ESPR Esperion Therapeutics Inc.

32.81
-0.41  -1%
Previous Close 33.22
Open 33.13
52 Week Low 24.82
52 Week High 76.98
Market Cap $912,952,293
Shares 27,825,428
Float 23,917,761
Enterprise Value $629,823,718
Volume 721,375
Av. Daily Volume 682,685
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Upcoming Catalysts

Drug Stage Catalyst Date
Bempedoic Acid (ETC-1002) CLEAR Outcomes
Cardiovascular Diseases
Phase 3
Phase 3
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Drug Pipeline

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

Latest News

  1. – Highest Quarterly and First Half Total Revenue in Company History with $214 million in Total YTD Revenue –

    – Strong Capital Position with over $300 Million in Cash –

    – Extraordinary High-Quality Managed Care Coverage with Over 80% Commercial and Over 50% Medicare Part D Formulary Coverage –

    – Consistently High Month-Over-Month Growth for New Medicines With Acceleration in Second Half –

    – Conference Call and Webcast on August 10 at 4:30 P.M. Eastern Time –

    ANN ARBOR, Mich., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today reported financial results for the second quarter ended June 30, 2020, which included the highest quarterly and first half revenue in Company history and other updates, including the establishment of…

    – Highest Quarterly and First Half Total Revenue in Company History with $214 million in Total YTD Revenue –

    – Strong Capital Position with over $300 Million in Cash –

    – Extraordinary High-Quality Managed Care Coverage with Over 80% Commercial and Over 50% Medicare Part D Formulary Coverage –

    – Consistently High Month-Over-Month Growth for New Medicines With Acceleration in Second Half –

    – Conference Call and Webcast on August 10 at 4:30 P.M. Eastern Time –

    ANN ARBOR, Mich., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today reported financial results for the second quarter ended June 30, 2020, which included the highest quarterly and first half revenue in Company history and other updates, including the establishment of a strong commercial foundation to further accelerate the launch of NEXLETOL® (bempedoic acid) tablets and NEXLIZET (bempedoic acid and ezetimibe) tablets in the second half of 2020.

    "Esperion is in a stronger position today than ever before, fortified by the significant business achievements of our Lipid Management Team. We successfully navigated through the unprecedented environment created by the COVID-19 pandemic to launch our first two medicines, deliver on our partnerships in Japan and Europe, and strengthen our balance sheet," said Tim M. Mayleben, president and chief executive officer of Esperion. "The early feedback from U.S. healthcare providers and payers on NEXLETOL® and NEXLIZET™ has been extraordinary, reflecting strong positioning as affordable, complementary, convenient, oral, once-daily LDL-C lowering medicines and further confirmed by the broad, high-quality managed care coverage we've already secured so early in our commercial launch. While stay at home orders that were in effect across the U.S. for most of the quarter shifted the deployment of our field sales team, July prescription volumes demonstrate that all the pieces are now in place for healthcare providers and patients to access our medicines in volume."

    Recent Highlights

    Clinical and Regulatory:

    • April 2020: European Commission Marketing Approvals of NILEMDO™ (bempedoic acid) and NUSTENDI™ (bempedoic acid and ezetimibe) tablets for the treatment of hypercholesterolemia and mixed dyslipidemia.
    • July 2020: Pooled LDL-C lowering efficacy analysis from the four Phase 3 clinical studies of NEXLETOL was published in the Journal of the American Medical Association Cardiology.
    • July 2020: For the CLEAR Outcomes global cardiovascular outcomes trial (CVOT), the study has now accumulated almost 50% of events in this event-driven cardiovascular outcomes study.

    Commercial:

    • March 30, 2020: U.S. commercial availability of NEXLETOL tablets.
    • June 4, 2020: U.S. commercial availability of NEXLIZET tablets.
    • July 2020: Surpassed NEXLETOL and NEXLIZET one-year managed care coverage goals, with over 80% commercial coverage and over 50% Medicare Part D coverage with preferred brand formulary status less than four months after initial launch.

