Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 06, 2019 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | ALIMERA SCIENCES INC | |
Entity Central Index Key | 0001267602 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2019 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Smaller Reporting Company | true | |
Emerging Growth Company | false | |
Entity common stock, shares outstanding (in shares) | 71,000,495 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 13,094,000 | $ 13,043,000 |
Restricted cash | 33,000 | 32,000 |
Accounts receivable, net | 15,417,000 | 17,259,000 |
Prepaid expenses and other current assets | 2,469,000 | 2,109,000 |
Inventory (Note 7) | 1,860,000 | 2,405,000 |
Total current assets | 32,873,000 | 34,848,000 |
NON-CURRENT ASSETS: | ||
Property and equipment, net | 1,259,000 | 1,355,000 |
Right of use assets, net | 775,000 | |
Intangible asset, net (Note 8) | 16,245,000 | 16,723,000 |
Deferred tax asset | 1,158,000 | 1,182,000 |
TOTAL ASSETS | 52,310,000 | 54,108,000 |
CURRENT LIABILITIES: | ||
Accounts payable | 6,602,000 | 6,355,000 |
Accrued expenses (Note 9) | 3,118,000 | 3,643,000 |
Finance lease obligations | 253,000 | 236,000 |
Total current liabilities | 9,973,000 | 10,234,000 |
NON-CURRENT LIABILITIES: | ||
Note payable (Note 11) | 38,080,000 | 37,873,000 |
Finance lease obligations — less current portion | 241,000 | 305,000 |
Other non-current liabilities | 3,370,000 | 2,974,000 |
COMMITMENTS AND CONTINGENCIES | ||
STOCKHOLDERS’ EQUITY: | ||
Common stock, $.01 par value — 150,000,000 shares authorized, 70,968,630 shares issued and outstanding at March 31, 2019 and 70,078,878 shares issued and outstanding at December 31, 2018 | 710,000 | 701,000 |
Additional paid-in capital | 346,869,000 | 346,108,000 |
Common stock warrants | 3,707,000 | 3,707,000 |
Accumulated deficit | (379,890,000) | (377,127,000) |
Accumulated other comprehensive loss | (1,094,000) | (1,011,000) |
TOTAL STOCKHOLDERS’ EQUITY | 646,000 | 2,722,000 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | 52,310,000 | 54,108,000 |
Series A convertible preferred stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | 19,227,000 | 19,227,000 |
Series C convertible preferred stock | ||
STOCKHOLDERS’ EQUITY: | ||
Preferred stock | $ 11,117,000 | $ 11,117,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, shares issued (in shares) | 70,968,630 | 70,078,878 |
Common stock, shares outstanding (in shares) | 70,968,630 | 70,078,878 |
Series A convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 1,300,000 | 1,300,000 |
Preferred stock, shares issued (in shares) | 600,000 | 600,000 |
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 |
Preferred stock, liquidation preference | $ 24,000,000 | $ 24,000,000 |
Series C convertible preferred stock | ||
Preferred stock, shares authorized (in shares) | 10,150 | 10,150 |
Preferred stock, shares issued (in shares) | 10,150 | 10,150 |
Preferred stock, shares outstanding (in shares) | 10,150 | 10,150 |
Preferred stock, liquidation preference | $ 10,150,000 | $ 10,150,000 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Statement [Abstract] | ||
NET REVENUE | $ 12,890 | $ 9,630 |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,600) | (1,104) |
GROSS PROFIT | 11,290 | 8,526 |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 2,727 | 2,822 |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,393 | 3,855 |
SALES AND MARKETING EXPENSES | 5,913 | 5,969 |
DEPRECIATION AND AMORTIZATION | 652 | 649 |
OPERATING EXPENSES | 12,685 | 13,295 |
NET LOSS FROM OPERATIONS | (1,395) | (4,769) |
INTEREST EXPENSE AND OTHER | (1,228) | (1,151) |
UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET | (69) | 2 |
LOSS ON EARLY EXTINGUISHMENT OF DEBT | 0 | (1,766) |
NET LOSS BEFORE TAXES | (2,692) | (7,684) |
PROVISION FOR TAXES | (71) | 0 |
NET LOSS | $ (2,763) | $ (7,684) |
NET LOSS PER SHARE — Basic and diluted (USD per share) | $ (0.04) | $ (0.11) |
WEIGHTED AVERAGE SHARES OUTSTANDING — Basic and diluted (in shares) | 70,740,851 | 69,883,012 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement of Comprehensive Income [Abstract] | ||
NET LOSS | $ (2,763) | $ (7,684) |
OTHER COMPREHENSIVE INCOME | ||
Foreign currency translation adjustments | (83) | 106 |
TOTAL OTHER COMPREHENSIVE INCOME | (83) | 106 |
COMPREHENSIVE LOSS | $ (2,846) | $ (7,578) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (2,763,000) | $ (7,684,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 652,000 | 649,000 |
Unrealized foreign currency transaction loss (gain) | 69,000 | (2,000) |
Loss on early extinguishment of debt | 0 | 1,766,000 |
Amortization of debt discount | 206,000 | 214,000 |
Stock-based compensation expense | 770,000 | 1,207,000 |
Changes in assets and liabilities: | ||
Accounts receivable | 1,755,000 | (867,000) |
Prepaid expenses and other current assets | (381,000) | 309,000 |
Inventory | 532,000 | 299,000 |
Accounts payable | 301,000 | (992,000) |
Accrued expenses and other current liabilities | (857,000) | 70,000 |
Other long-term liabilities | 0 | (17,000) |
Net cash provided by (used in) operating activities | 284,000 | (5,048,000) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchases of property and equipment | (15,000) | (91,000) |
Net cash used in investing activities | (15,000) | (91,000) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from exercise of stock options | 0 | 2,000 |
Issuance of debt | 0 | 40,000,000 |
Payment of principal on notes payable | 0 | (35,000,000) |
Payment of extinguishment of debt costs | 0 | (2,544,000) |
Payment of deferred financing costs | 0 | (1,142,000) |
Payment of finance lease obligations | (110,000) | (83,000) |
Net cash (used in) provided by financing activities | (110,000) | 1,233,000 |
EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (107,000) | 93,000 |
NET CHANGE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 52,000 | (3,813,000) |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — Beginning of period | 13,075,000 | 24,101,000 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH — End of period | 13,127,000 | 20,288,000 |
SUPPLEMENTAL DISCLOSURES: | ||
Cash paid for interest | 1,012,000 | 932,000 |
Cash paid for income taxes | 4,000 | 0 |
Supplemental schedule of non-cash investing and financing activities: | ||
Property and equipment acquired under capital leases | 64,000 | 252,000 |
Note payable end of term payment accrued but unpaid | $ 0 | 1,800,000 |
Payments of dividends | $ 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Preferred StockSeries A Convertible Preferred Stock | Preferred StockSeries B Convertible Preferred Stock | Preferred StockSeries C Convertible Preferred Stock | Additional Paid-In Capital | Common Stock Warrants | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Beginning balance (in shares) at Dec. 31, 2017 | 69,146,381 | 600,000 | 8,416 | 0 | |||||
Beginning balance at Dec. 31, 2017 | $ 14,920 | $ 691 | $ 19,227 | $ 49,568 | $ 0 | $ 341,622 | $ 3,707 | $ (399,074) | $ (821) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuance of common stock, net of issuance costs (in shares) | 839,285 | ||||||||
Issuance of common stock, net of issuance costs | $ 0 | $ 9 | (9) | ||||||
Exercise of stock options (in shares) | 1,563 | 729 | |||||||
Exercise of stock options | $ 2 | 2 | |||||||
Stock-based compensation | 1,207 | 1,207 | |||||||
NET LOSS | (7,684) | (7,684) | |||||||
Foreign currency translation adjustments | 106 | 106 | |||||||
Ending balance (in shares) at Mar. 31, 2018 | 69,986,395 | 600,000 | 8,416 | 0 | |||||
Ending balance at Mar. 31, 2018 | 8,551 | $ 700 | $ 19,227 | $ 49,568 | $ 0 | 342,822 | 3,707 | (406,758) | (715) |
Beginning balance (in shares) at Dec. 31, 2018 | 70,078,878 | 600,000 | 0 | 10,150 | |||||
Beginning balance at Dec. 31, 2018 | 2,722 | $ 701 | $ 19,227 | $ 0 | $ 11,117 | 346,108 | 3,707 | (377,127) | (1,011) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||
Issuance of common stock, net of issuance costs (in shares) | 889,752 | ||||||||
Issuance of common stock, net of issuance costs | $ 0 | $ 9 | (9) | ||||||
Exercise of stock options (in shares) | 0 | ||||||||
Stock-based compensation | $ 770 | 770 | |||||||
NET LOSS | (2,763) | (2,763) | |||||||
Foreign currency translation adjustments | (83) | (83) | |||||||
Ending balance (in shares) at Mar. 31, 2019 | 70,968,630 | 600,000 | 0 | 10,150 | |||||
Ending balance at Mar. 31, 2019 | $ 646 | $ 710 | $ 19,227 | $ 0 | $ 11,117 | $ 346,869 | $ 3,707 | $ (379,890) | $ (1,094) |
Nature of Operations
Nature of Operations | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | NATURE OF OPERATIONS Alimera Sciences, Inc., together with its wholly-owned subsidiaries (the Company), is a pharmaceutical company that specializes in the commercialization and development of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware. The Company is presently focused on diseases affecting the back of the eye, or retina, because the Company’s management believes these diseases are not well treated with current therapies and represent a significant market opportunity. The Company’s only commercial product is ILUVIEN ® , which has received marketing authorization in the United States (U.S.), Austria, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, Sweden, the United Arab Emirates and the United Kingdom. In the U.S., Canada, Kuwait, Lebanon and the United Arab Emirates, 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 and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye in countries where the Company has satisfied the country's labeling requirements and the Company is now permitted to market ILUVIEN. The Company has completed enrollment into a five -year, post-authorization, open label registry study in patients treated with ILUVIEN. In total, 562 patients enrolled in this study, and the Company anticipates the follow up period to be completed in early 2020. The Company commercially markets ILUVIEN directly in the U.S., Germany, the United Kingdom, Portugal, Austria and Ireland. In addition, the Company has entered into various agreements under which distributors will provide regulatory, reimbursement or sales and marketing support for commercialization or future commercialization of ILUVIEN in France, Italy, Spain, Australia, New Zealand, Canada and several countries in the Middle East. In 2016, the Company’s Middle East distributor launched ILUVIEN and initiated named patient sales in the United Arab Emirates. The Company’s Italian distributor launched ILUVIEN in Italy in 2017. The Company’s Spanish distributor began selling on a named patient basis in 2017 and is currently pursuing reimbursement at the national level. The Company’s French distributor received pricing and reimbursement approval in March 2019 for ILUVIEN for DME and began selling in April 2019. The Company’s Canadian distributor is currently pursuing reimbursement. As of March 31, 2019, the Company has recognized sales of ILUVIEN to the Company’s international distributors in the Middle East, France, Italy and Spain. In July 2017, the Company amended its license with EyePoint Pharmaceuticals US, Inc. (EyePoint) formerly known as pSivida US, Inc. for the technology underlying ILUVIEN to include the treatment of uveitis, including non-infectious posterior uveitis (NIPU) in Europe, the Middle East and Africa (See Note 10). Uveitis is an inflammatory disease of the uveal tract, which is comprised of the iris, ciliary body and choroid, that can lead to severe vision loss and blindness. In December 2017, the Company filed an application for a new indication for ILUVIEN for NIPU in the 17 EEA countries where ILUVIEN is currently approved for the treatment of DME. The regulatory authorities requested additional follow-up data from the clinical trials to support the application, which was submitted in October 2018. In March 2019, the Company received the Final Variation Assessment Report (FVAR) for ILUVIEN from the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) based on the Company’s submission to the MHRA through the Mutual Recognition Procedure. Under that procedure, the United Kingdom has acted as the Reference Member State and prepared an assessment report to share with the 16 other countries in the EEA in which the Company applied for an additional indication. The FVAR states that ILUVIEN is approved for the additional indication for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye, or NIPU. |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | BASIS OF PRESENTATION The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information, the instructions to Form 10-Q and Article 10-01 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information. The accompanying interim financial statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2018 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on February 25, 2019. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company's accounting policies followed for quarterly financial reporting are the same as those disclosed in the Notes to Financial Statements included in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2018. Research and Development Expenses Research and development expenses were $197,000 and $104,000 for the three months ended March 31, 2019 and 2018 , respectively. Prior period reclassification An immaterial reclassification of prior period amounts related to revenue and cost of goods sold, excluding depreciation and amortization has been made to conform to the current period presentation. This reclassification did not have any impact on gross profit, net loss from operations or net loss. Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (FASB) or other standard setting bodies issue new accounting pronouncements that we adopt as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. Adoption of New Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842) , to increase transparency and comparability among organizations for lease recognition and disclosure. ASU 2016-02 requires lessees to recognize lease assets and lease liabilities on the balance sheet, while recognizing expenses on the income statements in a manner similar to current guidance. ASU 2016-02 became effective for fiscal years and interim periods for the Company in the first quarter of 2019. ASU 2016-02 requires that leases be recognized and measured as of the earliest period presented, using a modified retrospective approach, with all periods presented being adjusted and presented under the new standard. In July 2018, the FASB issued ASU 2018-11, Leases (ASC 842) : Targeted Improvements, which provides companies an optional adoption method to ASU 2016-02 whereby a company does not have to adjust comparative period financial statements for the new standard. The Company adopted this ASU on January 1, 2019 and did not restate comparative periods. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company also made an accounting policy election to not recognize right of use assets and liabilities for leases with a term of 12 months or less, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. See Note 5 for expanded disclosures. In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , to allow reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. Upon adoption of the ASU, entities are required to describe the accounting policy for releasing income tax effects from accumulated other comprehensive income. The Company adopted this standard on January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial statements. In June 2018, the FASB issued ASU No. 2018-07, Stock-based Compensation: Improvements to Nonemployee Share-based Payment Accounting , which amends the existing accounting standards for share-based payments to nonemployees. This ASU aligns much of the guidance on measuring and classifying nonemployee awards with that of awards to employees. Under the new guidance, the measurement of nonemployee equity awards is fixed on the grant date. This ASU became effective on January 1, 2019, and the Company adopted it at that time. Entities will apply the ASU by recognizing a cumulative-effect adjustment to retained earnings as of the beginning of the annual period of adoption. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard is effective for annual periods beginning after December 15, 2019, including interim periods within those annual periods, with early adoption available. The Company is in the process of determining the effect that the adoption will have on its financial statements. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | REVENUE RECOGNITION Net Revenue The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. All of the Company’s current contracts have a single performance obligation, as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and is, therefore, not distinct. Currently, all of the Company’s revenue is derived from product sales. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. As of March 31, 2019, the Company had received a total of $1,000,000 of payments that it has not recognized as revenue based on the Company’s analysis in connection with Topic 606. These deferred revenues are included as a component of other non-current liabilities on the Company’s balance sheets. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may either refund the sales price paid by the Customer by issuing a credit or exchanging the returned product for replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. The estimation process for product returns involves, in each case, a number of interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal. Other Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides; and a revenue share on net sales of licensed products. Each of these payments is recognized as other revenues. As part of the accounting for these arrangements, the Company must develop estimates that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Performance obligations are promises in a contract to transfer a distinct good or service to the Customer, and the Company recognizes revenue when, or as, performance obligations are satisfied. The Company uses key assumptions to determine the stand-alone selling price; these assumptions may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Certain of these agreements include consideration in the form of milestone payments. At the inception of each arrangement that includes milestone payments, the Company evaluates the recognition of milestone payments. Typically, milestone payments are associated with events that are not entirely within the control of the Company or the licensee, such as regulatory approvals; are included in the transaction price; and are subject to a constraint until it is probable that there will not be a significant revenue reversal, typically upon achievement of the milestone. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the timing of receipt of payment for the Company’s international Customers can be extended. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services in one year or less of receiving those products or services. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | LEASES The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right of use assets and accounts for these, as applicable, at inception of the contract. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right of use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component. Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has determined it is not reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term. Operating Leases The Company’s operating lease activities primarily consist of leases for office space in the U.S., the United Kingdom and Germany. Most of these leases include options to renew, with renewal terms generally ranging from one to seven years . The exercise of lease renewal options is at the Company’s sole discretion. The Company has determined it is not reasonably certain it will exercise any of its renewal options. Certain of the Company’s operating lease agreements include variable lease costs that are based on common area maintenance and property taxes. The Company expenses these payments as incurred. The Company’s operating lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of March 31, 2019 for the Company’s operating leases is as follows: (in thousands) NON-CURRENT ASSETS: Right of use assets, net $ 775 Total lease assets $ 775 CURRENT LIABILITIES: Accrued expenses (Note 9) $ 433 NON-CURRENT LIABILITIES: Other non-current liabilities 560 Total lease liabilities $ 993 The Company’s operating lease cost for the three months ended March 31, 2019 was $123,000 and is included in general and administrative expenses in its Condensed Consolidated Statement of Operations. As of March 31, 2019, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2019 (remaining) $ 394 2020 412 2021 299 Total 1,105 Less amount representing interest (112 ) Present value of minimum lease payments 993 Less current portion (433 ) Non-current portion $ 560 Cash paid for operating leases was $100,000 during the three months ended March 31, 2019. An insignificant amount of right of use assets was obtained in exchange for operating leases for the three months ended March 31, 2019. As of March 31, 2019, the weighted average remaining lease terms of the Company’s operating leases was 2.1 years . The weighted average discount rate used to determine the lease liabilities was 10.2% . When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company's leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms. Upon adoption of the new lease standard, discount rates used for existing leases were established at January 1, 2019. Finance Leases The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. The property and equipment is capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of March 31, 2019 and December 31, 2018 for the Company’s finance leases are as follows: March 31, 2019 December 31, 2018 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 602 $ 615 Total lease assets $ 602 $ 615 CURRENT LIABILITIES: Finance lease obligations $ 253 $ 236 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 241 305 Total lease liabilities $ 494 $ 541 Depreciation expense associated with property and equipment under finance leases was approximately $76,000 and $49,000 for the three months ended March 31, 2019 and 2018, respectively. Interest expense associated with finance leases was $9,000 and $6,000 for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows: Years Ending December 31 (In thousands) 2019 (remaining) $ 211 2020 253 2021 65 2022 3 Total 532 Less amount representing interest (38 ) Present value of minimum lease payments 494 Less current portion (253 ) Non-current portion $ 241 Cash paid for finance leases was $100,000 during the three months ended March 31, 2019. The Company acquired $64,000 of property and equipment in exchange for finance leases for the three months ended March 31, 2019. As of March 31, 2019, the weighted average remaining lease terms of the Company’s financing leases was 1.8 years . The weighted average discount rate used to determine the financing lease liabilities was 7.0% . When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company's leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms. |
Leases | LEASES The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right of use assets and accounts for these, as applicable, at inception of the contract. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right of use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component. Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has determined it is not reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term. Operating Leases The Company’s operating lease activities primarily consist of leases for office space in the U.S., the United Kingdom and Germany. Most of these leases include options to renew, with renewal terms generally ranging from one to seven years . The exercise of lease renewal options is at the Company’s sole discretion. The Company has determined it is not reasonably certain it will exercise any of its renewal options. Certain of the Company’s operating lease agreements include variable lease costs that are based on common area maintenance and property taxes. The Company expenses these payments as incurred. The Company’s operating lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of March 31, 2019 for the Company’s operating leases is as follows: (in thousands) NON-CURRENT ASSETS: Right of use assets, net $ 775 Total lease assets $ 775 CURRENT LIABILITIES: Accrued expenses (Note 9) $ 433 NON-CURRENT LIABILITIES: Other non-current liabilities 560 Total lease liabilities $ 993 The Company’s operating lease cost for the three months ended March 31, 2019 was $123,000 and is included in general and administrative expenses in its Condensed Consolidated Statement of Operations. As of March 31, 2019, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2019 (remaining) $ 394 2020 412 2021 299 Total 1,105 Less amount representing interest (112 ) Present value of minimum lease payments 993 Less current portion (433 ) Non-current portion $ 560 Cash paid for operating leases was $100,000 during the three months ended March 31, 2019. An insignificant amount of right of use assets was obtained in exchange for operating leases for the three months ended March 31, 2019. As of March 31, 2019, the weighted average remaining lease terms of the Company’s operating leases was 2.1 years . The weighted average discount rate used to determine the lease liabilities was 10.2% . When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company's leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms. Upon adoption of the new lease standard, discount rates used for existing leases were established at January 1, 2019. Finance Leases The Company’s finance lease activities primarily consist of leases for office equipment and automobiles. The property and equipment is capitalized at the lesser of fair market value or the present value of the minimum lease payments at the inception of the leases using the Company’s incremental borrowing rate. The Company’s finance lease agreements do not contain any material residual value guarantees or material restrictive covenants. Supplemental balance sheet information as of March 31, 2019 and December 31, 2018 for the Company’s finance leases are as follows: March 31, 2019 December 31, 2018 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 602 $ 615 Total lease assets $ 602 $ 615 CURRENT LIABILITIES: Finance lease obligations $ 253 $ 236 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 241 305 Total lease liabilities $ 494 $ 541 Depreciation expense associated with property and equipment under finance leases was approximately $76,000 and $49,000 for the three months ended March 31, 2019 and 2018, respectively. Interest expense associated with finance leases was $9,000 and $6,000 for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows: Years Ending December 31 (In thousands) 2019 (remaining) $ 211 2020 253 2021 65 2022 3 Total 532 Less amount representing interest (38 ) Present value of minimum lease payments 494 Less current portion (253 ) Non-current portion $ 241 Cash paid for finance leases was $100,000 during the three months ended March 31, 2019. The Company acquired $64,000 of property and equipment in exchange for finance leases for the three months ended March 31, 2019. As of March 31, 2019, the weighted average remaining lease terms of the Company’s financing leases was 1.8 years . The weighted average discount rate used to determine the financing lease liabilities was 7.0% . When available, the Company uses the rate implicit in the lease or sublease to discount lease payments to present value; however, most of the Company's leases do not provide a readily determinable implicit rate. Therefore, the Company must estimate its incremental borrowing rate to discount the lease payments based on information available at lease commencement. The incremental borrowing rate is defined as the rate of interest that the Company would have to pay to borrow, on a collateralized basis and over a similar term, an amount equal to the lease payments in a similar economic environment. In using the Company’s incremental borrowing rate, management has elected to utilize a portfolio approach and applies the rates to a portfolio of leases with similar underlying assets and terms. |
