Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 21, 2022 | Jun. 30, 2021 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Current Fiscal Year End Date | --12-31 | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Smaller Reporting Company | true | ||
Emerging Growth Company | false | ||
ICFR Auditor Attestation | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 59,501,651 | ||
Entity common stock, shares outstanding (in shares) | 6,992,654 | ||
Documents Incorporated by Reference | Specified portions of the registrant’s proxy statement with respect to the registrant’s 2022 Annual Meeting of Stockholders, which is to be filed pursuant to Regulation 14A within 120 days after the end of the registrant’s fiscal year ended December 31, 2021, are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Entity Central Index Key | 0001267602 | ||
Amendment Flag | false | ||
Document Fiscal Period Focus | FY | ||
Auditor Firm ID | 248 | ||
Auditor Name | GRANT THORNTON LLP | ||
Auditor Location | Atlanta, Georgia |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 16,510 | $ 11,208 |
Restricted cash | 34 | 34 |
Accounts receivable, net | 19,128 | 17,200 |
Prepaid expenses and other current assets | 3,809 | 3,718 |
Inventory (Note 6) | 2,679 | 2,746 |
Total current assets | 42,160 | 34,906 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | 2,783 | 1,638 |
Right of use assets, net | 1,710 | 720 |
Intangible asset, net | 10,897 | 12,838 |
Deferred tax asset | 137 | 753 |
Warrant asset | 833 | |
TOTAL ASSETS | 58,520 | 50,855 |
CURRENT LIABILITIES: | ||
Accounts payable | 8,706 | 7,461 |
Accrued expenses (note 9) | 3,617 | 3,197 |
Paycheck Protection Program (PPP) loan (Note 12) | 1,481 | |
Finance lease obligations | 269 | 209 |
Total current liabilities | 12,592 | 12,348 |
NON-CURRENT LIABILITIES: | ||
Notes payable (Note 12) | 43,080 | 42,408 |
Other non-current liabilities | 5,453 | 4,077 |
COMMITMENTS AND CONTINGENCIES (Note 13) | ||
STOCKHOLDERS’ DEFICIT: | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 6,935,154 shares issued and outstanding at December 31, 2021 and 5,719,367 shares issued and outstanding at December 31, 2020 (Note 2) | 69 | 57 |
Additional paid-in capital | 377,229 | 365,830 |
Common stock warrants | 370 | |
Accumulated deficit | (397,281) | (392,909) |
Accumulated other comprehensive loss — foreign currency translation adjustments | (1,849) | (553) |
TOTAL STOCKHOLDERS’ DEFICIT | (2,605) | (7,978) |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | 58,520 | 50,855 |
Series A convertible preferred stock | ||
STOCKHOLDERS’ DEFICIT: | ||
Preferred stock, $.01 par value — 10,000,000 shares authorized at December 31, 2021 and 2020: Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at December 31, 2021 and 2020; liquidation preference of $24,000 at December 31, 2021 and 2020 | $ 19,227 | $ 19,227 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 6,935,154 | 5,719,367 |
Common stock, shares outstanding (in shares) | 6,935,154 | 5,719,367 |
Series A convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 1,300,000 | 1,300,000 |
Preferred stock, shares issued (in shares) | 600,000 | 600,000 |
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 |
Preferred stock, liquidation preference | $ 24,000 | $ 24,000 |
Consolidated Statements Of Oper
Consolidated Statements Of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
NET REVENUE | $ 59,029 | $ 50,820 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (7,030) | (6,941) |
GROSS PROFIT | 51,999 | 43,879 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 13,778 | 9,668 |
GENERAL AND ADMINISTRATIVE EXPENSES | 12,774 | 11,652 |
SALES AND MARKETING EXPENSES | 23,069 | 20,384 |
DEPRECIATION AND AMORTIZATION | 2,579 | 2,676 |
OPERATING EXPENSES | 52,200 | 44,380 |
LOSS FROM OPERATIONS | (201) | (501) |
INTEREST EXPENSE AND OTHER | (5,413) | (5,380) |
UNREALIZED FOREIGN CURRENCY GAIN, NET | 416 | 474 |
GAIN ON EXTINGUISHMENT OF DEBT | 1,792 | |
CHANGE IN FAIR VALUE OF WARRANT ASSET | (528) | |
NET LOSS BEFORE TAXES | (3,934) | (5,407) |
(PROVISION) BENEFIT FOR TAXES | (438) | 68 |
NET LOSS | $ (4,372) | $ (5,339) |
NET LOSS PER SHARE — Basic and diluted (Note 2) | $ (0.66) | $ (1.04) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and Diluted | 6,595,237 | 5,117,656 |
Product [Member] | ||
NET REVENUE | $ 47,981 | $ 50,820 |
License [Member] | ||
NET REVENUE | $ 11,048 |
Consolidated Statements Of Comp
Consolidated Statements Of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Consolidated Statements Of Comprehensive Loss [Abstract] | ||
NET LOSS | $ (4,372) | $ (5,339) |
OTHER COMPREHENSIVE INCOME (LOSS) | ||
Foreign currency translation adjustments | (1,296) | 540 |
TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | (1,296) | 540 |
COMPREHENSIVE LOSS | $ (5,668) | $ (4,799) |
Consolidated Statements Of Chan
Consolidated Statements Of Changes in Shareholders' Deficit - USD ($) $ in Thousands | Common Stock | Preferred StockSeries A convertible preferred stock | Preferred StockSeries C convertible preferred stock | Additional Paid-In Capital | Common Stock Warrants | Accumulated Deficit | Accumulated Other Comprehensive Loss | Total |
Beginning balance (in shares) at Dec. 31, 2019 | 4,965,949 | 600,000 | 10,150 | |||||
Beginning balance at Dec. 31, 2019 | $ 50 | $ 19,227 | $ 11,117 | $ 350,117 | $ 3,707 | $ (387,570) | $ (1,093) | $ (4,445) |
Issuance of common stock, net of issuance costs (in shares) | 76,745 | |||||||
Issuance of common stock, net of issuance costs | 49 | $ 49 | ||||||
Stock option exercises (in shares) | 0 | |||||||
Preferred stock conversion (in shares) | 676,673 | (10,150) | ||||||
Preferred stock conversion | $ 7 | $ (11,117) | 11,110 | |||||
Stock-based compensation expense | 1,331 | $ 1,331 | ||||||
Expiration of common warrants | 3,337 | (3,337) | ||||||
Other | (114) | (114) | ||||||
Net loss | (5,339) | (5,339) | ||||||
Foreign currency translation adjustments | 540 | 540 | ||||||
Ending balance (in shares) at Dec. 31, 2020 | 5,719,367 | 600,000 | ||||||
Ending balance at Dec. 31, 2020 | $ 57 | $ 19,227 | 365,830 | 370 | (392,909) | (553) | (7,978) | |
Issuance of common stock, net of issuance costs (in shares) | 1,223,323 | |||||||
Issuance of common stock, net of issuance costs | $ 12 | 9,990 | $ 10,002 | |||||
Stock option exercises (in shares) | 6,397 | 6,397 | ||||||
Stock option exercises | 42 | $ 42 | ||||||
Stock-based compensation expense | 997 | 997 | ||||||
Forfeitures of restricted stock (in shares) | (13,933) | |||||||
Expiration of common warrants | 370 | $ (370) | ||||||
Net loss | (4,372) | (4,372) | ||||||
Foreign currency translation adjustments | (1,296) | (1,296) | ||||||
Ending balance (in shares) at Dec. 31, 2021 | 6,935,154 | 600,000 | ||||||
Ending balance at Dec. 31, 2021 | $ 69 | $ 19,227 | $ 377,229 | $ (397,281) | $ (1,849) | $ (2,605) |
Consolidated Statements Of Cash
Consolidated Statements Of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (4,372,000) | $ (5,339,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,579,000 | 2,676,000 |
Non-cash consideration received as revenue | (973,000) | |
Unrealized foreign currency transaction gain | (416,000) | (474,000) |
Amortization of debt discount and deferred financing costs | 964,000 | 972,000 |
Deferred tax expense | 610,000 | 31,000 |
Stock-based compensation expense | 997,000 | 1,331,000 |
Gain on extinguishment of debt | (1,792,000) | |
Change in fair value of warrant asset | 528,000 | |
Changes in assets and liabilities: | ||
Accounts receivable | (2,206,000) | 2,631,000 |
Prepaid expenses and other current assets | (404,000) | (683,000) |
Inventory | (19,000) | (1,259,000) |
Accounts payable | 1,485,000 | 106,000 |
Accrued expenses and other current liabilities | 540,000 | (1,664,000) |
Other long-term liabilities | (745,000) | (521,000) |
Net cash used in operating activities | (3,224,000) | (2,193,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (621,000) | (620,000) |
Net cash used in investing activities | (621,000) | (620,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from sale of common stock | 10,084,000 | 49,000 |
Common stock issuance costs | (82,000) | |
Proceeds from exercise of stock options | 42,000 | |
Issuance of debt | 4,278,000 | |
Payment of debt costs | (19,000) | |
Payments on finance lease obligations | (221,000) | (426,000) |
Net cash provided by financing activities | 9,823,000 | 3,882,000 |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (676,000) | 714,000 |
NET INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 5,302,000 | 1,783,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period | 11,242,000 | 9,459,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of year | 16,544,000 | 11,242,000 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 4,302,000 | 3,927,000 |
Cash paid for income taxes | 112,000 | 110,000 |
Supplemental schedule of non-cash investing and financing activities: | ||
Property and equipment acquired under finance leases | 0 | 953,000 |
Property and equipment acquired under operating leases | 1,255,000 | |
Note payable end of term payment accrued but unpaid | $ 2,125,000 | $ 2,125,000 |
Nature Of Operations
Nature Of Operations | 12 Months Ended |
Dec. 31, 2021 | |
Nature Of Operations [Abstract] | |
Nature Of Operations | 1. NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware. The Company presently focuses on diseases affecting the retina, because the Company believes these diseases are not well treated with current therapies and affect millions of people globally. The Company’s only product is ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization and reimbursement in 24 countries for the treatment of diabetic macular edema (DME). 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 five countries for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment (NIU-PS). The Company markets ILUVIEN directly in the U.S., Germany, the U.K., Portugal and Ireland. In addition, the Company has entered into various agreements under which distributors are providing or will provide regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, France, Italy, Luxembourg, the Netherlands, Spain, Australia, New Zealand and several countries in the Middle East. In addition, the Company has granted an exclusive license to Ocumension Therapeutics for the development and commercialization of the Company’s 0.19mg fluocinolone acetonide intravitreal injection in China, East Asia and the Western Pacific. As of December 31, 2021, the Company has recognized sales of ILUVIEN to its international distributors in the Middle East, Austria, Belgium, Czech Republic, France, Italy, Luxembourg, Spain and the Netherlands. Effects of the COVID-19 PandemicThe public health crisis caused by the COVID-19 pandemic and the measures being taken by governments, businesses, and the public at large to limit the COVID-19 pandemic’s spread have had, and the Company expects will continue to have to some degree, certain negative effects on, and present certain risks to, the Company’s business. These limitations and other effects of the COVID-19 pandemic have had an adverse impact on the Company’s revenues beginning late in the first quarter of 2020 and continuing through the fourth quarter of 2021. These factors may continue to adversely impact the Company’s revenue, and the extent and duration of that impact is uncertain, particularly in light of the emergence of COVID-19 variants that may increase the transmissibility of the coronavirus or be more deadly, or both. Depending on the duration of these limitations and the severity and duration of other effects of the COVID-19 pandemic, the Company’s liquidity and financial condition may be adversely affected in the future as well. This uncertainty could have an impact in future periods on certain estimates used in the preparation of the Company’s quarterly financial results, including impairment of intangible assets, the income tax provision and realizability of certain receivables. Should the pandemic intensify, the impact on the Company’s operations could have an adverse effect on the Company’s revenue, financial condition and cash flows.In response to the COVID-19 pandemic, the Company has implemented measures to mitigate the impact of the pandemic on its financial position and operations. These measures include the following:•The Company is continuing to monitor the effects of the SARS-CoV-2 variants and to increase its engagement with its customers to mitigate any anticipated loss of revenue in those markets that may be affected.•The Company is investing in e-marketing and in enhancing its capabilities to conduct meetings virtually as well as in person. |
Summary Of Significant Accounti
Summary Of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Summary Of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESBasis of PresentationThe consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements and accompanying notes. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Furthermore, when testing assets for impairment in future periods, if management uses different assumptions or if different conditions occur, impairment charges may result. Use of Estimates in Financial Statements The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates. Principles of Consolidation The consolidated financial statements include the accounts of Alimera Sciences, Inc. and its wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation. Cash, Cash Equivalents and Restricted Cash Cash equivalents include highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash, cash equivalents and restricted cash held at financial institutions are in excess of federally insured limits. Cash, cash equivalents and restricted cash were $16,544,000 and $11,242,000 as of December 31, 2021 and 2020, respectively, with approximately 46% and 39% of these balances, respectively, held in U.S.-based financial institutions. Revenue See Note 3 for expanded disclosures regarding the Company’s revenues and how the Company accounts for revenue. Accounts Receivable and Allowance for Doubtful Accounts 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 doubtful accounts that reflects management’s best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. A provision for doubtful accounts is charged to operations when management determines the accounts may become uncollectable. 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 December 31, 2021 and 2020, the Company had no reserve for doubtful accounts. During the twelve months ended December 31, 2021, the Company wrote off less than $10,000 for doubtful accounts. During the twelve months ended December 31, 2020, there were no write-offs for doubtful accounts. 