ESPR Esperion Therapeutics Inc.

7.78
+0.09  (+1%)
Previous Close 7.69
Open 7.7
52 Week Low 6.97
52 Week High 39.495
Market Cap $226,221,837
Shares 29,077,357
Float 20,922,628
Enterprise Value $396,155,875
Volume 1,295,418
Av. Daily Volume 1,308,828
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Upcoming Catalysts

Drug Stage Catalyst Date
NEXLETOL (bempedoic acid) - (ETC-1002) CLEAR Outcomes
Cardiovascular Diseases
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
NEXLETOL (bempedoic acid) / Ezetimibe (1002-058)
LDL-C and type 2 diabetes
Phase 2
Phase 2
Phase 2 trial met primary endpoint - August 29, 2019.
NEXLETOL (bempedoic acid) / Ezetimibe
Hypercholesterolemia
Approved
Approved
FDA approval announced February 26, 2020.
NEXLETOL (bempedoic acid)
Hypercholesterolemia
Approved
Approved
FDA Approval announced February 21, 2020.

Latest News

  1. - Analysis of pooled Phase 3 data showed that NEXLETOL [bempedoic acid (BA)] alone lowered LDL-C levels comparable to that of a moderate- or high-intensity statin (≥ 30%) in nearly 1 out of 3 of patients -

    - In patients with metabolic syndrome NEXLETOL lowered hemoglobin A1c (HbA1c), fasting plasma glucose and low-density lipoprotein cholesterol (LDL-C), at week 12 -

    - In healthy patients treatment with BA reduced fasting LDL-C, non- high-density lipoprotein cholesterol (HDL-C), and baseline high-sensitivity C-reactive protein (hsCRP) at week 12 -

    ANN ARBOR, Mich., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the presentation of three abstracts highlighting NEXLETOL tablets at the American Heart Association (AHA…

    - Analysis of pooled Phase 3 data showed that NEXLETOL [bempedoic acid (BA)] alone lowered LDL-C levels comparable to that of a moderate- or high-intensity statin (≥ 30%) in nearly 1 out of 3 of patients -

    - In patients with metabolic syndrome NEXLETOL lowered hemoglobin A1c (HbA1c), fasting plasma glucose and low-density lipoprotein cholesterol (LDL-C), at week 12 -

    - In healthy patients treatment with BA reduced fasting LDL-C, non- high-density lipoprotein cholesterol (HDL-C), and baseline high-sensitivity C-reactive protein (hsCRP) at week 12 -

    ANN ARBOR, Mich., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the presentation of three abstracts highlighting NEXLETOL tablets at the American Heart Association (AHA) Scientific Sessions 2021 taking place on November 13-15, 2021.

    "As one of the few companies solely focused on LDL-C lowering in high-risk cardiovascular patients, Esperion continues to advance the science of lipid lowering and the value of our therapies. These presentations provide important new information for clinicians as they look to provide oral therapies to reduce LDL-C," said Dr. JoAnne Foody, chief medical officer of Esperion. "The data presented during AHA highlight not only the important LDL-C lowering benefits of bempedoic acid across multiple patient populations, but also highlight the potential cardiometabolic effects of our compounds with reductions in glucose and hsCRP. Bempedoic acid, through inhibition of the enzyme ATP citrate lyase pathway, uniquely acts at the interface of lipid and carbohydrate metabolism and offers promise for future targeting of patients with cardiometabolic risk."

    In the abstract, "Factors Associated with Enhanced Low-density Lipoprotein Cholesterol Lowering With Bempedoic Acid Among Patients Enrolled in Phase 3 Studies," LDL-C lowering with BA was examined using pooled data from four Phase 3 studies in 3,488 patients on background maximally tolerated statins. Overall, from baseline to Week 12, BA lowered LDL-C levels comparable to that of a moderate- or high-intensity statin (≥ 30%) in 28.9% of patients. In patients not receiving background statins, greater than 50% of patients achieved at least 30% LDL-C lowering with BA. A multivariate analysis showed that many factors, including the absence of baseline statin use, gender, history of diabetes mellitus, baseline ezetimibe (EZE), and higher hsCRP were associated with increased rates of achieving at least a 30% reduction in LDL-C with BA treatment (odds ratio [95% CI], 2.49 [1.94, 3.19; P < .0001).

