Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 24, 2019 | |
Document Information [Line Items] | ||
Entity Registrant Name | ACELRX PHARMACEUTICALS INC | |
Entity Central Index Key | 0001427925 | |
Trading Symbol | acrx | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Current Reporting Status | Yes | |
Entity Emerging Growth Company | false | |
Entity Small Business | true | |
Entity Common Stock, Shares Outstanding (in shares) | 79,435,542 | |
Entity Shell Company | false | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Title of 12(b) Security | Common Stock |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | |
Assets | |||
Cash and cash equivalents | $ 65,071 | $ 87,975 | [1] |
Short-term investments | 26,475 | 17,740 | [1] |
Accounts receivable, net | 221 | 49 | [1] |
Tax receivable | 352 | 352 | [1] |
Inventories | 2,844 | 854 | [1] |
Prepaid expenses and other current assets | 1,855 | 1,024 | [1] |
Total current assets | 96,818 | 107,994 | [1] |
Operating lease right-of-use assets | 4,326 | [1] | |
Property and equipment, net | 12,598 | 11,483 | [1] |
Long-term tax receivable | 351 | 351 | [1] |
Other assets | 1,019 | 705 | [1] |
Total Assets | 115,112 | 120,533 | [1] |
Liabilities and Stockholders’ (Deficit) Equity | |||
Accounts payable | 2,334 | 2,070 | [1] |
Accrued liabilities | 4,276 | 4,540 | [1] |
Long-term debt, current portion | 8,611 | [1] | |
Deferred revenue, current portion | 324 | 315 | [1] |
Operating lease liabilities, current portion | 759 | [1] | |
Liability related to the sale of future royalties, current portion | 592 | 392 | [1] |
Total current liabilities | 8,285 | 15,928 | [1] |
Long-term debt, net of current portion | 23,770 | 3,380 | [1] |
Deferred revenue, net of current portion | 2,990 | 3,148 | [1] |
Operating lease liabilities, net of current portion | 4,239 | [1] | |
Liability related to the sale of future royalties, net of current portion | 93,537 | 93,287 | [1] |
Other long-term liabilities | 710 | 537 | [1] |
Total liabilities | 133,531 | 116,280 | [1] |
Commitments and Contingencies | |||
Stockholders’ (Deficit) Equity: | |||
Common stock, $0.001 par value—200,000,000 shares authorized as of June 30, 2019 and December 31, 2018; 78,914,170 and 78,757,930 shares issued and outstanding as of June 30, 2019 and December 31, 2018 | 79 | 78 | [1] |
Additional paid-in capital | 352,454 | 349,194 | [1] |
Accumulated deficit | (370,952) | (345,019) | |
Total stockholders’ (deficit) equity | (18,419) | 4,253 | |
Total Liabilities and Stockholders’ (Deficit) Equity | $ 115,112 | $ 120,533 | [1] |
[1] | The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
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) | 78,914,170 | 78,757,930 |
Common stock, outstanding (in shares) | 78,914,170 | 78,757,930 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Revenue: | ||||
Revenue | $ 941 | $ 818 | $ 1,206 | $ 1,161 |
Operating costs and expenses: | ||||
Cost of goods sold | 1,810 | 749 | 3,040 | 1,863 |
Research and development | 1,163 | 3,278 | 2,540 | 6,791 |
Selling, general and administrative | 11,329 | 3,944 | 21,305 | 7,929 |
Total operating costs and expenses | 14,302 | 7,971 | 26,885 | 16,583 |
Loss from operations | (13,361) | (7,153) | (25,679) | (15,422) |
Other income (expense): | ||||
Interest expense | (500) | (586) | (876) | (1,229) |
Interest income and other income (expense), net | 456 | 195 | 1,083 | 331 |
Non-cash interest income (expense) on liability related to future sale of royalties | 996 | (2,995) | (611) | (5,811) |
Total other income (expense) | 952 | (3,386) | (404) | (6,709) |
Net loss before income taxes | (12,409) | (10,539) | (26,083) | (22,131) |
Provision for income taxes | (3) | (2) | (3) | (2) |
Net loss | (12,412) | (10,541) | (26,086) | (22,133) |
Comprehensive loss | $ (12,412) | $ (10,541) | $ (26,086) | $ (22,133) |
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.16) | $ (0.20) | $ (0.33) | $ (0.43) |
Shares used in computing net loss per share of common stock, basic and diluted (in shares) | 78,902,470 | 51,841,550 | 78,845,944 | 51,388,762 |
Product [Member] | ||||
Revenue: | ||||
Revenue | $ 55 | $ 102 | ||
Collaboration Agreement Revenue [Member] | ||||
Revenue: | ||||
Revenue | 886 | 351 | 1,104 | 625 |
Contract and Other [Member] | ||||
Revenue: | ||||
Revenue | $ 467 | $ 536 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2017 | 50,899,154 | ||||
Balance at Dec. 31, 2017 | $ 51 | $ 261,310 | $ (297,870) | $ (36,509) | |
Stock-based compensation | 1,080 | 1,080 | |||
Issuance of common stock upon ESPP purchase (in shares) | 92,290 | ||||
Issuance of common stock upon ESPP purchase | 141 | 141 | |||
Net loss | (11,592) | (11,592) | |||
Balance (in shares) at Mar. 31, 2018 | 50,991,444 | ||||
Balance at Mar. 31, 2018 | $ 51 | 262,531 | (309,462) | (46,880) | |
Balance (in shares) at Dec. 31, 2017 | 50,899,154 | ||||
Balance at Dec. 31, 2017 | $ 51 | 261,310 | (297,870) | (36,509) | |
Net loss | (22,133) | ||||
Balance (in shares) at Jun. 30, 2018 | 53,327,187 | ||||
Balance at Jun. 30, 2018 | $ 53 | 270,984 | (320,003) | (48,966) | |
Balance (in shares) at Mar. 31, 2018 | 50,991,444 | ||||
Balance at Mar. 31, 2018 | $ 51 | 262,531 | (309,462) | (46,880) | |
Stock-based compensation | 1,048 | 1,048 | |||
Net loss | (10,541) | (10,541) | |||
Issuance of common stock in connection with equity financings (in shares) | 2,335,743 | ||||
Issuance of common stock in connection with equity financings | $ 2 | 7,405 | 7,407 | ||
Balance (in shares) at Jun. 30, 2018 | 53,327,187 | ||||
Balance at Jun. 30, 2018 | $ 53 | 270,984 | (320,003) | (48,966) | |
Balance (in shares) at Dec. 31, 2018 | 78,757,930 | ||||
Balance at Dec. 31, 2018 | $ 78 | 349,194 | (345,019) | 4,253 | |
Cumulative effect adjustment for adoption of ASU No. 2016-02 (Accounting Standards Update 2016-02 [Member]) at Dec. 31, 2018 | 153 | 153 | |||
Stock-based compensation | 1,107 | 1,107 | |||
Issuance of common stock upon exercise of stock options (in shares) | 13,583 | ||||
Issuance of common stock upon exercise of stock options | 31 | 31 | |||
Issuance of common stock upon ESPP purchase (in shares) | 85,135 | ||||
Issuance of common stock upon ESPP purchase | $ 1 | 238 | 239 | ||
Net loss | (13,674) | (13,674) | |||
Balance (in shares) at Mar. 31, 2019 | 78,856,648 | ||||
Balance at Mar. 31, 2019 | $ 79 | 350,570 | (358,540) | (7,891) | |
Balance (in shares) at Dec. 31, 2018 | 78,757,930 | ||||
Balance at Dec. 31, 2018 | $ 78 | 349,194 | (345,019) | 4,253 | |
Cumulative effect adjustment for adoption of ASU No. 2016-02 (Accounting Standards Update 2016-02 [Member]) at Dec. 31, 2018 | 153 | 153 | |||
Net loss | (26,086) | ||||
Balance (in shares) at Jun. 30, 2019 | 78,914,170 | ||||
Balance at Jun. 30, 2019 | $ 79 | 352,454 | (370,952) | (18,419) | |
Balance (in shares) at Mar. 31, 2019 | 78,856,648 | ||||
Balance at Mar. 31, 2019 | $ 79 | 350,570 | (358,540) | (7,891) | |
Stock-based compensation | 1,346 | 1,346 | |||
Issuance of common stock upon exercise of stock options (in shares) | 57,522 | ||||
Issuance of common stock upon exercise of stock options | 155 | 155 | |||
Net loss | (12,412) | (12,412) | |||
Issuance of warrants related to debt financing | 383 | 383 | |||
Balance (in shares) at Jun. 30, 2019 | 78,914,170 | ||||
Balance at Jun. 30, 2019 | $ 79 | $ 352,454 | $ (370,952) | $ (18,419) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | 45 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | |
Cash flows from operating activities: | |||||||
Net loss | $ (12,412,000) | $ (13,674,000) | $ (10,541,000) | $ (11,592,000) | $ (26,086,000) | $ (22,133,000) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Non-cash royalty revenue related to royalty monetization | (118,000) | (155,000) | |||||
Non-cash interest (income) expense on liability related to royalty monetization | (996,000) | 2,995,000 | 611,000 | 5,811,000 | $ 33,483,000 | ||
Depreciation and amortization | 734,000 | 293,000 | |||||
Non-cash interest expense related to debt financing | 234,000 | 344,000 | |||||
Stock-based compensation | 2,453,000 | 2,128,000 | |||||
Other | (212,000) | (79,000) | |||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (172,000) | 760,000 | |||||
Inventories | (1,990,000) | 293,000 | |||||
Prepaid expenses and other assets | (632,000) | (561,000) | |||||
Other assets | (314,000) | ||||||
Accounts payable | 559,000 | 469,000 | |||||
Accrued liabilities | (164,000) | (837,000) | |||||
Operating lease liabilities | (313,000) | ||||||
Deferred rent | 65,000 | ||||||
Deferred revenue | (149,000) | (182,000) | |||||
Net cash used in operating activities | (25,559,000) | (13,784,000) | |||||
Cash flows from investing activities: | |||||||
Purchase of property and equipment | (1,790,000) | (387,000) | |||||
Purchase of investments | (28,156,000) | (12,844,000) | |||||
Proceeds from maturities of investments | 19,700,000 | 3,600,000 | |||||
