Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Mar. 09, 2015 | Jun. 30, 2014 | |
Document And Entity Information | |||
Entity Registrant Name | CorMedix Inc. | ||
Entity Central Index Key | 1410098 | ||
Document Type | 10-K | ||
Document Period End Date | 31-Dec-14 | ||
Amendment Flag | FALSE | ||
Current Fiscal Year End Date | -19 | ||
Is Entity a Well-known Seasoned Issuer? | No | ||
Is Entity a Voluntary Filer? | No | ||
Is Entity's Reporting Status Current? | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Public Float | $37,400,000 | ||
Entity Common Stock, Shares Outstanding | 24,122,522 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2014 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Current assets | ||
Cash and cash equivalents | $4,339,540 | $2,373,893 |
Restricted cash | 0 | 220,586 |
Trade receivables | 80,183 | 2,339 |
Inventories, net | 463,029 | 80,021 |
Prepaid research and development expenses | 0 | 6,205 |
Other prepaid expenses and current assets | 155,210 | 232,987 |
Total current assets | 5,037,962 | 2,916,031 |
Property and equipment, net | 41,458 | 36,061 |
Deferred financing costs | 0 | 2,366 |
Security deposit | 18,342 | 13,342 |
TOTAL ASSETS | 5,097,762 | 2,967,800 |
Current liabilities | ||
Accounts payable | 893,385 | 939,785 |
Accrued expenses | 521,525 | 713,179 |
Deferred rent | 1,654 | 0 |
Deferred revenue | 8,823 | 0 |
Dividend payable | 0 | 21,117 |
Total current liabilities | 1,425,387 | 1,674,081 |
Derivative liability | 0 | 5,308,804 |
Deferred rent, long term | 403 | 7,258 |
Deferred revenue, long term | 37,500 | 0 |
TOTAL LIABILITIES | 1,463,290 | 6,990,143 |
STOCKHOLDERS' DEFICIT | ||
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 949,948 and 857,160 shares issued and outstanding at December 31, 2014 and 2013, respectively (See Note 8) | 950 | 857 |
Common stock - $0.001 par value: 80,000,000 shares authorized; 22,461,668 and 16,606,695 shares issued and outstanding at December 31, 2014 and 2013, respectively | 22,461 | 16,606 |
Deferred stock issuances | -110 | -146 |
Accumulated other comprehensive gain (loss) | 98,972 | -9,323 |
Additional paid-in capital | 79,716,265 | 51,720,302 |
Accumulated deficit | -76,204,066 | -55,750,639 |
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) | 3,634,472 | -4,022,343 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY) | $5,097,762 | $2,967,800 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 2,000,000 | 2,000,000 |
Preferred stock, shares issued | 949,948 | 857,160 |
Preferred stock, shares outstanding | 949,948 | 857,160 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 80,000,000 | 80,000,000 |
Common stock, shares issued | 22,461,668 | 16,606,695 |
Common stock, shares outstanding | 22,461,668 | 16,606,695 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations and Comprehensive Gain (Loss) (Unaudited) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Revenue | ||
Net sales | $189,274 | $2,001 |
Cost of sales | -445,799 | -201,605 |
Gross loss | -256,525 | -199,604 |
OPERATING EXPENSES | ||
Research and development | -1,318,734 | -1,226,874 |
Selling, general and administrative | -7,326,861 | -3,488,917 |
Total Operating Expenses | -8,645,595 | -4,715,791 |
LOSS FROM OPERATIONS | -8,902,120 | -4,915,395 |
OTHER INCOME (EXPENSE) | ||
Other income (expense) | 0 | -4,513 |
Interest income | 2,714 | 668 |
Foreign exchange transaction gain (loss) | -150,803 | 0 |
Loss on issuance of preferred stock, convertible notes and warrants | -89,590 | -945,892 |
Change in fair value of derivative liabilities | -8,848,953 | -363,919 |
Loss on modification of equity instruments and extinguishment of derivative liabilities | 2,462,588 | 0 |
Loss on extinguishment of convertible notes | 0 | -1,459,661 |
Interest expense, including amortization and write-off of deferred financing costs and debt discounts | -2,087 | -1,444,386 |
NET LOSS | -20,453,427 | -9,133,098 |
Other Comprehensive Loss | ||
Foreign currency translation gain (loss) | 108,295 | -9,323 |
Comprehensive Loss | -20,345,132 | -9,142,421 |
NET LOSS | -20,453,427 | -9,133,098 |
Dividends, including beneficial conversion feature | -82,899 | -384,307 |
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS | ($20,536,326) | ($9,517,405) |
NET LOSS PER COMMON SHARE - BASIC AND DILUTED | ($0.96) | ($0.69) |
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED | 21,441,906 | 13,823,130 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Shareholders Equity (USD $) | Common Stock | Preferred Stock | Deferred Stock Issuances | Accumulated Other Comprehensive Gain (Loss) | Additional Paid-In Capital | Retained Earnings / Accumulated Deficit | Total |
Beginning balance at Dec. 31, 2012 | $11,408 | $0 | ($146) | $0 | $45,886,596 | ($46,233,234) | ($335,376) |
Beginning balance (in shares) at Dec. 31, 2012 | 11,408,274 | 0 | |||||
Series A non-voting preferred stock issued in February 2013 private placement at $0.70 per share, net, shares | 761,429 | ||||||
Series A non-voting preferred stock issued in February 2013 private placement at $0.70 per share, net, amount | 761 | 506,372 | 507,133 | ||||
Conversion of Series A non-voting preferred stock to common stock and reclassification of derivative liability to equity, shares | 761,429 | -761,429 | |||||
Conversion of Series A non-voting preferred stock to common stock and reclassification of derivative liability to equity, amount | 761 | -761 | |||||
Deemed dividend related to beneficial conversion feature of Series A non-voting preferred stock | 309,944 | -309,944 | |||||
Series B non-voting preferred stock issued in July 2013 private placement at $1.10 per share, net, shares | 454,546 | ||||||
Series B non-voting preferred stock issued in July 2013 private placement at $1.10 per share, net, amount | 455 | 480,007 | 480,462 | ||||
Deemed dividend related to beneficial conversion feature of Series B non-voting preferred stock | 53,246 | -53,246 | |||||
Repurchase of outstanding warrants | -33,000 | -33,000 | |||||
Dividends related to Series D and Series E preferred stock | -21,117 | -21,117 | |||||
Warrants issued in connection with license agreement | 76,574 | 76,574 | |||||
Stock issued in connection with 9% senior convertible note at $0.35 per share, shares | 2,640,000 | ||||||
Stock issued in connection with 9% senior convertible note at $0.35 per share, amount | 2,640 | 921,360 | 924,000 | ||||
Stock issued in connection with 8% senior convertible note and interest conversion, fair value | 1,009,238 | ||||||
Stock issued in connection with 8% senior convertible note and interest conversion, fair value | 1,009 | 866,557 | 867,566 | ||||
Stock issued in connection with warrants exercised, Shares | 677,754 | ||||||
Stock issued in connection with warrants exercised, Amount | 678 | 59,322 | 60,000 | ||||
Stock issued in connection with stock options exercised, Shares | 10,000 | ||||||
Stock issued in connection with stock options exercised, Amount | 10 | 2,390 | 2,400 | ||||
Series C-1 and Series C-2 non-voting preferred stock issued in October 2013 financing at $10 per share, net, fair value | 300,000 | ||||||
Series C-1 and Series C-2 non-voting preferred stock issued in October 2013 financing at $10 per share, net, fair value | 300 | 57,555 | 57,855 | ||||
Conversion of Series C-1 non-voting preferred stock to common stock, shares | 100,000 | -10,000 | |||||
Conversion of Series C-1 non-voting preferred stock to common stock, amount | 100 | -10 | 69,015 | 69,105 | |||
Stock issued in connection with the exchange of 8% senior convertible notes and interest into Series D non-voting preferred stock, net, fair value | 57,400 | ||||||
Stock issued in connection with the exchange of 8% senior convertible notes and interest into Series D non-voting preferred stock, net, fair value | 57 | 500,169 | 500,226 | ||||
Stock issued in connection with the exchange of 8% senior convertible notes and interest into Series E non-voting preferred stock, net, fair value, shares | 55,214 | ||||||
Stock issued in connection with the exchange of 8% senior convertible notes and interest into Series E non-voting preferred stock, net, fair value, amount | 55 | 619,059 | 619,114 | ||||
Stock-based compensation | 1,345,136 | 1,345,136 | |||||
Other comprehensive gain (loss) | -9,323 | -9,323 | |||||
Net loss | -9,133,098 | -9,133,098 | |||||
Ending balance at Dec. 31, 2013 | 16,606 | 857 | -146 | -9,323 | 51,720,302 | -55,750,639 | -4,022,343 |
Ending balance (in shares) at Dec. 31, 2013 | 16,606,695 | 857,160 | |||||
Series C-3 non-voting preferred stock issued in January 2014 financing at $10 per share, net, Shares | 200,000 | ||||||
Series C-3 non-voting preferred stock issued in January 2014 financing at $10 per share, net, Amount | 200 | 200 | |||||
Repurchase of outstanding warrants | 0 | ||||||
Stock issued in connection with March 2014 public offering at $2.50 per unit, net, Shares | 2,960,000 | ||||||
Stock issued in connection with March 2014 public offering at $2.50 per unit, net, Amount | 2,960 | 4,991,838 | 4,994,798 | ||||
Reclassification of Series C-2 and C-3 preferred stock conversion option derivative liability to equity, Amount | 6,235,398 | 6,235,398 | |||||
Reclassification of derivative liabilities to equity from modification of various equity instruments including payment-in-kind dividends, shares | 53,788 | ||||||
Reclassification of derivative liabilities to equity from modification of various equity instruments including payment-in-kind dividends, amount | 54 | 11,740,809 | 11,740,863 | ||||
Shares held in escrow upon achievement of certain milestone | 36 | -36 | 0 | ||||
Stock issued in connection with warrants exercised, Shares | 772,589 | ||||||
Stock issued in connection with warrants exercised, Amount | 773 | -773 | 0 | ||||
Conversion of Series C-3 non-voting preferred stock to common stock, shares | 210,000 | -21,000 | |||||
Conversion of Series C-3 non-voting preferred stock to common stock, amount | 210 | -21 | -189 | 0 | |||
Stock issued in connection with stock options exercised, Shares | 455,000 | ||||||
Stock issued in connection with stock options exercised, Amount | 455 | 317,695 | 318,150 | ||||
Conversion of Series C-1 non-voting preferred stock to common stock, shares | 1,400,000 | -140,000 | |||||
Conversion of Series C-1 non-voting preferred stock to common stock, amount | 1,400 | -140 | 2,446,124 | 2,447,384 | |||
Conversion of wages and fee to common stock, Shares | 57,384 | ||||||
Conversion of wages and fee to common stock, Amount | 57 | 96,794 | 96,851 | ||||
Stock-based compensation | 2,168,303 | 2,168,303 | |||||
Other comprehensive gain (loss) | 108,295 | 108,295 | |||||
Net loss | -20,453,427 | -20,453,427 | |||||
Ending balance at Dec. 31, 2014 | $22,461 | $950 | ($110) | $98,972 | $79,716,265 | ($76,204,066) | $3,634,472 |
Ending balance (in shares) at Dec. 31, 2014 | 22,461,668 | 949,948 |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | ($20,453,427) | ($9,133,098) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,168,303 | 1,345,136 |
Warrants issued in connection with license agreement | 0 | 76,574 |
Amortization of deferred financing costs | 0 | 282,886 |
Amortization of debt discount | 0 | 1,054,255 |
Loss on foreign exchange transactions | 150,803 | 0 |
Loss on issuance of preferred stock, convertible notes and warrants | 89,590 | 945,892 |
Loss on modification of equity instruments and extinguishment of derivative liabilities | 2,462,588 | 1,459,661 |
Non-cash interest expense | 0 | 41,113 |
Inventory reserve | 175,000 | 0 |
Revaluation of derivative liabilities | 8,848,953 | 363,919 |
Depreciation | 15,074 | 5,161 |
Changes in operating assets and liabilities: | ||
Restricted cash | 220,586 | -220,586 |
Trade receivables | -85,412 | -2,279 |
Inventories | -558,008 | -80,021 |
Prepaid expenses and other current assets | 72,958 | -195,350 |
Accounts payable | 8,055 | 10,560 |
Accrued expenses and accrued interest | 522,995 | 448,747 |
Accrued interest, related parties | 0 | -16,175 |
Deferred revenue | 46,324 | 0 |
Deferred rent | -5,201 | -4,927 |
Net cash used in operating activities | -6,320,819 | -3,618,532 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of equipment | -25,402 | -35,683 |
Net cash used in investing activities | -25,402 | -35,683 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from senior convertible notes, net | 0 | 686,250 |
Proceeds from senior convertible notes, related party, net | 0 | 686,250 |
Proceeds from Series C-1 preferred stock, net | 0 | 1,463,439 |
Proceeds from Series C-2 preferred stock, related party, net | 0 | 1,463,439 |
Proceeds from Series C-3 preferred stock, net | 743,884 | 0 |
Proceeds from Series C-3 preferred stock, related party | 575,000 | 0 |
Proceeds from exercise of warrants | 0 | 60,000 |
Proceeds from exercise of stock options | 318,150 | 2,400 |
Payments for deferred financing costs | -2,366 | -157,696 |
Proceeds from sale of equity securities | 6,723,248 | 1,033,000 |
Repurchase of outstanding warrants | 0 | -33,000 |
Net cash provided by financing activities | 8,357,916 | 5,204,082 |
Foreign exchange effect on cash | -46,048 | -11,445 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 1,965,647 | 1,538,422 |
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR | 2,373,893 | 835,471 |
CASH AND CASH EQUIVALENTS - END OF YEAR | 4,339,540 | 2,373,893 |
Cash paid for interest | 2,074 | 118,064 |
Supplemental Disclosure of Non-Cash Financing Activities: | ||
Conversion of notes payable and accrued interest to common stock, fair value | 0 | 1,768,722 |
Exchange of convertible notes to preferred stock | 0 | 1,119,340 |
Conversion of preferred stock to common stock | 2,447,384 | 602,105 |
Conversion of accounts payable and accrued expenses to preferred stock | 645,458 | 0 |
Reclassification of derivative liabilities to equity | 17,955,143 | 0 |
Settlement of accrued dividends with issuance of preferred stock | 102,845 | 0 |
Conversion of wages and fees to common stock | 96,851 | 0 |
Dividend, including beneficial conversion feature | 82,899 | 384,307 |
Accrued deferred financing costs | $0 | $2,366 |
1_Organization_Business_and_Ba
1. Organization, Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2014 | |
Organization Business And Basis Of Presentation | |
Organization, Business and Basis of Presentation | Organization and Business: |
CorMedix Inc. (“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. The Company seeks to in-license, develop and commercialize prophylactic and therapeutic products for the prevention and treatment of infectious diseases in cardiac, renal and oncology patients. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH. The Company has in-licensed all of the product candidates in its pipeline. | |
The Company’s primary activities since incorporation have been organizational activities, including recruiting personnel, establishing office facilities, acquiring licenses for its pharmaceutical product candidates, performing business and financial planning, performing research and development, seeking regulatory approval for its products, and raising funds through the issuance of debt and equity securities. | |
The Company received CE Mark approval for Neutrolin in 2013 and began the commercial launch of Neutrolin in Germany for the prevention of catheter-related bloodstream infections, or CRBI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in Austria, Germany, Italy, Malta, Saudi Arabia and The Netherlands for such treatment. | |
In December 2014, the Company received approval from the Hessian District President in Germany to expand the label to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral, or IV, nutrition was also approved. In September 2014, the TUV-SUD and The Medicinal Evaluation Board of the Netherlands (MEB) granted a label expansion for Neutrolin for these same expanded indications for the E.U. | |
2_Liquidity_and_Going_Concern
2. Liquidity and Going Concern | 12 Months Ended |
Dec. 31, 2014 | |
Liquidity And Going Concern | |
Liquidity and going concern | 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 December 31, 2014, the Company has an accumulated deficit of $76.2 million, has incurred an operating loss of $8.9 million and a net loss of $20.5 million for the year then ended. |
Management believes that the Company’s existing cash at December 31, 2014 will be sufficient to meet the Company’s operating needs and fund limited research and development into the third quarter of 2015, after giving effect to the receipt of approximately $2 million from the exercises of warrants and stock options subsequent to year end and the $2.5 million of availability under the "Backstop Agreement" (See Note 12). The Company’s continued operations will depend on whether it is able to generate substantial revenue from the sale of Neutrolin and on its ability to raise additional capital through various 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 that such financing or strategic relationships will be available on acceptable terms, or at all. 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 FDA approval of Neutrolin in the U.S. These and other factors raise substantial doubt about the Company’s ability to continue as a going concern. | |
The financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that might result should the Company be unable to continue as a going concern. |
3_Summary_of_Significant_Accou
3. Summary of Significant Accounting Policies | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accounting Policies [Abstract] | |||||||||
Summary of Significant Accounting Policies | Significant Risks and Uncertainties | ||||||||
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 products, the Company’s 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. | |||||||||
Use of Estimates: | |||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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. | |||||||||
Basis of Consolidation: | |||||||||
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. | |||||||||
Cash and Cash Equivalents: | |||||||||
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 deposit and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. | |||||||||
Foreign Currency: | |||||||||
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, if any, 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 loss. | |||||||||
Geographic Information: | |||||||||
The Company reported revenues of $189,274 and $2,001 for the years ended December 31, 2014 and 2013, respectively. Of the Company’s 2014 revenue, $185,598 was attributable to its European and Mideast operations which are based in Germany. All of the Company’s 2013 revenue was attributable to its European operations. Total assets at December 31, 2014 and 2013 were $5,097,762 and $2,967,801, respectively, of which $4,416,074 and $2,826,274 were located in the United States at December 31, 2014 and 2013, respectively, with the remainders in Germany. Net property and equipment at December 31, 2014 and 2013 were $41,458 and $36,061, respectively, of which $1,089 and $2,497 was located in the United States at December 31, 2014 and 2013, respectively, with the remainders located in Germany. | |||||||||
Restricted Cash: | |||||||||
As of December 31, 2014, the Company has no restricted cash. During the year ended December 31, 2013, the Company invested in a twelve-month 0.14% certificate of deposit held by the bank as collateral for a letter of credit in connection with the Company’s purchase of raw materials due to be delivered in the next twelve months. The certificate of deposit terminated without penalties once the transaction covered by the letter of credit was completed. The certificate of deposit is recorded on the consolidated balance sheet as restricted cash. | |||||||||
Prepaid Expenses: | |||||||||
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. | |||||||||
Inventories, net: | |||||||||
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: | |||||||||
December 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Raw materials | $ | 293,976 | $ | 77,103 | |||||
Work in process | 166,807 | - | |||||||
Finished goods | 2,246 | 2,918 | |||||||
Total | $ | 463,029 | $ | 80,021 | |||||
The Company has an inventory reserve of $175,000 and $0 at December 31, 2014 and 2013, respectively. | |||||||||
Property and Equipment: | |||||||||
Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment which are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. Property and equipment, as of December 31, 2014 and 2013 were $41,458 and $36,061, respectively, net of accumulated depreciation of $77,277 and $62,283, respectively. Depreciation and amortization of property and equipment is included in selling, general and administrative expenses. | |||||||||
Description | Estimated Useful Life | ||||||||
Office equipment and furniture | 5 years | ||||||||
Leasehold improvements | 5 years | ||||||||
Computer equipment | 5 years | ||||||||
Computer software | 3 years | ||||||||
Accrued Expenses: | |||||||||
Accrued expenses consist of the following at December 31: | |||||||||
2014 | 2013 | ||||||||
Licensing fee | $ | - | $ | 500,000 | |||||
