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, 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 November 13, 2015: 20,766,206
MEDITE Cancer Diagnostics, Inc.
Form 10-Q
For the Quarterly Period Ended
September 30, 2015
TABLE OF CONTENTS
PART I. — FINANCIAL INFORMATION
MEDITE CANCER DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars in thousands except shares and per
share amounts)
| |
September 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
| |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash | |
$ | 347 | | |
$ | 230 | |
Accounts receivable, net | |
| 1,302 | | |
| 1,991 | |
Inventories | |
| 4,161 | | |
| 3,415 | |
Prepaid expenses and other current assets | |
| 208 | | |
| 154 | |
Total current assets | |
| 6,018 | | |
| 5,790 | |
| |
| | | |
| | |
Property and equipment, net | |
| 2,016 | | |
| 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 | |
| 398 | | |
| 245 | |
Total assets | |
$ | 16,745 | | |
$ | 16,439 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Secured lines of credit and current portion of long-term debt | |
$ | 1,764 | | |
$ | 2,555 | |
Account payable and accrued expenses | |
| 4,025 | | |
| 4,134 | |
Advances – related parties | |
| 85 | | |
| 110 | |
Total current liabilities | |
| 5,874 | | |
| 6,799 | |
Long-term debt, net of current portion | |
| 981 | | |
| 1,209 | |
Total liabilities | |
| 6,855 | | |
| 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 September 30, 2015 and December 31, 2014, respectively (liquidation value of all classes of preferred stock $1,121 and $2,871 as of September 30, 2015 and December 31, 2014, respectively) | |
| 962 | | |
| 1,487 | |
Common stock, $0.001 par value; 3.5 billion shares
authorized, 20,766,206 and 19,427,331 issued and outstanding as of September 30, 2015 and December 31, 2014,
respectively | |
| 21 | | |
| 19 | |
Additional paid-in capital | |
| 8,343 | | |
| 5,763 | |
Treasury stock | |
| (327 | ) | |
| (327 | ) |
Accumulated other comprehensive loss | |
| (479 | ) | |
| (149 | ) |
Retained earnings | |
| 1,370 | | |
| 1,638 | |
Total stockholders’ equity | |
| 9,890 | | |
| 8,431 | |
| |
| | | |
| | |
Total liabilities and stockholders’ equity | |
$ | 16,745 | | |
$ | 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 September 30, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
(unaudited) | |
| |
| | |
| |
Net sales | |
$ | 2,662 | | |
$ | 2,785 | |
Cost of revenues | |
| 1,493 | | |
| 1,198 | |
Gross profit | |
| 1,169 | | |
| 1,587 | |
| |
| | | |
| | |
Operating expenses | |
| | | |
| | |
Depreciation and amortization expense | |
| 30 | | |
| 48 | |
Research and development | |
| 222 | | |
| 317 | |
Selling, general and administrative | |
| 785 | | |
| 1,260 | |
Total operating expenses | |
| 1,037 | | |
| 1,625 | |
Operating income (loss) | |
| 132 | | |
| (38 | ) |
| |
| | | |
| | |
Other expenses | |
| | | |
| | |
Interest expense | |
| 46 | | |
| 71 | |
Other expenses | |
| 11 | | |
| 2 | |
Total other expenses | |
| 57 | | |
| 73 | |
| |
| | | |
| | |
Income (loss) before income taxes | |
| 75 | | |
| (111 | ) |
| |
| | | |
| | |
Income tax expense (benefit) | |
| 16 | | |
| (8 | ) |
Net income (loss) | |
| 59 | | |
| (119 | ) |
| |
| | | |
| | |
Preferred dividend | |
| (23 | ) | |
| (18 | ) |
| |
| | | |
| | |
Net income (loss) applicable to common stockholders | |
$ | 36 | | |
$ | (137 | ) |
| |
| | | |
| | |
Condensed consolidated statements of comprehensive income
(loss) | |
| | | |
| | |
Net income (loss) | |
| 59 | | |
| (119 | ) |
Other comprehensive income (loss) | |
| | | |
| | |
Foreign currency translation adjustments | |
| (170 | ) | |
| 45 | |
| |
| | | |
| | |
Comprehensive (loss) | |
$ | (111 | ) | |
$ | (74 | ) |
| |
| | | |
| | |
Earnings (loss) per share | |
| | | |
| | |
Net income (loss) applicable to common stockholders | |
| 36 | | |
| (137 | ) |
Basic and diluted earnings (loss) per share | |
| - | | |
| (0.01 | ) |
Weighted average basic and diluted shares outstanding | |
| 20,484,936 | | |
| 19,345,231 | |
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)
| |
Nine Months Ended September 30, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
(unaudited) | |
| |
| | |
| |
Net sales | |
$ | 7,081 | | |
$ | 8,694 | |
Cost of revenues | |
| 4,028 | | |
| 4,456 | |
Gross profit | |
| 3,053 | | |
| 4,238 | |
