Part I [Item 1. Business](index=7&type=section&id=Item%201.%20Business) Esperion Therapeutics develops and commercializes oral, non-statin medicines for elevated LDL-C, with key products NEXLETOL® and NEXLIZET® approved in 2020, and recently completed a successful cardiovascular outcomes trial for expanded indication submission [Overview and Product Information](index=7&type=section&id=Overview%20and%20Product%20Information) Esperion specializes in oral, non-statin LDL-C lowering medicines, with NEXLETOL® and NEXLIZET® approved in 2020, and recently completed its CLEAR Outcomes trial, meeting its primary endpoint for a planned CV risk reduction indication submission - Esperion focuses on developing and commercializing oral, once-daily, non-statin medicines for patients with elevated low-density lipoprotein cholesterol (LDL-C)[24](index=24&type=chunk) - The company's main products are NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe), approved by the FDA in February **2020**. They are also approved in Europe as NILEMDO® and NUSTENDI®[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) - The global cardiovascular outcomes trial (CVOT), CLEAR Outcomes, met its primary endpoint of reducing four-component MACE. The company plans to submit for a CV risk reduction indication in the U.S. and Europe in the first half of **2023**[25](index=25&type=chunk) [Market Opportunity and Competitive Landscape](index=8&type=section&id=Market%20Opportunity%20and%20Competitive%20Landscape) A significant market opportunity exists for LDL-C lowering therapies, with millions of U.S. patients needing additional treatment or being statin intolerant, amidst a competitive landscape of established and newer therapies - An estimated **8.7 million** U.S. patients currently taking statins require additional LDL-C lowering[47](index=47&type=chunk) - Approximately **9.6 million** U.S. patients are not on statins but need LDL-C lowering, with most considered statin intolerant[48](index=48&type=chunk) - Key competitors include generic statins, ezetimibe, injectable PCSK9 inhibitors like Praluent®, Repatha®, and Leqvio®, and triglyceride-lowering therapies like Vascepa®[50](index=50&type=chunk)[54](index=54&type=chunk)[58](index=58&type=chunk) [Revenue, Expenses, and Collaborations](index=13&type=section&id=Revenue%2C%20Expenses%2C%20and%20Collaborations) Esperion generates revenue from U.S. product sales and ex-U.S. collaborations, with 2022 net product sales of **$55.9 million** and R&D expenses of **$118.9 million**, while relying on third-party manufacturing and key commercial partners Revenue Breakdown (Year Ended Dec 31) | Revenue Source | 2022 | 2021 | | :--- | :--- | :--- | | Net Product Sales | $55.9 million | $40.0 million | | Collaboration Revenue | $19.6 million | $38.4 million | - Research and development expenses for the year ended December 31, **2022**, were **$118.9 million**, primarily related to the CLEAR Outcomes CVOT[70](index=70&type=chunk) - The company has exclusive commercialization agreements with Daiichi Sankyo Europe (DSE) for Europe, Otsuka for Japan, and Daiichi Sankyo Co. Ltd (DS) for South Korea, Taiwan, and other territories[77](index=77&type=chunk)[78](index=78&type=chunk)[80](index=80&type=chunk) [Intellectual Property](index=14&type=section&id=Intellectual%20Property) Esperion's intellectual property portfolio, crucial for its business, includes numerous U.S. and foreign patents, with the core bempedoic acid patent expiring in December **2025**, and other patents extending to **2036** and **2040** - The primary U.S. patent for bempedoic acid (No. 7,335,799) is scheduled to expire in December **2025**, with a potential five-year extension requested[85](index=85&type=chunk) - A patent covering methods of treating familial hypercholesterolemia with the bempedoic acid / ezetimibe combination tablet (U.S. Patent No. 10,912,751) is scheduled to expire in March **2036**[87](index=87&type=chunk) - A patent family related to the manufacturing of high-purity bempedoic acid, including U.S. Patent No. 11,407,705, is scheduled to expire in June **2040**[86](index=86&type=chunk) [Regulatory Matters](index=17&type=section&id=Regulatory%20Matters) Esperion operates under extensive regulatory oversight, including lengthy drug approval processes, post-marketing requirements, and complex laws concerning pricing, reimbursement, healthcare fraud, and data privacy - The FDA drug approval process involves extensive preclinical testing, an Investigational New Drug (IND) application, and three phases of human clinical trials to establish safety and