Esperion(ESPR)
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Esperion Reaches Settlement Agreement with ANDA Filer, Dr. Reddy's Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Prior to April 19, 2040
Globenewswire· 2025-10-03 12:00
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]
Esperion Partner Otsuka Receives Regulatory Approval to Market NEXLETOL® in Japan for the Treatment of Hypercholesterolemia
Globenewswire· 2025-09-19 12:00
Core Insights - Esperion has received regulatory approval for NEXLETOL® (bempedoic acid) in Japan, marking a significant milestone in its international growth strategy [1][2] - The approval allows Esperion to expand its global footprint in the cardiovascular prevention market, which is crucial for patients needing non-statin LDL-C lowering therapies [2] - The partnership with Otsuka Pharmaceutical is expected to unlock substantial value in Japan, with Esperion set to receive milestone payments and tiered royalties based on sales performance [2] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medications for patients at risk of cardiovascular disease [3] - The company’s products are supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients, highlighting its commitment to addressing unmet medical needs [3] - Esperion is advancing its pipeline with a focus on developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design [3][4] Market Position - The approval of NEXLETOL in Japan, alongside existing approvals in the U.S. and Europe, positions Esperion as a key player in the global cardiovascular market [2] - The company aims to drive long-term growth and shareholder value through continued innovation and market expansion [2]
Esperion: A Mixture Of Opportunity And Risk: Why I Would Hold For Now
Seeking Alpha· 2025-09-09 19:10
Core Insights - Esperion Therapeutics, Inc. (NASDAQ: ESPR) has experienced significant stock price appreciation, exceeding 30% this month after reaching a 52-week low of below $1 in April [1] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing therapies for patients with elevated low-density lipoprotein cholesterol (LDL-C) [1] Market Performance - The stock's recovery indicates a positive market sentiment and potential investor confidence in the company's future prospects [1]
Esperion Therapeutics (NasdaqGM:ESPR) FY Conference Transcript
2025-09-08 19:02
Summary of UR Energy Conference Call Company Overview - UR Energy is a US-based producer, developer, and explorer for uranium, primarily operating in Wyoming, and is listed on the New York and Toronto stock exchanges. It is one of only three companies currently producing and selling uranium in the United States [2][3]. Key Properties - **Lost Creek**: - Produced approximately 3,000,000 pounds of uranium since 2013. - Contains over 12,000,000 pounds in measured and indicated resources and over 6,000,000 pounds in inferred resources. - Has a remaining mine life of thirteen years. - Year-to-date production for 2025 is over 200,000 pounds, with a full production capacity of 1,200,000 pounds per year. - Operating costs for the second quarter were $42.83 per pound, with an average contract price of $61.56 per pound for 2025 [3][4][8]. - **Shirley Basin**: - Contains 8,800,000 pounds of uranium in the measured and indicated category. - Full production capacity is 1,000,000 pounds per year, with construction well advanced and production startup targeted for early 2026 [4][5]. Market Dynamics - The US nuclear supply accounts for 20% of electricity consumption, with 440 nuclear reactors currently in operation and another 66 under construction, indicating growing demand for uranium [6][7]. - Geopolitical risks are significant, as Russia supplies 20% of enriched uranium and Kazakhstan produces approximately 46% of global supply [7]. - The US government is supporting the nuclear industry, with $2.7 billion allocated to enhance domestic fuel supply through the Nuclear Fuel Security Act [8]. Financial Insights - UR Energy closed July with $49.1 million in financing and has long-term contracts covering about 45% of production through 2023 [18][19]. - Current contracts are shifting from fixed pricing to a hybrid model that includes both fixed and market-related pricing, with fixed prices currently in the low seventies [30][32]. - The company aims to lock in contracts to ensure cash-positive sales, with a focus on increasing earnings per share through reliable production and managing operating costs [33][49]. Strategic Outlook - UR Energy is focused on ISR (In Situ Recovery) mining, with three properties: one in production (Lost Creek), one in construction (Shirley Basin), and one in exploration (Lost Soldier) [38]. - The company is optimistic about the future of uranium production in the US, anticipating a potential premium for US-produced uranium due to geopolitical factors [46][47]. - Analysts are generally positive about UR Energy's strategy, although there are concerns about accurately reflecting the current market environment in forecasts [37]. Additional Considerations - The company emphasizes its environmentally friendly practices, recycling 99.3% of water used in the extraction process [18]. - The transition to a hybrid pricing model reflects a broader trend in the uranium market, where contracts are becoming more flexible to adapt to market conditions [30][32].