Going Concern
Going Concern | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Going Concern | GOING CONCERN The accompanying Interim Financial Statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Interim Financial Statements do not include any adjustments that might result from the outcome of this uncertainty. To date, the Company has incurred recurring losses and negative cash flow from operations and has accumulated a deficit of $379,890,000 from inception through March 31, 2019 . As of March 31, 2019 , the Company had approximately $13,094,000 in cash and cash equivalents. The Company’s ability to achieve profitability and positive cash flow depends upon its ability to increase revenue and contain its expenses. Further, the Company must maintain compliance with the debt covenants of its $40,000,000 Loan and Security Agreement dated January 5, 2018 with Solar Capital Ltd. as Collateral Agent, and the parties signing such agreement from time to time as Lenders, including Solar Capital in its capacity as a Lender (see Note 11). In management’s opinion, the uncertainty regarding future revenues raises substantial doubt about the Company’s ability to continue as a going concern without access to additional debt and/or equity financing, over the course of the next twelve months. To meet the Company’s future working capital needs, the Company may need to raise additional debt or equity financing. While the Company has historically been able to raise additional capital through issuance of equity and/or debt financing, and while the Company has implemented a plan to control its expenses to satisfy its obligations due within one year from the date of issuance of these Interim Financial Statements, the Company cannot guarantee that it will be able to maintain debt compliance, raise additional equity, contain expenses, or increase revenue. Accordingly, there is substantial doubt about the Company’s ability to continue as a going concern within one year after these Interim Financial Statements are issued. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY Inventory consisted of the following: March 31, 2019 December 31, 2018 (In thousands) Component parts (1) $ 413 $ 129 Work-in-process (2) 111 924 Finished goods 1,336 1,352 Total Inventory $ 1,860 $ 2,405 (1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing or stability testing as required by U.S. or EEA regulatory authorities. |
Intangible Asset
Intangible Asset | 3 Months Ended |
Mar. 31, 2019 | |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |
Intangible Asset | INTANGIBLE ASSET As a result of the approval of ILUVIEN by the U.S. Food and Drug Administration (FDA) in 2014, the Company was required to pay EyePoint a milestone payment of $25,000,000 (the EyePoint Milestone Payment) (see Note 10). The gross carrying amount of the intangible asset is $25,000,000 , which is being amortized over approximately 13 years from the acquisition date. The amortization expense related to the intangible asset was approximately $478,000 for both the three months ended March 31, 2019 and 2018 , respectively. The net book value of the intangible asset was $16,245,000 and $16,723,000 as of March 31, 2019 and December 31, 2018, respectively. The estimated future amortization expense as of March 31, 2019 for the remaining periods in the next five years and thereafter is as follows: Years Ending December 31 (In thousands) 2019 $ 1,462 2020 1,946 2021 1,940 2022 1,940 2023 1,940 Thereafter 7,017 Total $ 16,245 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | ACCRUED EXPENSES Accrued expenses consisted of the following: March 31, 2019 December 31, 2018 (In thousands) Accrued clinical investigator expenses $ 840 $ 781 Accrued compensation expenses 1,212 1,427 Accrued rebate, chargeback and other revenue reserves 385 346 Accrued lease liabilities (Note 5) 433 — Other accrued expenses 248 1,089 Total accrued expenses $ 3,118 $ 3,643 |
License Agreements
License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | LICENSE AGREEMENTS EyePoint Agreement In February 2005, the Company entered into an agreement with EyePoint (formerly known as pSivida US, Inc.) for the use of fluocinolone acetonide (FAc) in EyePoint’s proprietary insert technology. This agreement was subsequently amended a number of times (as amended, the EyePoint Agreement). The EyePoint Agreement provides the Company with a worldwide exclusive license to utilize certain underlying technology used in the development and commercialization of ILUVIEN. 2008 Amended and Restated Collaboration Agreement Pursuant to the payment terms of the 2008 Amended and Restated Agreement (the 2008 Agreement), the Company was required to share with EyePoint 20% of the net profits of ILUVIEN, determined on a cash basis and 33% of any lump sum milestone payments received from a sub-licensee of ILUVIEN. In connection with this arrangement, the Company was entitled to recover out of EyePoint’s share of the net profits of ILUVIEN, 20% of ILUVIEN’s commercialization costs (as defined in the EyePoint Agreement) that were incurred prior to product profitability. (The Company’s future rights to recover these amounts from EyePoint are referred to as the Future Offset.) In connection with the New Collaboration Agreement discussed below, the Future Offset was further amended. New Collaboration Agreement - Second Amended and Restated Collaboration Agreement On July 10, 2017, the Company and EyePoint entered into a Second Amended and Restated Collaboration Agreement (the New Collaboration Agreement), which amends and restates the EyePoint Agreement. Prior to entering into the New Collaboration Agreement, the Company held the worldwide license from EyePoint for the use of EyePoint’s proprietary insert technology for the treatment of all ocular diseases other than uveitis. The New Collaboration Agreement expands the license to include uveitis, including NIPU, in Europe, the Middle East and Africa and also allows the Company to pursue an indication for posterior uveitis for ILUVIEN in those territories. The New Collaboration Agreement converted the Company’s previous profit share obligation to a royalty payable on global net revenues of ILUVIEN. The Company began paying a 2% royalty on net revenues and other related consideration to EyePoint on July 1, 2017. This royalty amount increased to 6% effective December 12, 2018. Pursuant to the New Collaboration Agreement, the Company is required to pay an additional 2% royalty on global net revenues and other related consideration in excess of $75,000,000 in any year. During the three months ended March 31, 2019 and 2018, the Company recognized approximately $516,000 and $193,000 of royalty expense, respectively, which is included in cost of goods sold, excluding depreciation and amortization. As of March 31, 2019 , approximately $516,000 of royalty expense was included in the Company’s accounts payable. In connection with the New Collaboration Agreement, the Company and EyePoint first agreed to cap the Future Offset amount at $25,000,000 as of June 30, 2017 and the Company then agreed to forgive $10,000,000 of the total $25,000,000 of the Future Offset at the July 10, 2017 amendment date. Following the signing of the New Collaboration Agreement, the Company retained a right to recover up to the remaining $15,000,000 of the Future Offset. Due to the uncertainty of future net profits, the Company has fully reserved the Future Offset in the accompanying Interim Financial Statements. In March 2019, pursuant to the New Collaboration Agreement, the Company forgave $5,000,000 of the Future Offset in connection with the approval of ILUVIEN for NIPU in the United Kingdom. As of March 31, 2019, the balance of the Future Offset was approximately $9,820,000 . The Company will be able to recover the balance of the Future Offset as a reduction of future royalties that would otherwise be owed to EyePoint as follows: • In the first two years following the December 12, 2018 increase in royalty amount to 6% , the royalty will be reduced to 4% for net revenues and other related consideration up to $75,000,000 annually and 5% , rather than 8% , for net revenues and other related consideration in excess of $75,000,000 on an annual basis; and • Beginning with the third year following the December 12, 2018 increase in royalty amount to 6% , the royalty will be reduced to approximately 5.2% for net revenues and other related consideration up to $75,000,000 annually and to approximately 6.8% , rather than 8% , for net revenues and other related consideration in excess of $75,000,000 on an annual basis. Possible Reversion of the Company’s License Rights to EyePoint The Company’s license rights to EyePoint’s proprietary delivery device could revert to EyePoint if the Company were to: (i) fail twice to cure its breach of an obligation to make certain payments to EyePoint following receipt of written notice thereof; (ii) fail to cure other breaches of material terms of the New Collaboration Agreement within 30 days after notice of such breaches or such longer period (up to 90 days ) as may be reasonably necessary if the breach cannot be cured within such 30 -day period; (iii) file for protection under the bankruptcy laws, make an assignment for the benefit of creditors, appoint or suffer appointment of a receiver or trustee over its property, file a petition under any bankruptcy or insolvency act or have any such petition filed against it and such proceeding remains undismissed or unstayed for a period of more than 60 days ; or (iv) notify EyePoint in writing of its decision to abandon its license with respect to a certain product using EyePoint’s proprietary delivery device. |
Loan Agreements
