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]

Business Overview - U.S net product revenue of NEXLETOL® and NEXLIZET® grew by 12% from Q3 2021 to $12.2 million in Q4 2021[10] - Sequential prescription growth of 9% from Q3 2021 with over 70,000 cumulative patients[10] - CLEAR Outcomes trial reached 90% MACE Accumulation in February 2022, with topline results expected in Q1 2023[10, 16] Financial Update - Ended Q4 2021 with $309.3 million in cash, cash equivalents, restricted cash and investment securities[10] - FY 2021 Operating Expenses were $305 million[22] - FY 2022 R&D Guidance is $100 - $110 million[22] - FY 2022 SG&A Guidance is $120 - $130 million[22] - Future Ex-U.S Collaboration Milestones from Daiichi Sankyo & Otsuka are >$1.2 billion[22] - Q4 2021 Common Shares Outstanding were 60.9 million[22]

Business Highlights - Approximately 35 million patients are considered statin intolerant in the U S, Japan, and the EU[8] - Statin intolerance impacts up to 20% of individuals treated with a statin[8, 12] - CLEAR Outcomes trial has enrolled over 14,000 patients and is powered for success[12] - The CLEAR Outcomes trial expects a high baseline LDL-C of approximately 140 mg/dL[12] Operational Performance - Over 8,600 doctors are writing at least one prescription for Esperion's medicines[15] - More than 3,300 patients are taking Esperion's medicines every week[15] - Over 420,000 seven-day starter packs have been requested and received[15] - New-to-brand statin prescriptions are down 9% year-to-date 2021 compared to year-to-date 2020 due to COVID-19 impacts[17] Financial Results & Guidance - U S Net Product Sales increased 14 6% quarter over quarter[23] - Royalty revenues from DSE were $8 2 million in the quarter[23] - Ex-U S Collaboration Milestones were $3 3 million[23] - The company anticipates FY 2021 revenues between $120 - $130 million[26]

Financial Performance - U S net product revenue of NEXLETOL® and NEXLIZET® grew approximately 109% year-over-year to $134 million in Q1 2022[9, 27] - Royalty and Partner revenue increased approximately 244% year-over-year to $55 million in Q1 2022[9] - Q1 2022 Operational Expenses decreased 32% year-over-year[9] - The company ended Q1 2022 with $2685 million in cash, cash equivalents, restricted cash, and investment securities[9] Prescription Growth - Quarterly Retail Prescription Equivalents (RPE) grew +567% year-over-year and +65% quarter-over-quarter[9] Clinical Trial Progress - The CLEAR Outcomes trial is approaching 95% MACE accumulation, with 100% MACE expected by year-end and topline results anticipated in Q1 2023[9, 20] - The CLEAR Outcomes trial is a 14,014-patient randomized, double-blind, placebo-controlled clinical trial with a median follow-up anticipated to be 375 years[20] Market Opportunity - The company is progressing its pipeline, including an oral PCSK9 inhibitor and an ACL inhibitor platform, which will participate in a market valued at over $11 billion in 2026[19] Financial Outlook - FY 2022 Research and Development (R&D) guidance is $100 - $110 million[27] - FY 2022 Selling, General & Administrative (SG&A) guidance is $120 - $130 million[27] - FY 2022 Operating Expense (Op Ex) guidance is $220 - $240 million[27]

Company Overview & Strategy - Esperion is evolving into a global cardiometabolic biotech, advancing the CLEAR Outcomes trial and pre-clinical pipeline assets [6] - The company restructured and financed in 2021 to reduce cost burn and strengthen the cash balance [9] - Esperion launched two approved drugs in Q2 2020 in the U S, with strong IP protection anticipated until mid-2031 [9] Market & Products - Nearly 80% of very high-risk patients in the U S did not meet guideline-recommended LDL-C goals [18] - 8.7 million patients in the U S don't reach their LDL-C goals despite taking a statin, while 9.6 million with high LDL-C are not on statins [18] - Up to 20% of people who could be treated with a statin experience statin intolerance [18] - NEXLETOL & NEXLIZET are safe & well-tolerated oral options for LDL-C lowering [30] Financial Performance & Outlook - Q1 2022 U S revenue was $13.4 million [35] - Esperion has >$1.2 billion in potential future ex-U S collaboration milestones from Daiichi Sankyo & Otsuka [67] - Esperion's Q1 2022 cash, cash equivalents, restricted cash & investment securities available-for-sale totaled $268.5 million [67] Clinical Development - The CLEAR Outcomes trial is approaching 100% MACE accumulation in 2H 2022, with top-line results anticipated in Q1 2023 [43] - Over 14,000 patients in 32 countries are fully enrolled in the CLEAR Outcomes trial [44]