Esperion Therapeutics, Inc. (ESPR) Presents At Cantor Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-08 02:17
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]
Top 2 Health Care Stocks That May Plunge This Month
Benzinga· 2025-09-05 14:39
Core Insights - Two stocks in the health care sector are signaling potential warnings for momentum-focused investors as of September 5, 2025 [1] Group 1: Esperion Therapeutics Inc (ESPR) - Esperion Therapeutics reported better-than-expected second-quarter financial results, highlighting a 15% sequential quarterly growth and 42% year-over-year growth in net U.S. product sales [7] - The company's stock surged approximately 56% over the past month, reaching a 52-week high of $3.94 [7] - The RSI value for Esperion is 85.7, indicating it is considered overbought [7] Group 2: Nuvation Bio Inc (NUVB) - Nuvation Bio reported an in-line loss for the second quarter but noted the FDA approval of IBTROZI, marking its transition into a commercial-stage company [8] - The stock gained around 44% over the past month, with a 52-week high of $3.48 [8] - The RSI value for Nuvation Bio is 81.8, also indicating it is considered overbought [8]
Esperion Therapeutics (ESPR) 2025 Conference Transcript
2025-09-03 14:47
Summary of Esperion Therapeutics (ESPR) Conference Call Company Overview - **Company**: Esperion Therapeutics (ESPR) - **Focus**: Commercialization of life-saving medications, specifically Nexlizet and Nexletol, with ongoing development of new compounds [7][8][60] Key Points Industry Context - **Cardiovascular Disease**: Identified as the number one killer globally, emphasizing the need for effective lipid-lowering therapies [10][12][43] - **Statin Intolerance**: Approximately 30% of patients cannot tolerate statins, creating a significant market opportunity for alternative therapies like Nexlizet [19][36] Product Performance - **Growth Metrics**: Double-digit growth reported in all metrics for Q2, indicating strong market momentum [7] - **Combination Therapy**: Emphasis on the need for combination therapies to achieve LDL-C goals, with Nexlizet showing 38% additional efficacy when added to statins [19][28] Market Strategy - **Geographic Expansion**: Strong traction in Europe, with potential for similar success in the U.S. and Japan, where statin intolerance is prevalent [31][32] - **Guideline Influence**: Received a Class 1A recommendation in new guidelines, positioning bempedoic acid as a foundational therapy [34][35][49] Financial Outlook - **Positive Financial Trajectory**: Achieved positive operating income for the first time from ongoing operations, with expectations for full profitability by Q1 2026 [67][68] - **Cash Position**: Ample cash reserves and reduced debt profile, supporting ongoing growth initiatives [69] Future Developments - **New Indications**: Exploring treatment for primary sclerosing cholangitis (PSC), with confidence in the unique mechanism of action of their compounds [60][62] - **Triple Oral Combination**: Development of a triple oral combination therapy expected to enhance LDL-C reduction efficacy [38][39] Consumer Engagement - **Marketing Initiatives**: Upcoming consumer-directed commercials aimed at educating patients about heart health and the importance of treatment adherence [25][27] Competitive Landscape - **Market Positioning**: While competition exists, the unique efficacy and combination potential of Nexlizet provide a strong market position [45][46] Additional Insights - **Patient Education**: Importance of educating patients about their cardiovascular risk to encourage adherence to treatment [21][22] - **Regulatory Milestones**: Anticipated regulatory approvals in Japan tied to significant financial milestones, indicating a robust partnership with Otsuka [70][71] This summary encapsulates the key insights from the conference call, highlighting Esperion Therapeutics' strategic focus, market opportunities, and financial health.
