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Esperion(ESPR) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:00
Financial Performance - Total revenue for Q3 2025 reached $87.3 million, a 69% year-over-year increase[7, 31] - U S net product sales for Q3 2025 were $40.7 million, representing a 31% year-over-year growth[7, 31] - Collaboration revenue increased by 128% year-over-year, reaching $46.7 million in Q3 2025[31] - Esperion closed a $75 million follow-on equity offering, resulting in net proceeds of approximately $72.6 million[31] Market Access and Expansion - Retail prescription equivalents increased by 9% quarter-over-quarter[8, 39] - The total prescriber base now exceeds 30,000 healthcare professionals[10] - Medicare coverage reached 87% and commercial coverage reached 86%[13] Guideline Recognition and Strategic Partnerships - Bempedoic acid received a Level 1a recommendation in the updated ESC/EAS Guidelines for Management of Dyslipidemia[8, 15] - Esperion has partnerships in over 40 countries globally, including Europe, Japan, Asia, South America, Israel, Australia & New Zealand, and Canada[19] Pipeline and Future Outlook - Triple Combination A and B are projected to have NDA filings in 2027[25] - The company expects market approval in Canada in Q4 2025[19]
Esperion Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 11:00
Core Insights - Esperion reported a total revenue growth of 69% year-over-year to $87.3 million for Q3 2025, driven by increased U.S. prescription volume and expanded payer coverage [1][12] - The company achieved a U.S. net product revenue increase of 31% year-over-year to $40.7 million in Q3 2025 [1][12] - Esperion's partner, Otsuka, received regulatory approval and favorable preliminary pricing for NEXLETOL in Japan, which will trigger significant milestone payments upon final pricing approval [1][11] Financial Performance - Total revenue for the three and nine months ended September 30, 2025, was $87.3 million and $234.7 million, respectively, compared to $51.6 million and $263.2 million for the same periods in 2024, marking a 69% increase and an 11% decrease, respectively [12][15] - U.S. net product revenue for the three and nine months ended September 30, 2025, was $40.7 million and $115.8 million, respectively, compared to $31.1 million and $84.2 million for the same periods in 2024, reflecting a 31% and 38% increase [12][15] - Collaboration revenue was $46.7 million and $118.8 million for the three and nine months ended September 30, 2025, respectively, compared to $20.5 million and $179.0 million for the same periods in 2024, indicating a 128% increase and a 34% decrease, respectively [12][15] Strategic Developments - The inclusion of bempedoic acid as a Class I, Level A recommendation in the 2025 ESC/EAS guidelines is expected to enhance its market position and utilization [3][5] - Esperion reached a settlement agreement with ANDA filer Dr. Reddy's Laboratories, preventing the marketing of generic versions of NEXLETOL and NEXLIZET until April 2040 [5][6] - The company has strengthened its branding and marketing efforts, particularly targeting the statin intolerant population, which has contributed to increased healthcare practitioner engagement [2][6] Research and Development - Esperion is advancing its R&D pipeline, including the nomination of ESP-2001 for the treatment of primary sclerosing cholangitis, which represents a potential market opportunity exceeding $1 billion annually [11][31] - The company is also focused on enhancing patient access through various support programs and market access initiatives in anticipation of updated U.S. guidelines for dyslipidemia management [7][11] Market Expansion - Esperion's strategic partner in Europe, Daiichi Sankyo Europe, continues to show robust revenue growth for NILEMDO and NUSTENDI, with a 21% sequential increase in royalty revenue to $16.4 million [11] - The company is on track for market approvals in Canada and Israel for NEXLETOL and NEXLIZET by the end of 2025 and the first half of 2026, respectively [11][12]
Esperion Reaches 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 19, 2040
Globenewswire· 2025-10-03 12:00
Core Insights - Esperion has entered into a settlement agreement with Dr. Reddy's Laboratories, resolving patent litigation regarding generic versions of NEXLETOL and NEXLIZET, preventing Dr. Reddy's from marketing these generics in the U.S. before April 19, 2040, unless specific circumstances arise [1] - The settlement with Dr. Reddy's follows previous agreements with Micro Labs USA, Hetero USA, and Accord Healthcare concerning their generic versions of NEXLETOL, ensuring no remaining challenges to the validity of U.S. Patent No. 7,335,799, which expires in December 2030 [2] - Ongoing patent litigation against other defendants remains, with uncertainty regarding the potential for generic versions of NEXLETOL and NEXLIZET to be marketed before the April 2040 date [3] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral medications for patients at risk for cardiovascular disease, specifically targeting elevated low-density lipoprotein cholesterol (LDL-C) [4] - The company is advancing its pre-clinical pipeline and aims to establish itself as a leading global biopharmaceutical entity through commercial execution and international partnerships [5]
