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.

Financial Performance - The net loss for the three months ended March 31, 2025, was $40.5 million, compared to a net income of $61.0 million for the same period in 2024, primarily due to collaboration revenue from a settlement agreement[160]. - Product sales, net for Q1 2025 were $34.9 million, an increase of approximately $10.1 million from $24.8 million in Q1 2024, driven by prescription growth of NEXLETOL and NEXLIZET[181]. - Collaboration revenue for Q1 2025 was $30.1 million, a decrease of $82.9 million from $113.0 million in Q1 2024, primarily due to a Settlement Agreement with DSE in Q1 2024[182]. - Cost of goods sold for Q1 2025 increased to $31.5 million from $10.1 million in Q1 2024, an increase of approximately $21.4 million, attributed to increased product sales and production-related write-offs[183]. - Net cash used in operating activities for Q1 2025 was $22.6 million, compared to $53.8 million provided in Q1 2024, reflecting increased commercialization costs[196]. Research and Development - Research and development expenses for the three months ended March 31, 2025, were $4.0 million, up from $1.5 million for the same period in 2024[166][167]. - The company plans to begin a Phase III pediatric trial and continue progressing its preclinical pipeline, anticipating increased research and development expenses in 2025[173]. - Research and development expenses for Q1 2025 were $12.6 million, a decrease of $0.8 million from $13.4 million in Q1 2024, mainly due to reduced compensation costs[184]. Regulatory and Market Developments - The FDA approved expanded indications for NEXLETOL and NEXLIZET in March 2024, enhancing their market potential[157]. - Otsuka filed a New Drug Application in Japan for bempedoic acid in November 2024, with expected approval in the second half of 2025[158]. Expenses and Financing - Selling, general and administrative expenses for Q1 2025 were $43.0 million, an increase of $1.0 million from $42.0 million in Q1 2024, primarily due to higher consulting and marketing costs[185]. - Interest expense for Q1 2025 was $19.4 million, up $5.4 million from $14.0 million in Q1 2024, mainly due to interest on the term loan[186]. - Future payments under the $150.0 million term loan include annual interest of approximately $14.6 million and principal repayments starting in 2028[201]. - The company expects to incur ongoing expenses and operating losses in the near term, necessitating additional financing to support operations and product development[160]. - The company expects to incur operating losses in the near term while commercializing NEXLETOL and NEXLIZET, relying on collaborations and potential milestone payments for funding[207]. - Future funding requirements will depend on various factors, including the ability to generate product revenues and establish favorable collaboration agreements[208]. Cash and Investments - As of March 31, 2025, cash and cash equivalents totaled $114.6 million, with investments in highly liquid, interest-bearing securities[193]. - The company repurchased Revenue Interests under the RIPA for $343.8 million, eliminating future payment obligations under this agreement[203]. - In January 2024, the company completed an offering of 56.7 million shares at $1.50 per share, raising approximately $90.7 million after expenses[204]. - The company has a Controlled Equity Offering Sales Agreement allowing for the issuance of up to $70.0 million in shares, although no shares were issued in the three months ended March 31, 2025[205]. - A Registered Direct Offering in March 2023 raised approximately $51.3 million after expenses, with additional proceeds of $5.8 million from warrant exercises in the three months ended March 31, 2024[206]. Risks and Market Conditions - Key risks include the successful development of products, debt maturity payments, and the establishment of favorable collaboration arrangements[211]. - There have been no material changes in market risk disclosures since the last annual report[210]. - The company currently has no off-balance sheet arrangements as defined by SEC rules[209].

