Esperion Reports Third Quarter 2025 Financial Results and Provides Business Update

– Q3 2025 Total Revenue Grew 69% Y/Y to $87.3 Million –

– Q3 2025 U.S. Net Product Revenue Grew 31% Y/Y to $40.7 Million –

– Reached Settlement Agreement with ANDA Filer, Dr. Reddy’s Laboratories, Not to Market Generic Versions of NEXLETOL® (bempedoic acid) and NEXLIZET®(bempedoic acid and ezetimibe) Prior to April 2040 –

– Bempedoic Acid Received Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidemias –

– Partner Otsuka Received Regulatory Approval and Favorable Preliminary Pricing to Market NEXLETOL in Japan, Which Will Trigger Significant Milestone Payments Upon Final Pricing Approval –

– Conference Call and Webcast Today at 8:00 a.m. ET –

ANN ARBOR, Mich., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the third quarter ended September 30, 2025, and provided a business update.

"Our third quarter performance reflects consistently strong execution across our commercial, clinical, and global expansion strategies. We delivered robust year-over-year revenue growth, driven by increased U.S. prescription volume and expanded payer coverage, now reaching over 90% of commercial lives and more than 80% of Medicare lives. The recent settlement agreement with Dr. Reddy’s, along with earlier settlements with three other ANDA filers, supports our ability to build and maintain our market leadership for many years to come. We’re seeing strong momentum in healthcare practitioner engagement and patient access, driven by innovative consumer campaigns and a strategic focus on statin intolerance. We’re building on this success through targeted investments that expand our commercial momentum,” stated Sheldon Koenig, President and CEO of Esperion.

“The inclusion of bempedoic acid as a Class I, Level A recommendation in the 2025 ESC/EAS guidelines marks a pivotal moment in cardiovascular risk management. We believe this recognition will be reflected similarly in the upcoming U.S. guidelines expected in the first quarter of 2026. In anticipation of this and our extended patent runway, throughout the third quarter we invested in enhanced payer access, expanded sales and marketing initiatives, and patient access programs to ensure that we are leveraging these advantages to drive revenue growth and build a blockbuster franchise,” continued Mr. Koenig.

Third Quarter 2025 Key Accomplishments and Recent Highlights

Advancing the U.S. Commercial Strategy

Reached settlement agreements with four ANDA filers, including Dr. Reddy’s Laboratories, not to market generic version of bempedoic acid until 2040.Appointed industry veteran John Harlow as Chief Commercial Officer.The Company’s differentiated cardiovascular (CV) risk reduction data in primary prevention and statin intolerance continues to resonate with healthcare providers to drive prescriptions and revenue.

Established strong branding within statin intolerant population with new marketing campaign focused on, “Can’t take a statin? Make NEXLIZET happen!”“Lipid Lurkers” campaign awarded “Best CGI Category” at the Creative Floor Awards in London last month.Launched the Company’s first ever Direct to Consumer promotional ad on connected TV platforms such as Disney Streaming and Hulu.Company to host a virtual investor Key Opinion Leader Event on the role of bempedoic acid for the treatment of statin intolerant patients on November 11, 2025, featuring discussion with lipidology experts. To join the webinar, register here.Strengthened access and reimbursement support for NEXLETOL and NEXLIZET and now have greater than 90% of commercial lives and more than 80% of Medicare beneficiaries covered, with all national commercial and Medicare payers covering all indications.Increased total retail prescription equivalents by approximately 9% and grew the number of healthcare practitioners writing prescriptions for NEXLETOL and NEXLIZET to more than 30,000 in the third quarter of 2025. Esperion is laying the foundation to leverage the expected inclusion of bempedoic acid in the updated U.S. guidelines for the management of dyslipidemias in early 2026 by increasing patient access through patient support programs, market access contract activation, engagement with integrated delivery networks and direct-to-consumer initiatives.

Global Expansion

Daiichi Sankyo Europe, Esperion’s strategic partner in the region, continues to deliver robust revenue growth and expand market share for both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid and ezetimibe).

Bempedoic acid was included as a Class I, Level A recommendation in the 2025 ESC/EAS guidelines, which supports its expanded utilization across the 30 countries of the European Union.NILEMDO launched in Denmark, Sweden and Finland.Royalty revenue increased 21% sequentially to $16.4 million, continuing to underscore the ongoing opportunity in Europe for sales of NILEMDO and NUSTENDI.In August 2025, DSE announced the development of oral triple combination lipid-lowering tablets, with SANTORINI simulations showing improved LDL-C goal attainment aligned with the 2025 ESC/EAS guidelines.In September 2025, the Company’s partner in Japan, Otsuka Pharmaceutical Co., Ltd. received approval from the Japanese Ministry of Health, Labour and Welfare to market NEXLETOL as a treatment for hypercholesterolemia and familial hypercholesterolemia.

In November 2025, Otsuka received favorable preliminary pricing approval from the National Health Insurance in Japan, which will trigger significant milestone payments from Otsuka upon final pricing approval.HLS Therapeutics, Esperion’s commercial partner for NEXLETOL and NEXLIZET in Canada, has filed New Drug Submissions to Health Canada and remains on track for expected market approval by year-end 2025.Esperion continues to expect its partner in Israel, Neopharm Israel, to receive regulatory approval to market NEXLETOL and NEXLIZET in the first half of 2026.CSL Seqirus, the Company’s partner in Australia and New Zealand, filed a marketing application in Australia for NEXLETOL and NEXLIZET in July 2025, and expects market approval in Q4 2026.

R&D Pipeline

Nominated ESP-2001, the Company’s highly specific allosteric ATP citrate lyase inhibitor, as preclinical development candidate for the treatment of primary sclerosing cholangitis (PSC).Esperion began Investigational New Drug-enabling studies with a goal to file an IND with the U.S. Food and Drug Administration (FDA) to initiate first-in-human clinical studies in 2026.With an estimated prevalence of approximately 76,000 diagnosed PSC patients across the U.S. and Europe, and with no approved treatment options, ESP-2001 – a wholly owned asset for which Esperion retains exclusive global development and commercialization rights – represents a potential blockbuster market opportunity of over $1 billion annually.ESP-2001 has potential eligibility for Orphan Drug and Fast Track designations from the U.S. FDA, as well as PRIME designation from the European Medicines Agency.

Publications

Ray KK, et al. “Association of Uric Acid-Lowering Therapies on Gout Frequency with Bempedoic Acid: Clinical Insights from CLEAR Outcomes” published in JACC: Advances:

Post-hoc analysis of CLEAR Outcomes demonstrated incidence of gout with bempedoic acid was comparable to placebo in patients with no history of gout and a normal baseline uric acid level.While bempedoic acid was associated with higher incidence of gout in patients with elevated uric acid at baseline, gout was less pronounced when uric acid-lowering medications were used, suggesting that clinically indicated monitoring and treatment initiation may reduce potential risk of gout in patients receiving bempedoic acid.Nicholls SJ, et al. “Cost Effectiveness of Bempedoic Acid in High Cardiovascular Risk Patients with Statin Intolerance: An Analysis of the CLEAR Outcomes Trial” published in American Journal of Cardiovascular Drugs:

This economic model demonstrated that treatment with bempedoic acid provides improved lifetime CV risk reduction over standard of care, resulting in a substantial net benefit over standard of care in primary and secondary prevention patients: in the base case, there were 366 fewer lifetime major adverse cardiac events (MACE) per every 1000 patients with bempedoic acid compared with standard of care.At payer prices, the incremental cost-effectiveness ratio (ICER) for bempedoic acid was well below the threshold commonly used in the US of