Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 11, 2021 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0001427925 | |
Entity Registrant Name | ACELRX PHARMACEUTICALS INC | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-35068 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 41-2193603 | |
Entity Address, Address Line One | 25821 Industrial Boulevard, Suite 400 | |
Entity Address, City or Town | Hayward | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94545 | |
City Area Code | 650 | |
Local Phone Number | 216-3500 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | ACRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 119,179,806 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Current Assets: | |||
Cash and cash equivalents | $ 26,327 | $ 27,274 | [1] |
Short-term investments | 28,998 | 15,612 | [1] |
Accounts receivable, net | 104 | 635 | [1] |
Inventories, net | 1,363 | 1,626 | [1] |
Prepaid expenses and other current assets | 2,178 | 1,683 | [1] |
Total current assets | 58,970 | 46,830 | [1] |
Operating lease right-of-use assets | 4,607 | 3,150 | [1] |
Property and equipment, net | 15,939 | 15,659 | [1] |
Other assets | 70 | 656 | [1] |
Total Assets | 79,586 | 66,295 | [1] |
Current Liabilities: | |||
Accounts payable | 1,941 | 2,737 | [1] |
Accrued and other liabilities | 3,980 | 5,045 | [1] |
Long-term debt, current portion | 8,764 | 8,735 | [1] |
Operating lease liabilities, current portion | 503 | 1,118 | [1] |
Total current liabilities | 15,188 | 17,635 | [1] |
Long-term debt, net of current portion | 9,374 | 13,140 | [1] |
Operating lease liabilities, net of current portion | 4,115 | 2,606 | [1] |
Liability related to the sale of future royalties, net of current portion | 86,770 | 88,365 | [1] |
Other long-term liabilities | 128 | 299 | [1] |
Total liabilities | 115,575 | 122,045 | [1] |
Commitments and Contingencies | |||
Stockholders’ Deficit: | |||
Common stock, $0.001 par value—200,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 119,179,806 and 98,812,008 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 119 | 98 | [1] |
Additional paid-in capital | 421,184 | 382,637 | [1] |
Accumulated deficit | (457,292) | (438,485) | [1] |
Total stockholders’ deficit | (35,989) | (55,750) | [1] |
Total Liabilities and Stockholders’ Deficit | $ 79,586 | $ 66,295 | [1] |
[1] | The condensed consolidated balance sheet as of December 31, 2020 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, 2020. |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 119,179,806 | 98,812,008 |
Common stock, shares outstanding (in shares) | 119,179,806 | 98,812,008 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue: | ||||
Revenue | $ 443 | $ 2,924 | $ 954 | $ 3,310 |
Operating costs and expenses: | ||||
Cost of goods sold | 1,040 | 1,370 | 2,080 | 2,881 |
Research and development | 724 | 813 | 1,693 | 2,225 |
Selling, general and administrative | 8,694 | 7,575 | 16,338 | 20,886 |
Total operating costs and expenses | 10,458 | 9,758 | 20,111 | 25,992 |
Loss from operations | (10,015) | (6,834) | (19,157) | (22,682) |
Other income: | ||||
Interest expense | (614) | (872) | (1,286) | (1,727) |
Interest income and other (expense) income, net | (16) | 270 | 60 | 205 |
Non-cash interest income on liability related to future sale of royalties | 799 | 834 | 1,581 | 1,677 |
Total other income | 169 | 232 | 355 | 155 |
Net loss before income taxes | (9,846) | (6,602) | (18,802) | (22,527) |
Provision for income taxes | (5) | (4) | (5) | (4) |
Net loss | (9,851) | (6,606) | (18,807) | (22,531) |
Comprehensive loss | $ (9,851) | $ (6,606) | $ (18,807) | $ (22,531) |
Net loss per share of common stock, basic and diluted (in dollars per share) | $ (0.08) | $ (0.08) | $ (0.16) | $ (0.28) |
Shares used in computing net loss per share of common stock, basic and diluted – See Note 11 (in shares) | 119,120,040 | 80,661,853 | 116,204,492 | 80,359,679 |
Product [Member] | ||||
Revenue: | ||||
Revenue | $ 392 | $ 303 | $ 843 | $ 577 |
Contract and Other Collaboration [Member] | ||||
Revenue: | ||||
Revenue | $ 51 | $ 2,621 | $ 111 | $ 2,733 |
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] | Total | |
Balance (in shares) at Dec. 31, 2019 | 79,573,101 | ||||
Balance at Dec. 31, 2019 | $ 79 | $ 356,609 | $ (398,106) | $ (41,418) | |
Stock-based compensation | 1,146 | 1,146 | |||
Restricted stock units vested (in shares) | 216,399 | ||||
Tax payments related to shares withheld for restricted stock units vested | (86) | (86) | |||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 431,800 | ||||
Net proceeds from issuance of common stock in connection with equity financings | $ 1 | 783 | 784 | ||
Issuance of common stock upon ESPP purchase (in shares) | 194,451 | ||||
Issuance of common stock upon ESPP purchase | 218 | 218 | |||
Net loss | (15,925) | (15,925) | |||
Balance (in shares) at Mar. 31, 2020 | 80,415,751 | ||||
Balance at Mar. 31, 2020 | $ 80 | 358,670 | (414,031) | (55,281) | |
Balance (in shares) at Dec. 31, 2019 | 79,573,101 | ||||
Balance at Dec. 31, 2019 | $ 79 | 356,609 | (398,106) | (41,418) | |
Net loss | (22,531) | ||||
Balance (in shares) at Jun. 30, 2020 | 80,890,185 | ||||
Balance at Jun. 30, 2020 | $ 80 | 360,425 | (420,637) | (60,132) | |
Balance (in shares) at Mar. 31, 2020 | 80,415,751 | ||||
Balance at Mar. 31, 2020 | $ 80 | 358,670 | (414,031) | (55,281) | |
Stock-based compensation | 1,090 | 1,090 | |||
Restricted stock units vested (in shares) | 29,434 | ||||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 445,000 | ||||
Net proceeds from issuance of common stock in connection with equity financings | 665 | 665 | |||
Net loss | (6,606) | (6,606) | |||
Balance (in shares) at Jun. 30, 2020 | 80,890,185 | ||||
Balance at Jun. 30, 2020 | $ 80 | 360,425 | (420,637) | (60,132) | |
Balance (in shares) at Dec. 31, 2020 | 98,812,008 | ||||
Balance at Dec. 31, 2020 | $ 98 | 382,637 | (438,485) | (55,750) | [1] |
Stock-based compensation | 1,089 | 1,089 | |||
Restricted stock units vested (in shares) | 404,172 | ||||
Tax payments related to shares withheld for restricted stock units vested | (249) | (249) | |||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 19,701,562 | ||||
