Full Press Release Details
ALIMERA SCIENCES, INC.
INDEX TO FINANCIAL STATEMENTS
| Page | |
| Report of Independent Registered Public Accounting Firm | 2 |
| Consolidated Financial Statements as of December 31, 2014 and 2013 and for the years ended December 31, 2014 and 2013: | |
| Consolidated Balance Sheets | 3 |
| Consolidated Statements of Operations | 4 |
| Consolidated Statements of Comprehensive Loss | 5 |
| Consolidated Statements of Changes in Stockholders' (Deficit) Equity | 6 |
| Consolidated Statements of Cash Flows | 7 |
| Notes to Consolidated Financial Statements | 8 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders
Alimera Sciences, Inc.
We have audited the accompanying consolidated balance sheets of Alimera Sciences, Inc. (a Delaware corporation) and subsidiaries (the "Company") as of December 31, 2014 and 2013, and the related consolidated statements of operations, comprehensive income (loss), changes in stockholders' equity (deficit), and cash flows for each of the two years in the period ended December 31, 2014. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Alimera Sciences, Inc. and subsidiaries as of December 31, 2014 and 2013, and the results of their operations and their cash flows for each of the two years in the period ended December 31, 2014 in conformity with accounting principles generally accepted in the United States of America.
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 3 to the consolidated financial statements, the Company has incurred recurring losses, negative cash flow from operations, and has an accumulated deficit of $313 million as of December 31, 2014. These conditions, along with the other matters as set forth in Note 3, raise substantial doubt about its ability to continue as a going concern. Management's plans in regards to these matters are also discussed in Note 3. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company's internal control over financial reporting as of December 31, 2014, based on criteria established in the 1992 Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO), and our report dated March 13, 2015 expressed an unqualified opinion.
/s/ GRANT THORNTON LLP
March 13, 2015 (except for Note 18 and the paragraph entitled Reporting Segments in Note 2, as to which the date is September 18, 2015)
ALIMERA SCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
AS OF DECEMBER 31, 2014 AND 2013
| December 31, | |||||||
| 2014 | 2013 | ||||||
| (In thousands, except share and per share data) | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 76,697 | $ | 12,628 | |||
| Accounts receivable, net | 850 | 500 | |||||
| Prepaid expenses and other current assets | 3,234 | 3,474 | |||||
| Inventory, net (Note 4) | 1,734 | 1,786 | |||||
| Deferred financing costs | 754 | 250 | |||||
| Total current assets | 83,269 | 18,638 | |||||
| PROPERTY AND EQUIPMENT - at cost less accumulated depreciation | 1,653 | 982 | |||||
| INTANGIBLE ASSET, net | 24,490 | - | |||||
| TOTAL ASSETS | $ | 109,412 | $ | 19,620 | |||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 5,021 | $ | 1,735 | |||
| Accrued expenses (Note 7) | 954 | 934 | |||||
| Accrued milestone payments | 2,000 | - | |||||
| Outsourced services payable | 1,466 | 603 | |||||
| Note payable (Note 9) | 1,023 | 1,667 | |||||
| Capital lease obligations | 11 | 10 | |||||
| Total current liabilities | 10,475 | 4,949 | |||||
| NON-CURRENT LIABILITIES: | |||||||
| Derivative warrant liability | 16,098 | 16,381 | |||||
| Note payable - less current portion (Note 9) | 33,065 | 3,194 | |||||
| Other non-current liabilities | 255 | 21 | |||||
| COMMITMENTS AND CONTINGENCIES (Note 10) | |||||||
| STOCKHOLDERS' (DEFICIT) EQUITY: | |||||||
| Preferred stock, $.01 par value - 10,000,000 shares authorized at December 31, 2014 and 2013: | |||||||
| Series A Convertible Preferred Stock, 1,300,000 authorized and 600,000 issued and outstanding at December 31, 2014 and 1,000,000 issued and outstanding at December 31, 2013; liquidation preference of $24,000 at December 31, 2014 and $40,000 at December 31, 2013 | 19,227 | 32,045 | |||||
| Series B Convertible Preferred Stock, 8,417 authorized and 8,416.251 issued and outstanding at December 31, 2014 and none issued and outstanding at December 31, 2013; liquidation preference of $50,750 at December 31, 2014 and $0 at December 31, 2013 | 49,568 | - | |||||
| Common stock, $.01 par value - 100,000,000 shares authorized, 44,320,342 shares issued and outstanding at December 31, 2014 and 31,610,991 shares issued and outstanding at December 31, 2013 | 443 | 316 | |||||
| Additional paid-in capital | 292,851 | 240,135 | |||||
| Common stock warrants | 1,497 | 412 | |||||
| Accumulated deficit | (313,255 | ) | (277,345 | ) | |||
| Accumulated other comprehensive loss | (812 | ) | (488 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | 49,519 | (4,925 | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 109,412 | $ | 19,620 |
See Notes to Consolidated Financial Statements.
ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED DECEMBER 31, 2014 AND 2013
| Years Ended December 31, | |||||||
| 2014 | 2013 | ||||||
| (In thousands, except share and per share data) | |||||||
| NET REVENUE | $ | 8,423 | $ | 1,872 | |||
| COST OF GOODS SOLD, EXCLUDING DEPRECIATION AND AMORTIZATION | (1,442 | ) | (1,863 | ) | |||
| GROSS PROFIT | 6,981 | 9 | |||||
| RESEARCH, DEVELOPMENT AND MEDICAL AFFAIRS EXPENSES | 11,811 | 8,858 | |||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 12,371 | 9,475 | |||||
| SALES AND MARKETING EXPENSES | 15,087 | 15,942 | |||||
| DEPRECIATION AND AMORTIZATION | 659 | 138 | |||||
| OPERATING EXPENSES | 39,928 | 34,413 | |||||
| NET LOSS FROM OPERATIONS | (32,947 | ) | (34,404 | ) | |||
| INTEREST EXPENSE AND OTHER | (2,090 | ) | (533 | ) | |||
| UNREALIZED FOREIGN CURRENCY (LOSS) GAIN, NET | (542 | ) | 825 | ||||
| LOSS ON EARLY EXTINGUISHMENT OF DEBT | (440 | ) | (153 | ) | |||
| CHANGE IN FAIR VALUE OF DERIVATIVE WARRANT LIABILITY | 283 | (11,964 | ) | ||||
| NET LOSS BEFORE TAXES | (35,736 | ) | (46,229 | ) | |||
| PROVISION FOR TAXES | (174 | ) | - | ||||
| NET LOSS | (35,910 | ) | (46,229 | ) | |||
| BENEFICIAL CONVERSION FEATURE OF PREFERRED STOCK (Note 11) | (750 | ) | (4,950 | ) | |||
| NET LOSS APPLICABLE TO COMMON STOCKHOLDERS | $ | (36,660 | ) | $ | (51,179 | ) | |
| NET LOSS PER SHARE APPLICABLE TO COMMON STOCKHOLDERS - Basic and diluted | $ | (0.91 | ) | $ | (1.62 | ) | |
| WEIGHTED AVERAGE SHARES OUTSTANDING - Basic and diluted | 40,397,224 | 31,579,553 |
See Notes to Consolidated Financial Statements.
ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
FOR THE YEARS ENDED DECEMBER 31, 2014 AND 2013
| Years Ended December 31, | |||||||
| 2014 | 2013 | ||||||
| (In thousands) | |||||||
| NET LOSS | $ | (35,910 | ) | $ | (46,229 | ) | |
| OTHER COMPREHENSIVE LOSS | |||||||
| Foreign currency translation adjustments | (324 | ) | (488 | ) | |||
| TOTAL OTHER COMPREHENSIVE LOSS | (324 | ) | (488 | ) | |||
| COMPREHENSIVE LOSS | $ | (36,234 | ) | $ | (46,717 | ) |
See Notes to Consolidated Financial Statements.
ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' (DEFICIT) EQUITY
FOR THE YEARS ENDED DECEMBER 31, 2014 AND 2013
| Common Stock | Series A Convertible Preferred Stock | Series B Convertible Preferred Stock | Additional Paid-In Capital | Common Stock Warrants | Accumulated Deficit | Accumulated Other Comprehensive Loss | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Total | ||||||||||||||||||||||||||||||||||
| (In thousands, except share data) | ||||||||||||||||||||||||||||||||||||||||
| BALANCE - December 31, 2012 | 31,541,286 | $ | 315 | 1,000,000 | $ | 32,045 | - | $ | - | $ | 237,485 | $ | 415 | $ | (231,116 | ) | $ | - | $ | 39,144 | ||||||||||||||||||||
| Issuance of common stock | 26,123 | - | - | - | - | - | 53 | - | - | - | 53 | |||||||||||||||||||||||||||||
| Exercise of stock options | 43,582 | 1 | - | - | - | - | 71 | - | - | - | 72 | |||||||||||||||||||||||||||||
| Modification of common stock warrants | - | - | - | - | - | - | - | 46 | - | - | 46 | |||||||||||||||||||||||||||||
| Forfeiture of common stock warrants | - | - | - | - | - | - | 49 | (49 | ) | - | - | - | ||||||||||||||||||||||||||||
| Intrinsic value of beneficial conversion feature | - | - | - | (4,950 | ) | - | - | 4,950 | - | - | - | - | ||||||||||||||||||||||||||||
| Accretion of beneficial conversion feature | - | - | - | 4,950 | - | - | (4,950 | ) | - | - | - | - | ||||||||||||||||||||||||||||
| Issuance of preferred stock, net of issuance costs | - | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||
| Stock-based compensation expense | - | - | - | - | - | - | 2,477 | - | - | - | 2,477 | |||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | (46,229 | ) | - | (46,229 | ) | |||||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | - | - | - | - | - | (488 | ) | (488 | ) | |||||||||||||||||||||||||||
| BALANCE - December 31, 2013 | 31,610,991 | 316 | 1,000,000 | 32,045 | - | - | 240,135 | 412 | (277,345 | ) | $ | (488 | ) | (4,925 | ) | |||||||||||||||||||||||||
| Issuance of common stock, net of issuance costs | 6,284,915 | 63 | - | - | - | - | 35,146 | - | - | - | 35,209 | |||||||||||||||||||||||||||||
| Exercise of stock options | 391,307 | 4 | - | - | - | - | 770 | - | - | - | 774 | |||||||||||||||||||||||||||||
| Issuance of preferred stock, net of issuance costs | - | - | - | - | 8,416 | 49,568 | - | - | - | - | 49,568 | |||||||||||||||||||||||||||||
| Conversion of preferred stock | 6,015,037 | 60 | (400,000 | ) | (12,818 | ) | - | - | 12,758 | - | - | - | - | |||||||||||||||||||||||||||
| Issuance of common stock warrants | - | - | - | - | - | - | - | 1,277 | - | - | 1,277 | |||||||||||||||||||||||||||||
| Exercise of common stock warrants | 18,092 | - | - | - | - | - | 192 | (192 | ) | - | - | - | ||||||||||||||||||||||||||||
| Intrinsic value of beneficial conversion feature | - | - | - | - | (750 | ) | 750 | - | - | - | - | |||||||||||||||||||||||||||||
| Accretion of beneficial conversion feature | - | - | - | - | - | 750 | (750 | ) | - | - | - | - | ||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | 3,850 | - | - | - | 3,850 | |||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | (35,910 | ) | - | (35,910 | ) | |||||||||||||||||||||||||||
| Foreign currency translation adjustments | - | - | - | - | - | - | - | - | - | (324 | ) | (324 | ) | |||||||||||||||||||||||||||
| BALANCE - December 31, 2014 | 44,320,342 | $ | 443 | 600,000 | $ | 19,227 | 8,416 | $ | 49,568 | $ | 292,851 | $ | 1,497 | $ | (313,255 | ) | $ | (812 | ) | $ | 49,519 |
See Notes to Consolidated Financial Statements.
