Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 11, 2021 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 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 | 6120 Windward Parkway | |
Entity Address, Address Line Two | Suite 290 | |
Entity Address, City or Town | Alpharetta | |
Entity Address, State or Province | GA | |
Entity Address, Postal Zip Code | 30005 | |
City Area Code | 678 | |
Local Phone Number | 990-5740 | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Trading Symbol | ALIM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Smaller Reporting Company | true | |
Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity common stock, shares outstanding (in shares) | 6,924,174 | |
Entity Central Index Key | 0001267602 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 24,780 | $ 11,208 |
Restricted cash | 35 | 34 |
Accounts receivable, net | 15,086 | 17,200 |
Prepaid expenses and other current assets | 3,029 | 3,718 |
Inventory (Note 7) | 2,307 | 2,746 |
Total current assets | 45,237 | 34,906 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | 1,516 | 1,638 |
Right of use assets, net | 683 | 720 |
Intangible asset, net (Note 8) | 11,875 | 12,838 |
Deferred tax asset | 729 | 753 |
Warrant asset | 2,062 | |
TOTAL ASSETS | 62,102 | 50,855 |
CURRENT LIABILITIES: | ||
Accounts payable | 7,083 | 7,461 |
Accrued expenses | 2,924 | 3,197 |
Paycheck Protection Program (PPP) loan (Note 10) | 1,481 | |
Finance lease obligations | 301 | 209 |
Total current liabilities | 10,308 | 12,348 |
NON-CURRENT LIABILITIES: | ||
Notes payable, net of discount (Note 10) | 42,595 | 42,408 |
Other non-current liabilities | 3,308 | 4,077 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS’ EQUITY (DEFICIT): | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 6,924,174 shares issued and outstanding at June 30, 2021 and 5,719,367 shares issued and outstanding at December 31, 2020 | 69 | 57 |
Additional paid-in capital | 376,334 | 365,830 |
Common stock warrants | 370 | 370 |
Accumulated deficit | (388,992) | (392,909) |
Accumulated other comprehensive loss | (1,117) | (553) |
TOTAL STOCKHOLDERS’ EQUITY (DEFICIT) | 5,891 | (7,978) |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | 62,102 | 50,855 |
Series A convertible preferred stock | ||
STOCKHOLDERS’ EQUITY (DEFICIT): | ||
Preferred stock, $.01 par value — 10,000,000 shares authorized at June 30, 2021 and December 31, 2020: Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at June 30, 2021 and December 31, 2020; liquidation preference of $24,000 at June 30, 2021 and December 31, 2020 | $ 19,227 | $ 19,227 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 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) | 6,924,174 | 5,719,367 |
Common stock, shares outstanding (in shares) | 6,924,174 | 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements Of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
NET REVENUE | $ 21,703 | $ 10,038 | $ 32,917 | $ 24,573 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,813) | (1,485) | (3,375) | (3,412) |
GROSS PROFIT | 19,890 | 8,553 | 29,542 | 21,161 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,567 | 1,810 | 6,780 | 4,693 |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,356 | 2,791 | 6,769 | 5,773 |
SALES AND MARKETING EXPENSES | 5,331 | 4,566 | 10,149 | 10,437 |
DEPRECIATION AND AMORTIZATION | 633 | 685 | 1,271 | 1,339 |
OPERATING EXPENSES | 12,887 | 9,852 | 24,969 | 22,242 |
INCOME (LOSS) FROM OPERATIONS | 7,003 | (1,299) | 4,573 | (1,081) |
INTEREST EXPENSE AND OTHER | (1,347) | (1,351) | (2,690) | (2,643) |
UNREALIZED FOREIGN CURRENCY GAIN, NET | 56 | 109 | 181 | 28 |
GAIN ON EXTINGUISHMENT OF DEBT | 1,792 | 1,792 | ||
CHANGE IN FAIR VALUE OF WARRANT ASSET | 701 | 701 | ||
NET INCOME (LOSS) BEFORE TAXES | 8,205 | (2,541) | 4,557 | (3,696) |
PROVISION FOR TAXES | (640) | (5) | (640) | (48) |
NET INCOME (LOSS) | 7,565 | (2,546) | 3,917 | (3,744) |
NET (LOSS) INCOME AVAILABLE TO STOCKHOLDERS | $ 7,565 | $ (2,546) | $ 3,917 | $ (3,744) |
NET INCOME (LOSS) PER SHARE — Basic and diluted | $ 1.03 | $ (0.51) | $ 0.57 | $ (0.75) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic | 7,351,919 | 5,030,833 | 6,857,172 | 5,005,777 |
NET INCOME (LOSS) PER SHARE — Diluted | $ 1.03 | $ (0.51) | $ 0.57 | $ (0.75) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Diluted | 7,363,150 | 5,030,833 | 6,857,172 | 5,005,777 |
Product [Member] | ||||
NET REVENUE | $ 10,655 | $ 10,038 | $ 21,869 | $ 24,573 |
License [Member] | ||||
NET REVENUE | $ 11,048 | $ 11,048 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Condensed Consolidated Statements Of Comprehensive Loss [Abstract] | ||||
NET INCOME (LOSS) | $ 7,565 | $ (2,546) | $ 3,917 | $ (3,744) |
OTHER COMPREHENSIVE INCOME (LOSS) | ||||
Foreign currency translation adjustments | 33 | 93 | (564) | 7 |
TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | 33 | 93 | (564) | 7 |
COMPREHENSIVE INCOME (LOSS) | $ 7,598 | $ (2,453) | $ 3,353 | $ (3,737) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements Of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income (loss) | $ 3,917,000 | $ (3,744,000) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation and amortization | 1,271,000 | 1,339,000 |
Non-cash consideration received as revenue | (973,000) | |
Unrealized foreign currency transaction gain, net | (181,000) | (28,000) |
Amortization of debt discount | 480,000 | 481,000 |
Share-based compensation expense | 514,000 | 757,000 |
Gain on extinguishment of debt | (1,792,000) | |
Change in fair value of warrant asset | (701,000) | |
Changes in assets and liabilities: | ||
Accounts receivable | 2,019,000 | 5,305,000 |
Prepaid expenses and other current assets | 646,000 | (238,000) |
Inventory | 408,000 | (582,000) |
Accounts payable | (252,000) | (1,211,000) |
Accrued expenses and other current liabilities | (226,000) | (1,568,000) |
Other long-term liabilities | (939,000) | (293,000) |
Net cash provided by operating activities | 4,191,000 | 218,000 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (190,000) | (217,000) |
Net cash used in investing activities | (190,000) | (217,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock | 10,042,000 | 10,000 |
Common stock issuance costs | (81,000) | |
Proceeds from exercise of stock options | 42,000 | |
Issuance of debt | 4,278,000 | |
Payment of debt costs | (19,000) | |
Payment of finance lease obligations | (112,000) | (231,000) |
Net cash provided by financing activities | 9,891,000 | 4,038,000 |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (319,000) | 29,000 |
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 13,573,000 | 4,068,000 |
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 period | 24,815,000 | 13,527,000 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 2,145,000 | 1,084,000 |
Cash paid for income taxes | 23,000 | 30,000 |
Supplemental schedule of non-cash investing and financing activities: | ||
Property and equipment acquired under finance leases | 0 | 495,000 |
Property and equipment acquired under operating leases | 157,000 | 0 |
Note payable end of term payment accrued but unpaid | $ 1,800,000 | $ 1,800,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements Of Changes in Shareholders' Equity (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) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 62,933 | |||||||
Stock-based compensation expense | 440 | 440 | ||||||
Other | (115) | (115) | ||||||
Net income (loss) | (1,198) | (1,198) | ||||||
Foreign currency translation adjustments | (86) | (86) | ||||||
Ending balance (in shares) at Mar. 31, 2020 | 5,028,882 | 600,000 | 10,150 | |||||
Ending balance at Mar. 31, 2020 | $ 50 | $ 19,227 | $ 11,117 | 350,442 | 3,707 | (388,768) | (1,179) | (5,404) |
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) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock option exercises (in shares) | ||||||||
Net income (loss) | $ (3,744) | |||||||
Foreign currency translation adjustments | 7 | |||||||
Ending balance (in shares) at Jun. 30, 2020 | 5,031,745 | 600,000 | 10,150 | |||||
Ending balance at Jun. 30, 2020 | $ 50 | $ 19,227 | $ 11,117 | 350,769 | 3,707 | (391,314) | (1,086) | (7,530) |
Beginning balance (in shares) at Mar. 31, 2020 | 5,028,882 | 600,000 | 10,150 | |||||
Beginning balance at Mar. 31, 2020 | $ 50 | $ 19,227 | $ 11,117 | 350,442 | 3,707 | (388,768) | (1,179) | (5,404) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 2,863 | |||||||
Issuance of common stock, net of issuance costs | 10 | $ 10 | ||||||
Stock option exercises (in shares) | ||||||||
Stock-based compensation expense | 317 | $ 317 | ||||||
Net income (loss) | (2,546) | (2,546) | ||||||
Foreign currency translation adjustments | 93 | 93 | ||||||
Ending balance (in shares) at Jun. 30, 2020 | 5,031,745 | 600,000 | 10,150 | |||||
Ending balance at Jun. 30, 2020 | $ 50 | $ 19,227 | $ 11,117 | 350,769 | 3,707 | (391,314) | (1,086) | (7,530) |
Beginning balance (in shares) at Dec. 31, 2020 | 5,719,367 | 600,000 | ||||||
Beginning balance at Dec. 31, 2020 | $ 57 | $ 19,227 | 365,830 | 370 | (392,909) | (553) | (7,978) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 45,000 | |||||||
Issuance of common stock, net of issuance costs | $ 1 | 1 | ||||||
Stock option exercises (in shares) | 58 | |||||||
Forfeitures of restricted stock (in shares) | (10,933) | |||||||
Stock-based compensation expense | 262 | 262 | ||||||
Net income (loss) | (3,648) | (3,648) | ||||||
Foreign currency translation adjustments | (597) | (597) | ||||||
Ending balance (in shares) at Mar. 31, 2021 | 5,753,492 | 600,000 | ||||||
Ending balance at Mar. 31, 2021 | $ 58 | $ 19,227 | 366,092 | 370 | (396,557) | (1,150) | (11,960) | |
Beginning balance (in shares) at Dec. 31, 2020 | 5,719,367 | 600,000 | ||||||
Beginning balance at Dec. 31, 2020 | $ 57 | $ 19,227 | 365,830 | 370 | (392,909) | (553) | $ (7,978) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock option exercises (in shares) | 6,397 | |||||||
Net income (loss) | $ 3,917 | |||||||
Foreign currency translation adjustments | (564) | |||||||
Ending balance (in shares) at Jun. 30, 2021 | 6,924,174 | 600,000 | ||||||
Ending balance at Jun. 30, 2021 | $ 69 | $ 19,227 | 376,334 | 370 | (388,992) | (1,117) | 5,891 | |
Beginning balance (in shares) at Mar. 31, 2021 | 5,753,492 | 600,000 | ||||||
