Core Insights - The European Commission has approved label updates for NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid/ezetimibe fixed-dose combination) as treatments to reduce cardiovascular risk by lowering LDL-C levels, making bempedoic acid the first and only LDL-C lowering treatment indicated for both primary and secondary prevention of cardiovascular events [1][2][3] Group 1: Approval and Indications - The approval is based on positive results from the CLEAR Outcomes trial, which involved 13,970 patients across 1,250 sites in 32 countries, including 485 sites in Europe [6][17] - Bempedoic acid and its fixed-dose combination are indicated for adults with established or at high risk for atherosclerotic cardiovascular disease to lower LDL-C levels and reduce cardiovascular risk [2][15] Group 2: Market Need and Impact - Approximately one in seven people in Europe have high LDL-C levels, with cardiovascular disease being the leading cause of death, resulting in over 10,000 deaths daily [3] - Up to 80% of patients do not achieve guideline-recommended LDL-C goals despite treatment with statins, indicating a significant unmet medical need [3][4] Group 3: Efficacy of Treatments - Bempedoic acid can provide an additional cholesterol lowering of up to 28% on top of statin therapy compared to placebo [4] - The bempedoic acid/ezetimibe fixed-dose combination reduced LDL-C by 38% compared to placebo in high-risk patients already on maximum-tolerated statin therapy [4][15] Group 4: Statements from Company Executives - Company representatives expressed confidence that the new indication will help healthcare professionals better meet treatment needs and reassure patients about their cardiovascular risk management [5][6]

ANN ARBOR, Mich., May 20, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) and Otsuka Pharmaceutical Co., Ltd (Otsuka) announced today that the primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid as a potential treatment for patients with hypercholesterolemia. The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan. INDICATION Bempedoic acid, created by Esperion Therapeutics ...

ANN ARBOR, Mich., May 20, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) and Otsuka Pharmaceutical Co., Ltd (Otsuka) announced today that the primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid as a potential treatment for patients with hypercholesterolemia. The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to patients in Japan. Bempedoic acid, created by Esperion Therapeutics, Inc. (Es ...

ANN ARBOR, Mich., May 10, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that on May 8, 2024, the Company granted 16 new employees 62,300 restricted stock units (RSUs) under Esperion's 2017 Inducement Equity Incentive Plan. The 2017 Inducement Equity Incentive Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Esperion (or following a bona fide period of non-employment), as an inducement material to such ind ...

Esperion Therapeutics, Inc. (ESPR) reported earnings of 34 cents per share in the first quarter of 2024, against the Zacks Consensus Estimate of a loss of 8 cents. The company incurred a loss of 79 cents per share in the year-ago quarter.Esperion generated revenues of $137.7 million, up nearly 467% year over year. The upside was driven by the receipt of a milestone payment and increased demand for the company’s drugs across all regions. Per management, this is the highest level of revenues generated by the ...

