8-KEarnings & Results

REGENERON PHARMACEUTICALS, INC. 8-K Report, Financial Results (Oct 5, 2023)

Filed October 5, 2023For Securities:REGN

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.

Frequently Asked Questions

The charge is due to a development milestone payment for the ALN-APP program, which is in Phase 1 for early-onset Alzheimer's disease. This milestone was achieved as part of Regeneron's collaboration with Alnylam Pharmaceuticals.

Regeneron expects this $100 million charge to reduce both GAAP and non-GAAP net income per diluted share by approximately $0.78 for the third quarter of 2023.

Regeneron does not forecast acquired IPR&D charges because the future occurrence, magnitude, and timing of these transactions are inherently uncertain and difficult to predict.

No, Regeneron's results for the third quarter of 2023 have not been finalized and are subject to the company's financial statement closing procedures. Actual results could differ from these preliminary estimates.