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 June 30, 2015
¨	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 000-00935

 

MEDITE CANCER DIAGNOSTICS, 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 34 th Street, Orlando, FL	32811
(Address of principal executive offices)	(Zip Code)

 

(407) 996-9630

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class		Name of each exchange on which registered
None		Not Applicable

 

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 ¨

 

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 ¨ (not required) ¨

 

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 ¨	Accelerated Filer  ¨
Non-Accelerated Filer ¨	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 ¨ 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 August 13, 2015: 20,391,206

 

 

MEDITE Cancer Diagnostics, Inc.

 

Form 10-Q

 

For the Quarterly Period Ended June 30, 2015

 

TABLE OF CONTENTS

 

		Page
PART I.  – FINANCIAL INFORMATION
Item 1.	Financial Statements
a) Condensed Consolidated Balance Sheets – June 30, 2015 (unaudited) and December 31, 2014		3
b) Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) — Three and Six months Ended June 30, 2015 and 2014 (unaudited)		4
c) Condensed Consolidated Statements of Cash Flows – Six months ended June 30, 2015 and June 30, 2014 (unaudited)		6
d) Notes to Condensed Consolidated Financial Statements (unaudited)		7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 4.	Controls and Procedures	17
PART II. — OTHER INFORMATION
Item 1.	Legal Proceedings	20
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	20
Item 3.	Defaults upon Senior Securities	20
Item 6.	Exhibits	21
SIGNATURES		22
EXHIBIT INDEX
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 32.2     Section 906 Certification of Chief Financial Officer

 

 

PART I. — FINANCIAL INFORMATION

 

MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Dollars in thousands except shares and per share amounts)

 

		June 30,				December 31,
		2015				2014
		(unaudited)
Assets
Current assets:
Cash and cash equivalents		$	247			$	230
Accounts receivable, net			1,643				1,991
Inventories			3,655				3,415
Prepaid expenses and other current assets			82				154
Total current assets			5,627				5,790
Property and equipment, net			1,964				2,091
In-process research and development			4,620				4,620
Trademarks, trade names			1,240				1,240
Goodwill			2,453				2,453
Other assets			384				245
Total assets		$	16,288			$	16,439
Liabilities and Stockholders’ Equity
Current liabilities:
Secured lines of credit and current portion of long-term debt		$	1,905			$	2,555
Account payable and accrued expenses			3,995				4,134
Advances – related parties			95				110
Total current liabilities			5,995				6,799
Long-term debt, net of current portion			853				1,209
Total liabilities			6,848				8,008
Commitments and contingencies
Stockholders’ equity :
Preferred stock, $0.001 par value; 10,000,000 shares authorized; 198,355 and 373,355 shares issued and outstanding as of June 30, 2015 and December 31, 2014, respectively (liquidation value of all classes of preferred stock $1,121 and $2,871 as of June 30, 2015 and December 31, 2014, respectively)			962				1,487
Common stock, $0.001 par value; 3.5 billion shares authorized, 20,391,206 and 19,427,331 issued and outstanding as of June 30, 2015 and December 31, 2014, respectively			20				19
Additional paid-in capital			7,784				5,763
Treasury stock			(327	)			(327	)
Accumulated other comprehensive loss			(309	)			(149	)
Retained earnings			1,310				1,638
Total stockholders’ equity			9,440				8,431
Total liabilities and stockholders’ equity		$	16,288			$	16,439

 

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

 

 

MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Dollars in thousands, except shares and per share amounts)

 

		Three Months Ended June 30,
		2015				2014
		(unaudited)				(unaudited)
Net sales		$	2,132			$	3,175
Cost of revenues			1,166				1,441
Gross profit			966				1,734
Operating expenses
Depreciation and amortization expense			31				39
Research and development			341				246
Selling, general and administrative			600				1,333
			972				1,618
Total operating expenses
Operating income (loss)			(6	)			116
Other expenses
Interest expense			54				75
Other expenses			-				122
Total other expenses			54				197
Loss before income taxes			(60	)			(81	)
Income tax expense (benefit)			13				(31	)
Net loss			(73	)			(50	)
Preferred dividend			(23	)			(36	)
Net loss to common stockholders		$	(96	)		$	(86	)
Condensed statements of comprehensive income (loss)
Net loss			(73	)			(50	)
Other comprehensive loss
Foreign currency translation adjustments			87				(4	)
Comprehensive income (loss)		$	14			$	(54	)
Earnings per share
Net loss to common stockholders			(96	)			(86	)
Basic and diluted earnings (loss) per share			-				-
Weighted average basic and diluted shares outstanding			20,328,495				16,349,483

 

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

 

 

MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

(Dollars in thousands, except shares and per share amounts)

 

		Six Months Ended June 30,
		2015				2014
		(unaudited)				(unaudited)
Net sales		$	4,419			$	5,909
Cost of revenues			2,535				2,938
Gross profit			1,884				2,971
Operating expenses
Depreciation and amortization expense			65				78
Research and development			603				445
Selling, general and administrative			1,407				1,962
Total operating expenses			2,075				2,485
Operating income (loss)			(191	)			486
Other expenses
Interest expense			111				150
Other expenses			50				151
Total other expenses			161				301
Income (loss) before income taxes			(352	)			185
Income tax expense (benefit)			(25	)			16
Net income (loss)			(327	)			169
Preferred dividend			(46	)			(36	)
Net income (loss) to common stockholders		$	(373	)		$	133
Condensed statements of comprehensive income (loss)
Net income (loss)			(327	)			169
Other comprehensive loss
Foreign currency translation adjustments			(160	)			(4	)
Comprehensive income (loss)		$	(487	)		$	165
Earnings (loss) per share
Net income (loss) to common stockholders			(373	)			133
Basic and diluted earnings (loss) per share			(.02	)			-
Weighted average basic and diluted shares outstanding			20,018,269				15,527,624

 

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

 

 

MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in thousands)

 

