0001193125-14-310152.txt : 20140814 0001193125-14-310152.hdr.sgml : 20140814 20140814161439 ACCESSION NUMBER: 0001193125-14-310152 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20140630 FILED AS OF DATE: 20140814 DATE AS OF CHANGE: 20140814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BG Medicine, Inc. CENTRAL INDEX KEY: 0001407038 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 043506204 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-33827 FILM NUMBER: 141042923 BUSINESS ADDRESS: STREET 1: 880 WINTER STREET STREET 2: SUITE 210 CITY: WALTHAM STATE: MA ZIP: 02451 BUSINESS PHONE: 781-890-1199 MAIL ADDRESS: STREET 1: 880 WINTER STREET STREET 2: SUITE 210 CITY: WALTHAM STATE: MA ZIP: 02451 10-Q 1 d752642d10q.htm FORM 10-Q Form 10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

 

¨ 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: 001-33827

 

 

BG MEDICINE, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   04-3506204

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

880 Winter Street, Suite 210

Waltham, Massachusetts

  02451
(Address of principal executive offices)   (Zip Code)

(781) 890-1199

(Registrant’s telephone number, including area code)

 

 

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  ¨

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  ¨

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   ¨    Accelerated filer   ¨
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    Smaller reporting company   x

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

As of July 31, 2014, the registrant had 34,417,249 shares of common stock outstanding.

 

 

 


Table of Contents

BG Medicine, Inc.

Index to Form 10-Q

 

          Page  

PART I: FINANCIAL INFORMATION

  

Item 1.

  

Financial Statements

  
  

Unaudited Condensed Consolidated Balance Sheets as of June 30, 2014 and December 31, 2013

     3   
  

Unaudited Condensed Consolidated Statements of Operations for the Three and Six Month Periods Ended June  30, 2014 and 2013

     4   
  

Unaudited Condensed Consolidated Statements of Cash Flows for the Six Month Periods Ended June  30, 2014 and 2013

     5   
  

Notes to Unaudited Condensed Consolidated Financial Statements

     6   

Item 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     10   

Item 3.

  

Quantitative and Qualitative Disclosures About Market Risk

     21   

Item 4.

  

Controls and Procedures

     21   

PART II: OTHER INFORMATION

  

Item 1.

  

Legal Proceedings

     22   

Item 1A.

  

Risk Factors

     22   

Item 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

     22   

Item 3.

  

Defaults Upon Senior Securities

     22   

Item 4.

  

Mine Safety Disclosures

     22   

Item 5.

  

Other Information

     22   

Item 6.

  

Exhibits

     23   


Table of Contents

PART I: FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

BG Medicine, Inc. and Subsidiary

 

 

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

 

         June 30, 2014         December 31, 2013  
     (in thousands, except share and per share data)  

Assets

    

Current assets

    

Cash

   $ 9,538      $ 7,751   

Accounts receivable

     353        319   

Inventory

     554        459   

Prepaid expenses and other current assets

     352        306   
  

 

 

   

 

 

 

Total current assets

     10,797        8,835   

Property and equipment, net

     154        192   

Intangible assets, net

     163        192   

Deposits and other assets

     126        134   
  

 

 

   

 

 

 

Total assets

   $ 11,240      $ 9,353   
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity (Deficit)

    

Current liabilities

    

Term loan, current portion

     4,406        4,353   

Accounts payable

     1,012        965   

Accrued expenses

     924        1,993   

Other current liabilities

     69        39   
  

 

 

   

 

 

 

Total current liabilities

     6,411        7,350   

Term loan, net of current portion

     745        2,961   

Other liabilities

     102        111   
  

 

 

   

 

 

 

Total liabilities

     7,258        10,422   
  

 

 

   

 

 

 

Commitments and contingencies (Note 5)

    

Stockholders’ equity (deficit)

    

Common stock; $.001 par value; 100,000,000 shares authorized at June 30, 2014 and December 31, 2013; 34,417,249 and 27,936,222 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively

     34        28   

Additional paid-in capital

     161,234        151,841   

Accumulated deficit

     (157,286     (152,938
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     3,982        (1,069
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity (deficit)

   $ 11,240      $ 9,353   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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BG Medicine, Inc. and Subsidiary

 

 

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  
     (in thousands, except share and per share data)  

Revenues:

        

Product revenues

   $ 799      $ 972      $ 1,538      $ 1,792   

Service revenues

     —         34        —         102  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

     799        1,006        1,538        1,894   
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and operating expenses:

        

Product costs

     281        353        529        633   

Service costs

     —         34        —         102  

Research and development

     573        1,117        1,133        2,493   

Selling and marketing

     733        1,782        1,421        3,926   

General and administrative

     1,183        2,269        2,373        4,090   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     2,770        5,555        5,456        11,244   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (1,971     (4,549     (3,918     (9,350

Non-cash consideration associated with stock purchase agreement

     —          —         —         (329

Interest income

     —          6        2        10   

Interest expense

     (199     (295     (432     (584

Other income

     1        1        —          4   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (2,169   $ (4,837   $ (4,348   $ (10,249
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share - basic and diluted

   $ (0.06   $ (0.18   $ (0.14   $ (0.39
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares outstanding used in computing per share amounts - basic and diluted

     33,915,465        27,649,879        30,942,514        26,490,682   
  

 

 

   

 

 

   

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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BG Medicine, Inc. and Subsidiary

 

 

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

                     Six Months Ended June 30,                   
     2014     2013  
     (in thousands)  

Cash flows from operating activities

    

Net loss

   $ (4,348   $ (10,249

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

    

Depreciation and amortization

     67        100   

Stock-based compensation

     380        633   

Non-cash interest expense

     116        99   

Non-cash consideration associated with stock purchase agreement

     —         329   

Gain on sale of property and equipment

     —         (53

Changes in operating assets and liabilities

    

Restricted cash

     —         102   

Accounts receivable

     (34     (7

Inventory

     (95     178   

Prepaid expenses and other assets

     (38     (115

Accounts payable, accrued expenses and other liabilities

     (1,067     275   

Deferred revenue and customer deposits

     27        (100
  

 

 

   

 

 

 

Net cash flows used in operating activities

     (4,992     (8,808
  

 

 

   

 

 

 

Cash flows from investing activities

    

Proceeds from the sale of property and equipment

     —         80   
  

 

 

   

 

 

 

Net cash flows provided by investing activities

     —         80   
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from public offering

     9,238        13,058   

Costs related to public offering

     (243     (287

Payments on term loan

     (2,240     (666

Proceeds from ESPP purchases

     2        13   

Proceeds from the exercise of stock options

     22        27   
  

 

 

   

 

 

 

Net cash flows provided by financing activities

     6,779        12,145   
  

 

 

   

 

 

 

Net increase in cash

     1,787        3,417   

Cash, beginning of period

     7,751        12,786   
  

 

 

   

 

 

 

Cash, end of period

   $     9,538      $ 16,203   
  

 

 

   

 

 

 

Supplemental disclosure of cash flow information

    

Cash paid for interest

   $ 319      $ 455   

Supplemental disclosure of non-cash activities

    

Issuance of common stock warrants accounted for as debt discount

   $             —        $             163   

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

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BG Medicine, Inc. and Subsidiary

 

 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1. Description of Business and Basis of Presentation

Description of Business

BG Medicine, Inc. (“BG Medicine” or the “Company”) is a commercial stage company that is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. The Company has one diagnostic test that is U.S. Food and Drug Administration, or FDA, cleared and CE marked, the BGM Galectin-3® Test, an in vitro diagnostic device that quantitatively measures galectin-3 levels in blood plasma or serum for use as an aid in assessing the prognosis of chronic heart failure. It is currently available as a blood test in the United States and the European Union, or EU. The Company is also developing a pipeline of diagnostic products including the CardioSCORE™ Test, a biomarker-based blood test designed as an aid in the assessment of near-term risk for significant cardiovascular events, such as heart attack and stroke.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States and in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. The interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position at June 30, 2014 and results of operations and cash flows for the interim periods ended June 30, 2014 and 2013.

The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates and to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. The results for the six months ended June 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014 or for any other interim period or for any other future year. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.

At June 30, 2014, the Company had cash totaling $9.5 million, an outstanding balance of $5.2 million under a secured term loan facility, and stockholder’s equity of $4.0 million. During the six months ended June 30, 2014, the Company incurred a net loss of $4.3 million and used cash in operating activities totaling $5.0 million. The Company expects to continue to incur losses and use cash in operating activities during the remainder of 2014 and beyond.

On April 8, 2014, the Company closed a follow-on underwritten public offering of 6,452,000 shares of its common stock, at an offering price of $1.55 per share, for gross proceeds of $10.0 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million.

Effective January 1, 2014, the payment rate at which the Company’s BGM Galectin-3 Test is reimbursed by the Centers for Medicare and Medicaid Services (“CMS”), was increased to $30.01 from $17.80 per test. The Company expects to increase its revenues through higher reimbursement levels and by engaging additional laboratory providers and expects to decrease its operating expenses. However, the Company is in the early stages of commercializing its BGM Galectin-3 Test. Interest in the BGM Galectin-3 Test is increasing as a result of the Company’s market development activities, although it has not yet translated into significant revenue. In order to achieve profitability, the Company will need to generate significant product revenues.

As further described in Note 4, the Company’s term loan is secured by substantially all of the Company’s assets. The loan and security agreement contains customary events of default that entitle the lenders to cause any or all of the Company’s indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including the Company’s cash. The events of default include, among others, the occurrence of a material adverse effect which could cause the lender to accelerate the payments by the Company under the term loan. The Company has determined that the risk of a subjective acceleration under the material adverse effect clause, absent acceleration under other enumerated events of default, is remote.

The Company believes that its existing cash and availability of up to $12.0 million under its common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire”), (Note 6) pursuant to which approximately $4.1 million would have been available to the Company through the sale of available shares over the purchase period ending June 30, 2014, will be sufficient to fund its

 

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BG Medicine, Inc. and Subsidiary

 

 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

operations and service its debt into the second quarter of 2015. The Company has not yet sold any shares under its common stock purchase agreement with Aspire, which expires in May 2015. In order for the Company to sell shares to Aspire under the Purchase Agreement, the Company’s common stock must trade above the $1.00 minimum floor price set forth in the Purchase Agreement. Until the Company generates significant product revenues to reach cash breakeven, the Company will need to raise additional funds to finance its operations and service its existing debt beyond the second quarter of 2015. The Company may not be able to obtain adequate financing to do so when necessary, and the terms of any financings may not be advantageous to it.

The above circumstances along with the Company’s history and near term forecast of incurring net losses and negative operating cash flows raise substantial doubt regarding its ability to continue as a going concern beyond the second quarter of 2015. The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.

 

2. Significant Accounting Policies

Product Revenues

Product revenues are recognized when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred and risk of loss has passed; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured.

The Company sells its products through supply agreements with laboratory testing services and diagnostic testing distributors and directly to hospitals and clinics. The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price.

Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue.

The Company does not currently provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship.

Service Revenues

Service revenues are primarily attributable to the activities from the High Risk Plaque initiative, for which all revenue has been recorded as of December 31, 2013. The Company does not expect to record service revenues in 2014 or beyond.

Inventory

Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following:

 

(in thousands)        June 30, 2014          December 31, 2013  

Raw materials

   $ 86       $ 107   

Finished goods

     468         352   
  

 

 

    

 

 

 

Total inventories

   $ 554       $ 459   
  

 

 

    

 

 

 

Net Loss Per Share

Basic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented.

 

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BG Medicine, Inc. and Subsidiary

 

 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  
     (in thousands, except share and per share data)  

Net loss

   $ (2,169   $ (4,837   $ (4,348   $ (10,249

Weighted average number of shares - basic and diluted

     33,915,465        27,649,879        30,942,514        26,490,682   

Net loss per share - basic and diluted

   $ (0.06   $ (0.18   $ (0.14   $ (0.39

For the three and six months ended June 30, 2014 and 2013, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported:

 

     Three and Six Months Ended June 30,  
     2014      2013  

Options to purchase common stock

     3,042,661         2,913,192  

Warrants to purchase common stock

     864,555         864,555   

 

3. Fair Value of Financial Instruments

At June 30, 2014, the Company’s financial instruments consist of cash, accounts receivable, accounts payable and debt. The carrying amounts of accounts receivable, accounts payable and short-term debt are considered reasonable estimates of their fair value, due to the short maturity of these instruments. The carrying amount of the long term debt was considered a reasonable estimate of fair value because the Company’s effective interest rate is near current market rates for instruments with similar characteristics.

 

4. Term Loan

On February 10, 2012, the Company entered into a secured term loan facility, and a term loan in the aggregate principal amount of $10.0 million was funded upon the closing of the transaction.

