Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2014 |
Significant Accounting Policies [Line Items] | ' |
Basis of Consolidation | ' |
Basis of Consolidation |
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The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary, Response Genetics, Ltd., a Scottish corporation (the “Subsidiary”), which was incorporated in November 2006. The Subsidiary had no employees or active operations in 2013 or to date in 2014. All significant intercompany transactions and balances have been eliminated in consolidation. |
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Cash and Cash Equivalents | ' |
Cash and Cash Equivalents |
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The Company considers all highly liquid investments with a maturity date of three months or less from the date of purchase to be cash equivalents. The carrying value of cash equivalents approximates fair value due to the short-term nature and liquidity of these instruments. The Company’s cash equivalents are comprised of cash on hand, deposits in banks and money market investments. |
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Accounts Receivable | ' |
Accounts Receivable |
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Pharmaceutical Accounts Receivable |
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The Company invoices its clients as specimens are processed and any other contractual obligations are met. The Company’s contracts with clients typically require payment within 45 days of the date of invoice. The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its clients to make required payments. The Company specifically analyzes accounts receivable and historical bad debts, client credit, current economic trends and changes in client payment trends when evaluating the adequacy of the allowance for doubtful accounts. Account balances are charged-off against the allowance when it is probable the receivable will not be recovered. To date, the Company’s pharmaceutical customers have primarily been large pharmaceutical companies. As a result, bad debts from pharmaceutical accounts receivable to date have been minimal. Pharmaceutical company accounts receivable as of December 31, 2013 and September 30, 2014 were $1,892,384 and $769,294, respectively. There were no allowances for doubtful accounts recorded against these pharmaceutical accounts receivable at December 31, 2013 and September 30, 2014. |
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ResponseDX® Accounts Receivable |
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ResponseDX® accounts receivable are recorded from two primary payors: (1) Medicare and (2) third party payors such as commercial insurance and private payors or self-paying payors (“Private Payors”). ResponseDX® accounts receivable are recorded at established billing rates less an estimated billing adjustment, based on reporting models utilizing historical cash collection percentages and updated for current effective reimbursement factors. Management performs ongoing valuations of accounts receivable balances based on management’s evaluation of historical collection experience and industry trends. Based on the historical experience for our Medicare and Private Payor accounts, management has determined, based on a detailed analysis, that accounts receivable associated with certain billings are unlikely to be collected. Therefore, the Company has recorded an allowance for doubtful accounts of $2,404,659 and $2,204,177 as of December 31, 2013 and September 30, 2014, respectively. The Company’s bad debt expense for the three months ended September 30, 2013 and 2014 was $688,205 and $1,604,320, respectively, and for the nine months ended September 30, 2013 and 2014 was $1,506,654 and $4,266,013, respectively. |
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ResponseDX® accounts receivable as of December 31, 2013 and September 30, 2014, consisted of the following: |
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| | December 31, | | September 30, | | | | | | | | | | | | | | | | | | |
| | 2013 | | 2014 | | | | | | | | | | | | | | | | | | |
| | | | (Unaudited) | | | | | | | | | | | | | | | | | | |
Net Medicare receivable | | $ | 2,422,611 | | $ | 2,377,560 | | | | | | | | | | | | | | | | | | |
Net Private Payor receivable | | | 4,315,587 | | | 5,946,423 | | | | | | | | | | | | | | | | | | |
| | | 6,738,198 | | | 8,323,983 | | | | | | | | | | | | | | | | | | |
Allowance for doubtful accounts | | | -2,404,659 | | | -2,204,177 | | | | | | | | | | | | | | | | | | |
Total | | $ | 4,333,539 | | $ | 6,119,806 | | | | | | | | | | | | | | | | | | |
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Property and Equipment | ' |
Property and Equipment |
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Property and equipment are carried at cost less accumulated depreciation and amortization. Depreciation and amortization are calculated using the double declining balance and straight-line methods over the estimated useful lives of the assets. The Company has determined the estimated useful lives of its property and equipment, as follows: |
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Laboratory equipment | | 5 to 7 years | | | | | | | | | | | | | | | | | | | | | | |
Furniture and equipment | | 3 to 7 years | | | | | | | | | | | | | | | | | | | | | | |
Leasehold improvements | | Shorter of the useful life (5 to 7 years) or the lease term | | | | | | | | | | | | | | | | | | | | | | |
