SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): November 2, 2020
Esperion Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
|(State or other jurisdiction of|
|(Commission File Number)||(I.R.S. Employer|
3891 Ranchero Drive, Suite 150
Ann Arbor, MI
(Address of principal executive offices)
Registrant’s telephone number, including area code: (734) 887-3903
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol||Name of each exchange on which registered|
|Common Stock, par value $0.001 per share||ESPR||NASDAQ Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition
On November 2, 2020, Esperion Therapeutics, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2020 (the “Press Release”). A copy of the Press Release is furnished herewith as Exhibit 99.1.
The information set forth under Item 2.02 and in Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: November 2, 2020||Esperion Therapeutics, Inc.|
|By:||/s/ Tim M. Mayleben|
|Tim M. Mayleben|
|President and Chief Executive Officer|
ESPERION Reports Third Quarter 2020 Financial Results and Provides Company Update
–Quarter-over-quarter Script Growth Exceeded 500 Percent for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) tablets –
–U.S. Product Revenue Increased Five-fold During the Third Quarter –
–ESPERION Partner Daiichi Sankyo Europe Launches NILEMDO™ (bempedoic acid) and NUSTENDI™ (bempedoic acid and ezetimibe) in Germany, the Largest European Market –
–Conference Call and Webcast today, November 2nd at 4:30 P.M. Eastern Time –
ANN ARBOR, Mich., November 2, 2020 (GLOBE NEWSWIRE) -- ESPERION (NASDAQ:ESPR) today reported financial results for the third quarter ended September 30, 2020, and provided a business update.
“The trajectory of our U.S. launches is encouraging as quarterly script growth increased over 500 percent and product revenue trended similarly, despite persisting COVID-related headwinds. Providing increasing validation by the medical community for our medicines in the treatment of hypercholesterolemia, NEXLETOL and NEXLIZET are now included in the American Association for Clinical Endocrinologists’ updated lipid guidelines and the American Heart Journal published our CLEAR Outcomes Study design,” said Tim M. Mayleben, President and Chief Executive Officer of ESPERION. “Momentum continues to build into the fourth quarter, exemplified by our partner Daiichi Sankyo’s recent commercial launch in Germany. We believe ESPERION is well-positioned to execute on our singular focus of lipid management for everyone and drive long-term, future growth for shareholders.”
Quarterly & Recent Highlights
Clinical and Regulatory:
•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.
•August 2020: Presented two scientific posters at the European Society of Cardiology (ESC) 2020 Congress based on a pooled analysis from four Phase 3 clinical trials and long-term safety and efficacy data of NEXLETOL.
•October 2020: Professor P. Barton Duell highlighted pooled data demonstrating significant cholesterol lowering in people with familial hypercholesterolemia with NEXLETOL at the 88th Annual Congress of the European Atherosclerosis Society (EAS).
•October 2020: The American Heart Journal published the landmark CLEAR Outcomes study design spotlighting the first-of-its-kind cardiovascular outcomes trial to focus exclusively on patients with documented intolerance on statin therapy.
•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.
•September 2020: Launched “Break the Cycle with NEXLETOL” a national direct-to-consumer (DTC) campaign aimed at broadening awareness of NEXLETOL tablets.
Corporate and Business Development:
•November 2020: Daiichi Sankyo Europe (DSE) launches NUSTENDI and NILEMDO tablets in German market marking the initiation of European commercialization for our medicines.
Fourth Quarter 2020:
•Potential Rest-of-World development and commercial collaboration agreement(s).
2020 Third Quarter Financial Results
As of September 30, 2020, cash, cash equivalents, restricted cash and investment securities available-for-sale totaled $215.7 million compared with $300.7 million at June 30, 2020.
Total revenue was $3.8 million for the third quarter of 2020. This amount includes approximately $3.3 million of net product sales and $0.5 million in partner reimbursement for the third quarter of 2020. This compares to total revenue of $1.0 million for the third quarter of 2019. The increase in revenue was primarily related to U.S. net product sales of NEXLETOL and NEXLIZET.
Research and development expenses were $35.3 million for the third quarter of 2020, compared to $48.3 million for the comparable period 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.
Selling, general and administrative expenses were $48.8 million for the third quarter of 2020, compared to $18.5 million for the comparable period 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 customer-facing team, stock-based compensation expense, and other costs to support our growth.
ESPERION had net loss of $85.4 million for the third quarter of 2020, compared to net loss of $68.4 million for the comparable period in 2019. ESPERION had a basic and diluted net loss per share of $3.07, respectively, for the third quarter of 2020, compared to a basic and diluted net loss per share of $2.52 for the comparable period in 2019.
ESPERION had approximately 27.9 million shares of common stock outstanding, with another 4.9 million issuable upon exercise of stock options and vesting of restricted stock units, and $171.2 million of the revenue interest liability outstanding as of September 30, 2020.
2020 Financial Outlook
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’s cash balance as of September 30, 2020 was $215.7 million. Esperion expects that current cash resources, coupled with future revenue from NEXLETOL and NEXLIZET commercial net product sales are sufficient to fund continued operations. Cash proceeds from existing partnership collaborations, an expected ROW partnership, the additional $50 million available to Esperion, at its option, under the Oberland Capital revenue-based funding agreement, as well as potential non-dilutive funding sources 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 November 2, 2020 at 4:30 P.M. Eastern Time to provide a third quarter 2020 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 9377299.
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.
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.
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, 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, and ESPERION’s financial outlook, including expectations for future revenues from its product sales, partnership collaborations and other sources. 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 and DSE are able to successfully commercialize its products, 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.
(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
|Cash and cash equivalents||$||215,748 ||$||166,130 |
|Working capital||166,856 ||145,634 |
|Investments||— ||34,651 |
|Restricted cash||— ||928 |
|Total assets||250,969 ||214,447 |
|Revenue interest liability||171,173 ||132,544 |
|Common stock||28 ||27 |
|Total stockholders' equity||8,960 ||19,950 |
Esperion Therapeutics, Inc.
Statement of Operations
(In thousands, except share and per share data)
|||Three Months Ended|
|Nine Months Ended|
|Product sales, net||$||3,331 ||$||— ||$||4,798 ||$||— |
|Collaboration revenue||502 ||981 ||213,111 ||147,382 |
|Total Revenues||3,833 ||981 ||217,909 ||147,382 |
|Cost of goods sold||$||275 ||$||— ||$||704 ||$||— |
|Research and development||35,283 ||48,281 ||104,972 ||137,377 |
|Selling, general and administrative||48,826 ||18,468 ||138,060 ||44,142 |
|Total operating expenses||84,384 ||66,749 ||243,736 ||181,519 |
|Loss from operations||(80,551)||(65,768)||(25,827)||(34,137)|
|Other income, net||42 ||1,387 ||491 ||2,914 |
|Net loss per common share - basic and diluted||$||(3.07)||$||(2.52)||$||(1.41)||$||(1.30)|
|Weighted-average shares outstanding - basic and diluted||27,830,281 ||27,171,769 ||27,672,325 ||26,995,661 |