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What changed in Esperion Therapeutics, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of Esperion Therapeutics, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+659 added−523 removedSource: 10-K (2026-03-10) vs 10-K (2025-03-07)

Top changes in Esperion Therapeutics, Inc.'s 2025 10-K

659 paragraphs added · 523 removed · 421 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

144 edited+67 added−52 removed286 unchanged
Biggest changeThese results were seen in a broad population of primary and 8 Table of Contents secondary prevention patients who are unable to take recommended statin therapy. Furthermore, in several key prespecified subgroups, including females, persons of Hispanic ethnicity, and those with obesity, the beneficial effects observed with bempedoic acid are consistent.
Biggest changeFurthermore, in several key prespecified subgroups, including females, persons of Hispanic ethnicity, those with diabetes, and those with obesity, the beneficial effects observed with bempedoic acid are consistent. The proportions of patients experiencing adverse events and 7 Table of Contents serious adverse events were similar between the active bempedoic acid and placebo treatment groups.
We are engaging in business development activities to potentially leverage our existing commercial organization to help commercialize additional products in the United States. Product Overview NEXLETOL is a first-in-class ACLY inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating the LDL receptors.
We are engaging in business development activities to potentially leverage our existing commercial organization to help commercialize additional products in the United States. Product Overview NEXLETOL is a first-in-class ACLY inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating LDL receptors.
NILEMDO was approved by the EC, in March 2020 for use in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in adult patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies as an adjunct to diet in adult patients who are statin-intolerant, or for whom a statin is contraindicated.
NILEMDO was approved by the EC, in March 2020 for use in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies as an adjunct to diet in adult patients who are statin-intolerant, or for whom a statin is contraindicated.
In May 2024, the EC approved an expanded indication for NILEMDO to reduce cardiovascular risk in patients with or at high risk for ASCVD. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
In May 2024, the EC approved an expanded indication for NILEMDO to reduce cardiovascular risk in patients with or at high risk for ASCVD. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and cholesterol absorption in the intestine.
In addition, under the Pediatric Research Equity Act of 2003, or PREA, as amended made into permanent law pursuant to Food and Drug Administration Safety and Innovation Act (FDASIA), an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
In addition, under the Pediatric Research Equity Act of 2003, or PREA, as amended, made into permanent law pursuant to the Food and Drug Administration Safety and Innovation Act (FDASIA), an NDA or supplement to an NDA must contain data to assess the safety and effectiveness of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damage or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions. • The federal false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services. 28 Table of Contents • Federal price reporting laws require drug manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved products. • Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. • The federal Physician Payments Sunshine Act, or Sunshine Act, enacted as part of the ACA, and its implementing regulations, require certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children's Health Insurance Program (with certain exceptions) to report annually to the HHS under the Open Payments Program, information related to payments and other "transfers of value" provided to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain other licensed health care practitioners and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members. • Analogous state and foreign laws and regulations, such as state anti-kickback, false claims laws, consumer protection, and unfair competition laws, which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales, and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers.
HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damage or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys' fees and costs associated with pursuing federal civil actions. • The federal false statements statute prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services. • Federal price reporting laws require drug manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved products. • Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers. • The federal Physician Payments Sunshine Act, or Sunshine Act, enacted as part of the ACA, and its implementing regulations, require certain manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid, or the Children's Health Insurance Program (with certain exceptions) to report annually to the HHS under the Open Payments Program, information related to payments and other "transfers of value" provided to physicians (defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), certain 28 Table of Contents other licensed health care practitioners and teaching hospitals, and ownership and investment interests held by physicians and their immediate family members. • Analogous state and foreign laws and regulations, such as state anti-kickback, false claims laws, consumer protection, and unfair competition laws, which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales, and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payor, including commercial insurers.
Our lead products NEXLETOL® (bempedoic acid) tablets and NEXLIZET® (bempedoic acid and ezetimibe) tablets are oral, once-daily, non-statin medicines indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established CVD, or at high risk for a CVD event but without established CVD, and to reduce LDL-C in adults with primary hyperlipidemia.
Our lead products NEXLETOL® (bempedoic acid) tablets and NEXLIZET® (bempedoic acid and ezetimibe) tablets are oral, once-daily, non-statin medicines indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable or unwilling to take recommended statin therapy (including those not taking a statin) with established CVD, or at high risk for a CVD event but without established CVD, and to reduce LDL-C in adults with primary hyperlipidemia.
All new marketing authorization applications, or MAAs, must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization.
All new marketing authorization applications, must include a risk management plan, or RMP, describing the risk management system that the company will put in place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also impose specific obligations as a condition of the marketing authorization.
We believe that this patent could be the subject of an additional six month pediatric exclusivity period. We have one granted European patent that has been validated in numerous European countries including France, Germany, Great Britain, Ireland, Italy, the Netherlands, Spain, Sweden and Switzerland.
We believe that this patent could also be the subject of an additional six month pediatric exclusivity period. We have one granted European patent that has been validated in numerous European countries including France, Germany, Great Britain, Ireland, Italy, the Netherlands, Spain, Sweden and Switzerland.
On March 4, 2023, we announced the full results from the CLEAR Outcomes trial at the Scientific Sessions of the American College of Cardiology with a simultaneous publication in the New England Journal of Medicine .
On March 4, 2023, we announced the full results from the CLEAR Outcomes trial at the Scientific Sessions of the American College of Cardiology with a simultaneous publication in the New England Journal of Medicine (NEJM) .
The main characteristics of the Regulation include: a streamlined application procedure via a single-entry point through the Clinical Trials Information System, or CTIS; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided in two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation).
The main characteristics of the Regulation include: a streamlined application procedure via a single-entry point through the Clinical Trials Information System, or CTIS; a single set of documents to be prepared and submitted for the application as well as simplified reporting procedures for clinical trial sponsors; and a harmonized procedure for the assessment of applications for clinical trials, which is divided into two parts (Part I contains scientific and medicinal product documentation and Part II contains the national and patient-level documentation).
The IRA includes several provisions that will impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay until January 1, 2032 the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries.
The IRA includes several provisions that will impact our business to varying degrees, including provisions that create a $2,000 out-of-pocket cap 24 Table of Contents for Medicare Part D beneficiaries, impose new manufacturer financial liability on all drugs in Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D pricing for certain high-cost drugs and biologics without generic or biosimilar competition, require companies to pay rebates to Medicare for drug prices that increase faster than inflation, and delay until January 1, 2032 the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries.
Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. • The federal civil and criminal false claims laws, including the federal False Claims Act, impose criminal and civil penalties, and authorizes civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment by a federal healthcare program; making, using, or causing to be made or used, a false statement or record material to payment of a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.
Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. 27 Table of Contents • The federal civil and criminal false claims laws, including the federal False Claims Act, impose criminal and civil penalties, and authorizes civil whistleblower or qui tam actions, against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment by a federal healthcare program; making, using, or causing to be made or used, a false statement or record material to payment of a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal government.
In recent years, additional laws have resulted in direct or indirect reimbursement reductions for certain Medicare providers, including: • The Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year and, due to subsequent legislative amendments to the statute, will remain in effect through 2031. • The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. • On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law.
In recent years, additional laws have resulted in direct or indirect reimbursement reductions for certain Medicare providers, including: • The Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers of 2% per fiscal year and, due to subsequent legislative amendments to the statute, will remain in effect through 2031. 25 Table of Contents • The American Taxpayer Relief Act of 2012, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. • On March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law.
We will continue to spend on the promotional activities, marketing, and field force related to the continued launch of our expanded label in 2025. Manufacturing and Supply Bempedoic acid and the bempedoic acid / ezetimibe combination tablet are small molecule drugs that are synthesized from readily available raw materials using conventional chemical processes. We currently have no manufacturing facilities.
We will continue to spend on the promotional activities, marketing, and field force related to the continued launch of our expanded label in 2026. Manufacturing and Supply Bempedoic acid and the bempedoic acid / ezetimibe combination tablet are small molecule drugs that are synthesized from readily available raw materials using conventional chemical processes. We currently have no manufacturing facilities.
The DSE Amendment and the DS Amendment grant each of DSE and DS exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in their existing respective territories of the EEA, UK, Switzerland and Turkey, or the DSE Territory, and South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, Macao, Cambodia and Myanmar, or the DS Territory.
The DSE Amendment and the DS Amendment grant each of DSE and DS exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in their existing respective territories of the EEA, UK, Switzerland and Turkey, or the DSE Territory, and South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, and Macao, or the DS Territory.
If we fail to complete the development of bempedoic acid or the bempedoic acid / ezetimibe combination tablet in other territories outside the U.S. and Europe (including obtaining additional potential indications), or any other product candidates we may develop, our ability to generate future revenue and our results of operations and financial position may be adversely affected.
If we fail to complete the development of bempedoic acid or the bempedoic acid / ezetimibe combination tablet in other territories outside the U.S. and Europe (including obtaining additional potential indications) and the other approved countries, or any other product candidates we may develop, our ability to generate future revenue and our results of operations and financial position may be adversely affected.
On August 26, 2023, a prespecified analysis of the total number of cardiovascular events in the CLEAR Outcomes trial population was presented at the European Society of Cardiology and subsequently published in JAMA Cardiology . The results reflect the impact of bempedoic acid on the total incidence of MACE, not just the first event.
On August 26, 2023, a prespecified analysis of the total number of cardiovascular events in the CLEAR Outcomes trial population was presented at the European Society of Cardiology, or ESC, and subsequently published in JAMA Cardiology . The results reflect the impact of bempedoic acid on the total incidence of MACE, not just the first event.
Pursuant to Regulation (EC) No. 726/2004, the CP is mandatory for specific products, including for medicinal products produced by certain biotechnological processes, advanced-therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines), products designated as orphan medicinal drugs, 30 Table of Contents and medicinal drugs containing a new active substance indicated for the treatment of HIV or AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions, and viral diseases.
Pursuant to Regulation (EC) No. 726/2004, the CP is mandatory for specific products, including for medicinal products produced by certain biotechnological processes, advanced-therapy medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines), products designated as orphan medicinal drugs, and medicinal drugs containing a new active substance indicated for the treatment of HIV or AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions, and viral diseases.
Part I is assessed by a coordinated review by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned) of a draft report prepared by a Reference Member State. Part II is assessed separately by each Member State concerned.
Part I is assessed by a coordinated review by the competent authorities of all EU Member States in which an application for authorization of a clinical trial has been submitted (Member States concerned) of a draft report prepared by a Reporting Member State. Part II is assessed separately by each Member State concerned.
The manufacturer or importer must have a qualified person who is responsible for certifying that each batch of product has been manufactured in accordance with EU standards of cGMP before releasing the product for commercial distribution in the EU or for use in a clinical trial.
The manufacturer or importer must have a qualified person who is responsible for certifying that each batch of product has been manufactured in accordance with EU GMP standards before releasing the product for commercial distribution in the EU or for use in a clinical trial.
The duration of foreign patents varies in 16 Table of Contents accordance with provisions of applicable local law, but typically is also twenty years from the earliest effective filing date. Our issued U.S. patents relating to bempedoic acid, including patent term extensions we obtained, will expire on dates ranging from late-2030 to mid-2040.
The duration of foreign patents varies in accordance with provisions of applicable local law, but typically is also twenty years from the earliest effective filing date. Our issued U.S. patents relating to bempedoic acid, including patent term extensions we obtained, will expire on dates ranging from late-2030 to mid-2040.
The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, 23 Table of Contents that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug.
The FDCA also provides three years of marketing exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example new indications, dosages or strengths of an existing drug.
Net prices for NEXLETOL and NEXLIZET or any future approved drugs may also be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.
Net prices for NEXLETOL and NEXLIZET or any future approved drugs may also be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower 23 Table of Contents prices than in the United States.
However, the use of ezetimibe is markedly low in the US; in the GOULD registry (Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management; 2016-2018) of adults with ASCVD, only 6.8% of patients with LDL-C ≥100 mg/dL had ezetimibe added for LLT intensification.
However, the use of ezetimibe is markedly low in the US; in the GOULD registry (Getting to an Improved Understanding of 11 Table of Contents Low-Density Lipoprotein Cholesterol and Dyslipidemia Management; 2016-2018) of adults with ASCVD, only 6.8% of patients with LDL-C ≥100 mg/dL had ezetimibe added for LLT intensification.
Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with cGMP. Pricing and Reimbursement Governments influence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.
Manufacturing facilities are subject to periodic inspections by the competent authorities for compliance with cGMP. 32 Table of Contents Pricing and Reimbursement Governments influence the price of medicinal products in the EU through their pricing and reimbursement rules and control of national healthcare systems that fund a large part of the cost of those products to consumers.
Statins are selective, competitive inhibitors of HMG-CoA reductase, a rate-limiting enzyme in the cholesterol biosynthesis pathway in liver cells. Statin inhibition of cholesterol synthesis increases the number of LDL receptors on the surface of liver 11 Table of Contents cells. This increase in LDL receptors increases uptake of LDL particles into liver cells from the blood, thus lowering LDL-C levels.
Statins are selective, competitive inhibitors of HMG-CoA reductase, a rate-limiting enzyme in the cholesterol biosynthesis pathway in liver cells. Statin inhibition of cholesterol synthesis increases the number of LDL receptors on the surface of liver cells. This increase in LDL receptors increases uptake of LDL particles into liver cells from the blood, thus lowering LDL-C levels.
These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, voluntary product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement 18 Table of Contents or civil or criminal penalties.
These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, voluntary product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.
Any marketing authorization which is not followed by the actual placing of the medicinal product on the EU market (in the case of the CP) or on the market of the authorizing EU Member State (for a nationally authorized product) within three years after authorization, ceases to be valid (the so-called sunset clause).
Any marketing authorization which is not 31 Table of Contents followed by the actual placing of the medicinal product on the EU market (in the case of the CP) or on the market of the authorizing EU Member State (for a nationally authorized product) within three years after authorization, ceases to be valid (the so-called sunset clause).
During the year ended December 31, 2024, we recognized $115.7 million in net product sales of NEXLETOL and NEXLIZET and $216.6 million in collaboration revenue, primarily related to the settlement with DSE, or the DSE Settlement, a milestone from Otsuka upon first Japanese New Drug Application, or JNDA, submission in the Otsuka Territory, sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
During the year ended December 31, 2024, we recognized $115.7 million in net product sales of NEXLETOL and NEXLIZET and $216.6 million in collaboration revenue, primarily related to the settlement with Daiichi Sankyo Europe GmbH, or DSE, or the DSE Settlement, a milestone from Otsuka upon first Japanese New Drug Application, or JNDA, submission in the Otsuka Territory, sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
These laws and regulations may result in additional reductions in Medicare and 26 Table of Contents other healthcare funding available for healthcare providers and may otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
These laws and regulations may result in additional reductions in Medicare and other healthcare funding available for healthcare providers and may otherwise affect the prices we may obtain for any of our product candidates for which we may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.
Congress and the Trump administration have indicated that they will continue to seek new legislative measures to control drug costs. We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S.
Congress and the Trump administration have indicated that they will continue to seek new legislative measures to control drug costs. 26 Table of Contents We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S.
We plan to continue to rely upon contract manufacturers and, potentially, in connection with the transfer of certain manufacturing responsibilities to DSE, collaboration partners to manufacture commercial 14 Table of Contents quantities of the bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the United States and in Europe and in territories outside of the United States and Europe.
We plan to continue to rely upon contract manufacturers and, potentially, in connection with the transfer of certain manufacturing responsibilities to DSE, collaboration partners to manufacture commercial quantities of the bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the United States and in Europe and in territories outside of the United States and Europe.
The law's requirements include the quarantine and prompt investigation of a suspect product to determine if it is illegitimate and notifying trading partners and the FDA of any illegitimate product. Drug manufacturers and their collaborators are also required to place a unique product identifier on prescription drug packages.
Additionally, the requirements of the DSCSA include the quarantine and prompt investigation of a suspect product to determine if it is illegitimate and notifying trading partners and the FDA of any illegitimate product. Drug manufacturers and their collaborators are also required to place a unique product identifier on prescription drug packages.
In addition, the new arrangements require all medicines placed on the UK market to be labelled “UK only”, indicating they are not for sale in the EU.
In addition, the new arrangements require all medicines placed on the UK market to be labelled “UK Only", indicating they are not for sale in the EU.
Parties conducting certain clinical trials must, as in the United States, post clinical trial information in the EU through the CTIS. Marketing Authorization In the EU, medicinal products can only be commercialized after obtaining an EU marketing authorization. There are two types of marketing authorizations.
Parties conducting certain clinical trials must, as in the United States, post clinical trial information in the EU through the CTIS. 30 Table of Contents Marketing Authorization In the EU, medicinal products can only be commercialized after obtaining an EU marketing authorization. There are two types of marketing authorizations.
ANDA Litigation Starting in March 2024, the Company received notices from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL and four of which filed with respect to NEXLETOL and NEXLIZET (each, an “ANDA Filer”), notifying the Company that each company had filed an ANDA with the FDA seeking approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
ANDA Litigation Starting in March 2024, the Company received notices from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL and four of which filed with respect to NEXLETOL and NEXLIZET (each, an “ANDA Filer”), notifying the Company that each company had filed an Abbreviated New Drug Application ("ANDA") with the FDA seeking approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
While preclinical studies and Mendelian randomized trials support a causal role for ACLY in dyslipidemia and ASCVD, they also 9 Table of Contents suggest potential additional effects on metabolism that may benefit other disease states such as type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic associated steatohepatitis (MASH).
