Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2024 | May 09, 2024 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Current Fiscal Year End Date | --12-31 | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Year Focus | 2024 | |
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, $0.01 par value per share | |
Trading Symbol | ALIM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Smaller Reporting Company | true | |
Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity common stock, shares outstanding (in shares) | 52,388,513 | |
Entity Central Index Key | 0001267602 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 14,314 | $ 12,058 |
Restricted cash | 32 | 32 |
Accounts receivable, net | 34,224 | 34,545 |
Prepaid expenses and other current assets | 3,693 | 3,909 |
Inventory | 2,206 | 1,879 |
Total current assets | 54,469 | 52,423 |
Property and equipment, net | 2,377 | 2,466 |
Right-of-use assets, net | 1,060 | 1,124 |
Intangible assets, net | 94,471 | 97,355 |
Deferred tax asset | 102 | 104 |
Warrant asset | 6 | 52 |
Total assets | 152,485 | 153,524 |
Current liabilities: | ||
Accounts payable | 10,308 | 8,252 |
Accrued expenses | 4,779 | 6,192 |
Accrued licensor payment | 5,482 | 7,275 |
Finance lease obligations | 220 | 194 |
Total current liabilities | 20,789 | 21,913 |
Long-term liabilities: | ||
Notes payable, net of discount | 69,436 | 64,489 |
Accrued licensor payments | 15,616 | 15,136 |
Other non-current liabilities | 5,991 | 5,816 |
Total liabilities | 111,832 | 107,354 |
Commitments and contingencies (notes 8 and 15) | ||
Stockholders' equity: | ||
Preferred stock, $.01 par value — 10,000,000 shares authorized at March 31, 2024 and December 31, 2023, none issued | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 52,374,687 shares issued and outstanding at March 31, 2024 and 52,354,450 shares issued and outstanding at December 31, 2023 | 524 | 524 |
Common stock warrants | 4,396 | 4,396 |
Additional paid-in capital | 463,328 | 462,446 |
Accumulated deficit | (424,741) | (418,490) |
Accumulated other comprehensive loss | (2,854) | (2,706) |
Total stockholders’ equity | 40,653 | 46,170 |
Total liabilities and stockholders’ equity | $ 152,485 | $ 153,524 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Condensed Consolidated Balance Sheets [Abstract] | ||
Preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
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) | 52,374,687 | 52,354,450 |
Common stock, shares outstanding (in shares) | 52,374,687 | 52,354,450 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Operations [Abstract] | ||
Net revenue | $ 23,011 | $ 13,546 |
Cost of goods sold, excluding depreciation and amortization | (3,353) | (2,028) |
Gross profit | 19,658 | 11,518 |
Operating expenses: | ||
Research, development and medical affairs expenses | 4,361 | 4,164 |
General and administrative expenses | 5,432 | 4,171 |
Sales and marketing expenses | 9,082 | 5,804 |
Depreciation and amortization | 3,085 | 681 |
Total operating expenses | 21,960 | 14,820 |
Loss from operations | (2,302) | (3,302) |
Interest expense and other, net | (3,739) | (1,667) |
Unrealized foreign currency loss, net | (196) | (13) |
Change in fair value of warrant asset | (46) | 14 |
Net loss before income taxes | (6,283) | (4,968) |
Income tax benefit | 32 | |
Net loss | (6,251) | (4,968) |
Preferred stock dividends | (14) | |
Net loss applicable to common stockholders | $ (6,251) | $ (4,982) |
Net loss per share — basic | $ (0.12) | $ (0.71) |
Net loss per share — diluted | $ (0.12) | $ (0.71) |
Weighted average shares outstanding — Basic | 54,356,828 | 7,032,231 |
Weighted average shares outstanding — Diluted | 54,356,828 | 7,032,231 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Condensed Consolidated Statements of Comprehensive (Loss) Income [Abstract] | ||
Net loss | $ (6,251) | $ (4,968) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustments | (148) | 172 |
Total other comprehensive (loss) income | (148) | 172 |
Comprehensive loss: | $ (6,399) | $ (4,796) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (6,251) | $ (4,968) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 3,085 | 681 |
Provision for credit losses | 176 | 871 |
Unrealized foreign currency transaction gain, net | 196 | 13 |
Amortization of debt discount and deferred financing costs | 246 | 282 |
Stock-based compensation expense | 845 | 226 |
Change in fair value of warrant asset | 46 | (14) |
Changes in assets and liabilities: | ||
Accounts receivable | (89) | 430 |
Prepaid expenses and other current assets | 217 | 70 |
Inventory | (333) | 397 |
Accounts payable | 2,108 | (434) |
Accrued expenses and other current liabilities | (1,292) | 215 |
Other long-term liabilities | 480 | 22 |
Net cash used in operating activities | (566) | (2,209) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (21) | (9) |
Net cash used in investing activities | (21) | (9) |
Cash flows from financing activities: | ||
Repurchase of Series A Preferred Stock | (938) | |
Proceeds from issuance of Series B Convertible Preferred Stock | 12,000 | |
Series B Convertible Preferred Stock issuance costs | (498) | |
Proceeds from exercise of stock options | 37 | |
Repurchase of common stock | (314) | |
Issuance of debt | 5,000 | 2,500 |
Payment of debt costs | (62) | (2,625) |
Payment of accrued licensor obligations | (1,875) | |
Payment of finance lease obligations | (133) | (127) |
Net cash provided by financing activities | 2,967 | 9,998 |
Effect of exchange rates on cash and cash equivalents and restricted cash | (124) | 33 |
Net change in cash and cash equivalents and restricted cash | 2,256 | 7,813 |
Cash and cash equivalents and restricted cash — beginning of period | 12,090 | 5,304 |
Cash and cash equivalents and restricted cash — end of period | 14,346 | 13,117 |
Supplemental cash flow information:: | ||
Cash paid for interest | 1,790 | 1,354 |
Cash paid for income taxes | 21 | |
Supplemental noncash investing and financing activities: | ||
Note payable end of term payment accrued but unpaid | $ 3,625 | $ 2,375 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | 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] | Common Stock Warrants [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, 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, net of issuance (in shares) | 12,000 | ||||||||||||
Issuance of Preferred stock - Series B, net of issuance | $ 7,714 | $ 7,714 | |||||||||||
Preferred stock dividends | $ 14 | ||||||||||||
Preferred stock dividends | (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, 2023 | 52,354,450 | ||||||||||||
Beginning balance at Dec. 31, 2023 | $ 524 | 462,446 | $ 4,396 | (418,490) | (2,706) | 46,170 | |||||||
Issuance of common stock, net of issuance costs (in shares) | 7,112 | ||||||||||||
Stock option exercises | 37 | $ 37 | |||||||||||
Stock option exercises (in shares) | 13,125 | 13,125 | |||||||||||
Stock-based compensation expense | 845 | $ 845 | |||||||||||
Net loss | (6,251) | (6,251) | |||||||||||
Foreign currency translation adjustments | (148) | (148) | |||||||||||
Ending balance (in shares) at Mar. 31, 2024 | 52,374,687 | ||||||||||||
Ending balance at Mar. 31, 2024 | $ 524 | $ 463,328 | $ 4,396 | $ (424,741) | $ (2,854) | $ 40,653 |
Nature of Operations
Nature of Operations | 3 Months Ended |
Mar. 31, 2024 | |
Nature of Operations [Abstract] | |
Nature of Operations | 1. NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the “Company”), is a global pharmaceutical company that specializes in the commercialization and development of ophthalmic retinal pharmaceuticals. The Company was formed on June 4, 2003, 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 commercialized products are ILUVIEN ® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in the United States and 24 countries for the treatment of diabetic macular edema (“DME”) and YUTIQ ® (fluocinolone acetonide intravitreal implant) 0.18 mg, available in the U.S. for the treatment and prevention of non-infectious uveitis affecting the posterior segment of the eye (“NIU-PS”). 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 NIU-PS. The Company markets ILUVIEN directly in the U.S., Germany, the United Kingdom (“U.K.”), Portugal and Ireland. In addition, the Company has entered into various agreements under which distributors are providing or will provide regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Switzerland, Australia, New Zealand and several countries in the Middle East. In addition, the Company has granted an exclusive license to Ocumension Therapeutics (“Ocumension”) for the development and commercialization of the Company’s 0.19 mg fluocinolone acetonide intravitreal injection in China, East Asia and the Western Pacific. As of March 31, 2024, 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 certain Nordic countries. In the U.S., YUTIQ is indicated for the treatment and prevention of chronic NIU-PS of the eye. The Company has the rights to commercialize YUTIQ under a product rights agreement dated May 17, 2023 (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 NIU-PS (see Note 4). The Product Rights Agreement also excludes any rights to YUTIQ for the treatment and prevention of chronic NIU-PS 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. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2024 | |
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, 2023, and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 8, 2024 (the “2023 Form 10-K”). The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. As of March 31, 2024, and December 31, 2023, the Company had approximately $ 14.3 million and $ 12.1 million in cash and cash equivalents, respectively. The Company anticipates its commercial operations will generate sufficient cash flow, combined with the Company’s current financial assets, to fund all conditional and unconditional financial obligations for at least the next 12 months. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
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 2023 Form 10-K. 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 Business Combinations (Topic 805) – Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“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 to 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. Foreign Currency Translation The financial statements of each of the Company’s subsidiaries with a functional currency other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. Foreign currency transaction gains and losses are included in other (expense) income, net in the results of operations. Adoption of New Accounting Standards In June 2022, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2022-03, Fair Value Measurement (Topic 820) – Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard became effective for the Company on January 1, 2024. The adoption of this ASU did not have a material impact on the Company’s financial statements. In November 2023 the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures . This standard requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the entity’s CODM. The amendments in this update also expand the interim segment disclosure requirements. All disclosure requirements under this standard are also required for public entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this update are required to be applied on a retrospective basis. This standard became effective for the Company on January 1, 2024. The adoption of this ASU did not have a material impact on the Company’s financial statements and related disclosures. Accounting Standards Issued but Not Yet Effective In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”). This standard provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard is available until December 31, 2022. In December 2022, the FASB issued ASU No. 