Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 26, 2018 | Jun. 30, 2017 | |
Document Information [Line Items] | |||
Entity Registrant Name | ACELRX PHARMACEUTICALS INC | ||
Entity Central Index Key | 1,427,925 | ||
Trading Symbol | acrx | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Common Stock, Shares Outstanding (in shares) | 50,899,154 | ||
Entity Public Float | $ 75,622,608 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Assets | ||
Cash and cash equivalents | $ 52,902 | $ 80,310 |
Short-term investments | 7,567 | |
Accounts receivable, net | 1,533 | 5,833 |
Inventories | 956 | 2,154 |
Prepaid expenses and other current assets | 455 | 756 |
Total current assets | 63,413 | 89,053 |
Property and equipment, net | 11,051 | 10,712 |
Restricted cash | 178 | 178 |
Long-term tax receivable | 703 | |
Other assets | 207 | 50 |
Total Assets | 75,552 | 99,993 |
Liabilities and Stockholders’ Deficit | ||
Accounts payable | 1,424 | 1,558 |
Accrued liabilities | 3,543 | 4,595 |
Long-term debt, current portion | 7,727 | 2,912 |
Deferred revenue, current portion | 362 | 362 |
Liability related to the sale of future royalties, current portion | 604 | 764 |
Total current liabilities | 13,660 | 10,191 |
Deferred rent, net of current portion | 378 | 43 |
Long-term debt, net of current portion | 11,369 | 18,637 |
Deferred revenue, net of current portion | 3,463 | 3,824 |
Liability related to the sale of future royalties, net of current portion | 82,984 | 72,223 |
Contingent put option liability | 207 | 124 |
Warrant liability | 288 | |
Total liabilities | 112,061 | 105,330 |
Commitments and Contingencies: | ||
Common stock, $0.001 par value—100,000,000 shares authorized as of December 31, 2017 and December 31, 2016; 50,899,154 and 45,333,790 shares issued and outstanding as of December 31, 2017 and December 31, 2016 | 51 | 45 |
Additional paid-in capital | 261,310 | 240,977 |
Accumulated deficit | (297,870) | (246,362) |
Accumulated other comprehensive income | 3 | |
Total stockholders’ deficit | (36,509) | (5,337) |
Total Liabilities and Stockholders’ Deficit | $ 75,552 | $ 99,993 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, issued (in shares) | 50,899,154 | 45,333,790 |
Common stock, outstanding (in shares) | 50,899,154 | 45,333,790 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue: | |||
Collaboration agreement | $ 7,143,000 | $ 6,440,000 | $ 14,857,000 |
Contract and other | 852,000 | 10,917,000 | 4,406,000 |
Total revenue | 7,995,000 | 17,357,000 | 19,263,000 |
Operating costs and expenses: | |||
Cost of goods sold | 10,659,000 | 12,315,000 | 1,770,000 |
Research and development | 19,409,000 | 21,402,000 | 22,488,000 |
General and administrative | 16,609,000 | 15,597,000 | 14,203,000 |
Restructuring costs | 756,000 | ||
Total operating costs and expenses | 46,677,000 | 49,314,000 | 39,217,000 |
Loss from operations | (38,682,000) | (31,957,000) | (19,954,000) |
Other (expense) income: | |||
Interest expense | (3,316,000) | (2,770,000) | (2,977,000) |
Interest income and other income (expense), net | 510,000 | 918,000 | 1,720,000 |
Non-cash interest expense on liability related to sale of future royalties | (10,721,000) | (9,382,000) | (2,428,000) |
Total other (expense) income | (13,527,000) | (11,234,000) | (3,685,000) |
Net loss before income taxes | (52,209,000) | (43,191,000) | (23,639,000) |
Benefit (provision) for income taxes | 701,000 | 34,000 | (760,000) |
Net loss | (51,508,000) | (43,157,000) | (24,399,000) |
Other comprehensive income (loss): | |||
Unrealized gains (losses) on available for sale securities | (3,000) | 4,000 | 3,000 |
Comprehensive loss | $ (51,511,000) | $ (43,153,000) | $ (24,396,000) |
Net loss per share of common stock, basic (in dollars per share) | $ (1.10) | $ (0.95) | $ (0.55) |
Net loss per share of common stock, diluted (in dollars per share) | $ (1.10) | $ (0.95) | $ (0.60) |
Shares used in computing net loss per share of common stock, basic (in shares) | 46,883,535 | 45,313,118 | 44,300,099 |
Shares used in computing net loss per share of common stock, diluted –see Note 14 (in shares) | 46,883,535 | 45,313,118 | 44,468,440 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2014 | 43,712,363 | ||||
Balance at Dec. 31, 2014 | $ 43 | $ 225,423 | $ (178,806) | $ (4) | $ 46,656 |
Stock-based compensation | 5,010 | 5,010 | |||
Issuance of common stock upon exercise of stock options (in shares) | 938,497 | ||||
Issuance of common stock upon exercise of stock options | $ 1 | 2,769 | $ 2,770 | ||
Issuance of common stock upon exercise of stock warrants (in shares) | 527,101 | 527,101 | |||
Issuance of common stock upon exercise of stock warrants | $ 1 | 2,543 | $ 2,544 | ||
Modification of warrants | 100 | 100 | |||
Issuance of common stock upon ESPP purchase (in shares) | 95,811 | ||||
Issuance of common stock upon ESPP purchase | 429 | 429 | |||
Change in unrealized gains and losses on investments | 3 | 3 | |||
Net loss | (24,399) | (24,399) | |||
Balance (in shares) at Dec. 31, 2015 | 45,273,772 | ||||
Balance at Dec. 31, 2015 | $ 45 | 236,274 | (203,205) | (1) | 33,113 |
Stock-based compensation | 4,479 | 4,479 | |||
Modification of warrants | 45 | 45 | |||
Issuance of common stock upon ESPP purchase (in shares) | 60,018 | ||||
Issuance of common stock upon ESPP purchase | 179 | 179 | |||
Change in unrealized gains and losses on investments | 4 | 4 | |||
Net loss | (43,157) | (43,157) | |||
Balance (in shares) at Dec. 31, 2016 | 45,333,790 | ||||
Balance at Dec. 31, 2016 | $ 45 | 240,977 | (246,362) | 3 | (5,337) |
Stock-based compensation | 4,294 | $ 4,294 | |||
Issuance of common stock upon exercise of stock options (in shares) | 69,372 | 69,372 | |||
Issuance of common stock upon exercise of stock options | 105 | $ 105 | |||
Issuance of common stock upon ESPP purchase (in shares) | 94,893 | ||||
Issuance of common stock upon ESPP purchase | 246 | 246 | |||
Change in unrealized gains and losses on investments | (3) | (3) | |||
Net loss | (51,508) | $ (51,508) | |||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 5,401,099 | 5,400,000 | |||
Net proceeds from issuance of common stock in connection with equity financings | $ 6 | 15,688 | $ 15,694 | ||
Balance (in shares) at Dec. 31, 2017 | 50,899,154 | ||||
Balance at Dec. 31, 2017 | $ 51 | $ 261,310 | $ (297,870) | $ (36,509) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (51,508) | $ (43,157) | $ (24,399) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Non-cash royalty revenue related to royalty monetization | (151) | (7) | |
Non-cash interest expense on liability related to royalty monetization | 10,721 | 9,382 | 2,428 |
Depreciation and amortization | 1,744 | 2,052 | 1,984 |
Non-cash interest expense related to debt financing | 1,265 | 877 | 897 |
Stock-based compensation | 4,294 | 4,479 | 5,010 |
Revaluation of put option and PIPE warrant liabilities | (205) | (767) | (2,136) |
Loss on disposal and impairment of property and equipment | 12 | 573 | |
Inventory impairment charge | 369 | ||
Other | (5) | 17 | 114 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 4,300 | (2,547) | (3,286) |
Inventories | 920 | (1,688) | (466) |
Prepaid expenses and other assets | 175 | 975 | (783) |
Restricted cash | 72 | ||
Tax receivable | (703) | ||
Accounts payable | 309 | (437) | (786) |
Accrued liabilities | (1,301) | 639 | 325 |
Deferred revenue | (361) | 989 | 784 |
Deferred rent | 360 | (202) | (284) |
Net cash used in operating activities | (29,765) | (29,395) | (19,953) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of property and equipment | (2,405) | (3,720) | (1,456) |
Purchase of investments | (7,565) | (996) | (7,266) |
Proceeds from maturities of investments | 6,525 | 16,925 | |
Net cash (used in) provided by investing activities | (9,970) | 1,809 | 8,203 |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from sale of future royalties | 61,184 | ||
Payment of long-term debt | (3,514) | (4,534) | |
Payment of debt modification transaction costs | (204) | (205) | (215) |
Net proceeds from issuance of common stock in connection with equity financings | 15,694 | ||
Net proceeds from issuance of common stock through equity plans | 351 | 179 | 3,199 |
Net cash provided by (used in) financing activities | 12,327 | (26) | 59,634 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (27,408) | (27,612) | 47,884 |
CASH AND CASH EQUIVALENTS—Beginning of period | 80,310 | 107,922 | 60,038 |
CASH AND CASH EQUIVALENTS—End of period | 52,902 | 80,310 | 107,922 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |||
Cash paid for interest | 2,043 | 1,893 | 2,115 |
Income taxes (refunded) paid | 2 | (55) | 782 |
NONCASH INVESTING AND FINANCING ACTIVITIES: | |||
Issuance of common stock upon cashless exercise of warrants | 2,544 | ||
Modification of warrants for common stock | 45 | 100 | |
Purchases of property and equipment in Accounts payable | 89 | 532 | 98 |
Purchases of property and equipment in Accrued liabilities | $ 133 |
Note 1 - Organization and Summa
Note 1 - Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 1. The Company AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on July 13, 2005 January 2006, ’s operations are based in Redwood City, California. AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. AcelRx’s lead product candidate, DSUVIA ™ ® not may DSUVIA DSUVIA, is a 30 was initially developed at the request of the U.S. Department of Defense as a replacement for injections of morphine on the battlefield. In addition to the military application, AcelRx is developing DSUVIA for the treatment of patients suffering from moderate-to-severe acute pain in multiple settings, such as emergency room patients; patients who are recovering from short-stay or ambulatory surgery and do not 3 February 2017 October 12, 2017, two 50 Type A post-action meeting with the FDA on January 26, 2018 second 2018, March 2017, 30 04 first 2018 . ZALVISO ZALVISO delivers 15 Liechtenstein and is in late-stage development in the U.S. The Company had initially submitted to the FDA an NDA seeking approval for ZALVISO in September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 second 2018. On December 16, 2013, nenthal GmbH, or Grünenthal, entered into a Collaboration and License Agreement, or the License Agreement, which was amended effective July 17, 2015 September 20, 2016, September 2015, 28 December 16, 2013, July 22, 2015, July 17, 2015, Grü nenthal has begun its commercial launch of ZALVISO in the European Union. Royalty revenues and non-cash royalty revenues from the commercial sales of ZALVISO in the EU are expected to be minimal for 2018 . The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although ZALVISO has been approved for sale in the EU, the Company sold the majority of the royalty rights and certain commercial sales milestones it is entitled to receive under the Amended License Agreement with Grünenthal to PDL BioPharma, Inc., or PDL. As a result, the Company expects to continue to incur operating losses and negative cash flows. When we refer to "we," "our," "us," the "Company" or "AcelRx" in this document, we mean the current Delaware corporation, or AcelRx Pharmaceuticals, Inc., and its predecessor, as well as its consolidated subsidiary. Basis of Presentation The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the Consolidated Financial Statements and the accompanying notes. Actual results could differ from those estimates. Reclassifications Certain prior year amounts in the Consolidated Financial Statements have been reclassified to conform to the current year's presentation. In particular, the amounts reported in the Consolidated Statements of Cash Flows as “Amortization of premium/discount on investments, net” have been reclassified to “Other” for the years ended December 31, 2016 December 31, 2015. Principles of Consolidation The Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiary, ARPI LLC, which was formed in September 2015 Grünenthal, pursuant to the Amended License Agreement, or the Royalty Monetization. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note 8 Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the Consolidated Financial Statements and accompanying notes. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with an original maturity (at date of purchase) of three All marketable securities are classified as available-for-sale and consist of U.S. government sponsored enterprise debt securities. These securities are carried at estimated fair value, which is based on quoted market prices or observable market inputs of almost identical assets, with unrealized gains and losses included in accumulated other comprehensive income (loss). The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income or expense. The cost of securities sold is based on specific identification. The Company ’s investments are subject to a periodic impairment review for other-than-temporary declines in fair value. The Company’s review includes the consideration of the cause of the impairment including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in the market value. When the Company determines that the decline in fair value of an investment is below its accounting basis and this decline is other-than-temporary, it reduces the carrying value of the security it holds and records a loss in the amount of such decline. Fair Value of Financial Instruments The Company measures and reports its cash equivalents, investments and financial liabilities at fair value. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three Level I —Unadjusted quoted prices in active markets for identical assets or liabilities; Level II —Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not Level III —Unobservable inputs that are supported by little or no The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Segment Information The Company operates in a single segment, the development and commercialization of product candidates for the treatment of pain. The Company ’s contract revenue relates to sales in the United States. The Company’s collaboration revenue relates to the Amended License Agreement with Grünenthal to commercialize ZALVISO in the countries of the European Union, Switzerland, Liechtenstein, Iceland, Norway and Australia. Concentration of Risk The Company invests cash that is currently not s. The Company relies on a single third ZALVISO, and various sole-source third To date, the Company has had only two two 100% December 31, 2017, 2016 2015. 79% December 31, 2017, 71% 84% December 31, 2016 2015, The Company has not accounts receivable and believes that the entire accounts receivable balance as of December 31, 2017 Accounts Receivable, Net The Company has receivables from its collaboration partner and the U.S. Department of Defense, or DoD. To date, the Company has not ’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in bad debt. Inventories Inventories are valued at the lower of cost and net realizable value. Cost is determined using the first first third Indirect overhead costs in excess of normal capacity are recorded as period costs in the period incurred. The Company's policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or market approach as that used to value the inventory. During the year ended December 31, 2017, $0.4 Because selling prices to Grünenthal are set to recover only direct costs with minimal mark up, all inventories are carried at net realizable value. Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally three five Expenditures for repairs and maintenance, which do not Impairment of Long-Lived Assets The Company periodically assesses the impairment of long-lived assets and, if indicators of asset impairment exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through an analysis of the undiscounted future expected operating cash flows. If impairment is indicated, the Company records the amount of such impairment for the excess of the carrying value of the asset over its estimated fair value. For example, purchased equipment and manufacturing-related facility improvements the Company has made at Patheon ’s facility in Ohio, are utilized for continued research and development, commercial manufacturing of ZALVISO for Grünenthal and potential commercialization of its other product candidates. If the Company does not may no September 30, 2015, $0.5 December 31, 2015, December 31, 2017, not Restricted Cash Under the Company ’s facility lease and corporate credit card agreements, the Company is required to maintain letters of credit as security for performance under these agreements. The letters of credit are secured by certificates of deposit in amounts equal to the letters of credit, which are classified as restricted cash on the Consolidated Balance Sheets. Debt Issuance Costs Debt issuance costs, which are included in long-term debt, net of current portion, are amortized as interest expense over the contractual terms of the related credit facilities. Contingent put option The contingent put option associated with the Company ’s loan and security agreement with Hercules Technology II, L.P. and Hercules Technology Growth Capital, Inc., collectively referred to as the Lenders, is recorded as a liability. Changes in the fair value of the contingent put option are recognized as interest income and other income (expense), net in the Consolidated Statements of Comprehensive Loss. For additional information regarding the contingent put option, see Note 7 Warrants Warrants issued in connection with the Company ’s Private Placement, completed in June 2012, 9 Revenue Recognition The Company recognizes revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the fee is fixed or determinable; and collectability is reasonably assured. Collaboration Revenue Collaboration revenue, which is earned under license agreements with third may AcelRx accounts for multiple-element arrangements in accordance with ASC Topic 605 25, Revenue Recognition—Multiple-Element Arrangements 605 25. not For revenue agreements with multiple-element arrangements, such as the collaboration and license agreement with Grünenthal, the Company allocates revenue to each non-contingent element based on 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 or third TPE, of selling price. If neither exists the Company uses best estimated selling price, or BESP, for that deliverable. Revenue allocated is then recognized when the four VSOE is based on the price charged when the element is sold separately and is the price actually charged for that deliverable. Establishing VSOE may not ’s price for similar deliverables when sold separately. AcelRx may not When AcelRx is unable to establish the selling price of an element using VSOE or TPE, BESP is utilized in the allocation of the elements of the arrangement. The objective of the BESP is to determine the price at which AcelRx would transact a sale if the element of the license arrangement were sold on a standalone basis. The process for determining BESPs involves management ’s judgment. AcelRx’ process considers multiple factors such as discounted cash flows, estimated direct expenses and other costs and available data, which may one AcelRx recognizes a contingent milestone payment as revenue in its entirety upon our achievement of the milestone. A milestone is substantive if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. Contract and Other Revenue In May 2015, DSUVIA. The DoD Contract provides for the reimbursement of qualified expenses for development, manufacturing, regulatory and clinical costs outlined in the contract in order to submit an NDA to the FDA, including reimbursement for certain personnel and overhead expenses, as defined under the terms of the contract. Revenue under the contract is recognized when the related qualified expenses are incurred. The Company is entitled to reimbursement of overhead costs associated with the study costs incurred under the DoD Contract. The Company estimates this overhead rate by utilizing forecasted expenditures. Final reimbursable overhead expenses are dependent on direct labor and direct reimbursable expenses throughout the life of the DoD Contract, and as a result, may Cost of Goods Sold Under the Amended Agreements with Grünenthal, the Company will sell ZALVISO to Grünenthal at direct cost with minimal markup and will recognize indirect costs as period costs where they are in excess of normal capacity and not third Research and Development Expenses Research and development costs are charged to expense when incurred. Research and development expenses include salaries, employee benefits, including stock-based compensation, consultant fees, laboratory supplies, costs associated with clinical trials and manufacturing, including contract research organization fees, other professional services and allocations of corporate costs. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. Stock-Based Compensation Compensation expense for all share-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2011 2011 2011 The Black-Scholes option pricing model requires inputs such as expected term, expected volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. Estimates of expected life during the years ended December 31, 2016 2015, not December 31, 2017, December 31, 2016 2015, January 1, 2017, 2016 09 not Restructuring Costs The Company's restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the entity notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. Non-Cash Interest Expense on Liability Related to Sale of Future Royalties In September 2015, sold certain royalty and milestone payment rights from the sales of ZALVISO in the European Union by its commercial partner, Grünenthal, pursuant to the Collaboration and License Agreement, dated as of December 16, 2013, $65.0 Grünenthal. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization has been accounted for as a liability that will be amortized using the interest method over the life of the arrangement. In order to determine the amortization of the liability, the Company is required to estimate the total amount of future royalty and milestone payments to be received by PDL and payments the Company is required to make to PDL, up to a capped amount of $195.0 $195.0 $61.2 14%. The Company will record non-cash royalty revenues and non-cash interest expense within its Consolidated Statements of Comprehensive Loss over the term of the PDL agreement. Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive income (loss) and is disclosed in the Consolidated Statements of Comprehensive Loss. For the Company, other comprehensive income (loss) consists of changes in unrealized gains and losses on the Company ’s investments. Income Taxes Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. Net Loss per Share of Common Stock The Company ’s basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share of common stock is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, convertible preferred stock, options to purchase common stock, restricted stock subject to repurchase, warrants to purchase convertible preferred stock and warrants to purchase common stock were considered to be common stock equivalents. In periods with a reported net loss, such common stock equivalents are excluded from the calculation of diluted net loss per share of common stock if their effect is antidilutive. For additional information regarding the net loss per share, see Note 14 Recently Adopted Accounting Pronouncement In March 2016, No. 2016 09, Compensation - Stock Compensation (Topic 718 December 15, 2016, no January 1, 2017, not not In July 2015, No. 2015 11, Inventory (Topic 330 first first No. 2015 11 2017, not Recently Issued Accounting Pronouncements In May 2017, 2017 09, Compensation - Stock Compensation (Topic 718 Scope of Modification Accounting 718. not • The award’s fair value (or calculated value or intrinsic value, if those measurement methods are used), • The award’s vesting conditions, and • The award’s classification as an equity or liability instrument. ASU 2017 09 December 15, 2017 not not 2017 09 In November 2016, No. 2016 18, Statement of Cash Flows (Topic 230 No. 2016 18 2016 18 January 1, 2018, not 2016 18 In August 2016, FASB issued ASU No. 2016 15, Statement of Cash Flows (Topic 230 eight December 15, 2017, not In February 2016, No. 2016 02, Leases (Topic 842 December 15, 2018, not In May 2014, No. 2014 09, Revenue from Contracts with Customers No. 2014 09 may August 2015, No. 2015 14, Revenue from Contracts with Customers (Topic 606 December 15, 2017. No. 2014 09 first 2018. first 2017 No. 2014 09 No. 2014 09 ● ASU No. 2016 08, Revenue from Contracts with Customers (Topic 606 ● ASU No. 2016 10, Identifying Performance Obligations and Licensing (Topic 606 ● ASU No. 2016 11, Revenue Recognition (Topic 605 815 2014 09 2014 16 March 3, 2016 ● ASU No. 2016 12, Revenue from Contracts with Customers (Topic 606 ● ASU No. 2016 20, Revenue from Contracts with Customers (Topic 606 The Company adopted the new standard effective January 1, 2018 not no |
Note 2 - Investments and Fair V
Note 2 - Investments and Fair Value Measurement | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Investments and Fair Value Measurement Disclosure [Text Block] | 2. Investments The Company classifies its marketable securities as available-for-sale and records its investments at fair value. Available-for-sale securities are carried at estimated fair value based on quoted market prices or observable market inputs of almost identical assets, with the unrealized holding gains and losses included in accumulated other comprehensive income. Marketable securities which have maturities beyond one non-current. The table below summarizes the Company ’s cash, cash equivalents and investments (in thousands): As of December 31 , 201 7 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 29,765 $ — $ — $ 29,765 U.S. government agency securities 23,137 — — 23,137 Total cash and cash equivalents 52,902 — — 52,902 Marketable securities : U.S. government agency securities $ 7,567 $ — $ — $ 7,567 Total marketable securities 7,567 — — 7,567 Total cash, cash equivalents and investments $ 60,469 $ — $ — $ 60,469 As of December 31 , 2016 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Cash and cash equivalents: Cash $ 49,833 $ — $ — $ 49,833 U.S. government agency securities 30,474 3 — 30,477 Total cash and cash equivalents 80,307 3 — 80,310 Total cash, cash equivalents and investments $ 80,307 $ 3 $ — $ 80,310 None no December 31, 2017 2016. no December 31, 2017 2016. No no December 31, 2017 2016. As of December 31, 2017 2016, one Fair Value Measurement The Company ’s financial instruments consist of Level II assets and Level III liabilities. For Level II instruments, the Company estimates fair value by utilizing third December 31, 2017 December 31, 2016, June 29, 2011, March 2, 2017, 2014 1 7 two December 31, 2016, June 2012. 11 The following table sets forth the fair value of the Company ’s financial assets and liabilities by level within the fair value hierarchy (in thousands): As of December 31 , 201 7 Fair Value Level I Level II Level III Assets U.S. government agency obligations $ 30,704 $ — $ 30,704 $ — Total assets measured at fair value $ 30,704 $ — $ 30,704 $ — Liabilities Contingent put option liability $ 207 $ — $ — $ 207 Total liabilities measured at fair value $ 207 $ — $ — $ 207 As of December 31 , 2016 Fair Value Level I Level II Level III Assets U.S. government agency obligations $ 30,477 $ — $ 30,477 $ — Total assets measured at fair value $ 30,477 $ — $ 30,477 $ — Liabilities PIPE warrants $ 288 — — $ 288 Contingent put option liability 124 — — 124 Total liabilities measured at fair value $ 412 $ — $ — $ 412 The following table sets forth a summary of the changes in the fair value of the Company ’s Level III financial liabilities for the years ended December 31, 2017 2016 Year Ended December 31, 7 Fair value —beginning of period $ 412 Expiration of fair value of PIPE warrants (288 ) Change in fair value of contingent put option associated with Original Loan Agreement 83 Fair value —end of period $ 207 Year Ended December 31, 6 Fair value —beginning of period $ 1,179 Change in fair value of PIPE warrants (625 ) Change in fair value of contingent put option associated with Original Loan Agreement (142 ) Fair value —end of period $ 412 |
Note 3 - Inventories
Note 3 - Inventories | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 3. Inventories consist of finished goods, raw materials and work in process and are stated at the lower of cost or market and consist of the following (in thousands): As of December 31, 201 7 201 6 Raw materials $ 702 $ 1,126 Work-in-process 254 296 Finished goods — 732 Inventories $ 956 $ 2,154 The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or market approach as that used to value the inventory. During the year ended December 31, 2017, $0.4 |
Note 4 - Property and Equipment
Note 4 - Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and equipment consist of the following (in thousands): As of December 31, 201 7 201 6 Laboratory equipment $ 3,920 $ 3,775 Leasehold improvements 4,469 4,469 Computer equipment and software 241 266 Construction in process 9,703 7,816 Tooling 1,109 1,074 Furniture and fixtures 47 48 19,489 17,448 Less accumulated depreciation and amortization (8,438 ) (6,736 ) Property and equipment, net $ 11,051 $ 10,712 Depreciation and amortization expense was $1.7 $2.1 $2.0 December 31, 2017, 2016 2015, December 31, 2017 2016, $0.3 $1.5 |
Note 5 - U.S. Department of Def
