– Bempedoic Acid Highlighted by ACC for LDL-C Lowering in Patients with Peripheral Artery Disease and Diabetes Based on Proven Cardiovascular and Limb Benefits – ANN ARBOR, Mich., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) welcomed the inclusion of bempedoic acid as a first-line, evidence-based therapy for LDL-C lowering for patients on maximally tolerated statins in the 2025 American College of Cardiology (ACC) Scientific Statement on Management of Peripheral Artery Disease (PAD) in Adults w ...

Summary of Esperion Therapeutics FY Conference Call Company Overview - **Company**: Esperion Therapeutics (NasdaqGM:ESPR) - **Focus**: Bempedoic acid, a treatment for statin intolerance and lipid lowering Key Industry Insights - **Market Potential**: The total addressable market (TAM) for bempedoic acid increased from 10 million to 70 million patients following the label expansion in April 2024 [3][6] - **Guideline Inclusion**: Bempedoic acid received a Class 1A recommendation in European clinical practice guidelines, emphasizing its role in treating statin intolerant patients [5][6] - **Sales Growth**: The company is experiencing strong sales growth and momentum, particularly in the third and fourth quarters of 2025 [4][6] Core Points and Arguments - **Clinical Data Impact**: The CLEAR Outcomes study significantly improved the company's capital structure and market position, allowing for effective promotion of bempedoic acid [3][4] - **Guideline Influence**: The upcoming U.S. guidelines are expected to align closely with European guidelines, which could provide substantial tailwinds for sales [7][9] - **Commercial Strategy**: Esperion is focusing on both personal promotion and digital outreach, currently calling on 20,000 physicians in person and 60,000 digitally, with plans to expand to 80,000 by 2026 [18][20] Competitive Positioning - **Comparison with Other Treatments**: Bempedoic acid is positioned as a complementary treatment to ezetimibe and PCSK9 inhibitors, with a unique advantage in primary prevention and hs-CRP lowering [12][14] - **Patient Preference**: Surveys indicate that patients prefer oral medications over injectables, which may enhance bempedoic acid's market appeal [14][20] Financial and Market Access - **Payer Coverage**: Esperion has achieved 90% commercial coverage and 85% Medicare coverage, with favorable positioning in formularies [24][25] - **Pricing Strategy**: The company maintains a competitive pricing model, with cash prices lower than competitors, which is crucial for patient access [26][27] International Expansion - **European Market Performance**: Over 600,000 patients are currently using bempedoic acid in Europe, with strong growth driven by favorable guidelines [32][33] - **Japan Launch**: The company is optimistic about the launch in Japan, supported by a dedicated team and a $90 million milestone payment [34][35] Future Outlook - **Triple Combination Therapy**: Esperion is developing a triple combination therapy that could become the most effective LDL-lowering pill on the market, expected to launch by the end of 2027 [44][47] - **Next-Generation Products**: The company is advancing its next-generation ACLY inhibitor, with human studies anticipated to begin by late 2026 [49] Additional Considerations - **Litigation Settlements**: Recent settlements with generic filers have extended the exclusivity runway for bempedoic acid, with confidence in maintaining market position into the 2030s [41][42] - **Market Dynamics**: The competitive landscape includes other oral treatments, but Esperion believes its established clinical data and guideline support will provide a significant advantage [36][39]

