10-QPeriod: Q2 FY2023

REGENERON PHARMACEUTICALS, INC. Quarterly Report for Q2 Ended Jun 30, 2023

Filed August 3, 2023For Securities:REGN

Summary

Regeneron Pharmaceuticals, Inc. (REGN) reported solid financial results for the second quarter and first half of 2023, demonstrating continued revenue growth driven primarily by Dupixent and Libtayo, which offset a decline in EYLEA sales in the US. Total revenues increased by 10.5% year-over-year for the first six months of 2023. Net income also saw an increase, reaching $1.79 billion for the first half of the year. The company's strong financial position is supported by a robust cash balance and significant investments in research and development, underscoring its commitment to pipeline expansion and innovation. The company is strategically navigating the competitive landscape for EYLEA, facing increased competition and awaiting regulatory decisions on its next-generation aflibercept 8 mg. However, the significant growth in Dupixent and Libtayo, along with progress in its robust pipeline of over 30 product candidates, positions Regeneron for sustained long-term growth. Investors should monitor upcoming regulatory decisions, especially for aflibercept 8 mg, and the continued commercial performance of key growth drivers like Dupixent.

Financial Highlights

46 data points
Beta

Revenue

$3.16B

Net Income

$968.40M

30.7% Net Margin

EPS (Diluted)

$8.50

Total Assets

$30.66B

Cash & Equivalents

$1.94B

Free Cash Flow

$1.02B

Financial Statements
Beta
Revenue$3.16B
R&D Expenses$1.09B
SG&A Expenses$652.00M
Operating Expenses$2.14B
Operating Income$1.02B
Interest Expense$18.90M
Net Income$968.40M
EPS (Basic)$9.05
EPS (Diluted)$8.50
Shares Outstanding (Basic)107.00M
Shares Outstanding (Diluted)113.90M

Key Highlights

  • 1Total revenues increased by 10.5% to $6.32 billion for the first six months of 2023 compared to the same period in 2022.
  • 2Net product sales of Dupixent increased by 35% to $5.27 billion for the first six months of 2023.
  • 3Libtayo net product sales saw a significant increase of 48% to $392.6 million for the first six months of 2023, reflecting the company's expanded global rights.
  • 4EYLEA U.S. net product sales decreased by 7% to $2.93 billion for the first six months of 2023, primarily due to increased competition.
  • 5Research and development expenses increased by 33.5% to $2.19 billion for the first six months of 2023, reflecting continued investment in pipeline development.
  • 6The company ended the period with $1.94 billion in cash and cash equivalents and $13.32 billion in marketable securities, indicating a strong liquidity position.
  • 7Regeneron announced it has $2.33 billion remaining under its authorized share repurchase program as of June 30, 2023.

Frequently Asked Questions

Regeneron's key revenue drivers in the first half of 2023 were Dupixent, which saw a 35% increase in net product sales, and Libtayo, with a 48% increase in net product sales, reflecting the company's expanded global rights. These growth drivers helped offset a decline in EYLEA's U.S. net product sales.

Regeneron received a Complete Response Letter (CRL) from the FDA for the Biologics License Application (BLA) for aflibercept 8 mg in June 2023. The CRL was solely due to unresolved observations from a third-party contract manufacturing organization inspection and did not identify issues with the product's clinical efficacy or safety. The company has resubmitted the BLA and anticipates an FDA decision by the end of the third quarter of 2023.

Effective July 1, 2022, Regeneron obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide. This transition means Regeneron now records global net product sales for Libtayo and pays Sanofi an 11% royalty on these sales through March 31, 2034. This change contributed significantly to the substantial increase in Libtayo sales reported in the first half of 2023.

Regeneron continues to invest heavily in research and development, with expenses increasing by 33.5% to $2.19 billion in the first half of 2023. This investment supports its robust pipeline of over 30 product candidates across various therapeutic areas, signaling a commitment to future growth and innovation.