Esperion Therapeutics, Inc. (ESPR) Presents At Cantor Global Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-08 02:17
Company Overview - Esperion Therapeutics is focused on commercializing life-saving medications, specifically NEXLIZET and NEXLETOL [3] - The company is also developing additional life-saving medications, with a recent R&D Day highlighting interesting compounds [3] Financial Performance - Esperion reported significant momentum in its Q2 results, showing double-digit growth across all metrics [3] Industry Engagement - The company had a successful presence at the European Society of Cardiology, which positively influenced its guidelines [3]
Esperion’s Bempedoic Acid Receives Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidaemias
Globenewswire· 2025-08-29 12:00
Core Insights - Bempedoic acid has received strong endorsement from the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) guidelines as the only non-statin recommended for lowering LDL-C and reducing cardiovascular risk [1][4] - The guidelines emphasize an early and aggressive approach to combination lipid-lowering therapy, which aligns with the company's strategy to develop oral triple combination therapies in the U.S. [1][5] Company Developments - Esperion's President and CEO highlighted the significance of the guideline recognition for both European and U.S. markets, indicating that it will inform upcoming U.S. cholesterol treatment guidelines [2] - The company is strategically positioned to lead in the development of the first oral lipid-lowering triple combination pill in the U.S., which aims to provide unprecedented LDL-C lowering and improved patient adherence [5][16] Product Information - NEXLIZET and NEXLETOL are indicated for patients unable to take statin therapy, with bempedoic acid recommended for achieving LDL-C goals [6][7] - The guidelines recommend the addition of bempedoic acid to maximally tolerated doses of statins for high-risk patients to achieve LDL-C goals [6] Clinical Evidence - The clinical benefits of bempedoic acid are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial, which validates its role in cardiovascular risk reduction [16]
Esperion (ESPR) Q2 Revenue Jumps 12%
The Motley Fool· 2025-08-06 03:57
Core Insights - Esperion Therapeutics reported higher-than-expected GAAP results for Q2 2025, with revenue of $82.4 million, surpassing analyst estimates of $63.05 million, and a narrowed GAAP EPS loss of $0.02 compared to the expected loss of $0.15 [1][2][12] - The company achieved positive operating income from ongoing operations for the first time, indicating progress towards sustainable profitability [1][7] Financial Performance - GAAP revenue increased by 11.6% year-over-year from $73.8 million in Q2 2024 to $82.4 million in Q2 2025 [2] - U.S. net product revenue rose 42.4% year-over-year to $40.3 million, reflecting strong uptake of NEXLETOL and NEXLIZET [2][5] - Collaboration revenue decreased by 7.4% year-over-year to $42.1 million, but recurring collaboration revenue more than doubled compared to Q2 2024 [2][6] - Operating expenses declined by 5.5% year-over-year to $67.4 million, with R&D expenses dropping 37% [2][7] Product and Market Strategy - Esperion focuses on developing oral therapies for cholesterol management, particularly for patients who cannot tolerate statins, with NEXLETOL and NEXLIZET as its main products [3][10] - The company aims to expand market reach through new regulatory approvals and updated treatment guidelines, emphasizing physician acceptance and insurance coverage [4][10] - Recent prescription activity increased, with a 10% rise in retail prescriptions filled compared to the previous quarter [5] Collaboration and International Growth - Collaboration revenue, which includes royalties and milestone payments, constituted over half of total revenue, with significant contributions from partnerships like Daiichi Sankyo [6] - Over 500,000 European patients have received Esperion's therapies through its partnership with Daiichi Sankyo, with further international approvals expected in Japan, Canada, Israel, and Australia [6][12] Future Outlook - The company has a cash balance of $86.1 million as of June 30, 2025, down from $144.8 million at the end of 2024, with management focused on achieving sustainable profitability by early 2026 [12][13] - Esperion is developing a triple-combination oral therapy for LDL-C lowering, expected to launch in 2027, which aims to provide high-efficacy cholesterol reduction in a single tablet [11]
Esperion Reaches Settlement Agreement with Third ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-07-08 12:00
