Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 28, 2018 | Jun. 30, 2017 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | ALIMERA SCIENCES INC | ||
Entity Central Index Key | 1,267,602 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Smaller Reporting Accelerated Filer | ||
Entity Public Float | $ 81,912,112 | ||
Entity Common Stock, Shares Outstanding | 69,985,666 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 24,067 | $ 30,979 |
Restricted cash | 34 | 31 |
Accounts receivable, net | 11,435 | 13,839 |
Prepaid expenses and other current assets | 2,278 | 2,107 |
Inventory | 1,508 | 446 |
Total current assets | 39,322 | 47,402 |
Property and equipment, net | 1,410 | 1,787 |
Intangible asset, net | 18,664 | 20,604 |
Deferred tax asset | 528 | |
Deferred tax asset, noncurrent | 436 | |
TOTAL ASSETS | 59,924 | 70,229 |
CURRENT LIABILITIES: | ||
Accounts payable | 5,905 | 4,986 |
Accrued expenses | 3,582 | 3,758 |
Derivative warrant liability | 0 | 188 |
Capital lease obligations | 184 | 191 |
Total current liabilities | 9,671 | 9,123 |
NON-CURRENT LIABILITIES: | ||
Note payable | 34,365 | 33,084 |
Capital lease obligations — less current portion | 203 | 274 |
Other non-current liabilities | 766 | 2,162 |
COMMITMENTS AND CONTINGENCIES (Note 10) | ||
STOCKHOLDERS’ EQUITY: | ||
Additional paid-in capital | 341,622 | 330,781 |
Accumulated deficit | (399,075) | (377,074) |
Accumulated other comprehensive loss — foreign currency translation adjustments | (821) | (1,272) |
TOTAL STOCKHOLDERS’ EQUITY | 14,919 | 25,586 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 59,924 | 70,229 |
Preferred Stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | ||
Series A convertible preferred stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | 19,227 | 19,227 |
Series B convertible preferred stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | 49,568 | 49,568 |
Common Stock | ||
STOCKHOLDERS’ EQUITY: | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 69,146,381 shares issued and outstanding at December 31, 2017 and 64,862,904 shares issued and outstanding at December 31, 2016 | 691 | 649 |
Common stock warrants | $ 3,707 | $ 3,707 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 69,146,381 | 64,862,904 |
Common stock, shares outstanding | 69,146,381 | 64,862,904 |
Series A convertible preferred stock | ||
Preferred stock, shares authorized | 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 | $ 24,000,000 | $ 24,000,000 |
Series B convertible preferred stock | ||
Preferred stock, shares authorized | 8,417 | 8,417 |
Preferred stock, shares issued (in shares) | 8,416.251 | 8,416.251 |
Preferred stock, shares outstanding (in shares) | 8,416.251 | 8,416.251 |
Preferred stock, liquidation preference | $ 50,750,000 | $ 50,750,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Statement [Abstract] | ||
NET REVENUE | $ 35,912 | $ 34,333 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (3,438) | (2,344) |
GROSS PROFIT | 32,474 | 31,989 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 12,844 | 12,375 |
GENERAL AND ADMINISTRATIVE EXPENSES | 13,039 | 15,263 |
SALES AND MARKETING EXPENSES | 23,210 | 29,431 |
DEPRECIATION AND AMORTIZATION | 2,684 | 2,767 |
RECOVERABLE COLLABORATION COSTS | (2,851) | 0 |
OPERATING EXPENSES | 48,926 | 59,836 |
NET LOSS FROM OPERATIONS | (16,452) | (27,847) |
INTEREST EXPENSE AND OTHER | (5,579) | (5,178) |
UNREALIZED FOREIGN CURRENCY GAIN (LOSS), NET | 5 | (40) |
LOSS ON EARLY EXTINGUISHMENT OF DEBT | 0 | (2,564) |
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | 188 | 2,627 |
NET LOSS BEFORE TAXES | (21,838) | (33,002) |
PROVISION FOR TAXES | (163) | (172) |
NET LOSS | $ (22,001) | $ (33,174) |
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS — Basic and diluted (in dollars per share) | $ (0.33) | $ (0.63) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted (in shares) | 66,993,649 | 52,801,603 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (22,001) | $ (33,174) |
OTHER COMPREHENSIVE INCOME (LOSS) | ||
Foreign currency translation adjustments | 451 | (124) |
TOTAL OTHER COMPREHENSIVE INCOME (LOSS) | 451 | (124) |
COMPREHENSIVE LOSS | $ (21,550) | $ (33,298) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock Issued | Common Stock | Common StockCommon Stock Issued | Preferred StockSeries A Convertible Preferred Stock | Preferred StockSeries B Convertible Preferred Stock | Additional Paid-In Capital | Additional Paid-In CapitalCommon Stock Issued | Common Stock Warrants | Accumulated Deficit | Accumulated Other Comprehensive Loss |
BALANCE at Dec. 31, 2015 | $ 26,320 | $ 450 | $ 19,227 | $ 49,568 | $ 299,376 | $ 2,747 | $ (343,900) | $ (1,148) | |||
BALANCE (in shares) at Dec. 31, 2015 | 45,005,833 | 600,000 | 8,416 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of stock, net of issuance costs | $ 26,422 | $ 197 | $ 26,225 | ||||||||
Issuance of stock, net of issuance costs (in shares) | 19,645,539 | ||||||||||
Exercise of stock options | $ 293 | $ 2 | 291 | ||||||||
Exercise of stock options (in shares) | 285,231 | 211,532 | |||||||||
Modification of common stock warrants | $ 590 | 590 | |||||||||
Issuance of common stock warrants | 370 | 370 | |||||||||
Stock-based compensation | 4,889 | 4,889 | |||||||||
Net loss | (33,174) | (33,174) | |||||||||
Foreign currency translation adjustments | (124) | (124) | |||||||||
BALANCE at Dec. 31, 2016 | 25,586 | $ 649 | $ 19,227 | $ 49,568 | 330,781 | 3,707 | (377,074) | (1,272) | |||
BALANCE (in shares) at Dec. 31, 2016 | 64,862,904 | 600,000 | 8,416 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of stock, net of issuance costs | $ 5,901 | $ 42 | $ 5,859 | ||||||||
Issuance of stock, net of issuance costs (in shares) | 4,282,748 | ||||||||||
Exercise of stock options | $ 1 | $ 0 | 1 | ||||||||
Exercise of stock options (in shares) | 729 | 729 | |||||||||
Stock-based compensation | $ 4,981 | 4,981 | |||||||||
Net loss | (22,001) | (22,001) | |||||||||
Foreign currency translation adjustments | 451 | 451 | |||||||||
BALANCE at Dec. 31, 2017 | $ 14,919 | $ 691 | $ 19,227 | $ 49,568 | $ 341,622 | $ 3,707 | $ (399,075) | $ (821) | |||
BALANCE (in shares) at Dec. 31, 2017 | 69,146,381 | 600,000 | 8,416 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (22,001) | $ (33,174) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 2,684 | 2,767 |
Inventory reserve | 34 | 104 |
Unrealized foreign currency transaction loss | (5) | 40 |
Amortization of debt discount | 1,416 | 1,038 |
Deferred taxes (benefit) | (92) | (213) |
Loss on early extinguishment of debt | 0 | 2,564 |
Stock compensation expense | 4,981 | 4,889 |
Change in fair value of derivative warrant liability | (188) | (2,627) |
Changes in assets and liabilities: | ||
Accounts receivable | 2,610 | (4,096) |
Prepaid expenses and other current assets | (67) | 556 |
Inventory | (1,052) | 1,000 |
Accounts payable | 644 | 1,073 |
Accrued expenses and other current liabilities | (271) | 1,035 |
Other long-term liabilities | (1,567) | (55) |
Net cash used in operating activities | (12,874) | (25,099) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (238) | (186) |
Net cash used in investing activities | (238) | (186) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of stock options | 1 | 292 |
Proceeds from sale of common stock | 6,084 | 27,763 |
Payment of issuance cost of common stock | (183) | (1,341) |
Payment of debt issuance costs (Note 9) | 0 | (1,069) |
Payments on capital lease obligations | (182) | (227) |
Changes in restricted cash | 3 | 6 |
Net cash provided by financing activities | 5,723 | 25,424 |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS | 477 | (235) |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (6,912) | (96) |
CASH AND CASH EQUIVALENTS — Beginning of year | 30,979 | 31,075 |
CASH AND CASH EQUIVALENTS — End of year | 24,067 | 30,979 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 4,117 | 3,958 |
Cash paid for income taxes | 74 | 193 |
Supplemental schedule of noncash investing and financing activities: | ||
Property and equipment acquired under capital leases | 282 | 76 |
Note payable end of term payment accrued but unpaid | $ 1,400 | $ 1,400 |
Nature of Operations
Nature of Operations | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization, research and development of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware. The Company is presently focused on diseases affecting the back of the eye, or retina, because the Company’s management believes these diseases are not well treated with current therapies and represent a significant market opportunity. The Company’s only commercial product is ILUVIEN ® , which has received marketing authorization in the United States (U.S.), Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden and the United Kingdom. In the U.S., ILUVIEN is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). In the European Economic Area (EEA) countries in which ILUVIEN has received marketing authorization, it is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available therapies. As part of the approval process in Europe, the Company committed to conduct a five -year, post-authorization, open label registry study in 800 patients treated with ILUVIEN. In the fourth quarter of 2016, the Company requested approval to modify its protocol to cap enrollment in the study due to its post market safety surveillance not showing any unexpected safety signals. The Company received regulatory approval to cap enrollment in the study from the Medicines & Healthcare products Regulatory Agency (MHRA) in July 2017. As of December 31, 2017, 562 patients were enrolled in this study. The Company commercially markets ILUVIEN in the U.S., Germany, the United Kingdom, Portugal, Austria and Ireland. The Company began selling ILUVIEN in Austria in the first quarter of 2017 and in Ireland in the fourth quarter of 2017. In addition, the Company has entered into various agreements under which distributors will provide regulatory, reimbursement or sales and marketing support for future commercialization of ILUVIEN in several countries in the Middle East, as well as France, Italy, Spain, Australia, New Zealand and Canada. In the third quarter of 2016, the Company’s Middle East distributor launched ILUVIEN and initiated named patient sales in the United Arab Emirates. The Company’s Italian distributor launched ILUVIEN in Italy in the second quarter of 2017. As of December 31, 2017, the Company has recognized sales of ILUVIEN to the Company’s distributors in the Middle East, Italy and Spain. In July 2017, the Company amended its license with pSivida US, Inc. (pSivida) for the technology underlying ILUVIEN to include the treatment of uveitis, including non-infectious posterior uveitis (NIPU) in Europe, the Middle East and Africa (Note 8). Uveitis is an inflammatory disease of the uveal tract, which is comprised of the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. In December 2017, the Company filed an application for a new indication for ILUVIEN for NIPU in the 17 EEA countries where ILUVIEN is currently approved for the treatment of DME. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates in Financial Statements — The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates. Principles of Consolidation — The consolidated financial statements include the accounts of Alimera Sciences, Inc. and all wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation. Cash, Cash Equivalents and Restricted Cash — Cash equivalents include highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash and cash equivalents held at financial institutions are in excess of federally insured limits. Cash and cash equivalents were $24,067,000 and $30,979,000 as of December 31, 2017 and 2016, respectively, with approximately 93.0% and 92.0% of these balances, respectively held in U.S. based financial institutions. In addition, under its loan and security agreement with Hercules Capital, Inc. (Hercules), the Company was required to maintain minimum balances in specific bank accounts as collateral which are recorded as restricted cash (see Note 9). Product Revenue — The Company recognizes revenue from its product sales when persuasive evidence of an arrangement exists, title to product and associated risk of loss have passed to the customer, the price is fixed or determinable, and collection from the customer is reasonably assured. Title passes generally upon receipt by the customer. Precise information regarding the receipt of product by the customer is not always readily available. In these cases, the Company estimates the date of receipt based upon shipping policies by geographic location. The Company ’ s shipping policies require delivery within 24 hours of shipment in most instances. Taxes that are collected from customers and remitted to governmental authorities, primarily in Europe, are not included in revenue. In the U.S., the Company sells ILUVIEN to a limited number of pharmaceutical distributors who in turn sell the product downstream to pharmacies and physician practices. Revenue is recorded net of provisions for estimated rebates, wholesaler chargebacks, distribution related fees, and other deductions. Calculating these provisions involves management’s estimates and judgments. The Company reviews its estimates of rebates, chargebacks and other applicable provisions each period and records any necessary adjustments in the current period’s net product sales. In the international segment, the Company sells ILUVIEN to hospitals, pharmacies and physician practices. Revenue is recorded net of provisions for contractual rebates, cash discounts, and other deductions. Additionally, in the international segment, the Company recognizes royalties from corporate partners based on third-party sales of ILUVIEN, and these royalties are recorded in accordance with contract terms when third-party results are reliably measurable and collectability is reasonably assured. Corporate partner revenues are composed mainly of royalties, license fees, and milestones earned. Accounts Receivable and Allowance for Doubtful Accounts — Accounts receivable are generated through sales primarily to pharmacies, hospitals and wholesalers. The Company does not require collateral from its customers for accounts receivable. The carrying amount of accounts receivable is reduced by an allowance for doubtful accounts that reflects management ’ s best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. Provisions for doubtful accounts are charged to operations at the time management determines these accounts may become uncollectable. The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. As of December 31, 2017 and 2016, the Company had no reserve for doubtful accounts. Inventory — Inventories are stated at the lower of cost or market with cost determined under the first in, first out (FIFO) method. Included in inventory costs are component parts, work-in-progress and finished goods. The Company relies on third party manufacturers for the production of all inventory and does not capitalize any internal costs. The Company periodically reviews inventories for excess, obsolete or expiring inventory and writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Intangible Assets — The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The Company estimated the useful life of its intangible asset at approximately thirteen years (see Note 6). Property and Equipment — Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture, fixtures and manufacturing equipment, five years ; automobiles, four years ; software and information technology hardware, three years ; and office equipment and leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease life. Impairment — Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. Income Taxes — The Company provides for income taxes based on pretax income and applicable tax rates available in the various jurisdictions in which it operates. Significant judgment is required in determining the provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount of future tax benefit that is more likely than not to be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company recognizes both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. Research and Development Costs — Research and development costs are expensed as incurred. Research and development expenses were $4,216,000 and $2,146,000 for the years ended December 31, 2017 and 2016, respectively. During the year ended December 31, 2017, the Company expensed $2,851,000 of in-process Research and Development Expense in connection with the New Collaboration Agreement (see Note 8). Stock-Based Compensation — The Company has stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock units (RSUs) and stock options. The fair values of RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over a service period, net of estimated forfeitures. Compensation expense is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 718, Compensation — Stock Compensation . The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model. Additionally, the Company sponsors an employee stock purchase plan (ESPP) under which employees may elect payroll withholdings to fund purchases of the Company’s stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company’s common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans . Derivative Financial Instruments — The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks. However, certain warrants to purchase Series A Convertible Preferred Stock or common stock that do not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the ASC, were classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants were considered derivative instruments at issuance because the agreements provide for settlement in Series A Convertible Preferred Shares or common shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future and contain anti-dilution provisions whereby the number of shares for which the warrants are exercisable and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. The warrant exercise price no longer can be adjusted at some point in the future. The primary underlying risk exposure pertaining to the warrants is the change in fair value of the underlying common stock. Such financial instruments are initially recorded at fair value with subsequent changes in fair value recorded as a component of change in fair value of derivative warrant liability in the consolidated statements of operations in each reporting period. If these instruments subsequently meet the requirements for equity classification, the Company reclassifies the fair value to equity. As of December 31, 2016, these warrants represented the only outstanding derivative instruments issued or held by the Company. The rights to exercise these warrants expired on October 1, 2017. Fair Value of Financial Instruments — The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company’s notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Foreign Currency Translation — The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using applicable exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in Accumulated other comprehensive loss . The earnings of these subsidiaries are translated into U.S. dollars using average exchange rates. Earnings Per Share (EPS) — Basic EPS is calculated in accordance with ASC 260, Earnings per Share by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average common shares outstanding for the dilutive effect of common stock options, warrants, convertible preferred stock and accrued but unpaid convertible preferred stock dividends. 