ESPR on NASDAQ

Esperion Therapeutics

American pharmaceutical company

Esperion Therapeutics, Inc. is a publicly traded American pharmaceutical company focused on the development of bempedoic acid, an orally available small molecule designed to lower elevated levels of LDL-C. The company is headquartered in Ann Arbor, Michigan.3 Its shares trade on NASDAQ under the symbol ESPR.1 Wikipedia text CC BY-SA 4.0

Price unavailable

Last updated Oct 21, 2026.

Overview

Jan 1, 2008Founded1

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  • TickerESPR on NASDAQ1
  • Industrypharmaceutical industry1
  • HeadquartersAnn Arbor1
  • Websitewww.esperion.com
  • Legal formDelaware corporation1
  • Incorporated inDE5
  • Business address3891 Ranchero Drive, Suite 150, Ann Arbor, Mi 481085
  • Filer categoryAccelerated filer, Smaller reporting company5
  • LEI549300OFU56UKEWVUS924
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressCORPORATION TRUST CENTER 1209 ORANGE ST, 19801 Wilmington, United States4
  • Registered withDivision of Corporations, Department of State, 44933494

Esperion Therapeutics, Inc. is a publicly traded American pharmaceutical company focused on the development of bempedoic acid, an orally available small molecule designed to lower elevated levels of LDL-C. The company is headquartered in Ann Arbor, Michigan.3

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

15.0%Operating margin7
-5.6%Net margin7
21.3%Revenue growth, 20257
-$13.1MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Selling, general and admin41¢$165.8M
  • Other costs58¢$235.5M
  • Income tax0¢$1.8M

Out of $403.1M in revenue.7 The company lost money this year.

Financial statements

Revenue89107$403.1M in 2025+172% since 2019
0$200.0M$400.0M$600.0M2019: $148.4M$148.4M20192020: $227.5M$227.5M2020+53%2021: $78.4M$78.4M2021−66%2022: $75.5M$75.5M2022−4%2023: $116.3M$116.3M2023+54%2024: $332.3M$332.3M2024+186%2025: $403.1M$403.1M2025+21%
Operating income89107$60.3M in 2025
-$300.0M-$200.0M-$100.0M0$100.0M2019: -$93.1M-$93.1M20192020: -$121.4M-$121.4M2020+30%2021: -$226.7M-$226.7M2021+87%2022: -$179.5M-$179.5M2022−21%2023: -$155.6M-$155.6M2023−13%2024: $54.4M$54.4M20242025: $60.3M$60.3M2025+11%
Net income89107-$22.7M in 2025−77% since 2019
-$300.0M-$200.0M-$100.0M02019: -$97.2M-$97.2M20192020: -$143.6M-$143.6M2020+48%2021: -$269.1M-$269.1M2021+87%2022: -$233.7M-$233.7M2022−13%2023: -$209.2M-$209.2M2023−10%2024: -$51.7M-$51.7M2024−75%2025: -$22.7M-$22.7M2025−56%
Fiscal year2019202020212022202320242025
Revenue$148.4M8$227.5M8$78.4M9$75.5M10$116.3M7$332.3M7$403.1M7
Selling, general and admin$65.9M8$199.6M8$185.0M9$109.1M10$142.5M7$163.1M7$165.8M7
Operating expenses$305.2M9$255.0M10$271.9M7$277.9M7$342.9M7
Operating income-$93.1M8-$121.4M8-$226.7M9-$179.5M10-$155.6M7$54.4M7$60.3M7
Interest$8.1M8$22.7M8$46.4M9$56.8M14$59.0M14
Income before tax-$209.2M7-$51.7M7-$20.8M7
Income tax$08$08$09$014$07$07$1.8M7
Net income-$97.2M8-$143.6M8-$269.1M9-$233.7M10-$209.2M7-$51.7M7-$22.7M7
Earnings per share-$3.598-$5.238-$9.319-$3.5210-$2.037-$0.287-$0.117
Earnings per share (diluted)-$3.598-$5.238-$9.319-$3.5210-$2.037-$0.287-$0.117
Shares (weighted, basic)28.9M shares966.4M shares10103.1M shares7187.2M shares7207.9M shares7
Shares (weighted, diluted)28.9M shares966.4M shares10103.1M shares7187.2M shares7207.9M shares7

