Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 09, 2021 | Jun. 30, 2020 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0001427925 | ||
Entity Registrant Name | ACELRX PHARMACEUTICALS INC | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2020 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Transition Report | false | ||
Entity File Number | 001-35068 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 41-2193603 | ||
Entity Address, Address Line One | 351 Galveston Drive | ||
Entity Address, City or Town | Redwood City | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94063 | ||
City Area Code | 650 | ||
Local Phone Number | 216-3500 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | ACRX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 95,491,775 | ||
Entity Common Stock, Shares Outstanding | 118,947,830 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current Assets: | ||
Cash and cash equivalents | $ 27,274 | $ 14,684 |
Short-term investments | 15,612 | 51,453 |
Accounts receivable, net | 635 | 432 |
Inventories, net | 1,626 | 3,295 |
Prepaid expenses and other current assets | 1,683 | 1,824 |
Total current assets | 46,830 | 71,688 |
Operating lease right-of-use assets | 3,150 | 3,928 |
Property and equipment, net | 15,659 | 14,552 |
Other assets | 656 | 1,188 |
Total Assets | 66,295 | 91,356 |
Current Liabilities: | ||
Accounts payable | 2,737 | 1,720 |
Accrued liabilities | 4,890 | 5,528 |
Long-term debt, current portion | 8,735 | 4,630 |
Deferred revenue, current portion | 49 | 411 |
Operating lease liabilities, current portion | 1,118 | 970 |
Liability related to the sale of future royalties, current portion | 106 | 352 |
Total current liabilities | 17,635 | 13,611 |
Long-term debt, net of current portion | 13,140 | 20,517 |
Deferred revenue, net of current portion | 0 | 2,833 |
Operating lease liabilities, net of current portion | 2,606 | 3,640 |
Liability related to the sale of future royalties, net of current portion | 88,365 | 91,683 |
Other long-term liabilities | 299 | 490 |
Total liabilities | 122,045 | 132,774 |
Commitments and Contingencies | ||
Stockholders’ Deficit: | ||
Common stock, $0.001 par value—200,000,000 shares authorized as of December 31, 2020 and 2019; 98,812,008 and 79,573,101 shares issued and outstanding as of December 31, 2020 and 2019, respectively | 98 | 79 |
Additional paid-in capital | 382,637 | 356,609 |
Accumulated deficit | (438,485) | (398,106) |
Total stockholders’ deficit | (55,750) | (41,418) |
Total Liabilities and Stockholders’ Deficit | $ 66,295 | $ 91,356 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, issued (in shares) | 98,812,008 | 79,573,101 |
Common stock, outstanding (in shares) | 98,812,008 | 79,573,101 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue: | |||
Revenue | $ 5,416 | $ 2,289 | $ 2,151 |
Operating costs and expenses: | |||
Cost of goods sold | 6,032 | 6,806 | 3,976 |
Research and development | 4,017 | 4,661 | 13,137 |
Selling, general and administrative | 36,330 | 45,027 | 20,765 |
Total operating costs and expenses | 46,379 | 56,494 | 37,878 |
Loss from operations | (40,963) | (54,205) | (35,727) |
Other income (expense): | |||
Interest expense | (3,305) | (2,535) | (2,217) |
Interest income and other income, net | 583 | 2,166 | 1,138 |
Non-cash interest income (expense) on liability related to sale of future royalties | 3,310 | 1,337 | (10,341) |
Total other income (expense) | 588 | 968 | (11,420) |
Net loss before income taxes | (40,375) | (53,237) | (47,147) |
Provision for income taxes | 4 | 3 | 2 |
Net loss | (40,379) | (53,240) | (47,149) |
Comprehensive loss | $ (40,379) | $ (53,240) | $ (47,149) |
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.47) | $ (0.67) | $ (0.81) |
Shares used in computing net loss per share of common stock, basic and diluted –see Note 13 (in shares) | 85,257,008 | 79,184,266 | 58,408,548 |
Product [Member] | |||
Revenue: | |||
Revenue | $ 2,521 | $ 1,830 | $ 825 |
Contract and Other Collaboration [Member] | |||
Revenue: | |||
Revenue | $ 2,895 | $ 459 | $ 1,326 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Cumulative Effect, Period of Adoption, Adjustment [Member]Common Stock [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member]Additional Paid-in Capital [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member]Retained Earnings [Member] | Cumulative Effect, Period of Adoption, Adjustment [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance (in shares) at Dec. 31, 2017 | 50,899,154 | |||||||
Balance at Dec. 31, 2017 | $ 51 | $ 261,310 | $ (297,870) | $ (36,509) | ||||
Stock-based compensation | 5,168 | 5,168 | ||||||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 27,364,301 | |||||||
Net proceeds from issuance of common stock in connection with equity financings | $ 27 | 81,498 | 81,525 | |||||
Issuance of common stock upon exercise of stock options (in shares) | 135,385 | |||||||
Issuance of common stock upon exercise of stock options | $ 0 | 401 | 0 | 401 | ||||
Issuance of common stock upon exercise of warrants (in shares) | 176,730 | |||||||
Issuance of common stock upon exercise of warrants | $ 0 | 542 | 0 | 542 | ||||
Issuance of common stock upon ESPP purchase (in shares) | 182,360 | |||||||
Issuance of common stock upon ESPP purchase | 275 | 275 | ||||||
Net loss | (47,149) | (47,149) | ||||||
Balance (in shares) at Dec. 31, 2018 | 78,757,930 | |||||||
Balance at Dec. 31, 2018 | $ 0 | $ 0 | $ 153 | $ 153 | $ 78 | 349,194 | (345,019) | 4,253 |
Stock-based compensation | 5,057 | 5,057 | ||||||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 500,000 | |||||||
Net proceeds from issuance of common stock in connection with equity financings | 1,233 | 1,233 | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 111,702 | |||||||
Issuance of common stock upon exercise of stock options | $ 0 | 270 | 0 | 270 | ||||
Issuance of common stock upon ESPP purchase (in shares) | 203,469 | |||||||
Issuance of common stock upon ESPP purchase | $ 1 | 472 | 0 | 473 | ||||
Net loss | (53,240) | (53,240) | ||||||
Issuance of warrants related to debt financing | $ 0 | 383 | 0 | 383 | ||||
Balance (in shares) at Dec. 31, 2019 | 79,573,101 | |||||||
Balance at Dec. 31, 2019 | $ 79 | 356,609 | (398,106) | (41,418) | ||||
Stock-based compensation | $ 0 | 4,424 | 0 | 4,424 | ||||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 18,644,095 | |||||||
Net proceeds from issuance of common stock in connection with equity financings | $ 19 | 21,318 | 0 | $ 21,337 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 0 | |||||||
Issuance of common stock upon ESPP purchase (in shares) | 340,128 | |||||||
Issuance of common stock upon ESPP purchase | $ 0 | 372 | 0 | $ 372 | ||||
Net loss | $ 0 | 0 | (40,379) | (40,379) | ||||
Restricted stock units vested (in shares) | 254,684 | |||||||
Tax payments related to shares withheld for restricted stock units vested | (86) | (86) | ||||||
Balance (in shares) at Dec. 31, 2020 | 98,812,008 | |||||||
Balance at Dec. 31, 2020 | $ 98 | $ 382,637 | $ (438,485) | $ (55,750) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | 63 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||
Net loss | $ (40,379,000) | $ (53,240,000) | $ (47,149,000) | |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Non-cash royalty revenue related to royalty monetization | (242,000) | (312,000) | (289,000) | |
Non-cash interest (income) expense on liability related to royalty monetization | (3,310,000) | (1,337,000) | 10,341,000 | $ 28,225,000 |
Depreciation and amortization | 1,853,000 | 1,668,000 | 575,000 | |
Non-cash interest expense related to debt financing | 1,069,000 | 712,000 | 613,000 | |
Stock-based compensation | 4,424,000 | 5,057,000 | 5,168,000 | |
Other | 368,000 | 178,000 | (201,000) | |
Changes in operating assets and liabilities: | ||||
Accounts receivable | (203,000) | (383,000) | 1,484,000 | |
Inventories | 957,000 | (3,392,000) | 102,000 | |
Prepaid expenses and other assets | 661,000 | (333,000) | (850,000) | |
Accounts payable | 1,016,000 | (19,000) | 458,000 | |
Accrued liabilities | (638,000) | 1,141,000 | 922,000 | |
Operating lease liabilities | (886,000) | (701,000) | 0 | |
Deferred revenue | (3,195,000) | (219,000) | (249,000) | |
Net cash used in operating activities | (38,505,000) | (51,180,000) | (29,075,000) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||
Purchase of property and equipment | (1,855,000) | (3,470,000) | (819,000) | |
Purchase of investments | (44,611,000) | (100,068,000) | (30,558,000) | |
Proceeds from maturities of investments | 80,605,000 | 66,975,000 | 20,500,000 | |
Net cash provided by (used in) investing activities | 34,139,000 | (36,563,000) | (10,877,000) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||
Proceeds from issuance of long-term debt | 0 | 25,000,000 | 0 | |
Payment of costs in connection with refinancing of long-term debt | 0 | (190,000) | 0 | |
Payment of long-term debt | (4,667,000) | (3,470,000) | (7,718,000) | |
Extinguishment of debt | 0 | (8,864,000) | 0 | |
Net proceeds from issuance of common stock in connection with equity financings | 21,337,000 | 1,233,000 | 81,525,000 | |
Net proceeds from issuance of common stock through equity plans | 372,000 | 743,000 | 1,218,000 | |
Tax payments related to shares withheld for restricted stock units vested | (86,000) | 0 | 0 | |
Net cash provided by financing activities | 16,956,000 | 14,452,000 | 75,025,000 | |
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS | 12,590,000 | (73,291,000) | 35,073,000 | |
CASH, CASH EQUIVALENTS —Beginning of period | 14,684,000 | 87,975,000 | 52,902,000 | |
CASH, CASH EQUIVALENTS —End of period | 27,274,000 | 14,684,000 | 87,975,000 | $ 27,274,000 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||
Cash paid for interest | 2,269,000 | 1,712,000 | 1,667,000 | |
Income taxes (refunded) paid | (347,000) | (350,000) | 2,000 | |
NONCASH INVESTING AND FINANCING ACTIVITIES: | ||||
Purchases of property and equipment in accounts payable | 0 | 0 | 410,000 | |
Leasehold paid with note payable | 326,000 | 899,000 | 0 | |
Transfer of tenant improvement allowance to sublease | 0 | 242,000 | 0 | |
Establishment of right-of-use asset due to the adoption of ASU 2016-02 | $ 0 | $ 4,730,000 | $ 0 |
Note 1 - Organization and Summa
Note 1 - Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
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, AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA® TM November 2, 2018, first 2019. June 2018, not may one not May 2021 ( Termination of Gr nenthal Amended Agreements The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although Zalviso was approved for sale in Europe on September 18, 2015, third DSUVIA/DZUVEO DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018 June 2018, DSUVIA was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which restricts distribution to certified medically supervised healthcare settings in order to prevent respiratory depression resulting from accidental exposure. DSUVIA is only distributed to facilities certified in the DSUVIA REMS program following attestation by an authorized representative to comply with appropriate dispensing and use restrictions of DSUVIA. To become certified, a healthcare setting is required to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA is not Promotion Agreement On March 15, 2020, May 27, 2020 May 29, 2020, June 4, 2020, July 28, 2020, October 1, 2020, September 30, 2020, Under the terms of this agreement, La Jolla is responsible for maintaining compliance under the agreed marketing and promotion plan and achieving a minimum number of sales calls per calendar quarter. The Company will not The Promotion Agreement has a two may 30 one may 30 may not There were no December 31, 2020. Distribution Agreement On July 17, 2020, ZB Dental’s distribution rights are non-exclusive for crossover ambulatory surgery centers and certain government customers, and do not may not third There were no December 31, 2020. Zalviso Zalviso delivers 15 September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 Termination of Gr nenthal Amended Agreements On December 16, 2013, July 17, 2015 September 20, 2016, 28 September 2015, December 16, 2013, July 22, 2015, July 17, 2015. On May 18, 2020, November 13, 2020. May 2021 May 2021. Except as the context otherwise requires, when we refer to "we," "our," "us," the "Company" or "AcelRx" in this document, we mean AcelRx Pharmaceuticals, Inc., and its consolidated subsidiary. “DZUVEO” is a trademark, and “ACELRX”, “DSUVIA” and “Zalviso” are registered trademarks, all owned by AcelRx Pharmaceuticals, Inc. This report also contains trademarks and trade names that are the property of their respective owners. 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 Balance Sheets as tax receivable and long-term tax receivable have been reclassified to prepaid expenses and other current assets, and other assets, respectively, at December 31, 2019. December 31, 2019 2018, December 31, 2019, December 31, 2018. 