Esperion’s Bempedoic Acid Receives Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidaemias
Globenewswire· 2025-08-29 12:00
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]
Esperion to Participate in Upcoming September Investor Conferences
Globenewswire· 2025-08-26 12:00
Company Overview - Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on developing new medicines for unmet patient needs, particularly in cardiovascular disease [3] - The company has developed the only FDA-approved oral, once-daily, non-statin medications for patients with elevated low-density lipoprotein cholesterol (LDL-C) [3] - Esperion's medications are supported by the CLEAR Cardiovascular Outcomes Trial, which involved nearly 14,000 patients [3] Upcoming Events - Esperion will participate in the Cantor Global Healthcare Conference in New York on September 3, 2025, at 9:45 a.m. ET [1] - The company will also attend the H.C. Wainwright 27th Annual Global Investment Conference in New York on September 8, 2025, at 2:00 p.m. ET [1] Webcast Information - Live webcasts of the events can be accessed on the investor and media section of the Esperion website [2] - Replay of the webcasts will be available approximately two hours after the events and archived for about 90 days [2] Strategic Focus - Esperion is advancing its pre-clinical pipeline and focusing on developing ATP citrate lyase inhibitors (ACLYi) [3][4] - The company aims to leverage new insights into the structure and function of ACLYi for rational drug design, targeting the development of highly potent and specific inhibitors [3]
Esperion(ESPR) - 2025 Q2 - Quarterly Report
2025-08-13 20:07
```markdown [PART I — FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed interim financial statements, including balance sheets, statements of operations, and cash flows, with detailed notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets%20at%20June%2030%2C%202025%20and%20December%2031%2C%202024) This table provides a snapshot of the company's assets, liabilities, and stockholders' deficit at specific interim periods | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | Cash and cash equivalents | $86,061 | $144,761 | | Accounts receivable, net | $107,746 | $80,142 | | Inventories, net | $114,466 | $94,491 | | Total current assets | $342,595 | $337,998 | | Total assets | $347,085 | $343,821 | | **Liabilities and Stockholders' Deficit** | | Accounts payable | $74,704 | $51,650 | | Convertible notes, net of issuance costs (current) | $54,766 | $54,575 | | Royalty sale liability (current) | $66,312 | $47,586 | | Deferred revenue from collaborations | $22,313 | $8,518 | | Total current liabilities | $298,796 | $246,233 | | Convertible notes, net of issuance costs (non-current) | $96,998 | $96,745 | | Royalty sale liability (non-current) | $229,600 | $246,024 | | Long-term debt | $146,452 | $140,971 | | Total liabilities | $780,594 | $732,543 | | Total stockholders' deficit | $(433,509) | $(388,722) | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20(Loss)%20Income%20for%20the%20three%20and%20six%20month%20periods%20ended%20June%2030%2C%202025%20and%202024) This table details the company's revenues, operating expenses, and net loss for the three and six months ended June 30, 2025 and 2024 | (in thousands, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Revenues:** | | Product sales, net | **$40,274** | **$28,302** | **$75,187** | **$53,058** | | Collaboration revenue | **$42,111** | **$45,532** | **$72,193** | **$158,511** | | Total Revenues | **$82,385** | **$73,834** | **$147,380** | **$211,569** | | **Operating expenses:** | | Cost of goods sold | **$28,543** | **$15,609** | **$60,081** | **$25,684** | | Research and development | **$7,238** | **$11,461** | **$19,795** | **$24,864** | | Selling, general and administrative | **$39,509** | **$44,185** | **$82,505** | **$86,173** | | Total operating expenses | **$75,290** | **$71,255** | **$162,381** | **$136,721** | | Income (loss) from operations | **$7,095** | **$2,579** | **$(15,001)** | **$74,848** | | Interest expense | **$(20,486)** | **$(13,723)** | **$(39,917)** | **$(27,747)** | | Loss on extinguishment of debt | — | **$(53,235)** | — | **$(53,235)** | | Other income, net | **$666** | **$2,454** | **$1,738** | **$5,231** | | Net loss | **$(12,725)** | **$(61,925)** | **$(53,180)** | **$(903)** | | Net loss per common share - basic and diluted | **$(0.06)** | **$(0.33)** | **$(0.27)** | **$(0.01)** | | Weighted-average shares outstanding - basic and diluted | **197,546,239** | **188,793,816** | **196,841,011** | **179,026,191** | | Comprehensive loss | **$(12,725)** | **$(61,925)** | **$(53,180)** | **$(903)** | [Condensed Statements of Stockholders' Deficit](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Deficit%20for%20the%20three%20and%20six%20month%20periods%20ended%20June%2030%2C%202025%20and%202024) This table outlines changes in the company's stockholders' deficit, including common stock, additional paid-in capital, and accumulated deficit | (in thousands, except share data) | Common Stock Shares (June 30, 2025) | Common Stock Amount (June 30, 2025) | Additional Paid-In Capital (June 30, 2025) | Accumulated Deficit (June 30, 2025) | Total Stockholders' Deficit (June 30, 