NEXLIZET (bempedoic acid and ezetimibe)
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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] - Total preliminary revenue is expected to be between $400 million and $408 million, marking a 20% to 23% increase from 2024, and a 55% to 59% increase when excluding one-time milestones [1] - The company introduced its Vision 2040 growth strategy, aiming to evolve into a multi-product, sustainable, innovation-driven global pharmaceutical company [2][4] Financial Performance - Esperion's cash and cash equivalents at year-end 2025 are approximately $168 million [1] - The company expects operating expenses for full-year 2026 to be between $210 million and $245 million [1][14] - A capital raise of $75 million was completed in 2025 to enhance financial flexibility [14] Product and Market Strategy - The U.S. commercial strategy focuses on NEXLETOL and NEXLIZET, which are approved for cardiovascular disease prevention [7] - Esperion's commercialization efforts are targeting the statin intolerant or resistant market, which constitutes about 30% of the overall market [8] - The company plans to introduce two triple combination products that could lower LDL-C by over 60%, potentially rivaling existing therapies [11] Global Expansion - Esperion has expanded its bempedoic acid products to over 30 countries in the EU, treating more than 600,000 patients [12] - The company has secured regulatory approvals in key markets, including France and Japan, enhancing its global footprint [12][16] R&D Pipeline - Esperion is advancing its ACLY-focused pipeline, targeting multiple life-threatening diseases with next-generation inhibitors [13] - The company nominated ESP-2001 for preclinical development, which addresses primary sclerosing cholangitis and represents a potential market opportunity exceeding $1 billion annually [17] Strategic Initiatives - Esperion has reached settlement agreements with four key ANDA filers to restrict generic entry until April 2040, strengthening its market position [11] - The company has enhanced access and reimbursement support for its products, achieving over 90% coverage among commercial lives and Medicare beneficiaries [11]
Esperion Partner HLS Therapeutics Announces Approval of NILEMDO® for the Reduction of LDL-Cholesterol in Canadians at Risk of Cardiovascular Disease
Globenewswire· 2025-11-18 12:00
Core Insights - Esperion's partner HLS Therapeutics has received approval from Health Canada to market NILEMDO for LDL-Cholesterol reduction in Canadians at risk of cardiovascular disease, with a commercial launch expected in Q2 2026 [1][2]. Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing innovative therapies for patients with elevated LDL-C and cardiovascular disease risk, including the only FDA-approved oral, once-daily, non-statin medications [4]. - The company is advancing its next-generation program aimed at developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design [4]. Market Context - Approximately 2.6 million Canadian adults are diagnosed with heart disease, making it the second leading cause of death in Canada, with 14 adults dying every hour due to this condition [3].
Esperion Appoints Industry Veteran John Harlow as Chief Commercial Officer
Globenewswire· 2025-11-04 13:00
Core Insights - Esperion has appointed John Harlow as Chief Commercial Officer, effective November 17, 2025, to enhance sales and marketing performance during a critical growth phase for the company [1][2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing innovative medicines for patients at risk of cardiovascular disease, specifically targeting elevated low-density lipoprotein cholesterol (LDL-C) [5] - The company has developed the only FDA-approved oral, once-daily, non-statin medications for this patient group, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [5] Leadership Appointment - John Harlow brings over two decades of senior leadership experience in the pharmaceutical industry, having previously served as Chief Commercial Officer at Melinta Therapeutics, where he nearly doubled revenue with an 85% growth in 2024 compared to 2020 [2] - Harlow's extensive background includes roles at Baudax Bio, Recro Pharma, Endo Pharmaceuticals, Shionogi USA, Pfizer, Alpharma, and Novartis, as well as experience as an equity research analyst at Bank of America Merrill Lynch [2] Strategic Goals - Harlow's leadership is expected to drive the expansion of Esperion's product adoption in the U.S. and enhance its global presence, particularly in delivering cardiovascular risk reduction therapies [2][4] - The company aims to leverage Harlow's expertise to accelerate growth and improve access to its therapies, NEXLETOL and NEXLIZET, which are designed to manage cardiovascular risk [4]
Esperion Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-05 10:00
Core Insights - Esperion reported a total revenue growth of 12% year-over-year (Y/Y) to $82.4 million for Q2 2025, with U.S. net product revenue increasing by 42% Y/Y to $40.3 million [1][10][29] - The company achieved its first quarter of operating income from ongoing business, with plans for sustainable profitability starting in Q1 2026 [1][3][12] - Esperion reached settlement agreements with three ANDA filers to prevent the marketing of generic versions of NEXLETOL until 2040, reinforcing its intellectual property [1][5][10] Financial Performance - Total revenue for the six months ended June 30, 2025, was $147.4 million, a decrease of 30% compared to the same period in 2024, but a 69% increase when excluding one-time settlement agreement milestones from 2024 [10][29] - Collaboration revenue decreased by approximately 7% and 54% for the three and six months ended June 30, 2025, respectively, but grew approximately 105% and 102% when excluding settlement agreement milestones [10][29] - The company reported net losses of $4.8 million for Q2 2025, a significant improvement compared to a net loss of $61.9 million in Q2 2024 [8][9][29] Market Strategy and Expansion - Esperion is advancing its U.S. commercial strategy and expanding globally, with expected approval and pricing in Japan in the second half of 2025 [4][10] - The company has established strong branding within the statin intolerant population through a new marketing campaign [5] - Esperion's European partner, Daiichi Sankyo Europe, reported strong revenue growth, surpassing 500,000 patients for NILEMDO and NUSTENDI [10] Operational Highlights - The company increased total retail prescription equivalents by approximately 10% and grew the number of healthcare practitioners writing prescriptions for NEXLETOL and NEXLIZET to over 28,000 in Q2 2025 [5][10] - Research and development expenses decreased by 37% and 20% for the three and six months ended June 30, 2025, respectively, due to reduced costs for ongoing clinical studies [10][29] - Selling, general, and administrative expenses decreased by 11% and 4% for the same periods, primarily due to lower media and marketing costs [10][29]
Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada
Globenewswire· 2025-05-08 10:30
Core Insights - Esperion Therapeutics has entered into a license and distribution agreement with HLS Therapeutics for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Canada, which will enhance access to these cardiovascular therapies for 2.6 million Canadians living with diagnosed heart disease [1][4][2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing non-statin medications for patients at risk for cardiovascular disease, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [7][8] - HLS Therapeutics, established in 2015, specializes in the acquisition and commercialization of late-stage and established pharmaceutical products, particularly in the areas of psychiatric disorders and cardiovascular disease [6] Financial Terms of the Agreement - Under the agreement, Esperion will receive an upfront payment, milestone payments of up to approximately $5 million, and tiered royalties on product sales [5][4] - Esperion will supply finished products to HLS Therapeutics at a profitable transfer price, while HLS will handle commercialization, including reimbursement and marketing [4][5]