Beginning balance at Mar. 31, 2021 | $ 58 | $ 19,227 | 366,092 | 370 | (396,557) | (1,150) | (11,960) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,164,343 | |||||||
Issuance of common stock, net of issuance costs | $ 11 | 9,949 | $ 9,960 | |||||
Stock option exercises (in shares) | 6,339 | 6,339 | ||||||
Stock option exercises | 42 | $ 42 | ||||||
Stock-based compensation expense | 251 | 251 | ||||||
Net income (loss) | 7,565 | 7,565 | ||||||
Foreign currency translation adjustments | 33 | 33 | ||||||
Ending balance (in shares) at Jun. 30, 2021 | 6,924,174 | 600,000 | ||||||
Ending balance at Jun. 30, 2021 | $ 69 | $ 19,227 | $ 376,334 | $ 370 | $ (388,992) | $ (1,117) | $ 5,891 |
Nature Of Operations
Nature Of Operations | 6 Months Ended |
Jun. 30, 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 development and commercialization of ophthalmic pharmaceuticals. The Company’s only product is ILUVIEN ® (fluocinolone acetonide intravitreal implant) 0.19 mg, which has received marketing authorization 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 and has made ILUVIEN available in the Nordic Region (Denmark, Finland, Norway and Sweden) with the support of an exclusive wholesaler. 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 0.19 mg fluocinolone acetonide intravitreal injection in China, East Asia and the Western Pacific. As of June 30, 2021, the Company has recognized sales of ILUVIEN to its international distributors covering the Middle East, Austria, Belgium, France, Italy, Luxembourg, Spain and the Netherlands. Effects of the COVID-19 Pandemic The 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, 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 our revenues beginning late in the first quarter of 2020 and continuing through the second quarter of 2021. The Company expects these factors to continue to adversely impact our revenue, and the extent and duration of that impact is uncertain at this time, particularly in light of the emergence of COVID-19 variants that increase the transmissibility of the coronavirus and may be more deadly. Depending on the duration of these limitations and the severity and duration of other effects of the COVID-19 pandemic, our 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 continue for an extended period, the continued 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 manage its cost structure where possible to mitigate any anticipated loss of revenue in those markets that are affected. • Because the Company believes that its employees are critical to both (a) serving its customers and patients through alternative forms of engagement as the pandemic-related restrictions continue, and (b) realizing the long-term value of ILUVIEN, the Company has sought to maintain its staffing levels at the historical levels. |
Basis Of Presentation
Basis Of Presentation | 6 Months Ended |
Jun. 30, 2021 | |
Basis Of Presentation [Abstract] | |
Basis Of Presentation | 2. BASIS OF PRESENTATION The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, these Interim Financial Statements do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying Interim Financial Statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information. The accompanying Interim Financial Statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2020 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on March 5, 2021. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. |
Summary Of Significant Accounti
Summary Of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Summary Of Significant Accounting Policies | 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company’s accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2020. Reclassifications Within the operating expenses section of the Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2020 as well as within the International segment (see Note 15), the Company reclassified $ 184,000 and $ 383,000 , respectively, in sales and marketing expenses associated with its country managers in Europe from general and administrative expenses to sales and marketing expenses. The Company made this reclassification to provide additional transparency of the activity being performed and to conform them to the current quarter presentation. These changes had no impact on previously reported consolidated balance sheets, net loss on our statements of operations, comprehensive loss, stockholders’ deficit or cash flows. 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 intraperiod 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. Accounting Standards Issued but Not Yet Effective In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments - Credit Losses (Accounting Standards Codification (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. ASU 2020-04 is effective for all entities as of March 12, 2020 through December 31, 2022. The Company is currently assessing the impact of the optional guidance on the Company’s consolidated financial statements and disclosures. 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 becomes effective for the Company on January 1, 2022. The Company is currently assessing the impact of adoption of the ASU. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2021 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 4. REVENUE RECOGNITION Overview The Company recognizes revenue when a customer obtains control of the related good or service. The amount recognized reflects the consideration the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers , the Company performs the following steps as outlined in the guidance: (1) identify the contract with the customer, (2) identify the performance obligations within the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when the entity satisfies a performance obligation. At the inception of a contract, the contract is evaluated to determine if it falls within the scope of ASC 606, followed by the Company’s assessment of the goods or services promised within each contract, assessment of whether the promised good or service is distinct and determination of the performance obligations. The Company then recognizes revenue based on the transaction price that is allocated to the respective performance obligation when the performance obligation is satisfied. If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. The Company determines standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, the Company estimates the standalone selling price taking into account available information such as market conditions related to the performance obligations. Net Product Sales The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. With respect to the Company’s international contracts with third-party distributors, certain contracts have elements of variable consideration, and management reviews those contracts on a regular basis and makes estimates of revenue based on historical ordering patterns and known market trends 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 either refund the sales price paid by the Customer by issuing a credit or exchange 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 the license agreement may include payment to the Company of 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. 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 606-10-55-65. 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 markets, but generally range between 30 to 120 days. Occasionally, the Company extends the timing of its receipt of payment from the Company’s international 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 in one year or less of receiving those products or services. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Leases | 5. LEASES The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right of use assets and accounts for these, as applicable, at inception of the contract. 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 not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term. Operating Leases The Company’s operating lease activities primarily consist of leases for office space in the U.S., the U.K. and Germany. Most of these leases include options to renew, with renewal terms generally ranging from one to seven years . The exercise of lease renewal options is at the Company’s sole discretion. Certain of the Company’s operating lease agreements include variable lease costs that are based on common area maintenance and property taxes. The Company expenses these payments as incurred. The Company’s operating lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of June 30, 2021 and December 31, 2020 for the Company’s operating leases is as follows: June 30, December 31, 2021 2020 (In thousands) NON-CURRENT ASSETS: Right of use assets, net $ 683 $ 720 Total lease assets $ 683 $ 720 CURRENT LIABILITIES: Accrued expenses $ 261 $ 405 NON-CURRENT LIABILITIES: Other non-current liabilities 488 438 Total lease liabilities $ 749 $ 843 The Company’s operating lease cost for the three and six months ended June 30, 2021 was $ 118,000 and $ 236,000 , respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations. The Company’s operating lease cost for the three and six months ended June 30, 2020 was $ 96,000 and $ 223,000 , respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations. As of June 30, 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) 2021 (remaining) $ 204 2022 230 2023 231 2024 202 Thereafter — Total 867 Less amount representing interest ( 118 ) Present value of minimum lease payments 749 Less current portion (as a portion of accrued expenses) ( 261 ) Non-current portion (as a portion of other non-current liabilities) $ 488 Cash paid for operating leases was $ 298,000 during the six months ended June 30, 2021. Right of use assets of $ 157,000 were obtained in exchange for operating leases for the six months ended June 30, 2021. Cash paid for operating leases was $ 216,000 during the six months ended June 30, 2020. No right of use assets were obtained in exchange for operating leases for the six months ended June 30, 2020. As of June 30, 2021, the weighted average remaining lease terms of the Company’s operating leases was 3.1 years. The weighted average discount rate used to determine the lease liabilities was 9.96 %. Finance Leases The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. Property and equipment leases are capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of June 30, 2021 and December 31, 2020 for the Company’s finance