Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 31, 2014 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
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 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets | ' | ' |
Cash | $6,313 | $7,751 |
Accounts receivable | 254 | 319 |
Inventory | 358 | 459 |
Prepaid expenses and other current assets | 236 | 306 |
Total current assets | 7,161 | 8,835 |
Property and equipment, net | 135 | 192 |
Intangible assets, net | 149 | 192 |
Deposits and other assets | 126 | 134 |
Total assets | 7,571 | 9,353 |
Current liabilities | ' | ' |
Term loan, current portion | 4,059 | 4,353 |
Accounts payable | 425 | 965 |
Accrued expenses | 1,252 | 1,993 |
Other current liabilities | 42 | 39 |
Total current liabilities | 5,778 | 7,350 |
Term loan, net of current portion | ' | 2,961 |
Other liabilities | 97 | 111 |
Total liabilities | 5,875 | 10,422 |
Commitments and contingencies (Note 5) | ' | ' |
Stockholders' equity (deficit) | ' | ' |
Common stock; $.001 par value; 100,000,000 shares authorized at September 30, 2014 and December 31, 2013; 34,417,249 and 27,936,222 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 34 | 28 |
Additional paid-in capital | 161,343 | 151,841 |
Accumulated deficit | -159,681 | -152,938 |
Total stockholders' equity (deficit) | 1,696 | -1,069 |
Total liabilities and stockholders' equity (deficit) | $7,571 | $9,353 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Common stock, par value | $0.00 | $0.00 |
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 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Product revenues | $695 | $1,007 | $2,233 | $2,799 |
Service revenues | ' | 23 | ' | 125 |
Total revenues | 695 | 1,030 | 2,233 | 2,924 |
Costs and operating expenses: | ' | ' | ' | ' |
Product costs | 234 | 321 | 764 | 954 |
Service costs | ' | 23 | ' | 125 |
Research and development | 724 | 1,048 | 1,855 | 3,541 |
Selling and marketing | 647 | 1,353 | 2,069 | 5,279 |
General and administrative | 1,323 | 1,648 | 3,696 | 5,738 |
Total costs and operating expenses | 2,928 | 4,393 | 8,384 | 15,637 |
Loss from operations | -2,233 | -3,363 | -6,151 | -12,713 |
Non-cash consideration associated with stock purchase agreement | ' | ' | ' | -329 |
Interest income | ' | 3 | 2 | 13 |
Interest expense | -165 | -309 | -597 | -893 |
Other income | 1 | 4 | 2 | 8 |
Net loss | ($2,397) | ($3,665) | ($6,744) | ($13,914) |
Net loss per share - basic and diluted | ($0.07) | ($0.13) | ($0.21) | ($0.52) |
Weighted-average common shares outstanding used in computing per share amounts - basic and diluted | 34,417,249 | 27,918,883 | 32,113,490 | 26,971,981 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Cash flows from operating activities | ' | ' |
Net loss | ($6,744) | ($13,914) |
Adjustments to reconcile net loss to net cash used in operating activities | ' | ' |
Depreciation and amortization | 100 | 236 |
Stock-based compensation | 489 | 914 |
Non-cash interest expense | 164 | 144 |
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 | ' | 125 |
Accounts receivable | 65 | -56 |
Inventory | 101 | 36 |
Prepaid expenses and other assets | 78 | -74 |
Accounts payable, accrued expenses and other liabilities | -1,349 | -393 |
Deferred revenue and customer deposits | -1 | -114 |
Net cash flows used in operating activities | -7,097 | -12,820 |
Cash flows from investing activities | ' | ' |
Purchases of property and equipment | ' | -115 |
Proceeds from the sale of property and equipment | ' | 100 |
Net cash flows used in investing activities | ' | -15 |
Cash flows from financing activities | ' | ' |
Proceeds from public offering | 9,238 | 13,800 |
Costs related to public offering | -243 | -1,029 |
Payments on term loan | -3,360 | -1,413 |
Proceeds from ESPP purchases | 2 | 13 |
Proceeds from the exercise of stock options | 22 | 27 |
Net cash flows provided by financing activities | 5,659 | 11,398 |
Net increase in cash | -1,438 | -1,437 |
Cash, beginning of period | 7,751 | 12,786 |
Cash, end of period | 6,313 | 11,349 |
Supplemental disclosure of cash flow information | ' | ' |
Cash paid for interest | 433 | 673 |
Supplemental disclosure of non-cash activities | ' | ' |
Issuance of common stock warrants accounted for as debt discount | ' | $163 |
Description_of_Business_and_Ba
Description of Business and Basis of Presentation | 9 Months Ended | |
Sep. 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’s BGM Galectin-3® Test is 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. The BGM Galectin-3® Test is cleared by the U.S. Food and Drug Administration (the “FDA”), is CE-marked and is currently available as a blood test in the United States and the European Union (“EU”). The Company is currently focused on preparing for the anticipated U.S. market introduction of galectin-3 automated testing by its automated diagnostic instrument manufacturing partners by conducting clinical research studies that seek to affirm the potential clinical utility and impact of galectin-3 testing in heart failure and related disorders and by continuing to support and promote the publication of the results of clinical research studies. | ||
