Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 29, 2020 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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, $0.01 par value per share | |
Trading Symbol | ALIM | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Smaller Reporting Company | true | |
Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity common stock, shares outstanding (in shares) | 5,131,744 | |
Entity Central Index Key | 0001267602 | |
Amendment Flag | false | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2020 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 11,254 | $ 9,426 |
Restricted cash | 32 | 33 |
Accounts receivable, net | 15,628 | 19,331 |
Prepaid expenses and other current assets | 3,177 | 2,565 |
Inventory (Note 7) | 2,522 | 1,390 |
Total current assets | 32,613 | 32,745 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | 1,582 | 940 |
Right of use assets, net | 791 | 1,107 |
Intangible asset, net (Note 8) | 13,327 | 14,783 |
Deferred tax asset | 767 | 734 |
TOTAL ASSETS | 49,080 | 50,309 |
CURRENT LIABILITIES: | ||
Accounts payable | 5,356 | 7,077 |
Accrued expenses | 3,475 | 4,716 |
Notes payable | 1,185 | |
Finance lease obligations | 219 | 255 |
Total current liabilities | 10,235 | 12,048 |
NON-CURRENT LIABILITIES: | ||
Note payable, net of discount (Note 10) | 42,459 | 38,658 |
Finance lease obligations — less current portion | 452 | 94 |
Other non-current liabilities | 3,567 | 3,954 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS’ DEFICIT: | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 5,131,744 shares issued and outstanding at September 30, 2020 and 4,965,949 shares issued and outstanding at December 31, 2019 | 51 | 50 |
Additional paid-in capital | 352,728 | 350,117 |
Common stock warrants | 3,707 | 3,707 |
Accumulated deficit | (391,932) | (387,570) |
Accumulated other comprehensive loss | (888) | (1,093) |
TOTAL STOCKHOLDERS’ DEFICIT | (7,633) | (4,445) |
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | 49,080 | 50,309 |
Series A convertible preferred stock | ||
STOCKHOLDERS’ DEFICIT: | ||
Preferred stock | 19,227 | 19,227 |
Series C convertible preferred stock | ||
STOCKHOLDERS’ DEFICIT: | ||
Preferred stock | $ 9,474 | $ 11,117 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
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) | 5,131,744 | 4,965,949 |
Common stock, shares outstanding (in shares) | 5,131,744 | 4,965,949 |
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 |
Series C convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 10,150 | 10,150 |
Preferred stock, shares issued (in shares) | 8,650.033 | 10,150 |
Preferred stock, shares outstanding (in shares) | 8,650.033 | 10,150 |
Preferred stock, liquidation preference | $ 8,650 | $ 10,150 |
Condensed Consolidated Statemen
Condensed Consolidated Statements Of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
NET REVENUE | $ 12,473 | $ 12,850 | $ 37,046 | $ 36,595 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,537) | (1,579) | (4,949) | (4,353) |
GROSS PROFIT | 10,936 | 11,271 | 32,097 | 32,242 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 2,469 | 2,761 | 7,162 | 8,322 |
GENERAL AND ADMINISTRATIVE EXPENSES | 2,619 | 3,121 | 8,775 | 10,189 |
SALES AND MARKETING EXPENSES | 4,764 | 6,437 | 14,818 | 18,458 |
DEPRECIATION AND AMORTIZATION | 677 | 668 | 2,016 | 1,974 |
OPERATING EXPENSES | 10,529 | 12,987 | 32,771 | 38,943 |
NET INCOME (LOSS) FROM OPERATIONS | 407 | (1,716) | (674) | (6,701) |
INTEREST EXPENSE AND OTHER | (1,285) | (1,232) | (3,928) | (3,696) |
UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET | 267 | (115) | 295 | (135) |
NET LOSS BEFORE TAXES | (611) | (3,063) | (4,307) | (10,532) |
PROVISION FOR TAXES | (7) | (77) | (55) | (409) |
NET LOSS | $ (618) | $ (3,140) | $ (4,362) | $ (10,941) |
NET (LOSS) INCOME PER COMMON SHARE — Basic and diluted (in dollars per share) | $ (0.12) | $ (0.66) | $ (0.87) | $ (2.31) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING — Basic and diluted (in shares) | 5,068,701 | 4,733,484 | 5,026,905 | 4,727,472 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements Of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
NET LOSS | $ (618) | $ (3,140) | $ (4,362) | $ (10,941) |
OTHER COMPREHENSIVE INCOME (LOSS) | ||||
Foreign currency translation adjustments | 198 | (165) | 205 | (193) |
TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | 198 | (165) | 205 | (193) |
COMPREHENSIVE LOSS | $ (420) | $ (3,305) | $ (4,157) | $ (11,134) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements Of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (4,362,000) | $ (10,941,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,016,000 | 1,974,000 |
Unrealized foreign currency transaction (gain) loss | (295,000) | 135,000 |
Amortization of debt discount | 727,000 | 626,000 |
Stock-based compensation expense | 1,074,000 | 1,903,000 |
Changes in assets and liabilities: | ||
Accounts receivable | 3,942,000 | 663,000 |
Prepaid expenses and other current assets | (301,000) | (451,000) |
Inventory | (1,104,000) | 726,000 |
Accounts payable | (1,906,000) | 497,000 |
Accrued expenses and other current liabilities | (1,310,000) | (89,000) |
Other long-term liabilities | (411,000) | 383,000 |
Net cash used in operating activities | (1,930,000) | (4,574,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (535,000) | (150,000) |
Net cash used in investing activities | (535,000) | (150,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock | 10,000 | 34,000 |
Issuance of debt | 4,278,000 | |
Payment of debt costs | (19,000) | |
Payment of finance lease obligations | (341,000) | (234,000) |
Net cash provided by (used in) financing activities | 3,928,000 | (200,000) |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 364,000 | (217,000) |
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 1,827,000 | (5,141,000) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period | 9,459,000 | 13,075,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of period | 11,286,000 | 7,934,000 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 2,854,000 | 3,070,000 |
Cash paid for income taxes | 20,000 | 10,000 |
Supplemental schedule of non-cash investing and financing activities: | ||
Property and equipment acquired under finance leases | 776,000 | 124,000 |
Property and equipment acquired under operating leases | 0 | 676,000 |
Note payable end of term payment accrued but unpaid | $ 2,125,000 | $ 1,800,000 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements Of Changes in Shareholders' (Deficit) Equity - 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, 2018 | 4,671,921 | 600,000 | 10,150 | |||||
Beginning balance at Dec. 31, 2018 | $ 47 | $ 19,227 | $ 11,117 | $ 346,762 | $ 3,707 | $ (377,127) | $ (1,011) | $ 2,722 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 59,319 | |||||||
Issuance of common stock, net of issuance costs | ||||||||
Stock-based compensation expense | 770 | 770 | ||||||
Net loss | (2,763) | (2,763) | ||||||
Foreign currency translation adjustments | (83) | (83) | ||||||
Ending balance (in shares) at Mar. 31, 2019 | 4,731,240 | 600,000 | 10,150 | |||||
Ending balance at Mar. 31, 2019 | $ 47 | $ 19,227 | $ 11,117 | 347,532 | 3,707 | (379,890) | (1,094) | 646 |
Beginning balance (in shares) at Dec. 31, 2018 | 4,671,921 | 600,000 | 10,150 | |||||
Beginning balance at Dec. 31, 2018 | $ 47 | $ 19,227 | $ 11,117 | 346,762 | 3,707 | (377,127) | (1,011) | $ 2,722 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | ||||||||
Net loss | $ (10,941) | |||||||
Foreign currency translation adjustments | (193) | |||||||
Ending balance (in shares) at Sep. 30, 2019 | 4,734,382 | 600,000 | 10,150 | |||||
Ending balance at Sep. 30, 2019 | $ 47 | $ 19,227 | $ 11,117 | 348,698 | 3,707 | (388,068) | (1,204) | (6,476) |
Beginning balance (in shares) at Mar. 31, 2019 | 4,731,240 | 600,000 | 10,150 | |||||
Beginning balance at Mar. 31, 2019 | $ 47 | $ 19,227 | $ 11,117 | 347,532 | 3,707 | (379,890) | (1,094) | 646 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 2,124 | |||||||
Issuance of common stock, net of issuance costs | ||||||||
Stock-based compensation expense | 655 | 655 | ||||||
Net loss | (5,038) | (5,038) | ||||||
Foreign currency translation adjustments | 55 | 55 | ||||||
Ending balance (in shares) at Jun. 30, 2019 | 4,733,364 | 600,000 | 10,150 | |||||
Ending balance at Jun. 30, 2019 | $ 47 | $ 19,227 | $ 11,117 | 348,187 | 3,707 | (384,928) | (1,039) | (3,682) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Issuance of common stock, net of issuance costs (in shares) | 1,018 | |||||||
Issuance of common stock, net of issuance costs | 7 | $ 7 | ||||||
Exercise of stock options (in shares) | ||||||||
Stock-based compensation expense | 504 | $ 504 | ||||||
Net loss | (3,140) | (3,140) | ||||||
Foreign currency translation adjustments | (165) | (165) | ||||||
Ending balance (in shares) at Sep. 30, 2019 | 4,734,382 | 600,000 | 10,150 | |||||
Ending balance at Sep. 30, 2019 | $ 47 | $ 19,227 | $ 11,117 | 348,698 | 3,707 | (388,068) | (1,204) | (6,476) |
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 | |||||||
Issuance of common stock, net of issuance costs | ||||||||
Stock-based compensation expense | 440 | 440 | ||||||
Other | (115) | (115) | ||||||
Net 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] | ||||||||
Exercise of stock options (in shares) | ||||||||
