Esperion Therapeutics, Inc.
Esperion Therapeutics, Inc. (Form: 10-Q, Received: 08/12/2014 16:31:18)

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

Form 10-Q

 

x       QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2014

 

OR

 

o          TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                      to                

 

Commission file number: 001-35986

 

Esperion Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

26-1870780

(State or other jurisdiction of
incorporation or organization)

 

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

 

3891 Ranchero Drive, Suite 150

Ann Arbor, MI 48108

(Address of principal executive office) (Zip Code)

 

Registrant’s telephone number, including area code:

(734) 887-3903

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x   No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  x   No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer  o

 

Accelerated filer  o

 

 

 

Non-accelerated filer  x

 

Smaller reporting company  o

(Do not check if a smaller reporting company)

 

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes  o   No  x

 

As of August 1, 2014, there were 15,445,003 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.

 

 

 



Table of Contents

 

Esperion Therapeutics, Inc.

 

INDEX

 

 

 

Page

 

 

PART I — FINANCIAL INFORMATION

 

 

 

Item 1. Financial Statements

 

 

 

 

Condensed Balance Sheets at June 30, 2014 and December 31, 2013

3

 

Condensed Statements of Operations and Comprehensive Loss for the three month periods ended June 30, 2014 and 2013 and six month periods ended June 30, 2014 and 2013

4

 

Condensed Statements of Cash Flows for the six month periods ended June 30, 2014 and 2013

5

 

Notes to Condensed Financial Statements

6

 

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

14

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

22

 

 

Item 4. Controls and Procedures

22

 

 

PART II — OTHER INFORMATION

 

 

 

Item 1A. Risk Factors

23

 

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

23

 

 

Item 6. Exhibits

24

 

 

Signatures

25

 

2



Table of Contents

 

Esperion Therapeutics, Inc.

 

Condensed Balance Sheets

(in thousands, except share data)

 

 

 

June 30,
2014

 

December 31,
2013

 

 

 

(Unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

47,944

 

$

56,537

 

Short-term investments

 

11,780

 

3,525

 

Prepaid clinical development costs

 

1,330

 

196

 

Other prepaid and current assets

 

265

 

362

 

Total current assets

 

61,319

 

60,620

 

 

 

 

 

 

 

Property and equipment, net

 

851

 

81

 

Intangible assets

 

56

 

56

 

Long-term investments

 

7,061

 

17,537

 

Total assets

 

$

69,287

 

$

78,294

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

4,211

 

$

2,232

 

Accrued clinical development costs

 

360

 

884

 

Other accrued liabilities

 

885

 

1,087

 

Total current liabilities

 

5,456

 

4,203

 

 

 

 

 

 

 

Long-term debt, net of discount

 

4,922

 

 

Total liabilities

 

$

10,378

 

$

4,203

 

 

 

 

 

 

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized as of June 30, 2014 and December 31, 2013; no shares issued or outstanding at June 30, 2014 and December 31, 2013

 

 

 

Common stock, $0.001 par value; 120,000,000 shares authorized as of June 30, 2014 and December 31, 2013; 15,445,003 shares issued and 15,431,876 outstanding at June 30, 2014 and 15,357,413 shares issued and 15,340,710 outstanding at December 31, 2013

 

15

 

15

 

Additional paid-in capital

 

144,064

 

142,142

 

Accumulated other comprehensive income (loss)

 

5

 

(3

)

Accumulated deficit

 

(85,175

)

(68,063

)

Total stockholders’ equity

 

58,909

 

74,091

 

Total liabilities and stockholders’ equity

 

$

69,287

 

$

78,294

 

 

See accompanying notes to the condensed financial statements.

 

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Table of Contents

 

Esperion Therapeutics, Inc.

 

Condensed Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2014

 

2013

 

2014

 

2013

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

6,528

 

$

3,100

 

$

11,928

 

$

5,193

 

General and administrative

 

2,726

 

1,172

 

5,216

 

2,423

 

Total operating expenses

 

9,254

 

4,272

 

17,144

 

7,616

 

Loss from operations

 

(9,254

)

(4,272

)

(17,144

)

(7,616

)

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(1

)

(108

)

(1

)

(936

)

Change in fair value of warrant liability

 

 

(2,545

)

 

(2,587

)

Other income (expense), net

 

17

 

4

 

33

 

(21

)

Net loss

 

$

(9,238

)

$

(6,921

)

$

(17,112

)

$

(11,160

)

Net loss per common share (basic and diluted)

 

$

(0.60

)

$

(19.82

)

$

(1.11

)

$

(32.09

)

Weighted-average shares outstanding (basic and diluted)

 

15,399,018

 

349,170

 

15,385,009

 

347,831

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

Unrealized loss on investments

 

$

(8

)

$

 

$

(5

)

$

 

Total comprehensive loss

 

$

(9,246

)

$

(6,921

)

$

(17,117

)

$

(11,160

)

 

See accompanying notes to the condensed financial statements.

 

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Esperion Therapeutics, Inc.

 

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2014

 

2013

 

Operating activities

 

 

 

 

 

Net loss

 

$

(17,112

)

$

(11,160

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Depreciation expense

 

53

 

49

 

Amortization of debt discount and beneficial conversion feature

 

 

459

 

Amortization of debt issuance costs

 

 

18

 

Amortization of premiums and discounts on investments

 

106

 

 

Revaluation of warrants

 

 

2,587

 

Noncash interest expense on convertible notes

 

 

459

 

Stock-based compensation expense

 

1,676

 

153

 

Loss related to assets held for sale

 

29

 

29

 

(Gain)/Loss on sale of assets

 

1

 

(5

)

Changes in assets and liabilities:

 

 

 

 

 

Prepaids and other assets

 

(992

)

214

 

Accounts payable

 

1,789

 

288

 

Other accrued liabilities

 

(732

)

1,103

 

Net cash used in operating activities

 

(15,182

)

(5,806

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchases of investments

 

(4,800

)

 

Proceeds from sales/maturities of investments

 

6,926

 

 

Proceeds from sale of assets

 

12

 

56

 

Purchase of property and equipment

 

(638

)

(18

)

Net cash provided by investing activities

 

1,500

 

38

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Payments for offering costs in connection with initial public offering

 

 

(1,067

)

Proceeds from issuance of preferred stock, net of issuance costs

 

 

16,827

 

Proceeds from exercise of common stock options

 

142

 

123

 

Proceeds from warrant issuance

 

78

 

 

Proceeds from debt issuance, net of issuance costs

 

4,869

 

 

Net cash provided by financing activities

 

5,089

 

15,883

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

(8,593

)

10,115

 

Cash and cash equivalents at beginning of period

 

56,537

 

6,512

 

Cash and cash equivalents at end of period

 

$

47,944

 

$

16,627

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

Conversion of convertible promissory notes, including accrued interest of $923 into Series A preferred stock

 

$

 

$

16,623

 

Conversion of convertible long-term Pfizer note, including accrued interest of $274 into Series A-1 preferred stock

 

$

 

$

7,803

 

Deferred offering costs not yet paid

 

$

 

$

1,383

 

 

See accompanying notes to the condensed financial statements.

 

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Esperion Therapeutics, Inc.

 

Notes to the Condensed Financial Statements

(Unaudited)

 

1. The Company and Basis of Presentation

 

The Company is a clinical stage biopharmaceutical company whose planned principal operations are focused on developing and commercializing first in class, oral, low density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, the Company’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 currently available LDL-cholesterol lowering therapies. 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. The Company owns the exclusive worldwide rights to ETC-1002 and its other product candidates.  Its facilities are located in Ann Arbor and Plymouth, Michigan.

 

The Company’s primary activities since incorporation have been conducting research and development activities, including nonclinical and clinical testing, performing business and financial planning, recruiting personnel, and raising capital. Accordingly, the Company has not commenced principal operations and is subject to risks and uncertainties which include the need to research, develop, and clinically test potential therapeutic products; obtain regulatory approvals for its products and commercialize them, if approved; expand its management and scientific staff; and finance its operations with an ultimate goal of achieving profitable operations.

 

The Company has sustained operating losses since inception and expects such losses to continue over the foreseeable future. Management plans to continue to finance operations with a combination of public and private equity issuances, debt arrangements, collaborations and strategic and licensing arrangements. If adequate funds are not available, the Company may not be able to continue the development of its current or future product candidates, or to commercialize its current or future product candidates, if approved.

 

Basis of Presentation

 

The accompanying condensed financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP). In the opinion of management, the Company has made all adjustments, which include only normal recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods presented. Certain information and disclosures normally included in the annual financial statements prepared in accordance with GAAP have been condensed or omitted. These condensed interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2013 and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. The results of operations for the interim periods are not necessarily indicative of the results to be expected for a full year, any other interim periods or any future year or period.

 

Reverse Stock Split

 

On June 11, 2013, in connection with its initial public offering (the IPO), the Company effectuated a 1-for-6.986 reverse stock split of its outstanding common stock, which was approved by the Company’s board of directors on June 5, 2013. The reverse stock split resulted in an adjustment to the Series A preferred stock and Series A-1 preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion. The accompanying financial statements and notes to the financial statements give effect to the reverse stock split for all periods presented. The shares of common stock retained a par value of $0.001 per share. Accordingly, stockholders’ equity reflects the reverse stock split by reclassifying from “common stock” to “Additional paid-in capital” in an amount equal to the par value of the decreased shares resulting from the reverse stock split.