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 September 30, 2014 and results of operations and cash flows for the interim periods ended September 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 nine months ended September 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 September 30, 2014, the Company had cash totaling $6.3 million, an outstanding balance of $4.1 million under a secured term loan facility, and stockholders’ equity of $1.7 million. During the nine months ended September 30, 2014, the Company incurred a net loss of $6.7 million and used cash in operating activities totaling $7.1 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 is in the early stages of commercializing its BGM Galectin-3 Test. In order to achieve profitability, the Company will need to generate significant product revenues. The Company believes that automation of its galectin-3 test will broaden its acceptance by laboratory customers and, as a result, accelerate its clinical adoption. To that end, the Company has entered into licensing and commercialization agreements with four leading diagnostic instrument manufacturers to develop and commercialize automated instrument versions of its galectin-3 test. | ||
On September 11, 2014, the Company implemented a reduction of approximately 55% of its workforce, or 12 people (the “Restructuring”), leaving 10 employees. The Company took this step in order to reduce its operating expenses and extend its cash runway in anticipation of the commercial launch of automated versions of the Company’s galectin-3 test. The automated galectin-3 tests are being developed and commercialized by the Company’s diagnostic instrument manufacturing partners and will be performed on the partners’ automated platforms. The first automated version of the galectin-3 test is expected to be launched in the United States in 2015. | ||
The Restructuring primarily eliminated the Company’s sales and marketing organization and removed certain positions in other functional areas, while preserving some senior management and other critical roles to support the clinical and commercial adoption of galectin-3 testing by generating, publishing and publicizing data derived from clinical research studies and by expanding the BGM Galectin-3 Test’s labeling indications for use through additional clinical studies and clearances by the FDA. | ||
Employees affected by the Restructuring were notified on September 11, 2014 and were provided with severance arrangements including outplacement assistance. As a result of the Restructuring, the Company recorded total one-time charges with respect to severance payments and benefits continuation of approximately $404,000 in the third quarter of 2014, of which, $128,000, $114,000 and $162,000 was recorded in research and development, sales and marketing and general and administrative expense, respectively. Approximately $58,000 was paid during the third quarter and the remaining $346,000, included in accrued expenses, will be paid out during the fourth quarter of 2014 and the first quarter of 2015. As a result of the Restructuring, the Company estimates it will generate annualized expense savings of approximately $1.9 million primarily from savings in employee salaries and benefits. | ||
As further described in Note 4, the Company has a term loan facility that 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 will be sufficient to fund its operations and service its debt into the second quarter of 2015. 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 through the second quarter of 2015 and beyond. 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. On November 13, 2014, the Company announced that it had retained Stifel Nicolaus & Company, Incorporated, an investment banking firm, to assist in reviewing and evaluating a full range of strategic alternatives to enhance shareholder value. The strategic alternatives could include, among others, possible joint ventures, strategic partnerships or alliances, a merger or sale of the Company or other possible transactions. | ||
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 through the second quarter of 2015 and beyond. 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. | ||
In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”). ASU 2014-15 introduces an explicit requirement for management to assess if there is substantial doubt about an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. In connection with each annual and interim period, management must assess if there is substantial doubt about an entity’s ability to continue as a going concern within one year after the issuance date. Disclosures are required if conditions give rise to substantial doubt. ASU 2014-15 is effective for all entities in the first annual period ending after December 15, 2016. The Company has reviewed ASU 2014-15 and does not currently expect the standard to have an impact on its consolidated financial statements. |
Significant_Accounting_Policie
Significant Accounting Policies | 9 Months Ended | ||||||||||||||||
Sep. 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: | |||||||||||||||||
September 30, 2014 | December 31, 2013 | ||||||||||||||||
