Regeneron is fighting some serious enemies. Regeneron Pharmaceuticals develops protein-based drugs used to battle a variety of diseases and conditions, including cancer, high cholesterol, inflammatory ailments, and eye diseases. The biotechnology company has a handful of products on the market, including eye disease treatment EYLEA (aflibercept), cholesterol lowering drug Praluent, rare inflammatory disease treatment ARCALYST, rheumatoid arthritis drug Kevzara, and cancer treatment ZALTRAP. Regeneron has 15 more candidates in clinical development.
Regeneron operates in one business segment which includes all activities from discovery and development through commercialization of its pharmaceutical products. Most of the segment's revenue comes from EYLEA sales, followed by ARCALYST sales. The company also has development candidates in areas including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. This segment brings in more than 60% of total revenue.
The rest of the company's revenue comes from development collaborations. Regeneron has collaborations with Sanofi and Bayer HealthCare to develop aflibercept for additional indications including cancerous tumors, as well as obtain approvals outside of the US. The company also has a partnership with Teva to develop fasinumab for chronic pain in patients with osteoarthritis. And in mid-2018 it established two new partnerships that employ Regeneron's antibody technology platform. It is collaborating with Zoetis to discover new veterinary treatments, and with bluebird bio to develop new cell therapies for cancer.
Regeneron has its corporate and R&D headquarters in Tarrytown, New York, and a satellite office in Basking Ridge, New Jersey. It manufactures bulk drug materials in Renssalaer, New York, and has additional office space in Sleepy Hollow and Troy, New York.
Internationally, Regeneron is headquartered in Dublin, Ireland, and has a manufacturing facility in Limerick, Ireland, as well as an office in London.
Sales and Marketing
Regeneron uses distributors and specialty pharmacies to sell its products directly to health care providers. ARCALYST is sold directly to patients.
The company's largest customers are AmerisourceBergen subsidiary Besse Medical, McKesson, and Express Scripts subsidiary Curascript SD Specialty Distribution. They account for virtually all gross product revenue. Regeneron also collaborates with Bayer and Sanofi for global sales of EYLEA, Dupixent, Praluent, and Keyzara.
Thanks to the launching of about a half-dozen products since 2011, Regeneron has reported strong revenue growth over the last few years. Net income has also been rising steadily.
In 2017 revenue increased 21% to $5.9 billion, thanks primarily to higher sales of EYLEA and higher collaboration revenue from Sanofi and Bayer. Overall, net product sales increased 11% that year.
With that higher revenue, net income rose 34% to $1.2 billion in 2017. Higher sales of EYLEA helped fund activities, such as an expansion of manufacturing capabilities, to support the company's other product candidates.
The company ended 2017 with $812.7 million in net cash, nearly $300 million more than it had at the end of 2016. This was largely due to operating cash inflow totaling $1.3 billion. Investing activities, primarily the purchases of investment securities, used $1 billion and financing activities used $24.4 million.
Regeneron has expanded the applications of its protein-based technology to include the creation of human monoclonal antibodies (laboratory-produced cloned proteins). It has a pipeline of 15 clinical-stage antibodies with programs in eye disease, infectious disease, cancer, pain management, cardiovascular disease, and inflammation. The company also licenses its human antibody technology out to drug developers, who then use Regeneron's technology in researching their own antibody drugs.
With its development partners, Regeneron has been successful in obtaining expanded approvals for its existing products. In late 2018, Sanofi and Regeneron won US approval for Dupixent as an asthma treatment, adding to its previously approved use for dermatitis. Dupixent is expected to reach blockbuster status, and the asthma indication will only help boost its sales. However, Dupixent for asthma has a relatively high list price of $36,000 per year, and it faces competition from other drugs.
Also in 2018, Sanofi and Regeneron's Libtayo received FDA clearance to treat patients with metastatic cutaneous squamous cell carcinoma (CSCC, which accounts for about 20% of skin cancer cases) who are not candidates for curative surgery or radiation. Libtayo is also under review in Europe.
Regeneron faces competition from Novartis, which is hoping to launch its EYLEA competitor in 2019. Novartis' RTH258 is not yet approved by the FDA, but it has shown to perform better than EYLEA in clinical trials.
In 2017 and 2016, Regeneron spent $2.1 billion on R&D expenses, up from $1.6 billion in 2015.
Regeneron was founded in New York City in 1988.
ARCALYST (rilonacept) was approved by the FDA in 2008 and subsequently became the company's first market-stage product.
777 Old Saw Mill River Rd STE 10
Tarrytown, NY 10591-6707
Phone: 1 (914) 847-7000
Employer Type: Publicly Owned
Stock Symbol: REGN
Stock Exchange: , NASDAQ
SVP Finance and CFO: Robert E. Landry
President and CEO: Leonard S. Schleifer
Chairman: P. Roy Vagelos
Employees (This Location): 277
Employees (All Locations): 7,400