2025) | | :--- | :--- | :--- | :--- | :--- | :--- | | Balance at December 31, 2024 | **195,852,463** | **$196** | **$1,267,109** | **$(1,601,029)** | **$(388,722)** | | Vesting of restricted stock units | **1,291,169** | **$1** | — | — | **$1** | | Vesting of ESPP shares | **346,129** | — | **$500** | — | **$500** | | Stock-based compensation | — | — | **$5,134** | — | **$5,134** | | Issuance of common stock from ATM program, net | **2,665,505** | **$3** | **$2,755** | — | **$2,758** | | Net loss | — | — | — | **$(53,180)** | **$(53,180)** | | Balance at June 30, 2025 | **200,155,266** | **$200** | **$1,275,498** | **$(1,654,209)** | **$(433,509)** | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20six%20month%20periods%20ended%20June%2030%2C%202025%20and%202024) This table summarizes the cash flows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | **$(54,050)** | **$46,623** | | Net cash (used in) investing activities | — | **$(150)** | | Net cash (used in) provided by financing activities | **$(4,650)** | **$60,583** | | Net (decrease) increase in cash and cash equivalents | **$(58,700)** | **$107,056** | | Cash and cash equivalents at beginning of period | **$144,761** | **$82,248** | | Cash and cash equivalents at end of period | **$86,061** | **$189,304** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed interim financial statements [1. The Company and Basis of Presentation](index=7&type=section&id=1.%20The%20Company%20and%20Basis%20of%20Presentation) This note describes the company's business, its focus on biopharmaceutical products, and the basis for financial statement preparation - Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medicines (NEXLETOL®, NEXLIZET®, NILEMDO®, NUSTENDI®) for patients at risk for cardiovascular disease (CVD) and elevated low-density lipoprotein cholesterol (LDL-C)[19](index=19&type=chunk)[20](index=20&type=chunk) - The company's products received expanded indications from the FDA in March **2024** and the European Commission (EC) in May **2024** for cardiovascular risk reduction and expanded LDL-C lowering[20](index=20&type=chunk) - Esperion has sustained annual operating losses since inception and expects these to continue, necessitating potential future funding through collaborations, debt, or equity offerings[22](index=22&type=chunk)[23](index=23&type=chunk) [2. Summary of Significant Accounting Policies](index=8&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles, judgments, and estimates applied in preparing the financial statements - The company operates and manages its business as a single operating segment focused on researching, developing, and commercializing therapies for elevated LDL-C[26](index=26&type=chunk) - A significant concentration of credit risk exists, with three customers accounting for approximately **99%** of trade receivables and **98%** of gross sales for the six months ended June **30**, **2025** and **2024**[29](index=29&type=chunk) - Revenue is primarily derived from collaboration agreements (royalties, bulk tablet sales) and net product sales of NEXLETOL and NEXLIZET in the U.S[30](index=30&type=chunk) Product Sales, Net | Period | Product Sales, Net (in thousands) | | :--- | :--- | | Three Months Ended June 30, 2025 | **$40,274** | | Six Months Ended June 30, 2025 | **$75,187** | - The company is evaluating the impacts of recently issued accounting pronouncements: ASU **2023-09** (Income Taxes, effective Dec **2025**) and ASU **2024-03** (Disaggregation of Income Statement Expenses, effective Dec **2026**)[50](index=50&type=chunk)[51](index=51&type=chunk) [3. Collaborations with Third Parties](index=11&type=section&id=3.%20Collaborations%20with%20Third%20Parties) This note details the company's agreements with external partners for product development, commercialization, and revenue sharing - Under the DSE Agreement, Esperion received **$125.0 million** in **2024** (**$100.0 million** upfront and a **$25.0 million** milestone payment) to resolve a commercial dispute and for EMA approval of updated labels for NILEMDO and NUSTENDI[56](index=56&type=chunk)[58](index=58&type=chunk) Collaboration Revenue from DSE | Period | Collaboration Revenue (in thousands) | | :--- | :--- | | Three Months Ended June 30, 2025 | ~**$41,000** | | Six Months Ended June 30, 2025 | ~**$70,400** | - Otsuka (Japan) filed a New Drug Application (NDA) for bempedoic acid in November **2024**, with expected approval and National Health Insurance (NHI) pricing in the second half of **2025**. Esperion is eligible for up to **$450.0 million** in milestones and tiered **15-30%** royalties[20](index=20&type=chunk)[61](index=61&type=chunk) Collaboration Revenue from DS | Period | Collaboration Revenue (in thousands) | | :--- | :--- | | Three Months Ended June 30, 2025 | **$100** | | Six Months Ended June 30, 2025 | **$500** | - New license and distribution agreements were signed with CSL Seqirus for Australia/New Zealand (Feb **2025**) and HLS Therapeutics Inc. for Canada (May **2025**), including upfront/near-term milestone payments and royalties[69](index=69&type=chunk)[70](index=70&type=chunk) [4. Inventories, net](index=13&type=section&id=4.