- Veteran Industry Executive Brings Decades of Financial and Leadership Experience - ANN ARBOR, Mich., April 01, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced the appointment of Robert E. Hoffman as an independent director, effective immediately, and he will also serve as Chairperson of the Audit Committee effective May 29, 2025. In addition, the Company announced that Nicole Vitullo and Antonio M. Gotto, Jr., M.D., D. Phil. will step down from the board of directors, effective June 1, 20 ...

ANN ARBOR, Mich., March 24, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that the company will be participating in the webcasted 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 8:45 a.m. ET. The live webcast can be accessed on the investor and media section of the Esperion website. Access to the webcast replay will be available approximately two hours after the completion of the call and will be archived on the Company’s website for approximately 90 days. Esperion ...

Esperion Therapeutics (ESPR) announced that it has come to an alignment with the FDA for initiating two phase III studies. The studies will evaluate bempedoic acid alone and in combination with ezetimibe in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). The phase III studies are expected to begin later in 2025.Esperion markets bempedoic acid as Nexletol and Nexlizet for treating elevated LDL-C (bad cholesterol) and cardiovascula ...

– Confirms Sufficient Data to Complete Phase 2 Clinical Study Enrollment and Advance to Phase 3 Studies in Both Heterozygous and Homozygous Familial Hypercholesterolemia – – Establishes Pediatric Path Forward to Start and Complete Phase 3 Trial and Secure Additional Six-Month Patent Extension Through June 2031 – ANN ARBOR, Mich., March 20, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that following meetings with the U.S. Food and Drug Administration (FDA), it has gained alignment on a re ...

Financial Performance - In 2024, the company generated $115.7 million in net revenues from the sale of products in the U.S.[217] - The company has generated $302.9 million in net revenue from product sales in the U.S. since the launch of its products[341]. - The company incurred net losses of $51.7 million, $209.2 million, and $233.7 million for the years ended December 31, 2024, 2023, and 2022, respectively[342]. - As of December 31, 2024, the company had an accumulated deficit of $1.6 billion[342]. - The company anticipates continued operating losses for the near term future related to commercialization and research and development expenses[343]. - The company may need to secure additional cash resources or reduce spending to continue its operations effectively[342]. - The company may require substantial additional capital in the future to continue operations if current resources are insufficient[345]. Regulatory Approvals and Challenges - The FDA approved new label expansions for NEXLETOL and NEXLIZET on March 22, 2024, including indications for cardiovascular risk reduction and expanded LDL-C lowering[217]. - The company has received regulatory approvals from the FDA, EMA, UK MHRA, and Swissmedic for both leading product candidates[220]. - The company has received marketing approval for bempedoic acid and the bempedoic acid/ezetimibe combination tablet in the U.S., Europe, and parts of Asia, but may face ongoing regulatory challenges and restrictions[232]. - The company may face regulatory delays or rejections due to changes in regulatory policy during product development, impacting its financial prospects[319]. - The company is subject to ongoing regulatory oversight, which could lead to adverse publicity, penalties, or the suspension of marketing approvals if compliance issues arise[233]. Market Competition - The market for LDL-C and cardiovascular risk lowering therapies is highly competitive, with significant competition from inexpensive generic versions of statins and other therapies[288]. - Competitors may file ANDAs for generic versions of bempedoic acid and the combination tablet, potentially leading to significant sales losses for the company[238]. - The company expects to encounter intense competition as new drugs enter the market and advanced technologies become available[291]. Intellectual Property and Legal Risks - The company has initiated patent infringement lawsuits against ANDA filers to protect its NEXLETOL and NEXLIZET products, with trials anticipated to begin no earlier than January 2027[243]. - The company may face significant costs and management distraction from potential litigation regarding intellectual property rights[335]. - The company may encounter significant challenges in enforcing its intellectual property rights in foreign jurisdictions, which could hinder its competitive position[404]. - The company has received notices from nine pharmaceutical companies regarding ANDA filings for generic versions of NEXLETOL and NEXLIZET, which could adversely affect future revenue and profitability[395]. Compliance and Regulatory Environment - The company must navigate complex healthcare laws and regulations that could expose it to criminal sanctions and civil penalties related to its relationships with healthcare providers[246]. - Compliance failures with healthcare laws can result in civil, criminal, and administrative penalties, including exclusion from federal healthcare programs[251]. - The U.S. government has increased scrutiny on pharmaceutical companies' patient assistance programs, leading to significant civil and criminal settlements[248]. - The company is subject to regulatory actions and claims related to data privacy laws, which could result in significant liabilities[309]. Collaboration and Partnerships - The company has entered into multiple collaboration agreements for the commercialization of bempedoic acid and the bempedoic acid/ezetimibe combination tablet in various territories, including agreements with DSE, Otsuka, and DS[406][407]. - The collaboration with DSE includes tiered royalties ranging from 15% to 25% on certain net sales in the DSE Territory, while the agreement with Otsuka includes tiered royalties from 15% to 30% on net sales in Japan[408]. - The potential revenue from collaborations may be impacted by the partners' ability to effectively market and sell the products, as well as the company's ability to obtain necessary regulatory approvals[408][410]. Operational Risks - The company relies on sole source third-party suppliers for the manufacturing of bempedoic acid and the combination tablet, which poses risks to meeting commercial demand[231]. - The company is exposed to risks from cybersecurity incidents that could disrupt the commercialization and development programs for its products[306]. - The company relies on third parties for manufacturing and conducting clinical trials, which poses risks if those third parties experience cybersecurity issues[307]. - The company may face delays or hurdles related to ongoing commercial launches that could affect revenue expectations[217]. Financial Obligations and Capital Structure - The company has a $150.0 million term loan under a Credit Agreement, which was fully borrowed at closing to repay part of its existing obligations[351]. - The company must maintain minimum liquidity of $50.0 million as per the Credit Agreement, which includes various affirmative and negative covenants[354]. - The conditional conversion feature of the Notes may adversely affect the company's financial condition and liquidity if triggered, requiring cash payments for conversion obligations[366]. Research and Development - Research and development expenses are expected to increase slightly in 2025 due to the start of a pediatric phase III trial and ongoing preclinical pipeline work[343]. - The company completed the CLEAR Outcomes CVOT in December 2022, with plans for additional clinical studies of bempedoic acid and the bempedoic acid/ezetimibe combination tablet[316]. Data Privacy and Cybersecurity - Compliance with the EU General Data Protection Regulation (GDPR) may require significant investment and could lead to fines of up to €20 million or 4% of annual global revenues for violations[271]. - The California Consumer Privacy Act (CCPA) and its amendments under the CPRA impose stringent privacy obligations, potentially increasing compliance costs and risks of litigation[276]. - The company is subject to scrutiny regarding personal data transfers to foreign countries, particularly under the Biden Administration's executive order restricting certain transactions[280].

