Esperion Therapeutics, Inc.

Esperion Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on developing and commercializing oral, once-daily, non-statin medicines for patients at risk for cardiovascular disease (CVD) and elevated low-density lipoprotein cholesterol (LDL-C). The company's strategy, termed Vision 2040, involves executing a strategic commercialization plan for its approved products, advancing its preclinical pipeline, and broadening its company beyond the bempedoic acid franchise through business development activities to commercialize additional products in the United States ⁶.

The core business model revolves around generating revenue from product sales of NEXLETOL and NEXLIZET in the U.S. and collaboration revenue from international partnerships for the development and commercialization of its product candidates. Collaboration revenue also includes royalty revenue and sales of bulk tablets to partners ¹². The primary customer segments are patients at risk for cardiovascular disease and struggling with elevated LDL-C, including those with established CVD, at high risk for a CVD event, and those with primary hyperlipidemia, particularly individuals unable or unwilling to take recommended statin therapy ⁶.

NEXLETOL (bempedoic acid) tablets are a first-in-class ATP Citrate Lyase (ACLY) inhibitor that lowers LDL-C and cardiovascular risk by reducing cholesterol biosynthesis and up-regulating LDL receptors. It was approved by the FDA in February 2020, with expanded indications for cardiovascular risk reduction and expanded LDL-C lowering in primary and secondary prevention patients approved in March 2024, and a subsequent update to the cardiovascular risk reduction indication in November 2025 to encompass all components of the primary composite endpoint from CLEAR Outcomes ⁶. Phase 3 studies demonstrated an average 18% placebo-corrected LDL-C lowering when used with statins, and the CLEAR Outcomes trial showed a 20% placebo-corrected LDL-C reduction and a 13% lower risk of major cardiovascular events versus placebo in statin-intolerant patients ⁶.

NEXLIZET (bempedoic acid and ezetimibe) tablets combine bempedoic acid with ezetimibe, lowering elevated LDL-C through complementary mechanisms. It was approved by the FDA in February 2020, with expanded indications for cardiovascular risk reduction and expanded LDL-C lowering in primary and secondary prevention patients approved in March 2024, and a subsequent update to the cardiovascular risk reduction indication in November 2025 to encompass all components of the primary composite endpoint from CLEAR Outcomes ⁶. Phase 3 data showed NEXLIZET lowered LDL-C by a mean of 38% compared to placebo when added to maximally tolerated statins ⁶. In Europe, the products are marketed as NILEMDO (bempedoic acid) and NUSTENDI (bempedoic acid and ezetimibe), which received EC approval in March 2020 and expanded indications for cardiovascular risk reduction in May 2024 ⁶.

For the fiscal year ended December 31, 2025, the company recognized $159.6 million in net product sales of NEXLETOL and NEXLIZET ¹² and $243.6 million in collaboration revenue ¹². This collaboration revenue was primarily related to milestone payments from Otsuka, sales of bulk tablets under supply agreements, and royalty revenue received from collaboration partners ¹². The net loss for the year ended December 31, 2025, was $22.7 million ¹³, compared to $51.7 million in 2024 ¹³ and $209.2 million in 2023 ¹³. As of December 31, 2025, the company had an accumulated deficit of $1.6 billion ¹³. Research and development expenses for 2025 were $47.9 million ¹⁴.

Comparing year-over-year, net product sales of NEXLETOL and NEXLIZET increased from $78.3 million in 2023 to $115.7 million in 2024, and further to $159.6 million in 2025 ¹². Collaboration revenue saw a significant increase from $38.0 million in 2023 to $216.6 million in 2024, and then to $243.6 million in 2025 ¹². This substantial growth in collaboration revenue in 2024 was primarily due to a $100.0 million payment from DSE as part of a settlement agreement and a milestone from Otsuka upon the first Japanese New Drug Application submission ⁸⁵. The net loss decreased significantly from $209.2 million in 2023 to $51.7 million in 2024, and further to $22.7 million in 2025 ¹³.