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Maintenance and repairs are charged to expense as incurred. The cost and accumulated depreciation of assets sold or otherwise disposed of are removed from the related accounts and the resulting gain or loss is reflected in the statements of operations. |
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Intangible Assets | ' |
Intangible Assets |
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Intangible assets are carried at the cost to obtain them. Purchased software and internally-developed intangible assets are amortized using the straight-line method over estimated useful lives of three to five years. The Company has capitalized costs related to the development of database software. (See Note 3.) The portion of this database placed into service is amortized in accordance with ASC 350-40, Internal-Use Software. The amortization period is five years using the straight-line method. |
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Revenue Recognition | ' |
Revenue Recognition |
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Pharmaceutical Revenue |
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Revenues that are derived from testing services provided to pharmaceutical companies are recognized on a contract specific basis pursuant to the terms of the related agreements. Revenue is recognized in accordance with ASC 605, Revenue Recognition, which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred and title and the risks and rewards of ownership have been transferred to the client or services have been rendered; (3) the price is fixed or determinable; and (4) collectability is reasonably assured. |
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Revenues are recorded on an accrual basis as the contractual obligations are completed and as a set of assays is processed through the Company’s laboratory under a specified contractual protocol and are recorded on the date the tests are completed. Certain contracts have minimum assay requirements that, if not met, result in payments that are due upon the completion of the designated period. In these cases, revenues are recognized when the end of the specified contract period is reached. |
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On occasion, the Company may enter into a contract that requires the client to provide an advance payment for specimens that will be processed at a later date. In these cases, the Company records this advance as deferred revenue and recognizes the revenue as the specimens are processed or at the end of the contract period, as appropriate. |
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The Company recorded revenue from pharmaceutical clients for the three months ended September 30, 2013 and 2014 of $1,550,765 and $547,406, respectively and for the nine months ended September 30, 2013 and 2014 of $6,200,295 and $1,724,069, respectively. |
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ResponseDX® Revenue |
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Revenues that are derived from ResponseDX® testing services are recognized in accordance with ASC 605, Revenue Recognition, which requires that four basic criteria be met before revenue can be recognized: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred and title and the risks and rewards of ownership have been transferred to the client or services have been rendered; (3) the price is fixed or determinable; and (4) collectability is reasonably assured. We record revenues when our tests have confirmed results, which are evidence that the services have been performed. |
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Revenues are recorded on an accrual basis as the contractual obligations are completed and as a set of assays is processed through our laboratory under a specified contractual protocol. |
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ResponseDX® Private Payor and Medicare revenues are recorded at established billing rates less an estimated billing adjustment, based on reporting models utilizing historical cash collection percentages and updated for current effective reimbursement factors. The Company’s Medicare provider number allows it to invoice and collect from Medicare. The Company’s invoicing to Medicare is primarily based on amounts allowed by Medicare for the service provided as defined by Current Procedural Terminology (“CPT”). |
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The following details ResponseDX® revenue for the periods indicated: |
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| | Three Months | | Nine Months | | | | | | | | | | | | |
| | Ended September 30, | | Ended September 30, | | | | | | | | | | | | |
| | (Unaudited) | | (Unaudited) | | | | | | | | | | | | |
| | 2013 | | 2014 | | 2013 | | 2014 | | | | | | | | | | | | |
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Net Medicare revenue | | $ | 956,716 | | $ | 857,786 | | $ | 3,379,405 | | $ | 3,378,203 | | | | | | | | | | | | |
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Net Private Payor revenue | | | 1,584,796 | | | 3,059,799 | | | 5,450,682 | | | 7,538,888 | | | | | | | | | | | | |
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Net ResponseDX® revenue | | $ | 2,541,512 | | $ | 3,917,585 | | $ | 8,830,087 | | $ | 10,917,091 | | | | | | | | | | | | |
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Cost-Containment Measures |
