other material
confidence high
sentiment neutral
materiality 0.70
Regeneron: FY2022 EYLEA US sales $6.26B (+8%), Q4 $1.50B (-3%); expects $30M IPR&D charge
REGENERON PHARMACEUTICALS, INC.
- FY2022 EYLEA US net product sales ~$6.26B (+8% YoY); Q4 2022 ~$1.50B (-3% YoY).
- Q4 EYLEA negatively impacted by short-term shift to off-label compounded Avastin and temporary closure of co-pay assistance fund; reversal beginning per Dec 2022 market data.
- Expects ~$30M IPR&D charge from CytomX collaboration, reducing Q4 2022 GAAP/non-GAAP diluted EPS by ~$0.21.
- Aflibercept 8 mg BLA submitted for wAMD and DME using priority review voucher; potential FDA approval by late August 2023.
- Dupixent approved in 2022 for AD infants (6mo-5yr), EoE, prurigo nodularis; sBLA submitted for CSU in biologic-naïve patients.