Summary of Esperion Therapeutics Conference Call Company Overview - **Company**: Esperion Therapeutics (NasdaqGM:ESPR) - **Focus**: Development and commercialization of bempedoic acid, a cardiovascular drug Key Points Industry and Market Dynamics - **Market Expansion**: The addressable market for bempedoic acid increased from approximately 10 million patients to 70 million following the updated cardiovascular outcomes trial label in April 2024 [3][4] - **Growth Metrics**: Esperion has demonstrated double-digit growth quarter over quarter since the label update [3][4] - **Payer Landscape**: Major payers have improved reimbursement conditions, transitioning the drug from a niche product to a broadly labeled cardiovascular drug [3][4] Financial Performance and Strategy - **Debt Management**: Esperion has successfully reduced its debt, ending the year with less debt than it started [4][5] - **Profitability Goals**: The company aims to achieve sustainable profitability in Q1 2026, with expectations of generating substantial cash flow [26][45] Product and Pipeline Developments - **Guidelines Update**: Anticipated updates to U.S. guidelines in early 2026 are expected to align closely with European guidelines, which have already provided a strong recommendation for bempedoic acid [9][10] - **Market Access**: The company has improved market access, with high approval rates for prior authorizations, indicating strong positioning for bempedoic acid [14][15] - **Sales Strategy**: The sales force currently consists of 155 representatives, with plans to expand to capitalize on upcoming guidelines and market opportunities [19][25] Competitive Landscape - **Market Positioning**: Esperion believes it is well-positioned against competitors, with a strong outcomes trial and favorable payer access [29][30] - **Emerging Therapies**: The company is monitoring new oral therapies but does not feel significantly threatened by them due to its established market presence and outcomes data [30][31] Future Opportunities - **Expansion into Rare Diseases**: Esperion is exploring opportunities in rare diseases, with a focus on developing new compounds beyond lipid-lowering therapies [36][42] - **Cash Position**: The company reported a pro forma cash position of approximately $170 million, indicating strong financial health to support its initiatives [45] Conclusion - Esperion Therapeutics is on a growth trajectory with significant market potential for bempedoic acid, a solid financial foundation, and a strategic focus on expanding its product pipeline into rare diseases while maintaining its core cardiovascular offerings. The upcoming guidelines and market access improvements are expected to drive further growth and profitability.

Summary of Esperion Therapeutics Conference Call Company Overview - **Company**: Esperion Therapeutics (NasdaqGM:ESPR) - **Event**: Key opinion leader-investor event focused on statin intolerance and cardiovascular health - **Date**: November 11, 2025 Key Points Financial Performance - **Q3 Total Revenue**: $87.3 million, representing a nearly 70% year-on-year growth [3] - **Q3 US Net Product Sales**: $40.7 million, indicating a 31% year-on-year growth [3] - **Retail Prescription Equivalents**: 9% increase quarter-over-quarter [4] Product Development and Market Position - **Nexletol and Nexlizet**: Outpacing the broader lipid-lowering market and exceeding growth of other non-statin therapies [4] - **Statin Intolerance**: Approximately 50% of patients starting statin therapy discontinue or have significant gaps in treatment within two years, highlighting a market opportunity for Nexletol and Nexlizet [5] - **Direct-to-Consumer Advertising**: Launched on platforms like Disney+ and Hulu, achieving over 6 million impressions since October [7] Clinical Insights - **Statin Intolerance Definition**: Up to 30% of US adults experience some degree of statin intolerance, which can lead to non-adherence and increased cardiovascular risk [10][12] - **Bempedoic Acid**: Developed to address statin intolerance, it is a pro-drug that targets the liver, avoiding muscle-related side effects associated with statins [15] - **Clinical Trials**: Bempedoic acid has shown significant LDL cholesterol reduction and hsCRP lowering, with the Clear Outcomes trial being the only outcomes study in statin-intolerant patients [19][22] Market Access and Awareness - **Medicare and Commercial Approval Rates**: 87% for Medicare and 86% for commercial plans, indicating improved access for patients [8] - **Patient Copays**: Average copays are $29 and $36 for a 30-day supply, reflecting growing payer confidence [8] - **Awareness Challenges**: There is a significant gap in awareness among healthcare professionals regarding non-statin therapies, which affects adoption rates [52][56] Physician Perspectives - **Patient Characteristics**: Females and older individuals are at higher risk for statin intolerance, and many patients are unwilling to start statin therapy due to perceived side effects [12][14] - **Combination Therapy**: There is a growing trend towards using combination therapies to achieve LDL targets, especially in high-risk patients [40][41] - **Imaging Tools**: Physicians are increasingly using imaging to educate patients about their cardiovascular risk and the importance of LDL-lowering therapies [48] Future Outlook - **Guideline Updates**: Recent ESC guidelines emphasize the importance of non-statin therapies, with bempedoic acid receiving high recommendations for statin-intolerant patients [22] - **Educational Commitment**: Esperion is dedicated to educating both healthcare providers and patients about statin intolerance and available alternatives [23] Additional Insights - **Patient Education**: There is a need for better education regarding the risks of high LDL cholesterol and the importance of treatment adherence [56] - **Market Potential**: The potential market for bempedoic acid is significant, especially among primary care populations and patients with diabetes [58] This summary encapsulates the key insights and data presented during the conference call, highlighting Esperion Therapeutics' performance, product positioning, and the broader implications for cardiovascular health management.