 

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Initial Public Offering

 

On July 1, 2013, the Company completed its IPO whereby the Company sold 5,000,000 shares of common stock at a price of $14.00 per share. The shares began trading on the Nasdaq Global Market on June 26, 2013. On July 11, 2013, the underwriters exercised their over-allotment option in full and purchased an additional 750,000 shares of common stock at a price of $14.00 per share. The Company received approximately $72.2 million in net proceeds from the IPO, including proceeds from the exercise of the underwriters’ over-allotment option, net of underwriting discounts and commissions and offering expenses. Upon closing of the IPO, all outstanding shares of preferred stock converted into 9,210,999 shares of common stock; and warrants exercisable for convertible preferred stock were automatically converted into warrants exercisable for 277,690 shares of common stock, resulting in the reclassification of the related convertible preferred stock warrant liability of $2.9 million to additional paid-in capital (See Note 4).

 

The following table summarizes the Company’s capitalization upon closing of its initial public offering:

 

Total common stock issued as of June 30, 2013

 

396,414

 

Conversion of Series A preferred stock into common stock upon closing of IPO

 

8,244,781

 

Conversion of Series A-1 preferred stock into common stock upon closing of IPO

 

966,218

 

Sales of common stock through IPO

 

5,000,000

 

Common stock issued as of July 1, 2013

 

14,607,413

 

Issuance of common stock to underwriters due to exercise of over-allotment

 

750,000

 

Total common stock issued as of July 11, 2013

 

15,357,413

 

 

2. Summary of Significant Accounting Policies

 

Recent Accounting Pronouncements

 

In June 2014, the Financial Accounting Standards Board issued Accounting Standards Update (ASU) 2014-10 which improves financial reporting by reducing the cost and complexity associated with the incremental reporting requirements for development stage entities without reducing the relevance of information provided to users of financial statements. Under the amended guidance, issuers are no longer required to (1) present inception-to-date information in the statements of income, cash flows, and shareholder equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage. The Company adopted the amendment which resulted in a reduction in disclosures previously relating to a development stage entity.

 

There have been no other material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013.

 

3. Debt

 

Credit Facility

 

In June 2014, the Company entered into a loan and security agreement (the “Credit Facility”) with Oxford Finance LLC which provides for initial borrowings of $5.0 million under term loans (“Term A Loan”) and additional borrowings of $15.0 million (“Term B Loan”) at the Company’s option, for a maximum of $20.0 million. On June 30, 2014, the Company received proceeds of $5.0 million from the issuance of secured promissory notes under the Term A Loan. The remaining $15.0 million available under Term B Loan becomes available to be drawn down, at the Company’s sole discretion, until March 31, 2015, upon achieving positive development results in either of the Company’s ongoing Phase 2b clinical studies (a “Milestone Event”). All secured promissory notes issued under the Credit Facility are due on July 1, 2018 and are collateralized by substantially all of the Company’s personal property, other than its intellectual property.

 

The Company is obligated to make monthly, interest-only payments on Term A Loan until July 1, 2015 and, thereafter, to pay 36 months consecutive, equal monthly installments of principal and interest from August 1, 2015 through July 1, 2018. Upon a Milestone Event, and the subsequent borrowing under the Term B Loan, the term of monthly, interest-only payments will be extended until January 1, 2016. Term A Loan bears interest at an annual rate of 6.40%. In the event the Company enters into Term B Loan, the interest rate will be the greater of (i) 6.40% or (ii) three month LIBOR rate three business days prior to the funding of the new term loan plus an additional 6.17%. In addition, a final payment equal to 8.0% of any amounts drawn under the Credit Facility is due upon the earlier of the maturity date or prepayment of the term loans. The Company is recognizing the final payment as interest expense using the effective interest method over the life of the Credit Facility.

 

There are no financial covenants associated to the Credit Facility.  However, there are negative covenants that limit or restrict the Company’s activities, which include limitations on incurring indebtedness, granting liens, mergers or acquisitions, dispositions of assets, making certain investments, entering into certain transactions with affiliates, paying dividends or distributions, encumbering or pledging interest in its intellectual property and certain other business transactions. Additionally, the Credit Facility also includes events of default, the occurrence and continuation of any of which provides the lenders the right to exercise remedies against the

 

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Company and the collateral securing the loans under the Credit Facility, which includes cash. These events of default include, among other things, non-payment of any amounts due under the Credit Facility, insolvency, the occurrence of a material adverse event, inaccuracy of representations and warranties, cross default to material indebtedness and a material judgment against the Company. Upon the occurrence of an event of default, all obligations under the Credit Facility shall accrue interest at a rate equal to the fixed annual rate plus five percentage points.

 

In connection with the borrowing of Term A Loan, the Company issued a warrant (the “Warrant”) to purchase 8,230 shares of common stock at an exercise price of $15.19 (see Note 4). The Warrant resulted in a debt discount of $0.1 million which is amortized into interest expense using the effective interest method over the life of Term A Loan. In addition, deferred financing costs of $0.1 million included in other prepaid and current assets on the consolidated balance sheet as of June 30, 2014 are amortized to interest expense using the effective-interest method over the same term. As of June 30, 2014, the remaining unamortized discount and debt issuance costs associated with the debt were $0.1 million and $0.1 million, respectively.

 

Estimated future principal payments due under the Credit Facility are as follows:

 

Years Ending December 31,

 

(in thousands)

 

2014

 

$

 

2015

 

638

 

2016

 

1,604

 

2017

 

1,709

 

2018

 

1,049

 

Total

 

$

5,000

 

 

During the six months ended June 30, 2014, the Company recognized $1,000 of interest expense related to the Credit Facility.

 

Convertible Notes

 

In January 2012, the Company issued $6.0 million of 10% convertible promissory notes to certain existing investors for cash. In September and November 2012, the Company issued the aggregate of $9.7 million of 10% convertible promissory notes that mature on September 4, 2013 for cash to certain existing investors. In connection with the September convertible note financing, the Company and the holders of the January 2012 convertible promissory notes agreed to extend the maturity date of the January 2012 notes to September 4, 2013. In February 2013, these convertible promissory notes, with an outstanding principal of $15.7 million and accrued interest of $0.9 million, were amended and then converted into 16,623,092 shares of Series A preferred stock, in accordance with their terms and at their conversion price of $1.00 per share, and following such conversion, the notes were cancelled.

 

The holders of the September convertible promissory notes received the benefit of a deemed conversion price of the September convertible promissory notes that were below the estimated fair value of the Series A convertible preferred stock at the time of their issuance. The fair value of this beneficial conversion feature was estimated to be $0.3 million. The fair value of this beneficial conversion feature was recorded to debt discount and amortized to interest expense using the effective interest method over the term of the convertible promissory notes. As a result of the conversion of the convertible promissory notes into shares of Series A preferred stock in February 2013, the Company recorded an accretion of the beneficial conversion feature of $0 and $0.2 million as interest expense during the six months ended June 30, 2014 and 2013, respectively.

 

In connection with the issuance of the September and the November 2012 convertible promissory notes, the Company issued warrants to purchase shares of Series A preferred stock for an aggregate price of $9,700. The estimated fair value of the warrants at issuance was $0.3 million. The proceeds from the sale of the preferred stock and warrants were allocated with $9.4 million to the convertible promissory notes and $0.3 million to warrants. This resulted in a discount on the convertible promissory notes which was amortized into interest expense, using the effective interest method, over the life of the convertible promissory notes (see Note 4). As a result of the conversion of the convertible promissory notes into shares of Series A preferred stock in February 2013, the Company recorded $0 and $0.2 million of interest expense for the accretion of this discount during the six months ended June 30, 2014 and 2013, respectively.

 

In April 2008, the Company acquired all of the capital stock of Esperion from Pfizer in exchange for a non-subordinated convertible note in the original principal amount of $5.0 million. This convertible promissory note had a maturity date of April 28, 2018. The note bore interest at 8.931% annually, payable semiannually on June 30 and December 31 by adding such unpaid interest to the principal of the note, which would thereafter accrue interest.

 

In May 2013 the Company entered into a stock purchase agreement with Pfizer Inc. and sold 6,750,000 shares of Series A-1 preferred stock at a price of $1.1560 per share, which was the fair value at the transaction date. The purchase price was paid through

 

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the cancellation of all outstanding indebtedness, including accrued interest, under the Pfizer convertible promissory note, which had an outstanding balance, including accrued interest, of $7.8 million as of May 29, 2013. The Series A-1 preferred stock issued in connection with this transaction was subsequently converted into 966,218 shares of common stock upon completion of the IPO on July 1, 2013.

 

4. Warrants

 

In connection with the Credit Facility entered into in June 2014, the Company issued a warrant to purchase 8,230 shares of common stock at an exercise price of $15.19. The Warrant will terminate on the earlier of June 30, 2019 and the closing of a merger or consolidation transaction in which the Company is not the surviving entity. The warrants were recorded at fair value of $0.1 million to additional-paid-in-capital in accordance with ASC 815-10 based upon the allocation of the debt proceeds. The Company estimated the fair value of the warrants using a Black-Scholes option-pricing model, which is based, in part, upon subjective assumptions including but not limited to stock price volatility, the expected life of the warrants, the risk-free interest rate and the fair value of the common stock underlying the warrants. The Company estimates the volatility of its stock based on public company peer group historical volatility that is in line with the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon bond for a maturity similar to the expected remaining life of the warrants. The expected remaining life of the warrants is assumed to be equivalent to their remaining contractual term.