While preclinical studies and Mendelian randomized trials support a causal role for ACLY in dyslipidemia and ASCVD, they also suggest potential additional effects on metabolism that may benefit other disease states such as type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic associated steatohepatitis (MASH).
To facilitate talent attraction and retention, we strive to make Esperion a safe and rewarding workplace, with opportunities for our employees to grow and develop in their careers, supported by strong compensation, benefits and health and wellness programs, and by programs that build connections between our employees. As of December 31, 2024, we had 304 full-time employees.
To facilitate talent attraction and retention, we strive to make Esperion a safe and rewarding workplace, with opportunities for our employees to grow and develop in their careers, supported by strong compensation, benefits and health and wellness programs, and by programs that build connections between our employees. As of December 31, 2025, we had 294 full-time employees.
Under the Hatch-Waxman Act to the FDCA, the Company had 45 days from receipt of the notice letters to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court to trigger a stay precluding the FDA’s approval of any ANDA from being effective any earlier than 7.5 years from the date of approval of the NEXLETOL or NEXLIZET, as applicable, NDA or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.
Under the Hatch-Waxman Act to the Federal Food, Drug, and Cosmetic Act ("FDCA"), the Company had 45 days from receipt of the notice letters to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court to trigger a stay precluding the FDA’s approval of any ANDA from being effective any earlier than 7.5 years from the date of approval of the NEXLETOL or NEXLIZET, as applicable, new drug application or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.
The completed Phase 3 Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial in patients unwilling or 7 Table of Contents unable to take statins and who had, or were at high risk for, CVD demonstrated on average a 20.0% placebo corrected LDL-C lowering, and a resulting 13% lower risk of major cardiovascular events versus placebo.
The completed Phase 3 Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial in patients unwilling or unable to take statins and who had, or were at high risk for, CVD demonstrated on average a 20% placebo-corrected LDL-C reduction, and a resulting 13% lower risk of major cardiovascular events versus placebo.
In addition, we regularly use our website to post information regarding our business, product development programs and 34 Table of Contents governance, and we encourage investors to use our website, particularly the investor relations page, as a source of information about us.
In addition, we regularly use our website to post information regarding our business, product development programs and governance, and we encourage investors to use our website, particularly the investor relations page, as a source of information about us.
However, any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request.
However, any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant shorter extensions than we request.
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a 29 Table of Contents number of investigations, prosecutions, convictions, and settlements in the healthcare industry.
Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions, and settlements in the healthcare industry.
Therefore, patent applications relating to drugs similar to bempedoic acid and any future drugs, discoveries or technologies we might develop may have already been filed by others without our knowledge. 17 Table of Contents Competition Our industry is highly competitive and subject to rapid and significant technological change.
Therefore, patent applications relating to drugs similar to bempedoic acid and any future drugs, discoveries or technologies we might develop may have already been filed by others without our knowledge. Competition Our industry is highly competitive and subject to rapid and significant technological change.
Further, an institutional review board, or IRB, must review and approve the plan for any clinical study before it commences at any institution. An IRB considers, among other things, whether the risks to individuals participating in the clinical study are minimized and are reasonable in relation to anticipated benefits.
Further, an institutional review board, or IRB, must review and approve the plan for any clinical study before it commences at any institution. An IRB considers, among other things, whether the risks to individuals participating in the clinical study are 18 Table of Contents minimized and are reasonable in relation to anticipated benefits.
Any agency or judicial enforcement action could have a material adverse effect on us. United States Drug Review and Approval United States Drug Development Process In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations.
Any agency or judicial enforcement action could have a material adverse effect on us. 17 Table of Contents United States Drug Review and Approval United States Drug Development Process In the United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations.
In certain therapeutic areas, the FDA may grant a conditional approval, or Subpart H, approval if the agreed regulatory path is based on a surrogate endpoint that requires a confirmatory clinical trial to be initiated at the time of Subpart H approval.
In certain therapeutic areas, the FDA may grant an accelerated approval, or Subpart H, approval if the agreed regulatory path is based on a surrogate endpoint that generally requires a confirmatory clinical trial to be initiated at the time of Subpart H approval.
For example, the agency will waive the application fee for the first human drug application that a small business or its affiliate submits for review or for a drug that received orphan drug designation from FDA. The Company obtained a Small Business Waiver from the FDA related to bempedoic acid.
For example, the agency will waive the application fee for the first human drug application that a small business or its affiliate submits for review or for a drug that received orphan drug designation from FDA. The Company obtained a Small Business Waiver from the FDA 19 Table of Contents related to bempedoic acid.
In November 2020, the OIG issued a Fraud Alert highlighting its view that pharmaceutical promotional speaker programs can pose a high risk of fraud and abuse.
In November 2020, the OIG 29 Table of Contents issued a Fraud Alert highlighting its view that pharmaceutical promotional speaker programs can pose a high risk of fraud and abuse.
In the future, we may become party to legal matters and claims arising in the ordinary course of business, the resolution of which we do not anticipate would have a material adverse impact on our financial position, results of operations or cash flows. Available Information Our website address is www.esperion.com.
No trial date has been set. In the future, we may become party to legal matters and claims arising in the ordinary course of business, the resolution of which we do not anticipate would have a material adverse impact on our financial position, results of operations or cash flows. Available Information Our website address is www.esperion.com.
The estimated US prevalence of risk groups based on NHANES is provided below. 10 Table of Contents US Prevalence Estimates by Statin-Eligible Groups Patient Subgroup Estimated Prevalence (in Millions) ASCVD and age ≥21 years 24.6 LDL-C ≥190 mg/dL 2.3 Diabetes mellitus (DM), age 40 – 75 years 15 ASCVD risk ≥20% 9.4 Intermediate ASCVD (≥7.5% to 20 Total 71.3 Patients with HeFH or established ASCVD who require additional lowering of LDL-C We initially developed bempedoic acid and the bempedoic acid /ezetimibe combination tablet as an adjunct to diet and statin therapy for patients with HeFH and/or ASCVD who require additional lowering of LDL-C.
US Prevalence Estimates by Statin-Eligible Groups Patient Subgroup Estimated Prevalence (in Millions) ASCVD and age ≥21 years 24.6 LDL-C ≥190 mg/dL 2.3 Diabetes mellitus (DM), age 40 – 75 years 15 ASCVD risk ≥20% 9.4 Intermediate ASCVD (≥7.5% to 20 Total 71.3 Patients with HeFH or established ASCVD who require additional lowering of LDL-C We initially developed bempedoic acid and the bempedoic acid /ezetimibe combination tablet as an adjunct to diet and statin therapy for patients with HeFH and/or ASCVD who require additional lowering of LDL-C.
In addition to new legislation, FDA regulations, guidance, and policies are often revised or reinterpreted by the agency in ways that may significantly affect the manner in which pharmaceutical products are regulated and marketed.
In addition to 21 Table of Contents new legislation, FDA regulations, guidance, and policies are often revised or reinterpreted by the agency in ways that may significantly affect the manner in which pharmaceutical products are regulated and marketed.
We announced collaboration agreements for the commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet with DSE in 2019, with Otsuka in 2020 and with DS, in 2021. We continue to engage in partnering discussions with potential third-party collaborators.
We announced collaboration agreements for the commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet with DSE in 2019, with Otsuka in 2020, and with Daiichi Sankyo Co. Ltd, or DS, in 2021. We continue to engage in partnering discussions with potential third-party collaborators.
In this event, the NDA must 20 Table of Contents be re-submitted with the additional information. The re-submitted application also is subject to review before the FDA accepts it for filing.
In this event, the NDA must be re-submitted with the additional information. The re-submitted application also is subject to review before the FDA accepts it for filing.
On May 4, 2023, we filed an amended complaint against DSE in the Southern District 33 Table of Contents of New York which seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to us upon applicable regulatory approval.
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 million milestone payment to us upon applicable regulatory approval. On June 20, 2023, DSE filed a response to our amended complaint.
Five of our employees have Ph.D. degrees, two have M.D. degrees and twenty have PharmD degrees. 38 of our employees are engaged in research and development activities. None of our employees are represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.
Four of our employees have Ph.D. degrees, two have M.D. degrees and seventeen have PharmD degrees. 40 of our employees are engaged in research and development activities. None of our employees are represented by labor unions or covered by collective bargaining agreements. We consider our relationship with our employees to be good.
A centralized marketing authorization is valid throughout the entire territory of the EU, and in the additional countries of the EEA (i.e., Iceland, Liechtenstein and Norway).
A centralized marketing authorization is valid throughout the entire territory of the EU, and in the additional countries of the European Economic Area, or EEA (i.e., Iceland, Liechtenstein and Norway).
Beginning in May 2024, the Company filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against each ANDA Filer: Accord Healthcare Inc.; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy’s Laboratories Inc. (along with an affiliate); Hetero USA Inc. (along with affiliates); Micro Labs USA Inc.
Beginning in May 2024, the Company filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against each ANDA Filer: Accord Healthcare Inc.; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with its affiliate); Dr. Reddy’s Laboratories Inc. (along with its affiliate, collectively, “Dr. Reddy’s Laboratories”); Hetero USA Inc.
Legal Proceedings DSE Litigation 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 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.
We believe that our existing facilities are adequate for our current needs. 33 Table of Contents Legal Proceedings DSE Litigation 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 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.
Patent No. 11,116,739, one pending U.S. patent application, and 12 granted patents and 11 pending applications outside the U.S., with claims directed to fixed dose combinations of bempedoic acid and one or more statins and/or methods of using said fixed dose combinations. U.S. Patent No. 11,116,739 is scheduled to expire in March 2036.
Patent No. 11,116,739, one pending U.S. patent application, and 13 granted patents and 9 pending applications outside the U.S., directed to fixed dose combinations of bempedoic acid and one or more statins and/or methods of using such fixed dose combinations. U.S. Patent No. 11,116,739 is scheduled to expire in March 2036.
Our selling, general, and administrative expense will remain consistent in 2025. As noted above, we increased our commercial organization and sales force in 2024 in anticipation of the new expanded cardiovascular outcomes label for NEXLETOL and NEXLIZET and expect our spend to stay consistent year over year.
Our selling, general, and administrative expense in 2026 is expected to remain consistent with 2025. As noted above, we increased our commercial organization and sales force in 2024 in anticipation of the new expanded cardiovascular outcomes 13 Table of Contents label for NEXLETOL and NEXLIZET and expect our spend to stay consistent year over year.
Other Member States allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on 32 Table of Contents healthcare costs in general, particularly prescription medicines, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.
Other Member States allow companies to fix their own prices for medicines, but monitor and control company profits. The downward pressure on healthcare costs in general, particularly prescription medicines, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products. All of the aforementioned EU rules are generally applicable in the EEA.
Research and Development Expenses Research and development expenses for the year ended December 31, 2024, were $46.2 million, which was primarily related to clinical development costs relating to ongoing clinical studies and compensation related costs, including stock-based compensation.
Research and Development Expenses Research and development expenses for the year ended December 31, 2025, were $47.9 million, which was primarily related to clinical development costs relating to ongoing clinical studies and compensation related costs, including stock-based compensation.
We expect research and development expenses to increase slightly in 2025 due to the start of our phase III pediatric trial and the continuing advancement of our preclinical pipeline. Selling, General and Administrative We established our commercialization and distribution capabilities with the commercial launch of NEXLETOL and NEXLIZET in the U.S.
We expect research and development expenses to remain consistent in 2026 due to the continuation of our phase III pediatric trial and the continuing advancement of our preclinical pipeline. Selling, General and Administrative We established our commercialization and distribution capabilities with the commercial launch of NEXLETOL and NEXLIZET in the U.S.
State and foreign laws also govern the privacy and security of health information in certain circumstances. Such data privacy and security laws may differ from one another in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. In the United States, there is a growing body of stringent privacy and data security legislation.
State and foreign laws also govern the privacy and security of health information in certain circumstances. Such data privacy and security laws may differ from one another in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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.
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.
Bempedoic acid demonstrated a benefit in patients with diabetes at baseline, showing a 17% reduction in cardiovascular risk. For patients without diabetes at enrollment, bempedoic acid use was not associated with an increased risk of new onset diabetes compared with placebo, which is a key differentiating feature compared to statins.
For patients without diabetes at enrollment, bempedoic acid use was not associated with an increased risk of new onset diabetes compared with placebo, which is a key differentiating feature compared to statins.
Reform of the Regulatory Framework in the EU The European Commission adopted legislative proposals in April 2023 that replaced the current regulatory framework in the EU for all medicines (including those for rare diseases and for children).
Reform of the Regulatory Framework in the EU The European Commission introduced legislative proposals in April 2023 that, if implemented, will replace the current regulatory framework in the EU for all medicines (including those for rare diseases and for children).
Marketing Opportunity for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet Overall, 71 million adults in the US are at high risk of CVD and eligible for statin therapy according to the AHA/ACC guidelines.
Marketing Opportunity for Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet Overall, 71 million adults in the US are at high risk of CVD and eligible for statin therapy according to the AHA/ACC guidelines. The estimated US prevalence of risk groups based on NHANES is provided below.
During the year ended December 31, 2022, we recognized $55.9 million in net product sales of NEXLETOL and NEXLIZET and $19.6 million in collaboration revenue, primarily related to sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
During the year ended December 31, 2025, we recognized $159.6 million in net product sales of NEXLETOL and NEXLIZET and $243.6 million in collaboration revenue, primarily related to milestone payments from Ostuka, sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
While there is an exception for protected health information that is subject to HIPAA and clinical trial regulations, the CCPA may impact our business activities if we become a "business" regulated by the scope of the CCPA or a service provider to a regulated business.
While there is an exception for protected health information that is subject to HIPAA and clinical trial regulations, the CCPA may impact our business activities if we become a "business" regulated by the scope of the CCPA or a service provider to a regulated business. In addition to the CCPA, numerous other states have enacted similarly comprehensive privacy legislation.
We also have one pending U.S. patent application, and 10 granted patents and 10 pending applications outside the U.S. with claims directed to methods of treatment using the bempedoic acid / ezetimibe combination tablet.
This family also includes one pending U.S. patent application, and 10 granted patents and 9 pending applications outside the U.S., directed to methods of treatment using the bempedoic acid / ezetimibe combination tablet.
As of December 31, 2024, our patent estate, including patents we own, on a worldwide basis, included approximately 11 issued United States patents and 10 pending United States patent applications and over 30 issued patents and over 90 pending patent applications in other foreign jurisdictions.
As of December 31, 2025, our patent estate, including patents we own, on a worldwide basis, included approximately 12 issued United States patents and 12 pending United States patent applications and over 40 issued patents and over 80 pending patent applications in other foreign jurisdictions.
Market exclusivity provisions under the FDCA can also delay the submission or the approval of certain applications. The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity, or NCE.
The FDCA provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an NDA for a new chemical entity, or NCE.
In the U.S., the FDA regulates prescription drug promotion, including direct-to-consumer advertising. Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use. Any distribution of prescription drugs and pharmaceutical samples must comply with the U.S. Prescription Drug Marketing Act, or the PDMA, a part of the FDCA.
The FDA has recently increased its surveillance and enforcement activity for direct-to-consumer advertising of prescription drug products. Prescription drug promotional materials must be submitted to the FDA in conjunction with their first use. Any distribution of prescription drugs and pharmaceutical samples must comply with the U.S. Prescription Drug Marketing Act, or the PDMA, a part of the FDCA.
The Company’s complaints allege that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL’s and/or NEXLIZET’s Orange Book patents, as applicable, included in its Paragraph IV certifications, and seek an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL and/or NEXLIZET, as applicable, until the expiration of the asserted patents.
The Company’s complaints allege that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL’s and/or NEXLIZET’s Orange Book patents, as applicable, included in its Paragraph IV certifications, and seek an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL and/or NEXLIZET, as applicable, until the expiration of the asserted patents. 34 Table of Contents The Company subsequently reached settlement agreements with Micro Labs, Hetero USA, Accord Healthcare Inc., Dr.
NDA holders can apply for restorations of patent term to add patent life beyond current expiration dates, depending on the expected length of the clinical studies and other factors involved in the filing of the relevant NDA; however, there can be no assurance that any such extension will be granted to us.
NDA holders can apply for restorations of patent term to add patent life beyond current expiration dates, depending on the expected length of the clinical studies and other factors involved in the filing of the relevant NDA; however, there can be no assurance that any such extension will be granted to us. 22 Table of Contents Market exclusivity provisions under the FDCA can also delay the submission or the approval of certain applications.
Untreated Patients Due to a myriad of reasons, as many as 40 million adults in the US with ASCVD or at high-risk for ASCVD remain untreated with statins. This gap in care represents an important public health opportunity.
Untreated Patients Due to a myriad of reasons, as many as 40 million adults in the US with ASCVD or at high-risk for ASCVD remain untreated with statins.
The CCPA broadly defines personal information, gives California residents expanded privacy rights and protections, and places stringent privacy and security obligations on business covered by the law. Further, the California Privacy Rights Act, or CPRA, amended the CCPA and as of January 1, 2023, created additional obligations with respect to processing and safeguarding personal information.