Significant operational developments during the period include the FDA approval of expanded indications for NEXLETOL and NEXLIZET in March 2024, and a subsequent label update in November 2025 to encompass all components of the primary composite endpoint from CLEAR Outcomes ⁶. The EC also approved expanded indications for NILEMDO and NUSTENDI in May 2024 ⁶. Otsuka received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL in September 2025, with NHI pricing received in the fourth quarter of 2025 ⁶. The company filed supplemental NDAs for product approvals in Canada in November 2024, with NEXLETOL receiving approval in the fourth quarter of 2025 and NEXLIZET approval expected in the first half of 2026 ⁶. Collaboration partners filed in Israel in March 2025, with expected approval in the first half of 2026, and in Australia in July 2025, with expected approval in the fourth quarter of 2026 ⁶. The company also entered into a license and distribution agreement with HLS Therapeutics Inc. in May 2025 for exclusive commercialization rights in Canada ¹⁴. In December 2024, the company entered into privately negotiated exchange and subscription agreements with certain holders of its outstanding 2025 Notes, issuing $100.0 million aggregate principal amount of 5.75% Convertible Senior Subordinated Notes due 2030 ⁸⁸. The company also entered into a credit agreement for a $150.0 million term loan in December 2024 ⁶⁷. The DSE litigation was resolved in January 2024 with DSE agreeing to pay an aggregate of $125.0 million, including a $100.0 million payment within 15 business days of the effective date and a $25.0 million payment following EMA decision on the application for cardiovascular risk reduction ⁸⁵. The company also reached settlement agreements with several ANDA filers, agreeing not to market generic versions of NEXLETOL and/or NEXLIZET prior to April 19, 2040 ⁸⁶.

Management expects research and development expenses to remain consistent in 2026 due to the continuation of its phase III pediatric trial and the continuing advancement of its preclinical pipeline ¹⁴. Selling, general, and administrative expense in 2026 is also expected to remain consistent with 2025, as the company continues marketing and promotional activities related to the expanded cardiovascular outcomes indication received in March 2024 for NEXLETOL and NEXLIZET ¹⁴.

The company anticipates significant growth potential for NEXLETOL and NEXLIZET in the United States due to label expansions and promotional efforts, with additional, commensurate growth potential in Europe and other territories driven by its partners' efforts ⁶. The company is also advancing its preclinical pipeline, including next-generation ATP Citrate Lyase (ACLY) inhibitors, which have potential for broad therapeutic application beyond dyslipidemia and ASCVD, such as type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic associated steatohepatitis (MASH) ⁹. Primary sclerosing cholangitis (PSC) has been selected as the lead indication for these next-generation inhibitors ⁹.

The company is actively engaging in business development activities to potentially leverage its existing commercial organization to help commercialize additional products in the United States, aiming to broaden its company beyond the bempedoic acid franchise ⁶. This includes seeking approval and launching commercial sales of bempedoic acid and the bempedoic acid / ezetimibe combination tablet in unpartnered territories outside of the U.S. by establishing additional collaborations ¹³.

The company's planned capital allocation includes continued investment in research and development, with expenses expected to remain consistent in 2026 at approximately $47.9 million ¹⁴. Selling, general, and administrative expenses are also expected to remain consistent with 2025 levels, supporting ongoing marketing and promotional activities for the expanded label ¹⁴. The company has a $150.0 million term loan, with quarterly interest-only payments for the first four years after the closing date, and thereafter, the loan will partially amortize in quarterly principal payments of 12.5% ⁶⁷. The outstanding balance of the loan is to be repaid on December 13, 2029 ⁶⁷. The company also has $100.0 million aggregate principal amount of 5.75% Convertible Senior Subordinated Notes due 2030 outstanding as of December 31, 2025 ⁶⁷. The company does not intend to pay dividends on its common stock in the foreseeable future, instead retaining future earnings for business development, operation, and expansion ⁸⁸.

Management explicitly flagged several structural headwinds and execution risks to its growth plan. These include the dependence on the success of two products, bempedoic acid and the bempedoic acid / ezetimibe combination tablet, with no assurance that commercialization efforts in the U.S. and by partners will be successful or generate expected revenues ³⁶. The company has limited operating history as a commercial company and limited experience in marketing and sales, and the commercial success of approved drugs depends on market acceptance by physicians, patients, and third-party payers ³⁶. Failure to obtain or maintain adequate coverage and reimbursement for products could limit marketability and revenue generation ³⁶. The company may need substantial additional capital in the future, and if unavailable, operations may be delayed, reduced, or ceased ³⁶. Manufacturing pharmaceutical products is complex and relies on third parties, increasing the risk of insufficient quantities at acceptable cost or quality ³⁶. The company also faces risks if it cannot adequately protect its proprietary technology or maintain issued patents, which could lead to direct competition ³⁶.