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 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 Short-Term Investments 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 commercial paper, U.S. government sponsored enterprise debt securities and corporate 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 and products for the treatment of pain. The Company’s product sales revenue consists of sales of DSUVIA in the United States and Zalviso in Europe. The Company’s contract and collaboration revenue consists of non-cash royalty revenue, royalty revenue, and other revenue under the Grünenthal Agreements. Concentration of Risk The Company invests cash that is currently not The Company relies on a single third third DSUVIA sales are concentrated with the DoD and in a limited number of wholesalers. Zalviso has been sold in Europe by Grünenthal, who terminated the Grünenthal Agreements, effective November 13, 2020. May 2021 Year Ended December 31, Percent of Total Revenue 2020 2019 2018 Grünenthal 74.0 % 83.6 % 61.1 % DoD 16.9 % 0 % 38.9 % Wholesaler A 3.9 % 0 % 0 % Wholesaler B 2.1 % 7.5 % 0 % Wholesaler C 1.2 % 5.7 % 0 % All others 1.9 % 3.2 % 0 % Accounts Receivable, net The need for a bad debt allowance is evaluated each reporting period based on the Company’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in bad debt. The Company has not December 31, 2020 As of December 31, Percent of Accounts Receivable, Net 2020 2019 Customer A 79 % 0 % Customer B 12 % 15 % Customer C 6 % 5 % Customer D 0 % 72 % All Others 3 % 8 % Inventories, net Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first first third November 2018. 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 net realizable value approach as that used to value the inventory. Property and Equipment, net 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 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, if the Company is not may no Contingent put option The contingent put option associated with the Company’s Loan Agreement with Oxford 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 further discussion, see Note 6 Leases In February 2016, No. 2016 02, Leases (Topic 842 January 1, 2019. At the inception of an arrangement, the Company determines whether the arrangement is, or contains, a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not may Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the Consolidated Balance Sheet as operating lease right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, the Company no Revenue from Contracts with Customers The Company follows the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Product sales revenue The Company sells its product primarily through distributors. Revenues from product sales are recognized when distributors obtain control of the Company’s product, which occurs at a point in time, upon delivery to such distributors. These distributors subsequently resell the product to certified medically supervised healthcare settings. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and other certified medically supervised healthcare settings that provide for privately negotiated discounts with respect to the purchase of its products. For revenue recognition under bill-and-hold arrangements, wherein the customer agrees to buy product from the Company but requests delivery at a later date, the Company deems that control passes to the customer when the product is ready for delivery. The Company recognizes revenue under these types of arrangements when a signed agreement is in place, the transaction is billable, the customer has significant risk and rewards for the product and the ability to direct the asset, the product has been set aside specifically for the customer, and the product cannot be redirected to another customer. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, government rebates, returns, distribution fees, GPO fees and product returns. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. The amount of variable consideration that is included in the transaction price may not 606 may Chargebacks not Government Rebates Returns 6 12 may Distribution Fees GPO Fees Trade Discounts and Allowances The Company believes its estimated allowances for chargebacks, government rebates and product returns require a high degree of judgment and are subject to change based on its limited experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distribution fees, GPO fees and trade discounts and allowances do not Contract and other collaboration revenue The Company generates revenue from collaboration agreements. These agreements typically include payments for upfront signing or license fees, cost reimbursements for development and manufacturing services, milestone payments, product sales, and royalties on licensee’s future product sales. Product sales related revenue under these collaboration agreements is classified as product sales revenue, while other revenue generated from collaboration agreements is classified as contract and other collaboration revenue. The Company entered into award contracts with U.S. Department of Defense, or the DoD, to support the development of DSUVIA. These contracts provided for the reimbursement of qualified expenses for research and development activities. Revenue under these arrangements was recognized when the related qualified research expenses were incurred. The Company was entitled to reimbursement of overhead costs associated with the study costs under the DoD arrangements. The Company estimated this overhead rate by utilizing forecasted expenditures. Final reimbursable overhead expenses were dependent on direct labor and direct reimbursable expenses throughout the life of each contract, which increased or decreased based on actual expenses incurred. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price The Company has both fixed and variable consideration. Variable consideration for product revenue is described as Net product sales in the Consolidated Statements of Comprehensive Loss. For collaboration agreements, non-refundable upfront fees and product supply selling prices are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not not not For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights and material rights for discounts on manufacturing services are calculated using an income approach model and can include the following key assumptions: the development timeline, sales forecasts, costs of product sales, commercialization expenses, discount rate, the time which the manufacturing services are expected to be performed, and probabilities of technical and regulatory success. For all other performance obligations, the Company uses a cost- plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under collaboration arrangements and the period over which the Company expects to complete its performance obligations under the arrangement. The Company estimates the performance period or measure of progress at the inception of the arrangement and re-evaluates it each reporting period. This re-evaluation may Cost of Goods Sold Cost of goods sold for product revenue includes third Under the Grünenthal Agreements, the Company sold Zalviso to Grünenthal at predetermined, contractual transfer prices that were less than the direct costs of manufacturing and recognized indirect costs as period costs where they were 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. Advertising Expenses Advertising costs are expensed as incurred. Advertising expenses were $0.5 million, $1.1 million and $0.5 million for the years ended December 31, 2020, 2019 2018, Stock-Based Compensation Compensation expense for all stock-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. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the stock‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical stock price performance over the expected term of the option, which are adjusted as necessary for any other factors which may 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 Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. On March 16, 2020, December 31, 2020, The headcount reduction was completed in the first 2020. No Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties In September 2015, November 13, 2020. May 2021 May 2021. Under the Royalty Monetization, the Company has a continuing obligation to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization is accounted for as a liability that is being amortized using the effective 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 ARPI LLC and payments made to PDL, up to a capped amount of $195.0 million, over the life of the arrangement. The aggregate future estimated royalty and milestone payments (subject to the capped amount), less the $61.2 million of net proceeds the Company received, are amortized as interest expense over the life of the liability. Consequently, the Company imputes interest on the unamortized portion of the liability and records interest expense, or interest income, as these estimates are updated. There are a number of factors that could materially affect the amount and timing of royalty and milestone payments from Zalviso in Europe, most of which are not not may may may The Company records non-cash royalty revenues and non-cash interest income (expense), net, within its Consolidated Statements of Comprehensive Loss over the term of the Royalty Monetization. When the expected payments under the Royalty Monetization are lower than the gross proceeds of $65.0 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, restricted stock units, 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 13 Recently Issued Accounting Pronouncements In June 2016, 2016 13, Financial Instruments Credit Losses: Measurement of Credit Losses on Financial Instruments, 2016 13. 2016 13 2016 13 January 1, 2023, January 1, 2020. May 2019, 2019 05, Financial Instruments Credit Losses, 2019 05, 2016 13. 2016 13 2019 05 not In March 2020, 2020 04, Reference Rate Reform (Topic 848 may December 31, 2022. No. 2021 01, Reference Rate Reform (Topic 848 January 2021. 848 2020 04 2020 04. not |
Note 2 - Investments and Fair V
Note 2 - Investments and Fair Value Measurement | 12 Months Ended |
Dec. 31, 2020 | |
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 The table below summarizes the Company’s cash, cash equivalents and investments (in thousands): As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 5,181 $ — $ — $ 5,181 Money market funds 3,996 — — 3,996 Commercial paper 18,097 — — 18,097 Total cash and cash equivalents 27,274 — — 27,274 Short-term investments: U.S. government agency securities 5,818 — — 5,818 Commercial paper 9,794 — — 9,794 Total short-term investments 15,612 — — 15,612 Total cash, cash equivalents and short-term investments $ 42,886 $ — $ — $ 42,886 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 1,957 $ — $ — $ 1,957 Money market funds 598 — — 598 Commercial paper 12,129 — — 12,129 Total cash and cash equivalents 14,684 — — 14,684 Short-term investments: U.S. government agency securities 14,268 — — 14,268 Commercial paper 27,131 — — 27,131 Corporate debt securities 10,054 — — 10,054 Total short-term investments 51,453 — — 51,453 Total cash, cash equivalents and short-term investments $ 66,137 $ — $ — $ 66,137 None December 31, 2020 2019. December 31, 2020 2019. No December 31, 2020 2019. As of December 31, 2020 2019, one Fair Value Measurement The Company’s financial instruments consist of Level I and II assets and Level III liabilities. Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 third December 31, 2020, December 31, 2019, 6 two 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, 2020 Fair Value Level I Level II Level III Assets Money market funds $ 3,996 $ 3,996 $ — $ — U.S. government agency securities 5,818 — 5,818 — Commercial paper 27,891 — 27,891 — Total assets measured at fair value $ 37,705 $ 3,996 $ 33,709 $ — Liabilities Contingent put option liability $ 246 $ — $ — $ 246 Total liabilities measured at fair value $ 246 $ — $ — $ 246 As of December 31, 2019 Fair Value Level I Level II Level III Assets Money market funds $ 598 $ 598 $ — $ — U.S. government agency securities 14,268 — 14,268 — Commercial paper 39,260 — 39,260 — Corporate debt securities 10,054 — 10,054 — Total assets measured at fair value $ 64,180 $ 598 $ 63,582 $ — Liabilities Contingent put option liability $ 437 $ — $ — $ 437 Total liabilities measured at fair value $ 437 $ — $ — $ 437 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, 2020 2019 Year Ended December 31, 2020 Fair value—beginning of period $ 437 Change in fair value of contingent put option associated with the Loan Agreement (191 ) Fair value—end of period $ 246 Year Ended December 31, 2019 Fair value—beginning of period $ 121 Change in fair value of contingent put option associated with the Loan Agreement 437 Change in fair value of contingent put option associated with the Prior Agreement (121 ) Fair value—end of period $ 437 |
Note 3 - Inventories, Net
Note 3 - Inventories, Net | 12 Months Ended |
Dec. 31, 2020 | |
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 net realizable value and consist of the following (in thousands): As of December 31, 2020 2019 Raw materials $ 257 $ 1,153 Work-in-process 30 593 Finished goods 1,339 1,549 Inventories $ 1,626 $ 3,295 During the year ended December 31, 2020, may December 31, 2019, |
Note 4 - Property and Equipment
