Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 07, 2016 | Jun. 30, 2015 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
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 | 14,761,351 | ||
Entity Public Float | $ 38,322,138 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 31,462 | $ 47,990 |
Restricted cash | 250 | |
Receivables | 150 | 1,058 |
Prepaid and other current assets | 3,634 | 1,207 |
Total current assets | 35,246 | 50,505 |
Property and equipment, net | 299 | 502 |
Other assets | 81 | 2,956 |
Total assets | 35,626 | 53,963 |
Current liabilities: | ||
Accounts payable | 1,789 | 2,706 |
Accrued clinical and cost of other studies | 4,315 | 2,070 |
Accrued compensation | 1,159 | 819 |
Deferred revenue-related party | 790 | |
Deferred rent | 37 | |
Facility lease exit obligation | 104 | 193 |
Other accrued liabilities | 112 | 191 |
Total current liabilities | 7,516 | 6,769 |
Accrued clinical and cost of other studies, non-current | 33 | |
Deferred rent, non-current | 97 | |
Facility lease exit obligation, non-current | 104 | |
Deferred revenue- related party, non-current | 5,000 | 7,845 |
Total liabilities | $ 12,516 | $ 14,848 |
Commitments and contingencies (Note 8) | ||
Shareholders' equity: | ||
Preferred stock, 5,000,000 shares authorized, none outstanding | ||
Common stock, no par value; authorized shares: 25,045,765 at December 31, 2015 and December 31, 2014; issued and outstanding shares:14,761,351 at December 31, 2015; 14,726,960 at December 31, 2014 | $ 428,591 | $ 427,387 |
Accumulated deficit | (405,481) | (388,272) |
Total shareholders' equity | 23,110 | 39,115 |
Total liabilities and shareholders' equity | $ 35,626 | $ 53,963 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
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 | 25,045,765 | 25,045,765 |
Common stock, shares issued | 14,761,351 | 14,726,960 |
Common stock, shares outstanding | 14,761,351 | 14,726,960 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue: | ||
Contract revenue-related party (Note 6) | $ 23,372 | $ 33,038 |
Grant revenue | 57 | 323 |
Royalty revenue | 200 | |
Total revenues | 23,429 | 33,561 |
Operating expenses: | ||
Research and development | 35,276 | 31,172 |
General and administrative | 5,294 | 6,226 |
Restructuring and asset impairment | 11 | 19 |
Total operating expenses | 40,581 | 37,417 |
Loss from operations | (17,152) | (3,856) |
Interest income | 29 | 17 |
Interest expense | (288) | |
Other expense, net | (86) | (85) |
Gain on assignment of royalty interests | 5,823 | |
Gain from extinguishment of debt | 3,041 | |
Net income (loss) and comprehensive income (loss) | $ (17,209) | $ 4,652 |
Basic net income (loss) per common share | $ (1.17) | $ 0.32 |
Diluted net income (loss) per common share | $ (1.17) | $ 0.32 |
Shares used in computing basic net income (loss) per common share | 14,747 | 14,700 |
Shares used in computing diluted net income (loss) per common share | 14,747 | 14,726 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2013 | $ 33,683 | $ 426,607 | $ (392,924) |
Beginning Balance, Shares at Dec. 31, 2013 | 14,681,274 | ||
Issuance of common stock under the employee stock purchase plan | 157 | $ 157 | |
Issuance of common stock under the employee stock purchase plan, Shares | 33,161 | ||
Issuance of restricted stock awards | 0 | $ 0 | 0 |
Issuance of restricted stock awards, Shares | 11,250 | ||
Exercise of options | 7 | $ 7 | |
Exercise of options, Shares | 1,275 | ||
Non-cash stock-based compensation expense for stock options, restricted stock and restricted stock units | 616 | $ 616 | |
Net income (loss) | 4,652 | 4,652 | |
Ending Balance at Dec. 31, 2014 | 39,115 | $ 427,387 | (388,272) |
Ending Balance, Shares at Dec. 31, 2014 | 14,726,960 | ||
Issuance of common stock under the employee stock purchase plan | 154 | $ 154 | |
Issuance of common stock under the employee stock purchase plan, Shares | 30,891 | ||
Exercise of options | 21 | $ 21 | |
Exercise of options, Shares | 3,500 | ||
Non-cash stock-based compensation expense for stock options, restricted stock and restricted stock units | 1,029 | $ 1,029 | |
Net income (loss) | (17,209) | (17,209) | |
Ending Balance at Dec. 31, 2015 | $ 23,110 | $ 428,591 | $ (405,481) |
Ending Balance, Shares at Dec. 31, 2015 | 14,761,351 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | ||
Net income (loss) | $ (17,209) | $ 4,652 |
Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities: | ||
Depreciation and amortization | 203 | 310 |
Stock-based compensation expense | 1,029 | 616 |
Gain on assignment of royalty interests | (5,823) | |
Gain from extinguishment of debt | (3,041) | |
Amortization of note discount | 19 | |
Changes in operating assets and liabilities: | ||
Restricted cash | 250 | (250) |
Receivables | 908 | (966) |
Prepaid and other current assets | (2,427) | 241 |
Other assets | 2,875 | (2,840) |
Accounts payable | (917) | 2,087 |
Accrued compensation | 340 | 621 |
Current deferred revenue-related party | (790) | (3,589) |
Accrued liabilities | 2,133 | 428 |
Deferred rent | (60) | (35) |
Deferred revenue-related party, non-current | (2,845) | 7,845 |
Facility lease exit obligation | (193) | (168) |
Net cash (used in) provided by operating activities | (16,703) | 107 |
Cash flows from investing activities: | ||
Capital expenditures | (412) | |
Net cash used in investing activities | (412) | |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock | 175 | 164 |
Net cash provided by financing activities | 175 | 164 |
Net decrease in cash and cash equivalents | (16,528) | (141) |
Cash and cash equivalents at beginning of year | 47,990 | 48,131 |
Cash and cash equivalents at end of year | $ 31,462 | 47,990 |
Supplemental disclosure of cash flow information: | ||
Non cash reduction in other assets from extinguishment of debt and assignment of royalty interests | (237) | |
Non cash reduction in note payable from extinguishment of debt and assignment of royalty interests | $ (9,101) |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
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”) is a California corporation, incorporated in 1991, focused on the development and commercialization of drugs delivered by inhalation for the prevention and treatment 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 in 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. Liquidity and Financial Condition The Company has incurred significant operating losses and negative cash flows from operations. At December 31, 2015, the Company had an accumulated deficit of approximately $405.5 million, working capital of approximately $27.7 million and shareholders’ equity of approximately $23.1 million. The Company believes that its cash and cash equivalents totaling approximately $31.5 million as of December 31, 2015 will be sufficient to fund its operations at least through 2016. However, the Company will need to raise additional capital in 2016 to maintain the Company’s current level of product development activity. Accordingly, the Company anticipates raising additional capital in 2016, through the issuance of debt or equity securities, strategic transactions or otherwise, to fund the Company’s operations and continue the development of the Company’s leading product candidate Pulmaquin. 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. Use of Estimates The preparation of financial statements, in conformity with United States generally accepted accounting principles, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. Cash Equivalents All highly liquid investments with maturities of three months or less at the time of purchase are classified as cash equivalents. Property and Equipment The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment includes external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software includes capitalized computer software. All of the Company’s capitalized software is purchased; the Company has no internally developed computer software. Leasehold improvements are amortized over the shorter of the term of the lease or useful life of the improvement. The estimated useful lives of property and equipment are as follows: Computer equipment and software 3 to 5 years Furniture and fixtures 5 to 7 years Lab equipment 5 to 7 years Machinery and equipment 5 years Leasehold improvements 5 to 17 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 Income (Loss). 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 Contract revenues consist of revenues from grants, collaboration agreements and feasibility studies. License and collaboration revenue is primarily generated through agreements with strategic partners for the development and commercialization of our product candidates. The terms of the agreement typically include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones and royalties on net product sales. The Company recognizes revenue under the provisions of the Securities and Exchange Commission issued Staff Accounting Bulletin 104, Topic 13, Revenue Recognition Revised and Updated ( Revenue Recognition-Multiple Elements. Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Multiple-deliverable arrangements, such as license and development agreements, are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price method and the appropriate revenue recognition principles are applied to each unit. When the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. The Company estimates its performance period used for revenue recognition based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Significant management judgment may be required to determine the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. The Company prospectively adopted the provisions of Accounting Standards Update No. 2009-13, Revenue Recognition (Topic 605); Multiple-Deliverable Revenue Arrangements The Company allocates non-contingent consideration to each stand-alone deliverable based upon the relative selling price of each element. When applying the relative selling price method, the Company determines the selling price for each deliverable using vendor-specific objective evidence, or VSOE, of selling price, if it exists, or third-party evidence, or TPE, of selling price, if it exists. If neither VSOE nor TPE of selling price exist for a deliverable, the Company uses best estimated selling price, or BESP, for that deliverable. Assuming the elements meet the revenue recognition guidelines, the revenue recognition methodology prescribed for each unit of accounting is summarized below: Upfront Fees Funded Research and Development and Grant Revenue Milestones Royalties— 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. Stock-Based Compensation The Company accounts for share-based payment arrangements in accordance with ASC 718, Compensation-Stock Compensation ASC 505-50, Equity-Equity Based Payments to Non-Employees Income Taxes The Company makes certain estimates and judgments in determining income tax expense for consolidated financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of 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, 2015 and 2014, 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 equivalent shares, such as stock options and unvested restricted stock shares outstanding during the period. Unvested restricted stock awards subject to repurchase totaled 300 shares for both the years ended December 31, 2015 and 2014. Potentially dilutive securities were included for the year ended December 31, 2014 but were excluded for the year ended December 31, 2015 because the inclusion of such shares would have had an anti-dilutive effect. Potentially dilutive securities include the following (in thousands): Years Ended December 31, 2015 2014 Outstanding stock options 947 515 Unvested stock units 10 10 Outstanding warrants 71 71 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 Recently Issued Accounting Pronouncements In January 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-01, Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items, (“ASU 2015-01”). This ASU eliminates from U.S. GAAP the concept of Extraordinary Items. ASU 2015-01 is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted, provided that the guidance is applied from the beginning of the fiscal year of adoption. The guidance may be applied prospectively or retrospectively. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. In April 2015, the FASB issued ASU No. 2015-08, Presentation of Financial Statements (Topic 205) and Property, Plant, and Equipment (Topic 360): Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity (“ASU 2015-08”) which raises the threshold for a disposal to qualify as a discontinued operation and requires new disclosures of both discontinued operations and certain other disposals that do not meet the definition of a discontinued operation. ASU 2015-08 is effective for annual periods beginning on or after December 15, 2015. Early adoption is permitted but only for disposals that have not been reported in financial statements previously issued. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. In May 2015, the FASB issued ASU No. 2015-09, Revenue from Contracts with Customers (“ASU 2015-09”). 2015-14, In June 2015, the FASB issued ASU No. 2015-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period. (“ASU 2015-12”). The standard provides guidance that a performance target that affects vesting of a share-based payment and that could be achieved after the requisite service condition is a performance condition. As a result, the target is not reflected in the estimation of the award’s grant date fair value. Compensation cost for such award would be recognized over the required service period, if it is probable that the performance condition will be achieved. ASU 2015-12 is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted. The guidance should be applied on a prospective basis to awards that are granted or modified on or after the effective date. Companies also have the option to apply the amendments on a modified retrospective basis for performance targets outstanding on or after the beginning of the first annual period presented as of the adoption date. The Company is in the process of evaluating the impact of adoption on its consolidated financial statements. In August 2015, the FASB issued ASU No. 2015-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. (“ASU 2015-15”). This ASU provides guidance about management’s responsibility to evaluate whether there is substantial doubt about the organization’s ability to continue as a going concern and provides principles and definitions that are intended to reduce diversity in the timing and content of disclosures that are commonly provided by organizations today in the financial statement footnotes. ASU 2015-15 In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes, requiring all deferred tax assets and liabilities, and any related valuation allowance, to be classified as non-current on the balance sheet. The classification change for all deferred taxes as non-current simplifies entities’ processes as it eliminates the need to separately identify the net current and net non-current deferred tax asset or liability in each jurisdiction and allocate valuation allowances. Early adoption is permitted. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases, requiring lessee’s to recognize assets and liabilities for leases with lease terms of more than 12 months in the balance sheet. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new guidance is effective for fiscal years and for interim periods within those fiscal years, beginning after December 15, 2018. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact of the adoption on its consolidated financial statements. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 12 Months Ended |
Dec. 31, 2015 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | 2. Cash and Cash Equivalents At December 31, 2015 and December 31, 2014, the amortized cost of 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, 2015 | |
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, 2015 and December 31, 2014 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, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment consist of the following (in thousands): December 31, 2015 2014 Machinery and equipment $ 4,783 $ 4,792 Furniture and fixtures 1,144 1,139 Lab equipment 2,138 2,138 Computer equipment and software 2,679 2,682 Leasehold improvements 1,844 1,844 Property and equipment 12,588 12,595 Less accumulated depreciation and amortization (12,289 ) (12,093 ) Property and equipment, net $ 299 $ 502 Depreciation expense was $203,000 and $310,000 for the years ended December 31, 2015 and 2014, respectively. |
Sublease Agreement and Lease Ex
Sublease Agreement and Lease Exit Liability | 12 Months Ended |
Dec. 31, 2015 | |
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 Biotechnology, Inc. (“Mendel”) to lease approximately 48,000 square feet of the Company’s 72,000 square foot headquarters facility located in Hayward, California. 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, 2015 2014 Balance at beginning of year $ 297 $ 465 Accretion expense 11 19 Lease payments (204 ) (187 ) Balance at end of the year $ 104 $ 297 The Company classified all of the $104,000 lease exit liability in current liabilities in the accompanying Consolidated Balance Sheet at December 31, 2015. |
Collaboration Agreement
Collaboration Agreement | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreement | 6. Collaboration Agreement Grifols License and Collaboration Agreement On May 20, 2013, the Company and Grifols, S.A., (“Grifols”) and certain other investors (the “Investors”) entered into a Stock Purchase Agreement (the “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 a total of 5,244,363 shares of the Company’s common stock (“Common Stock”) to Grifols and an additional 3,104,838 shares of Common Stock to the Investors, for a total sale of 8,349,201 shares of Common Stock (the “Company Stock Sale”) for a purchase price of $4.96 per share. The aggregate gross consideration paid to the Company in August 2013 in the Company Stock Sale was approximately $41.4 million. In conjunction with signing the Stock Purchase Agreement, the Company and Grifols agreed to enter into a License and Collaboration Agreement (the “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 will be recognized as related party transactions. The License Agreement exclusively licenses the Company’s inhaled liposomal ciprofloxacin compounds for the indication of non-cystic fibrosis bronchiectasis and other indications (the “Program”) to Grifols on a worldwide basis. Grifols funds development expenses of up to $65 million for the first indication of non-cystic fibrosis bronchiectasis with all other indications fully funded by Grifols and will commercialize products from the Program (“Products”), and pay development milestones and royalties on future commercial sales of Products. The License Agreement is described further below. On July 15, 2013 shareholders of the Company (i) approved certain amendments to the Company’s charter including amendments necessary to increase the total number of shares of Common Stock authorized to be issued by the Company to at least 17,670,765 shares, including the 8,349,201 shares to be sold in the Company Stock Sale (the “Charter Amendment”) and (ii) approved the Company’s closing of the Company Stock Sale and entering into the License Agreement, Governance Agreement and other agreements described below and in the Stock Purchase Agreement (the “Transactions”). Shareholders of the Company holding more than 50% of the outstanding shares of the Company’s Common Stock voted in favor of these proposals at a special meeting. The closing of the Transactions was subject to certain closing conditions, including, among others the Company’s entering into binding terms with a third party to commercially manufacture Products to permit the Company to satisfy its obligation to commercially supply Grifols with Products. All conditions to the closing of the Transactions were met as of August 27, 2013 and the Company Stock Sale was completed on August 27, 2013. In August of 2013 Grifols paid approximately $26.0 million for the shares of the Company’s common stock at a purchase price of $4.96 per share, which reflected the contractual price for the Company’s common stock as stated in the Stock Purchase Agreement on May 20, 2013. Following the announcement of the collaboration, execution of a supply agreement and satisfaction of the other conditions of closing, the stock price rose to $8.00 per share at the time of closing. Consequently, the contractual price of $4.96 per share resulted in a $3.04 per share discount from the August 27, 2013 closing price of $8.00 per share, a discount of approximately $15.9 million from the fair market value of the common stock on the effective date of the Grifols License and Collaboration Agreement. The Company determined this transaction was not within the scope of ASC 605-25 and, accordingly, the Company recorded the sale of common stock to Grifols at fair value based on the closing price of the Company’s stock on August 27, 2013 at $8.00 per share. This discount, which is a non-cash charge, has been recorded as Collaboration Arrangement Acquisition Cost in the Company’s Consolidated Statement of Operations and Comprehensive Loss for the year ended December 31, 2013. License Agreement The License Agreement was signed simultaneously with the closing of the Company Stock Sale. Under the License Agreement, the Company granted to Grifols an exclusive license to the Program, the lead product candidate of which is named Pulmaquin. The license permits Grifols to commercialize Products throughout the world and grants Grifols a back-up manufacturing right to produce Products. The Company is responsible for developing the Product for non-cystic fibrosis bronchiectasis or pulmonary infections associated with non-cystic fibrosis bronchiectasis, in accordance with an agreed upon development plan and pursuant to a Grifols-funded budget of $65 million (which includes allocations for the Company’s internal, fully-burdened expenses). Any excess expenses are the responsibility of the Company. The Company will develop the Product for additional indications at Grifols’ sole expense if Grifols elects to pursue such development. Pursuant to the License Agreement, the Company recognized reimbursements of development costs from Grifols as Contract revenue—related party totaling $23.4 million for the year ended December 31, 2015, for the reimbursement of fully burdened development expenses for collaboration services performed and costs incurred related to the development of Pulmaquin for non-cystic fibrosis bronchiectasis. 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 to use 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 suppliers acceptable to Grifols. Grifols will purchase Products from the Company on a cost pass-through basis plus a margin. 