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Esperion and Daiichi Sankyo Europe Announce $125 Million Amendment to Their Collaboration, Including Resolution of Pending Litigation

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Esperion Therapeutics, Inc. (NASDAQ: ESPR) and Daiichi Sankyo Europe GmbH (DSE) announced a $125 million amendment to their collaboration, including a $100 million payment to Esperion and expansion of collaboration in Europe and other territories.
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The recent amendment to the collaboration between Esperion Therapeutics and Daiichi Sankyo Europe involving a $125 million adjustment, including a $100 million near-term payment, is a strategic move with significant financial implications. The resolution of the commercial dispute and the transfer of certain manufacturing and supply rights to DSE not only streamline operations but also signal a commitment to cost savings and operational efficiency. This is indicative of a strong partnership that is poised to leverage economies of scale and improve profit margins. The expansion of the collaboration to potentially develop and market a triple formulation product is a forward-looking strategy that could tap into a growing market for comprehensive cholesterol management solutions. The financial injection and strategic realignment have the potential to bolster Esperion's balance sheet and accelerate growth, which may be reflected in the company's stock performance and investor confidence.

The focus on cardiovascular disease, a leading global cause of death and disability, underscores the high demand for effective treatment options like bempedoic acid. The anticipation surrounding the EMA's decision on the Type II(a) variation approval for NILEMDO® and NUSTENDI® suggests that these products have the potential to capture a significant share of the European market, pending regulatory green light. The therapeutic profile of bempedoic acid, particularly when combined with ezetimibe and potentially a statin, positions the collaboration's pipeline as a differentiated player in the cardiovascular pharmaceutical space. The market for cholesterol-lowering drugs is competitive and the success of this collaboration hinges on their ability to differentiate their products and demonstrate superior efficacy or patient outcomes. The potential development of a triple formulation product could address a market gap and offer a unique value proposition, which is crucial for long-term commercial success.

The dismissal of the legal action pending in the United States District Court for the Southern District of New York removes a layer of uncertainty and potential financial risk for both Esperion and Daiichi Sankyo Europe. Legal disputes can often be a drain on resources and their resolution is typically viewed positively by stakeholders. Additionally, DSE taking the lead in regulatory communications with the EMA could streamline the approval process for the pending applications, potentially reducing time to market and associated costs. This strategic legal maneuvering and the resolution of disputes are key in maintaining a smooth path to market for pharmaceutical products, which can ultimately influence the speed at which these treatments generate revenue.

– Near term payment to Esperion of $100 million plus $25 million in calendar quarter following EMA’s expected decision on Type II(a) variation approval of NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet –

– Amendment also includes transfer of certain manufacturing and supply rights to DSE and expansion of collaboration in Europe and other territories –

ANN ARBOR, Mich. and MUNICH, Germany, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ: ESPR) and Daiichi Sankyo Europe GmbH (DSE), the European headquarter organization of the Japanese pharmaceutical company Daiichi Sankyo Co., Ltd. (TSE: 4568), announced today a $125 million amendment to their collaboration, which includes an amicable resolution to their commercial dispute and certain other adjustments to enhance the long-term value of their products.

DSE has agreed to pay Esperion $100 million in mid-January ahead of an anticipated Type II(a) variation approval by the European Medicines Agency (EMA) for NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet. DSE will make an additional $25 million payment to Esperion in the calendar quarter immediately following EMA's decision on the pending application. The legal action pending in the United States District Court for the Southern District of New York will be dismissed.

The parties also agreed, as part of the resolution:

  • for Esperion to transition to DSE manufacturing and supply responsibilities in Europe and other territories, resulting in significant cost savings and efficiencies for both companies.
  • to expand their collaboration in Europe and other territories, to include the potential development and commercialization of a triple formulation product comprising bempedoic acid, ezetimibe and a statin, which could represent significant long-term value for the collaboration.
  • for DSE to now lead all regulatory communications with the EMA regarding the pending applications.

“We are pleased that this settlement creates value for Esperion today through cash payments and includes additional terms that will continue creating value for both companies going forward. Importantly, today’s settlement allows Esperion and DSE to focus on the business at hand – delivering life-saving drug therapies to millions with high cholesterol,” said Sheldon Koenig, Esperion’s President and CEO. “Together, we are committed to making bempedoic acid a blockbuster franchise worldwide, based on the differentiating profiles of our products.”

“This is a positive resolution for patients. We look forward to continuing to apply our combined strengths around the world to bring innovative pharmaceutical products to patients with cardiovascular disease, the greatest cause of death and disability globally,” said Oliver Appelhans, Head of the Specialty Business Unit of Daiichi Sankyo Europe.

Since 2019, Esperion and DSE have worked together to bring bempedoic acid to the eligible patient population and unlock its potential for cardiovascular risk reduction. The partnership continues to grow, with DSE recently gaining approvals for bempedoic acid in the Netherlands, Slovakia, and Spain.

About Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.

About Daiichi Sankyo
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichi-sankyo.eu.                                             

Media Contacts:

For Esperion:

Investors:
Alexis Callahan
investorrelations@esperion.com
(406) 539-1762

Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438

For Daiichi Sankyo Europe:

Investor Relations Contact (Japan):
DaiichiSankyoIR@daiichisankyo.co.jp

Dr. Wolfgang Schiessl (Europe)
wolfgang.schiessl@daiichi-sankyo.eu
+49 151 1714 7317

Sean Wood (Global / US)
swood@webershandwick.com
+1 (212) 445-8310


FAQ

What is the recent collaboration amendment between Esperion Therapeutics and Daiichi Sankyo Europe?

The recent collaboration amendment includes a $125 million payment, with $100 million to be paid to Esperion, and an expansion of collaboration in Europe and other territories.

What is the ticker symbol of Esperion Therapeutics?

The ticker symbol of Esperion Therapeutics is ESPR.

What products are involved in the collaboration between Esperion Therapeutics and Daiichi Sankyo Europe?

The collaboration involves NILEMDO® (bempedoic acid) Tablet and NUSTENDI® (bempedoic acid and ezetimibe) Tablet.

What is the expected payment to Esperion Therapeutics from Daiichi Sankyo Europe?

Esperion Therapeutics is expected to receive a $100 million payment from Daiichi Sankyo Europe, with an additional $25 million in the calendar quarter following the EMA's decision on the pending application.

What is the recent development in the collaboration between Esperion Therapeutics and Daiichi Sankyo Europe?

The recent development includes the transfer of certain manufacturing and supply rights to DSE, expansion of collaboration in Europe and other territories, and the potential development and commercialization of a triple formulation product.

Esperion Therapeutics, Inc.

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