Royalty fee | 10,000 | - | |||||||
Accrued payroll and payroll taxes | 13,393 | 197,969 | |||||||
Professional and consulting fees | 225,726 | 12,000 | |||||||
Market research | 137,345 | - | |||||||
Monitoring program fees | 82,861 | - | |||||||
Other | 52,200 | 3,210 | |||||||
Total | $ | 521,525 | $ | 713,179 | |||||
Deferred Revenue: | |||||||||
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. | |||||||||
Revenue Recognition: | |||||||||
CorMedix 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. | |||||||||
CorMedix’s product Neutrolin received its CE Mark in Europe in July 2013 and product shipments to dialysis centers began in December 2013. Orders are processed through a distributor; however, Neutrolin is drop-shipped via a pharmacy directly to the Company’s customer, the dialysis center. The Company recognizes net sales upon shipment of product to the dialysis centers. | |||||||||
Stock-Based Compensation: | |||||||||
The Company accounts for stock options 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, and is recognized as expense net of expected forfeitures, over the employee’s requisite service period on a straight-line basis. | |||||||||
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. 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. | |||||||||
For the purpose of valuing options and warrants granted to directors, officers, employees and consultants, the Company used the Black-Scholes option pricing model. For the purpose of valuing performance based options granted to non-employees, the Company uses the guidelines in accordance with FASB ASC No. 505-50 (“ASC 505”), “Equity-Based Payments to Non-Employees.” The non-cash charge to operations for non-employee options with performance based vesting provisions is recorded when the achievement of the performance condition is probable to be achieved which is typically when the performance condition is satisfied. | |||||||||
Valuations incorporate several variables, including expected term, expected volatility, expected dividend yield and a risk-free interest rate. The Company estimates the expected term of the options granted based on anticipated exercises in future periods. The expected stock price volatility for our stock options is calculated by examining historical volatilities for publicly traded industry peers, since the Company has limited trading history for its common stock. The Company will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for its common stock becomes available. The expected dividend yield reflects our current and expected future policy for dividends on its common stock. To determine the risk-free interest rate, the Company utilizes the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of its awards. | |||||||||
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 our 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 its historical forfeitures. | |||||||||
The Company records compensation expense associated with stock options and other forms of equity compensation using the Black-Scholes option-pricing model and the following assumptions: | |||||||||
Year Ended December 31, | |||||||||
2014 | 2013 | ||||||||
Risk-free interest rate | 1.5% - 2.9 | % | 0.34% - 2.88 | % | |||||
Expected volatility | 74% - 113 | % | 86% - 131 | % | |||||
Expected life of options in years | 5 - 10 years | 2 - 10 years | |||||||
Expected dividend yield | 0 | % | 0 | % | |||||
Embedded Derivative Liabilities and Warrant Liabilities: | |||||||||
The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks; however, the Company has several series of preferred stock and warrants that contained embedded derivatives. The Company evaluates all its financial instruments to determine if those instruments or any potential embedded components of those instruments qualify as derivatives that need to be separately accounted for in accordance with FASB ASC 815, “Derivatives and Hedging”. Embedded derivatives satisfying certain criteria are recorded at fair value at issuance and marked-to-market at each balance sheet date with the change in the fair value recorded as income or expense. In addition, upon the occurrence of an event that requires the derivative liability to be reclassified to equity, the derivative liability is revalued to fair value at that date. | |||||||||
The Company accounts for stock warrants as either equity instruments or derivative liabilities depending on the specific terms of the warrant agreement. Stock warrants that allow for cash settlement or provide for certain modifications of the warrant exercise price were accounted for as derivative liabilities. For those liability-classified warrants that have down-round provisions which allow the exercise price to be adjusted as a result of certain future financing transactions, the Company uses level 3 inputs to value those warrants. The estimated fair values of the warrant liabilities with downround protection were determined using a Monte Carlo option pricing model which takes into account the probabilities of certain events occurring over the life of the warrants. The derivative liabilities were adjusted to their estimated fair values at each reporting period, with any decrease or increase in the estimated fair value being recorded in other income (expense). The significant inputs and assumptions are as follows: | |||||||||
Stock price – Due to the historical volatility of the Company’s common stock price, a one month volume-weighted average stock price was used as of each valuation date. | |||||||||
Conversion/redemption strike price – These assumptions incorporate both the initial contractual conversion price as well as subsequent downward adjustments (wherever applicable) based on management’s estimate of the probabilities of additional future financings that would include a stock price or conversion price that is lower than the then existing conversion price. | |||||||||
Volatility – The Company used a weighted average of (i) the historical volatility of the Company’s common stock for approximately five years, (ii) the volatility used for prior period valuations, and (iii) the volatilities of comparable companies (provided by the Company’s management) from the date product approval is received to the various valuation dates. Then, appropriate weights were applied to these data points to arrive at the weighted average historical volatility. | |||||||||
Term – Although the Series C, D and E preferred stocks do not have a specified contracted life, the Company has assumed a five year life from the date of inception for the purpose of the valuations. | |||||||||
Risk-free Rate – The U.S. Treasury Bond Rate with a term approximating the term of the instrument was used as the risk-free interest rate in the valuation. | |||||||||
Credit adjusted discount rate – Management believes that its debt, if rated, would be equivalent to Moody’s C rated bonds or lower. | |||||||||
Dividend rate - Management does not expect to pay any dividends during the term of the hybrid instrument. | |||||||||
As discussed in Note 8, the warrants issued in March 2014, which do not have downround protection, were valued using a Black Scholes option pricing model. | |||||||||
Research and Development: | |||||||||
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. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. 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. | |||||||||
Income Taxes: | |||||||||
Under ASC 740, “Income Taxes” (“ASC 740”), deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized. | |||||||||
Loss Per Common Share: | |||||||||
Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted loss per common share reflect 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. Since the Company has only incurred losses, basic and diluted loss per share are the same. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Series B non-voting preferred stock | 454,546 | 454,546 | |||||||
Series C non-voting preferred stock | 3,290,000 | 2,900,000 | |||||||
Series D non-voting preferred stock | 1,479,240 | 1,148,000 | |||||||
Series E non-voting preferred stock | 2,021,358 | 1,104,280 | |||||||
Shares underlying outstanding warrants | 11,520,762 | 10,422,525 | |||||||
Shares underlying outstanding stock options | 3,664,500 | 3,453,630 | |||||||
Total | 22,430,406 | 19,482,981 | |||||||
Foreign Currency Exchange Transaction Gain (Loss): | |||||||||
The Company has intercompany loans that are in place between the parent company based in New Jersey and its German subsidiary. Effective October 1, 2014, the Company concluded 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 totaling approximately $108,000 gain for the year ended December 31, 2014. | |||||||||
Fair Value Option: | |||||||||
As permitted under FASB ASC 825, Financial Instruments, (“ASC 825”), the Company elected the fair value option to account for its convertible notes that were issued during the year ended December 31, 2012 and matured during the year ended December 31, 2013. ASC 825 requires that the Company record the financial asset or financial liability at fair value rather than at historical cost with changes in fair value recorded in the statement of operations. In addition, it requires that upfront costs and fees related to items for which the fair value option is elected be recognized in earnings as incurred and not deferred. | |||||||||
Accounting Standards Updates: | |||||||||
In May 2014, the FASB issued new guidance related to how an entity should recognize revenue. The guidance specifies that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In addition, the guidance expands the required disclosures related to revenue and cash flows from contracts with customers. The guidance is effective for us beginning in the first quarter of 2017. Early adoption is not permitted and retrospective application is required. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial condition, results of operations and cash flows. | |||||||||
In June 2014, the FASB issued an accounting standard that clarifies the accounting for share-based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The standard requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. The amendments are effective for interim and annual reporting periods beginning after December 15, 2015. Earlier adoption is permitted. The standard may be applied prospectively to all awards granted or modified after the effective date; or retrospectively to all awards with performance targets that are outstanding as of the beginning of the earliest annual period presented in the financial statements and to all new or modified awards thereafter. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial condition, results of operations and cash flows. |
4_Related_Party_Transactions
4. Related Party Transactions | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Related Party Transactions [Abstract] | ||||||||||||||
Related Party Transactions | In January 2014, the following related parties participated in the private placement of Series C-3 preferred stock and warrants to purchase the Company’s common stock at an exercise price of $1.25 per share, which was reduced to $0.90 in September 2014. Each share of Series C-3 preferred stock is convertible into 10 shares of common stock. All terms were the same as the Series C-1 and C-2 preferred stock issued in the October 2013 private placement: | |||||||||||||
Number of Series C-3 Preferred Stock | ||||||||||||||
Number of Warrants | ||||||||||||||
Amount | ||||||||||||||
Former Chairman of the Board | $ | 500,000 | 50,000 | 250,000 | ||||||||||
Gary A. Gelbfish (1) | ||||||||||||||
Randy Milby | CEO and Director | $ | 237,000 | 23,700 | 118,500 | |||||||||
MW Bridges LLC, an entity for which Randy Milby is Managing Partner | $ | 13,000 | 1,300 | 6,500 | ||||||||||
Director and Former Interim CFO | $ | 45,000 | 4,500 | 22,500 | ||||||||||
Steven W. Lefkowitz | ||||||||||||||
Wade Capital Corporation Money Purchase Plan, an entity for which Steven W. Lefkowitz has voting and investment control | $ | 30,000 | 3,000 | 15,000 | ||||||||||
(1) Gary A. Gelbfish resigned effective June 13, 2014 and ceased to be a related party 90 days thereafter. | ||||||||||||||
In each instance, the purchase was on the same terms as all other purchasers in the offerings. The Audit Committee of the Board of Directors approved the purchase by these insiders. |
5_Income_Taxes
5. Income Taxes | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||
Income Taxes | The Company’s U.S. and foreign loss before income taxes are set forth below: | ||||||||||||||||
December 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
United States | $ | (18,653,576 | ) | $ | (8,745,624 | ) | |||||||||||
Foreign | (1,799,851 | ) | (387,474 | ) | |||||||||||||
Total | $ | (20,453,427 | ) | $ | (9,133,098 | ) | |||||||||||
There was no current or deferred income tax provision for the year ended December 31, 2014 or 2013. | |||||||||||||||||
The Company’s deferred tax assets consist of the following: | |||||||||||||||||
December 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Net operating loss carryforwards – Federal | $ | 12,928,000 | $ | 10,957,000 | |||||||||||||
Net operating loss carryforwards – state | 1,531,000 | 1,331,000 | |||||||||||||||
Net operating loss carryforwards –foreign | 655,000 | 116,000 | |||||||||||||||
Capitalized licensing fees | 2,135,000 | 2,361,000 | |||||||||||||||
Convertible debt and warrants | - | 1,106,000 | |||||||||||||||
Stock-based compensation | 1,457,000 | 690,000 | |||||||||||||||
Other | 38,000 | 3,000 | |||||||||||||||
Totals | 18,744,000 | 16,564,000 | |||||||||||||||
Less valuation allowance | (18,744,000 | ) | (16,564,000 | ) | |||||||||||||
Deferred tax assets | $ | - | $ | - | |||||||||||||
At December 31, 2014, the Company had potentially utilizable Federal, state and foreign net operating loss tax carryforwards of approximately $38,023,000, $25,772,000 and $2,183,000, respectively. The net operating loss tax carryforwards will start to expire in 2026 for Federal purposes and 2015 for state purposes. The foreign net operating loss tax carryforwards do not expire. | |||||||||||||||||
The utilization of the Company’s federal and state net operating losses may be subject to a substantial limitation due to the “change of ownership provisions” under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carryforwards before their utilization. | |||||||||||||||||
The Company’s foreign earnings are derived from it’s German subsidiary. The Company does not expect any foreign earnings to be repatriated in the U.S. in the near future. | |||||||||||||||||
The effective tax rate varied from the statutory rate as follows: | |||||||||||||||||
December 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Statutory Federal tax rate | (34.0 | )% | (34.0 | )% | |||||||||||||
State income tax rate (net of Federal) | (0.6 | )% | (4.6 | )% | |||||||||||||
Effect of foreign operations | 0.4 | % | 0.2 | % | |||||||||||||
Non-deductible expenses associated with derivative liabilities | 23.5 | % | - | ||||||||||||||
Other permanent differences | (0.1 | )% | (0.6 | )% | |||||||||||||
Effect of valuation allowance | 10.8 | % | 39 | % | |||||||||||||
Effective tax rate | 0 | % | 0 | % | |||||||||||||
In assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the appropriate character during the periods in which those temporary differences become deductible and the loss carryforwards are available to reduce taxable income. In making its assessment, the Company considered all sources of taxable income including carryback potential, future reversals of existing deferred tax liabilities, prudent and feasible tax planning strategies, and lastly, objectively verifiable projections of future taxable income exclusive of reversing temporary differences and carryforwards. At December 31, 2014 and 2013, the Company maintained a full valuation allowance against its net deferred tax assets. The Company will continue to assess all available evidence during future periods to evaluate the realization of its deferred tax assets. | |||||||||||||||||
The net change in the total valuation allowance for the years ended December 31, 2014 and 2013 was $2,180,000 and $3,031,000, respectively. | |||||||||||||||||
The following table presents the changes in the deferred tax asset valuation allowance for the periods indicated: | |||||||||||||||||
Year Ended | Balance at Beginning of Year | Increase (Decrease) Charged (Credited) to Income Taxes (Benefit) | Increase (Decrease) Charged (Credited) to OCI | Balance at End of Year | |||||||||||||
31-Dec-14 | $ | 16,564,000 | $ | 2,212,000 | $ | (32,000 | ) | $ | 18,744,000 | ||||||||
31-Dec-13 | 13,533,000 | 3,031,000 | - | 16,564,000 | |||||||||||||
Accounting for uncertainty in income taxes requires uncertain tax positions to be classified as non-current income tax liabilities unless they are expected to be paid within one year. The Company has concluded that there are no uncertain tax positions requiring recognition in its consolidated financial statements as of December 31, 2014 and 2013. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. | |||||||||||||||||
The Company files income tax returns in the U.S. federal, state and foreign jurisdictions. Tax years 2011 to 2014 remain open to examination for both the U.S. federal and state jurisdictions. Tax years 2013 and 2014 remain open for Germany. |
6_Commitments_and_Contingencie
6. Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies Disclosure [Abstract] | |||||
Commitments and Contingencies | |||||
Operating Leases: | |||||
On March 18, 2010, the Company entered into a lease agreement with UA Bridgewater Holdings, LLC for office space located in Bridgewater, New Jersey, for an initial term of 60 months, with a commencement date of April 1, 2010, an expiration date of March 31, 2015, and lease payments beginning on July 1, 2010. In accordance with the lease agreement, the Company has deposited $13,342 with the landlord, the equivalent of two months’ rent. The Company has been granted the option to extend the lease term for one additional period of three years, commencing the day following the then-current expiration date of the term, March 31, 2015, provided the Company delivers notice to the landlord no later than nine months prior to March 31, 2015. The Company did not elect to extend the lease term. | |||||
The Company entered into sublease for 4,700 square feet of office space in Bedminster, New Jersey, which sublease runs from April 1, 2015 until March 31, 2018. Rent is $5,000 per month plus occupancy costs such as utilities, maintenance and taxes. In accordance with the lease agreement, the Company has deposited $5,000 with the landlord, the equivalent of one month rent. The Company has occupied the space beginning on March 1, 2015 for which month it is not obligated to pay rent, but must pay occupancy costs. Rent expense for the years ended December 31, 2014 and 2013, was $70,337 and $85,203, respectively. | |||||
The Company’s subsidiary entered into a lease agreement for its offices in Fulda, Germany with ITZ GmbH. The lease has a term of 36 months which commenced on September 1, 2013 for a base monthly payment of €498. The total 36 month lease obligation is approximately €17,900. Additionally, its subsidiary leases its copier pursuant to a lease agreement dated October 10, 2013 with Frima Buromaschinen Schafer GmbH & Co. KG. The lease has a term of 48 months which commenced on November 1, 2013 for a monthly payment of €59. The total 48 month lease obligation is approximately €2,800. | |||||
The Company’s total remaining lease obligation as of December 31, 2014 is set forth below: | |||||
Years Ending December 31, | |||||
2015 | $ | 74,883 | |||
2016 | 66,236 | ||||
2017 | 60,784 | ||||
2018 | 15,000 | ||||
Total | $ | 216,903 | |||
The Company believes that its existing facilities are adequate to meet its current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms. | |||||
Other: | |||||
The Company has entered into various contracts with third parties in connection with the development of the licensed technology described in Note 10. | |||||
