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]

Financial Data and Key Metrics Changes - The company reported growth in Q2, overcoming headwinds faced in Q1, particularly related to Medicare and overall market conditions [4] - Prescription growth began to exceed expectations around mid-March, with co-pay issues for Medicare patients significantly reduced [5] Business Line Data and Key Metrics Changes - The lead products, NEXLETOL and NEXLASET, have seen increased traction, particularly in the statin intolerant population, which has been positively received by physicians [6][12] - The sales force has effectively communicated the benefits of the products, leading to a doubling or tripling of new prescribers since the statin intolerance campaign [12] Market Data and Key Metrics Changes - In Europe, the company has experienced consistent growth, with Daiichi Sankyo reporting 20-30% growth each quarter since launch [15] - The company is catching up with Daiichi in Europe, indicating a strong competitive position [15] Company Strategy and Development Direction - The company plans to develop a triple combination therapy in the U.S., which includes bempedoic acid, ezetimibe, and two commonly prescribed statins [17][18] - The company is also pursuing international agreements, with Otsuka Pharmaceuticals commercializing the product in Japan and other agreements in Canada, Australia, and Israel [21][22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching profitability soon, with a growth trajectory that supports self-funding for future projects [42][43] - The company is excited about the potential of a new compound targeting primary sclerosing cholangitis (PSC), which represents a significant market opportunity [37][38] Other Important Information - The company has a strong patent portfolio, with potential extensions beyond 2031, which could reshape the company's financial outlook [28][30] - The recent settlement with MicroLabs regarding generic Nexletol is confidential, but management believes it sets a precedent for future negotiations with other ANDA filers [26][29] Q&A Session Summary Question: How are revenues tracking for NEXLETOL and NEXLASET? - Management noted that Q2 is off to a great start, with prescription growth exceeding expectations since mid-March [4][5] Question: What is the current target population for NEXLETOL and NEXLASET? - The focus is on the statin intolerant population, which has been well received by physicians [6] Question: Can you comment on the expansion of the drug in Europe? - Daiichi Sankyo has shown consistent growth in Europe, and the company expects to surpass them eventually [15] Question: What are the plans for a triple combination therapy? - The company is developing a triple combination therapy that could significantly improve patient adherence and outcomes [17][18] Question: What is the timeline for the PSC drug development? - The PSC drug is currently in preclinical stages, with expectations to launch in the early 2030s [41] Question: How does the company view its path to profitability? - Management is optimistic about reaching profitability soon, with a solid growth trajectory and cash position [42][43]

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]

Core Insights - Esperion is participating in the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, at 10 a.m. ET [1] - The company is focused on developing and commercializing FDA-approved oral, once-daily, non-statin medications for patients at risk for cardiovascular disease [2] - Esperion is advancing its next-generation program targeting ATP citrate lyase inhibitors (ACLYi) to create highly potent and specific inhibitors [2][3] Company Overview - Esperion Therapeutics is a commercial-stage biopharmaceutical company addressing unmet medical needs in cardiovascular health [2] - The company has conducted the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients to support its medications [2] - Esperion is evolving into a leading global biopharmaceutical company through commercial execution and international partnerships [3]

Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Event**: 2025 Conference - **Date**: May 08, 2025 Key Points Industry and Product Insights - **Study Results**: The CLEAR Outcomes study involved 14,000 patients and demonstrated a nearly 40% reduction in major adverse cardiovascular events (MACE) in primary prevention settings, which is significant for patients who have not yet experienced cardiovascular events [1][2] - **Market Opportunity**: The drug provides an alternative for patients who cannot tolerate statins, with up to 30% of the population unable to achieve their cardiovascular health goals with statins alone [2] - **Patient Population**: The new label allows access to approximately 70 million patients in the U.S., significantly expanding the potential market [9] Launch and Sales Strategy - **Initial Launch Challenges**: The drug was launched in March 2020, coinciding with the COVID-19 pandemic, which complicated initial sales efforts [4] - **Sales Force Restructuring**: The company reduced its sales force from 300 to 70 representatives in October 2021, focusing on consistent quarterly growth and achieving positive outcomes from the CLEAR Outcomes trial [6][8] - **Reimbursement Improvements**: Post-label update, reimbursement access improved significantly, with many major payers eliminating prior authorization requirements, facilitating easier access for patients [10][11] Physician and Patient Feedback - **Physician Reception**: Physicians have responded positively to the drug, appreciating the compelling outcomes data and the drug's tolerability [12][15] - **Awareness Campaigns**: The company is focusing on increasing awareness among physicians and patients through targeted digital marketing strategies [19][20] Market Dynamics - **Market Share**: The drug is primarily being used in the primary prevention setting, with a significant portion of the 70 million patient market being targeted [22] - **Growth Trends**: The company experienced double-digit growth in prescriptions, although the first quarter of the year saw some slowdown due to changes in Medicare [23][24] Financial and Operational Updates - **Debt Management**: The company successfully restructured its debt, reducing $700 million in debt and deferring $265 million in convertible notes to 2030, improving its capital structure [50][51] - **Cash Position**: As of Q1, the company had approximately $114 million in cash, with expectations for improved cash flow as the year progresses [59] Future Developments - **New Drug Development**: The company is pursuing a triple combination therapy involving bempedoic acid, ezetimibe, and statins, aiming for significant LDL-C reduction [37][38] - **Expansion Plans**: Esperion is also exploring opportunities in other markets, including Japan and Canada, with partnerships established for launches in these regions [62] Competitive Landscape - **Loss of Exclusivity**: The company is aware of nine ANDA filers for generics but believes it has solid intellectual property protection until mid-2031, with additional patents extending to 2040 [34][36] Research and Development - **New Indications**: The company is exploring treatments for familial hypocholesterolemia and primary sclerosing cholangitis, indicating a commitment to expanding its therapeutic portfolio [42][48] Conclusion Esperion Therapeutics is positioned to capitalize on its recent label updates and improved reimbursement access, targeting a significant market of patients who cannot tolerate statins. The company is focused on growth through strategic marketing, debt management, and new product development, while navigating the competitive landscape of cardiovascular therapies.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35986 Esperion Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or ...

