Accounting Policies | B. Accounting Policies Principles of Consolidation The consolidated financial statements include our accounts and results of operations and those of our wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Revenue Recognition Our license and collaboration agreements may contain multiple elements, including license and technology access fees, research and development funding, manufacturing revenue, cost-sharing, milestones and royalties. The deliverables under such an arrangement are evaluated under Accounting Standards Codification (“ASC”) 605-25, Multiple-Element Arrangements. Other than for our collaboration with Healios that has remaining deliverables, we have recognized the full amount of license fees under our collaboration agreements as contract revenue under ASC 605-25 605-S25, non-substantive We recognize revenue, in full, in the period that the milestone is achieved from at-risk, Grant revenue consists of funding under cost reimbursement programs primarily from federal and non-profit We recognize contract revenue from royalties relating to the sale by a licensee of the licensed product. Royalty revenue is recognized on an accrual basis in accordance with the substance of the relevant agreement and based on the reports from the licensee to enable calculation of the royalty due. We began receiving in 2014 tiered royalties from RTI on worldwide commercial sales of implants using our technologies based on a royalty rate starting in the mid-single mid-teens, Cash and Cash Equivalents We consider all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents. Cash equivalents are primarily invested in money market funds and commercial paper. The carrying amount of our cash equivalents approximates fair value due to the short maturity of the investments. Cash used in investing activities excluded $0.1 million of accrued capital expenditures in 2016. Investments in Available-for-Sale We determine the appropriate classification of investment securities, if any, at the time of purchase and re-evaluate available-for-sale Available-for-sale available-for-sale available-for-sale available-for-sale Research and Development Research and development expenditures, which consist primarily of costs associated with external clinical and preclinical study fees, investigational product manufacturing costs and process development costs for manufacturing, personnel costs, legal expenses resulting from intellectual property application and maintenance processes, and laboratory supply and reagent costs, including direct and allocated overhead expenses, are charged to expense as incurred. Collaborative Arrangements Collaborative arrangements that involve cost or future profit sharing are reviewed to determine the nature of the arrangement and the nature of the collaborative parties’ businesses. The arrangements are also reviewed to determine if one party has sole or primary responsibility for an activity, or whether the parties have shared responsibility for the activity. If responsibility for an activity is shared and there is no principal party, then the related costs of that activity are recognized by us on a net basis in the statement of operations (e.g., total cost less reimbursement from collaborator). If we are deemed to be the principal party for an activity, then the costs and revenues associated with that activity are recognized on a gross basis in the statement of operations. The accounting may be susceptible to change if the nature of a collaborator’s business changes. Currently, we have no collaborations accounted for on a net basis. Clinical Trial Costs Clinical trial costs are accrued based on work performed by outside contractors that manage and perform the trials, and that manufacture clinical product. We obtain initial estimates of total costs based on enrollment of subjects, project management estimates, manufacturing estimates and other activities. Actual costs are typically charged to us and recognized as the tasks are completed by the contractor, and if we are invoiced based on progress payments as opposed to actual costs, we develop estimates of work completed to date. Accrued clinical trial costs may be subject to revisions as clinical trials progress, and any revisions are recorded in the period in which the facts that give rise to the revisions become known. Royalties We may be required to make future royalty payments to certain parties based on product sales under license agreements. We did not pay any royalties during the three-year period ended December 31, 2017. We may also pay sublicense fees from time-to-time Long-Lived Assets Equipment is stated at acquired cost less accumulated depreciation. Laboratory and office equipment are depreciated on the straight-line basis over the estimated useful lives (three to ten years). Leasehold improvements are amortized over the shorter of the lease term or estimated useful life. Long-lived assets are evaluated for impairment when events or changes in circumstances indicate that the carrying amount of the asset or related group of assets may not be recoverable. If the expected future undiscounted cash flows are less than the carrying amount of the asset, an impairment loss is recognized at that time. Measurement of impairment may be based upon appraisal, market value of similar assets or discounted cash flows. Proceeds from Insurance In 2016, our facility sustained flood damage representing both an unusual and infrequent event. We recognized a net insurance recovery gain of $0.7 million that was reported as a separate component of our loss from operations. Proceeds from insurance settlements, except for those directly related to investing or financing activities, were recognized as cash inflows from operating activities. Since the majority of the damage from the flood was to fully-depreciated leasehold improvements, the amount of losses were less than the amount of the insurance proceeds received. Insurance proceeds are recorded to the extent of the losses and then, only if recovery is realized or probable. Any gains in excess of losses are recognized only when the contingencies regarding the recovery are resolved, and the amount is fixed or determinable. An additional $0.3 million of insurance proceeds were received in 2018. Patent Costs and Rights Costs of prosecuting and maintaining patents and patent rights are expensed as incurred. We have filed for broad intellectual property protection on our proprietary technologies and have numerous United States and international patents and patent applications related to our technologies. Warrant Liabilities We account for common stock warrants as either liabilities or as equity instruments depending on the specific terms of the warrant agreements. Generally, warrants are classified as liabilities, as opposed to equity, if the agreement includes the potential for a cash settlement or an adjustment to the exercise price, and warrant liabilities are recorded at their fair values at each balance sheet date. We classify these warrant liabilities on the consolidated balance sheet as non-current Concentration of Credit Risk Our accounts receivable are generally comprised of amounts due from collaborators and granting authorities and are subject to concentration of credit risk due to the absence of a large number of customers. At December 31, 2017, the majority of our accounts receivable are due from granting authorities and two collaborators. We do not require collateral from these customers. