UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 12, 2014
Esperion Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-35986 |
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26-1870780 |
(State or other jurisdiction of |
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(Commission File Number) |
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(I.R.S. Employer |
3891 Ranchero Drive, Suite 150 |
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48108 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (734) 887-3903
Not Applicable
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On August 12, 2014, Esperion Therapeutics, Inc. issued a press release announcing its financial results for the three and six months ended June 30, 2014 (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.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press Release dated August 12, 2014. |
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SIGNATURE
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: August 12, 2014 |
Esperion Therapeutics, Inc. | |
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By: |
/s/ Tim M. Mayleben |
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Tim M. Mayleben |
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President and Chief Executive Officer |
Exhibit 99.1
Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com
Investor Contact:
Jordan Kohnstam
Westwicke Partners
443.450.4189
jordan.kohnstam@westwicke.com
August 12, 2014
Esperion Therapeutics Provides ETC-1002 Development Program Update;
Reports Second Quarter 2014 Financial Results
Conference Call and Webcast on Tuesday, August 12, 2014 at 4:30 p.m. Eastern Time
Ann Arbor, Mich., (BUSINESS WIRE) Esperion Therapeutics, Inc. (NASDAQ: ESPR) a clinical-stage biopharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic risk markers, today provided ETC-1002 development program updates and financial results for the second quarter ended June 30, 2014.
Top-line results are expected in early October from our Phase 2b ETC-1002-008 clinical trial in statin intolerant patients. Results from our 2-year carcinogenicity studies are anticipated late in the fourth quarter, while top-line results from two additional Phase 2 studies are expected in the first half of 2015, said Tim M. Mayleben, president and chief executive officer of Esperion. We believe that ETC-1002 is the right drug in development for the treatment of patients with hypercholesterolemia and a history of statin intolerance. This is a patient population that is increasingly recognized as deserving of more effective oral therapy options.
Second Quarter Development Program Highlights
· In May, we completed enrollment in the Phase 2b ETC-1002-008 study in 349 patients with hypercholesterolemia with or without statin intolerance. The randomized, double-blind, parallel-group, multicenter study is evaluating parallel doses of ETC-1002 over 12 weeks as monotherapy or in combination with ezetimibe.
· Advanced patient enrollment in the Phase 2b ETC-1002-009 study in 132 patients with hypercholesterolemia already taking a statin and who are not yet at their LDL-cholesterol goal. The randomized, double-blind, parallel-group, multicenter study is evaluating parallel doses of ETC-1002 added-on to statin therapy over 12 weeks..
· In July, we initiated enrollment in the Phase 2 ETC-1002-014 study in 144 patients with hypercholesterolemia and hypertension. The randomized, double-blind, parallel group, multicenter study is evaluating 180 mg of ETC-1002 as monotherapy compared with placebo for six weeks.
· The Company held its inaugural analyst and investor day event on July 29th in New York City.
Upcoming Milestones
· In early October, report top-line results from the Phase 2b ETC-1002-008 clinical study.
· In December 2014, results from the two-year carcinogenicity studies will be submitted to FDA.
· In the first quarter of 2015, report top-line results from the Phase 2b ETC-1002-009 clinical study.
· In the second quarter of 2015, report top-line results from the Phase 2 ETC-1002-014 clinical study.
2014 Second Quarter Financial Results
As of June 30 2014, cash, cash equivalents and investment securities totaled $66.8 million compared with $77.6 million at Dec. 31, 2013.
Research and development expenses were $6.5 million for the second quarter of 2014 and $11.9 million for the six months ended June 30, 2014, compared with $3.1 million and $5.2 million for the comparable periods in 2013. The increase in research and development expenses was largely driven by the advancement of the ETC-1002 program through Phase 2 development.
General and administrative expenses were $2.7 million for the second quarter of 2014 and $5.2 million for the six months ended June 30, 2014, compared with $1.2 million and $2.4 million for the comparable periods in 2013. The increase in general and administrative expenses was largely driven by incremental expenses to support public company operations, changes in headcount including increased stock-based compensation expense and other costs to support Esperions growth.
