Accounting Changes and Error Corrections [Text Block] | 2. Restatement of the Financial Statements This Note 2 to the Company’s financial statements discloses the impact on the restated financial statements for the year ended December 31, 2014 and the nature and derivation of the associated adjustments. The impact of the restatement on interim periods in 2014 is described in Note 16 (unaudited). The corrections contained in these restated financial statements are referred to herein as the “Restatement.” See also “Revision of the Prior Period Financial Statements” in this Note 2 for a description of certain immaterial errors in the years ended December 31, 2013, 2012 and 2011. Restatement Background As previously described in the Company’s Current Report on Form 8-K filed on March 15, 2015, the Audit Committee, in consultation with management, concluded that the Company’s unaudited interim and audited annual financial statements previously issued for 2014 and its unaudited interim financial statements previously issued for the three and nine months ended September 30, 2015 should not be relied upon due to errors identified in such financial statements related to the timing of revenue recognition under contracts with distributors. In the Company’s Current Report on Form 8-K filed on November 20, 2015, the Company previously disclosed its conclusion that its unaudited interim financial statements for the quarters ended March 31, 2015 and June 30, 2015 should not be relied upon for similar reasons. The corrections contained in these restated financial statements were prepared following an independent review by the Audit Committee (the “Audit Committee”) of the Company’s Board of Directors into certain accounting matters (the “Independent Review”) as described in the Explanatory Note. Impact of the Restatement Based on the Independent Review, the Audit Committee concluded, among other things, that there were both material and immaterial misstatements in the financial statements for the year ended December 31, 2014. The correction of these material and other immaterial errors decreased product revenue by $9.0 million for the year ended December 31, 2014. The correction of these errors decreased net income for the year ended December 31, 2014 by $8.2 million. The primary material errors corrected in the restatement relate to recognition of revenue under distributor sales arrangements and valuation of inventory. Recognition of revenue under distributor sales arrangements Based on the Audit Committee’s Independent Review, the Company determined that it had erred in its application of GAAP with respect to the recognition of revenue arising from the two types of distributor sales arrangements described below: 1. Certain distributor sales did not meet the criteria for recognizing revenue in 2014 . During 2014, the Company provided unusually long payment terms to two distributors that were affiliated with each other. Granting a customer unusually long payment terms can cause the related sales transactions to fail the “fixed and determinable” criteria required under GAAP to recognize revenue. Also, for one sales transaction to a third distributor in the fourth quarter of 2014, the Company determined that evidence existed which suggests that an arrangement under GAAP did not exist in 2014. Accordingly, revenue arising from these transactions did not meet the criteria for recognizing revenue under GAAP in 2014. Correction of these errors decreased 2014 revenue by $10.3 million and decreased trade accounts receivable as of December 31, 2014 by the same amount. Net of product costs and sales commission expenses arising from these transactions, correction of these errors decreased 2014 net income by $5.6 million. Under GAAP, the $10.3 million revenue reversed in 2014 may be recognized in a future period on an accrual basis upon meeting the criteria for revenue recognition or, if such criteria is not met, on a cash basis, upon receipt of payment from the customer. 2. Sales through government contracting agent . The Company utilizes a government contracting agent through which it sells to facilities of the United States Department of Veterans Affairs and the United States Department of Defense under the agent’s GSA Federal Supply Schedule. The Company erred in reporting revenue from such sales net of the agent’s fees, although GAAP (and the Company’s policy) requires that revenue arising from contractual arrangements of this type be reported at the gross price paid by the end user, and that the related fees be reported as a sales expense. Correction of this error, with respect to these sales, increased both 2014 sales and marketing expenses and product revenue by $1.5 million and, accordingly, had no impact on net income. Taken