Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2014 | 12-May-14 | |
Document And Entity Information | ' | ' |
Entity Registrant Name | 'CorMedix Inc. | ' |
Entity Central Index Key | '0001410098 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 31-Mar-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
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 Common Stock, Shares Outstanding | ' | 21,993,384 |
Document Fiscal Period Focus | 'Q1 | ' |
Document Fiscal Year Focus | '2014 | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
Current assets | ' | ' |
Cash | $9,189,398 | $2,373,893 |
Restricted cash | 220,662 | 220,586 |
Trade receivables | 14,193 | 2,339 |
Inventories | 63,733 | 80,021 |
Prepaid research and development expenses | 2,438 | 6,205 |
Other prepaid expenses and current assets | 223,995 | 232,987 |
Total current assets | 9,714,419 | 2,916,031 |
Property and equipment, net | 33,574 | 36,061 |
Deferred financing costs | 0 | 2,366 |
Security deposit | 13,342 | 13,342 |
TOTAL ASSETS | 9,761,335 | 2,967,800 |
Current liabilities | ' | ' |
Accounts payable | 1,027,374 | 939,785 |
Accrued expenses | 46,828 | 713,179 |
Dividend payable | 48,268 | 21,117 |
Total current liabilities | 1,122,470 | 1,674,081 |
Derivative liabilities | 12,361,323 | 5,308,804 |
Deferred rent | 6,563 | 7,258 |
TOTAL LIABILITIES | 13,490,356 | 6,990,143 |
COMMITMENTS AND CONTINGENCIES | ' | ' |
STOCKHOLDERS' DEFICIT | ' | ' |
Preferred stock - $0.001 par value:Â Â 2,000,000 shares authorized; 917,160 and 857,160 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively | 917 | 857 |
Common stock - $0.001 par value:Â Â 80,000,000 shares authorized; 21,993,384 and 16,606,695 shares issued and outstanding at March 31, 2014 and December 31, 2013, respectively | 21,993 | 16,606 |
Deferred stock issuances | -146 | -146 |
Accumulated other comprehensive loss | -10,684 | -9,323 |
Additional paid-in capital | 68,749,979 | 51,720,302 |
Deficit accumulated during the development stage | -72,491,080 | -55,750,639 |
TOTAL STOCKHOLDERS' DEFICIENCY | -3,729,021 | -4,022,343 |
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT | $9,761,335 | $2,967,800 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Mar. 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 | 917,160 | 857,160 |
Preferred stock, shares outstanding | 917,160 | 857,160 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 80,000,000 | 80,000,000 |
Common stock, shares issued | 21,993,384 | 16,606,695 |
Common stock, shares outstanding | 21,993,384 | 16,606,695 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations And Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | 92 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | |
REVENUE | ' | ' | ' |
Net sales | $12,203 | $0 | $14,204 |
Cost of sales | -81,026 | 0 | -282,631 |
Gross loss | -68,823 | 0 | -268,427 |
OPERATING EXPENSES | ' | ' | ' |
Research and development | -353,018 | -255,035 | -24,783,196 |
Selling, general and administrative | -2,512,709 | -551,741 | -18,777,660 |
Total Operating Expenses | -2,865,727 | -806,776 | -43,560,856 |
LOSS FROM OPERATIONS | -2,934,550 | -806,776 | -43,829,283 |
OTHER INCOME (EXPENSE) | ' | ' | ' |
Other income, net | -7,638 | 0 | 408,836 |
Interest income | 521 | 128 | 127,496 |
Loss on issuance of convertible notes and warrants | -89,590 | 0 | -1,035,482 |
Change in fair value of convertible notes and warrants | -13,681,569 | 0 | -14,045,488 |
Loss on extinguishment of convertible notes | 0 | 0 | -1,459,661 |
Interest expense, including amortization and write-off of deferred financing costs and debt discounts | -465 | -440,403 | -13,020,815 |
LOSS BEFORE INCOME TAXES | -16,713,291 | -1,247,051 | -72,854,397 |
State income tax benefit | 0 | 0 | 774,775 |
NET LOSS | -16,713,291 | -1,247,051 | -72,079,622 |
OTHER COMPREHENSIVE LOSS | ' | ' | ' |
Foreign currency translation loss | -1,361 | 0 | -10,684 |
COMPREHENSIVE LOSS | -16,714,652 | -1,247,051 | -72,090,306 |
NET LOSS | -16,713,291 | -1,247,051 | -72,079,622 |
Dividends, including beneficial conversion feature | -27,150 | -309,944 | -411,458 |
NET LOSS ATTRIBUTABLE TO COMMON SHAREHOLDERS | ($16,740,441) | ($1,556,995) | ($72,491,080) |
NET LOSS PER SHARE - BASIC AND DILUTED | ($0.87) | ($0.13) | ' |
WEIGHTED AVERAGE SHARES OUTSTANDING - BASIC AND DILUTED | 19,264,884 | 11,603,184 | ' |
Condensed_Consolidated_Shareho
Condensed Consolidated Shareholders Equity (Unaudited) (USD $) | Common Stock | Preferred Stock | Deferred Stock Issuances | Accumulated Other Comprehensive Loss | Additional Paid-In Capital | Accumulated Deficit During Development Stage | Total |
Beginning balance at Dec. 31, 2013 | $16,606 | $857 | ($146) | ($9,323) | $51,720,302 | ($55,750,639) | ($4,022,343) |
Beginning balance (in shares) at Dec. 31, 2013 | 16,606,695 | 857,160 | ' | ' | ' | ' | ' |
Conversion of Series C-1 non-voting preferred stock to common stock (in shares) | 1,400,000 | -140,000 | ' | ' | ' | ' | ' |
Conversion of Series C-1 non-voting preferred stock to common stock | 1,400 | -140 | ' | ' | 2,446,124 | ' | 2,447,384 |
Repurchase of outstanding warrants | ' | ' | ' | ' | ' | ' | 0 |
Stock-based compensation | ' | ' | ' | ' | 1,415,244 | ' | 1,415,244 |
Stock issued in connection with warrants exercised | 752 | ' | ' | ' | -752 | ' | 0 |
Stock issued in connection with warrants exercised (in shares) | 751,689 | ' | ' | ' | ' | ' | ' |
Series C-3 non-voting preferred stock issued in January 2014 financing at $10 per share, net, at fair value | ' | 200 | ' | ' | ' | ' | 200 |
Series C-3 non-voting preferred stock issued in January 2014 financing at $10 per share, net, at fair value (in shares) | ' | 200,000 | ' | ' | ' | ' | ' |
Stock issued in connection with March 2014 public offering at $2.50 per unit, net | 2,960 | ' | ' | ' | 6,720,288 | ' | 6,723,248 |
Stock issued in connection with March 2014 public offering at $2.50 per unit, net (in shares) | 2,960,000 | ' | ' | ' | ' | ' | ' |
Reclassification of preferred stock conversion option from liability to equity | ' | ' | ' | ' | 6,235,398 | ' | 6,235,398 |
Dividends related to Series D and Series E preferred stock | ' | ' | ' | ' | ' | -27,150 | -27,150 |
Stock issued in connection with stock options exercised | 275 | ' | ' | ' | 213,375 | ' | 213,650 |
Stock issued in connection with stock options exercised (in shares) | 275,000 | ' | ' | ' | ' | ' | ' |
Other comprehensive loss | ' | ' | ' | -1,361 | ' | ' | -1,361 |
Net loss | ' | ' | ' | ' | ' | -16,713,291 | -16,713,291 |
Ending balance at Mar. 31, 2014 | $21,993 | $917 | ($146) | ($10,684) | $68,749,979 | ($72,491,080) | ($3,729,021) |