		Six Months Ended June 30,
		2015				2014
		(unaudited)				(unaudited)
Cash flows from operating activities:
Net income (loss)		$	(327	)		$	169
Adjustments to reconcile net income (loss) to net cash used in operating activities
Depreciation and amortization			65				78
Non cash interest			-				2
Deferred income taxes			(139	)			-
Changes in assets and liabilities:
Accounts receivable, net			348				(247	)
Inventories			(240	)			(827	)
Prepaid expenses and other current assets			71				(78	)
Accounts payable and accrued liabilities			(139	)			(279	)
Net cash used in operating activities			(360	)			(1,182	)
Cash flows from investing activities:
Purchases of equipment			(6	)			(269	)
Increase in other assets			-				1
Net cash used in investing activities			(6	)			(268	)
Cash flows from financing activities:
Net advances (repayments) on lines of credit and long-term debt			(1,008	)			142
Term note repayment			-				(104	)
Proceeds from sale of common stock, net issuance costs of $28			1,496				1,724
Net advances (repayments) from related parties			(15	)			21
Net cash provided by financing activities			473				1,783
Effect of exchange rates on cash and cash equivalents			(90	)			(94	)
Net increase (decrease) in cash and cash equivalents			17				(239	)
Cash and cash equivalents at beginning of year			230				75
Cash and cash equivalents at end of the period		$	247			$	314
Supplemental disclosure of cash flow information:
Cash paid for interest		$	102			$	149
Cash paid for income taxes		$	52			$	16
Supplemental schedule of non-cash financing activity:
Conversion of preferred stock to common stock		$	525			$	-

 

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

 

 

MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Tabular data in thousands, except shares and per share amounts)

 

Note 1.

Organization and Summary of Significant Accounting Policies

 

MEDITE Cancer Diagnostics, Inc., (“MDIT”, “MEDITE” or the “Company”) was incorporated in Delaware in December 1998.

 

These statements include the accounts of MEDITE Cancer Diagnostics, Inc., (former 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, MEDITE sp. z o.o., Zilona-Gora, Poland and CytoGlobe, GmbH, Burgdorf, Germany.

 

In April 2014, 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 14,687,500 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., now MEDITE Cancer Diagnostics, Inc.         

 

MEDITE is a medical technology company specializing in the development, engineering, manufacturing and marketing of premium medical devices and consumables for detection, risk assessment and diagnosis of cancer and related diseases. By acquiring MEDITE the company changed from solely research operations to an operating company with 76 employees in four countries, a distribution network to about 70 countries worldwide, a well-known and established brand name, a wide range of selling products and the established infrastructure necessary for a company acting in the medical industry.

 

Consolidation, Basis of Presentation and Significant Estimates

 

The accompanying condensed consolidated financial statements for the periods ended June 30, 2015 and 2014 included herein are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). 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, 2015 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 disclosed in the Report on Form 10-K/A for the year ended December 31, 2014 and other filings with the Securities and Exchange Commission.

 

The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant inter-company balances and transactions have been eliminated in consolidation. 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. 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, 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, segregating the items packaged 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.

 

 

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.

 

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	3-10 yrs
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.

 

Acquired In-Process Research and Development

 

Acquired in-process research and development (“IPR&D”) that the Company acquires through business combinations represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, MEDITE will make a determination as to the then useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company tests IPR&D for impairment at least annually, or more frequently if impairment indicators exist, by first assessing qualitative factors to determine whether it is more likely than not that the fair value of the IPR&D intangible asset is less than its carrying amount. If the Company concludes it is more likely than not that the fair value is less than the carrying amount, a quantitative test that compares the fair value of the IPR&D intangible asset with its carrying value is performed. If the fair value is less than the carrying amount, an impairment loss is recognized in operating results.

 

Impairment or Disposal of Long-Lived Assets Including Finite Lived Intangibles

 

At each balance sheet date or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable, management of the Company evaluates the recoverability of such assets. An impairment loss is recognized if the amount of undiscounted cash flows is less than the carrying amount of the asset, in which case the asset is written down to fair value. The fair value of the asset is measured by either quoted market prices or the present value of estimated expected future cash flows using a discount rate commensurate with the risks involved. Unless events or circumstances have changed significantly, we generally do not re-test at year end assets acquired from a business combination in the year of acquisition.

 

Impairment of Indefinite Lived Intangible Assets Other Than Goodwill

 

The Company has the option first to assess qualitative factors to determine whether the existence of events and circumstances indicates that it is more likely than not that the indefinite-lived intangible asset is impaired. If, after assessing the totality of events and circumstances, the Company concludes that it is not more likely than not that the indefinite-lived intangible asset is impaired, then the entity is not required to take further action. However, if the Company concludes otherwise, then it is required to determine the fair value of the indefinite-lived intangible asset and perform the quantitative impairment test by comparing the fair value with the carrying amount in accordance with Financial Accounting Standards Board Codification Subtopic 350-30.

 

 

Goodwill

 

The Company allocates goodwill to reporting units based on the reporting unit expected to benefit from the business combination. The Company evaluates our reporting units on an annual basis. Goodwill is tested for impairment at the reporting unit level (operating segment or one level below an operating segment) on an annual basis (December 31) and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying value. These events or circumstances could include a significant change in the business climate, legal factors, operating performance indicators, competition, or sale or disposition of a significant portion of a reporting unit. Unless events or circumstances have changed significantly, we generally do not re-test at year end assets acquired from a business combination in the year of acquisition.

 

Application of the goodwill impairment test requires judgment, including the identification of reporting units, assignment of assets and liabilities to reporting units, assignment of goodwill to reporting units, and determination of the fair value of each reporting unit. The fair value of each reporting unit is estimated using a discounted cash flow methodology. This analysis requires significant judgments, including estimation of future cash flows, which is dependent on internal forecasts, estimation of the long-term rate of growth for our business, estimation of the useful life over which cash flows will occur, and determination of our weighted average cost of capital.

 

Impairment Policy and Procedures for In Process Research and Development, Trademarks, Trade Names and Goodwill

 

The estimates used to calculate the fair value of a reporting unit change from year to year based on operating results, market conditions, and other factors. Changes in these estimates and assumptions could materially affect the determination of fair value and goodwill impairment for each reporting unit.

 

These assets were independently valued at April 3, 2014, the date of the MEDITE Enterprise, Inc. purchase by CytoCore, Inc., based upon valuation assumptions such as projected discounted cash-flow amongst others and updated through June 30, 2015. In the future, the Company plans to review the assumptions annually to determine if any impairment allowances are necessary until the underlying products under development and long-lived assets have been commercialized.