together, correction of the errors arising from these two types of distributor sales arrangements decreased 2014 product revenue by $8.8 million (consisting of a $10.3 million decrease described in paragraph (1) above offset by a $1.5 million increase described in paragraph (2) above). In addition, the Company corrected other revenue accounting errors unrelated to distributor sales arrangements which decreased 2014 product revenue by an additional $241,000. As a result, the correction of errors in the Restatement decreased 2014 product revenue by a total $9.0 million Consistent with corrections in the Company’s recognition revenue, the product costs arising from the distributor sales transactions for which revenue has been reversed have also been reversed and added back to inventory. As a result of such corrections, inventory as of December 31, 2014 increased by $852,000 and the cost of product revenue for the year then ended decreased by the same amount. Similarly, sales commission expenses incurred during 2014 in connection with the distributor sales transactions for which revenue has been reversed have also been reversed. As a result of such corrections, prepaid expenses increased by $2.2 million, with respect to such expenses paid during 2014, and accrued expenses decreased by $1.5 million, with respect to commissions unpaid and accrued as of December 31, 2014, while 2014 sales and marketing expenses decreased by $3.8 million. Valuation of inventory and accounting for consigned inventory quantities Management determined that there were errors in the valuation of the Company’s finished goods inventory resulting from computational errors, failure to update and apply current cost information in the calculation of unit costs, and non-timely identification and write-off of products that were no longer salable as determined by the Company’s quality assurance procedures. In addition, management determined the need to establish a reserve for consigned finished goods inventory as the Company had not adequately monitored the ultimate disposition of consigned goods whereby some were returned, or scrapped, or used by the consignee. Lastly, management determined the need to establish a reserve for work-in-process inventory which largely consists of product in quarantine pending the outcome of the Company’s quality assurance procedures. This process results in a reasonably consistent identification of product that is unsalable. Correction of these errors, to write-down the value of inventory as of December 31, 2014, increased 2014 cost of revenue and decreased 2014 net income by $2.0 million. Bad debt reserve Management determined that it did not correctly assess the collectability of accounts receivable and determined an appropriate allowance for doubtful accounts as of December 31, 2014. Correction of this error, by increasing its 2014 bad debt expenses and allowance for doubtful accounts as of December 31, 2014, increased the Company's 2014 general and administrative expenses by approximately $450,000 and reduced its accounts receivables as of December 31, 2014 by the same amount. Classification of costs and expenses to income statement captions Management determined that errors had been made in classification of costs and expenses to income statement captions. Correction of these errors reduced 2014 cost of product revenue and research and development expenses by $4.1 million and $3.6 million, respectively, and increased sales and marketing and general and administrative expenses by $7.6 million and $134,000, respectively. Other adjustments In addition to the error corrections mentioned above, adjustments were made to the financial statements for various immaterial errors identified by management and the Audit Committee during the course of the restatement process. The net impact of such adjustments was to decrease net income by $507,000 for the year ended December 31, 2014. Tax effect of restatement adjustments The Company reduced 2014 income tax expense by $585,000 to account for the impact of the adjustments in the Restatement described above. The financial reporting impact of the error correction adjustments described above is as follows: Year ended December 31, 2014 (a) Revenue Recognition Error Corrections Net Income Stockholders' (in thousands) Impact Equity Impact Product revenue $ $ — Cost of product revenue — Sales and marketing expenses — Trade accounts receivable — Inventory — Prepaids and other current assets — Accounts payable and accrued expenses — Net (decrease)/increase $ $ Year ended December 31, 2014 (b) Inventory Valuation Error Corrections Net Income Stockholders' (in thousands) Impact Equity Impact Cost of product revenue $ $ — Inventory — Net (decrease)/increase $ $ Year ended December 31, 2014 (c) Bad Debt