Loan Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Loan Agreements | LOAN AGREEMENTS Hercules Loan Agreement In April 2014, Alimera Sciences Limited (Alimera UK), a subsidiary of the Company, entered into a loan and security agreement (Hercules Loan Agreement) with Hercules Capital, Inc. (Hercules) providing for a term loan of up to $35,000,000 (Hercules Loan). The Company amended the Hercules Loan Agreement several times. On October 20, 2016 Alimera UK and Hercules entered into a fourth amendment to the Hercules Loan Agreement (the Fourth Loan Amendment), which provided the operative loan agreement terms during 2017 and the beginning of 2018. On January 5, 2018, the Company paid off the Hercules Loan on behalf of Alimera UK. The Fourth Loan Amendment provided for interest only payments that were scheduled through November 30, 2018. Pursuant to the Fourth Loan Amendment, interest on the Hercules Loan accrued at a floating per annum rate equal the greater of (i) 11.0% or (ii) the sum of (A) 11.0% plus (B) the prime rate as reported in The Wall Street Journal, or if not reported, the prime rate most recently reported in The Wall Street Journal, minus 3.5% . In addition to the interest described above, the principal balance of the Hercules Loan bore “payment-in kind” interest at the rate of 1.0% (PIK Interest), which PIK Interest was added to the outstanding principal balance of the Hercules Loan. The interest rate on the Hercules Loan Agreement was 12.0% when the Company paid it off. Under the Hercules Loan Agreement as amended by the Fourth Loan Amendment, any principal prepayment of the Hercules loan triggered a prepayment penalty based on when the prepayment occurred. When the Company prepaid the Hercules Loan Agreement on January 5, 2018, the Company paid 2.0% of the principal amount repaid, or $709,000 , which is included in loss on early extinguishment of debt for the three months ended March 31, 2018. Before Alimera UK entered into the Fourth Loan Agreement, Alimera UK was already obligated to pay an end of term payment of $1,400,000 , which was paid when the Company paid off the Hercules loan on January 5, 2018. 2014 Warrant In connection with Alimera UK entering into the Hercules Loan Agreement, the Company issued a warrant that granted Hercules the right to purchase up to 285,016 shares of the Company’s common stock at an exercise price of $6.14 per share (the 2014 Warrant). The Company amended the 2014 Warrant a number of times to increase the number of shares issuable upon exercise to 1,258,993 and decrease the exercise price to $1.39 per share. The right to exercise this warrant expires on November 2, 2020. 2016 Warrant In connection with Alimera UK entering into the Fourth Loan Amendment, the Company agreed to issue a new warrant to Hercules (the 2016 Warrant) that granted Hercules the right to purchase up to 458,716 shares of the Company’s common stock at an exercise price of $1.09 per share. The right to exercise this warrant expires on October 20, 2021. Solar Capital Loan Agreement On January 5, 2018, the Company entered into a $40,000,000 Loan and Security Agreement (2018 Loan Agreement) with Solar Capital Ltd. (Solar Capital), as Collateral Agent (Agent), and the parties signing the 2018 Loan Agreement from time to time as Lenders, including Solar Capital in its capacity as a Lender (collectively, the Lenders). Under the 2018 Loan Agreement, the Company borrowed the entire $40,000,000 as a term loan that matures on July 1, 2022. The Company used the proceeds of the term loan to extinguish the Hercules Loan Agreement and pay related expenses. The Company used the remaining loan proceeds to provide additional working capital for general corporate purposes. Interest on the 2018 Loan Agreement is payable at one-month LIBOR plus 7.65% per annum. The 2018 Loan Agreement provides for interest only payments for the first 30 months ending on July 1, 2020, followed by 24 months of payments of principal and interest. If the Company meets certain revenue thresholds and no event of default shall have occurred and is continuing, the Company can extend the interest only period an additional six months to end on January 1, 2021, followed by 18 months of payments of principal and interest. As of March 31, 2019 , the interest rate on the 2018 Loan Agreement was approximately 10.1% . As part of the fees and expenses incurred in conjunction with the 2018 Loan Agreement discussed above, the Company paid Solar Capital a $400,000 fee at closing. The Company is obligated to pay a $1,800,000 fee upon repayment of the term loan in full ( $2,000,000 if the interest only period has been extended to 36 months ). The Company may elect to prepay the outstanding principal balance of the 2018 Loan Agreement in increments of $10,000,000 or more. The Company must pay a prepayment premium upon any prepayment of the 2018 Loan Agreement before its maturity date, whether by mandatory or voluntary prepayment, acceleration or otherwise, equal to: a. 2.00% of the principal amount prepaid for a prepayment made on or after January 5, 2018 through and including January 5, 2019; b. 1.00% of the principal amount prepaid for a prepayment made after January 5, 2019 through and including January 5, 2020; and c. 0.50% of the principal amount prepaid for a prepayment made after January 5, 2020 and greater than 30 days before the maturity date. The Company is also obligated to pay additional fees under the Exit Fee Agreement (Exit Fee Agreement) dated as of January 5, 2018 by and among the Company, Solar Capital as Agent, and the Lenders. The Exit Fee Agreement survives the termination of the 2018 Loan Agreement and has a term of 10 years. The Company is obligated to pay up to, but no more than, $2,000,000 in fees under the Exit Fee Agreement. Specifically, the Company is obligated to pay an exit fee of $2,000,000 upon a “change in control” (as defined in the Exit Fee Agreement). To the extent that Alimera has not already paid the $2,000,000 fee, the Company is also obligated to pay a fee of $1,000,000 on achieving each of the following milestones: a. first, if the Company achieves revenues of $80,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured on a trailing 12-month basis during the term of the agreement, tested at the end of each month; and b. second, if the Company achieves revenues of $100,000,000 or more from the sale of its ILUVIEN product in the ordinary course of business to third party customers, measured in the same manner. The Company agreed, for itself and its subsidiaries, to customary affirmative and negative covenants and events of default in connection with the 2018 Loan Agreement. The occurrence of an event of default could result in the acceleration of the Company’s obligations under the 2018 Loan Agreement and an increase to the applicable interest rate, and would permit Solar Capital to exercise remedies with respect to the collateral under the 2018 Loan Agreement. The Company’s obligations to Agent and the Lenders are secured by a first priority security interest in substantially all of the assets, excluding intellectual property, of the Company and its wholly owned subsidiary, Alimera Sciences (DE), LLC (Alimera DE), which is a guarantor of the loan, provided that only 65% of the voting interests in AS C.V., a Dutch subsidiary owned by the Company and Alimera DE, are pledged to the Lenders, and no assets or equity interests in the direct or indirect subsidiaries of AS C.V. are subject to the Lenders’ security interests. The Lender does, however, maintain a negative pledge on the property of the Company and all of its subsidiaries, including the Company’s intellectual property, requiring the Lender’s consent for any liens (other than typical permitted liens) on, or the sale of, such property. Extinguishment of Debt In accordance with the guidance in ASC 470-50, Debt , the Company accounted for the extinguishment of the Hercules Loan Agreement as an extinguishment and recognized a loss on early extinguishment of debt of approximately $1,766,000 within the condensed consolidated statements of operations for the three months ended March 31, 2018. The loss on early extinguishment consisted primarily of the early termination fee paid to Hercules and unamortized debt discounts including the remaining portion of warrant values and debt issuance costs. 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 March 31, 2019 and December 31, 2018 . |
Earnings (Loss) Per Share (EPS)
Earnings (Loss) Per Share (EPS) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per Share (EPS) | EARNINGS (LOSS) PER SHARE (EPS) The Company follows ASC 260, Earnings Per Share (ASC 260), which requires the reporting of both basic and diluted earnings per share. Because the Company’s preferred stockholders participate in dividends equally with common stockholders (if the Company were to declare and pay dividends), the Company uses the two-class method to calculate EPS. However, the Company’s preferred stockholders are not contractually obligated to share in losses. Basic EPS is computed by dividing net income (loss) available to stockholders by the weighted average number shares outstanding for the period. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average shares outstanding for the dilutive effect of common stock options, restricted stock units and warrants. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Three Months Ended 2019 2018 Series A convertible preferred stock 9,022,556 9,022,556 Series B convertible preferred stock — 8,416,251 Series C convertible preferred stock 10,150,000 — Common stock warrants 1,795,663 1,795,663 Stock options 13,407,536 12,343,820 Restricted stock units 480,400 1,039,370 Total 34,856,155 32,617,660 |
Preferred Stock
Preferred Stock | 3 Months Ended |
Mar. 31, 2019 | |
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 (Series A Preferred Stock) and warrants to purchase 300,000 shares of Series A 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 Preferred Stock are set forth in the certificate of designation for the Series A Preferred Stock filed by the Company with the Delaware Secretary of State as part of the Company’s certificate of incorporation. Each share of Series A Preferred Stock 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 Preferred Stock shall automatically be converted into shares of common stock at the then-effective Conversion Price upon 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 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 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 additional shares of Series A Preferred Stock. The rights to exercise these warrants expired on October 1, 2017. In 2014, the Company issued 6,015,037 shares of common stock pursuant to the conversion of 400,000 shares of Series A Preferred Stock. As of March 31, 2019, there were 600,000 shares of Series A Preferred Stock issued and outstanding. Series B Convertible Preferred Stock On December 12, 2014, the Company closed a preferred stock financing in which it sold 8,291.873 shares of Series B Convertible Preferred Stock (Series B Preferred Stock) for a purchase price of $6,030 per share, or an aggregate purchase price of $50,000,000 , prior to the payment of approximately $432,000 of related issuance costs. The Company issued an additional 124.378 shares of Series B Preferred Stock as a subscription premium to the purchasers. On September 4, 2018, all of the outstanding shares of Series B Preferred Stock were exchanged for shares of Series C Convertible Preferred Stock (see below). On September 4, 2018, following the closing of the exchange of all outstanding shares of Series B Preferred Stock for shares of Series C Convertible Preferred Stock, the Company filed with the Delaware Secretary of State a Certificate of Elimination of Series B Convertible Preferred Stock of Alimera Sciences, Inc., which eliminated from the Company’s amended and restated certificate of incorporation, as amended, the Alimera Sciences, Inc. Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock. As a result, all shares of the Company’s preferred stock previously designated as Series B Convertible Preferred Stock were eliminated and returned to the status of authorized but unissued shares of preferred stock, without designation as to series. Series C Convertible Preferred Stock On September 4, 2018, the Company entered into and closed a Series B Preferred Stock Exchange Agreement (Exchange Agreement) with the holders of all of the outstanding approximately 8,416 shares of Series B Preferred Stock. Under the Exchange Agreement, the holders of Series B Preferred Stock exchanged their shares of Series B Preferred Stock for an aggregate of 10,150 shares of Series C Convertible Preferred Stock, par value $0.01 per share (Series C Preferred Stock). The powers, preferences and rights of the Series C Preferred Stock are set forth in the certificate of designation filed by the Company with the Delaware Secretary of State as part of the Company’s certificate of incorporation, as amended. All of the outstanding shares of Series B Preferred Stock were canceled in the exchange. The Company incurred approximately $122,000 in legal costs related to the Exchange Agreement. The 10,150 issued and outstanding shares of Series C Preferred Stock have an aggregate stated value of $10,150,000 and are convertible into shares of the Company’s common stock at $1.00 per share, or 10,150,000 shares of the Company’s common stock in total, at any time at the option of the holder, provided that the holder will be prohibited from converting shares of Series C 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 C Preferred Stock is not redeemable at the option of the holder. In the event of a liquidation, dissolution or winding up of the Company and in the event of certain mergers, tender offers and asset sales, the holders of the Series C Preferred Stock will receive the greater of (a) the liquidation preference equal to $10,150,000 in the aggregate, plus any declared but unpaid dividends, or (b) the amount such holders would receive had all shares of the Series C Preferred Stock been converted into the Company’s common stock immediately before such event. With respect to rights upon liquidation, the Series C Preferred Stock ranks junior to the Company’s Series A Preferred Stock and senior to the Company’s common stock. The Series C 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 C Preferred Stock does not have voting rights. The Series C Preferred Stock is not subject to any price-based anti-dilution protections and does not provide for any accruing dividends. The Company determined that the Exchange Agreement resulted in an extinguishment of the Series B Preferred Stock. As a result, the Company recognized a gain of $38,330,000 on the extinguishment of preferred stock during the third quarter of 2018. As of the transaction date, the Company made an assessment of the fair market value of the Series C Preferred Stock and calculated the value to be $11,239,000 , prior to the payment of approximately $122,000 of related transaction costs. The Company recorded this gain within stockholders’ equity and as an increase to earnings available to stockholders during the third quarter of 2018. The $38,330,000 gain on extinguishment of preferred stock was derived by the difference in the fair market value of the Series C Preferred Stock and the carrying value of the Series B Preferred Stock. |
