Regeneron full year, quarter income up, global Praluent full year sales jump from $11M to $116M

Regeneron’s quarterly income rose 37% from the same period last year, reaching $353 million. Total sales went up for about $130 million quarter to quarter, topping $1.2 billion. 

The full year net income went from $944 million in 2015 to $1.32 billion in 2016.

Furthermore, the company expects to launch two therapies this year. Invoking hard work over the last decades, the president and chief executive officer of Regeneron Leonard S. Schleifer said that the company expects the U.S. approval of dermatitis drug Dupixent in March. “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,” he said.

The company said that 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.

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.

Sanofi and Regeneron have recently been allowed by the US Court to continue marketing, producing and selling Praluent in the US during the time of an appeal the companies made against Amgens patent claims on the drug.

To remind, in January, 2017, the United States District Court for the District of Delaware issued a permanent injunction banning the Regeneron and Sanofi from marketing, selling, or manufacturing Praluent in the United States.

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, Regeneron said.