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, which extended the period of time preparers can utilize the reference rate reform relief guidance in ASU 2020-04. The guidance ensures the relief in ASU 2020-04 covers the period of time during which a significant number of modifications may take place and the ASU defers the sunset date of ASU 2020-04 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. In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative (“ASU 2023-06”). This standard modifies the disclosure or presentation requirements of a variety of topics and aligns requirements with the SEC’s existing disclosure requirements. ASU 2023-06 is effective on the date each amendment is removed from Regulation S-X or Regulation S-K with early adoption prohibited. The amendments in ASU 2023-06 will be applied prospectively in the consolidated financial statements. The Company is currently evaluating the timing of its adoption of this standard and the impact on its financial statements. In December 2023, ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) requires public business entities to disclose on an annual basis additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate for federal, state, and foreign income taxes. It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items exceeds a specified threshold. In addition, ASU 2023-09 requires disclosure pertaining to taxes paid, net of refunds received, to be disaggregated for federal, state, and foreign taxes and further disaggregated for specific jurisdictions to the extent the related amounts exceed a quantitative threshold. ASU 2023-09 is effective for the Company for the annual period beginning on January 1, 2025. Early adoption is permitted. ASU 2023-09 should be applied on a prospective basis. However, companies have the option to apply the standard retrospectively. The Company is currently evaluating the potential impact that this new standard will have on its financial statements and related disclosures. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 4. REVENUE RECOGNITION Overview The Company recognizes revenue when a customer obtains control of the related good or service pursuant to ASC 606, Revenue from Contracts with Customers . 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, 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 net sales price (“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. Product Revenue The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its “Customer(s)”). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues 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 transaction price, which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations, Group Purchasing Organizations, distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not 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 exchange of 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 the Interim Financial Statements , product returns have been minimal. Collaboration and License Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these agreements may 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. Accounts Receivable, net Accounts receivable are generated through sales primarily to major pharmaceutical distributors, pharmacies, hospitals and wholesalers. The Company does not require collateral from its customers for accounts receivable. The carrying amount of accounts receivable is reduced by an allowance for expected credit losses that reflects management’s best estimate of the amounts that will not be collected. Management considers many factors in assessing the need for an allowance for expected credit losses, including the length of time trade accounts receivable are past due, the customer’s ability to pay its obligation, customer types, credit worthiness and the condition of the general economy and the industry as a whole. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. As of March 31, 2024 and 2023, the Company had $ 0.2 million reserved for expected credit losses. During the three months ended March 31, 2024 and 2023, the Company reserved for $ 0.2 million and $ 0.9 million for expected credit losses, respectively. Allowance for doubtful accounts consisted of the following as of March 31, 2024 and 2023, respectively: March 31, 2024 2023 (In thousands) Beginning balance $ 1,222 $ — Provision for credit losses 176 871 Write-off of bad debt ( 1,212 ) ( 686 ) Ending Balance $ 186 $ 185 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Leases | 5. LEASES The Company evaluates all of its contracts to determine whether it is or contains a lease component under FASB ASC 842 – Leases (“ASC 842”). 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 determination and classification for existing 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 that it is not reasonably certain it will exercise any applicable renewal options. Accordingly, the Company has not recorded any liability for renewal options in these consolidated 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 March 31, 2024 and December 31, 2023 for the Company’s operating leases is as follows: March 31, December 31, 2024 2023 (In thousands) Non-current assets: Right-of-use assets, net $ 1,060 $ 1,124 Total lease assets $ 1,060 $ 1,124 Current liabilities: Accrued expenses $ 584 $ 634 Non-current liabilities: Other non-current liabilities 1,759 1,826 Total lease liabilities $ 2,343 $ 2,460 The Company’s operating lease cost for the three months ended March 31, 2024 and 2023 was $ 0.1 million for both periods, and is included in general and administrative expenses in its condensed consolidated statement of operations. As of March 31, 2024, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2024 (remaining) $ 489 2025 474 2026 488 2027 503 2028 518 Thereafter 534 Total 3,006 Less amount representing interest ( 663 ) Present value of minimum lease payments 2,343 Less current portion (as a portion of accrued expenses) ( 584 ) Non-current portion (as a portion of other non-current liabilities) $ 1,759 For the three months ended March 31, 2024 and 2023, cash paid for operating leases was $ 0.2 million for both periods. No right-of-use assets were obtained in connection with operating leases for the three months ended March 31, 2024 or 2023. As of March 31, 2024, the weighted average remaining lease terms of the Company’s operating leases was 5.5 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 March 31, 2024 and December 31, 2023 for the Company’s finance leases is as follows: March 31, December 31, 2024 2023 (In thousands) Non-current assets: Property and equipment, net $ 580 $ 554 Total lease assets $ 580 $ 554 Current liabilities: Finance lease obligations $ 220 $ 194 Non-current liabilities: Finance lease obligations - less current portion 256 256 Total lease liabilities $ 476 $ 450 Depreciation expense associated with property and equipment under finance leases was approximately $ 0.1 million for both the three months ended March 31, 2024 and 2023. Interest expense associated with finance leases was less than $ 0.1 million for both the three months ended March 31, 2024 and 2023. As of March 31, 2024, 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) 2024 (remaining) $ 259 2025 252 2026 144 2027 3 Total 658 Less amount representing interest ( 182 ) Present value of minimum lease payments 476 Less current portion ( 220 ) Non-current portion $ 256 Cash paid for finance leases was $ 0.1 million during both of the three months ended March 31, 2024 and 2023. The Company acquired $ 0.1 million of property and equipment in exchange for finance leases during both of the three months ended March 31, 2024 and 2023. As of March 31, 2024, the weighted average remaining lease terms of the Company’s finance leases was 1.3 years. The weighted average discount rate used to determine the finance lease liabilities was 10.1 %. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2024 | |
Inventory [Abstract] | |
Inventory | 6. INVENTORY Inventories are stated at the lower of cost or net realizable value with cost determined under the first in, first out (“FIFO”) method. Included in inventory costs are component parts, work-in-progress and finished goods. The Company relies on third-party manufacturers for the production of all inventory and does not capitalize any internal costs. The Company periodically reviews inventories for excess, obsolete or expiring inventory and writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value in the period in which the impairment is identified. As of March 31, 2024 and December 31, 2023, inventory consisted of the following: March 31, December 31, 2024 2023 (In thousands) Component parts (1) $ 554 $ 688 Work-in-process (2) 193 134 Finished goods 1,459 1,057 Total Inventory $ 2,206 $ 1,879 (1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or European Economic Area regulatory authorities. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2024 | |
Intangible Assets [Abstract] | |
Intangible Assets | 7. INTANGIBLE ASSETS ILUVIEN Intangible Asset As a result of the U.S. Food and Drug Administration’s approval of ILUVIEN in September 2014, the Company was required to pay a milestone payment of $ 25.0 million (the “EyePoint Milestone Payment”) to EyePoint in October 2014 (see Note 8). The gross carrying amount of the ILUVIEN intangible asset is $ 25.0 million, which is being amortized over approximately 13 years from the acquisition date. The amortization expense related to the ILUVIEN intangible asset was approximately $ 0.5 million for each of the three months ended March 31, 2024 and 2023. The net book value of the ILUVIEN intangible asset was $ 6.5 million and $ 7.0 million as of March 31, 2024 and December 31, 2023, respectively. The estimated remaining amortization of the ILUVIEN intangible asset as of March 31, 2024, is denoted in the following: Years Ending December 31 (In thousands) 2024 (remaining) $ 1,462 2025 1,940 2026 1,940 2027 1,191 Total $ 6,533 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 (where ILUVIEN is utilized), excluding any rights for the treatment and prevention of chronic NIU-PS 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 $ 75.0 million and will make four quarterly additional guaranteed payments to EyePoint Parent totaling $ 7.5 million in 2024. Also, the Company will pay royalties starting in 2025 through 2028 (see Note 8). The present value of the 2024 quarterly payments and the present value of estimated royalties payable t o EyePoint Parent for years 2025 to 2028 is included in the cost of the intangible the Company recorded. The estimated royalties will continue to be revalued at each reporting date until they are settled. As of March 31, 2024, the gross carrying amount of the YUTIQ intangible asset is $ 96.4 million, which is being amortized over 10 years. The net book value of the YUTIQ intangible asset was $ 87.9 million and $ 90.3 million as of March 31, 2024 and December 31, 2023, respectively. The amortization expense related to the YUTIQ intangible was $ 2.4 million for the three months ended March 31, 2024 . The estimated remaining amortization of the YUTIQ intangible asset as of March 31, 2024 is as follows (in thousands): Years Ending December 31 (In thousands) 2024 (remaining) $ 7,253 2025 9,627 2026 9,627 2027 9,627 2028 9,654 Thereafter 42,150 Total $ 87,938 |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2024 | |
License Agreements [Abstract] | |
