Summary
Regeneron Pharmaceuticals, Inc. (REGN) reported a strong financial performance in 2016, with revenues increasing significantly to $4.86 billion, up from $4.10 billion in 2015, and net income growing to $895.5 million, or $7.70 per diluted share, compared to $636.1 million, or $5.52 per diluted share, in 2015. This growth was primarily driven by EYLEA, which saw a 24.2% increase in U.S. net sales and remains the market-leading anti-VEGF therapy. The company also made significant advancements across its pipeline, including positive Phase 3 data for Dupixent in atopic dermatitis, with regulatory decisions pending. Key strategic initiatives included expanding research and development capabilities and forging new collaborations to bolster its drug discovery and development pipeline. The company's robust pipeline and strong commercial performance of EYLEA position it for continued growth. Key developments in 2016 include progress in multiple late-stage clinical programs, such as Praluent (positive Phase 3 data and expanded international approvals), Dupixent (positive Phase 3 data and FDA priority review), and sarilumab (though facing a Complete Response Letter for manufacturing deficiencies, the underlying data was positive). Regeneron also advanced early-stage research with collaborations in gene editing and immune-cell therapeutics, alongside substantial investment in genomics, highlighting a commitment to scientific innovation and expanding its therapeutic reach.
Financial Highlights
47 data points| Revenue | $4.86B |
| Cost of Revenue | $194.62M |
| Gross Profit | $4.67B |
| R&D Expenses | $2.05B |
| SG&A Expenses | $1.18B |
| Operating Expenses | $3.53B |
| Operating Income | $1.33B |
| Interest Expense | $7.20M |
| Net Income | $895.50M |
| EPS (Basic) | $8.55 |
| EPS (Diluted) | $7.70 |
| Shares Outstanding (Basic) | 104.70M |
| Shares Outstanding (Diluted) | 116.30M |
Key Highlights
- 1EYLEA continued its strong growth, with U.S. net sales up 24.2% in 2016 and maintaining its market-leading position in anti-VEGF therapy.
- 2Dupixent showed promising Phase 3 results for atopic dermatitis, leading to FDA acceptance for priority review with a target action date in March 2017.
- 3Praluent received regulatory approval in additional countries outside the U.S. and demonstrated positive Phase 3 data in key studies.
- 4Regeneron advanced its pipeline with 16 product candidates in clinical development, including REGN2810 entering a potentially pivotal study for cutaneous squamous cell carcinoma.
- 5The company expanded its strategic collaborations by entering into new research and development agreements with Bayer (for ocular diseases), Teva (for fasinumab), Intellia Therapeutics (for CRISPR/Cas gene-editing), and Adicet Bio (for engineered immune-cell therapeutics).
- 6Total revenues grew to $4.86 billion in 2016, and net income reached $895.5 million, or $7.70 per diluted share, reflecting significant year-over-year increases.
- 7Regeneron continued to invest in its infrastructure, hiring its 5,000th employee and expanding manufacturing operations in Rensselaer, NY, and Limerick, Ireland.