 

In connection with its various convertible note financing transactions, the Company issued warrants to purchase shares of preferred stock which had provisions where the underlying issuance was contingently redeemable based on events outside the Company’s control and were recorded as a liability in accordance with ASC 480-10. The warrants were classified as liabilities and were recorded on the Company’s balance sheet at fair value on the date of issuance and marked- to-market on each subsequent reporting period, with the fair value changes recognized in the statement of operations. Subsequent to the pricing of the IPO, the Company estimated the fair values of the warrants at each reporting period using a Black-Scholes option-pricing model, which is based, in part, upon subjective assumptions including but not limited to stock price volatility, the expected life of the warrants, the risk-free interest rate and the fair value of the common stock underlying the warrants. The Company estimates the volatility of its stock based on public company peer group historical volatility that is in line with the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon bond for a maturity similar to the expected remaining life of the warrants. The expected remaining life of the warrants is assumed to be equivalent to their remaining contractual term. Prior to the pricing of the IPO, a Monte Carlo valuation model was utilized to estimate the fair value of the warrants based on the probability and timing of future financings.

 

The assumptions used in calculating the estimated fair market value at each reporting period prior to the closing of the Company’s IPO represented the Company’s best estimate, however, do involve inherent uncertainties. The estimated fair value of the warrants was determined using the Monte Carlo valuation model which totaled $0.3 million and was comprised of $0.1 million and $0.2 million as of and for the September and November 2012 financing, respectively, and was recorded as a discount on the related convertible promissory notes and amortized as interest expense over the term of the convertible promissory notes. Inherent in the Monte Carlo valuation model are assumptions related to expected stock-price volatility, expected life and risk-free interest rate. The Company estimates the volatility of its stock based on public company peer group historical volatility that is in line with the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury zero-coupon bond on the grant date for a maturity similar to the expected remaining life of the warrants. The expected life of the warrants is assumed to be equivalent to their remaining contractual term. The dividend rate is based on the historical rate, which the Company anticipates to remain at zero. The Monte Carlo model was used prior to the closing of the Company’s IPO to appropriately value the potential future exercise price based on various exit scenarios. This requires Level 3 inputs which are based on the Company’s estimates of the probability and timing of potential future financings.

 

Upon the closing of the Company’s IPO, all warrants exercisable for 1,940,000 shares of Series A preferred stock, at an exercise price of $1.00 per share, were automatically converted into warrants exercisable for 277,690 shares of common stock, at an exercise price of $6.99 per share. As a result, the Company concluded the warrants outstanding no longer met the criteria to be classified as liabilities and were reclassified to additional paid-in capital at fair value on the date of reclassification. The 277,690 warrants outstanding as of June 30, 2014 expire in February 2018.  During the three and six months ended June 30, 2014 and 2013, the Company recognized a loss of $0, $0, $2.5 million and $2.6 million, respectively, relating to the change in the fair value of the warrant liability.

 

As of June 30, 2014, the Company had warrants outstanding that were exercisable for a total of 285,920 shares of common stock at a weighted-average exercise price of $7.23 per share.

 

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5. Commitments and contingencies

 

In February 2014, the Company entered into an operating lease agreement for its principal executive offices located in Ann Arbor, Michigan commencing in April 2014 with a term of 63 months.  The Company’s lease provides for fixed monthly rent for the term of the lease, with monthly rent increasing every 12 months subsequent to the first three months of the lease, and also provides for certain rent adjustments to be paid as determined by the landlord.

 

In May 2014, the Company entered into the third amendment to the operating lease agreement for its laboratory facility in Plymouth, Michigan.  The amendment provides in part that (i) the expiration date of the term of the lease is extended from April 2014 to April 2017, (ii) the rentable laboratory space is adjusted to 3,045 square feet, (iii) the Company’s proportionate share of the landlord’s expenses and taxes is adjusted to 7.40%, (iv) the Company may exercise its option to renew the lease for one term of three years through written notice to the landlord by February 2017 and (v) the annual base rent under the lease is decreased to $37,000, subject to increase and adjustments provided in the lease.

 

The following table summarizes the Company’s future minimum lease payments as of June 30, 2014:

 

 

 

Total

 

Less than
1 Year

 

1-3 Years

 

3-5 Years

 

More than
5 Years

 

 

 

(in thousands)

 

Operating leases

 

$

615

 

$

128

 

$

267

 

$

211

 

$

9

 

Total

 

$

615

 

$

128

 

$

267

 

$

211

 

$

9

 

 

6. Investments

 

The following table summarizes the Company’s cash equivalents and investments:

 

 

 

June 30, 2014

 

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Estimated
Fair
Value

 

 

 

(in thousands)

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

357

 

$

 

$

 

$

357

 

Short-term investments:

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

237

 

 

 

237

 

U.S. treasury notes

 

9,101

 

5

 

 

9,106

 

U.S. government agency securities

 

2,437

 

 

 

2,437

 

Long-term investments:

 

 

 

 

 

 

 

 

 

U.S. treasury notes

 

1,998

 

4

 

 

2,002

 

U.S. government agency securities

 

5,063

 

 

(4

)

5,059

 

Total

 

$

19,193

 

$

9

 

$

(4

)

$

19,198

 

 

 

 

December 31, 2013

 

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Estimated
Fair
Value

 

 

 

(in thousands)

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

5,356

 

$

 

$

 

$

5,356

 

Short-term investments:

 

 

 

 

 

 

 

 

 

U.S. treasury notes

 

2,071

 

 

 

2,071

 

U.S. government agency securities

 

1,454

 

 

 

1,454

 

Long-term investments:

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

238

 

 

 

238

 

U.S. treasury notes

 

9,116

 

3

 

(2

)

9,117

 

U.S. government agency securities

 

8,187

 

1

 

(5

)

8,183

 

Total

 

$

26,422

 

$

4

 

$

(7

)

$

26,419

 

 

At June 30, 2014 and December 31, 2013, remaining contractual maturities of available for sale investments classified as current on the balance sheet were less than 12 months, and remaining contractual maturities of available for sale investments classified as long term were less than two years.

 

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There were no unrealized gains or losses on investments reclassified from accumulated other comprehensive income (loss) to other income (expense) in the Statement of Operations during the six months ended June 30, 2014 and 2013.

 

7. Fair Value Measurements

 

The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three level hierarchy:

 

Level 1 inputs:

 

Quoted prices for identical assets or liabilities in active markets;

 

 

 

Level 2 inputs:

 

Observable inputs other than Level 1 prices, such as quoted market prices for similar assets or liabilities or other inputs that are observable or can be corroborated by market data; and

 

 

 

Level 3 inputs:

 

Unobservable inputs that are supported by little or no market activity and require the reporting entity to develop assumptions that market participants would use when pricing the asset or liability.

 

The following table presents the Company’s financial assets and liabilities that have been measured at fair value on a recurring basis:

 

Description

 

Total

 

Level 1

 

Level 2

 

Level 3

 

 

 

(in thousands)

 

June 30, 2014

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

357

 

$

357

 

$

 

$

 

Available for sale securities:

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

237

 

237

 

 

 

U.S. treasury notes

 

11,108

 

11,108

 

 

 

U.S. government agency securities

 

7,496

 

 

7,496

 

 

Total assets at fair value

 

$

19,198

 

$

11,702

 

$

7,496

 

$

 

December 31, 2013

 

 

 

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

 

 

 

Money market funds

 

$

5,356

 

$

5,356

 

$

 

$

 

Available for sale securities:

 

 

 

 

 

 

 

 

 

Certificates of deposit

 

238

 

238

 

 

 

U.S. treasury notes

 

11,188

 

11,188

 

 

 

U.S. government agency securities

 

9,637

 

 

9,637

 

 

Total assets at fair value

 

$

26,419

 

$

16,782

 

$

9,637

 

$

 

 

There were no transfers between Levels 1, 2 or 3 during the six months ended June 30, 2014 and 2013.

 

Fair Value Measurements on a Nonrecurring Basis

 

In addition to items that are measured at fair value on a recurring basis, the Company also measures assets held for sale at the lower of its carrying amount or fair value on a nonrecurring basis. During the six months ended June 30, 2014 and 2013, the Company recognized impairment expense of $0 and $27,000, respectively, related to the assets held for sale. The fair value of assets held for sale was estimated using a market approach, considering the estimated fair value for other comparable equipment which are Level 3 inputs.

 

8. Convertible Preferred Stock and Stockholders’ Equity

 

On April 19, 2013, the Company issued and sold an aggregate of 17,000,000 shares of Series A preferred stock at a price of $1.00 per share for proceeds of $16.9 million, which is net of issuance costs of $0.1 million, to funds affiliated with Longitude Capital and certain existing investors. Each share of Series A preferred stock issued in the financing was convertible into 0.143 shares of common stock as of June 30, 2013.  Upon the closing of the financing, Patrick Enright of Longitude Capital became a member of the board of directors.

 

On May 29, 2013, the Company entered into a stock purchase agreement with Pfizer Inc. and issued and sold 6,750,000 shares of Series A-1 preferred stock at a price of $1.1560 per share. The purchase price was paid through the cancellation of all

 

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outstanding indebtedness, including accrued interest, under the Pfizer convertible promissory note, which had an aggregate balance, including accrued interest, of $7.8 million as of May 29, 2013. Each share of Series A-1 preferred stock issued in the agreement was convertible into 0.143 shares of common stock upon the closing of the Company’s IPO.

 

Upon the closing of the Company’s IPO on July 1, 2013, all of the outstanding shares of convertible preferred stock were converted into 9,210,999 shares of common stock. As of June 30, 2014, the Company did not have any convertible preferred stock issued or outstanding.

