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Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-07-08 12:00
ANN ARBOR, Mich., July 08, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Accord Healthcare Inc. This agreement resolves the patent litigation brought by Esperion against Accord Healthcare Inc. in response to Accord Healthcare Inc's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, Accord Healthcare Inc. has agreed ...
Esperion Therapeutics (ESPR) 2022 Earnings Call Presentation
2025-07-03 08:17
WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? FORWARD-LOOKNG STATEMENTS & DISCLOSURES This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, restructuring and current and planned operational expenses, future operations, commercial products, clinical development including the timing, designs and plans for the CLEAR Outcomes study and its resu ...
Esperion Therapeutics (ESPR) 2025 Conference Transcript
2025-06-04 18:27
Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Product**: Bempedoic acid (Nexlazet and Nexlitol) - **Market Position**: Focused on LDL lowering therapies, particularly in primary and secondary prevention of cardiovascular diseases Key Points Industry and Market Dynamics - **Market Expansion**: The new label for bempedoic acid expanded the total addressable market (TAM) from 10 million to 70 million patients, including both secondary and primary prevention indications [5][24] - **Growth Trajectory**: The company reported high single-digit growth in 2021, transitioning to high double-digit growth post-label approval in 2023 [5][19] - **Sales Potential**: Peak sales potential for bempedoic acid is projected to exceed $1 billion [5] Prescription Trends - **Adoption by Physicians**: There is an increasing adoption of bempedoic acid among primary care physicians, with a notable rise in new prescribers [7][8] - **Statin Intolerance**: The drug is being positioned as a solution for patients who cannot tolerate statins, which accounts for up to 30% of patients needing LDL lowering [8][10] Coverage and Access - **Insurance Coverage**: The company has achieved 92% coverage in commercial plans and 72% in Medicare, with significant improvements in approval rates due to the introduction of field reimbursement managers [10][12] - **Removal of Barriers**: The new label has eliminated previous step edits and prior authorization requirements for certain plans, facilitating easier access for patients [10][11] Financial Outlook - **Revenue Growth**: The company anticipates a return to double-digit growth in revenue, with expectations of profitability by Q1 2026, potentially earlier due to milestone payments from Otsuka [19][20] - **Sales Projections**: Consensus estimates for bempedoic acid sales are in the range of $165 million to $170 million for the current year [21] Competitive Landscape - **Future Competition**: The company does not expect significant competition in the LDL lowering space until 2028, allowing for continued market share growth [24][25] - **New Drug Developments**: The CEO expressed cautious optimism regarding new entrants in the market, emphasizing the need for robust clinical data to support efficacy claims [26][30] Intellectual Property and Litigation - **Patent Settlements**: Two out of nine ANDA filers have settled, extending exclusivity until April 2040, with ongoing confidence in the strength of manufacturing patents [34][36] - **Future IP Strategy**: The company is exploring additional extensions of exclusivity through potential partnerships and product combinations [42] Business Development Strategy - **Partnership Opportunities**: Esperion is actively seeking partnerships in the cardiometabolic space, leveraging its existing infrastructure to support the launch of new drugs without significant cash outlay [48][54] - **Focus Areas**: The company is looking at both public and private companies for potential collaborations, particularly in areas with high overlap in call points [56][61] Pipeline Developments - **Research and Development**: The company is advancing its internal pipeline, particularly in primary sclerosing cholangitis and kidney programs, with plans for updates in the near future [62][65] - **External Interest**: There is growing interest from other companies in Esperion's pipeline, indicating potential for future partnerships [68] Conclusion Esperion Therapeutics is positioned for significant growth in the LDL lowering market, driven by the successful launch of bempedoic acid and strategic initiatives to enhance access and adoption among healthcare providers. The company is also exploring partnerships to expand its product offerings while maintaining a strong focus on its internal pipeline developments.
Esperion(ESPR) - 2025 FY - Earnings Call Transcript
2025-05-20 15:00
Esperion Therapeutics (ESPR) FY 2025 Conference May 20, 2025 10:00 AM ET Speaker0 Okay. Welcome back, everybody. My name's Joe Panginas, managing director here at, HC Wainwright. Very happy to have with us Esperion Therapeutics. And, also nice to have the second commercial stage, company that I'm, doing a fireside chat with today. So it's very refreshing in the small cap biotech space, which, you don't necessarily apply to. So presenting for the company is Ben Halliday, chief financial officer. Ben, thank y ...
Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-05-12 12:00
ANN ARBOR, Mich., May 12, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Micro Labs USA, Inc. and its affiliate Micro Labs Limited (together, Micro Labs). This agreement resolves the patent litigation brought by Esperion against Micro Labs in response to Micro Labs’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of NEXLETOL prior to the expiration of the applicable patents. Pursuant to the agreement, ...
Esperion Therapeutics (ESPR) 2025 Conference Transcript
2025-05-08 17:30
Esperion Therapeutics (ESPR) 2025 Conference May 08, 2025 12:30 PM ET Speaker0 I guess take a step back and Primary. I guess take a step back and go go through the data that went into those new labels. Can you just walk us through the clear outcome study and the findings there? Speaker1 So the clear outcome study was a 14,000 patient outcome study which measured MACE four, MACE three in a variety of endpoints in both a, in a non statin population in both a primary and secondary prevention patient population ...
Esperion Partners with HLS Therapeutics to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada
Globenewswire· 2025-05-08 10:30
– Esperion to Receive an Upfront Payment, Near-Term Milestones and Tiered Royalties on Product Sales – – Further Expands Global Access to Bempedoic Acid Products and Provides Opportunity to Bring Innovative Preventative Therapy to 2.6 million Canadians Living with Diagnosed Heart Disease – ANN ARBOR, Mich., May 08, 2025 (GLOBE NEWSWIRE) -- Esperion Therapeutics (NASDAQ: ESPR) today announced it has entered into a license and distribution agreement with HLS Therapeutics (TSX:HLS) for the exclusive rights to ...
Esperion(ESPR) - 2025 Q1 - Earnings Call Transcript
2025-05-06 13:02
Esperion Therapeutics (ESPR) Q1 2025 Earnings Call May 06, 2025 08:00 AM ET Company Participants Alina Venezia - Head of Investor RelationsSheldon Koenig - President & CEOBen Halladay - CFOJason Zemansky - Vice President, Equity Research, Biotechnology and PharmaceuticalsBetty Swartz - Chief Business Officer Conference Call Participants Dennis Ding - Vice President - Equity Research AnalystJoseph Pantginis - MD & Senior Healthcare AnalystKristen Kluska - Equity Research AnalystSerge Belanger - Senior Analys ...
Esperion(ESPR) - 2025 Q1 - Earnings Call Transcript
2025-05-06 12:00
Esperion Therapeutics (ESPR) Q1 2025 Earnings Call May 06, 2025 08:00 AM ET Speaker0 Ladies and gentlemen, thank you for standing by and welcome. At this time, all participants are in a listen only mode. Following the presentation, there will be a question and answer session. Please be advised that today's conference call will be recorded. I would now like to hand the conference over to Alina Venezia, Director of Investor Relations for Esperion Therapeutics. Please go ahead. Speaker1 Thank you, operator. Go ...
Esperion(ESPR) - 2025 Q1 - Earnings Call Presentation
2025-05-06 11:18
Q1 2025 Earnings Presentation May 6, 2025 © 2025 Esperion Therapeutics, Inc. All rights reserved. Forward-looking Statements & Disclosures This investor presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, clinical development, plans for potential future product candida ...