    In "Efficacy and Safety of Bempedoic Acid in Patients With Metabolic Syndrome," pooled data from four Phase 3 studies were used to analyze the lipid-lowering efficacy, safety, and effect of BA on glycemic parameters and hsCRP according to baseline metabolic status. The analysis of 3,623 patients (excluding diabetes mellitus patients) determined the incidence of treatment emergent adverse events (TEAEs) was comparable in both subgroups. Overall, BA demonstrated comparable safety in both metabolic subgroups and greater lowering of LDL-C, HbA1c, and fasting plasma glucose (FPG) levels in patients with metabolic syndrome (MetS) vs nonMetS.

    The abstract, "Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in a Phase 1 Clinical Trial in Healthy Japanese, Chinese, and White Subjects," analyzed data from a double-blind, placebo-controlled study in a total of 40 healthy subjects randomized 3:1 to receive BA or placebo. Reductions in fasting LDL-C, non-HDL-C and hsCRP were observed with BA and the drug was well tolerated. PK differences were explained after normalizing by subject body weight and were not associated with any clinically meaningful differences in the efficacy or safety profiles of BA.

    Approved by the U.S. Food and Drug Administration (FDA), NEXLETOL is the first oral, once-daily, non-statin LDL-C-lowering medicine available to indicated patients in nearly 20 years. The approval of NEXLETOL was supported by a global pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000 patients with ASCVD and/or HeFH. In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering when used with moderate or high-intensity statins. NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not yet been determined. Please see important safety information below.

    NEXLETOL® (bempedoic acid) Tablet

    NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020, and by the European Commission in April 2020 under the name NILEMDO® (bempedoic acid) with a different label. Daiichi Sankyo Europe has licensed exclusive commercialization rights to bempedoic acid in the European Economic Area, Switzerland, Turkey, and United Kingdom, from Esperion.

    Important Safety Information

    • Warnings and Precautions:
      • Elevations in serum uric acid have occurred. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. The risk for gout events with NEXLETOL was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL who had no prior gout history.
      • Tendon rupture has occurred. Discontinue NEXLETOL at the first sign of tendon rupture. Avoid NEXLETOL in patients who have a history of tendon disorders or tendon rupture.
    • Adverse Reactions:
      • The most common (incidence ≥ 2% and greater than placebo) adverse reactions are upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes.
    • Drug Interactions:
      • Avoid concomitant use of NEXLETOL with simvastatin greater than 20 mg.
      • Avoid concomitant use of NEXLETOL with pravastatin greater than 40 mg.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Esperion at 833-377-7633 (833 ESPRMED).

    Please see the full Prescribing Information for NEXLETOL by clicking here.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our goal is lipid management for everybody, that's why we work hard to make our medicines easy to get, easy to take and easy to have. We discover, develop and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren't being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding commercialization plans. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the impact of COVID-19 on our business, clinical activities and results, supply chain, commercial development and launch plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

    Contact:

    Corporate Communications



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  2. – Recently Announced Transformative Plan to Align Operational and Expense Structure to the Current Environment and Position for Long-Term Growth –

    – Unprecedented CLEAR Outcomes Study Remains On-Track for Complete Major Adverse Cardiac Events (MACE) Accumulation in 2H 2022; Achieved 80% MACE Accumulation in October –

    – U.S. Net Product Revenue of NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets of $10.9 Million for the Third Quarter 2021 –

    – Prescriptions Grew 10% During the Quarter; More Than 59,200 Patients Have Filled a Prescription for NEXLETOL® (bempedoic acid) Tablets or NEXLIZET® (bempedoic acid and ezetimibe) Tablets –

    ANN ARBOR, Mich., Nov. 02, 2021 (GLOBE NEWSWIRE) --  Esperion (NASDAQ…

    – Recently Announced Transformative Plan to Align Operational and Expense Structure to the Current Environment and Position for Long-Term Growth –

    – Unprecedented CLEAR Outcomes Study Remains On-Track for Complete Major Adverse Cardiac Events (MACE) Accumulation in 2H 2022; Achieved 80% MACE Accumulation in October –

    – U.S. Net Product Revenue of NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets of $10.9 Million for the Third Quarter 2021 –

    – Prescriptions Grew 10% During the Quarter; More Than 59,200 Patients Have Filled a Prescription for NEXLETOL® (bempedoic acid) Tablets or NEXLIZET® (bempedoic acid and ezetimibe) Tablets –

    ANN ARBOR, Mich., Nov. 02, 2021 (GLOBE NEWSWIRE) --  Esperion (NASDAQ:ESPR) today reported financial results for the third quarter ended September 30, 2021 and provided a business update.

