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Esperion Therapeutics: Still An Attractive Risk/Reward Narrative As The Earnings Clock Ticks Toward Profitability
Seeking Alpha· 2025-11-10 12:24
Esperion Therapeutics, Inc. ( ESPR ) continues to execute under a cloud of market skepticism. While the stock has made an impressive recovery from the depths of skepticism in April and May, ESPR remains capped by important technical levelsDr. Duru has blogged about financial markets since the year 2000. A veteran of the dot-com bubble and bust, the financial crisis, and the coronavirus pandemic, he fully appreciates the value in trading and investing around the extremes of market behavior. In this spirit, h ...
ESPR's Q3 Earnings Lag Estimates, Revenues Rise Y/Y, Stock Down
ZACKS· 2025-11-07 17:25
Core Insights - Esperion Therapeutics (ESPR) reported a loss of $0.16 per share in Q3 2025, which was wider than the Zacks Consensus Estimate of a loss of $0.09 and compared to a loss of $0.15 per share in the same quarter last year [1][8] - The company generated total revenues of $87.3 million in Q3, marking a 69% year-over-year increase and surpassing the Zacks Consensus Estimate of $83 million [1][8] Financial Performance - Product revenues from the United States totaled $40.7 million in Q3, reflecting a 31% year-over-year increase but missing the Zacks Consensus Estimate of $42.9 million [7] - Collaboration revenues reached $46.7 million in Q3, up 128% year-over-year, driven by increased royalty sales and product sales to collaboration partners, beating the Zacks Consensus Estimate of $40.5 million [9] - Research and development expenses increased by 36% year-over-year to $14.1 million, while selling, general, and administrative expenses rose by 5% to $41.8 million due to higher legal and media costs [10] Future Outlook - Esperion expects operating expenses for 2025 to be in the range of $215-$235 million, including $15 million in non-cash stock compensation expenses, and aims for sustainable profitability by Q1 2026 [12] - The company has nominated ESP-2001, an allosteric ATP citrate lyase inhibitor, for preclinical development targeting primary sclerosing cholangitis, with plans to initiate IND-enabling studies and submit an IND application in 2026 [13] Recent Developments - Esperion reached a settlement with Dr. Reddy's regarding patents for Nexletol and Nexlizet, preventing the launch of generic versions in the U.S. before April 19, 2040, under certain conditions [14][15] - The company has two FDA-approved drugs, Nexletol and Nexlizet, for treating elevated LDL-C and cardiovascular risk reduction, marketed as Nilemdo and Nustendi in ex-U.S. markets [5][6] Stock Performance - Shares of Esperion fell by 15% on November 6, likely due to mixed Q3 results, despite a year-to-date increase of 13.7%, outperforming the industry average rise of 3.7% [2][4]
Esperion(ESPR) - 2025 Q3 - Quarterly Report
2025-11-06 21:10
Financial Performance - The company reported net losses of $31.3 million and $84.5 million for the three and nine months ended September 30, 2025, compared to $29.5 million and $30.4 million for the same periods in 2024, indicating ongoing financial challenges [166]. - The company has never been profitable and may need additional financing to support ongoing operations and product development [166]. - For the nine months ended September 30, 2025, net cash used in operating activities was $58.3 million, compared to a net cash provided of $11.3 million for the same period in 2024 [214]. - The company anticipates ongoing operating losses due to substantial expenses related to the commercialization of NEXLETOL and NEXLIZET, as well as research and development activities [210]. - Interest expense for Q3 2025 was $22.1 million, an increase of $7.0 million from $15.1 million in Q3 2024, primarily due to interest on the term loan [193]. - Interest expense for the nine months ended September 30, 2025 was $62.0 million, an increase of approximately $19.2 million from $42.8 million in the same period of 2024, primarily due to interest on the term loan [201]. Product Development and Efficacy - NEXLETOL demonstrated an average 20.0% placebo-corrected LDL-C lowering in the CLEAR Outcomes trial, resulting in a 13% lower risk of major cardiovascular events versus placebo [167]. - NEXLIZET lowered LDL-C by a mean of 38% compared to placebo when added to maximally tolerated statins, showcasing its efficacy in cholesterol management [168]. - The FDA approved expanded indications