Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 20, 2023 | Jun. 30, 2022 | |
Document Information [Line Items] | |||
Entity Central Index Key | 0001427925 | ||
Entity Registrant Name | ACELRX PHARMACEUTICALS INC | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 35,604,258 | ||
Entity Common Stock, Shares Outstanding | 10,918,452 | ||
Auditor Name | WithumSmith+Brown, PC | ||
Auditor Location | San Francisco, California | ||
Auditor Firm ID | 100 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | ||
Current Assets: | ||||
Cash and cash equivalents | $ 15,275 | $ 7,663 | [1] | |
Restricted cash | 5,000 | 0 | ||
Short-term investments | 495 | 38,967 | [1] | |
Accounts receivable, net | 309 | 160 | [1] | |
Inventories, net | 1,178 | 1,111 | [1] | |
Prepaid expenses and other current assets | 2,309 | 2,588 | [1] | |
Total current assets | 24,566 | 50,489 | [1] | |
Operating lease right-of-use assets | 3,595 | 4,302 | [1] | |
Property and equipment, net | 10,261 | 15,928 | [1] | |
In-process research and development asset | 8,819 | 0 | ||
Other assets | 246 | 2,174 | [1] | |
Restricted cash, net of current portion | 0 | 5,000 | ||
Total assets | 47,487 | 77,893 | [1] | |
Current Liabilities: | ||||
Accounts payable | 2,040 | 2,121 | [1] | |
Accrued and other liabilities | 4,266 | 6,524 | [1] | |
Long-term debt, current portion | 5,763 | 8,796 | [1] | |
Operating lease liabilities, current portion | 1,701 | 1,068 | [1] | |
Total current liabilities | 13,770 | 18,509 | [1] | |
Long-term debt, net of current portion | 0 | 5,007 | [1] | |
Deferred revenue, net of current portion | 1,036 | 1,151 | ||
Operating lease liabilities, net of current portion | 2,959 | 3,750 | [1] | |
Warrant liability | 7,098 | 0 | ||
Liability related to the sale of future royalties | 0 | 85,288 | [1] | |
Other long-term liabilities | 810 | 81 | [1] | |
Total liabilities | 25,673 | 113,786 | [1] | |
Commitments and Contingencies | ||||
Common stock, $0.001 par value—200,000,000 shares authorized as of December 31, 2022 and 2021; 8,243,680 and 6,840,967 shares issued and outstanding as of December 31, 2022 and 2021, respectively | [2] | 8 | 7 | [1] |
Additional paid-in capital | [2] | 447,635 | 437,684 | [1] |
Accumulated deficit | [2] | (425,829) | (473,584) | [1] |
Total stockholders’ equity (deficit) | [2] | 21,814 | (35,893) | |
Total Liabilities and Stockholders’ Equity (Deficit) | $ 47,487 | $ 77,893 | ||
[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.[2]Adjusted to give retroactive effect to a 1-for-20 reverse stock split effective as of 5:01 p.m. Eastern Time on October 25, 2022. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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) | 8,243,680 | 6,840,967 |
Common stock, shares outstanding (in shares) | 8,243,680 | 6,840,967 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue: | ||
Revenue | $ 1,771 | $ 2,818 |
Operating costs and expenses: | ||
Cost of goods sold | 2,591 | 3,753 |
Research and development | 5,193 | 4,095 |
Selling, general and administrative | 25,672 | 30,935 |
Impairment of property and equipment | 4,948 | 0 |
Total operating costs and expenses | 38,404 | 38,783 |
Loss from operations | (36,633) | (35,965) |
Other income: | ||
Interest expense | (1,153) | (2,291) |
Interest income and other income, net | 366 | 124 |
Non-cash interest income on liability related to sale of future royalties | 1,136 | 3,038 |
Gain on extinguishment of liability related to the sale of future royalties | 84,052 | 0 |
Total other income | 84,401 | 871 |
Net income (loss) before provision for income taxes | 47,768 | (35,094) |
Provision for income taxes | 13 | 5 |
Net income (loss) | 47,755 | (35,099) |
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | (186) | 0 |
Income allocated to participating securities | (5,240) | 0 |
Net income (loss) attributable to Common Shareholders, basic | $ 42,329 | $ (35,099) |
Net income (loss) per share of common stock, basic (in dollars per share) | $ 5.73 | $ (5.86) |
Shares used in computing net income (loss) per share of common stock, basic–(Note 16) (in shares) | 7,385,348 | 5,993,013 |
Net income (loss) attributable to Common Shareholders, diluted | $ 42,342 | $ (35,099) |
Net income (loss) per share of common stock, diluted (in dollars per share) | $ 5.72 | $ (5.86) |
Shares used in computing net income (loss) per share of common stock, diluted –(Note 16) (in shares) | 7,406,986 | 5,993,013 |
Product [Member] | ||
Revenue: | ||
Revenue | $ 1,771 | $ 1,005 |
Contract and Other Collaboration [Member] | ||
Revenue: | ||
Revenue | $ 0 | $ 1,813 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Redeemable Convertible Preferred Stock [Member] Preferred Stock [Member] | Redeemable Convertible Preferred Stock [Member] Common Stock [Member] | Redeemable Convertible Preferred Stock [Member] Additional Paid-in Capital [Member] | Redeemable Convertible Preferred Stock [Member] Retained Earnings [Member] | Redeemable Convertible Preferred Stock [Member] | Preferred Stock [Member] | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total | |
Balance (in shares) at Dec. 31, 2020 | 0 | 4,940,590 | |||||||||
Balance at Dec. 31, 2020 | $ 0 | $ 5 | $ 382,730 | $ (438,485) | $ (55,750) | ||||||
Stock-based compensation | $ 0 | $ 0 | 4,609 | 0 | 4,609 | ||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes (in shares) | 0 | 24,433 | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes | $ 0 | $ 0 | (249) | 0 | (249) | ||||||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 0 | 1,860,078 | |||||||||
Stock Issued During Period, Value, New Issues | $ 0 | $ 2 | 44,714 | 0 | 44,716 | ||||||
Stock Issued During Period, Shares, New Issues (in shares) | 0 | 1,860,078 | |||||||||
Net proceeds from issuance of warrants in connection with equity financings | $ 0 | $ 0 | 5,562 | 0 | 5,562 | ||||||
Issuance of common stock upon exercise of stock options (in shares) | 0 | 969 | |||||||||
Issuance of common stock upon exercise of stock options | $ 0 | $ 0 | 17 | 0 | 17 | ||||||
Issuance of common stock upon ESPP purchase (in shares) | 0 | 14,897 | |||||||||
Issuance of common stock upon ESPP purchase | $ 0 | $ 0 | 301 | 0 | 301 | ||||||
Net income (loss) | 0 | 0 | 0 | (35,099) | (35,099) | ||||||
Issuance of Series A Redeemable Convertible Preferred Stock and Warrants | $ 0 | $ 2 | 44,714 | 0 | 44,716 | ||||||
Balance (in shares) at Dec. 31, 2021 | 0 | 6,840,967 | |||||||||
Balance at Dec. 31, 2021 | $ 0 | $ 7 | 437,684 | (473,584) | (35,893) | [1] | |||||
Stock-based compensation | $ 0 | $ 0 | 2,889 | 0 | 2,889 | ||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes (in shares) | 0 | 37,672 | |||||||||
Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes | $ 0 | $ 0 | (58) | 0 | (58) | ||||||
Net proceeds from issuance of common stock in connection with equity financings (in shares) | 3,000 | 0 | 0 | 873,074 | |||||||
Stock Issued During Period, Value, New Issues | $ 129 | $ 0 | $ 110 | $ 0 | $ 110 | $ 0 | $ 1 | 789 | 0 | $ 790 | |
Stock Issued During Period, Shares, New Issues (in shares) | 3,000 | 0 | 0 | 873,074 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 0 | ||||||||||
Issuance of common stock upon ESPP purchase (in shares) | 0 | 10,941 | |||||||||
Issuance of common stock upon ESPP purchase | $ 0 | $ 0 | 74 | 0 | $ 74 | ||||||
Net income (loss) | 0 | 0 | 0 | 47,755 | 47,755 | ||||||
Issuance of Series A Redeemable Convertible Preferred Stock and Warrants | $ 129 | $ 0 | $ 110 | $ 0 | $ 110 | 0 | $ 1 | 789 | 0 | 790 | |
Deemed dividends related to Series A Redeemable Convertible Preferred Stock | $ 186 | ||||||||||
Deemed dividends related to Series A Redeemable Convertible Preferred Stock | (186) | (186) | |||||||||
Redemption of Series A Redeemable Convertible Preferred Stock and Warrants (in shares) | (3,000) | 0 | |||||||||
Redemption of Series A Redeemable Convertible Preferred Stock and Warrants | $ (315) | $ 0 | 0 | 0 | 0 | ||||||
Issuance of common stock in connection with asset purchase (in shares) | 0 | 481,026 | |||||||||
Issuance of common stock in connection with asset purchase | $ 0 | $ 0 | 5,511 | 0 | 5,511 | ||||||
Modification of equity-classified warrants | $ 0 | $ 0 | 822 | 0 | 822 | ||||||
Balance (in shares) at Dec. 31, 2022 | 0 | 8,243,680 | |||||||||
Balance at Dec. 31, 2022 | $ 0 | $ 8 | $ 447,635 | $ (425,829) | $ 21,814 | [1] | |||||
[1]Adjusted to give retroactive effect to a 1-for-20 reverse stock split effective as of 5:01 p.m. Eastern Time on October 25, 2022. |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ 47,755 | $ (35,099) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Non-cash royalty revenue related to royalty monetization | 0 | (83) |
Non-cash interest income on liability related to royalty monetization | (1,136) | (3,038) |
Depreciation and amortization | 1,647 | 1,973 |
Non-cash interest expense related to debt financing | 393 | 761 |
Non-cash issuance costs for warrant liability | 775 | 0 |
Stock-based compensation | 2,889 | 4,609 |
Non-cash gain on termination of liability related to royalty monetization | (84,152) | 0 |
Impairment of property and equipment | 4,948 | 0 |
Inventory impairment charge | 0 | 810 |
Other | (60) | (138) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (149) | 475 |
Inventories | (107) | (295) |
Prepaid expenses and other assets | 299 | (908) |
Accounts payable | 551 | 111 |
Accrued liabilities | (1,613) | 79 |
Operating lease liabilities | (285) | (447) |
Deferred revenue | (86) | 1,188 |
Net cash used in operating activities | (28,331) | (30,002) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (364) | (1,827) |
Purchase of investments | (7,861) | (70,459) |
Cash paid for asset acquisition, net of cash acquired | (1,687) | (821) |
Proceeds from sale of investments | 0 | 2,996 |
Proceeds from maturities of investments | 46,362 | 43,988 |
Net cash provided by (used in) investing activities | 36,450 | (26,123) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of long-term debt | (8,433) | (8,833) |
Net proceeds from issuance of Series A Redeemable Convertible Preferred Stock and Warrants | 239 | 0 |
Redemption of Series A Redeemable Convertible Preferred Stock | (315) | 0 |
Net proceeds from issuance of common stock through equity plans | 74 | 318 |
Tax payments related to shares withheld for restricted stock units vested | (58) | (249) |
Net cash (used in) provided by financing activities | (507) | 41,514 |
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | 7,612 | (14,611) |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH —Beginning of year | 12,663 | 27,274 |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH —End of year | 20,275 | 12,663 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||
Cash paid for interest | 824 | 1,595 |
Income taxes paid | 13 | 5 |
NONCASH INVESTING AND FINANCING ACTIVITIES: | ||
Purchases of property and equipment in accounts payable and accrued expenses | 825 | 1,095 |
Equity issuance costs from modification of November 2021 Financing Warrants | 47 | 0 |
Equity issuance costs in accounts payable and accrued expenses | 51 | 0 |
Liability for held back shares in connection with asset acquisition in other long-term liabilities | 800 | 0 |
Issuance of common stock in connection with asset acquisition | 5,511 | 0 |
Asset acquisition costs in accounts payable and accrued expenses | 0 | 1,087 |
Establishment of right-of-use asset and lease liability | 127 | 4,669 |
Write-off of right-of-use asset and lease liability | 0 | (3,128) |
Gain on termination of sublease | 0 | 522 |
2021 Registered Direct Offering [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock | 7,528 | 0 |
Net proceeds from issuance of common stock and warrants | 0 | 13,918 |
Underwritten Public Offering [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net proceeds from issuance of common stock and warrants | 0 | 28,886 |
ATM Agreement [Member] | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock | $ 458 | $ 7,474 |
Note 1 - Organization and Summa
Note 1 - Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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 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, May 12, 2021 ( Termination of Gr nenthal Agreements July 2022, On March 12, 2023, 30 20, In July 2021, 20, In July 2021, 10 3 10 50 20, On January 7, 2022, 4, 10 not 8 608, Termination of Gr nenthal Agreements On December 16, 2013, July 17, 2015, September 20, 2016, September 2015, December 16, 2013, July 15, 2015, On May 18, 2020, November 13, 2020. May 12, 2021 May 12, 2021. July 2022, Termination of Royalty Monetization On September 18, 2015, August 31, 2020, May 31, 2022, May 31, 2022, no Liquidity and Going Concern The consolidated financial statements for the year ended December 31, 2022 December 31, 2022; twelve 12 10 may SM third not may not not may third may may not Reverse Stock Split On September 23, 2022, 1 1 1 20, October 25, 2022, one not As the par value per share of the Company's common stock remained unchanged at $0.001 per share, the change in the common stock recorded at par value has been reclassified to additional paid-in capital on a retroactive basis. All references to shares of common stock, stock options, restricted stock units and warrants and per share data for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted to reflect the Reverse Stock Split on a retroactive basis. Basis of Presentation The preparation of financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. Reclassifications Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year's presentation. In particular, the restricted cash classified as “Cash and cash equivalents” has been reclassified to “Restricted cash, net of current portion” in the consolidated balance sheets as of December 31, 2021 December 31, 2022 December 31, 2021. Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management believes its most significant accounting estimates relate to revenue recognition, inventory valuation and the liability related to the sale of future royalties. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not Cash, Cash Equivalents, Restricted Cash and Short-Term Investments The Company considers all highly liquid investments with an original maturity (at date of purchase) of three On May 30, 2019, not The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts in the consolidated statements of cash flows: Balance as of December 31, 2022 December 31, 2021 Cash and cash equivalents $ 15,275 $ 7,663 Restricted cash 5,000 — Restricted cash, net of current portion — 5,000 Total cash, cash equivalents, and restricted cash $ 20,275 $ 12,663 All marketable securities are classified as available for sale and consist of commercial paper, U.S. government sponsored enterprise debt securities and corporate debt securities. These securities are carried at estimated fair value, which is based on quoted market prices or observable market inputs of almost identical assets, with unrealized gains and losses included in accumulated other comprehensive income (loss). The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income or expense. The cost of securities sold is based on specific identification. The Company’s investments are subject to a periodic impairment review for other-than-temporary declines in fair value. The Company’s review includes the consideration of the cause of the impairment including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in the market value. When the Company determines that the decline in fair value of an investment is below its accounting basis and this decline is other than temporary, it reduces the carrying value of the security it holds and records a loss in the amount of such decline. Fair Value of Financial Instruments The Company measures and reports its cash equivalents, investments and financial liabilities at fair value. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three Level I—Unadjusted quoted prices in active markets for identical assets or liabilities; Level II—Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not Level III—Unobservable inputs that are supported by little or no The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. Segment Information The Company operates in a single segment, the development and commercialization of innovative therapies for use in medically supervised settings. The Company’s product sales revenue consists of sales of DSUVIA in the United States, DZUVEO in Europe by Aguettant, and, through May 2021, 8, Concentration of Risk The Company invests cash that is currently not $250,000. The Company relies on a single third third DSUVIA sales are concentrated with the DoD and with a limited number of wholesalers in the United States. Zalviso was sold in Europe by Grünenthal through May 2021. July 2021, Revenue and accounts receivable have been concentrated with these customers. Revenues from customers that accounted for 10% December 31, 2022 2021 Year Ended December 31, Percent of Total Revenue 2022 2021 Aguettant 10 % 62 % Grünenthal 0 % 12 % Wholesaler A 25 % 16 % Wholesaler B 12 % 8 % Distributor A 28 % 5 % Distributor B 12 % 2 % Accounts Receivable, Net The need for a bad debt allowance is evaluated each reporting period based on the Company’s assessment of the creditworthiness of its customers or any other potential circumstances that could result in bad debt. The Company believes that the entire accounts receivable balance as of December 31, 2022 no December 31, 2022 2021. Accounts receivable, net from customers that accounted for 10% December 31, 2022 2021 As of December 31, Percent of Accounts Receivable, Net 2022 2021 Customer A 58 % 0 % Customer B 19 % 73 % Customer C 15 % 9 % Inventories, Net Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first first third The Company's policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or net realizable value approach as that used to value the inventory. Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally three five not Impairment of Long-Lived Assets The Company periodically assesses the impairment of long-lived assets and, if indicators of asset impairment exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through an analysis of the undiscounted future expected operating cash flows. If impairment is indicated, the Company records the amount of such impairment for the excess of the carrying value of the asset over its estimated fair value. See Note 5, Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether or not first not, not Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not not no may not Leases The Company follows the provisions of Accounting Standards Update, or ASU, 2016 02, Leases (Topic 842 not may Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the consolidated balance sheets as operating lease right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. Revenue from Contracts with Customers The Company follows the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Product Sales Revenue The Company sells its product primarily through distributors. Revenues from product sales are recognized when distributors obtain control of the Company’s product, which occurs at a point in time, upon delivery to such distributors. These distributors subsequently resell the product to certified medically supervised healthcare settings. