NEXLIZET

Search documents
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
Core Insights - Esperion has entered into a settlement agreement with Accord Healthcare Inc. to resolve patent litigation regarding the generic version of NEXLETOL, preventing Accord from marketing it in the U.S. before April 19, 2040, under certain conditions [1] - Ongoing patent litigation against other defendants related to NEXLETOL and NEXLIZET continues, with no assurance on the outcome regarding the marketing of generics before the same date [2] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral, once-daily, non-statin medications for patients at risk of cardiovascular disease with elevated LDL-C levels, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [3] - The company is advancing its pre-clinical pipeline and developing next-generation ATP citrate lyase inhibitors (ACLYi) to create highly potent and specific inhibitors [3][4]
Esperion Reaches Settlement Agreement with Second ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-06-02 12:00
Core Insights - Esperion has entered into a settlement agreement with Hetero USA, resolving patent litigation related to the generic version of NEXLETOL, preventing Hetero USA from marketing the generic in the U.S. before April 19, 2040, unless specific circumstances arise [1] - Ongoing patent litigation against other defendants regarding NEXLETOL and NEXLIZET continues, with no assurance on the outcome or potential market entry of generics before the 2040 date [2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing new medicines for patients at risk for cardiovascular disease, specifically offering FDA-approved oral, once-daily, non-statin medications for elevated LDL-C [3] - The company is advancing its next-generation program aimed at developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design and the creation of potent inhibitors [3][4] - Esperion is evolving into a leading global biopharmaceutical company through commercial execution, international partnerships, collaborations, and the advancement of its pre-clinical pipeline [4]
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
Core Insights - Esperion has entered into a settlement agreement with Micro Labs USA, resolving patent litigation related to the generic version of NEXLETOL, preventing Micro Labs from marketing it in the U.S. before April 19, 2040, unless specific circumstances arise [1] - Ongoing patent litigation against other defendants regarding NEXLETOL and NEXLIZET continues, with no assurance of a generic version being marketed before the same date [2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing new medicines for patients at risk of cardiovascular disease, specifically offering FDA-approved oral, once-daily, non-statin medications for elevated LDL-C [3] - The company is advancing its pre-clinical pipeline and aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [4]
Esperion(ESPR) - 2024 Q4 - Earnings Call Transcript
2025-03-04 15:34
Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $69.1 million, an increase of 114% compared to $32.3 million in Q4 2023 [28] - U.S. net product revenue was $31.6 million, up approximately 52% from $20.8 million in the same period last year [28] - Collaboration revenue increased approximately 227% to $37.6 million compared to $11.5 million in Q4 2023 [29] - Research and development expenses decreased by 38% to $11 million from $17.7 million in Q4 2023 [30] - Selling, general and administrative expenses decreased by 19% to $36.9 million from $45.4 million in Q4 2023 [30] - Cash and cash equivalents stood at $144.8 million as of December 31, 2024 [31] Business Line Data and Key Metrics Changes - The company achieved 12% sequential quarterly growth in total retail prescription equivalents (TRPEs) in Q4 2024 compared to Q3 2024 [10] - The prescriber base increased by 10% from the previous quarter, reaching over 25,000 healthcare providers [10] - Royalty revenue from DSE increased 9% sequentially to $9.7 million in Q4 2024, with a full-year increase of 116% to $32.6 million [15] Market Data and Key Metrics Changes - The company expanded payer access to over 173 million lives covered in the U.S. [10] - Approximately 453,000 patients have been treated with the company's therapies in Europe, representing 19% sequential growth over the past three months [16] Company Strategy and Development Direction - The company focuses on three strategic pillars: continued revenue growth, operating profitability, and portfolio expansion [9] - Plans to introduce triple combination products in the U.S. to address statin intolerance and expand market presence [12] - The company is actively exploring new therapeutic opportunities and developing next-generation inhibitors for serious diseases [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth and operational flexibility due to a strengthened financial structure [8] - Anticipated Medicare reforms are expected to improve revenue growth alignment with TRPE growth [29] - The company is optimistic about the impact of expanded product access and ongoing clinical data presentations on future sales [20][21] Other Important Information - The company entered into a licensing agreement with Neopharm Israel for exclusive rights to commercialize NEXLETOL and NEXLIZET in Israel [19] - A partnership with CSL Seqirus was established to commercialize NEXLETOL and NEXLIZET in Australia and New Zealand [17] Q&A Session Summary Question: What is the regulatory path for the triple combo in the U.S.? - Management indicated that no additional details would be provided at this time, but a CVOT is not necessary [42] Question: Can U.S. bempedoic acid revenue in 2025 see accelerated growth? - Management expects a more consistent translation of RPE growth to revenue growth due to improved access and reduced gross to net pressure [46] Question: How are efforts to build efficiencies into COGS progressing? - COGS has remained consistent, with ongoing evaluations to drive costs down [50] Question: What feedback is being received from prescribers? - Positive feedback is noted regarding the efficacy of the products, with ongoing education efforts to improve coverage awareness [55] Question: What is the status of potential in-licensing discussions? - The company is conducting a landscape analysis for potential products and is excited about leveraging its existing infrastructure [60] Question: How does the company view the opportunity to help sell other products? - The company sees significant potential in commercializing or acquiring assets due to its established commercial infrastructure [66] Question: What are the expectations for the triple combination products? - The triple combination is viewed as complementary to the existing portfolio, with a focus on lowering LDL and improving patient outcomes [75] Question: How familiar are prescribers with bempedoic acid? - Awareness among healthcare providers is improving, with high aided awareness reported [86] Question: Will the Medicare contract impact linger into 2025? - Management does not expect lingering impacts from the Medicare contract changes [93] Question: What is the development timeline for the triple products? - More information on development timelines will be shared in the fall [81]