Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 11, 2016 | Jun. 30, 2015 | |
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, 2015 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2,015 | ||
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 | Accelerated Filer | ||
Entity Public Float | $ 163,896,140 | ||
Entity Common Stock, Shares Outstanding | 45,005,833 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 31,075 | $ 76,697 |
Restricted cash | 37 | 0 |
Accounts receivable, net | 9,799 | 850 |
Prepaid expenses and other current assets | 2,696 | 3,234 |
Inventory, net (Note 4) | 1,552 | 1,734 |
Total current assets | 45,159 | 82,515 |
Property and equipment — at cost less accumulated depreciation | 2,553 | 1,653 |
Intangible asset, net | 22,549 | 24,490 |
Deferred tax asset | 223 | 0 |
TOTAL ASSETS | 70,484 | 108,658 |
CURRENT LIABILITIES: | ||
Accounts payable | 4,002 | 5,021 |
Accrued expenses (Note 7) | 3,594 | 954 |
Accrued milestone payments | 0 | 2,000 |
Outsourced services payable | 317 | 1,466 |
Note payable (Note 9) | 31,786 | 1,023 |
Capital lease obligations | 234 | 11 |
Total current liabilities | 39,933 | 10,475 |
NON-CURRENT LIABILITIES: | ||
Derivative warrant liability | 2,815 | 16,098 |
Note payable — less current portion (Note 9) | 0 | 32,311 |
Capital lease obligations — less current portion | 582 | 8 |
Other non-current liabilities | $ 834 | $ 247 |
COMMITMENTS AND CONTINGENCIES (Note 10) | ||
STOCKHOLDERS’ EQUITY: | ||
Common stock, $.01 par value — 100,000,000 shares authorized, 45,005,833 shares issued and outstanding at December 31, 2015 and 44,320,342 shares issued and outstanding at December 31, 2014 | $ 450 | $ 443 |
Additional paid-in capital | 299,376 | 292,851 |
Accumulated deficit | (343,900) | (313,255) |
Accumulated other comprehensive loss | (1,148) | (812) |
TOTAL STOCKHOLDERS’ EQUITY | 26,320 | 49,519 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ 70,484 | $ 108,658 |
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 warrants | $ 2,747 | $ 1,497 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
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 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 45,005,833 | 44,320,342 |
Common stock, shares outstanding | 45,005,833 | 44,320,342 |
Series A convertible preferred stock | ||
Preferred stock, shares authorized | 1,300,000 | 1,300,000 |
Preferred stock, shares issued | 600,000 | 600,000 |
Preferred stock, shares outstanding | 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 | 8,416.251 | 8,416.251 |
Preferred stock, shares outstanding | 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, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Statement [Abstract] | |||
NET REVENUE | $ 22,438 | $ 8,423 | $ 1,872 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,762) | (1,442) | (1,863) |
GROSS PROFIT | 20,676 | 6,981 | 9 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 14,840 | 11,811 | 8,858 |
GENERAL AND ADMINISTRATIVE EXPENSES | 14,190 | 12,371 | 9,475 |
SALES AND MARKETING EXPENSES | 28,090 | 15,087 | 15,942 |
DEPRECIATION AND AMORTIZATION | 2,555 | 659 | 138 |
OPERATING EXPENSES | 59,675 | 39,928 | 34,413 |
NET LOSS FROM OPERATIONS | (38,999) | (32,947) | (34,404) |
INTEREST EXPENSE AND OTHER | (4,693) | (2,090) | (533) |
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET | (106) | (542) | 825 |
LOSS ON EARLY EXTINGUISHMENT OF DEBT | 0 | (440) | (153) |
CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | 13,283 | 283 | (11,964) |
NET LOSS BEFORE TAXES | (30,515) | (35,736) | (46,229) |
PROVISION FOR TAXES | (130) | (174) | 0 |
NET LOSS | (30,645) | (35,910) | (46,229) |
BENEFICIAL CONVERSION FEATURE OF PREFERRED STOCK (Note 11) | 0 | (750) | (4,950) |
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ (30,645) | $ (36,660) | $ (51,179) |
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS — Basic and diluted (in dollars per share) | $ (0.69) | $ (0.91) | $ (1.62) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted (in shares) | 44,450,216 | 40,397,224 | 31,579,553 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (30,645) | $ (35,910) | $ (46,229) |
OTHER COMPREHENSIVE LOSS | |||
Foreign currency translation adjustments | (336) | (324) | (488) |
TOTAL OTHER COMPREHENSIVE LOSS | (336) | (324) | (488) |
COMPREHENSIVE LOSS | $ (30,981) | $ (36,234) | $ (46,717) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' (Deficit) 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, 2012 | $ 39,144 | $ 315 | $ 32,045 | $ 0 | $ 237,485 | $ 415 | $ (231,116) | $ 0 | |||
BALANCE (in shares) at Dec. 31, 2012 | 31,541,286 | 1,000,000 | 0 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of stock, net of issuance costs | $ 53 | $ 0 | $ 53 | ||||||||
Issuance of stock, net of issuance costs (in shares) | 26,123 | ||||||||||
Exercise of stock options | $ 72 | $ 1 | 71 | ||||||||
Exercise of stock options (in shares) | 43,582 | 43,582 | |||||||||
Modification of common stock warrants | $ 46 | 46 | |||||||||
Forfeiture of common stock warrants | 49 | (49) | |||||||||
Intrinsic value of beneficial conversion feature | $ (4,950) | 4,950 | |||||||||
Accretion of beneficial conversion feature | (4,950) | 4,950 | (4,950) | ||||||||
Stock-based compensation expense | 2,477 | 2,477 | |||||||||
Net loss | (46,229) | (46,229) | |||||||||
Foreign currency translation adjustments | (488) | (488) | |||||||||
BALANCE at Dec. 31, 2013 | (4,925) | $ 316 | $ 32,045 | $ 0 | 240,135 | 412 | (277,345) | (488) | |||
BALANCE (in shares) at Dec. 31, 2013 | 31,610,991 | 1,000,000 | 0 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of stock, net of issuance costs | 49,568 | 35,209 | $ 63 | $ 49,568 | 35,146 | ||||||
Issuance of stock, net of issuance costs (in shares) | 6,284,915 | 8,416 | |||||||||
Exercise of stock options | $ 774 | $ 4 | 770 | ||||||||
Exercise of stock options (in shares) | 391,307 | 391,307 | |||||||||
Issuance of common stock warrants | $ 1,277 | 1,277 | |||||||||
Conversion of preferred stock | $ 60 | $ (12,818) | 12,758 | ||||||||
Conversion of preferred stock (in shares) | 6,015,037 | (400,000) | |||||||||
Exercise of common stock warrants (in shares) | 18,092 | ||||||||||
Exercise of common stock warrants | 192 | (192) | |||||||||
Intrinsic value of beneficial conversion feature | $ (750) | 750 | |||||||||
Accretion of beneficial conversion feature | (750) | 750 | (750) | ||||||||
Stock-based compensation expense | 3,850 | 3,850 | |||||||||
Net loss | (35,910) | (35,910) | |||||||||
Foreign currency translation adjustments | (324) | (324) | |||||||||
BALANCE at Dec. 31, 2014 | 49,519 | $ 443 | $ 19,227 | $ 49,568 | 292,851 | 1,497 | (313,255) | (812) | |||
BALANCE (in shares) at Dec. 31, 2014 | 44,320,342 | 600,000 | 8,416 | ||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Issuance of stock, net of issuance costs | $ 924 | $ 4 | $ 920 | ||||||||
Issuance of stock, net of issuance costs (in shares) | 341,239 | ||||||||||
Exercise of stock options | $ 571 | $ 3 | 568 | ||||||||
Exercise of stock options (in shares) | 344,252 | 344,252 | |||||||||
Modification of common stock warrants | $ 1,250 | 1,250 | |||||||||
Accretion of beneficial conversion feature | 0 | ||||||||||
Stock-based compensation expense | 5,037 | 5,037 | |||||||||
Net loss | (30,645) | (30,645) | |||||||||
Foreign currency translation adjustments | (336) | (336) | |||||||||
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 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (30,645) | $ (35,910) | $ (46,229) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 2,555 | 659 | 138 |
Inventory reserve | 445 | 857 | 410 |
Unrealized foreign currency transaction loss (gain) | 106 | 542 | (825) |
Amortization of debt discount | 836 | 466 | 159 |
Deferred taxes (benefit) | (223) | 0 | 0 |
Loss on early extinguishment of debt | 0 | 440 | 153 |
Stock compensation expense | 5,037 | 3,850 | 2,477 |
Change in fair value of derivative warrant liability | (13,283) | (283) | 11,964 |
Changes in assets and liabilities: | |||
Accounts receivable | (8,919) | (444) | (483) |
Prepaid expenses and other current assets | 405 | 206 | (1,355) |
Inventory | (386) | (992) | (1,416) |
Accounts payable | (487) | 2,987 | (259) |
Accrued expenses and other current liabilities | (1,401) | 3,077 | (2,347) |
Other long-term liabilities | 596 | 244 | (208) |
Net cash used in operating activities | (45,364) | (24,301) | (37,821) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Payment of license intangible (Note 6) | 0 | (25,000) | 0 |
Purchases of property and equipment | (451) | (842) | (973) |
Net cash used in investing activities | (451) | (25,842) | (973) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercise of stock options | 571 | 774 | 72 |
Proceeds from sale of common stock | 1,002 | 37,598 | 53 |
Payment of issuance cost of common stock | (27) | (2,389) | 0 |
Proceeds from issuance of Series B convertible preferred stock | 0 | 50,000 | 0 |
Payment of Series B convertible preferred stock offering costs | (327) | (105) | 0 |
Proceeds from issuance of notes payable (Note 9) | 0 | 35,000 | 5,000 |
Payment of debt issuance costs (Note 9) | (264) | (1,016) | (291) |
Payment of principal on notes payable | 0 | (4,861) | (3,169) |
Payment of debt extinguishment costs | 0 | (246) | 0 |
Payments on capital lease obligations | (293) | (10) | (11) |
Changes in restricted cash | (37) | 0 | 0 |
Net cash provided by financing activities | 625 | 114,745 | 1,654 |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS | (432) | (533) | 204 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (45,622) | 64,069 | (36,936) |
CASH AND CASH EQUIVALENTS — Beginning of year | 76,697 | 12,628 | 49,564 |
CASH AND CASH EQUIVALENTS — End of year | 31,075 | 76,697 | 12,628 |
SUPPLEMENTAL DISCLOSURES: | |||
Cash paid for interest | 4,177 | 1,247 | 607 |
Cash paid for income taxes | 263 | 0 | 0 |
Supplemental schedule of noncash investing and financing activities: | |||
Property and equipment acquired under capital leases | 1,098 | 0 | 33 |
Note payable end of term payment accrued but unpaid | 1,050 | 0 | 0 |
Conversion of Series A Convertible Preferred Stock to common stock | 0 | 12,818 | 0 |
Common Stock | |||
Supplemental schedule of noncash investing and financing activities: | |||
Stock offering costs accrued but unpaid | 52 | 0 | 0 |
Series B convertible preferred stock | |||
Supplemental schedule of noncash investing and financing activities: | |||
Stock offering costs accrued but unpaid | $ 0 | $ 327 | $ 0 |
Nature of Operations
Nature of Operations | 12 Months Ended |
Dec. 31, 2015 | |
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 research, development, and commercialization 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 these countries, the Company has committed to conduct a five -year, post-authorization, open label registry study in 800 patients treated with ILUVIEN per the labeled indication. The Company launched ILUVIEN in Germany and the United Kingdom in the second quarter of 2013 and in the U.S. and Portugal in the first quarter of 2015. In addition, we have entered into various agreements under which distributors will provide regulatory, reimbursement or sales and marketing support for future commercialization of ILUVIEN in numerous countries in the Middle East, Canada, Italy and Australia. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The following accounting policies relate primarily to the continuing operations of the Company: 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. Reclassifications — Within the operating expenses section of the Consolidated Statements of Operations for the year ended December 31, 2013, the Company reclassified depreciation expense of $138,000 from general and administrative expenses to depreciation and amortization to conform to the current year presentation. In addition, the Company reclassified certain medical affairs support expenses of $448,000 and $429,000 for the years ended December 31, 2014 and 2013, respectively, from sales and marketing expenses to research, development and medical affairs expenses. Cash, Cash Equivalents and Restricted Cash — Cash and cash equivalents include cash and 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. The Company limits its exposure to credit loss by placing its cash and cash equivalents in highly liquid investments with high quality financial institutions. Cash and cash equivalents were $31,075,000 and $76,697,000 at December 31, 2015 and 2014, respectively, with approximately 90.0% and 96.0% of these balances, respectively held in U.S. based financial institutions. In addition, the Company has certain credit arrangements that require the Company to maintain minimum balances in specific bank accounts as collateral and are restricted cash. Revenue Recognition — 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 shipment or upon receipt by the customer depending on the agreement with 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 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 from U.S. product sales is recorded upon sale to the pharmaceutical distributors net of applicable provisions for rebates and chargebacks under governmental programs, distribution-related fees and other sales-related 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. The Company estimates reductions to product sales for Medicaid and Veterans’ Administration (VA) programs and for certain other qualifying federal and state government programs. Based upon the Company’s contracts with government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience and estimated payer mix, the Company estimates and records an allowance for rebates and chargebacks. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make for a current quarter, claims for prior quarters that have been estimated for which an invoice has not been received and invoices received for claims from prior quarters that have not been paid. The Company’s reserves related to discounted pricing to VA, Public Health Services and other institutions (collectively qualified healthcare providers) represent the Company’s estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., pharmaceutical distributors). The Company’s customers charge the Company for the difference between what they pay for the products and the ultimate selling price to the qualified healthcare providers. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the historical chargebacks that customers have already claimed. The Company has written contracts with its customers that include terms for distribution-related fees. The Company estimates and records distribution and related fees due to its customers based on gross sales. Consistent with industry practice, the Company offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product’s expiration date. The Company will accept returns for three months prior to and up to nine months after the product expiration date. Depending on the circumstances, the Company may provide replacement products or cash credit for returns. Product returned is generally not resalable given the nature of the Company’s products and method of administration. The Company develops estimates for product returns based upon historical experience, inventory levels, shelf life of the product and other relevant factors. The Company monitors product supply levels in the distribution channel, as well as sales by its customers to healthcare providers using product-specific data provided by its customers. If necessary, the Company’s estimates of product returns may be adjusted in the future based on actual returns experience, known or expected changes in the marketplace, or other factors. Accounts Receivable and Allowance for Doubtful Accounts — Accounts receivable are generated through sales primarily to pharmacies, hospitals and wholesalers which began in 2013. 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. The following summarizes activity related to the Company ’ s allowance for doubtful accounts: Years Ended December 31, 2015 2014 2013 (in thousands) Beginning balance $ — $ — $ — Bad debt expense 118 21 — Write-offs — (21 ) — Ending balance $ 118 $ — $ — 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. If the actual net realizable value is less than that estimated, or if there are any further determinations that inventory will not be marketable based on estimates of demand, additional inventory write-downs will be required. 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 estimated useful life of the intangible asset is approximately thirteen years . 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 and fixtures and manufacturing equipment, five years ; automobiles, four years ; office equipment and leasehold improvements, 29 months to five years ; and software, three years . Impairment — Property and equipment and 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 — In accordance with the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 740, Income Taxes , the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position; therefore, no ASC 740-10 liabilities have been recorded. The Company will recognize accrued interest and penalties related to unrecognized tax benefits, if any, as interest expense and income tax expense, respectively, in the consolidated statements of operations. 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 as a result of the Company ’ s history of operating losses, a valuation allowance has been established against the net deferred tax asset balance in the U.S. 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. Research and Development Costs — Research and development costs are expensed as incurred. Research and development expenses were $2,745,000 , $7,594,000 and $3,904,000 for the years ended December 31, 2015, 2014 and 2013, respectively. Stock-Based Compensation — The Company has stock option plans which provide for grants of stock options to employees and directors to purchase shares of the Company’s common stock at exercise prices generally equal to the fair market values of such stock at the dates of grant. Compensation cost is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of 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, are 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. At December 31, 2015 and 2014, these warrants represented the only outstanding derivative instruments issued or held by the Company. 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 - The U.S. dollar is the functional currency for Alimera Sciences, Inc. The Euro is the functional currency for the majority of the Company ’ s subsidiaries operating outside of the U.S. For Alimera Sciences, Inc., foreign currency assets and liabilities are remeasured into U.S. dollars at end-of-period exchange rates, except for non-monetary balance sheet accounts, which are remeasured at historical exchange rates. Revenue and expenses are remeasured at average exchange rates in effect during each period, except for those expenses related to the non-monetary balance sheet amounts, which are remeasured at historical exchange rates. Gains or losses from foreign currency remeasurements are included in the statement of operations. The financial statements of the foreign subsidiaries whose functional currency is not the U.S. dollar, have been translated into U.S. dollars in accordance with ASC 830-30, Translation of Financial Statements . For the subsidiaries operating outside of the U.S. that are denominated in the Euro, assets and liabilities are translated at end-of-period rates while revenues and expenses are translated at average rates in effect during the period in which the activity took place. Equity is translated at historical rates and the resulting cumulative translation adjustments are included as a component of accumulated other comprehensive loss. 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, 2015 2014 2013 Series A convertible preferred stock 9,022,556 9,022,556 15,037,594 Series B convertible preferred stock 8,416,251 8,416,251 — Series A convertible preferred stock warrants 4,511,279 4,511,279 4,511,279 Common stock warrants 738,331 362,970 109,772 Stock options 9,475,890 7,681,256 7,566,437 Total 32,164,307 29,994,312 27,225,082 Reporting Segments — The Company determines operating 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 upon net loss from operations. 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 two reportable segments, U.S. and International. Promotional and Advertising Costs — Promotional and advertising costs are expensed as incurred. Adoption of New Accounting Standards — In April 2015, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs . ASU 2015-03 is intended to simplify the presentation of debt issuance costs. These amendments require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the amendments in this ASU. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted and the standard is to be retrospectively applied to all periods presented upon adoption. The Company elected to early adopt ASU 2015-03 effective December 31, 2015, and as a result reclassified $629,000 and $754,000 from deferred financing costs to note payable, net of discount in its Consolidated Balance Sheet as of December 31, 2015 and 2014, respectively. In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes , which simplifies the presentation of deferred income taxes. This ASU requires that deferred tax assets and liabilities be classified as non-current in a statement of financial position. The Company elected to early adopt ASU 2015-17 effective December 31, 2015 on a prospective basis. Adoption of this ASU resulted in a reclassification of our net current deferred tax asset to the net non-current deferred tax asset in its Consolidated Balance Sheet as of December 31, 2015. No prior periods were retrospectively adjusted. Accounting Standards Issued But Not Yet Effective — In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) . ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard will be effective for the first interim period within annual reporting periods beginning after December 15, 2017 for public entities, with early adoption permitted in the annual reporting period beginning after December 15, 2016. The Company is still evaluating the potential impact of adopting this guidance on its financial statements. In June 2014, the FASB issued ASU 2014-12, Compensation Stock - Compensation (Topic 718) . ASU 2014-12 applies to all reporting entities that grant their employees share-based payments in which the terms of the award provide that a performance target that affects vesting could be achieved after the requisite service period. It requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition and follows existing accounting guidance for the treatment of performance conditions. The standard will be effective for annual periods and interim periods within those annual periods beginning after December 15, 2015, with early adoption permitted. The Company does not expect there to be a material impact upon adopting this guidance on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted. The Company does not expect there to be a material impact upon adopting this guidance on its financial statements. |
Factors Affecting Operations
Factors Affecting Operations | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
FACTORS AFFECTING OPERATIONS | FACTORS AFFECTING OPERATIONS To date the Company has incurred recurring losses, negative cash flow from operations, and has accumulated a deficit of $343,900,000 from the Company’s inception through December 31, 2015 . As of December 31, 2015 , the Company had approximately $31,075,000 in cash and cash equivalents. Due to the limited revenue generated by ILUVIEN to date, the Company may have to raise additional capital to fund the continued commercialization of ILUVIEN. If the Company is unable to raise additional financing, the Company will need to adjust its commercial plans so that the Company can continue to operate with its existing cash resources. The actual amount of funds that the Company will need will be determined by many factors, some of which are beyond its control and the Company may need funds sooner than currently anticipated. In January 2016, the Company did not meet a revenue threshold under the covenants of the Company's note payable. While this violation was waived, the Company’s current financial forecast for 2016 projects that the Company must obtain alternative or additional financing or it is probable that the Company will not be in compliance with the liquidity covenant. While these financial covenant requirements may be waived in the future, there can be no certainty that this will be the case. The Company is currently pursuing alternative or additional debt financing and has an at-the-market offering in place under which it can sell up to approximately $34,175,000 of its common stock. If the Company is not successful, it will be in default under its loan agreement. In an event of default, all amounts may become due under our loan agreement and there would be substantial doubt about our ability to continue as a going concern. (See Note 9 Loan Agreements). The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company ’ s recurring net losses, negative cash flow from operations and accumulated deficit raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |
INVENTORY | INVENTORY Inventory consisted of the following: December 31, 2015 2014 (In thousands) Component parts (1) $ 131 $ 76 Work-in-process (2) 333 219 Finished goods 1,525 1,972 Total inventory 1,989 2,267 Inventory reserve (437 ) (533 ) Inventory — net $ 1,552 $ 1,734 (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, 2015 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | PROPERTY AND EQUIPMENT Property and equipment consisted of the following: December 31, 2015 2014 (In thousands) Furniture and fixtures $ 376 $ 367 Office equipment 794 652 Automobiles 1,028 — Software 902 601 Leasehold improvements 439 417 Manufacturing equipment 970 974 Total property and equipment 4,509 3,011 Less accumulated depreciation and amortization (1,956 ) (1,358 ) Property and equipment — net $ 2,553 $ 1,653 Depreciation and amortization expense associated with property and equipment totaled $614,000 , $149,000 and $138,000 for the years ended December 31, 2015 , 2014 and 2013 , respectively. |
Intangible Assets
Intangible Assets | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
INTANGIBLE ASSETS | INTANGIBLE ASSETS The Company had no intangible assets as of December 31, 2013. As a result of the Food and Drug Administration ’ s (FDA) approval of ILUVIEN in September 2014, the Company was required to pay pSivida US, Inc. (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 $22,549,000 and $24,490,000 as of December 31, 2015 and 2014, respectively, and amortization expense was $1,941,000 and $510,000 for the years ended December 31, 2015 and 2014, respectively. The estimated remaining amortization as of December 31, 2015 is as follows (in thousands): Years Ending December 31 2016 $ 1,940 2017 1,940 2018 1,940 2019 1,940 2020 1,940 Thereafter 12,849 Total $ 22,549 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2015 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2015 2014 (In thousands) Accrued clinical investigator expenses $ 732 $ 309 Accrued other compensation expenses 804 226 Accrued rebate, chargeback and other revenue reserves 452 — Accrued End of Term Payment (Note 9) 1,050 — Other accrued expenses 556 419 Total accrued expenses $ 3,594 $ 954 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LICENSE AGREEMENTS | LICENSE AGREEMENTS The Company entered into an agreement with pSivida for the use of fluocinolone acetonide (FAc) in pSivida’s proprietary delivery device in February 2005, and a subsequent amendment in 2008. pSivida is a global drug delivery company committed to the biomedical sector and the development of drug delivery products. The agreement with pSivida provides the Company with a worldwide exclusive license to develop and sell ILUVIEN. The Company’s license rights to pSivida’s proprietary delivery device 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 its agreement with pSivida 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 delivery device. The Company was not in breach of its agreement with pSivida as of December 31, 2015. Upon commercialization of ILUVIEN, the Company must share 20% of net profits, determined on a cash basis, and 33% of any lump sum milestone payments received from a sub-licensee of ILUVIEN, as defined by the agreement, with pSivida. In connection with this arrangement the Company is entitled to recover 20% of commercialization costs of ILUVIEN, as defined in the agreement, incurred prior to product profitability out of pSivida’s share of net profits, which is recovered as a reduction of future royalty payments. As of December 31, 2015 and 2014 , the Company was owed $21,565,000 and $12,956,000 , respectively, in commercialization costs. Due to the uncertainty of future net profits, the Company has fully reserved these amounts in the accompanying consolidated financial statements. As a result of the FDA ’ s approval of ILUVIEN in September 2014, the Company paid pSivida a milestone payment of $25,000,000 in October 2014. |
Loan Agreements
Loan Agreements | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