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and other certified medically supervised healthcare settings that provide for privately negotiated discounts with respect to the purchase of its products. For revenue recognition under bill-and-hold arrangements, wherein the customer agrees to buy product from the Company but requests delivery at a later date, the Company deems that control passes to the customer when the product is ready for delivery. The Company recognizes revenue under these types of arrangements when a signed agreement is in place, the transaction is billable, the customer has significant risk and rewards for the product and the ability to direct the asset, the product has been set aside specifically for the customer, and the product cannot be redirected to another customer. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, government rebates, returns, distribution fees, GPO fees and product returns. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. The amount of variable consideration that is included in the transaction price may not 606 may Chargebacks not Government Rebates Returns 6 12 may Distribution Fees GPO Fees Trade Discounts and Allowances The Company believes its estimated allowances for chargebacks, government rebates and product returns require a high degree of judgment and are subject to change based on its limited experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distribution fees, GPO fees and trade discounts and allowances do not Contract and Other Collaboration Revenue The Company generates revenue from collaboration agreements. These agreements typically include payments for upfront signing or license fees, cost reimbursements for development and manufacturing services, milestone payments, product sales, and royalties on licensee’s future product sales. Product sales related revenue under these collaboration agreements is classified as product sales revenue, while other revenue generated from collaboration agreements is classified as contract and other collaboration revenue. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price The Company has both fixed and variable consideration. Variable consideration for product revenue is described as Net product sales in the consolidated statements of operations. For collaboration agreements, non-refundable upfront fees and product supply selling prices are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not not not For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights and material rights for discounts on manufacturing services are calculated using an income approach model and can include the following key assumptions: the development timeline, sales forecasts, costs of product sales, commercialization expenses, discount rate, the time which the manufacturing services are expected to be performed, and probabilities of technical and regulatory success. For all other performance obligations, the Company uses a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under collaboration arrangements and the period over which the Company expects to complete its performance obligations under the arrangement. The Company estimates the performance period or measure of progress at the inception of the arrangement and re-evaluates it each reporting period. This re-evaluation may Cost of Goods Sold Cost of goods sold for product revenue includes third Under the Grünenthal Agreements, the Company sold Zalviso to Grünenthal at predetermined, contractual transfer prices that were less than the direct costs of manufacturing and recognized indirect costs as period costs where they were in excess of normal capacity and not third Research and Development Expenses Research and development costs are charged to expense when incurred. Research and development expenses include salaries, employee benefits, including stock-based compensation, consultant fees, laboratory supplies, costs associated with clinical trials and manufacturing, including contract research organization fees, other professional services and allocations of corporate costs. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. Stock-Based Compensation Compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2020 2020 2011 2011 2011 The Black-Scholes option pricing model requires inputs such as expected term, expected volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the stock‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical stock price performance over the expected term of the option, which are adjusted as necessary for any other factors which may not Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480 10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity 815 40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company s Own Stock 480 10, not 480 10, 815 40 815 40, may not 815 40, 815 40 no Restructuring Costs The Company’s restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. In May 2022, December 31, 2022, second 2022. No Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties In September 2015, November 13, 2020. May 2021 May 2021. Under the Royalty Monetization, the Company had a continuing obligation to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization was 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 was 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, was to be amortized as interest expense over the life of the liability. Consequently, the Company imputed interest on the unamortized portion of the liability and recorded interest expense, or interest income, as these estimates were updated and recorded non-cash royalty revenues and non-cash interest income (expense), net, within its consolidated statements of operations over the term of the Royalty Monetization. When the expected payments under the Royalty Monetization were lower than the gross proceeds of $65.0 million received, the Company deferred recognition of any probable contingent gain until the Royalty Monetization liability expired. See Note 11, Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive income (loss) and is disclosed in the consolidated statements of operations. For the Company, other comprehensive income (loss) consists of changes in unrealized gains and losses on the Company’s investments. Income Taxes Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. Net Income (Loss) per Share of Common Stock Basic and diluted net income (loss) per common share, or EPS, are calculated in accordance with the provisions of Financial Accounting Standards Board, or FASB, ASC Topic 260, Earnings per Share The Company applies the two two may may no two no not November 2021 2022 12, 14, For additional information regarding the net income (loss) per share, see Note 16, Recently Adopted Accounting Pronouncements In May 2021, 2021 04, Earnings Per Share (Topic 260 470 50 718 s Own Equity (Subtopic 815 40 s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force) 2021 14, not 2021 04 2021 04 December 15, 2021, 2021 04 2021 04. The Company adopted ASU 2021 04 January 1, 2022, 12, 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. not |
Note 2 - Investments and Fair V
Note 2 - Investments and Fair Value Measurement | 12 Months Ended |
Dec. 31, 2022 | |
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 tables below summarize the Company’s cash, cash equivalents and investments (in thousands): As of December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash, cash equivalents and restricted cash: Cash $ 13,275 $ — $ — $ 13,275 Money market funds 321 — — 321 U.S. government agency securities 2,444 — — 2,444 Commercial paper 4,235 — — 4,235 Total cash, cash equivalents and restricted cash 20,275 — — 20,275 Short-term investments: Commercial paper 495 — — 495 Total short-term investments 495 — — 495 Total cash, cash equivalents, restricted cash and short-term investments $ 20,770 $ — $ — $ 20,770 As of December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash, cash equivalents and restricted cash: Cash $ 1,443 $ — $ — $ 1,443 Money market funds 2,822 — — 2,822 Commercial paper 8,398 — — 8,398 Total cash, cash equivalents and restricted cash 12,663 — — 12,663 Short-term investments: Commercial paper 29,504 — — 29,504 Corporate debt securities 9,463 — — 9,463 Total short-term investments 38,967 — — 38,967 Total cash, cash equivalents, restricted cash and short-term investments $ 51,630 $ — $ — $ 51,630 None December 31, 2022 2021. December 31, 2022 2021. No December 31, 2022 2021. As of December 31, 2022 2021, one Fair Value Measurement The Company’s financial instruments consist of Level I and II assets. Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 third December 31, 2022, 2022 12, 820 The following tables set forth the fair value of the Company’s financial assets by level within the fair value hierarchy (in thousands): As of December 31, 2022 Fair Value Level I Level II Level III Assets Money market funds $ 321 $ 321 $ — $ — U.S. government agency securities 2,444 — 2,444 — Commercial paper 4,730 — 4,730 — Total assets measured at fair value 7,495 321 7,174 Liabilities Warrant liability 7,098 — — 7,098 Total liabilities measured at fair value 7,098 — — $ 7,098 As of December 31, 2021 Fair Value Level I Level II Level III Assets Money market funds $ 2,822 $ 2,822 $ — $ — Commercial paper 37,902 — 37,902 — Corporate debt securities 9,463 — 9,463 — Total assets measured at fair value $ 50,187 $ 2,822 $ 47,365 $ — |
Note 3 - Inventories, Net
Note 3 - Inventories, Net | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 3. Inventories consist of finished goods, raw materials and work in process and are stated at the lower of cost or net realizable value and consist of the following (in thousands): As of December 31, 2022 2021 Raw materials $ 796 $ 722 Work in process 338 159 Finished goods 44 230 Inventories $ 1,178 $ 1,111 The Company did not December 31, 2022. December 31, 2021, may |
Note 4 - Asset Acquisition
Note 4 - Asset Acquisition | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Business Combination Disclosure [Text Block] | 4. On January 7, 2022, five January 7, 2022, The shares issued in the merger were issued in a private placement pursuant to the exemption from registration under Section 4 2 1933, 506 not The merger has been accounted for as an asset acquisition of a single IPR&D asset that has an alternative future use. The initial measurement of the asset purchased of $8.8 million was based on the purchase cost of $12.4 million including (i) $6.0 million common stock fair value on the closing date (issued and held back on the acquisition date), (ii) $0.5 million seller’s costs paid by the Company, (iii) $3.5 million cash and (iv) approximately $2.5 million of transaction costs less purchase price allocated to cash acquired of $3.5 million. Due to the nature of regulatory and sales-based milestones, the contingent consideration of up to $26.0 million was not not December 31, 2022, none The following table summarizes the total consideration for the acquisition and the value of the IPR&D asset acquired (in thousands): Consideration Cash $ 3,536 Issuance of common stock to Lowell security holders in connection with asset acquisition 5,161 Issuance of common stock to settle Lowell’s transaction costs in connection with asset acquisition 350 Liability for issuance of 69,808 hold back shares to Lowell securityholders (1) 800 Transaction costs 2,521 Total consideration $ 12,368 IPR&D Asset Acquired Purchase price $ 12,368 Cash acquired (3,549 ) Total IPR&D asset acquired (2) $ 8,819 ( 1 ( 2 The IPR&D asset will be initially accounted for as an indefinite-lived asset, and as a long-lived asset, it will be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not December 31, 2022. |
Note 5 - Property and Equipment
Note 5 - Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Property, Plant and Equipment Disclosure [Text Block] | 5. Property and equipment, net consist of the following (in thousands): Balance as of December 31, 2022 December 31, 2021 Laboratory equipment $ 4,396 $ 4,406 Leasehold improvements 5,838 5,838 Computer equipment and software 1,565 1,589 Construction in process 8,979 13,805 Tooling 826 826 Furniture and fixtures 250 250 21,854 26,714 Less accumulated depreciation and amortization (11,593 ) (10,786 ) Property and equipment, net $ 10,261 $ 15,928 The Company decided to realign its cost structure from a focus on commercialization to a focus on advancing its recently acquired late-stage development pipeline, namely the pre-filled syringes and Niyad product candidates. As a result, the Company decided to not not July 2022, not no December 31, 2022. $1.1 December 31, 2022 2021, |
Note 6 - In-license Agreement
Note 6 - In-license Agreement | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
In-license Agreement [Text Block] | 6. On July 14, 2021, 10 3 10 50 The PFS Agreement has an initial term of ten 10 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 12 The Company has the right to grant sublicenses to its affiliates or, with the prior approval of Aguettant, third As of December 31, 2022, no See Note 20, |
Note 7 - Out-license Agreements
Note 7 - Out-license Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Out-license Agreement [Text Block] | 7. DZUVEO On July 14, 2021, The DZUVEO Agreement has an initial term of ten 10 first December 31 December 31, 2022, January 1, 2022 April 30, 2022). five not six 6 may not The Company is entitled to receive up to €47.0 €2.5 third 2021, third 2021. Beginning in the third third The DZUVEO Agreement also provides Aguettant with a right of first eighteen 18 See Note 20, Zalviso On May 18, 2020, November 13, 2020. May 12, 2021 May 12, 2021. July 2022, |
Note 8 - Revenue from Contracts
Note 8 - Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 8 Revenue from Contracts with Customers The following table summarizes revenue from contracts with customers for the years ended December 31, 2022 2021 December 31, 2022 2021 Product sales: DSUVIA $ 1,588 $ 735 DZUVEO 183 — Zalviso — 270 Total product sales 1,771 1,005 Contract and collaboration revenue: License revenue — 1,696 Non-cash royalty revenue related to Royalty Monetization (Note 11) — 83 Royalty revenue — 28 Other revenue — 6 Total revenues from contract and other collaboration — 1,813 Total revenue $ 1,771 $ 2,818 For additional detail on the Company’s accounting policy regarding revenue recognition, refer to Note 1, Product Sales The Company’s commercial launch of DSUVIA in the United States occurred in the first 2019. 20, Zalviso was sold in Europe by the Company’s collaboration partner, Grünenthal, through May 12, 2021, July 2022, 20, 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 and license revenue recognized under the DZUVEO Agreement. For the year ended December 31, 2022, not The Company concluded that Aguettant is a customer and therefore revenue recognition for the DZUVEO Agreement in Europe should be accounted for in accordance with ASC Topic 606, Revenue from Contracts with Customers The Company identified the following promises under the DZUVEO Agreement at inception, namely: (a) granting of the licenses, (b) manufacturing services inclusive of quality control testing and stability testing which are options in the initial arrangement, and (c) a material right associated with the discounted price for future optional orders of DZUVEO commercial product supply. The licenses are considered to be functional intellectual property. The Company determined that the licenses are capable of being distinct because Aguettant can benefit from the license on its own by commercializing the underlying product using its own resources. The Company manufacturing services are not third no not The Company evaluated if there is an interdependence between the performance obligations and determined that the licenses are a combined solution and the predominant performance obligation. The material right is separately identifiable in the context of the contract and is not not not The transaction price at the inception of the DZUVEO Agreement consisted of the upfront fee of €2.5 December 31, 2022 no The Company determined that the $52.2 million not The transaction price is allocated to the performance obligations based on relative standalone selling price which were determined for the licenses using the adjusted market approach, and for the manufacturing services and the material right associated with discounted DZUVEO product supply using the cost-plus reasonable margin approach. Variable consideration is allocated to the specific performance obligations to which it relates. For revenue recognition purposes, the Company determined that the duration of the contract began on the effective date in July 2021 10 five Revenue for the granting of the licenses was recognized on the effective date of the DZUVEO Agreement at the point in time that the licenses are effective. The manufacturing services inclusive of quality control testing and stability testing will be recognized at a point in time when, or as, the Company transfers the associated promised goods and services to Aguettant. The material right for the discounted price per unit on future optional orders will be recognized over time with the measure of progress being straight-line over the period in which the Company stands ready to provide the discounted price per unit on the manufacturing services. No contract and other collaboration revenue was recorded related to the DZUVEO Agreement for the year ended December 31, 2022. December 31, 2021, See Note 20, Contract Liabilities A contract liability of $1.2 million was recorded on the consolidated balance sheets as deferred revenue as of December 31, 2022, not no December 31, 2022 As of December 31, 2022, December 31, 2022 2021 $0.3 The following table presents changes in the Company’s contract liability for the years ended December 31, 2022 2021 Balance at January 1, 2021 $ 49 Additions (1) 1,237 Deductions for performance obligations satisfied: In current period (49 ) Balance at December 31, 2021 $ 1,237 Deductions for performance obligations satisfied: In current period (86 ) Balance at December 31, 2022 $ 1,151 ( 1 See Note 20, |
Note 9 - Long-term Debt