    "In the past months, we have made significant strides to align our organization and cost structure with the current environment, preserve flexibility for future scale-up and position Esperion for long-term growth as we advance our mission of making lipid management accessible and convenient for everyone," said Sheldon Koenig, president and CEO of Esperion. "We are now focusing on our most productive prescribers and strengthening our capabilities in non-personal promotion. We continued to observe positive momentum and growth in key commercial metrics and are invigorated to introduce these therapies to more patients as they resume engagement with their physicians. Looking ahead, our CLEAR Outcomes study remains on track for complete MACE accumulation in the second half of 2022, and to report topline results in Q1 2023. We remain optimistic that a positive study result will drive an inflection in the growth trajectory for NEXLETOL and NEXLIZET."

    Third Quarter 2021 and Recent Highlights

    • Announced transformative strategic plan to align Esperion's operational and expense structure to support the long-term growth of NEXLETOL and NEXLIZET
    • Achieved 80% MACE Accumulation in the CLEAR Outcomes Trial in October
    • Hosted investor webinar on the current landscape and future directions in the treatment of elevated cholesterol during National Cholesterol Awareness Month, featuring a discussion with world-renowned cardiologist Steven Nissen, M.D., from the Cleveland Clinic
    • Eliminated complete buy-down to align co-pay card program to industry standards
    • Partnered with Asembia, an accredited call-center of highly qualified clinical specialists and care coordinators that work hand-in-hand with prescribers, patients, payers and pharmacies throughout the patient journey, to launch a customized prescription support program to facilitate prescription fulfillment
    • Continued European rollout of NILEMDO® and NUSTENDI® with partner Daiichi Sankyo; over 28,000 patients now on therapy as of third quarter 2021
    • Entered into an agreement to exchange $15 million of Esperion convertible notes for common stock, strengthening the Company's capital position and providing future financial flexibility
    • Appointed Seth H.Z. Fisher to Esperion Board of Directors

    Third Quarter 2021 Financial Results

    U.S. net product revenue was $10.9 million for the third quarter of 2021 and $27.9 million for the nine months ended September 30, 2021, compared to $3.3 million and $4.8 million for the comparable periods in 2020. Royalty revenue for the third quarter 2021 was $1.2 million and $2.8 million for the nine months ended September 30, 2021. Total revenue for the third quarter ended September 30, 2021 was $14.4 million and $63.0 million for the nine months ended September 30, 2021, compared to $3.8 million and $217.9 million for the comparable periods in 2020. The increase in total revenue in the third quarter of 2021 was primarily attributable to prescription growth of NEXLETOL and NEXLIZET.

    Research and development expenses were $25.3 million for the third quarter of 2021 and $78.4 million for the nine months ended September 30, 2021, compared to $35.3 million and $105.0 million for the comparable periods in 2020. The decrease in expenses was primarily attributable to an overall reduction in ongoing clinical research activities, including compensation costs.

    Selling, general and administrative expenses were $39.3 million for the third quarter of 2021 and $146.6 million for the nine months ended September 30, 2021, compared to $48.8 million and $138.1 million for the comparable periods in 2020. The decrease in the third quarter of 2021 was primarily attributable to a decrease in commercial compensation expense.

    Esperion had net losses of $69.4 million for the third quarter of 2021 and $204.0 million for the nine months ended September 30, 2021, compared to net losses of $85.4 million and $39.1 million for the comparable periods in 2020. Esperion had basic and diluted net losses per share of $2.62 for the third quarter of 2021 and $7.78 for the nine months ended September 30, 2021, compared to basic and diluted net losses per share of $3.07 and $1.41 for the comparable periods in 2020.

    As of September 30, 2021, cash, cash equivalents, and restricted cash totaled $153.7 million ($50.0 million classified as restricted cash). As of December 31, 2020, cash and cash equivalents totaled $305.0 million.

    Esperion ended the quarter with approximately 26.8 million shares of common stock outstanding, excluding the 2.0 million treasury shares to be purchased in the prepaid forward transaction as part of the convertible debt financing with another 4.6 million issuable upon exercise of stock options and vesting of restricted stock units.