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. Intangible Assets The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The Company estimated the useful life of its intangible asset at approximately thirteen years (see Note 8). Warrant Asset Based on the terms of the Company’s warrant agreement with Ocumension Therapeutics, the Company has the right to exercise the warrants at its option and classifies it as a non-current asset. The Company recognizes the warrants at fair value and includes any changes in value on the Company’s statement of operations (see Note 11). Property and Equipment Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture, fixtures and manufacturing equipment, five years; automobiles, three years or the related lease life; software and information technology hardware, three years; and office equipment and leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease life. Impairment Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. The Company recorded no impairment during the years ended December 31, 2021 and 2020. Income Taxes The Company provides for income taxes based on pretax income and applicable tax rates available in the various jurisdictions in which it operates. Significant judgment is required in determining the provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount of future tax benefit that is more likely than not to be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company recognizes both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses were $4,607,000 and $1,295,000 for 2021 and 2020, respectively. Stock-Based Compensation The Company has stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock, restricted stock units (RSUs) and stock options. The fair values of restricted stock, RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over a service period, net of estimated forfeitures. Compensation expense is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 718, Compensation — Stock Compensation (ASC 718). The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model. Additionally, the Company sponsors an employee stock purchase plan (ESPP) under which U.S.-based employees may elect payroll withholdings to fund purchases of the Company’s stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company’s common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans. Fair Value of Financial Instruments 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 Company uses the Black-Scholes option 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 of options granted. Foreign Currency Translation The U.S. dollar is the functional currency of Alimera Sciences, Inc. The Euro is the functional currency for the Company’s subsidiaries operating outside of the U.S. The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using applicable exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in accumulated other comprehensive loss and is the only adjustment recognized in accumulated other comprehensive loss. The Company’s foreign currency assets and liabilities are remeasured into U.S. dollars at end-of-period exchange rates, except for nonmonetary balance sheet accounts, which are remeasured at historical exchange rates. Revenue and expenses are remeasured at average exchange rates in effect during each period, except for those expenses related to the non-monetary balance sheet amounts, which are remeasured at historical exchange rates. Gains or losses from foreign currency remeasurement are included in income. Equity is translated at historical rates and the resulting cumulative translation adjustments are included as a component of accumulated other comprehensive income. Earnings Per Share (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. However, the Company’s preferred stockholders are not contractually obligated to share in losses. Basic EPS is computed by dividing net (loss) income available to stockholders by the weighted average number shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Years Ended December 31, 2021 2020Series A convertible preferred stock 601,504 601,504Common stock warrants — 30,582Stock options 1,075,795 939,379Total 1,677,299 1,571,465 Reporting Segments See Note 19 for expanded disclosures regarding the Company’s reporting segments and how the Company’s Chief Executive Officer (CEO), who is the chief operating decision maker (CODM), reviews its segments. Adoption of New Accounting Standard In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for Income Taxes. The standard eliminates the need for an organization to analyze whether the following apply in a given period: (1) exception to the incremental approach for intra-period tax allocation; (2) exceptions to accounting for basis differences when there are ownership changes in foreign investments; and (3) exceptions in interim period income tax accounting for year-to-date losses that exceed anticipated losses. The ASU also is designed to improve financial statement preparers’ application of income tax-related guidance and simplify GAAP for (1) franchise taxes that are partially based on income, (2) transactions with a government that result in a step-up in the tax basis of goodwill, (3) separate financial statements of legal entities that are not subject to tax and (4) enacted changes in tax laws in interim periods. The standard became effective for the Company on January 1, 2021. The adoption of this guidance did not have a material impact on the Company’s financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The standard requires entities to provide expanded disclosures about the terms and features of convertible instruments and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and contracts on an entity’s own equity. The standard became effective for the Company on January 1, 2022. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (ASC 326): Measurement of Credit Losses on Financial Instruments. This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard becomes effective for the Company on January 1, 2023. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (ASC 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard is available until December 31, 2022. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805) – Accounting for Contract Assets and Contract Liabilities from Contracts with Customers. The amendments in this ASU require that an acquirer recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. The amendments in this ASU are effective for fiscal years beginning after December 15, 2022 with early adoption permitted. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2021 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 3. REVENUE RECOGNITION Overview The Company recognizes revenue when a customer obtains control of the related good or service. The amount recognized reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers, the Company performs the following steps as outlined in the guidance: (1) identify the contract with the customer, (2) identify the performance obligations within the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when the entity satisfies a performance obligation. At the inception of a contract, the contract is evaluated to determine if it falls within the scope of ASC 606, followed by the Company’s assessment of the goods or services promised within each contract, assessment of whether the promised good or service is distinct and determination of the performance obligations. The Company then recognizes revenue based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations. Net Product Sales The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. With respect to the Company’s international contracts with third party distributors, certain contracts have elements of variable consideration, and management reviews those contracts on a regular basis and makes estimates of revenue based on historical ordering patterns and known market events and data. The amount of variable consideration included in net sales in each period could vary depending on the terms of these contracts and the probability of reversal in future periods. Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may, at its option, either refund the sales price paid by the Customer by issuing a credit or exchanging the returned product for replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. The estimation process for product returns involves, in each case, several interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal. License Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable up-front license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. The Company recognizes revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations. The Company will recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606. For those milestone payments which are contingent on the occurrence of particular future events, the Company determines that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the expected value method. As such, the Company assesses each milestone to determine the probability of and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, the Company will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event. Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the Company offers extended payment terms or payment term discounts to certain customers. Amounts are recorded as accounts receivable when the Company's right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services within one year or less of receiving those products or services. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 4. LEASES The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right of use assets and accounts for these, as applicable, at inception of the contract. Upon adoption of ASC 842, the Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right of use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component. Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has determined it is not reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these 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 December 31, 2021 and December 31, 2020 for the Company’s operating leases is as follows: December 31, 2021 2020 (In thousands)NON-CURRENT ASSETS: Right of use assets, net$ 1,710 $ 720Total lease assets$ 1,710 $ 720 CURRENT LIABILITIES: Accrued expenses (Note 9)$ 220 $ 405NON-CURRENT LIABILITIES: Other non-current liabilities 2,735 438Total lease liabilities$ 2,955 $ 843 The Company’s operating lease cost for the year ended December 31, 2021 was $512,000 and is included in general and administrative expenses in its consolidated statements of operations. As of December 31, 2021, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31(In thousands)2022$ 2752023 7222024 6932025 4742026 488Thereafter 1,555Total 4,207Less amount representing interest (1,252)Present value of minimum lease payments 2,955Less current portion (220)Non-current portion$ 2,735 Cash paid for operating leases was $515,000 during the year ended December 31, 2021. The Company obtained right of use assets of approximately $1,255,000 in exchange for operating leases for the year ended December 31, 2021. As of December 31, 2021, the weighted average remaining lease terms of the Company’s operating leases was 7.0 years. The weighted average discount rate used to determine the lease liabilities was 9.5%. When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company’s leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and apply the rates to a portfolio of leases with similar underlying assets and terms. Upon adoption of the new lease standard, discount rates used for existing leases were established. Finance Leases The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. The property and equipment is capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of December 31, 2021 and December 31, 2020 for the Company’s finance leases is as follows: December 31, 2021 2020 (In thousands)NON-CURRENT ASSETS: Property and equipment, net$ 392 $ 810Total lease assets$ 392 $ 810 CURRENT LIABILITIES: Finance lease obligations$ 269 $ 209NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 225 514Total lease liabilities$ 494 $ 723 Depreciation expense associated with property and equipment under finance leases was approximately $396,000 and $404,000 for the years ended December 31, 2021 and 2020, respectively. Interest expense associated with finance leases was $58,000 and $51,000 for the years ended December 31, 2021 and 2020, respectively. As of December 31, 2021, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows: Years Ending December 31(In thousands)2022 3762023 236Total 612Less amount representing interest (118)Present value of minimum lease payments 494Less current portion (269)Non-current portion$ 225 Cash paid for finance leases was $368,000 during the year ended December 31, 2021. No property and equipment was obtained during the year ended December 31, 2021 in exchange for finance leases. As of December 31, 2021, the weighted average remaining lease terms of the Company’s financing leases was 1.1 years. The weighted average discount rate used to determine the financing lease liabilities was 9.4%. When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company’s leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms. |
Going Concern
Going Concern | 12 Months Ended |
Dec. 31, 2021 | |
Going Concern [Abstract] | |
Going Concern | 5. GOING CONCERN The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $397,281,000 from the Company’s inception through December 31, 2021. As of December 31, 2021, the Company had approximately $16,510,000 in cash and cash equivalents. The Company’s ability to achieve profitability and positive cash flow depends on its ability to increase revenue and contain its expenses. Further, the Company must maintain compliance with the debt covenants of its $45,000,000 Loan and Security Agreement dated December 31, 2019 with SLR and certain other lenders (the 2019 Loan Agreement). (See Note 12.) In management’s opinion, the uncertainty regarding future revenues raises substantial doubt about the Company’s ability to continue as a going concern without access to additional debt and/or equity financing, over the course of the next twelve months. The Company’s operations and thus its net product revenues have continued to be adversely affected by the COVID-19 pandemic. During each of the six-month periods ended September 30, 2021 and December 31, 2021, the Company did not generate sufficient revenue to meet the trailing six-month revenue covenant included in the 2019 Loan Agreement (the Revenue Covenant). For each such six-month period, the lenders provided a consent that permitted the Company not to maintain the Revenue Covenant as of September 30, 2021 and December 31, 2021, respectively, and waived any event of default that may have occurred or may have been deemed to have occurred. The Company expects to comply with the Revenue Covenant through one year after these financial statements are issued. However, if the Company were unable to comply with the Revenue Covenant at any time over the course of the next year, the lenders have the right to accelerate the maturity of the loan which would raise substantial doubt about the Company’s ability to continue as a going concern without access to alternative debt and/or equity financing, over the course of the next twelve months. To meet the Company’s future working capital needs, the Company may need to raise additional debt and/or equity financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and has implemented a plan to control its expenses to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity, contain expenses, or increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2021 | |
Inventory [Abstract] | |
Inventory | 6. INVENTORY Inventory consisted of the following: December 31, 2021 2020 (In thousands)Component parts (1)$ 200 $ 623Work-in-process (2) 1,416 1,221Finished goods 1,063 902Total inventory$ 2,679 $ 2,746 (1)Component parts inventory consisted of manufactured components of the ILUVIEN applicator. (2)Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property And Equipment
Property And Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property And Equipment [Abstract] | |