 

Recent Accounting Pronouncements

 

In 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): “Simplifying the Measurement of Inventory”. The amendments require an entity to measure in scope inventory at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The Company does not expect this amendments to have a material impact on its consolidated financial statements.

 

In February 2015, the FASB issued ASU 2015-02, Consolidation (Topic 810): Amendments to the Consolidation Analysis, which is intended to improve targeted areas of the consolidation guidance for legal entities such as limited partnerships, limited liability corporations and securitization structures. The amendments in the ASU affect the consolidation evaluation for reporting organizations and simplifies the current US GAAP requirements by reducing the number of consolidation models. The guidance is effective for fiscal years and interim reporting periods beginning on or after December 15, 2015. The Company does not expect this standard to have a material impact on its statements of operations, statements of cash flows or financial position.

 

In May 2014, the FASB issued ASU 2014-09, “Revenue with Contracts from Customers.” ASU 2014-09 supersedes the current revenue recognition guidance, including industry-specific guidance. The ASU introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods and services. The updated guidance is effective for public entities for interim and annual periods beginning after December 15, 2016 and early adoption is not permitted. The Company is currently evaluating the impact of the updated guidance, but the Company does not believe that the adoption of ASU 2014-09 will have a significant impact on its consolidated financial statements.

 

Note 2.

Reverse Merger

 

In January 2014, the Company and the previous owners of MEDITE Enterprise, Inc. entered into an agreement to merge with the former 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 697,234 shares of its common stock in satisfaction of approximately $1.6 million in outstanding accrued payroll. On April 4, 2014 the Company closed on a private placement in which it received gross proceeds of $1.5 million and issued 955,875 shares of its common stock. The merger closed on April 4, 2014 with the previous owners of MEDITE Enterprise, Inc. receiving 14,687,500 shares of the Company’s common stock. An additional 312,500 shares remain to be issued because certain conditions have been fulfilled in accordance with the agreement to complete the exchange for 100% of the issued and outstanding stock of MEDITE Enterprise, Inc. The consideration paid was determined based upon the number of shares outstanding from the former CytoCore, Inc. of approximately 3,502,700 common shares outstanding before the merger at $1.60 per share (the same price per share in the concurrent private placement noted above).

 

Because the owners of MEDITE Enterprise, Inc. received approximately 81.1% of the then issued and outstanding stock of the Company, the merger was treated as a reverse acquisition, in which for accounting purposes MEDITE Enterprise, Inc. acquired CytoCore, Inc. Therefore, the consolidated statements of operations and comprehensive income (loss) for the three months and six month ended June 30, 2015 represents the financial results of MEDITE Enterprise, Inc. and subsidiaries only as the transaction did not occur until April 4, 2014.

 

 

Under the purchase method of accounting, the assets acquired and liabilities assumed are recorded at their respective fair values as of the transaction date. In connection with the merger, the consideration paid, the assets acquired and liabilities assumed, recorded at fair value on the date of acquisition, are summarized in the following table:

 

		In thousands
Assets acquired
Cash		$	1
Other current assets			12
Property and equipment			81
Trade names /trademarks			1,240
In-Process research and development			4,620
Goodwill			2,453
			8,407
Liabilities assumed
Accounts payable & accrued expenses			3,220
Related party advances			102
Loans payable			21
			3,343
Consideration paid in the form of common stock		$	5,064

 

The Company is treating the fair value assigned to trade names/trademarks as indefinite lived intangibles. The in process research and development covers four separate areas (a) breast pap device and related consumables (b) new biomarkers (c) a new stain and (d) the SoftKit. Until the Company either completes development or abandons such development, the in-process research and development costs are treated as indefinite lived intangible assets. If the Company is successful in these development projects, it expects the in-process research and development will be amortized over an approximate 15 year life.

 

Note 3.

Inventories

 

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

 

		June 30,				December 31,
		2015				2014
		(unaudited)
Raw materials		$	1,515			$	1,229
Work in progress			165				33
Finished Goods			1,975				2,153
		$	3,655			$	3,415

 

No amounts were reserved for obsolete inventory as of June 30, 2015 and December 31, 2014.

 

 

Note 4.

Property and Equipment

 

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

 

		June 30,				December 31,
		2015				2014
		(unaudited)
Land		$	212			$	233
Buildings			1180				1,291
Machinery and equipment			540				529
Office furniture and equipment			286				265
Vehicles			31				103
Computer equipment			105				110
Construction in progress			510				559
Less: Accumulated depreciation			(900	)			(999	)
		$	1,964			$	2,091

 

Depreciation expense amounted to approximately $65,000 and $78,000 for the six months ended June 30, 2015 and 2014, respectively.

 

Note 5.

Long-term Debts and Lines of Credit

 

The Company’s outstanding note payable indebtedness was as follows as of (in thousands):

 

		June 30,				December 31,
		2015				2014
		(unaudited)
Hannoversche Volksbank credit line #1		$	1,163			$	1,880
Hannoversche Volksbank credit line #2			384				465
Hannoversche Volksbank term loan #1			93				135
Hannoversche Volksbank term loan #2			49				81
Hannoversche Volksbank term loan #3			216				270
Ventana Medical Systems, Inc. Promissory Note			21				21
Denture DZ Equity Partners Participation right			832				912
		$	2,758			$	3,764

 

In July 2006, MEDITE GmbH, Burgdorf, entered into a master line of credit agreement #1 with Hannoversche Volksbank. The line of credit was amended in 2012 and was later amended to increase the credit limit to Euro 1.8 million ($2.0 million as of June 30, 2015). In January 2015, the master credit line was reduced to Euro 1.6 million ($1.8 million as of June 30, 2015) and further reduced to the original Euro 500,000 ($554,720 as of June 30, 2015) to Euro 1.1 million ($1.2 million as of June 30, 2015) effective July 1, 2015. Borrowings on the master line of credit agreement #1 bears interest at a variable rate based on Euribor (Euro Interbank Offered Rate) depending on the type of advance elected by the company and defined in the agreement. Interest rates depending on the type of advance elected range from 3.77 – 8.00 % during the period ended June 30, 2015. The line of credit has no stated maturity date. The line of credit is collateralized by the accounts receivable and inventory of MEDITE GmbH, Burgdorf, a mortgage on the buildings owned by the Company and is guaranteed by Michaela Ott and Michael Ott, the former sole shareholders of the Company.