LOAN AGREEMENTS | LOAN AGREEMENTS 2013 Loan Agreement In May 2013, Alimera Sciences Limited (Limited), a subsidiary of the Company, entered into a loan and security agreement (2013 Loan Agreement) with SVB to provide Limited with additional working capital for general corporate purposes. Under the 2013 Loan Agreement, SVB has made a term loan (2013 Term Loan) in the principal amount of $5,000,000 to Limited and has agreed to provide up to an additional $15,000,000 to Limited under a working capital line of credit (2013 Line of Credit). As a result of entering into the 2013 Loan Agreement, in May 2013, the Company repaid all amounts owed to lenders under the previous term loan and in accordance with ASC 470-50-40-17 Debt - Modifications and Extinguishments (ASC 470-50-40-17) the Company recognized a loss on early extinguishment of debt of $153,000 associated with the remaining unamortized deferred financing costs, unamortized discount, the final interest payment, the prepayment penalty and a lender fee. In April 2014, the 2013 Term Loan was repaid and the 2013 Line of Credit was terminated in connection with the 2014 Loan Agreement described below. Upon repayment of the 2013 Term Loan in April 2014, Limited paid SVB an outstanding loan balance prepayment penalty of $133,000 , and an early termination fee of $113,000 in connection with the termination of the 2013 Line of Credit in April 2014. In addition, in accordance with ASC 470-50-40-17, the Company expensed the facility fee and incremental value of the warrants associated with the 2013 Term Loan as part of the $440,000 loss on early extinguishment. 2014 Loan Agreement, 2015 Loan Amendment and 2016 Loan Amendment In April 2014, Limited entered into a loan and security agreement (2014 Loan Agreement) with Hercules Technology Growth Capital, Inc. (Hercules) providing for a term loan of up to $35,000,000 (2014 Term Loan), which Limited and Hercules amended in November 2015 (the 2015 Loan Amendment and, together with the 2014 Loan Agreement, the 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 the 2013 Term Loan. Hercules made an additional advance of $25,000,000 to Limited in September 2014 following the approval of ILUVIEN by the FDA in September 2014 to fund the pSivida Milestone Payment. The 2014 Term Loan provided for interest only payments through November 2015. The 2015 Loan Amendment extended the interest only payments through May 2017. Interest on the 2014 Term Loan accrues 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. Beginning in June 2017, Limited will make eleven equal monthly payments of principal and interest based upon a 30 -month amortization schedule followed by a final payment of all remaining outstanding principal and interest in May 2018. In connection with the 2015 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 in May 2018 (End of Term Payment). In connection with the initial advance under the 2014 Term Loan, Limited paid to Hercules a facility charge of $262,500 and incurred legal and other fees of approximately $383,000 . Limited incurred $375,000 in additional fees in connection with the second advance. If Limited repays the Term Loan Agreement prior to maturity, it will pay Hercules a prepayment penalty of 1.25% of the total principal amount repaid. Limited and the Company, on a consolidated basis with its other subsidiaries, also 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 Term Loan Agreement and an increase to the applicable interest rate, and would permit Hercules to exercise remedies with respect to the collateral under the Term Loan Agreement. In connection with the amendment, Limited agreed to covenants regarding certain revenue thresholds and a liquidity threshold of $20,000,000 for the Company of which at least $10,000,000 must be in cash. As of December 31, 2015, the Company, on a consolidated basis with its subsidiaries, was in compliance with the covenants of the Term Loan Agreement. In January 2016, the revenue threshold covenant was not met by the Company. As a result, on March 14, 2016, Limited entered into a second amendment to the Term Loan Agreement (the 2016 Loan Amendment) with Hercules, which waived the covenant violation and amended certain terms of the Term Loan Agreement. The 2016 Loan Amendment amended the revenue covenant to a rolling three month calculation to first be measured for the three months ending May 31, 2016 and increases the liquidity covenant. The amended liquidity covenant requires the Company to keep at least $25,000,000 in liquidity, with a minimum of $17,500,000 in cash. Additionally, in any month in which the Company has $25,000,000 in cash, the revenue requirement will be waived. Upon execution of the 2016 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 is payable on the date that the Term Loan Agreement is paid in full. The Company’s current financial forecast for 2016 projects that the Company must obtain alternative or additional financing or it is probable that the Company will not be able to comply with the liquidity covenant. While Hercules may waive financial covenant requirements in the future, there can be no certainty that this will be the case. The Company is currently pursuing alternatives with various lenders and has an at-the-market offering in place under which it can sell up to approximately $34,175,000 of its common stock. However, the avoidance of noncompliance with the liquidity covenant cannot be assured. If the Company does not maintain compliance with any of its covenants, Hercules could demand immediate repayment in full of the $35,000,000 note payable and the End of Term Payment. As a result, the full amount of the related long-term note payable and the End of Term Payment have been classified as current liabilities in the accompanying Balance Sheet at December 31, 2015. Regardless of the noncompliance with financial covenants, the Company has made every scheduled payment required under the terms of the Term Loan Agreement. Limited’s obligations to Hercules are secured by a first priority security interest in substantially all of Limited’s assets, excluding intellectual property. Hercules does, however, maintain 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 are guarantors of the obligations of Limited to Hercules under the Term Loan Agreement, as amended, 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 Term Loan Agreement also places limitations on the Company ’ s ability to declare or pay any dividend or distribution on any shares of capital stock. In connection with Limited entering into the 2014 Loan Agreement, the Company entered into a warrant agreement with Hercules to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share. The Company estimated the fair value of warrants granted using the Black-Scholes option pricing model to be $1,349,000 . The Company allocated a portion of the proceeds from the 2014 Term Loan to the warrants in accordance with ASC 470-20-25-2, Debt Instruments with Detachable Warrants . As a result, the Company recorded a discount of $1,277,000 which is amortized to interest expense using the effective interest method. 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. Further, the Company agreed to amend the warrant agreement in connection with the 2015 Loan Amendment to increase the number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. The Company recorded the incremental fair value of these warrants of $1,250,000 as a discount which is amortized to interest expense using the effective interest method. In connection with the 2016 Loan Amendment, the Company agreed to amend the warrant agreement to increase the number of shares issuable to 862,069 and decrease the exercise price to $2.03 per share. Fair Value of Debt The weighted average interest rates of the Company ’ s notes payable approximate the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the notes approximated their fair value at December 31, 2015 and 2014. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | COMMITMENTS AND CONTINGENCIES Term Note Payable — The Company entered into the Term Loan Agreement in April 2014 and amended the agreement in November 2015 and March 2016 (Note 9). As of December 31, 2015 a schedule of future minimum principal payments under the Note Payable is as follows (in thousands): Years Ending December 31 (In thousands) 2016 $ 35,000 Total $ 35,000 As of December 31, 2015 and 2014 , the Company had $333,000 and $324,000 accrued and unpaid interest payable on the Notes Payable, respectively. In addition, the Company is required to make an additional payment of $1,050,000 at the time of the final payment in May 2018. 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 from December 17, 2014 to December 24, 2024, however the lease is cancellable after five years. The lease has a contingent escalation clause based on inflation beginning in 2020. The Company also leases office space in France, Germany and Portugal that expire in March 2016, June 2018 and July 2016. At December 31, 2015 , a schedule by year of future minimum payments under operating leases is as follows: Years Ending December 31 (In thousands) 2016 $ 557 2017 567 2018 547 2019 527 2020 350 Thereafter 268 Total $ 2,816 Rent expense under all operating leases totaled approximately $541,000 , $521,000 and $576,000 for the years ended December 31, 2015 , 2014 , and 2013 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. At December 31, 2015 , 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) 2016 $ 396 2017 391 2018 380 2019 117 Total 1,284 Less amount representing interest (96 ) Less amount representing executory costs (372 ) Present value of minimum lease payments 816 Less current portion (234 ) Non-current portion $ 582 Property and equipment under capital leases, which are included in property and equipment (Note 5), consisted of the following: December 31, 2015 2014 (In thousands) Automobiles $ 1,028 $ — Office equipment 63 33 Less accumulated depreciation (212 ) (16 ) Total $ 879 $ 17 Depreciation expense associated with property and equipment under capital leases was approximately $210,000 , $11,000 and $11,000 for the years ended December 31, 2015 , 2014 and 2013 , 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 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 has an initial six year term and will automatically renew for successive one year periods unless either party delivers 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 amended and restated its 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 two 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 800 patients treated with ILUVIEN per the labeled indication in the EEA. Since May of 2013 eight additional agreements have been entered into for work with these CROs. For the years ended December 31, 2015 , 2014 and 2013 , the Company incurred $591,000 , $346,000 and $222,000 , respectively, of expense associated with these agreements. At December 31, 2015 , $150,000 is recorded in outsourced services payable. At December 31, 2014 no amount is included in outsourced services payable. As of December 31, 2015, the Company expects to incur an additional $810,000 of expense associated with these agreements through December 31, 2019. In November 2012, the Company entered into a master services agreement with Quintiles Commercial Europe Limited. Under the agreement, Quintiles Commercial Europe Limited and its affiliates (collectively, Quintiles Commercial) provided certain services to us in relation to the commercialization of ILUVIEN, in France, Germany and the United Kingdom. In December 2013 and January 2014, respectively, the Company transitioned our German and United Kingdom country manager positions in-house. In April 2015, the Company terminated the project orders associated with France and Germany and transitioned the persons employed by Quintiles Commercial to our payroll. In July 2015, the Company terminated the project orders associated with the United Kingdom and transitioned the persons employed by Quintiles Commercial to the Company ’ s payroll. For the years ended December 31, 2015 , 2014 and 2013 , the Company incurred $1,030,000 , $5,800,000 and $7,500,000 , respectively, of expense associated with this agreement. At December 31, 2015 , $170,000 is included in outsourced services payable and no amount is included in prepaid expenses and other current assets. 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, 2016, the Company was party to five agreements with salaries ranging from $303,000 to $519,000 . 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 of salary and benefits. Certain other employees have general employment contracts which include stipulations regarding confidentiality, Company property, and miscellaneous items. |
Preferred Stock
Preferred Stock | 12 Months Ended |
Dec. 31, 2015 | |
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. The powers, preferences and rights of the Series A Convertible Preferred Stock are set forth in the certificate of designation filed by the Company with the Secretary of State of the State of Delaware on October 1, 2012. 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 NDA 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 may be 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 are considered derivative instruments because the agreements provide 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. At December 31, 2015 and 2014 the fair market value of the warrants was estimated to be $2,815,000 and $16,098,000 , respectively. The Company recorded a gain of $13,283,000 and $283,000 as a result of the change in fair value of the warrants during the years ended December 31, 2015 and 2014, respectively. The Company recorded a loss of $11,964,000 as a result of the change in fair value of the warrants during the year ended December 31, 2013. In April 2014, 2,255,639 shares of common stock were issued pursuant to the conversion of 150,000 shares of Series A Convertible Preferred Stock held by an investor. In September 2014, 3,759,398 shares of common stock were issued pursuant to the conversion of 250,000 shares of Series A Convertible Preferred Stock held by another investor. 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 $6,030.00 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 has also agreed to issue the purchasers an additional 124.378 shares of Series B Convertible Preferred Stock as a subscription premium. The powers, preferences and rights of the Series B Convertible Preferred Stock are set forth in the certificate of designation filed by the Company with the Secretary of State of the State of Delaware. 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 will not have voting rights. The Series B 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 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, 2015 | |