License Agreements | 8. LICENSE AGREEMENTS EyePoint Agreements In February 2005, the Company entered into an agreement with EyePoint for the use of fluocinolone acetonide (“FAc”) in EyePoint’s proprietary insert technology. This agreement was subsequently amended several 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. On July 10, 2017, the Company and EyePoint entered into a Second Amended and Restated Collaboration Agreement (the “New Collaboration Agreement”), which amended and restated the EyePoint Agreement. The New Collaboration Agreement expanded the license to include uveitis, including NIU-PS, in Europe, the Middle East and Africa and also allows the Company to pursue an indication for NIU-PS for ILUVIEN in those territories. The New Collaboration Agreement converted the Company’s obligation to share 20 % of its net profits to a royalty payable on global net revenues of ILUVIEN. The Company began paying a 2 % royalty on net revenues and other related consideration to EyePoint on July 1, 2017. This royalty amount increased to 6 % effective December 12, 2018. Pursuant to the New Collaboration Agreement, the Company is required to pay an additional 2 % royalty on global net revenues and other related consideration in excess of $ 75 million in any year. On December 17, 2020, EyePoint entered into a royalty purchase agreement (the “SWK Agreement”) with SWK Funding, LLC (“SWK”). Pursuant to the SWK Agreement, EyePoint sold its interest in royalties that the Company is obligated to pay EyePoint under the New Collaboration Agreement. The Company is not a party to the SWK Agreement. In connection with a previous agreement with EyePoint, the Company was entitled to recover commercialization costs that were incurred prior to profitability of ILUVIEN and offset a portion of future payments owed to EyePoint in connection with sales of ILUVIEN with those accumulated commercialization costs, referred to as the “Future Offset.” Following the signing of the New Collaboration Agreement, the Company retained the right to recover up to $ 15.0 million of the Future Offset. In March 2019, pursuant to the New Collaboration Agreement, the Company forgave $ 5.0 million of the Future Offset in connection with the approval of ILUVIEN for NIU-PS in the U.K. As of March 31, 2024 and December 31, 2023, the balance of the Future Offset was approximately $ 6.4 million and $ 6.5 million, respectively, which was fully reserved. The Company is able to recover the balance of the Future Offset as a reduction of future royalties that would otherwise be owed to EyePoint by reducing the royalty from 6 % to 5.2 % for net revenues and other related consideration up to $ 75.0 million annually and from 8 % to 6.8 % for net revenues and other related consideration in excess of $ 75.0 million on an annual basis. On May 17, 2023, the Company entered into a product rights agreement with EyePoint Parent which grants the Company an exclusive and sublicensable right and license under EyePoint Parent’s and its affiliates’ interest in 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, where the Company already has such rights pursuant to the New Collaboration Agreement, and except for China, Hong Kong, Macau, Taiwan, Brunei, Burma (Myanmar), Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, South Korea, Thailand and Vietnam, where Ocumension holds a license from EyePoint Parent. Pursuant to the agreement, the Company paid EyePoint Parent an upfront payment of $ 75.0 million and will also make four quarterly guaranteed payments to EyePoint Parent totaling $ 7.5 million during 2024. The Company will also pay royalties to EyePoint Parent from 2025 to 2028 at a percentage of mid-to-low double digits of annual U.S. net sales of certain products (including YUTIQ and ILUVIEN) in excess of certain thresholds, beginning at $ 70.0 million in 2025, increasing annually thereafter. Upon making the quarterly payments in the aggregate amount of $ 7.5 million in 2024, the licenses and rights granted to the Company will automatically become perpetual and irrevocable. For the quarter ended March 31, 2024, the Company paid the first quarterly payment of $ 1.9 million. The present value of the 2024 quarterly payments and the present value of estimated royalties payable t o EyePoint Parent for years 2025 to 2028 is included in the cost of the intangible the Company recorded. The estimated royalties will continue to be revalued at each reporting date until they are settled. Concurrently in May 2023, the Company also 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 agreed-upon quantities of YUTIQ necessary for the Company to commercialize YUTIQ in the U.S. at certain cost-plus amounts, subject to adjustments. EyePoint Parent’s manufacture and supply of YUTIQ will be exclusive (subject to certain exceptions) until the Company has the ability to manufacture and supply YUTIQ for commercialization in the U.S. The term of the Supply Agreement is for a period of two years through May 2025 and thereafter automatically renews for successive one-year terms unless either party provides notice of non-renewal to the other party within a specified period of time prior to the beginning of the next automatic renewal term, provided that the Supply Agreement automatically terminates upon the successful completion of the transfer of manufacturing for YUTIQ to the Company or its designee. The Supply Agreement also automatically terminates upon termination of the Product Rights Agreement. The Company’s license rights to EyePoint’s proprietary delivery device could revert to EyePoint if the Company were to: (i) fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the EyePoint Agreement within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30 -day period; (iii) file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days; or (iv) notify EyePoint in writing of its decision to abandon its license with respect to a certain product using EyePoint’s proprietary insert technology. For the three months ended March 31, 2024 and 2023, the Company recognized approximately $ 0.9 million and $ 0.7 million of royalty expense, respectively, which is included in cost of goods sold. As of March 31, 2024 and 2023, approximately $ 0.9 million and $ 0.7 million of this royalty expense was included in the Company’s accounts payable, respectively. 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, 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 190 microgram 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 “Territory”). The Company received a nonrefundable upfront payment of $ 10.0 million from Ocumension HK and may in the future receive additional sales-based milestone payments totaling up to $ 89.0 million upon the achievement by Ocumension HK of certain specified sales milestones during the term of the License Agreement of the Product. 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. The term of the License Agreement 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 License 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 . For both of March 31, 2024 and December 31, 2023, the Company had approximately $ 0.4 million of deferred revenue under the Ocumension license agreement that will be recognized over the remaining term of the agreement once Ocumension begins to sell the Product under the License Agreement. Ocumension Share Purchase Agreement 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 15. |
Loan Agreements
Loan Agreements | 3 Months Ended |
Mar. 31, 2024 | |
Loan Agreements [Abstract] | |
Loan Agreements | 9. LOAN AGREEMENTS Loan Agreements with SLR Investment Corp. (formerly Solar Capital Ltd.) On January 5, 2018, the Company entered into a $ 40.0 million loan and security agreement with SLR Investment Corp. (“SLR,” also formerly known as Solar Capital Ltd.), as Collateral Agent, and the parties signatory thereto from time to time as “Lender(s),” including Solar Capital Ltd. in its capacity as a Lender (the “2018 Loan Agreement”) and a related exit fee agreement (the “2018 Exit Fee Agreement”). On December 31, 2019, the Company refinanced the 2018 Loan Agreement by entering into a $ 45.0 million loan and security agreement (the “2019 Loan Agreement”) and a related exit fee agreement (the “2019 Exit Fee Agreement”) with SLR, as Agent, and the parties signing the 2019 Loan Agreement from time to time as Lenders, including SLR in its capacity as a Lender. The Company has amended the 2019 Loan Agreement on multiple occasions, which are summarized as follows: On February 22, 2022, the Company entered into a Third Amendment to the 2019 Loan Agreement (the “Third Amendment”), which, among other things, amended the provisions relating to the minimum revenue amount that the Company must achieve at the end of each calendar quarter, as calculated on a trailing six-month basis (the “Revenue Covenant”). On December 7, 2022, the Company entered into a Fourth Amendment to the 2019 Loan Agreement (the “Fourth Amendment”), which, among other things, extended the amortization date from January 1, 2023 to April 1, 2023, and provided that such date might 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. The Fourth Amendment also amended the provisions relating to the Revenue Covenant effective with the first calendar quarter in 2023. On March 24, 2023, the Company entered into a Fifth Amendment to the 2019 Loan Agreement (the “Fifth Amendment”) and a related Fifth Amendment Exit Fee Agreement (the “2023 Exit Fee Agreement”) . Pursuant to the Fifth Amendment, the Lenders agreed to, among other things, (i) an additional tranche of $ 2.5 million to increase the Company’s existing term loan facility to $ 47.5 million, subject to certain closing conditions, (ii) extend availability of the amount of $ 15.0 million to be funded at the Lender’s sole discretion, and (iii) amended the Revenue Covenants to be effective for calendar quarters ending on or after March 31, 2023. On May 17, 2023, the Company entered into a Sixth Amendment to the 2019 Loan Agreement, (the “Sixth Amendment”). Pursuant to the Sixth Amendment, the Lenders agreed to, among other things, (i) an increase of the limit of availability from $ 15.0 million to $ 20.0 million, and (ii) amended the Revenue Covenants to be effective for calendar quarters ending on or after June 30, 2023. The Company received aggregate gross proceeds of $ 20.0 million upon execution of the Sixth Amendment. On March 6, 2024, Alimera entered into the Seventh Amendment to the 2019 Loan Agreement, (the “Seventh Amendment”). Pursuant to the Seventh Amendment, the Lenders agreed to, among other things, increase the amount available under the facility from $ 67.5 million to $ 72.5 million and funded an additional $ 5.0 million on March 6, 2024. 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 % or (ii) one-month SOFR, which will reset monthly. As of March 31, 2024 and December 31, 2023, the interest rate on the 2019 Loan Agreement was approximately 10.47 % and 10.50 %, respectively. 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 April 20, 2025, followed by monthly payments of principal and interest through the loan maturity date of April 30, 2028. The Company met such financial targets during the year ended December 31, 2023, and provided there are no events of default as defined by the Loan Agreement on or prior to April 20, 2025, the Company anticipates being able to extend the interest only period for an additional 12 months. The Company complied with the Revenue Covenant on March 31, 2024, expects to comply with the Revenue Covenant at the next reportable date, which is June 30, 2024, and the remainder of the Revenue Covenant through one year after these Interim Financial Statements are issued. Exit Fee Agreements 2018 Exit Fee Agreement Pursuant to the existing 2018 Exit Fee Agreement, the Company is obligated to pay an exit fee of up to $ 2.0 million upon the occurrence of an exit event, which generally means a “change in control” (as defined in the 2018 Exit Fee Agreement) and will survive the termination of the 2019 Loan Agreement and accompanying amendments with a term of 10 years. To the extent that the Company has not already paid the $ 2.0 million exit fee, the Company is also obligated to pay a fee of $ 1.0 million on achieving each of the following milestones: First, if the Company achieves revenues of $ 80.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third-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 $ 100.0 million 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 Pursuant to the existing 2019 Exit Fee Agreement, the Company is obligated to pay an exit fee of up to a $ 0.7 million upon the occurrence of an exit event, which generally means a “change in control” (as defined in the 2019 Exit Fee Agreement) and will survive the termination of the 2019 Loan Agreement and accompanying amendments with a term of 10 years. To the extent that the Company has not already paid the $ 0.7 million exit fee, the Company is obligated to pay a fee of $ 0.3 million on achieving each of the following milestones: First, if the Company achieves revenues of $ 75.