Reserve Net Income Stockholders' (in thousands) Impact Equity Impact General and administrative expenses $ $ — Trade accounts receivable — Net (decrease)/increase $ $ Year ended December 31, 2014 (d) Expense Caption Classification Error Corrections Net Income Stockholders' (in thousands) Impact Equity Impact Cost of product revenue $ $ — Research and development expenses — Sales and marketing expenses — General and administrative expenses — Net (decrease)/increase $ — $ — Year ended December 31, 2014 (e) Other Immaterial Error Corrections Net Income Stockholders' (in thousands) Impact Equity Impact Cost of product revenue $ $ — Research and development expenses — Sales and marketing expenses — General and administrative expenses — Related party fees — Income tax expense — Other receivables — Property and equipment — Accounts payable and accrued expenses — Additional paid-in capital — Beginning retained earnings — Net (decrease)/increase $ $ Year ended December 31, 2014 (f) Tax effect of restatement adjustments Net Income Stockholders' (in thousands) Impact Equity Impact Income tax expense $ $ — Loss from discontinued operations — Other receivables — Accounts payable and accrued expenses — Additional paid-in capital — Net (decrease)/increase $ $ Year ended December 31, 2014 Summary of Restatement Adjustments Net Income Stockholders' Restatement (in thousands) Impact Equity Impact Ref Product revenue $ $ — (a) Cost of product revenue — (a), (b), (d), (e) Research and development expenses — (d), (e) Sales and marketing expenses — (a), (d), (e) General and administrative expenses — (c), (d), (e) Related party fees — (e) Income tax expense — (e), (f) Loss from discontinued operations — (f) Trade accounts receivable — (a), (c) Other receivables — (e), (f) Inventory — (a), (b) Prepaids and other current assets — (a) Property and equipment — (e) Accounts payable and accrued expenses — (a), (e), (f) Additional paid-in capital — (e), (f) Beginning retained earnings — (e) Net (decrease)/increase $ $ The following table presents the effects of the Restatement on the Company’s Balance Sheet as of December 31, 2014. December 31, 2014 (Previously Restatement 2014 Restatement (in thousands, except per share data) Reported) Adjustments (Restated) Ref Assets Current assets: Cash $ $ — $ Investments available for sale — Trading securities — Trade accounts receivable, net of reserves (a), (c) Other receivables (e), (f) Inventory (a), (b) Prepaid expenses and other current assets (a) Total current assets Property and equipment, net (e) Other assets — Total assets $ $ $ Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued expenses $ $ $ (a), (e), (f) Capital lease obligations, current portion — Deferred exclusivity fee revenue, current portion — Total current liabilities Other long-term liabilities — Total liabilities Commitments and contingencies Stockholders' equity Common stock, $.001 par value, 90,000 shares authorized, 34,346 shares outstanding — Additional paid-in-capital (e), (f) Accumulated other comprehensive loss — Accumulated deficit Total stockholders' equity Total liabilities and stockholders' equity $ $ $ The following table presents the effects of the Restatement on the Company’s Statement of Comprehensive Income (Loss) for the year ended December 31, 2014. Year ended December 31, 2014 (Previously Restatement 2014 Restatement (in thousands, except per share data) Reported) Adjustments (Restated) Ref Product revenue $ $ $ (a) Cost of product revenue (a), (b), (d), (e) Gross profit Operating expenses Research and development (d), (e) Sales and marketing (a), (d), (e) General and administrative (c), (d), (e) Fees paid to related parties (e) Share based payments to related parties — Total operating expenses Income (loss) from operations Other (expense) income, net — Loss from continuing operations, before income taxes Income tax (expense) benefit (e), (f) Loss from continuing operations Discontinued operations Loss from operations of discontinued operations, net of income taxes of $516 in 2014 (f) (Loss) income from discontinued operations Net (loss) income Other comprehensive loss Unrealized loss on investments available for sale — Comprehensive (loss) income $ $ $ Basic and diluted loss per share Loss from continuing operations $ $ $ Loss from discontinued operations Basic and diluted loss per share $ $ $ Weighted average common shares (basic and diluted) The following table presents the effects of the Restatement on the Company’s Statement of Cash Flows for the year ended December 31, 2014. Year ended December 31, 2014 (Previously Restatement 2014 Restatement (in thousands) Reported) Adjustments (Restated) Ref Cash flows from operating activities: Continuing operations Loss from continuing operations $ $ $ Adjustments