ALIMERA SCIENCES, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2014 AND 2013
| Years Ended December 31, | |||||||
| 2014 | 2013 | ||||||
| (In thousands) | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
| Net loss | $ | (35,910 | ) | $ | (46,229 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 659 | 138 | |||||
| Inventory reserve | - | 410 | |||||
| Unrealized foreign currency transaction gain | 542 | (825 | ) | ||||
| Amortization of deferred financing costs and debt discount | 466 | 159 | |||||
| Loss on early extinguishment of debt | 440 | 153 | |||||
| Stock option expense | 3,850 | 2,477 | |||||
| Change in fair value of derivative warrant liability | (283 | ) | 11,964 | ||||
| Changes in assets and liabilities: | |||||||
| Accounts receivable | (444 | ) | (483 | ) | |||
| Prepaid expenses and other current assets | 206 | (1,355 | ) | ||||
| Inventory | (135 | ) | (1,416 | ) | |||
| Accounts payable | 2,987 | (259 | ) | ||||
| Accrued expenses and other current liabilities | 3,077 | (2,347 | ) | ||||
| Other long-term liabilities | 244 | (208 | ) | ||||
| Net cash used in operating activities | (24,301 | ) | (37,821 | ) | |||
| CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
| Payment of license intangible (Note 6) | (25,000 | ) | - | ||||
| Purchases of property and equipment | (842 | ) | (973 | ) | |||
| Net cash used in investing activities | (25,842 | ) | (973 | ) | |||
| CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
| Proceeds from exercise of stock options | 774 | 72 | |||||
| Proceeds from sale of common stock | 37,598 | 53 | |||||
| Payment of issuance cost of common stock | (2,389 | ) | - | ||||
| Proceeds from issuance of Series B convertible preferred stock | 50,000 | - | |||||
| Payment of Series B convertible preferred stock offering costs | (105 | ) | - | ||||
| Proceeds from issuance of notes payable (Note 9) | 35,000 | 5,000 | |||||
| Payment of debt issuance costs (Note 9) | (1,016 | ) | (291 | ) | |||
| Payment of principal on notes payable | (4,861 | ) | (3,169 | ) | |||
| Payment of debt extinguishment costs | (246 | ) | - | ||||
| Payments on capital lease obligations | (10 | ) | (11 | ) | |||
| Net cash provided by financing activities | 114,745 | 1,654 | |||||
| EFFECT OF EXCHANGE RATES ON CASH AND CASH EQUIVALENTS | (533 | ) | 204 | ||||
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 64,069 | (36,936 | ) | ||||
| CASH AND CASH EQUIVALENTS - Beginning of year | 12,628 | 49,564 | |||||
| CASH AND CASH EQUIVALENTS - End of year | $ | 76,697 | $ | 12,628 | |||
| SUPPLEMENTAL DISCLOSURES: | |||||||
| Cash paid for interest | $ | 1,247 | $ | 607 | |||
| Supplemental schedule of noncash investing and financing activities: | |||||||
| Conversion of Series A Convertible Preferred Stock to common stock | $ | 12,818 | $ | - | |||
| Series B Convertible Preferred Stock offering costs accrued but unpaid | $ | 327 | $ | - | |||
| Property and equipment acquired under capital leases | $ | - | $ | 33 |
There were no income tax or dividend payments made for the years ended December 31, 2014 and 2013.
See Notes to Consolidated Financial Statements.
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Alimera Sciences, Inc., and its wholly-owned subsidiaries, (the Company) is a pharmaceutical company that specializes in the research, development, and commercialization of ophthalmic pharmaceuticals. The Company was formed on June 4, 2003 under the laws of the State of Delaware.
The Company is presently focused on diseases affecting the back of the eye, or retina, because the Company's management believes these diseases are not well treated with current therapies and represent a significant market opportunity. The Company's only commercial product is ILUVIEN , which has received marketing authorization in the United States (U.S.), Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden and the United Kingdom and has been recommended for marketing authorization in Poland. In the U.S., ILUVIEN is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). In the European Union (EU) countries in which ILUVIEN has received marketing authorization, it is indicated for the treatment of vision impairment associated with DME considered insufficiently responsive to available therapies. As part of the approval process in these countries, the Company has committed to conduct a five-year, post-authorization, open label registry study of ILUVIEN in 800 patients treated per the labeled indication.