 

In June 2012, CytoGlobe, GmbH, Burgdorf, entered into a line of credit agreement #2 with Hannoversche Volksbank. The line of credit granted a maximum borrowing authority of Euro 400,000 ($443,776 as of June 30, 2015). Borrowings on the master line of credit agreement #2 bears interest at a variable rate based on Euribor (Euro Interbank Offered Rate) depending on the type of advance elected by the Company and defined in the agreement. Interest rates depending on the type of advance elected range from 3.77 – 8.00 % during the period ended June 30, 2015. The line of credit has no stated maturity date. The line of credit is collateralized by the accounts receivable and inventory of CytoGlobe GmbH, Burgdorf and is guaranteed by Michaela Ott and Michael Ott, the former sole shareholders of the Company and the state of Lower Saxony (Germany) to support high-tech companies in the area.

 

In December 2006, MEDITE GmbH, Burgdorf, entered into a Euro 500,000 ($554,720 as of June 30, 2015) term loan agreement #1 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 Euro 27,780 ($30,820 as of June 30, 2015). The term loan is guaranteed by Michaela Ott and Michael Ott, the former sole shareholders of the Company and also a mortgage on the property of the Company. 

 

 

In June 2006, MEDITE GmbH, Burgdorf, entered into a Euro 400,000 ($443,776 as of June 30, 2015) term loan #2 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 Euro 22,220 ($24,652 as of June 30, 2015). The term loan is guaranteed by Michaela Ott and Michael Ott, the former sole shareholders of the Company and is collateralized by subordinated assignments of all of the receivables and inventories of MEDITE GmbH, Burgdorf and also has a subordinated pledge of share term life insurance policies.

 

In November 2008, MEDITE GmbH, Burgdorf, entered into a Euro 400,000 ($443,776 as of June 30, 2015) term loan #3 with Hannoversche Volksbank with a variable interest rate of approximately 4.7% per annum as of December 31, 2014. The term loan has a maturity of December 31, 2018, and requires quarterly principal repayments of Euro 13,890 ($15,410 as of June 30, 2015). The term loan is guaranteed by Michaela Ott and Michael Ott, the former sole shareholders of the Company, and is collateralized by 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 with a mezzanine lender who advanced the Company up to Euro 1.5 million, ($1.7 million as of June 30, 2015) in two tranches of Euro 750,000 each, ($832,000 as of June 30, 2015). 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 called. The debenture pays interest at the rate of 12.15% per annum and matures at December 31, 2016.

 

As of the date of filing, the remaining balance of approximately $21,000 on the note payable to Ventana Medical Systems, Inc. was in default. However, on February 23, 2015, the Company reached an agreement with Ventana Medical Systems, Inc. whereby both parties have agreed that Ventana Medical Systems, Inc. will accept $38,281 as payment in full for all outstanding principal and accrued interest. The $38,281 has been included in current portion of long-term debt on the consolidated balance sheet. As part of this agreement, Ventana Medical Systems, Inc. has agreed to convert $1.75 million stated value of Series D Preferred stock and all outstanding accrued dividends of $656,250 for 12,000 shares of the Company’s common stock. Prior to the execution of this agreement, the Company had failed to make principal and interest payments when due and is in breach of certain warranties and representations under the notes included above.

 

During 2015 the Company reduced their working line and term loans with Hannoversche Volksbank by $1,006 net of currency fluctuations, $666 and $340 in the second and first quarters of 2015, respectively. (See the “liquidity” comment on page 19.)

 

Note 6.

Related Party Advances

 

At June 30, 2015 and December 31, 2014, the Company owed its then CFO and Chairman of the Board for prior advances of approximately $95,000 and $110,000 respectively. The CEO Michaela Ott together with the COO Michael Ott provided an additional non interest bearing short term advance of $950,000 at the end of the first quarter ended March 31, 2015 until equity funds were received. As of the date of the filing, the Company has no balances outstanding due to Michaela and Michael Ott.

 

Note 7.

Common Stock

 

During the first quarter ended March 31, 2015, the Company issued 240,625 shares of unregistered stock to qualified individuals pursuant to exemptions from registration under Regulation D and Section 4(2) of the Securities Act of 1933 at 1.60 for proceeds of $357,000, net of $28,000 of issuance costs. Further, the Company issued 12,000 shares of common stock in a Series D Preferred Stock conversion as further discussed in Note 8. During the second quarter ended June 30, 2015 the Company issued 711,250 shares at $1.60 for proceeds of $1,138,000 to the President of UNIC Medical of China. UNIC is the Company’s distributor in China and other Asian countries.

 

Note 8.

Preferred Stock and Warrants

 

A summary of the Company’s preferred stock as of June 30, 2015 and December 31, 2014 is as follows.

 

		June 30,				December 31,
		2015				2014
		(unaudited)
		Shares Issued &				Shares Issued &
Offering		Outstanding				Outstanding
Series A convertible			47,250				47,250
Series B convertible, 10% cumulative dividend			93,750				93,750
Series C convertible, 10% cumulative dividend			38,333				38,333
Series D convertible, 10% cumulative dividend			-				175,000
Series E convertible, 10% cumulative dividend			19,022				19,022
Total Preferred Stock			198,355				373,355

 

 

As of June 30, 2015 and December 31, 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 for the six months ended June 30, 2015.

 

On February 23, 2015, the Company reached an agreement with Ventana Medical Systems, Inc. to convert $1.75 million stated value of Series D Preferred Stock and all outstanding accrued dividends of $656,250 for 12,000 shares of the Company’s common stock, which was issued in the second quarter ended June 30, 2015.