to reconcile loss from continuing operations to net cash used in operations of continuing operations: Unrealized loss on trading securities — Depreciation and amortization — Non cash share-based payments (e) Provision for bad debts (c) Changes in operating assets and liabilities: Accounts receivable (a) Inventory (a), (b) Prepaid expenses, and other current assets (a), (e) Tax receivable — (f) Other assets — Accounts payable, accrued expenses, and other liabilities (a), (e), (f) Net cash used in operating activities of continuing operations Discontinued operations Loss from discontinued operations (f) Adjustments to reconcile loss from discontinued operations to net cash used in operations of discontinued operations: Expiration of price protection derivative related to trading securities — Changes in operating assets and liabilities: Accounts receivable and other current assets — Accounts payable and accrued expenses — Net cash provided by operations of discontinued operations Net cash used in operating activities Cash flows from investing activities: Purchases of property and equipment (e) Proceeds from sale of investments available for sale — Purchases of investments available for sale — Net cash provided by investing activities Cash flows from financing activities: Principal payments on capital lease obligations — Restricted cash — Proceeds from the exercise of options to purchase common stock — Windfall benefit from stock-based compensation Net cash provided by financing activities Net (decrease) in cash — Cash at beginning of period — Cash at end of period $ $ — $ Supplemental disclosure of cash flows information: Cash paid for income taxes $ $ — $ Supplemental disclosure of non cash activities: Deferred compensation related to Stryker agreement — Guaranteed payment related to trading securities — Unrealized loss on investments available for sale — Revision of Prior Period Financial Statements In addition to the correction of the errors in 2014 in the Restatement described above, the Company also corrected certain immaterial errors in its financial statements for years ended December 31, 2013, 2012 and 2011 contained herein. In accordance with ASC 650-10-S99 and S55 (formerly Staff Accounting Bulletins (“SAB”) No. 99 and No. 108), Accounting Changes and Error Corrections , the Company concluded that these errors were, individually, and in the aggregate, not material, quantitatively or qualitatively, to the financial statements in these periods. The adjustments to correct the immaterial errors only had an impact on certain captions within the comprehensive statement of income (loss) and balance sheets as set forth below. For year ended December 31, 2013 2012 2011 Net Income Stockholders' Net Income Stockholders' Net Income Stockholders' (in thousands) Impact Equity Impact Impact Equity Impact Impact Equity Impact Revenue Recognition Product revenue $ $ — $ $ — $ $ — Cost of product revenue — — — Sales and marketing expenses — — — — — Deferred revenue — — — Inventory — — — Directors' Expenses Other receivables — — — — Fees paid to related parties — — — — Tax Effect of the Adjustments Income taxes benefit — — — — — Income from discontinued operations — — — — — Net increase/(decrease) $ $ $ $ $ $ Adjustments related to periods prior to January 1, 2012 are reflected as an adjustment to beginning retained earnings for the year ended December 31, 2012. The immaterial errors to product revenue in the table above were identified during the Independent Review and relate to a type of distributor sales arrangement under which the distributor agrees to be billed in advance of the Company’s shipment of ordered products, commonly referred to as “bill and hold” arrangements. Historically, the Company had recognized product revenue upon shipment provided a purchase order or other documentation evidencing the customer’s acceptance of the risks of ownership had been received before shipment, or upon receipt of notification of product use (implantation) if no such documentation was provided in advance. However, a limited number of distributor sales transactions in 2012 and 2011 were accounted for as bill and hold arrangements, which were initially deemed to qualify under GAAP for revenue recognition upon invoicing of the customer even though shipment was expected to take place at an unspecified future date. In the Independent Review, the Audit Committee determined that these transactions had failed to meet all of the GAAP criteria required to recognize revenue in advance of shipment and concluded that recognition of such revenue should be reversed and recognized in a subsequent period when the product had been shipped to the distributors or their end-use (clinical provider) customers. Correction of these errors, to recognize