Esperion announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka), the Company’s partner for the development and commercialization of NEXLETOL^® (bempedoic acid) tablets in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL as a treatment for hypercholesterolemia and familial hypercholesterolemia.

“Securing regulatory approval in Japan – one of the top three global markets for cardiovascular prevention – represents a major step forward in our international growth strategy. With NEXLETOL now approved across the U.S., Europe, and Japan, we’ve established a strong global footprint and expanded access to a differentiated, non-statin LDL-C lowering therapy for patients who need alternatives,” said Sheldon Koenig, President and CEO of Esperion. “Our partnership with Otsuka positions us to unlock significant value in Japan, and we remain focused on driving long-term growth and shareholder value through continued innovation and market expansion.”

Under the terms of the collaboration and license agreement, Esperion is eligible to receive significant milestone payments upon regulatory approval and National Health Insurance Price Listing for NEXLETOL in the Otsuka territory. In addition, Esperion is eligible to receive additional sales milestone payments based on total net sales achievements by Otsuka in Japan, as well as tiered royalties ranging from fifteen percent to thirty percent on net sales in Japan.