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. 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, 2015 2014 2013 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 7,681,256 $ 3.03 7,566,438 $ 2.74 5,493,079 $ 2.67 Grants 2,570,000 4.62 716,500 5.56 2,630,000 2.71 Forfeitures (431,114 ) 4.79 (210,375 ) 3.10 (513,059 ) 1.96 Exercises (344,252 ) 1.66 (391,307 ) 1.97 (43,582 ) 1.64 Options outstanding at year end 9,475,890 3.43 7,681,256 3.03 7,566,438 2.74 Options exercisable at year end 5,808,528 3.27 4,452,274 3.17 3,304,981 3.09 Weighted average per share fair value of options granted during the year $ 3.58 $ 4.43 $ 2.14 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, 2015 : Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 9,475,890 $ 3.43 6.96 years $ 2,565 Exercisable 5,808,528 3.27 5.87 years 2,186 Outstanding, vested and expected to vest 9,016,217 3.41 6.86 years 2,541 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 Securities and Exchange Commission’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, 2015 2014 2013 Risk-free interest rate 1.55 % 1.79 % 1.73 % Volatility factor 96.80 % 102.54 % 100.76 % Grant date fair value of common stock options $ 3.58 $ 4.43 $ 2.14 Weighted-average expected life 6.03 years 5.89 years 5.92 years Assumed forfeiture rate 10.00 % 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, 2015 2014 2013 (In thousands) Sales and marketing $ 925 $ 548 $ 366 Research, development and medical affairs 1,271 981 504 General and administrative 2,732 2,274 1,586 Total employee stock-based compensation expense $ 4,928 $ 3,803 $ 2,456 As of December 31, 2015, there was approximately $10,325,000 of total unrecognized compensation cost related to outstanding stock option awards that will be recognized over a weighted average period of 2.8 years. The total fair value of shares vested during the year ended December 31, 2015 was approximately $4,824,000 . The total estimated fair value of options granted during the years ended December 31, 2015 , 2014 and 2013 was $9,172,000 , $3,177,000 and $5,618,000 , respectively. The total estimated intrinsic value of options exercised during the years ended December 31, 2015 , 2014 and 2013 was $568,000 , $1,710,000 and $79,000 , respectively. As of December 31, 2015, the Company was authorized to grant options to purchase up to an additional 381,880 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 our 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, 2016, an additional 1,800,233 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. The following table summarizes outstanding and exercisable options at December 31, 2015 : Options Outstanding Options Exercisable Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life Number Exercisable Weighted Average Remaining Contractual Life $1.33 - $1.99 3,126,509 5.59 2,666,467 5.36 $2.00 - $2.99 2,875,955 7.44 1,381,561 6.01 $3.00 - $4.99 609,667 6.47 422,781 5.16 $5.00 - $5.99 2,329,197 8.78 817,324 8.28 $6.00 - $10.99 181,412 5.42 167,245 5.13 $11.00 - $11.91 353,150 4.79 353,150 4.79 9,475,890 5,808,528 |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2015 | |
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. Total warrants to purchase common stock issued and exercisable were 738,331 and 362,970 at December 31, 2015 and 2014 , respectively. At December 31, 2015, the exercise prices ranged from $2.65 to $11.00 per share. The warrants are exercisable for a period between 5 and 10 years from the issuance date. Warrants to purchase 39,773 of the Company’s common stock were granted to the Lenders during the year ended December 31, 2010 in connection the issuance of the 2010 Term Loan (Note 9). The Lenders also held warrants to purchase an aggregate of up to 69,999 shares of the Company’s common stock, which were exercisable only upon the drawdown of the additional $11,000,000 subject to FDA approval of the NDA for ILUVIEN by December 31, 2011, which was not obtained. In May 2013, in connection with the 2013 Loan Agreement, the Company re-priced warrants to purchase an aggregate of up to 31,818 shares of the Company ’ s common stock previously issued to SVB in connection with the 2010 Term Loan; 15,909 of which were previously exercisable only upon the drawdown of the additional $11,000,000 of the 2010 Term Loan subject to FDA approval of the NDA for ILUVIEN by December 31, 2011. Upon re-pricing, each of the warrants was exercisable immediately at a per-share exercise price of $2.86 and had a remaining term of 7.4 years. SVB exercised 31,818 of their warrants in the first quarter of 2014 in which the Company issued 18,092 shares of common stock as part of a cashless exercise. In connection with Limited entering into the 2014 Loan Agreement (Note 9), the Company entered into a warrant agreement with Hercules 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. Further, in November 2015, the Company agreed to amend the warrant agreement in connection with the 2015 Loan Amendment to increase the number of shares issuable upon exercise to 660,377 and decrease the exercise price to $2.65 per share. |
Concentrations and Credit Risk
Concentrations and Credit Risk | 12 Months Ended |
Dec. 31, 2015 | |
Risks and Uncertainties [Abstract] | |
CONCENTRATIONS AND CREDIT RISK | CONCENTRATIONS AND CREDIT RISK There were two customers within the U.S. segment that accounted for approximately 68% of the Company ’ s total consolidated revenues for the year ended December 31, 2015 as a result of our sales to large pharmaceutical distributors in the U.S. These same customers accounted for approximately 88% of the Company ’ s consolidated accounts receivable at December 31, 2015. There were no customers that accounted for more than 10% of revenue for the year ended December 31, 2014 or accounts receivable at December 31, 2014. There were two pharmacy customers in the International segment that comprised $314,000 of the Company’s accounts receivable at December 31, 2013. These same two customers accounted for approximately 23% of the Company ’ s total consolidated revenues for the year ended December 31, 2013. For the year ended December 31, 2015, there were no vendors that comprised more than 10% of the Company ’ s total purchases. For the years ended December 31, 2014 and 2013, one vendor comprised of approximately 14% and two vendors comprised approximately 42% of the Company’s total purchases, respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | INCOME TAXES The components of net loss before taxes are as follows: Years Ended December 31, 2015 2014 2013 (In thousands) United States $ (6,026 ) $ (12,102 ) $ (29,303 ) Foreign (24,489 ) (23,634 ) (16,926 ) Loss before provision for income taxes $ (30,515 ) $ (35,736 ) $ (46,229 ) 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, 2015 2014 2013 (In thousands) Current expense (benefit): Federal $ — $ — $ — State — — — Foreign 353 174 — Current income tax expense 353 174 — Deferred expense (benefit): Federal 6,509 3,050 (18,565 ) State 819 355 (2,162 ) Foreign (223 ) (3,161 ) 3,160 7,105 244 (17,567 ) Valuation allowance (7,328 ) (244 ) 17,567 Deferred income tax expense (benefit) (223 ) — — Total income tax expense $ 130 $ 174 $ — The following summarizes activity related to the Company ’ s valuation allowance: Years Ended December 31, 2015 2014 2013 (In thousands) Valuation allowance at beginning of period $ (46,399 ) $ (46,155 ) $ (63,722 ) Income tax provision (7,328 ) (244 ) 17,567 Release of valuation allowance — — — Other — — — Valuation allowance at end of period $ (53,727 ) $ (46,399 ) $ (46,155 ) Worldwide net deferred tax assets and liabilities are as follows: December 31, 2015 2014 Deferred tax assets (In thousands) Depreciation and amortization $ 3 $ 8 Other deferred tax assets 4,643 3,305 NOL carry-forwards 36,941 32,191 Research and development costs 4,193 5,167 Collaboration agreement receivable reserves 8,186 5,749 Valuation allowance (53,727 ) (46,400 ) Total deferred tax assets $ 239 $ 20 Deferred tax liabilities Unrealized foreign currency gains $ (12 ) $ (20 ) Other deferred tax liabilities (4 ) — Total deferred tax liabilities (16 ) (20 ) Net deferred tax assets and deferred tax liabilities $ 223 $ — A reconciliation from the federal statutory rate to the total provision for income taxes is as follows: Years Ended December 31, 2015 2014 2013 Amount Percent Amount Percent Amount Percent Federal tax benefit at statutory rate $ (10,375 ) 34.0 % $ (12,150 ) 34.0 % $ (15,718 ) 34.0 % State tax — net of federal benefit (715 ) 2.4 (479 ) 1.3 (1,160 ) 2.5 Permanent items and other (3,997 ) 13.1 331 (0.9 ) 31,851 (68.9 ) Prior period transfer pricing adjustments — — 3,502 (9.8 ) — — Foreign rate differential 8,352 (27.4 ) 8,190 (22.9 ) 2,594 (5.6 ) Other (463 ) 1.5 536 (1.5 ) — — Change in valuation allowance 7,328 (24.0 ) 244 (0.7 ) (17,567 ) 38.0 Total tax expense (benefit) $ 130 (0.4 )% $ 174 (0.5 )% $ — — % The significant increase for the prior year in the effect of permanent differences is caused by intercompany transactions between Alimera Sciences, Inc. and its subsidiaries in the prior year. For financial statement purposes, the transaction eliminates in consolidation. For income tax purposes, the transaction resulted in taxable income in the United States which was offset by net operating losses. Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company believes that its income tax filing positions and deductions are more likely than not of being sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position; therefore, no ASC 740-10 liabilities and no related penalties and interest have been recorded. The Company does not anticipate any material changes to its uncertain tax positions within the next 12 months. Tax years since from 2012 to 2015 remain subject to examination in Georgia, Tennessee, 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 2003. 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. At December 31, 2015 and 2014 , the Company had federal net operating loss (NOL) carry-forwards of approximately $100,844,000 and $89,547,000 and state NOL carry-forwards of approximately $84,301,000 , and $73,003,000 respectively, that 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 2035 and the state NOL carry-forwards will expire at various dates between 2020 and 2035. NOL carry-forwards may be subject to annual limitations under Internal Revenue Code Section 382 (or comparable provisions of state law) in the event that certain changes in ownership of the Company were to occur. The Company periodically evaluates its NOL carry-forwards and whether certain changes in ownership, including its Initial Public Offering (IPO), 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 Internal Revenue Code (IRC), Section 382 (or comparable provisions of state law). The issuance of the Series A Convertible Preferred Stock on October 2, 2012 constituted such a change in ownership. As a result of this change in ownership, the Company performed a formal analysis in connection with IRC Section 382 and determined that approximately $13,700,000 of its NOLs generated prior to the change in ownership could not be utilized in the future. As of December 31, 2015, the Company had cumulative book losses in foreign subsidiaries of $67,452,000 . 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. |
Fair Value
Fair Value | 12 Months Ended |
Dec. 31, 2015 | |
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 inputs are quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. An active market for the asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. The valuation under this approach does not entail a significant degree of judgment. Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include: quoted prices for similar assets or liabilities in active markets, inputs other than quoted prices that are observable for the asset or liability, (e.g., interest rates and yield curves observable at commonly quoted intervals or current market) and contractual prices for the underlying financial instrument, as well as other relevant economic measures. Level 3 inputs are unobservable inputs for the asset or liability. Unobservable inputs shall be used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at the measurement date. There have been no changes in the methodologies used at December 31, 2015 and 2014. The following fair value table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis: December 31, 2015 Level 1 Level 2 Level 3 Total (In thousands) Assets: Cash equivalents (1) $ 1,010 $ — $ — $ 1,010 Assets measured at fair value $ 1,010 $ — $ — $ 1,010 Liabilities: Derivative warrant liability (2) $ — $ 2,815 $ — $ 2,815 Liabilities measured at fair value $ — $ 2,815 $ — $ 2,815 December 31, 2014 Level 1 Level 2 Level 3 Total (In thousands) Assets: Cash equivalents (1) $ 65,509 $ — $ — $ 65,509 Assets measured at fair value $ 65,509 $ — $ — $ 65,509 Liabilities: Derivative warrant liability (2) $ — $ 16,098 $ — $ 16,098 Liabilities measured at fair value $ — $ 16,098 $ — $ 16,098 (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, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
EMPLOYEE BENEFIT PLANS | EMPLOYEE BENEFIT PLANS The Company has a salary deferral 401(k) plan which 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 $268,000 , $107,000 and $95,000 for the years ended December 31, 2015 , 2014 and 2013 , respectively. The Company may also make an annual discretionary profit-sharing contribution. No such discretionary contributions were made during the years ended December 31, 2015 , 2014 and 2013 , 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, starting in 2011, the number of available shares will automatically be restored to the original level. A total of 72,261 , 34,915 and 26,123 shares of the Company’s common shares were acquired through the Purchase Plan during the years ended December 31, 2015 , 2014 , and 2013 , respectively. As such, on January 1, 2016 and 2015, respectively, an additional 72,261 and 34,915 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 $109,000 , $47,000 and $21,000 of compensation expense for the years ended December 31, 2015 , 2014 , and 2013 , respectively. |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting [Abstract] | |
Segment Information | SEGMENT INFORMATION The following table presents a summary of the Company ’ s reporting segments for the years ended December 31, 2015, 2014 and 2013: Year Ended U.S. International Consolidated (In thousands) NET REVENUE $ 15,170 $ 7,268 $ 22,438 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (792 ) (970 ) (1,762 ) GROSS PROFIT 14,378 6,298 20,676 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 9,712 5,128 14,840 GENERAL AND ADMINISTRATIVE EXPENSES 8,244 5,946 14,190 SALES AND MARKETING EXPENSES 19,777 8,313 28,090 DEPRECIATION AND AMORTIZATION 2,491 64 2,555 OPERATING EXPENSES 40,224 19,451 59,675 NET LOSS FROM OPERATIONS (25,846 ) (13,153 ) (38,999 ) OTHER INCOME AND EXPENSES, NET 8,484 NET LOSS BEFORE TAXES $ (30,515 ) Year Ended U.S. International Consolidated (In thousands) NET REVENUE $ 17 $ 8,406 $ 8,423 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1 ) (1,441 ) (1,442 ) GROSS PROFIT 16 6,965 6,981 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 5,400 6,411 11,811 GENERAL AND ADMINISTRATIVE EXPENSES 7,496 4,875 12,371 SALES AND MARKETING EXPENSES 4,704 10,383 15,087 DEPRECIATION AND AMORTIZATION 657 2 659 OPERATING EXPENSES 18,257 21,671 39,928 NET LOSS FROM OPERATIONS (18,241 ) (14,706 ) (32,947 ) OTHER INCOME AND EXPENSES, NET (2,789 ) NET LOSS BEFORE TAXES $ (35,736 ) Year Ended U.S. International Consolidated (In thousands) NET REVENUE $ — $ 1,872 $ 1,872 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION — (1,863 ) (1,863 ) GROSS PROFIT — 9 9 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 4,110 4,748 8,858 GENERAL AND ADMINISTRATIVE EXPENSES 5,048 4,427 9,475 SALES AND MARKETING EXPENSES 891 15,051 15,942 DEPRECIATION AND AMORTIZATION 138 — 138 OPERATING EXPENSES 10,187 24,226 34,413 NET LOSS FROM OPERATIONS (10,187 ) (24,217 ) (34,404 ) OTHER INCOME AND EXPENSES, NET (11,825 ) NET LOSS BEFORE TAXES $ (46,229 ) |
