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EXCEL - IDEA: XBRL DOCUMENT - Medite Cancer Diagnostics, Inc.Financial_Report.xls
EX-32.1 - EXHIBIT 32.1 - Medite Cancer Diagnostics, Inc.v394790_ex32-1.htm
EX-31.2 - EXHIBIT 31.2 - Medite Cancer Diagnostics, Inc.v394790_ex31-2.htm
EX-31.1 - EXHIBIT 31.1 - Medite Cancer Diagnostics, Inc.v394790_ex31-1.htm
EX-32.2 - EXHIBIT 32.2 - Medite Cancer Diagnostics, Inc.v394790_ex32-2.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

(Mark One)

 

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  For the quarterly period ended September, 30, 2014
   
   
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  For the transition period from                          to                          .   

 

Commission File number 0-935

 

CYTOCORE, INC.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware   36-4296006
(State or Other Jurisdiction of   (I.R.S. Employer
Incorporation or Organization)   Identification No.)

 

4203 SW 34th St.

Orlando, FL 32811

(Address of Principal Executive Offices)

 

(407) 996-9631

(Registrant’s Telephone Number, Including Area Code)

 

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).

Yes x No o (not required) o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rue 12b-2 of the Exchange Act. (Check one):

 

Large Accelerated Filer o           Accelerated Filer

 

Non-Accelerated Filer o           Smaller Reporting Company x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

 

The number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date:

 

common STOCK, $0.001 par value, AT November 19, 2014: 1,934,607,971 

 
 

 

CYTOCORE, Inc.

 

Quarterly Report on Form 10-Q

 

Table of contents

 

PART I.  – FINANCIAL INFORMATION Page
     
Item 1. Financial Statements  
     
a) Condensed Consolidated Balance Sheets – September 30, 2014 (unaudited) and December 31, 2013 3
     
b) Condensed Consolidated Statements of Operations -- Three and Nine months ended September 30, 2014 and September 30, 2013 (unaudited) 4
     
c) Condensed Consolidated Statements of Cash Flows -- Nine months ended September 30, 2014 and September 30, 2013  (unaudited) 6
     
d) Notes to Unaudited Condensed Consolidated Financial Statements 7
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 14
     
Item 4. Controls and Procedures 18
     
Part II. -- Other Information  
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 18
     
Item 3. Defaults upon Senior Securities 18
     
Item 6. Exhibits 19
     
SIGNATURES 20
     
EXHIBIT INDEX 21
     
Exhibit 31.1     Section 302 Certification of Chief Executive Officer  
Exhibit 31.2     Section 302 Certification of Chief Financial Officer  
Exhibit 32.1     Section 906 Certification of Chief Executive Officer  
Exhibit 32.1     Section 906 Certification of Chief Financial Officer  

 

2
 

 

Part I. -- Financial Information

 

CYTOCORE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Dollars in thousands, except per share amounts)

(Unaudited)

 

   September 30,   December 31 
   2014   2013 
       * 
Assets          
           
Current Assets:          
Cash  $215   $75 
Accounts receivable, net of allowance for doubtful accounts   1,414    1,594 
Inventories   4,946    3,953 
Prepaid expenses and other current assets   224    487 
Total current assets   6,799    6,109 
Property and equipment, net   2,097    1,867 
Goodwill   12,461    - 
Other Assets   484    194 
Total assets  $21,841   $8,170 
           
Liabilities and Stockholders’ Equity          
           
Current Liabilities:          
Secured lines of credit and current portion of long-term debt  $3,133   $2,739 
Account payable and accrued expenses   3,832    1,236 
    Advance – Related Parties   115    - 
Total current liabilities   7,080    3,975 
Long term debt, net of current portion   1,104    1,571 
         Total Liabilities   8,184    5,546 
           
Commitments and Contingencies          
           
Stockholders’ Equity :          
Preferred stock, $0.001 par value; 10,000,000 shares authorized; 373,355 shares issued and outstanding as of September 30, 2014 (liquidation value of all classes of preferred stock $2,871 as of September 30, 2014)   1,487    - 
Common stock, $0.001 par value; 2.0 billion shares authorized, 1,934,607,971 issued and issuable as of September 30, 2014   1,935    1,469 
Additional paid-in capital   7,847    (1,469)
Treasury Stock   (327)   - 
Accumulated other comprehensive income (loss)   328    287 
Retained Earnings   2,387    2,337 
Total stockholders’ equity   13,657    2,624 
           
Total liabilities and stockholders’ equity  $21,841   $8,170 

 *Derived from audited information

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3
 

  

CYTOCORE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

(Dollars in thousands, except per share amounts)

(Unaudited)

 

   Three months ended September 30, 
   2014   2013 
         
Net Sales  $2,785    2,622 
Operating Expenses          
Cost of revenues   1,198    1,026 
Depreciation expense   48    44 
Research and development   317    56 
Selling, general and administrative   1,260    1,119 
           
Total cost and expenses  $2,823    2,245 
Operating  Income (Loss)  $(38)   377 
           
Other Expenses          
Interest expense   71    59 
Non-operating expenses (income)   2    40 
           
Total other expenses  $73    99 
Income (loss )from operations before income taxes  $(111)   278 
           
Income taxes (benefit)   8    27 
Net Income (loss)  $(119)   251 
Preferred dividend   18    - 
Net Income (loss) to common stockholders   (137)   251 
           
Statement of Comprehensive Income          
Net Income (loss)   (119)   251 
Other Comprehensive income (loss)          
    Foreign currency translation adjustments   45   (2)
Comprehensive income (loss)   (74)   249 
           