 

9. Stock Compensation

 

2013 Stock Option and Incentive Plan

 

On June 7, 2013, the Company’s stockholders approved the 2013 Stock Option and Incentive Plan (the “2013 Plan”), which became effective on June 25, 2013. The number of shares of stock reserved and available for issuance under the 2013 Plan is the sum of (i) 1,100,000, plus (ii) 54,129 shares originally reserved under the Company’s 2008 Incentive Stock Option and Restricted Stock Plan (the “2008 Plan”) that became available for issuance under the 2013 Plan upon completion of the Company’s initial public offering, plus (iii) the shares underlying any awards granted under the 2008 Plan that are forfeited, canceled, held back upon the exercise of an option or settlement of an award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of stock or otherwise terminated (other than be exercise).  Additionally, on January 1, 2014 and each January 1 thereafter, the number of shares reserved and available for issuance under the 2013 Plan shall be cumulatively increased by two and a half percent of the number of shares issued and outstanding on the immediately preceding December 31 or such lesser number of shares as determined by the plan administrator. On January 1, 2014, the number of shares of stock reserved and available for issuance under the 2013 Plan increased by 383,935 shares.

 

Under the 2013 Plan the vesting of options granted or restricted awards given will be determined individually with each option grant. Stock options have a 10 year life and expire if not exercised within that period, or if not exercised within 90 days of cessation of employment with the Company.

 

The following table summarizes the activity relating to the Company’s options to purchase common stock for the six months ended June 30, 2014:

 

 

 

Number of
Options

 

Weighted-Average
Price
Per Share

 

Weighted-Average
Remaining
Contractual
Term (Years)

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in thousands)

 

Outstanding at December 31, 2013

 

1,401,101

 

$

9.59

 

8.95

 

$

7,755

 

Granted

 

251,500

 

$

14.67

 

 

 

 

 

Forfeited or expired (vested and unvested)

 

(38,771

)

$

6.17

 

 

 

 

 

Exercised

 

(87,590

)

$

1.62

 

 

 

 

 

Outstanding at June 30, 2014

 

1,526,240

 

$

10.98

 

8.69

 

$

8,150

 

 

The following table summarizes information about the Company’s stock option plan as of June 30, 2014:

 

 

 

Number of
Options

 

Weighted-Average
Price
Per Share

 

Weighted-Average
Remaining
Contractual
Term (Years)

 

Aggregate
Intrinsic
Value

 

 

 

 

 

 

 

 

 

(in thousands)

 

Vested and expected to vest at June 30, 2014

 

1,465,510

 

$

10.90

 

8.67

 

$

7,928

 

Exercisable at June 30, 2014

 

609,994

 

$

4.59

 

7.78

 

$

6,956

 

 

As of June 30, 2014, there was approximately $8.4 million of unrecognized compensation cost related to unvested options, adjusted for forfeitures, which will be recognized over a weighted-average period of approximately 3 years.

 

10. Income Taxes

 

There was no provision for income taxes for the three or six months ended June 30, 2014 and 2013 because the Company has incurred operating losses since inception. At June 30, 2014, the Company has concluded that it is more likely than not that the Company will not realize the benefit of its deferred tax assets due to its history of losses. Accordingly, the net deferred tax assets have been fully reserved.

 

11. Net Loss Per Common Share

 

Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing net loss by

 

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the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, warrants for common stock, stock options and unvested restricted stock are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. Interest expense for convertible debt that is dilutive is added back to net income in the calculation of diluted net loss per share.

 

The shares outstanding at the end of the respective periods presented below, after giving effect for the 1-for-6.986 reverse stock split, were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

 

 

 

June 30,
2014

 

December 31,
2013

 

 

 

 

 

 

 

Warrants for common stock

 

285,920

 

277,690

 

Common shares under option

 

1,526,240

 

1,401,101

 

Unvested restricted stock

 

13,127

 

16,703

 

Total potential dilutive shares

 

1,825,287

 

1,695,494

 

 

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Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our annual report on Form 10-K dated December 31, 2013.

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act). These forward-looking statements are based on our management’s belief and assumptions and on information currently available to management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events, including our clinical development plans, or our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements, including in relation to the clinical development of ETC-1002, to be materially different from any future results, performance or achievements, including in relation to the clinical development of ETC-1002, expressed or implied by these forward-looking statements.

 

Forward -looking statements are often identified by the use of words such as , but not limited to, “ may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other similar terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which are, in some cases, beyond our control and that could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those referred to or discussed in the section titled “Risk Factors” included in Item 1A of Part II of this Quarterly Report on Form 10-Q . If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance.

 

The forward-looking statements in this report represent our views as of the date of this quarterly report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

 

Overview

 

Corporate Overview

 

We are 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 patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, our 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 currently available LDL-cholesterol lowering therapies. 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. We hold the exclusive worldwide rights to ETC-1002 and our other product candidates.

 

We were incorporated in Delaware in January 2008 and commenced our operations in April 2008. Since our inception, we have devoted substantially all of our resources to developing ETC-1002 and our other product candidates, business planning, raising capital and providing general and administrative support for these operations. We have funded our operations primarily through the issuance of preferred stock, our initial public offering of common stock, which we closed in July 2013, convertible promissory notes, secured promissory notes, and warrants to purchase shares of preferred stock.

 

On July 1, 2013, we completed the initial public offering, or IPO, of our common stock pursuant to a registration statement on Form S-1. In the IPO, we sold an aggregate of 5,000,000 shares of common stock under the registration statement at a public offering price of $14.00 per share. Net proceeds from the IPO were approximately $62.7 million, after deducting underwriting discounts and commissions and offering expenses. Upon the closing of the IPO, all outstanding shares of our preferred stock were converted into 9,210,999 shares of common stock. Additionally, as part of the IPO, we granted the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock at the IPO price to cover over-allotments, if any. On July 11, 2013, the underwriters exercised this option in full. As a result of this exercise, we received an additional $9.5 million in proceeds, net of underwriting discounts and commissions and offering expenses.

 

We have not commenced principal operations and do not have any products approved for sale. To date, we have not generated any revenue. We have never been profitable and our net losses were $9.2 million and $6.9 million for the three months ended June 30, 2014 and 2013, and were $17.1 million and $11.2 million for the six months ended June 30, 2014 and 2013, respectively. Substantially all of our net losses resulted from costs incurred in connection with research and development programs, general and administrative costs associated with our operations and the mark-to-market of our liability classified warrants. We expect to incur significant expenses and increasing operating losses for the foreseeable future. We expect our expenses to increase in connection with our ongoing activities, including, among others:

 

·         conducting additional clinical studies of ETC-1002 to complete its development;

 

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·         seeking regulatory approval for ETC-1002;

 

·         commercializing ETC-1002; and

 

·         operating as a public company.

 

Accordingly, we will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity or debt financings or through other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a material adverse effect on our financial condition and our ability to pursue our business strategy or continue operations. We will need to generate significant revenues to achieve profitability, and we may never do so.

 

Product Overview

 

ETC-1002, our lead product candidate, is a novel, first in class, orally available, once-daily small molecule therapy designed to target known lipid and carbohydrate metabolic pathways to lower levels of LDL-cholesterol and to avoid side effects associated with currently available LDL-cholesterol lowering therapies to improve cardiometabolic risk markers. We acquired the rights to ETC-1002 from Pfizer in 2008. We own the exclusive worldwide rights to ETC-1002 and we are not obligated to make any royalty or milestone payments to Pfizer.

 

During the six months ended June 30, 2013, we incurred $4.3 million in expenses related to our Phase 2a proof-of-concept clinical study in patients with hypercholesterolemia and Type 2 diabetes (ETC-1002-005) which reported top-line results in January 2013, our Phase 2a proof-of-concept clinical study in patients with hypercholesterolemia and a history of statin intolerance (ETC-1002-006) which reported top-line results in June 2013 and our Phase 2a clinical study in patients with hypercholesterolemia already taking atorvastatin 10 mg (ETC-1002-007) which reported top-line results in September 2013.

 

During the six months ended June 30, 2014, we incurred $7.5 million in expenses related to our Phase 2b clinical study in patients with hypercholesterolemia with or without statin intolerance (ETC-1002-008), our Phase 2b clinical study in patients with hypercholesterolemia already receiving statin therapy (ETC-1002-009), our Phase 2 clinical study in patients with hypercholesterolemia and hypertension (ETC-1002-014) and other clinical pharmacology studies (ETC-1002-012 and ETC-1002-013).

 

We also have two other product candidates in preclinical development. We licensed one of these product candidates from the Cleveland Clinic Foundation, or CCF, and are obligated to make certain royalty and milestone payments (consisting of cash and common stock) to CCF, including a minimum annual cash payment of $50,000 during years when a milestone payment is not met. No milestone or royalty payments will be due to any third-party in connection with the development and commercialization of our other preclinical product candidate, ESP41091.

 

Program Developments

 

ETC-1002-008 — Phase 2b clinical study in patients with hypercholesterolemia with or without statin intolerance

 

The ETC-1002-008 Phase 2b clinical study randomized 349 patients at 62 sites across the U.S. and is evaluating parallel doses of 120 mg or 180 mg of ETC-1002 as monotherapy or in combination with ezetimibe.  The primary objective of this study is to assess the LDL-cholesterol lowering efficacy of ETC-1002 monotherapy versus ezetimibe monotherapy in patients with hypercholesterolemia with or without statin intolerance treated for 12 weeks.  Secondary objectives include assessing the dose response of ETC-1002, assessing the effect of ETC-1002 on additional lipid and cardiometabolic biomarkers including hsCRP (high sensitivity C-reactive protein), characterizing the tolerability and safety of ETC-1002 and assessing the safety and efficacy of ETC-1002 in combination with ezetimibe.  We initiated ETC-1002-008 in October 2013 and expect to report top-line results from this study in October 2014.