The Company launched ILUVIEN in the United Kingdom and Germany in the second quarter of 2013 and in Portugal and the U.S. in the first quarter of 2015. To date, the majority of the Company's sales have been in Germany and the United Kingdom. The Company was able to launch in Germany without price restrictions, but continues to work with the statutory health insurance funds in Germany to streamline reimbursement for ILUVIEN.
In October 2013, the United Kingdom's National Institute for Health and Care Excellence (NICE) issued a positive Final Appraisal Determination recommending ILUVIEN funding, taking into consideration a simple patient access scheme (PAS) for the treatment of pseudophakic eyes (eyes with an artificial lens) in chronic DME patients considered insufficiently responsive to available therapies. The Company began receiving orders for ILUVIEN from several National Health Service (NHS) facilities in January 2014 following the final technology appraisal guidance that was published in November 2013. Further, in February 2014, the Scottish Medicines Consortium, after completing its assessment and review of a similar simple PAS, announced that is has accepted ILUVIEN for restricted use within the NHS Scotland.
In July 2013, the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante) issued a favorable opinion for the reimbursement and hospital listing of ILUVIEN by the French National Health Insurance for the treatment of chronic DME considered insufficiently responsive to available therapies. The Company continues to negotiate with the French authorities, but has not yet reached an agreement on price.
In July 2014, the Company reached agreement with INFARMED, the marketing authorization body of the Portuguese Ministry of Health, for the pricing and reimbursement of ILUVIEN for the public sector in Portugal.
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
The following accounting policies relate primarily to the continuing operations of the Company:
Use of Estimates in Financial Statements - The financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America and, as such, include amounts based on informed estimates and judgments of management. Actual results could differ from those estimates.
Principles of Consolidation - The consolidated financial statements include the accounts of Alimera Sciences, Inc. and all wholly-owned subsidiaries. All significant inter-company balances have been eliminated in consolidation.
Reclassifications - Within the operating expenses section of the Consolidated Statements of Operations for the year ended December 31, 2013, the Company reclassified depreciation expense of $138,000 from general and administrative expenses to depreciation and amortization to conform to the current year presentation. In addition, the Company reclassified certain medical affairs support expenses of $448,000 and $429,000 for the year ended December 31, 2014 and 2013, respectively, from sales and marketing expenses to research, development and medical affairs expenses.
Cash and Cash Equivalents - Cash and cash equivalents include cash and highly liquid investments that are readily convertible into cash and have a maturity of 90 days or less when purchased. Generally, cash and cash equivalents held at financial institutions are in excess of federally insured limits. The Company limits its exposure to credit loss by placing its cash and cash equivalents in highly liquid investments with high quality financial institutions. Cash and cash equivalents were $76,697,000 and $12,628,000 at December 31, 2014 and 2013, respectively, with approximately 96.0% and 100.0% of these balances, respectively held in U.S. based financial institutions.
Revenue Recognition - The Company recognizes revenue from its product sales when persuasive evidence of an arrangement exists, title to product and associated risk of loss have passed to the customer, the price is fixed or determinable, and collection from the customer is reasonably assured. Title passes generally upon shipment or upon receipt by the customer depending on the agreement with the customer. Precise information regarding the receipt of product by the customer is not always readily available. In these cases, the Company estimates the date of receipt based upon shipping policies by geographic location. The Company's shipping policies require delivery within 24 hours of shipment in most instances. Taxes that are collected from customers and remitted to governmental authorities are not included in revenue.