Pro Forma Earnings Per Share          
Net income (loss) to common stockholders   (137)   251 
Pro forma basic and diluted earnings per share   -    - 
Pro forma weighted average basic and diluted shares outstanding   1,934,523,054    1,468,750,000 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4
 

 

CYTOCORE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

(Dollars in thousands, except per share amounts)

(Unaudited)

 

   Nine Months Ended September 30, 
   2014   2013 
         
Net Sales  $8,694    7,102 
Operating Expenses          
Cost of revenues   4,456    3,310 
Depreciation expense   126    136 
Research and development   762    525 
Selling, general and administrative   2,902    2,634 
           
Total cost and expenses  $8,246    6,605 
Operating  Income  $448    497 
           
Other Expenses          
Interest expense   221    189 
Non-operating expenses   153    63 
           
Total other expenses  $374    252 
Income from operations before income taxes  $74    245
           
Income taxes   24    35 
Net Income  $50    210
Preferred dividend   54    - 
Net Income (loss) to common stockholders   (4)   210
           
Statement of Comprehensive Income          
Net Income   50    210
Other Comprehensive income          
    Foreign currency translation adjustments   41   0 
Comprehensive income (loss)   91    210
           
Pro Forma Earnings Per Share          
Net income to common stockholders   (4)   210
Pro forma basic and diluted earnings per share   1,768,328,421    1,468,750,000 
Pro forma weighted average basic and diluted shares outstanding          

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

5
 

  

CYTOCORE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Dollars in thousands)

(Unaudited)

 

   Nine months Ended September 30, 
   2014   2013 
Cash Flows from Operating Activities:          
Net Income (loss)  $50   $210
Adjustments to reconcile net income (loss) to cash (used in) provided by operations          
Depreciation and amortization   126    136 
Non-cash Interest   4    - 
Changes in assets and liabilities:          
Accounts receivable and allowance for doubtful accounts   56    21 
Inventories   (1,058)   (586)
Prepaid expenses and other current assets   (150)   242
Accounts payable and accrued liabilities   (391)   (26)
Net cash (used in) provided by operating activities   (1,363)   (3)
           
Cash Flows from Investing activity:          
Purchase of Equipment   (391)   (279)
Cash Acquired in Merger   1    - 
Proceeds from Related Party Advances   9    - 
Net cash provided from (used in) investing activities   (381)   (279)
           
Cash Flows from Financing activities:          
    Advances net of repayments on lines of credit   180    670 
    Proceeds from Sale of Common Stock   1,842    - 
    Term note repayments   (159)   (260)
Net cash provided by (used by) financing activities   1,863    410 
           
Effect of exchange rates on cash and cash equivalents   21   (182)
Net increase  in cash and cash equivalents   140    (54)
Cash and cash equivalents at beginning of year   75    65 
           
Cash and cash equivalents at end of the period  $215   $11 
           
Cash paid for income taxes   16    8 
Cash paid for interest   149    130 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

6
 

  

1. Organization and Summary of Significant Accounting Policies

 

CytoCore, Inc. is a Delaware Corporation engaged in the business of cancer diagnosis and prevention, particularly within histology (processing of tissue samples) and cytology (processing of cellular material). The Company is active in the development, manufacture and marketing of a wide product range within the histology market.
 

These statements include the accounts of CytoCore, Inc. (the “Company”, “we” and “us”) and its wholly owned subsidiaries, which consists of Medite Enterprise, Inc., Medite GmbH, Burgdorf, Germany, Medite GmbH, Salzburg, Austria, Medite Lab Solutions Inc. (formerly Medite Inc.), Orlando, USA, and CytoGlobe, GmbH, Burgdorf, Germany

 

In April 2014, in a transaction more fully described in Footnote 2, the shareholders of the Company consummated a transaction in which 100% of the issued and outstanding shares of Medite Enterprise, Inc. were acquired by CytoCore, Inc. in exchange for the issuance by CytoCore, Inc. of 1,468,750,000 shares of its common stock to the shareholders of the Company. The result of this transaction was for the Company and its wholly owned subsidiaries to become wholly owned subsidiaries of CytoCore, Inc., a US public company. In addition, the shareholders of the Company became the majority owners of CytoCore, Inc., which resulted in the transaction being accounted for as a reverse merger, in which the financial statements of Medite Enterprise, Inc. and its subsidiaries became those of CytoCore, Inc.

 

The consolidated financial statements for the periods ended September 30, 2014 and 2013 included herein are unaudited. Such consolidated financial statements reflect, in the opinion of management, all adjustments necessary to present fairly the financial position and results of operations as of and for the periods indicated. All such adjustments are of a normal recurring nature. These interim results are not necessarily indicative of the results to be expected for the fiscal year ending December 31, 2014 or for any other period. Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission. The Company believes that the disclosures are adequate to make the interim information presented not misleading. These consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto included in in an 8-K/A filing dated June 17, 2014.

 

Consolidation, Basis of Presentation and Significant Estimates

 

The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions are eliminated. In preparing the accompanying financial statements, management has made certain estimates and assumptions that affect reported amounts in the financial statements and disclosures of contingencies. Significant assumptions are required in the valuation of the allowance for doubtful accounts and inventory overhead allocations. Significant assumptions also are required in the Company’s estimation of warranty reserves. Changes in facts and circumstances may result in revised estimates and actual results may differ from these estimates.