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 Pulmaquin for non-cystic fibrosis bronchiectasis management, Grifols will pay to Aradigm reimbursements of development costs up to $65 million and development milestone payments of up to $25 million. Additionally, royalty payments on a country-by-country basis on net sales at a rate of either 12.5% or 20% (depending on the amount of net sales) for so long as there is patent coverage or orphan drug designation (or, if longer, 10 years), except that payments will be reduced by half on a country-by-country basis in the event that another inhaled liposomal product containing ciprofloxacin is being sold for an indication for which the Aradigm product has regulatory approval. Royalty payments may also be reduced by 50% if Aradigm has no valid patent claim or orphan drug protection in that country. The Company’s deliverables include an exclusive license for inhaled ciprofloxacin compounds for the indication of non-cystic fibrosis bronchiectasis and other indications, payment of development costs over $65 million for the non-cystic fibrosis bronchiectasis indication and participation on a Joint Steering Committee (“JSC”). Having determined that both the development and JSC do not have standalone value from the license, the Company combined these deliverables into a single unit of accounting. The Company is recognizing reimbursements of development expenses as collaboration services are performed and costs are incurred. During the years ended December 31, 2015 and December 31, 2014, the Company recognized $23.4 million and $33.0 million, respectively, in contract revenue—related party relating to services performed and costs incurred during the period under the License Agreement. In addition, the Company has a current deferred revenue balance at December 31, 2015 of $5.0 million representing a milestone payment which was received upon the dosing of the first patient in a Phase III clinical trial. The $5.0 million milestone payment will be recognized as revenue upon receiving the first regulatory approval. Pursuant to the License Agreement, the Company recognized reimbursements of development costs from Grifols as Contract revenue—related party totaling $23.4 million for the year ended December 31, 2015. As of December 31, 2015, the Company has utilized the full amount of the $65 million of Grifols-funded budget provided under the License Agreement and will not be recognizing any future revenue related to the $65 million Grifols-funded budget. The Company recognized $33.0 million from Grifols as Contract revenue—related party for the year ended December 31, 2014 for the reimbursement of fully burdened development expenses for collaboration services performed and costs incurred related to the development of Pulmaquin for non-cystic fibrosis bronchiectasis. Costs incurred under the Grifols License Agreement in the quarters ended December 31, 2015 and 2014 are zero and $8.1 million, respectively. Costs incurred under the Grifols License Agreement for the years ended December 31, 2015 and 2014 are $23.4 million and $33.0 million, respectively. Research and development expenses incurred under the Grifols License Agreement for the years ended December 31, 2015 and 2014 are $22.2 million and $30.2 million, respectively. General and administrative expenses incurred under the Grifols License Agreement for the years ended December 31, 2015 and 2014 are $1.2 million and $2.4 million, respectively. In addition, there are $0.4 million in development costs for equipment and inventory recorded on the Consolidated Balance Sheets as of December 31, 2014. Research and development expenses under the Grifols License Agreement decreased approximately $8.0 million and general and administrative expenses decreased approximately $1.2 million as the $65 million expense reimbursement cap was reached in 2015. Development expenses are fully burdened and include direct costs reported as research and development expenses and collaboration-related general and administrative expenses. Governance Agreement The 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 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 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 (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% (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. 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 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 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 (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 will be entitled to require the Company to file with the SEC certain registration statements under the Securities Act of 1933, as amended (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 and up to six times on Form S-3, and to include its shares of Common Stock in any registration the Company proposes for its own account or for the account of one or more of its shareholders. In connection with and concurrently with the closing of the Company Stock Sale, the Company and the Investors also entered into a Registration Rights Agreement (the “Investors Registration Rights Agreement”). Pursuant to the Investors Registration Rights Agreement, the Company is required to file a registration statement to cover the resale of the shares of the Common Stock acquired by the investors in the Company Stock Sale. The failure on the part of the Company to satisfy the deadlines set forth in the Investors Registration Rights Agreement may subject the Company to payment of certain monetary penalties. In addition, pursuant to the terms of the Stock Purchase Agreement, the Company has agreed, among other things, not to file any other registration statement (other than any registration statement on Form S-4 or Form S-8, and subject to certain other limitations and exclusions) until the Common Stock subject thereto is covered by an effective registration statement or freely salable under Rule 144 under the Securities Act. |
Royalty Agreement, Note Payable
Royalty Agreement, Note Payable, and Accrued Interest | 12 Months Ended |
Dec. 31, 2015 | |
Text Block [Abstract] | |
Royalty Agreement, Note Payable, and Accrued Interest | 7. Royalty Agreement, Note Payable, and Accrued Interest Zogenix In August 2006, the Company sold all assets related to its needle-free injector technology platform and products, including 12 U.S. patents along with foreign counterparts, to Zogenix, Inc. In July 2009, Zogenix was granted approval by the U.S. Food and Drug Administration (“FDA”) of the SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system for the treatment of acute migraine and cluster headache. The Company was entitled to quarterly royalty payments of 3% of net sales on all SUMAVEL DosePro sales. The Company recorded royalty revenue of approximately $0.2 million for the twelve months ended December 31, 2014. Royalty Financing In June 2011, the Company entered into an $8.5 million royalty financing agreement with a syndicate of lenders. The agreement created a debt obligation (the “Term Loan”) that will be repaid through and secured by royalties from net sales of the SUMAVEL DosePro needle-free delivery system payable to the Company under its Asset Purchase Agreement (“APA”) with Zogenix. The Company capitalized the fees and expenses of approximately $473,000 and recorded this amount in other assets. The capitalized expenses were to be amortized to interest expense using the effective interest method over a period of 48 months, however, the full amount of the remaining capitalized fees and expenses were recognized in the three months ended March 31, 2014, which was the accounting period following the completion of the transfer of payment rights to the lenders as described below. In connection with the original royalty financing transaction, the Company issued to the lenders warrants to purchase a total of 71,022 shares of the Company’s common stock (2,840,909 shares prior to the 1-for-40 Reverse Split) at a strike price of $8.80 per share ($0.22 per share prior to the 1-for-40 Reverse Split), representing a 20% premium above the average closing price of the Company’s common stock for the ten trading days immediately preceding the closing of the royalty financing transaction. The warrants expire on December 31, 2016. In accordance with Accounting Standards Topic 815— Derivatives and Hedging While the term loan was non-recourse to the assets of Aradigm Corporation, the term loan agreement contained a minimum royalty covenant. If the minimum royalty covenant was breached and the subsidiary did not cure the breach through a cash contribution to pay down the accrued principal and interest, then the lenders had the right to declare the agreement in default and obtain the right to all future royalties and payments due to Aradigm under the Zogenix asset purchase agreement. In 2012, the minimum royalty covenant was breached and the Company made cash payments of approximately $167,000 to the lenders for accrued interest in order to cure the breach. In the twelve months ended December 31, 2013, the covenant was again breached and the cumulative cash shortfall the Company would need to contribute to keep the agreement from default stood at $525,000. In the first quarter of 2014, the Company elected not to make this or any future contributions. On March 4, 2014, the Company and the other parties executed an Assignment Agreement that transferred the rights to the lenders, effective February 28, 2014, for all future royalty payments from Zogenix under the APA in full and complete satisfaction of the Company’s obligations under the loan agreement and the other agreements entered into in connection with the royalty financing. Under the Assignment Agreement, the parties agreed that the value of the Assigned Interest is $5.8 million. Zogenix consented to the Assignment. The Company valued the assignment of the royalty rights at $5.8 million in the Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) in accordance with the Assignment Agreement which was recorded as a gain on fair value of assigned royalty rights in the quarter ended March 31, 2014. The balance of the note payable and accrued interest extinguished in the transaction offset by deferred loan costs and unamortized debt discount as of the assignment date less the fair value of the royalty rights resulted in a gain from debt extinguishment of $3.0 million which was recognized in the quarter ended March 31, 2014 in the Condensed Consolidated Statement of Operations and Comprehensive Income (Loss). All debts and obligations of Aradigm and its subsidiary are considered to be paid and satisfied in full. |
Leases, Commitments and Conting