Ending balance (in shares) at Mar. 31, 2014 | 21,993,384 | 917,160 | ' | ' | ' | ' | ' |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 3 Months Ended | 92 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' | ' |
Net loss | ($16,713,291) | ($1,247,051) | ($72,079,622) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Stock-based compensation | 1,415,244 | -17,923 | 5,359,618 |
Stock issued in connection with license agreements | 0 | 0 | 6,613,718 |
Stock issued in connection with consulting agreement | 0 | 0 | 158,262 |
Warrants issued in connection with license agreement | 0 | 0 | 76,574 |
Amortization of deferred financing costs | 0 | 81,396 | 2,407,399 |
Amortization of debt discount | 0 | 328,761 | 6,312,768 |
Loss on foreign currency transactions | 7,638 | 0 | 7,638 |
Loss on issuance of convertible notes, warrants and preferred stock | 89,590 | 0 | 1,035,482 |
Loss on extinguishment of convertible notes | 0 | 0 | 1,459,661 |
Revaluation of derivative liability | 13,681,569 | 0 | 14,045,488 |
Non-cash charge for beneficial conversion feature | 0 | 0 | 1,137,762 |
Non-cash interest expense | 0 | 0 | 3,048,131 |
Expenses paid on behalf of the Company satisfied through the issuance of notes | 0 | 0 | 51,253 |
Depreciation | 2,446 | 543 | 64,649 |
Changes in operating assets and liabilities: | ' | ' | ' |
Restricted cash | -76 | 0 | -220,662 |
Trade receivables | -11,813 | 0 | -14,092 |
Inventory | 16,288 | 0 | -63,733 |
Prepaid expenses and other current assets | 10,456 | -14,074 | -226,792 |
Security deposits | 0 | 0 | -13,342 |
Accounts payable | 117,511 | 262,926 | 1,025,821 |
Accrued expenses and accrued interest | -44,156 | -11,097 | 682,749 |
Accrued interest, related parties | 0 | 0 | -16,175 |
Deferred rent | -695 | -1,232 | 6,563 |
Net cash used in operating activities | -1,429,289 | -617,751 | -29,140,882 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' | ' |
Purchase of equipment | 0 | 0 | -97,392 |
Net cash used in investing activities | 0 | 0 | -97,392 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' | ' |
Proceeds from notes payable to related parties | 0 | 0 | 3,063,484 |
Proceeds from senior convertible notes, net | 0 | 0 | 14,650,088 |
Proceeds from senior convertible notes, related party, net | 0 | 0 | 686,250 |
Proceeds from Series C-1 preferred stock, net | 0 | 0 | 1,463,439 |
Proceeds from Series C-2 preferred stock, related party, net | 0 | 0 | 1,463,439 |
Proceeds from Series C-3 preferred stock, net | 743,884 | 0 | 743,884 |
Proceeds from Series C-3 preferred stock, related party | 575,000 | 0 | 575,000 |
Proceeds from exercise of warrants | 0 | 0 | 60,000 |
Proceeds from exercise of stock options | 213,650 | 0 | 216,050 |
Proceeds from Galenica, Ltd. promissory note | 0 | 0 | 1,000,000 |
Payments for deferred financing costs | -2,366 | -25,000 | -1,677,666 |
Repayment of amounts loaned under related party notes | 0 | 0 | -1,981,574 |
Proceeds from sale of equity securities | 6,723,248 | 533,000 | 18,213,518 |
Repurchase of outstanding warrants | 0 | -33,000 | -33,000 |
Proceeds from receipt of stock subscriptions and issuances of common stock | 0 | 0 | 4,827 |
Net cash provided by financing activities | 8,253,416 | 475,000 | 38,447,739 |
Foreign exchange effect on cash | -8,622 | ' | -20,067 |
NET INCREASE (DECREASE) IN CASH | 6,815,505 | -142,751 | 9,189,398 |
CASH - BEGINNING OF PERIOD | 2,373,893 | 835,471 | 0 |
CASH - END OF PERIOD | 9,189,398 | 692,720 | 9,189,398 |
Cash paid for interest | 465 | 26,938 | 136,954 |
Supplemental Disclosure of Non-Cash Financing Activities: | ' | ' | ' |
Conversion of notes payable and accrued interest to common stock, fair value | 0 | 0 | 20,665,889 |
Exchange of convertible notes to preferred stock | 0 | 0 | 1,119,340 |
Conversion of preferred stock to common stock | 2,447,384 | 0 | 3,049,489 |
Conversion of accounts payable and accrued expenses to preferred stock | 645,458 | 0 | 645,458 |
Reclassification of derivative liability to equity | 6,235,398 | 0 | 6,235,398 |
Reclassification of deferred financing fees to additional paid-in capital | 0 | 0 | 148,014 |
Stock issued to technology finders and licensors | 0 | 0 | 155 |
Warrants issued to placement agent | 0 | 0 | 854,608 |
Debt discount on senior convertible notes | 0 | 0 | 6,312,768 |
Dividend - beneficial conversion feature | 27,150 | 309,944 | 411,458 |
Accrued deferred financing cost | 0 | 0 | 33,169 |
Accrued private placement expenses | $0 | $25,867 | $25,867 |
1_Organization_Business_and_Ba
1. Organization, Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2014 | |
Organization Business And Basis Of Presentation | ' |
Organization, Business and Basis of Presentation | ' |
Organization and Business: | |
CorMedix Inc. (“CorMedix”, “we” or the “Company”) was incorporated in the State of Delaware on July 28, 2006. CorMedix is a development-stage company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiorenal and infectious diseases, including the dialysis and non-dialysis areas. The Company is in the process of transitioning from a development stage to a commercial pharmaceutical and medical device company. As of the date of this report, the Company has in-licensed all of the product candidates in its pipeline. The Company formed a wholly-owned subsidiary, CorMedix Europe GmbH, in 2013. | |
Basis of Presentation: | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions for Form 10-Q and Article 10 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2014 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 31, 2014. The accompanying condensed balance sheet as of December 31, 2013 has been derived from the audited financial statements included in such Form 10-K. | |
The Company’s primary activities since incorporation have been organizational activities, including recruiting personnel, acquiring licenses for its pharmaceutical product candidates, performing business and financial planning, performing research and development, establishing office facilities, seeking regulatory approval for its products, and raising funds through the issuance of debt and common stock. | |
To date, the Company has not generated significant revenues and, accordingly, the Company is considered to be in the development stage. For the three months ended March 31, 2014 and the period from July 28, 2006 (inception) to March 31, 2014, the Company incurred net losses of $16,713,291 and $72,079,622, respectively. The Company has a stockholders’ deficiency as of March 31, 2014 of $3,729,021. Management believes that the Company’s existing cash will be sufficient to meet the Company’s operating needs to fund its research and development, as well as its operations in general into 2015. 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 additional expenses as it continues to commercialize Neutrolin in Europe and other foreign markets and seeks FDA approval of Neutrolin® in the U.S. |