 

Revenue Recognition

 

The Company derives its revenue primarily from the sale of medical products and supplies for the diagnosis and prevention of cancer. Product revenue is recognized when all four of the following criteria are met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products has occurred; (3) the selling price of the product is fixed or determinable; and (4) collectability is reasonably assured. The Company generates the majority of its revenue from the sale of inventory. The Company recognizes revenue when title and risk of loss transfer to the customer and all other revenue recognition criteria have been met. For a small subset of sales in Germany, the Company and its customers agree in the sales contract that risk of loss and title transfer upon the Company packing the items for shipment and notifying the Customer that their items are ready for pickup. The Company records such sales at time of completed packaging and segregation of the items from general inventory and notification has been confirmed by the customer.

 

7
 

  

Cash and Cash Equivalents

 

The Company considers all cash on deposit and highly-liquid debt instruments purchased with original maturities of three months or less to be cash and cash equivalents.

 

Accounts Receivable

 

The Company generates accounts receivable from the sale of its products. The Company provides for a reserve against receivables for estimated losses that may result from a customer's inability or unwillingness to pay. The allowance for doubtful accounts is estimated primarily based upon historical write-off percentages, known problem accounts, and current economic conditions. Accounts are written off against the allowance for doubtful accounts when the Company determines that amounts are not collectable. Recoveries of previously written-off accounts are recorded when collected.

 

Inventories

 

Inventories are stated at the lower of cost or market. Market, which represents selling price less cost to sell, considers general market and economic conditions, periodic reviews of current profitability and product warranty costs. Work in process and supplies of consumables are reviewed to determine if inventory quantities are in excess of forecasted usage or if they have become obsolete.

 

Property and Equipment

 

Property and equipment are stated at cost, less accumulated depreciation and amortization. Property and equipment are depreciated using the straight-line method over the estimated useful lives of the assets as follows:

 

Buildings 33 yrs
Machinery and equipment 3-10yrs
Office furniture and equipment 2-10 yrs
Vehicles 5 yrs
Computer equipment 3-5 yrs

 

Normal maintenance and repairs for equipment are charged to expense as incurred, while significant improvements are capitalized.

 

Research and Development

 

All research and development costs are expensed as incurred. Research and development costs consist of engineering, product development, testing, developing and validating the manufacturing process, and regulatory related costs.

 

Pro Forma Financial Information

 

As discussed in Note 1, in April 2014, the Company was acquired by CytoCore, Inc., a US public company. Upon closing of the Merger, the financial statements Medite Enterprise, Inc. became those of CytoCore, Inc. Pursuant to Securities and Exchange Commission Staff Accounting Bulletin Number 1B.2 "Pro Forma Financial Statements and Earnings per Share" ("SAB 1B.2"), pro forma earnings per share information on the face of the statement of operations has been presented which reflects the impact of the Company's change in capital structure as if it had occurred at the commencement of operations on January 1, 2013.

 

8
 

 

2. Reverse Merger

 

In January 2014, the Company and the owners of Medite Enterprise, Inc. entered into an agreement to merge with CytoCore, Inc.. The merger required as a pre-requisite that among other items CytoCore settle certain outstanding payroll amounts in stock and that CytoCore complete a private placement with gross proceeds of a minimum of $2 million, which was later amended to $1.5 million. On April 3, 2014 CytoCore issued 69,723,439 shares of its common stock in satisfaction of approximately $1.61 million in outstanding accrued payroll and on April 4, 2014 also closed on a private placement in which it received gross proceeds of $1.529 million and issued 95,587,500 shares of its common stock. The merger closed on April 4, 2014 with the owners of Medite Enterprise, Inc. receiving 1,468,750,000 shares of the Company’s common stock plus an additional 31,250,000 shares issuable if certain conditions are met, in exchange for 100% of the issued and outstanding stock of Medite Enterprise, Inc.

 

Because the owners of Medite Enterprise, Inc. received approximately 81.1% of the then issued and outstanding stock of the Company, the merger has been treated as a reverse acquisition, in which for accounting purposes Medite Enterprise, Inc. acquired CytoCore, Inc. The table below shows the management’s best estimate of the purchase price paid for the reverse acquisition of CytoCore by Medite Enterprise, Inc. :

 

   In thousands 
Net assets acquired    
Cash  $1 
Accounts receivable   8 
Goodwill   12,461 
   $12,470 
      
Liabilities assumed     
Accounts payable & accrued expenses  $2,908 
Related party advances   102 
Loans payable   21 
   $3,031 
      
Net identifiable assets/consideration paid  $9,439 

 

The amounts included in the table above are management’s estimates. Because of the issues regarding the liquidity and trading of the stock of the Company, the Company has used an internal valuation for the consideration and assets acquired. The Company expects to obtain professional valuations prior to year end and that the amounts show above will be subject to change upon the Company obtaining those valuations. The most significant estimates subject to change above are the consideration paid, the amount of intangible assets for the possible value attributable to the technology and patents, in process research and development, net deferred tax assets (see discussion below), accounts payable and accrued expenses and finally goodwill.

 

The transaction entered into by CytoCore, Inc. to satisfy outstanding officer loans in 2013 and the merger consideration paid to the owners of Medite Enterprise, Inc. has resulted in a “change of control” as defined in Section 382 of the internal revenue code as of April 2014. The effect of this change in control is that the past net operating losses of CytoCore, Inc. which amounted to approximately $72 million will be limited as defined in Section 382 of the internal revenue code. The Company is required under Section 382 to perform a valuation that will determine the amount of net operating losses from each loss year that may be taken in each year on a go-forward basis. Because the Company has yet to perform or obtain this valuation, the amount and timing of the availability of its loss carryforwards from CytoCore, Inc. are unknown at this time. Upon determination of this amount, a significant deferred tax asset may be recorded which will affect the final net assets acquired above. The Company expects to obtain this valuation by the end of the first quarter of 2015.