Core Insights - Esperion Therapeutics has entered into a license and distribution agreement with HLS Therapeutics for the exclusive rights to commercialize NEXLETOL and NEXLIZET in Canada, which will enhance access to these cardiovascular therapies for 2.6 million Canadians living with diagnosed heart disease [1][4][2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing non-statin medications for patients at risk for cardiovascular disease, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [7][8] - HLS Therapeutics, established in 2015, specializes in the acquisition and commercialization of late-stage and established pharmaceutical products, particularly in the areas of psychiatric disorders and cardiovascular disease [6] Financial Terms of the Agreement - Under the agreement, Esperion will receive an upfront payment, milestone payments of up to approximately $5 million, and tiered royalties on product sales [5][4] - Esperion will supply finished products to HLS Therapeutics at a profitable transfer price, while HLS will handle commercialization, including reimbursement and marketing [4][5]

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]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 grew 63% year over year to $65 million after adjusting for a one-time milestone received in Q1 2024 [9][19] - U.S. net product revenue increased 41% year over year to $34.9 million, driven by expanded label and commercial initiatives [9][20] - Collaboration revenue decreased approximately 73% to $30.1 million due to the settlement agreement milestone, but grew 97% excluding that milestone [20][22] Business Line Data and Key Metrics Changes - U.S. product sales growth was impacted by seasonal headwinds and changes in Medicare Part D, but early Q2 trends show prescription volume tracking approximately 8% higher than Q1 [9][21] - The company expanded its field reimbursement support team threefold to enhance access for prescribers [9][10] - The inclusion of NEXLETOL and NEXLASET in the 2025 ACCAHA guidelines is expected to improve market access and prescribing behavior [10][11] Market Data and Key Metrics Changes - Royalty revenue from Daiichi Sankyo Europe increased 8% from Q4 2024 to $10.5 million in Q1 2025, with approximately 472,500 patients treated in Europe [14][15] - The Japanese market is anticipated to be a significant revenue contributor, with approval expected in the second half of 2025 [16] Company Strategy and Development Direction - The company is focused on revenue growth, portfolio expansion, and pipeline advancement, particularly in cardiovascular health [6][7] - Plans to commercialize a triple combination product by 2027, which aims to provide a compelling option for LDL cholesterol management [13][17] - The company is expanding its global reach through partnerships and regulatory submissions in various international markets [16][17] Management Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by seasonal market dynamics and changes in Medicare, but expressed optimism about a return to growth [21][62] - The company is committed to navigating complexities in the healthcare landscape to ensure patient access to its products [21][22] - Management emphasized the importance of innovation and collaboration in driving future growth and improving cardiovascular health [24] Other Important Information - The company reiterated its full-year 2025 operating expense guidance of approximately $215 million to $235 million [23] - Cash and cash equivalents stood at $114.6 million as of March 31, 2025, indicating a strong financial position [23] Q&A Session Summary Question: When should we expect a new business development deal? - Management is making progress but will not set a timeline for a new deal, as they want to ensure it aligns with the company's strategy [30][31] Question: Is the triple combination product a defensive strategy? - The triple combination product is seen as a convenient option for patients, potentially offering the most efficacious LDL lowering treatment on the market [32][33] Question: Is the current sales force right-sized? - The current sales force of approximately 155 representatives is deemed appropriate, with a focus on balancing personal and digital promotion [39] Question: What are the dynamics affecting NEXLETOL and NEXLIZET sales? - Seasonal factors and confusion around Medicare impacted sales, but early signs of improvement are noted as patient co-pays decrease [62][63] Question: What is the timeline for the triple combination product? - The product is expected to reach the market in 2027, with no clinical study required for regulatory approval [67] Question: What is the outlook for gross margin? - Gross margin is expected to improve as the tech transfer progresses, with adjustments in cost of goods sold anticipated to stabilize [70][71]

Esperion Therapeutics (ESPR) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to earnings of $0.34 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -16.67%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.14 per share when it actually produced a loss of $0.10, delivering a surprise of 28.57%.Over the last four quart ...