Financial Data and Key Metrics Changes - The company reported total revenue of $137.7 million for Q1 2024, which includes a $100 million litigation-related settlement, marking a 467% increase year-over-year. Excluding this settlement, total revenue grew by 65% year-over-year [12][32]. - U.S. net revenue reached $24.8 million, reflecting a 46% increase year-over-year, driven by a 43% increase in retail prescription equivalents [13][31]. - Collaboration revenue, which includes combined royalty and partner revenue, was $113 million, an increase of 1,148% year-over-year, largely due to the aforementioned settlement [31]. Business Line Data and Key Metrics Changes - Retail prescription equivalents increased by 43% year-over-year and 6% quarter-over-quarter, indicating strong momentum in the company's ongoing business [28]. - The company has seen a balanced prescribing pattern between primary care physicians and cardiologists, with expectations for increased primary care prescribing as enthusiasm for the new label grows [2][3]. Market Data and Key Metrics Changes - The FDA approved new labels for NEXLETOL and NEXLIZET, expanding the addressable population to over 70 million patients in the U.S. alone, which is significant for both primary and secondary prevention patients [14][16]. - In Europe, approximately 255,000 patients have been treated with the company's therapies, representing a sequential growth of 26% since November [29]. Company Strategy and Development Direction - The company is focused on capitalizing on the new label approvals and has implemented various commercialization initiatives, including a consumer campaign and training for field teams [18][20]. - The strategic plan aims to achieve blockbuster status for its franchise by reaching millions of patients in need of its therapies [38][39]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued growth, emphasizing that the early qualitative feedback from customers is encouraging and that they expect progressive increases in prescribing as payer changes align with the new label [3][21]. - The company anticipates that the majority of utilization management changes will align with the new label over the next two quarters, which is expected to drive further growth [42]. Other Important Information - The company reported a cash and cash equivalents balance of $226.6 million as of March 31, 2024, compared to $82.2 million at the end of 2023, indicating a strong balance sheet [35]. - The company reiterated its 2024 expense guidance, expecting R&D expenses to be between $45 million and $55 million and SG&A expenses to be between $180 million and $190 million [35]. Q&A Session Summary Question: Can you comment on prescription habits from doctors since the label update? - Management noted strong enthusiasm for the new label and balanced prescribing between primary care and cardiologists, with expectations for increased primary care prescribing [2][3]. Question: What is the expected timeline for script growth to reaccelerate? - Management anticipates progressive increases in prescribing as utilization management changes align with the new label, expecting full growth realization in about two quarters [42]. Question: How will utilization management updates look across payers? - Management indicated that updates are expected to be standard across payers, with positive changes already seen from Medicare payers [43][91]. Question: What is the current understanding of statin intolerance? - Management clarified that statin intolerance affects a broader range of patients, with estimates suggesting that the number of patients unable to take or escalate statin doses could be closer to 30% [84][98]. Question: How is the company measuring success in its commercial efforts? - The company is measuring success through discussions with healthcare providers and tracking both commercial and digital reach, with a current sales force of 150 covering about 45,000 healthcare providers [50][60]. Question: What role do patients play in driving treatment decisions? - Management acknowledged that patients are becoming more informed and are actively seeking alternatives to statins, which is influencing treatment guidelines [62][110].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35986 Esperion Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

Financial Performance - Total revenue reached $138 million, a significant increase of 467% year-over-year[5] - US product sales, net, amounted to $25 million, representing a 46% increase year-over-year[5] Prescription Growth - Retail prescription equivalents experienced a 43% year-over-year growth[5] and 6% quarter-over-quarter growth[8] - New to Brand Rx Trends increased by 79%[29] Label Expansion and Market Access - FDA approval of new labels for NEXLETOL and NEXLIZET expands the addressable patient population to over 70 million in the US[8, 13, 19] - The new labels include indications for primary prevention and removal of the statin use qualifier[8, 11] - Utilization management criteria updates by two major payers now cover 40 million lives[9] International Expansion - Medicines Approved in 30+ Countries[33] - International growth continues with 255,000 patients through February '24[37] Financial Position - Q1 2024 cash and cash equivalents totaled $227 million[39] - FY 2024 R&D guidance is $45 - 55 million[40] - FY 2024 SG&A guidance is $180 - 190 million[40] - FY 2024 OpEx guidance is $225 - 245 million, including $20 million of non-cash stock-based compensation expense[40, 41]

Esperion Therapeutics (ESPR) came out with quarterly earnings of $0.34 per share, beating the Zacks Consensus Estimate of a loss of $0.08 per share. This compares to loss of $0.79 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 525%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.53 per share when it actually produced a loss of $0.50, delivering a surprise of 5.66%.Over the last four ...

– Q1 Retail Prescription Equivalents Grew 43% Y/Y and 6% Q/Q, Increased Momentum from Label Expansions Expected Throughout 2024 – – Received U.S. FDA Approval of Broad New Label Expansions for NEXLETOL (bempedoic acid) Tablet and NEXLIZET (bempedoic acid and ezetimibe) Tablet, Becoming the First LDL-C Lowering Non- Statins to Prevent Heart Attacks and Reduce Cardiovascular Risk in Primary and Secondary Prevention Patients – ® ® Exhibit 99.1 Esperion Reports First Quarter 2024 Financial Results – Q1 Total Re ...