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Corporate structure

Esperion Therapeutics sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Esperion Therapeutics

  • Goldman Sachs Filed SCHEDULE 13G on Esperion Therapeutics, latest Aug 13, 2026
  • VANGUARD CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Esperion Therapeutics, latest Jul 31, 2026
  • WASATCH ADVISORS LP Filed SCHEDULE 13G/A on Esperion Therapeutics, latest Jul 14, 2026 (7 filings since Feb 11, 2022)
  • GLAZER CAPITAL, LLC Filed SCHEDULE 13G on Esperion Therapeutics, latest Jun 8, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Esperion Therapeutics, latest Mar 26, 2026 (7 filings since Feb 10, 2022)
  • Two Seas Capital LP Filed SCHEDULE 13G/A on Esperion Therapeutics, latest Nov 14, 2025 (5 filings since Oct 5, 2023)
  • BB Biotech Filed SCHEDULE 13G/A on Esperion Therapeutics, latest Mar 10, 2025 (6 filings since Feb 11, 2022)
  • BlackRock Filed SC 13G on Esperion Therapeutics, latest Nov 8, 2024 (5 filings since Jan 10, 2022)
  • MILLENNIUM MANAGEMENT LLC Filed SC 13G/A on Esperion Therapeutics, latest Oct 17, 2024 (6 filings since Jan 20, 2023)
  • CVI Investments, Inc. Filed SC 13G/A on Esperion Therapeutics, latest Feb 14, 2024 (4 filings since Dec 10, 2021)
  • Deep Track Capital, LP Filed SC 13G/A on Esperion Therapeutics, latest Feb 14, 2024 (2 filings since Dec 9, 2021)
  • Point72 Asset Management, L.P. Filed SC 13G/A on Esperion Therapeutics, latest Feb 14, 2024 (4 filings since Aug 23, 2022)
  • Esperion Therapeutics Wilmington, Delaware, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Esperion Therapeutics reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$2.5M7 Dec 31, 2025$2.3M7 Dec 31, 2024+8.1%
Accumulated depreciation$2.2M7 Dec 31, 2025$2.1M7 Dec 31, 2024+5.1%
Property and equipment, net$338.0K7 Dec 31, 2025$254.0K7 Dec 31, 2024+33.1%
Operating-lease assets (leased space)$2.9M7 Dec 31, 2025$5.5M7 Dec 31, 2024−47.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$167.9M7 Dec 31, 2025$144.8M7 Dec 31, 2024+16.0%
Debt securities available for sale$135.6M7 Dec 31, 2025$107.3M7 Dec 31, 2024+26.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$105.1M7 Dec 31, 2025$94.5M7 Dec 31, 2024+11.3%
Raw materials$98.8M7 Dec 31, 2025$84.6M7 Dec 31, 2024+16.8%
Work in process$4.5M7 Dec 31, 2025$3.7M7 Dec 31, 2024+22.2%
Finished goods$1.8M7 Dec 31, 2025$6.2M7 Dec 31, 2024−70.6%

Properties, in its own words

Our corporate headquarters are located in Ann Arbor, Michigan where we lease and occupy approximately 11,500 square feet of office space. We believe our current facilities will be sufficient to meet our needs until expiration.

Item 2 of the 10-K filed Mar 10, 2026.17

The story

The first Esperion

The first Esperion was founded in 1998 by Dr. Roger Newton to focus on the in-licensing and development of drugs to modulate HDL cholesterol (HDL-c).

Pfizer acquired the original Esperion in February 2004 for US$1,300,000,000. It's believed this was a defensive move by Pfizer to prevent ETC-216 (apoA-1 Milano, Esperion's lead drug candidate) from falling into competitors' hands. ETC-216 increased the levels of ApoA-1, the major protein in HDL cholesterol (HDL-c), the so-called "good cholesterol". It was believed that raising the levels of ApoA-1 (or HDL-c) in the body would reduce cardiovascular disease risk. At the time, Pfizer was the leader in developing a promising new class of drugs known as CETP inhibitors (CETPi). These drugs also raised HDL-c. However, almost 3 years later, in late 2006, Pfizer's CETPi drug (torcetrapib) failed in the final stages of clinical development. Pfizer terminated the development program for torcetrapib and reportedly ended all other cardiovascular drug development programs, including drug development programs for ETC-216 and the other programs acquired from Esperion.