Net cash used in investing activities | (10,246,000) | (9,631,000) | |||||
Cash flows from financing activities: | |||||||
Proceeds from issuance of long-term debt | 25,000,000 | ||||||
Payment of costs in connection with refinancing of long-term debt | (190,000) | ||||||
Payment of long-term debt | (3,470,000) | (3,762,000) | |||||
Extinguishment of debt | (8,864,000) | ||||||
Net proceeds from issuance of common stock in connection with equity financings | 7,407,000 | ||||||
Net proceeds from issuance of common stock through equity plans | 425,000 | 141,000 | |||||
Net cash provided by financing activities | 12,901,000 | 3,786,000 | |||||
Net decrease in cash and cash equivalents | (22,904,000) | (19,629,000) | |||||
Cash and cash equivalents—Beginning of period | $ 87,975,000 | $ 52,902,000 | 87,975,000 | 52,902,000 | |||
Cash and cash equivalents—End of period | $ 65,071,000 | $ 33,273,000 | $ 65,071,000 | $ 33,273,000 | $ 65,071,000 |
Note 1 - Organization and Summa
Note 1 - Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 1. AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on July 13, 2005 as SuRx, Inc., and in January 2006, the Company changed its name to AcelRx Pharmaceuticals, Inc. The Company’s operations are based in Redwood City, California. AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA ® (known as DZUVEO in Europe) and Zalviso ® , are both focused on the treatment of acute pain, and each utilize sufentanil, delivered via a non-invasive route of sublingual administration, exclusively for use in medically supervised settings. On November 2, 2018, the U.S. Food and Drug Administration, or FDA, approved DSUVIA for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. In June 2018, the European Commission, or EC, granted marketing approval of DZUVEO for the treatment of patients with moderate-to-severe acute pain in medically monitored settings. AcelRx is further developing a distribution capability and commercial organization to continue to market and sell DSUVIA in the United States. The commercial launch of DSUVIA in the United States occurred in the first quarter of 2019. In geographies where AcelRx decides not to commercialize products by itself, including for DZUVEO in Europe, the Company may seek to out-license commercialization rights. The Company currently intends to commercialize and promote DSUVIA/DZUVEO outside the United States with one or more strategic partners, although it has not yet entered into any such arrangement. The Company is currently evaluating the timing of the resubmission of the new drug application, or NDA, for Zalviso. AcelRx intends to seek regulatory approval for Zalviso in the United States and, if successful, potentially promote Zalviso either by itself or with strategic partners. Zalviso is approved in Europe and is currently being commercialized by Grünenthal GmbH, or Grünenthal. DSUVIA /DZUVEO DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018, is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator, or SDA, by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous, or IV, and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The EC approved DZUVEO for marketing in Europe in 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 will only be 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 will need to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA will not be available in retail pharmacies or for outpatient use. As part of the REMS program, the Company will monitor distribution and audit wholesalers’ data, evaluate proper usage within the healthcare settings and monitor for any diversion and abuse. Additionally, AcelRx will de-certify healthcare settings that are non-compliant with the REMS program. Zalviso Zalviso delivers 15 mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia, or PCA, system. Zalviso is approved in Europe and is in late-stage development in the United States. The Company had initially submitted to the FDA an NDA seeking approval for Zalviso in September 2013 but received a complete response letter, or CRL, on July 25, 2014. Subsequently, the FDA requested an additional clinical study, IAP312, designed to evaluate the effectiveness of changes made to the functionality and usability of the Zalviso device and to take into account comments from the FDA on the study protocol. In the IAP312 study, for which top-line results were announced in August 2017, Zalviso met safety, satisfaction and device usability expectations. These results will supplement the three Phase 3 trials already completed in the Zalviso NDA resubmission. The Company is currently evaluating the timing of the NDA resubmission for Zalviso. On December 16, 2013, AcelRx and Grünenthal entered into a Collaboration and License Agreement, or the License Agreement, which was amended effective July 17, 2015 and September 20, 2016, or the Amended License Agreement, which grants Grünenthal rights to commercialize the Zalviso PCA system, or the Product, in the countries of the European Union, or EU, Switzerland, Liechtenstein, Iceland, Norway and Australia (collectively, the Territory) for human use in pain treatment within, or dispensed by, hospitals, hospices, nursing homes and other medically supervised settings, (collectively, the Field). In September 2015, the EC approved the marketing authorization application, or MAA, previously submitted to the EMA, for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. On December 16, 2013, AcelRx and Grünenthal, entered into a Manufacture and Supply Agreement, or the MSA, and together with the License Agreement, the Agreements. Under the MSA, the Company will exclusively manufacture and supply the Product to Grünenthal for the Field in the Territory. On July 22, 2015, the Company and Grünenthal amended the MSA, or the Amended MSA, effective as of July 17, 2015. The Amended MSA and the Amended License Agreement are referred to as the Amended Agreements. The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although Zalviso has been approved for sale in Europe, on September 18, 2015, the Company sold the majority of the royalty rights and certain commercial sales milestones it is entitled to receive under the Amended License Agreement with Grünenthal to PDL BioPharma, Inc., or PDL, in a transaction referred to as the Royalty Monetization. The FDA approved DSUVIA in November 2018 and the Company began its commercial launch of DSUVIA in the first quarter of 2019. As a result, the Company expects to continue to incur operating losses and negative cash flows until such time as DSUVIA has gained market acceptance and generated significant revenues. 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. Principles of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, ARPI LLC, which was formed in September 2015 for the sole purpose of facilitating the Royalty Monetization. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note 8 “Liability Related to Sale of Future Royalties” for additional information. Reclassifications Certain prior year amounts in the condensed consolidated financial statements have been reclassified to conform to the current year's presentation. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and the rules and regulations of the United States. Securities and Exchange Commission, or SEC. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2019, are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. The condensed consolidated balance sheet as of December 31, 2018, was derived from the Company’s audited financial statements as of December 31, 2018, included in the Company’s Annual Report on Form 10 -K filed with the SEC. These financial statements should be read in conjunction with the Company’s Annual Report on Form 10 -K for the year ended December 31, 2018, which includes a broader discussion of the Company’s business and the risks inherent therein. 