Bayer Submits Marketing Application for Aflibercept 8mg in China Amid H1 2023 Financial Results

On August 8, Bayer announced its H1 2023 performance, with revenue in the first half of the year reaching €25.433 billion (approximately $27.582 billion, calculated at the average exchange rate of 1 euro = 1.0845 USD in 2023, same below), representing a year-on-year decrease of 4.5%. Of this, pharmaceutical business revenue was €8.964 billion (approximately $9.721 billion), marking a year-on-year decrease of 1.4%; Crop Science business revenue amounted to €13.275 billion (approximately $14.397 billion), reflecting a year-on-year decline of 8.6%; Consumer Health business revenue reached €3.039 billion (approximately $3.296 billion), showing a year-on-year increase of 4.7%.

Bayer's pharmaceutical business segment mainly relies on two products for revenue: Xarelto (Rivaroxaban) and Eylea (Aflibercept). Due to the expiration of the core patent of Rivaroxaban in China and the impact of centralized procurement, its sales have started to decline (€1.982 billion, -8.0%). Thanks to Aflibercept’s continued penetration in the ophthalmology field and its newly approved indication for retinopathy of prematurity, the product’s sales are still growing (€1.603 billion, +5.1%).

However, the Chinese patent for Aflibercept expired in 2020, the U.S. patent expired in 2021, and the EU patent is set to expire in 2025. The product's sales will face competition from multiple generic drugs in the future. To address this challenge, Bayer and Regeneron have developed a higher-dose version (8mg) of Aflibercept and have already submitted its marketing application in the EU, the U.S., and China. It is slightly regrettable that last month, the FDA refused to approve the formulation for marketing on the scheduled date due to issues with a third-party filling agent. Regeneron is already addressing the issue and will resubmit the marketing application by mid-August.

Among the 15 best-selling products, Nubeqa (darolutamide) and Kerendia (finerenone) have seen significant sales growth, increasing by 110.2% and 289.7%, respectively. The growth of darolutamide is mainly due to the expansion of its indications to include hormone-sensitive prostate cancer, while finerenone's growth is attributed to its expanded use in patients with early diabetic nephropathy.

In view of the less optimistic performance in the first half of the year (mainly in the crop science business), Bayer also lowered its full-year sales forecast from €51-52 billion to €48.5-49.5 billion.

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