Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 04, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ARDM | |
Entity Registrant Name | ARADIGM CORP | |
Entity Central Index Key | 1,013,238 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 14,993,978 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 17,214 | $ 22,591 |
Restricted cash | 1,006 | 1,006 |
Receivables | 319 | 167 |
Prepaid and other current assets | 1,141 | 1,037 |
Total current assets | 19,680 | 24,801 |
Property and equipment, net | 225 | 253 |
Total assets | 19,905 | 25,054 |
Current liabilities: | ||
Accounts payable | 532 | 711 |
Accrued clinical and cost of other studies | 2,074 | 3,306 |
Accrued compensation | 812 | 1,335 |
Deferred revenue - related party current | 8,644 | |
Deferred revenue - other | 139 | |
Other accrued liabilities | 1,072 | 496 |
Total current liabilities | 13,273 | 5,848 |
Deferred revenue - related party, non-current | 718 | 5,000 |
Convertible debt, net of discount | 2,254 | 2,212 |
Convertible debt - related party, net of discount | 11,389 | 11,007 |
Total liabilities | 27,634 | 24,067 |
Commitments and contingencies | ||
Shareholders' equity (deficit): | ||
Preferred stock, 5,000,000 shares authorized, none outstanding | ||
Common stock, no par value; authorized shares: 35,045,765 at March 31, 2017 and December 31, 2016; issued and outstanding shares: 14,951,089 at March 31, 2017 and December 31, 2016 | 440,414 | 439,406 |
Accumulated deficit | (448,143) | (438,419) |
Total shareholders' equity (deficit) | (7,729) | 987 |
Total liabilities and shareholders' equity (deficit) | $ 19,905 | $ 25,054 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | ||
Common stock, shares authorized | 35,045,765 | 35,045,765 |
Common stock, shares issued | 14,951,089 | 14,951,089 |
Common stock, shares outstanding | 14,951,089 | 14,951,089 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Revenue: | ||
Contract revenue-related party | $ 1,623 | |
Contract revenue | 39 | |
Grant revenue | 31 | $ 6 |
Total revenue | 1,693 | 6 |
Operating expenses: | ||
Research and development | 2,774 | 6,451 |
General and administrative | 1,678 | 1,644 |
Restructuring and asset impairment | 1 | |
Total operating expenses | 4,452 | 8,096 |
Loss from operations | (2,759) | (8,090) |
Interest income | 28 | 10 |
Interest expense | (953) | |
Other income (expense), net | 6 | (6) |
Net loss and comprehensive loss | $ (3,678) | $ (8,086) |
Basic and diluted net loss per common share | $ (0.25) | $ (0.55) |
Shares used in computing basic and diluted net loss per common share | 14,800 | 14,761 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (3,678) | $ (8,086) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 28 | 29 |
Stock-based compensation expense | 543 | 400 |
Amortization of convertible debt discount | 424 | |
Changes in operating assets and liabilities: | ||
Receivables | (152) | (217) |
Prepaid and other current assets | (104) | (35) |
Accounts payable | (179) | 744 |
Accrued compensation | (79) | (469) |
Deferred rent | (19) | |
Deferred revenue-related party | (1,524) | |
Accrued liabilities | (656) | (1,249) |
Facility lease exit obligation | (49) | |
Net cash used in operating activities | (5,377) | (8,951) |
Cash flows from investing activities: | ||
Capital expenditures | (40) | |
Net cash used in investing activities | (40) | |
Cash flows from financing activities: | ||
Payments of convertible notes and warrants issuance costs | (50) | |
Net cash used in financing activities | (50) | |
Net decrease in cash and cash equivalents | (5,377) | (9,041) |
Cash and cash equivalents at beginning of period | 22,591 | 31,462 |
Cash and cash equivalents at end of period | 17,214 | 22,421 |
Supplemental disclosure of cash flow information: | ||
Stock issued in payment of officer bonus | 444 | |
Deferred issuance costs for planned convertible notes and warrants in accrued expenses | $ (83) | |
Cumulative effect of adoption of new accounting standards | $ 6,046 |
Organization, Basis of Presenta
Organization, Basis of Presentation, Liquidity and Going Concern | 3 Months Ended |
Mar. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Basis of Presentation, Liquidity and Going Concern | 1. Organization, Basis of Presentation, Liquidity and Going Concern Organization Aradigm Corporation (the “Company,” “we,” “our,” or “us”) is a California corporation, incorporated in 1991, focused on the development and commercialization of drugs delivered by inhalation for the treatment and prevention of severe respiratory diseases. The Company’s principal activities to date have included conducting research and development and developing collaborations. Management does not anticipate receiving revenues from the sale of any of its products during the 2017 fiscal year. The Company operates as a single operating segment. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles or GAAP for interim financial information and with the instructions to Form 10-Q S-X. 10-K 10-K”). The consolidated balance sheet at December 31, 2016 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by GAAP for complete financial statements. For further information, please refer to the consolidated financial statements and notes thereto included in the 2016 Annual Report on Form 10-K. Effective January 1, 2017, the Company elected to early adopt the requirements of Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606) The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All inter-company accounts and transactions have been eliminated in consolidation. Liquidity and Going Concern The Company has incurred significant operating losses and negative cash flows from operations. At March 31, 2017, the Company had an accumulated deficit of $448.1 million, working capital of $6.4 million and shareholders’ deficit of $7.7 million. The Company believes that its cash and cash equivalents of approximately $17.2 million as of March 31, 2017 will be sufficient to fund its operations at least through 2017, provided the Company is able to earn the $5 million milestone payment from Grifols upon the first regulatory filing for Linhaliq ™ As reflected in the accompanying interim consolidated financial statements, the Company has an accumulated deficit of $448.1 million as of March 31, 2017 that includes a net loss of $3.7 million for the quarter ended March 31, 2017, which raises doubt about the Company’s ability to continue as a going concern. The Company’s current assets of $19.7 million exceed current liabilities of $13.3 million by $6.4 million. As stated above, the Company believes that its cash and cash equivalents of approximately $17.2 million as of March 31, 2017 are sufficient to fund its operations through 2017, provided the Company is able to earn the $5 million milestone payment from Grifols upon the first regulatory filing; however, since cash and cash equivalents are insufficient to fund the Company’s operations for the ensuing twelve months from the filing of this report, there is substantial doubt about the Company’s ability to continue to operate as a going concern. While recoverability of the recorded asset amounts shown in the accompanying condensed consolidated balance sheet is dependent upon continued operations of the Company, the condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. Since cash and cash equivalents are insufficient to fund the Company’s operations for the ensuing twelve months from the filing of this report, there is substantial doubt about the Company’s ability to continue to operate as a going concern. While recoverability of the recorded asset