Property And Equipment | 7. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: December 31, 2021 2020 (In thousands)Furniture and fixtures$ 226 $ 392Office equipment 461 547Finance leases 974 1,117Software 1,236 1,308Leasehold improvements 1,380 486Manufacturing equipment 1,936 1,735Total property and equipment 6,213 5,585Less accumulated depreciation and amortization (3,430) (3,947)Property and equipment — net$ 2,783 $ 1,638 Depreciation and amortization expense associated with property and equipment totaled $639,000 and $730,000 for the years ended December 31, 2021 and 2020, respectively. |
Intangible Asset
Intangible Asset | 12 Months Ended |
Dec. 31, 2021 | |
Intangible Asset [Abstract] | |
Intangible Asset | 8. INTANGIBLE ASSET As a result of the U.S. Food and Drug Administration’s (FDA) approval of ILUVIEN in September 2014, the Company was required to pay in October 2014 a milestone payment of $25,000,000 (the EyePoint Milestone Payment) to EyePoint Pharmaceuticals US, Inc. (EyePoint), formerly known as pSivida US, Inc. (see Note 10). The gross carrying amount of the intangible asset is $25,000,000, which is being amortized over approximately 13 years from the acquisition date. The net book value of the intangible asset was $10,897,000 and $12,838,000 as of December 31, 2021 and 2020, respectively, and amortization expense was $1,940,000 and $1,946,000 for the years ended December 31, 2021 and 2020, respectively. The estimated remaining amortization as of December 31, 2021 is as follows (in thousands): Years Ending December 31 2022$ 1,9402023 1,9402024 1,9462025 1,9402026 1,940Thereafter 1,191Total$ 10,897 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 9. ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2021 2020 (In thousands)Accrued clinical investigator expenses$ — $ 25Accrued compensation expenses 2,182 1,372Accrued rebate and other revenue reserves 658 1,116Accrued lease liabilities (note 4) 220 405Other accrued expenses 557 279Total accrued expenses$ 3,617 $ 3,197 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
License Agreements [Abstract] | |
License Agreements | 10. LICENSE AGREEMENTS EyePoint Agreement 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 a number of times (as amended, the EyePoint Agreement). The EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. Second Amended and Restated Collaboration Agreement 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. Before entering into the New Collaboration Agreement, the Company held the worldwide license from EyePoint for the use of EyePoint’s proprietary insert technology for the treatment of all ocular diseases other than uveitis. 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 $75,000,000 in any year. During 2021 and 2020, the Company recognized approximately $2,949,000 and $2,064,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. As of December 31, 2021, approximately $719,000 of this royalty expense was included in the Company’s accounts payable. 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. (The Company’s future rights to recover these amounts from EyePoint are referred to as the Future Offset.) Following the signing of the New Collaboration Agreement, the Company retained a right to recover up to $15,000,000 of the Future Offset. Due to the uncertainty of future net profits, the Company has fully reserved the Future Offset in the accompanying consolidated financial statements. In March 2019, pursuant to the New Collaboration Agreement, the Company forgave $5,000,000 of the Future Offset in connection with the approval of ILUVIEN for NIU-PS in the U.K. As of December 31, 2021, the balance of the Future Offset was approximately $7,419,000. The Company will be able to recover the balance of the Future Offset as a reduction of future royalties that would otherwise be owed to EyePoint as follows: From December 12, 2018 through December 12, 2020, the royalty was reduced from 6% to 4%; and Beginning December 13, 2020, the royalty was reduced from 6% to 5.2% for net revenues and other related consideration up to $75,000,000 annually and from 8% to 6.8% for net revenues and other related consideration in excess of $75,000,000 on an annual basis. Possible Reversion of the Company’s License Rights to EyePoint 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. On December 17, 2020, EyePoint and its parent, EyePoint Pharmaceuticals, Inc., entered into a royalty purchase agreement (the SWK Agreement) with SWK Funding, LLC (SWK). In its Current Report on Form 8-K filed on December 18, 2020, EyePoint Pharmaceuticals, Inc. stated that pursuant to the SWK Agreement, EyePoint Pharmaceuticals, Inc. sold its interest in royalties that the Company is obligated to pay EyePoint under the New Collaboration Agreement. EyePoint Pharmaceuticals, Inc. reported that it had received a one-time $16.5 million payment from SWK and, in return, SWK became entitled to receive future royalties that the Company is obligated to pay to EyePoint under the New Collaboration Agreement. The Company was not a party to the SWK Agreement. Ocumension License Agreement On April 14, 2021, the Company entered into an exclusive license agreement (the License Agreement) with Ocumension (Hong Kong) Limited (Ocumension HK), a wholly owned subsidiary of Ocumension Therapeutics, for the development and commercialization under Ocumension HK’s own brand name(s), either directly or through its affiliates or approved third-party sublicensees, of the Company’s 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 Company received a nonrefundable upfront payment of $10,000,000 from Ocumension HK and may in the future receive additional sales-based milestone payments totaling up to $89,000,000 upon the achievement by Ocumension HK of certain specified sales milestones during the term of the License Agreement. The Company’s receipt of future milestone payments depends upon whether Ocumension HK is able to successfully complete product development and commercialization in the Territory, which requires, among other things, obtaining necessary regulatory approvals and appropriate reimbursement pricing in the various countries and jurisdictions in the Territory, a process that may take several years. In 2021, the Company recognized $11,048,000 in license revenue from the Ocumension transaction (including the value of a warrant subscription agreement, which Alimera received as consideration, for Alimera to purchase 1,000,000 shares of Ocumension Therapeutics during a period of four years), in accordance with ASC 606, Revenue from Contracts with Customers, with the remaining approximate $300,000 in consideration classified as deferred revenue that will be recognized over the remaining term of the license agreement once Ocumension begins to sell products. The term of the License will continue (a) until the 10th anniversary of the latest first commercial sale of the Product in any country or jurisdiction in the Territory or (b) for as long as Ocumension HK is commercializing the Product in any part of the Territory, whichever is later. The term is subject to the Company’s right to partially terminate the Agreement beginning on the 10th anniversary of the effective date with respect to any country or jurisdiction in the Territory in which Ocumension has not achieved at the time of termination first commercial sale and is not continuing to commercialize the Product. Ocumension will purchase Product from the Company at a fixed transfer price without royalty obligation on future sale (other than milestone payments as described above). Ocumension HK is responsible for all costs of development and commercialization in the Territory. When the Company entered into the license agreement, it also entered into a share purchase agreement and a warrant subscription agreement, which are discussed in Note 11. |
Other Agreements With Ocumensio
Other Agreements With Ocumension | 12 Months Ended |
Dec. 31, 2021 | |
Other Agreements With Ocumension [Abstract] | |
Other Agreements With Ocumension | 11. OTHER AGREEMENTS WITH OCUMENSION Share Purchase Agreement On April 14, 2021, the Company entered into a Share Purchase Agreement with Ocumension Therapeutics, pursuant to which the Company offered and sold to Ocumension 1,144,945 shares of common stock (the Shares), at a purchase price of $8.734044 per Share. The number of Shares sold was equal to 19.9% of the number of shares of common stock outstanding immediately before the closing. The aggregate gross proceeds from the sale of the Shares were $10,000,000. The Company intends to use the net proceeds from the sale of the Shares to continue to commercialize ILUVIEN and for general corporate purposes, which may include working capital, capital expenditures, other clinical trial expenditures, acquisitions of new technologies, products or businesses in ophthalmology, and investments. Pursuant to the Share Purchase Agreement and subject to certain limited exceptions, Ocumension is prohibited from selling, transferring, or otherwise disposing of the Shares for a year following the closing date. Ocumension is entitled to certain purchase rights if the Company elects to offer or sell new securities in either a private or public offering. Warrant Subscription Agreement On April 14, 2021, the Company entered into the warrant agreement with Ocumension Therapeutics pursuant to which Ocumension agreed to issue to the Company 1,000,000 non-transferable warrants granting the Company the right for a period of four years to subscribe to up to an aggregate of 1,000,000 shares of Ocumension stock at the subscription price of HK$23.88 per warrant share (or US$3.07 per warrant share as converted to U.S. Dollars at the exchange rate on April 9, 2021 of 0.12853 U.S. Dollars per HK$), subject to adjustment. (The converted rate is for illustrative purposes only; if the Company exercises the warrants, it will pay the subscription price of HK$23.88 per warrant share in HK$.) The warrants were issued on August 13, 2021, pursuant to the terms of the warrant agreement. The warrants are not and will not be listed on any stock exchange. |
Loan Agreements
Loan Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Loan Agreements [Abstract] | |
Loan Agreements | 12. LOAN AGREEMENTS Loan Agreements with SLR Investment Corp. (formerly Solar Capital Ltd.) On January 5, 2018, the Company entered into a $40,000,000 loan and security agreement with Solar Capital Ltd., as Collateral Agent, and the parties signatory thereto from time to time as Lenders, including Solar Capital Ltd. in its capacity as a Lender (the 2018 Loan Agreement). On December 31, 2019, the Company refinanced the 2018 Loan Agreement by entering into a $45,000,000 loan and security agreement (the 2019 Loan Agreement) with Solar Capital Ltd., as Agent, and the parties signing the Loan Agreement from time to time as Lenders, including Solar Capital Ltd. in its capacity as a Lender (collectively, the Lenders). Under the 2019 Loan Agreement, the Company borrowed $42,500,000 on December 31, 2019 and borrowed the remaining $2,500,000 on February 21, 2020. The two borrowings under the 2019 Loan Agreement totaled $45,000,000 and are referred to as the SLR Loan, given that Solar Capital Ltd. changed its name to SLR Investment Corp. (SLR) in February 2021. The SLR Loan matures on July 1, 2024. The Company used the initial proceeds of the SLR Loan to pay off the outstanding loan under the 2018 Loan Agreement, along with related prepayment, legal and other fees and expenses of approximately $2,300,000, which included $2,200,000 in fees to SLR. Interest on the SLR Loan is payable at the greater of (i) one-month LIBOR or (ii) 1.78%, plus 7.65% per annum. As of December 31, 2021, the SLR Loan’s interest rate is 9.43%. The SLR Loan provides for interest only payments until January 1, 2023. If the Company meets certain revenue thresholds and no event of default shall have occurred and is continuing, the Company can extend the interest only period an additional six months, ending on June 30, 2023, followed by one year of monthly payments of principal and interest. 2018 Exit Fee Agreement Notwithstanding the repayment of the outstanding loan under the 2018 Loan Agreement with part of the SLR Loan, the Company remains obligated to pay additional fees under the Exit Fee Agreement (2018 Exit Fee Agreement) dated as of January 5, 2018 by and among the Company, SLR, as Agent, and the Lenders. The 2018 Exit Fee Agreement survived the termination of the 2018 Loan Agreement upon the repayment of the outstanding loan under the 2018 Loan Agreement and has a term of 10 years. The Company is obligated to pay up to, but no more than, $2,000,000 in fees under the 2018 Exit Fee Agreement. Specifically, the Company is obligated to pay an exit fee of $2,000,000 on a “change in control” (as defined in the 2018 Exit Fee Agreement). To the extent that the Company has not already paid the $2,000,000 fee, the Company is also obligated to pay a fee of $1,000,000 on achieving each of the following milestones: first, if the Company achieves revenues of $80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and second, if the Company achieves revenues of $100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner. 2019 Exit Fee Agreement The Company is also obligated to pay additional fees under the Exit Fee Agreement dated as of December 31, 2019 by and among the Company, SLR as Agent, and the Lenders (2019 Exit Fee Agreement). The 2019 Exit Fee Agreement will survive the termination of the 2019 Loan Agreement and has a term of 10 years. The Company will be obligated to pay a $675,000 exit fee upon the occurrence of an exit event, which generally means a change in control, as defined in the 2019 Exit Fee Agreement. First Amendment to 2019 Loan Agreement On May 1, 2020, the Company entered into a First Amendment (the First Amendment) to the 2019 Loan Agreement. The First Amendment also included revised covenants that applied to the Company’s financial performance during 2020, all of which were met. The First Amendment, among other things, required that a revenue covenant be measured at March 31, 2021 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of the Company’s projected revenues in accordance with a plan the Company submitted to Agent in February 2021, and with such plan to be approved by the Company’s board of directors (the Board) and SLR in its sole discretion. Second Amendment to 2019 Loan Agreement On March 30, 2021, the Company entered into a Second Amendment (the Second Amendment) to the 2019 Loan Agreement. The Second Amendment, among other things: (a)reflected Agent’s consent to the Company’s delivery of Board-approved annual financial projections for 2021 by April 1, 2021 (which the Company delivered in a timely manner); (b)specified the minimum revenue amount, calculated on a trailing six-month basis and tested at the end of each calendar quarter in 2021, that the Company must achieve for each such period (the Revenue Covenant); (c)required that the Revenue Covenant be tested at March 31, 2022 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of the Company’s projected revenues in accordance with an annual plan submitted by the Company to Agent by January 15 of such year, such plan to be approved by the Board and Agent in its sole discretion; and (d)provided that in future years the Company must deliver to Agent and the Lenders as soon as available after approval thereof by the Board, but no later than the earlier of (x) 15 days after such approval and (y) February 28 of such year, the Company’s annual financial projections for the entire current fiscal year as approved by the Board; provided that any revisions to such projections approved by the Board shall be delivered to Agent and the Lenders no later than seven days after such approval. Third Amendment to 2019 Loan AgreementOn February 22, 2022, the Company entered