| |
| | | |
| | |
Operating expenses | |
| | | |
| | |
Depreciation and amortization expense | |
| 95 | | |
| 126 | |
Research and development | |
| 825 | | |
| 762 | |
Selling, general and administrative | |
| 2,191 | | |
| 2,902 | |
| |
| | | |
| | |
Total operating expenses | |
| 3,111 | | |
| 3,790 | |
Operating income (loss) | |
| (58 | ) | |
| 448 | |
| |
| | | |
| | |
Other expenses | |
| | | |
| | |
Interest expense | |
| 157 | | |
| 221 | |
Other expenses | |
| 61 | | |
| 153 | |
Total other expenses | |
| 218 | | |
| 374 | |
| |
| | | |
| | |
Income (loss) before income taxes | |
| (276 | ) | |
| 74 | |
| |
| | | |
| | |
Income tax expense (benefit) | |
| (9 | ) | |
| 24 | |
Net income (loss) | |
| (267 | ) | |
| 50 | |
| |
| | | |
| | |
Preferred dividend | |
| (69 | ) | |
| (54 | ) |
| |
| | | |
| | |
Net (loss) applicable to common stockholders | |
$ | (336 | ) | |
$ | (4 | ) |
| |
| | | |
| | |
Condensed consolidated statements of comprehensive income
(loss) | |
| | | |
| | |
Net income (loss) | |
| (267 | ) | |
| 50 | |
Other comprehensive income (loss) | |
| | | |
| | |
Foreign currency translation adjustments | |
| (330 | ) | |
| 41 | |
| |
| | | |
| | |
Comprehensive income (loss) | |
$ | (597 | ) | |
$ | 91 | |
| |
| | | |
| | |
Earnings (loss) per share | |
| | | |
| | |
Net (loss) applicable to common stockholders | |
| (336 | ) | |
| (4 | ) |
Basic and diluted earnings (loss) per share | |
| (.01 | ) | |
| - | |
Weighted average basic and diluted shares outstanding | |
| 20,051,206 | | |
| 17,683,284 | |
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)
| |
Nine Months
Ended September 30, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
(unaudited) | |
Cash flows from operating activities: | |
| | | |
| | |
Net income (loss) | |
$ | (267 | ) | |
$ | 50 | |
Adjustments to reconcile net income (loss) to net cash used in operating activities | |
| | | |
| | |
Depreciation | |
| 95 | | |
| 126 | |
Non cash interest | |
| - | | |
| 4 | |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable, net | |
| 689 | | |
| 56 | |
Inventories | |
| (746 | ) | |
| (1,058 | ) |
Prepaid expenses and other current assets | |
| (54 | ) | |
| (150 | ) |
Accounts payable and accrued liabilities | |
| (109 | ) | |
| (391 | ) |
Net cash used in operating activities | |
| (392 | ) | |
| (1,363 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of equipment | |
| (19 | ) | |
| (391 | ) |
Increase (decrease) in other assets | |
| (154 | ) | |
| 1 | |
Net cash used in investing activities | |
| (173 | ) | |
| (390 | ) |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Net advances (repayments) on lines of credit and long-term debt | |
| (791 | ) | |
| 180 | |
Term note repayments | |
| (228 | ) | |
| (159 | ) |
Proceeds from sale of common stock, net issuance costs of $28 | |
| 2,056 | | |
| 1,842 | |
Net advances from (repayment to) related parties | |
| (25 | ) | |
| 9 | |
Net cash provided by financing activities | |
| 1,012 | | |
| 1,783 | |
| |
| | | |
| | |
Effect of exchange rates on cash | |
| (330 | ) | |
| 21 | |
Net increase in cash | |
| 117 | | |
| 140 | |
Cash at beginning of year | |
| 230 | | |
| 75 | |
| |
| | | |
| | |
Cash at end of the period | |
$ | 347 | | |
$ | 215 | |
| |
| | | |
| | |
Supplemental disclosure of cash flow information: | |
| | | |
| | |
Cash paid for interest | |
$ | 103 | | |
$ | 149 | |
Cash paid for income taxes | |
$ | 68 | | |
$ | 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 15,000,000 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., 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 71 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 September 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.
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 September 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 July 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 amendment 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.
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
remained to be issued because certain conditions had not been fulfilled in accordance with the agreement to complete the
exchange for 100% of the issued and outstanding stock of MEDITE Enterprise, Inc. The remaining 312,500 shares were issued in
October 2015. 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.