amounts shown in the accompanying condensed consolidated balance sheet is dependent upon continued operations of the Company, the condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements, in conformity with GAAP, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. Cash and Cash Equivalents All highly liquid investments with maturities of three months or less at the time of purchase are classified as cash equivalents. Restricted Cash The Company classifies transfers to the restricted cash balance in the statement of cash flows based on the nature of the restriction. At March 31, 2017, the Company has approximately $1.0 million in restricted cash held in an interest bearing escrow account for the purpose of making a future interest payment on the Convertible Notes in May 2017. Property and Equipment The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment includes external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software includes capitalized computer software. All of the Company’s capitalized software is purchased; the Company has no internally-developed computer software. Leasehold improvements are amortized over the shorter of the term of the lease or useful life of the improvement. Convertible Instruments The Company accounts for hybrid contracts that feature conversion options in accordance with generally accepted accounting principles in the United States. ASC 815, Derivatives and Hedging Activities, or ASC 815, requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured The Company accounts for convertible instruments (when it has determined that the embedded conversion options should be bifurcated from their host instruments) in accordance with ASC 815. Under ASC 815, a portion of the proceeds received upon the issuance of the hybrid contract is allocated to the fair value of the derivative. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. Warrants Issued in Connection with Financings The Company generally accounts for warrants issued in connection with financings as a component of equity, unless there is a possibility that the Company may have to settle the warrants in cash. For warrants issued with the deemed possibility of a cash settlement, the Company records the fair value of the issued warrants as a liability at each reporting date and records changes in the estimated fair value as a non-cash Accounting for Costs Associated with Exit or Disposal Activities The Company recognizes a liability for the cost associated with an exit or disposal activity that is measured initially at its fair value in the period in which the liability is incurred. Costs to terminate an operating lease or other contracts are (a) costs to terminate the contract before the end of its term or (b) costs that will continue to be incurred under the contract for its remaining term without economic benefit to the entity. In periods subsequent to initial measurement, changes to the liability are measured using the credit-adjusted risk-free rate that was used to measure the liability initially. Revenue Recognition Beginning January 1, 2017, the Company follows the provisions of ASC Topic 606, Revenue from Contracts with Customers. The guidance provides a unified model to determine how revenue is recognized. The Company’s contract revenues consist of revenues from grants, collaboration agreements and feasibility studies. License and collaboration revenue is primarily generated through agreements with strategic partners for the development and commercialization of our product candidates. The terms of the agreement typically include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones and royalties on net product sales. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in ASC Topic 606. A contract’s transaction price is allocated to each distinct performance obligation based on relative estimated selling prices and recognized as revenue when, or as, the performance obligation is satisfied. The Company’s performance obligations include license rights, development services, and services associated with regulatory submission and approval processes. The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. The Company’s performance obligations for services are satisfied over time, based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. The Company recognizes revenue for license rights of functional intellectual property at the point in time the customer has the ability to use and benefit from the license. Significant management judgment may be required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. The Company recognizes revenue for license rights at the point in time the customer has the ability to use and benefit from the license rights. The Company allocates the total transaction price to each performance obligation in an amount based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation. Estimated selling prices for license rights are calculated using a discounted cash flow analysis of the commercial potential of the products in the territories over the estimated patent life. This discounted cash flow model requires subjective input including projected sales and related expenses, and company-specific discount rate based on management’s best estimates. To estimate selling prices for development services and regulatory submission services, the Company uses a cost plus reasonable margin approach. The Company has both fixed and variable consideration in its contracts. Reimbursements of development costs are considered fixed, while milestone payments are identified as variable consideration and included in expected consideration when they are considered probable. Research and Development Research and development expenses consist of costs incurred for company-sponsored, collaborative and contracted research and development activities. These costs include direct and research-related overhead expenses. Research and development expenses that are reimbursed under collaborative and government grants approximate the revenue recognized under such agreements. The Company expenses research and development costs as such costs are incurred. The Company is eligible under the AusIndustry research and development tax incentive program to obtain a cash amount from the Australian Taxation Office. The tax incentive is available to the Company on the basis of specific criteria with which the Company must comply. Specifically, the Company must have revenue of less than AUD $20.0 million and cannot be controlled by income tax exempt entities. These research and development tax incentives are recognized as contra research and development expense when the right to receive has been attained and funds are considered to be collectible. The tax incentive is denominated in Australian dollars and, therefore, the related receivable is remeasured into U.S. dollars as of each reporting date. The Company recognizes the funds related to its Australian research and development tax incentives that are not subject to refund provisions as a reduction of research and development expense. The amounts are determined on a cost reimbursement basis and the incentive is related to the Company’s research and development expenditures and is refundable regardless of whether any Australian tax is owed. These Australian research and development tax incentives are recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. During the three months ended March 31, 2017, the Company offset its research and development costs by $0.9 million through the recognition of tax incentive credits. Stock-Based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation-Stock