Net loss | $ (4,362) | |||||||
Foreign currency translation adjustments | 205 | |||||||
Ending balance (in shares) at Sep. 30, 2020 | 5,131,744 | 600,000 | 8,650 | |||||
Ending balance at Sep. 30, 2020 | $ 51 | $ 19,227 | $ 9,474 | 352,728 | 3,707 | (391,932) | (888) | (7,633) |
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-based compensation expense | 317 | 317 | ||||||
Net 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) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Exercise of stock options (in shares) | ||||||||
Preferred stock conversion (in shares) | 99,999 | (1,500) | ||||||
Preferred stock conversion | $ 1 | $ (1,643) | 1,642 | |||||
Stock-based compensation expense | 317 | 317 | ||||||
Net loss | (618) | (618) | ||||||
Foreign currency translation adjustments | 198 | 198 | ||||||
Ending balance (in shares) at Sep. 30, 2020 | 5,131,744 | 600,000 | 8,650 | |||||
Ending balance at Sep. 30, 2020 | $ 51 | $ 19,227 | $ 9,474 | $ 352,728 | $ 3,707 | $ (391,932) | $ (888) | $ (7,633) |
Nature Of Operations
Nature Of Operations | 9 Months Ended |
Sep. 30, 2020 | |
Nature Of Operations [Abstract] | |
Nature Of Operations | 1. NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ophthalmic pharmaceuticals. The Company presently focuses on diseases affecting the back of the eye, or retina, because the Company believes these diseases are not well treated with current therapies and affect millions of people globally. The Company’s only product is ILUVIEN ® , which has received marketing authorization and reimbursement approval in 24 countries for the treatment of diabetic macular edema (DME). In addition, ILUVIEN has received marketing authorization in 1 6 European countries, and reimbursement approval in two countries, Germany and the U.K., 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. The Company has entered into various agreements under which distributors are providing or will provide to varying degrees regulatory, reimbursement and sales and marketing support for ILUVIEN in Austria, Belgium, the Czech Republic, Denmark, Finland, France, Italy, Luxembourg, the Netherlands, Norway, Spain, Sweden, Australia, New Zealand, Canada and several countries in the Middle East. As of September 30, 2020, the Company has recognized sales of ILUVIEN to the Company’s international distributors in the Middle East, France, Italy and Spain. |
Basis Of Presentation
Basis Of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
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, 2019 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on March 2, 2020. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. 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. The Company is currently unable to fully determine the COVID-19 pandemic’s future impact on the Company’s business. These limitations and other effects of the COVID-19 pandemic had an adverse impact on the Company’s revenues late in the first quarter and continuing through the third quarter of 2020. The Company expects these factors to continue to adversely impact the Company’s revenue, and the extent and duration of that impact is uncertain at this time. The Company is monitoring the pandemic and its potential effect on the Company’s financial position, results of operations and cash flows. 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 impact on the Company’s operations could have an adverse effect on the Company’s revenue, financial condition and cash flows. |
Summary Of Significant Accounti
Summary Of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
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, 2019. Reverse Stock Split On November 14, 2019, the Company filed a certificate of amendment to its restated certificate of incorporation with the Secretary of State of the State of Delaware, which effected a one-for-15 reverse stock split (the reverse split) of its issued and outstanding shares of common stock at 5:01 PM Eastern Time on that date. As a result of the reverse split, every 15 shares of common stock then issued and outstanding were converted into one share of common stock. The Company paid cash in lieu of fractional shares, and accordingly, no fractional shares were issued in connection with the reverse split. The reverse split did not change the par value of the common stock or the authorized number of shares of common stock. All outstanding options, preferred stock, restricted stock units, warrants and other securities entitling their holders to purchase or otherwise receive shares of Alimera’s common stock have been adjusted as a result of the reverse split, as required by the terms of each security. The number of shares available to be awarded under the 2019 Omnibus Incentive Plan and the number of shares that are purchasable under the 2010 Employee Stock Purchase Plan have also been appropriately adjusted. 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 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 becomes effective for the Company on January 1, 2021. The Company is in the process of determining the effect that the adoption will have on its financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The standard requires entities to provide expanded disclosures about the terms and features of convertible instruments and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and contracts on an entity’s own equity. The standard 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 | 9 Months Ended |
Sep. 30, 2020 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | 4. REVENUE RECOGNITION Net Revenue 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. All of the Company’s current contracts have a single performance obligation, as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and is, therefore, not distinct. All of the Company’s revenue is derived from product sales. 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. As of September 30, 2020, the Company had received a total of $ 1,000,000 of milestone payments in connection with the Company’s Canadian distributor that it has not recognized as revenue based on the Company’s analysis in connection with ASU 2014-09, Revenue from Contracts with Customers (ASC 606) . These deferred revenues are included as a component of other non-current liabilities on the Company’s balance sheets. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. With respect to the Company’s international contracts with third party distributors, certain contracts have elements of variable consideration, and management reviews those contracts on a regular basis and makes estimates of revenue based on historical ordering patterns and known market events and data. The amount of variable consideration included in net sales in each period could vary depending on the terms of these contracts and the probability of reversal in future periods. Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may either refund the sales price paid by the Customer by issuing a credit or exchanging the returned product for replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. The estimation process for product returns involves, in each case, several interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal. Other Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides; and a revenue share on net sales of licensed products. Each of these payments is recognized as other revenues. As part of the accounting for these arrangements, the Company must develop estimates that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Performance obligations are promises in a contract to transfer a distinct good or service to the Customer, and the Company recognizes revenue when, or as, performance obligations are satisfied. The Company uses key assumptions to determine the stand-alone selling price; these assumptions may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Certain of these agreements include consideration in the form of milestone payments. At the inception of each arrangement that includes milestone payments, the Company evaluates the recognition of milestone payments. Typically, milestone payments are associated with events that are not entirely within the control of the Company or the licensee, such as regulatory approvals, are included in the transaction price, and are subject to a constraint until it is probable that there will not be a significant revenue reversal, typically upon achievement of the milestone. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the timing of receipt of payment for the Company’s international Customers can be extended. 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 | 9 Months Ended |
Sep. 30, 2020 | |