Note 5 - U.S. Department of Defense Contract | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Long-term Contracts or Programs Disclosure [Text Block] | 5. On May 11, 2015, the Clinical and Rehabilitative Medicine Research Program, or CRMRP, of the United States Army Medical Research and Materiel Command, or the USAMRMC, within the U.S. Department of Defense, or the DoD, in which the DoD agreed to provide up to $17.0 DSUVIA (sufentanil sublingual tablet, 30 non-invasive, single-use tablet in a disposable, pre-filled single-dose applicator, or SDA, for the treatment of moderate-to-severe acute pain. Under the terms of the DoD Contract, the DoD has reimbursed the Company for costs incurred for development, manufacturing, regulatory and clinical costs outlined in the DoD Contract, including reimbursement for certain personnel and overhead expenses. The period of performance under the DoD Contract began on May 11, 2015. DoD Contract gives the DoD the option to extend the term of the DoD Contract and provide additional funding for the research. On March 2, 2016, to approve enrollment of additional patients in the SAP302 SAP303 four November 10, 2016 March 9, 2017, SAP302 SAP303 March 9, 2017, 11 February 28, 2018 December 31, 2017, February 28, 2018 February 28, 2018, $0.5 twelve February 28, 2019. DSUVIA is approved by the FDA, the DoD has the option to purchase a certain number of units of commercial product pursuant to the terms of the DoD Contract. Revenue is recognized based on expenses incurred by the Company in conducting research and development activities, including overhead, as set forth in the agreement. Revenue attributable to the work performed under the DoD Contract, recorded as Contract and other revenue in the Consolidated Statements of Comprehensive Loss, was $0.9 $10.9 $4.4 December 31, 2017, 2016 2015, |
Note 6 - Collaboration Agreemen
Note 6 - Collaboration Agreement | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | 6. As described in Note 1 the Company has entered into amendments to the Agreements with Grünenthal related to ZALVISO. In the Amended Agreements, the parties amended the Product supply configurations and packaging of Product components and accessories, and associated pricing therefor, which the Company will manufacture and supply to Grünenthal for the Territory. The parties agreed to increase the pricing of the Product components and accessories in exchange for a reduction of $5.5 $171.5 $166.0 $0.7 $3.7 2016. Amended License Agreement Under the terms of the Amended License Agreement, Grünenthal has the exclusive right to commercialize the Product in the Field in the Territory. The Company retains control of clinical development, while Grünenthal and the Company will be responsible for certain development activities pursuant to a development plan as agreed between the parties. The Company will not $0.7 Product. A CE Mark for ZALVISO was obtained in the fourth 2014 September 2015, 28 April 2016, first The Company received an upfront non-refundable cash payment of $30.0 December 2013, and a milestone payment of $5.0 third 2014, $15.0 September 2015. $194.5 $28.5 $166.0 A portion of the tiered royalty payment, exclusive of the supply and trademark fee payments, will be paid to PDL in connection with the Royalty Monetization. For additional information on the Royalty Monetization with PDL, see Note 8 Amended MSA Under the terms of the Amended MSA, the Company will manufacture and supply the Product for use in the Field for the Territory exclusively for Grünenthal. Grünenthal shall purchase from AcelRx, during the first five or December 16, 2013 December 15, 2018, 100% 80% third third Unless earlier terminated, the Amended MSA continues in effect until the later of the expiration of the obligation of Grünenthal to make royalty and supply and trademark fee payments or the end of any transition period for manufacturing obligations due to the expiration or termination of the Amended License Agreement. The Amended MSA is subject to earlier termination in connection with certain termination events in the Amended License Agreement, in the event the parties mutually agree, by a party in the event of an uncured material breach by the other party or upon the bankruptcy or insolvency of either party. The Company identified the following four 1 2 3 ZALVISO for commercial purposes, and 4 At the time the Amended Agreements were executed, with the exception of the intellectual property license, these obligations remained partially undelivered. Additionally, the Company identified the following three 1 2 ZALVISO demonstration device systems, and 3 The Company considered the provisions of the multiple-element arrangement guidance in determining whether the deliverables outlined above have standalone value and thus should be treated as separate units of accounting. The Company ’s management determined that the license under the original License Agreement had standalone value and represented a separate unit of accounting because the rights conveyed permitted Grünenthal to perform all efforts necessary to commercialize and begin selling the product upon regulatory approval. In addition, Grünenthal has the appropriate development, regulatory and commercial expertise with products similar to the product licensed under the agreement and has the ability to engage third third The Company believes that none , or sufficient TPE of selling price, as none third The Company ’s management determined the best estimate of selling price for the license based on Grünenthal’s estimated future cash flows arising from the arrangement. Embedded in the estimate were significant assumptions regarding regulatory expenses, revenue, including potential customer market for the product and product price, costs to manufacture the product and the discount rate. The Company’s management determined the best estimate of selling price of the research and development services and committee participation based on the nature and timing of the services to be performed and in consideration of personnel and other costs incurred in the delivery of the services. For the discount on manufacturing services, the Company’s management estimated the selling price based on the market level of contract manufacturing margin it could have received if it were engaged to supply products to a customer in a separate transaction, the estimated cost of manufacturing, and the anticipated volume of Grünenthal’s orders over the course of the agreement, to which the discount would apply. For the ZALVISO demonstration devices and the obligation to manufacture and deliver Product, the Company’s management estimated the selling price based on the binding volume of such devices and Products, the estimated cost of manufacturing, and the market level of contract manufacturing margin. BESP of the license, research and development and committee participation services and the discount on manufacturing services were updated at the time the Amended Agreements were executed for purposes of allocating the amended arrangement consideration. The Amended Agreements entitle the Company to receive additional payments upon the achievement of certain development and sales milestones. Based on ASC Topic 605 28, Revenue Recognition — Milestone Method 1 2 The substantive milestone payments will be recognized as revenue in their entirety upon the achievement of each substantive milestone. Based on the criteria noted above, the identified substantive milestones in the original Agreements pertain to post approval product enhancements, expanded market opportunities and manufacturing efficiencies for ZALVISO. Each of these potential achievements is based primarily on the Company’s performance and involves substantive uncertainty as achievement of these milestones requires future research, development and regulatory activities, which are inherently uncertain in nature. The Company determined that the consideration for each milestone was commensurate with the Company’s performance to achieve the milestone, including future research, development, manufacturing and regulatory activities and that the consideration is reasonable relative to all of the other deliverables and payments within the arrangement. Aggregate potential payments for these milestones total $28.5 In addition to substantive milestones, two not ZALVISO in Europe, which the Company’s management deemed to be not $20.0 July 2014, first two $5.0 September 2015, second two $15.0 The Amended Agreements also include milestone payments related to specified net sales targets, totaling $166.0 not 2010 17 not At the time the Amended Agreements were executed, approximately $33.3 $1.7 $35.0 $54.4 $0.7 $3.7 $15.0 September 2015 $13.2 $0.5 $4.4 February 2016, 2029. $0.2 2018. $2.3 $0.5 Below is a summary of revenue recognized under the Amended Agreements during the years ended December 3 1, 2017, 2016 2015 Years Ended December 31, 201 7 201 6 2015 License $ — $ — $ 13,167 Product sales 6,673 5,742 — Joint steering committee, research and development services and demonstration devices 269 688 1,690 Non-cash royalty revenue related to Royalty Monetization (See Note 8) 151 7 — Royalty revenue 50 3 — Total $ 7,143 $ 6,440 $ 14,857 As of December 31, 201 7, $0.4 $3.5 |
Note 7 - Long-term Debt
Note 7 - Long-term Debt | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | 7. Amended Loan and Security Agreement On December 16, 2013, $40.0 three 2013 June 29, 2011. first $15.0 December 16, 2013, second $10.0 June 16, 2014 . The Company used approximately $8.6 first $24.9 December 31, 2014. 176,730 $6.79 On September 24, 2014, No. 1 No. 1 third $15.0 March 15, 2015 August 1, 2015, not August 1, 2015 not third On September 18, 2015, No. 2, No. 2, Lenders. Amendment No. 2 October 1, 2015 March 31, 2016, September 30, 2016 third 2015 September 30, 2016. October 1, 2017. No. 2, 176,730 $6.79 $3.88 On September 30, 2016, No. 3 ith the Lenders. Among other things, Amendment No. 3 October 1, 2016 April 1, 2017. No. 3, 176,730 $3.88 $3.07 On March 2, 2017, the Company borrowed the first $20.5 March 2, 2017, first $1.7 October 1, 2017. 9.55% 3.50%, 9.55%. October 1, 2017 March 1, 2020. 6.5% If the Company prepays the loans under the Amended Loan Agreement prior to the maturity date, it will pay Hercules a prepayment charge, based on a percentage of the then outstanding principal balance, equal to 3% March 2, 2018, 2% March 2, 2018, March 2, 2019, 1% March 2, 2019. The Amended Loan Agreement includes customary affirmative and restrictive covenants, but does not ’ security interest or in the value of the collateral, and events relating to bankruptcy or insolvency. Upon the occurrence of an event of default, a default interest rate of an additional 5% may may Upon an event of default, including a change of control, Hercules has the option to accelerate repayment of the Amended Loan Agreement, including payment of any applicable prepayment charges. This option is considered a contingent put option liability, as the holder of the loan has the ability to exercise the option in the event of default, and is considered an embedded derivative, which must be valued and separately accounted for in the Company’s financial statements. As the Original Loan Agreement entered into on December 16, 2013 $32 December 31, 2017 2016, $0.2 $0.1 two other income (expense), net in the Consolidated Statements of Comprehensive Loss. The Company performed an analysis of Amendments No. 2 No. 3 No. 2 No. 3 The accrued balance due under the Amended Loan Agreement was $19.1 December 31, 2017 $21.5 December 31, 2016. $3.3 December 31, 2017 $2.8 $3.0 December 31, 2016 2015, Future Payments on Long-Term Debt The following table summarizes our outstanding future payments associated with the Company ’s long-term debt as of December 31, 2017 20 18 $ 9,350 2019 9,350 20 20 3,704 Total payments 22,404 Less amount representing interest (2,420 ) Notes payable, gross 19,984 Unamortized portion of final payment (741 ) Unamortized discount on notes payable (147 ) Long-term debt 19,096 Less current portion of notes payable, including unamortized discount (7,727 ) Long-term debt, current portion $ 11,369 |
Note 8 - Liability Related to S
Note 8 - Liability Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Liability Related To Sale Of Future Royalties Disclosure [Text Block] | 8. On September 18, 2015, $65.0 million, subject to a capped amount of $195.0 75% 80% first four $35.6 80% $44.5 25% 20% first four 100% $43.5 $15.0 The Company and ARPI LLC continue to retain certain duties and obligations under the Amended License Agreement. These include the collection of the royalty and milestones amounts due and enforcement of related provisions under the Amended License Agreement, among others. In addition, the Company must prepare a quarterly distribution report relating to the Amended License Agreement, containing among other items, the amount of royalty and milestone payments received, reimbursable expenses and set-offs. The Company and ARPI LLC must also provide PDL with notice of certain communications, events or actions with respect to the Amended License Agreement and infringement of any underlying intellectual property. The Company has significant continuing involvement in the Royalty Monetization primarily due to an obligation to act as the intermediary for the supply of ZALVISO to Grünenthal. Under the relevant accounting guidance, because of its significant continuing involvement, the Royalty Monetization has been accounted for as a liability that will be amortized using the interest method over the life of the arrangement. In order to determine the amortization of the liability, the Company is required to estimate the total amount of future royalty and milestone payments to be received by PDL and payments the Company is required to make to PDL, up to a capped amount of $195.0 $195.0 $61.2 14%. The Company will periodically assess the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments are greater or less than our initial estimates or the timing of such payments is materially different than our original estimates, the Company will prospectively adjust the amortization of the liability and the interest rate. The following table shows the activity within the liability account during the year ended December 31, 201 7 Year ended December 31, 7 Period from inception to 7 Liability related to sale of future royalties — beginning balance $ 72,987 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (120 ) (127 ) Non-cash interest expense recognized 10,721 22,531 Liability related to sale of future royalties as of December 31, 2017 83,588 83,588 Less: current portion (604 ) (604 ) Liability related to sale of future royalties — net of current portion $ 82,984 $ 82,984 Estimated non-cash royalty revenue of $31.0 fourth 2017 not not As royalties are remitted to PDL from ARPI LLC, as described in Note 1 |
Note 9 - Warrants
Note 9 - Warrants | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Warrants Disclosure [Text Block] | 9. Amended and Restated Loan Agreement Warrants In connection with the Original Loan Agreement, executed in December 2013, 176,730 $6.79 connection with Amendment No. 2 $6.79 $3.88 No. 3 $3.88 $3.07 may five $1.1 $6.79, $9.67, five 1.55%, 71% 0% $0.1 September 2015 $45.0 September 2016 As of December 31, 2017, 176,730 not December 2018. 2012 In connection with the Private Placement, completed in June 2012, 2,630,103 $3.40 ’s common stock on May 29, 2012, six five 50% may 2 Upon execution of the Purchase Agreement, the fair value of the PIPE warrants was estimated to be $5.8 hich was recorded as a liability. The change in fair value for the years ended December 31, 2017, 2016 2015, $0.3 $0.6 $2.1 During the year ended December 31, 2017, 512,456 December 31, 2015, 847,058 527,101 |