%20Inventories%2C%20net) This note provides a breakdown of the company's inventory components and related valuation adjustments Inventories, Net | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Raw materials | **$107,182** | **$84,584** | | Work in process | **$3,785** | **$3,711** | | Finished goods | **$3,499** | **$6,196** | | Total Inventories, net | **$114,466** | **$94,491** | | Inventory reserves | **$4,500** | **$300** | [5. Commitments and Contingencies (ANDA Litigation)](index=14&type=section&id=5.%20Commitments%20and%20Contingencies) This note describes the company's legal obligations and potential liabilities, particularly regarding ANDA litigation - The company is involved in ANDA litigation against nine pharmaceutical companies seeking approval for generic versions of NEXLETOL and/or NEXLIZET[72](index=72&type=chunk)[74](index=74&type=chunk) - Settlement agreements were reached with Micro Labs, Hetero USA, and Accord Healthcare Inc., preventing them from marketing generic NEXLETOL in the U.S. prior to April **19**, **2040**[75](index=75&type=chunk) - The patent litigation against the remaining defendants is ongoing, with a trial anticipated to begin no earlier than January **2027**[76](index=76&type=chunk) [6. Cash Equivalents](index=14&type=section&id=6.%20Cash%20Equivalents) This note details the composition of the company's cash equivalents and related interest income Cash Equivalents | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Money market funds | **$66,840** | **$106,894** | | Certificates of deposit | **$404** | **$403** | | Total | **$67,244** | **$107,297** | Interest Income on Cash Equivalents | Period | Interest Income (in thousands) | | :--- | :--- | | Three Months Ended June 30, 2025 | **$600** | | Three Months Ended June 30, 2024 | **$2,400** | | Six Months Ended June 30, 2025 | **$1,700** | | Six Months Ended June 30, 2024 | **$4,800** | [7. Fair Value Measurements](index=15&type=section&id=7.%20Fair%20Value%20Measurements) This note explains how the company measures certain financial assets and liabilities at fair value Financial Assets Measured at Fair Value (Level 1) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Money market funds | **$66,840** | **$106,894** | | Certificates of deposit | **$404** | **$403** | | Total assets at fair value | **$67,244** | **$107,297** | - All financial assets measured at fair value are classified as Level **1**, indicating they are based on quoted prices for identical assets in active markets[81](index=81&type=chunk) [8. Liability Related to the Revenue Interest Purchase Agreement](index=16&type=section&id=8.%20Liability%20Related%20to%20the%20Revenue%20Interest%20Purchase%20Agreement) This note discusses the company's obligations arising from the Revenue Interest Purchase Agreement and its subsequent termination - The Revenue Interest Purchase Agreement (RIPA) with Oberland was repurchased and terminated on June **27**, **2024**, for a cash payment of **$343.8 million**[88](index=88&type=chunk) - A loss on debt extinguishment of **$53.2 million** was recorded for the three and six months ended June **30**, **2024**, due to the RIPA repurchase[89](index=89&type=chunk) Interest Expense Related to RIPA | Period | Interest Expense (in thousands) | | :--- | :--- | | Three Months Ended June 30, 2025 | — | | Three Months Ended June 30, 2024 | ~**$10,600** | | Six Months Ended June 30, 2025 | — | | Six Months Ended June 30, 2024 | ~**$21,600** | [9. Sale of Future Royalties](index=17&type=section&id=9.%20Sale%20of%20Future%20Royalties) This note describes the transaction involving the sale of future royalty streams and the associated liability - On June **27**, **2024**, Esperion sold a portion of future royalties from DSE net sales to OCM IP Healthcare Portfolio LP (OMERS) for **$304.7 million**, treated as a debt instrument[92](index=92&type=chunk)[94](index=94&type=chunk) - OMERS will receive **100%** of the Royalty Interests until an aggregate amount of **1.7x** the purchase price (**$517.9 million**) is received, after which royalties revert to Esperion[93](index=93&type=chunk) Royalty Sale Liability and Interest Expense | Metric | June 30, 2025 (in thousands) | | :--- | :--- | | Royalty sale liability, net | **$295,912** | | Interest expense (3 months ended June 30, 2025) | **$13,300** | | Interest expense (6 months ended June 30, 2025) | **$26,400** | | Effective annual imputed interest rate | **1.5%** | | Royalties recognized and settled to Purchaser (6 months ended June 30, 2025) | **$(24,061)** | [10. Debt](index=18&type=section&id=10.