 

9
 

  

3. Inventories

 

The following is a summary of the components of inventories (in thousands):

 

   September 30,   December 31, 
   2014   2013 
Raw materials  $2,144   $1,748 
Work in progress   151    137 
Finished Goods   2,651    2,068 
           
   $4,946   $3,953 

 

No amounts were reserved for scrap or obsolete inventory as of September 30, 2014 and December 31, 2013, respectively.

 

 4. Property and Equipment

 

The following is a summary of the components of property and equipment as of (in thousands):

 

   September 30,   December 31, 
   2014   2013 
Land  $244   $244 
Buildings   1,352    1,352 
Machinery and equipment   1,039    407 
Office furniture and equipment   262    240 
Vehicles   39    39 
Computer equipment   86    86 
Construction in progress   88    386 
Less: Accumulated depreciation   (1,013)   (887)
   $2,097   $1,867 

 

Depreciation expense amounted to approximately $126,204 and $136,000 for the nine months ended September 30, 2014 and 2013, respectively and is included in the cost of revenues line item on the statement of operations.

 

5. Debt and Line of Credit

 

Our outstanding note payable indebtedness was as follows as of (in thousands):

 

   September 30,   December 31, 
   2014   2013 
Hannoversech Volksbank Credit line #1  $471   $759 
Hannoversech Volksbank Credit line #2   1,587    1,333 
Hannoversech Volksbank Credit line #3   488    444 
Hannoversech Volksbank term loan #1   175    211 
Hannoversech Volksbank term loan #2   109    138 
Hannoversech Volksbank term loan #3   354    393 
Participation rights   1,032    1,032 
Ventana Medical Systems   21    - 
   $4,237   $4,310 

  

10
 

 

In July 2006, Medite GmbH, Burgdorf, entered into a line of credit agreement with Hannoversche Volksbank. The line of credit granted a maximum borrowing authority of 400,000 euros, which was amended in 2012 to increase the maximum borrowing to 600,000 euros with a variable interest rate of 8% per annum as of December 31, 2013. The line of credit has no stated maturity date but may be cancelled by the bank upon notice to the Company. The line of credit is collateralized by the accounts receivable and inventory of Medite GmbH, Burgdorf and is guaranteed by the shareholders of the Company.

 

In July 2006, Medite GmbH, Burgdorf, entered into a secondary line of credit agreement with Hannoversche Volksbank. The line of credit granted a maximum borrowing authority of 480,000 euros, which was later amended to increase the maximum borrowing to 1 million euros with a variable interest rate of approximately 3.98% as of December 31, 2013. The line of credit has no stated maturity date but may be cancelled by the bank upon notice to the Company. The line of credit is guaranteed by the shareholders of the Company and a mortgage on the property of the Company. In addition, the shareholders have named the bank as beneficiary on a term life insurance policy on each shareholder in the amount of 500,000 euros.

 

In June 2012, CytoGlobe, GmbH, Burgdorf, entered into a line of credit agreement with Hannoversche Volksbank. The line of credit granted a maximum borrowing authority of 400,000 euros. The credit line is split into two tranches for interest rate purposes, with the first 200,000 euro tranche at a variable rate of approximately 4% per annum at December 31, 2013 and the second 200,000 euro tranche at 8% per annum. The line of credit has no stated maturity date but may be cancelled by the bank upon notice to the Company. The line of credit is collateralized by the accounts receivable and inventory of CytoGlobe GmbH, Burgdorf and is guaranteed by the shareholders of the Company.

 

In December 2006, Medite GmbH, Burgdorf, entered into a 500,000 euro term loan agreement with Hannoversche Volksbank with an interest rate of 3.4% per annum. The term loan has a maturity of September 2016 and requires semi-annual principal payments of approximately 27,780 euros each. The term loan is guaranteed by the stockholders of the Company and also a mortgage on the property of the Company.

 

In June 2006, Medite GmbH, Burgdorf, entered into a 400,000 euro term loan with Hannoversche Volksbank with an interest rate of 3.6 per annum. The term loan has a maturity of June 2016, requires 18 semi-annual principal repayments of approximately 22,220 euro each. The term loan is guaranteed by the stockolders of the Company and also has subordinated assignments of all of the receivables and inventories of Medite GmbH, Burgdorf and also has a subordinated pledge of stockholder term life insurance policies.

 

In November 2008, Medite GmbH, Burgdorf, entered into a 400,000 euro term loan with Hannoversche Volksbank with a variable interest rate of approximately 4.7% per annum as of December 31, 2013. The term loan has a maturity of December 31, 2018, and requires quarterly principal repayments of 13,890 euro each. The term loan is guaranteed by the stockholders of the Company and also includes a partial subordinated pledge of the receivables and inventory of Medite GmbH, Burgdorf.

 

In March 2009, the Company entered into a participation rights agreement in the form of a debenture which a mezzanine lender agreed to advance the Company up to 1.5 million euros in two tranches of 750,000 euros each. The first tranche was paid to the Company at closing with the second tranche being conditioned on Medite GmbH, Burgdorf and its subsidiaries hitting certain performance targets. Those targets were not met and the second tranche was never disbursed. The debenture pays interest at the rate of 12.15% per annum and matures in 2016.

 

The Company owes Ventana Systems approximately $21,000 under a 2001 promissory note in the original principal amount of approximately $62,000. The note matured in 2003 and has been in default since that time. The Company is currently in negotiations with the parent of Ventana Systems, who also are the holders of 100% of the outstanding shares of Series D preferred stock to convert the note and Series D into common stock of the Company. The Company expects to close on this transaction by the end of 1st quarter of 2015.