(in thousands) | |||||||||||||||||
Raw materials | $ | 86 | $ | 107 | |||||||||||||
Finished goods | 272 | 352 | |||||||||||||||
Total inventories | $ | 358 | $ | 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 nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Net loss | $ | (2,397 | ) | $ | (3,665 | ) | $ | (6,744 | ) | $ | (13,914 | ) | |||||
Weighted average number of shares - basic and diluted | 34,417,249 | 27,918,883 | 32,113,490 | 26,971,981 | |||||||||||||
Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.13 | ) | $ | (0.21 | ) | $ | (0.52 | ) | |||||
For the three and nine months ended September 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 Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Options to purchase common stock | 2,579,321 | 2,608,282 | |||||||||||||||
Warrants to purchase common stock | 864,555 | 864,555 |
Fair_Value_of_Financial_Instru
Fair Value of Financial Instruments | 9 Months Ended | |
Sep. 30, 2014 | ||
Fair Value of Financial Instruments | ' | |
3 | Fair Value of Financial Instruments | |
At September 30, 2014, the Company’s financial instruments consisted 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. |
Term_Loan
Term Loan | 9 Months Ended | |
Sep. 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 September 30, 2014 was 9.25% per annum. 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. | ||
At September 30, 2014, the Company had $4.1 million outstanding under the term loan. | ||
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. |
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended | |
Sep. 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 September 30, 2014. |
Common_Stock_Purchase_Agreemen
Common Stock Purchase Agreement | 9 Months Ended | |
Sep. 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 sell, 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, if any, 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 was not eligible to sell any shares under the Purchase Agreement during the purchase period ended September 30, 2014 because the trading price of its common stock did not exceed the $1.00 floor price. 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. |
Followon_Public_Offerings
Follow-on Public Offerings | 9 Months Ended | |
Sep. 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. |
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 9 Months Ended | ||||||||||||||||
Sep. 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: | |||||||||||||||||
September 30, 2014 | December 31, 2013 | ||||||||||||||||
(in thousands) | |||||||||||||||||
Raw materials | $ | 86 | $ | 107 | |||||||||||||
Finished goods | 272 | 352 | |||||||||||||||
Total inventories | $ | 358 | $ | 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 nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Net loss | $ | (2,397 | ) | $ | (3,665 | ) | $ | (6,744 | ) | $ | (13,914 | ) | |||||
Weighted average number of shares - basic and diluted | 34,417,249 | 27,918,883 | 32,113,490 | 26,971,981 | |||||||||||||
Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.13 | ) | $ | (0.21 | ) | $ | (0.52 | ) | |||||
For the three and nine months ended September 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 Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Options to purchase common stock | 2,579,321 | 2,608,282 | |||||||||||||||
Warrants to purchase common stock | 864,555 | 864,555 |
Significant_Accounting_Policie2
Significant Accounting Policies (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Summary of Inventories | ' | ||||||||||||||||
Inventories consisted of the following: | |||||||||||||||||
September 30, 2014 | December 31, 2013 | ||||||||||||||||
(in thousands) | |||||||||||||||||
Raw materials | $ | 86 | $ | 107 | |||||||||||||
Finished goods | 272 | 352 | |||||||||||||||
Total inventories | $ | 358 | $ | 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 nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||||
Net loss | $ | (2,397 | ) | $ | (3,665 | ) | $ | (6,744 | ) | $ | (13,914 | ) | |||||
Weighted average number of shares - basic and diluted | 34,417,249 | 27,918,883 | 32,113,490 | 26,971,981 | |||||||||||||
Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.13 | ) | $ | (0.21 | ) | $ | (0.52 | ) | |||||
Common Shares Excluded from Computation of Diluted Net Loss per Share Attributable to Common Stockholders | ' | ||||||||||||||||
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 Nine Months Ended September 30, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Options to purchase common stock | 2,579,321 | 2,608,282 | |||||||||||||||
Warrants to purchase common stock | 864,555 | 864,555 |
Description_of_Business_and_Ba1
Description of Business and Basis of Presentation - Additional Information (Detail) (USD $) | 0 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 0 Months Ended | 9 Months Ended | 12 Months Ended | |||||||||||
Sep. 11, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Apr. 08, 2014 | Jan. 30, 2013 | Apr. 08, 2014 | Jan. 30, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | |
Employee | Entity | Employee Severance | Research and Development Expense | Selling and Marketing Expense | General and Administrative Expense | Underwritten Public Offering | Underwritten Public Offering | Underwritten Public Offering | Underwritten Public Offering | Centers for Medicare And Medicaid Services | Centers for Medicare And Medicaid Services | Term loans | ||||||
Description Of Business Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cash | ' | $6,313,000 | $11,349,000 | $6,313,000 | $11,349,000 | $7,751,000 | $12,786,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Loan facility | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4,100,000 |
Stockholders' equity | ' | 1,696,000 | ' | 1,696,000 | ' | -1,069,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net loss | ' | -2,397,000 | -3,665,000 | -6,744,000 | -13,914,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net cash flows used in operating activities | ' | ' | ' | -7,097,000 | -12,820,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock under public offering | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,452,000 | 6,900,000 | ' | ' | ' | ' | ' |
Common stock Offering price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.55 | $2 | ' | ' | ' |
Gross proceeds offering | ' | ' | ' | 9,238,000 | 13,800,000 | ' | ' | ' | ' | ' | ' | 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 | 17.8 | ' |
Number of leading diagnostic instrument manufactures | ' | ' | ' | 4 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Reduction in workforce, percentage | 55.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of employees expected to be eliminated | 12 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of employees eliminated | 10 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Severance payments and benefits continuation | ' | 404,000 | ' | ' | ' | ' | ' | ' | 128,000 | 114,000 | 162,000 | ' | ' | ' | ' | ' | ' | ' |
Payment for severance payments and benefits continuation | ' | ' | ' | ' | ' | ' | ' | 58,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Accrued severance payments and benefits continuation | ' | ' | ' | ' | ' | ' | ' | 346,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Savings in employee salaries and benefits | ' | $1,900,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Summary_of_Inventories_Detail
Summary of Inventories (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ' | ' |
Raw materials | $86 | $107 |
Finished goods | 272 | 352 |
Total inventories | $358 | $459 |
Summary_of_Computation_of_Basi
Summary of Computation of Basic and Diluted Net Loss Per Share (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Schedule Of Computation Of Basic And Diluted Earnings Per Common Share [Line Items] | ' | ' | ' | ' |
Net loss | ($2,397) | ($3,665) | ($6,744) | ($13,914) |
Weighted average number of shares - basic and diluted | 34,417,249 | 27,918,883 | 32,113,490 | 26,971,981 |
Net loss per share - basic and diluted | ($0.07) | ($0.13) | ($0.21) | ($0.52) |
Common_Shares_Excluded_From_Co
Common Shares Excluded From Computation of Diluted Net Loss Per Share Attributable to Common Stockholders (Detail) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 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 | 2,579,321 | 2,608,282 | 2,579,321 | 2,608,282 |
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 |
Term_Loan_Additional_Informati
Term Loan - Additional Information (Detail) (Term loans, USD $) | 0 Months Ended | 1 Months Ended | 9 Months Ended | |
Feb. 10, 2012 | 31-May-13 | Sep. 30, 2014 | Feb. 10, 2012 | |
Debt Instrument [Line Items] | ' | ' | ' | ' |
Loan facility amount borrowed | ' | ' | ' | $10,000,000 |
Line of credit, interest rate | ' | ' | 8.00% | ' |
Principal and interest payments maturity date | ' | ' | 30-Sep-15 | ' |
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 September 30, 2014 was 9.25% per annum. | ' |
Line of credit, current interest rate | ' | ' | 9.25% | ' |
Increase in loan fee | ' | 50,000 | ' | ' |
Loan facility | ' | ' | 4,100,000 | ' |
Warrant issued to purchase common stock | 36,657 | 110,401 | ' | ' |
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 | ' | ' |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | Sep. 30, 2014 |
Commitments and Contingencies [Line Items] | ' |
Accrued other contingencies | $0 |
Common_Stock_Purchase_Agreemen1
Common Stock Purchase Agreement - Additional Information (Detail) (USD $) | 0 Months Ended | 9 Months Ended |
Jan. 24, 2013 | Sep. 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 | ' |
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 |
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% |
Followon_Public_Offerings_Addi
Follow-on Public Offerings - Additional Information (Detail) (USD $) | 9 Months Ended | 0 Months Ended | ||||
Sep. 30, 2014 | Sep. 30, 2013 | Apr. 08, 2014 | Jan. 30, 2013 | Apr. 08, 2014 | Jan. 30, 2013 | |
Underwritten Public Offering | Underwritten Public Offering | Underwritten Public Offering | 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 |
Gross proceeds offering | $9,238,000 | $13,800,000 | $10,000,000 | $13,800,000 | ' | ' |
Offering proceeds net of underwriting discounts, commissions and expenses | ' | ' | $9,000,000 | $12,800,000 | ' | ' |