Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 09, 2023 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Current Fiscal Year End Date | --12-31 | |
Document Period End Date | Jun. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Transition Report | false | |
Entity File Number | 001-34703 | |
Entity Registrant Name | Alimera Sciences, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-0028718 | |
Entity Address, Address Line One | 6310 Town Square | |
Entity Address, Address Line Two | 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, $0.01 par value per share | |
Trading Symbol | ALIM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Smaller Reporting Company | true | |
Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity common stock, shares outstanding (in shares) | 8,801,727 | |
Entity Central Index Key | 0001267602 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q2 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 18,775 | $ 5,274 |
Restricted cash | 32 | 30 |
Accounts receivable, net | 22,589 | 19,612 |
Prepaid expenses and other current assets | 3,571 | 2,892 |
Inventory | 1,055 | 1,605 |
Total current assets | 46,022 | 29,413 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | 2,465 | 2,525 |
Right of use assets, net | 1,277 | 1,395 |
Intangible assets, net | 104,935 | 8,957 |
Deferred tax asset | 131 | 129 |
Warrant asset | 93 | 183 |
TOTAL ASSETS | 154,923 | 42,602 |
CURRENT LIABILITIES: | ||
Accounts payable | 8,040 | 10,088 |
Accrued expenses | 6,002 | 3,998 |
Notes payable | 25,313 | |
Finance lease obligations | 203 | 333 |
Total current liabilities | 14,245 | 39,732 |
NON-CURRENT LIABILITIES: | ||
Notes payable, net of discount | 63,954 | 18,683 |
Common stock warrants | 3,471 | |
Accrued licensor payments | 21,079 | |
Other non-current liabilities | 5,944 | 4,995 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS’ EQUITY (DEFICIT): | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 8,803,727 shares issued and outstanding at June 30, 2023 and 6,995,513 shares issued and outstanding at December 31, 2022 | 88 | 70 |
Additional paid-in capital | 386,979 | 378,238 |
Accumulated deficit | (412,779) | (415,388) |
Accumulated other comprehensive loss | (2,783) | (2,955) |
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | 46,230 | (20,808) |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | 154,923 | 42,602 |
Series A Preferred Stock [Member] | ||
STOCKHOLDERS’ EQUITY (DEFICIT): | ||
Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2023 and December 31, 2022: | $ 19,227 | |
Series B Preferred Stock [Member] | ||
STOCKHOLDERS’ EQUITY (DEFICIT): | ||
Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2023 and December 31, 2022: | $ 74,725 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 8,803,727 | 6,995,513 |
Common stock, shares outstanding (in shares) | 8,803,727 | 6,995,513 |
Series A Preferred Stock [Member] | ||
Preferred stock, shares authorized (in shares) | 0 | 1,300,000 |
Preferred stock, shares issued (in shares) | 0 | 600,000 |
Preferred stock, shares outstanding (in shares) | 0 | 600,000 |
Preferred stock, liquidation preference | $ 24,000 | |
Series B Preferred Stock [Member] | ||
Preferred stock, shares authorized (in shares) | 78,617 | 0 |
Preferred stock, shares issued (in shares) | 78,617 | 0 |
Preferred stock, shares outstanding (in shares) | 78,617 | 0 |
Preferred stock, liquidation preference | $ 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Condensed Consolidated Statements of Operations [Abstract] | ||||
REVENUE, NET | $ 17,538 | $ 14,604 | $ 31,084 | $ 26,502 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (2,425) | (2,166) | (4,453) | (3,846) |
GROSS PROFIT | 15,113 | 12,438 | 26,631 | 22,656 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,648 | 3,932 | 7,812 | 7,515 |
GENERAL AND ADMINISTRATIVE EXPENSES | 4,373 | 2,945 | 8,544 | 6,185 |
SALES AND MARKETING EXPENSES | 6,434 | 6,865 | 12,238 | 13,718 |
DEPRECIATION AND AMORTIZATION | 1,866 | 670 | 2,547 | 1,359 |
OPERATING EXPENSES | 16,321 | 14,412 | 31,141 | 28,777 |
LOSS FROM OPERATIONS | (1,208) | (1,974) | (4,510) | (6,121) |
INTEREST EXPENSE AND OTHER | (1,694) | (1,383) | (3,361) | (2,747) |
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET | (7) | 38 | (20) | 146 |
LOSS ON EXTINGUISHMENT OF DEBT | (1,079) | (1,079) | ||
CHANGE IN FAIR VALUE OF WARRANT ASSET | (105) | 221 | (91) | (331) |
CHANGE IN FAIR VALUE OF WARRANT LIABILITY | (5,911) | (5,911) | ||
NET LOSS BEFORE TAXES | (10,004) | (3,098) | (14,972) | (9,053) |
INCOME TAX PROVISION | (25) | (17) | (25) | (17) |
NET LOSS | (10,029) | (3,115) | (14,997) | (9,070) |
PREFERRED STOCK DIVIDENDS | (669) | (683) | ||
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ (10,698) | $ (3,115) | $ (15,680) | $ (9,070) |
NET LOSS PER SHARE — Basic | $ (1.32) | $ (0.45) | $ (2.07) | $ (1.30) |
NET LOSS PER SHARE — Diluted | $ (1.32) | $ (0.45) | $ (2.07) | $ (1.30) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic | 8,093,640 | 6,999,707 | 7,565,868 | 6,995,247 |
WEIGHTED AVERAGE SHARES OUTSTANDING — Diluted | 8,093,640 | 6,999,707 | 7,565,868 | 6,995,247 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Condensed Consolidated Statements of Comprehensive Loss [Abstract] | ||||
NET LOSS | $ (10,029) | $ (3,115) | $ (14,997) | $ (9,070) |
OTHER COMPREHENSIVE (LOSS) INCOME | ||||
Foreign currency translation adjustments | (923) | 172 | (1,279) | |
TOTAL OTHER COMPREHENSIVE (LOSS) INCOME | (923) | 172 | (1,279) | |
COMPREHENSIVE LOSS | $ (10,029) | $ (4,038) | $ (14,825) | $ (10,349) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (14,997) | $ (9,070) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,547 | 1,359 |
Loss on extinguishment of debt | 1,079 | |
Unrealized foreign currency transaction gain, net | 20 | (146) |
Amortization of debt discount and deferred financing costs | 488 | 552 |
Stock-based compensation expense | 442 | 581 |
Change in fair value of warrant asset | 91 | 331 |
Change in fair value of warrant liability | 5,911 | |
Changes in assets and liabilities: | ||
Accounts receivable | (2,859) | (1,725) |
Prepaid expenses and other current assets | (539) | 507 |
Inventory | 559 | 942 |
Accounts payable | (2,066) | (880) |
Accrued expenses and other current liabilities | 202 | (181) |
Other long-term liabilities | 917 | (81) |
Net cash used in operating activities | (8,205) | (7,811) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (171) | (41) |
Purchase of intangible assets | (75,272) | |
Net cash used in investing activities | (75,443) | (41) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of Series B Convertible Preferred Stock | 78,339 | |
Stock issuance costs | (509) | |
Proceeds from issuance of common stock | 2,404 | 40 |
Issuance of debt | 22,500 | |
Payment of debt costs | (4,108) | |
Payment of finance lease obligations | (251) | (204) |
Repurchase of Series A Preferred Stock | (938) | |
Repurchase of common stock | (314) | |
Net cash provided by (used in) financing activities | 97,123 | (164) |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 28 | (638) |
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 13,503 | (8,654) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period | 5,304 | 16,544 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of period | 18,807 | 7,890 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 3,136 | 2,145 |
Cash paid for income taxes | 21 | 182 |
Supplemental schedule of noncash investing and financing activities: | ||
Note payable end of term payment accrued but unpaid | 3,375 | $ 2,250 |
Intangible asset acquired but unpaid | $ 22,850 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common Stock [Member] Common Class A [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 Class A [Member] | Additional Paid-In Capital [Member] Series B Preferred Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] Series A Preferred Stock [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] | Common Class A [Member] | Series A Preferred Stock [Member] | Series B Preferred Stock [Member] | Total |
Beginning balance (in shares) at Dec. 31, 2021 | 6,935,154 | 600,000 | ||||||||||||
Beginning balance at Dec. 31, 2021 | $ 69 | $ 19,227 | $ 377,229 | $ (397,281) | $ (1,849) | $ (2,605) | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 57,500 | |||||||||||||
Issuance of common stock, net of issuance costs | $ 1 | 1 | ||||||||||||
Stock-based compensation expense | 312 | 312 | ||||||||||||
Net loss | (5,955) | (5,955) | ||||||||||||
Foreign currency translation adjustments | (356) | (356) | ||||||||||||
Ending balance (in shares) at Mar. 31, 2022 | 6,992,654 | 600,000 | ||||||||||||
Ending balance at Mar. 31, 2022 | $ 70 | $ 19,227 | 377,541 | (403,236) | (2,205) | (8,603) | ||||||||
Beginning balance (in shares) at Dec. 31, 2021 | 6,935,154 | 600,000 | ||||||||||||
Beginning balance at Dec. 31, 2021 | $ 69 | $ 19,227 | 377,229 | (397,281) | (1,849) | (2,605) | ||||||||
Net loss | (9,070) | |||||||||||||
Foreign currency translation adjustments | (1,279) | |||||||||||||
Ending balance (in shares) at Jun. 30, 2022 | 6,995,461 | 600,000 | ||||||||||||
Ending balance at Jun. 30, 2022 | $ 70 | $ 19,227 | 377,847 | (406,351) | (3,484) | (12,335) | ||||||||
Beginning balance (in shares) at Mar. 31, 2022 | 6,992,654 | 600,000 | ||||||||||||
Beginning balance at Mar. 31, 2022 | $ 70 | $ 19,227 | 377,541 | (403,236) | (2,205) | (8,603) | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 10,307 | |||||||||||||
Issuance of common stock, net of issuance costs | 39 | 39 | ||||||||||||
Forfeitures of restricted stock (in shares) | (7,500) | |||||||||||||
Stock-based compensation expense | 267 | 267 | ||||||||||||
Net loss | (3,115) | (3,115) | ||||||||||||
Foreign currency translation adjustments | (923) | (923) | ||||||||||||
Ending balance (in shares) at Jun. 30, 2022 | 6,995,461 | 600,000 | ||||||||||||
Ending balance at Jun. 30, 2022 | $ 70 | $ 19,227 | 377,847 | (406,351) | (3,484) | (12,335) | ||||||||
Beginning balance (in shares) at Dec. 31, 2022 | 6,995,513 | 600,000 | ||||||||||||
Beginning balance at Dec. 31, 2022 | $ 70 | $ 19,227 | 378,238 | (415,388) | (2,955) | (20,808) | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 597,000 | |||||||||||||
Issuance of common stock, net of issuance costs | $ 6 | (6) | ||||||||||||
Repurchase of stock (in shares) | (200,919) | (600,000) | ||||||||||||
Repurchase of stock | $ (2) | $ (19,227) | $ (312) | $ 18,289 | $ (314) | $ (938) | ||||||||
Issuance of Preferred stock - Series B (in shares) | 12,000 | |||||||||||||
Issuance of Preferred stock - Series B | $ 7,714 | $ 7,714 | ||||||||||||
Preferred stock dividends | $ 14 | (14) | ||||||||||||
Stock-based compensation expense | 226 | 226 | ||||||||||||
Net loss | (4,968) | (4,968) | ||||||||||||
Foreign currency translation adjustments | 172 | 172 | ||||||||||||
Ending balance (in shares) at Mar. 31, 2023 | 7,391,594 | 12,000 | ||||||||||||
Ending balance at Mar. 31, 2023 | $ 74 | $ 7,728 | 378,146 | (402,081) | (2,783) | (18,916) | ||||||||
Beginning balance (in shares) at Dec. 31, 2022 | 6,995,513 | 600,000 | ||||||||||||
Beginning balance at Dec. 31, 2022 | $ 70 | $ 19,227 | 378,238 | (415,388) | (2,955) | (20,808) | ||||||||
Net loss | (14,997) | |||||||||||||
Foreign currency translation adjustments | 172 | |||||||||||||
Ending balance (in shares) at Jun. 30, 2023 | 8,803,727 | 78,617 | ||||||||||||
Ending balance at Jun. 30, 2023 | $ 88 | $ 74,725 | 386,979 | (412,779) | (2,783) | 46,230 | ||||||||
Beginning balance (in shares) at Mar. 31, 2023 | 7,391,594 | 12,000 | ||||||||||||
Beginning balance at Mar. 31, 2023 | $ 74 | $ 7,728 | 378,146 | (402,081) | (2,783) | (18,916) | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,415,133 | |||||||||||||
Issuance of common stock, net of issuance costs | $ 14 | 34 | $ 48 | |||||||||||
Issuance of Preferred stock - Series B (in shares) | 66,617 | |||||||||||||
Issuance of Preferred stock - Series B | $ 66,328 | $ 2,355 | $ 68,683 | |||||||||||
Forfeitures of restricted stock (in shares) | (3,000) | |||||||||||||
Stock option exercises (in shares) | ||||||||||||||
Preferred stock dividends | $ 669 | (669) | ||||||||||||
Stock-based compensation expense | 217 | $ 217 | ||||||||||||
Forfeiture of common stock warrants | 6,227 | 6,227 | ||||||||||||
Net loss | (10,029) | (10,029) | ||||||||||||
Ending balance (in shares) at Jun. 30, 2023 | 8,803,727 | 78,617 | ||||||||||||
Ending balance at Jun. 30, 2023 | $ 88 | $ 74,725 | $ 386,979 | $ (412,779) | $ (2,783) | $ 46,230 |
Nature of Operations
Nature of Operations | 6 Months Ended |
Jun. 30, 2023 | |
Nature of Operations [Abstract] | |
Nature of Operations | 1. NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware. The Company presently focuses on diseases affecting the retina, because the Company believes these diseases are not well treated with current therapies and affect millions of people globally. The Company’s products are ILUVIEN ® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in 24 countries for the treatment of diabetic macular edema (DME), and YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the United States for the treatment and prevention of uveitis. 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 have a clinically significant rise in intraocular pressure. In 17 countries in Europe, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies. In addition, ILUVIEN has received marketing authorization in 17 European countries and reimbursement in ten countries for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment (NIU-PS). The Company markets ILUVIEN directly in the U.S., Germany, the 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 for the development and commercialization of the Company’s 0.19mg fluocinolone acetonide intravitreal injection in China, East Asia and the Western Pacific. As of June 30, 2023, the Company has recognized sales of ILUVIEN to its international distributors in the Middle East, China, Austria, Belgium, Czech Republic, France, Italy, Luxembourg, Spain, the Netherlands, and the Nordic Region. In the U.S., YUTIQ is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company has the rights to commercialize YUTIQ under a product rights agreement dated May 17, 2023 (the Product Rights Agreement) with EyePoint Pharmaceuticals, Inc. (EyePoint Parent) in the entire world, except Europe, the Middle East and Africa as the Company had previously licensed from EyePoint Pharmaceuticals US, Inc. (EyePoint) rights in those territories to certain products, which included YUTIQ (known as ILUVIEN® in Europe, the Middle East and Africa) for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment. (See Note 17) The Product Rights Agreement also excludes any rights to YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye in China and certain other countries and regions in Asia, which rights are subject to a pre-existing exclusive license between EyePoint Parent and Ocumension Therapeutics. |
Basis of Presentation
Basis of Presentation | 6 Months Ended |
Jun. 30, 2023 | |
Basis of Presentation [Abstract] | |