 

As of September 30, 2014, an officer had advanced the Company approximately $125,000. During this period the company has paid back $10,000 and imputed approximately $1,700 of non cash charge interest expense on these advances.

 

6. Common Stock

 

In May and June of 2014, the Company issued 12,187,500 shares as part of a follow private placement to the original April 2014 private placement as part of the Medite Enterprise transaction (see Note 2) and raised gross proceeds of $195,000. Additional gross proceeds of $117,188 were received in July 2014 for the issuance of 7,812,350 shares. The company in succession of the original private placement and follow up offering is in process of completing an additional private offering for $800,000.

 

By majority shareholder vote, the company effective November 13, 2014 has registered to increase authorized common stock shares to 3.5 billion shares. During the quarter, the Company’s Board of Directors has also authorized the change of the company’s name from CytoCore Inc. to Medite Cancer Diagnostics, Inc. The Company is in the process of registering the name Medite Cancer Diagnostics with the State of Delaware. The company believes recent approval is imminent from FINRA, the Financial Industry Regulatory Authority approving the company’s name change after filing for approval in July 2014.

 

11
 

  

During the second quarter of 2014, the Company issued 3,589,214 shares of its common stock to one of its vendors in satisfaction of a $36,000 liability to the vendor.

 

During the second quarter of 2014, the Company issued 4,877,111 shares of its common stock to former directors and consultants in satisfaction of certain liabilities owed them for their services in the amount of $82,000.

 

7. Preferred Stock

 

A summary of the Company’s preferred stock is as follows:

 

   September 30, 
   2014 
   Shares Issued & 
Offering  Outstanding 
     
Series A convertible   47,250 
Series B convertible, 10% cumulative dividend   93,750 
Series C convertible, 10% cumulative dividend   38,333 
Series D convertible, 10% cumulative dividend   175,000 
Series E convertible, 10% cumulative dividend   19,022 
Total Preferred Stock   373,355 

 

As of September 30, 2014, the Company had cumulative preferred undeclared and unpaid dividends. In accordance with the Financial Accounting Standard Board’s Accounting Standards Codification 260-10-45-11, “Earnings per Share”, these dividends were added to the net loss in the net loss per share calculation.

 

Summary of Preferred Stock Terms

 

Series A Convertible Preferred Stock
Liquidation Value: $4.50 per share, $212,625
Conversion Price: $103.034 per share
Conversion Rate: 0.04367—Liquidation Value divided by Conversion Price ($4.50/$103.034)
Voting Rights: None
Dividends: None
Conversion Period: Any time
   
Series B Convertible Preferred Stock
Liquidation Value: $4.00 per share, $375,000
Conversion Price: $10.00 per share
Conversion Rate: 0.40—Liquidation Value divided by Conversion Price ($4.00/$10.00)
Voting Rights: None
Dividends: 10%—Quarterly—Commencing March 31, 2001
Conversion Period: Any time
Cumulative and undeclared dividends in arrears at September 30, 2014 were $510,206
   
Series C Convertible Preferred Stock
Liquidation Value: $3.00 per share, $115,000
Conversion Price: $6.00 per share
Conversion Rate: 0.50—Liquidation Value divided by Conversion Price ($3.00/$6.00)
Voting Rights: None
Dividends: 10%—Quarterly—Commencing March 31, 2002
Conversion Period: Any time
Cumulative and undeclared dividends in arrears at September 30, 2014 were $148,514

 

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Series D Convertible Preferred Stock
Liquidation Value: $10.00 per share, $1,750,000
Conversion Price: $10.00 per share
Conversion Rate: 1.00—Liquidation Value divided by Conversion Price ($10.00/$10.00)
Voting Rights: None
Dividends: 10%—Quarterly—Commencing April 30, 2002
Conversion Period: Any time
Cumulative and undeclared dividends in arrears at September 30, 2014 were $656,250
   
Series E Convertible Preferred Stock
Liquidation Value: $22.00 per share, $418,488
Conversion Price: $8.00 per share
Conversion Rate: 2.75—Liquidation Value divided by Conversion Price ($22.00/$8.00)
Voting Rights: Equal in all respects to holders of common shares
Dividends: 10%—Quarterly—Commencing May 31, 2002
Conversion Period: Any time
Cumulative and undeclared dividends in arrears at September 30, 2014 were $547,624

 

8. Commitments and Contingencies

 

The Company currently leases warehouse space in Germany under a month to month operating lease with a monthly rental fee of 4,000 euro. The Company currently has 12 vehicles it leases for delivery and other purposes with expirations ranging from April 2014 through August 2015. In July 2013, the Company entered into a lease agreement for administrative office and warehouse space. The lease has a term of 5 years and requires minimum monthly rental payments starting at $2,277 per month increasing to $2,563 per month in year 5. No amounts were recorded for deferred rent for the rent escalation clauses as they were immaterial in 2014 and 2013. In total the leases require minimum monthly rental payments of approximately 5,100 euros.

 

The Company is currently in the process of obtaining default judgments against a number of customers who have defaulted on repayment on their outstanding invoices and the purchaser of a former subsidiary for non-payment. The total amount currently awaiting default judgments is approximately 428,000 euros. While the Company believes that it may recover substantially all of the amounts outstanding through the enforcement of the judgments, it currently has included reserves for 100% of the amounts owed as of March 31, 2014 and December 31, 2013 due to the difficulty of enforcement of any judgments obtained, especially across international borders.

