Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 02, 2024 | |
Document Information [Line Items] | ||
Entity Central Index Key | 0001267602 | |
Entity Registrant Name | ALIMERA SCIENCES INC | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2024 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-34703 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-0028718 | |
Entity Address, Address Line One | 6310 Town Square, Suite 400 | |
Entity Address, City or Town | Alpharetta | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30005 | |
City Area Code | 678 | |
Local Phone Number | 990-5740 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | ALIM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 54,384,165 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 10,828 | $ 12,058 |
Restricted cash | 33 | 32 |
Accounts receivable, net | 37,079 | 34,545 |
Prepaid expenses and other current assets | 4,013 | 3,909 |
Inventory | 3,455 | 1,879 |
Total current assets | 55,408 | 52,423 |
Property and equipment, net | 2,278 | 2,466 |
Right-of-use assets, net | 996 | 1,124 |
Intangible assets, net | 91,587 | 97,355 |
Deferred tax asset | 101 | 104 |
Warrant asset | 7 | 52 |
Total assets | 150,377 | 153,524 |
Current liabilities: | ||
Accounts payable | 10,208 | 8,252 |
Accrued expenses | 5,708 | 6,192 |
Accrued licensor payment | 3,677 | 7,275 |
Finance lease obligations | 245 | 194 |
Total current liabilities | 19,838 | 21,913 |
Non-current liabilities: | ||
Notes payable, net of discount | 69,731 | 64,489 |
Accrued licensor payments | 16,111 | 15,136 |
Other non-current liabilities | 5,909 | 5,816 |
Total liabilities | 111,589 | 107,354 |
Commitments and contingencies (note 8) | ||
Stockholders’ equity: | ||
Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2024 and December 31, 2023, none issued | 0 | 0 |
Common stock, $.01 par value — 150,000,000 shares authorized, 52,387,763 shares issued and outstanding at June 30, 2024 and 52,354,450 shares issued and outstanding at December 31, 2023 | 524 | 524 |
Common stock warrants | 4,396 | 4,396 |
Additional paid-in capital | 464,825 | 462,446 |
Accumulated deficit | (428,052) | (418,490) |
Accumulated other comprehensive loss | (2,905) | (2,706) |
Total stockholders’ equity | 38,788 | 46,170 |
Total liabilities and stockholders’ equity | $ 150,377 | $ 153,524 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, issued (in shares) | 52,387,763 | 52,354,450 |
Common stock, outstanding (in shares) | 52,387,763 | 52,354,450 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net revenue | $ 27,000 | $ 17,538 | $ 50,011 | $ 31,084 |
Cost of goods sold, excluding depreciation and amortization | (3,831) | (2,425) | (7,184) | (4,453) |
Gross profit | 23,169 | 15,113 | 42,827 | 26,631 |
Operating expenses: | ||||
Research, development and medical affairs expenses | 4,263 | 3,648 | 8,624 | 7,812 |
General and administrative expenses | 7,379 | 4,373 | 12,811 | 8,544 |
Sales and marketing expenses | 8,511 | 6,434 | 17,593 | 12,238 |
Depreciation and amortization | 3,093 | 1,866 | 6,178 | 2,547 |
Total operating expenses | 23,246 | 16,321 | 45,206 | 31,141 |
Segment income (loss) from operations | (77) | (1,208) | (2,379) | (4,510) |
Interest expense and other, net | (3,153) | (1,694) | (6,892) | (3,361) |
Unrealized foreign currency loss, net | (125) | (7) | (321) | (20) |
Loss on extinguishment of debt | 0 | (1,079) | 0 | (1,079) |
Change in fair value of common stock warrant | 0 | (5,911) | 0 | (5,911) |
Change in fair value of warrant asset | 1 | (105) | (45) | (91) |
Net loss before taxes | (3,354) | (10,004) | (9,637) | (14,972) |
Income tax benefit (provision) | 43 | (25) | 75 | (25) |
Net loss | (3,311) | (10,029) | (9,562) | (14,997) |
Preferred stock dividends | 0 | (669) | 0 | (683) |
Net loss applicable to common stockholders | $ (3,311) | $ (10,698) | $ (9,562) | $ (15,680) |
Net loss per share — basic and diluted (in dollars per share) | $ (0.06) | $ (1.32) | $ (0.18) | $ (2.07) |
Weighted average shares outstanding — basic and diluted (in shares) | 54,383,604 | 8,093,640 | 54,370,216 | 7,565,868 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive (Loss) Income (Unuadited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net loss | $ (3,311) | $ (10,029) | $ (9,562) | $ (14,997) |
Other comprehensive (loss) income: | ||||
Foreign currency translation adjustments | (51) | 0 | (199) | 172 |
Total other comprehensive (loss) income | (51) | 0 | (199) | 172 |
Comprehensive loss | $ (3,362) | $ (10,029) | $ (9,761) | $ (14,825) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (9,562) | $ (14,997) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 6,178 | 2,547 |
Loss on extinguishment of debt | 0 | 1,079 |
Provision for credit losses | 176 | 1,496 |
Unrealized foreign currency transaction loss, net | 321 | 20 |
Amortization of debt discount and deferred financing costs | 542 | 488 |
Stock-based compensation expense | 2,302 | 442 |
Change in fair value of warrant asset | 45 | 91 |
Change in fair value of warrant liability | 0 | 5,911 |
Changes in assets and liabilities: | ||
Accounts receivable | (3,028) | (4,355) |
Prepaid expenses and other current assets | (59) | (539) |
Inventory | (1,588) | 559 |
Accounts payable | 4,445 | (2,066) |
Accrued expenses and other current liabilities | (287) | 202 |
Other non-current liabilities | 975 | 917 |
Net cash provided by (used in) operating activities | 460 | (8,205) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (132) | (171) |
Purchase of intangible assets | 0 | (75,272) |
Net cash used in investing activities | (132) | (75,443) |
Cash flows from financing activities: | ||
Repurchase of Series A Preferred Stock | 0 | (938) |
Proceeds from issuance of Series B Convertible Preferred Stock | 0 | 78,339 |
Series B Convertible Preferred Stock issuance costs | 0 | (509) |
Proceeds from issuance of common stock | 40 | 2,404 |
Proceeds from exercise of stock options | 37 | 0 |
Repurchase of common stock | 0 | (314) |
Issuance of debt | 5,000 | 22,500 |
Payment of debt costs | (62) | (4,108) |
Payment of accrued licensor obligations | (3,750) | 0 |
Payment of SLR exit fee agreements | (2,425) | 0 |
Payment of finance lease obligations | (188) | (251) |
Net cash (used in) provided by financing activities | (1,348) | 97,123 |
Effect of exchange rates on cash and cash equivalents and restricted cash | (209) | 28 |
Net change in cash and cash equivalents and restricted cash | (1,229) | 13,503 |
Cash and cash equivalents and restricted cash — beginning of period | 12,090 | 5,304 |
Cash and cash equivalents and restricted cash — end of period | 10,861 | 18,807 |
Supplemental cash flow information: | ||
Cash paid for interest | 3,723 | 3,136 |
Cash paid for income taxes | 21 | 21 |
Supplemental noncash investing and financing activities: | ||
Note payable end of term payment accrued but unpaid | $ 3,625 | $ 3,375 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands | Repurchase of Series A Preferred Stock [Member] Common Stock [Member] | Repurchase of Series A Preferred Stock [Member] Preferred Stock [Member] Series A Preferred Stock [Member] | Repurchase of Series A Preferred Stock [Member] Preferred Stock [Member] Series B Preferred Stock [Member] | Repurchase of Series A Preferred Stock [Member] Additional Paid-in Capital [Member] | Repurchase of Series A Preferred Stock [Member] Common Stock Warrants [Member] | Repurchase of Series A Preferred Stock [Member] Retained Earnings [Member] | Repurchase of Series A Preferred Stock [Member] AOCI Attributable to Parent [Member] | Repurchase of Series A Preferred Stock [Member] | Issuance of Series B Preferred Stock [Member] Common Stock [Member] | Issuance of Series B Preferred Stock [Member] Preferred Stock [Member] Series A Preferred Stock [Member] | Issuance of Series B Preferred Stock [Member] Preferred Stock [Member] Series B Preferred Stock [Member] | Issuance of Series B Preferred Stock [Member] Additional Paid-in Capital [Member] | Issuance of Series B Preferred Stock [Member] Common Stock Warrants [Member] | Issuance of Series B Preferred Stock [Member] Retained Earnings [Member] | Issuance of Series B Preferred Stock [Member] AOCI Attributable to Parent [Member] | Issuance of Series B Preferred Stock [Member] | Common Stock [Member] | Preferred Stock [Member] Series A Preferred Stock [Member] | Preferred Stock [Member] Series B Preferred Stock [Member] | Additional Paid-in Capital [Member] | Common Stock Warrants [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Balance (in shares) at Dec. 31, 2022 | 6,995,513 | 600,000 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 70 | $ 19,227 | $ 0 | $ 378,238 | $ 0 | $ (415,388) | $ (2,955) | $ (20,808) | ||||||||||||||||
Issuance of Stock (in shares) | 0 | 0 | 12,000 | 597,000 | 0 | 0 | ||||||||||||||||||
Issuance of Stock | $ 0 | $ 0 | $ 7,714 | $ 0 | $ 0 | $ 0 | $ 0 | $ 7,714 | $ 6 | $ 0 | $ 0 | 0 | 0 | 0 | 0 | |||||||||
Issuance of Stock | (6) | |||||||||||||||||||||||
Repurchase of stock (in shares) | 0 | (600,000) | 0 | (200,919) | 0 | 0 | ||||||||||||||||||
Repurchase of stock | $ 0 | $ (19,227) | $ 0 | $ 0 | $ 0 | $ 0 | $ (938) | $ (2) | $ 0 | $ 0 | (312) | 0 | 0 | (314) | ||||||||||
Repurchase of Preferred Stock - Series A | $ 18,289 | |||||||||||||||||||||||
Preferred stock dividends | 0 | 0 | 14 | |||||||||||||||||||||
Preferred stock dividends | 0 | 0 | (14) | 0 | 0 | |||||||||||||||||||
Stock-based compensation expense | 0 | 0 | 0 | 226 | 0 | 0 | 0 | 226 | ||||||||||||||||
Net loss | 0 | 0 | 0 | 0 | 0 | (4,968) | 0 | (4,968) | ||||||||||||||||
Foreign currency translation adjustments | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | 172 | 172 | ||||||||||||||||
Balance (in shares) at Mar. 31, 2023 | 7,391,594 | 0 | 12,000 | |||||||||||||||||||||
Balance at Mar. 31, 2023 | $ 74 | $ 0 | $ 7,728 | 378,146 | 0 | (402,081) | (2,783) | (18,916) | ||||||||||||||||
Balance (in shares) at Dec. 31, 2022 | 6,995,513 | 600,000 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2022 | $ 70 | $ 19,227 | $ 0 | 378,238 | 0 | (415,388) | (2,955) | (20,808) | ||||||||||||||||
Net loss | (14,997) | |||||||||||||||||||||||
Foreign currency translation adjustments | $ 172 | |||||||||||||||||||||||
Stock option exercises (in shares) | 0 | |||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2023 | 8,803,727 | 0 | 78,617 | |||||||||||||||||||||
Balance at Jun. 30, 2023 | $ 88 | $ 0 | $ 74,725 | 386,979 | 0 | (412,779) | (2,783) | $ 46,230 | ||||||||||||||||
Balance (in shares) at Mar. 31, 2023 | 7,391,594 | 0 | 12,000 | |||||||||||||||||||||
Balance at Mar. 31, 2023 | $ 74 | $ 0 | $ 7,728 | 378,146 | 0 | (402,081) | (2,783) | (18,916) | ||||||||||||||||
Issuance of Stock (in shares) | 0 | 0 | 66,617 | 1,415,133 | 0 | 0 | ||||||||||||||||||
Issuance of Stock | $ 0 | $ 0 | $ 66,328 | $ 2,355 | $ 0 | $ 0 | $ 68,683 | $ 14 | $ 0 | $ 0 | 34 | 0 | 0 | 0 | 48 | |||||||||
Issuance of Stock | 0 | (669) | 0 | 0 | ||||||||||||||||||||
Preferred stock dividends | 0 | 0 | 669 | |||||||||||||||||||||
Stock-based compensation expense | 0 | 0 | 0 | 217 | 0 | 0 | 0 | 217 | ||||||||||||||||
Net loss | $ 0 | $ 0 | $ 0 | 0 | 0 | (10,029) | 0 | (10,029) | ||||||||||||||||
Foreign currency translation adjustments | 0 | |||||||||||||||||||||||
Forfeitures of restricted stock (in shares) | (3,000) | 0 | 0 | |||||||||||||||||||||