The term loan accrues interest at a rate of 8% per annum plus the higher of (a) the 3-month LIBOR rate or (b) 1.25%. The interest rate in effect at June 30, 2014 was 9.25%. Interest only payments were made for the first twelve months of the loan term. Following that initial twelve month period, principal and interest payments are required to be paid on a monthly basis through maturity at September 2015. The term loan is secured by substantially all of the Company’s assets, other than its intellectual property, for which the Company has provided a negative pledge. The loan and security agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to incur indebtedness, merge or consolidate, dispose of assets, make acquisitions, pay dividends or make distributions, or repurchase stock. In addition, the loan and security agreement contains customary events of default that entitle the lenders to cause any or all of the Company’s indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including the Company’s cash. The events of default include, among others, non-payment of principal and interest when due, inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency and the occurrence of a material adverse effect (as defined in the loan and security agreement).

May 2013 Loan Amendment

In May 2013, the Company amended its loan and security agreement to allow for a three month deferral of principal payments beginning May 1, 2013 and to allow for up to an additional three months of deferral based on the Company meeting certain minimum liquidity requirements, as defined in the amendment. The Company made principal payments in March and April 2013 prior to the signing of the amendment. The Company did not meet the additional liquidity requirements, as defined in the amendment, and, accordingly, principal payments resumed on August 1, 2013. The amendment also increased certain loan fees by $50,000, and amended the terms of the warrants, as discussed below.

 

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BG Medicine, Inc. and Subsidiary

 

 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

Warrants

In connection with the loan facility, the Company initially issued to the lenders warrants to purchase 36,657 shares of its common stock with an exercise price of $6.82 per share. The warrants expire ten years from the date of issuance. The warrants were valued using the Black-Scholes option pricing model using the following assumptions: fair value of the underlying common stock of $8.51 per share; volatility of 70%; no dividend yield; risk free interest rate of 1.96%; and an expected life of ten years. The relative fair value of the warrants, aggregating $240,000, has been accounted for as a debt discount and is being recognized as interest expense over the term of the loan using the effective interest method. These warrants have been classified as equity instruments and are included within additional paid-in capital. As part of the May 2013 amendment to the loan and security agreement, the number of shares for which the warrants were exercisable increased by 110,401 shares and the exercise price of the warrants was adjusted to $1.70 per share. At the loan modification date, the Company valued the warrants using the Black-Scholes option pricing model and recorded the incremental value of the increased number of shares for which the warrants are exercisable as additional debt discount in the amount of $163,000, which is being recognized as additional interest expense over the remaining term of the loan using the effective interest method.

At June 30, 2014, the Company had $5.2 million outstanding under the term loan.

 

5. Commitments and Contingencies

From time to time, the Company may be subject to various legal proceedings and claims arising in the ordinary course of business. The Company assesses contingencies to determine the degree of probability and range of possible loss for potential accrual in its financial statements. An estimated loss contingency is accrued in the financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated.

The Company was involved in litigation with a former research collaborator resulting from the Company’s termination of its participation in the collaboration. In April 2014, the Company settled this matter for an amount that had been accrued at December 31, 2013. No further losses are expected related to this matter. No other amounts related to contingencies are accrued at June 30, 2014.

 

6. Common Stock Purchase Agreement

On January 24, 2013, the Company entered into a Common Stock Purchase Agreement (“Purchase Agreement”), with Aspire Capital Fund, LLC to purchase, at the Company’s option, up to an aggregate of $12.0 million of shares of its common stock over a two-year term, which expires in May 2015. Under the Purchase Agreement, the Company initially issued 132,743 shares of its common stock as a commitment fee. The Company’s sales to Aspire will be made subject to market conditions, in light of its capital needs and under various limitations contained in the Purchase Agreement, including a floor price of $1.00 per share required by the Purchase Agreement. The Company has not yet sold any shares under the Purchase Agreement, which expires in May 2015.

Over the term of the Purchase Agreement, assuming the Company’s common stock is trading above the $1.00 floor price that is required to use the facility, the Company has two ways to elect to sell common stock to Aspire on any business day the Company selects: (1) through a regular purchase of up to 100,000 shares at prices based on the market price of the Company’s common stock prior to the time of each sale, and (2) through a volume weighted average price (“VWAP”), purchase of a number of shares up to 30% of the volume traded on the purchase date at a price equal to the lesser of the closing sale price or 95% of the VWAP for such purchase date.

The Company also entered into a Registration Rights Agreement with Aspire, which requires, among other things, that the Company maintain the effectiveness of the Company’s registration statement that registered the shares issued and issuable to Aspire under the Purchase Agreement.

 

7. Follow-on Public Offerings

On January 30, 2013, the Company closed a follow-on underwritten public offering of 6,900,000 shares of its common stock, at an offering price of $2.00 per share, for gross proceeds of $13.8 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $12.8 million.

On April 8, 2014, the Company closed a follow-on underwritten public offering of 6,452,000 shares of its common stock, at an offering price of $1.55 per share, for gross proceeds of $10.0 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million.

 

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following in conjunction with our unaudited condensed consolidated financial statements and the related notes thereto that appear elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto and under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2013. In addition to historical information, the following discussion and analysis includes forward-looking information that involves risks, uncertainties and assumptions. Our actual results and the timing of events could differ materially from those anticipated by these forward-looking statements as a result of many factors, including those discussed under “Risk Factors” in Item 1A. of our Annual Report on Form 10-K for the year ended December 31, 2013.

Overview

We are developing and commercializing diagnostic products that may be used to help guide the care and management of patients who suffer from heart failure and related disorders.

Our BGM Galectin-3 Test is our first U.S. Food and Drug Administration, or FDA, cleared and CE Marked diagnostic product. It is currently available as a blood test in the United States and the European Union, or EU. Our BGM Galectin-3 Test was included in the 2013 American College of Cardiology Foundation and the American Heart Association Guideline for the Management of Heart Failure.

We market and sell our BGM Galectin-3 Test kits to health care clinical laboratories, hospitals, and health care providers. We hope to accelerate the clinical and commercial adoption of galectin-3 testing by generating, publishing and publicizing data derived from clinical research studies that have incorporated our BGM Galectin-3 Test and by expanding our BGM Galectin-3 Test’s indications for use. We have entered into licensing agreements with leading diagnostic instrument manufacturers to develop and commercialize galectin-3 assays that will be performed on automated platforms that have been incorporated into routine practice in laboratories throughout the world.

We are developing a pipeline of diagnostic products by leveraging our intellectual property and the mining of data generated from the BioImage Study, a patient cohort and specimen repository to which we have exclusive access for the development of diagnostic products. Among the products in development is our CardioSCORE™ Test, a biomarker-based blood test designed as an aid in the assessment of near-term risk for significant cardiovascular events, such as heart attack and stroke.

Our BGM Galectin-3 Test

Our BGM Galectin-3 Test is our first FDA cleared and CE Marked diagnostic product. It is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or plasma by enzyme linked immunosorbent assay, or ELISA, on a microtiter plate platform. Heart failure patients with elevated galectin-3 levels as measured using our BGM Galectin-3 Test have been found to be at significantly greater risk of adverse outcomes, including death or hospitalization. Measurement of this protein biomarker is intended to be used in conjunction with clinical evaluation.

Galectins are a family of proteins that play many important roles in inflammation, immunity and cancer. Galectin-3, a member of this family of proteins, is a protein biomarker that has been shown to play an important role in heart failure in both animal and human studies. In animal experiments, administration of galectin-3 to the heart led to the development of cardiac fibrosis, or stiffening, in the heart muscle, a process that is often referred to as cardiac remodeling. In these animal studies, adverse remodeling reduced the heart’s ability to pump normally, causing the animals to develop heart failure. This link between galectin-3 and cardiac remodeling is significant and suggests that galectin-3 may be a useful biomarker for adverse cardiac remodeling, an important determinant of the clinical outcome of patients suffering from heart failure. We have obtained an exclusive worldwide license to certain galectin-3 rights that relate to the association of this protein biomarker with heart failure. We have also filed several of our own patent applications related to galectin-3. Our BGM Galectin-3 Test is currently available as a blood test in the United States and the EU.

Automated Testing For Galectin-3

Overview

We believe that automation of our galectin-3 test will broaden its acceptance by laboratory customers and, as a result, accelerate its clinical adoption. To that end, we have entered into licensing and commercialization agreements with four leading diagnostic instrument manufacturers to develop and commercialize automated instrument versions of our galectin-3 test. We have entered into

 

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worldwide license, development and commercialization agreements with Abbott Laboratories, or Abbott, bioMérieux SA, or bioMérieux, Siemens Healthcare Diagnostics Inc., or Siemens, and Alere Inc., or Alere. These diagnostic instrument manufacturers account for a significant percentage of the automated laboratory testing instruments that are used throughout the world. The installed customer base of these automated partners reflects all major segments of the diagnostics market, including hospital laboratories, national reference laboratories, regional laboratories and others.

Progress to Date

In January 2013, bioMérieux obtained a CE Mark for its VIDAS® Galectin-3 assay and initiated its commercial launch in the EU. The VIDAS® Galectin-3 assay was developed by bioMérieux for the quantitative measurement of galectin-3 levels in blood using the bioMérieux VIDAS® automated and multiparametric immunoassay testing system.

In April 2013, Abbott obtained a CE mark for its ARCHITECT® Galectin-3 assay and initiated its commercial launch in the EU. Abbott is offering the ARCHITECT® Galectin-3 assay on its ARCHITECT® immunoassay platform. In the United States, Fujirebio Diagnostics, Incorporated, or Fujirebio, on behalf of Abbott, is the first of our automated partners to have filed for 510(k) regulatory clearance of an automated version of the galectin-3 test. Fujirebio is developing the test for use on Abbott’s ARCHITECT® immunochemistry instrument platform. Fujirebio initially submitted its 510(k) to the FDA in July 2012. Subsequently, Fujirebio received a letter from the FDA requesting additional information on various matters, including the geographic composition of the patient cohort that provided the blood samples used to support the 510(k) submission. Due to the nature of the additional information requested and the time required to address the FDA’s questions, Fujirebio was unable to submit a complete response to the FDA by the FDA-designated deadline on February 25, 2013 and withdrew the submission. Fujirebio submitted its new 510(k) to the FDA in February 2014.

Reimbursement for Galectin-3 Testing

Approximately 70% of heart failure patients in the United States are of Medicare age. Therefore, reimbursement by Medicare is of considerable interest to our laboratory customers. In the United States, for the 2014 calendar year, the Centers for Medicare and Medicaid Services, or CMS, published a 2014 Medicare national limitation amount for the galectin-3 blood test (analyte-specific CPT® Code 82777) at the amount of a crosswalked test (analyte-specific CPT® Code 84244) whose 2014 national limitation amount is $30.01. This national limitation replaces the galectin-3 blood test’s national limitation amount of $17.80 that was effective in 2013. The 2014 national limitation amount applies across the U.S. except in Ohio and West Virginia where rates of $23.99 and $26.40, respectively, will apply. In Europe, the Company’s sales efforts are currently directed to hospital situated emergency departments whose reimbursement is covered under the hospital budgeting process.

Our Product Pipeline

New Clinical Claims and Indications for the BGM Galectin-3 Test

We believe that the clinical and commercial value of our BGM Galectin-3 Test may extend beyond its current indications for use. We expect to pursue new clinical claims and indications for its use in assessing heart failure, as well as in related disorders. Expansion of the product label to include new clinical claims and indications for use will require additional clinical studies and clearance, or approval, by regulatory bodies, such as the FDA, and inclusion in our CE Mark for use in the EU.

CardioSCORE™ Test

Our CardioSCORE test is a multi-analyte biomarker-based blood test that is designed as an aid in the assessment of near-term risk for significant atherothrombotic cardiovascular events, such as heart attack and ischemic stroke. The CardioSCORE test is a proprietary in vitro diagnostic multi-analyte assay in which the levels of multiple biomarkers are measured in blood and the results are mathematically integrated to yield a single numerical score that is predictive of an individual’s near-term atherothrombotic cardiovascular risk. Our development work indicates that the CardioSCORE test has the potential to offer significant improvement over conventional risk factor-based diagnostics, such as the Framingham Risk Score, to identify near-term cardiovascular risk.

In December 2012, we obtained a CE Mark for the CardioSCORE test, which will enable us to market the test in Europe and other countries that recognize CE Mark. However, as a result of our decision to focus our efforts on increasing the adoption and sales of our galectin-3 test, we have decided to redirect investments from a launch of the CardioSCORE test in Europe to support our galectin-3 efforts. We may move forward with a European launch in test markets, when and if appropriate partnership opportunities arise.

In December 2011, we submitted a 510(k) to the FDA in order to obtain regulatory clearance to market the CardioSCORE test in the United States as an aid in the assessment of near-term risk for significant cardiovascular events, such as heart attack and stroke. In

 

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response to this submission, the FDA requested that we engage an independent committee of physicians to conduct a medical review and adjudication of clinical endpoints reported in the submission. Due to the time involved in responding to this request, we withdrew the 510(k) on August 8, 2012. Our review also included the assessment of sample stability and the evaluation of other technical issues raised by the FDA. We continue to analyze the results of the medical review. When completed, the results obtained from our analysis of data collected from the review will guide our go-forward regulatory, commercial and investment strategy for the CardioSCORE test in the United States.