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 United Kingdom 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 September 30, 2020 for the Company’s operating leases is as follows: (In thousands) NON-CURRENT ASSETS: Right of use assets, net $ 791 Total lease assets $ 791 CURRENT LIABILITIES: Accrued expenses $ 489 NON-CURRENT LIABILITIES: Other non-current liabilities 442 Total lease liabilities $ 931 The Company’s operating lease cost for the three and nine months ended September 30, 2020 was $ 113,000 and $ 338,000 , 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 nine months ended September 30, 2019 was $ 117,000 and $ 359,000 , respectively, and is included in general and administrative expenses in its condensed consolidated statement of operations. As of September 30, 2020, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2020 (remaining) $ 145 2021 459 2022 159 2023 159 2024 159 Thereafter — Total 1,081 Less amount representing interest ( 150 ) Present value of minimum lease payments 931 Less current portion ( 489 ) Non-current portion $ 442 Cash paid for operating leases was $ 464,000 during the nine months ended September 30, 2020. No right of use assets were obtained in exchange for operating leases for the nine months ended September 30, 2020. As of September 30, 2020, the weighted average remaining lease terms of the Company’s operating leases was 3.0 years. The weighted average discount rate used to determine the lease liabilities was 10.1 %. 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 September 30, 2020 and December 31, 2019 for the Company’s finance leases is as follows: September 30, December 31, 2020 2019 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 783 $ 414 Total lease assets $ 783 $ 414 CURRENT LIABILITIES: Finance lease obligations $ 219 $ 255 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 452 94 Total lease liabilities $ 671 $ 349 Depreciation expense associated with property and equipment under finance leases was approximately $ 101,000 and $ 83,000 for the three months ended September 30, 2020 and 2019, respectively. Depreciation expense associated with property and equipment under finance leases was approximately $ 294,000 and $ 236,000 for the nine months ended September 30, 2020 and 2019, respectively. Interest expense associated with finance leases was $ 14,000 and $ 9,000 for the three months ended September 30, 2020 and 2019, respectively. Interest expense associated with finance leases was $ 33,000 and $ 26,000 for the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, 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) 2020 (remaining) $ 103 2021 335 2022 208 2023 80 Total 726 Less amount representing interest ( 55 ) Present value of minimum lease payments 671 Less current portion ( 219 ) Non-current portion $ 452 Cash paid for finance leases was $ 486,000 during the nine months ended September 30, 2020. The Company acquired $ 776,000 of property and equipment in exchange for finance leases during the nine months ended September 30, 2020. As of September 30, 2020, the weighted average remaining lease terms of the Company’s financing leases was 1.6 years. The weighted average discount rate used to determine the financing lease liabilities was 8.7 %. |
Going Concern
Going Concern | 9 Months Ended |
Sep. 30, 2020 | |
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 $ 391,932,000 from inception through September 30, 2020. As of September 30, 2020, the Company had approximately $ 11,254,000 in cash and cash equivalents. The Company’s ability to avoid depleting its cash depends upon its ability to maintain revenue and contain its expenses. Should the impact of the COVID-19 pandemic be extended, the Company has plans in place to reduce its expenses further in the future. Further, the Company must maintain compliance with the debt covenants of its $ 45,000,000 Loan and Security Agreement with Solar Capital Ltd., 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 has from time to time been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses to satisfy its obligations due within one year from the date of issuance of these Interim Financial Statements, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity, contain expenses, or increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these Interim Financial Statements are issued. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2020 | |
Inventory [Abstract] | |
Inventory | 7. INVENTORY Inventory consisted of the following: September 30, December 31, 2020 2019 (In thousands) Component parts (1) $ 1,051 $ 389 Work-in-process (2) 416 399 Finished goods 1,055 602 Total Inventory $ 2,522 $ 1,390 (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 | 9 Months Ended |
Sep. 30, 2020 | |
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 acquisition date. The amortization expense related to the intangible asset was approximately $ 489,000 for both the three months ended September 30, 2020 and 2019, respectively. The amortization expense related to the intangible asset was approximately $ 1,457,000 for the nine months ended September 30, 2020 and $ 1,451,000 for the nine months ended September 30, 2019. The net book value of the intangible asset was $ 13,327,000 and $ 14,783,000 as of September 30, 2020 and December 31, 2019, respectively. The estimated future amortization expense as of September 30, 2020 for the remaining periods in the next five years and thereafter is as follows: Years Ending December 31 (In thousands) 2020 (remaining) $ 489 2021 1,940 2022 1,940 2023 1,940 2024 1,946 Thereafter 5,072 Total $ 13,327 Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. In April of 2020, as a result of the potential impact of the COVID-19 pandemic on the Company’s statements of operations, the Company performed an asset impairment analysis by comparing future undiscounted cash flows of the identified asset group to the carrying value of that asset group. The Company concluded no impairment was necessary. |
License Agreements
License Agreements | 9 Months Ended |
Sep. 30, 2020 | |
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. The Company began paying a 2 % royalty on net revenues and other related consideration to EyePoint on July 1, 2017. The royalty amount increased to 6 % effective December 12, 2018. The Company is required to pay an additional 2 % royalty on global net revenues and other related consideration in excess of $ 75,000,000 in any year. During the three and nine months ended September 30, 2020, the Company recognized approximately $ 499,000 and $ 1,481,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. As of September 30, 2020, approximately $ 499,000 of this royalty expense was included in the Company’s accounts payable. During the three and nine months ended September 30, 2019, the Company recognized approximately $ 514,000 and $ 1,464,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. 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 September 30, 2020, the balance of the Future Offset was approximately $ 8,117,000 . |
Loan Agreements
Loan Agreements | 9 Months Ended |
Sep. 30, 2020 | |
Loan Agreements [Abstract] | |
Loan Agreements | 10. LOAN AGREEMENTS Hercules Loan Agreement and Related Warrants In April 2014, Alimera Sciences Limited (Alimera UK), a subsidiary of the Company, entered into a loan and security agreement (Hercules Loan Agreement) with Hercules Capital, Inc. (Hercules) providing for a term loan of up to $ 35,000,000 (Hercules Loan). The Company amended the Hercules Loan Agreement several times. On January 5, 2018, the Company paid off the Hercules Loan on behalf of Alimera UK, using the proceeds of the 2018 Solar Loan Agreement described below. In connection with Alimera UK entering into the Hercules Loan Agreement, the Company issued a warrant that granted Hercules the right to purchase up to 19,002 shares of the Company’s common stock at an exercise price of $ 92.10 per share (the 2014 Warrant). The Company amended the 2014 Warrant a number of times to increase the number of shares issuable upon exercise to 83,933 and decrease the exercise price to $ 20.85 per share. The right to exercise this warrant expired on November 2, 2020. In connection with Alimera UK entering into an amendment to the Hercules Loan Agreement on October 20, 2016, the Company agreed to issue a new warrant to Hercules (the 2016 Warrant) 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. 2019 Solar Capital Loan Agreement On December 31, 2019, we refinanced our $ 40.0 million Loan and Security Agreement (the 2018 Solar Loan Agreement) with Solar Capital Ltd. (Solar Capital) and other lenders by entering into a $ 45.0 million Loan and Security Agreement (the 2019 Solar Loan Agreement) with Solar Capital as Collateral Agent (Agent), and the parties signing the 2018 Solar Loan Agreement from time to time as Lenders, including Solar Capital in its capacity as a Lender. Under the 2019 Solar Loan Agreement, we borrowed $ 42.5 million on December 31, 2019 and $ 2.5 million on February 21, 2020 (the 2019 Solar Loan). The 2019 Solar Loan matures on July 1, 2024. We used the initial proceeds of the 2019 Solar Loan to pay off borrowings under the 2018 Solar Loan Agreement (the 2018 Solar Loan), along with related prepayment, legal and other fees and expenses totaling approximately $ 2.3 million, which included $ 2.2 million in fees to Solar Capital. In addition, the Company is obligated to pay a $ 2,250,000 fee upon repayment of the 2019 Solar Loan. 2018 Exit Fee Agreement Notwithstanding the repayment of the 2018 Solar 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, Solar Capital as Agent, and the Lenders. The 2018 Exit Fee Agreement survived the termination of the 2018 Solar Loan Agreement upon the repayment of the 2018 Solar Loan 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. First Amendment to 2019 Solar Capital Loan Agreement On May 1, 2020, the Company entered into a First Amendment (the Amendment) to its 2019 Solar Loan Agreement with Solar Capital. The Amendment, among other things: (a) eliminates the previous requirement that the following covenant (the Revenue Covenant) be measured at June 30, 2020 and September 