The second Esperion

In May 2008, Dr. Roger Newton, negotiated with Pfizer to acquire the patent estates for two drug candidates (including ETC-1002/bempedoic acid/Nexletol) discovered by the original Esperion team and raised capital from four venture capital firms to found the "new" Esperion. This led to a second independent period for the company, focused almost exclusively on the development of ETC-1002, a drug which lowers the levels of LDL-cholesterol (LDL-c) the so-called "bad cholesterol" and targeted for patients that could not - or would not - take statins (statins are the standard-of-care medicine for lowering levels of bad cholesterol).

In June 2013, Esperion became a public company again through an initial public offering. As of April 2014, Esperion is traded on NASDAQ under the symbol "ESPR".

From Wikipedia’s article on Esperion Therapeutics, shared under CC BY-SA 4.0.6

Leadership

Who has led Esperion Therapeutics, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (27)

Products and brands

The company's main products are NEXLIZET (bempedoic acid and ezetimibe) and NEXLETOL (bempedoic acid), the first approved oral, once-daily, non-statin LDL-Cholesterol (LDL-C) lowering combination medicine that is now available in U.S. pharmacies. Further products include NILEMDO (also a ATP Citrate Lyase inhibitor like NEXLETOL) and NUSTENDI (bempedoic acid and ezetimibe like NEXLIZET).

From Wikipedia’s article on Esperion Therapeutics, shared under CC BY-SA 4.0.6

Former names

  • HDL THERAPEUTICS INCMay 7, 2008 to May 7, 20085

Timeline

  1. Jul 13, 20268-K Entered a material agreement; Ended a material agreement; Completed an acquisition or sale50
  2. Jul 8, 20268-K Shareholder vote51
  3. Jun 18, 20268-K Financial statements and exhibits52
  4. Jun 16, 20268-K Other events53
  5. Jun 9, 20268-K Other events54
  6. Jun 1, 20268-K Executive or director change; Shareholder vote55
  7. May 1, 20268-K Entered a material agreement; Regulation FD disclosure56
  8. Apr 2, 20268-K Entered a material agreement; Completed an acquisition or sale; New debt or obligation57
  9. Mar 10, 20268-K Results of operations58
  10. Mar 3, 20268-K Entered a material agreement; Regulation FD disclosure59
  11. Jan 12, 20268-K Results of operations60
  12. Nov 6, 20258-K Results of operations61
  13. May 18, 2021New chief executive Sheldon L. Koenig becomes CEO18
  14. Jun 25, 2013New chief executive Timothy M. Mayleben becomes CEO19
  15. Jan 1, 2008Founded Founded1

Calendar

When it reported results

  1. Mar 10, 2026Reported quarterly or annual results58
  2. Jan 12, 2026Reported quarterly or annual results60
  3. Nov 6, 2025Reported quarterly or annual results61
  4. Aug 11, 2025Reported quarterly or annual results62
  5. Aug 5, 2025Reported quarterly or annual results63
  6. May 6, 2025Reported quarterly or annual results64
  7. Mar 4, 2025Reported quarterly or annual results65
  8. Jan 16, 2025Reported quarterly or annual results66

Drug trials and FDA: recently

  1. Jun 4, 2025Phase 2 trial completed Phase 2 trial of Bempedoic acid in Hypercholesterolemia: primary completion Jun 4, 2025, results posted Jul 17, 2026 (ClinicalTrials.gov NCT05694260).67

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

445 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 71 major events, 164 insider forms, 58 large holders, 133 other. The latest 20:

  1. Aug 13, 2026SCHEDULE 13G EDGAR
  2. Jul 31, 2026SCHEDULE 13G EDGAR
  3. Jul 23, 202615-12G EDGAR
  4. Jul 15, 2026EFFECT EDGAR
  5. Jul 15, 2026EFFECT EDGAR
  6. Jul 15, 2026EFFECT EDGAR
  7. Jul 15, 2026EFFECT EDGAR
  8. Jul 15, 2026EFFECT EDGAR
  9. Jul 15, 2026EFFECT EDGAR
  10. Jul 14, 2026SCHEDULE 13G/A EDGAR
  11. Jul 13, 20264 EDGAR
  12. Jul 13, 20264 EDGAR
  13. Jul 13, 20264 EDGAR
  14. Jul 13, 20264 EDGAR
  15. Jul 13, 20264 EDGAR
  16. Jul 13, 20264 EDGAR
  17. Jul 13, 20264 EDGAR
  18. Jul 13, 20264 EDGAR
  19. Jul 13, 20264 EDGAR
  20. Jul 13, 2026POSASR EDGAR

The 445 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

75 open-market trades by officers, directors and large owners since October 2021: 7 buys and 68 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 17, 2026Looker BenjaminChief Legal OfficerSale11,824$3.16$37.4KForm 4
Jun 17, 2026Koenig Sheldon L.President and CEOSale53,588$3.16$169.3KForm 4
Jun 17, 2026Halladay BenjaminChief Financial OfficerSale10,773$3.16$34.0KForm 4
Mar 17, 2026Looker BenjaminChief Legal OfficerSale5,708$2.70$15.4KForm 4
Mar 17, 2026Koenig Sheldon L.President and CEOSale25,578$2.72$69.6KForm 4
Mar 17, 2026Halladay BenjaminChief Financial OfficerSale6,424$2.71$17.4KForm 4
Jan 20, 2026Looker BenjaminChief Legal OfficerSale1,689$2.88$4.9KForm 4
Dec 17, 2025Koenig Sheldon L.President and CEOSale48,244$3.67$177.1KForm 4
Dec 17, 2025Halladay BenjaminChief Financial OfficerSale7,337$3.67$26.9KForm 4
Dec 17, 2025Looker BenjaminChief Legal OfficerSale6,517$3.67$23.9KForm 4
Oct 17, 2025Looker BenjaminChief Legal OfficerSale1,248$2.62$3.3KForm 4
Sep 17, 2025Halladay BenjaminChief Financial OfficerSale7,046$2.81$19.8KForm 4
Sep 17, 2025Looker BenjaminChief Legal OfficerSale6,267$2.80$17.5KForm 4
Sep 17, 2025Koenig Sheldon L.President and CEOSale28,427$2.79$79.3KForm 4
Jul 17, 2025Looker BenjaminChief Legal OfficerSale1,304$1.13$1.5KForm 4
Jul 17, 2025Halladay BenjaminChief Financial OfficerSale11$1.12$12Form 4
Jun 17, 2025Looker BenjaminChief Legal OfficerSale6,422$1.15$7.4KForm 4
Jun 17, 2025Koenig Sheldon L.President and CEOSale30,474$1.11$33.8KForm 4
Jun 17, 2025Halladay BenjaminChief Financial OfficerSale7,229$1.15$8.3KForm 4
Apr 17, 2025Warren EricChief Commercial OfficerSale108$0.98$106Form 4

All 75 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Sheldon L. Koenig60$770.8K$3.5M84
2025John B. Harlow, Jr.Chief Commercial Officer50$66.9K$2.8M84
2025Benjamin Halladay40$495.8K$1.4M84
2024President and Chief Executive Officer$745.8K$3.2M84
2024Chief Financial Officer$467.3K$1.4M84

SEC filer profile

How Esperion Therapeutics is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGAREsperion Therapeutics, Inc.2
  • CIK0001434868
  • Employer ID (EIN)26-187078017
  • Filer statusAccelerated filer not an emerging growth company; a smaller reporting company; not a shell company17
  • Incorporated inDelaware17
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address3891 Ranchero Drive, Suite 150, Ann Arbor, MI 481082
  • Phone734-887-39032
  • Shares outstanding257,431,942 as of Apr 30, 202613
  • Public float$198.2M as of Jun 30, 202517
  • AuditorErnst & Young LLP, Detroit, Michigan PCAOB ID 42; it also attests to the company’s internal control over financial reporting17
  • On EDGAR sinceMay 7, 20082
  • Filings952 in all: 4 (348), 8-K (177), SC 13G/A (68), 144 (54), 3 (48), 10-Q (39), SC 13G (33), S-8 (18)2
    All 51 form types