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third-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 $ 95.0 million or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner. 2023 Exit Fee Agreement Pursuant to the existing 2023 Exit Fee Agreement, the Company is obligated to pay 1.5 % of the aggregate principal amount funded under the 2019 Loan Agreement and accompanying amendments (principal amount currently is $ 72.5 million) as an exit fee upon the occurrence of an exit event, which generally means a change in control, and will survive the termination of the 2019 Loan Agreement and accompanying amendments and has a term of 10 years. To the extent that the Company has not already paid the 1.5 % (currently $ 1.1 million) of the aggregate principal amount funded under the 2019 Loan Agreement and accompanying amendments, the Company is obligated to pay a fee of 1.5 % of the aggregate principal amount funded under the 2019 Loan Agreement and accompanying amendments upon achieving the following milestone: If the Company achieves revenues of $ 82.5 million or more from the sale of its ILUVIEN product in the ordinary course of business to third-party customers, measured on a trailing 12 -month basis during the term of the agreement, tested at the end of each month. On May 17, 2023, the Company amended the revenue criteria for all three exit fee agreements to include the sales of YUTIQ in the ordinary course of business to third-party customers. The exit fees payable pursuant to the Company’s existing exit fee agreements will not exceed $ 3.8 million in total. During the fourth quarter of 2023, the Company met one revenue milestone under the 2018 Exit Fee Agreement and one revenue milestone under the 2019 Exit Fee Agreement. Accordingly, the Company recognized $ 1.3 million of interest expense during the fourth quarter of 2023. For the three months ended March 31, 2024, the Company met one revenue milestone under the 2023 Exit Fee Agreement and recognized $ 1.1 million of interest expense. As of March 31, 2024, there was $ 2.4 million in exit fees included in accounts payable. Modification of Debt The Company capitalized approximately $ 2.6 million of deferred financing costs in connection with the Fifth and Sixth Amendments during 2023. In connection with the Seventh Amendment, the Company capitalized less than $ 0.1 million of deferred financing costs. Extinguishment of Debt In accordance with the guidance in ASC Subtopic 470-50, Debt – Modifications and Extinguishments , the Company entered into and accounted for the Sixth Amendment as an extinguishment of debt. The Company recognized a loss on extinguishment of $ 1.1 million 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 March 31, 2024 and December 31, 2023. |
Earnings (Loss) Per Share
Earnings (Loss) Per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings (Loss) Per Share [Abstract] | |
Earnings (Loss) Per Share | 10. EARNINGS (LOSS) PER SHARE The Company follows ASC 260, Earnings Per Share (“ASC 260”), which requires the reporting of both basic and diluted earnings per share (“EPS”). 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. The Company’s preferred stock for Series A and Series B were eliminated in 2023 (see Note 11). Basic net loss per share is calculated by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. For purposes of the diluted net loss per share calculation, stock options, unvested restricted stock units and Employee Stock Purchase Plan (“ESPP”) shares are considered to be common stock equivalents but are excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive; therefore, basic and diluted net loss per share were the same for all periods presented as a result of the Company’s net loss. The following common stock equivalents were excluded from the computation of diluted net loss per share for the years ended March 31, 2024 and 2023, respectively, because their inclusion would have had anti-dilutive effect : March 31, 2024 2023 Series B convertible preferred stock — 5,714,286 Common stock warrants 1,600,000 5,714,286 Stock options 3,239,384 1,216,953 Restricted stock units ( “ RSUs ” ) 1,769,638 35,050 Total 6,609,022 12,680,575 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 3 Months Ended |
Mar. 31, 2024 | |
Stockholder' Equity (Deficit) [Abstract] | |
Stockholder' Equity (Deficit) | 11. STOCKHOLDERS’ EQUITY (DEFICIT) 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 $ 40.0 million prior to the payment of approximately $ 0.6 million of related issuance costs. The Company subsequently repurchased all of its outstanding Series A Preferred Stock on March 24, 2023. Following such repurchase, the Company filed a certificate of elimination of the Series A Preferred Stock with the Secretary of State of the State of Delaware. The authorized shares of Series A Preferred Stock were returned to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series. Series B Convertible Preferred Stock In March 2023, the Company issued and sold an aggregate of 12,000 shares of Series B Convertible Preferred Stock at a purchase price of $ 1,000 per share and warrants to purchase common stock for aggregate gross proceeds of $ 12.0 million. In May 2023, the Company issued and sold an additional aggregate of 67,000 shares of Series B Convertible Preferred Stock at a purchase price of $ 1,000 per share and warrants to purchase common stock for aggregate gross proceeds of $ 67.0 million. On August 1, 2023, the Company amended the Certificate of Designation of Series B Convertible Preferred Stock to allow for the issuance of pre-funded warrants (“Pre-Funded Warrants”) to certain holders of Series B Preferred Stock. Prior to such amendment, the Certificate of Designation provided that the Series B Preferred Stock (including any accrued but unpaid dividends) would automatically convert at the then-applicable conversion price (the “Mandatory Conversion”) in full into the Company’s common stock following stockholder approval. Stockholder approval was received at the Company’s 2023 annual meeting of stockholders held on August 1, 2023, and the Company designated August 15, 2023, as the date for the Mandatory Conversion of the Series B Convertible Preferred Stock into its common stock and Pre-Funded Warrants to purchase common stock. In connection with the Mandatory Conversion, the Company issued 43,617,114 shares of common stock and Pre-Funded Warrants exercisable for 2,000,000 shares of common stock at an exercise price of $ 0.01 per share to the holders of the Series B Convertible Preferred Stock. Following the Mandatory Conversion, no shares of the Series B Convertible Preferred Stock remain outstanding. The authorized shares of Series B Preferred Stock were returned to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series. Common and Preferred Stock The Company’s authorized capital stock consists of (a) 150,000,000 shares of common stock, par value $ 0.01 per share; and (b) 10,000,000 shares of preferred stock, par value $ 0.01 per share. At March 31, 2024 and December 31, 2023, there were 52,374,687 and 52,354,450 shares of common stock issued and outstanding, respectively. At March 31, 2024 and December 31, 2023, there were no shares of preferred stock issued and outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | 12. STOCK-BASED COMPENSATION 2023 Equity Incentive Plan On August 1, 2023, the Company’s stockholders approved the 2023 Equity Incentive Plan (the “2023 Plan”), which replaced the 2019 Omnibus Incentive Plan (the “2019 Plan”). The 2023 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 August 1, 2023 (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 Plan will increase by a number of shares equal to 6 % of the number of outstanding shares of common stock. Under the 2023 Plan, the Compensation Committee of the Company’s board of directors is authorized to grant equity-based incentive awards that include stock options, restricted stock units (“RSUs”), shares of restricted stock (“RSS”) and performance-based restricted stock units (“PSUs”) to officers, directors, employees and contractors. Equity-based awards are also outstanding under the Company’s 2019 and 2010 equity incentive plans, although no new awards can be granted under either plan. The Company’s equity incentive plans permit the issuance of various types of awards including but not limited to stock options, restricted stock, RSUs and PSUs. 2024 Equity Inducement Plan On February 8, 2024, upon recommendation of the Compensation Committee of the Board of Directors of the Company, they approved and adopted the 2024 Equity Inducement Plan (the “2024 Equity Inducement Plan”), and subject to the adjustment provisions of the 2024 Equity Inducement Plan, reserved 800,000 shares of the Company’s common stock, par value $ 0.01 per share, for issuance of equity awards under the 2024 Equity Inducement Plan. The 2024 Equity Inducement Plan was approved and adopted without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2024 Equity Inducement Plan provides for grants of non-statutory stock options, RSUs, PSUs, stock appreciation rights, and restricted shares (each, an “Inducement Award”). In addition, the Compensation Committee of the Board of Directors also approved various forms of stock-based awards. The terms and conditions of the 2024 Equity Inducement Plan are intended to comply with the Nasdaq inducement award rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, the only persons eligible to receive grants of Inducement Awards are individuals who were not previously employees or directors of the Company (or following a bona fide period of non-employment), as an inducement material to the individuals’ entry into employment with the Company. An aggregate 460,106 and 142,511 shares of the Company’s common stock were available for issuance of new awards granted under the Company’s equity incentive plans as of March 31, 2024 and December 31, 2023, respectively. Stock Options Options granted to employees typically become exercisable over a four-year vesting period and have a ten-year contractual term. Initial options granted to directors typically vest over a four-year period and have a ten-year contractual term. Annual option grants to directors typically vest in full on the date of the Company’s next annual meeting of shareholders and have a ten-year contractual term. During the three months ended March 31, 2024 and 2023, the Company recorded compensation expense related to stock options of approximately $ 0.5 million and $ 0.2 million, respectively. As of March 31, 2024, the total unrecognized compensation cost related to non-vested stock options granted was $ 4.9 million and is expected to be recognized over a weighted average period of 3.27 years. The following table presents a summary of stock option activity for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 3,194,574 7.42 1,175,339 19.03 Grants 99,500 4.18 100,402 2.73 Forfeitures and expirations ( 41,565 ) 4.09 ( 58,788 ) 11.85 Exercises ( 13,125 ) 2.82 — — Options outstanding at period end 3,239,384 7.38 1,216,953 18.03 Options exercisable at period end 1,117,599 14.89 867,650 23.38 Weighted average per share fair value of options granted during the period $ 2.86 $ 1.88 The following table provides additional information related to outstanding stock options as of March 31, 2024: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 3,239,384 7.38 8.17 years 1,491 Exercisable 1,117,599 14.89 5.69 years 260 Outstanding, vested and expected to vest 2,747,507 8.09 7.92 years 1,222 The following table provides additional information related to outstanding stock options as of December 31, 2023: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 3,194,574 7.42 8.35 years 2,460 Exercisable 993,037 16.34 5.40 years 258 Outstanding, vested and expected to vest 2,887,226 7.84 8.20 years 2,164 As of March 31, 2024, 182,906 shares remain available for grant under the 2023 Plan. Restricted Stock and Restricted Stock Units (“RSUs”) The following table presents a summary of restricted stock and RSUs activity for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 1,217,076 2.35 73,594 4.98 Grants 223,300 3.77 632,050 1.39 Vested restricted stock and RSUs ( 159,256 ) 1.82 ( 20,468 ) 4.98 Forfeitures — — — — Restricted stock and RSUs outstanding at period end 1,281,120 2.66 685,176 1.67 Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation (“ASC 718”) was $ 0.4 million and less than $ 0.1 million for the three months ended March 31, 2024 and 2023. As of March 31, 2024, the total unrecognized compensation cost related to restricted stock and RSUs was $ 3.2 million and is expected to be recognized over a weighted average period of 3.40 years. Performance-based restricted stock units (“PSUs”) During the fourth quarter of 2023, the Company began granting performance-based PSUs that will settle in stock. PSUs awarded to employees have a three-year performance period and vest equally upon the achievement of annual performance measures established at the date of grant. Participants may ultimately earn between zero and 100 % of the number of PSUs granted based on the degree of achievement of the performance metrics. If zero PSUs vest in a given year because the annual performance metric was not achieved, such PSUs will not be eligible to vest in a later year for the participant. The following table summarizes the PSUs activity for three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Performance stock units outstanding at beginning of period 625,000 2.99 — — Grants 275,000 3.77 — — Vested — — — — Forfeitures — — — — Restricted stock and RSUs outstanding at period end 900,000 3.23 — — The Company recognized no compensation costs related to the PSUs during the three months ended March 31, 2024 and 2023, as it was not deemed probable that any performance conditions would be achieved. As of March 31, 2024, there was approximately $ 2.7 million of total unrecognized compensation cost related to outstanding PSUs that could be recognized over a weighted average period of 2.90 years if the PSUs vest. Employee Stock Purchase Plan During the three months ended March 31, 2024 and 2023, the Company recorded compensation expense related to its employee stock purchase plan of less than $ 0.1 million for each period. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2024 | |
