ANN ARBOR, Mich., April 29, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the company will be participating in the following webcasted investor events during the month of May, which can be found on our investor relations website. JMP Securities’ Life Sciences Conference in New York on May 13, 2024, at 2:30 p.m. ET. Bank of America Securities’ 2024 Health Care Conference in Las Vegas on May 15, 2024, at 3:00 p.m. PT / 6:00 p.m. ET. H.C. Wainwright’s 2nd Annual BioConnect Investor Conf ...

– Patients With Obesity Who Took NEXLETOL Were 23% Less Likely to Experience a Major Adverse Cardiovascular Event (MACE-4) Compared to Placebo – – NEXLETOL Demonstrated Clinical Benefit in Historically Underrepresented Groups: Women and Hispanic/Latinx Patients With and Without Cardiovascular Disease (CVD) – – CLEAR Outcomes Sets New Standards for Diversity and Inclusion with Enrollment of 48% Women and 17% Hispanic/Latinx Patients – ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR ...

– New Labels Expand Treatable Population to ~70 Million Patients in U.S. – – First LDL-C Lowering Non-Statin Indicated for Primary Prevention Patients – – Approvals Based on Positive CLEAR Outcomes Data and Reflect a Highly Differentiated Product Profile – – Positive CHMP Opinion Received; European Cardiovascular (CV) Risk Reduction Label Determination Anticipated in Q2 2024 – – Conference Call and Webcast on Monday, March 25 at 8:00 a.m. ET – ANN ARBOR, Mich., March 22, 2024 (GLOBE NEWSWIRE) -- Esperion (N ...

– Positive CHMP Opinions Are Based On The Analyses Of The Phase 3 Of The CLEAR (Cholesterol Lowering via Bempedoic Acid, an ATP Citrate Lyase (ACL)-Inhibiting Regimen) Outcomes Trial1 – – European Commission Decision On Label Update Authorization Applications Are Expected To Be Made In 1H 2024 – ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo') and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medic ...

skynesher/E+ via Getty Images After Esperion Therapeutics (NASDAQ:ESPR) rolled out a secondary offering in mid-January, the initial selling looked set to undermine an otherwise promising biotech story. Fortunately, ESPR never looked back from its gap down open and in turn the stock set up a fresh buying opportunity. Roll the calendar forward to the company’s recent earnings report, and I can release my next sigh of relief. The post-earnings gain of 10.3% was not enough for a breakout, but momentum at le ...

Esperion Therapeutics, Inc. (ESPR) incurred a loss per share of 50 cents in the fourth quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of 53 cents. The company incurred a loss of 76 cents per share in the year-ago quarter.Esperion generated revenues of $32.3 million, up 72% year over year. The reported figure beat the Zacks Consensus Estimate of $26.8 million.Quarter in DetailEsperion has two FDA-approved drugs in its commercial portfolio — Nexletol and Nexlizet — that are approved for ...

Esperion Therapeutics (ESPR) came out with a quarterly loss of $0.50 per share versus the Zacks Consensus Estimate of a loss of $0.53. This compares to loss of $0.76 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 5.66%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.42 per share when it actually produced a loss of $0.37, delivering a surprise of 11.90%.Over the last four quarters, t ...