Note 9 - Long-term Debt | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Long-Term Debt [Text Block] | 9. Loan Agreement with Oxford On May 30, 2019, May 30, 2019. The interest rate is calculated at a rate equal to the sum of (a) the greater of (i) the 30 The Wall Street Journal July 1, 2020 June 1, 2023. The Company may The Loan Agreement includes customary representations and covenants that, subject to exceptions, will restrict the Company’s ability to do the following things: declare dividends or redeem or repurchase equity interests; incur additional liens; make loans and investments; incur additional indebtedness; engage in mergers, acquisitions, and asset sales; transact with affiliates; undergo a change in control; add or change business locations; and engage in businesses that are not not The Loan Agreement also includes standard events of default, including payment defaults, breaches of covenants following any applicable cure period, a material impairment in the perfection or priority of the Lender’s security interest or in the value of the collateral, a material adverse change in business, operations or the prospect of repayment, events relating to bankruptcy or insolvency. The Loan also contains a cross default provision, under which if a third may may December 31, 2022, In connection with the Loan Agreement, on May 30, 2019, 12, The outstanding balance due under the Loan Agreement was $5.4 million and $13.3 million at December 31, 2022 2021, December 31, 2022 2021, December 31, 2022 2021, Non-Interest Bearing Payments for the Construction of Leasehold Improvements In August 2019, may four December 31, 2022 2021, December 31, 2022 2021 20, Future Payments on Long-Term Debt The following table summarizes the outstanding future payments associated with the Company’s long-term debt as of December 31, 2022 2023 $ 5,951 Total payments 5,951 Less amount representing interest (134 ) Notes payable, gross 5,817 Less: Unamortized portion of EOT Fee (26 ) Less: Unamortized discount on notes payable (28 ) Long-term debt 5,763 Less current portion (5,763 ) Long-term debt, net of current portion $ — |
Note 10 - Leases
Note 10 - Leases | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Lessee, Operating Leases [Text Block] | 10. Office Lease The Company leased office and laboratory space for its former corporate headquarters, located at 301 351 On March 26, 2021, April 30, 2021. December 31, 2021. April 30, 2021, December 31, 2021. On March 26, 2021, 25821 April 1, 2021. two three one Contract Manufacturing Leases On December 12, 2012, December 31, 2017, two eighteen 2013, On November 29, 2022, May 31, 2024. 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. 20, The components of lease expense are presented in the following table (in thousands): Year ended December 31, 2022 Year ended December 31, 2021 Operating lease costs $ 1,373 $ 1,467 Gain on derecognition of operating lease — (522 ) Sublease income — (199 ) Loss on termination of sublease — 331 Net lease costs $ 1,373 $ 1,077 The weighted average remaining lease term and discount rate related to the operating leases are presented in the following table: December 31, December 31, 2022 2021 Weighted-average remaining lease term – operating leases (in years) 4.1 5.0 Weighted-average remaining discount rate – operating leases 12.8 % 12.8 % Maturities of lease liabilities as of December 31, 2022 Year: 2023 $ 2,127 2024 1,090 2025 1,040 2026 1,040 2027 415 Thereafter — Total future minimum lease payments 5,712 Less imputed interest (1,052 ) Total $ 4,660 Reported as: Operating lease liabilities $ 4,660 Operating lease liabilities, current portion (1,701 ) Operating lease liabilities, net of current portion $ 2,959 |
Note 11 - Liability Related to
Note 11 - Liability Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Liability Related To Sale Of Future Royalties Disclosure [Text Block] | 11. On September 18, 2015, first four 80% $195.0 The Company periodically assessed the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments were greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company prospectively adjusted the amortization of the liability and the effective interest rate. Grünenthal notified the Company that it was terminating the Amended License Agreement effective November 13, 2020. August 31, 2020, May 12, 2021 May 12, 2021. On May 31, 2022, May 31, 2022, no The effective interest income rate for the years ended December 31, 2022 2021 The following table shows the activity within the liability account during the year ended December 31, 2022 ( Year ended December 31, 2022 Period from inception to December 31, 2022 Liability related to sale of future royalties — beginning balance $ 85,288 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue — (1,083 ) Non-cash interest (income) expense recognized (1,136 ) 24,051 Consideration paid for termination of Royalty Monetization (100 ) (100 ) Gain on termination of liability related to sale of future royalties (84,052 ) (84,052 ) Liability related to sale of future royalties as of December 31, 2022 $ — $ — As mentioned above, the Royalty Monetization was terminated on May 31, 2022. |
Note 12 - Warrants
Note 12 - Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Warrants Disclosure [Text Block] | 12. December 2022 On December 27, 2022, 14, 2022 2022 December 2022 The 2022 December 29, 2022, 2022 six six 2022 2022 2022 2022 December 2022 The 2022 In the event of certain fundamental transactions involving the Company, the holder of the 2022 may 2022 not 2022 2022 2022 not 2022 not December 2022 two 2022 December 31, 2022 2022 no As of December 31, 2022, August 2022 LPC Warrant On August 3, 2022, 14, November 2022, The August 2022 February 3, 2028. August 2022 August 2022 August 3, 2023, August 2022 August 2022 In December 2022, December 2022 no 2022 The August 2022 August 2022 August 2022 two August 2022 As of December 31, 2022, August 2022 not November 2021 On November 15, 2021, 14, November 2021 no The November 2021 6 five November 15, 2026. November 15, 2021. The November 2021 five 815, two Upon the closing of the December 2022 November 2021 December 29, 2028. November 2021 December 2022 November 2021 November 2021 December 2022 2021 04, November 2021 2022 November 2021 December 29, 2022 The remaining warrants issued in the November 17, 2021 December 31, 2022, November 15, 2026. Loan Agreement Warrants In connection with the Loan Agreement, on May 30, 2019, may ten The Company estimated the fair value of these Loan Agreement Warrants as of the issuance date to be $0.4 million, which was used in estimating the fair value of the debt instrument and was recorded as equity. The fair value of the Loan Agreement Warrants was calculated using the Black-Scholes option-valuation model, and was based on the strike price of $56.60, the stock price at issuance of $53.20, the ten As of December 31, 2022, not May 2029. |
Note 13 - Commitments and Conti
Note 13 - Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Commitments and Contingencies Disclosure [Text Block] | 13. Litigation On June 8, 2021, two 10 20 10b 5 December 16, 2021, March 7, 2022. three 10 20 10b 5 20A September 1, 2022, July 21, 2022. September 28, 2022, November 28, 2022, second three 10 20 January 30, 2023, second March 16, 2023, second April 17, 2023 second On July 6, 2021, ten September 30, 2021, October 26, 2021, November 17, 2021, three nine four December 6, 2021, four 1A. may . 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 14 - Stockholders' Equity
Note 14 - Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Stockholders' Equity Note Disclosure [Text Block] | 14. Equity (Deficit) Reverse Stock Split On September 23, 2022, 1 10 1 1 5:01 October 25, 2022. October 26, 2022. Preferred Stock On August 3, 2022, December 29, 2022 August 2022 12, The Series A Redeemable Convertible Preferred Stock was convertible, at the option of the holders, into shares of common stock at a conversion price of approximately $3.70 per share, subject to adjustment and beneficial ownership limitations set forth in the Certificate of Designation. The Company had the option to redeem the Series A Redeemable Convertible Preferred Stock for cash at 105% of the Stated Value on the date of and for 15 110% not December 31, 2022, The holders of the Series A Redeemable Convertible Preferred Stock were entitled to certain registration rights, rights for approval of increases in the authorized shares of such series, and to dividends paid on common stock on an as-if converted basis. The Series A Redeemable Convertible Preferred stock had no 110% On October 11, 2022, October 12, 2022, no October 25, 2022, Common Stock 2022 On December 29, 2022, December 2022 2022 2022 2022 12, 2022 2022 2022 2022 2022 2022 2022 12, 2021 On January 22, 2021, January 27, 2021, 2021 On November 17, 2021, 12, November 2021 November 15, 2021. 815, two ATM Agreement On June 21, 2016, SM may May 9, 2019, may The Company issued and sold approximately 0.1 million shares of common stock pursuant to the ATM Agreement and received net proceeds of $0.5 million, after deducting fees and expenses, during the year ended December 31, 2022. December 31, 2021, As of December 31, 2022, Stock Plans 2011 In January 2011, 2011 2011 2011 2011 January 1 January 1, 2012 January 1, 2020, December 31 As of June 16, 2020, may 2011 2011 2011 2011 Amended 2020 On June 16, 2020, 2020 2020 2020 The initial aggregate number of shares of the Company’s common stock issuable pursuant to stock awards under the 2020 2011 not 2020 not 10 not On June 17, 2021, 2021 2020 2020 2020 may 2020 not 0.2 2020 2020 2011 may 2020 2020 Amended and Restated 2011 Additionally, on June 16, 2020, 2011 2011 In the year ended December 31, 2022, 2022 2021 December 31, 2022, |
Note 15 - Stock-based Compensat
Note 15 - Stock-based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 15. The Company recorded total stock-based compensation expense for stock options, stock awards and the Amended ESPP as follows (in thousands): December 31, 2022 December 31, 2021 Cost of goods sold $ 62 $ 92 Research and development 570 813 Selling, general and administrative 2,257 3,704 Total $ 2,889 $ 4,609 The following table summarizes restricted stock unit activity under the Company’s Equity Incentive Plans: Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2021 69,890 $ 35.75 Granted 57,448 33.65 Vested (29,338 ) 37.75 Forfeited (9,289 ) 31.56 Restricted stock units outstanding, December 31, 2021 88,711 $ 34.16 Granted 58,502 7.75 Vested (44,744 ) 35.46 Forfeited (19,691 ) 25.00 Restricted stock units outstanding, December 31, 2022 82,778 $ 16.97 The following table summarizes stock option activity under the Company’s Equity Incentive Plans: Number of Stock Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (in thousands) December 31, 2021 714,085 $ 59.79 Granted 117,022 7.75 Forfeited (35,645 ) 26.46 Expired (69,839 ) 60.42 Exercised — — December 31, 2022 725,623 $ 52.98 5.3 $ — Vested and exercisable options—December 31, 2022 515,933 $ 65.76 3.9 $ — Vested and expected to vest—December 31, 2022 725,623 $ 52.80 5.3 $ — As of December 31, 2022, 2020 Additional information regarding the Company’s stock options outstanding and vested and exercisable as of December 31, 2022 Options Outstanding Options Vested and Exercisable Exercise Prices Number of Stock Options Outstanding Weighted-Average Remaining Contractual Life (Years) Weighted-Average Exercise Price per Share Shares Subject to Stock Options Weighted-Average Exercise Price per Share $4.62 - $8.03 88,096 9.2 $ 7.54 — $ — $8.36 - $12.54 19,046 9.1 $ 8.43 — $ — $14.40 - $21.60 20,941 6.9 $ 16.93 13,643 $ 16.84 $22.40 - $33.60 11,700 8.1 $ 28.62 10,774 $ 28.58 $34.40 - $51.60 311,695 6.0 $ 41.16 217,425 $ 42.75 $52.00 - $78.00 168,275 3.5 $ 62.66 168,221 $ 62.66 $78.40 - $117.60 62,756 1.0 $ 97.95 62,756 $ 97.95 $132.00 - $198.00 20,520 1.6 $ 133.16 20,520 $ 133.16 $204.40 - $306.60 22,594 1.0 $ 206.96 22,594 $ 206.96 725,623 5.3 $ 52.98 515,933 $ 65.76 The weighted average grant-date fair value of options granted during the years ended December 31, 2022 2021 December 31, 2022, December 31, 2022 2021 December 31, 2021 2020 On March 3, 2021, 2020 December 31, 2022 2021. The Company uses the Monte Carlo Simulation model to evaluate the derived service period and fair value of awards with market conditions, including assumptions of historical volatility and risk-free interest rate commensurate with the vesting term. The Company used the following assumptions to calculate the fair value of each performance-based stock option: Year Ended December 31, 2022 2021 Derived service period (in years) — 2.3 – 2.6 Risk-free interest rate — 1.5% Expected volatility — 90% Expected dividend rate — 0% The Company used the following assumptions to calculate the fair value of each time-based stock option: Year Ended December 31, 2022 2021 Expected term (in years) 6.3 6.0 – 6.2 Risk-free interest rate 1.6% - 3.0% 0.9% - 1.3% Expected volatility 88% 90% Expected dividend rate 0% 0% |
Note 16 - Net Loss Per Share of
Note 16 - Net Loss Per Share of Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 16. The Company applies the two 1 2 two 2022, two not December 31, 2021 no December 2022 The following table sets forth the computation of the Company’s basic and diluted net income (loss) per share of common stock during the years ended December 31, 2022 2021 Year ended December 31, 2022 2021 (in thousands, except share and per share amounts) Basic net income (loss) per common share: Net income (loss) $ 47,755 $ (35,099 ) Less: deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — Less: income allocated to participating securities (5,240 ) — Net income (loss) attributable to common shareholders $ 42,329 $ (35,099 ) Weighted average shares outstanding — basic 7,385,348 5,993,013 Net income (loss) — basic $ 5.73 $ (5.86 ) Year ended December 31, 2022 2021 (in thousands, except share and per share amounts) Diluted net income (loss) per common share: Net income (loss) $ 47,755 $ (35,099 ) Less: deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — Less: income allocated to participating securities (5,227 ) — Net income (loss) attributable to common shareholders $ 42,342 $ (35,099 ) Weighted average shares outstanding — basic 7,385,348 5,993,013 Dilutive effect of warrants 20,285 — Dilutive effect of RSUs 1,353 — Weighted average shares outstanding — diluted 7,406,986 5,993,013 Net income (loss) — diluted $ 5.72 $ (5.86 ) The following outstanding shares of common stock equivalents were excluded from the computation of diluted net income (loss) per share of common stock for the periods presented because including them would have been antidilutive: Year Ended December 31, 2022 2021 ESPP, RSUs and stock options to purchase common stock 815,710 816,421 Common stock warrants 133,833 883,833 In addition, the shares held back and contingently issuable in connection with the Lowell Merger, as described in Note 4 not |
Note 17 - Accrued Liabilities
Note 17 - Accrued Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Accounts Payable and Accrued Liabilities Disclosure [Text Block] | 17. Accrued liabilities consist of the following (in thousands): December 31, 2022 2021 Accrued compensation and employee benefits $ 1,944 $ 2,974 Accrued professional services 625 1,523 Accrued product returns and sales allowances 315 775 Deferred revenue 115 86 Other accrued liabilities 1,267 1,166 Total accrued liabilities $ 4,266 $ 6,524 |
Note 18 - 401(k) Plan
Note 18 - 401(k) Plan | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Retirement Benefits [Text Block] | 18. 401 The Company sponsors a 401 401 401 December 31, 2022 2021, |
Note 19 - Income Taxes
Note 19 - Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 19. The Company recorded a provision for income taxes of $13 thousand and $5 thousand for the years ended December 31, 2022 2021, Net deferred tax assets as of December 31, 2022 2021 December 31, 2022 December 31, 2021 Deferred tax assets: Accruals and other $ 1,738 $ 3,989 Research credits 7,392 7,275 Net operating loss carryforward 84,325 75,452 Section 59(e) R&D expenditures 3,496 5,070 Section 174 R&D expenditures 981 — Deferred revenue — 19,666 Total deferred tax assets 97,932 111,452 Valuation allowance (97,932 ) (111,452 ) Net deferred tax assets $ — $ — Reconciliations of the statutory federal income tax to the Company’s effective tax during the years ended December 31, 2022 2021 Year Ended December 31, 2022 2021 Tax at statutory federal rate $ 10,031 $ (7,370 ) State tax—net of federal benefit 823 231 Acquired assets 1,728 — Stock options 611 718 Other 340 (20 ) Change in valuation allowance (13,520 ) 6,446 Provision for income taxes $ 13 $ 5 ASC 740 not.” December 31, 2022 2021, As of December 31, 2022, January 1, 2018 2029. 2018 2022 80% December 31, 2022, 2028. As of December 31, 2022, 2026. December 31, 2022, Under Sections 382 383 1986, 50% three may December 31, 2013, two first 2006 second July 2013 not Uncertain Tax Positions A reconciliation of the beginning and ending balances of the unrecognized tax benefits during the years ended December 31, 2022 2021 Year Ended December 31, 2022 2021 Unrecognized benefit—beginning of period $ 2,635 $ 2,635 Gross increases—prior period tax positions — — Gross increases—current period tax positions 43 — Unrecognized benefit—end of period $ 2,678 $ 2,635 The entire amount of the unrecognized tax benefits would not There were no accrued interest or penalties related to unrecognized tax benefits in the years ended December 31, 2022 2021. 2005 2014, 2016 2022, not not 12 In March 2020, not December 31, 2021 2022. December 31, 2021. December 31, 2022. |
Note 20 - Subsequent Events
Note 20 - Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 20. Asset Purchase Agreement On March 12, 2023, 30 15 third third The Purchase Agreement contains customary representations, warranties, and covenants by each party. Buyer agreed not six July 1, 2023, The Closing is subject to customary conditions (including, the accuracy of representations and warranties, performance of covenants, and no Amendments to Certain Agreements Between AcelRx and Aguettant AcelRx and Aguettant are parties to (a) the License and Commercialization Agreement, dated July 14, 2021, December 6, 2021, Pursuant to the Amended DZUVEO Agreement, upon execution thereof, (a) Aguettant’s obligations to make sales-based milestone payments and to achieve certain levels of minimum sales will terminate, (b) before Aguettant has established a semi-automated packaging line for Product, AcelRx will manufacture and supply DZUVEO in the form of bulk products ( i.e. i.e. not Pursuant to the Purchase Agreement, AcelRx will assign the Amended DZUVEO Agreement and the Amended and Restated Supply Agreement to Buyer at the Closing. In addition, AcelRx and Aguettant are parties to the License and Commercialization Agreement, dated July 14, 2021, April 1, 2023, ( Termination Agreement and Mutual Release Between AcelRx and Catalent On March 12, 2023, August 15, 2019 September 24, 2020, March 31, 2021, 2022 The 2022 first 2023. |
Note 21 - Restatement (Unaudite
Note 21 - Restatement (Unaudited) | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