%20Debt) This note provides details on the company's various debt instruments, including term loans and convertible notes - On December **13**, **2024**, the company entered into a Credit Agreement for a **$150.0 million** term loan, bearing interest at **9.75%** (cash) or **11.75%** (paid-in-kind) annually, maturing December **13**, **2029**[99](index=99&type=chunk)[100](index=100&type=chunk) Debt Balances and Interest Expense | Debt Type | Principal Amount (June 30, 2025, in thousands) | Net Carrying Amount (June 30, 2025, in thousands) | Interest Expense (3 months ended June 30, 2025, in thousands) | Interest Expense (6 months ended June 30, 2025, in thousands) | | :--- | :--- | :--- | :--- | :--- | | Term Loan | **$150,000** (approx.) | **$146,452** | **$5,000** | **$9,100** | | 2025 Notes | **$54,900** | **$54,766** | **$700** | **$1,300** | | 2030 Notes | **$100,000** | **$96,998** | **$1,500** | **$3,100** | - The company issued **$100.0 million** aggregate principal amount of **5.75%** Convertible Senior Subordinated Notes due June **2030** on December **17**, **2024**, with an initial conversion price of approximately **$3.06** per share[116](index=116&type=chunk)[117](index=117&type=chunk) Estimated Future Principal Payments | Years Ending December 31, | (in thousands) | | :--- | :--- | | 2025 | **$54,912** | | 2026 | — | | 2027 | — | | 2028 | **$19,301** | | 2029 | **$135,105** | | 2030 | **$100,000** | | Total | **$309,318** | [11. Other Accrued Liabilities](index=22&type=section&id=11.%20Other%20Accrued%20Liabilities) This note itemizes various accrued expenses and short-term obligations of the company Other Accrued Liabilities | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accrued legal fees | **$3,753** | **$698** | | Accrued compensation | **$8,370** | **$12,739** | | Accrued professional fees | **$2,202** | **$3,557** | | Accrued interest on convertible notes | **$530** | **$1,229** | | Accrued other | **$600** | **$1,370** | | Total other accrued liabilities | **$15,455** | **$19,593** | [12. Stock Compensation](index=22&type=section&id=12.%20Stock%20Compensation) This note explains the company's stock-based compensation plans and the associated expense recognition - The **2022** Stock Option and Incentive Plan's reserved shares increased to **23,150,000** in May **2025**[131](index=131&type=chunk) Stock-Based Compensation Expense | (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Research and development | **$412** | **$781** | | Selling, general and administrative | **$2,257** | **$4,353** | | Total stock compensation expense | **$2,669** | **$5,134** | Outstanding Stock Options and RSUs | Metric | June 30, 2025 | | :--- | :--- | | Stock Options Outstanding | **6,864,243** | | RSUs Outstanding and Unvested | **8,034,122** | | Unrecognized stock-based compensation expense (unvested options) | **$4,900** (over **2.6** years) | | Unrecognized stock-based compensation expense (unvested RSUs) | **$15,000** (over **2.9** years) | [13. Income Taxes](index=25&type=section&id=13.%20Income%20Taxes) This note discusses the company's income tax position, including deferred tax assets and valuation allowances - No provision for income taxes was recorded for the three and six months ended June **30**, **2025** and **2024**, due to sustained annual operating losses since inception[142](index=142&type=chunk) - A full valuation allowance has been applied against net deferred tax assets, as it is not more likely than not that the company will realize their benefit[142](index=142&type=chunk) - The company is evaluating the implications of the One Big Beautiful Bill Act (OBBBA), signed July **4**, **2025**, which includes changes to corporate taxation such as R&D expense capitalization and interest expense limitations[143](index=143&type=chunk) [14. Segment Reporting](index=25&type=section&id=14.%20Segment%20Reporting) This note clarifies the company's operating segments and the breakdown of its revenue streams - The company operates as a single reportable segment, focusing on researching, developing, and commercializing therapies for elevated LDL-C[144](index=144&type=chunk) Segment Revenue Breakdown | Revenue Type | Three Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | | :--- | :--- | :--- | | Net product sales | **$40,300** | **$75,200** | | Collaboration revenue | **$42,100** | **$72,200** | - Collaboration revenue for the periods ended June **30**, **2025**, was primarily derived from the company's European partner, DSE[144](index=144&type=chunk) [15. Stockholders' Deficit](index=26&type=section&id=15.%20Stockholders'%20Deficit) This note provides further details on changes in the company's equity, including stock issuances and warrants - The January **2024** public offering generated approximately **$90.7 million** in net proceeds from the sale of **65,205,000** shares of Common Stock[146](index=146&type=chunk) - Under the **2023** ATM Program, **2,665,505** shares of Common Stock were issued during the six months ended June **30**, **2025**, yielding approximately **$2.8 million** in net proceeds[147](index=147&type=chunk) Warrants Outstanding | Warrant Type | June 30, 2025 | December 31, 2024 | Weighted-Average Exercise Price | | :--- | :--- | :--- | :--- | | From Warrant Amendment Agreements | **6,071,429** | **6,071,429** | **$1.55** | | From 2023 Purchase Agreement | **20,000,000** | **20,000,000** | **$1.55** | | Total warrants outstanding | **26,071,429** | **26,071,429** | | [16. Net Loss Per Common Share](index=27&type=section&id=16.