Nexlizet

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ESPR Stock Drops 17% on Pricing of $75M Common Stock Offering
ZACKS· 2025-10-09 14:01
Key Takeaways Esperion priced a 30M-share offering at $2.50, expecting $75M in gross proceeds.ESPR shares fell 17% as investors reacted to the discounted pricing of the new issue.Proceeds will fund Nexletol, Nexlizet expansion, pipeline work and general corporate needs.Esperion Therapeutics (ESPR) recently announced that it is floating a secondary issue of 30 million shares of its common stock to the public at an issue price of $2.50 per share. The company expects to raise approximately $75 million in gross ...
ESPR Settles Nexletol/Nexlizet Patent Litigation With RDY, Stock Up
ZACKS· 2025-10-06 14:56
Key Takeaways Esperion reached a settlement with Dr. Reddy's over patents for Nexletol and Nexlizet.RDY agreed not to launch U.S. generics of the drugs before April 19, 2040, under the deal.The settlement resolves remaining disputes with RDY tied to Esperion's key bempedoic acid patent.Esperion Therapeutics (ESPR) announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories (RDY) related to patents for the marketed drugs, Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ...
Esperion Therapeutics (ESPR) 2025 Conference Transcript
2025-09-03 14:47
Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Focus**: Commercialization of life-saving medications, specifically Nexlizet and Nexletol, with ongoing development of new compounds [7][8][60] Key Points Industry Context - **Cardiovascular Disease**: Identified as the number one killer globally, emphasizing the need for effective lipid-lowering therapies [10][12][43] - **Statin Intolerance**: Approximately 30% of patients cannot tolerate statins, creating a significant market opportunity for alternative therapies like Nexlizet [19][36] Product Performance - **Growth Metrics**: Double-digit growth reported in all metrics for Q2, indicating strong market momentum [7] - **Combination Therapy**: Emphasis on the need for combination therapies to achieve LDL-C goals, with Nexlizet showing 38% additional efficacy when added to statins [19][28] Market Strategy - **Geographic Expansion**: Strong traction in Europe, with potential for similar success in the U.S. and Japan, where statin intolerance is prevalent [31][32] - **Guideline Influence**: Received a Class 1A recommendation in new guidelines, positioning bempedoic acid as a foundational therapy [34][35][49] Financial Outlook - **Positive Financial Trajectory**: Achieved positive operating income for the first time from ongoing operations, with expectations for full profitability by Q1 2026 [67][68] - **Cash Position**: Ample cash reserves and reduced debt profile, supporting ongoing growth initiatives [69] Future Developments - **New Indications**: Exploring treatment for primary sclerosing cholangitis (PSC), with confidence in the unique mechanism of action of their compounds [60][62] - **Triple Oral Combination**: Development of a triple oral combination therapy expected to enhance LDL-C reduction efficacy [38][39] Consumer Engagement - **Marketing Initiatives**: Upcoming consumer-directed commercials aimed at educating patients about heart health and the importance of treatment adherence [25][27] Competitive Landscape - **Market Positioning**: While competition exists, the unique efficacy and combination potential of Nexlizet provide a strong market position [45][46] Additional Insights - **Patient Education**: Importance of educating patients about their cardiovascular risk to encourage adherence to treatment [21][22] - **Regulatory Milestones**: Anticipated regulatory approvals in Japan tied to significant financial milestones, indicating a robust partnership with Otsuka [70][71] This summary encapsulates the key insights from the conference call, highlighting Esperion Therapeutics' strategic focus, market opportunities, and financial health.
