Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL® in Japan for the Treatment of Hypercholesterolemia
Rhea-AI Summary
Esperion (NASDAQ: ESPR) announced that its partner Otsuka Pharmaceutical has received approval from Japanese regulators to market NEXLETOL for treating hypercholesterolemia and familial hypercholesterolemia in Japan. This approval marks NEXLETOL's entry into the third-largest global market for cardiovascular prevention.
The approval triggers milestone payments to Esperion under their partnership agreement with Otsuka, which includes tiered royalties of 15-30% on net sales in Japan and additional sales milestone payments. NEXLETOL, a non-statin LDL-C lowering therapy, is now approved across the U.S., Europe, and Japan, establishing a strong global presence for Esperion's cholesterol treatment.
Positive
- Regulatory approval secured in Japan, one of the top 3 global markets for cardiovascular prevention
- Eligible for significant milestone payments upon regulatory approval and National Health Insurance Price Listing
- Will receive tiered royalties of 15-30% on net sales in Japan
- Expanded global footprint with approvals now in US, Europe, and Japan
Negative
- None.
News Market Reaction
On the day this news was published, ESPR declined 3.27%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.4% during that session. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $20M from the company's valuation, bringing the market cap to $593M at that time.
Data tracked by StockTitan Argus on the day of publication.
Third Largest Global Market for Cardiovascular Prevention Represents Significant Global Growth Opportunity for NEXLETOL
ANN ARBOR, Mich., Sept. 19, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today 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.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.
Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and follow Esperion on LinkedIn and X.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, including expected cash runway and profitability, and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, and the risks detailed in Esperion’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FAQ
What regulatory approval did Esperion (ESPR) receive in Japan?
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What conditions will NEXLETOL treat in the Japanese market?
In which major markets is NEXLETOL now approved?
What type of medication is NEXLETOL?