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Both government and private pay sources have instituted cost-containment measures designed to limit payments made to providers of health care services, which include diagnostic testing service providers such as the Company. As a result of these cost containment measures and increased administrative resources required to address these measures, the Company continues to experience elongated time to collect payments and non-payment from payors. There can be no assurance that these measures and any future measures designed to limit payments made to providers will not adversely affect the Company. |
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Regulatory Matters |
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A portion of the Company’s revenues are derived from Medicare reimbursement. Laws and regulations governing Medicare programs are complex and subject to change and to interpretation, and the Company may be adversely affected by future changes in the applicable laws and regulations and governmental investigations, lawsuits or private actions which include mandatory damages, fines, penalties, criminal charges, loss or suspension of licenses and/or suspension or exclusion from Medicare and certain other governmental programs. The Company believes that it is in compliance with all applicable laws and regulations and is not aware of any pending or threatened investigations involving allegations of potential wrongdoing. |
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Medicare reimbursement rates are also subject to regulatory changes and government funding restrictions. In January 2013, a Medicare fee schedule update was announced which included proposed changes to Medicare reimbursement rates that significantly reduced the reimbursement rates for certain of the testing services we provide. The Company participated with other impacted organizations to provide guidance to the local Medicare Administrative Contractor (“MAC”) that resulted in the local MAC updating certain pricing which reflected an increase in many of the tests originally priced in January 2013. On October 1, 2013, the Centers for Medicare and Medicaid Services (“CMS”) issued updated payment rates for some, but not all, of the CPT codes used by the Company. |
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As a result of these CPT code changes and Medicare price changes, we have experienced a departure from our normal reimbursement patterns with Medicare and other payors. Specifically, we have experienced delays in certain reimbursements for services and an increase in initial denials of claims for certain services provided. Accordingly, we re-evaluated the assumptions employed in our model for estimating revenue to be recognized for ResponseDX® testing. We view the code and price changes described above as affecting only the assumptions we used in pricing our services. The nature of the testing we provide, the evidence we gather to establish the creditworthiness of our payors and the delivery method of our services have not changed from prior periods, and there are no indicators that these assumptions require change. |
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We performed an analysis that considered our historical patterns of revenue by payor in conjunction with the fluctuations we experienced in the three and nine months ended September 30, 2013 and 2014 to arrive at the revenue recorded during those periods. We believe that the changes in CPT codes and pricing that are causing confusion and erratic payment experience in the payor community will take some time to resolve. The time needed for resolution will depend upon Medicare and the local MAC releasing additional pricing changes and potentially, revisions to previously revised prices, and upon the private payor community adopting the new CPT codes and some level of revised pricing. Accordingly, our revenue recognition estimates could be materially affected in future periods as pricing and payments patterns change and develop, and we may be materially affected by future or retroactive price changes. |
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On October 31, 2014, CMS released CMS-1612-FC, a new final rule with comment period (the “Final Rule”) entitled “Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access to Identifiable Data for the Center for Medicare and Medicaid Innovation Models & Other Revisions to Part B for CY 2015”. The Final Rule which was initially proposed on July 3, 2014 contains a number of provisions including new and modified CPT codes that may adversely impact the level of reimbursement for certain tests offered by the Company, including fluorescent in-situ hybridization (“FISH”) tests for which the Company receives reimbursement from the Medicare program beginning on January 1, 2015. Although we are still assessing the Final Rule, if it is enacted as drafted, it will materially impact our FISH reimbursements for 2015. The Final Rule is subject to a 60 days comment period, ending on December 30, 2014. |
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Additionally, CMS has as part of its regulatory structure the National Correct Coding Initiative (“NCCI”). Recent changes to NCCI guidance may reduce allowable quantities billed for FISH testing. These changes would lower reimbursement amounts for FISH tests, and there can be no assurance that CMS will make any modifications in the existing language of the NCCI documents. |