Forfeitures of restricted stock | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||
Forfeiture of common stock warrants | $ 0 | $ 0 | $ 0 | 6,227 | 0 | 0 | $ 6,227 | |||||||||||||||||
Stock option exercises (in shares) | 0 | |||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2023 | 8,803,727 | 0 | 78,617 | |||||||||||||||||||||
Balance at Jun. 30, 2023 | $ 88 | $ 0 | $ 74,725 | 386,979 | 0 | (412,779) | (2,783) | $ 46,230 | ||||||||||||||||
Balance (in shares) at Dec. 31, 2023 | 52,354,450 | 0 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2023 | $ 524 | $ 0 | $ 0 | 462,446 | 4,396 | (418,490) | (2,706) | 46,170 | ||||||||||||||||
Issuance of Stock (in shares) | 7,112 | 0 | 0 | |||||||||||||||||||||
Issuance of Stock | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||
Stock-based compensation expense | 0 | 0 | 0 | 845 | 0 | 0 | 0 | 845 | ||||||||||||||||
Net loss | 0 | 0 | 0 | 0 | 0 | (6,251) | 0 | (6,251) | ||||||||||||||||
Foreign currency translation adjustments | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | (148) | (148) | ||||||||||||||||
Stock option exercises (in shares) | 13,125 | 0 | 0 | |||||||||||||||||||||
Stock option exercises | $ 0 | $ 0 | $ 0 | 37 | 0 | 0 | 0 | 37 | ||||||||||||||||
Balance (in shares) at Mar. 31, 2024 | 52,374,687 | 0 | 0 | |||||||||||||||||||||
Balance at Mar. 31, 2024 | $ 524 | $ 0 | $ 0 | 463,328 | 4,396 | (424,741) | (2,854) | 40,653 | ||||||||||||||||
Balance (in shares) at Dec. 31, 2023 | 52,354,450 | 0 | 0 | |||||||||||||||||||||
Balance at Dec. 31, 2023 | $ 524 | $ 0 | $ 0 | 462,446 | 4,396 | (418,490) | (2,706) | 46,170 | ||||||||||||||||
Net loss | (9,562) | |||||||||||||||||||||||
Foreign currency translation adjustments | $ (199) | |||||||||||||||||||||||
Stock option exercises (in shares) | 13,125 | |||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2024 | 52,387,763 | 0 | 0 | |||||||||||||||||||||
Balance at Jun. 30, 2024 | $ 524 | $ 0 | $ 0 | 464,825 | 4,396 | (428,052) | (2,905) | $ 38,788 | ||||||||||||||||
Balance (in shares) at Mar. 31, 2024 | 52,374,687 | 0 | 0 | |||||||||||||||||||||
Balance at Mar. 31, 2024 | $ 524 | $ 0 | $ 0 | 463,328 | 4,396 | (424,741) | (2,854) | 40,653 | ||||||||||||||||
Issuance of Stock (in shares) | 13,826 | 0 | 0 | |||||||||||||||||||||
Issuance of Stock | $ 0 | $ 0 | $ 0 | 40 | 0 | 0 | 0 | 40 | ||||||||||||||||
Stock-based compensation expense | 0 | 0 | 0 | 1,457 | 0 | 0 | 0 | 1,457 | ||||||||||||||||
Net loss | 0 | 0 | 0 | 0 | 0 | (3,311) | 0 | (3,311) | ||||||||||||||||
Foreign currency translation adjustments | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | (51) | (51) | ||||||||||||||||
Forfeitures of restricted stock (in shares) | (750) | 0 | 0 | |||||||||||||||||||||
Forfeitures of restricted stock | $ 0 | $ 0 | $ 0 | 0 | 0 | 0 | 0 | $ 0 | ||||||||||||||||
Stock option exercises (in shares) | 0 | |||||||||||||||||||||||
Balance (in shares) at Jun. 30, 2024 | 52,387,763 | 0 | 0 | |||||||||||||||||||||
Balance at Jun. 30, 2024 | $ 524 | $ 0 | $ 0 | $ 464,825 | $ 4,396 | $ (428,052) | $ (2,905) | $ 38,788 |
Note 1 - Nature of Operations
Note 1 - Nature of Operations | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Nature of Operations [Text Block] | 1. Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the “Company”), is a global pharmaceutical company that specializes in the commercialization and development of ophthalmic retinal pharmaceuticals. The Company was formed on June 4, 2003, The Company presently focuses on diseases affecting the retina, because the Company believes these diseases are not ® 0.19 ® 0.18 In the U.S. and certain other countries outside Europe, ILUVIEN is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not The Company markets ILUVIEN directly in the U.S., Germany, the United Kingdom (“U.K.”), Portugal and Ireland. In addition, the Company has entered into various agreements under which distributors are providing or will provide regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Switzerland, Australia, New Zealand and several countries in the Middle East. In addition, the Company has granted an exclusive license to Ocumension Therapeutics (“Ocumension”) for the development and commercialization of the Company’s 0.19 June 30, 2024 In the U.S., YUTIQ is indicated for the treatment and prevention of chronic NIU-PS of the eye. The Company has the rights to commercialize YUTIQ under a product rights agreement dated May 17, 2023 ( 4 Agreement and Plan of Merger with ANI Pharmaceuticals, Inc. and ANIP Merger Sub INC. On June 21, 2024, may Consummation of the Merger is subject to customary closing conditions, including, without limitation, the absence of certain legal impediments, the expiration or termination of the required waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, no Consummation of the Merger by the Company is further subject to satisfaction of customary closing conditions on the part of ANI and the Merger Subsidiary, including, without limitation, ANI and Merger Subsidiary having performed, or complied with, in all material respects all of their respective agreements, covenants and obligations required to be performed or complied with by each of them under the Merger Agreement at or prior to the Closing Date, the representations and warranties of ANI and Merger Subsidiary being true and correct (subject in certain instances to materiality qualifiers as specified within the respective agreement), and the CVR Agreement being in full force and effect. The Merger Agreement includes covenants requiring the Company not third 203 third The Merger Agreement requires the Company, as promptly as reasonably practicable, and in any event within 25 business days following the date of the Merger Agreement, to prepare and file with the U.S. Securities and Exchange Commission (the “SEC”) a proxy statement for the purpose of seeking stockholder approval to the Merger Agreement. To satisfy this requirement, the Company completed a PREM14A July 24, 2024. The Merger Agreement contains certain termination rights for the Company and ANI. Upon termination of the Merger Agreement under specified circumstances, the Company will be required to pay ANI a termination fee of approximately $10.4 million. Among other termination rights, and subject to certain limitations, (i) either the Company or ANI may not December 21, 2024 may At the Effective Time, outstanding awards of restricted stock with respect to shares of Company Common Stock (each, a “Company RSA”), whether vested or unvested as of immediately prior to the Effective Time, for which the holder thereof made a timely and valid election (an “83 83 1986, not 83 At the Effective Time, each stock option granted by the Company to purchase Company Common Stock (each, a “Company Option”) that is outstanding and unvested immediately prior to the Effective Time will vest in full, and (i) each Company Option that is then outstanding and unexercised and which has a per share exercise price that is less than the Closing Cash Consideration shall be canceled and converted into the right to receive the sum of an amount in cash (without interest and subject to deduction for any required withholding as contemplated in the Merger Agreement) equal to: (a) the excess, if any, of the Closing Cash Consideration over the exercise price per share of such Company Option; multiplied by the number of shares of Company Common Stock underlying such Company Option and (b) one 1 no At the Effective Time, each Company performance stock unit (“Company PSU”) that is then outstanding shall automatically be canceled and converted into the right to receive (i) from the Surviving Corporation an amount of cash equal to the product of (A) the total number of shares of Company Common Stock then underlying such Company PSUs pursuant to the applicable Company PSU grant terms, with, for the avoidance of doubt, all performance metrics deemed achieved at 100%, multiplied by (B) the Closing Cash Consideration, without any interest thereon and (ii) CVRs in an amount equal to the total number of shares of Company Common Stock then underlying such Company PSUs pursuant to the applicable Company PSU grant terms, with, for the avoidance of doubt, all performance metrics deemed achieved at 100%. At the Effective Time, each Company restricted stock unit (“Company RSU”) that is then outstanding shall automatically be canceled and converted into the right to receive (i) from the Surviving Corporation an amount of cash equal to the product of (A) the number of shares of Company Common Stock then underlying such Company RSU multiplied by (B) the Closing Cash Consideration, without any interest thereon and (ii) CVRs in an amount equal to the total number of shares of Company Common Stock then underlying such Company RSUs. At the Effective Time, each Company warrant (“Company Warrant”) that is outstanding as of immediately prior to the Effective Time shall, upon the Effective Time, convert into the right to receive, upon exercise of such Company Warrant, the same Merger Consideration as such holder would have been entitled to receive following the Effective Time if such holder had been, immediately prior to the Effective Time, the holder of the number of shares of Company Common Stock then issuable upon exercise in full of such Company Warrant without regard to any limitations on exercise contained therein. Voting Agreement In connection with the execution of the Merger Agreement, ANI and the Company entered into a voting agreement (the “Voting Agreement”) with Caligan Partners LP, Caligan Partners Master Fund LP and Caligan Partners CV VI LP (collectively, “Caligan”). Pursuant to the Voting Agreement, Caligan has agreed, among other things, to (i) vote or cause to be voted all of its shares of Company Common Stock in favor of the Merger and the transactions contemplated by the Merger Agreement and (ii) prior to the Expiration Time (as defined in the Voting Agreement) and subject to limited exceptions, not July 31, 2024. Contingent Value Rights Agreement At or immediately prior to the Effective Time, ANI will enter into a contingent value rights agreement (the “CVR Agreement”) with a rights agent (the “Rights Agent”), pursuant to which each holder of Company Common Stock, as well as holders of Company Warrants, Company Options, Company PSUs, Company RSAs and Company RSUs, may “2026 third 2026 “2026 “2027 2026 third 2027 “2027 When issued, each CVR will entitle the holder (the “Holder”) to receive a Milestone Payment upon satisfaction of the applicable Milestones. The Milestone Payment for each CVR will equal the product (rounded to the nearest 1/100 not one 2026 not one 2027 If a Milestone is attained, the distributions in respect of the CVRs will be made on or prior to the date that is fifteen 10 not Under the CVR Agreement, the Rights Agent will have, and Holders of at least 35% of the CVRs then-outstanding have, certain rights to audit and enforcement on behalf of all Holders of the CVRs. ANI will undertake under the terms of the CVR Agreement to use diligent efforts to achieve the Milestones, as such efforts are further described in the CVR Agreement.' Costs incurred associated with the Merger Agreement totaled $2.2 million for both the three six June 30, 2024 |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Basis of Accounting [Text Block] | 2. The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (“Interim Financial Statements”) in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”) for interim financial information and with the instructions to Form 10 8 03 X not The accompanying Interim Financial Statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2023 10 December 31, 2023 March 8, 2024 2023 10 not As of June 30, 2024 December 31, 2023 12 |
