ANN ARBOR, Mich., Oct. 03, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laboratories Ltd. (together, Dr. Reddy’s Laboratories). This agreement resolves the patent litigation brought by Esperion against Dr. Reddy’s Laboratories in response to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of each of NEXLETOL and N ...

Company Overview - Esperion Therapeutics is focused on commercializing life-saving medications, specifically NEXLIZET and NEXLETOL [3] - The company is also developing additional life-saving medications, with a recent R&D Day highlighting interesting compounds [3] Financial Performance - Esperion reported significant momentum in its Q2 results, showing double-digit growth across all metrics [3] Industry Engagement - The company had a successful presence at the European Society of Cardiology, which positively influenced its guidelines [3]

Core Insights - Bempedoic acid has received strong endorsement from the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines as the only non-statin recommended for lowering LDL-C and reducing cardiovascular risk [1][4] - The guidelines emphasize an early and aggressive approach to combination lipid-lowering therapy, which aligns with the company's strategy to develop oral triple combination therapies in the U.S. [1][5] Company Developments - Esperion's President and CEO highlighted the significance of the guideline recognition for both European and U.S. markets, indicating that it will inform upcoming U.S. cholesterol treatment guidelines [2] - The company is strategically positioned to lead in the development of the first oral lipid-lowering triple combination pill in the U.S., which aims to provide unprecedented LDL-C lowering and improved patient adherence [5][16] Product Information - NEXLIZET and NEXLETOL are indicated for patients unable to take statin therapy, with bempedoic acid recommended for achieving LDL-C goals [6][7] - The guidelines recommend the addition of bempedoic acid to maximally tolerated doses of statins for high-risk patients to achieve LDL-C goals [6] Clinical Evidence - The clinical benefits of bempedoic acid are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial, which validates its role in cardiovascular risk reduction [16]

Core Insights - Esperion Therapeutics reported higher-than-expected GAAP results for Q2 2025, with revenue of $82.4 million, surpassing analyst estimates of $63.05 million, and a narrowed GAAP EPS loss of $0.02 compared to the expected loss of $0.15 [1][2][12] - The company achieved positive operating income from ongoing operations for the first time, indicating progress towards sustainable profitability [1][7] Financial Performance - GAAP revenue increased by 11.6% year-over-year from $73.8 million in Q2 2024 to $82.4 million in Q2 2025 [2] - U.S. net product revenue rose 42.4% year-over-year to $40.3 million, reflecting strong uptake of NEXLETOL and NEXLIZET [2][5] - Collaboration revenue decreased by 7.4% year-over-year to $42.1 million, but recurring collaboration revenue more than doubled compared to Q2 2024 [2][6] - Operating expenses declined by 5.5% year-over-year to $67.4 million, with R&D expenses dropping 37% [2][7] Product and Market Strategy - Esperion focuses on developing oral therapies for cholesterol management, particularly for patients who cannot tolerate statins, with NEXLETOL and NEXLIZET as its main products [3][10] - The company aims to expand market reach through new regulatory approvals and updated treatment guidelines, emphasizing physician acceptance and insurance coverage [4][10] - Recent prescription activity increased, with a 10% rise in retail prescriptions filled compared to the previous quarter [5] Collaboration and International Growth - Collaboration revenue, which includes royalties and milestone payments, constituted over half of total revenue, with significant contributions from partnerships like Daiichi Sankyo [6] - Over 500,000 European patients have received Esperion's therapies through its partnership with Daiichi Sankyo, with further international approvals expected in Japan, Canada, Israel, and Australia [6][12] Future Outlook - The company has a cash balance of $86.1 million as of June 30, 2025, down from $144.8 million at the end of 2024, with management focused on achieving sustainable profitability by early 2026 [12][13] - Esperion is developing a triple-combination oral therapy for LDL-C lowering, expected to launch in 2027, which aims to provide high-efficacy cholesterol reduction in a single tablet [11]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 grew 12% year over year to $82.4 million, despite a $25 million one-time milestone payment in Q2 2024, indicating strong underlying business performance [20][21] - U.S. net product revenue increased 42% year over year to $40.3 million and grew 15% sequentially [21] - Operating income from ongoing business reached approximately $15 million, marking the first quarter of operating income in the company's history [5][19] Business Line Data and Key Metrics Changes - Collaboration revenue decreased by approximately 7% to $42.1 million, impacted by a settlement agreement milestone with DSC, but grew 105% when excluding this milestone [21][22] - Research and development expenses decreased by 37% to $7.25 million, while selling, general, and administrative expenses decreased by 11% to $39.5 million [22] Market Data and Key Metrics Changes - The company reported over 650,000 visits to its consumer statin intolerance website and more than 600,000 click-throughs to its physician site during Q2 [8] - The total prescriber base increased to over 28,000 healthcare practitioners, with a 10% increase in total retail prescription equivalents [10][21] Company Strategy and Development Direction - The company is focused on expanding its cardiovascular risk reduction portfolio, including plans to develop a triple combination product [12][13] - The marketing strategy emphasizes reaching statin intolerant patients, with successful campaigns like "Can't take a statin, make NexoZet happen" driving brand awareness [7][12] - The company aims to transition to sustainable profitability starting in 2026, supported by strong operational results and global growth [19][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustainable profitability due to strong performance and ongoing global growth [19][25] - The endorsement of NEXLETOL and NEXLASET by leading cardiovascular professional societies is seen as a validation of the company's science and marketing efforts [7][12] - Management highlighted the importance of digital marketing and consumer engagement in driving growth and awareness [9][11] Other Important Information - The company reached settlement agreements with three generic manufacturers to delay the marketing of generic versions of Nexletol until February 2040 [13] - The company is advancing its pipeline, including a program targeting primary sclerosing cholangitis, which represents a significant market opportunity [14] Q&A Session Summary Question: What is the status of prior authorizations relative to the total addressable market for the product? - Management reported over 80% approval rates for prior authorizations, with some regions achieving even higher rates [29][30] Question: What will the working capital benefits from the transfer to DSC look like on the balance sheet? - The company expects to ramp down inventory production as DSC takes over, with inventory decreasing in the second half of the year [31][32] Question: What drove the significant growth from April to May? - The growth was attributed to the strategy targeting statin intolerant patients and increased awareness through marketing campaigns [36][37] Question: How does the company view consensus U.S. revenue for the year? - Management indicated they are tracking well ahead of consensus and expect to achieve milestone payments in the second half of the year [44][45] Question: What is the outlook for gross margin trends in the back half of the year? - Management expects benefits from the tech transfer to kick in early next year, with steady favorable gross to net ratios anticipated [51][55] Question: How will Nexletol remain competitive in the non-statin LDL space? - The company highlighted its unique position as the only product studied in statin intolerant patients and its strong patent position [60][62]