 

ETC-1002-009 — Phase 2b clinical study in patients with hypercholesterolemia already receiving statin therapy

 

The ETC-1002-009 Phase 2b clinical study is a randomized, double-blind, placebo-controlled study that is evaluating parallel doses of 120 mg or 180 mg of ETC-1002 versus placebo for 12 weeks in approximately 132 patients with hypercholesterolemia who are already receiving statin therapy.  The primary objective of the study is to assess the LDL-cholesterol lowering efficacy of ETC-1002 in patients with hypercholesterolemia already receiving statin therapy.  Secondary objectives include assessing the dose response of ETC-1002, assessing the effect of ETC-1002 on additional lipid and cardiometabolic risk markers including hsCRP and characterizing the tolerability and safety of ETC-1002.  We initiated ETC-1002-009 in March 2014 and expect to report top-line results from this study in the first quarter of 2015.

 

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ETC-1002-014 — Phase 2 clinical study in patients with hypercholesterolemia and hypertension

 

The ETC-1002-014 Phase 2 clinical trial is a randomized, double-blind, multi-center, placebo-controlled study that is evaluating parallel doses of 120 mg or 180 mg of ETC-1002 versus placebo for six weeks in approximately 144 patients with both hypercholesterolemia and hypertension. The primary objective of the study is to assess the LDL-cholesterol lowering efficacy of ETC-1002 monotherapy versus placebo and secondary objectives include assessing the effect of ETC-1002 on blood pressure, other lipid and cardiometabolic risk markers and characterizing the tolerability and safety of ETC-1002.  We initiated ETC-1002-014 in July 2014 and expect to report top-line results from this study in the second quarter of 2015.

 

ETC-1002 Nonclinical Studies

 

In the second quarter of 2014, we submitted final reports for the long term, chronic safety studies in monkeys (12 months) and rats (6 months) to FDA.  There were no unexpected findings in these studies. The two-year carcinogenicity studies in mice and rats were completed in the second quarter of 2014 and we expect final results and reports from these studies to be filed with FDA in December 2014.

 

Financial Operations Overview

 

Revenue

 

To date, we have not generated any revenue. In the future, we may generate revenue from the sale of ETC-1002 or our other product candidates. If we fail to complete the development of ETC-1002 or our other product candidates and secure approval from regulatory authorities, our ability to generate future revenue and our results of operations and financial position will be adversely affected.

 

Research and Development Expenses

 

Since our inception, we have focused our resources on our research and development activities, including conducting preclinical and clinical studies. Our research and development expenses consist primarily of costs incurred in connection with the development of ETC-1002, which include:

 

·         expenses incurred under agreements with consultants, contract research organizations, or CROs, and investigative sites that conduct our preclinical and clinical studies;

 

·         the cost of acquiring, developing and manufacturing clinical study materials;

 

·         employee-related expenses, including salaries, benefits, stock-based compensation and travel expenses;

 

·         allocated expenses for rent and maintenance of facilities, insurance and other supplies; and

 

·         costs related to compliance with regulatory requirements.

 

We expense research and development costs as incurred. To date, substantially all of our research and development work has been related to ETC-1002. Costs for certain development activities, such as clinical studies, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors. Our direct research and development expenses consist principally of external costs, such as fees paid to investigators, consultants, central laboratories and CROs in connection with our clinical studies. We do not allocate acquiring and manufacturing clinical study materials, salaries, stock-based compensation, employee benefits or other indirect costs related to our research and development function to specific programs.

 

Our research and development expenses are expected to increase in the foreseeable future. Costs associated with ETC-1002 will increase as we continue to conduct our Phase 2b clinical studies and initiate our Phase 3 clinical studies. We cannot determine with certainty the duration and completion costs associated with the ongoing or future clinical studies of ETC-1002. Also, we cannot conclude with certainty if, or when, we will generate revenue from the commercialization and sale of ETC-1002 or our other product candidates for which we obtain regulatory approval, if ever. We may never succeed in obtaining regulatory approval for any of our product candidates, including ETC-1002. The duration, costs and timing associated with the development and commercialization of ETC-1002 and our other product candidates will depend on a variety of factors, including uncertainties associated with the results of our clinical studies and our ability to obtain regulatory approval. For example, if the FDA or another regulatory authority were to require us to conduct clinical studies beyond those that we currently anticipate will be required for the completion of clinical development or post-commercialization clinical studies of ETC-1002, or if we experience significant delays in enrollment in any of

 

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our clinical studies, we could be required to expend significant additional financial resources and time on the completion of clinical development or post-commercialization clinical studies of ETC-1002.

 

General and Administrative Expenses

 

General and administrative expenses primarily consist of salaries and related costs for personnel, including stock-based compensation and travel expenses, associated with our executive, accounting and finance, operational and other administrative functions. Other general and administrative expenses include facility related costs, communication expenses and professional fees for legal, patent prosecution, protection and review, consulting and accounting services.

 

We anticipate that our general and administrative expenses will increase in the future in connection with the continued research and development and commercialization of ETC-1002, increases in our headcount, expansion of our information technology infrastructure, increased legal, compliance, accounting and investor and public relations expenses associated with being a public company.

 

Interest Expense

 

Interest expense consists primarily of non-cash interest costs associated with our convertible promissory notes, cash interest costs associated with our Credit Facility and non-cash interest costs associated to the amortization of the related debt discount, deferred issuance costs and final payment fee.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in our financial statements. We evaluate our estimates and judgments on an ongoing basis, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events, contractual milestones and other various factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions.

 

In June 2014, the Financial Accounting Standards Board issued Accounting Standards Update (ASU) 2014-10 which improves financial reporting by reducing the cost and complexity associated with the incremental reporting requirements for development stage entities without reducing the relevance of information provided to users of financial statements. Under the amended guidance, we are no longer required to (1) present inception-to-date information in the statements of income, cash flows, and shareholder equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage. We adopted the amendment which resulted in a reduction in disclosures previously relating to a development stage entity.

 

With the exception of the Company’s adoption of the accounting standard noted above, there have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2013.

 

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Results of Operations

 

Comparison of the Three Months Ended June 30, 2014 and 2013

 

The following table summarizes our results of operations for the three months ended June 30, 2014 and 2013:

 

 

 

Three Months Ended June 30,

 

 

 

 

 

2014

 

2013

 

Change

 

 

 

(Unaudited, in thousands)

 

Operating Expenses:

 

 

 

 

 

 

 

Research and development

 

$

6,528

 

$

3,100

 

$

3,428

 

General and administrative

 

2,726

 

1,172

 

1,554

 

Loss from operations

 

(9,254

)

(4,272

)

(4,982

)

Interest expense

 

(1

)

(108

)

107

 

Change in fair value of warrant liability

 

 

(2,545

)

2,545

 

Other income (expense), net

 

17

 

4

 

13

 

Net loss

 

$

(9,238

)

$

(6,921

)

$

(2,317

)

 

Research and development expenses

 

Research and development expenses for the three months ended June 30, 2014 were $6.5 million, compared to $3.1 million for the three months ended June 30, 2013, an increase of $3.4 million. The increase in research and development expenses is primarily related to the further clinical development of ETC-1002 in our Phase 2 clinical program.

 

General and administrative expenses

 

General and administrative expenses for the three months ended June 30, 2014 were $2.7 million, compared to $1.2 million for the three months ended June 30, 2013, an increase of $1.5 million. The increase in general and administrative expenses was primarily attributable to costs to support public company operations, increases in our headcount, which includes increased stock-based compensation expense, and other costs to support our growing organization.

 

Interest expense

 

We incurred $1,000 in interest expense for the three months ended June 30, 2014 compared to $0.1 million for the three months ended June 30, 2013. The decrease in interest expense was primarily related the conversion of our convertible promissory notes issued in January, September and November 2012, into an aggregate of 16,623,092 shares of Series A preferred stock in February 2013, as well as the elimination of accrued interest on the 8.931% convertible promissory note issued to Pfizer, which converted into 6,750,000 shares of Series A-1 preferred stock in May 2013. This was partially offset by interest expense related to our Credit Facility during the three months ended June 30, 2014.

 

Change in fair value of warrant liability

 

The outstanding warrants at June 30, 2013 to purchase 277,690 shares of our common stock required liability classification and mark-to-market accounting at each reporting period in accordance with ASC 480-10 prior to the completion of our IPO. The fair values of the warrants were determined using the Monte Carlo simulation valuation model and resulted in the recognition of a loss of $2.5 million related to the change in fair values for the three months ended June 30, 2013.

 

Other income (expense), net

 

Other income (expense), net for the three months ended June 30, 2014 was income of $17,000 compared to $4,000 for the three months ended June 30, 2013, an increase of $13,000. This increase was primarily related to an increase in interest income earned on our cash and cash equivalents.