BioImage Study Patient Cohort and Banked Specimens

We have exclusive rights to diagnostic inventions arising from our analysis of data generated from the BioImage Study, a proprietary observational and community-based cohort of over 6,800 individuals who have been followed since 2009. Baseline blood serum, plasma, and DNA and RNA samples collected from all participants have been stored and are available for our analysis. In addition, insurance claims data, including information regarding diagnoses, procedures, and therapies related to over 1,200 non-fatal cardiovascular events that were experienced by participants in the cohort over the more than four years since follow-up was initiated is available to us for data mining. We believe that this asset provides us with a unique and proprietary platform from which we may develop new diagnostic products.

Results of Operations

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

Revenues

Our product revenues are primarily derived from sales of the BGM Galectin-3 Test. Our product revenues have tended to be concentrated with a small number of laboratory providers generating a significant percentage of our revenues in any given reporting period. As a result, the timing of orders from these customers may fluctuate significantly from month to month and quarter to quarter.

The following table summarizes our total revenues for the three months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,         
             2014                      2013              %
  Decrease  
 
     (in thousands)         

Total Revenues

        

Product

   $ 799       $ 972         (18 %) 

Service

     —          34         (100 %) 
  

 

 

    

 

 

    

Total Revenues

   $    799       $ 1,006         (21 %) 
  

 

 

    

 

 

    

Total revenues decreased by 21%, or $207,000, to $799,000 in the three months ended June 30, 2014 from $1.0 million in the three months ended June 30, 2013.

Product revenues are comprised primarily of sales of our BGM Galectin-3 Test and decreased in the three months ended June 30, 2014 by $173,000, to $799,000, from $972,000 in the three months ended June 30, 2013. The decrease in product revenues resulted primarily from a $141,000 decline in orders from our largest customer and a $90,000 decline in purchases relating to independent research studies which, typically, vary from quarter to quarter. This decrease was offset by increased revenues of $58,000 from product sales to other clinical laboratory customers. We have not yet recorded significant royalties from Abbott or bioMerieux’s automated versions of their galectin-3 assays.

Service revenues decreased by 100%, or $34,000, to $0 in the three months ended June 30, 2014 from $34,000 in the three months ended June 30, 2013. Service revenues in 2013 related to the High Risk Plaque initiative program and there is no further revenue to recognize under the project. Accordingly, we do not expect to record service revenues for the remainder of 2014 and beyond.

Product Costs

Our product costs consist of expenses related to our BGM Galectin-3 Test. These expenses include the contract-manufacturing of the tests, the medical device excise tax, freight and royalty expenses payable to the licensor of certain intellectual property relating to galectin-3 based on revenues generated from the sales of the test. Product costs exclude depreciation and amortization included in operating expenses.

 

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The following table provides information with respect to our product costs and product margins for the three months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,        
     2014     2013     %
Increase
(Decrease)
 
     (in thousands)        

Product costs

   $ 281      $ 353        (20 %) 

Product gross margin

     65     64     1

Product costs decreased by 20%, or $72,000, to $281,000 in the three months ended June 30, 2014 as compared to $353,000 in the three months ended June 30, 2013. The decrease in product costs was commensurate with the decrease in product revenue.

Service Costs

Our service costs consist primarily of expenses incurred to support our initiatives, collaborative research and development agreements and biomarker discovery and analysis services agreements. These expenses include outside services and internal personnel costs, laboratory consumables, license fees and overhead expenses.

The following table provides information with respect to our service costs for the three months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,         
               2014                        2013              %
  Decrease  
 
     (in thousands)         

Service costs

   $           —        $           34         (100 %) 

Service costs decreased by 100%, or $34,000, to $0 in the three months ended June 30, 2014 as compared to $34,000 in the three months ended June 30, 2013. Service costs in the three months ended June 30, 2013 consisted of costs related to the High Risk Plaque initiative program. There are no further costs to incur under this project. Accordingly, we do not expect to record service costs for the remainder of 2014 and beyond.

Operating Expenses

The following table summarizes our operating expenses for the three months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,         
             2014                      2013              %
  Decrease  
 
     (in thousands)         

Operating expenses

        

Research and development

   $ 573       $ 1,117         (49 %) 

Selling and marketing

     733         1,782         (59 %) 

General and administrative

     1,183         2,269         (48 %) 
  

 

 

    

 

 

    

Total operating expenses

   $ 2,489       $ 5,168         (52 %) 
  

 

 

    

 

 

    

Research and development

Historically, we have incurred research and development expenses in connection with our internal biomarker discovery and development efforts. Our research and development expenses consist primarily of direct personnel costs, fees for consultants and outside services, laboratory consumables and overhead expenses. We use consultants and outside services to provide expertise or services that we do not have.

Research and development expenses decreased by 49%, or $544,000, to $573,000 in the three months ended June 30, 2014 as compared to $1.1 million in the three months ended June 30, 2013. The decrease in research and development expenses for the current

 

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period over the prior period was primarily attributable to a decrease in professional service costs by $241,000, a decrease in costs related to the CardioSCORE medical review and adjudication process by $127,000, a decrease in biomarker discovery research costs by $125,000, and a decrease in product development costs associated with CardioSCORE and the automated platform by $51,000.

Selling and marketing

Selling and marketing expenses consist primarily of costs related to supporting commercialization activities associated with our BGM Galectin-3 Test.

Selling and marketing expenses decreased by 59%, or $1.0 million, to $733,000 in the three months ended June 30, 2014 as compared to $1.8 million in the three months ended June 30, 2013. The decreased expenditures were primarily due to costs related to refocusing our marketing activities from market education to commercialization of $476,000 and a decrease in compensation related costs and travel of $465,000.

General and administrative

General and administrative expenses consist primarily of personnel-related expenses, allocated occupancy costs, and expenses related to operating as a public company. These expenses include legal and regulatory costs, directors’ and officers’ insurance premiums, investor relation services, and accounting and financial reporting expenses.

General and administrative expenses decreased by 48%, or $1.1 million, to $1.2 million in the three months ended June 30, 2014 as compared to $2.3 million in the three months ended June 30, 2013. This decrease is due primarily to a decrease in compensation related charges and travel of $774,000 and decreased legal and audit related fees of $186,000.

Other income and expense

The following table summarizes other (expense) income for the three months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,        
             2014                     2013             %
  Decrease  
 
     (in thousands)        

Other (expense) income

      

Interest income/other (expense) income

   $ 1      $ 7        (86 %) 

Interest expense

     (199     (295     (33 %) 
  

 

 

   

 

 

   

Total other (expense) income

   $ (198   $ (288     (31 %) 
  

 

 

   

 

 

   

Other (expense) income decreased by $90,000 primarily resulting from less interest expense during the three months ended June 30, 2014 due to lower loan balances on our term loan because of our principal payments.

Results of Operations

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

Revenues

The following table summarizes our total revenues for the six months ended June 30, 2014 and 2013:

 

     Six Months Ended June 30,         
               2014                        2013              %
  Decrease  
 
     (in thousands)         

Total Revenues

        

Product

   $ 1,538       $ 1,792         (14 %) 

Service

     —           102         (100 %) 
  

 

 

    

 

 

    

Total Revenues

   $ 1,538       $ 1,894         (19 %) 
  

 

 

    

 

 

    

 

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Total revenues decreased by 19%, or $356,000, to $1.5 million in the six months ended June 30, 2014 from $1.9 million in the six months ended June 30, 2013.

Product revenues are comprised primarily of sales of our BGM Galectin-3 Test and decreased in the six months ended June 30, 2014 by $254,000, to $1.5 million, from $1.8 million in the six months ended June 30, 2013. The decrease in product revenues resulted primarily from a decline in orders due to inclement weather in the Eastern half of the United States during the first quarter of 2014, sales to our largest customer and purchases relating to independent research studies which, typically, vary from quarter to quarter. We have not yet recorded significant royalties from Abbott or bioMerieux’s automated versions of their galectin-3 assays.

Service revenues decreased by 100%, or $102,000, to $0 in the six months ended June 30, 2014 from $102,000 in the six months ended June 30, 2013. Service revenues in 2013 related to the High Risk Plaque initiative program and there is no further revenue to recognize under the project. Accordingly, we do not expect to record service revenues for the remainder of 2014 and beyond.

Product Costs

The following table provides information with respect to our product costs and product margins for the six months ended June 30, 2014 and 2013:

 

     Six Months Ended June 30,        
           2014               2013         %
Increase
  (Decrease)  
 
     (in thousands)        

Product costs

   $ 529      $ 633        (16 %) 

Product gross margin

     66     65     1

Product costs decreased by 16%, or $104,000, to $529,000 in the six months ended June 30, 2014 as compared to $633,000 in the six months ended June 30, 2013. The decrease in product costs was commensurate with the decrease in product revenue.

Service Costs

The following table provides information with respect to our service costs for the six months ended June 30, 2014 and 2013:

 

     Six Months Ended June 30,         
             2014                      2013              %
  Decrease  
 
     (in thousands)         

Service costs

   $  —        $ 102         (100 %) 

Service costs decreased by 100%, or $102,000, to $0 in the six months ended June 30, 2014 as compared to $102,000 in the six months ended June 30, 2013. Service costs in the six months ended June 30, 2013 consisted of costs related to the High Risk Plaque initiative program. There are no further costs to incur under this project. Accordingly, we do not expect to record service costs for the remainder of 2014 and beyond.

Operating Expenses

The following table summarizes our operating expenses for the six months ended June 30, 2014 and 2013:

 

     Six Months Ended June 30,         
             2014                      2013              %
  Decrease  
 
     (in thousands)         

Operating expenses

        

Research and development

   $ 1,133       $ 2,493         (55 %) 

Selling and marketing

     1,421         3,926         (64 %) 

General and administrative

     2,373         4,090         (42 %) 
  

 

 

    

 

 

    

Total operating expenses

   $ 4,927       $ 10,509         (53 %) 
  

 

 

    

 

 

    

 

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Research and development

Research and development expenses decreased by 55%, or $1.4 million, to $1.1 million in the six months ended June 30, 2014 as compared to $2.5 million in the six months ended June 30, 2013. The decrease in research and development expenses for the current period over the prior period was primarily attributable to a decrease in professional service costs by $504,000, a decrease in biomarker discovery research costs by $489,000, a decrease in costs related to the CardioSCORE medical review and adjudication process by $446,000, and a decrease in product development costs associated with CardioSCORE and the automated platform of $71,000. These decreases were offset by a cost sharing arrangement with one of our automated partners in the amount of $150,000 in 2013.

Selling and marketing

Selling and marketing expenses decreased by 64%, or $2.5 million, to $1.4 million in the six months ended June 30, 2014 as compared to $3.9 million in the six months ended June 30, 2013. The decreased expenditures were primarily due to costs related to refocusing our marketing activities from market education to commercialization of $1.4 million and a decrease in compensation related costs and travel of $916,000.

General and administrative

General and administrative expenses decreased by 42%, or $1.7 million, to $2.4 million in the six months ended June 30, 2014 as compared to $4.1 million in the six months ended June 30, 2013. This decrease is due primarily to a decrease in compensation related charges and travel of $1.2 million and decreased legal and audit related fees of $418,000.

Other income and expense

The following table summarizes other (expense) income for the six months ended June 30, 2014 and 2013:

 

     Six Months Ended June 30,        
             2014                     2013             %
  Decrease  
 
     (in thousands)        

Other (expense) income

      

Non-cash consideration associated with stock purchase agreement

   $ —       $ (329     (100 %) 

Interest income/other (expense) income

     2        14        (86 %) 

Interest expense

     (432     (584     (26 %) 
  

 

 

   

 

 

   

Total other (expense) income

   $ (430   $ (899     (52 %) 
  

 

 

   

 

 

   

Other (expense) income decreased by $469,000 resulting primarily from the non-cash commitment fee required by our common stock purchase agreement with Aspire Capital Fund, LLC that we paid during the six months ended June 30, 2013 for which we had no corresponding expense during the six months ended June 30, 2014, and less interest expense due to lower loan balances on our term loan because of our principal payments.

Liquidity and Capital Resources

Sources of Liquidity

Our primary sources of liquidity have included our cash balances, sales of our equity securities, term loan, product revenue from sales of the BGM Galectin-3 Test, and service revenue from the HRP initiative. As of June 30, 2014, we had $9.5 million of cash.

 

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Follow-on Underwritten Public Offerings

On January 30, 2013, we closed a follow-on underwritten public offering of 6,900,000 shares of our common stock, which included the sale of 900,000 shares pursuant to the underwriters’ over-allotment option. The net offering proceeds that we received, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $12.8 million.