In California, for example, the California Consumer Privacy Act, or CCPA, broadly defines personal information, gives California residents individual privacy rights and protections, and places stringent privacy and security obligations on business covered by the law. The California Privacy Rights Act, or CPRA, amended the CCPA and, created additional obligations with respect to processing and safeguarding personal information.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeThe market price for our common stock may be influenced by many factors, including: • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • the timing and results of clinical trials of product candidates, or our competitors’ product candidates; • regulatory actions with respect to our product candidates or our competitors’ products and product candidates; • commencement or termination of collaborations for our development programs; • failure or discontinuation of any of our development programs; • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights; • the recruitment or departure of key personnel; • the level of expenses related to any of our product candidates or clinical development programs; • the results of our efforts to develop additional product candidates; • actual or anticipated changes in estimates as to our commercial performance, financial results or development timelines; • announcement or expectation of additional financing efforts; • sales of our common stock by us, our insiders or other stockholders, including shares issuable upon exercise of outstanding stock options and upon vesting of stock units under our stock incentive plans; • variations in our financial results or results of companies that are perceived to be similar to us; • whether an active trading market for our shares is sustained; • changes in estimates, evaluations or recommendations by securities analysts, that cover our stock or the failure by one or more securities analysts to continue to cover our stock; • changes in the structure of healthcare payment systems; • the societal and economic impact of any future public health epidemics, pandemics or outbreaks of infectious disease and any recession, depression or sustained market event resulting from such public health crises; • market conditions in the pharmaceutical and biotechnology sectors; • general economic, political, industry and market conditions; and • the other factors described in this “Risk Factors” section. 74 Table of Contents We also cannot guarantee that an active trading market for our shares will be sustained.
Biggest changeThe market price for our common stock may be influenced by many factors, including: • announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments; • the timing and results of clinical trials of product candidates, or our competitors’ product candidates; • regulatory actions with respect to our product candidates or our competitors’ products and product candidates; • commencement or termination of collaborations for our development programs; • failure or discontinuation of any of our development programs; • regulatory or legal developments in the United States and other countries; • developments or disputes concerning patent applications, issued patents or other proprietary rights, including challenges to the validity, scope or enforceability of our issued patents, litigation or other proceedings arising from ANDA filings or similar regulatory submissions, and our ability to defend and enforce our intellectual property rights; • the recruitment or departure of key personnel; • the level of expenses related to any of our product candidates or clinical development programs; • the results of our efforts to develop additional product candidates; • our ability to expand and advance our pipeline through business development activities, including collaborations, licensing arrangements or other strategic transactions, and our ability to execute and realize the anticipated and potential benefits of any such transactions we may pursue; • actual or anticipated changes in estimates as to our commercial performance, financial results or development timelines; • announcement or expectation of additional financing efforts; • sales of our common stock by us, our insiders or other stockholders, including shares issuable upon exercise of outstanding stock options and upon vesting of stock units under our stock incentive plans; • variations in our financial results or results of companies that are perceived to be similar to us; • whether an active trading market for our shares is sustained; • changes in estimates, evaluations or recommendations by securities analysts, that cover our stock or the failure by one or more securities analysts to continue to cover our stock; • changes in the structure of healthcare payment systems; • market conditions in the pharmaceutical and biotechnology sectors; 79 Table of Contents • general economic, geopolitical, industry and market conditions; and • the other factors described in this “Risk Factors” section.
Additionally, we cannot be certain that we will be able to obtain approval for either of our candidates for any other indication or approval of any future product candidates.
Additionally, we cannot be certain that we will be able to obtain approval for either of our candidates for any other indication or obtain or approval of any future product candidates.
As of January 1, 2023, the amendments to the CCPA introduced by the CPRA imposed additional obligations on companies covered by the legislation, including by expanding consumers’ rights with respect to certain sensitive personal information. The amendments introduced by the CPRA also created a new state agency that is vested with authority to implement and enforce the CCPA.
As of January 1, 2023, amendments to the CCPA introduced by the CPRA imposed additional obligations on companies covered by the legislation, including by expanding consumers’ rights with respect to certain sensitive personal information. The amendments introduced by the CPRA also created a new state agency that is vested with authority to implement and enforce the CCPA.
In addition, we are required to timely file accurate quarterly and annual reports with the SEC under the Securities Exchange Act of 1934, or the Exchange Act, as amended.
In addition, we are required to timely file accurate quarterly and annual reports with the SEC under the Securities Exchange Act of 1934, as amended, or the Exchange Act.
Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or if the BIOSECURE Act or a similar law were to be enacted.
Our ability or the ability of our collaborators or such other third parties to continue to engage these China-based suppliers or service providers for certain preclinical research programs and clinical development programs could be restricted due to geopolitical developments between the United States and China, including as a result of the escalation of tariffs or other trade restrictions or the enactment of the BIOSECURE Act or if a similar law were to be enacted.
The effects of the CCPA are potentially significant and may require us to modify our data collection or processing practices and policies and to incur substantial costs and expenses in an effort to comply and increase our potential exposure to regulatory enforcement and/or litigation. Following California, numerous other states have enacted or proposed laws similar to the CCPA.
The effects of the CCPA are significant and may require us to modify our data collection or processing practices and policies and to incur substantial costs and expenses in an effort to comply and increase our potential exposure to regulatory enforcement and/or litigation. Following California, numerous other states have enacted or proposed laws similar to the CCPA.
For further details, please see our risk factor entitled “ 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.” The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: • any of our patents, or any of our pending patent applications, if issued, will include claims having a scope and patent term sufficient to protect bempedoic acid or the bempedoic acid / ezetimibe combination tablet; • any of our pending patent applications will result in issued patents; 68 Table of Contents • we will be able to successfully commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet in all of the jurisdictions we intend to pursue before our relevant patents expire; • we were the first to make the inventions covered by each of our patents and pending patent applications; • we were the first to file patent applications for these inventions; • others will not develop similar or alternative technologies that do not infringe our patents; • any of our patents will be valid and enforceable; • any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; • we will develop additional proprietary technologies or product candidates that are separately patentable; or • that our commercial activities or products, or those of our licensors, will not infringe upon the patents of others.
For further details, please see our risk factor entitled “ 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.” The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that: • any of our patents, or any of our pending patent applications, if issued, will include claims having a scope and patent term sufficient to protect bempedoic acid or the bempedoic acid / ezetimibe combination tablet; • any of our pending patent applications will result in issued patents; • we will be able to successfully commercialize bempedoic acid or our bempedoic acid / ezetimibe combination tablet in all of the jurisdictions we intend to pursue before our relevant patents expire; • we were the first to make the inventions covered by each of our patents and pending patent applications; 73 Table of Contents • we were the first to file patent applications for these inventions; • others will not develop similar or alternative technologies that do not infringe our patents; • any of our patents will be held valid and enforceable; • any patents issued to us will provide a basis for an exclusive market for our commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; • we will develop additional proprietary technologies or product candidates that are separately patentable; or • that our commercial activities or products, or those of our licensors, will not infringe upon the patents of others.
Market acceptance of bempedoic acid and the bempedoic acid / ezetimibe combination tablet will depend on a number of factors, including, among others: • bempedoic acid and the bempedoic acid / ezetimibe combination tablet’s demonstrated ability to treat patients for LDL-C lowering, or bempedoic acid and the bempedoic acid / ezetimibe combination tablet’s ability to achieve CV risk reduction, as compared with other available therapies; • the relative convenience and ease of administration of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, including as compared with other treatments for patients for LDL-C lowering or CV risk reduction; • the prevalence and severity of any adverse side effects such as muscle pain or weakness; • limitations or warnings contained in the labeling approved for bempedoic acid or the bempedoic acid / ezetimibe combination tablet by the FDA or other regulatory authorities; • availability of alternative treatments, including a number of competitive therapies already approved for LDL-C lowering or CV risk reduction, including PCSK9 inhibitors, or expected to be commercially launched in the near future; • pricing and cost effectiveness; • the effectiveness of our, in Europe, DSE’s, in certain Asian territories, DS's, and in Japan, Otsuka's, sales and marketing strategies, as well as the effectiveness of any other future collaborators; • our ability to increase awareness of bempedoic acid or the bempedoic acid / ezetimibe combination tablet through marketing efforts; • our ability to obtain sufficient third-party coverage or reimbursement; and • the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
Market acceptance of bempedoic acid and the bempedoic acid / ezetimibe combination tablet will depend on a number of factors, including, among others: • bempedoic acid and the bempedoic acid / ezetimibe combination tablet’s demonstrated ability to treat patients for LDL-C lowering, or bempedoic acid and the bempedoic acid / ezetimibe combination tablet’s ability to achieve CV risk reduction, as compared with other available therapies; • the relative convenience and ease of administration of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, including as compared with other treatments for patients for LDL-C lowering or CV risk reduction; • the prevalence and severity of any adverse side effects such as muscle pain or weakness; 52 Table of Contents • limitations or warnings contained in the labeling approved for bempedoic acid or the bempedoic acid / ezetimibe combination tablet by the FDA or other regulatory authorities; • availability of alternative treatments, including a number of competitive therapies already approved for LDL-C lowering or CV risk reduction, including PCSK9 inhibitors, or expected to be commercially launched in the near future; • pricing and cost effectiveness; • the effectiveness of our, in Europe, DSE’s, in certain Asian territories, DS's, and in Japan, Otsuka's, sales and marketing strategies, as well as the effectiveness of any other of our collaborators or future collaborators; • our ability to increase awareness of bempedoic acid or the bempedoic acid / ezetimibe combination tablet through marketing efforts; • our ability to obtain sufficient third-party coverage or reimbursement; and • the willingness of patients to pay out-of-pocket in the absence of third-party coverage.
Obtaining approval of an NDA or MAA is a complex, lengthy, expensive and uncertain process, and the FDA or EMA may delay, limit or deny approval of bempedoic acid and the bempedoic acid / ezetimibe combination tablet for many reasons, including, among others: • the FDA, EMA or any other regulatory authorities may change their approval policies or adopt new regulations; • the FDA, EMA or any other regulatory authorities may change their approval policies for an LDL-C lowering indication for bempedoic acid and the bempedoic acid / ezetimibe combination tablet if there is a shift in the future standard-of-care for statin intolerant patients with hypercholesterolemia; • the FDA, EMA, or any other regulatory authorities may change their approval policies with regard to a CVD risk reduction indication; • the results of our clinical studies may not meet the level of statistical or clinical significance required by the FDA or EMA for marketing approval; 37 Table of Contents • the magnitude of the treatment effect must also be clinically meaningful along with the drug’s safety for a favorable benefit/risk assessment by the FDA, EMA or any other regulatory agency; • the FDA, EMA or any other regulatory agency may change in the future the number, design, size, duration, patient enrollment criteria, exposure of patients, or conduct or implementation of our clinical studies; • the FDA, EMA or any other regulatory agency may require that we conduct additional clinical studies; • the FDA, EMA or any other regulatory agency may not approve the formulation, specifications or labeling of bempedoic acid and the bempedoic acid / ezetimibe combination tablet; • the CROs, that we retain to conduct our clinical studies may take actions outside of our control that materially adversely impact our clinical studies; • the FDA, EMA or any other regulatory agency may find the data from preclinical studies and clinical studies insufficient to demonstrate that the clinical and other benefits of bempedoic acid and the bempedoic acid / ezetimibe combination tablet outweigh the safety risks; • the FDA, EMA or any other regulatory agency may disagree with our interpretation of data from our preclinical studies and clinical studies; • the FDA, EMA or any other regulatory agency may not accept data generated at our clinical study sites; • if our NDAs are reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our applications or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical studies, limitations in approved labeling or distribution and use restrictions; • the FDA, EMA or any other regulatory agency may require the development of a REMS as a condition of approval or post-approval; or • the FDA, EMA or any other regulatory agency may not approve the manufacturing processes or facilities of third-party manufacturers with which we contract.
Obtaining approval of an NDA or MAA is a complex, lengthy, expensive and uncertain process, and the FDA or EMA may delay, limit or deny approval of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, or any of our future product candidates for many reasons, including, among others: • the FDA, EMA or any other regulatory authorities may change their approval policies or adopt new regulations; • the FDA, EMA or any other regulatory authorities may change their approval policies for an LDL-C lowering indication for bempedoic acid and the bempedoic acid / ezetimibe combination tablet if there is a shift in the future standard-of-care for statin intolerant patients with hypercholesterolemia; • the FDA, EMA, or any other regulatory authorities may change their approval policies with regard to a CVD risk reduction indication; 37 Table of Contents • the results of our clinical studies may not meet the level of statistical or clinical significance required by the FDA or EMA for marketing approval; • the magnitude of the treatment effect must also be clinically meaningful along with the drug’s safety for a favorable benefit/risk assessment by the FDA, EMA or any other regulatory agency; • the FDA, EMA or any other regulatory agency may change in the future the number, design, size, duration, patient enrollment criteria, exposure of patients, or conduct or implementation of our clinical studies; • the FDA, EMA or any other regulatory agency may require that we conduct additional clinical studies; • the FDA, EMA or any other regulatory agency may not approve the formulation, specifications or labeling of bempedoic acid and the bempedoic acid / ezetimibe combination tablet; • the CROs, that we retain to conduct our clinical studies may take actions outside of our control that materially adversely impact our clinical studies; • the FDA, EMA or any other regulatory agency may find the data from preclinical studies and clinical studies insufficient to demonstrate that the clinical and other benefits of bempedoic acid and the bempedoic acid / ezetimibe combination tablet outweigh the safety risks; • the FDA, EMA or any other regulatory agency may disagree with our interpretation of data from our preclinical studies and clinical studies; • the FDA, EMA or any other regulatory agency may not accept data generated at our clinical study sites; • if our NDAs are reviewed by an advisory committee, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our applications or may recommend that the FDA require, as a condition of approval, additional preclinical studies or clinical studies, limitations in approved labeling or distribution and use restrictions; • the FDA, EMA or any other regulatory agency may require the development of a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval or post-approval; or • the FDA, EMA or any other regulatory agency may not approve the manufacturing processes or facilities of third-party manufacturers with which we contract.
If DSE, Otsuka, DS and our current or future collaboration partners fail to develop or effectively commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet for any of these reasons, our sales of bempedoic acid or the bempedoic acid / ezetimibe combination tablet may be limited, which would have a material adverse effect on our operating results and financial condition. 71 Table of Contents 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.
If DSE, Otsuka, DS and our current or future collaboration partners fail to develop or effectively commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet for any of these reasons, our sales of bempedoic acid or the bempedoic acid / ezetimibe combination tablet may be limited, which would have a material adverse effect on our operating results and financial condition. 76 Table of Contents 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.
Lipid lowering and cardiovascular risk reducing therapies currently on the market that compete with bempedoic acid and the bempedoic acid / ezetimibe combination tablet include the following: • Inexpensive generic versions of statins; • Inexpensive generic versions of ezetimibe, a cholesterol absorption inhibitor; • Injectable PCSK9 inhibitors such as Praluent® (alirocumab) and Repatha® (evolocumab), marketed by Regeneron/Sanofi and Amgen Inc. respectively; • Bile acid sequestrants such as Welchol® (colesevelam), marketed by Daiichi Sankyo Inc.; • MTP inhibitors, such as JUXTAPID® (lomitapide), marketed by Amryt Pharma Plc.; • Apo B Anti-Sense therapy, such as KYNAMRO® (mipomersen), marketed by Kastle Therapeutics LLC; • Inexpensive generic versions of combination tablet therapies, such as ezetimibe and simvastatin; • Triglyceride lowering therapy such as Vascepa® (icosapent ethyl), marketed by Amarin Corporation; • Small interfering RNA therapy, such as Leqvio® (inclisiran), marketed by Novartis; and 49 Table of Contents • Other lipid-lowering monotherapies (including cheaper generic versions), such as Tricor® (fenofibrate) and Niaspan® (niacin extended release), both of which are marketed by AbbVie, Inc.
Lipid lowering and cardiovascular risk reducing therapies currently on the market that compete with bempedoic acid and the bempedoic acid / ezetimibe combination tablet include the following: • Inexpensive generic versions of statins; • Inexpensive generic versions of ezetimibe, a cholesterol absorption inhibitor; • Injectable PCSK9 inhibitors such as Praluent® (alirocumab) and Repatha® (evolocumab), marketed by Regeneron/Sanofi and Amgen Inc. respectively; • Bile acid sequestrants such as Welchol® (colesevelam), marketed by Daiichi Sankyo Inc.; • MTP inhibitors, such as JUXTAPID® (lomitapide), marketed by Amryt Pharma Plc.; • Apo B Anti-Sense therapy, such as KYNAMRO® (mipomersen), marketed by Kastle Therapeutics LLC; • Inexpensive generic versions of combination tablet therapies, such as ezetimibe and simvastatin; • Triglyceride lowering therapy such as Vascepa® (icosapent ethyl), marketed by Amarin Corporation; • Small interfering RNA therapy, such as Leqvio® (inclisiran), marketed by Novartis; and • Other lipid-lowering monotherapies (including cheaper generic versions), such as Tricor® (fenofibrate) and Niaspan® (niacin extended release), both of which are marketed by AbbVie, Inc.
Bempedoic acid and the bempedoic acid / ezetimibe combination tablet will also be subject to ongoing FDA requirements governing the packaging, storage, labeling, advertising and promotion of the product, recordkeeping and submission of safety updates and other post-marketing information.
Bempedoic acid and the bempedoic acid / ezetimibe combination tablet will also be subject to ongoing FDA requirements governing the packaging, storage, labeling, sampling, advertising and promotion of the product, recordkeeping and submission of safety updates and other post-marketing information.
Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. 69 Table of Contents 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.
Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. 74 Table of Contents 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.
Inadequate funding for the FDA, the SEC and other 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.
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.
Our complaints allege that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL's and/or NEXLIZET's Orange Book patents, as applicable, included in its Paragraph IV certifications, and seek an injunction preventing FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL and/or NEXLIZET, as applicable, until the expiration of the asserted patents.
The Company’s complaints allege that by filing the applicable ANDA, such ANDA Filer has infringed NEXLETOL’s and/or NEXLIZET’s Orange Book patents, as applicable, included in its Paragraph IV certifications, and seek an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents, and a permanent injunction to prevent the ANDA Filer from commercializing a generic version of NEXLETOL and/or NEXLIZET, as applicable, until the expiration of the asserted patents.