for NEXLETOL and NEXLIZET in March 2024, enhancing their market potential [163]. - NILEMDO received an expanded indication from the EC in May 2024 to reduce cardiovascular risk in patients with or at high risk for ASCVD [169]. - The company continues to focus on commercializing NEXLETOL and NEXLIZET in the U.S. while pursuing other research and development activities [170]. Revenue and Sales - Product sales, net for Q3 2025 were $40.7 million, an increase of $9.6 million from $31.1 million in Q3 2024, primarily due to prescription growth of NEXLETOL and NEXLIZET [188]. - Collaboration revenue for Q3 2025 was $46.7 million, up approximately $26.2 million from $20.5 million in Q3 2024, driven by increased royalty sales growth and product sales to collaboration partners [189]. - Collaboration revenue for the three and nine months ended September 30, 2025, was primarily related to sales of bulk tablets and royalty revenue from collaboration partners [175]. - Product sales, net for the nine months ended September 30, 2025 were $115.8 million, an increase of approximately $31.6 million from $84.2 million in the same period of 2024 [196]. - Collaboration revenue for the nine months ended September 30, 2025 was $118.8 million, a decrease of $60.2 million from $179.0 million in the same period of 2024, mainly due to a prior settlement agreement [197]. Expenses and Costs - The company incurred $8.8 million in expenses related to ongoing clinical studies during the nine months ended September 30, 2025, up from $5.6 million in the same period of 2024 [172][173]. - Cost of goods sold for Q3 2025 increased to $41.3 million from $17.3 million in Q3 2024, an increase of $24.0 million, mainly due to higher product sales to collaboration partners [190]. - Cost of goods sold for the nine months ended September 30, 2025 was $101.4 million, an increase of $58.4 million from $43.0 million in the same period of 2024, attributed to increased product sales [198]. - Selling, general and administrative expenses for Q3 2025 were $41.8 million, up approximately $1.8 million from $40.0 million in Q3 2024, mainly due to increased legal and media costs [192]. - Research and development expenses for Q3 2025 were $14.1 million, an increase of $3.7 million from $10.4 million in Q3 2024, primarily due to costs for ongoing clinical studies [191]. Financing and Capital Structure - The company completed an underwritten public offering of 56,700,000 shares at $1.50 per share, resulting in net proceeds of approximately $90.7 million after deducting $7.1 million in underwriting discounts and expenses [208]. - The company issued $100.0 million in 5.75% Convertible Senior Subordinated Notes due in June 2030, exchanging approximately $210.1 million of 2025 Notes [209]. - The company entered into a Credit Agreement for a $150.0 million term loan, which was fully borrowed at closing, with an annual interest rate of 9.75% if paid in cash [220]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $6.0 million, primarily from the 2023 ATM program [216]. - The company repurchased Revenue Interests for $343.8 million, eliminating future payment obligations under the Revenue Interest Purchase Agreement [223]. Future Outlook and Risks - The company expects research and development expenses to increase in 2025 as it begins its phase III pediatric trial and progresses its preclinical pipeline [179]. - Current cash resources and future proceeds from product sales and collaboration agreements are estimated to be sufficient to fund operations for the foreseeable future [228]. - Future funding requirements will depend on various factors, including the successful development and commercialization of product candidates [230]. - The company anticipates financing cash needs through collaborations, strategic alliances, licensing arrangements, debt financings, and equity offerings [229]. - Potential dilution of stockholder ownership may occur if additional capital is raised through equity or convertible debt securities [229]. - The company may need to relinquish valuable rights to technologies or future revenue streams through collaborations or licensing arrangements [231]. - Adverse macroeconomic conditions could materially affect the ability to consummate equity or debt financing on favorable terms [231]. - There have been no off-balance sheet arrangements as defined by SEC rules during the reported periods [232]. - No material changes have occurred regarding market risk disclosures since the last annual report [233].