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 to do so would have been anti-dilutive, were as follows: Years Ended December 31, 2017 2016 Series A convertible preferred stock 9,022,556 9,022,556 Series B convertible preferred stock 8,416,251 8,416,251 Series A convertible preferred stock warrants — 4,511,279 Common stock warrants 1,795,663 1,795,663 Stock options 11,595,510 10,804,412 Restricted stock units 839,285 — Total 31,669,265 34,550,161 Reporting Segments — The Company determines segments in accordance with its internal operating structure. 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 and regulatory environment. Each segment is separately managed and is evaluated primarily on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. The Company does not report balance sheet information by segment since it is not reviewed by the Company’s chief operating decision maker. The Company has three reportable segments, U.S., International and Other. Modification of Segment Footnote — The Company modified its segment footnote for the year ended December 31, 2016 for an immaterial change and removed, within the segment footnote, certain non-cash expenses including $4,889,000 of stock-based compensation expense and $2,767,000 of depreciation and amortization from the Company’s U.S. and International segments. These amounts are appropriately classified as Other within the segment footnote of these consolidated financial statements. Additionally, in the Company’s Annual Report on Form 10-K filing for the year ended December 31, 2016, the Company disclosed that the Company’s chief operating decision maker separately managed and evaluated each segment primarily upon net loss from operations. The modification made in these consolidated financial statements clarifies that the chief operating decision maker manages and evaluates each segment based on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. Adoption of New Accounting Standards — In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern . ASU 2014-15 requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued and provides guidance on determining when and how to disclose going concern uncertainties in the financial statements. ASU 2014-15 applies to all entities and is effective for annual and interim reporting periods ending after December 15, 2016, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements. In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory . This update requires entities to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. This ASU is effective for annual reporting periods beginning after December 15, 2016 and interim periods within those years. The adoption of this guidance did not have a material impact on the Company’s financial statements. In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments (Topic 230) . ASU 2016-15 is intended to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows and to eliminate the diversity in practice related to such classifications. The standard is effective for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230) - Restricted Cash . ASU 2016-18 requires a statement of cash flows to explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective — In May 2014, the Financial Accounting Standards Board (FASB) issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) that amends the guidance for the recognition of revenue from contracts with customers to transfer goods and services. The FASB has subsequently issued additional, clarifying standards to address issues arising from implementation of the new revenue recognition standard. The new revenue recognition standard and clarifying standards are effective for interim and annual periods beginning on January 1, 2018. The new standards are required to be adopted using either a full-retrospective or a modified-retrospective approach. We will adopt these standards using the modified-retrospective approach beginning in 2018. We have completed our impact assessment and do not anticipate a material impact to net revenue in our Consolidated Statements of Operations, accounting policies, business processes, internal controls or disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . This standard requires all leases with durations greater than twelve months to be recognized on the balance sheet and is effective for interim and annual reporting periods beginning after December 15, 2018, although early adoption is permitted. The primary effect of adoption will be the requirement to record right-of-use assets and corresponding lease obligations for current operating leases. In addition, the standard will require that we update our systems, processes and controls we use to track, record and account for our lease portfolio. The Company is currently in the process of evaluating the impact of the adoption on the Company’s financial statements. |
Going Concern
Going Concern | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
GOING CONCERN | GOING CONCERN The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. To date the Company has incurred recurring losses, negative cash flow from operations and has accumulated a deficit of $399,075,000 from the Company’s inception through December 31, 2017 . As of December 31, 2017 , the Company had approximately $24,067,000 in cash and cash equivalents. The Company’s ability to achieve profitability and positive cash flow depends on its ability to increase revenue and contain its expenses. During the year ended December 31, 2017, the Company raised $6,001,000 of additional equity via the Company’s at-the-market offering facility, which expired on August 13, 2017, for operations and to ensure compliance with its debt covenants. In management’s opinion, the uncertainty regarding the Company’s future revenues, and its ability to maintain compliance with its debt covenants raises doubt about the Company’s ability to continue as a going concern without access to alternate or additional debt or equity financing, over the course of the next twelve months. In particular, the Company must maintain compliance with the covenants of its debt agreement (see Note 9). To meet the Company’s future working capital needs, the Company may need to raise additional debt or equity financing. The Company may be able to access capital under the Company’s current at-the-market offering facility, which has $25,000,000 of remaining availability. While the Company has historically 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 in order to satisfy its obligations due within one year from the date of issuance of these financial statements, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity or increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these financial statements are issued. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following: December 31, 2017 2016 (In thousands) Component parts (1) $ 404 $ 115 Work-in-process (2) 587 18 Finished goods 517 313 Total inventory 1,508 446 (1) Component parts inventory consisted of manufactured components of the ILUVIEN applicator. (2) Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT Property and equipment consisted of the following: December 31, 2017 2016 (In thousands) Furniture and fixtures $ 392 $ 391 Office equipment 864 838 Automobiles 663 762 Software 1,122 973 Leasehold improvements 482 460 Manufacturing equipment 1,088 997 Total property and equipment 4,611 4,421 Less accumulated depreciation and amortization (3,201 ) (2,634 ) Property and equipment — net $ 1,410 $ 1,787 Depreciation and amortization expense associated with property and equipment totaled $744,000 and $822,000 for the years ended December 31, 2017 and 2016 , respectively. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | INTANGIBLE ASSET As a result of the U.S. Food and Drug Administration ’ s (FDA) approval of ILUVIEN in September 2014, the Company was required to pay pSivida a milestone payment of $25,000,000 (the pSivida Milestone Payment) in October 2014 (see Note 8). The gross carrying amount of the intangible asset is $25,000,000 , which is being amortized over approximately 13 years from the acquisition date. The net book value of the intangible asset was $18,664,000 and $20,604,000 as of December 31, 2017 and 2016, respectively, and amortization expense was $1,940,000 and $1,946,000 for the years ended December 31, 2017 and 2016, respectively. The estimated remaining amortization as of December 31, 2017 is as follows (in thousands): Years Ending December 31 2018 $ 1,940 2019 1,940 2020 1,946 2021 1,940 2022 1,940 Thereafter 8,958 Total $ 18,664 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2017 2016 (In thousands) Accrued clinical investigator expenses $ 696 $ 1,122 Accrued compensation expenses 511 1,020 Accrued rebate, chargeback and other revenue reserves 305 809 Accrued End of Term Payment (see Note 9) 1,400 — Other accrued expenses 670 807 Total accrued expenses $ 3,582 $ 3,758 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AGREEMENTS | LICENSE AGREEMENTS pSivida Agreement The Company entered into an agreement with pSivida for the use of fluocinolone acetonide (FAc) in pSivida’s proprietary insert technology in February 2005. This agreement was subsequently amended a number of times (as amended, the pSivida Agreement). The pSivida Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. 2008 Amended and Restated Collaboration Agreement Pursuant to the payment terms of the 2008 Amended and Restated Agreement (the 2008 Agreement), the Company was required to share 20% of the net profits of ILUVIEN, determined on a cash basis, and 33% of any lump sum milestone payments received from a sub-licensee of ILUVIEN, as defined by the 2008 Agreement. In connection with the 2008 Agreement, the Company was entitled to recover 20% of commercial losses associated with ILUVIEN, as defined in the pSivida Agreement, that could be offset in any future quarter out of payments of pSivida’s share of net profits (the Future Offset). As of December 31, 2016, the total Future Offsets available to reduce future net profit payments to pSivida, as defined in the 2008 Agreement, was $24,475,000 . In connection with the New Collaboration Agreement discussed below, the Company and pSivida agreed to cap the Future Offset amount as of June 30, 2017 at $25,000,000 . The Future Offset was not previously reflected on the Company’s balance sheet due to the uncertainty of future realizability. New Collaboration Agreement - Second Amended and Restated Collaboration Agreement On July 10, 2017, the Company and pSivida entered into a Second Amended and Restated Collaboration Agreement (the New Collaboration Agreement), which amends and restates the pSivida Agreement. Prior to entering into the New Collaboration Agreement, the Company held the worldwide license from pSivida for the use of pSivida’s proprietary insert technology for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement expands the license to include uveitis, including NIPU, in Europe, the Middle East and Africa and allows the Company to also pursue an indication for posterior uveitis for ILUVIEN in those territories. The New Collaboration Agreement converts the Company’s obligation to share 20% of its net profits to a royalty payable on global net revenues of ILUVIEN. The Company began paying a 2% royalty on net revenues and other related consideration to pSivida July 1, 2017. This royalty amount will increase to 6% upon the earliest of December 12, 2018 or the receipt of the first marketing approval for ILUVIEN for the treatment of NIPU. The Company will pay an additional 2% royalty on global net revenues and other related consideration in excess of $75,000,000 in any year. During the year ended December 31, 2017, the Company recognized approximately $621,000 of royalty and profit share expense, which is included in cost of goods sold, excluding depreciation and amortization. As of December 31, 2017, approximately $184,000 of this royalty and profit share expense was included in the Company’s accounts payable. During the year ended December 31, 2016, the Company recognized approximately $254,000 of profit share expense. The New Collaboration Agreement did not require an upfront cash payment by the Company. In connection with the New Collaboration Agreement, the Company agreed to forgive $10,000,000 of the total $25,000,000 of the Future Offset at the amendment date. Following the signing of the New Collaboration Agreement, the Company retains a right to recover up to the remaining $15,000,000 of the Future Offset. The Company will be able to recover up to $15,000,000 as a reduction of future royalties as follows: • In the first two years following the increase in royalty amount to 6% , the royalty will be reduced to 4% for net revenues and other related consideration up to $75,000,000 annually and 5% for net revenues and other related consideration in excess of $75,000,000 on an annual basis; and • Beginning with the third year following the increase in royalty amount to 6% , the royalty will be reduced to approximately 5.2% for net revenues and other related consideration up to $75,000,000 annually and to approximately 6.8% for net revenues and other related consideration in excess of $75,000,000 on an annual basis. The Company will forgive up to $5,000,000 of the remaining $15,000,000 of Future Offsets upon the earlier of the approval of ILUVIEN for posterior uveitis in any EU country or January 1, 2020, unless certain conditions under the New Collaboration Agreement are not met. If the amounts recoverable by the Company associated with the Future Offsets are less than $5,000,000 at that time, the Company will pay pSivida the difference in cash. The Company valued the transaction utilizing a present value analysis at approximately $2,851,000 . Because there was no approved indication for ILUVIEN for uveitis at the time, the Company expensed the $2,851,000 as a non-cash charge as in-process Research and Development Expense in the third quarter of 2017. The Company also recognized $2,851,000 for Recoverable Collaboration Costs for the value of the right of offset as a reduction of operating expenses. As a result, there was no impact on the Company’s operating loss or net loss for the year ended December 31, 2017. General Discussion of pSivida Agreement The Company’s license rights to pSivida’s proprietary insert technology could revert to pSivida if the Company were to (i) fail twice to cure its breach of an obligation to make certain payments to pSivida following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the pSivida Agreement within 30 days after notice of such breaches or such longer period (up to 90 days) as may be reasonably necessary if the breach cannot be cured within such 30 -day period; (iii) file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days; or (iv) notify pSivida in writing of its decision to abandon its license with respect to a certain product using pSivida’s proprietary insert technology. |
Loan Agreements
Loan Agreements | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
LOAN AGREEMENTS | LOAN AGREEMENTS Hercules Loan Agreement 2014 Loan Agreement In April 2014, Alimera Sciences Limited (Limited), a subsidiary of the Company, entered into a loan and security agreement (2014 Loan Agreement) with Hercules providing for a term loan of up to $35,000,000 (2014 Term Loan), which Limited and Hercules amended in November 2015 (the First Loan Amendment), March 2016 (the Second Loan Amendment), May 2016 (the Third Loan Amendment), October 2016 (the Fourth Loan Amendment) and May 2017 (the Fifth Loan Amendment and, collectively with the 2014 Loan Agreement, the First Loan Amendment, the Second Loan Amendment, the Third Loan Amendment and the Fourth Loan Amendment, the Hercules Term Loan Agreement). Under the 2014 Loan Agreement, Hercules made an advance in the initial principal amount of $10,000,000 to Limited at closing to provide Limited with additional working capital for general corporate purposes and to repay a 2013 term loan with Silicon Valley Bank. Hercules made an additional advance of $25,000,000 to Limited in September 2014, following the approval of ILUVIEN by the FDA to fund the pSivida Milestone Payment. The 2014 Loan Agreement provided for interest only payments through November 2015. Interest on the 2014 Term Loan accrued at a floating per annum rate equal to the greater of (i) 10.90% , or (ii) the sum of (A) 7.65% , plus (B) the prime rate. Following the interest only period the 2014 Term Loan was due and payable to Hercules in equal monthly payments of principal and interest through May 1, 2018. First Loan Amendment In November 2015, Limited and Hercules amended the 2014 Loan Agreement to extend the interest only payments through May 2017. In connection with the First Loan Amendment, Limited paid to Hercules an amendment fee of $262,500 and agreed to make an additional payment of $1,050,000 , equal to 3% of the 2014 Term Loan at the time of the final payment (End of Term Payment). Limited and the Company, on a consolidated basis with the Company’s other subsidiaries (the Consolidated Group), agreed to customary affirmative and negative covenants and events of default in connection with these arrangements. The occurrence of an event of default could result in the acceleration of Limited’s obligations under the Hercules Term Loan Agreement and an increase to the applicable interest rate and would have permitted Hercules to exercise remedies with respect to the collateral under the Hercules Term Loan Agreement. In connection with the First Loan Amendment, Limited agreed to covenants regarding certain revenue thresholds and a liquidity threshold. Second Loan Amendment In January 2016, the revenue threshold covenant was not met by the Consolidated Group and as a result, in March 2016, Limited and Hercules entered into the Second Loan Amendment, which further amended certain terms of the 2014 Loan Agreement. In conjunction with the Second Loan Amendment, Hercules waived this covenant violation. The Second Loan Amendment adjusted the revenue covenant to a rolling three-month calculation, first measured for the three months ended May 31, 2016. In addition, the Second Loan Amendment increased the liquidity covenant. Upon execution of the Second Loan Amendment, Limited paid Hercules an amendment fee of $350,000 and agreed to increase the End of Term Payment to $1,400,000 from $1,050,000 , which was scheduled to be paid in May 2018. The Company concluded that the Second Loan Amendment resulted in a substantial modification of the terms of debt when considered with the First Loan Amendment in accordance with the guidance in ASC 470-50, Debt . As a result, the Company accounted for the Second Loan Amendment as an extinguishment and recognized a loss on early extinguishment of debt of approximately $2,564,000 within the consolidated statement of operations for the year ended December 31, 2016. The loss on early extinguishment consisted primarily of the unamortized debt discount associated with the warrant and debt issuance costs incurred prior to the Second Loan Amendment, the incremental fair value of the warrant as a result of modifying the terms of the warrant and the debt issuance costs of $360,000 paid to Hercules for the Second Loan Amendment. Third Loan Amendment and July 2016 Waiver In May 2016, Limited and Hercules entered into the Third Loan Amendment to expand the definition of liquidity to allow for the inclusion of cash of up to $2,000,000 in bank accounts outside of the U.S. and the United Kingdom. In July 2016, Limited obtained a waiver of the requirements of the liquidity covenant (the Waiver) because the Consolidated Group was not in compliance with the liquidity covenant as of June 30, 2016. The Waiver cured the default of the liquidity covenant then existing under the Hercules Term Loan Agreement and decreased the liquidity