Core Insights - Esperion has appointed Craig Thompson, CEO of Cerevance, as an independent director on its Board of Directors, expanding the board to eight members [1][2]. Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing innovative medicines for cardiovascular disease, specifically targeting patients with elevated low-density lipoprotein cholesterol (LDL-C) [7]. - The company has developed the only FDA-approved oral, once-daily, non-statin medications for at-risk cardiovascular patients, supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial [7]. Leadership Experience - Craig Thompson brings over 20 years of biopharmaceutical leadership experience, with a strong background in pharmaceutical commercialization and clinical development, which aligns with Esperion's mission [2][3]. - Prior to joining Esperion, Mr. Thompson held leadership roles at various biotechnology companies, including Cerevance, Neurana Pharmaceuticals, and Anthera Pharmaceuticals, and has experience in global marketing at Pfizer and Merck [4][5][6]. Strategic Focus - The appointment of Mr. Thompson is expected to enhance Esperion's strategic insight and operational expertise as the company aims to expand its impact in cardiovascular and cardiometabolic drug development [2][3]. - Esperion is advancing its pre-clinical pipeline and focusing on developing ATP citrate lyase inhibitors (ACLYi), which are expected to enable rational drug design and the development of highly potent inhibitors [7][8].

Group 1 - Esperion Therapeutics, Inc (NASDAQ: ESPR) has experienced a 64% rebound from its all-time low, indicating positive market response amidst recent biotech and healthcare conferences [1] - The company has been actively participating in various industry conferences, which may have contributed to the stock's recovery [1] Group 2 - The article highlights the author's extensive background in financial markets, including experiences during significant market events, which may provide valuable insights into investment strategies [1] - The author emphasizes the importance of both technical and fundamental analysis in trading and investing, suggesting a comprehensive approach to market evaluation [1]

Summary of Esperion Therapeutics Conference Call Company Overview - Esperion Therapeutics has been operational since 2008, gaining prominence with the launch of Nexlitol and Nexlazet in 2020 [5][6] - The company is focused on both commercializing drugs and developing a robust pipeline, including a new asset for primary sclerosing cholangitis (PSC) [6][7] Commercial Performance - Esperion is the only non-statin drug with primary prevention capabilities, which has resonated well with primary care physicians and cardiologists [9][10] - The company reported growth in a flat market, with positive trends continuing into the second quarter [10][12] - Adoption of Nexlitol and Nexlazet has increased, particularly among physicians who previously did not prescribe these drugs, attributed to the statin intolerance message [12][13] Market Dynamics - The total addressable market (TAM) for Nexlitol and Nexlazet increased from 10 million to 70 million patients post-clear outcome study [17] - Medicare plans have shown a 72% adoption rate, with some eliminating prior authorization requirements, facilitating easier access for patients [18][19] - The recent redesign of Medicare Part D has resulted in lower out-of-pocket costs for patients, enhancing drug accessibility [20][22] Sales Force Expansion - Esperion expanded its sales force by 72 individuals, totaling 155 sales representatives, and increased field reimbursement managers from 6 to 15 [25][26] - The expansion has already shown qualitative improvements in approval rates for drug prescriptions, moving from the low seventies to the high seventies and low eighties [28][30] Competitive Landscape - The company is aware of emerging competitors in the lipid-lowering market, including Novartis and other clinical-stage assets [35][36] - Esperion's unique positioning in primary prevention and the ability to use its drugs with or without statins is emphasized as a competitive advantage [43] International Opportunities - Esperion's partner Otsuka is expected to launch the drug in Japan by Q4 2023, with a significant market opportunity due to a large population unable to take statins [45][46] - The company anticipates profitability by January 2026, driven by international market expansion [47] Research and Development - Esperion is pursuing PSC as a new indication, leveraging ACLY biology to address liver disease [55][56] - The company aims to expedite the clinical timeline for PSC, with potential market entry before the early 2030s [68] Future Pipeline and Strategy - Esperion is considering a fixed-dose combination of statin and ezetimibe for the U.S. market, which would require only a bioequivalence study [70][71] - The company is exploring business development opportunities to leverage its existing infrastructure for marketing and selling other drugs [84][88] Intellectual Property - Esperion is currently involved in litigation with generic filers, with two settlements reached, and is planning for patent expiry in June 2031 [52][53] Conclusion - Esperion Therapeutics is positioned for growth with a strong commercial strategy, expanding sales force, and promising pipeline developments, particularly in the lipid-lowering and liver disease markets [51][88]

Company Overview - Esperion Therapeutics (ESPR) shares have increased by approximately 28.6% over the past month, outperforming the S&P 500 [1] - The most recent earnings report is crucial for understanding the stock's performance and potential catalysts [1] Earnings Estimates - Estimates for Esperion Therapeutics have trended downward, with the consensus estimate decreasing by 25.93% over the past month [2] - The overall direction of estimate revisions indicates a downward shift in expectations for the company [4] VGM Scores - Esperion Therapeutics has a Growth Score of B, a Momentum Score of F, and a Value Score of C, placing it in the middle 20% for the value investment strategy [3] - The aggregate VGM Score for the stock is D, which is relevant for investors not focused on a single strategy [3] Industry Performance - Esperion Therapeutics is part of the Zacks Medical - Drugs industry, which includes Ionis Pharmaceuticals (IONS) [5] - Ionis Pharmaceuticals has seen a 6.2% gain over the past month, with reported revenues of $132 million, reflecting a year-over-year increase of 10.9% [5] - Ionis Pharmaceuticals is expected to report a loss of $0.14 per share for the current quarter, showing a year-over-year improvement of 68.9% [6]

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.