 

Summary of Preferred Stock Terms

 

Series A Convertible Preferred Stock

Liquidation Value:	$4.50 per share, $212,625
Conversion Price:	$10,303 per share
Conversion Rate:	0.00044—Liquidation Value divided by Conversion Price ($4.50/$10,303)
Voting Rights:	None
Dividends:	None
Conversion Period:	Any time

 

Series B Convertible Preferred Stock

Liquidation Value:	$4.00 per share, $375,000
Conversion Price:	$1,000 per share
Conversion Rate:	0.0040—Liquidation Value divided by Conversion Price ($4.00/$1,000)
Voting Rights:	None
Dividends:	10%—Quarterly—Commencing March 31, 2001
Conversion Period:	Any time

Cumulative dividends in arrears at June 30, 2015 and December 31, 2014 were $539,413 and $520,665, respectively.

  

Series C Convertible Preferred Stock

Liquidation Value:	$3.00 per share, $115,000
Conversion Price:	$600 per share
Conversion Rate:	0.0050—Liquidation Value divided by Conversion Price ($3.00/$600)
Voting Rights:	None
Dividends:	10%—Quarterly—Commencing March 31, 2002
Conversion Period:	Any time

Cumulative dividends in arrears at June 30, 2015 and December 31, 2014 were $157,163 and $151,413, respectively.

 

Series D Convertible Preferred Stock

Liquidation Value:	$1,000 per share, $ 525,000
Conversion Price:	$1,000 per share
Conversion Rate:	.01—Liquidation Value divided by Conversion Price ($10.00/$1,000)
Voting Rights:	None
Dividends:	10%—Quarterly—Commencing April 30, 2002
Conversion Period:	Any time

Cumulative dividends in arrears at June 30, 2015 and December 31, 2014 were $0 and $660,000, respectively.

 

Series E Convertible Preferred Stock

Liquidation Value:	$22.00 per share, $418,488
Conversion Price:	$800.00 per share
Conversion Rate:	.0275—Liquidation Value divided by Conversion Price ($22.00/$800)
Voting Rights:	Equal in all respects to holders of common shares
Dividends:	10%—Quarterly—Commencing May 31, 2002
Conversion Period:	Any time

Cumulative dividends in arrears at June 30, 2015 and December 31, 2014 were $578,639 and $558,173 respectively.

 

Warrants outstanding

 

														Weighted
						Weighted								Average
						Average				Aggregate				Remaining
						Exercise				Intrinsic				Contractual
		Warrants				Price				Value				Life (Years)
Outstanding at December 31, 2014			143,308			$	2.64				—				6.46
Granted			—				—				—				—
Exercised			—				—				—				—
Expired			—				—				—				—
Outstanding at June 30, 2015			143.308			$	2.64				—				6.46

 

 

Note 9.

Commitments and Contingencies

 

The Company currently leases 19 vehicles for sales and service employees, delivery and other purposes with expirations ranging from July 2015 through June 2018. The current minimum monthly payment for these vehicle leases is approximately $6,214.

 

The Company has several operation leases for office, laboratory and manufacturing space. The Company’s operating lease for one of its German facilities can be cancelled by either party with a 3 months’ notice, its Poland facility can be terminated by either party with a six month notice. Monthly rent payments for the German and Poland facilities are Euro 4,000 ($4,465 as of June 30, 2015) and PLN 6,240 ($1,662 as of June 30, 2015) respectively. The Company’s laboratory facility in Chicago, IL terminates June 30, 2016 and requires monthly payments of $1,070. The Company also subleases its former Chicago laboratory facility for $3,948 per month. The lease for this facility terminates October 30, 2016 and requires monthly rent payments of $4,594. The Company’s Orlando facility has escalating rents ranging from $2,345 to $2,563 per month and terminates July 31, 2018. The total aggregate monthly lease payments (net of the sublease) required on these leases is approximately $9,400.

 

The Company also leases IT Hardware and Software for 3-D Design and incurs a monthly lease rate of $1,646.

 

In 2014, the Company became subject to a lawsuit brought by D&D Technologies, Inc. (“D&D”) in the state of New Jersey for breach of contract and breach of implied covenant of good faith that occurred in 2013 and prior by the former CytoCore for failure to pay for past contractual services. The original complaint was dismissed and then refiled by D&D. D&D is seeking damages over $86,000 plus equitable relief. In the second quarter of 2015, the Company and D&D reached a settlement agreement with D&D Technologies, Inc for $15,000. This settlement has been accrued as of June 30, 2015 and included in account payable and accrued expenses on the accompanying condensed consolidated balance sheet. The balance was paid to D&D Technologies by the date of the filling.

 

The Company’s former auditor L.J. Soldinger and Associates filed a claim against the Company in Illinois’ Lake County Superior Court. The Company believes the claims are without merit and is adequately reserved for costs associated with the claim.

 

Note 10.

Segment Information

 

The Company operates in one operating segment. However, the Company has assets and operations in the United States, Germany and Poland. The first quarter numbers included in the six month period ended June 30, 2014 represent Medite as a private company before the reverse merger with the former CytoCore Inc. After April 3, 2014, results reflect the combination of both companies. . The influence by the significant change of the currency exchange rate between USD and EURO since June 30, 2014 compared to June 30, 2015 is approximately $1.1 million. The following tables show the breakdown of the Company’s operations and assets by region (in thousands):

 

		United States								Germany								Poland								Total
		June 30, 2015				December 31, 2014				June 30, 2015				December 31, 2014				June 30, 2015				December 31, 2014				June 30, 2015				December 31, 2014
Assets		$	9,122			$	9,387			$	6,839			$	6,989			$	302			$	63			$	16,263			$	16,439
Property & equipment, net			92				98				1,866				1,985				6				8				1,964				2,091
Intangible assets			8,315				8,313				47				-				7				-				8,369				8,313

 

		United States								Germany								Poland								Total
		June 30, 2015				June 30, 2014				June 30, 2015				June 30, 2014				June 30, 2015				June 30, 2014				June 30, 2015				June 30, 2014
Revenues		$	645			$	955			$	3,774			$	4,954			$	0			$	0			$	4,419			$	5,909
Net income (loss)			(444	)			(31	)			116				200				0				-				(327	)			169

 

 

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/A for the year ended December 31, 2014. 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 MEDITE Cancer Diagnostics, Inc.

 

MEDITE Cancer Diagnostics, Inc. (the “Company”, “we”, or “us”), formerly CytoCore, Inc., is a medical technology company specializing in the development, engineering, manufacturing and marketing of premium medical devices and consumables for detection, risk assessment and diagnosis of cancer and related diseases. Depending upon the type of cancer, segments within the current target market of approximately $5.8 billion are growing at annual rates between 10 and 30%.