Basis of Presentation | 2. BASIS OF PRESENTATION 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-Q and Article 8-03 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, these Interim Financial Statements do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying Interim Financial Statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information. 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, 2022, and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the SEC on March 31, 2023 (the 2022 Form 10-K). The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2022. Certain of the Company’s more significant accounting policies adopted in the current year are as follows: Acquisition of Intangible Assets The Company accounts for the acquisition of pharmaceutical product licenses as an asset acquisition in accordance with FASB ASC 805 – Business Combinations (“ASC 805”). ASC 805 specifies that if substantially all of the fair value of the gross assets acquired in a transaction are concentrated in a single identifiable asset or group of similar identifiable assets, then the set is not a business and is recorded as an asset acquisition. Under this model, the Company assigns the cost of the transaction to the acquired tangible assets, to the identified intangible assets and liabilities and any above or below-market contracts. The purchase price, including the direct amounts paid for the net assets in the transaction and any acquisition costs incurred that relate directly to the acquisition, is assigned based on the relative fair values of the assets acquired and liabilities assumed. The fair value of any identified intangible assets is determined at the acquisition date based on inputs and other factors based on market participants. Adoption of New Accounting Standard In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (ASC 326): Measurement of Credit Losses on Financial Instruments . This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard became effective for the Company on January 1, 2023. The adoption of this ASU did not have a material impact on its financial statements. In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers. The amendments in this ASU require that an acquirer recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The amendments in this ASU are effective for fiscal years beginning after December 15, 2022, with early adoption permitted. The adoption of this ASU did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In March 2020, the FASB issued ASU 2020-04 , Reference Rate Reform (ASC 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting . This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard was available until December 31, 2022. In December 2022, the FASB issued ASU No. 2022-06 which extended the period of time preparers can utilize the reference rate reform relief guidance in Topic 848. The guidance ensures the relief in Topic 848 covers the period of time during which a significant number of modifications may take place and the ASU defers the sunset date of Topic 848 from December 31, 2022 to December 31, 2024. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2023 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 4. REVENUE RECOGNITION Overview The Company recognizes revenue when a customer obtains control of the related good or service. The amount recognized reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606 Revenue from Contracts with Customers , the Company performs the following steps as outlined in the guidance: (1) identify the contract with the customer, (2) identify the performance obligations within the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when the entity satisfies a performance obligation. At the inception of a contract, the contract is evaluated to determine if it falls within the scope of ASC 606, followed by the Company’s assessment of the goods or services promised within each contract, assessment of whether the promised good or service is distinct and determination of the performance obligations. The Company then recognizes revenue based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. 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 observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations. Net Product Sales The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). 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 for 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 net sales price (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 (MCOs), Group Purchasing Organizations (GPOs), 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 to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. With respect to the Company’s international contracts with third-party distributors, certain contracts have elements of variable consideration, and management reviews those contracts on a regular basis and makes estimates of revenue based on historical ordering patterns and known market events and data. The amount of variable consideration included in net sales in each period could vary depending on the terms of these contracts and the probability of reversal in future periods. 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 months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may, at its option, either refund the sales price paid by the Customer by issuing a credit or exchanging the returned product for replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. 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 be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. Through the date of this report, product returns have been minimal. 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 include payment to the Company of one or more of the following: non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. 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 observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations. 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. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the expected value method. As such, the Company assesses each milestone to determine the probability of and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event. 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 to 120 days. Occasionally, the Company offers extended payment terms or payment term discounts to certain Customers. Amounts are recorded as accounts receivable when the Company's right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services within one year or less of receiving those products or services. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Leases | 5. LEASES The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right of use assets and accounts for these, as applicable, at inception of the contract. Upon adoption of ASC 842 , the Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right of use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component. Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has determined it is not reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term. Operating Leases The Company’s operating lease activities primarily consist of leases for office space in the U.S., the U.K., Ireland, Portugal and Germany. Most of these leases include options to renew, with renewal terms generally ranging from one to eight years . The exercise of lease renewal options is at the Company’s sole discretion. Certain of the Company’s operating lease agreements include variable lease costs that are based on common area maintenance and property taxes. The Company expenses these payments as incurred. The Company’s operating lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of June 30, 2023 and December 31, 2022 for the Company’s operating leases is as follows: June 30, December 31, 2023 2022 (In thousands) NON-CURRENT ASSETS: Right of use assets, net $ 1,277 $ 1,395 Total lease assets $ 1,277 $ 1,395 CURRENT LIABILITIES: Accrued expenses $ 685 $ 768 NON-CURRENT LIABILITIES: Other non-current liabilities 2,029 2,267 Total lease liabilities $ 2,714 $ 3,035 The Company’s operating lease cost for the three and six months ended June 30, 2023 was $ 256,000 and $ 405,000 , respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations. The Company’s operating lease cost for the three and six months ended June 30, 2022 was $ 134,000 and $ 272,000 , respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations. As of June 30, 2023, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2023 (remaining) $ 354 2024 680 2025 474 2026 488 2027 503 Thereafter 1,052 Total 3,551 Less amount representing interest ( 837 ) Present value of minimum lease payments 2,714 Less current portion (as a portion of accrued expenses) ( 685 ) Non-current portion (as a portion of other non-current liabilities) $ 2,029 Cash paid for operating leases was $ 176,000 and $ 351,000 during the three and six months ended June 30, 2023, respectively. No right-of-use assets were obtained in connection with operating leases for the three and six months ended June 30, 2023. Cash paid for operating leases was $ 64,000 and $ 132,000 during the three and six months ended June 30, 2022, respectively. No right-of-use assets were obtained in connection with operating leases for the three and six months ended June 30, 2022. As of June 30, 2023, the weighted average remaining lease terms of the Company’s operating leases was 6.0 years. The weighted average discount rate used to determine the lease liabilities was 9.5 %. Finance Leases The Company’s finance lease activities primarily consist of leases for office equipment and 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 contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of June 30, 2023 and December 31, 2022 for the Company’s finance leases is as follows: June 30, December 31, 2023 2022 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 384 $ 366 Total lease assets $ 384 $ 366 CURRENT LIABILITIES: Finance lease obligations $ 203 $ 333 NON-CURRENT LIABILITIES: Other non-current liabilities 180 131 Total lease liabilities $ 383 $ 464 Depreciation expense associated with property and equipment under finance leases was approximately $ 71,000 and $ 65,000 for the three months ended June 30, 2023 and 2022, respectively. Depreciation expense associated with property and equipment under finance leases was approximately $ 123,000 and $ 155,000 for the six months ended June 30, 2023 and 2022, respectively. Interest expense associated with finance leases was $ 11,000 and $ 10,000 for the three months ended June 30, 2023 and 2022, respectively. Interest expense associated with finance leases was $ 22,000 and $ 21,000 for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows: Years Ending December 31 (In thousands) 2023 (remaining) $ 178 2024 177 2025 114 2026 15 Total 484 Less amount representing interest ( 101 ) Present value of minimum lease payments 383 Less current portion ( 203 ) Non-current portion $ 180 Cash paid for finance leases was $ 132,000 and $ 251,000 during the three and six months ended June 30, 2023, respectively. The Company acquired $ 80,000 and $ 170,000 of property and equipment in exchange for finance leases during the three and six months ended June 30, 2023, respectively. Cash paid for finance leases was $ 167,000 and $ 175,000 during the three and six months ended June 30, 2022, respectively. No property or equipment was obtained in exchange for finance leases during the three and six months ended June 30, 2022. As of June 30, 2023, the weighted average remaining lease terms of the Company’s finance leases was 0.8 years. The weighted average discount rate used to determine the finance lease liabilities was 9.9 %. |
Going Concern
Going Concern | 6 Months Ended |
Jun. 30, 2023 | |
Going Concern [Abstract] | |
Going Concern | 6. GOING CONCERN The accompanying Interim Financial Statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. The Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $412,779,000 from the Company’s inception through June 30, 2023. As of June 30, 2023, the Company had approximately $18,807,000 in cash and cash equivalents. The Company’s ability to achieve profitability and positive cash flow depends on its ability to increase revenue and contain its expenses. Further, the Company must maintain compliance with the debt covenants of its Loan and Security Agreement dated December 31, 2019 with SLR Investment Corp (SLR) and certain other lenders (as amended, the 2019 Loan Agreement). (See Note 10) If the Company were unable to comply with the Revenue Covenant (as defined in Note 10) at any time over the course of the next year, the lenders have the right to accelerate the maturity of the loan which would raise substantial doubt about the Company’s ability to continue as a going concern without access to alternative debt and/or equity financing, over the course of the next twelve months. To meet the Company’s anticipated future working capital needs, in March and May 2023, the Company consummated equity financings and amended the 2019 Loan Agreement (See Note 10). The Company may in the future need to raise additional debt and/or equity financing. The source, timing, and availability of any future financing will depend upon market conditions and other factors that may be outside of the Company’s control. Funding may not be available when needed, at all, or on terms acceptable to the Company. Because of these factors and the requirement to satisfy the Revenue Covenant and the Company’s history of recurring losses and negative cash flow from operations, there may be doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. However, the Company believes the current cash reserves and expected revenue from operations are sufficient to fund its operation for at least the next 12 months. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2023 | |
Inventory [Abstract] | |
Inventory | 7. INVENTORY Inventory consisted of the following: June 30, December 31, 2023 2022 (In thousands) Component parts (1) $ 505 $ 152 Work-in-process (2) 73 560 Finished goods 477 893 Total Inventory $ 1,055 $ 1,605 (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 EEA regulatory authorities. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2023 | |
Intangible Assets [Abstract] | |
Intangible Assets | 8. INTANGIBLE ASSETS ILUVIEN Intangible Asset As a result of the U.S. Food and Drug Administration’s (FDA) approval of ILUVIEN in September 2014, the Company was required to pay in October 2014 a milestone payment of $ 25,000,000 (the EyePoint Milestone Payment) to EyePoint, formerly known as pSivida US, Inc. (see Note 9). The gross carrying amount of the intangible asset is $ 25,000,000 , which is being amortized over approximately 13 years from the payment date. The amortization expense related to the intangible asset was approximately $ 484,000 for the three months ended June 30, 2023 and 2022, respectively. The amortization expense related to the intangible asset was approximately $ 962,000 for both the six months ended June 30, 2023 and 2022. The net book value of the intangible asset was $ 7,995,000 and $ 8,957,000 as of June 30, 2023 and December 31, 2022, respectively. The estimated remaining amortization as of June 30, 2023 is as follows (in thousands): Years Ending December 31 (In thousands) 2023 (remaining) $ 978 2024 1,946 2025 1,940 2026 1,940 2027 1,191 Total $ 7,995 YUTIQ Intangible Asset On May 17, 2023 the Company was granted an exclusive and sublicensable right and license, pursuant to the Product Rights Agreement to commercialize YUTIQ for the treatment and prevention of uveitis in the entire world, except Europe, the Middle East and Africa, excluding any rights for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye in China and certain other countries and regions in Asia, which rights are subject to a pre-existing exclusive license between EyePoint and Ocumension Therapeutics. As a result, the Company paid EyePoint Parent an upfront payment of $ 75,000,000 and will make four quarterly additional guaranteed payments to EyePoint Parent totaling $ 7,500,000 in 2024 as well as royalties in 2025 through 2028 (see Note 17). The gross carrying amount of the intangible asset is $ 98,122,000 , which is being amortized over approximately 10 years from the initial payment date. The amortization expense related to the intangible asset was approximately $ 1,182,000 for the three and six months ended June 30, 2023 . The net book value of the intangible asset was $ 96,940,000 as of June 30, 2023. The estimated remaining amortization as of June 30, 2023 is as follows (in thousands): Years Ending December 31 (In thousands) 2023 (remaining) $ 4,942 2024 9,831 2025 9,804 2026 9,804 2027 9,804 Thereafter 52,755 Total $ 96,940 |