Stock Incentive Plans
Stock Incentive Plans | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Incentive Plans | STOCK INCENTIVE PLANS Stock Option Plans During the three months ended March 31, 2019 and 2018, the Company recorded compensation expense related to stock options of approximately $545,000 and $866,000 , respectively. As of March 31, 2019, the total unrecognized compensation cost related to non-vested stock options granted was $2,964,000 and is expected to be recognized over a weighted average period of 2.52 years . The following table presents a summary of stock option activity for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 12,447,355 $ 2.63 11,595,510 $ 2.90 Grants 1,174,750 0.87 1,233,000 1.16 Forfeitures (214,569 ) 1.99 (483,127 ) 2.34 Exercises — — (1,563 ) 1.06 Options outstanding at period end 13,407,536 2.48 12,343,820 2.75 Options exercisable at period end 9,536,065 3.02 8,168,883 3.24 Weighted average per share fair value of options granted during the period $ 0.55 $ 0.78 The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of March 31, 2019 : Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 13,407,536 $ 2.48 6.29 years $ 321 Exercisable 9,536,065 3.02 5.24 years 53 Outstanding, vested and expected to vest 12,885,031 2.54 6.17 years 276 The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of December 31, 2018 : Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 12,447,355 $ 2.63 6.25 years $ — Exercisable 9,138,544 3.09 5.37 years — Outstanding, vested and expected to vest 12,044,311 2.67 6.16 years — As of March 31, 2019, the Company was authorized to grant options to purchase up to an additional 833,417 shares under the 2010 Equity Incentive Plan, taking into account the annual increase in the number of shares available for issuance under the Company’s 2010 Equity Incentive Plan and the options and restricted stock units (RSUs) granted and forfeited during the three months ended March 31, 2019. Employee Stock Purchase Plan During the three months ended March 31, 2019 and 2018, the Company recorded compensation expense related to its employee stock purchase plan of approximately $6,000 and $10,000 , respectively. Restricted Stock Units A summary of RSU transactions under the plans are as follows: Three Months Ended March 31, 2019 2018 RSUs Weighted Average Grant Date Fair Value RSUs Weighted Average Grant Date Fair Value Restricted stock units outstanding at beginning of period 900,252 $ 1.15 839,285 $ 1.21 Grants 480,400 0.86 1,061,170 1.16 Vested units (889,752 ) 1.15 (839,285 ) 1.21 Forfeitures (10,500 ) 1.16 (21,800 ) 1.16 Restricted stock units outstanding at year end 480,400 0.86 1,039,370 1.16 As of December 31, 2018, there was approximately $352,000 of total unrecognized compensation cost related to outstanding RSUs that will be recognized through the first quarter of 2020. Employee stock-based compensation expense related to RSUs recognized in accordance with ASC 718 was $219,000 and $331,000 for the three months ended March 31, 2019 and 2018, respectively. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES In accordance with ASC 740, Income Taxes, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities at the enacted tax rates in effect for the year in which the differences are expected to reverse. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized. At the end of each interim period, the Company makes its best estimate of the effective tax rate expected to be applicable for the full fiscal year. This estimate reflects, among other items, the Company’s best estimate of operating results and foreign currency exchange rates. The Company’s quarterly income tax rate may differ from its estimated annual effective tax rate because accounting standards require the Company to exclude the actual results of certain entities expected to generate a pretax loss when applying the estimated annual effective tax rate to the Company’s consolidated pretax results in interim periods. In estimating the annual effective tax rate, the Company does not include the estimated impact of unusual and/or infrequent items, including the reversal of valuation allowances, which may cause significant variations in the customary relationship between income tax expense (benefit) and pretax income (loss) in quarterly periods. The income tax expense (benefit) for such unusual and/or infrequent items is recorded in the quarterly period such items are incurred. The Company’s income tax expense and resulting effective tax rate are based upon the respective estimated annual effective tax rates applicable for the respective periods adjusted for the effects of items required to be treated as discrete to the period, including changes in tax laws, changes in estimated exposures for uncertain tax positions and other items. The Company’s effective tax rate for the three months ended March 31, 2019 properly excluded tax benefits associated with year-to-date pre-tax losses generated in the U.S. and the Netherlands. Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company has recorded unrecognized tax benefits related to research and development tax credits. In accordance with ASC 740-10, such attributes are reduced to the amount that is expected to be recognized in the future. The Company has not accrued interest or penalties as no research and development credits have been utilized due to significant net operating losses (NOLs) available. The Company does not expect any decreases to the unrecognized tax benefits within the next twelve months due to any lapses in statute of limitations. Tax years remain subject to examination at the U.S. federal level between 2010 and 2017, and subject to examinations at various state levels between 2005 and 2017. 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. Tax years since 2012 remain subject to examination in the United Kingdom and the Netherlands. Tax years since 2013 remain subject to examination in Germany. 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 net deferred tax asset balance in the U.S. and the Netherlands. 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, 2018, the Company had federal NOL carry-forwards of approximately $122,455,000 and state NOL carry-forwards of approximately $153,333,000 available to reduce future taxable income. The Company’s federal NOL carry-forwards remain fully reserved as of March 31, 2019 . If not utilized, the federal NOL carry-forwards will expire at various dates between 2029 and 2037 and the state NOL carry-forwards will expire at various dates between 2020 and 2037. Sections 382 and 383 of the Internal Revenue Code (IRC) limit the annual use of NOL carry-forwards and tax credit carry-forwards, respectively, following an ownership change. NOL carry-forwards may be subject to annual limitations under IRC Section 382 (Section 382) (or comparable provisions of state law) if certain changes in ownership were to occur. The Company periodically evaluates its NOL carry-forwards and whether certain changes in ownership have occurred that would limit the Company’s ability to utilize a portion of its NOL carry-forwards. If it is determined that significant ownership changes have occurred since the Company generated its NOL carry-forwards, it may be subject to annual limitations on the use of these NOL carry-forwards under Section 382 (or comparable provisions of state law). The Company determined that a Section 382 change in ownership occurred in late 2015. As a result of this change in ownership, the Company estimated that approximately $18.6 million of the Company’s federal NOLs and approximately $382,000 of federal tax credits generated prior to the change in ownership will not be utilized in the future. The Company is currently in the process of refining and finalizing these calculations, and upon finalization, will determine if a write-off is necessary. The reduction to the Company’s NOL deferred tax asset due to the annual Section 382 limitation and the NOL carryforward period would result in an offsetting reduction in valuation allowance recorded against the NOL deferred tax asset. As of December 31, 2018, the Company had cumulative book losses in foreign subsidiaries of $126,648,000 . The Company has not recorded a deferred tax asset for the excess of tax over book basis in the stock of its foreign subsidiaries. The Company anticipates that its foreign subsidiaries will be profitable and have earnings in the future. Once the foreign subsidiaries do have earnings, the Company intends to indefinitely reinvest in its foreign subsidiaries all undistributed earnings of and original investments in such subsidiaries. As a result, the Company has not recorded a deferred tax liability related to excess of book over tax basis in the stock of its foreign subsidiaries in accordance with ASC 740-30-25. |
Segment Information
Segment Information | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment Information | SEGMENT INFORMATION During the three months ended March 31, 2019 and 2018, two customers within the U.S. segment that are large pharmaceutical distributors accounted for 52% and 71% , respectively, of the Company’s consolidated revenues. These same two customers within the U.S. segment accounted for approximately 73% of the Company’s consolidated accounts receivable at both March 31, 2019 and at December 31, 2018. The Company’s chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic and regulatory environment. Each segment is separately managed and is evaluated primarily upon segment loss from operations. Non-cash items including stock-based compensation expense and depreciation and amortization are categorized as Other within the table below. The Company does not report balance sheet information by segment because that information is not reviewed by the Company’s chief operating decision maker. The following table presents a summary of the Company’s reporting segments for the three months ended March 31, 2019 and 2018: Three Months Ended Three Months Ended U.S. International Other Consolidated U.S. International Other Consolidated (In thousands) NET REVENUE $ 6,766 $ 6,124 $ — $ 12,890 $ 6,805 $ 2,825 $ — $ 9,630 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (685 ) (915 ) — (1,600 ) (713 ) (391 ) — (1,104 ) GROSS PROFIT 6,081 5,209 — 11,290 6,092 2,434 — 8,526 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,427 1,170 130 2,727 1,640 950 232 2,822 GENERAL AND ADMINISTRATIVE EXPENSES 1,933 988 472 3,393 2,293 907 655 3,855 SALES AND MARKETING EXPENSES 4,041 1,705 167 5,913 4,371 1,278 320 5,969 DEPRECIATION AND AMORTIZATION — — 652 652 — — 649 649 OPERATING EXPENSES 7,401 3,863 1,421 12,685 8,304 3,135 1,856 13,295 SEGMENT (LOSS) INCOME FROM OPERATIONS (1,320 ) 1,346 (1,421 ) (1,395 ) (2,212 ) (701 ) (1,856 ) (4,769 ) OTHER INCOME AND EXPENSES, NET — — (1,297 ) (1,297 ) — — (2,915 ) (2,915 ) NET LOSS BEFORE TAXES $ (2,692 ) $ (7,684 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Basis of Presentation | BASIS OF PRESENTATION The Company has prepared the accompanying unaudited interim condensed consolidated financial statements and notes thereto (Interim Financial Statements) in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for interim financial information, the instructions to Form 10-Q and Article 10-01 of Regulation S-X of the Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of the Company’s management, the accompanying interim financial statements reflect all adjustments, which include normal recurring adjustments, necessary to present fairly the Company’s interim financial information. The accompanying interim financial statements and related notes should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2018 and related notes included in the Company’s Annual Report on Form 10-K, which was filed with the SEC on February 25, 2019. The financial results for any interim period are not necessarily indicative of the expected financial results for the full year. |
Prior period reclassification | Prior period reclassification An immaterial reclassification of prior period amounts related to revenue and cost of goods sold, excluding depreciation and amortization has been made to conform to the current period presentation. This reclassification did not have any impact on gross profit, net loss from operations or net loss. |