Leases, Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Leases, Commitments and Contingencies | 8. Leases, Commitments and Contingencies The Company has a lease for a building containing offices, laboratory and manufacturing facilities, which expires in 2016. A portion of this lease obligation was offset by a sublease to Mendel Biotechnology, Inc. (“Mendel”). Future minimum non-cancelable lease payments at December 31, 2015 are as follows (in thousands): Operating Leases Mendel Sub-Lease Net Operating Lease Payments Year ending December 31: 2016 $ 1,020 $ (640 ) $ 380 Total minimum lease payments $ 1,020 $ (640 ) $ 380 In July 2007, the Company entered into a sublease agreement with Mendel to lease approximately 48,000 square feet of its 72,000 square foot headquarters located in Hayward, California. The Company’s monthly rent payments fluctuate under the master lease. In accordance with U.S. generally accepted accounting principles, the Company recognizes rent expense on a straight-line basis. The Company records deferred rent for the difference between the amounts paid and recorded as expense. At December 31, 2015 and 2014, the Company had $37,000 and $97,000 of deferred rent, respectively. For the years ended December 31, 2015 and 2014, building rent expense under operating leases totaled $591,000 and $593,000, respectively. Indemnification 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, 2015 or 2014. Legal Matters From time to time, the Company is involved in litigation arising out of the ordinary course of its business. Currently there are no known claims or pending litigation expected to have a material effect on the Company’s overall financial position, results of operations, or liquidity. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Equity [Abstract] | |
Shareholders' Equity | 9. Shareholders’ Equity Reserved Shares At December 31, 2015, the Company had 947,142 shares reserved for future issuance upon exercise of options under all stock option plans and 252,725 shares of common stock reserved for future issuance of new option grants. The Company had 114,293 shares available for future issuances under the ESPP. Additionally, the Company had 71,023 shares reserved for outstanding warrants. 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 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 (the “2015 Plan”). The 2015 Plan replaces the Company’s 2005 Equity Incentive 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 directors, officers, employees, advisors, consultants and independent contractors, and allows the flexibility to grant a variety of awards to eligible individuals, thereby strengthening their commitment to the Company’s success and aligning their interests with those of the Company’s shareholders. The Company did not request that shareholders authorize any new shares of Common Stock in connection with the approval of the 2015 Plan; rather, the shares authorized for issuance under the 2005 Plan are now available for issuance under the 2015 Plan. 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 stock options. For incentive and non-statutory stock option grants, the option price shall be at least 100% and 85%, respectively, of the fair value on the date of grant, as determined by the Company’s Board of Directors. If at any time the Company grants an option, and the optionee directly or by attribution owns stock possessing more than 10% of the total combined voting power of all classes of stock of the Company, the option price shall be at least 110% of the fair value and shall not be exercisable more than five years after the date of grant. 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, 2015 and 2014, 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 Company granted options to purchase 604,657 shares and 338,121 shares during the years ended December 31, 2015 and 2014, respectively, under both Plans, which included option grants to the Company’s non-employee directors in the amount of 59,820 and 21,875 shares during 2015 and 2014, respectively. As of December 31, 2015 the Company had 947,142 options outstanding and 252,725 shares were available for future grants under the 2015 Plan. The following is a summary of activity under the 2005 Plan and the 2015 Plan as of December 31, 2015: Stock Options Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at December 31, 2014 515,366 $ 15.55 Options granted 604,657 $ 7.78 Options cancelled (169,381 ) $ 11.26 Options exercised (3,500 ) $ 6.00 Outstanding at December 31, 2015 947,142 $ 11.40 7.88 $ — Ending Vested and Expected To Vest 922,926 $ 11.48 7.86 $ — Ending Exercisable 306,281 $ 18.41 5.90 $ — The weighted-average grant-date fair value of options granted during the years 2015 and 2014 was $4.95 and $7.57, respectively. The intrinsic value of exercised stock options is calculated based on the difference between the exercise price and the quoted market price of our common stock as of close of the exercise date. The total intrinsic value of stock options exercised in fiscal years 2015 and 2014 was $2,100 and $3,500, respectively. A summary of the activity of the Company’s unvested restricted stock and performance bonus stock award activities for the year ending December 31, 2015 is presented below. The ending balance represents the maximum number of shares that could be earned or vested under the 2005 Plan: Restricted Stock Awards Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2014 300 57.60 Restricted stock awards granted — — Restricted share awards vested — — Outstanding at December 31, 2015 300 57.60 As of December 31, 2015, there was no unrecognized compensation cost related to restricted stock award arrangements granted under the Plans. Recipients of restricted stock do not pay cash consideration for the shares and have the right to vote all shares subject to the grant. Stock compensation expense for the awards has been recognized in the appropriate period. The total fair value of restricted stock awards vested during the years ended December 31, 2015 and 2014 was zero and $247,000, respectively. The Company retained purchase rights to 300 shares of unvested restricted stock awards issued pursuant to stock purchase agreements at no cost per share as of December 31, 2015 and 2014, respectively. Restricted Stock Units Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2014 10,306 5.34 Restricted stock units granted — — Restricted share units vested — — Outstanding at December 31, 2015 10,306 5.34 As of December 31, 2015, 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, 2015 and 2014 was zero for both years. 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, 2015, a total of 171,957 shares had been issued under the ESPP. In April 2008, the Company’s Board of Directors amended, and in May 2008 the Company’s shareholder approved, the amendment to the ESPP increasing the shares of common stock authorized by 25,000. In April 2009, the Company’s Board of Directors amended, and in May 2009 the Company’s shareholders approved, the amendment to the ESPP increasing the number of shares of common stock authorized by 62,500. In March 2013, the Company’s Board of Directors amended, and in May 2013 the Company’s shareholders approved, the amendment to the ESPP increasing the number of shares of common stock authorized by 62,500. In March 2015, the Company’s Board of Directors amended, and in May 2015 the Company’s shareholders approved, the amendment to the ESPP increasing the number of shares of common stock authorized by 110,000. As of December 31, 2015, there was a balance of 114,293 available authorized shares. Compensation expense was $104,000 and $67,000 for the years ended December 31, 2015 and 2014, respectively. The fair value of employee stock purchase rights under the ESPP is determined using the Black-Scholes option pricing model and the following weighted average assumptions: Years Ended December 31, 2015 2014 Employee Stock Purchase Plan Dividend yield 0.0 % 0.0 % Volatility factor 65.6 % 65.1 % Risk-free interest rate 0.06 % 0.07 % Expected life (years) 2.00 0.50 Weighted-average fair value of purchase rights granted during the period $ 3.38 $ 3.20 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 Income (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 Income (loss) for the years ended December 31, 2015 and 2014, (in thousands, except per share amounts): 2015 2014 Costs and Expenses Research and development $ 522 $ 197 General and administrative 507 419 Total employee stock-based compensation expense $ 1,029 $ 616 Impact on basic and diluted net income (loss) per common share $ (0.07 ) $ 0.04 There was no capitalized stock-based compensation expense as of December 31, 2015. Since the Company has cumulative net losses through December 31, 2015, 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 net of forfeitures was $2,185,000 as of December 31, 2015. This amount will be recognized over a weighted average period of 2.12 years. As of December 31, 2015, there is no unrecognized compensation expenses, net of forfeitures, related to unvested awards that is expected to be recognized. Valuation Assumptions The fair value of options was estimated at the date of grant using the Black-Scholes option pricing model. Expected volatility is based on the historical volatility of the Company’s common stock for similar terms. The expected term was estimated using a lattice model prior to 2010, and the simplified method was used starting in 2010 as permitted under SAB No. 110, since the Company’s recent exercise and forfeiture history was not representative of the expected term of options granted during the year. The expected term represents the estimated period of time that stock options are expected to be outstanding, which is less than the contractual term which is generally ten years. The risk-free interest rate is based on the U.S. Treasury yield. The expected dividend yield is zero, as the Company does not anticipate paying dividends in the near future. The weighted average assumptions for employee options (which for purposes of this table includes members of the board of directors) are as follows: Years Ended December 31 2015 2014 Dividend yield 0.0 % 0.0 % Volatility factor 83.9 % 110.0 % Risk-free interest rate 1.7 % 1.8 % Expected term (years) 5.7 6.0 Weighted-average fair value of options granted during the periods $ 4.95 $ 7.57 The weighted average assumptions for non-employee options, except for members of the board of directors which are reflected above, are as follows: Years Ended December 31 2015 2014 Dividend yield 0.0 % — Volatility factor 91.1 % — Risk-free interest rate 1.7 % — Expected term (years) 10.0 — Weighted-average fair value of options granted during the periods $ 6.47 — Stock-Based Compensation for Non-Employees The Company accounts for options issued to non-employees under ASC 505-50, Equity—Equity Based Payments to Non-Employees, |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plans | 10. 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 2015 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 $47,000 and $55,000 in 2015 and 2014, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes In 2015 and 2014, 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. Significant components of the Company’s deferred tax assets and liabilities were as follows (in thousands): December 31, 2015 2014 Net operating loss carryforwards $ 18,406 $ 14,955 Research and development credits 6,509 6,509 Federal orphan drug credits 11,011 7,217 Other 2,130 1,152 Total deferred tax assets 38,056 29,833 Valuation allowance (38,056 ) (29,833 ) 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, 2015 and 2014, 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 increased by $8.2 million during the year ended December 31, 2015 and decreased by $1.9 million during the year ended December 31, 2014. In accordance with ASC 718 Compensation-Stock Compensation 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, 2015 2014 Income tax benefit at federal statutory rate $ (6,016 ) $ 1,657 State taxes (net of federal) (17 ) 11 Credits (2,466 ) — Other 276 129 Change in valuation allowance 8,223 (1,797 ) Total $ — $ — As of December 31, 2015, the Company had federal net operating loss carryforwards of approximately $45.4 million and federal orphan drug credit carryforwards of approximately $11.0 million, which expire in the years 2019 through 2035. The Company also had California net operating loss carryforwards of approximately $39.0 million, which expire in the years 2016 through 2035, and California research and development tax credit carryforwards of approximately $9.9 million, which do not expire. None of the federal and state net operating loss carryforwards represent stock option deductions arising from activity under the Company’s stock option plan. The Company’s federal and state net operating loss (NOL’s) and tax credit carryforwards are subject to substantial annual limitations as a result of certain ownership changes that occurred in 2010 and prior years. Federal net operating loss (NOL) carryforwards totaling $45.4 million will begin to expire from 2019 to 2035, subject to the annual limitations. Federal tax credit carryforwards totaling $11.1 million will begin to expire from 2028 to 2035, subject to the annual limitations. State operating loss carryforwards totaling $39.0 million will begin to expire from 2016 to 2035, subject to annual limitations. State tax credit carryforwards may be subject to further annual limitations for ownership changes occurring after December 31, 2015. 