ANN ARBOR, Mich. - Esperion (NASDAQ:ESPR) has announced final results from the MILOS study conducted by its European partner, Daiichi Sankyo Europe (DSE), showing significant reductions in LDL-C levels among patients treated with bempedoic acid, alone or in combination with ezetimibe. The study, which followed 973 patients over two years, observed an average 30.3% reduction in LDL-C levels, with a 7-fold increase in patients achieving their LDL-C goals.
The findings, presented at DGK Herztage 2024 in Hamburg, Germany, highlight the effectiveness of the treatments in real-world settings, echoing the safety profile seen in the CLEAR clinical trial program. Bempedoic acid, marketed as NILEMDO® in the EU and NEXLETOL® in the U.S., along with its combination with ezetimibe, marketed as NUSTENDI® in the EU and NEXLIZET® in the U.S., are used to manage primary hypercholesterolemia or mixed dyslipidemia.
Of the study cohort, 451 patients had complete LDL-C level data available for the two-year period, showing a mean reduction from 3.1 mmol/L (121.4 mg/dL) to 2.0 mmol/L (77.2 mg/dL). The proportion of high-risk and very high-risk patients reaching LDL-C goals increased significantly by the end of the study.
Professor Ioanna Gouni-Berthold, an author of the study, emphasized the importance of reducing LDL-C levels to lower the risk of cardiovascular events. Sheldon Koenig, President and CEO of Esperion, expressed satisfaction with the adoption of bempedoic acid in Europe and its potential market opportunity in the United States.
The bempedoic acid component of NEXLIZET and NEXLETOL is indicated for reducing the risk of cardiovascular events in adults who cannot take recommended statin therapy and as an adjunct to diet to reduce LDL-C levels. The safety information for these medications includes warnings about potential hypersensitivity reactions, hyperuricemia, and tendon rupture or injury.
The study's results contribute to the clinical evidence supporting the therapeutic role of bempedoic acid in achieving LDL-C goals, particularly relevant as cardiovascular disease remains a leading cause of death in Europe and the U.S. This article is based on a press release statement.
In other recent news, Esperion Therapeutics Inc. has reported robust growth in its Q2 earnings, with a significant increase in revenue primarily driven by the successful commercialization of its cardiovascular therapies, NEXLETOL and NEXLIZET. The company's U.S. net product revenue saw a 39% increase, while the total Q2 revenue reached $73.8 million, marking a 727% rise in collaboration revenue. This growth is attributed to expanded labels and a wider patient population.
Esperion has also strengthened its financial position through a transaction that monetized the European royalty stream. The company is planning to further its reach internationally, with imminent plans to file a new drug application in Japan through its partner, Otsuka Pharmaceutical. These are the latest developments in the company's operations, which have not only improved financial stability but also set the stage for continuous growth within the cardiovascular market.
It's worth noting that Esperion is performing on par or even ahead of competitors in the cardiovascular sector, experiencing steady growth and momentum with their product launches. However, the company did not disclose specific gross to net numbers, maintaining that they are in a steady state. As for future expectations, analysts anticipate that the company's partnerships in Europe and Japan will significantly contribute to their international expansion efforts.
InvestingPro Insights
The positive results from the MILOS study for Esperion's (NASDAQ:ESPR) bempedoic acid treatments align with some encouraging financial metrics from InvestingPro. The company's revenue growth is particularly noteworthy, with a 215.98% increase over the last twelve months as of Q2 2023, and a 186.33% quarterly growth in Q2 2023. This robust revenue expansion could be attributed to the growing adoption of bempedoic acid treatments in Europe, as mentioned by CEO Sheldon Koenig.
However, investors should note that despite the revenue growth, Esperion is not yet profitable. An InvestingPro Tip indicates that analysts do not anticipate the company will be profitable this year. This aligns with the company's current focus on market expansion and clinical studies, which often precede profitability in the biotech sector.
Another relevant InvestingPro Tip suggests that analysts anticipate sales growth in the current year, which could be driven by the positive clinical results and potential market opportunities highlighted in the article. For those seeking a more comprehensive analysis, InvestingPro offers 5 additional tips that could provide further insights into Esperion's financial health and market position.
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