Recent Accounting Pronouncements and Adoption of New Accounting Standards | Recent Accounting Pronouncements From time to time, the Financial Accounting Standards Board (FASB) or other standard setting bodies issue new accounting pronouncements that we adopt as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption. Adoption of New Accounting Standards In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842) , to increase transparency and comparability among organizations for lease recognition and disclosure. ASU 2016-02 requires lessees to recognize lease assets and lease liabilities on the balance sheet, while recognizing expenses on the income statements in a manner similar to current guidance. ASU 2016-02 became effective for fiscal years and interim periods for the Company in the first quarter of 2019. ASU 2016-02 requires that leases be recognized and measured as of the earliest period presented, using a modified retrospective approach, with all periods presented being adjusted and presented under the new standard. In July 2018, the FASB issued ASU 2018-11, Leases (ASC 842) : Targeted Improvements, which provides companies an optional adoption method to ASU 2016-02 whereby a company does not have to adjust comparative period financial statements for the new standard. The Company adopted this ASU on January 1, 2019 and did not restate comparative periods. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company also made an accounting policy election to not recognize right of use assets and liabilities for leases with a term of 12 months or less, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. See Note 5 for expanded disclosures. In February 2018, the FASB issued ASU 2018-02, Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income , to allow reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. Upon adoption of the ASU, entities are required to describe the accounting policy for releasing income tax effects from accumulated other comprehensive income. The Company adopted this standard on January 1, 2019. The adoption of this guidance did not have a material impact on the Company’s financial statements. In June 2018, the FASB issued ASU No. 2018-07, Stock-based Compensation: Improvements to Nonemployee Share-based Payment Accounting , which amends the existing accounting standards for share-based payments to nonemployees. This ASU aligns much of the guidance on measuring and classifying nonemployee awards with that of awards to employees. Under the new guidance, the measurement of nonemployee equity awards is fixed on the grant date. This ASU became effective on January 1, 2019, and the Company adopted it at that time. Entities will apply the ASU by recognizing a cumulative-effect adjustment to retained earnings as of the beginning of the annual period of adoption. The adoption of this guidance did not have a material impact on the Company’s financial statements. Accounting Standards Issued but Not Yet Effective In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit losses (Topic 326): Measurement of Credit Losses on Financial Instruments . This ASU replaces the current incurred loss impairment methodology for financial assets measured at amortized cost with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information, including forecasted information, to develop credit loss estimates. The standard is effective for annual periods beginning after December 15, 2019, including interim periods within those annual periods, with early adoption available. The Company is in the process of determining the effect that the adoption will have on its financial statements. |
Revenue Recognition | Net Revenue The Company sells its products to major pharmaceutical distributors, pharmacies, hospitals and wholesalers (collectively, its Customers). In addition to distribution agreements with Customers, the Company enters into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. All of the Company’s current contracts have a single performance obligation, as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and is, therefore, not distinct. Currently, all of the Company’s revenue is derived from product sales. The Company recognizes revenues from product sales at a point in time when the Customer obtains control, typically upon delivery. The Company accrues for fulfillment costs when the related revenue is recognized. Taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues. As of March 31, 2019, the Company had received a total of $1,000,000 of payments that it has not recognized as revenue based on the Company’s analysis in connection with Topic 606. These deferred revenues are included as a component of other non-current liabilities on the Company’s balance sheets. Estimates of Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for reserves related to statutory rebates to State Medicaid and other government agencies; commercial rebates and fees to Managed Care Organizations (MCOs), Group Purchasing Organizations (GPOs), distributors, and specialty pharmacies; product returns; sales discounts (including trade discounts); distributor costs; wholesaler chargebacks; and allowances for patient assistance programs relating to the Company’s sales of its products. These reserves are based on estimates of the amounts earned or to be claimed on the related sales. Management’s estimates take into consideration historical experience, current contractual and statutory requirements, specific known market events and trends, industry data, and Customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the contract. The amount of variable consideration included in the net sales price is limited to the amount that is probable not to result in a significant reversal in the amount of the cumulative revenue recognized in a future period. If actual results vary, the Company may adjust these estimates, which could have an effect on earnings in the period of adjustment. Consideration Payable to Customers Distribution service fees are payments issued to distributors for compliance with various contractually-defined inventory management practices or services provided to support patient access to a product. Distribution service fees reserves are based on the terms of each individual contract and are classified within accrued expenses and are recorded as a reduction of revenue. Product Returns The Company’s policies provide for product returns in the following circumstances: (a) expiration of shelf life on certain products; (b) product damaged while in the Customer’s possession; and (c) following product recalls. Generally, returns for expired product are accepted three months before and up to one year after the expiration date of the related product, and the related product is destroyed after it is returned. The Company may either refund the sales price paid by the Customer by issuing a credit or exchanging the returned product for replacement inventory. The Company typically does not provide cash refunds. The Company estimates the proportion of recorded revenue that will result in a return by considering relevant factors, including historical returns experience, the estimated level of inventory in the distribution channel, the shelf life of products and product recalls, if any. The estimation process for product returns involves, in each case, a number of interrelating assumptions, which vary for each Customer. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue from product sales in the period the related revenue is recognized, and because this returned product cannot be resold, there is no corresponding asset for product returns. To date, product returns have been minimal. Other Revenue The Company enters into agreements in which it licenses certain rights to its products to partner companies that act as distributors. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply services the Company provides; and a revenue share on net sales of licensed products. Each of these payments is recognized as other revenues. As part of the accounting for these arrangements, the Company must develop estimates that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. Performance obligations are promises in a contract to transfer a distinct good or service to the Customer, and the Company recognizes revenue when, or as, performance obligations are satisfied. The Company uses key assumptions to determine the stand-alone selling price; these assumptions may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical, regulatory and commercial success. Certain of these agreements include consideration in the form of milestone payments. At the inception of each arrangement that includes milestone payments, the Company evaluates the recognition of milestone payments. Typically, milestone payments are associated with events that are not entirely within the control of the Company or the licensee, such as regulatory approvals; are included in the transaction price; and are subject to a constraint until it is probable that there will not be a significant revenue reversal, typically upon achievement of the milestone. At the end of each reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Customer Payment Obligations The Company receives payments from its Customers based on billing schedules established in each contract, which vary across the Company’s locations, but generally range between 30 to 120 days. Occasionally, the timing of receipt of payment for the Company’s international Customers can be extended. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation is that the Customer will pay for the product or services in one year or less of receiving those products or services. |
Leases | The Company evaluates all of its contracts to determine whether it is or contains a lease at inception. The Company reviews its contracts for options to extend, terminate or purchase any right of use assets and accounts for these, as applicable, at inception of the contract. The Company elected the transition package of three practical expedients permitted within the standard. In accordance with the package of practical expedients, the Company did not reassess initial direct costs, lease classification, or whether its contracts contain or are leases. The Company made an accounting policy election not to recognize right of use assets and liabilities for leases with a term of 12 months or less, or those that do not meet the Company’s capitalization threshold, unless the leases include options to renew or purchase the underlying asset that are reasonably certain to be exercised. Lease costs associated with those leases are recognized as incurred. The Company has also chosen the practical expedient that allows it to combine lease and non-lease components as a single lease component. Lease renewal options are not recognized as part of the lease liability until the Company determines it is reasonably certain it will exercise any applicable renewal options. The Company has determined it is not reasonably certain it will exercise any applicable renewal options. The Company has not recorded any liability for renewal options in these Interim Financial Statements. The useful lives of leased assets as well as leasehold improvements, if any, are limited by the expected lease term. |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Summary of Supplemental Balance Sheet Lease Information | Supplemental balance sheet information as of March 31, 2019 for the Company’s operating leases is as follows: (in thousands) NON-CURRENT ASSETS: Right of use assets, net $ 775 Total lease assets $ 775 CURRENT LIABILITIES: Accrued expenses (Note 9) $ 433 NON-CURRENT LIABILITIES: Other non-current liabilities 560 Total lease liabilities $ 993 Supplemental balance sheet information as of March 31, 2019 and December 31, 2018 for the Company’s finance leases are as follows: March 31, 2019 December 31, 2018 (In thousands) NON-CURRENT ASSETS: Property and equipment, net $ 602 $ 615 Total lease assets $ 602 $ 615 CURRENT LIABILITIES: Finance lease obligations $ 253 $ 236 NON-CURRENT LIABILITIES: Finance lease obligations — less current portion 241 305 Total lease liabilities $ 494 $ 541 |
Schedule of Future Minimum Operating Lease Payments | As of March 31, 2019, a schedule of maturity of lease liabilities under all of the Company’s operating leases is as follows: Years Ending December 31 (In thousands) 2019 (remaining) $ 394 2020 412 2021 299 Total 1,105 Less amount representing interest (112 ) Present value of minimum lease payments 993 Less current portion (433 ) Non-current portion $ 560 |
Schedule of Future Minimun Finance Lease Payments | As of March 31, 2019, a schedule of maturity of lease liabilities under finance leases, together with the present value of minimum lease payments, is as follows: Years Ending December 31 (In thousands) 2019 (remaining) $ 211 2020 253 2021 65 2022 3 Total 532 Less amount representing interest (38 ) Present value of minimum lease payments 494 Less current portion (253 ) Non-current portion $ 241 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory consisted of the following: March 31, 2019 December 31, 2018 (In thousands) Component parts (1) $ 413 $ 129 Work-in-process (2) 111 924 Finished goods 1,336 1,352 Total Inventory $ 1,860 $ 2,405 (1) Component parts inventory consists of manufactured components of the ILUVIEN applicator. (2) Work-in-process consists of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing or stability testing as required by U.S. or EEA regulatory authorities. |
Intangible Asset (Tables)
Intangible Asset (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Intangible Assets, Net (Excluding Goodwill) [Abstract] | |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | The estimated future amortization expense as of March 31, 2019 for the remaining periods in the next five years and thereafter is as follows: Years Ending December 31 (In thousands) 2019 $ 1,462 2020 1,946 2021 1,940 2022 1,940 2023 1,940 Thereafter 7,017 Total $ 16,245 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following: March 31, 2019 December 31, 2018 (In thousands) Accrued clinical investigator expenses $ 840 $ 781 Accrued compensation expenses 1,212 1,427 Accrued rebate, chargeback and other revenue reserves 385 346 Accrued lease liabilities (Note 5) 433 — Other accrued expenses 248 1,089 Total accrued expenses $ 3,118 $ 3,643 |