Note 3 - Summary of Significant
Note 3 - Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Significant Accounting Policies [Text Block] | 3. The accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the 2023 10 Acquisition of Intangible Assets The Company accounts for the acquisition of pharmaceutical product licenses as an asset acquisition in accordance with Business Combinations (Topic 805 Accounting for Contract Assets and Contract Liabilities from Contracts with Customers 805” 805 not Foreign Currency Translation The financial statements of each of the Company’s subsidiaries with a functional currency other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. Foreign currency transaction gains and losses are included in other (expense) income, net in the results of operations. Adoption of New Accounting Standards In June 2022, No. 2022 03, Fair Value Measurement (Topic 820 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions not not January 1, 2024. not In November 2023, No. 2023 07, Segment Reporting (Topic 280 Improvements to Reportable Segment Disclosures December 15, 2023, December 15, 2024. January 1, 2024. not Accounting Standards Issued but Not In March 2020, 2020 04, Reference Rate Reform (Topic 848 2020 04” December 31, 2022. December 2022, No. 2022 06, Reference Rate Reform (Topic 848 848, 2020 04. 2020 04 may 2020 04 December 31, 2022, December 31, 2024. not In October 2023, No. 2023 06, Disclosure Improvements: Codification Amendments in Response to the SEC s Disclosure Update and Simplification Initiative 2023 06” 2023 06 X 2023 06 In December 2023, 2023 09, Income Taxes (Topic 740 2023 09” 2023 09 2023 09 January 1, 2025. 2023 09 |
Note 4 - Revenue Recognition
Note 4 - Revenue Recognition | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Revenue from Contract with Customer [Text Block] | 4. Overview The Company recognizes revenue when a customer obtains control of the related good or service pursuant to ASC 606, Revenue from Contracts with Customers 606, 1 2 3 4 5 606, If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not Product Revenue The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its “Customer(s)”). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Estimates of Variable Consideration Revenues from product sales are recorded at the transaction price, which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations, Group Purchasing Organizations, distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not may With respect to the Company’s international contracts with third Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three one may, not The estimation process for product returns involves, in each case, several interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may no Collaboration and License Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these agreements may one Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not The Company will recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606. not Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 120 not one Accounts Receivable, net Accounts receivable are generated through sales primarily to major pharmaceutical distributors, pharmacies, hospitals and wholesalers. The Company does not not may The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. As of June 30, 2024 2023 three June 30, 2024 2023 Allowance for credit losses consisted of the following for the three six June 30, 2024 2023 Three Months Ended June 30, 2024 2023 (In thousands) Beginning balance $ 186 $ 185 Provision for credit losses — 625 Write-off of bad debt — (625 ) Ending Balance $ 186 $ 185 For the Six Months Ended June 30, 2024 2023 (In thousands) Beginning balance $ 1,222 $ — Provision for credit losses 176 1,496 Write-off of bad debt (1,212 ) (1,311 ) Ending Balance $ 186 $ 185 |
Note 5 - Leases
Note 5 - Leases | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Leases [Text Block] | 5. The Company evaluates all of its contracts to determine whether it is or contains a lease component under FASB ASC 842 Leases 842” 842, three not not 12 not Lease renewal options are not not not Operating Leases The Company’s operating lease activities primarily consist of leases for office space in the U.S., the U.K., and Ireland. Most of these leases include options to renew, with renewal terms generally ranging from one eight not Supplemental balance sheet information as of June 30, 2024 December 31, 2023 June 30, December 31, 2024 2023 (In thousands) Non-current assets: Right-of-use assets, net $ 996 $ 1,124 Total lease assets $ 996 $ 1,124 Current liabilities: Accrued expenses $ 535 $ 634 Non-current liabilities: Other non-current liabilities 1,691 1,826 Total lease liabilities $ 2,226 $ 2,460 The Company’s operating lease cost for the three six June 30, 2024 three six June 30, 2023 As of June 30, 2024 Years Ending December 31 (In thousands) 2024 (remaining) $ 319 2025 474 2026 488 2027 503 2028 518 Thereafter 534 Total 2,836 Less amount representing interest (610 ) Present value of minimum lease payments 2,226 Less current portion (as a portion of accrued expenses) (535 ) Non-current portion (as a portion of other non-current liabilities) $ 1,691 For the three June 30, 2024 2023, six June 30, 2024 2023, three six June 30, 2024 2023 As of June 30, 2024 Finance Leases The Company’s finance lease activities primarily consist of leases for automobiles. Property and equipment leases are capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not Supplemental balance sheet information as of June 30, 2024 December 31, 2023 June 30, December 31, 2024 2023 (In thousands) Non-current assets: Property and equipment, net $ 589 $ 554 Total lease assets $ 589 $ 554 Current liabilities: Finance lease obligations $ 245 $ 194 Non-current liabilities: Finance lease obligations - less current portion 244 256 Total lease liabilities $ 489 $ 450 Depreciation expense associated with property and equipment under finance leases was $0.1 million for both the three June 30, 2024 2023 six June 30, 2024 2023 three June 30, 2024 2023 six June 30, 2024 2023 As of June 30, 2024 Years Ending December 31 (In thousands) 2024 (remaining) $ 195 2025 284 2026 182 2027 13 Total 674 Less amount representing interest (185 ) Present value of minimum lease payments 489 Less current portion (245 ) Non-current portion $ 244 Cash paid for finance leases was $0.1 million during both of the three June 30, 2024 2023. six June 30, 2024 2023, three June 30, 2024 2023. six June 30, 2024 2023, As of June 30, 2024 |
Note 6 - Inventory
Note 6 - Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Inventory Disclosure [Text Block] | 6. Inventories are stated at the lower of cost or net realizable value with cost determined under the first first third not As of June 30, 2024 December 31, 2023 June 30, December 31, 2024 2023 (In thousands) Component parts (1) $ 653 $ 688 Work-in-process (2) 308 134 Finished goods 2,494 1,057 Total Inventory $ 3,455 $ 1,879 ( 1 Component parts inventory consists of manufactured components of the ILUVIEN applicator. ( 2 Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not |
Note 7 - Intangible Assets
Note 7 - Intangible Assets | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Intangible Assets Disclosure [Text Block] | 7. ILUVIEN Intangible Asset As a result of the U.S. Food and Drug Administration’s approval of ILUVIEN in September 2014, October 2014 ( 8 The gross carrying amount of the ILUVIEN intangible asset is $25.0 million, which is being amortized over approximately 13 years from the acquisition date. The amortization expense related to the ILUVIEN intangible asset was approximately $0.5 million for the three June 30, 2024 2023 six June 30, 2024 2023 June 30, 2024 December 31, 2023 The estimated remaining amortization of the ILUVIEN intangible asset as of June 30, 2024 Years Ending December 31 (In thousands) 2024 (remaining) $ 978 2025 1,940 2026 1,940 2027 1,191 Total $ 6,049 YUTIQ Intangible Asset On May 17, 2023, two six June 30, 2024 two December 31, 2024. 2025 2028 8 2024 2025 2028 As of June 30, 2024 June 30, 2024 December 31, 2023 three June 30, 2024 2023 six June 30, 2024 2023 The estimated remaining amortization of the YUTIQ intangible asset as of June 30, 2024 Years Ending December 31 (In thousands) 2024 (remaining) $ 4,853 2025 9,627 2026 9,627 2027 9,627 2028 9,654 Thereafter 42,150 Total $ 85,538 |
Note 8 - License Agreements
Note 8 - License Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Collaborative Arrangement Disclosure [Text Block] | 8. EyePoint Agreements In February 2005, On July 10, 2017, July 1, 2017. December 12, 2018. On May 17, 2023, four 2024. 2025 2028 2025, 2024, June 30, 2024 second 2024 2025 2028 Concurrently in May 2023, two May 2025 one The Company’s license rights to EyePoint’s proprietary delivery device could revert to EyePoint if the Company were to: (i) fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the EyePoint Agreement within 30 90 may 30 60 In connection with a previous agreement with EyePoint, the Company was entitled to recover commercialization costs that were incurred prior to profitability of ILUVIEN and offset a portion of future payments owed to EyePoint in connection with sales of ILUVIEN with those accumulated commercialization costs, referred to as the “Future Offset.” Following the signing of the New Collaboration Agreement, the Company retained the right to recover up to $15.0 million of the Future Offset. In March 2019, June 30, 2024 December 31, 2023 SWK Agreements On December 17, 2020, not On June 19, 2024, may, six 6 x four April 1, 2025, four If the Company or SWK were to default under the Letter Agreement, the Company would be required to revert to making royalty payments under the New Collaboration agreement in lieu of the Alternative Royalty. Royalty Expense For the three June 30, 2024 2023, six June 30, 2024 2023, June 30, 2024 2023 Ocumension License Agreement On April 14, 2021, third 190 The Company received a nonrefundable upfront payment of $10.0 million from Ocumension HK and may may The term of the License Agreement will continue (a) until the 10th first 10th not first not As of June 30, 2024 December 31, 2023 Warrant Subscription Agreement On April 14, 2021, four HK$23.88 US$3.07 April 9, 2021 HK$23.88 August 13, 2021, April 14, 2025. not not |
Note 9 - Loan Agreements
