Esperion(ESPR)

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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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Esperion(ESPR) - 2020 Q3 - Quarterly Report
2020-11-02 22:21
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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | --- | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------|- ...
Esperion(ESPR) - 2020 Q2 - Quarterly Report
2020-08-10 21:16
Table of Contents 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, 2020 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 ot ...
Esperion(ESPR) - 2020 Q1 - Quarterly Report
2020-05-06 21:26
```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 the unaudited condensed financial statements for Q1 2020, including balance sheets, operations, equity, and cash flows, with notes on FDA approvals and new collaborations [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2020, total assets decreased to **$179.6 million**, total liabilities increased to **$229.9 million**, resulting in a **$50.2 million** stockholders' deficit from a prior equity position Condensed Balance Sheet Data (in thousands) | Account | March 31, 2020 (Unaudited) | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $149,386 | $166,130 | | Total current assets | $172,629 | $211,714 | | **Total assets** | **$179,642** | **$214,447** | | Total current liabilities | $73,453 | $66,080 | | Revenue interest liability (non-current) | $152,716 | $127,308 | | **Total liabilities** | **$229,888** | **$194,497** | | **Total stockholders' equity (deficit)** | **($50,246)** | **$19,950** | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2020, the company reported a **net loss of $78.2 million** (or **($2.84) per share**), a significant shift from **$87.4 million net income** in Q1 2019, driven by decreased collaboration revenue and increased SG&A for commercial launch Q1 2020 vs. Q1 2019 Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Product sales, net | $858 | $— | | Collaboration revenue | $982 | $145,419 | | **Total Revenues** | **$1,840** | **$145,419** | | Research and development | $34,702 | $46,308 | | Selling, general and administrative | $41,553 | $12,182 | | **Total operating expenses** | **$76,286** | **$58,490** | | **Net income (loss)** | **($78,249)** | **$87,379** | | **Net income (loss) per share - basic** | **($2.84)** | **$3.26** | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity shifted from a **$19.95 million** equity to a **($50.25) million** deficit by March 31, 2020, primarily due to a **$78.2 million** net loss during the quarter - The primary driver for the decrease in stockholders' equity was the **net loss of $78.2 million** for the three months ended March 31, 2020[14](index=14&type=chunk) [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$69.3 million** in Q1 2020, a reversal from **$91.7 million** provided in Q1 2019, with overall cash decreasing by **$16.7 million** despite **$26.0 million** from financing activities Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | ($69,347) | $91,691 | | Net cash provided by investing activities | $26,589 | $45,696 | | Net cash provided by financing activities | $26,014 | $1,669 | | **Net (decrease) increase in cash and cash equivalents** | **($16,744)** | **$139,056** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail FDA approvals and U.S. commercial launch of **NEXLETOL** and **NEXLIZET**, a new **$60 million** **Otsuka** collaboration, and an increased **$161.7 million** revenue interest liability, alongside legal proceedings and accounting policies - The FDA approved **NEXLETOL** on February 21, 2020, and **NEXLIZET** on February 26, 2020, as the first oral, once-daily, non-statin LDL-C lowering medicines approved in the U.S. in nearly **20 years**[21](index=21&type=chunk)[22](index=22&type=chunk) - In April 2020, a collaboration with **Otsuka** for Japan was signed, including a **$60 million** upfront cash payment and eligibility for up to **$450 million** in milestones[24](index=24&type=chunk)[130](index=130&type=chunk) - The revenue interest liability with **Oberland** increased to **$161.7 million** as of March 31, 2020, following an additional **$25.0 million** funding upon **NEXLETOL**'s approval[103](index=103&type=chunk)[109](index=109&type=chunk)[112](index=112&type=chunk) - The ongoing global cardiovascular outcomes trial (CVOT) **CLEAR Outcomes**, fully enrolled with **14,032 patients**, expects results in the second half of 2022[25](index=25&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2020 operational and financial results, focusing on landmark U.S. and European approvals, commercial launch, and the emerging risks from the COVID-19 pandemic [Overview](index=33&type=section&id=Overview) **Esperion** focuses on developing and commercializing non-statin LDL-C medicines, achieving FDA and European approvals for **NEXLETOL**/**NEXLIZET** and launching **NEXLETOL** in the U.S. in Q1 2020 - Received FDA approval for **NEXLETOL** and **NEXLIZET** in February 2020, marking the first oral, once-daily, non-statin LDL-C lowering medicines approved in the U.S. in nearly **20 years** for ASCVD or HeFH patients[138](index=138&type=chunk)[139](index=139&type=chunk)[141](index=141&type=chunk) - The European Commission approved **NILEMDO**™ (bempedoic acid) and **NUSTENDI**™ (bempedoic acid and ezetimibe) in April 2020 for hypercholesterolemia and mixed