    2021 & 2022 Financial Outlook

    Research and Development expenses for the full year 2021 are expected to be $110 million to $115 million. Selling, General and Administrative expenses for the full year 2021 are expected to be $195 million to $200 million. Esperion expects full-year 2021 operating expenses to be approximately $305 million to $315 million, inclusive of $25 million of non-cash, stock-based compensation.

    Esperion anticipates Research and Development expenses for fiscal year 2022 to be $100 to $110 million and Selling, General and Administrative expenses for fiscal year 2022 to be $120 to $130 million. Esperion expects fiscal year 2022 operating expenses to be $220 to $240 million, inclusive of $25 million of non-cash, stock-based compensation expense.

    Conference Call and Webcast Information

    Esperion will host a conference call and webcast today, November 2, 2021 at 8:00 A.M. Eastern Time to provide a third quarter 2021 financial results and company update. The call can be accessed by dialing 877-831-3840 (domestic) or 253-237-1184 (international) five minutes prior to the start of the call and providing the access code 2646847.

    A live audio webcast can be accessed on the investors and media section of the Esperion website at investor.esperion.com. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the Esperion website for approximately 90 days.

    CLEAR Cardiovascular Outcomes Trial

    The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. Esperion initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered "statin averse." The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of over 14,000 patients with hypercholesterolemia and high CVD risk at over 1,200 sites in 32 countries.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our goal is lipid management for everybody, that's why we work hard to make our medicines easy to get, easy to take and easy to have. We discover, develop and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren't being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    Esperion Therapeutics' Commitment to Patients with Hyperlipidemia

    High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack and stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have elevated LDL-C. There are approximately 18 million people in the U.S. living with elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy — including individuals considered statin averse — leaving them at high risk for cardiovascular events1. In the United States, more than 50 percent of atherosclerotic cardiovascular disease (ASCVD) patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C levels with statins alone need less than a 40 percent reduction to reach their LDL-C threshold goal2.

    Esperion's mission as the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.

    Forward-Looking Statements

    This press release 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, restructuring and operational expenses, future operations, commercial products, clinical development including the timing, designs and plans for the CLEAR Outcomes study and its results, plans for potential future product candidates, financial condition and outlook, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the impact of the ongoing COVID-19 pandemic on our business, revenues, results of operations and financial condition, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

    References

    (1) Esperion market research on file: research project interviewing 350 physicians. Esperion Therapeutics, Inc. Sept-Oct 2018.

    (2) Data on file: analysis of NHANES database. Esperion Therapeutics, Inc. 2018.

    Contact:

    Ben Church

            

    734-864-6774

    Esperion Therapeutics, Inc.

    Balance Sheet Data

    (In thousands)

    (Unaudited)

      September 30,

    2021
     December 31,

    2020
    Cash and cash equivalents  $103,672    $304,962  
    Restricted cash 50,000     
    Working capital 92,183   251,827  
    Total assets 225,256   353,258  
    Revenue interest liability 247,568   176,604  
    Convertible notes, net of issuance costs 272,508   179,367  
    Common stock 27   26  
    Accumulated deficit (1,041,258)  (838,817) 
    Total stockholders' deficit (362,705)  (96,134) 

    Esperion Therapeutics, Inc.

    Statement of Operations

    (In thousands, except share and per share data)

    (Unaudited)

    Three Months Ended September 30, Nine Months Ended

    September 30,
    2021 2020 2021 2020
    Revenues:     
    Product sales, net$10,895   $3,331   $27,855   $4,798  
    Collaboration revenue3,514   502   35,191   213,111  
    Total Revenues14,409   3,833   63,046   217,909  
           
    Operating expenses:       
    Cost of goods sold5,558   275   9,142   704  
    Research and development25,331   35,283   78,359   104,972  
    Selling, general and administrative39,265   48,826   146,647   138,060  
    Total operating expenses70,154   84,384   234,148   243,736  
           
    Loss from operations(55,745)  (80,551)  (171,102)  (25,827) 
           
    Interest expense(13,654)  (4,928)  (32,923)  (13,739) 
    Other income, net13   42   36   491  
    Net loss$(69,386)  $(85,437)  $(203,989)  $(39,075) 
           
    Net loss per common share – basic and diluted$(2.62)  $(3.07)  $(7.78)  $(1.41) 
           
    Weighted-average shares outstanding – basic and diluted26,455,209   27,830,281   26,225,730   27,672,325  

     



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  3. ANN ARBOR, Mich., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the presentation of three abstracts at the American Heart Association (AHA) Scientific Sessions 2021 taking place on November 13-15, 2021.