efficacy[100](index=100&type=chunk)[106](index=106&type=chunk) - As a condition of NEXLETOL and NEXLIZET approval, the FDA required post-marketing studies, including a pediatric study, a pregnancy exposure study, a lactation study, and the completion of the CLEAR CVOT[116](index=116&type=chunk) - In the EU, innovative drugs can qualify for **eight years** of data exclusivity and an additional **two years** of market exclusivity, protecting them from generic competition[168](index=168&type=chunk) - The company is subject to numerous healthcare laws, including the federal Anti-Kickback Statute, the False Claims Act, and data privacy regulations like HIPAA in the U.S. and GDPR in Europe[149](index=149&type=chunk)[151](index=151&type=chunk)[158](index=158&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Esperion faces significant risks including dependence on product commercial success, potential failure to secure expanded regulatory approvals, reliance on third-party manufacturing, intense competition, intellectual property litigation, and the need for additional capital amidst a history of losses - The company depends almost entirely on the success of its two products, bempedoic acid and the bempedoic acid / ezetimibe combination tablet, and there is no assurance commercialization will be successful or generate expected revenues[197](index=197&type=chunk) - While the CLEAR CVOT met its primary endpoint, regulatory authorities may not approve expanded indications, which could prevent the company from receiving significant milestone payments and generating additional revenue[12](index=12&type=chunk) - The company may need substantial additional capital in the future, and if it is not available, operations may have to be delayed, reduced, or ceased[299](index=299&type=chunk) - Servicing debt, including convertible notes and obligations under the Revenue Interest Purchase Agreement (RIPA), requires significant cash and may not be supported by cash flow from operations[304](index=304&type=chunk)[310](index=310&type=chunk) [Item 1B. Unresolved Staff Comments](index=71&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the Securities and Exchange Commission - There are no unresolved staff comments[382](index=382&type=chunk) [Item 2. Properties](index=71&type=section&id=Item%202.%20Properties) The company's corporate headquarters are located in Ann Arbor, Michigan, where it leases approximately **19,400 square feet** of office space, which will be reduced to approximately **11,500 square feet** effective November 1, **2023** - Corporate headquarters are in Ann Arbor, Michigan, with leased office space of approximately **19,400 square feet**[383](index=383&type=chunk) - Effective November 1, **2023**, the leased office space will be reduced to approximately **11,500 square feet**[383](index=383&type=chunk) [Item 3. Legal Proceedings](index=71&type=section&id=Item%203.%20Legal%20Proceedings) A 2016 securities class action lawsuit was settled in 2021, with the company and its insurers paying **$18.25 million** to the plaintiff class, and no other current legal matters are anticipated to have a material adverse impact - A **2016** securities class action lawsuit was settled in **2021**, with the company and its insurers paying **$18.25 million** to the plaintiff class[185](index=185&type=chunk) - The company recorded a loss on settlement of **$13.25 million** in Q1 **2021**, representing the **$18.25 million** settlement offset by **$5.0 million** in insurance proceeds[185](index=185&type=chunk) [Item 4. Mine Safety Disclosures](index=71&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - Not applicable[386](index=386&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=72&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Esperion's common stock trades on NASDAQ under "ESPR", the company has never paid dividends, and it issued **$280 million** in convertible notes in **2020**, partially exchanged in **2021** - The company's common stock trades on the NASDAQ Global Select Market under the symbol "**ESPR**"[389](index=389&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future[394](index=394&type=chunk) - In November **2020**, the company issued **$280 million** in 4.00% Convertible Senior Subordinated Notes due **2025**[396](index=396&type=chunk) - In October **2021**, the company exchanged **$15.0 million** of its convertible notes for **1,094,848 shares** of common stock[403](index=403&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=75&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Esperion's net loss decreased to **$233.7 