License Agreements
License Agreements | 6 Months Ended |
Jun. 30, 2023 | |
License Agreements [Abstract] | |
License Agreements | 9. LICENSE AGREEMENTS EyePoint License Agreement In February 2005, the Company entered into an agreement with EyePoint (formerly known as pSivida US, Inc.) for the use of fluocinolone acetonide (FAc) in EyePoint’s proprietary insert technology. This agreement was subsequently amended a number of times (as amended, the EyePoint Agreement). The EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. In July 2017, the Company amended and restated its EyePoint license agreement, which was made effective July 1, 2017 (the New Collaboration Agreement). Under the New Collaboration Agreement, the Company has the right to the technology underlying ILUVIEN for the treatment of (a) human eye diseases, including uveitis, in Europe, the Middle East, and Africa, and (b) human eye diseases other than uveitis worldwide. The New Collaboration Agreement converted the Company’s previous profit share obligation to a royalty payable on global net revenues of ILUVIEN. Following the signing of the New Collaboration Agreement, the Company retained a right to recover up to $ 15,000,000 of commercialization costs that were incurred prior to profitability of ILUVIEN and to offset a portion of future payments owed to EyePoint with these accumulated commercialization costs, referred to as the Future Offset. Due to the uncertainty of future net profits, the Company has fully reserved the Future Offset in the accompanying Interim Financial Statements. In March 2019, pursuant to the New Collaboration Agreement, the Company forgave $ 5,000,000 of the Future Offset in connection with the approval of ILUVIEN for NIU-PS in the U.K. As of June 30, 2023, the balance of the Future Offset was approximately $ 6,762,000 , which is fully reserved. During the three and six months ended June 30, 2023 and 2022, the Company’s net royalty expense payable to EyePoint was 5.2 %, which was reduced from 6 % due to the recoverable balance of the Future Offset. The Company will be required to pay an additional 2 % royalty on future global net revenues and other related consideration in excess of $ 75,000,000 in any year. During the three and six months ended June 30, 2023, the Company recognized approximately $ 463,000 and $ 857,000 , respectively, of royalty expense, which is included in cost of goods sold, excluding depreciation and amortization. As of June 30, 2023, approximately $ 857,000 of this royalty expense was included in the Company’s accounts payable. During the three and six months ended June 30, 2022, the Company recognized approximately $ 758,000 and $ 1,375,000 , respectively, of royalty expense which is included in cost of goods sold, excluding depreciation and amortization. Ocumension License Agreement On April 14, 2021, the Company entered into an exclusive license agreement (the License Agreement) with Ocumension (Hong Kong) Limited (Ocumension HK), a wholly owned subsidiary of Ocumension Therapeutics, for the development and commercialization under Ocumension HK’s own brand name(s), either directly or through its affiliates or approved third-party sublicensees, of the Company’s 0.19 mg fluocinolone acetonide intravitreal implant in applicator (the Product; currently marketed in the United States, Europe, and the Middle East as ILUVIEN®) for the treatment and prevention of eye diseases in humans, other than uveitis, in a specified territory. The Territory is defined as the People’s Republic of China, including Hong Kong SAR and Macau SAR, region of Taiwan, South Korea, Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. The Company received a nonrefundable upfront payment of $ 10,000,000 from Ocumension HK and may in the future receive additional sales-based milestone payments totaling up to $ 89,000,000 upon the achievement by Ocumension HK of certain specified sales milestones during the term of the License Agreement. The Company’s receipt of future milestone payments depends upon whether Ocumension HK is able to successfully complete product development and commercialization in the Territory, which requires, among other things, obtaining necessary regulatory approvals and appropriate reimbursement pricing in the various countries and jurisdictions in the Territory, a process that may take several years. In 2021 the Company recognized $ 11,048,000 in license revenue from the Ocumension transaction (including the value of a warrant subscription agreement, which Alimera received as consideration, for Alimera to purchase 1,000,000 shares of Ocumension Therapeutics during a period of four years ), in accordance with ASC 606, Revenue from Contracts with Customers, with the remaining approximate $ 300,000 in consideration classified as deferred revenue that will be recognized over the remaining term of the license agreement once Ocumension begins to sell products. The term of the License will continue (a) until the 10th anniversary of the latest first commercial sale of the Product in any country or jurisdiction in the Territory or (b) for as long as Ocumension HK is commercializing the Product in any part of the Territory, whichever is later. The term is subject to the Company’s right to partially terminate the Agreement beginning on the 10th anniversary of the effective date with respect to any country or jurisdiction in the Territory in which Ocumension has not achieved at the time of termination first commercial sale and is not continuing to commercialize the Product. Ocumension will purchase Product from the Company at a fixed transfer price without royalty obligation on future sale (other than milestone payments as described above). Ocumension HK is responsible for all costs of development and commercialization in the Territory . When the Company entered into the license agreement, it also entered into a share purchase agreement and a warrant subscription agreement, which are discussed in Note 16. |
Loan Agreements
Loan Agreements | 6 Months Ended |
Jun. 30, 2023 | |
Loan Agreements [Abstract] | |
Loan Agreements | 10. LOAN AGREEMENTS Loan Agreements with SLR Investment Corp. On January 5, 2018, the Company entered into a $ 40,000,000 loan and security agreement with Solar Capital Ltd., as Collateral Agent, and the parties signatory thereto from time to time as Lenders, including Solar Capital Ltd. in its capacity as a Lender (the 2018 Loan Agreement). On December 31, 2019, the Company refinanced the 2018 Loan Agreement by entering into a $ 45,000,000 loan and security agreement (the 2019 Loan Agreement) with SLR Investment Corp. (SLR, f/k/a Solar Capital Ltd.), as Agent, and the parties signing the Loan Agreement from time to time as Lenders, including SLR in its capacity as a Lender (collectively, the Lenders). The Company amended the 2019 Loan Agreement on March 24, 2023 (the Fifth Amendment) and entered into a related exit fee agreement with the Lenders. (See Note 21) Pursuant to the Fifth Amendment, the Lenders agreed to, among other things, (i) an additional tranche of $ 2,500,000 to increase the Company’s existing term loan facility to $ 47,500,000 , subject to certain closing conditions, and (ii) extend a $ 15,000,000 additional term loan available to be funded at the Lender’s sole discretion. Interest on the 2019 Loan Agreement prior to the Fifth Amendment was payable at an annual rate the greater of (i) one-month LIBOR or (ii) 1.78 %, plus 7.65 % per annum. Interest on the 2019 Loan Agreement following the Fifth Amendment is payable at an annual rate equal to 5.15 % plus the greater of (i) 4.60 % and (ii) one-month SOFR, which will reset monthly. As of March 31, 2023, the interest rate on the 2019 Loan Agreement was approximately 9.75 %. The 2019 Loan Agreement provides for interest only payments until April 30, 2025, which may be extended an additional 12 months if the Company meets certain financial targets by March 31, 2025, followed by monthly payments of principal and interest through the loan maturity date of April 30, 2028. 2018 Exit Fee Agreement Notwithstanding the repayment of the outstanding loan under the 2018 Loan Agreement, the Company remains obligated to pay additional fees under the Exit Fee Agreement (2018 Exit Fee Agreement) dated as of January 5, 2018 by and among the Company, SLR, as Agent, and the Lenders. The 2018 Exit Fee Agreement survived the termination of the 2018 Loan Agreement upon the repayment of the outstanding loan under the 2018 Loan Agreement and has a term of 10 years. The Company is obligated to pay up to, but no more than, $ 2,000,000 in fees under the 2018 Exit Fee Agreement. Specifically, the Company is obligated to pay an exit fee of $ 2,000,000 on a “change in control” (as defined in the 2018 Exit Fee Agreement). To the extent that the Company has not already paid the $ 2,000,000 fee, the Company is also obligated to pay a fee of $ 1,000,000 on achieving each of the following milestones: first, if the Company achieves revenues of $ 80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12 -month basis during the term of the agreement, tested at the end of each month; and second, if the Company achieves revenues of $ 100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner. 2019 Exit Fee Agreement The Company is also obligated to pay additional fees under the Exit Fee Agreement dated as of December 31, 2019 by and among the Company, SLR as Agent, and the Lenders (2019 Exit Fee Agreement). The 2019 Exit Fee Agreement will survive the termination of the 2019 Loan Agreement and has a term of 10 years. The Company will be obligated to pay a $ 675,000 exit fee upon the occurrence of an exit event, which generally means a change in control, as defined in the 2019 Exit Fee Agreement. 2023 Exit Fee Agreement On March 24, 2023, the Company entered into the Fifth Amendment Exit Fee Agreement (the New Exit Fee Agreement), which will survive the termination of the Amended Loan Agreement and has a term of 10 years. The Company will be obligated to pay an exit fee of 1.5 % of the original principal amount funded under the Amended Loan Agreement upon the occurrence of an exit event, which generally means a change in control, as defined in the New Exit Fee Agreement. If the Company has not already paid the exit fee under the New Exit Fee Agreement, the Company is also obligated to pay an equivalent fee upon achieving revenues of $ 82,500,000 or more from the sale of ILUVIEN in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the New Exit Fee Agreement, tested at the end of each month. The Company’s existing 2015 and 2019 Exit Fee Agreements remain in effect. The fees payable pursuant to the Company’s existing exit fee agreements and the New Exit Fee Agreement, as amended by the Omnibus Amendment to Exit Fee Agreements dated as of May 17, 2023, will not exceed $3,387,500 in total. Third Amendment to 2019 Loan Agreement On February 22, 2022, the Company entered into a Third Amendment to the 2019 Loan Agreement (the Third Amendment), which, among other things: (a) specified the minimum revenue amount, calculated on a trailing six-month basis and tested at the end of each calendar quarter in 2022, that the Company must achieve for each such period (the Third Amendment Revenue Covenant); (b) consented to the Company maintaining a lower minimum revenue amount under the Third Amendment Revenue Covenant for the trailing six-month period ended December 31, 2021 than previously required under the Loan Agreement (and waived any event of default that may have occurred or may be deemed to have occurred as a result of the Company’s lower revenue amount for that period); and (c) required that the Third Amendment Revenue Covenant be tested at March 31, 2023 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of the Company’s projected revenues in accordance with an annual plan submitted by the Company to the Collateral Agent by January 15 of such year, such plan to be thereafter approved by the Company’s board of directors and the Collateral Agent in its sole discretion no later than February 28 of such year. Fourth Amendment to 2019 Loan Agreement On December 7, 2022, the Company entered into a Fourth Amendment to the 2019 Loan Agreement (the Fourth Amendment), which, among other things: (a) extends the amortization date from January 1, 2023 to April 1, 2023, provided that such date may be further extended to July 1, 2023 upon the Company’s request and in consultation with the Lenders, in each of the Lenders’ sole discretion; (b) specifies the minimum revenue amount, calculated on a trailing six-month basis and tested at the end of each calendar quarter in 2023, that the Company must achieve for each such period (the Fourth Amendment Revenue Covenant); and (c) requires that the Fourth Amendment Revenue Covenant be tested at March 31, 2023 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of Alimera’s projected revenues in accordance with an annual plan submitted by the Company to the Collateral Agent by January 15th of such year, such plan to be thereafter approved by Alimera’s board of directors and the Collateral Agent in its sole discretion no later than February 28 of such year. Fifth Amendment to 2019 Loan Agreement On March 24, 2023, the Company entered into a Fifth Amendment to the 2019 Loan Agreement (the Fifth Amendment), under which the Lenders agreed to, among other things: (a) a n additional tranche of $ 2,500,000 to increase the Company’s existing term loan facility to $ 47,500,000 , subject to certain closing conditions (the New Term Loan) ; (b) extend a $ 15,000,000 additional term loan available to be funded at the Lender’s sole discretion; (c) annual interest rate equal to 5.15 % plus the greater of (i) 4.60 %, and (ii) one-month SOFR, which will reset monthly, on the New Term Loan; (d) extend the maturity date to April 30, 2028 and the interest-only period to April 30, 2025, which may be extended an additional 12 months if the Company meets certain financial targets by March 31, 2025; and (e) specify the minimum revenue amount, calculated on a trailing six month basis beginning with the six month period ended March 31, 2023, and tested at the end of each calendar quarter, that the Company must achieve for each such period. Sixth Amendment to 2019 Loan Agreement On May 17, 2023, the Company entered into a Sixth Amendment to the 2019 Loan Agreement (the Sixth Amendment and the 2019 Loan Agreement as so amended, the Amended Loan Agreement), under which the Lenders agreed to, among other things: (a) increase the amount available for an additional term loan under the facility from $ 15,000,000 to $ 20,000,000 ; (b) fund the full amount of the additional term loan on May 17, 2023; and (c) specify the minimum revenue amount, calculated on a trailing six -month basis and tested at the end of each calendar quarter in 2023 and 2024, that the Company must achieve for each such period (the Revenue Covenant). The Company complied with the Revenue Covenant on June 30, 2023, expects to comply with the Revenue Covenant at the next reportable date, which is September 30, 2023, and the remainder of the Revenue Covenants through one year after these financial statements are issued. Modification of Debt In accordance with the guidance in ASC 470-50, Debt , the Company entered into and accounted for the Third Amendment, Fourth Amendment, and Fifth Amendment as modifications and expensed, as they were incurred, legal costs associated with third parties as costs of the modifications. The Company capitalized $ 113,000 of costs in connection with the Fourth Amendment. The Company did not capitalize any costs associated with the Third Amendment. The Company capitalized $ 2,625,000 of costs in connection with the Fifth Amendment. Extinguishment of Debt In accordance with the guidance in ASC 470-50, Debt , the Company entered into and accounted for the Sixth Amendment as an extinguishment of debt. The Company recognized a loss on extinguishment of $ 1,079,000 in connection with the Sixth Amendment. 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, 2023 and December 31, 2022. |