 

By acquiring MEDITE in 2014, the Company changed from just research operations to an operating company with 76 employees in four countries, a distribution network to about 70 countries worldwide, a well-known and established brand name, a wide range of selling products and the established infrastructure necessary for a company acting in the medical industry. Both company structures and cultures were successfully merged to one new company organization.

 

Several synergies were realized with this strategy, for example cost reduction of the former CytoCore research segment by about 50 %, complementary products in the cytology product segment which is now addressing all components from cell collection through cell processing to diagnostic tools like cancer markers and screening systems. Some of them are already selling and some are in a late stage of development expecting to sell within one or two years.

 

The cancer markers developed by the former CytoCore over the last three years are showing excellent results in internal studies but have not yet been tested in formal clinical trials. In our opinion, one of the tests based upon these biomarkers has the potential for displacing the current expensive Human Papilloma Virus (HPV) testing methods in both initial and follow up testing, resulting in less costs for the patient, laboratory and payer. The test may identify cancerous and precancerous cells regardless of the presence of HPV. The Company hopes to market the test globally outside the United States in 2015, and in the United States by 2017.

 

Another major business focus for 2015 is the Chinese market, which the Company entered in 2014. It is the fastest growing, and by 2016 management expect it will be the largest, market for the Company’s products. This is due to our Chinese distributor UNIC Medical who was successful in receiving the Chinese Food & Drug Administration (“CFDA”) approval for all MEDITE histrology laboratory devices. The UNIC sales team now can sell MEDITE products in China, and currently successfully is doing so. During the second quarter ended June 30, 2015, the Company trained 50 UNIC sales employees and representatives to sell MEDITE equipment. Also, together with UNIC, the Company is part of a government supported project to standardize the histology laboratory process there using MEDITE equipment and consumables for the processing part of the process, MEDITE immuno-assays, and the UNIC technology for digitalization and computer aided diagnostics utilizing the latest cloud technology.

 

Several other innovative product developments are in the marketing pipeline for this fiscal year of 2015. In the first quarter, the Company’s important German priority patent for the fully automated histology lab, a Lab-In-One unit, has been granted. This technology is demanded by the market, following the trend toward higher automation in the industry and has the ability change the competition in histology.

 

 

To sell the Company’s complete cytology product line set “SureThin” also in the US, a US Food and Drug Administration (“FDA”) application is required to be submitted and approved, which currently is under preparation and is expected to be submitted soon. The use with the currently highest market volume for products is in cervical cancer screening, but increasingly also in non-gynecology applications such as lung cancer screening.

 

The Company operates in one industry segment for cancer diagnostics instruments and consumables for histology and cytology laboratories.

 

Definition:	Histology - Cancer diagnostics based on the structures of cells in tissues
	Cytology - Cancer diagnostics based on the structures of individual cells

 

Cancers and precancerous conditions are defined in terms of structural abnormalities in cells. For this reason, cytology is widely used for the detection of such conditions, while histology is typically used for the confirmation, identification and characterization of the cellular abnormalities detected by cytology. Other diagnostics methods, such as marker-based assays, provide additional information that can supplement, but which cannot replace cytology and histology. The trend towards more personalized treatment of cancer increases the need for cytology, histology and assays for identifying and testing the best treatment alternatives. We believe that this segment will therefore be increasingly important for future development of strategies to fight the “cancer epidemic” (World Health Organization: World Cancer Report 2014) which expects approximately a 50 % increase in cancer cases worldwide within the next 20 years.

 

This segment sees a trend toward, and demand for, higher automation for more throughput in bigger laboratories, process standardization, digitalization of cell and tissue slides and computer aided diagnostic systems, while also looking for cost effective solutions. In the US, the Patient Protection and Affordable Care Act is a national example for the industry. More people have health insurance, and therefore can afford early cancer screening, while at the same time the payers for health care continue looking for cost reductions.

 

MEDITE acts as a one-stop-shop for histology (also known as anatomic pathology) laboratories either as part of a hospital, as part of a chain of laboratories or individually. It is one out of only four companies offering all equipment and consumables for these type of laboratories worldwide. The MEDITE Brand stands for innovative and high quality products – most equipment made in Germany – and competitive pricing.

 

For the cytology market, MEDITE offers a wide range of consumable products and equipment; in particular for liquid-based-cytology, which is an important tool in cancer screening and detection in the field of cervical, bladder, breast, lung and other cancer types. We also developed an innovative new type of easy to use standardized staining solutions, and a very innovative and effective early cancer detection marker-based assay. These new developments are cost effective solutions able to replace more expensive competitive products, and therefore are also becoming the first choice for the growing demand in emerging countries.

 

All of the Company’s operations during the reporting period were conducted and managed within this segment, with management teams reporting directly to our Chief Executive and Operating Officers. For information on revenues, profit or loss and total assets, among other financial data, attributable to our operations, see the unaudited condensed consolidated financial statements included herein.

 

Outlook

 

Due to promising new products and distributions contracts executed in the last two years, management believes the profitability and cash-flow of the business will grow and improve. However, significant on-going operating expenditures may be necessary to manufacture and market new and existing products to achieve the accelerated sales growth targets outlined in the Company’s business plan. To realize the planned growth potential, management will focus its efforts on 1.) Finishing and gaining approval for the products currently under development and 2.) Increase direct sales in the USA and continue to expand Chinese market sales by broadening the Company’s collaborations with the local distributor UNIC. We also will work on continuously optimizing manufacturing cost to increase our gross margin. Implementation of our plans will be contingent upon securing substantial additional debt and/or equity financing. If we are unable to obtain additional capital or generate profitable sales revenues, we may be required to curtail product development and other activities.

 

Currently, approximately 90 % of the Company’s sales are generated in Euro currency. During the previous year second quarter ended June 30, 2014, on average, $1.3702 was received for every Euro. During the first half of 2015, the average exchange rate of Euro for dollars dropped to $1.1170 which had an influence of 18.5% on the revenues. Therefore, the Company’s revenues translated from Euro into dollars may be down year over year if the exchange rate remains at that level or lower during the remainder of 2015. The Company is working to lessen the impact of the Euro’s decline versus the dollar by increasing the percentage of overall product sales in the United States and other countries such as China whose currency is not pegged to the Euro.