 

Comparison of the Six Months Ended June 30, 2014 and 2013

 

The following table summarizes our results of operations for the six months ended June 30, 2014 and 2013:

 

 

 

Six Months Ended June 30,

 

 

 

 

 

2014

 

2013

 

Change

 

 

 

(Unaudited, in thousands)

 

Operating Expenses:

 

 

 

 

 

 

 

Research and development

 

$

11,928

 

$

5,193

 

$

6,735

 

General and administrative

 

5,216

 

2,423

 

2,793

 

Loss from operations

 

(17,144

)

(7,616

)

(9,528

)

Interest expense

 

(1

)

(936

)

935

 

Change in fair value of warrant liability

 

 

(2,587

)

2,587

 

Other income (expense), net

 

33

 

(21

)

54

 

Net loss

 

$

(17,112

)

$

(11,160

)

$

(5,952

)

 

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Research and development expenses

 

Research and development expenses for the six months ended June 30, 2014 were $11.9 million, compared to $5.2 million for the six months ended June 30, 2013, an increase of $6.7 million. The increase in research and development expenses is primarily related to the further clinical development of ETC-1002 in our Phase 2 clinical program.

 

General and administrative expenses

 

General and administrative expenses for the six months ended June 30, 2014 were $5.2 million, compared to $2.4 million for the six months ended June 30, 2013, an increase of $2.8 million. The increase in general and administrative expenses was primarily attributable to costs to support public company operations, increases in our headcount, which includes increased stock-based compensation expense, and other costs to support our growing organization.

 

Interest expense

 

We incurred $1,000 in interest expense for the six months ended June 30, 2014 compared to $0.9 million for the six months ended June 30, 2013. The decrease in interest expense was primarily related the conversion of our convertible promissory notes issued in January, September and November 2012, into an aggregate of 16,623,092 shares of Series A preferred stock in February 2013, as well as the elimination of accrued interest on the 8.931% convertible promissory note issued to Pfizer, which converted into 6,750,000 shares of Series A-1 preferred stock in May 2013. This was offset by interest expense related to our Credit Facility during the six months ended June 30, 2014.

 

Change in fair value of warrant liability

 

The outstanding warrants at June 30, 2013, to purchase 277,690 shares of our common stock required liability classification and mark-to-market accounting at each reporting period in accordance with ASC 480-10 prior to the completion of our IPO. The fair values of the warrants were determined using the Monte Carlo simulation valuation model and resulted in the recognition of a loss of $2.6 million related to the change in fair values for the six months ended June 30, 2013.

 

Other income (expense), net

 

Other income (expense), net for the six months ended June 30, 2014 was income of $33,000 compared to expense of $21,000 for the six months ended June 30, 2013, a $54,000 increase in income. This increase was primarily related to an increase in interest income earned on our cash and cash equivalents and a decrease in impairment charges on our assets held for sale.

 

Liquidity and Capital Resources

 

We have funded our operations since inception through the sale of common stock in our IPO, private placements of preferred stock, convertible promissory notes, secured promissory notes, and warrants to purchase shares of preferred stock. To date, we have not generated any revenue, and we anticipate that we will continue to incur losses for the foreseeable future.

 

In July 2013, we completed our IPO pursuant to a registration statement on Form S-1. In the IPO, we issued and sold an aggregate of 5,750,000 shares of common stock, including the underwriters’ exercise in full of their over-allotment option, under the registration statement at a public offering price of $14.00 per share. Net proceeds were approximately $72.2 million, after deducting underwriting discounts and commissions and offering expenses.

 

In June 2014, we entered into a Credit Facility, which provides for initial borrowings of $5.0 million and additional borrowings of $15.0 million. We received proceeds of $4.9 million, net of issuance costs, from the issuance of secured promissory notes under a term loan as part of the facility. The remaining $15.0 million is available to us, at our sole discretion, until March 31, 2015, subject to achieving positive development results in either of the our ongoing Phase 2b clinical studies. All secured promissory notes issued under the Credit Facility are due on July 1, 2018 and are collateralized by substantially all of our personal property, other than our intellectual property. There are no financial covenants associated to the Credit Facility.  However, there are negative covenants that limit or restrict our activities, which include limitations on incurring indebtedness, granting liens, mergers or acquisitions, dispositions

 

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of assets, making certain investments, entering into certain transactions with affiliates, paying dividends or distributions, encumbering or pledging interest its intellectual property and other certain business transactions.

 

Under the Credit Facility, we are obligated to make monthly, interest-only payments on any term loans funded until July 1, 2015 and, thereafter, to pay 36 months consecutive, equal monthly installments of principal and interest from August 1, 2015 through July 1, 2018. Upon subsequent borrowings under the Credit Facility, the term of monthly, interest-only payments will be extended until January 1, 2016. Term loans outstanding under the Credit Facility bear interest at an annual rate of 6.40%. In addition, a final payment equal to 8.0% of any amounts drawn under the Credit Facility is due upon the earlier of the maturity date or prepayment of the term loans.

 

As of June 30, 2014, our primary sources of liquidity were our cash and cash equivalents and available-for-sale investments, which totaled $47.9 million and $18.8 million, respectively. We invest our cash equivalents and investments in highly liquid, interest-bearing investment-grade and government securities to preserve principal.

 

The following table summarizes the primary sources and uses of cash for the periods presented below:

 

 

 

Six Months Ended June 30,

 

 

 

2014

 

2013

 

 

 

(in thousands)

Cash used in operating activities

 

$

(15,182

)

$

(5,806

)

Cash provided by investing activities

 

1,500

 

38

 

Cash provided by financing activities

 

5,089

 

15,883

 

Net increase (decrease) in cash and cash equivalents

 

$

(8,593

)

$

10,115

 

 

Operating Activities

 

We have incurred, and expect to continue to incur, significant costs in the areas of research and development, regulatory and other clinical study costs, associated with our development of ETC-1002.

 

Net cash used in operating activities totaled $15.2 million and $5.8 million for the six months ended June 30, 2014 and 2013, respectively. The primary use of our cash was to fund the development of ETC-1002, adjusted for non-cash expenses, such as depreciation and amortization, stock-based compensation expense, revaluation of warrant liabilities and changes in working capital.

 

Investing Activities

 

Net cash provided by investing activities of $1.5 million for the six months ended June 30, 2014 consisted primarily of proceeds from the sales of highly liquid, interest bearing investment-grade and government securities, partially offset by purchases of such securities and purchases of property and equipment.

 

Financing Activities

 

Net cash provided by financing activities of $5.1 million for the six months ended June 30, 2014 related primarily to proceeds from our Credit Facility and exercise of stock options.

 

Plan of Operations and Funding Requirements

 

ETC-1002 is currently in Phase 2b clinical development, and we expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We expect that our existing cash and cash equivalents and available-for-sale investments will enable us to fund our operating expenses and capital expenditure requirements through at least the end of 2015 and that we will likely need to raise additional capital thereafter to continue to fund the further development of ETC-1002 and our operations. We expect to announce top-line results from our Phase 2b ETC-1002-008 and Phase 2b ETC-1002-009 clinical studies in October 2014 and the first quarter of 2015, respectively, and to have an end-of-Phase 2 meeting with the FDA in the second quarter of 2015. We have based these estimates on assumptions that may prove to be wrong, and we may use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of ETC-1002, and the extent to which we may enter into collaborations with pharmaceutical partners regarding the development and commercialization of ETC-1002, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development and commercialization of ETC-1002. Our future funding requirements will depend on many factors, including, but not limited to:

 

·         our ability to successfully develop and commercialize ETC-1002 and our other product candidates;

 

·         the costs, timing and outcomes of our ongoing and planned clinical studies of ETC-1002;

 

·         the time and cost necessary to obtain regulatory approvals for ETC-1002, if at all;

 

·         our ability to establish a sales, marketing and distribution infrastructure to commercialize ETC-1002 in the United States and abroad or our ability to establish any future collaboration or commercialization arrangements on favorable terms, if at all;

 

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·         the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and

 

·         the implementation of operational and financial information technology.

 

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams or ETC-1002 or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or through collaborations, strategic alliances or licensing arrangements when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market ETC-1002 that we would otherwise prefer to develop and market ourselves.

 

Contractual Obligations and Commitments

 

We were originally party to a single lease that covered both office and laboratory space in Plymouth, Michigan. The Plymouth lease, as amended over time, was scheduled to expire in April 2014. In February 2014, we signed a new lease to move our principal executive offices to Ann Arbor, Michigan, while still maintaining our laboratory space in Plymouth. The Ann Arbor lease has a term of 63 months and provides for fixed monthly rent of approximately $7,900, with monthly rent increasing every 12 months, and also provides for certain rent adjustments to be paid as determined by the landlord. In May 2014, we amended the Plymouth lease to (i) extend the expiration date from April 2014 to April 2017, (ii) adjust the rentable space to 3,045 square feet, (iii) adjust our proportionate share of the landlord’s expenses and taxes to 7.40%, (iv) extend our option to renew for one term of three years through written notice to the landlord by February 2017 and (v) decrease the annual base rent to $37,000, subject to certain increase and adjustments.

 

We are also party to a license agreement pursuant to which we are obligated to make future minimum annual payments of $50,000 in years during which milestone payments are not triggered under the agreement. In addition, we are also contractually obligated to issue up to an aggregate of 11,451 shares of common stock upon various milestones set forth in the agreement.

 

The following table summarizes our future minimum contractual obligations as of June 30, 2014:

 

 

 

Total

 

Less than
1 Year

 

1-3 Years

 

3-5 Years

 

More than
5 Years

 

 

 

(in thousands)

 

Operating leases

 

$

615

 

$

128

 

$

267

 

$

211

 

$

9

 

Debt commitments (1)

 

6,229

 

294

 

3,546

 

2,389

 

 

Total

 

$

6,844

 

$

422

 

$

3,813

 

$

2,600

 

$

9

 

 


(1)                                      We entered into a credit facility agreement in June 2014. The amounts in this table reflect the contractually required principal and interest payments in accordance with the payment schedule.