Net loss was $9.2 million for the second quarter of 2014 and $17.1 million for the six months ended June 30, 2014, compared with a net loss of $6.9 million and $11.2 million for the comparable periods in 2013.
Esperion had approximately 15.4 million shares of common stock and $5.0 million of debt outstanding as of June 30, 2014.
2014 Financial Outlook
Esperion continues to expect that full-year 2014 net cash used in operating activities will be approximately $37 to $40 million and its cash and cash equivalents and investment securities will be approximately $42 to $45 million at Dec. 31, 2014. The Company continues to believe that existing cash resources will fund the Company into early 2016.
Conference Call and Webcast Information
Esperions management will conduct a conference call to discuss Esperions financial and operational results for the second quarter June 30, 2014 and other matters related to its future operations and performance. 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 access code 76041931. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the Esperion website at www.esperion.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the companys website for two weeks.
Esperions Commitment to Cardiometabolic Disease
Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have
uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two pre-clinical product candidates.
About Esperion Therapeutics
Esperion Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-cholesterol lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, Esperions lead product candidate, is a unique, first-in-class, orally available, once-daily small molecule designed to lower LDL-cholesterol levels and avoid the side effects associated with therapies currently available for lowering LDL-cholesterol. ETC-1002 is being developed primarily for patients with hypercholesterolemia and a history of statin intolerance. Phase 2b clinical trials for ETC-1002 are currently underway and build upon the successful and comprehensive Phase 1 and Phase 2a programs. For more information, please visit www.esperion.com and follow us on Twitter at https://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 the therapeutic potential of ETC-1002, the anticipated timing for reporting top-line results from Esperions ongoing studies, including ETC-1002-008, ETC-1002-009 and ETC-1002-014 and for submitting results from its two-year nonclinical carcinogenicity studies to the FDA, and Esperions projections for net cash used in operating activities for 2014, cash and cash equivalents and investment securities at December 31, 2014 and availability of cash resources. Any 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 Esperions actual results to differ significantly from those projected, including, without limitation, the risk that unanticipated developments could interfere with the development (and commercialization) of ETC-1002, as well as other risks detailed in Esperions filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2014. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. 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.
Esperion Therapeutics, Inc.
Balance Sheet Data
(In thousands)
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June 30, |
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December 31, |
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2014 |
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2013 |
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(Unaudited) |
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Cash and cash equivalents |
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$ |
47,944 |
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$ |
56,537 |
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Working capital |
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55,863 |
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56,417 |
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Investments |
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18,841 |
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21,063 |
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Total assets |
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69,287 |
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78,294 |
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Total debt |
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4,922 |
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Common stock |
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15 |
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15 |
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Accumulated deficit |
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(85,175 |
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(68,063 |
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Total stockholders equity |
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58,909 |
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74,091 |
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Esperion Therapeutics, Inc.
Statement of Operations
(In thousands, except share and per share data)
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Three Months Ended |
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Six Months Ended |
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2014 |
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2013 |
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2014 |
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2013 |
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(Unaudited) |
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(Unaudited) |
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(Unaudited) |
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(Unaudited) |
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Operating expenses: |
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Research and development |
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$ |
6,528 |
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$ |
3,100 |
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$ |
11,928 |
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$ |
5,193 |
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General and administrative |
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2,726 |
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1,172 |
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5,216 |
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2,423 |
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Total operating expenses |
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9,254 |
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4,272 |
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17,144 |
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7,616 |
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Loss from operations |
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(9,254 |
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(4,272 |
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(17,144 |
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(7,616 |
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Interest expense |
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(1 |
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(108 |
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(1 |
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(936 |
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Change in fair value of warrant liability |
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(2,545 |
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(2,587 |
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Other income (expense), net |
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17 |
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4 |
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33 |
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(21 |
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Net loss |
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$ |
(9,238 |
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$ |
(6,921 |
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$ |
(17,112 |
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$ |
(11,160 |
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Net loss per common share (basic and diluted) |
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$ |
(0.60 |
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$ |
(19.82 |
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$ |
(1.11 |
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$ |
(32.09 |
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Weighted average shares outstanding (basic and diluted) |
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15,399,018 |
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349,170 |
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15,385,009 |
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347,831 |
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