Note 9 - Loan Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Debt Disclosure [Text Block] | 9. Loan Agreements with SLR Investment Corp. (formerly Solar Capital Ltd.) On January 5, 2018, “2018 “2018 On December 31, 2019, 2018 “2019 “2019 2019 2019 ● On February 22, 2022, 2019 six ● On December 7, 2022, 2019 January 1, 2023 April 1, 2023, July 1, 2023 first 2023. ● On March 24, 2023, 2019 “2023 March 31, 2023. ● On May 17, 2023, 2019 June 30, 2023. ● On March 6, 2024, 2019 March 6, 2024. Interest on the 2019 one LIBOR 2019 one SOFR June 30, 2024 December 31, 2023 2019 2019 April 30, 2025, may 12 April 20, 2025, April 30, 2028. December 31, 2023 no April 20, 2025, 12 The Company is in compliance with the Revenue Covenant, and expects to comply with the remainder of the Revenue Covenant through one Exit Fee Agreements 2018 Pursuant to the existing 2018 2018 2019 not ● First, if the Company achieves revenues of $80.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third 12 ● Second, if the Company achieves revenues of $100.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third 2019 Pursuant to the existing 2019 2019 2019 not ● First, if the Company achieves revenues of $75.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third 12 ● Second, if the Company achieves revenues of $95.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third 2023 Pursuant to the existing 2023 2019 2019 not 2019 2019 ● If the Company achieves revenues of $82.5 million or more from the sale of its ILUVIEN product in the ordinary course of business to third 12 On May 17, 2023, three third not During the fourth 2023, one 2018 one 2019 fourth 2023. first 2024, 2023 second 2024, one 2019 June 30, 2024 June 30, 2024, one 2018 Modification of Debt The Company capitalized approximately $2.6 million of deferred financing costs in connection with the Fifth and Sixth Amendments during 2023. Extinguishment of Debt In accordance with the guidance in ASC Subtopic 470 50, Debt Modifications and Extinguishments Fair Value of Debt The weighted average interest rates of the Company’s notes payable approximate the rate at which the Company could obtain alternative financing. Therefore, the carrying amount of the notes approximated their fair value at June 30, 2024 December 31, 2023 |
Note 10 - Earnings (Loss) Per S
Note 10 - Earnings (Loss) Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Earnings Per Share [Text Block] | 10. The Company follows ASC 260, Earnings Per Share 260” two not 2023 11 Basic net loss per share is calculated by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. For purposes of the diluted net loss per share calculation, stock options, unvested restricted stock units and Employee Stock Purchase Plan (“ESPP”) shares are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share were the same for all periods presented as a result of the Company’s net loss. The following common stock equivalents were excluded from the computation of diluted net loss per share for the three six June 30, 2024 2023 June 30, 2024 2023 Series B convertible preferred stock — 45,272,874 Common stock warrants 1,600,000 1,600,000 Stock options 3,275,893 1,217,045 Restricted stock units (“RSUs”) 869,638 — Performance stock units (“PSUs”) 900,000 — Total 6,645,531 48,089,919 |
Note 11 - Stockholders' Equity
Note 11 - Stockholders' Equity (Deficit) | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Equity [Text Block] | 11. EQUITY Series A Convertible Preferred Stock In October 2012, October 1, 2017) 2014, 2023, Series B Convertible Preferred Stock In March 2023, May 2023, August 1, 2023, 2023 August 1, 2023, August 15, 2023, In August 2024, Common and Preferred Stock The Company’s authorized capital stock consists of (a) 150,000,000 shares of common stock, par value $0.01 per share; and (b) 10,000,000 shares of preferred stock, par value $0.01 per share. At June 30, 2024 December 31, 2023 June 30, 2024 December 31, 2023 |
Note 12 - Stock-based Compensat
Note 12 - Stock-based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Share-Based Payment Arrangement [Text Block] | 12. 2023 On August 1, 2023, 2023 “2023 2019 “2019 2023 2019 August 1, 2023 ( 2019 not 2019 first may 2023 2023 2019 2010 no not 2024 On February 8, 2024, 2024 “2024 2024 2024 2024 5635 4 2024 2024 5635 4 not An aggregate 440,814 and 142,511 shares of the Company’s common stock were available for issuance of new awards granted under the Company’s equity incentive plans as of June 30, 2024 December 31, 2023 Stock Options Options granted to employees typically become exercisable over a four ten four ten ten During the three June 30, 2024 2023 six June 30, 2024 2023 June 30, 2024 The following table presents a summary of stock option activity for the three June 30, 2024 2023 Three Months Ended June 30, 2024 2023 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 3,239,384 7.38 1,216,953 18.03 Grants 64,000 3.00 17,321 2.55 Forfeitures and expirations (27,491 ) 12.80 (17,229 ) 45.18 Exercises — — — — Options outstanding at period end 3,275,893 7.25 1,217,045 17.43 Options exercisable at period end 1,245,003 13.51 893,401 22.07 Weighted average per share fair value of options granted during the period $ 2.19 $ 1.77 The following table presents a summary of stock option activity for the six June 30, 2024 2023 Six Months Ended June 30, 2024 2023 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 3,194,574 7.42 1,175,339 19.03 Grants 163,500 3.72 117,723 2.70 Forfeitures and expirations (69,056 ) 7.55 (76,017 ) 19.41 Exercises (13,125 ) 2.82 — — Options outstanding at period end 3,275,893 7.25 1,217,045 17.43 Options exercisable at period end 1,245,003 13.51 893,401 22.07 Weighted average per share fair value of options granted during the period $ 2.60 $ 1.86 The following table provides additional information related to outstanding stock options as of June 30, 2024 Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term (in years) Value ($) (In thousands) Outstanding 3,275,893 7.25 7.25 5,600 Exercisable 1,245,003 13.51 5.88 1,206 Outstanding, vested and expected to vest 2,826,910 7.86 7.76 4,617 The following table provides additional information related to outstanding stock options as of December 31, 2023 Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term (in years) Value ($) (In thousands) Outstanding 3,194,574 7.42 8.35 2,460 Exercisable 993,037 16.34 5.40 258 Outstanding, vested and expected to vest 2,887,226 7.84 8.20 2,164 Shares outstanding, vested and expected to vest in the table above do not may As of June 30, 2024 2023 June 30, 2024 2024 Restricted Stock and Restricted Stock Units The following table presents a summary of restricted stock and RSUs activity for the three June 30, 2024 2023 Three Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 1,281,120 2.66 685,176 1.67 Grants — — — — Vested restricted stock and RSUs — — — — Forfeitures (750 ) 1.35 (3,000 ) 1.35 Restricted stock and RSUs outstanding at period end 1,280,370 2.67 682,176 1.67 The following table presents a summary of restricted stock and RSUs activity for the six June 30, 2024 2023 Six Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 1,217,076 2.35 73,594 4.98 Grants 223,300 3.77 632,050 1.39 Vested restricted stock and RSUs (159,256 ) 1.82 (20,468 ) 4.98 Forfeitures (750 ) 1.35 (3,000 ) 1.35 Restricted stock and RSUs outstanding at period end 1,280,370 2.67 682,176 1.67 Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation 718” three June 30, 2024 2023 718, Compensation - Stock Compensation 718” six June 30, 2024 2023 As of June 30, 2024 Performance-based restricted stock units During the fourth 2023, three may zero 100% zero not not The following table summarizes the PSUs activity for three June 30, 2024 2023 Three Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) PSUs outstanding at beginning of period 900,000 3.23 — — Grants — — — — Vested — — — — Forfeitures — — — — Restricted stock and RSUs outstanding at period end 900,000 3.23 — — The following table summarizes the PSUs activity for six June 30, 2024 2023 Six Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) PSUs outstanding at beginning of period 625,000 2.99 — — Grants 275,000 3.77 — — Vested — — — — Forfeitures — — — — Restricted stock and RSUs outstanding at period end 900,000 3.23 — — The Company recognized $0.9 million in compensation costs related to the PSUs during the three six June 30, 2024, June 30, 2024. three six June 30, 2023. June 30, 2024 In July 2024, Employee Stock Purchase Plan During the three June 30, 2024 2023 six June 30, 2024 2023 |
Note 13 - Income Taxes
Note 13 - Income Taxes | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Income Tax Disclosure [Text Block] | 13. In accordance with ASC 740, Income Taxes, may At the end of each interim period, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. This estimate reflects, among other items, the Company’s best estimate of operating results and foreign currency exchange rates. The Company also applies the provisions for income taxes related to, among other things, accounting for uncertain tax positions and disclosure requirements. There has been no For the three six June 30, 2024 As of December 31, 2023 382 383. not 2029 2037, 2018 2023 2043. Sections 382 383 may 382 382” may 382 382 2015 2023. 2023 382 may not 382 382 Effective January 1, 2022, five fifteen first As of December 31, 2023 2022 not not December 31, 2023 not The Company anticipates that its foreign subsidiaries will be profitable and have earnings in the future. Once the foreign subsidiaries have earnings, the Company intends to indefinitely reinvest in its foreign subsidiaries all undistributed earnings and original investments in such subsidiaries. As a result, the Company does not 740 30 25. |
Note 14 - Segment Information
Note 14 - Segment Information | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Segment Reporting Disclosure [Text Block] | 14. The Company’s operations are managed as three The Company’s U.S. and International segments represent the sales and marketing, general and administrative and research and development activities dedicated to the respective geographies. The Operating Cost segment primarily represents the general and administrative and research and development activities not Each of the Company’s U.S., International and Operating Cost segments is separately managed and is evaluated primarily upon segment income or loss from operations. Other is presented to reconcile to the Company’s consolidated totals. The Company does not not During the three June 30, 2024 2023 two six June 30, 2024 2023 two two June 30, 2024 December 31, 2023 three June 30, 2024 2023 six June 30, 2024 2023 The following table presents a summary of the Company’s reporting segments for the three June 30, 2024 2023 Three Months Ended June 30, 2024 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 17,558 $ 9,442 $ — $ — $ 27,000 Cost of goods sold, excluding depreciation and amortization (1,925 ) (1,906 ) (3,831 ) Gross profit 15,633 7,536 — — 23,169 Operating expenses: Research, development and medical affairs expenses 1,347 737 2,137 42 4,263 General and administrative expenses 341 625 5,263 1,150 7,379 Sales and marketing expenses 5,942 1,828 474 267 8,511 Depreciation and amortization — — — 3,093 3,093 Total operating expenses 7,630 3,190 7,874 4,552 23,246 Segment income (loss) from operations 8,003 4,346 (7,874 ) (4,552 ) (77 ) Other income and expenses, net — — — (3,277 ) (3,277 ) Net loss before taxes $ (3,354 ) Three Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 11,876 $ 5,662 $ — $ — $ 17,538 Cost of goods sold, excluding depreciation and amortization (1,290 ) (1,135 ) — — (2,425 ) Gross profit 10,586 4,527 — — 15,113 Operating expenses: Research, development and medical affairs expenses 