Loss Per Share (EPS)
Loss Per Share (EPS) | 6 Months Ended |
Jun. 30, 2023 | |
Loss Per Share (EPS) [Abstract] | |
Loss Per Share (EPS) | 11. LOSS PER SHARE (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. However, the Company’s preferred stockholders are not contractually obligated to share in losses. On August 1, 2023, the Company’s stockholders approved the issuance of shares of common stock upon conversion of the Series B Preferred and the issuance of shares of common stock upon exercise of certain warrants. The Company set August 15, 2023 as the date for the Mandatory Conversion (as defined in Note 19). Basic EPS is computed by dividing net income or loss available to stockholders by the weighted average number of shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options and warrants the Company has issued. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either not classified as participating or would have been anti-dilutive, were as follows: June 30, 2023 2022 Series A convertible preferred stock — 601,504 Series B convertible preferred stock 45,272,874 — Common stock warrants 1,600,000 — Stock options 1,217,045 1,310,465 Total 48,089,919 1,911,969 |
Preferred Stock
Preferred Stock | 6 Months Ended |
Jun. 30, 2023 | |
Preferred Stock [Abstract] | |
Preferred Stock | 12. PREFERRED STOCK Securities Purchase Agreement On March 24, 2023, the Company entered into a Securities Purchase Agreement (the Purchase Agreement) with certain investors (the Original Investors) for the sale of up to 27,000 shares of the Company’s newly designated Series B Convertible Preferred Stock, par value $ 0.01 per share (the Series B Preferred Stock) and warrants (the Warrants) to purchase up to 5,714,286 shares of the Company’s common stock, for an aggregate purchase price of $ 12,000,000 . On March 24, 2023 (the Tranche 1 Closing Date), the Company issued and sold an aggregate of 12,000 shares of Series B Preferred Stock at a per-share purchase price of $ 1,000 (the Stated Value) and the Warrants for aggregate gross proceeds of $ 12,000,000 (the Tranche 1 Closing). The proceeds from the Tranche 1 Closing were used to fund development and commercialization of the Company’s existing and potential future pipeline drugs, maintenance of the Company’s credit facility and corporate purposes substantially related to the commercialization of the Company’s existing and pipeline drugs, as well as the Repurchase (as defined below). The initial conversion price of the shares of Series B Preferred Stock issued at the Tranche 1 Closing is $ 2.10 (the Tranche 1 Conversion Price). The conversion price of the Series B Preferred Stock is subject to certain customary adjustments, including a weighted average anti-dilution adjustment. Unless and until stockholder approval to issue the common stock underlying the Series B Preferred Stock is obtained (Stockholder Approval), the Series B Preferred Stock will not be convertible into common stock to the extent that such conversion would cause (i) the aggregate number of shares of common stock that would be issued pursuant to the Purchase Agreement and the transactions contemplated thereby to exceed 1,401,901 ( 19.99 % of the voting power or number of shares of common stock, issued and outstanding immediately prior to the execution of the Purchase Agreement), which number will be reduced, on a share-for-share basis, by the number of shares of common stock issued or issuable pursuant to any transactions that may be aggregated with the transactions contemplated by the Purchase Agreement under applicable Nasdaq rules (the Exchange Cap); or (ii) the aggregate number of shares of common stock that would be issued pursuant to such conversion, when aggregated with any shares of common stock then beneficially owned by the holder (or group of holders required to be aggregated) of such shares, would result in (a) a “change of control” under applicable Nasdaq listing rules (the Change of Control Cap) or (b) such holder or a “person” or “group” to beneficially own in excess of 9.99 % of the common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon such conversion (the Ownership Limitation). The Series B Preferred Stock will be entitled to receive dividends and other distributions pro rata with the common stock. In addition, prior to conversion, dividends will accrue on the Series B Preferred Stock at an annual rate of 6 % of the Stated Value, accruing daily. The Series B Preferred Stock is not redeemable. The Warrants have an exercise price equal to the Tranche 1 Conversion Price (as adjusted pursuant to the Certificate of Designation of the Series B Preferred Stock through the date of Stockholder Approval) and expire seven years from the date of the Tranche 1 Closing. The Warrants are exercisable upon the earlier of (a) a change of control and (b) March 24, 2024; provided that prior to Stockholder Approval, exercise of the Warrants is subject to the Ownership Limitation, the Change of Control Cap and the Exchange Cap. Joinder and Amendment to Securities Purchase Agreement On May 17, 2023, Alimera entered into a joinder and amendment (the Purchase Agreement Amendment) to the Purchase Agreement. The Purchase Agreement Amendment added certain investors as parties to the Purchase Agreement with respect to the Tranche 2 Closing (as defined below) and amended certain provisions of the Purchase Agreement. Pursuant to the amended Purchase Agreement, on May 17, 2023, the Company issued 66,617 shares of Series B Preferred at the Stated Value and 1,401,901 shares of common stock, for aggregate gross proceeds of $ 69.0 million (the Tranche 2 Closing). The initial conversion price of the shares of Series B Preferred issued at the Tranche 2 Closing was $ 1.70 . Further, pursuant to the terms of the Purchase Agreement Amendment, the Company and the Original Investors agreed to reduce the number of shares of common stock issuable upon exercise of the Warrants to 1,600,000 . The proceeds from the Tranche 2 Closing were utilized by Alimera to fund a portion of the upfront cash payment due upon execution of the Product Rights Agreement. At June 30, 2023, the Series B Preferred Stock had $ 683,000 of cumulative dividends in arrears ($ 5.00 per share). On August 1, 2023, the Company received Stockholder Approval (see Note 19). Series A Convertible Preferred Stock In October 2012, the Company closed its preferred stock financing in which it sold units consisting of 1,000,000 shares of Series A Convertible Preferred Stock (Series A Preferred Stock) and warrants (which expired on October 1, 2017) to purchase 300,000 shares of Series A Preferred Stock for gross proceeds of $ 40,000,000 , prior to the payment of approximately $ 560,000 of related issuance costs. The powers, preferences and rights of the Series A Preferred Stock are set forth in the certificate of designation for the Series A Preferred Stock filed by the Company with the Delaware Secretary of State as part of the Company’s certificate of incorporation. As of December 31, 2022, there were 600,000 shares of Series A Convertible Preferred Stock issued and outstanding. As a condition to entering into the Purchase Agreement, the Company repurchased 200,919 shares of common stock and 600,000 shares of its Series A Preferred Stock held by the holders thereof (the Repurchase), for an aggregate purchase price of approximately $ 1,252,000 . The holders of the Series A Preferred Stock were entitled to a liquidation preference before the holders of common stock would be entitled to receive any consideration in the event of the Company’s liquidation. As of December 31, 2022, the Series A Preferred Stock aggregate liquidation preference was $ 24,000,000 . As a result of the Repurchase, no shares of the Series A Preferred Stock remain outstanding and the liquidation preference is no longer in effect. Following the Repurchase, the Company filed a certificate of elimination of the Series A Preferred Stock with the Secretary of State of the State of Delaware. |
Equity Incentive Plans
Equity Incentive Plans | 6 Months Ended |
Jun. 30, 2023 | |
Equity Incentive Plans [Abstract] | |
Equity Incentive Plans | 13. EQUITY INCENTIVE PLANS Under the Company’s 2019 Omnibus Incentive Plan (the 2019 Plan), the Compensation Committee of the Board is authorized to grant equity-based incentive awards that include stock options, restricted stock units and shares of restricted stock to officers, directors, employees and contractors. Equity-based awards are also outstanding under the Company’s 2010 Equity Incentive Plan, although no new awards can be granted under that plan. The Company also has an employee stock purchase plan. Stock Options During the three months ended June 30, 2023 and 2022, the Company recorded compensation expense related to stock options of approximately $ 148,000 and $ 218,000 , respectively. During the six months ended June 30, 2023 and 2022, the Company recorded compensation expense related to stock options of approximately $ 315,000 and $ 476,000 , respectively. As of June 30, 2023, the total unrecognized compensation cost related to non-vested stock options granted was $ 895,000 and is expected to be recognized over a weighted average period of 2.3 years. The following table presents a summary of stock option activity for the three months ended June 30, 2023 and 2022: Three Months Ended June 30, 2023 2022 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,216,953 18.03 1,315,161 19.39 Grants 17,321 2.55 1,700 4.34 Forfeitures and expirations ( 17,229 ) 45.18 ( 6,396 ) 15.58 Exercises — — — — Options outstanding at period end 1,217,045 17.43 1,310,465 19.39 Options exercisable at period end 893,401 22.07 887,543 25.91 Weighted average per share fair value of options granted during the period $ 1.77 $ 2.94 The following table presents a summary of stock option activity for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 2022 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,175,339 19.03 1,075,795 23.35 Grants 117,723 2.70 285,250 4.96 Forfeitures and expirations ( 76,017 ) 19.41 ( 50,580 ) 21.51 Exercises — — — — Options outstanding at period end 1,217,045 17.43 1,310,465 19.39 Options exercisable at period end 893,401 22.07 887,543 25.91 Weighted average per share fair value of options granted during the period $ 1.86 $ 3.32 The following table provides additional information related to outstanding stock options as of June 30, 2023: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,217,045 17.43 5.57 years 24 Exercisable 893,401 22.07 4.50 years 7 Outstanding, vested and expected to vest 1,182,115 17.81 5.48 years 22 The following table provides additional information related to outstanding stock options as of December 31, 2022: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,175,339 19.03 5.68 years — Exercisable 878,115 23.62 4.72 years — Outstanding, vested and expected to vest 1,139,482 19.46 5.58 years — As of June 30, 2023, 52,283 shares remain available for grant under the 2019 Plan. On August 1, 2023, the Company’s stockholders approved the Alimera Sciences, Inc. 2023 Equity Incentive Plan (Note 19). Restricted Stock and Restricted Stock Units (RSUs) The following table presents a summary of restricted stock and RSU activity for the three months ended June 30, 2023 and 2022: Three Months Ended June 30, 2023 2022 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 685,176 1.67 94,063 5.29 Grants — — — — Vested restricted stock and RSUs — — ( 7,500 ) 8.93 Forfeitures ( 3,000 ) 1.35 — — Restricted stock and RSUs outstanding at period end 682,176 1.67 86,563 4.98 The following table presents a summary of restricted stock and RSU activity for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 2022 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 73,594 4.98 46,250 5.65 Grants 632,050 1.39 57,500 4.96 Vested restricted stock and RSUs ( 20,468 ) 4.98 ( 9,687 ) 5.01 Forfeitures ( 3,000 ) 1.35 ( 7,500 ) 8.93 Restricted stock and RSUs outstanding at period end 682,176 1.67 86,563 4.98 Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation (ASC 718) was $ 62,000 and $ 43,000 for the three months ended June 30, 2023 and 2022, respectively. Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation (ASC 718) was $ 109,000 and $ 89,000 for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, the total unrecognized compensation cost related to restricted stock and RSUs was $ 1,120,000 and is expected to be recognized over a weighted average period of 3.62 years. Employee Stock Purchase Plan During each of the three months ended June 30, 2023 and 2022, the Company recorded compensation expense related to its employee stock purchase plan of approximately $ 7,000 . During the six months ended June 30, 2023 and 2022, the Company recorded compensation expense related to its employee stock purchase plan of approximately $ 18,000 , and $ 15,000 , respectively. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Taxes [Abstract] | |
