Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 12, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ARDM | ||
Entity Registrant Name | ARADIGM CORP | ||
Entity Central Index Key | 1,013,238 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Common Stock, Shares Outstanding | 15,170,200 | ||
Entity Public Float | $ 7,658,222 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 7,095 | $ 22,591 |
Restricted cash | 0 | 1,006 |
Receivables | 200 | 167 |
Prepaid and other current assets | 389 | 1,037 |
Total current assets | 7,684 | 24,801 |
Property and equipment, net | 289 | 253 |
Other assets | 92 | |
Total assets | 8,065 | 25,054 |
Current liabilities: | ||
Accounts payable | 903 | 711 |
Accrued clinical and cost of other studies | 274 | 3,306 |
Accrued compensation | 1,643 | 1,335 |
Deferred revenue - related party, current | 1,900 | |
Deferred revenue-other | 183 | |
Other accrued liabilities | 563 | 496 |
Total current liabilities | 5,466 | 5,848 |
Deferred rent | 32 | |
Deferred revenue-related party, non-current | 90 | 5,000 |
Convertible debt, net of discount | 2,382 | 2,212 |
Convertible debt- related party, net of discount | 12,626 | 11,007 |
Total liabilities | 20,596 | 24,067 |
Commitments and contingencies (Note 16) | ||
Shareholders' equity (deficit): | ||
Preferred stock, 5,000,000 shares authorized, none outstanding | ||
Common stock, no par value; authorized shares: 35,045,765 at December 31, 2017; 35,045,765 at December 31, 2016; issued and outstanding shares:15,170,200 at December 31, 2017; 14,951,089 at December 31, 2016 | 442,639 | 439,406 |
Accumulated deficit | (455,170) | (438,419) |
Total shareholders' equity (deficit) | (12,531) | 987 |
Total liabilities and shareholders' equity (deficit) | $ 8,065 | $ 25,054 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 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 | 15,170,200 | 14,951,089 |
Common stock, shares outstanding | 15,170,200 | 14,951,089 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue: | ||
Contract revenue - related party (Note 9) | $ 14,075 | $ 40 |
Contract revenue | 268 | 116 |
Grant revenue | 122 | 39 |
Total revenues | 14,465 | 195 |
Operating expenses: | ||
Research and development | 13,815 | 24,387 |
General and administrative | 7,592 | 5,828 |
Restructuring and asset impairment | 2 | |
Total operating expenses | 21,407 | 30,217 |
Loss from operations | (6,942) | (30,022) |
Interest income | 92 | 88 |
Interest expense | (3,870) | (2,406) |
Other income (expense), net | 15 | (598) |
Income (net loss and comprehensive loss) | $ (10,705) | $ (32,938) |
Basic and diluted net income (loss) per common share | $ (0.72) | $ (2.23) |
Shares used in computing basic and diluted net loss per common share | 14,860 | 14,779 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2015 | $ 23,110 | $ 428,591 | $ (405,481) |
Beginning Balance, Shares at Dec. 31, 2015 | 14,761,351 | ||
Issuance of common stock under the employee stock purchase plan | 104 | $ 104 | |
Issuance of common stock under the employee stock purchase plan, Shares | 23,738 | ||
Issuance of restricted stock | 0 | $ 0 | 0 |
Issuance of restricted stock, Shares | 166,000 | ||
Reclassification of derivative liability to equity | 8,362 | $ 8,362 | |
Reclassification of derivative liability to equity, Shares | 0 | ||
Reclassification of warrants to equity | 11 | $ 11 | |
Reclassification of warrants to equity, Shares | 0 | ||
Issuance of warrants with convertible notes | 662 | $ 662 | |
Issuance of warrants with convertible notes, Shares | 0 | ||
Stock-based compensation expense for stock options, restricted stock and restricted stock units | 1,676 | $ 1,676 | |
Net loss | (32,938) | (32,938) | |
Ending Balance at Dec. 31, 2016 | 987 | $ 439,406 | (438,419) |
Ending Balance, Shares at Dec. 31, 2016 | 14,951,089 | ||
Issuance of common stock under the employee stock purchase plan | 103 | $ 103 | |
Issuance of common stock under the employee stock purchase plan, Shares | 78,949 | ||
Issuance of restricted stock | 0 | $ 0 | 0 |
Issuance of restricted stock, Shares | 118,100 | ||
Exercise of Options | 47 | $ 47 | |
Exercise of Options,Shares | 22,062 | ||
Stock issued in payment of officer bonus | 444 | $ 444 | |
Stock-based compensation expense for stock options, restricted stock and restricted stock units | 2,618 | 2,618 | |
Net loss | (10,705) | (10,705) | |
Ending Balance at Dec. 31, 2017 | (12,531) | $ 442,639 | (455,170) |
Ending Balance, Shares at Dec. 31, 2017 | 15,170,200 | ||
Adoption of Accounting Standards | ASC 606 [Member] | $ (6,025) | (6,025) | |
Adoption of Accounting Standards | Accounting Standards Update 2016-09 [Member] | $ 21 | $ (21) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (10,705) | $ (32,938) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 118 | 121 |
Stock-based compensation expense | 2,618 | 1,676 |
Amortization of convertible debt discount | 1,788 | 1,057 |
Financing costs, derivative liability and warrants | 997 | |
Change in value of derivative liability | (386) | |
Changes in operating assets and liabilities: | ||
Receivables | (33) | (17) |
Prepaid and other current assets | 648 | 2,597 |
Other assets | (92) | 81 |
Accounts payable | 193 | (1,078) |
Accrued compensation | 752 | 176 |
Current deferred revenue - related party | (8,852) | |
Accrued liabilities | (2,965) | (625) |
Deferred rent | 32 | (37) |
Deferred revenue - related party, non-current | 0 | 0 |
Facility lease exit obligation | (104) | |
Net cash used in operating activities | (16,498) | (28,480) |
Cash flows from investing activities: | ||
Transfer to/from restricted cash, net | 1,006 | (1,006) |
Capital expenditures | (154) | (75) |
Net cash provided by (used in) investing activities | 852 | (1,081) |
Cash flows from financing activities: | ||
Proceeds from issuance of convertible debt | 3,050 | |
Proceeds from issuance of convertible debt - related party | 19,950 | |
Proceeds from issuance of common stock | 150 | 104 |
Payments for financing costs | (2,414) | |
Net cash provided by financing activities | 150 | 20,690 |
Net decrease in cash and cash equivalents | (15,496) | (8,871) |
Cash and cash equivalents at beginning of year | 22,591 | 31,462 |
Cash and cash equivalents at end of year | 7,095 | 22,591 |
Cash paid for interest | 2,070 | 1,005 |
Cumulative effect of adoption of new accounting standards | 6,046 | |
Stock issued in payment of officer bonus | $ 444 | |
Non-cash disclosure of financing activities: | ||
Reclassification of derivative liability to equity | 8,362 | |
Reclassification of warrants to equity | 11 | |
Debt discount from warrants | $ 662 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies 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 upcoming year. The Company operates as a single operating segment. Basis of Presentation and Consolidation The accompanying 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. Certain prior period amounts have been conformed to the current period’s presentation. 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) Form 10-K reflect Liquidity and Financial Condition The Company has incurred significant operating losses and negative cash flows from operations. At December 31, 2017, the Company had an accumulated deficit of approximately $455.2 million, working capital of approximately $2.2 million and shareholders’ deficit of approximately $12.5 million. Management expects operating losses to continue for the foreseeable future. As a result of expected losses and negative cash flows from operations, along with the Company’s cash position of $7.1 million at December 31, 2017, the Company will have sufficient resources to fund operations for the first quarter of 2018. The Company will need to raise additional capital through issuance of debt or equity securities, royalty financing transactions, strategic transactions or otherwise, to fund the Company’s operations and continue development of the Company’s lead product candidate Linhaliq in early 2018. No assurance can be given that the Company will be successful in raising such additional capital on favorable terms or at all. If the Company is unable to obtain additional funds when required, it will delay or reduce the scope of all or a portion of its development programs or dispose of assets or technology, and if not achieved on a timely basis would materially harm its business, financial condition and results of operations or require the Company to dispose of its assets or technology or to cease operations, and the Company may not be able to continue as a going concern. For more information, see “Note 15: Going Concern.” Use of Estimates The preparation of financial statements, in conformity with generally accepted accounting principles or 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, accruals for operating expenses, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. 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 Consolidated Statement of Cash Flows based on the nature of the restriction. As of December 31, 2016, the Company had $1.0 million in restricted cash held in an interest-bearing escrow account for the purpose of making interest payments on the Convertible Notes, as outlined in Note 7 below. The Company was required to maintain such deposits sufficient to pay all required payments of interest through May 1, 2017. On December 31, 2017, the restricted cash balance is zero. 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 include external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software include 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. The standard estimated useful lives of property and equipment are as follows: Computer equipment and software 3 years Furniture and fixtures 7 years Lab equipment 5 years Machinery and equipment 5 years Leasehold improvements 5 years Impairment of Long-Lived Assets The Company reviews for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values, and the loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss. Convertible Instruments The Company accounts for hybrid contracts that feature conversion options in accordance with GAAP. ASC 815, Derivatives and Hedging Activities 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 has followed the provisions of ASC Topic 606, Revenue from Contracts with Customers 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 consideration. Non-refundable In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. 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. The Company’s performance obligations include license rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is 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 As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation 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 an income approach model and include the following key assumptions: the development timeline, revenue forecast, commercialization expenses, discount rate and probabilities of technical and regulatory success. To estimate selling prices for development services, regulatory submission services, and product supply, the Company uses a cost plus margin approach. Licenses of intellectual property: from non-refundable, up-front fees from non-refundable, up-front fees. The Milestone payments: Royalties: 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. Arrangements that include a promise for the future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, the material rights are accounted for as separate performance obligations. Payments associated with optional items are allocated to the performance obligations in the separate contract. If the Company is entitled to additional payments for performance obligations in the original arrangement when the customer exercises these options, any additional payments are allocated to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in license, collaboration, and other revenues when the customer obtains control of the goods or services. 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. 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 re-measured into 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 year ended December 31, 2017, the Company offset its research and development costs by approximately $1 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 ASC 505-50, 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 the 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 its income taxes in each of the jurisdictions in which it operates. This process involves the estimation of the 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 its 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, it will record a valuation allowance against the deferred tax assets that it estimates will not ultimately be recoverable. At December 31, 2017 and 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, it 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 shares subject to repurchase. Diluted net income/(loss) per common share is based on the weighted average number of common and common share equivalents, such as stock options and unvested restricted stock shares outstanding during the period. Potentially dilutive securities were not included in the net loss per common share calculation for the years ended December 31, 2017 and 2016 because the inclusion of such shares would have had an anti-dilutive effect. Refer to Note 11 for a summary of the anti-dilutive securities. Significant Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments. Risks associated with these instruments are mitigated by banking with, and only purchasing commercial paper and corporate notes from, creditworthy institutions. The maximum amount of loss due to credit risk associated with these financial instruments is their respective fair values as stated in the accompanying Consolidated Balance Sheets. Comprehensive Income (Loss) ASC 220, Comprehensive Income non-owner available-for-sale Accounting Changes In May 2014, the Financial Accounting Standards Board or 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. See Note 8 for further details. In March 2016, the FASB issued Accounting Standards Update, or ASU 2016-09, Improvements to Employee Share-Based Payment Accounting Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) |
Cash and Cash Equivalents
Cash and Cash Equivalents | 12 Months Ended |