million** in **2022**, driven by reduced SG&A expenses, while net product sales increased to **$55.9 million**, and the company believes its **$166.9 million** cash position and future revenues are sufficient to fund operations [Results of Operations](index=81&type=section&id=Results%20of%20Operations) Esperion's net loss improved to **$233.7 million** in **2022**, primarily due to a **$75.9 million** decrease in SG&A expenses, despite increased R&D costs and a decline in collaboration revenue Results of Operations Comparison (Years Ended December 31) | (in thousands) | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | **Product sales, net** | $55,863 | $40,047 | $15,816 | | **Collaboration revenue** | $19,612 | $38,400 | $(18,788) | | **Cost of goods sold** | $26,967 | $14,217 | $12,750 | | **Research and development** | $118,927 | $105,975 | $12,952 | | **Selling, general and administrative** | $109,082 | $184,985 | $(75,903) | | **Loss from operations** | $(179,501) | $(226,730) | $47,229 | | **Net loss** | **$(233,659)** | **$(269,108)** | **$35,449** | - The **$75.9 million** decrease in SG&A expenses was primarily due to lower compensation costs from a Q4 **2021** reduction in force and a **$13.3 million** one-time legal settlement charge in **2021**[448](index=448&type=chunk) - R&D expenses increased by **$12.9 million**, mainly due to increased costs as the CVOT reached **100%** MACE accumulations and entered close-out activities[447](index=447&type=chunk) [Liquidity and Capital Resources](index=82&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, **2022**, Esperion held **$166.9 million** in cash and investments, with net cash used in operating activities decreasing to **$174.8 million**, supported by **$90.8 million** from its ATM program and partially offset by a **$50 million** RIPA payment - As of December 31, **2022**, the company had **$166.9 million** in cash, cash equivalents, and available-for-sale investments[452](index=452&type=chunk) Summary of Cash Flows (Years Ended December 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(174,827) | $(263,809) | | Net cash provided by (used in) investing activities | $8,104 | $(50,484) | | Net cash provided by financing activities | $32,606 | $268,223 | - During **2022**, the company raised approximately **$90.8 million** in net proceeds from its "at-the-market" (ATM) stock offering program[451](index=451&type=chunk)[459](index=459&type=chunk) - In November **2022**, the company made a one-time **$50 million** partial call payment from restricted cash to amend its Revenue Interest Purchase Agreement (RIPA) with Oberland[458](index=458&type=chunk)[462](index=462&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures about Market Risk](index=85&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) Esperion's primary market risk is interest rate fluctuations on its **$166.9 million** in short-term investments, considered immaterial, while also facing unhedged foreign currency risk from global contracts - The company's primary market risk is interest rate fluctuations on its **$166.9 million** in cash, cash equivalents, and investments, but this risk is considered immaterial due to the short-term nature of the investments[468](index=468&type=chunk) - The Convertible Notes have a fixed interest rate of **4.0%**, so there is no direct financial statement risk from changes in interest rates[472](index=472&type=chunk) - The company is exposed to foreign currency fluctuations through its global contracts with CROs and investigational sites but does not hedge this risk[469](index=469&type=chunk) [Item 9A. Controls and Procedures](index=87&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that both disclosure controls and internal control over financial reporting were effective as of December 31, **2022**, with no material changes during the fourth quarter - Management concluded that the company's disclosure controls and procedures were effective as of December 31, **2022**[476](index=476&type=chunk) - Based on the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, **2022**[479](index=479&type=chunk) Part III [Items 10-14](index=89&type=section&id=Items%2010-14) Information required for Items 10 through 14, covering Directors, Executive Officers, Corporate Governance, Executive Compensation, Security Ownership, Certain Relationships and Related Transactions, and Principal Accounting Fees and Services, is incorporated by reference from the company's definitive Proxy Statement for the **2023** Annual Meeting of Shareholders - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the