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 condensed 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 readily apparent from other sources. Actual results could differ from those estimates. Inventories Inventories are valued at the lower of cost and net realizable value. Cost is determined using the first -in, first -out method for all inventories. Inventory includes the cost of the active pharmaceutical ingredients, or API, raw materials and third -party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are allocated to the appropriate cost pool and then absorbed into inventory based on the units produced or distributed, assuming normal capacity, in the applicable period. Indirect overhead costs in excess of normal capacity are recorded as period costs in the period incurred. DSUVIA was approved by the FDA in November 2018. Prior to FDA approval, all manufacturing costs for DSUVIA were expensed to research and development. Upon FDA approval, manufacturing costs for DSUVIA manufactured for commercial sale have been capitalized. The Company's policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or market approach as that used to value the inventory. Because the predetermined, contractual transfer prices the Company is receiving from Grünenthal are less than the direct costs of manufacturing, all Zalviso inventories are carried at net realizable value. Leases In February 2016, the FASB issued Accounting Standards Update, or ASU, No. 2016 - 02, Leases (Topic 842 ) , to enhance the transparency and comparability of financial reporting related to leasing arrangements. The Company adopted the standard effective 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 readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, the Company no longer recognizes deferred rent on the balance sheet. Revenue from Contracts with Customers Beginning January 1, 2018, the Company has followed the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers . The guidance provides a unified model to determine how revenue is recognized. The Company recognizes revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services. 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. Net product sales revenue 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, such as hospitals, surgical centers, and emergency departments. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and/or privately-negotiated discounts with respect to the purchase of its products. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of discounts, returns and GPO discounts and administrative fees. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. Variable consideration is estimated using the most-likely amount method, which is the single-most likely outcome under a contract and is typically at the stated contractual rate. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted. These items include: ● Distributor Fees – The Company offers contractually determined discounts to its Customers. These discounts are paid no later than two months after the quarter in which product was shipped. ● GPO Discounts - The Company offers discounts to GPO members. These discounts are taken when the GPO members purchase DSUVIA from the Company’s customers, who then charge the discount amount back to the Company. ● GPO Administrative Fees - The Company pays administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPOs’ members. ● Returns – The Company allows its Customers to return product for credit 12 months after its product expiration date. As such, there may be a significant period of time between the time the product is shipped and the time the credit is issued on returned product. The Company believes its estimated allowance for product returns requires a high degree of judgment and is subject to change based on its experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distributor fees, GPO discounts and administrative fees do not require a high degree of judgment because the amounts are settled within a relatively short period of time. Amounts accrued for product revenue allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate and to reflect actual experience. Product revenue-related liabilities are recorded in the Company’s condensed consolidated balance sheets as Accrued liabilities. The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust these estimates accordingly. Changes in sales allowance estimates could materially affect the Company’s results of operations and financial position. Collaboration agreement r evenue 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. Contract and other 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. The DoD Contract period of performance ended on February 28, 2019. 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’s performance obligations include delivering product to its distributors, commercialization license rights, development services, services associated with the regulatory approval process, joint steering committee services, demo devices, manufacturing services, material rights for discounts on manufacturing services, and product supply. 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 condensed 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 occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. 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 Revenues from product sales are recognized when distributors obtain control of the Company’s products, which occurs at a point in time, upon delivery to such distributors. 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 shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch up basis. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for products at a point in time when control of the product is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to in exchange for those product sales, which is typically once the product physically arrives at the customer, and for licenses of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that the Company has incurred to perform the services using the cost-to-cost input method. Cost of Goods Sold Cost of goods sold for product revenue includes third party manufacturing costs, shipping costs, and indirect overhead costs associated with production and distribution which are allocated to the appropriate cost pool and recognized when revenue is recognized. Indirect overhead costs in excess of normal capacity are recorded as period costs in the period incurred. Under the Amended Agreements with Grünenthal, the Company sells Zalviso to Grünenthal at predetermined, contractual transfer prices that are less than the direct costs of manufacturing and recognizes indirect costs as period costs where they are in excess of normal capacity and not realizable on a lower of cost or market basis. Cost of goods sold for Zalviso shipped to Grünenthal includes the inventory costs of API, third -party contract manufacturing costs, packaging and distribution costs, shipping, handling and storage costs, depreciation and costs of the employees involved with production. Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties In September 2015, the Company sold certain royalty and milestone payment rights from the sales of Zalviso in the European Union by its commercial partner, Grünenthal, pursuant to the Collaboration and License Agreement, dated as of December 16, 2013, as amended, to PDL for gross proceeds of $65.0 million, referred to as the Royalty Monetization. The Company continues to have significant continuing involvement in the Royalty Monetization primarily due to an obligation to supply Zalviso to Grünenthal. 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 estimates are updated related to the Royalty Monetization, accordingly. 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 within the Company’s control. Such factors include, but are not limited to, the success of Grünenthal’s sales and promotion of Zalviso, changing standards of care, the introduction of competing products, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of Zalviso, significant changes in foreign exchange rates as the royalties remitted to ARPI LLC are made in U.S. dollars, and other events or circumstances that could result in reduced royalty payments from European sales of Zalviso, all of which may result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the Royalty Monetization. Conversely, if sales of Zalviso in Europe are more than expected, the non-cash royalty revenues and the non-cash interest expense recorded by the Company would be greater over the term of the Royalty Monetization. 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 interest rate. Because estimated sales forecasts and payments may vary over the life of the Royalty Monetization, the Company may be required to recognize interest income as the imputed interest rate is adjusted prospectively to reflect the revised effective interest rate over the term of the Royalty Monetization. The Company records non-cash royalty revenues and non-cash interest income (expense), 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 million received, the Company defers recognition of any probable contingent gain until the Royalty Monetization liability expires. Significant Accounting Policies The Company’s significant accounting policies are detailed in its Annual Report on Form 10 December 31, 2018. No. 2016 02, Leases (Topic 842 7 no three six June 30, 2019, 2018 10 Recently Adopted Accounting Standards On August 29, 2018, the Financial Accounting Standards Board, or FASB, issued ASU No. 2018 - 15, “ Intangibles – Goodwill and Other – Internal Use Software (Subtopic 350 - 40 ) ” . The FASB’s new guidance aligns the requirements for capitalizing implementation costs in a Cloud Computing Arrangement, or CCA, service contract with the requirements for capitalizing implementation costs incurred for an internal-use software license. The amendments in ASU