2_Summary_of_Significant_Accou
2. Summary of Significant Accounting Policies | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Summary of Significant Accounting Policies | ' | ||||||||
Use of Estimates: | |||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. | |||||||||
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: | |||||||||
Cash and cash equivalents include cash accounts and all investments purchased with initial maturities of three months or less. We attempt to mitigate our exposure to liquidity, credit and other relevant risks by placing our cash and cash equivalents with financial institutions we believe are structurally sound. 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 for the three months ended March 31, 2014 and the period from July 28, 2006 (inception) to March 31, 2014 of $12,203 and $14,204, respectively, all of which was attributable to its European operations, which are based in Germany. Of the Company’s $33,574 of net property and equipment at March 31, 2014, $1,954 was located in the United States, with the remainder located in Germany. | |||||||||
Restricted Cash: | |||||||||
The Company has 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 will terminate without penalties once the transaction covered by the letter of credit is completed. The certificate of deposit is recorded on the consolidated balance sheets 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. | |||||||||
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 Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 605, Revenue Recognition (“ASC 605”). | |||||||||
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 ordering dialysis center. The distributor then remits payment to the Company upon collection from the customer. In accordance with SAB 101 and SAB 104, the Company recognizes revenue from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable and collectability is reasonably assured. The Company recognizes net sales upon shipment of product to the dialysis centers. | |||||||||
Loss per common share: | |||||||||
Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share 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. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. | |||||||||
Three Months Ended | |||||||||
31-Mar-14 | 31-Mar-13 | ||||||||
Convertible notes | - | 3,782,857 | |||||||
Series A non-voting convertible preferred stock | - | 287,324 | |||||||
Series B non-voting convertible preferred stock | 454,546 | - | |||||||
Series C non-voting convertible preferred stock | 3,500,000 | - | |||||||
Series D non-voting convertible preferred stock | 1,148,000 | - | |||||||
Series E non-voting convertible preferred stock | 1,104,280 | - | |||||||
Shares underlying outstanding warrants | 11,571,233 | 8,610,665 | |||||||
Shares underlying outstanding stock options | 3,804,000 | 3,298,297 | |||||||
Total | 21,582,059 | 15,979,143 | |||||||
Stock-Based Compensation: | |||||||||
Stock-based compensation cost, net of expected forfeitures, granted to employees, officers and directors is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense over the 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 method. The non-cash charge to operations for non-employee options with service vesting is revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to consulting expense over the related vesting period. For stock options granted to non-employees with vesting contingent upon various performance metrics, the Company used the guidelines in accordance with FASB ASC No. 505-50, Equity-Based Payments to Non-Employees. For options having performance conditions that are outside of the control of the non-employee, the cost to be recognized is the lowest aggregate fair value prior to the achievement of the performance condition, even if the Company believes it is probable that the performance condition will be achieved. | |||||||||
During the three months ended March 31, 2014 and 2013, options to purchase an aggregate of 900,000 and 1,400,000 shares of common stock, respectively, were granted to the Company’s employees, officers, directors and consultants. | |||||||||
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 certain financial instruments that contain 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 modification of the warrant exercise price are accounted for as derivative liabilities. The changes in fair value of the warrant liabilities are re-measured at each balance sheet date and recorded as income or expense. | |||||||||
3_Stockholders_Equity
3. Stockholders' Equity | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
STOCKHOLDERS' DEFICIT | ' | ||||||||||||||||
Stockholders' Equity | ' | ||||||||||||||||
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. The warrants have 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. 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 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. | |||||||||||||||||
During the quarter ended March 31, 2014, stock options to purchase 275,000 shares of the Company’s common stock were exercised resulting in gross proceeds of $213,650 to the Company. | |||||||||||||||||
During the quarter ended March 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 quarter ended March 31, 2014, warrants to purchase 887,292 shares of the Company’s common stock were exercised on a cashless basis resulting in the issuance of 751,689 shares of the Company’s common stock. | |||||||||||||||||
Preferred Stock | |||||||||||||||||
In January 2014, the Company sold to various investors 200,000 shares of Series C-3 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 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 preferred stock has rights, privileges and terms that are identical to the Company’s Series C-1 and C-2 non-voting convertible preferred 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 at a conversion price of $1.00 per share. However, the holder is prohibited from converting Series C-3 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, have an exercise price of $1.25 per share, 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 is 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. | |||||||||||||||||
Due to the existence of downround provisions, the conversion features of the Series C-3 stock and the associated warrants are liability classified and are 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. | |||||||||||||||||
In January 2014, outstanding Series C-1 preferred stock of 140,000 shares was 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. | |||||||||||||||||