Dec. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | 2. Cash and Cash Equivalents At December 31, 2017 and 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 | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 3. Fair Value Measurements The Company follows ASC 820, Fair Value Measurement The Company’s cash and cash equivalents at December 31, 2017 and 2016, consist of cash and money market funds. Money market funds are valued using quoted market prices. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2017 2016 Machinery and equipment $ 4,382 $ 4,363 Furniture and fixtures 592 578 Lab equipment 1,449 1,446 Computer equipment and software 1,874 1,821 Leasehold improvements 1,799 1,734 Property and equipment 10,096 9,942 Less accumulated depreciation and amortization (9,807 ) (9,689 ) Property and equipment, net $ 289 $ 253 Depreciation expense was $118,000 and $121,000 for the years ended December 31, 2017 and 2016, respectively. In 2016, the Company retired $2.7 million in assets that were no longer in service. |
Sublease Agreement and Lease Ex
Sublease Agreement and Lease Exit Liability | 12 Months Ended |
Dec. 31, 2017 | |
Restructuring and Related Activities [Abstract] | |
Sublease Agreement and Lease Exit Liability | 5. Sublease Agreement and Lease Exit Liability: On July 18, 2007, the Company entered into a sublease agreement with Mendel, to lease approximately 48,000 square feet of the Company’s 72,000 square foot headquarters facility located in Hayward, California which ended in July 2016. During the year ended December 31, 2007, the Company recorded a $2.1 million lease exit liability and related expense for the expected loss on the sublease, in accordance with ASC 420 Exit or Disposal Cost Obligations, Year Ended December 31, 2017 2016 Balance at the beginning of year $ — $ 104 Accretion expense — 2 Lease payments — (106 ) Balance at the end of the year $ — $ — As of December 31, 2017 and 2016, the Company had no lease liability. |
Other Accrued Liabilities
Other Accrued Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | 6. Other Accrued Liabilities At December 31, 2017, other accrued liabilities consisted of accrued expenses for interest of $345,000, expenses for services of $132,000 and payroll withholding liabilities of $86,000. The liability for accrued interest of $345,000 is related to the Convertible Notes as outlined in Note 7 and represents the interest on the Convertible Notes that is accrued but unpaid as of December 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 | 12 Months Ended |
Dec. 31, 2017 | |
Text Block [Abstract] | |
Convertible Notes and Warrants | 7. 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. The Convertible Notes are initially convertible into the Company’s common stock at a conversion rate of 191.9386 shares of common stock per $1,000 principal amount of Convertible Notes, representing an initial effective conversion price of $5.21 per share of common stock. The conversion rate may be subject to adjustment upon the occurrence of certain specified events as provided in the indenture governing the Convertible Notes, dated April 25, 2016, between the Company and U.S. Bank National Association, as trustee, or the Indenture, but will not be adjusted for accrued but unpaid interest. Upon conversion of a Convertible Note, the Company will settle the conversion obligation in common stock equal to the conversion rate, together with a cash payment, if applicable. The Convertible Notes are convertible at the option of the holders at any time prior to April 29, 2021. Holders of the Convertible Notes who convert their Convertible Notes in connection with a make-whole fundamental change, as defined in the Indenture, may be entitled to a make-whole premium in the form of an increase to the conversion rate during a specified period following the effective date of the make-whole fundamental change. In addition, upon the occurrence of a fundamental change prior to the maturity date of the Convertible Notes, as defined in the Indenture, holders of the Convertible Notes may require the Company to purchase all or a portion of their Convertible Notes for cash at a price equal to 100% of the principal amount of the Convertible Notes to be purchased plus any accrued but unpaid interest to, but excluding, the fundamental change purchase date. 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. The Warrants are exercisable commencing on the later of October 25, 2016, and the date of the public release of top-line ORBIT-3 ORBIT-4 top-line In accounting for the Convertible Notes and Warrants in the first closing, the Company bifurcated a derivative liability from the debt host and discounted the Convertible Notes for the estimated fair value of the conversion feature and the freestanding Warrants issued in connection with the Convertible Notes. The liability components were measured by estimating their fair value as of the commitment date. On June 9, 2016, the Company obtained Shareholder Approval for the Convertible Notes, the Warrants and the underlying shares, at which point the Conversion Share Cap on the Convertible Notes was lifted. As a result, the bifurcated derivative and warrant liability met the equity classification criteria under ASC 815-40-25, non-cash 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 9 below. 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 Company deposited $1.8 million of the net proceeds into an escrow account after the initial closing to fund, when due, the first two scheduled semi-annual interest payments on the Notes. The effective interest rate of the liability component was equal to 22.9% for the year ended December 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 Company deposited $215,000 of the net proceeds into an escrow account after the second closing to fund, when due, the first two scheduled semi-annual interest payments on the Convertible Notes. The effective interest rate of the liability component was equal to 16.24% for the year ended December 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 In connection with the first closing, the derivative and warrant liabilities were measured at fair value using certain estimated inputs, which are classified within Level 3 of the valuation hierarchy. The following assumptions were used in the Black-Scholes Model to measure the fair value of the derivative and warrant liability as of June 9, 2016 (the date of the shareholder vote) and April 21, 2016 (the date of the first closing): June 9, 2016 April 21, 2016 Fair value of underlying stock—per share $ 4.48 $ 4.55 Risk-free interest rate 1.20 % 1.35 % Expected life (years) 4.9 5 Expected volatility 73.16 % 73.95 % Dividend yield 0.0 % 0.0 % The following table summarizes the activity in the derivative liability and the warrant liability for the year ended December 31, 2016: Year Ended December 31, 2016 Fair Value Fair Value of Change Reclassifications to Equity Fair Value 2016 Derivative liability $ — $ 8,748 $ (386 ) $ (8,362 ) $ — Warrant liability — 11 — (11 ) — Total $ — $ 8,759 $ (386 ) $ (8,373 ) $ — For the year December 31, 2016, the Company recognized a gain of $386,000 and $500 on the derivative and warrant liabilities, respectively, related to the change in fair value from the date of commitment to the date the instruments met the equity classification criteria on June 9, 2016, at which point $8.4 million was reclassified from liabilities to equity. The gain has been recorded in other expense in the Consolidated Statement of Operations and Comprehensive Loss. In connection with the second closing, the Warrants issued as a component of equity were measured at fair value using certain estimated inputs, which are classified within Level 3 of the valuation hierarchy. The following assumptions were used in the Black-Scholes Model to measure the fair value of the Warrants as of July 14, 2016: July 14, 2016 Fair value of underlying stock—per share $ 4.58 Risk-free interest rate 1.07 % Expected life (years) 4.78 Expected volatility 72.87 % Dividend yield 0.0 % As of December 31, 2017 and 2016, the Convertible Notes consisted of the following: December 31, 2017 December 31, 2016 (in thousands, except conversion rate and conversion price) Principal value $ 23,000 $ 23,000 Unamortized debt discount (6,948 ) (8,501 ) Unamortized debt issuance costs (1,044 ) (1,280 ) Carrying value of the convertible notes $ 15,008 $ 13,219 Conversion rate (shares of common stock per $1,000 principal amount of notes) 191.9386 191.9386 Conversion price (per share of common stock) $ 5.21 $ 5.21 For the years ended December 31, 2017 and 2016, the Company recognized interest expense associated with its Convertible Notes as follows: Year ended December 31, 2017 Year ended December 31, 2016 (in thousands) Cash Interest Expense Coupon interest expense $ 2,070 $ 1,349 Other interest expense 12 — Noncash Interest Expense Amortization of debt discount 1,552 920 Amortization of transaction costs 236 137 $ 3,870 $ 2,406 As of December 31, 2017, the unamortized debt discount will be amortized over a remaining period of approximately 3.34 years. The if-converted |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2017 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | 8. Revenue Recognition Adoption of ASC Topic 606, “Revenue from Contracts with Customers” On January 1, 2017, the Company adopted ASC Topic 606 using the modified retrospective method applied to those contracts which were not completed as of January 1, 2017. Results for reporting periods beginning after January 1, 2017, are presented under ASC Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting under ASC Topic 605. The adoption of the new revenue recognition guidance resulted in increases of $6.0 million in deferred revenue and the accumulated deficit as of January 1, 2017. For the year ended December 31, 2017, revenue increased by $9.4 million for services performed in the period which under the prior milestone recognition methodology, would not be recognized until the milestones are substantively achieved. In addition, revenue increased by an additional $4.5 million for research and development services milestone payments received in the period that were allocated to regulatory submission and approval services performed in the period. For the year ended December 31, 2017, net loss decreased by $13.9 million and basic and diluted net loss per share decreased by $0.94 per share as a result of the adoption of Topic 606. The following table shows the reconciliation of Contract Liabilities from what was disclosed in the Form 10-K Deferred Revenue, balance at December 31, 2016 $ 5,000 Changes in estimated consideration — Unsatisfied performance obligations 6,026 Deferred Revenue, balance at January 1, 2017 $ 11,026 Revenue Recognition Revenues are recognized for services as they are satisfied over time, and the Company recognizes revenue for licenses of functional intellectual property at the point in time the customer can use and benefit from the license. For additional detail on the Company’s accounting policy regarding revenue recognition, refer to Note 1 above. The following table presents changes in the Company’s contract assets and liabilities for the year ended December 31, 2017. Balance at of the Year Additions Deductions Balance at the end of the Year (in thousands) Contract Assets $ — $ 67 $ — $ 67 Contract Liabilities: Deferred Revenue $ 11,026 $ 5,411 $ (14,264 ) $ 2,173 Deferred revenues allocated to unsatisfied performance obligations will be recognized over time as the services are performed, which is expected to take place in 2018 and 2019. Sales-based royalties, including milestone payments based on the level of sales, related to license arrangements are excluded from variable consideration and will be recognized at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. The Company has elected to exclude providing further disclosure about sales-based royalties in accordance with ASC Topic 606-10-50-14A. Milestone payments that are not considered probable of being achieved are excluded from the transaction price until those approvals are received. As a result, amounts that would be allocated to unsatisfied performance obligations for such milestone payments are excluded from Contract Assets and Contract Liabilities. During the year ended December 31, 2017, the Company recognized the following revenues (in thousands). Revenue recognized in the period from: Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied $ 9,167 New activities in the period: Changes in the estimated transaction price allocated to performance obligations satisfied in prior periods 4,527 Performance obligations satisfied from new activities in the current period—contract revenue 649 Performance obligations satisfied from new activities in the current period—grant revenue 122 Total revenue $ 14,465 |
Collaboration Agreement
Collaboration Agreement | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreement | 9. Collaboration Agreement Grifols License and Collaboration Agreement In 2013, the Company and Grifols, S.A., or Grifols and certain other investors, or the Investors, entered into a Stock Purchase Agreement, or the Grifols Stock Purchase Agreement, pursuant to which the Company agreed, subject to the terms and conditions set forth in the Stock Purchase Agreement, to issue and sell shares of the Company’s common stock, or Common Stock, to Grifols and additional shares of Common Stock to the Investors. In conjunction with signing the Grifols Stock Purchase Agreement, the Company and Grifols agreed to enter into a License and Collaboration Agreement, or the Grifols License Agreement, at the closing of the Company Stock Sale; Grifols and the Company are considered to be related parties, and as a result, all transactions between the two entities are recognized as related party transactions. The License Agreement exclusively licenses the Company’s inhaled liposomal ciprofloxacin compounds for the indication of non-cystic non-cystic The Company determined this transaction was not within the scope of ASC 605-25. License Agreement The License Agreement was signed simultaneously with the closing of the Company Stock Sale in 2013. Under the License Agreement, the Company granted to Grifols an exclusive license to the Program, the lead product candidate of which is named Linhaliq. The license permits Grifols to commercialize Products throughout the world and grants Grifols a back-up The Company is responsible for developing the Product for non-cystic non-cystic The Company is responsible for obtaining regulatory approval of the first indication for the Product in the United States and the European Union. Grifols is responsible for additional regulatory expenses, including the cost of obtaining approval outside the United States and European Union, and the cost of maintaining approvals globally. Grifols is responsible for using diligent efforts to commercialize the Product in countries where regulatory approval has been obtained. The Company is responsible for supplying Grifols’ requirements of the Product and must establish primary and back-up The collaboration between Grifols and the Company is governed by a joint committee comprised of equal