No. 2018 - 15 require the entity to present the expense related to the capitalized implementation costs in the same line item in the statement of income as the fees associated with the hosting element (service) of the arrangement and classify payments for capitalized implementation costs in the statement of cash flows in the same manner as payments made for fees associated with the hosting element. The entity is also required to present the capitalized implementation costs in the statement of financial position in the same line item that a prepayment for the fees of the associated hosting arrangement would be presented. ASU No. 2018 - 15 is effective for public business entities for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period for which financial statements have not been issued. Entities can choose to adopt the new guidance ( 1 ) prospectively to eligible costs incurred on or after the date this guidance is first applied or ( 2 ) retrospectively. The Company early adopted ASU No. 2018 - 15 effective January 1, 2019 under the prospective method, which did not have a material effect on the Company’s results of operations, financial condition or cash flows. In August 2018, the SEC published Release No. 33 - 10532, Disclosure Update and Simplification , or DUSTR, which adopted amendments to certain disclosure requirements that have become redundant, duplicative, overlapping, outdated or superseded, in light of other SEC disclosure requirements, U.S. Generally Accepted Accounting Principles, or GAAP, or changes in the information environment. While most of the DUSTR amendments eliminate outdated or duplicative disclosure requirements, the final rule amends the interim financial statement requirements to include a reconciliation of changes in stockholders’ equity (deficit) in the notes or as a separate statement for each period for which a statement of comprehensive income (loss) is required to be filed. The new interim reconciliation of changes in stockholders’ equity (deficit) is included herein as a separate statement. In February 2016, the FASB issued ASU No. 2016 - 02, Leases (Topic 842 ) , which establishes a new lease accounting model for lessees. In January, July and December 2018, the FASB issued additional amendments to the new lease guidance relating to, transition, and clarification. The July 2018 amendment, ASU No. 2018 - 11, Leases (Topic 842 ): Targeted Improvements , provided an optional transition method that allows entities to elect to apply the standard prospectively at its effective date, versus recasting the prior periods presented. The new standard establishes a right-of-use, or ROU, model that requires a l |
Note 2 - Investments and Fair V
Note 2 - Investments and Fair Value Measurement | 6 Months Ended |
Jun. 30, 2019 | |
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 June 30 , 201 9 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash and cash equivalents: Cash $ 3,018 $ — $ — $ 3,018 Money market funds 286 — — 286 Commercial paper 61,767 — — 61,767 Total cash and cash equivalents 65,071 — — 65,071 Short-term investments: Commercial paper $ 26,475 $ — $ — $ 26,475 Total cash, cash equivalents and investments $ 91,546 $ — $ — $ 91,546 As of December 31 , 201 8 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash and cash equivalents: Cash $ 2,037 $ — $ — $ 2,037 Money market funds 1,436 — — 1,436 U.S. government agency securities 10,181 — — 10,181 Commercial paper 74,321 — — 74,321 Total cash and cash equivalents 87,975 — — 87,975 Short-term investments: U.S. government agency securities $ 1,497 $ — $ — $ 1,497 Commercial paper 16,243 — — 16,243 Total marketable securities and commercial paper 17,740 — — 17,740 Total cash, cash equivalents and investments $ 105,715 $ — $ — $ 105,715 As of June 30, 2019 December 31, 2018, none no June 30, 2019 December 31, 2018. No no three six June 30, 2019 June 30, 2018. As of June 30, 2019 December 31, 2018, 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 June 30, 2019, December 31, 2018, 2014 1 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 June 30 , 2019 Fair Value Level I Level II Level III Assets Money market funds $ 286 $ 286 $ — $ — Commercial paper 88,242 — 88,242 — Total assets measured at fair value $ 88,528 $ 286 $ 88,242 $ — Liabilities Contingent put option liability $ 657 $ — $ — $ 657 Total liabilities measured at fair value $ 657 $ — $ — $ 657 As of December 31 , 201 8 Fair Value Level I Level II Level III Assets Money market funds $ 1,436 $ 1,436 $ — $ — U.S. government agency securities 11,678 — 11,678 — Commercial paper 90,564 — 90,564 — Total assets measured at fair value $ 103,678 $ 1,436 $ 102,242 $ — Liabilities Contingent put option liability $ 121 $ — $ — $ 121 Total liabilities measured at fair value $ 121 $ — $ — $ 121 The following tables set forth a summary of the changes in the fair value of the Company’s Level III financial liabilities for the three six June 30, 2019 June 30, 2018 ( Three Months 9 Six Months 9 Fair value—beginning of period $ 98 $ 121 Fair value of contingent put option associated with the Loan Agreement 657 657 Change in fair value of contingent put option associated with the Prior Agreement (98 ) (121 ) Fair value—end of period $ 657 $ 657 Three Months 8 Six Months 8 Fair value—beginning of period $ 186 $ 207 Change in fair value of contingent put option associated with the Prior Agreement (20 ) (41 ) Fair value—end of period $ 166 $ 166 |
Note 3 - Inventories
Note 3 - Inventories | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 3. Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value and consist of the following (in thousands): Balance as of June 30 , 2019 December 31, 201 8 Raw materials $ 1,422 $ 694 Work-in-process 273 160 Finished goods 1,149 — Total $ 2,844 $ 854 |
Note 4 - Revenue
Note 4 - Revenue | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 4 Revenue As described in Note 1 first 2019. June 30, 2019, $3.3 2029. 1 The following table presents changes in the Company’s contract liability for the six June 30, 2019: Balance at Beginning of the Period Additions Deductions Balance at the end of the Period (in thousands) Contract liability: Deferred revenue $ 3,463 $ 131 $ (280 ) $ 3,314 During the three six June 30, 2019, Three months ended June 30, 201 9 Six months ended June 30, 201 9 Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied – Amended Agreements $ 79 $ 158 New activities in the period from performance obligations satisfied: Performance obligations satisfied – Amended Agreements 649 677 Total revenue from performance obligations satisfied 728 835 Royalty revenue 158 269 Net product sales 55 102 Total revenue $ 941 $ 1,206 |
Note 5 - Collaboration Agreemen
Note 5 - Collaboration Agreement | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | 5 . Collaboration Agreement As described in Note 1 Amended License Agreement Under the Amended License Agreement, the Company is eligible to receive approximately $194.5 $28.5 $166.0 8 Amended MSA Under the terms of the Amended MSA, the Company will manufacture and supply the Product for use in the Field for the Territory exclusively for Grünenthal. The Product will be supplied at prices approximating the Company’s manufacturing cost, subject to certain caps, as defined in the MSA Amendment. The MSA Amendment requires the Company to use commercially reasonable efforts to enter stand-by contracts with third third Unless earlier terminated, the Amended MSA continues in effect until the later of the expiration of the obligation of Grünenthal to make royalty and supply and trademark fee payments or the end of any transition period for manufacturing obligations due to the expiration or termination of the Amended License Agreement. The Amended MSA is subject to earlier termination in connection with certain termination events in the Amended License Agreement, in the event the parties mutually agree, by a party in the event of an uncured material breach by the other party or upon the bankruptcy or insolvency of either party. For the three six June 30, 2019, $0.9 $1.1 three six June 30, 2018, $0.3 $0.6 June 30, 2019, $0.3 $3.0 February 2016 2029. |
Note 6 - Long-term Debt
Note 6 - Long-term Debt | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | 6 . Long-Term Debt Prior Agreement with Hercules The Prior Agreement with Hercules required equal monthly payments of principal and interest through the scheduled maturity date of March 1, 2020. 6.5% $20.5 May 30, 2019, $8.9 $7.4 $1.3 $0.2 Interest expense related to the Amended Loan Agreement with Hercules was $0.2 $0.1 three June 30, 2019, $0.6 $0.2 six June 30, 2019. $0.6 $0.1 three June 30, 2018, $1.2 $0.3 six June 30, 2018. Loan Agreement with Oxford On May 30, 2019, $25.0 May 30, 2019. $8.9 $15.9 The interest rate is calculated at a rate equal to the sum of (a) the greater of (i) the 30 2.50%, 6.75%. July 1, 2020 June 1, 2023. may July 1, 2021, June 30, 2020, $45.0 5% The Company may 2% May 30, 2020, 1.5% May 30, 2020, May 30, 2021 1% 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 $5.0 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 $250,000, $500,000 5% may may May 30, 2019 ( June 30, 2019, $0.7 $0.7 two In connection with the Loan Agreement, on May 30, 2019, 176,679 $2.83, 9 Interest expense related to the Loan Agreement was $0.3 $0.1 three six June 30, 2019. |