1,748 842 1,033 25 3,648 General and administrative expenses 1,101 510 2,619 143 4,373 Sales and marketing expenses 4,781 1,379 225 49 6,434 Depreciation and amortization — — — 1,866 1,866 Total operating expenses 7,630 2,731 3,877 2,083 16,321 Segment income (loss) from operations 2,956 1,796 (3,877 ) (2,083 ) (1,208 ) Other income and expenses, net — — — (8,796 ) (8,796 ) Net loss before taxes $ (10,004 ) The following table presents a summary of the Company’s reporting segments for the six June 30, 2024 2023 Six Months Ended June 30, 2024 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 32,110 $ 17,901 $ — $ — $ 50,011 Cost of goods sold, excluding depreciation and amortization (3,349 ) (3,835 ) — — (7,184 ) Gross profit 28,761 14,066 — — 42,827 Operating expenses: Research, development and medical affairs expenses 2,647 1,421 4,462 94 8,624 General and administrative expenses 909 1,186 8,920 1,796 12,811 Sales and marketing expenses 12,895 3,377 908 413 17,593 Depreciation and amortization — — — 6,178 6,178 Total operating expenses 16,451 5,984 14,290 8,481 45,206 Segment income (loss) from operations 12,310 8,082 (14,290 ) (8,481 ) (2,379 ) Other income and expenses, net — — — (7,258 ) (7,258 ) Net loss before taxes $ (9,637 ) Six Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 19,456 $ 11,628 $ — $ — $ 31,084 Cost of goods sold, excluding depreciation and amortization (2,195 ) (2,258 ) — — (4,453 ) Gross profit 17,261 9,370 — — 26,631 Operating expenses: Research, development and medical affairs expenses 2,910 1,589 3,266 47 7,812 General and administrative expenses 2,205 1,227 4,814 298 8,544 Sales and marketing expenses 9,056 2,794 291 97 12,238 Depreciation and amortization — — — 2,547 2,547 Total operating expenses 14,171 5,610 8,371 2,989 31,141 Segment income (loss) from operations 3,090 3,760 (8,371 ) (2,989 ) (4,510 ) Other income and expenses, net — — — (10,462 ) (10,462 ) Net loss before taxes $ (14,972 ) |
Note 15 - Fair Value
Note 15 - Fair Value | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Fair Value Disclosures [Text Block] | 15. The Company applies FASB ASC 820, Fair Value Measurements 820” 820 1 3 three ● Level 1 ● Level 2 not ● Level 3 Pursuant to the Company’s warrant agreement with Ocumension, the Company has the right to exercise the warrants at its option, which are considered to be derivative instruments and classified as non-current warrant assets. The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in the fair value during each reporting period are reported in the consolidated statement of operations. There have been no three June 30, 2024 2023. The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company’s notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The following fair value table presents information about certain of the Company’s assets measured at fair value on a recurring basis: June 30, 2024 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 7 $ — $ 7 Assets measured at fair value $ — $ 7 $ — $ 7 December 31, 2023 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 52 $ — $ 52 Assets measured at fair value $ — $ 52 $ — $ 52 ( 1 The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in this value each reporting period are reported in the condensed consolidated statement of operations. |
Note 16 - Subsequent Event
Note 16 - Subsequent Event | 6 Months Ended |
Jun. 30, 2024 | |
Notes to Financial Statements | |
Subsequent Events [Text Block] | 16. On July 17, 2024, February 5, 2016, not five two The New Siegfried Agreement contains customary representations and warranties. The assertions embodied in the representations and warrants were made solely for purposes of the transaction contemplated therein and may may may may may no In July 2024, In August 2024, no |
Insider Trading Arrangements
Insider Trading Arrangements | 6 Months Ended |
Jun. 30, 2024 | |
Insider Trading Arr Line Items | |
Material Terms of Trading Arrangement [Text Block] | 5. Other Information Not |
Rule 10b5-1 Arrangement Terminated [Flag] | false |
Rule 10b5-1 Arrangement Adopted [Flag] | false |
Non-Rule 10b5-1 Arrangement Terminated [Flag] | false |
Non-Rule 10b5-1 Arrangement Adopted [Flag] | false |
Significant Accounting Policies
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Business Combinations Policy [Policy Text Block] | Acquisition of Intangible Assets The Company accounts for the acquisition of pharmaceutical product licenses as an asset acquisition in accordance with Business Combinations (Topic 805 Accounting for Contract Assets and Contract Liabilities from Contracts with Customers 805” 805 not |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Foreign Currency Translation The financial statements of each of the Company’s subsidiaries with a functional currency other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. Foreign currency transaction gains and losses are included in other (expense) income, net in the results of operations. |
New Accounting Pronouncements, Policy [Policy Text Block] | Adoption of New Accounting Standards In June 2022, No. 2022 03, Fair Value Measurement (Topic 820 Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions not not January 1, 2024. not In November 2023, No. 2023 07, Segment Reporting (Topic 280 Improvements to Reportable Segment Disclosures December 15, 2023, December 15, 2024. January 1, 2024. not Accounting Standards Issued but Not In March 2020, 2020 04, Reference Rate Reform (Topic 848 2020 04” December 31, 2022. December 2022, No. 2022 06, Reference Rate Reform (Topic 848 848, 2020 04. 2020 04 may 2020 04 December 31, 2022, December 31, 2024. not In October 2023, No. 2023 06, Disclosure Improvements: Codification Amendments in Response to the SEC s Disclosure Update and Simplification Initiative 2023 06” 2023 06 X 2023 06 In December 2023, 2023 09, Income Taxes (Topic 740 2023 09” 2023 09 2023 09 January 1, 2025. 2023 09 |
Note 4 - Revenue Recognition (T
Note 4 - Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Accounts Receivable, Allowance for Credit Loss [Table Text Block] | Three Months Ended June 30, 2024 2023 (In thousands) Beginning balance $ 186 $ 185 Provision for credit losses — 625 Write-off of bad debt — (625 ) Ending Balance $ 186 $ 185 For the Six Months Ended June 30, 2024 2023 (In thousands) Beginning balance $ 1,222 $ — Provision for credit losses 176 1,496 Write-off of bad debt (1,212 ) (1,311 ) Ending Balance $ 186 $ 185 |
Note 5 - Leases (Tables)
Note 5 - Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Operating Lease by Balance Sheet Information [Table Text Block] | June 30, December 31, 2024 2023 (In thousands) Non-current assets: Right-of-use assets, net $ 996 $ 1,124 Total lease assets $ 996 $ 1,124 Current liabilities: Accrued expenses $ 535 $ 634 Non-current liabilities: Other non-current liabilities 1,691 1,826 Total lease liabilities $ 2,226 $ 2,460 |
Lessee, Operating Lease, Liability, to be Paid, Maturity [Table Text Block] | Years Ending December 31 (In thousands) 2024 (remaining) $ 319 2025 474 2026 488 2027 503 2028 518 Thereafter 534 Total 2,836 Less amount representing interest (610 ) Present value of minimum lease payments 2,226 Less current portion (as a portion of accrued expenses) (535 ) Non-current portion (as a portion of other non-current liabilities) $ 1,691 |
Schedule of Finance Lease Balance Sheet Information [Table Text Block] | June 30, December 31, 2024 2023 (In thousands) Non-current assets: Property and equipment, net $ 589 $ 554 Total lease assets $ 589 $ 554 Current liabilities: Finance lease obligations $ 245 $ 194 Non-current liabilities: Finance lease obligations - less current portion 244 256 Total lease liabilities $ 489 $ 450 |
Finance Lease, Liability, to be Paid, Maturity [Table Text Block] | Years Ending December 31 (In thousands) 2024 (remaining) $ 195 2025 284 2026 182 2027 13 Total 674 Less amount representing interest (185 ) Present value of minimum lease payments 489 Less current portion (245 ) Non-current portion $ 244 |
Note 6 - Inventory (Tables)
Note 6 - Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Inventory, Current [Table Text Block] | June 30, December 31, 2024 2023 (In thousands) Component parts (1) $ 653 $ 688 Work-in-process (2) 308 134 Finished goods 2,494 1,057 Total Inventory $ 3,455 $ 1,879 |
Note 7 - Intangible Assets (Tab
Note 7 - Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | Years Ending December 31 (In thousands) 2024 (remaining) $ 978 2025 1,940 2026 1,940 2027 1,191 Total $ 6,049 Years Ending December 31 (In thousands) 2024 (remaining) $ 4,853 2025 9,627 2026 9,627 2027 9,627 2028 9,654 Thereafter 42,150 Total $ 85,538 |
Note 10 - Earnings (Loss) Per_2
Note 10 - Earnings (Loss) Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | June 30, 2024 2023 Series B convertible preferred stock — 45,272,874 Common stock warrants 1,600,000 1,600,000 Stock options 3,275,893 1,217,045 Restricted stock units (“RSUs”) 869,638 — Performance stock units (“PSUs”) 900,000 — Total 6,645,531 48,089,919 |
Note 12 - Stock-based Compens_2
Note 12 - Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Share-Based Payment Arrangement, Option, Activity [Table Text Block] | Three Months Ended June 30, 2024 2023 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 3,239,384 7.38 1,216,953 18.03 Grants 64,000 3.00 17,321 2.55 Forfeitures and expirations (27,491 ) 12.80 (17,229 ) 45.18 Exercises — — — — Options outstanding at period end 3,275,893 7.25 1,217,045 17.43 Options exercisable at period end 1,245,003 13.51 893,401 22.07 Weighted average per share fair value of options granted during the period $ 2.19 $ 1.77 Six Months Ended June 30, 2024 2023 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 3,194,574 7.42 1,175,339 19.03 Grants 163,500 3.72 117,723 2.70 Forfeitures and expirations (69,056 ) 7.55 (76,017 ) 19.41 Exercises (13,125 ) 2.82 — — Options outstanding at period end 3,275,893 7.25 1,217,045 17.43 Options exercisable at period end 1,245,003 13.51 893,401 22.07 Weighted average per share fair value of options granted during the period $ 2.60 $ 1.86 Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term (in years) Value ($) (In thousands) Outstanding 3,275,893 7.25 7.25 5,600 Exercisable 1,245,003 13.51 5.88 1,206 Outstanding, vested and expected to vest 2,826,910 7.86 7.76 4,617 Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term (in years) Value ($) (In thousands) Outstanding 3,194,574 7.42 8.35 2,460 Exercisable 993,037 16.34 5.40 258 Outstanding, vested and expected to vest 2,887,226 7.84 8.20 2,164 |
Share-Based Payment Arrangement, Restricted Stock Unit, Activity [Table Text Block] | Three Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 1,281,120 2.66 685,176 1.67 Grants — — — — Vested restricted stock and RSUs — — — — Forfeitures (750 ) 1.35 (3,000 ) 1.35 Restricted stock and RSUs outstanding at period end 1,280,370 2.67 682,176 1.67 Six Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 1,217,076 2.35 73,594 4.98 Grants 223,300 3.77 632,050 1.39 Vested restricted stock and RSUs (159,256 ) 1.82 (20,468 ) 4.98 Forfeitures (750 ) 1.35 (3,000 ) 1.35 Restricted stock and RSUs outstanding at period end 1,280,370 2.67 682,176 1.67 |