representation by the Company and Grifols and operated on a consensus basis. In the event that the parties do not agree, Grifols has deciding authority, except with respect to specific matters specified in the License Agreement. The Company has no obligation to participate in the joint committee after the first commercial sale of the product but may do so at its discretion. Accordingly, the Company determined that it can separate performance obligations that occur over the development period from performance obligations that will occur during the commercialization period. With respect to the US and EU development and approval of Linhaliq for non-cystic country-by-country country-by-country Prior to the adoption of ASC Topic 606, under ASC Topic 605, the Company recognized reimbursements of development expenses as collaboration services were performed and costs were incurred. During the year ended December 31, 2016, the Company recognized no contract revenue – related party relating to services performed and costs incurred during the period under the License Agreement as the Company had utilized the full $65 million of the Grifols-funded budget provided under the License Agreement. In addition, the Company’s current deferred revenue balance at December 31, 2016, was $5.0 million, representing a milestone payment which was received upon the dosing of the first patient in a Phase III clinical trial. Upon adoption of ASC Topic 606 as of January 1, 2017, the Company deferred $6.0 million for the portion of the Grifols 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 a result of adoption, an additional $14.0 million of Grifols contract revenue was recognized for performance obligations satisfied during the year ended December 31, 2017, including the $5.0 million milestone payment received during 2017, which under the prior milestone recognition methodology would not have been recognized since the milestone is not considered to be substantively achieved until regulatory approval is achieved. The Company’s performance obligations include those related to the worldwide license to commercialize products developed from the collaboration development services for Phase 3 clinical trials that were completed as of December 31, 2016, regulatory submission services for the first indication that were complete as of September 30, 2017, and regulatory approval services in the US and EU for the first indication. In addition, the Company identified that Grifols has an option that will create manufacturing obligations for the Company upon exercise by the customer. Further, these customer options for manufacturing services were evaluated and did not include a material right. Under the License Agreement, the Company is eligible to receive up to $25.0 million in payments upon the achievement of regulatory filing and approval milestones. As of December 31, 2017, the Company has achieved two of the six milestones and has received $10.0 million in payments. Milestone payments related to regulatory submission and approval services are considered variable consideration and excluded from the transaction price as of the date of adoption. In the second quarter of 2017, the Company determined that the $5.0 million milestone payment associated with NDA submission (the first regulatory filing) is probable and updated the estimated transaction price accordingly. The milestone payment was allocated to the performance obligations based upon relative estimated selling prices resulting in recognition of $4.5 million for performance obligations that had been satisfied in prior periods. Milestone payments related to regulatory approval services have been excluded from the transaction price for the year ended December 31, 2017 due to the constraint on variable consideration. The Company recognizes revenue from license rights when the customer can use and benefit from the license rights. The Company recognizes revenue from its services performance obligations over time using a cost-to-cost input The Company has deferred $2.0 million of the transaction price in the Grifols’ arrangement that is allocated to the performance obligations that are unsatisfied (or partially unsatisfied) as of December 31, 2017. Governance Agreement The Grifols Governance Agreement sets forth certain rights and obligations of the Company and Grifols concerning, among other things, certain corporate governance matters, certain limitations on future acquisitions of shares of Common Stock by Grifols, and certain rights by Grifols to maintain a target level of ownership in the Company. On the date the Grifols Governance Agreement was executed, the Company’s board of directors was reconstituted to consist of its chief executive officer, three independent directors under the Nasdaq Marketplace Rules and two persons designated by Grifols. The number of persons Grifols is entitled to designate for consideration for election to the Company’s board of directors by the Company’s nominating committee will thereafter depend on the percentage of beneficial ownership of the Company held by Grifols. The Grifols Governance Agreement also provides that during the period beginning on the date of Closing and ending 12 months after the first commercial sale of a Product, or the Restricted Period, Grifols will not directly or indirectly acquire or offer to acquire any shares of Common Stock except (i) with the approval of the Company’s board of directors and a majority of its independent directors, (ii) effected solely to the extent necessary to maintain the beneficial ownership of Grifols and its affiliates at an amount equal to 35%, or the Target Percentage, of the shares of Common Stock on a Fully Diluted Basis (as defined in the Governance Agreement), or (iii) in order to maintain its ownership percentage in the event that the Company issues new securities, in accordance with the provisions of the Governance Agreement. In conjunction with the Note Financing, the Grifols Governance Agreement was amended to raise the Target Percentage to 43.3%. The Restricted Period terminates upon the occurrence of certain events, including a change in control of the Company and a third party publicly proposing to acquire the Company. The Governance Agreement further imposes certain “standstill” obligations on Grifols during the Restricted Period, pursuant to which Grifols and certain related persons are prohibited from soliciting proxies from the Company’s shareholders, granting proxies or entering into voting agreements and seeking additional representation on the Company’s Board of Directors. The Grifols Governance Agreement provides Grifols with certain preemptive rights to participate in future issuances of Common Stock or equivalents of Common Stock by the Company, or the right to acquire shares of Common Stock from third parties or on the open market to maintain its Fully Diluted Ownership at the Target Percentage. The Grifols Governance Agreement requires the approval of Grifols for certain actions by the Company which would adversely affect Grifols’ rights under the Governance Agreement, and for the Company to terminate the employment of its Chief Executive Officer or to appoint any successor Chief Executive Officer. Registration Rights Agreements In connection with and concurrently with the closing of the Company Stock Sale, the Company entered into a Registration Rights Agreement with Grifols, or the Grifols Registration Rights Agreement, pursuant to which the Company agreed to provide registration rights to Grifols with respect to the shares of Common Stock to be acquired in the Company Stock Sale. Under such agreement, Grifols is entitled to require the Company to file with the SEC certain registration statements under the Securities Act of 1933, as amended, or the Securities Act, with respect to the resale of the shares of Common Stock acquired by Grifols in the Company Stock Sale up to three times on Form S-1 S-3, |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Shareholders' Equity | 10. Shareholders’ Equity Shareholder Rights Plan In September 2008, the Company adopted an amended and restated shareholder rights plan, which replaced the rights plan originally adopted in August 1998. Pursuant to the rights plan, as amended and restated, the Company distributes rights to purchase shares of Series A Junior Participating Preferred Stock as a dividend at the rate of one right for each share of common stock outstanding. Until the rights are distributed, the rights trade with, and are not separable from, the Company’s common stock and are not exercisable. The rights are designed to guard against partial tender offers and other abusive and coercive tactics that might be used in an attempt to gain control of the Company or to deprive the Company’s shareholders of their interest in the Company’s long-term value. The shareholder rights plan seeks to achieve these goals by encouraging a potential acquirer to negotiate with the Company’s Board of Directors. The rights will expire at the close of business on September 8, 2018. Stock Option Plans: 2005 Equity Incentive Plan, and 2015 Equity Incentive Plan On March 13, 2015 the Board adopted and, on May 14, 2015 the Company’s shareholders approved, the 2015 Equity Incentive Plan, or the 2015 Plan. The 2015 Plan replaces the Company’s 2005 Equity Incentive Plan, or 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 Options granted under the 2005 Plan and the 2015 Plan expire no later than 10 years from the date of grant and may be either incentive or non-statutory non-statutory Options granted under the 2005 Plan and the 2015 Plan may be immediately exercisable if permitted in the specific grant approved by the Board of Directors and, if exercised early may be subject to repurchase provisions. The shares acquired generally vest over a period of four years from the date of grant. Both Plans also provides for a transition from employee to consultant status without termination of the vesting period as a result of such transition. Under both Plans, employees may exercise options in exchange for a note payable to the Company, if permitted under the applicable grant. As of December 31, 2017 and 2016, there were no outstanding notes receivable from shareholders. Any unvested stock issued is subject to repurchase agreements whereby the Company has the option to repurchase unvested shares upon termination of employment at the original issue price. The common stock subject to repurchase has voting rights, but cannot be resold prior to vesting. No grants with early exercise provisions have been made under the 2005 Plan or 2015 Plan and no shares have been repurchased. The following is a summary of activity (time- and performance-based) under the 2005 Plan and the 2015 Plan for the year ended December 31, 2017: Shares Available for Balance at January 1, 2017 1,510,272 Increase in authorized shares 2,500,000 Options granted (2,041,901 ) Options cancelled 215,853 Restricted stock awards granted (539,100 ) Balance at December 31, 2017 1,645,124 Stock Options Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at January 1, 2017 1,923,595 $ 6.86 Options granted 2,041,901 $ 3.29 Options exercised (22,062 ) $ 2.12 Options cancelled (215,853 ) $ 10.53 Outstanding at December 31, 2017 3,727,581 $ 4.72 8.27 $ 8,763,440 Ending exercisable 1,634,831 $ 4.76 7.30 $ 3,909,557 The weighted-average grant-date fair value of options granted during the years ended December 31, 2017 and 2016 is discussed below under “ Valuation Assumptions A summary of the activity of the Company’s unvested restricted stock and performance-based restricted stock award activities for the year ended December 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 Average Grant Date Fair Value Outstanding at January 1, 2017 152,238 $ 3.96 Restricted stock awards granted 539,100 1.39 Restricted stock awards vested (77,800 ) 2.03 Outstanding at December 31, 2017 613,538 $ 1.95 Recipients of restricted stock do not pay cash consideration for the shares and have the right to vote all shares subject to the grant. The weighted average grant date fair value of restricted stock awards is based on the closing price of the Company’s common stock on the date of grant. The total fair value of restricted stock awards that vested during the years ended December 31, 2017 and 2016 was $213,000 and $53,000 respectively. Restricted Stock Units Number of Shares Weighted Average Grant Date Fair Value Outstanding at January 1, 2017 10,306 $ 5.34 Restricted stock units granted — — Restricted stock units vested — — Outstanding at December 31, 2017 10,306 $ 5.34 As of December 31, 2017, there was no unrecognized compensation cost related to restricted stock unit arrangements granted under the Plans. The total fair value of shares vested during the years ended December 31, 2017 and 2016 was zero for both years. Performance-based Stock Options During the year ended December 31, 2017, the Company granted to certain executives 460,000 performance-based stock options with a weighted average exercise price of $4.02. These performance-based stock options have a contractual term of ten years and vesting is dependent upon meeting certain specified company-wide performance goals. The weighted average grant date fair value of these performance-based stock options is discussed below under “ Valuation Assumptions During the year ended December 31, 2016, the Company granted to certain executives 595,000 performance-based stock options with a weighted average exercise price of $4.09 (contingent upon shareholder approval which was received in June 2016). These performance-based stock options have a contractual term of ten years and vesting is dependent upon meeting certain specified company-wide performance goals. The weighted average grant date fair value of these performance-based stock options is discussed below under “ Valuation Assumptions Performance-based Restricted Stock Awards During the year ended December 31, 2017, the Company granted to certain executives 421,000 performance-based restricted stock awards or PRSAs with a weighted average fair value of $1.39. Vesting in these PRSAs is dependent upon meeting a certain specified company-wide performance goal. No stock-based compensation expense related to these PRSAs has been recognized during the year ended December 31, 2017, as the performance-based goal was not deemed to have been probable of being achieved during the period. Employee Stock Purchase Plan Employees generally are eligible to participate in the ESPP if they have been continuously employed by the Company for at least 10 days prior to the first day of the offering period and are customarily employed at least 20 hours per week and at least five months per calendar year and are not a 5% or greater shareholder. Shares may be purchased