Note 4 - Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 4. Property and equipment, net consist of the following (in thousands): As of December 31, 2020 2019 Laboratory equipment $ 4,406 $ 4,389 Leasehold improvements 4,616 4,616 Computer equipment and software 1,724 1,749 Construction in process 14,101 11,949 Tooling 1,109 1,109 Furniture and fixtures 292 292 26,248 24,104 Less accumulated depreciation and amortization (10,589 ) (9,552 ) Property and equipment, net $ 15,659 $ 14,552 Depreciation and amortization expense was $1.1 million, $0.9 million and $0.5 million during the years ended December 31, 2020, 2019 2018, |
Note 5 - Revenue From Contracts
Note 5 - Revenue From Contracts With Customers | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 5 Revenue from Contracts with Customers The following table summarizes revenue from contracts with customers for the years ended December 31, 2020, 2019 2018 December 31, 2020 2019 2018 Product sales: DSUVIA $ 1,409 $ 377 $ — Zalviso 1,112 1,453 825 Total product sales 2,521 1,830 825 Contract and other collaboration: DoD Contract revenue — — 838 Non-cash royalty revenue related to Royalty Monetization (See Note 8) 242 312 289 Royalty revenue 81 104 96 Other revenue 2,572 43 103 Total revenues from contract and other collaboration 2,895 459 1,326 Total revenue $ 5,416 $ 2,289 $ 2,151 For additional detail on the Company’s accounting policy regarding revenue recognition, refer to Note 1 Product Sales The Company’s commercial launch of DSUVIA in the United States occurred in the first 2019. November 13, 2020. May 2021 Contract and Other Collaboration Amended License Agreement Under the Amended License Agreement with Grünenthal, the Company was eligible to receive approximately $194.5 million in additional milestone payments, based upon successful regulatory and product development efforts ($28.5 million) and net sales target achievements ($166.0 million). A portion of the tiered royalty payments earned were paid to PDL in connection with the Royalty Monetization. For additional information on the Royalty Monetization with PDL, see Note 8 August 31, 2020, Amended MSA Under the terms of the Amended MSA with Grünenthal, the Company manufactured and supplied the Product for use in the Field for the Territory exclusively for Grünenthal. The Product was supplied at prices approximating the Company’s manufacturing cost, subject to certain caps, as defined in the MSA Amendment. The Grünenthal Agreements entitled the Company to receive additional payments upon the achievement of certain development milestones which related to post approval product enhancements, expanded market opportunities and manufacturing efficiencies for Zalviso and required future research, development and regulatory activities. These payments were excluded from the transaction price as they were considered payments for optional additional services elected by Grünenthal. The Grünenthal Agreements also included milestone payments related to specified net sales targets, totaling $166.0 606 not In May 2020, DoD Contract On May 11, 2015, February 28, 2019. Contract Liability At December 31, 2020, May 2020, $2.6 no December 31, 2019, The following table presents changes in the Company’s contract liability for the year ended December 31, 2020: Balance at Beginning of the Period Additions Deductions Balance at the end of the Period (in thousands) Contract liability: Deferred revenue – Amended Agreements $ 3,244 $ — $ (3,195 ) $ 49 For the years ended December 31, 2020 2019, Year ended December 31, 2020 Year ended December 31, 2019 Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied $ 623 $ 315 Performance obligations eliminated upon termination 2,572 — New activities in the period from performance obligations satisfied: Performance obligations satisfied 488 1,181 Total revenue from performance obligations satisfied or eliminated $ 3,683 $ 1,496 |
Note 6 - Long-term Debt
Note 6 - Long-term Debt | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | 6. Prior Agreement with Hercules On March 2, 2017, 2014 1 May 30, 2019, Interest expense related to the Prior Agreement was $0.0 million, $0.6 million and $2.2 million for the years ended December 31, 2020, 2019 2018, Loan Agreement with Oxford On May 30, 2019, May 30, 2019. The interest rate is calculated at a rate equal to the sum of (a) the greater of (i) the 30 July 27, 2017, 2021. 2021 not July 1, 2020 June 1, 2023. may July 1, 2021, June 30, 2020, The Company may May 30, 2020, May 30, 2021, May 30, 2021. The Loan Agreement includes customary representations and covenants that, subject to exceptions, will restrict the Company’s ability to do the following things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments; incur additional indebtedness; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not not The Loan Agreement also includes standard events of default, including payment defaults, breaches of covenants following any applicable cure period, a material impairment in the perfection or priority of the Lender’s security interest or in the value of the collateral, a material adverse change in business, operations or the prospect of repayment, events relating to bankruptcy or insolvency. The Loan also contains a cross default provision, under which if a third may may December 31, 2020, 2 In connection with the Loan Agreement, on May 30, 2019, 9 The accrued balance due under the Loan Agreement was $21.0 million and $24.2 million at December 31, 2020 2019, December 31, 2020 2019, Non-Interest Bearing Payments for the Construction of Leasehold Improvements In August 2019, may four July 2022. December 31, 2020, December 31, 2020 The following table summarizes the balance of the future payments at December 31, 2020 ( As of December 31, 2020 Present value of the face amount of $1.0 million $ 865 Less: current portion 402 Long-term debt, net of current portion $ 463 Future Payments on Long-Term Debt The following table summarizes the outstanding future payments associated with the Company’s long-term debt as of December 31, 2020 2021 $ 10,429 2022 9,647 2023 5,530 Total payments 25,606 Less amount representing interest (2,523 ) Notes payable, gross 23,083 Less: Unamortized portion of EOT Fee (524 ) Less: Unamortized discount on notes payable (684 ) Long-term debt 21,875 Less current portion (8,735 ) Long-term debt, net of current portion $ 13,140 |
Note 7 - Leases
Note 7 - Leases | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 7. Office Lease The Company leases office and laboratory space for its corporate headquarters, located at 351 June 2017, February 1, 2018 January 31, 2024 six not February 1 st not On January 2, 2019, February 16, 2019 January 31, 2024, February 1, 2019. January 2, 2019, 45 The transfer of the tenant improvement allowance to the sublessee resulted in a change in cash flows for the New Lease and was accounted for as a modification with changes in lease term and consideration. As a result, the Company remeasured the lease liability with the revised lease payments and recognized approximately $24,000 as a decrease to the lease liability, with a corresponding adjustment to the right-of-use asset. Contract Manufacturing Lease On December 12, 2012, December 31, 2017, two eighteen 2013, June 30, 2022. The components of lease expense are presented in the following table (in thousands): Year ended December 31, 2020 Year ended December 31, 2019 Operating lease costs $ 1,360 $ 1,360 Sublease income (598 ) (596 ) Net lease costs $ 762 $ 764 Other information related to the operating leases is presented in the following table (in thousands): Year ended December 31, 2020 Year ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used for operating leases $ 1,268 $ 1,084 Supplemental non-cash disclosures of lease activities: Transfer of tenant improvement allowance to sublease $ — $ 242 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 4,730 The weighted average remaining lease term and discount rate related to the operating leases are presented in the following table: December 31, December 31, 2020 2019 Weighted-average remaining lease term – operating leases (years) 3.1 4.1 Weighted-average remaining discount rate – operating leases 11.7 % 11.7 % Maturities of lease liabilities as of December 31, 2020 Year: 2021 $ 1,504 2022 1,445 2023 1,386 2024 116 Total future minimum lease payments 4,451 Less imputed interest (727 ) Total $ 3,724 Reported as: Operating lease liabilities $ 1,118 Operating lease liabilities, net of current portion 2,606 Total lease liability $ 3,724 Future minimum sublease payments as of December 31, 2020 Year: 2021 $ 610 2022 629 2023 648 2024 54 Total future minimum sublease payments $ 1,941 The rent receivable balance is reported in the Consolidated Balance Sheets as follows (in thousands): Reported as: Prepaid expenses and other current assets $ 96 Other assets 258 Total rent receivable $ 354 |
Note 8 - Liability Related to S
Note 8 - Liability Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Liability Related To Sale Of Future Royalties Disclosure [Text Block] | 8. On September 18, 2015, first four 80% first four 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 effective 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 ARPI LLC and paid to PDL, up to a capped amount of $195.0 million, over the life of the arrangement. The aggregate future estimated royalty and milestone payments (subject to the capped amount), less the $61.2 million of net proceeds the Company received will be recorded as interest expense over the life of the liability. Consequently, the Company imputes interest on the unamortized portion of the liability and records interest expense relating to the Royalty Monetization accordingly. The Company periodically assesses 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 the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the liability and the effective interest rate. During the three June 30, 2019, $65.0 three June 30, 2020, November 13, 2020. May 2021 May 2021. may The change in estimate reduced the effective interest rate over the life of the liability to 0% by recording interest income over the remaining term of the arrangement as an offset to the interest expense that was recognized in prior periods and resulted in a decrease of $8.1 million to the net loss, or $0.10 per share of common stock, basic and diluted, for the year ended December 31, 2019. December 31, 2020 2019 three December 31, 2018, December 31, 2018 The following table shows the activity within the liability account during the year ended December 31, 2020 ( Year ended December 31, 2020 Period from inception to December 31, 2020 Liability related to sale of future royalties — beginning balance $ 92,035 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (254 ) (938 ) Non-cash interest (income) expense recognized (3,310 ) 28,225 Liability related to sale of future royalties as of December 31, 2020 88,471 88,471 Less: current portion (106 ) (106 ) Liability related to sale of future royalties — net of current portion $ 88,365 $ 88,365 As royalties are remitted to PDL from ARPI LLC, as described in Note 1 August 31, 2020, |
Note 9 - Warrants
Note 9 - Warrants | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Warrants Disclosure [Text Block] | 9. Loan Agreement Warrants In connection with the Loan Agreement, on May 30, 2019, may ten The Company estimated the fair value of these Warrants as of the issuance date to be $0.4 million, which was used in estimating the fair value of the debt instrument and was recorded as equity. The fair value of the Warrants was calculated using the Black-Scholes option-valuation model, and was based on the strike price of $2.83, the stock price at issuance of $2.66, the ten As of December 31, 2020, not May 2029. |
Note 10 - Commitments and Conti
Note 10 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 10. Litigation From time to time the Company may not |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 11. Equity Common Stock 2020 On July 23, 2020, No On December 11, 2020, No ATM Agreement On June 21, 2016, SM may May 9, 2019, may During the year ended December 31, 2020, December 31, 2019, December 31, 2018, As of December 31, 2020, Subsequent to December 31, 2020, January 19, 2021, 17 Stock Plans 2011 In January 2011, 2011 2011 2011 2011 January 1 January 1, 2012 January 1, 2020, December 31 As of June 16, 2020, no may 2011 2011 2011 2011 2020 On June 16, 2020, 2020 2020 2020 The initial aggregate number of shares of the Company’s common stock issuable pursuant to stock awards under the 2020 2011 not 2020 not not Amended and Restated 2011 Additionally, on June 16, 2020, 2011 2011 In the year ended December 31, 2020, 2020, 2019 2018 December 31, 2020, |
Note 12 - Stock-based Compensat