Schedule of Nonvested Performance-Based Units Activity [Table Text Block] | Three Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) PSUs outstanding at beginning of period 900,000 3.23 — — Grants — — — — Vested — — — — Forfeitures — — — — Restricted stock and RSUs outstanding at period end 900,000 3.23 — — Six Months Ended June 30, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) PSUs outstanding at beginning of period 625,000 2.99 — — Grants 275,000 3.77 — — Vested — — — — Forfeitures — — — — Restricted stock and RSUs outstanding at period end 900,000 3.23 — — |
Note 14 - Segment Information (
Note 14 - Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Schedule of Segment Reporting Information, by Segment [Table Text Block] | Three Months Ended June 30, 2024 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 17,558 $ 9,442 $ — $ — $ 27,000 Cost of goods sold, excluding depreciation and amortization (1,925 ) (1,906 ) (3,831 ) Gross profit 15,633 7,536 — — 23,169 Operating expenses: Research, development and medical affairs expenses 1,347 737 2,137 42 4,263 General and administrative expenses 341 625 5,263 1,150 7,379 Sales and marketing expenses 5,942 1,828 474 267 8,511 Depreciation and amortization — — — 3,093 3,093 Total operating expenses 7,630 3,190 7,874 4,552 23,246 Segment income (loss) from operations 8,003 4,346 (7,874 ) (4,552 ) (77 ) Other income and expenses, net — — — (3,277 ) (3,277 ) Net loss before taxes $ (3,354 ) Three Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 11,876 $ 5,662 $ — $ — $ 17,538 Cost of goods sold, excluding depreciation and amortization (1,290 ) (1,135 ) — — (2,425 ) Gross profit 10,586 4,527 — — 15,113 Operating expenses: Research, development and medical affairs expenses 1,748 842 1,033 25 3,648 General and administrative expenses 1,101 510 2,619 143 4,373 Sales and marketing expenses 4,781 1,379 225 49 6,434 Depreciation and amortization — — — 1,866 1,866 Total operating expenses 7,630 2,731 3,877 2,083 16,321 Segment income (loss) from operations 2,956 1,796 (3,877 ) (2,083 ) (1,208 ) Other income and expenses, net — — — (8,796 ) (8,796 ) Net loss before taxes $ (10,004 ) Six Months Ended June 30, 2024 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 32,110 $ 17,901 $ — $ — $ 50,011 Cost of goods sold, excluding depreciation and amortization (3,349 ) (3,835 ) — — (7,184 ) Gross profit 28,761 14,066 — — 42,827 Operating expenses: Research, development and medical affairs expenses 2,647 1,421 4,462 94 8,624 General and administrative expenses 909 1,186 8,920 1,796 12,811 Sales and marketing expenses 12,895 3,377 908 413 17,593 Depreciation and amortization — — — 6,178 6,178 Total operating expenses 16,451 5,984 14,290 8,481 45,206 Segment income (loss) from operations 12,310 8,082 (14,290 ) (8,481 ) (2,379 ) Other income and expenses, net — — — (7,258 ) (7,258 ) Net loss before taxes $ (9,637 ) Six Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 19,456 $ 11,628 $ — $ — $ 31,084 Cost of goods sold, excluding depreciation and amortization (2,195 ) (2,258 ) — — (4,453 ) Gross profit 17,261 9,370 — — 26,631 Operating expenses: Research, development and medical affairs expenses 2,910 1,589 3,266 47 7,812 General and administrative expenses 2,205 1,227 4,814 298 8,544 Sales and marketing expenses 9,056 2,794 291 97 12,238 Depreciation and amortization — — — 2,547 2,547 Total operating expenses 14,171 5,610 8,371 2,989 31,141 Segment income (loss) from operations 3,090 3,760 (8,371 ) (2,989 ) (4,510 ) Other income and expenses, net — — — (10,462 ) (10,462 ) Net loss before taxes $ (14,972 ) |
Note 15 - Fair Value (Tables)
Note 15 - Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Notes Tables | |
Fair Value, Assets Measured on Recurring Basis [Table Text Block] | June 30, 2024 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 7 $ — $ 7 Assets measured at fair value $ — $ 7 $ — $ 7 December 31, 2023 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 52 $ — $ 52 Assets measured at fair value $ — $ 52 $ — $ 52 |
Note 1 - Nature of Operations (
Note 1 - Nature of Operations (Details Textual) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 21, 2024 USD ($) $ / shares | Jun. 30, 2024 USD ($) $ / shares | Jun. 30, 2024 USD ($) $ / shares | Dec. 31, 2027 USD ($) | Dec. 31, 2026 USD ($) | May 09, 2024 | Dec. 31, 2023 $ / shares | |
Number of Countries in Which Product Has Received Marketing Authorization and Reimbursement for the Treatment of Diabetic Macular Edema | 24 | 24 | |||||
Number of Countries in Which Product is Indicated for the Treatment of Vision Impairment Associated With Chronic D M E Considered Insufficiently Responsive to Available Therapies | 17 | 17 | |||||
Number of Countries Authorized for Marketing | 17 | 17 | |||||
Number of Countries With Reimbursement Approval | 10 | 10 | |||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Contingent Value Rights Agreement [Member] | ANI Pharmaceuticals, Inc. [Member] | |||||||
Contingent Value Right, Payment, Nearest Rounded Factor | 0.01 | ||||||
Contingent Value Right, Payment, Price Per Share (in dollars per share) | $ / shares | $ 0.01 | ||||||
Contingent Value Right, Period of Payment for Milestone Attained (Day) | 15 days | ||||||
Contingent Value Rights, Minimum Percentage Ownership for Audit and Enforcement Rights | 35% | ||||||
Contingent Value Rights Agreement [Member] | ANI Pharmaceuticals, Inc. [Member] | Forecast [Member] | |||||||
Contingent Milestone, Net Revenue | $ 160,000,000 | $ 140,000,000 | |||||
Contingent Value Right, Payment, Price Multiplier, Exceeding Revenue Milestone | 0.25 | 0.25 | |||||
Contingent Value Right, Payment, Price Multiplier Denominator, Exceeding Revenue Milestone | $ 15,000,000 | $ 10,000,000 | |||||
Alimera Sciences, INC. [Member] | Caligan [Member] | |||||||
Subsidiary, Ownership Percentage, Noncontrolling Owner | 32.10% | ||||||
Agreement and Plan of Merger with ANI Pharmaceuticals, Inc. and ANIP Merger Sub INC. [Member] | |||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.01 | ||||||
Business Acquisition, Share Price (in dollars per share) | $ / shares | $ 5.5 | ||||||
Business Acquisition, Contingent Value Right Per Share | 1 | ||||||
Business Acquisition, Period to File Proxy (Day) | 25 days | ||||||
Business Acquisition, Termination Fee | $ 10,400,000 | ||||||
Business Combination, Acquisition Related Costs | $ 2,200,000 | $ 2,200,000 | |||||
Agreement and Plan of Merger with ANI Pharmaceuticals, Inc. and ANIP Merger Sub INC. [Member] | Performance Shares [Member] | |||||||
Business Acquisition, Assumed Percentage of Performance Metrics Achieved | 100% |
Note 2 - Basis of Presentation
Note 2 - Basis of Presentation (Details Textual) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents | $ 10.9 | $ 12.1 |
Note 4 - Revenue Recognition (D
Note 4 - Revenue Recognition (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Accounts Receivable, Allowance for Credit Loss, Current | $ 200 | $ 200 | $ 200 | $ 200 |
Accounts Receivable, Credit Loss Expense (Reversal) | $ 0 | $ 625 | $ 176 | $ 1,496 |
Note 4 - Revenue Recognition -
Note 4 - Revenue Recognition - Schedule of Allowance for Credit Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Beginning balance | $ 186 | $ 185 | $ 1,222 | $ 0 |
Provision for credit losses | 0 | 625 | 176 | 1,496 |
Write-off of bad debt | 0 | (625) | (1,212) | (1,311) |
Ending Balance | $ 186 | $ 185 | $ 186 | $ 185 |
Note 5 - Leases (Details Textua
Note 5 - Leases (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Operating Lease, Cost | $ 100 | $ 300 | $ 300 | $ 400 |
Operating Lease, Payments | 200 | 300 | 200 | 400 |
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | $ 0 | 0 | $ 0 | 0 |
Operating Lease, Weighted Average Remaining Lease Term (Year) | 5 years 3 months 18 days | 5 years 3 months 18 days | ||
Operating Lease, Weighted Average Discount Rate, Percent | 9.40% | 9.40% | ||
Finance Lease, Interest Expense | $ 100 | 100 | $ 100 | 100 |
Finance Lease, Principal Payments | 100 | 100 | 188 | 251 |
Right-of-Use Asset Obtained in Exchange for Finance Lease Liability | $ 100 | 100 | $ 200 | 100 |
Finance Lease, Weighted Average Remaining Lease Term (Year) | 1 year 3 months 18 days | 1 year 3 months 18 days | ||
Finance Lease, Weighted Average Discount Rate, Percent | 10.20% | 10.20% | ||
Finance Lease Equipment [Member] | ||||
Depreciation | $ 100 | $ 100 | $ 100 | $ 100 |
Minimum [Member] | ||||
Lessee, Operating Lease, Renewal Term (Year) | 1 year | 1 year | ||
Maximum [Member] | ||||
Lessee, Operating Lease, Renewal Term (Year) | 8 years | 8 years |
Note 5 - Leases - Schedule of O
Note 5 - Leases - Schedule of Operating Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Right-of-use assets, net | $ 996 | $ 1,124 |
Accrued expenses | 535 | 634 |
Non-current portion (as a portion of other non-current liabilities) | 1,691 | 1,826 |
Total lease liabilities | $ 2,226 | $ 2,460 |
Note 5 - Leases - Schedule of_2
Note 5 - Leases - Schedule of Operating Lease Maturities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
2024 (remaining) | $ 319 | |
2025 | 474 | |
2026 | 488 | |
2027 | 503 | |
2028 | 518 | |
Thereafter | 534 | |
Total | 2,836 | |
Less amount representing interest | (610) | |
Present value of minimum lease payments | 2,226 | $ 2,460 |
Less current portion (as a portion of accrued expenses) | (535) | (634) |
Non-current portion (as a portion of other non-current liabilities) | $ 1,691 | $ 1,826 |
Note 5 - Leases - Schedule of F
Note 5 - Leases - Schedule of Finance Leases (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Finance lease assets | $ 589 | $ 554 |
Finance lease obligations | 245 | 194 |
Finance lease obligations - less current portion | 244 | 256 |
Total lease liabilities | $ 489 | $ 450 |
Note 5 - Leases - Schedule of_3
Note 5 - Leases - Schedule of Finance Lease Maturities (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
2024 (remaining) | $ 195 | |
2025 | 284 | |
2026 | 182 | |
2027 | 13 | |
Total | 674 | |
Less amount representing interest | (185) | |
Present value of minimum lease payments | 489 | $ 450 |
Less current portion | (245) | (194) |
Non-current portion | $ 244 | $ 256 |
Note 6 - Inventory - Schedule o
Note 6 - Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | |
Component parts | [1] | $ 653 | $ 688 |
Work-in-process | [2] | 308 | 134 |
Finished goods | 2,494 | 1,057 | |
Total Inventory | $ 3,455 | $ 1,879 | |
[1]Component parts inventory consists of manufactured components of the ILUVIEN applicator.[2]Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or European Economic Area regulatory authorities. |
Note 7 - Intangible Assets (Det
Note 7 - Intangible Assets (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2024 | Dec. 31, 2023 | May 17, 2023 | Sep. 30, 2014 | |
Finite-Lived Intangible Assets, Net | $ 91,587 | $ 91,587 | $ 97,355 | |||||
ILUVIEN [Member] | ||||||||
Finite-Lived Intangible Assets, Gross | $ 25,000 | |||||||
Finite-Lived Intangible Asset, Useful Life (Year) | 13 years | |||||||
Amortization of Intangible Assets | 500 | $ 500 | 1,000 | $ 6,000 | ||||
Finite-Lived Intangible Assets, Net | 6,049 | 6,049 | 7,000 | |||||
YUTIQ [Member] | ||||||||
Finite-Lived Intangible Assets, Gross | $ 96,400 | $ 96,400 | ||||||
Finite-Lived Intangible Asset, Useful Life (Year) | 10 years | 10 years | ||||||
Amortization of Intangible Assets | $ 2,400 | $ 1,200 | $ 4,800 | $ 1,200 | ||||