into a Third Amendment to the 2019 Loan Agreement (the Third Amendment), which, among other things:(a)specified the minimum revenue amount, calculated on a trailing six-month basis and tested at the end of each calendar quarter in 2022, that the Company must achieve for each such period (the Revenue Covenant); (b)consented to the Company maintaining a lower minimum revenue amount under the Revenue Covenant for the trailing six month period ended December 31, 2021 than previously required under the Loan Agreement (and waived any event of default that may have occurred or may be deemed to have occurred as a result of the Company’s lower revenue amount for that period); and (c)required that the Revenue Covenant be tested at March 31, 2023 and at the last day of each quarter thereafter, with the minimum revenue amount equal to a percentage of the Company’s projected revenues in accordance with an annual plan submitted by the Company to Collateral Agent by January 15 of such year, such plan to be thereafter approved by the Company’s board of directors and Collateral Agent in its sole discretion no later than February 28 of such year. The Company expects to comply with the revenue covenant at the next reportable date, which is March 31, 2022, and the remainder of the revenue covenants through one year after these financial statements are issued. Modification of Debt In accordance with the guidance in ASC 470-50, Debt, the Company entered into and accounted for the 2019 Loan Agreement as a modification and capitalized approximately $427,000 of costs as additional deferred financing costs and expensed approximately $76,000 of costs incurred with third parties within the consolidated statements of operations for the year ended December 31, 2019. In connection with entering into this loan, the Company was obligated to pay a $1,800,000 fee upon repayment of the outstanding loan under the 2018 Loan Agreement that was previously accrued and a $400,000 prepayment fee. In accordance with the guidance in ASC 470-50, Debt, the Company entered into and accounted for the First Amendment and the Second Amendment as modifications and expensed, as they were incurred, an insignificant amount of legal costs associated with third parties as costs of modifications. The Company did not capitalize any additional costs associated with either Amendment. Paycheck Protection Program Loan On April 22, 2020, the Company received a $1,778,000 loan (the PPP Loan) under the Paycheck Protection Program established by the U.S. Small Business Administration as part of the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act. The PPP Loan was unsecured and was evidenced by a note in favor of HSBC Bank USA, National Association (HSBC) as the lender. On July 21, 2020, the Company submitted an application to HSBC for forgiveness of the PPP Loan. The PPP Loan was forgiven in its entirety, including interest, on April 16, 2021. As a result of forgiveness, the Company recognized a gain on extinguishment of debt of $1,792,000 during 2021. 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 December 31, 2021 and December 31, 2020. |
Commitments And Contingencies
Commitments And Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments And Contingencies [Abstract] | |
Commitments And Contingencies | 13. COMMITMENTS AND CONTINGENCIES SLR Loan Under the 2019 Loan Agreement (see Note 12), as of December 31, 2021, the Company is obligated to make future minimum principal payments on the SLR Loan, excluding the $2,250,000 fee that will be due upon its repayment in full, as follows: Years Ending December 31(In thousands)2022$ —2023 28,4212024 16,579Total 45,000Less unamortized debt discount and deferred financing costs (1,920)Less current portion —Non-current portion$ 43,080 At each of December 31, 2021 and 2020, the Company had $365,000 of accrued and unpaid interest payable under the 2019 Loan Agreement. Significant Agreements In February 2016, the Company and Alliance Medical Products Inc., a Siegfried Company (Alliance), a third-party manufacturer, amended and restated the parties’ existing agreement for the manufacture of the ILUVIEN implant, the assembly of the ILUVIEN applicator and the packaging of the completed ILUVIEN commercial product. Under the amended and restated Alliance agreement, its term was extended by five years, at which point the agreement became automatically renewable for successive one-year periods unless either party delivers notice of non-renewal to the other party at least 12 months before the end of the term or any renewal term. The Company is responsible for supplying the ILUVIEN applicator and the active pharmaceutical ingredient, and the Company must order at least 80% of the ILUVIEN units required in the U.S., Canada and the EEA from Alliance. In October 2020, the Company entered into a Manufacturing Services Agreement with Cadence, Inc. (the Cadence Agreement), under which Cadence has replaced the prior manufacturer. In 2021, Cadence began manufacturing certain component parts of the ILUVIEN applicator (the components) at its facility near Pittsburgh, Pennsylvania. Under the Cadence Agreement, the Company pays certain per-unit prices based on regularly scheduled shipments of a minimum number of components. The initial term of the Cadence Agreement expires on October 30, 2025. After the expiration of the initial term, the Cadence Agreement will automatically renew for separate but successive one-year terms unless either party provides written notice to the other party that it does not intend to renew the Cadence Agreement at least 24 months before the end of the term. The Cadence Agreement may be terminated by either party under certain circumstances. In January 2020, the Company began entering into agreements with contract research organizations (CROs) and physician clinics in connection with a multicenter, single masked, randomized and controlled trial designed to generate prospective data evaluating ILUVIEN as a baseline therapy in the treatment of DME and demonstrate its advantages over using the current standard of care of repeat anti-VEGF injections (the NEW DAY Study). The NEW DAY Study is planned to enroll 300 treatment-naïve, or almost naïve, DME patients in approximately 42 sites around the U.S. For the years ended December 31, 2021 and 2020, the Company incurred $3,824,000 and $1,291,000, respectively, of expense associated with the NEW DAY Study. As of December 31, 2021, the Company expects to incur approximately an additional $12,744,000 of expense associated with the study through December 31, 2024. Employment Agreements The Company is party to employment agreements with four executives. The agreements generally provide for annual salaries, bonuses and benefits and for the “at-will” employment of such executives. Effective January 1, 2022, the Company is party to four employment agreements with these four executives with annual salaries ranging from $330,000 to $580,000. If one of these employment agreements is terminated by the Company without cause, or by the employee for good reason, as defined in the applicable agreement, the Company will be liable for one year to 18 months of salary and benefits. Certain other employees have general employment contracts that include stipulations regarding confidentiality, Company property, severance in an event of change of control and miscellaneous items. |
Preferred Stock
Preferred Stock | 12 Months Ended |
Dec. 31, 2021 | |
Preferred Stock [Abstract] | |
Preferred Stock | 14. PREFERRED STOCK Series A Convertible Preferred Stock As of December 31, 2021, there were 600,000 shares of Series A Convertible Preferred Stock issued and outstanding. |
Stock Incentive Plans
Stock Incentive Plans | 12 Months Ended |
Dec. 31, 2021 | |
Stock Incentive Plans [Abstract] | |
Stock Incentive Plans | 15. STOCK INCENTIVE PLANS The Company has stock option and stock incentive plans that provide for grants of shares to employees and grants of options to employees and directors to purchase shares of the Company’s common stock at exercise prices generally equal to the fair values of such stock at the dates of grant. Awards that can be granted under these plans include stock options, restricted stock units (RSUs) and restricted stock. The Company also has an employee stock purchase plan (see Note 18). 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 immediately and have a ten-year contractual term. A summary of stock option transactions under the plans are as follows: Years Ended December 31, 2021 2020 Weighted Weighted Average Average Exercise Exercise Options Price Options PriceOptions outstanding at beginning of period 939,379 $ 26.72 871,472 $ 35.46Grants 228,805 5.63 200,081 6.69Forfeitures (85,992) 14.25 (132,174) 54.06Exercises (6,397) 6.59 — —Options outstanding at year end 1,075,795 23.35 939,379 26.72Options exercisable at year end 809,837 28.76 701,725 32.46Weighted average per share fair value of options granted during the year$ 3.65 $ 4.16 The following table provides additional information related to outstanding stock options, fully vested stock options, and stock options expected to vest as of December 31, 2021: Weighted Weighted Average Average Aggregate Exercise Contractual Intrinsic Shares Price Term Value (In thousands)Outstanding 1,075,795 $ 23.35 5.56 years $ 21Exercisable 809,837 28.76 4.57 years 5Outstanding, vested and expected to vest 1,043,347 28.76 5.46 years 19 The Company estimated the fair value of options granted using the Black-Scholes option pricing model. Use of a valuation model requires the Company to make certain assumptions with respect to selected model inputs. Changes in these input variables would affect the amount of expense associated with equity-based compensation. Expected volatility is based on the historical volatility of the Company’s common shares over the expected term of the stock option grant. To estimate the expected term, the Company utilizes the “simplified” method for “plain vanilla” options as discussed within the SEC’s Statement of Accounting Bulletin 107. The Company intends to utilize the simplified method for the foreseeable future until more detailed information about exercise behavior will be more widely available. The risk-free interest rate is based on U.S. Treasury Daily Treasury Yield Curve Rates corresponding to the expected life assumed at the date of grant. Dividend yield is zero as there are no payments of dividends made or expected. The weighted-average assumptions used for option grants were as follows: Years Ended December 31, 2021 2020Risk-free interest rate 0.66% 1.47%Volatility factor 74.47% 69.20%Grant date fair value of common stock options$ 3.65 $ 4.16Weighted-average expected life 6.03 years 6.02 yearsAssumed forfeiture rate 10.00% 10.00% Employee stock-based compensation expense related to stock options recognized in accordance with ASC 718 was as follows: Years Ended December 31, 2021 2020 (In thousands)Sales and marketing$ 199 $ 244Research, development and medical affairs 77 116General and administrative 595 719Total employee stock-based compensation expense related to stock options$ 871 $ 1,079 As of December 31, 2021, there was approximately $1,076,000 of total unrecognized compensation cost related to outstanding stock option awards that will be recognized over a weighted average period of 2.39 years. The total fair value of shares vested during 2021 was approximately $866,000. The total estimated fair value of options granted during the years ended December 31, 2021 and 2020 was $835,000 and $831,000, respectively. The total estimated intrinsic value of options exercised was $23,000 for the year ended December 31, 2021. There were no options exercised for the years ended December 31, 2020. Restricted Stock and Restricted Stock Units A summary of restricted stock and restricted stock units (RSU) transactions under the plans are as follows: Years Ended December 31, 2021 2020 Weighted Weighted Restricted Average Grant Average Grant Stock Date Fair Date Fair & RSUs Value RSUs ValueRestricted stock & RSUs outstanding at beginning of period 30,086 $ 3.12 36,763 $ 13.15Grants of restricted stock & RSUs 55,500 5.73 30,086 3.12Vested shares of restricted stock & RSUs (25,403) 3.12 (36,763) 13.15Forfeitures (13,933) 5.15 — —Restricted stock & RSUs outstanding at year end 46,250 5.65 30,086 3.12 As of December 31, 2021, there was approximately $190,000 of total unrecognized compensation cost related to outstanding restricted stock that will be recognized over a weighted average period of 2.58 years. Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718 was $81,000 and $192,000 for the years ended December 31, 2021, and 2020, respectively. |
Concentrations And Credit Risk
Concentrations And Credit Risk | 12 Months Ended |
Dec. 31, 2021 | |
Concentrations And Credit Risk [Abstract] | |
Concentrations And Credit Risk | 16. CONCENTRATIONS AND CREDIT RISK For the years ended December 31, 2021 and 2020, there were three customers within the U.S. segment. Two of these customers, which are large pharmaceutical distributors, accounted for approximately 55% and 49%, respectively, of the Company’s total consolidated product revenues. These two customers accounted for approximately 68% and 67% of the Company’s consolidated accounts receivable as of December 31, 2021 and 2020, respectively. For the year ended December 31, 2021, one of the Company’s third-party manufacturers of ILUVIEN comprised approximately 12% of the Company’s total purchases, and there were no other vendors that comprised more than 10% of the Company’s total purchases. For the year ended December 31, 2020, one of the Company’s third-party manufacturers of ILUVIEN comprised approximately 14% of the Company’s total purchases, and there were no other vendors that comprised more than 10% of the Company’s total purchases. The Company relies on a single manufacturer for the ILUVIEN intravitreal implant, a single manufacturer for the ILUVIEN applicator and a single active pharmaceutical ingredient manufacturer for ILUVIEN’s active pharmaceutical ingredient. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes [Abstract] | |