under the ESPP at 85% of the lesser of the fair market value of the common stock on the grant date or purchase date. Employee contributions, through payroll deductions, are limited to the lesser of 15% of earnings or $25,000. As of December 31, 2017, a total of 486,250 shares have been reserved for issuance under the ESPP, of which 274,644 shares have been issued to participants leaving a remaining balance of 211,606 available authorized shares. Compensation expense related to the ESPP was $105,000 and $73,000 for the years ended December 31, 2017 and 2016, respectively. The fair value of employee stock purchase rights under the ESPP is discussed below under “ Valuation Assumptions Stock-Based Compensation Expense The Company recognizes stock-based compensation expense based on the fair value of that portion of stock options and restricted stock awards that are ultimately expected to vest during the period. Stock-based compensation expense recognized in the Consolidated Statement of Operations and Comprehensive Loss includes compensation expense for stock-based awards based on the estimated grant date fair value over the requisite service period. The following table shows stock-based compensation expense included in the Consolidated Statement of Operations and Comprehensive loss for the years ended December 31, 2017 and 2016, (in thousands, except per share amounts): 2017 2016 Costs and Expenses Research and development $ 1,317 $ 826 General and administrative 1,301 850 Total stock-based compensation expense $ 2,618 $ 1,676 Impact on basic and diluted net loss per common share $ (0.18 ) $ (0.11 ) There was no capitalized stock-based compensation expense as of December 31, 2017. Since the Company has cumulative net losses through December 31, 2017, there was no tax benefit associated with stock-based compensation expense. The total amount of unrecognized compensation expense related to unvested stock options and stock purchases was $3,049,000 as of December 31, 2017. This amount will be recognized over a weighted average period of 1.3 years. As of December 31, 2017, there was $249,000 of unrecognized compensation expense related to unvested restricted stock awards that is expected to be recognized over a weighted average period of 0.3 years. There also was $184,000 of unrecognized compensation expense related to the current ESPP offering period as of December 31, 2017, which is expected to be recognized through March 31, 2019. Valuation Assumptions The fair value of stock options and employee stock purchase rights are estimated at the date of grant using the Black-Scholes option pricing model based on the following assumptions: Expected term non-employee two-year Expected volatility Risk-free interest rate Expected dividend yield The weighted average assumptions for employee service-based options (which for purposes of this table includes members of the board of directors) were as follows: Years Ended December 31 2017 2016 Dividend yield 0.0 % 0.0 % Volatility factor 81.1 % 74.0 % Risk-free interest rate 2.0 % 1.4 % Expected term (in years) 5.6 5.5 Weighted-average fair value of options granted during the periods $ 2.24 $ 3.13 The weighted average assumptions for performance-based options were as follows: Years Ended December 31, 2017 2016 Dividend yield 0.0 % 0.0 % Volatility factor 80.4 % 77.1 % Risk-free interest rate 2.1 % 1.5 % Expected term (in years) 5.2 5.7 Weighted-average fair value of options granted during the period $ 2.64 $ 2.68 The weighted average assumptions for employee stock purchase rights under the ESPP were as follows: Years Ended December 31, 2017 2016 Dividend yield 0.0 % N/A Volatility factor 81.7 % N/A Risk-free interest rate 1.2 % N/A Expected life (years) 2.0 N/A Weighted-average fair value of purchase rights granted during the period $ 0.90 N/A There were no employee stock purchase rights valued during the year ended December 31, 2016 as the previous offering period was valued on April 1, 2015 and was over a two-year The Company accounts for options issued to non-employees 505-50, Non-Employees, non-employee re-measured |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | 11. Net 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 restrictive are anti-dilutive and are not included in the diluted weighted average number of shares of common stock outstanding for the years ending December 31, 2017 and 2016. The Company excluded the following securities from the calculation of diluted net loss per common share for the years ended December 31, 2017 and 2016, as their effect would be anti-dilutive (in thousands): Year ended December 31, 2017 2016 Common shares underlying convertible notes 4,415 4,415 Outstanding stock options 3,728 1,924 Common shares underlying warrants 263 263 Unvested restricted stock 613 152 Unvested restricted stock units 10 10 |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2017 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 12. Employee Benefit Plans The Company provides a 401(k) Plan for all full-time employees. Employees can contribute on a pretax basis up to the 2017 statutory limit of $18,000 (plus an additional $6,000 for employees that are 50 years and older). The Company matches employees’ contributions up to a maximum of three percent of an employee’s annual salary based upon the employee’s contribution and certain other limitations. The Company’s employer matching contribution expense was $106,000 and $88,000 in 2017 and 2016, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. Income Taxes In 2017 and 2016, the Company recorded an income tax benefit of zero. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for tax purposes as well as net operating loss and tax credit carryforwards. Income (loss) before provision for income taxes consists as follows (in thousands) December 31, 2017 2016 United Sates $ (11,465 ) $ (31,594 ) International 760 (1,344 ) Total $ (10,705 ) $ (32,938 ) Significant components of the Company’s deferred tax assets and liabilities were as follows (in thousands): December 31, 2017 2016 Net operating loss carryforwards $ 18,267 $ 25,536 Research and development credits 7,898 6,509 Federal orphan drug credits 23,881 18,599 Other 1,483 3,572 Total deferred tax assets 51,529 54,216 Valuation allowance (51,529 ) (54,216 ) Net deferred tax assets $ — $ — The Company considers all available evidence, both positive and negative, including historical levels of taxable income, 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. At December 31, 2017 and 2016, based on the Company’s analysis of all available evidence, both positive and negative, it was considered more likely than not that the Company’s deferred tax assets would not be realized, and as a result, the Company recorded a valuation allowance for its deferred tax assets. The valuation allowance decreased by $2.7 million during the year ended December 31, 2017 and increased by $16.2 million during the year ended December 31, 2016. The difference between the income tax benefit and the amount computed by applying the federal statutory income tax rate to loss before income taxes is as follows (in thousands): Year Ended December 31, 2017 2016 Income tax benefit at federal statutory rate $ (3,746 ) $ (11,531 ) State taxes (net of federal) (8 ) (391 ) Credits (3,434 ) (4,932 ) Other 67 694 Change in valuation allowance (1,931 ) 16,160 Tax Rate Change 9,052 — Total $ — $ — On December 22, 2017, H.R.1, known as the “Tax Cuts and Jobs Act,” was signed into law. Among other things, the Tax Cuts and Jobs Act permanently lowers the corporate tax rate to 21% from the existing minimum rate of 35%, effective for tax years including or commencing January 1, 2018. As a result of this reduction of the corporate tax rate to 21% U.S. generally accepted accounting principles require companies to re-value The Company has revalued its deferred tax assets and liabilities as of December 31, 2017, at the new rate of 21% based upon balances in existence at date of enactment. Based upon preliminary estimates, it is currently expected that the Company’s net deferred tax assets before valuation allowance will be written down by approximately $9 million in the fourth quarter of 2017. This estimate is based upon a review and analysis of the Company’s net deferred tax assets. The Company’s actual write-down may vary materially from the estimated range due to a number of uncertainties and factors and is subject to further clarification of the new law that cannot be reasonably estimated at this time. As of December 31, 2017, the Company had federal net operating loss carryforwards of approximately $71.5 million and federal orphan drug credit carryforwards of approximately $23.9 million, which expire in the years 2019 through 2037. The Company also had California net operating loss carryforwards of approximately $44.1 million, which expire in the years 2028 through 2037, and California research and development tax credit carryforwards of approximately $9.9 million, which do not expire. Utilization of the Company’s NOL and credit carryforwards may be subject to additional annual limitations based on future stock issuances or ownership changes. Such future limitations could result in the expiration of the net operating loss and credit carryforwards before utilization. Based on the analyses performed on ownership changes that have occurred from inception through December 31, 2017, the Company expects to be able to use the NOL and tax credit carryforwards as noted above. The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. The Company is subject to U.S. federal and state income tax examinations by tax authorities for tax years from 1998 due to net operating losses and tax credits that are being carried forward for tax purposes. As of December 31, 2017, the Company does not believe that it is reasonably possible that its unrecognized benefits would significantly change in the following 12 months. The Company does not have any unrecognized tax benefits, or interest and penalties accrued on unrecognized tax benefits, at December 31, 2017, or during the two years then ended. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. |
Quarterly Results of Operations
Quarterly Results of Operations | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results of Operations | 14. Quarterly Results of Operations (unaudited) Following is a summary of the quarterly results of operations for the years ended December 31, 2017 and 2016 (in thousands, except per share data): March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Total revenue $ 1,693 $ 7,675 $ 2,728 $ 2,369 Operating expenses: Research and development 2,774 3,794 3,543 3,704 General and administrative 1,678 1,911 2,133 1,870 Restructuring and asset impairment — — — — Total expenses 4,452 5,705 5,676 5,574 Loss from operations (2,759 ) 1,970 (2,948 ) (3,205 ) Interest income (expense), net (925 ) (937 ) (947 ) (969 ) Other income (expense) 6 2 9 (2 ) Income (loss) before income taxes (3,678 ) 1,035 (3,886 ) (4,176 ) Income tax provision — — — — Income (net loss and comprehensive loss) $ (3,678 ) $ 1,035 $ (3,886 ) $ (4,176 ) Basic and diluted net income (loss) per common share $ (0.25 ) $ 0.07 $ (0.26 ) $ (0.28 ) Shares used in computing basic net income (loss) per common share 14,800 14,847 14,860 14,931 Shares used in computing diluted net income (loss) per common share 14,800 14,848 14,860 14,931 March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 Total revenues $ 6 $ 14 $ 50 $ 125 Operating expenses: Research and development 6,451 6,235 5,836 5,865 General and administrative 1,644 1,385 1,460 1,339 Restructuring and asset impairment 1 1 — — Total expenses 8,096 7,621 7,296 7,204 Loss from operations (8,090 ) (7,607 ) (7,246 ) (7,079 ) Interest income (expense), net 4 (551 ) (864 ) (913 ) Other income (expense) — (571 ) (76 ) 55 Loss before income taxes (8,086 ) (8,729 ) (8,186 ) (7,937 ) Income tax provision — — — — Net loss and comprehensive loss $ (8,086 ) $ (8,729 ) $ (8,186 ) $ (7,937 ) Basic and diluted net loss per common share $ (0.55 ) $ (0.59 ) $ (0.55 ) $ (0.54 ) Shares used in computing basic and diluted net loss per common share 14,761 14,778 14,782 14,795 |
Going Concern
Going Concern | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern | 15. Going Concern As reflected in the accompanying consolidated financial statements, the Company has an accumulated deficit of $455.2 million as of December 31, 2017 that includes a net loss of $10.7 million for the year ended December 31, 2017 which raises doubt about the Company’s ability to continue as a going concern. As of December 31, 2017, the Company’s current assets of $7.7 million exceed current liabilities of $5.5 million by $2.2 million. In February 2018, the Board of Directors (the “Board”) implemented temporary measures intended to preserve the Company’s cash resources until additional sources of capital can be identified, including the reduction of cash compensation and severance benefits for officers and the reduction of cash compensation for members of the Board. The Company believes that its cash and cash equivalents of approximately $7.1 million as of December 31, 2017 will only be sufficient to fund its operations through the first quarter of 2018. Therefore, the Company will continue to require additional capital through the issuance of debt or equity securities, royalty financing transactions, strategic transactions or otherwise, to fund the Company’s operations and continue the development of the Company’s lead product candidate Linhaliq. 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 balance sheet is dependent upon continued operations of the Company, the 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. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies Leases On April 1, 2017, the Company entered into an amendment of the current lease for a building containing offices, laboratory, and manufacturing facilities, through March 31, 2023. The lease calls for annual minimum rental payments that increase at the rate of 3.5% per annum throughout the lease term. In accordance with U.S. generally accepted accounting principles, the Company recognizes rent expense on a straight-line basis. The Company recorded deferred rent for the difference between the amounts paid and recorded as an expense. At December 31, 2017 and 2016, the Company had $32,000 and zero in deferred rent, respectively. The landlord has a one-time one-time one-time If the lease is not terminated early in accordance with its terms the Company’s future minimum rental payments required under the operating lease as of December 31, 2017, are as follows: For the year ended December 31, (in thousands) 2018 $ 482 2019 499 2020 516 2021 535 2022 553 Thereafter 140 Total $ 2,725 For the twelve months ended December 31, 2017 and 2016, base rental expense was approximately $492,000 and $587,000, respectively. Indemnification On May The Company from time to time enters into contracts that contingently require the Company to indemnify parties against third party claims. These contracts primarily relate to: (i) real estate leases, under which the Company may be required to indemnify property owners for environmental and other liabilities, and other claims arising from the Company’s use of the applicable premises, and (ii) agreements with the Company’s officers, directors and employees, under which the Company may be required to indemnify such persons from certain liabilities arising out of such persons’ relationships with the Company. To date, the Company has made no payments related to such indemnifications and no liabilities have been recorded for these obligations on the balance sheets at December 31, 2017 or 2016. Legal Matters On May 1, 2017, the Company filed a post grant review, or a PGR, petition in the United States Patent and Trademark Office Patent Trial and Appeal Board, or PTAB, challenging the validity of all 26 claims of U.S. Patent No.9,402,845 or the ‘845 Patent, assigned to Insmed Incorporated, or Insmed. The ‘845 Patent issued on August 2, 2016, and is entitled “Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof.” PGR is a proceeding that became available in September 2012 in accordance with the America Invents Act. In a PGR, a petitioner may request that PTAB reconsider the validity of issued patent claims. Any patent claim PTAB determines to be unpatentable is stricken from the challenged patent. In August 2017, Insmed filed a Preliminary Response. In November 2017, PTAB denied institution of our post-grant review of the ‘845 Patent. We are currently assessing the PTO’s decision. On January 11, 2018 a putative class action lawsuit, Kevin Kheder v. Aradigm Corporation, et al., No. 3:18-cv-00261, |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 17. Subsequent Events On February 9, 2018, the Board of Directors approved temporary measures intended to preserve the Company’s cash resources until additional sources of capital can be identified. These cash preservation measures include, among other things: • the termination of the Amended and Restated Aradigm Corporation Executive Officer Severance Benefit Plan, • the reduction of the annual base salary of certain executive officers to 50% of their then current annual base salaries, and • the reduction of cash compensation paid to members of the Board for services on the Board or committees of the Board to 50% of the then current cash compensation. Effective February 11, 2018, each of Igor Gonda, President and Chief Executive Officer; Juergen Froehlich, Chief Medical Officer; and Nancy Pecota, Vice President, Finance, Chief Financial Officer and Corporate Secretary resigned all offices and positions held by him or her with Aradigm. In addition, in February, 2018, Dr. Gonda and David Bell resigned from the Board of Directors. Dr. John Siebert, Chairman of the Board of Aradigm was appointed Executive Chairman and Interim Principal Executive Officer effective February 11, 2018. Additionally, on March 1, 2018, the Board appointed Dr. John Siebert as Acting Principal Financial Officer of the Company. Dr. Gonda and Dr. Juergen have been retained as consultants by the Company. |
Organization and Summary of S24
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | 1. Organization and Summary of Significant Accounting Policies 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 upcoming year. The Company operates as a single operating segment. |
Basis of Presentation and Consolidation | Basis of Presentation and Consolidation The accompanying 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. Certain prior period amounts have been conformed to the current period’s presentation. 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) Form 10-K reflect |
Liquidity and Financial Condition | Liquidity and Financial Condition The Company has incurred significant operating losses and negative cash flows from operations. At December 31, 2017, the Company had an accumulated deficit of approximately $455.2 million, working capital of approximately $2.2 million and shareholders’ deficit of approximately $12.5 million. Management expects operating losses to continue for the foreseeable future. As a result of expected losses and negative cash flows from operations, along with the Company’s cash position of $7.1 million at December 31, 2017, the Company will have sufficient resources to fund operations for the first quarter of 2018. The Company will need to raise additional capital through issuance of debt or equity securities, royalty financing transactions, strategic transactions or otherwise, to fund the Company’s operations and continue development of the Company’s lead product candidate Linhaliq in early 2018. No assurance can be given that the Company will be successful in raising such additional capital on favorable terms or at all. If the Company is unable to obtain additional funds when required, it will delay or reduce the scope of all or a portion of its development programs or dispose of assets or technology, and if not achieved on a timely basis would materially harm its business, financial condition and results of operations or require the Company to dispose of its assets or technology or to cease operations, and the Company may not be able to continue as a going concern. For more information, see “Note 15: Going Concern.” |
Use of Estimates | Use of Estimates The preparation of financial statements, in conformity with generally accepted accounting principles or 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, accruals for operating expenses, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. |
Cash Equivalents | 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 Consolidated Statement of Cash Flows based on the nature of the restriction. As of December 31, 2016, the Company had $1.0 million in restricted cash held in an interest-bearing escrow account for the purpose of making interest payments on the Convertible Notes, as outlined in Note 7 below. The Company was required to maintain such deposits sufficient to pay all required payments of interest through May 1, 2017. On December 31, 2017, the restricted cash balance is zero. |
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 include external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software include 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. The standard estimated useful lives of property and equipment are as follows: Computer equipment and software 3 years Furniture and fixtures 7 years Lab equipment 5 years Machinery and equipment 5 years Leasehold improvements 5 years |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews for impairment whenever events or changes in circumstances indicate that the carrying amount of property and equipment may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values, and the loss is recognized in the Consolidated Statements of Operations and Comprehensive Loss. |
Convertible Instruments | Convertible Instruments The Company accounts for hybrid contracts that feature conversion options in accordance with GAAP. ASC 815, Derivatives and Hedging Activities 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 has followed the provisions of ASC Topic 606, Revenue from Contracts with Customers 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 consideration. Non-refundable In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. 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. The Company’s performance obligations include license rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is 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 As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success. The Company allocates the total transaction price to each performance obligation 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 an income approach model and include the following key assumptions: the development timeline, revenue forecast, commercialization expenses, discount rate and probabilities of technical and regulatory success. To estimate selling prices for development services, regulatory submission services, and product supply, the Company uses a cost plus margin approach. Licenses of intellectual property: from non-refundable, up-front fees from non-refundable, up-front fees. The Milestone payments: Royalties: 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. Arrangements that include a promise for the future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, the material rights are accounted for as separate performance obligations. Payments associated with optional items are allocated to the performance obligations in the separate contract. If the Company is entitled to additional payments for performance obligations in the original arrangement when the customer exercises these options, any additional payments are allocated to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation and recorded in license, collaboration, and other revenues when the customer obtains control of the goods or services. |
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. 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 re-measured into 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 year ended December 31, 2017, the Company offset its research and development costs by approximately $1 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 ASC 505-50, 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 the 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 its income taxes in each of the jurisdictions in which it operates. This process involves the estimation of the 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 its 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, it will record a valuation allowance against the deferred tax assets that it estimates will not ultimately be recoverable. At December 31, 2017 and 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, it 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 shares subject to repurchase. Diluted net income/(loss) per common share is based on the weighted average number of common and common share equivalents, such as stock options and unvested restricted stock shares outstanding during the period. Potentially dilutive securities were not included in the net loss per common share calculation for the years ended December 31, 2017 and 2016 because the inclusion of such shares would have had an anti-dilutive effect. Refer to Note 11 for a summary of the anti-dilutive securities. |
Significant Concentrations | Significant Concentrations Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments. Risks associated with these instruments are mitigated by banking with, and only purchasing commercial paper and corporate notes from, creditworthy institutions. The maximum amount of loss due to credit risk associated with these financial instruments is their respective fair values as stated in the accompanying Consolidated Balance Sheets. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) ASC 220, Comprehensive Income non-owner available-for-sale |
Accounting Changes | Accounting Changes In May 2014, the Financial Accounting Standards Board or 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. See Note 8 for further details. In March 2016, the FASB issued Accounting Standards Update, or ASU 2016-09, Improvements to Employee Share-Based Payment Accounting |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) |
Organization and Summary of S25
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Standard Estimated Useful Lives of Property and Equipment | The standard estimated useful lives of property and equipment are as follows: Computer equipment and software 3 years Furniture and fixtures 7 years Lab equipment 5 years Machinery and equipment 5 years Leasehold improvements 5 years |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): December 31, 2017 2016 Machinery and equipment $ 4,382 $ 4,363 Furniture and fixtures 592 578 Lab equipment 1,449 1,446 Computer equipment and software 1,874 1,821 Leasehold improvements 1,799 1,734 Property and equipment 10,096 9,942 Less accumulated depreciation and amortization (9,807 ) (9,689 ) Property and equipment, net $ 289 $ 253 |
Sublease Agreement and Lease 27
Sublease Agreement and Lease Exit Liability (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Lease Exit Liability Activity | The lease exit liability activity for the years ended December 31, 2017 and 2016 is as follows (in thousands): Year Ended December 31, 2017 2016 Balance at the beginning of year $ — $ 104 Accretion expense — 2 Lease payments — (106 ) Balance at the end of the year $ — $ — |
Convertible Notes and Warrants
Convertible Notes and Warrants (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Summary of activity in Derivative Liability and Warrant Liability | The following table summarizes the activity in the derivative liability and the warrant liability for the year ended December 31, 2016: Year Ended December 31, 2016 Fair Value Fair Value of Change Reclassifications to Equity Fair Value 2016 Derivative liability $ — $ 8,748 $ (386 ) $ (8,362 ) $ — Warrant liability — 11 — (11 ) — Total $ — $ 8,759 $ (386 ) $ (8,373 ) $ — |
Summary of Convertible Notes | As of December 31, 2017 and 2016, the Convertible Notes consisted of the following: December 31, 2017 December 31, 2016 (in thousands, except conversion rate and conversion price) Principal value $ 23,000 $ 23,000 Unamortized debt discount (6,948 ) (8,501 ) Unamortized debt issuance costs (1,044 ) (1,280 ) Carrying value of the convertible notes $ 15,008 $ 13,219 Conversion rate (shares of common stock per $1,000 principal amount of notes) 191.9386 191.9386 Conversion price (per share of common stock) $ 5.21 $ 5.21 |
Summary of Interest Expense Associated with Convertible Notes | For the years ended December 31, 2017 and 2016, the Company recognized interest expense associated with its Convertible Notes as follows: Year ended December 31, 2017 Year ended December 31, 2016 (in thousands) Cash Interest Expense Coupon interest expense $ 2,070 $ 1,349 Other interest expense 12 — Noncash Interest Expense Amortization of debt discount 1,552 920 Amortization of transaction costs 236 137 $ 3,870 $ 2,406 |
Initial Closing [Member] | |
Schedule of Fair Value Assumption Used to Measure Derivative and Warrant Liability | The following assumptions were used in the Black-Scholes Model to measure the fair value of the derivative and warrant liability as of June 9, 2016 (the date of the shareholder vote) and April 21, 2016 (the date of the first closing): June 9, 2016 April 21, 2016 Fair value of underlying stock—per share $ 4.48 $ 4.55 Risk-free interest rate 1.20 % 1.35 % Expected life (years) 4.9 5 Expected volatility 73.16 % 73.95 % Dividend yield 0.0 % 0.0 % |