In February 2007, Geistlich Söhne AG für Chemische Industrie, Switzerland, or Geistlich, brought an action against the European Sodemann Patent covering our Neutrolin® product candidate which is owned by ND Partners, LLC and licensed to the Company pursuant to the License and Assignment Agreement between the Company and ND Partners LLC. The action that was brought against the counterpart of the Sodemann Patent in Germany at the Board of the European Patent Office opposition division was for lack of inventiveness in the use of citric acid and a pH value in the range of 4.5 to 6.5 with having the aim to provide an alternative lock solution through having improved anticoagulant characteristics compared to the lock solutions of the prior art. The Board of the European Patent Office opposition division rejected the opposition by Geistlich. On August 27, 2008, Geistlich appealed the court's ruling, alleging the same arguments as presented during the opposition proceedings. The Company filed a response to the appeal of Geistlich on March 25, 2009 where it requested a dismissal of the appeal and to maintain the patent as granted. As of March 27, 2014, no further petitions have been filed by ND Partners or Geistlich. On October 10, 2012, the Company became aware that the Board of Appeals of the European Patent Office issued, on September 4, 2012, a summons for oral proceedings. On November 28, 2012, the Board of Appeals of the European Patent Office held oral proceedings and verbally upheld the counterpart of the Sodemann Patent covering Neutrolin®, but remanded the proceeding to the lower court to consider restricting certain of the counterpart of the Sodemann Patent claims. The Company received the Appeals Board final written decision on March 28, 2013 which was consistent with the oral proceedings. In a letter dated September 30, 2013, the Company was notified that the opposition division of the European Patent Office reopened the proceedings before the first instance again, and has given their preliminary non-binding opinion that the patent as amended during the appeal proceedings fulfils the requirements of Clarity, Novelty, and Inventive Step, and invited the parties to provide their comments and/or requests by February 10, 2014. The Company filed its response on February 3, 2014 to request that the patent be maintained as amended during the appeal proceedings. Geistlich did not provide any filing by February 10, 2014; however, the Board of the European Patent Office opposition division has granted Geistlich an extension to respond by the end of July 2014 because its representative did not receive the September 30, 2013 letter due to a change of address. Geistlich did not file a further statement within the required timeline. On November 5, 2014, the Opposition Division at the EPO issued the interlocutory decision to maintain the patent on the basis of the claims as amended during the appeal proceedings. This decision becomes final if no further appeal is lodged by Geistlich by January 15, 2015. As of the date of this report, the Company has not received a communication from the European Patent Office that Geistlich has filed such an appeal. The Company intends to continue to vigorously defend the patent in a restricted form. However, the Company can provide no assurances regarding the outcome of this matter. | |||||
On September 9, 2014, the Company filed in the Mannheim, Germany District Court a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs (the "Defendants") claiming infringement of the Company’s European Patent EP 1 814 562 B1, which was granted by the European Patent Office on January 8, 2014 (the “Prosl European Patent”). The Prosl European Patent covers a low heparin catheter lock solution for maintaining patency and preventing infection in a hemodialysis catheter. In this action, the Company claim that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. The Company believes that its patent is sound, and is seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. An oral hearing in this action was scheduled for and held on January 30, 2015. The date for rendering judgment is scheduled for March 27, 2015. The judgment is subject to appeal. Separately, TauroPharm has filed an opposition with the European Patent Office against the Prosl European Patent alleging that it lacks novelty and inventive step. The Company cannot predict what other defenses the Defendants may raise, or the ultimate outcome of either of these related matters. | |||||
In the same complaint against the same Defendants, the Company also alleged an infringement (requesting the same remedies) of ND Partners’ utility model DE 20 2005 022 124 U1 which is basically identical to the Prosl European Patent in its main aspects and claims. The Mannheim court separated the two proceedings so that the patent and the utility model proceeding are now tried separately and independently from each other due to the slightly differing requirements for both IP rights. An oral hearing with regard to the utility model has been scheduled for March 27, 2015. TauroPharm has filed a cancellation action against the utility model before the German Patent and Trademark Office based on the same arguments as the opposition against the Prosl Patent. The Company cannot predict what other defenses the Defendants may raise, or the ultimate outcome of this matter. | |||||
On January 16, 2015, the Company also filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, the Company allege violation of the German Unfair Competition Act by TauroPharm for the unauthorized use of our proprietary information obtained in confidence by TauroPharm. The Company allege that TauroPharm is improperly and unfairly using its proprietary information relating to the composition and manufacture of its product Neutrolin®, which is approved for sale in Germany, in its manufacture and sale of TauroPharm’s products TauroLockTM, TauroLock-HEP100TM and TauroLock-HEP500TM. The Company seeks a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine as well as citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. A hearing in this matter has been scheduled in the District Court of Cologne for June 18, 2015. | |||||
In the normal course of business, the Company enters into contracts that contain a variety of indemnifications with its employees, licensors, suppliers and service providers. Further, the Company indemnifies its directors and officers who are, or were, serving at the Company’s request in such capacities. The Company does not anticipate recognizing any significant losses relating to these arrangements. |
7_Equity_Instruments_Modificat
7. Equity Instruments Modification and Fair Value Measurements | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Debt Disclosure [Abstract] | |||||||||||||
Equity Instruments Modification and Fair Value Measurements: | The fair value of the Company’s cash, accounts receivable and accounts payable at December 31, 2014 approximate their carrying values due to the relative liquidity and/or short-term nature of these instruments. As defined by ASC Topic 820, “Fair Value Measurements and Disclosures” (“ASC 820”), fair value measurements and disclosures establish a fair value hierarchy that prioritizes fair value measurements based on the type of inputs used for the various valuation techniques (market approach, income approach and cost approach). The three levels of the fair value hierarchy under ASC 820 are described below: | ||||||||||||
● | Level 1 - observable inputs such as quoted prices in active markets for identical assets or liabilities; | ||||||||||||
● | Level 2 - inputs other than quoted market prices that are observable for the asset or liability, either directly or indirectly; these include quoted prices for similar assets or liabilities in active markets, such as interest rates and yield curves that are observable at commonly-quoted intervals; and | ||||||||||||
● | Level 3 - unobservable inputs that reflect the Company’s own assumptions, as there is little, if any, related market activity. | ||||||||||||
The following table presents the fair value hierarchy and the change in fair values of the Company’s derivative liabilities measured at fair value on a recurring basis. | |||||||||||||
Fair Value Hierarchy Level | Fair Value | Change in Fair Value From Jan. 1 to Sept. 15, 2014 (Modification Date) | |||||||||||
31-Dec-13 | |||||||||||||
Series C-1, C-2 and C-3 non-voting preferred stock conversion option issued in October 2013 and January 2014 | 3 | $ | 2,027,330 | $ | 599,814 | ||||||||
Series D non-voting preferred stock conversion option issued in October 2013 | 3 | 901,625 | 2,017,960 | ||||||||||
Series E non-voting preferred stock conversion option issued in October 2013 | 3 | 735,619 | 1,786,902 | ||||||||||
Warrants issued in connection with convertible debt issued in May 2013 | 3 | 660,869 | 1,566,444 | ||||||||||
Warrants issued in connection with Series C-1, C-2 and C-3 non-voting preferred stock issued in October 2013 and January 2014 | 3 | 983,361 | 3,732,962 | ||||||||||
Warrants issued in March 2014 in connection with the private placement of common stock and warrants | 3 | - | (855,129 | ) | |||||||||
Total | $ | 5,308,804 | $ | 8,848,953 | |||||||||
The Company's derivative liabilities are classified as Level 3. Changes in the unobservable input values would likely cause material changes in the fair value of the Company’s Level 3 derivative liabilities. Significant unobservable inputs are implied volatilities. Significant increases (decreases) in implied volatilities in isolation would result in a significantly higher (lower) fair value measurement. The Company reviews these valuations and the changes in the fair value measurements for reasonableness. | |||||||||||||
On September 15, 2014, the Company entered into consent and exchange agreements with the investors holding its outstanding Series C-2 preferred stock and related warrants, Series C-3 preferred stock and related warrants, Series D preferred stock and Series E preferred stock, and the investors holding warrants issued in March 2014. Pursuant to those agreements, the Company and the investors agreed to amend and restate the Series C-2 preferred stock and related warrants, Series C-3 preferred stock and related warrants, Series D preferred stock and Series E preferred stock and the warrants issued in May 2013, October 2013 and March 2014, to remove anti-dilution, price reset, cash settlement features and certain change of control provisions that caused those instruments to be classified as derivative liabilities. The Company also eliminated the preferred dividends on the Series D preferred stock and Series E preferred stock. | |||||||||||||
In exchange for the removal of the anti-dilution, price reset, cash settlement, change of control and dividend provisions from the Series C-2 preferred stock, Series C-3 preferred stock, Series D preferred stock and Series E preferred stock and the related warrants, as applicable, the Company agreed to the following: | |||||||||||||
1. | Decrease the exercise price of the warrants issued in May 2013 from $1.00 to $0.65, decrease the exercise price of the warrants issued in October 2013 from $1.25 to $0.90, decrease the exercise price of the warrants issued in January 2014 from $1.25 to $0.90, and decrease the exercise price of the warrants issued in March 2014 from $3.10 to $2.50; | ||||||||||||
2. | Extend the existing right of the two institutional investors in our May and October 2013 financings to participate in future financings to the later of two years after September 15, 2014 or the date on which the respective holder holds less than 5% of the Company’s common stock on a fully diluted basis; | ||||||||||||
3. | Increase the conversion ratio of the Series E preferred stock from 20 shares to 21.8667 shares of common stock for every share of Series E preferred stock; | ||||||||||||
4. | Issue 16,562 shares of the Company’s Series D preferred stock to the investor holding all of the outstanding shares of the Series D preferred stock in satisfaction of the 9.0% payment-in-kind dividend on that stock; and | ||||||||||||
5. | Issue an aggregate of 37,226 shares of Series E preferred stock to the two investors holding all of the outstanding shares of Series E preferred stock in satisfaction of the 8.0% payment-in-kind dividend on that stock. | ||||||||||||
As a result of these modifications, all of the outstanding derivative liabilities were reclassified to equity. The Company applied the accounting treatment prescribed for the modification of stock options under ASC 718 to the modification of the preferred stock and warrant instruments by analogy. The outstanding warrants and the preferred stock Series E and Series D hybrid instruments were re-measured immediately prior to the modification date with the original terms and immediately after the modification date with the amended terms. The change in fair value resulting from the modifications made to those instruments on September 15, 2014 was recorded as loss on modification of equity instruments and extinguishment of derivative liabilities in the amount of approximately $2,463,000. | |||||||||||||
The table below sets forth a summary of changes in the fair value of the Company’s Level 3 derivative liabilities related to the non-voting preferred stock embedded derivatives and the liability classified warrants. | |||||||||||||
December 31, | |||||||||||||
2014 | |||||||||||||
Balance at beginning of year | $ | 5,308,804 | |||||||||||
Additions to derivative liabilities | 3,782,182 | ||||||||||||
Conversion of convertible preferred stock to common stock | (2,447,384 | ) | |||||||||||
Loss from modification of preferred stock and warrant instruments | 2,462,588 | ||||||||||||
Change in fair value of derivative liabilities | 8,848,953 | ||||||||||||
Reclassification of derivative liabilities to equity (excluding $21,117 dividends issued in 2013) | (17,955,143 | ) | |||||||||||
Balance at end of year | $ | - |
8_Stockholders_Equity_Deficien
8. Stockholders' Equity (Deficiency) | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||
STOCKHOLDERS' DEFICIT | |||||||||||||||||||||||||
Stockholders' Equity (Deficiency) | Common Stock and Warrants: | ||||||||||||||||||||||||
During the year ended December 31, 2013, 9% senior convertible notes in the aggregate principal amount of $924,000 were converted at a conversion price of $0.35 per share resulting in the issuance of an aggregate 2,640,000 shares of the Company’s common stock. | |||||||||||||||||||||||||
During the year ended December 31, 2013, the Series A non-voting convertible preferred stock was converted into 761,429 shares of the Company’s common stock. | |||||||||||||||||||||||||
During the year ended December 31, 2013, warrants to purchase 150,000 shares of the Company’s common stock were exercised resulting in gross proceeds of $60,000 to the Company. | |||||||||||||||||||||||||
During the year ended December 31, 2013, warrants to purchase 890,413 shares of the Company’s common stock were exercised on a cashless basis resulting in the issuance of 527,754 shares of common stock. | |||||||||||||||||||||||||
During the year ended December 31, 2013, a portion of 8% senior convertible note in the principal amount of $750,000 was converted into common shares and interest in the aggregate amount of $36,313 which was paid in common shares resulting in the issuance of an aggregate 1,009,238 shares of the Company’s common stock. | |||||||||||||||||||||||||
In December 2013, 10,000 shares of the Series C-1 preferred stock were converted into 100,000 shares of the Company’s common stock. | |||||||||||||||||||||||||
In March 2014, the Company sold an aggregate of 2,960,000 units in a registered direct offering at a purchase price of $2.50 per unit. Each unit consisted of one share of the Company’s common stock and 0.35 of a warrant, each to purchase one share of the Company’s common stock. Upon issuance, the warrants had an exercise price of $3.10 per share, are exercisable commencing six months from the date of issuance, and have a term of five years from the date of exercisability. A holder is prohibited from exercising a warrant if, as a result of such exercise, the holder, together with its affiliates, would own more than 3.99% or 4.99%, at the holder’s election, of the total number of shares of the Company’s common stock then issued and outstanding. The Company received net proceeds of $6,723,248. Under certain circumstances, the warrants may be settled in cash and were therefore were initially classified as derivative liabilities (See Note 7). The Company used the Black Scholes option pricing model to value the warrants, of which $1,728,450 was the ascribed value calculated at the issuance date. These warrants were revalued at each balance sheet date and the resulting changes were recorded in other income (expense) in the statement of operations. On September 15, 2014, the exercise price of these warrants was decreased to $2.50 in exchange for the removal of the cash settlement provisions of the warrant. The Company revalued the warrants on September 15, 2014 immediately prior to the modification which resulted in a change in fair value recorded in other income (expense) in the statement of operations, and immediately subsequent to the modification which resulted in a loss on modification of equity instruments and extinguishment of derivative liabilities recorded in other income (expense) in the statement of operations. During 2014, the Company used the following assumptions in calculating the Black Scholes values of these warrants: | |||||||||||||||||||||||||
At Issuance Date | At September 15, 2014 | ||||||||||||||||||||||||
Expected term (years) | 5.5 | 5 | |||||||||||||||||||||||
Volatility | 75 | % | 75 | % | |||||||||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||||||||||
Risk-free interest rate | 1.63 | % | 1.8 | % | |||||||||||||||||||||
During the year ended December 31, 2014, stock options to purchase 455,000 shares of the Company’s common stock were exercised resulting in gross proceeds of $318,150 to the Company. | |||||||||||||||||||||||||
During the year ended December 31, 2014, an aggregate of 140,000 shares of the Series C-1 non-voting preferred stock were converted into 1,400,000 shares of the Company’s common stock. | |||||||||||||||||||||||||
During the year ended December 31, 2014, 21,000 shares of the Series C-3 non-voting preferred stock were converted into 210,000 shares of the Company’s common stock. | |||||||||||||||||||||||||
During the year ended December 31, 2014, warrants to purchase 919,513 shares of the Company’s common stock were exercised on a cashless basis resulting in the issuance of 772,589 shares of the Company’s common stock. | |||||||||||||||||||||||||
During the year ended December 31, 2014, wages and board fees in an aggregate amount of $96,851 were converted into 57,384 shares of common stock by an officer and board member at prices of $1.32 - $2.00 per share. | |||||||||||||||||||||||||
During the year ended December 31, 2014, 35,886 shares of common stock held in escrow was released upon achievement of certain milestones. | |||||||||||||||||||||||||
Preferred Stock and Warrants | |||||||||||||||||||||||||
Under the terms of our Amended and Restated Certificate of Incorporation, as amended, our board of directors is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval. Our board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock. Of the 2,000,000 shares of preferred stock authorized, our board of directors has designated (all with par value of $0.001 per share) the following: | |||||||||||||||||||||||||
As of December 31, 2014 | As of December 31, 2013 | ||||||||||||||||||||||||
Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | ||||||||||||||||||||
Series B | 454,546 | $ | 0.001 | 455 | 454,546 | $ | 0.001 | 455 | |||||||||||||||||
Series C-1 | - | 10 | - | 140,000 | 10 | 1,400,000 | |||||||||||||||||||
Series C-2 | 150,000 | 10 | 1,500,000 | 150,000 | 10 | 1,500,000 | |||||||||||||||||||
Series C-3 | 179,000 | 10 | 1,790,000 | - | - | - | |||||||||||||||||||
Series D | 73,962 | 21 | 1,533,202 | 57,400 | 7 | 401,800 | |||||||||||||||||||
Series E | 92,440 | 49.2 | 4,548,048 | 55,214 | 16.4 | 905,510 | |||||||||||||||||||
Total | 949,948 | 9,391,705 | 857,160 | 4,207,765 | |||||||||||||||||||||
On September 15, 2014 the Company entered into consent and exchange agreements with investors holding its outstanding Series C-2, Series C-3, Series D, and Series E non-voting convertible preferred stock. The Company modified certain terms within the preferred stock, as described in Note 7, which resulted in the reclassification of the remaining derivative liability to equity. | |||||||||||||||||||||||||
The Company used a Monte Carlo simulation model to separately value the conversion options associated with the preferred stock instruments and the warrants issued in connection with the preferred stock. A summary of the assumptions used in the Monte Carlo models are as follows: | |||||||||||||||||||||||||
At September 15, 2014 | At Issuance Date | ||||||||||||||||||||||||
Expected term (months) | 49 - 64 | 56 - 60 | |||||||||||||||||||||||
Volatility | 75 | % | 75 | % | |||||||||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||||||||||
Risk-free interest rate | 1.63 - 1.8 | % | 1.3 - 1.5 | % | |||||||||||||||||||||
The following terms and conditions apply to all of the non-voting convertible preferred stock outstanding at December 31, 2014: | |||||||||||||||||||||||||
Dividends - Holders of the Series B, Series C, Series D and Series E non-voting preferred stock are entitled to receive, and the Company is required to pay, dividends on shares of the Series B, Series C, Series D and Series E non-voting preferred stock equal to (on an as-if-converted-to-common-stock basis) and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock. | |||||||||||||||||||||||||
