Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of Vericel and its wholly-owned subsidiaries, Marrow Donation, LLC, located in San Diego, California, and Vericel Denmark ApS, in Kastrup, Demark (collectively, the Company). All inter-company transactions and accounts have been eliminated in consolidation. Marrow Donation, LLC and Vericel Denmark ApS ceased operations in 2015. Use of Estimates The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reported period. Actual results could differ from those estimates. Consolidated Statement of Cash Flows The following table presents certain supplementary cash flows information for the years ended December 31, 2017, 2016 and 2015: Year Ended December 31, (In thousands) 2017 2016 2015 Interest paid (net of interest capitalized) $ 931 $ 226 $ — Income tax withholding paid 100 — — Inventory Inventories are measured at the lower of cost and net realizable value. Cost is calculated based upon standard-cost which approximates costs determined on the first-in, first-out method. The Company periodically reviews its inventories for excess or obsolescence and write-down obsolete or other unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated by us, or if it is determined that inventory utilization will further diminish based on estimates of demand, additional inventory write-downs may be required. In all cases, product inventory is carried at the lower of cost or its estimated net realizable value. Amounts written down are charged to cost of sales. Accounts Receivable Accounts receivable are initially recorded at the contractual amount owed by the customer. Allowances for doubtful accounts are established when the facts and circumstances indicate that a receivable may not be collectible. Property, Plant and Equipment Property, plant and equipment are initially measured and recognized at acquisition cost, including any directly attributable cost of preparing the asset for its intended use or, in the case of assets acquired in a business combination, at fair value as at the date of the combination. After initial measurement, property, plant and equipment are carried at cost less accumulated depreciation and impairment. Repair and maintenance costs of property, plant and equipment are expensed as incurred. The depreciable value of property, plant and equipment, net of any residual value, is depreciated on a straight line basis over the useful life of the asset. The useful life of an asset is usually equivalent to its economic life. The useful lives of property, plant and equipment are as follows: • Equipment and computers: 3 to 5 years • Furniture and fixtures: 5 years • Building improvements and leasehold improvements: Shorter of the remaining life of the lease or 7 years The costs of assets retired or otherwise disposed of and the accumulated depreciation thereon are removed from the accounts, with any gain or loss realized upon sale or disposal credited or charged to operations. Intangible Assets and Other Long Lived Assets Intangible assets are initially measured at acquisition cost, including any directly attributable costs of preparing the asset for its intended use or, in the case of assets acquired in a business combination at fair value as at the date of the combination. Identifiable intangible assets related to commercial rights are amortized on a straight line basis over their expected useful lives. Amortization of intangible assets is recognized in these financial statements under Costs of product sales. Intangible assets and long-lived assets are assessed for potential impairment when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. An impairment loss would be recognized when an asset’s fair value, determined based on undiscounted cash flows expected to be generated by the asset, is less than its carrying amount. The impairment loss would be measured as the amount by which the asset’s carrying value exceeds its fair value and recognized in these financial statements. Intangible assets are carried at cost less accumulated amortization and impairment. Upon the approval of MACI in December 2016 and the replacement of Carticel with MACI, it was determined that the Carticel commercial rights intangible asset was fully impaired as of December 31, 2016 resulting in a loss on intangible asset impairment of $2.6 million . The value of the intangible assets was determined using the income approach based on projected cash flows attributed to the commercial rights. Revenue Recognition and Net Product Sales Revenue from sales to a customer (distributor, hospital or other party) is recognized in accordance with ASC 605, Revenue Recognition and SAB Topic 104, R eve nue Recognition (ASC 605), when (i) persuasive evidence of an arrangement exists, (ii) the goods are shipped or delivered and implanted, depending on shipping terms, (iii) title and risk of loss pass to the customer and (iv) collectability is reasonably assured. Shipping and handling costs are included as a component of revenue. Revenue from sales where the patient is the customer and a third party payer (insurance company, etc.) pays all or some of the product price on the patient's behalf are accounted for under ASC 954-605, Health Care Entities - Revenue Recognition (ASC 954). Prior to July 1, 2016, the Company sold Carticel through a distributor and followed ASC 605, Revenue Recognition and SAB Topic 104 Revenue Recognition to record revenue. This distributor purchased and took title to Carticel upon shipment of the product and assumed credit and collection risk related to the end customers. The distributor worked with the payers on behalf