Note 12 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | 12. The Company recorded total stock-based compensation expense for stock options, stock awards and the Amended ESPP as follows (in thousands): December 31, 2020 December 31, 2019 December 31, 2018 Cost of goods sold $ 123 $ 260 $ 358 Research and development 764 920 1,970 Selling, general and administrative 3,537 3,877 2,840 Total $ 4,424 $ 5,057 $ 5,168 The following table summarizes restricted stock unit activity under the Company’s Equity Incentive Plans: Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2019 — $ — Granted 1,029,085 2.53 Vested — — Forfeited (40,440 ) 2.54 Restricted stock units outstanding, December 31, 2019 988,645 $ 2.53 Granted 908,300 1.30 Vested (304,810 ) 2.53 Forfeited (194,152 ) 2.16 Restricted stock units outstanding, December 31, 2020 1,397,983 $ 1.79 The following table summarizes option activity under the Company’s Equity Incentive Plans: Number of Stock Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (in thousands) December 31, 2019 12,648,739 $ 3.47 Granted 1,816,596 1.30 Forfeited (610,518 ) 2.38 Expired (1,041,795 ) 3.68 Exercised — — December 31, 2020 12,813,022 $ 3.20 6.1 $ 298 Vested and exercisable options—December 31, 2020 9,536,806 $ 3.66 5.2 $ — Vested and expected to vest—December 31, 2020 12,813,022 $ 3.20 6.1 $ 298 As of December 31, 2020, 2020 Additional information regarding the Company’s stock options outstanding and vested and exercisable as of December 31, 2020 Options Outstanding Options Vested and Exercisable Exercise Prices Number of Stock Options Outstanding Weighted-Average Remaining Contractual Life (Years) Weighted-Average Exercise Price per Share Shares Subject to Stock Options Weighted-Average Exercise Price per Share $0.84 - $1.31 752,276 9.2 $ 0.84 — $ — $1.43 - $2.15 2,549,458 7.8 $ 1.88 1,148,695 $ 2.00 $2.19 - $3.29 5,216,124 6.7 $ 2.69 4,174,021 $ 2.71 $3.30 - $4.95 2,481,883 4.3 $ 3.51 2,400,809 $ 3.51 $5.31 - $7.97 1,286,781 2.7 $ 5.75 1,286,781 $ 5.75 $8.18 - $12.27 526,500 3.1 $ 10.28 526,500 $ 10.28 12,813,022 6.1 $ 3.20 9,536,806 $ 3.66 The weighted average grant-date fair value of options granted during the years ended December 31, 2020, 2019 2018 December 31, 2020, December 31, 2020, 2019 2018 December 31, 2020, 2019 2018 The Company used the following assumptions to calculate the fair value of each employee stock option: Year Ended December 31, 2020 2019 2018 Expected term (in years) 6.2 6.0 5.9 Risk-free interest rate 0.4% - 1.5% 1.5% - 2.5% 2.5% - 3.1% Expected volatility 83% 85% 83% Expected dividend rate 0% 0% 0% |
Note 13 - Net Loss Per Share of
Note 13 - Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 13. 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, restricted stock units 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 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, 2020 2019 2018 ESPP, RSUs and stock options to purchase common stock 14,541,005 13,798,797 11,797,960 Common stock warrants 176,679 176,679 — |
Note 14 - Accrued Liabilities
Note 14 - Accrued Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 14. Accrued liabilities consist of the following (in thousands): December 31, 2020 2019 Accrued compensation and employee benefits $ 3,293 $ 3,796 Inventory and other contract manufacturing accruals 137 752 Other accrued liabilities 1,460 980 Total accrued liabilities $ 4,890 $ 5,528 |
Note 15 - 401(k) Plan
Note 15 - 401(k) Plan | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Retirement Benefits [Text Block] | 15. 401 The Company sponsors a 401 401 401 December 31, 2020, 2019 2018, |
Note 16 - Income Taxes
Note 16 - Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 16. The Company recorded a provision for income taxes of $4.0 thousand, $3.0 thousand and $2.0 thousand during the years ended December 31, 2020, 2019 2018, Net deferred tax assets as of December 31, 2020 2019 December 31, 2020 December 31, 2019 Deferred tax assets: Accruals and other $ 4,136 $ 3,672 Research credits 7,275 7,275 Net operating loss carryforward 65,274 52,361 Section 59(e) R&D expenditures 7,473 8,933 Deferred revenue 20,848 21,324 Total deferred tax assets 105,006 93,565 Valuation allowance (105,006 ) (93,565 ) Net deferred tax assets $ — $ — Reconciliations of the statutory federal income tax to the Company’s effective tax during the years ended December 31, 2020, 2019 2018 Year Ended December 31, 2020 2019 2018 Tax at statutory federal rate $ (8,486 ) $ (11,180 ) $ (9,901 ) State tax—net of federal benefit (3,587 ) (2,538 ) (792 ) General business credits — — (500 ) Stock options 636 800 1,048 Other — 7 295 Change in valuation allowance 11,441 12,914 9,852 Provision for income taxes $ 4 $ 3 $ 2 ASC 740 not.” December 31, 2020, 2019 2018, As of December 31, 2020, January 1, 2018 2029. 2018 2020 80% December 31, 2020, 2028. As of December 31, 2020, 2026. December 31, 2020, Under Section 382 1986, 50% three may December 31, 2013, two first 2006 second July 2013 not Uncertain Tax Positions A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2020, 2019 2018 Year Ended December 31, 2020 2019 2018 Unrecognized benefit—beginning of period $ 2,635 $ 2,635 $ 2,365 Gross increases—prior period tax positions — — 57 Gross increases—current period tax positions — — 213 Unrecognized benefit—end of period $ 2,635 $ 2,635 $ 2,635 The entire amount of the unrecognized tax benefits would not There were no accrued interest or penalties related to unrecognized tax benefits in the years ended December 31, 2020, 2019 2018. 2005 2014, 2016 2020, not not 12 |
Note 17 - Subsequent Event
Note 17 - Subsequent Event | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 17. On January 22, 2021, January 27, 2021, 3 No. 333 239156 June 12, 2020 July 8, 2020. Subsequent to December 31, 2020, March 4, 2021, may |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2020 | |
Notes to Financial Statements | |
SEC Schedule, 12-09, Schedule of Valuation and Qualifying Accounts Disclosure [Text Block] | SCHEDULE II: VALUATION AND QUALIFYING ACCOUNTS (in thousands) Additions Balance at Charged as a Balance at Beginning of Reduction to End of Description Period Revenue Deductions* Period Sales & return allowances, discounts, chargebacks and rebates: Year ended December 31, 2020 $ 161 $ 645 $ (138 ) $ 668 Year ended December 31, 2019 $ — $ 201 $ (40 ) $ 161 Year ended December 31, 2018 $ — $ — $ — $ — * Deductions to sales discounts and allowances relate to discounts or allowances actually taken or paid. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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, AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA® TM November 2, 2018, first 2019. June 2018, not may one not May 2021 ( Termination of Gr nenthal Amended Agreements The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although Zalviso was approved for sale in Europe on September 18, 2015, third DSUVIA/DZUVEO DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018 June 2018, DSUVIA was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which restricts distribution to certified medically supervised healthcare settings in order to prevent respiratory depression resulting from accidental exposure. DSUVIA is only distributed to facilities certified in the DSUVIA REMS program following attestation by an authorized representative to comply with appropriate dispensing and use restrictions of DSUVIA. To become certified, a healthcare setting is required to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA is not Promotion Agreement On March 15, 2020, May 27, 2020 May 29, 2020, June 4, 2020, July 28, 2020, October 1, 2020, September 30, 2020, Under the terms of this agreement, La Jolla is responsible for maintaining compliance under the agreed marketing and promotion plan and achieving a minimum number of sales calls per calendar quarter. The Company will not The Promotion Agreement has a two may 30 one may 30 may not There were no December 31, 2020. Distribution Agreement On July 17, 2020, ZB Dental’s distribution rights are non-exclusive for crossover ambulatory surgery centers and certain government customers, and do not may not third There were no December 31, 2020. Zalviso Zalviso delivers 15 September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 Termination of Gr nenthal Amended Agreements On December 16, 2013, July 17, 2015 September 20, 2016, 28 September 2015, December 16, 2013, July 22, 2015, July 17, 2015. On May 18, 2020, November 13, 2020. May 2021 May 2021. Except as the context otherwise requires, when we refer to "we," "our," "us," the "Company" or "AcelRx" in this document, we mean AcelRx Pharmaceuticals, Inc., and its consolidated subsidiary. “DZUVEO” is a trademark, and “ACELRX”, “DSUVIA” and “Zalviso” are registered trademarks, all owned by AcelRx Pharmaceuticals, Inc. This report also contains trademarks and trade names that are the property of their respective owners. |
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, Comparability Adjustment [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 Balance Sheets as tax receivable and long-term tax receivable have been reclassified to prepaid expenses and other current assets, and other assets, respectively, at December 31, 2019. December 31, 2019 2018, December 31, 2019, December 31, 2018. |
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 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 Short-Term Investments 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 commercial paper, U.S. government sponsored enterprise debt securities and corporate 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 and products for the treatment of pain. The Company’s product sales revenue consists of sales of DSUVIA in the United States and Zalviso in Europe. The Company’s contract and collaboration revenue consists of non-cash royalty revenue, royalty revenue, and other revenue under the Grünenthal Agreements. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Risk The Company invests cash that is currently not The Company relies on a single third third DSUVIA sales are concentrated with the DoD and in a limited number of wholesalers. Zalviso has been sold in Europe by Grünenthal, who terminated the Grünenthal Agreements, effective November 13, 2020. May 2021 Year Ended December 31, Percent of Total Revenue 2020 2019 2018 Grünenthal 74.0 % 83.6 % 61.1 % DoD 16.9 % 0 % 38.9 % Wholesaler A 3.9 % 0 % 0 % Wholesaler B 2.1 % 7.5 % 0 % Wholesaler C 1.2 % 5.7 % 0 % All others 1.9 % 3.2 % 0 % |
Receivable [Policy Text Block] | Accounts Receivable, net The need for a bad debt allowance is evaluated each reporting period based on the Company’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in bad debt. The Company has not December 31, 2020 As of December 31, Percent of Accounts Receivable, Net 2020 2019 Customer A 79 % 0 % Customer B 12 % 15 % Customer C 6 % 5 % Customer D 0 % 72 % All Others 3 % 8 % |
Inventory, Policy [Policy Text Block] | Inventories, net Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first first third November 2018. 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 net realizable value approach as that used to value the inventory. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment, net 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 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, if the Company is not may no |
Contingent Put Option, Policy [Policy Text Block] | Contingent put option The contingent put option associated with the Company’s Loan Agreement with Oxford 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 further discussion, see Note 6 |
Lessee, Leases [Policy Text Block] | Leases In February 2016, No. 2016 02, Leases (Topic 842 January 1, 2019. At the inception of an arrangement, the Company determines whether the arrangement is, or contains, a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not may Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the Consolidated Balance Sheet as operating lease right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, the Company no |
