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NILEMDO (bempedoic acid)
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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 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]