Accounts Receivable and Allowance for Doubtful Accounts - Accounts receivable are generated through sales primarily to pharmacies, hospitals and wholesalers which began in 2013. The Company does not require collateral from its customers for accounts receivable. The carrying amount of accounts receivable is reduced by an allowance for doubtful accounts that reflects management's best estimate of the amounts that will not be collected. In addition to reviewing delinquent accounts receivable, management considers many factors in estimating its general allowance, including historical data, experience, customer types, credit worthiness, and economic trends. From time to time, management may adjust its assumptions for anticipated changes in any of those or other factors expected to affect collectability. Provisions for doubtful accounts are charged to operations at the time management determines these accounts may become uncollectable. The Company writes off accounts receivable when management determines they are uncollectable and credits payments subsequently received on such receivables to bad debt expense in the period received. There were accounts receivable write-offs of $21,000 for the year ended December 31, 2014 and no allowance for doubtful accounts at December 31, 2014. There were no accounts receivable write-offs for the year ended December 31, 2013 and no allowance for doubtful accounts at December 31, 2013.
Inventory - Inventories are stated at the lower of cost or market with cost determined under the first in, first out (FIFO) method. Included in inventory costs are component parts, work-in-progress and finished goods. The Company relies on third party manufacturers for the production of all inventory and does not capitalize any internal costs. The Company periodically reviews inventories for excess, obsolete or expiring inventory and writes down obsolete or otherwise unmarketable inventory to its estimated net realizable value. If the actual net realizable value is less than that estimated, or if there are any further determinations that inventory will not be marketable based on estimates of demand, additional inventory write-downs will be required.
Intangible Assets - The cost of intangible assets with determinable useful lives is amortized to reflect the pattern of economic benefits consumed, which approximates a straight-line basis, over the estimated periods benefited. The estimated useful life of the intangible asset is approximately thirteen years.
Property and Equipment - Property and equipment are stated at cost. Additions and improvements are capitalized while repairs and maintenance are expensed. Depreciation is provided on the straight-line method over the useful life of the related assets beginning when the asset is placed in service. The estimated useful lives of the individual assets are as follows: furniture
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
and fixtures and manufacturing equipment, five years; office equipment and leasehold improvements, 29 months to five years; and software, three years.
Impairment - Property and equipment and intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When indicators of impairment are present, the Company evaluates the carrying amount of such assets in relation to the operating performance and future estimated undiscounted net cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. The assessment of the recoverability of assets will be impacted if estimated future operating cash flows are not achieved.
Income Taxes - In accordance with the Financial Accounting Standards Board (FASB) Accounting Standard Codification (ASC) 740, Income Taxes, the Company recognizes deferred tax assets and liabilities for temporary differences between the financial reporting basis and the tax basis of its assets and liabilities. The Company records a valuation allowance against its net deferred tax asset to reduce the net carrying value to an amount that is more likely than not to be realized.
Income tax positions are considered for uncertainty in accordance with ASC 740-10. The Company believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position; therefore, no ASC 740-10 liabilities have been recorded. The Company will recognize accrued interest and penalties related to unrecognized tax benefits, if any, as interest expense and income tax expense, respectively, in the consolidated statements of operations.
Significant management judgment is involved in determining the provision for income taxes, deferred tax assets and liabilities, and any valuation allowance recorded against net deferred tax assets. Due to uncertainties with respect to the realization of deferred tax assets as a result of the Company's history of operating losses, a valuation allowance has been established against the net deferred tax asset balance. The valuation allowance is based on management's estimates of taxable income in the jurisdictions in which the Company operates and the period over which deferred tax assets will be recoverable. In the event that actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact the Company's financial position and results of operations.
Research and Development Costs - Research and development costs are expensed as incurred. Research and development expenses were $7,594,000 and $3,904,000 for the year ended December 31, 2014 and 2013, respectively.
Stock-Based Compensation - The Company has stock option plans which provide for grants of stock options to employees and directors to purchase shares of the Company's common stock at exercise prices generally equal to the fair market values of such stock at the dates of grant. Compensation cost is recognized for all share-based awards based on the grant date fair value in accordance with the provisions of ASC 718, Compensation - Stock Compensation. The fair values for the options are estimated at the dates of grant using a Black-Scholes option-pricing model.
Additionally, the Company sponsors an employee stock purchase plan under which employees may elect payroll withholdings to fund purchases of the Company's stock at a discount. The Company estimates the fair value of the option to purchase shares of the Company's common stock using the Black-Scholes valuation model and recognizes compensation expense in accordance with the provisions of ASC 718-50, Employee Share Purchase Plans.