In February 2014, the downround protection of Series C-2 and Series C-3 preferred stock was eliminated pursuant to its terms resulting in the reclassification of the derivative liability to equity in the amount of $6,235,398. | |||||||||||||||||
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 key assumptions used in the Monte Carlo models are as follows: | |||||||||||||||||
Stock price – Due to the historical volatility of the 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 1) the historical volatility of the stock of CorMedix for approximately three-years, 2) the volatility used for prior period valuations 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. | |||||||||||||||||
Stock Options | |||||||||||||||||
During the three months ended March 31 2014, the Company granted to its officers and directors ten-year non-qualified stock options under the 2013 Plan, covering an aggregate of 900,000 shares of the Company’s common stock with an exercise price of $2.02 per share. Of these options, 750,000 vested on the date of grant and the remaining 150,000 options vest one year after the grant date. | |||||||||||||||||
During the three months ended March 31, 2014, total compensation expense for stock options issued to employees, directors, officers and consultants was $1,415,244. For the three months ended March 31, 2013 compensation expense was $70,764 offset by the reversal of $88,687 of previously recognized expense related to stock options forfeited and for the period from July 28, 2006 (inception) to March 31, 2014, compensation expense recorded was $5,359,618. | |||||||||||||||||
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: | |||||||||||||||||
Three Months Ended | Three Months Ended | ||||||||||||||||
31-Mar-14 | 31-Mar-13 | ||||||||||||||||
Expected Term | 5 – 9.75 years | 5 years | |||||||||||||||
Volatility | 96% - 113% | 118% - 131% | |||||||||||||||
Dividend yield | 0.00% | 0.00% | |||||||||||||||
Risk-free interest rate | 1.51% - 2.88% | 0.81% - 1.96% | |||||||||||||||
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 contractual terms established within agreements with the Company. Given the Company’s short period of publicly-traded stock history, management’s estimate of expected volatility is based on the average expected 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 Company has experienced forfeitures of stock options issued to its former officers, board member and employees. Consistent with its historical forfeiture experience, the Company has applied a forfeiture rate of approximately 32% and 39% to calculate stock option expense for the three month periods ended March 31, 2014 and 2013, respectively. The Company will continue to evaluate the estimated forfeiture rate derived from previous forfeitures of officers, directors and employees and may adjust the forfeiture rate based upon actual forfeitures that may occur in the future. | |||||||||||||||||
A summary of the Company’s stock options activity and related information is as follows: | |||||||||||||||||
Three Months Ended | Three Months Ended | ||||||||||||||||
31-Mar-14 | 31-Mar-13 | ||||||||||||||||
Shares | Weighted | Shares | Weighted | ||||||||||||||
Average | Average | ||||||||||||||||
Exercise | Exercise | ||||||||||||||||
Price | Price | ||||||||||||||||
Outstanding at beginning of period | 3,453,630 | $ | 1.06 | 2,135,630 | $ | 1.26 | |||||||||||
Exercised | (275,000 | ) | $ | 0.78 | - | - | |||||||||||
Forfeited | - | - | (237,333 | ) | $ | 1.61 | |||||||||||
Expired | (274,630 | ) | $ | 3.16 | - | - | |||||||||||
Granted | 900,000 | $ | 2.05 | 1,400,000 | $ | 0.9 | |||||||||||
Outstanding at end of period | 3,804,000 | $ | 1.16 | 3,298,297 | $ | 1.08 | |||||||||||
Options exercisable | 2,765,000 | $ | 1.19 | 878,297 | $ | 1.91 | |||||||||||
Expected to vest | 706,520 | $ | 1.08 | 1,476,200 | $ | 0.78 | |||||||||||
Weighted-average fair value of options granted during the period | $ | 1.49 | $ | 0.77 | |||||||||||||
The weighted average remaining contractual life of stock options outstanding and expected to vest at March 31, 2014 is 8.56 years. The weighted average remaining contractual life of stock options exercisable at March 31, 2014 is 8.31 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 March 31, 2014 for those options that have an exercise price below the quoted closing price. As of March 31, 2014, the aggregate intrinsic value of stock options exercised and outstanding is $415,350 and $5,127,540, respectively. | |||||||||||||||||
As of March 31, 2014, the total compensation expense related to non-vested options not yet recognized totaled $651,299. The weighted-average vesting period over which the total compensation expense related to non-vested options not yet recognized at March 31, 2014 was approximately 0.73 years. | |||||||||||||||||
Warrants | |||||||||||||||||
The following table is the summary of warrants outstanding at March 31, 2014: | |||||||||||||||||
Number of Warrants | Exercise Price | Expiration Date | |||||||||||||||
Issued to co-placement agents in connection with | 18,250 | 7.84 | |||||||||||||||
previous convertible note financings | 10/29/14 | ||||||||||||||||
Issued in connection with 2009 private placement | 503,034 | 3.4375 | 10/29/14 | ||||||||||||||
Issued in connection with IPO | 4,043,569 | 3.4375 | 3/24/15 | ||||||||||||||
Issued to IPO underwriters that, if exercised, would result | 4,812 | 3.90 | |||||||||||||||
in the issuance of an additional 4,812 shares of | |||||||||||||||||
common stock and warrants to purchase an additional | |||||||||||||||||
2,406 shares of common stock | 3/24/15 | ||||||||||||||||
Issued in connection with September 20, 2012 sale of | 1,687,500 | 0.4 | |||||||||||||||
convertible notes | 9/20/17 | ||||||||||||||||
Issued to placement agent in connection with September | 795 | 0.4 | |||||||||||||||
20, 2012 sale of convertible notes | 9/20/17 | ||||||||||||||||
Issued in connection with November 13, 2012 sale of | 25,000 | 0.4 | |||||||||||||||
convertible notes | 11/13/17 | ||||||||||||||||
Issued in connection with February 2013 sale of Series A | 400,000 | 1.5 | |||||||||||||||
convertible preferred stock | 2/19/18 | ||||||||||||||||
Issued in connection with license agreement amendment | 125,000 | 1.5 | 4/11/18 | ||||||||||||||
Issued in connection with July 2013 sale of Series B | 227,273 | 1.5 | |||||||||||||||
convertible preferred stock | 7/30/18 | ||||||||||||||||
Issued in connection with May 2013 sale of convertible | 1,000,000 | 1 | |||||||||||||||
notes, which funded in July 2013 | 5/30/19 | ||||||||||||||||
Issued in connection with October 2013 sale of Series C-1 | 1,500,000 | 1.25 | |||||||||||||||
and Series C-2 convertible preferred stock | 10/22/19 | ||||||||||||||||