Core Insights - Esperion Therapeutics reported a narrower loss of 10 cents per share for Q4 2024, compared to a loss of 50 cents per share in the same quarter last year, and better than the Zacks Consensus Estimate of a loss of 14 cents [1][10] - The company generated revenues of $69.1 million in Q4 2024, a 114% increase year over year, although it fell short of the Zacks Consensus Estimate of $70 million [2][4] - Esperion's stock has declined by 28.1% over the past year, while the industry has seen an 11% decline [2] Financial Performance - Product revenues from the U.S. reached $31.6 million in Q4 2024, up nearly 52% year over year, driven by retail prescription growth [4] - Collaboration revenues surged 227% year over year to $37.6 million, exceeding the Zacks Consensus Estimate of $37.3 million [5][8] - For the full year 2024, Esperion reported revenues of $332.3 million, compared to $116.3 million in the previous year, with a loss of 28 cents per share, an improvement from a loss of $2.03 in the prior year [10] Product Portfolio and Development - Esperion has two FDA-approved drugs, Nexletol and Nexlizet, for treating elevated LDL-C and cardiovascular risk, marketed as Nilemdo and Nustendi in ex-U.S. markets [3] - The company is developing two triple combination products with Nexletol/Nexlizet, which may offer LDL-C lowering of more than 60% [12][13] - Esperion filed new drug submissions in Canada for Nexletol and Nexlizet, with potential approval expected in Q4 2025 [14] Strategic Partnerships - Esperion has partnered with CSL Seqirus to commercialize Nexletol and Nexlizet in Australia and New Zealand, receiving an upfront payment and eligibility for near-term milestones [15] Expense Management - Research and development expenses decreased by 38% year over year to $11 million, primarily due to the close-out of the CLEAR Outcomes study [8] - Selling, general, and administrative expenses were down 19% year over year to $36.9 million [8] Future Guidance - For 2025, Esperion expects operating expenses to be in the range of $215-$235 million, including $15 million in non-cash expenses related to stock compensation [11]