Note 7 - Leases
Note 7 - Leases | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 7 . Leases Office Lease The Company leases office and laboratory space for its corporate headquarters, located at 301 351 June 2017, February 1, 2018 January 31, 2024 six not $0.1 3% February 1 st first two not not $0.4 December 2019. On January 2, 2019, 47% February 16, 2019 January 31, 2024, $48,000 3% February 1 st 2019. January 2, 2019, 45 $0.4 $0.2 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 Contract Manufacturing Lease On December 12, 2012, December 31, 2017, two eighteen 2013, $0.2 December 31, 2021. The components of lease expense are presented in the following table (in thousands): Three months ended June 30 , 201 9 Six months ended June 30 , 201 9 Operating lease costs $ 340 $ 680 Sublease income (150 ) (296 ) Net lease costs $ 190 $ 384 Other information related to the operating leases is presented in the following table (in thousands, except years and percentages): Three months ended June 30 , 201 9 Six months ended June 30 , 201 9 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows used for operating leases $ 308 $ 613 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: June 30, 2019 Weighted-average remaining term – operating lease (in years) 4.39 Weighted-average discount rate – operating lease 11.72 % Maturities of lease liabilities as of June 30, 2019 Year: 2019 (remaining six months) $ 670 2020 1,468 2021 1,505 2022 1,345 2023 1,386 Thereafter 116 Total future minimum lease payments 6,490 Less imputed interest (1,492 ) Total $ 4,998 Reported as: Operating lease liabilities $ 759 Operating lease liabilities, net of current portion 4,239 Total lease liability $ 4,998 Future minimum sublease payments as of June 30, 2019 Year: 2019 (remaining six months) $ 288 2020 593 2021 610 2022 629 2023 648 Thereafter 54 Total future minimum sublease payments $ 2,822 The rent receivable balance is reported in the balance sheet as follows (in thousands): Reported as: Prepaid expenses and other current assets $ 69 Other assets 394 Total rent receivable $ 463 |
Note 8 - Liability Related to S
Note 8 - Liability Related to Sale of Future Royalties | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Liability Related To Sale Of Future Royalties Disclosure [Text Block] | 8 . Liability Related to Sale of Future Royalties On September 18, 2015, $65.0 75% 80% first four $35.6 80% $44.5 $195.0 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 prior estimates or the timing of such payments is materially different than its prior estimates, the Company prospectively adjusts the amortization of the liability and the effective interest rate. From inception through December 31, 2018, 13.0%. three June 30, 2019, 4.2%, $65.0 $36 $29 may The current change in estimate reduces the effective interest rate over the life of the liability to 0% $2.7 $0.03 three six June 30, 2019. three June 30, 2019 4.2%. six June 30, 2019 1.4%. 13.4% 13.5% three six June 30, 2018, The following table shows the activity within the liability account for the six June 30, 2019 ( Six months ended Period from Liability related to sale of future royalties — beginning balance $ 93,679 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (161 ) (538 ) Non-cash interest expense recognized 611 33,483 Liability related to sale of future royalties as of June 30, 2019 94,129 94,129 Less: current portion (592 ) (592 ) Liability related to sale of future royalties — net of current portion $ 93,537 $ 93,537 As royalties and milestones are remitted to PDL from the Company’s subsidiary, ARPI LLC, as described in Note 1 |
Note 9 - Warrants
Note 9 - Warrants | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Warrants Disclosure [Text Block] | 9 . Warrants Loan Agreement Warrants In connection with the Loan Agreement, on May 30, 2019, 176,679 $2.83, may ten The Company estimated the fair value of these Warrants as of the issuance date to be $0.4 $2.83, $2.66, ten 2.22%, 80.22% 0% As of June 30, 2019, 176,679 not May 2029. |
Note 10 - Stock-based Compensat
Note 10 - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | 1 0 . Stock-Based Compensation The Company recorded total stock-based compensation expense for stock options, stock awards and the 2011 Three Months Ended Six Months Ended 201 9 201 8 201 9 201 8 Cost of goods sold $ 68 $ 74 $ 129 $ 161 Research and development 233 377 457 809 Selling, general and administrative 1,045 597 1,867 1,158 Total $ 1,346 $ 1,048 $ 2,453 $ 2,128 As of June 30, 2019, 1,895,351 12,773,640 959,642 2011 773,754 |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 1 1 . Stockholders’ Equity Common Stock ATM Agreement On May 9, 2019, may SM $40.0 no three six June 30, 2019. June 30, 2019, may $46,564,331, |
Note 12 - Net Loss Per Share of
Note 12 - Net Loss Per Share of Common Stock | 6 Months Ended |
Jun. 30, 2019 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 1 2 . 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, options to purchase common stock and warrants to purchase common stock were considered to be common stock equivalents. In periods with a reported net loss, common stock equivalents are excluded from the calculation of diluted net loss per share of common stock if their effect is antidilutive. The 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: June 30 , 201 9 201 8 RSUs, ESPP and stock options to purchase common stock 14,090,688 11,779,042 Common stock warrants 176,679 176,730 |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Business Description of Entity [Policy Text Block] | 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 ® ® November 2, 2018, June 2018, first 2019. not may one not 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 will only be 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 will need to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA will not Zalviso Zalviso delivers 15 September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 On December 16, 2013, July 17, 2015 September 20, 2016, September 2015, December 16, 2013, July 22, 2015, July 17, 2015. The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although Zalviso has been approved for sale in Europe, on September 18, 2015, November 2018 first 2019. 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. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, ARPI LLC, which was formed in September 2015 8 |
Reclassification, Policy [Policy Text Block] | Reclassifications Certain prior year amounts in the condensed consolidated financial statements have been reclassified to conform to the current year's presentation. |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and the rules and regulations of the United States. Securities and Exchange Commission, or SEC. Accordingly, they do not Operating results for the three six June 30, 2019, not may December 31, 2019. December 31, 2018, December 31, 2018, 10 10 December 31, 2018, |
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 condensed 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 |
Inventory, Policy [Policy Text Block] | Inventories Inventories are valued at the lower of cost and net realizable value. Cost is determined using the first first third 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 market approach as that used to value the inventory. Because the predetermined, contractual transfer prices the Company is receiving from Grünenthal are less than the direct costs of manufacturing, all Zalviso inventories are carried at net realizable value. |
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 balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, the Company no |