Derivative Financial Instruments - The Company generally does not use derivative instruments to hedge exposures to cash flow or market risks. However, certain warrants to purchase Series A convertible Preferred Stock or common stock that do not meet the requirements for classification as equity, in accordance with the Derivatives and Hedging Topic of the ASC, are classified as liabilities. In such instances, net-cash settlement is assumed for financial reporting purposes, even when the terms of the underlying contracts do not provide for a net-cash settlement. These warrants were considered derivative instruments at issuance because the agreements provide for settlement in Series A Convertible Preferred Shares or common shares at the option of the holder, an adjustment to the warrant exercise price for common shares at some point in the future, and contain anti-dilution provisions whereby the number of shares for which the warrants are exercisable and/or the exercise price of the warrants are subject to change in the event of certain issuances of stock at prices below the then-effective exercise price of the warrants. The warrant exercise price no longer can be adjusted at some point in the future. The primary underlying risk exposure pertaining to the warrants is the change in fair value of the underlying common stock. Such financial instruments are initially recorded at fair value with subsequent changes in fair value recorded as a component of change in fair value of derivative warrant liability in the consolidated statements of operations in each reporting period. If these instruments subsequently meet the requirements for equity classification, the Company reclassifies the fair value to equity. At December 31, 2014 and 2013, these warrants represented the only outstanding derivative instruments issued or held by the Company.
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
Fair Value of Financial Instruments - The carrying amounts of the Company's financial instruments, including cash and cash equivalents and current assets and liabilities approximate their fair value because of their short maturities. The weighted average interest rate of the Company's notes payable approximates the rate at which the Company could obtain alternative financing; therefore, the carrying amount of the note approximates the fair value. The Company uses the Black-Scholes option pricing model and assumptions that consider, among other variables, the fair value of the underlying stock, risk-free interest rate, volatility, expected life and dividend rates in estimating fair value for the warrants considered to be derivative instruments.
Translation Policy - The U.S. dollar is the functional currency for Alimera Sciences, Inc. The Euro is the functional currency for the majority of the Company's subsidiaries operating outside of the U.S.
For Alimera Sciences, Inc., foreign currency assets and liabilities are remeasured into U.S. dollars at end-of-period exchange rates, except for non-monetary balance sheet accounts, which are remeasured at historical exchange rates. Revenue and expenses are remeasured at average exchange rates in effect during each period, except for those expenses related to the non-monetary balance sheet amounts, which are remeasured at historical exchange rates. Gains or losses from foreign currency remeasurement are included in the statement of operations.
The financial statements of the foreign subsidiaries whose functional currency is not the U.S. dollar, have been translated into U.S. dollars in accordance with ASC 830-30, Translation of Financial Statements. For the subsidiaries operating outside of the U.S. that are denominated in the Euro, assets and liabilities are translated at end-of-period rates while revenues and expenses are translated at average rates in effect during the period in which the activity took place. Equity is translated at historical rates and the resulting cumulative translation adjustments are included as a component of accumulated other comprehensive income.
Earnings (Loss) Per Share (EPS) - Basic EPS is calculated in accordance with ASC 260, Earnings per Share by dividing net income or loss attributable to common stockholders by the weighted average common stock outstanding. Diluted EPS is calculated in accordance with ASC 260 by adjusting weighted average common shares outstanding for the dilutive effect of common stock options, warrants, convertible preferred stock and accrued but unpaid convertible preferred stock dividends. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, since the effect would be anti-dilutive. Common stock equivalent securities that would potentially dilute basic EPS in the future, but were not included in the computation of diluted EPS because to do so would have been anti-dilutive, were as follows:
| Years Ended December 31, | |||||
| 2014 | 2013 | ||||
| Series A convertible preferred stock | 9,022,556 | 15,037,594 | |||
| Series B convertible preferred stock | 8,416,251 | - | |||
| Series A convertible preferred stock warrants | 4,511,279 | 4,511,279 | |||
| Common stock warrants | 362,970 | 109,772 | |||
| Stock options | 7,681,256 | 7,566,437 | |||
| Total | 29,994,312 | 27,225,082 |
Reporting Segments - The Company determines operating segments in accordance with its internal operating structure. The Company's chief operating decision maker is the Chief Executive Officer (CEO). While the CEO is apprised of a variety of financial metrics and information, the business is principally managed and organized based upon geographic and regulatory environment. Each segment is separately managed and is evaluated primarily upon net loss from operations. The Company does not report balance sheet information by segment since it is not reviewed by the Company's chief operating decision maker. The Company has two reportable segments, the U.S. and International.
