10-KPeriod: FY2022

REGENERON PHARMACEUTICALS, INC. Annual Report, Year Ended Dec 31, 2022

Filed February 6, 2023For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) reported revenues of $12.17 billion for the year ended December 31, 2022, a decrease of approximately 24% compared to $16.07 billion in 2021. This decline was primarily driven by a significant drop in REGEN-COV sales, which were $7.57 billion in 2021 and largely absent in 2022, coupled with a modest increase in EYLEA and Dupixent sales. Net income also decreased substantially from $8.08 billion in 2021 to $4.34 billion in 2022, reflecting the reduced revenues and increased investment in research and development. The company continues to invest heavily in its robust pipeline, with research and development expenses increasing by approximately 25% year-over-year. Key products like EYLEA and Dupixent showed growth, indicating strong performance in core therapeutic areas. Regeneron is also actively managing its capital, evidenced by significant share repurchases and capital expenditures aimed at expanding its manufacturing capacity. The company remains focused on innovation and the development of new therapies across a broad range of serious diseases.

Financial Statements
Beta
Revenue$12.17B
R&D Expenses$3.59B
SG&A Expenses$2.12B
Operating Expenses$7.43B
Operating Income$4.74B
Interest Expense$59.40M
Net Income$4.34B
EPS (Basic)$40.51
EPS (Diluted)$38.22
Shares Outstanding (Basic)107.10M
Shares Outstanding (Diluted)113.50M

Key Highlights

  • 1Total revenues for the year ended December 31, 2022, were $12.17 billion, a decrease from $16.07 billion in 2021, primarily due to the substantial decline in REGEN-COV sales.
  • 2Net income for the year was $4.34 billion, down from $8.08 billion in 2021.
  • 3EYLEA net product sales in the U.S. increased to $6.26 billion from $5.79 billion in 2021.
  • 4Dupixent's contribution, reported as collaboration revenue from Sanofi, increased to $2.86 billion in 2022 from $1.90 billion in 2021.
  • 5Libtayo net product sales increased, with the company now solely responsible for worldwide commercialization following an agreement with Sanofi.
  • 6Research and development expenses increased to $3.59 billion in 2022 from $2.86 billion in 2021, reflecting continued investment in pipeline development.
  • 7The company repurchased $2.10 billion of its common stock in 2022, continuing its capital return strategy.

Frequently Asked Questions

Regeneron's primary revenue sources in 2022 were EYLEA (U.S. sales of $6.26 billion) and collaboration revenue from Dupixent via Sanofi ($2.86 billion). While EYLEA saw a modest increase in U.S. sales and Dupixent collaboration revenue grew significantly, total revenues decreased by approximately 24% year-over-year to $12.17 billion. This decline was largely attributed to the absence of substantial REGEN-COV sales in 2022, compared to $7.57 billion in 2021.

Regeneron's profitability saw a significant decline in 2022. Net income fell to $4.34 billion from $8.08 billion in 2021, representing a decrease of approximately 46%. This reduction in net income was primarily driven by the lower overall revenues and increased investments in research and development.

Regeneron maintains a strong focus on innovation and has a robust pipeline of approximately 35 product candidates in clinical development. The company continues to invest heavily in research and development, as evidenced by the increase in R&D expenses to $3.59 billion in 2022. Key growth drivers include EYLEA and Dupixent, with ongoing efforts to expand indications and develop next-generation treatments. The company is also strategically expanding its manufacturing capabilities and continuing its share repurchase program.

The Emergency Use Authorization for REGEN-COV was revised in January 2022 to exclude its use against Omicron-lineage variants, and the FDA issued a complete response letter for the Biologics License Application in December 2022. Consequently, REGEN-COV sales were negligible in 2022. The company is developing 'next generation' COVID-19 antibodies, but the future commercial impact of these is uncertain.