Income Taxes | 17. INCOME TAXES On March 27, 2020, the Coronavirus Aid, Relief and Economic Security Act (the CARES Act) was enacted and signed into law. In addition to other provisions, the CARES Act contains modifications to Net Operating Loss (NOL) carryback rules. For each of the twelve months ended December 31, 2021 and 2020, there were no material impacts to the tax provision related to the CARES Act. The components of net loss before taxes are as follows: Years Ended December 31, 2021 2020 (In thousands)United States$ (10,241) $ (5,535)Foreign 6,307 128Loss before provision for income taxes$ (3,934) $ (5,407) In accordance with ASC 740, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against the net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. The provision for income taxes consists of the following components: Years Ended December 31, 2021 2020 (In thousands)Current expense (benefit): Federal$— $ —State — —Foreign (172) (37)Current income tax benefit (172) (37) Deferred expense (benefit): Federal — (1,084)State — (350)Foreign 610 (31) 610 (1,465)Valuation allowance — 1,434Deferred income tax expense (benefit) 610 (31)Total income tax expense (benefit)$ 438 $ (68) The following summarizes activity related to the Company’s valuation allowance: Years Ended December 31, 2021 2020 (In thousands)Valuation allowance at beginning of period$ (38,882) $ (37,448)Increase in valuation allowance (9,973) (1,434)Valuation allowance at end of period$ (48,855) $ (38,882) Worldwide net deferred tax assets and liabilities are as follows: December 31, 2021 2020Deferred tax assets(In thousands)Depreciation and amortization$ 27 $ 69Intangible Assets 7,692 —Other deferred tax assets 829 948NOL carry-forwards 35,335 31,832Equity compensation 3,347 4,902Collaboration agreement receivable reserves 1,762 1,884Valuation allowance (48,855) (38,882)Total deferred tax assets$ 137 $ 753 A reconciliation from the federal statutory rate to the total provision for income taxes is as follows: Years Ended December 31, 2021 2020 Amount Percent Amount Percent (in thousands, except percentages)Federal tax benefit at statutory rate$ (826) 21.0% $ (1,135) 21.0%State tax — net of federal benefit (24) 0.6 (350) 6.5Permanent items and other 240 (6.1) 151 (2.8)Foreign rate differential (1,374) 34.9 52 (1.0)Deferred rate change (215) 5.5 6 (0.1)Tax effect of intellectual property migration (8,547) 217.2 — —Tax credits and true-ups 1,211 (30.7) (226) 4.1Increase in valuation allowance 9,973 (253.5) 1,434 (26.5)Total tax expense (benefit)$ 438 (11.1)% $ (68) 1.2% A rollforward of the Company’s uncertain tax positions is as follows: Years Ended December 31, 2021 2020 (In thousands)Balance of uncertain tax positions at beginning of period$ 65 $ 58Gross increases - tax positions in current period 29 10Gross decreases - tax positions in prior period (6) (3)Balance of uncertain tax positions at end of period$ 88 $ 65 Included in the balance of unrecognized tax benefits as of December 31, 2021 and 2020 are approximately $88,000 and $65,000, respectively, of tax benefits related to research and development tax credits. In accordance with ASC 740-10, such attributes are reduced to the amount that is expected to be recognized in the future. The Company does not accrue interest or penalties, as there is no risk of additional tax liability due to significant NOLs available. The Company does not expect any decreases to the unrecognized tax benefits within the next twelve months due to any lapses in statute of limitations. Tax years from 2018 to 2020 remain subject to examination in California, Georgia, Kentucky, Tennessee, Texas and on the federal level, with the exception of the assessment of NOL carry-forwards available for utilization, which can be examined for all years since 2009. The statute of limitations on these years will close when the NOLs expire or when the statute closes on the years in which the NOLs are utilized. 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. As of December 31, 2021 and 2020, the Company had federal net operating loss (NOL) carry-forwards of approximately $143.2 million and $131.4 million, and state NOL carry-forwards of approximately $106.7 million and $96.2 million, respectively, 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 2038, 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 2021 and 2041. 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 a Section 382 change in ownership occurred in late 2015. As a result of this change in ownership, the Company estimated that approximately $18.6 million of the Company’s federal NOLs and approximately $382,000 of federal tax credits generated prior to the change in ownership will not be utilized in the future. The Company is currently in the process of refining and finalizing these calculations, and upon finalization, will 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. As of December 31, 2021, the Company’s U.K. subsidiary is in a net deferred tax asset position primarily due to the step up in tax basis for intangible assets created by the transfer of intellectual property from the Netherlands to the U.K. Based upon the expected pattern of reversal of deferred taxes, it is not more likely than not that these deferred tax assets will be realized. As such, a full valuation allowance is placed against the net deferred tax assets of the U.K. subsidiary. The Company’s Irish subsidiary has a deferred tax asset for net operating loss carryforwards. The Company expects this net operating loss carryforward to be fully realizable in the future based upon the Company’s control of the transfer pricing arrangements. A valuation allowance is not recorded on the deferred tax assets of the Ireland subsidiary. Deferred tax considerations for all other foreign entities are immaterial to the financial statements. 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. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2021 | |
Employee Benefit Plans [Abstract] | |
Employee Benefit Plans | 18. EMPLOYEE BENEFIT PLANS The Company has a salary deferral 401(k) plan that covers substantially all U.S. employees of the Company. The Company matches participant contributions subject to certain plan limitations. Compensation expense associated with the Company’s matching plan totaled $431,000 and $248,000 for the years ended December 31, 2021 and 2020, respectively. The Company may also make an annual discretionary profit-sharing contribution. No such discretionary contributions were made during the years ended December 31, 2021 and 2020, respectively. In 2010, the Company established an Employee Stock Purchase Plan (the ESPP). Under the ESPP, eligible employees can participate and purchase common stock semi-annually through accumulated payroll deductions. The compensation committee of the Company’s board of directors administers the ESPP. Under the ESPP, eligible employees may purchase stock at 85% of the lower of the fair market value of a share of common stock on the offering date or the exercise date. The ESPP provides for two six-month purchase periods generally starting on the first trading day on or after October 31 and April 30 of each year. Eligible employees may contribute up to 15% of their eligible compensation. A participant may purchase a maximum of 500 shares of common stock per purchase period. The value of the shares purchased in any calendar year may not exceed $25,000. The ESPP was effective upon the completion of the Company’s initial public offering in 2010, at which time a total of 32,961 shares of the Company’s common stock were made available for sale. As of January 1 of each year, the number of available shares is automatically restored to the original level. A total of 22,878 and 13,812 shares of the Company’s common shares were acquired through the ESPP during the years ended December 31, 2021 and 2020, respectively. As such, on January 1, 2022 and 2021 an additional 22,878 and 13,812, respectively, shares became available for future issuance under the ESPP. In accordance with ASC 718-50, the ability to purchase stock at 85% of the lower of the fair market value of a share of common stock on the offering date or the exercise date represents an option. The Company estimates the fair value of such options at the inception of each offering period using the Black-Scholes valuation model. In connection with the ESPP, the Company recorded $45,000 and $60,000 of compensation expense for the years ended December 31, 2021 and 2020, respectively. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2021 | |
Segment Information [Abstract] | |
Segment Information | 19. SEGMENT INFORMATION For the years ended December 31, 2021 and 2020, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 55% and 49% of the Company’s consolidated product revenues for the years ended December 31, 2021 and 2020, respectively. These same two customers within the U.S. segment accounted for approximately 68% and 67% of the Company’s consolidated accounts receivable at December 31, 2021 and 2020, respectively. During the first quarter of 2021, the Chief Executive Officer (CEO), who is the chief operating decision maker (CODM), changed the manner in which the CODM monitors performance, aligns strategies and allocates resources, which resulted in a change in the operating segments. The Company’s operations are now managed as three operating segments: U.S., International and Operating Cost. The Company determined that each of these operating segments represented a reportable segment. Previously, the Company was managed as two operating segments: U.S. and International. In monitoring performance, aligning strategies and allocating resources, our 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, we classify 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 & 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. The following table presents a summary of the Company’s reporting segments for the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 U.S. International Operating Cost Other Consolidated (In thousands)REVENUE: PRODUCT REVENUE, NET$ 26,740 $ 21,241 $ — $ — $ 47,981LICENSE REVENUE — 11,048 — — 11,048NET REVENUE 26,740 32,289 — — 59,029COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (3,298) (3,732) — — (7,030)GROSS PROFIT 23,442 28,557 — — 51,999 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 3,628 4,197 5,850 103 13,778GENERAL AND ADMINISTRATIVE EXPENSES 969 1,322 9,828 655 12,774SALES AND MARKETING EXPENSES 15,348 6,953 529 239 23,069DEPRECIATION AND AMORTIZATION — — — 2,579 2,579OPERATING EXPENSES 19,945 12,472 16,207 3,576 52,200SEGMENT INCOME (LOSS) FROM OPERATIONS 3,497 16,085 (16,207) (3,576) (201)OTHER INCOME AND EXPENSES, NET (3,733) (3,733)NET LOSS BEFORE TAXES $ (3,934) Year Ended December 31, 2020 U.S. International Operating Cost Other Consolidated (In thousands)REVENUE: PRODUCT REVENUE, NET$ 24,809 $ 26,011 $ — $ — $ 50,820LICENSE REVENUE — — — — —NET REVENUE 24,809 26,011 — — 50,820COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (2,858) (4,083) — — (6,941)GROSS PROFIT 21,951 21,928 — — 43,879 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 3,137 2,996 3,386 149 9,668GENERAL AND ADMINISTRATIVE EXPENSES 924 1,481 8,378 869 11,652SALES AND MARKETING EXPENSES 13,784 5,790 489 321 20,384DEPRECIATION AND AMORTIZATION — — — 2,676 2,676OPERATING EXPENSES 17,845 10,267 12,253 4,015 44,380SEGMENT INCOME (LOSS) FROM OPERATIONS 4,106 11,661 (12,253) (4,015) (501)OTHER INCOME AND EXPENSES, NET (4,906) (4,906)NET LOSS BEFORE TAXES $ (5,407) |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value [Abstract] | |
Fair Value | 20. FAIR VALUE The Company applies ASC 820, Fair Value Measurements, in determining the fair value of certain assets and liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various valuation approaches. The hierarchy of those valuation approaches is broken down into three levels based on the reliability of inputs as follows: Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment. Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include: quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, (e.g., interest rates and yield curves observable at commonly quoted intervals or current market) and contractual prices for the underlying financial instrument, as well as other relevant economic measures. Level 3 inputs are unobservable inputs for the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2021 Level 1 Level 2 Level 3 Total (In thousands)Assets: Warrant asset (1)$ — $ 833 $ — $ 833Assets measured at fair value$ — $ 833 $ — $ 833 (1)The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in this value each reporting period are reported in the condensed consolidated statement of operations. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 21. SUBSEQUENT EVENTS Third Amendment to 2019 Loan Agreement On February 22, 2022, the Company entered into the Third Amendment to the 2019 Loan Agreement with SLR. Refer to Note 12, Loan Agreements. |
Summary Of Significant Accoun_2
Summary Of Significant Accounting Policies (Policy) | 12 Months Ended |
Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Basis of Presentation | Basis of PresentationThe consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP). The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements and accompanying notes. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Furthermore, when testing assets for impairment in future periods, if management uses different assumptions or if different conditions occur, impairment charges may result. |
Use of Estimates in Financial Statements | Use of Estimates in Financial Statements The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Alimera Sciences, Inc. and its wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash equivalents include highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash, cash equivalents and restricted cash held at financial institutions are in excess of federally insured limits. Cash, cash equivalents and restricted cash were $16,544,000 and $11,242,000 as of December 31, 2021 and 2020, respectively, with approximately 46% and 39% of these balances, respectively, held in U.S.-based financial institutions. |
Revenue | Revenue See Note 3 for expanded disclosures regarding the Company’s revenues and how the Company accounts for revenue. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts 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 doubtful accounts that reflects management’s best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. A provision for doubtful accounts is charged to operations when management determines the accounts may become uncollectable. 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 December 31, 2021 and 2020, the Company had no reserve for doubtful accounts. During the twelve months ended December 31, 2021, the Company wrote off less than $10,000 for doubtful accounts. During the twelve months ended December 31, 2020, there were no write-offs for doubtful accounts. |
Inventory | 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. |
Intangible Assets | Intangible Assets The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The Company estimated the useful life of its intangible asset at approximately thirteen years (see Note 8). |
Warrant Asset | Warrant Asset Based on the terms of the Company’s warrant agreement with Ocumension Therapeutics, the Company has the right to exercise the warrants at its option and classifies it as a non-current asset. The Company recognizes the warrants at fair value and includes any changes in value on the Company’s statement of operations (see Note 11). |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture, fixtures and manufacturing equipment, five years; automobiles, three years or the related lease life; software and information technology hardware, three years; and office equipment and leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease life. |
Impairment | Impairment Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. The Company recorded no impairment during the years ended December 31, 2021 and 2020. |
Income Taxes | Income Taxes The Company provides for income taxes based on pretax income and applicable tax rates available in the various jurisdictions in which it operates. Significant judgment is required in determining the provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount of future tax benefit that is more likely than not to be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company recognizes both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses were $4,607,000 and $1,295,000 for 2021 and 2020, respectively. |
Stock-Based Compensation | Stock-Based Compensation The Company has stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock, restricted stock units (RSUs) and stock options. The fair values of restricted stock, RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over a service period, net of estimated forfeitures. Compensation expense is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 718, Compensation — Stock Compensation (ASC 718). The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model. Additionally, the Company sponsors an employee stock purchase plan (ESPP) under which U.S.-based employees may elect payroll withholdings to fund purchases of the Company’s stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company’s common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments 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 Company uses the Black-Scholes option 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 of options granted. |