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]

Core Insights - Esperion reported Q1 2025 total revenue of $65.0 million, a decrease of 53% year-over-year, but adjusted for a one-time milestone in Q1 2024, total revenue grew 63% year-over-year [1][15] - U.S. net product revenue increased by 41% year-over-year to $34.9 million [1][15] - Bempedoic acid received Level 1a recommendations in the 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines for managing patients with Acute Coronary Syndromes [1][10] - The company expanded its development portfolio with a new program targeting Primary Sclerosing Cholangitis (PSC), a market estimated to exceed $1 billion [1][3] Financial Performance - Total revenue for Q1 2025 was $65.0 million, down from $137.7 million in Q1 2024, primarily due to a settlement agreement milestone received in the previous year [15][33] - U.S. net product revenue rose to $34.9 million from $24.8 million in the same period last year, marking a 41% increase [15][33] - Collaboration revenue fell to $30.1 million from $113.0 million year-over-year, a decrease of 73%, but grew 97% when excluding the milestone [15][33] - The company reported a net loss of $40.5 million compared to a net income of $61.0 million in Q1 2024 [13][33] Commercial Strategy - The company surpassed one million prescriptions for bempedoic acid products in the U.S. [3][6] - Esperion expanded its reimbursement team from five to 15 specialists to enhance support for healthcare providers and patients [6] - New marketing initiatives targeting statin-intolerant patients, who represent 30% of the lipid-lowering market, are expected to drive prescription growth [6][3] - The company is advancing two triple combination products for commercialization in 2027, which could provide LDL-C lowering in excess of 60% [6][3] Research and Development - Esperion hosted an R&D Day highlighting its capabilities and promising research for PSC treatment candidates [10][7] - Pre-clinical data showed that the company's allosteric ACLY inhibitor could reduce liver injury markers in PSC models [10][7] - The estimated prevalence of diagnosed PSC patients in the U.S. and Europe is approximately 76,000 as of 2024 [10][7] Market Positioning - Esperion's European partner, Daiichi Sankyo Europe, reported an 8% sequential increase in royalty revenue to $10.5 million, indicating strong market penetration for its products [10][6] - The company is on track for expected approval and pricing in Japan in the second half of 2025 [6][10]

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]