Regeneron (REGN) Tops Q2 EPS by 17c; Updates FY16 Expectations
Regeneron (NASDAQ: REGN) reported Q2 EPS of $2.82, $0.17 better than the analyst estimate of $2.65. Revenue for the quarter came in at $1.21 billion versus the consensus estimate of $1.24 billion.
Marketed Product Update
EYLEA® (aflibercept) Injection for Intravitreal Injection
- In the second quarter of 2016, net sales of EYLEA in the United States increased 27% to $831 million from $655 million in the second quarter of 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 second quarter of 2016, net sales of EYLEA outside of the United States(1) were $486 million, compared to $338 million in the second quarter of 2015. In the second quarter of 2016, Regeneron recognized $167 million from its share of net profit from EYLEA sales outside the United States, compared to $107 million in the second quarter of 2015.
Praluent® (alirocumab) Injection for the Treatment of Elevated Low-Density Lipoprotein (LDL) Cholesterol
- In the second quarter of 2016, global net sales of Praluent were $24 million. 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.
- In the second quarter of 2016, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental Biologics License Application (sBLA) for a monthly dosing regimen of Praluent, with a target action date of January 24, 2017.
- In July 2016, the Japanese Ministry of Health, Labour and Welfare granted marketing and manufacturing authorization for Praluent for the treatment of uncontrolled LDL cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk.
- The ODYSSEY OUTCOMES trial remains ongoing, and is assessing the potential of Praluent to demonstrate cardiovascular benefit.
2016 Financial Guidance(3)
The Company's updated full year 2016 financial guidance consists of the following components:
EYLEA U.S. net product sales | 20% - 25% growth over 2015 (reaffirmed) |
Sanofi reimbursement of Regeneron commercialization-related expenses | $310 million - $340 million (previously $320 million - $370 million) |
Non-GAAP unreimbursed R&D(2) (4) | $970 million - $1.01 billion (previously $875 million - $950 million) |
Non-GAAP SG&A(2) (4) | $980 million - $1.02 billion (previously $925 million - $1.0 billion) |
Effective tax rate | 33% - 41% |
Capital expenditures | $480 million - $530 million (previously $550 million - $625 million) |
For earnings history and earnings-related data on Regeneron (REGN) click here.