Selected Quarterly Financial Da
Selected Quarterly Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Financial Data (Unaudited) | SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) Selected quarterly financial data for years ended December 31, 2015 and 2014 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) 2015 NET REVENUE $ 3,938 $ 5,776 $ 6,901 $ 5,823 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (283 ) (376 ) (634 ) (469 ) GROSS PROFIT 3,655 5,400 6,267 5,354 LOSS FROM OPERATIONS (10,994 ) (9,800 ) (8,444 ) (9,761 ) NET LOSS (9,793 ) (8,596 ) (1,543 ) (10,713 ) NET LOSS APPLICABLE TO COMMON STOCKHOLDERS (9,793 ) (8,596 ) (1,543 ) (10,713 ) NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic and diluted (0.22 ) (0.19 ) (0.03 ) (0.24 ) 2014 NET REVENUE $ 2,084 $ 2,190 $ 2,408 $ 1,741 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (564 ) (376 ) (372 ) (130 ) GROSS PROFIT 1,520 1,814 2,036 1,611 LOSS FROM OPERATIONS (7,444 ) (5,958 ) (8,625 ) (10,920 ) NET LOSS (20,759 ) 1,116 (7,009 ) (9,258 ) NET LOSS APPLICABLE TO COMMON STOCKHOLDERS (20,759 ) 1,116 (7,009 ) (10,008 ) NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic (0.58 ) 0.03 (0.17 ) (0.23 ) NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Diluted (0.58 ) (0.16 ) (0.17 ) (0.23 ) |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Event | SUBSEQUENT EVENT As disclosed in Note 9, the Company entered into the second amendment to its Term Loan Agreement with Hercules in March 2016. The specific terms of the amendment are disclosed in detail within Note 9. |
Summary of Significant Accoun28
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
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. |
Reclassifications | Reclassifications — Within the operating expenses section of the Consolidated Statements of Operations for the year ended December 31, 2013, the Company reclassified depreciation expense of $138,000 from general and administrative expenses to depreciation and amortization to conform to the current year presentation. |
Cash and Cash Equivalents | Cash, Cash Equivalents and Restricted Cash — Cash and cash equivalents include cash and 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. The Company limits its exposure to credit loss by placing its cash and cash equivalents in highly liquid investments with high quality financial institutions. |
Revenue Recognition | Revenue Recognition — 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 shipment or upon receipt by the customer depending on the agreement with 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 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 from U.S. product sales is recorded upon sale to the pharmaceutical distributors net of applicable provisions for rebates and chargebacks under governmental programs, distribution-related fees and other sales-related 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. The Company estimates reductions to product sales for Medicaid and Veterans’ Administration (VA) programs and for certain other qualifying federal and state government programs. Based upon the Company’s contracts with government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience and estimated payer mix, the Company estimates and records an allowance for rebates and chargebacks. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make for a current quarter, claims for prior quarters that have been estimated for which an invoice has not been received and invoices received for claims from prior quarters that have not been paid. The Company’s reserves related to discounted pricing to VA, Public Health Services and other institutions (collectively qualified healthcare providers) represent the Company’s estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices the Company charges to its customers (i.e., pharmaceutical distributors). The Company’s customers charge the Company for the difference between what they pay for the products and the ultimate selling price to the qualified healthcare providers. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the historical chargebacks that customers have already claimed. The Company has written contracts with its customers that include terms for distribution-related fees. The Company estimates and records distribution and related fees due to its customers based on gross sales. Consistent with industry practice, the Company offers its customers a limited right to return product purchased directly from the Company, which is principally based upon the product’s expiration date. The Company will accept returns for three months prior to and up to nine months after the product expiration date. Depending on the circumstances, the Company may provide replacement products or cash credit for returns. Product returned is generally not resalable given the nature of the Company’s products and method of administration. The Company develops estimates for product returns based upon historical experience, inventory levels, shelf life of the product and other relevant factors. The Company monitors product supply levels in the distribution channel, as well as sales by its customers to healthcare providers using product-specific data provided by its customers. If necessary, the Company’s estimates of product returns may be adjusted in the future based on actual returns experience, known or expected changes in the marketplace, or other factors. |
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 which began in 2013. 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. |
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. If the actual net realizable value is less than that estimated, or if there are any further determinations that inventory will not be marketable based on estimates of demand, additional inventory write-downs will be required. |
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 estimated useful life of the intangible asset is approximately thirteen years . |
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 and fixtures and manufacturing equipment, five years ; automobiles, four years ; office equipment and leasehold improvements, 29 months to five years ; and software, three years . |
Impairment | Impairment — Property and equipment and 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 — In accordance with the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 740, Income Taxes , the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position; therefore, no ASC 740-10 liabilities have been recorded. The Company will recognize accrued interest and penalties related to unrecognized tax benefits, if any, as interest expense and income tax expense, respectively, in the consolidated statements of operations. 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 as a result of the Company ’ s history of operating losses, a valuation allowance has been established against the net deferred tax asset balance in the U.S. 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. |
Research and Development Costs | Research and Development Costs — Research and development costs are expensed as incurred. |
Stock-Based Compensation | Stock-Based Compensation — The Company has stock option plans which provide for grants of stock options to employees and directors to purchase shares of the Company’s common stock at exercise prices generally equal to the fair market values of such stock at the dates of grant. Compensation cost is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of 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, are 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. At December 31, 2015 and 2014, these warrants represented the only outstanding derivative instruments issued or held by the Company. |
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 | Translation Policy - The U.S. dollar is the functional currency for Alimera Sciences, Inc. The Euro is the functional currency for the majority of the Company ’ s subsidiaries operating outside of the U.S. For Alimera Sciences, Inc., foreign currency assets and liabilities are remeasured into U.S. dollars at end-of-period exchange rates, except for non-monetary balance sheet accounts, which are remeasured at historical exchange rates. Revenue and expenses are remeasured at average exchange rates in effect during each period, except for those expenses related to the non-monetary balance sheet amounts, which are remeasured at historical exchange rates. Gains or losses from foreign currency remeasurements are included in the statement of operations. The financial statements of the foreign subsidiaries whose functional currency is not the U.S. dollar, have been translated into U.S. dollars in accordance with ASC 830-30, Translation of Financial Statements . For the subsidiaries operating outside of the U.S. that are denominated in the Euro, assets and liabilities are translated at end-of-period rates while revenues and expenses are translated at average rates in effect during the period in which the activity took place. Equity is translated at historical rates and the resulting cumulative translation adjustments are included as a component of accumulated other comprehensive loss. |
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. |
Reporting Segments | Reporting Segments — The Company determines operating 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 upon net loss from operations. 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 two reportable segments, U.S. and International. |
Promotional and Advertising Costs | Promotional and Advertising Costs — Promotional and advertising costs are expensed as incurred. |
Adoption of New Accounting Pronouncements | Adoption of New Accounting Standards — In April 2015, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs . ASU 2015-03 is intended to simplify the presentation of debt issuance costs. These amendments require that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. The recognition and measurement guidance for debt issuance costs are not affected by the amendments in this ASU. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2015. Early adoption is permitted and the standard is to be retrospectively applied to all periods presented upon adoption. The Company elected to early adopt ASU 2015-03 effective December 31, 2015, and as a result reclassified $629,000 and $754,000 from deferred financing costs to note payable, net of discount in its Consolidated Balance Sheet as of December 31, 2015 and 2014, respectively. In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes , which simplifies the presentation of deferred income taxes. This ASU requires that deferred tax assets and liabilities be classified as non-current in a statement of financial position. The Company elected to early adopt ASU 2015-17 effective December 31, 2015 on a prospective basis. Adoption of this ASU resulted in a reclassification of our net current deferred tax asset to the net non-current deferred tax asset in its Consolidated Balance Sheet as of December 31, 2015. No prior periods were retrospectively adjusted. Accounting Standards Issued But Not Yet Effective — In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) . ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard will be effective for the first interim period within annual reporting periods beginning after December 15, 2017 for public entities, with early adoption permitted in the annual reporting period beginning after December 15, 2016. The Company is still evaluating the potential impact of adopting this guidance on its financial statements. In June 2014, the FASB issued ASU 2014-12, Compensation Stock - Compensation (Topic 718) . ASU 2014-12 applies to all reporting entities that grant their employees share-based payments in which the terms of the award provide that a performance target that affects vesting could be achieved after the requisite service period. It requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition and follows existing accounting guidance for the treatment of performance conditions. The standard will be effective for annual periods and interim periods within those annual periods beginning after December 15, 2015, with early adoption permitted. The Company does not expect there to be a material impact upon adopting this guidance on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern and to provide related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted. The Company does not expect there to be a material impact upon adopting this guidance on its financial statements. |
Summary of Significant Accoun29
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Schedule of Allowances fro Doubtful Accounts | The following summarizes activity related to the Company ’ s allowance for doubtful accounts: Years Ended December 31, 2015 2014 2013 (in thousands) Beginning balance $ — $ — $ — Bad debt expense 118 21 — Write-offs — (21 ) — Ending balance $ 118 $ — $ — |
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, 2015 2014 2013 Series A convertible preferred stock 9,022,556 9,022,556 15,037,594 Series B convertible preferred stock 8,416,251 8,416,251 — Series A convertible preferred stock warrants 4,511,279 4,511,279 4,511,279 Common stock warrants 738,331 362,970 109,772 Stock options 9,475,890 7,681,256 7,566,437 Total 32,164,307 29,994,312 27,225,082 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: December 31, 2015 2014 (In thousands) Component parts (1) $ 131 $ 76 Work-in-process (2) 333 219 Finished goods 1,525 1,972 Total inventory 1,989 2,267 Inventory reserve (437 ) (533 ) Inventory — net $ 1,552 $ 1,734 (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, 2015 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: December 31, 2015 2014 (In thousands) Furniture and fixtures $ 376 $ 367 Office equipment 794 652 Automobiles 1,028 — Software 902 601 Leasehold improvements 439 417 Manufacturing equipment 970 974 Total property and equipment 4,509 3,011 Less accumulated depreciation and amortization (1,956 ) (1,358 ) Property and equipment — net $ 2,553 $ 1,653 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Intangible Assets Future Amortization Expense | The estimated remaining amortization as of December 31, 2015 is as follows (in thousands): Years Ending December 31 2016 $ 1,940 2017 1,940 2018 1,940 2019 1,940 2020 1,940 Thereafter 12,849 Total $ 22,549 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2015 2014 (In thousands) Accrued clinical investigator expenses $ 732 $ 309 Accrued other compensation expenses 804 226 Accrued rebate, chargeback and other revenue reserves 452 — Accrued End of Term Payment (Note 9) 1,050 — Other accrued expenses 556 419 Total accrued expenses $ 3,594 $ 954 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Principal Payments Under Note Payable | As of December 31, 2015 a schedule of future minimum principal payments under the Note Payable is as follows (in thousands): Years Ending December 31 (In thousands) 2016 $ 35,000 Total $ 35,000 |