Fundamental Transactions- If, at any time that shares of Series B, Series C, Series D or Series E non-voting preferred stock are outstanding, the Company effects a merger or other change of control transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive, upon any subsequent conversion of a share of Series B, Series C, Series D or Series E non-voting preferred stock (in lieu of conversion shares) for each issuable conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock. | |||||||||||||||||||||||||
Redemption – The Company is not obligated to redeem or repurchase any shares of Series B, Series C, Series D or Series E non-voting preferred stock. Shares of Series B, Series C, series D and Series E Preferred Stock are not otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions. | |||||||||||||||||||||||||
Listing- There is no established public trading market for the Series B, Series C, Series D or Series E non-voting preferred stock, and the Company do not expect a market to develop. In addition, the Company does not intend to apply for listing of the Series B, Series C, Series D or Series E non-voting preferred stock on any national securities exchange or trading system. | |||||||||||||||||||||||||
Series A Non-Voting Convertible Preferred Stock and Warrants | |||||||||||||||||||||||||
On February 19, 2013, the Company sold 761,429 shares of its Series A non-voting convertible preferred stock and a warrant to purchase up to 400,000 shares of the Company’s common stock for gross proceeds of $533,000. The Series A shares and the warrant were sold together at a price of $0.70 per share for each share of Series A stock. Each share of Series A stock was convertible into one share of the Company’s common stock at any time at the holder’s option. However, the holder would be prohibited from converting Series A stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 3.99% of the total number of shares of the Company’s common stock then issued and outstanding. | |||||||||||||||||||||||||
The warrant was exercisable immediately upon issuance and had an exercise price of $1.50 per share and a term of five years. However, the holder would be prohibited from exercising the warrant if, as a result of such exercise, the holder, together with its affiliates, would own more than 3.99% of the total number of shares of the Company’s common stock then issued and outstanding. | |||||||||||||||||||||||||
Because the Series A non-voting preferred stock was immediately convertible at the option of the holder, the Company recorded a deemed dividend of $309,944 from the beneficial conversion feature associated with the issuance of the Series A non-voting convertible preferred stock and the warrant for the year ended December 31, 2013. | |||||||||||||||||||||||||
During the year ended December 31, 2013, all of the Series A non-voting convertible preferred stock was converted into 761,429 shares of common stock. | |||||||||||||||||||||||||
Series B Non-Voting Convertible Preferred Stock and Warrants | |||||||||||||||||||||||||
On July 30, 2013, the Company sold 454,546 shares of its Series B non-voting convertible preferred stock and a warrant to purchase up to 227,273 shares of the Company’s common stock, for gross proceeds of $500,000. The Series B shares and the warrant were sold together at a price of $1.10 per share for each share of Series B stock. Each share of Series B stock is convertible into one share of the Company’s common stock at any time at the holder’s option. However, the holder will be prohibited from converting Series B stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 3.99% of the total number of shares of the Company’s common stock then issued and outstanding. | |||||||||||||||||||||||||
The Series B non-voting preferred stock ranks senior to the Company’s common stock, senior to any class or series of the Company’s capital stock hereafter created specifically ranking by its terms junior to the Series B preferred stock, on parity with the Series C-2 non-voting convertible preferred stock and the Series C-3 non-voting convertible preferred stock and any class or series of the Company’s capital stock hereafter created specifically ranking by its terms on parity with the Series B non-voting convertible preferred stock; and junior to any class or series of the Company’s capital stock hereafter created specifically ranking by its terms senior to the Series B non-voting convertible preferred stock. Shares of Series B non-voting convertible preferred stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series B preferred stock will be required to amend the terms of the Series B non-voting convertible preferred stock or the certificate of designation for the Series B non-voting convertible preferred stock. | |||||||||||||||||||||||||
The warrant was exercisable immediately upon issuance and has an exercise price of $1.50 per share and a term of five years. However, the holder would be prohibited from exercising the warrant if, as a result of such exercise, the holder, together with its affiliates, would own more than 3.99% of the total number of shares of the Company’s common stock then issued and outstanding. | |||||||||||||||||||||||||
Because the Series B non-voting preferred stock was immediately convertible at the option of the holder, the Company recorded a deemed dividend of $53,246 from the beneficial conversion feature associated with the issuance of the Series B non-voting convertible preferred stock and the warrant during the year ended December 31, 2013. | |||||||||||||||||||||||||
Series C-1, Series C-2 and Series C-3 Non-Voting Convertible Preferred Stock and Warrants | |||||||||||||||||||||||||
On October 22, 2013, the Company sold to existing institutional investors 150,000 shares of Series C-1 non-voting convertible preferred stock and 150,000 shares of Series C-2 non-voting convertible preferred stock, together with warrants to purchase up to an aggregate of 1,500,000 shares of common stock, for aggregate gross proceeds of $3,000,000. As a condition to the closing, the Company simultaneously exchanged a convertible note held by one of the investors in the principal amount of $400,000 for 57,400 shares of Series D non-voting convertible preferred stock and exchanged another convertible note held by the same investor in the principal amount of $750,000 for 53,537 shares of Series E non-voting convertible preferred stock. The Company also issued 1,677 shares of Series E preferred stock to the other investor in the offering. | |||||||||||||||||||||||||
The Series C-1 non-voting preferred stock and Series C-2 non-voting preferred stock have identical rights, privileges and terms and are referred to collectively as the “Series C Stock.” Each share of Series C Stock is convertible into 10 shares of common stock at any time at the holder’s option at a conversion price of $1.00 per share. However, the holder will be prohibited from converting Series C Stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution, or winding up, holders of the Series C Stock will receive a payment equal to $10.00 per share of Series C Stock, subject to adjustment, before any proceeds are distributed to the holders of common stock. Shares of the Series C Stock will not be entitled to receive any dividends, unless and until specifically declared by the Company’s board of directors. | |||||||||||||||||||||||||
Due to the existence of downround provisions, both the conversion features of the Series C Stock and the associated warrants are liability classified and are valued using a Monte Carlo model. On the issuance date, the estimated value of the conversion features and warrants was $1,953,965 and $915,058, respectively, and the fair value of the preferred stock, including additional paid-in capital, net of issuance cost was $57,855 during the year ended December 31, 2013. | |||||||||||||||||||||||||
In January 2014, all 140,000 outstanding shares of Series C-1 non-voting preferred stock were converted into 1,400,000 shares of the Company’s common stock which resulted in the reclassification of the derivative liability to equity in the amount of $2,447,384 for the year ended December 31, 2014. | |||||||||||||||||||||||||
In January 2014, the Company sold to various investors 200,000 shares of Series C-3 non-voting convertible preferred stock, together with warrants to purchase up to an aggregate of 1,000,000 shares of common stock, for aggregate gross proceeds of $2,000,000. The Series C-3 non-voting convertible preferred stock and the related warrants were sold together at a price of $10.00 per share for each share of Series C-3 preferred stock. The Series C-3 non-voting convertible preferred stock has rights, privileges and terms that are identical to the Company’s Series C Stock. Each share of Series C-3 preferred stock is convertible into 10 shares of common stock at any time at the holder’s option. However, the holder is prohibited from converting Series C-3 non-voting convertible preferred stock into shares of common stock if, as a result of such conversion, the holder, together with its affiliates, would own more than 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. The warrants are exercisable one year after issuance, had an exercise price of $1.25 per share (decreased to $0.90 per share in September 2014 – See Note 7), subject to adjustment, and a term of five years from the date they are first exercisable. However, a holder is prohibited from exercising a warrant if, as a result of such exercise, the holder, together with its affiliates, would own more than 4.99% or 9.99%, at the holder’s election, of the total number of shares of the Company’s common stock then issued and outstanding. Included in this financing was the settlement of an aggregate amount of $645,458 in accruals and payables owed to ND Partners, the Company’s CEO for his 2013 salary, and a consultant. The Company received net proceeds of $1,318,884. | |||||||||||||||||||||||||
The Series C-1 non-voting convertible preferred stock that was previously designated has all been converted to shares of common stock during the years ended December 31, 2013 and 2014. The Series C-2 and Series C-3 non-voting preferred stock, referred to collectively as the Series C Preferred Stock, have identical rights, privileges and terms. The Series C Preferred Stock rank senior to the Company’s common stock; senior to any class or series of capital stock created after the issuance of the Series C Preferred Stock; on parity with the Series B non-voting convertible preferred stock; and junior to the Series D non-voting convertible preferred stock and Series E non-voting convertible preferred stock. Shares of Series C Preferred Stock will generally have no voting rights, except as required by law and except that the consent of holders of two thirds of the outstanding Series C-2 and Series C-3 Preferred Stock, respectively, will be required to amend the terms of the Series C-2 and C-3 non-voting convertible preferred stock or the certificate of designation for the Series C-2 and C-3 preferred stock, respectively. As long as any of the Series C-2 Preferred Stock is outstanding, we cannot incur any indebtedness other than indebtedness existing prior to September 15, 2014, trade payables incurred in the ordinary course of business consistent with past practice, and letters of credit incurred in an aggregate amount of $3.0 million at any point in time. | |||||||||||||||||||||||||
Due to the existence of downround provisions, the conversion features of the Series C-3 non-voting convertible preferred stock and the associated warrants were initially classified as derivative liabilities upon issuance and were valued using a Monte Carlo simulation model. On the issuance date, the estimated value of the conversion features and warrants was $1,398,158 and $655,574, respectively. | |||||||||||||||||||||||||
As a result of the Series C-3 non-voting convertible preferred financing in January 2014, the anti-dilution provisions of the 8% senior convertible notes and the warrants issued with them caused the conversion price of the 8% senior convertible notes and the exercise price of the warrants to decrease from $1.10 to $1.00. | |||||||||||||||||||||||||
In February 2014, the downround protection of Series C-2 and Series C-3 non-voting convertible preferred stock was eliminated as, pursuant to its terms, the closing price of the Company’s common stock was greater than $2.00 for a period of twenty trading days for a consecutive thirty trading day period subsequent to the closing, resulting in the reclassification of the related derivative liability to equity in the amount of $6,235,398 (See Note 7). | |||||||||||||||||||||||||
The Series C-1 non-voting convertible preferred stock, Series C-2 non-voting convertible preferred stock, Series D non-voting convertible preferred stock and Series E non-voting convertible preferred stock all contain a prohibition on its respective conversion (in the case of the Series C-1 and Series C-2, in the aggregate for both series) if, as a result of such conversion, the Company would have issued in each case shares of its common stock in an aggregate amount equal to 3,190,221 shares, which is 20% of the shares of common stock outstanding on October 17, 2013, unless the Company receives the approval of its stockholders for such overage. On February 28, 2014, the shareholders approved the issuance of such overage. | |||||||||||||||||||||||||
Series D Non-Voting Convertible Preferred Stock | |||||||||||||||||||||||||
As described above, the Series D non-voting convertible preferred stock was issued in exchange for the extinguishment of $400,000 of convertible debt and $1,800 of interest which resulted in a loss on extinguishment of $930,708 during the year ended December 31, 2013. | |||||||||||||||||||||||||
Each share of Series D non-voting convertible preferred stock is convertible into 20 shares of common stock (subject to adjustment) at a per share price of $0.35 at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series D non-voting convertible preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution or winding up, holders of Series D non-voting convertible preferred stock originally was to receive a payment equal to $7.00 per share (increased to $21.00 per share in September 2014 – See Note 7) of Series D non-voting convertible preferred stock on parity with the payment of the liquidation preference due the Series E non-voting convertible preferred stock, but before any proceeds are distributed to the holders of common stock, Series B non-voting convertible preferred stock, the Series C-1 non-voting convertible preferred stock and the Series C-2 non-voting convertible preferred stock. Shares of Series D non-voting convertible preferred stock received a dividend of 9% per annum through September 15, 2014 (See Note 7) and are entitled to receive dividends on shares of the Series D non-voting convertible preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock. | |||||||||||||||||||||||||
The Series D non-voting convertible preferred stock ranks senior to the Company’s common stock; senior to any class or series of capital stock created after the issuance of the Series D non-voting convertible preferred stock; senior to the Series B non-voting convertible preferred stock, the Series C-2 non-voting convertible preferred stock and the Series C-3 non-voting convertible preferred stock; and on parity with the Series E non-voting convertible preferred stock. Shares of Series D non-voting convertible preferred stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series D non-voting convertible preferred stock will be required to amend the terms of the Series D non-voting convertible preferred stock or the certificate of designation for the Series D non-voting convertible preferred stock. As long as any of the Series D non-voting convertible preferred stock is outstanding, the Company cannot incur any indebtedness other than indebtedness existing prior to September 15, 2014, trade payables incurred in the ordinary course of business consistent with past practice, and letters of credit incurred in an aggregate amount of $3.0 million at any point in time. | |||||||||||||||||||||||||
In addition to the debt restrictions above, as long as any shares of the Series D non-voting convertible preferred stock are outstanding, the Company cannot, among others things: create, incur, assume or suffer to exist any encumbrances on any of its assets or property; or redeem, purchase or otherwise acquire or pay or declare any dividend or other distribution on any junior securities. | |||||||||||||||||||||||||
Series E Non-Voting Convertible Preferred Stock | |||||||||||||||||||||||||
As described above, the issuance of the Series E non-voting convertible preferred stock in exchange for the extinguishment of convertible debt with a carrying value of $801,231 and $3,000 of accrued interest resulted in a loss on extinguishment of $495,326 during the year ended December 31, 2013. | |||||||||||||||||||||||||
Each share of Series E non-voting convertible preferred stock was originally convertible into 20 shares (increased to 21.8667 per share in September 2014 – See Note 7) of the Company’s common stock (subject to adjustment) at a per share price of $0.82 (reduced to $0.75 per share in September 2014 – See Note 7) at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series E non-voting convertible preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 9.99% of the total number of shares of the Company’s common stock then issued and outstanding. In the event of the Company’s liquidation, dissolution or winding up, holders of Series E preferred stock originally was to receive a payment equal to $16.40 per share (increased to $49.20 per share in September 2014 – See Note 7) of Series E non-voting convertible preferred stock on parity with the payment of the liquidation preference due the Series D non-voting convertible preferred stock, but before any proceeds are distributed to the holders of common stock, Series B non-voting convertible preferred stock, the Series C-1 non-voting convertible preferred stock and the Series C-2 non-voting convertible preferred stock. Shares of Series E non-voting convertible preferred stock received a dividend of 8% per annum through September 15, 2014 (See Note 7) and are entitled to receive dividends on shares of the Series E non-voting convertible preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock) are paid on shares of the common stock. | |||||||||||||||||||||||||
The Series E non-voting convertible preferred stock ranks senior to the Company’s common stock; senior to any class or series of capital stock created after the issuance of the Series E non-voting preferred stock; senior to the Series B non-voting convertible preferred stock, the Series C-2 non-voting convertible preferred stock and the Series C-3 non-voting convertible preferred stock; and on parity with the Series D non-voting convertible preferred stock. Shares of Series E non-voting convertible preferred stock will generally have no voting rights, except as required by law and except that the consent of holders of a majority of the outstanding Series E non-voting convertible preferred stock will be required to amend the terms of the Series E non-voting convertible preferred stock or the certificate of designation for the Series E non-voting convertible preferred stock. As long as any of the Series E non-voting convertible preferred stock is outstanding, the Company cannot incur any indebtedness other than indebtedness existing prior to September 15, 2014, trade payables incurred in the ordinary course of business consistent with past practice, and letters of credit incurred in an aggregate amount of $3.0 million at any point in time. | |||||||||||||||||||||||||
In addition to the debt restrictions above, as long as any of the Series E non-voting convertible preferred stock is outstanding , the Company cannot, among others things: create, incur, assume or suffer to exist any encumbrances on any of our assets or property; redeem, repurchase or pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series D non-voting convertible preferred stock and the Series E non-voting convertible preferred stock); redeem, repurchase or prepay any indebtedness; or engage in any material line of business substantially different from our current lines of business. | |||||||||||||||||||||||||
In the event the Company issues any options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common stock, then the holders of Series E non-voting convertible preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or securities as if the Series E non-voting convertible preferred stock had been converted to common stock. | |||||||||||||||||||||||||
The Company used a Monte Carlo model to separately value the Series C-1, C-2, D and E preferred stock, the conversion options associated with the those preferred stock instruments and the warrants issued in connection with the Series C-1 and C-2 preferred stock. A summary of the key assumptions used in the Monte Carlo models are as follows: | |||||||||||||||||||||||||
Stock price – Due to the historical volatility of the stock price, a 30-day volume-weighted average stock price was used as of each valuation date. | |||||||||||||||||||||||||