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A number of proposals for legislation or regulation continue to be under discussion which could have the effect of substantially reducing Medicare reimbursements for clinical laboratories or introducing cost sharing to beneficiaries. Depending upon the nature of regulatory action, if any, which is taken and the content of legislation, if any, which is adopted, the Company could experience a significant decrease in revenues from Medicare and Medicaid, which could have a material adverse effect on the Company. The Company is unable to predict, however, the extent to which such actions will be taken. |
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Cost of Revenue | ' |
Cost of Revenue |
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Cost of revenue represents the cost of materials, direct labor, royalties, costs associated with processing tissue specimens including pathological review, staining, microdissection, paraffin extraction, reverse transcription polymerase chain reaction (“PCR”), FISH, quality control analyses, license fees and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. |
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Research and Development | ' |
Research and Development |
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The Company expenses costs associated with research and development activities as incurred. Research and development costs are expensed as incurred and classified as research and development costs. Research and development costs include employee costs (salaries, payroll taxes, benefits, and travel), equipment depreciation and warranties and maintenance, laboratory supplies, primers and probes, reagents, patent costs and occupancy costs. |
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Line of Credit | ' |
Line of Credit |
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On July 14, 2011, the Company entered into a line of credit agreement with Silicon Valley Bank (the “Bank”) and, as discussed below, on July 30, 2014, the agreement was amended. The line of credit is collateralized by the Company’s pharmaceutical, Private Payor and Medicare receivables. As of September 30, 2014, the maximum amount the Company can draw from the line of credit was $2,000,000 calculated as the lesser of (i) the Company’s calculated borrowing base, which was 80% of certain of the Company’s accounts receivable, or (ii) the amount available under the credit line. The interest rate charged to the Company was 5% through July 2014 and was 5.5% from August 2014 through September 2014. As needed from time to time, the Company may draw on this line to use for general corporate purposes. As of December 31, 2013 and September 30, 2014, the Company had drawn $1,000,000 and $1,500,000, respectively, against the line of credit. The line of credit is subject to various financial covenants. At September 30, 2014, the Company was in compliance with the covenants. Historically, however, the Company has been out of compliance with the covenants from time to time, and the Company has received waivers and forbearance agreements from the Bank. |
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As of December 31, 2013, the line of credit under the credit agreement was classified as a non-current liability on the accompanying condensed consolidated balance sheets as the line of credit had a maturity date of March 7, 2015, which was greater than one year from the date of the balance sheet. As of September 30, 2014, the line of credit under the credit agreement was classified as a non-current liability because the Waiver and Sixth Amendment to Loan and Security Agreement extended the maturity of the facility to July 25, 2016. |
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From time to time, the Company’s calculated borrowing base under its Bank line of credit may decrease to a level where the Company is in an over-advance position in which case the Company will be required to repay any outstanding amounts greater than the calculated borrowing base for such covered period back to the Bank immediately. The Company will be able to draw down on the credit line again with respect to such paid back amount once the Company is in compliance with the borrowing base requirement. |
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On July 30, 2014, in connection with entering into a credit agreement with SWK Funding LLC discussed below, the Company and the Bank entered into a Waiver and Sixth Amendment to Loan and Security Agreement (the “Sixth Amendment”). The Sixth Amendment waived previous defaults under the loan agreement, modified the financial covenants, extended the maturity of the loan to July 25, 2016, modified the interest rate to the prime rate published by the Wall Street Journal plus 2.25% per annum, and implemented a pre-payment fee of $40,000. At September 30, 2014, the interest rate charged to the Company was 5.5%. The financial covenants under the Sixth Amendment include a revenue covenant and a liquidity covenant that conform with and are cross defaulted with the revenue covenant and liquidity covenant of the SWK Credit Agreement. The Company will pay a closing fee of $10,000 for the Sixth Amendment on July 18, 2015, approximately one year from the date of the closing. |
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SWK Term Loan | ' |
SWK Term Loan |