Earnings (Loss) Per Share (EP_2
Earnings (Loss) Per Share (EPS) (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because they were either classified as participating or would have been anti-dilutive, were as follows: Three Months Ended 2019 2018 Series A convertible preferred stock 9,022,556 9,022,556 Series B convertible preferred stock — 8,416,251 Series C convertible preferred stock 10,150,000 — Common stock warrants 1,795,663 1,795,663 Stock options 13,407,536 12,343,820 Restricted stock units 480,400 1,039,370 Total 34,856,155 32,617,660 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Compensation, Restricted Stock and Restricted Stock Units Activity [Table Text Block] | A summary of RSU transactions under the plans are as follows: Three Months Ended March 31, 2019 2018 RSUs Weighted Average Grant Date Fair Value RSUs Weighted Average Grant Date Fair Value Restricted stock units outstanding at beginning of period 900,252 $ 1.15 839,285 $ 1.21 Grants 480,400 0.86 1,061,170 1.16 Vested units (889,752 ) 1.15 (839,285 ) 1.21 Forfeitures (10,500 ) 1.16 (21,800 ) 1.16 Restricted stock units outstanding at year end 480,400 0.86 1,039,370 1.16 |
Summary of stock option transactions | The following table presents a summary of stock option activity for the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Options Weighted Average Exercise Price Options Weighted Average Exercise Price Options outstanding at beginning of period 12,447,355 $ 2.63 11,595,510 $ 2.90 Grants 1,174,750 0.87 1,233,000 1.16 Forfeitures (214,569 ) 1.99 (483,127 ) 2.34 Exercises — — (1,563 ) 1.06 Options outstanding at period end 13,407,536 2.48 12,343,820 2.75 Options exercisable at period end 9,536,065 3.02 8,168,883 3.24 Weighted average per share fair value of options granted during the period $ 0.55 $ 0.78 |
Summary of additional stock option transactions | The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of March 31, 2019 : Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 13,407,536 $ 2.48 6.29 years $ 321 Exercisable 9,536,065 3.02 5.24 years 53 Outstanding, vested and expected to vest 12,885,031 2.54 6.17 years 276 The following table provides additional information related to outstanding stock options, exercisable stock options and stock options that were expected to vest as of December 31, 2018 : Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In thousands) Outstanding 12,447,355 $ 2.63 6.25 years $ — Exercisable 9,138,544 3.09 5.37 years — Outstanding, vested and expected to vest 12,044,311 2.67 6.16 years — |
Segment Information (Tables)
Segment Information (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Schedule of Reporting Segments | The following table presents a summary of the Company’s reporting segments for the three months ended March 31, 2019 and 2018: Three Months Ended Three Months Ended U.S. International Other Consolidated U.S. International Other Consolidated (In thousands) NET REVENUE $ 6,766 $ 6,124 $ — $ 12,890 $ 6,805 $ 2,825 $ — $ 9,630 COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION (685 ) (915 ) — (1,600 ) (713 ) (391 ) — (1,104 ) GROSS PROFIT 6,081 5,209 — 11,290 6,092 2,434 — 8,526 RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES 1,427 1,170 130 2,727 1,640 950 232 2,822 GENERAL AND ADMINISTRATIVE EXPENSES 1,933 988 472 3,393 2,293 907 655 3,855 SALES AND MARKETING EXPENSES 4,041 1,705 167 5,913 4,371 1,278 320 5,969 DEPRECIATION AND AMORTIZATION — — 652 652 — — 649 649 OPERATING EXPENSES 7,401 3,863 1,421 12,685 8,304 3,135 1,856 13,295 SEGMENT (LOSS) INCOME FROM OPERATIONS (1,320 ) 1,346 (1,421 ) (1,395 ) (2,212 ) (701 ) (1,856 ) (4,769 ) OTHER INCOME AND EXPENSES, NET — — (1,297 ) (1,297 ) — — (2,915 ) (2,915 ) NET LOSS BEFORE TAXES $ (2,692 ) $ (7,684 ) |
Nature of Operations (Detail)
Nature of Operations (Detail) - ILUVIEN | 1 Months Ended | 3 Months Ended |
Dec. 31, 2017country | Mar. 31, 2019Patient | |
Nature Of Operations [Line Items] | ||
Post-authorization open study period (in years) | 5 years | |
Planned drug study, number of patients | 800 | |
Number of patients | 562 | |
Number of countries in which company plans to file application for new indication | country | 17 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Accounting Policies [Abstract] | ||
Research and development expense | $ 197 | $ 104 |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) $ in Millions | Mar. 31, 2019USD ($) |
Revenue from Contract with Customer [Abstract] | |
Milestone payments not recognized as revenue, noncurrent | $ 1 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Lessee, Lease, Description [Line Items] | ||
Operating lease cost | $ 123,000 | |
Cash paid for leases | $ 100,000 | |
Weighted average remaining lease term | 2 years 1 month | |
Weighted average discount rate, leases | 10.20% | |
Finance lease cost | $ 9,000 | $ 6,000 |
Finance lease depreciation | 76,000 | $ 49,000 |
Finance lease, interest payment on liability and principal payments | 100,000 | |
Right-of-use asset obtained in exchange for finance lease liability | $ 64,000 | |
Finance lease, weighted average remaining term | 1 year 10 months | |
Finance lease, weighted average discount rate | 7.00% | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 1 year | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Lease renewal term | 7 years |
Leases - Operating Lease Supple
Leases - Operating Lease Supplemental Balance Sheet Information (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
NON-CURRENT ASSETS: | ||
Operating lease, right-of-use asset | $ 775,000 | |
Finance lease, right-of-use asset | 602,000 | $ 615,000 |
CURRENT LIABILITIES: | ||
Operating lease liability, current | 433,000 | |
Finance lease obligations | 253,000 | 236,000 |
NON-CURRENT LIABILITIES: | ||
Operating lease liability, noncurrent | 560,000 | |
Finance lease obligations — less current portion | 241,000 | 305,000 |
Total operating lease liabilities | 993,000 | |
Total finance lease liabilities | $ 494,000 | $ 541,000 |
Leases - Future Minimum Operati
Leases - Future Minimum Operating Lease Payments (Details) | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 394,000 |
2020 | 412,000 |
2021 | 299,000 |
Total | 1,105,000 |
Less amount representing interest | (112,000) |
Total operating lease liabilities | 993,000 |
Operating lease liability, current | (433,000) |
Non-current portion | $ 560,000 |
Leases - Future Minimum Finance
Leases - Future Minimum Finance Lease Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
2019 | $ 211 | |
2020 | 253 | |
2021 | 65 | |
2022 | 3 | |
Total | 532 | |
Less amount representing interest | (38) | |
Total finance lease liabilities | 494 | $ 541 |
Less current portion | (253) | (236) |
Non-current portion | $ 241 | $ 305 |
Going Concern (Detail)
Going Concern (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 | Jan. 05, 2018 |
Debt Instrument [Line Items] | |||
Accumulated deficit | $ 379,890,000 | $ 377,127,000 | |
Cash and cash equivalents | $ 13,094,000 | $ 13,043,000 | |
2018 Loan Agreement | Solar Capital | |||
Debt Instrument [Line Items] | |||
Debt instrument, face amount | $ 40,000,000 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory | ||
Component parts | $ 413 | $ 129 |
Work-in-process | 111 | 924 |
Finished goods | 1,336 | 1,352 |
Total Inventory | $ 1,860 | $ 2,405 |
Intangible Asset - Narrative (D
Intangible Asset - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2014 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||||
Net intangible assets | $ 16,245 | $ 16,723 | ||
License | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Gross intangible assets | $ 25,000 | |||
Useful life (in years) | 13 years | |||
Amortization of intangible assets | $ 478 | $ 478 | ||
Net intangible assets | $ 16,245 | |||
pSivida | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Milestone payment after the first product approved by the FDA | $ 25,000 |
Intangible Asset - Future Amort
Intangible Asset - Future Amortization (Details) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
Total | $ 16,245 | $ 16,723 |
License | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | ||
2019 | 1,462 | |
2020 | 1,946 | |
2021 | 1,940 | |
2022 | 1,940 | |
2023 | 1,940 | |
Thereafter | 7,017 | |
Total | $ 16,245 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Detail) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accrued clinical investigator expenses | $ 840,000 | $ 781,000 |
Accrued compensation expenses | 1,212,000 | 1,427,000 |
Accrued rebate, chargeback and other revenue reserves | 385,000 | 346,000 |
Accrued lease liabilities (Note 5) | 433,000 | |
Other accrued expenses | 248,000 | 1,089,000 |
Total accrued expenses | $ 3,118,000 | $ 3,643,000 |
License Agreements (Details)
License Agreements (Details) - USD ($) | Dec. 12, 2018 | Jul. 10, 2017 | Jul. 01, 2017 | Mar. 31, 2019 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2008 | Jun. 30, 2017 |
Collaborative Arrangement, Co-promotion | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Share of net profits | 20.00% | |||||||
Share of any lump sum milestone payments received from sub licensee of Iluvien | 33.00% | |||||||
Percentage of recovery of commercialization cost | 20.00% | |||||||
Collaborative arrangement, royalty payable on net revenue, percentage | 2.00% | |||||||
Collaborative arrangement, increase in royalty payable on net revenue | 6.00% | |||||||
Collaborative arrangement, royalty payable on net revenue over threshold, percentage | 2.00% | |||||||
Collaborative arrangement, royalty payable on net revenue, revenue threshold | $ 75,000,000 | |||||||
Collaborative arrangement, forgiveness of future offset | 10,000,000 | |||||||
Collaborative agreement, capped future offset amount | $ 25,000,000 | |||||||
Collaborative arrangement, forgiveness of future offset, additional amount | $ 5,000,000 | |||||||
Reduction in royalty on net revenues up to threshold, first two years, percentage | 4.00% | |||||||
Reduction in royalty on net revenues in excess of threshold, first two years, percentage | 5.00% | 8.00% | ||||||
Reduction in royalty on net revenues up to threshold, third year and thereafter, percentage | 5.20% | |||||||
Reduction in royalty on net revenues in excess of threshold, third year and thereafter, percentage | 6.80% | |||||||
Minimum days to require to revert license in case of breach of contract | 30 days | |||||||
Maximum days to require to revert license in case of breach of contract | 90 days | |||||||
Bankruptcy proceedings period petitions for bankruptcy filed | 60 days | |||||||
New Collaboration Agreement, 2017 Second Amended | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Royalty expense | $ 516,000 | $ 193,000 | ||||||
Royalty future offset | $ 25,000,000 | |||||||
Maximum | Collaborative Arrangement, Co-promotion | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Recoverable amount to offset future royalty payments | $ 15,000,000 | $ 9,820,000 | $ 9,820,000 |
Loan Agreements (Details)
Loan Agreements (Details) - USD ($) | Jan. 05, 2018 | Oct. 20, 2016 | Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2016 | Dec. 31, 2014 | Apr. 30, 2014 |
Debt Instrument [Line Items] | ||||||||
Loss on extinguishment of debt | $ 0 | $ 1,766,000 | ||||||
Solar Capital Ltd. | Twenty Eighteen Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 40,000,000 | |||||||
Debt instrument, fee amount | $ 1,800,000 | |||||||
Interest only payments, term | 30 months | |||||||
Principal and interest payments, term | 24 months | |||||||
Debt instrument, interest only payments, additional term | 6 months | |||||||
Principal and interest payments, additional term | 18 months | |||||||
Payments for brokerage fees | $ 400,000 | |||||||
Debt instrument, fee amount if interest only period is extended | $ 2,000,000 | |||||||
Debt instrument, interest only payments, extension term | 36 months | |||||||
Debt instrument, incremental prepayments of outstanding balance | $ 10,000,000 | |||||||
Debt instrument, additional exit fee | $ 1,000,000 | |||||||
Debt instrument, covenant, voting interests, percentage | 65.00% | |||||||
Solar Capital Ltd. | Twenty Eighteen Term Loan | London Interbank Offered Rate (LIBOR) | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, basis spread on variable rate | 7.65% | |||||||
Solar Capital Ltd. | Twenty Eighteen Term Loan | Tranche One | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, principal prepayment fee percentage, first 12 months | 2.00% | |||||||
Solar Capital Ltd. | Twenty Eighteen Term Loan | Tranche Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, principal prepayment fee percentage, greater than 12 months, less than 24 months | 1.00% | |||||||
Solar Capital Ltd. | Twenty Eighteen Term Loan | Tranche Three | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, principal prepayment fee percentage, greater than 24 months | 0.50% | |||||||
Debt instrument, number of days before maturity date | 30 days | |||||||
Alimera Sciences Limited (Limited) | Hercules Technology Growth Capital, Inc. | Twenty Fourteen Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Line of credit facility, maximum borrowing capacity | $ 35,000,000 | |||||||
Debt instrument, interest rate, effective percentage | 12.00% | |||||||