leases is as follows: June 30, December 31, 2021 2020 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 600 $ 810 Total lease assets $ 600 $ 810 CURRENT LIABILITIES: Finance lease obligations $ 301 $ 209 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 309 514 Total lease liabilities $ 610 $ 723 Depreciation expense associated with property and equipment under finance leases was approximately $ 104,000 and $ 112,000 for the three months ended June 30, 2021 and 2020, respectively. Depreciation expense associated with property and equipment under finance leases was approximately $ 209,000 and $ 193,000 for the six months ended June 30, 2021 and 2020, respectively. Interest expense associated with finance leases was $ 15,000 and $ 13,000 for the three months ended June 30, 2021 and 2020, respectively. Interest expense associated with finance leases was $ 32,000 and $ 19,000 for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 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) 2021 (remaining) $ 174 2022 269 2023 129 Total 572 Less amount representing interest ( 70 ) Present value of minimum lease payments 502 Less current portion ( 301 ) Non-current portion $ 201 Cash paid for finance leases was $ 195,000 during the six months ended June 30, 2021. No property and equipment was obtained in exchange for finance leases during the six months ended June 30, 2021. As of June 30, 2021, the weighted average remaining lease terms of the Company’s finance leases was 1.6 years. The weighted average discount rate used to determine the finance lease liabilities was 9.3 %. |
Going Concern
Going Concern | 6 Months Ended |
Jun. 30, 2021 | |
Going Concern [Abstract] | |
Going Concern | 6. GOING CONCERN The accompanying Interim Financial Statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. To date, the Company has incurred recurring losses and negative cash flow from operations and has accumulated a deficit of $ 388,992,000 from inception through June 30, 2021. As of June 30, 2021, the Company had approximately $ 24,780,000 in cash and cash equivalents. On April 14, 2021, the Company entered into four agreements with Ocumension Therapeutics that resulted in gross proceeds to the Company of $ 20,000,000 . However, should the impact of the COVID-19 pandemic be extended, the Company may need to reevaluate its planned expenses and reduce its expenses in the future. 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 Investment Corp., as amended (see Note 10). 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. To meet the Company’s future working capital needs, the Company may need to raise additional debt or equity financing. While the Company from time to time has been able to raise additional capital through issuance of equity and/or debt financing, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity, contain or reduce 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 Interim Financial Statements are issued. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory [Abstract] | |
Inventory | 7. INVENTORY Inventory consisted of the following: June 30, December 31, 2021 2020 (In thousands) Component parts (1) $ 468 $ 623 Work-in-process (2) — 1,221 Finished goods 1,839 902 Total Inventory $ 2,307 $ 2,746 (1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing or stability testing as required by U.S. or EEA regulatory authorities. |
Intangible Asset
Intangible Asset | 6 Months Ended |
Jun. 30, 2021 | |
Intangible Asset [Abstract] | |
Intangible Asset | 8. INTANGIBLE ASSET As a result of the approval of ILUVIEN by the U.S. Food and Drug Administration (FDA) in 2014, the Company was required to pay EyePoint Pharmaceuticals, Inc. (EyePoint) a milestone payment of $ 25,000,000 (see Note 9). The gross carrying amount of the intangible asset is $ 25,000,000 , which is being amortized over approximately 13 years from the payment date. The amortization expense related to the intangible asset was approximately $ 484,000 for both the three months ended June 30, 2021 and 2020, respectively. The amortization expense related to the intangible asset was approximately $ 963,000 and $ 967,000 for the six months ended June 30, 2021 and 2020, respectively. The net book value of the intangible asset was $ 11,875,000 and $ 12,838,000 as of June 30, 2021 and December 31, 2020, respectively. The estimated future amortization expense as of June 30, 2021 for the remaining periods in the next five years and thereafter is as follows: Years Ending December 31 (In thousands) 2021 (remaining) $ 978 2022 1,940 2023 1,940 2024 1,946 2025 1,940 Thereafter 3,131 Total $ 11,875 |
License Agreements
License Agreements | 6 Months Ended |
Jun. 30, 2021 | |
License Agreements [Abstract] | |
License Agreements | 9. LICENSE AGREEMENTS EyePoint Agreement In February 2005, the Company entered into an agreement with EyePoint (formerly known as pSivida US, Inc.) for the use of fluocinolone acetonide (FAc) in EyePoint’s proprietary insert technology. This agreement was subsequently amended a number of times (as amended, the EyePoint Agreement). The EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. In July 2017, the Company amended and restated its license agreement with EyePoint, which was made effective July 1, 2017 (the New Collaboration Agreement). Under the New Collaboration Agreement, the Company has the right to the technology underlying ILUVIEN for the treatment of (a) human eye diseases, including uveitis, in Europe, the Middle East, and Africa, and (b) human eye diseases other than uveitis worldwide. The New Collaboration Agreement converted the Company’s previous profit share obligation to a royalty payable on global net revenues of ILUVIEN. Following the signing of the New Collaboration Agreement, the Company retained a right to recover up to $ 15,000,000 of commercialization costs that were incurred prior to profitability of ILUVIEN and to offset a portion of future payments owed to EyePoint with these accumulated commercialization costs, referred to as the Future Offset. Due to the uncertainty of future net profits, the Company has fully reserved the Future Offset in the accompanying Interim Financial Statements. In March 2019, pursuant to the New Collaboration Agreement, the Company forgave $ 5,000,000 of the Future Offset in connection with the approval of ILUVIEN for NIU-PS in the U.K. As of June 30, 2021, the balance of the Future Offset was approximately $ 7,707,000 . During the three and six months ended June 30, 2020, the royalty amount was 4 %, which was reduced from 6 % due to the recoverable balance of the Future Offset. During the three and six months ended June 30, 2021, the royalty amount was 5.2 %, which was reduced from 6 % due to the recoverable balance of the Future Offset. The Company is required to pay an additional 2 % royalty on future global net revenues and other related consideration in excess of $ 75,000,000 in any year. During the three and six months ended June 30, 2021, the Company recognized approximately $ 1,021,000 and $ 1,605,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. As of June 30, 2021, approximately $ 1,021,000 of this royalty expense was included in the Company’s accounts payable. During the three and six months ended June 30, 2020, the Company recognized approximately $ 401,000 and $ 982,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. Ocumension License Agreement On April 14, 2021, the Company entered into an exclusive license agreement (the License Agreement) with Ocumension (Hong Kong) Limited (“Ocumension HK”), a wholly owned subsidiary of Ocumension Therapeutics, for the development and commercialization under Ocumension HK’s own brand name(s), either directly or through its affiliates or approved third-party sublicensees, of the Company’s 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 $ 10.0 million from Ocumension HK and may in the future receive additional sales-based milestone payments totaling up to $ 89.0 million upon the achievement by Ocumension HK of certain specified sales milestones during the term of the License Agreement. The Company’s receipt of future milestone payments depends upon whether Ocumension HK is able to successfully complete product development and commercialization in the Territory, which requires, among other things, obtaining necessary regulatory approvals and appropriate reimbursement pricing in the various countries and jurisdictions in the Territory, a process that may take several years. The Company recognized $ 11.0 million 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 (warrant agreement), which are discussed in Note 16. |
Loan Agreements
Loan Agreements | 6 Months Ended |
Jun. 30, 2021 | |
Loan Agreements [Abstract] | |
Loan Agreements | 10. LOAN AGREEMENTS Loan Agreements with SLR Investment Corp. (formerly named Solar Capital Ltd.) As of 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. 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. 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 15th 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. 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 the three months ended June 30, 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 June 30, 2021 and December 31, 2020. Hercules Loan Agreement and Related Warrant In connection with the previous loan with Hercules Capital, Inc. (Hercules), on October 20, 2016, the Company issued a warrant to Hercules Capital, Inc. that granted Hercules the right to purchase up to 30,582 shares of the Company’s common stock at an exercise price of $ 16.35 per share. The right to exercise this warrant expires on October 20, 2021. |
Earnings (Loss) Per Share (EPS)
Earnings (Loss) Per Share (EPS) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings (Loss) Per Share (EPS) [Abstract] | |