Financial Performance - In 2023, the company generated $78.3 million in net revenues from the sale of its products in the U.S.[204] - The company has generated $187.2 million in net revenue from product sales in the U.S. since the launch of its products[306] - The net losses for the years ended December 31, 2023, and 2022 were $209.2 million and $233.7 million, respectively, with an accumulated deficit of $1.5 billion as of December 31, 2023[307] - The company expects to incur significant expenses and operating losses for the foreseeable future related to the commercialization of NEXLETOL and NEXLIZET[308] - The company anticipates an increase in selling, general, and administrative expenses in 2024 due to potential additional global regulatory approvals and expanded commercialization initiatives[308] - The company has incurred significant operating losses since its inception and anticipates continued losses for the foreseeable future[306] Regulatory Approvals and Challenges - The FDA approved NEXLETOL (bempedoic acid) and NEXLIZET (bempedoic acid and ezetimibe) in February 2020, with commercial availability starting in March and June 2020 respectively[204] - The company expects approval decisions on expanded indications for NEXLETOL and NEXLIZET in the first quarter of 2024[205] - The company faces risks related to obtaining regulatory approvals for its products in various territories[206] - The company acknowledges that any setbacks in regulatory approvals could materially affect its business and prospects[211] - Regulatory authorities may impose significant restrictions on bempedoic acid and the bempedoic acid/ezetimibe combination tablet's indicated uses or marketing, requiring costly post-approval studies[217] - The FDA has mandated both a PK/PD and Phase 3 study for bempedoic acid in patients with HeFH aged 10 to less than 18 years as part of the approval process[217] Market Competition - The market for LDL-C and cardiovascular risk-lowering therapies is highly competitive, with significant competition from generic statins and other pharmaceutical companies[260] - The company faces potential competition from generic versions of bempedoic acid and the bempedoic acid/ezetimibe combination tablet, which could adversely affect sales[220] - The company faces competition from inexpensive generic versions of statins and other lipid-lowering therapies, which could impact market share[263] - Competitors may have greater financial and technical resources, potentially impacting the company's ability to achieve regulatory approval and market acceptance for its products[262] - The company has received marketing approval for bempedoic acid and the bempedoic acid/ezetimibe combination tablet in the U.S. and Europe, but may face challenges in achieving broad market acceptance, which could limit revenue generation[265] Financial and Capital Needs - The company may need to pursue equity or debt financings to meet its capital needs due to market volatility[199] - The company may need substantial additional capital in the future to fund ongoing operations and commercialization efforts[311] - The company may face challenges in generating sufficient cash flow to service its debt obligations, which could lead to asset sales or restructuring[322] - Payment requirements under the RIPA may increase cash outflows significantly starting in 2025 if certain revenue milestones are not met, potentially leading to higher payments[318] - The company has issued $280.0 million of 4.00% convertible senior subordinated notes due 2025, with interest payable semi-annually[322] Compliance and Legal Risks - Relationships with healthcare providers and third-party payors are subject to strict healthcare laws, which could expose the company to legal and financial risks[224] - The company may face damages, fines, or penalties if it fails to comply with relevant laws and regulations regarding patient assistance programs[228] - The company may incur significant legal expenses and operational disruptions due to investigations or actions stemming from non-compliance with healthcare laws[229] - The company faces significant civil monetary penalties if found to have submitted false pricing information to CMS or failed to submit required price data on time[245] - The company is subject to risks related to intellectual property litigation, which could result in substantial damages and affect product commercialization[300] Intellectual Property and Patents - As of December 31, 2023, the company holds approximately 10 issued U.S. patents and 17 pending U.S. patent applications, along with over 25 issued patents and over 80 pending applications in foreign jurisdictions[342] - U.S. Patent No. 7,335,799, covering bempedoic acid, is set to expire in December 2025, with a potential five-year extension requested[343] - The company is pursuing patent protection for the bempedoic acid/ezetimibe combination tablet, with claims in U.S. Patent Nos. 10,912,751 and 11,744,816 scheduled to expire in March 2036[344] - The company faces risks from potential competitors filing for generic versions of bempedoic acid or the combination tablet, which could adversely affect future revenue and profitability[353] - The company relies on unpatented trade secrets and technological innovation, protected by confidentiality agreements with employees and collaborators[356] Operational Risks - The company relies entirely on third-party suppliers for the manufacturing of clinical drug supplies for bempedoic acid and the bempedoic acid/ezetimibe combination tablet, lacking internal manufacturing capabilities[376] - Any delays in finding alternative contract research organizations (CROs) could significantly impact the commercialization timeline of bempedoic acid products, potentially incurring substantial costs[375] - The company must maintain a risk management plan under the CARES Act to address potential shortages in the supply of approved drugs, which could materially impact results[378] - The company is exposed to risks related to employee misconduct, which could lead to regulatory sanctions and harm its reputation[274] Market and Stock Performance - The stock price of the company is subject to volatility influenced by various factors, including clinical trial results and regulatory actions[381] - The company qualifies as a "smaller reporting company," allowing for reduced public disclosure, which may affect the attractiveness of its common stock to investors[387] - If analysts cease coverage or publish unfavorable reports, the company's stock price and trading volume could decline[389] Environmental, Social, and Governance (ESG) Considerations - Increased scrutiny regarding environmental, social, and governance (ESG) initiatives may lead to higher costs and reputational risks for the company[390] - The company may engage in voluntary ESG initiatives, but these could be costly and may not yield the desired outcomes[391]

Esperion Therapeutics (ESPR) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended December 2023. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they mi ...

ANN ARBOR, Mich., Feb. 13, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR), today announced it will report fourth quarter and full year 2023 financial results before the market opens on Tuesday, February 27, 2024. Following the release, management will host a webcast at 8:00 a.m. ET to discuss these financial results and provide business updates. Please click here to pre-register to participate in the conference call and obtain your dial in number and PIN. Already registered? Access with your PIN here.  A ...