registrant's **2023** Proxy Statement[485](index=485&type=chunk)[486](index=486&type=chunk)[487](index=487&type=chunk) Part IV [Item 15. Exhibits and Financial Statement Schedules](index=90&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of the financial statements and a comprehensive list of all exhibits filed as part of the Annual Report on Form 10-K, including corporate governance documents, material contracts, and certifications - This item lists the financial statements and schedules filed with the report[492](index=492&type=chunk) - An index of all exhibits, including material contracts and certifications, is provided and incorporated by reference[493](index=493&type=chunk)[496](index=496&type=chunk) Financial Statements [Report of Independent Registered Public Accounting Firm](index=96&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) Ernst & Young LLP issued an unqualified opinion on Esperion's financial statements, identifying the valuation of the revenue interest liability as a critical audit matter due to complex future revenue projections - The auditor, Ernst & Young LLP, provided an unqualified opinion on the financial statements[511](index=511&type=chunk) - A Critical Audit Matter was identified related to the valuation of the revenue interest liability, due to the significant estimation uncertainty in forecasting future net sales to determine the effective interest rate[515](index=515&type=chunk)[517](index=517&type=chunk) [Financial Statements Data](index=98&type=section&id=Financial%20Statements%20Data) Esperion's total assets decreased to **$247.9 million** in **2022**, while total liabilities remained stable, and the company reported a net loss of **$233.7 million**, with an accumulated deficit growing to **$1.34 billion** Balance Sheet Highlights (as of Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $124,775 | $208,892 | | Total current assets | $246,683 | $328,972 | | Total assets | $247,939 | $381,590 | | Total current liabilities | $92,308 | $73,352 | | Total liabilities | $571,717 | $578,534 | | Accumulated deficit | $(1,340,036) | $(1,106,377) | | Total stockholders' deficit | $(323,778) | $(196,944) | Statement of Operations Highlights (Year Ended Dec 31) | (in thousands) | 2022 | 2021 | | :--- | :--- | :--- | | Total Revenues | $75,475 | $78,447 | | Total operating expenses | $254,976 | $305,177 | | Loss from operations | $(179,501) | $(226,730) | | Net loss | $(233,659) | $(269,108) | | Net loss per common share | $(3.52) | $(9.31) | [Notes to Financial Statements](index=102&type=section&id=Notes%20to%20Financial%20Statements) The notes detail accounting policies, including revenue recognition and revenue interest liability valuation, describe collaboration agreements, outline **$265.0 million** in convertible notes, and report **$950.8 million** in federal net operating loss carryforwards as of year-end **2022** - The company's collaboration agreements with DSE, Otsuka, and DS involve upfront payments, potential regulatory and sales milestones, and tiered royalties on net sales in their respective territories[580](index=580&type=chunk)[586](index=586&type=chunk)[590](index=590&type=chunk) - The Revenue Interest Purchase Agreement (RIPA) liability was **$243.6 million** as of Dec 31, **2022**. The company made a **$50 million** partial call payment in Nov **2022**, reducing the total cumulative purchaser payments required[621](index=621&type=chunk)[623](index=623&type=chunk) - As of Dec 31, **2022**, the company had **$265.0 million** in principal amount of convertible notes outstanding, with a net carrying amount of **$259.9 million**[643](index=643&type=chunk) - The company had federal Net Operating Loss (NOL) carryforwards of approximately **$950.8 million** as of Dec 31, **2022**, though their use is subject to limitations due to past ownership changes[683](index=683&type=chunk)[685](index=685&type=chunk)

Call Start: 08:00 January 1, 0000 8:39 AM ET Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q3 2022 Earnings Conference Call November 1, 2022 08:00 ET Company Participants Tiffany Aldrich - Associate Director, Corporate Communications Sheldon Koenig - President & Chief Executive Officer JoAnne Foody - Chief Medical Officer Eric Warren - Chief Commercial Officer Benjamin Halladay - Senior Director of Finance Conference Call Participants Mike Yee - Jefferies Serge Belanger - Needham & Company Tom Shrader - BTIG Mi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35986 Esperion Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1870780 (State or other jurisdict ...

WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? ESPERION CORPORATE PRESENTATION August 2022 FORWARD-LOOKNG STATEMENTS & DISCLOSURES This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, restructuring and current and planned operational expenses, future operations, commercial products, clinical development including the timing, designs and pla ...

WHEN DO YOU PLAN TO GET YOUR NEXT CHOLESTEROL TEST? ESPERION Q2 2022 EARNINGS PRESENTATION AUGUST 2, 2022 © 2022 Esperion. All Rights Reserved – For investor audience only FORWARD-LOOKNG STATEMENTS & DISCLOSURES This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, future operations, commercial products, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35986 Esperion Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 26-1870780 (State or other jurisdiction o ...

Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q1 2022 Earnings Conference Call May 3, 2022 8:00 AM ET Company Participants Tiffany Aldrich - Senior Manager, Corporate Communications Sheldon Koenig - President and Chief Executive Officer Joanne Foody - Chief Medical Officer Eric Warren - Chief Commercial Officer BJ Swartz - Chief Strategy Officer Conference Call Participants Serge Belanger - Needham Jason Butler - JMP Securities Jessica Fye - JPMorgan Jeff Hung - Morgan Stanley Joseph Thome - Cowen Paul Choi - G ...

PART I — FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Esperion Therapeutics, Inc.'s unaudited condensed interim financial statements for Q1 2022, covering balance sheets, operations, equity changes, cash flows, and detailed accounting notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$342.9 million** as of March 31, 2022, from **$381.6 million** at year-end 2021, while total liabilities increased, widening the stockholders' deficit to **$(249.0) million** Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $150,364 | $208,892 | | Total Assets | $342,853 | $381,590 | | Total Liabilities | $591,893 | $578,534 | | Total stockholders' deficit | $(249,040) | $(196,944) | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$56.7 million** or **($0.93) per share** in Q1 2022, a significant improvement from **$90.9 million** or **($3.50) per share** in Q1 2021, driven by increased revenues and reduced operating expenses Q1 Statement of Operations (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Product sales, net | $13,354 | $6,350 | | Collaboration revenue | $5,482 | $1,628 | | **Total Revenues** | **$18,836** | **$7,978** | | Total operating expenses | $61,825 | $90,802 | | Loss from operations | $(42,989) | $(82,824) | | **Net loss** | **$(56,731)** | **$(90,935)** | | Net loss per share | $(0.93) | $(3.50) | [Condensed Statements of Stockholders' Deficit](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders'%20Deficit) The total stockholders' deficit widened to **$(249.0) million** as of March 31, 2022, primarily due to the **$56.7 million** net loss incurred during the quarter - The stockholders' deficit widened to **$(249.0) million** at the end of Q1 2022, primarily due to the net loss of **$56.7 million** for the period[16](index=16&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly improved to **$39.0 million** in Q1 2022 from **$89.1 million** in Q1 2021, with overall cash and equivalents decreasing by **$58.5 million** to **$200.4 million** Cash Flow Summary (in thousands) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,990) | $(89,068) | | Net cash used in investing activities | $(18,102) | $0 | | Net cash (used in) provided by financing activities | $(1,436) | $2,045 | | **Net decrease in cash and cash equivalents** | **$(58,528)** | **$(87,023)** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) These notes provide detailed information on significant accounting policies, collaboration agreements, debt instruments, and other material financial items supporting the condensed financial statements - The company recognizes revenue from product sales (NEXLETOL and NEXLIZET) when the customer obtains control, net of variable consideration like rebates and co-pay assistance[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk) - Collaboration revenue in Q1 2022 of **$5.3 million** was primarily from royalty revenue and sales of bulk tablets to partner DSE[55](index=55&type=chunk) - The Revenue Interest Purchase Agreement (RIPA) liability stood at **$266.8 million** as of March 31, 2022, with **$11.0 million** in non-cash interest expense recognized in Q1 2022[87](index=87&type=chunk)[90](index=90&type=chunk)[93](index=93&type=chunk) - The company has **$265.0 million** in principal