The U.S. Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA, on which we rely.
Supreme Court’s June 2024 decision in Loper Bright Enterprises v. Raimondo overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes. The Loper decision could result in additional legal challenges to regulations and guidance issued by federal agencies, including the FDA, on which we rely.
Significant civil monetary penalties also can be applied if we are found to 45 Table of Contents have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price. We cannot assure you that our submissions will not be found by CMS or HRSA to be incomplete or incorrect.
Significant civil monetary penalties also can be applied if we are found to 46 Table of Contents have knowingly and intentionally charged 340B covered entities more than the statutorily mandated ceiling price. We cannot assure you that our submissions will not be found by CMS or HRSA to be incomplete or incorrect.
While we have commercially launched our approved drugs in the U.S. and DSE and DS have commercially launched in multiple countries in the EU and Asia, we have limited experience as a commercial company and there is limited information about our ability to successfully overcome many of the risks and uncertainties encountered by companies commercializing drugs in the biopharmaceutical industry.
While we have commercially launched our approved drugs in the U.S. and DSE, DS, and Otsuka have collectively commercially launched in multiple countries in the EU and Asia, we have limited experience as a commercial company and there is limited information about our ability to successfully overcome many of the risks and uncertainties encountered by companies commercializing drugs in the biopharmaceutical industry.
Furthermore, in March, April, June and August 2024, we received notices from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL and four of which filed with respect to NEXLETOL and NEXLIZET (each, an “ANDA Filer”), that each company had filed an ANDA, with the FDA seeking approval of a generic version of NEXLETOL and/or NEXLIZET, as applicable.
Furthermore, in March, April, June and August 2024, we received notices from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL and four of which filed with respect to NEXLETOL and NEXLIZET, that each company had filed an ANDA, with the FDA seeking approval of a generic version of NEXLETOL and/or NEXLIZET, as applicable.
If that were to occur, we may have to curtail the development or delay commercialization of bempedoic acid or the bempedoic acid / ezetimibe combination tablet in certain geographies, reduce the scope of our sales or marketing activities, 61 Table of Contents reduce the scope of our commercialization plans, or increase our expenditures and undertake development or commercialization activities at our own expense.
If that were to occur, we may have to curtail the development or delay commercialization of bempedoic acid or the bempedoic acid / ezetimibe combination tablet in certain geographies, reduce the scope of our sales or marketing activities, 66 Table of Contents reduce the scope of our commercialization plans, or increase our expenditures and undertake development or commercialization activities at our own expense.
For example, it could: • make us more vulnerable to adverse changes in general U.S. and worldwide economic, industry and competitive conditions and adverse changes in government regulation; 63 Table of Contents • limit our flexibility in planning for, or reacting to, changes in our business and our industry; • place us at a disadvantage compared to our competitors who have less debt; • limit our ability to borrow additional amounts to fund acquisitions, for working capital and for other general corporate purposes; and • make an acquisition of our company less attractive or more difficult.
For example, it could: • make us more vulnerable to adverse changes in general U.S. and worldwide economic, industry and competitive conditions and adverse changes in government regulation; • limit our flexibility in planning for, or reacting to, changes in our business and our industry; • place us at a disadvantage compared to our competitors who have less debt; • limit our ability to borrow additional amounts to fund acquisitions, for working capital and for other general corporate purposes; and • make an acquisition of our company less attractive or more difficult.
Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them.
Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them. Item 1B.
The conduct and completion of any of our future clinical studies can be delayed or prevented for a number of reasons, including, among others: • the FDA, EMA or any other regulatory authority may not agree to the study design or overall program; • the FDA, EMA or any other regulatory authority may place a clinical study on hold; • delays in reaching or failing to reach agreement on acceptable terms with prospective CROs and study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites; • inadequate quantity or quality of a product candidate or other materials necessary to conduct clinical studies; • difficulties or delays obtaining IRB, approval to conduct a clinical study at a prospective site or sites; • severe or unexpected drug-related side effects experienced by patients in a clinical study, including instances of muscle pain or weakness or other side effects; • reports from preclinical or clinical testing of other cardiometabolic therapies that raise safety or efficacy concerns; and 55 Table of Contents • difficulties retaining patients who have enrolled in a clinical study but may be prone to withdraw due to rigors of the study, lack of efficacy, side effects, personal issues or loss of interest.
The conduct and completion of any of our future clinical studies can be delayed or prevented for a number of reasons, including, among others: • the FDA, EMA or any other regulatory authority may not agree to the study design or overall program; • the FDA, competent authorities in the EU or any other regulatory authority may place a clinical study on hold; • delays in reaching or failing to reach agreement on acceptable terms with prospective CROs and study sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and study sites; • inadequate quantity or quality of a product candidate or other materials necessary to conduct clinical studies; • difficulties or delays obtaining IRB, approval to conduct a clinical study at a prospective site or sites; • severe or unexpected drug-related side effects experienced by patients in a clinical study, including instances of muscle pain or weakness or other side effects; • reports from preclinical or clinical testing of other cardiometabolic therapies that raise safety or efficacy concerns; and • difficulties retaining patients who have enrolled in a clinical study but may be prone to withdraw due to rigors of the study, lack of efficacy, side effects, personal issues or loss of interest.
Our independent registered public accounting firm did issue a report on the effectiveness of our internal controls over financial reporting for the year ended December 31, 2024, which is included in Item 9A "Controls and Procedures" on this Annual Report on 10-K.
Our independent registered public accounting firm did issue a report on the effectiveness of our internal controls over financial reporting for the year ended December 31, 2025, which is included in Item 9A "Controls and Procedures" on this Annual Report on 10-K.
We may also enter into similar arrangements with other partners or collaborators to commercialize bempedoic acid and the bempedoic acid / ezetimibe combination tablet, outside of the United States, Europe, Japan, or the DS Territory, or to further commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet in the broader cholesterol modifying market in the United States.
We have entered and may also enter into similar arrangements with other partners or collaborators to commercialize bempedoic acid and the bempedoic acid / ezetimibe combination tablet, outside of the United States, Europe, Japan, or the DS Territory, or to further commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet in the broader cholesterol modifying market in the United States.
The listing requirements of the NASDAQ Global Market require that we satisfy certain corporate governance requirements relating to director independence, distributing annual and interim reports, stockholder meetings, approvals and voting, soliciting proxies, conflicts of interest and a code of conduct.
The listing requirements of the NASDAQ Capital Market require that we satisfy certain corporate governance requirements relating to director independence, distributing annual and interim reports, stockholder meetings, approvals and voting, soliciting proxies, conflicts of interest and a code of conduct.
Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any other product candidate.
Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any other product candidates.
We may, however, need to secure additional cash resources to continue to fund the 60 Table of Contents commercialization and further clinical development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any other product candidate.
We may, however, need to secure additional cash resources to continue to fund the 65 Table of Contents commercialization and further clinical development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any other product candidate.
If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes or make cash payments upon conversions. In addition, our indebtedness, combined with our other financial obligations and contractual commitments, could have other important consequences.
If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes or make cash payments upon conversions. 68 Table of Contents In addition, our indebtedness, combined with our other financial obligations and contractual commitments, could have other important consequences.
Any delay in or inability to complete our clinical studies could significantly compromise our ability to secure regulatory approval of bempedoic acid or the bempedoic acid / ezetimibe combination tablet for additional indications we may seek and preclude our ability to commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet, thereby limiting or preventing our ability to generate revenue from its sales. 72 Table of Contents We rely completely on third-party suppliers to manufacture our clinical drug supplies for bempedoic acid and the bempedoic acid / ezetimibe combination tablet and 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.
Any delay in or inability to complete our clinical studies could significantly compromise our ability to secure regulatory approval of bempedoic acid or the bempedoic acid / ezetimibe combination tablet for additional indications we may seek and preclude our ability to commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet, thereby limiting or preventing our ability to generate revenue from its sales. 77 Table of Contents 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.
We anticipate that we will encounter intense and increasing competition as new drugs enter the market and advanced technologies become available. 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.
We anticipate that we will encounter intense and increasing competition as new drugs enter the market and advanced technologies become available. 51 Table of Contents 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.
Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected. 75 Table of Contents If securities or industry analysts cease publishing research or reports or publish misleading, inaccurate or unfavorable research about us, our business or our market, our stock price and trading volume could decline.
Accordingly, because of the inherent limitations in our control system, misstatements due to error or fraud may occur and not be detected. If securities or industry analysts cease publishing research or reports or publish misleading, inaccurate or unfavorable research about us, our business or our market, our stock price and trading volume could decline.
In addition, a clinical study may be suspended or terminated by us, the FDA, the EMA, the IRBs at the sites where the IRBs are overseeing a clinical study, a data safety monitoring committee, or DMC, overseeing the clinical study at issue or any other regulatory authorities due to a number of factors, including, among others: • failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols; • inspection of the clinical study operations or study sites by the FDA, EMA or any other regulatory authorities that reveals deficiencies or violations that require us to undertake corrective action, including the imposition of a clinical hold; • unforeseen safety issues; • changes in government regulations or administrative actions; • problems with clinical supply materials; and • lack of adequate funding to continue the clinical study.
In addition, a clinical study may be suspended or terminated by us, the FDA, the EMA, the IRBs at the sites where the IRBs are overseeing a 58 Table of Contents clinical study, a data safety monitoring committee, or DMC, overseeing the clinical study at issue or any other regulatory authorities due to a number of factors, including, among others: • failure to conduct the clinical study in accordance with regulatory requirements or our clinical protocols; • inspection of the clinical study operations or study sites by the FDA, competent authorities in the EU or any other regulatory authorities that reveals deficiencies or violations that require us to undertake corrective action, including the imposition of a clinical hold; • unforeseen safety issues; • changes in government regulations or administrative actions; • problems with clinical supply materials; and • lack of adequate funding to continue the clinical study.
We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks, including costs to deploy additional personnel and protection technologies, train employees, and engage third-party experts and consultants, which could materially and adversely affect our business, financial condition and results of operations.
We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks, including costs to deploy additional personnel and protection technologies, train employees, notify impacted individuals and engage third-party experts and consultants, which could materially and adversely affect our business, financial condition and results of operations.
Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, including as a result of interactions with alcohol or other drugs, negligence, strict liability, and a breach of warranties. Claims could also be asserted under state consumer protection acts.
Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, including as a result of interactions with alcohol or other drugs, negligence, strict liability, 62 Table of Contents and a breach of warranties. Claims could also be asserted under state consumer protection acts.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current macroeconomic and geopolitical climate and financial market conditions could adversely impact our business. The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
Any time, effort and financial resources we expend on any early-stage development programs that we may pursue may adversely affect our ability to continue development and commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, and we may never commence clinical studies of such development programs despite expending significant resources in pursuit of their development.
Any time, effort and financial resources we expend on any early-stage development programs that we may pursue may adversely affect our ability to continue development and commercialization of 61 Table of Contents bempedoic acid and the bempedoic acid / ezetimibe combination tablet, and we may never commence clinical studies of such development programs despite expending significant resources in pursuit of their development.
Furthermore, the issuance of a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide us with adequate proprietary protection or competitive advantages against competitors with similar products. Competitors may also be able to design around our patents.
Furthermore, the issuance of a patent, while presumed valid and enforceable, is not conclusive as to its validity or its enforceability and it may not provide us with adequate proprietary protection or competitive advantages against competitors 72 Table of Contents with similar products. Competitors may also be able to design around our patents.
Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business. The failure to comply with any of these laws or regulatory requirements subjects entities to possible legal or regulatory action.
Ensuring business arrangements comply 43 Table of Contents with applicable healthcare laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from the business. The failure to comply with any of these laws or regulatory requirements subjects entities to possible legal or regulatory action.
Competition that NEXLETOL or NEXLIZET could face from an approved generic and other versions of NEXLETOL or NEXLIZET could materially and adversely affect our future revenue, profitability, and cash flows and substantially limit our ability to obtain a return on the investments we have 41 Table of Contents made in developing NEXLETOL and NEXLIZET.
Competition that NEXLETOL or NEXLIZET could face from an approved generic and other versions of NEXLETOL or NEXLIZET could materially and adversely affect our future revenue, profitability, and cash flows and substantially limit our ability to obtain a return on the investments we have made in developing NEXLETOL and NEXLIZET.
If we, our vendors, or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative artificial intelligence, we may lose 48 Table of Contents valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed.
If we, our vendors, or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative artificial intelligence, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed.
We may rely on sole source third-party suppliers to manufacture and supply bempedoic acid and the bempedoic acid / ezetimibe combination tablet which may not be able to produce sufficient inventory to meet commercial demand in a cost-efficient, timely manner, or at all.
We may rely on sole source third-party suppliers to manufacture and supply bempedoic acid, the bempedoic acid / ezetimibe combination tablet, or future drug candidates which may not be able to produce sufficient inventory to meet commercial demand in a cost-efficient, timely manner, or at all.
We expect that our existing cash and cash equivalents and proceeds to be received in the future for product sales and under our collaboration agreements are sufficient to fund operations for the near term future. We may look to secure additional cash resources should positive corporate events or milestones provide sufficient opportunities.
We expect that our existing cash and cash equivalents and proceeds to be received in the future for product sales and under our collaboration agreements are sufficient to fund operations for the foreseeable future. We may look to secure additional cash resources should positive corporate events or milestones provide sufficient opportunities.
Similarly, adverse market or macroeconomic conditions or market volatility resulting from global economic developments, geopolitical developments, high inflation, rising interest rates, international tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions, future public health epidemics or other factors, could materially and adversely affect our ability to consummate an equity or debt financing on favorable terms, or at all.
Similarly, adverse market or macroeconomic conditions or market volatility resulting from national or global economic developments, geopolitical developments, high inflation, rising interest rates, new or increased international tariffs and retaliatory tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions, future public health epidemics or other factors, could materially and adversely affect our ability to consummate an equity or debt financing on favorable terms, or at all.
Additionally, we are obligated to maintain proper and effective internal control over financial reporting. If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors' views of us and, as a result, the value of our common stock.
If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors' views of us and, as a result, the value of our common stock.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from 53 Table of Contents liabilities, damages, or claims related to our privacy and data security obligations.
Our contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in our contracts are sufficient to protect us from liabilities, damages, or claims related to our privacy and data security obligations.
A loss of key personnel or their work product could hamper or prevent our ability to commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet, which would materially adversely affect our commercial development efforts. 59 Table of Contents 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 near term future.
A loss of key personnel or their work product could hamper or prevent our ability to commercialize bempedoic acid or the bempedoic acid / ezetimibe combination tablet, which would materially adversely affect our commercial development efforts. 64 Table of Contents 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.
NILEMDO and NUSTENDI are the branded product names for bempedoic acid and the bempedoic acid / ezetimibe combination tablet in Europe. Since 2020, Daiichi Sankyo Europe launched NILEMDO and NUSTENDI in multiple EU countries including the UK, Switzerland. Daiichi Sankyo Europe also received approvals for NILEMDO and NUSTENDI in Turkey for LDL-C lowering.
NILEMDO and NUSTENDI are the branded product names for bempedoic acid and the bempedoic acid / ezetimibe combination tablet in Europe. Since 2020, Daiichi Sankyo Europe launched NILEMDO and NUSTENDI in multiple EU countries as well as the UK and, Switzerland. Daiichi Sankyo Europe also received approvals for NILEMDO and NUSTENDI in Turkey for LDL-C lowering.
We may encounter delays or hurdles related to our launches that affect timing. Our business currently depends heavily on our ability to successfully commercialize NEXLETOL and NEXLIZET in the U.S. to treat patients for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients.
We may encounter delays or hurdles related to our launches that affect timing. 36 Table of Contents Our business currently depends heavily on our ability to successfully commercialize NEXLETOL and NEXLIZET in the U.S. to treat patients for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients.
In some cases, we rely upon the EC's approved standard contractual clauses, or the SCCs to legitimize transfers of personal data out of the EEA from controllers or processors established outside the EEA (and not subject to the GDPR).
In some cases, we rely upon the EC's approved standard contractual clauses, or the SCCs to legitimize transfers of personal data out of the EEA from controllers or processors 47 Table of Contents established outside the EEA (and not subject to the GDPR).
In April 2021, we entered into a license and collaboration agreement with DS, pursuant to which DS will be responsible for the commercialization of bempedoic acid and the bempedoic 70 Table of Contents acid / ezetimibe combination in South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, Macao, Cambodia and Myanmar, or the DS Territory.
In April 2021, we entered into a license and collaboration agreement with DS, pursuant to which DS will be responsible for the commercialization of bempedoic acid and the bempedoic acid / 75 Table of Contents ezetimibe combination in South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, and Macao, or the DS Territory.
At December 31, 2024, our executive officers, directors, combined with our stockholders who own more than 5% of our outstanding capital stock, and entities affiliated with certain of our directors beneficially owned approximately 36% of our outstanding voting common stock. These stockholders have the ability to influence us through their ownership position.
At December 31, 2025, our executive officers, directors, combined with our stockholders who own more than 5% of our outstanding capital stock, and entities affiliated with certain of our directors beneficially owned approximately 15% of our outstanding voting common stock. These stockholders have the ability to influence us through their ownership position.
However, any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request.
However, any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant shorter extensions than we request.
If we are unable to obtain adequate financing or financing on terms satisfactory to us, we could face significant limitations on our ability to invest in our operations and otherwise suffer harm to our business. 52 Table of Contents Adverse developments affecting the financial services industry could have an adverse effect on our operations and financial results.