Alimera Sciences Limited (Limited) | Hercules Technology Growth Capital, Inc. | Fourth Loan Amendment | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, interest rate, stated percentage | 11.00% | |||||||
Debit instrument, payment-in-kind interest rate | 1.00% | |||||||
Debt instrument, prepayment fee percentage, greater than 12 months, less than 24 months | 2.00% | |||||||
Repayments of debt | $ 709,000 | |||||||
Debt instrument, fee amount | $ 1,400,000 | |||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 458,716 | |||||||
Class of warrant or right, exercise price of warrants or rights (usd per share) | $ 1.09 | |||||||
Loss on extinguishment of debt | $ 1,766,000 | |||||||
Alimera Sciences Limited (Limited) | Hercules Technology Growth Capital, Inc. | Fourth Loan Amendment | Prime Rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, basis spread on variable rate | 11.00% | |||||||
Debt instrument, basis spread on variable rate, reduction | 3.50% | |||||||
Alimera Sciences Limited (Limited) | Solar Capital | 2018 Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, interest rate, stated percentage | 10.10% | |||||||
Alimera Sciences, Inc.(Company) | Hercules Technology Growth Capital, Inc. | Twenty Fourteen Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 285,016 | |||||||
Class of warrant or right, exercise price of warrants or rights (usd per share) | $ 6.14 | |||||||
Alimera Sciences, Inc.(Company) | Hercules Technology Growth Capital, Inc. | July 2016 Waiver | ||||||||
Debt Instrument [Line Items] | ||||||||
Class of warrant or right, number of securities called by warrants or rights (in shares) | 1,258,993 | |||||||
Class of warrant or right, exercise price of warrants or rights (usd per share) | $ 1.39 | |||||||
Exit Fee Agreement | Solar Capital Ltd. | Twenty Eighteen Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, term | 10 years | |||||||
Debt instrument, exit fee | $ 2,000,000 | |||||||
ILUVIEN | Solar Capital Ltd. | Twenty Eighteen Term Loan | Tranche One | ||||||||
Debt Instrument [Line Items] | ||||||||
Net revenue | 80,000,000 | |||||||
ILUVIEN | Solar Capital Ltd. | Twenty Eighteen Term Loan | Tranche Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Net revenue | $ 100,000,000 |
Earnings (Loss) Per Share (EP_3
Earnings (Loss) Per Share (EPS) - Antidilutive Securities Excluded from the Computation of Diluted Earnings Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 34,856,155 | 32,617,660 |
Series A convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 9,022,556 | 9,022,556 |
Series B convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 0 | 8,416,251 |
Series C convertible preferred stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 10,150,000 | 0 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 13,407,536 | 12,343,820 |
Restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 480,400 | 1,039,370 |
Common Stock | Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,795,663 | 1,795,663 |
Preferred Stock (Detail)
Preferred Stock (Detail) - USD ($) | Sep. 04, 2018 | Dec. 12, 2014 | Oct. 02, 2012 | Mar. 31, 2019 | Sep. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2014 | Dec. 31, 2018 |
Conversion of Stock [Line Items] | ||||||||
Issuance of common stock, net of issuance costs | $ 0 | $ 0 | ||||||
Preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 | ||||||
Legal expenses incurred due to preferred stock conversion | $ 122,000 | |||||||
Gain on extinguishment of preferred stock | $ 38,330,000 | |||||||
Series A convertible preferred stock | ||||||||
Conversion of Stock [Line Items] | ||||||||
Number of preferred stock and warrants (in shares) | 1,000,000 | |||||||
Warrants to purchase additional shares (in shares) | 300,000 | |||||||
Gross proceeds under securities purchase agreement | $ 40,000,000 | |||||||
Estimated total stock issuance cost | $ 560,000 | |||||||
Conversion rate of Series A Convertible Preferred Stock issued upon exercise of warrants into common stock (usd per share) | $ 40 | |||||||
Initial conversion price (usd per share) | 2.66 | |||||||
Preferred stock converted to common stock per share (usd per share) | $ 10 | |||||||
Proceeds from issuance of preferred stock | $ 30,000,000 | |||||||
Convertible securities converted (in shares) | 400,000 | |||||||
Preferred stock, shares issued (in shares) | 600,000 | 600,000 | ||||||
Preferred stock, shares outstanding (in shares) | 600,000 | 600,000 | ||||||
Preferred stock, liquidation preference | $ 24,000,000 | $ 24,000,000 | ||||||
Preferred stock, fair value | $ 19,227,000 | $ 19,227,000 | ||||||
Common Stock | ||||||||
Conversion of Stock [Line Items] | ||||||||
Common stock issued upon conversion of convertible securities (in shares) | 6,015,037 | |||||||
Series B convertible preferred stock | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 8,291.873 | |||||||
Share purchase price of shares issued (usd per share) | $ 6,030 | |||||||
Issuance of common stock, net of issuance costs | $ 50,000,000 | |||||||
Payment of stock issuance cost | $ 432,000 | |||||||
Preferred stock, shares outstanding (in shares) | 8,416 | |||||||
Series B convertible preferred stock | Over-Allotment Option | ||||||||
Conversion of Stock [Line Items] | ||||||||
Issuance of stock (in shares) | 124.378 | |||||||
Series C convertible preferred stock | ||||||||
Conversion of Stock [Line Items] | ||||||||
Preferred stock, shares issued (in shares) | 10,150 | 10,150 | ||||||
Issuance of stock (in shares) | 10,150 | |||||||
Issuance of common stock, net of issuance costs | $ 10,150,000 | |||||||
Payment of stock issuance cost | $ 122,000 | |||||||
Shares issued upon conversion (in shares) | 10,150,000 | |||||||
Ownership interest after conversion (percent) | 9.98% | |||||||
Preferred stock, shares outstanding (in shares) | 10,150 | 10,150 | ||||||
Preferred stock, par value (usd per share) | $ 0.01 | |||||||
Conversion price per share (USD per share) | $ 1 | |||||||
Preferred stock, liquidation preference | $ 10,150,000 | $ 10,150,000 | $ 10,150,000 | |||||
Preferred stock, fair value | $ 11,117,000 | $ 11,117,000 | ||||||
Estimate of Fair Value Measurement | Series C convertible preferred stock | ||||||||
Conversion of Stock [Line Items] | ||||||||
Preferred stock, fair value | $ 11,239,000 |
Stock Incentive Plans - Narrati
Stock Incentive Plans - Narrative (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average contractual term | 5 years 2 months 25 days | 5 years 4 months 15 days | |
Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 545 | $ 866 | |
Share-based compensation not yet recognized | $ 2,964 | ||
Weighted average contractual term | 2 years 6 months 7 days | ||
Equity Incentive Plan 2010 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Awards granted in period (in shares) | 833,417 | ||
Employee Stock | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 6 | 10 | |
Restricted stock units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation expense | $ 219 | $ 331 | |
Awards granted in period (in shares) | 480,400 | 1,061,170 | |
Unrecognized share based compensation expense | $ 352 |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Stock Option Transactions (Detail) - $ / shares | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Options | |||
Options outstanding at beginning of period (in shares) | 12,447,355 | 11,595,510 | |
Grants (in shares) | 1,174,750 | 1,233,000 | |
Forfeitures (in shares) | (214,569) | (483,127) | |
Exercises (in shares) | 0 | (1,563) | |
Options outstanding at year end (in shares) | 13,407,536 | 12,343,820 | |
Options exercisable at year end (in shares) | 9,536,065 | 8,168,883 | 9,138,544 |
Weighted average per share fair value of options granted during the period (in dollars per share) | $ 0.55 | $ 0.78 | |
Weighted Average Exercise Price | |||
Options outstanding at beginning of period (usd per share) | 2.63 | 2.90 | |
Grants (usd per share) | 0.87 | 1.16 | |
Forfeitures (usd per share) | 1.99 | 2.34 | |
Exercises (usd per share) | 0 | 1.06 | |
Options outstanding at year end (usd per share) | 2.48 | 2.75 | |
Options exercisable at year end (usd per share) | $ 3.02 | $ 3.24 | $ 3.09 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Stock Option Transactions (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | |
Outstanding Stock Options | ||||
Outstanding, shares (in shares) | 13,407,536 | 12,447,355 | 12,343,820 | 11,595,510 |
Outstanding, weighted average exercise price (usd per share) | $ 2.48 | $ 2.63 | $ 2.75 | $ 2.90 |
Outstanding, weighted average remaining contractual term | 6 years 3 months 15 days | 6 years 3 months 1 day | ||
Outstanding, aggregate intrinsic value | $ 321 | $ 0 | ||
Exercisable Stock Options | ||||
Exercisable, shares (in shares) | 9,536,065 | 9,138,544 | 8,168,883 | |
Exercisable, weighted average exercise price (usd per share) | $ 3.02 | $ 3.09 | $ 3.24 | |
Exercisable, weighted average remaining contractual term | 5 years 2 months 25 days | 5 years 4 months 15 days | ||
Exercisable, aggregate intrinsic value | $ 53 | $ 0 | ||
Exercisable and expected to vest | ||||
Outstanding, vested and expected to vest, shares (in shares) | 12,885,031 | 12,044,311 | ||
Outstanding, vested and expected to vest, weighted average exercise price (usd per share) | $ 2.54 | $ 2.67 | ||
Outstanding, vested and expected to vest, weighted average remaining contractual term | 6 years 2 months 1 day | 6 years 1 month 28 days | ||
Outstanding, vested and expected to vest, aggregate intrinsic value | $ 276 | $ 0 |
Stock Incentive Plans - Summa_2
Stock Incentive Plans - Summary of RSU Transactions (Details) - Restricted stock units - $ / shares | 3 Months Ended | |||
Mar. 31, 2019 | Mar. 31, 2018 | Mar. 31, 2019 | Mar. 31, 2018 | |
RSUs | ||||
Restricted stock units outstanding at beginning of period (in shares) | 900,252 | 839,285 | ||
Grants (in shares) | 480,400 | 1,061,170 | ||
Vested units (in shares) | (889,752) | (839,285) | ||
Forfeitures (in shares) | (10,500) | (21,800) | ||
Restricted stock units outstanding at year end (in shares) | 480,400 | 1,039,370 | ||
Weighted Average Grant Date Fair Value | ||||
Restricted stock units outstanding at beginning of period (usd per share) | $ 1.15 | $ 1.21 | ||
Grants (usd per share) | 0.86 | 1.16 | ||
Vested units (usd per share) | 1.15 | 1.21 | ||
Forfeitures (usd per share) | 1.16 | 1.16 | ||
Restricted stock units outstanding at year end (usd per share) | $ 1.15 | $ 1.21 | $ 0.86 | $ 1.16 |
Income Taxes (Detail)
Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 31, 2019 | Dec. 31, 2018 | |
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, valuation allowance | $ 18,600 | ||
Federal tax credits, unable to be utilized post change in ownership | $ 382 | ||
Cumulative book losses in foreign subsidiaries | $ 126,648 | ||
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forwards | $ 122,455 | 122,455 | |
State | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry-forwards | $ 153,333 |
Segment Information (Details)
Segment Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Segment Reporting Information [Line Items] | |||
NET REVENUE | $ 12,890 | $ 9,630 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,600) | (1,104) | |
GROSS PROFIT | 11,290 | 8,526 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 2,727 | 2,822 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 3,393 | 3,855 | |
SALES AND MARKETING EXPENSES | 5,913 | 5,969 | |
DEPRECIATION AND AMORTIZATION | 652 | 649 | |
OPERATING EXPENSES | 12,685 | 13,295 | |
NET LOSS FROM OPERATIONS | (1,395) | (4,769) | |
OTHER INCOME AND EXPENSES, NET | (1,297) | (2,915) | |
NET LOSS BEFORE TAXES | $ (2,692) | $ (7,684) | |
Customer Concentration Risk | Revenues | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 52.00% | 71.00% | |
Customer Concentration Risk | Accounts Receivable | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 73.00% | 73.00% | |
United States Segment | |||
Segment Reporting Information [Line Items] | |||
NET REVENUE | $ 6,766 | $ 6,805 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (685) | (713) | |
GROSS PROFIT | 6,081 | 6,092 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,427 | 1,640 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 1,933 | 2,293 | |
SALES AND MARKETING EXPENSES | 4,041 | 4,371 | |
DEPRECIATION AND AMORTIZATION | 0 | 0 | |
OPERATING EXPENSES | 7,401 | 8,304 | |
NET LOSS FROM OPERATIONS | (1,320) | (2,212) | |
International Segment | |||
Segment Reporting Information [Line Items] | |||
NET REVENUE | 6,124 | 2,825 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (915) | (391) | |
GROSS PROFIT | 5,209 | 2,434 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 1,170 | 950 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 988 | 907 | |
SALES AND MARKETING EXPENSES | 1,705 | 1,278 | |
DEPRECIATION AND AMORTIZATION | 0 | 0 | |
OPERATING EXPENSES | 3,863 | 3,135 | |
NET LOSS FROM OPERATIONS | 1,346 | (701) | |
Other Segments | |||
Segment Reporting Information [Line Items] | |||
NET REVENUE | 0 | 0 | |
COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | 0 | 0 | |
GROSS PROFIT | 0 | 0 | |
RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 130 | 232 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 472 | 655 | |
SALES AND MARKETING EXPENSES | 167 | 320 | |
DEPRECIATION AND AMORTIZATION | 652 | 649 | |
OPERATING EXPENSES | 1,421 | 1,856 | |
NET LOSS FROM OPERATIONS | (1,421) | (1,856) | |
OTHER INCOME AND EXPENSES, NET | $ (1,297) | $ (2,915) |