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 grew 69% year over year to $87.3 million [4][18] - U.S. net product revenue increased 31% year over year to $40.7 million [4][18] - Collaboration revenue rose approximately 128% to $46.7 million compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - U.S. prescription growth saw nearly double-digit sequential growth, contributing to the overall revenue increase [4] - Average approval rate for Medicare coverage reached 87%, with out-of-pocket costs reduced significantly [10][11] - Total retail prescription equivalents increased by 9% from Q2 2025, with a 7% increase in the number of healthcare professionals prescribing Nexletol and Nexlizet [12] Market Data and Key Metrics Changes - The company outpaced the broader adjunct lipid-lowering market, achieving growth that exceeded all other non-statin products [6] - Royalty revenue from Daiichi Sankyo Europe increased 21% sequentially to $16.4 million [14] Company Strategy and Development Direction - The company is focused on expanding patient access programs and enhancing marketing strategies to drive future growth [4][5] - Strategic agreements with four generic manufacturers were finalized to protect the long-term value of its products [5] - The inclusion of bempedoic acid in ESC/EAS guidelines is expected to support expanded utilization and reinforce the company's market position [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustainable profitability by Q1 2026, despite one-time costs impacting net income [24] - The company anticipates continued growth momentum driven by strong execution and strategic investments [21][31] Other Important Information - The company closed a $75 million follow-on equity offering to ensure adequate capital for future developments [20] - The launch of Nexletol in Japan is expected to occur shortly after final pricing approval, which is anticipated within weeks [31][15] Q&A Session Summary Question: What were the drivers behind the gross margins for this quarter? - Gross margin drivers included low-margin tablet sales to partners, with expectations for improvement in 2026 as manufacturing is transferred [22] Question: Can you comment on achieving sustainable profitability in Q1 of 2026? - Management confirmed tracking in line with forecasts for sustainable ongoing profitability, with many Q3 expenses being one-time or non-recurring [24] Question: Regarding reimbursement per script, why were U.S. revenues flat despite a 9% increase in scripts? - One-time investments were made to secure preferred access with Medicare plans, impacting short-term revenue but expected to benefit future growth [25][27] Question: What feedback has been received regarding the ESC/EAS guidelines? - Positive feedback from partners indicates excitement among physicians regarding the guidelines, which are expected to enhance market reception [30] Question: What is the status of the 340B utilization of Nexletol and Nexlizet? - 340B utilization is minimal and not expected to impact revenue outlook [33] Question: What is the plan for the PSC pipeline and IND filing? - The company is in the planning phase for the PSC pipeline and aims to move quickly due to the high unmet need [34]

Financial Performance - Total revenue for Q3 2025 reached $87.3 million, a 69% year-over-year increase[7, 31] - U S net product sales for Q3 2025 were $40.7 million, representing a 31% year-over-year growth[7, 31] - Collaboration revenue increased by 128% year-over-year, reaching $46.7 million in Q3 2025[31] - Esperion closed a $75 million follow-on equity offering, resulting in net proceeds of approximately $72.6 million[31] Market Access and Expansion - Retail prescription equivalents increased by 9% quarter-over-quarter[8, 39] - The total prescriber base now exceeds 30,000 healthcare professionals[10] - Medicare coverage reached 87% and commercial coverage reached 86%[13] Guideline Recognition and Strategic Partnerships - Bempedoic acid received a Level 1a recommendation in the updated ESC/EAS Guidelines for Management of Dyslipidemia[8, 15] - Esperion has partnerships in over 40 countries globally, including Europe, Japan, Asia, South America, Israel, Australia & New Zealand, and Canada[19] Pipeline and Future Outlook - Triple Combination A and B are projected to have NDA filings in 2027[25] - The company expects market approval in Canada in Q4 2025[19]