Issued in connection with January 2014 sale of Series C-3 | 1,000,000 | 1.25 | |||||||||||||||
convertible preferred stock | 1/8/20 | ||||||||||||||||
Issued in connection with March 2014 sale of common | 1,036,000 | 3.1 | |||||||||||||||
stock | 9/10/19 | ||||||||||||||||
Total warrants outstanding at March 31, 2014 | 11,571,233 | ||||||||||||||||
4_Fair_Value_Measurements
4. Fair Value Measurements | 3 Months Ended | ||||||||||||
Mar. 31, 2014 | |||||||||||||
Fair Value Measurements | ' | ||||||||||||
Fair Value Measurements | ' | ||||||||||||
The fair value of the Company’s cash and accounts payable at March 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, carrying amounts and fair values of the Company’s derivative liabilities measured at fair value on a recurring basis as of March 31, 2014. There were no derivative liabilities measured at fair value on a recurring basis at March 31, 2013. | |||||||||||||
Fair Value Hierarchy Level | |||||||||||||
Increase in | |||||||||||||
Fair Value | Fair Value | ||||||||||||
Series C non-voting preferred stock | 3 | $ | - | $ | 5,257,295 | ||||||||
conversion option | |||||||||||||
Series D non-voting preferred stock | 3 | 2,715,484 | 1,813,858 | ||||||||||
conversion option | |||||||||||||
Series E non-voting preferred stock | 3 | 2,346,083 | 1,610,465 | ||||||||||
conversion option | |||||||||||||
Warrants issued in connection with | 3 | 2,121,842 | 1,460,973 | ||||||||||
convertible debt | |||||||||||||
Warrants issued in connection with | 3 | 5,177,914 | 3,538,978 | ||||||||||
Series C non-voting preferred stock | |||||||||||||
Total | $ | 12,361,323 | $ | 13,681,569 | |||||||||
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. | |||||||||||||
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 and warrants for the period ended March 31, 2014. | |||||||||||||
Balance at beginning of year | $ | 5,308,804 | |||||||||||
Additions to derivative liabilities | 2,053,732 | ||||||||||||
Conversion of convertible preferred stock to common stock | (2,447,384 | ) | |||||||||||
Reclassification from derivative liabilities to equity | (6,235,398 | ) | |||||||||||
Change in fair value of derivative liabilities | 13,681,569 | ||||||||||||
Balance at end of period | $ | 12,361,323 | |||||||||||
5_Commitments_and_Contingencie
5. Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Commitments and Contingencies | ' |
In February 2007, Geistlich Söhne AG für Chemische Industrie, Switzerland, or Geistlich, filed an opposition against the 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 opposition against the Sodemann patent that was filed at the head office of the European Patent Office in Munich, Germany, 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 described in the Lehner patent. In June 2008 the opposition division at the European Patent Office held oral proceedings and rejected the opposition by Geistlich and maintained the patent as granted. 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. 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 Sodemann patent covering Neutrolin, but remanded the proceeding to the opposition division as the lower court to consider restricting certain 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. 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. | |
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 will supply taurolidine (the API for Neutrolin) 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 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. The Navinta Agreement has a term of five years, but may be terminated by either party upon 30 days written notice. | |
6_Related_Party_Transactions
6. Related Party Transactions | 3 Months Ended | |||||||||||||
Mar. 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. Each share of Series C-3 preferred stock is convertible into 10 shares of common stock at a conversion price of $1.00 per share. All terms are the same as other investors in the private placement (see Note 3 – Stockholders’ Equity): | ||||||||||||||
Number of Series C-3 Preferred Stock | ||||||||||||||
Amount | Number of Warrants | |||||||||||||
Gary A. Gelbfish | Chairman of the Board | $ | 500,000 | 50,000 | 250,000 | |||||||||
Randy Milby | CEO and Director | $ | 237,000 | 23,700 | 118,500 | |||||||||
MW Bridges LLC, an entity for which Randy Milby is Managing Partner | $ | 23,000 | 1,300 | 6,500 | ||||||||||
Steven W. Lefkowitz | Interim CFO and Director | $ | 45,000 | 4,500 | 22,500 | |||||||||
Wade Capital Corporation Money Purchase Plan, an entity for which Steven W. Lefkowitz has voting and investment control | $ | 30,000 | 3,000 | 15,000 | ||||||||||
2_Summary_of_Significant_Accou1
2. Summary of Significant Accounting Policies (Policies) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Use of Estimates | ' | ||||||||
Use of Estimates: | |||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates. | |||||||||
Basis of Consolidation | ' | ||||||||
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 | ' | ||||||||
Cash and Cash Equivalents: | |||||||||
Cash and cash equivalents include cash accounts and all investments purchased with initial maturities of three months or less. We attempt to mitigate our exposure to liquidity, credit and other relevant risks by placing our cash and cash equivalents with financial institutions we believe are structurally sound. 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 | ' | ||||||||
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 | ' | ||||||||
Geographic Information: | |||||||||
The Company reported revenues for the three months ended March 31, 2014 and the period from July 28, 2006 (inception) to March 31, 2014 of $12,203 and $14,204, respectively, all of which was attributable to its European operations, which are based in Germany. Of the Company’s $33,574 of net property and equipment at March 31, 2014, $1,954 was located in the United States, with the remainder located in Germany. | |||||||||
Restricted Cash | ' | ||||||||
Restricted Cash: | |||||||||
The Company has 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 will terminate without penalties once the transaction covered by the letter of credit is completed. The certificate of deposit is recorded on the consolidated balance sheets as restricted cash. | |||||||||
Prepaid Expenses | ' | ||||||||
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: | |||||||||
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. | |||||||||
Revenue Recognition | ' | ||||||||
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 Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 605, Revenue Recognition (“ASC 605”). | |||||||||