dyslipidemia[142](index=142&type=chunk) - The **CLEAR Outcomes** CVOT, a global trial with **14,032 patients**, is ongoing and expected to provide data on cardiovascular risk reduction in the second half of 2022[144](index=144&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) Q1 2020 total revenue drastically fell to **$1.8 million** from **$145.4 million** in Q1 2019, with a **$78.2 million** net loss driven by decreased collaboration revenue and increased SG&A for commercialization Comparison of Operating Results (in thousands) | Item | Q1 2020 | Q1 2019 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $1,840 | $145,419 | $(143,579) | | Research and development | $34,702 | $46,308 | $(11,606) | | Selling, general and administrative | $41,553 | $12,182 | $29,371 | | **Net income (loss)** | **$(78,249)** | **$87,379** | **$(165,628)** | - The increase in SG&A expenses was primarily due to costs to support the commercialization of **NEXLETOL** and **NEXLIZET**, including the buildout of a **300-member** customer-facing team[190](index=190&type=chunk) [Liquidity and Capital Resources](index=45&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2020, the company held **$157.3 million** in cash and investments, bolstered by a **$25.0 million** payment from **Oberland** and a subsequent **$60.0 million** from **Otsuka**, deemed sufficient for commercialization - As of March 31, 2020, cash, cash equivalents, and available-for-sale investments totaled **$157.3 million**[196](index=196&type=chunk) - Received **$25.0 million** from the **Oberland** RIPA in March 2020 upon regulatory approval of **NEXLETOL**[201](index=201&type=chunk)[206](index=206&type=chunk) - Received a **$60.0 million** upfront cash payment from the **Otsuka** collaboration agreement in April 2020[195](index=195&type=chunk) - Management estimates that current cash and future proceeds from sales and collaborations are sufficient to fund operations through the commercialization of **NEXLETOL** and **NEXLIZET**[204](index=204&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=51&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its **$157.3 million** cash and investments, alongside unhedged foreign currency risk and revenue interest liability rate variability - The primary market risk is interest rate fluctuations on cash and investments, which totaled approximately **$157.3 million** at March 31, 2020[212](index=212&type=chunk) - The company is subject to unhedged foreign currency exchange rate risk through its contracts with global CROs and investigational sites[214](index=214&type=chunk) - The interest rate on the revenue interest purchase agreement liability may vary depending on the level of forecasted net sales, creating additional market risk[216](index=216&type=chunk) [Item 4. Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2020, having implemented new internal controls for net product sales and inventory processes due to commercial launch - Management concluded that disclosure controls and procedures were effective as of March 31, 2020[219](index=219&type=chunk) - During Q1 2020, new procedures and controls around net product sales and inventory processes were implemented due to the commercial launch of **NEXLETOL** and **NEXLIZET**[220](index=220&type=chunk) [PART II — OTHER INFORMATION](index=54&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company faces ongoing securities class action and stockholder derivative lawsuits, for which it is currently unable to predict the outcome or estimate potential financial loss - A putative class action lawsuit (**Dougherty v. Esperion**) from 2016, alleging securities violations, is ongoing after a dismissal was reversed by the Sixth Circuit Court of Appeals[222](index=222&type=chunk) - A stockholder derivative lawsuit from 2016, alleging breach of fiduciary duties, was dismissed in February 2020, but the plaintiff filed a notice of appeal in March 2020[223](index=223&type=chunk) - The company is unable to predict the outcome or make a meaningful estimate of potential loss for these legal matters[222](index=222&type=chunk)[223](index=223&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, prominently featuring new and significant risks posed by the COVID-19 pandemic, which could materially impact business operations, product launch, and clinical trials - The outbreak of the novel coronavirus (**COVID-19**) is identified as a new, significant risk factor that could materially adversely impact the business, financial condition, and results of operations[228](index=228&type=chunk) - Potential disruptions from **COVID-19** include negative impacts on the commercial launch of **NEXLETOL** and **NEXLIZET**, delays in the ongoing **CLEAR Outcomes** trial, and interruptions to the third-party manufacturing supply chain[230](index=230&type=chunk) - In response to the pandemic, the company's commercial and medical teams have suspended in-person interactions with physicians and are conducting activities virtually[229](index=229&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=56&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the reporting period - None reported[233](index=233&type=chunk) [Item 6. Exhibits](index=56&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and Inline XBRL financial data files - The exhibits filed with the report include officer certifications pursuant to Sarbanes-Oxley Sections **302** and **906**, and Inline XBRL documents[237](index=237&type=chunk) ```