2. Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2015 |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Liquidity, Risks and Uncertainties |
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The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates, the ability to obtain regulatory approval to market its products, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital. |
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The financial statements have been prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company as a going concern. As of March 31, 2015, the Company had an accumulated deficit of $81.7 million, had incurred operating losses of $5.5 million for the three months ended March 31, 2015 and $8.9 million for the year ended December 31, 2014. |
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To date, the Company has not generated significant commercial revenues. Based on the current 2015 revenue assumptions for Neutrolin in the approved markets, the current development plans for Neutrolin in both the United States (“U.S.”) and other markets (excluding the expected Phase III clinical trial in the U.S.) and the proceeds received from the exercise of warrants, stock options (see Notes 3 and 6) and capital raised under the MLV Sales Agreement through April 30, 2015 (See Note 6), management believes that the existing cash will be sufficient to fund its operations for at least the next twelve months following the balance sheet date. However, should the Company commence the Phase III clinical trial for Neutrolin in hemodialysis patients in the U.S. in the fourth quarter of 2015, at present there is only sufficient funding to support operations and expected clinical trial expenditures into the first quarter of 2016. |
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The Company’s continued operations, including the commencement and completion of its planned Phase III clinical trial for Neutrolin in hemodialysis patients in the U.S. will depend on its ability to generate substantial revenue from the sale of Neutrolin and on its ability raise additional capital through potential sources such as equity and/or debt financings, strategic relationships, or out-licensing of its products, until it achieves profitability, if ever. However, the Company can provide no assurances on future sales of Neutrolin or that such financing or strategic relationships will be available on acceptable terms, or at all. If the Company is unable to raise sufficient capital, find strategic partners or generate substantial revenue from the sale of Neutrolin, there would be a material adverse effect on its business. Further, the Company expects to incur increases in its cash used in operations as it continues to commercialize Neutrolin in Europe and other foreign markets, increases its business development activities, incurs additional legal costs to defend its intellectual property and seeks U.S. Food and Drug Administration (“FDA”) approval of Neutrolin in the U.S. |
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Use of Estimates |
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The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. |
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Basis of Consolidation |
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The consolidated financial statements include the accounts of the Company and CorMedix Europe GmbH, a wholly owned subsidiary. All significant intercompany accounts and transactions have been eliminated in consolidation. |
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Cash and Cash Equivalents |
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Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its cash and cash equivalents in bank deposits and other interest bearing accounts, the balances of which exceed federally insured limits. |
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Foreign Currency Translation and Transactions |
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The consolidated financial statements are presented in U.S. Dollars (“USD”), the reporting currency of the Company. For the financial statements of the Company’s foreign subsidiary, whose functional currency is the EURO, foreign currency asset and liability amounts, are translated into USD at end-of-period exchange rates. Foreign currency income and expenses are translated at average exchange rates in effect during the year. Translation gains and losses are included in other comprehensive income (loss). |
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The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. Effective October 1, 2014, the Company assessed and determined that the intercompany loans outstanding are not expected to be repaid in the foreseeable future and the nature of the funding advanced is of a long-term investment nature. As such, beginning October 1, 2014, unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss). |
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Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the entity recording the transaction. |
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Geographic Information |
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The Company reported revenues of $31,264 and $12,203 for the three months ended March 31, 2014 and 2014, respectively. Of the Company’s first quarter 2015 revenue, $29,058 was attributable to its European and Mideast operations which are based in Germany. All of the Company’s 2014 revenue was attributable to its European operations. Total assets at March 31, 2015 were $9,751,752, of which $9,003,018 were located in the United States, with the remainder in Germany. Net property and equipment at March 31, 2015 was $47,011, of which $13,523 was located in the United States, with the remainder located in Germany. |
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Prepaid Expenses |