Error Correction [Text Block] | 21. Restatement of Previously Issued Unaudited Interim Condensed Consolidated Financial Statements In connection with the Company’s year-end financial statement close and preparation of its Annual Report on Form 10 December 31, 2022, three six June 30, 2022 nine September 30, 2022 ( not two November 2021 December 31, 2021 three March 31, 2022, not two not November 2021. The error has no no On March 30, 2023, no The following tables present the impact of the error on basic and diluted EPS for the three six June 30, 2022, nine September 30, 2022 ( 1 20 Three Months Ended June 30, 2022 As Previously Reported Adjustment As Restated Basic net income per common share: Net income $ 70,663 $ — $ 70,663 Income allocated to participating securities — (7,511 ) (7,511 ) Net income attributable to Common Shareholders, basic $ 70,663 $ (7,511 ) $ 63,152 Net income attributable to Common Shareholders per share, basic $ 9.60 $ (1.02 ) $ 8.58 Shares used in computing net income attributable to Common Shareholders per share, basic 7,356,952 — 7,356,952 Diluted net income (loss) per common share: Net income $ 70,663 $ — $ 70,663 Income allocated to participating securities — (7,508 ) (7,508 ) Net income attributable to Common Shareholders, diluted $ 70,663 $ (7,508 ) $ 63,155 Net income attributable to Common Shareholders per share, diluted $ 9.60 $ (1.02 ) $ 8.58 Shares used in computing net income attributable to Common Shareholders per share, diluted 7,360,453 — 7,360,453 Six Months Ended June 30, 2022 As Previously Reported Adjustment As Restated Basic net income per common share: Net income $ 61,989 $ — $ 61,989 Income allocated to participating securities — (6,619 ) (6,619 ) Net income attributable to Common Shareholders, basic $ 61,989 $ (6,619 ) $ 55,370 Net income attributable to Common Shareholders per share, basic $ 8.47 $ (0.91 ) $ 7.56 Shares used in computing net income attributable to Common Shareholders per share, basic 7,319,279 — 7,319,279 Diluted net income per common share: Net income $ 61,989 $ — $ 61,989 Income allocated to participating securities — (6,618 ) (6,618 ) Net income attributable to Common Shareholders, diluted $ 61,989 $ (6,618 ) $ 55,371 Net income attributable to Common Shareholders per share, diluted $ 8.47 $ (0.91 ) $ 7.56 Shares used in computing net income attributable to Common Shareholders per share, diluted 7,321,022 — 7,321,022 Nine Months Ended September 30, 2022 As Previously Reported Adjustment As Restated Basic net income per common share: Net income $ 55,239 $ — $ 55,239 Deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — (186 ) Income allocated to participating securities (129 ) (5,851 ) (5,980 ) Net income attributable to Common Shareholders, basic $ 54,924 $ (5,851 ) $ 49,073 Net income attributable to Common Shareholders per share, basic $ 7.48 $ (0.79 ) $ 6.69 Shares used in computing net income attributable to Common Shareholders per share, basic 7,338,853 — 7,338,853 Diluted net income per common share: Net income $ 55,239 $ — $ 55,239 Deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — (186 ) Income allocated to participating securities (129 ) (5,846 ) (5,975 ) Net income attributable to Common Shareholders, diluted $ 54,924 $ (5,846 ) $ 49,078 Net income attributable to Common Shareholders per share, diluted $ 7.46 $ (0.78 ) $ 6.68 Shares used in computing net income attributable to Common Shareholders per share, diluted 7,367,293 (21,339 ) 7,345,954 |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2022 | |
Notes to Financial Statements | |
SEC Schedule, 12-09, Schedule of Valuation and Qualifying Accounts Disclosure [Text Block] | SCHEDULE II: VALUATION AND QUALIFYING ACCOUNTS (in thousands) Additions Balance at Charged as a Balance at Beginning of Reduction to End of Description Period Revenue Deductions* Period Sales & return allowances, discounts, chargebacks and rebates: Year ended December 31, 2022 $ 780 $ 521 $ (977 ) $ 324 Year ended December 31, 2021 $ 668 $ 1,012 $ (900 ) $ 780 * Deductions to sales discounts and allowances relate to discounts or allowances actually taken or paid. |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
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 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, May 12, 2021 ( Termination of Gr nenthal Agreements July 2022, On March 12, 2023, 30 20, In July 2021, 20, In July 2021, 10 3 10 50 20, On January 7, 2022, 4, 10 not 8 608, Termination of Gr nenthal Agreements On December 16, 2013, July 17, 2015, September 20, 2016, September 2015, December 16, 2013, July 15, 2015, On May 18, 2020, November 13, 2020. May 12, 2021 May 12, 2021. July 2022, Termination of Royalty Monetization On September 18, 2015, August 31, 2020, May 31, 2022, May 31, 2022, no Liquidity and Going Concern The consolidated financial statements for the year ended December 31, 2022 December 31, 2022; twelve 12 10 may SM third not may not not may third may may not |
Reverse Stock Split, Policy [Policy Text Block] | Reverse Stock Split On September 23, 2022, 1 1 1 20, October 25, 2022, one not As the par value per share of the Company's common stock remained unchanged at $0.001 per share, the change in the common stock recorded at par value has been reclassified to additional paid-in capital on a retroactive basis. All references to shares of common stock, stock options, restricted stock units and warrants and per share data for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted to reflect the Reverse Stock Split on a retroactive basis. |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The preparation of financial statements in conformity with accounting principles generally accepted in the United States, or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the accompanying notes. Actual results could differ from those estimates. |
Reclassification, Comparability Adjustment [Policy Text Block] | Reclassifications Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year's presentation. In particular, the restricted cash classified as “Cash and cash equivalents” has been reclassified to “Restricted cash, net of current portion” in the consolidated balance sheets as of December 31, 2021 December 31, 2022 December 31, 2021. |
Consolidation, Policy [Policy Text Block] | Principles of Consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Management believes its most significant accounting estimates relate to revenue recognition, inventory valuation and the liability related to the sale of future royalties. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not |
Cash, Cash Equivalents, and Marketable Securities [Policy Text Block] | Cash, Cash Equivalents, Restricted Cash and Short-Term Investments The Company considers all highly liquid investments with an original maturity (at date of purchase) of three On May 30, 2019, not The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts in the consolidated statements of cash flows: Balance as of December 31, 2022 December 31, 2021 Cash and cash equivalents $ 15,275 $ 7,663 Restricted cash 5,000 — Restricted cash, net of current portion — 5,000 Total cash, cash equivalents, and restricted cash $ 20,275 $ 12,663 All marketable securities are classified as available for sale and consist of commercial paper, U.S. government sponsored enterprise debt securities and corporate debt securities. These securities are carried at estimated fair value, which is based on quoted market prices or observable market inputs of almost identical assets, with unrealized gains and losses included in accumulated other comprehensive income (loss). The amortized cost of securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income or expense. The cost of securities sold is based on specific identification. The Company’s investments are subject to a periodic impairment review for other-than-temporary declines in fair value. The Company’s review includes the consideration of the cause of the impairment including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses and the Company’s intent and ability to hold the investment for a period of time sufficient to allow for any anticipated recovery in the market value. When the Company determines that the decline in fair value of an investment is below its accounting basis and this decline is other than temporary, it reduces the carrying value of the security it holds and records a loss in the amount of such decline. |
Fair Value Measurement, Policy [Policy Text Block] | Fair Value of Financial Instruments The Company measures and reports its cash equivalents, investments and financial liabilities at fair value. Fair value is defined as the exchange price that would be received for an asset or an exit price paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy defines a three Level I—Unadjusted quoted prices in active markets for identical assets or liabilities; Level II—Inputs other than quoted prices included within Level I that are observable, unadjusted quoted prices in markets that are not Level III—Unobservable inputs that are supported by little or no The categorization of a financial instrument within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement. |
Segment Reporting, Policy [Policy Text Block] | Segment Information The Company operates in a single segment, the development and commercialization of innovative therapies for use in medically supervised settings. The Company’s product sales revenue consists of sales of DSUVIA in the United States, DZUVEO in Europe by Aguettant, and, through May 2021, 8, |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentration of Risk The Company invests cash that is currently not $250,000. The Company relies on a single third third DSUVIA sales are concentrated with the DoD and with a limited number of wholesalers in the United States. Zalviso was sold in Europe by Grünenthal through May 2021. July 2021, Revenue and accounts receivable have been concentrated with these customers. Revenues from customers that accounted for 10% December 31, 2022 2021 Year Ended December 31, Percent of Total Revenue 2022 2021 Aguettant 10 % 62 % Grünenthal 0 % 12 % Wholesaler A 25 % 16 % Wholesaler B 12 % 8 % Distributor A 28 % 5 % Distributor B 12 % 2 % |
Receivable [Policy Text Block] | Accounts Receivable, Net The need for a bad debt allowance is evaluated each reporting period based on the Company’s assessment of the creditworthiness of its customers or any other potential circumstances that could result in bad debt. The Company believes that the entire accounts receivable balance as of December 31, 2022 no December 31, 2022 2021. Accounts receivable, net from customers that accounted for 10% December 31, 2022 2021 As of December 31, Percent of Accounts Receivable, Net 2022 2021 Customer A 58 % 0 % Customer B 19 % 73 % Customer C 15 % 9 % |
Inventory, Policy [Policy Text Block] | Inventories, Net Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first first third The Company's policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or net realizable value approach as that used to value the inventory. |
Property, Plant and Equipment, Policy [Policy Text Block] | Property and Equipment, Net Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally three five not |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets The Company periodically assesses the impairment of long-lived assets and, if indicators of asset impairment exist, the Company assesses the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through an analysis of the undiscounted future expected operating cash flows. If impairment is indicated, the Company records the amount of such impairment for the excess of the carrying value of the asset over its estimated fair value. See Note 5, |
Business Combinations Policy [Policy Text Block] | Acquisitions The Company evaluates acquisitions of assets and other similar transactions to assess whether or not first not, not Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not not no may not |
Lessee, Leases [Policy Text Block] | Leases The Company follows the provisions of Accounting Standards Update, or ASU, 2016 02, Leases (Topic 842 not may Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the consolidated balance sheets as operating lease right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. |
Revenue [Policy Text Block] | Revenue from Contracts with Customers The Company follows the provisions of Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Product Sales Revenue The Company sells its product primarily through distributors. Revenues from product sales are recognized when distributors obtain control of the Company’s product, which occurs at a point in time, upon delivery to such distributors. These distributors subsequently resell the product to certified medically supervised healthcare settings. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and other certified medically supervised healthcare settings that provide for privately negotiated discounts with respect to the purchase of its products. For revenue recognition under bill-and-hold arrangements, wherein the customer agrees to buy product from the Company but requests delivery at a later date, the Company deems that control passes to the customer when the product is ready for delivery. The Company recognizes revenue under these types of arrangements when a signed agreement is in place, the transaction is billable, the customer has significant risk and rewards for the product and the ability to direct the asset, the product has been set aside specifically for the customer, and the product cannot be redirected to another customer. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of chargebacks, government rebates, returns, distribution fees, GPO fees and product returns. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. The amount of variable consideration that is included in the transaction price may not 606 may Chargebacks not Government Rebates Returns 6 12 may Distribution Fees GPO Fees Trade Discounts and Allowances The Company believes its estimated allowances for chargebacks, government rebates and product returns require a high degree of judgment and are subject to change based on its limited experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distribution fees, GPO fees and trade discounts and allowances do not Contract and Other Collaboration Revenue The Company generates revenue from collaboration agreements. These agreements typically include payments for upfront signing or license fees, cost reimbursements for development and manufacturing services, milestone payments, product sales, and royalties on licensee’s future product sales. Product sales related revenue under these collaboration agreements is classified as product sales revenue, while other revenue generated from collaboration agreements is classified as contract and other collaboration revenue. Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price The Company has both fixed and variable consideration. Variable consideration for product revenue is described as Net product sales in the consolidated statements of operations. For collaboration agreements, non-refundable upfront fees and product supply selling prices are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point, they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not not not For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights and material rights for discounts on manufacturing services are calculated using an income approach model and can include the following key assumptions: the development timeline, sales forecasts, costs of product sales, commercialization expenses, discount rate, the time which the manufacturing services are expected to be performed, and probabilities of technical and regulatory success. For all other performance obligations, the Company uses a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under collaboration arrangements and the period over which the Company expects to complete its performance obligations under the arrangement. The Company estimates the performance period or measure of progress at the inception of the arrangement and re-evaluates it each reporting period. This re-evaluation may |
Cost of Goods and Service [Policy Text Block] | Cost of Goods Sold Cost of goods sold for product revenue includes third Under the Grünenthal Agreements, the Company sold Zalviso to Grünenthal at predetermined, contractual transfer prices that were less than the direct costs of manufacturing and recognized indirect costs as period costs where they were in excess of normal capacity and not third |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses Research and development costs are charged to expense when incurred. Research and development expenses include salaries, employee benefits, including stock-based compensation, consultant fees, laboratory supplies, costs associated with clinical trials and manufacturing, including contract research organization fees, other professional services and allocations of corporate costs. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. |
Share-Based Payment Arrangement [Policy Text Block] | Stock-Based Compensation Compensation expense for all stock-based payment awards made to employees and directors, including employee stock options and restricted stock units related to the 2020 2020 2011 2011 2011 The Black-Scholes option pricing model requires inputs such as expected term, expected volatility and risk-free interest rate. These inputs are subjective and generally require significant analysis and judgment to develop. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the stock‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical stock price performance over the expected term of the option, which are adjusted as necessary for any other factors which may not |
Warrants, Policy [Policy Text Block] | Warrants Issued in Connection with Financings The Company accounts for issued warrants as either liability or equity in accordance with ASC 480 10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity 815 40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company s Own Stock 480 10, not 480 10, 815 40 815 40, may not 815 40, 815 40 no |
Costs Associated with Exit or Disposal Activities or Restructurings, Policy [Policy Text Block] | Restructuring Costs The Company’s restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period. In May 2022, December 31, 2022, second 2022. No |
Interest Expense, Policy [Policy Text Block] | Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties In September 2015, November 13, 2020. May 2021 May 2021. Under the Royalty Monetization, the Company had a continuing obligation to use commercially reasonable efforts to negotiate a replacement license agreement, or New Arrangement. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization was 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 was 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, was to be amortized as interest expense over the life of the liability. Consequently, the Company imputed interest on the unamortized portion of the liability and recorded interest expense, or interest income, as these estimates were updated and recorded non-cash royalty revenues and non-cash interest income (expense), net, within its consolidated statements of operations over the term of the Royalty Monetization. When the expected payments under the Royalty Monetization were lower than the gross proceeds of $65.0 million received, the Company deferred recognition of any probable contingent gain until the Royalty Monetization liability expired. See Note 11, |
