TARRYTOWN, N.Y., Feb. 9, 2017 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2016 and provided a business update.
Financial Highlights | ||||||||||||||||||||||
($ in millions, except per share data) | Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||||||||
2016 | 2015* | % Change | 2016 | 2015* | % Change | |||||||||||||||||
EYLEA U.S. net product sales | $ | 858 | $ | 746 | 15 | % | $ | 3,323 | $ | 2,676 | 24 | % | ||||||||||
Total revenues | $ | 1,227 | $ | 1,098 | 12 | % | $ | 4,860 | $ | 4,104 | 18 | % | ||||||||||
GAAP net income | $ | 253 | $ | 155 | 63 | % | $ | 896 | $ | 636 | 41 | % | ||||||||||
GAAP net income per share - diluted | $ | 2.19 | $ | 1.34 | 63 | % | $ | 7.70 | $ | 5.52 | 39 | % | ||||||||||
Non-GAAP net income(2) | $ | 353 | $ | 258 | 37 | % | $ | 1,319 | $ | 944 | 40 | % | ||||||||||
Non-GAAP net income per share - | $ | 3.04 | $ | 2.23 | 36 | % | $ | 11.32 | $ | 8.12 | 39 | % | ||||||||||
* See Table 3 of this press release for an explanation of revisions made to 2015 non-GAAP amounts previously reported. | ||||||||||||||||||||||
“The hard work of our scientists over the last decades has brought Regeneron to the next phase of our evolution - this year we anticipate launching two additional important therapies, significantly expanding our impact for patients with serious diseases and our company’s growth potential,” said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. “In March, we look forward to the potential U.S. approval of Dupixent, our innovative and breakthrough IL4/13 blocking antibody, in adults with atopic dermatitis. We believe Dupixent may have the potential to help additional patients with serious allergic diseases, with pivotal Phase 3 data in adult asthma patients expected later this year. We are also studying Dupixent in patients with nasal polyps and pediatric patients with asthma or atopic dermatitis.”
Business Highlights
Marketed Product Update
EYLEA® (aflibercept) Injection for Intravitreal Injection
- In the fourth quarter of 2016, net sales of EYLEA in the United States increased 15% to $858 million from $746 million in the fourth quarter of 2015. For the full year of 2016, net sales of EYLEA in the United States increased 24% to $3.323 billion from $2.676 billion for the full year 2015. Overall distributor inventory levels remained within the Company’s one- to two-week targeted range.
- Bayer commercializes EYLEA outside the United States. In the fourth quarter of 2016, net sales of EYLEA outside of the United States(1) were $496 million, compared to $413 million in the fourth quarter of 2015. In the fourth quarter of 2016, Regeneron recognized $165 million from its share of net profit from EYLEA sales outside the United States, compared to $140 million in the fourth quarter of 2015. For the full year of 2016, net sales of EYLEA outside of the United States(1) were $1.872 billion, compared to $1.413 billion for the full year 2015. For the full year of 2016, Regeneron recognized $649 million from its share of net profit from EYLEA sales outside the United States, compared to $467 million for the full year 2015.
Praluent® (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol
- In the fourth quarter of 2016, global net sales of Praluent were $41 million, compared to $7 million in the fourth quarter of 2015. For the full year of 2016, global net sales of Praluent were $116 million, compared to $11 million for the full year 2015. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent. Praluent was launched in the United States in the third quarter of 2015 and in certain countries in the European Union commencing in the fourth quarter of 2015.
- On January 5, 2017, the United States District Court for the District of Delaware issued a permanent injunction prohibiting the Company and Sanofi from marketing, selling, or manufacturing Praluent in the United States. On February 8, 2017, the United States Court of Appeals for the Federal Circuit stayed (suspended) the injunction pending appeal. This ruling means that Regeneron and Sanofi will continue marketing, selling, and manufacturing Praluent in the United States during the appeal process.
- In the fourth quarter of 2016, the European Commission approved a Praluent dosing regimen of 300mg every 4 weeks. In January 2017, the U.S. Food and Drug Administration (FDA) extended the review period for the supplemental Biologics License Application (sBLA) for a monthly dosing regimen of Praluent. The FDA determined that Regeneron’s and Sanofi’s responses to information requested by the FDA during its review of the sBLA was a major amendment, which results in a three month extension of the Prescription Drug User Fee Act (PDUFA) date to allow time for the FDA to review the additional information. The new target action date is April 24, 2017.
- The ODYSSEY OUTCOMES trial remains ongoing, and is assessing the potential of Praluent to demonstrate cardiovascular benefit. In November 2016, an independent Data Monitoring Committee (DMC) completed a second pre-specified interim analysis. Based on the results of this analysis, the DMC recommended the trial continue as planned. The DMC will continue to monitor the ongoing safety and efficacy of Praluent in the trial.
Pipeline Progress
Regeneron has sixteen product candidates in clinical development. These consist of EYLEA and fifteen fully human monoclonal antibody product candidates generated using the Company’s VelocImmune® technology, including six in collaboration with Sanofi. In addition to EYLEA and Praluent, highlights from the antibody pipeline include:
Sarilumab, the Company’s antibody targeting IL-6R for rheumatoid arthritis.
- In January 2017, Health Canada approved KevzaraTM (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs). This is the first approval of Kevzara worldwide.
- In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for sarilumab. In addition, in October 2016, an application for marketing approval for sarilumab was submitted in Japan.
On October 28, 2016, the Company and Sanofi announced that the FDA issued a Complete Response Letter (CRL) regarding the BLA for sarilumab.
To read full press release, please click here.