    S-8 POS (18), 424B5 (15), DEF 14A (14), 10-K (13), EFFECT (12), DEFA14A (9), SC 13D/A (9), SCHEDULE 13G/A (7), POS AM (6), S-3 (6), ARS (5), CORRESP (5), SCHEDULE 13G (5), UPLOAD (5), PRE 14A (3), SC 13D (3), 8-K/A (2), CT ORDER (2), D (2), D/A (2), S-1/A (2), 144/A (1), 15-12G (1), 25-NSE (1), 424B3 (1), 424B4 (1), 5 (1), 8-A12B (1), CERTNAS (1), DEFM14A (1), DRS (1), DRSLTR (1), FWP (1), NT 10-Q (1), POS462B (1), POSASR (1), PREM14A (1), REGDEX (1), RW (1), S-1 (1), S-1MEF (1), S-3ASR (1), S-3MEF (1)

  • Latest filingsAnnual report (10-K) Mar 10, 2026
    Quarterly report (10-Q) May 8, 2026
    Proxy statement (DEF 14A) Apr 16, 2026
    Latest 8-K (8-K) Jul 13, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par valueESPRNASDAQ Stock Market LLC

From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).17

Risk factors and legal proceedings

The risks Esperion Therapeutics names in Item 1A of its 10-K filed Mar 10, 2026: 65 risks under these headings, as written.17