Comprehensive Income, Policy [Policy Text Block] | Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive income (loss) and is disclosed in the consolidated statements of operations. For the Company, other comprehensive income (loss) consists of changes in unrealized gains and losses on the Company’s investments. |
Income Tax, Policy [Policy Text Block] | Income Taxes Deferred tax assets and liabilities are measured based on differences between the financial reporting and tax basis of assets and liabilities using enacted rates and laws that are expected to be in effect when the differences are expected to reverse. The Company records a valuation allowance for the full amount of deferred assets, which would otherwise be recorded for tax benefits relating to operating loss and tax credit carryforwards, as realization of such deferred tax assets cannot be determined to be more likely than not. |
Earnings Per Share, Policy [Policy Text Block] | Net Income (Loss) per Share of Common Stock Basic and diluted net income (loss) per common share, or EPS, are calculated in accordance with the provisions of Financial Accounting Standards Board, or FASB, ASC Topic 260, Earnings per Share The Company applies the two two may may no two no not November 2021 2022 12, 14, For additional information regarding the net income (loss) per share, see Note 16, |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Accounting Pronouncements In May 2021, 2021 04, Earnings Per Share (Topic 260 470 50 718 s Own Equity (Subtopic 815 40 s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force) 2021 14, not 2021 04 2021 04 December 15, 2021, 2021 04 2021 04. The Company adopted ASU 2021 04 January 1, 2022, 12, 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. not |
Note 1 - Organization and Sum_2
Note 1 - Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Cash and Cash Equivalents [Table Text Block] | Balance as of December 31, 2022 December 31, 2021 Cash and cash equivalents $ 15,275 $ 7,663 Restricted cash 5,000 — Restricted cash, net of current portion — 5,000 Total cash, cash equivalents, and restricted cash $ 20,275 $ 12,663 |
Schedules of Concentration of Risk, by Risk Factor [Table Text Block] | Year Ended December 31, Percent of Total Revenue 2022 2021 Aguettant 10 % 62 % Grünenthal 0 % 12 % Wholesaler A 25 % 16 % Wholesaler B 12 % 8 % Distributor A 28 % 5 % Distributor B 12 % 2 % As of December 31, Percent of Accounts Receivable, Net 2022 2021 Customer A 58 % 0 % Customer B 19 % 73 % Customer C 15 % 9 % |
Note 2 - Investments and Fair_2
Note 2 - Investments and Fair Value Measurement (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Cash, Cash Equivalents and Investments [Table Text Block] | As of December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash, cash equivalents and restricted cash: Cash $ 13,275 $ — $ — $ 13,275 Money market funds 321 — — 321 U.S. government agency securities 2,444 — — 2,444 Commercial paper 4,235 — — 4,235 Total cash, cash equivalents and restricted cash 20,275 — — 20,275 Short-term investments: Commercial paper 495 — — 495 Total short-term investments 495 — — 495 Total cash, cash equivalents, restricted cash and short-term investments $ 20,770 $ — $ — $ 20,770 As of December 31, 2021 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Cash, cash equivalents and restricted cash: Cash $ 1,443 $ — $ — $ 1,443 Money market funds 2,822 — — 2,822 Commercial paper 8,398 — — 8,398 Total cash, cash equivalents and restricted cash 12,663 — — 12,663 Short-term investments: Commercial paper 29,504 — — 29,504 Corporate debt securities 9,463 — — 9,463 Total short-term investments 38,967 — — 38,967 Total cash, cash equivalents, restricted cash and short-term investments $ 51,630 $ — $ — $ 51,630 |
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block] | As of December 31, 2022 Fair Value Level I Level II Level III Assets Money market funds $ 321 $ 321 $ — $ — U.S. government agency securities 2,444 — 2,444 — Commercial paper 4,730 — 4,730 — Total assets measured at fair value 7,495 321 7,174 Liabilities Warrant liability 7,098 — — 7,098 Total liabilities measured at fair value 7,098 — — $ 7,098 As of December 31, 2021 Fair Value Level I Level II Level III Assets Money market funds $ 2,822 $ 2,822 $ — $ — Commercial paper 37,902 — 37,902 — Corporate debt securities 9,463 — 9,463 — Total assets measured at fair value $ 50,187 $ 2,822 $ 47,365 $ — |
Note 3 - Inventories, Net (Tabl
Note 3 - Inventories, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | As of December 31, 2022 2021 Raw materials $ 796 $ 722 Work in process 338 159 Finished goods 44 230 Inventories $ 1,178 $ 1,111 |
Note 4 - Asset Acquisition (Tab
Note 4 - Asset Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Business Acquisitions, by Acquisition [Table Text Block] | Consideration Cash $ 3,536 Issuance of common stock to Lowell security holders in connection with asset acquisition 5,161 Issuance of common stock to settle Lowell’s transaction costs in connection with asset acquisition 350 Liability for issuance of 69,808 hold back shares to Lowell securityholders (1) 800 Transaction costs 2,521 Total consideration $ 12,368 IPR&D Asset Acquired Purchase price $ 12,368 Cash acquired (3,549 ) Total IPR&D asset acquired (2) $ 8,819 |
Note 5 - Property and Equipme_2
Note 5 - Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Property, Plant and Equipment [Table Text Block] | Balance as of December 31, 2022 December 31, 2021 Laboratory equipment $ 4,396 $ 4,406 Leasehold improvements 5,838 5,838 Computer equipment and software 1,565 1,589 Construction in process 8,979 13,805 Tooling 826 826 Furniture and fixtures 250 250 21,854 26,714 Less accumulated depreciation and amortization (11,593 ) (10,786 ) Property and equipment, net $ 10,261 $ 15,928 |
Note 8 - Revenue from Contrac_2
Note 8 - Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Disaggregation of Revenue [Table Text Block] | December 31, 2022 2021 Product sales: DSUVIA $ 1,588 $ 735 DZUVEO 183 — Zalviso — 270 Total product sales 1,771 1,005 Contract and collaboration revenue: License revenue — 1,696 Non-cash royalty revenue related to Royalty Monetization (Note 11) — 83 Royalty revenue — 28 Other revenue — 6 Total revenues from contract and other collaboration — 1,813 Total revenue $ 1,771 $ 2,818 |
Contract with Customer, Contract Asset, Contract Liability, and Receivable [Table Text Block] | Balance at January 1, 2021 $ 49 Additions (1) 1,237 Deductions for performance obligations satisfied: In current period (49 ) Balance at December 31, 2021 $ 1,237 Deductions for performance obligations satisfied: In current period (86 ) Balance at December 31, 2022 $ 1,151 |
Note 9 - Long-term Debt (Tables
Note 9 - Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Maturities of Long-Term Debt [Table Text Block] | 2023 $ 5,951 Total payments 5,951 Less amount representing interest (134 ) Notes payable, gross 5,817 Less: Unamortized portion of EOT Fee (26 ) Less: Unamortized discount on notes payable (28 ) Long-term debt 5,763 Less current portion (5,763 ) Long-term debt, net of current portion $ — |
Note 10 - Leases (Tables)
Note 10 - Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Lease, Cost [Table Text Block] | Year ended December 31, 2022 Year ended December 31, 2021 Operating lease costs $ 1,373 $ 1,467 Gain on derecognition of operating lease — (522 ) Sublease income — (199 ) Loss on termination of sublease — 331 Net lease costs $ 1,373 $ 1,077 December 31, December 31, 2022 2021 Weighted-average remaining lease term – operating leases (in years) 4.1 5.0 Weighted-average remaining discount rate – operating leases 12.8 % 12.8 % |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | Year: 2023 $ 2,127 2024 1,090 2025 1,040 2026 1,040 2027 415 Thereafter — Total future minimum lease payments 5,712 Less imputed interest (1,052 ) Total $ 4,660 Reported as: Operating lease liabilities $ 4,660 Operating lease liabilities, current portion (1,701 ) Operating lease liabilities, net of current portion $ 2,959 |
Note 11 - Liability Related t_2
Note 11 - Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Other Liabilities [Table Text Block] | Year ended December 31, 2022 Period from inception to December 31, 2022 Liability related to sale of future royalties — beginning balance $ 85,288 $ — Proceeds from sale of future royalties — 61,184 Non-cash royalty revenue — (1,083 ) Non-cash interest (income) expense recognized (1,136 ) 24,051 Consideration paid for termination of Royalty Monetization (100 ) (100 ) Gain on termination of liability related to sale of future royalties (84,052 ) (84,052 ) Liability related to sale of future royalties as of December 31, 2022 $ — $ — |
Note 15 - Stock-based Compens_2
Note 15 - Stock-based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Table Text Block] | December 31, 2022 December 31, 2021 Cost of goods sold $ 62 $ 92 Research and development 570 813 Selling, general and administrative 2,257 3,704 Total $ 2,889 $ 4,609 |
Share-Based Payment Arrangement, Restricted Stock and Restricted Stock Unit, Activity [Table Text Block] | Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2021 69,890 $ 35.75 Granted 57,448 33.65 Vested (29,338 ) 37.75 Forfeited (9,289 ) 31.56 Restricted stock units outstanding, December 31, 2021 88,711 $ 34.16 Granted 58,502 7.75 Vested (44,744 ) 35.46 Forfeited (19,691 ) 25.00 Restricted stock units outstanding, December 31, 2022 82,778 $ 16.97 |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Number of Stock Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (in thousands) December 31, 2021 714,085 $ 59.79 Granted 117,022 7.75 Forfeited (35,645 ) 26.46 Expired (69,839 ) 60.42 Exercised — — December 31, 2022 725,623 $ 52.98 5.3 $ — Vested and exercisable options—December 31, 2022 515,933 $ 65.76 3.9 $ — Vested and expected to vest—December 31, 2022 725,623 $ 52.80 5.3 $ — |
Schedule of Share-based Compensation, Stock Options Outstanding and Exercisable Activity [Table Text Block] | Options Outstanding Options Vested and Exercisable Exercise Prices Number of Stock Options Outstanding Weighted-Average Remaining Contractual Life (Years) Weighted-Average Exercise Price per Share Shares Subject to Stock Options Weighted-Average Exercise Price per Share $4.62 - $8.03 88,096 9.2 $ 7.54 — $ — $8.36 - $12.54 19,046 9.1 $ 8.43 — $ — $14.40 - $21.60 20,941 6.9 $ 16.93 13,643 $ 16.84 $22.40 - $33.60 11,700 8.1 $ 28.62 10,774 $ 28.58 $34.40 - $51.60 311,695 6.0 $ 41.16 217,425 $ 42.75 $52.00 - $78.00 168,275 3.5 $ 62.66 168,221 $ 62.66 $78.40 - $117.60 62,756 1.0 $ 97.95 62,756 $ 97.95 $132.00 - $198.00 20,520 1.6 $ 133.16 20,520 $ 133.16 $204.40 - $306.60 22,594 1.0 $ 206.96 22,594 $ 206.96 725,623 5.3 $ 52.98 515,933 $ 65.76 |
Time-based Stock Option [Member] | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2022 2021 Expected term (in years) 6.3 6.0 – 6.2 Risk-free interest rate 1.6% - 3.0% 0.9% - 1.3% Expected volatility 88% 90% Expected dividend rate 0% 0% |
Performance Shares [Member] | |
Notes Tables | |
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Year Ended December 31, 2022 2021 Derived service period (in years) — 2.3 – 2.6 Risk-free interest rate — 1.5% Expected volatility — 90% Expected dividend rate — 0% |
Note 16 - Net Loss Per Share _2
Note 16 - Net Loss Per Share of Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | Year ended December 31, 2022 2021 (in thousands, except share and per share amounts) Basic net income (loss) per common share: Net income (loss) $ 47,755 $ (35,099 ) Less: deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — Less: income allocated to participating securities (5,240 ) — Net income (loss) attributable to common shareholders $ 42,329 $ (35,099 ) Weighted average shares outstanding — basic 7,385,348 5,993,013 Net income (loss) — basic $ 5.73 $ (5.86 ) Year ended December 31, 2022 2021 (in thousands, except share and per share amounts) Diluted net income (loss) per common share: Net income (loss) $ 47,755 $ (35,099 ) Less: deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — Less: income allocated to participating securities (5,227 ) — Net income (loss) attributable to common shareholders $ 42,342 $ (35,099 ) Weighted average shares outstanding — basic 7,385,348 5,993,013 Dilutive effect of warrants 20,285 — Dilutive effect of RSUs 1,353 — Weighted average shares outstanding — diluted 7,406,986 5,993,013 Net income (loss) — diluted $ 5.72 $ (5.86 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | Year Ended December 31, 2022 2021 ESPP, RSUs and stock options to purchase common stock 815,710 816,421 Common stock warrants 133,833 883,833 |
Note 17 - Accrued Liabilities (
Note 17 - Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Accrued Liabilities [Table Text Block] | December 31, 2022 2021 Accrued compensation and employee benefits $ 1,944 $ 2,974 Accrued professional services 625 1,523 Accrued product returns and sales allowances 315 775 Deferred revenue 115 86 Other accrued liabilities 1,267 1,166 Total accrued liabilities $ 4,266 $ 6,524 |
Note 19 - Income Taxes (Tables)
Note 19 - Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Deferred Tax Assets [Table Text Block] | December 31, 2022 December 31, 2021 Deferred tax assets: Accruals and other $ 1,738 $ 3,989 Research credits 7,392 7,275 Net operating loss carryforward 84,325 75,452 Section 59(e) R&D expenditures 3,496 5,070 Section 174 R&D expenditures 981 — Deferred revenue — 19,666 Total deferred tax assets 97,932 111,452 Valuation allowance (97,932 ) (111,452 ) Net deferred tax assets $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Year Ended December 31, 2022 2021 Tax at statutory federal rate $ 10,031 $ (7,370 ) State tax—net of federal benefit 823 231 Acquired assets 1,728 — Stock options 611 718 Other 340 (20 ) Change in valuation allowance (13,520 ) 6,446 Provision for income taxes $ 13 $ 5 |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | Year Ended December 31, 2022 2021 Unrecognized benefit—beginning of period $ 2,635 $ 2,635 Gross increases—prior period tax positions — — Gross increases—current period tax positions 43 — Unrecognized benefit—end of period $ 2,678 $ 2,635 |
Note 21 - Restatement (Unaudi_2
Note 21 - Restatement (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Schedule of Error Corrections and Prior Period Adjustments [Table Text Block] | Three Months Ended June 30, 2022 As Previously Reported Adjustment As Restated Basic net income per common share: Net income $ 70,663 $ — $ 70,663 Income allocated to participating securities — (7,511 ) (7,511 ) Net income attributable to Common Shareholders, basic $ 70,663 $ (7,511 ) $ 63,152 Net income attributable to Common Shareholders per share, basic $ 9.60 $ (1.02 ) $ 8.58 Shares used in computing net income attributable to Common Shareholders per share, basic 7,356,952 — 7,356,952 Diluted net income (loss) per common share: Net income $ 70,663 $ — $ 70,663 Income allocated to participating securities — (7,508 ) (7,508 ) Net income attributable to Common Shareholders, diluted $ 70,663 $ (7,508 ) $ 63,155 Net income attributable to Common Shareholders per share, diluted $ 9.60 $ (1.02 ) $ 8.58 Shares used in computing net income attributable to Common Shareholders per share, diluted 7,360,453 — 7,360,453 Six Months Ended June 30, 2022 As Previously Reported Adjustment As Restated Basic net income per common share: Net income $ 61,989 $ — $ 61,989 Income allocated to participating securities — (6,619 ) (6,619 ) Net income attributable to Common Shareholders, basic $ 61,989 $ (6,619 ) $ 55,370 Net income attributable to Common Shareholders per share, basic $ 8.47 $ (0.91 ) $ 7.56 Shares used in computing net income attributable to Common Shareholders per share, basic 7,319,279 — 7,319,279 Diluted net income per common share: Net income $ 61,989 $ — $ 61,989 Income allocated to participating securities — (6,618 ) (6,618 ) Net income attributable to Common Shareholders, diluted $ 61,989 $ (6,618 ) $ 55,371 Net income attributable to Common Shareholders per share, diluted $ 8.47 $ (0.91 ) $ 7.56 Shares used in computing net income attributable to Common Shareholders per share, diluted 7,321,022 — 7,321,022 Nine Months Ended September 30, 2022 As Previously Reported Adjustment As Restated Basic net income per common share: Net income $ 55,239 $ — $ 55,239 Deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — (186 ) Income allocated to participating securities (129 ) (5,851 ) (5,980 ) Net income attributable to Common Shareholders, basic $ 54,924 $ (5,851 ) $ 49,073 Net income attributable to Common Shareholders per share, basic $ 7.48 $ (0.79 ) $ 6.69 Shares used in computing net income attributable to Common Shareholders per share, basic 7,338,853 — 7,338,853 Diluted net income per common share: Net income $ 55,239 $ — $ 55,239 Deemed dividend related to Series A Redeemable Convertible Preferred Stock (186 ) — (186 ) Income allocated to participating securities (129 ) (5,846 ) (5,975 ) Net income attributable to Common Shareholders, diluted $ 54,924 $ (5,846 ) $ 49,078 Net income attributable to Common Shareholders per share, diluted $ 7.46 $ (0.78 ) $ 6.68 Shares used in computing net income attributable to Common Shareholders per share, diluted 7,367,293 (21,339 ) 7,345,954 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Notes Tables | |
Valuation Allowances and Reserves [Table Text Block] | Additions Balance at Charged as a Balance at Beginning of Reduction to End of Description Period Revenue Deductions* Period Sales & return allowances, discounts, chargebacks and rebates: Year ended December 31, 2022 $ 780 $ 521 $ (977 ) $ 324 Year ended December 31, 2021 $ 668 $ 1,012 $ (900 ) $ 780 |
Note 1 - Organization and Sum_3
Note 1 - Organization and Summary of Significant Accounting Policies (Details Textual) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | |||||||||
Oct. 25, 2022 $ / shares | Sep. 23, 2022 | May 31, 2022 USD ($) | Jan. 01, 2022 USD ($) | Sep. 18, 2015 USD ($) | May 31, 2022 | Sep. 30, 2015 USD ($) | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) $ / shares | Dec. 31, 2022 USD ($) $ / shares | Jul. 14, 2021 USD ($) | May 30, 2019 USD ($) | |
Consideration Paid for Termination of Royalty Monetization | $ 100 | $ 100 | $ 100 | |||||||||
Non-cash Gain on Termination of Liability Related to Sale of Future Royalties | $ 84,100 | $ 84,152 | $ 0 | |||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||
Restructuring and Related Cost, Number of Positions Eliminated, Period Percent | 40% | |||||||||||
Restructuring Charges, Total | $ 500 | |||||||||||
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | ||||||||||
Royalty Arrangment Maximum Payments | 195,000 | |||||||||||
Net Proceeds from Sale of Future Royalties | $ 61,200 | $ 0 | $ 61,184 | |||||||||
Accounting Standards Update 2021-04 [Member] | ||||||||||||
Payments of Stock Issuance Costs | $ 700 | |||||||||||
Adjustments to Additional Paid in Capital, Modification of Warrants | $ 100 | |||||||||||
Loan Agreement with Oxford Finance LLC [Member] | ||||||||||||
Debt Instrument, Covenant, Minimum Required Unrestircted Cash | $ 5,000 | |||||||||||
Minimum [Member] | ||||||||||||