requirement. In addition, the Waiver modified the three-month revenue covenant so that it was not measured at July 31, 2016 and reduced the three-month revenue target to be measured at August 31, 2016. Following execution of the Waiver, Limited incurred a weekly ticking fee equal to 0.05% multiplied by the outstanding principal amount through the closing of the Company’s public offering in August 2016 (Note 13), totaling $65,000 . Further, Limited paid Hercules a fee of $350,000 associated with the Waiver. Fourth Loan Amendment In October 2016, Limited entered into the Fourth Loan Amendment with Hercules, which further amended certain terms of the Hercules Term Loan Agreement. Pursuant to the terms of the Fourth Loan Amendment, Hercules agreed to provide up to an additional $10,000,000 to Limited with (i) the first $5,000,000 to have been available at Limited’s option through June 30, 2017 subject to (A) the Consolidated Group’s achievement of $12,000,000 in trailing three month net product revenue and (B) no event of default having occurred since October 20, 2016 (the Effective Date) and (ii) the second $5,000,000 to have been available at Limited’s option through December 31, 2017 subject to (X) the Consolidated Group’s achievement of $15,000,000 in trailing three month net product revenue, (Y) no event of default having occurred since the Effective Date and (Z) the prior $5,000,000 having been advanced to Limited (the Additional Advances and, together with the 2014 Term Loan, the Term Loan). The Consolidated Group did not achieve the trailing three-month net product revenue threshold prior to June 30, 2017 and as a result the additional $10,000,000 was not available to Limited. The Fourth Loan Amendment provided for interest only payments through November 30, 2018 (the Interest-Only Period). Pursuant to the Fourth Loan Amendment, interest on the Term Loan was to accrue at a floating per annum rate equal the greater of (i) 11.0% and (ii) the sum of (A) 11.0% plus (B) the prime rate as reported in The Wall Street Journal, or if not reported, the prime rate most recently reported in The Wall Street Journal, minus 3.5% . In addition to the interest described above, the principal balance of the Term Loan was to bear “payment-in kind” interest at the rate of 1.0% (PIK Interest), which PIK Interest was to be added to the outstanding principal balance of the Term Loan so as to increase the outstanding principal balance of the Term Loan on each payment date for the Term Loan, which amount was to be payable when the aggregate outstanding principal amount of the Term Loan matured. The Term Loan was scheduled to be due and payable to Hercules in 24 equal monthly payments of principal and interest following the Interest-Only Period beginning on December 1, 2018 and was to mature in full on November 1, 2020. The interest rate on the Hercules Term Loan Agreement was 12.0% as of December 31, 2017. Limited paid Hercules a facility charge of $337,500 and reimbursed Hercules for legal and diligence fees incurred in connection with the Fourth Loan Amendment, which provided that if Limited were to prepay the Term Loan, it would pay Hercules a prepayment penalty (i) if such amounts were prepaid in any of the first 12 months following the Effective Date, equal to 3.0% of the principal amount of the Term Loan being repaid, (ii) if such amounts were prepaid after 12 months but prior to 24 months following the Effective Date, equal to 2.0% of the principal amount of the Term Loan being repaid, and (iii) if such amounts were prepaid at any time thereafter, equal to 1.0% of the principal amount of the Term Loan being repaid. The Consolidated Group also agreed to customary affirmative and negative covenants, including, without limitation, covenants relating to minimum liquidity, minimum trailing six-month net revenue and adjusted EBITDA and events of default in connection with these arrangements. The occurrence of an event of default could have resulted in the acceleration of Limited’s obligations under the Hercules Term Loan Agreement, as amended by the Fourth Loan Amendment and an increase to the applicable interest rate and would permit Hercules to exercise remedies with respect to the collateral under the Hercules Term Loan Agreement, as amended by the Fourth Loan Amendment. In the event that the Company maintained $35,000,000 in liquidity, including cash and eligible accounts receivable, at the end of the month and had not been and was not in breach of the amended debt facility, the six-month trailing revenue covenant would have been waived for such month. Fifth Loan Amendment In May 2017, Limited entered into the Fifth Loan Amendment with Hercules, which further amended and clarified certain terms of the Hercules Term Loan Agreement. The amendment was not material. October 2017 Waiver For September 2017, the Consolidated Group did not meet the six-month revenue covenant required under the Hercules Term Loan Agreement. As a result, the Consolidated Group was required to demonstrate it had $35,000,000 in liquidity as of the last business day in September 2017. On the last business day in September 2017, the Consolidated Group was not able to demonstrate it had $35,000,000 in liquidity. However, the Consolidated Group was able to demonstrate that it had $35,000,000 in liquidity on the business day immediately before the last business day in September 2017, the first business day in October 2017 and the last business day in October 2017. As a result, Hercules waived the Company’s non-compliance with the $35,000,000 liquidity requirement at the end of September 2017. General Discussion of the Hercules Term Loan Agreement Pursuant to the Hercules Term Loan Agreement, Limited’s obligations to Hercules were secured by a first-priority security interest in substantially all of Limited’s assets, excluding intellectual property. Hercules also maintained a negative pledge on Limited’s intellectual property requiring Hercules’ consent prior to the sale of such intellectual property. The Company and certain of the Company’s other subsidiaries were guarantors of the obligations of Limited to Hercules under the Hercules Term Loan Agreement pursuant to separate guaranty agreements between Hercules and each of Limited and such subsidiaries (Guaranties). Pursuant to the Guaranties, the Company and these subsidiaries granted Hercules a first-priority security interest in substantially all of their respective assets excluding intellectual property. The Hercules Term Loan Agreement also placed limitations on the Company’s ability to declare or pay any dividend or distribution on any shares of capital stock. 2014 Warrant In connection with Limited entering into the 2014 Loan Agreement, the Company issued a warrant to Hercules to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share (the 2014 Warrant). Sixty percent of the 2014 Warrant was exercisable at the closing in April 2014 and the remaining forty percent became exercisable upon the funding of the additional $25,000,000 to Limited in September 2014. The Company agreed to amend the 2014 Warrant in connection with the First Loan Amendment to increase the number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. Upon entering into the Second Loan Amendment, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 862,069 and decrease the exercise price to $2.03 per share. In connection with the July 2016 Waiver, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. 2016 Warrant In connection with Limited entering into the Fourth Loan Amendment, the Company agreed to issue a new warrant to Hercules (the 2016 Warrant) to purchase up to 458,716 shares of the Company’s common stock at an exercise price of $1.09 per share, which was equal to $500,000 divided by the lowest volume-weighted average sale price for a share of the Company’s common stock reported over any ten consecutive trading days during the period commencing on and including September 23, 2016 and ending on the earlier to occur of (i) December 30, 2016 (inclusive of such date), and (ii) the second trading day immediately preceding the date of closing of a merger event (as defined in the 2016 Warrant). Solar Capital Loan Agreement On January 5, 2018, the Company entered into a $40,000,000 Loan and Security Agreement (2018 Loan Agreement) with Solar Capital Ltd. (Solar Capital), as Collateral Agent (Agent), and the parties signing the 2018 Loan Agreement from time to time as Lenders, including Solar in its capacity as a Lender (each a “Lender” and collectively, the “Lenders”). Under the 2018 Loan Agreement, the Company borrowed the entire $40,000,000 as a term loan that matures on July 1, 2022. The Company used the proceeds of the term loan to refinance the Hercules Term Loan Agreement and expenses. The Company expects to use the remaining loan proceeds to provide additional working capital for general corporate purposes. Interest on the 2018 Loan Agreement is payable at one-month LIBOR plus 7.65% per annum. The 2018 Loan Agreement provides for interest only payments for the first 30 months ending on July 1, 2020, followed by 24 months of payments of principal and interest. If the Company meets certain revenue thresholds and no event of default shall have occurred and is continuing, the Company can extend the interest only period an additional six months ending on January 1, 2021, followed by 18 months of payments of principal and interest. As part of the fees and expenses incurred in conjunction with the 2018 Loan Agreement discussed above, the Company paid Solar Capital a $400,000 fee at closing. The Company is obligated to pay a $1,800,000 fee upon repayment of the term loan in full ( $2,000,000 if the interest only period has been extended to 36 months). The Company may elect to prepay the outstanding principal balance of the 2018 Loan Agreement in increments of $10,000,000 or more. The Company must pay a prepayment premium upon any prepayment of the 2018 Loan Agreement before its maturity date, whether by mandatory or voluntary prepayment, acceleration or otherwise, equal to: a. 2.00% of the principal amount prepaid for a prepayment made on or after January 5, 2018 through and including January 5, 2019; b. 1.00% of the principal amount prepaid for a prepayment made after January 5, 2019 through and including January 5, 2020; and c. 0.50% of the principal amount prepaid for a prepayment made after January 5, 2020 and greater than 30 days before the maturity date. The Company is also obligated to pay additional fees under the Exit Fee Agreement (Exit Fee Agreement) dated as of January 5, 2018 by and among the Company, Solar as Agent, and the Lenders. The Exit Fee Agreement survives the termination of the 2018 Loan Agreement and has a term of 10 years. The Company is obligated to pay up to, but no more than, $2,000,000 in fees under the Exit Fee Agreement. Specifically, the Company is obligated to pay an exit fee of $2,000,000 on a “change in control” (as defined in the Exit Fee Agreement). To the extent that Alimera has not already paid the $2,000,000 fee, the Company is also obligated to pay a fee of $1,000,000 on achieving each of the following milestones: a. first, if the Company achieves revenues of $80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and b. second, if the Company achieves revenues of $100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner. As noted above, the total fees payable under the Exit Fee Agreement may not exceed $2,000,000 . No warrants were issued in connection with the 2018 Loan Agreement. The Company agreed, for itself and its subsidiaries, to customary affirmative and negative covenants and events of default in connection with the 2018 Loan Agreement. The occurrence of an event of default could result in the acceleration of the Company’s obligations under the 2018 Loan Agreement and an increase to the applicable interest rate, and would permit Solar to exercise remedies with respect to the collateral under the 2018 Loan Agreement. The Company’s obligations to Agent and the Lenders are secured by a first priority security interest in substantially all of the assets, excluding intellectual property, of the Company and its wholly owned subsidiary, Alimera Sciences (DE), LLC (Alimera DE), which is a guarantor of the loan, provided that only 65% of the voting interests in AS C.V., a Dutch subsidiary owned by the Company and Alimera DE, are pledged to the Lenders, and no assets or equity interests in the direct or indirect subsidiaries of AS C.V. are subject to the Lenders’ security interests. The Lender does, however, maintain a negative pledge on the property of the Company and all of its subsidiaries, including the Company’s intellectual property, requiring the Lender’s consent for any liens (other than typical permitted liens) on or the sale of such property. Fair Value of Debt As of December 31, 2017 and 2016, the weighted average interest rates of the Company’s notes payable approximate the rate at which the Company could obtain alternative financing and the fair value of the warrants that were issued in connection with the Company’s notes payable are immaterial. Therefore, the carrying amount of the notes approximated their fair value at December 31, 2017 and 2016. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Term Note Payable — Under the Hercules Term Loan Agreement (see Note 9), as of December 31, 2017 , the Company was obligated to make future minimum principal payments, excluding (a) PIK Interest and (b) the $1,400,000 End of Term Payment that was scheduled to be paid in May 2018, as follows (in thousands): Years Ending December 31 (In thousands) 2018 $ 1,300 2019 $ 16,526 2020 $ 17,174 Total $ 35,000 As of December 31, 2017 and 2016 , the Company had $363,000 and $336,000 accrued and unpaid interest payable under the Hercules Term Loan Agreement, respectively. On January 5, 2018, the Company used part of the proceeds of the 2018 Loan Agreement to repay (a) all outstanding principal, (b) all accrued and unpaid interest and (c) the $1,400,000 End of Term Payment owed under the Hercules Term Loan Agreement. Operating Leases — The Company leases office space and equipment under non-cancelable agreements accounted for as operating leases. The leases generally require that the Company pay taxes, maintenance and insurance. Management expects that in the normal course of business, leases that expire will be renewed or replaced by other leases. In August 2014, the Company signed a lease for office space in the U.S. through September 2021. In December 2014, Limited signed a lease for office space in the United Kingdom through December 24, 2024, although the lease is cancellable after December 17, 2019. The lease has a contingent escalation clause based on inflation beginning in 2020. The Company also leases office space in Germany and Portugal under leases that expire in June 2021 and March 2020, respectively. As of December 31, 2017 , a schedule by year of future minimum payments under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2018 $ 561 2019 533 2020 417 2021 301 Total $ 1,812 Rent expense under all operating leases totaled approximately $499,000 and $544,000 for the years ended December 31, 2017 and 2016 , respectively. Capital Leases — The Company leases equipment under capital leases. The property and equipment is capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. As of December 31, 2017 , a schedule by year of future minimum payments under capital leases, together with the present value of minimum lease payments, is as follows (in thousands): Years Ending December 31 (In thousands) 2018 262 2019 172 2020 95 Total 529 Less amount representing interest (30 ) Less amount representing executory costs (112 ) Present value of minimum lease payments 387 Less current portion (184 ) Non-current portion $ 203 Property and equipment under capital leases, which are included in property and equipment (Note 5), consisted of the following: December 31, 2017 2016 (In thousands) Automobiles $ 663 $ 762 Office equipment 63 63 Less accumulated depreciation (311 ) (342 ) Total $ 415 $ 483 Depreciation expense associated with property and equipment under capital leases was approximately $172,000 and $267,000 for the years ended December 31, 2017 and 2016 , respectively. Significant Agreements — In February 2010, the Company entered into an agreement with a third party manufacturer for the manufacture of the ILUVIEN implant, the assembly of the ILUVIEN applicator and the packaging of the completed ILUVIEN commercial product. The Company is responsible for supplying the ILUVIEN applicator and the active pharmaceutical ingredient. In accordance with the terms of the agreement, the Company must order at least 80% of the ILUVIEN units required in the U.S., Canada and the EEA from the third party manufacturer for an initial term of six years. The agreement initially had an initial six -year term and automatically renewed for successive one -year periods unless either party delivered written notice of non-renewal to the other at least 12 months prior to the end of the then current term. In February 2016, the Company and the third party manufacturer amended and restated this agreement to extend the term to five years, at which point it will automatically renew for successive one -year periods unless either party delivers notice of non-renewal to the other party at least 12 months prior to the end of the term or any renewal term. In May 2013, the Company entered into an agreement with the first of three contract research organizations (CROs) for clinical and data management services to be performed in connection with the five -year, post-authorization, open label registry study in patients treated with ILUVIEN per the labeled indication in the EEA. Since May of 2013, nine additional agreements have been entered into for work with these CROs. For the years ended December 31, 2017 and 2016 , the Company incurred $101,000 and $157,000 , respectively, of expense associated with these agreements. As of December 31, 2017 and 2016, $67,000 and $76,000 , respectively, is included in accrued expenses (Note 7). As of December 31, 2017, the Company expects to incur an additional $390,000 of expense associated with these agreements through December 31, 2019. Employment Agreements — The Company is party to employment agreements with five executives. The agreements generally provide for annual salaries, bonuses and benefits and for the “at-will” employment of such executives. Effective January 1, 2018, the Company is party to five agreements with salaries ranging from $338,000 to $600,000 . If any of the agreements are terminated by the Company without cause, or by the employee for good reason, as defined in the agreements, the Company will be liable for one year to 18 months of salary and benefits. Certain other employees have general employment contracts that include stipulations regarding confidentiality, Company property, severance in an event of change of control and miscellaneous items. |
Preferred Stock
Preferred Stock | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