Earnings (Loss) Per Share (EPS) | 11. EARNINGS (LOSS) PER SHARE (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. However, the Company’s preferred stockholders are not contractually obligated to share in losses. Basic EPS is computed by dividing net income or loss available to stockholders by the weighted average number of shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, 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. The Company had net income available to stockholders for the three and six months ended June 30, 2021, primarily due to the Ocumension share purchase agreement, which closed on April 14, 2021. Basic and diluted earnings per share attributable to common and participating shares of common stock for the period were as follows: Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands, except share and per share data) Net income (loss) available to stockholders $ 7,565 $ ( 2,546 ) $ 3,917 $ ( 3,744 ) Allocation of undistributed income (loss): Income (loss) attributable to common stock $ 6,989 $ ( 2,546 ) $ 3,619 $ ( 3,744 ) Income attributable to participating securities $ 576 $ — $ 298 $ — Basic shares: Weighted average common shares 6,750,415 5,030,833 6,255,668 5,005,777 Weighted average participating shares 601,504 — 601,504 — Total basic weighted average shares 7,351,919 5,030,833 6,857,172 5,005,777 Diluted shares: Weighted average common shares 6,750,415 5,030,833 6,255,668 5,005,777 Dilutive weighted average shares 11,231 — — — Total dilutive weighted common shares 6,761,646 5,030,833 6,255,668 5,005,777 Weighted average participating shares 601,504 — 601,504 — Total dilutive weighted average shares 7,363,150 5,030,833 6,857,172 5,005,777 Basic EPS $ 1.03 $ ( 0.51 ) $ 0.57 $ ( 0.75 ) Diluted EPS $ 1.03 $ ( 0.51 ) $ 0.57 $ ( 0.75 ) Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either not classified as participating or would have been anti-dilutive, were as follows: Three and Six Months Ended June 30, 2021 2020 Series A convertible preferred stock — 601,504 Series C convertible preferred stock — 676,667 Common stock warrants 30,582 119,712 Stock options 720,999 1,043,297 Total 751,581 2,441,180 |
Preferred Stock
Preferred Stock | 6 Months Ended |
Jun. 30, 2021 | |
Preferred Stock [Abstract] | |
Preferred Stock | 12. PREFERRED STOCK Series A Convertible Preferred Stock As of June 30, 2021, there were 600,000 shares of Series A Convertible Preferred Stock issued and outstanding. Series C Convertible Preferred Stock The holders of all of the then outstanding shares of Series C Preferred Stock converted them into 676,667 shares of the Company’s common stock in the third and fourth quarters of 2020. Accordingly, there were no shares of Series C Preferred Stock issued and outstanding at December 31, 2020 or June 30, 2021. |
Equity Incentive Plans
Equity Incentive Plans | 6 Months Ended |
Jun. 30, 2021 | |
Equity Incentive Plans [Abstract] | |
Equity Incentive Plans | 13. EQUITY INCENTIVE PLANS Under the Company’s 2019 Omnibus Incentive Plan (the 2019 Plan), the Compensation Committee of the Board is authorized to grant equity-based incentive awards that include stock options, restricted stock units (RSUs) and shares of restricted stock to officers, directors, employees and contractors. Equity-based awards are also outstanding under the Company’s 2010 Equity Incentive Plan, although no new awards can be granted under that plan. The Company also has an employee stock purchase plan. Stock Options During the three months ended June 30, 2021 and 2020, the Company recorded compensation expense related to stock options of approximately $ 224,000 and $ 279,000 , respectively. During the six months ended June 30, 2021 and 2020, the Company recorded compensation expense related to stock options of approximately $ 459,000 and $ 571,000 , respectively. As of June 30, 2021, the total unrecognized compensation cost related to non-vested stock options granted was $ 1,468,000 and is expected to be recognized over a weighted average period of 2.60 years. The following table presents a summary of stock option activity for the three months ended June 30, 2021 and 2020: Three Months Ended June 30, 2021 2020 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,083,124 23.73 1,036,484 30.84 Grants 26,150 9.00 27,431 6.54 Forfeitures and expirations ( 15,193 ) 24.60 ( 20,618 ) 49.07 Exercises ( 6,339 ) 6.59 — — Options outstanding at period end 1,087,742 23.46 1,043,297 29.84 Options exercisable at period end 759,434 30.42 730,712 38.14 Weighted average per share fair value of options granted during the period $ 5.99 $ 4.16 The following table presents a summary of stock option activity for the six months ended June 30, 2021 and 2020: Six Months Ended June 30, 2021 2020 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 939,379 26.72 871,472 35.46 Grants 213,300 5.51 196,281 6.72 Forfeitures ( 58,540 ) 12.16 ( 24,456 ) 44.67 Exercises ( 6,397 ) 6.59 — — Options outstanding at period end 1,087,742 23.46 1,043,297 29.84 Options exercisable at period end 759,434 30.42 730,712 38.14 Weighted average per share fair value of options granted during the period $ 3.56 $ 4.17 The following table provides additional information related to outstanding stock options as of June 30, 2021: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,087,742 23.46 6.06 years 1,110 Exercisable 759,434 30.42 4.83 years 252 Outstanding, vested and expected to vest 1,042,284 24.20 5.93 years 978 The following table provides additional information related to outstanding stock options as of December 31, 2020: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 939,379 26.72 5.92 years — Exercisable 701,725 32.46 5.02 years — Outstanding, vested and expected to vest 911,509 27.26 5.84 years — As of June 30, 2021, 1,020,701 shares remain available for grant under the 2019 Plan, which reflects the amendment of the 2019 Plan effective June 15, 2021, after stockholder approval, that increased the number of shares for which awards can be granted by 1,000,000 shares. Restricted Stock and Restricted Stock Units A summary of restricted stock and restricted stock units (RSU) transactions under the plans are as follows: Three Months Ended June 30, 2021 2020 Weighted Weighted Average Average Restricted Grant Date Restricted Grant Date Stock & RSUs Fair Value ($) Stock & RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 38,750 5.01 30,086 3.12 Grants 7,500 8.93 — — Vested units — — — — Forfeitures — — — — Restricted stock & RSUs outstanding at period end 46,250 5.65 30,086 3.12 Six Months Ended June 30, 2021 2020 Weighted Weighted Average Average Restricted Grant Date Restricted Grant Date Stock & RSUs Fair Value ($) Stock & RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 30,086 3.12 36,763 13.15 Grants 52,500 5.57 30,086 3.12 Vested units ( 25,403 ) 3.12 ( 36,763 ) 13.15 Forfeitures ( 10,933 ) 4.20 — — Restricted stock & RSUs outstanding at period end 46,250 5.65 30,086 3.12 Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation (ASC 718) was $ 16,000 and $ 21,000 for the three months ended June 30, 2021 and 2020, respectively. Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718 was $ 35,000 and $ 148,000 for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, the total unrecognized compensation cost related to restricted stock was $ 236,000 and is expected to be recognized over a weighted average period of 2.88 years. Employee Stock Purchase Plan During the three months ended June 30, 2021 and 2020, the Company recorded compensation expense related to its employee stock purchase plan of approximately $ 12,000 and $ 17,000 , respectively. During the six months ended June 30, 2021 and 2020, the Company recorded compensation expense related to its employee stock purchase plan of approximately $ 20,000 and $ 38,000 , respectively. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Taxes [Abstract] | |
Income Taxes | 14. INCOME TAXES In accordance with ASC 740, Income Taxes, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. At the end of each interim period, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. This estimate reflects, among other items, the Company’s best estimate of operating results and foreign currency exchange rates. The Company also applies the provisions for income taxes related to, among other things, accounting for uncertain tax positions and disclosure requirements. There has been no change to the Company’s policy that recognizes potential interest and penalties related to uncertain tax positions. The Company conducts business globally and, as a result, files income tax returns in the U.S. federal jurisdiction and various state and foreign jurisdictions. In the normal course of business, the Company is subject to examination by taxing authorities throughout the world. At December 31, 2020, the Company had U.S. federal NOL carry-forwards of approximately $ 131,400,000 and state NOL carry-forwards of approximately $ 96,200,000 available to reduce future taxable income. The Company’s U.S. federal NOL carry-forwards remain fully reserved as of June 30, 2021. Except for the NOLs generated after 2017, the U.S. federal NOLs not fully utilized will expire at various dates between 2029 and 2038; most state NOL carry-forwards will expire at various dates between 2021 and 2040. Under the Tax Cuts and Jobs Act of 2017, U.S. federal NOLs and some state NOLs generated after 2017 will carryforward indefinitely. As of December 31, 2020, the Company had cumulative book losses in foreign subsidiaries of $ 136,500,000 . The Company had not recorded a deferred tax asset for the excess of tax over book basis in the stock of its foreign subsidiaries. The Company intends to indefinitely reinvest in its foreign subsidiaries all undistributed earnings of 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. During the three months ended June 30, 2021, the Company recognized income in its U.K. subsidiary associated with the agreements with Ocumension Therapeutics. This income will cause the U.K. subsidiary to be taxable in 2021 and will result in local country income tax expense in the U.K. The Company has calculated its income tax expense for the three months ended June 30, 2021 and for the six months ended June 30, 2021 in accordance with ASC 740-270. The increase in the effective tax rate compared to prior periods is primarily due to the income recognized in association with the Ocumension Therapeutics agreements. |
Segment Information
Segment Information | 6 Months Ended |
Jun. 30, 2021 | |
Segment Information [Abstract] | |