On April 8, 2014, we closed a follow-on underwritten public offering of 6,452,000 shares of our common stock, at an offering price of $1.55 per share, for gross proceeds of $10.0 million. The net offering proceeds that we received, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million.

Common Stock Purchase Agreement with Aspire

On January 24, 2013, we entered into a Common Stock Purchase Agreement, or the Purchase Agreement, with Aspire Capital Fund, LLC, or Aspire, to purchase, at our option, up to an aggregate of $12.0 million of shares of our common stock over a two-year term, which expires in May 2015. Under the Purchase Agreement, we initially issued 132,743 shares of our common stock as a commitment fee. Our sales to Aspire will be made subject to market conditions, in light of our capital needs and under various limitations contained in the Purchase Agreement. We have not yet sold any shares under the Purchase Agreement.

Over the term of the Purchase Agreement, assuming the Company’s common stock is trading above the $1.00 minimum floor price that is required to use the facility, we have two ways to elect to sell common stock to Aspire on any business day we select: (1) through a regular purchase of up to 100,000 shares at prices based on the market price of our common stock prior to the time of each sale, and (2) through a volume weighted average price, or VWAP, purchase of a number of shares up to 30% of the volume traded on the purchase date at a price equal to the lesser of the closing sale price or 95% of the VWAP for such purchase date.

We also entered into a Registration Rights Agreement with Aspire, which requires, among other things, that we maintain the effectiveness of our registration statement that registered the shares issued and issuable to Aspire under the Purchase Agreement.

Secured Term Loan Facility

In February 2012, we entered into a secured term loan facility with General Electric Capital Corporation and Comerica Bank, and a term loan in the aggregate principal amount of $10.0 million was funded to us upon the closing of the transaction. The term loan accrues interest at a rate of 8% per annum plus the higher of (a) the 3-month LIBOR rate or (b) 1.25%. The interest rate in effect at June 30, 2014 was 9.25%. Interest only payments were made for the first twelve months of the loan term. Following that initial twelve month period, principal and interest payments are required to be paid on a monthly basis through maturity at September 2015.

May 2013 Loan Amendment

In May 2013, the loan and security agreement was amended to allow for a three month deferral of principal payments beginning May 1, 2013 and to allow for up to an additional three months of deferral based on us meeting certain minimum liquidity requirements, as defined in the amendment. We made principal payments in March and April 2013 prior to the signing of the amendment. We did not meet the additional liquidity requirements, as defined in the amendment, and, accordingly, principal payments resumed on August 1, 2013. The amendment also increased certain loan fees by $50,000, and amended the terms of the warrants, as discussed below.

Warrants

In connection with the loan facility, we initially issued warrants to purchase 36,657 shares of our common stock with an exercise price of $6.82 per share. The warrants expire ten years from the date of issuance. The warrants were valued using the Black-Scholes option pricing model using the following assumptions: fair value of the underlying common stock of $8.51 per share; volatility of 70%; no dividend yield; risk free interest rate of 1.96%; and an expected life of ten years. The relative fair value of the warrants, aggregating $240,000, has been accounted for as a debt discount and is being recognized as interest expense over the term of the loan using the effective interest method. As part of the May 2013 amendment to the loan and security agreement, the number of shares for which the warrants were exercisable increased by 110,401 shares and the warrant price of the warrants was adjusted to $1.70 per share. At the loan modification date, we valued the warrants using the Black-Scholes option pricing model and recorded the incremental value of the increased number of shares for which the warrants are exercisable as additional debt discount in the amount of $163,000, which is being recognized as additional interest expense over the remaining term of the loan using the effective interest method. The warrants under the term loan have been classified as equity instruments and are included within additional paid-in capital.

 

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At June 30, 2014, we had $5.2 million outstanding under the term loan.

Net Cash Flows

Cash (used in) provided by operating, investing and financing activities for the six months ended June 30, 2014 and 2013 is summarized as follows:

 

     Six Months Ended June 30,  

Summary Cash Flow Information

           2014                     2013                 Change      

Net cash (used in) provided by:

      

Operating activities

   $ (4,992   $ (8,808   $ 3,816   

Investing activities

     —         80        (80

Financing activities

     6,779        12,145        (5,366
  

 

 

   

 

 

   

 

 

 

Net increase in cash

     1,787        3,417        (1,630
  

 

 

   

 

 

   

 

 

 

Cash at end of period

   $ 9,538      $ 16,203      $ (6,665
  

 

 

   

 

 

   

 

 

 

Six Months Ended June 30, 2014 and 2013

Net cash used in operating activities decreased primarily due to a decrease in our net loss and non-cash charges for the six month period ended June 30, 2014 compared to the same period in 2013, partially offset by an increase in changes in working capital related primarily to a large decrease in accounts payable, accrued expenses and other current liabilities in the six month period ended June 30, 2013.

Net cash provided by investing activities decreased due to the proceeds received from the sale of laboratory equipment in the six month period ended June 30, 2013 for which we received no similar proceeds in the six month period ended June 30, 2014.

Net cash provided by financing activities decreased due to principal payments under our term loan of $2.2 million in the six month period ended June 30, 2014 and net proceeds of $9.0 million and $12.8 million received from our follow-on public offerings in April 2014 and January 2013, respectively.

Funding Requirements

During the six months ended June 30, 2014, we incurred a net loss of $4.3 million and used $5.0 million of cash in operations, and expect to continue to incur losses and use cash during 2014 and beyond. At June 30, 2014, we had cash totaling $9.5 million, and an outstanding balance of $5.2 million under our secured term loan facility.

Effective January 1, 2014, the payment rate at which our BGM Galectin-3 Test is reimbursed by the Centers for Medicare and Medicaid Services, or CMS, was increased to $30.01 from $17.80 per test. We expect to increase our revenues through higher reimbursement levels and by engaging additional laboratory providers, and expect to decrease our operating expenses. However, we are in the early stages of commercializing our BGM Galectin-3 Test. Interest in the BGM Galectin-3 Test is increasing as a result of our market development activities, although it has not yet translated into significant revenue. In order to achieve profitability, we will need to generate significant product revenues.

Under our arrangement with Aspire, we may require Aspire to purchase up to $12 million of our common stock under the Purchase Agreement, subject to the conditions and limitations contained therein, including a floor price of $1.00 per share. Through July 31, 2014, our closing stock price has ranged from a high of $2.08 to a low of $0.89. If in the future, the closing price of our common stock falls below the $1.00 floor price, we would not have access to this facility. We have not yet sold any shares under the Purchase Agreement, which expires in May 2015.

At June 30, 2014, we have an outstanding balance of $5.2 million under the term loan facility and we are required to repay the principal monthly through maturity in September 2015. Our term loan is secured by substantially all of our assets. Our loan and security agreement contains customary events of default that entitle the lenders to cause any or all of our indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including our cash. The events of default include, among others, the occurrence of a material adverse effect, which could cause the lender to accelerate the payments by us under the term loan. We have determined that the risk of a subjective acceleration under the material adverse effect clause, absent acceleration under other enumerated events of default, is remote.

 

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Until we have repaid all amounts due to the lenders under this term loan facility, our ability to raise additional funds through other debt financings is limited.

We believe that our existing cash and availability of up to $12.0 million under our Purchase Agreement with Aspire, pursuant to which approximately $4.1 million would have been available to the Company through the sale of available shares over the purchase period ending June 30, 2014, will be sufficient to fund our operations and service our debt into the second quarter of 2015. We have not yet sold any shares under our Purchase Agreement with Aspire, which expires in May 2015. Until we generate significant product revenues to reach cash breakeven, we will need to raise additional funds to finance our operations and service our existing debt beyond the second quarter of 2015. We may not be able to obtain adequate financing to do so when necessary, and the terms of any financings may not be advantageous to us and any financings may result in dilution to our stockholders.

The above circumstances along with our history and near term forecast of incurring net losses and negative operating cash flows raise substantial doubt regarding our ability to continue as a going concern beyond the second quarter of 2015. The accompanying condensed consolidated financial statements have been prepared assuming we will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to our ability to continue as a going concern.

Our forecast of the period of time through which our financial resources will be adequate to support our operations and; the cost to develop and commercialize our products are forward-looking statements and involve risks and uncertainties, and actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in the “Risk Factors” section of this report and in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2013. We have based these estimates on assumptions that may prove to be incorrect, and we could utilize our available capital resources sooner than we currently expect.

Our future liquidity and capital funding requirements will depend on numerous factors, including:

 

    the revenue generated by sales of our cardiovascular diagnostic tests;

 

    the rate of progress and cost of our commercialization activities;

 

    the outcome, costs and timing of seeking regulatory clearance for our product candidates and for additional indications for existing products;

 

    the success of our development efforts;

 

    the expenses we incur in marketing and selling our products;

 

    the emergence and effect of competing or complementary products;

 

    our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights;

 

    our need and ability to hire additional management and scientific and medical personnel;

 

    our need to implement additional internal systems and infrastructure, including financial and reporting systems;

 

    the terms and timing of any collaborative, licensing or other arrangements that we have or may establish;

 

    our ability to raise additional funds to finance our operations and service our debt;

 

    the trading price of our common stock being above the $1.00 minimum floor price that is required for us to use the Purchase Agreement with Aspire;

 

    the trading price of our common stock; and

 

    our ability to maintain compliance with the continued listing requirements of The NASDAQ Capital Market.

Contractual Obligations and Commitments

There have been no material changes to our contractual obligations and commitments set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments” in our Annual Report on Form 10-K for the year ended December 31, 2013.

 

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Critical Accounting Policies and Significant Judgments and Estimates

A summary of our significant accounting policies is contained in the notes to our consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2013. There have been no material changes to those policies during the six months ended June 30, 2014.

Certain Factors That May Affect Future Results of Operations

The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. This Quarterly Report on Form 10-Q contains such “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other important factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

 

    our estimates of future performance, including the commercialization and sales of our galectin-3 test;

 

    our ability to provide sufficient evidence of clinical utility for our galectin-3 test and to differentiate it from competing cardiovascular diagnostics tests;

 

    our ability to obtain regulatory clearance from the FDA for our CardioSCORE test and certain additional indications for our galectin-3 test;

 

    our ability to successfully market, commercialize and achieve widespread market penetration for our cardiovascular diagnostic tests;

 

    our ability to diversify our customer base due to our current dependence upon a certain few, and one primary, laboratory provider customer;

 

    our ability to conduct the clinical studies required for regulatory clearance or approval and to demonstrate the clinical benefits and cost-effectiveness to support commercial acceptance of our products;

 

    the timing, costs and other limitations involved in obtaining regulatory clearance or approval for any of our products;

 

    the potential benefits of our cardiovascular diagnostic tests over current medical practices or other diagnostics;

 

    willingness of third-party payers to reimburse for the cost of our tests;

 

    the ability of our automated partners to develop and obtain regulatory clearance of galectin-3 tests that can be performed on their automated platforms and to commercialize any such tests;

 

    the ability of the automation of the galectin-3 test to broaden its acceptance by laboratory customers and accelerate its clinical adoption;

 

    our beliefs about the potential clinical and commercial value of the galectin-3 test beyond its current indications for use;

 

    the potential to move forward with a European launch of CardioSCORE in test markets;

 

    our beliefs about the value of data generated from the BioImage Study;

 

    estimates of market sizes and anticipated uses of our cardiovascular diagnostic tests;

 

    our ability to enter into collaboration and distribution agreements with respect to our cardiovascular diagnostic tests, the performance of our partners under such agreements and the potential benefits of these arrangements;

 

    our ability to obtain and maintain intellectual property protections for our products and operate our business without infringing upon the intellectual property rights of others;

 

    the expected timing, progress or success of our development and commercialization efforts;

 

    our ability to successfully obtain sufficient and appropriate blood samples for our validation tests in support of our regulatory filings for our cardiovascular tests;

 

    our ability to continue as a going concern;

 

    our ability to obtain additional financing on terms acceptable to us;

 

    our expectations regarding the use of our Purchase Agreement with Aspire to obtain additional capital through sales of our common stock to Aspire;

 

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    our ability to maintain compliance with the continued listing requirements of The NASDAQ Capital Market;

 

    the success of competing cardiovascular diagnostic tests that are or become available;

 

    regulatory developments in the United States and other countries in which we sell or plan to sell our tests;

 

    the performance of our third-party suppliers and the manufacturer of our galectin-3 tests, due to our reliance upon a single third party to manufacture and supply our products;

 

    our ability to service the principal and interest amounts payable under our secured term loan facility; and

 

    our estimates regarding anticipated operating losses, future revenue, expenses, capital requirements and our needs for additional financing.

Words such as “may,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to those set forth under the heading “Risk Factors” contained in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2013 as supplemented by the risk factors discussed under “Risk Factors” in Part II, Item 1A. of this Quarterly Report on Form 10-Q.

In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report on Form 10-Q or in any document incorporated herein by reference might not occur. Stockholders are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to BG Medicine, Inc. or to any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.