30, 2020: the Company shall not permit revenues (under U.S. GAAP) from the sale of ILUVIEN in the ordinary course of business to third party customers, on a trailing six-month basis, to be less than a specified minimum revenue amount for each such date; (b) requires that the Revenue Covenant be measured at November 30, 2020 and specifies a new minimum revenue amount in that regard; (c) requires that the Revenue Covenant be measured at December 31, 2020 and specifies a new minimum revenue amount in that regard; and (d) requires that the 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 an annual plan submitted by the Company to Agent by January 15th of such year, such plan to be approved by the Company’s board of directors and Agent in its sole discretion. The Amendment also adds the following new minimum liquidity requirement that is in effect from May 1, 2020 until the Company notifies Agent that it has met the Revenue Covenant at November 30, 2020: the Company shall not permit the aggregate amount of unrestricted cash and cash equivalents to be less than the sum of (i) $ 8,500,000 plus (ii) the amount of the Company’s accounts payable that have not been paid within 90 days from the invoice date of the relevant account payable. The Company paid no fees to Solar Capital in connection with the Amendment; however, the Company agreed to reimburse Agent for its legal fees. As of September 30, 2020, the Company was in compliance with the covenants of the Amendment to its 2019 Solar Loan Agreement. Paycheck Protection Program On April 22, 2020, the Company received an approximately $1,778,000 loan (the PPP Loan) under the Paycheck Protection Program established by the U.S. Small Business Administration (the SBA) as part of the Coronavirus Aid, Relief and Economic Security Act, or the CARES Act. The PPP Loan is unsecured and is evidenced by a note (the Note) in favor of HSBC Bank USA, National Association (HSBC) as the lender. The interest rate on the Note is 1.0% per annum. The Note has a two-year term and is payable in 18 equal monthly payments of principal and interest beginning on the 180th day following the disbursement of the loan proceeds, subject to possible full forgiveness and a deferred commencement date for beginning payments as described below. The Paycheck Protection Program provides for forgiveness of up to the full amount borrowed as long as the Company uses the loan proceeds during the 24-week period following disbursement for eligible purposes as described in the CARES Act and related guidance. Under the CARES Act, loan forgiveness is generally available for the sum of documented payroll costs, covered rent payments, covered mortgage interest and covered utilities during the 24-week period. The Company used all of the proceeds from the PPP Loan to pay expenses during the applicable period that the Company believes were for eligible purposes. On July 21, 2020, the Company submitted an application to HSBC for forgiveness of the PPP Loan. As of the date of this filing, the application for forgiveness is still pending review. Under the revised rules for the PPP Loan program, the Company will not have to begin principal and interest payments before the date on which the SBA remits the loan forgiveness amount to HSBC (or notifies HSBC that no loan forgiveness is allowed). If no loan forgiveness is allowed, the Company will be required to pay HSBC equal monthly payments of principal and interest based on the principal amount outstanding on the PPP Loan, plus interest outstanding at the end of the deferment period, and taking into account any reductions in the principal amount due to forgiveness, if any. Interest accrued during the deferment period will be capitalized as principal. In connection with the PPP Loan, the Company entered into a Consent to Loan and Security Agreement (the Consent) under the 2019 Solar Loan Agreement. In the Consent, Solar Capital consented as Collateral Agent and a Lender, and the other Lenders consented as Lenders, to the indebtedness incurred under the PPP Loan, subject to certain conditions, including the Company’s covenant to comply with specified provisions of the CARES Act, the Company’s confirmation of the accuracy of its representations and warranties in the 2019 Solar Loan Agreement and related documents and a release in favor of the Collateral Agent and the Lenders. The Company has accounted for the PPP Loan in the same manner as it has for its other loan agreements. Payments that are due within 12 months of balance sheet dates are shown as current liabilities and payments due thereafter are shown as non-current liabilities. The Company incurred and capitalized insignificant costs with third parties as deferred financing costs associated with the PPP Loan and is expensing these costs to interest expense over the life of the loan using the effective interest method. If the Company’s application for forgiveness is approved, the Company will recognize a gain on extinguishment of debt at the time of forgiveness. Modification of Debt In accordance with the guidance in ASC 470-50, Debt , the Company entered into and accounted for the 2019 Solar 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 accordance with the guidance in ASC 470-50, Debt , the Company entered into and accounted for the May 1, 2020 Amendment to its 2019 Solar Loan Agreement as a modification, capitalized no additional costs and expensed approximately $ 76,000 of costs incurred with third parties within the consolidated statements of operations for the nine months ended September 30, 2020. 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 September 30, 2020 and December 31, 2019. |
Earnings (Loss) Per Sare (EPS)
Earnings (Loss) Per Sare (EPS) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings (Loss) Per Sare (EPS) [Abstract] | |
Earnings (Loss) Per Sare (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 (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. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: September 30, 2020 2019 Series A convertible preferred stock 601,504 601,504 Series C convertible preferred stock 576,669 676,667 Common stock warrants 119,712 119,712 Stock options 1,040,987 880,096 Restricted stock & RSUs outstanding at period end 30,086 36,763 Total 2,368,958 2,314,742 |
Preferred Stock
Preferred Stock | 9 Months Ended |
Sep. 30, 2020 | |
Preferred Stock [Abstract] | |
Preferred Stock | 12. PREFERRED STOCK On August 28, 2020, the Company issued 99,999 shares of common stock pursuant to the conversion of 1,499.967 shares of Series C Preferred Stock. As of September 30, 2020, there were 8,650.033 shares of Series C Preferred Stock issued and outstanding. |
Stock Incentive Plans
Stock Incentive Plans | 9 Months Ended |
Sep. 30, 2020 | |
Stock Incentive Plans [Abstract] | |
Stock Incentive Plans | 13. STOCK INCENTIVE PLANS Stock Option Plans During the three months ended September 30, 2020 and 2019, the Company recorded compensation expense related to stock options of approximately $ 282,000 and $ 408,000 , respectively. During the nine months ended September 30, 2020 and 2019, the Company recorded compensation expense related to stock options of approximately $ 853,000 and $ 1,470,000 , respectively. As of September 30, 2020, the total unrecognized compensation cost related to non-vested stock options granted was $ 1,716,000 and is expected to be recognized over a weighted average period of 2.27 years. The following table presents a summary of stock option activity for the three months ended September 30, 2020 and 2019: Three Months Ended September 30, 2020 2019 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,043,297 29.84 912,430 36.04 Grants 2,450 5.46 5,412 12.65 Forfeitures ( 4,760 ) 28.29 ( 37,748 ) 47.34 Exercises — — — — Options outstanding at period end 1,040,987 29.79 880,094 35.41 Options exercisable at period end 764,151 36.91 648,880 42.25 Weighted average per share fair value of options granted during the period $ 3.48 $ 7.65 The following table presents a summary of stock option activity for the nine months ended September 30, 2020 and 2019: Nine Months Ended September 30, 2020 2019 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 871,472 35.46 830,100 39.41 Grants 198,731 6.70 126,948 13.45 Forfeitures ( 29,216 ) 42.00 ( 76,954 ) 42.31 Exercises — — — — Options outstanding at period end 1,040,987 29.79 880,094 35.41 Options exercisable at period end 764,151 36.91 648,880 42.25 Weighted average per share fair value of options granted during the period $ 4.17 $ 8.34 The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of September 30, 2020: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,040,987 29.79 5.94 years 1 Exercisable 764,151 36.91 4.92 years — Outstanding, vested and expected to vest 1,007,268 30.48 5.84 years 1 The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of December 31, 2019: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 871,472 35.46 5.83 years 4 Exercisable 674,952 41.25 5.04 years — Outstanding, vested and expected to vest 849,285 36.00 5.75 years 3 As of September 30, 2020, 239,565 shares remain available for grant under the 2019 Omnibus Incentive Plan. Employee Stock Purchase Plan During the three months ended September 30, 2020 and 2019, the Company recorded compensation expense related to its employee stock purchase plan of approximately $ 13,000 and $ 6,000 , respectively. During the nine months ended September 30, 2020 and 2019, the Company recorded compensation expense related to its employee stock purchase plan of approximately $ 51,000 and $ 17,000 , respectively. 