Segment Information | 15. SEGMENT INFORMATION During the three months ended June 30, 2021 and 2020, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 54 % and 34 %, respectively, of the Company’s consolidated product revenues. During the six months ended June 30, 2021 and 2020, these two customers within the U.S. segment accounted for 52 % and 43 %, respectively, of the Company’s consolidated product revenues. These same two customers within the U.S. segment accounted for approximately 65 % and 67 % of the Company’s consolidated accounts receivable at June 30, 2021 and at December 31, 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. The Company’s U.S. and International segments represent the sales and marketing, general and administrative and research & development activities dedicated to the respective geographies. The Operating Cost segment primarily represents the general & 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 tables present a summary of the Company’s reporting segments for the three and six months ended June 30, 2021 and 2020: Three Months Ended June 30, 2021 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 5,787 $ 4,868 $ — $ — $ 10,655 LICENSE REVENUE — 11,048 — — 11,048 NET REVENUE 5,787 15,916 — — 21,703 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 705 ) ( 1,108 ) — — ( 1,813 ) GROSS PROFIT 5,082 14,808 — — 19,890 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 874 1,086 1,584 23 3,567 GENERAL AND ADMINISTRATIVE EXPENSES 230 471 2,486 169 3,356 SALES AND MARKETING EXPENSES 3,667 1,463 143 58 5,331 DEPRECIATION AND AMORTIZATION — — — 633 633 OPERATING EXPENSES 4,771 3,020 4,213 883 12,887 SEGMENT INCOME (LOSS) FROM OPERATIONS 311 11,788 ( 4,213 ) ( 883 ) 7,003 OTHER INCOME AND EXPENSES, NET — — — 1,202 1,202 NET INCOME BEFORE TAXES $ 8,205 Three Months Ended June 30, 2020 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 3,420 $ 6,618 $ — $ — $ 10,038 LICENSE REVENUE — — — — — NET REVENUE 3,420 6,618 — — 10,038 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 423 ) ( 1,062 ) — — ( 1,485 ) GROSS PROFIT 2,997 5,556 — — 8,553 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 748 606 407 49 1,810 GENERAL AND ADMINISTRATIVE EXPENSES 261 493 1,843 194 2,791 SALES AND MARKETING EXPENSES 3,097 1,284 110 75 4,566 DEPRECIATION AND AMORTIZATION — — — 685 685 OPERATING EXPENSES 4,106 2,383 2,360 1,003 9,852 SEGMENT INCOME (LOSS) FROM OPERATIONS ( 1,109 ) 3,173 ( 2,360 ) ( 1,003 ) ( 1,299 ) OTHER INCOME AND EXPENSES, NET — — — ( 1,242 ) ( 1,242 ) NET LOSS BEFORE TAXES $ ( 2,541 ) Six Months Ended June 30, 2021 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 11,435 $ 10,434 $ — $ — $ 21,869 LICENSE REVENUE — 11,048 — — 11,048 NET REVENUE 11,435 21,482 — — 32,917 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,456 ) ( 1,919 ) — — ( 3,375 ) GROSS PROFIT 9,979 19,563 — — 29,542 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,599 2,026 3,122 33 6,780 GENERAL AND ADMINISTRATIVE EXPENSES 470 1,058 4,882 359 6,769 SALES AND MARKETING EXPENSES 6,945 2,796 286 122 10,149 DEPRECIATION AND AMORTIZATION — — — 1,271 1,271 OPERATING EXPENSES 9,014 5,880 8,290 1,785 24,969 SEGMENT INCOME (LOSS) FROM OPERATIONS 965 13,683 ( 8,290 ) ( 1,785 ) 4,573 OTHER INCOME AND EXPENSES, NET — — — ( 16 ) ( 16 ) NET INCOME BEFORE TAXES $ 4,557 Six Months Ended June 30, 2020 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 10,487 $ 14,086 $ — $ — 24,573 LICENSE REVENUE — — — — — NET REVENUE 10,487 14,086 — — 24,573 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,182 ) ( 2,230 ) — — ( 3,412 ) GROSS PROFIT 9,305 11,856 — — 21,161 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,855 1,431 1,290 117 4,693 GENERAL AND ADMINISTRATIVE EXPENSES 521 1,042 3,744 466 5,773 SALES AND MARKETING EXPENSES 7,251 2,775 236 175 10,437 DEPRECIATION AND AMORTIZATION — — — 1,339 1,339 OPERATING EXPENSES 9,627 5,248 5,270 2,097 22,242 SEGMENT INCOME (LOSS) FROM OPERATIONS ( 322 ) 6,608 ( 5,270 ) ( 2,097 ) ( 1,081 ) OTHER INCOME AND EXPENSES, NET — — — ( 2,615 ) ( 2,615 ) NET LOSS BEFORE TAXES $ ( 3,696 ) |
Other Agreements With Ocumensio
Other Agreements With Ocumension | 6 Months Ended |
Jun. 30, 2021 | |
Other Agreements With Ocumension [Abstract] | |
Other Agreements With Ocumension | 16. OTHER AGREEMENTS WITH OCUMENSION Share Purchase Agreement On April 14, 2021, the Company entered into the 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 $ 10.0 million. 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 (a “Subsequent Financing”) 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 will not be listed on any stock exchange. |
Fair Value
Fair Value | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value [Abstract] | |
Fair Value | 17. FAIR VALUE The Company applies ASC 820, Fair Value Measurements, in determining the fair value of certain assets and liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various valuation approaches. The hierarchy of those valuation approaches is broken down into three levels based on the reliability of inputs as follows: Level 1 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment. Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include: quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, (e.g., interest rates and yield curves observable at commonly quoted intervals or current market) and contractual prices for the underlying financial instrument, as well as other relevant economic measures. Level 3 inputs are unobservable inputs for the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: June 30, 2021 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 2,062 $ — $ 2,062 Assets measured at fair value $ — $ 2,062 $ — $ 2,062 (1) The Company uses the Black-Scholes pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Changes in this value each reporting period are reported in the condensed consolidated statement of operations. |
Summary Of Significant Accoun_2
Summary Of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Summary Of Significant Accounting Policies [Abstract] | |
Reclassifications | Reclassifications Within the operating expenses section of the Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2020 as well as within the International segment (see Note 15), the Company reclassified $ 184,000 and $ 383,000 , respectively, in sales and marketing expenses associated with its country managers in Europe from general and administrative expenses to sales and marketing expenses. The Company made this reclassification to provide additional transparency of the activity being performed and to conform them to the current quarter presentation. These changes had no impact on previously reported consolidated balance sheets, net loss on our statements of operations, comprehensive loss, stockholders’ deficit or cash flows. |
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 intraperiod 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. Accounting Standards Issued but Not Yet Effective In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments - Credit Losses (Accounting Standards Codification (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. ASU 2020-04 is effective for all entities as of March 12, 2020 through December 31, 2022. The Company is currently assessing the impact of the optional guidance on the Company’s consolidated financial statements and disclosures. 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 becomes effective for the Company on January 1, 2022. The Company is currently assessing the impact of adoption of the ASU. |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases [Abstract] | |
Summary of Operating Leases Supplemental Balance Sheet Information | June 30, December 31, 2021 2020 (In thousands) NON-CURRENT ASSETS: Right of use assets, net $ 683 $ 720 Total lease assets $ 683 $ 720 CURRENT LIABILITIES: Accrued expenses $ 261 $ 405 NON-CURRENT LIABILITIES: Other non-current liabilities 488 438 Total lease liabilities $ 749 $ 843 |
Schedule of Future Minimum Operating Lease Payments | Years Ending December 31 (In thousands) 2021 (remaining) $ 204 2022 230 2023 231 2024 202 Thereafter — Total 867 Less amount representing interest ( 118 ) Present value of minimum lease payments 749 Less current portion (as a portion of accrued expenses) ( 261 ) Non-current portion (as a portion of other non-current liabilities) $ 488 |
Summary of Finance Leases Supplemental Balance Sheet Information | June 30, December 31, 2021 2020 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 600 $ 810 Total lease assets $ 600 $ 810 CURRENT LIABILITIES: Finance lease obligations $ 301 $ 209 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 309 514 Total lease liabilities $ 610 $ 723 |
Schedule of Future Minimun Finance Lease Payments | Years Ending December 31 (In thousands) 2021 (remaining) $ 174 2022 269 2023 129 Total 572 Less amount representing interest ( 70 ) Present value of minimum lease payments 502 Less current portion ( 301 ) Non-current portion $ 201 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory [Abstract] | |
Schedule of Inventory | June 30, December 31, 2021 2020 (In thousands) Component parts (1) $ 468 $ 623 Work-in-process (2) — 1,221 Finished goods 1,839 902 Total Inventory $ 2,307 $ 2,746 (1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing or stability testing as required by U.S. or EEA regulatory authorities. |
Intangible Asset (Tables)
Intangible Asset (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Intangible Asset [Abstract] | |
Future Amortization | Years Ending December 31 (In thousands) 2021 (remaining) $ 978 2022 1,940 2023 1,940 2024 1,946 2025 1,940 Thereafter 3,131 Total $ 11,875 |
Earnings (Loss) Per Sare (EPS)
Earnings (Loss) Per Sare (EPS) (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Earnings (Loss) Per Share (EPS) [Abstract] | |
Schedule of Basic and Diluted Earnings (Loss) per Share | Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (In thousands, except share and per share data) Net income (loss) available to stockholders $ 7,565 $ ( 2,546 ) $ 3,917 $ ( 3,744 ) Allocation of undistributed income (loss): Income (loss) attributable to common stock $ 6,989 $ ( 2,546 ) $ 3,619 $ ( 3,744 ) Income attributable to participating securities $ 576 $ — $ 298 $ — Basic shares: Weighted average common shares 6,750,415 5,030,833 6,255,668 5,005,777 Weighted average participating shares 601,504 — 601,504 — Total basic weighted average shares 7,351,919 5,030,833 6,857,172 5,005,777 Diluted shares: Weighted average common shares 6,750,415 5,030,833 6,255,668 5,005,777 Dilutive weighted average shares 11,231 — — — Total dilutive weighted common shares 6,761,646 5,030,833 6,255,668 5,005,777 Weighted average participating shares 601,504 — 601,504 — Total dilutive weighted average shares 7,363,150 5,030,833 6,857,172 5,005,777 Basic EPS $ 1.03 $ ( 0.51 ) $ 0.57 $ ( 0.75 ) Diluted EPS $ 1.03 $ ( 0.51 ) $ 0.57 $ ( 0.75 ) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Three and Six Months Ended June 30, 2021 2020 Series A convertible preferred stock — 601,504 Series C convertible preferred stock — 676,667 Common stock warrants 30,582 119,712 Stock options 720,999 1,043,297 Total 751,581 2,441,180 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity Incentive Plans [Abstract] | |