Compensation 505-50, Equity-Equity Based Payments to Non-Employees Income Taxes The Company makes certain estimates and judgments in determining income tax expense for consolidated financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. As part of the process of preparing the financial statements, the Company is required to estimate income taxes in each of the jurisdictions in which it operates. This process involves the Company estimating its current tax exposure under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities which are included in the Company’s consolidated balance sheets. The Company assesses the likelihood that it will be able to recover its deferred tax assets. The Company considers all available evidence, both positive and negative, including the historical levels of income and losses, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If the Company does not consider it more likely than not that it will recover its deferred tax assets, the Company records a valuation allowance against the deferred tax assets that it estimates will not ultimately be recoverable. At March 31, 2017, and December 31, 2016 the Company believed that the amount of its deferred income taxes would not be ultimately recovered. Accordingly, the Company recorded a full valuation allowance for deferred tax assets. However, should there be a change in the Company’s ability to recover its deferred tax assets the Company would recognize a benefit to its tax provision in the period in which it determines that it is more likely than not that it will recover its deferred tax assets. Net Income/(Loss) Per Common Share Basic net income/(loss) per common share is computed using the weighted-average number of shares of common stock outstanding during the period less the weighted-average number of restricted shares of common stock subject to repurchase. Potentially dilutive securities were not included in the net loss per common share calculation for the three months ended March 31, 2017, and 2016 because the inclusion of such shares would have had an anti-dilutive effect. Accounting Changes In March 2016, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update, or ASU 2016-09, Improvements to Employee Share-Based Payment Accounting In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers Effective January 1, 2017, the Company elected to early adopt the requirements of Topic 606 using the modified retrospective method, applying the new guidance to the most current period presented with the cumulative effect of changes reflected in the opening balance of accumulated deficit. The adoption of the new revenue recognition guidance resulted in increases of $6.0 million to deferred revenue and the accumulated deficit as of January 1, 2017. For the three months ended March 31, 2017, revenue increased by $1.5 million for services performed in the period which under the prior milestone recognition methodology would not be recognized until the milestone was achieved, research and development expenses decreased by $0.2 million, net loss decreased by $1.7 million, and basic and diluted net loss per share decreased by $0.10 per share. Recently Issued Accounting Pronouncements As compared to the recent accounting pronouncements described in the Company’s 2016 Annual Report on Form 10-K, |
Cash and Cash Equivalents
Cash and Cash Equivalents | 3 Months Ended |
Mar. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | 3. Cash and Cash Equivalents At March 31, 2017 and December 31, 2016, the Company’s cash and cash equivalents approximated their fair values. The Company currently invests its cash and cash equivalents in money market funds. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The Company follows ASC 820, Fair Value Measurements The Company’s cash and cash equivalents at March 31, 2017 consist of cash and money market funds. Money market funds are valued using quoted market prices. |
Other Accrued Liabilities
Other Accrued Liabilities | 3 Months Ended |
Mar. 31, 2017 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | 5. Other Accrued Liabilities At March 31, 2017, other accrued liabilities consisted of accrued expenses for interest of $863,000, expenses for services of $106,000 and payroll withholding liabilities of $103,000. The liability for accrued interest of $863,000 is related to the Convertible Notes as outlined in Note 6 and represents the interest on the Convertible Notes that is accrued but unpaid as of March 31, 2017. At December 31, 2016, other accrued liabilities consisted of accrued expenses for interest of $340,000, expenses for services of $105,000 and payroll withholding liabilities of $51,000. |
Convertible Notes and Warrants
Convertible Notes and Warrants | 3 Months Ended |
Mar. 31, 2017 | |
Text Block [Abstract] | |
Convertible Notes and Warrants | 6. Convertible Notes and Warrants On April 21, 2016, the Company entered into a securities purchase agreement to conduct a private offering, or the Convertible Note Financing, consisting of $23 million in aggregate principal amount of 9% senior convertible notes convertible into shares of common stock, or the Convertible Notes, and 263,436 warrants to purchase shares of the Company’s common stock, or the Warrants. The Convertible Notes bear interest at a rate of 9% per year, payable semiannually in arrears on November 1 and May 1 of each year commencing on November 1, 2016. The Convertible Notes mature on May 1, 2021, unless earlier redeemed or converted. The Convertible Notes are senior unsecured and unsubordinated obligations; rank equal in right of payment to the Company’s existing and future unsecured indebtedness that is not subordinated and are effectively subordinated in right of payment to the Company’s existing and future secured indebtedness. On or after December 1, 2017, the Company may redeem for cash all or a portion of the Convertible Notes if the last reported sale price of the Company’s common stock is at any time equal to or greater than 200% of the conversion price then in effect for at least twenty trading days immediately preceding the date on which the Company provides notice of redemption, at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The Indenture provides for customary events of default which may result in the acceleration of the maturity of the Notes, including, but not limited to, cross acceleration to certain other indebtedness of the Company and its subsidiaries. In the case of an event of default arising from specified events of bankruptcy or insolvency or reorganization all outstanding Convertible Notes will become due and payable immediately without further action or notice. If any other event of default under the Indenture occurs or is continuing, the trustee or holders of at least 25% in aggregate principal amount of the then outstanding Convertible Notes may declare all of the Convertible Notes to be due and payable immediately. The Warrants have a five-year term and are exercisable at $5.21 per share of common stock. The exercise price is subject to adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events or upon any distributions of assets, including cash, stock or other property to the Company’s shareholders. On April 25, 2016, the initial closing of the Convertible Notes took place under which the Company raised $20 million from a total of two investors and issued 4,319 Warrants to one investor. Of the $20 million, $19.9 million was financed by Grifols, a related party to the Company, as described in Note 8 below. The fair value of the warrants issued in the second closing was $11,000 and