Revenue [Policy Text Block] | Revenue from Contracts with Customers The Company follows the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Product sales revenue The Company sells its product primarily through distributors. Revenues from product sales are recognized when distributors obtain control of the Company’s product, which occurs at a point in time, upon delivery to such distributors. These distributors subsequently resell the product to certified medically supervised healthcare settings. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and other certified medically supervised healthcare settings that provide for privately negotiated discounts with respect to the purchase of its products. For revenue recognition under bill-and-hold arrangements, wherein the customer agrees to buy product from the Company but requests delivery at a later date, the Company deems that control passes to the customer when the product is ready for delivery. The Company recognizes revenue under these types of arrangements when a signed agreement is in place, the transaction is billable, the customer has significant risk and rewards for the product and the ability to direct the asset, the product has been set aside specifically for the customer, and the product cannot be redirected to another customer. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, government rebates, returns, distribution fees, GPO fees and product returns. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. The amount of variable consideration that is included in the transaction price may not 606 may Chargebacks not Government Rebates Returns 6 12 may Distribution Fees GPO Fees Trade Discounts and Allowances The Company believes its estimated allowances for chargebacks, government rebates and product returns require a high degree of judgment and are subject to change based on its limited experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distribution fees, GPO fees and trade discounts and allowances do not Contract and other collaboration revenue The Company generates revenue from collaboration agreements. These agreements typically include payments for upfront signing or license fees, cost reimbursements for development and manufacturing services, milestone payments, product sales, and royalties on licensee’s future product sales. Product sales related revenue under these collaboration agreements is classified as product sales revenue, while other revenue generated from collaboration agreements is classified as contract and other collaboration revenue. The Company entered into award contracts with U.S. Department of Defense, or the DoD, to support the development of DSUVIA. These contracts provided for the reimbursement of qualified expenses for research and development activities. Revenue under these arrangements was recognized when the related qualified research expenses were incurred. The Company was entitled to reimbursement of overhead costs associated with the study costs under the DoD arrangements. The Company estimated this overhead rate by utilizing forecasted expenditures. Final reimbursable overhead expenses were dependent on direct labor and direct reimbursable expenses throughout the life of each contract, which increased or decreased based on actual expenses incurred. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price The Company has both fixed and variable consideration. Variable consideration for product revenue is described as Net product sales in the Consolidated Statements of Comprehensive Loss. For collaboration agreements, non-refundable upfront fees and product supply selling prices are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not not not For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights and material rights for discounts on manufacturing services are calculated using an income approach model and can include the following key assumptions: the development timeline, sales forecasts, costs of product sales, commercialization expenses, discount rate, the time which the manufacturing services are expected to be performed, and probabilities of technical and regulatory success. For all other performance obligations, the Company uses a cost- plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under collaboration arrangements and the period over which the Company expects to complete its performance obligations under the arrangement. The Company estimates the performance period or measure of progress at the inception of the arrangement and re-evaluates it each reporting period. This re-evaluation may |
Cost of Goods and Service [Policy Text Block] | Cost of Goods Sold Cost of goods sold for product revenue includes third Under the Grünenthal Agreements, the Company sold Zalviso to Grünenthal at predetermined, contractual transfer prices that were less than the direct costs of manufacturing and recognized indirect costs as period costs where they were 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. |
Advertising Cost [Policy Text Block] | Advertising Expenses Advertising costs are expensed as incurred. Advertising expenses were $0.5 million, $1.1 million and $0.5 million for the years ended December 31, 2020, 2019 2018, |
Share-based Payment Arrangement [Policy Text Block] | Stock-Based Compensation Compensation expense for all stock-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. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the stock‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical stock price performance over the expected term of the option, which are adjusted as necessary for any other factors which may 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 Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. On March 16, 2020, December 31, 2020, The headcount reduction was completed in the first 2020. No |
Interest Expense, Policy [Policy Text Block] | Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties In September 2015, November 13, 2020. May 2021 May 2021. Under the Royalty Monetization, the Company has a continuing obligation to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization is accounted for as a liability that is being amortized using the effective 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 ARPI LLC and payments made to PDL, up to a capped amount of $195.0 million, over the life of the arrangement. The aggregate future estimated royalty and milestone payments (subject to the capped amount), less the $61.2 million of net proceeds the Company received, are amortized as interest expense over the life of the liability. Consequently, the Company imputes interest on the unamortized portion of the liability and records interest expense, or interest income, as these estimates are updated. There are a number of factors that could materially affect the amount and timing of royalty and milestone payments from Zalviso in Europe, most of which are not not may may may The Company records non-cash royalty revenues and non-cash interest income (expense), net, within its Consolidated Statements of Comprehensive Loss over the term of the Royalty Monetization. When the expected payments under the Royalty Monetization are lower than the gross proceeds of $65.0 |
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, restricted stock units, 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 13 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued Accounting Pronouncements In June 2016, 2016 13, Financial Instruments Credit Losses: Measurement of Credit Losses on Financial Instruments, 2016 13. 2016 13 2016 13 January 1, 2023, January 1, 2020. May 2019, 2019 05, Financial Instruments Credit Losses, 2019 05, 2016 13. 2016 13 2019 05 not In March 2020, 2020 04, Reference Rate Reform (Topic 848 may December 31, 2022. No. 2021 01, Reference Rate Reform (Topic 848 January 2021. 848 2020 04 2020 04. not |
Note 1 - Organization and Sum_2
Note 1 - Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Year Ended December 31, Percent of Total Revenue 2020 2019 2018 Grünenthal 74.0 % 83.6 % 61.1 % DoD 16.9 % 0 % 38.9 % Wholesaler A 3.9 % 0 % 0 % Wholesaler B 2.1 % 7.5 % 0 % Wholesaler C 1.2 % 5.7 % 0 % All others 1.9 % 3.2 % 0 % As of December 31, Percent of Accounts Receivable, Net 2020 2019 Customer A 79 % 0 % Customer B 12 % 15 % Customer C 6 % 5 % Customer D 0 % 72 % All Others 3 % 8 % |
Note 2 - Investments and Fair_2
Note 2 - Investments and Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Cash, Cash Equivalents and Investments [Table Text Block] | As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 5,181 $ — $ — $ 5,181 Money market funds 3,996 — — 3,996 Commercial paper 18,097 — — 18,097 Total cash and cash equivalents 27,274 — — 27,274 Short-term investments: U.S. government agency securities 5,818 — — 5,818 Commercial paper 9,794 — — 9,794 Total short-term investments 15,612 — — 15,612 Total cash, cash equivalents and short-term investments $ 42,886 $ — $ — $ 42,886 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 1,957 $ — $ — $ 1,957 Money market funds 598 — — 598 Commercial paper 12,129 — — 12,129 Total cash and cash equivalents 14,684 — — 14,684 Short-term investments: U.S. government agency securities 14,268 — — 14,268 Commercial paper 27,131 — — 27,131 Corporate debt securities 10,054 — — 10,054 Total short-term investments 51,453 — — 51,453 Total cash, cash equivalents and short-term investments $ 66,137 $ — $ — $ 66,137 |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | As of December 31, 2020 Fair Value Level I Level II Level III Assets Money market funds $ 3,996 $ 3,996 $ — $ — U.S. government agency securities 5,818 — 5,818 — Commercial paper 27,891 — 27,891 — Total assets measured at fair value $ 37,705 $ 3,996 $ 33,709 $ — Liabilities Contingent put option liability $ 246 $ — $ — $ 246 Total liabilities measured at fair value $ 246 $ — $ — $ 246 As of December 31, 2019 Fair Value Level I Level II Level III Assets Money market funds $ 598 $ 598 $ — $ — U.S. government agency securities 14,268 — 14,268 — Commercial paper 39,260 — 39,260 — Corporate debt securities 10,054 — 10,054 — Total assets measured at fair value $ 64,180 $ 598 $ 63,582 $ — Liabilities Contingent put option liability $ 437 $ — $ — $ 437 Total liabilities measured at fair value $ 437 $ — $ — $ 437 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Year Ended December 31, 2020 Fair value—beginning of period $ 437 Change in fair value of contingent put option associated with the Loan Agreement (191 ) Fair value—end of period $ 246 Year Ended December 31, 2019 Fair value—beginning of period $ 121 Change in fair value of contingent put option associated with the Loan Agreement 437 Change in fair value of contingent put option associated with the Prior Agreement (121 ) Fair value—end of period $ 437 |
Note 3 - Inventories, Net (Tabl
Note 3 - Inventories, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | As of December 31, 2020 2019 Raw materials $ 257 $ 1,153 Work-in-process 30 593 Finished goods 1,339 1,549 Inventories $ 1,626 $ 3,295 |
Note 4 - Property and Equipme_2
Note 4 - Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | As of December 31, 2020 2019 Laboratory equipment $ 4,406 $ 4,389 Leasehold improvements 4,616 4,616 Computer equipment and software 1,724 1,749 Construction in process 14,101 11,949 Tooling 1,109 1,109 Furniture and fixtures 292 292 26,248 24,104 Less accumulated depreciation and amortization (10,589 ) (9,552 ) Property and equipment, net $ 15,659 $ 14,552 |
Note 5 - Revenue From Contrac_2
Note 5 - Revenue From Contracts With Customers (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | December 31, 2020 2019 2018 Product sales: DSUVIA $ 1,409 $ 377 $ — Zalviso 1,112 1,453 825 Total product sales 2,521 1,830 825 Contract and other collaboration: DoD Contract revenue — — 838 Non-cash royalty revenue related to Royalty Monetization (See Note 8) 242 312 289 Royalty revenue 81 104 96 Other revenue 2,572 43 103 Total revenues from contract and other collaboration 2,895 459 1,326 Total revenue $ 5,416 $ 2,289 $ 2,151 |
Contract with Customer, Contract Asset, Contract Liability, and Receivable [Table Text Block] | Balance at Beginning of the Period Additions Deductions Balance at the end of the Period (in thousands) Contract liability: Deferred revenue – Amended Agreements $ 3,244 $ — $ (3,195 ) $ 49 Year ended December 31, 2020 Year ended December 31, 2019 Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied $ 623 $ 315 Performance obligations eliminated upon termination 2,572 — New activities in the period from performance obligations satisfied: Performance obligations satisfied 488 1,181 Total revenue from performance obligations satisfied or eliminated $ 3,683 $ 1,496 |
Note 6 - Long-term Debt (Tables
Note 6 - Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Long-term Debt Instruments [Table Text Block] | As of December 31, 2020 Present value of the face amount of $1.0 million $ 865 Less: current portion 402 Long-term debt, net of current portion $ 463 |
Schedule of Maturities of Long-term Debt [Table Text Block] | 2021 $ 10,429 2022 9,647 2023 5,530 Total payments 25,606 Less amount representing interest (2,523 ) Notes payable, gross 23,083 Less: Unamortized portion of EOT Fee (524 ) Less: Unamortized discount on notes payable (684 ) Long-term debt 21,875 Less current portion (8,735 ) Long-term debt, net of current portion $ 13,140 |
Note 7 - Leases (Tables)
Note 7 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Year ended December 31, 2020 Year ended December 31, 2019 Operating lease costs $ 1,360 $ 1,360 Sublease income (598 ) (596 ) Net lease costs $ 762 $ 764 Year ended December 31, 2020 Year ended December 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows used for operating leases $ 1,268 $ 1,084 Supplemental non-cash disclosures of lease activities: Transfer of tenant improvement allowance to sublease $ — $ 242 Right-of-use assets obtained in exchange for new operating lease liabilities $ — $ 4,730 December 31, December 31, 2020 2019 Weighted-average remaining lease term – operating leases (years) 3.1 4.1 Weighted-average remaining discount rate – operating leases 11.7 % 11.7 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Year: 2021 $ 1,504 2022 1,445 2023 1,386 2024 116 Total future minimum lease payments 4,451 Less imputed interest (727 ) Total $ 3,724 Reported as: Operating lease liabilities $ 1,118 Operating lease liabilities, net of current portion 2,606 Total lease liability $ 3,724 |
Lessee, Operating Sublease, to Be Received, Maturity [Table Text Block] | Year: 2021 $ 610 2022 629 2023 648 2024 54 Total future minimum sublease payments $ 1,941 Reported as: Prepaid expenses and other current assets $ 96 Other assets 258 Total rent receivable $ 354 |
Note 8 - Liability Related to_2