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 September 30, 2020 2019 Weighted Weighted Restricted Average Restricted Average Stock & RSUs Grant Date Stock & RSUs Grant Date RSUs Fair Value ($) RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 30,086 3.12 36,763 13.15 Grants — — — — Vested units — — — — Forfeitures — — — — Restricted stock & RSUs outstanding at period end 30,086 3.12 36,763 13.15 Nine Months Ended September 30, 2020 2019 Weighted Weighted Restricted Average Restricted Average Stock & RSUs Grant Date Stock & RSUs Grant Date RSUs Fair Value ($) RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 36,763 13.15 60,041 17.30 Grants 30,086 3.12 36,763 13.15 Vested units ( 36,763 ) 13.15 ( 60,041 ) 17.29 Forfeitures — — — — Restricted stock & RSUs outstanding at period end 30,086 3.12 36,763 13.15 Employee stock-based compensation expense related to restricted stock and RSUs recognized in accordance with ASC 718, Compensation - Stock Compensation (ASC 718) was $ 22,000 and $ 90,000 for the three months ended September 30, 2020 and 2019, respectively. Employee stock-based compensation expense related to RSUs recognized in accordance with ASC 718 was $ 170,000 and $ 416,000 for the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, the total unrecognized compensation cost related to restricted stock was $ 47,000 and is expected to be recognized over a weighted average period of 0.44 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2020 | |
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. The Company’s recorded liability for uncertain tax positions as of September 30, 2020 has increased by approximately $ 4,500 as compared to December 31, 2019. 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. On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (CARES) Act was enacted and signed into law. In addition to other provisions, the CARES Act contains modifications to Net Operating Loss (NOL) carryback rules. For the nine months ended September 30, 2020, there was no impact to the tax provision related to the CARES Act. We are currently evaluating the provisions of the CARES Act and how other elections may impact our financial position, results of operations, and disclosures, if needed. At December 31, 2019, the Company had U.S. federal NOL carry-forwards of approximately $ 125,756,000 and state NOL carry-forwards of approximately $ 172,993,000 available to reduce future taxable income. The Company’s U.S. federal NOL carry-forwards remain fully reserved as of September 30, 2020. Except for the NOLs generated after 2017, the U.S. federal NOLs not fully utilized will expire at various dates between 2029 and 2037; most state NOL carry-forwards will expire at various dates between 2020 and 2039. 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, 2019, the Company had cumulative book losses in foreign subsidiaries of $ 134,379,000 . The Company has not recorded a deferred tax asset for the excess of tax over book basis in the stock of its foreign subsidiaries. The Company anticipates that its foreign subsidiaries will be profitable and have earnings in the future. Once the foreign subsidiaries do have earnings, 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 has not recorded a deferred tax liability related to excess of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2020 | |
Segment Information [Abstract] | |
Segment Information | 15. SEGMENT INFORMATION The Company’s chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic environment. Each segment is separately managed and is evaluated primarily upon segment gain or loss from operations. Non-cash items including stock-based compensation expense and depreciation and amortization are categorized as Other within the table below. The Company does not report balance sheet information by segment because the Company’s chief operating decision maker does not review that information. The following table presents a summary of the Company’s reporting segments for the three months ended September 30, 2020 and 2019: Three Months Ended Three Months Ended September 30, 2020 September 30, 2019 U.S. International Other Consolidated U.S. International Other Consolidated (In thousands) NET REVENUE $ 6,962 $ 5,511 $ — $ 12,473 $ 8,692 $ 4,158 $ — $ 12,850 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 746 ) ( 791 ) — ( 1,537 ) ( 1,001 ) ( 578 ) — ( 1,579 ) GROSS PROFIT 6,216 4,720 — 10,936 7,691 3,580 — 11,271 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,560 861 48 2,469 1,573 1,100 88 2,761 GENERAL AND ADMINISTRATIVE EXPENSES 1,952 475 192 2,619 2,032 768 321 3,121 SALES AND MARKETING EXPENSES 3,461 1,226 77 4,764 4,502 1,840 95 6,437 DEPRECIATION AND AMORTIZATION — — 677 677 — — 668 668 OPERATING EXPENSES 6,973 2,562 994 10,529 8,107 3,708 1,172 12,987 SEGMENT (LOSS) INCOME FROM OPERATIONS ( 757 ) 2,158 ( 994 ) 407 ( 416 ) ( 128 ) ( 1,172 ) ( 1,716 ) OTHER INCOME AND EXPENSES, NET — — ( 1,018 ) ( 1,018 ) — — ( 1,347 ) ( 1,347 ) NET LOSS BEFORE TAXES $ ( 611 ) $ ( 3,063 ) The following table presents a summary of the Company’s reporting segments for the nine months ended September 30, 2020 and 2019: Nine Months Ended Nine Months Ended September 30, 2020 September 30, 2019 U.S. International Other Consolidated U.S. International Other Consolidated (In thousands) NET REVENUE $ 17,449 $ 19,597 $ — $ 37,046 $ 22,778 $ 13,817 $ — $ 36,595 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,928 ) ( 3,021 ) — ( 4,949 ) ( 2,494 ) ( 1,859 ) — ( 4,353 ) GROSS PROFIT 15,521 16,576 — 32,097 20,284 11,958 — 32,242 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 4,580 2,418 164 7,162 4,629 3,361 332 8,322 GENERAL AND ADMINISTRATIVE EXPENSES 5,867 2,250 658 8,775 6,116 2,876 1,197 10,189 SALES AND MARKETING EXPENSES 10,948 3,618 252 14,818 12,760 5,324 374 18,458 DEPRECIATION AND AMORTIZATION — — 2,016 2,016 — — 1,974 1,974 OPERATING EXPENSES 21,395 8,286 3,090 32,771 23,505 11,561 3,877 38,943 SEGMENT (LOSS) INCOME FROM OPERATIONS ( 5,874 ) 8,290 ( 3,090 ) ( 674 ) ( 3,221 ) 397 ( 3,877 ) ( 6,701 ) OTHER INCOME AND EXPENSES, NET — — ( 3,633 ) ( 3,633 ) — — ( 3,831 ) ( 3,831 ) NET LOSS BEFORE TAXES $ ( 4,307 ) $ ( 10,532 ) During the three months ended September 30, 2020 and 2019, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 56 % and 68 %, respectively, of the Company’s consolidated revenues. During the nine months ended September 30, 2020 and 2019, these two customers within the U.S. segment accounted for 47 % and 62 %, respectively, of the Company’s consolidated revenues. These same two customers within the U.S. segment accounted for approximately 65 % and 68 % of the Company’s consolidated accounts receivable at September 30, 2020 and at December 31, 2019, respectively. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 16. SUBSEQUENT EVENTS On October 30, 2020, the Company entered into a Manufacturing Services Agreement (the Cadence Agreement) with Cadence, Inc., under which Cadence will manufacture certain component parts of the ILUVIEN applicator (the components) at its facility near Pittsburgh, Pennsylvania. Under the Cadence Agreement, the Company will pay certain per-unit prices based on regularly scheduled shipments of a minimum number of components. The initial term of the Cadence Agreement expires on October 30, 2025. After the expiration of the initial term, the Cadence Agreement will automatically renew for separate but successive one-year terms unless either party provides written notice to the other party that it does not intend to renew the Cadence Agreement at least 24 months before the end of the term. The Cadence Agreement may be terminated by either party under certain circumstances. The foregoing description of the Cadence Agreement does not purport to be complete and is qualified in its entirety by the full text of the Cadence Agreement, a copy of which is filed as Exhibit 10.16 to this report. |
Summary Of Significant Accoun_2
Summary Of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Summary Of Significant Accounting Policies [Abstract] | |
Reverse Stock Split | Reverse Stock Split On November 14, 2019, the Company filed a certificate of amendment to its restated certificate of incorporation with the Secretary of State of the State of Delaware, which effected a one-for-15 reverse stock split (the reverse split) of its issued and outstanding shares of common stock at 5:01 PM Eastern Time on that date. As a result of the reverse split, every 15 shares of common stock then issued and outstanding were converted into one share of common stock. The Company paid cash in lieu of fractional shares, and accordingly, no fractional shares were issued in connection with the reverse split. The reverse split did not change the par value of the common stock or the authorized number of shares of common stock. All outstanding options, preferred stock, restricted stock units, warrants and other securities entitling their holders to purchase or otherwise receive shares of Alimera’s common stock have been adjusted as a result of the reverse split, as required by the terms of each security. The number of shares available to be awarded under the 2019 Omnibus Incentive Plan and the number of shares that are purchasable under the 2010 Employee Stock Purchase Plan have also been appropriately adjusted. |