Esperion(ESPR) - 2025 Q3 - Earnings Call Transcript
2025-11-06 14:00
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 grew 69% year over year to $87.3 million [4][18] - U.S. net product revenue increased 31% year over year to $40.7 million [4][18] - Collaboration revenue rose approximately 128% to $46.7 million compared to the same period in 2024 [18] Business Line Data and Key Metrics Changes - U.S. prescription growth saw nearly double-digit sequential growth, contributing to the overall revenue increase [4] - Average approval rate for Medicare coverage reached 87%, with out-of-pocket costs reduced significantly [10][11] - Total retail prescription equivalents increased by 9% from Q2 2025, with a 7% increase in the number of healthcare professionals prescribing Nexletol and Nexlizet [12] Market Data and Key Metrics Changes - The company outpaced the broader adjunct lipid-lowering market, achieving growth that exceeded all other non-statin products [6] - Royalty revenue from Daiichi Sankyo Europe increased 21% sequentially to $16.4 million [14] Company Strategy and Development Direction - The company is focused on expanding patient access programs and enhancing marketing strategies to drive future growth [4][5] - Strategic agreements with four generic manufacturers were finalized to protect the long-term value of its products [5] - The inclusion of bempedoic acid in ESC/EAS guidelines is expected to support expanded utilization and reinforce the company's market position [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustainable profitability by Q1 2026, despite one-time costs impacting net income [24] - The company anticipates continued growth momentum driven by strong execution and strategic investments [21][31] Other Important Information - The company closed a $75 million follow-on equity offering to ensure adequate capital for future developments [20] - The launch of Nexletol in Japan is expected to occur shortly after final pricing approval, which is anticipated within weeks [31][15] Q&A Session Summary Question: What were the drivers behind the gross margins for this quarter? - Gross margin drivers included low-margin tablet sales to partners, with expectations for improvement in 2026 as manufacturing is transferred [22] Question: Can you comment on achieving sustainable profitability in Q1 of 2026? - Management confirmed tracking in line with forecasts for sustainable ongoing profitability, with many Q3 expenses being one-time or non-recurring [24] Question: Regarding reimbursement per script, why were U.S. revenues flat despite a 9% increase in scripts? - One-time investments were made to secure preferred access with Medicare plans, impacting short-term revenue but expected to benefit future growth [25][27] Question: What feedback has been received regarding the ESC/EAS guidelines? - Positive feedback from partners indicates excitement among physicians regarding the guidelines, which are expected to enhance market reception [30] Question: What is the status of the 340B utilization of Nexletol and Nexlizet? - 340B utilization is minimal and not expected to impact revenue outlook [33] Question: What is the plan for the PSC pipeline and IND filing? - The company is in the planning phase for the PSC pipeline and aims to move quickly due to the high unmet need [34]
DoorDash Posts Downbeat Q3 Earnings, Joins elf Beauty, Duolingo, HubSpot And Other Big Stocks Moving Lower In Thursday's Pre-Market Session - Acadia Healthcare Co (NASDAQ:ACHC), ACV Auctions (NYSE:ACV
Benzinga· 2025-11-06 13:27
U.S. stock futures were mixed this morning, with the Nasdaq futures gaining around 0.1% on Thursday.Shares of DoorDash Inc (NASDAQ:DASH) fell sharply in pre-market trading after the company reported mixed third-quarter financial results.DoorDash reported quarterly earnings of 55 cents per share, which missed the consensus estimate of 68 cents by 19.24%. Quarterly revenue clocked in at $3.44 billion, which beat the analyst consensus estimate of $3.35 billion.DoorDash shares dipped 10.5% to $213.00 in pre-mar ...
Esperion Therapeutics (ESPR) Reports Q3 Loss, Tops Revenue Estimates
ZACKS· 2025-11-06 13:11
Esperion Therapeutics (ESPR) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to a loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -77.78%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.17 per share when it actually produced a loss of $0.02, delivering a surprise of +88.24%.Over the last four quarte ...
Esperion(ESPR) - 2025 Q3 - Earnings Call Presentation
2025-11-06 13:00
Q3 2025 Earnings Presentation November 6, 2025 © 2025 Esperion Therapeutics, Inc. All rights reserved. Forward-looking Statements & Disclosures This investor presentation contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding marketing strategy and commercialization plans, current and planned operational expenses, expected profitability, future operations, commercial products, clinical development, plans for pot ...
Esperion(ESPR) - 2025 Q3 - Quarterly Results
2025-11-06 12:32
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 Dysl ...
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 Appoints Industry Veteran John Harlow as Chief Commercial Officer
Globenewswire· 2025-11-04 13:00
Core Insights - Esperion has appointed John Harlow as Chief Commercial Officer, effective November 17, 2025, to enhance sales and marketing performance during a critical growth phase for the company [1][2] Company Overview - Esperion Therapeutics is a commercial stage biopharmaceutical company focused on developing and marketing innovative medicines for patients at risk of cardiovascular disease, specifically targeting elevated low-density lipoprotein cholesterol (LDL-C) [5] - The company has developed the only FDA-approved oral, once-daily, non-statin medications for this patient group, supported by the CLEAR Cardiovascular Outcomes Trial involving nearly 14,000 patients [5] Leadership Appointment - John Harlow brings over two decades of senior leadership experience in the pharmaceutical industry, having previously served as Chief Commercial Officer at Melinta Therapeutics, where he nearly doubled revenue with an 85% growth in 2024 compared to 2020 [2] - Harlow's extensive background includes roles at Baudax Bio, Recro Pharma, Endo Pharmaceuticals, Shionogi USA, Pfizer, Alpharma, and Novartis, as well as experience as an equity research analyst at Bank of America Merrill Lynch [2] Strategic Goals - Harlow's leadership is expected to drive the expansion of Esperion's product adoption in the U.S. and enhance its global presence, particularly in delivering cardiovascular risk reduction therapies [2][4] - The company aims to leverage Harlow's expertise to accelerate growth and improve access to its therapies, NEXLETOL and NEXLIZET, which are designed to manage cardiovascular risk [4]