Foreign Currency Translation | Foreign Currency Translation The U.S. dollar is the functional currency of Alimera Sciences, Inc. The Euro is the functional currency for the Company’s subsidiaries operating outside of the U.S. The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using applicable exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in accumulated other comprehensive loss and is the only adjustment recognized in accumulated other comprehensive loss. The Company’s foreign currency assets and liabilities are remeasured into U.S. dollars at end-of-period exchange rates, except for nonmonetary balance sheet accounts, which are remeasured at historical exchange rates. Revenue and expenses are remeasured at average exchange rates in effect during each period, except for those expenses related to the non-monetary balance sheet amounts, which are remeasured at historical exchange rates. Gains or losses from foreign currency remeasurement are included in income. Equity is translated at historical rates and the resulting cumulative translation adjustments are included as a component of accumulated other comprehensive income. |
Earnings Per Share (EPS) | Earnings Per Share (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. However, the Company’s preferred stockholders are not contractually obligated to share in losses. Basic EPS is computed by dividing net (loss) income available to stockholders by the weighted average number shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Years Ended December 31, 2021 2020Series A convertible preferred stock 601,504 601,504Common stock warrants — 30,582Stock options 1,075,795 939,379Total 1,677,299 1,571,465 |
Reporting Segments | Reporting Segments See Note 19 for expanded disclosures regarding the Company’s reporting segments and how the Company’s Chief Executive Officer (CEO), who is the chief operating decision maker (CODM), reviews its segments. |
Adoption Of New Accounting Standard And Accounting Standards Issued But Not Yet Effective | Adoption of New Accounting Standard In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (ASC 740): Simplifying the Accounting for Income Taxes. The standard eliminates the need for an organization to analyze whether the following apply in a given period: (1) exception to the incremental approach for intra-period tax allocation; (2) exceptions to accounting for basis differences when there are ownership changes in foreign investments; and (3) exceptions in interim period income tax accounting for year-to-date losses that exceed anticipated losses. The ASU also is designed to improve financial statement preparers’ application of income tax-related guidance and simplify GAAP for (1) franchise taxes that are partially based on income, (2) transactions with a government that result in a step-up in the tax basis of goodwill, (3) separate financial statements of legal entities that are not subject to tax and (4) enacted changes in tax laws in interim periods. The standard became effective for the Company on January 1, 2021. The adoption of this guidance did not have a material impact on the Company’s financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The standard requires entities to provide expanded disclosures about the terms and features of convertible instruments and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and contracts on an entity’s own equity. The standard became effective for the Company on January 1, 2022. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (ASC 326): Measurement of Credit Losses on Financial Instruments. This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard becomes effective for the Company on January 1, 2023. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (ASC 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting. This standard provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The standard is available until December 31, 2022. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805) – Accounting for Contract Assets and Contract Liabilities from Contracts with Customers. The amendments in this ASU require that an acquirer recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with Topic 606, Revenue from Contracts with Customers. The amendments in this ASU are effective for fiscal years beginning after December 15, 2022 with early adoption permitted. The Company does not anticipate the adoption of this ASU will have a material impact on its financial statements. |
Summary Of Significant Accoun_3
Summary Of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Years Ended December 31, 2021 2020Series A convertible preferred stock 601,504 601,504Common stock warrants — 30,582Stock options 1,075,795 939,379Total 1,677,299 1,571,465 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Summary of Operating Leases Supplemental Balance Sheet Information | December 31, 2021 2020 (In thousands)NON-CURRENT ASSETS: Right of use assets, net$ 1,710 $ 720Total lease assets$ 1,710 $ 720 CURRENT LIABILITIES: Accrued expenses (Note 9)$ 220 $ 405NON-CURRENT LIABILITIES: Other non-current liabilities 2,735 438Total lease liabilities$ 2,955 $ 843 |
Schedule of Future Minimum Operating Lease Payments | Years Ending December 31(In thousands)2022$ 2752023 7222024 6932025 4742026 488Thereafter 1,555Total 4,207Less amount representing interest (1,252)Present value of minimum lease payments 2,955Less current portion (220)Non-current portion$ 2,735 |
Summary of Finance Leases Supplemental Balance Sheet Information | December 31, 2021 2020 (In thousands)NON-CURRENT ASSETS: Property and equipment, net$ 392 $ 810Total lease assets$ 392 $ 810 CURRENT LIABILITIES: Finance lease obligations$ 269 $ 209NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 225 514Total lease liabilities$ 494 $ 723 |
Schedule of Future Minimum Finance Lease Payments | Years Ending December 31(In thousands)2022 3762023 236Total 612Less amount representing interest (118)Present value of minimum lease payments 494Less current portion (269)Non-current portion$ 225 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory [Abstract] | |
Schedule of Inventory | December 31, 2021 2020 (In thousands)Component parts (1)$ 200 $ 623Work-in-process (2) 1,416 1,221Finished goods 1,063 902Total inventory$ 2,679 $ 2,746 (1)Component parts inventory consisted of manufactured components of the ILUVIEN applicator. (2)Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property And Equipment (Tables)
Property And Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property And Equipment [Abstract] | |
Schedule of Property and Equipment | December 31, 2021 2020 (In thousands)Furniture and fixtures$ 226 $ 392Office equipment 461 547Finance leases 974 1,117Software 1,236 1,308Leasehold improvements 1,380 486Manufacturing equipment 1,936 1,735Total property and equipment 6,213 5,585Less accumulated depreciation and amortization (3,430) (3,947)Property and equipment — net$ 2,783 $ 1,638 |
Intangible Asset (Tables)
Intangible Asset (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Intangible Asset [Abstract] | |
Future Amortization | Years Ending December 31 2022$ 1,9402023 1,9402024 1,9462025 1,9402026 1,940Thereafter 1,191Total$ 10,897 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses [Abstract] | |
Summary of Accrued Expenses | December 31, 2021 2020 (In thousands)Accrued clinical investigator expenses$ — $ 25Accrued compensation expenses 2,182 1,372Accrued rebate and other revenue reserves 658 1,116Accrued lease liabilities (note 4) 220 405Other accrued expenses 557 279Total accrued expenses$ 3,617 $ 3,197 |
Commitments And Contingencies (
Commitments And Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
2019 Solar Loan Agreement [Member] | |
Debt Instrument [Line Items] | |
Schedule of Future Minimum Principal Payments Under Note Payable | Years Ending December 31(In thousands)2022$ —2023 28,4212024 16,579Total 45,000Less unamortized debt discount and deferred financing costs (1,920)Less current portion —Non-current portion$ 43,080 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock Incentive Plans [Abstract] | |
Summary of Stock Option Transactions | Years Ended December 31, 2021 2020 Weighted Weighted Average Average Exercise Exercise Options Price Options PriceOptions outstanding at beginning of period 939,379 $ 26.72 871,472 $ 35.46Grants 228,805 5.63 200,081 6.69Forfeitures (85,992) 14.25 (132,174) 54.06Exercises (6,397) 6.59 — —Options outstanding at year end 1,075,795 23.35 939,379 26.72Options exercisable at year end 809,837 28.76 701,725 32.46Weighted average per share fair value of options granted during the year$ 3.65 $ 4.16 |
Summary of Additional Stock Option Transactions | Weighted Weighted Average Average Aggregate Exercise Contractual Intrinsic Shares Price Term Value (In thousands)Outstanding 1,075,795 $ 23.35 5.56 years $ 21Exercisable 809,837 28.76 4.57 years 5Outstanding, vested and expected to vest 1,043,347 28.76 5.46 years 19 |
Weighted-Average Assumptions Used for Option Grants | Years Ended December 31, 2021 2020Risk-free interest rate 0.66% 1.47%Volatility factor 74.47% 69.20%Grant date fair value of common stock options$ 3.65 $ 4.16Weighted-average expected life 6.03 years 6.02 yearsAssumed forfeiture rate 10.00% 10.00% |
Employee Stock-Based Compensation Expense | Years Ended December 31, 2021 2020 (In thousands)Sales and marketing$ 199 $ 244Research, development and medical affairs 77 116General and administrative 595 719Total employee stock-based compensation expense related to stock options$ 871 $ 1,079 |
Summary of Restricted Stock and Restricted Stock Unit Transactions | Years Ended December 31, 2021 2020 Weighted Weighted Restricted Average Grant Average Grant Stock Date Fair Date Fair & RSUs Value RSUs ValueRestricted stock & RSUs outstanding at beginning of period 30,086 $ 3.12 36,763 $ 13.15Grants of restricted stock & RSUs 55,500 5.73 30,086 3.12Vested shares of restricted stock & RSUs (25,403) 3.12 (36,763) 13.15Forfeitures (13,933) 5.15 — —Restricted stock & RSUs outstanding at year end 46,250 5.65 30,086 3.12 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes [Abstract] | |
Components of Net Loss before Taxes | Years Ended December 31, 2021 2020 (In thousands)United States$ (10,241) $ (5,535)Foreign 6,307 128Loss before provision for income taxes$ (3,934) $ (5,407) |
Components of Income Tax Benefit | Years Ended December 31, 2021 2020 (In thousands)Current expense (benefit): Federal$— $ —State — —Foreign (172) (37)Current income tax benefit (172) (37) Deferred expense (benefit): Federal — (1,084)State — (350)Foreign 610 (31) 610 (1,465)Valuation allowance — 1,434Deferred income tax expense (benefit) 610 (31)Total income tax expense (benefit)$ 438 $ (68) |
Summary of Valuation Allowance | Years Ended December 31, 2021 2020 (In thousands)Valuation allowance at beginning of period$ (38,882) $ (37,448)Increase in valuation allowance (9,973) (1,434)Valuation allowance at end of period$ (48,855) $ (38,882) |
Net Deferred Tax Assets (Liabilities) | December 31, 2021 2020Deferred tax assets(In thousands)Depreciation and amortization$ 27 $ 69Intangible Assets 7,692 —Other deferred tax assets 829 948NOL carry-forwards 35,335 31,832Equity compensation 3,347 4,902Collaboration agreement receivable reserves 1,762 1,884Valuation allowance (48,855) (38,882)Total deferred tax assets$ 137 $ 753 |
Reconciliation of Income Tax Benefit to Amount Determined by Applying U.S. Federal Statutory Income Tax Rate | Years Ended December 31, 2021 2020 Amount Percent Amount Percent (in thousands, except percentages)Federal tax benefit at statutory rate$ (826) 21.0% $ (1,135) 21.0%State tax — net of federal benefit (24) 0.6 (350) 6.5Permanent items and other 240 (6.1) 151 (2.8)Foreign rate differential (1,374) 34.9 52 (1.0)Deferred rate change (215) 5.5 6 (0.1)Tax effect of intellectual property migration (8,547) 217.2 — —Tax credits and true-ups 1,211 (30.7) (226) 4.1Increase in valuation allowance 9,973 (253.5) 1,434 (26.5)Total tax expense (benefit)$ 438 (11.1)% $ (68) 1.2% |
Uncertain Tax Positions Rollforward | Years Ended December 31, 2021 2020 (In thousands)Balance of uncertain tax positions at beginning of period$ 65 $ 58Gross increases - tax positions in current period 29 10Gross decreases - tax positions in prior period (6) (3)Balance of uncertain tax positions at end of period$ 88 $ 65 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Information [Abstract] | |
Summary of Operations by Segment | Year Ended December 31, 2021 U.S. International Operating Cost Other Consolidated (In thousands)REVENUE: PRODUCT REVENUE, NET$ 26,740 $ 21,241 $ — $ — $ 47,981LICENSE REVENUE — 11,048 — — 11,048NET REVENUE 26,740 32,289 — — 59,029COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (3,298) (3,732) — — (7,030)GROSS PROFIT 23,442 28,557 — — 51,999 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 3,628 4,197 5,850 103 13,778GENERAL AND ADMINISTRATIVE EXPENSES 969 1,322 9,828 655 12,774SALES AND MARKETING EXPENSES 15,348 6,953 529 239 23,069DEPRECIATION AND AMORTIZATION — — — 2,579 2,579OPERATING EXPENSES 19,945 12,472 16,207 3,576 52,200SEGMENT INCOME (LOSS) FROM OPERATIONS 3,497 16,085 (16,207) (3,576) (201)OTHER INCOME AND EXPENSES, NET (3,733) (3,733)NET LOSS BEFORE TAXES $ (3,934) Year Ended December 31, 2020 U.S. International Operating Cost Other Consolidated (In thousands)REVENUE: PRODUCT REVENUE, NET$ 24,809 $ 26,011 $ — $ — $ 50,820LICENSE REVENUE — — — — —NET REVENUE 24,809 26,011 — — 50,820COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (2,858) (4,083) — — (6,941)GROSS PROFIT 21,951 21,928 — — 43,879 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 3,137 2,996 3,386 149 9,668GENERAL AND ADMINISTRATIVE EXPENSES 924 1,481 8,378 869 11,652SALES AND MARKETING EXPENSES 13,784 5,790 489 321 20,384DEPRECIATION AND AMORTIZATION — — — 2,676 2,676OPERATING EXPENSES 17,845 10,267 12,253 4,015 44,380SEGMENT INCOME (LOSS) FROM OPERATIONS 4,106 11,661 (12,253) (4,015) (501)OTHER INCOME AND EXPENSES, NET (4,906) (4,906)NET LOSS BEFORE TAXES $ (5,407) |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value [Abstract] | |
Fair Value Of Assets And Liabilities | December 31, 2021 Level 1 Level 2 Level 3 Total (In thousands)Assets: Warrant asset (1)$ — $ 833 $ — $ 833Assets measured at fair value$ — $ 833 $ — $ 833 (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] | Dec. 31, 2021country |
Nature Of Operations [Line Items] | |
Number of countries in which product is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies | 24 |
Number of countries in which product is indicated for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye | 17 |
Number of countries authorized for marketing | 17 |
Number of countries with reimbursement approval | 5 |
Summary Of Significant Accoun_4
Summary Of Significant Accounting Policies (Narrative) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash equivalents maturity | 90 days | |
Percentage of cash and cash equivalents in domestic financial institutions | 46.00% | 39.00% |
Reserve for doubtful accounts | $ 0 | $ 0 |
Useful life (in years) | 13 years | |
Impairment | $ 0 | 0 |