Note 8 - Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Other Liabilities [Table Text Block] | Year ended December 31, 2020 Period from inception to December 31, 2020 Liability related to sale of future royalties — beginning balance $ 92,035 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (254 ) (938 ) Non-cash interest (income) expense recognized (3,310 ) 28,225 Liability related to sale of future royalties as of December 31, 2020 88,471 88,471 Less: current portion (106 ) (106 ) Liability related to sale of future royalties — net of current portion $ 88,365 $ 88,365 |
Note 12 - Stock-based Compens_2
Note 12 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | December 31, 2020 December 31, 2019 December 31, 2018 Cost of goods sold $ 123 $ 260 $ 358 Research and development 764 920 1,970 Selling, general and administrative 3,537 3,877 2,840 Total $ 4,424 $ 5,057 $ 5,168 |
Share-based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity [Table Text Block] | Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2019 — $ — Granted 1,029,085 2.53 Vested — — Forfeited (40,440 ) 2.54 Restricted stock units outstanding, December 31, 2019 988,645 $ 2.53 Granted 908,300 1.30 Vested (304,810 ) 2.53 Forfeited (194,152 ) 2.16 Restricted stock units outstanding, December 31, 2020 1,397,983 $ 1.79 |
Share-based Payment Arrangement, Option, Activity [Table Text Block] | Number of Stock Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (in thousands) December 31, 2019 12,648,739 $ 3.47 Granted 1,816,596 1.30 Forfeited (610,518 ) 2.38 Expired (1,041,795 ) 3.68 Exercised — — December 31, 2020 12,813,022 $ 3.20 6.1 $ 298 Vested and exercisable options—December 31, 2020 9,536,806 $ 3.66 5.2 $ — Vested and expected to vest—December 31, 2020 12,813,022 $ 3.20 6.1 $ 298 |
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 Outstanding Weighted-Average Remaining Contractual Life (Years) Weighted-Average Exercise Price per Share Shares Subject to Stock Options Weighted-Average Exercise Price per Share $0.84 - $1.31 752,276 9.2 $ 0.84 — $ — $1.43 - $2.15 2,549,458 7.8 $ 1.88 1,148,695 $ 2.00 $2.19 - $3.29 5,216,124 6.7 $ 2.69 4,174,021 $ 2.71 $3.30 - $4.95 2,481,883 4.3 $ 3.51 2,400,809 $ 3.51 $5.31 - $7.97 1,286,781 2.7 $ 5.75 1,286,781 $ 5.75 $8.18 - $12.27 526,500 3.1 $ 10.28 526,500 $ 10.28 12,813,022 6.1 $ 3.20 9,536,806 $ 3.66 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2020 2019 2018 Expected term (in years) 6.2 6.0 5.9 Risk-free interest rate 0.4% - 1.5% 1.5% - 2.5% 2.5% - 3.1% Expected volatility 83% 85% 83% Expected dividend rate 0% 0% 0% |
Note 13 - Net Loss Per Share _2
Note 13 - Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 2020 2019 2018 ESPP, RSUs and stock options to purchase common stock 14,541,005 13,798,797 11,797,960 Common stock warrants 176,679 176,679 — |
Note 14 - Accrued Liabilities (
Note 14 - Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2020 2019 Accrued compensation and employee benefits $ 3,293 $ 3,796 Inventory and other contract manufacturing accruals 137 752 Other accrued liabilities 1,460 980 Total accrued liabilities $ 4,890 $ 5,528 |
Note 16 - Income Taxes (Tables)
Note 16 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Schedule of Deferred Tax Assets [Table Text Block] | December 31, 2020 December 31, 2019 Deferred tax assets: Accruals and other $ 4,136 $ 3,672 Research credits 7,275 7,275 Net operating loss carryforward 65,274 52,361 Section 59(e) R&D expenditures 7,473 8,933 Deferred revenue 20,848 21,324 Total deferred tax assets 105,006 93,565 Valuation allowance (105,006 ) (93,565 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, 2020 2019 2018 Tax at statutory federal rate $ (8,486 ) $ (11,180 ) $ (9,901 ) State tax—net of federal benefit (3,587 ) (2,538 ) (792 ) General business credits — — (500 ) Stock options 636 800 1,048 Other — 7 295 Change in valuation allowance 11,441 12,914 9,852 Provision for income taxes $ 4 $ 3 $ 2 |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | Year Ended December 31, 2020 2019 2018 Unrecognized benefit—beginning of period $ 2,635 $ 2,635 $ 2,365 Gross increases—prior period tax positions — — 57 Gross increases—current period tax positions — — 213 Unrecognized benefit—end of period $ 2,635 $ 2,635 $ 2,635 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Notes Tables | |
Valuation Allowances and Reserves [Table Text Block] | Additions Balance at Charged as a Balance at Beginning of Reduction to End of Description Period Revenue Deductions* Period Sales & return allowances, discounts, chargebacks and rebates: Year ended December 31, 2020 $ 161 $ 645 $ (138 ) $ 668 Year ended December 31, 2019 $ — $ 201 $ (40 ) $ 161 Year ended December 31, 2018 $ — $ — $ — $ — |
Note 1 - Organization and Sum_3
Note 1 - Organization and Summary of Significant Accounting Policies (Details Textual) $ in Thousands | Jun. 04, 2020USD ($) | Mar. 16, 2020 | Sep. 18, 2015USD ($) | Sep. 30, 2015USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2020USD ($) |
Advertising Expense | $ 500 | $ 1,100 | $ 500 | |||||
Restructuring and Related Cost, Number of Positions Eliminated | 30 | |||||||
Restructuring Charges, Total | 500 | |||||||
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 | $ 0 | $ 61,184 | |||||
Minimum [Member] | ||||||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |||||||
Maximum [Member] | ||||||||
Property, Plant and Equipment, Useful Life (Year) | 5 years | |||||||
Tetraphase [Member] | ||||||||
Merger Agreement, Charges, Net of Termination Fee | $ 1,100 |
Note 1 - Organization and Sum_4
Note 1 - Organization and Summary of Significant Accounting Policies - Concentration of Revenue and Accounts Receivable (Details) - Customer Concentration Risk [Member] | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue Benchmark [Member] | Grunenthal [Member] | |||
Concentration risk | 74.00% | 83.60% | 61.10% |
Revenue Benchmark [Member] | DoD [Member] | |||
Concentration risk | 16.90% | 0.00% | 38.90% |
Revenue Benchmark [Member] | Wholesaler A [Member] | |||
Concentration risk | 3.90% | 0.00% | 0.00% |
Revenue Benchmark [Member] | Wholesaler B [Member] | |||
Concentration risk | 2.10% | 7.50% | 0.00% |
Revenue Benchmark [Member] | Wholesaler C [Member] | |||
Concentration risk | 1.20% | 5.70% | 0.00% |
Revenue Benchmark [Member] | All Others [Member] | |||
Concentration risk | 1.90% | 3.20% | 0.00% |
Accounts Receivable [Member] | Customer A [Member] | |||
Concentration risk | 79.00% | 0.00% | |
Accounts Receivable [Member] | Customer B [Member] | |||
Concentration risk | 12.00% | 15.00% | |
Accounts Receivable [Member] | Customer C [Member] | |||
Concentration risk | 6.00% | 5.00% | |
Accounts Receivable [Member] | Customer D [Member] | |||
Concentration risk | 0.00% | 72.00% | |
Accounts Receivable [Member] | All Others [Member] | |||
Concentration risk | 3.00% | 8.00% |
Note 2 - Investments and Fair_3
Note 2 - Investments and Fair Value Measurement (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | $ 0 | $ 0 | $ 0 |
Other than Temporary Impairment Losses, Investments, Available-for-sale Securities, Total | 0 | 0 | |
OCI, Debt Securities, Available-for-Sale, Transfer from Held-to-Maturity, Gain (Loss), before Adjustment, after Tax | $ 0 | $ 0 |
Note 2 - Investments and Fair_4
Note 2 - Investments and Fair Value Measurement - Summary of Cash, Cash Equivalents and Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Amortized Cost | $ 42,886 | $ 66,137 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 42,886 | 66,137 |
Cash and Cash Equivalents [Member] | ||
Amortized Cost | 27,274 | 14,684 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 27,274 | 14,684 |
Cash and Cash Equivalents [Member] | Cash [Member] | ||
Amortized Cost | 5,181 | 1,957 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 5,181 | 1,957 |
Cash and Cash Equivalents [Member] | Money Market Funds [Member] | ||
Amortized Cost | 3,996 | 598 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 3,996 | 598 |
Cash and Cash Equivalents [Member] | Commercial Paper [Member] | ||
Amortized Cost | 18,097 | 12,129 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 18,097 | 12,129 |
Cash and Cash Equivalents [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 14,268 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 14,268 | |
Marketable Securities [Member] | ||
Amortized Cost | 15,612 | 51,453 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 15,612 | 51,453 |
Marketable Securities [Member] | Commercial Paper [Member] | ||
Amortized Cost | 9,794 | 27,131 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 9,794 | 27,131 |
Marketable Securities [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 5,818 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 5,818 | |
Marketable Securities [Member] | Corporate Debt Securities [Member] | ||
Amortized Cost | 10,054 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 10,054 |
Note 2 - Investments and Fair_5
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, 2020 | Dec. 31, 2019 |
Assets, fair value | $ 37,705 | $ 64,180 |
Liabilities, fair value | 246 | 437 |
Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 246 | 437 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 3,996 | 598 |
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 33,709 | 63,582 |
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | 0 |
Liabilities, fair value | 246 | 437 |
Fair Value, Inputs, Level 3 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 246 | 437 |
Money Market Funds [Member] | ||
Assets, fair value | 3,996 | 598 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 3,996 | 598 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 0 | 0 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | 0 |
U.S. Government Agency Securities [Member] | ||
Assets, fair value | 5,818 | 14,268 |
U.S. Government Agency Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | 0 |
U.S. Government Agency Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 5,818 | 14,268 |
U.S. Government Agency Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | 0 |
Commercial Paper [Member] | ||
Assets, fair value | 27,891 | 39,260 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | 0 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 27,891 | 39,260 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | $ 0 | 0 |
Corporate Debt Securities [Member] | ||
Assets, fair value | 10,054 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 10,054 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | $ 0 |
Note 2 - Investments and Fair_6
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, 2020 | Dec. 31, 2019 | |
Fair value, Beginning of period | $ 437 | $ 121 |
Change in fair value of contingent put option associated with the Loan Agreement | (191) | (121) |
Change in fair value of contingent put option associated with the Loan Agreement | 437 | |
Fair value, End of period | $ 246 | $ 437 |
Note 3 - Inventories, Net (Deta
Note 3 - Inventories, Net (Details Textual) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory Write-down | $ 0.7 | $ 1 |
Terminated Amended Agreements [Member] | ||
Inventory Write-down | 0.3 | |
DSUVIA [Member] | ||
Inventory Write-down | $ 0.4 |
Note 3 - Inventories, Net - Inv
Note 3 - Inventories, Net - Inventory Components (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Raw materials | $ 257 | $ 1,153 |
Work-in-process | 30 | 593 |
Finished goods | 1,339 | 1,549 |
Inventories | $ 1,626 | $ 3,295 |
Note 4 - Property and Equipme_3
Note 4 - Property and Equipment, Net (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Depreciation, Total | $ 1.1 | $ 0.9 | $ 0.5 |
Note 4 - Property and Equipme_4
Note 4 - Property and Equipment, Net - Components of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property and Equipment, Gross | $ 26,248 | $ 24,104 |
Less accumulated depreciation and amortization | (10,589) | (9,552) |
Property and equipment, net | 15,659 | 14,552 |
Laboratory Equipment [Member] | ||
Property and Equipment, Gross | 4,406 | 4,389 |
Leasehold Improvements [Member] | ||
Property and Equipment, Gross | 4,616 | 4,616 |
Computer Equipment and Software [Member] | ||
Property and Equipment, Gross | 1,724 | 1,749 |
Construction in Progress [Member] | ||
Property and Equipment, Gross | 14,101 | 11,949 |
Tooling [Member] | ||
Property and Equipment, Gross | 1,109 | 1,109 |
Furniture and Fixtures [Member] | ||
Property and Equipment, Gross | $ 292 | $ 292 |
Note 5 - Revenue From Contrac_3
Note 5 - Revenue From Contracts With Customers (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
May 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 17, 2015 | May 11, 2015 | |
Government Contract Receivable | $ 17,000 | ||||
Deferred Revenue, Noncurrent, Total | $ 3,100 | ||||
Deferred Revenue, Current, Total | 300 | ||||
Amended License Agreement [Member] | |||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | $ 194,500 | ||||
Contract with Customer, Liability, Liability Eliminated | $ 2,572 | $ 0 | |||
Amended License Agreement [Member] | Based upon Successful Regulatory and Product Development Efforts [Member] | |||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | 28,500 | ||||
Amended License Agreement [Member] | Based upon Net Sales Target Achievements [Member] | |||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | $ 166,000 | ||||
ZALVISO [Member] | |||||
Contract with Customer, Liability, Liability Eliminated | $ 2,600 |
Note 5 - Revenue From Contrac_4