%20Net%20Loss%20Per%20Common%20Share) This note presents the calculation of basic and diluted net loss per common share Net Loss Per Common Share | Period | Net Loss Per Common Share - Basic and Diluted | | :--- | :--- | | Three Months Ended June 30, 2025 | **$(0.06)** | | Six Months Ended June 30, 2025 | **$(0.27)** | - A total of **76,180,919** potential dilutive shares were excluded from the calculation of diluted net loss per share for the six months ended June **30**, **2025**, due to their anti-dilutive effect[155](index=155&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes the company's financial condition, operating results, liquidity, and capital resources for the interim periods [Forward-Looking Statements](index=29&type=section&id=Forward-Looking%20Statements) This section cautions that statements made are forward-looking and subject to risks and uncertainties that could cause actual results to differ - This section contains forward-looking statements based on management's beliefs and assumptions, which involve known and unknown risks and uncertainties that could cause actual results to differ materially[157](index=157&type=chunk)[158](index=158&type=chunk) [Overview](index=29&type=section&id=Overview) This section provides a high-level summary of the company's business, product portfolio, recent developments, and financial outlook - Esperion is a commercial stage biopharmaceutical company focused on FDA-approved oral, once-daily, non-statin medicines (NEXLETOL®, NEXLIZET®) for cardiovascular disease and elevated LDL-C[160](index=160&type=chunk)[161](index=161&type=chunk) - The company received expanded indications for its products from the FDA in March **2024** and the EC in May **2024**, and its Japanese collaborator, Otsuka, filed an NDA in November **2024** with expected approval in H**2** **2025**[161](index=161&type=chunk)[162](index=162&type=chunk) - Esperion has incurred net losses since inception and expects continued operating losses, requiring additional financing to support ongoing commercialization and research and development activities[163](index=163&type=chunk)[164](index=164&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section discusses accounting policies requiring management's most difficult, subjective, or complex judgments and estimates - The preparation of financial statements requires management to make estimates and judgments, particularly concerning net product sales and royalty purchase agreements, with actual results potentially differing from these estimates[182](index=182&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, comparing revenues and expenses over different periods [Comparison of the Three Months Ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares the company's financial results for the second quarter of 2025 against the same period in 2024 Financial Performance (Three Months Ended June 30) | (in thousands) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product sales, net | **$40,274** | **$28,302** | **$11,972** (↑**42.3%**) | | Collaboration revenue | **$42,111** | **$45,532** | **$(3,421)** (↓**7.5%**) | | Cost of goods sold | **$28,543** | **$15,609** | **$12,934** (↑**82.9%**) | | Research and development | **$7,238** | **$11,461** | **$(4,223)** (↓**36.8%**) | | Selling, general and administrative | **$39,509** | **$44,185** | **$(4,676)** (↓**10.6%**) | | Income from operations | **$7,095** | **$2,579** | **$4,516** (↑**175.1%**) | | Interest expense | **$(20,486)** | **$(13,723)** | **$(6,763)** (↑**49.3%**) | | Loss on extinguishment of debt | — | **$(53,235)** | **$53,235** (↓**100%**) | | Net loss | **$(12,725)** | **$(61,925)** | **$49,200** (↓**79.4%**) | - The significant decrease in net loss for Q**2** **2025** compared to Q**2** **2024** was primarily due to the absence of a **$53.2 million** loss on extinguishment of debt in **2025**[184](index=184&type=chunk)[191](index=191&type=chunk) - Product sales increased due to higher prescription volumes, while collaboration revenue decreased primarily due to a one-time settlement payment received in Q**2** **2024**[185](index=185&type=chunk)[186](index=186&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=34&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section compares the company's financial performance for the first half of 2025 against the same period in 2024 Financial Performance (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Product sales, net | **$75,187** | **$53,058** | **$22,129** (↑**41.7%**) | | Collaboration revenue | **$72,193** | **$158,511** | **$(86,318)** (↓**54.5%**) | | Cost of goods sold | **$60,081** | **$25,684** | **$34,397** (↑**133.9%**) | | Research and development | **$19,795** | **$24,864** | **$(5,069)** (↓**20.4%**) | | Selling, general and administrative | **$82,505** | **$86,173** | **$(3,668)** (↓**4.3%**) | | Income (loss) from operations | **$(15,001)** | **$74,848** | **$(89,849)** (↓**120.0%**) | | Interest expense | **$(39,917)** | **$(27,747)** | **$(12,170)** (↑**43.8%**) | | Loss on extinguishment of debt | — | **$(53,235)** | **$53,235** (↓**100%**) | | Net loss | **$(53,180)** | **$(903)** | **$(52,277)** (↑**5789.3%**) | - The substantial increase in net loss for the six months ended June **30**, **2025**, was primarily driven by an **$86.3 million** decrease in collaboration revenue (due to a one-time settlement in **2024**) and higher cost of goods sold and interest expense[193](index=193&type=chunk)[195](index=195&type=chunk)[196](index=196&type=chunk)[199](index=199&type=chunk) - Product sales increased by **$22.1 million** due to prescription growth, while R&D and SG&A expenses decreased[194](index=194&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to