If we are unable to obtain adequate financing or financing on terms satisfactory to us, we could face significant limitations on our ability to invest in our operations and otherwise suffer harm to our business. Adverse developments affecting the financial services industry could have an adverse effect on our operations and financial results.
Foreign CROs may be subject to U.S. legislation or investigations, including legislation similar to the previously proposed BIOSECURE Act, sanctions, trade restrictions and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials, have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies and could adversely affect our financial condition and business prospects.
Foreign CROs may be subject to U.S. legislation or investigations, sanctions, trade restrictions and other foreign regulatory requirements, which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material, delay or impact clinical trials, have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies and could adversely affect our financial condition and business prospects.
In general, an “ownership change” will occur if there is a cumulative change in our ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws.
In general, an “ownership 56 Table of Contents change” will occur if there is a cumulative change in our ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws.
We may never be able to successfully commercialize the products even with their expanded indications or meet our 36 Table of Contents expectations with respect to revenues. Prior to our launch in March 2020, we had never marketed, sold or distributed for commercial use any pharmaceutical product.
We may never be able to successfully commercialize the products even with their expanded indications or meet our expectations with respect to revenues. Prior to our launch in March 2020, we had never marketed, sold or distributed for commercial use any pharmaceutical product.
Federal and state enforcement bodies 42 Table of Contents often scrutinize interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.
Federal and state enforcement bodies often scrutinize interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.
We have obtained regulatory approval from Health Authorities in Turkey, Hong Kong, Thailand, Myanmar, Macau for LDL-C lowering for both products and from Taiwan TFDA for NILEMDO.
We have obtained regulatory approval from Health Authorities in Turkey, Hong Kong, Thailand, Myanmar, Macau for LDL-C lowering for both products and from Taiwan TFDA, Japan MHLW, and Health Canada for NILEMDO.
As a public company, we have incurred and will continue to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur operating losses for the near term future.
As a public company, we have incurred and will continue to incur additional costs associated with operating as a public company. As a result, we expect to continue to incur operating losses for the immediate future.
On February 21, 2023, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent, to provide for the issuance and sale by us of up to $70 million of shares of our common stock from time to time in “at-the-market” offerings, or the 2023 ATM Program, pursuant to our existing Form S-3 and the prospectus supplement filed on February 21, 2023 .
On February 21, 2023, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent, to provide for the issuance and sale by us of up to $70 million of shares of our common stock from time to time in “at-the-market” offerings, or the 2023 ATM Program, pursuant to our existing Form S-3, including the sales agreement prospectus contained therein, filed on April 18, 2025 .
The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
The stock market in general and the market for pharmaceutical and biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies.
Significant changes in government spending or changes in U.S. government priorities, policies and requirements could have a material adverse effect on our results of operations, financial condition or liquidity. Unfavorable macroeconomic conditions or market volatility resulting from global economic conditions, including those affecting the financial services industry, could adversely affect our business, financial condition or results of operations.
Significant changes in government spending or changes in U.S. government priorities, policies and requirements could have a material adverse effect on our results of operations, financial condition or liquidity. 82 Table of Contents Unfavorable macroeconomic conditions or market volatility resulting from geopolitical developments or national or global economic conditions, including those affecting the financial services industry, could adversely affect our business, financial condition or results of operations.
Our net losses were $51.7 million, $209.2 million, and $233.7 million for the years ended December 31, 2024, 2023, and 2022, respectively. As of December 31, 2024, we had an accumulated deficit of $1.6 billion.
Our net losses were $22.7 million, $51.7 million, and $209.2 million for the years ended December 31, 2025, 2024, and 2023, respectively. As of December 31, 2025, we had an accumulated deficit of $1.6 billion.
Congress of a new comprehensive federal data privacy law to which we could become subject, if enacted. Regulators and legislators in the U.S. are also increasingly scrutinizing and restricting certain personal data transfers and transactions involving foreign countries.
Congress of a new comprehensive federal data privacy law to which we could become subject, if such laws are enacted. 48 Table of Contents Regulators and legislators in the U.S. are also increasingly scrutinizing and restricting certain personal data transfers and transactions involving foreign countries.
In addition, Otsuka will fund all clinical development costs associated with the program in Japan, if approved.
In addition, Otsuka will fund all clinical development costs associated with the program in Japan.
Bempedoic acid and the bempedoic acid / ezetimibe combination tablet may require substantial additional clinical development, testing, and regulatory approvals before we are permitted to commence their commercialization in markets outside of the U.S. and Europe for an LDL-C lowering or cardiovascular risk reduction indication.
Bempedoic acid and the bempedoic acid / ezetimibe combination tablet may require substantial additional clinical development, testing, and regulatory approvals before we are permitted to commence their commercialization in markets outside of the U.S. and Europe and other countries where we have received approval for an LDL-C lowering or cardiovascular risk reduction indication.
Failure to succeed in clinical studies may make it more challenging to recruit and retain qualified scientific personnel. Risks Related to Sales, Marketing, and Competition Our market is subject to intense competition.
Failure to succeed in clinical studies may make it more challenging to recruit and retain qualified scientific personnel. 50 Table of Contents Risks Related to Sales, Marketing, and Competition Our market is subject to intense competition.
If we, bempedoic acid or the bempedoic acid / ezetimibe combination tablet or the manufacturing facilities for bempedoic acid or the bempedoic acid / ezetimibe combination tablet fail to comply with applicable regulatory requirements, a regulatory agency may, among other things: • issue warning letters or untitled letters; • seek an injunction or impose civil or criminal penalties or monetary fines; • suspend or withdraw marketing approval; • suspend any ongoing clinical studies; • refuse to approve pending applications or supplements to applications submitted by us; • suspend or impose restrictions on operations, including costly new manufacturing requirements; or • seize or detain products, refuse to permit the import or export of products, or request that we initiate a product recall.
If we, the bempedoic acid product or the bempedoic acid / ezetimibe combination tablet, or future product candidates, or the manufacturing facilities for such products fail to comply with applicable regulatory requirements, a regulatory agency may, among other things: • issue FDA Forms 483s, warning letters or untitled letters; • seek an injunction or impose civil or criminal penalties or monetary fines; • suspend or withdraw marketing approval; • suspend any ongoing clinical studies; • refuse to approve pending applications or supplements to applications submitted by us; • suspend or impose restrictions on operations, including costly new manufacturing requirements; or • seize or detain products, refuse to permit the import or export of products, or request that we initiate a product recall. 40 Table of Contents The U.S.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such products (or any other similar products) after such approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may withdraw or limit their approval of such products; • regulatory authorities may require the addition of labeling statements, such as a “boxed” warning or a contraindication; • we may be required to change the way such products are distributed or administered, conduct additional clinical trials or change the labeling of the products; • we may be subject to regulatory investigations and government enforcement actions; 56 Table of Contents • we may decide to recall or remove such products from the marketplace; or • we could be sued and held liable for injury caused to individuals exposed to or taking our products and product candidates; and our reputation may suffer.
If our product candidates receive marketing approval and we or others identify undesirable side effects caused by such products (or any other similar products) after such approval, a number of potentially significant negative consequences could result, including: • regulatory authorities may suspend, withdraw or limit their approval of such products; • regulatory authorities may require the addition or modification of labeling statements, such as a “boxed” warning or a contraindication, or the issuance of additional “Dear Doctor Letters” or similar communications to healthcare professionals; • we may be required to change the way such products are distributed or administered, conduct post-marketing surveillance, conduct additional clinical trials or change the labeling of the products; • we may be subject to regulatory investigations and government enforcement actions; • we may decide to recall or remove such products from the marketplace; or 59 Table of Contents • we could be sued and held liable for injury caused to individuals exposed to or taking our products and product candidates; and our reputation may suffer.
In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
In addition, government funding of the SEC and other U.S. government agencies on which our operations may rely, including those that fund research and development activities, is subject to the political process, including executive and congressional priorities, which is inherently fluid and unpredictable.
Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income may be limited.
Additionally, under Sections 382 and 383 of the U.S. Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income may be limited.
Since the launch of our products, we have generated $302.9 million in net revenue from product sales in the U.S. We have obtained regulatory approval for both products from the FDA in the U.S., the EC in Europe and Swissmedic in Switzerland as well as from regulatory authorities in several Asian territories.
Since the launch of our products, we have generated $462.5 million in net revenue from product sales in the U.S. We have obtained regulatory approval for both products from the FDA in the U.S., the EC in the EU and Swissmedic in Switzerland as well as from regulatory authorities in several Asian territories.
Sanctions imposed by the U.S. and other countries in response to such conflicts, including the one in Ukraine, may also continue to adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability.
Sanctions imposed by the U.S. and other countries in response to such conflicts may also continue to adversely impact the financial markets and the global economy, and any economic countermeasures by the affected countries or others could exacerbate market and economic instability. Tariffs levied by the U.S. and other countries also may adversely affect financial markets and the global economy.
In 2024, we generated $115.7 million in net revenues from the sale of products in the U.S. Our products, NEXLETOL (bempedoic acid) tablet and NEXLIZET (bempedoic acid and ezetimibe) tablet, were approved by the FDA in February 2020. NEXLETOL became commercially available in the U.S. in March 2020 and NEXLIZET became commercially available in the U.S. in June 2020.
In 2025, we generated $159.6 million in net revenues from the sale of products in the U.S. Our products, NEXLETOL (bempedoic acid) tablet and NEXLIZET (bempedoic acid and ezetimibe) tablet, were approved by the FDA in February 2020. NEXLETOL became commercially available in the U.S. in March 2020 and NEXLIZET became commercially available in the U.S. in June 2020.
While we have not experienced any such material system failure, accident, or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs.
While we have not experienced any such material system failure, accident, cybersecurity incidents or data breaches to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs.
The annual limitation may result in the expiration of net operating losses or credit carryforwards before utilization. As of result of stock transactions, we expect the Company experienced an ownership change in 2013, 2017, 2021, 2023 and 2024. We may also experience ownership changes in the future as a result of future transactions in our stock.
The annual limitation may result in the expiration of net operating losses or credit carryforwards before utilization. As of result of stock transactions, we expect the Company experienced an ownership change in 2013, 2017, 2021, 2023 and 2024.
Patent No. 11,116,739, one pending U.S. patent application, and 12 granted patents and 11 pending applications outside the U.S., with claims directed to fixed dose combinations of bempedoic acid and one or more statins and/or methods of using said fixed dose combinations. U.S. Patent No. 11,116,739 is scheduled to expire in March 2036.
Patent No. 11,116,739, one pending U.S. patent application, and 13 granted patents and 9 pending applications outside the U.S., directed to fixed dose combinations of bempedoic acid and one or more statins and/or methods of using such fixed dose combinations. U.S. Patent No. 11,116,739 is scheduled to expire in March 2036.
We do not currently own or operate manufacturing facilities for the production of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any future drug candidates that may be approved in the future.
We do not currently own or operate manufacturing facilities for the production of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any future drug candidates or future approved drugs.
Our research and development expenses are expected to increase slightly in 2025 due to the start of our pediatric phase III trial and ongoing preclinical pipeline work. We expect to continue to incur research and development expenses as they relate to any other early-stage development programs or additional indications we choose to pursue.
Our research and development expenses are expected to remain consistent in 2026 due to the continuation of our pediatric phase III trial and ongoing preclinical pipeline work. We expect to continue to incur research and development expenses as they relate to any other early-stage development programs or additional indications we choose to pursue.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeOur third party vendors may also experience threats and cybersecurity incidents from time to time. For more information, please refer to Item 1A, “Risk Factors,” in this Annual Report on Form 10-K.
Biggest changeOur third party vendors may also experience threats and cybersecurity 84 Table of Contents incidents from time to time. For more information, please refer to Item 1A, “Risk Factors,” in this Annual Report on Form 10-K.
The Director of IT reports to our management – currently the Chief Business Officer. The IT Director meets with the Chief Financial Officer, the Chief Compliance Officer, and the General Counsel periodically to monitor and review the outcomes of our cybersecurity program and to discuss and decide matters related to cybersecurity treatment strategy (including mitigations).
The IT Director reports to our management – currently the Chief Business Officer. The IT Director meets with the Chief Financial Officer, the Chief Compliance Officer, and the General Counsel periodically to monitor and review the outcomes of our cybersecurity program and to discuss and decide matters related to cybersecurity treatment strategy (including mitigations).
Governance Related to Cybersecurity Risks Our cybersecurity program and related operations and processes are directed by our Executive Director of Information Technology, whom we refer to as the IT Director. Currently, the IT Director role is held by an individual who has over 16 years of cybersecurity, information technology, and systems engineering experience.
Governance Related to Cybersecurity Risks Our cybersecurity program and related operations and processes are directed by our Executive Director of Information Technology, whom we refer to as the IT Director. Currently, the IT Director role is held by an individual who has over 17 years of cybersecurity, information technology, and systems engineering experience.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

10 edited+11 added−1 removed6 unchanged
Biggest changeIn the future, we may become party to legal matters and claims arising in the ordinary course of business, the resolution of which we do not anticipate would have a material adverse impact on our financial position, results of operations or cash flows. Item 4. Mine Safety Disclosures Not applicable. 79 Table of Contents PART II
Biggest changeSee "Commitments and Contingencies" under Note 5 to our financial statements included elsewhere in this Annual Report on Form 10‑K for a further discussion of our current legal proceedings. 86 Table of Contents In the future, we may become party to legal matters and claims arising in the ordinary course of business, the resolution of which we do not anticipate would have a material adverse impact on our financial position, results of operations or cash flows.
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 has was subsequently dismissed.
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.
ANDA Litigation Starting in March 2024, the Company received notices from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL and four of which filed with respect to NEXLETOL and NEXLIZET (each, an “ANDA Filer”), notifying the Company that each company had filed an Abbreviated New Drug Application, or ANDA, with the FDA seeking approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
ANDA Litigation Starting in March 2024, the Company received notices from nine pharmaceutical companies, six of which filed exclusively with respect to NEXLETOL and four of which filed with respect to NEXLETOL and NEXLIZET (each, an “ANDA Filer”), notifying the Company that each company had filed an Abbreviated New Drug Application ("ANDA") with the FDA seeking 85 Table of Contents approval of a generic version of NEXLETOL and/or NEXLIZET in the United States, as applicable.
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 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.
Under the Hatch-Waxman Act to the FDCA, the Company had 45 days from receipt of the notice letters to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court to trigger a stay precluding the FDA’s approval of any ANDA from being effective any earlier than 7.5 years from the date of approval of the NEXLETOL or NEXLIZET, as applicable, NDA or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.
Under the Hatch-Waxman Act to the Federal Food, Drug, and Cosmetic Act ("FDCA"), the Company had 45 days from receipt of the notice letters to commence patent infringement lawsuits against these generic drug manufacturers in a federal district court to trigger a stay precluding the FDA’s approval of any ANDA from being effective any earlier than 7.5 years from the date of approval of the NEXLETOL or NEXLIZET, as applicable, new drug application or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.
Beginning in May 2024, the Company filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against each ANDA Filer: Accord Healthcare Inc.; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with an affiliate); Dr. Reddy’s Laboratories Inc. (along with an affiliate); Hetero USA Inc. (along with affiliates); Micro Labs USA Inc.
Beginning in May 2024, the Company filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against each ANDA Filer: Accord Healthcare Inc.; Alkem Laboratories Ltd.; Aurobindo Pharma Limited (along with its affiliate); Dr. Reddy’s Laboratories Inc. (along with its affiliate, collectively, “Dr. Reddy’s Laboratories”); Hetero USA Inc.
The DSE Amendment and the DS Amendment grant each of DSE and DS exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in their existing respective territories of the European Economic Area, UK, Switzerland and Turkey, or the DSE Territory, and the DS Territory.
The DSE Amendment and the DS Amendment grant each of DSE and DS exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in their existing respective territories of the European Economic Area, UK, Switzerland and Turkey, or the DSE Territory, and South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, and Macao, or the DS Territory.
On June 20, 2023, DSE filed a response to our amended complaint. 78 Table of Contents 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.
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.
(along with an affiliate); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited; and Sandoz Inc.
(along with its affiliates, collectively, “Hetero USA”); Micro Labs USA Inc. (along with its affiliate, collectively, “Micro Labs”); MSN Pharmaceuticals Inc. (along with an affiliate); Renata Limited (“Renata”); and Sandoz Inc.
The trial is anticipated to begin no earlier than January 2027, but no trial date has been set. We are currently involved, as we are from time to time, in legal proceedings that arise in the ordinary course of our business.
No trial date has been set. We are currently involved, as we are from time to time, in legal proceedings that arise in the ordinary course of our business. We believe that we have adequately accrued for these liabilities and that there is no other litigation pending that could materially harm our results of operations and financial condition.
Removed
We believe that we have adequately accrued for these liabilities and that there is no other litigation pending that could materially harm our results of operations and financial condition. See "Commitments and Contingencies" under Note 5 to our financial statements included elsewhere in this Annual Report on Form 10‑K for a further discussion of our current legal proceedings.
Added
The Company subsequently reached settlement agreements with Micro Labs, Hetero USA, Accord Healthcare Inc., Dr. Reddy’s Laboratories, and Alkem Laboratories Ltd. in May 2025, June 2025, July 2025, October 2025, and February 2026, respectively.
Added
Each settlement agreement resolved the patent litigation brought by the Company against the particular ANDA Filer, each of which has agreed not to market a generic version of NEXLETOL and/or NEXLIZET, as applicable, in the United States prior to April 19, 2040, unless certain circumstances customarily included in these types of agreements occur. With the settlement with Dr.