Income Taxes [Abstract] | |
Income Taxes | 13. 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. Significant management judgment is involved in determining the provision for income taxes, deferred tax assets and liabilities, and any valuation allowance recorded against net deferred tax assets. Due to uncertainties with respect to the realization of U.S. deferred tax assets due to the history of operating losses, a valuation allowance has been established against the entire net U.S. deferred tax asset balance. The valuation allowance is based on management’s estimates of taxable income in the jurisdictions in which the Company operates and the period over which deferred tax assets will be recoverable. If actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact the Company’s financial position and results of operations. 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 three months ended March 31, 2024, the Company has recorded a tax benefit of $ 32,000 . The effective tax rate for the period differs from the statutory tax rate for the period primarily due to the effects of valuation allowances on net operating losses and on other deferred tax assets. As of December 31, 2023, the Company had federal NOL carry-forwards of approximately $ 146.8 million and state NOL carry-forwards of approximately $ 106.8 million, subject to further limitation based upon the final results of the Company’s analyses of Internal Revenue Code Sections 382 and 383. These NOLs are available to reduce future income unless otherwise taxable. 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 2043. Sections 382 and 383 of the Internal Revenue Code limit the annual use of NOL carry-forwards and tax credit carry-forwards, respectively, following an ownership change. NOL carry-forwards may be subject to annual limitations under Internal Revenue Code Section 382 (“Section 382”) (or comparable provisions of state law) if certain changes in ownership were to occur. The Company periodically evaluates its 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. If it is determined that significant ownership changes have occurred since the Company generated its NOL carry-forwards, the Company may be subject to annual limitations on the use of these NOL carry-forwards under Section 382 (or comparable provisions of state law). The Company has determined that Section 382 changes in ownership occurred in late 2015 and in 2023. As a result of these changes in ownerships, the Company estimated that substantially all of its federal and state NOL carry-forwards and tax credits generated prior to the 2023 change in ownership will be subject to Section 382 limitations and may not be fully utilized in the future. The Company is currently in the process of evaluating the Section 382 impact to determine if a write-off is necessary. The reduction to the Company’s NOL deferred tax asset due to the annual Section 382 limitation and the NOL carryforward period would result in an offsetting reduction in valuation allowance recorded against the NOL deferred tax asset. 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, 2023 and 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 utilized $ 1.1 million of this carryforward as of December 31, 2023. The Company expects the remaining 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. 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. |
Segment Information
Segment Information | 3 Months Ended |
Mar. 31, 2024 | |
Segment Information [Abstract] | |
Segment Information | 14. SEGMENT INFORMATION 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 Company’s CODM manages and evaluates our 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 Company’s CODM 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. During the three months ended March 31, 2024 and 2023, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 63 % and 56 % of the Company’s consolidated product revenues, respectively. These same two customers within the U.S. segment accounted for approximately 70 % of the Company’s consolidated accounts receivable at March 31, 2024 and at December 31, 2023. Internationally, our distributors produced approximately 53 % and 46 % of our international product revenues during the three months ended March 31, 2024 and 2023, respectively. The following table presents a summary of the Company’s reporting segments for the three months ended March 31, 2024 and 2023: Three Months Ended March 31, 2024 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 14,552 $ 8,459 $ — $ — $ 23,011 Cost of goods sold, excluding depreciation and amortization ( 1,424 ) ( 1,929 ) — — ( 3,353 ) Gross profit 13,128 6,530 — — 19,658 Operating expenses: Research, development and medical affairs expenses 1,300 684 2,326 51 4,361 General and administrative expenses 568 561 3,657 646 5,432 Sales and marketing expenses 6,953 1,548 434 147 9,082 Depreciation and amortization — — — 3,085 3,085 Total operating expenses 8,821 2,793 6,417 3,929 21,960 Segment income (loss) from operations 4,307 3,737 ( 6,417 ) ( 3,929 ) ( 2,302 ) Other income and expenses, net — — — ( 3,981 ) ( 3,981 ) Net loss before taxes $ ( 6,283 ) Three Months Ended March 31, 2023 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 7,582 $ 5,964 $ — $ — $ 13,546 Cost of goods sold, excluding depreciation and amortization ( 905 ) ( 1,123 ) — — ( 2,028 ) Gross profit 6,677 4,841 — — 11,518 Operating expenses: Research, development and medical affairs expenses 1,162 756 2,224 22 4,164 General and administrative expenses 1,184 716 2,116 155 4,171 Sales and marketing expenses 4,274 1,415 66 49 5,804 Depreciation and amortization — — — 681 681 Total operating expenses 6,620 2,887 4,406 907 14,820 Segment income (loss) from operations 57 1,954 ( 4,406 ) ( 907 ) ( 3,302 ) Other income and expenses, net — — — ( 1,666 ) ( 1,666 ) Net loss before taxes $ ( 4,968 ) |
Other Agreements with Ocumensio
Other Agreements with Ocumension | 3 Months Ended |
Mar. 31, 2024 | |
Other Agreements with Ocumension [Abstract] | |
Other Agreements with Ocumension | 15. OTHER AGREEMENTS WITH OCUMENSION Warrant Subscription Agreement On April 14, 2021, the Company entered into the warrant agreement with Ocumension 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. The fair value of the warrants are included on the balance sheet and revalued at each of the Company’s reporting dates with fluctuations being booked through the Company’s statement of operations. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value [Abstract] | |
Fair Value | 16. FAIR VALUE The Company applies FASB ASC 820, Fair Value Measurements (“ASC 820”), in determining the fair value of certain assets and liabilities. ASC 820 defines fair value and establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are described below: Level 1 – Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 2 – Valuations based on quoted prices in markets that are not active or for which all significant inputs are observable, either directly or indirectly. Level 3 – Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable. Pursuant to the Company’s warrant agreement with Ocumension, the Company has the right to exercise the warrants at its option, which are considered to be derivative instruments and classified as non-current warrant assets. The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in the fair value during each reporting period are reported in the consolidated statement of operations. There have been no changes to the valuation methods during the three months ended March 31, 2024 or 2023. The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company’s notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The following fair value table presents information about certain of the Company’s assets measured at fair value on a recurring basis: March 31, 2024 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 6 $ — $ 6 Assets measured at fair value $ — $ 6 $ — $ 6 December 31, 2023 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 52 $ — $ 52 Assets measured at fair value $ — $ 52 $ — $ 52 (1) The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in this value each reporting period are reported in the condensed consolidated statement of operations . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policy) | 3 Months Ended |
Mar. 31, 2024 | |
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 Business Combinations (Topic 805) – Accounting for Contract Assets and Contract Liabilities from Contracts with Customers (“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 to 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. |
Foreign Currency Translation | Foreign Currency Translation The financial statements of each of the Company’s subsidiaries with a functional currency other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income (loss) in stockholders’ equity. Foreign currency transaction gains and losses are included in other (expense) income, net in the results of operations. |