 

 

The Company believes the combination of MEDITE Enterprise, Inc. with CytoCore, Inc. will expedite the development and marketability of CytoCore’s cytology products which include collection devices, image analysis software, special stains and immuno-assays. Currently, 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 some primary positive factors assisting growth.

 

Results of Operations

 

The following discussion and analysis should be read in conjunction with the Company’s unaudited condensed 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/A for the year ended December 31, 2014 filed with the SEC on May 8, 2015.

 

The results of the Company for the six months ended June 30, 2015, include the results of the entire MEDITE Cancer Diagnostics, Inc. group (consolidated former CytoCore, Inc. with MEDITE Enterprise, Inc.) while the results for the six months periods ended June 30, 2014, reflect operations for MEDITE Enterprise, Inc. only from January 1 through April 4, 2014 and the combined companies of CytoCore, Inc and Medite Enterprise, Inc. for the period of April 5 through June 30, 2014.

 

Three months ended June 30, 2015 as compared to the three months ended June 30, 2014 (in thousand USD)

 

Revenue

 

Revenue for the three months ended June 30, 2015, was $2,132 as compared to $3,175 for the three months ended June 30, 2014. Due to the fact that approximately 90% of all sales are invoiced in Euro currency, the recent fluctuation of the USD/EURO exchange rate had a major impact of approximately $600 on the revenue decrease compared to last year’s exchange rate. On a comparable exchange rate, the revenue of the second quarter 2015 would have been approximately the same as the June 2014 quarter.

 

Costs of Revenue

 

Cost of revenues were $1,166, or 54.69% of the revenues for the three months ended June 30, 2015 as compared to $1,441 or 45.38% of the revenues for the three months ended June 30, 2014. More sales through international distributors as compared to higher margin direct sales is the major reason for the decreased gross margin.

 

Research and Development

 

Research and development expenses are an important part of our business to keep our existing products competitive, and to develop new innovative solutions with interesting market potential that will help us grow future revenues. These expenses include research work for cancer marker consumables and developing work, including engineering and industrial design, for histology and cytology laboratories worldwide. Major parts of these expenses are payroll-related costs for in-house scientific research, mechanical and electrical engineering, instrument related software development staff, prototype expenses and material purchased for R&D.

 

For the second quarter 2015, research and development expenses increased to $341 compared to $246 for the second quarter 2014. This increase of $95 or 38% is the result of the inclusion of the former CytoCore, Inc. and MEDITE Poland expenses for the entire period of second quarter 2015. We expect to continue to expend considerable effort and resources to continue to grow our product offerings.

 

Selling, General and Administrative

 

For the second quarter ended June 30, 2015, SG&A expenses were $600 as compared to $ 1,333 for the second quarter ended June 30, 2014. The second quarter ended June 30, 2014 compared to the second quarter ended June 30, 2015 expense reflects increased legal, accounting and other merger related expenses of approximately $200 expenses associated with the combination of Medite Enterprises and CytoCore Inc. as public companies. In addition, SG&A for the second quarter ended June 30, 2015 was credited for recovery of bad debts of $101 and correction of an inventory pricing error for $43.

 

Operating Income (Loss)

 

The operating loss of $6 for the second quarter of ended June 30, 2015 compared to an operating income of $116 for the second quarter of June 30, 2014 is due primarily to the decrease of gross profit and an increase of R&D expenses.

 

Interest Expense 

 

Interest expenses decreased by 28% to $54 in the six months ended June 30, 2015 compared to $75 for the six months ended June 30, 2014, due to the decreased use of lines of credit and repayment of term loans, both used for working capital financing of the European entities.

 

  

Net Income (Loss)

 

The net loss for the quarter ended June 30, 2015, totaled $73 as compared to net loss of $50 for the quarter ended June, 2014. As noted above the primary reason for the loss in the second quarter of 2015 was a decrease in gross profit and additional expenses in R&D.

 

Six months ended June 30, 2015 as compared to the six months ended June 30, 2014 (in thousand USD)

 

Revenue

 

Revenue for the six months ended June 30, 2015, was $4,419 as compared to $5,909 for the six months ended June 30, 2014. Due to the fact that approximately 90% of all sales are invoiced in Euro currency, the recent fluctuation of the USD/EURO exchange rate had a major impact of approximately $.75 million on the revenue decrease compared to last year’s exchange rate. On a comparable exchange rate, the revenue of the second quarter 2015 would have been increased by approximately 5-8%.

 

Costs of Revenue

 

Cost of revenues were $2,535, or 57% of the revenues for the six months ended June 30, 2015 as compared to $2.938 or 49% of the revenues for the six months ended June 30, 2014. More sales through international distributors as compared to higher margin direct sales is the major reason for the decreased gross margin.

 

Research and Development

 

Research and development expenses are an important part of our business to keep our existing products competitive, and to develop new innovative solutions with interesting market potential that will help us grow future revenues. These expenses include research work for cancer marker consumables and developing work, including engineering and industrial design, for histology and cytology laboratories worldwide. Major parts of these expenses are payroll-related costs for in-house scientific research, mechanical and electrical engineering, instrument related software development staff, prototype expenses and material purchased for R&D.

 

For the first half of 2015, research and development expenses increased to $603 compared to $445 for the first half 2014. This increase of $158 or 36% is the result of the inclusion of MEDITE Poland and the CytoCore expenses for the entire period of first half 2015. The Polish operations were not started until 3^rd quarter 2014 and CytoCore’s expenses for 2014 did not include expenses prior to April 3, 2014, the effective merger date. We expect to continue to expend considerable effort and resources to continue to grow our product offerings.

 

Selling, General and Administrative

 

For the six months ended June 30, 2015, SG&A expenses were $1,407 as compared to $ 1,962 for the first six months ended June 30, 2014. The first half of 2014 compared to the first half of 2015 reflects increased legal, accounting and other expenses associated with the combination of Medite Enterprises and CytoCore Inc. as public companies which became effective April 3, 2014.