of 4.0% convertible notes due 2025, with a net carrying amount of **$258.7 million** as of March 31, 2022[94](index=94&type=chunk)[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes the company's Q1 2022 financial performance and condition, covering business overview, COVID-19 impact, operational results, and liquidity, highlighting revenue growth and expense reduction amidst ongoing losses [Overview](index=24&type=section&id=Overview) The company focuses on commercializing its oral, non-statin LDL-C lowering medicines, NEXLETOL and NEXLIZET, while advancing the pivotal CLEAR Outcomes trial with results expected in Q1 2023 - The company's primary focus is on developing and commercializing oral, once-daily, non-statin medicines for patients with elevated LDL-C[138](index=138&type=chunk) - The CLEAR Outcomes trial is expected to report top-line results in the first quarter of 2023, intended to support submissions for a CV risk reduction indication[152](index=152&type=chunk) [The COVID-19 Pandemic](index=26&type=section&id=The%20COVID-19%20Pandemic) The COVID-19 pandemic has adversely impacted commercialization efforts by limiting sales access to physicians, leading to a **40%** corporate workforce reduction in October 2021 to align cost structure - The pandemic has adversely affected commercialization efforts due to limited in-person access for sales personnel to physicians, impacting new patient starts and treatment volume[159](index=159&type=chunk) - To align its operational and expense structure with business realities, the company executed a corporate workforce reduction of approximately **40%** in October 2021[160](index=160&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Q1 2022 saw net product sales increase by **$7.0 million** and collaboration revenue grow by **$3.9 million**, while R&D expenses decreased by **$3.7 million** and SG&A expenses significantly dropped by **$30.7 million** due to cost savings and a prior-year legal settlement Comparison of Results for the Three Months Ended March 31 (in millions) | Item | 2022 | 2021 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Product sales, net | $13.4 | $6.4 | $7.0 | Prescription growth of NEXLETOL and NEXLIZET | | Collaboration revenue | $5.5 | $1.6 | $3.9 | Increased product sales to partners and higher royalty revenue | | R&D Expenses | $24.3 | $28.0 | $(3.7) | Reduction in alternative supply manufacturing and compensation costs | | SG&A Expenses | $30.4 | $61.1 | $(30.7) | Decreased compensation costs from workforce reduction and a $13.3M legal settlement charge in 2021 | [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2022, the company held **$268.5 million** in cash, equivalents, and investments, deemed sufficient to fund operations beyond the CLEAR Outcomes CVOT readout, with net cash used in operating activities significantly decreasing to **$39.0 million** in Q1 2022 - The company held **$268.5 million** in cash, cash equivalents, and investments as of March 31, 2022, including **$50 million** in restricted cash[187](index=187&type=chunk) - Management anticipates that current cash resources are sufficient to complete the CLEAR Outcomes CVOT and fund operations for the foreseeable future beyond the trial's read-out[186](index=186&type=chunk) Cash Flow Activity (in thousands) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,990) | $(89,068) | | Net cash used in investing activities | $(18,102) | $0 | | Net cash (used in) provided by financing activities | $(1,436) | $2,045 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) There have been no material changes to the company's market risk disclosures since its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 - There were no material changes to the company's quantitative and qualitative disclosures about market risk from the 2021 Form 10-K[204](index=204&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal control over financial reporting during the quarter - Management concluded that as of March 31, 2022, the company's disclosure controls and procedures were effective[206](index=206&type=chunk) - No changes occurred during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[207](index=207&type=chunk) PART II — OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) Information regarding legal proceedings, including a settled class action lawsuit, is incorporated by reference from Note 5 to the condensed financial statements - Information regarding legal proceedings is incorporated by reference from Note 5 to the condensed financial statements, which discusses a settled class action