    Corporate and Business Development:

    • April 2020: Entered into a development and commercial collaboration agreement with Otsuka Pharmaceuticals Co., Ltd. (Otsuka) to develop and commercialize NEXLETOL and NEXLIZET tablets in Japan. Payments to Esperion under the agreement include $60 million upfront (received in April), up to an additional $450 million in development and sales milestones, approximately $100 million in development costs funded by Otsuka, and 15% to 30% tiered royalties on net product sales in Japan.
    • June 2020: $150 million payment received from Daiichi Sankyo Europe (DSE) upon completion of the transfer of Marketing Authorization for NUSTENDI tablets to DSE.

    Upcoming Milestones

    Fourth Quarter 2020:

    • DSE to initiate commercial rollout of NILEMDO and NUSTENDI tablets in Europe.
    • Potential Rest-of-World (ROW) development and commercial collaboration agreement.

    2020 Second Quarter Financial Results

    As of June 30, 2020, cash, cash equivalents, restricted cash and investment securities available-for-sale totaled $300.7 million compared with $201.7 million at December 31, 2019.

    Total revenue was $212.2 million for the second quarter of 2020 and $214.1 million for the six months ended June 30, 2020. This amount includes approximately $0.6 million of net product sales and $211.6 million in collaboration revenue for the second quarter of 2020 and $1.5 million and $212.6 million, respectively, for the six months ended June 30, 2020. This compares to total revenue of $1.0 million for the second quarter of 2019 and $146.4 million for the six months ended June 30, 2019. The increase in revenue was primarily related to the $60.0 million upfront payment from the collaboration with Otsuka, $150.0 million of collaboration revenue from DSE as well as net product sales of NEXLETOL and NEXLIZET.

    Research and development expenses were $35.0 million for the second quarter of 2020 and $69.7 million for the six months ended June 30, 2020, compared to $42.8 million and $89.1 million for the comparable periods in 2019. The decrease was primarily attributable to a decline in costs related to the completion of enrollment of our CLEAR CVOT, which was fully enrolled during the third quarter of 2019, and a decline in costs related to our regulatory submission activities completed in 2019.

    Selling, general and administrative expenses were $47.7 million for the second quarter of 2020 and $89.2 million for the six months ended June 30, 2020, compared to $13.5 million and $25.7 million for the comparable periods in 2019. The increase was primarily attributable to costs to support the commercialization of NEXLETOL and NEXLIZET in the U.S., increases in our headcount resulting from the buildout of our approximately 300-member customer-facing team, stock-based compensation expense, and other costs to support our growth.

    Esperion had net income of $124.6 million for the second quarter of 2020 and $46.4 million for the six months ended June 30, 2020, compared to net loss of $54.2 million and net income of $33.2 million for the comparable periods in 2019. Esperion had a basic and diluted net income per share of $4.50 and $4.32, respectively, for the second quarter of 2020 and $1.68 and $1.60, respectively, for the six months ended June 30, 2020, compared to a basic and diluted net loss per share of $2.01 and a basic and diluted net income per share of $1.23 and $1.16, respectively, for the comparable periods in 2019.

    Esperion had approximately 27.8 million shares of common stock outstanding, with another 5.1 million issuable upon exercise of stock options and vesting of restricted stock units, and $166.3 million of the revenue interest liability outstanding as of June 30, 2020.

    2020 Financial Outlook

    Esperion's cash, cash equivalents, and investments held available-for-sale as of June 30, 2020 totaled $300.7 million and expects further cash to be provided from U.S. product sales, for which Esperion is not providing guidance for in 2020, EU royalties, and upfront and/or milestone payment(s) from a potential ROW agreement for the remainder of 2020.

    Research and development expenses for the full year 2020 are expected to be $135 million to $145 million. Selling, general and administrative expenses for the full year 2020 are expected to be $200 million to $210 million. These amounts do not include $30 million in non-cash stock-based compensation.

    Esperion expects that current cash resources, coupled with revenue from NEXLETOL and NEXLIZET commercial net product sales are sufficient to fund continued operations through profitability. Any additional cash proceeds as a result from a ROW collaboration and the additional $50 million available to Esperion, at its option, under the Oberland Capital revenue-based funding agreement, are incremental to our path to profitably and further secures Esperion's sustainable cash runway.