Conversion/redemption strike price – These assumptions incorporate both the initial contractual conversion price as well as subsequent downward adjustments based on management’s estimate of the probabilities of additional future financings that would include a stock price or conversion price that is lower than the then existing conversion price. | |||||||||||||||||||||||||
Volatility – The Company used a weighted average of 1) the historical volatility of the stock of CorMedix for approximately three-years, 2) the volatility of the stock of CorMedix after receiving product approval and 3) the volatilities of comparable companies (provided by the management) from the date product approval is received to the various valuation dates. Then, appropriate weights were applied to these data points to arrive at the weighted average historical volatility. The concluded volatility is assumed to remain constant for all the valuation dates. | |||||||||||||||||||||||||
Term – Although the preferred Series C, D and E instruments do not have a specified contracted life, the Company has assumed a five year life from the date of inception for the purpose of the valuations, indicating that these instruments would expire in October 2018 at which point the holder would convert the investments into equity. | |||||||||||||||||||||||||
Risk-free Rate – The US Treasury Bond Rate with a term approximating the term of the instrument was used as the risk-free interest rate in the valuation. | |||||||||||||||||||||||||
Credit adjusted discount rate – Management believes that its debt, if rated, would be equivalent to Moody’s C rated bonds or lower. | |||||||||||||||||||||||||
Dividend rate - Management does not expect to pay any dividends during the term of the hybrid instrument. | |||||||||||||||||||||||||
Common Stock Options: | |||||||||||||||||||||||||
In March 2013, the Company’s board of directors approved the 2013 Stock Incentive Plan (the “2013 Plan”). The 2013 Plan provides for the issuance of equity grants in the form of options, restricted stock, stock awards and other forms of equity compensation. Awards may be made to directors, officers, employees and consultants under the 2013 Plan. An aggregate of 5,000,000 shares of the Company’s common stock is reserved for issuance under the 2013 Plan. | |||||||||||||||||||||||||
In 2006, the Company established a stock incentive plan (the 2006 “Plan”) under which restricted stock, stock options and other awards based on the Company’s common stock could be granted to the Company’s employees, directors, consultants, advisors and other independent contractors. On January 28, 2010, the Company amended and restated the Plan to, among other things, increase the shares of common stock issuable under the 2006 Plan from 925,000 to 2,300,000. No stock options are available for issuance under the 2006 Plan when the 2013 Plan was approved. | |||||||||||||||||||||||||
During the year ended December 31, 2013, the Company granted to its officers and directors, ten-year non-qualified stock options under the 2013 Plan, covering an aggregate of 1,020,000 shares of the Company’s common stock with an exercise price of $0.90 per share. The 310,000 options granted to four directors vest quarterly over two years. The remaining 710,000 options vest upon specified milestones. The Company recorded the pro rata expense for these options during the year ended December 31, 2013. | |||||||||||||||||||||||||
During the year ended December 31, 2013, the Company granted to various non-officer consultants ten-year non-statutory stock options under the 2013 Plan, covering an aggregate of 380,000 shares of the Company’s common stock with an exercise price of $0.90 per share. Of these options, 260,000 vest upon specified performance milestones, and 120,000 options vest in three years. At December 31, 2013, 40,000 of these performance options were forfeited due to non-achievement of performance and 220,000 performance options were achieved. The Company recorded the value of the options on the date the performance was achieved. Additionally, the Company recorded the pro rata expense for the 120,000 options during the nine months ended September 30, 2013. No expense was recognized for the options subject to performance milestones that were not achieved or forfeited at December 31, 2013. | |||||||||||||||||||||||||
In March 2013, the Company’s board of directors amended the vesting schedule of the options granted in December 2012 to various officers and directors of the Company for an aggregate of 765,000 ten-year stock options with an exercise price of $0.68 per share based on the closing price of the Company’s common stock on the date of grant. Given the anticipated final approval for the CE Mark certification for Neutrolin® during the second quarter of 2013, 50% of such options were amended to vest on the date of issuance of the CE Mark certification for Neutrolin® in Europe, if the CE Mark approval was obtained on or before June 30, 2013 (as opposed to March 31, 2013 as previously provided by the board of directors). In June 2013, these options were further modified such that vesting would occur if the CE Mark was issued on or before July 14, 2013 (as opposed to June 30, 2013). During the quarter ended June 30, 2013, the Company reversed the expense recorded related to the previous value of the options and recorded the pro rata expense related to the modified value of these options. The expense was fully amortized through July 5, 2013, the date the CE Mark certification was received. | |||||||||||||||||||||||||
In August 2013, the Company’s board of directors accelerated the vesting of an aggregate of 70,000 unvested options granted to the Company’s former Chief Financial Officer at the time of his departure from the Company. Additionally, the exercise period of his total outstanding options was extended to two years from three months. These modifications resulted in an aggregate expense of $51,079 to the Company. | |||||||||||||||||||||||||
During the year ended December 31, 2013, an aggregate of 237,333 unvested stock options granted to its former Chief Medical Officer under the 2006 Plan were forfeited as a result of his departure from the Company. The Company reversed the recorded expense related to the forfeited stock options during year ended December 31, 2013. | |||||||||||||||||||||||||
During the year ended December 31, 2013, the Company granted to its various consultants, ten-year non-qualified stock options under the 2013 Plan, covering an aggregate of 414,000 shares of the Company’s common stock with an exercise price of $0.90 per share. Of these options, 294,000 vest upon specified performance milestones, and 120,000 options vest in one year. At December 31, 2013, 30,000 of these performance options were forfeited due to non-achievement of performance and 90,000 performance options were achieved. The Company recorded the value of the options on the date the performance was achieved. Additionally, the Company recorded the pro rata expense for the 120,000 options during the year ended December 31, 2013. No expense was recognized for the options subject to performance milestones that were not achieved or forfeited at December 31, 2013. | |||||||||||||||||||||||||
During the year ended December 31, 2014, the Company granted to its officers, directors and employees, ten-year non-qualified stock options under the 2013 Plan, covering an aggregate of 1,185,000 shares, respectively, of the Company’s common stock with exercise prices ranging from $1.80 to $2.79 per share. Of these options, 896,000 vested on the date of grant, 204,000 options vest one year after the grant date, 45,000 options vest two years after the grant date and 25,000 options vest three years after the grant date. The remaining 15,000 options are subject to certain performance milestones which were achieved during the year ended December 31, 2014, resulting in the vesting of 15,000 options in addition to the 896,000 options that vested on the date of grant. | |||||||||||||||||||||||||
During the year ended December 31, 2014, the Company granted to its consultants ten-year non-qualified stock options under the 2013 Plan, covering an aggregate of 396,000 shares, respectively, of the Company’s common stock with exercise prices ranging from $1.40 to $2.24 per share. Of these options, 44,250 vested on the grant date, 18,750 options vest quarterly for a year, 40,000 options vest quarterly for two years from grant date and the remaining 293,000 options are subject to performance milestones. Some of these milestones were achieved at December 31, 2014 which resulted in the vesting of 50,000 options in addition to the 44,250 options that vested on the date of grant. | |||||||||||||||||||||||||
During the years ended December 31, 2014 and 2013, total compensation expense for stock options issued to employees, directors, officers and consultants was $2,168,303 and $1,345,136, respectively, in accordance with ASC 718 and ASC 505 for stock options issued to employees and non-employees. | |||||||||||||||||||||||||
A summary of the Company’s stock options activity under the Plan and related information is as follows: | |||||||||||||||||||||||||
Year Ended | Year Ended | ||||||||||||||||||||||||
31-Dec-14 | 31-Dec-13 | ||||||||||||||||||||||||
Shares | Weighted | Shares | Weighted | ||||||||||||||||||||||
Average | Average | ||||||||||||||||||||||||
Exercise | Exercise | ||||||||||||||||||||||||
Price | Price | ||||||||||||||||||||||||
Outstanding at beginning of year | 3,453,630 | $ | 1.06 | 2,135,630 | $ | 1.26 | |||||||||||||||||||
Granted | 1,581,000 | $ | 1.98 | 1,814,000 | $ | 0.9 | |||||||||||||||||||
Exercised | (455,000 | ) | $ | 0.7 | (10,000 | ) | $ | 0.24 | |||||||||||||||||
Cancelled | (574,630 | ) | $ | 2.65 | (118,667 | ) | $ | 1.61 | |||||||||||||||||
Forfeited | (340,500 | ) | $ | 1.13 | (367,333 | ) | $ | 1.28 | |||||||||||||||||
Outstanding at end of year | 3,664,500 | $ | 1.25 | 3,453,630 | $ | 1.06 | |||||||||||||||||||
Outstanding at end of year expected to vest | 481,835 | $ | 1.25 | 587,278 | $ | 0.9 | |||||||||||||||||||
Options exercisable | 3,092,250 | $ | 1.15 | 2,490,880 | $ | 1.12 | |||||||||||||||||||
Weighted-average fair value of options granted during the year | $ | 1.5 | $ | 0.76 | |||||||||||||||||||||
The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted to consultants is based upon the full term of the respective option agreements. Given the Company’s short period of publicly-traded stock history, management’s estimate of expected volatility is based on the average historical volatilities of a sampling of five companies with similar attributes to the Company, including: industry, stage of life cycle, size and financial leverage. The Company will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for the Company’s common stock becomes available. The expected dividend yield of 0.0% reflects the Company’s current and expected future policy for dividends on the Company’s common stock. To determine the risk-free interest rate, the Company utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of the Company’s awards. 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 the Company’s historical forfeitures. | |||||||||||||||||||||||||
The weighted average remaining contractual life of stock options outstanding at December 31, 2014 and 2013 is 8.2 years and 7.5 years, respectively. The weighted average remaining contractual life of stock options exercisable at December 31, 2014 is 8.0 years. The aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price. The aggregate intrinsic value of all stock options exercised during the year ended December 31, 2014 and 2013 was $636,250 and $6,100, respectively. The aggregate intrinsic value of outstanding stock options at December 31, 2014 and 2013 was $2,659,665 and $1,404,110, respectively. | |||||||||||||||||||||||||
As of December 31, 2014 and 2013 the total compensation expense related to non-vested options not yet recognized totaled $308,005 and $479,182, respectively. The weighted-average vesting period over which the total compensation expense related to non-vested options not yet recognized at December 31, 2014 and 2013 was approximately 0.5 years and 0.9 years, respectively. | |||||||||||||||||||||||||
Warrants: | |||||||||||||||||||||||||
The following table is the summary of warrant activity for the year ended December 31, 2014: | |||||||||||||||||||||||||
Shares | Weighted | Weighted Average Remaining Contractual Life | |||||||||||||||||||||||
Average | |||||||||||||||||||||||||
Exercise | |||||||||||||||||||||||||
Price | |||||||||||||||||||||||||
Outstanding at beginning of period | 10,422,525 | $ | 2 | 3.12 | |||||||||||||||||||||
Granted | 2,036,000 | $ | 2.19 | 5.11 | |||||||||||||||||||||
Expired | (18,250 | ) | - | - | |||||||||||||||||||||
Exercised | (919,513 | ) | $ | 0.41 | - | ||||||||||||||||||||
Outstanding at end of period | 11,520,762 | $ | 1.99 | * | 2.57 | ** | |||||||||||||||||||
* Reflects reduced exercise prices of warrants as per September 15, 2014 amendment, see Note 7. | |||||||||||||||||||||||||
**Reflects extension of the expiration date of 503,034 warrants issued in connection with 2009 private placement from October 29, 2014 to December 31, 2014 then to March 31, 2015. The extension of the expiration dates resulted in deemed dividend attributable to common shareholders of $1,172. | |||||||||||||||||||||||||
Stock-based Deferred Compensation Plan for Non-Employee Directors | |||||||||||||||||||||||||
During the third quarter of 2014, the Company established an unfunded stock-based deferred compensation plan, providing non-employee directors the opportunity to defer up to one hundred percent of fees and compensation, including restricted stock units. The amount of fees and compensation deferred by a non-employee director is converted into stock units, the number of which is determined based on the closing price of the Company’s common stock on the date such compensation would have otherwise been payable. At all times, the plan participants are one hundred percent vested in their respective deferred compensation accounts. On the tenth business day of January in the year following a director’s termination of service, the director will receive a number of common shares equal to the number of stock units accumulated in the director’s deferred compensation account. The Company accounts for this plan as stock based compensation under ASC 718. During the year ended December 31, 2014, the amount of compensation that was deferred under this plan was $21,826. | |||||||||||||||||||||||||
Note 9 — Convertible Notes: | |||||||||||||||||||||||||
On July 5, 2013, the Company received from existing institutional investors net proceeds of $1,372,500 upon approval of a CE Mark certification. The Company had entered into an agreement with existing stockholders in May 2013 for an aggregate principal amount of $1,500,000 of senior secured convertible notes and warrants to purchase up to an aggregate of 1,000,000 shares of its common stock. The receipt of net proceeds of $1,372,500 was dependent upon receipt of a CE Mark certification, which occurred on July 5, 2013. The notes bore interest at the rate of 8.0% per annum and were subject to a “make-whole” upon any conversion of the notes into common stock, as if the notes being converted were outstanding to April 1, 2014. Interest was first payable on September 3, 2013 and was payable on the first trading day of each month thereafter. The notes were to mature on April 1, 2016 unless redeemed prior to that date, subject to amortization, discussed below. A noteholder could elect to have any interest due prior to April 1, 2014 added to the principal amount of a note; thereafter, interest will be paid in cash only. The warrants are exercisable one year after issuance, have an exercise price of $1.10 per share, subject to anti-dilution adjustment, and a term of five years from the date they are first exercisable. The holders of the notes and warrants will be prohibited from converting the notes into or exercising the warrants for shares of common stock if, as a result of such conversion or exercise, the holder, together with its affiliates, would own more than 4.99% or 9.99%, respectively, at the initial holder’s election, of the total number of shares of the Company’s common stock then issued and outstanding. | |||||||||||||||||||||||||
The Company could redeem the notes in cash at par value or in shares of stock which are priced in accordance with a pricing formula set forth in the notes, in eight equal monthly installment payments beginning on September 1, 2013, and continuing thereafter on the first business day of each month, ending on April 1, 2014. At the Company’s option, and if certain equity conditions are waived or satisfied, the Company could elect to pay these installment payments in shares of common stock, in cash, or in any combination of shares and cash. To the extent the Company paid all or any portion of an installment payment in common stock, the Company would deliver to each noteholder the amount of shares equal to the applicable installment payment being paid in shares of common stock, divided by the lower of (i) the conversion price then in effect, and (ii) 90% of the average of the 10 lowest-volume weighted-average prices of our common stock during the 20 trading day period ending two trading days prior to the applicable payment date (the “Company Conversion Price”). | |||||||||||||||||||||||||
All installment payments were subject to the right of each noteholder to defer payment of some or all of any installment payment to a subsequent installment date or the maturity date, and, with respect to any installment date, convert, at the then-prevailing Company Conversion Price, any amount of principal and capitalized interest up to an amount equal to four installment payments. Each noteholder could also convert, at any time, all or a portion of any deferred installment payment. The Company Conversion Price for any such deferred installment payment would be the lower of the Company Conversion Price in effect on the date of the original installment date and the Company Conversion Price then in effect. | |||||||||||||||||||||||||
Due to the complexity and number of embedded features within the convertible note and as permitted under under ASC 825, the Company elected to account for the convertible notes and all the embedded features (collectively, the “hybrid instrument”) under the fair value option. ASC 825 requires the entity to record the financial asset or financial liability at fair value rather than at historical cost with changes in fair value recorded in the statement of operations. In addition, it requires that upfront costs and fees related to items for which the fair value option is elected be recognized in earnings as incurred and not deferred. On the initial measurement date of July 5, 2013, the fair value of the hybrid instrument was estimated at $1,643,500, which was $143,500 higher than the principal amount of $1,500,000. | |||||||||||||||||||||||||
During the year ended December 31, 2013, the Company redeemed the 8% convertible notes in the principal amount of $750,000 and interest in the amount of $3,000 for an aggregate of 53,537 shares of its Series E non-voting preferred stock. Prior to the redemption, the convertible notes were revalued to fair value, resulting in a loss on revaluation of $4,640. The issuance of the 53,537 shares of the Series E non-voting preferred stock in exchange for the convertible notes resulted in a loss on extinguishment of $495,326. Also, during the fourth quarter of 2013, the balance of the convertible note in the principal amount of $298,750 was converted to common stock, resulting in an $8,148 gain from the revaluation of the portion of the note that was converted. The Company recorded $1,459,661 loss on extinguishment of convertible notes related to the conversions and redemptions during the year ended December 31, 2013 and a gain of $44,642 in the change in fair value of the converted amounts between the issuance date and the relevant conversion dates. | |||||||||||||||||||||||||
The Company used a Monte Carlo model to separately value the warrants issued in connection with the convertible notes in order to take into account the possibility of an adjustment to the exercise price associated with new rounds of financing in the future. The most likely exercise price of the warrants was estimated under various stock price scenarios and the noteholders’ payoffs were computed under each scenario. The present value of the mean of such payoffs represents the value of the warrant on any given valuation date. When the stock price was simulated in the model, the possible scenarios were always between the valuation date stock price and the initial exercise price of $1.10. As a result, the Company estimated the fair value of the warrant liability on the issuance date to be $587,600. | |||||||||||||||||||||||||
A summary of the key assumptions used by the Company in the Monte Carlo simulation model to value the hybrid instrument at each of the relevant measurement dates during the year is as follows: | |||||||||||||||||||||||||