  • You should consider carefully the following risk factors, together with all of the other information included or incorporated in this Annual Report on Form 10-K. If any of the following risks, either alone or taken together, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our common stock could decline, and stockholders may lose all or part of their investment.
  • Risks Related to our Business and Commercialization
  • Risks Related to Business Development and Commercialization
  • We depend almost entirely on the success of two products, bempedoic acid and the bempedoic acid / ezetimibe combination tablet. There is no assurance that our commercialization efforts in the U.S. and our partner's efforts, including DSE, DS and Otsuka, with respect to either product will be successful or that we will be able to generate revenues at the levels or within the timing we expect or at the levels or within the timing necessary to support our corporate goals.
  • We have limited experience as a commercial company and the marketing and sale of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any future approved drugs may be unsuccessful or less successful than anticipated.
  • The commercialization of the bempedoic acid / ezetimibe combination tablet in the U.S. and Europe and in other territories, depends on the continued availability of ezetimibe.
  • Our reliance on sole source third-party suppliers could harm our ability to commercialize bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any drug candidates that may be approved in the future.
  • Even though we have received marketing approval for bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the U.S. and Europe and other territories in Asia, and even if we receive such approval in other markets, we may still face future development, ongoing regulatory oversight and regulatory difficulties.
  • If the FDA, EMA or other comparable foreign regulatory authorities approve generic or other versions of bempedoic acid or the bempedoic acid / ezetimibe combination tablet, the sales of our approved products could be adversely affected.
  • Relationships with healthcare providers and physicians and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Formulary Coverage, Pricing, and Reimbursement policies could limit our ability to sell bempedoic acid or the bempedoic acid / ezetimibe combination tablet.
  • Recent federal legislation may increase pressure to reduce prices of certain pharmaceutical products paid for by Medicare, which could materially adversely affect our revenue and our results of operations.
The other 55 risks
  • If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions and fines, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
  • Data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
  • Our future success depends on our ability to retain members of our executive management team, and to attract, retain and motivate qualified personnel.
  • Risks Related to Sales, Marketing, and Competition
  • Our market is subject to intense competition. If we are unable to compete effectively, our opportunity to generate revenue from the sale of bempedoic acid or the bempedoic acid / ezetimibe combination tablet in the U.S., in Europe and in other territories will be materially adversely affected.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.
  • Even though we have received marketing approval for bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the U.S. and Europe and several Asian territories, we may never receive regulatory approval to market bempedoic acid or the bempedoic acid / ezetimibe combination tablet in other territories or markets around the world.
  • Even though we have received marketing approval for bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the U.S. and Europe and several Asian territories, they may not achieve broad market acceptance, which would limit the revenue that we generate from their sales.
  • Even though we have obtained marketing approval for bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the U.S. and Europe and several Asian territories, physicians and patients using other LDL-C or CV risk lowering therapies may choose not to switch to our products.
  • Risks Related to Impact of Uncertain Capital Markets
  • Volatility in capital markets and lower market prices for our securities may affect our ability to access new capital through sales of shares of our common stock or issuance of indebtedness, which may materially harm our liquidity, limit our ability to grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.
  • Adverse developments affecting the financial services industry could have an adverse effect on our operations and financial results.
  • Risks Related to Our Business
  • Our internal computer and information technology systems and infrastructure, or those of our third-party clinical research organizations or other contractors or consultants, may fail or suffer security compromises, cybersecurity incidents or breaches, which could result in a material disruption of our bempedoic acid or the bempedoic acid / ezetimibe combination tablet commercialization and development programs.
  • Our employees may engage in misconduct or other improper activities, including violating applicable regulatory standards and requirements or engaging in insider trading, which could significantly harm our business.
  • The increasing use of social media platforms presents new risks and challenges.
  • Changes in tax law could adversely affect our business and financial condition.
  • Our ability to use our net operating loss carryforwards may be subject to limitation.
  • We or the third parties upon whom we depend may be adversely affected by natural disasters, geopolitical developments or global health crises and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Risks Related to Corstasis Acquisition
  • We may fail to complete the acquisition of Corstasis or realize the anticipated benefits of the acquisition, or those benefits may take longer to realize than expected.
  • We may have difficulty integrating the operations of any companies we acquire, which could cause actual results to differ materially and adversely from what we anticipated.
  • Risks Related to Clinical Development, Regulatory Review, and Approval of Our Drugs and Future Drug Candidates
  • Failures or delays in the completion of any of our future clinical trials could result in increased costs to us and could delay, prevent or limit our ability to generate revenue and continue our business.
  • Positive results from completed Phase 1, Phase 2 and Phase 3 clinical studies of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and our CLEAR Outcomes CVOT of bempedoic acid are not necessarily predictive of the results of our future clinical studies, nor do they guarantee approval of bempedoic acid product and the bempedoic acid / ezetimibe combination tablet by the FDA, EMA or any other regulatory agency for additional indications, or approval for any future product candidates.
  • We may fail to obtain orphan drug status for our planned or future product candidates.
  • We may fail to obtain Fast Track designation from the FDA for our current or future product candidates. Even if granted for any of our planned or future product candidates, such expedited programs may not lead to a faster development, regulatory review or approval process, and such designations do not increase the likelihood that any of our product candidates will receive marketing approval in the U.S.
  • We may develop certain of our product candidates as combination therapies. Developing combination treatments increases complexity and risk, including risks of drug-drug interactions, unforeseen side effects or failures in our clinical trials that could delay or prevent their regulatory approval or limit the commercial profile of an approved label.
  • Changes in regulatory requirements, FDA or EMA guidance or unanticipated events may occur, which may result in changes to clinical study protocols or additional clinical study requirements, which could result in increased costs to us and could delay our development timeline.
  • Our future product development programs for candidates other than bempedoic acid or the bempedoic acid / ezetimibe combination tablet may require substantial financial resources and may ultimately be unsuccessful.
  • Inadequate funding for the FDA, the SEC and other U.S. government agencies, including from government shutdowns, or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Risks Related to Litigation
  • We face potential product liability exposure, and, if claims are brought against us, we may incur substantial liability.
  • We may be at an increased risk of securities class action litigation.
  • We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing bempedoic acid and the bempedoic acid / ezetimibe combination tablet.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • Risks Related to Our Financial Position, Capital Needs and Ownership of Our Stock
  • Risks Related to Our Financial Position
  • We have incurred significant operating losses since our inception, and anticipate that we will incur continued losses for the immediate future.
  • Risks Related to our Capital Needs
  • We may need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.
  • If we do not establish successful collaborations, we may have to alter our development and commercialization plans for bempedoic acid and the bempedoic acid / ezetimibe combination tablet.
  • Our payment obligations under the Credit Agreement with the lenders thereto may adversely affect our financial position or results of operations and our ability to raise additional capital which in turn may increase our vulnerability to adverse regulatory developments or economic or business downturns.
  • Risks Related to our Convertible Notes
  • Servicing our debt may require a significant amount of cash. We may not have sufficient cash flow from our business to pay our indebtedness.
  • We may not have the ability to raise the funds necessary for cash settlement upon conversion of the Notes or to repurchase the Notes for cash upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion of the Notes or to repurchase the Notes.
  • The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and results of operations.
  • Transactions relating to our Notes may affect the value of our common stock.
  • Risks Related to Ownership of Our Common Stock
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights.
  • Our executive officers, directors, and principal stockholders, if they choose to act together, will continue to have the ability to exert significant influence over matters subject to stockholder approval.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, even one that may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • We do not intend to pay dividends on our common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • Our stock price may be volatile and an investment in our stock may decline. If we fail to comply with the continuing listing standards of Nasdaq, our securities could be delisted.
  • Risks Related to our Intellectual Property
  • If we are unable to adequately protect our proprietary technology or maintain issued patents which are sufficient to protect bempedoic acid and the bempedoic acid / ezetimibe combination tablet, others could compete against us more directly, which would have a material adverse impact on our business, results of operations, financial condition and prospects.
  • If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and products could be significantly diminished.
  • Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We could become dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing bempedoic acid or the bempedoic acid / ezetimibe combination tablet or other product candidates, if approved.
  • We do not seek to protect our intellectual property rights in all jurisdictions throughout the world and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • Risks Related to our Dependence on Third Parties
  • If a collaborative partner terminates or fails to perform its obligations under an agreement with us, the commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet could be delayed or terminated.
  • We will be unable to directly control all aspects of our clinical studies due to our reliance on CROs and other third parties that assist us in conducting clinical studies.
  • We rely completely on third-party suppliers to manufacture our clinical drug supplies for bempedoic acid and the bempedoic acid / ezetimibe combination tablet and expect to continue to rely on third parties to produce commercial supplies of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and preclinical, clinical and commercial supplies of any future product candidate.
  • General Risk Factors
  • The trading price of our common stock is likely to be volatile, which could result in substantial losses for purchasers of our common stock.