 

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There have been no material changes from the information provided in our Annual Report on Form 10-K for the year ended December 31, 2013, except as noted below:

Currency Exchange Rates

We have limited foreign currency exchange rate risk. The effect of an immediate 10% change in current foreign currency exchange rates would not have a material impact on our financial condition, results of operations or cash flows.

 

Item 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures. Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

(b) Changes in Internal Controls. There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control that occurred during the quarter ended June 30, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

On May 14, 2013, the Committee of Sponsoring Organizations of the Treadway Commission (COSO) issued an updated version of its Internal Control - Integrated Framework (2013 Framework). Originally issued in 1992 (1992 Framework), the framework helps organizations design, implement and evaluate the effectiveness of internal control concepts and simplify their use and application. The 1992 Framework remains available during the transition period, which extends to December 15, 2014, after which time COSO will consider it as superseded by the 2013 Framework. As of June 30, 2014, the Company continues to utilize the 1992 Framework during the transition to the 2013 Framework by the end of 2014.

 

21


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PART II: OTHER INFORMATION

 

Item 1. LEGAL PROCEEDINGS

We are not currently a party to any material legal proceedings.

 

Item 1A. RISK FACTORS

There have been no material changes to the risk factors discussed in Item 1A. Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2013.

 

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Unregistered Sales of Equity Securities

Not applicable.

Issuer Purchases of Equity Securities

We did not repurchase any of our equity securities during the quarter ended June 30, 2014.

 

Item 3. DEFAULTS UPON SENIOR SECURITIES

Not applicable.

 

Item 4. MINE SAFETY DISCLOSURES

Not applicable.

 

Item 5. OTHER INFORMATION

Not applicable.

 

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Item 6. EXHIBITS

 

Exhibit
Number

  

Exhibit Description

  

Filed

with

this

Report

  

Incorporated

by

Reference

herein

from Form

or

Schedule

  

Filing

Date

  

SEC File/

Reg. Number

  31.1    Certification of the Registrant’s Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002    X         
  31.2    Certification of the Registrant’s Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002    X         
  32    Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002    X         
101    The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, formatted in XBRL (eXtensible Business Reporting Language): (i) Unaudited Condensed Consolidated Balance Sheets as of June 30, 2014 and December 31, 2013, (ii) Unaudited Condensed Consolidated Statements of Operations for the three and six month periods ended June 30, 2014 and 2013, (iii) Unaudited Condensed Consolidated Statements of Cash Flows for the six month periods ended June 30, 2014 and 2013, and (iv) Notes to Unaudited Condensed Consolidated Financial Statements    X         

 

23


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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.

 

    BG MEDICINE, INC.
Date: August 14, 2014     By:  

/s/ Paul R. Sohmer

      Paul R. Sohmer, M.D.
      President and Chief Executive Officer
Date: August 14, 2014     By:  

/s/ Stephen P. Hall

      Stephen P. Hall
      Executive Vice President, Chief Financial Officer and Treasurer
EX-31.1 2 d752642dex311.htm EX-31.1 EX-31.1

Exhibit 31.1

CERTIFICATIONS UNDER SECTION 302

I, Paul R. Sohmer, certify that:

1. I have reviewed this quarterly report on Form 10-Q of BG Medicine, 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. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

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. The registrant’s other certifying officer(s) and I have disclosed, based on our 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 14, 2014

 

/s/ Paul R. Sohmer

Paul R. Sohmer, M.D.
President and Chief Executive Officer
(principal executive officer)
EX-31.2 3 d752642dex312.htm EX-31.2 EX-31.2

Exhibit 31.2

CERTIFICATIONS UNDER SECTION 302

I, Stephen P. Hall, certify that:

1. I have reviewed this quarterly report on Form 10-Q of BG Medicine, 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. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

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. The registrant’s other certifying officer(s) and I have disclosed, based on our 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 14, 2014

 

/s/ Stephen P. Hall

Stephen P. Hall

Executive Vice President, Chief Financial Officer and Treasurer

(principal financial officer)

EX-32 4 d752642dex32.htm EX-32 EX-32

Exhibit 32

CERTIFICATIONS UNDER SECTION 906

Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of BG Medicine, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge, that:

The Quarterly Report for the quarter ended June 30, 2014 (the “Form 10-Q”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: August 14, 2014    

/s/ Paul R. Sohmer

    Paul R. Sohmer, M.D.
    President and Chief Executive Officer
    (principal executive officer)
Dated: August 14, 2014    

/s/ Stephen P. Hall

    Stephen P. Hall
   

Executive Vice President, Chief Financial Officer and Treasurer

(principal financial officer)