of patients and surgeons to ensure medical coverage and to obtain reimbursement for Carticel implantation procedures. Under this arrangement, the distributor is the Company's customer. The Company retained responsibility for shipment of the product to the surgical suite. Revenue was recorded for Carticel upon occurrence of the surgery, net of provisions for rebates and cash discounts. Such rebates and discounts were $0.5 million for the year ended December 31, 2016. There were no material rebates or cash discounts for year ended December 31, 2017. These rebates and prompt payment cash discounts were established by the Company at the time of sale, based on actual experience adjusted to reflect known changes in the factors that impact such reserves. Adjustments to these reserves had historically not been significant. On June 30, 2016, the Company reduced the scope of the agreement with its exclusive distributor by terminating their services for a significant portion of its Carticel sales. On July 1, 2016, the Company transitioned to a direct sales model for Carticel and MACI after launch whereby the Company retained credit and collection risk from the patient as the end customer. The Company utilized a new provider, Dohmen Life Science Services, LLC (DLSS), to provide patient support services but this provider did not purchase and take title to Carticel or MACI. Under this arrangement, the patient is the Company's customer. On May 15, 2017, the Company and DLSS mutually terminated the agreement effective June 30, 2017. The Company also utilized Vital Care Inc. and its franchisees as a second provider to expand the available network of contracted third-party payers for Carticel and MACI. Under this direct sales model, the patient bears the ultimate financial responsibility for the purchase of Carticel or MACI and as such the Company recognized revenue in accordance with ASC 954-605, Health Care Entities - Revenue Recognition . The third party payer (insurance company, government, etc.) pays all or some of the product price on the patient’s behalf. Under the direct sales model, the Company recognizes product revenues from sales of Carticel and MACI upon implantation at which time the claim is billable to patient’s insurance provider on behalf of the patient and is billed by either DLSS or Vital Care. The Company assumed counterparty risk for the third party reimbursement payment from the payer and from the patient co-pay. Prior authorization or confirmation of coverage level by the patient’s private insurance plan, hospital or government payer is a prerequisite to the shipment of product to a patient. The Company's net product revenues are calculated by estimating expected payments for insurance, hospital or patient payments at the time it invoices and recognizes revenue. To support this direct sales model, the Company utilized DLSS to provide administrative services associated with case management and reimbursement support and to provide billing and collection services. The Company utilized Vital Care to provide similar billing and collection services for a subset of insurance payers and patients. In April 2017, we were was notified of a contractual dispute between Vital Care and a third-party payer and as a result, during the three months ended March 31, 2017, we increased our estimated revenue allowances, reducing revenue by $2.1 million related to 2016 sales and $0.7 million related to 2017 sales to reflect the lower reimbursement that would be obtained if the claims were ultimately required to be treated as out-of-network. In July 2017, the dispute was resolved and the negotiated reimbursement resulted in our ability to initially reduce our estimated sales allowances by $1.4 million which resulted in additional revenue in the second quarter of 2017 related to sales which originated primarily in 2016. As a result of the continuing evaluation and assessment of these expected payments, our estimates for expected payments could change. Other than this adjustment the other adjustments recorded during 2017 related to our estimation under ASC 954-605, Health Care Entities - Revenue Recognition were not significant. On May 15, 2017, the Company entered into a distribution agreement with Orsini Pharmaceutical Services, Inc. (Orsini) to appoint Orsini as a specialty pharmacy distributor of MACI to patients' physicians and other healthcare providers. The initial term of the distribution agreement will end on May 15, 2019 with the option of 2 additional two-year terms. Other Revenue Other revenue represents the amount of revenue recorded upon the license grant to Innovative Cellular Therapeutics CO., LTD. (ICT) discussed in note 15. The Company received $1.2 million from ICT for licenses and the technology for Carticel, MACI, Epicel and Ixmyelocel-T and related payments. The license grant and related arrangement is accounted for under the multiple-element arrangement guidance (arrangements with more than one deliverable). As a result, interpretation and judgment is required to determine the appropriate accounting for these transactions including how the arrangement consideration should be allocated among potential multiple deliverables and developing an estimate of the stand-alone selling price of each deliverable. For multiple-element arrangements, revenue is allocated to each unit of accounting based on their relative selling prices. Relative selling prices are based on management's best estimate of the selling price. As a result of the assessment of the fair value, the Company's estimates could impact the timing or amount of revenue recognition. In accordance