Accounting Standards Issued but Not Yet Effective | 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 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 becomes effective for the Company on January 1, 2021. The Company is in the process of determining the effect that the adoption will have on its financial statements. In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The standard requires entities to provide expanded disclosures about the terms and features of convertible instruments and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and contracts on an entity’s own equity. The standard 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) | 9 Months Ended |
Sep. 30, 2020 | |
Leases [Abstract] | |
Summary of Operating Leases Supplemental Balance Sheet Information | (In thousands) NON-CURRENT ASSETS: Right of use assets, net $ 791 Total lease assets $ 791 CURRENT LIABILITIES: Accrued expenses $ 489 NON-CURRENT LIABILITIES: Other non-current liabilities 442 Total lease liabilities $ 931 |
Schedule of Future Minimum Operating Lease Payments | Years Ending December 31 (In thousands) 2020 (remaining) $ 145 2021 459 2022 159 2023 159 2024 159 Thereafter — Total 1,081 Less amount representing interest ( 150 ) Present value of minimum lease payments 931 Less current portion ( 489 ) Non-current portion $ 442 |
Summary of Finance Leases Supplemental Balance Sheet Information | September 30, December 31, 2020 2019 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 783 $ 414 Total lease assets $ 783 $ 414 CURRENT LIABILITIES: Finance lease obligations $ 219 $ 255 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 452 94 Total lease liabilities $ 671 $ 349 |
Schedule of Future Minimun Finance Lease Payments | Years Ending December 31 (In thousands) 2020 (remaining) $ 103 2021 335 2022 208 2023 80 Total 726 Less amount representing interest ( 55 ) Present value of minimum lease payments 671 Less current portion ( 219 ) Non-current portion $ 452 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory [Abstract] | |
Schedule of Inventory | September 30, December 31, 2020 2019 (In thousands) Component parts (1) $ 1,051 $ 389 Work-in-process (2) 416 399 Finished goods 1,055 602 Total Inventory $ 2,522 $ 1,390 (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) | 9 Months Ended |
Sep. 30, 2020 | |
Intangible Asset [Abstract] | |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | Years Ending December 31 (In thousands) 2020 (remaining) $ 489 2021 1,940 2022 1,940 2023 1,940 2024 1,946 Thereafter 5,072 Total $ 13,327 |
Earnings (Loss) Per Share (EPS)
Earnings (Loss) Per Share (EPS) (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Earnings (Loss) Per Sare (EPS) [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | September 30, 2020 2019 Series A convertible preferred stock 601,504 601,504 Series C convertible preferred stock 576,669 676,667 Common stock warrants 119,712 119,712 Stock options 1,040,987 880,096 Restricted stock & RSUs outstanding at period end 30,086 36,763 Total 2,368,958 2,314,742 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stock Incentive Plans [Abstract] | |
Summary of Stock Option Transactions | The following table presents a summary of stock option activity for the three months ended September 30, 2020 and 2019: Three Months Ended September 30, 2020 2019 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 1,043,297 29.84 912,430 36.04 Grants 2,450 5.46 5,412 12.65 Forfeitures ( 4,760 ) 28.29 ( 37,748 ) 47.34 Exercises — — — — Options outstanding at period end 1,040,987 29.79 880,094 35.41 Options exercisable at period end 764,151 36.91 648,880 42.25 Weighted average per share fair value of options granted during the period $ 3.48 $ 7.65 The following table presents a summary of stock option activity for the nine months ended September 30, 2020 and 2019: Nine Months Ended September 30, 2020 2019 Weighted Weighted Average Average Exercise Exercise Options Price ($) Options Price ($) Options outstanding at beginning of period 871,472 35.46 830,100 39.41 Grants 198,731 6.70 126,948 13.45 Forfeitures ( 29,216 ) 42.00 ( 76,954 ) 42.31 Exercises — — — — Options outstanding at period end 1,040,987 29.79 880,094 35.41 Options exercisable at period end 764,151 36.91 648,880 42.25 Weighted average per share fair value of options granted during the period $ 4.17 $ 8.34 |
Summary of Additional Stock Option Transactions | The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of September 30, 2020: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 1,040,987 29.79 5.94 years 1 Exercisable 764,151 36.91 4.92 years — Outstanding, vested and expected to vest 1,007,268 30.48 5.84 years 1 The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of December 31, 2019: Weighted Weighted Average Average Remaining Aggregate Exercise Contractual Intrinsic Shares Price ($) Term Value ($) (In thousands) Outstanding 871,472 35.46 5.83 years 4 Exercisable 674,952 41.25 5.04 years — Outstanding, vested and expected to vest 849,285 36.00 5.75 years 3 |
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 September 30, 2020 2019 Weighted Weighted Restricted Average Restricted Average Stock & RSUs Grant Date Stock & RSUs Grant Date RSUs Fair Value ($) RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 30,086 3.12 36,763 13.15 Grants — — — — Vested units — — — — Forfeitures — — — — Restricted stock & RSUs outstanding at period end 30,086 3.12 36,763 13.15 Nine Months Ended September 30, 2020 2019 Weighted Weighted Restricted Average Restricted Average Stock & RSUs Grant Date Stock & RSUs Grant Date RSUs Fair Value ($) RSUs Fair Value ($) Restricted stock & RSUs outstanding at beginning of period 36,763 13.15 60,041 17.30 Grants 30,086 3.12 36,763 13.15 Vested units ( 36,763 ) 13.15 ( 60,041 ) 17.29 Forfeitures — — — — Restricted stock & RSUs outstanding at period end 30,086 3.12 36,763 13.15 |
Segment Information (Tables)
Segment Information (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Segment Information [Abstract] | |
Schedule of Reporting Segments | The following table presents a summary of the Company’s reporting segments for the three months ended September 30, 2020 and 2019: Three Months Ended Three Months Ended September 30, 2020 September 30, 2019 U.S. International Other Consolidated U.S. International Other Consolidated (In thousands) NET REVENUE $ 6,962 $ 5,511 $ — $ 12,473 $ 8,692 $ 4,158 $ — $ 12,850 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 746 ) ( 791 ) — ( 1,537 ) ( 1,001 ) ( 578 ) — ( 1,579 ) GROSS PROFIT 6,216 4,720 — 10,936 7,691 3,580 — 11,271 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,560 861 48 2,469 1,573 1,100 88 2,761 GENERAL AND ADMINISTRATIVE EXPENSES 1,952 475 192 2,619 2,032 768 321 3,121 SALES AND MARKETING EXPENSES 3,461 1,226 77 4,764 4,502 1,840 95 6,437 DEPRECIATION AND AMORTIZATION — — 677 677 — — 668 668 OPERATING EXPENSES 6,973 2,562 994 10,529 8,107 3,708 1,172 12,987 SEGMENT (LOSS) INCOME FROM OPERATIONS ( 757 ) 2,158 ( 994 ) 407 ( 416 ) ( 128 ) ( 1,172 ) ( 1,716 ) OTHER INCOME AND EXPENSES, NET — — ( 1,018 ) ( 1,018 ) — — ( 1,347 ) ( 1,347 ) NET LOSS BEFORE TAXES $ ( 611 ) $ ( 3,063 ) The following table presents a summary of the Company’s reporting segments for the nine months ended September 30, 2020 and 2019: Nine Months Ended Nine Months Ended September 30, 2020 September 30, 2019 U.S. International Other Consolidated U.S. International Other Consolidated (In thousands) NET REVENUE $ 17,449 $ 19,597 $ — $ 37,046 $ 22,778 $ 13,817 $ — $ 36,595 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION ( 1,928 ) ( 3,021 ) — ( 4,949 ) ( 2,494 ) ( 1,859 ) — ( 4,353 ) GROSS PROFIT 15,521 16,576 — 32,097 20,284 11,958 — 32,242 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 4,580 2,418 164 7,162 4,629 3,361 332 8,322 GENERAL AND ADMINISTRATIVE EXPENSES 5,867 2,250 658 8,775 6,116 2,876 1,197 10,189 SALES AND MARKETING EXPENSES 10,948 3,618 252 14,818 12,760 5,324 374 18,458 DEPRECIATION AND AMORTIZATION — — 2,016 2,016 — — 1,974 1,974 OPERATING EXPENSES 21,395 8,286 3,090 32,771 23,505 11,561 3,877 38,943 SEGMENT (LOSS) INCOME FROM OPERATIONS ( 5,874 ) 8,290 ( 3,090 ) ( 674 ) ( 3,221 ) 397 ( 3,877 ) ( 6,701 ) OTHER INCOME AND EXPENSES, NET — — ( 3,633 ) ( 3,633 ) — — ( 3,831 ) ( 3,831 ) NET LOSS BEFORE TAXES $ ( 4,307 ) $ ( 10,532 ) |
Nature Of Operations (Narrative
Nature Of Operations (Narrative) (Details) - ILUVIEN | Sep. 30, 2020country |
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 | 1 |
Number of countries in which product is indicated for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye | 2 |
Summary Of Significant Accoun_3
Summary Of Significant Accounting Policies (Narrative) (Details) $ in Thousands | Nov. 14, 2019shares | Sep. 30, 2020USD ($) | Dec. 31, 2019USD ($) |
Summary Of Significant Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ | $ 11,254 | $ 9,426 | |
Reverse stock split conversion ratio | 15 | ||
Fractional shares issued in connection with reverse split | shares | 0 |
Revenue Recognition (Narrative)
Revenue Recognition (Narrative) (Details) | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Revenue Recognition [Abstract] | |
Milestone payments not recognized as revenue, noncurrent | $ 1,000,000 |
Period before expiration date returns are accepted | 3 months |
Period after expiration date returns are accepted | 1 year |