was recorded as a component of equity and discount to the debt host. There were 3,319,820 common shares underlying the conversion feature that was bifurcated as a derivative liability due to the Conversion Share Cap. The effective interest rate of the liability component was equal to 22.9% for the three months ended March 31, 2017. On July 14, 2016, the second and final closing of the Convertible Notes took place under which the Company raised $3 million from a total of two investors and issued 259,117 Warrants. The fair value of the warrants issued in the second closing was $662,000 and was recorded as a component of equity and discount to the debt host. The effective interest rate of the liability component was equal to 16.24% for the three months ended March 31, 2017. The financing costs of $2.4 million incurred in connection with the issuance of the Convertible Notes were allocated to the derivative liability, warrants and Convertible Note components based on their relative fair values. Financing costs of $1.4 million allocated to the Convertible Note host are being amortized using the effective interest rate method and recognized as non-cash As of March 31, 2017, the Convertible Notes consisted of the following: March 31, 2017 (in thousands, except Principal value $ 23,000 Unamortized debt discount (8,133 ) Unamortized debt issuance costs (1,224 ) Carrying value of the convertible notes $ 13,643 Conversion rate (shares of common stock per $1,000 principal amount of notes) 191.9386 Conversion price (per share of common stock) $ 5.21 For the three months ended March 31, 2017, the Company recognized interest expense associated with its Convertible Notes as follows: Three Months ended March 31, 2017 (in thousands) Cash Interest Expense Coupon interest expense $ 529 Noncash Interest Expense Amortization of debt discount 368 Amortization of transaction costs 56 $ 953 As of March 31, 2017, the unamortized debt discount will be amortized over a remaining period of approximately 4.09 years. The if converted value as of March 31, 2017 does not exceed the principal balance of the Convertible Notes. Accrued interest payable at March 31, 2017 is $863,000 and is included in other accrued liabilities. For more information on the Company’s accounting for Convertible Notes and Warrants, see Note 7 to the consolidated financial statements included in our 2016 Annual Report on Form 10-K. |
Collaboration Agreement
Collaboration Agreement | 3 Months Ended |
Mar. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreement | 7. Collaboration Agreement Grifols License and Collaboration Agreement See Note 8 to the audited consolidated financial statements included in Part II, Item 8 of the 2016 Annual Report on Form 10-K Upon adoption of ASU No. 2014-09, the Company deferred an additional $6.0 million for the portion of the transaction price allocated to development phase services delivered prior to January 1, 2017 which under the new guidance is allocated to unsatisfied (or partially satisfied) performance obligations as of January 1, 2017. As a result of adoption, an additional $1.5 million of contract revenue was recognized for performance obligations satisfied during the three months ended March 31, 2017. Under the License Agreement, the Company is eligible to receive up to an additional $20 million in payments upon the achievement of regulatory filing and approval milestones. The following table shows the reconciliation of Contract Assets and Contract Liabilities from what was disclosed in the Form 10-K for the year ended December 31, 2016 and the effect of the modified retrospective adoption of the revenue guidance at January 1, 2017: Contract Assets Balance at December 31, 2016 — Changes in estimated consideration — Performance obligations satisfied — Balance at January 1, 2017 — Contract Liabilities Balance at December 31, 2016 $ 5,000,000 Changes in estimated consideration — Unsatisfied performance obligations 6,025,728 Balance at January 1, 2017 $ 11,025,728 The Company’s performance obligations include those related to the worldwide license to commercialize products developed from the collaboration development services for Phase III clinical trials that were completed as of December 31, 2016, regulatory submission services for first indication, and regulatory approval services in the US and EU for first indication. Milestone payments related to regulatory submission and approval services is considered variable and excluded from the transaction price as of the date of adoption and the quarter ended March 31, 2017. The Company recognizes revenue from license rights at a point in time, which is when the customer has the ability to use and benefit from the license rights. The Company recognizes revenue from its services performance obligations over time using a cost-to-cost input method. The Company has $11.0 million related to the transaction price of the Grifols’ arrangement allocated to the performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2017. For information on the Company’s accounting policy regarding revenue recognition, refer to Note 2 above. |
Stock-Based Compensation and St
Stock-Based Compensation and Stock Options and Awards | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation and Stock Options and Awards | 8. Stock-Based Compensation and Stock Options and Awards The following table shows the stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2017 and 2016 (in thousands): March 31, March 31, 2017 2016 Costs and expenses: Research and development $ 306 $ 167 General and administrative 237 233 Total stock-based compensation expense $ 543 $ 400 There was no capitalized stock-based employee compensation cost for the three months ended March 31, 2017 and 2016. Since the Company did not record a tax provision during the quarters ended March 31, 2017 and 2016, there was no recognized tax benefit associated with stock-based compensation expense. Stock Option Plans: 2005 Equity Incentive Plan (the “2005 Plan”) and 2015 Equity Incentive Plan (the “2015 Plan”) On March 13, 2015 the Board adopted and, on May 14, 2015 the Company’s shareholders approved the 2015 Plan. The 2015 Plan replaces the Company’s 2005 Plan which expired in March 2015. The 2015 Plan is intended to promote our long-term success and increase shareholder value by attracting, motivating, and retaining non-employee Stock Option Activity The following is a summary of activity under the 2005 Plan and the 2015 Plan for the three months ended March 31, 2017: Shares Available for Balance at January 1, 2017 1,510,272 Options granted (614,946 ) Options cancelled 2,701 Balance at March 31, 2017 898,027 Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at January 1, 2017 1,923,595 $ 6.86 Options granted 614,946 $ 1.98 Options cancelled (2,701 ) $ 49.20 Outstanding at March 31, 2017 2,535,840 $ 5.65 8.51 $ — Exercisable at March 31, 2017 1,030,011 $ 6.57 8.01 $ — No stock options were exercised during the three months ended March 31, 2017. The total amount of unrecognized compensation cost related to non-vested A summary of the activity of the Company’s unvested restricted stock and performance bonus stock award activities for the quarter ending March 31, 2017 is presented below. The ending balance represents the maximum number of shares that could be earned or vested under the 2005 Plan and 2015 Plan: Restricted Stock Awards Number of Shares Weighted Grant Outstanding at January 1, 2017 152,238 $ 3.96 Restricted stock awards vested (4,688 ) 4.04 Outstanding at March 31, 2017 147,550 $ 3.96 For restricted stock awards the Company recognizes compensation expense over the vesting period for the fair value of the stock award on the measurement date. As of March 31, 2017, there was approximately $365,000 of total unrecognized compensation costs, related to non-vested |