Adoption of New Accounting Standards and Accounting Standards Issued but Not Yet Effective | Adoption of New Accounting Standards In June 2022, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2022-03, Fair Value Measurement (Topic 820) – Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions . This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard became effective for the Company on January 1, 2024. The adoption of this ASU did not have a material impact on the Company’s financial statements. In November 2023 the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures . This standard requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items to reconcile to segment profit or loss and the title and position of the entity’s CODM. The amendments in this update also expand the interim segment disclosure requirements. All disclosure requirements under this standard are also required for public entities with a single reportable segment. This standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted and the amendments in this update are required to be applied on a retrospective basis. This standard became effective for the Company on January 1, 2024. The adoption of this ASU did not have a material impact on the Company’s financial statements and related disclosures. Accounting Standards Issued but Not Yet Effective In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2020-04”). This standard provides optional expedients and exceptions for applying U.S. GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard is available until December 31, 2022. In December 2022, the FASB issued ASU No. 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, which extended the period of time preparers can utilize the reference rate reform relief guidance in ASU 2020-04. The guidance ensures the relief in ASU 2020-04 covers the period of time during which a significant number of modifications may take place and the ASU defers the sunset date of ASU 2020-04 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. In October 2023, the FASB issued ASU No. 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative (“ASU 2023-06”). This standard modifies the disclosure or presentation requirements of a variety of topics and aligns requirements with the SEC’s existing disclosure requirements. ASU 2023-06 is effective on the date each amendment is removed from Regulation S-X or Regulation S-K with early adoption prohibited. The amendments in ASU 2023-06 will be applied prospectively in the consolidated financial statements. The Company is currently evaluating the timing of its adoption of this standard and the impact on its financial statements. In December 2023, ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”) requires public business entities to disclose on an annual basis additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate for federal, state, and foreign income taxes. It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items exceeds a specified threshold. In addition, ASU 2023-09 requires disclosure pertaining to taxes paid, net of refunds received, to be disaggregated for federal, state, and foreign taxes and further disaggregated for specific jurisdictions to the extent the related amounts exceed a quantitative threshold. ASU 2023-09 is effective for the Company for the annual period beginning on January 1, 2025. Early adoption is permitted. ASU 2023-09 should be applied on a prospective basis. However, companies have the option to apply the standard retrospectively. The Company is currently evaluating the potential impact that this new standard will have on its financial statements and related disclosures. |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Revenue Recognition [Abstract] | |
Allowance for Doubtful Accounts | March 31, 2024 2023 (In thousands) Beginning balance $ 1,222 $ — Provision for credit losses 176 871 Write-off of bad debt ( 1,212 ) ( 686 ) Ending Balance $ 186 $ 185 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Leases [Abstract] | |
Summary of Operating Leases Supplemental Balance Sheet Information | March 31, December 31, 2024 2023 (In thousands) Non-current assets: Right-of-use assets, net $ 1,060 $ 1,124 Total lease assets $ 1,060 $ 1,124 Current liabilities: Accrued expenses $ 584 $ 634 Non-current liabilities: Other non-current liabilities 1,759 1,826 Total lease liabilities $ 2,343 $ 2,460 |
Schedule of Future Minimum Operating Lease Payments | Years Ending December 31 (In thousands) 2024 (remaining) $ 489 2025 474 2026 488 2027 503 2028 518 Thereafter 534 Total 3,006 Less amount representing interest ( 663 ) Present value of minimum lease payments 2,343 Less current portion (as a portion of accrued expenses) ( 584 ) Non-current portion (as a portion of other non-current liabilities) $ 1,759 |
Summary of Finance Leases Supplemental Balance Sheet Information | March 31, December 31, 2024 2023 (In thousands) Non-current assets: Property and equipment, net $ 580 $ 554 Total lease assets $ 580 $ 554 Current liabilities: Finance lease obligations $ 220 $ 194 Non-current liabilities: Finance lease obligations - less current portion 256 256 Total lease liabilities $ 476 $ 450 |
Schedule of Future Minimum Finance Lease Payments | Years Ending December 31 (In thousands) 2024 (remaining) $ 259 2025 252 2026 144 2027 3 Total 658 Less amount representing interest ( 182 ) Present value of minimum lease payments 476 Less current portion ( 220 ) Non-current portion $ 256 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory [Abstract] | |
Schedule of Inventory | March 31, December 31, 2024 2023 (In thousands) Component parts (1) $ 554 $ 688 Work-in-process (2) 193 134 Finished goods 1,459 1,057 Total Inventory $ 2,206 $ 1,879 (1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or European Economic Area regulatory authorities. |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
ILUVIEN Intangible Asset [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Future Amortization | Years Ending December 31 (In thousands) 2024 (remaining) $ 1,462 2025 1,940 2026 1,940 2027 1,191 Total $ 6,533 |
YUTIQ Intangible Asset [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Future Amortization | Years Ending December 31 (In thousands) 2024 (remaining) $ 7,253 2025 9,627 2026 9,627 2027 9,627 2028 9,654 Thereafter 42,150 Total $ 87,938 |
Earnings (Loss) Per Share (Tabl
Earnings (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings (Loss) Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | March 31, 2024 2023 Series B convertible preferred stock — 5,714,286 Common stock warrants 1,600,000 5,714,286 Stock options 3,239,384 1,216,953 Restricted stock units ( “ RSUs ” ) 1,769,638 35,050 Total 6,609,022 12,680,575 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Stock-Based Compensation [Abstract] | |
Summary of Stock Option Activity | Three Months Ended March 31, 2024 2023 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 3,194,574 7.42 1,175,339 19.03 Grants 99,500 4.18 100,402 2.73 Forfeitures and expirations ( 41,565 ) 4.09 ( 58,788 ) 11.85 Exercises ( 13,125 ) 2.82 — — Options outstanding at period end 3,239,384 7.38 1,216,953 18.03 Options exercisable at period end 1,117,599 14.89 867,650 23.38 Weighted average per share fair value of options granted during the period $ 2.86 $ 1.88 |
Summary of Additional Stock Option Transactions | Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 3,239,384 7.38 8.17 years 1,491 Exercisable 1,117,599 14.89 5.69 years 260 Outstanding, vested and expected to vest 2,747,507 8.09 7.92 years 1,222 The following table provides additional information related to outstanding stock options as of December 31, 2023: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 3,194,574 7.42 8.35 years 2,460 Exercisable 993,037 16.34 5.40 years 258 Outstanding, vested and expected to vest 2,887,226 7.84 8.20 years 2,164 |
Summary of Restricted Stock and Restricted Stock Unit Transactions | Three Months Ended March 31, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Restricted stock and RSUs outstanding at beginning of period 1,217,076 2.35 73,594 4.98 Grants 223,300 3.77 632,050 1.39 Vested restricted stock and RSUs ( 159,256 ) 1.82 ( 20,468 ) 4.98 Forfeitures — — — — Restricted stock and RSUs outstanding at period end 1,281,120 2.66 685,176 1.67 |
Summary of Performance-Based Restricted Stock Unit | Three Months Ended March 31, 2024 2023 Weighted Weighted Average Average Grant Date Grant Date Shares Fair Value ($) Shares Fair Value ($) Performance stock units outstanding at beginning of period 625,000 2.99 — — Grants 275,000 3.77 — — Vested — — — — Forfeitures — — — — Restricted stock and RSUs outstanding at period end 900,000 3.23 — — |
Segment Information (Tables)
Segment Information (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Segment Information [Abstract] | |
Summary of Operations by Segment | Three Months Ended March 31, 2024 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 14,552 $ 8,459 $ — $ — $ 23,011 Cost of goods sold, excluding depreciation and amortization ( 1,424 ) ( 1,929 ) — — ( 3,353 ) Gross profit 13,128 6,530 — — 19,658 Operating expenses: Research, development and medical affairs expenses 1,300 684 2,326 51 4,361 General and administrative expenses 568 561 3,657 646 5,432 Sales and marketing expenses 6,953 1,548 434 147 9,082 Depreciation and amortization — — — 3,085 3,085 Total operating expenses 8,821 2,793 6,417 3,929 21,960 Segment income (loss) from operations 4,307 3,737 ( 6,417 ) ( 3,929 ) ( 2,302 ) Other income and expenses, net — — — ( 3,981 ) ( 3,981 ) Net loss before taxes $ ( 6,283 ) Three Months Ended March 31, 2023 U.S. International Operating Cost Other Consolidated (In thousands) Net revenue $ 7,582 $ 5,964 $ — $ — $ 13,546 Cost of goods sold, excluding depreciation and amortization ( 905 ) ( 1,123 ) — — ( 2,028 ) Gross profit 6,677 4,841 — — 11,518 Operating expenses: Research, development and medical affairs expenses 1,162 756 2,224 22 4,164 General and administrative expenses 1,184 716 2,116 155 4,171 Sales and marketing expenses 4,274 1,415 66 49 5,804 Depreciation and amortization — — — 681 681 Total operating expenses 6,620 2,887 4,406 907 14,820 Segment income (loss) from operations 57 1,954 ( 4,406 ) ( 907 ) ( 3,302 ) Other income and expenses, net — — — ( 1,666 ) ( 1,666 ) Net loss before taxes $ ( 4,968 ) |
Fair Value (Tables)
Fair Value (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value [Abstract] | |
Fair Value of Assets and Liabilities | March 31, 2024 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 6 $ — $ 6 Assets measured at fair value $ — $ 6 $ — $ 6 December 31, 2023 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 52 $ — $ 52 Assets measured at fair value $ — $ 52 $ — $ 52 (1) The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in this value each reporting period are reported in the condensed consolidated statement of operations |
Nature of Operations (Narrative
Nature of Operations (Narrative) (Details) - ILUVIEN [Member] | Mar. 31, 2024 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 |
Basis of Presentation (Narrativ
Basis of Presentation (Narrative) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 |
Basis of Presentation [Abstract] | ||||
Cash and cash equivalents | $ 14,346 | $ 12,090 | $ 13,117 | $ 5,304 |
Revenue Recognition (Narrative)
Revenue Recognition (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Period before expiration date returns are accepted | 3 months | |
Period after expiration date returns are accepted | 1 year | |
Accounts receivable, reserved for expected credit losses | $ 200 | $ 200 |
Provision for credit losses | $ 176 | $ 871 |
Minimum [Member] | ||
Customer payment obligation, period | 30 days | |
Maximum [Member] | ||
Customer payment obligation, period | 120 days |
Revenue Recognition (Allowance
Revenue Recognition (Allowance for Doubtful Accounts) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenue Recognition [Abstract] | ||
Beginning balance | $ 1,222 | |
Provision for credit losses | 176 | $ 871 |
Write-off of bad debt | (1,212) | (686) |
Ending balance | $ 186 | $ 185 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 100,000 | $ 100,000 |
Cash paid for leases | 200,000 | 200,000 |
Right-of-use asset obtained in exchange for operating lease liability | $ 0 | 0 |
Weighted average remaining lease term | 5 years 6 months | |
Weighted average discount rate, leases | 9.50% | |
Depreciation expense property and equipment under finance leases | $ 100,000 | 100,000 |
Finance lease interest expense | 100,000 | 100,000 |
Cash paid for finance leases | 100,000 | 100,000 |
Property and equipment acquired under finance leases | $ 100,000 | $ 100,000 |
Finance lease, weighted average remaining term | 1 year 3 months 18 days | |
Finance lease, weighted average discount rate | 10.10% | |
Minimum [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 1 year | |
Maximum [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 8 years |
Leases (Summary of Operating Le
Leases (Summary of Operating Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Non-current assets: | ||
Total lease assets | $ 1,060 | $ 1,124 |
Current liabilities: | ||
Accrued expenses | $ 584 | $ 634 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | Accrued Liabilities, Current |
Non-current liabilities: | ||
Other non-current liabilities | $ 1,759 | $ 1,826 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Total lease liabilities | $ 2,343 | $ 2,460 |
Leases (Schedule of Future Mini
Leases (Schedule of Future Minimum Operating Lease Payments) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Leases [Abstract] | ||
2024 (remaining) | $ 489 | |
2025 | 474 | |
2026 | 488 | |
2027 | 503 | |
2028 | 518 | |
Thereafter | 534 | |
Total | 3,006 | |
Less amount representing interest | (663) | |
Total lease liabilities | 2,343 | $ 2,460 |
