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's first commercialized product is ARCALYST, a treatment for rare inflammatory diseases including Muckle-Wells Syndrome. Regeneron collaborates with Sanofi to develop candidate aflibercept (VEGF Trap) as a possible treatment for cancerous tumors. It is also developing aflibercept with Bayer HealthCare to treat eye diseases using intraocular delivery, with EYLEA approved in the US and Australia as a treatment of neovascular age-related macular degeneration (wet AMD).
The company operates in one business segment which includes all activities from discovery and development through commercialization of its pharmaceutical products. It has development candidates in areas including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis.
The company and Sanofi globally collaborate on the development and commercialization of ZALTRAP (to treat patients with metastatic colorectal cancer), and share profits and losses from commercialization of ZALTRAP, except for Japan.
Sanofi has committed to pay up to $160 million per year, or a total of $1.28 billion, between 2010 and 2017 to fund its efforts to identify and validate drug discovery targets and preclinically develop fully human monoclonal antibodies against such targets. Antibody-based clinical programs in collaboration with Sanofi include PRALUENT, Antibody to PCSK9; Sarilumab (REGN88); Dupilumab (REGN668); REGN1033; and REGN2222.
Regeneron has a non-exclusive license to certain patents relating to VEGF receptor proteins.
In addition, in 2014 the FDA, European Commission, and Japanese Ministry of Health, Labour and Welfare approved EYLEA for the treatment of diabetic macular edema (DME).
Regeneron has its corporate and research & development headquarters in New York, and a satellite office in New Jersey. It manufactures bulk drug materials in Renssalaer, New York. Internationally, it is headquartered in Dublin, Ireland, and has a manufacturing facility (under construction) in Limerick.
Sales and Marketing
Research and development expenses accounted for some 40% of Regeneron's revenues in 2015.
Regeneron has reported strong revenue growth trend over the last few years. In 2015 its revenues increased 46% to $4.1 billion due to higher product sales (particularly EYLEA net sales) and Sanofi collaboration reimbursements.
Net income, which has been fluctuating, rose 88% to $636.1 million in 2015, primarily as a result of Regeneron's increased revenue that year. Decreases in interest expenses and losses on extinguishment of debt also helped boost profits.
Cash flow from operations also rose that year, gaining 77% to reach $1.3 billion.
The company 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 a dozen clinical-stage antibodies with programs in eye disease, infectious disease, cancer, pain management, cardiovascular disease, and inflammation.
Outside of their partnership on aflibercept, Regeneron has an antibody development agreement with Sanofi that includes $475 million in potential milestone payments and covers potential treatments for ailments including cancer, rheumatoid arthritis, pain, cholesterol, and allergic conditions.
As its largest partner, Sanofi (which also owns a 20% stake in Regeneron) accounts for about 20% of sales. The company's other collaborations account for more than 15% of sales; firms are working together to treat ophthalmic diseases including diabetic macular edema and wet age-related macular degeneration.
The company also licenses its human antibody technology out to drug developers, who then use Regeneron's technology in researching their own antibody drugs. Licensing partners include AstraZeneca and Astellas Pharma.
In 2015 the EYLEA injection was approved by the European Commission for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion.
In 2014 Regeneron entered into an agreement with Bayer HealthCare governing the joint development and commercialization outside the US of an antibody product candidate to PDGFR-beta, including in combination with EYLEA, for the treatment of ocular diseases or disorders. That year it signed a similar deal with Adverum Biotechnologies, to discover, develop, and commercialize novel gene therapy products for the treatment of ophthalmologic diseases.
The company launched a new human genetics initiative in 2014 via a wholly owned subsidiary, Regeneron Genetics Center.
In 2015, Regeneron spent $1.6 billion on R&D expenses, up from $1.3 billion spent in 2014.
In 2012 Regeneron and Bayer HealthCare converted their 50-50 global profit-share agreement for marketing EYLEA (aflibercept) Injection as a treatment for wet AMD outside the US into a royalty arrangement in Japan, where approval for the treatment is pending authorization. Applications for marketing EYLEA have been submitted by Bayer HealthCare in Europe and other countries. The treatment is also in Phase 3 clinical studies for other indications including diabetic macular edema, myopic choroidal neovascularization, and branch retinal vein occlusion.
ARCALYST (rilonacept) was approved by the FDA in 2008 and subsequently became the company's first market-stage product. Regeneron has built up a small marketing force to promote the product in the US; ARCALYST is manufactured at the company's plant in New York and is distributed through third parties. ARCALYST targets Cryopyrin-Associated Periodic Syndromes (CAPS), a series of diseases caused by genetic mutations including Muckle-Wells Syndrome and Familial Cold Auto-inflammatory Syndrome. The drug is also being tested for the treatment of gout.
The company was founded in New York City in 1988.