PREFERRED STOCK | PREFERRED STOCK Series A Convertible Preferred Stock On October 2, 2012, the Company closed its preferred stock financing in which it sold units consisting of 1,000,000 shares of Series A Convertible Preferred Stock and warrants to purchase 300,000 shares of Series A Convertible Preferred Stock for gross proceeds of $40,000,000 , prior to the payment of approximately $560,000 of related issuance costs. Each share of Series A Convertible Preferred Stock, including any shares of Series A Convertible Preferred Stock issued upon exercise of the warrants, is convertible into shares of the Company’s common stock at any time at the option of the holder at the rate equal to $40.00 divided by $2.66 (Conversion Price). The initial Conversion Price was subject to adjustment based on certain customary price based anti-dilution adjustments. These adjustment features lapsed in September 2014. Each share of Series A Convertible Preferred Stock shall automatically be converted into shares of common stock at the then-effective Conversion Price upon the occurrence of the later to occur of both (i) the Company receives and publicly announces the approval by the FDA of the Company’s New Drug Application for ILUVIEN and (ii) the date on which the Company consummates an equity financing transaction pursuant to which the Company sells to one or more third party investors either (a) shares of common stock or (b) other equity securities that are convertible into shares of common stock and that have rights, preference or privileges, senior to or on a parity with, the Series A Convertible Preferred Stock, in each case having an as-converted per share of common stock price of not less than $10.00 and that results in total gross proceeds to the Company of at least $30,000,000 . The rights and preferences of Series A Convertible Preferred Stock also place limitations on the Company ’ s ability to declare or pay any dividend or distribution on any shares of capital stock. Each unit sold in the preferred stock financing included a warrant to purchase 0.30 shares of Series A Convertible Preferred Stock at an exercise price equal to $44.00 per share. At the election of the holder of a warrant, the warrant could have been exercised for the number of shares of common stock then issuable upon conversion of the Series A Convertible Preferred Stock that would otherwise be issued upon such exercise at the then-effective Conversion Price. These warrants were considered derivative instruments because the agreements provided for settlement in Series A Convertible Preferred Stock shares or common stock shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future, and contain anti-dilution provisions whereby the number of shares for which the warrants are exercisable and/or the exercise price of the warrants was subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. Therefore, the warrants were recorded as a liability at issuance. These adjustment features lapsed in September 2014. As of December 31, 2016, the fair market value of the warrants was estimated to be $188,000 . The Company recorded gains of $188,000 and $2,627,000 as a result of the change in fair value of the warrants during the years ended December 31, 2017 and 2016, respectively. The rights to exercise these warrants expired on October 1, 2017. In 2014, 6,015,037 shares of common stock were issued pursuant to the conversion of 400,000 shares of Series A Convertible Preferred Stock. As of December 31, 2017, there were 600,000 shares of Series A Convertible Preferred Stock issued and outstanding. Series B Convertible Preferred Stock On December 12, 2014, the Company closed a preferred stock financing in which it sold 8,291.873 shares of Series B Convertible Preferred Stock for a purchase price of $6,030 per share, or an aggregate purchase price of $50,000,000 , prior to the payment of approximately $432,000 of related issuance costs. The Company issued an additional 124.378 shares of Series B Convertible Preferred Stock as a subscription premium to the purchasers. Each share of Series B Convertible Preferred Stock is convertible into 1,000 shares of the Company’s common stock at any time at the option of the holder, provided that the holder will be prohibited from converting Series B Convertible Preferred Stock into shares of the Company’s common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.98% of the total number of shares of the Company’s common stock then issued and outstanding. The Series B Convertible Preferred Stock ranks junior to the Company’s existing Series A Convertible Preferred Stock and senior to the Company’s common stock, with respect to rights upon liquidation. The Series B Convertible Preferred Stock ranks junior to all existing and future indebtedness. Except as otherwise required by law (or with respect to approval of certain actions), the Series B Convertible Preferred Stock do not have voting rights. The Series B Convertible Preferred Stock is not redeemable at the option of the holder. The Series B Convertible Preferred Stock is not subject to any price-based or other anti-dilution protections and does not provide for any accruing dividends. The Company determined that the conversion option of the Series B Convertible Preferred Shares represented a beneficial conversion feature, as the conversion feature had intrinsic value to the holder on the commitment date as a result of the subscription premium. Therefore, the Company recorded a beneficial conversion feature of $750,000 as an increase in additional paid in capital. Because the Series B Convertible Preferred Stock was immediately convertible into common stock at the option of the holder at issuance, the Company immediately accreted the full value of the beneficial conversion feature to the carrying value of the Series B Convertible Preferred Stock on that date. |
Stock Incentive Plans
Stock Incentive Plans | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
STOCK INCENTIVE PLANS | STOCK INCENTIVE PLANS The Company has stock option and stock incentive plans which provide for grants of shares to employees and grants of options to employees and directors to purchase shares of the Company’s common stock at exercise prices generally equal to the fair values of such stock at the dates of grant. These plans include RSUs, stock options and an employee stock purchase plan (ESPP). Options granted to employees typically become exercisable over a four -year vesting period and have a ten -year contractual term. Initial options granted to directors typically vest over a four -year period and have a ten -year contractual term. Annual option grants to directors typically vest immediately and have a ten -year contractual term. Upon the exercise of stock options, the Company may issue the required shares out of authorized but unissued common stock or out of treasury stock at management’s discretion. A summary of stock option transactions under the plans are as follows: Years Ended December 31, 2017 2016 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 10,804,412 $ 3.22 9,475,890 $ 3.43 Grants 2,336,300 1.25 2,195,250 2.05 Forfeitures (1,544,473 ) 2.63 (581,497 ) 3.15 Exercises (729 ) 1.49 (285,231 ) 1.41 Options outstanding at year end 11,595,510 2.90 10,804,412 3.22 Options exercisable at year end 8,085,064 3.25 7,363,400 3.29 Weighted average per share fair value of options granted during the year $ 0.94 $ 1.55 The following table provides additional information related to outstanding stock options, fully vested stock options, and stock options expected to vest as of December 31, 2017 : Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 11,595,510 $ 2.90 6.60 years $ — Exercisable 8,085,064 3.25 5.68 years — Outstanding, vested and expected to vest 11,161,477 2.94 6.51 years — The Company estimated the fair value of options granted using the Black-Scholes option pricing model. Use of a valuation model requires the Company to make certain assumptions with respect to selected model inputs. Changes in these input variables would affect the amount of expense associated with equity-based compensation. Expected volatility is based on the historical volatility of the Company ’ s common shares over the expected term of the stock option grant. To estimate the expected term, the Company utilizes the “simplified” method for “plain vanilla” options as discussed within the SEC’s Statement of Accounting Bulletin 107. The Company intends to utilize the simplified method for the foreseeable future until more detailed information about exercise behavior will be more widely available. The risk-free interest rate is based on U.S. Treasury Daily Treasury Yield Curve Rates corresponding to the expected life assumed at the date of grant. Dividend yield is zero as there are no payments of dividends made or expected. The weighted-average assumptions used for option grants were as follows: Years Ended December 31, 2017 2016 Risk-free interest rate 2.06 % 1.57 % Volatility factor 90.49 % 93.54 % Grant date fair value of common stock options $ 0.94 $ 1.55 Weighted-average expected life 6.02 years 5.99 years Assumed forfeiture rate 10.00 % 10.00 % Employee stock-based compensation expense related to stock options recognized in accordance with ASC 718 was as follows: Years Ended December 31, 2017 2016 (In thousands) Sales and marketing $ 907 $ 1,109 Research, development and medical affairs 643 886 General and administrative 2,510 2,814 Total employee stock-based compensation expense $ 4,060 $ 4,809 As of December 31, 2017, there was approximately $4,830,000 of total unrecognized compensation cost related to outstanding stock option awards that will be recognized over a weighted average period of 2.04 years. The total fair value of shares vested during the year ended December 31, 2017 was approximately $4,094,000 . The total estimated fair value of options granted during the years ended December 31, 2017 and 2016 was $2,186,000 and $3,410,000 , respectively. The total estimated intrinsic value of options exercised during the years ended December 31, 2017 and 2016 was approximately $26 and $65,000 , respectively. As of December 31, 2017, the Company was authorized to grant options to purchase up to an additional 1,037,718 shares under the 2010 Equity Incentive Plan. The Company’s 2010 Plan provides for annual increases in the number of shares available for issuance thereunder on the first day of each fiscal year equal to the lesser of: (1) 2,000,000 shares of common stock; (2) 4% of the shares of common stock outstanding at that time; and (3) such other amount as our board of directors may determine. On January 1, 2018, an additional 2,000,000 shares became available for future issuance under the 2010 Plan. These additional shares from the annual increase under the 2010 Plan are not included in the foregoing discussion. Restricted Stock Units During the year ended December 31, 2017, the Company granted 964,720 restricted stock units (RSUs) to its employees in lieu of a cash bonus program for 2017. As of December 31, 2017, 839,285 RSUs were outstanding. During the year ended December 31, 2017, the Company recorded compensation expense related these RSUs of approximately $883,000 . |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
COMMON STOCK WARRANTS | COMMON STOCK WARRANTS The Company has issued warrants to purchase common stock to various members of the board of directors, third parties for services, and lenders. Warrants were issued to purchase a total of 1,795,663 shares of common stock as of December 31, 2017 and 2016 . As of December 31, 2017, the exercise prices ranged from $1.09 to $11.00 per share. The warrants are exercisable for a period between 5 and 10 years from the issuance date. In connection with Limited entering into the 2014 Loan Agreement (Note 9), the Company entered into the 2014 Warrant to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share. Sixty percent of the warrants were exercisable at the closing in April 2014 and the remaining forty percent became exercisable upon the funding of the additional $25,000,000 to Limited in September 2014. The Company agreed to amend the 2014 Warrant in connection with the First Loan Amendment to increase the number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. Upon entering into the Second Loan Amendment, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 862,069 and decrease the exercise price to $2.03 per share. In connection with the July 2016 Waiver, the Company agreed to further amend the 2014 Warrant to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. In connection with Limited entering into the Fourth Loan Amendment, the Company agreed to issue the 2016 Warrant to purchase up to 458,716 shares of the Company’s common stock at an exercise price of $1.09 per share, which was equal to $500,000 divided by the lowest volume-weighted average sale price for a share of the Company’s common stock reported over any ten consecutive trading days during the period commencing on and including September 23, 2016 and ending on the earlier to occur of (i) December 30, 2016 (inclusive of such date), and (ii) the second trading day immediately preceding the date of closing of a merger event (as defined in the 2016 Warrant). |
Concentrations and Credit Risk
Concentrations and Credit Risk | 12 Months Ended |
Dec. 31, 2017 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS AND CREDIT RISK | CONCENTRATIONS AND CREDIT RISK For the years ended December 31, 2017 and 2016, there were three customers within the U.S. segment. Two of these customers, which are large pharmaceutical distributors, accounted for approximately 73% and 75% , respectively, of the Company ’ s total consolidated revenues. These two customers accounted for approximately 81% and 90% of the Company ’ s consolidated accounts receivable as of December 31, 2017 and 2016, respectively. For the year ended December 31, 2017 one of the Company ’ s third-party manufacturers of ILUVIEN comprised approximately 10.5% of the Company ’ s total purchases. For the year ended December 31, 2016, there were no vendors that comprised more than 10% of the Company ’ s total purchases. The Company relies on a single manufacturer for ILUVIEN, a single manufacturer for the ILUVIEN applicator and a single active pharmaceutical ingredient manufacturer for ILUVIEN’s active pharmaceutical ingredient. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES On December 22, 2017, the United States enacted major tax reform legislation, Public Law No. 115-97, commonly referred to as the Tax Cuts and Jobs Act (2017 Tax Act). The more significant attributes of the 2017 Tax Act impose a repatriation tax on accumulated earnings of foreign subsidiaries, implements a territorial tax system together with a current tax on certain foreign earnings and lowers the general corporate income tax rate to 21%. The Company remeasured certain net deferred and other tax liabilities based on the tax rates at which they are expected to reverse in the future. The estimated amount recorded related to the remeasurement of these balances was a net benefit of $0 . The net estimated impact of the 2017 Tax Act is $0 due to a full valuation allowance recorded against the U.S. deferred tax assets. The components of net loss before taxes are as follows: Years Ended December 31, 2017 2016 (In thousands) United States $ (1,890 ) $ (8,516 ) Foreign (19,948 ) (24,486 ) Loss before provision for income taxes $ (21,838 ) $ (33,002 ) In accordance with ASC 740, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against the net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. The provision for income taxes consists of the following components: Years Ended December 31, 2017 2016 (In thousands) Current expense (benefit): Federal $ — $ — State — — Foreign 255 385 Current income tax expense 255 385 Deferred expense (benefit): Federal 549 3,099 State 3,330 (858 ) Foreign (92 ) (213 ) 3,787 2,028 Valuation allowance (3,879 ) (2,241 ) Deferred income tax benefit (92 ) (213 ) Total income tax expense $ 163 $ 172 The following summarizes activity related to the Company ’ s valuation allowance: Years Ended December 31, 2017 2016 (In thousands) Valuation allowance at beginning of period $ (55,968 ) $ (53,727 ) Income tax provision (3,879 ) (2,241 ) U.S. Tax Reform 18,362 — Valuation allowance at end of period $ (41,485 ) $ (55,968 ) Worldwide net deferred tax assets and liabilities are as follows: December 31, 2017 2016 Deferred tax assets (In thousands) Depreciation and amortization $ 44 $ 12 Other deferred tax assets 707 1,164 NOL carry-forwards 33,980 38,183 Research and development costs 1,340 3,063 Equity compensation 3,686 4,660 Collaboration agreement receivable reserves 2,256 9,327 Valuation allowance (41,485 ) (55,968 ) Total deferred tax assets $ 528 $ 441 Deferred tax liabilities Other deferred tax liabilities — (5 ) Total deferred tax liabilities — (5 ) Net deferred tax assets and deferred tax liabilities $ 528 $ 436 A reconciliation from the federal statutory rate to the total provision for income taxes is as follows: Years Ended December 31, 2017 2016 Amount Percent Amount Percent Federal tax benefit at statutory rate $ (7,425 ) 34.0 % $ (11,219 ) 34.0 % State tax — net of federal benefit (3,783 ) 17.3 (10 ) — Permanent items and other 686 (3.1 ) (225 ) 0.7 Foreign rate differential 6,880 (31.5 ) 8,470 (26.1 ) U.S. tax reform 18,362 (84.1 ) — Deferred rate change (212 ) 1.0 825 (2.5 ) Other 138 (0.6 ) 90 (0.3 ) Change in valuation allowance (14,483 ) 66.3 2,241 (6.3 ) Total tax expense (benefit) $ 163 (0.7 )% $ 172 (0.5 )% The change in state taxes, net of federal benefit, is a result of the Company filing additional state income tax returns in 2017. This resulted in approximately $3.8 million of state NOLs being generated. The impact of the deferred rate change as a result of the 2017 Tax Act is $18.4 million . The U.S. corporate tax rate change and state NOLs are fully offset by a valuation allowance recorded against U.S. federal and state income taxes; therefore, the overall impact of these items is zero to income tax expense. A rollforward of the Company’s uncertain tax positions is as follows: Years Ended December 31, 2017 2016 (In thousands) Balance of uncertain tax positions at beginning of period $ 59 $ 46 Gross increases - tax positions in current period 4 16 Gross increases - tax positions in prior period — 13 Gross decreases - tax positions in prior period (11 ) (16 ) Settlements — — Lapse of statute of limitations — — Balance of uncertain tax positions at end of period $ 52 $ 59 Included in the balance of unrecognized tax benefits as of December 31, 2017 and 2016 are approximately $52,000 and $59,000 , respectively, of tax benefits related to research and development tax credits. In accordance with ASC 740-10, such attributes are reduced to the amount that is expected to be recognized in the future. The Company does not accrue interest or penalties, as there is no risk of additional tax liability due to significant NOLs available. The Company does not expect any decreases to the unrecognized tax benefits within the next twelve months due to any lapses in statute of limitations. Tax years from 2014 to 2017 remain subject to examination in California, Georgia, Kentucky, Tennessee, Texas and on the federal level, with the exception of the assessment of NOL carry-forwards available for utilization, which can be examined for all years since 2009. The statute of limitations on these years will close when the NOLs expire or when the statute closes on the years in which the NOLs are utilized. Significant management judgment is involved in determining the provision for income taxes, deferred tax assets and liabilities, and any valuation allowance recorded against net deferred tax assets. Due to uncertainties with respect to the realization of deferred tax assets due to the history of operating losses, a valuation allowance has been established against the entire net deferred tax asset balance. The valuation allowance is based on management’s estimates of taxable income in the jurisdictions in which the Company operates and the period over which deferred tax assets will be recoverable. In the event that actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact the Company’s financial position and results of operations. As of December 31, 2017 and 2016 , the Company had federal net operating loss (NOL) carry-forwards of approximately $121,413,000 and $104,944,000 and state NOL carry-forwards of approximately $161,753,000 , and $83,270,000 respectively, subject to further limitation based upon the final results of our Internal Revenue Code (IRC) sections 382 and 383 analyses. These NOLs are available to reduce future income unless otherwise taxable. If not utilized, the federal NOL carry-forwards will expire at various dates between 2029 and 2037 and the state NOL carry-forwards will expire at various dates between 2020 and 2037. Sections 382 and 383 of the Internal Revenue Code limit the annual use of NOL carry-forwards and tax credit carry-forwards, respectively, following an ownership change. NOL carry-forwards may be subject to annual limitations under IRC Section 382 (Section 382) (or comparable provisions of state law) in the event that certain changes in ownership were to occur. The Company periodically evaluates its NOL carry-forwards and whether certain changes in ownership have occurred that would limit the Company’s ability to utilize a portion of its NOL carry-forwards. If it is determined that significant ownership changes have occurred since the Company generated its NOL carry-forwards, it may be subject to annual limitations on the use of these NOL carry-forwards under Section 382 (or comparable provisions of state law). The Company has determined that a Section 382 change in ownership occurred in late 2015. As a result of this change in ownership, the Company estimated that approximately $18.6 million of the Company ’ s federal NOLs and approximately $382,000 of federal tax credits generated prior to the change in ownership will not be utilized in the future. The Company is currently in the process of refining and finalizing these calculations, and upon finalization, will determine if a write-off is necessary. The reduction to the Company’s NOL deferred tax asset due to the annual Section 382 limitation and the NOL carryforward period would result in an offsetting reduction in valuation allowance recorded against the NOL deferred tax asset. As of December 31, 2017, the Company had cumulative book losses in foreign subsidiaries of approximately $113,278,000 . 