    AHA Scientific Sessions 2021

    On Demand 
    Session Type:Oral Presentation #266
    Abstract Title:Factors Associated with Enhanced Low-density Lipoprotein Cholesterol Lowering with Bempedoic Acid Among Patients Enrolled in Phase 3 Studies
    Authors:Christie M. Ballantyne, MD; Harold E. Bays, MD; Jeremy Smart, PharmD; Yang Zhang, PhD; Kausik K. Ray, MD, MPhil
      
    Session Type:Oral Presentation #267
    Abstract Title:Efficacy and Safety of Bempedoic Acid in Patients with Metabolic Syndrome
    Authors:Michael D. Shapiro, DO, MCR; Pam R. Taub,

    ANN ARBOR, Mich., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the presentation of three abstracts at the American Heart Association (AHA) Scientific Sessions 2021 taking place on November 13-15, 2021.

    AHA Scientific Sessions 2021

    On Demand 
    Session Type:Oral Presentation #266
    Abstract Title:Factors Associated with Enhanced Low-density Lipoprotein Cholesterol Lowering with Bempedoic Acid Among Patients Enrolled in Phase 3 Studies
    Authors:Christie M. Ballantyne, MD; Harold E. Bays, MD; Jeremy Smart, PharmD; Yang Zhang, PhD; Kausik K. Ray, MD, MPhil
      
    Session Type:Oral Presentation #267
    Abstract Title:Efficacy and Safety of Bempedoic Acid in Patients with Metabolic Syndrome
    Authors:Michael D. Shapiro, DO, MCR; Pam R. Taub, MD; Michael J. Louie, MD, MPH, MSc; Lei Lei, PhD; Christie M. Ballantyne, MD
      
    Session Type:Oral Presentation #264
    Abstract Title:Pharmacokinetics, Pharmacodynamics, and Safety of Bempedoic Acid in a Phase 1 Clinical Trial in Healthy Japanese, Chinese, and White Subjects
    Authors:Benny M. Amore, PhD; Rujun Teng, MS; Jeffrey C. Hanselman, MS

    Bempedoic Acid

    INDICATION

    Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitations of Use: The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions: Hyperuricemia: Bempedoic acid may increase blood uric acid levels. Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.

    Tendon Rupture: Bempedoic acid is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with bempedoic acid versus 0% of patients treated with placebo, and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting bempedoic acid. Tendon rupture may occur more frequently in patients over 60 years of age, patients taking corticosteroid or fluoroquinolone drugs, patients with renal failure, and patients with previous tendon disorders. Discontinue bempedoic acid at the first sign of tendon rupture. Avoid bempedoic acid in patients who have a history of tendon disorders or tendon rupture.

    Adverse Reactions: In clinical trials, the most commonly reported adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes. Reactions reported less frequently, but still more often than with placebo, included benign prostatic hyperplasia and atrial fibrillation.

    Drug Interactions: Simvastatin and Pravastatin: Concomitant use results in increased concentrations and increased risk of simvastatin or pravastatin-related myopathy. Use with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.

    Lactation and Pregnancy: It is not recommended that bempedoic acid be taken during breastfeeding. Discontinue bempedoic acid when pregnancy is recognized, unless the benefits of therapy outweigh the potential risks to the fetus. Based on the mechanism of action, bempedoic acid may cause fetal harm.

    Please see full Prescribing Information here.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our goal is lipid management for everybody, that's why we work hard to make our medicines easy to get, easy to take and easy to have. We discover, develop and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren't being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    Forward-Looking Statements

    This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements relating to the expected closing of the exchange of the Notes pursuant to the Exchange Agreement and expectations regarding future transactions to further improve ESPERION's balance sheet. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. The inclusion of forward-looking statements should not be regarded as a representation by ESPERION that any of these results will be achieved. Actual results may differ from those set forth in this Report due to the risks and uncertainties associated with the satisfaction of closing conditions under the Exchange Agreement and with entering into additional exchange agreements, as well as risks and uncertainties described in ESPERION's filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this Report speak only as of the date hereof, and ESPERION disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. All forward-looking statements are qualified in their entirety by this cautionary statement.

    Contact:

    Corporate Communications



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  4. ANN ARBOR, Mich., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the appointment of Seth H.Z. Fischer as a Class III director, with a term expiring at the 2022 meeting of stockholders.

