $5.274 billion, with a growth rate of 35%, and it is expected to surpass the $10 billion mark by the end of the year. With ongoing market penetration, expansion into new indications, and coverage of younger patient groups, dupilumab shows strong potential for continued growth.

Multiple clinical trials have shown that IL-4 and IL-13 are key drivers of various type 2 allergic diseases, indicating that dupilumab has the potential to benefit patients with a range of type 2 allergic conditions, with unlimited potential in its future product pipeline.

In the field of oncology, Regeneron's PD-1 inhibitor Libtayo (Cemiplimab) achieved a 48% growth to US$393 million in H1 2023. Currently, Regeneron is conducting clinical research on various combination therapies involving Libtayo with mono- and bispecific antibodies, such as anti-LAG-3 antibody, anti-GITR antibody, EGFRxCD28 bispecific antibody, MUC16xCD3 bispecific antibody, and BCMAxCD3 for the treatment of different types of tumors.

REGN5678 is a PSMAxCD28 bispecific antibody targeting advanced prostate cancer. In clinical studies combined with Libtayo, two cases of immune-mediated Grade 5 adverse events (death) have occurred, one of which happened in July 2023. Currently, patient enrollment in the study has been halted. Regeneron stated that it plans to continue exploring the therapeutic potential of REGN5678 in combination with a lower dose of Libtayo, REGN5678 as monotherapy, and in combination with other immunotherapies.

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