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 does not expect to record deferred tax liabilities in the future related to excesses of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25. The 2017 Tax Act transitions the U.S. from a worldwide tax system to a territorial tax system. Under previous law, companies could indefinitely defer U.S. income taxation on unremitted foreign earnings. The 2017 Tax Act imposes a one-time transition tax on deferred foreign earnings of 15.5% for liquid assets and 8% for illiquid assets, payable in defined increments over eight years. Due to the cumulative book losses discussed above, this provision of the new law will have no impact on the Company. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE | FAIR VALUE The Company applies ASC 820, Fair Value Measurements in determining the fair value of certain assets and liabilities. Under this standard, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. In determining fair value, the Company uses various valuation approaches. The hierarchy of those valuation approaches is broken down into three levels based on the reliability of inputs as follows: Level 1 Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access Level 2 Valuations for which all significant inputs are observable, either directly or indirectly, other than level 1 inputs Level 3 Valuations based on inputs that are unobservable and significant to the overall fair value measurement There have been no changes in the methodologies used as of December 31, 2017 and 2016. The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2016 Level 1 Level 2 Level 3 Total (In thousands) Liabilities: Derivative warrant liability (2) $ — $ 188 $ — $ 188 Liabilities measured at fair value $ — $ 188 $ — $ 188 (1) The carrying amounts approximate fair value due to the short-term maturities of the cash equivalents. (2) The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Assumptions used are generally consistent with those disclosed for stock-based compensation (see Note 12). |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2017 | |
Retirement Benefits [Abstract] | |
EMPLOYEE BENEFIT PLANS | EMPLOYEE BENEFIT PLANS The Company has a salary deferral 401(k) plan that covers substantially all U.S. employees of the Company. The Company matches participant contributions subject to certain plan limitations. Compensation expense associated with the Company’s matching plan totaled $187,000 and $287,000 for the years ended December 31, 2017 and 2016 , respectively. The Company may also make an annual discretionary profit-sharing contribution. No such discretionary contributions were made during the years ended December 31, 2017 and 2016 , respectively. In April 2010, the Company established an Employee Stock Purchase Plan (the Purchase Plan). Under the Company’s Purchase Plan, eligible employees can participate and purchase common stock semi-annually through accumulated payroll deductions. The Purchase Plan is administered by the Company’s board of directors or a committee appointed by the Company’s board of directors. Under the Purchase Plan eligible employees may purchase stock at 85% of the lower of the fair market value of a share of common stock on the offering date or the exercise date. The Purchase Plan provides for two six -month purchase periods generally starting on the first trading day on or after October 31 and April 30 of each year. Eligible employees may contribute up to 15% of their eligible compensation. A participant may purchase a maximum of 2,500 shares of common stock per purchase period. The value of the shares purchased in any calendar year may not exceed $25,000 . The Purchase Plan was effective upon the completion of the Company’s IPO, at which time a total of 494,422 shares of the Company’s common stock were made available for sale. As of January 1 of each year, the number of available shares is automatically restored to the original level. A total of 79,733 and 82,760 shares of the Company’s common shares were acquired through the Purchase Plan during the years ended December 31, 2017 and 2016 , respectively. As such, on January 1, 2018 and 2017, respectively, an additional 79,733 and 82,760 shares became available for future issuance under the Purchase Plan. In accordance with ASC 718-50, the ability to purchase stock at 85% of the lower of the fair market value of a share of Common Stock on the offering date or the exercise date represents an option. The Company estimates the fair value of such options at the inception of each offering period using the Black-Scholes valuation model. In connection with the Purchase Plan, the Company recorded $38,000 and $80,000 of compensation expense for the years ended December 31, 2017 and 2016 , respectively. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2017 | |
Segment Reporting [Abstract] | |
Segment Information | SEGMENT INFORMATION For the years ended December 31, 2017 and 2016, there were three customers within the U.S. segment. Two of these customers, which are large pharmaceutical distributors, accounted for 73% and 75% of the Company’s consolidated revenues for the years ended December 31, 2017 and 2016, respectively. These same two customers within the U.S. segment accounted for approximately 81% and 90% of the Company’s consolidated accounts receivable at December 31, 2017 and 2016, respectively. 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 and regulatory environment. Each segment is separately managed and is evaluated primarily upon segment income or loss from operations. Non-cash items including stock-based compensation expense and depreciation and amortization are categorized as Other within the tables below. The following table presents a summary of the Company ’ s reporting segments for the years ended December 31, 2017 and 2016: Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 26,146 $ 9,766 $ — $ 35,912 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (2,482 ) (956 ) — (3,438 ) GROSS PROFIT 23,664 8,810 — 32,474 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 5,780 3,314 3,750 12,844 GENERAL AND ADMINISTRATIVE EXPENSES 7,580 2,605 2,854 13,039 SALES AND MARKETING EXPENSES 16,588 5,394 1,228 23,210 DEPRECIATION AND AMORTIZATION — — 2,684 2,684 RECOVERABLE COLLABORATION COSTS — — (2,851 ) (2,851 ) OPERATING EXPENSES 29,948 11,313 7,665 48,926 SEGMENT LOSS FROM OPERATIONS (6,284 ) (2,503 ) (7,665 ) (16,452 ) OTHER INCOME AND EXPENSES, NET (5,386 ) NET LOSS BEFORE TAXES $ (21,838 ) Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 25,765 $ 8,568 $ — $ 34,333 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,694 ) (650 ) — (2,344 ) GROSS PROFIT 24,071 7,918 — 31,989 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 7,183 4,289 903 12,375 GENERAL AND ADMINISTRATIVE EXPENSES 8,918 3,517 2,828 15,263 SALES AND MARKETING EXPENSES 21,252 7,021 1,158 29,431 DEPRECIATION AND AMORTIZATION — — 2,767 2,767 OPERATING EXPENSES 37,353 14,827 7,656 59,836 SEGMENT LOSS FROM OPERATIONS (13,282 ) (6,909 ) (7,656 ) (27,847 ) OTHER INCOME AND EXPENSES, NET (5,155 ) NET LOSS BEFORE TAXES $ (33,002 ) |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Selected quarterly financial data for years ended December 31, 2017 and 2016 are as follows (in thousands except per share data): March 31 June 30 September 30 December 31 (In thousands, except share and per share data) 2017 NET REVENUE $ 6,618 $ 10,368 $ 9,784 $ 9,142 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (587 ) (769 ) (1,039 ) (1,043 ) GROSS PROFIT 6,031 9,599 8,745 8,099 LOSS FROM OPERATIONS (5,511 ) (1,378 ) (3,825 ) (5,738 ) NET LOSS BEFORE TAXES (6,709 ) (2,713 ) (5,262 ) (7,154 ) NET LOSS (6,735 ) (2,757 ) (5,285 ) (7,224 ) NET LOSS PER SHARE — Basic and diluted (0.10 ) (0.04 ) (0.08 ) (0.10 ) 2016 NET REVENUE $ 5,801 $ 9,557 $ 8,298 $ 10,677 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (378 ) (556 ) (486 ) (924 ) GROSS PROFIT 5,423 9,001 7,812 9,753 LOSS FROM OPERATIONS (8,790 ) (6,449 ) (7,243 ) (5,365 ) NET LOSS BEFORE TAXES (11,136 ) (6,816 ) (9,212 ) (5,838 ) NET LOSS (11,145 ) (6,858 ) (9,245 ) (5,926 ) NET LOSS PER SHARE — Basic and diluted (0.25 ) (0.15 ) (0.16 ) (0.09 ) As a result of the Company’s weighted averages shares outstanding changing from quarter to quarter, the quarterly per share data will not necessarily add to the annual total. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | SUBSEQUENT EVENT As discussed in Note 9, on January 5, 2018, the Company entered into the 2018 Loan Agreement with Solar Capital. Under the 2018 Loan Agreement, the Company borrowed $40,000,000 as a term loan that matures on July 1, 2022. |
Summary of Significant Accoun28
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Use of Estimates in Financial Statements | Use of Estimates in Financial Statements — The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates. |
Principles of Consolidation | Principles of Consolidation — The consolidated financial statements include the accounts of Alimera Sciences, Inc. and all wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation. |
Cash and Cash Equivalents | Cash, Cash Equivalents and Restricted Cash — Cash equivalents include highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash and cash equivalents held at financial institutions are in excess of federally insured limits. Cash and cash equivalents were $24,067,000 and $30,979,000 as of December 31, 2017 and 2016, respectively, with approximately 93.0% and 92.0% of these balances, respectively held in U.S. based financial institutions. In addition, under its loan and security agreement with Hercules Capital, Inc. (Hercules), the Company was required to maintain minimum balances in specific bank accounts as collateral which are recorded as restricted cash (see Note 9). |
Revenue Recognition | Revenue — The Company recognizes revenue from its product sales when persuasive evidence of an arrangement exists, title to product and associated risk of loss have passed to the customer, the price is fixed or determinable, and collection from the customer is reasonably assured. Title passes generally upon receipt by the customer. Precise information regarding the receipt of product by the customer is not always readily available. In these cases, the Company estimates the date of receipt based upon shipping policies by geographic location. The Company ’ s shipping policies require delivery within 24 hours of shipment in most instances. Taxes that are collected from customers and remitted to governmental authorities, primarily in Europe, are not included in revenue. In the U.S., the Company sells ILUVIEN to a limited number of pharmaceutical distributors who in turn sell the product downstream to pharmacies and physician practices. Revenue is recorded net of provisions for estimated rebates, wholesaler chargebacks, distribution related fees, and other deductions. Calculating these provisions involves management’s estimates and judgments. The Company reviews its estimates of rebates, chargebacks and other applicable provisions each period and records any necessary adjustments in the current period’s net product sales. In the international segment, the Company sells ILUVIEN to hospitals, pharmacies and physician practices. Revenue is recorded net of provisions for contractual rebates, cash discounts, and other deductions. Additionally, in the international segment, the Company recognizes royalties from corporate partners based on third-party sales of ILUVIEN, and these royalties are recorded in accordance with contract terms when third-party results are reliably measurable and collectability is reasonably assured. Corporate partner revenues are composed mainly of royalties, license fees, and milestones earned. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts — Accounts receivable are generated through sales primarily to pharmacies, hospitals and wholesalers. The Company does not require collateral from its customers for accounts receivable. The carrying amount of accounts receivable is reduced by an allowance for doubtful accounts that reflects management ’ s best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. Provisions for doubtful accounts are charged to operations at the time management determines these accounts may become uncollectable. The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. As of December 31, 2017 and 2016, the Company had no reserve for doubtful accounts. |
Inventory | Inventory — Inventories are stated at the lower of cost or market with cost determined under the first in, first out (FIFO) method. Included in inventory costs are component parts, work-in-progress and finished goods. The Company relies on third party manufacturers for the production of all inventory and does not capitalize any internal costs. The Company periodically reviews inventories for excess, obsolete or expiring inventory and writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value. |
Intangible Assets | Intangible Assets — The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The Company estimated the useful life of its intangible asset at approximately thirteen years (see Note 6). |
Property and Equipment | Property and Equipment — Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture, fixtures and manufacturing equipment, five years ; automobiles, four years ; software and information technology hardware, three years ; and office equipment and leasehold improvements are amortized over the shorter of their estimated useful lives or the related lease life. |
Impairment | Impairment — Property and equipment and definite lived intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved. |
Income Taxes | Income Taxes — The Company provides for income taxes based on pretax income and applicable tax rates available in the various jurisdictions in which it operates. Significant judgment is required in determining the provision for income taxes and income tax assets and liabilities, including evaluating uncertainties in the application of accounting principles and complex tax laws. Deferred income taxes are recorded for the expected tax consequences of temporary differences between the bases of assets and liabilities, as well as for loss and tax credit carryforwards for financial reporting purposes and amounts recognized for income tax purposes. A valuation allowance is recorded to reduce the Company’s deferred tax assets to the amount of future tax benefit that is more likely than not to be realized. The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the consolidated financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized. The amount of unrecognized tax benefits (UTBs) is adjusted as appropriate for changes in facts and circumstances, such as significant amendments to existing tax law, new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, or resolution of an examination. The Company recognizes both accrued interest and penalties, where appropriate, related to UTBs in income tax expense. |
Research and Development Costs | Research and Development Costs — Research and development costs are expensed as incurred. Research and development expenses were $4,216,000 and $2,146,000 for the years ended December 31, 2017 and 2016, respectively. During the year ended December 31, 2017, the Company expensed $2,851,000 of in-process Research and Development Expense in connection with the New Collaboration Agreement (see Note 8). |
Stock-Based Compensation | Stock-Based Compensation — The Company has stock-based compensation plans under which various types of equity-based awards are granted, including restricted stock units (RSUs) and stock options. The fair values of RSUs and stock option awards, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over a service period, net of estimated forfeitures. Compensation expense is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 718, Compensation — Stock Compensation . The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model. Additionally, the Company sponsors an employee stock purchase plan (ESPP) under which employees may elect payroll withholdings to fund purchases of the Company’s stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company’s common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans . |
Derivative Financial Instruments | Derivative Financial Instruments — The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks. However, certain warrants to purchase Series A Convertible Preferred Stock or common stock that do not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the ASC, were classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants were considered derivative instruments at issuance because the agreements provide for settlement in Series A Convertible Preferred Shares or common shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future and contain anti-dilution provisions whereby the number of shares for which the warrants are exercisable and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. The warrant exercise price no longer can be adjusted at some point in the future. The primary underlying risk exposure pertaining to the warrants is the change in fair value of the underlying common stock. Such financial instruments are initially recorded at fair value with subsequent changes in fair value recorded as a component of change in fair value of derivative warrant liability in the consolidated statements of operations in each reporting period. If these instruments subsequently meet the requirements for equity classification, the Company reclassifies the fair value to equity. As of December 31, 2016, these warrants represented the only outstanding derivative instruments issued or held by the Company. The rights to exercise these warrants expired on October 1, 2017. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments — The carrying amounts of the Company’s financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company’s notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. |