Income Taxes | 14. INCOME TAXES In accordance with ASC 740, Income Taxes, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. 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 change to the Company’s policy that recognizes potential interest and penalties related to uncertain tax positions. The Company conducts business globally and, as a result, files income tax returns in the U.S. federal jurisdiction and various state and foreign jurisdictions. In the normal course of business, the Company is subject to examination by taxing authorities throughout the world. For the six months ended June 30, 2023, the Company has not recorded income tax expense or benefit. No tax benefit is expected to be realized for the losses in the United States and the United Kingdom due to the ongoing losses and valuation allowances in these jurisdictions. Tax expense or benefit for income and losses in other jurisdictions (Ireland, Germany, and Portugal) are immaterial for the period. At December 31, 2022, the Company had U.S. federal NOL carry-forwards of approximately $ 147,200,000 and state NOL carry-forwards of approximately $ 107,700,000 available to reduce future taxable income, subject to limitation based upon the results of the Company’s analyses under Internal Revenue Code Sections 382 and 383. The Company’s U.S. federal NOL carry-forwards remain fully reserved as of June 30, 2023. If not utilized, the federal NOL carry-forwards will expire at various dates between 2029 and 2037, the Company’s federal NOL created in 2018 and onward will carry forward indefinitely and the state NOL carry-forwards will expire at various dates between 2023 and 2042. NOL carry-forwards may be subject to annual limitations under Internal Revenue Code Sections 382 and 383 in the event that certain changes in ownership of the Company were to occur. The Company has not yet completed a formal evaluation of the impact of the issuance of the Company’s Series B Preferred Stock in March and May of 2023 on the Company’s NOL carry-forwards and whether certain changes in ownership have occurred that would limit the Company’s ability to utilize a portion of its NOL carry-forwards. As of December 31, 2022, the Company’s U.K. subsidiary is in a net deferred tax asset position primarily due to the step up in tax basis for intangible assets created by the transfer of intellectual property from the Netherlands to the U.K. Based upon the expected pattern of reversal of deferred taxes, it is not more likely than not that these deferred tax assets will be realized. As such, a full valuation allowance is placed against the net deferred tax assets of the U.K. subsidiary. The Company’s Irish subsidiary has a deferred tax asset for net operating loss carryforwards. The Company expects this net operating loss carryforward to be fully realizable in the future based upon the Company’s control of the transfer pricing arrangements. A valuation allowance is not recorded on the deferred tax assets of the Ireland subsidiary. Deferred tax considerations for all other foreign entities are immaterial to the financial statements. Effective January 1, 2022, for U.S. tax purposes research and development costs, including software development costs, are required to be capitalized and will be deductible over five years for costs incurred domestically and over fifteen years for costs incurred in a foreign country. Additionally, the first year of amortization requires that amortization begin with the midpoint of the taxable year. As of December 31, 2022, the Company recorded a deferred tax asset of approximately $ 969,000 related to capitalized research and development costs. This deferred tax asset is fully reserved with a valuation allowance. On August 16, 2022, the President of the United States signed the Inflation Reduction Act (IRA) into law. The IRA enacted a 15% corporate minimum tax effective in 2024, a 1% tax on share repurchases after December 31, 2022, and created and extended certain tax-related energy incentives. The Company does not currently expect the tax-related provisions of the IRA to have a material effect on its financial results. 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 expect to record deferred tax liabilities in the future related to excesses of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25. Tax years from 2018 to 2020 remain subject to examination in California, Georgia, Kentucky, Tennessee, Texas and on the federal level, with the exception of the assessment of NOL carry-forwards available for utilization, which can be examined for all years since 2009. The statute of limitations on these years will close when the NOLs expire or when the statute closes on the years in which the NOLs are utilized. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2023 | |
Segment Information [Abstract] | |
Segment Information | 15. SEGMENT INFORMATION During the three months ended June 30, 2023 and 2022, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 68 % and 61 % of the Company’s consolidated product revenues, respectively. During the six months ended June 30, 2023 and 2022, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 63 % and 60 % of the Company’s consolidated product revenues, respectively. These same two customers within the U.S. segment accounted for approximately 71 % of the Company’s consolidated accounts receivable at June 30, 2023 and at December 31, 2022 The Chief Executive Officer (CEO), who is the Company’s chief operating decision maker, has determined that the Company’s operations are managed as three operating segments: U.S., International and Operating Cost. The Company determined that each of these operating segments represented a reportable segment. In monitoring performance, aligning strategies and allocating resources, the chief operating decision maker manages and evaluates the Company’s U.S., International and Operating Cost segments based on segment income or loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. Therefore, the Company classifies within Other (a) the non-cash expenses included in research, development and medical affairs expenses; general and administrative expenses; and sales and marketing expenses; and (b) depreciation and amortization. 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 specifically associated with the U.S. or International segments and includes expenses such as executive management; information technology administration and support; legal; compliance; clinical studies; and business development. 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 report balance sheet information by segment because the chief operating decision maker does not review that information. The Company allocates certain operating expenses among its reporting segments based on activity-based costing methods. These activity-based costing methods require the Company to make estimates that affect the amount of each expense category that is attributed to each segment. Changes in these estimates will directly affect the amount of expense allocated to each segment and therefore the operating profit of each reporting segment. The following tables present a summary of the Company’s reporting segments for the three months ended June 30, 2023 and 2022: Three Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 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 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 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 ) Three Months Ended June 30, 2022 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 8,943 $ 5,661 $ — $ — $ 14,604 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,060 ) ( 1,106 ) — — ( 2,166 ) GROSS PROFIT 7,883 4,555 — — 12,438 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,281 807 1,799 45 3,932 GENERAL AND ADMINISTRATIVE EXPENSES 195 468 2,112 170 2,945 SALES AND MARKETING EXPENSES 4,568 2,112 133 52 6,865 DEPRECIATION AND AMORTIZATION — — — 670 670 OPERATING EXPENSES 6,044 3,387 4,044 937 14,412 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,839 1,168 ( 4,044 ) ( 937 ) ( 1,974 ) OTHER INCOME AND EXPENSES, NET — — — ( 1,124 ) ( 1,124 ) NET LOSS BEFORE TAXES $ ( 3,098 ) The following tables present a summary of the Company’s reporting segments for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 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 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 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 ) Six Months Ended June 30, 2022 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 15,863 $ 10,639 $ — $ — $ 26,502 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,875 ) ( 1,971 ) — — ( 3,846 ) GROSS PROFIT 13,988 8,668 — — 22,656 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,451 1,723 3,259 82 7,515 GENERAL AND ADMINISTRATIVE EXPENSES 511 892 4,393 389 6,185 SALES AND MARKETING EXPENSES 9,242 4,116 250 110 13,718 DEPRECIATION AND AMORTIZATION — — — 1,359 1,359 OPERATING EXPENSES 12,204 6,731 7,902 1,940 28,777 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,784 1,937 ( 7,902 ) ( 1,940 ) ( 6,121 ) OTHER INCOME AND EXPENSES, NET — — — ( 2,932 ) ( 2,932 ) NET INCOME BEFORE TAXES $ ( 9,053 ) |
Other Agreements with Ocumensio
Other Agreements with Ocumension | 6 Months Ended |
Jun. 30, 2023 | |
Other Agreements with Ocumension [Abstract] | |
Other Agreements with Ocumension | 16. OTHER AGREEMENTS WITH OCUMENSION Share Purchase Agreement On April 14, 2021, the Company entered into a Share Purchase Agreement with Ocumension Therapeutics, pursuant to which the Company offered and sold to Ocumension 1,144,945 shares of common stock (the Shares), at a purchase price of $ 8.734044 per Share. The number of Shares sold was equal to 19.9 % of the number of shares of common stock outstanding immediately before the closing. The aggregate gross proceeds from the sale of the Shares were $ 10,000,000 . The Company has used the net proceeds from the sale of the Shares to continue to commercialize ILUVIEN® and for general corporate purposes, which may include working capital, capital expenditures, other clinical trial expenditures, acquisitions of new technologies, products or businesses in ophthalmology, and investments. Ocumension is entitled to certain purchase rights if the Company elects to offer or sell new securities in either a private or public offering. Warrant Subscription Agreement On April 14, 2021, the Company entered into a warrant agreement with Ocumension Therapeutics pursuant to which Ocumension agreed to issue to the Company 1,000,000 non-transferable warrants granting the Company the right for a period of four years to subscribe to up to an aggregate of 1,000,000 shares of Ocumension stock at the subscription price of HK$ 23.88 per warrant share (or US$ 3.07 per warrant share as converted to U.S. Dollars at the exchange rate on April 9, 2021 of 0.12853 U.S. Dollars per HK$), subject to adjustment. (The converted rate is for illustrative purposes only; if the Company exercises the warrants, it will pay the subscription price of HK$ 23.88 per warrant share in HK$.) The warrants were issued on August 13, 2021, pursuant to the terms of the warrant agreement. The warrants are not and will not be listed on any stock exchange. |
Other Agreements with Eyepoint
Other Agreements with Eyepoint Parent and Eyepoint | 6 Months Ended |
Jun. 30, 2023 | |
Other Agreements with Eyepoint Parent and Eyepoint [Abstract] | |
Other Agreements with Eyepoint Parent and Eyepoint | 17. OTHER AGREEMENTS WITH EYEPOINT PARENT AND EYEPOINT Product Rights Agreement On May 17, 2023 the Company entered into the Product Rights Agreement with EyePoint Parent whereby the Company was granted an exclusive and sublicensable (in accordance with the terms of the Product Rights Agreement) right and license (the License) certain of EyePoint Parent’s and its affiliates’ intellectual property to develop, manufacture, sell, commercialize and otherwise exploit certain products, including YUTIQ for the treatment and prevention of uveitis in the entire world, except Europe, the Middle East and Africa. The License also excludes any rights to YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye in China and certain other countries and regions in Asia, which rights are subject to a pre-existing exclusive license between EyePoint and Ocumension Therapeutics. Additionally, pursuant to the Product Rights Agreement, EyePoint Parent will transfer and assign to the Company certain assets and certain contracts with third parties related to YUTIQ, including the new drug application #210331 for YUTIQ. As a result, the Company paid EyePoint Parent an upfront payment of $ 75,000,000 and will make four quarterly guaranteed payments to EyePoint Parent totaling $ 7,500,000 in 2024. The Company will also pay royalties to EyePoint Parent from 2025 to 2028 at a percentage of mid-to-low double digits of the Company’s annual U.S. net sales of certain products (including YUTIQ and ILUVIEN) in excess of certain thresholds, beginning at $ 70,000,000 in 2025, increasing annually thereafter. Upon the Company’s payment of the upfront payment and the guaranteed payments, the licenses and rights granted to the Company will automatically become perpetual and irrevocable. The Company also entered into a transition services agreement with EyePoint Parent under which EyePoint Parent has agreed to temporarily provide certain transition services to the Company on a cost-plus pricing arrangement following the closing date. The total purchase consideration was $ 98,122,000 , which has been recorded as an intangible asset, and includes the upfront payment of $ 75,000,000 as well as the guaranteed payments and estimated future royalties discounted to their fair value as of the transaction date of $ 7,085,000 and $ 15,765,000 respectively. The discounted fair values of the guaranteed payments and estimated future royalties were recorded as liabilities within the consolidated balance sheet on the transaction date as represented below. June 30, 2023 (In thousands) Assets: Product rights intangible asset $ 98,122 Liabilities: Accrued expenses 1,771 Accrued licensor payments 21,079 The Company concluded, based on the acquisition of a single asset due to substantially all of the value being concentrated in the Product Rights Agreement, lack of acquired employees and manufacturing, as well as absence of certain other inputs and acquired processes, that the transaction did not qualify as a business and therefore, recorded the acquisition of the License as an asset acquisition in accordance with ASC 805. Under ASC 805, the fair value cost of the net assets purchased is allocated, based on their relative fair value, to the acquired tangible assets and identified intangible assets and liabilities in accordance with U.S. GAAP. The gross carrying amount of the intangible asset is $ 98,122,000 , which is being amortized over approximately 10 years from the initial payment date (See Note 8). Acquisition costs associated with the acquisition of $ 272,000 were capitalized into the total purchase price of the transaction. Commercial Supply Agreement In connection with the Product Rights Agreement, the Company entered into a commercial supply agreement (the Supply Agreement) with EyePoint Parent pursuant to which, during the term of the Product Rights Agreement, EyePoint Parent will be responsible for manufacturing and exclusively supplying (subject to certain exceptions) to the Company agreed-upon quantities of YUTIQ necessary for Alimera to commercialize YUTIQ in the United States at certain cost plus amounts, subject to adjustments set forth in the Supply Agreement. EyePoint Parent’s manufacture and supply to Alimera of YUTIQ under the Supply Agreement will be exclusive (subject to certain exceptions set forth in the Supply Agreement) until Alimera has the right and ability to manufacture and supply YUTIQ for commercialization in the United States. The Company may elect to manufacture YUTIQ after an initial 18 -month term following the closing date upon the satisfaction of certain conditions. |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value [Abstract] | |