    "On behalf of the Esperion team and our directors, I am very pleased to welcome Seth to the Esperion board. His deep operational and commercial expertise will be especially relevant during this exciting and transformative time for our Company," said Sheldon Koenig, president and chief executive officer of Esperion. "Seth is a proven leader with a successful track record of developing and executing strategies to drive product growth, and we look forward to leveraging his counsel to further our mission.

    "I'm honored to join Esperion's…

    ANN ARBOR, Mich., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced the appointment of Seth H.Z. Fischer as a Class III director, with a term expiring at the 2022 meeting of stockholders.

    "On behalf of the Esperion team and our directors, I am very pleased to welcome Seth to the Esperion board. His deep operational and commercial expertise will be especially relevant during this exciting and transformative time for our Company," said Sheldon Koenig, president and chief executive officer of Esperion. "Seth is a proven leader with a successful track record of developing and executing strategies to drive product growth, and we look forward to leveraging his counsel to further our mission.

    "I'm honored to join Esperion's board of directors during this transformational time ahead of the read-out of the unprecedented CLEAR Outcomes trial," said Mr. Fischer. "The recent changes Esperion implemented position the company for long-term success, and I look forward to applying my previous experience to support Esperion's focused and driven team in ensuring the millions of patients who need additional LDL-C lowering options have access to our convenient, once-daily oral medicines."

    Mr. Fischer brings over 35 years of experience and a distinguished record of results in key leadership positions within the pharmaceutical and medical device industries. He currently serves as a member of the board of directors of Agile Therapeutics, Inc., Spectrum Pharmaceuticals, Inc., and Marinus Pharmaceuticals. Previously, Mr. Fischer served as the chief executive officer and as a director of Vivus, Inc., a publicly traded biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs from September 2013 to December 2017.

    Prior to Vivus, Mr. Fischer served in various positions of increasing responsibility at Johnson & Johnson, most recently as company group chairman, Johnson & Johnson and worldwide franchise chairman of Cordis Corporation. Before that, he served as company group chairman, North America Pharmaceuticals, which included responsibilities for Ortho-McNeil Pharmaceuticals, Janssen and Scios. Prior to that, Mr. Fischer served as president of Ortho-McNeil Pharmaceuticals. From May 2013 to May 2019, Mr. Fischer also served on the board of directors of BioSig Technologies, Inc.

    Mr. Fischer holds a Bachelor of General Studies from Ohio University and previously served as a captain in the U.S. Air Force.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our goal is lipid management for everybody, that's why we work hard to make our medicines easy to get, easy to take and easy to have. We discover, develop and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren't being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. We are singularly focused on managing cholesterol so you can improve your health easily. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    Forward-Looking Statements

    This press release 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, restructuring and operational expenses, future operations, commercial products, clinical development, plans for potential future product candidates, financial condition and outlook, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the impact of the ongoing COVID-19 pandemic on our business, revenues, results of operations and financial condition, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

    Contact:

    Esperion Media Relations

     



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  5. ANN ARBOR, Mich., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that members of Esperion's management team will participate in the upcoming Credit Suisse 30th Annual Healthcare Conference.

    Event:   Credit Suisse 30th Annual Healthcare Conference
    Date: Tuesday, November 9, 2021
    Format:  Fireside Chat and 1:1 Meetings
    Time:   4:20 p.m. ET

    Live audio webcasts of these events can be accessed on the investor relations section of the Esperion website at www.esperion.com/investors-media/events-presentations/. Replays of the webcasts will be archived on the Company's website for 90 days following the events.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our goal is lipid management for everybody, that's…

    ANN ARBOR, Mich., Oct. 27, 2021 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that members of Esperion's management team will participate in the upcoming Credit Suisse 30th Annual Healthcare Conference.

    Event:   Credit Suisse 30th Annual Healthcare Conference
    Date: Tuesday, November 9, 2021
    Format:  Fireside Chat and 1:1 Meetings
    Time:   4:20 p.m. ET

    Live audio webcasts of these events can be accessed on the investor relations section of the Esperion website at www.esperion.com/investors-media/events-presentations/. Replays of the webcasts will be archived on the Company's website for 90 days following the events.

    Esperion Therapeutics

    Esperion is The Lipid Management Company. Our goal is lipid management for everybody, that's why we work hard to make our medicines easy to get, easy to take and easy to have. We discover, develop and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren't being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

    Investor Contact:

    Kaitlyn Brosco

    Esperion

     



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