Stock price – Due to the historical volatility of the stock price, a 30-day volume-weighted average stock price was used as of each valuation date. | |||||||||||||||||||||||||
Conversion/redemption strike price – These assumptions incorporate both the initial contractual conversion price as well as subsequent downward adjustments based on management’s estimate of the probabilities of additional future financings that would include a stock price or conversion price that is lower than the then existing conversion price. | |||||||||||||||||||||||||
Volatility – Given that the Company recently received CE Mark approval for Neutrolin, the volatility used in the analysis was a weighted average of 1) the Company’s historical volatility, 2) the Company’s volatility after the receipt of CE approval and 3) the volatilities of comparable companies following the receipt of product approval. The resulting volatility used in the analysis was 75%. | |||||||||||||||||||||||||
Term – Based on an evaluation of the terms of the agreement, management has assumed that it would be advantageous for the holders of the Convertible Notes to redeem all installments by April 2014 rather than defer them to a later date. | |||||||||||||||||||||||||
Probability of Event of Default or Change in Control – Management has concluded that the probability of a change in control or event of default during the term of the hybrid instrument is only 5%. | |||||||||||||||||||||||||
Risk-free Rate – The US Treasury Bond Rate with a term approximating the term of the instrument was used as the risk-free interest rate in the valuation. | |||||||||||||||||||||||||
Credit adjusted discount rate – Management believes that its debt, if rated, would be equivalent to Moody’s C rated bonds or lower. | |||||||||||||||||||||||||
Dividend rate - Management does not expect to pay any dividends during the term of the hybrid instrument. | |||||||||||||||||||||||||
The following table is a rollforward for the year ended December 31, 2013 of the carrying amount of the convertible notes for which the fair value option was elected: | |||||||||||||||||||||||||
Balance at January 1, 2013 | $ | - | |||||||||||||||||||||||
Issuance of convertible notes | 1,643,500 | ||||||||||||||||||||||||
Conversions and redemptions of convertible notes | (1,598,858 | ) | |||||||||||||||||||||||
Realized gain resulting from change in fair value on converted/redeemed note | (44,642 | ) | |||||||||||||||||||||||
Balance at December 31, 2013 | $ | - | |||||||||||||||||||||||
All of the remaining convertible notes were converted into shares of common stock or the Company’s Series E non-voting convertible preferred stock in the fourth quarter of 2013. | |||||||||||||||||||||||||
The following table is a rollforward for the year ended December 31, 2013 of the carrying amount of the warrant liability that was issued during the year ended December 31, 2013 in connection with the issuance of convertible notes and Series C-1 and Series C-2 non-voting preferred stock. The warrants are accounted for as a derivative liability and are valued using a Monte Carlo simulation model in order to take into account the possibility of adjustments to the exercise price resulting from additional rounds of financing. During the year ended December 31, 2013, there were no exercises of these warrants. | |||||||||||||||||||||||||
Balance at January 1, 2013 | $ | - | |||||||||||||||||||||||
Issuance of warrants | 1,502,658 | ||||||||||||||||||||||||
Unrealized loss resulting from change in fair value | 141,573 | ||||||||||||||||||||||||
Balance at December 31, 2013 | $ | 1,644,231 |
9_Convertible_Notes
9. Convertible Notes | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Convertible Notes | |||||
Convertible Notes | On July 5, 2013, the Company received from existing institutional investors net proceeds of $1,372,500 upon approval of a CE Mark certification. The Company had entered into an agreement with existing stockholders in May 2013 for an aggregate principal amount of $1,500,000 of senior secured convertible notes and warrants to purchase up to an aggregate of 1,000,000 shares of its common stock. The receipt of net proceeds of $1,372,500 was dependent upon receipt of a CE Mark certification, which occurred on July 5, 2013. The notes bore interest at the rate of 8.0% per annum and were subject to a “make-whole” upon any conversion of the notes into common stock, as if the notes being converted were outstanding to April 1, 2014. Interest was first payable on September 3, 2013 and was payable on the first trading day of each month thereafter. The notes were to mature on April 1, 2016 unless redeemed prior to that date, subject to amortization, discussed below. A noteholder could elect to have any interest due prior to April 1, 2014 added to the principal amount of a note; thereafter, interest will be paid in cash only. The warrants are exercisable one year after issuance, have an exercise price of $1.10 per share, subject to anti-dilution adjustment, and a term of five years from the date they are first exercisable. The holders of the notes and warrants will be prohibited from converting the notes into or exercising the warrants for shares of common stock if, as a result of such conversion or exercise, the holder, together with its affiliates, would own more than 4.99% or 9.99%, respectively, at the initial holder’s election, of the total number of shares of the Company’s common stock then issued and outstanding. | ||||
The Company could redeem the notes in cash at par value or in shares of stock which are priced in accordance with a pricing formula set forth in the notes, in eight equal monthly installment payments beginning on September 1, 2013, and continuing thereafter on the first business day of each month, ending on April 1, 2014. At the Company’s option, and if certain equity conditions are waived or satisfied, the Company could elect to pay these installment payments in shares of common stock, in cash, or in any combination of shares and cash. To the extent the Company paid all or any portion of an installment payment in common stock, the Company would deliver to each noteholder the amount of shares equal to the applicable installment payment being paid in shares of common stock, divided by the lower of (i) the conversion price then in effect, and (ii) 90% of the average of the 10 lowest-volume weighted-average prices of our common stock during the 20 trading day period ending two trading days prior to the applicable payment date (the “Company Conversion Price”). | |||||
All installment payments were subject to the right of each noteholder to defer payment of some or all of any installment payment to a subsequent installment date or the maturity date, and, with respect to any installment date, convert, at the then-prevailing Company Conversion Price, any amount of principal and capitalized interest up to an amount equal to four installment payments. Each noteholder could also convert, at any time, all or a portion of any deferred installment payment. The Company Conversion Price for any such deferred installment payment would be the lower of the Company Conversion Price in effect on the date of the original installment date and the Company Conversion Price then in effect. | |||||
Due to the complexity and number of embedded features within the convertible note and as permitted under under ASC 825, the Company elected to account for the convertible notes and all the embedded features (collectively, the “hybrid instrument”) under the fair value option. ASC 825 requires the entity to record the financial asset or financial liability at fair value rather than at historical cost with changes in fair value recorded in the statement of operations. In addition, it requires that upfront costs and fees related to items for which the fair value option is elected be recognized in earnings as incurred and not deferred. On the initial measurement date of July 5, 2013, the fair value of the hybrid instrument was estimated at $1,643,500, which was $143,500 higher than the principal amount of $1,500,000. | |||||
During the year ended December 31, 2013, the Company redeemed the 8% convertible notes in the principal amount of $750,000 and interest in the amount of $3,000 for an aggregate of 53,537 shares of its Series E non-voting preferred stock. Prior to the redemption, the convertible notes were revalued to fair value, resulting in a loss on revaluation of $4,640. The issuance of the 53,537 shares of the Series E non-voting preferred stock in exchange for the convertible notes resulted in a loss on extinguishment of $495,326. Also, during the fourth quarter of 2013, the balance of the convertible note in the principal amount of $298,750 was converted to common stock, resulting in an $8,148 gain from the revaluation of the portion of the note that was converted. The Company recorded $1,459,661 loss on extinguishment of convertible notes related to the conversions and redemptions during the year ended December 31, 2013 and a gain of $44,642 in the change in fair value of the converted amounts between the issuance date and the relevant conversion dates. | |||||
The Company used a Monte Carlo model to separately value the warrants issued in connection with the convertible notes in order to take into account the possibility of an adjustment to the exercise price associated with new rounds of financing in the future. The most likely exercise price of the warrants was estimated under various stock price scenarios and the noteholders’ payoffs were computed under each scenario. The present value of the mean of such payoffs represents the value of the warrant on any given valuation date. When the stock price was simulated in the model, the possible scenarios were always between the valuation date stock price and the initial exercise price of $1.10. As a result, the Company estimated the fair value of the warrant liability on the issuance date to be $587,600. | |||||
A summary of the key assumptions used by the Company in the Monte Carlo simulation model to value the hybrid instrument at each of the relevant measurement dates during the year is as follows: | |||||
Stock price – Due to the historical volatility of the stock price, a 30-day volume-weighted average stock price was used as of each valuation date. | |||||
Conversion/redemption strike price – These assumptions incorporate both the initial contractual conversion price as well as subsequent downward adjustments based on management’s estimate of the probabilities of additional future financings that would include a stock price or conversion price that is lower than the then existing conversion price. | |||||
Volatility – Given that the Company recently received CE Mark approval for Neutrolin, the volatility used in the analysis was a weighted average of 1) the Company’s historical volatility, 2) the Company’s volatility after the receipt of CE approval and 3) the volatilities of comparable companies following the receipt of product approval. The resulting volatility used in the analysis was 75%. | |||||
Term – Based on an evaluation of the terms of the agreement, management has assumed that it would be advantageous for the holders of the Convertible Notes to redeem all installments by April 2014 rather than defer them to a later date. | |||||
Probability of Event of Default or Change in Control – Management has concluded that the probability of a change in control or event of default during the term of the hybrid instrument is only 5%. | |||||
Risk-free Rate – The US Treasury Bond Rate with a term approximating the term of the instrument was used as the risk-free interest rate in the valuation. | |||||
Credit adjusted discount rate – Management believes that its debt, if rated, would be equivalent to Moody’s C rated bonds or lower. | |||||
Dividend rate - Management does not expect to pay any dividends during the term of the hybrid instrument. | |||||
The following table is a rollforward for the year ended December 31, 2013 of the carrying amount of the convertible notes for which the fair value option was elected: | |||||
Balance at January 1, 2013 | $ | - | |||
Issuance of convertible notes | 1,643,500 | ||||
Conversions and redemptions of convertible notes | (1,598,858 | ) | |||
Realized gain resulting from change in fair value on converted/redeemed note | (44,642 | ) | |||
Balance at December 31, 2013 | $ | - | |||
All of the remaining convertible notes were converted into shares of common stock or the Company’s Series E non-voting convertible preferred stock in the fourth quarter of 2013. | |||||
The following table is a rollforward for the year ended December 31, 2013 of the carrying amount of the warrant liability that was issued during the year ended December 31, 2013 in connection with the issuance of convertible notes and Series C-1 and Series C-2 non-voting preferred stock. The warrants are accounted for as a derivative liability and are valued using a Monte Carlo simulation model in order to take into account the possibility of adjustments to the exercise price resulting from additional rounds of financing. During the year ended December 31, 2013, there were no exercises of these warrants. | |||||
Balance at January 1, 2013 | $ | - | |||
Issuance of warrants | 1,502,658 | ||||
Unrealized loss resulting from change in fair value | 141,573 | ||||
Balance at December 31, 2013 | $ | 1,644,231 |
10_License_and_Other_Agreement
10. License and Other Agreements | 12 Months Ended |
Dec. 31, 2014 | |
License And Other Agreements | |
License and Other Agreements | On January 30, 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with ND Partners LLC, a Delaware limited liability company (“NDP”). Pursuant to the NDP License Agreement, NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications (the “NDP Technology”). The Company acquired such licenses and patents through our assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. NDP also granted the Company exclusive licenses, with the right to grant sublicenses, to use and display certain trademarks in connection with the NDP Technology. As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $325,000 and granted NDP a 5% equity interest in the Company, consisting of 39,980 shares of the Company’s Common Stock. In connection with this stock issuance, the Company recorded $328,948 of research and development expense in 2008. In addition, the Company is required to make payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The Company was also obligated to issue additional shares of common stock to NDP sufficient to maintain its ownership percentage at 5.0% of the outstanding common stock (7.0%, including the escrow shares) on a fully diluted basis, until such time that the Company has raised $25 million through the sale of its equity securities or until an initial public offering, reverse merger or a sale of the Company. As a result of this obligation, in October 2009, the Company issued an additional 28,156 shares to NDP and an additional 11,263 shares into the escrow, at a price of $32.05 per share, in connection with the issuance of shares to Shiva under the Exchange Agreement, and in March 2010 the Company issued an additional 297,398 shares to NDP and an additional 118,288 shares into the escrow, at a price of $3.125 per share, in connection with the Company’s IPO; however, such anti-dilution obligation terminated upon the completion of the IPO. The maximum aggregate number of shares issuable upon achievement of milestones is 145,543 shares. During the year ended December 31, 2014, certain milestone was achieved resulting in the release of 35,886 shares held in escrow. The number of shares held in escrow as of December 31, 2014 is 109,657 shares of common stock. The maximum aggregate amount of cash payments upon achievement of milestones is $3,000,000 with $2,500,000 remaining at December 31, 2014. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval processes and certain worldwide net sales amounts. Through December 31, 2014, no milestone payments have been earned by or paid to NDP. |
On April 11, 2013, the Company entered into an amendment to the NDP License Agreement. Under Article 6 of the NDP License Agreement, the Company was obligated to make a milestone payment of $500,000 to ND Partners upon the first issuance of a CE Marking for a licensed product, which payment was payable to ND Partners within 30 days after such issuance. Pursuant to the terms of the amendment, the Company and ND Partners agreed to delay such milestone payment to a time, to be chosen by the Company, anytime within 12 months after the achievement of such issuance. As consideration for the amendment, the Company issued ND Partners a warrant to purchase 125,000 shares of the Company’s common stock at an exercise price of $1.50 per share. The warrant is exercisable immediately upon issuance and has a term of five years. The warrant contains a cashless exercise feature and standard adjustment features in the event of a stock split, stock dividend, recapitalization or similar events. In January 2014, the Company settled this milestone payment which resulted in the issuance of 50,000 shares of the Company’s Series C-3 non-voting convertible preferred and 250,000 shares issuable upon exercise of warrants at an exercise price of $1.25 per share which was decreased to $0.90 per share in January 2014, as described in Note 7. | |
The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP. | |
On January 30, 2008, the Company also entered into an Exclusive License and Consulting Agreement with Dr. Polaschegg (the “Polaschegg License Agreement”). The Polaschegg License Agreement replaced the original license agreement between NDP and Dr. Polaschegg that the Company was assigned and the Company assumed under the NDP License Agreement. Pursuant to the Polaschegg License Agreement, Dr. Polaschegg granted the Company an exclusive, worldwide license for a certain antimicrobial solution and certain taurolidine treatments and the corresponding United States patent applications (the “Polaschegg Technology”), and agreed to provide the Company with certain consulting services. As consideration for the rights to the Polaschegg Technology, the Company paid Dr. Polaschegg an initial payment of $5,000 and agreed to pay Dr. Polaschegg certain royalty payments ranging from 1% to 3% of the net sales of the Polaschegg Technology. The Polaschegg License Agreement also sets forth certain minimum royalty payments (on an annual basis) to be made to Dr. Polaschegg in connection with the Polaschegg Technology, which payments range from $10,000 to $45,000. As compensation for Dr. Polaschegg’s consulting services to be provided under the Polaschegg License Agreement, Dr. Polaschegg is being paid €200 per hour for services consisting of scientific work and €250 per hour for services consisting of legal work. | |
The Company may terminate the Polaschegg License Agreement with respect to any piece of the Polaschegg Technology upon 60 days notice. If the Polaschegg License Agreement is terminated with respect to any piece of the Polaschegg Technology by either party, all rights with respect to such portion of the Polaschegg Technology will revert to Dr. Polaschegg. | |
During the years ended December 31, 2014 and 2013, the Company expensed $40,000 and $45,000, respectively, in connection with the Polaschegg License Agreement. | |
Navinta LLC, a U.S.-based Active Pharmaceutical Ingredient (“API”) developer, provides API manufacturing (manufactured in India at an FDA-compliant facility) and a Drug Master File for CRMD003, pursuant to a supply agreement dated December 7, 2009 (the “Navinta Agreement”). The Navinta Agreement provides that Navinta supply taurolidine (the API for CRMD003) to the Company on an exclusive worldwide basis in the field of the prevention and treatment of human infection and/or dialysis so long as the Company purchased a minimum of $350,000 of product from Navinta by December 30, 2010, which the Company achieved, and following the Company’s first commercial sale of a product incorporating taurolidine, purchases a minimum of $2,250,000 of product on an annual basis for five years. The Company did not purchase the required amount in 2014 and as a result, lost its exclusive manufacturing rights. The Company is also required to make certain cash payments to Navinta upon the achievement of certain sales-based milestones. The maximum aggregate amount of such payments, assuming achievement of all milestones, is $1,975,000 over five years. The Navinta Agreement expires on March 31, 2015, but may be terminated by either party upon 30 days written notice. | |
On May 9, 2014, the Company entered into an employment agreement, effective March 31, 2014, with its Chief Executive Officer, Randy Milby. Unless renewed pursuant to the terms thereof, the agreement will expire on March 31, 2016. Pursuant to the agreement, the Company must use best efforts to cause Mr. Milby to be elected as a member of its Board of Directors and must include him in the management slate for election as a director at every stockholders meeting during the term of the agreement at which his term as a director would otherwise expire. Mr. Milby will not receive additional compensation for his services as a member of the Companys’s Board of Directors. | |