Core Insights - Esperion reported a total revenue growth of 69% year-over-year to $87.3 million for Q3 2025, driven by increased U.S. prescription volume and expanded payer coverage [1][12] - The company achieved a U.S. net product revenue increase of 31% year-over-year to $40.7 million in Q3 2025 [1][12] - Esperion's partner, Otsuka, received regulatory approval and favorable preliminary pricing for NEXLETOL in Japan, which will trigger significant milestone payments upon final pricing approval [1][11] Financial Performance - Total revenue for the three and nine months ended September 30, 2025, was $87.3 million and $234.7 million, respectively, compared to $51.6 million and $263.2 million for the same periods in 2024, marking a 69% increase and an 11% decrease, respectively [12][15] - U.S. net product revenue for the three and nine months ended September 30, 2025, was $40.7 million and $115.8 million, respectively, compared to $31.1 million and $84.2 million for the same periods in 2024, reflecting a 31% and 38% increase [12][15] - Collaboration revenue was $46.7 million and $118.8 million for the three and nine months ended September 30, 2025, respectively, compared to $20.5 million and $179.0 million for the same periods in 2024, indicating a 128% increase and a 34% decrease, respectively [12][15] Strategic Developments - The inclusion of bempedoic acid as a Class I, Level A recommendation in the 2025 ESC/EAS guidelines is expected to enhance its market position and utilization [3][5] - Esperion reached a settlement agreement with ANDA filer Dr. Reddy's Laboratories, preventing the marketing of generic versions of NEXLETOL and NEXLIZET until April 2040 [5][6] - The company has strengthened its branding and marketing efforts, particularly targeting the statin intolerant population, which has contributed to increased healthcare practitioner engagement [2][6] Research and Development - Esperion is advancing its R&D pipeline, including the nomination of ESP-2001 for the treatment of primary sclerosing cholangitis, which represents a potential market opportunity exceeding $1 billion annually [11][31] - The company is also focused on enhancing patient access through various support programs and market access initiatives in anticipation of updated U.S. guidelines for dyslipidemia management [7][11] Market Expansion - Esperion's strategic partner in Europe, Daiichi Sankyo Europe, continues to show robust revenue growth for NILEMDO and NUSTENDI, with a 21% sequential increase in royalty revenue to $16.4 million [11] - The company is on track for market approvals in Canada and Israel for NEXLETOL and NEXLIZET by the end of 2025 and the first half of 2026, respectively [11][12]

Core Insights - Esperion Therapeutics (ESPR) is conducting a secondary offering of 30 million shares at $2.50 per share, aiming to raise approximately $75 million in gross proceeds [1][7] - The stock price fell nearly 17% following the announcement due to the discounted pricing, which was 19% below the previous closing price of $3.09 [2][7] - The proceeds from the offering will be used to expand the commercial reach of marketed drugs Nexletol and Nexlizet, support clinical development, and for general corporate purposes [4][7] Financial Details - The secondary offering is expected to close today, with net proceeds estimated at $70.2 million after expenses [1] - The underwriters have an option to purchase an additional 4.5 million shares at the same price [1] Product Information - Nexletol and Nexlizet are marketed for treating elevated LDL-C and cardiovascular risk reduction, with Nexlizet being a combination of bempedoic acid and ezetimibe [5] - The company has settled patent litigation with Dr. Reddy's Laboratories, preventing the launch of generic versions of its drugs until April 19, 2040 [6] Legal Context - Esperion has signed similar agreements with other generic drugmakers, ensuring that they cannot market generics of Nexletol or Nexlizet until 2040 [8] - Ongoing patent litigation remains with other generic challengers, including Sandoz, Aurobindo Pharma, and MSN Pharmaceuticals [8] Market Performance - Year-to-date, ESPR's stock has gained 17%, outperforming the industry average growth of 10% [2]

Core Insights - Esperion has entered into a settlement agreement with Dr. Reddy's Laboratories, resolving patent litigation regarding generic versions of NEXLETOL and NEXLIZET, preventing Dr. Reddy's from marketing these generics in the U.S. before April 19, 2040, unless specific circumstances arise [1] - The settlement with Dr. Reddy's follows previous agreements with Micro Labs USA, Hetero USA, and Accord Healthcare concerning their generic versions of NEXLETOL, ensuring no remaining challenges to the validity of U.S. Patent No. 7,335,799, which expires in December 2030 [2] - Ongoing patent litigation against other defendants remains, with uncertainty regarding the potential for generic versions of NEXLETOL and NEXLIZET to be marketed before the April 2040 date [3] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral medications for patients at risk for cardiovascular disease, specifically targeting elevated low-density lipoprotein cholesterol (LDL-C) [4] - The company is advancing its pre-clinical pipeline and aims to establish itself as a leading global biopharmaceutical entity through commercial execution and international partnerships [5]

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]