Net Loss and Comprehensive Loss
Net Loss and Comprehensive Loss Per Common Share | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss and Comprehensive Loss Per Common Share | 9. Net Loss and Comprehensive Loss Per Common Share The Company computes basic net loss per common share using the weighted-average number of shares of common stock outstanding during the period less the weighted-average number of shares of common stock subject to repurchase. The effects of including the incremental shares associated with options, warrants and unvested restricted stock are anti-dilutive, and are not included in the diluted weighted-average number of shares of common stock outstanding for the three months ended March 31, 2017 and 2016. The Company excluded the following securities from the calculation of diluted net loss per common share for the three months ended March 31, 2017 and 2016, as their effect would be anti-dilutive (in thousands): Three months ended March 31, 2017 2016 Common shares underlying convertible notes 4,289 — Outstanding stock options 2,536 995 Common shares underlying warrants 263 71 Restricted stock 148 166 Unvested restricted stock units 10 10 |
Summary of Significant Accoun15
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements, in conformity with GAAP, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents All highly liquid investments with maturities of three months or less at the time of purchase are classified as cash equivalents. |
Restricted Cash | Restricted Cash The Company classifies transfers to the restricted cash balance in the statement of cash flows based on the nature of the restriction. At March 31, 2017, the Company has approximately $1.0 million in restricted cash held in an interest bearing escrow account for the purpose of making a future interest payment on the Convertible Notes in May 2017. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment includes external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software includes capitalized computer software. All of the Company’s capitalized software is purchased; the Company has no internally-developed computer software. Leasehold improvements are amortized over the shorter of the term of the lease or useful life of the improvement. |
Convertible Instruments | Convertible Instruments The Company accounts for hybrid contracts that feature conversion options in accordance with generally accepted accounting principles in the United States. ASC 815, Derivatives and Hedging Activities, or ASC 815, requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured The Company accounts for convertible instruments (when it has determined that the embedded conversion options should be bifurcated from their host instruments) in accordance with ASC 815. Under ASC 815, a portion of the proceeds received upon the issuance of the hybrid contract is allocated to the fair value of the derivative. The derivative is subsequently marked to market at each reporting date based on current fair value, with the changes in fair value reported in results of operations. |
Warrants Issued in Connection with Financings | Warrants Issued in Connection with Financings The Company generally accounts for warrants issued in connection with financings as a component of equity, unless there is a possibility that the Company may have to settle the warrants in cash. For warrants issued with the deemed possibility of a cash settlement, the Company records the fair value of the issued warrants as a liability at each reporting date and records changes in the estimated fair value as a non-cash |
Accounting for Costs Associated with Exit or Disposal Activities | Accounting for Costs Associated with Exit or Disposal Activities The Company recognizes a liability for the cost associated with an exit or disposal activity that is measured initially at its fair value in the period in which the liability is incurred. Costs to terminate an operating lease or other contracts are (a) costs to terminate the contract before the end of its term or (b) costs that will continue to be incurred under the contract for its remaining term without economic benefit to the entity. In periods subsequent to initial measurement, changes to the liability are measured using the credit-adjusted risk-free rate that was used to measure the liability initially. |
Revenue Recognition | Revenue Recognition Beginning January 1, 2017, the Company follows the provisions of ASC Topic 606, Revenue from Contracts with Customers. The guidance provides a unified model to determine how revenue is recognized. The Company’s contract revenues consist of revenues from grants, collaboration agreements and feasibility studies. License and collaboration revenue is primarily generated through agreements with strategic partners for the development and commercialization of our product candidates. The terms of the agreement typically include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones and royalties on net product sales. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer, and is the unit of account in ASC Topic 606. A contract’s transaction price is allocated to each distinct performance obligation based on relative estimated selling prices and recognized as revenue when, or as, the performance obligation is satisfied. The Company’s performance obligations include license rights, development services, and services associated with regulatory submission and approval processes. The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. The Company’s performance obligations for services are satisfied over time, based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. The Company recognizes revenue for license rights of functional intellectual property at the point in time the customer has the ability to use and benefit from the license. Significant management judgment may be required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. The Company recognizes revenue for license rights at the point in time the customer has the ability to use and benefit from the license rights. The Company allocates the total transaction price to each performance obligation in an amount based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation. Estimated selling prices for license rights are calculated using a discounted cash flow analysis of the commercial potential of the products in the territories over the estimated patent life. This discounted cash flow model requires subjective input including projected sales and related expenses, and company-specific discount rate based on management’s best estimates. To estimate selling prices for development services and regulatory submission services, the Company uses a cost plus reasonable margin approach. The Company has both fixed and variable consideration in its contracts. Reimbursements of development costs are considered fixed, while milestone payments are identified as variable consideration and included in expected consideration when they are considered probable. |
