Approval Sought in Japan for New Drug to Lower Cholesterol
Research Report

1. Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor.
2.  This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company. 
3. This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for H.C. Wainwright & Co., Esperion Therapeutics Inc., November 26, 2024

This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to unsubscribe@hcwresearch.com and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Joseph Pantginis, Ph.D., Lander Egaña Gorroño, Ph.D., Joshua Korsen, Ph.D., Matthew Keller, Ph.D. and Sara Nik, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Esperion Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of October 31, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Esperion Therapeutics, Inc..

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Esperion Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did receive compensation from Esperion Therapeutics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Esperion Therapeutics, Inc. during the past 12 months. The Firm does not make a market in Esperion Therapeutics, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

A new drug application (NDA) for Esperion Therapeutics Inc.'s (ESPR:NASDAQ) bempedoic acid as a hypercholesterolemia treatment was submitted to Japan's Pharmaceuticals and Medical Devices Agency by Esperion partner Otsuka Pharmaceuticals, reported H.C. Wainwright & Co. Analyst Dr. Joseph Pantginis in a Nov. 26 research note. Otsuka, a private firm, owns the exclusive rights to develop and commercialize this drug in Japan.

"We expect approval in H1/25, backed by favorable Phase 3 data," Pantginis wrote, referring to the CLEAR Outcomes clinical trial.

523% Return Potential

On the news, H.C. Wainwright maintained its US$16 per share price target on Esperion, trading at the time of the report at about US$2.57 per share, noted Pantginis. The target implies a return on investment of 523%.

The Mich., U.S.-based biopharma remains a Buy.

Pursuing Additional Markets

The analyst highlighted that this current effort to get bempedoic acid approved in Japan is part of Esperion's multipronged expansion of the drug franchise into additional international markets.

Other regulatory approvals being sought are for Otsuka to market bempedoic acid under the name Nilemdo in Taiwan, for bempedoic acid as a new drug in Canada (response expected soon), and for possible partnerships on bempedoic acid in Australia and Israel.

"We are glad to learn that Esperion remains focused on a well-established commercial development strategy that validates a strong momentum for bempedoic acid," Pantginis added. "Esperion remains focused on strengthening bempedoic acid's future global growth by engaging with payers, physicians, and healthcare professionals."

CLEAR Outcomes Trial Results

This Phase 3 trial, conducted in Japan, involved 96 patients with high LDL-C levels and either statin intolerance or inadequate response to statins, Pantginis explained. In the study, bempedoic acid met the primary endpoint of lowering cholesterol.

At week 12, in the bempedoic acid group, according to preliminary results, LDL-C was lowered 25.25% versus 3.46% in the placebo group, from baseline. Drug safety and tolerability were consistent with those in previous trials. No serious adverse events were seen.

Added Cardiovascular Benefits

Additional exploratory data from this same study, presented in the Scientific Sessions at the 2024 American Heart Association annual meeting, showed that bempedoic acid (Nexletol and Nexlizet) "builds upon its cardiovascular benefits," Pantginis reported. (Nexletol is bempedoic acid, and Nexlizet is bempedoic acid plus ezetimibe.)

Specifically, the drug reduced major adverse limb events in patients with pre-existing peripheral artery disease by 36% versus placebo. These results suggest that bempedoic acid could be considered for combination therapy, even with statins, in patients with peripheral artery disease.

Also, in the study, bempedoic acid was shown to significantly lower the incidence of major adverse cardiovascular events in patients with liver steatosis or liver fibrosis. This suggests that such cardiovascular management should be started early in patients with metabolic dysfunction-associated steatotic liver disease.

"We believe these results add to the current LDL-C lowering and cardiovascular risk reduction labels and should be seen as valuable clinical outcomes that could potentially support the adoption of bempedoic acid by the physician community," wrote Pantginis.

Data Out of Germany

Pantginis also reported that long-term follow-up data from the MILOS trial in Germany "supports adoption of Nilemdo (bempedoic acid) and Nustendi (bempedoic acid plus) in Europe. These showed that after one to two years of treatment, LDL-C cholesterol in the overall population (451 patients) was lowered 30.3% on average.

After two years, the percentage of patients who met their LDL-C goals increased sevenfold to 35.3% from 4.9% at baseline. Similar trends were noted among high-risk patients, 32.5% versus 5.6%, and very high-risk patients, 35.2% versus 3.6%.

New Deal To Boost Revenue

In other news, according to Pantginis, Esperion entered into a new royalty purchase agreement with OMERS Life Sciences, a private company, in which OMERS will pay Esperion US$304.7 million in cash for 100% interest in Esperion's royalty entitlement on Daiichi Sankyo Europe's net sales of Nilemdo and Nustendi in Europe.

Under this deal, Pantginis noted, sales of these drugs should generate long-term revenue for Esperion. So far, it has used these revenues to pay off its facility with Oberland Capital.

"This new deal allows Esperion to fully focus on the commercialization efforts for Nexletol and Nexlizet in the U.S.," Pantginis wrote.

Commercialization of these two drugs is in progress in the States. Coverage of them by commercial insurers and Medicare increased to greater than 92% and greater than 65%, respectively. This suggests physician confidence in Nexletol and Nexlizet and predicts strong sales in the near term and beyond.

"Updated utilization management criteria for more than 165 million lives aligned to the new labels across commercial, Medicare and Medicaid payers," wrote Pantginis.