Note 10 - Commitments and Conti
Note 10 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 10. Contingencies Operating Leases In December 2011, 13,787 301 April 2012. December 2011, In May 2014, was extended for a period of twenty 20 twenty-two 22 January 31, 2018, 12,106 351 42 August 1, 2014, January 31, 2018. On October 2, 2015, approximately 11,871 26 December 1, 2015. first two $2.05 $0.3 December 31, 2017 $25.0 December 31, 2018. On June 14, 2017, Company entered into a second 25,893 301 351 seventy-two 72 February 1, 2018 January 31, 2024, Pursuant to the Lease Amendment, the Company will pay on a monthly basis annual rent of approximately $1.2 12 February 1 st first two not Rent expense was $0.6 $0.3 $0.6 December 31, 2017, 2016 2015, Future minimum payments under the Lease as of December 31, 2017, Year Ending December 31: 201 8 $ 959 2019 1,231 2020 1,268 2021 1,305 2022 1,345 Thereafter 1,501 Total minimum payments $ 7,609 Litigation From time to time the Company may not |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 11. ’ Equity Common Stock 201 6 ATM Agreement On June 21, 2016, SM 2016 may $40.0 December 31, 2017, 5.4 2016 $15.7 $0.5 Stock Plans 2006 In August 2006, shed the 2006 342 February 2008, 375 2006 November 2009, 1.4 2006 2006 10% not 110% no may 2006 2011 In January 2011, Board of Directors adopted, and the Company’s stockholders approved, the 2011 2011 2006 2011 February 10, 2011. February 10, 2011, no may 2006 2006 2006 52 2006 2011 The initial aggregate number of shares of the Company ’s common stock that may 2011 1.9 52 2006 1.8 2011 January 1st January 1, 2012 January 1, 2020, 4% December 31 not 10 2011 four 10 not 2011 Additionally, in January 2011, Board of Directors adopted, and the Company’s stockholders approved, the 2011 Initially, 250 ’s common stock were authorized for issuance under the ESPP pursuant to purchase rights granted to the Company’s employees or to employees of any of its designated affiliates. The number of shares of the Company’s common stock reserved for issuance will automatically increase on January 1st January 1, 2012 January 1, 2020, 1 2% December 31 2 not As of December 31, 2017, 94,893 1,041,249 2017, 2016 2015 $2.59, $2.98 $4.48 |
Note 12 - Stock-based Compensat
Note 12 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 12. The Company recorded total stock-based compensation expense for stock options, stock awards and the ESPP as follows (in thousands): December 31, 7 December 31, 6 December 31, 5 Cost of goods sold $ 324 $ 302 $ 67 Research and development 1,901 2,308 2,587 General and administrative 2,069 1,869 2,356 Total $ 4,294 $ 4,479 $ 5,010 The following table summarizes option activity under the 2011 2006 Number of Stock Options Weighted- Average Weighted- Average Aggregate Intrinsic (in thousands) December 31, 2016 6,307,756 $ 5.00 Granted 3,007,155 2.99 Forfeited (438,519 ) 4.28 Expired (351,922 ) 7.31 Exercised (69,372 ) 1.52 December 31, 2017 8,455,098 $ 4.25 7.1 $ 13 Vested and exercisable options —December 31, 2017 4,529,174 $ 5.11 5.56 $ 13 Vested and expected to vest —December 31, 2017 8,455,098 $ 4.25 7.1 $ 13 As of December 31, 2017, 2,368,992 2011 January 2018, 2,035,966 2011 Additional information regarding the Company ’s stock options outstanding and vested and exercisable as of December 31, 2017 Options Outstanding Options Vested and Exercisable Exercise Prices Number of Stock Options Weighted-Average Remaining Weighted-Average Exercise Price per Shares Subject Weighted-Average Exercise Price per $1.20 - $2. 30 105,900 8.4 $ 2.13 38,400 $ 1.84 $2. 40 - $3.77 5,592,633 7.7 $ 3.10 1,948,300 $ 3.17 $ 3.92 - $6.60 2,060,565 5.7 $ 5.45 1,880,190 $ 5.36 $8.18 - $10.55 696,000 6.2 $ 10.28 662,284 $ 10.28 8,455,098 7.1 $ 4.25 4,529,174 $ 5.11 The weighted average grant-date fair value of options granted during the years ended December 31, 2017, 2016 2015 $1.91, $2.24 $2.69 December 31, 2017, $7.1 2.6 December 31, 2017, 2016 2015 $3.5 $3.9 $5.4 December 31, 2017 $40 no December 31, 2016, December 31, 2015 $1.3 The Company used the following assumptions to calculate the fair value of each employee stock option: Year Ended December 31, 201 7 201 6 201 5 Expected term (in years) 5.70 5.25 - 6.25 5.25 - 6.25 Risk-free interest rate 1.82% - 2.09% 1.24% - 1.47% 1.35% - 1.82% Expected volatility 73% 80% 72% Expected dividend rate 0% 0% 0% |
Note 13 - Restructuring Costs
Note 13 - Restructuring Costs | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Restructuring and Related Activities Disclosure [Text Block] | 13. On March 19, 2015, ZALVISO, and continuing development of DSUVIA, implemented a cost reduction plan. The cost reduction plan reduced the Company’s workforce by 19 36% first 2015. $0.8 December 31, 2015. December 31, 2015. |
Note 14 - Net Loss Per Share of
Note 14 - Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 14. The Company ’s basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share of common stock is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, options to purchase common stock and warrants to purchase common stock were considered to be common stock equivalents. In periods with a reported net loss, common stock equivalents are excluded from the calculation of diluted net loss per share of common stock if their effect is antidilutive. The PIPE warrants expired during the year ended December 31, 2017. During the year ended December 31, 2016, December 31, 2016. December 31, 2015, December 31, 2015, December 31, 2014. December 31, 2015. The following table is a reconciliation of the numerators and denominators used in the calculation of basic and diluted net loss per share computations for the years ended December 31, 2017, 2016 2015: Years Ended December 31, 201 7 201 6 201 5 (in thousands, except share and per share amounts) Numerator: Net loss used to compute net loss per share Basic $ (51,508 ) $ (43,157 ) $ (24,399 ) Adjustments for change in fair value of warrant liability — — (2,120 ) Diluted $ (51,508 ) $ (43,157 ) $ (26,519 ) Denominator: Weighted average shares outstanding used to compute net loss per share: Basic 46,883,535 45,313,118 44,300,099 Dilutive effect of warrants — — 168,341 Diluted 46,883,535 45,313,118 44,468,440 Net loss per share —basic $ (1.10 ) $ (0.95 ) $ (0.55 ) Net loss per share —diluted $ (1.10 ) $ (0.95 ) $ (0.60 ) The following outstanding shares of common stock equivalents were excluded from the computation of diluted net loss per share of common stock for the periods presented because including them would have been antidilutive: Year Ended December 31, 201 7 201 6 201 5 ESPP and stock options to purchase common stock 8,767,783 6,395,879 4,699,121 Convertible debt into common stock — 553,763 553,763 Common stock warrants 176,730 692,611 180,155 |
Note 15 - Accrued Liabilities
Note 15 - Accrued Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 15. Accrued liabilities consist of the following (in thousands): December 31, 201 7 201 6 Accrued compensation and employee benefits $ 2,190 $ 2,556 Inventory and other contract manufacturing accruals 511 1,218 Other accrued liabilities 842 821 Total accrued liabilities $ 3,543 $ 4,595 |
Note 16 - 401(k) Plan
Note 16 - 401(k) Plan | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Pension and Other Postretirement Benefits Disclosure [Text Block] | 16. 401 The Company sponsors a 401 401 401 4% contributions were $0.3 $0.3 $0.3 December 31, 2017, 2016 2015, |
Note 17 - Related Party Transac
Note 17 - Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Related Party Transactions Disclosure [Text Block] | 17. Stephen Hoffman is a Senior Advisor to PDL and a member of the Company's Board of Directors, or the Board. The Board was aware of Dr. Hoffman ’s status as an interested party in the Royalty Monetization and Dr. Hoffman recused himself from all deliberations and actions taken by the Board with respect to the Royalty Monetization. Dr. Hoffman’s consulting compensation from PDL is composed, in part, of a success fee which is formula driven based on a minimum dollar value of deals and the total dollar value of the deals, his relative contribution to each of the concluded deals, and the total dollar value deployed in 2015. December 31, 2015 $0.3 8 |
Note 18 - Income Taxes
Note 18 - Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 18. The Company recorded a benefit for income taxes of $0.7 December 31, 2017, $34.0 December 31, 2016. $0.8 December 31, 2015. The provision (benefit) for income taxes consisted of the following (in thousands): December 31, 7 December 31, 6 Current: Federal $ (702 ) $ (39 ) State 1 6 Total Current (701 ) (33 ) Deferred: Federal — (1 ) State — — Total D eferred — (1 ) Provision (benefit) for income taxes $ (701 ) $ (34 ) Net deferred tax assets as of D ecember 31, 2017 2016 December 31, 7 December 31, 6 Deferred tax assets: Accruals and other $ 2,717 $ 3,746 Research credits 6,530 5,670 Net operating loss carryforward 31,064 36,224 Section 59(e) R&D expenditures 12,156 16,782 Deferred revenue 18,384 24,836 AMT credit — 703 Total deferred tax assets 70,851 87,961 Valuation allowance (70,851 ) (87,961 ) Net deferred tax assets $ — $ — Reconciliations of the statutory federal income tax to the Company ’s effective tax during the years ended December 31, 2017, 2016 2015 Year Ended December 31, 201 7 2016 2015 Tax at statutory federal rate $ (17,751 ) $ (14,685 ) $ (8,037 ) State tax —net of federal benefit 350 (73 ) 2,853 PIPE Warrant liability (70 ) (260 ) (726 ) General Business credits (316 ) (360 ) (455 ) Stock Options 42 1,115 1,559 Other 51 33 73 Change in valuation allowance (17,110 ) 14,196 5,493 Tax Reform – Tax Rate Change 34,103 — — Provision for income taxes $ (701 ) $ (34 ) $ 760 ASC 740 not.” decreased by $17.1 December 31, 2017 $14.2 $5.5 2016 2015, As of December 31, 2017, $115.6 2029. December 31, 2017, $97.2 2028. As of December 31, 2017, $0.7 which is now refundable under the tax reform enacted on December 22, 2017 As of December 31, 2017, $5.9 2026. December 31, 2017, $3.6 The Company has adopted ASU 2016 09 December 31, 2017. $2.9 $2.0 Under Section 382 1986, 50% three may December 31, 2013, two first 2006 $1.4 $26,000 second July 2013 not 2013, may On December 22, 2017, 2017 35% 21% periods beginning after December 31, 2017, one December 31, 2017. $0.7 fourth 2017, $0.7 No not Uncertain Tax Positions A reconciliation of the beginning and ending balances of the unrecognized tax benefits during t he years ended December 31, 2017, 2016 2015 Year Ended December 31, 2017 2016 2015 Unrecognized benefit —beginning of period $ 2,162 $ 1,939 $ 1,667 Gross decreases —prior period tax positions — — — Gross increases —current period tax positions 203 223 272 Unrecognized benefit —end of period $ 2,365 $ 2,162 $ 1,939 The entire amount of the unrecognized tax benefits would not ’s effective tax rate if recognized. Accrued interest and penalties related to unrecognized tax benefits are classified as income tax expense and were immaterial. The Company files income tax returns in the United States and in California. The tax years 2005 2017 not not 12 |
Note 19 - Unaudited Quarterly F
Note 19 - Unaudited Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2017 | |
Notes to Financial Statements | |
Quarterly Financial Information [Text Block] | 19 . Unaudited Quarterly Financial Data The following table sets forth certain unaudited quarterly financial data for the eight December 31, 2017. not 201 7 201 6 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Revenues $ 3,109 $ 2,659 $ 1,487 $ 740 $ 3,025 $ 4,531 $ 3,366 $ 6,435 Operating costs and expenses $ 15,182 $ 12,600 $ 10,348 $ 8,547 $ 11,547 $ 12,853 $ 11,341 $ 13,573 Net income / (loss) $ (15,551 ) $ (13,059 ) $ (13,013 ) $ (9,885 ) $ (10,981 ) $ (11,092 ) $ (11,402 ) $ ( 9,682 ) Net income / (loss) per share (basic) $ (0.34 ) $ (0.29 ) $ (0.28 ) $ (0.20 ) $ (0.24 ) $ (0.24 ) $ (0.25 ) $ (0.21 ) Net income / (loss) per share (diluted) $ (0.34 ) $ (0.29 ) $ (0.28 ) $ (0.20 ) $ (0.25 ) $ (0.24 ) $ (0.25 ) $ (0.21 ) |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Business Description of Entity [Policy Text Block] | The Company AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on July 13, 2005 January 2006, ’s operations are based in Redwood City, California. AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain. AcelRx’s lead product candidate, DSUVIA ™ ® not may DSUVIA DSUVIA, is a 30 was initially developed at the request of the U.S. Department of Defense as a replacement for injections of morphine on the battlefield. In addition to the military application, AcelRx is developing DSUVIA for the treatment of patients suffering from moderate-to-severe acute pain in multiple settings, such as emergency room patients; patients who are recovering from short-stay or ambulatory surgery and do not 3 February 2017 October 12, 2017, two 50 Type A post-action meeting with the FDA on January 26, 2018 second 2018, March 2017, 30 04 first 2018 . ZALVISO ZALVISO delivers 15 Liechtenstein and is in late-stage development in the U.S. The Company had initially submitted to the FDA an NDA seeking approval for ZALVISO in September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 second 2018. On December 16, 2013, nenthal GmbH, or Grünenthal, entered into a Collaboration and License Agreement, or the License Agreement, which was amended effective July 17, 2015 September 20, 2016, September 2015, 28 December 16, 2013, July 22, 2015, July 17, 2015, Grü nenthal has begun its commercial launch of ZALVISO in the European Union. Royalty revenues and non-cash royalty revenues from the commercial sales of ZALVISO in the EU are expected to be minimal for 2018 . The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although ZALVISO has been approved for sale in the EU, the Company sold the majority of the royalty rights and certain commercial sales milestones it is entitled to receive under the Amended License Agreement with Grünenthal to PDL BioPharma, Inc., or PDL. As a result, the Company expects to continue to incur operating losses and negative cash flows. When we refer to "we," "our," "us," the "Company" or "AcelRx" in this document, we mean the current Delaware corporation, or AcelRx Pharmaceuticals, Inc., and its predecessor, as well as its consolidated subsidiary. |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the Consolidated Financial Statements and the accompanying notes. Actual results could differ from those estimates. |