    Conference Call and Webcast Information

    Esperion's Lipid Management Team will host a conference call and webcast on August 10, 2020 at 4:30 P.M. Eastern Time to provide a second quarter 2020 financial results and company update. The call can be accessed by dialing (877) 312-7508 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing the access code 7393523. 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 Company's 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 1,400 sites in 32 countries.

    Esperion Therapeutics

    Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. 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 the clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study, timing for the review and approval of expanded indications for their effect on cardiovascular events, and Esperion's expectations for the market for medicines to lower LDL-C, including the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, that Otsuka is able to successfully commercialize bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet, the impact of COVID-19 on our business, clinical activities and commercial development 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.





    Esperion Therapeutics, Inc.
     
    Balance Sheet Data
    (In thousands)
    (Unaudited)
        
    June 30,

    2020
     December 31,

    2019
        
    Cash and cash equivalents$298,489  $166,130 
    Working capital 237,490   145,634 
    Investments 2,247   34,651 
    Restricted cash    928 
    Total assets 330,352   214,447 
    Revenue interest liability 166,291   132,544 
    Common stock 28   27 
    Accumulated deficit (648,904)  (695,266)
    Total stockholders' equity 85,489   19,950 
        



    Esperion Therapeutics, Inc.
     
    Statement of Operations
    (In thousands, except share and per share data)
    (Unaudited)
            
     Three Months Ended

    June 30,
     Six Months Ended

    June 30,
      
      2020   2019   2020   2019
    Revenues:       
    Product sales, net$609 $  $1,467  $
    Collaboration revenue 211,627  982   212,609   146,401
    Total Revenues 212,236   982   214,076   146,401
            
    Operating expenses:       
    Cost of goods sold$398  $  $429  $
    Research and development 34,987   42,788   69,689   89,096
    Selling, general and administrative 47,681   13,492   89,234   25,674
    Total operating expenses 83,066   56,280   159,352   114,770
            
    Income (loss) from operations 129,170   (55,298)  54,724   31,631
            
    Interest expense (4,640)     (8,811)  
    Other income, net 81   1,077   449   1,527
    Net income (loss)$124,611  $(54,221) $46,362  $33,158
            
    Net income (loss) per common share - basic$4.50  $(2.01) $1.68  $1.23
    Net income (loss) per common share – diluted$4.32  $(2.01) $1.60  $1.16
            
    Weighted average shares outstanding - basic 27,665,728   26,968,818   27,592,479   26,906,149
    Weighted average shares outstanding - diluted 28,854,445   26,968,818   28,948,058   28,518,015



    Contact:

    Ben Church

    Esperion

    734-864-6774

    Primary Logo

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  2. ANN ARBOR, Mich., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced it will report second quarter 2020 financial results after the close of the U.S. financial markets on August 10, 2020. Following the release, company management will host a webcast and conference call at 4:30 p.m. ET to discuss financial results and business progress.

    Esperion Therapeutics

    Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For more information, please visit www.esperion.com

    ANN ARBOR, Mich., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced it will report second quarter 2020 financial results after the close of the U.S. financial markets on August 10, 2020. Following the release, company management will host a webcast and conference call at 4:30 p.m. ET to discuss financial results and business progress.

    Esperion Therapeutics

    Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. 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 the clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study, timing for the review and approval of expanded indications for their effect on cardiovascular events, and Esperion's expectations for the market for medicines to lower LDL-C, including the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, that Otsuka is able to successfully commercialize bempedoic acid and the bempedoic acid / ezetimibe fixed dose combination tablet,  the impact of COVID-19 on our business, clinical activities and commercial development 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

    Esperion

    734-864-6774

    Primary Logo

    View Full Article Hide Full Article
  3. ANN ARBOR, Mich., July 01, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that pooled efficacy analysis from the four Phase 3 clinical studies of NEXLETOL, an oral, once-daily LDL-cholesterol lowering medicine, was published in the Journal of the American Medical Association (JAMA) Cardiology.  The four Phase 3 clinical studies evaluated the efficacy and safety of NEXLETOL versus placebo in 3623 patients with hypercholesterolemia while receiving stable lipid-lowering therapy and at high cardiovascular risk or with hypercholesterolemia and statin intolerance.  NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH…