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On July 30, 2014 (the “Closing Date”), the Company entered into a credit agreement (the “SWK Credit Agreement”) with SWK Funding LLC, as the administrative agent (the “Agent” or “SWK”), and the lenders (including SWK) party thereto from time to time (the “Lenders”). The SWK Credit Agreement provides for a multi-draw term loan to the Company (the “Loan”) up to a maximum principal amount of $12,000,000 (the “Loan Commitment Amount”). On the Closing Date, the Lenders advanced the Company an amount equal to $8,500,000 which is due and payable on July 30, 2020 (the “Term Loan Maturity Date”) or such earlier date on which the Loan Commitment Amount is terminated pursuant to the terms of the SWK Credit Agreement. |
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The Loan bears interest at a rate equal to the LIBOR Rate (as defined in the SWK Credit Agreement) plus an applicable margin of 12.5% per annum, subject to a one percent (1.0%) LIBOR floor. Interest on the Loan is due and payable in arrears (i) on the forty-fifth (45th) day following the last calendar day of each of the months of September, December, March, and June, commencing on November 15, 2014, (ii) upon a prepayment of the Loan and (iii) on the Term Loan Maturity Date. At September 30, 2014, the interest rate charged to the Company was 13.5%. Upon the earlier of (a) the Term Loan Maturity Date or (b) full repayment of the Loan, the Company is also required to pay an exit fee. On September 9, 2014, SWK, in its capacity as the initial Lender, assigned part of its interests under the SWK Credit Agreement to SG-Financial, LLC (“SG”). Pursuant to the assignment, SG was assigned $2,500,000 of the $8,500,000 Closing Date initial advance to the Company and $1,029,412 of the subsequent term loan commitment. Pursuant to the assignment, as of the effective date of the assignment, SG is a party to the SWK Credit Agreement as a Lender. |
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In addition, on the Closing Date, the Company issued to the Agent a warrant (the “Initial Warrant”) to purchase up to 681,090 shares of the Company's common stock. The Initial Warrant is exercisable, in whole or in part and from time to time, from the date of issuance until and including July 30, 2020 at an exercise price of $0.936 per share, subject to adjustment. The Initial Warrant was valued at $414,239, or approximately $0.61 per covered share, using a Black-Scholes pricing model with the following assumptions: 2.01% risk free rate, 0% dividend, 101.5% volatility, and six-year expected life. The value of the warrant was recorded on the balance sheet as discussed below. On September 9, 2014, the Agent assigned a portion of the Initial Warrant consisting of the right to purchase 200,321 shares of common stock to SG-Financial, LLC. |
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For accounting purposes, the proceeds received in the transaction were allocated to the liability for debt, a debt issuance discount and additional paid-in capital for the warrant based upon the relative fair value of the loan and the warrant. The amounts recorded in the financial statements were $8,500,000 for loan liability, $576,161 for debt issuance discount and $377,140 to additional paid-in capital for the warrant. Additionally, the Company recorded deferred loan issuance costs of $187,092 for investment banker fees and legal fees incurred to enter into the SWK Credit Agreement. The debt issuance discount and the deferred issuance costs are being amortized to interest expense over the six-year term of the loan. |
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The remaining $3,500,000 of the Loan Commitment Amount (the “Subsequent Term Loan”) may be advanced to the Company upon written request to the Agent during the period beginning on the Closing Date and ending February 28, 2016 provided that (i) no default or event of default has occurred or is continuing under the SWK Credit Agreement, (ii) the aggregate revenue recognized by the Company and any of its subsidiaries during any period of four (4) consecutive fiscal quarters ending prior to December 31, 2015 exceeds a certain dollar amount threshold and (iii) the Agent has received an executed warrant (the “Subsequent Term Loan Warrant”) to purchase a number of shares of common stock equal to the number obtained when the principal amount of the Subsequent Term Loan is multiplied by 7.5% and the product is divided by the exercise price of such warrant. The exercise price of the Subsequent Term Loan Warrant will be equal to 1.2 times the lower of (a) the average closing price of the common stock on the previous 20 trading days before the closing date of the Subsequent Term Loan, or (b) the closing price of the common stock on the last trading day prior to such Subsequent Term Loan’s closing date. The Subsequent Term Loan Warrant will be exercisable for a period of six years from the closing date of the Subsequent Term Loan, subject to adjustment. Upon issuance, the Agent may exercise the Subsequent Term Loan Warrant on a cashless basis at any time. In the event the Lender exercises the Subsequent Term Loan Warrant on a cashless basis we will not receive any proceeds. The exercise price of the Subsequent Term Loan Warrant is subject to customary adjustments provisions for stock splits, stock dividends, recapitalizations and the like. |