Schedule of Future Minimum Rental Payments for Operating Leases | At December 31, 2015 , a schedule by year of future minimum payments under operating leases is as follows: Years Ending December 31 (In thousands) 2016 $ 557 2017 567 2018 547 2019 527 2020 350 Thereafter 268 Total $ 2,816 |
Schedule by Year of Future Minimum Payments under Capital Leases, Together with Present Value of Minimum Lease Payments | At December 31, 2015 , 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) 2016 $ 396 2017 391 2018 380 2019 117 Total 1,284 Less amount representing interest (96 ) Less amount representing executory costs (372 ) Present value of minimum lease payments 816 Less current portion (234 ) Non-current portion $ 582 |
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, 2015 2014 (In thousands) Automobiles $ 1,028 $ — Office equipment 63 33 Less accumulated depreciation (212 ) (16 ) Total $ 879 $ 17 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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, 2015 2014 2013 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 7,681,256 $ 3.03 7,566,438 $ 2.74 5,493,079 $ 2.67 Grants 2,570,000 4.62 716,500 5.56 2,630,000 2.71 Forfeitures (431,114 ) 4.79 (210,375 ) 3.10 (513,059 ) 1.96 Exercises (344,252 ) 1.66 (391,307 ) 1.97 (43,582 ) 1.64 Options outstanding at year end 9,475,890 3.43 7,681,256 3.03 7,566,438 2.74 Options exercisable at year end 5,808,528 3.27 4,452,274 3.17 3,304,981 3.09 Weighted average per share fair value of options granted during the year $ 3.58 $ 4.43 $ 2.14 |
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, 2015 : Shares Weighted Average Exercise Price Weighted Average Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 9,475,890 $ 3.43 6.96 years $ 2,565 Exercisable 5,808,528 3.27 5.87 years 2,186 Outstanding, vested and expected to vest 9,016,217 3.41 6.86 years 2,541 |
Weighted-Average Assumptions Used for Option Grants | The weighted-average assumptions used for option grants were as follows: Years Ended December 31, 2015 2014 2013 Risk-free interest rate 1.55 % 1.79 % 1.73 % Volatility factor 96.80 % 102.54 % 100.76 % Grant date fair value of common stock options $ 3.58 $ 4.43 $ 2.14 Weighted-average expected life 6.03 years 5.89 years 5.92 years Assumed forfeiture rate 10.00 % 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, 2015 2014 2013 (In thousands) Sales and marketing $ 925 $ 548 $ 366 Research, development and medical affairs 1,271 981 504 General and administrative 2,732 2,274 1,586 Total employee stock-based compensation expense $ 4,928 $ 3,803 $ 2,456 |
Outstanding and Exercisable Options | The following table summarizes outstanding and exercisable options at December 31, 2015 : Options Outstanding Options Exercisable Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life Number Exercisable Weighted Average Remaining Contractual Life $1.33 - $1.99 3,126,509 5.59 2,666,467 5.36 $2.00 - $2.99 2,875,955 7.44 1,381,561 6.01 $3.00 - $4.99 609,667 6.47 422,781 5.16 $5.00 - $5.99 2,329,197 8.78 817,324 8.28 $6.00 - $10.99 181,412 5.42 167,245 5.13 $11.00 - $11.91 353,150 4.79 353,150 4.79 9,475,890 5,808,528 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Components of Net Loss before Taxes | The components of net loss before taxes are as follows: Years Ended December 31, 2015 2014 2013 (In thousands) United States $ (6,026 ) $ (12,102 ) $ (29,303 ) Foreign (24,489 ) (23,634 ) (16,926 ) Loss before provision for income taxes $ (30,515 ) $ (35,736 ) $ (46,229 ) |
Components of Income Tax Benefit | The provision for income taxes consists of the following components: Years Ended December 31, 2015 2014 2013 (In thousands) Current expense (benefit): Federal $ — $ — $ — State — — — Foreign 353 174 — Current income tax expense 353 174 — Deferred expense (benefit): Federal 6,509 3,050 (18,565 ) State 819 355 (2,162 ) Foreign (223 ) (3,161 ) 3,160 7,105 244 (17,567 ) Valuation allowance (7,328 ) (244 ) 17,567 Deferred income tax expense (benefit) (223 ) — — Total income tax expense $ 130 $ 174 $ — |
Summary of Valuation Allowance | The following summarizes activity related to the Company ’ s valuation allowance: Years Ended December 31, 2015 2014 2013 (In thousands) Valuation allowance at beginning of period $ (46,399 ) $ (46,155 ) $ (63,722 ) Income tax provision (7,328 ) (244 ) 17,567 Release of valuation allowance — — — Other — — — Valuation allowance at end of period $ (53,727 ) $ (46,399 ) $ (46,155 ) |
Net Deferred Tax Assets (Liabilities) | Worldwide net deferred tax assets and liabilities are as follows: December 31, 2015 2014 Deferred tax assets (In thousands) Depreciation and amortization $ 3 $ 8 Other deferred tax assets 4,643 3,305 NOL carry-forwards 36,941 32,191 Research and development costs 4,193 5,167 Collaboration agreement receivable reserves 8,186 5,749 Valuation allowance (53,727 ) (46,400 ) Total deferred tax assets $ 239 $ 20 Deferred tax liabilities Unrealized foreign currency gains $ (12 ) $ (20 ) Other deferred tax liabilities (4 ) — Total deferred tax liabilities (16 ) (20 ) Net deferred tax assets and deferred tax liabilities $ 223 $ — |
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, 2015 2014 2013 Amount Percent Amount Percent Amount Percent Federal tax benefit at statutory rate $ (10,375 ) 34.0 % $ (12,150 ) 34.0 % $ (15,718 ) 34.0 % State tax — net of federal benefit (715 ) 2.4 (479 ) 1.3 (1,160 ) 2.5 Permanent items and other (3,997 ) 13.1 331 (0.9 ) 31,851 (68.9 ) Prior period transfer pricing adjustments — — 3,502 (9.8 ) — — Foreign rate differential 8,352 (27.4 ) 8,190 (22.9 ) 2,594 (5.6 ) Other (463 ) 1.5 536 (1.5 ) — — Change in valuation allowance 7,328 (24.0 ) 244 (0.7 ) (17,567 ) 38.0 Total tax expense (benefit) $ 130 (0.4 )% $ 174 (0.5 )% $ — — % |
Fair Value (Tables)
Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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, 2015 Level 1 Level 2 Level 3 Total (In thousands) Assets: Cash equivalents (1) $ 1,010 $ — $ — $ 1,010 Assets measured at fair value $ 1,010 $ — $ — $ 1,010 Liabilities: Derivative warrant liability (2) $ — $ 2,815 $ — $ 2,815 Liabilities measured at fair value $ — $ 2,815 $ — $ 2,815 December 31, 2014 Level 1 Level 2 Level 3 Total (In thousands) Assets: Cash equivalents (1) $ 65,509 $ — $ — $ 65,509 Assets measured at fair value $ 65,509 $ — $ — $ 65,509 Liabilities: Derivative warrant liability (2) $ — $ 16,098 $ — $ 16,098 Liabilities measured at fair value $ — $ 16,098 $ — $ 16,098 (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, 2015 | |
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, 2015, 2014 and 2013: Year Ended U.S. International Consolidated (In thousands) NET REVENUE $ 15,170 $ 7,268 $ 22,438 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (792 ) (970 ) (1,762 ) GROSS PROFIT 14,378 6,298 20,676 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 9,712 5,128 14,840 GENERAL AND ADMINISTRATIVE EXPENSES 8,244 5,946 14,190 SALES AND MARKETING EXPENSES 19,777 8,313 28,090 DEPRECIATION AND AMORTIZATION 2,491 64 2,555 OPERATING EXPENSES 40,224 19,451 59,675 NET LOSS FROM OPERATIONS (25,846 ) (13,153 ) (38,999 ) OTHER INCOME AND EXPENSES, NET 8,484 NET LOSS BEFORE TAXES $ (30,515 ) Year Ended U.S. International Consolidated (In thousands) NET REVENUE $ 17 $ 8,406 $ 8,423 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (1 ) (1,441 ) (1,442 ) GROSS PROFIT 16 6,965 6,981 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 5,400 6,411 11,811 GENERAL AND ADMINISTRATIVE EXPENSES 7,496 4,875 12,371 SALES AND MARKETING EXPENSES 4,704 10,383 15,087 DEPRECIATION AND AMORTIZATION 657 2 659 OPERATING EXPENSES 18,257 21,671 39,928 NET LOSS FROM OPERATIONS (18,241 ) (14,706 ) (32,947 ) OTHER INCOME AND EXPENSES, NET (2,789 ) NET LOSS BEFORE TAXES $ (35,736 ) Year Ended U.S. International Consolidated (In thousands) NET REVENUE $ — $ 1,872 $ 1,872 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION — (1,863 ) (1,863 ) GROSS PROFIT — 9 9 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 4,110 4,748 8,858 GENERAL AND ADMINISTRATIVE EXPENSES 5,048 4,427 9,475 SALES AND MARKETING EXPENSES 891 15,051 15,942 DEPRECIATION AND AMORTIZATION 138 — 138 OPERATING EXPENSES 10,187 24,226 34,413 NET LOSS FROM OPERATIONS (10,187 ) (24,217 ) (34,404 ) OTHER INCOME AND EXPENSES, NET (11,825 ) NET LOSS BEFORE TAXES $ (46,229 ) |
Selected Quarterly Financial 39
Selected Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | Selected quarterly financial data for years ended December 31, 2015 and 2014 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) 2015 NET REVENUE $ 3,938 $ 5,776 $ 6,901 $ 5,823 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (283 ) (376 ) (634 ) (469 ) GROSS PROFIT 3,655 5,400 6,267 5,354 LOSS FROM OPERATIONS (10,994 ) (9,800 ) (8,444 ) (9,761 ) NET LOSS (9,793 ) (8,596 ) (1,543 ) (10,713 ) NET LOSS APPLICABLE TO COMMON STOCKHOLDERS (9,793 ) (8,596 ) (1,543 ) (10,713 ) NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic and diluted (0.22 ) (0.19 ) (0.03 ) (0.24 ) 2014 NET REVENUE $ 2,084 $ 2,190 $ 2,408 $ 1,741 COST OF GOOD SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (564 ) (376 ) (372 ) (130 ) GROSS PROFIT 1,520 1,814 2,036 1,611 LOSS FROM OPERATIONS (7,444 ) (5,958 ) (8,625 ) (10,920 ) NET LOSS (20,759 ) 1,116 (7,009 ) (9,258 ) NET LOSS APPLICABLE TO COMMON STOCKHOLDERS (20,759 ) 1,116 (7,009 ) (10,008 ) NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic (0.58 ) 0.03 (0.17 ) (0.23 ) NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Diluted (0.58 ) (0.16 ) (0.17 ) (0.23 ) |
Nature of Operations (Detail)
Nature of Operations (Detail) - ILUVIEN | 12 Months Ended |
Dec. 31, 2015Patient | |
Nature Of Operations [Line Items] | |
Post-authorization open study period | 5 years |
Number of patients involved in post-authorization open study period | 800 |
Summary of Significant Accoun41
Summary of Significant Accounting Policies - Prior Period Adjustments (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Depreciation | $ 614 | $ 149 | $ 138 |
Prior Period Adjustment | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Medical affairs support expense | 448 | 429 | |
Prior Period Adjustment | Depreciation and Amortization | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Depreciation | $ 138 | ||
Deferred financing costs | Effect of early adoption | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Debt issuance costs | (629) | (754) | |
Notes payable, net of discount | Effect of early adoption | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Debt issuance costs | $ 629 | $ 754 |
Summary of Significant Accoun42
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015USD ($)Segment | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2012USD ($) | |
Accounting Policies [Abstract] | ||||
Number of reportable segments | Segment | 2 | |||
Cash and cash equivalents | $ 31,075 | $ 76,697 | $ 12,628 | $ 49,564 |
Percentage of cash and cash equivalents in domestic financial institutions | 90.00% | 96.00% | ||
Useful life of intangible assets | 13 years | |||
Research and development expense | $ 2,745 | $ 7,594 | $ 3,904 |
Summary of Significant Accoun43
Summary of Significant Accounting Policies - Allowances for Doubtful Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Allowance for Doubtful Accounts Receivable [Roll Forward] | |||
Beginning balance | $ 0 | $ 0 | $ 0 |
Bad debt expense | 118 | 21 | 0 |
Write-offs | 0 | (21) | 0 |
Ending balance | $ 118 | $ 0 | $ 0 |
Summary of Significant Accoun44
Summary of Significant Accounting Policies - Long Lived Assets (Details) | 12 Months Ended |
Dec. 31, 2015 | |
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 |
Office equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 29 months |
Office equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Summary of Significant Accoun45
Summary of Significant Accounting Policies - Securities Not Included in Computation of Diluted EPS (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive securities (in shares) | 32,164,307 | 29,994,312 | 27,225,082 |
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 | 15,037,594 |
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 | 0 |
Series A convertible preferred stock warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive securities (in shares) | 4,511,279 | 4,511,279 | 4,511,279 |
Common stock warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive securities (in shares) | 738,331 | 362,970 | 109,772 |
Stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total potentially dilutive securities (in shares) | 9,475,890 | 7,681,256 | 7,566,437 |
Factors Affecting Operations (D
Factors Affecting Operations (Detail) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ (343,900,000) | $ (313,255,000) | ||
Cash and cash equivalents | 31,075,000 | $ 76,697,000 | $ 12,628,000 | $ 49,564,000 |
Maximum common stock to be issued in at-the-market offering | $ 34,175,000 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | |
Inventory net realizable value | |||
Component parts | [1] | $ 131 | $ 76 |
Work-in-process | [2] | 333 | 219 |
Finished goods | 1,525 | 1,972 | |
Inventory, Gross | 1,989 | 2,267 | |
Inventory reserve | (437) | (533) | |
Inventory — net | $ 1,552 | $ 1,734 | |
[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, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 4,509 | $ 3,011 | |
Less accumulated depreciation and amortization | (1,956) | (1,358) | |
Property and equipment — net | 2,553 | 1,653 | |
Depreciation expense | 614 | 149 | $ 138 |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 376 | 367 | |
Office equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 794 | 652 | |
Automobiles | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 1,028 | 0 | |
Software | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 902 | 601 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 439 | 417 | |
Manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 970 | $ 974 |
Intangible Assets - Activity (D
Intangible Assets - Activity (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Intangible assets, net | $ 22,549,000 | $ 0 | ||
Useful life | 13 years | |||
Licensing Agreement | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Intangible assets, net | $ 22,549,000 | $ 24,490,000 | ||
Intangible assets, gross | $ 25,000,000 | |||
Useful life | 13 years | |||
Intangible asset amortization expense | $ 1,941,000 | $ 510,000 | ||
pSivida | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Additional milestone payment after the first product approved by the FDA | $ 25,000,000 | $ 25,000,000 |
