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Esperion(ESPR) - 2022 Q1 - Quarterly Report
2022-05-02 16:00
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)
Esperion(ESPR) - 2021 Q4 - Earnings Call Transcript
2022-02-22 19:12
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]
Esperion(ESPR) - 2021 Q4 - Annual Report
2022-02-21 16:00
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 ...
Esperion(ESPR) - 2021 Q3 - Earnings Call Transcript
2021-11-02 16:03
Esperion Therapeutics, Inc. (NASDAQ:ESPR) Q3 2021 Results Conference Call November 2, 2021 8:00 AM ET Company Participants Ben Church - Investor Relations & Corporate Communications Sheldon Koenig - President & Chief Executive Officer Rick Bartram - Chief Financial Officer Dr. Joanne Foody - Chief Medical Officer Eric Warren - Head of Sales and Marketing Conference Call Participants Michael Yee - Jefferies Joseph Thome - Cowen Serge Belanger - Needham & Company Jason Butler - JMP Securities Judah Frommer - ...
Esperion(ESPR) - 2021 Q3 - Quarterly Report
2021-11-01 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 September 30, 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 jurisdict ...
Esperion(ESPR) - 2021 Q2 - Earnings Call Presentation
2021-08-03 14:56
| --- | --- | --- | |---------------------------------------------------|-------|-------| | | | | | ESPERION Q2 2021 CONFERENCE CALL August 3rd, 2021 | | | | | | | SAFE HARBOR FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the global clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combina ...
Esperion(ESPR) - 2021 Q2 - Quarterly Report
2021-08-02 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, 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 jurisdiction o ...
Esperion(ESPR) - 2021 Q1 - Quarterly Report
2021-05-03 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, 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 jurisdiction ...
Esperion(ESPR) - 2020 Q3 - Earnings Call Presentation
2021-02-24 14:34
Business Highlights - Esperion is focused on addressing bad cholesterol, with 35 million patients in the U S, Japan, and the EU considered statin intolerant[4] - Statin intolerance impacts up to 20% of individuals treated with a statin[4, 5] - Over 25,000 patients are taking Esperion's medicines[5] - The CLEAR Outcomes trial, focusing on statin-intolerant patients, has enrolled over 14,000 patients[5] Operational Overview - Over 8,600 doctors are writing at least one prescription for Esperion's medicines[7] - More than 3,300 patients are taking Esperion's medicines every week[7] - Over 420,000 seven-day starter packs have been requested to initiate patients on Esperion's medicines[7] - New-to-brand statin prescriptions are down 9% year-to-date in 2021 compared to 2020 due to COVID-19 impacts[7] Financial Update - U S Net Product Sales increased 146% quarter over quarter[9] - First Royalty Revenue from DSE was $8.2 million in Q4[9] - Ex-U S Royalty Revenues were $3.3 million[9] - Collaboration Milestones were greater than $1 million[9] - The company's cash balance was $305 million at the end of FY 2020[11, 13] - FY 2021 OpEx guidance is $320 - $340 million[13] - FY 2021 R&D guidance is $120 - $130 million[13] - FY 2021 SG&A guidance is $200 - $210 million[13]
Esperion(ESPR) - 2020 Q4 - Annual Report
2021-02-22 16:00
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