revenue when the shipment is completed, decreased 2012 and 2011 revenue by $685,000 and $262,000, respectively. Recognition of such revenue upon completion of shipment increased 2013 revenue by $947,000. Net of product costs arising from these transactions, correction of these errors decreased 2012 and 2011 net income by $554,000 and $198,000, respectively, and increased 2013 net income by $752,000. The Company utilizes a government contracting agent through which it sells to the United States Department of Veterans Affairs and the United States Department of Defense facilities under the agent’s GSA Federal Supply Schedule. The Company erred in reporting revenue from such sales net of the agent’s contracting fees, although GAAP (and the Company’s policy) requires that revenue arising from contractual arrangements of this type be reported at the gross price paid by the end user, and that the related fees be reported as a sales expense. Correction of this error, with respect to these sales, increased both 2013 sales and marketing expenses and product revenue by $443,000 and, accordingly, had no impact on net income. The Company has also recorded adjustments reducing related party expenses by $70,000 and $34,000 for the years ended December 31, 2013 and 2012, respectively, which represent the amounts of expenses that the Audit Committee determined should not have reimbursed to the Chairman of the Board in those years. See Note 10, Related Party Transactions and Warrant, for more details. The following table presents the effects of the revision of the Company’s previously issued Balance Sheet as of December 31, 2013. December 31, 2013 (Previously 2013 (in thousands, except per share data) Reported) Adjustments (Revised) Assets Current assets: Cash $ $ — $ Investments available for sale — Trading securities — Trade accounts receivable, net of reserves — Other receivables Inventory — Prepaid expenses and other current assets — Current assets of discontinued operations — Total current assets Property and equipment, net — Deferred tax asset — Restricted cash — Total assets $ $ $ Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued expenses $ $ — $ Capital lease obligations, current portion — Deferred exclusivity fee revenue, current portion — — — Deferred tax liability — Current liabilities of discontinued operations — Total current liabilities — Other long-term liabilities — Total liabilities — Commitments and contingencies Stockholders' equity Common stock, $.001 par value, 90,000 shares authorized, 34,115 shares outstanding — Additional paid-in-capital — Accumulated other comprehensive loss — Accumulated deficit Total stockholders' equity Total liabilities and stockholders' equity $ $ $ The following table presents the effects of the revision of the Company’s previously issued Statement of Comprehensive Income (Loss) for the year ended December 31, 2013. Year ended December 31, 2013 (Previously 2013 (in thousands, except per share data) Reported) Adjustments (Revised) Product revenue $ $ $ Cost of product revenue Gross profit Operating expenses: Research and development — Sales and marketing General and administrative — Fees paid to related parties — Share based payments to related parties — Total operating expenses Income (loss) from operations Other income, net — Loss from continuing operations, before income taxes Income tax (expense) benefit Loss from continuing operations Discontinued operations: Loss from operations of discontinued operations, net of income taxes of $0 — Gain from sale of discontinued operations, net of income taxes of $1,374 in 2013 Income from discontinued operations Net income Other comprehensive loss Unrealized loss on investments available for sale — Comprehensive income $ $ $ Basic and diluted income (loss) per share Income (loss) from continuing operations $ $ $ Income (loss) from discontinued operations — Basic and diluted income (loss) per share $ $ $ Weighted average common shares (basic and diluted) The following table presents the effects of the revision of the Company’s previously issued Statement of Cash Flows for the year ended December 31, 2013. Year ended December 31, 2013 (Previously 2013 (in thousands) Reported) Adjustments (Revised) Cash flows from operating activities: Continuing operations Loss from continuing operations $ $ $ Adjustments to reconcile loss from continuing operations to net cash used in operations of continuing operations: Unrealized gain on trading securities — Depreciation and amortization — Non cash share-based payments — Provision for bad debts — Changes in operating assets and liabilities: Accounts receivable — Inventory Prepaid expenses, and other current assets Tax Receivable — Other assets — — — Deferred revenue — Accounts payable, accrued expenses, and