Research and development expense | $ 4,607,000 | $ 1,295,000 |
Furniture and fixtures | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Automobiles | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Software Development [Member] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Maximum | ||
Writeoff for doubtful accounts | $ 10,000 |
Summary Of Significant Accoun_5
Summary Of Significant Accounting Policies (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,677,299 | 1,571,465 |
Series A convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 601,504 | 601,504 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 30,582 | |
Stock options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,075,795 | 939,379 |
Revenue Recognition (Narrative)
Revenue Recognition (Narrative) (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Period before expiration date returns are accepted | 3 months |
Period after expiration date returns are accepted | 1 year |
Minimum | |
Customer payment obligation, period | 30 days |
Maximum | |
Customer payment obligation, period | 120 days |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | ||
Other non-current liabilities | $ 2,735,000 | $ 438,000 |
Operating lease cost | 512,000 | |
Cash paid for leases | 515,000 | |
Right-of-use asset obtained in exchange for operating lease liability | $ 1,255,000 | |
Weighted average remaining lease term | 7 years | |
Weighted average discount rate, leases | 9.50% | |
Depreciation expense property and equipment under finance leases | $ 396,000 | 404,000 |
Finance lease interest expense | 58,000 | 51,000 |
Cash paid for finance leases | 368,000 | |
Property and equipment acquired under finance leases | $ 0 | $ 953,000 |
Finance lease, weighted average remaining term | 1 year 1 month 6 days | |
Finance lease, weighted average discount rate | 9.40% | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 1 year | |
Maximum | ||
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 | Dec. 31, 2021 | Dec. 31, 2020 |
NON-CURRENT ASSETS: | ||
Right-of-use assets, net | $ 1,710 | $ 720 |
CURRENT LIABILITIES: | ||
Accrued expenses | 220 | 405 |
NON-CURRENT LIABILITIES: | ||
Other non-current liabilities | 2,735 | 438 |
Present value of minimum lease payments | $ 2,955 | $ 843 |
Leases (Schedule of Future Mini
Leases (Schedule of Future Minimum Operating Lease Payments) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 275 | |
2023 | 722 | |
2024 | 693 | |
2025 | 474 | |
2026 | 488 | |
Thereafter | 1,555 | |
Total | 4,207 | |
Less amount representing interest | (1,252) | |
Present value of minimum lease payments | 2,955 | $ 843 |
Less current portion | (220) | (405) |
Non-current portion | $ 2,735 | $ 438 |
Leases (Summary of Finance Leas
Leases (Summary of Finance Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | $ 392 | $ 810 |
CURRENT LIABILITIES: | ||
Finance lease obligations | 269 | 209 |
NON-CURRENT LIABILITIES: | ||
Finance lease obligations — less current portion | 225 | 514 |
Total lease liabilities | $ 494 | $ 723 |
Leases (Schedule of Future Mi_2
Leases (Schedule of Future Minimum Finance Lease Payments) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2022 | $ 376 | |
2023 | 236 | |
Total | 612 | |
Less amount representing interest | (118) | |
Total lease liabilities | 494 | $ 723 |
Less current portion | (269) | (209) |
Non-current portion | $ 225 | $ 514 |
Going Concern (Narrative) (Deta
Going Concern (Narrative) (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Instrument [Line Items] | ||
Accumulated deficit | $ 397,281,000 | $ 392,909,000 |
Cash and cash equivalents | 16,510,000 | $ 11,208,000 |
2019 Solar Loan Agreement [Member] | Solar Capital | ||
Debt Instrument [Line Items] | ||
Debt instrument, face amount | $ 45,000,000 |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory | ||
Component parts | $ 200 | $ 623 |
Work-in-process | 1,416 | 1,221 |
Finished goods | 1,063 | 902 |
Total inventory | $ 2,679 | $ 2,746 |
Property And Equipment (Details
Property And Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 6,213 | $ 5,585 |
Less accumulated depreciation and amortization | (3,430) | (3,947) |
Property and equipment — net | 2,783 | 1,638 |
Depreciation expense | 639 | 730 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 226 | 392 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 461 | 547 |
Finance leases | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 974 | 1,117 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,236 | 1,308 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,380 | 486 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,936 | $ 1,735 |
Intangible Asset (Narrative) (D
Intangible Asset (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2014 | Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | |||
Useful life (in years) | 13 years | ||
Net intangible assets | $ 10,897 | $ 12,838 | |
License Agreement [Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Gross intangible assets | $ 25,000 | ||
Useful life (in years) | 13 years | ||
Amortization of intangible assets | $ 1,940 | 1,946 | |
Net intangible assets | $ 10,897 | $ 12,838 | |
EyePoint Member] | |||
Finite-Lived Intangible Assets [Line Items] | |||
Milestone payment after the first product approved by the FDA | $ 25,000 |
Intangible Asset (Future Amorti
Intangible Asset (Future Amortization) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2022 | $ 1,940 | |
2023 | 1,940 | |
2024 | 1,946 | |
2025 | 1,940 | |
2026 | 1,940 | |
Thereafter | 1,191 | |
Total | 10,897 | $ 12,838 |
License Agreement [Member] | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Total | $ 10,897 | $ 12,838 |
Accrued Expenses (Summary of Ac
Accrued Expenses (Summary of Accrued Expenses) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses [Abstract] | ||
Accrued clinical investigator expenses | $ 25 | |
Accrued compensation expenses | $ 2,182 | 1,372 |
Accrued rebate and other revenue reserves | 658 | 1,116 |
Accrued lease liabilities (note 4) | 220 | 405 |
Other accrued expenses | 557 | 279 |
Total accrued expenses | $ 3,617 | $ 3,197 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) - USD ($) $ in Thousands | Dec. 17, 2020 | Dec. 13, 2020 | Dec. 12, 2018 | Jul. 10, 2017 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Possible reversion period | 60 days | ||||||
Collaborative Arrangement, Co-promotion | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Share of net profits | 20.00% | ||||||
Collaborative arrangement, royalty payable on net revenue, percentage | 2.00% | ||||||
Collaborative arrangement, increase in royalty payable on net revenue (as a percentage) | 6.00% | ||||||
Collaborative arrangement, royalty payable on net revenue over threshold, percentage | 2.00% | ||||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000 | ||||||
Royalty expense | $ 2,949 | $ 2,064 | |||||
Reduction in royalty on net revenues up to threshold, first two years (as a percentage) | 4.00% | ||||||
Reduction in royalty on net revenues up to threshold, third year and thereafter (as a percentage) | 5.20% | ||||||
Reduction in royalty on net revenues in excess of threshold, third year and thereafter (as a percentage) | 6.80% | ||||||
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 | ||||||
Collaborative Arrangement, Co-promotion | Accounts Payable | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Accrued royalty expense | $ 719 | ||||||
EyePoint Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000 | ||||||
Collaborative arrangement, royalty payable on net revenue, including additional threshold (as a percentage) | 8.00% | ||||||
EyePoint Member] | Maximum | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Recoverable amount to offset future royalty payments | $ 15,000 | ||||||
New Collaboration Agreement, 2017 Second Amended | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Royalty future offset | 7,419 | ||||||
New Collaboration Agreement, 2017 Second Amended | EyePoint Pharmaceuticals [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payment from related party | $ 16,500 | ||||||
Ocumension [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payment from related party | 10,000 | ||||||
Revenue from related party | $ 11,048 | ||||||
License agreement, shares purchased | 1,000,000 | ||||||
License agreement, share purchase duration | 4 years | ||||||
Deferred revenue related party | $ 300 | ||||||
Ocumension [Member] | Milestone One [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Payment from related party | $ 89,000 |
Other Agreements With Ocumens_2
Other Agreements With Ocumension (Narrative) (Details) - Apr. 14, 2021 - Ocumension [Member] $ / shares in Units, $ in Thousands | USD ($)$ / sharesshares | $ / sharesshares |
Related Party Transaction [Line Items] | ||
Partnership agreement, shares sold | 1,144,945 | |
Partnership agreement, price per share | $ / shares | $ 8.734044 | |
Partnership agreement, percentage of shares outstanding before closing | 19.90% | |
Partnership agreement, consideration received | $ | $ 10,000 | |
Class of warrant or right, number of securities called by warrants or rights (in shares) | 1,000,000 | 1,000,000 |
Partnership agreement, warrant or rights period | 4 years | |
Exchange rate | 0.12853 | 0.12853 |
Class of warrant or right, exercise price of warrants or rights (per share) | (per share) | $ 3.07 | $ 23.88 |
Loan Agreements (Solar Capital
Loan Agreements (Solar Capital Loan Agreement) (Narrative) (Details) - Solar Capital Ltd. - USD ($) | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2019 | Dec. 31, 2020 | Feb. 21, 2020 | Jan. 05, 2018 | |
2018 Solar Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Line of credit facility, maximum borrowing capacity | $ 40,000,000 | ||||
Debt instrument prepayment fee paid | $ 400,000 | $ 2,300,000 | |||
Debt instrument repayment fee amount, paid | 1,800,000 | 2,200,000 | |||
Debt instrument, exit fee | 2,000,000 | ||||
2018 Solar Term Loan [Member] | Tranche One | |||||
Debt Instrument [Line Items] | |||||
Milestone revenue requirement | $ 80,000,000 | ||||
Milestone period requirement | 12 months | ||||
2018 Solar Term Loan [Member] | Tranche Two | |||||
Debt Instrument [Line Items] | |||||
Milestone revenue requirement | $ 100,000,000 | ||||
2019 Solar Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Line of credit facility, maximum borrowing capacity | 45,000,000 | ||||
Line of credit | $ 42,500,000 | $ 45,000,000 | $ 2,500,000 | ||
Debt instrument, interest rate, stated percentage | 7.65% | ||||
Interest rate effective percentage | 9.43% | ||||
2019 Solar Loan Agreement [Member] | London Interbank Offered Rate (LIBOR) | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, basis spread on variable rate | 1.78% | ||||
Second Amendment 2019 Solar Capital Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Loan amendment, minimum revenue amount trailing period | 6 months | ||||
Loan amendment, period for approval | 15 days | ||||
2018 Exit Fee Agreement | 2018 Solar Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, exit fee | $ 2,000,000 | ||||
2019 Exit Fee Agreement [Member] | 2019 Solar Loan Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, exit fee | $ 675,000 | ||||
Debt instrument, exit fee agreement, term | 10 years | ||||
Achievement Of Milestone [Member] | 2018 Solar Term Loan [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, exit fee | $ 1,000,000 |
Loan Agreements (Modification o
Loan Agreements (Modification of Debt) (Narrative) (Details) - Solar Capital Ltd. - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2019 | |
2019 Solar Loan Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Deferred financing costs | $ 427 | |
Debt instrument, fee amount | 76 | |
2018 Solar Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument repayment fee amount, paid | $ 1,800 | 2,200 |
Debt instrument prepayment fee paid | $ 400 | $ 2,300 |
Loan Agreements (Paycheck Prote
Loan Agreements (Paycheck Protection Program) (Narrative) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Apr. 22, 2020 | |
Debt Instrument [Line Items] | ||
Gain on extinguishment of debt | $ 1,792,000 | |
PPP Loan [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument, face amount | $ 1,778,000 | |
Gain on extinguishment of debt | $ 1,792,000 |
Commitments And Contingencies_2
Commitments And Contingencies (Narrative) (Details) $ in Thousands | Jan. 01, 2021USD ($)employee | Feb. 29, 2016 | Dec. 31, 2021USD ($)employeeitem | Dec. 31, 2020USD ($)item | Dec. 31, 2019USD ($) |
Commitments and Contingencies [Line Items] | |||||
Number of executives in employment agreements | employee | 4 | 4 | |||
ILUVIEN [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Contract extension terms | 5 years | ||||
Renewal option additional period | 1 year | ||||
Prior written notice period | 12 months | ||||
Percentage of order of ILUVIEN units required | 80.00% | ||||
Cadence [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Contract extension terms | 24 months | ||||
Renewal option additional period | 1 year | ||||
CRO [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Number of enrolled treatment-naive | item | 300 | 300 | |||
Number of patient sites | item | 42 | 42 | |||
Expense associated with study commitment | $ 3,824 | $ 1,291 | |||
Expected expense to be incurred from study commitment | 12,744 | ||||
Minimum | |||||
Commitments and Contingencies [Line Items] | |||||
Executives salaries | $ 330 | ||||
Employment agreement, period in which the company will be liable for salary and benefits | 1 year | ||||
Maximum | |||||
Commitments and Contingencies [Line Items] | |||||
Executives salaries | $ 580 | ||||
Employment agreement, period in which the company will be liable for salary and benefits | 18 months | ||||
2019 Solar Loan Agreement [Member] | Solar Capital Ltd. | |||||
Commitments and Contingencies [Line Items] | |||||
Debt instrument, repayment fee | $ 2,250 | ||||
Accrued and unpaid interest payable on Note Payable | $ 365 | $ 365 |
Commitments And Contingencies_3
Commitments And Contingencies (Schedule of Future Minimum Principal Payments Under Note Payable) (Details) - 2019 Solar Loan Agreement [Member] $ in Thousands | Dec. 31, 2021USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2023 | $ 28,421 |
2024 | 16,579 |
Total | 45,000 |
Less unamortized debt discount and deferred financing costs | (1,920) |
Non-current portion | $ 43,080 |
Preferred Stock (Series A Conve
Preferred Stock (Series A Convertible Preferred Stock) (Narrative) (Details) - Series A convertible preferred stock - shares | Dec. 31, 2021 | Dec. 31, 2020 |
Conversion of Stock [Line Items] | ||
Preferred stock, shares issued (in shares) | 600,000 | 600,000 |
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 |
Stock Incentive Plans (Narrativ
Stock Incentive Plans (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 997,000 | $ 1,331,000 | |
Weighted average contractual term | 4 years 6 months 25 days | ||
Dividend yield | 0.00% | ||
Expected dividend payments | $ 0 | ||
Total estimated fair value of options granted | $ 835,000 | $ 831,000 | |
Exercise of stock options (in shares) | 6,397 | 0 | |
Total estimated intrinsic value of options exercised | $ 23,000 | ||
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 | $ 871,000 | $ 1,079,000 | |
Share-based compensation not yet recognized | $ 1,076,000 | ||
Vesting period | 4 years | ||
Weighted average contractual term | 10 years | ||
Total unrecognized compensation cost related to outstanding stock option awards, recognition period (in years) | 2 years 4 months 20 days | ||
Total fair value of shares vested during period | $ 866,000 | ||