Second and Final Closing [Member] | |
Schedule of Fair Value Assumption Used to Measure Derivative and Warrant Liability | The following assumptions were used in the Black-Scholes Model to measure the fair value of the Warrants as of July 14, 2016: July 14, 2016 Fair value of underlying stock—per share $ 4.58 Risk-free interest rate 1.07 % Expected life (years) 4.78 Expected volatility 72.87 % Dividend yield 0.0 % |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Reconciliation of Contract Liabilities | The following table shows the reconciliation of Contract Liabilities from what was disclosed in the Form 10-K Deferred Revenue, balance at December 31, 2016 $ 5,000 Changes in estimated consideration — Unsatisfied performance obligations 6,026 Deferred Revenue, balance at January 1, 2017 $ 11,026 |
Summary of Changes in Contract Assets and Liabilities | The following table presents changes in the Company’s contract assets and liabilities for the year ended December 31, 2017. Balance at of the Year Additions Deductions Balance at the end of the Year (in thousands) Contract Assets $ — $ 67 $ — $ 67 Contract Liabilities: Deferred Revenue $ 11,026 $ 5,411 $ (14,264 ) $ 2,173 |
Summary of Revenue Recognized | During the year ended December 31, 2017, the Company recognized the following revenues (in thousands). Revenue recognized in the period from: Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied $ 9,167 New activities in the period: Changes in the estimated transaction price allocated to performance obligations satisfied in prior periods 4,527 Performance obligations satisfied from new activities in the current period—contract revenue 649 Performance obligations satisfied from new activities in the current period—grant revenue 122 Total revenue $ 14,465 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Schedule of Activity Under Stock Option Plan | The following is a summary of activity (time- and performance-based) under the 2005 Plan and the 2015 Plan for the year ended December 31, 2017: Shares Available for Balance at January 1, 2017 1,510,272 Increase in authorized shares 2,500,000 Options granted (2,041,901 ) Options cancelled 215,853 Restricted stock awards granted (539,100 ) Balance at December 31, 2017 1,645,124 Stock Options Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at January 1, 2017 1,923,595 $ 6.86 Options granted 2,041,901 $ 3.29 Options exercised (22,062 ) $ 2.12 Options cancelled (215,853 ) $ 10.53 Outstanding at December 31, 2017 3,727,581 $ 4.72 8.27 $ 8,763,440 Ending exercisable 1,634,831 $ 4.76 7.30 $ 3,909,557 |
Schedule of Stock-Based Compensation Expense | The following table shows stock-based compensation expense included in the Consolidated Statement of Operations and Comprehensive loss for the years ended December 31, 2017 and 2016, (in thousands, except per share amounts): 2017 2016 Costs and Expenses Research and development $ 1,317 $ 826 General and administrative 1,301 850 Total stock-based compensation expense $ 2,618 $ 1,676 Impact on basic and diluted net loss per common share $ (0.18 ) $ (0.11 ) |
Employee Options [Member] | |
Schedule of Stock Based Compensation Valuation Assumption | The weighted average assumptions for employee stock purchase rights under the ESPP were as follows: Years Ended December 31, 2017 2016 Dividend yield 0.0 % N/A Volatility factor 81.7 % N/A Risk-free interest rate 1.2 % N/A Expected life (years) 2.0 N/A Weighted-average fair value of purchase rights granted during the period $ 0.90 N/A |
Restricted Stock Awards [Member] | |
Schedule of Unvested Restricted Stock and Performance Bonus Stock Awards | A summary of the activity of the Company’s unvested restricted stock and performance-based restricted stock award activities for the year ended December 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 Average Grant Date Fair Value Outstanding at January 1, 2017 152,238 $ 3.96 Restricted stock awards granted 539,100 1.39 Restricted stock awards vested (77,800 ) 2.03 Outstanding at December 31, 2017 613,538 $ 1.95 |
Unvested Restricted Stock Units [Member] | |
Schedule of Unvested Restricted Stock and Performance Bonus Stock Awards | Restricted Stock Units Number of Shares Weighted Average Grant Date Fair Value Outstanding at January 1, 2017 10,306 $ 5.34 Restricted stock units granted — — Restricted stock units vested — — Outstanding at December 31, 2017 10,306 $ 5.34 |
Service Based Option [Member] | |
Schedule of Stock Based Compensation Valuation Assumption | The weighted average assumptions for employee service-based options (which for purposes of this table includes members of the board of directors) were as follows: Years Ended December 31 2017 2016 Dividend yield 0.0 % 0.0 % Volatility factor 81.1 % 74.0 % Risk-free interest rate 2.0 % 1.4 % Expected term (in years) 5.6 5.5 Weighted-average fair value of options granted during the periods $ 2.24 $ 3.13 |
Performance-Based Options [Member] | |
Schedule of Stock Based Compensation Valuation Assumption | The weighted average assumptions for performance-based options were as follows: Years Ended December 31, 2017 2016 Dividend yield 0.0 % 0.0 % Volatility factor 80.4 % 77.1 % Risk-free interest rate 2.1 % 1.5 % Expected term (in years) 5.2 5.7 Weighted-average fair value of options granted during the period $ 2.64 $ 2.68 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 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 years ended December 31, 2017 and 2016, as their effect would be anti-dilutive (in thousands): Year ended December 31, 2017 2016 Common shares underlying convertible notes 4,415 4,415 Outstanding stock options 3,728 1,924 Common shares underlying warrants 263 263 Unvested restricted stock 613 152 Unvested restricted stock units 10 10 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Summary of Income (Loss) Before Provision for Income Taxes | Income (loss) before provision for income taxes consists as follows (in thousands) December 31, 2017 2016 United Sates $ (11,465 ) $ (31,594 ) International 760 (1,344 ) Total $ (10,705 ) $ (32,938 ) |
Significant Components of Company's Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities were as follows (in thousands): December 31, 2017 2016 Net operating loss carryforwards $ 18,267 $ 25,536 Research and development credits 7,898 6,509 Federal orphan drug credits 23,881 18,599 Other 1,483 3,572 Total deferred tax assets 51,529 54,216 Valuation allowance (51,529 ) (54,216 ) Net deferred tax assets $ — $ — |
Schedule of Difference Between Income Tax Benefit and Computation Amount of Federal Statutory Income Tax Rate | The difference between the income tax benefit and the amount computed by applying the federal statutory income tax rate to loss before income taxes is as follows (in thousands): Year Ended December 31, 2017 2016 Income tax benefit at federal statutory rate $ (3,746 ) $ (11,531 ) State taxes (net of federal) (8 ) (391 ) Credits (3,434 ) (4,932 ) Other 67 694 Change in valuation allowance (1,931 ) 16,160 Tax Rate Change 9,052 — Total $ — $ — |
Quarterly Results of Operatio33
Quarterly Results of Operations (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Quarterly Results of Operations | Following is a summary of the quarterly results of operations for the years ended December 31, 2017 and 2016 (in thousands, except per share data): March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Total revenue $ 1,693 $ 7,675 $ 2,728 $ 2,369 Operating expenses: Research and development 2,774 3,794 3,543 3,704 General and administrative 1,678 1,911 2,133 1,870 Restructuring and asset impairment — — — — Total expenses 4,452 5,705 5,676 5,574 Loss from operations (2,759 ) 1,970 (2,948 ) (3,205 ) Interest income (expense), net (925 ) (937 ) (947 ) (969 ) Other income (expense) 6 2 9 (2 ) Income (loss) before income taxes (3,678 ) 1,035 (3,886 ) (4,176 ) Income tax provision — — — — Income (net loss and comprehensive loss) $ (3,678 ) $ 1,035 $ (3,886 ) $ (4,176 ) Basic and diluted net income (loss) per common share $ (0.25 ) $ 0.07 $ (0.26 ) $ (0.28 ) Shares used in computing basic net income (loss) per common share 14,800 14,847 14,860 14,931 Shares used in computing diluted net income (loss) per common share 14,800 14,848 14,860 14,931 March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 Total revenues $ 6 $ 14 $ 50 $ 125 Operating expenses: Research and development 6,451 6,235 5,836 5,865 General and administrative 1,644 1,385 1,460 1,339 Restructuring and asset impairment 1 1 — — Total expenses 8,096 7,621 7,296 7,204 Loss from operations (8,090 ) (7,607 ) (7,246 ) (7,079 ) Interest income (expense), net 4 (551 ) (864 ) (913 ) Other income (expense) — (571 ) (76 ) 55 Loss before income taxes (8,086 ) (8,729 ) (8,186 ) (7,937 ) Income tax provision — — — — Net loss and comprehensive loss $ (8,086 ) $ (8,729 ) $ (8,186 ) $ (7,937 ) Basic and diluted net loss per common share $ (0.55 ) $ (0.59 ) $ (0.55 ) $ (0.54 ) Shares used in computing basic and diluted net loss per common share 14,761 14,778 14,782 14,795 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Rental Payments Required under the Operating Lease | If the lease is not terminated early in accordance with its terms the Company’s future minimum rental payments required under the operating lease as of December 31, 2017, are as follows: For the year ended December 31, (in thousands) 2018 $ 482 2019 499 2020 516 2021 535 2022 553 Thereafter 140 Total $ 2,725 |
Organization and Summary of S35
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2017USD ($)Segment | Dec. 31, 2017AUD ($)Segment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Income Tax Expense Benefit [Line Items] | ||||
Number of operating segment | Segment | 1 | 1 | ||
Accumulated deficit | $ (455,170,000) | $ (438,419,000) | ||
Working capital | 2,200,000 | |||
Shareholders' deficit | (12,531,000) | 987,000 | $ 23,110,000 | |
Cash position | 7,095,000 | 22,591,000 | $ 31,462,000 | |
Restricted cash | 0 | 1,006,000 | ||
Restricted cash held in interest bearing escrow account | $ 1,000,000 | |||
Amount of research and development cost offset through the recognition of tax incentive credits | 1,000,000 | |||
Accounting Standards Update 2016-09 [Member] | ||||
Income Tax Expense Benefit [Line Items] | ||||
Cumulative effect on retained earning net of tax due to accounting changes | $ 21,000 | |||
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 | $ 20,000,000 |
Organization and Summary of S36
Organization and Summary of Significant Accounting Policies - Summary of Standard Estimated Useful Lives of Property and Equipment (Detail) | 12 Months Ended |
Dec. 31, 2017 | |
Computer Equipment and Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 3 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 7 years |
Lab Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Machinery and Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 10,096 | $ 9,942 |
Less accumulated depreciation and amortization | (9,807) | (9,689) |
Property and equipment, net | 289 | 253 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 4,382 | 4,363 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 592 | 578 |
Lab Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 1,449 | 1,446 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 1,874 | 1,821 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,799 | $ 1,734 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 118 | $ 121 |
Asset retired | $ 2,700 |
Sublease Agreement and Lease 39
Sublease Agreement and Lease Exit Liability - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2017USD ($) | Dec. 31, 2007USD ($) | Dec. 31, 2016USD ($) | Jul. 18, 2007ft² | |
Lease Rental Expenses [Line Items] | ||||
Lease agreement initiation date | Jul. 18, 2007 | |||
Sublease agreement, number of square feet | ft² | 72,000 | |||
Impairment expense related to the sublease | $ | $ 2,100,000 | |||
Lease liability | $ | $ 0 | $ 0 | ||
Mendel [Member] | ||||
Lease Rental Expenses [Line Items] | ||||
Sublease agreement, number of square feet | ft² | 48,000 |
Sublease Agreement and Lease 40
Sublease Agreement and Lease Exit Liability - Schedule of Lease Exit Liability Activity (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Leases [Abstract] | |
Balance at the beginning of year | $ 104 |
Accretion expense | 2 |
Lease payments | $ (106) |
Other Accrued Liabilities - Add
Other Accrued Liabilities - Additional Information (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Other Accrued Liabilities [Line Items] | ||
Accrued payroll withholding liabilities | $ 1,643,000 | $ 1,335,000 |
Other Accrued Liabilities [Member] | ||
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for services | 132,000 | 105,000 |
Accrued payroll withholding liabilities | 86,000 | 51,000 |
Convertible Debt [Member] | Other Accrued Liabilities [Member] | ||
Other Accrued Liabilities [Line Items] | ||
Accrued expenses for interest | $ 345,000 | $ 340,000 |
Convertible Notes and Warrant42
Convertible Notes and Warrants - Additional Information (Detail) | Dec. 01, 2017$ / shares | Jul. 14, 2016USD ($)Investorshares | Jun. 09, 2016USD ($) | Apr. 25, 2016USD ($)Investorshares | Apr. 21, 2016USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares |
Debt Instrument [Line Items] | |||||||
Aggregate principal amount | $ 23,000,000 | $ 23,000,000 | |||||
Debt conversion, initial conversion ratio, numerator | shares | 191.9386 | 191.9386 | |||||
Debt conversion, initial conversion ratio, denominator | $ 1,000 | $ 1,000 | |||||
Debt conversion, initial conversion price per share | $ / shares | $ 5.21 | $ 5.21 | |||||
Purchasable portion of notes equal to percentage of principal amount of notes | 100.00% | ||||||
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% | ||||||
Proceeds from issuance of convertible debt | $ 3,050,000 | ||||||
Proceeds from related party convertible debt | 19,950,000 | ||||||
Fair value of the warrants issued | 662,000 | ||||||
Amortization of financing cost | $ 236,000 | 137,000 | |||||
Financing costs, derivative liability and warrant | 997,000 | ||||||
Gain recognized on derivative and warrant liabilities | (386,000) | ||||||
Reclassifications to equity | 8,373,000 | ||||||
Other miscellaneous interest expense | 12,000 | ||||||
Debt instrument, If-converted value exceeds principal balance | $ 6,600,000 | ||||||
Derivative Liability [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gain recognized on derivative and warrant liabilities | (386,000) | ||||||
Reclassifications to equity | $ 8,400,000 | 8,362,000 | |||||