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Stock-Based Compensation We recognize stock-based compensation expense on the straight-line method and use a Black-Scholes option-pricing model to estimate the fair value of option awards. The expected term of options granted represent the period of time that option grants are expected to be outstanding. We use the “simplified” method to calculate the expected life of option grants given our limited history of exercise activity and determine volatility by using our historical stock volatility. The fair value of our restricted stock units are equal to the closing price of our common stock on the date of grant and is expensed over the vesting period on a straight-line basis. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons that receive equity awards. Options may be exercised for cash or by a cashless exercise that is permitted under certain conditions. In the event of a cashless exercise, we retain the number of shares equivalent to the exercise cost based on the market value at the time of exercise, and issue the net number of shares to the holder. We recognize income tax benefits and deficiencies as income tax expense or benefit in the income statement and the tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. We also recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. Excess tax benefits are classified along with other income tax cash flows as an operating activity. In regards to forfeitures, we adopted ASU 2016-09 All of the aforementioned estimates and assumptions are evaluated on a quarterly basis and may change as facts and circumstances warrant. Changes in these assumptions can materially affect the estimate of the fair value of our share-based payments and the related amount recognized in our financial statements. The following weighted-average input assumptions were used in determining the fair value of the Company’s stock options: December 31, 2017 2016 2015 Volatility 71.2% 70.3% 83.9% Risk-free interest rate 2.0% 1.5% 2.1% Expected life of option 6.2 years 6.2 years 6.1 years Expected dividend yield 0.0% 0.0% 0.0% Income Taxes Deferred tax liabilities and assets are determined based on the differences between the financial reporting and tax basis of assets and liabilities and are measured using the tax rate and laws currently in effect. We evaluate our deferred income taxes to determine if a valuation allowance should be established against the deferred tax assets or if the valuation allowance should be reduced based on consideration of all available evidence, both positive and negative, using a “more likely than not” standard. We had no liability for uncertain income tax positions as of December 31, 2017 and 2016. Our policy is to recognize potential accrued interest and penalties related to the liability for uncertain tax benefits, if applicable, in income tax expense. Net operating loss and credit carryforwards since inception remain open to examination by taxing authorities, and will for a period post utilization. Refer to Note H regarding recent tax reform. Net Loss per Share Basic and diluted net loss per share have been computed using the weighted-average number of shares of common stock outstanding during the period. For each reporting period in which we have outstanding warrant liabilities, we evaluate the income from such warrant liabilities and consider whether it results in a potentially dilutive effect to net loss per share. For the year ended December 31, 2015, we had such a dilutive effect related to our warrants with an exercise price of $1.01, which are included in the table below. Any such warrants are then omitted from the subsequent following table of instruments that were excluded from the calculation of diluted net loss per share. The table below reconciles the net loss and the number of shares used to calculate basic and diluted net loss per share for the years ended December 31, 2017, 2016 and 2015, in thousands, except per share data. Year ended December 31, 2017 2016 2015 Numerator: Net loss and comprehensive loss $ (32,241 ) $ (15,337 ) $ (16,422 ) Less: income from change in fair value of warrants — — (332 ) Net loss attributable to common stockholders used to calculate diluted net loss per share $ (32,241 ) $ (15,337 ) $ (16,754 ) Denominator: Weighted-average shares outstanding - Basic 112,053 84,715 82,144 Potentially dilutive common shares outstanding: Warrants — — 707 Weighted-average shares used to calculate diluted net loss per share 112,053 84,715 82,851 Basic – net loss per share $ (0.29 ) $ (0.18 ) $ (0.20 ) Dilutive – net loss per share $ (0.29 ) $ (0.18 ) $ (0.20 ) We have outstanding options, restricted stock units and previously outstanding warrants that were not used in the calculation of diluted net loss per share because to do so would be antidilutive. The following instruments were excluded from the calculation of diluted net loss per share because their effects would be antidilutive: Year ended December 31, 2017 2016 2015 Stock options 8,919,113 9,236,228 7,052,642 Restricted stock units 1,648,986 1,201,159 1,069,100 Warrants — 1,893,527 2,810,000 10,568,099 12,330,914 10,931,742 Recently Issued Accounting Standards In March 2016, the FASB (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09, Compensation - Stock Compensation - Improvements to Employee Share-Based Payment Accounting In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) right-of-use In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) 2014-09 We will adopt this guidance in the first quarter of 2018, utilizing the modified retrospective transition method only with respect to contracts that were not complete as of January 1, 2018. We evaluated all of our collaborative agreements on a contract-by-contract We expect that license-related amounts, including upfront payments, exclusivity fees, additional disease indication fees, and development, regulatory and sales-based milestones will be recognized, generally, at a point in time when earned. Similarly, product supply revenue is expected to be recognized at a point in time while any service revenue will be recognized over time when earned. Topic 606 does not contain guidance specific to milestone payments but rather, requires potential milestone payments to be considered in accordance with the overall model of Topic 606. As a result, revenues from contingent milestone payments may be recognized earlier under Topic 606 than under Topic 605, based on an assessment of the probability of achievement of the milestone and the likelihood of a significant reversal of such milestone revenue at each reporting date. This assessment may result in recognizing milestone revenue before the milestone event has been achieved. In addition, Topic 606 changes guidance regarding the accounting for variable consideration received from license arrangements, which may impact the estimation of, and determination of the timing of, our related revenue recognition. As of December 31, 2017, we have substantially completed our planning to apply the necessary changes to accounting processes, procedures, systems and internal controls, and we plan to finalize our transition adjustment under Topic 606 in the first quarter of 2018. |