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): November 10, 2014

 

Esperion Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-35986

 

26-1870780

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer
Identification No.)

 

3891 Ranchero Drive, Suite 150

Ann Arbor, MI

 

48108

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s 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 November 10, 2014, Esperion Therapeutics, Inc. issued a press release announcing its financial results for the three and nine months ended September 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.

 

Description

 

 

 

99.1

 

Press Release dated November 10, 2014.

 

*      *       *

 

2



 

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: November 10, 2014

Esperion Therapeutics, Inc.

 

 

 

By:

/s/ Tim M. Mayleben

 

 

Tim M. Mayleben

 

 

President and Chief Executive Officer

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

99.1

 

Press Release dated November 10, 2014.

 

4


Exhibit 99.1

 

 

Media Contact:

Elliot Fox

W2O Group

212.257.6724

efox@w2ogroup.com

 

Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734-887-3903

mlowe@esperion.com

 

Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Third Quarter 2014 Financial Results

 

Conference Call and Webcast on Monday, November 10, 2014 at 4:30 p.m. Eastern Time

 

Ann Arbor, Mich., —(November 10, 2014)— Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical 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 third quarter ended September 30, 2014.

 

“October proved to be truly transformational for Esperion. We announced positive top-line results from our Phase 2b ETC-1002-008 clinical trial in statin intolerant and statin tolerant patients, and successfully completed a follow-on public offering raising nearly $100 million,” said Tim M. Mayleben, president and chief executive officer of Esperion. “Esperion is now positioned to advance development of ETC-1002 through a comprehensive Phase 3 program in patients with hypercholesterolemia and other cardiometabolic risk markers.”

 

Third Quarter Development Program Highlights

 

·                  In July, Esperion initiated enrollment in ETC-1002-014, a Phase 2 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 as compared with placebo for six weeks. Top-line results are expected in Q2 2015.

 

·                  On October 1st, Esperion announced positive top-line results from the ETC-1002-008, Phase 2b clinical study in patients with hypercholesterolemia with or without statin intolerance. ETC-1002 treated patients achieved LDL-cholesterol lowering of up to 30 percent as monotherapy at 12 weeks as compared to 21 percent in the ezetimibe group, and LDL-cholesterol reductions of almost 50 percent when ETC-1002 was added to ezetimibe.

 

·                  In mid-October, Esperion completed enrollment for ETC-1002-009, a Phase 2b study in 134 patients with hypercholesterolemia who already take 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. Top-line results are expected in March 2015.

 



 

Upcoming Milestones

 

·                  By early 2015, final reports from the two-year carcinogenicity studies will be submitted to the U.S. Food and Drug Administration (FDA).

·                  In March 2015, top-line results from Phase 2b of the ETC-1002-009 trial will be announced.

·                  In the second quarter of 2015, top-line results from Phase 2 of the ETC-1002-014 trial will be announced.

 

2014 Third Quarter Financial Results

 

As of September 30, 2014, cash, cash equivalents and investment securities totaled $58.0 million compared with $77.6 million at December 31, 2013. Cash, cash equivalents and investment securities at September 30, 2014, did not include the net proceeds of approximately $91.6 million from the October 2014 public offering.

 

Research and development expenses were $7.2 million for the third quarter of 2014 and $19.1 million for the nine months ended September 30, 2014, compared with $3.5 million and $8.7 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 later stages of clinical development.

 

General and administrative expenses were $2.5 million for the third quarter of 2014 and $7.7 million for the nine months ended September 30, 2014, compared with $1.9 million and $4.3 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 Esperion’s growth.

 

Net loss was $9.8 million for the third quarter of 2014 and $26.9 million for the nine months ended September 30, 2014, compared with a net loss of $5.2 million and $16.4 million for the comparable periods in 2013.

 

Esperion had approximately 15.5 million shares of common stock outstanding, with another 2.0 million to be issued upon exercise of options and warrants, and $5.0 million of debt outstanding as of September 30, 2014. Common stock outstanding at September 30, 2014, did not include 4.9 million shares issued in the October 2014 public offering.

 

2014 Financial Outlook

 

Esperion continues to expect that full-year 2014 net cash used in operating activities will be approximately $35 million, and as a result of the recent completion of a follow-on offering, it expects to end 2014 with approximately $140 million in cash, cash equivalents and investment securities on December 31, 2014. The Company estimates that current cash resources are sufficient to fund ETC-1002 through the completion of its Phase 3 development program and company operations into 2018.

 

Conference Call and Webcast Information

 

Esperion management will conduct a conference call to discuss financial and operational results for the third quarter ended September 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 27454661. 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 company’s website for two weeks.

 



 

Esperion’s 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 an emerging pharmaceutical 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, Esperion’s 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 for patients with hypercholesterolemia, including those with a history of statin intolerance. 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, and clinical development plan for, ETC-1002, the anticipated timing for reporting top-line results from Esperion’s ongoing studies, including ETC-1002-009 and ETC-1002-014 and for submitting results from its two-year nonclinical carcinogenicity studies to the FDA, and Esperion’s 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. These statements are based on management’s current expectations and accordingly are subject to uncertainty and changes in circumstances. 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 risk that positive results from a clinical study of ETC-1002 may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, or the risk that other unanticipated developments could interfere with the development (and commercialization) of ETC-1002, as well as other risks detailed in Esperion’s filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. 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)

 

 

 

September 30,

 

December 31,

 

 

 

2014

 

2013

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

40,232

 

$

56,537

 

Working capital

 

48,948

 

56,417

 

Investments

 

17,784

 

21,062

 

Total assets

 

60,530

 

78,294

 

Total debt

 

4,929

 

 

Common stock

 

15

 

15

 

Accumulated deficit

 

(94,981

)

(68,063

)

Total stockholders’ equity

 

50,223

 

74,091

 

 

Esperion Therapeutics, Inc.

 

Statement of Operations

 (In thousands, except share and per share data)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

 

2014

 

2013

 

2014

 

2013

 

 

 

(Unaudited)

 

(Unaudited)

 

(Unaudited)

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

7,174

 

$

3,483

 

$

19,102

 

$

8,676

 

General and administrative

 

2,526

 

1,924

 

7,742

 

4,347

 

Total operating expenses

 

9,700

 

5,407

 

26,844

 

13,023

 

Loss from operations

 

(9,700

)

(5,407

)

(26,844

)

(13,023

)

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(135

)

 

(136

)

(936

)

Change in fair value of warrant liability

 

 

 

 

(2,587

)

Other income, net

 

29

 

169

 

62

 

147

 

Net loss

 

$

(9,806

)

$

(5,238

)

$

(26,918

)

$

(16,399

)

Net loss per common share (basic and diluted)

 

$

(0.64

)

$

(0.34

)

$

(1.75

)

$

(3.05

)

Weighted average shares outstanding (basic and diluted)

 

15,432,641

 

15,253,704

 

15,397,745

 

5,371,335