Revenue from Contract with Customer [Policy Text Block] | Revenue from Contracts with Customers Beginning January 1, 2018, 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. Net product sales revenue 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, such as hospitals, surgical centers, and emergency departments. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and/or privately-negotiated discounts with respect to the purchase of its products. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of discounts, returns and GPO discounts and administrative fees. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. Variable consideration is estimated using the most-likely amount method, which is the single-most likely outcome under a contract and is typically at the stated contractual rate. Actual amounts of consideration ultimately received may ● Distributor Fees – The Company offers contractually determined discounts to its Customers. These discounts are paid no two ● GPO Discounts - The Company offers discounts to GPO members. These discounts are taken when the GPO members purchase DSUVIA from the Company’s customers, who then charge the discount amount back to the Company. ● GPO Administrative Fees - The Company pays administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPOs’ members. ● Returns – The Company allows its Customers to return product for credit 12 may The Company believes its estimated allowance for product returns requires a high degree of judgment and is subject to change based on its experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distributor fees, GPO discounts and administrative fees do not Amounts accrued for product revenue allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate and to reflect actual experience. Product revenue-related liabilities are recorded in the Company’s condensed consolidated balance sheets as Accrued liabilities. The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust these estimates accordingly. Changes in sales allowance estimates could materially affect the Company’s results of operations and financial position. Collaboration agreement r evenue 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. Contract and other 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. The DoD Contract period of performance ended on February 28, 2019. 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 condensed 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 Revenues from product sales are recognized when distributors obtain control of the Company’s products, which occurs at a point in time, upon delivery to such distributors. 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 Amended Agreements with Grünenthal, the Company sells Zalviso to Grünenthal at predetermined, contractual transfer prices that are less than the direct costs of manufacturing and recognizes indirect costs as period costs where they are in excess of normal capacity and not third |
Interest Expense, Policy [Policy Text Block] | Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties In September 2015, December 16, 2013, $65.0 $195.0 $61.2 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), 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 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Standards On August 29, 2018, No. 2018 15, Intangibles – Goodwill and Other – Internal Use Software (Subtopic 350 40 ” The amendments in ASU No. 2018 15 ASU No. 2018 15 December 15, 2019, not 1 first 2 No. 2018 15 January 1, 2019 not In August 2018, No. 33 10532, Disclosure Update and Simplification , In February 2016, No. 2016 02, Leases (Topic 842 January, July December 2018, July 2018 No. 2018 11, Leases (Topic 842 12 No. 2016 02 January 1, 2019. 1 not 2 not 3 not The adoption of the new leases standard resulted in the following adjustments to the consolidated balance sheet as of January 1, 2019 ( Increase/(Decrease) Operating lease right-of-use assets $ 4,730 Accrued liabilities (a) $ (100 ) Operating lease liabilities $ 484 Operating lease liabilities, net of current portion $ 4,610 Deferred rent, net of current portion $ (416 ) Accumulated deficit (b) $ (153 ) (a) Represents current portion of Deferred rent reclassified to Operating lease liabilities. (b) Represents cumulative-effect adjustment upon adoption of ASU No. 2016 02. The adoption of ASU No. 2016 02, not Recently Issued Accounting Standards In June 2016, 2016 13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments , 2016 13. 2016 13 2016 13 December 15, 2019. May 2019, 2019 05, Financial Instruments – Credit Losses” 2019 05, 2016 13. 2016 13 2019 05 not |
Note 1 - Organization and Sum_2
Note 1 - Organization and Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles [Table Text Block] | Increase/(Decrease) Operating lease right-of-use assets $ 4,730 Accrued liabilities (a) $ (100 ) Operating lease liabilities $ 484 Operating lease liabilities, net of current portion $ 4,610 Deferred rent, net of current portion $ (416 ) Accumulated deficit (b) $ (153 ) |
Note 2 - Investments and Fair_2
Note 2 - Investments and Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Cash, Cash Equivalents and Investments [Table Text Block] | As of June 30 , 201 9 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash and cash equivalents: Cash $ 3,018 $ — $ — $ 3,018 Money market funds 286 — — 286 Commercial paper 61,767 — — 61,767 Total cash and cash equivalents 65,071 — — 65,071 Short-term investments: Commercial paper $ 26,475 $ — $ — $ 26,475 Total cash, cash equivalents and investments $ 91,546 $ — $ — $ 91,546 As of December 31 , 201 8 Amortized Cost Gross Unrealized Gross Unrealized Fair Cash and cash equivalents: Cash $ 2,037 $ — $ — $ 2,037 Money market funds 1,436 — — 1,436 U.S. government agency securities 10,181 — — 10,181 Commercial paper 74,321 — — 74,321 Total cash and cash equivalents 87,975 — — 87,975 Short-term investments: U.S. government agency securities $ 1,497 $ — $ — $ 1,497 Commercial paper 16,243 — — 16,243 Total marketable securities and commercial paper 17,740 — — 17,740 Total cash, cash equivalents and investments $ 105,715 $ — $ — $ 105,715 |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | As of June 30 , 2019 Fair Value Level I Level II Level III Assets Money market funds $ 286 $ 286 $ — $ — Commercial paper 88,242 — 88,242 — Total assets measured at fair value $ 88,528 $ 286 $ 88,242 $ — Liabilities Contingent put option liability $ 657 $ — $ — $ 657 Total liabilities measured at fair value $ 657 $ — $ — $ 657 As of December 31 , 201 8 Fair Value Level I Level II Level III Assets Money market funds $ 1,436 $ 1,436 $ — $ — U.S. government agency securities 11,678 — 11,678 — Commercial paper 90,564 — 90,564 — Total assets measured at fair value $ 103,678 $ 1,436 $ 102,242 $ — Liabilities Contingent put option liability $ 121 $ — $ — $ 121 Total liabilities measured at fair value $ 121 $ — $ — $ 121 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three Months 9 Six Months 9 Fair value—beginning of period $ 98 $ 121 Fair value of contingent put option associated with the Loan Agreement 657 657 Change in fair value of contingent put option associated with the Prior Agreement (98 ) (121 ) Fair value—end of period $ 657 $ 657 Three Months 8 Six Months 8 Fair value—beginning of period $ 186 $ 207 Change in fair value of contingent put option associated with the Prior Agreement (20 ) (41 ) Fair value—end of period $ 166 $ 166 |
Note 3 - Inventories (Tables)
Note 3 - Inventories (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | Balance as of June 30 , 2019 December 31, 201 8 Raw materials $ 1,422 $ 694 Work-in-process 273 160 Finished goods 1,149 — Total $ 2,844 $ 854 |
Note 4 - Revenue (Tables)
Note 4 - Revenue (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Contract with Customer, Asset and Liability [Table Text Block] | Balance at Beginning of the Period Additions Deductions Balance at the end of the Period (in thousands) Contract liability: Deferred revenue $ 3,463 $ 131 $ (280 ) $ 3,314 |
Disaggregation of Revenue [Table Text Block] | Three months ended June 30, 201 9 Six months ended June 30, 201 9 Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied – Amended Agreements $ 79 $ 158 New activities in the period from performance obligations satisfied: Performance obligations satisfied – Amended Agreements 649 677 Total revenue from performance obligations satisfied 728 835 Royalty revenue 158 269 Net product sales 55 102 Total revenue $ 941 $ 1,206 |
Note 7 - Leases (Tables)
Note 7 - Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three months ended June 30 , 201 9 Six months ended June 30 , 201 9 Operating lease costs $ 340 $ 680 Sublease income (150 ) (296 ) Net lease costs $ 190 $ 384 Three months ended June 30 , 201 9 Six months ended June 30 , 201 9 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows used for operating leases $ 308 $ 613 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 June 30, 2019 Weighted-average remaining term – operating lease (in years) 4.39 Weighted-average discount rate – operating lease 11.72 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Year: 2019 (remaining six months) $ 670 2020 1,468 2021 1,505 2022 1,345 2023 1,386 Thereafter 116 Total future minimum lease payments 6,490 Less imputed interest (1,492 ) Total $ 4,998 Operating lease liabilities $ 759 Operating lease liabilities, net of current portion 4,239 Total lease liability $ 4,998 |
Lessee, Operating Sublease, to Be Received, Maturity [Table Text Block] | Year: 2019 (remaining six months) $ 288 2020 593 2021 610 2022 629 2023 648 Thereafter 54 Total future minimum sublease payments $ 2,822 Prepaid expenses and other current assets $ 69 Other assets 394 Total rent receivable $ 463 |