Fair Value | 18. FAIR VALUE The Company applies ASC 820, Fair Value Measurements , in determining the fair value of certain assets and liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various valuation approaches. The hierarchy of those valuation approaches is broken down into three levels based on the reliability of inputs as follows: Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment. Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include: quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, (e.g., interest rates and yield curves observable at commonly quoted intervals or current market) and contractual prices for the underlying financial instrument, as well as other relevant economic measures. Level 3 inputs are unobservable inputs for the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: June 30, 2023 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 93 $ — $ 93 Assets measured at fair value $ — $ 93 $ — $ 93 Liabilities: Common stock warrant liability (1) $ — $ 3,471 $ — $ 3,471 Liabilities measured at fair value $ — $ 3,471 $ — $ 3,471 December 31, 2022 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 183 $ — $ 183 Assets measured at fair value $ — $ 183 $ — $ 183 Liabilities: Common stock warrant liability (1) $ — $ — $ — $ — Liabilities measured at fair value $ — $ — $ — $ — (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 . |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 19. SUBSEQUENT EVENTS Pre- Funded Warrants On August 1, 2023, the Company amended the Certificate of Designation of Series B Convertible Preferred Stock. Prior to such amendment, the Certificate of Designation provided that the Series B Preferred would automatically convert at the then-applicable conversion price (Mandatory Conversion) in full into common stock following Stockholder Approval. As amended, the Certificate of Designation provides that the Company may issue pre-funded common stock warrants (Pre-Funded Warrants) to certain holders of Series B Preferred that elected to receive Pre- Funded Warrants prior to Stockholder Approval in lieu of a portion of common stock that would otherwise be issued in the Mandatory Conversion to such holders. The Pre-Funded Warrants have an exercise price of $0.01 per share. The Pre-Funded Warrants were offered to holders of Series B Preferred whose Mandatory Conversion of Series B Preferred would otherwise result in such holders, together with their affiliates and certain related parties, beneficially owning more than 9.99% of the outstanding common stock immediately following Mandatory Conversion the opportunity to purchase, if such holders so chose prior to Stockholder Approval, Pre-Funded Warrants, in lieu of shares of common stock that would otherwise result in such holder’s beneficial ownership exceeding 9.99% of the outstanding common stock. Stockholder Approvals On August 1, 2023, the Company’s stockholders provided Stockholder Approval, and the Company set August 15, 2023 as the date for the Mandatory Conversion. On August 1, 2023, the Company’s stockholders also approved the 2023 Equity Incentive Plan (the date of such approval, the Effective Date), which replaces the 2019 Plan. No new awards will be granted under the 2019 Plan. The 2023 Equity Incentive Plan has a share reserve equal to the sum of (a) 3,231,755 shares of common stock, (b) shares that are subject to awards granted under the 2019 Plan that are outstanding on or after the Effective Date and that are subsequently forfeited, cancelled, expire or lapse unexercised or unsettled or are reacquired by the Company, (c) the number of shares reserved under the 2019 Plan that are not issued or subject to outstanding awards under the 2019 Plan on the Effective Date, and (d) the increase in shares described in the next sentence. On the first anniversary of the Effective Date, the number of shares of common stock that may be issued under the 2023 Equity Incentive Plan will increase by a number of shares equal to 6% of the number of outstanding shares of common stock (assuming full conversion of the Series B Preferred into common stock). |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policy) | 6 Months Ended |
Jun. 30, 2023 | |
Summary of Significant Accounting Policies [Abstract] | |
Acquisition of Intangible Assets | Acquisition of Intangible Assets The Company accounts for the acquisition of pharmaceutical product licenses as an asset acquisition in accordance with FASB ASC 805 – Business Combinations (“ASC 805”). ASC 805 specifies that if substantially all of the fair value of the gross assets acquired in a transaction are concentrated in a single identifiable asset or group of similar identifiable assets, then the set is not a business and is recorded as an asset acquisition. Under this model, the Company assigns the cost of the transaction to the acquired tangible assets, to the identified intangible assets and liabilities and any above or below-market contracts. The purchase price, including the direct amounts paid for the net assets in the transaction and any acquisition costs incurred that relate directly to the acquisition, is assigned based on the relative fair values of the assets acquired and liabilities assumed. The fair value of any identified intangible assets is determined at the acquisition date based on inputs and other factors based on market participants. |
Adoption of New Accounting Standard and Accounting Standards Issued but Not Yet Effective | Adoption of New Accounting Standard In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (ASC 326): Measurement of Credit Losses on Financial Instruments . This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard became effective for the Company on January 1, 2023. The adoption of this ASU did not have a material impact on its financial statements. In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers. The amendments in this ASU require that an acquirer recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The amendments in this ASU are effective for fiscal years beginning after December 15, 2022, with early adoption permitted. The adoption of this ASU did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In March 2020, the FASB issued ASU 2020-04 , Reference Rate Reform (ASC 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting . This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard was available until December 31, 2022. In December 2022, the FASB issued ASU No. 2022-06 which extended the period of time preparers can utilize the reference rate reform relief guidance in Topic 848. The guidance ensures the relief in Topic 848 covers the period of time during which a significant number of modifications may take place and the ASU defers the sunset date of Topic 848 from December 31, 2022 to December 31, 2024. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Summary of Operating Leases Supplemental Balance Sheet Information | June 30, December 31, 2023 2022 (In thousands) NON-CURRENT ASSETS: Right of use assets, net $ 1,277 $ 1,395 Total lease assets $ 1,277 $ 1,395 CURRENT LIABILITIES: Accrued expenses $ 685 $ 768 NON-CURRENT LIABILITIES: Other non-current liabilities 2,029 2,267 Total lease liabilities $ 2,714 $ 3,035 |
Schedule of Future Minimum Operating Lease Payments | Years Ending December 31 (In thousands) 2023 (remaining) $ 354 2024 680 2025 474 2026 488 2027 503 Thereafter 1,052 Total 3,551 Less amount representing interest ( 837 ) Present value of minimum lease payments 2,714 Less current portion (as a portion of accrued expenses) ( 685 ) Non-current portion (as a portion of other non-current liabilities) $ 2,029 |
Summary of Finance Leases Supplemental Balance Sheet Information | June 30, December 31, 2023 2022 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 384 $ 366 Total lease assets $ 384 $ 366 CURRENT LIABILITIES: Finance lease obligations $ 203 $ 333 NON-CURRENT LIABILITIES: Other non-current liabilities 180 131 Total lease liabilities $ 383 $ 464 |
Schedule of Future Minimum Finance Lease Payments | Years Ending December 31 (In thousands) 2023 (remaining) $ 178 2024 177 2025 114 2026 15 Total 484 Less amount representing interest ( 101 ) Present value of minimum lease payments 383 Less current portion ( 203 ) Non-current portion $ 180 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory [Abstract] | |
Schedule of Inventory | June 30, December 31, 2023 2022 (In thousands) Component parts (1) $ 505 $ 152 Work-in-process (2) 73 560 Finished goods 477 893 Total Inventory $ 1,055 $ 1,605 (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 EEA regulatory authorities. |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
License Agreement [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Future Amortization | Years Ending December 31 (In thousands) 2023 (remaining) $ 978 2024 1,946 2025 1,940 2026 1,940 2027 1,191 Total $ 7,995 |
YUTIQ Intangible Asset [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Future Amortization | Years Ending December 31 (In thousands) 2023 (remaining) $ 4,942 2024 9,831 2025 9,804 2026 9,804 2027 9,804 Thereafter 52,755 Total $ 96,940 |
Loss Per Share (EPS) (Tables)
Loss Per Share (EPS) (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Loss Per Share (EPS) [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | June 30, 2023 2022 Series A convertible preferred stock — 601,504 Series B convertible preferred stock 45,272,874 — Common stock warrants 1,600,000 — Stock options 1,217,045 1,310,465 Total 48,089,919 1,911,969 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity Incentive Plans [Abstract] | |
Summary of Stock Option Transactions | The following table presents a summary of stock option activity for the three months ended June 30, 2023 and 2022: Three Months Ended June 30, 2023 2022 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,216,953 18.03 1,315,161 19.39 Grants 17,321 2.55 1,700 4.34 Forfeitures and expirations ( 17,229 ) 45.18 ( 6,396 ) 15.58 Exercises — — — — Options outstanding at period end 1,217,045 17.43 1,310,465 19.39 Options exercisable at period end 893,401 22.07 887,543 25.91 Weighted average per share fair value of options granted during the period $ 1.77 $ 2.94 |
Summary of Additional Stock Option Transactions | The following table presents a summary of stock option activity for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 2022 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,175,339 19.03 1,075,795 23.35 Grants 117,723 2.70 285,250 4.96 Forfeitures and expirations ( 76,017 ) 19.41 ( 50,580 ) 21.51 Exercises — — — — Options outstanding at period end 1,217,045 17.43 1,310,465 19.39 Options exercisable at period end 893,401 22.07 887,543 25.91 Weighted average per share fair value of options granted during the period $ 1.86 $ 3.32 The following table provides additional information related to outstanding stock options as of June 30, 2023: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,217,045 17.43 5.57 years 24 Exercisable 893,401 22.07 4.50 years 7 Outstanding, vested and expected to vest 1,182,115 17.81 5.48 years 22 The following table provides additional information related to outstanding stock options as of December 31, 2022: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,175,339 19.03 5.68 years — Exercisable 878,115 23.62 4.72 years — Outstanding, vested and expected to vest 1,139,482 19.46 5.58 years — |
Summary of Restricted Stock Transactions | The following table presents a summary of restricted stock and RSU activity for the three months ended June 30, 2023 and 2022: Three Months Ended June 30, 2023 2022 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 685,176 1.67 94,063 5.29 Grants — — — — Vested restricted stock and RSUs — — ( 7,500 ) 8.93 Forfeitures ( 3,000 ) 1.35 — — Restricted stock and RSUs outstanding at period end 682,176 1.67 86,563 4.98 The following table presents a summary of restricted stock and RSU activity for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 2022 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 73,594 4.98 46,250 5.65 Grants 632,050 1.39 57,500 4.96 Vested restricted stock and RSUs ( 20,468 ) 4.98 ( 9,687 ) 5.01 Forfeitures ( 3,000 ) 1.35 ( 7,500 ) 8.93 Restricted stock and RSUs outstanding at period end 682,176 1.67 86,563 4.98 |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Segment Information [Abstract] | |
Summary of Operations by Segment | Three Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 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 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 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 ) Three Months Ended June 30, 2022 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 8,943 $ 5,661 $ — $ — $ 14,604 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,060 ) ( 1,106 ) — — ( 2,166 ) GROSS PROFIT 7,883 4,555 — — 12,438 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,281 807 1,799 45 3,932 GENERAL AND ADMINISTRATIVE EXPENSES 195 468 2,112 170 2,945 SALES AND MARKETING EXPENSES 4,568 2,112 133 52 6,865 DEPRECIATION AND AMORTIZATION — — — 670 670 OPERATING EXPENSES 6,044 3,387 4,044 937 14,412 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,839 1,168 ( 4,044 ) ( 937 ) ( 1,974 ) OTHER INCOME AND EXPENSES, NET — — — ( 1,124 ) ( 1,124 ) NET LOSS BEFORE TAXES $ ( 3,098 ) The following tables present a summary of the Company’s reporting segments for the six months ended June 30, 2023 and 2022: Six Months Ended June 30, 2023 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 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 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 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 ) Six Months Ended June 30, 2022 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 15,863 $ 10,639 $ — $ — $ 26,502 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,875 ) ( 1,971 ) — — ( 3,846 ) GROSS PROFIT 13,988 8,668 — — 22,656 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 2,451 1,723 3,259 82 7,515 GENERAL AND ADMINISTRATIVE EXPENSES 511 892 4,393 389 6,185 SALES AND MARKETING EXPENSES 9,242 4,116 250 110 13,718 DEPRECIATION AND AMORTIZATION — — — 1,359 1,359 OPERATING EXPENSES 12,204 6,731 7,902 1,940 28,777 SEGMENT INCOME (LOSS) FROM OPERATIONS 1,784 1,937 ( 7,902 ) ( 1,940 ) ( 6,121 ) OTHER INCOME AND EXPENSES, NET — — — ( 2,932 ) ( 2,932 ) NET INCOME BEFORE TAXES $ ( 9,053 ) |
Other Agreements with Eyepoin_2
Other Agreements with Eyepoint Parent and Eyepoint (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Other Agreements with Eyepoint Parent and Eyepoint [Abstract] | |
Schedule of Other Agreements Included in Consolidated Balance Sheet | June 30, 2023 (In thousands) Assets: Product rights intangible asset $ 98,122 Liabilities: Accrued expenses 1,771 Accrued licensor payments 21,079 |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value [Abstract] | |
Fair Value of Assets and Liabilities | June 30, 2023 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 93 $ — $ 93 Assets measured at fair value $ — $ 93 $ — $ 93 Liabilities: Common stock warrant liability (1) $ — $ 3,471 $ — $ 3,471 Liabilities measured at fair value $ — $ 3,471 $ — $ 3,471 December 31, 2022 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 183 $ — $ 183 Assets measured at fair value $ — $ 183 $ — $ 183 Liabilities: Common stock warrant liability (1) $ — $ — $ — $ — Liabilities measured at fair value $ — $ — $ — $ — (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 |