In exchange for his service as the Company’s Chief Executive Officer, Mr. Milby will receive an annual base salary of $300,000.00, up to 50% of which may be paid in the form of unregistered common stock at the discretion of Mr. Milby and subject to specified limitations. Mr. Milby will be eligible for an annual target bonus, the cash portion of which may equal up to 100% of his base salary then in effect, as determined by our Board or compensation committee. In determining such bonus, our Board or compensation committee will take into consideration the achievement of specified company objectives, predetermined by the Board, and specified personal objectives, predetermined by the Board and Mr. Milby. Mr. Milby’s annual bonus, if any, will be paid in cash or a combination of cash and equity, provided that the equity portion will make up no more than 50% of the value of such annual bonus. | |
If the Company terminates Mr. Milby’s employment for Cause as defined in the agreement, Mr. Milby will be entitled to receive only the accrued compensation due to him as of the date of such termination, all shares of restricted stock then held by him will be forfeited as of such date, and all unexercised options to purchase shares of the Company’s capital stock, whether or not vested, will immediately terminate. If Mr. Milby resigns for other than Good Reason, he will be entitled only to payment of his accrued compensation as of such date. If the Company terminates Mr. Milby’s employment other than for Cause, death or disability, or if Mr. Milby resigns for Good Reason (as each such term is defined below), Mr. Milby will continue to receive his base salary and benefits for a period of 12 months following the effective date of the termination of his employment, or, in the case of benefits, until such time as he receives equivalent coverage and benefits under plans and programs of a subsequent employer. All shares of restricted stock and all unvested options to purchase shares of our capital stock then held by Mr. Milby will be accelerated and deemed to have vested as of the effective date of the termination of his employment. To the extent any of the aforementioned benefits cannot be provided to former employees, the Company will pay Mr. Milby a lump-sum payment in the amount necessary to allow Mr. Milby to purchase the equivalent benefits. Upon a Change of Control of the company (as defined in the agreement), all shares of the company’s restricted stock and all unvested options to purchase shares of the Company’s capital stock then held by Mr. Milby will be accelerated and deemed to have vested as of the date of such Change of Control. | |
On July 21, 2014, the Company appointed Harry O’Grady as its Chief Financial Officer and Dr. Antony Pfaffle as its Chief Scientific Officer and entered into an agreement with each officer that provide the terms of their at will employment. Pursuant to their respective agreements, the Company will pay a base salary of $230,000 to Mr. O’Grady and $200,000 to Dr. Pfaffle. Mr. O’Grady will be eligible to participate in the Company’s Short Term Incentive Plan (“STIP”) beginning January 1, 2015, with a target award opportunity equal to 40% of his base salary. Dr. Pfaffle is eligible to participate in the STIP beginning on his employment date. His 2015 target award opportunity is equal to 30% of his base salary. Pursuant to his employment agreement, the Company also granted Mr. O’Grady an option to purchase 100,000 shares of the Company’s common stock. If either officer’s employment is terminated as a result of his death or disability, the Company will pay him or his estate, as applicable (i) his base salary for 180 days after the termination of his employment, and (ii) additional benefits, if any, as may be provided under applicable employee benefit plans, programs and arrangements of the Company. If the Company terminates either officer’s employment without “cause” (as defined in the employment agreement) or the officer terminates his employment for “good reason” (as defined in the employment agreement), then the Company will (i) pay the officer his then-current salary for 12 months, and (ii) provide the officer such other benefits, if any, as may be provided under applicable employee benefit plans, programs and arrangements of the Company. | |
11_Concentrations
11. Concentrations | 12 Months Ended |
Dec. 31, 2014 | |
Risks and Uncertainties [Abstract] | |
11. Concentrations | During the year ended December 31, 2014, the Company recorded individual sales of $55,000 (29%) in excess of 10% of the Company’s total sales. At December 31, 2014, approximately 68% of net accounts receivable was due from one customer. |
12_Subsequent_Events
12. Subsequent Events | 12 Months Ended | |
Dec. 31, 2014 | ||
Subsequent Events [Abstract] | ||
Subsequent Events | In January 2015, warrants to purchase 1,217,779 shares of the Company’s common stock were exercised on a cashless basis resulting in the issuance of 857,324 shares of common stock. | |
In January and February 2015, 31,500 shares of Series C-3 preferred stock were converted into 315,000 shares of the Company’s common stock. | ||
In February 2015, stock options to purchase 30,000 shares of the Company’s common stock were exercised resulting in gross proceeds of $63,000 to the Company. | ||
In January through March 9, 2015, the following warrants were exercised, resulting in aggregate gross proceeds of approximately $2 million to the Company: | ||
● | 125,000 shares of the Company’s common stock with exercise price of $0.90 per share; | |
● | 305,000 shares of the Company’s common stock with exercise price of $2.50 per share; and | |
● | 321,844 shares of the Company’s common stock with exercise prices of $3.4375 per share. | |
On March 3, 2015, the Company entered into a Backstop Agreement with an existing institutional investor, Manchester Securities Corp., an affiliate of Elliott Associates, L.P., pursuant to which Manchester has agreed to lend the Company, at its request, up to $4,500,000 less the dollar amount of gross proceeds received by the Company upon the exercise of warrants to purchase common stock issued in connection with its initial public offering on or before April 30, 2015, provided that the loan may not exceed $3,000,000, due to preferred stock agreement restrictions (See Note 8). The Company may access this financing until April 30, 2015. To access the loan, the Company must meet customary conditions. The loan would bear interest at 6% per annum and would be payable quarterly. The loan would be convertible into common stock of the Company at the lower of a) 80% of the closing price on the day preceding the issuance date of the Note or b) 80% of the average of the seven volume weighted average prices immediately prior to the issuance date of the Note. The loan would mature on April 30, 2020. In consideration for the backstop financing, the Company issued to Manchester a warrant, exercisable for five years, to purchase 200,000 shares of common stock at a per share exercise price of $7.00, and the Company extended by one year to March 24, 2016, the expiration date of a warrant that Manchester holds to purchase 390,720 shares of common stock at a per share exercise price of $3.4375. |
3_Summary_of_Significant_Accou1
3. Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accounting Policies [Abstract] | |||||||||
Use of Estimates | The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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. | ||||||||
Basis of Consolidation | 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. | ||||||||
Cash and Cash Equivalents | 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 deposit and other interest bearing accounts, the balances of which, at times, may exceed federally insured limits. | ||||||||
Foreign Currency | 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, if any, 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 loss. | ||||||||
Geographic Information | The Company reported revenues of $189,274 and $2,001 for the years ended December 31, 2014 and 2013, respectively. Of the Company’s 2014 revenue, $185,598 was attributable to its European and Mideast operations which are based in Germany. All of the Company’s 2013 revenue was attributable to its European operations. Total assets at December 31, 2014 and 2013 were $5,097,762 and $2,967,801, respectively, of which $4,416,074 and $2,826,274 were located in the United States at December 31, 2014 and 2013, respectively, with the remainders in Germany. Net property and equipment at December 31, 2014 and 2013 were $41,458 and $36,061, repectively, of which $1,089 and $2,497 were located in the United States at December 31, 2014 and 2013, respectively, with the remainders located in Germany. | ||||||||
Restricted Cash | As of December 31, 2014, the Company has no restricted cash. During the year ended December 31, 2013, the Company invested in a twelve-month 0.14% certificate of deposit held by the bank as collateral for a letter of credit in connection with the Company’s purchase of raw materials due to be delivered in the next twelve months. The certificate of deposit terminated without penalties once the transaction covered by the letter of credit was completed. The certificate of deposit is recorded on the consolidated balance sheet as restricted cash. | ||||||||
Prepaid Expenses | 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. | ||||||||
Inventories | 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: | ||||||||
31-Dec-14 | 31-Dec-13 | ||||||||
Raw materials | $ | 293,976 | $ | 77,103 | |||||
Work in process | 166,807 | - | |||||||
Finished goods | 2,246 | 2,918 | |||||||
Total | $ | 463,029 | $ | 80,021 | |||||
The Company has an inventory reserve of $175,000 and $0 at December 31, 2014 and 2013, respectively. | |||||||||
Property and Equipment | Property and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment which are recorded at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation of property and equipment is provided for by the straight-line method over the estimated useful lives of the related assets. Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter. Property and equipment, as of December 31, 2014 and 2013 were $41,458 and $36,061, respectively, net of accumulated depreciation of $77,277, and $62,283, respectively. Depreciation and amortization of property and equipment is included in selling, general and administrative expenses. | ||||||||
Description | Estimated Useful Life | ||||||||
Office equipment and furniture | 5 years | ||||||||
Leasehold improvements | 5 years | ||||||||
Computer equipment | 5 years | ||||||||
Computer software | 3 years | ||||||||
Accrued Expenses | Accrued expenses consist of the following at December 31: | ||||||||
2014 | 2013 | ||||||||
Licensing fee | $ | - | $ | 500,000 | |||||
Royalty fee | 10,000 | - | |||||||
Accrued payroll and payroll taxes | 13,393 | 197,969 | |||||||
Professional and consulting fees | 225,726 | 12,000 | |||||||
Market research | 137,345 | - | |||||||
Monitoring program fees | 82,861 | - | |||||||
Other | 52,200 | 3,210 | |||||||
Total | $ | 521,525 | $ | 713,179 | |||||
Deferred Revenue | 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. | ||||||||
Revenue Recognition | CorMedix 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. | ||||||||
CorMedix’s product Neutrolin received its CE Mark in Europe in July 2013 and product shipments to dialysis centers began in December 2013. Orders are processed through a distributor; however, Neutrolin is drop-shipped via a pharmacy directly to the Company’s customer, the dialysis center. The Company recognizes net sales upon shipment of product to the dialysis centers. | |||||||||
Stock-Based Compensation | The Company accounts for stock options 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, and is recognized as expense net of expected forfeitures, over the employee’s requisite service period on a straight-line basis. | ||||||||
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. 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. | |||||||||
For the purpose of valuing options and warrants granted to directors, officers, employees and consultants, the Company used the Black-Scholes option pricing model. For the purpose of valuing performance based options granted to non-employees, the Company uses the guidelines in accordance with FASB ASC No. 505-50 (“ASC 505”), “Equity-Based Payments to Non-Employees.” The non-cash charge to operations for non-employee options with performance based vesting provisions is recorded when the achievement of the performance condition is probable to be achieved which is typically when the performance condition is satisfied. | |||||||||
Valuations incorporate several variables, including expected term, expected volatility, expected dividend yield and a risk-free interest rate. The Company estimates the expected term of the options granted based on anticipated exercises in future periods. The expected stock price volatility for our stock options is calculated by examining historical volatilities for publicly traded industry peers, since the Company has limited trading history for its common stock. The Company will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for its common stock becomes available. The expected dividend yield reflects our current and expected future policy for dividends on its common stock. To determine the risk-free interest rate, the Company utilizes the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of its awards. | |||||||||
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 our 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 its historical forfeitures. | |||||||||
The Company records compensation expense associated with stock options and other forms of equity compensation using the Black-Scholes option-pricing model and the following assumptions: | |||||||||
Year Ended December 31, | |||||||||
2014 | 2013 | ||||||||
Risk-free interest rate | 1.5% - 2.9 | % | 0.34% - 2.88 | % | |||||
Expected volatility | 74% - 113 | % | 86% - 131 | % | |||||
Expected life of options in years | 5 - 10 years | 2 - 10 years | |||||||
Expected dividend yield | 0 | % | 0 | % | |||||
Research and Development | 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. As actual costs become known, the Company adjusts its accruals in the period when actual costs become known. 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. | ||||||||
Income Taxes | Under ASC 740, “Income Taxes” (“ASC 740”), deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. Under ASC 740, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized. | ||||||||
Loss per common share | Basic loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted loss per common share reflect 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. Since the Company has only incurred losses, basic and diluted loss per share are the same. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Series B non-voting preferred stock | 454,546 | 454,546 | |||||||
Series C non-voting preferred stock | 3,290,000 | 2,900,000 | |||||||
Series D non-voting preferred stock | 1,479,240 | 1,148,000 | |||||||
Series E non-voting preferred stock | 2,021,358 | 1,104,280 | |||||||
Shares underlying outstanding warrants | 11,520,762 | 10,422,525 | |||||||
Shares underlying outstanding stock options | 3,664,500 | 3,453,630 | |||||||
Total | 22,430,406 | 19,482,981 | |||||||
Foreign Currency Exchange Transaction Gain (Loss) | The Company has intercompany loans that are in place between the parent company based in New Jersey and its German subsidiary. Effective October 1, 2014, the Company concluded 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 and the translation of the foreign affiliate financial statements to U.S. dollars are recognized in other comprehensive income totaling approximately $108,000 gain for the year ended December 31, 2014. | ||||||||
Fair Value Option | As permitted under FASB ASC 825, Financial Instruments, (“ASC 825”), the Company elected the fair value option to account for its convertible notes that were issued during the year ended December 31, 2012 and matured during the year ended December 31, 2013. ASC 825 requires that the Company record the financial asset or financial liability at fair value rather than at historical cost with changes in fair value recorded in the statement of operations. In addition, it requires that upfront costs and fees related to items for which the fair value option is elected be recognized in earnings as incurred and not deferred. | ||||||||
Accounting Standards Update | In May 2014, the FASB issued new guidance related to how an entity should recognize revenue. The guidance specifies that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. In addition, the guidance expands the required disclosures related to revenue and cash flows from contracts with customers. The guidance is effective for us beginning in the first quarter of 2017. Early adoption is not permitted and retrospective application is required. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial condition, results of operations and cash flows. | ||||||||
In June 2014, the FASB issued an accounting standard that clarifies the accounting for share-based payments when the terms of an award provide that a performance target could be achieved after the requisite service period. The standard requires that a performance target that affects vesting and that could be achieved after the requisite service period be treated as a performance condition. The amendments are effective for interim and annual reporting periods beginning after December 15, 2015. Earlier adoption is permitted. The standard may be applied prospectively to all awards granted or modified after the effective date; or retrospectively to all awards with performance targets that are outstanding as of the beginning of the earliest annual period presented in the financial statements and to all new or modified awards thereafter. The Company is currently evaluating the impact of adopting this guidance on its consolidated financial condition, results of operations and cash flows. | |||||||||
3_Summary_of_Significant_Accou2
3. Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accounting Policies [Abstract] | |||||||||
Inventories | 31-Dec-14 | 31-Dec-13 | |||||||
Raw materials | $ | 293,976 | $ | 77,103 | |||||
Work in process | 166,807 | - | |||||||
Finished goods | 2,246 | 2,918 | |||||||
Total | $ | 463,029 | $ | 80,021 | |||||
Property and Equipment | Description | Estimated Useful Life | |||||||
Office equipment and furniture | 5 years | ||||||||
Leasehold improvements | 5 years | ||||||||
Computer equipment | 5 years | ||||||||
Computer software | 3 years | ||||||||
Accrued Expenses | 2014 | 2013 | |||||||
Licensing fee | $ | - | $ | 500,000 | |||||
Royalty fee | 10,000 | - | |||||||
Accrued payroll and payroll taxes | 13,393 | 197,969 | |||||||
Professional and consulting fees | 225,726 | 12,000 | |||||||
Market research | 137,345 | - | |||||||
Monitoring program fees | 82,861 | - | |||||||
Other | 52,200 | 3,210 | |||||||
Total | $ | 521,525 | $ | 713,179 | |||||
Assumptions for valuation of options | Year Ended December 31, | ||||||||
2014 | 2013 | ||||||||
Risk-free interest rate | 1.5% - 2.9 | % | 0.34% - 2.88 | % | |||||
Expected volatility | 74% - 113 | % | 86% - 131 | % | |||||
Expected life of options in years | 5 - 10 years | 2 - 10 years | |||||||
Expected dividend yield | 0 | % | 0 | % | |||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | December 31, | ||||||||
2014 | 2013 | ||||||||
Series B non-voting preferred stock | 454,546 | 454,546 | |||||||
Series C non-voting preferred stock | 3,290,000 | 2,900,000 | |||||||
Series D non-voting preferred stock | 1,479,240 | 1,148,000 | |||||||
Series E non-voting preferred stock | 2,021,358 | 1,104,280 | |||||||
Shares underlying outstanding warrants | 11,520,762 | 10,422,525 | |||||||
Shares underlying outstanding stock options | 3,664,500 | 3,453,630 | |||||||
Total | 22,430,406 | 19,482,981 |
4_Related_Party_Transactions_T
4. Related Party Transactions (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Related Party Transactions Tables | ||||||||||||||
Related Party Transactions | Number of Series C-3 Preferred Stock | |||||||||||||
Number of Warrants | ||||||||||||||
Amount | ||||||||||||||
Former Chairman of the Board | $ | 500,000 | 50,000 | 250,000 | ||||||||||
Gary A. Gelbfish (1) | ||||||||||||||
Randy Milby | CEO and Director | $ | 237,000 | 23,700 | 118,500 | |||||||||
MW Bridges LLC, an entity for which Randy Milby is Managing Partner | $ | 13,000 | 1,300 | 6,500 | ||||||||||
Director and Former Interim CFO | $ | 45,000 | 4,500 | 22,500 | ||||||||||
Steven W. Lefkowitz | ||||||||||||||
Wade Capital Corporation Money Purchase Plan, an entity for which Steven W. Lefkowitz has voting and investment control | $ | 30,000 | 3,000 | 15,000 |