 

There have been no material changes to our contractual obligations and commitments outside the ordinary course of business from those disclosed above.

 

Off-Balance Sheet Arrangements

 

We do not currently have, nor did we have during the periods presented, any off-balance sheet arrangements as defined by Securities and Exchange Commission rules.

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

We had cash and cash equivalents and available-for-sale investments of approximately $47.9 million and $18.8 million at June 30, 2014 and $56.5 million and $21.1 million at December 31, 2013, respectively. The primary objectives of our investment activities are to preserve principal, provide liquidity and maximize income without significantly increasing risk. Our primary exposure to market risk relates to fluctuations in interest rates which are affected by changes in the general level of U.S. interest rates. Given the short-term nature of our cash equivalents, we believe that a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation. We do not have any foreign currency or other derivative financial instruments.

 

The amounts outstanding under our Credit Facility are fixed at an annual interest rate of 6.40%. The Credit Facility entered into in June 2014, allows for additional borrowings in the form of an additional term loan. In the event we enter into the additional term loan, the interest rate will be the greater of (i) 6.40% or (ii) three month LIBOR rate three business days prior to the funding of the new term loan plus an additional 6.17%. In the event we make additional borrowings under the Credit Facility, changes in LIBOR interest rates may increase the interest rates we would pay on such term loans and increase our cost of capital which may have a significant impact to our financial condition.

 

We do not believe that our cash, cash equivalents and available-for-sale investments have significant risk of default or illiquidity. While we believe our cash and cash equivalents do not contain excessive risk, we cannot provide absolute assurance that in the future our investments will not be subject to adverse changes in market value. In addition, we maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.

 

Inflation generally affects us by increasing our cost of labor and clinical study costs. We do not believe that inflation has had a material effect on our results of operations during the three or six months ended June 30, 2014 and 2013.

 

Item 4.          Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities and Exchange Act of 1934 is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our President and Chief Executive Officer, who is our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure.

 

As of June 30, 2014, our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial officer has concluded based upon the evaluation described above that, as of June 30, 2014, our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There were no changes to our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II — OTHER INFORMATION

 

Item 1A.  Risk Factors

 

You should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition or future results set forth under Item 1A. (Risk Factors) in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013. Except as noted below, there have been no material changes from the factors disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2013, although we may disclose changes to such factors or disclose additional factors from time to time in our future filings with the Securities and Exchange Commission.

 

Our Credit Facility imposes significant restrictions on our business, and if we default on our obligations, our lender would have a right to foreclose on substantially all our assets .

 

In June 2014, we entered into a loan and security agreement, or loan agreement, with Oxford Finance LLC, or Oxford, pursuant to which, subject to the conditions to borrowing thereunder, we borrowed an aggregate principal amount of $5.0 million and may, upon the satisfaction of certain conditions to the funding set forth in the credit agreement, borrow an additional aggregate principal amount of up to $15.0 million. The loans are secured by a lien on substantially all of our assets excluding intellectual property.

 

We could in the future incur additional indebtedness beyond amounts currently outstanding under our loan agreement with Oxford. Our debt combined with our other financial obligations and contractual commitments could have significant adverse consequences, including:

 

·                   requiring us to dedicate a substantial portion of cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;

·                   increasing our vulnerability to adverse changes in general economic, industry and market conditions;

·                   limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

·                   placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing options.

 

Additionally, with certain exceptions, the loan agreement prohibits us from:

 

·                   making any material dispositions of our assets, except for permitted dispositions;

·                   making any changes in our business, management, ownership, or business locations;

·                   entering into any merger or consolidation without Oxford’s consent;

·                   acquiring or making investments in any other person other than permitted investments;

·                   incurring any indebtedness, other than permitted indebtedness;

·                   granting or permitting liens against our assets, other than permitted liens;

·                   declaring or paying any dividends or making any other distributions; or

·                   entering into any material transaction with any affiliate, other than in the ordinary course of business.

 

We intend to satisfy our current and future debt service obligations with our cash and cash equivalents and short-term investments and funds from external sources. However, we may not have sufficient funds or may be unable to arrange for additional financing to pay the amounts due under our existing debt. Funds from external sources may not be available on acceptable terms, if at all. In addition, a failure to comply with the covenants under our debt instruments could result in an event of default under those instruments. In the event of an acceleration of amounts due under our debt instruments as a result of an event of default, we may not have sufficient funds and may be unable to arrange for additional financing to repay our indebtedness, and our lender could seek to enforce security interests in the collateral securing such indebtedness. In addition, the covenants under our debt instruments and the pledge of our assets as collateral limit our ability to obtain additional debt financing.

 

Item 2.          Unregistered Sales of Equity Securities and Use of Proceeds

 

Warrant

 

In June 2014, we entered into a loan and security agreement, or the loan agreement, with Oxford Finance LLC, or Oxford, pursuant to which we borrowed an initial aggregate principal amount of $5.0 million. In connection with entering into the loan agreement, we issued Oxford a warrant to purchase 8,230 shares of our common stock at an exercise price of $15.19 per share. The

 

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warrant will terminate on the earlier of June 30, 2019 and the closing of a merger or consolidation transaction in which the Company is not the surviving entity.

 

No underwriters were involved in the foregoing issuance of securities. The securities described in this Item 2 were issued to a single investor in reliance upon exemptions from the registration requirements of the Securities Act, as set forth in Section 4(a)(2) under the Securities Act, including Regulation 506 promulgated thereunder, relative to transactions by an issuer not involving any public offering. Oxford represented to us in connection with the issuance of the warrants that Oxford was an accredited investor and was acquiring the securities for its own account for investment purposes only and not with a view to, or for sale in connection with, any distribution thereof, and that Oxford could bear the risks of the investment.

 

Use of Proceeds from Initial Public Offering of Common Stock

 

On July 1, 2013, we closed the sale of 5,000,000 shares of common stock to the public at an initial public offering price of $14.00 per share.  On July 11, 2013, the underwriters exercised their over-allotment option in full, pursuant to which we sold an additional 750,000 shares of common stock at a price of $14.00 per share. The offer and sale of the shares in the IPO was registered under the Securities Act pursuant to registration statements on Form S-1 (File No. 333-188595), which was filed with the SEC on May 14, 2013 and amended subsequently and declared effective on June 25, 2013, and Form S-1MEF (File No. 333-189590), which was filed with the SEC on June 25, 2013 and declared effective on June 25, 2013. Following the sale of the shares in connection with the closing of our IPO, the offering terminated. The offering did not terminate before all the securities registered in the registration statements were sold. The underwriters of the offering were Credit Suisse Securities (USA) LLC and Citigroup Global Markets Inc., acting as joint book-running managers for the offering and as representatives of the underwriters. JMP Securities LLC and Stifel, Nicolaus & Company, Incorporated acting as co-managers for the offering.

 

We raised approximately $72.2 million in net proceeds after deducting underwriting discounts and commissions of approximately $5.6 million and other offering expenses of approximately $2.7 million. No offering expenses were paid directly or indirectly to any of our directors or officers (or their associates) or persons owning ten percent or more of any class of our equity securities or to any other affiliates.

 

As of June 30, 2014, we have used approximately $10.3 million of the net offering proceeds primarily to fund the Phase 2b clinical program of ETC-1002. We invested a significant portion of the balance of the net proceeds from the offering in cash equivalents and other short-term investments in accordance with our investment policy. None of such payments were direct or indirect payments to any of our directors or officers (or their associates), to persons owning ten percent or more of our common stock or to any other affiliates. As described in our final prospectus filed with the SEC on June 26, 2013 pursuant to Rule 424(b) under the Securities Act, we expect to use the remaining net proceeds from our IPO to continue to fund the clinical development of ETC-1002 through the completion of our ongoing Phase 2b clinical studies and end of Phase 2 meeting with the FDA, as well as for working capital and general corporate purposes, including funding the costs of operating as a public company. We currently expect to have our end of Phase 2 meeting with the FDA during the first half of 2015.

 

Item 6.          Exhibits

 

The exhibits filed or furnished as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which Exhibit Index is incorporated herein by reference.

 

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Table of Contents

 

SIGNATURES

 

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 thereunto duly authorized.

 

 

ESPERION THERAPEUTICS, INC.

 

 

 

 

August 12, 2014

By:

/s/ Tim M. Mayleben

 

 

Tim M. Mayleben

 

 

President and Chief Executive Officer

(Principal Executive Officer and Principal Financial Officer)

 

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Table of Contents

 

EXHIBIT INDEX

 

 

 

 

 

Incorporated by Reference to:

Exhibit
No.

 

Description

 

Form or
Schedule

 

Exhibit
No.

 

Filing
Date with
SEC

 

SEC File
Number

 

 

 

 

 

 

 

 

 

 

 

3.1

 

Amended and Restated Certificate of Incorporation of the Registrant.

 

S-1/A

 

3.1

 

6/12/2013

 

333-188595

 

 

 

 

 

 

 

 

 

 

 

3.2

 

Amended and Restated By-Laws of the Registrant.

 

S-1/A

 

3.2

 

6/12/2013

 

333-188595

 

 

 

 

 

 

 

 

 

 

 

4.1

 

Specimen Common Stock Certificate of the Registrant.

 

S-1/A

 

4.1

 

6/12/2013

 

333-188595

 

 

 

 

 

 

 

 

 

 

 

4.2

 

Warrant dated June 30, 2014 issued to Oxford Finance LLC.

 

8-K

 

4.1

 

7/2/2014

 

001-35986

 

 

 

 

 

 

 

 

 

 

 

10.1

 

Loan and Security Agreement, dated June 30, 2014, by and between the Registrant and Oxford Finance LLC.