    ANN ARBOR, Mich., July 01, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that pooled efficacy analysis from the four Phase 3 clinical studies of NEXLETOL, an oral, once-daily LDL-cholesterol lowering medicine, was published in the Journal of the American Medical Association (JAMA) Cardiology.  The four Phase 3 clinical studies evaluated the efficacy and safety of NEXLETOL versus placebo in 3623 patients with hypercholesterolemia while receiving stable lipid-lowering therapy and at high cardiovascular risk or with hypercholesterolemia and statin intolerance.  NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL-C. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

    The publication highlighted that NEXLETOL added to maximally tolerated statins, including moderate- or high- intensity or no background statin demonstrated significant additional LDL-C lowering levels versus placebo.  In patients on background statin therapy, NEXLETOL lowered LDL-cholesterol (LDL-C) by a mean of 18 percent compared to placebo (p<0.001). In statin intolerant patients, NEXLETOL lowered LDL-C by a mean of 24 percent compared to placebo (p<0.001).  Furthermore, decreases in non-HDL-C, total cholesterol, Apo B and hsCRP were greater with NEXLETOL versus placebo.  Finally, overall and common adverse events occurred at similar rates in patients treated with NEXLETOL and placebo.

    "The body of evidence keeps growing to show that NEXLETOL has the power to alter how LDL-C lowering is handled in patients that simply aren't seeing the desired results from statins alone," said Tim Mayleben, president and chief executive officer of Esperion. "In addition, to have these data in JAMA Cardiology brings recognition to the fact that while statins help millions achieve their LDL-C goals, there is a significantly underserved patient group that truly need convenient and complementary, oral, once-daily non-statin medicines to achieve their LDL-C goals."

    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.

    Indication and Limitation of Use



    NEXLETOL 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. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

    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™ (bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL™ (bempedoic acid) tablet who had no prior gout history.
      • Tendon rupture has occurred. Discontinue NEXLETOL™ (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL™ (bempedoic acid) tablet 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.

    CLEAR Cardiovascular Outcomes Trial

    The effect of NEXLETOL or NEXLIZET 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 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.

    Esperion Therapeutics

    Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. 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 ASCVD patients who are not able to reach their LDL-C with statins alone need less than a 40 percent reduction to reach their LDL-C threshold2.

    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 the clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies for bempedoic acid tablet and the bempedoic acid / ezetimibe combination fixed dose tablet, timing for the review and approval of expanded indications for their effect on cardiovascular events, and Esperion's expectations for the market for medicines to lower LDL-C, including the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development 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.

    Investor Contact:

    Alex Schwartz

    Esperion

    734-249-3386

    Media Contact:

    Ben Church

    Esperion

    734-864-6774 

    Primary Logo

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    • Esperion to Receive $150 Million Milestone Payment in June 
    • Esperion Completes Transfer of Marketing Authorization Approvals (MAAs) for NILEMDO™ (bempedoic acid) and NUSTENDI™ (bempedoic acid and ezetimibe) Tablets to DSE     
    • DSE to Initiate Commercial Rollout of NILEMDO and NUSTENDI in Europe Starting Later this Year 

    ANN ARBOR, Mich., June 22, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced the completion of an amendment to the EU commercial collaboration agreement with Daiichi Sankyo Europe (DSE).  Earlier this month, Esperion completed the transfer to DSE of Marketing Authorization Approvals (MAA) for NILEMDO and NUSTENDI.  DSE will now pay Esperion the second $150 million milestone based on completion of the MAA transfer rather…

    • Esperion to Receive $150 Million Milestone Payment in June 
    • Esperion Completes Transfer of Marketing Authorization Approvals (MAAs) for NILEMDO™ (bempedoic acid) and NUSTENDI™ (bempedoic acid and ezetimibe) Tablets to DSE     
    • DSE to Initiate Commercial Rollout of NILEMDO and NUSTENDI in Europe Starting Later this Year 

    ANN ARBOR, Mich., June 22, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) announced the completion of an amendment to the EU commercial collaboration agreement with Daiichi Sankyo Europe (DSE).  Earlier this month, Esperion completed the transfer to DSE of Marketing Authorization Approvals (MAA) for NILEMDO and NUSTENDI.  DSE will now pay Esperion the second $150 million milestone based on completion of the MAA transfer rather than the first commercial product sale in the EU, as previously agreed.