Net proceeds from issuance of common stock in connection with equity financings | $ 20 | 36,340 | 36,360 | ||
Issuance of common stock upon ESPP purchase (in shares) | 183,132 | ||||
Issuance of common stock upon ESPP purchase | 192 | 192 | |||
Issuance of common stock upon exercise of stock options (in shares) | 2,125 | ||||
Issuance of common stock upon exercise of stock options | 2 | 2 | |||
Net loss | (8,956) | (8,956) | |||
Balance (in shares) at Mar. 31, 2021 | 119,102,999 | ||||
Balance at Mar. 31, 2021 | $ 118 | 420,011 | (447,441) | (27,312) | |
Balance (in shares) at Dec. 31, 2020 | 98,812,008 | ||||
Balance at Dec. 31, 2020 | $ 98 | 382,637 | (438,485) | (55,750) | [1] |
Net loss | (18,807) | ||||
Balance (in shares) at Jun. 30, 2021 | 119,179,806 | ||||
Balance at Jun. 30, 2021 | $ 119 | 421,184 | (457,292) | (35,989) | |
Balance (in shares) at Mar. 31, 2021 | 119,102,999 | ||||
Balance at Mar. 31, 2021 | $ 118 | 420,011 | (447,441) | (27,312) | |
Stock-based compensation | 1,172 | 1,172 | |||
Restricted stock units vested (in shares) | 74,438 | ||||
Issuance of common stock upon exercise of stock options (in shares) | 2,369 | ||||
Issuance of common stock upon exercise of stock options | $ 1 | 1 | 2 | ||
Net loss | (9,851) | (9,851) | |||
Balance (in shares) at Jun. 30, 2021 | 119,179,806 | ||||
Balance at Jun. 30, 2021 | $ 119 | $ 421,184 | $ (457,292) | $ (35,989) | |
[1] | The condensed consolidated balance sheet as of December 31, 2020 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, 2020. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 69 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | |
Cash flows from operating activities: | |||||||
Net loss | $ (9,851) | $ (8,956) | $ (6,606) | $ (15,925) | $ (18,807) | $ (22,531) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Non-cash royalty revenue related to royalty monetization | (83) | (121) | |||||
Non-cash interest income on liability related to royalty monetization | (799) | (834) | (1,581) | (1,677) | $ 26,644 | ||
Depreciation and amortization | 1,029 | 979 | |||||
Non-cash interest expense related to debt financing | 430 | 558 | |||||
Stock-based compensation | 2,261 | 2,236 | |||||
Other | (61) | 341 | |||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | 531 | 237 | |||||
Inventories | 143 | 277 | |||||
Prepaid expenses and other assets | (277) | 94 | |||||
Accounts payable | (65) | 675 | |||||
Accrued liabilities | (963) | (1,779) | |||||
Operating lease liabilities | (563) | (442) | |||||
Deferred revenue | (49) | (2,901) | |||||
Net cash used in operating activities | (18,055) | (24,054) | |||||
Cash flows from investing activities: | |||||||
Purchase of property and equipment | (1,615) | (170) | |||||
Purchase of investments | (38,201) | (28,807) | |||||
Proceeds from maturities of investments | 24,784 | 58,555 | |||||
Net cash (used in) provided by investing activities | (15,032) | 29,578 | |||||
Cash flows from financing activities: | |||||||
Payment of long-term debt | (4,167) | 0 | |||||
Net proceeds from issuance of common stock in connection with equity financings | 36,360 | 1,449 | |||||
Net proceeds from issuance of common stock through equity plans | 196 | 218 | |||||
Payment of employee tax obligations related to vesting of restricted stock units | (249) | (86) | |||||
Net cash provided by financing activities | 32,140 | 1,581 | |||||
Net (decrease) increase in cash and cash equivalents | (947) | 7,105 | |||||
Cash and cash equivalents—Beginning of period | $ 27,274 | $ 14,684 | 27,274 | 14,684 | |||
Cash and cash equivalents—End of period | $ 26,327 | $ 21,789 | $ 26,327 | $ 21,789 | $ 26,327 |
Note 1 - Organization and Summa
Note 1 - Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 1. The Company AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on July 13, 2005 January 2006, AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA® November 2, 2018, first 2019. June 2018, not may one July 2021, 12 May 12, 2021 ( Termination of Gr nenthal Agreements July 2021, 10 3 10 50 12 The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. As of June 30, 2021 December 31, 2020, one 10 September 18, 2015, August 31, 2020, third DSUVIA/DZUVEO DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018 June 2018, DSUVIA was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which restricts distribution to certified medically supervised healthcare settings in order to prevent respiratory depression resulting from accidental exposure. DSUVIA is only distributed to facilities certified in the DSUVIA REMS program following attestation by an authorized representative to comply with appropriate dispensing and use restrictions of DSUVIA. To become certified, a healthcare setting is required to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA is not Zalviso Zalviso delivers 15 September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 Termination of Grünenthal Agreements On December 16, 2013, July 17, 2015 September 20, 2016, 28 September 2015, December 16, 2013, July 22, 2015, July 17, 2015. On May 18, 2020, November 13, 2020. May 12, 2021 May 12, 2021. Principles of Consolidation The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note 7 Reclassifications Certain prior period amounts in the Condensed Consolidated Financial Statements have been reclassified to conform to the current period'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, or GAAP, for interim financial information and the rules and regulations of the SEC. Accordingly, they do not Operating results for the three six June 30, 2021, not may December 31, 2021. December 31, 2020, December 31, 2020, 10 10 December 31, 2020, 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 Significant Accounting Policies The Company’s significant accounting policies are detailed in its Annual Report on Form 10 December 31, 2020. no three six June 30, 2021, 2020 10 Recently Issued Accounting Pronouncements In June 2016, 2016 13, Financial Instruments Credit Losses: Measurement of Credit Losses on Financial Instruments, 2016 13. 2016 13 2016 13 January 1, 2023, January 1, 2020. May 2019, 2019 05, Financial Instruments Credit Losses, 2019 05, 2016 13. 2016 13 2019 05 not In March 2020, 2020 04, Reference Rate Reform (Topic 848 may December 31, 2022. not |
Note 2 - Investments and Fair V