Research and Development | Research and Development Research and development expenses consist of costs incurred for company-sponsored, collaborative and contracted research and development activities. These costs include direct and research-related overhead expenses. Research and development expenses that are reimbursed under collaborative and government grants approximate the revenue recognized under such agreements. The Company expenses research and development costs as such costs are incurred. The Company is eligible under the AusIndustry research and development tax incentive program to obtain a cash amount from the Australian Taxation Office. The tax incentive is available to the Company on the basis of specific criteria with which the Company must comply. Specifically, the Company must have revenue of less than AUD $20.0 million and cannot be controlled by income tax exempt entities. These research and development tax incentives are recognized as contra research and development expense when the right to receive has been attained and funds are considered to be collectible. The tax incentive is denominated in Australian dollars and, therefore, the related receivable is remeasured into U.S. dollars as of each reporting date. The Company recognizes the funds related to its Australian research and development tax incentives that are not subject to refund provisions as a reduction of research and development expense. The amounts are determined on a cost reimbursement basis and the incentive is related to the Company’s research and development expenditures and is refundable regardless of whether any Australian tax is owed. These Australian research and development tax incentives are recognized when there is reasonable assurance that the incentive will be received, the relevant expenditure has been incurred and the amount of the consideration can be reliably measured. During the three months ended March 31, 2017, the Company offset its research and development costs by $0.9 million through the recognition of tax incentive credits. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation-Stock Compensation 505-50, Equity-Equity Based Payments to Non-Employees |
Income Taxes | Income Taxes The Company makes certain estimates and judgments in determining income tax expense for consolidated financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. As part of the process of preparing the financial statements, the Company is required to estimate income taxes in each of the jurisdictions in which it operates. This process involves the Company estimating its current tax exposure under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities which are included in the Company’s consolidated balance sheets. The Company assesses the likelihood that it will be able to recover its deferred tax assets. The Company considers all available evidence, both positive and negative, including the historical levels of income and losses, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If the Company does not consider it more likely than not that it will recover its deferred tax assets, the Company records a valuation allowance against the deferred tax assets that it estimates will not ultimately be recoverable. At March 31, 2017, and December 31, 2016 the Company believed that the amount of its deferred income taxes would not be ultimately recovered. Accordingly, the Company recorded a full valuation allowance for deferred tax assets. However, should there be a change in the Company’s ability to recover its deferred tax assets the Company would recognize a benefit to its tax provision in the period in which it determines that it is more likely than not that it will recover its deferred tax assets. |
Net Income/(Loss) Per Common Share | Net Income/(Loss) Per Common Share Basic net income/(loss) per common share is computed using the weighted-average number of shares of common stock outstanding during the period less the weighted-average number of restricted shares of common stock subject to repurchase. Potentially dilutive securities were not included in the net loss per common share calculation for the three months ended March 31, 2017, and 2016 because the inclusion of such shares would have had an anti-dilutive effect. |
Accounting Changes | Accounting Changes In March 2016, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update, or ASU 2016-09, Improvements to Employee Share-Based Payment Accounting In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers Effective January 1, 2017, the Company elected to early adopt the requirements of Topic 606 using the modified retrospective method, applying the new guidance to the most current period presented with the cumulative effect of changes reflected in the opening balance of accumulated deficit. The adoption of the new revenue recognition guidance resulted in increases of $6.0 million to deferred revenue and the accumulated deficit as of January 1, 2017. For the three months ended March 31, 2017, revenue increased by $1.5 million for services performed in the period which under the prior milestone recognition methodology would not be recognized until the milestone was achieved, research and development expenses decreased by $0.2 million, net loss decreased by $1.7 million, and basic and diluted net loss per share decreased by $0.10 per share. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements As compared to the recent accounting pronouncements described in the Company’s 2016 Annual Report on Form 10-K, |
Convertible Notes and Warrants
Convertible Notes and Warrants (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Text Block [Abstract] | |
Summary of Convertible Notes | As of March 31, 2017, the Convertible Notes consisted of the following: March 31, 2017 (in thousands, except Principal value $ 23,000 Unamortized debt discount (8,133 ) Unamortized debt issuance costs (1,224 ) Carrying value of the convertible notes $ 13,643 Conversion rate (shares of common stock per $1,000 principal amount of notes) 191.9386 Conversion price (per share of common stock) $ 5.21 |
Summary of Interest Expense Associated with Convertible Notes | For the three months ended March 31, 2017, the Company recognized interest expense associated with its Convertible Notes as follows: Three Months ended March 31, 2017 (in thousands) Cash Interest Expense Coupon interest expense $ 529 Noncash Interest Expense Amortization of debt discount 368 Amortization of transaction costs 56 $ 953 |
Collaboration Agreement (Tables
Collaboration Agreement (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Reconciliation of Contract Assets and Contract Liabilities | The following table shows the reconciliation of Contract Assets and Contract Liabilities from what was disclosed in the Form 10-K for the year ended December 31, 2016 and the effect of the modified retrospective adoption of the revenue guidance at January 1, 2017: Contract Assets Balance at December 31, 2016 — Changes in estimated consideration — Performance obligations satisfied — Balance at January 1, 2017 — Contract Liabilities Balance at December 31, 2016 $ 5,000,000 Changes in estimated consideration — Unsatisfied performance obligations 6,025,728 Balance at January 1, 2017 $ 11,025,728 |
Stock-Based Compensation and 18
Stock-Based Compensation and Stock Options and Awards (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock-Based Compensation Expense | The following table shows the stock-based compensation expense included in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2017 and 2016 (in thousands): March 31, March 31, 2017 2016 Costs and expenses: Research and development $ 306 $ 167 General and administrative 237 233 Total stock-based compensation expense $ 543 $ 400 |