other liabilities — Net cash used in operating activities of continuing operations Discontinued operations Loss from discontinued operations — Adjustments to reconcile loss from discontinued operations to net cash used in operations of discontinued operations: Expiration of price protection derivative related to trading securities — Depreciation and amortization — Non cash share-based payments — Changes in operating assets and liabilities: — Accounts receivable and other current assets — Accounts payable and accrued expenses — Net cash used in operations of discontinued operations — Net cash used in operating activities Cash flows from investing activities: Purchases of property and equipment — Proceeds from sale of discontinued operations, net Proceeds from sale of investments available for sale — Purchases of investments available for sale — Net cash provided by investing activities Cash flows from financing activities: Principal payments on capital lease obligations — Restricted cash — Proceeds from the exercise of options to purchase common stock — Net cash provided by financing activities — Net increase in cash — Cash at beginning of period — Cash at end of period $ $ — $ Supplemental disclosure of cash flows information: Cash paid for income taxes $ $ — $ Supplemental disclosure of non cash activities: Trading securities from the sales of discontinued operations — Purchase price guarantee related to trading securities — Proceeds receivable due from sale of discontinued operations — Unrealized loss on investments available for sale — The following table presents the effects of the revision of the Company’s previously issued Statement of Comprehensive Income (Loss) for the year ended December 31, 2012. Year ended December 31, 2012 (Previously 2012 (in thousands, except per share data) Reported) Adjustments (Revised) Product revenue $ $ $ Cost of product revenue Gross profit Operating expenses: Research and development — Sales and marketing — General and administrative — Fees paid to related parties Share based payments to related parties — Total operating expenses Loss from operations Other income, net — Loss from continuing operations, before income taxes Income tax benefit — Loss from continuing operations Discontinued operations: Loss from operations of discontinued operations, net of income taxes of $0 — Loss from discontinued operations — Net loss Other comprehensive loss Unrealized loss on investments available for sale — Comprehensive loss $ $ $ Basic and diluted loss per share Loss from continuing operations $ $ $ Loss from discontinued operations — Basic and diluted loss per share $ $ $ Weighted average common shares (basic) The following table presents the effects of the revision of the Company’s previously issued Statement of Cash Flows for the year ended December 31, 2012. Year ended December 31, 2012 (Previously Restatement 2012 (in thousands) Reported) Adjustments (Revised) Cash flows from operating activities: Continuing operations Loss from continuing operations $ $ $ Adjustments to reconcile loss from continuing operations to net cash used in operations of continuing operations: Depreciation and amortization — Non cash share-based payments — Provision for bad debts — Changes in operating assets and liabilities: Accounts receivable — Inventory Prepaid expenses, and other current assets Tax Receivable — Other assets — — — Deferred revenue — Accounts payable, accrued expenses, and other liabilities — Net cash used in operating activities of continuing operations — Discontinued operations Loss from discontinued operations — Adjustments to reconcile loss from discontinued operations to net cash used in operations of discontinued operations: Depreciation and amortization — Non cash share-based payments — Changes in operating assets and liabilities: Accounts receivable and other current assets — Accounts payable and accrued expenses — Deferred revenue — Net cash provided by (used in) operations of discontinued operations — Net cash used in operating activities — Cash flows from investing activities: Purchases of property and equipment — Proceeds from sale of investments available for sale — Purchases of investments available for sale — Net cash provided by investing activities — Cash flows from financing activities: Principal payments on capital lease obligations — Restricted cash — Proceeds from the exercise of options to purchase common stock — Net cash provided by financing activities — Net increase in cash — Cash at beginning of period — Cash at end of period $ $ — $ Supplemental disclosure of cash flows information: Cash paid for income taxes $ — $ — $ — Supplemental disclosure of non cash activities: Equipment acquired under a capital lease — Unrealized loss on investments available for sale — |