Note 2 - Investments and Fair Value Measurement | 6 Months Ended |
Jun. 30, 2021 | |
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 (loss). Marketable securities which have maturities beyond one The table below summarizes the Company’s cash, cash equivalents and short-term investments (in thousands): As of June 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 1,114 $ — $ — $ 1,114 Money market funds 25,213 — — 25,213 Total cash and cash equivalents 26,327 — — 26,327 Short-term investments: Commercial paper 24,436 — — 24,436 Corporate debt securities 4,562 — — 4,562 Total short-term investments 28,998 — — 28,998 Total cash, cash equivalents and short-term investments $ 55,325 $ — $ — $ 55,325 As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 5,181 $ — $ — $ 5,181 Money market funds 3,996 — — 3,996 Commercial paper 18,097 — — 18,097 Total cash and cash equivalents 27,274 — — 27,274 Short-term investments: U.S. government agency securities 5,818 — — 5,818 Commercial paper 9,794 — — 9,794 Total short-term investments 15,612 — — 15,612 Total cash, cash equivalents and short-term investments $ 42,886 $ — $ — $ 42,886 There were no other-than-temporary impairments for these securities at June 30, 2021 December 31, 2020. no three six June 30, 2021 2020. As of June 30, 2021, December 31, 2020, 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, 2021, December 31, 2020, 5 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, 2021 Fair Value Level I Level II Level III Assets Money market funds $ 25,213 $ 25,213 $ — $ — Commercial paper 24,436 — 24,436 — Corporate debt securities 4,562 — 4,562 — Total assets measured at fair value $ 54,211 $ 25,213 $ 28,998 $ — Liabilities Contingent put option liability $ 128 $ — $ — $ 128 Total liabilities measured at fair value $ 128 $ — $ — $ 128 As of December 31, 2020 Fair Value Level I Level II Level III Assets Money market funds $ 3,996 $ 3,996 $ — $ — U.S. government agency securities 5,818 — 5,818 — Commercial paper 27,891 — 27,891 — Total assets measured at fair value $ 37,705 $ 3,996 $ 33,709 $ — Liabilities Contingent put option liability $ 246 $ — $ — $ 246 Total liabilities measured at fair value $ 246 $ — $ — $ 246 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, 2021 2020 Three Months Ended June 30, 2021 Six Months Ended June 30, 2021 Fair value—beginning of period $ 181 $ 246 Change in fair value of contingent put option associated with the Loan Agreement (53 ) (118 ) Fair value—end of period $ 128 $ 128 Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 Fair value—beginning of period $ 746 $ 437 Change in fair value of contingent put option associated with the Loan Agreement (155 ) 154 Fair value—end of period $ 591 $ 591 |
Note 3 - Inventories, Net
Note 3 - Inventories, Net | 6 Months Ended |
Jun. 30, 2021 | |
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, 2021 December 31, 2020 Raw materials $ 277 $ 257 Work-in-process — 30 Finished goods 1,086 1,339 Total $ 1,363 $ 1,626 The Company recorded inventory impairment charges of $0 and $0.1 million for the three six June 30, 2021, three six June 30, 2020, six June 30, 2020, may |
Note 4 - Revenue From Contracts
Note 4 - Revenue From Contracts With Customers | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 4. The following table summarizes revenue from contracts with customers for the three six June 30, 2021 2020 Three months ended June 30, 2021 Six months ended June 30, 2021 Product sales: DSUVIA $ 392 $ 573 Zalviso — 270 Total product sales 392 843 Contract and collaboration revenue: Non-cash royalty revenue related to Royalty Monetization (Note 7) 38 83 Royalty revenue 13 28 Total revenues from contract and other collaboration 51 111 Total revenue $ 443 $ 954 Three months ended June 30, 2020 Six months ended June 30, 2020 Product sales: DSUVIA $ 2 $ 157 Zalviso 301 420 Total product sales 303 577 Contract and collaboration revenue: Non-cash royalty revenue related to Royalty Monetization (Note 7) 37 121 Royalty revenue 12 40 Other revenue 2,572 2,572 Total revenues from contract and other collaboration 2,621 2,733 Total revenue $ 2,924 $ 3,310 For additional details on the Company’s accounting policy regarding revenue recognition, refer to Note 1 10 December 31, 2020. Product Sales The Company’s commercial launch of DSUVIA in the United States occurred in the first 2019. May 12, 2021. Contract and Other Collaboration Contract and other collaboration revenue includes revenue under the Grünenthal Agreements related to research and development services, non-cash royalty revenue related to the Royalty Monetization and royalty revenue for sales of Zalviso in Europe. Contract Liability The following table presents changes in the Company’s contract liability for the six June 30, 2021 ( Balance at Beginning of the Period Additions Deductions Balance at the end of the Period Contract liability: Deferred revenue – Grünenthal Agreements $ 49 $ — $ (49 ) $ — Deferred revenue $ 49 $ — $ (49 ) $ — For the three six June 30, 2021 2020, Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied $ — $ 154 $ 49 $ 233 Performance obligations eliminated upon termination — 2,572 — 2,572 New activities in the period from performance obligations satisfied: Performance obligations satisfied — 147 221 187 Total revenue from performance obligations satisfied or eliminated $ — $ 2,873 $ 270 $ 2,992 |
Note 5 - Long-term Debt
Note 5 - Long-term Debt | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Long-term Debt [Text Block] | 5. Loan Agreement with Oxford On May 30, 2019, May 30, 2019. In connection with the Loan Agreement, on May 30, 2019, As of June 30, 2021, three six June 30, 2021, three six June 30, 2020, Non-Interest Bearing Payments for the Construction of Leasehold Improvements In August 2019, may four July 2022. June 30, 2021, June 30, 2021 |
Note 6 - Leases