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Prepaid expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, preclinical development and insurance policies. These advanced payments are amortized to expense either as services are performed or over the relevant service period using the straight-line method. |
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Inventories, net |
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Inventories are valued at the lower of cost or market on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the Neutrolin product. Inventories consist of the following: |
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| | March 31, | | | December 31, | |
2015 | 2014 |
Raw materials | | $ | 293,756 | | | $ | 293,976 | |
Work in process | | | 166,807 | | | | 166,807 | |
Finished goods | | | 842 | | | | 2,246 | |
Total | | $ | 461,405 | | | $ | 463,029 | |
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The Company has an inventory reserve of $175,000 at March 31, 2015 and December 31, 2014. |
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Accrued Expenses |
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Accrued expenses consist of the following: |
| | March 31, | | | December 31, | |
2015 | 2014 |
Professional and consulting fees | | $ | 325,942 | | | $ | 225,726 | |
Accrued payroll and payroll taxes | | $ | 130,751 | | | $ | 13,393 | |
Market research | | | 70,816 | | | | 137,345 | |
Monitoring program fees | | | 119,350 | | | | 82,861 | |
Other | | | 35,296 | | | | 62,200 | |
Total | | $ | 682,155 | | | $ | 521,525 | |
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Revenue Recognition |
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The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin (“SAB”) No. 101, Revenue Recognition in Financial Statements (“SAB 101”), as amended by SAB No. 104, Revenue Recognition (“SAB 104”) and FASB Accounting Standards Codification (“ASC”) 605, Revenue Recognition (“ASC 605”). This guidance requires that revenue is recognized from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable, and collectability is reasonably assured. The Company recognizes net sales upon shipment of product. |
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Deferred Revenue |
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In August 2014, the Company entered into an exclusive distribution agreement (the “Agreement”) with Wonik Corporation, a South Korean company, to market, sell and distribute Neutrolin for hemodialysis and oncolytic patients upon receipt of regulatory approval in Korea. Upon execution of the Agreement, Wonik paid the Company a non-refundable $50,000 payment and will pay an additional $50,000 upon receipt of the product registration necessary to sell Neutrolin in the Republic of Korea (the “Territory”). The term of the agreement commenced on August 8, 2014 and will continue for three years after the first commercial sale of Neutrolin in the Territory. The non-refundable up-front payment has been recorded as deferred revenue and will be recognized as revenue on a straight-line basis over the contractual term of the Agreement. |
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Loss per common share |
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Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. |
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| | Three Months Ended | |
| | 31-Mar-15 | | | 31-Mar-14 | |
Series B non-voting convertible preferred stock | | | - | | | | 454,546 | |
Series C non-voting convertible preferred stock | | | 2,865,000 | | | | 3,500,000 | |
Series D non-voting convertible preferred stock | | | 1,479,240 | | | | 1,148,000 | |
Series E non-voting convertible preferred stock | | | 1,959,759 | | | | 1,104,280 | |
Shares underlying outstanding warrants | | | 6,890,327 | | | | 11,571,233 | |
Shares underlying outstanding stock options | | | 4,014,500 | | | | 3,804,000 | |
Total | | | 17,208,826 | | | | 21,582,059 | |
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Stock-Based Compensation |
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The Company accounts for stock options granted to employees, officers and directors according to the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) No. 718, “Compensation — Stock Compensation” (“ASC 718”). Under ASC 718, share-based compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model, and is recognized as expense net of expected forfeitures, over the employee’s requisite service period on a straight-line basis. |
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The Company accounts for stock options granted to non-employees on a fair value basis using the Black-Scholes option pricing model in accordance with ASC 718 and ASC 505-50, “Equity-Based Payments to Non-Employees” (“ASC 505”). The non-cash charge to operations for non-employee options with time based vesting provisions is based upon the change in the fair value of the options and amortized to expense over the related vesting period. |
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Stock compensation expense is recognized by applying the expected forfeiture rate during the vesting period to the fair value of the award. The estimation of the number of stock awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, compensation expense may need to be revised. The Company considers many factors when estimating expected forfeitures for stock awards granted to employees, officers and directors, including types of awards, employee class, and an analysis of historical forfeitures. |
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Research and Development |
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Research and development costs are charged to expense as incurred. Research and development includes fees associated with operational consultants, contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses. The Company accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external service providers. Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations as incurred and considered a component of research and development expense. |