Translation Policy | Foreign Currency Translation — The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using applicable exchange rates. The U.S. dollar effects that arise from translating net assets of these subsidiaries at changing rates are recognized in Accumulated other comprehensive loss . The earnings of these subsidiaries are translated into U.S. dollars using average exchange rates. |
Earnings Per Share (EPS) | Earnings Per Share (EPS) — Basic EPS is calculated in accordance with ASC 260, Earnings per Share by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average common shares outstanding for the dilutive effect of common stock options, warrants, convertible preferred stock and accrued but unpaid convertible preferred stock dividends. 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 to do so would have been anti-dilutive, were as follows: Years Ended December 31, 2017 2016 Series A convertible preferred stock 9,022,556 9,022,556 Series B convertible preferred stock 8,416,251 8,416,251 Series A convertible preferred stock warrants — 4,511,279 Common stock warrants 1,795,663 1,795,663 Stock options 11,595,510 10,804,412 Restricted stock units 839,285 — Total 31,669,265 34,550,161 |
Reporting Segments | Reporting Segments — The Company determines segments in accordance with its internal operating structure. 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 and regulatory environment. Each segment is separately managed and is evaluated primarily on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. The Company does not report balance sheet information by segment since it is not reviewed by the Company’s chief operating decision maker. The Company has three reportable segments, U.S., International and Other. Modification of Segment Footnote — The Company modified its segment footnote for the year ended December 31, 2016 for an immaterial change and removed, within the segment footnote, certain non-cash expenses including $4,889,000 of stock-based compensation expense and $2,767,000 of depreciation and amortization from the Company’s U.S. and International segments. These amounts are appropriately classified as Other within the segment footnote of these consolidated financial statements. Additionally, in the Company’s Annual Report on Form 10-K filing for the year ended December 31, 2016, the Company disclosed that the Company’s chief operating decision maker separately managed and evaluated each segment primarily upon net loss from operations. The modification made in these consolidated financial statements clarifies that the chief operating decision maker manages and evaluates each segment based on net loss from operations adjusted for certain non-cash items, such as stock-based compensation expense and depreciation and amortization. |
Adoption of New Accounting Pronouncements | Adoption of New Accounting Standards — In August 2014, the FASB issued ASU 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern . ASU 2014-15 requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date the financial statements are issued and provides guidance on determining when and how to disclose going concern uncertainties in the financial statements. ASU 2014-15 applies to all entities and is effective for annual and interim reporting periods ending after December 15, 2016, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements. In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory . This update requires entities to measure inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. This ASU is effective for annual reporting periods beginning after December 15, 2016 and interim periods within those years. The adoption of this guidance did not have a material impact on the Company’s financial statements. In August 2016, the FASB issued ASU 2016-15, Classification of Certain Cash Receipts and Cash Payments (Topic 230) . ASU 2016-15 is intended to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows and to eliminate the diversity in practice related to such classifications. The standard is effective for annual reporting periods beginning after December 15, 2017, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230) - Restricted Cash . ASU 2016-18 requires a statement of cash flows to explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective — In May 2014, the Financial Accounting Standards Board (FASB) issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) that amends the guidance for the recognition of revenue from contracts with customers to transfer goods and services. The FASB has subsequently issued additional, clarifying standards to address issues arising from implementation of the new revenue recognition standard. The new revenue recognition standard and clarifying standards are effective for interim and annual periods beginning on January 1, 2018. The new standards are required to be adopted using either a full-retrospective or a modified-retrospective approach. We will adopt these standards using the modified-retrospective approach beginning in 2018. We have completed our impact assessment and do not anticipate a material impact to net revenue in our Consolidated Statements of Operations, accounting policies, business processes, internal controls or disclosures. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . This standard requires all leases with durations greater than twelve months to be recognized on the balance sheet and is effective for interim and annual reporting periods beginning after December 15, 2018, although early adoption is permitted. The primary effect of adoption will be the requirement to record right-of-use assets and corresponding lease obligations for current operating leases. In addition, the standard will require that we update our systems, processes and controls we use to track, record and account for our lease portfolio. The Company is currently in the process of evaluating the impact of the adoption on the Company’s financial statements. |
Summary of Significant Accoun29
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because to do so would have been anti-dilutive, were as follows: Years Ended December 31, 2017 2016 Series A convertible preferred stock 9,022,556 9,022,556 Series B convertible preferred stock 8,416,251 8,416,251 Series A convertible preferred stock warrants — 4,511,279 Common stock warrants 1,795,663 1,795,663 Stock options 11,595,510 10,804,412 Restricted stock units 839,285 — Total 31,669,265 34,550,161 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: December 31, 2017 2016 (In thousands) Component parts (1) $ 404 $ 115 Work-in-process (2) 587 18 Finished goods 517 313 Total inventory 1,508 446 (1) Component parts inventory consisted of manufactured components of the ILUVIEN applicator. (2) Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: December 31, 2017 2016 (In thousands) Furniture and fixtures $ 392 $ 391 Office equipment 864 838 Automobiles 663 762 Software 1,122 973 Leasehold improvements 482 460 Manufacturing equipment 1,088 997 Total property and equipment 4,611 4,421 Less accumulated depreciation and amortization (3,201 ) (2,634 ) Property and equipment — net $ 1,410 $ 1,787 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets Future Amortization Expense | The estimated remaining amortization as of December 31, 2017 is as follows (in thousands): Years Ending December 31 2018 $ 1,940 2019 1,940 2020 1,946 2021 1,940 2022 1,940 Thereafter 8,958 Total $ 18,664 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2017 2016 (In thousands) Accrued clinical investigator expenses $ 696 $ 1,122 Accrued compensation expenses 511 1,020 Accrued rebate, chargeback and other revenue reserves 305 809 Accrued End of Term Payment (see Note 9) 1,400 — Other accrued expenses 670 807 Total accrued expenses $ 3,582 $ 3,758 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Principal Payments Under Note Payable | Under the Hercules Term Loan Agreement (see Note 9), as of December 31, 2017 , the Company was obligated to make future minimum principal payments, excluding (a) PIK Interest and (b) the $1,400,000 End of Term Payment that was scheduled to be paid in May 2018, as follows (in thousands): Years Ending December 31 (In thousands) 2018 $ 1,300 2019 $ 16,526 2020 $ 17,174 Total $ 35,000 |
Schedule of Future Minimum Rental Payments for Operating Leases | As of December 31, 2017 , a schedule by year of future minimum payments under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2018 $ 561 2019 533 2020 417 2021 301 Total $ 1,812 |
Schedule by Year of Future Minimum Payments under Capital Leases, Together with Present Value of Minimum Lease Payments | As of December 31, 2017 , a schedule by year of future minimum payments under capital leases, together with the present value of minimum lease payments, is as follows (in thousands): Years Ending December 31 (In thousands) 2018 262 2019 172 2020 95 Total 529 Less amount representing interest (30 ) Less amount representing executory costs (112 ) Present value of minimum lease payments 387 Less current portion (184 ) Non-current portion $ 203 |
Schedule of Property and Equipment Under Capital Leases | Property and equipment under capital leases, which are included in property and equipment (Note 5), consisted of the following: December 31, 2017 2016 (In thousands) Automobiles $ 663 $ 762 Office equipment 63 63 Less accumulated depreciation (311 ) (342 ) Total $ 415 $ 483 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Stock Option Transactions | A summary of stock option transactions under the plans are as follows: Years Ended December 31, 2017 2016 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 10,804,412 $ 3.22 9,475,890 $ 3.43 Grants 2,336,300 1.25 2,195,250 2.05 Forfeitures (1,544,473 ) 2.63 (581,497 ) 3.15 Exercises (729 ) 1.49 (285,231 ) 1.41 Options outstanding at year end 11,595,510 2.90 10,804,412 3.22 Options exercisable at year end 8,085,064 3.25 7,363,400 3.29 Weighted average per share fair value of options granted during the year $ 0.94 $ 1.55 |
Summary of Additional Stock Option Transactions | The following table provides additional information related to outstanding stock options, fully vested stock options, and stock options expected to vest as of December 31, 2017 : Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 11,595,510 $ 2.90 6.60 years $ — Exercisable 8,085,064 3.25 5.68 years — Outstanding, vested and expected to vest 11,161,477 2.94 6.51 years — |
Weighted-Average Assumptions Used for Option Grants | The weighted-average assumptions used for option grants were as follows: Years Ended December 31, 2017 2016 Risk-free interest rate 2.06 % 1.57 % Volatility factor 90.49 % 93.54 % Grant date fair value of common stock options $ 0.94 $ 1.55 Weighted-average expected life 6.02 years 5.99 years Assumed forfeiture rate 10.00 % 10.00 % |
Employee Stock-Based Compensation Expense | Employee stock-based compensation expense related to stock options recognized in accordance with ASC 718 was as follows: Years Ended December 31, 2017 2016 (In thousands) Sales and marketing $ 907 $ 1,109 Research, development and medical affairs 643 886 General and administrative 2,510 2,814 Total employee stock-based compensation expense $ 4,060 $ 4,809 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Components of Net Loss before Taxes | The components of net loss before taxes are as follows: Years Ended December 31, 2017 2016 (In thousands) United States $ (1,890 ) $ (8,516 ) Foreign (19,948 ) (24,486 ) Loss before provision for income taxes $ (21,838 ) $ (33,002 ) |
Components of Income Tax Benefit | The provision for income taxes consists of the following components: Years Ended December 31, 2017 2016 (In thousands) Current expense (benefit): Federal $ — $ — State — — Foreign 255 385 Current income tax expense 255 385 Deferred expense (benefit): Federal 549 3,099 State 3,330 (858 ) Foreign (92 ) (213 ) 3,787 2,028 Valuation allowance (3,879 ) (2,241 ) Deferred income tax benefit (92 ) (213 ) Total income tax expense $ 163 $ 172 |
Summary of Valuation Allowance | The following summarizes activity related to the Company ’ s valuation allowance: Years Ended December 31, 2017 2016 (In thousands) Valuation allowance at beginning of period $ (55,968 ) $ (53,727 ) Income tax provision (3,879 ) (2,241 ) U.S. Tax Reform 18,362 — Valuation allowance at end of period $ (41,485 ) $ (55,968 ) |
Net Deferred Tax Assets (Liabilities) | Worldwide net deferred tax assets and liabilities are as follows: December 31, 2017 2016 Deferred tax assets (In thousands) Depreciation and amortization $ 44 $ 12 Other deferred tax assets 707 1,164 NOL carry-forwards 33,980 38,183 Research and development costs 1,340 3,063 Equity compensation 3,686 4,660 Collaboration agreement receivable reserves 2,256 9,327 Valuation allowance (41,485 ) (55,968 ) Total deferred tax assets $ 528 $ 441 Deferred tax liabilities Other deferred tax liabilities — (5 ) Total deferred tax liabilities — (5 ) Net deferred tax assets and deferred tax liabilities $ 528 $ 436 |
Reconciliation of Income Tax Benefit to Amount Determined by Applying U.S. Federal Statutory Income Tax Rate | A reconciliation from the federal statutory rate to the total provision for income taxes is as follows: Years Ended December 31, 2017 2016 Amount Percent Amount Percent Federal tax benefit at statutory rate $ (7,425 ) 34.0 % $ (11,219 ) 34.0 % State tax — net of federal benefit (3,783 ) 17.3 (10 ) — Permanent items and other 686 (3.1 ) (225 ) 0.7 Foreign rate differential 6,880 (31.5 ) 8,470 (26.1 ) U.S. tax reform 18,362 (84.1 ) — Deferred rate change (212 ) 1.0 825 (2.5 ) Other 138 (0.6 ) 90 (0.3 ) Change in valuation allowance (14,483 ) 66.3 2,241 (6.3 ) Total tax expense (benefit) $ 163 (0.7 )% $ 172 (0.5 )% |
Uncertain Tax Positions Rollforward | A rollforward of the Company’s uncertain tax positions is as follows: Years Ended December 31, 2017 2016 (In thousands) Balance of uncertain tax positions at beginning of period $ 59 $ 46 Gross increases - tax positions in current period 4 16 Gross increases - tax positions in prior period — 13 Gross decreases - tax positions in prior period (11 ) (16 ) Settlements — — Lapse of statute of limitations — — Balance of uncertain tax positions at end of period $ 52 $ 59 |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Assets Measured at Fair Value on Recurring Basis | The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2016 Level 1 Level 2 Level 3 Total (In thousands) Liabilities: Derivative warrant liability (2) $ — $ 188 $ — $ 188 Liabilities measured at fair value $ — $ 188 $ — $ 188 (1) The carrying amounts approximate fair value due to the short-term maturities of the cash equivalents. (2) The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Assumptions used are generally consistent with those disclosed for stock-based compensation (see Note 12). |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Segment Reporting [Abstract] | |
Schedule of Reporting Segments | The following table presents a summary of the Company ’ s reporting segments for the years ended December 31, 2017 and 2016: Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 26,146 $ 9,766 $ — $ 35,912 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (2,482 ) (956 ) — (3,438 ) GROSS PROFIT 23,664 8,810 — 32,474 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 5,780 3,314 3,750 12,844 GENERAL AND ADMINISTRATIVE EXPENSES 7,580 2,605 2,854 13,039 SALES AND MARKETING EXPENSES 16,588 5,394 1,228 23,210 DEPRECIATION AND AMORTIZATION — — 2,684 2,684 RECOVERABLE COLLABORATION COSTS — — (2,851 ) (2,851 ) OPERATING EXPENSES 29,948 11,313 7,665 48,926 SEGMENT LOSS FROM OPERATIONS (6,284 ) (2,503 ) (7,665 ) (16,452 ) OTHER INCOME AND EXPENSES, NET (5,386 ) NET LOSS BEFORE TAXES $ (21,838 ) Year Ended U.S. International Other Consolidated (In thousands) NET REVENUE $ 25,765 $ 8,568 $ — $ 34,333 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1,694 ) (650 ) — (2,344 ) GROSS PROFIT 24,071 7,918 — 31,989 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 7,183 4,289 903 12,375 GENERAL AND ADMINISTRATIVE EXPENSES 8,918 3,517 2,828 15,263 SALES AND MARKETING EXPENSES 21,252 7,021 1,158 29,431 DEPRECIATION AND AMORTIZATION — — 2,767 2,767 OPERATING EXPENSES 37,353 14,827 7,656 59,836 SEGMENT LOSS FROM OPERATIONS (13,282 ) (6,909 ) (7,656 ) (27,847 ) OTHER INCOME AND EXPENSES, NET (5,155 ) NET LOSS BEFORE TAXES $ (33,002 ) |
Selected Quarterly Financial 39
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | Selected quarterly financial data for years ended December 31, 2017 and 2016 are as follows (in thousands except per share data): March 31 June 30 September 30 December 31 (In thousands, except share and per share data) 2017 NET REVENUE $ 6,618 $ 10,368 $ 9,784 $ 9,142 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (587 ) (769 ) (1,039 ) (1,043 ) GROSS PROFIT 6,031 9,599 8,745 8,099 LOSS FROM OPERATIONS (5,511 ) (1,378 ) (3,825 ) (5,738 ) NET LOSS BEFORE TAXES (6,709 ) (2,713 ) (5,262 ) (7,154 ) NET LOSS (6,735 ) (2,757 ) (5,285 ) (7,224 ) NET LOSS PER SHARE — Basic and diluted (0.10 ) (0.04 ) (0.08 ) (0.10 ) 2016 NET REVENUE $ 5,801 $ 9,557 $ 8,298 $ 10,677 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (378 ) (556 ) (486 ) (924 ) GROSS PROFIT 5,423 9,001 7,812 9,753 LOSS FROM OPERATIONS (8,790 ) (6,449 ) (7,243 ) (5,365 ) NET LOSS BEFORE TAXES (11,136 ) (6,816 ) (9,212 ) (5,838 ) NET LOSS (11,145 ) (6,858 ) (9,245 ) (5,926 ) NET LOSS PER SHARE — Basic and diluted (0.25 ) (0.15 ) (0.16 ) (0.09 ) |
Nature of Operations (Detail)
Nature of Operations (Detail) - ILUVIEN | 1 Months Ended | 12 Months Ended |
Dec. 31, 2017country | Dec. 31, 2017Patient | |
Nature Of Operations [Line Items] | ||
Post-authorization open study period | 5 years | |
Maximum number of patients involved in post-authorization open study period | 800 | |
Number of patients involved in post-authorization open study period | 562 | |
Number of countries in which company plans to file application for new indication | country | 17 |
Summary of Significant Accoun41
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017USD ($)Segment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 24,067 | $ 30,979 | $ 31,075 |
Percentage of cash and cash equivalents in domestic financial institutions | 93.00% | 92.00% | |
Useful life of intangible assets | 13 years | ||
Research and development expense | $ 4,216 | $ 2,146 | |
In-process research and development expense | $ 2,851 | ||
Number of reportable segments | Segment | 3 |
Summary of Significant Accoun42
Summary of Significant Accounting Policies - Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2017 | |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Automobiles | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 4 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Summary of Significant Accoun43
Summary of Significant Accounting Policies - Securities Not Included in Computation of Diluted EPS (Detail) - shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 31,669,265 | 34,550,161 |
Series A convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 9,022,556 | 9,022,556 |
Series B convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 8,416,251 | 8,416,251 |