 

On September 9, 2014, an amended complaint was filed against the Company in the United States District Court for the District of New Jersey by D&D Technology, Inc. (“D&D”) alleging, among other things, that the Company failed to pay amounts due for services rendered by D&D, a company that the Company engaged to design a device for the potential early detection of cancer.  The complaint seeks unspecified monetary damages and equitable relief, including a declaration that D&D owns the device.  On November 7, 2014, the Company filed an answer, counterclaim and third party claim denying the substantive allegations therein and seeking monetary damages and equitable relief, including a declaration that the Company owns the device and compelling the device be turned over to the Company, against D&D and certain employees of D&D

 

9. Segment Information

 

The Company operates in one operating segment. However, the Company has assets and operations in the United States and Germany. The following tables show the breakdown of our operations and assets by Country (in thousands):

 

   United States   Germany 
   September 30, 2014   September 30, 2014 
           
Total Assets  $13,610   $8,231 
Property & equipment, net  $18   $2,079 
Goodwill  $12,461    - 

 

   United States   Germany 
   Nine Month Ended   Nine months Ended 
   September 30,
2014
   September 30,
2013
   September 30,
2014
   September 30,
2013
 
                 
Revenues  $1,321   $333    7,373    6,769 
Net income (loss)   (182)   (116)   232    326 

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Caution Regarding Forward-Looking Statements

 

This report contains “forward-looking statements” – that is, statements related to future, not past, events. In this context, forward-looking statements often address our expected future business and financial performance and financial condition, and often contain words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek,” “see,” or “will.” These forward-looking statements are not guarantees and are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. For us, particular uncertainties that could cause our actual results to be materially different than those expressed in our forward-looking statements include: our ability to raise capital; our ability to retain key employees; our ability to engage third party distributors to sell our products; economic conditions; technological advances in the medical field; demand and market acceptance risks for new and existing products, technologies, and healthcare services; the impact of competitive products and pricing; U.S. and international regulatory, trade, and tax policies; product development risks, including technological difficulties; ability to enforce patents; and foreseeable and unforeseeable foreign regulatory and commercialization factors, our ability to develop new products and respond to technological changes in the markets in which we compete, our ability to obtain government approvals of our products, our ability to market our products, changes in third-party reimbursement procedures, and such other factors that may be identified from time to time in our Securities and Exchange Commission ("SEC") filings and other public announcements including those set forth under the caption “Risk Factors” in Part 1, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2013. All subsequent written and oral forward-looking statements attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by the foregoing. Readers are cautioned not to place undue reliance on our forward-looking statements, as they speak only as of the date made. Except as required by law, we assume no duty to update or revise our forward-looking statements.

 

Overview of CytoCore, Inc.

 

CytoCore, Inc. (the “Company”, “we” or “us”) is a high-tech company specializing in the engineering, manufacturing and marketing of premium medical devices and consumables for detection, risk assessment and diagnosis of cancer and related diseases.

 

We have developed an integrated family of cost-effective products for the detection, diagnosis and treatment of cancer under the trade name of CytoCore Solutions®. Currently, we have one Cytocore Solutions product for sale – our SoftPap collector. Cytocore Solutions is developing, and plans to sell an integrated family of cost-effective products for the detection, diagnosis and treatment of cancer. Cytocore Solutions’ products are intended to address sample collection, specimen preparation, specimen evaluation (including detection/screening and diagnosis), and patient treatment and monitoring within vertical markets related to specific cancers. Current CytoCore Solutions’ products are focused upon cervical cancer. We plan to expand our focus to include other gynecological cancers as well as bladder, lung and breast cancers, among others. Within each of these markets, we anticipate that the CytoCore Solutions products will be sold as individual value-added drop-in replacements for existing products and as integrated systems that improve the efficiency and effectiveness of clinical and laboratory operations.

 

The science of medical diagnostics has advanced significantly during the past decade. Much of this advance has come as a result of new knowledge of the human genome and related proteins, which form the foundation of cell biology and the functioning of the human body. Our goal is to utilize this research as a base to develop screening and diagnostic testing products for cancer and cancer-related diseases. We believe that the success of these products will improve patient care through more accurate test performance, wider product availability and more cost-effective service delivery. We have developed the SoftPAP®, a sample collection device approved by the U.S. Food and Drug Administration, and have developed other collection devices. We are focusing on the development and testing of assay markers and stains for use with imaging system to screen for various cancers.

 

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On April 3, 2014, we acquired 100% of the issued and outstanding capital stock of Medite Enterprise, Inc. and its wholly owned subsidiaries (“MEDITE”). MEDITE specializes in the development, manufacture and distribution of medical laboratory automation equipment and supplies for pathology, histology and cytology. MEDITE’s focus is on the development of medical devices for the detection, risk assessment and diagnosis of cancer and related diseases.

 

MEDITE was founded in 1978. Since 2006, MEDITE’s strategic focus has centered on the development of new devices and consumable products from major R&D investments financed mainly internally from profits and traditional bank financing. The marketing of products is focused on the three major international markets of North America, Europe and China. It has direct sales structures in the United States and Germany and distributors in more than 70 countries around the world. Uses of the devices and consumables include histology and cytology laboratories which are part of a single hospital or a group of hospitals and independent laboratories run individually or as part of a larger group. The structure varies depending on the individual country. For example, the United States has many privately owned and managed health care institutions many of which use group purchase organizations. In some countries purchase of equipment in the health care industry is made by public tender.

 

MEDITE’s current revenue is generated primarily in Europe. With new distribution contracts in the US and China, we expect that these two markets to increasingly contribute more sales.

 

Due to the wide diversification of countries we are selling to along with the diversification of devices and consumables, both in histology and cytology, provides some level of stability and changes in regulations effecting one country, region or product line will not influence our overall business dramatically.