Legal proceedings

On March 27, 2023, we filed a complaint in the United States District Court for the Southern District of New York seeking declaratory judgment against DSE regarding the Company’s right to receive a $300.0 million milestone payment upon inclusion of cardiovascular risk reduction in the EU label that correlates with a relative risk reduction rate of at least 20%, based on the results of the CLEAR Outcomes CVOT. On May 4, 2023, we filed an amended complaint against DSE in the Southern District of New York which seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300.0 million milestone payment to us upon applicable regulatory approval. On June 20, 2023, DSE filed a response to our amended complaint.

On January 2, 2024, we entered into a settlement agreement with DSE to amicably resolve and dismiss the commercial dispute that was pending in the Southern District of New York, or the Settlement Agreement. Under the Settlement Agreement, DSE agreed to pay us an aggregate of $125.0 million, including (1) a $100.0 million payment within 15 business days of the effective date of the Settlement Agreement and (2) a $25.0 million payment in the calendar quarter immediately following the calendar quarter in which the EMA renders a decision on the application that was filed with the EMA for a Type II(a) variation for our oral non-statin products marketed as NILEMDO® (bempedoic acid) tablets and NUSTENDI® (bempedoic acid and ezetimibe) tablets in Europe. The application asks the EMA to approve both NILEMDO and NUSTENDI to reduce cardiovascular risk in patients with or at high risk for ASCVD. The legal action pending in the United States District Court for the Southern District of New York was subsequently dismissed.

The opening of Item 3, Legal Proceedings.17

Sources

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