Finite-Lived Intangible Assets, Net | $ 85,538 | $ 85,538 | $ 90,300 | |||||
License Agreement, Upfront Payment | $ 75,000 | |||||||
YUTIQ [Member] | Forecast [Member] | ||||||||
Collaborative Agreement, Additional Guaranteed Payments | $ 3,800 |
Note 7 - Intangible Assets - Sc
Note 7 - Intangible Assets - Schedule of Future Amortization Expense (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Total | $ 91,587 | $ 97,355 |
ILUVIEN [Member] | ||
2024 (remaining) | 978 | |
2025 | 1,940 | |
2026 | 1,940 | |
2027 | 1,191 | |
Total | 6,049 | 7,000 |
YUTIQ [Member] | ||
2024 (remaining) | 4,853 | |
2025 | 9,627 | |
2026 | 9,627 | |
2027 | 9,627 | |
Total | 85,538 | $ 90,300 |
2028 | 9,654 | |
Thereafter | $ 42,150 |
Note 8 - License Agreements (De
Note 8 - License Agreements (Details Textual) | 3 Months Ended | 6 Months Ended | ||||||||||||||
Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2025 USD ($) | Dec. 31, 2024 USD ($) | Jun. 19, 2024 USD ($) | Dec. 31, 2023 USD ($) | Apr. 14, 2021 USD ($) $ / shares shares | Apr. 14, 2021 $ / shares | Apr. 09, 2021 | Dec. 17, 2020 USD ($) | Mar. 31, 2019 USD ($) | Dec. 12, 2018 | Jul. 10, 2017 | Jul. 01, 2017 USD ($) | |
Ocumension Warrants [Member] | ||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right (in shares) | shares | 1,000,000 | |||||||||||||||
Warrants and Rights Outstanding, Term (Year) | 4 years | |||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in HKD per share) | (per share) | $ 3.07 | $ 23.88 | ||||||||||||||
Foreign Currency Exchange Rate, Translation | 0.12853 | |||||||||||||||
Eye Point Agreements [Member] | ||||||||||||||||
Collaborative Agreement, Royalty Percentage of Revenue | 20% | 2% | ||||||||||||||
Collaborative Agreement, Royalty, Percentage of Net Revenue, Under Threshold | 6% | |||||||||||||||
Collaborative Agreement, Royalty Threshold of Revenue | $ 75,000,000 | |||||||||||||||
Payments for Royalties | $ 1,900,000 | |||||||||||||||
Eye Point Agreements [Member] | Forecast [Member] | ||||||||||||||||
Collaborative Agreement, Royalty Threshold of Revenue | $ 70,000,000 | |||||||||||||||
Collaborative Agreement, Additional Guaranteed Payments | $ 7,500,000 | |||||||||||||||
SWK Agreements [Member] | ||||||||||||||||
Collaborative Agreement, Maximum Recoverable Amounts to Offset Future Royalty Payments | $ 15,000,000 | |||||||||||||||
Collaborative Arrangement, Forgiveness of Future Offset, Additional Amount | $ 5,000,000 | |||||||||||||||
Royalty Future Offset | 6,400,000 | $ 6,400,000 | $ 6,500,000 | |||||||||||||
Collaborative Agreement, Alternative Royalty, Percentage of Net Revenue | 3.125% | |||||||||||||||
Collaborative Agreement, Change of Control, Minimum Buyout Price | $ 17,250,000 | |||||||||||||||
Collaborative Agreement, Change of Control, Buyout Price, Alternative Royalty Paid or Payable Factor | 4.75 | |||||||||||||||
Collaborative Agreement, Change of Control, Buyout Price, Alternative Royalty Payable, Number of Quarters | 4 | |||||||||||||||
Ocumension License Agreement [Member] | ||||||||||||||||
Collaborative Agreement, Additional Guaranteed Payments | $ 89,000,000 | |||||||||||||||
Royalty Expense | 800,000 | $ 500,000 | 1,700,000 | $ 900,000 | ||||||||||||
License Agreement, Upfront Payment | $ 10,000,000 | |||||||||||||||
Contract with Customer, Liability | 300,000 | 300,000 | $ 400,000 | |||||||||||||
Ocumension License Agreement [Member] | Accounts Payable [Member] | ||||||||||||||||
Accrued Royalties | $ 800,000 | $ 900,000 | $ 800,000 | $ 900,000 |
Note 9 - Loan Agreements (Detai
Note 9 - Loan Agreements (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||
Mar. 06, 2024 | May 17, 2023 | Mar. 24, 2023 | Dec. 31, 2019 | Jan. 05, 2018 | Jun. 30, 2024 | Mar. 31, 2024 | Dec. 31, 2023 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration] | Secured Overnight Financing Rate (SOFR) [Member] | London Interbank Offered Rate [Member] | |||||||||
Gain (Loss) on Extinguishment of Debt | $ 0 | $ (1,079) | $ 0 | $ (1,079) | |||||||
Loan Agreement With SLR Investment Corp [Member] | |||||||||||
Debt Instrument, Face Amount | $ 72,500 | $ 67,500 | $ 47,500 | $ 45,000 | $ 40,000 | $ 72,500 | $ 72,500 | ||||
Debt Instrument, Increase (Decrease), Net | 5,000 | 2,500 | |||||||||
Line of Credit Facility, Maximum Borrowing Capacity | 20,000 | $ 15,000 | |||||||||
Long-Term Line of Credit | $ 20,000 | $ 20,000 | |||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.15% | 1.78% | |||||||||
Debt Instrument, Basis Spread on Variable Rate | 4.60% | 7.65% | |||||||||
Debt Instrument, Interest Rate, Effective Percentage | 10.48% | 10.50% | 10.48% | ||||||||
Debt Instrument, Fee Amount | $ 1,100 | $ 700 | $ 2,000 | $ 300 | $ 300 | ||||||
Debt Instrument, Term (Year) | 10 years | 10 years | 10 years | ||||||||
Debt Instrument, License Revenue Threshold | $ 82,500 | ||||||||||
Debt Instrument, Exit Fee, Percentage | 1.50% | ||||||||||
Interest Expense, Debt | 300 | $ 1,100 | $ 1,300 | ||||||||
Debt Instrument, Untriggered Exit Fee, Amount | $ 1,000 | $ 1,000 | |||||||||
Debt Issuance Costs, Net | $ 100 | $ 2,600 | |||||||||
Gain (Loss) on Extinguishment of Debt | $ (1,100) | ||||||||||
Loan Agreement With SLR Investment Corp [Member] | Maximum [Member] | |||||||||||
Debt Instrument, Fee Amount | $ 3,800 | ||||||||||
Loan Agreement With SLR Investment Corp [Member] | Exit Agreement on Achievement of Milestone [Member] | |||||||||||
Debt Instrument, Fee Amount | $ 300 | $ 1,000 | |||||||||
Debt Instrument, License Revenue Threshold | 75,000 | 80,000 | |||||||||
Debt Instrument, License Revenue Threshold 2 | $ 95,000 | $ 100,000 |
Note 10 - Earnings (Loss) Per_3
Note 10 - Earnings (Loss) Per Share - Schedule of Antidilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive securities (in shares) | 6,645,531 | 48,089,919 |
Series B Convertible Preferred Stock [Member] | ||
Antidilutive securities (in shares) | 0 | 45,272,874 |
Warrant [Member] | ||
Antidilutive securities (in shares) | 1,600,000 | 1,600,000 |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive securities (in shares) | 3,275,893 | 1,217,045 |
Restricted Stock Units (RSUs) [Member] | ||
Antidilutive securities (in shares) | 869,638 | 0 |
Performance Shares [Member] | ||
Antidilutive securities (in shares) | 900,000 | 0 |
Note 11 - Stockholders' Equit_2
Note 11 - Stockholders' Equity (Deficit) (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Aug. 07, 2024 | Aug. 15, 2023 | May 01, 2023 | Aug. 31, 2024 | Mar. 31, 2023 | Oct. 31, 2012 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2014 | |
Payments of Stock Issuance Costs | $ 0 | $ 509 | ||||||||
Preferred Stock, Shares Outstanding (in shares) | 0 | 0 | ||||||||
Common Stock, Shares Authorized (in shares) | 150,000,000 | 150,000,000 | ||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | $ 0.01 | ||||||||
Preferred Stock, Shares Authorized (in shares) | 10,000,000 | 10,000,000 | ||||||||
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | $ 0.01 | ||||||||
Common Stock, Shares, Issued (in shares) | 52,387,763 | 52,354,450 | ||||||||
Preferred Stock, Shares Issued (in shares) | 0 | 0 | ||||||||
Common Stock, Shares, Outstanding (in shares) | 52,387,763 | 52,354,450 | ||||||||
Conversion Of Series A Preferred Stock Into Common Stock [Member] | ||||||||||
Conversion of Stock, Shares Converted (in shares) | 400,000 | |||||||||
Mandatory Conversion of Series B Preferred Stock [Member] | ||||||||||
Conversion of Stock, Shares Converted (in shares) | 43,617,114 | |||||||||
Series A Preferred Stock Warrants [Member] | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 300,000 | |||||||||
Common Stock Warrants [Member] | Mandatory Conversion of Series B Preferred Stock [Member] | ||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares) | 2,000,000 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights (in HKD per share) | $ 0.01 | |||||||||
Pre-Funded Warrants [Member] | Subsequent Event [Member] | ||||||||||
Stock Issued During Period, Shares, Warrants Exercised (in shares) | 1,996,402 | 1,996,402 | ||||||||
Class of Warrant or Right, Outstanding (in shares) | 0 | |||||||||
Series A Preferred Stock [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 1,000,000 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 40,000 | |||||||||
Payments of Stock Issuance Costs | $ 600 | |||||||||
Stock Repurchased During Period, Shares (in shares) | 600,000 | |||||||||
Series B Preferred Stock [Member] | ||||||||||
Stock Issued During Period, Shares, New Issues (in shares) | 67,000 | 12,000 | ||||||||
Proceeds from Issuance or Sale of Equity | $ 67,000 | $ 12,000 | ||||||||
Shares Issued, Price Per Share (in dollars per share) | $ 1,000 | $ 1,000 | ||||||||
Preferred Stock, Shares Outstanding (in shares) | 0 |
Note 12 - Stock-based Compens_3
Note 12 - Stock-based Compensation (Details Textual) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Aug. 01, 2023 | Jul. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Feb. 08, 2024 | Dec. 31, 2023 | |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||||
Employee Stock Ownership Plan (ESOP), Compensation Expense | $ 100 | $ 100 | $ 100 | $ 100 | ||||
Share-Based Payment Arrangement, Option [Member] | ||||||||
Share-Based Payment Arrangement, Expense | 500 | 100 | 1,000 | 300 | ||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | 4,500 | $ 4,500 | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 3 years 1 month 28 days | |||||||
Share-Based Payment Arrangement, Option [Member] | Director [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 4 years | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||||||
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Employee [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year) | 4 years | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year) | 10 years | |||||||
Restricted Stock Units (RSUs) [Member] | ||||||||
Share-Based Payment Arrangement, Expense | 300 | $ 100 | $ 600 | $ 100 | ||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 3,000 | $ 3,000 | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 3 years 1 month 28 days | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 0 | 0 | 159,256 | 20,468 | ||||
Performance Shares [Member] | ||||||||
Share-Based Payment Arrangement, Expense | $ 900 | $ 0 | $ 900 | $ 0 | ||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 2,000 | $ 2,000 | ||||||
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year) | 2 years 7 months 20 days | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Requisite Service Period (Year) | 3 years | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 0 | 0 | 0 | 0 | ||||
Performance Shares [Member] | Subsequent Event [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 299,999 | |||||||
The 2023 Equity Incentive Plan [Member] | ||||||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 3,231,755 | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Percentage of Outstanding Stock Maximum | 6% | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 110,179 | 110,179 | ||||||
The 2024 Equity Incentive Plan [Member] | ||||||||
Common Stock, Capital Shares Reserved for Future Issuance (in shares) | 800,000 | |||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.01 | |||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 311,500 | 311,500 | ||||||