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 ordering dialysis center. The distributor then remits payment to the Company upon collection from the customer. In accordance with SAB 101 and SAB 104, the Company recognizes revenue from product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred, the selling price is fixed or determinable and collectability is reasonably assured. The Company recognizes net sales upon shipment of product to the dialysis centers. | |||||||||
Loss per common share | ' | ||||||||
Loss per common share: | |||||||||
Basic loss per common share excludes any potential dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share 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. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive. | |||||||||
Three Months Ended | |||||||||
31-Mar-14 | 31-Mar-13 | ||||||||
Convertible notes | - | 3,782,857 | |||||||
Series A non-voting convertible preferred stock | - | 287,324 | |||||||
Series B non-voting convertible preferred stock | 454,546 | - | |||||||
Series C non-voting convertible preferred stock | 3,500,000 | - | |||||||
Series D non-voting convertible preferred stock | 1,148,000 | - | |||||||
Series E non-voting convertible preferred stock | 1,104,280 | - | |||||||
Shares underlying outstanding warrants | 11,571,233 | 8,610,665 | |||||||
Shares underlying outstanding stock options | 3,804,000 | 3,298,297 | |||||||
Total | 21,582,059 | 15,979,143 | |||||||
Stock-Based Compensation | ' | ||||||||
Stock-Based Compensation: | |||||||||
Stock-based compensation cost, net of expected forfeitures, granted to employees, officers and directors is measured at the grant date, based on the estimated fair value of the award, and is recognized as expense over the 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 method. The non-cash charge to operations for non-employee options with service vesting is revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to consulting expense over the related vesting period. For stock options granted to non-employees with vesting contingent upon various performance metrics, the Company used the guidelines in accordance with FASB ASC No. 505-50, Equity-Based Payments to Non-Employees. For options having performance conditions that are outside of the control of the non-employee, the cost to be recognized is the lowest aggregate fair value prior to the achievement of the performance condition, even if the Company believes it is probable that the performance condition will be achieved. | |||||||||
During the three months ended March 31, 2014 and 2013, options to purchase an aggregate of 900,000 and 1,400,000 shares of common stock, respectively, were granted to the Company’s employees, officers, directors and consultants. | |||||||||
Embedded Derivative Liabilities and Warrant Liabilities | ' | ||||||||
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 certain financial instruments that contain 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 modification of the warrant exercise price are accounted for as derivative liabilities. The changes in fair value of the warrant liabilities are re-measured at each balance sheet date and recorded as income or expense. |
2_Summary_of_Significant_Accou2
2. Summary of Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accounting Policies [Abstract] | ' | ||||||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share | ' | ||||||||
Three Months Ended | |||||||||
31-Mar-14 | 31-Mar-13 | ||||||||
Convertible notes | - | 3,782,857 | |||||||
Series A non-voting convertible preferred stock | - | 287,324 | |||||||
Series B non-voting convertible preferred stock | 454,546 | - | |||||||
Series C non-voting convertible preferred stock | 3,500,000 | - | |||||||
Series D non-voting convertible preferred stock | 1,148,000 | - | |||||||
Series E non-voting convertible preferred stock | 1,104,280 | - | |||||||
Shares underlying outstanding warrants | 11,571,233 | 8,610,665 | |||||||
Shares underlying outstanding stock options | 3,804,000 | 3,298,297 | |||||||
Total | 21,582,059 | 15,979,143 |
3_Stockholders_Equity_Tables
3. Stockholders' Equity (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
STOCKHOLDERS' DEFICIT | ' | ||||||||||||||||
Assumptions Used in Black-Scholes Option-Pricing Model | ' | ||||||||||||||||
Three Months Ended | Three Months Ended | ||||||||||||||||
31-Mar-14 | 31-Mar-13 | ||||||||||||||||
Expected Term | 5 – 9.75 years | 5 years | |||||||||||||||
Volatility | 96% - 113% | 118% - 131% | |||||||||||||||
Dividend yield | 0.00% | 0.00% | |||||||||||||||
Risk-free interest rate | 1.51% - 2.88% | 0.81% - 1.96% | |||||||||||||||
Summary of Option Activity under Plan and Related Information | ' | ||||||||||||||||
Three Months Ended | Three Months Ended | ||||||||||||||||
31-Mar-14 | 31-Mar-13 | ||||||||||||||||
Shares | Weighted | Shares | Weighted | ||||||||||||||
Average | Average | ||||||||||||||||
Exercise | Exercise | ||||||||||||||||
Price | Price | ||||||||||||||||
Outstanding at beginning of period | 3,453,630 | $ | 1.06 | 2,135,630 | $ | 1.26 | |||||||||||
Exercised | (275,000 | ) | $ | 0.78 | - | - | |||||||||||
Forfeited | - | - | (237,333 | ) | $ | 1.61 | |||||||||||
Expired | (274,630 | ) | $ | 3.16 | - | - | |||||||||||
Granted | 900,000 | $ | 2.05 | 1,400,000 | $ | 0.9 | |||||||||||
Outstanding at end of period | 3,804,000 | $ | 1.16 | 3,298,297 | $ | 1.08 | |||||||||||
Options exercisable | 2,765,000 | $ | 1.19 | 878,297 | $ | 1.91 | |||||||||||
Expected to vest | 706,520 | $ | 1.08 | 1,476,200 | $ | 0.78 | |||||||||||
Weighted-average fair value of options granted during the period | $ | 1.49 | $ | 0.77 | |||||||||||||
Summary of warrants outstanding | ' | ||||||||||||||||
Number of Warrants | Exercise Price | Expiration Date | |||||||||||||||
Issued to co-placement agents in connection with | 18,250 | 7.84 | |||||||||||||||
previous convertible note financings | 10/29/14 | ||||||||||||||||
Issued in connection with 2009 private placement | 503,034 | 3.4375 | 10/29/14 | ||||||||||||||
Issued in connection with IPO | 4,043,569 | 3.4375 | 3/24/15 | ||||||||||||||
Issued to IPO underwriters that, if exercised, would result | 4,812 | 3.90 | |||||||||||||||
in the issuance of an additional 4,812 shares of | |||||||||||||||||
common stock and warrants to purchase an additional | |||||||||||||||||
2,406 shares of common stock | 3/24/15 | ||||||||||||||||
Issued in connection with September 20, 2012 sale of | 1,687,500 | 0.4 | |||||||||||||||
convertible notes | 9/20/17 | ||||||||||||||||
Issued to placement agent in connection with September | 795 | 0.4 | |||||||||||||||
20, 2012 sale of convertible notes | 9/20/17 | ||||||||||||||||
Issued in connection with November 13, 2012 sale of | 25,000 | 0.4 | |||||||||||||||