Less current portion (as a portion of accrued expenses) | $ (584) | $ (634) |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued Liabilities, Current | Accrued Liabilities, Current |
Non-current portion (as a portion of other non-current liabilities) | $ 1,759 | $ 1,826 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Leases (Summary of Finance Leas
Leases (Summary of Finance Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Non-current assets: | ||
Total lease assets | $ 580 | $ 554 |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Property, Plant and Equipment, Net | Property, Plant and Equipment, Net |
Current liabilities: | ||
Finance lease obligations | $ 220 | $ 194 |
Non-current liabilities: | ||
Finance lease obligations - less current portion | $ 256 | $ 256 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Total lease liabilities | $ 476 | $ 450 |
Leases (Schedule of Future Mi_2
Leases (Schedule of Future Minimum Finance Lease Payments) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Leases [Abstract] | ||
2024 (remaining) | $ 259 | |
2025 | 252 | |
2026 | 144 | |
2027 | 3 | |
Total | 658 | |
Less amount representing interest | (182) | |
Total lease liabilities | 476 | $ 450 |
Less current portion | (220) | (194) |
Non-current portion | $ 256 | $ 256 |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory | ||
Component parts | $ 554 | $ 688 |
Work-in-process | 193 | 134 |
Finished goods | 1,459 | 1,057 |
Total inventory | $ 2,206 | $ 1,879 |
Intangible Assets (Narrative) (
Intangible Assets (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
May 17, 2023 | May 17, 2021 | Oct. 31, 2014 | Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2024 | Dec. 31, 2023 | |
Finite-Lived Intangible Assets [Line Items] | |||||||
Net intangible assets | $ 94,471 | $ 97,355 | |||||
Upfront payment | $ 75,000 | ||||||
ILUVIEN Intangible Asset [Member] | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Gross intangible assets | $ 25,000 | ||||||
Useful life (in years) | 13 years | ||||||
Amortization of intangible assets | $ 500 | $ 500 | |||||
Net intangible assets | 6,533 | 7,000 | |||||
YUTIQ Intangible Asset [Member] | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Gross intangible assets | $ 96,400 | ||||||
Useful life (in years) | 10 years | ||||||
Amortization of intangible assets | $ 2,400 | ||||||
Net intangible assets | 87,938 | $ 90,300 | |||||
Forecast [Member] | Product Rights [Member] | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Milestone payment after the first product approved by the FDA | $ 7,500 | ||||||
Eyepoint License Agreement [Member] | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Milestone payment after the first product approved by the FDA | $ 25,000 | $ 1,900 | |||||
Eyepoint License Agreement [Member] | Product Rights [Member] | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Upfront payment | $ 75,000 | ||||||
Eyepoint License Agreement [Member] | Forecast [Member] | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Milestone payment after the first product approved by the FDA | 7,500 | ||||||
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 |
Intangible Assets (Future Amort
Intangible Assets (Future Amortization) (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Total | $ 94,471 | $ 97,355 |
ILUVIEN Intangible Asset [Member] | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2024 (remaining) | 1,462 | |
2025 | 1,940 | |
2026 | 1,940 | |
2027 | 1,191 | |
Total | 6,533 | 7,000 |
YUTIQ Intangible Asset [Member] | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2024 (remaining) | 7,253 | |
2025 | 9,627 | |
2026 | 9,627 | |
2027 | 9,627 | |
2028 | 9,654 | |
Thereafter | 42,150 | |
Total | $ 87,938 | $ 90,300 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||||||
May 17, 2023 USD ($) | May 17, 2021 USD ($) | Apr. 14, 2021 $ / shares | Dec. 12, 2018 | Dec. 11, 2018 | Jul. 10, 2017 USD ($) | Jul. 01, 2017 USD ($) | Oct. 31, 2014 USD ($) | Mar. 31, 2019 USD ($) | Feb. 28, 2005 | Mar. 31, 2024 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2025 USD ($) | Dec. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) | Apr. 14, 2021 $ / shares | Apr. 09, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Upfront Payment | $ 75 | ||||||||||||||||
Ocumension [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Partnership agreement, warrant or rights period | 4 years | ||||||||||||||||
Exchange rate | 0.12853 | ||||||||||||||||
Class of warrant or right, exercise price of warrants or rights (per share) | (per share) | $ 3.07 | $ 23.88 | |||||||||||||||
Collaborative Arrangement, Co-promotion [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative arrangement, increase in royalty payable on net revenue (as a percentage) | 6% | ||||||||||||||||
Collaborative arrangement, royalty payable on net revenue over threshold, percentage | 6% | 2% | 20% | ||||||||||||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75 | $ 75 | |||||||||||||||
Royalty expense | $ 0.9 | $ 0.7 | |||||||||||||||
Reduction in royalty on net revenues up to threshold, third year and thereafter (as a percentage) | 5.20% | ||||||||||||||||
Minimum days to require to revert license in case of breaches of contract | 30 days | ||||||||||||||||
Maximum days to require to revert license in case of breaches of contract | 90 days | ||||||||||||||||
Period of bankruptcy petition proceedings remains undismissed | 30 days | ||||||||||||||||
Possible reversion period | 60 days | ||||||||||||||||
Collaborative Arrangement, Co-promotion [Member] | Accounts Payable [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Accrued royalty expense | 0.9 | $ 0.7 | |||||||||||||||
Eyepoint License Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75 | ||||||||||||||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5 | ||||||||||||||||
Collaborative arrangement, royalty payable on net revenue, including additional threshold (as a percentage) | 8% | ||||||||||||||||
Reduction in royalty on net revenues in excess of threshold, third year and thereafter (as a percentage) | 6.80% | ||||||||||||||||
Additional guaranty payments | $ 25 | 1.9 | |||||||||||||||
Eyepoint License Agreement [Member] | Maximum [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Recoverable amount to offset future royalty payments | $ 15 | ||||||||||||||||
New Collaboration Agreement, 2017 Second Amended [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Royalty future offset | 6.4 | $ 6.5 | |||||||||||||||
Ocumension [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Payment from related party | 10 | ||||||||||||||||
Deferred revenue related party | 0.4 | $ 0.4 | |||||||||||||||
Ocumension [Member] | Milestone One [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Payment from related party | $ 89 | ||||||||||||||||
Forecast [Member] | Eyepoint License Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Additional guaranty payments | $ 7.5 | ||||||||||||||||
Product Rights [Member] | Eyepoint License Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Upfront Payment | $ 75 | ||||||||||||||||
Product Rights [Member] | Forecast [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Additional guaranty payments | 7.5 | ||||||||||||||||
Product Rights [Member] | Forecast [Member] | Eyepoint License Agreement [Member] | |||||||||||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||||||||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 70 | ||||||||||||||||
Additional guaranty payments | $ 7.5 |
Loan Agreements (SLR Investment
Loan Agreements (SLR Investment Corp.) (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||
May 17, 2023 | Dec. 31, 2020 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 06, 2024 | Mar. 24, 2023 | Dec. 31, 2019 | Jan. 05, 2018 | |
Debt Instrument [Line Items] | ||||||||
Gain (loss) on extinguishment of debt | $ (1,100) | |||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Achievement of Milestone [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest Expense | $ 1,300 | |||||||
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 | |||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2018 [Member] | Amendment 7 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 72,500 | |||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 47,500 | $ 45,000 | ||||||
Increase in borrowing capacity | 2,500 | |||||||
Debt instrument, interest rate, stated percentage | 5.15% | |||||||
Interest rate effective percentage | 10.47% | 10.50% | ||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Amendment 7 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 67,500 | |||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Loan Agreement 2019 [Member] | Secured Overnight Financing Rate (SOFR) [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] | Secured Overnight Financing Rate (SOFR) [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] | Amendment 5 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 15,000 | |||||||
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 | |||||||
Gain (loss) on extinguishment of debt | $ 20,000 | |||||||
SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Additional Term Loan [Member] | Amendment 7 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 5,000 | |||||||
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 | |||||||
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 | |||||||
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 | |||||||
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 | |||||||
2019 Exit Fee Agreement [Member] | Secured Overnight Financing Rate (SOFR) [Member] | Milestone 1 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Milestone revenue requirement | $ 75,000 | |||||||
Milestone period requirement | 12 months | |||||||
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 | $ 700 | |||||||
2019 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Milestone 1 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, exit fee | 700 | |||||||
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 | 300 | |||||||
Milestone revenue requirement | 95,000 | |||||||
2023 Exit Fee Agreement [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, exit fee | 3,800 | |||||||
2023 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 72,500 | |||||||
Interest rate effective percentage | 1.50% | |||||||
Debt instrument, exit fee agreement, term | 10 years | |||||||
Debt instrument, exit fee | $ 2,400 | |||||||
Milestone revenue requirement | $ 82,500 | |||||||
Milestone period requirement | 12 years | |||||||
2023 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Achievement of Milestone [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | 1,100 | |||||||
2023 Exit Fee Agreement [Member] | SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] | Amendment 1 [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Interest Expense | $ 1,100 |
Loan Agreements (Modification o
Loan Agreements (Modification of Debt) (Narrative) (Details) - SLR Investment Corp. (formerly named Solar Capital Ltd.) [Member] $ in Millions | Mar. 31, 2024 USD ($) |
Loan Agreement 2019 [Member] | Amendment 5 [Member] | |
Debt Instrument [Line Items] | |
Deferred financing costs | $ 2.6 |
Maximum [Member] | Amendment 7 [Member] | |
Debt Instrument [Line Items] | |
Deferred financing costs | $ 0.1 |
Loan Agreements (Extinguishment
Loan Agreements (Extinguishment of Debt) (Narrative) (Details) $ in Millions | May 17, 2023 USD ($) |
Debt Instrument [Line Items] | |
Loss on extinguishment of debt | $ 1.1 |
Earnings (Loss) Per Share (Sche
Earnings (Loss) Per Share (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,609,022 | 12,680,575 |
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) | 5,714,286 | |
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 | 5,714,286 |
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) | 3,239,384 | 1,216,953 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,769,638 | 35,050 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |||||
Aug. 15, 2023 | May 31, 2023 | Mar. 31, 2023 | Oct. 31, 2012 | Mar. 31, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | |
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 | |||||
Stock issuance costs incurred | $ 498,000 | ||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||
Preferred stock, shares issued (in shares) | 0 | 0 | |||||