Nature of Operations (Narrative
Nature of Operations (Narrative) (Details) - ILUVIEN [Member] | Jun. 30, 2023 country |
Nature Of Operations [Line Items] | |
Number of countries in which product has received marketing authorization and reimbursement for the treatment of diabetic macular edema | 24 |
Number of countries in which product is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies | 17 |
Number of countries authorized for marketing | 17 |
Number of countries with reimbursement approval | 10 |
Revenue Recognition (Narrative)
Revenue Recognition (Narrative) (Details) | 6 Months Ended |
Jun. 30, 2023 | |
Period before expiration date returns are accepted | 3 months |
Period after expiration date returns are accepted | 1 year |
Minimum [Member] | |
Customer payment obligation, period | 30 years |
Maximum [Member] | |
Customer payment obligation, period | 120 years |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Lessee, Lease, Description [Line Items] | ||||
Operating lease cost | $ 256,000 | $ 134,000 | $ 405,000 | $ 272,000 |
Cash paid for leases | 176,000 | 64,000 | 351,000 | 132,000 |
Property and equipment acquired under operating leases | $ 0 | 0 | $ 0 | 0 |
Weighted average remaining lease term | 6 years | 6 years | ||
Weighted average discount rate, leases | 9.50% | 9.50% | ||
Depreciation expense property and equipment under finance leases | $ 71,000 | 65,000 | $ 123,000 | 155,000 |
Finance lease interest expense | 11,000 | 10,000 | 22,000 | 21,000 |
Cash paid for finance leases | 132,000 | 167,000 | 251,000 | 175,000 |
Property and equipment acquired under finance leases | $ 80,000 | $ 0 | $ 170,000 | $ 0 |
Finance lease, weighted average remaining term | 9 months 18 days | 9 months 18 days | ||
Finance lease, weighted average discount rate | 9.90% | 9.90% | ||
Minimum [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease renewal term | 1 year | 1 year | ||
Maximum [Member] | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease renewal term | 8 years | 8 years |
Leases (Summary of Operating Le
Leases (Summary of Operating Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
NON-CURRENT ASSETS: | ||
Total lease assets | $ 1,277 | $ 1,395 |
CURRENT LIABILITIES: | ||
Accrued expenses | 685 | $ 768 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | |
NON-CURRENT LIABILITIES: | ||
Other non-current liabilities | 2,029 | $ 2,267 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | |
Total lease liabilities | $ 2,714 | $ 3,035 |
Leases (Schedule of Future Mini
Leases (Schedule of Future Minimum Operating Lease Payments) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 (remaining) | $ 354 | |
2024 | 680 | |
2025 | 474 | |
2026 | 488 | |
2027 | 503 | |
Thereafter | 1,052 | |
Total | 3,551 | |
Less amount representing interest | (837) | |
Total lease liabilities | 2,714 | $ 3,035 |
Less current portion (as a portion of accrued expenses) | (685) | $ (768) |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | |
Non-current portion (as a portion of other non-current liabilities) | $ 2,029 | $ 2,267 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent |
Leases (Summary of Finance Leas
Leases (Summary of Finance Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
NON-CURRENT ASSETS: | ||
Total lease assets | $ 384 | $ 366 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property, Plant and Equipment, Net | |
CURRENT LIABILITIES: | ||
Finance lease obligations | $ 203 | 333 |
NON-CURRENT LIABILITIES: | ||
Other non-current liabilities | $ 180 | 131 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | |
Total lease liabilities | $ 383 | $ 464 |
Leases (Schedule of Future Mi_2
Leases (Schedule of Future Minimum Finance Lease Payments) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Total lease liabilities | $ 383 | $ 464 |
Less current portion | (203) | (333) |
Non-current portion | $ 180 | $ 131 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | |
Property, Plant and Equipment [Member] | ||
2023 (remaining) | $ 178 | |
2024 | 177 | |
2025 | 114 | |
2026 | 15 | |
Total | 484 | |
Less amount representing interest | (101) | |
Total lease liabilities | 383 | |
Less current portion | (203) | |
Non-current portion | $ 180 |
Going Concern (Narrative) (Deta
Going Concern (Narrative) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||||
Accumulated deficit | $ 412,779 | $ 415,388 | ||
Cash and cash equivalents | $ 18,807 | $ 5,304 | $ 7,890 | $ 16,544 |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory | ||
Component parts | $ 505 | $ 152 |
Work-in-process | 73 | 560 |
Finished goods | 477 | 893 |
Total inventory | $ 1,055 | $ 1,605 |
Intangible Assets (Narrative) (
Intangible Assets (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
May 17, 2023 | Oct. 31, 2014 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2024 | Dec. 31, 2022 | |
Finite-Lived Intangible Assets [Line Items] | ||||||||
Gross intangible assets | $ 25,000,000 | $ 25,000,000 | ||||||
Useful life (in years) | 13 years | |||||||
Amortization of intangible assets | 484,000 | $ 484,000 | $ 962,000 | $ 962,000 | ||||
Net intangible assets | 104,935,000 | 104,935,000 | $ 8,957,000 | |||||
License Agreement [Member] | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Net intangible assets | 7,995,000 | 7,995,000 | $ 8,957,000 | |||||
YUTIQ Intangible Asset [Member] | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Gross intangible assets | 98,122,000 | $ 98,122,000 | ||||||
Useful life (in years) | 10 years | |||||||
Amortization of intangible assets | 1,182,000 | $ 1,182,000 | ||||||
Net intangible assets | $ 96,940,000 | $ 96,940,000 | ||||||
Eyepoint License Agreement [Member] | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Milestone payment after the first product approved by the FDA | $ 25,000,000 | |||||||
Eyepoint License Agreement [Member] | Product Rights [Member] | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Gross intangible assets | $ 98,122,000 | |||||||
Upfront payment | $ 75,000,000 | |||||||
Eyepoint License Agreement [Member] | Forecast [Member] | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Milestone payment after the first product approved by the FDA | $ 7,500,000 | |||||||
Eyepoint License Agreement [Member] | Forecast [Member] | Product Rights [Member] | ||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||
Milestone payment after the first product approved by the FDA | $ 7,500,000 |
Intangible Assets (Future Amort
Intangible Assets (Future Amortization) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Total | $ 104,935 | $ 8,957 |
License Agreement [Member] | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2023 (remaining) | 978 | |
2024 | 1,946 | |
2025 | 1,940 | |
2026 | 1,940 | |
2027 | 1,191 | |
Total | 7,995 | $ 8,957 |
YUTIQ Intangible Asset [Member] | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2023 (remaining) | 4,942 | |
2024 | 9,831 | |
2025 | 9,804 | |
2026 | 9,804 | |
2027 | 9,804 | |
Thereafter | 52,755 | |
Total | $ 96,940 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2019 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Aug. 01, 2017 | |
Collaborative Arrangement, Co-promotion [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Collaborative arrangement, royalty payable on net revenue, percentage | 5.20% | 5.20% | 5.20% | 5.20% | ||
Collaborative arrangement, increase in royalty payable on net revenue (as a percentage) | 6% | 6% | 6% | 6% | ||
Collaborative arrangement, royalty payable on net revenue over threshold, percentage | 2% | |||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000,000 | |||||
Royalty expense | $ 463,000 | $ 758,000 | 857,000 | $ 1,375,000 | ||
Accrued royalty expense | 857,000 | 857,000 | ||||
Eyepoint License Agreement [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | |||||
Eyepoint License Agreement [Member] | Maximum [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recoverable amount to offset future royalty payments | 6,762,000 | 6,762,000 | $ 15,000,000 | |||
Ocumension [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Payment from related party | 10,000,000 | |||||
Revenue from related party | $ 11,048,000 | |||||
License agreement, shares purchased | 1,000,000 | |||||
License agreement, share purchase duration | 4 years | |||||
Deferred revenue related party | $ 300,000 | $ 300,000 | ||||
Ocumension [Member] | Milestone One [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Payment from related party | $ 89,000,000 |
Loan Agreements (SLR Investment
Loan Agreements (SLR Investment Corp.) (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
May 17, 2023 | Mar. 24, 2023 | Jun. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2019 | Jan. 05, 2018 | |
Debt Instrument [Line Items] | ||||||
Loss on extinguishment of debt | $ 1,079,000 | $ 1,079,000 | $ 1,079,000 | |||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2018 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Line of credit facility, maximum borrowing capacity | $ 40,000,000 | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Increase in borrowing capacity | $ 2,500,000 | |||||
Line of credit facility, maximum borrowing capacity | $ 47,500,000 | $ 45,000,000 | ||||
Debt instrument, interest rate, stated percentage | 5.15% | 5.15% | ||||
Interest rate effective percentage | 9.75% | 9.75% | ||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Amendment 3 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loan amendment, minimum revenue amount trailing period | 6 months | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Amendment 4 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loan amendment, minimum revenue amount trailing period | 6 months | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Amendment 5 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Option to extend term | 12 months | |||||
Loan amendment, minimum revenue amount trailing period | 6 months | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Amendment 6 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Loan amendment, minimum revenue amount trailing period | 6 months | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 4.60% | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | SLR Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, interest rate, stated percentage | 7.65% | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | SLR Loan [Member] | London Interbank Offered Rate (LIBOR) [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 1.78% | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 15,000,000 | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Term Loan [Member] | Amendment 5 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 15,000,000 | |||||
Debt instrument, interest rate, stated percentage | 5.15% | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Term Loan [Member] | Amendment 6 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 20,000,000 | |||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Term Loan [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | Amendment 5 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 4.60% | |||||
2018 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, exit fee agreement, term | 10 years | |||||
Debt instrument, exit fee | $ 2,000,000 | |||||
2018 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Achievement of Milestone [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, exit fee | 1,000,000 | |||||
2018 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Milestone 1 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Milestone revenue requirement | $ 80,000,000 | |||||
Milestone period requirement | 12 months | |||||
2018 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Milestone 2 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Milestone revenue requirement | $ 100,000,000 | |||||
2019 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, exit fee agreement, term | 10 years | |||||
Debt instrument, exit fee | $ 2,000,000 | |||||
2019 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Milestone 2 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, exit fee | $ 675,000 | |||||
2019 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Amendment 5 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Increase in borrowing capacity | $ 2,500,000 | |||||
Line of credit facility, maximum borrowing capacity | $ 47,500,000 | |||||
2023 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, exit fee agreement, term | 10 years | |||||
Exit fee, percentage of original principal amount funded | 1.50% | |||||
Milestone revenue requirement | $ 82,500,000 |
Loan Agreements (Modification o
Loan Agreements (Modification of Debt) (Narrative) (Details) - Loan Agreement 2019 [Member] - SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Jun. 30, 2023 USD ($) |
Amendment 4 [Member] | |
Debt Instrument [Line Items] | |
Deferred financing costs | $ 113,000 |
Amendment 5 [Member] | |
Debt Instrument [Line Items] | |
Deferred financing costs | $ 2,625,000 |
Loss Per Share (EPS) (Schedule
Loss Per Share (EPS) (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 48,089,919 | 1,911,969 |
Series A Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 601,504 | |
Series B Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 45,272,874 | |
Common Stock Warrants [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,600,000 | |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,217,045 | 1,310,465 |
Preferred Stock (Narrative) (De
Preferred Stock (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
May 17, 2023 | Mar. 24, 2023 | Oct. 31, 2012 | Mar. 31, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2019 | |
Conversion of Stock [Line Items] | ||||||||
Preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 | ||||||
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 | ||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 300,000 | |||||||
Stock issuance costs incurred | $ 560,000 | $ 509,000 | ||||||
Proceeds from issuance of preferred stock | 78,339,000 | |||||||
Proceeds from issuance of common stock | $ 2,404,000 | $ 40,000 | ||||||
Shares repurchased | $ 1,252,000 | |||||||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 | ||||||
Securities Purchase Agreement [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Proceeds from issuance of preferred stock | 12,000,000 | |||||||
Tranche One [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Proceeds from issuance of preferred stock | $ 12,000,000 | |||||||
Series A Preferred Stock [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 1,000,000 | |||||||
Preferred stock, shares outstanding (in shares) | 0 | 600,000 | ||||||
Preferred stock, shares issued (in shares) | 0 | 600,000 | ||||||
Proceeds from issuance of preferred stock | $ 40,000,000 | |||||||
Shares repurchased (in shares) | 600,000 | |||||||
Shares repurchased | $ 938,000 | |||||||
Preferred stock, liquidation preference | $ 24,000,000 | |||||||
Preferred stock, shares authorized (in shares) | 0 | 1,300,000 | ||||||
Series B Preferred Stock [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Preferred stock, shares outstanding (in shares) | 78,617 | 0 | ||||||
Preferred stock, shares issued (in shares) | 78,617 | 0 | ||||||