convertible notes | 11/13/17 | ||||||||||||||||
Issued in connection with February 2013 sale of Series A | 400,000 | 1.5 | |||||||||||||||
convertible preferred stock | 2/19/18 | ||||||||||||||||
Issued in connection with license agreement amendment | 125,000 | 1.5 | 4/11/18 | ||||||||||||||
Issued in connection with July 2013 sale of Series B | 227,273 | 1.5 | |||||||||||||||
convertible preferred stock | 7/30/18 | ||||||||||||||||
Issued in connection with May 2013 sale of convertible | 1,000,000 | 1 | |||||||||||||||
notes, which funded in July 2013 | 5/30/19 | ||||||||||||||||
Issued in connection with October 2013 sale of Series C-1 | 1,500,000 | 1.25 | |||||||||||||||
and Series C-2 convertible preferred stock | 10/22/19 | ||||||||||||||||
Issued in connection with January 2014 sale of Series C-3 | 1,000,000 | 1.25 | |||||||||||||||
convertible preferred stock | 1/8/20 | ||||||||||||||||
Issued in connection with March 2014 sale of common | 1,036,000 | 3.1 | |||||||||||||||
stock | 9/10/19 | ||||||||||||||||
Total warrants outstanding at March 31, 2014 | 11,571,233 |
4_Fair_Value_Measurements_Tabl
4. Fair Value Measurements (Tables) | 3 Months Ended | ||||||||||||
Mar. 31, 2014 | |||||||||||||
Fair Value Measurements Tables | ' | ||||||||||||
Fair Value Measurements | ' | ||||||||||||
Fair Value Hierarchy Level | |||||||||||||
Increase in | |||||||||||||
Fair Value | Fair Value | ||||||||||||
Series C non-voting preferred stock | 3 | $ | - | $ | 5,257,295 | ||||||||
conversion option | |||||||||||||
Series D non-voting preferred stock | 3 | 2,715,484 | 1,813,858 | ||||||||||
conversion option | |||||||||||||
Series E non-voting preferred stock | 3 | 2,346,083 | 1,610,465 | ||||||||||
conversion option | |||||||||||||
Warrants issued in connection with | 3 | 2,121,842 | 1,460,973 | ||||||||||
convertible debt | |||||||||||||
Warrants issued in connection with | 3 | 5,177,914 | 3,538,978 | ||||||||||
Series C non-voting preferred stock | |||||||||||||
Total | $ | 12,361,323 | $ | 13,681,569 | |||||||||
Level 3 derivative liabilities | ' | ||||||||||||
Balance at beginning of year | $ | 5,308,804 | |||||||||||
Additions to derivative liabilities | 2,053,732 | ||||||||||||
Conversion of convertible preferred stock to common stock | (2,447,384 | ) | |||||||||||
Reclassification from derivative liabilities to equity | (6,235,398 | ) | |||||||||||
Change in fair value of derivative liabilities | 13,681,569 | ||||||||||||
Balance at end of period | $ | 12,361,323 |
6_Related_Party_Transactions_T
6. Related Party Transactions (Tables) | 3 Months Ended | |||||||||||||
Mar. 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. Each share of Series C-3 preferred stock is convertible into 10 shares of common stock at a conversion price of $1.00 per share. All terms are the same as other investors in the private placement (see Note 3 – Stockholders’ Equity): | ||||||||||||||
Number of Series C-3 Preferred Stock | ||||||||||||||
Amount | Number of Warrants | |||||||||||||
Gary A. Gelbfish | Chairman of the Board | $ | 500,000 | 50,000 | 250,000 | |||||||||
Randy Milby | CEO and Director | $ | 237,000 | 23,700 | 118,500 | |||||||||
MW Bridges LLC, an entity for which Randy Milby is Managing Partner | $ | 23,000 | 1,300 | 6,500 | ||||||||||
Steven W. Lefkowitz | Interim CFO and Director | $ | 45,000 | 4,500 | 22,500 | |||||||||
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_Organization_Business_and_Ba1
1. Organization, Business and Basis of Presentation (Details Narrative) (USD $) | 3 Months Ended | 92 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | |
Organization Business And Basis Of Presentation Details Narrative | ' | ' | ' |
Net loss | ($16,713,291) | ($1,247,051) | ($72,079,622) |
2_Summary_of_Significant_Accou3
2. Summary of Significant Accounting Policies (Details) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Antidilutive Shares | 21,582,059 | 15,979,143 |
Convertible notes | ' | ' |
Antidilutive Shares | 0 | 3,782,857 |
Series A non-voting convertible preferred stock | ' | ' |
Antidilutive Shares | 0 | 287,324 |
Series B non-voting preferred stock | ' | ' |
Antidilutive Shares | 454,546 | 0 |
Series C non-voting convertible preferred stock | ' | ' |
Antidilutive Shares | 3,500,000 | 0 |
Series D non-voting convertible preferred stock | ' | ' |
Antidilutive Shares | 1,148,000 | 0 |
Series E non-voting convertible preferred stock | ' | ' |
Antidilutive Shares | 1,104,280 | 0 |
Shares underlying outstanding warrants | ' | ' |
Antidilutive Shares | 11,571,233 | 8,610,665 |
Shares underlying outstanding stock options | ' | ' |
Antidilutive Shares | 3,804,000 | 3,298,297 |
3_Stockholders_Equity_Details
3. Stockholders' Equity (Details) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Stockholders Equity Details | ' | ' |
Expected Term | '5 years | '5 years |
Expected Term | '9.75 years | ' |
Volatility, minimum | 96.00% | 118.00% |
Volatility, maximum | 113.00% | 131.00% |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rate, minimum | 1.51% | 0.81% |
Risk-free interest rate, maximum | 2.88% | 1.96% |
3_Stockholders_Equity_Details_
3. Stockholders' Equity (Details 1) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Number of Options | ' | ' |
Number of Options Outstanding | 3,453,630 | 2,135,630 |
Number of Options Exercised | -275,000 | 0 |
Number of Options Forfeited | 0 | -237,333 |
Expired/Canceled | -274,630 | 0 |
Number of Options Granted | 900,000 | 1,400,000 |
Number of Options Outstanding | 3,804,000 | 3,298,297 |
Exercisable | 2,765,000 | 878,297 |
Expected to vest | 706,520 | 1,476,200 |
Weighted Average Exercise Price | ' | ' |
Weighted Average Exercise Price Outstanding, Beginning | $1.06 | $1.26 |
Weighted Average Exercise Price Exercised | $0.78 | ' |
Weighted Average Exercise Price Forfeited | ' | $1.61 |
Weighted Average Exercise Price Expired/Canceled | $3.16 | ' |
Weighted Average Exercise Price Granted | $2.05 | $0.90 |
Weighted Average Exercise Price Outstanding, Ending | $1.16 | $1.08 |
Weighted Average Exercise Price Exercisable | $1.19 | $1.91 |
Weighted Average Exercise Price expected to vest | $1.08 | $0.78 |
Aggregate Intrinsic Value | ' | ' |
Weighted-average fair value of options granted during the period | $1.49 | $0.77 |
3_Stockholders_Equity_Details_1
3. Stockholders' Equity (Details 2) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2013 | Dec. 31, 2012 |
Class of warrant or right, exercise price of warrants or rights | $1.16 | $1.06 | $1.08 | $1.26 |
Issued to co-placement agents in connection with previous convertible note financings | ' | ' | ' | ' |
Class of warrant or right, outstanding | 18,250 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $7.84 | ' | ' | ' |