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, 2015, 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. The Company does not have any unrecognized tax benefits, or interest and penalties accrued on unrecognized tax benefits, at December 31, 2015, 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, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results of Operations | 12. Quarterly Results of Operations (unaudited) Following is a summary of the quarterly results of operations for the years ended December 31, 2015 and 2014 (in thousands, except per share data): March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015 Total revenue $ 8,768 $ 9,952 $ 4,674 $ 35 Operating expenses: Research and development 8,361 9,754 8,880 8,281 General and administrative 1,542 1,339 1,320 1,093 Restructuring and asset impairment 4 3 2 2 Total expenses 9,907 11,096 10,202 9,376 Loss from operations (1,139 ) (1,144 ) (5,528 ) (9,341 ) Interest income/(expense), net 8 7 7 7 Other expense (32 ) (8 ) (28 ) (18 ) Loss before income taxes (1,163 ) (1,145 ) (5,549 ) (9,352 ) Income tax provision — — — — Net loss and comprehensive loss $ (1,163 ) $ (1,145 ) $ (5,549 ) $ (9,352 ) Basic and diluted net loss per common share $ (0.08 ) $ (0.08 ) $ (0.38 ) $ (0.63 ) Shares used in computing basic and diluted net loss per common share 14,727 14,749 14,751 14,761 March 31, 2014 June 30, 2014 September 30, 2014 December 31, 2014 Total revenues $ 6,631 $ 12,245 $ 6,617 $ 8,068 Operating expenses: Research and development 5,796 11,656 6,047 7,673 General and administrative 1,651 1,931 1,443 1,201 Restructuring and asset impairment 6 5 4 4 Total expenses 7,453 13,592 7,494 8,878 Loss from operations (822 ) (1,347 ) (877 ) (810 ) Interest income (expense), net (286 ) 1 5 9 Other expense (1 ) (12 ) (42 ) (30 ) Gain on assignment of royalty interests 5,823 — — — Gain on extinguishment of debt 3,041 — — — Income (loss) before income taxes 7,755 (1,358 ) (914 ) (831 ) Income tax provision — — — — Net income (loss) and comprehensive income (loss) $ 7,755 $ (1,358 ) $ (914 ) $ (831 ) Basic net income (loss) per common share $ 0.53 $ (0.09 ) $ (0.06 ) $ (0.06 ) Diluted net income (loss) per common share $ 0.53 $ (0.09 ) $ (0.06 ) $ (0.06 ) Shares used in computing basic net income (loss) per common share 14,669 14,697 14,706 14,726 Shares used in computing diluted net income (loss) per common share 14,713 14,697 14,706 14,726 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events The Company has evaluated subsequent events that have occurred after December 31, 2015 and determined that there were no events or transactions occurring during this reporting period which require recognition or disclosure in the consolidated financial statements. |
Organization and Summary of S20
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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. |
Liquidity and Financial Condition | Liquidity and Financial Condition The Company has incurred significant operating losses and negative cash flows from operations. At December 31, 2015, the Company had an accumulated deficit of approximately $405.5 million, working capital of approximately $27.7 million and shareholders’ equity of approximately $23.1 million. The Company believes that its cash and cash equivalents totaling approximately $31.5 million as of December 31, 2015 will be sufficient to fund its operations at least through 2016. However, the Company will need to raise additional capital in 2016 to maintain the Company’s current level of product development activity. Accordingly, the Company anticipates raising additional capital in 2016, through the issuance of debt or equity securities, strategic transactions or otherwise, to fund the Company’s operations and continue the development of the Company’s leading product candidate Pulmaquin. 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. |
Use of Estimates | Use of Estimates The preparation of financial statements, in conformity with United States generally accepted accounting principles, requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include useful lives for property and equipment and related depreciation calculations, assumptions for valuing options and warrants, and income taxes. Actual results could differ from these estimates. |
Cash Equivalents | Cash Equivalents All highly liquid investments with maturities of three months or less at the time of purchase are classified as cash equivalents. |
Property and Equipment | Property and Equipment The Company records property and equipment at cost and calculates depreciation using the straight-line method over the estimated useful lives of the respective assets. Machinery and equipment includes external costs incurred for validation of the equipment. The Company does not capitalize internal validation expense. Computer equipment and software includes capitalized computer software. All of the Company’s capitalized software is purchased; the Company has no internally developed computer software. Leasehold improvements are amortized over the shorter of the term of the lease or useful life of the improvement. The estimated useful lives of property and equipment are as follows: Computer equipment and software 3 to 5 years Furniture and fixtures 5 to 7 years Lab equipment 5 to 7 years Machinery and equipment 5 years Leasehold improvements 5 to 17 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 Income (Loss). |
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 Contract revenues consist of revenues from grants, collaboration agreements and feasibility studies. License and collaboration revenue is primarily generated through agreements with strategic partners for the development and commercialization of our product candidates. The terms of the agreement typically include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones and royalties on net product sales. The Company recognizes revenue under the provisions of the Securities and Exchange Commission issued Staff Accounting Bulletin 104, Topic 13, Revenue Recognition Revised and Updated ( Revenue Recognition-Multiple Elements. Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed and determinable and collection is reasonably assured. Multiple-deliverable arrangements, such as license and development agreements, are analyzed to determine whether the deliverables can be separated or whether they must be accounted for as a single unit of accounting. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price method and the appropriate revenue recognition principles are applied to each unit. When the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. The Company estimates its performance period used for revenue recognition based on the specific terms of each agreement, and adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Significant management judgment may be required to determine the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. The Company prospectively adopted the provisions of Accounting Standards Update No. 2009-13, Revenue Recognition (Topic 605); Multiple-Deliverable Revenue Arrangements The Company allocates non-contingent consideration to each stand-alone deliverable based upon the relative selling price of each element. When applying the relative selling price method, the Company determines the selling price for each deliverable using vendor-specific objective evidence, or VSOE, of selling price, if it exists, or third-party evidence, or TPE, of selling price, if it exists. If neither VSOE nor TPE of selling price exist for a deliverable, the Company uses best estimated selling price, or BESP, for that deliverable. Assuming the elements meet the revenue recognition guidelines, the revenue recognition methodology prescribed for each unit of accounting is summarized below: Upfront Fees Funded Research and Development and Grant Revenue Milestones Royalties— |
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. |
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, Equity-Equity Based Payments to Non-Employees |
Income Taxes | Income Taxes The Company makes certain estimates and judgments in determining income tax expense for consolidated financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of 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, 2015 and 2014, 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 equivalent shares, such as stock options and unvested restricted stock shares outstanding during the period. Unvested restricted stock awards subject to repurchase totaled 300 shares for both the years ended December 31, 2015 and 2014. Potentially dilutive securities were included for the year ended December 31, 2014 but were excluded for the year ended December 31, 2015 because the inclusion of such shares would have had an anti-dilutive effect. Potentially dilutive securities include the following (in thousands): Years Ended December 31, 2015 2014 Outstanding stock options 947 515 Unvested stock units 10 10 Outstanding warrants 71 71 |