Performance obligation, description of satisfaction timing | The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. |
Leases (Narrative) (Details)
Leases (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Lessee, Lease, Description [Line Items] | ||||
Operating lease cost | $ 113,000 | $ 117,000 | $ 338,000 | $ 359,000 |
Cash paid for leases | 464,000 | |||
Right-of-use asset obtained in exchange for operating lease liability | $ 0 | 676,000 | ||
Weighted average remaining lease term | 3 years | 3 years | ||
Weighted average discount rate, leases | 10.10% | 10.10% | ||
Depreciation expense property and equipment under finance leases | $ 101,000 | 83,000 | $ 294,000 | 236,000 |
Finance lease interest expense | $ 14,000 | $ 9,000 | 33,000 | 26,000 |
Cash paid for finance leases | 486,000 | |||
Property and equipment acquired under finance leases | $ 776,000 | $ 124,000 | ||
Finance lease, weighted average remaining term | 1 year 7 months 6 days | 1 year 7 months 6 days | ||
Finance lease, weighted average discount rate | 8.70% | 8.70% | ||
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 | Sep. 30, 2020 | Dec. 31, 2019 |
NON-CURRENT ASSETS: | ||
Operating lease, right-of-use asset | $ 791 | $ 1,107 |
CURRENT LIABILITIES: | ||
Accrued expenses | 489 | |
NON-CURRENT LIABILITIES: | ||
Other non-current liabilities | 442 | |
Total operating lease liabilities | $ 931 |
Leases (Schedule of Future Mini
Leases (Schedule of Future Minimum Operating Lease Payments) (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Leases [Abstract] | |
2020 (remaining) | $ 145 |
2021 | 459 |
2022 | 159 |
2023 | 159 |
2024 | 159 |
Thereafter | |
Total | 1,081 |
Less amount representing interest | (150) |
Total operating lease liabilities | 931 |
Less current portion | (489) |
Non-current portion | $ 442 |
Leases (Summary of Finance Leas
Leases (Summary of Finance Leases Supplemental Balance Sheet Information) (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | $ 783 | $ 414 |
Total lease assets | 783 | 414 |
CURRENT LIABILITIES: | ||
Finance lease obligations | 219 | 255 |
NON-CURRENT LIABILITIES: | ||
Finance lease obligations — less current portion | 452 | 94 |
Total finance lease liabilities | $ 671 | $ 349 |
Leases (Schedule of Future Mi_2
Leases (Schedule of Future Minimun Finance Lease Payments) (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Leases [Abstract] | ||
2020 (remaining) | $ 103 | |
2021 | 335 | |
2022 | 208 | |
2023 | 80 | |
Total | 726 | |
Less amount representing interest | (55) | |
Total finance lease liabilities | 671 | $ 349 |
Less current portion | (219) | (255) |
Non-current portion | $ 452 | $ 94 |
Going Concern (Narrative) (Deta
Going Concern (Narrative) (Details) - USD ($) | Sep. 30, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Accumulated deficit | $ 391,932,000 | $ 387,570,000 |
Cash and cash equivalents | 11,254,000 | $ 9,426,000 |
2019 Solar Loan Agreement | ||
Debt Instrument [Line Items] | ||
Debt instrument, face amount | $ 45,000,000 |
Inventory (Schedule of Inventor
Inventory (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Inventory | ||
Component parts | $ 1,051 | $ 389 |
Work-in-process | 416 | 399 |
Finished goods | 1,055 | 602 |
Total Inventory | $ 2,522 | $ 1,390 |
Intangible Asset (Narrative) (D
Intangible Asset (Narrative) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2014 | Dec. 31, 2019 | |
Finite-Lived Intangible Assets [Line Items] | ||||||
Amortization of intangible assets | $ 1,457,000 | $ 1,451,000 | ||||
Net intangible assets | $ 13,327,000 | 13,327,000 | $ 14,783,000 | |||
Impairment | 0 | |||||
License | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Gross intangible assets | 25,000,000 | $ 25,000,000 | ||||
Useful life (in years) | 13 years | |||||
Amortization of intangible assets | 489,000 | $ 489,000 | ||||
Net intangible assets | $ 13,327,000 | $ 14,783,000 | $ 13,327,000 | $ 14,783,000 | ||
pSivida | ||||||
Finite-Lived Intangible Assets [Line Items] | ||||||
Milestone payment after the first product approved by the FDA | $ 25,000,000 |
Intangible Asset (Future Amorti
Intangible Asset (Future Amortization) (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
Total | $ 13,327 | $ 14,783 | |
License | |||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
2020 (remaining) | 489 | ||
2021 | 1,940 | ||
2022 | 1,940 | ||
2023 | 1,940 | ||
2024 | 1,946 | ||
Thereafter | 5,072 | ||
Total | $ 13,327 | $ 14,783 |
License Agreements (Narrative)
License Agreements (Narrative) (Details) - USD ($) | Dec. 12, 2018 | Jul. 01, 2017 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Aug. 01, 2017 |
pSivida | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Collaborative arrangement, royalty payable on net revenue, percentage | 6.00% | 2.00% | ||||||
Collaborative arrangement, royalty payable on net revenue over threshold, percentage | 2.00% | |||||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000,000 | |||||||
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 | $ 8,117,000 | 8,117,000 | $ 15,000,000 | |||||
New Collaboration Agreement, 2017 Second Amended | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Royalty expense | 499,000 | $ 514,000 | 1,481,000 | $ 1,464,000 | ||||
Accrued royalty expense | $ 499,000 | $ 499,000 |
Loan Agreements (Hercules Loan
Loan Agreements (Hercules Loan Agreement) (Narrative) (Details) $ in Thousands | Apr. 30, 2014USD ($) |
Alimera Sciences Limited (Limited) | Hercules Technology Growth Capital, Inc. | 2014 Term Loan | |
Line of Credit Facility [Line Items] | |
Line of credit maximum borrowing capacity | $ 35,000 |
Loan Agreements (2014 Warrant)
Loan Agreements (2014 Warrant) (Narrative) (Details) - $ / shares | Sep. 30, 2020 | Apr. 30, 2014 |
2014 Term Loan | ||
Debt Instrument [Line Items] | ||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 19,002 | |
Class of warrant or right, exercise price of warrants or rights (usd per share) | $ 92.10 | |
July 2016 Waiver | ||
Debt Instrument [Line Items] | ||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 83,933 | |
Class of warrant or right, exercise price of warrants or rights (usd per share) | $ 20.85 |
Loan Agreements (2016 Warrant)
Loan Agreements (2016 Warrant) (Narrative) (Details) - Alimera Sciences Limited (Limited) - Hercules Technology Growth Capital, Inc. - Fourth Loan Amendment | Oct. 20, 2016$ / 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 |
Loan Agreements (Solar Capital
Loan Agreements (Solar Capital Loan Agreement) (Narrative) (Details) - USD ($) | Jan. 05, 2018 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | Nov. 30, 2020 | Feb. 21, 2020 |
Debt Instrument [Line Items] | ||||||||
Net revenue | $ 12,473,000 | $ 12,850,000 | $ 37,046,000 | $ 36,595,000 | ||||
2018 Term Loan | Solar Capital Ltd. | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 40,000,000 | |||||||
Debt instrument repayment fee amount, paid | 2,200,000 | |||||||
Debt instrument prepayment fee paid | 2,300,000 | |||||||
2019 Solar Loan Agreement | Solar Capital Ltd. | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | 45,000,000 | |||||||
Line of credit | 42,500,000 | $ 2,500,000 | ||||||
Debt instrument repayment fee amount, paid | $ 2,250,000 | |||||||
Debt instrument, period required from invoice date of relevant account payable | 90 days | |||||||
Agent fees | $ 0 | |||||||
Exit Fee Agreement | 2018 Term Loan | Solar Capital Ltd. | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, term | 10 years | |||||||
Debt instrument, exit fee | $ 2,000,000 | |||||||
Subsequent Event | 2019 Solar Loan Agreement | Solar Capital Ltd. | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt covenant, amount of unrestricted cash and cash equivalents | $ 8,500,000 |
Loan Agreements (Modification o
Loan Agreements (Modification of Debt) (Narrative) (Details) - Solar Capital Ltd. - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Sep. 30, 2020 | |
2019 Solar Loan Agreement | ||
Debt Instrument [Line Items] | ||
Deferred financing costs | $ 427,000 | |
Debt instrument, fee amount | 76,000 | |
Debt instrument repayment fee amount, paid | 2,250,000 | |
2019 Solar Loan Agreement | Amendment [Member] | ||
Debt Instrument [Line Items] | ||
Deferred financing costs | $ 0 | |
Debt instrument, fee amount | $ 76,000 | |
2018 Term Loan | ||
Debt Instrument [Line Items] | ||
Debt instrument repayment fee amount, paid | 2,200,000 | |
Debt instrument prepayment fee paid | $ 2,300,000 |
Loan Agreements (Solar Capita_2
Loan Agreements (Solar Capital 2019 Loan Agreement) (Narrative) (Details) - Solar Capital Ltd. - USD ($) $ in Thousands | Jan. 05, 2018 | Dec. 31, 2019 | Feb. 21, 2020 |
2019 Solar Loan Agreement | |||
Line of Credit Facility [Line Items] | |||
Line of credit maximum borrowing capacity | $ 45,000 | ||
Line of credit | 42,500 | $ 2,500 | |
Debt instrument repayment fee amount, paid | 2,250 | ||
Fee that will be due upon repayment of the term loan | 76 | ||
2018 Term Loan | |||
Line of Credit Facility [Line Items] | |||
Line of credit maximum borrowing capacity | 40,000 | ||
Debt instrument repayment fee amount, paid | 2,200 | ||
Debt instrument prepayment fee paid | $ 2,300 | ||
Exit Fee Agreement | 2018 Term Loan | |||
Line of Credit Facility [Line Items] | |||
Debt instrument, term | 10 years | ||
Debt instrument, exit fee | $ 2,000 |
Earnings (Loss) Per Sare (EPS)
Earnings (Loss) Per Sare (EPS) (Narrative) (Details) | Nov. 14, 2019 |
Earnings (Loss) Per Sare (EPS) [Abstract] | |
