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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
ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and N ...
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]