Series A convertible preferred stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 0 | 4,511,279 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 1,795,663 | 1,795,663 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 11,595,510 | 10,804,412 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total potentially dilutive securities (in shares) | 839,285 | 0 |
Summary of Significant Accoun44
Summary of Significant Accounting Policies - Modification of Segment Footnote (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Segment Reporting Information [Line Items] | ||
Stock compensation expense | $ 4,981 | $ 4,889 |
Depreciation and amortization expense | 2,684 | 2,767 |
Other Segments | ||
Segment Reporting Information [Line Items] | ||
Stock compensation expense | 4,889 | |
Depreciation and amortization expense | $ 2,684 | $ 2,767 |
Going Concern (Detail)
Going Concern (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Class of Stock [Line Items] | |||
Accumulated deficit | $ 399,075 | $ 377,074 | |
Cash and cash equivalents | 24,067 | 30,979 | $ 31,075 |
Proceeds from sale of common stock | 6,084 | $ 27,763 | |
Capital shares reserved for future issuance | 25,000 | ||
Private Placement | Common Stock | |||
Class of Stock [Line Items] | |||
Proceeds from sale of common stock | $ 6,001 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 | |
Inventory net realizable value | |||
Component parts | [1] | $ 404 | $ 115 |
Work-in-process | [2] | 587 | 18 |
Finished goods | 517 | 313 | |
Total inventory | $ 1,508 | $ 446 | |
[1] | Component parts inventory consisted of manufactured components of the ILUVIEN applicator. | ||
[2] | Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EEA regulatory authorities. |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 4,611 | $ 4,421 |
Less accumulated depreciation and amortization | (3,201) | (2,634) |
Property and equipment — net | 1,410 | 1,787 |
Depreciation expense | 744 | 822 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 392 | 391 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 864 | 838 |
Automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 663 | 762 |
Software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 1,122 | 973 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 482 | 460 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,088 | $ 997 |
Intangible Assets - Activity (D
Intangible Assets - Activity (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2014 | Dec. 31, 2017 | Dec. 31, 2016 | |
Finite-Lived Intangible Assets [Line Items] | |||
Useful life | 13 years | ||
Intangible assets, net | $ 18,664,000 | ||
Licensing Agreement | |||
Finite-Lived Intangible Assets [Line Items] | |||
Intangible assets, gross | $ 25,000,000 | ||
Useful life | 13 years | ||
Intangible assets, net | $ 18,664,000 | $ 20,604,000 | |
Intangible asset amortization expense | $ 1,940,000 | $ 1,946,000 | |
pSivida | |||
Finite-Lived Intangible Assets [Line Items] | |||
Additional milestone payment after the first product approved by the FDA | $ 25,000,000 |
Intangible Assets - Future Amor
Intangible Assets - Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2017USD ($) |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | |
2,018 | $ 1,940 |
2,019 | 1,940 |
2,020 | 1,946 |
2,021 | 1,940 |
2,022 | 1,940 |
Thereafter | 8,958 |
Total | $ 18,664 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Summary of accrued expenses | ||
Accrued clinical investigator expenses | $ 696 | $ 1,122 |
Accrued compensation expenses | 511 | 1,020 |
Accrued rebate, chargeback and other revenue reserves | 305 | 809 |
Accrued End of Term Payment (see Note 9) | 1,400 | 0 |
Other accrued expenses | 670 | 807 |
Total accrued expenses | $ 3,582 | $ 3,758 |
License Agreements (Details)
License Agreements (Details) - USD ($) | Jul. 10, 2017 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Jun. 30, 2017 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
In-process research and development expense | $ 2,851,000 | ||||
Collaboration costs recoveries | $ 2,851,000 | $ 0 | |||
pSivida | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Share of net profits | 20.00% | 20.00% | |||
Share of any lump sum milestone payments received from sub licensee | 33.00% | ||||
Recovery of commercialization costs | 20.00% | ||||
Commercialization costs owned | 24,475,000 | ||||
Collaborative agreement, capped future offset amount | $ 25,000,000 | $ 25,000,000 | |||
Collaborative arrangement, royalty payable on net revenue (as a percentage) | 2.00% | ||||
Collaborative arrangement, increase in royalty payable on net revenue (as a percentage) | 6.00% | ||||
Collaborative arrangement, royalty payable on net revenue over threshold (as a percentage) | 2.00% | ||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000,000 | ||||
Royalty expense | $ 621,000 | $ 254,000 | |||
Collaborative arrangement, forgiveness of future offset | $ 10,000,000 | ||||
Reduction in royalty on net revenues up to threshold, first two years (as a percentage) | 4.00% | ||||
Reduction in royalty on net revenues in excess of threshold, first two years (as a percentage) | 5.00% | ||||
Reduction in royalty on net revenues up to threshold, third year and thereafter (as a percentage) | 5.20% | ||||
Reduction in royalty on net revenues in excess of threshold, third year and thereafter (as a percentage) | 6.80% | ||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | ||||
In-process research and development expense | $ 2,851,000 | ||||
Collaboration costs recoveries | $ 2,851,000 | ||||
Minimum days to require to revert license in case of breaches of contract | 30 days | ||||
Maximum days to require to revert license in case of breaches of contract | 90 days | ||||
Period of bankruptcy petition proceedings remains undismissed | 60 days | ||||
pSivida | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Recoverable amount to offset future royalty payments | 15,000,000 | ||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | ||||
pSivida | Accounts Payable | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Royalty expense | $ 184,000 |
Loan Agreements Narrative (Deta
Loan Agreements Narrative (Details) | Jan. 05, 2018USD ($) | Oct. 31, 2016USD ($)payment$ / sharesshares | Aug. 31, 2016USD ($) | Nov. 30, 2015USD ($)$ / sharesshares | Apr. 30, 2014USD ($)$ / sharesshares | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jul. 31, 2016USD ($)$ / sharesshares | May 31, 2016USD ($) | Sep. 30, 2014USD ($) |
Debt Instrument [Line Items] | ||||||||||||||||||
Balloon payment to be paid | $ 1,400,000 | $ 0 | $ 1,400,000 | $ 0 | ||||||||||||||
Loss on early extinguishment of debt | 0 | 2,564,000 | ||||||||||||||||
Payments of debt issuance costs | 0 | 1,069,000 | ||||||||||||||||
Revenues | $ 9,142,000 | $ 9,784,000 | $ 10,368,000 | $ 6,618,000 | $ 10,677,000 | $ 8,298,000 | $ 9,557,000 | $ 5,801,000 | $ 35,912,000 | 34,333,000 | ||||||||
2018 Loan Agreement | Solar Capital Ltd. | Subsequent event | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Amount borrowed under loan agreement | $ 40,000,000 | |||||||||||||||||
Upfront fee payment to Lenders | $ 1,800,000 | |||||||||||||||||
Interest only payments, term (in months) | 30 months | |||||||||||||||||
Interest only payments, additional term | 6 months | |||||||||||||||||
Principal and interest payments, term (in months) | 18 months | |||||||||||||||||
Payments for closing fees | $ 400,000 | |||||||||||||||||
Fee amount if interest only period is extended | $ 2,000,000 | |||||||||||||||||
Interest only payments, extension term (in months) | 36 months | |||||||||||||||||
Incremental prepayments of outstanding balance | $ 10,000,000 | |||||||||||||||||
Debt instrument, additional exit fee | $ 1,000,000 | |||||||||||||||||
Percentage of voting interests | 65.00% | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | Subsequent event | Exit Fee Agreement | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Debt instrument, term (in years) | 10 years | |||||||||||||||||
Debt instrument, exit fee | $ 2,000,000 | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | Tranche One | Subsequent event | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Principal prepayment fee percentage, first 12 months | 2.00% | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | Tranche One | Subsequent event | ILUVIEN | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Revenues | $ 80,000,000 | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | Tranche Two | Subsequent event | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Principal prepayment fee percentage, greater than 12 months, less than 24 months | 1.00% | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | Tranche Two | Subsequent event | ILUVIEN | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Revenues | $ 100,000,000 | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | Tranche Three | Subsequent event | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Principal prepayment fee percentage, greater than 24 months | 0.50% | |||||||||||||||||
Number of days before maturity date | 30 days | |||||||||||||||||
2018 Loan Agreement | Solar Capital Ltd. | LIBOR | Subsequent event | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Basis spread on variable rate (percent) | 7.65% | |||||||||||||||||
Alimera Sciences Limited | 2014 Term Loan | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Amount borrowed under loan agreement | $ 35,000,000 | |||||||||||||||||
Term loan amount | $ 10,000,000 | $ 25,000,000 | ||||||||||||||||
Interest rate on term loan (percent) | 10.90% | |||||||||||||||||
Interest rate on Term Loan Agreement | 12.00% | 12.00% | ||||||||||||||||
Minimum liquidity threshold per covenant | $ 35,000,000 | |||||||||||||||||
Alimera Sciences Limited | 2014 Term Loan | Hercules Technology Growth Capital | Prime Rate | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Basis spread on variable rate (percent) | 7.65% | |||||||||||||||||
Alimera Sciences Limited | First Loan Amendment | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Upfront fee payment to Lenders | $ 263,000 | |||||||||||||||||
Balloon payment to be paid | $ 1,050,000 | |||||||||||||||||
Balloon payment, percent of principal | 3.00% | |||||||||||||||||
Alimera Sciences Limited | Second Loan Amendment | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Upfront fee payment to Lenders | 350,000 | |||||||||||||||||
Balloon payment to be paid | $ 1,400,000 | |||||||||||||||||
Loss on early extinguishment of debt | 2,564,000 | |||||||||||||||||
Payments of debt issuance costs | $ 360,000 | |||||||||||||||||
Alimera Sciences Limited | Third Loan Amendment | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Minimum required cash balance per covenant | $ 2,000,000 | |||||||||||||||||
Alimera Sciences Limited | July 2016 Waiver | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Upfront fee payment to Lenders | $ 350,000 | |||||||||||||||||
Weekly ticking fee (percent) | 0.05% | |||||||||||||||||
Ticking fee | $ 65,000 | |||||||||||||||||
Alimera Sciences Limited | Fourth Loan Amendment | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Interest rate on term loan (percent) | 11.00% | |||||||||||||||||
Upfront fee payment to Lenders | $ 338,000 | |||||||||||||||||
Increase in borrowing capacity | $ 10,000,000 | |||||||||||||||||
Payment-in-kind interest rate | 1.00% | |||||||||||||||||
Number of monthly payments | payment | 24 | |||||||||||||||||
Prepayment fee percentage within the first year of borrowing | 3.00% | |||||||||||||||||
Prepayment fee percentage within the second year of borrowing | 2.00% | |||||||||||||||||
Prepayment fee percentage after the second year of borrowing and thereafter | 1.00% | |||||||||||||||||
Minimum liquidity threshold per covenant | $ 35,000,000 | |||||||||||||||||
Number of shares called by warrants | shares | 458,716 | |||||||||||||||||
Exercise price on warrants (in dollars per share) | $ / shares | $ 1.09 | |||||||||||||||||
Amount used In calculation of exercise price | $ 500,000 | |||||||||||||||||
Alimera Sciences Limited | Fourth Loan Amendment | Hercules Technology Growth Capital | Tranche One | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Increase in borrowing capacity | 5,000,000 | |||||||||||||||||
Revenue requirement | 12,000,000 | |||||||||||||||||
Alimera Sciences Limited | Fourth Loan Amendment | Hercules Technology Growth Capital | Tranche Two | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Increase in borrowing capacity | 5,000,000 | |||||||||||||||||
Revenue requirement | $ 15,000,000 | |||||||||||||||||
Alimera Sciences Limited | Fourth Loan Amendment | Hercules Technology Growth Capital | Prime Rate | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Basis spread on variable rate (percent) | 11.00% | |||||||||||||||||
Reduction in basis spread on variable rate | 3.50% | |||||||||||||||||
Alimera Sciences, Inc. | 2014 Term Loan | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Term loan amount | $ 25,000,000 | |||||||||||||||||
Number of shares called by warrants | shares | 285,016 | |||||||||||||||||
Exercise price on warrants (in dollars per share) | $ / shares | $ 6.14 | |||||||||||||||||
Percent of warrants exercisable upon closing | 60.00% | |||||||||||||||||
Percent of warrants exercisable upon satisfying certain conditions | 40.00% | |||||||||||||||||
Alimera Sciences, Inc. | First Loan Amendment | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Number of shares called by warrants | shares | 660,377 | |||||||||||||||||
Exercise price on warrants (in dollars per share) | $ / shares | $ 2.65 | |||||||||||||||||
Alimera Sciences, Inc. | Second Loan Amendment | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Number of shares called by warrants | shares | 862,069 | |||||||||||||||||
Exercise price on warrants (in dollars per share) | $ / shares | $ 2.03 | |||||||||||||||||
Alimera Sciences, Inc. | July 2016 Waiver | Hercules Technology Growth Capital | ||||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||||
Number of shares called by warrants | shares | 1,258,993 | |||||||||||||||||
Exercise price on warrants (in dollars per share) | $ / shares | $ 1.39 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Jan. 01, 2018USD ($)Employee | May 31, 2013contract | Feb. 28, 2010 | Dec. 31, 2017USD ($)Employee | Dec. 31, 2016USD ($) | Dec. 31, 2016USD ($)agreement | Mar. 31, 2016USD ($) |
Commitments and Contingencies [Line Items] | |||||||
Balloon payment to be paid | $ 1,400 | $ 0 | $ 0 | ||||
Accrued and unpaid interest payable on Note Payable | 363 | 336 | 336 | ||||
Rent expense under all operating leases | 499 | 544 | |||||
Depreciation expense | $ 744 | 822 | |||||
Percentage of order of ILUVIEN units required | 80.00% | ||||||
Agreement period | 6 years | ||||||
Renewal option additional period | 1 year | ||||||
Prior written notice period | 12 months | ||||||
Contract extension terms | 5 years | ||||||
Number of executives in employment agreements | Employee | 5 | ||||||
CRO Agreement, physician utilization study | |||||||
Commitments and Contingencies [Line Items] | |||||||
Clinical and data management services expense | $ 101 | 157 | |||||
Outsourced services payable | 67 | 76 | $ 76 | ||||
Clinical and data management services expense expected to be incurred | $ 390 | ||||||
ILUVIEN | |||||||
Commitments and Contingencies [Line Items] | |||||||
Post-authorization open study period | 5 years | ||||||
ILUVIEN | CRO Agreement, physician utilization study | |||||||
Commitments and Contingencies [Line Items] | |||||||
Number of contract research organizations engaged | contract | 3 | ||||||
Post-authorization open study period | 5 years | ||||||
Number of agreements for clinical and data management services | agreement | 9 | ||||||
Capital leased assets | |||||||
Commitments and Contingencies [Line Items] | |||||||
Depreciation expense | $ 172 | $ 267 | |||||
Subsequent event | |||||||
Commitments and Contingencies [Line Items] | |||||||
Number of executives in employment agreements | Employee | 5 | ||||||
Subsequent event | Minimum | |||||||
Commitments and Contingencies [Line Items] | |||||||
Executives salaries | $ 338 | ||||||
Subsequent event | Maximum | |||||||
Commitments and Contingencies [Line Items] | |||||||
Executives salaries | $ 600 | ||||||
Second Loan Amendment | Alimera Sciences Limited | Hercules Technology Growth Capital | |||||||
Commitments and Contingencies [Line Items] | |||||||
Balloon payment to be paid | $ 1,400 |
Commitments and Contingencies54
Commitments and Contingencies - Schedule of Future Minimum Principal Payments Under Note Payable (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2,018 | $ 1,300 |
2,019 | 16,526 |
2,020 | 17,174 |
Total | $ 35,000 |
Commitments and Contingencies55
Commitments and Contingencies - Schedule of Operating Lease Assets (Details) $ in Thousands | Dec. 31, 2017USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2,018 | $ 561 |
2,019 | 533 |
2,020 | 417 |
2,021 | 301 |
Total | $ 1,812 |
Commitments and Contingencies56
Commitments and Contingencies - Schedule by Year of Future Minimum Payments under Capital Leases, Together with Present Value of Minimum Lease Payments (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Capital Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||
2,018 | $ 262 | |
2,019 | 172 | |
2,020 | 95 | |
Total | 529 | |
Less amount representing interest | (30) | |
Less amount representing executory costs | (112) | |
Present value of minimum lease payments | 387 | |
Less current portion | (184) | $ (191) |
Non-current portion | $ 203 | $ 274 |
Commitments and Contingencies57
Commitments and Contingencies - Property and Equipment Under Capital Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Capital Leased Assets [Line Items] | ||
Less accumulated depreciation | $ (311) | $ (342) |
Total | 415 | 483 |
Automobiles | ||
Capital Leased Assets [Line Items] | ||
Gross capital leased assets | 663 | 762 |
Office equipment | ||
Capital Leased Assets [Line Items] | ||
Gross capital leased assets | $ 63 | $ 63 |
Preferred Stock (Detail)
Preferred Stock (Detail) - USD ($) | Dec. 12, 2014 | Oct. 02, 2012 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 |
Class of Stock [Line Items] | |||||
Estimated fair value of derivatives | $ 188,000 | ||||
Gain (loss) on change in fair value of derivatives | $ 188,000 | 2,627,000 | |||
Stock issuance costs incurred | $ 183,000 | $ 1,341,000 | |||
Series A convertible preferred stock | |||||
Class of Stock [Line Items] | |||||
Number of preferred stock and warrants. | 1,000,000 | ||||
Warrants to purchase additional shares | 300,000 | ||||
Gross proceeds under securities purchase agreement | $ 40,000,000 | ||||
Estimated total stock issuance cost | $ 560,000 | ||||
Gross proceeds under securities purchase agreement per value | $ 40 | ||||
Initial conversion price subjected to adjustment two (in dollars per share) | 2.66 | ||||
Preferred stock converted to common stock per share (in dollars per share) | $ 10 | ||||
Proceeds from issuance of preferred stock | $ 30,000,000 | ||||
Proportion of each unit of shares (in shares) | 0.30 | ||||
Exercise price of warrants (in dollars per share) | $ 44 | ||||
Shares converted (in shares) | 400,000 | ||||
Preferred stock, shares issued (in shares) | 600,000 | 600,000 | |||
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 | |||
Common Stock | |||||
Class of Stock [Line Items] | |||||
Shares issued in conversion of preferred stock (in shares) | 6,015,037 | ||||
Series B convertible preferred stock | |||||
Class of Stock [Line Items] | |||||
Preferred stock, shares issued (in shares) | 8,416.251 | 8,416.251 | |||
Preferred stock, shares outstanding (in shares) | 8,416.251 | 8,416.251 | |||
Issuance of preferred stock (in shares) | 8,291.873 | ||||
Issuance of preferred stock (in dollars per share) | $ 6,030 | ||||