Intangible Assets - Future Amor
Intangible Assets - Future Amortization Expense (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2013 |
Finite-Lived Intangible Assets, Net, Amortization Expense, Fiscal Year Maturity [Abstract] | ||
2,016 | $ 1,940 | |
2,017 | 1,940 | |
2,018 | 1,940 | |
2,019 | 1,940 | |
2,020 | 1,940 | |
Thereafter | 12,849 | |
Total | $ 22,549 | $ 0 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Nov. 30, 2015 | Dec. 31, 2014 |
Summary of accrued expenses | |||
Accrued clinical investigator expenses | $ 732 | $ 309 | |
Accrued other compensation expenses | 804 | 226 | |
Accrued rebate, chargeback and other revenue reserves | 452 | 0 | |
Accrued End of Term Payment (Note 9) | 1,050 | $ 1,050 | 0 |
Other accrued expenses | 556 | 419 | |
Total accrued expenses | $ 3,594 | $ 954 |
License Agreements (Details)
License Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Share of net profits | 20.00% | ||
Share of any lump sum milestone payments received from a sub-licensee of ILUVIEN | 33.00% | ||
Recovery of commercialization costs | 20.00% | ||
Commercialization costs owned | $ 21,565,000 | $ 12,956,000 | |
pSivida | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
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 | ||
Additional milestone payment after the first product approved by the FDA | $ 25,000,000 | $ 25,000,000 |
Loan Agreements (Detail)
Loan Agreements (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||||
Nov. 30, 2015 | Sep. 30, 2014 | Apr. 30, 2014 | May. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2011 | Mar. 14, 2016 | Dec. 31, 2010 | |
Debt Instrument [Line Items] | ||||||||||
Loss on early extinguishment of debt | $ 0 | $ 440,000 | $ 153,000 | |||||||
Increase of term loan | $ 11,000,000 | |||||||||
Balloon payment to be paid | $ 1,050,000 | 1,050,000 | $ 0 | |||||||
Maximum common stock to be issued in at-the-market offering | $ 34,175,000 | |||||||||
Number of shares called by warrants | 31,818 | 39,773 | ||||||||
Exercise price on warrants (in dollars per share) | $ 2.86 | |||||||||
Alimera Sciences, Inc. | Hercules Technology Growth Capital | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Increase of term loan | $ 25,000,000 | |||||||||
Number of shares called by warrants | 660,377 | 285,016 | ||||||||
Exercise price on warrants (in dollars per share) | $ 2.65 | $ 6.14 | ||||||||
Percent of warrants exercisable upon closing | 60.00% | |||||||||
Percent of warrants exercisable upon satisfying certain conditions | 40.00% | |||||||||
Alimera Sciences, Inc. | 2014 Term Loan | Hercules Technology Growth Capital | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Increase of term loan | $ 25,000,000 | |||||||||
Number of shares called by warrants | 285,016 | |||||||||
Exercise price on warrants (in dollars per share) | $ 6.14 | |||||||||
Fair value of warrants | $ 1,349,000 | |||||||||
Discount | $ 1,250,000 | $ 1,277,000 | ||||||||
Percent of warrants exercisable upon closing | 60.00% | |||||||||
Percent of warrants exercisable upon satisfying certain conditions | 40.00% | |||||||||
Alimera Sciences, Inc. | 2015 Loan Amendment | Hercules Technology Growth Capital | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Number of shares called by warrants | 660,377 | |||||||||
Exercise price on warrants (in dollars per share) | $ 2.65 | |||||||||
Alimera Sciences Limited | 2010 Term Loan | Silicon Valley Bank (SVB) | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Loss on early extinguishment of debt | $ 153,000 | |||||||||
Alimera Sciences Limited | 2013 Term Loan | Silicon Valley Bank (SVB) | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan amount | 5,000,000 | |||||||||
Loss on early extinguishment of debt | $ 440,000 | |||||||||
Prepayment fee | 133,000 | |||||||||
Alimera Sciences Limited | 2013 Line of Credit | Silicon Valley Bank (SVB) | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Company entitled to borrow | $ 15,000,000 | |||||||||
Termination fee amount | 113,000 | |||||||||
Alimera Sciences Limited | 2014 Term Loan | Hercules Technology Growth Capital | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Term loan amount | 10,000,000 | |||||||||
Company entitled to borrow | $ 35,000,000 | |||||||||
Increase of term loan | $ 25,000,000 | |||||||||
Interest rate on term loan (percent) | 10.90% | |||||||||
Amortization period | 30 months | |||||||||
An upfront fee payment to Lenders | $ 262,500 | |||||||||
Debt issuance fees | $ 375,000 | $ 383,000 | ||||||||
Prepayment fee percentage within the first year of borrowing | 1.25% | |||||||||
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 | 2015 Loan Amendment | Hercules Technology Growth Capital | ||||||||||
Debt Instrument [Line Items] | ||||||||||
An upfront fee payment to Lenders | $ 262,500 | |||||||||
Balloon payment to be paid | $ 1,050,000 | |||||||||
Balloon payment, percent of principal | 3.00% | |||||||||
Minimum liquidity threshold per covenant | $ 20,000,000 | |||||||||
Minimum required cash balance per covenant | $ 10,000,000 | |||||||||
Subsequent event | Alimera Sciences Limited | 2016 Loan Amendment | Hercules Technology Growth Capital | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Balloon payment to be paid | $ 1,400,000 | |||||||||
Minimum liquidity threshold per covenant | 25,000,000 | |||||||||
Minimum required cash balance per covenant | 17,500,000 | |||||||||
Minimum required cash balance to waive revenue requirement | 25,000,000 | |||||||||
Amendment fee paid | $ 350,000 | |||||||||
Number of shares called by warrants | 862,069 | |||||||||
Exercise price on warrants (in dollars per share) | $ 2.03 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Future Minimum Principal Payments Under Note Payable (Detail) $ in Thousands | Dec. 31, 2015USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2,016 | $ 35,000 |
Total | $ 35,000 |
Commitments and Contingencies55
Commitments and Contingencies - Schedule of Operating Lease Assets (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Operating Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | |
2,016 | $ 557 |
2,017 | 567 |
2,018 | 547 |
2,019 | 527 |
2,020 | 350 |
Thereafter | 268 |
Total | $ 2,816 |
Commitments and Contingencies56
Commitments and Contingencies - Additional Information (Detail) | Jan. 01, 2016USD ($)Employee | May. 31, 2013Patientcontract | Feb. 28, 2010 | Dec. 31, 2015USD ($)PatientEmployee | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2015USD ($)agreement | Nov. 30, 2015USD ($) |
Commitments and Contingencies [Line Items] | ||||||||
Accrued and unpaid interest payable on Note Payable | $ 333,000 | $ 324,000 | $ 333,000 | |||||
Balloon payment to be paid | 1,050,000 | 0 | 1,050,000 | $ 1,050,000 | ||||
Rent expense under all operating leases | 541,000 | 521,000 | $ 576,000 | |||||
Depreciation expense | 614,000 | 149,000 | 138,000 | |||||
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 | |||||||
Outsourced services payable | $ 317,000 | 1,466,000 | 317,000 | |||||
Number of executives in employment agreements | Employee | 5 | |||||||
Subsequent event | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Number of executives in employment agreements | Employee | 5 | |||||||
Minimum | Subsequent event | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Executives salaries | $ 303,000 | |||||||
Maximum | Subsequent event | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Executives salaries | $ 519,000 | |||||||
CRO Agreement, physician utilization study | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Clinical and data management services expense | $ 591,000 | 346,000 | 222,000 | |||||
Clinical and data management services expense expected to be incurred | 810,000 | 810,000 | ||||||
Outsourced services payable | 150,000 | 0 | 150,000 | |||||
Quintiles Commercial Europe Limited | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Clinical and data management services expense | 1,030,000 | 5,800,000 | 7,500,000 | |||||
Prepaid clinical and data management services | 0 | 0 | ||||||
Outsourced services payable | 170,000 | $ 170,000 | ||||||
Capital leased assets | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Depreciation expense | $ 210,000 | $ 11,000 | $ 11,000 | |||||
ILUVIEN | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Post-authorization open study period | 5 years | |||||||
Number of patients involved in post-authorization open study period | Patient | 800 | |||||||
ILUVIEN | CRO Agreement, physician utilization study | ||||||||
Commitments and Contingencies [Line Items] | ||||||||
Number of contract research organizations engaged | contract | 2 | |||||||
Post-authorization open study period | 5 years | |||||||
Number of patients involved in post-authorization open study period | Patient | 800 | |||||||
Number of agreements for clinical and data management services | agreement | 8 |
Commitments and Contingencies57
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, 2015 | Dec. 31, 2014 |
Capital Leases, Future Minimum Payments Due, Fiscal Year Maturity [Abstract] | ||
2,016 | $ 396 | |
2,017 | 391 | |
2,018 | 380 | |
2,019 | 117 | |
Total | 1,284 | |
Less amount representing interest | (96) | |
Less amount representing executory costs | (372) | |
Present value of minimum lease payments | 816 | |
Less current portion | (234) | $ (11) |
Non-current portion | $ 582 | $ 8 |
Commitments and Contingencies58
Commitments and Contingencies - Property and Equipment Under Capital Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Capital Leased Assets [Line Items] | ||
Less accumulated depreciation | $ (212) | $ (16) |
Total | 879 | 17 |
Automobiles | ||
Capital Leased Assets [Line Items] | ||
Gross capital leased assets | 1,028 | 0 |
Office equipment | ||
Capital Leased Assets [Line Items] | ||
Gross capital leased assets | $ 63 | $ 33 |
Preferred Stock (Detail)
Preferred Stock (Detail) - USD ($) | Dec. 12, 2014 | Oct. 02, 2012 | Sep. 30, 2014 | Apr. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Class of Stock [Line Items] | |||||||
Estimated fair value of derivatives | $ 2,815,000 | $ 16,098,000 | |||||
Gain (loss) on change in fair value of derivatives | 13,283,000 | 283,000 | $ (11,964,000) | ||||
Issuance of preferred stock | 49,568,000 | ||||||
Stock issuance costs incurred | $ 27,000 | $ 2,389,000 | $ 0 | ||||
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) | 250,000 | 150,000 | |||||
Common Stock | |||||||
Class of Stock [Line Items] | |||||||
Shares issued in conversion of preferred stock (in shares) | 3,759,398 | 2,255,639 | |||||
Series B convertible preferred stock | |||||||
Class of Stock [Line Items] | |||||||
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 ($) $ in Thousands | Jan. 01, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2010 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Contractual term | 5 years 10 months 13 days | ||||
Total estimated fair value of options granted | $ 9,172 | $ 3,177 | $ 5,618 | ||
Total estimated intrinsic value of options exercised | $ 568 | $ 1,710 | $ 79 | ||
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 | $ 10,325 | ||||
Total unrecognized compensation cost related to outstanding stock option awards, recognition period (in years) | 2 years 9 months 7 days | ||||
Total fair value of shares vested during period | $ 4,824 | ||||
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 | 381,880 | ||||
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 | 1,800,233 | ||||
Directors Option Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Contractual term | 10 years |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Stock Option Transactions (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Options | |||
Options outstanding at beginning of period (in shares) | 7,681,256 | 7,566,438 | 5,493,079 |
Grants (in shares) | 2,570,000 | 716,500 | 2,630,000 |
Forfeitures (in shares) | (431,114) | (210,375) | (513,059) |
Exercises (in shares) | (344,252) | (391,307) | (43,582) |
Options outstanding at year end (in shares) | 9,475,890 | 7,681,256 | 7,566,438 |
Options exercisable at year end (in shares) | 5,808,528 | 4,452,274 | 3,304,981 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 3.58 | $ 4.43 | $ 2.14 |
Weighted Average Exercise Price | |||
Options outstanding at beginning of period (in dollars per share) | 3.03 | 2.74 | 2.67 |
Grants (in dollars per share) | 4.62 | 5.56 | 2.71 |
Forfeitures (in dollars per share) | 4.79 | 3.10 | 1.96 |
Exercises (in dollars per share) | 1.66 | 1.97 | 1.64 |
Options outstanding at year end (in dollars per share) | 3.43 | 3.03 | 2.74 |
Options exercisable at year end (in dollars per share) | $ 3.27 | $ 3.17 | $ 3.09 |
Stock Incentive Plans - Addit62
Stock Incentive Plans - Additional Stock Option Transactions (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||
Outstanding, Shares | 9,475,890 | 7,681,256 | 7,566,438 | 5,493,079 |
Exercisable, Shares | 5,808,528 | 4,452,274 | 3,304,981 | |
Outstanding, vested and expected to vest, Shares | 9,016,217 | |||
Outstanding, Weighted Average Exercise Price (in dollars per share) | $ 3.43 | $ 3.03 | $ 2.74 | $ 2.67 |
Exercisable, Weighted Average Exercise Price (in dollars per share) | 3.27 | $ 3.17 | $ 3.09 | |
Outstanding, vested and expected to vest, Weighted Average Exercise Price (in dollars per share) | $ 3.41 | |||
Outstanding, Weighted Average Contractual Term | 6 years 11 months 15 days | |||
Exercisable, Weighted Average Contractual Term | 5 years 10 months 13 days | |||
Outstanding, vested and expected to vest, Weighted Average Contractual Term | 6 years 10 months 9 days | |||
Outstanding, Aggregate Intrinsic Value | $ 2,565 | |||
Exercisable, Aggregate Intrinsic Value | 2,186 | |||
Outstanding, vested and expected to vest, Aggregate Intrinsic Value | $ 2,541 |
Stock Incentive Plans - Weighte
Stock Incentive Plans - Weighted-Average Assumptions Used for Option Grants (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Risk-free interest rate (percent) | 1.55% | 1.79% | 1.73% |
Volatility factor (percent) | 96.80% | 102.54% | 100.76% |
Grant date fair value of common stock options (in dollars per share) | $ 3.58 | $ 4.43 | $ 2.14 |
Weighted-average expected life | 6 years 10 days | 5 years 10 months 20 days | 5 years 11 months 1 day |
Assumed forfeiture rate (percent) | 10.00% | 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, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | $ 4,928 | $ 3,803 | $ 2,456 |
Sales and marketing | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | 925 | 548 | 366 |
Research, development and medical affairs | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | 1,271 | 981 | 504 |
General and administrative | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total employee stock-based compensation expense | $ 2,732 | $ 2,274 | $ 1,586 |
Stock Incentive Plans - Outstan
Stock Incentive Plans - Outstanding and Exercisable Options (Detail) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Options Outstanding, Number Outstanding (shares) | 9,475,890 |