Geographic, regulatory, and macro factors identified as constraints include recently enacted and future legislation that may increase the difficulty and cost of obtaining marketing approval and commercializing drug candidates, potentially decreasing prices ³⁶. The company cannot be certain of obtaining approval for expanded indications from regulatory authorities in other territories or successfully commercializing products and future candidates in all territories ³⁶. Approved drugs are subject to ongoing post-marketing requirements, and non-compliance could lead to substantial penalties, including market withdrawal ³⁶. Relationships with customers and third-party payors are subject to anti-kickback, fraud and abuse, and other healthcare laws and regulations, which could expose the company to criminal sanctions, civil penalties, and reputational harm ³⁶. The pending acquisition with Corstasis Therapeutics Inc. may not be consummated, or anticipated benefits may not be realized or may take longer than expected, and integration difficulties are possible ³⁶. The company is also at an increased risk of securities class action litigation ³⁶.

The company faces material risks, including its almost complete dependence on the success of NEXLETOL and NEXLIZET, with no assurance of successful commercialization or revenue generation at expected levels ³⁶. There is a risk of failure to obtain or maintain adequate coverage and reimbursement for products, which could limit marketability and decrease revenue ³⁶. The company may need substantial additional capital, and if unavailable, operations could be delayed, reduced, or ceased ³⁶. Manufacturing reliance on third parties increases the risk of insufficient quantities at acceptable cost or quality ³⁶. Intellectual property protection is crucial, and failure to adequately protect proprietary technology or maintain issued patents could lead to direct competition ³⁶. Regulatory risks include recently enacted and future legislation increasing the difficulty and cost of obtaining marketing approval and commercialization, potentially decreasing prices ³⁶. Ongoing post-marketing requirements could lead to substantial penalties, including market withdrawal, for non-compliance ³⁶. Relationships with customers and third-party payors are subject to anti-kickback, fraud and abuse, and other healthcare laws, potentially exposing the company to criminal sanctions, civil penalties, and reputational harm ³⁶. The pending acquisition of Corstasis Therapeutics Inc. carries risks of non-completion, delayed or unrealized benefits, and integration difficulties ³⁶. The company is also at an increased risk of securities class action litigation ³⁶. The Credit Agreement contains a financial covenant to maintain minimum liquidity of $50.0 million ⁶⁷. The U.S. federal government experienced a shutdown from October 1, 2025, to November 12, 2025, suspending non-essential services ⁶¹. The EU's Artificial Intelligence Act, which entered into force on August 1, 2024, with most provisions effective on August 2, 2026, imposes significant obligations on providers and deployers of high-risk AI systems, with potential administrative fines of up to the higher amount of €10 million or 2% of worldwide turnover for non-compliance ⁴⁹.

Management's message to shareholders emphasizes a focus on the Vision 2040 roadmap, which centers on discovering, developing, and commercializing innovative medicines to improve patient outcomes. Key strategic priorities include the execution of a strategic commercialization plan to drive significant growth for currently approved products, leveraging label expansions and promotional efforts for NEXLETOL and NEXLIZET in the U.S., and relying on partners for commensurate growth in Europe and other territories ⁶. A second priority is to continue advancing the preclinical pipeline, specifically focusing on next-generation ACLY inhibitors with potential for broad therapeutic application beyond dyslipidemia and ASCVD, such as in type 2 diabetes and MASLD/MASH, with primary sclerosing cholangitis (PSC) identified as a lead indication ⁹. The third strategic priority is to broaden the company beyond the bempedoic acid franchise by engaging in business development activities to leverage the existing commercial organization for additional product commercialization in the United States ⁶. Management expects research and development expenses to remain consistent in 2026 due to the continuation of the phase III pediatric trial and ongoing preclinical pipeline work ¹⁴. Similarly, selling, general, and administrative expenses for 2026 are anticipated to be consistent with 2025, supporting continued marketing and promotional activities for the expanded cardiovascular outcomes indication of NEXLETOL and NEXLIZET ¹⁴.