ANN ARBOR, Mich. - Esperion (NASDAQ: NASDAQ:ESPR), which has seen remarkable revenue growth of 187% over the last twelve months, has submitted New Drug Submissions to Health Canada for two cholesterol-lowering medications, NEXLETOL and NEXLIZET, the company announced today. These oral, non-statin drugs are designed to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.
The company's President and CEO, Sheldon Koenig, expressed optimism about the potential impact of these medications, citing heart disease as a leading cause of death worldwide. In Canada, heart disease ranks as the second leading cause of death, with about 2.6 million adults living with diagnosed heart disease, according to the Public Health Agency of Canada. According to InvestingPro data, Esperion's stock has shown strong momentum with a 94% return over the past year, while analysts anticipate continued sales growth in the current year.
Esperion's NEXLIZET and NEXLETOL are indicated for adults who cannot take statins, with established cardiovascular disease or at high risk for a cardiovascular event. They are also meant as an adjunct to diet for reducing LDL-C in adults with primary hyperlipidemia, including Heterozygous Familial Hypercholesterolemia (HeFH).
Despite the potential benefits, there are important safety considerations for these medications. They are not suitable for patients with a known hypersensitivity to bempedoic acid or ezetimibe, which are active ingredients in both drugs. Reported side effects include upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain, and tendon rupture, among others.
Esperion emphasizes the importance of monitoring patients for signs of hyperuricemia and gout, and advises discontinuation of the drugs at the first sign of tendon rupture. The company also recommends against the use of NEXLIZET or NEXLETOL during pregnancy and breastfeeding unless the benefits outweigh potential risks.
This announcement is based on a press release statement from Esperion, which is known for developing innovative medicines to address cardiovascular and cardiometabolic diseases. The company's mission is to offer additional treatment options to help patients achieve their cholesterol management goals. With a healthy gross profit margin of 64% and a current ratio of 1.85, InvestingPro analysis reveals 10+ additional exclusive insights about Esperion's financial health and market position. Access the comprehensive Pro Research Report for deeper analysis of this emerging pharmaceutical company.
Investors and patients are now awaiting Health Canada's decision on the approval of these new treatment options.
In other recent news, Esperion Therapeutics has made substantial strides in the pharmaceutical industry. The company's new cholesterol drug, bempedoic acid, has submitted a New Drug Application in Japan, following a successful Phase 3 trial. The trial demonstrated a significant reduction in LDL cholesterol levels among participants, suggesting its potential as a new treatment option for patients with hypercholesterolemia and familial hypercholesterolemia.
Esperion's financial performance has also been noteworthy, with a 53% year-over-year increase in U.S. net product revenue, totaling $31.1 million in the third quarter of 2024. Total (EPA:TTEF) revenue rose to $51.6 million, up from $34 million in the previous year. This growth was driven by the expansion of their product labels, strategic partnerships, and an expansion of payer coverage to over 165 million patient lives.
The company has also successfully monetized European royalties, repaid debts, and reported a 17% increase in total retail prescription equivalents. Despite facing gross-to-net headwinds, Esperion has expanded the labels for its products, NEXLETOL and NEXLIZET. These are recent developments that investors should closely monitor in the coming months.
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