Options Exercisable, Number Exercisable (shares) | 5,808,528 |
$1.33 - $1.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower limit (in dollars per share) | $ / shares | $ 1.33 |
Exercise price upper limit (in dollars per share) | $ / shares | $ 1.99 |
Options Outstanding, Number Outstanding (shares) | 3,126,509 |
Options Outstanding, Weighted Average Remaining Contractual Life | 5 years 7 months 2 days |
Options Exercisable, Number Exercisable (shares) | 2,666,467 |
Options Exercisable, Weighted Average Remaining Contractual Life | 5 years 4 months 9 days |
$2.00 - $2.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower limit (in dollars per share) | $ / shares | $ 2 |
Exercise price upper limit (in dollars per share) | $ / shares | $ 2.99 |
Options Outstanding, Number Outstanding (shares) | 2,875,955 |
Options Outstanding, Weighted Average Remaining Contractual Life | 7 years 5 months 8 days |
Options Exercisable, Number Exercisable (shares) | 1,381,561 |
Options Exercisable, Weighted Average Remaining Contractual Life | 6 years 3 days |
$3.00 - $4.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower limit (in dollars per share) | $ / shares | $ 3 |
Exercise price upper limit (in dollars per share) | $ / shares | $ 4.99 |
Options Outstanding, Number Outstanding (shares) | 609,667 |
Options Outstanding, Weighted Average Remaining Contractual Life | 6 years 5 months 19 days |
Options Exercisable, Number Exercisable (shares) | 422,781 |
Options Exercisable, Weighted Average Remaining Contractual Life | 5 years 1 month 27 days |
$5.00 - $5.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower limit (in dollars per share) | $ / shares | $ 5 |
Exercise price upper limit (in dollars per share) | $ / shares | $ 5.99 |
Options Outstanding, Number Outstanding (shares) | 2,329,197 |
Options Outstanding, Weighted Average Remaining Contractual Life | 8 years 9 months 10 days |
Options Exercisable, Number Exercisable (shares) | 817,324 |
Options Exercisable, Weighted Average Remaining Contractual Life | 8 years 3 months 10 days |
$6.00 - $10.99 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower limit (in dollars per share) | $ / shares | $ 6 |
Exercise price upper limit (in dollars per share) | $ / shares | $ 10.99 |
Options Outstanding, Number Outstanding (shares) | 181,412 |
Options Outstanding, Weighted Average Remaining Contractual Life | 5 years 5 months 1 day |
Options Exercisable, Number Exercisable (shares) | 167,245 |
Options Exercisable, Weighted Average Remaining Contractual Life | 5 years 1 month 17 days |
$11.00 - $11.91 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price lower limit (in dollars per share) | $ / shares | $ 11 |
Exercise price upper limit (in dollars per share) | $ / shares | $ 11.91 |
Options Outstanding, Number Outstanding (shares) | 353,150 |
Options Outstanding, Weighted Average Remaining Contractual Life | 4 years 9 months 14 days |
Options Exercisable, Number Exercisable (shares) | 353,150 |
Options Exercisable, Weighted Average Remaining Contractual Life | 4 years 9 months 14 days |
Common Stock Warrants (Detail)
Common Stock Warrants (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Apr. 30, 2014 | May. 31, 2013 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2011 | Nov. 30, 2015 | Dec. 31, 2014 | Dec. 31, 2010 | |
Class of Warrant or Right [Line Items] | ||||||||
Warrants to purchase common stock issued and outstanding (in shares) | 738,331 | 362,970 | ||||||
Warrants to purchase Company's common stock, granted during period (in shares) | 31,818 | 39,773 | ||||||
Warrants held by lender subject to becoming exercisable on company drawing debt (in shares) | 15,909 | 69,999 | ||||||
Increase of term loan | $ 11,000,000 | |||||||
Remaining term loan maximum availability | $ 11,000,000 | |||||||
Exercise price on warrants (in dollars per share) | $ 2.86 | |||||||
Number of shares called by warrants, remaining period | 7 years 4 months 24 days | |||||||
Minimum | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Warrants to purchase common, exercise prices (in dollars per share) | $ 2.65 | |||||||
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 | |||||||
Silicon Valley Bank (SVB) | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Number of warrants exercised (in shares) | 31,818 | |||||||
Conversion of warrants (shares issued) | 18,092 | |||||||
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 | 660,377 | ||||||
Increase of term loan | $ 25,000,000 | |||||||
Exercise price on warrants (in dollars per share) | $ 6.14 | $ 2.65 | ||||||
Percent of warrants exercisable upon closing | 60.00% | |||||||
Percent of warrants exercisable upon satisfying certain conditions | 40.00% |
Concentrations and Credit Risk
Concentrations and Credit Risk (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015USD ($)customer | Dec. 31, 2014USD ($)customer | Dec. 31, 2013USD ($)customer | |
Concentration Risk [Line Items] | |||
Accounts receivable, net | $ | $ 9,799 | $ 850 | |
Revenue | Customer concentration risk | |||
Concentration Risk [Line Items] | |||
Concentration risk, number of customers | 2 | 0 | 2 |
Concentration risk percentage | 68.00% | 23.00% | |
Accounts receivable | Customer concentration risk | |||
Concentration Risk [Line Items] | |||
Concentration risk, number of customers | 2 | 0 | 2 |
Accounts receivable, net | $ | $ 314 | ||
Concentration risk percentage | 88.00% | ||
Purchases | Supplier concentration risk | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 14.00% | 42.00% | |
Concentration risk, number of vendors | 0 | 1 | 2 |
Income Taxes - Components of Ne
Income Taxes - Components of Net Loss before Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Disclosure [Abstract] | |||
United States | $ (6,026) | $ (12,102) | $ (29,303) |
Foreign | (24,489) | (23,634) | (16,926) |
Loss before provision for income taxes | $ (30,515) | $ (35,736) | $ (46,229) |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Benefit (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current Income Tax Expense (Benefit), Continuing Operations [Abstract] | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 0 | 0 | 0 |
Foreign | 353 | 174 | 0 |
Current income tax expense | 353 | 174 | 0 |
Deferred benefit (expense): | |||
Federal | 6,509 | 3,050 | (18,565) |
State | 819 | 355 | (2,162) |
Foreign | (223) | (3,161) | 3,160 |
Deferred benefit (expense), gross | 7,105 | 244 | (17,567) |
Valuation allowance | (7,328) | (244) | 17,567 |
Deferred income tax expense (benefit) | (223) | 0 | 0 |
Total income tax expense | $ 130 | $ 174 | $ 0 |
Income Taxes - Valuation Allowa
Income Taxes - Valuation Allowance Rollforward (Details) - Deferred Tax Asset Valuation Allowance - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Beginning balance | $ (46,399) | $ (46,155) | $ (63,722) |
Income tax provision | (7,328) | (244) | 17,567 |
Release of valuation allowance | 0 | 0 | 0 |
Other | 0 | 0 | 0 |
Ending balance | $ (53,727) | $ (46,399) | $ (46,155) |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Liabilities) (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets | ||
Depreciation and amortization | $ 3 | $ 8 |
Other deferred tax assets | 4,643 | 3,305 |
NOL carry-forwards | 36,941 | 32,191 |
Research and development costs | 4,193 | 5,167 |
Collaboration agreement receivable reserves | 8,186 | 5,749 |
Valuation allowance | (53,727) | (46,400) |
Total deferred tax assets | 239 | 20 |
Deferred tax liabilities | ||
Unrealized foreign currency gains | (12) | (20) |
Other deferred tax liabilities | (4) | 0 |
Total deferred tax liabilities | (16) | (20) |
Net deferred tax assets and deferred tax liabilities | $ 223 | $ 0 |
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, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Amount | |||
Federal tax benefit at statutory rate | $ (10,375) | $ (12,150) | $ (15,718) |
State tax — net of federal benefit | (715) | (479) | (1,160) |
Permanent items and other | (3,997) | 331 | 31,851 |
Prior period transfer pricing adjustments | 0 | 3,502 | 0 |
Foreign rate differential | 8,352 | 8,190 | 2,594 |
Other | (463) | 536 | 0 |
Change in valuation allowance | 7,328 | 244 | (17,567) |
Total income tax expense | $ 130 | $ 174 | $ 0 |
Percent | |||
Federal tax benefit at statutory rate | 34.00% | 34.00% | 34.00% |
State tax — net of federal benefit | 2.40% | 1.30% | 2.50% |
Permanent items and other | 13.10% | (0.90%) | (68.90%) |
Prior period transfer pricing adjustments | 0.00% | (9.80%) | 0.00% |
Foreign rate differential | (27.40%) | (22.90%) | (5.60%) |
Other | 1.50% | (1.50%) | 0.00% |
Change in valuation allowance | (24.00%) | (0.70%) | 38.00% |
Total tax expense (benefit) | (0.40%) | (0.50%) | 0.00% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Operating Loss Carryforwards [Line Items] | ||
Amount of net operating loss that could not be utilized in the future due to changes in company ownership | $ (13,700) | |
Cumulative book losses in foreign subsidiaries | (67,452) | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | 100,844 | $ 89,547 |
State | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry-forwards | $ 84,301 | $ 73,003 |
Fair Value (Detail)
Fair Value (Detail) - Recurring basis - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | |
Assets: | |||
Cash equivalents | [1] | $ 1,010 | $ 65,509 |
Assets measured at fair value | 1,010 | 65,509 | |
Liabilities: | |||
Derivative warrant liability | [2] | 2,815 | 16,098 |
Liabilities measured at fair value | 2,815 | 16,098 | |
Level 1 | |||
Assets: | |||
Cash equivalents | [1] | 1,010 | 65,509 |
Assets measured at fair value | 1,010 | 65,509 | |
Liabilities: | |||
Derivative warrant liability | [2] | 0 | 0 |
Liabilities measured at fair value | 0 | 0 | |
Level 2 | |||
Assets: | |||
Cash equivalents | [1] | 0 | 0 |
Assets measured at fair value | 0 | 0 | |
Liabilities: | |||
Derivative warrant liability | [2] | 2,815 | 16,098 |
Liabilities measured at fair value | 2,815 | 16,098 | |
Level 3 | |||
Assets: | |||
Cash equivalents | [1] | 0 | 0 |
Assets measured at fair value | 0 | 0 | |
Liabilities: | |||
Derivative warrant liability | [2] | 0 | 0 |
Liabilities measured at fair value | $ 0 | $ 0 | |
[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 (Detail)
Employee Benefit Plans (Detail) | Jan. 01, 2016shares | Jan. 01, 2015shares | Apr. 30, 2010USD ($)periodshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($)shares |
Defined Benefit Plan Disclosure [Line Items] | ||||||
Compensation expense associated with the Company's matching plan | $ | $ 268,000 | $ 107,000 | $ 95,000 | |||
Annual discretionary profit-sharing contribution | $ | 0 | 0 | 0 | |||
Compensation expense recorded in connection with the Purchase Plan | $ | $ 5,037,000 | $ 3,850,000 | $ 2,477,000 | |||
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 | 72,261 | 34,915 | 26,123 | |||
Additional shares that became available for future issuance under the Purchase Plan | shares | 34,915 | |||||
Compensation expense recorded in connection with the Purchase Plan | $ | $ 109,000 | $ 47,000 | $ 21,000 | |||
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 | 72,261 |
Segment Information (Details)
Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Segment Reporting Information [Line Items] | |||||||||||
NET REVENUE | $ 5,823 | $ 6,901 | $ 5,776 | $ 3,938 | $ 1,741 | $ 2,408 | $ 2,190 | $ 2,084 | $ 22,438 | $ 8,423 | $ 1,872 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (469) | (634) | (376) | (283) | (130) | (372) | (376) | (564) | (1,762) | (1,442) | (1,863) |
GROSS PROFIT | 5,354 | 6,267 | 5,400 | 3,655 | 1,611 | 2,036 | 1,814 | 1,520 | 20,676 | 6,981 | 9 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 14,840 | 11,811 | 8,858 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 14,190 | 12,371 | 9,475 | ||||||||
SALES AND MARKETING EXPENSES | 28,090 | 15,087 | 15,942 | ||||||||
DEPRECIATION AND AMORTIZATION | 2,555 | 659 | 138 | ||||||||
OPERATING EXPENSES | 59,675 | 39,928 | 34,413 | ||||||||
NET LOSS FROM OPERATIONS | $ (9,761) | $ (8,444) | $ (9,800) | $ (10,994) | $ (10,920) | $ (8,625) | $ (5,958) | $ (7,444) | (38,999) | (32,947) | (34,404) |
OTHER INCOME AND EXPENSES, NET | 8,484 | (2,789) | (11,825) | ||||||||
NET LOSS BEFORE TAXES | (30,515) | (35,736) | (46,229) | ||||||||
U.S. | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
NET REVENUE | 15,170 | 17 | 0 | ||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (792) | (1) | 0 | ||||||||
GROSS PROFIT | 14,378 | 16 | 0 | ||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 9,712 | 5,400 | 4,110 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 8,244 | 7,496 | 5,048 | ||||||||
SALES AND MARKETING EXPENSES | 19,777 | 4,704 | 891 | ||||||||
DEPRECIATION AND AMORTIZATION | 2,491 | 657 | 138 | ||||||||
OPERATING EXPENSES | 40,224 | 18,257 | 10,187 | ||||||||
NET LOSS FROM OPERATIONS | (25,846) | (18,241) | (10,187) | ||||||||
International | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
NET REVENUE | 7,268 | 8,406 | 1,872 | ||||||||
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (970) | (1,441) | (1,863) | ||||||||
GROSS PROFIT | 6,298 | 6,965 | 9 | ||||||||
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 5,128 | 6,411 | 4,748 | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 5,946 | 4,875 | 4,427 | ||||||||
SALES AND MARKETING EXPENSES | 8,313 | 10,383 | 15,051 | ||||||||
DEPRECIATION AND AMORTIZATION | 64 | 2 | 0 | ||||||||
OPERATING EXPENSES | 19,451 | 21,671 | 24,226 | ||||||||
NET LOSS FROM OPERATIONS | $ (13,153) | $ (14,706) | $ (24,217) |
Selected Quarterly Financial 77
Selected Quarterly Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
NET REVENUE | $ 5,823 | $ 6,901 | $ 5,776 | $ 3,938 | $ 1,741 | $ 2,408 | $ 2,190 | $ 2,084 | $ 22,438 | $ 8,423 | $ 1,872 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (469) | (634) | (376) | (283) | (130) | (372) | (376) | (564) | (1,762) | (1,442) | (1,863) |
GROSS PROFIT | 5,354 | 6,267 | 5,400 | 3,655 | 1,611 | 2,036 | 1,814 | 1,520 | 20,676 | 6,981 | 9 |
NET LOSS FROM OPERATIONS | (9,761) | (8,444) | (9,800) | (10,994) | (10,920) | (8,625) | (5,958) | (7,444) | (38,999) | (32,947) | (34,404) |
NET LOSS | (10,713) | (1,543) | (8,596) | (9,793) | (9,258) | (7,009) | 1,116 | (20,759) | (30,645) | (35,910) | (46,229) |
NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ (10,713) | $ (1,543) | $ (8,596) | $ (9,793) | $ (10,008) | $ (7,009) | $ 1,116 | $ (20,759) | $ (30,645) | $ (36,660) | $ (51,179) |
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS — Basic and diluted (in dollars per share) | $ (0.24) | $ (0.03) | $ (0.19) | $ (0.22) | $ (0.69) | $ (0.91) | $ (1.62) | ||||
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS — Basic (in dollars per share) | $ (0.23) | $ (0.17) | $ 0.03 | $ (0.58) | |||||||
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS — Diluted (in dollars per share) | $ (0.23) | $ (0.17) | $ (0.16) | $ (0.58) |