 

Operating Income (Loss)

 

The operating loss of $191 for the first half of 2015 compares to an operating profit of $486 for the first half of 2014 is due primarily by the decrease in sales of $1,487 offset by the decrease in administrative expenses of $555 along with higher product gross margin and increased R&D expenses. The CytoCore, Inc. pre-merger expenses for the first quarter ended March 31, 2014 were not included in the company expenses ended June 30, 2014.

 

Interest Expense 

 

Interest expenses decreased by 26% to $111 in the six months ended June 30, 2015 compared to $150 for the first half ended June 30, 2014 due to the decreased use of lines of credit and repayment of term loans, both used for working capital financing of the European entities.

 

 

Net Income (Loss)

 

The net income (loss) for the six month ended June 30, 2015, totaled $(327) as compared to net income of $169 for the six month ended June 30, 2014 is due primary to a decrease in sales and the additional expenses in R&D. The CytoCore, Inc, pre-merger expenses for the first quarter ended March 31, 2014 were not included in the company expenses ended June 30, 2014.

 

Liquidity and Capital Resources

 

In the first quarter of 2015, the Company issued 240,625 shares of unregistered stock to qualified individuals under SEC Rule 144 at $1.60 for proceeds of $357, net of issuance costs of $28. Also, in the second quarter, the CEO of UNIC China, a foreign national purchased 711,250 shares of stock from the Company at $1.60 per share for net proceeds of $1,138 as part of a $3.5 million private placement. The Company expects he will complete his investment during 2015.

 

During 2014, in conjunction and subsequent to the April 4, 2014 merger of CytoCore, Inc. and Medite Enterprises, the Company has raised $1,979 million in funds for 1,237,125 common shares through various private placements and plans on raising additional equity through other private placements that have yet to close. The Company reduced debt by $1,006 net of currency during the first half of 2015.

 

Due to promising new products and distributions contracts executed in the last two years, management believes the profitability and cash flow of the business will grow and improve. However, significant on-going operating expenditures may be necessary to manufacture and market new and existing products to achieve the accelerated sales growth targets outlined in the Company’s business plan. To realize the planned growth potential management will focus its efforts on 1.) Finishing and gaining approval for the products currently under development and 2.) Increase direct sales in the USA and continue to expand Chinese market sales by broadening the Company’s collaborations with the local distributor UNIC. We also will work on continuously optimizing manufacturing cost to increase our gross margin. Implementation of our plans will be contingent upon securing substantial additional debt and/or equity financing. If we are unable to obtain additional capital or generate profitable sales revenues, we may be required to curtail product development and other activities. Approximately, $1.9 million of accrued liabilities represents unpaid wages and vacation benefits. We believe subject to employee approval at least 75% of this liability will be converted into equity. In summary, management believes current working capital is sufficient to fund current operations.

 

A part of the Company’s outstanding indebtedness under its master credit line #1 with Hannoversche Volksbank availability was reduced by Euro 500 ($543 as of June 30, 2015) effective July 1, 2015. The bank has agreed to work with the Company as we raise additional equity and maintain the current level of funding. Should the bank demand additional reductions in the line of credit, the Company is confident additional financing can be obtained through completion of the private placement still outstanding or obtain bank funding elsewhere at equivalent terms, or if necessary or raise the funds needed through operations.

 

The $950 short term advance provided financing before the planned investment of the CEO of UNIC, China, (see above) by Michaela Ott and Michael Ott during the first quarter ended March 31, 2015, which is no longer an obligation of the Company.

 

Off-Balance Sheet Arrangements

 

As of June 30, 2015, 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.

 

  

Part II. Other Information

 

Item 1. Legal Proceedings.

 

During the second quarter ended June 30, 2015, the Company settled a litigation case with D&D Technology, Inc. Union NJ, involving third party development costs with payment of $15,000 by MEDITE to D&D Technology. This amount had been previously expensed and recognized as an accrued liability in 2014.

 

On August 2013, the German local state court ruled the Company was not in breach of claims pursued by plantiff, Hologic Deutschland GmbH, Germany. However, the court ruled the Company must clearly differentiate their products in the German market from those offered by Hologic or be subject to court imposed penalties with a limit of Euro 250,000 ($277,360 as of June 30, 2015). Hologic has appealed the verdict and in addition the Company has appealed the provision of the verdict which applies to the possible penalty as described.

 

The Company’s former auditor L.J. Soldinger and Associates filed a claim against the Company in Illinois’ Lake County Superior Court. The case was later transferred to Federal District Court in Chicago, Illinois. The Company believes the claims are without merit and is adequately reserved for costs associated with the claim.

 

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

 

During the quarter ended June 30, 2015 the Company sold 711,250 shares of common stock to the President of UNIC Medical, a distributor-customer of the Company, at a per share price of $1.60, pursuant to Regulation S of the Securities Act of 1933. This person is a foreign national.

  

We issued the foregoing securities in reliance on the safe harbor and exemptions from registration provided by Regulation S of the Securities Act of 1933, as amended. No investor who participated in the offering was a U.S. citizen, and the offering was conducted by the officers and directors of the Company without the participation of any underwriters, and no commissions were paid to any person.

 

Item 3. Defaults upon Senior Securities.

 

As of the end of the second quarter, the remaining balance of approximately $21,000 on the note payable to Ventana Medical Systems, Inc. was in default. However, on February 23, 2015, the Company reached an agreement with Ventana Medical Systems, Inc. whereby both parties have agreed that Ventana Medical Systems, Inc. will accept $38,281 as payment in full for all outstanding principal and accrued interest. The $38,281 has been included in current portion of long-term debt on the consolidated balance sheet. As part of this agreement, Ventana Medical Systems, Inc. has agreed to convert $1.75 million stated value of Series D Preferred stock and all outstanding accrued dividends of $656,250 for 12,000 shares of the Company’s common stock. Prior to the execution of this agreement, the Company had failed to make principal and interest payments when due and is in breach of certain warranties and representations under the notes included above.

 

 

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 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 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

  

 

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.

 

	MEDITE Cancer Diagnostics, Inc.
Date:  August 13, 2015	/s/ Michaela Ott
	Michaela Ott
	Chief Executive Officer
Date: August 13, 2015	/s/ Robert F. McCullough, Jr.
	Robert F. McCullough, Jr.
	Chief Financial Officer