Note 5 - Revenue From Contracts With Customers - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | $ 5,416 | $ 2,289 | $ 2,151 |
DSUVIA [Member] | |||
Revenue | 1,409 | 377 | 0 |
ZALVISO [Member] | |||
Revenue | 1,112 | 1,453 | 825 |
Product [Member] | |||
Revenue | 2,521 | 1,830 | 825 |
Department of Defense [Member] | |||
Revenue | 0 | 0 | 838 |
Non-cash Royalty [Member] | |||
Revenue | 242 | 312 | 289 |
Royalty [Member] | |||
Revenue | 81 | 104 | 96 |
Contract and Other Revenue [Member] | |||
Revenue | 2,572 | 43 | 103 |
Contract and Other Collaboration [Member] | |||
Revenue | $ 2,895 | $ 459 | $ 1,326 |
Note 5 - Revenue From Contrac_5
Note 5 - Revenue From Contracts With Customers - Changes in Contract Liabilities (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
May 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | $ 5,416 | $ 2,289 | $ 2,151 | |
ZALVISO [Member] | ||||
Contract Liabilities: Deferred Revenue | 3,244 | |||
Contract Liabilities: Deferred Revenue, Additions | 0 | |||
Contract Liabilities: Deferred Revenue, Deductions | (3,195) | |||
Contract Liabilities: Deferred Revenue | 49 | 3,244 | ||
Amounts included in contract liabilities at the beginning of the period: Performance obligations eliminated upon termination | $ 2,600 | |||
Revenue | 1,112 | 1,453 | $ 825 | |
Amended License Agreement [Member] | ||||
Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied | 623 | 315 | ||
Amounts included in contract liabilities at the beginning of the period: Performance obligations eliminated upon termination | 2,572 | 0 | ||
New activities in the period from performance obligations satisfied: Performance obligations satisfied | 488 | 1,181 | ||
Revenue | $ 3,683 | $ 1,496 |
Note 6 - Long-term Debt (Detail
Note 6 - Long-term Debt (Details Textual) - USD ($) | Aug. 01, 2019 | May 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Repayments of Long-term Debt, Total | $ 4,667,000 | $ 3,470,000 | $ 7,718,000 | ||
Interest Expense, Total | 3,305,000 | 2,535,000 | 2,217,000 | ||
Long-term Debt, Total | 21,875,000 | ||||
Amortization of Debt Discount (Premium) | 1,069,000 | 712,000 | 613,000 | ||
Leasehold Improvements [Member] | |||||
Capital Leases, Balance Sheet, Assets by Major Class, Net, Total | 1,700,000 | ||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 176,679 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.83 | ||||
Loan Agreement with Oxford Finance LLC [Member] | |||||
Long-term Debt, Total | 21,000,000 | 24,200,000 | |||
Loan Agreement with Oxford Finance LLC [Member] | |||||
Repayments of Long-term Debt, Total | $ 8,900,000 | ||||
Debt Instrument, Face Amount | 25,000,000 | ||||
Proceeds from Debt, Net of Issuance Costs and Repayment of Debt | $ 15,900,000 | ||||
Debt Instrument, Interest Rate, Base Percentage | 2.50% | ||||
Debt Instrument, Final Payment, Percentage of Aggregate Principal Amount | 5.00% | ||||
Prepayment Charge, Percentage of Outstanding Balance, After May 30, 2020, Before May 30, 2021 | 1.50% | ||||
Prepayment Charge, Percentage of Outstanding Balance, After May 30,2021 | 1.00% | ||||
Debt Instrument, Covenant, Minimum Required Unrestircted Cash | $ 5,000,000 | ||||
Debt Instrument, Minimum Indebtedness Amount with Acceleration Right | 250,000 | ||||
Loan Default Events, Trigger of Negative Impact of Government Approvals and Judgments | $ 500,000 | ||||
Debt Instrument, Default Additional Interest Rate | 5.00% | ||||
Fair Value of Contingent Put Option, Liability | 200,000 | ||||
Interest Expense, Debt, Total | 3,200,000 | 1,900,000 | |||
Amortization of Debt Discount (Premium) | 900,000 | 600,000 | |||
Loan Agreement with Oxford Finance LLC [Member] | Minimum [Member] | |||||
Net Unrestricted Cash Proceeds, Contingent Threshold for Interest Only Period of Loan | $ 45,000,000 | ||||
Loan Agreement with Oxford Finance LLC [Member] | London Interbank Offered Rate (LIBOR) [Member] | |||||
Debt Instrument, Basis Spread on Variable Rate | 6.75% | ||||
Hercules Loan and Security Agreement [Member] | |||||
Repayments of Long-term Debt, Total | $ 8,900,000 | ||||
Long-term Debt, Gross | 7,400,000 | ||||
Debt Instrument, Termination Fee | 1,300,000 | ||||
Gain (Loss) on Extinguishment of Debt, Total | $ (200,000) | ||||
Interest Expense, Total | 0 | $ 600,000 | $ 2,200,000 | ||
Site Readiness Agreement [Member] | |||||
Long-term Debt, Total | 865,000 | ||||
Debt Instrument, Periodic Payment, Principal | $ 500,000 | ||||
Total Obligation Under Leasehold Agreement | $ 800,000 | ||||
Debt Instrument, Interest Rate, Effective Percentage | 14.35% |
Note 6 - Long-term Debt - Balan
Note 6 - Long-term Debt - Balance of Future Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Long-term debt | $ 21,875 | |
Less: current portion | 8,735 | $ 4,630 |
Long-term debt, net of current portion | 13,140 | $ 20,517 |
Site Readiness Agreement [Member] | ||
Long-term debt | 865 | |
Less: current portion | 402 | |
Long-term debt, net of current portion | $ 463 |
Note 6 - Long-term Debt - Outst
Note 6 - Long-term Debt - Outstanding Future Payments of Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
2021 | $ 10,429 | |
2022 | 9,647 | |
2023 | 5,530 | |
Total payments | 25,606 | |
Less amount representing interest | (2,523) | |
Notes payable, gross | 23,083 | |
Less: Unamortized portion of EOT Fee | (524) | |
Less: Unamortized discount on notes payable | (684) | |
Long-term debt | 21,875 | |
Less current portion | (8,735) | $ (4,630) |
Long-term debt, net of current portion | $ 13,140 | $ 20,517 |
Note 7 - Leases (Details Textua
Note 7 - Leases (Details Textual) - USD ($) | Jan. 02, 2019 | Dec. 12, 2012 | Jun. 30, 2017 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Feb. 16, 2019 |
Lessee, Operating Lease, Renewal Term (Year) | 2 years | 6 years | |||||
Lessee, Operating Lease, Monthly Rent | $ 100,000 | ||||||
Lessee, Operating Lease, Annual Rent Increase | 3.00% | ||||||
Percentage of Office and Laboratory Space Sublease | 47.00% | ||||||
Lessee, Operating Sublease Monthly Rent | $ 48,000 | ||||||
Lessee, Operating Sublease, Annual Rent Increase | 3.00% | ||||||
Lessee, Operating Sublease, Direct Costs | $ 400,000 | ||||||
Lessee, Operating Sublease, Initial Tenant Incentive Allowance Transfered from Operating Lease | 200,000 | $ 0 | $ 242,000 | ||||
Increase (Decrease) in Operating Lease Liabilities | $ (24,000) | $ (886,000) | $ (701,000) | $ 0 | |||
Lessee, Operating Lease, Notice Period (Month) | 18 months | ||||||
Lessee, Operating Lease, Annual Overhead Fee Payments | $ 200,000 |
Note 7 - Leases - Operating Lea
Note 7 - Leases - Operating Lease Costs (Details) - USD ($) $ in Thousands | Jan. 02, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Operating lease costs | $ 1,360 | $ 1,360 | |
Sublease income | (598) | (596) | |
Net lease costs | 762 | 764 | |
Operating cash flows used for operating leases | 1,268 | 1,084 | |
Lessee, Operating Sublease, Initial Tenant Incentive Allowance Transfered from Operating Lease | $ 200 | 0 | 242 |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 0 | $ 4,730 | |
Weighted-average remaining lease term – operating leases (years) (Year) | 3 years 1 month 6 days | 4 years 1 month 6 days | |
Weighted-average remaining discount rate – operating leases | 11.70% | 11.70% |
Note 7 - Leases - Maturities of
Note 7 - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
2021 | $ 1,504 | |
2022 | 1,445 | |
2023 | 1,386 | |
2024 | 116 | |
Total future minimum lease payments | 4,451 | |
Less imputed interest | (727) | |
Total | 3,724 | |
Operating lease liabilities | 1,118 | $ 970 |
Operating lease liabilities, net of current portion | 2,606 | $ 3,640 |
Total lease liability | $ 3,724 |
Note 7 - Leases - Future Minimu
Note 7 - Leases - Future Minimum Sublease Payments (Details) $ in Thousands | Dec. 31, 2020USD ($) |
2021 | $ 610 |
2022 | 629 |
2023 | 648 |
2024 | 54 |
Total future minimum sublease payments | 1,941 |
Rent receivable | 354 |
Prepaid Expenses and Other Current Assets [Member] | |
Rent receivable | 96 |
Other Assets [Member] | |
Rent receivable | $ 258 |
Note 8 - Liability Related to_3
Note 8 - Liability Related to Sale of Future Royalties (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Sep. 18, 2015 | Sep. 30, 2015 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Proceeds From Sale of Royalty and Milestone Rights | $ 65 | $ 65 | ||||||
Royalty Arrangment Maximum Payments | $ 195 | $ 195 | ||||||
Prospective Average Rate for Remaining Term of the Agreement | 4.20% | |||||||
Contingent Gain (Loss) on Royalty Monetization Arrangement | $ 65 | |||||||
Effective Interest Over Life of Liability Related to Sale of Future Royalties | 0.00% | |||||||
Net Income (Loss) from Change Estimate on Liability Related to Sale of Future Royalties | $ 8.1 | |||||||
Net Income (Loss) Per Share, Change Estimate on Liability Related to Sale of Future Royalties (in dollars per share) | $ 0.10 | |||||||
Effective Annual Interest Rate | 3.60% | 1.40% | 11.60% | |||||
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 | $ 43.5 | |||||||
MAA Approval [Member] | ||||||||
Revenue Recognition Milestone Method Agreed, Additional Amount | 15 | |||||||
PDL [Member] | ||||||||
Proceeds From Sale of Royalty and Milestone Rights | $ 61.2 | |||||||
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 | $ 35.6 | |||||||
AcelRX [Member] | First Four Commercial Milestones [Member] | ||||||||
Commercial Milestones Value Maximum Amount Available | $ 44.5 |
Note 8 - Liability Related to_4
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 | 63 Months Ended | ||
Sep. 30, 2015 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2020 | |
Liability related to sale of future royalties — beginning balance | $ 92,035 | $ 0 | |||
Proceeds from sale of future royalties | $ 61,200 | 0 | 61,184 | ||
Non-cash royalty revenue | (254) | (938) | |||
Non-cash interest (income) expense recognized | (3,310) | $ (1,337) | $ 10,341 | 28,225 | |
Liability related to sale of future royalties as of December 31, 2020 | 88,471 | 92,035 | 88,471 | ||
Less: current portion | (106) | (352) | (106) | ||
Liability related to sale of future royalties — net of current portion | $ 88,365 | $ 91,683 | $ 88,365 |
Note 9 - Warrants (Details Text
Note 9 - Warrants (Details Textual) - Warrant In Connection with Oxford Finance Loan Agreement [Member] $ in Millions | Dec. 31, 2020shares | May 30, 2019USD ($)$ / sharesyrshares |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 176,679 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.83 | |
Warrants and Rights Outstanding, Term (Year) | 10 years | |
Warrants and Rights Outstanding | $ | $ 0.4 | |
Class of Warrant or Right, Outstanding (in shares) | shares | 176,679 | |
Measurement Input, Exercise Price [Member] | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.83 | |
Measurement Input, Share Price [Member] | ||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 2.66 | |
Measurement Input, Expected Term [Member] | ||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | yr | 10 | |
Measurement Input, Risk Free Interest Rate [Member] | ||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.0222 | |
Measurement Input, Price Volatility [Member] | ||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.8022 | |
Measurement Input, Expected Dividend Rate [Member] | ||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0 |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity (Details Textual) - USD ($) | Mar. 04, 2021 | Jan. 27, 2021 | Jan. 27, 2021 | Jan. 22, 2021 | Dec. 11, 2020 | Jul. 23, 2020 | Jun. 16, 2020 | May 09, 2019 | Jun. 21, 2016 | Jan. 31, 2011 | Mar. 15, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2011 |
Proceeds from Issuance of Common Stock | $ 21,337,000 | $ 1,233,000 | $ 81,525,000 | ||||||||||||
Employee Stock Purchase Plan, Shares Issued, Weighted Average Fair Value (in dollars per share) | $ 1.09 | $ 2.33 | $ 1.51 | ||||||||||||
2011 Equity Incentive Plan [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other Than Options, Outstanding (in shares) | 1.9 | ||||||||||||||
Stock Option Plan Option Reserve Annual Increase as Percentage of Outstanding Shares Allowed | 4.00% | ||||||||||||||
The 2020 Equity Incentive Plan [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 5,500,000 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 6,012,971 | ||||||||||||||
The 2020 Equity Incentive Plan [Member] | Maximum [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares to be Added (in shares) | 14,892,170 | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period (Year) | 10 years | ||||||||||||||
Employee Stock Purchase Plan (ESPP) [Member] | |||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 4,900,000 | 340,128 | |||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 4,754,323 | ||||||||||||||
Private Placement [Member] | Armistice Capital and Rock Springs Capital [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 8,333,333 | 9,433,962 | |||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.20 | $ 1.06 | |||||||||||||
Proceeds from Issuance of Common Stock | $ 9,900,000 | $ 10,000,000 | |||||||||||||
Estimated Offering Costs | $ 51,000 | $ 49,000 | |||||||||||||
ATM Agreement [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 876,800 | 500,000 | 4,400,000 | ||||||||||||