 

The focus of our current R&D is to develop devices for histology and cytology labs which offer a higher level of automation and standardization. Together with our Chinese joint venture partner, we are also working on the digitalization of slides. We have filed several patent applications in connection with this technology. On the consumable side, we are focusing in two directions. One direction is the replacement of popular competitive consumable products with better and cheaper alternatives. The second direction is the development of new revolutionary solutions for popular cancer types such as cervical and breast cancer. We believe that the markers that we have developed for detecting these type of cancers will be more effective than existing solutions in detecting earlier signs before the cancer has developed.

 

Cancer is a major threat for mankind and the recently published “World Cancer Report 2014” by the World Health Organization, states that the number of cases will increase by about 57% to 22 million cases in the next two decades. At the same time cancer deaths will rise from 8.2 million to 13 million per year. We believe that our current products and products under development will help to diagnose cancer earlier and make treatments more efficient to save human lives. The current focus is in the histology (using tissue) and cytology (using cells) segments. For anatomic pathology labs, we are a one stop supplier with all the necessary equipment and consumables. In the cytology segment we are both providing liquid based cytology products from cell collection to cell processing for cervical and other types of cancer screening.

 

Outlook

 

Following the acquisition of MEDITE, our goal is to both grow the MEDITE business and guide the development of CytoCore Solutions technology into marketable products and generate synergies between both these complimentary product lines to increase competitiveness. We believe that the turnaround of the CytoCore product line should be possible within a year. We are also working on reducing expenses of research work, including relocating the laboratory form downtown Chicago to a more economical location outside the city.

 

The recent launch of new products, the positive impact from several new initiatives, and some recently executed distribution contracts in the United States, Europe and China are the underlying factors of growth and profitability.

 

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Results and Operations

 

The following discussion and analysis should be read in conjunction with our unaudited consolidated financial statements presented in Part I, Item 1 of this Quarterly Report and the notes thereto, and our audited consolidated financial statements and notes thereto, as well as our Management’s Discussion and Analysis contained in our Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on April 14, 2014.

 

The results of the Company for the three and nine months ended September 30, 2014 include the results of Medite Enterprise, Inc. for the entire three and nine months periods and the results of CytoCore, Inc. for the period from April 4, 2014 through September 30, 2014. The results of the Company for the comparable three and six month periods ended September 30, 2013 include only the results of Medite Enterprise, Inc.

 

Three months ended September 30, 2014 as compared to the three months ended September 30, 2013

 

Revenue

 

Revenue for the three months ended September 30, 2014 was $2,785 million vs. $2,622 million for the three months ended September 30, 2013. This is a 6% increase from the previous year and was primarily due to newly launched cytology products along with new distribution contracts. Usually the third quarter is seasonally weak due to the summer vacation period which extends from July into September for many countries worldwide.

 

Costs of Sales

 

Cost of revenues were $1,198 million for the three months ended September 30, 2014 vs. $1,026 million for the three months ended September 30, 2013. Sales of lower margin products resulted in a decreased gross margin of 3.9%.

 

Research and Development

 

The addition of Cytocore research and development personnel along with additional expenses involving product development contributed to the greater than 500% increase.

 

Selling, General and Administrative

 

As a percentage of sales expenses increased from 43% to 45% mainly due to the addition of Cytocore personnel. The Company has significantly decreased by over 50% the cost structure of CytoCore. Since the acquisition, we continually look to rationalize our overall cost structure with respect to our operations.

 

Income from Operations before Income Taxes

 

The loss of $0.111 million vs a profit of $0.278 million mainly resulted from the increase in research and development expenses. Research and development spending will decrease as a percentage of sales as future sales growth increases due to the introduction of new products. Investment in research and development will remain as an important competitive strategy.

 

Interest Expenses

 

Interest expenses increased slightly to $0.071 million in the three months ended September 30, 2014 vs. $0.059 million for the three months ended September 30, 2013 due to the increased use of lines of credit to finance working capital.

 

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Nine months Ended September 30th, 2014 as compared to Nine Month Ended September 30th, 2013

 

Revenue

 

Revenue for the first nine months of 2014 is $8.694 million of which $0.001 million came from CytoCore sales and the $8.693 million balance from Medite Enterprise, Inc. This is a 22% increase from the $7.102 million for the nine months ended September 30, 2013, which was due primarily to newly launched cytology products and new distribution contracts. As discussed in the Outlook statement, the first nine months of the year is usually contributes about 65% of annual revenues.

 

Cost of Revenues

 

Gross margins decreased 4% due to the sales of lower margin products. Margins should improve based upon recent introduction of new products as they become a higher percentage of over all sales and increase the historical sales growth rate.

 

Research and Development

 

Research and development costs for the nine months ended September 30, 2014 of $0.762 million as compared to $0.525 million for the nine months ended September 30, 2013. As a percentage to revenue research and development increased to 8.8% compared to 7.4% in the previous year. Research and development expenses are expected to increase at a slower rate than the growth of sales which increases the overall margin. Investment in research and development will continue to be an important part of our strategy.

 

Selling General and Administrative

 

Expenses as a percentage of revenues decreased from 33% to 37%. The company will continue to leverage its overall cost structure as selling, general and administrative become a smaller percent of sales. The growth in expenses decreased as a percentage of sales even though additional administrative cost were incurred due to the integration of CytoCore.

 

Operating Income

 

Operating income as a percentage of sales decreased 2% from 7 to 5.15%. The addition of CytoCore Research and Development along with administrative expenses has reduced profitability by $360,000 for the first 9 months of the year. Costs related to the acquisition have been substantially decreased and will become a smaller percentage of future sales as growth expands with the sales of new higher margin products.