Property, Plant and Equipment, Useful Life (Year) | 3 years | |||||||||||
Maximum [Member] | ||||||||||||
Property, Plant and Equipment, Useful Life (Year) | 5 years | |||||||||||
Reverse Stock Split [Member] | ||||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 20 | |||||||||||
Reverse Stock Split [Member] | Minimum [Member] | ||||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 10 | |||||||||||
Reverse Stock Split [Member] | Maximum [Member] | ||||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 30 | |||||||||||
Aguettant [Member] | PFS Products [Member] | ||||||||||||
License Agreement, Milestone Payments to be Paid, Maximum | $ 24,000 |
Note 1 - Organization and Sum_4
Note 1 - Organization and Summary of Significant Accounting Policies - Schedule of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash and cash equivalents | $ 15,275 | $ 7,663 | [1] |
Restricted cash | 5,000 | 0 | |
Restricted cash, net of current portion | 0 | 5,000 | |
Total cash, cash equivalents, and restricted cash | $ 20,275 | $ 12,663 | |
[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 1 - Organization and Sum_5
Note 1 - Organization and Summary of Significant Accounting Policies - Concentration of Revenue and Accounts Receivable (Details) - Customer Concentration Risk [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue Benchmark [Member] | Aguettant [Member] | ||
Concentration risk | 10% | 62% |
Revenue Benchmark [Member] | Grunenthal [Member] | ||
Concentration risk | 0% | 12% |
Revenue Benchmark [Member] | Wholesaler A [Member] | ||
Concentration risk | 25% | 16% |
Revenue Benchmark [Member] | Wholesaler B [Member] | ||
Concentration risk | 12% | 8% |
Revenue Benchmark [Member] | Distributor A [Member] | ||
Concentration risk | 28% | 5% |
Revenue Benchmark [Member] | Distributor B [Member] | ||
Concentration risk | 12% | 2% |
Accounts Receivable [Member] | Customer A [Member] | ||
Concentration risk | 58% | 0% |
Accounts Receivable [Member] | Customer B [Member] | ||
Concentration risk | 19% | 73% |
Accounts Receivable [Member] | Customer C [Member] | ||
Concentration risk | 15% | 9% |
Note 2 - Investments and Fair_3
Note 2 - Investments and Fair Value Measurement (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Debt Securities, Available-for-sale, Realized Gain (Loss), Total | $ 0 | $ 0 |
Other-than-temporary Impairment Loss, Debt Securities, Available-for-Sale | 0 | 0 |
OCI, Debt Securities, Available-for-Sale, Transfer from Held-to-Maturity, Gain (Loss), before Adjustment, after Tax | $ 0 | $ 0 |
Note 2 - Investments and Fair_4
Note 2 - Investments and Fair Value Measurement - Summary of Cash, Cash Equivalents and Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Cash and cash equivalent, fair value | $ 12,663 | ||
Total cash, cash equivalents and restricted cash | $ 20,275 | 12,663 | $ 27,274 |
Total cash, cash equivalents, restricted cash and short-term investments | 20,770 | 51,630 | |
Total cash, cash equivalents, restricted cash and short-term investments, fair value | 20,770 | 51,630 | |
Marketable Securities [Member] | |||
Short-term investment, amortized Cost | 495 | 38,967 | |
Short-term investment, fair value | 495 | 38,967 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Commercial Paper [Member] | Marketable Securities [Member] | |||
Short-term investment, amortized Cost | 495 | 29,504 | |
Short-term investment, fair value | 495 | 29,504 | |
Gross Unrealized Gains | 0 | 0 | |
Gross Unrealized Losses | 0 | 0 | |
Corporate Debt Securities [Member] | Marketable Securities [Member] | |||
Short-term investment, amortized Cost | 9,463 | ||
Short-term investment, fair value | 9,463 | ||
Gross Unrealized Gains | 0 | ||
Gross Unrealized Losses | 0 | ||
Cash and Cash Equivalents [Member] | Cash [Member] | |||
Cash, amortized cost | 13,275 | 1,443 | |
Cash and cash equivalent, fair value | 13,275 | 1,443 | |
Cash and Cash Equivalents [Member] | Money Market Funds [Member] | |||
Cash and cash equivalent, fair value | 321 | 2,822 | |
Money market funds, amortized cost | 321 | 2,822 | |
Cash and Cash Equivalents [Member] | US Government Agencies Debt Securities [Member] | |||
Cash and cash equivalent, fair value | 2,444 | ||
U.S. government agency securities | 2,444 | ||
Cash and Cash Equivalents [Member] | Commercial Paper [Member] | |||
Cash and cash equivalent, fair value | 8,398 | ||
Short-term investment, amortized Cost | 4,235 | ||
Short-term investment, fair value | $ 4,235 | ||
Commercial paper | $ 8,398 |
Note 2 - Investments and Fair_5
Note 2 - Investments and Fair Value Measurement - Fair Value of Financial Assets and Liabilities by Level Within Fair Value Hierarchy (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets, fair value | $ 7,495 | $ 50,187 |
Liabilities, fair value | 7,098 | |
Warrant Liability [Member] | ||
Liabilities, fair value | 7,098 | |
Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 321 | 2,822 |
Liabilities, fair value | 0 | |
Fair Value, Inputs, Level 1 [Member] | Warrant Liability [Member] | ||
Liabilities, fair value | 0 | |
Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 7,174 | 47,365 |
Liabilities, fair value | 0 | |
Fair Value, Inputs, Level 2 [Member] | Warrant Liability [Member] | ||
Liabilities, fair value | 0 | |
Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | |
Liabilities, fair value | 7,098 | |
Fair Value, Inputs, Level 3 [Member] | Warrant Liability [Member] | ||
Liabilities, fair value | 7,098 | |
Money Market Funds [Member] | ||
Assets, fair value | 321 | 2,822 |
Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 321 | 2,822 |
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 |
US Government Agencies Debt Securities [Member] | ||
Assets, fair value | 2,444 | |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Assets, fair value | 0 | |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Assets, fair value | 2,444 | |
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | 0 | |
Commercial Paper [Member] | ||
Assets, fair value | 4,730 | 37,902 |
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 | 4,730 | 37,902 |
Commercial Paper [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | $ 0 | 0 |
Corporate Debt Securities [Member] | ||
Assets, fair value | 9,463 | |
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 | 9,463 | |
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Assets, fair value | $ 0 |
Note 3 - Inventories, Net (Deta
Note 3 - Inventories, Net (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Inventory Write-down | $ 0 | $ 810 |
Note 3 - Inventories, Net - Inv
Note 3 - Inventories, Net - Inventory Components (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Raw materials | $ 796 | $ 722 | |
Work in process | 338 | 159 | |
Finished goods | 44 | 230 | |
Inventories | $ 1,178 | $ 1,111 | [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 - Asset Acquisition (Det
Note 4 - Asset Acquisition (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Jan. 07, 2022 | Dec. 31, 2022 | ||
In Process Research and Development [Member] | |||
Impairment of Intangible Assets, Indefinite-Lived (Excluding Goodwill) | $ 0 | ||
Lowell Therapeutics [Member] | |||
Business Combination, Consideration Transferred, Net of Cash Acquired | $ 32,500 | ||
Cash Acquired from Acquisition | 3,549 | ||
Business Combination, Options To Purchase Capital Stock Issued and Outstanding Cancelled, Exchange for Cash | 3,500 | ||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Value | [1] | 800 | |
Business Combination, Cash and Stock Paid for Transaction Costs | 500 | ||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets, Total | [2] | 8,819 | |
Business Combination, Consideration Transferred, Total | 12,368 | ||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 6,000 | ||
Business Combination, Acquisition Related Costs | 500 | ||
Payments to Acquire Businesses, Gross | 3,536 | ||
Business Acquisition, Transaction Costs | 2,521 | ||
Lowell Therapeutics [Member] | Contingent Consideration Payable Upon Achievement of Milestones [Member] | |||
Business Combination, Contingent Consideration, Liability, Total | $ 26,000 | ||
Lowell Therapeutics [Member] | AcelRx Common Stock [Member] | |||
Business Combination, Options To Purchase Capital Stock Issued and Outstanding Cancelled, Exchange for Common Stock, Number (in shares) | 450,477 | ||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Fixed Value per Share (in dollars per share) | $ 11.46 | ||
Business Combination, Options To Purchase Capital Stock Issued and Outstanding Cancelled, Exchange for Common Stock, Value | $ 5,200 | ||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations (in shares) | 69,808 | ||
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Value | $ 800 | ||
[1]Recorded as Other long-term liabilities in the Condensed Consolidated Balance Sheets.[2]Recorded as In-process research and development asset in the Condensed Consolidated Balance Sheets. |
Note 4 - Asset Acquisition - Co
Note 4 - Asset Acquisition - Consideration for Acquisition (Details) - Lowell Therapeutics [Member] $ in Thousands | Jan. 07, 2022 USD ($) | |
Payments to Acquire Businesses, Gross | $ 3,536 | |
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 6,000 | |
Business Combination, Acquiree Common Stock to Be Held Back to Satisfy Some Obligations, Value | 800 | [1] |
Business Acquisition, Transaction Costs | 2,521 | |
Business Combination, Consideration Transferred, Total | 12,368 | |
Cash acquired | (3,549) | |
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Assets, Total | 8,819 | [2] |
Common Stock [Member] | ||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | 5,161 | |
Common Stock to Settle Transaction Costs [Member] | ||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 350 | |
[1]Recorded as Other long-term liabilities in the Condensed Consolidated Balance Sheets.[2]Recorded as In-process research and development asset in the Condensed Consolidated Balance Sheets. |
Note 5 - Property and Equipme_3
Note 5 - Property and Equipment, Net (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Tangible Asset Impairment Charges, Total | $ 4,948 | $ 0 |
Depreciation, Total | 800 | $ 1,100 |
Zalviso-related Assets [Member] | ||
Tangible Asset Impairment Charges, Total | $ 4,900 |
Note 5 - Property and Equipme_4
Note 5 - Property and Equipment, Net - Components of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Property and Equipment, Gross | $ 21,854 | $ 26,714 | |
Less accumulated depreciation and amortization | (11,593) | (10,786) | |
Property and equipment, net | 10,261 | 15,928 | [1] |
Laboratory Equipment [Member] | |||
Property and Equipment, Gross | 4,396 | 4,406 | |
Leasehold Improvements [Member] | |||
Property and Equipment, Gross | 5,838 | 5,838 | |
Computer Equipment and Software [Member] | |||
Property and Equipment, Gross | 1,565 | 1,589 | |
Construction in Progress [Member] | |||
Property and Equipment, Gross | 8,979 | 13,805 | |
Tooling [Member] | |||
Property and Equipment, Gross | 826 | 826 | |
Furniture and Fixtures [Member] | |||
Property and Equipment, Gross | $ 250 | $ 250 | |
[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 - In-license Agreement (
Note 6 - In-license Agreement (Details Textual) - Aguettant [Member] - PFS Products [Member] $ in Millions | Jul. 14, 2021 USD ($) |
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 |
Minimum [Member] | |
License Agreement, Percent of Revenue Share Payment to be Paid | 40% |
Maximum [Member] | |
License Agreement, Percent of Revenue Share Payment to be Paid | 45% |
Note 7 - Out-license Agreemen_2
Note 7 - Out-license Agreements (Details Textual) $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Jul. 14, 2021 EUR (€) | Jul. 31, 2021 | Sep. 30, 2021 USD ($) | Sep. 30, 2021 EUR (€) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 USD ($) | |
Revenue from Contract with Customer, Including Assessed Tax | $ 1,771 | $ 2,818 | |||||
DZUVEO [Member] | |||||||
Revenue from Contract with Customer, Including Assessed Tax | 183 | 0 | |||||
Aguettant [Member] | DZUVEO [Member] | |||||||
License Agreement, Renewal Term (Year) | 5 years | 5 years | |||||
License Agreement, Upfront and Maximum Milestone Payments to be Received | € | € 47 | ||||||
Proceeds form Up-front and Sales-based Milestone License Payments | $ 2,900 | € 2.5 | 2,900 | € 2.5 | |||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,700 | $ 0 | $ 1,700 | ||||
Aguettant [Member] | DZUVEO [Member] | Minimum [Member] | |||||||
License Agreement, Percent of Revenue Share Payments to be Received | 35% | ||||||
Aguettant [Member] | DZUVEO [Member] | Maximum [Member] | |||||||
License Agreement, Percent of Revenue Share Payments to be Received | 45% |
Note 8 - Revenue from Contrac_3
Note 8 - Revenue from Contracts with Customers (Details Textual) $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Jul. 14, 2021 | Jul. 31, 2021 | Sep. 30, 2021 USD ($) | Sep. 30, 2021 EUR (€) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 EUR (€) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Revenue from Contract with Customer, Including Assessed Tax | $ 1,771 | $ 2,818 | ||||||
Contract with Customer, Liability, Total | 1,151 | 1,237 | $ 49 | |||||
DZUVEO [Member] | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | 183 | 0 | ||||||
DZUVEO [Member] | Aguettant [Member] | ||||||||
Proceeds form Up-front and Sales-based Milestone License Payments | $ 2,900 | € 2.5 | 2,900 | € 2.5 | ||||
License Agreement, Milestone Payments and Revenue Share Payments to be Received | 52,200 | |||||||
License Agreement, Term (Year) | 10 years | |||||||
License Agreement, Renewal Term (Year) | 5 years | 5 years | ||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,700 | 0 | 1,700 | |||||
Contract with Customer, Liability, Total | 1,200 | |||||||
Contract with Customer, Liability, Current | 100 | |||||||
Capitalized Contract Cost, Amortization | $ 0 | $ 300 |
Note 8 - Revenue from Contrac_4
Note 8 - Revenue from Contracts with Customers - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Revenue | $ 1,771 | $ 2,818 |
DSUVIA [Member] | ||
Revenue | 1,588 | 735 |
DZUVEO [Member] | ||
Revenue | 183 | 0 |
ZALVISO [Member] | ||
Revenue | 0 | 270 |
Product [Member] | ||
Revenue | 1,771 | 1,005 |
License [Member] | ||
Revenue | 0 | 1,696 |
Non-cash Royalty [Member] | ||
Revenue | 0 | 83 |
Royalty [Member] | ||
Revenue | 0 | 28 |
Contract and Other Revenue [Member] | ||
Revenue | 0 | 6 |
Contract and Other Collaboration [Member] | ||
Revenue | $ 0 | $ 1,813 |
Note 8 - Revenue from Contrac_5
Note 8 - Revenue from Contracts with Customers - Contract Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Balance | $ 1,237 | $ 49 | |
Additions(1) | [1] | 1,237 | |
In current period | (86) | (49) | |
Balance | $ 1,151 | $ 1,237 | |
[1]Deferred revenue under the DZUVEO Agreement with Aguettant. |
Note 9 - Long-term Debt (Detail
Note 9 - Long-term Debt (Details Textual) - USD ($) | 12 Months Ended | |||
Aug. 01, 2019 | May 30, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | |
Repayments of Long-term Debt, Total | $ 8,433,000 | $ 8,833,000 | ||
Long-Term Debt, Total | 5,763,000 | |||
Amortization of Debt Discount (Premium) | 393,000 | 761,000 | ||
Leasehold Improvements, Gross | $ 400,000 | $ 1,700,000 | ||
Site Readiness Agreement [Member] | ||||
Debt Instrument, Interest Rate, Effective Percentage | 14.40% | 14.40% | ||
Debt Instrument, Periodic Payment, Principal | $ 500,000 | |||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | ||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 8,833 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 56.60 | |||
Loan Agreement with Oxford Finance LLC [Member] | ||||
Debt Instrument, Face Amount | $ 25,000,000 | |||
Repayments of Long-term Debt, Total | 8,900,000 | |||
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, After May 30, 2020, Before May 30, 2021 | 1% | |||
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% | |||
Fair Value of Contingent Put Option, Liability | $ 10,000 | |||
Long-Term Debt, Total | 5,400,000 | $ 13,300,000 | ||
Interest Expense, Debt, Total | 1,100,000 | 2,200,000 | ||
Amortization of Debt Discount (Premium) | $ 400,000 | $ 700,000 | ||
Debt Instrument, Interest Rate, Effective Percentage | 13.60% | 13.20% | ||
Loan Agreement with Oxford Finance LLC [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||
Debt Instrument, Basis Spread on Variable Rate | 6.75% |
Note 9 - Long-term Debt - Outst
Note 9 - Long-term Debt - Outstanding Future Payments of Long-term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | [1] |
2023 | $ 5,951 | ||
Total payments | 5,951 | ||
Less amount representing interest | (134) | ||
Notes payable, gross | 5,817 | ||
Less: Unamortized portion of EOT Fee | (26) | ||
Less: Unamortized discount on notes payable | (28) | ||
Long-term debt | 5,763 | ||
Less current portion | (5,763) | $ (8,796) | |
Long-term debt, net of current portion | $ 0 | $ 5,007 | |
[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 10 - Leases (Details Textu
Note 10 - Leases (Details Textual) | 12 Months Ended | ||||||
Mar. 26, 2021 USD ($) | Dec. 12, 2012 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) ft² | Apr. 30, 2021 USD ($) | Apr. 21, 2021 | ||
Gain (Loss) on Termination of Lease | $ 500,000 | $ 0 | $ 522,000 | ||||
Operating Lease, Right-of-Use Asset | 3,595,000 | $ 4,302,000 | [1] | ||||
Lessee, Operating Lease, Renewal Term (Year) | 2 years | ||||||
Lessee, Operating Lease, Notice Period (Year) | 18 years | ||||||
Lessee, Operating Lease, Annual Overhead Fee Payments | $ 200,000 | ||||||
Catalent Pharma Solutions [Member] | |||||||
Lessee, Operating Lease, Term of Contract (Year) | 5 years | ||||||
Lessee, Operating Lease, Renewal Term (Year) | 2 years | ||||||
Operating Lease, Expense | $ 1,000,000 | ||||||
Prepaid Expenses and Other Current Assets [Member] | |||||||
Lessee, Operating Sublease, Deferred Costs | $ 300,000 | ||||||
Lease for Corporate Headquarters in Hayward, California [Member] | |||||||
Area of Real Estate Property (Square Foot) | ft² | 12,106 | ||||||
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 | ||||||
[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 10 - Leases - Operating Le
Note 10 - Leases - Operating Lease Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Mar. 26, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating lease costs | $ 1,373 | $ 1,467 | |
Gain on derecognition of operating lease | $ (500) | 0 | (522) |
Sublease income | 0 | (199) | |
Loss on termination of sublease | 0 | 331 | |
Net lease costs | $ 1,373 | $ 1,077 | |
Weighted-average remaining lease term – operating leases (in years) (Year) | 4 years 1 month 6 days | 5 years | |
Weighted-average remaining discount rate – operating leases | 12.80% | 12.80% |
Note 10 - Leases - Maturities o
Note 10 - Leases - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | [1] |
2023 | $ 2,127 | ||
2024 | 1,090 | ||
2025 | 1,040 | ||
2026 | 1,040 | ||
2027 | 415 | ||
Thereafter | 0 | ||
Total future minimum lease payments | 5,712 | ||
Less imputed interest | (1,052) | ||
Total | 4,660 | ||
