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Esperion(ESPR) - 2023 Q1 - Earnings Call Transcript
2023-05-09 18:32
Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q1 2023 Earnings Conference Call May 9, 2023 8:00 AM ET Company Participants Tiffany Aldrich - Associate Director, Corporate Communications Sheldon Koenig - President and Chief Executive Officer Eric Warren - Chief Commercial Officer Benjamin Halladay - Chief Financial Officer JoAnne Foody - Chief Medical Officer Betty Swartz - Chief Strategy Officer Conference Call Participants Dennis Ding - Jefferies Serge Belanger - Needham Jessica Fye - JPMorgan Jason Zemansky - ...
Esperion(ESPR) - 2023 Q1 - Quarterly Report
2023-05-08 16:00
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 March 31, 2023 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) (State or other jurisdiction of incorporation or ...
Esperion(ESPR) - 2022 Q4 - Earnings Call Transcript
2023-02-21 19:10
Financial Data and Key Metrics Changes - The company reported U.S. net product revenue of $15 million for Q4 2022, a 23% increase year-over-year, and $55.9 million for the full year 2022, up approximately 40% year-over-year [4][11] - Total revenue for Q4 2022 was $18.8 million, a 22% increase year-over-year, while total revenue for the full year 2022 decreased by 4% to $75.5 million due to a one-time milestone payment [11] - Cash, cash equivalents, and investment securities totaled $166.9 million as of December 31, 2022, down from $309.3 million a year earlier [6] Business Line Data and Key Metrics Changes - Royalty revenue for Q4 2022 was $2.3 million, up 188% year-over-year, and $6.5 million for the full year, an 81% increase year-over-year [6] - Combined royalty and partner revenue for Q4 2022 was $3.9 million, a 22% increase year-over-year, but decreased by 49% for the full year to $19.6 million due to a prior year milestone payment [7] Market Data and Key Metrics Changes - The partner Daiichi Sankyo reported strong growth for NILEMDO and NUSTENDI in Europe, with over 82,000 patients in November 2022 [5] Company Strategy and Development Direction - The company is focused on expanding patient access and improving prior authorization criteria while preparing for regulatory filings with the FDA and EMA in the first half of 2023 [1] - Plans are underway to scale the commercial organization and transition to a broader promotional approach following the anticipated positive results from the CLEAR Outcomes trial [106] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive impact of the CLEAR Outcomes trial on clinical management for patients at risk for cardiovascular disease [116] - The company is optimistic about achieving broader patient access and reimbursement improvements following recent formulary additions [109] Other Important Information - The company has reduced SG&A expenses by 41% year-over-year, reflecting cost management strategies implemented in 2021 [113] - The upcoming presentation of the CLEAR Outcomes trial results is expected to be a pivotal moment for the company, with significant implications for future growth [106] Q&A Session Summary Question: What is the divergence of the meaning of clinically meaningful between the investment community and the medical communities? - Management emphasized that clinically meaningful results are those that improve patient health and influence prescribing practices, highlighting the differentiation of their drugs [121] Question: How familiar are prescribing physicians with the benefits of hsCRP and glucose control? - Management acknowledged that awareness is lower than desired but noted that exposure to their current profile has had a favorable impact, with significant changes expected following the CVOT data release [80] Question: How is the company thinking about spending on sales moving forward? - Management indicated that while they have managed cash prudently, they are considering ramping up sales efforts in anticipation of increased demand following the CLEAR Outcomes data [64]
Esperion(ESPR) - 2022 Q4 - Annual Report
2023-02-20 16:00
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)
Esperion(ESPR) - 2022 Q3 - Earnings Call Transcript
2022-11-01 18:03
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 ...
Esperion(ESPR) - 2022 Q3 - Quarterly Report
2022-10-31 16:00
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 ...
Esperion Therapeutics (ESPR) Investor Presentation - Slideshow
2022-09-15 17:33
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 ...
Esperion(ESPR) - 2022 Q2 - Earnings Call Presentation
2022-08-02 11:54
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, ...
Esperion(ESPR) - 2022 Q2 - Quarterly Report
2022-08-01 16:00
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(ESPR) - 2022 Q1 - Earnings Call Transcript
2022-05-03 18:08
Financial Data and Key Metrics Changes - U.S. net product revenue for Q1 2022 was $13.4 million, up approximately 109% year-over-year [19] - Total revenue for Q1 2022 was $18.8 million, an increase of approximately 135% year-over-year compared to $8 million in Q1 2021 [19] - R&D expense for Q1 2022 was $24.3 million, a decrease of 13% year-over-year [21] - SG&A expense was $30.4 million for Q1 2022, a decrease of 50% year-over-year [21] - Cash and cash equivalents totaled $268.5 million as of March 31, 2022, down from $309.3 million on December 31, 2021 [22] Business Line Data and Key Metrics Changes - Year-over-year demand for NEXLETOL and NEXLIZET grew 56.7% in Q1 2022 [8] - Royalty revenue for Q1 2022 was $1.1 million, up 83% year-over-year [19] - Combined royalty and partner revenue of $5.5 million for Q1 2022 grew approximately 244% year-over-year [19] Market Data and Key Metrics Changes - The European market has shown significant traction, with partners treating at least 52,000 patients through Q1 2022 [9] - The lipid market is projected to exceed $11 billion in annual worldwide revenue by 2026 [11] Company Strategy and Development Direction - The company aims to become an innovative cardiometabolic leader by focusing on the growth of commercial products and advancing the CLEAR Outcomes trial [7] - Esperion is committed to providing oral therapies to address cardiovascular risk and has announced support for a collaborative study to study NEXLIZET's effects post-heart attack [12] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of addressing the high percentage of patients not achieving LDL cholesterol goals, with 70% of patients not at guideline-recommended levels [11] - The company expects to reach 100% MACE accumulation in the CLEAR Outcomes trial by the end of 2022, with top-line data expected in Q1 2023 [10][17] Other Important Information - The company filed a $400 million shelf registration statement to preserve financial flexibility [24] - Esperion views its stock price as depressed and is focused on maximizing shareholder value [24] Q&A Session Summary Question: Can you comment on the U.S. sales trajectory and the impact of the pandemic? - Management noted a 6.5% volume increase and expressed confidence in continued growth despite pandemic impacts [27][28] Question: What is the status of the contract sales force effort? - The contract sales force is in pilot form, targeting new physicians and showing encouraging results [30][31] Question: Can you provide an update on the CLEAR Outcomes study? - The study is progressing well, with nearly 95% of events adjudicated and end-of-study visits ahead of schedule [35][40] Question: How are NEXLETOL and NEXLIZET being utilized among patients? - The primary population includes patients on maximally tolerated statins who require additional LDL-C reduction [41] Question: What are the reorder rates for patients on therapy? - Adherence rates are consistent with chronic oral therapies, and the company is implementing programs to improve adherence [56]