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ANN ARBOR, Mich. - Esperion (NASDAQ:ESPR), a $330 million market cap pharmaceutical company whose stock has surged over 11% in the past week, has secured a regulatory path with the U.S. Food and Drug Administration (FDA) to initiate Phase 3 clinical trials for its cholesterol-lowering drug bempedoic acid, both alone and in combination with ezetimibe, targeting pediatric patients with familial hypercholesterolemia (FH). According to InvestingPro data, the company has demonstrated remarkable revenue growth of 186% over the last twelve months. The company announced its plans to begin these trials within the current year after confirming sufficient data from its Phase 2 studies. While InvestingPro analysis shows the company operates with significant debt and isn’t currently profitable, its strong gross profit margin of 65% suggests efficient core operations.
Familial hypercholesterolemia is a genetic disorder characterized by high cholesterol levels from birth, leading to a higher risk of cardiovascular disease. It comes in two forms: heterozygous FH (HeFH), which affects 1 in 250 births, and the rarer homozygous FH (HoFH), occurring in 1 in 300,000 births. Bempedoic acid has been granted orphan drug designation by the FDA for its potential in treating HoFH.
The upcoming CLEAR Path 2 and CLEAR Path 3 studies will evaluate the efficacy and safety of bempedoic acid over a one-year period. These randomized, double-blind, placebo-controlled trials will involve a 24-week treatment phase followed by a 28-week open-label extension. The studies aim to include children with HeFH or HoFH and LDL-C levels of ≥130 mg/dL while on an optimal dose of a statin.
Sheldon Koenig, President and CEO of Esperion, expressed satisfaction with the FDA’s indication that the company’s data is adequate to proceed into Phase 3 clinical trials. Additionally, this agreement aligns with Esperion’s lifecycle management plan, potentially extending patent protection for bempedoic acid products by an additional six months, through June 2031.
Esperion Therapeutics focuses on developing non-statin, oral, once-daily medications for patients at risk for cardiovascular disease with elevated low-density lipoprotein cholesterol (LDL-C). The company emphasizes the importance of early detection and treatment of FH to control LDL cholesterol levels and reduce cardiovascular risk.
The information in this article is based on a press release statement and is intended to provide an overview of Esperion’s recent developments without offering opinions or recommendations. For a comprehensive analysis of Esperion’s financial health and future prospects, including additional ProTips and detailed metrics, explore the full company research report available on InvestingPro, which covers over 1,400 US stocks with deep-dive analysis and actionable insights.
In other recent news, Esperion Therapeutics reported a significant revenue increase of 114% year-over-year for the fourth quarter of 2024, reaching $69.1 million and surpassing the forecast of $63.45 million. The company’s earnings per share (EPS) was reported at -$0.11, which was better than the anticipated -$0.14. This robust performance was driven by a 52% increase in U.S. net product revenue and a 227% surge in collaboration revenue. Esperion ended the fiscal year 2024 with approximately $145 million in cash, positioning the company well for future investments.
Esperion’s revenues were buoyed by a milestone payment from its Japanese partner Otsuka, despite U.S. net product sales for the quarter falling short of expectations. The company experienced a 12% sequential demand growth, although this was partially offset by the effects of the Medicare coverage gap. Management anticipates that the impact of the Medicare coverage gap on earnings will be a one-time event, with net revenue expected to better reflect demand growth in 2025. Esperion expanded its healthcare provider base by 10% and increased payer access to 173 million lives in the U.S.
Analysts at JMP maintained their Market Outperform rating and a $4.00 price target for Esperion, citing confidence in the company’s growth trajectory and ongoing U.S. commercialization efforts. The company is also exploring new therapeutic opportunities and developing triple combination products aimed at reducing LDL cholesterol by over 60%. Esperion anticipates more consistent revenue growth in 2025, with plans to expand its market presence in Japan, Israel, and Canada.
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