    "Over the last eighteen months Esperion and DSE have formed a true partnership which includes the earlier-than-expected European Commission approval of NILEMDO and NUSTENDI and the acceleration of the $150 million milestone payment," said Tim M. Mayleben, president and chief executive officer of Esperion.   "Together, we are delivering on our mutual commitment to bring affordable and convenient oral, once-daily LDL-C lowering medicines to the millions of patients with elevated LDL-Cholesterol."

    The acceleration of the $150 million milestone payment from DSE was made as a result of an amendment to the License and Collaboration Agreement between the two companies, originally signed in January 2019, which also added Turkey to existing rights covering the European Economic Area and Switzerland. Previously, the milestone payment was due upon the first commercial product sale in Europe.

    Under terms of the collaboration agreement with DSE, Esperion is eligible to receive up to $900 million in total milestones as well as tiered royalties between 15% – 25%.  Upon receipt of the $150 million milestone payment later this month, Esperion will have received $300 million in total milestone payments.

    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 1,400 sites in 32 countries.

    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 the clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies for bempedoic acid tablet and the bempedoic acid / ezetimibe combination fixed dose tablet, timing for the review and approval of expanded indications for their effect on cardiovascular events, and Esperion's expectations for the market for medicines to lower LDL-C, including the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development 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.

    Investor Contact:

    Alex Schwartz

    Esperion

    734-249-3386

    Media Contact:

    Ben Church

    Esperion

    734-864-6774

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  4. ANN ARBOR, Mich., June 14, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that pooled analysis from four Phase 3 clinical studies of NEXLETOL were presented at the American Diabetes Association 80th Scientific Sessions.  According to the American Diabetes Association (ADA) guidelines, elevated LDL cholesterol is a common problem for people with diabetes. Also referred to as hyperlipidemia, this condition greatly increases the risk of developing cardiovascular disease.

    The presentation, titled "Efficacy and Safety of Bempedoic acid in Patients with Diabetes, Prediabetes, and Normoglycemia: Analysis of Pooled Patient-Level Data From 4 Phase 3 Clinical Trials" was delivered by Lawrence A. Leiter, MD, FRCPC, FACP, FACE, FAHA…

    ANN ARBOR, Mich., June 14, 2020 (GLOBE NEWSWIRE) -- Esperion (NASDAQ:ESPR) today announced that pooled analysis from four Phase 3 clinical studies of NEXLETOL were presented at the American Diabetes Association 80th Scientific Sessions.  According to the American Diabetes Association (ADA) guidelines, elevated LDL cholesterol is a common problem for people with diabetes. Also referred to as hyperlipidemia, this condition greatly increases the risk of developing cardiovascular disease.

    The presentation, titled "Efficacy and Safety of Bempedoic acid in Patients with Diabetes, Prediabetes, and Normoglycemia: Analysis of Pooled Patient-Level Data From 4 Phase 3 Clinical Trials" was delivered by Lawrence A. Leiter, MD, FRCPC, FACP, FACE, FAHA Director of the Lipid Clinic at St. Michael's Hospital and Professor of Medicine and Nutritional Sciences, University of Toronto.

    The presentation demonstrated that patients treated with NEXLETOL experienced a significant lowering of LDL-Cholesterol compared with placebo in all glycemic status subgroups.  Similarly, the analysis also showed that NEXLETOL significantly lowered total cholesterol, non-HDL-C, Apo B and hsCRP across all subgroups.  Importantly, NEXLETOL did not worsen measurements of glycemic control or increase the occurrence of new-onset diabetes compared with placebo.  In patients with diabetes (n=1,135), the analysis highlighted that NEXLETOL significantly reduced hemoglobin A1c (HbA1c) by 0.19% versus placebo at 12 weeks (p<0.001).   Finally, the safety profile of NEXLETOL was similar in patients across the glycemic status subgroups.