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 |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In January 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-01, Simplifying Income Statement Presentation by Eliminating the Concept of Extraordinary Items, (“ASU 2015-01”). This ASU eliminates from U.S. GAAP the concept of Extraordinary Items. ASU 2015-01 is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted, provided that the guidance is applied from the beginning of the fiscal year of adoption. The guidance may be applied prospectively or retrospectively. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. In April 2015, the FASB issued ASU No. 2015-08, Presentation of Financial Statements (Topic 205) and Property, Plant, and Equipment (Topic 360): Reporting Discontinued Operations and Disclosures of Disposals of Components of an Entity (“ASU 2015-08”) which raises the threshold for a disposal to qualify as a discontinued operation and requires new disclosures of both discontinued operations and certain other disposals that do not meet the definition of a discontinued operation. ASU 2015-08 is effective for annual periods beginning on or after December 15, 2015. Early adoption is permitted but only for disposals that have not been reported in financial statements previously issued. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. In May 2015, the FASB issued ASU No. 2015-09, Revenue from Contracts with Customers (“ASU 2015-09”). The standard provides companies with a single model for use in accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance, including industry-specific revenue guidance. The core principle of the model is to recognize revenue when control of the goods or services transfers to the customer, as opposed to recognizing revenue when the risks and rewards transfer to the customer under the existing revenue guidance. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606) (“ASU 2015-14”), Deferral of the Effective Date. With the issuance of ASU 2015-14, the new revenue guidance ASU 2014-09 as amended by ASU 2015-14 is effective for annual reporting periods beginning after December 15, 2017. Early adoption is permitted as of the original effective date for ASU 2015-09 for annual reporting periods beginning after December 15, 2016, but otherwise earlier adoption is not permitted. The guidance permits companies to either apply the requirements retrospectively to all prior periods presented, or apply the requirements in the year of adoption, through a cumulative adjustment. The Company is in the process of evaluating the impact of adoption on its consolidated financial statements. In June 2015, the FASB issued ASU No. 2015-12, Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period. (“ASU 2015-12”). The standard provides guidance that a performance target that affects vesting of a share-based payment and that could be achieved after the requisite service condition is a performance condition. As a result, the target is not reflected in the estimation of the award’s grant date fair value. Compensation cost for such award would be recognized over the required service period, if it is probable that the performance condition will be achieved. ASU 2015-12 is effective for annual reporting periods beginning after December 15, 2015. Early adoption is permitted. The guidance should be applied on a prospective basis to awards that are granted or modified on or after the effective date. Companies also have the option to apply the amendments on a modified retrospective basis for performance targets outstanding on or after the beginning of the first annual period presented as of the adoption date. The Company is in the process of evaluating the impact of adoption on its consolidated financial statements. In August 2015, the FASB issued ASU No. 2015-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. (“ASU 2015-15”). This ASU provides guidance about management’s responsibility to evaluate whether there is substantial doubt about the organization’s ability to continue as a going concern and provides principles and definitions that are intended to reduce diversity in the timing and content of disclosures that are commonly provided by organizations today in the financial statement footnotes. ASU 2015-15 is effective for annual periods ending after December 15, 2016, and interim periods within annual periods beginning after December 15, 2016. Early application is permitted for annual or interim reporting periods for which the financial statements have not previously been issued. The Company is in the process of evaluating the impact of adoption on its consolidated financial statements. In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes, requiring all deferred tax assets and liabilities, and any related valuation allowance, to be classified as non-current on the balance sheet. The classification change for all deferred taxes as non-current simplifies entities’ processes as it eliminates the need to separately identify the net current and net non-current deferred tax asset or liability in each jurisdiction and allocate valuation allowances. Early adoption is permitted. The adoption of this guidance is not expected to have an impact on the Company’s consolidated financial statements. In February 2016, the FASB issued ASU No. 2016-02, Leases, requiring lessee’s to recognize assets and liabilities for leases with lease terms of more than 12 months in the balance sheet. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new guidance is effective for fiscal years and for interim periods within those fiscal years, beginning after December 15, 2018. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company is currently evaluating the impact of the adoption on its consolidated financial statements. |
Organization and Summary of S21
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Estimated Useful Lives of Property and Equipment | The estimated useful lives of property and equipment are as follows: Computer equipment and software 3 to 5 years Furniture and fixtures 5 to 7 years Lab equipment 5 to 7 years Machinery and equipment 5 years Leasehold improvements 5 to 17 years |
Summary of Potentially Dilutive Securities | Potentially dilutive securities include the following (in thousands): Years Ended December 31, 2015 2014 Outstanding stock options 947 515 Unvested stock units 10 10 Outstanding warrants 71 71 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following (in thousands): December 31, 2015 2014 Machinery and equipment $ 4,783 $ 4,792 Furniture and fixtures 1,144 1,139 Lab equipment 2,138 2,138 Computer equipment and software 2,679 2,682 Leasehold improvements 1,844 1,844 Property and equipment 12,588 12,595 Less accumulated depreciation and amortization (12,289 ) (12,093 ) Property and equipment, net $ 299 $ 502 |
Sublease Agreement and Lease 23
Sublease Agreement and Lease Exit Liability (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Lease Exit Liability Activity | The lease exit liability activity for the years ended December 31, 2015 and 2014 are as follows (in thousands): Year Ended December 31, 2015 2014 Balance at beginning of year $ 297 $ 465 Accretion expense 11 19 Lease payments (204 ) (187 ) Balance at end of the year $ 104 $ 297 |
Leases, Commitments and Conti24
Leases, Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Non-Cancelable Lease Payments | Future minimum non-cancelable lease payments at December 31, 2015 are as follows (in thousands): Operating Leases Mendel Sub-Lease Net Operating Lease Payments Year ending December 31: 2016 $ 1,020 $ (640 ) $ 380 Total minimum lease payments $ 1,020 $ (640 ) $ 380 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Schedule of Activity Under Stock Option Plan | The following is a summary of activity under the 2005 Plan and the 2015 Plan as of December 31, 2015: Stock Options Number of Shares Weighted Average Exercise Price Weighted Aggregate Outstanding at December 31, 2014 515,366 $ 15.55 Options granted 604,657 $ 7.78 Options cancelled (169,381 ) $ 11.26 Options exercised (3,500 ) $ 6.00 Outstanding at December 31, 2015 947,142 $ 11.40 7.88 $ — Ending Vested and Expected To Vest 922,926 $ 11.48 7.86 $ — Ending Exercisable 306,281 $ 18.41 5.90 $ — |
Employee Stock Purchase Plan | The fair value of employee stock purchase rights under the ESPP is determined using the Black-Scholes option pricing model and the following weighted average assumptions: Years Ended December 31, 2015 2014 Employee Stock Purchase Plan Dividend yield 0.0 % 0.0 % Volatility factor 65.6 % 65.1 % Risk-free interest rate 0.06 % 0.07 % Expected life (years) 2.00 0.50 Weighted-average fair value of purchase rights granted during the period $ 3.38 $ 3.20 |
Schedule of Stock-Based Compensation Expense | The following table shows stock-based compensation expense included in the Consolidated Statement of Operations and Comprehensive Income (loss) for the years ended December 31, 2015 and 2014, (in thousands, except per share amounts): 2015 2014 Costs and Expenses Research and development $ 522 $ 197 General and administrative 507 419 Total employee stock-based compensation expense $ 1,029 $ 616 Impact on basic and diluted net income (loss) per common share $ (0.07 ) $ 0.04 |
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 bonus stock award activities for the year ending December 31, 2015 is presented below. The ending balance represents the maximum number of shares that could be earned or vested under the 2005 Plan: Restricted Stock Awards Number of Shares Weighted Average Grant Date Fair Value Outstanding at December 31, 2014 300 57.60 Restricted stock awards granted — — Restricted share awards vested — — Outstanding at December 31, 2015 300 57.60 |
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 December 31, 2014 10,306 5.34 Restricted stock units granted — — Restricted share units vested — — Outstanding at December 31, 2015 10,306 5.34 |
Employee Options [Member] | |
Schedule of Stock Based Compensation Valuation Assumption | The weighted average assumptions for employee options (which for purposes of this table includes members of the board of directors) are as follows: Years Ended December 31 2015 2014 Dividend yield 0.0 % 0.0 % Volatility factor 83.9 % 110.0 % Risk-free interest rate 1.7 % 1.8 % Expected term (years) 5.7 6.0 Weighted-average fair value of options granted during the periods $ 4.95 $ 7.57 |
Non-Employee Options [Member] | |
Schedule of Stock Based Compensation Valuation Assumption | The weighted average assumptions for non-employee options, except for members of the board of directors which are reflected above, are as follows: Years Ended December 31 2015 2014 Dividend yield 0.0 % — Volatility factor 91.1 % — Risk-free interest rate 1.7 % — Expected term (years) 10.0 — Weighted-average fair value of options granted during the periods $ 6.47 — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
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, 2015 2014 Net operating loss carryforwards $ 18,406 $ 14,955 Research and development credits 6,509 6,509 Federal orphan drug credits 11,011 7,217 Other 2,130 1,152 Total deferred tax assets 38,056 29,833 Valuation allowance (38,056 ) (29,833 ) 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, 2015 2014 Income tax benefit at federal statutory rate $ (6,016 ) $ 1,657 State taxes (net of federal) (17 ) 11 Credits (2,466 ) — Other 276 129 Change in valuation allowance 8,223 (1,797 ) Total $ — $ — |
Quarterly Results of Operatio27
Quarterly Results of Operations (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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, 2015 and 2014 (in thousands, except per share data): March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015 Total revenue $ 8,768 $ 9,952 $ 4,674 $ 35 Operating expenses: Research and development 8,361 9,754 8,880 8,281 General and administrative 1,542 1,339 1,320 1,093 Restructuring and asset impairment 4 3 2 2 Total expenses 9,907 11,096 10,202 9,376 Loss from operations (1,139 ) (1,144 ) (5,528 ) (9,341 ) Interest income/(expense), net 8 7 7 7 Other expense (32 ) (8 ) (28 ) (18 ) Loss before income taxes (1,163 ) (1,145 ) (5,549 ) (9,352 ) Income tax provision — — — — Net loss and comprehensive loss $ (1,163 ) $ (1,145 ) $ (5,549 ) $ (9,352 ) Basic and diluted net loss per common share $ (0.08 ) $ (0.08 ) $ (0.38 ) $ (0.63 ) Shares used in computing basic and diluted net loss per common share 14,727 14,749 14,751 14,761 March 31, 2014 June 30, 2014 September 30, 2014 December 31, 2014 Total revenues $ 6,631 $ 12,245 $ 6,617 $ 8,068 Operating expenses: Research and development 5,796 11,656 6,047 7,673 General and administrative 1,651 1,931 1,443 1,201 Restructuring and asset impairment 6 5 4 4 Total expenses 7,453 13,592 7,494 8,878 Loss from operations (822 ) (1,347 ) (877 ) (810 ) Interest income (expense), net (286 ) 1 5 9 Other expense (1 ) (12 ) (42 ) (30 ) Gain on assignment of royalty interests 5,823 — — — Gain on extinguishment of debt 3,041 — — — Income (loss) before income taxes 7,755 (1,358 ) (914 ) (831 ) Income tax provision — — — — Net income (loss) and comprehensive income (loss) $ 7,755 $ (1,358 ) $ (914 ) $ (831 ) Basic net income (loss) per common share $ 0.53 $ (0.09 ) $ (0.06 ) $ (0.06 ) Diluted net income (loss) per common share $ 0.53 $ (0.09 ) $ (0.06 ) $ (0.06 ) Shares used in computing basic net income (loss) per common share 14,669 14,697 14,706 14,726 Shares used in computing diluted net income (loss) per common share 14,713 14,697 14,706 14,726 |