Schedule of Activity Under Stock Option Plan | The following is a summary of activity under the 2005 Plan and the 2015 Plan for the three months ended March 31, 2017: Shares Available for Balance at January 1, 2017 1,510,272 Options granted (614,946 ) Options cancelled 2,701 Balance at March 31, 2017 898,027 Options Outstanding Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at January 1, 2017 1,923,595 $ 6.86 Options granted 614,946 $ 1.98 Options cancelled (2,701 ) $ 49.20 Outstanding at March 31, 2017 2,535,840 $ 5.65 8.51 $ — Exercisable at March 31, 2017 1,030,011 $ 6.57 8.01 $ — |
Schedule of Unvested Restricted Stock Award Activities | A summary of the activity of the Company’s unvested restricted stock and performance bonus stock award activities for the quarter ending March 31, 2017 is presented below. The ending balance represents the maximum number of shares that could be earned or vested under the 2005 Plan and 2015 Plan: Restricted Stock Awards Number of Shares Weighted Grant Outstanding at January 1, 2017 152,238 $ 3.96 Restricted stock awards vested (4,688 ) 4.04 Outstanding at March 31, 2017 147,550 $ 3.96 |
Net Loss and Comprehensive Lo19
Net Loss and Comprehensive Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Securities Excluded from Calculation of Diluted Net Loss per Common Share | The Company excluded the following securities from the calculation of diluted net loss per common share for the three months ended March 31, 2017 and 2016, as their effect would be anti-dilutive (in thousands): Three months ended March 31, 2017 2016 Common shares underlying convertible notes 4,289 — Outstanding stock options 2,536 995 Common shares underlying warrants 263 71 Restricted stock 148 166 Unvested restricted stock units 10 10 |
Organization, Basis of Presen20
Organization, Basis of Presentation, Liquidity and Going Concern - Additional Information (Detail) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2017USD ($)Segment | Mar. 31, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Summary Of Organization And Operations [Line Items] | ||||
Number of operating segment | Segment | 1 | |||
Accumulated deficit | $ (448,143) | $ (438,419) | ||
Working capital | 6,400 | |||
Shareholders' deficit | (7,729) | 987 | ||
Cash and cash equivalents | 17,214 | $ 22,421 | 22,591 | $ 31,462 |
Net loss | (3,678) | $ (8,086) | ||
Current assets | 19,680 | 24,801 | ||
Current liabilities | 13,273 | $ 5,848 | ||
Current assets excess over current liabilities | $ 6,400 | |||
Existence of substantial doubt about going concern, within one year | false | |||
Grifols [Member] | ||||
Summary Of Organization And Operations [Line Items] | ||||
Milestone payment to be earned | $ 5,000 |
Summary of Significant Accoun21
Summary of Significant Accounting Policies - Additional Information (Detail) | Jan. 01, 2017USD ($) | Mar. 31, 2017USD ($)$ / shares | Mar. 31, 2017AUD | Dec. 31, 2016USD ($) |
Income Tax Expense Benefit [Line Items] | ||||
Restricted cash held in interest bearing escrow account | $ 1,006,000 | $ 1,006,000 | ||
Amount of research and development cost offset through the recognition of tax incentive credits | 900,000 | |||
Accounting Standards Update 2014-09 [Member] | ||||
Income Tax Expense Benefit [Line Items] | ||||
Increase in deferred revenue and accumulated deficit | $ 6,000,000 | |||
Increase in revenue for services performed | 1,500,000 | |||
Decrease in research and development expenses | 200,000 | |||
Decrease in net loss | $ 1,700,000 | |||
Decrease in basic and diluted net loss per share | $ / shares | $ 0.10 | |||
Accounting Standards Update 2016-09 [Member] | ||||
Income Tax Expense Benefit [Line Items] | ||||
Cumulative effect on retained earning net of tax due to accounting changes | $ 22,000 | |||
Australian Taxation Office [Member] | ||||
Income Tax Expense Benefit [Line Items] | ||||
Maximum amount of revenue subject to eligible tax incentive under AusIndustry research and development program | AUD | AUD 20,000,000 |
Other Accrued Liabilities - Add
Other Accrued Liabilities - Additional Information (Detail) - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for interest | $ 863,000 | |
Accrued payroll withholding liabilities | 812,000 | $ 1,335,000 |
Other Accrued Liabilities [Member] | ||
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for services | 106,000 | 105,000 |
Accrued payroll withholding liabilities | 103,000 | 51,000 |
Convertible Debt [Member] | Other Accrued Liabilities [Member] | ||
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for interest | $ 863,000 | $ 340,000 |
Convertible Notes and Warrant23
Convertible Notes and Warrants - Additional Information (Detail) | Dec. 01, 2017$ / shares | Jul. 14, 2016USD ($)Investorshares | Apr. 25, 2016USD ($)Investorshares | Apr. 21, 2016USD ($)shares | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Debt Instrument [Line Items] | ||||||
Aggregate principal amount | $ 23,000,000 | |||||
Amortization of financing cost | 56,000 | |||||
Accrued interest payable | $ 863,000 | |||||
Second and Final Closing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Fair value of the warrants issued | $ 662,000 | $ 11,000 | ||||
Class of warrants or rights, issued | shares | 259,117 | |||||
Effective interest rate on liability component | 16.24% | |||||
Class of Warrant Issued April 22, 2016 [Member] | Initial Closing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Amount funded by number of investors | Investor | 2 | |||||
Class of warrants or rights, issued | shares | 4,319 | |||||
Class of Warrant Issued April 22, 2016 [Member] | Second and Final Closing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Amount funded by number of investors | Investor | 2 | |||||
Convertible Debt [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Financing cost | $ 2,400,000 | |||||
Amortization of financing cost | $ 1,400,000 | |||||
Financing costs, derivative liability and warrant | $ 997,000 | |||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Unamortized debt discount remaining amortization period | 4 years 1 month 2 days | |||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | Initial Closing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of convertible debt | $ 20,000,000 | |||||
Number of common shares convertible to derivative liability due to Conversion Share Cap | shares | 3,319,820 | |||||
Effective interest rate on liability component | 22.90% | |||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | Second and Final Closing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of convertible debt | $ 3,000,000 | |||||
Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | Grifols [Member] | Initial Closing [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from related party convertible debt | $ 19,900,000 | |||||
Private Placement [Member] | Class of Warrant Issued April 22, 2016 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Number of shares into which the class of warrant may be converted | shares | 263,436 | |||||
Private Placement [Member] | Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Aggregate principal amount | $ 23,000,000 | |||||
Maturity date | May 1, 2021 | |||||
Notes bear interest rate | 9.00% | |||||
Frequency of periodic payment of interest | Payable semiannually in arrears on November 1 and May 1 of each year commencing on November 1, 2016. | |||||
Scenario, Forecast [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Number of trading days for effectiveness preceding issuance of redemption notice | 20 days | |||||
Redeemable portion of notes equal to percentage of principal amount of notes | 100.00% | |||||
Scenario, Forecast [Member] | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Redeemable portion of notes equal to or greater than percentage of sale price of common stock | 200.00% | |||||