Operating lease liabilities | 4,660 | ||
Operating lease liabilities, current portion | (1,701) | $ (1,068) | |
Operating lease liabilities, net of current portion | $ 2,959 | $ 3,750 | |
[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 11 - Liability Related t_3
Note 11 - Liability Related to Sale of Future Royalties (Details Textual) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | |||
May 31, 2022 | Sep. 18, 2015 | Sep. 30, 2015 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Proceeds From Sale of Royalty and Milestone Rights | $ 65,000 | $ 65,000 | ||||
Consideration Paid for Termination of Royalty Monetization | $ 100 | $ 100 | $ 100 | |||
Non-cash Gain on Termination of Liability Related to Sale of Future Royalties | $ 84,100 | $ 84,152 | $ 0 | |||
Effective Annual Interest Rate | 3.20% | 3.50% | ||||
SWK [Member] | ||||||
Percentage of Royalties and Rights Under Agreement | 75% | |||||
SWK [Member] | First Four Commercial Milestones [Member] | ||||||
Percentage of Royalties and Rights Under Agreement | 80% | |||||
Commercial Milestones Value Maximum Amount Available | $ 35,600 | |||||
AcelRX [Member] | First Four Commercial Milestones [Member] | ||||||
Commercial Milestones Value Maximum Amount Available | $ 44,500 |
Note 11 - Liability Related t_4
Note 11 - Liability Related to Sale of Future Royalties - Activity of Liability Related to Sale of Future Royalties (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | 87 Months Ended | ||
May 31, 2022 | Sep. 30, 2015 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2022 | |
Liability related to sale of future royalties — beginning balance | $ 85,288 | $ 0 | |||
Proceeds from sale of future royalties | $ 61,200 | 0 | 61,184 | ||
Non-cash royalty revenue | 0 | (1,083) | |||
Non-cash interest (income) expense recognized | (1,136) | $ (3,038) | 24,051 | ||
Consideration paid for termination of Royalty Monetization | $ (100) | (100) | (100) | ||
Gain on termination of liability related to sale of future royalties | (84,052) | $ 0 | (84,052) | ||
Liability related to sale of future royalties as of December 31, 2022 | $ 0 | $ 0 |
Note 12 - Warrants (Details Tex
Note 12 - Warrants (Details Textual) | 1 Months Ended | 12 Months Ended | |||||||||
Dec. 29, 2022 USD ($) $ / shares shares | Dec. 27, 2022 $ / shares shares | Aug. 03, 2022 USD ($) $ / shares shares | Nov. 17, 2021 USD ($) $ / shares shares | Nov. 15, 2021 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares | Oct. 25, 2022 $ / shares | Dec. 31, 2020 shares | May 30, 2019 USD ($) $ / shares yr shares | |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||||
Equity Issuance Costs, Modification of Warrants | $ 47,000 | $ 0 | |||||||||
Warrants and Rights Outstanding | $ 7,098,000 | $ 7,098,000 | 0 | ||||||||
Redeemable Convertible Preferred Stock [Member] | |||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 3,000 | ||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 129,000 | ||||||||||
The 2022 Prefunded Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 2,632,898 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 0.0001 | ||||||||||
Equity Offering, Price Per Unit (in dollars per share) | $ / shares | $ 2.22615 | ||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | $ / shares | 2.22615 | ||||||||||
Class of Warrant or Right, Outstanding (in shares) | shares | 2,632,898 | 2,632,898 | |||||||||
Common Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 4,227,052 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | ||||||||||
Class of Warrant or Right, Outstanding (in shares) | shares | 4,227,052 | 4,227,052 | |||||||||
December 2022 Financing [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | ||||||||||
Warrants and Rights Outstanding | $ 7,100,000 | ||||||||||
Proceeds from Issuance of Warrants | $ 335,000 | ||||||||||
December 2022 Financing [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | $ / shares | 2.13 | ||||||||||
December 2022 Financing [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 6 | ||||||||||
December 2022 Financing [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.9544 | ||||||||||
December 2022 Financing [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.0393 | ||||||||||
December 2022 Financing [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0 | ||||||||||
December 2022 Financing [Member] | Minimum [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 1 | ||||||||||
August 2022 LPC Warrant [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 81,150 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | $ 4.07 | $ 2.07 | $ 2.07 | |||||||
Warrants and Rights Outstanding | $ 300,000 | ||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 110,000 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | $ / shares | 4.44 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 5.5 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.8994 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.0286 | ||||||||||
August 2022 LPC Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0 | ||||||||||
November 2021 Financing Warrants [Member] | |||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 875,000 | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 875,000 | 125,000 | 125,000 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 20 | $ 20 | $ 20 | $ 20 | |||||||
Warrants and Rights Outstanding | $ 5,600,000 | $ 8,600,000 | |||||||||
Proceeds from Issuance of Warrants | $ 5,600,000 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 14.92 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 5 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.9177 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.0126 | ||||||||||
November 2021 Financing Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0 | ||||||||||
November 2021 Financing Warrants [Member] | Maximum [Member] | |||||||||||
Class of Warrant or Right, Required Percentage of Ownership to Become Exercisable | 9.99% | ||||||||||
Modified November 2021 Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 750,000 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | ||||||||||
Equity Issuance Costs, Modification of Warrants | $ 800,000 | ||||||||||
Modified November 2021 Warrants [Member] | Additional Paid-in Capital [Member] | |||||||||||
Equity Issuance Costs, Modification of Warrants | 100,000 | ||||||||||
Modified November 2021 Warrants [Member] | Selling, General and Administrative Expenses [Member] | |||||||||||
Equity Issuance Costs, Modification of Warrants | $ 700,000 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | $ / shares | 2.13 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 6 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.9544 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.0393 | ||||||||||
Modified November 2021 Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 8,833 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 56.60 | ||||||||||
Warrants and Rights Outstanding | $ 400,000 | ||||||||||
Class of Warrant or Right, Outstanding (in shares) | shares | 8,833 | ||||||||||
Warrants and Rights Outstanding, Term (Year) | 10 years | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | Measurement Input, Share Price [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | $ / shares | 53.20 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | Measurement Input, Expected Term [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | yr | 10 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | Measurement Input, Price Volatility [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.8022 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0.0222 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | Measurement Input, Expected Dividend Rate [Member] | |||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | 0 | ||||||||||
Warrant In Connection with Oxford Finance Loan Agreement [Member] | Measurement Input, Exercise Price [Member] | |||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 56.60 | ||||||||||
December 2022 Financing [Member] | |||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 748,744 | ||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | ||||||||||
Equity Offering, Price Per Unit (in dollars per share) | $ / shares | $ 2.22625 | ||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 7,500,000 | ||||||||||
Payments of Stock Issuance Costs | 1,700,000 | ||||||||||
Equity Issuance Costs, Modification of Warrants | $ 800,000 | ||||||||||
Proceeds from Issuance or Sale of Equity, After Warrant Adjustment | $ 400,000 | ||||||||||
Proceeds from Issuance of Common Stock | 95,000 | ||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 6,600,000 | ||||||||||
Securities Purchase Agreement [Member] | |||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 300,000 | ||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 200,000 | ||||||||||
2021 Registered Direct Offering [Member] | |||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 875,000 | ||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 14,000,000 | $ 14,000,000 | |||||||||
Proceeds from Issuance of Common Stock | $ 7,528,000 | 0 | |||||||||
Proceeds from Issuance of Warrants | $ 0 | $ 13,918,000 | |||||||||
2021 Registered Direct Offering [Member] | Measurement Input, Risk Free Interest Rate [Member] | |||||||||||
Proceeds from Issuance or Sale of Equity, Total | 14,000,000 | ||||||||||
Proceeds from Issuance of Common Stock | $ 8,400,000 | ||||||||||
2021 Registered Direct Offering [Member] | November 2021 Financing Warrants [Member] | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 875,000 |
Note 13 - Commitments and Con_2
Note 13 - Commitments and Contingencies (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] | ||
Loss Contingency, Number of Defendants | 10 |
Note 14 - Stockholders' Equit_2
Note 14 - Stockholders' Equity (Deficit) (Details Textual) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||||||||||||||
Dec. 29, 2022 USD ($) $ / shares | Dec. 27, 2022 $ / shares shares | Oct. 25, 2022 $ / shares | Oct. 12, 2022 USD ($) shares | Sep. 23, 2022 | Aug. 03, 2022 USD ($) $ / shares shares | Nov. 17, 2021 USD ($) $ / shares shares | Nov. 15, 2021 USD ($) $ / shares shares | Jan. 27, 2021 $ / shares shares | Jan. 27, 2021 USD ($) $ / shares shares | Jan. 22, 2021 $ / shares shares | May 09, 2019 USD ($) | Jun. 21, 2016 USD ($) | Dec. 31, 2022 USD ($) $ / shares shares | Jan. 31, 2011 shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) $ / shares shares | Jun. 17, 2021 shares | Jun. 16, 2020 shares | Dec. 31, 2011 | |||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 790,000 | $ 44,716,000 | |||||||||||||||||||||
Share Price (in dollars per share) | $ / shares | $ 14.92 | ||||||||||||||||||||||
Common Stock, Value, Issued, Ending Balance | [1] | $ 8,000 | $ 8,000 | 8,000 | 7,000 | [2] | |||||||||||||||||
Warrants and Rights Outstanding | $ 7,098,000 | $ 7,098,000 | $ 7,098,000 | $ 0 | |||||||||||||||||||
Employee Stock Purchase Plan, Shares Issued, Weighted Average Fair Value (in dollars per share) | $ / shares | $ 6.82 | $ 20.23 | |||||||||||||||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||||||||||||||||
Share-Based Payment Arrangement, Shares Withheld for Tax Withholding Obligation (in shares) | shares | 0 | ||||||||||||||||||||||
2011 Equity Incentive Plan [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other Than Options, Outstanding (in shares) | shares | 100,000 | ||||||||||||||||||||||
Stock Option Plan Option Reserve Annual Increase as Percentage of Outstanding Shares Allowed | 4% | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | shares | 300,000 | ||||||||||||||||||||||
The 2020 Equity Incentive Plan [Member] | |||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | shares | 200,000 | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | shares | 342,827 | 342,827 | 342,827 | ||||||||||||||||||||
Amended ESPP [Member] | |||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | shares | 300,000 | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | shares | 211,876 | 211,876 | 211,876 | ||||||||||||||||||||
Employee Stock Purchase Plan (ESPP) [Member] | |||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares) | shares | 10,941 | 10,941 | 10,941 | 200,000 | |||||||||||||||||||
Securities Purchase Agreement [Member] | |||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 300,000 | ||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 200,000 | ||||||||||||||||||||||
December 2022 Financing [Member] | |||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 748,744 | ||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 7,500,000 | ||||||||||||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | ||||||||||||||||||||||
Equity Offering, Price Per Unit (in dollars per share) | $ / shares | $ 2.22625 | ||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 6,600,000 | ||||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 95,000 | ||||||||||||||||||||||
Private Placement [Member] | Armistice Capital and Rock Springs Capital [Member] | |||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 108,750 | 833,750 | 725,000 | ||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 28,900,000 | ||||||||||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ / shares | $ 35.25 | $ 35.25 | $ 35.25 | ||||||||||||||||||||
2021 Registered Direct Offering [Member] | |||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 875,000 | ||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Total | $ 14,000,000 | $ 14,000,000 | |||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 7,528,000 | $ 0 | |||||||||||||||||||||
Shares Issued, Price Per Share (in dollars per share) | $ / shares | $ 16 | ||||||||||||||||||||||
Net Proceeds from Issuance of Common Stock and Exercise of Warrants | $ 13,900,000 | ||||||||||||||||||||||
Stock Issued During Period, Value, New Issues | 13,100,000 | ||||||||||||||||||||||
Common Stock, Value, Issued, Ending Balance | $ 8,400,000 | ||||||||||||||||||||||
ATM Agreement [Member] | |||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 0.1 | 200,000 | |||||||||||||||||||||
Proceeds from Issuance of Common Stock | $ 458,000 | $ 7,474,000 | |||||||||||||||||||||
Aggregate Offering Price, Maximum | $ 80,000,000 | $ 40,000,000 | $ 35,600,000 | ||||||||||||||||||||
Aggregate Offering Price, Increase During Period | $ 40,000,000 | ||||||||||||||||||||||
August 2022 LPC Warrant [Member] | |||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 81,150 | ||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | $ 4.07 | $ 2.07 | $ 2.07 | $ 2.07 | ||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 110,000 | ||||||||||||||||||||||
Warrants and Rights Outstanding | $ 300,000 | ||||||||||||||||||||||
The 2022 Prefunded Warrants [Member] | |||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 2,632,898 | ||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | 0.0001 | ||||||||||||||||||||||
Equity Offering, Price Per Unit (in dollars per share) | $ / shares | $ 2.22615 | ||||||||||||||||||||||
Warrants and Rights Outstanding, Measurement Input (in dollars per share) | $ / shares | 2.22615 | ||||||||||||||||||||||
Common Warrants [Member] | |||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 4,227,052 | ||||||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 2.07 | ||||||||||||||||||||||
November 2021 Financing Warrants [Member] | |||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 875,000 | ||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 875,000 | 125,000 | 125,000 | 125,000 | |||||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ / shares | $ 20 | $ 20 | $ 20 | $ 20 | $ 20 | ||||||||||||||||||
Warrants and Rights Outstanding | $ 5,600,000 | $ 8,600,000 | |||||||||||||||||||||
November 2021 Financing Warrants [Member] | 2021 Registered Direct Offering [Member] | |||||||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | shares | 875,000 | ||||||||||||||||||||||
Redeemable Convertible Preferred Stock [Member] | |||||||||||||||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | shares | 3,000 | ||||||||||||||||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | ||||||||||||||||||||||
Preferred Stock Stated Value Per Share (in dollars per share) | $ / shares | $ 100 | ||||||||||||||||||||||
Temporary Equity, Carrying Amount, Attributable to Parent | $ 100,000 | ||||||||||||||||||||||
Preferred Stock, Redemption Price Per Share (in dollars per share) | $ / shares | $ 3.70 | ||||||||||||||||||||||
Preferred Stock, Company Option to Convert, Percentage of Stated Value | 105% | 105% | |||||||||||||||||||||
Preferred Stock, Purchaser Option to Convert, Percentage of Stated Value | 110% | ||||||||||||||||||||||
Dividends, Preferred Stock, Total | $ 200,000 | ||||||||||||||||||||||
Reverse Stock Split, Preferred Stock Votes per Share | 1,000,000 | ||||||||||||||||||||||
Preferred Stock, Shares Outstanding, Ending Balance (in shares) | shares | 3,000 | ||||||||||||||||||||||
Preferred Stock, Redemption Amount | $ 300,000 | ||||||||||||||||||||||
Preferred Stock, Elimination of Designation, Shares (in shares) | shares | 3,000 | ||||||||||||||||||||||
Proceeds from Issuance or Sale of Equity, Net | $ 129,000 | ||||||||||||||||||||||
Stock Issued During Period, Value, New Issues | $ 110,000 | ||||||||||||||||||||||
Maximum [Member] | 2011 Equity Incentive Plan [Member] | |||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares to be Added (in shares) | shares | 700,000 | ||||||||||||||||||||||
Reverse Stock Split [Member] | |||||||||||||||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 20 | ||||||||||||||||||||||
Reverse Stock Split [Member] | Maximum [Member] | |||||||||||||||||||||||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 30 | ||||||||||||||||||||||
[1]Adjusted to give retroactive effect to a 1-for-20 reverse stock split effective as of 5:01 p.m. Eastern Time on October 25, 2022.[2]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 15 - Stock-based Compens_3
Note 15 - Stock-based Compensation (Details Textual) - USD ($) | 12 Months Ended | ||
Mar. 03, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 5.80 | $ 24.74 | |
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount, Total | $ 1,800,000 | ||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 1 year 9 months 18 days | ||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Vested in Period, Fair Value | $ 1,700,000 | $ 2,400,000 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 0 | $ 5,700 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 117,022 | ||
The 2020 Equity Incentive Plan [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 342,827 | ||
The 2020 Equity Incentive Plan [Member] | Performance Shares [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares (in shares) | 0 | ||
The 2020 Equity Incentive Plan [Member] | Executive Officer [Member] | Performance Shares [Member] | |||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ 1.88 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross (in shares) | 1,270,000 |
Note 15 - Stock-based Compens_4