Organization and Summary of S28
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015USD ($)Segmentshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) | |
Summary Of Organization And Operations [Line Items] | |||
Number of operating segment | Segment | 1 | ||
Accumulated deficit | $ (405,481) | $ (388,272) | |
Working capital | 27,700 | ||
Shareholders' equity | 23,110 | 39,115 | $ 33,683 |
Cash and cash equivalents | $ 31,462 | $ 47,990 | $ 48,131 |
Unvested Restricted Stock [Member] | |||
Summary Of Organization And Operations [Line Items] | |||
Company retained purchase rights on unvested restricted stock awards, shares | shares | 300 | 300 |
Organization and Summary of S29
Organization and Summary of Significant Accounting Policies - Summary of Estimated Useful Lives of Property and Equipment (Detail) | 12 Months Ended |
Dec. 31, 2015 | |
Minimum [Member] | Computer Equipment and Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 3 years |
Minimum [Member] | Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Minimum [Member] | Lab Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Minimum [Member] | Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Maximum [Member] | Computer Equipment and Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Maximum [Member] | Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 7 years |
Maximum [Member] | Lab Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 7 years |
Maximum [Member] | Machinery and Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 5 years |
Maximum [Member] | Leasehold Improvements [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment, estimated useful life | 17 years |
Organization and Summary of S30
Organization and Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities (Detail) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 947 | 515 |
Unvested Restricted Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 10 | 10 |
Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Dilutive securities outstanding | 71 | 71 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 12,588 | $ 12,595 |
Less accumulated depreciation and amortization | (12,289) | (12,093) |
Property and equipment, net | 299 | 502 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 4,783 | 4,792 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 1,144 | 1,139 |
Lab Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 2,138 | 2,138 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | 2,679 | 2,682 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment | $ 1,844 | $ 1,844 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 203 | $ 310 |
Sublease Agreement and Lease 33
Sublease Agreement and Lease Exit Liability - Additional Information (Detail) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015USD ($) | Dec. 31, 2007USD ($) | Dec. 31, 2014USD ($) | 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 | |||
Lease exit current liability | $ | $ 104 | $ 193 | ||
Mendel [Member] | ||||
Lease Rental Expenses [Line Items] | ||||
Sublease agreement, number of square feet | ft² | 48,000 |
Sublease Agreement and Lease 34
Sublease Agreement and Lease Exit Liability - Schedule of Lease Exit Liability Activity (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Leases [Abstract] | ||
Balance at beginning of year | $ 297 | $ 465 |
Accretion expense | 11 | 19 |
Lease payments | (204) | (187) |
Balance at end of the year | $ 104 | $ 297 |
Collaboration Agreement - Grifo
Collaboration Agreement - Grifols License and Collaboration Agreement - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Jul. 15, 2013 | May. 20, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Common stock, shares issued and sell | 14,761,351 | 14,726,960 | |||
Sale of common stock | $ 41,400 | $ 428,591 | $ 427,387 | ||
Common stock, shares authorized | 25,045,765 | 25,045,765 | 17,670,765 | ||
Shareholders holding percentage | 50.00% | ||||
Payment received from investors and related party | $ 175 | $ 164 | |||
Before Stock Split [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Common stock, shares issued and sell | 8,349,201 | ||||
Common stock, purchase price per share | $ 4.96 | ||||
License Agreement with Grifols [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Reimbursable research and development expenses by partner | $ 65,000 | ||||
Grifols [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Stock Purchase Agreement | May 20, 2013 | ||||
Payment received from investors and related party | $ 26,000 | ||||
Closing price of common stock | $ 8 | ||||
Common stock discount per share | $ 3.04 | ||||
Common stock discount on share | $ 15,900 | ||||
Grifols [Member] | Before Stock Split [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Common stock, shares issued and sell | 5,244,363 | ||||
Investors [Member] | Before Stock Split [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Common stock, shares issued and sell | 3,104,838 |
Collaboration Agreement - Licen
Collaboration Agreement - License Agreement - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Contract revenue-related party | $ 23,372 | $ 33,038 | ||||||||
Deferred revenue | $ 5,000 | 5,000 | ||||||||
Milestone payment will be recognized as revenue upon receiving the first regulatory approval | 5,000 | 5,000 | ||||||||
Fully utilized reimbursable research and development expenses | 65,000 | 65,000 | ||||||||
Research and development | 8,281 | $ 8,880 | $ 9,754 | $ 8,361 | $ 7,673 | $ 6,047 | $ 11,656 | $ 5,796 | 35,276 | 31,172 |
General and administrative | 1,093 | $ 1,320 | $ 1,339 | $ 1,542 | 1,201 | $ 1,443 | $ 1,931 | $ 1,651 | 5,294 | 6,226 |
License Agreement with Grifols [Member] | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Reimbursable research and development expenses by partner | 65,000 | |||||||||
Payments for development milestones by partner | $ 25,000 | |||||||||
Patent coverage or orphan drug designation period | 10 years | |||||||||
Percentage of reduction on royalty payment | 50.00% | |||||||||
Fully burdened development expenses | $ 0 | $ 8,100 | $ 23,400 | 33,000 | ||||||
Research and development | 22,200 | 30,200 | ||||||||
General and administrative | 1,200 | 2,400 | ||||||||
Development costs for equipment and inventory | $ 400 | |||||||||
Decrease in research and development expenses | 8,000 | |||||||||
Decrease in general and administrative expenses | $ 1,200 | |||||||||
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% |
Collaboration Agreement - Gover
Collaboration Agreement - Governance Agreement - Additional Information (Detail) - Governance Agreement [Member] | 12 Months Ended |
Dec. 31, 2015Person | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Number of independent directors | 3 |
Number of directors designated by partner | 2 |
Number of chief executive officer | 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 | 35.00% |
Royalty Agreement, Note Payab38
Royalty Agreement, Note Payable, and Accrued Interest - Additional Information (Detail) | May. 23, 2014 | Aug. 31, 2006Patents | Mar. 31, 2014USD ($) | Jun. 30, 2011USD ($)$ / sharesshares | Dec. 31, 2015 | Dec. 31, 2014USD ($) | Dec. 31, 2012USD ($) | Dec. 31, 2013USD ($) |
Debt Instrument [Line Items] | ||||||||
U.S. patents along with foreign counterparts | Patents | 12 | |||||||
Quarterly royalty payments rate | 3.00% | |||||||
Royalty revenue | $ 200,000 | |||||||
Royalty financing agreement with a syndicate of lenders | $ 8,500,000 | |||||||
Capitalization of fees expenses | $ 473,000 | |||||||
Lender warrants to purchase common stock | shares | 71,022 | |||||||
Lender warrants to purchase common stock, before stock split | shares | 2,840,909 | |||||||
Class of warrant or right, exercise price of warrants or rights | $ / shares | $ 8.80 | |||||||
Class of warrant or right, exercise price of warrants or rights, before stock split | $ / shares | $ 0.22 | |||||||
Common stock premium rate | 20.00% | |||||||
Number of trading days for the average closing price | 10 days | |||||||
Warrants expiration date | Dec. 31, 2016 | |||||||
Warrants account for as equity instrument, fair value | $ 390,000 | |||||||
Discount interest rate | 18.70% | |||||||
Capitalized expenses amortization period | 48 months | |||||||
Cash payments to lenders for accrued interest | $ 167,000 | |||||||
Cumulative cash shortfall agreement from default stands | $ 525,000 | |||||||
Transferred rights, effective date | Feb. 28, 2014 | |||||||
Gain from fair value of assigned interests | $ 5,823,000 | 5,823,000 | ||||||
Gain from extinguishment of debt | $ 3,041,000 | $ 3,041,000 | ||||||
Common Stock [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Reverse stock split ratio | 1-for-40 | |||||||
Reverse stock split conversion ratio | 0.025 |
Leases, Commitments and Conti39
Leases, Commitments and Contingencies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2015USD ($)LegalMatter | Dec. 31, 2014USD ($) | Jul. 18, 2007ft² | |
Future Minimum Lease Payments Under Noncancellable Operating Leases [Line Items] | |||
Lease expiration year | 2,016 | ||
Number of square feet | ft² | 72,000 | ||
Deferred rent | $ 37,000 | $ 97,000 | |
Building rent expense | 591,000 | 593,000 | |
Payments related to indemnifications | 0 | 0 | |
Liabilities related to indemnifications obligation | $ 0 | $ 0 | |
Claims or pending litigation | LegalMatter | 0 | ||
Mendel [Member] | |||
Future Minimum Lease Payments Under Noncancellable Operating Leases [Line Items] | |||
Number of square feet | ft² | 48,000 |
Leases, Commitments and Conti40
Leases, Commitments and Contingencies - Future Minimum Non-Cancelable Lease Payments (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2016, Operating Leases | $ 1,020 |
2016, Mendel Sub-Lease | (640) |
2016, Net Operating Lease Payments | 380 |
Total minimum lease payments, Operating Leases | 1,020 |
Total minimum lease payments, Mendel Sub-Lease | (640) |
Total minimum lease payments, Net Operating Lease Payments | $ 380 |
Shareholders' Equity - Addition
Shareholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||
May. 31, 2015 | May. 31, 2013 | Apr. 30, 2008 | Dec. 31, 2015 | Dec. 31, 2014 | |
Class of Stock [Line Items] | |||||
Common stock reserves | 947,142 | ||||
Shares reserved for future grants | 252,725 | ||||
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% | ||||
Weighted-average grant-date fair value of options granted | $ 4.95 | $ 7.57 | |||
intrinsic value of stock options exercised | $ 2,100 | $ 3,500 | |||
Limitation of Employee contributions, through payroll deductions to lessor | 18,000 | ||||
Compensation expense | 1,029,000 | 616,000 | |||
Capitalized stock-based employee compensation expense | 0 | ||||
Tax benefit associated with stock-based compensation expense | $ 0 | ||||
Expected term of options granted | 10 years | ||||
Expected dividend yield | 0.00% | ||||