generate and manage cash, its funding sources, and future capital requirements - As of June **30**, **2025**, primary liquidity sources were cash and cash equivalents totaling **$86.1 million**[208](index=208&type=chunk) Cash Flow Summary (Six Months Ended June 30) | (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | **$(54,050)** | **$46,623** | | Net cash (used in) investing activities | — | **$(150)** | | Net cash (used in) provided by financing activities | **$(4,650)** | **$60,583** | | Net (decrease) increase in cash and cash equivalents | **$(58,700)** | **$107,056** | | Cash and cash equivalents at beginning of period | **$144,761** | **$82,248** | | Cash and cash equivalents at end of period | **$86,061** | **$189,304** | - Key financing activities in **2024** included **$125.0 million** from the DSE Settlement, **$90.7 million** from a public offering, **$304.7 million** from a royalty sale, and a **$150.0 million** term loan. In **2025**, the ATM program generated **$2.8 million**[204](index=204&type=chunk)[205](index=205&type=chunk)[203](index=203&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) - The company anticipates current cash, future product sales, and collaboration revenues will fund operations for the foreseeable future, but may seek additional financing due to ongoing operating losses and R&D expenses[207](index=207&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section reports no material changes to market risk disclosures since the December 31, 2024 Annual Report on Form 10-K - No material changes to quantitative and qualitative disclosures about market risk since the Annual Report on Form **10-K** for the fiscal year ended December **31**, **2024**[225](index=225&type=chunk) [Item 4. Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were ineffective as of June 30, 2025, due to a material weakness in inventory accounting, though financial statements are fairly presented - The company's disclosure controls and procedures were not effective as of June **30**, **2025**[228](index=228&type=chunk) - A material weakness in internal control over financial reporting was identified, related to the accounting for inventory held at a third-party contract manufacturing organization[229](index=229&type=chunk)[243](index=243&type=chunk) - Management is designing and implementing enhanced controls to remediate the material weakness, focusing on inventory existence and movements between contract manufacturing organizations[231](index=231&type=chunk)[244](index=244&type=chunk) - Despite the material weakness, management concluded that the condensed financial statements for the periods presented are fairly presented in conformity with U.S. GAAP[230](index=230&type=chunk) [PART II — OTHER INFORMATION](index=41&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to Note 5 for details on ANDA litigation and anticipates no material adverse impact from other legal matters - Information on legal proceedings, including ANDA litigation, is incorporated by reference from Note **5** to the condensed financial statements[233](index=233&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) This section outlines new or materially changed risk factors, including internal control weaknesses, regulatory pressures, and macroeconomic volatility - A material weakness in internal control over financial reporting has been identified, which could impair the ability to produce accurate and timely financial statements and harm operating results[237](index=237&type=chunk)[240](index=240&type=chunk)[242](index=242&type=chunk) - Inadequate funding for government agencies (FDA, SEC) or other disruptions could hinder timely product development, commercialization, and regulatory reviews[246](index=246&type=chunk)[247](index=247&type=chunk) - Recent federal legislation, including the Inflation Reduction Act of **2022** (IRA) and the One Big Beautiful Bill Act of **2025** (OBBBA), along with executive orders, may increase pressure to reduce pharmaceutical product prices paid by Medicare, potentially adversely affecting revenue[248](index=248&type=chunk)[249](index=249&type=chunk)[253](index=253&type=chunk) - Unfavorable macroeconomic conditions, market volatility from geopolitical developments, high inflation, and rising interest rates could adversely affect business operations, demand for products, and ability to raise capital[256](index=256&type=chunk)[259](index=259&type=chunk) - Changes in tax law, such as those introduced by the OBBBA, could adversely affect the company's business and financial condition[261](index=261&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the quarter - No Rule **10b5-1** or non-Rule **10b5-1** trading arrangements were adopted or terminated by directors or officers during the quarter ended June **30**, **2025**[262](index=262&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with this Quarterly Report on Form 10-Q, including corporate governance documents and certifications - The exhibit index lists various documents, including the Amended and Restated Certificate of Incorporation, Bylaws, specimen common stock certificate, and certifications of principal executive and financial officers[265](index=265&type=chunk) ```