Scenario, Forecast [Member] | Class of Warrant Issued April 22, 2016 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Warrants term | 5 years | |||||
Warrants, exercise price | $ / shares | $ 5.21 | |||||
Scenario, Forecast [Member] | Senior Convertible Notes Due 2021 [Member] | Convertible Debt [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Percentage of principal amount of outstanding debt held by trustee or holders, in which they may declare debt to be due and payable immediately in event of default | 25.00% |
Convertible Notes and Warrant24
Convertible Notes and Warrants - Summary of Convertible Notes (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2017USD ($)$ / sharesshares | |
Convertible Debt [Abstract] | |
Principal value | $ 23,000 |
Unamortized debt discount | (8,133) |
Unamortized debt issuance costs | (1,224) |
Carrying value of the convertible notes | $ 13,643 |
Conversion rate (shares of common stock per $1,000 principal amount of notes) | shares | 191.9386 |
Conversion price (per share of common stock) | $ / shares | $ 5.21 |
Convertible Notes and Warrant25
Convertible Notes and Warrants - Summary of Convertible Notes (Parenthetical) (Detail) | 3 Months Ended |
Mar. 31, 2017USD ($) | |
Convertible Debt [Abstract] | |
Debt conversion, initial conversion ratio, denominator | $ 1,000 |
Convertible Notes and Warrant26
Convertible Notes and Warrants - Summary of Interest Expense Associated with Convertible Notes (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2017USD ($) | |
Interest Expense [Abstract] | |
Coupon interest expense | $ 529 |
Noncash Interest Expense | |
Amortization of debt discount | 368 |
Amortization of transaction costs | 56 |
Interest expense | $ 953 |
Collaboration Agreement - Grifo
Collaboration Agreement - Grifols License and Collaboration Agreement - Additional Information (Detail) - USD ($) | Jan. 01, 2017 | Mar. 31, 2017 | Dec. 31, 2016 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Additional contract revenue recognized | $ 6,025,728 | ||
Unsatisfied performance obligations | 11,025,728 | $ 5,000,000 | |
Accounting Standards Update 2014-09 [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Additional contract revenue recognized | $ 6,000,000 | ||
Additional deferred revenue | $ 1,500,000 | ||
Grifols [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Percentage of equity held by related party | 35.00% | ||
Unsatisfied performance obligations | $ 11,000,000 | ||
Maximum [Member] | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Additional payments receivable upon the achievement of regulatory filing and approval milestones | $ 20,000,000 |
Collaboration Agreement - Sched
Collaboration Agreement - Schedule of Reconciliation of Contract Assets and Contract Liabilities (Detail) | Jan. 01, 2017USD ($) |
Deferred Revenue Disclosure [Abstract] | |
Contract assets, beginning balance | $ 0 |
Changes in estimated consideration | 0 |
Performance obligations satisfied | 0 |
Contract assets, ending balance | 0 |
Contract liabilities, beginning balance | 5,000,000 |
Changes in estimated consideration | 0 |
Unsatisfied performance obligations | 6,025,728 |
Contract liabilities, ending balance | $ 11,025,728 |
Stock-Based Compensation and 29
Stock-Based Compensation and Stock Options and Awards - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Costs and Expenses | ||
Total stock-based compensation expense | $ 543 | $ 400 |
Research and Development [Member] | ||
Costs and Expenses | ||
Total stock-based compensation expense | 306 | 167 |
General and Administrative [Member] | ||
Costs and Expenses | ||
Total stock-based compensation expense | $ 237 | $ 233 |
Stock-Based Compensation and 30
Stock-Based Compensation and Stock Options and Awards - Additional Information (Detail) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Capitalized stock-based employee compensation cost | $ 0 | $ 0 | |
Tax benefit associated with stock-based compensation expense | $ 0 | $ 0 | |
2005 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Plan expiration date | 2015-03 | ||
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average period over which unrecognized compensation costs expected to be recognized | 1 year 7 months 21 days | ||
Unrecognized compensation expense | $ 365,000 | ||
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options exercised during the period | 0 | ||
Options granted | 614,946 | ||
Unvested Stock Options and Stock Purchases [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation expense related to unvested stock options and stock purchases | $ 2,046,000 | ||
Weighted average period over which unrecognized compensation costs expected to be recognized | 1 year 4 days | ||
Officer [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options granted | 360,000 | ||
Officer [Member] | Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Accrued bonuses outstanding | $ 445,000 |
Stock-Based Compensation and 31
Stock-Based Compensation and Stock Options and Awards - Schedule of Activity Under Stock Option Plan - Shares Available for Future Grant (Detail) - Stock Options [Member] | 3 Months Ended |
Mar. 31, 2017shares | |
Shares Available for Future Grant | |
Balance at January 1, 2017 | 1,510,272 |
Options granted | (614,946) |
Options cancelled | 2,701 |
Balance at March 31, 2017 | 898,027 |
Stock-Based Compensation and 32
Stock-Based Compensation and Stock Options and Awards - Schedule of Activity Under Stock Option Plan - Options Outstanding (Detail) - Stock Options [Member] | 3 Months Ended |
Mar. 31, 2017USD ($)$ / sharesshares | |
Number of Shares | |
Outstanding at January 1, 2017 | shares | 1,923,595 |
Options granted | shares | 614,946 |
Options cancelled | shares | (2,701) |
Outstanding at March 31, 2017 | shares | 2,535,840 |
Exercisable at March 31, 2017 | shares | 1,030,011 |
Weighted Average Exercise Price | |
Outstanding at January 1, 2017 | $ / shares | $ 6.86 |
Options granted | $ / shares | 1.98 |
Options cancelled | $ / shares | 49.20 |
Outstanding at March 31, 2017 | $ / shares | 5.65 |
Exercisable at March 31, 2017 | $ / shares | $ 6.57 |
Weighted Average Remaining Contractual Term | |
Outstanding at March 31, 2017 | 8 years 6 months 4 days |
Exercisable at March 31, 2017 | 8 years 4 days |
Aggregate Intrinsic Value | |
Outstanding at March 31, 2017 | $ | $ 0 |
Exercisable at March 31, 2017 | $ | $ 0 |
Stock-Based Compensation and 33
Stock-Based Compensation and Stock Options and Awards - Schedule of Unvested Restricted Stock Award Activities (Detail) - Restricted Stock [Member] | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Number of Shares | |
Outstanding at January 1, 2017 | shares | 152,238 |
Restricted stock awards vested | shares | (4,688) |
Outstanding at March 31, 2017 | shares | 147,550 |
Weighted Average Grant Date Fair Value | |
Outstanding at January 1, 2017 | $ / shares | $ 3.96 |
Weighted Average Grant Date Fair Value, vested | $ / shares | 4.04 |
Outstanding at March 31, 2017 | $ / shares | $ 3.96 |
Net Loss and Comprehensive Lo34
Net Loss and Comprehensive Loss Per Common Share - Schedule of Securities Excluded from Calculation of Diluted Net Loss per Common Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Common Shares Underlying Convertible Notes [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 4,289 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 2,536 | 995 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 148 | 166 |
Unvested Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 10 | 10 |
Common Shares Underlying Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 263 | 71 |