NEXLETOL® (bempedoic acid)
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Esperion Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-11 23:00
Core Insights - Esperion reported preliminary full-year 2025 U.S. net product sales of $156 to $160 million, reflecting a 35% to 38% increase compared to 2024 [1] - The company anticipates total preliminary revenue of $400 to $408 million for 2025, marking a 20% to 23% increase from the previous year, and a 55% to 59% increase when excluding one-time milestones [1] - Esperion introduced its Vision 2040 growth strategy, aiming to evolve into a multi-product, sustainable, innovation-driven global pharmaceutical company [2][4] Financial Performance - Cash and cash equivalents at year-end 2025 are approximately $168 million [1] - Q4 retail prescription equivalents grew by 34% year-over-year and 11.3% quarter-over-quarter [1] - The company expects operating expenses for full-year 2026 to be between $210 million and $245 million [1][14] Vision 2040 Strategy - Vision 2040 aims to establish Esperion as a leader in cardiometabolic indications and expand its pipeline into rare hepatic and renal diseases [4][6] - The strategy includes plans to develop at least five marketed products and a robust pipeline addressing unmet medical needs [4] - Esperion intends to leverage its commercial infrastructure for partnerships, acquisitions, and co-promotion opportunities [5] U.S. Commercial Strategy - NEXLETOL® and NEXLIZET® are FDA-approved for cardiovascular disease prevention, targeting over 70 million patients in the U.S. [7] - The company is focusing on the statin intolerant or resistant market, which constitutes approximately 30% of the overall market [8] - Esperion has strengthened access and reimbursement support for its products, achieving over 90% coverage among commercial lives and Medicare beneficiaries [11] Global Expansion - Esperion has made significant progress in expanding its bempedoic acid products internationally, treating over 600,000 patients across 30 EU countries [12] - The company secured regulatory approval for NILEMDO in France and is advancing oral triple combination lipid-lowering tablets [12] R&D Pipeline - Esperion is advancing its ACLY-focused pipeline, targeting multiple life-threatening diseases with next-generation inhibitors [13][17] - The company nominated ESP-2001 for preclinical development, which addresses primary sclerosing cholangitis and represents a potential market opportunity exceeding $1 billion annually [17] Financial Flexibility - Esperion completed a $75 million capital raise in 2025 to support commercial expansion and pipeline development [14]
Esperion Reaches Settlement Agreement with ANDA Filer, Dr. Reddy’s Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Prior to April 19, 2040
Globenewswire· 2025-10-03 12:00
Core Insights - Esperion has entered into a settlement agreement with Dr. Reddy's Laboratories, resolving patent litigation related to generic versions of NEXLETOL and NEXLIZET, preventing Dr. Reddy's from marketing these generics in the U.S. before April 19, 2040 [1] - The settlement with Dr. Reddy's follows previous agreements with other companies regarding their generic versions of NEXLETOL, ensuring no remaining challenges to the validity of U.S. Patent No. 7,335,799, which expires in December 2030 [2] - Ongoing patent litigation against other defendants remains, with uncertainty regarding the potential for generic versions of NEXLETOL and/or NEXLIZET to be marketed before the 2040 date [3] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medications for patients at risk for cardiovascular disease, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [4] - The company is advancing its pre-clinical pipeline and aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [5]
Esperion(ESPR) - 2025 Q2 - Earnings Call Presentation
2025-08-05 12:00
Financial Performance - Total revenue reached $82.4 million, a 12% increase[7,40] - U S net product sales increased by 42% to $40.3 million[7,40] - Collaboration revenue was $42.1 million, a 7% decrease, but adjusting for a one-time settlement agreement milestone with DSE received in Q2 2024, it represents a 105% increase[40] - The company achieved its first quarter of operating income from ongoing business and anticipates sustainable profitability beginning in Q1 2026[4,40] - Cash and cash equivalents stand at $86.1 million[43] Marketing and Sales - Over 28,000 healthcare providers are now writing prescriptions for the company's products[9,20] - Retail prescription equivalents increased by 10% compared to Q1 2025[7,20,48] - The consumer statin intolerance website received over 650,000 visits in Q2, and the HCP statin intolerance site had over 600,000 click-throughs[15] - A balanced direct and digital marketing approach resulted in 23% of prescriptions written by physicians with only digital touchpoints and 38% of new writer prescriptions driven by digital-only touchpoints[17,20] Pipeline and Strategic Initiatives - The company is advancing IND-enabling studies for a new program in primary sclerosing cholangitis (PSC), representing an approximately $1 billion annual market opportunity, with potential first-in-human studies in 2H 2026[25,36] - Settlements were reached with three ANDA filers to protect NEXLETOL's IP until 2040[25]
Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-07-08 12:00
Core Insights - Esperion has entered into a settlement agreement with Accord Healthcare Inc. to resolve patent litigation regarding the generic version of NEXLETOL, preventing Accord from marketing it in the U.S. before April 19, 2040, under certain conditions [1] - Ongoing patent litigation against other defendants related to NEXLETOL and NEXLIZET continues, with no assurance on the outcome regarding the marketing of generics before the same date [2] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral, once-daily, non-statin medications for patients at risk of cardiovascular disease with elevated LDL-C levels, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [3] - The company is advancing its pre-clinical pipeline and developing next-generation ATP citrate lyase inhibitors (ACLYi) to create highly potent and specific inhibitors [3][4]
Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-05-12 12:00
Core Insights - Esperion has entered into a settlement agreement with Micro Labs USA, resolving patent litigation related to the generic version of NEXLETOL, preventing Micro Labs from marketing it in the U.S. before April 19, 2040, unless specific circumstances arise [1] - Ongoing patent litigation against other defendants regarding NEXLETOL and NEXLIZET continues, with no assurance of a generic version being marketed before the same date [2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing new medicines for patients at risk of cardiovascular disease, specifically offering FDA-approved oral, once-daily, non-statin medications for elevated LDL-C [3] - The company is advancing its pre-clinical pipeline and aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [4]
Esperion(ESPR) - 2025 Q1 - Earnings Call Presentation
2025-05-06 11:18
Financial Performance - Total revenue reached $65 million, reflecting a 63% increase adjusting for a one-time settlement agreement milestone received in Q1 2024[9] - U S net product sales grew by 41% to $34 9 million[10] - Collaboration revenue was $30 1 million[34] Prescription Trends - Q1 2025 script growth increased by 2% compared to Q4 2024[15, 16] - Early Q2 2025 prescription volume is tracking approximately 8% higher than Q1 2025[16] Market Access and Clinical Validation - The company tripled the U S field reimbursement team to 15 specialists[12] - Over 30 major healthcare plans removed prior authorizations and expanded formulary coverage for NEXLETOL and NEXLIZET[12] Global Expansion - Products are approved in 40 countries globally[21] - Approximately 472,500 patients have been reached internationally through February 2025[24] Pipeline Development - The company is developing a triple combination product with an estimated LDL-C reduction of approximately 60%-70%[19] - A program targeting Primary Sclerosing Cholangitis (PSC) is in development, with an IND planned for 2026, addressing a market opportunity estimated at over $1 billion annually[27, 30]