Derivative Liability [Member] | Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gain recognized on derivative and warrant liabilities | 386,000 | ||||||
Warrants Liability [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Reclassifications to equity | 11,000 | ||||||
Warrants Liability [Member] | Fair Value, Inputs, Level 3 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Gain recognized on derivative and warrant liabilities | 500 | ||||||
Minimum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Redeemable portion of notes equal to or greater than percentage of sale price of common stock | 200.00% | ||||||
Class of Warrant Issued April 22, 2016 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Warrants term | 5 years | ||||||
Warrants, exercise price | $ / shares | $ 5.21 | ||||||
Warrants, exercisable commencing date | Oct. 25, 2016 | ||||||
Warrants exercisable, description | The Warrants are exercisable commencing on the later of October 25, 2016, and the date of the public release of top-line data related to the conclusion of the ORBIT-3 and ORBIT-4 Phase 3 pivotal clinical trials for the Company’s investigational product Linhaliq inhaled ciprofloxacin. If, at any time from and after October 25, 2016, the daily volume-weighted average price of the shares of the Company’s common stock for each of ten consecutive trading days exceeds 150% of the Exercise Price, the Company will have the right to call all or a portion of the Warrants for redemption upon twenty business days prior notice to the holders, at a redemption price of $0.01 per Warrant; provided that the holders of the Warrants may elect to exercise their Warrants upon receipt of any redemption notice from the Company. | ||||||
Warrants redemption Price | $ / shares | $ 0.01 | ||||||
Convertible Debt [Member] | Senior Convertible Notes Due 2021 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Financing cost | $ 2,400,000 | ||||||
Amortization of financing cost | $ 1,400,000 | ||||||
Unamortized debt discount remaining amortization period | 3 years 4 months 2 days | ||||||
Convertible Debt [Member] | Senior Convertible Notes Due 2021 [Member] | Minimum [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 Debt [Member] | Other Accrued Liabilities [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Accrued interest payable | $ 345,000 | 340,000 | |||||
Convertible Debt [Member] | Other Accrued Liabilities [Member] | Senior Convertible Notes Due 2021 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Accrued interest payable | $ 345,000 | $ 340,000 | |||||
Second and Final Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Amount funded by number of investors | Investor | 2 | ||||||
Escrow deposit | $ 215,000 | ||||||
Second and Final Closing [Member] | Class of Warrant Issued April 22, 2016 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Class of warrants or rights, issued | shares | 259,117 | ||||||
Fair value of the warrants issued | $ 662,000 | ||||||
Second and Final Closing [Member] | Convertible Debt [Member] | Senior Convertible Notes Due 2021 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of convertible debt | $ 3,000,000 | ||||||
Effective interest rate on liability component | 16.24% | ||||||
Initial Closing [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Amount funded by number of investors | Investor | 2 | ||||||
Initial Closing [Member] | Class of Warrant Issued April 22, 2016 [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Amount funded by number of investors | Investor | 1 | ||||||
Class of warrants or rights, issued | shares | 4,319 | ||||||
Initial Closing [Member] | Convertible Debt [Member] | Senior Convertible Notes Due 2021 [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% | ||||||
Escrow deposit | $ 1,800,000 | ||||||
Initial Closing [Member] | Convertible Debt [Member] | Senior Convertible Notes Due 2021 [Member] | Grifols [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] | |||||||
Debt Instrument [Line Items] | |||||||
Debt conversion, initial conversion ratio, numerator | shares | 191.9386 | ||||||
Debt conversion, initial conversion ratio, denominator | $ 1,000 | ||||||
Debt conversion, initial conversion price per share | $ / shares | $ 5.21 | ||||||
Debt conversion, initial conversion ratio | 0.191939 | ||||||
Debt conversion, description | The Convertible Notes are initially convertible into the Company’s common stock at a conversion rate of 191.9386 shares of common stock per $1,000 principal amount of Convertible Notes, representing an initial effective conversion price of $5.21 per share of common stock | ||||||
Private Placement [Member] | Convertible Debt [Member] | Senior Convertible Notes Due 2021 [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. |
Convertible Notes and Warrant43
Convertible Notes and Warrants - Schedule of Fair Value Assumption Used to Measure Derivative and Warrant Liability (Detail) - $ / shares | Jul. 14, 2016 | Jun. 09, 2016 | Apr. 21, 2016 |
Initial Closing [Member] | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Fair value of underlying stock - per share | $ 4.48 | $ 4.55 | |
Risk-free interest rate | 1.20% | 1.35% | |
Expected life (years) | 4 years 10 months 25 days | 5 years | |
Expected volatility | 73.16% | 73.95% | |
Dividend yield | 0.00% | 0.00% | |
Second and Final Closing [Member] | |||
Fair Value Measurements, Recurring and Nonrecurring, Valuation Techniques [Line Items] | |||
Fair value of underlying stock - per share | $ 4.58 | ||
Risk-free interest rate | 1.07% | ||
Expected life (years) | 4 years 9 months 11 days | ||
Expected volatility | 72.87% | ||
Dividend yield | 0.00% |
Convertible Notes and Warrant44
Convertible Notes and Warrants - Summary of Activity in Derivative Liability and Warrant Liability (Detail) - USD ($) $ in Thousands | Jun. 09, 2016 | Dec. 31, 2016 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 0 | |
Fair Value of Instruments Issued | 8,759 | |
Change in Fair value | (386) | |
Reclassifications to Equity | (8,373) | |
Ending balance | 0 | |
Derivative Liability [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 0 | |
Fair Value of Instruments Issued | 8,748 | |
Change in Fair value | (386) | |
Reclassifications to Equity | $ (8,400) | (8,362) |
Ending balance | 0 | |
Warrants Liability [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 0 | |
Fair Value of Instruments Issued | 11 | |
Reclassifications to Equity | (11) | |
Ending balance | $ 0 |
Convertible Notes and Warrant45
Convertible Notes and Warrants - Summary of Convertible Notes (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Convertible Debt [Abstract] | ||
Principal value | $ 23,000 | $ 23,000 |
Unamortized debt discount | (6,948) | (8,501) |
Unamortized debt issuance costs | (1,044) | (1,280) |
Carrying value of the convertible notes | $ 15,008 | $ 13,219 |
Conversion rate (shares of common stock per $1,000 principal amount of notes) | 191.9386 | 191.9386 |
Conversion price (per share of common stock) | $ 5.21 | $ 5.21 |
Convertible Notes and Warrant46
Convertible Notes and Warrants - Summary of Convertible Notes (Parenthetical) (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Convertible Debt [Abstract] | ||
Debt conversion, initial conversion ratio, denominator | $ 1,000 | $ 1,000 |
Convertible Notes and Warrant47
Convertible Notes and Warrants - Summary of Interest Expense Associated with Convertible Notes (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Interest Expense [Abstract] | ||
Coupon interest expense | $ 2,070 | $ 1,349 |
Other interest expense | 12 | |
Noncash Interest Expense | ||
Amortization of debt discount | 1,552 | 920 |
Amortization of transaction costs | 236 | 137 |
Interest expense | $ 3,870 | $ 2,406 |
Revenue Recognition - Additiona
Revenue Recognition - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue Recognition [Line Items] | ||
Royalty revenue | $ 0 | |
Accounting Standards Update 2014-09 [Member] | ||
Revenue Recognition [Line Items] | ||
Increase in accumulated deficit | $ 6,000,000 | |
Increase in deferred revenue | $ 6,000,000 | |
Increase in revenue for services performed | 9,400,000 | |
Decrease in net loss | $ 13,900,000 | |
Decrease in basic net loss per share | $ 0.94 | |
Decrease in diluted net loss per share | $ 0.94 | |
Accounting Standards Update 2014-09 [Member] | Research and Development [Member] | ||
Revenue Recognition [Line Items] | ||
Increase in revenue for services performed | $ 4,500,000 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Reconciliation of Contract Liabilities (Detail) - USD ($) $ in Thousands | Jan. 01, 2017 | Dec. 31, 2017 |
Deferred Revenue Disclosure [Abstract] | ||
Deferred Revenue, beginning balance | $ 5,000 | $ 5,000 |
Changes in estimated consideration | 0 | |
Unsatisfied performance obligations | 6,026 | $ 5,411 |
Deferred Revenue, ending balance | $ 11,026 |
Revenue Recognition - Summary o
Revenue Recognition - Summary of Changes in Contract Assets and Liabilities (Detail) - USD ($) $ in Thousands | Jan. 01, 2017 | Dec. 31, 2017 |
Revenue Recognition and Deferred Revenue [Abstract] | ||
Contract assets, additions | $ 67 | |
Contract assets, deductions | 0 | |
Contract Assets, ending balance | 67 | |
Contract liabilities: deferred revenue, beginning balance | $ 11,026 | 11,026 |
Contract liabilities: deferred revenue, additions | $ 6,026 | 5,411 |
Contract liabilities: deferred revenue, deductions | (14,264) | |
Contract liabilities: deferred revenue, ending balance | $ 2,173 |
Revenue Recognition - Summary51
Revenue Recognition - Summary of Revenue Recognized (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Jun. 30, 2017 | Dec. 31, 2017 | |
Revenue recognized in the period from: | ||
Performance obligations satisfied | $ 4,500 | $ 9,167 |
New activities in the period: | ||
Changes in the estimated transaction price allocated to performance obligations satisfied in prior periods | 4,527 | |
Total revenue | 14,465 | |
Contract Revenue [Member] | ||
New activities in the period: | ||
Performance obligations satisfied from new activities in the current period | 649 | |
Grant Revenue [Member] | ||
New activities in the period: | ||
Performance obligations satisfied from new activities in the current period | $ 122 |
Collaboration Agreement - Gover
Collaboration Agreement - Governance Agreement - Additional Information (Detail) | Jan. 01, 2017USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($)Person | Dec. 31, 2016USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Reimbursable research and development expenses by partner | $ 65,000,000 | |||
Milestone payment to be earned | 5,000,000 | |||
Contract revenue recognized | $ 6,026,000 | $ 5,411,000 | ||
Additional deferred revenue | 14,264,000 | |||
Milestone payments received | 10,000,000 | |||
Performance obligation satisfied | $ 4,500,000 | 9,167,000 | ||
Unsatisfied performance obligations | 11,026,000 | 5,000,000 | ||
Maximum [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Payments receivable upon the achievement of regulatory filing and approval milestones | 25,000,000 | |||
Grifols [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Milestone payment to be earned | $ 5,000,000 | |||
Unsatisfied performance obligations | 2,000,000 | |||
Grifols [Member] | ASC 606 [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Contract revenue recognized | $ 6,000,000 | |||
Additional deferred revenue | 14,000,000 | |||
Milestone payments received | 5,000,000 | |||
License Agreement with Grifols [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Reimbursable research and development expenses by partner | 65,000,000 | |||
Payments for development milestones by partner | $ 25,000,000 | |||
Patent coverage or orphan drug designation period | 10 years | |||
Percentage of reduction on royalty payment | 50.00% | |||
Fully utilized reimbursable research and development expenses | $ 65,000,000 | |||
License Agreement with Grifols [Member] | Minimum [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Royalty payments on net sales rate | 12.50% | |||
License Agreement with Grifols [Member] | Maximum [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Royalty payments on net sales rate | 20.00% | |||
Grifols Governance Agreement [Member] | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Number of independent directors | Person | 3 | |||
Number of directors designated by partner | Person | 2 | |||
Number of chief executive officer | Person | 1 | |||
Period to be consider after the first commercial sale for restriction to acquire and sale of stock | 12 months | |||
Minimum target percentage of beneficial ownership to be maintain under governance agreement | 43.30% | 35.00% |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) | Jan. 01, 2018 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Stock [Line Items] | |||||
Number of right for each share of common stock outstanding | 1 | ||||
Rights expiration date | Sep. 8, 2018 | ||||
Incentive and non-statutory stock option grants option price | 110.00% | ||||
Intrinsic value of stock options exercised | $ 69,000 | $ 0 | |||
Compensation expense | 2,618,000 | 1,676,000 | |||
Limitation of Employee contributions, through payroll deductions to lessor | 18,000 | ||||
Capitalized stock-based employee compensation cost | 0 | 0 | |||
Tax benefit associated with stock-based compensation expense | $ 0 | 0 | |||
Expected term of options granted | 2 years | ||||
Expected dividend yield | 0.00% | ||||
Employee stock purchase rights value | $ 103,000 | 104,000 | |||
Restricted Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Total fair value of restricted stock awards vested | $ 213,000 | 53,000 | |||
Stock Options [Member] | |||||
Class of Stock [Line Items] | |||||
Incentive and non-statutory stock option grants option price | 85.00% | ||||
Shares acquired vest period | 4 years | ||||
Compensation expense | $ 105,000 | 73,000 | |||
Number of days employees have to continuously employed to participate in the Employee Stock Purchase Plan | 10 days | ||||
Customary employment weekly period required to participate in the ESPP | 20 hours | ||||
Minimum period employee required to work per calendar year to participate in ESPP | 5 months | ||||
Condition given to employees to participate in ESPP | 5.00% | ||||
Percentage of limitation of Employee contributions, through payroll deductions to lessor | 15.00% | ||||
Number of shares of common stock authorized | 486,250 | ||||
Number of Shares issued under the ESPP | 274,644 | ||||
Number of shares of common stock authorized remaining | 211,606 | ||||
Unrecognized compensation expense | $ 184,000 | ||||
Employee stock purchase rights value | $ 0 | ||||
Expected term offering period | 2 years | ||||
Unvested Restricted Stock Units [Member] | |||||
Class of Stock [Line Items] | |||||
Total fair value of restricted stock awards vested | $ 0 | $ 0 | |||