Reverse stock split conversion ratio | 15 |
Earnings (Loss) Per Sare (EPS_2
Earnings (Loss) Per Sare (EPS) (Antidilutive Securities Excluded from the Computation of Diluted Earnings Per Share) (Details) - shares | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,368,958 | 2,314,742 |
Series A convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 601,504 | 601,504 |
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) | 576,669 | 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) | 119,712 | 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) | 1,040,987 | 880,096 |
Restricted Stock and RSUs | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 30,086 | 36,763 |
Preferred Stock (Narrative) (De
Preferred Stock (Narrative) (Details) - shares | Aug. 28, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Common Stock | |||
Conversion of Stock [Line Items] | |||
Shares issued in conversion of preferred stock (in shares) | 99,999 | ||
Series C convertible preferred stock | |||
Conversion of Stock [Line Items] | |||
Shares issued in conversion of preferred stock (in shares) | 1,499.967 | ||
Preferred stock, shares issued (in shares) | 8,650.033 | 10,150 | |
Preferred stock, shares outstanding (in shares) | 8,650.033 | 10,150 | |
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 |
Stock Incentive Plans (Narrativ
Stock Incentive Plans (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average contractual term | 4 years 11 months 1 day | 5 years 14 days | |||
Exercise of stock options (in shares) | |||||
Stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average contractual term | 2 years 3 months 7 days | ||||
Share-based compensation not yet recognized | $ 1,716 | $ 1,716 | |||
Share-based compensation expense | $ 282 | $ 408 | $ 853 | $ 1,470 | |
Omnibus Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for grant (in shares) | 239,565 | 239,565 | |||
Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | $ 13 | 6 | $ 51 | 17 | |
Restricted Stock and RSUs | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based compensation expense | 22 | $ 90 | 170 | $ 416 | |
Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized share based compensation expense | $ 47 | $ 47 | |||
Weighted average period | 5 months 8 days |
Stock Incentive Plans (Summary
Stock Incentive Plans (Summary of Stock Option Transactions) (Details) - $ / shares | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Options | |||||
Options outstanding at beginning of period (in shares) | 1,043,297 | 912,430 | 871,472 | 830,100 | |
Grants (in shares) | 2,450 | 5,412 | 198,731 | 126,948 | |
Forfeitures (in shares) | (4,760) | (37,748) | (29,216) | (76,954) | |
Exercises (in shares) | |||||
Options outstanding at year end (in shares) | 1,040,987 | 880,094 | 1,040,987 | 880,094 | |
Options exercisable at year end (in shares) | 764,151 | 648,880 | 764,151 | 648,880 | 674,952 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 3.48 | $ 7.65 | $ 4.17 | $ 8.34 | |
Weighted Average Exercise Price ($) | |||||
Options outstanding at beginning of period (usd per share) | 29.84 | 36.04 | 35.46 | 39.41 | |
Grants (usd per share) | 5.46 | 12.65 | 6.70 | 13.45 | |
Forfeitures (usd per share) | 28.29 | 47.34 | 42 | 42.31 | |
Exercises (usd per share) | |||||
Options outstanding at year end (usd per share) | 29.79 | 35.41 | 29.79 | 35.41 | |
Options exercisable at year end (usd per share) | $ 36.91 | $ 42.25 | $ 36.91 | $ 42.25 | $ 41.25 |
Stock Incentive Plans (Addition
Stock Incentive Plans (Additional Stock Option Transactions) (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Dec. 31, 2018 | |
Outstanding Stock Options | ||||||
Outstanding, shares (in shares) | 1,040,987 | 871,472 | 1,043,297 | 880,094 | 912,430 | 830,100 |
Outstanding, weighted average exercise price (usd per share) | $ 29.79 | $ 35.46 | $ 29.84 | $ 35.41 | $ 36.04 | $ 39.41 |
Outstanding, weighted average remaining contractual term | 5 years 11 months 8 days | 5 years 9 months 29 days | ||||
Outstanding, aggregate intrinsic value | $ 1 | $ 4 | ||||
Exercisable Stock Options | ||||||
Exercisable, shares (in shares) | 764,151 | 674,952 | 648,880 | |||
Exercisable, weighted average exercise price (usd per share) | $ 36.91 | $ 41.25 | $ 42.25 | |||
Exercisable, weighted average remaining contractual term | 4 years 11 months 1 day | 5 years 14 days | ||||
Exercisable and expected to vest | ||||||
Outstanding, vested and expected to vest, shares (in shares) | 1,007,268 | 849,285 | ||||
Outstanding, vested and expected to vest, weighted average exercise price (usd per share) | $ 30.48 | $ 36 | ||||
Outstanding, vested and expected to vest, weighted average remaining contractual term | 5 years 10 months 2 days | 5 years 9 months | ||||
Outstanding, vested and expected to vest, aggregate intrinsic value | $ 1 | $ 3 |
Stock Incentive Plans (Summar_2
Stock Incentive Plans (Summary of Restricted Stock and Restricted Stock Unit Transactions) (Details) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Restricted Stock & RSUs | ||||
Restricted stock units & RSUs outstanding at beginning of period (in shares) | 30,086 | 36,763 | 36,763 | 60,041 |
Grants (in shares) | 0 | 0 | 30,086 | 36,763 |
Vested units (in shares) | 0 | 0 | (36,763) | (60,041) |
Forfeitures (in shares) | 0 | 0 | ||
Restricted stock units outstanding at year end (in shares) | 30,086 | 36,763 | 30,086 | 36,763 |
Weighted Average Grant Date Fair Value ($) | ||||
Restricted stock units outstanding at beginning of period (usd per share) | $ 3.12 | $ 13.15 | $ 13.15 | $ 17.30 |
Grants (usd per share) | 0 | 0 | 3.12 | 13.15 |
Vested units (usd per share) | 0 | 0 | 13.15 | 17.29 |
Forfeitures (usd per share) | 0 | 0 | ||
Restricted stock units & RSUs outstanding at year end (usd per share) | $ 3.12 | $ 13.15 | $ 3.12 | $ 13.15 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | ||
Uncertain tax positions liability increase | $ 4,500 | |
Cumulative book losses in foreign subsidiaries | $ (134,379) | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | 125,756 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | $ 172,993 |
Segment Information (Summary of
Segment Information (Summary of Operations by Segment) (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2020USD ($)customer | Sep. 30, 2019USD ($)customer | Sep. 30, 2020USD ($)customer | Sep. 30, 2019USD ($)customer | Dec. 31, 2019customer | |
Segment Reporting Information [Line Items] | |||||
NET REVENUE | $ 12,473 | $ 12,850 | $ 37,046 | $ 36,595 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,537) | (1,579) | (4,949) | (4,353) | |
GROSS PROFIT | 10,936 | 11,271 | 32,097 | 32,242 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 2,469 | 2,761 | 7,162 | 8,322 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 2,619 | 3,121 | 8,775 | 10,189 | |
SALES AND MARKETING EXPENSES | 4,764 | 6,437 | 14,818 | 18,458 | |
DEPRECIATION AND AMORTIZATION | 677 | 668 | 2,016 | 1,974 | |
OPERATING EXPENSES | 10,529 | 12,987 | 32,771 | 38,943 | |
NET INCOME (LOSS) FROM OPERATIONS | 407 | (1,716) | (674) | (6,701) | |
OTHER INCOME AND EXPENSES, NET | (1,018) | (1,347) | (3,633) | (3,831) | |
NET LOSS BEFORE TAXES | (611) | (3,063) | (4,307) | (10,532) | |
United States Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | 6,962 | 8,692 | 17,449 | 22,778 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (746) | (1,001) | (1,928) | (2,494) | |
GROSS PROFIT | 6,216 | 7,691 | 15,521 | 20,284 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,560 | 1,573 | 4,580 | 4,629 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 1,952 | 2,032 | 5,867 | 6,116 | |
SALES AND MARKETING EXPENSES | 3,461 | 4,502 | 10,948 | 12,760 | |
OPERATING EXPENSES | 6,973 | 8,107 | 21,395 | 23,505 | |
NET INCOME (LOSS) FROM OPERATIONS | $ (757) | $ (416) | $ (5,874) | $ (3,221) | |
United States Segment | Customer Concentration Risk | Sales | |||||
Segment Reporting Information [Line Items] | |||||
Number of customers | customer | 2 | 2 | 2 | 2 | |
Concentration risk percentage | 56.00% | 68.00% | 47.00% | 62.00% | |
United States Segment | Customer Concentration Risk | Accounts Receivable | |||||
Segment Reporting Information [Line Items] | |||||
Number of customers | customer | 2 | 2 | |||
Concentration risk percentage | 65.00% | 68.00% | |||
International Segment | |||||
Segment Reporting Information [Line Items] | |||||
NET REVENUE | $ 5,511 | $ 4,158 | $ 19,597 | $ 13,817 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (791) | (578) | (3,021) | (1,859) | |
GROSS PROFIT | 4,720 | 3,580 | 16,576 | 11,958 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 861 | 1,100 | 2,418 | 3,361 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 475 | 768 | 2,250 | 2,876 | |
SALES AND MARKETING EXPENSES | 1,226 | 1,840 | 3,618 | 5,324 | |
OPERATING EXPENSES | 2,562 | 3,708 | 8,286 | 11,561 | |
NET INCOME (LOSS) FROM OPERATIONS | 2,158 | (128) | 8,290 | 397 | |
Other Segments | |||||
Segment Reporting Information [Line Items] | |||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 48 | 88 | 164 | 332 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 192 | 321 | 658 | 1,197 | |
SALES AND MARKETING EXPENSES | 77 | 95 | 252 | 374 | |
DEPRECIATION AND AMORTIZATION | 677 | 668 | 2,016 | 1,974 | |
OPERATING EXPENSES | 994 | 1,172 | 3,090 | 3,877 | |
NET INCOME (LOSS) FROM OPERATIONS | (994) | (1,172) | (3,090) | (3,877) | |
OTHER INCOME AND EXPENSES, NET | $ (1,018) | $ (1,347) | $ (3,633) | $ (3,831) |