Equity Incentive Plans [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares) | 440,814 | 440,814 | 142,511 |
Note 12 - Stock-based Compens_4
Note 12 - Stock-based Compensation - Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Options outstanding at beginning of period (in shares) | 3,239,384 | 3,194,574 | 1,216,953 | 3,194,574 | 1,175,339 | 1,175,339 |
Options outstanding at beginning of period, weighted average exercise price (in dollars per share) | $ 7.38 | $ 7.42 | $ 18.03 | $ 7.42 | $ 19.03 | $ 19.03 |
Grants (in shares) | 64,000 | 17,321 | 163,500 | 117,723 | ||
Grants, weighted average exercise price (in dollars per share) | $ 3 | $ 2.55 | $ 3.72 | $ 2.7 | ||
Forfeitures and expirations (in shares) | (27,491) | (17,229) | (69,056) | (76,017) | ||
Forfeitures and expirations, weighted average exercise price (in dollars per share) | $ 12.8 | $ 45.18 | $ 7.55 | $ 19.41 | ||
Exercises (in shares) | 0 | 0 | (13,125) | 0 | ||
Exercises, weighted average exercise price (in dollars per share) | $ 0 | $ 0 | $ 2.82 | $ 0 | ||
Options outstanding at period end (in shares) | 3,275,893 | 3,239,384 | 1,217,045 | 3,275,893 | 1,217,045 | 3,194,574 |
Options outstanding at period end, weighted average exercise price (in dollars per share) | $ 7.25 | $ 7.38 | $ 17.43 | $ 7.25 | $ 17.43 | $ 7.42 |
Options exercisable at period end (in shares) | 1,245,003 | 893,401 | 1,245,003 | 893,401 | 993,037 | |
Options exercisable at period end, weighted average exercise price (in dollars per share) | $ 13.51 | $ 22.07 | $ 13.51 | $ 22.07 | $ 16.34 | |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 2.19 | $ 1.77 | $ 2.6 | $ 1.86 | ||
Outstanding (in shares) | 3,275,893 | 3,239,384 | 1,217,045 | 3,275,893 | 1,217,045 | 3,194,574 |
Outstanding, exercise price (in dollars per share) | $ 7.25 | $ 7.38 | $ 17.43 | $ 7.25 | $ 17.43 | $ 7.42 |
Outstanding, contractual term (Year) | 7 years 3 months | 8 years 4 months 6 days | ||||
Outstanding, intrinsic value | $ 5,600 | $ 5,600 | $ 2,460 | |||
Exercisable, contractual term (Year) | 5 years 10 months 17 days | 5 years 4 months 24 days | ||||
Exercisable, intrinsic value | $ 1,206 | $ 1,206 | $ 258 | |||
Outstanding, vested and expected to vest (in shares) | 2,826,910 | 2,826,910 | 2,887,226 | |||
Outstanding, vested and expected to vest, exercise price (in dollars per share) | $ 7.86 | $ 7.86 | $ 7.84 | |||
Outstanding, vested and expected to vest, contractual term (Year) | 7 years 9 months 3 days | 8 years 2 months 12 days | ||||
Outstanding, vested and expected to vest, intrinsic value | $ 4,617 | $ 4,617 | $ 2,164 |
Note 12 - Stock-based Compens_5
Note 12 - Stock-based Compensation - Restricted Stock Unit Activity (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock units outstanding at beginning of period (in shares) | 1,281,120 | 685,176 | 1,217,076 | 73,594 |
Stock units outstanding at beginning of period, weighted average grant date fair value (in dollars per share) | $ 2.66 | $ 1.67 | $ 2.35 | $ 4.98 |
Grants (in shares) | 0 | 0 | 223,300 | 632,050 |
Grants, weighted average grant date fair value (in dollars per share) | $ 0 | $ 0 | $ 3.77 | $ 1.39 |
Vested restricted stock and RSUs (in shares) | 0 | 0 | (159,256) | (20,468) |
Vested restricted stock and RSUs, weighted average grant date fair value (in dollars per share) | $ 0 | $ 0 | $ 1.82 | $ 4.98 |
Forfeitures (in shares) | (750) | (3,000) | (750) | (3,000) |
Forfeitures, weighted average grant date fair value (in dollars per share) | $ 1.35 | $ 1.35 | $ 1.35 | $ 1.35 |
Stock units outstanding at period end (in shares) | 1,280,370 | 682,176 | 1,280,370 | 682,176 |
Stock units outstanding at period end, weighted average grant date fair value (in dollars per share) | $ 2.67 | $ 1.67 | $ 2.67 | $ 1.67 |
Note 12 - Stock-based Compens_6
Note 12 - Stock-based Compensation - Performance Stock Unit Activity (Details) - Performance Shares [Member] - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Stock units outstanding at beginning of period (in shares) | 900,000 | 0 | 625,000 | 0 |
Stock units outstanding at beginning of period, weighted average grant date fair value (in dollars per share) | $ 3.23 | $ 0 | $ 2.99 | $ 0 |
Grants (in shares) | 0 | 0 | 275,000 | 0 |
Grants, weighted average grant date fair value (in dollars per share) | $ 0 | $ 0 | $ 3.77 | $ 0 |
Vested restricted stock and RSUs (in shares) | 0 | 0 | 0 | 0 |
Vested restricted stock and RSUs, weighted average grant date fair value (in dollars per share) | $ 0 | $ 0 | $ 0 | $ 0 |
Forfeitures (in shares) | 0 | 0 | 0 | 0 |
Forfeitures, weighted average grant date fair value (in dollars per share) | $ 0 | $ 0 | $ 0 | $ 0 |
Stock units outstanding at period end (in shares) | 900,000 | 0 | 900,000 | 0 |
Stock units outstanding at period end, weighted average grant date fair value (in dollars per share) | $ 3.23 | $ 0 | $ 3.23 | $ 0 |
Note 13 - Income Taxes (Details
Note 13 - Income Taxes (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Income Tax Expense (Benefit) | $ (43) | $ 25 | $ (75) | $ 25 | |
Domestic Tax Jurisdiction [Member] | |||||
Operating Loss Carryforwards | $ 146,800 | ||||
State and Local Jurisdiction [Member] | |||||
Operating Loss Carryforwards | 106,800 | ||||
Foreign Tax Jurisdiction [Member] | His Majesty's Revenue and Customs (HMRC) [Member] | |||||
Operating Loss Carryforwards | $ 1,100 | ||||
Minimum [Member] | |||||
Income Tax Expense (Benefit) | $ (100) | $ (100) |
Note 14 - Segment Information_2
Note 14 - Segment Information (Details Textual) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Number of Operating Segments | 3 | ||||
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | |||||
Number of Customers | 2 | 2 | 2 | 2 | |
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Two Customers [Member] | |||||
Concentration Risk, Percentage | 65% | 68% | 64% | 63% | |
Customer Concentration Risk [Member] | Revenue Benchmark [Member] | Distributor [Member] | |||||
Concentration Risk, Percentage | 64% | 41% | 58% | 44% | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||||
Number of Customers | 2 | 2 | |||
Customer Concentration Risk [Member] | Accounts Receivable [Member] | Two Customers [Member] | |||||
Concentration Risk, Percentage | 70% | 70% |
Note 14 - Segment Information -
Note 14 - Segment Information - Schedule of Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net revenue | $ 27,000 | $ 17,538 | $ 50,011 | $ 31,084 |
Cost of goods sold, excluding depreciation and amortization | (3,831) | (2,425) | (7,184) | (4,453) |
Gross profit | 23,169 | 15,113 | 42,827 | 26,631 |
Research, development and medical affairs expenses | 4,263 | 3,648 | 8,624 | 7,812 |
General and administrative expenses | 7,379 | 4,373 | 12,811 | 8,544 |
Sales and marketing expenses | 8,511 | 6,434 | 17,593 | 12,238 |
Depreciation and amortization | 3,093 | 1,866 | 6,178 | 2,547 |
Total operating expenses | 23,246 | 16,321 | 45,206 | 31,141 |
Segment income (loss) from operations | (77) | (1,208) | (2,379) | (4,510) |
Other income and expenses, net | (3,277) | (8,796) | (7,258) | (10,462) |
Net loss before taxes | (3,354) | (10,004) | (9,637) | (14,972) |
United States Segment [Member] | ||||
Net revenue | 17,558 | 11,876 | 32,110 | 19,456 |
Cost of goods sold, excluding depreciation and amortization | (1,925) | (1,290) | (3,349) | (2,195) |
Gross profit | 15,633 | 10,586 | 28,761 | 17,261 |
Research, development and medical affairs expenses | 1,347 | 1,748 | 2,647 | 2,910 |
General and administrative expenses | 341 | 1,101 | 909 | 2,205 |
Sales and marketing expenses | 5,942 | 4,781 | 12,895 | 9,056 |
Depreciation and amortization | 0 | 0 | 0 | 0 |
Total operating expenses | 7,630 | 7,630 | 16,451 | 14,171 |
Segment income (loss) from operations | 8,003 | 2,956 | 12,310 | 3,090 |
Other income and expenses, net | 0 | 0 | 0 | 0 |
International Segment [Member] | ||||
Net revenue | 9,442 | 5,662 | 17,901 | 11,628 |
Cost of goods sold, excluding depreciation and amortization | (1,906) | (1,135) | (3,835) | (2,258) |
Gross profit | 7,536 | 4,527 | 14,066 | 9,370 |
Research, development and medical affairs expenses | 737 | 842 | 1,421 | 1,589 |
General and administrative expenses | 625 | 510 | 1,186 | 1,227 |
Sales and marketing expenses | 1,828 | 1,379 | 3,377 | 2,794 |
Depreciation and amortization | 0 | 0 | 0 | 0 |
Total operating expenses | 3,190 | 2,731 | 5,984 | 5,610 |
Segment income (loss) from operations | 4,346 | 1,796 | 8,082 | 3,760 |
Other income and expenses, net | 0 | 0 | 0 | 0 |
Operating Cost Segment [Member] | ||||
Net revenue | 0 | 0 | 0 | 0 |
Cost of goods sold, excluding depreciation and amortization | 0 | 0 | 0 | |
Gross profit | 0 | 0 | 0 | 0 |
Research, development and medical affairs expenses | 2,137 | 1,033 | 4,462 | 3,266 |
General and administrative expenses | 5,263 | 2,619 | 8,920 | 4,814 |
Sales and marketing expenses | 474 | 225 | 908 | 291 |
Depreciation and amortization | 0 | 0 | 0 | 0 |
Total operating expenses | 7,874 | 3,877 | 14,290 | 8,371 |
Segment income (loss) from operations | (7,874) | (3,877) | (14,290) | (8,371) |
Other income and expenses, net | 0 | 0 | 0 | 0 |
Other Operating Segment [Member] | ||||
Net revenue | 0 | 0 | 0 | 0 |
Cost of goods sold, excluding depreciation and amortization | 0 | 0 | 0 | |
Gross profit | 0 | 0 | 0 | 0 |
Research, development and medical affairs expenses | 42 | 25 | 94 | 47 |
General and administrative expenses | 1,150 | 143 | 1,796 | 298 |
Sales and marketing expenses | 267 | 49 | 413 | 97 |
Depreciation and amortization | 3,093 | 1,866 | 6,178 | 2,547 |
Total operating expenses | 4,552 | 2,083 | 8,481 | 2,989 |
Segment income (loss) from operations | (4,552) | (2,083) | (8,481) | (2,989) |
Other income and expenses, net | $ (3,277) | $ (8,796) | $ (7,258) | $ (10,462) |
Note 15 - Fair Value - Schedule
Note 15 - Fair Value - Schedule of Fair Value Assets Measured on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 | |
Warrant asset | [1] | $ 7 | $ 52 |
Assets measured at fair value | 7 | 52 | |
Fair Value, Inputs, Level 1 [Member] | |||
Warrant asset | [1] | 0 | 0 |
Assets measured at fair value | 0 | 0 | |
Fair Value, Inputs, Level 2 [Member] | |||
Warrant asset | [1] | 7 | 52 |
Assets measured at fair value | 7 | 52 | |
Fair Value, Inputs, Level 3 [Member] | |||
Warrant asset | [1] | 0 | 0 |
Assets measured at fair value | $ 0 | $ 0 | |
[1]The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in this value each reporting period are reported in the condensed consolidated statement of operations. |
Note 16 - Subsequent Event (Det
Note 16 - Subsequent Event (Details Textual) - shares | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Aug. 07, 2024 | Jul. 17, 2024 | Aug. 31, 2024 | Jul. 31, 2024 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Performance Shares [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 0 | 0 | 0 | 0 | ||||
Subsequent Event [Member] | Pre-Funded Warrants [Member] | ||||||||
Stock Issued During Period, Shares, Warrants Exercised (in shares) | 1,996,402 | 1,996,402 | ||||||
Subsequent Event [Member] | Performance Shares [Member] | ||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Vested in Period (in shares) | 299,999 | |||||||
New Siegfried Agreement [Member] | Subsequent Event [Member] | ||||||||
Collaborative Agreement, Term (Year) | 5 years | |||||||
Collaborative Agreement, Renewal Term (Year) | 2 years |