    "We are pleased with the pooled analysis showing NEXLETOL significantly lowered LDL-C and that this was consistent across all glycemic status subgroups as well as reduced HbA1c by 0.19% in patients with diabetes which is something we will continue to evaluate in ongoing clinical trials," said Tim Mayleben, president and chief executive officer of Esperion. "As we work toward lipid management for everybody, we now have additional useful information for these distinctive patients and their health care providers.  Importantly, this analysis adds to the growing body of information regarding the efficacy and safety of NEXLETOL for the millions of appropriate patients needing to lower their bad cholesterol."

    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. Completed Phase 3 studies conducted in more than 3,000 patients, with over 2,000 patients treated with NEXLETOL, demonstrated an average 18 percent placebo corrected LDL-C lowering when used in patients on moderate or high-intensity statins. 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.

    Indication and Limitation of Use



    NEXLETOL 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. The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.

    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™ (bempedoic acid) tablet was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLETOL™ (bempedoic acid) tablet who had no prior gout history.
      • Tendon rupture has occurred. Discontinue NEXLETOL™ (bempedoic acid) tablet at the first sign of tendon rupture. Avoid NEXLETOL™ (bempedoic acid) tablet 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.

    NEXLIZETTM (bempedoic acid and ezetimibe) Tablets

    NEXLIZET contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine. Phase 3 data demonstrated NEXLIZET lowered LDL-C by a mean of 38 percent compared to placebo when added on to maximally tolerated statins. NEXLIZET is the first non-statin, LDL-cholesterol lowering combination medicine ever approved. NEXLIZET was approved by the FDA in February 2020.

    Indication and Limitation of Use



    NEXLIZET 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. The effect of NEXLIZET on cardiovascular morbidity and mortality has not been determined.

    Important Safety Information

    • Contraindications:
      • Known hypersensitivity to ezetimibe tablets.  
    • 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 NEXLIZET was higher in patients with a prior history of gout although gout also occurred more frequently than placebo in patients treated with NEXLIZET who had no prior gout history.
      • Tendon rupture has occurred. Discontinue NEXLIZET at the first sign of tendon rupture. Avoid NEXLIZET in patients who have a history of tendon disorders or tendon rupture. 
    • Adverse Reactions:
      • The most common adverse events reported in the development program (incidence ≥ 2% and greater than placebo) were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, elevated liver enzymes, diarrhea, arthralgia, sinusitis fatigue, and influenza.  
    • Drug Interactions:
      • Simvastatin: Avoid concomitant use of NEXLIZET with simvastatin great than 20 mg
      • Pravastatin: Avoid concomitant use of NEXLIZET with pravastatin greater than 40 mg.
      • Cyclosporine: Monitor cyclosporine concentrations in patients receiving NEXLIZET and cyclosporine.
      • Fibrates: If cholelithiasis is suspected in a patient receiving NEXLIZET and fenofibrate, consider alternative lipid-lowering therapy.
    • Use in Specific Populations
      • Pregnancy: Based on mechanism of action, may cause fetal harm.
      • Lactation: Breastfeeding is not recommended with NEXLIZET.

    Click here to see the full prescribing information for NEXLIZET™ (bempedoic acid and ezetimibe) tablet.

    Patients or their physicians 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).

    CLEAR Cardiovascular Outcomes Trial

    The effect of NEXLETOL or NEXLIZET 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 14,032 patients with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.

    Esperion Therapeutics

    Through scientific and clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. 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 ASCVD patients who are not able to reach their LDL-C with statins alone need less than a 40 percent reduction to reach their LDL-C threshold2.

    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 the clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies for bempedoic acid tablet and the bempedoic acid / ezetimibe combination fixed dose tablet, timing for the review and approval of expanded indications for their effect on cardiovascular events, and Esperion's expectations for the market for medicines to lower LDL-C, including the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet in the United States and European Union. 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, delays or failures in Esperion's clinical development and commercialization plans, or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, the impact of COVID-19 on our business, clinical activities and commercial development 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.

    

    Investor Contact:

    Alex Schwartz

    Esperion

    734-249-3386

    Media Contact:

    Ben Church

    Esperion

    734-864-6774

     

    Primary Logo

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