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The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> The Company does not currently provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Service Revenues</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Service revenues are primarily attributable to the activities from the High Risk Plaque initiative, for which all revenue has been recorded as of December&#xA0;31, 2013. The Company does not expect to record service revenues in 2014 or beyond.</p> </div> -4992000 <div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Inventories consisted of the following:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="76%" align="center" border="0"> <tr> <td width="64%"></td> <td valign="bottom" width="15%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="15%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom"><b>(in thousands)</b></td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"> <b>&#xA0;&#xA0;&#xA0;&#xA0;June&#xA0;30,&#xA0;2014&#xA0;&#xA0;&#xA0;&#xA0;</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>December&#xA0;31,&#xA0;2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Raw materials</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">86</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">107</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Finished goods</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">468</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">352</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td>&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td>&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 3em; TEXT-INDENT: -1em"> Total inventories</p> </td> <td valign="bottom"><font style="FONT-SIZE: 8pt">&#xA0;&#xA0;</font></td> <td valign="bottom">$</td> <td valign="bottom" align="right">554</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom"><font style="FONT-SIZE: 8pt">&#xA0;&#xA0;</font></td> <td valign="bottom">$</td> <td valign="bottom" align="right">459</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td>&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td>&#xA0;</td> </tr> </table> </div> <div> <table style="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" border="0" cellpadding="0" cellspacing="0" width="100%"> <tr> <td width="4%" valign="top" align="left"><b>3.</b></td> <td align="left" valign="top"><b>Fair Value of Financial Instruments</b></td> </tr> </table> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> At June&#xA0;30, 2014, the Company&#x2019;s financial instruments consist of cash, accounts receivable, accounts payable and debt. The carrying amounts of accounts receivable, accounts payable and short-term debt are considered reasonable estimates of their fair value, due to the short maturity of these instruments. The carrying amount of the long term debt was considered a reasonable estimate of fair value because the Company&#x2019;s effective interest rate is near current market rates for instruments with similar characteristics.</p> </div> 30942514 <div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 0pt"> The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June&#xA0;30, 2014 and 2013:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="92%" align="center" border="0"> <tr> <td width="55%"></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"> <b>Three&#xA0;Months&#xA0;Ended&#xA0;June 30,</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"><b>Six&#xA0;Months&#xA0;Ended&#xA0;June 30,</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom" colspan="14" align="center"> <b>(in&#xA0;thousands,&#xA0;except&#xA0;share&#xA0;and&#xA0;per&#xA0;share&#xA0;data)</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Net loss</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(2,169</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(4,837</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(4,348</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(10,249</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Weighted average number of shares - basic and diluted</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">33,915,465</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">27,649,879</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">30,942,514</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">26,490,682</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Net loss per share - basic and diluted</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.06</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.18</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.14</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.39</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> </tr> </table> </div> <div> <table style="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" border="0" cellpadding="0" cellspacing="0" width="100%"> <tr> <td width="4%" valign="top" align="left"><b>4.</b></td> <td align="left" valign="top"><b>Term Loan</b></td> </tr> </table> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> On February&#xA0;10, 2012, the Company entered into a secured term loan facility, and a term loan in the aggregate principal amount of $10.0 million was funded upon the closing of the transaction.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> The term loan accrues interest at a rate of 8%&#xA0;per annum plus the higher of (a)&#xA0;the 3-month LIBOR rate or (b)&#xA0;1.25%. The interest rate in effect at June&#xA0;30, 2014 was 9.25%. Interest only payments were made for the first twelve months of the loan term. Following that initial twelve month period, principal and interest payments are required to be paid on a monthly basis through maturity at September 2015. The term loan is secured by substantially all of the Company&#x2019;s assets, other than its intellectual property, for which the Company has provided a negative pledge. The loan and security agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, covenants that limit or restrict the Company&#x2019;s ability to incur indebtedness, merge or consolidate, dispose of assets, make acquisitions, pay dividends or make distributions, or repurchase stock. In addition, the loan and security agreement contains customary events of default that entitle the lenders to cause any or all of the Company&#x2019;s indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including the Company&#x2019;s cash. The events of default include, among others, non-payment of principal and interest when due, inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency and the occurrence of a material adverse effect (as defined in the loan and security agreement).</p> <p style="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> <b><i>May 2013 Loan Amendment</i></b></p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> In May 2013, the Company amended its loan and security agreement to allow for a three month deferral of principal payments beginning May&#xA0;1, 2013 and to allow for up to an additional three months of deferral based on the Company meeting certain minimum liquidity requirements, as defined in the amendment. The Company made principal payments in March and April 2013 prior to the signing of the amendment. The Company did not meet the additional liquidity requirements, as defined in the amendment, and, accordingly, principal payments resumed on August&#xA0;1, 2013. The amendment also increased certain loan fees by $50,000, and amended the terms of the warrants, as discussed below.</p> <p style="font-size:1px;margin-top:18px;margin-bottom:0px"> &#xA0;</p> <p style="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> <b><i>Warrants</i></b></p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> In connection with the loan facility, the Company initially issued to the lenders warrants to purchase 36,657 shares of its common stock with an exercise price of $6.82 per share. The warrants expire ten years from the date of issuance. The warrants were valued using the Black-Scholes option pricing model using the following assumptions: fair value of the underlying common stock of $8.51 per share; volatility of 70%; no dividend yield; risk free interest rate of 1.96%; and an expected life of ten years. The relative fair value of the warrants, aggregating $240,000, has been accounted for as a debt discount and is being recognized as interest expense over the term of the loan using the effective interest method. These warrants have been classified as equity instruments&#xA0;and are included within additional paid-in capital. As part of the May 2013 amendment to the loan and security agreement, the number of shares for which the warrants were exercisable increased by 110,401 shares and the exercise price of the warrants was adjusted to $1.70 per share. At the loan modification date, the Company valued the warrants using the Black-Scholes option pricing model and recorded the incremental value of the increased number of shares for which the warrants are exercisable as additional debt discount in the amount of $163,000, which is being recognized as additional interest expense over the remaining term of the loan using the effective interest method.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> At June&#xA0;30, 2014, the Company had $5.2 million outstanding under the term loan.</p> </div> <div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Inventory</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Inventory is stated at the lower of cost or market.&#xA0;Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="76%" align="center" border="0"> <tr> <td width="64%"></td> <td valign="bottom" width="15%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="15%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom"><b>(in thousands)</b></td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"> <b>&#xA0;&#xA0;&#xA0;&#xA0;June&#xA0;30,&#xA0;2014&#xA0;&#xA0;&#xA0;&#xA0;</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>December&#xA0;31,&#xA0;2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Raw materials</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">86</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">107</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Finished goods</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">468</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">352</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td>&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td>&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 3em; TEXT-INDENT: -1em"> Total inventories</p> </td> <td valign="bottom"><font style="FONT-SIZE: 8pt">&#xA0;&#xA0;</font></td> <td valign="bottom">$</td> <td valign="bottom" align="right">554</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom"><font style="FONT-SIZE: 8pt">&#xA0;&#xA0;</font></td> <td valign="bottom">$</td> <td valign="bottom" align="right">459</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td>&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td>&#xA0;</td> </tr> </table> </div> <div> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <td valign="top" width="4%" align="left"><b>2.</b></td> <td valign="top" align="left"><b>Significant Accounting Policies</b></td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> <b>Product Revenues</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Product revenues are recognized when the following criteria have been met: (i)&#xA0;persuasive evidence of an arrangement exists; (ii)&#xA0;delivery has occurred and risk of loss has passed; (iii)&#xA0;the seller&#x2019;s price to the buyer is fixed or determinable; and (iv)&#xA0;collectability is reasonably assured.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> The Company sells its products through supply agreements with laboratory testing services and diagnostic testing distributors and directly to hospitals and clinics. The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> The Company does not currently provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Service Revenues</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Service revenues are primarily attributable to the activities from the High Risk Plaque initiative, for which all revenue has been recorded as of December&#xA0;31, 2013. The Company does not expect to record service revenues in 2014 or beyond.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Inventory</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Inventory is stated at the lower of cost or market.&#xA0;Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="76%" align="center" border="0"> <tr> <td width="64%"></td> <td valign="bottom" width="15%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="15%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom"><b>(in thousands)</b></td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"> <b>&#xA0;&#xA0;&#xA0;&#xA0;June&#xA0;30,&#xA0;2014&#xA0;&#xA0;&#xA0;&#xA0;</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>December&#xA0;31,&#xA0;2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Raw materials</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">86</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">107</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Finished goods</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">468</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">352</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td>&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 1px solid">&#xA0;</p> </td> <td>&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 3em; TEXT-INDENT: -1em"> Total inventories</p> </td> <td valign="bottom"><font style="FONT-SIZE: 8pt">&#xA0;&#xA0;</font></td> <td valign="bottom">$</td> <td valign="bottom" align="right">554</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom"><font style="FONT-SIZE: 8pt">&#xA0;&#xA0;</font></td> <td valign="bottom">$</td> <td valign="bottom" align="right">459</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 1px"> <td valign="bottom"></td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td>&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td valign="bottom"> <p style="BORDER-TOP: #000000 3px double">&#xA0;</p> </td> <td>&#xA0;</td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Net Loss Per Share</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Basic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented.</p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 6px"> &#xA0;</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 0pt"> The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June&#xA0;30, 2014 and 2013:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="92%" align="center" border="0"> <tr> <td width="55%"></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"> <b>Three&#xA0;Months&#xA0;Ended&#xA0;June 30,</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"><b>Six&#xA0;Months&#xA0;Ended&#xA0;June 30,</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom" colspan="14" align="center"> <b>(in&#xA0;thousands,&#xA0;except&#xA0;share&#xA0;and&#xA0;per&#xA0;share&#xA0;data)</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Net loss</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(2,169</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(4,837</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(4,348</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(10,249</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Weighted average number of shares - basic and diluted</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">33,915,465</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">27,649,879</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">30,942,514</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">26,490,682</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Net loss per share - basic and diluted</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.06</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.18</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.14</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.39</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> For the three and six months ended June&#xA0;30, 2014 and 2013, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="76%" align="center" border="0"> <tr> <td width="76%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"> <b>Three&#xA0;and&#xA0;Six&#xA0;Months&#xA0;Ended&#xA0;June&#xA0;30,</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Options to purchase common stock</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">3,042,661</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">2,913,192</td> <td valign="bottom" nowrap="nowrap">&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Warrants to purchase common stock</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">864,555</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">864,555</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> </table> </div> <div> <table style="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" border="0" cellpadding="0" cellspacing="0" width="100%"> <tr> <td width="4%" valign="top" align="left"><b>1.</b></td> <td align="left" valign="top"><b>Description of Business and Basis of Presentation</b></td> </tr> </table> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> <b>Description of Business</b></p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> BG Medicine, Inc. (&#x201C;BG Medicine&#x201D; or the &#x201C;Company&#x201D;) is a commercial stage company that is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. The Company has one diagnostic test that is U.S. Food and Drug Administration, or FDA, cleared and CE marked, the BGM Galectin-3<sup style="font-size:85%; vertical-align:top">&#xAE;</sup> Test, an <i>in vitro</i> diagnostic device that quantitatively measures galectin-3 levels in blood plasma or serum for use as an aid in assessing the prognosis of chronic heart failure. It is currently available as a blood test in the United States and the European Union, or EU. The Company is also developing a pipeline of diagnostic products including the CardioSCORE&#x2122; Test, a biomarker-based blood test designed as an aid in the assessment of near-term risk for significant cardiovascular events, such as heart attack and stroke.</p> <p style="margin-top:18pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> <b>Basis of Presentation</b></p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States and in accordance with the rules and regulations of the Securities and Exchange Commission (&#x201C;SEC&#x201D;) for interim financial information.&#xA0;Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements.&#xA0;The interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company&#x2019;s financial position at June&#xA0;30, 2014 and results of operations and cash flows for the interim periods ended June&#xA0;30, 2014 and 2013.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates and to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. The results for the six months ended June&#xA0;30, 2014 are not necessarily indicative of the results to be expected for the year ending December&#xA0;31, 2014 or for any other interim period or for any other future year. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company&#x2019;s Annual Report on <font style="white-space:nowrap">Form&#xA0;10-K</font> for the year ended December&#xA0;31, 2013.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> At June&#xA0;30, 2014, the Company had cash totaling $9.5 million, an outstanding balance of $5.2 million under a secured term loan facility, and stockholder&#x2019;s equity of $4.0 million. During the six months ended June&#xA0;30, 2014, the Company incurred a net loss of $4.3 million and used cash in operating activities totaling $5.0 million. The Company expects to continue to incur losses and use cash in operating activities during the remainder of 2014 and beyond.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> On April&#xA0;8, 2014, the Company closed a follow-on underwritten public offering of 6,452,000 shares of its common stock, at an offering price of $1.55 per share, for gross proceeds of $10.0 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> Effective January&#xA0;1, 2014, the payment rate at which the Company&#x2019;s BGM Galectin-3 Test is reimbursed by the Centers for Medicare and Medicaid Services (&#x201C;CMS&#x201D;), was increased to $30.01 from $17.80 per test. The Company expects to increase its revenues through higher reimbursement levels and by engaging additional laboratory providers and expects to decrease its operating expenses. However, the Company is in the early stages of commercializing its BGM Galectin-3 Test. Interest in the BGM Galectin-3 Test is increasing as a result of the Company&#x2019;s market development activities, although it has not yet translated into significant revenue. In order to achieve profitability, the Company will need to generate significant product revenues.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> As further described in Note 4, the Company&#x2019;s term loan is secured by substantially all of the Company&#x2019;s assets. The loan and security agreement contains customary events of default that entitle the lenders to cause any or all of the Company&#x2019;s indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including the Company&#x2019;s cash. The events of default include, among others, the occurrence of a material adverse effect which could cause the lender to accelerate the payments by the Company under the term loan. The Company has determined that the risk of a subjective acceleration under the material adverse effect clause, absent acceleration under other enumerated events of default, is remote.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> The Company believes that its existing cash and availability of up to $12.0 million under its common stock purchase agreement with Aspire Capital Fund, LLC (&#x201C;Aspire&#x201D;), (Note 6) pursuant to which approximately $4.1 million would have been available to the Company through the sale of available shares over the purchase period ending June&#xA0;30, 2014, will be sufficient to fund its operations and service its debt into the second quarter of 2015. The Company has not yet sold any shares under its common stock purchase agreement with Aspire, which expires in May 2015. In order for the Company to sell shares to Aspire under the Purchase Agreement, the Company&#x2019;s common stock must trade above the $1.00 minimum floor price set forth in the Purchase Agreement. Until the Company generates significant product revenues to reach cash breakeven, the Company will need to raise additional funds to finance its operations and service its existing debt beyond the second quarter of 2015. The Company may not be able to obtain adequate financing to do so when necessary, and the terms of any financings may not be advantageous to it.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> The above circumstances along with the Company&#x2019;s history and near term forecast of incurring net losses and negative operating cash flows raise substantial doubt regarding its ability to continue as a going concern beyond the second quarter of 2015. The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.</p> </div> <div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 18pt"> <b>Net Loss Per Share</b></p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> Basic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented.</p> <p style="MARGIN-BOTTOM: 0px; FONT-SIZE: 1px; MARGIN-TOP: 6px"> &#xA0;</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 0pt"> The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June&#xA0;30, 2014 and 2013:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="92%" align="center" border="0"> <tr> <td width="55%"></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="6%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"> <b>Three&#xA0;Months&#xA0;Ended&#xA0;June 30,</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"><b>Six&#xA0;Months&#xA0;Ended&#xA0;June 30,</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom" colspan="14" align="center"> <b>(in&#xA0;thousands,&#xA0;except&#xA0;share&#xA0;and&#xA0;per&#xA0;share&#xA0;data)</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 1pt"> <td height="8"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> <td height="8" colspan="4"></td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Net loss</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(2,169</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(4,837</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(4,348</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(10,249</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Weighted average number of shares - basic and diluted</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">33,915,465</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">27,649,879</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">30,942,514</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom" align="right">26,490,682</td> <td valign="bottom" nowrap="nowrap">&#xA0;&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman" bgcolor="#CCEEFF"> <td valign="top"> <p style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 1em; TEXT-INDENT: -1em"> Net loss per share - basic and diluted</p> </td> <td valign="bottom">&#xA0;&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.06</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.18</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.14</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> <td valign="bottom">&#xA0;</td> <td valign="bottom">$</td> <td valign="bottom" align="right">(0.39</td> <td valign="bottom" nowrap="nowrap">)&#xA0;</td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> For the three and six months ended June&#xA0;30, 2014 and 2013, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 12pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="76%" align="center" border="0"> <tr> <td width="76%"></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> <td valign="bottom" width="3%"></td> <td></td> <td></td> <td></td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="6" align="center"> <b>Three&#xA0;and&#xA0;Six&#xA0;Months&#xA0;Ended&#xA0;June&#xA0;30,</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 8pt; FONT-FAMILY: Times New Roman"> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2014</b></td> <td valign="bottom">&#xA0;</td> <td valign="bottom">&#xA0;&#xA0;</td> <td style="BORDER-BOTTOM: #000000 1pt solid" valign="bottom" colspan="2" align="center"><b>2013</b></td> <td valign="bottom">&#xA0;</td> </tr> <tr style="FONT-SIZE: 10pt; 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In April 2014, the Company settled this matter for an amount that had been accrued at December&#xA0;31, 2013. No further losses are expected related to this matter. No other amounts related to contingencies are accrued at June&#xA0;30, 2014.</p> </div> 2000 1538000 2240000 319000 243000 34000 1538000 38000 -3918000 -4348000 95000 1787000 529000 6779000 2373000 116000 380000 1421000 27000 432000 9238000 22000 67000 2000 1133000 -1067000 5456000 <div> <table style="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" border="0" cellpadding="0" cellspacing="0" width="100%"> <tr> <td width="4%" valign="top" align="left"><b>6.</b></td> <td align="left" valign="top"><b>Common Stock Purchase Agreement</b></td> </tr> </table> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> On January&#xA0;24, 2013, the Company entered into a Common Stock Purchase Agreement (&#x201C;Purchase Agreement&#x201D;), with Aspire Capital Fund, LLC to purchase, at the Company&#x2019;s option, up to an aggregate of $12.0 million of shares of its common stock over a two-year term, which expires in May 2015. Under the Purchase Agreement, the Company initially issued 132,743 shares of its common stock as a commitment fee. The Company&#x2019;s sales to Aspire will be made subject to market conditions, in light of its capital needs and under various limitations contained in the Purchase Agreement, including a floor price of $1.00 per share required by the Purchase Agreement. The Company has not yet sold any shares under the Purchase Agreement, which expires in May 2015.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> Over the term of the Purchase Agreement, assuming the Company&#x2019;s common stock is trading above the $1.00 floor price that is required to use the facility, the Company has two ways to elect to sell common stock to Aspire on any business day the Company selects: (1)&#xA0;through a regular purchase of up to 100,000 shares at prices based on the market price of the Company&#x2019;s common stock prior to the time of each sale, and (2)&#xA0;through a volume weighted average price (&#x201C;VWAP&#x201D;), purchase of a number of shares up to 30% of the volume traded on the purchase date at a price equal to the lesser of the closing sale price or 95% of the VWAP for such purchase date.</p> <p style="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"> The Company also entered into a Registration Rights Agreement with Aspire, which requires, among other things, that the Company maintain the effectiveness of the Company&#x2019;s registration statement that registered the shares issued and issuable to Aspire under the Purchase Agreement.</p> </div> <div> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <td valign="top" width="4%" align="left"><b>7.</b></td> <td valign="top" align="left"><b>Follow-on Public Offerings</b></td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-LEFT: 4%; MARGIN-TOP: 6pt"> On January&#xA0;30, 2013, the Company closed a follow-on underwritten public offering of 6,900,000 shares of its common stock, at an offering price of $2.00 per share, for gross proceeds of $13.8 million. 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Term Loan
6 Months Ended
Jun. 30, 2014
Term Loan
4. Term Loan

On February 10, 2012, the Company entered into a secured term loan facility, and a term loan in the aggregate principal amount of $10.0 million was funded upon the closing of the transaction.

The term loan accrues interest at a rate of 8% per annum plus the higher of (a) the 3-month LIBOR rate or (b) 1.25%. The interest rate in effect at June 30, 2014 was 9.25%. Interest only payments were made for the first twelve months of the loan term. Following that initial twelve month period, principal and interest payments are required to be paid on a monthly basis through maturity at September 2015. The term loan is secured by substantially all of the Company’s assets, other than its intellectual property, for which the Company has provided a negative pledge. The loan and security agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to incur indebtedness, merge or consolidate, dispose of assets, make acquisitions, pay dividends or make distributions, or repurchase stock. In addition, the loan and security agreement contains customary events of default that entitle the lenders to cause any or all of the Company’s indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including the Company’s cash. The events of default include, among others, non-payment of principal and interest when due, inaccuracy of representations and warranties, covenant defaults, bankruptcy and insolvency and the occurrence of a material adverse effect (as defined in the loan and security agreement).