5_Income_Taxes_Tables
5. Income Taxes (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Income Tax Disclosure [Abstract] | |||||||||||||||||
US and Foreign income | December 31, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
United States | $ | (18,653,576 | ) | $ | (8,745,624 | ) | |||||||||||
Foreign | (1,799,851 | ) | (387,474 | ) | |||||||||||||
Total | $ | (20,453,427 | ) | $ | (9,133,098 | ) | |||||||||||
Deferred Tax Assets | |||||||||||||||||
December 31, | |||||||||||||||||
2014 | 2013 | ||||||||||||||||
Net operating loss carryforwards – Federal | $ | 12,928,000 | $ | 10,957,000 | |||||||||||||
Net operating loss carryforwards – state | 1,531,000 | 1,331,000 | |||||||||||||||
Net operating loss carryforwards –foreign | 655,000 | 116,000 | |||||||||||||||
Capitalized licensing fees | 2,135,000 | 2,361,000 | |||||||||||||||
Convertible debt and warrants | - | 1,106,000 | |||||||||||||||
Stock-based compensation | 1,457,000 | 690,000 | |||||||||||||||
Other | 38,000 | 3,000 | |||||||||||||||
Totals | 18,744,000 | 16,564,000 | |||||||||||||||
Less valuation allowance | (18,744,000 | ) | (16,564,000 | ) | |||||||||||||
Deferred tax assets | $ | - | $ | - | |||||||||||||
Effective Income Tax Rate Reconciliation | December 31, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Statutory Federal tax rate | (34.0 | )% | (34.0 | )% | |||||||||||||
State income tax rate (net of Federal) | (0.6 | )% | (4.6 | )% | |||||||||||||
Effect of foreign operations | 0.4 | % | 0.2 | % | |||||||||||||
Non-deductible expenses associated with derivative liabilities | 23.5 | % | - | ||||||||||||||
Other permanent differences | (0.1 | )% | (0.6 | )% | |||||||||||||
Effect of valuation allowance | 10.8 | % | 39 | % | |||||||||||||
Effective tax rate | 0 | % | 0 | % | |||||||||||||
Changes in deferred tax asset valuation allowance | Year Ended | Balance at Beginning of Year | Increase (Decrease) Charged (Credited) to Income Taxes (Benefit) | Increase (Decrease) Charged (Credited) to OCI | Balance at End of Year | ||||||||||||
31-Dec-14 | $ | 16,564,000 | $ | 2,212,000 | $ | (32,000 | ) | $ | 18,744,000 | ||||||||
31-Dec-13 | 13,533,000 | 3,031,000 | - | 16,564,000 |
6_Commitments_and_Contingencie1
6. Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies Disclosure [Abstract] | |||||
Schedule of Future Minimum Rental Payments for Operating Leases | Years Ending December 31, | ||||
2015 | $ | 74,883 | |||
2016 | 66,236 | ||||
2017 | 60,784 | ||||
2018 | 15,000 | ||||
Total | $ | 216,903 |
7_Equity_Instruments_Modificat1
7. Equity Instruments Modification and Fair Value Measurements (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Convertible Notes | |||||||||||||
Financial Liabilities Measured at Fair Value on a Recurring Basis | Fair Value Hierarchy Level | Fair Value | Change in Fair Value From Jan. 1 to Sept. 15, 2014 (Modification Date) | ||||||||||
31-Dec-13 | |||||||||||||
Series C-1, C-2 and C-3 non-voting preferred stock conversion option issued in October 2013 and January 2014 | 3 | $ | 2,027,330 | $ | 599,814 | ||||||||
Series D non-voting preferred stock conversion option issued in October 2013 | 3 | 901,625 | 2,017,960 | ||||||||||
Series E non-voting preferred stock conversion option issued in October 2013 | 3 | 735,619 | 1,786,902 | ||||||||||
Warrants issued in connection with convertible debt issued in May 2013 | 3 | 660,869 | 1,566,444 | ||||||||||
Warrants issued in connection with Series C-1, C-2 and C-3 non-voting preferred stock issued in October 2013 and January 2014 | 3 | 983,361 | 3,732,962 | ||||||||||
Warrants issued in March 2014 in connection with the private placement of common stock and warrants | 3 | - | (855,129 | ) | |||||||||
Total | $ | 5,308,804 | $ | 8,848,953 | |||||||||
Schedule of changes in fair value | 31-Dec-14 | ||||||||||||
Balance at beginning of year | $ | 5,308,804 | |||||||||||
Additions to derivative liabilities | 3,782,182 | ||||||||||||
Conversion of convertible preferred stock to common stock | (2,447,384 | ) | |||||||||||
Loss from modification of preferred stock and warrant instruments | 2,462,588 | ||||||||||||
Change in fair value of derivative liabilities | 8,848,953 | ||||||||||||
Reclassification of derivative liabilities to equity (excluding $21,117 dividends issued in 2013) | (17,955,143 | ) | |||||||||||
Balance at end of year | $ | - |
8_Stockholders_Equity_Deficien1
8. Stockholders' Equity (Deficiency) (Tables) | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||
STOCKHOLDERS' DEFICIT | |||||||||||||||||||||||||
Fair value assumptions for Black Sholes | At Issuance Date | At September 15, 2014 | |||||||||||||||||||||||
Expected term (years) | 5.5 | 5 | |||||||||||||||||||||||
Volatility | 75 | % | 75 | % | |||||||||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||||||||||
Risk-free interest rate | 1.63 | % | 1.8 | % | |||||||||||||||||||||
Summary of warrants outstanding | As of December 31, 2014 | As of December 31, 2013 | |||||||||||||||||||||||
Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | Preferred Shares Outstanding | Liquidation Preference (Per Share) | Total Liquidation Preference | ||||||||||||||||||||
Series B | 454,546 | $ | 0.001 | 455 | 454,546 | $ | 0.001 | 455 | |||||||||||||||||
Series C-1 | - | 10 | - | 140,000 | 10 | 1,400,000 | |||||||||||||||||||
Series C-2 | 150,000 | 10 | 1,500,000 | 150,000 | 10 | 1,500,000 | |||||||||||||||||||
Series C-3 | 179,000 | 10 | 1,790,000 | - | - | - | |||||||||||||||||||
Series D | 73,962 | 21 | 1,533,202 | 57,400 | 7 | 401,800 | |||||||||||||||||||
Series E | 92,440 | 49.2 | 4,548,048 | 55,214 | 16.4 | 905,510 | |||||||||||||||||||
Total | 949,948 | 9,391,705 | 857,160 | 4,207,765 | |||||||||||||||||||||
Fair value assumptions for Monte Carlo | At September 15, 2014 | At Issuance Date | |||||||||||||||||||||||
Expected term (months) | 49 - 64 | 56 - 60 | |||||||||||||||||||||||
Volatility | 75 | % | 75 | % | |||||||||||||||||||||
Dividend yield | 0 | % | 0 | % | |||||||||||||||||||||
Risk-free interest rate | 1.63 - 1.8 | % | 1.3 - 1.5 | % | |||||||||||||||||||||
Summary of Option Activity under Plan and Related Information | Year Ended | Year Ended | |||||||||||||||||||||||
31-Dec-14 | 31-Dec-13 | ||||||||||||||||||||||||
Shares | Weighted | Shares | Weighted | ||||||||||||||||||||||
Average | Average | ||||||||||||||||||||||||
Exercise | Exercise | ||||||||||||||||||||||||
Price | Price | ||||||||||||||||||||||||
Outstanding at beginning of year | 3,453,630 | $ | 1.06 | 2,135,630 | $ | 1.26 | |||||||||||||||||||
Granted | 1,581,000 | $ | 1.98 | 1,814,000 | $ | 0.9 | |||||||||||||||||||
Exercised | (455,000 | ) | $ | 0.7 | (10,000 | ) | $ | 0.24 | |||||||||||||||||
Cancelled | (574,630 | ) | $ | 2.65 | (118,667 | ) | $ | 1.61 | |||||||||||||||||
Forfeited | (340,500 | ) | $ | 1.13 | (367,333 | ) | $ | 1.28 | |||||||||||||||||
Outstanding at end of year | 3,664,500 | $ | 1.25 | 3,453,630 | $ | 1.06 | |||||||||||||||||||
Outstanding at end of year expected to vest | 481,835 | $ | 1.25 | 587,278 | $ | 0.9 | |||||||||||||||||||
Options exercisable | 3,092,250 | $ | 1.15 | 2,490,880 | $ | 1.12 | |||||||||||||||||||
Weighted-average fair value of options granted during the year | $ | 1.5 | $ | 0.76 | |||||||||||||||||||||
Summary of Warrant Activity | Shares | Weighted | Weighted Average Remaining Contractual Life | ||||||||||||||||||||||
Average | |||||||||||||||||||||||||
Exercise | |||||||||||||||||||||||||
Price | |||||||||||||||||||||||||
Outstanding at beginning of period | 10,422,525 | $ | 2 | 3.12 | |||||||||||||||||||||
Granted | 2,036,000 | $ | 2.19 | 5.11 | |||||||||||||||||||||
Expired | (18,250 | ) | - | - | |||||||||||||||||||||
Exercised | (919,513 | ) | $ | 0.41 | - | ||||||||||||||||||||
Outstanding at end of period | 11,520,762 | $ | 1.99 | * | 2.57 | ** |
9_Convertible_Notes_Tables
9. Convertible Notes (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Convertible Notes Payable [Abstract] | |||||
Schedule of period change for convertible notes | Balance at January 1, 2013 | $ | - | ||
Issuance of convertible notes | 1,643,500 | ||||
Conversions and redemptions of convertible notes | (1,598,858 | ) | |||
Realized gain resulting from change in fair value on converted/redeemed note | (44,642 | ) | |||
Balance at December 31, 2013 | $ | - | |||
Schedule of period change for warrant liability | Balance at January 1, 2013 | $ | - | ||
Issuance of warrants | 1,502,658 | ||||
Unrealized loss resulting from change in fair value | 141,573 | ||||
Balance at December 31, 2013 | $ | 1,644,231 |
3_Summary_of_Significant_Accou3
3. Summary of Significant Accounting Policies (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Summary Of Significant Accounting Policies Details | ||
Raw materials | $293,976 | $77,103 |
Work in process | 166,807 | 0 |
Finished goods | 2,246 | 2,918 |
Total | $463,029 | $80,021 |
3_Summary_of_Significant_Accou4
3. Summary of Significant Accounting Policies (Details 1) | 12 Months Ended |
Dec. 31, 2014 | |
Office equipment and furniture | |
Estimated Useful Life | 5 years |
Leasehold improvements | |
Estimated Useful Life | 5 years |
Computer equipment | |
Estimated Useful Life | 5 years |
Computer software | |
Estimated Useful Life | 3 years |
3_Summary_of_Significant_Accou5
3. Summary of Significant Accounting Policies (Details 2) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Accounting Policies [Abstract] | ||
Licensing fee | $0 | $500,000 |
Royalty fee | 10,000 | 0 |
Accrued payroll and payroll taxes | 13,393 | 197,969 |
Professional and consulting fees | 225,726 | 12,000 |
Market research | 137,345 | 0 |
Monitoring program fees | 82,861 | 0 |
Other | 52,200 | 3,210 |
Total | $521,525 | $713,179 |
3_Summary_of_Significant_Accou6
3. Summary of Significant Accounting Policies (Details 3) (Options and other forms of equity) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Risk-free interest rate, minimum | 1.50% | 0.34% |
Risk-free interest rate, maximum | 2.90% | 2.80% |
Volatility, minimum | 74.00% | 86.00% |
Volatility, maximum | 113.00% | 131.00% |
Dividend yield | 0.00% | 0.00% |
Minimum | ||
Expected Life | 5 years | 2 years |
Maximum | ||
Expected Life | 10 years | 10 years |
3_Summary_of_Significant_Accou7
3. Summary of Significant Accounting Policies (Details 4) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Antidilutive Shares | 22,430,406 | 19,482,981 |
Series B non-voting preferred stock | ||
Antidilutive Shares | 454,546 | 454,546 |
Series C non-voting preferred stock | ||
Antidilutive Shares | 3,290,000 | 2,900,000 |
Series D non-voting preferred stock | ||
Antidilutive Shares | 1,479,240 | 1,148,000 |
Series E non-voting preferred stock | ||
Antidilutive Shares | 2,021,358 | 1,104,280 |
Warrants | ||
Antidilutive Shares | 11,520,762 | 10,422,525 |
Shares underlying outstanding stock options | ||
Antidilutive Shares | 3,664,500 | 3,453,630 |
4_Related_Party_Transactions_D
4. Related Party Transactions (Details) (USD $) | 1 Months Ended |
Jan. 31, 2014 | |
Gary A Gelbfish | |
Description | Former Chairman of the Board |
Amount | $500,000 |
Number of C-3 Preferred Stock | 50,000 |
Number of Warrants | 250,000 |
Randy Milby | |
Description | CEO and Director |
Amount | 237,000 |
Number of C-3 Preferred Stock | 23,700 |
Number of Warrants | 118,500 |
MW Bridges LLC | |
Description | An entity for which Randy Milby is Managing Partner |
Amount | 13,000 |
Number of C-3 Preferred Stock | 1,300 |
Number of Warrants | 6,500 |
Steven W Lefkowitz | |
Description | Director and Former Interim CFO |
Amount | 45,000 |
Number of C-3 Preferred Stock | 4,500 |
Number of Warrants | 22,500 |
Wade Capital Corporation Money Purchase Plan | |
Description | B An entity for which Steven W. Lefkowitz has voting and investment control |
Amount | $30,000 |
Number of C-3 Preferred Stock | 3,000 |
Number of Warrants | 15,000 |
5_Income_Taxes_Details
5. Income Taxes (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Income Loss Before Income Taxes | ($20,453,427) | ($9,133,098) |
United States | ||
Income Loss Before Income Taxes | -18,653,576 | -8,745,624 |
Foreign | ||
Income Loss Before Income Taxes | ($1,799,851) | ($387,474) |
5_Income_Taxes_Details_1
5. Income Taxes (Details 1) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes Details 1 | |||
Net operating loss carryforwardsB bB Federal | $12,928,000 | $10,957,000 | |
Net operating loss carryforwardsB bB state | 1,531,000 | 1,331,000 | |
Net operating loss carryforwards - foreign | 655,000 | 116,000 | |
Capitalized licensing fees | 2,135,000 | 2,361,000 | |
Convertible debt and warrants | 0 | 1,106,000 | |
Stock-based compensation | 1,457,000 | 690,000 | |
Other | 38,000 | 3,000 | |
Totals | 18,744,000 | 16,564,000 | |
Less valuation allowance | -18,744,000 | -16,564,000 | -13,533,000 |
Deferred tax assets | $0 | $0 |
5_Income_Taxes_Details_2
5. Income Taxes (Details 2) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes Details 2 | ||
Statutory Federal tax rate | -34.00% | -34.00% |
State income tax rate (net of Federal) | -0.60% | -4.60% |
Effect of foreign operations | 0.40% | 0.20% |
Non-deductible expenses associated with derivative liabilities | 23.50% | 0.00% |
Other permanent differences | -0.10% | -0.60% |
Effect of valuation allowance | 10.80% | 39.00% |
Effective tax rate | 0.00% | 0.00% |
5_Income_Taxes_Details_3
5. Income Taxes (Details 3) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes Details 3 | ||
Deferred tax asset valuation allowance, beginning | $16,564,000 | $13,533,000 |
Increase (decrease) charged (credited) to income taxes (benefit) | 2,212,000 | 3,031,000 |
Increase (decrease) charged (credited) to OCI | -32,000 | 0 |
Deferred tax asset valuation allowance, end | $18,744,000 | $16,564,000 |
6_Commitments_and_Contingencie2
6. Commitments and Contingencies (Details) (Bridgewater, Bedminster and Fulda Leases, USD $) | Dec. 31, 2014 |
Bridgewater, Bedminster and Fulda Leases | |
2015 | $74,883 |
2016 | 66,236 |
2017 | 60,784 |
2018 | 15,000 |
Total | $216,903 |
6_Commitments_and_Contingencie3
6. Commitments and Contingencies (Details Narrative) (EUR €) | Dec. 31, 2014 |
Fulda office space used by subsidiary | |
Operating lease obligation | € 17,900 |
Copier used by subsidiary | |
Operating lease obligation | € 2,800 |
7_Equity_Instruments_Modificat2
7. Equity Instruments Modification and Fair Value Measurements (Details) (USD $) | 12 Months Ended | 9 Months Ended | |
Dec. 31, 2014 | Sep. 15, 2014 | Dec. 31, 2013 | |
Fair value | $5,308,804 | ||
Change in fair value | 8,848,953 | ||
Series C Non-voting Preferred Stock Conversion Option | |||
Fair value hierarchy level | B 3 | ||
Fair value | 2,027,330 | ||
Change in fair value | 599,814 | ||
Series D Non-voting Preferred Stock Conversion Option | |||
Fair value hierarchy level | 3 | ||
Fair value | 901,625 | ||
Change in fair value | 2,017,960 | ||
Series E Non-voting Preferred Stock Conversion Option | |||
Fair value hierarchy level | 3 | ||
Fair value | 735,619 | ||
Change in fair value | 1,786,902 | ||
Warrants Issued In Connection With Convertible Debt | |||
Fair value hierarchy level | 3 | ||
Fair value | 660,869 | ||
Change in fair value | 1,566,444 | ||
Warrants Issued In Connection With Series C Preferred Stock | |||
Fair value hierarchy level | B 3 | ||
Fair value | 983,361 | ||
Change in fair value | 3,732,962 | ||
Warrants Issued In Connection With Private Placement | |||
Fair value hierarchy level | B 3 | ||
Fair value | 0 | ||
Change in fair value | ($855,129) |
7_Equity_Instruments_Modificat3
7. Equity Instruments Modification and Fair Value Measurements (Details 1) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Equity Instruments Modification And Fair Value Measurements Details 1 | ||
Balance at beginning of period | $5,308,804 | |
Additions to derivative liabilities | 3,782,182 | |
Conversion of convertible preferred stock to common stock | -2,447,384 | |
Loss from modification of preferred stock and warrant instruments | 2,462,588 | 1,459,661 |
Change in fair value of derivative liabilities | 8,848,953 | |
Reclassification of derivative liabilities to equity (excluding $21,117 dividends issued in 2013) | -17,955,143 | |
Balance at end of period | $0 | $5,308,804 |
8_Stockholders_Equity_Details
8. Stockholders' Equity (Details) (Warrants) | 9 Months Ended | 12 Months Ended |
Sep. 15, 2014 | Dec. 31, 2014 | |
Warrants | ||
Expected Term | 5 years | 5 years 6 months |
Volatility | 75.00% | 75.00% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 1.80% | 1.63% |
8_Stockholders_Equity_Details_
8. Stockholders' Equity (Details 1) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Preferred Shares Outstanding | 949,948 | 857,160 |
Total liquidation preference | 9,391,705 | 4,207,765 |
Series B | ||
Preferred Shares Outstanding | 454,546 | 454,546 |
Liquidation Preference (Per Share) | 0.001 | 0.001 |
Total liquidation preference | 455 | 455 |
Series C-1 | ||
Preferred Shares Outstanding | 0 | 140,000 |
Liquidation Preference (Per Share) | 10 | 10 |
Total liquidation preference | 0 | 1,400,000 |
Series C-2 | ||
Preferred Shares Outstanding | 150,000 | 150,000 |
Liquidation Preference (Per Share) | 10 | 10 |
Total liquidation preference | 1,500,000 | 1,500,000 |
Series C-3 | ||
Preferred Shares Outstanding | 179,000 | 0 |
Liquidation Preference (Per Share) | 10 | 0 |
Total liquidation preference | 1,790,000 | 0 |
Series D non-voting preferred stock | ||
Preferred Shares Outstanding | 73,962 | 57,400 |
Liquidation Preference (Per Share) | 21 | 7 |
Total liquidation preference | 1,533,202 | 401,800 |
Series E non-voting preferred stock | ||
Preferred Shares Outstanding | 92,440 | 55,214 |
Liquidation Preference (Per Share) | 49.2 | 16.4 |
Total liquidation preference | 4,548,048 | 905,510 |
8_Stockholders_Equity_Details_1
8. Stockholdersb Equity (Details 2) (Preferred Stock and Warrants) | 0 Months Ended | 9 Months Ended |
Sep. 15, 2014 | Sep. 15, 2014 | |
Volatility | 75.00% | 75.00% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate, minimum | 1.63% | 1.30% |
Risk-free interest rate, maximum | 1.80% | 1.50% |
Minimum | ||
Expected Term | 49 months | 56 months |
Maximum | ||
Expected Term | 64 months | 60 months |
8_Stockholders_Equity_Details_2
8. Stockholders' Equity (Details 3) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Number of Options | ||
Number of Options Outstanding, beginning of year | 3,453,630 | 2,135,630 |
Number of Options Granted | 1,581,000 | 1,814,000 |
Number of Options Exercised | -455,000 | -10,000 |
Number of Options Canceled | -574,630 | -118,667 |
Number of Options Forfeited | -340,500 | -367,333 |
Number of Options Outstanding, at end of year | 3,664,500 | 3,453,630 |
Outstanding at end of year expected to vest | 481,835 | 587,278 |
Options Exercisable | 3,092,250 | 2,490,880 |
Weighted Average Exercise Price | ||
Weighted Average Exercise Price Outstanding, Beginning | $1.06 | $1.26 |
Weighted Average Exercise Price Granted | $1.98 | $0.90 |
Weighted Average Exercise Price Exercised | $0.70 | $0.24 |
Weighted Average Exercise Price Canceled | $2.65 | $1.61 |
Weighted Average Exercise Price Forfeited | $1.13 | $1.28 |
Weighted Average Exercise Price Outstanding, Ending | $1.25 | $1.06 |
Weighted Average Exercise Price expected to vest | $1.25 | $0.90 |
Weighted Average Exercise Price Exercisable | $1.15 | $1.12 |
Aggregate Intrinsic Value | ||
Weighted-average fair value of options granted during the year | $1.50 | $0.76 |
8_Stockholders_Equity_Details_3
8. Stockholders' Equity (Details 4) (USD $) | 12 Months Ended |
Dec. 31, 2014 | |
Stockholders Equity Details 4 | |
Outstanding at beginning of period | $10,422,525 |
Granted | $2,036,000 |
Expired | -18,250 |
Exercised | -919,513 |
Outstanding at end of period | $11,520,762 |
Weighted Average Exercise Price | |
Outstanding at beginning of period | $2 |
Granted | 2.19 |
Expired | 0 |
Exercised | 0.41 |
Outstanding at end of period | $1.99 |
Weighted Average Remaining Contractual Life | |
Outstanding at beginning of period | 3 years 1 month 13 days |
Granted | 5 years 1 month 10 days |
Expired | 0 years |
Exercised | 0 years |
Outstanding at end of period | 2 years 6 months 25 days |
8_Stockholders_Equity_Details_4
8. Stockholdersb Equity (Details Narrative) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Stockholders Equity Details Narrative | ||
Aggregate intrinsic value of outstanding stock options | $2,659,665 | $1,404,110 |
9_Convertible_Notes_Details
9. Convertible Notes (Details) (USD $) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2014 | |
Convertible Notes Details | ||
Balance at January 1, 2013 | $0 | $0 |
Issuance of convertible notes | 1,643,500 | |
Conversions and redemptions of convertible notes | -1,598,858 | |
Realized gain resulting from change in fair value on converted/redeemed note | -44,642 | |
Balance at December 31, 2013 | $0 | $0 |
9_Convertible_Notes_Details_1
9. Convertible Notes (Details 1) (USD $) | 12 Months Ended |
Dec. 31, 2013 | |
Convertible Notes Details 1 | |
Balance at January 1, 2013 | $0 |
Issuance of warrants | 1,502,658 |
Unrealized loss resulting from change in fair value | 141,573 |
Balance at December 31, 2013 | $1,644,231 |