Summary
Regeneron Pharmaceuticals, Inc. (REGN) has filed a Form 8-K to disclose an expected $100 million pre-tax acquired in-process research and development (IPR&D) charge for the third quarter of 2023. This charge is primarily related to a development milestone payment for the Phase 1 ALN-APP program in early-onset Alzheimer's disease, stemming from Regeneron's collaboration with Alnylam Pharmaceuticals, Inc. This IPR&D charge is anticipated to reduce both GAAP and non-GAAP net income per diluted share by approximately $0.78 for the quarter. While this charge will impact reported earnings, it represents a milestone achievement in the company's research pipeline. Regeneron notes that these IPR&D charges are inherently unpredictable in timing and magnitude and are therefore not typically forecasted.
Key Highlights
- 1Expected $100 million pre-tax IPR&D charge for Q3 2023.
- 2Charge related to a development milestone for the ALN-APP program (early-onset Alzheimer's disease).
- 3Milestone achieved in Phase 1 of the ALN-APP program through collaboration with Alnylam Pharmaceuticals.
- 4Estimated $0.78 reduction in GAAP net income per diluted share for Q3 2023.
- 5Estimated $0.78 reduction in non-GAAP net income per diluted share for Q3 2023.
- 6Regeneron does not forecast IPR&D charges due to their inherent uncertainty.
- 7Q3 2023 results are preliminary and subject to financial statement closing procedures.