ESPR's Q2 Earnings & Revenues Trump Estimates, Stock Rises
ZACKS· 2025-08-06 16:45
Financial Performance - Esperion Therapeutics (ESPR) reported a loss of $0.02 per share in Q2 2025, significantly better than the Zacks Consensus Estimate of a loss of $0.17 and an improvement from a loss of $0.05 in the same quarter last year [1][6] - Total revenues for Q2 reached $82.4 million, marking a 12% year-over-year increase and surpassing the Zacks Consensus Estimate of $66 million [1][6] - U.S. product revenues totaled $40.3 million, up 42% year-over-year, exceeding the Zacks Consensus Estimate of $35.1 million [4][6] Revenue Breakdown - Collaboration revenues, which include royalties and partner revenues, amounted to $42.1 million, down nearly 7% year-over-year due to a milestone payment recorded in the previous year, but excluding this, collaboration revenues surged approximately 105% year-over-year [7][8] - The company achieved its first-ever operating income from ongoing business operations in Q2 2025 [9] Cost Management - Research and development expenses decreased by 37% year-over-year to $7.2 million, reflecting reduced costs in ongoing clinical studies [8] - Selling, general, and administrative expenses fell by 11% year-over-year to $39.5 million due to lower media and marketing costs [8] Future Outlook - Esperion expects operating expenses for 2025 to be in the range of $215-$235 million, including $15 million in non-cash stock compensation expenses [10] - The company anticipates achieving sustainable profitability starting in Q1 2026 [10] Recent Developments - Esperion reached settlement agreements with three ANDA filers regarding patents for Nexletol, preventing the marketing of generic versions until 2040, which is expected to protect future U.S. sales [11]
ESPR's Q1 Earnings Miss Estimates, Revenues Beat, Stock Down
ZACKS· 2025-05-07 17:10
Core Insights - Esperion Therapeutics reported a loss of 21 cents per share in Q1 2025, which was wider than the Zacks Consensus Estimate of a loss of 18 cents, compared to earnings of 34 cents per share in the same quarter last year [1] - Total revenues for Esperion in Q1 2025 were $65 million, reflecting a 53% year-over-year decline, primarily due to a one-time milestone payment received in Q1 2024; however, revenues exceeded the Zacks Consensus Estimate of $58 million [2] - The company's stock fell 7.1% on May 6 following the earnings announcement and has decreased 55.7% year-to-date, contrasting with a 0.4% decline in the industry [3] Financial Performance - Product revenues from the U.S. totaled $34.9 million in Q1 2025, up 41% year-over-year, driven by expanded label and commercial initiatives; this figure surpassed the Zacks Consensus Estimate of $29.8 million [5] - Collaboration revenues, including royalties and partner revenues, were $30.1 million, down almost 73% year-over-year, but beat the Zacks Consensus Estimate of $27.9 million [8] - Research and development expenses decreased by 6% to $12.6 million, while selling, general, and administrative expenses rose by 2% to $43 million due to increased marketing and consulting costs [8][9] Future Outlook - Esperion expects operating expenses for 2025 to be in the range of $215-$235 million, which includes $15 million in non-cash expenses related to stock compensation [10] - The company is developing two triple combination products with Nexletol/Nexlizet, expected to launch in 2027, which may offer LDL-C lowering of more than 60% [11] - Esperion is also planning to develop ESP-1336 for the treatment of primary sclerosing cholangitis (PSC), a market estimated to exceed $1 billion annually [12]
Esperion Therapeutics (ESPR) Update / Briefing Transcript
2025-01-22 18:30
Summary of the Conference Call Company and Industry - **Company**: Esperion Therapeutics - **Industry**: Cardiovascular Disease Treatment, specifically focusing on lipid-lowering therapies Key Points and Arguments 1. **Unmet Need in Cardiovascular Disease**: Atherosclerotic cardiovascular disease is the leading cause of death globally, with 44% of US adults affected. Over half of these patients do not meet LDL-C goals, and 30% may be unable or unwilling to take statins [7][8][9]. 2. **Clinical Development of Bempedoic Acid**: Esperion's clinical trials for bempedoic acid focused on patients with unmet needs, including those with statin intolerance and primary prevention patients. The trials included a combination of bempedoic acid with low-dose statins and a fixed combination with Ezetimibe [8][10][11]. 3. **Phase Three Trials**: Five placebo-controlled Phase Three trials demonstrated significant reductions in LDL cholesterol and high-sensitivity C-reactive protein (hsCRP) across various patient populations, including those with cardiovascular disease and statin intolerance [11][12][13]. 4. **Clear Outcomes Study**: This unique trial validated that bempedoic acid reduces cardiovascular risk by lowering LDL cholesterol. It included both primary and secondary prevention patients and showed a 13% relative risk reduction in major adverse cardiovascular events (MACE) [12][13][14]. 5. **Safety Profile**: Bempedoic acid was generally well tolerated, with a safety profile similar to placebo. Myalgia was the most common side effect, but the incidence was lower than with statins [22][23]. 6. **Market Positioning**: Bempedoic acid is the only non-statin FDA-approved drug with data in primary prevention patients, addressing a significant unmet need in cardiovascular risk reduction [25][26]. 7. **Real-World Experience**: Doctor Moriarty emphasized the importance of early intervention in atherosclerosis and noted that bempedoic acid has been effective in managing patients with statin intolerance, achieving up to a 40% reduction in LDL [50][52]. 8. **Patient Preferences**: There is a strong preference among patients for oral therapies over injectables due to convenience and cost considerations [55][56]. 9. **Future Directions**: The potential for combining bempedoic acid with statins and other therapies is being explored, with ongoing studies to assess the efficacy of triple combination therapies [86][90]. Other Important but Possibly Overlooked Content 1. **Educational Gaps**: There is a lack of awareness among some healthcare providers regarding the benefits and availability of bempedoic acid, which may hinder its adoption [96][97]. 2. **Inflammation and Cardiovascular Risk**: The discussion highlighted the importance of addressing inflammation in cardiovascular disease, with bempedoic acid showing promise in lowering inflammatory markers like hsCRP and RDW [46][48][49]. 3. **Cost Considerations**: The cost of therapies remains a significant factor in prescribing practices, with generics being preferred due to their affordability [76][90]. This summary encapsulates the key insights from the conference call, focusing on the clinical development, market positioning, and real-world application of bempedoic acid in treating cardiovascular disease.