lawsuit[209](index=209&type=chunk)[68](index=68&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) There have been no significant changes to the risk factors previously disclosed in the company's 2021 Annual Report on Form 10-K - There have been no significant changes from the risk factors disclosed in the company's 2021 Annual Report on Form 10-K[211](index=211&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the Quarterly Report on Form 10-Q, including an employment agreement and Sarbanes-Oxley Act certifications - The report includes several exhibits, such as an employment agreement with Eric Warren and certifications required under Sections 302 and 906 of the Sarbanes-Oxley Act[214](index=214&type=chunk)[215](index=215&type=chunk)

Financial Data and Key Metrics Changes - US net product revenue for Q4 2021 was $12.2 million, up 12% from Q3 2021, and $40 million for the full year, representing over 200% growth compared to the prior year [7][13] - R&D expenses for Q4 totaled approximately $28 million, slightly up from $25 million in Q3, while full year 2021 R&D expenses were $106 million, a 28% decrease year-over-year [14] - SG&A expenses for Q4 were approximately $38 million, a 2% decrease from Q3, and full year SG&A expenses were $185 million, down 7% year-over-year [14][15] Business Line Data and Key Metrics Changes - Sequential demand for medicines grew 9% in Q4 2021, driven by enhanced product positioning and refined patient support programs initiated in 2021 [7] - The company established a new hybrid commercial model, reducing its commercial footprint to a core sales team of 80 territories, generating $80 million in annualized cost savings [6][7] Market Data and Key Metrics Changes - The company reported that commercial access for NEXLIZET and NEXLETOL is approximately 90%, with Medicare access at 60% [29] - The partnership with Daiichi-Sankyo accelerated the commercial launch in Germany and expanded into the UK and Australia, amassing over 45,000 patients on therapy through December 2021 [10] Company Strategy and Development Direction - The major focus for 2022 is to successfully close out the pivotal CLEAR Outcomes trial, which evaluates the ability of bempedoic acid to reduce adverse cardiovascular events [9][12] - The company aims to drive commercial growth of NEXLETOL and NEXLIZET while preparing for several milestones, including the anticipated top line readout of the CLEAR Outcomes trial in Q1 2023 [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering consistent growth leading up to the CLEAR Outcomes trial results, with cash runway extending beyond this milestone [8][15] - The management highlighted the increased urgency for cardiovascular health due to the COVID-19 pandemic, which has worsened cardiovascular disease rates globally [11][17] Other Important Information - The company has approximately $309 million in cash as of December 31, 2021, positioning it well to execute its strategy [15] - The CLEAR Outcomes trial is one of the largest outcomes trials of non-statin therapies, with 14,000 patients enrolled [9] Q&A Session Summary Question: Can you discuss the importance of getting the label versus just the top line data? - Management indicated that obtaining data is crucial for engaging with payers, and while the label is important, the data will help minimize prior authorization challenges [21][22] Question: What are the key focus areas for increasing access ahead of the CLEAR Outcomes data? - Management noted that they have good access for their products and are actively working to streamline prior authorizations while also educating physicians on documentation requirements [29][30] Question: Can you provide insights on the prior authorization process? - Management explained that prior authorizations are required for all prescriptions, and they have a support program in place to assist physicians in completing these efficiently [52][53] Question: How is the company managing the hybrid business model post-restructuring? - Management reported that the hybrid model has been effective, allowing for flexibility in promotion strategies and maintaining consistent growth despite workforce reductions [36][37] Question: What is the expected timeline for reporting top line data from the CLEAR Outcomes trial? - Management anticipates closing out operations for the study before achieving the final events, with a database lock expected by the end of the year and top line results communicated in Q1 2023 [57][58]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35986 Esperion Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 26-1870780 (State or Other Jurisdi ...