Reclassification, Policy [Policy Text Block] | Reclassifications Certain prior year amounts in the Consolidated Financial Statements have been reclassified to conform to the current year's presentation. In particular, the amounts reported in the Consolidated Statements of Cash Flows as “Amortization of premium/discount on investments, net” have been reclassified to “Other” for the years ended December 31, 2016 December 31, 2015. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The Consolidated Financial Statements include the accounts of the Company and its wholly owned subsidiary, ARPI LLC, which was formed in September 2015 Grünenthal, pursuant to the Amended License Agreement, or the Royalty Monetization. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note 8 |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the Consolidated Financial Statements and accompanying notes. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not |
Cash, Cash Equivalents, and Marketable Securities [Policy Text Block] | Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments with an original maturity (at date of purchase) of three All marketable securities are classified as available-for-sale and consist of U.S. government sponsored enterprise debt securities. These securities are carried at estimated fair value, which is based on quoted market prices or observable market inputs of almost identical assets, with unrealized gains and losses included in accumulated other comprehensive income (loss). The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income or expense. The cost of securities sold is based on specific identification. The Company ’s investments are subject to a periodic impairment review for other-than-temporary declines in fair value. The Company’s review includes the consideration of the cause of the impairment including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in the market value. When the Company determines that the decline in fair value of an investment is below its accounting basis and this decline is other-than-temporary, it reduces the carrying value of the security it holds and records a loss in the amount of such decline. |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company measures and reports its cash equivalents, investments and financial liabilities at fair value. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three Level I —Unadjusted quoted prices in active markets for identical assets or liabilities; Level II —Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not Level III —Unobservable inputs that are supported by little or no The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. |
Segment Reporting, Policy [Policy Text Block] | Segment Information The Company operates in a single segment, the development and commercialization of product candidates for the treatment of pain. The Company ’s contract revenue relates to sales in the United States. The Company’s collaboration revenue relates to the Amended License Agreement with Grünenthal to commercialize ZALVISO in the countries of the European Union, Switzerland, Liechtenstein, Iceland, Norway and Australia. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Risk The Company invests cash that is currently not s. The Company relies on a single third ZALVISO, and various sole-source third To date, the Company has had only two two 100% December 31, 2017, 2016 2015. 79% December 31, 2017, 71% 84% December 31, 2016 2015, The Company has not accounts receivable and believes that the entire accounts receivable balance as of December 31, 2017 |
Receivables, Policy [Policy Text Block] | Accounts Receivable, Net The Company has receivables from its collaboration partner and the U.S. Department of Defense, or DoD. To date, the Company has not ’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in bad debt. |
Inventory, Policy [Policy Text Block] | Inventories Inventories are valued at the lower of cost and net realizable value. Cost is determined using the first first third Indirect overhead costs in excess of normal capacity are recorded as period costs in the period incurred. The Company's policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or market approach as that used to value the inventory. During the year ended December 31, 2017, $0.4 Because selling prices to Grünenthal are set to recover only direct costs with minimal mark up, all inventories are carried at net realizable value. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally three five Expenditures for repairs and maintenance, which do not |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets The Company periodically assesses the impairment of long-lived assets and, if indicators of asset impairment exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through an analysis of the undiscounted future expected operating cash flows. If impairment is indicated, the Company records the amount of such impairment for the excess of the carrying value of the asset over its estimated fair value. For example, purchased equipment and manufacturing-related facility improvements the Company has made at Patheon ’s facility in Ohio, are utilized for continued research and development, commercial manufacturing of ZALVISO for Grünenthal and potential commercialization of its other product candidates. If the Company does not may no September 30, 2015, $0.5 December 31, 2015, December 31, 2017, not |
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy [Policy Text Block] | Restricted Cash Under the Company ’s facility lease and corporate credit card agreements, the Company is required to maintain letters of credit as security for performance under these agreements. The letters of credit are secured by certificates of deposit in amounts equal to the letters of credit, which are classified as restricted cash on the Consolidated Balance Sheets. |
Debt, Policy [Policy Text Block] | Debt Issuance Costs Debt issuance costs, which are included in long-term debt, net of current portion, are amortized as interest expense over the contractual terms of the related credit facilities. |
Contingent Put Option, Policy [Policy Text Block] | Contingent put option The contingent put option associated with the Company ’s loan and security agreement with Hercules Technology II, L.P. and Hercules Technology Growth Capital, Inc., collectively referred to as the Lenders, is recorded as a liability. Changes in the fair value of the contingent put option are recognized as interest income and other income (expense), net in the Consolidated Statements of Comprehensive Loss. For additional information regarding the contingent put option, see Note 7 |
Warrants, Policy [Policy Text Block] | Warrants Warrants issued in connection with the Company ’s Private Placement, completed in June 2012, 9 |
Revenue Recognition, Policy [Policy Text Block] | Revenue Recognition The Company recognizes revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the fee is fixed or determinable; and collectability is reasonably assured. Collaboration Revenue Collaboration revenue, which is earned under license agreements with third may AcelRx accounts for multiple-element arrangements in accordance with ASC Topic 605 25, Revenue Recognition—Multiple-Element Arrangements 605 25. not For revenue agreements with multiple-element arrangements, such as the collaboration and license agreement with Grünenthal, the Company allocates revenue to each non-contingent element based on 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 or third TPE, of selling price. If neither exists the Company uses best estimated selling price, or BESP, for that deliverable. Revenue allocated is then recognized when the four VSOE is based on the price charged when the element is sold separately and is the price actually charged for that deliverable. Establishing VSOE may not ’s price for similar deliverables when sold separately. AcelRx may not When AcelRx is unable to establish the selling price of an element using VSOE or TPE, BESP is utilized in the allocation of the elements of the arrangement. The objective of the BESP is to determine the price at which AcelRx would transact a sale if the element of the license arrangement were sold on a standalone basis. The process for determining BESPs involves management ’s judgment. AcelRx’ process considers multiple factors such as discounted cash flows, estimated direct expenses and other costs and available data, which may one AcelRx recognizes a contingent milestone payment as revenue in its entirety upon our achievement of the milestone. A milestone is substantive if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. Contract and Other Revenue In May 2015, DSUVIA. The DoD Contract provides for the reimbursement of qualified expenses for development, manufacturing, regulatory and clinical costs outlined in the contract in order to submit an NDA to the FDA, including reimbursement for certain personnel and overhead expenses, as defined under the terms of the contract. Revenue under the contract is recognized when the related qualified expenses are incurred. The Company is entitled to reimbursement of overhead costs associated with the study costs incurred under the DoD Contract. The Company estimates this overhead rate by utilizing forecasted expenditures. Final reimbursable overhead expenses are dependent on direct labor and direct reimbursable expenses throughout the life of the DoD Contract, and as a result, may |
Cost of Sales, Policy [Policy Text Block] | Cost of Goods Sold Under the Amended Agreements with Grünenthal, the Company will sell ZALVISO to Grünenthal at direct cost with minimal markup and will recognize indirect costs as period costs where they are in excess of normal capacity and not third |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses Research and development costs are charged to expense when incurred. Research and development expenses include salaries, employee benefits, including stock-based compensation, consultant fees, laboratory supplies, costs associated with clinical trials and manufacturing, including contract research organization fees, other professional services and allocations of corporate costs. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. |
Share-based Compensation, Option and Incentive Plans, Director Policy [Policy Text Block] | Stock-Based Compensation Compensation expense for all share-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2011 2011 2011 The Black-Scholes option pricing model requires inputs such as expected term, expected volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. Estimates of expected life during the years ended December 31, 2016 2015, not December 31, 2017, December 31, 2016 2015, January 1, 2017, 2016 09 not |
Costs Associated with Exit or Disposal Activities or Restructurings, Policy [Policy Text Block] | Restructuring Costs The Company's restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the entity notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. |
Interest Expense, Policy [Policy Text Block] | Non-Cash Interest Expense on Liability Related to Sale of Future Royalties In September 2015, sold certain royalty and milestone payment rights from the sales of ZALVISO in the European Union by its commercial partner, Grünenthal, pursuant to the Collaboration and License Agreement, dated as of December 16, 2013, $65.0 Grünenthal. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization has been accounted for as a liability that will be amortized using the interest method over the life of the arrangement. In order to determine the amortization of the liability, the Company is required to estimate the total amount of future royalty and milestone payments to be received by PDL and payments the Company is required to make to PDL, up to a capped amount of $195.0 $195.0 $61.2 14%. The Company will record non-cash royalty revenues and non-cash interest expense within its Consolidated Statements of Comprehensive Loss over the term of the PDL agreement. |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive income (loss) and is disclosed in the Consolidated Statements of Comprehensive Loss. For the Company, other comprehensive income (loss) consists of changes in unrealized gains and losses on the Company ’s investments. |
Income Tax, Policy [Policy Text Block] | Income Taxes Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. |
Earnings Per Share, Policy [Policy Text Block] | Net Loss per Share of Common Stock The Company ’s basic net loss per share of common stock is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share of common stock is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, convertible preferred stock, options to purchase common stock, restricted stock subject to repurchase, warrants to purchase convertible preferred stock and warrants to purchase common stock were considered to be common stock equivalents. In periods with a reported net loss, such common stock equivalents are excluded from the calculation of diluted net loss per share of common stock if their effect is antidilutive. For additional information regarding the net loss per share, see Note 14 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncement In March 2016, No. 2016 09, Compensation - Stock Compensation (Topic 718 December 15, 2016, no January 1, 2017, not not In July 2015, No. 2015 11, Inventory (Topic 330 first first No. 2015 11 2017, not Recently Issued Accounting Pronouncements In May 2017, 2017 09, Compensation - Stock Compensation (Topic 718 Scope of Modification Accounting 718. not • The award’s fair value (or calculated value or intrinsic value, if those measurement methods are used), • The award’s vesting conditions, and • The award’s classification as an equity or liability instrument. ASU 2017 09 December 15, 2017 not not 2017 09 In November 2016, No. 2016 18, Statement of Cash Flows (Topic 230 No. 2016 18 2016 18 January 1, 2018, not 2016 18 In August 2016, FASB issued ASU No. 2016 15, Statement of Cash Flows (Topic 230 eight December 15, 2017, not In February 2016, No. 2016 02, Leases (Topic 842 December 15, 2018, not In May 2014, No. 2014 09, Revenue from Contracts with Customers No. 2014 09 may August 2015, No. 2015 14, Revenue from Contracts with Customers (Topic 606 December 15, 2017. No. 2014 09 first 2018. first 2017 No. 2014 09 No. 2014 09 ● ASU No. 2016 08, Revenue from Contracts with Customers (Topic 606 ● ASU No. 2016 10, Identifying Performance Obligations and Licensing (Topic 606 ● ASU No. 2016 11, Revenue Recognition (Topic 605 815 2014 09 2014 16 March 3, 2016 ● ASU No. 2016 12, Revenue from Contracts with Customers (Topic 606 ● ASU No. 2016 20, Revenue from Contracts with Customers (Topic 606 The Company adopted the new standard effective January 1, 2018 not no |
Note 2 - Investments and Fair27