Summary of Stock Option Transactions | Three Months Ended June 30, 2021 2020 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,083,124 23.73 1,036,484 30.84 Grants 26,150 9.00 27,431 6.54 Forfeitures and expirations ( 15,193 ) 24.60 ( 20,618 ) 49.07 Exercises ( 6,339 ) 6.59 — — Options outstanding at period end 1,087,742 23.46 1,043,297 29.84 Options exercisable at period end 759,434 30.42 730,712 38.14 Weighted average per share fair value of options granted during the period $ 5.99 $ 4.16 The following table presents a summary of stock option activity for the six months ended June 30, 2021 and 2020: Six Months Ended June 30, 2021 2020 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 939,379 26.72 871,472 35.46 Grants 213,300 5.51 196,281 6.72 Forfeitures ( 58,540 ) 12.16 ( 24,456 ) 44.67 Exercises ( 6,397 ) 6.59 — — Options outstanding at period end 1,087,742 23.46 1,043,297 29.84 Options exercisable at period end 759,434 30.42 730,712 38.14 Weighted average per share fair value of options granted during the period $ 3.56 $ 4.17 |
Summary of Additional Stock Option Transactions | The following table provides additional information related to outstanding stock options as of June 30, 2021: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,087,742 23.46 6.06 years 1,110 Exercisable 759,434 30.42 4.83 years 252 Outstanding, vested and expected to vest 1,042,284 24.20 5.93 years 978 The following table provides additional information related to outstanding stock options as of December 31, 2020: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 939,379 26.72 5.92 years — Exercisable 701,725 32.46 5.02 years — Outstanding, vested and expected to vest 911,509 27.26 5.84 years — |
Summary of Restricted Stock and Restricted Stock Unit Transactions | A summary of restricted stock and restricted stock units (RSU) transactions under the plans are as follows: Three Months Ended June 30, 2021 2020 Weighted Weighted Average Average Restricted Grant Date Restricted Grant Date Stock & RSUs Fair Value ($) Stock & RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 38,750 5.01 30,086 3.12 Grants 7,500 8.93 — — Vested units — — — — Forfeitures — — — — Restricted stock & RSUs outstanding at period end 46,250 5.65 30,086 3.12 Six Months Ended June 30, 2021 2020 Weighted Weighted Average Average Restricted Grant Date Restricted Grant Date Stock & RSUs Fair Value ($) Stock & RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 30,086 3.12 36,763 13.15 Grants 52,500 5.57 30,086 3.12 Vested units ( 25,403 ) 3.12 ( 36,763 ) 13.15 Forfeitures ( 10,933 ) 4.20 — — Restricted stock & RSUs outstanding at period end 46,250 5.65 30,086 3.12 |
Segment Information (Tables)
Segment Information (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Segment Information [Abstract] | |
Summary of Operations by Segment | The following tables present a summary of the Company’s reporting segments for the three and six months ended June 30, 2021 and 2020: Three Months Ended June 30, 2021 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 5,787 $ 4,868 $ — $ — $ 10,655 LICENSE REVENUE — 11,048 — — 11,048 NET REVENUE 5,787 15,916 — — 21,703 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 705 ) ( 1,108 ) — — ( 1,813 ) GROSS PROFIT 5,082 14,808 — — 19,890 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 874 1,086 1,584 23 3,567 GENERAL AND ADMINISTRATIVE EXPENSES 230 471 2,486 169 3,356 SALES AND MARKETING EXPENSES 3,667 1,463 143 58 5,331 DEPRECIATION AND AMORTIZATION — — — 633 633 OPERATING EXPENSES 4,771 3,020 4,213 883 12,887 SEGMENT INCOME (LOSS) FROM OPERATIONS 311 11,788 ( 4,213 ) ( 883 ) 7,003 OTHER INCOME AND EXPENSES, NET — — — 1,202 1,202 NET INCOME BEFORE TAXES $ 8,205 Three Months Ended June 30, 2020 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 3,420 $ 6,618 $ — $ — $ 10,038 LICENSE REVENUE — — — — — NET REVENUE 3,420 6,618 — — 10,038 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 423 ) ( 1,062 ) — — ( 1,485 ) GROSS PROFIT 2,997 5,556 — — 8,553 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 748 606 407 49 1,810 GENERAL AND ADMINISTRATIVE EXPENSES 261 493 1,843 194 2,791 SALES AND MARKETING EXPENSES 3,097 1,284 110 75 4,566 DEPRECIATION AND AMORTIZATION — — — 685 685 OPERATING EXPENSES 4,106 2,383 2,360 1,003 9,852 SEGMENT INCOME (LOSS) FROM OPERATIONS ( 1,109 ) 3,173 ( 2,360 ) ( 1,003 ) ( 1,299 ) OTHER INCOME AND EXPENSES, NET — — — ( 1,242 ) ( 1,242 ) NET LOSS BEFORE TAXES $ ( 2,541 ) Six Months Ended June 30, 2021 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 11,435 $ 10,434 $ — $ — $ 21,869 LICENSE REVENUE — 11,048 — — 11,048 NET REVENUE 11,435 21,482 — — 32,917 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,456 ) ( 1,919 ) — — ( 3,375 ) GROSS PROFIT 9,979 19,563 — — 29,542 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,599 2,026 3,122 33 6,780 GENERAL AND ADMINISTRATIVE EXPENSES 470 1,058 4,882 359 6,769 SALES AND MARKETING EXPENSES 6,945 2,796 286 122 10,149 DEPRECIATION AND AMORTIZATION — — — 1,271 1,271 OPERATING EXPENSES 9,014 5,880 8,290 1,785 24,969 SEGMENT INCOME (LOSS) FROM OPERATIONS 965 13,683 ( 8,290 ) ( 1,785 ) 4,573 OTHER INCOME AND EXPENSES, NET — — — ( 16 ) ( 16 ) NET INCOME BEFORE TAXES $ 4,557 Six Months Ended June 30, 2020 U.S. International Operating Cost Other Consolidated (In thousands) REVENUE: PRODUCT REVENUE, NET $ 10,487 $ 14,086 $ — $ — 24,573 LICENSE REVENUE — — — — — NET REVENUE 10,487 14,086 — — 24,573 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,182 ) ( 2,230 ) — — ( 3,412 ) GROSS PROFIT 9,305 11,856 — — 21,161 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,855 1,431 1,290 117 4,693 GENERAL AND ADMINISTRATIVE EXPENSES 521 1,042 3,744 466 5,773 SALES AND MARKETING EXPENSES 7,251 2,775 236 175 10,437 DEPRECIATION AND AMORTIZATION — — — 1,339 1,339 OPERATING EXPENSES 9,627 5,248 5,270 2,097 22,242 SEGMENT INCOME (LOSS) FROM OPERATIONS ( 322 ) 6,608 ( 5,270 ) ( 2,097 ) ( 1,081 ) OTHER INCOME AND EXPENSES, NET — — — ( 2,615 ) ( 2,615 ) NET LOSS BEFORE TAXES $ ( 3,696 ) |
Fair Value (Tables)
Fair Value (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value [Abstract] | |
Fair Value Of Assets And Liabilities | The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: June 30, 2021 Level 1 Level 2 Level 3 Total (In thousands) Assets: Warrant asset (1) $ — $ 2,062 $ — $ 2,062 Assets measured at fair value $ — $ 2,062 $ — $ 2,062 (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 | 6 Months Ended |
Jun. 30, 2021countryg | |
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 |
Size of intravitreal injection approved | g | 0.19 |
Summary Of Significant Accoun_3
Summary Of Significant Accounting Policies (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
General and administrative expenses | $ 3,356 | $ 2,791 | $ 6,769 | $ 5,773 | ||
Sales and marketing expenses | 5,331 | 4,566 | 10,149 | 10,437 | ||
Cash and restricted cash | 24,815 | 13,527 | 24,815 | 13,527 | $ 11,242 | $ 9,459 |
Revision of Prior Period, Reclassification, Adjustment [Member] | ||||||
General and administrative expenses | (184) | (383) | ||||
Sales and marketing expenses | 184 | 383 | ||||
United States Segment | ||||||
General and administrative expenses | 230 | 261 | 470 | 521 | ||
Sales and marketing expenses | 3,667 | 3,097 | 6,945 | 7,251 | ||
International Segment | ||||||
General and administrative expenses | 471 | 493 | 1,058 | 1,042 | ||
Sales and marketing expenses | $ 1,463 | $ 1,284 | $ 2,796 | $ 2,775 |
Revenue Recognition (Narrative)
Revenue Recognition (Narrative) (Details) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue Recognition [Abstract] | |
Period before expiration date returns are accepted | 3 months |
Period after expiration date returns are accepted | 1 year |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Lessee, Lease, Description [Line Items] | ||||
Operating lease cost | $ 118,000 | $ 96,000 | $ 236,000 | $ 223,000 |
Cash paid for leases | 298,000 | 216,000 | ||
Right-of-use asset obtained in exchange for operating lease liability | $ 157,000 | 0 | ||
Weighted average remaining lease term | 3 years 1 month 6 days | 3 years 1 month 6 days | ||
Weighted average discount rate, leases | 9.96% | 9.96% | ||
Depreciation expense property and equipment under finance leases | $ 104,000 | 112,000 | $ 209,000 | 193,000 |
Finance lease interest expense | $ 15,000 | $ 13,000 | 32,000 | 19,000 |
Cash paid for finance leases | 195,000 | |||
Property and equipment acquired under finance leases | $ 0 | $ 495,000 | ||
Finance lease, weighted average remaining term | 1 year 7 months 6 days | 1 year 7 months 6 days | ||
Finance lease, weighted average discount rate | 9.30% | 9.30% | ||
Minimum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease renewal term | 1 year | 1 year | ||
Maximum | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease renewal term | 7 years | 7 years |
Leases (Summary of Operating Le
Leases (Summary of Operating Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
NON-CURRENT ASSETS: | ||
Operating lease, right-of-use asset | $ 683 | $ 720 |
CURRENT LIABILITIES: | ||
Accrued expenses | 261 | 405 |
NON-CURRENT LIABILITIES: | ||
Other non-current liabilities | 488 | 438 |
Present value of minimum lease payments | $ 749 | $ 843 |
Leases (Schedule of Future Mini
Leases (Schedule of Future Minimum Operating Lease Payments) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
2021 (remaining) | $ 204 | |
2022 | 230 | |
2023 | 231 | |
2024 | 202 | |
Thereafter | ||
Total | 867 | |
Less amount representing interest | (118) | |
Present value of minimum lease payments | 749 | $ 843 |
Less current portion (as a portion of accrued expenses) | (261) | (405) |
Non-current portion (as a portion of other non-current liabilities) | $ 488 | $ 438 |
Leases (Summary of Finance Leas
Leases (Summary of Finance Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | $ 600 | $ 810 |
Total lease assets | 600 | 810 |
CURRENT LIABILITIES: | ||
Finance lease obligations | 301 | 209 |