May 2013 Loan Amendment

In May 2013, the Company amended its loan and security agreement to allow for a three month deferral of principal payments beginning May 1, 2013 and to allow for up to an additional three months of deferral based on the Company meeting certain minimum liquidity requirements, as defined in the amendment. The Company made principal payments in March and April 2013 prior to the signing of the amendment. The Company did not meet the additional liquidity requirements, as defined in the amendment, and, accordingly, principal payments resumed on August 1, 2013. The amendment also increased certain loan fees by $50,000, and amended the terms of the warrants, as discussed below.

 

Warrants

In connection with the loan facility, the Company initially issued to the lenders warrants to purchase 36,657 shares of its common stock with an exercise price of $6.82 per share. The warrants expire ten years from the date of issuance. The warrants were valued using the Black-Scholes option pricing model using the following assumptions: fair value of the underlying common stock of $8.51 per share; volatility of 70%; no dividend yield; risk free interest rate of 1.96%; and an expected life of ten years. The relative fair value of the warrants, aggregating $240,000, has been accounted for as a debt discount and is being recognized as interest expense over the term of the loan using the effective interest method. These warrants have been classified as equity instruments and are included within additional paid-in capital. As part of the May 2013 amendment to the loan and security agreement, the number of shares for which the warrants were exercisable increased by 110,401 shares and the exercise price of the warrants was adjusted to $1.70 per share. At the loan modification date, the Company valued the warrants using the Black-Scholes option pricing model and recorded the incremental value of the increased number of shares for which the warrants are exercisable as additional debt discount in the amount of $163,000, which is being recognized as additional interest expense over the remaining term of the loan using the effective interest method.

At June 30, 2014, the Company had $5.2 million outstanding under the term loan.

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Fair Value of Financial Instruments
6 Months Ended
Jun. 30, 2014
Fair Value of Financial Instruments
3. Fair Value of Financial Instruments

At June 30, 2014, the Company’s financial instruments consist of cash, accounts receivable, accounts payable and debt. The carrying amounts of accounts receivable, accounts payable and short-term debt are considered reasonable estimates of their fair value, due to the short maturity of these instruments. The carrying amount of the long term debt was considered a reasonable estimate of fair value because the Company’s effective interest rate is near current market rates for instruments with similar characteristics.

XML 16 R2.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Balance Sheets (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2014
Dec. 31, 2013
Current assets    
Cash $ 9,538 $ 7,751
Accounts receivable 353 319
Inventory 554 459
Prepaid expenses and other current assets 352 306
Total current assets 10,797 8,835
Property and equipment, net 154 192
Intangible assets, net 163 192
Deposits and other assets 126 134
Total assets 11,240 9,353
Current liabilities    
Term loan, current portion 4,406 4,353
Accounts payable 1,012 965
Accrued expenses 924 1,993
Other current liabilities 69 39
Total current liabilities 6,411 7,350
Term loan, net of current portion 745 2,961
Other liabilities 102 111
Total liabilities 7,258 10,422
Commitments and contingencies (Note 5)      
Stockholders' equity (deficit)    
Common stock; $.001 par value; 100,000,000 shares authorized at June 30, 2014 and December 31, 2013; 34,417,249 and 27,936,222 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively 34 28
Additional paid-in capital 161,234 151,841
Accumulated deficit (157,286) (152,938)
Total stockholders' equity (deficit) 3,982 (1,069)
Total liabilities and stockholders' equity (deficit) $ 11,240 $ 9,353
XML 17 R6.htm IDEA: XBRL DOCUMENT v2.4.0.8
Description of Business and Basis of Presentation
6 Months Ended
Jun. 30, 2014
Description of Business and Basis of Presentation
1. Description of Business and Basis of Presentation

Description of Business

BG Medicine, Inc. (“BG Medicine” or the “Company”) is a commercial stage company that is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. The Company has one diagnostic test that is U.S. Food and Drug Administration, or FDA, cleared and CE marked, the BGM Galectin-3® Test, an in vitro diagnostic device that quantitatively measures galectin-3 levels in blood plasma or serum for use as an aid in assessing the prognosis of chronic heart failure. It is currently available as a blood test in the United States and the European Union, or EU. The Company is also developing a pipeline of diagnostic products including the CardioSCORE™ Test, a biomarker-based blood test designed as an aid in the assessment of near-term risk for significant cardiovascular events, such as heart attack and stroke.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States and in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles for complete financial statements. The interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position at June 30, 2014 and results of operations and cash flows for the interim periods ended June 30, 2014 and 2013.

The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates and to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements. The results for the six months ended June 30, 2014 are not necessarily indicative of the results to be expected for the year ending December 31, 2014 or for any other interim period or for any other future year. These interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.

At June 30, 2014, the Company had cash totaling $9.5 million, an outstanding balance of $5.2 million under a secured term loan facility, and stockholder’s equity of $4.0 million. During the six months ended June 30, 2014, the Company incurred a net loss of $4.3 million and used cash in operating activities totaling $5.0 million. The Company expects to continue to incur losses and use cash in operating activities during the remainder of 2014 and beyond.

On April 8, 2014, the Company closed a follow-on underwritten public offering of 6,452,000 shares of its common stock, at an offering price of $1.55 per share, for gross proceeds of $10.0 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million.

Effective January 1, 2014, the payment rate at which the Company’s BGM Galectin-3 Test is reimbursed by the Centers for Medicare and Medicaid Services (“CMS”), was increased to $30.01 from $17.80 per test. The Company expects to increase its revenues through higher reimbursement levels and by engaging additional laboratory providers and expects to decrease its operating expenses. However, the Company is in the early stages of commercializing its BGM Galectin-3 Test. Interest in the BGM Galectin-3 Test is increasing as a result of the Company’s market development activities, although it has not yet translated into significant revenue. In order to achieve profitability, the Company will need to generate significant product revenues.

As further described in Note 4, the Company’s term loan is secured by substantially all of the Company’s assets. The loan and security agreement contains customary events of default that entitle the lenders to cause any or all of the Company’s indebtedness under the loan and security agreement to become immediately due and payable and could cause the lenders to foreclose on the collateral securing the indebtedness, including the Company’s cash. The events of default include, among others, the occurrence of a material adverse effect which could cause the lender to accelerate the payments by the Company under the term loan. The Company has determined that the risk of a subjective acceleration under the material adverse effect clause, absent acceleration under other enumerated events of default, is remote.

The Company believes that its existing cash and availability of up to $12.0 million under its common stock purchase agreement with Aspire Capital Fund, LLC (“Aspire”), (Note 6) pursuant to which approximately $4.1 million would have been available to the Company through the sale of available shares over the purchase period ending June 30, 2014, will be sufficient to fund its operations and service its debt into the second quarter of 2015. The Company has not yet sold any shares under its common stock purchase agreement with Aspire, which expires in May 2015. In order for the Company to sell shares to Aspire under the Purchase Agreement, the Company’s common stock must trade above the $1.00 minimum floor price set forth in the Purchase Agreement. Until the Company generates significant product revenues to reach cash breakeven, the Company will need to raise additional funds to finance its operations and service its existing debt beyond the second quarter of 2015. The Company may not be able to obtain adequate financing to do so when necessary, and the terms of any financings may not be advantageous to it.

The above circumstances along with the Company’s history and near term forecast of incurring net losses and negative operating cash flows raise substantial doubt regarding its ability to continue as a going concern beyond the second quarter of 2015. The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.

XML 18 R22.htm IDEA: XBRL DOCUMENT v2.4.0.8
Follow-on Public Offerings - Additional Information (Detail) (Underwritten Public Offering, USD $)
In Millions, except Share data, unless otherwise specified
0 Months Ended
Apr. 08, 2014
Jan. 30, 2013
Apr. 08, 2014
Jan. 30, 2013
Underwritten Public Offering
       
Equity [Line Items]        
Shares of common stock under public offering 6,452,000 6,900,000    
Common stock Offering price     $ 1.55 $ 2.00
Gross proceeds offering $ 10.0 $ 13.8    
Offering proceeds net of underwriting discounts, commissions and expenses $ 9.0 $ 12.8    
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Significant Accounting Policies
6 Months Ended
Jun. 30, 2014
Significant Accounting Policies
2. Significant Accounting Policies

Product Revenues

Product revenues are recognized when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred and risk of loss has passed; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured.

The Company sells its products through supply agreements with laboratory testing services and diagnostic testing distributors and directly to hospitals and clinics. The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price.

Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue.

The Company does not currently provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship.

Service Revenues

Service revenues are primarily attributable to the activities from the High Risk Plaque initiative, for which all revenue has been recorded as of December 31, 2013. The Company does not expect to record service revenues in 2014 or beyond.

Inventory

Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following:

 

(in thousands)        June 30, 2014          December 31, 2013  

Raw materials

   $ 86       $ 107   

Finished goods

     468         352   
  

 

 

    

 

 

 

Total inventories

   $ 554       $ 459   
  

 

 

    

 

 

 

Net Loss Per Share

Basic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented.

 

The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  
     (in thousands, except share and per share data)  

Net loss

   $ (2,169   $ (4,837   $ (4,348   $ (10,249

Weighted average number of shares - basic and diluted

     33,915,465        27,649,879        30,942,514        26,490,682   

Net loss per share - basic and diluted

   $ (0.06   $ (0.18   $ (0.14   $ (0.39

For the three and six months ended June 30, 2014 and 2013, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported:

 

     Three and Six Months Ended June 30,  
     2014      2013  

Options to purchase common stock

     3,042,661         2,913,192  

Warrants to purchase common stock

     864,555         864,555   
XML 21 R3.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Balance Sheets (Parenthetical) (USD $)
Jun. 30, 2014
Dec. 31, 2013
Common stock, par value $ 0.001 $ 0.001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 34,417,249 27,936,222
Common stock, shares outstanding 34,417,249 27,936,222
XML 22 R17.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Computation of Basic and Diluted Net Loss Per Share (Detail) (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Schedule Of Computation Of Basic And Diluted Earnings Per Common Share [Line Items]        
Net loss $ (2,169) $ (4,837) $ (4,348) $ (10,249)
Weighted average number of shares - basic and diluted 33,915,465 27,649,879 30,942,514 26,490,682
Net loss per share - basic and diluted $ (0.06) $ (0.18) $ (0.14) $ (0.39)
XML 23 R1.htm IDEA: XBRL DOCUMENT v2.4.0.8
Document and Entity Information
6 Months Ended
Jun. 30, 2014
Jul. 31, 2014
Document Information [Line Items]    
Document Type 10-Q  
Amendment Flag false  
Document Period End Date Jun. 30, 2014  
Document Fiscal Year Focus 2014  
Document Fiscal Period Focus Q2  
Trading Symbol BGMD  
Entity Registrant Name BG MEDICINE, INC.  
Entity Central Index Key 0001407038  
Current Fiscal Year End Date --12-31  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   34,417,249
XML 24 R18.htm IDEA: XBRL DOCUMENT v2.4.0.8
Common Shares Excluded From Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Detail)
3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Options to purchase common stock
       
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share 3,042,661 2,913,192 3,042,661 2,913,192
Warrants to purchase common stock
       
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share 864,555 864,555 864,555 864,555
XML 25 R4.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statements of Operations (USD $)
In Thousands, except Share data, unless otherwise specified
3 Months Ended 6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Revenues:        
Product revenues $ 799 $ 972 $ 1,538 $ 1,792
Service revenues   34   102
Total revenues 799 1,006 1,538 1,894
Costs and operating expenses:        
Product costs 281 353 529 633
Service costs   34   102
Research and development 573 1,117 1,133 2,493
Selling and marketing 733 1,782 1,421 3,926
General and administrative 1,183 2,269 2,373 4,090
Total costs and operating expenses 2,770 5,555 5,456 11,244
Loss from operations (1,971) (4,549) (3,918) (9,350)
Non-cash consideration associated with stock purchase agreement       (329)
Interest income   6 2 10
Interest expense (199) (295) (432) (584)
Other income 1 1   4
Net loss $ (2,169) $ (4,837) $ (4,348) $ (10,249)
Net loss per share - basic and diluted $ (0.06) $ (0.18) $ (0.14) $ (0.39)
Weighted-average common shares outstanding used in computing per share amounts - basic and diluted 33,915,465 27,649,879 30,942,514 26,490,682
XML 26 R12.htm IDEA: XBRL DOCUMENT v2.4.0.8
Follow-on Public Offerings
6 Months Ended
Jun. 30, 2014
Follow-on Public Offerings
7. Follow-on Public Offerings

On January 30, 2013, the Company closed a follow-on underwritten public offering of 6,900,000 shares of its common stock, at an offering price of $2.00 per share, for gross proceeds of $13.8 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $12.8 million.

On April 8, 2014, the Company closed a follow-on underwritten public offering of 6,452,000 shares of its common stock, at an offering price of $1.55 per share, for gross proceeds of $10.0 million. The net offering proceeds received by the Company, after deducting underwriting discounts and commissions and expenses incurred in connection with the offering, were approximately $9.0 million.