Note 2 - Investments and Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Cash, Cash Equivalents and Investments [Table Text Block] | As of December 31 , 201 7 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 29,765 $ — $ — $ 29,765 U.S. government agency securities 23,137 — — 23,137 Total cash and cash equivalents 52,902 — — 52,902 Marketable securities : U.S. government agency securities $ 7,567 $ — $ — $ 7,567 Total marketable securities 7,567 — — 7,567 Total cash, cash equivalents and investments $ 60,469 $ — $ — $ 60,469 As of December 31 , 2016 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Cash and cash equivalents: Cash $ 49,833 $ — $ — $ 49,833 U.S. government agency securities 30,474 3 — 30,477 Total cash and cash equivalents 80,307 3 — 80,310 Total cash, cash equivalents and investments $ 80,307 $ 3 $ — $ 80,310 |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | As of December 31 , 201 7 Fair Value Level I Level II Level III Assets U.S. government agency obligations $ 30,704 $ — $ 30,704 $ — Total assets measured at fair value $ 30,704 $ — $ 30,704 $ — Liabilities Contingent put option liability $ 207 $ — $ — $ 207 Total liabilities measured at fair value $ 207 $ — $ — $ 207 As of December 31 , 2016 Fair Value Level I Level II Level III Assets U.S. government agency obligations $ 30,477 $ — $ 30,477 $ — Total assets measured at fair value $ 30,477 $ — $ 30,477 $ — Liabilities PIPE warrants $ 288 — — $ 288 Contingent put option liability 124 — — 124 Total liabilities measured at fair value $ 412 $ — $ — $ 412 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Year Ended December 31, 7 Fair value —beginning of period $ 412 Expiration of fair value of PIPE warrants (288 ) Change in fair value of contingent put option associated with Original Loan Agreement 83 Fair value —end of period $ 207 Year Ended December 31, 6 Fair value —beginning of period $ 1,179 Change in fair value of PIPE warrants (625 ) Change in fair value of contingent put option associated with Original Loan Agreement (142 ) Fair value —end of period $ 412 |
Note 3 - Inventories (Tables)
Note 3 - Inventories (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | As of December 31, 201 7 201 6 Raw materials $ 702 $ 1,126 Work-in-process 254 296 Finished goods — 732 Inventories $ 956 $ 2,154 |
Note 4 - Property and Equipme29
Note 4 - Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | As of December 31, 201 7 201 6 Laboratory equipment $ 3,920 $ 3,775 Leasehold improvements 4,469 4,469 Computer equipment and software 241 266 Construction in process 9,703 7,816 Tooling 1,109 1,074 Furniture and fixtures 47 48 19,489 17,448 Less accumulated depreciation and amortization (8,438 ) (6,736 ) Property and equipment, net $ 11,051 $ 10,712 |
Note 6 - Collaboration Agreem30
Note 6 - Collaboration Agreement (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Revenue Recognition Amended Agreements [Table Text Block] | Years Ended December 31, 201 7 201 6 2015 License $ — $ — $ 13,167 Product sales 6,673 5,742 — Joint steering committee, research and development services and demonstration devices 269 688 1,690 Non-cash royalty revenue related to Royalty Monetization (See Note 8) 151 7 — Royalty revenue 50 3 — Total $ 7,143 $ 6,440 $ 14,857 |
Note 7 - Long-term Debt (Tables
Note 7 - Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Maturities of Long-term Debt [Table Text Block] | 20 18 $ 9,350 2019 9,350 20 20 3,704 Total payments 22,404 Less amount representing interest (2,420 ) Notes payable, gross 19,984 Unamortized portion of final payment (741 ) Unamortized discount on notes payable (147 ) Long-term debt 19,096 Less current portion of notes payable, including unamortized discount (7,727 ) Long-term debt, current portion $ 11,369 |
Note 8 - Liability Related to32
Note 8 - Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Other Liabilities [Table Text Block] | Year ended December 31, 7 Period from inception to 7 Liability related to sale of future royalties — beginning balance $ 72,987 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (120 ) (127 ) Non-cash interest expense recognized 10,721 22,531 Liability related to sale of future royalties as of December 31, 2017 83,588 83,588 Less: current portion (604 ) (604 ) Liability related to sale of future royalties — net of current portion $ 82,984 $ 82,984 |
Note 10 - Commitments and Con33
Note 10 - Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Year Ending December 31: 201 8 $ 959 2019 1,231 2020 1,268 2021 1,305 2022 1,345 Thereafter 1,501 Total minimum payments $ 7,609 |
Note 12 - Stock-based Compens34
Note 12 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | December 31, 7 December 31, 6 December 31, 5 Cost of goods sold $ 324 $ 302 $ 67 Research and development 1,901 2,308 2,587 General and administrative 2,069 1,869 2,356 Total $ 4,294 $ 4,479 $ 5,010 |
Share-based Compensation, Stock Options, Activity [Table Text Block] | Number of Stock Options Weighted- Average Weighted- Average Aggregate Intrinsic (in thousands) December 31, 2016 6,307,756 $ 5.00 Granted 3,007,155 2.99 Forfeited (438,519 ) 4.28 Expired (351,922 ) 7.31 Exercised (69,372 ) 1.52 December 31, 2017 8,455,098 $ 4.25 7.1 $ 13 Vested and exercisable options —December 31, 2017 4,529,174 $ 5.11 5.56 $ 13 Vested and expected to vest —December 31, 2017 8,455,098 $ 4.25 7.1 $ 13 |
Schedule of Share-based Compensation, Stock Options Outstanding and Exercisable Activity [Table Text Block] | Options Outstanding Options Vested and Exercisable Exercise Prices Number of Stock Options Weighted-Average Remaining Weighted-Average Exercise Price per Shares Subject Weighted-Average Exercise Price per $1.20 - $2. 30 105,900 8.4 $ 2.13 38,400 $ 1.84 $2. 40 - $3.77 5,592,633 7.7 $ 3.10 1,948,300 $ 3.17 $ 3.92 - $6.60 2,060,565 5.7 $ 5.45 1,880,190 $ 5.36 $8.18 - $10.55 696,000 6.2 $ 10.28 662,284 $ 10.28 8,455,098 7.1 $ 4.25 4,529,174 $ 5.11 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 201 7 201 6 201 5 Expected term (in years) 5.70 5.25 - 6.25 5.25 - 6.25 Risk-free interest rate 1.82% - 2.09% 1.24% - 1.47% 1.35% - 1.82% Expected volatility 73% 80% 72% Expected dividend rate 0% 0% 0% |
Note 14 - Net Loss Per Share 35
Note 14 - Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Years Ended December 31, 201 7 201 6 201 5 (in thousands, except share and per share amounts) Numerator: Net loss used to compute net loss per share Basic $ (51,508 ) $ (43,157 ) $ (24,399 ) Adjustments for change in fair value of warrant liability — — (2,120 ) Diluted $ (51,508 ) $ (43,157 ) $ (26,519 ) Denominator: Weighted average shares outstanding used to compute net loss per share: Basic 46,883,535 45,313,118 44,300,099 Dilutive effect of warrants — — 168,341 Diluted 46,883,535 45,313,118 44,468,440 Net loss per share —basic $ (1.10 ) $ (0.95 ) $ (0.55 ) Net loss per share —diluted $ (1.10 ) $ (0.95 ) $ (0.60 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 201 7 201 6 201 5 ESPP and stock options to purchase common stock 8,767,783 6,395,879 4,699,121 Convertible debt into common stock — 553,763 553,763 Common stock warrants 176,730 692,611 180,155 |
Note 15 - Accrued Liabilities (
Note 15 - Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 201 7 201 6 Accrued compensation and employee benefits $ 2,190 $ 2,556 Inventory and other contract manufacturing accruals 511 1,218 Other accrued liabilities 842 821 Total accrued liabilities $ 3,543 $ 4,595 |
Note 18 - Income Taxes (Tables)
Note 18 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | December 31, 7 December 31, 6 Current: Federal $ (702 ) $ (39 ) State 1 6 Total Current (701 ) (33 ) Deferred: Federal — (1 ) State — — Total D eferred — (1 ) Provision (benefit) for income taxes $ (701 ) $ (34 ) |
Schedule of Deferred Tax Assets [Table Text Block] | December 31, 7 December 31, 6 Deferred tax assets: Accruals and other $ 2,717 $ 3,746 Research credits 6,530 5,670 Net operating loss carryforward 31,064 36,224 Section 59(e) R&D expenditures 12,156 16,782 Deferred revenue 18,384 24,836 AMT credit — 703 Total deferred tax assets 70,851 87,961 Valuation allowance (70,851 ) (87,961 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, 201 7 2016 2015 Tax at statutory federal rate $ (17,751 ) $ (14,685 ) $ (8,037 ) State tax —net of federal benefit 350 (73 ) 2,853 PIPE Warrant liability (70 ) (260 ) (726 ) General Business credits (316 ) (360 ) (455 ) Stock Options 42 1,115 1,559 Other 51 33 73 Change in valuation allowance (17,110 ) 14,196 5,493 Tax Reform – Tax Rate Change 34,103 — — Provision for income taxes $ (701 ) $ (34 ) $ 760 |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | Year Ended December 31, 2017 2016 2015 Unrecognized benefit —beginning of period $ 2,162 $ 1,939 $ 1,667 Gross decreases —prior period tax positions — — — Gross increases —current period tax positions 203 223 272 Unrecognized benefit —end of period $ 2,365 $ 2,162 $ 1,939 |
Note 19 - Unaudited Quarterly38
Note 19 - Unaudited Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Notes Tables | |
Quarterly Financial Information [Table Text Block] | 201 7 201 6 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Revenues $ 3,109 $ 2,659 $ 1,487 $ 740 $ 3,025 $ 4,531 $ 3,366 $ 6,435 Operating costs and expenses $ 15,182 $ 12,600 $ 10,348 $ 8,547 $ 11,547 $ 12,853 $ 11,341 $ 13,573 Net income / (loss) $ (15,551 ) $ (13,059 ) $ (13,013 ) $ (9,885 ) $ (10,981 ) $ (11,092 ) $ (11,402 ) $ ( 9,682 ) Net income / (loss) per share (basic) $ (0.34 ) $ (0.29 ) $ (0.28 ) $ (0.20 ) $ (0.24 ) $ (0.24 ) $ (0.25 ) $ (0.21 ) Net income / (loss) per share (diluted) $ (0.34 ) $ (0.29 ) $ (0.28 ) $ (0.20 ) $ (0.25 ) $ (0.24 ) $ (0.25 ) $ (0.21 ) |
Note 1 - Organization and Sum39
Note 1 - Organization and Summary of Significant Accounting Policies (Details Textual) $ in Thousands | Sep. 18, 2015USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2017USD ($) |
Inventory Write-down | $ 369 | |||||
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | ||||
Royalty Arrangment Maximum Payments | $ 195,000 | 195,000 | ||||
Net Proceeds from Sale of Future Royalties | $ 61,200 | 61,184 | $ 61,184 | |||
Effective Annual Interest Rate | 14.00% | 14.00% | ||||
Interest Income [Member] | ||||||
Asset Impairment Charges | $ 0 | $ 500 | ||||
Minimum [Member] | ||||||
Property, Plant and Equipment, Useful Life | 3 years | |||||
Maximum [Member] | ||||||
Property, Plant and Equipment, Useful Life | 5 years | |||||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | ||||||
Number of Major Customers | 2 | 2 | 2 | |||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Two Customers [Member] | ||||||
Concentration Risk, Percentage | 100.00% | 100.00% | 100.00% | |||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | One Customer [Member] | ||||||
Concentration Risk, Percentage | 79.00% | 71.00% | 84.00% |
Note 2 - Investments and Fair40
Note 2 - Investments and Fair Value Measurement (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Available-for-sale Securities, Gross, Unrealized Gain (Loss) Accumulated In Investments | $ 0 | $ 0 |
Available-for-sale Securities, Gross Realized Gain (Loss) | 0 | 0 |
Other than Temporary Impairment Losses, Investments, Available-for-sale Securities | 0 | 0 |
Other Comprehensive Income (Loss), Transfers from Held-to-maturity to Available-for-Sale Securities, Net of Tax | $ 0 | $ 0 |
Note 2 - Investments and Fair41
Note 2 - Investments and Fair Value Measurement - Summary of Cash, Cash Equivalents and Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Amortized Cost | $ 60,469 | $ 80,307 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Fair Value | 60,469 | 80,310 |
Cash and cash equivalents: | ||
Amortized Cost | 60,469 | 80,307 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Fair Value | 60,469 | 80,310 |
Cash and Cash Equivalents [Member] | ||
Amortized Cost | 52,902 | 80,307 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Fair Value | 52,902 | 80,310 |
Cash and cash equivalents: | ||
Amortized Cost | 52,902 | 80,307 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Fair Value | 52,902 | 80,310 |
Cash and Cash Equivalents [Member] | Cash [Member] | ||
Amortized Cost | 29,765 | 49,833 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 29,765 | 49,833 |
Cash and cash equivalents: | ||
Amortized Cost | 29,765 | 49,833 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 29,765 | 49,833 |
Cash and Cash Equivalents [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 23,137 | 30,474 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Fair Value | 23,137 | 30,477 |
Cash and cash equivalents: | ||
Amortized Cost | 23,137 | 30,474 |
Gross Unrealized Gains | 3 | |
Gross Unrealized Losses | ||
Fair Value | 23,137 | $ 30,477 |
Marketable Securities [Member] | ||
Amortized Cost | 7,567 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 7,567 | |
Cash and cash equivalents: | ||
Amortized Cost | 7,567 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 7,567 | |
Marketable Securities [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 7,567 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 7,567 | |
Cash and cash equivalents: | ||
Amortized Cost | 7,567 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | $ 7,567 |
Note 2 - Investments and Fair42
Note 2 - Investments and Fair Value Measurement - Fair Value of Financial Assets and Liabilities by Level Within Fair Value Hierarchy (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Assets, fair value | $ 30,704 | $ 30,477 |
Liabilities, fair value | 207 | 412 |
Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 207 | 124 |
PIPE Warrants [Member] | ||
Liabilities, fair value | 288 | |
Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 1 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 1 [Member] | PIPE Warrants [Member] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 30,704 | 30,477 |
Liabilities, fair value | ||
Fair Value, Inputs, Level 2 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 2 [Member] | PIPE Warrants [Member] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | ||
Liabilities, fair value | 207 | 412 |
Fair Value, Inputs, Level 3 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 207 | 124 |
Fair Value, Inputs, Level 3 [Member] | PIPE Warrants [Member] | ||
Liabilities, fair value | 288 | |
U.S. Government Agency Obligations [Member] | ||
Assets, fair value | 30,704 | 30,477 |
U.S. Government Agency Obligations [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | ||
U.S. Government Agency Obligations [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 30,704 | 30,477 |
U.S. Government Agency Obligations [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value |
Note 2 - Investments and Fair43
Note 2 - Investments and Fair Value Measurement - Summary of Changes in Fair Value of Level III Financial Liabilities (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Fair value—beginning of period | $ 412 | $ 1,179 |
Fair value—end of period | 207 | 412 |
PIPE Warrants [Member] | ||
Expiration of fair value of PIPE warrants | (288) | (625) |
Contingent Put Option Liability [Member] | ||
Expiration of fair value of PIPE warrants | $ 83 | $ (142) |
Note 3 - Inventories (Details T
Note 3 - Inventories (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Inventory Write-down | $ 369 | ||
ZALVISO [Member] | |||
Inventory Write-down | $ 400 |
Note 3 - Inventories - Inventor