 

8-K

 

10.1

 

7/2/2014

 

001-35986

 

 

 

 

 

 

 

 

 

 

 

10.2*

 

Third Amendment to Lease, effective as of May 1, 2014, by and between the Registrant and the Michigan Land Bank Fast Track Authority

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

31.1*

 

Certification of Principal Executive Officer and Principal Financial Officer pursuant to Exchange Act rules 13a-14 or 15d-14.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

32.1 +

 

Certification of Principal Executive Officer and Principal Financial Officer pursuant to Exchange Act rules 13a-14(b) or 15d-14(b) and 18 U.S.C. Section 1350.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.INS**

 

XBRL Instance Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.SCH**

 

XBRL Taxonomy Extension Schema Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.CAL**

 

XBRL Taxonomy Extension Calculation Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.DEF**

 

XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.LAB**

 

XBRL Taxonomy Extension Labels Linkbase Document.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

101.PRE**

 

XBRL Taxonomy Extension Presentation Link Document.

 

 

 

 

 

 

 

 

 


*                  Filed herewith.

 

+                  The certification furnished in Exhibit 32.1 hereto is deemed to be furnished with this Quarterly Report on Form 10-Q and will not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.

 

**           Attached as Exhibit 101 to this report are documents formatted in XBRL (Extensible Business Reporting Language). Pursuant to Rule 406T of Regulation S-T, the interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is otherwise not subject to liability under these sections.

 

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Exhibit 10.2

 

THIRD AMENDMENT TO LEASE

 

This THIRD AMENDMENT TO LEASE (this “Amendment”) is dated and made effective as of May 1, 2014 (the “Effective Date”) by and between the MICHIGAN LAND BANK FAST TRACK AUTHORITY (the “Landlord”) and ESPERION THERAPEUTICS, INC. (the “Tenant”) (collectively, the “Parties”).

 

R E C I T A L S

 

A. Landlord and Tenant are parties to that certain lease dated October 2, 2008, as amended by that certain First Amendment to Lease, dated November 15, 2011, that certain letter agreement dated March 29, 2013, and that certain Second Amendment to Lease, dated August 26, 2013 (as so amended, the “Lease”) of the Leased Premises consisting of 9,730 rentable square feet of space known as Lab B and Office B in the building located at 46701 Commerce Center Drive, Plymouth, Michigan.

 

B.                                              On November 14, 2012, the original Landlord, Michigan Life Sciences and Innovation Center, LLC, assigned the Lease to the Michigan Land Bank Fast Track Authority.

 

C.                                              Landlord and Tenant wish to amend the Lease to (i) extend the Term of the Lease, and (ii) amend certain other terms of the Lease.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby mutually acknowledged, Landlord and Tenant agree as follows:

 

1.                                                Capitalized Terms . Unless otherwise defined herein, all capitalized terms used in this Amendment shall have the meanings ascribed to them in the Lease, and all references in the Lease to the “Lease” or “this Lease” or “herein” or “hereunder” or similar terms or to any section thereof shall mean the Lease, or such section thereof, as amended by this Amendment.

 

2.                                               Leased Premises . The term “Leased Premises” in Article I - Fundamental Lease Provisions is replaced to read as follows:

 

Approximately 4,263 rentable square feet of laboratory space, which has been determined with a load factor of 1.4 (3,045 rentable square feet, commonly referred to as “Lab B” and “Room 006-1402G” multiplied by 1.4) all in the Building and as more particularly shown on the sketch attached hereto as Exhibit B.

 

3.                                               Sketch of Leased Premises .  Exhibit B attached to the Lease is replaced with the Exhibit B attached to this Amendment.

 

1



 

4.                                               Tenant’s Proportionate Share .  The term “Tenant’s Proportionate Share” in Article I - Fundamental Lease Provisions is amended from 16.89% to 7.40%.

 

5.                                                Initial Term . The Initial Term is hereby amended to read as follows: “Commencing on the Effective Date and continuing through April 30, 2017.” Such term shall be upon all of the current terms and conditions of the Lease, as so amended. The Base Rent, as amended, shall continue during this extended time.

 

6.                                               Renewal Terms . The phrase Renewal Terms is hereby amended to “Renewal Term” and to read as follows: “one (1) term of three (3) years.” Any references in the Lease to Renewal Terms shall be read in the singular as redefined herein.

 

7.                                       Lease Year .  The lease year shall be amended by adding the following:

 

Effective May 1, 2014, the Lease Year shall be the twelve month period commencing on May 1 and each anniversary thereof.

 

8.                                       Base Rent .  The Base Rent is amended by adding the following:

 

For the period commencing May 1, 2014 through April 30, 2015, the Base Rent shall be $36,966 (excluding the load factor of 1.4) for a monthly charge of $3,081 (excluding the load factor of 1.4). Base Rent shall be subject to increase as provided in Section 3.l (b) below. Notices of any such increases shall be provided to the Tenant at least 30 days prior to any such increase taking effect.

 

9.                                              Option to Extend .  Section 2.2(b) of the Lease is hereby amended to read as follows:

 

Provided an Event of Default (as defined in Section 10.1) has not occurred and be continuing, Tenant shall have the option to extend the Initial Term by the Renewal Term described in the Fundamental Lease Provisions by giving Landlord written notice of its election to extend the term of this Lease by such Renewal Term no later than February 1, 2017. The terms and conditions of this Lease shall apply during the Renewal Term.

 

10.                                       Utilities Cost; Additional Rent . Section 3.2, including subsections (a) through (g) of the Lease are currently in effect and shall remain in effect throughout the life of this Amendment.

 

11.                                       Vacated Space . This Amendment reduces the space being leased pursuant to the Lease. The Landlord accepts this reduction, and Tenant shall remove any and all of its equipment and other personal property from the vacated space by May 1, 2014. If the Tenant’s equipment and other personal property is not removed by May 1, 2014, then Tenant shall pay Landlord pro rata monthly rent, in accordance with the Lease, for every day the equipment and other personal property remains in the space.  Tenant shall provide Landlord with written

 

2



 

confirmation of the date its equipment and other personal property has been removed from the space within three (3) business days of such date.

 

12.                                         Ratification . Except as expressly modified by this Amendment, the Lease shall remain in full force and effect, and as further modified by this Amendment, is expressly ratified and confirmed by the parties hereto. This Amendment shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns, subject to the provisions of the Lease regarding assignment and subletting.

 

13.                                        Integration . This Amendment constitutes the entire Amendment between the Parties and supersedes all prior and contemporaneous agreements or understandings, whether written or oral, between the Parties with respect to the subject matter hereof.

 

14.                                        Governing Law . This Amendment shall be governed and construed in accordance with the laws of the State of Michigan.

 

15.                                        Counterparts and Authority . This Amendment may be executed in multiple counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same document. Landlord and Tenant each warrant to the other that the person or persons executing this Amendment on its behalf has or have authority to do so and that such execution has fully obligated and bound such party to all terms and provisions of this Amendment.

 

IN WITNESS WHEREOF, the undersigned executed this Amendment as of the date and year first written above

 

LANDLORD:

 

MICHIGAN LAND BANK FAST TRACK AUTHORITY

 

 

 

 

 

 

 

By:

/s/ Michele Wildman

 

Name:

Michele Wildman

 

Title:

Interim Executive Director

 

 

 

 

 

TENANT:

 

ESPERION THERAPEUTICS, INC.

 

 

 

 

 

 

 

By:

/s/ Tim Mayleben          5/7/14

 

Name:

Tim Mayleben

 

Title

President & CEO

 

 

3



 

Exhibit B

 

Sketch of Leased Premises

 

 

B-1



 

 

ABBREVIATIONS/ KEY

 

(BC) BUILDING COMMON- SHARED EXPENSE- ALL TENANTS

(BR) BUILDING RENTABLE- HOURLY/ PRORATED PER USE

(OC) OFFICE COMMON- SHARED EXPENSE OFFICE TENANTS

(OR} OFFICE RENTABLE- HOURLYI PRORATED PER USE

(VC)  VIVARIUM COMMON”- SHARED EXPENSE- VIVARIUM TENANTS

(VR)  VlVARIUM RENTABLE- HOURLY/ PRORATED PER USE

 

SPACES WITH NO SUCH DESIGNATION ARE LEASABLE AS STANDALONE SPACES. COMMON & RENTED SPACE AT LABS DEPENDENT ON LEASING PLAN.

 


Exhibit 31.1

 

Certification

 

I, Tim M. Mayleben certify that:

 

1.                       I have reviewed this quarterly report on Form 10-Q for the period ended June 30, 2014 of Esperion Therapeutics, Inc.;

 

2.                       Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.                       Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.                       I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

a.                      Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.                      (Paragraph omitted pursuant to SEC Release Nos. 33-8238/34-47986 and 33-8392/34-49313);

 

c.                       Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.                      Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.                       I have disclosed, based on my most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a.                 All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.                 Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

 

Date: August 12, 2014

/s/ Tim M. Mayleben

 

Tim M. Mayleben

 

President and Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)

 


Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the quarterly report on Form 10-Q of Esperion Therapeutics, Inc. (the “Company”) for the period ended June 30, 2014, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Tim M. Mayleben, President and Chief Executive Officer of the Company, hereby certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, 18 U.S.C. Section 1350, that, to my knowledge as of the date hereof:

 

1)                       the Report which this statement accompanies fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2)                       the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 12, 2014

/s/ Tim M. Mayleben

 

Tim M. Mayleben

 

President and Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)