with the multiple element arrangement accounting, we allocated the upfront payment from ICT to the multiple deliverables which include the license, a training obligation, and product supply. Based upon our determination of the best estimate of selling price of each of these deliverables, the majority of the upfront payment was allocated to the license. The license was delivered in December of 2017 and as such revenue of $1.2 million was recorded in 2017. Research and Development Expense Research and development activities represent a significant part of the Company’s business. These expenditures relate to the development of new products, improvement of existing products, technical support of products and compliance with governmental regulations for the protection of consumers and patients. Research and development expenses are expensed as incurred. Stock-Based Compensation The Company’s accounting for stock-based compensation requires it to determine the fair value of common stock issued in the form of stock option awards. The Company uses the value of its common stock at the date of the grant in the calculation of the fair value of its share-based awards. The fair value of stock options held by the employees is determined using a Black-Scholes option valuation method, which is a valuation technique that is acceptable for share-based payment accounting. Key assumptions in determining fair value include volatility, risk-free interest rate, dividend yield and expected term. The assumptions used in calculating the fair value of stock options represent the Company’s best estimates, however; these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the stock-based compensation expense could be materially different in the future. In addition, the Company estimates the expected forfeiture rate and only recognize expense for those stock options expected to vest over the service period. The estimated forfeiture rate considers the historical experience of the Company’s stock-based awards. If the actual forfeiture rate is different from the estimate, expense is adjusted accordingly. The Company also has an Employee Stock Purchase Plan (ESPP) which is a compensatory plan. Compensation expense is recorded based on the fair value of the purchase options at the grant date, which corresponds to the first day of each purchase period, and is amortized over the purchase period. Comprehensive Loss Comprehensive loss is the change in common stockholders’ equity during a period arising from any gain or loss realized related to foreign currency translation. Since 2015, when we ceased operations in Denmark, foreign currency translation has been recognized in the statement of operations. As a result there are no remaining differences between net loss and comprehensive loss for 2017 and 2016. Income Taxes Deferred tax assets are recognized for deductible temporary differences and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The Company records uncertain tax positions in the financial statements only if it is more likely than not that the uncertain tax position will be sustained upon examination by the taxing authorities. The Company records interest and penalties related to uncertain tax positions in income tax expense. Net Loss Per Share Attributable to Common Shareholders Basic and diluted earnings (loss) per share is calculated using the two-class method. Basic earnings (loss) per share which is based on an earnings allocation formula that determines earnings (loss) per share for the holders of the Company’s common shares and holders of the Series B preferred stock. The Series B preferred stock shares contain participation rights in undistributed earnings, but do not share in the losses of the Company. The accumulated but undeclared dividends on the Series B preferred stock of $7.6 million and $6.7 million for the years ended December 31, 2016 and 2015 , respectively, are treated as a reduction of earnings attributable to common shareholders. There were no undeclared dividends for the year ended December 31, 2017 . Diluted earnings (loss) per share includes convertible securities or common equivalent share (stock options and warrants) in addition to the Company's common shares. Common equivalent shares and treasury stock are not included in the diluted per share calculation where the effect of their inclusion would be anti-dilutive. Financial Instruments The Company’s financial instruments include receivables for which the current carrying amounts approximate market value based upon their short-term nature. Warrants Warrants that could be cash settled or have anti-dilution price protection provisions are recorded as liabilities at their estimated fair value at the date of issuance, with subsequent changes in estimated fair value recorded in other income (expense) in our statement of operations in each subsequent period. Warrants that meet the requirements for equity classification are recorded at fair value with no subsequent remeasurement. In general, warrants are measured using the Black-Scholes valuation model. The methodology is based, in part, upon inputs for which there is little or no observable market data, requiring the Company to develop its own assumptions. The assumptions used in calculating the estimated fair value of the warrants represent our best estimates; however, these estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and different assumptions are used, the change in estimated fair value of the warrant liability for those warrants that could be cash settled or have anti-dilution price protection provisions, could be materially different. |