Aggregate Offering Price, Maximum | $ 80,000,000 | $ 40,000,000 | $ 43,800,000 | ||||||||||||
Aggregate Offering Price, Increase During Period | $ 40,000,000 | ||||||||||||||
Proceeds from Issuance of Common Stock, Net | $ 1,400,000 | $ 1,200,000 | $ 16,800,000 | ||||||||||||
Payments of Stock Issuance Costs | $ 32,000 | $ 400,000 | |||||||||||||
ATM Agreement [Member] | Subsequent Event [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,000,000 | ||||||||||||||
Aggregate Offering Price, Maximum | $ 36,200,000 | ||||||||||||||
Proceeds from Issuance of Common Stock, Net | $ 7,400,000 | ||||||||||||||
Underwritten Public Offering [Member] | Subsequent Event [Member] | |||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 16,675,000 | 2,175,000 | 14,500,000 | ||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.7625 | $ 1.7625 | $ 1.7625 | ||||||||||||
Proceeds from Issuance of Common Stock, Net | $ 28,900,000 |
Note 12 - Stock-based Compens_3
Note 12 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 0.92 | $ 1.83 | $ 1.62 |
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 3,800 | ||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 1 month 6 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 3,600 | $ 4,400 | $ 4,900 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 0 | $ 100 | $ 200 |
The 2020 Equity Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 6,012,971 |
Note 12 - Stock-based Compens_4
Note 12 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock-based compensation expense | $ 4,424 | $ 5,057 | $ 5,168 |
Cost of Sales [Member] | |||
Stock-based compensation expense | 123 | 260 | 358 |
Research and Development Expense [Member] | |||
Stock-based compensation expense | 764 | 920 | 1,970 |
Selling, General and Administrative Expenses [Member] | |||
Stock-based compensation expense | $ 3,537 | $ 3,877 | $ 2,840 |
Note 12 - Stock-based Compens_5
Note 12 - Stock-based Compensation - Restricted Stock Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Restricted stock units outstanding (in shares) | 988,645 | 0 |
Restricted stock units weighted average outstanding (in dollars per share) | $ 2.53 | $ 0 |
Granted (in shares) | 908,300 | 1,029,085 |
Weighted average grant date fair value, granted (in dollars per share) | $ 1.30 | $ 2.53 |
Vested (in shares) | (304,810) | 0 |
Weighted average grant date fair value, vested (in dollars per share) | $ 2.53 | $ 0 |
Forfeited (in shares) | (194,152) | (40,440) |
Weighted average grant date fair value, forfeited (in dollars per share) | $ 2.16 | $ 2.54 |
Restricted stock units outstanding (in shares) | 1,397,983 | 988,645 |
Restricted stock units weighted average outstanding (in dollars per share) | $ 1.79 | $ 2.53 |
Note 12 - Stock-based Compens_6
Note 12 - Stock-based Compensation - Option Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($)$ / sharesshares | |
Outstanding (in shares) | shares | 12,648,739 |
Outstanding (in dollars per share) | $ / shares | $ 3.47 |
Granted (in shares) | shares | 1,816,596 |
Granted, weighted-average exercise price (in dollars per share) | $ / shares | $ 1.30 |
Forfeited (in shares) | shares | (610,518) |
Forfeited, weighted-average exercise price (in dollars per share) | $ / shares | $ 2.38 |
Expired (in shares) | shares | (1,041,795) |
Expired, weighted-average exercise price (in dollars per share) | $ / shares | $ 3.68 |
Exercised (in shares) | shares | 0 |
Exercised, weighted-average exercise price (in dollars per share) | $ / shares | $ 0 |
Outstanding (in shares) | shares | 12,813,022 |
Outstanding, weighted-average exercise price (in dollars per share) | $ / shares | $ 3.20 |
Outstanding, weighted-average remaining contractual life (Year) | 6 years 1 month 6 days |
Outstanding, aggregate intrinsic value | $ | $ 298 |
Vested and exercisable options (in shares) | shares | 9,536,806 |
Vested and exercisable options, weighted-average exercise price (in dollars per share) | $ / shares | $ 3.66 |
Vested and exercisable options, weighted-average remaining contractual life (Year) | 5 years 2 months 12 days |
Vested and exercisable options, aggregate intrinsic value | $ | $ 0 |
Vested and expected to vest (in shares) | shares | 12,813,022 |
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ / shares | $ 3.20 |
Vested and expected to vest, weighted-average remaining contractual life (Year) | 6 years 1 month 6 days |
Vested and expected to vest, aggregate intrinsic value | $ | $ 298 |
Note 12 - Stock-based Compens_7
Note 12 - Stock-based Compensation - Stock Options Outstanding, Vested and Exercisable (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Stock Options Outstanding (in shares) | 12,813,022 | 12,648,739 |
Weighted-average Remaining Contractual LIfe (Year) | 6 years 1 month 6 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 3.20 | $ 3.47 |
Shares Subject to Stock Options (in shares) | 9,536,806 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 3.66 | |
Exercise Price Range 1 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 0.84 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 1.31 | |
Number of Stock Options Outstanding (in shares) | 752,276 | |
Weighted-average Remaining Contractual LIfe (Year) | 9 years 2 months 12 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 0.84 | |
Shares Subject to Stock Options (in shares) | 0 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 0 | |
Exercise Price Range 2 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 1.43 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 2.15 | |
Number of Stock Options Outstanding (in shares) | 2,549,458 | |
Weighted-average Remaining Contractual LIfe (Year) | 7 years 9 months 18 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 1.88 | |
Shares Subject to Stock Options (in shares) | 1,148,695 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 2 | |
Exercise Price Range 3 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 2.19 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 3.29 | |
Number of Stock Options Outstanding (in shares) | 5,216,124 | |
Weighted-average Remaining Contractual LIfe (Year) | 6 years 8 months 12 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 2.69 | |
Shares Subject to Stock Options (in shares) | 4,174,021 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 2.71 | |
Exercise Price Range 4 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 3.30 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 4.95 | |
Number of Stock Options Outstanding (in shares) | 2,481,883 | |
Weighted-average Remaining Contractual LIfe (Year) | 4 years 3 months 18 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 3.51 | |
Shares Subject to Stock Options (in shares) | 2,400,809 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 3.51 | |
Exercise Price Range 5 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 5.31 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 7.97 | |
Number of Stock Options Outstanding (in shares) | 1,286,781 | |
Weighted-average Remaining Contractual LIfe (Year) | 2 years 8 months 12 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 5.75 | |
Shares Subject to Stock Options (in shares) | 1,286,781 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 5.75 | |
Exercise Price Range 6 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 8.18 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 12.27 | |
Number of Stock Options Outstanding (in shares) | 526,500 | |
Weighted-average Remaining Contractual LIfe (Year) | 3 years 1 month 6 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 10.28 | |
Shares Subject to Stock Options (in shares) | 526,500 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 10.28 |
Note 12 - Stock-based Compens_8
Note 12 - Stock-based Compensation - Assumptions to Calculate Fair Value of Each Employee Stock Option (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Expected term (Year) | 6 years 2 months 12 days | 6 years | 5 years 10 months 24 days |
Expected volatility | 83.00% | 85.00% | 83.00% |
Expected dividend rate | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Risk-free interest rate | 0.40% | 1.50% | 2.50% |
Maximum [Member] | |||
Risk-free interest rate | 1.50% | 2.50% | 3.10% |
Note 13 - Net Loss Per Share _3
Note 13 - 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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
RSU's, ESPP, and Employee Stock Options [Member] | |||
Antidilutive securities (in shares) | 14,541,005 | 13,798,797 | 11,797,960 |
Warrant [Member] | |||
Antidilutive securities (in shares) | 176,679 | 176,679 | 0 |
Note 14 - Accrued Liabilities -
Note 14 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued compensation and employee benefits | $ 3,293 | $ 3,796 |
Inventory and other contract manufacturing accruals | 137 | 752 |
Other accrued liabilities | 1,460 | 980 |
Total accrued liabilities | $ 4,890 | $ 5,528 |
Note 15 - 401(k) Plan (Details
Note 15 - 401(k) Plan (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Defined Contribution Plan, Employer Discretionary Contribution Percentage | 4.00% | ||
Contributions by Employer to Postemployment Benefit Obligations | $ 0.5 | $ 0.5 | $ 0.3 |
Note 16 - Income Taxes (Details
Note 16 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Expense (Benefit), Total | $ 4 | $ 3 | $ 2 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 11,400 | 12,900 | 9,900 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | $ 0 | $ 0 | $ 0 |
Open Tax Year | 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2016 2017 2018 2019 2020 | ||
Subject to Expiration [Member] | |||
Operating Loss Carryforwards, Total | $ 1,400 | ||
Research Tax Credit Carryforward [Member] | Subject to Expiration [Member] | |||
Tax Credit Carryforward, Amount | 26 | ||
Domestic Tax Authority [Member] | |||
Operating Loss Carryforwards, Total | 264,400 | ||
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | 6,500 | ||
Domestic Tax Authority [Member] | Before Tax Year 2018 [Member] | |||
Operating Loss Carryforwards, Total | 114,900 | ||
Domestic Tax Authority [Member] | Tax Years 2018 to 2020 [Member] | |||
Operating Loss Carryforwards, Total | 149,500 | ||
State and Local Jurisdiction [Member] | |||
Operating Loss Carryforwards, Total | 141,500 | ||
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | |||
Tax Credit Carryforward, Amount | $ 4,000 |
Note 16 - Income Taxes - Net De
Note 16 - Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accruals and other | $ 4,136 | $ 3,672 |
Research credits | 7,275 | 7,275 |
Net operating loss carryforward | 65,274 | 52,361 |
Section 59(e) R&D expenditures | 7,473 | 8,933 |
Deferred revenue | 20,848 | 21,324 |
Total deferred tax assets | 105,006 | 93,565 |
Valuation allowance | (105,006) | (93,565) |
Net deferred tax assets | $ 0 | $ 0 |
Note 16 - Income Taxes - Reconc
Note 16 - Income Taxes - Reconciliation of Statutory Federal Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Tax at statutory federal rate | $ (8,486) | $ (11,180) | $ (9,901) |
State tax—net of federal benefit | (3,587) | (2,538) | (792) |
General business credits | 0 | 0 | (500) |
Stock options | 636 | 800 | 1,048 |
Other | 0 | 7 | 295 |
Change in valuation allowance | 11,441 | 12,914 | 9,852 |
Provision for income taxes | $ 4 | $ 3 | $ 2 |
Note 16 - Income Taxes - Reco_2
Note 16 - Income Taxes - Reconciliation of Beginning and Ending Balance of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Unrecognized benefit—beginning of period | $ 2,635 | $ 2,635 | $ 2,365 |
Gross increases—prior period tax positions | 0 | 0 | 57 |
Gross increases—current period tax positions | 0 | 0 | 213 |
Unrecognized benefit—end of period | $ 2,635 | $ 2,635 | $ 2,635 |
Note 17 - Subsequent Event (Det
Note 17 - Subsequent Event (Details Textual) - USD ($) $ / shares in Units, $ in Millions | Mar. 04, 2021 | Jan. 27, 2021 | Jan. 27, 2021 | Jan. 22, 2021 | May 09, 2019 | Jun. 21, 2016 | Mar. 15, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Underwritten Public Offering [Member] | Subsequent Event [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 16,675,000 | 2,175,000 | 14,500,000 | |||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.7625 | $ 1.7625 | $ 1.7625 | |||||||
Proceeds from Issuance of Common Stock, Net | $ 28.9 | |||||||||
ATM Agreement [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 876,800 | 500,000 | 4,400,000 | |||||||
Proceeds from Issuance of Common Stock, Net | $ 1.4 | $ 1.2 | $ 16.8 | |||||||
Aggregate Offering Price, Maximum | $ 80 | $ 40 | $ 43.8 | |||||||
ATM Agreement [Member] | Subsequent Event [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,000,000 | |||||||||
Proceeds from Issuance of Common Stock, Net | $ 7.4 | |||||||||
Aggregate Offering Price, Maximum | $ 36.2 |
Schedule II - Valuation and Q_3
Schedule II - Valuation and Qualifying Accounts - Valuation and Qualifying Accounts (Details) - SEC Schedule, 12-09, Allowance, Sales and Returns, Discounts, Chargebacks and Rebates [Member] - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | ||
Balance | $ 161 | $ 0 | $ 0 | |
Additions | 645 | 201 | 0 | |
Deductions | [1] | (138) | (40) | 0 |
Balance | $ 668 | $ 161 | $ 0 | |
[1] | Deductions to sales discounts and allowances relate to discounts or allowances actually taken or paid. |