NON-CURRENT LIABILITIES: | ||
Finance lease obligations — less current portion | 309 | 514 |
Present value of minimum lease payments | $ 610 | $ 723 |
Leases (Schedule of Future Mi_2
Leases (Schedule of Future Minimun Finance Lease Payments) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Present value of minimum lease payments | $ 610 | $ 723 |
Less current portion | (301) | (209) |
Non-current portion | 309 | $ 514 |
Property, Plant and Equipment [Member] | ||
2021 (remaining) | 174 | |
2022 | 269 | |
2023 | 129 | |
Total | 572 | |
Less amount representing interest | (70) | |
Present value of minimum lease payments | 502 | |
Less current portion | (301) | |
Non-current portion | $ 201 |
Going Concern (Narrative) (Deta
Going Concern (Narrative) (Details) | Apr. 14, 2021USD ($)item | Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | |||||
Accumulated deficit | $ 388,992,000 | $ 392,909,000 | |||
Cash and restricted cash | $ 24,815,000 | $ 11,242,000 | $ 13,527,000 | $ 9,459,000 | |
2019 Solar Loan Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | $ 45,000,000 | ||||
Ocumension [Member] | |||||
Debt Instrument [Line Items] | |||||
Number of investment agreements | item | 4 | ||||
Proceeds from related party | $ 20,000,000 |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory | ||
Component parts | $ 468 | $ 623 |
Work-in-process | 1,221 | |
Finished goods | 1,839 | 902 |
Total inventory | $ 2,307 | $ 2,746 |
Intangible Asset (Narrative) (D
Intangible Asset (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2014 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Amortization of intangible assets | $ 963 | $ 967 | ||||
Net intangible assets | $ 11,875 | 11,875 | $ 12,838 | |||
License | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Gross intangible assets | 25,000 | $ 25,000 | ||||
Useful life (in years) | 13 years | |||||
Amortization of intangible assets | 484 | $ 484 | ||||
Net intangible assets | $ 11,875 | $ 11,875 | $ 12,838 | |||
pSivida | ||||||
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 | Jun. 30, 2021 | Dec. 31, 2020 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Total | $ 11,875 | $ 12,838 |
License | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2021 | 978 | |
2022 | 1,940 | |
2023 | 1,940 | |
2024 | 1,946 | |
2025 | 1,940 | |
Thereafter | 3,131 | |
Total | $ 11,875 | $ 12,838 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Aug. 01, 2017 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Royalty expense | $ 401,000 | $ 982,000 | ||||
Collaborative Arrangement, Co-promotion | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Collaborative arrangement, royalty payable on net revenue, percentage | 5.20% | 4.00% | 5.20% | 4.00% | ||
Collaborative arrangement, reduction in royalty payable, percent | 6.00% | 6.00% | 6.00% | |||
Collaborative arrangement, royalty payable on net revenue over threshold, percentage | 2.00% | |||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000,000 | |||||
Royalty expense | $ 1,021,000 | 1,605,000 | ||||
Accrued royalty expense | 1,021,000 | 1,021,000 | ||||
pSivida | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | |||||
pSivida | Maximum | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Recoverable amount to offset future royalty payments | 7,707,000 | 7,707,000 | $ 15,000,000 | |||
Ocumension [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Payment from related party | 10,000,000 | |||||
Revenue from related party | $ 11,000,000 | |||||
License agreement, shares purchased | 1,000,000 | |||||
License agreement, share purchase duration | 4 years | |||||
Deferred revenue related party | $ 300,000 | $ 300,000 | ||||
Ocumension [Member] | Milestone One [Member] | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Payment from related party | $ 89,000,000 |
Loan Agreements (Solar Capital
Loan Agreements (Solar Capital Loan Agreement) (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2019 | Feb. 21, 2020 | Jan. 05, 2018 | |
Debt Instrument [Line Items] | |||||||
Net revenue | $ 21,703 | $ 10,038 | $ 32,917 | $ 24,573 | |||
2018 Solar Term Loan | Solar Capital Ltd. | |||||||
Debt Instrument [Line Items] | |||||||
Line of credit facility, maximum borrowing capacity | $ 45,000 | ||||||
2019 Solar Loan Agreement | Solar Capital Ltd. | |||||||
Debt Instrument [Line Items] | |||||||
Line of credit facility, maximum borrowing capacity | 45,000 | $ 40,000,000,000 | |||||
Line of credit | 42,500 | $ 2,500 | |||||
Debt instrument prepayment fee paid | 2,300 | ||||||
Debt instrument repayment fee amount, paid | $ 2,200 | ||||||
Second Amendment 2019 Solar Capital Loan Agreement [Member] | Solar Capital Ltd. | |||||||
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 | Solar Capital Ltd. | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, exit fee agreement, term | 10 years | ||||||
Debt instrument, exit fee | $ 2,000 | ||||||
2019 Exit Fee Agreement [Member] | 2019 Solar Loan Agreement | Solar Capital Ltd. | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, exit fee agreement, term | 10 years | ||||||
Debt instrument, exit fee | $ 675 |
Loan Agreements (Modification o
Loan Agreements (Modification of Debt) (Narrative) (Details) - Solar Capital Ltd. - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Jun. 30, 2021 | |
2018 Loan Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Debt instrument repayment fee amount, paid | $ 1,800 | |
Debt instrument prepayment fee paid | 400 | |
2019 Solar Loan Agreement | ||
Debt Instrument [Line Items] | ||
Deferred financing costs | $ 427 | |
Costs incurred with third parties | 76 | |
Debt instrument repayment fee amount, paid | 2,200 | |
Debt instrument prepayment fee paid | $ 2,300 |
Loan Agreements (Paycheck Prote
Loan Agreements (Paycheck Protection Program) (Narrative) (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Apr. 22, 2020 | |
Debt Instrument [Line Items] | |||
Gain on extinguishment of debt | $ 1,792,000 | $ 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 |
Loan Agreements (Solar Capita_2
Loan Agreements (Solar Capital 2019 Loan Agreement) (Narrative) (Details) - Solar Capital Ltd. - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Dec. 31, 2019 | Feb. 21, 2020 | Jan. 05, 2018 | |
2019 Solar Loan Agreement | ||||
Line of Credit Facility [Line Items] | ||||
Line of credit maximum borrowing capacity | $ 45,000 | $ 40,000,000,000 | ||
Line of credit | 42,500 | $ 2,500 | ||
Debt instrument repayment fee amount, paid | 2,200 | |||
Debt instrument prepayment fee paid | 2,300 | |||
2018 Solar Term Loan | ||||
Line of Credit Facility [Line Items] | ||||
Line of credit maximum borrowing capacity | $ 45,000 | |||
2018 Exit Fee Agreement | 2018 Solar Term Loan | ||||
Line of Credit Facility [Line Items] | ||||
Debt instrument, exit fee | $ 2,000 |
Loan Agreements (Hercules Loan
Loan Agreements (Hercules Loan Agreement And Related Warrant) (Narrative) (Details) - Hercules Technology Growth Capital, Inc. - Warrants 2016 [Member] | Jun. 30, 2021$ / sharesshares |
Debt Instrument [Line Items] | |
Class of warrant or right, number of securities called by warrants or rights (in shares) | shares | 30,582 |
Class of warrant or right, exercise price of warrants or rights (usd per share) | $ / shares | $ 16.35 |
Earnings (Loss) Per Share (EP_2
Earnings (Loss) Per Share (EPS) (Schedule of Basic and Diluted Earnings (Loss) per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Earnings (Loss) Per Share (EPS) [Abstract] | ||||
Net income (loss) available to stockholders | $ 7,565 | $ (2,546) | $ 3,917 | $ (3,744) |
Allocation of undistributed income (loss): | ||||
Income (loss) attributable to common stock | 6,989 | $ (2,546) | 3,619 | $ (3,744) |
Income attributable to participating securities | $ 576 | $ 298 | ||
Basic shares: | ||||
Weighted average common shares (in shares) | 6,750,415 | 5,030,833 | 6,255,668 | 5,005,777 |
Weighted average participating shares (in shares) | 601,504 | 601,504 | ||
Total basic weighted average shares (in shares) | 7,351,919 | 5,030,833 | 6,857,172 | 5,005,777 |
Diluted shares: | ||||
Weighted average common shares | 6,750,415 | 5,030,833 | 6,255,668 | 5,005,777 |
Dilutive weighted average shares | 11,231 | |||
Total dilutive weighted average shares (in shares) | 6,761,646 | 5,030,833 | 6,255,668 | 5,005,777 |
Weighted average participating shares (in shares) | 601,504 | 601,504 | ||
Total dilutive weighted common shares (in shares) | 7,363,150 | 5,030,833 | 6,857,172 | 5,005,777 |
Basic EPS (USD per share) | $ 1.03 | $ (0.51) | $ 0.57 | $ (0.75) |
Diluted EPS (USD per share) | $ 1.03 | $ (0.51) | $ 0.57 | $ (0.75) |
Earnings (Loss) Per Share (EP_3
Earnings (Loss) Per Share (EPS) (Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share) (Details) - shares | 3 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 751,581 | 2,441,180 |
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 | |
Series C 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) | 676,667 | |
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 | 119,712 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 720,999 | 1,043,297 |
Preferred Stock (Narrative) (De
Preferred Stock (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Conversion of Stock [Line Items] | ||||
Issuance of preferred stock | $ 9,960 | $ 1 | $ 10 | |
Series C convertible preferred stock | ||||
Conversion of Stock [Line Items] | ||||
Preferred stock, shares issued (in shares) | 0 | 0 | ||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||
Conversion shares | 676,667 | |||
Series A convertible preferred stock | ||||
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 |
Equity Incentive Plans (Narrati
Equity Incentive Plans (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Jun. 15, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted average contractual term | 4 years 9 months 29 days | 5 years 7 days | ||||
Exercise of stock options (in shares) | 6,339 | 6,397 | ||||
Share-based compensation expense | $ 514 | $ 757 | ||||
Stock options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Weighted average contractual term | 2 years 7 months 6 days | |||||
Share-based compensation not yet recognized | $ 1,468 | $ 1,468 | ||||
Share-based compensation expense | $ 224 | $ 279 | $ 459 | 571 | ||
Omnibus Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares available for grant (in shares) | 1,020,701 | 1,020,701 | 1,000,000 | |||
Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | $ 12 | 17 | $ 20 | 38 | ||
Restricted Stock and RSUs | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation expense | 16 | $ 21 | 35 | $ 148 | ||
Restricted Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Unrecognized share based compensation expense | $ 236 | $ 236 | ||||
Weighted average period | 2 years 10 months 17 days |
Equity Incentive Plans (Summary
Equity Incentive Plans (Summary of Stock Option Transactions) (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Options | ||||||
Options outstanding at beginning of period (in shares) | 1,083,124 | 939,379 | 1,036,484 | 939,379 | 871,472 | |
Grants (in shares) | 26,150 | 27,431 | 213,300 | 196,281 | ||
Forfeitures and expirations (in shares) | (15,193) | (20,618) | (58,540) | (24,456) | ||
Exercises (in shares) | (6,339) | (6,397) | ||||
Options outstanding at year end (in shares) | 1,087,742 | 1,083,124 | 1,043,297 | 1,087,742 | 1,043,297 | |
Options exercisable at year end (in shares) | 759,434 | 730,712 | 759,434 | 730,712 | 701,725 | |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 5.99 | $ 4.16 | $ 3.56 | $ 4.17 | ||
Weighted Average Exercise Price ($) | ||||||
Options outstanding at beginning of period (usd per share) | 23.73 | $ 26.72 | 30.84 | 26.72 | 35.46 | |
Grants (usd per share) | 9 | 6.54 | 5.51 | 6.72 | ||
Forfeitures and expirations (usd per share) | 24.60 | 49.07 | 12.16 | 44.67 | ||
Exercises (usd per share) | 6.59 | 6.59 | ||||
Options outstanding at year end (usd per share) | 23.46 | $ 23.73 | 29.84 | 23.46 | 29.84 | |
Options exercisable at year end (usd per share) | $ 30.42 | $ 38.14 | $ 30.42 | $ 38.14 | $ 32.46 |
Equity Incentive Plans (Summa_2
Equity Incentive Plans (Summary of Additional Stock Option Transactions) (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021 | Dec. 31, 2020 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | |
Outstanding Stock Options | ||||||
Outstanding, shares (in shares) | 1,087,742 | 939,379 | 1,083,124 | 1,043,297 | 1,036,484 | 871,472 |
Outstanding, weighted average exercise price (usd per share) | $ 23.46 | $ 26.72 | $ 23.73 | $ 29.84 | $ 30.84 | $ 35.46 |
Outstanding, weighted average remaining contractual term | 6 years 21 days | 5 years 11 months 1 day | ||||
Outstanding, aggregate intrinsic value | $ 1,110 | |||||
Exercisable Stock Options | ||||||
Exercisable, shares (in shares) | 759,434 | 701,725 | 730,712 | |||
Exercisable, weighted average exercise price (usd per share) | $ 30.42 | $ 32.46 | $ 38.14 | |||
Exercisable, weighted average remaining contractual term | 4 years 9 months 29 days | 5 years 7 days | ||||
Exercisable, aggregate intrinsic value | $ 252 | |||||
Exercisable and expected to vest | ||||||
Outstanding, vested and expected to vest, shares (in shares) | 1,042,284 | 911,509 | ||||
Outstanding, vested and expected to vest, weighted average exercise price (usd per share) | $ 24.20 | $ 27.26 | ||||
Outstanding, vested and expected to vest, weighted average remaining contractual term | 5 years 11 months 4 days | 5 years 10 months 2 days | ||||
Outstanding, vested and expected to vest, aggregate intrinsic value | $ 978 |
Equity Incentive Plans (Summa_3
Equity Incentive Plans (Summary of Restricted Stock and Restricted Stock Unit Transactions) (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Restricted Stock & RSUs | ||||
Restricted stock units & RSUs outstanding at beginning of period (in shares) | 38,750 | 30,086 | ||
Grants (in shares) | 7,500 | 0 | ||
Vested units (in shares) | 0 | 0 | ||
Forfeitures (in shares) | 0 | 0 | ||
Restricted stock units outstanding at year end (in shares) | 46,250 | 30,086 | 46,250 | 30,086 |
Weighted Average Grant Date Fair Value ($) | ||||
Restricted stock units outstanding at beginning of period (usd per share) | $ 5.01 | $ 3.12 | ||
Grants (usd per share) | 8.93 | 0 | ||
Vested units (usd per share) | 0 | 0 | ||
Forfeitures (usd per share) | 0 | 0 | ||
Restricted stock units & RSUs outstanding at year end (usd per share) | $ 5.65 | $ 3.12 | $ 5.65 | $ 3.12 |
Restricted Stock and RSUs | ||||
Restricted Stock & RSUs | ||||
Restricted stock units & RSUs outstanding at beginning of period (in shares) | 30,086 | 36,763 | ||
Grants (in shares) | 52,500 | 30,086 | ||
Vested units (in shares) | (25,403) | (36,763) | ||
Forfeitures (in shares) | (10,933) | |||
Restricted stock units outstanding at year end (in shares) | 46,250 | 30,086 | 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) | 5.57 | 3.12 | ||
Vested units (usd per share) | 3.12 | 13.15 | ||
Forfeitures (usd per share) | 4.20 | |||
Restricted stock units & RSUs outstanding at year end (usd per share) | $ 5.65 | $ 3.12 | $ 5.65 | $ 3.12 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Operating Loss Carryforwards [Line Items] | |
Cumulative book losses in foreign subsidiaries | $ (136,500) |
Federal [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry-forwards | 131,400 |
State [Member] | |
Operating Loss Carryforwards [Line Items] | |
Net operating loss carry-forwards | $ 96,200 |
Segment Information (Summary of
Segment Information (Summary of Operations by Segment) (Details) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($)customer | Jun. 30, 2020USD ($) | Dec. 31, 2020customer | |
Segment Reporting Information [Line Items] | |||||
NET REVENUE | $ 21,703 | $ 10,038 | $ 32,917 | $ 24,573 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,813) | (1,485) | (3,375) | (3,412) | |
GROSS PROFIT | 19,890 | 8,553 | 29,542 | 21,161 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,567 | 1,810 | 6,780 | 4,693 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,356 | 2,791 | 6,769 | 5,773 | |
SALES AND MARKETING EXPENSES | 5,331 | 4,566 | 10,149 | 10,437 | |
DEPRECIATION AND AMORTIZATION | 633 | 685 | 1,271 | 1,339 | |
OPERATING EXPENSES | 12,887 | 9,852 | 24,969 | 22,242 | |
INCOME (LOSS) FROM OPERATIONS | 7,003 | (1,299) | 4,573 | (1,081) | |
OTHER INCOME AND EXPENSES, NET | 1,202 | (1,242) | (16) | (2,615) | |
NET INCOME (LOSS) BEFORE TAXES | 8,205 | (2,541) | 4,557 | (3,696) | |
United States Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | 5,787 | 3,420 | 11,435 | 10,487 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (705) | (423) | (1,456) | (1,182) | |
GROSS PROFIT | 5,082 | 2,997 | 9,979 | 9,305 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 874 | 748 | 1,599 | 1,855 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 230 | 261 | 470 | 521 | |
SALES AND MARKETING EXPENSES | 3,667 | 3,097 | 6,945 | 7,251 | |
OPERATING EXPENSES | 4,771 | 4,106 | 9,014 | 9,627 | |
INCOME (LOSS) FROM OPERATIONS | $ 311 | $ (1,109) | $ 965 | $ (322) | |
United States Segment | Customer Concentration Risk | Sales | |||||
Segment Reporting Information [Line Items] | |||||
Number of customers | customer | 2 | ||||
Concentration risk percentage | 54.00% | 34.00% | 52.00% | 43.00% | |
United States Segment | Customer Concentration Risk | Accounts Receivable | |||||
Segment Reporting Information [Line Items] | |||||
Number of customers | customer | 2 | 2 | |||
Concentration risk percentage | 65.00% | 67.00% | |||
International Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | $ 15,916 | $ 6,618 | $ 21,482 | $ 14,086 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,108) | (1,062) | (1,919) | (2,230) | |
GROSS PROFIT | 14,808 | 5,556 | 19,563 | 11,856 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,086 | 606 | 2,026 | 1,431 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 471 | 493 | 1,058 | 1,042 | |
SALES AND MARKETING EXPENSES | 1,463 | 1,284 | 2,796 | 2,775 | |
OPERATING EXPENSES | 3,020 | 2,383 | 5,880 | 5,248 | |
INCOME (LOSS) FROM OPERATIONS | 11,788 | 3,173 | 13,683 | 6,608 | |
Operating Cost | |||||
Segment Reporting Information [Line Items] | |||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,584 | 407 | 3,122 | 1,290 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 2,486 | 1,843 | 4,882 | 3,744 | |
SALES AND MARKETING EXPENSES | 143 | 110 | 286 | 236 | |
OPERATING EXPENSES | 4,213 | 2,360 | 8,290 | 5,270 | |
INCOME (LOSS) FROM OPERATIONS | (4,213) | (2,360) | (8,290) | (5,270) | |
Other Segments | |||||
Segment Reporting Information [Line Items] | |||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 23 | 49 | 33 | 117 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 169 | 194 | 359 | 466 | |
SALES AND MARKETING EXPENSES | 58 | 75 | 122 | 175 | |
DEPRECIATION AND AMORTIZATION | 633 | 685 | 1,271 | 1,339 | |
OPERATING EXPENSES | 883 | 1,003 | 1,785 | 2,097 | |
INCOME (LOSS) FROM OPERATIONS | (883) | (1,003) | (1,785) | (2,097) | |
OTHER INCOME AND EXPENSES, NET | 1,202 | (1,242) | (16) | (2,615) | |
Product [Member] | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | 10,655 | 10,038 | 21,869 | 24,573 | |
Product [Member] | United States Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | 5,787 | 3,420 | 11,435 | 10,487 | |
Product [Member] | International Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | 4,868 | $ 6,618 | 10,434 | $ 14,086 | |
License [Member] | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | 11,048 | 11,048 | |||
License [Member] | International Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | $ 11,048 | $ 11,048 |
Other Agreements With Ocumens_2
Other Agreements With Ocumension (Narrative) (Details) | Apr. 14, 2021USD ($)item | Jun. 30, 2021$ / shares | Dec. 31, 2020$ / shares | Apr. 22, 2020USD ($) | Dec. 31, 2019USD ($) |
Related Party Transaction [Line Items] | |||||
Common stock, par value (usd per share) | $ / shares | $ 0.01 | $ 0.01 | |||
Ocumension [Member] | |||||
Related Party Transaction [Line Items] | |||||
Number of investment agreements | item | 4 | ||||
Partnership agreement, gross proceeds from transaction | $ 10,000,000 | ||||
2019 Solar Loan Agreement | |||||
Related Party Transaction [Line Items] | |||||
Debt instrument, face amount | $ 45,000,000 | ||||
PPP Loan [Member] | |||||
Related Party Transaction [Line Items] | |||||
Debt instrument, face amount | $ 1,778,000 |
Fair Value (Fair Value Of Asset
Fair Value (Fair Value Of Assets And Liabilities) (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Warrant asset | $ 2,062 |
Assets measured at fair value | 2,062 |
Fair Value, Inputs, Level 2 [Member] | Fair Value, Recurring [Member] | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Warrant asset | 2,062 |
Assets measured at fair value | $ 2,062 |