Class of warrant or right, Expiration date | 29-Oct-14 | ' | ' | ' |
Issued in connection with 2009 private placement | ' | ' | ' | ' |
Class of warrant or right, outstanding | 503,034 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $3.44 | ' | ' | ' |
Class of warrant or right, Expiration date | 29-Oct-14 | ' | ' | ' |
Issued in connection with IPO | ' | ' | ' | ' |
Class of warrant or right, outstanding | 4,043,569 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $3.44 | ' | ' | ' |
Class of warrant or right, Expiration date | 24-Mar-15 | ' | ' | ' |
Issued to IPO underwriters that, if exercised, would result in the issuance of an additional 4,812 shares of common stock and warrants to purchase an additional 2,406 shares of common stock | ' | ' | ' | ' |
Class of warrant or right, outstanding | 4,812 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $3.90 | ' | ' | ' |
Class of warrant or right, Expiration date | 24-Mar-15 | ' | ' | ' |
Issued in connection with September 20, 2012 private placement of convertible notes | ' | ' | ' | ' |
Class of warrant or right, outstanding | 1,687,500 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $0.40 | ' | ' | ' |
Class of warrant or right, Expiration date | 20-Sep-17 | ' | ' | ' |
Issued to placement agent in connection with September 20, 2012 private placement of convertible notes | ' | ' | ' | ' |
Class of warrant or right, outstanding | 795 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $0.40 | ' | ' | ' |
Class of warrant or right, Expiration date | 20-Sep-17 | ' | ' | ' |
Issued in connection with November 13, 2012 sale of convertible notes | ' | ' | ' | ' |
Class of warrant or right, outstanding | 25,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $0.40 | ' | ' | ' |
Class of warrant or right, Expiration date | 13-Nov-17 | ' | ' | ' |
Issued in connection with February 2013 sale of Series A convertible preferred stock | ' | ' | ' | ' |
Class of warrant or right, outstanding | 400,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $1.50 | ' | ' | ' |
Class of warrant or right, Expiration date | 19-Feb-18 | ' | ' | ' |
Issued in connection with license agreement amendment | ' | ' | ' | ' |
Class of warrant or right, outstanding | 125,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $1.50 | ' | ' | ' |
Class of warrant or right, Expiration date | 11-Apr-18 | ' | ' | ' |
Issued in connection with July 2013 sale of Series B convertible preferred stock | ' | ' | ' | ' |
Class of warrant or right, outstanding | 227,273 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $1.50 | ' | ' | ' |
Class of warrant or right, Expiration date | 30-Jul-18 | ' | ' | ' |
Issued in connection with May 2013 sale of convertible notes, which funded in July 2013 | ' | ' | ' | ' |
Class of warrant or right, outstanding | 1,000,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $1 | ' | ' | ' |
Class of warrant or right, Expiration date | 30-May-19 | ' | ' | ' |
Issued in connection with October 2013 sale of Series C-1 and Series C-2 convertible preferred stock | ' | ' | ' | ' |
Class of warrant or right, outstanding | 1,500,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $1.25 | ' | ' | ' |
Class of warrant or right, Expiration date | 22-Oct-19 | ' | ' | ' |
Issued in connection with January 2014 sale of Series C-3 convertible preferred stock | ' | ' | ' | ' |
Class of warrant or right, outstanding | 1,000,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $1.25 | ' | ' | ' |
Class of warrant or right, Expiration date | 8-Jan-20 | ' | ' | ' |
Issued in connection with March 2014 sale of common stock | ' | ' | ' | ' |
Class of warrant or right, outstanding | 1,036,000 | ' | ' | ' |
Class of warrant or right, exercise price of warrants or rights | $3.10 | ' | ' | ' |
Class of warrant or right, Expiration date | 10-Sep-19 | ' | ' | ' |
Warrant Total | ' | ' | ' | ' |
Class of warrant or right, outstanding | 11,571,233 | ' | ' | ' |
4_Fair_Value_Measurements_Deta
4. Fair Value Measurements (Details) (USD $) | 3 Months Ended | 92 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | |
Series C non-voting preferred stock | $0 | ' | $0 |
Series D non-voting preferred stock | 2,715,484 | ' | 2,715,484 |
Series E non-voting preferred stock | 2,346,083 | ' | 2,346,083 |
Warrants issued in connection with convertible debt | 2,121,842 | ' | 2,121,842 |
Warrants issued in connection with Series C non-voting preferred stock | 5,177,914 | ' | 5,177,914 |
Financial Liabilities Measured at Fair Value on a Recurring Basis | 12,361,323 | ' | 12,361,323 |
Increase in fair value Series C | 5,257,295 | ' | ' |
Increase in fair value Series D | 1,813,858 | ' | ' |
Increase in fair value Series E | 1,610,465 | ' | ' |
Increase in fair value Warrants issued in connection with convertible debt | 1,460,973 | ' | ' |
Increase in fair value Warrants issued in connection with Series C non-voting preferred stock | 3,538,978 | ' | ' |
Increase in fair value | -13,681,569 | 0 | -14,045,488 |
Level 3 | ' | ' | ' |
Series C non-voting preferred stock | 0 | ' | 0 |
Series D non-voting preferred stock | 2,715,484 | ' | 2,715,484 |
Series E non-voting preferred stock | 2,346,083 | ' | 2,346,083 |
Warrants issued in connection with convertible debt | 2,121,842 | ' | 2,121,842 |
Warrants issued in connection with Series C non-voting preferred stock | 5,177,914 | ' | 5,177,914 |
Financial Liabilities Measured at Fair Value on a Recurring Basis | $12,361,323 | ' | $12,361,323 |
6_Related_Party_Transactions_D
6. Related Party Transactions (Details) (USD $) | 3 Months Ended |
Mar. 31, 2014 | |
Gary A. Gelbfish | ' |
Related party transaction | $500,000 |
Related party details Number of Series C-3 Preferred Stock and Number of Warrants | 'Number of Series C-3 Preferred Stock 50,000 Number of Warrants 250,000 |
Randy Milby | ' |
Related party transaction | 237,000 |
Related party details Number of Series C-3 Preferred Stock and Number of Warrants | 'Number of Series C-3 Preferred Stock 23,700 Number of Warrants 118,500 |
MW Bridges LLC | ' |
Related party transaction | 23,000 |
Related party details Number of Series C-3 Preferred Stock and Number of Warrants | 'Number of Series C-3 Preferred Stock 1,300 Number of Warrants 6,500 |
Steven W. Lefkowitz | ' |
Related party transaction | 45,000 |
Related party details Number of Series C-3 Preferred Stock and Number of Warrants | 'Number of Series C-3 Preferred Stock 4,500 Number of Warrants 22,500 |
Wade Capital Corporation | ' |
Related party transaction | $30,000 |
Related party details Number of Series C-3 Preferred Stock and Number of Warrants | 'Number of Series C-3 Preferred Stock 3,000 Number of Warrants 15,000 |