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 45,000 | 60,000 | |
RSUs [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | 81,000 | $ 192,000 | |
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized share based compensation expense | $ 190,000 | ||
Weighted average period | 2 years 6 months 29 days |
Stock Incentive Plans (Summary
Stock Incentive Plans (Summary of Stock Option Transactions) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||
Options outstanding at beginning of period (in shares) | 939,379 | 871,472 |
Grants (in shares) | 228,805 | 200,081 |
Forfeitures and expirations (in shares) | (85,992) | (132,174) |
Exercises (in shares) | (6,397) | 0 |
Options outstanding at year end (in shares) | 1,075,795 | 939,379 |
Options exercisable at year end (in shares) | 809,837 | 701,725 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 3.65 | $ 4.16 |
Weighted Average Exercise Price ($) | ||
Options outstanding at beginning of period (usd per share) | 26.72 | 35.46 |
Grants (usd per share) | 5.63 | 6.69 |
Forfeitures and expirations (usd per share) | 14.25 | 54.06 |
Exercises (usd per share) | 6.59 | |
Options outstanding at year end (usd per share) | 23.35 | 26.72 |
Options exercisable at year end (usd per share) | $ 28.76 | $ 32.46 |
Stock Incentive Plans (Summar_2
Stock Incentive Plans (Summary of Additional Stock Option Transactions) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2019 | |
Outstanding Stock Options | |||
Outstanding, shares (in shares) | 939,379 | 1,075,795 | 871,472 |
Outstanding, weighted average exercise price (usd per share) | $ 26.72 | $ 23.35 | $ 35.46 |
Outstanding, weighted average remaining contractual term | 5 years 6 months 21 days | ||
Outstanding, aggregate intrinsic value | $ 21 | ||
Exercisable Stock Options | |||
Exercisable, shares (in shares) | 701,725 | 809,837 | |
Exercisable, weighted average exercise price (usd per share) | $ 32.46 | $ 28.76 | |
Exercisable, weighted average remaining contractual term | 4 years 6 months 25 days | ||
Exercisable, aggregate intrinsic value | $ 5 | ||
Exercisable and expected to vest | |||
Outstanding, vested and expected to vest, shares (in shares) | 1,043,347 | ||
Outstanding, vested and expected to vest, weighted average exercise price (usd per share) | $ 28.76 | ||
Outstanding, vested and expected to vest, weighted average remaining contractual term | 5 years 5 months 15 days | ||
Outstanding, vested and expected to vest, aggregate intrinsic value | $ 19 |
Stock Incentive Plans (Weighted
Stock Incentive Plans (Weighted-Average Assumptions Used for Option Grants) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stock Incentive Plans [Abstract] | ||
Risk-free interest rate (percent) | 0.66% | 1.47% |
Volatility factor (percent) | 74.47% | 69.20% |
Grant date fair value of common stock options (usd per share) | $ 3.65 | $ 4.16 |
Weighted-average expected life | 6 years 10 days | 6 years 7 days |
Assumed forfeiture rate (percent) | 10.00% | 10.00% |
Stock Incentive Plans (Employee
Stock Incentive Plans (Employee Stock-Based Compensation Expense) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | $ 997,000 | $ 1,331,000 | |
Stock options [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | 871,000 | 1,079,000 | |
Stock options [Member] | Sales and marketing | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | 199,000 | 244,000 | |
Stock options [Member] | Research, development and medical affairs | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | 77,000 | 116,000 | |
Stock options [Member] | General and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | 595,000 | 719,000 | |
Employee Stock Purchase Plan [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | $ 45,000 | 60,000 | |
RSUs [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense related to stock options | $ 81,000 | $ 192,000 |
Stock Incentive Plans (Summar_3
Stock Incentive Plans (Summary of Restricted Stock and Restricted Stock Unit Transactions) (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Restricted Stock & RSUs | ||
Restricted stock units & RSUs outstanding at beginning of period (in shares) | 30,086 | 36,763 |
Grants (in shares) | 55,500 | 30,086 |
Vested units (in shares) | (25,403) | (36,763) |
Forfeitures (in shares) | (13,933) | |
Restricted stock units outstanding at year end (in shares) | 46,250 | 30,086 |
Weighted Average Grant Date Fair Value ($) | ||
Restricted stock units outstanding at beginning of period (usd per share) | $ 3.12 | $ 13.15 |
Grants (usd per share) | 5.73 | 3.12 |
Vested units (usd per share) | 3.12 | 13.15 |
Forfeitures (usd per share) | 5.15 | |
Restricted stock units & RSUs outstanding at year end (usd per share) | $ 5.65 | $ 3.12 |
Concentrations And Credit Risk
Concentrations And Credit Risk (Narrative) (Details) | 12 Months Ended | |
Dec. 31, 2021itemcustomer | Dec. 31, 2020customer | |
Sales [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Number of customers | 2 | 2 |
Sales [Member] | Customer Concentration Risk [Member] | Large Pharmaceutical Distributors [Member] | ||
Concentration Risk [Line Items] | ||
Number of customers | 2 | 2 |
Concentration risk percentage | 55.00% | 49.00% |
Sales [Member] | Customer Concentration Risk [Member] | United States | ||
Concentration Risk [Line Items] | ||
Number of customers | 3 | 3 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | ||
Concentration Risk [Line Items] | ||
Number of customers | 2 | 2 |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Large Pharmaceutical Distributors [Member] | ||
Concentration Risk [Line Items] | ||
Number of customers | 2 | 2 |
Concentration risk percentage | 68.00% | 67.00% |
Purchases [Member] | Supplier Concentration Risk [Member] | Third-party Manufacturer [Member] | ||
Concentration Risk [Line Items] | ||
Number of vendors | 1 | |
Concentration risk percentage | 12.00% | |
Purchases [Member] | Third-party Manufacturer [Member] | Third-party Manufacturer [Member] | ||
Concentration Risk [Line Items] | ||
Number of vendors | item | 1 | |
Concentration risk percentage | 14.00% |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards [Line Items] | ||
Income tax expense (benefit), CARES ACT | $ 0 | |
Unrecognized tax benefits, related to research and development tax credits | 88,000 | $ 65,000 |
Net operating loss carry-forwards | 143,200,000 | 131,400,000 |
Operating loss carryforwards, not utilized in the future | 18,600,000 | |
Federal tax credits, not utilized in the future | 382,000 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | $ 106,700,000 | $ 96,200,000 |
Income Taxes (Components of Net
Income Taxes (Components of Net Loss before Taxes) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes [Abstract] | ||
United States | $ (10,241) | $ (5,535) |
Foreign | 6,307 | 128 |
NET LOSS BEFORE TAXES | $ (3,934) | $ (5,407) |
Income Taxes (Components of Inc
Income Taxes (Components of Income Tax Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Current expense (benefit): | ||
Foreign | $ (172) | $ (37) |
Current income tax benefit | (172) | (37) |
Deferred benefit (expense): | ||
Federal | (1,084) | |
State | (350) | |
Foreign | 610 | (31) |
Deferred benefit (expense), gross | 610 | (1,465) |
Valuation allowance | 1,434 | |
Deferred income tax expense (benefit) | 610 | (31) |
Total income tax expense (benefit) | $ 438 | $ (68) |
Income Taxes (Summary of Valuat
Income Taxes (Summary of Valuation Allowance) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes [Abstract] | ||
Valuation allowance at beginning of period | $ (38,882) | $ (37,448) |
Increase in valuation allowance | (9,973) | (1,434) |
Valuation allowance at end of period | $ (48,855) | $ (38,882) |
Income Taxes (Net Deferred Tax
Income Taxes (Net Deferred Tax Assets) (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets | |||
Depreciation and amortization | $ 27 | $ 69 | |
Intangible Assets | 7,692 | ||
Other deferred tax assets | 829 | 948 | |
NOL carry-forwards | 35,335 | 31,832 | |
Equity compensation | 3,347 | 4,902 | |
Collaboration agreement receivable reserves | 1,762 | 1,884 | |
Valuation allowance | (48,855) | (38,882) | $ (37,448) |
Total deferred tax assets | $ 137 | $ 753 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of Income Tax Benefit to Amount Determined by Applying U.S. Federal Statutory Income Tax Rate) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Amount | ||
Federal tax benefit at statutory rate | $ (826) | $ (1,135) |
State tax — net of federal benefit | 24 | 350 |
Permanent items and other | 240 | 151 |
Foreign rate differential | (1,374) | 52 |
Deferred rate change | (215) | 6 |
Tax effect of intellectual property migration | (8,547) | |
Tax credits and true-ups | 1,211 | (226) |
Increase in valuation allowance | 9,973 | 1,434 |
Total income tax expense (benefit) | $ 438 | $ (68) |
Percent | ||
Federal tax benefit at statutory rate | 21.00% | 21.00% |
State tax — net of federal benefit | 0.60% | 6.50% |
Permanent items and other | (6.10%) | (2.80%) |
Foreign rate differential | 34.90% | (1.00%) |
Deferred rate change | 5.50% | (0.10%) |
Tax effect of intellectual property migration | 217.20% | |
Tax credits and true-ups | (30.70%) | 4.10% |
Increase in valuation allowance | (253.50%) | (26.50%) |
Total tax expense (benefit) | (11.10%) | 1.20% |
Income Taxes (Uncertain Tax Pos
Income Taxes (Uncertain Tax Positions Rollforward) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance of uncertain tax positions at beginning of period | $ 65 | $ 58 |
Gross increases - tax positions in current period | 29 | 10 |
Gross decreases - tax positions in prior period | (6) | (3) |
Balance of uncertain tax positions at end of period | $ 88 | $ 65 |
Employee Benefit Plans (Narrati
Employee Benefit Plans (Narrative) (Details) | Jan. 01, 2022shares | Jan. 01, 2021shares | Dec. 31, 2021USD ($)itemshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2010shares |
Defined Benefit Plan Disclosure [Line Items] | |||||
Compensation expense associated with the Company's matching plan | $ | $ 431,000 | $ 248,000 | |||
Annual discretionary profit-sharing contribution | $ | $ 0 | 0 | |||
Purchase price of stock under ESPP as a percentage of fair market value of common stock | 85.00% | ||||
Employee stock purchase plan, number of purchase periods | item | 2 | ||||
Employee stock purchase plan, purchase period | 6 months | ||||
Percentage of eligible compensation that may be contributed towards ESPP | 15.00% | ||||
Maximum number of shares of common stock a participant may purchase per purchase period (in shares) | shares | 500 | ||||
Maximum value of shares of common stock a participant may purchase in any calendar year | $ | $ 25,000 | ||||
Total employee stock-based compensation expense related to stock options | $ | $ 997,000 | $ 1,331,000 | |||
Employee Stock Purchase Plan [Member] | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Purchase price of stock under ESPP as a percentage of fair market value of common stock | 85.00% | ||||
Common stock, available for sale under employee stock purchase plan (in shares) | shares | 32,961 | ||||
Common shares acquired through employee stock purchase plan (in shares) | shares | 22,878 | 13,812 | |||
Additional shares that became available for future issuance under the Purchase Plan (in shares) | shares | 13,812 | ||||
Total employee stock-based compensation expense related to stock options | $ | $ 45,000 | $ 60,000 | |||
Subsequent Event | Employee Stock Purchase Plan [Member] | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Additional shares that became available for future issuance under the Purchase Plan (in shares) | shares | 22,878 |
Segment Information (Narrative)
Segment Information (Narrative) (Details) - Customer Concentration Risk [Member] - customer | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Sales [Member] | ||
Segment Reporting Information [Line Items] | ||
Number of customers | 2 | 2 |
Accounts Receivable [Member] | ||
Segment Reporting Information [Line Items] | ||
Number of customers | 2 | 2 |
Large Pharmaceutical Distributors [Member] | Sales [Member] | ||
Segment Reporting Information [Line Items] | ||
Number of customers | 2 | 2 |
Concentration risk percentage | 55.00% | 49.00% |
Large Pharmaceutical Distributors [Member] | Accounts Receivable [Member] | ||
Segment Reporting Information [Line Items] | ||
Number of customers | 2 | 2 |
Concentration risk percentage | 68.00% | 67.00% |
Segment Information (Summary of
Segment Information (Summary of Operations by Segment) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Segment Reporting Information [Line Items] | ||
NET REVENUE | $ 59,029 | $ 50,820 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (7,030) | (6,941) |
GROSS PROFIT | 51,999 | 43,879 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 13,778 | 9,668 |
GENERAL AND ADMINISTRATIVE EXPENSES | 12,774 | 11,652 |
SALES AND MARKETING EXPENSES | 23,069 | 20,384 |
DEPRECIATION AND AMORTIZATION | 2,579 | 2,676 |
OPERATING EXPENSES | 52,200 | 44,380 |
LOSS FROM OPERATIONS | (201) | (501) |
OTHER INCOME AND EXPENSES, NET | (3,733) | (4,906) |
NET LOSS BEFORE TAXES | (3,934) | (5,407) |
United States Segment [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 26,740 | 24,809 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (3,298) | (2,858) |
GROSS PROFIT | 23,442 | 21,951 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,628 | 3,137 |
GENERAL AND ADMINISTRATIVE EXPENSES | 969 | 924 |
SALES AND MARKETING EXPENSES | 15,348 | 13,784 |
OPERATING EXPENSES | 19,945 | 17,845 |
LOSS FROM OPERATIONS | 3,497 | 4,106 |
International Segment [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 32,289 | 26,011 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (3,732) | (4,083) |
GROSS PROFIT | 28,557 | 21,928 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 4,197 | 2,996 |
GENERAL AND ADMINISTRATIVE EXPENSES | 1,322 | 1,481 |
SALES AND MARKETING EXPENSES | 6,953 | 5,790 |
OPERATING EXPENSES | 12,472 | 10,267 |
LOSS FROM OPERATIONS | 16,085 | 11,661 |
Operating Cost [Member] | ||
Segment Reporting Information [Line Items] | ||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 5,850 | 3,386 |
GENERAL AND ADMINISTRATIVE EXPENSES | 9,828 | 8,378 |
SALES AND MARKETING EXPENSES | 529 | 489 |
OPERATING EXPENSES | 16,207 | 12,253 |
LOSS FROM OPERATIONS | (16,207) | (12,253) |
Other Segments [Member] | ||
Segment Reporting Information [Line Items] | ||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 103 | 149 |
GENERAL AND ADMINISTRATIVE EXPENSES | 655 | 869 |
SALES AND MARKETING EXPENSES | 239 | 321 |
DEPRECIATION AND AMORTIZATION | 2,579 | 2,676 |
OPERATING EXPENSES | 3,576 | 4,015 |
LOSS FROM OPERATIONS | (3,576) | (4,015) |
OTHER INCOME AND EXPENSES, NET | (3,733) | (4,906) |
Product [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 47,981 | 50,820 |
Product [Member] | United States Segment [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 26,740 | 24,809 |
Product [Member] | International Segment [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 21,241 | $ 26,011 |
License [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | 11,048 | |
License [Member] | International Segment [Member] | ||
Segment Reporting Information [Line Items] | ||
NET REVENUE | $ 11,048 |
Fair Value (Fair Value Of Asset
Fair Value (Fair Value Of Assets And Liabilities) (Details) - Fair Value, Recurring [Member] $ in Thousands | Dec. 31, 2021USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Warrant asset | $ 833 |
Assets measured at fair value | 833 |
Fair Value, Inputs, Level 2 [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Warrant asset | 833 |
Assets measured at fair value | $ 833 |