Note 3 - Inventories - Inventory Components (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Raw materials | $ 702 | $ 1,126 |
Work-in-process | 254 | 296 |
Finished goods | 732 | |
Inventories | $ 956 | $ 2,154 |
Note 4 - Property and Equipme46
Note 4 - Property and Equipment (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Depreciation | $ 1,700 | $ 2,100 | $ 2,000 |
Property, Plant and Equipment, Gross | 19,489 | 17,448 | |
Construction in Progress [Member] | |||
Property, Plant and Equipment, Gross | 9,703 | 7,816 | |
Construction in Progress [Member] | Patheon Cincinnati Facility [Member] | |||
Property, Plant and Equipment, Gross | $ 300 | $ 1,500 |
Note 4 - Property and Equipme47
Note 4 - Property and Equipment - Components of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property and Equipment, Gross | $ 19,489 | $ 17,448 |
Less accumulated depreciation and amortization | (8,438) | (6,736) |
Property and equipment, net | 11,051 | 10,712 |
Laboratory Equipment [Member] | ||
Property and Equipment, Gross | 3,920 | 3,775 |
Leasehold Improvements [Member] | ||
Property and Equipment, Gross | 4,469 | 4,469 |
Computer Equipment and Software [Member] | ||
Property and Equipment, Gross | 241 | 266 |
Construction in Progress [Member] | ||
Property and Equipment, Gross | 9,703 | 7,816 |
Tooling [Member] | ||
Property and Equipment, Gross | 1,109 | 1,074 |
Furniture and Fixtures [Member] | ||
Property and Equipment, Gross | $ 47 | $ 48 |
Note 5 - U.S. Department of D48
Note 5 - U.S. Department of Defense Contract (Details Textual) - USD ($) $ in Thousands | Mar. 09, 2017 | Mar. 02, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Feb. 28, 2018 | May 11, 2015 |
Government Contract Receivable | $ 17,000 | ||||||
Contracts Revenue | $ 852 | $ 10,917 | $ 4,406 | ||||
Subsequent Event [Member] | Amendment to DoD Contract Incorporate Additional Services [Member] | |||||||
Government Contract Receivable | $ 500 | ||||||
Government [Member] | |||||||
Award Contract Renewal Term | 330 days | 120 days | |||||
Government [Member] | Contract and Other Revenue [Member] | |||||||
Contracts Revenue | $ 900 | $ 10,900 | $ 4,400 |
Note 6 - Collaboration Agreem49
Note 6 - Collaboration Agreement (Details Textual) - USD ($) $ in Thousands | Jul. 17, 2015 | Feb. 29, 2016 | Sep. 30, 2015 | Jul. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2017 | Jul. 17, 2015 | Jul. 16, 2015 | Dec. 31, 2017 | Dec. 31, 2016 |
Payments in Exchange for Services Under Collaboration Agreement | $ 700 | ||||||||||
Amount of Binding Product Forecast Revenue | 3,700 | ||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 15,000 | $ 30,000 | $ 5,000 | $ 33,300 | |||||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | $ 194,500 | 194,500 | |||||||||
Manufacturing Agreement, Percentage for Five Years | 100.00% | ||||||||||
Manufacturing Agreement, Percentage, Thereafter | 80.00% | ||||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount | $ 15,000 | ||||||||||
Deferred Revenue | $ 54,400 | 54,400 | $ 1,700 | ||||||||
Collaboration Agreement Consideration, Amount | 35,000 | ||||||||||
Revenue Recognition Milestone Method Agreed, Allocated to Deliverables | 15,000 | ||||||||||
Discount on Manufacturing Services | $ 4,400 | ||||||||||
Committee Participation Sercices Recognized | 200 | ||||||||||
Manufacturing Services Revenues Related to Binding Forecast | 2,300 | ||||||||||
Deferred Revenue, Current | $ 362 | $ 362 | |||||||||
Deferred Revenue, Noncurrent | $ 3,463 | $ 3,824 | |||||||||
AUSTRALIA | |||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | $ 166,000 | ||||||||||
ZALVISO [Member] | |||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | 28,500 | ||||||||||
Milestone Payments Received | $ 5,000 | ||||||||||
ZALVISO [Member] | Europe [Member] | |||||||||||
Revenue Recognition, Milestone Method, Revenue Recognized | 20,000 | ||||||||||
Based upon Net Sales Target Achievements [Member] | |||||||||||
Increase (Decrease) in Milestone Payments Related to Net Sales Target | (5,500) | ||||||||||
Potential Milestone Payments Related to Net Sales Target | 166,000 | $ 171,500 | |||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | 166,000 | 166,000 | |||||||||
Based upon Successful Regulatory and Product Development Efforts [Member] | |||||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | 28,500 | 28,500 | |||||||||
Research and Development and Demonstration Device Systems [Member] | |||||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount | 700 | 700 | |||||||||
Previously Delivered License [Member] | |||||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount | 13,200 | 13,200 | |||||||||
Research and Development and Committee Participation Services [Member] | |||||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount | $ 500 | $ 500 | $ 500 |
Note 6 - Collaboration Agreem50
Note 6 - Collaboration Agreement - Summary of Revenue Recognized Under the Amended Agreements (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Non-cash royalty revenue related to Royalty Monetization (See Note 8) | $ 151 | $ 7 | ||
Royalty revenue | $ 31 | |||
Collaboration agreement | 7,143 | 6,440 | 14,857 | |
Collaborative Arrangement [Member] | ||||
License | 13,167 | |||
Revenue Recognized | 269 | 688 | 1,690 | |
Non-cash royalty revenue related to Royalty Monetization (See Note 8) | 151 | 7 | ||
Royalty revenue | 50 | 3 | ||
Collaboration agreement | 7,143 | 6,440 | 14,857 | |
Collaborative Arrangement [Member] | ZALVISO [Member] | Grunenthal [Member] | ||||
Revenue Recognized | $ 6,673 | $ 5,742 |
Note 7 - Long-term Debt (Detail
Note 7 - Long-term Debt (Details Textual) $ / shares in Units, $ in Thousands | Mar. 02, 2017USD ($) | Sep. 18, 2015$ / sharesshares | Dec. 16, 2013USD ($)$ / sharesshares | Sep. 30, 2016$ / sharesshares | Dec. 31, 2013$ / sharesshares | Jun. 30, 2016$ / shares | Mar. 01, 2020 | Mar. 01, 2019 | Mar. 01, 2018 | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($)shares | Oct. 01, 2017USD ($) | Sep. 17, 2015$ / shares | Dec. 31, 2014USD ($) | Sep. 24, 2014USD ($) | Jun. 16, 2014USD ($) |
Repayments of Long-term Debt | $ 3,514 | $ 4,534 | |||||||||||||||
Common Stock Warrants Exercised | shares | 847,058 | ||||||||||||||||
Fair Value of Contingent Put Option, Liability | 207 | 124 | |||||||||||||||
Interest Expense | 3,316 | $ 2,770 | $ 2,977 | ||||||||||||||
Hercules Warrants [Member] | |||||||||||||||||
Common Stock Warrants Exercised | shares | 176,730 | 176,730 | 176,730 | 176,730 | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.88 | $ 6.79 | $ 3.07 | $ 9.67 | $ 6.79 | ||||||||||||
Investment Warrants, Exercise Price | $ / shares | $ 3.07 | $ 6.79 | $ 3.88 | ||||||||||||||
Amended and Restated Loan and Security Agreement [Member] | |||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 40,000 | ||||||||||||||||
Number of Tranches for Loan and Security Agreement | 3 | ||||||||||||||||
Debt Instrument, Fair Value Disclosure | $ 24,900 | ||||||||||||||||
Long-term Debt Maturities Balloon Payments | $ 1,700 | ||||||||||||||||
Debt Instrument, Variable Rate Threshold | 9.55% | ||||||||||||||||
Debt Instrument, Percentage Used to Calculate Variable Rate | 3.50% | ||||||||||||||||
Debt Instrument, Final Payment, Percentage of Aggregate Principal Amount | 6.50% | ||||||||||||||||
Amended and Restated Loan and Security Agreement [Member] | Prime Rate [Member] | |||||||||||||||||
Debt Instrument, Interest Rate, Effective Percentage | 9.55% | ||||||||||||||||
Amended and Restated Loan and Security Agreement [Member] | First Tranche [Member] | |||||||||||||||||
Debt Instrument, Face Amount | $ 20,500 | $ 15,000 | |||||||||||||||
Repayments of Long-term Debt | 8,600 | ||||||||||||||||
Amended and Restated Loan and Security Agreement [Member] | Second Tranche [Member] | |||||||||||||||||
Debt Instrument, Face Amount | $ 10,000 | ||||||||||||||||
Amended and Restated Loan and Security Agreement [Member] | Third Tranche [Member] | |||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 15,000 | ||||||||||||||||
Hercules Loan and Security Agreement [Member] | |||||||||||||||||
Additional Default Interest Rate | 5.00% | ||||||||||||||||
Fair Value of Contingent Put Option, Liability | $ 32 | 200 | $ 100 | ||||||||||||||
Long-term Line of Credit | 19,100 | 21,500 | |||||||||||||||
Interest Expense | $ 3,300 | $ 2,800 | $ 3,000 | ||||||||||||||
Hercules Loan and Security Agreement [Member] | Scenario, Forecast [Member] | |||||||||||||||||
Prepayment Charge of Term Loan Percentage | 1.00% | 2.00% | 3.00% |
Note 7 - Long-term Debt - Outst
Note 7 - Long-term Debt - Outstanding Future Payments of Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
2,018 | $ 9,350 | |
2,019 | 9,350 | |
2,020 | 3,704 | |
Total payments | 22,404 | |
Less amount representing interest | (2,420) | |
Notes payable, gross | 19,984 | |
Unamortized portion of final payment | (741) | |
Unamortized discount on notes payable | (147) | |
Long-term debt | 19,096 | |
Less current portion of notes payable, including unamortized discount | (7,727) | $ (2,912) |
Long-term debt, current portion | $ 11,369 | $ 18,637 |
Note 8 - Liability Related to53
Note 8 - Liability Related to Sale of Future Royalties (Details Textual) - USD ($) $ in Thousands | Sep. 18, 2015 | Sep. 30, 2015 | Dec. 31, 2017 |
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | |
Royalty Arrangment Maximum Payments | $ 195,000 | 195,000 | |
Revenue Recognition Milestone Method Agreed, Additional Amount | $ 15,000 | ||
Effective Annual Interest Rate | 14.00% | 14.00% | |
Royalty Revenue | $ 31 | ||
First Four Commercial Milestones [Member] | |||
Percentage of Royalties and Rights Under Agreement | 20.00% | ||
Royalties [Member] | |||
Percentage of Royalties and Rights Under Agreement | 25.00% | ||
Remaining Commercial and All Development Milestone[Member] | |||
Percentage of Royalties and Rights Under Agreement | 100.00% | ||
Commercial Milestones Value | $ 43,500 | ||
MAA Aproval [Member] | |||
Revenue Recognition Milestone Method Agreed, Additional Amount | 15,000 | ||
PDL [Member] | |||
Proceeds From Sale of Royalty and Milestone Rights | $ 61,200 | ||
Percentage of Royalties and Rights Under Agreement | 75.00% | ||
PDL [Member] | First Four Commercial Milestones [Member] | |||
Percentage of Royalties and Rights Under Agreement | 80.00% | ||
Commercial Milestones Value Maximum Amount Available | $ 35,600 | ||
AcelRX [Member] | First Four Commercial Milestones [Member] | |||
Commercial Milestones Value Maximum Amount Available | $ 44,500 |
Note 8 - Liability Related to54
Note 8 - Liability Related to Sale of Future Royalties - Activity of Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 27 Months Ended | ||
Sep. 30, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2017 | |
Liability related to sale of future royalties — beginning balance | $ 72,987 | ||||
Proceeds from sale of future royalties | $ 61,200 | $ 61,184 | 61,184 | ||
Non-cash royalty revenue | (120) | (127) | |||
Non-cash interest expense recognized | 10,721 | 9,382 | $ 2,428 | 22,531 | |
Liability related to sale of future royalties as of December 31, 2017 | 83,588 | 72,987 | 83,588 | ||
Less: current portion | (604) | (764) | (604) | ||
Liability related to sale of future royalties — net of current portion | $ 82,984 | $ 72,223 | $ 82,984 |
Note 9 - Warrants (Details Text
Note 9 - Warrants (Details Textual) $ / shares in Units, $ in Thousands | Sep. 18, 2015$ / sharesshares | Dec. 16, 2013$ / sharesshares | Sep. 30, 2016USD ($)$ / sharesshares | Dec. 31, 2013USD ($)$ / shares$ / itemshares | Jun. 30, 2012USD ($)$ / sharesshares | Jun. 30, 2016$ / shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($)shares | Sep. 30, 2015USD ($) | Sep. 17, 2015$ / shares |
Common Stock Warrants Exercised | 847,058 | ||||||||||
Stock Issued During Period, Shares, Common Stock Warrants Exercised | 527,101 | ||||||||||
2012 Private Placement [Member] | |||||||||||
Fair Value of Warrant Upon Execution of Securities Purchase Agreement | $ | $ 5,800 | ||||||||||
Other Expenses | $ | $ 300 | $ 600 | $ 2,100 | ||||||||
Hercules Warrants [Member] | |||||||||||
Common Stock Warrants Exercised | 176,730 | 176,730 | 176,730 | 176,730 | |||||||
Investment Warrants, Exercise Price | $ / shares | $ 3.07 | $ 6.79 | $ 3.88 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.88 | $ 6.79 | $ 3.07 | $ 9.67 | $ 6.79 | ||||||
Warrant Exercisable Term | 5 years | ||||||||||
Fair Value of Warrant On Date Of Issuance | $ | $ 45 | $ 1,100 | $ 100 | ||||||||
Derivative, Price Risk Option Strike Price | $ / item | 6.79 | ||||||||||
Class of Warrant or Right Fair Value Assumption Risk Free Interest Rate | 1.55% | ||||||||||
Class of Warrant or Right Fair Value Assumption Stock Volatility | 71.00% | ||||||||||
Class of Warrant or Right Fair Value Assumption Expected Dividend Yield | 0.00% | ||||||||||
Class of Warrant or Right, Outstanding | 176,730 | ||||||||||
PIPE Warrants [Member] | |||||||||||
Investment Warrants, Exercise Price | $ / shares | $ 3.40 | ||||||||||
Warrant Exercisable Term | 5 years | ||||||||||
Class of Warrant or Right, Outstanding | 2,630,103 | 512,456 | |||||||||
Warrants Vesting Condition Description | 50.00% |
Note 10 - Commitments and Con56
Note 10 - Commitments and Contingencies (Details Textual) $ in Thousands | Jun. 14, 2017USD ($)a | Oct. 02, 2015ft²$ / item | May 31, 2014ft² | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2011ft² |
Rental Rate Per Square Foot | $ / item | 2.05 | ||||||
Future Minimum Sublease Rentals, Sale Leaseback Transactions, Next Twelve Months | $ 300 | ||||||
Future Minimum Sublease Rentals, Sale Leaseback Transactions, within Two Years | 25 | ||||||
Operating Leases, Rent Expense, Net | $ 600 | $ 300 | $ 600 | ||||
Redwood City, California [Member] | |||||||
Area of Operating Lease | ft² | 11,871 | 13,787 | |||||
Lessee, Operating Lease, Term of Contract | 2 years 60 days | ||||||
Lease Extended Term [Member] | |||||||
Area of Operating Lease | ft² | 12,106 | ||||||
Lessee, Operating Lease, Renewal Term | 1 year 261 days | ||||||
Lease Agreement, Term | 3 years 180 days | ||||||
Executive Offices in Redwood City, CA [Member] | Metropolitan Life Insurance Company [Member] | |||||||
Lessee, Operating Lease, Renewal Term | 6 years | ||||||
Area of Real Estate Property | a | 25,893 | ||||||
Operating Lease, Annual Rent | $ 1,200 | ||||||
Lessee, Operating Lease, Term for Annual Rent Increase | 1 year |
Note 10 - Commitments and Con57
Note 10 - Commitments and Contingencies - Future Minimum Payments Under Lease Agreement (Details) $ in Thousands | Dec. 31, 2017USD ($) |
2,018 | $ 959 |
2,019 | 1,231 |
2,020 | 1,268 |
2,021 | 1,305 |
2,022 | 1,345 |
Thereafter | 1,501 |
Total minimum payments | $ 7,609 |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Jun. 21, 2013 | Feb. 10, 2011 | Nov. 30, 2009 | Feb. 29, 2008 | Aug. 31, 2006 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2011 |
Stock Issued During Period, Shares, New Issues | 5,400,000 | ||||||||
Proceeds from Issuance of Common Stock, Net | $ 15.7 | ||||||||