Unvested Restricted Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Total fair value of restricted stock awards vested | $ 0 | $ 247,000 | |||
Company retained purchase rights on unvested restricted stock awards, shares | 300 | 300 | |||
Stock Options [Member] | |||||
Class of Stock [Line Items] | |||||
Common stock reserves | 114,293 | ||||
Incentive and non-statutory stock option grants option price | 85.00% | ||||
Shares acquired vest period | 4 years | ||||
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 issued under the ESPP | 171,957 | ||||
Number of shares of common stock authorized | 110,000 | 62,500 | 25,000 | ||
Common stock authorized for issuance | 114,293 | ||||
Compensation expense | $ 104,000 | $ 67,000 | |||
Expected dividend yield | 0.00% | 0.00% | |||
Restricted Stock Units [Member] | |||||
Class of Stock [Line Items] | |||||
Total fair value of restricted stock awards vested | $ 0 | $ 0 | |||
Company retained purchase rights on unvested restricted stock awards, shares | 10,306 | 10,306 | |||
Unvested stock options and stock purchases [Member] | |||||
Class of Stock [Line Items] | |||||
Options granted expiration | 2 years 1 month 13 days | ||||
Unrecognized compensation cost related to restricted stock award arrangements granted | $ 2,185,000 | ||||
Unrecognized compensation expense | $ 0 | ||||
Non-Employee Options [Member] | Stock Options [Member] | |||||
Class of Stock [Line Items] | |||||
Options granted | 0 | ||||
Warrants [Member] | |||||
Class of Stock [Line Items] | |||||
Common stock reserves | 71,023 | ||||
2005 and 2015 Plan [Member] | |||||
Class of Stock [Line Items] | |||||
Plan expiration date | 2015-03 | ||||
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 | |||
Options granted | 604,657 | 338,121 | |||
Number of shares repurchased | 0 | ||||
2005 and 2015 Plan [Member] | Unvested Restricted Stock [Member] | |||||
Class of Stock [Line Items] | |||||
Unrecognized compensation cost related to restricted stock award arrangements granted | $ 0 | ||||
2005 and 2015 Plan [Member] | Restricted Stock Units [Member] | |||||
Class of Stock [Line Items] | |||||
Unrecognized compensation cost related to restricted stock award arrangements granted | $ 0 | ||||
2005 and 2015 Plan [Member] | Non Employee Director [Member] | |||||
Class of Stock [Line Items] | |||||
Options granted | 59,820 | 21,875 | |||
2015 Plan [Member] | |||||
Class of Stock [Line Items] | |||||
Shares reserved for future grants | 252,725 | ||||
Options outstanding | 947,142 | ||||
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 (Detail) | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Weighted Average Remaining Contractual Term | |
Outstanding at December 31, 2015 | 10 years |
Stock Options [Member] | |
Number of Shares | |
Outstanding at December 31, 2014 | shares | 515,366 |
Options granted | shares | 604,657 |
Options cancelled | shares | (169,381) |
Options exercised | shares | (3,500) |
Outstanding at December 31, 2015 | shares | 947,142 |
Ending Vested and Expected To Vest | shares | 922,926 |
Ending Exercisable | shares | 306,281 |
Weighted Average Exercise Price | |
Outstanding at December 31, 2014 | $ / shares | $ 15.55 |
Options granted | $ / shares | 7.78 |
Options cancelled | $ / shares | 11.26 |
Options exercised | $ / shares | 6 |
Outstanding at December 31, 2015 | $ / shares | 11.40 |
Ending Vested and Expected To Vest | $ / shares | 11.48 |
Ending Exercisable | $ / shares | $ 18.41 |
Weighted Average Remaining Contractual Term | |
Outstanding at December 31, 2015 | 7 years 10 months 17 days |
Ending Vested and Expected To Vest | 7 years 10 months 10 days |
Ending Exercisable | 5 years 10 months 24 days |
Aggregate Intrinsic Value | |
Outstanding at December 31, 2015 | $ | $ 0 |
Ending Vested and Expected To Vest | $ | 0 |
Ending Exercisable | $ | $ 0 |
Shareholders' Equity - Schedu43
Shareholders' Equity - Schedule of Unvested Restricted Stock and Performance Bonus Stock Awards (Detail) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Weighted Average Grant Date Fair Value | |
Outstanding at December 31, 2014 | $ / shares | $ 57.60 |
Weighted Average Grant Date Fair Value, granted | $ / shares | 0 |
Weighted Average Grant Date Fair Value, vested | $ / shares | 0 |
Outstanding at December 31, 2015 | $ / shares | $ 57.60 |
Restricted Stock Awards [Member] | |
Number of Shares | |
Outstanding at December 31, 2014 | shares | 300 |
Number of Shares, granted | shares | 0 |
Number of Shares, vested | shares | 0 |
Outstanding at December 31, 2015 | shares | 300 |
Restricted Stock Units [Member] | |
Number of Shares | |
Outstanding at December 31, 2014 | shares | 10,306 |
Number of Shares, granted | shares | 0 |
Number of Shares, vested | shares | 0 |
Outstanding at December 31, 2015 | shares | 10,306 |
Weighted Average Grant Date Fair Value | |
Outstanding at December 31, 2014 | $ / shares | $ 5.34 |
Weighted Average Grant Date Fair Value, granted | $ / shares | 0 |
Weighted Average Grant Date Fair Value, vested | $ / shares | 0 |
Outstanding at December 31, 2015 | $ / shares | $ 5.34 |
Shareholders' Equity - Employee
Shareholders' Equity - Employee Stock Purchase Plan (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Stock Purchase Plan | ||
Dividend yield | 0.00% | |
Weighted-average fair value of purchase rights granted during the period | $ 0 | |
Stock Options [Member] | ||
Employee Stock Purchase Plan | ||
Dividend yield | 0.00% | 0.00% |
Volatility factor | 65.60% | 65.10% |
Risk-free interest rate | 0.06% | 0.07% |
Expected life (years) | 2 years | 6 months |
Weighted-average fair value of purchase rights granted during the period | $ 3.38 | $ 3.20 |
Shareholders' Equity - Schedu45
Shareholders' Equity - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Costs and Expenses | ||
Total employee stock-based compensation expense | $ 1,029 | $ 616 |
Impact on basic and diluted net income (loss) per common share | $ (0.07) | $ 0.04 |
Research and Development [Member] | ||
Costs and Expenses | ||
Total employee stock-based compensation expense | $ 522 | $ 197 |
General and Administrative [Member] | ||
Costs and Expenses | ||
Total employee stock-based compensation expense | $ 507 | $ 419 |
Shareholder's Equity - Schedule
Shareholder's Equity - Schedule of Stock Based Compensation Valuation Assumption (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation assumption | ||
Dividend yield | 0.00% | |
Weighted-average fair value of options granted during the periods | $ 4.95 | $ 7.57 |
Stock Option [Member] | Employee Options [Member] | Members of Board of Directors [Member] | ||
Valuation assumption | ||
Dividend yield | 0.00% | 0.00% |
Volatility factor | 83.90% | 110.00% |
Risk-free interest rate | 1.70% | 1.80% |
Expected term (years) | 5 years 8 months 12 days | 6 years |
Weighted-average fair value of options granted during the periods | $ 4.95 | $ 7.57 |
Stock Option [Member] | Non-Employee Options [Member] | ||
Valuation assumption | ||
Dividend yield | 0.00% | |
Volatility factor | 91.10% | |
Risk-free interest rate | 1.70% | |
Expected term (years) | 10 years | 0 years |
Weighted-average fair value of options granted during the periods | $ 6.47 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
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 | $ 47,000 | $ 55,000 |
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, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
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 | 8,223,000 | (1,797,000) | ||||||||
California research and development tax credit carryforwards | 6,509,000 | $ 6,509,000 | 6,509,000 | $ 6,509,000 | ||||||
Unrecognized tax benefits | 0 | 0 | ||||||||
Interest and penalties accrued on unrecognized tax benefits | 0 | 0 | ||||||||
General Business Tax Credit Carryforward [Member] | ||||||||||
Income Tax [Line Items] | ||||||||||
Tax credit carryforward, amount | 11,000,000 | 11,000,000 | ||||||||
Domestic Tax Authority [Member] | ||||||||||
Income Tax [Line Items] | ||||||||||
Federal net operating loss carryforwards | 45,400,000 | 45,400,000 | ||||||||
Tax credit carryforward, amount | 11,100,000 | $ 11,100,000 | ||||||||
Net operating loss carryforwards expiration period | 2019 through 2035 | |||||||||
California [Member] | ||||||||||
Income Tax [Line Items] | ||||||||||
Net operating loss carryforwards expiration period | 2016 through 2035 | |||||||||
Net operating loss carryforwards | 39,000,000 | $ 39,000,000 | ||||||||
State and Local Jurisdiction [Member] | ||||||||||
Income Tax [Line Items] | ||||||||||
Net operating loss carryforwards | 39,000,000 | 39,000,000 | ||||||||
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 - Significant Comp
Income Taxes - Significant Components of Company's Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 18,406 | $ 14,955 |
Research and development credits | 6,509 | 6,509 |
Federal orphan drug credits | 11,011 | 7,217 |
Other | 2,130 | 1,152 |
Total deferred tax assets | 38,056 | 29,833 |
Valuation allowance | (38,056) | (29,833) |
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, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | ||||||||||
Income tax benefit at federal statutory rate | $ (6,016) | $ 1,657 | ||||||||
State taxes (net of federal) | (17) | 11 | ||||||||
Credits | (2,466) | |||||||||
Other | 276 | 129 | ||||||||
Change in valuation allowance | 8,223 | (1,797) | ||||||||
Total | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Quarterly Results of Operatio51
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, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Statement [Abstract] | ||||||||||
Total revenue | $ 35 | $ 4,674 | $ 9,952 | $ 8,768 | $ 8,068 | $ 6,617 | $ 12,245 | $ 6,631 | $ 23,429 | $ 33,561 |
Operating expenses: | ||||||||||
Research and development | 8,281 | 8,880 | 9,754 | 8,361 | 7,673 | 6,047 | 11,656 | 5,796 | 35,276 | 31,172 |
General and administrative | 1,093 | 1,320 | 1,339 | 1,542 | 1,201 | 1,443 | 1,931 | 1,651 | 5,294 | 6,226 |
Restructuring and asset impairment | 2 | 2 | 3 | 4 | 4 | 4 | 5 | 6 | 11 | 19 |
Total operating expenses | 9,376 | 10,202 | 11,096 | 9,907 | 8,878 | 7,494 | 13,592 | 7,453 | 40,581 | 37,417 |
Loss from operations | (9,341) | (5,528) | (1,144) | (1,139) | (810) | (877) | (1,347) | (822) | (17,152) | (3,856) |
Interest income/(expense), net | 7 | 7 | 7 | 8 | 9 | 5 | 1 | (286) | ||
Other income (expense) | (18) | (28) | (8) | (32) | (30) | (42) | (12) | (1) | (86) | (85) |
Gain on assignment of royalty interests | 5,823 | 5,823 | ||||||||
Gain from extinguishment of debt | 3,041 | 3,041 | ||||||||
Income (loss) before income taxes | (9,352) | (5,549) | (1,145) | (1,163) | (831) | (914) | (1,358) | 7,755 | ||
Income tax provision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Net income (loss) and comprehensive income (loss) | $ (9,352) | $ (5,549) | $ (1,145) | $ (1,163) | $ (831) | $ (914) | $ (1,358) | $ 7,755 | $ (17,209) | $ 4,652 |
Basic net income (loss) per common share | $ (0.06) | $ (0.06) | $ (0.09) | $ 0.53 | $ (1.17) | $ 0.32 | ||||
Basic and diluted net loss per common share | $ (0.63) | $ (0.38) | $ (0.08) | $ (0.08) | ||||||
Diluted net income (loss) per common share | $ (0.06) | $ (0.06) | $ (0.09) | $ 0.53 | $ (1.17) | $ 0.32 | ||||
Shares used in computing basic and diluted net loss per common share | 14,761 | 14,751 | 14,749 | 14,727 | ||||||
Shares used in computing basic net income (loss) per common share | 14,726 | 14,706 | 14,697 | 14,669 | 14,747 | 14,700 | ||||
Shares used in computing diluted net income (loss) per common share | 14,726 | 14,706 | 14,697 | 14,713 | 14,747 | 14,726 |