Note 6 - Leases | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 6. Office Leases The Company leased office and laboratory space for its corporate headquarters, located at 301 351 On March 26, 2021, April 30, 2021. six June 30, 2021. April 30, 2021, six June 30, 2021. On March 26, 2021, 25821 April 1, 2021. two three one Contract Manufacturing Leases On April 21, 2021, March 31, 2021, 30 The term of the CSA is for a period of five first two one 24 The Company will pay Catalent an annual fee of $1.0 million beginning January 1, 2022. 10 December 31, 2022, may January 1 January 1, 2023, The Company has determined that the fixed fees in the CSA are in-substance lease payments. The Company concluded that this agreement contains an embedded lease as the clean rooms have been built specifically for production of the Company’s product and their use is effectively controlled by the Company as it has sole use over the space during the term of the agreement. The Company accounts for the agreement as an operating lease and has evaluated the non-cancelable lease term to be through the binding commitment date of May 15, 2027. In addition, the Company has entered into an agreement for commercial supply manufacturing services related to the Company’s Zalviso drug product with a contract manufacturing organization, which it accounts for as an operating lease. The components of lease expense are presented in the following table (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease costs $ 440 $ 269 $ 780 $ 609 Gain on derecognition of operating lease — — (522 ) — Sublease income (50 ) (149 ) (199 ) (299 ) Loss on termination of sublease 331 — 331 — Net lease costs $ 721 $ 120 $ 390 $ 310 The weighted average remaining lease term and discount rate related to the operating leases are presented in the following table: June 30, 2021 Weighted-average remaining term – operating lease (in years) 5.41 Weighted-average discount rate – operating lease 12.80 % Future minimum lease payments as of June 30, 2021 Year: 2021 (remaining nine months) $ 407 2022 1,483 2023 1,144 2024 1,040 2025 1,040 Thereafter 1,454 Total future minimum lease payments 6,568 Less imputed interest (2,453 ) Total $ 4,115 Reported as: Operating lease liabilities $ 4,618 Operating lease liabilities, current portion (503 ) Operating lease liabilities, net of current portion $ 4,115 |
Note 7 - Liability Related to S
Note 7 - Liability Related to Sale of Future Royalties | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Liability Related To Sale Of Future Royalties Disclosure [Text Block] | 7. In September 2015, first four 80% The Company periodically assesses the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments are greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the liability and the effective interest rate. During the three June 30, 2020, November 13, 2020. May 12, 2021 May 12, 2021. may The effective interest rate over the life of the liability will be 0% as we record interest income over the remaining term of the arrangement as an offset to the interest expense that was recognized in prior periods. The effective interest income rate for each of the three six June 30, 2021 2020, The following table shows the activity within the liability account for the six June 30, 2021 ( Six months ended June 30, 2021 Period from inception to June 30, 2021 Liability related to sale of future royalties — beginning balance $ 88,471 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (120 ) (1,058 ) Non-cash interest (income) expense recognized (1,581 ) 26,644 Liability related to sale of future royalties as of June 30, 2021 86,770 86,770 Less: current portion — — Liability related to sale of future royalties — net of current portion $ 86,770 $ 86,770 As royalties are remitted to SWK from ARPI LLC, as described in Note 1 10 December 31, 2020, |
Note 8 - Legal Proceedings
Note 8 - Legal Proceedings | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Legal Matters and Contingencies [Text Block] | 8. On June 8, 2021, 10 20 10b 5 August 9, 2021 December 16, 2021. On July 6, 2021, The Company believes that these lawsuits are without merit, and intends to vigorously defend against them. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, the Company cannot estimate the reasonably possible loss or range of loss that may |
Note 9 - Stockholders' Equity
Note 9 - Stockholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 9. Equity Common Stock Underwritten Public Offering On January 22, 2021, January 27, 2021, ATM Agreement The Company has entered into a Controlled Equity Offering SM may During the three six June 30, 2021, three six June 30, 2020, June 30, 2021, may Amended Stock Plan Amended 2020 On June 17, 2021, 2021 2020 2020 2020 may 2020 not 2020 2020 2011 may 2020 2020 |
Note 10 - Stock-based Compensat
Note 10 - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Share-based Payment Arrangement [Text Block] | 10. The Company recorded total stock-based compensation expense for stock options, stock awards and awards made under the Amended 2011 Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Cost of goods sold $ 21 $ 27 $ 43 $ 73 Research and development 200 184 381 384 Selling, general and administrative 951 879 1,837 1,779 Total $ 1,172 $ 1,090 $ 2,261 $ 2,236 As of June 30, 2021, |
Note 11 - Net Loss Per Share of
Note 11 - Net Loss Per Share of Common Stock | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 11. 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, RSUs, 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 as 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, 2021 2020 ESPP, RSUs and stock options to purchase common stock 16,907,412 14,816,721 Common stock warrants 176,679 176,679 |
Note 12 - Subsequent Events
Note 12 - Subsequent Events | 6 Months Ended |