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The Company may prepay the Loan, in whole or in part, upon five business days’ written notice provided that a prepayment premium is paid to the Lenders as set forth in the SWK Credit Agreement. The Company is required to prepay the Loan with any net cash proceeds received from certain types of dispositions of assets described in the SWK Credit Agreement. The Company is also required to make certain revenue-based payments on the Company’s quarterly revenues, applied in the following priority: (i) first, to the payment of all fees, costs, expenses and indemnities due and owing to the Agent under the SWK Credit Agreement, (ii) second, to the payment of all fees, costs, expenses and indemnities due and owing to the Lenders under the SWK Credit Agreement, (iii) third, to the payment of all accrued but unpaid interest until paid in full, (iv) fourth, for each revenue-based payment date after August 2016, to the payment of all principal of the Loan up to an aggregate amount of $750,000 on any such payment date and (v) fifth, all remaining amounts to the Company. |
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The SWK Credit Agreement contains customary affirmative and negative covenants for credit facilities of its type, including covenants that limit the Company’s ability to pay dividends or redeem outstanding equity interests, incur additional indebtedness, grant additional liens, engage in any other type of business, make investments, merge, consolidate or sell all or substantially all of its assets and enter into transactions with related parties. The SWK Credit Agreement also contains certain financial covenants, including certain minimum aggregate revenue requirements. |
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The SWK Credit Agreement includes customary events of default, including failure to pay principal, interest or fees when due, failure to comply with covenants, default under certain other indebtedness, certain insolvency or bankruptcy events, the occurrence of certain material judgments, the institution of any proceeding by a government agency or a change of control of the Company that it is not otherwise permitted under the SWK Credit Agreement. |
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Income Taxes | ' |
Income Taxes |
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Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. |
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ASC 740, Income Taxes, clarifies the accounting for uncertainty in income taxes recognized in financial statements and requires the impact of a tax position to be recognized in the financial statements if that position is more likely than not of being sustained by the taxing authority. As of December 31, 2013 and September 30, 2014, the Company does not have a liability for unrecognized tax benefits. The Company recognizes interest and penalties associated with tax matters as part of the income tax provision and includes accrued interest and penalties with the related tax liability in the balance sheet. For the periods ended September 30, 2013 and 2014, nominal amounts of interest and penalties were recorded in the Condensed Consolidated Statement of Operations. |
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Stock-Based Compensation | ' |
Stock-Based Compensation |
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The Company accounts for stock-based compensation in accordance with ASC 718, Stock Compensation, Share-Based Payment. Stock-based compensation expense for all stock-based compensation awards granted is based on the grant-date fair value estimated in accordance with the provisions of ASC 718. The Company recognizes these compensation costs on a straight-line basis over the requisite service period of the award, which is generally the option vesting period. |
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The Company accounts for equity instruments issued to non-employees in accordance with ASC 505, Equity. Under ASC 505, stock option awards issued to non-employees are measured at fair value using the Black-Scholes option-pricing model and recognized pursuant to a performance model. |
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Management Estimates | ' |
Management Estimates |
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The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates in these condensed consolidated financial statements have been made for revenue, allowances for doubtful accounts, impairment of long-lived assets, depreciation of property and equipment and stock-based compensation. Actual results could differ materially from those estimates. |
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Long-lived Assets | ' |
Long-lived Assets |
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Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates potential impairment by comparing the carrying amount of the asset with the estimated undiscounted future cash flows associated with the use of the asset and its eventual disposition. Should the review indicate that the assets cost is not recoverable, the carrying value of the asset would be reduced to its fair value, which is measured by future discounted cash flows. |
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Foreign Currency Translation | ' |
Foreign Currency Translation |