Note 15 - Stock-based Compensation - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Stock-based compensation expense | $ 2,889 | $ 4,609 |
Cost of Sales [Member] | ||
Stock-based compensation expense | 62 | 92 |
Research and Development Expense [Member] | ||
Stock-based compensation expense | 570 | 813 |
Selling, General and Administrative Expenses [Member] | ||
Stock-based compensation expense | $ 2,257 | $ 3,704 |
Note 15 - Stock-based Compens_5
Note 15 - Stock-based Compensation - Restricted Stock Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Restricted stock units outstanding (in shares) | 88,711 | 69,890 |
Restricted stock units weighted average outstanding (in dollars per share) | $ 34.16 | $ 35.75 |
Granted (in shares) | 58,502 | 57,448 |
Weighted average grant date fair value, granted (in dollars per share) | $ 7.75 | $ 33.65 |
Vested (in shares) | (44,744) | (29,338) |
Weighted average grant date fair value, vested (in dollars per share) | $ 35.46 | $ 37.75 |
Forfeited (in shares) | (19,691) | (9,289) |
Weighted average grant date fair value, forfeited (in dollars per share) | $ 25 | $ 31.56 |
Restricted stock units outstanding (in shares) | 82,778 | 88,711 |
Restricted stock units weighted average outstanding (in dollars per share) | $ 16.97 | $ 34.16 |
Note 15 - Stock-based Compens_6
Note 15 - Stock-based Compensation - Option Activity (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Outstanding (in shares) | shares | 714,085 |
Outstanding (in dollars per share) | $ / shares | $ 59.79 |
Granted (in shares) | shares | 117,022 |
Granted, weighted-average exercise price (in dollars per share) | $ / shares | $ 7.75 |
Forfeited (in shares) | shares | (35,645) |
Forfeited, weighted-average exercise price (in dollars per share) | $ / shares | $ 26.46 |
Expired (in shares) | shares | (69,839) |
Expired, weighted-average exercise price (in dollars per share) | $ / shares | $ 60.42 |
Exercised (in shares) | shares | 0 |
Exercised, weighted-average exercise price (in dollars per share) | $ / shares | $ 0 |
Outstanding (in shares) | shares | 725,623 |
Outstanding, weighted-average exercise price (in dollars per share) | $ / shares | $ 52.98 |
Outstanding, weighted-average remaining contractual life (Year) | 5 years 3 months 18 days |
Outstanding, aggregate intrinsic value | $ | $ 0 |
Vested and exercisable options (in shares) | shares | 515,933 |
Vested and exercisable options, weighted-average exercise price (in dollars per share) | $ / shares | $ 65.76 |
Vested and exercisable options, weighted-average remaining contractual life (Year) | 3 years 10 months 24 days |
Vested and exercisable options, aggregate intrinsic value | $ | $ 0 |
Vested and expected to vest (in shares) | shares | 725,623 |
Vested and expected to vest, weighted-average exercise price (in dollars per share) | $ / shares | $ 52.80 |
Vested and expected to vest, weighted-average remaining contractual life (Year) | 5 years 3 months 18 days |
Vested and expected to vest, aggregate intrinsic value | $ | $ 0 |
Note 15 - Stock-based Compens_7
Note 15 - Stock-based Compensation - Stock Options Outstanding, Vested and Exercisable (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | ||
Number of Stock Options Outstanding (in shares) | 725,623 | 714,085 |
Weighted-average Remaining Contractual LIfe (Year) | 5 years 3 months 18 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 52.98 | $ 59.79 |
Shares Subject to Stock Options (in shares) | 515,933 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 65.76 | |
Exercise Price Range 1 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 4.62 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 8.03 | |
Number of Stock Options Outstanding (in shares) | 88,096 | |
Weighted-average Remaining Contractual LIfe (Year) | 9 years 2 months 12 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 7.54 | |
Shares Subject to Stock Options (in shares) | 0 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 0 | |
Exercise Price Range 2 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 8.36 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 12.54 | |
Number of Stock Options Outstanding (in shares) | 19,046 | |
Weighted-average Remaining Contractual LIfe (Year) | 9 years 1 month 6 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 8.43 | |
Shares Subject to Stock Options (in shares) | 0 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 0 | |
Exercise Price Range 3 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 14.40 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 21.60 | |
Number of Stock Options Outstanding (in shares) | 20,941 | |
Weighted-average Remaining Contractual LIfe (Year) | 6 years 10 months 24 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 16.93 | |
Shares Subject to Stock Options (in shares) | 13,643 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 16.84 | |
Exercise Price Range 4 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 22.40 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 33.60 | |
Number of Stock Options Outstanding (in shares) | 11,700 | |
Weighted-average Remaining Contractual LIfe (Year) | 8 years 1 month 6 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 28.62 | |
Shares Subject to Stock Options (in shares) | 10,774 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 28.58 | |
Exercise Price Range 5 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 34.40 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 51.60 | |
Number of Stock Options Outstanding (in shares) | 311,695 | |
Weighted-average Remaining Contractual LIfe (Year) | 6 years | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 41.16 | |
Shares Subject to Stock Options (in shares) | 217,425 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 42.75 | |
Exercise Price Range 6 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 52 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 78 | |
Number of Stock Options Outstanding (in shares) | 168,275 | |
Weighted-average Remaining Contractual LIfe (Year) | 3 years 6 months | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 62.66 | |
Shares Subject to Stock Options (in shares) | 168,221 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 62.66 | |
Exercise Price Range 7 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 78.40 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 117.60 | |
Number of Stock Options Outstanding (in shares) | 62,756 | |
Weighted-average Remaining Contractual LIfe (Year) | 1 year | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 97.95 | |
Shares Subject to Stock Options (in shares) | 62,756 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 97.95 | |
Exercise Price Range 8 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 132 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 198 | |
Number of Stock Options Outstanding (in shares) | 20,520 | |
Weighted-average Remaining Contractual LIfe (Year) | 1 year 7 months 6 days | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 133.16 | |
Shares Subject to Stock Options (in shares) | 20,520 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 133.16 | |
Exercise Price Range 9 [Member] | ||
Exercise Price Range, Lower Range Limit (in dollars per share) | 204.40 | |
Exercise Price Range, Upper Range Limit (in dollars per share) | $ 306.60 | |
Number of Stock Options Outstanding (in shares) | 22,594 | |
Weighted-average Remaining Contractual LIfe (Year) | 1 year | |
Options Outstanding, Weighted-average Exercise Price Per Share (in dollars per share) | $ 206.96 | |
Shares Subject to Stock Options (in shares) | 22,594 | |
Options Vested and Exercisable, Weighted-average Exercise Price Per Share (in dollars per share) | $ 206.96 |
Note 15 - Stock-based Compens_8
Note 15 - Stock-based Compensation - Assumptions to Calculate Fair Value of Each Performance-based Stock Option (Details) - Performance Shares [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Risk-free interest rate | 0% | 1.50% |
Expected volatility | 0% | 90% |
Expected dividend rate | 0% | 0% |
Minimum [Member] | ||
Derived service period (in years) (Year) | 2 years 3 months 18 days | |
Maximum [Member] | ||
Derived service period (in years) (Year) | 2 years 7 months 6 days |
Note 15 - Stock-based Compens_9
Note 15 - Stock-based Compensation - Assumptions to Calculate Fair Value of Each Employee Stock Option (Details) - Time-based Stock Option [Member] | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Expected term (Year) | 6 years 3 months 18 days | |
Risk-free interest rate, minimum | 1.60% | |
Risk-free interest rate, maximum | 3% | |
Expected volatility | 88% | 90% |
Expected dividend rate | 0% | 0% |
Minimum [Member] | ||
Expected term (Year) | 6 years | |
Risk-free interest rate, minimum | 0.90% | |
Maximum [Member] | ||
Expected term (Year) | 6 years 2 months 12 days | |
Risk-free interest rate, maximum | 1.30% |
Note 16 - Net Loss Per Share _3
Note 16 - Net Loss Per Share of Common Stock (Details Textual) | Dec. 29, 2022 $ / shares |
The 2022 Prefunded Warrants [Member] | |
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share) | $ 0.0001 |
Note 16 - Net Income (Loss) per
Note 16 - Net Income (Loss) per Share of Common Stock - Computation of Basic and Diluted Net Income (Loss) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Net income (loss) | $ 70,663 | $ 61,989 | $ 55,239 | $ 47,755 | $ (35,099) |
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | (186) | (186) | 0 | ||
Income allocated to participating securities | (7,511) | (6,619) | (5,980) | (5,240) | 0 |
Net income (loss) attributable to Common Shareholders, basic | $ 63,152 | $ 55,370 | $ 49,073 | $ 42,329 | $ (35,099) |
Weighted average shares outstanding — basic (in shares) | 7,385,348 | 5,993,013 | |||
Net income (loss) — basic (in dollars per share) | $ 8.58 | $ 7.56 | $ 6.69 | $ 5.73 | $ (5.86) |
Income allocated to participating securities | $ (7,508) | $ (6,618) | $ (5,975) | $ (5,227) | $ 0 |
Net income (loss) attributable to common shareholders | $ 63,155 | $ 55,371 | $ 49,078 | $ 42,342 | $ (35,099) |
Shares used in computing net income (loss) per share of common stock, basic–(Note 16) (in shares) | 7,356,952 | 7,319,279 | 7,338,853 | 7,385,348 | 5,993,013 |
Dilutive effect of warrants (in shares) | 20,285 | 0 | |||
Dilutive effect of RSUs (in shares) | 1,353 | 0 | |||
Weighted average shares outstanding — diluted (in shares) | 7,360,453 | 7,321,022 | 7,345,954 | 7,406,986 | 5,993,013 |
Net income (loss) — diluted (in dollars per share) | $ 8.58 | $ 7.56 | $ 6.68 | $ 5.72 | $ (5.86) |
Note 16 - Net Loss Per Share _4
Note 16 - Net Loss Per Share of Common Stock - Common Stock Excluded From Computation of Diluted Net Loss Per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
RSU's, ESPP, and Employee Stock Options [Member] | ||
Antidilutive securities (in shares) | 815,710 | 816,421 |
Warrant [Member] | ||
Antidilutive securities (in shares) | 133,833 | 883,833 |
Note 17 - Accrued Liabilities -
Note 17 - Accrued Liabilities - Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | |
Accrued compensation and employee benefits | $ 1,944 | $ 2,974 | |
Accrued professional services | 625 | 1,523 | |
Accrued product returns and sales allowances | 315 | 775 | |
Deferred revenue | 115 | 86 | |
Other accrued liabilities | 1,267 | 1,166 | |
Total accrued liabilities | $ 4,266 | $ 6,524 | [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 18 - 401(k) Plan (Details
Note 18 - 401(k) Plan (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2019 | |
Defined Contribution Plan, Employer Discretionary Contribution Percentage | 4% | ||
Contributions by Employer to Postemployment Benefit Obligations | $ 0.3 | $ 0.4 |
Note 19 - Income Taxes (Details
Note 19 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Expense (Benefit), Total | $ 13 | $ 5 |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 13,500 | 6,400 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued, Total | $ 0 | 0 |
Open Tax Year | 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2016 2017 2018 2019 2020 2021 2022 | |
Increase (Decrease) in Employee Related Liabilities, Total | $ 1,400 | |
Subject to Expiration [Member] | ||
Operating Loss Carryforwards | $ 1,400 | |
Research Tax Credit Carryforward [Member] | Subject to Expiration [Member] | ||
Tax Credit Carryforward, Amount | 26 | |
Domestic Tax Authority [Member] | ||
Operating Loss Carryforwards | 346,400 | |
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | 6,600 | |
Domestic Tax Authority [Member] | Before Tax Year 2018 [Member] | ||
Operating Loss Carryforwards | 114,900 | |
Domestic Tax Authority [Member] | Tax Years 2018 to 2022 [Member] | ||
Operating Loss Carryforwards | 231,500 | |
State and Local Jurisdiction [Member] | ||
Operating Loss Carryforwards | 167,900 | |
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||
Tax Credit Carryforward, Amount | $ 4,100 |
Note 19 - Income Taxes - Net De
Note 19 - Income Taxes - Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accruals and other | $ 1,738 | $ 3,989 |
Research credits | 7,392 | 7,275 |
Net operating loss carryforward | 84,325 | 75,452 |
Section 59(e) R&D expenditures | 3,496 | 5,070 |
Section 174 R&D expenditures | 981 | 0 |
Deferred revenue | 0 | 19,666 |
Total deferred tax assets | 97,932 | 111,452 |
Valuation allowance | (97,932) | (111,452) |
Net deferred tax assets | $ 0 | $ 0 |
Note 19 - Income Taxes - Reconc
Note 19 - Income Taxes - Reconciliation of Statutory Federal Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Tax at statutory federal rate | $ 10,031 | $ (7,370) |
State tax—net of federal benefit | 823 | 231 |
Acquired assets | 1,728 | 0 |
Stock options | 611 | 718 |
Other | 340 | (20) |
Change in valuation allowance | (13,520) | 6,446 |
Provision for income taxes | $ 13 | $ 5 |
Note 19 - Income Taxes - Reco_2
Note 19 - Income Taxes - Reconciliation of Beginning and Ending Balance of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Unrecognized benefit—beginning of period | $ 2,635 | $ 2,635 |
Gross increases—prior period tax positions | 0 | 0 |
Gross increases—current period tax positions | 43 | 0 |
Unrecognized benefit—end of period | $ 2,678 | $ 2,635 |
Note 20 - Subsequent Events (De
Note 20 - Subsequent Events (Details Textual) - Subsequent Event [Member] $ in Millions | 3 Months Ended | ||
Mar. 31, 2023 shares | Mar. 12, 2023 USD ($) | Mar. 12, 2023 EUR (€) | |
The 2022 Prefunded Warrants [Member] | |||
Stock Issued During Period, Shares, Common Stock Warrants Exercised (in shares) | shares | 2,632,898 | ||
Aguettant [Member] | PFS Products [Member] | |||
Licensing Agreement, Complementary Payment | € | € 1,500,000 | ||
DSUVIA Agreement [Member] | |||
Asset Acquisition, Milestone Payments, Percent of Consideration | 20% | 20% | |
DSUVIA Agreement [Member] | Excluding the Department of Defense or Aguettant [Member] | |||
Asset Acquisition, Quarterly Payments, Percent of Net Product Sales | 15% | 15% | |
DSUVIA Agreement [Member] | Department of Defense [Member] | |||
Asset Acquisition, Quarterly Payments, Percent of Net Product Sales | 75% | 75% | |
DSUVIA Agreement [Member] | Maximum [Member] | |||
Asset Acquisition, Milestone Payments to be Received | $ | $ 116.5 |
Note 21 - Restatement (Unaudi_3
Note 21 - Restatement (Unaudited) - Condensed Consolidated Statements of Operations (Unaudited) (As Restated) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2022 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Net income | $ 70,663 | $ 61,989 | $ 55,239 | $ 47,755 | $ (35,099) |
Income allocated to participating securities | (7,511) | (6,619) | (5,980) | (5,240) | 0 |
Net income attributable to Common Shareholders, basic | $ 63,152 | $ 55,370 | $ 49,073 | $ 42,329 | $ (35,099) |
Net income attributable to Common Shareholders per share, basic (in dollars per share) | $ 8.58 | $ 7.56 | $ 6.69 | $ 5.73 | $ (5.86) |
Shares used in computing net income attributable to Common Shareholders per share, basic (in shares) | 7,356,952 | 7,319,279 | 7,338,853 | 7,385,348 | 5,993,013 |
Income allocated to participating securities | $ (7,508) | $ (6,618) | $ (5,975) | $ (5,227) | $ 0 |
Net income attributable to Common Shareholders, diluted | $ 63,155 | $ 55,371 | $ 49,078 | $ 42,342 | $ (35,099) |
Net income attributable to Common Shareholders per share, diluted (in dollars per share) | $ 8.58 | $ 7.56 | $ 6.68 | $ 5.72 | $ (5.86) |
Shares used in computing net income attributable to Common Shareholders per share, diluted (in shares) | 7,360,453 | 7,321,022 | 7,345,954 | 7,406,986 | 5,993,013 |
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | $ (186) | $ (186) | $ 0 | ||
Previously Reported [Member] | |||||
Net income | $ 70,663 | $ 61,989 | 55,239 | ||
Income allocated to participating securities | 0 | 0 | (129) | ||
Net income attributable to Common Shareholders, basic | $ 70,663 | $ 61,989 | $ 54,924 | ||
Net income attributable to Common Shareholders per share, basic (in dollars per share) | $ 9.60 | $ 8.47 | $ 7.48 | ||
Shares used in computing net income attributable to Common Shareholders per share, basic (in shares) | 7,356,952 | 7,319,279 | 7,338,853 | ||
Income allocated to participating securities | $ 0 | $ 0 | $ (129) | ||
Net income attributable to Common Shareholders, diluted | $ 70,663 | $ 61,989 | $ 54,924 | ||
Net income attributable to Common Shareholders per share, diluted (in dollars per share) | $ 9.60 | $ 8.47 | $ 7.46 | ||
Shares used in computing net income attributable to Common Shareholders per share, diluted (in shares) | 7,360,453 | 7,321,022 | 7,367,293 | ||
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | $ (186) | ||||
Revision of Prior Period, Adjustment [Member] | |||||
Net income | $ 0 | $ 0 | 0 | ||
Income allocated to participating securities | (7,511) | (6,619) | (5,851) | ||
Net income attributable to Common Shareholders, basic | $ (7,511) | $ (6,619) | $ (5,851) | ||
Net income attributable to Common Shareholders per share, basic (in dollars per share) | $ (1.02) | $ (0.91) | $ (0.79) | ||
Shares used in computing net income attributable to Common Shareholders per share, basic (in shares) | 0 | 0 | 0 | ||
Income allocated to participating securities | $ (7,508) | $ (6,618) | $ (5,846) | ||
Net income attributable to Common Shareholders, diluted | $ (7,508) | $ (6,618) | $ (5,846) | ||
Net income attributable to Common Shareholders per share, diluted (in dollars per share) | $ (1.02) | $ (0.91) | $ (0.78) | ||
Shares used in computing net income attributable to Common Shareholders per share, diluted (in shares) | 0 | 0 | (21,339) | ||
Deemed dividend related to Series A Redeemable Convertible Preferred Stock | $ 0 |
Schedule II - Valuation and Q_3
Schedule II - Valuation and Qualifying Accounts - Valuation and Qualifying Accounts (Details) - SEC Schedule, 12-09, Allowance, Sales and Returns, Discounts, Chargebacks and Rebates [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | ||
Balance | $ 780 | $ 668 | |
Additions | 521 | 1,012 | |
Deductions | (977) | (900) | [1] |
Balance | $ 324 | $ 780 | |
[1]Deductions to sales discounts and allowances relate to discounts or allowances actually taken or paid. |