Jun. 30, 2021 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 12. Out-License Agreement (DZUVEO) On July 14, 2021, The DZUVEO Agreement has an initial term of ten first December 31 December 31, 2022, January 1, 2022 April 30, 2022). five not six 6 The Company is entitled to receive up to € 47.0 Beginning in the third third The DZUVEO Agreement also provides Aguettant with a right of first eighteen 18 In-License Agreement On July 14, 2021, 10 3 10 50 The PFS Agreement has an initial term of ten first December 31 first December 31 first January 1 April 30 five not six 6 Aguettant is entitled to receive up to $24.0 million in sales-based milestone payments. The Company will purchase each product from Aguettant at an agreed price, or the PFS Purchase Price, subject to adjustment. The Company will also make revenue share payments that, combined with the PFS Purchase Price, will range from 40% to 45% of net sales in the United States. The Company and Aguettant will agree on minimum sales obligations twelve The Company has the right to grant sublicenses to its affiliates or, with the prior approval of Aguettant, third |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Business Description of Entity [Policy Text Block] | The Company AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on July 13, 2005 January 2006, AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA® November 2, 2018, first 2019. June 2018, not may one July 2021, 12 May 12, 2021 ( Termination of Gr nenthal Agreements July 2021, 10 3 10 50 12 The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. As of June 30, 2021 December 31, 2020, one 10 September 18, 2015, August 31, 2020, third DSUVIA/DZUVEO DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018 June 2018, DSUVIA was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which restricts distribution to certified medically supervised healthcare settings in order to prevent respiratory depression resulting from accidental exposure. DSUVIA is only distributed to facilities certified in the DSUVIA REMS program following attestation by an authorized representative to comply with appropriate dispensing and use restrictions of DSUVIA. To become certified, a healthcare setting is required to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA is not Zalviso Zalviso delivers 15 September 2013 July 25, 2014. IAP312, IAP312 August 2017, three 3 Termination of Grünenthal Agreements On December 16, 2013, July 17, 2015 September 20, 2016, 28 September 2015, December 16, 2013, July 22, 2015, July 17, 2015. On May 18, 2020, November 13, 2020. May 12, 2021 May 12, 2021. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The Condensed Consolidated Financial Statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note 7 |
Reclassification, Comparability Adjustment [Policy Text Block] | Reclassifications Certain prior period amounts in the Condensed Consolidated Financial Statements have been reclassified to conform to the current period'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, or GAAP, for interim financial information and the rules and regulations of the SEC. Accordingly, they do not Operating results for the three six June 30, 2021, not may December 31, 2021. December 31, 2020, December 31, 2020, 10 10 December 31, 2020, |
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 |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Issued Accounting Pronouncements In June 2016, 2016 13, Financial Instruments Credit Losses: Measurement of Credit Losses on Financial Instruments, 2016 13. 2016 13 2016 13 January 1, 2023, January 1, 2020. May 2019, 2019 05, Financial Instruments Credit Losses, 2019 05, 2016 13. 2016 13 2019 05 not In March 2020, 2020 04, Reference Rate Reform (Topic 848 may December 31, 2022. not |
Note 2 - Investments and Fair_2
Note 2 - Investments and Fair Value Measurement (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Cash, Cash Equivalents and Investments [Table Text Block] | As of June 30, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 1,114 $ — $ — $ 1,114 Money market funds 25,213 — — 25,213 Total cash and cash equivalents 26,327 — — 26,327 Short-term investments: Commercial paper 24,436 — — 24,436 Corporate debt securities 4,562 — — 4,562 Total short-term investments 28,998 — — 28,998 Total cash, cash equivalents and short-term investments $ 55,325 $ — $ — $ 55,325 As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash and cash equivalents: Cash $ 5,181 $ — $ — $ 5,181 Money market funds 3,996 — — 3,996 Commercial paper 18,097 — — 18,097 Total cash and cash equivalents 27,274 — — 27,274 Short-term investments: U.S. government agency securities 5,818 — — 5,818 Commercial paper 9,794 — — 9,794 Total short-term investments 15,612 — — 15,612 Total cash, cash equivalents and short-term investments $ 42,886 $ — $ — $ 42,886 |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | As of June 30, 2021 Fair Value Level I Level II Level III Assets Money market funds $ 25,213 $ 25,213 $ — $ — Commercial paper 24,436 — 24,436 — Corporate debt securities 4,562 — 4,562 — Total assets measured at fair value $ 54,211 $ 25,213 $ 28,998 $ — Liabilities Contingent put option liability $ 128 $ — $ — $ 128 Total liabilities measured at fair value $ 128 $ — $ — $ 128 As of December 31, 2020 Fair Value Level I Level II Level III Assets Money market funds $ 3,996 $ 3,996 $ — $ — U.S. government agency securities 5,818 — 5,818 — Commercial paper 27,891 — 27,891 — Total assets measured at fair value $ 37,705 $ 3,996 $ 33,709 $ — Liabilities Contingent put option liability $ 246 $ — $ — $ 246 Total liabilities measured at fair value $ 246 $ — $ — $ 246 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | Three Months Ended June 30, 2021 Six Months Ended June 30, 2021 Fair value—beginning of period $ 181 $ 246 Change in fair value of contingent put option associated with the Loan Agreement (53 ) (118 ) Fair value—end of period $ 128 $ 128 Three Months Ended June 30, 2020 Six Months Ended June 30, 2020 Fair value—beginning of period $ 746 $ 437 Change in fair value of contingent put option associated with the Loan Agreement (155 ) 154 Fair value—end of period $ 591 $ 591 |
Note 3 - Inventories, Net (Tabl
Note 3 - Inventories, Net (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | Balance as of June 30, 2021 December 31, 2020 Raw materials $ 277 $ 257 Work-in-process — 30 Finished goods 1,086 1,339 Total $ 1,363 $ 1,626 |
Note 4 - Revenue From Contrac_2
Note 4 - Revenue From Contracts With Customers (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | Three months ended June 30, 2021 Six months ended June 30, 2021 Product sales: DSUVIA $ 392 $ 573 Zalviso — 270 Total product sales 392 843 Contract and collaboration revenue: Non-cash royalty revenue related to Royalty Monetization (Note 7) 38 83 Royalty revenue 13 28 Total revenues from contract and other collaboration 51 111 Total revenue $ 443 $ 954 Three months ended June 30, 2020 Six months ended June 30, 2020 Product sales: DSUVIA $ 2 $ 157 Zalviso 301 420 Total product sales 303 577 Contract and collaboration revenue: Non-cash royalty revenue related to Royalty Monetization (Note 7) 37 121 Royalty revenue 12 40 Other revenue 2,572 2,572 Total revenues from contract and other collaboration 2,621 2,733 Total revenue $ 2,924 $ 3,310 |