Core Insights - Esperion has entered into a settlement agreement with Accord Healthcare Inc. to resolve patent litigation regarding the generic version of NEXLETOL, preventing Accord from marketing it in the U.S. before April 19, 2040, under certain conditions [1] - Ongoing patent litigation against other defendants related to NEXLETOL and NEXLIZET continues, with no assurance on the outcome regarding the marketing of generics before the same date [2] Company Overview - Esperion Therapeutics is a biopharmaceutical company focused on developing and commercializing FDA-approved oral, once-daily, non-statin medications for patients at risk of cardiovascular disease with elevated LDL-C levels, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [3] - The company is advancing its pre-clinical pipeline and developing next-generation ATP citrate lyase inhibitors (ACLYi) to create highly potent and specific inhibitors [3][4]
Esperion Reaches Settlement Agreement with Second ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-06-02 12:00
Core Insights - Esperion has entered into a settlement agreement with Hetero USA, resolving patent litigation related to the generic version of NEXLETOL, preventing Hetero USA from marketing the generic in the U.S. before April 19, 2040, unless specific circumstances arise [1] - Ongoing patent litigation against other defendants regarding NEXLETOL and NEXLIZET continues, with no assurance on the outcome or potential market entry of generics before the 2040 date [2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing new medicines for patients at risk for cardiovascular disease, specifically offering FDA-approved oral, once-daily, non-statin medications for elevated LDL-C [3] - The company is advancing its next-generation program aimed at developing ATP citrate lyase inhibitors (ACLYi), leveraging new insights for rational drug design and the creation of potent inhibitors [3][4] - Esperion is evolving into a leading global biopharmaceutical company through commercial execution, international partnerships, collaborations, and the advancement of its pre-clinical pipeline [4]
Esperion Reaches Settlement Agreement with ANDA Filer Not to Market Generic Version of NEXLETOL® (bempedoic acid) Prior to April 19, 2040
Globenewswire· 2025-05-12 12:00
Core Insights - Esperion has entered into a settlement agreement with Micro Labs USA, resolving patent litigation related to the generic version of NEXLETOL, preventing Micro Labs from marketing it in the U.S. before April 19, 2040, unless specific circumstances arise [1] - Ongoing patent litigation against other defendants regarding NEXLETOL and NEXLIZET continues, with no assurance of a generic version being marketed before the same date [2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing new medicines for patients at risk of cardiovascular disease, specifically offering FDA-approved oral, once-daily, non-statin medications for elevated LDL-C [3] - The company is advancing its pre-clinical pipeline and aims to evolve into a leading global biopharmaceutical entity through commercial execution and international partnerships [4]
Esperion Reports First Quarter 2025 Financial Results
Globenewswire· 2025-05-06 10:00
Core Insights - Esperion reported Q1 2025 total revenue of $65.0 million, a decrease of 53% year-over-year, but adjusted for a one-time milestone in Q1 2024, total revenue grew 63% year-over-year [1][15] - U.S. net product revenue increased by 41% year-over-year to $34.9 million [1][15] - Bempedoic acid received Level 1a recommendations in the 2025 ACC/AHA/ACEP/NAEMSP/SCAI guidelines for managing patients with Acute Coronary Syndromes [1][10] - The company expanded its development portfolio with a new program targeting Primary Sclerosing Cholangitis (PSC), a market estimated to exceed $1 billion [1][3] Financial Performance - Total revenue for Q1 2025 was $65.0 million, down from $137.7 million in Q1 2024, primarily due to a settlement agreement milestone received in the previous year [15][33] - U.S. net product revenue rose to $34.9 million from $24.8 million in the same period last year, marking a 41% increase [15][33] - Collaboration revenue fell to $30.1 million from $113.0 million year-over-year, a decrease of 73%, but grew 97% when excluding the milestone [15][33] - The company reported a net loss of $40.5 million compared to a net income of $61.0 million in Q1 2024 [13][33] Commercial Strategy - The company surpassed one million prescriptions for bempedoic acid products in the U.S. [3][6] - Esperion expanded its reimbursement team from five to 15 specialists to enhance support for healthcare providers and patients [6] - New marketing initiatives targeting statin-intolerant patients, who represent 30% of the lipid-lowering market, are expected to drive prescription growth [6][3] - The company is advancing two triple combination products for commercialization in 2027, which could provide LDL-C lowering in excess of 60% [6][3] Research and Development - Esperion hosted an R&D Day highlighting its capabilities and promising research for PSC treatment candidates [10][7] - Pre-clinical data showed that the company's allosteric ACLY inhibitor could reduce liver injury markers in PSC models [10][7] - The estimated prevalence of diagnosed PSC patients in the U.S. and Europe is approximately 76,000 as of 2024 [10][7] Market Positioning - Esperion's European partner, Daiichi Sankyo Europe, reported an 8% sequential increase in royalty revenue to $10.5 million, indicating strong market penetration for its products [10][6] - The company is on track for expected approval and pricing in Japan in the second half of 2025 [6][10]