Payments of Stock Issuance Costs | $ 0.5 | ||||||||
Employee Stock Purchase Plan, Shares Issued, Weighted Average Fair Value | $ 2.59 | $ 2.98 | $ 4.48 | ||||||
2006 Equity Incentive Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 342,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,400,000 | 375,000 | |||||||
2006 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||
Common Stock Voting Rights Percentage | 10.00% | ||||||||
Fair Value of Common Stock as Percentage of Option Exercise Price | 110.00% | ||||||||
2011 Equity Incentive Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,800,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other Than Options, Outstanding | 52,000 | 1,900,000 | |||||||
Stock Option Plan Option Reserve Annual Increase as Percentage of Outstanding Shares Allowed | 4.00% | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 2,368,992 | ||||||||
2011 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||||||
Employee Stock Purchase Plan (ESPP) [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 250,000 | ||||||||
Share-based Payment Award, Number of Shares Authorized | 2.00% | ||||||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans | 94,893 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,041,249 | ||||||||
Public Offering [Member] | |||||||||
Proceeds from Issuance Initial Public Offering | $ 40 |
Note 12 - Stock-based Compens59
Note 12 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.91 | $ 2.24 | $ 2.69 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 7,100 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 219 days | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 3,500 | $ 3,900 | $ 5,400 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 40 | $ 0 | $ 1,300 | |
2011 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 2,368,992 | |||
2011 Equity Incentive Plan [Member] | Subsequent Event [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 2,035,966 |
Note 12 - Stock-based Compens60
Note 12 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Stock-based compensation expense | $ 4,294 | $ 4,479 | $ 5,010 |
Cost of Sales [Member] | |||
Stock-based compensation expense | 324 | 302 | 67 |
Research and Development Expense [Member] | |||
Stock-based compensation expense | 1,901 | 2,308 | 2,587 |
General and Administrative Expense [Member] | |||
Stock-based compensation expense | $ 2,069 | $ 1,869 | $ 2,356 |
Note 12 - Stock-based Compens61
Note 12 - Stock-based Compensation - Option Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($)$ / sharesshares | |
Outstanding (in shares) | shares | 6,307,756 |
Outstanding (in dollars per share) | $ / shares | $ 5 |
Granted (in shares) | shares | 3,007,155 |
Granted, weighted-average exercise price (in dollars per share) | $ / shares | $ 2.99 |
Forfeited (in shares) | shares | (438,519) |
Forfeited, weighted-average exercise price (in dollars per share) | $ / shares | $ 4.28 |
Expired (in shares) | shares | (351,922) |
Expired, weighted-average exercise price (in dollars per share) | $ / shares | $ 7.31 |
Exercised (in shares) | shares | (69,372) |
Exercised, weighted-average exercise price (in dollars per share) | $ / shares | $ 1.52 |
Outstanding (in shares) | shares | 8,455,098 |
Outstanding, weighted-average exercise price (in dollars per share) | $ / shares | $ 4.25 |
Outstanding, weighted-average remaining contractual life (Year) | 7 years 36 days |
Outstanding, aggregate intrinsic value | $ | $ 13 |
Vested and exercisable options (in shares) | shares | 4,529,174 |
Vested and exercisable options, weighted-average exercise price (in dollars per share) | $ / shares | $ 5.11 |
Vested and exercisable options, weighted-average remaining contractual life (Year) | 5 years 204 days |
Vested and exercisable options, aggregate intrinsic value | $ | $ 13 |
Vested and expected to vest (in shares) | shares | 8,455,098 |
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ / shares | $ 4.25 |
Vested and expected to vest, weighted-average remaining contractual life (Year) | 7 years 36 days |
Vested and expected to vest, aggregate intrinsic value | $ | $ 13 |
Note 12 - Stock-based Compens62
Note 12 - Stock-based Compensation - Stock Options Outstanding, Vested and Exercisable (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Exercise Price Range, Lower Range Limit (in dollars per share) | ||
Exercise Price Range, Upper Range Limit (in dollars per share) | ||
Number of Stock Options Outstanding (in shares) | 8,455,098 | 6,307,756 |
Weighted-average Remaining Contractual LIfe (Year) | 7 years 36 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 4.25 | $ 5 |
Shares Subject to Stock Options (in shares) | 4,529,174 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 5.11 | |
Exercise Price Range 1 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 1.20 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 2.30 | |
Number of Stock Options Outstanding (in shares) | 105,900 | |
Weighted-average Remaining Contractual LIfe (Year) | 8 years 146 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 2.13 | |
Shares Subject to Stock Options (in shares) | 38,400 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 1.84 | |
Exercise Price Range 2 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 2.40 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 3.77 | |
Number of Stock Options Outstanding (in shares) | 5,592,633 | |
Weighted-average Remaining Contractual LIfe (Year) | 7 years 255 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 3.10 | |
Shares Subject to Stock Options (in shares) | 1,948,300 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 3.17 | |
Exercise Price Range 3 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 3.92 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 6.60 | |
Number of Stock Options Outstanding (in shares) | 2,060,565 | |
Weighted-average Remaining Contractual LIfe (Year) | 5 years 255 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 5.45 | |
Shares Subject to Stock Options (in shares) | 1,880,190 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 5.36 | |
Exercise Price Range 4 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 8.18 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 10.55 | |
Number of Stock Options Outstanding (in shares) | 696,000 | |
Weighted-average Remaining Contractual LIfe (Year) | 6 years 73 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 10.28 | |
Shares Subject to Stock Options (in shares) | 662,284 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 10.28 |
Note 12 - Stock-based Compens63
Note 12 - Stock-based Compensation - Assumptions to Calculate Fair Value of Each Employee Stock Option (Details) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Expected term (in years) (Year) | 5 years 255 days | ||
Expected volatility | 73.00% | 80.00% | 72.00% |
Expected dividend rate | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Expected term (in years) (Year) | 5 years 255 days | 5 years 91 days | 5 years 91 days |
Risk-free interest rate | 1.82% | 1.24% | 1.35% |
Expected volatility | 73.00% | 80.00% | 72.00% |
Expected dividend rate | 0.00% | 0.00% | 0.00% |
Maximum [Member] | |||
Expected term (in years) (Year) | 5 years 255 days | 6 years 91 days | 6 years 91 days |
Risk-free interest rate | 2.09% | 1.47% | 1.82% |
Expected volatility | 73.00% | 80.00% | 72.00% |
Expected dividend rate | 0.00% | 0.00% | 0.00% |
Note 13 - Restructuring Costs (
Note 13 - Restructuring Costs (Details Textual) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2015 | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Restructuring and Related Cost, Number of Positions Eliminated | 19 | |||
Restructuring and Related Cost, Number of Positions Eliminated, Period Percent | 36.00% | |||
Restructuring Charges | $ 756 |
Note 14 - Net Loss Per Share 65
Note 14 - Net Loss Per Share of Common Stock - Computation of Basic and Diluted Net Loss Per Share of Common (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Net loss | $ (9,885) | $ (13,013) | $ (13,059) | $ (15,551) | $ (9,682) | $ (11,402) | $ (11,092) | $ (10,981) | $ (51,508) | $ (43,157) | $ (24,399) |
Adjustments for change in fair value of warrant liability | (2,120) | ||||||||||
Diluted | $ (51,508) | $ (43,157) | $ (26,519) | ||||||||
Shares used in computing net loss per share of common stock, basic (in shares) | 46,883,535 | 45,313,118 | 44,300,099 | ||||||||
Dilutive effect of warrants (in shares) | 168,341 | ||||||||||
Diluted (in shares) | 46,883,535 | 45,313,118 | 44,468,440 | ||||||||
Net loss per share of common stock, basic (in dollars per share) | $ (0.20) | $ (0.28) | $ (0.29) | $ (0.34) | $ (0.21) | $ (0.25) | $ (0.24) | $ (0.24) | $ (1.10) | $ (0.95) | $ (0.55) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.20) | $ (0.28) | $ (0.29) | $ (0.34) | $ (0.21) | $ (0.25) | $ (0.24) | $ (0.25) | $ (1.10) | $ (0.95) | $ (0.60) |
Note 14 - Net Loss Per Share 66
Note 14 - Net Loss Per Share of Common Stock - Common Stock Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employee Stock Option [Member] | |||
Antidilutive securities (in shares) | 8,767,783 | 6,395,879 | 4,699,121 |
Convertible Debt Securities [Member] | |||
Antidilutive securities (in shares) | 553,763 | 553,763 | |
Warrant [Member] | |||
Antidilutive securities (in shares) | 176,730 | 692,611 | 180,155 |
Note 15 - Accrued Liabilities -
Note 15 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued compensation and employee benefits | $ 2,190 | $ 2,556 |
Inventory and other contract manufacturing accruals | 511 | 1,218 |
Other accrued liabilities | 842 | 821 |
Total accrued liabilities | $ 3,543 | $ 4,595 |
Note 16 - 401(k) Plan (Details
Note 16 - 401(k) Plan (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Defined Contribution Plan, Employer Discretionary Contribution Percentage | 4.00% | ||
Contributions by Employer to Postemployment Benefit Obligations | $ 0.3 | $ 0.3 | $ 0.3 |
Note 17 - Related Party Trans69
Note 17 - Related Party Transactions (Details Textual) $ in Millions | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Royalty Monetization [Member] | Dr. Hoffman [Member] | |
Related Party Transaction, Amounts of Transaction | $ 0.3 |
Note 18 - Income Taxes (Details
Note 18 - Income Taxes (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Expense (Benefit) | $ (701,000) | $ (34,000) | $ 760,000 | ||
Valuation Allowances and Reserves, Period Increase (Decrease) | (17,100,000) | 14,200,000 | $ 5,500,000 | ||
Deferred Tax Assets, Tax Credit Carryforwards, Alternative Minimum Tax | $ 703,000 | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 35.00% | ||||
Tax Adjustments, Settlements, and Unusual Provisions | (700,000) | ||||
Income Tax Expense (Benefit), Continuing Operations, Adjustment of Deferred Tax (Asset) Liability | 0 | ||||
Earliest Tax Year [Member] | |||||
Open Tax Year | 2,005 | ||||
Latest Tax Year [Member] | |||||
Open Tax Year | 2,017 | ||||
Subject to Expiration [Member] | |||||
Operating Loss Carryforwards | 1,400,000 | $ 1,400,000 | |||
Scenario, Forecast [Member] | |||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | ||||
Research Tax Credit Carryforward [Member] | Subject to Expiration [Member] | |||||
Tax Credit Carryforward, Amount | 26,000 | 26,000 | |||
Domestic Tax Authority [Member] | |||||
Operating Loss Carryforwards | 115,600,000 | 115,600,000 | |||
Deferred Tax Assets, Tax Credit Carryforwards, Alternative Minimum Tax | 700,000 | 700,000 | |||
Domestic Tax Authority [Member] | Accounting Standards Update 2016-09 [Member] | |||||
Operating Loss Carryforwards | 2,900,000 | 2,900,000 | |||
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | |||||
Tax Credit Carryforward, Amount | 5,900,000 | 5,900,000 | |||
State and Local Jurisdiction [Member] | |||||
Operating Loss Carryforwards | 97,200,000 | 97,200,000 | |||
State and Local Jurisdiction [Member] | Accounting Standards Update 2016-09 [Member] | |||||
Operating Loss Carryforwards | 2,000,000 | 2,000,000 | |||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||||
Tax Credit Carryforward, Amount | $ 3,600,000 | $ 3,600,000 |
Note 18 - Income Taxes - Provis
Note 18 - Income Taxes - Provision (Benefit) for Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Current: | |||
Federal | $ (702,000) | $ (39,000) | |
State | 1,000 | 6,000 | |
Total Current | (701,000) | (33,000) | |
Deferred: | |||
Federal | (1,000) | ||
State | |||
Total Deferred | (1,000) | ||
Provision (benefit) for income taxes | $ (701,000) | $ (34,000) | $ 760,000 |
Note 18 - Income Taxes - Net De
Note 18 - Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accruals and other | $ 2,717 | $ 3,746 |
Research credits | 6,530 | 5,670 |
Net operating loss carryforward | 31,064 | 36,224 |
Section 59(e) R&D expenditures | 12,156 | 16,782 |
Deferred revenue | 18,384 | 24,836 |
AMT credit | 703 | |
Total deferred tax assets | 70,851 | 87,961 |
Valuation allowance | (70,851) | (87,961) |
Net deferred tax assets | $ 0 |
Note 18 - Income Taxes - Reconc
Note 18 - Income Taxes - Reconciliation of Statutory Federal Income Tax (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Tax at statutory federal rate | $ (17,751,000) | $ (14,685,000) | $ (8,037,000) |
State tax—net of federal benefit | 350,000 | (73,000) | 2,853,000 |
PIPE Warrant liability | (70,000) | (260,000) | (726,000) |
General Business credits | (316,000) | (360,000) | (455,000) |
Stock Options | 42,000 | 1,115,000 | 1,559,000 |
Other | 51,000 | 33,000 | 73,000 |
Change in valuation allowance | (17,110,000) | 14,196,000 | 5,493,000 |
Tax Reform – Tax Rate Change | 34,103,000 | ||
Provision (benefit) for income taxes | $ (701,000) | $ (34,000) | $ 760,000 |
Note 18 - Income Taxes - Reco74
Note 18 - Income Taxes - Reconciliation of Beginning and Ending Balance of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Unrecognized benefit—beginning of period | $ 2,162 | $ 1,939 | $ 1,667 |
Gross decreases—prior period tax positions | |||
Gross increases—current period tax positions | 203 | 223 | 272 |
Unrecognized benefit—end of period | $ 2,365 | $ 2,162 | $ 1,939 |
Note 19 - Unaudited Quarterly75
Note 19 - Unaudited Quarterly Financial Data - Quarterly Financial Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Total revenue | $ 740 | $ 1,487 | $ 2,659 | $ 3,109 | $ 6,435 | $ 3,366 | $ 4,531 | $ 3,025 | $ 7,995 | $ 17,357 | $ 19,263 |
Total operating costs and expenses | 8,547 | 10,348 | 12,600 | 15,182 | 13,573 | 11,341 | 12,853 | 11,547 | 46,677 | 49,314 | 39,217 |
Net income / (loss) | $ (9,885) | $ (13,013) | $ (13,059) | $ (15,551) | $ (9,682) | $ (11,402) | $ (11,092) | $ (10,981) | $ (51,508) | $ (43,157) | $ (24,399) |
Net income / (loss) per share (basic) (in dollars per share) | $ (0.20) | $ (0.28) | $ (0.29) | $ (0.34) | $ (0.21) | $ (0.25) | $ (0.24) | $ (0.24) | $ (1.10) | $ (0.95) | $ (0.55) |
Net income / (loss) per share (diluted) (in dollars per share) | $ (0.20) | $ (0.28) | $ (0.29) | $ (0.34) | $ (0.21) | $ (0.25) | $ (0.24) | $ (0.25) | $ (1.10) | $ (0.95) | $ (0.60) |