Contract with Customer, Contract Asset, Contract Liability, and Receivable [Table Text Block] | Balance at Beginning of the Period Additions Deductions Balance at the end of the Period Contract liability: Deferred revenue – Grünenthal Agreements $ 49 $ — $ (49 ) $ — Deferred revenue $ 49 $ — $ (49 ) $ — Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied $ — $ 154 $ 49 $ 233 Performance obligations eliminated upon termination — 2,572 — 2,572 New activities in the period from performance obligations satisfied: Performance obligations satisfied — 147 221 187 Total revenue from performance obligations satisfied or eliminated $ — $ 2,873 $ 270 $ 2,992 |
Note 6 - Leases (Tables)
Note 6 - Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease costs $ 440 $ 269 $ 780 $ 609 Gain on derecognition of operating lease — — (522 ) — Sublease income (50 ) (149 ) (199 ) (299 ) Loss on termination of sublease 331 — 331 — Net lease costs $ 721 $ 120 $ 390 $ 310 June 30, 2021 Weighted-average remaining term – operating lease (in years) 5.41 Weighted-average discount rate – operating lease 12.80 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Year: 2021 (remaining nine months) $ 407 2022 1,483 2023 1,144 2024 1,040 2025 1,040 Thereafter 1,454 Total future minimum lease payments 6,568 Less imputed interest (2,453 ) Total $ 4,115 Operating lease liabilities $ 4,618 Operating lease liabilities, current portion (503 ) Operating lease liabilities, net of current portion $ 4,115 |
Note 7 - Liability Related to_2
Note 7 - Liability Related to Sale of Future Royalties (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Other Liabilities [Table Text Block] | Six months ended June 30, 2021 Period from inception to June 30, 2021 Liability related to sale of future royalties — beginning balance $ 88,471 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue (120 ) (1,058 ) Non-cash interest (income) expense recognized (1,581 ) 26,644 Liability related to sale of future royalties as of June 30, 2021 86,770 86,770 Less: current portion — — Liability related to sale of future royalties — net of current portion $ 86,770 $ 86,770 |
Note 10 - Stock-based Compens_2
Note 10 - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Cost of goods sold $ 21 $ 27 $ 43 $ 73 Research and development 200 184 381 384 Selling, general and administrative 951 879 1,837 1,779 Total $ 1,172 $ 1,090 $ 2,261 $ 2,236 |
Note 11 - Net Loss Per Share _2
Note 11 - Net Loss Per Share of Common Stock (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | June 30, 2021 2020 ESPP, RSUs and stock options to purchase common stock 16,907,412 14,816,721 Common stock warrants 176,679 176,679 |
Note 1 - Organization and Sum_2
Note 1 - Organization and Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Cash, Cash Equivalents, and Short-term Investments, Total | $ 55.3 | $ 42.9 |
Note 2 - Investments and Fair_3
Note 2 - Investments and Fair Value Measurement (Details Textual) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Other than Temporary Impairment Losses, Investments, Available-for-sale Securities, Total | $ 0 | $ 0 | |
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | $ 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, 2021 | Dec. 31, 2020 |
Amortized Cost | $ 55,325 | $ 42,886 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 55,325 | 42,886 |
Cash and Cash Equivalents [Member] | ||
Amortized Cost | 26,327 | 27,274 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 26,327 | 27,274 |
Cash and Cash Equivalents [Member] | Cash [Member] | ||
Amortized Cost | 1,114 | 5,181 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 1,114 | 5,181 |
Cash and Cash Equivalents [Member] | Money Market Funds [Member] | ||
Amortized Cost | 25,213 | 3,996 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 25,213 | 3,996 |
Cash and Cash Equivalents [Member] | Commercial Paper [Member] | ||
Amortized Cost | 24,436 | 18,097 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 24,436 | 18,097 |
Cash and Cash Equivalents [Member] | U.S. Government Agency Securities [Member] | ||
Amortized Cost | 5,818 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | 5,818 | |
Marketable Securities [Member] | ||
Amortized Cost | 28,998 | 15,612 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Fair Value | 28,998 | 15,612 |
Marketable Securities [Member] | Commercial Paper [Member] | ||
Amortized Cost | 9,794 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 9,794 | |
Marketable Securities [Member] | Corporate Debt Securities [Member] | ||
Amortized Cost | 4,562 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | 0 | |
Fair Value | $ 4,562 |
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, 2021 | Dec. 31, 2020 |
Assets, fair value | $ 54,211 | $ 37,705 |
Liabilities, fair value | 128 | 246 |
Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 128 | 246 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 25,213 | 3,996 |
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 28,998 | 33,709 |
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | 0 |
Liabilities, fair value | 128 | 246 |
Fair Value, Inputs, Level 3 [Member] | Contingent Put Option Liability [Member] | ||
Liabilities, fair value | 128 | 246 |
Money Market Funds [Member] | ||
Assets, fair value | 25,213 | 3,996 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 25,213 | 3,996 |
Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 0 | 0 |
Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | 0 |
Commercial Paper [Member] | ||
Assets, fair value | 24,436 | 27,891 |
Commercial Paper [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | 0 |
Commercial Paper [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 24,436 | 27,891 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | 0 |
U.S. Government Agency Securities [Member] | ||
Assets, fair value | 5,818 | |
U.S. Government Agency Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | |
U.S. Government Agency Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 5,818 | |