Note 8 - Liability Related to_2
Note 8 - Liability Related to Sale of Future Royalties (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Other Liabilities [Table Text Block] | Six months ended Period from Liability related to sale of future royalties — beginning balance $ 93,679 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (161 ) (538 ) Non-cash interest expense recognized 611 33,483 Liability related to sale of future royalties as of June 30, 2019 94,129 94,129 Less: current portion (592 ) (592 ) Liability related to sale of future royalties — net of current portion $ 93,537 $ 93,537 |
Note 10 - Stock-based Compens_2
Note 10 - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended Six Months Ended 201 9 201 8 201 9 201 8 Cost of goods sold $ 68 $ 74 $ 129 $ 161 Research and development 233 377 457 809 Selling, general and administrative 1,045 597 1,867 1,158 Total $ 1,346 $ 1,048 $ 2,453 $ 2,128 |
Note 12 - Net Loss Per Share _2
Note 12 - Net Loss Per Share of Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | June 30 , 201 9 201 8 RSUs, ESPP and stock options to purchase common stock 14,090,688 11,779,042 Common stock warrants 176,679 176,730 |
Note 1 - Organization and Sum_3
Note 1 - Organization and Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | Sep. 18, 2015 | Sep. 30, 2015 | Jun. 30, 2019 | Jun. 30, 2019 |
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | ||
Royalty Arrangment Maximum Payments | $ 195,000 | 195,000 | ||
Net Proceeds from Sale of Future Royalties | $ 61,200 | $ 61,184 |
Note 1 - Organization and Sum_4
Note 1 - Organization and Summary of Significant Accounting Policies - Adjustments for Adoption of New Lease Standard (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | ||
Operating lease right-of-use assets | $ 4,326 | [1] | |||
Accrued liabilities | 4,276 | 4,540 | [1] | ||
Operating lease liabilities, current portion | 759 | [1] | |||
Operating lease liabilities, net of current portion | 4,239 | [1] | |||
Accumulated deficit | $ (370,952) | $ (345,019) | |||
Accounting Standards Update 2016-02 [Member] | |||||
Operating lease right-of-use assets | $ 4,730 | ||||
Accrued liabilities | [2] | (100) | |||
Operating lease liabilities, current portion | 484 | ||||
Operating lease liabilities, net of current portion | 4,610 | ||||
Deferred rent, net of current portion | (416) | ||||
Accumulated deficit | [3] | $ (153) | |||
[1] | The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. | ||||
[2] | Represents current portion of Deferred rent reclassified to Operating lease liabilities. | ||||
[3] | Represents cumulative-effect adjustment upon adoption of ASU No. 2016-02. |
Note 2 - Investments and Fair_3
Note 2 - Investments and Fair Value Measurement (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Dec. 31, 2018 | |
Available-for-sale Securities, Gross, Unrealized Gain (Loss) Accumulated In Investments | $ 0 | $ 0 | $ 0 | |
Other than Temporary Impairment Losses, Investments, Available-for-sale Securities, Total | 0 | 0 | ||
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | 0 | 0 | ||
Other Comprehensive Income (Loss), Transfers from Held-to-maturity to Available-for-Sale Securities, Net of Tax | $ 0 | $ 0 | $ 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 | Jun. 30, 2019 | Dec. 31, 2018 |
Amortized Cost | $ 91,546 | $ 105,715 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 91,546 | 105,715 |
Cash and Cash Equivalents [Member] | ||
Amortized Cost | 65,071 | 87,975 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 65,071 | 87,975 |
Cash and Cash Equivalents [Member] | Cash [Member] | ||
Amortized Cost | 3,018 | 2,037 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 3,018 | 2,037 |
Cash and Cash Equivalents [Member] | Money Market Funds [Member] | ||
Amortized Cost | 286 | 1,436 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 286 | 1,436 |
Cash and Cash Equivalents [Member] | Commercial Paper [Member] | ||
Amortized Cost | 61,767 | 74,321 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 61,767 | 74,321 |
Cash and Cash Equivalents [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 10,181 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 10,181 | |
Marketable Securities [Member] | ||
Amortized Cost | 17,740 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 17,740 | |
Marketable Securities [Member] | Commercial Paper [Member] | ||
Amortized Cost | 26,475 | 16,243 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | $ 26,475 | 16,243 |
Marketable Securities [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 1,497 | |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | $ 1,497 |
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 | Jun. 30, 2019 | Dec. 31, 2018 |
Assets, fair value | $ 88,528 | $ 103,678 |
Liabilities, fair value | 657 | 121 |
Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 657 | 121 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 286 | 1,436 |
Liabilities, fair value | ||
Fair Value, Inputs, Level 1 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 88,242 | 102,242 |
Liabilities, fair value | ||
Fair Value, Inputs, Level 2 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | ||
Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | ||
Liabilities, fair value | 657 | 121 |
Fair Value, Inputs, Level 3 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 657 | 121 |
Money Market Funds [Member] | ||
Assets, fair value | 286 | 1,436 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 286 | 1,436 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | ||
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | ||
Commercial Paper [Member] | ||
Assets, fair value | 88,242 | 90,564 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | ||
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 88,242 | 90,564 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | ||
U.S. Government Agency Obligations [Member] | ||
Assets, fair value | 11,678 | |
U.S. Government Agency Obligations [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | ||
U.S. Government Agency Obligations [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 11,678 | |
U.S. Government Agency Obligations [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value |
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 | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Fair value, Beginning of period | $ 98 | $ 186 | $ 121 | $ 207 |
Fair value of contingent put option associated with the Loan Agreement | 657 | 657 | ||
Change in fair value of contingent put option associated with the Prior Agreement | (98) | (20) | (121) | (41) |
Fair value, End of period | $ 657 | $ 166 | $ 657 | $ 166 |
Note 3 - Inventories - Inventor
Note 3 - Inventories - Inventory Components (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | |
Raw materials | $ 1,422 | $ 694 | |
Work-in-process | 273 | 160 | |
Finished goods | 1,149 | ||
Total | $ 2,844 | $ 854 | [1] |
[1] | The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. |
Note 4 - Revenue (Details Textu
Note 4 - Revenue (Details Textual) $ in Millions | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Discount on Manufacturing Services | $ 3.3 |
Note 4 - Revenue - Changes in C
Note 4 - Revenue - Changes in Contract Liabilities (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Contract Liabilities: Deferred Revenue | $ 3,463 |
Contract Liabilities: Deferred Revenue, Additions | 131 |
Contract Liabilities: Deferred Revenue, Deductions | (280) |
Contract Liabilities: Deferred Revenue | $ 3,314 |
Note 4 - Revenue - Disaggregati
Note 4 - Revenue - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied – Amended Agreements | $ 79 | $ 158 | ||
New activities in the period from performance obligations satisfied: Performance obligations satisfied – Amended Agreements | 649 | 677 | ||
Revenue | 941 | $ 818 | 1,206 | $ 1,161 |
Amended License Agreement [Member] | ||||
Revenue | 728 | 835 | ||
Royalty Revenue [Member] | ||||
Revenue | 158 | 269 | ||
Product [Member] | ||||
Revenue | $ 55 | $ 102 |
Note 5 - Collaboration Agreem_2
Note 5 - Collaboration Agreement (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | [1] | |
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | $ 194,500 | $ 194,500 | ||||
Revenue from Contract with Customer, Including Assessed Tax | 941 | $ 818 | 1,206 | $ 1,161 | ||
Contract with Customer, Liability, Current | 324 | 324 | $ 315 | |||
Contract with Customer, Liability, Noncurrent | 2,990 | 2,990 | $ 3,148 | |||
Collaboration Agreement Revenue [Member] | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 886 | $ 351 | 1,104 | $ 625 | ||
Contract with Customer, Liability, Current | 300 | 300 | ||||
Contract with Customer, Liability, Noncurrent | 3,000 | 3,000 | ||||
Based upon Successful Regulatory and Product Development Efforts [Member] | ||||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | 28,500 | 28,500 | ||||