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The financial position and results of operations of the Company’s foreign subsidiary are determined using local currency as the functional currency. Assets and liabilities of these operations are translated at the exchange rate in effect at each period-end. Statement of Operations amounts are translated at the average rate of exchange prevailing during the period. Translation adjustments arising from the use of differing exchange rates from period to period are included in accumulated other comprehensive loss in stockholders’ equity. |
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Comprehensive Loss | ' |
Comprehensive Loss |
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The components of comprehensive loss are accumulated net loss and unrealized foreign currency translation adjustments for the three and nine months ended September 30, 2013 and 2014. |
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Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments |
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Cash and cash equivalents are stated at cost, which approximates fair market value. Cash equivalents consist of money market accounts, with fair values estimated based on quoted market prices. Debt balances are stated at historical amounts less principal payments, which approximate fair market value. The Company believes interest rates in its debt agreements are commensurate with lender risk profiles for similar companies. |
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Advertising Costs | ' |
Advertising Costs |
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The Company markets its services through its advertising activities in trade publications and on the internet. Advertising costs are included in selling and marketing expenses on the statements of operations and are expensed as incurred. Advertising costs for the three months ended September 30, 2013 and 2014 were $10,924 and $26,979, respectively, and for the nine months ended September 30, 2013 and 2014 were $14,247 and $53,239, respectively. |
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Concentration of Credit Risk and Clients and Limited Suppliers | ' |
Concentration of Credit Risk and Clients and Limited Suppliers |
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Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. The Company has never experienced any losses related to these balances. At September 30, 2014, the Company had $5,826,536 in cash and cash equivalents that exceeded federally insured limits. At September 30, 2014, $11,838 of cash was held outside of the United States. |
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Revenue sources that account for greater than 10 percent of total revenue are provided below. |
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| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2013 | | | 2014 | | | 2013 | | | 2014 | |
| | (Unaudited) | | | (Unaudited) | |
| | | | Percent | | | | | Percent | | | | | Percent | | | | | Percent | |
| | | | of Total | | | | | of Total | | | | | of Total | | | | | of Total | |
| | Revenue | | Revenue | | | Revenue | | Revenue | | | Revenue | | Revenue | | | Revenue | | Revenue | |
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GlaxoSmithKline entities: | | | | | | | | | | | | | | | | | | | | | | | | |
GlaxoSmithKline, LLC | | $ | 76,792 | | * | % | | $ | 165,169 | | * | % | | $ | 579,606 | | * | % | | $ | 165,169 | | * | % |
GlaxoSmithKline Biologicals S.A. | | | 633,543 | | 16 | | | | 296,250 | | * | | | | 3,166,288 | | 21 | | | | 1,017,406 | | * | |
Total GlaxoSmithKline entities | | $ | 710,335 | | 17 | | | $ | 461,419 | | 10 | | | $ | 3,745,894 | | 25 | % | | $ | 1,182,575 | | * | |
Medicare, net of contractual allowances | | $ | 956,716 | | 23 | % | | $ | 857,786 | | 19 | % | | $ | 3,379,405 | | 23 | % | | $ | 3,378,203 | | 27 | % |
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* Represents less than 10% of revenue. |
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Customers that account for greater than 10 percent of gross accounts receivable are provided below. |
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| | As of December 31, 2013 | | | As of September 30, 2014 | | | | | | | | | | | |
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| | | | Percent of | | | | | Percent of | | | | | | | | | | | |
| | Receivable | | Total | | | Receivable | | Total | | | | | | | | | | | |
| | Balance | | Receivables | | | Balance | | Receivables | | | | | | | | | | | |
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GlaxoSmithKline entities: | | | | | | | | | | | | | | | | | | |
GlaxoSmithKline LLC | | $ | 597,937 | | | * | % | | $ | 145,654 | | | * | % | | | | | | | | | | |
GlaxoSmithKline Biologicals S.A. | | $ | 544,298 | | | * | % | | $ | 470,957 | | | * | % | | | | | | | | | | |
Total GlaxoSmithKline entities | | $ | 1,142,235 | | | 13 | % | | $ | 616,611 | | | * | % | | | | | | | | | | |
Medicare, net of contractual allowances | | $ | 2,422,611 | | | 28 | % | | $ | 2,377,560 | | | 26 | % | | | | | | | | | | |
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* Represents less than 10% of accounts receivable. |