 

Interest Expenses

 

The interest expenses increased slightly to $0.221 million due to the continuous use of lines of credit to finance working capital.

 

Liquidity and Capital Resources

 

During the nine months ended September 30, 2014 we raised approximately $1.841 million in private offerings of 115,587,350 shares of our common stock to accredited investors. We closed on the first $1.529 million upon consummation of the merger with Medite Enterprise, Inc. and closed on $0.195 million throughout the second quarter and the final $0.117 million in the third quarter of 2014. We used a portion of these funds to satisfy certain legacy liabilities of CytoCore of approximately $0.3 million and the remainder was invested into our working capital and property, plant and equipment to fund our growth.

 

Our business requires a substantial investment in working capital primarily inventory and accounts receivable. In the nine months ended September 30, 2014, we invested approximately $1.058 million to increase our available inventory for cytology products. In addition, we invested approximately $0.391 million in new property, plant and equipment in order to meet our customer needs.

 

At the time of our acquisition of MEDITE, CytoCore had accounts payable and accrued expenses of approximately $2.9 million. Of that amount, it was agreed that approximately $0.9 million was subject to a payment agreement that required we obtain significant equity financing before we would be obligated to pay the amounts due. In addition, the amount above includes approximately $0.7 million owed to our current CFO for prior year wages dating back to 2009 which we are still negotiating with him regarding form and timing of payment.

 

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We expect that we will continue to seek additional equity and possibly debt financing in order to meet our expected growth targets. No assurance can be given that any form of additional financing will be available on terms acceptable to the Company, that adequate financing will be obtained by the Company, in order to meet its needs, or that such financing would not be dilutive to existing shareholders.

 

Off-Balance Sheet Arrangements

 

As of September 30, 2014, we did not have any relationships with unconsolidated entities or financial partners, such as entities often referred to as structured finance or special purpose entities established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in such relationships.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Our chief executive officer and our chief financial officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended, the “Exchange Act”) as of the end of the period covered by this report. Based on that evaluation, our chief executive and chief financial officers have concluded that our disclosure controls and procedures were not effective to provide reasonable assurance that the information we are required to disclose in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and accumulated and communicated to our management, including our chief executive officer and chief financial officer, as appropriate to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

In April 2014, the Company consummated a merger with Medite Enterprise Inc. Our financial reporting now involves those individuals from Medite Enterprise, Inc. and the reporting associated with the merged companies. Joseph Totoro’s employment as controller for CytoCore, Inc. was initiated in April 2014 and Robert McCullough Jr. is now the Chief Financial Officer of the Company. As a condition of the merger, the prior owners of Medite Enterprise, Inc. are now the Chief Operating Officer and Chief Executive Officer of the Company.

 

Part II. Other Information

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

During the quarter ended September 30, 2014, the Company sold 7,812,350 shares of restricted, unregistered common stock to qualified investors for approximately $117,000 or $0.016 per share.

 

We issued the foregoing securities in reliance on the safe harbor and exemptions from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, for sales to a limited number of accredited investors, employees, service providers, or creditors with whom we had prior relationships, without engaging in any general solicitation, and without payment of underwriter discounts or commissions to any person.

 

Item 3. Defaults upon Senior Securities

 

As of September 30, 2014, we failed to make the required principal and interest payments, constituting events of default, on the $21,000 Ventana Medical Systems, Inc.(“Ventana”) promissory note. The note requires the holder to notify us in writing of a declaration of default at which time a cure period, as specified in the note, would commence. There is no guarantee that we will be able to cure any event of default if, or when, the holder provides the required written notice. The Company is currently in negotiations with the parent of Ventana to exchange all of the issued and outstanding shares of Series D preferred stock and cumulative preferred dividend, which are held by Ventana, and to convert the entire outstanding principal balance and accrued interest into shares of the Company’s common stock. The Company expects to complete the exchange and conversion in the first quarter of 2015.

 

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Item 6. Exhibits

 

Exhibit  
Number Description
   
31.1 Section 302 certification by the principal executive officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
   
31.2 Section 302 certification by the chief financial officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
   
32.1 Section 906 certification by the principal executive pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
   
32.2 Section 906 certification by the chief financial officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
   
101.INS XBRL Instance
   
101.SCH XBRL Taxonomy Extension Schema
   
101.CAL XBRL Taxonomy Extension Calculation
   
101.DEF XBRL Taxonomy Extension Definition
   
101.LAB XBRL Taxonomy Extension Labels
   
101.PRE XBRL Taxonomy Extension Presentation

 

19
 

 

 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  CytoCore, Inc.
   
Date:  November 19, 2014 /s/ Michaela Ott
    Michaela Ott
    Chief Executive Officer
     
     
Date: November 19, 2014 /s/ Robert F. McCullough, Jr.
    Robert F. McCullough, Jr.
    Chief Financial Officer

 

20
 

 

EXHIBIT INDEX

 

Exhibit  
Number Description
   
31.1 Section 302 certification by the principal executive officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
   
31.2 Section 302 certification by the chief financial officer pursuant to Rules 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.
   
32.1 Section 906 certification by the principal executive officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
   
32.2 Section 906 certification by the chief financial officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.
   
101.INS XBRL Instance
   
101.SCH XBRL Taxonomy Extension Schema
   
101.CAL XBRL Taxonomy Extension Calculation
   
101.DEF XBRL Taxonomy Extension Definition
   
101.LAB XBRL Taxonomy Extension Labels
   
101.PRE XBRL Taxonomy Extension Presentation

 

21