Added
Reddy’s Laboratories in October 2025, there are no remaining challenges regarding the validity or infringement of U.S Patent No. 7,335,799 in the pending patent litigation with the remaining ANDA filers. Certain of the Company’s patents that remain subject to the pending patent litigation are scheduled to expire in March 2036, while others are scheduled to expire in June 2040.
Added
The pending patent litigation against the remaining ANDA Filers (Aurobindo Pharma Limited (along with an affiliate); MSN Pharmaceuticals Inc.
Added
(along with an affiliate); Renata (along with an affiliate); and Sandoz Inc.) is ongoing, and there can be no assurance whether such ongoing patent litigation will allow a generic version of NEXLETOL and/or NEXLIZET, as applicable, to be marketed in the U.S. prior to April 19, 2040.
Added
The trial is anticipated to begin no earlier than January 2027, but no trial date has been set. In January 2026, Renata notified the Company that it had filed an ANDA with the FDA seeking approval of a generic version of NEXLIZET in the United States (the “2026 Renata ANDA”).
Added
The 2026 Renata ANDA is in addition to the ANDA that Renata had previously filed with respect to NEXLETOL, for which the pending patent litigation described above is ongoing.
Added
Under the Hatch-Waxman Act, the Company had 45 days from receipt of the 2026 Renata ANDA notice letter to commence patent infringement lawsuits against Renata in a federal district court to trigger a stay precluding the FDA’s approval of the 2026 Renata ANDA from being effective any earlier than 7.5 years from the date of approval of the NEXLIZET new drug application or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.
Added
In March 2026, the Company filed a patent infringement lawsuit under the Hatch-Waxman Act in the United States District Court, District of New Jersey, against Renata.
Added
The Company’s complaint alleges that by filing the 2026 Renata ANDA, Renata has infringed NEXLIZET’s Orange Book patents included in its Paragraph IV certifications, and seeks an injunction preventing the FDA from granting final approval of the 2026 Renata ANDA before the expiration of the asserted patents, and a permanent injunction to prevent Renata from commercializing a generic version of NEXLIZET until the expiration of the asserted patents.
Added
Item 4. Mine Safety Disclosures Not applicable. 87 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

8 edited+0 added−0 removed7 unchanged
Biggest changeRefer to Note 12 in our audited financial statements appearing elsewhere in this Annual Report on Form 10-K for further information.
Biggest changeIn November 2025, the Company repaid the 2025 notes in full for $54.9 million. Refer to Note 12 in our audited financial statements appearing elsewhere in this Annual Report on Form 10-K for further information.
Equity Compensation Plans The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 11 of Part III of this Annual Report on Form 10-K. 80 Table of Contents Unregistered Securities Sold Within Last 3 Years On December 12, 2024, we entered into privately negotiated exchange and subscription agreements with certain holders of our 4.00% Convertible Senior Subordinated Notes due 2025, or the 2025 Notes, pursuant to which we agreed to issue $100.0 million aggregate principal amount of its 5.75% Convertible Senior Subordinated Notes due 2030, or the 2030 Notes, consisting of (a) approximately $57.5 million principal amount of 2030 Notes, along with approximately $153.4 million in cash, including accrued interest, issued in exchange for approximately $210.1 million principal amount of 2025 Notes, or the Exchange Transaction, and (b) approximately $42.5 million principal amount of 2030 Notes for cash, or the Subscription Transactions, and together with the Exchange Transaction, the Transaction, in each case, pursuant to exemptions from registration under the Securities Act and the rules and regulations thereunder.
Equity Compensation Plans The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 11 of Part III of this Annual Report on Form 10-K. 88 Table of Contents Unregistered Securities Sold Within Last 3 Years On December 12, 2024, we entered into privately negotiated exchange and subscription agreements with certain holders of our 4.00% Convertible Senior Subordinated Notes due 2025, or the 2025 Notes, pursuant to which we agreed to issue $100.0 million aggregate principal amount of its 5.75% Convertible Senior Subordinated Notes due 2030, or the 2030 Notes, consisting of (a) approximately $57.5 million principal amount of 2030 Notes, along with approximately $153.4 million in cash, including accrued interest, issued in exchange for approximately $210.1 million principal amount of 2025 Notes, or the Exchange Transaction, and (b) approximately $42.5 million principal amount of 2030 Notes for cash, or the Subscription Transactions, and together with the Exchange Transaction, the Transaction, in each case, pursuant to exemptions from registration under the Securities Act and the rules and regulations thereunder.
Purchases of Equity Securities by the Issuer and Affiliated Purchasers The Company has not made any repurchases of shares or other units of any class of the Company’s equity securities during the fourth quarter of the fiscal year covered by this Annual Report on Form 10-K. Item 6. [Reserved] Not applicable. 81 Table of Contents
Purchases of Equity Securities by the Issuer and Affiliated Purchasers The Company has not made any repurchases of shares or other units of any class of the Company’s equity securities during the fourth quarter of the fiscal year covered by this Annual Report on Form 10-K. Item 6. [Reserved] Not applicable. 89 Table of Contents
Historical stockholder return is not necessarily indicative of the performance to be expected for any future periods. Comparison of 5 Year Cumulative Total Return* Among Esperion Therapeutics, Inc., the NASDAQ Composite Index and the NASDAQ Biotechnology Index ______________________________________________________________________ * $100 invested on December 31, 2019 in stock or index.
Historical stockholder return is not necessarily indicative of the performance to be expected for any future periods. Comparison of 5 Year Cumulative Total Return* Among Esperion Therapeutics, Inc., the NASDAQ Composite Index and the NASDAQ Biotechnology Index ______________________________________________________________________ * $100 invested on December 31, 2020 in stock or index.
Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return for our common stock since December 31, 2019, to two indices: the NASDAQ Composite Index and the NASDAQ Biotechnology Index.
Performance Graph The following graph illustrates a comparison of the total cumulative stockholder return for our common stock since December 31, 2020, to two indices: the NASDAQ Composite Index and the NASDAQ Biotechnology Index.
The graph set forth below compares the cumulative total stockholder return on an initial investment of $100 in our common stock from December 31, 2019 through December 31, 2024, with the comparative cumulative total return of such amount on (i) the NASDAQ Composite Index, and (ii) the NASDAQ Biotechnology Index over the same period.
The graph set forth below compares the cumulative total stockholder return on an initial investment of $100 in our common stock from December 31, 2020 through December 31, 2025, with the comparative cumulative total return of such amount on (i) the NASDAQ Composite Index, and (ii) the NASDAQ Biotechnology Index over the same period.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is listed on the NASDAQ Global Select Market under the symbol “ESPR”. Stockholders As of January 31, 2025, there were 5 stockholders of record, which excludes stockholders whose shares were held in nominee or street name by brokers.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock is listed on the NASDAQ Global Select Market under the symbol “ESPR”. Stockholders As of February 28, 2026, there were 5 stockholders of record, which excludes stockholders whose shares were held in nominee or street name by brokers.
Following the closing of the Exchange Transaction, approximately $54.9 million in aggregate principal amount of 2025 Notes will remain outstanding with terms unchanged.
Following the closing of the Exchange Transaction, approximately $54.9 million in aggregate principal amount of 2025 Notes remained outstanding with terms unchanged.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

81 edited+21 added−25 removed54 unchanged
Biggest changeOur future funding requirements will depend on many factors, including, but not limited to: • our ability to successfully develop and commercialize NEXLETOL and NEXLIZET or other product candidates; • the service and payment of potential debt maturities; • our ability to establish any future collaboration or commercialization arrangements on favorable terms, if at all; • our ability to realize the intended benefits of our existing and future collaboration and partnerships, including receiving potential milestone payments from collaboration partners; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and • the implementation of operational and financial information technology.
Biggest changeOur future funding requirements will depend on many factors, including, but not limited to: • our ability to successfully develop and commercialize NEXLETOL and NEXLIZET or other product candidates; • the service and payment of potential debt maturities; • our ability to maintain existing collaborations and partnerships and our ability to establish any future collaboration or commercialization arrangements on favorable terms, if at all; 99 Table of Contents • our ability to realize the intended benefits of our existing and future collaboration and partnerships, including receiving potential milestone payments from collaboration partners; • the timing and results of clinical trials and regulatory actions relating to our product candidates or those of our competitors; • our ability to expand and advance our pipeline through business development activities, including collaborations, licensing arrangements or other strategic transactions, and our ability to execute and realize the anticipated and potential benefits of any such transactions we may pursue; • developments or disputes concerning patent applications, issued patents or other proprietary rights, including challenges to the validity, scope or enforceability of our issued patents, litigation or other proceedings arising from ANDA filings or similar regulatory submissions, and our ability to defend and enforce our intellectual property rights; • delays or disruptions in review, approval, inspection, or other actions by the FDA or other applicable U.S. or foreign government regulatory authorities that could impact the timing, initiation, conduct, or completion of our clinical trials or marketing applications; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • the implementation of operational and financial information technology; and • the impact of macroeconomic and geopolitical developments, including increases in inflationary rates, capital market disruptions, disruptions of U.S. governmental agencies, whether from U.S. federal government shutdowns or reduced resources, tariffs, trade protection measures, economic sanctions and related economic slowdowns or recessions, any of which could adversely affect our access to capital markets.
NILEMDO was approved by the EC, in March 2020 for use in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in adult patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies as an adjunct to diet in adult patients who are statin-intolerant, or for whom a statin is contraindicated.
NILEMDO was approved by the EC in March 2020 for use in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or alone or in combination with other lipid-lowering therapies as an adjunct to diet in adult patients who are statin-intolerant, or for whom a statin is contraindicated.
In May 2024, the EC approved an expanded indication for NILEMDO to reduce cardiovascular risk in patients with or at high risk for ASCVD. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
In May 2024, the EC approved an expanded indication for NILEMDO to reduce cardiovascular risk in patients with or at high risk for ASCVD. NUSTENDI contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and cholesterol absorption in the intestine.
Giving effect to the exercise of Underwriters' option, the January Offering closed on January 23, 2024, with proceeds to the Company of approximately $90.7 million, after deducting the underwriting discount and estimated offering expenses of $7.1 million.
Giving effect to the exercise of Underwriters' option, the January 2024 Offering closed on January 23, 2024, with proceeds to the Company of approximately $90.7 million, after deducting the underwriting discount and estimated offering expenses of $7.1 million.
Our lead products NEXLETOL® (bempedoic acid) tablets and NEXLIZET® (bempedoic acid and ezetimibe) tablets are oral, once-daily, non-statin medicines indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established CVD, or at high risk for a CVD event but without established CVD, and to reduce LDL-C in adults with primary hyperlipidemia.
Our lead products NEXLETOL® (bempedoic acid) tablets and NEXLIZET® (bempedoic acid and ezetimibe) tablets are oral, once-daily, non-statin medicines indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable or unwilling to take recommended statin therapy (including those not taking a statin) with established CVD, or at high risk for a CVD event but without established CVD, and to reduce LDL-C in adults with primary hyperlipidemia.
Given the early stage of our commercial operations we have provided constraint of our variable consideration due to its potential consumption trends. Actual amounts of consideration ultimately received may differ from our estimates. Each period, we review our estimates of rebates, co-pay assistance programs, distribution fees and other applicable provisions.
Given the stage of our commercial operations we have provided constraint of our variable consideration due to its potential consumption trends. Actual amounts of consideration ultimately received may differ from our estimates. Each period, we review our estimates of rebates, co-pay assistance programs, distribution fees and other applicable provisions.
We expect our selling, general and administrative expenses will be consistent in 2025 as it was in 2024 after the additional global regulatory approvals for new product indications in 2024 and the associated expanded commercialization initiatives for NEXLETOL and NEXLIZET and increases in our associated headcount to expand our sales team.
We expect our selling, general and administrative expenses will be consistent in 2026 as it was in 2025 after the additional global regulatory approvals for new product indications in 2024 and the associated expanded commercialization initiatives for NEXLETOL and NEXLIZET and increases in our associated headcount to expand our sales team.
Refer to Note 1 and 3 in our audited financial statements appearing elsewhere in this Annual Report on Form 10-K for further information. Cost of Goods Sold Cost of goods sold is related to our net product sales of NEXLETOL and NEXLIZET and our supply agreements with collaboration partners.
Refer to Note 3 in our audited financial statements appearing elsewhere in this Annual Report on Form 10-K for further information. Cost of Goods Sold Cost of goods sold is related to our net product sales of NEXLETOL and NEXLIZET and our supply agreements with collaboration partners.
The interest rate on the liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted royalty sales. This estimate is complex and highly judgmental due to the estimation uncertainty in determining the effective interest rate.
The interest rate on the liability may vary during the term of the agreement depending on a number of factors, including the level and timing of forecasted royalty sales. This estimate is complex and highly judgmental due to the estimation uncertainty in determining the effective interest rate.
Product Overview NEXLETOL is a first-in-class ATP Citrate Lyase, or ACLY, inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating the LDL receptors.
Product Overview NEXLETOL is a first-in-class ATP Citrate Lyase, or ACLY, inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating LDL receptors.
NEXLETOL and NEXLIZET were commercially available in the U.S. on March 30, 2020 and June 4, 2020, respectively. Collaboration revenue Collaboration revenue is related to our collaboration agreements with Daiichi Sankyo and Otsuka.
NEXLETOL and NEXLIZET were commercially available in the U.S. on March 30, 2020 and June 4, 2020, respectively. Collaboration revenue Collaboration revenue is primarily related to our collaboration agreements with Daiichi Sankyo and Otsuka.
Net cash used in operating activities for the year ended December 31, 2024 consisted primarily of net product sales of NEXLETOL and NEXLIZET, the Settlement Agreement with DSE and other cash received from our collaboration agreements fully offset by cash used to fund the commercialization activities of NEXLETOL and NEXLIZET and the research and development costs related to bempedoic acid and the bempedoic acid / ezetimibe combination tablet, adjusted for non-cash expenses such as the loss extinguishment of debt associated with our RIPA and convertible note Exchange Transaction, royalty revenue paid or to be paid to OMERS, stock-based compensation expense, interest expense related to our RIPA with Oberland and royalty sale agreement, amortization of issuance costs on our convertible notes, depreciation and amortization and changes in working capital.
Net cash used in operating activities for the year ended December 31, 2024 consisted primarily of net product sales of NEXLETOL and NEXLIZET, the Settlement Agreement with DSE and other cash received from our collaboration 97 Table of Contents agreements fully offset by cash used to fund the commercialization activities of NEXLETOL and NEXLIZET and the research and development costs related to bempedoic acid and the bempedoic acid / ezetimibe combination tablet, adjusted for non-cash expenses such as the loss extinguishment of debt associated with our RIPA and convertible note Exchange Transaction, royalty revenue paid or to be paid to OMERS, stock-based compensation expense, interest expense related to our RIPA with Oberland and royalty sale agreement, amortization of issuance costs on our convertible notes, depreciation and amortization and changes in working capital.
The completed Phase 3 Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial in patients unwilling or unable to take statins and who had, or were at high risk for, CVD demonstrated on average a 20.0% placebo corrected LDL-C lowering, and a resulting 13% lower risk of major cardiovascular events versus placebo.
The completed Phase 3 Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial in patients unwilling or unable to take statins and who had, or were at high risk for, CVD demonstrated on average a 20% placebo corrected LDL-C reduction, and a resulting 13% lower risk of major cardiovascular events versus placebo.
Collaboration revenue in the years ended December 31, 2023 and 2022 was primarily related to sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
Collaboration revenue in the years ended December 31, 2023 was primarily related to sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
A significant increase or decrease in royalties will materially impact the royalty sale liability, interest expense and the time period for repayment. A 3% increase in quarterly forecasted revenues would increase interest expense by approximately $0.2 million, increase the royalty sale liability by $0.2 million, and would have no change on the estimated time period for repayment.
A significant increase or decrease in royalties will materially impact the royalty sale liability, interest expense and the time period for repayment. A 3% increase in quarterly forecasted revenues would increase interest expense by approximately $0.1 million, increase the royalty sale liability by $0.1 million, and would have no change on the estimated time period for repayment.
Research and Development Expenses Our research and development expenses consist primarily of costs incurred in connection with the development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and any other product candidate we may choose to pursue, which include: • expenses incurred under agreements with consultants, contract research organizations, or CROs, and investigative sites that conduct our preclinical and clinical studies; • the cost of acquiring, developing and manufacturing clinical study materials and commercial product manufacturing supply prior to product approval, including the procurement of ezetimibe in our continued development of our bempedoic acid / ezetimibe combination tablet; • employee-related expenses, including salaries, benefits, stock-based compensation and travel expenses; • allocated expenses for rent and maintenance of facilities, insurance and other supplies; and • costs related to compliance with regulatory requirements.
Research and Development Expenses Our research and development expenses consist primarily of costs incurred in connection with the development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and any other product candidate we may choose to pursue, which include: • expenses incurred under agreements with consultants, contract research organizations, or CROs, and investigative sites that conduct our preclinical and clinical studies; • the cost of acquiring, developing and manufacturing clinical study materials and commercial product manufacturing supply prior to product approval, including the procurement of ezetimibe in our continued development of our bempedoic acid / ezetimibe combination tablet; • employee-related expenses, including salaries, benefits, stock-based compensation and travel expenses; • allocated expenses for rent and maintenance of facilities, insurance and other supplies; and • costs related to compliance with regulatory requirements. 92 Table of Contents We expense research and development costs as incurred.
Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
Debt and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
Interest expense for the year ended December 31, 2024 was related to our revenue interest liability, or RIPA, which we repurchased on June 27, 2024, of $21.6 million, our royalty sale liability, entered into on June 27, 2024, of $24.7 million, our convertible notes, of $12.2 million, and our Credit Agreement, entered into on December 13, 2024, of $0.8 million.