Preferred stock dividend rate percentage | 6% | |||||||
Preferred stock dividends in arrears | $ 683,000 | |||||||
Preferred stock dividends in arrears, per share | $ 5 | |||||||
Preferred stock, liquidation preference | $ 0 | |||||||
Preferred stock, shares authorized (in shares) | 78,617 | 0 | ||||||
Series B Preferred Stock [Member] | Securities Purchase Agreement [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Preferred stock, par value (usd per share) | $ 0.01 | |||||||
Series B Preferred Stock [Member] | Tranche One [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 12,000 | |||||||
Share Price | $ 1,000 | |||||||
Preferred stock conversion price (usd per share) | $ 2.10 | |||||||
Class of Warrant or Right, Expiration Period | 7 years | |||||||
Series B Preferred Stock [Member] | Tranche Two [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Preferred stock conversion price (usd per share) | $ 1.70 | |||||||
Series B Preferred Stock [Member] | Purchase Agreement Amendment [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 66,617 | |||||||
Common Stock [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Shares repurchased (in shares) | 200,919 | |||||||
Common Stock [Member] | Tranche Two [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 1,401,901 | |||||||
Proceeds from issuance of common stock | $ 69,000,000 | |||||||
Common Stock [Member] | Purchase Agreement Amendment [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 1,600,000 | |||||||
Minimum [Member] | Common Stock [Member] | Before Conversion [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Ownership interest of holders after conversion of preferred stock (percent) | 19.99% | |||||||
Minimum [Member] | Common Stock [Member] | After Conversion [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Ownership interest of holders after conversion of preferred stock (percent) | 9.99% | |||||||
Maximum [Member] | Series B Preferred Stock [Member] | Securities Purchase Agreement [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 27,000 | |||||||
Maximum [Member] | Common Stock [Member] | Securities Purchase Agreement [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 5,714,286 | |||||||
Shares issued in conversion of preferred stock (in shares) | 1,401,901 | |||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | ||||||||
Conversion of Stock [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 47,500,000 | $ 45,000,000 |
Equity Incentive Plans (Narrati
Equity Incentive Plans (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 442 | $ 581 | |||
Weighted average contractual term | 4 years 6 months | 4 years 8 months 19 days | |||
2019 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for grant (in shares) | 52,283 | 52,283 | |||
Stock Options [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 148 | $ 218 | $ 315 | 476 | |
Share-based compensation not yet recognized | $ 895 | $ 895 | |||
Weighted average contractual term | 2 years 3 months 18 days | ||||
New Awards [Member] | Equity Incentive Plan 2010 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for grant (in shares) | 0 | 0 | |||
Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 62 | 43 | $ 109 | 89 | |
Weighted average contractual term | 3 years 7 months 13 days | ||||
Unrecognized share based compensation expense | 1,120 | $ 1,120 | |||
Employee Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 7 | $ 7 | $ 18 | $ 15 |
Equity Incentive Plans (Summary
Equity Incentive Plans (Summary of Stock Option Transactions) (Details) - $ / shares | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Options | |||||
Options outstanding at beginning of period | 1,216,953 | 1,315,161 | 1,175,339 | 1,075,795 | |
Grants | 17,321 | 1,700 | 117,723 | 285,250 | |
Forfeitures and expirations | (17,229) | (6,396) | (76,017) | (50,580) | |
Exercises | |||||
Options outstanding at period end | 1,217,045 | 1,310,465 | 1,217,045 | 1,310,465 | |
Options exercisable at period end | 893,401 | 887,543 | 893,401 | 887,543 | 878,115 |
Weighted average per share fair value of options granted during the period | $ 1.77 | $ 2.94 | $ 1.86 | $ 3.32 | |
Weighted Average Exercise Price ($) | |||||
Options outstanding at beginning of period | 18.03 | 19.39 | 19.03 | 23.35 | |
Grants | 2.55 | 4.34 | 2.70 | 4.96 | |
Forfeitures and expirations | 45.18 | 15.58 | 19.41 | 21.51 | |
Exercises | |||||
Options outstanding at period end | 17.43 | 19.39 | 17.43 | 19.39 | |
Options exercisable at period end | $ 22.07 | $ 25.91 | $ 22.07 | $ 25.91 | $ 23.62 |
Equity Incentive Plans (Summa_2
Equity Incentive Plans (Summary of Additional Stock Option Transactions) (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2023 | Dec. 31, 2022 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Dec. 31, 2021 | |
Outstanding Stock Options | ||||||
Outstanding, shares (in shares) | 1,217,045 | 1,175,339 | 1,216,953 | 1,310,465 | 1,315,161 | 1,075,795 |
Outstanding, weighted average exercise price (usd per share) | $ 17.43 | $ 19.03 | $ 18.03 | $ 19.39 | $ 19.39 | $ 23.35 |
Outstanding, weighted average remaining contractual term | 5 years 6 months 25 days | 5 years 8 months 4 days | ||||
Outstanding, aggregate intrinsic value | $ 24 | |||||
Exercisable Stock Options | ||||||
Exercisable, shares (in shares) | 893,401 | 878,115 | 887,543 | |||
Exercisable, weighted average exercise price (usd per share) | $ 22.07 | $ 23.62 | $ 25.91 | |||
Exercisable, weighted average remaining contractual term | 4 years 6 months | 4 years 8 months 19 days | ||||
Exercisable, aggregate intrinsic value | $ 7 | |||||
Exercisable and expected to vest | ||||||
Outstanding, vested and expected to vest, shares (in shares) | 1,182,115 | 1,139,482 | ||||
Outstanding, vested and expected to vest, weighted average exercise price (usd per share) | $ 17.81 | $ 19.46 | ||||
Outstanding, vested and expected to vest, weighted average remaining contractual term | 5 years 5 months 23 days | 5 years 6 months 29 days | ||||
Outstanding, vested and expected to vest, aggregate intrinsic value | $ 22 |
Equity Incentive Plans (Summa_3
Equity Incentive Plans (Summary of Restricted Stock Transactions) (Details) - Restricted Stock and Restricted Stock Units [Member] - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Restricted Stock & RSUs | ||||
Beginning of period (in shares) | 685,176 | 94,063 | 73,594 | 46,250 |
Grants (in shares) | 632,050 | 57,500 | ||
Vested restricted stock and RSUs (in shares) | (7,500) | (20,468) | (9,687) | |
Forfeitures (in shares) | (3,000) | (3,000) | (7,500) | |
End of period (in shares) | 682,176 | 86,563 | 682,176 | 86,563 |
Weighted Average Grant Date Fair Value ($) | ||||
Beginning of period (usd per share) | $ 1.67 | $ 5.29 | $ 4.98 | $ 5.65 |
Grants (usd per share) | 1.39 | 4.96 | ||
Vested restricted stock and RSUs (usd per share) | 8.93 | 4.98 | 5.01 | |
Forfeitures (usd per share) | 1.35 | 1.35 | 8.93 | |
End of period (usd per share) | $ 1.67 | $ 4.98 | $ 1.67 | $ 4.98 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Operating Loss Carryforwards [Line Items] | |
Deferred tax asset, research and development costs | $ 969 |
Federal [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry-forwards | 147,200 |
State [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry-forwards | $ 107,700 |
Segment Information (Narrative)
Segment Information (Narrative) (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 customer | Jun. 30, 2022 customer | Jun. 30, 2023 segment customer | Jun. 30, 2022 customer | Dec. 31, 2022 segment | |
Segment Reporting Information [Line Items] | |||||
Number of operating segments | 3 | ||||
Customer Concentration Risk [Member] | Revenues [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Number of customers | customer | 2 | 2 | 2 | 2 | |
Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Number of customers | 2 | 2 | |||
Large Pharmaceutical Distributors [Member] | Customer Concentration Risk [Member] | Revenues [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Concentration risk percentage | 68% | 61% | 63% | 60% | |
Large Pharmaceutical Distributors [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||||
Segment Reporting Information [Line Items] | |||||
Concentration risk percentage | 71% | 71% |
Segment Information (Summary of
Segment Information (Summary of Operations by Segment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Segment Reporting Information [Line Items] | ||||
REVENUE, NET | $ 17,538 | $ 14,604 | $ 31,084 | $ 26,502 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (2,425) | (2,166) | (4,453) | (3,846) |
GROSS PROFIT | 15,113 | 12,438 | 26,631 | 22,656 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,648 | 3,932 | 7,812 | 7,515 |
GENERAL AND ADMINISTRATIVE EXPENSES | 4,373 | 2,945 | 8,544 | 6,185 |
SALES AND MARKETING EXPENSES | 6,434 | 6,865 | 12,238 | 13,718 |
DEPRECIATION AND AMORTIZATION | 1,866 | 670 | 2,547 | 1,359 |
OPERATING EXPENSES | 16,321 | 14,412 | 31,141 | 28,777 |
LOSS FROM OPERATIONS | (1,208) | (1,974) | (4,510) | (6,121) |
OTHER INCOME AND EXPENSES, NET | (8,796) | (1,124) | (10,462) | (2,932) |
NET LOSS BEFORE TAXES | (10,004) | (3,098) | (14,972) | (9,053) |
U.S. [Member] | ||||
Segment Reporting Information [Line Items] | ||||
REVENUE, NET | 11,876 | 8,943 | 19,456 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,290) | (1,060) | (2,195) | (1,875) |
GROSS PROFIT | 10,586 | 7,883 | 17,261 | 13,988 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,748 | 1,281 | 2,910 | 2,451 |
GENERAL AND ADMINISTRATIVE EXPENSES | 1,101 | 195 | 2,205 | 511 |
SALES AND MARKETING EXPENSES | 4,781 | 4,568 | 9,056 | 9,242 |
OPERATING EXPENSES | 7,630 | 6,044 | 14,171 | 12,204 |
LOSS FROM OPERATIONS | 2,956 | 1,839 | 3,090 | 1,784 |
International [Member] | ||||
Segment Reporting Information [Line Items] | ||||
REVENUE, NET | 5,662 | 5,661 | 11,628 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,135) | (1,106) | (2,258) | (1,971) |
GROSS PROFIT | 4,527 | 4,555 | 9,370 | 8,668 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 842 | 807 | 1,589 | 1,723 |
GENERAL AND ADMINISTRATIVE EXPENSES | 510 | 468 | 1,227 | 892 |
SALES AND MARKETING EXPENSES | 1,379 | 2,112 | 2,794 | 4,116 |
OPERATING EXPENSES | 2,731 | 3,387 | 5,610 | 6,731 |
LOSS FROM OPERATIONS | 1,796 | 1,168 | 3,760 | 1,937 |
Operating Cost [Member] | ||||
Segment Reporting Information [Line Items] | ||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,033 | 1,799 | 3,266 | 3,259 |
GENERAL AND ADMINISTRATIVE EXPENSES | 2,619 | 2,112 | 4,814 | 4,393 |
SALES AND MARKETING EXPENSES | 225 | 133 | 291 | 250 |
OPERATING EXPENSES | 3,877 | 4,044 | 8,371 | 7,902 |
LOSS FROM OPERATIONS | (3,877) | (4,044) | (8,371) | (7,902) |
Other Segments [Member] | ||||
Segment Reporting Information [Line Items] | ||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 25 | 45 | 47 | 82 |
GENERAL AND ADMINISTRATIVE EXPENSES | 143 | 170 | 298 | 389 |
SALES AND MARKETING EXPENSES | 49 | 52 | 97 | 110 |
DEPRECIATION AND AMORTIZATION | 1,866 | 670 | 2,547 | 1,359 |
OPERATING EXPENSES | 2,083 | 937 | 2,989 | 1,940 |
LOSS FROM OPERATIONS | (2,083) | (937) | (2,989) | (1,940) |
OTHER INCOME AND EXPENSES, NET | $ (8,796) | $ (1,124) | $ (10,462) | (2,932) |
Product [Member] | ||||
Segment Reporting Information [Line Items] | ||||
REVENUE, NET | 26,502 | |||
Product [Member] | U.S. [Member] | ||||
Segment Reporting Information [Line Items] | ||||
REVENUE, NET | 15,863 | |||
Product [Member] | International [Member] | ||||
Segment Reporting Information [Line Items] | ||||
REVENUE, NET | $ 10,639 |
Other Agreements with Ocumens_2
Other Agreements with Ocumension (Narrative) (Details) $ / shares in Units, $ in Thousands | Apr. 14, 2021 USD ($) $ / shares shares | Apr. 14, 2021 $ / shares shares | Apr. 09, 2021 | Oct. 31, 2012 shares |
Related Party Transaction [Line Items] | ||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 300,000 | |||
Ocumension [Member] | ||||
Related Party Transaction [Line Items] | ||||
Partnership agreement, shares sold | 1,144,945 | |||
Partnership agreement, price per share | $ / shares | $ 8.734044 | |||
Partnership agreement, percentage of shares outstanding before closing | 19.90% | |||
Partnership agreement, consideration received | $ | $ 10,000 | |||
Partnership agreement, warrant or rights period | 4 years | |||
Shares called by warrants | 1,000,000 | 1,000,000 | ||
Exchange rate | 0.12853 | |||
Class of warrant or right, exercise price of warrants or rights (per share) | (per share) | $ 3.07 | $ 23.88 |
Other Agreements with Eyepoin_3
Other Agreements with Eyepoint Parent and Eyepoint (Narrative) (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |||
May 17, 2023 | Oct. 31, 2014 | Jun. 30, 2023 | Dec. 31, 2025 | Dec. 31, 2024 | |
Related Party Transaction [Line Items] | |||||
Gross intangible assets | $ 25,000,000 | ||||
Eyepoint License Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Additional guaranty payments | $ 25,000,000 | ||||
Forecast [Member] | Eyepoint License Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Additional guaranty payments | $ 7,500,000 | ||||
Product Rights [Member] | Eyepoint License Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Upfront payment | $ 75,000,000 | ||||
Intangible asset acquired | 98,122,000 | 98,122,000 | |||
Guaranteed payments | 7,085,000 | ||||
Estimated future royalties discounted to fair value | 15,765,000 | ||||
Gross intangible assets | $ 98,122,000 | ||||
Amortization period | 10 years | ||||
Acquisition costs | $ 272,000 | ||||
Product Rights [Member] | Forecast [Member] | Eyepoint License Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Additional guaranty payments | $ 7,500,000 | ||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 70,000,000,000,000 | ||||
YUTIQ Intangible Asset [Member] | |||||
Related Party Transaction [Line Items] | |||||
Gross intangible assets | $ 98,122,000 | ||||
YUTIQ Intangible Asset [Member] | Eyepoint License Agreement [Member] | |||||
Related Party Transaction [Line Items] | |||||
Manufacture election, following satisfaction of certain condition, initial term | 18 months |
Other Agreements with Eyepoin_4
Other Agreements with Eyepoint Parent and Eyepoint (Schedule of Other Agreements Included in Consolidated Balance Sheet) (Details) - USD ($) $ in Thousands | 6 Months Ended | |
May 17, 2023 | Jun. 30, 2023 | |
Related Party Transaction [Line Items] | ||
Accrued licensor payments | $ 21,079 | |
Product Rights [Member] | Eyepoint License Agreement [Member] | ||
Related Party Transaction [Line Items] | ||
Product rights intangible asset | $ 98,122 | 98,122 |
Accrued expenses | 1,771 | |
Accrued licensor payments | $ 21,079 |
Fair Value (Fair Value of Asset
Fair Value (Fair Value of Assets and Liabilities) (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant asset | $ 93 | $ 183 |
Assets measured at fair value | 93 | 183 |
Common stock warrant liability | 3,471 | |
Liabilities measured at fair value | 3,471 | |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant asset | 93 | 183 |
Assets measured at fair value | 93 | $ 183 |
Common stock warrant liability | 3,471 | |
Liabilities measured at fair value | $ 3,471 |
Subsequent Events (Narrative) (
Subsequent Events (Narrative) (Details) | Jun. 30, 2023 shares |
2019 Plan [Member] | |
Subsequent Event [Line Items] | |
Shares available for grant (in shares) | 52,283 |