Based upon Net Sales Target Achievements [Member] | ||||||
Revenue Recognition Milestone Method Agreed, Additional Amount, Based On Efforts And Targets | $ 166,000 | $ 166,000 | ||||
[1] | The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. |
Note 6 - Long-term Debt (Detail
Note 6 - Long-term Debt (Details Textual) - USD ($) | May 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Mar. 02, 2017 |
Repayments of Long-term Debt, Total | $ 3,470,000 | $ 3,762,000 | ||||
Interest Expense, Total | $ 500,000 | $ 586,000 | 876,000 | 1,229,000 | ||
Amortization of Debt Discount (Premium) | 234,000 | 344,000 | ||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 176,679 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.83 | |||||
Loan Agreement with Oxford Finance LLC [Member] | ||||||
Debt Instrument, Final Payment, Percentage of Aggregate Principal Amount | 5.00% | |||||
Debt Instrument, Face Amount | $ 25,000,000 | |||||
Repayments of Long-term Debt, Total | 8,900,000 | |||||
Interest Expense, Total | 300,000 | |||||
Amortization of Debt Discount (Premium) | 100,000 | |||||
Proceeds from Debt, Net of Issuance Costs and Repayment of Debt | $ 15,900,000 | |||||
Debt Instrument, Interest Rate, Base Percentage | 2.50% | |||||
Prepayment Charge, Percentage of Outstanding Balance, Before May 30,2020 | 2.00% | |||||
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 | $ 700,000 | 700,000 | 700,000 | |||
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] | ||||||
Debt Instrument, Final Payment, Percentage of Aggregate Principal Amount | 6.50% | |||||
Debt Instrument, Face Amount | $ 20,500,000 | |||||
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 | 200,000 | 600,000 | 600,000 | 1,200,000 | ||
Amortization of Debt Discount (Premium) | $ 100,000 | $ 100,000 | $ 200,000 | $ 300,000 |
Note 7 - Leases (Details Textua
Note 7 - Leases (Details Textual) - USD ($) | Jan. 02, 2019 | Dec. 12, 2012 | Jun. 30, 2017 | Jun. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Feb. 16, 2019 |
Lessee, Operating Lease, Renewal Term | 2 years | 6 years | |||||
Lessee, Operating Lease, Monthly Rent | $ 100,000 | ||||||
Lessee, Operating Lease, Annual Rent Increase | 3.00% | ||||||
Lessee, Operating Lease, Initial Tenant Incentive Allowance | $ 400,000 | ||||||
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 | $ 242,000 | |||||
Increase (Decrease) in Operating Lease Liabilities | (24,000) | $ (313,000) | |||||
Lessee, Operating Lease, Notice Period | 1 year 180 days | ||||||
Lessee, Operating Lease, Annual Overhead Fee Payments | $ 200,000 | ||||||
Increase (Decrease) in Right-of-use Assets | $ (24,000) |
Note 7 - Leases - Operating Lea
Note 7 - Leases - Operating Lease Costs (Details) - USD ($) | Jan. 02, 2019 | Jun. 30, 2019 | Jun. 30, 2019 |
Operating lease costs | $ 340,000 | $ 680,000 | |
Sublease income | (150,000) | (296,000) | |
Net lease costs | 190,000 | 384,000 | |
Operating cash flows used for operating leases | 308,000 | 613,000 | |
Transfer of tenant improvement allowance to sublease | $ 200,000 | 242,000 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 4,730,000 | ||
Weighted-average remaining term – operating lease (Year) | 4 years 142 days | 4 years 142 days | |
Weighted-average discount rate – operating lease | 11.72% | 11.72% |
Note 7 - Leases - Maturities of
Note 7 - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | [1] |
2019 (remaining six months) | $ 670 | ||
2020 | 1,468 | ||
2021 | 1,505 | ||
2022 | 1,345 | ||
2023 | 1,386 | ||
Thereafter | 116 | ||
Total future minimum lease payments | 6,490 | ||
Less imputed interest | (1,492) | ||
Total | 4,998 | ||
Operating lease liabilities, current portion | 759 | ||
Operating lease liabilities, net of current portion | 4,239 | ||
Total lease liability | $ 4,998 | ||
[1] | The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. |
Note 7 - Leases - Future Minimu
Note 7 - Leases - Future Minimum Sublease Payments (Details) $ in Thousands | Jun. 30, 2019USD ($) |
2019 (remaining six months) | $ 288 |
2020 | 593 |
2021 | 610 |
2022 | 629 |
2023 | 648 |
Thereafter | 54 |
Total future minimum sublease payments | 2,822 |
Rent receivable | 463 |
Prepaid Expenses and Other Current Assets [Member] | |
Rent receivable | 69 |
Other Assets [Member] | |
Rent receivable | $ 394 |
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, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 |
Proceeds From Sale of Royalty and Milestone Rights | $ 65 | $ 65 | |||||
Royalty Arrangment Maximum Payments | $ 195 | $ 195 | |||||
Effective Annual Interest Rate | 4.20% | 13.40% | 1.40% | 13.50% | 13.00% | ||
Prospective Average Rate for Remaining Term of the Agreement | 4.20% | ||||||
Estimate Future Payments Receivable Over Remaining Life of Arrangment | $ 36 | ||||||
Contingent Gain (Loss) on Royalty Monetization Arrangement | $ 29 | ||||||
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 | $ (2.7) | $ (2.7) | |||||
Net Income (Loss) Per Share, Change Estimate on Liability Related to Sale of Future Royalties | $ (0.03) | $ (0.03) | |||||
PDL [Member] | |||||||
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 | 3 Months Ended | 6 Months Ended | 45 Months Ended | ||||
Sep. 30, 2015 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Dec. 31, 2018 | [1] | |
Liability related to sale of future royalties — beginning balance | $ 93,679 | |||||||
Proceeds from sale of future royalties | $ 61,200 | 61,184 | ||||||
Non-cash royalty revenue | (161) | (538) | ||||||
Non-cash interest expense recognized | $ (996) | $ 2,995 | 611 | $ 5,811 | 33,483 | |||
Liability related to sale of future royalties as of June 30, 2019 | 94,129 | 94,129 | 94,129 | |||||
Less: current portion | (592) | (592) | (592) | $ (392) | ||||
Liability related to sale of future royalties — net of current portion | $ 93,537 | $ 93,537 | $ 93,537 | $ 93,287 | ||||
[1] | The condensed consolidated balance sheet as of December 31, 2018 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. |
Note 9 - Warrants (Details Text
Note 9 - Warrants (Details Textual) - Warrant In Connection with Oxford Finance Loan Agreement [Member] $ / shares in Units, $ in Millions | Jun. 30, 2019shares | May 30, 2019USD ($)$ / sharesyrshares |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 176,679 | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 2.83 | |
Warrants and Rights Outstanding, Term | 10 years | |
Warrants and Rights Outstanding | $ | $ 0.4 | |
Class of Warrant or Right, Outstanding | shares | 176,679 | |
Measurement Input, Exercise Price [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 2.83 | |
Measurement Input, Share Price [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 2.66 | |
Measurement Input, Expected Term [Member] | ||
Warrants and Rights Outstanding, Measurement Input | yr | 10 | |
Measurement Input, Risk Free Interest Rate [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 0.0222 | |
Measurement Input, Price Volatility [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 0.8022 | |
Measurement Input, Expected Dividend Rate [Member] | ||
Warrants and Rights Outstanding, Measurement Input | 0 |
Note 10 - Stock-based Compens_3
Note 10 - Stock-based Compensation (Details Textual) | Jun. 30, 2019shares |
2011 Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,895,351 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 12,773,640 |
2011 Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number, Ending Balance | 959,642 |
Employee Stock Purchase Plan (ESPP) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 773,754 |
Note 10 - Stock-based Compens_4
Note 10 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Stock-based compensation expense | $ 1,346 | $ 1,048 | $ 2,453 | $ 2,128 |
Cost of Sales [Member] | ||||
Stock-based compensation expense | 68 | 74 | 129 | 161 |
Research and Development Expense [Member] | ||||
Stock-based compensation expense | 233 | 377 | 457 | 809 |
Selling, General and Administrative Expenses [Member] | ||||
Stock-based compensation expense | $ 1,045 | $ 597 | $ 1,867 | $ 1,158 |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity (Details Textual) - USD ($) | May 09, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 |
Stock Issued During Period, Value, New Issues | $ 7,407,000 | |||
ATM Agreement [Member] | ||||
Aggregate Offering Price, Increase During Period | $ 40,000,000 | |||
Stock Issued During Period, Value, New Issues | $ 0 | $ 0 | ||
Public Offering [Member] | ||||
Aggregate Offering Price, Maximum | $ 46,564,331 |
Note 12 - Net Loss Per Share _3
Note 12 - Net Loss Per Share of Common Stock - Common Stock Excluded from Computation of Diluted Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
RSU's, ESPP, and Employee Stock Options [Member] | ||
Antidilutive securities (in shares) | 14,090,688 | 11,779,042 |
Warrant [Member] | ||
Antidilutive securities (in shares) | 176,679 | 176,730 |