Issuance of preferred stock | $ 50,000,000 | ||||
Stock issuance costs incurred | $ 432,000 | ||||
Common stock issued upon conversion (per preferred share) | 1,000 | ||||
Ownership interest of holders after conversion of preferred stock (percent) | 9.98% | ||||
Intrinsic value of beneficial conversion feature | $ 750,000 | ||||
Series B convertible preferred stock | Over-Allotment Option | |||||
Class of Stock [Line Items] | |||||
Issuance of preferred stock (in shares) | 124.378 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Information (Detail) - USD ($) | Jan. 01, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2010 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Contractual term | 5 years 8 months 5 days | |||
Total estimated fair value of options granted | $ 2,186,000 | $ 3,410,000 | ||
Total estimated intrinsic value of options exercised | 26 | 65,000 | ||
Employee stock-based compensation expense | $ 4,060,000 | $ 4,809,000 | ||
Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Contractual term | 10 years | |||
Total unrecognized compensation cost related to outstanding stock option awards | $ 4,830,000 | |||
Total unrecognized compensation cost related to outstanding stock option awards, recognition period (in years) | 2 years 15 days | |||
Total fair value of shares vested during period | $ 4,094,000 | |||
Restricted stock units | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Equity instruments other than options, grants in period (RSU's) | 964,720 | |||
Equity instruments other than options, nonvested (RSU's) | 839,285 | |||
Employee stock-based compensation expense | $ 883,000 | |||
Directors Option Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 4 years | |||
Contractual term | 10 years | |||
2010 Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Maximum number of shares the company is authorized to grant | 1,037,718 | |||
Additional shares that became available for future issuance | 2,000,000 | |||
Percentage of outstanding common stock, maximum | 4.00% | |||
2010 Equity Incentive Plan | Subsequent event | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Additional shares that became available for future issuance | 2,000,000 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Stock Option Transactions (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Options | ||
Options outstanding at beginning of period (in shares) | 10,804,412 | 9,475,890 |
Grants (in shares) | 2,336,300 | 2,195,250 |
Forfeitures (in shares) | (1,544,473) | (581,497) |
Exercises (in shares) | (729) | (285,231) |
Options outstanding at year end (in shares) | 11,595,510 | 10,804,412 |
Options exercisable at year end (in shares) | 8,085,064 | 7,363,400 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 0.94 | $ 1.55 |
Weighted Average Exercise Price | ||
Options outstanding at beginning of period (in dollars per share) | 3.22 | 3.43 |
Grants (in dollars per share) | 1.25 | 2.05 |
Forfeitures (in dollars per share) | 2.63 | 3.15 |
Exercises (in dollars per share) | 1.49 | 1.41 |
Options outstanding at year end (in dollars per share) | 2.90 | 3.22 |
Options exercisable at year end (in dollars per share) | $ 3.25 | $ 3.29 |
Stock Incentive Plans - Addit61
Stock Incentive Plans - Additional Stock Option Transactions (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Outstanding, Shares | 11,595,510 | 10,804,412 | 9,475,890 |
Exercisable, Shares | 8,085,064 | 7,363,400 | |
Outstanding, vested and expected to vest, Shares | 11,161,477 | ||
Outstanding, weighted average exercise price (in dollars per share) | $ 2.90 | $ 3.22 | $ 3.43 |
Exercisable, weighted average exercise price (in dollars per share) | 3.25 | $ 3.29 | |
Outstanding, vested and expected to vest, Weighted Average Exercise Price (in dollars per share) | $ 2.94 | ||
Outstanding, weighted average contractual term | 6 years 7 months 5 days | ||
Exercisable, weighted average contractual term | 5 years 8 months 5 days | ||
Outstanding, vested and expected to vest, Weighted Average Contractual Term | 6 years 6 months 5 days | ||
Outstanding, aggregate intrinsic value | $ 0 | ||
Exercisable, aggregate intrinsic value | 0 | ||
Outstanding, vested and expected to vest, Aggregate Intrinsic Value | $ 0 |
Stock Incentive Plans - Weighte
Stock Incentive Plans - Weighted-Average Assumptions Used for Option Grants (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Risk-free interest rate (percent) | 2.06% | 1.57% |
Volatility factor (percent) | 90.49% | 93.54% |
Grant date fair value of common stock options (in dollars per share) | $ 0.94 | $ 1.55 |
Weighted-average expected life | 6 years 8 days | 5 years 11 months 27 days |
Assumed forfeiture rate (percent) | 10.00% | 10.00% |
Stock Incentive Plans - Employe
Stock Incentive Plans - Employee Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense | $ 4,060 | $ 4,809 |
Sales and marketing | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense | 907 | 1,109 |
Research, development and medical affairs | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense | 643 | 886 |
General and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Total employee stock-based compensation expense | $ 2,510 | $ 2,814 |
Common Stock Warrants (Detail)
Common Stock Warrants (Detail) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2017 | Oct. 31, 2016 | Jul. 31, 2016 | Nov. 30, 2015 | Sep. 30, 2014 | Apr. 30, 2014 | |
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase common stock issued and outstanding (in shares) | 1,795,663 | |||||
Minimum | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase common, exercise prices (in dollars per share) | $ 1.09 | |||||
Warrants, exercisable period from issuance date | 5 years | |||||
Maximum | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase common, exercise prices (in dollars per share) | $ 11 | |||||
Warrants, exercisable period from issuance date | 10 years | |||||
2014 Term Loan | Hercules | Alimera Sciences, Inc. | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase Company's common stock, granted during period (in shares) | 285,016 | |||||
Exercise price on warrants (in dollars per share) | $ 6.14 | |||||
Percent of warrants exercisable upon closing | 60.00% | |||||
Percent of warrants exercisable upon satisfying certain conditions | 40.00% | |||||
Term loan amount | $ 25,000,000 | |||||
2014 Term Loan | Hercules | Alimera Sciences Limited | ||||||
Class of Warrant or Right [Line Items] | ||||||
Term loan amount | $ 25,000,000 | $ 10,000,000 | ||||
First Loan Amendment | Hercules | Alimera Sciences, Inc. | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase Company's common stock, granted during period (in shares) | 660,377 | |||||
Exercise price on warrants (in dollars per share) | $ 2.65 | |||||
July 2016 Waiver | Hercules | Alimera Sciences, Inc. | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase Company's common stock, granted during period (in shares) | 1,258,993 | |||||
Exercise price on warrants (in dollars per share) | $ 1.39 | |||||
Fourth Loan Amendment | Hercules | Alimera Sciences Limited | ||||||
Class of Warrant or Right [Line Items] | ||||||
Warrants to purchase Company's common stock, granted during period (in shares) | 458,716 | |||||
Exercise price on warrants (in dollars per share) | $ 1.09 | |||||
Amount used In calculation of exercise price | $ 500,000 |
Concentrations and Credit Risk
Concentrations and Credit Risk (Details) - customer | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Customer concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk, number of customers | 3 | 3 |
Revenue | Customer concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk, number of customers | 2 | 2 |
Concentration risk percentage | 73.00% | 75.00% |
Accounts receivable | Customer concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk, number of customers | 2 | 2 |
Concentration risk percentage | 81.00% | 90.00% |
Purchases | Supplier concentration risk | ||
Concentration Risk [Line Items] | ||
Concentration risk percentage | 10.50% | |
Concentration risk, number of vendors | 1 | 0 |
Income Taxes - Components of Ne
Income Taxes - Components of Net Loss before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (1,890) | $ (8,516) |
Foreign | (19,948) | (24,486) |
Loss before provision for income taxes | $ (21,838) | $ (33,002) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Current Income Tax Expense (Benefit), Continuing Operations [Abstract] | ||
Federal | $ 0 | $ 0 |
State | 0 | 0 |
Foreign | 255 | 385 |
Current income tax expense | 255 | 385 |
Deferred benefit (expense): | ||
Federal | 549 | 3,099 |
State | 3,330 | (858) |
Foreign | (92) | (213) |
Deferred benefit (expense), gross | 3,787 | 2,028 |
Valuation allowance | (3,879) | (2,241) |
Deferred income tax benefit | (92) | (213) |
Total income tax expense | $ 163 | $ 172 |
Income Taxes - Valuation Allowa
Income Taxes - Valuation Allowance Rollforward (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | $ (55,968,000) | |
Ending balance | (41,485,000) | $ (55,968,000) |
Deferred Tax Asset Valuation Allowance | ||
Valuation and Qualifying Accounts Disclosure [Line Items] | ||
Beginning balance | (55,968,000) | (53,727,000) |
Income tax provision | (3,879,000) | (2,241,000) |
U.S. Tax Reform | 18,362,000 | 0 |
Ending balance | $ (41,485,000) | $ (55,968,000) |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Liabilities) (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets | ||
Depreciation and amortization | $ 44 | $ 12 |
Other deferred tax assets | 707 | 1,164 |
NOL carry-forwards | 33,980 | 38,183 |
Research and development costs | 1,340 | 3,063 |
Equity compensation | 3,686 | 4,660 |
Collaboration agreement receivable reserves | 2,256 | 9,327 |
Valuation allowance | 41,485 | 55,968 |
Total deferred tax assets | 528 | 441 |
Deferred tax liabilities | ||
Other deferred tax liabilities | 0 | (5) |
Total deferred tax liabilities | 0 | (5) |
Net deferred tax assets and deferred tax liabilities | $ 528 | |
Net deferred tax assets and deferred tax liabilities | $ 436 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Tax Benefit to Amount Determined by Applying U.S. Federal Statutory Income Tax Rate (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Amount | ||
Federal tax benefit at statutory rate | $ (7,425) | $ (11,219) |
State tax — net of federal benefit | 3,783 | 10 |
Permanent items and other | 686 | (225) |
Foreign rate differential | 6,880 | 8,470 |
U.S. tax reform | 18,362 | 0 |
Deferred rate change | (212) | 825 |
Other | 138 | 90 |
Change in valuation allowance | (14,483) | 2,241 |
Total tax expense (benefit) | $ 163 | $ 172 |
Percent | ||
Federal tax benefit at statutory rate | 34.00% | 34.00% |
State tax — net of federal benefit | 17.30% | 0.00% |
Permanent items and other | (3.10%) | 0.70% |
Foreign rate differential | (31.50%) | (26.10%) |
U.S. tax reform | (84.10%) | |
Deferred rate change | 1.00% | (2.50%) |
Other | (0.60%) | (0.30%) |
Change in valuation allowance | 66.30% | (6.30%) |
Total tax expense (benefit) | (0.70%) | (0.50%) |
Income Taxes - Uncertain Tax Po
Income Taxes - Uncertain Tax Positions Rollforward (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Unrecognized tax benefits, beginning balance | $ 59 | $ 46 |
Gross increases - tax positions in current period | 4 | 16 |
Gross increases - tax positions in prior period | 0 | 13 |
Gross decreases - tax positions in prior period | (11) | (16) |
Settlements | 0 | 0 |
Lapse of statute of limitations | 0 | 0 |
Unrecognized tax benefits, ending balance | $ 52 | $ 59 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Loss Carryforwards [Line Items] | |||
Tax Cuts and Jobs Act of 2017, incomplete accounting, change in tax rate, deferred tax liability, provisional income tax benefit | $ 0 | ||
Unrecognized tax benefits | 52,000 | $ 59,000 | $ 46,000 |
Operating loss carryforwards, not utilized in the future | 18,600,000 | ||
Federal tax credits, not utilized in the future | 382,000 | ||
Cumulative book losses in foreign subsidiaries | $ (113,278,000) | ||
Transition tax for accumulated foreign earnings, liquid assets, percentage | 15.50% | ||
Transition tax for accumulated foreign earnings, illiquid assets, percentage | 8.00% | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forwards | $ 121,413,000 | 104,944,000 | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forwards | $ 161,753,000 | $ 83,270,000 |
Fair Value (Detail)
Fair Value (Detail) - Recurring basis $ in Thousands | Dec. 31, 2016USD ($) | |
Liabilities: | ||
Derivative warrant liability | $ 188 | [1] |
Liabilities measured at fair value | 188 | |
Level 1 | ||
Liabilities: | ||
Derivative warrant liability | 0 | [1] |
Liabilities measured at fair value | 0 | |
Level 2 | ||
Liabilities: | ||
Derivative warrant liability | 188 | [1] |
Liabilities measured at fair value | 188 | |
Level 3 | ||
Liabilities: | ||
Derivative warrant liability | 0 | [1] |
Liabilities measured at fair value | $ 0 | |
[1] | The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments. Assumptions used are generally consistent with those disclosed for stock-based compensation (see Note 12). |
Employee Benefit Plans (Detail)
Employee Benefit Plans (Detail) | Jan. 01, 2018shares | Jan. 01, 2017shares | Apr. 30, 2010USD ($)periodshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($)shares |
Defined Benefit Plan Disclosure [Line Items] | |||||
Compensation expense associated with the Company's matching plan | $ | $ 187,000 | $ 287,000 | |||
Annual discretionary profit-sharing contribution | $ | 0 | 0 | |||
Compensation expense recorded in connection with the Purchase Plan | $ | $ 4,981,000 | $ 4,889,000 | |||
Employee stock purchase plan | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Purchase price of stock under ESPP as a percentage of fair market value of common stock | 85.00% | 85.00% | |||
Employee stock purchase plan, number of purchase periods | period | 2 | ||||
Employee stock purchase plan, purchase period | 6 months | ||||
Percentage of eligible compensation that may be contributed towards ESPP | 15.00% | ||||
Maximum number of shares of common stock a participant may purchase per purchase period | shares | 2,500 | ||||
Maximum value of shares of common stock a participant may purchase in any calendar year | $ | $ 25,000 | ||||
Common stock, available for sale under employee stock purchase plan | shares | 494,422 | ||||
Common shares acquired through employee stock purchase plan | shares | 79,733 | 82,760 | |||
Additional shares that became available for future issuance under the Purchase Plan | shares | 82,760 | ||||
Compensation expense recorded in connection with the Purchase Plan | $ | $ 38,000 | $ 80,000 | |||
Employee stock purchase plan | Subsequent event | |||||
Defined Benefit Plan Disclosure [Line Items] | |||||
Additional shares that became available for future issuance under the Purchase Plan | shares | 79,733 |
Segment Information Narrative (
Segment Information Narrative (Details) - Customer concentration risk - customer | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Segment Reporting Information [Line Items] | ||
Concentration risk, number of customers | 3 | 3 |
Revenue | ||
Segment Reporting Information [Line Items] | ||
Concentration risk, number of customers | 2 | 2 |
Concentration risk percentage | 73.00% | 75.00% |
Accounts receivable | ||
Segment Reporting Information [Line Items] | ||
Concentration risk, number of customers | 2 | 2 |
Concentration risk percentage | 81.00% | 90.00% |
Selected Quarterly Financial 76
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||
NET REVENUE | $ 9,142 | $ 9,784 | $ 10,368 | $ 6,618 | $ 10,677 | $ 8,298 | $ 9,557 | $ 5,801 | $ 35,912 | $ 34,333 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,043) | (1,039) | (769) | (587) | (924) | (486) | (556) | (378) | (3,438) | (2,344) |
GROSS PROFIT | 8,099 | 8,745 | 9,599 | 6,031 | 9,753 | 7,812 | 9,001 | 5,423 | 32,474 | 31,989 |
NET LOSS FROM OPERATIONS | (5,738) | (3,825) | (1,378) | (5,511) | (5,365) | (7,243) | (6,449) | (8,790) | (16,452) | (27,847) |
NET LOSS | (7,154) | (5,262) | (2,713) | (6,709) | (5,838) | (9,212) | (6,816) | (11,136) | $ (22,001) | $ (33,174) |
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ (7,224) | $ (5,285) | $ (2,757) | $ (6,735) | $ (5,926) | $ (9,245) | $ (6,858) | $ (11,145) | ||
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS — Basic and diluted (in dollars per share) | $ (0.10) | $ (0.08) | $ (0.04) | $ (0.10) | $ (0.09) | $ (0.16) | $ (0.15) | $ (0.25) | $ (0.33) | $ (0.63) |
Segment Information (Details)
Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | |
Segment Reporting Information [Line Items] | ||||||||||
NET REVENUE | $ 9,142 | $ 9,784 | $ 10,368 | $ 6,618 | $ 10,677 | $ 8,298 | $ 9,557 | $ 5,801 | $ 35,912 | $ 34,333 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,043) | (1,039) | (769) | (587) | (924) | (486) | (556) | (378) | (3,438) | (2,344) |
GROSS PROFIT | 8,099 | 8,745 | 9,599 | 6,031 | 9,753 | 7,812 | 9,001 | 5,423 | 32,474 | 31,989 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 12,844 | 12,375 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 13,039 | 15,263 | ||||||||
SALES AND MARKETING EXPENSES | 23,210 | 29,431 | ||||||||
DEPRECIATION AND AMORTIZATION | 2,684 | 2,767 | ||||||||
RECOVERABLE COLLABORATION COSTS | (2,851) | 0 | ||||||||
OPERATING EXPENSES | 48,926 | 59,836 | ||||||||
NET LOSS FROM OPERATIONS | $ (5,738) | $ (3,825) | $ (1,378) | $ (5,511) | $ (5,365) | $ (7,243) | $ (6,449) | $ (8,790) | (16,452) | (27,847) |
OTHER INCOME AND EXPENSES, NET | (5,386) | (5,155) | ||||||||
NET LOSS BEFORE TAXES | (21,838) | (33,002) | ||||||||
U.S. | ||||||||||
Segment Reporting Information [Line Items] | ||||||||||
NET REVENUE | 26,146 | 25,765 | ||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (2,482) | (1,694) | ||||||||
GROSS PROFIT | 23,664 | 24,071 | ||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 5,780 | 7,183 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 7,580 | 8,918 | ||||||||
SALES AND MARKETING EXPENSES | 16,588 | 21,252 | ||||||||
DEPRECIATION AND AMORTIZATION | 0 | 0 | ||||||||
RECOVERABLE COLLABORATION COSTS | 0 | |||||||||
OPERATING EXPENSES | 29,948 | 37,353 | ||||||||
NET LOSS FROM OPERATIONS | (6,284) | (13,282) | ||||||||
International | ||||||||||
Segment Reporting Information [Line Items] | ||||||||||
NET REVENUE | 9,766 | 8,568 | ||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (956) | (650) | ||||||||
GROSS PROFIT | 8,810 | 7,918 | ||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,314 | 4,289 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 2,605 | 3,517 | ||||||||
SALES AND MARKETING EXPENSES | 5,394 | 7,021 | ||||||||
DEPRECIATION AND AMORTIZATION | 0 | 0 | ||||||||
RECOVERABLE COLLABORATION COSTS | 0 | |||||||||
OPERATING EXPENSES | 11,313 | 14,827 | ||||||||
NET LOSS FROM OPERATIONS | (2,503) | (6,909) | ||||||||
Other Segments | ||||||||||
Segment Reporting Information [Line Items] | ||||||||||
NET REVENUE | 0 | 0 | ||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | 0 | 0 | ||||||||
GROSS PROFIT | 0 | 0 | ||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 3,750 | 903 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 2,854 | 2,828 | ||||||||
SALES AND MARKETING EXPENSES | 1,228 | 1,158 | ||||||||
DEPRECIATION AND AMORTIZATION | 2,684 | 2,767 | ||||||||
RECOVERABLE COLLABORATION COSTS | (2,851) | |||||||||
OPERATING EXPENSES | 7,665 | 7,656 | ||||||||
NET LOSS FROM OPERATIONS | $ (7,665) | $ (7,656) |
Subsequent Events Narrative (De
Subsequent Events Narrative (Details) | Jan. 05, 2018USD ($) |
2018 Loan Agreement | Solar Capital Ltd. | Subsequent event | |
Subsequent Event [Line Items] | |
Amount borrowed under loan agreement | $ 40,000,000 |