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Many of the supplies and reagents used in the Company’s testing process are procured from a limited number of suppliers. Any supply interruption or an increase in demand beyond the suppliers’ capabilities could have an adverse impact on the Company’s business. Management believes it can identify alternative sources, if necessary, but it is possible such sources may not be identified in sufficient time to avoid an adverse impact on its business. The Company purchases certain laboratory supplies and reagents primarily from two suppliers. The Company made approximately 87% of its reagent purchases from three suppliers during the three months ended September 30, 2013 and made approximately 76% of its reagent purchases from three suppliers during the three months ended September 30, 2014. The Company made approximately 90% of its reagent purchases from four suppliers during the nine months ended September 30, 2013 and made approximately 69% of its reagent purchases from two suppliers during the nine months ended September 30, 2014. |
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Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which modifies how all entities recognize revenue, and consolidates into one Accounting Standards Codification ("ASC") Topic (ASC Topic 606, Revenue from Contracts with Customers) the current guidance found in ASC Topic 605, Revenue Recognition, and various other revenue accounting standards for specialized transactions and industries. The core principle of the guidance is that “an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.” In achieving this objective, an entity must perform five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations of the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU 2014-09 also clarifies how an entity should account for costs of obtaining or fulfilling a contract in a new ASC Subtopic 340-40, Other Assets and Deferred Costs – Contracts with Customers. |
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ASU 2014-09 is effective for public companies for annual periods beginning after December 15, 2016 and interim periods within those annual periods, and early adoption is not permitted. ASU 2014-09 may be applied using either a full retrospective approach, in which all years included in the financial statements are presented under the revised guidance, or a modified retrospective approach. Under the modified retrospective approach, financial statements will be prepared using the new standard for the year of adoption, but not for prior years. Under this method, entities will recognize a cumulative catch-up adjustment to the opening balance of retained earnings at the effective date for contracts that still require performance by the company and disclose all line items in the year of adoption as if they were prepared under the old revenue guidance. We will adopt ASU 2014-09 on January 1, 2017 and are currently evaluating the impact that this adoption will have on our consolidated financial statements. At this time, the Company has not determined the transition method that will be used. |
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In August 2014, the Financial Accounting Standards Board issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (“ASU 2014-09”). ASU 2014-15 provides guidance on management's responsibility in evaluating whether there is substantial doubt about a company's ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company's ability to continue as a going concern within one year from the date the financial statements are issued. ASU 2014-15 is effective for annual periods ending after December 15, 2016, and interim periods thereafter; earlier adoption is permitted. The Company has not yet determined the impact of this guidance on the Company's consolidated financial statements |
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Royalty Agreements [Member] | ' |
Significant Accounting Policies [Line Items] | ' |
License Fees | ' |
License Fees |
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The Company licenses technology for the extraction of RNA and DNA from FFPE tumor specimens from the University of Southern California (“USC”) in exchange for royalty fees on revenue generated by use of the technology. These royalties are calculated as a fixed percentage of net sales price as defined in the agreement that we generate from use of the technology licensed from USC. We also maintain a non-exclusive license to use Roche Molecular Systems, Inc.’s (“Roche”) PCR, homogenous PCR, and reverse transcription PCR processes. We pay Roche a fixed percentage royalty fee for revenue that we generate through use of this technology. |
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The Company is subject to potentially significant variations in royalties recorded in any period. While the amount paid is based on a fixed percentage of net sales price as defined in the agreement of specific tests pursuant to terms set forth in the agreements with USC and Roche, the amount due is calculated based on the revenue we recognize using the respective licensed technology. As discussed above, this revenue can vary from period to period as it is dependent on the timing of the specimens submitted by our clients for testing. |
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Additionally, the Company periodically analyzes the technical procedures performed in its test offerings to assess which activities utilize licensed technologies and to calculate royalties for use of the licensed technology. Based upon the most recent analyses, the Company reduced the accrued liability during the quarter ended September 30, 2014 to an amount that management believes represents the amounts due under the USC license agreement. Management believes the accrued liability could be further revised in future periods based upon interactions with licensors. |
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