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $69.1 million, an increase of 114% compared to $32.3 million in Q4 2023 [28] - U.S. net product revenue was $31.6 million, up approximately 52% from $20.8 million in the same period last year [28] - Collaboration revenue increased approximately 227% to $37.6 million compared to $11.5 million in Q4 2023 [29] - Research and development expenses decreased by 38% to $11 million from $17.7 million in Q4 2023 [30] - Selling, general and administrative expenses decreased by 19% to $36.9 million from $45.4 million in Q4 2023 [30] - Cash and cash equivalents stood at $144.8 million as of December 31, 2024 [31] Business Line Data and Key Metrics Changes - The company achieved 12% sequential quarterly growth in total retail prescription equivalents (TRPEs) in Q4 2024 compared to Q3 2024 [10] - The prescriber base increased by 10% from the previous quarter, reaching over 25,000 healthcare providers [10] - Royalty revenue from DSE increased 9% sequentially to $9.7 million in Q4 2024, with a full-year increase of 116% year-over-year to $32.6 million [15] Market Data and Key Metrics Changes - The company expanded payer access to over 173 million lives covered in the U.S. [10] - Approximately 453,000 patients have been treated with the company's therapies in Europe, representing 19% sequential growth over the past three months [16] Company Strategy and Development Direction - The company focuses on three strategic pillars: continued revenue growth, operating profitability, and portfolio expansion and pipeline advancement [9] - Plans to introduce triple combination products in the U.S. to address statin intolerance and enhance cardiovascular prevention [12] - The company is actively exploring new therapeutic opportunities and developing next-generation inhibitors for serious diseases [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth and operational flexibility due to a strengthened financial structure [8] - Anticipated improvements in Medicare coverage are expected to normalize revenue growth in 2025 [94] - The company is optimistic about the impact of new product approvals and market expansions in key geographies [14][19] Other Important Information - The company entered into a licensing agreement with Neopharm Israel for exclusive rights to commercialize NEXLETOL and NEXLIZET in Israel [19] - A partnership with CSL Seqirus was established to commercialize NEXLETOL and NEXLIZET in Australia and New Zealand [17] Q&A Session Summary Question: What is the regulatory path for the triple combo in the U.S.? - Management indicated that no additional details would be provided at this time, but it does not necessitate a cardiovascular outcomes trial [42] Question: Can U.S. bempedoic acid revenue in 2025 see accelerated growth? - Management expects a more consistent translation of TRPE growth to revenue growth due to improved access and the smoothing out of gross to net pressures [46] Question: How are efforts to build efficiencies into COGS progressing? - COGS have remained consistent, with ongoing evaluations to drive costs down through validation of cheaper suppliers [50] Question: What feedback is being received from prescribers? - Positive feedback is noted regarding the efficacy of the products, with ongoing education efforts to improve coverage awareness [55] Question: What is the level of maturity regarding potential in-licensing discussions? - The company is conducting a landscape analysis for potential in-licensing opportunities, focusing on products that are late-stage or already approved [60] Question: How does the company view the opportunity to help sell someone else's product? - Management sees this as a significant opportunity given the lack of cardiovascular sales forces in the market [66] Question: What are the expectations for the triple combination products? - The company views the triple combination as complementary to its existing portfolio and anticipates significant LDL lowering benefits [75] Question: How familiar are prescribers with bempedoic acid? - Awareness among healthcare providers is improving, with high aided awareness reported [86] Question: Will the company consider increasing its sales force? - Currently, the sales force is deemed appropriately sized, but evaluations for potential changes are ongoing [89] Question: What is the expected impact of Medicare contracts into 2025? - Management does not expect lingering impacts from Medicare contracts, anticipating a more normalized gross to net rate [94]

Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q4 2024 Earnings Conference Call March 4, 2025 8:00 AM ET Company Participants Alina Venezia - Director of Investor Relations Sheldon Koenig - President and Chief Executive Officer Ben Halladay - Chief Financial Officer Eric Warren - Chief Commercial Officer Conference Call Participants Dennis Ding - Jefferies Joseph Pantginis - H.C. Wainwright Thomas Shrader - BTIG Tanmay Patwardhan - JPMorgan Jason Zemansky - Bank of America Serge Belanger - Needham Paul Choi - Go ...

Core Viewpoint - Esperion Therapeutics reported a quarterly loss of $0.10 per share, which was better than the Zacks Consensus Estimate of a loss of $0.14, marking an earnings surprise of 28.57% [1] - The company’s revenue for the quarter was $69.11 million, missing the consensus estimate by 1.28%, but showing significant growth from $32.25 million a year ago [2] Financial Performance - Over the last four quarters, Esperion has surpassed consensus EPS estimates three times [2] - The company has also topped consensus revenue estimates two times during the same period [2] - The current consensus EPS estimate for the upcoming quarter is -$0.17 on revenues of $63.09 million, and for the current fiscal year, it is -$0.13 on revenues of $310.03 million [7] Stock Performance - Esperion shares have declined approximately 28.2% since the beginning of the year, contrasting with the S&P 500's decline of -0.5% [3] - The stock currently holds a Zacks Rank of 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Industry Outlook - The Medical - Drugs industry, to which Esperion belongs, is currently ranked in the bottom 46% of over 250 Zacks industries, suggesting potential challenges ahead [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Esperion's stock performance [5]

Q4 and Full Year 2024 Earnings Presentation March 4, 2025 © 2025 Esperion Therapeutics, Inc. All rights reserved. Forward-looking Statements & Disclosures This investor presentation 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, future operations, commercial products, clinical development, plans for potential future ...