Unvested Stock Options and Stock Purchases [Member] | |||||
Class of Stock [Line Items] | |||||
Options granted expiration | 1 year 3 months 19 days | ||||
Unrecognized compensation cost related to stock options and stock purchases | $ 3,049,000 | ||||
Performance-Based Options [Member] | |||||
Class of Stock [Line Items] | |||||
Compensation expense | $ 0 | $ 0 | |||
Performance-based stock options, cancelled | 170,000 | ||||
Expected dividend yield | 0.00% | 0.00% | |||
Performance-Based Options [Member] | Subsequent Event [Member] | |||||
Class of Stock [Line Items] | |||||
Performance-based stock options, cancelled | 440,000 | ||||
Non Vested Restricted Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Options granted expiration | 3 months 19 days | ||||
Unrecognized compensation expense | $ 249,000 | ||||
Executive Officer [Member] | Performance-Based Options [Member] | |||||
Class of Stock [Line Items] | |||||
Performance-based stock options, granted | 460,000 | 595,000 | |||
Performance-based stock options, weighted average exercise price | $ 4.02 | $ 4.09 | |||
Compensation expense | $ 0 | ||||
Performance-based restricted stock awards, granted | 421,000 | ||||
Performance-based restricted stock awards, weighted average fair value | $ 1.39 | ||||
Officers and Vice President [Member] | Performance-Based Options [Member] | Subsequent Event [Member] | |||||
Class of Stock [Line Items] | |||||
Performance-based stock options, cancelled | 395,000 | ||||
2005 and 2015 Plan [Member] | |||||
Class of Stock [Line Items] | |||||
Options granted expiration | 10 years | ||||
Incentive and non-statutory stock option grants option price | 100.00% | ||||
Non-statutory stock option grants option price | 85.00% | ||||
Combined voting power | 10.00% | ||||
Shares acquired vest period | 5 years | ||||
Outstanding notes receivables | $ 0 | $ 0 | |||
Number of shares repurchased | 0 | ||||
2005 and 2015 Plan [Member] | Unvested Restricted Stock Units [Member] | |||||
Class of Stock [Line Items] | |||||
Unrecognized compensation cost related to stock options and stock purchases | $ 0 | ||||
2005 [Member] | |||||
Class of Stock [Line Items] | |||||
Plan expiration date | 2015-03 | ||||
Increasing in shares of common stock authorized for issuance | 2,500,000 | 2,400,000 | |||
Maximum [Member] | Stock Options [Member] | |||||
Class of Stock [Line Items] | |||||
Limitation of Employee contributions, through payroll deductions to lessor | $ 25,000 |
Shareholders' Equity - Schedule
Shareholders' Equity - Schedule of Activity Under Stock Option Plan - Shares Available for Future Grant (Detail) | 12 Months Ended |
Dec. 31, 2017shares | |
Stock Options [Member] | |
Shares Available for Future Grant | |
Balance at January 1, 2017 | 1,510,272 |
Increase in authorized shares | 2,500,000 |
Options granted | (2,041,901) |
Options cancelled | 215,853 |
Balance at December 31, 2017 | 1,645,124 |
Restricted Stock Awards [Member] | |
Shares Available for Future Grant | |
Restricted stock awards granted | (539,100) |
Shareholders' Equity - Schedu55
Shareholders' Equity - Schedule of Activity Under Stock Option Plan - Options Outstanding (Detail) | 12 Months Ended |
Dec. 31, 2017USD ($)$ / sharesshares | |
Number of Shares | |
Options exercised | $ | $ (47,000) |
Weighted Average Remaining Contractual Term | |
Outstanding at December 31, 2017 | 2 years |
Stock Options [Member] | |
Number of Shares | |
Outstanding at January 1, 2017 | shares | 1,923,595 |
Options granted | shares | 2,041,901 |
Options exercised | $ | $ (22,062) |
Options cancelled | shares | (215,853) |
Outstanding at December 31, 2017 | shares | 3,727,581 |
Ending exercisable | shares | 1,634,831 |
Weighted Average Exercise Price | |
Outstanding at January 1, 2017 | $ 6.86 |
Options granted | 3.29 |
Options exercised | 2.12 |
Options cancelled | 10.53 |
Outstanding at December 31, 2017 | 4.72 |
Ending exercisable | $ 4.76 |
Weighted Average Remaining Contractual Term | |
Outstanding at December 31, 2017 | 8 years 3 months 8 days |
Ending exercisable | 7 years 3 months 19 days |
Aggregate Intrinsic Value | |
Outstanding at December 31, 2017 | $ | $ 8,763,440 |
Ending exercisable | $ | $ 3,909,557 |
Shareholders' Equity - Schedu56
Shareholders' Equity - Schedule of Unvested Restricted Stock and Performance Bonus Stock Awards (Detail) | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Unvested Restricted Stock Units [Member] | |
Number of Shares | |
Outstanding at January 1, 2017 | shares | 10,306 |
Outstanding at December 31, 2017 | shares | 10,306 |
Weighted Average Grant Date Fair Value | |
Outstanding at January 1, 2017 | $ / shares | $ 5.34 |
Outstanding at December 31, 2017 | $ / shares | $ 5.34 |
Restricted Stock Awards [Member] | |
Number of Shares | |
Outstanding at January 1, 2017 | shares | 152,238 |
Number of Shares, granted | shares | 539,100 |
Number of Shares, vested | shares | (77,800) |
Outstanding at December 31, 2017 | shares | 613,538 |
Weighted Average Grant Date Fair Value | |
Outstanding at January 1, 2017 | $ / shares | $ 3.96 |
Weighted Average Grant Date Fair Value, granted | $ / shares | 1.39 |
Weighted Average Grant Date Fair Value, vested | $ / shares | 2.03 |
Outstanding at December 31, 2017 | $ / shares | $ 1.95 |
Shareholders' Equity - Schedu57
Shareholders' Equity - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Costs and Expenses | ||
Total stock-based compensation expense | $ 2,618 | $ 1,676 |
Impact on basic and diluted net loss per common share | $ (0.18) | $ (0.11) |
Research and Development [Member] | ||
Costs and Expenses | ||
Total stock-based compensation expense | $ 1,317 | $ 826 |
General and Administrative [Member] | ||
Costs and Expenses | ||
Total stock-based compensation expense | $ 1,301 | $ 850 |
Shareholders' Equity - Schedu58
Shareholders' Equity - Schedule of Stock Based Compensation Valuation Assumption (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Valuation assumption | ||
Dividend yield | 0.00% | |
Performance-Based Options [Member] | ||
Valuation assumption | ||
Dividend yield | 0.00% | 0.00% |
Volatility factor | 80.40% | 77.10% |
Risk-free interest rate | 2.10% | 1.50% |
Expected life (years) | 5 years 2 months 12 days | 5 years 8 months 12 days |
Weighted-average fair value of options granted during the period | $ 2.64 | $ 2.68 |
Employee Options [Member] | Members of Board of Directors [Member] | Service Based Option [Member] | ||
Valuation assumption | ||
Dividend yield | 0.00% | 0.00% |
Volatility factor | 81.10% | 74.00% |
Risk-free interest rate | 2.00% | 1.40% |
Expected life (years) | 5 years 7 months 6 days | 5 years 8 months 12 days |
Weighted-average fair value of options granted during the period | $ 2.24 | $ 3.13 |
Stock Option [Member] | Employee Options [Member] | ||
Valuation assumption | ||
Dividend yield | 0.00% | |
Volatility factor | 81.70% | |
Risk-free interest rate | 1.20% | |
Expected life (years) | 2 years | |
Weighted-average fair value of options granted during the period | $ 0.90 |
Net Loss Per Common Share - Sch
Net Loss Per Common Share - Schedule of Securities Excluded from Calculation of Diluted Net Loss per Common Share (Detail) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Common Shares Underlying Convertible Notes [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 4,415 | 4,415 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 3,728 | 1,924 |
Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 613 | 152 |
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 | 263 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Benefit Plan Disclosure [Line Items] | ||
Employee's contribution on pretax basis | $ 18,000 | |
Additional contribution of employees above 50 years | 6,000 | |
Employer matching contribution expense | $ 106,000 | $ 88,000 |
Maximum [Member] | ||
Defined Benefit Plan Disclosure [Line Items] | ||
Percentage of employees' matching contributions | 3.00% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax [Line Items] | |||||||||||
Income tax benefit | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | |
Increase (decrease) in valuation allowance on deferred tax assets | $ 2,700,000 | 16,200,000 | |||||||||
Corporate tax rate | 35.00% | ||||||||||
Net deferred tax assets before valuation allowance, written down Amount | 9,000,000 | ||||||||||
California research and development tax credit carryforwards | 7,898,000 | $ 6,509,000 | $ 7,898,000 | $ 6,509,000 | |||||||
Unrecognized tax benefits | 0 | 0 | |||||||||
Interest and penalties accrued on unrecognized tax benefits | 0 | 0 | |||||||||
Scenario, Plan [Member] | |||||||||||
Income Tax [Line Items] | |||||||||||
Corporate tax rate | 21.00% | ||||||||||
General Business Tax Credit Carryforward [Member] | |||||||||||
Income Tax [Line Items] | |||||||||||
Tax credit carryforward, amount | 23,900,000 | 23,900,000 | |||||||||
Domestic Tax Authority [Member] | |||||||||||
Income Tax [Line Items] | |||||||||||
Federal net operating loss carryforwards | 71,500,000 | $ 71,500,000 | |||||||||
Net operating loss carryforwards expiration period | 2019 through 2037 | ||||||||||
California [Member] | |||||||||||
Income Tax [Line Items] | |||||||||||
Net operating loss carryforwards expiration period | 2018 through 2037 | ||||||||||
Net operating loss carryforwards | 44,100,000 | $ 44,100,000 | |||||||||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||||||||||
Income Tax [Line Items] | |||||||||||
California research and development tax credit carryforwards | $ 9,900,000 | $ 9,900,000 |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income (Loss) Before Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||||||||||
United Sates | $ (11,465) | $ (31,594) | ||||||||
International | 760 | (1,344) | ||||||||
Income (loss) before income taxes | $ (4,176) | $ (3,886) | $ 1,035 | $ (3,678) | $ (7,937) | $ (8,186) | $ (8,729) | $ (8,086) | $ (10,705) | $ (32,938) |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Company's Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 18,267 | $ 25,536 |
Research and development credits | 7,898 | 6,509 |
Federal orphan drug credits | 23,881 | 18,599 |
Other | 1,483 | 3,572 |
Total deferred tax assets | 51,529 | 54,216 |
Valuation allowance | (51,529) | (54,216) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Schedule of Diff
Income Taxes - Schedule of Difference Between Income Tax Benefit and Computation Amount of Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||||||||||
Income tax benefit at federal statutory rate | $ (3,746) | $ (11,531) | ||||||||
State taxes (net of federal) | (8) | (391) | ||||||||
Credits | (3,434) | (4,932) | ||||||||
Other | 67 | 694 | ||||||||
Change in valuation allowance | (1,931) | 16,160 | ||||||||
Tax Rate Change | 9,052 | |||||||||
Total | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Quarterly Results of Operatio65
Quarterly Results of Operations - Summary of Quarterly Results of Operations (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | ||||||||||
Total revenue | $ 2,369 | $ 2,728 | $ 7,675 | $ 1,693 | $ 125 | $ 50 | $ 14 | $ 6 | $ 14,465 | $ 195 |
Operating expenses: | ||||||||||
Research and development | 3,704 | 3,543 | 3,794 | 2,774 | 5,865 | 5,836 | 6,235 | 6,451 | 13,815 | 24,387 |
General and administrative | 1,870 | 2,133 | 1,911 | 1,678 | 1,339 | 1,460 | 1,385 | 1,644 | 7,592 | 5,828 |
Restructuring and asset impairment | 1 | 1 | 2 | |||||||
Total expenses | 5,574 | 5,676 | 5,705 | 4,452 | 7,204 | 7,296 | 7,621 | 8,096 | 21,407 | 30,217 |
Loss from operations | (3,205) | (2,948) | 1,970 | (2,759) | (7,079) | (7,246) | (7,607) | (8,090) | (6,942) | (30,022) |
Interest income (expense), net | (969) | (947) | (937) | (925) | (913) | (864) | (551) | 4 | ||
Other income (expense) | (2) | 9 | 2 | 6 | 55 | (76) | (571) | 15 | (598) | |
Income (loss) before income taxes | (4,176) | (3,886) | 1,035 | (3,678) | (7,937) | (8,186) | (8,729) | (8,086) | (10,705) | (32,938) |
Income tax provision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Income (net loss and comprehensive loss) | $ (4,176) | $ (3,886) | $ 1,035 | $ (3,678) | $ (7,937) | $ (8,186) | $ (8,729) | $ (8,086) | $ (10,705) | $ (32,938) |
Basic and diluted net income (loss) per common share | $ (0.28) | $ (0.26) | $ 0.07 | $ (0.25) | $ (0.54) | $ (0.55) | $ (0.59) | $ (0.55) | $ (0.72) | $ (2.23) |
Shares used in computing basic net income (loss) per common share | 14,931 | 14,860 | 14,847 | 14,800 | ||||||
Shares used in computing basic and diluted net loss per common share | 14,795 | 14,782 | 14,778 | 14,761 | ||||||
Shares used in computing diluted net income (loss) per common share | $ 14,931 | $ 14,860 | $ 14,848 | $ 14,800 |
Going Concern - Additional Info
Going Concern - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Going Concern [Abstract] | |||
Accumulated deficit | $ (455,170) | $ (438,419) | |
Net loss | (10,705) | (32,938) | |
Current assets | 7,684 | 24,801 | |
Current liabilities | 5,466 | 5,848 | |
Increase in current assets | 2,200 | ||
Cash and cash equivalents | $ 7,095 | $ 22,591 | $ 31,462 |
Existence of substantial doubt about going concern, within one year | false |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | Jan. 11, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Commitments And Contingencies [Line Items] | |||
Percentage increase in annual minimum rental payments | 3.50% | ||
Deferred rent | $ 32,000 | $ 0 | |
New funding to be raised before lease termination notice date | 20,000,000 | ||
One-time tenant improvement allowance | 364,000 | ||
Base rental expenses | 492,000 | 587,000 | |
Payments related to indemnifications | 0 | 0 | |
Liabilities related to indemnifications obligation | $ 0 | $ 0 | |
Subsequent Event [Member] | |||
Commitments And Contingencies [Line Items] | |||
Lawsuit filing date | Jan. 11, 2018 | ||
Putative class action lawsuit | On January 11, 2018 a putative class action lawsuit, Kevin Kheder v. Aradigm Corporation, et al., No. 3:18-cv-00261, was filed in the United States District Court for the Northern District of California against the Company and two of its former officers. |
Commitments and Contingencies68
Commitments and Contingencies - Future Minimum Rental Payments Required under the Operating Lease (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Operating Leases, Future Minimum Payments Due, Rolling Maturity [Abstract] | |
2,018 | $ 482 |
2,019 | 499 |
2,020 | 516 |
2,021 | 535 |
2,022 | 553 |
Thereafter | 140 |
Total | $ 2,725 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] | Feb. 09, 2018 |
Executive Officer [Member] | |
Subsequent Event [Line Items] | |
Percentage of reduction of annual base salary | 50.00% |
Board Of Directors [Member] | |
Subsequent Event [Line Items] | |
Percentage of reduction of cash compensation | 50.00% |