Proceeds from issuance of preferred stock | 12,000,000 | ||||||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | |||||
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 | |||||
Common Stock, Shares, Issued | 52,374,687 | 52,354,450 | |||||
Common Stock, Shares, Outstanding | 52,374,687 | 52,354,450 | |||||
Preferred Stock, Shares Issued | 0 | 0 | |||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||||
Series A Preferred Stock [Member] | |||||||
Conversion of Stock [Line Items] | |||||||
Issuance of stock (in shares) | 1,000,000 | ||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 300,000 | ||||||
Stock issuance costs incurred | $ 600,000 | ||||||
Proceeds from issuance of preferred stock | $ 40,000,000 | ||||||
Shares repurchased | $ 938,000 | ||||||
Series B Preferred Stock [Member] | Tranche One [Member] | |||||||
Conversion of Stock [Line Items] | |||||||
Issuance of stock (in shares) | 12,000 | ||||||
Proceeds from issuance of preferred stock | $ 12,000,000 | ||||||
Share Price | $ 1,000 | $ 1,000 | |||||
Series B Preferred Stock [Member] | Tranche Two [Member] | |||||||
Conversion of Stock [Line Items] | |||||||
Issuance of stock (in shares) | 67,000 | ||||||
Proceeds from issuance of preferred stock | $ 67,000,000 | ||||||
Share Price | $ 1,000 | ||||||
Common Stock [Member] | |||||||
Conversion of Stock [Line Items] | |||||||
Shares issued in conversion of preferred stock (in shares) | 43,617,114 | ||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 2,000,000 | ||||||
Class of warrant or right, exercise price of warrants or rights (per share) | $ 0.01 |
Stock-Based Compensation (Narra
Stock-Based Compensation (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Aug. 01, 2023 | Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2023 | Feb. 08, 2024 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 | $ 0.01 | |||
Stock-based compensation expense | $ 845 | $ 226 | ||||
Weighted average contractual term | 5 years 8 months 8 days | 5 years 4 months 24 days | ||||
2019 Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 460,106 | 142,511 | 142,511 | |||
2023 Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 182,906 | |||||
Shares of common stock reserved | 3,231,755 | |||||
Percentage of number of shares of common stock that may be issued | 6% | |||||
2024 Equity Inducement Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares of common stock reserved | 800,000 | |||||
Common stock, par value (usd per share) | $ 0.01 | |||||
Directors Option Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 4 years | |||||
Weighted average contractual term | 10 years | |||||
Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 500 | 200 | ||||
Share-based compensation not yet recognized | $ 4,900 | |||||
Weighted average contractual term | 3 years 3 months 7 days | 10 years | ||||
Restricted Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 400 | |||||
Weighted average contractual term | 3 years 4 months 24 days | |||||
Unrecognized share based compensation expense | $ 3,200 | |||||
Employee Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | 100 | 100 | ||||
Vesting period | 4 years | |||||
Performance-Based Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Performance period | 3 years | |||||
Unrecognized share based compensation expense | $ 2,700 | |||||
Weighted average period | 2 years 10 months 24 days | |||||
Minimum [Member] | Performance-Based Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Percentage of award earned based on degree of achievement | 0% | |||||
Maximum [Member] | Restricted Stock [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 100 | |||||
Maximum [Member] | Performance-Based Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Percentage of award earned based on degree of achievement | 100% |
Stock-Based Compensation (Summa
Stock-Based Compensation (Summary of Stock Option Activity (Details) - $ / shares | 3 Months Ended | ||
Mar. 31, 2024 | Mar. 31, 2023 | Dec. 31, 2023 | |
Options | |||
Options outstanding at beginning of period | 3,194,574 | 1,175,339 | |
Grants | 99,500 | 100,402 | |
Forfeitures | (41,565) | (58,788) | |
Exercises | (13,125) | ||
Options outstanding at period end | 3,239,384 | 1,216,953 | |
Options exercisable at period end | 1,117,599 | 867,650 | 993,037 |
Weighted average per share fair value of options granted during the period | $ 2.86 | $ 1.88 | |
Weighted Average Exercise Price ($) | |||
Options outstanding at beginning of period | 7.42 | 19.03 | |
Grants | 4.18 | 2.73 | |
Forfeitures | 4.09 | 11.85 | |
Exercises | 2.82 | ||
Options outstanding at period end | 7.38 | 18.03 | |
Options exercisable at period end | $ 14.89 | $ 23.38 | $ 16.34 |
Stock-Based Compensation (Sum_2
Stock-Based Compensation (Summary of Additional Stock Option Transactions) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2024 | Dec. 31, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | |
Outstanding Stock Options | ||||
Outstanding, shares (in shares) | 3,239,384 | 3,194,574 | 1,216,953 | 1,175,339 |
Outstanding, weighted average exercise price (usd per share) | $ 7.38 | $ 7.42 | $ 18.03 | $ 19.03 |
Outstanding, weighted average remaining contractual term | 8 years 2 months 1 day | 8 years 4 months 6 days | ||
Outstanding, aggregate intrinsic value | $ 1,491 | $ 2,460 | ||
Exercisable Stock Options | ||||
Exercisable, shares (in shares) | 1,117,599 | 993,037 | 867,650 | |
Exercisable, weighted average exercise price (usd per share) | $ 14.89 | $ 16.34 | $ 23.38 | |
Exercisable, weighted average remaining contractual term | 5 years 8 months 8 days | 5 years 4 months 24 days | ||
Exercisable, aggregate intrinsic value | $ 260 | $ 258 | ||
Exercisable and expected to vest | ||||
Outstanding, vested and expected to vest, shares (in shares) | 2,747,507 | 2,887,226 | ||
Outstanding, vested and expected to vest, weighted average exercise price (usd per share) | $ 8.09 | $ 7.84 | ||
Outstanding, vested and expected to vest, weighted average remaining contractual term | 7 years 11 months 1 day | 8 years 2 months 12 days | ||
Outstanding, vested and expected to vest, aggregate intrinsic value | $ 1,222 | $ 2,164 |
Stock-Based Compensation (Sum_3
Stock-Based Compensation (Summary of Restricted Stock Transactions) (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock Options Activity | ||
Beginning of period (in shares) | 625,000 | |
Grants (in shares) | 275,000 | |
End of period (in shares) | 900,000 | |
Weighted Average Grant Date Fair Value ($) | ||
Beginning of period (usd per share) | $ 2.99 | |
Grants (usd per share) | 3.77 | |
Vested restricted stock and RSUs (usd per share) | ||
End of period (usd per share) | $ 3.23 | |
Restricted Stock and Restricted Stock Units [Member] | ||
Stock Options Activity | ||
Beginning of period (in shares) | 1,217,076 | 73,594 |
Grants (in shares) | 223,300 | 632,050 |
Vested (in shares) | (159,256) | (20,468) |
Forfeitures (in shares) | ||
End of period (in shares) | 1,281,120 | 685,176 |
Weighted Average Grant Date Fair Value ($) | ||
Beginning of period (usd per share) | $ 2.35 | $ 4.98 |
Grants (usd per share) | 3.77 | 1.39 |
Vested restricted stock and RSUs (usd per share) | 1.82 | 4.98 |
Forfeitures (usd per share) | ||
End of period (usd per share) | $ 2.66 | $ 1.67 |
Stock-Based Compensation (Sum_4
Stock-Based Compensation (Summary of PSU Activity) (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Stock Options Activity | ||
Beginning of period (in shares) | 625,000 | |
Grants (in shares) | 275,000 | |
End of period (in shares) | 900,000 | |
Weighted Average Grant Date Fair Value ($) | ||
Beginning of period (usd per share) | $ 2.99 | |
Grants (usd per share) | 3.77 | |
Vested restricted stock and RSUs (usd per share) | ||
End of period (usd per share) | $ 3.23 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Dec. 31, 2023 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax benefit | $ 32 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | $ 146,800 | |
Operating loss carryforwards, utilized | 1,100 | |
Operating loss carryforwards, utilized | 1,100 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | $ 106,800 |
Segment Information (Narrative)
Segment Information (Narrative) (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2024 segment customer | Mar. 31, 2023 customer | Dec. 31, 2023 segment | |
Segment Reporting Information [Line Items] | |||
Number of operating segments | 3 | ||
U.S. [Member] | Customer Concentration Risk [Member] | Revenues [Member] | |||
Segment Reporting Information [Line Items] | |||
Number Of Customers | customer | 2 | 2 | |
U.S. [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||
Segment Reporting Information [Line Items] | |||
Number Of Customers | 2 | 2 | |
Large Pharmaceutical Distributors [Member] | U.S. [Member] | Customer Concentration Risk [Member] | Revenues [Member] | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 63% | 56% | |
Large Pharmaceutical Distributors [Member] | U.S. [Member] | Customer Concentration Risk [Member] | Accounts Receivable [Member] | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 70% | 70% | |
Large Pharmaceutical Distributors [Member] | International [Member] | Customer Concentration Risk [Member] | Revenues [Member] | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 53% | 46% |
Segment Information (Summary of
Segment Information (Summary of Operations by Segment) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Segment Reporting Information [Line Items] | ||
Net revenue | $ 23,011 | $ 13,546 |
Cost of goods sold, excluding depreciation and amortization | (3,353) | (2,028) |
Gross profit | 19,658 | 11,518 |
Research, development and medical affairs expenses | 4,361 | 4,164 |
General and administrative expenses | 5,432 | 4,171 |
Sales and marketing expenses | 9,082 | 5,804 |
Depreciation and amortization | 3,085 | 681 |
Total operating expenses | 21,960 | 14,820 |
Loss from operations | (2,302) | (3,302) |
Other income and expenses, net | (3,981) | (1,666) |
Net loss before income taxes | (6,283) | (4,968) |
U.S. [Member] | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 14,552 | 7,582 |
Cost of goods sold, excluding depreciation and amortization | (1,424) | (905) |
Gross profit | 13,128 | 6,677 |
Research, development and medical affairs expenses | 1,300 | 1,162 |
General and administrative expenses | 568 | 1,184 |
Sales and marketing expenses | 6,953 | 4,274 |
Total operating expenses | 8,821 | 6,620 |
Loss from operations | 4,307 | 57 |
International [Member] | ||
Segment Reporting Information [Line Items] | ||
Net revenue | 8,459 | 5,964 |
Cost of goods sold, excluding depreciation and amortization | (1,929) | (1,123) |
Gross profit | 6,530 | 4,841 |
Research, development and medical affairs expenses | 684 | 756 |
General and administrative expenses | 561 | 716 |
Sales and marketing expenses | 1,548 | 1,415 |
Total operating expenses | 2,793 | 2,887 |
Loss from operations | 3,737 | 1,954 |
Operating Cost [Member] | ||
Segment Reporting Information [Line Items] | ||
Research, development and medical affairs expenses | 2,326 | 2,224 |
General and administrative expenses | 3,657 | 2,116 |
Sales and marketing expenses | 434 | 66 |
Total operating expenses | 6,417 | 4,406 |
Loss from operations | (6,417) | (4,406) |
Other Segments [Member] | ||
Segment Reporting Information [Line Items] | ||
Research, development and medical affairs expenses | 51 | 22 |
General and administrative expenses | 646 | 155 |
Sales and marketing expenses | 147 | 49 |
Depreciation and amortization | 3,085 | 681 |
Total operating expenses | 3,929 | 907 |
Loss from operations | (3,929) | (907) |
Other income and expenses, net | $ (3,981) | $ (1,666) |
Other Agreements with Ocumens_2
Other Agreements with Ocumension (Narrative) (Details) - Ocumension [Member] | Apr. 14, 2021 $ / shares shares | Apr. 14, 2021 $ / shares shares | Apr. 09, 2021 |
Related Party Transaction [Line Items] | |||
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 |
Fair Value (Fair Value of Asset
Fair Value (Fair Value of Assets and Liabilities) (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant asset | $ 6 | $ 52 |
Assets measured at fair value | 6 | 52 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrant asset | 6 | 52 |
Assets measured at fair value | $ 6 | $ 52 |