Interest expense for the year ended December 31, 2024 was related to our revenue interest liability, or RIPA, which we repurchased on June 27, 2024, of $21.6 million, our royalty sale liability, of $24.7 million, our convertible notes, of $12.2 million, and our Credit Agreement, of $0.8 million.
On January 18, 2024, we entered into the Underwriting Agreement with Jefferies, as representative of the Underwriters, related to the January 2024 Offering of 56,700,000 shares of our common stock, at a purchase price to the public of $1.50 per share.
On January 18, 2024, we entered into an underwriting agreement with Jefferies, as representative of the Underwriters, related to an underwritten public offering, or the January 2024 Offering, of 56,700,000 shares of our common stock, at a purchase price to the public of $1.50 per share.
Loss on extinguishment of debt and exchange transaction Loss on extinguishment of debt and exchange transaction for year ended December 31, 2024, was $54.9 million, with no such loss recognized for the year ended December 31, 2023.
Loss on extinguishment of debt and exchange transaction Loss on extinguishment of debt and exchange transaction for year ended December 31, 2024, was $54.9 million, with no such loss recognized for the year ended December 31, 2025.
Refer to Note 13 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K for further information. Plan of Operations and Funding Requirements We expect to continue to incur expenses and operating losses for the near term future in connection with our continued commercialization activities associated with NEXLETOL and NEXLIZET in the U.S.
Refer to Note 13 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K for further information. Plan of Operations and Funding Requirements We expect to continue to incur operating losses for the immediate future in connection with our continued commercialization activities associated with NEXLETOL and NEXLIZET in the U.S.
On February 21, 2023, we terminated the Open Market Sales Agreement with Jefferies LLC and entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent, to provide for the issuance and sale by us of up to $70 million of shares of our common stock from time to time in “at-the-market” offerings, or the 2023 ATM Program, pursuant to our existing Form S-3 and the prospectus supplement filed on February 21, 2023.
On February 21, 2023, we entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent, to provide for the issuance and sale by us of up to $70 million of shares of our common stock from time to time in “at-the-market” offerings, or the 2023 ATM Program, pursuant to our existing Form S-3 and the prospectus supplement filed on February 21, 2023.
Collaboration revenue in the year ended December 31, 2024 was primarily related to the settlement agreement, or Settlement Agreement, with Daiichi Sankyo Europe GmbH, or DSE, a milestone from Otsuka upon first Japanese New Drug Application, or JNDA, submission in the Otsuka Territory, sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
Collaboration revenue in the year ended December 31, 2024 was primarily related to the Settlement Agreement with DSE, a milestone from Otsuka upon first Japanese New Drug Application, or JNDA, submission in the Otsuka Territory, sales of bulk tablets under supply agreements and royalty revenue received from collaboration partners.
Our net loss for the year ended December 31, 2024 was primarily due to the loss on extinguishment on the Oberland RIPA and convertible notes Exchange Transaction, interest expense and costs incurred in connection with research and development programs and selling, general and administrative costs associated with our operations, offset partially by the Settlement Agreement with DSE and other revenue from our net product sales and collaboration agreements.
Our net loss for the year ended December 31, 2024 was primarily due to the loss on extinguishment on the Oberland RIPA and convertible notes Exchange Transaction, interest expense and costs incurred in connection with research and development programs and selling, general and administrative costs associated with our operations, offset partially by the settlement agreement, or Settlement Agreement, with Daiichi Sankyo Europe GmbH, or DSE. and other revenue from our net product sales and collaboration agreements.
Refer to Note 12 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K. On December 13, 2024, we entered into a Credit Agreement for a $150.0 million Loan, which was borrowed in full at closing.
Refer to Note 12 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K. 98 Table of Contents On December 13, 2024, we entered into a Credit Agreement for a $150.0 million Loan, which was borrowed in full at closing.
We expect to incur significant expenses and operating losses for the near term future in connection with our ongoing activities, including, among others: • commercializing NEXLETOL and NEXLIZET in the U.S; and • pursuing other research and development activities. Accordingly, we may need additional financing to support our continuing operations and further the development and commercialization of our products.
We expect to incur operating losses for the immediate future in connection with our ongoing activities, including, among others: • commercializing NEXLETOL and NEXLIZET in the U.S; and • pursuing other research and development activities. Accordingly, we may need additional financing to support our continuing operations and further the development and commercialization of our products.
If actual results vary from estimates, we adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. A 3% change to our year ended December 31, 2024 net product sales would have an impact of approximately $3.5 million.
If actual results vary from estimates, we adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. A 3% change to our year ended December 31, 2025 net product sales would have an impact of approximately $4.8 million.
Because of the numerous risks and uncertainties associated with the development and ongoing commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, and the extent to which we entered and may enter into collaborations with pharmaceutical partners regarding the development and commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development and commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet.
Because of the numerous risks and uncertainties associated with the development and ongoing commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any of our product candidates, and the extent to which we entered and may enter into collaborations with pharmaceutical partners regarding the development and commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development and commercialization of bempedoic acid and the bempedoic acid / ezetimibe combination tablet or any of our product candidates.
We have incurred losses in each year since our inception. We have never been profitable and our net losses were $51.7 million, $209.2 million and 233.7 million for the years ended December 31, 2024, 2023, and 2022 respectively.
We have incurred losses in each year since our inception. We have never been profitable and our net losses were $22.7 million, $51.7 million and 209.2 million for the years ended December 31, 2025, 2024, and 2023, respectively.
Substantially all of our net losses for the years ended December 31, 2023 and 2022 resulted from costs incurred in connection with research and development programs and selling, general and administrative costs associated 83 Table of Contents with our operations.
Substantially all of our net losses for the years ended December 31, 2023 resulted from costs incurred in connection with research and development programs and selling, general and administrative costs associated with our operations.
For a comparison of our results of operations for the fiscal years ended December 31, 2023 and December 31, 2022, see "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on February 27, 2024.
For a comparison of our results of operations for the fiscal years ended December 31, 2024 and December 31, 2023, see "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 7, 2025.
The duration, costs and timing associated with the development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet will depend on a variety of factors, including uncertainties associated with the results of our clinical studies and our ability to obtain regulatory approval outside the U.S. and Europe.
The duration, costs and timing associated with the development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet will depend on a variety of factors, including uncertainties associated with the results of our clinical studies and our ability to obtain regulatory approval outside the U.S., Europe, Japan, and other currently approved countries.
We do not currently have, nor did we have during the periods presented, any off-balance sheet arrangements as defined by Securities and Exchange Commission rules, or the SEC, rules.
We do not currently have, nor did we have during the periods presented, any off-balance sheet arrangements as defined by Securities and Exchange Commission rules, or the SEC, rules. 100 Table of Contents
If we are unable to raise additional funds through equity or permitted debt 92 Table of Contents financings or through collaborations, strategic alliances or licensing arrangements or permitted royalty-based financing arrangements when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market bempedoic acid and the bempedoic acid / ezetimibe combination tablet that we would otherwise prefer to develop and market ourselves.
If we are unable to raise additional funds through equity or permitted debt financings or through collaborations, strategic alliances or licensing arrangements or permitted royalty-based financing arrangements when needed and on favorable terms, if at all, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market bempedoic acid and the bempedoic acid / ezetimibe combination tablet that we would otherwise prefer to develop and market ourselves.
Investing Activities Net cash used in investing activities of $0.3 million for the year ended December 31, 2024 consisted of purchases of property and equipment.
Investing Activities There was no cash used in investing activities for the year ended December 31, 2025. Net cash used in investing activities of $0.3 million for the year ended December 31, 2024 consisted of purchases of property and equipment.
NEXLETOL was commercially available in the U.S. on March 30, 2020 and NEXLIZET was commercially available in the U.S. on June 4, 2020.
In February 2020, the FDA approved NEXLETOL and NEXLIZET. NEXLETOL was commercially available in the U.S. on March 30, 2020 and NEXLIZET was commercially available in the U.S. on June 4, 2020.
The increase is primarily due to prescription growth volumes of NEXLETOL and NEXLIZET. Collaboration revenue Collaboration revenue recognized from our collaboration agreements for the year ended December 31, 2024 was $216.6 million compared to $38.0 million for the year ended December 31, 2023, an increase of $178.6 million.
The increase is primarily due to prescription growth volumes of NEXLETOL and NEXLIZET. Collaboration revenue Collaboration revenue recognized from our collaboration agreements for the year ended December 31, 2025 was $243.6 million compared to $216.6 million for the year ended December 31, 2024, an increase of $27.0 million.
The following table summarizes the primary sources and uses of cash for the periods presented below: Year Ended December 31, 2024 2023 (in thousands) Net cash used in operating activities $ (23,654) $ (135,487) Net cash (used in) provided by investing activities (317) 42,500 Net cash provided by financing activities 86,484 50,460 Net increase (decrease) in cash and cash equivalents $ 62,513 $ (42,527) Operating Activities We have incurred and expect to continue to incur, significant costs related to the commercialization of NEXLETOL and NEXLIZET and related to ongoing research and development, regulatory and other clinical study costs associated with the development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and our early stage pipeline assets.
The following table summarizes the primary sources and uses of cash for the periods presented below: Year Ended December 31, 2025 2024 (in thousands) Net cash used in operating activities $ (13,093) $ (23,654) Net cash used in investing activities — (317) Net cash provided by financing activities 36,184 86,484 Net increase in cash and cash equivalents $ 23,091 $ 62,513 Operating Activities We have incurred and expect to continue to incur, significant costs related to the commercialization of NEXLETOL and NEXLIZET and related to ongoing research and development, regulatory and other clinical study costs associated with the development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and our early stage pipeline assets.
We expense research and development costs as incurred. To date, substantially all of our research and development work has been related to bempedoic acid and the bempedoic acid / ezetimibe combination tablet and our early stage pipeline assets.
To date, substantially all of our research and development work has been related to bempedoic acid and the bempedoic acid / ezetimibe combination tablet and our early stage pipeline assets.
Cost of goods sold Cost of goods sold for the year ended December 31, 2024, was $68.6 million compared to $43.3 million for the year ended December 31, 2023, an increase of $25.3 million. The increase is primarily related to increased product sales to our collaboration partners under our supply agreements and increased net product sales of NEXLETOL and NEXLIZET.
Cost of goods sold Cost of goods sold for the year ended December 31, 2025, was $129.2 million compared to $68.6 million for the year ended December 31, 2024, an increase of $60.6 million. The increase is primarily related to increased product sales to our collaboration partners under our supply agreements and increased net product sales of NEXLETOL and NEXLIZET.
As of December 31, 2024, no pre-funded warrants were outstanding. During the year ended December 31, 2024, we received net proceeds of approximately $14.8 million from the exercise of warrants. During the year ended December 31, 2023, we received net proceeds of approximately $8.4 million from the exercise of warrants and pre-funded warrants.
As of December 31, 2024, no pre-funded warrants were outstanding. During the year ended December 31, 2025, we received net proceeds of approximately $10.3 million from the exercise of warrants. During the year ended December 31, 2024, we received net proceeds of approximately $14.8 million from the exercise of warrants.
Through December 31, 2024, the royalties recognized and settled to the Purchaser was $26.1 million The Company expects future royalties to OMERS may range from $47.6 million in the next year to a maximum total payment of approximately $444.2 million beyond one year.
Through December 31, 2025, the royalties recognized and settled to the Purchaser was $81.1 million The Company expects future royalties to OMERS may range from $87.6 million in the next year to a maximum total payment of approximately $349.2 million beyond one year.
Our actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are described in more detail in Note 2 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K.
Our actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are described in more detail in Note 2 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K. We believe the following accounting policies to be most critical to understanding our results and financial operations.
Future payments under the 4.00% 2025 Notes include annual interest of $2.2 million and a principal payment of $54.9 million due in November 2025 . Refer to Note 12 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K.
Payments under the 4.00% 2025 Notes after the Exchange Transaction included annual interest of $2.2 million and a principal payment of $54.9 million . In November 2025, we repaid the 2025 Notes in full and have no future payments. Refer to Note 12 to our audited financial statements appearing elsewhere in this Annual Report on Form 10-K.
Net cash used in operating activities totaled $23.7 million for the year ended December 31, 2024 and $135.5 million for the year ended December 31, 2023.
Net cash used in operating activities totaled $13.1 million for the year ended December 31, 2025 and $23.7 million for the year ended December 31, 2024.
During the years ended December 31, 2023 and December 31, 2022, we incurred $46.2 million and $83.5 million, respectively, in direct expenses related to our CLEAR Outcomes CVOT and other ongoing clinical studies. 84 Table of Contents Financial Operations Overview Product sales, net Product sales, net is related to our sales of NEXLETOL and NEXLIZET.
During the year ended December 31, 2024, we incurred $6.6 million related to ongoing clinical trials. During the year ended December 31, 2023, we incurred $46.2 million in direct expenses related to our CLEAR Outcomes CVOT and other ongoing clinical studies. Financial Operations Overview Product sales, net Product sales, net is related to our sales of NEXLETOL and NEXLIZET.
On June 27, 2024, we entered into a Royalty Purchase Agreement (the “Purchase Agreement”) with OMERS. Pursuant to the Purchase Agreement, we sold a portion of the royalties payable on net sales of Bempedoic Acid from our collaboration partner DSE. Pursuant to the Purchase Agreement, we received $304.7 million, less issuance costs.
Pursuant to the Purchase Agreement, we sold a portion of the royalties payable on net sales of Bempedoic Acid from our collaboration partner DSE. Pursuant to the Purchase Agreement, we received $304.7 million, less issuance costs.
Net cash used in operating activities for the year ended December 31, 2023 consisted of net product sales of NEXLETOL and NEXLIZET fully offset by cash used to fund the commercialization activities of NEXLETOL and NEXLIZET and the research and development costs related to bempedoic acid and the bempedoic acid / ezetimibe combination tablet, adjusted for non-cash expenses such as stock-based compensation expense, interest expense related to our RIPA with Oberland and the amortization of issuance costs on our convertible notes, depreciation and amortization and changes in working capital.
Net cash used in operating activities for the year ended December 31, 2025 consisted of net product sales of NEXLETOL and NEXLIZET, the milestone payment from Otsuka, and other cash received from our collaboration agreements, fully offset by cash used to fund the commercialization activities of NEXLETOL and NEXLIZET and the research and development costs related to bempedoic acid and the bempedoic acid / ezetimibe combination tablet, adjusted for non-cash expenses such as royalty revenue paid or to be paid to OMERS, stock-based compensation expense, interest expense, the amortization of issuance costs on our convertible notes, depreciation and amortization and changes in working capital.
Interest Expense Interest expense for the year ended December 31, 2024 was related to our Royalty Purchase Agreement with OMERS, entered into on June 27, 2024, our RIPA with Oberland, our Loan, entered into on December, 13, 2024, and our convertible notes.
Interest Expense Interest expense for the year ended December 31, 2025 was related to our Royalty Purchase Agreement with OCM IP Healthcare Portfolio LP, or OMERS, entered into on June 27, 2024, our term loan, or Loan, entered into on December, 13, 2024, and our convertible notes.
Interest expense for the years ended December 31, 2023 and December 31, 2022 was related to our RIPA and our convertible notes. Loss on extinguishment of debt and exchange transaction Loss on extinguishment of debt and exchange transaction is related to the loss recognized from the termination of our RIPA with Oberland and the Exchange Transaction of our Convertible Notes.
Loss on extinguishment of debt and exchange transaction Loss on extinguishment of debt and exchange transaction is related to the loss recognized from the termination of our RIPA with Oberland and an exchange transaction of our convertible notes for the year ended December 31, 2024.
Other Income Other income, net, for the years ended December 31, 2024, December 31, 2023 and December 31, 2022 primarily relates to interest income and the accretion or amortization of premiums and discounts earned on our cash, cash equivalents and investment securities and also includes other income related to the sale of leased vehicles.
Other Income Other income, net, for the years ended December 31, 2025, December 31, 2024 and December 31, 2023 primarily relates to interest income and the accretion or amortization of premiums and discounts earned on our cash, cash equivalents and investment securities and also includes other income (expense) related to the sale of leased vehicles. 93 Table of Contents Provision for income taxes Provision for income taxes for the year ended December 31, 2025, consisted of state current tax expense.
The increase is primarily due to revenue recognized from our Settlement Agreement with DSE in the first half of 2024, a one-time milestone from Otsuka upon first JNDA submission in the Otsuka Territory, increased product sales to our collaboration partners from our supply agreements and royalty sales growth within our partner territories.
The increase is primarily due to revenue recognized from the one-time milestone payment from Otsuka related to NEXLETOL approval and NHI pricing, increased product sales to our collaboration partners from our supply agreements and royalty sales growth within our partner territories, offset partially by revenue recognized from our Settlement Agreement with DSE in the first half of 2024.
We believe the following accounting policies to be most critical to understanding our results and financial operations. 86 Table of Contents Product Sales, Net We sell NEXLETOL and NEXLIZET to wholesalers in the U.S. and, in accordance with ASC 606, recognize revenue at the point in time when the customer is deemed to have obtained control of the product, which generally occurs upon receipt by the customer.
Product Sales, Net We sell NEXLETOL and NEXLIZET to wholesalers in the U.S. and, in accordance with ASC 606, recognize revenue at the point in time when the customer is deemed to have obtained control of the product, which generally occurs upon receipt by the customer.
Such program will continue to be subject to the volatility of the price of our common stock and general market conditions. 91 Table of Contents On March 22, 2023, we issued and sold, in the Registered Direct Offering, 12,205,000 shares of our common stock, pre-funded warrants to purchase up to an aggregate of 20,965,747 shares of our common stock, and warrants to purchase up to 33,170,747 shares of our common stock.