U.S. Government Agency Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | $ 0 | |
Corporate Debt Securities [Member] | ||
Assets, fair value | 4,562 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 4,562 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | $ 0 |
Note 2 - Investments and Fair_6
Note 2 - Investments and Fair Value Measurement - Summary of Changes in Fair Value of Level III Financial Liabilities (Details) - Fair Value, Inputs, Level 3 [Member] - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Fair value, Beginning of period | $ 181 | $ 746 | $ 246 | $ 437 |
Change in fair value of contingent put option associated with the Loan Agreement | (53) | (118) | ||
Change in fair value of contingent put option associated with the Loan Agreement | (155) | 154 | ||
Fair value, End of period | $ 128 | $ 591 | $ 128 | $ 591 |
Note 3 - Inventories, Net (Deta
Note 3 - Inventories, Net (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
ZALVISO [Member] | ||||
Inventory Write-down | $ 0 | $ 300 | $ 100 | $ 400 |
Amended License Agreement [Member] | ||||
Inventory Write-down | 300 | |||
DSUVIA [Member] | ||||
Inventory Write-down | $ 100 |
Note 3 - Inventories, Net - Inv
Note 3 - Inventories, Net - Inventory Components (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | |
Raw materials | $ 277 | $ 257 | |
Work-in-process | 0 | 30 | |
Finished goods | 1,086 | 1,339 | |
Total | $ 1,363 | $ 1,626 | [1] |
[1] | The condensed consolidated balance sheet as of December 31, 2020 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, 2020. |
Note 4 - Revenue From Contrac_3
Note 4 - Revenue From Contracts With Customers - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue | $ 443 | $ 2,924 | $ 954 | $ 3,310 |
DSUVIA [Member] | ||||
Revenue | 392 | 2 | 573 | 157 |
ZALVISO [Member] | ||||
Revenue | 0 | 301 | 270 | 420 |
Product [Member] | ||||
Revenue | 392 | 303 | 843 | 577 |
Non-cash Royalty [Member] | ||||
Revenue | 38 | 37 | 83 | 121 |
Royalty [Member] | ||||
Revenue | 13 | 12 | 28 | 40 |
Contract and Other Collaboration [Member] | ||||
Revenue | $ 51 | 2,621 | $ 111 | 2,733 |
Contract and Other Revenue [Member] | ||||
Revenue | $ 2,572 | $ 2,572 |
Note 4 - Revenue From Contrac_4
Note 4 - Revenue From Contracts With Customers - Changes in Contract Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Contract Liabilities: Deferred Revenue | $ 49 | |||
Revenue | $ 443 | $ 2,924 | 954 | $ 3,310 |
Contract Liabilities: Deferred Revenue, Additions | 0 | |||
Contract Liabilities: Deferred Revenue, Deductions | (49) | |||
Contract Liabilities: Deferred Revenue | 0 | 0 | ||
Amended License Agreement [Member] | ||||
Contract Liabilities: Deferred Revenue | 49 | |||
Amounts included in contract liabilities at the beginning of the period: Performance obligations satisfied | 0 | 154 | 49 | 233 |
Performance obligations eliminated upon termination | 0 | 2,572 | 0 | 2,572 |
New activities in the period from performance obligations satisfied: Performance obligations satisfied | 0 | 147 | 221 | 187 |
Revenue | 0 | $ 2,873 | 270 | $ 2,992 |
Contract Liabilities: Deferred Revenue, Additions | 0 | |||
Contract Liabilities: Deferred Revenue, Deductions | (49) | |||
Contract Liabilities: Deferred Revenue | $ 0 | $ 0 |
Note 5 - Long-term Debt (Detail
Note 5 - Long-term Debt (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Aug. 01, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | May 30, 2019 |
Amortization of Debt Discount (Premium) | $ 430 | $ 558 | ||||
Leasehold Improvements [Member] | ||||||
Capital Leases, Balance Sheet, Assets by Major Class, Net, Total | $ 1,700 | 1,700 | ||||
Site Readiness Agreement [Member] | ||||||
Debt Instrument, Periodic Payment, Principal | $ 500 | |||||
Total Obligation Under Leasehold Agreement | $ 900 | $ 900 | ||||
Debt Instrument, Interest Rate, Effective Percentage | 14.35% | 14.35% | ||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | ||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 176,679 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 2.83 | |||||
Loan Agreement with Oxford Finance LLC [Member] | ||||||
Debt Instrument, Face Amount | $ 25,000 | |||||
Long-term Debt, Total | $ 17,200 | $ 17,200 | ||||
Interest Expense, Debt, Total | 600 | $ 900 | 1,200 | 1,700 | ||
Amortization of Debt Discount (Premium) | $ 200 | $ 300 | $ 400 | $ 500 |
Note 6 - Leases (Details Textua
Note 6 - Leases (Details Textual) - USD ($) | Apr. 21, 2021 | Mar. 26, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Apr. 30, 2021 | Dec. 31, 2020 | [1] | Feb. 16, 2019 |
Percentage of Office and Laboratory Space Sublease | 47.00% | |||||||||
Gain (Loss) on Termination of Lease | $ 500,000 | $ 0 | $ 0 | $ 522,000 | $ 0 | |||||
Operating Lease, Right-of-Use Asset | $ 4,607,000 | $ 4,607,000 | $ 3,150,000 | |||||||
Catalent Pharma Solutions [Member] | ||||||||||
Commercial Supply Agreement, Term (Year) | 5 years | |||||||||
Commercial Supply Agreement, Extended Term (Year) | 2 years | |||||||||
Commercial Supply Agreement, Annual Fee | $ 1,000,000 | |||||||||
Lease for Corporate Headquarters in Hayward, California [Member] | ||||||||||
Lessee, Operating Lease, Term of Contract (Year) | 2 years 3 months | |||||||||
Lessee, Operating Lease, Monthly Rent | $ 17,000 | |||||||||
Lessee, Operating Lease, Abated Rent Period (Month) | 1 month | |||||||||
Operating Lease, Right-of-Use Asset | $ 400,000 | |||||||||
Prepaid Expenses and Other Current Assets [Member] | ||||||||||
Lessee, Operating Sublease, Deferred Costs | $ 300,000 | |||||||||
[1] | The condensed consolidated balance sheet as of December 31, 2020 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, 2020. |
Note 6 - Leases - Operating Lea
Note 6 - Leases - Operating Lease Costs (Details) - USD ($) $ in Thousands | Mar. 26, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Operating lease costs | $ 440 | $ 269 | $ 780 | $ 609 | |
Gain on derecognition of operating lease | $ (500) | 0 | 0 | (522) | 0 |
Sublease income | (50) | (149) | (199) | (299) | |
Loss on termination of sublease | 331 | 0 | 331 | 0 | |
Net lease costs | $ 721 | $ 120 | $ 390 | $ 310 | |
Weighted-average remaining term – operating lease (in years) (Year) | 5 years 4 months 28 days | 5 years 4 months 28 days | |||
