ANN ARBOR, Mich. - Esperion (NASDAQ:ESPR) announced that its partner, Otsuka Pharmaceutical (TADAWUL:2070) Co., Ltd., has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for bempedoic acid, intended for patients with hypercholesterolemia and familial hypercholesterolemia. This drug, which inhibits a cholesterol synthesis enzyme in the liver, is already available in the United States and Europe.
The application is based on a Japanese Phase 3 trial, which demonstrated a significant reduction in LDL cholesterol levels among participants who received bempedoic acid compared to those who received a placebo. The study showed a -25.25 percent change in the bempedoic acid group versus -3.46 percent in the placebo group after 12 weeks of treatment.
The safety profile of bempedoic acid was consistent with previous trials, with no serious adverse events reported. This could represent a new option for patients who have an insufficient response to statins or who are intolerant to them.
Esperion gained attention in 2020 when Otsuka acquired exclusive rights to develop and commercialize bempedoic acid in Japan. The drug's potential approval in Japan could expand treatment options for patients with elevated cholesterol levels who are at risk for cardiovascular diseases.
Esperion is focused on developing medicines for cardiovascular and cardiometabolic diseases. Despite its forward-looking statements about marketing strategies and commercialization plans, the company's projections are subject to the usual risks and uncertainties inherent in drug development and commercialization.
This news is based on a press release statement from Esperion and does not imply endorsement of the drug's efficacy or safety. The company has not provided any guidance on the expected timing of the Japanese regulatory decision.
In other recent news, Esperion Therapeutics has reported a strong third quarter in 2024, marked by significant growth in revenue and prescription rates. The company announced a 53% year-over-year increase in U.S. net product revenue, totaling $31.1 million. Total (EPA:TTEF) revenue also saw an increase, rising to $51.6 million from $34 million in the previous year. This growth is fueled by the expansion of their product labels, strategic partnerships, and an expansion of payer coverage to over 165 million patient lives.
Esperion has also successfully monetized European royalties, repaid debts, and reported a 17% increase in total retail prescription equivalents. The company's international partnerships are growing, with royalty revenue up by 19%. Despite facing gross-to-net headwinds, the company has successfully expanded the labels for its products, NEXLETOL and NEXLIZET.
Looking ahead, Esperion anticipates further growth in prescription rates and is focused on U.S. label expansion and strengthening global partnerships. As these are recent developments, investors should keep a close eye on the company's performance in the coming months.
InvestingPro Insights
Esperion's recent announcement of its partner's NDA submission in Japan aligns with the company's growth trajectory, as highlighted by InvestingPro data. The company's revenue growth of 187.12% over the last twelve months and 52.0% in the most recent quarter suggests strong market traction for its existing products. This momentum could be further bolstered by potential approval in the Japanese market.
InvestingPro Tips indicate that analysts anticipate sales growth in the current year, which is consistent with the company's expansion efforts into new markets like Japan. Additionally, the strong return of 105.6% over the last year reflects investor optimism about Esperion's prospects.
However, it's worth noting that despite the revenue growth, Esperion is not currently profitable. An InvestingPro Tip points out that analysts do not anticipate the company will be profitable this year. This is not uncommon for biotech companies in growth phases, especially those expanding into new markets.
The company's gross profit margin of 63.64% indicates a strong ability to convert revenue into profit before accounting for other costs, which could be crucial as Esperion looks to capitalize on potential new market opportunities.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide deeper insights into Esperion's financial health and market position.
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