XML 27 R11.htm IDEA: XBRL DOCUMENT v2.4.0.8
Common Stock Purchase Agreement
6 Months Ended
Jun. 30, 2014
Common Stock Purchase Agreement
6. Common Stock Purchase Agreement

On January 24, 2013, the Company entered into a Common Stock Purchase Agreement (“Purchase Agreement”), with Aspire Capital Fund, LLC to purchase, at the Company’s option, up to an aggregate of $12.0 million of shares of its common stock over a two-year term, which expires in May 2015. Under the Purchase Agreement, the Company initially issued 132,743 shares of its common stock as a commitment fee. The Company’s sales to Aspire will be made subject to market conditions, in light of its capital needs and under various limitations contained in the Purchase Agreement, including a floor price of $1.00 per share required by the Purchase Agreement. The Company has not yet sold any shares under the Purchase Agreement, which expires in May 2015.

Over the term of the Purchase Agreement, assuming the Company’s common stock is trading above the $1.00 floor price that is required to use the facility, the Company has two ways to elect to sell common stock to Aspire on any business day the Company selects: (1) through a regular purchase of up to 100,000 shares at prices based on the market price of the Company’s common stock prior to the time of each sale, and (2) through a volume weighted average price (“VWAP”), purchase of a number of shares up to 30% of the volume traded on the purchase date at a price equal to the lesser of the closing sale price or 95% of the VWAP for such purchase date.

The Company also entered into a Registration Rights Agreement with Aspire, which requires, among other things, that the Company maintain the effectiveness of the Company’s registration statement that registered the shares issued and issuable to Aspire under the Purchase Agreement.

XML 28 R19.htm IDEA: XBRL DOCUMENT v2.4.0.8
Term Loan - Additional Information (Detail) (Term loans, USD $)
1 Months Ended 6 Months Ended
May 31, 2013
Jun. 30, 2014
Feb. 10, 2012
Debt Instrument [Line Items]      
Loan facility amount borrowed   $ 5,200,000 $ 10,000,000
Line of credit, interest rate   8.00%  
Principal and interest payments maturity date   Sep. 30, 2015  
Interest rate description   The term loan accrues interest at a rate of 8% per annum plus the higher of (a) the 3-month LIBOR rate or (b) 1.25%. The interest rate in effect at June 30, 2014 was 9.25%.  
Line of credit, current interest rate   9.25%  
Increase in loan fee 50,000    
Warrant issued to purchase common stock 110,401 36,657  
Exercise price of common stock   6.82  
Warrant expiration period   10 years  
Fair value of the underlying common stock   $ 8.51  
Warrant, volatility   70.00%  
Warrant, weighted average risk-free interest rate   1.96%  
Warrant fair value   240,000  
Additional debt discount $ 163,000    
Adjusted
     
Debt Instrument [Line Items]      
Exercise price of common stock 1.70    
XML 29 R15.htm IDEA: XBRL DOCUMENT v2.4.0.8
Description of Business and Basis of Presentation - Additional Information (Detail) (USD $)
3 Months Ended 6 Months Ended 0 Months Ended 0 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Jun. 30, 2014
Jun. 30, 2013
Dec. 31, 2013
Dec. 31, 2012
Apr. 08, 2014
Underwritten Public Offering
Jan. 30, 2013
Underwritten Public Offering
Apr. 08, 2014
Underwritten Public Offering
Jan. 30, 2013
Underwritten Public Offering
Jan. 24, 2013
Common Stock Purchase Agreement
Aspire Capital Fund LLC
Jun. 30, 2014
Common Stock Purchase Agreement
Aspire Capital Fund LLC
Jun. 30, 2014
Centers for Medicare And Medicaid Services
Dec. 31, 2013
Centers for Medicare And Medicaid Services
Jun. 30, 2014
Term loans
Feb. 10, 2012
Term loans
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items]                                
Cash $ 9,538,000 $ 16,203,000 $ 9,538,000 $ 16,203,000 $ 7,751,000 $ 12,786,000                    
Outstanding balance of term loan facility                             5,200,000 10,000,000
Stockholders' equity 3,982,000   3,982,000   (1,069,000)                      
Net loss (2,169,000) (4,837,000) (4,348,000) (10,249,000)                        
Net cash flows used in operating activities     (4,992,000) (8,808,000)                        
Shares of common stock under public offering             6,452,000 6,900,000     132,743          
Common stock Offering price                 $ 1.55 $ 2.00            
Gross proceeds offering             10,000,000 13,800,000                
Offering proceeds net of underwriting discounts, commissions and expenses             9,000,000 12,800,000                
Reimbursed price per test                         30.01 17.80    
Common stock sale amount under purchase agreement                     12,000,000 12,000,000        
Common stock purchase agreement, expiration period                       2015-05        
Common stock available for sale amount under purchase agreement                       0        
Available fund pursuant to common stock purchase agreement                       $ 4,100,000        
Minimum floor price of common stock                       $ 1.00        
Common stock purchase agreement, conditions                       In order for the Company to sell shares to Aspire under the Purchase Agreement, the Company's common stock must trade above the $1.00 minimum floor price set forth in the Purchase Agreement.        
XML 30 R13.htm IDEA: XBRL DOCUMENT v2.4.0.8
Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2014
Revenue Recognition

Product Revenues

Product revenues are recognized when the following criteria have been met: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred and risk of loss has passed; (iii) the seller’s price to the buyer is fixed or determinable; and (iv) collectability is reasonably assured.

The Company sells its products through supply agreements with laboratory testing services and diagnostic testing distributors and directly to hospitals and clinics. The Company recognizes revenue when products are received by customers, at which time both title and risk of loss have passed to the customers. The Company negotiates credit terms on a customer-by-customer basis and products are shipped at an agreed-upon price.

Revenue is recorded net of taxes collected from customers that are remitted to governmental authorities, with the collected taxes recorded as current liabilities until remitted to the relevant government authority. Freight costs billed to customers are recorded as revenue.

The Company does not currently provide an allowance for doubtful accounts or a reserve for sales returns as the Company has not experienced any credit losses, and returns are only allowed for defects in workmanship.

Service Revenues

Service revenues are primarily attributable to the activities from the High Risk Plaque initiative, for which all revenue has been recorded as of December 31, 2013. The Company does not expect to record service revenues in 2014 or beyond.

Inventory

Inventory

Inventory is stated at the lower of cost or market. Costs are determined under the first-in, first-out (FIFO) method. Inventories consisted of the following:

 

(in thousands)        June 30, 2014          December 31, 2013  

Raw materials

   $ 86       $ 107   

Finished goods

     468         352   
  

 

 

    

 

 

 

Total inventories

   $ 554       $ 459   
  

 

 

    

 

 

 
Net Loss Per Share

Net Loss Per Share

Basic and diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. Because the Company has reported a net loss for all periods presented, diluted net loss per common share is the same as basic net loss per common share for all periods presented.

 

The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  
     (in thousands, except share and per share data)  

Net loss

   $ (2,169   $ (4,837   $ (4,348   $ (10,249

Weighted average number of shares - basic and diluted

     33,915,465        27,649,879        30,942,514        26,490,682   

Net loss per share - basic and diluted

   $ (0.06   $ (0.18   $ (0.14   $ (0.39

For the three and six months ended June 30, 2014 and 2013, the following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported:

 

     Three and Six Months Ended June 30,  
     2014      2013  

Options to purchase common stock

     3,042,661         2,913,192  

Warrants to purchase common stock

     864,555         864,555   
XML 31 R14.htm IDEA: XBRL DOCUMENT v2.4.0.8
Significant Accounting Policies (Tables)
6 Months Ended
Jun. 30, 2014
Summary of Inventories

Inventories consisted of the following:

 

(in thousands)        June 30, 2014          December 31, 2013  

Raw materials

   $ 86       $ 107   

Finished goods

     468         352   
  

 

 

    

 

 

 

Total inventories

   $ 554       $ 459   
  

 

 

    

 

 

 
Summary of Computation of Basic and Diluted Net Loss per Share

The following table summarizes the computation of basic and diluted net loss per share for the three and six months ended June 30, 2014 and 2013:

 

     Three Months Ended June 30,     Six Months Ended June 30,  
     2014     2013     2014     2013  
     (in thousands, except share and per share data)  

Net loss

   $ (2,169   $ (4,837   $ (4,348   $ (10,249

Weighted average number of shares - basic and diluted

     33,915,465        27,649,879        30,942,514        26,490,682   

Net loss per share - basic and diluted

   $ (0.06   $ (0.18   $ (0.14   $ (0.39
Common Shares Excluded from Computation of Diluted Net Loss per Share Attributable to Common Stockholders

following potential common shares were excluded from the computation of diluted net loss per share because they had an antidilutive impact due to the losses reported:

 

     Three and Six Months Ended June 30,  
     2014      2013  

Options to purchase common stock

     3,042,661         2,913,192  

Warrants to purchase common stock

     864,555         864,555   
XML 32 R16.htm IDEA: XBRL DOCUMENT v2.4.0.8
Summary of Inventories (Detail) (USD $)
In Thousands, unless otherwise specified
Jun. 30, 2014
Dec. 31, 2013
Inventory [Line Items]    
Raw materials $ 86 $ 107
Finished goods 468 352
Total inventories $ 554 $ 459
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Common Stock Purchase Agreement - Additional Information (Detail) (USD $)
0 Months Ended 6 Months Ended
Jan. 24, 2013
Jun. 30, 2014
Maximum
   
Schedule Of Common Share Purchase [Line Items]    
Additional purchase of common stock   100,000
Common Stock Purchase Agreement | Aspire Capital Fund LLC
   
Schedule Of Common Share Purchase [Line Items]    
Common stock sale amount under purchase agreement $ 12,000,000 $ 12,000,000
Common shares issued as consideration for common stock purchase agreement 132,743  
Common stock sale period 2 years  
Common stock purchase agreement, company's floor price per share   $ 1.00
Common stock available for sale amount under purchase agreement   $ 0
Common stock purchase agreement, expiration period   2015-05
Closing Sale Price | Maximum
   
Schedule Of Common Share Purchase [Line Items]    
Percentage of shares to purchase   30.00%
VWAP
   
Schedule Of Common Share Purchase [Line Items]    
Percentage of closing sale price   95.00%
XML 35 R5.htm IDEA: XBRL DOCUMENT v2.4.0.8
Condensed Consolidated Statements of Cash Flows (USD $)
In Thousands, unless otherwise specified
6 Months Ended
Jun. 30, 2014
Jun. 30, 2013
Cash flows from operating activities    
Net loss $ (4,348) $ (10,249)
Adjustments to reconcile net loss to net cash used in operating activities    
Depreciation and amortization 67 100
Stock-based compensation 380 633
Non-cash interest expense 116 99
Non-cash consideration associated with stock purchase agreement   329
Gain on sale of property and equipment   (53)
Changes in operating assets and liabilities    
Restricted cash   102
Accounts receivable (34) (7)
Inventory (95) 178
Prepaid expenses and other assets (38) (115)
Accounts payable, accrued expenses and other liabilities (1,067) 275
Deferred revenue and customer deposits 27 (100)
Net cash flows used in operating activities (4,992) (8,808)
Cash flows from investing activities    
Proceeds from the sale of property and equipment   80
Net cash flows provided by investing activities   80
Cash flows from financing activities    
Proceeds from public offering 9,238 13,058
Costs related to public offering (243) (287)
Payments on term loan (2,240) (666)
Proceeds from ESPP purchases 2 13
Proceeds from the exercise of stock options 22 27
Net cash flows provided by financing activities 6,779 12,145
Net increase in cash 1,787 3,417
Cash, beginning of period 7,751 12,786
Cash, end of period 9,538 16,203
Supplemental disclosure of cash flow information    
Cash paid for interest 319 455
Supplemental disclosure of non-cash activities    
Issuance of common stock warrants accounted for as debt discount   $ 163
XML 36 R10.htm IDEA: XBRL DOCUMENT v2.4.0.8
Commitments and Contingencies
6 Months Ended
Jun. 30, 2014
Commitments and Contingencies
5. Commitments and Contingencies

From time to time, the Company may be subject to various legal proceedings and claims arising in the ordinary course of business. The Company assesses contingencies to determine the degree of probability and range of possible loss for potential accrual in its financial statements. An estimated loss contingency is accrued in the financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated.

The Company was involved in litigation with a former research collaborator resulting from the Company’s termination of its participation in the collaboration. In April 2014, the Company settled this matter for an amount that had been accrued at December 31, 2013. No further losses are expected related to this matter. No other amounts related to contingencies are accrued at June 30, 2014.

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Commitments and Contingencies - Additional Information (Detail) (USD $)
Jun. 30, 2014
Commitments and Contingencies [Line Items]  
Accrued other contingencies $ 0