Previously, the business was managed on an aggregate basis. During the second quarter of 2015, the CEO began managing the Company's operations as two operating business segments. As a result of the retrospective presentation and disclosure requirements under U.S. GAAP for changes in segment reporting, the Company is required to reflect the change in presentation and disclosure for all periods presented. As such, the Company has presented in Note 18, Segment Information, the financial results for the years ended December 31, 2014 and 2013.
Promotional and Advertising Costs - Promotional and advertising costs are expensed as incurred.
Recent Accounting Pronouncements - In May 2014, the FASB issued Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers (Topic 606). ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. The revenue guidance contains principles that an entity will apply to determine the
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
measurement of revenue and timing of when it is recognized. The underlying principle is that an entity will recognize revenue to depict the transfer of goods or services to customers at an amount that the entity expects to be entitled to in exchange for those goods or services. The standard will be effective for the first interim period within annual reporting periods beginning after December 15, 2016 for public entities, with no early adoption permitted. The Company is still evaluating the potential impact of adopting this guidance on its financial statements.
In June 2014, the FASB issued ASU 2014-12, Compensation Stock - Compensation (Topic 718). ASU 2014-12 applies to all reporting entities that grant their employees share-based payments in which the terms of the award provide that a performance target that affects vesting could be achieved after the requisite service period. It requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition and follows existing accounting guidance for the treatment of performance conditions. The standard will be effective for annual periods and interim periods within those annual periods beginning after December 15, 2015, with early adoption permitted. The Company is still evaluating the potential impact of adopting this guidance on its financial statements.
In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements-Going Concern. ASU 2014-15 provides guidance around management's responsibility to evaluate whether there is substantial doubt about an entity's ability to continue as a going concern and to provide related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company's ability to continue as a going concern within one year from the date the financial statements are issued. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption is permitted. The Company is still evaluating the potential impact of adopting this guidance on its financial statements.
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
3. FACTORS AFFECTING OPERATIONS
To date the Company has incurred recurring losses, negative cash flow from operations, and has accumulated a deficit of $313,255,000 from the Company's inception through December 31, 2014. As of December 31, 2014, the Company had approximately $76,697,000 in cash and cash equivalents.
The Company believes that it has sufficient funds available to fund its operations for the continued commercialization of ILUVIEN in Germany and the United Kingdom, and the launch of ILUVIEN in Portugal and the U.S. The Company does not expect the generation of positive cash flow from operations until 2016, at the earliest, if at all. The Company may seek to raise additional financing to fund its working capital needs associated with the commercialization of ILUVIEN in the U.S. If the Company is unable to raise additional financing, then it may adjust its commercial plans so that it can continue to operate with its existing cash resources.
The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company's recurring net losses, negative cash flow from operations and accumulated deficit raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Inventory consisted of the following:
| December 31, | |||||||
| 2014 | 2013 | ||||||
| (In thousands) | |||||||
| Component parts (1) | $ | 76 | $ | 266 | |||
| Work-in-process (2) | 219 | 587 | |||||
| Finished goods | 1,972 | 1,343 | |||||
| Total inventory | 2,267 | 2,196 | |||||
| Inventory reserve | (533 | ) | (410 | ) | |||
| Inventory - net | $ | 1,734 | $ | 1,786 |
(1) Component parts inventory consisted of manufactured components of the ILUVIEN applicator.
(2) Work-in-process consisted of completed units of ILUVIEN that are undergoing, but have not completed, quality assurance testing as required by U.S. or EU regulatory authorities.
ALIMERA SCIENCES, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - (Continued)
5. PROPERTY AND EQUIPMENT