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]

Core Insights - Esperion Therapeutics reported a quarterly loss of $0.21 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.18, and a decline from earnings of $0.34 per share a year ago, indicating an earnings surprise of -16.67% [1] - The company generated revenues of $65 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 12.58%, but down from $137.74 million year-over-year [2] - Esperion's shares have declined approximately 52.3% since the beginning of the year, contrasting with the S&P 500's decline of -3.9% [3] Earnings Outlook - The future performance of Esperion's stock will largely depend on management's commentary during the earnings call and the revisions of earnings estimates [4][5] - The current consensus EPS estimate for the upcoming quarter is -$0.14 on revenues of $64.91 million, and for the current fiscal year, it is -$0.09 on revenues of $338.51 million [7] Industry Context - The Medical - Drugs industry, to which Esperion belongs, is currently ranked in the top 22% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Metagenomi, is expected to report a quarterly loss of $0.62 per share, reflecting a year-over-year change of +47.9%, with revenues anticipated to be $8.75 million, down 21.6% from the previous year [9]

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 [7][19] - U.S. net product revenue increased 41% year over year to $34.9 million, driven by expanded label and commercial initiatives [7][19] - Collaboration revenue decreased approximately 73% to $30.1 million due to the settlement agreement milestone with DSE, but grew 97% excluding that milestone [21] Business Line Data and Key Metrics Changes - U.S. product sales growth was impacted by a flat lipid market and seasonal headwinds, with script growth increasing only 2% sequentially compared to Q4 2024 [7][20] - The market access team achieved significant milestones, including the removal of prior authorizations for over 30 plans, enhancing access for patients [8][10] - The company expanded its field reimbursement support team threefold to 15 specialists, improving support for prescribers [7][38] Market Data and Key Metrics Changes - The company reported that approximately 472,500 patients have been treated with its therapies in Europe, with royalty revenue from DSE increasing 8% from Q4 2024 to $10.5 million in Q1 2025 [13][14] - The Japanese market is expected to be a significant contributor, with approval for bempedoic acid anticipated in the second half of 2025 [14] Company Strategy and Development Direction - The company is focused on revenue growth, portfolio expansion, and pipeline advancement, with a commitment to improving cardiovascular health [5][23] - A new triple combination product is being developed, expected to provide significant LDL cholesterol reduction and is projected for commercialization in 2027 [12][62] - The company aims to leverage its leadership in ACLY biology and expand into high-need indications, such as primary sclerosing cholangitis (PSC) [16] Management's Comments on Operating Environment and Future Outlook - Management noted that the first quarter faced challenges due to changes in Medicare Part D and higher out-of-pocket costs, but early Q2 trends show prescription volume tracking approximately 8% higher than Q1 [20][58] - The management expressed confidence in the strategic initiatives to drive growth and improve patient access to innovative therapies [23][24] Other Important Information - The company reiterated its full-year 2025 operating expense guidance of approximately $215 million to $235 million, including $15 million in non-cash expenses related to stock compensation [22] - The company is actively pursuing new business development opportunities and is not waiting for specific milestones to execute deals [29] Q&A Session Summary Question: When should we expect a new business development deal? - Management is making good progress but will not set a timeline for a deal, as they want to ensure it makes sense for the company [29] Question: Is the triple combination a defensive strategy? - The triple combination is seen as a convenient option for patients, potentially being the most efficacious LDL-lowering drug on the market [31] Question: Is the sales force right-sized? - The current sales force of approximately 155 representatives is deemed appropriate, balancing personal and digital promotion [37] Question: How is the company addressing physician education on statin intolerance? - The company is focusing on educating physicians about statin intolerance, with significant traction in messaging about the unmet need for patients who cannot tolerate statins [40] Question: What is the gross margin trajectory? - Gross margin is influenced by the sales mix between U.S. and partner sales, with expectations for improvement as tech transfer progresses [65]

Exhibit 99.1 – Q1 2025 Total Revenue of $65.0 Million, a Decrease of 53% Y/Y; Adjusting for One Time Milestone Received in Q1 2024, Total Revenue Grew 63% Y/Y – Esperion Reports First Quarter 2025 Financial Results – Expanded Development Portfolio with Introduction of Novel Program Targeting Primary Sclerosing Cholangitis (PSC) – – Conference Call and Webcast Today at 8:00 a.m. ET – ANN ARBOR, Mich., May 6, 2025 (GLOBE NEWSWIRE) – Esperion (NASDAQ: ESPR) today reported financial results for the first quarte ...