On March 22, 2023, we issued and sold, in the Registered Direct Offering, 12,205,000 shares of our common stock, pre-funded warrants to purchase up to an aggregate of 20,965,747 shares of our common stock, and warrants to purchase up to 33,170,747 shares of our common stock.
Other income, net Other income, net for the year ended December 31, 2024, was $8.0 million compared to $5.3 million for the year ended December 31, 2023, an increase of $2.7 million. This increase was primarily due to higher interest income due to higher cash and cash equivalents.
Other income, net Other income, net for the year ended December 31, 2025, was $3.5 million compared to $8.0 million for the year ended December 31, 2024, a decrease of $4.5 million. This decrease was primarily due to lower interest income due to lower cash and cash equivalents.
In May 2024, the EC approved an expanded indication for NUSTENDI to reduce cardiovascular risk in patients with or at high risk for ASCVD. During the years ended December 31, 2024, we incurred $6.6 million related to ongoing clinical studies.
In May 91 Table of Contents 2024, the EC approved an expanded indication for NUSTENDI to reduce cardiovascular risk in patients with or at high risk for ASCVD. During the year ended December 31, 2025, we incurred $15.3 million related to ongoing clinical studies, including our pediatric program.
We will continue to incur research and development expenses as they relate to other development programs or additional indications we choose to pursue such as the development of our next generation ACLY inhibitors.
We will continue to incur research and development expenses as they relate to other development programs or additional indications we choose to pursue such as the development of our next generation ACLY inhibitors. We expect research and development expenses to remain consistent in 2026 as we continue our phase III pediatric trial and continue progressing our preclinical pipeline.
We were incorporated in Delaware in January 2008, and commenced our operations in April 2008. Since our inception, we have focused substantially all of our efforts and financial resources on developing and commercializing bempedoic acid and the bempedoic acid / ezetimibe tablet. In February 2020, the FDA approved NEXLETOL and NEXLIZET.
The transaction is expected to close in the second quarter of 2026. We were incorporated in Delaware in January 2008, and commenced our operations in April 2008. Since our inception, we have focused substantially all of our efforts and financial resources on developing and commercializing bempedoic acid and the bempedoic acid / ezetimibe tablet.
We estimate that current cash resources, proceeds to be received in the future for product sales and proceeds under the collaboration agreements with Daiichi Sankyo and Otsuka are sufficient to fund operations for the foreseeable future.
We estimate that current cash resources, proceeds to be received in the future for product sales and proceeds under the collaboration agreements with Daiichi Sankyo and Otsuka are sufficient to fund operations for the foreseeable future. To finance the acquisition under the Merger Agreement with Corstasis, we plan to leverage our existing credit facilities and monetize our Japanese royalties.
During 2023, we issued 3,312,908 shares of common stock resulting in net proceeds of approximately $4.4 million after deducting $0.4 million of underwriting discounts and commissions and other expenses, pursuant to the 2023 ATM Program.
During the year ended December 31, 2025, we issued 7,661,505 shares of common stock resulting in net proceeds of approximately $15.4 million after deducting approximately $0.4 million of commissions and other expenses, pursuant to the 2023 ATM Program.
During the year ended December 31, 2024, we issued 378,902 shares of common stock resulting in net proceeds of approximately $0.5 million after deducting approximately $0.2 million of commissions and expense reimbursement payable to sales agent and other expenses, pursuant to the 2023 ATM Program.
During the year ended December 31, 2025, we issued 7,661,505 shares of common stock resulting in net proceeds of approximately $15.4 million after deducting approximately $0.4 million of commissions and other expenses, pursuant to the 2023 ATM Program.
Research and development expenses Research and development expenses for the year ended December 31, 2024, were $46.2 million compared to $86.1 million for the year ended December 31, 2023, a decrease of $39.9 million.
Research and development expenses Research and development expenses for the year ended December 31, 2025, were $47.9 million compared to $46.2 million for the year ended December 31, 2024, an increase of approximately $1.7 million.
As part of our December 2024 Credit Agreement and Exchange Transaction for our 2025 and 2030 Notes, as described in more detail below, the Company added approximately $26.5 million of net cash and cash equivalents to the balance sheets after payments of original issue discount, issuance costs and accrued interest on the partial extinguishment of the 2025 Notes. 89 Table of Contents We anticipate that we will incur operating losses for the near term future as we continue to incur substantial expenses related to the ongoing commercialization of NEXLETOL and NEXLIZET and expenses associated with our research and development activities.
As part of our December 2024 Credit Agreement and Exchange Transaction for our 2025 and 2030 Notes, as described in more detail below, the Company added approximately $26.5 million of net cash and cash equivalents to the balance sheets after payments of original issue discount, issuance costs and accrued interest on the partial extinguishment of the 2025 Notes.
Our products were approved by the FDA, the European Commission, or EC, and Swiss Agency for Therapeutic Products, or Swissmedic in 2020. The FDA approved expanded indications for NEXLETOL and NEXLIZET tablets in March 2024. The EC approved expanded indications for NILEMDO® (bempedoic acid) tablets and NUSTENDI (bempedoic acid and ezetimibe) tablets in May 2024.
Our products were approved by the FDA, the European Commission, or EC (which, with respect to the UK, has been converted to a UK marketing authorization), and Swiss Agency for Therapeutic Products, or Swissmedic in 2020. The FDA approved expanded indications for NEXLETOL and NEXLIZET tablets in March 2024.
Future payments under the Loan are expected to be annual interest of $14.6 million ($15.4 million in 2025 with the additional portion related to the fourth quarter of 2024), $18.8 million in principal in the year ended December 31, 2028, and the remaining approximately $131.2 million in principal in the year ended December 31, 2029.
Future payments under the Loan are expected to be annual interest of $15.7 million, $19.9 million in principal in the year ended December 31, 2028, and the remaining approximately $139.2 million in principal in the year ended December 31, 2029.
The increase in selling, general and administrative expenses was primarily attributable to increased commercial headcount, bonuses, and promotional costs associated with the launch of the expanded labels for NEXLETOL and NEXLIZET. 88 Table of Contents Interest expense Interest expense for the year ended December 31, 2024, was $59.3 million, compared to $59.0 million for the year ended December 31, 2023, an increase of $0.3 million.
The increase in selling, general and administrative expenses was primarily attributable to increased legal costs associated with the ANDA litigation. Interest expense Interest expense for the year ended December 31, 2025, was $84.6 million, compared to $59.3 million for the year ended December 31, 2024, an increase of approximately $25.3 million.
We invest our cash equivalents and investments in highly liquid, interest-bearing investment-grade securities and government securities to preserve principal.
As of December 31, 2025, our primary sources of liquidity were our cash and cash equivalents which totaled $167.9 million. We invest our cash equivalents and investments in highly liquid, interest-bearing investment-grade securities and government securities to preserve principal.
The decrease in cash used in operating activities for the year ended December 31, 2024 compared to the year ended December 31, 2023 was primarily related to a decrease in net loss resulting from increases in net product sales and collaboration revenue, primarily related to our Settlement Agreement with DSE and lower research and development costs following the public presentation of our CLEAR Outcomes CVOT in 2023, partially offset by increases in selling, general, and administrative expenses due to increased commercial headcount and promotional expenses with the launch of the expanded labels in NEXLETOL and NEXLIZET, increases in inventory, and increases in cost of goods sold related to additional sales, adjusted for normal working capital and timing of cash outlays.
The decrease in cash used in operating activities for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily related to a decrease in net loss resulting from increases in net product sales and collaboration revenue, primarily related to our milestone payments from Otsuka, partially offset by increases in inventory and prepaid inventory and increases in cost of goods sold related to additional sales, adjusted for normal working capital and timing of cash outlays.
At the Company’s option, interest on the Loan may be paid-in-kind for the first four full fiscal quarters ending after the closing date.
At the Company’s option, interest on the Loan may be paid-in-kind for the first four full fiscal quarters ending after the closing date. As the Company elected to have interest on the loan paid-in-kind for the quarter ended June 30, 2025 and for the quarter ended September 30, 2025, $9.1 was added to the principal balance of the Loan.
We anticipate that our current cash and cash equivalents, expected future net product sales of NEXLETOL and NEXLIZET, and expected future revenue under our collaboration agreements is sufficient to fund continuing operations for the near term future. As of December 31, 2024, our primary sources of liquidity were our cash and cash equivalents which totaled $144.8 million.
We anticipate that our current cash and cash equivalents, expected future net product sales of NEXLETOL and NEXLIZET, and expected future revenue under our collaboration agreements is sufficient to fund continuing operations for the near term future. To finance the acquisition under the Merger Agreement with Corstasis, we plan to leverage our existing credit facilities and monetize our Japanese royalties.
Net cash provided by financing activities of $50.5 million for the year ended December 31, 2023, related primarily to proceeds from our registered direct offering, or Registered Direct Offering, exercise of warrants, and net proceeds from our 2023 ATM Program, partially offset by payments on our RIPA with Oberland.
Financing Activities Net cash provided by financing activities of $36.2 million for the year ended December 31, 2025, related primarily to cash received from our 2023 ATM program, October 2025 Offering, and warrant exercises, offset partially by payment of the 2025 convertible notes and issuance costs on our December 2024 Credit Agreement and Exchange Transaction.
Selling, general and administrative expenses Selling, general and administrative expenses for the year ended December 31, 2024, were $163.1 million compared to $142.5 million for the year ended December 31, 2023, an increase of $20.6 million.
The increase in research and development expenses was primarily attributable to increase in costs for ongoing pediatric clinical studies. 95 Table of Contents Selling, general and administrative expenses Selling, general and administrative expenses for the year ended December 31, 2025, were $165.8 million compared to $163.1 million for the year ended December 31, 2024, an increase of $2.7 million.
Recent Accounting Pronouncements Adopted For information on new accounting standards and the impact, on our financial position or results of operations, see Note 2 to our audited financial statements found elsewhere in this Annual Report on Form 10-K. 87 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: Year Ended December 31, 2024 2023 Change (in thousands) Revenues: Product sales, net $ 115,725 $ 78,335 $ 37,390 Collaboration revenue 216,589 37,999 178,590 Operating expenses: Cost of goods sold 68,601 43,267 25,334 Research and development 46,238 86,107 (39,869) Selling, general and administrative 163,073 142,523 20,550 Income (loss) from operations 54,402 (155,563) 209,965 Interest expense (59,251) (58,976) (275) Loss on extinguishment of debt and exchange transaction (54,918) — (54,918) Other income, net 8,022 5,291 2,731 Net loss $ (51,745) $ (209,248) $ 157,503 Product sales, net Product sales, net for the year ended December 31, 2024 was $115.7 million compared to $78.3 million for the year ended December 31, 2023, an increase of $37.4 million.
Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024: Year Ended December 31, 2025 2024 Change (in thousands) Revenues: Product sales, net $ 159,569 $ 115,725 $ 43,844 Collaboration revenue 243,566 216,589 26,977 Operating expenses: Cost of goods sold 129,224 68,601 60,623 Research and development 47,852 46,238 1,614 Selling, general and administrative 165,786 163,073 2,713 Income from operations 60,273 54,402 5,871 Interest expense (84,604) (59,251) (25,353) Loss on extinguishment of debt and exchange transaction — (54,918) 54,918 Other income, net 3,490 8,022 (4,532) Loss before income taxes $ (20,841) $ (51,745) $ 30,904 Provision for taxes on income 1,841 — 1,841 Net loss $ (22,682) $ (51,745) $ 29,063 Product sales, net Product sales, net for the year ended December 31, 2025 was $159.6 million compared to $115.7 million for the year ended December 31, 2024, an increase of approximately $43.9 million.
Interest expense for the year ended December 31, 2023, was related to our revenue interest liability of $46.7 million and convertible notes of $12.3 million.
Interest expense for the year ended December 31, 2024 was related to our Royalty Purchase Agreement with OMERS, our revenue interest purchase agreement, or RIPA, with Eiger III SA LLC, or Oberland, our Loan, and our convertible notes. Interest expense for the year ended December 31, 2023 was related to our RIPA and our convertible notes.
Phase 3 data demonstrated NEXLIZET lowered LDL-C by a mean of 38% compared to placebo when added on to maximally tolerated statins. NEXLIZET was approved by the FDA in February 2020 and received an expanded cardiovascular risk reduction indication from the FDA in March 2024.
NEXLIZET contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and cholesterol absorption in the intestine. Phase 3 data demonstrated NEXLIZET lowered LDL-C by a mean of 38% compared to placebo when added on to maximally tolerated statins.
On January 2, 2024, we entered into the Settlement Agreement with DSE to amicably resolve and dismiss the commercial dispute then pending in the Southern District of New York.
During the year ended December 31, 2024, we issued 378,902 shares of common stock resulting in net proceeds of approximately $0.5 million after deducting approximately $0.2 million of commissions and expense reimbursement payable to sales agent and other expenses, pursuant to the 2023 ATM Program. 96 Table of Contents On January 2, 2024, we entered into the Settlement Agreement with DSE to amicably resolve and dismiss the commercial dispute then pending in the Southern District of New York.
Net cash provided by investing activities of $42.5 million for the year ended December 31, 2023 consisted primarily of net proceeds from the sales of highly liquid, interest bearing investment grade and government securities. 90 Table of Contents Financing Activities Net cash provided by financing activities of $86.5 million for the year ended December 31, 2024, related primarily to proceeds from our January 2024 Offering, royalty sale agreement, the Loan and issuance of convertible notes and warrant exercises, offset partially by the cash outlays resulting in the extinguishment of our RIPA and Exchange Transaction of convertible notes.
Net cash provided by financing activities of $86.5 million for the year ended December 31, 2024, related primarily to proceeds from our January 2024 Offering, royalty sale agreement, the Loan and issuance of convertible notes and warrant exercises, offset partially by the cash outlays resulting in the extinguishment of our RIPA and Exchange Transaction of convertible notes On October 7, 2025, we entered into the 2025 Underwriting Agreement with Piper Sandler & Co. and Cantor Fitzgerald & Co., as representatives of the 2025 Underwriters, pursuant to which we issued and sold an aggregate of 31,065,000 shares of Common Stock, which includes the partial exercise of the underwriters’ option to purchase 1,065,000 additional shares, at the public offering price of $2.50 per share.
Otsuka filed a New Drug Application, or NDA, in Japan in November 2024, with expected approval and National Health Insurance, or NHI, pricing in the second half of 2025. We filed supplemental NDAs for product approvals in Canada in November 2024 and our collaboration partners plan to file in Australia and Israel in the first half of 2025.
We filed supplemental NDAs for product approvals in Canada in November 2024, with NEXLETOL approval in the fourth quarter of 2025 and NEXLIZET approval expected in first half of 2026.
During the year ended December 31, 2023, we issued 3,312,908 shares of common stock resulting in net proceeds of approximately $4.4 million after deducting $0.4 million of underwriting discounts and commissions and other expenses, pursuant to the 2023 ATM Program. We may continue to use the 2023 ATM Program to address potential short-term or long-term funding requirements that may arise.
We may continue to use the 2023 ATM Program to address potential short-term or long-term funding requirements that may arise. Such program will continue to be subject to the volatility of the price of our common stock and general market conditions.
NEXLETOL was approved by the FDA in February 2020 and received an expanded cardiovascular risk reduction indication from the FDA in March 2024. NEXLIZET contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.
NEXLETOL was approved by the FDA in February 2020, with the label expanded to include an indication for cardiovascular risk reduction March 2024, and received a subsequent update to the cardiovascular risk reduction indication in November 2025 to encompass all components of the primary composite endpoint from CLEAR Outcomes.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

5 edited+0 added−0 removed4 unchanged
Biggest changeOur 2030 Notes, which were issued in December 2024, carry a fixed rate of 5.75%. Our Loan, which was issued in December 2025, carries a fixed interest rate of 9.75%. Since both convertible notes and the Loan bear interest at a fixed rate, we have no direct financial statement risk associated with changes in interest rates.
Biggest changeOur Loan, which was issued in December 2025, carries a fixed interest rate of 9.75%. Since the convertible notes and the Loan bear interest at a fixed rate, we have no direct financial statement risk associated with changes in interest rates.
We do not believe that inflation has had a material effect on our results of operations during the year ended December 31, 2024. Our outstanding warrants currently have an exercise price of $1.55 per share and holders of such warrants may not exercise if the market price of our common stock is below $1.55.
We do not believe that inflation has had a material effect on our results of operations during the year ended December 31, 2025. Our outstanding warrants currently have an exercise price of $1.55 per share and holders of such warrants may not exercise if the market price of our common stock is below $1.55.
We do not believe a change in interest rate has had a material effect on our results of operations during the year ended December 31, 2024. Item 8. Financial Statements and Supplementary Data The financial statements required to be filed pursuant to this Item 8 are appended to this report.
We do not believe a change in interest rate has had a material effect on our results of operations during the year ended December 31, 2025. Item 8. Financial Statements and Supplementary Data The financial statements required to be filed pursuant to this Item 8 are appended to this report.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk We had cash and cash equivalents of approximately $144.8 million at December 31, 2024. The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk We had cash and cash equivalents of approximately $167.9 million at December 31, 2025. The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk.
As a result, we may be unable to obtain potential proceeds from the exercise of these warrants if the market price of our common stock does not exceed $1.55 per share. Our 2025 Notes, which were issued in November 2020, carry a fixed interest rate of 4.0% per year.
As a result, we may be unable to obtain potential proceeds from the exercise of these warrants if the market price of our common stock does not exceed $1.55 per share. Our 2030 Notes, which were issued in December 2024, carry a fixed rate of 5.75%.

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