Weighted-average discount rate – operating lease | 12.80% | 12.80% |
Note 6 - Leases - Maturities of
Note 6 - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | [1] |
2021 (remaining nine months) | $ 407 | ||
2022 | 1,483 | ||
2023 | 1,144 | ||
2024 | 1,040 | ||
2025 | 1,040 | ||
Thereafter | 1,454 | ||
Total future minimum lease payments | 6,568 | ||
Less imputed interest | (2,453) | ||
Total | 4,115 | $ 2,606 | |
Operating lease liabilities | 4,618 | ||
Operating lease liabilities, current portion | (503) | (1,118) | |
Operating lease liabilities, net of current portion | $ 4,115 | $ 2,606 | |
[1] | The condensed consolidated balance sheet as of December 31, 2020 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, 2020. |
Note 7 - Liability Related to_3
Note 7 - Liability Related to Sale of Future Royalties (Details Textual) - USD ($) $ in Millions | Sep. 18, 2015 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Proceeds From Sale of Royalty and Milestone Rights | $ 65 | ||||
Royalty Arrangment Maximum Payments | $ 195 | ||||
Contingent Gain (Loss) on Royalty Monetization Arrangement | $ 65 | ||||
Effective Interest Over Life of Liability Related to Sale of Future Royalties | 0.00% | ||||
Effective Annual Interest Rate | 3.60% | 3.60% | 3.60% | 3.60% | |
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 7 - Liability Related to_4
Note 7 - Liability Related to Sale of Future Royalties - Activity of Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 69 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Dec. 31, 2020 | [1] | |
Liability related to sale of future royalties — beginning balance | $ 88,471 | $ 0 | |||||
Proceeds from sale of future royalties | 0 | 61,184 | |||||
Non-cash royalty revenue | (120) | (1,058) | |||||
Non-cash interest (income) expense recognized | $ (799) | $ (834) | (1,581) | $ (1,677) | 26,644 | ||
Liability related to sale of future royalties as of June 30, 2021 | 86,770 | 86,770 | 86,770 | ||||
Less: current portion | 0 | 0 | 0 | ||||
Liability related to sale of future royalties — net of current portion | $ 86,770 | $ 86,770 | $ 86,770 | $ 88,365 | |||
[1] | The condensed consolidated balance sheet as of December 31, 2020 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, 2020. |
Note 8 - Legal Proceedings (Det
Note 8 - Legal Proceedings (Details Textual) | Jul. 06, 2021 | Jun. 08, 2021 |
Purported Shareholder v. Company - Violation of Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 [Member] | ||
Loss Contingency, Number of Defendants | 2 | |
Purported Shareholder v. Company - Alleged Misstatements as the Shareholder [Member] | Subsequent Event [Member] | ||
Loss Contingency, Number of Defendants | 10 |
Note 9 - Stockholders' Equity (
Note 9 - Stockholders' Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | Jun. 17, 2021 | Jan. 27, 2021 | Jan. 27, 2021 | Jan. 22, 2021 | May 09, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 16, 2020 |
Proceeds from Issuance of Common Stock | $ 36,360 | $ 1,449 | ||||||||
The 2020 Equity Incentive Plan [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized (in shares) | 4,300,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 5,500,000 | |||||||||
The 2020 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in shares) | 4,300,000 | |||||||||
Private Placement [Member] | Armistice Capital and Rock Springs Capital [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 16,675,000 | 2,175,000 | 14,500,000 | |||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1.7625 | $ 1.7625 | $ 1.7625 | |||||||
Proceeds from Issuance of Common Stock | $ 28,900 | |||||||||
ATM Agreement [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 3,000,000 | 445,000 | 3,000,000 | 876,800 | ||||||
Aggregate Offering Price, Maximum | $ 80,000 | $ 36,100 | ||||||||
Proceeds from Issuance of Common Stock, Net | $ 7,500 | $ 700 | $ 7,500 | $ 1,500 |
Note 10 - Stock-based Compens_3
Note 10 - Stock-based Compensation (Details Textual) - The 2020 Equity Incentive Plan [Member] | Jun. 30, 2021shares |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in shares) | 7,589,292 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance (in shares) | 14,790,044 |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number, Ending Balance (in shares) | 1,834,228 |
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, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock-based compensation expense | $ 1,172 | $ 1,090 | $ 2,261 | $ 2,236 |
Cost of Sales [Member] | ||||
Stock-based compensation expense | 21 | 27 | 43 | 73 |
Research and Development Expense [Member] | ||||
Stock-based compensation expense | 200 | 184 | 381 | 384 |
Selling, General and Administrative Expenses [Member] | ||||
Stock-based compensation expense | $ 951 | $ 879 | $ 1,837 | $ 1,779 |
Note 11 - Net Loss Per Share _3
Note 11 - 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, 2021 | Jun. 30, 2020 | |
RSU's, ESPP, and Employee Stock Options [Member] | ||
Antidilutive securities (in shares) | 16,907,412 | 14,816,721 |
Warrant [Member] | ||
Antidilutive securities (in shares) | 176,679 | 176,679 |
Note 12 - Subsequent Events (De
Note 12 - Subsequent Events (Details Textual) - Jul. 14, 2021 - Aguettant [Member] - Subsequent Event [Member] € in Millions, $ in Millions | USD ($) | EUR (€) |
DZUVEO [Member] | ||
License Agreement, Term (Year) | 10 years | |
License Agreement, Renewal Term (Year) | 5 years | |
License Agreement, Upfront and Maximum Milestone Payments to be Received | € | € 47 | |
DZUVEO [Member] | Minimum [Member] | ||
License Agreement, Percent of Revenue Share Payments to be Received | 35.00% | |
DZUVEO [Member] | Maximum [Member] | ||
License Agreement, Percent of Revenue Share Payments to be Received | 45.00% | |
PFS Products [Member] | ||
License Agreement, Term (Year) | 10 years | |
License Agreement, Renewal Term (Year) | 5 years | |
License Agreement, Milestone Payments to be Paid, Maximum | $ | $ 24 | |
License Agreement, Minimum Sales Obligation Term (Month) | 12 months | |
PFS Products [Member] | Minimum [Member] | ||
License Agreement, Percent of Revenue Share Payment to be Paid | 40.00% | |
PFS Products [Member] | Maximum [Member] | ||
License Agreement, Percent of Revenue Share Payment to be Paid | 45.00% |