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.
The following is a summary of the components
of inventories (in thousands):
| |
September 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
| |
Raw materials | |
$ | 1,934 | | |
$ | 1,229 | |
Work in progress | |
| 225 | | |
| 33 | |
Finished Goods | |
| 2,002 | | |
| 2,153 | |
| |
| | | |
| | |
| |
$ | 4,161 | | |
$ | 3,415 | |
No amounts were reserved for obsolete inventory
as of September 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):
| |
September 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
| |
Land | |
$ | 215 | | |
$ | 233 | |
Buildings | |
| 1192 | | |
| 1,291 | |
Machinery and equipment | |
| 546 | | |
| 529 | |
Office furniture and equipment | |
| 295 | | |
| 265 | |
Vehicles | |
| 42 | | |
| 103 | |
Computer equipment | |
| 111 | | |
| 110 | |
Construction in progress | |
| 521 | | |
| 559 | |
Less: Accumulated depreciation | |
| (906 | ) | |
| (999 | ) |
| |
$ | 2,016 | | |
$ | 2,091 | |
Depreciation expense amounted to approximately
$95,000 and $126,000 for the nine months ended September 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):
| |
September 30, | | |
December 31, | |
| |
2015 | | |
2014 | |
| |
(unaudited) | | |
| |
Hannoversche Volksbank credit line #1 | |
$ | 1,169 | | |
$ | 1,880 | |
Hannoversche Volksbank credit line #2 | |
| 399 | | |
| 465 | |
Hannoversche Volksbank term loan #1 | |
| 62 | | |
| 135 | |
Hannoversche Volksbank term loan #2 | |
| 50 | | |
| 81 | |
Hannoversche Volksbank term loan #3 | |
| 203 | | |
| 270 | |
Ventana Medical Systems, Inc. Promissory Note | |
| 21 | | |
| 21 | |
Denture DZ Equity Partners Participation right | |
| 841 | | |
| 912 | |
| |
$ | 2,745 | | |
$ | 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 September 30, 2015). In January 2015, the
master credit line was reduced to Euro 1.6 million ($1.8 million as of September 30, 2015) and further reduced to the
original Euro 500,000 ($560,865 as of September 30, 2015) and subsequently increased to Euro 1.1 million ($1.2 million as of
September 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 ranged from 3.77 – 8.00% during the period ended
September 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 ($448,692 as of September 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 ranged from 3.77 – 8.00% during the period ended September
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 ($560,865 as of September 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 ($31,162 as of September 30, 2015). The term loan is guaranteed by Michaela Ott and Michael Ott, the former sole shareholders
of the Company and a mortgage on the property of the Company.
In June 2006, MEDITE GmbH, Burgdorf, entered
into a Euro 400,000 ($448,692 as of September 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
($24,928 as of September 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 ($448,692 as of September 30, 2015) term loan #3 with Hannoversche Volksbank with an interest rate of 4.7%
per annum. The term loan has a maturity of December 31, 2018, and requires quarterly principal repayments of Euro 13,890 ($15,581as
of September 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 September 30, 2015) in two tranches of Euro 750,000 each, ($841,298 as of September 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 floating
lines of credit and term loans with Hannoversche Volksbank by $1,019 net of currency fluctuations.
Note 6. |
Related Party Advances |
At September 30, 2015 and December 31, 2014,
the Company owed its then CFO and Chairman of the Board for prior advances of approximately $85,000 and $110,000 respectively.
During the nine months ended September 30, 2015,
the Company issued 1,338,875 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 $2,134,000, net of $81,000 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 third quarter ended September 30, 2015 the Company issued 1,086,250 shares of common stock at $1.60 for proceeds
of $600,000 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 September 30, 2015 and December 31, 2014 is as follows.
| |
September 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 September 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 Septebmer 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 September
30, 2015 and December 31, 2014 were $548,788 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 September
30, 2015 and December 31, 2014 were $160,038 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 September 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 September
30, 2015 and December 31, 2014 were $585,948 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 September 30, 2015 | |
| 143,308 | | |
$ | 2.64 | | |
| — | | |
| 6.46 | |
Note 9. |
Commitments and Contingencies |
The Company currently leases 12 vehicles for
sales and service employees, delivery and other purposes with expirations ranging from November 2015 through June 2018. The current
minimum monthly payment for these vehicle leases is approximately $5,463.
The Company has several operating 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 ($4,487 as of September 30, 2015) and PLN 6,240 ($1,660 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 $4,394. The Company’s Orlando facility has escalating
rents ranging from $2,416 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 $10,051.
The Company also leases IT Hardware and Software
for 3-D Design which require aggregate monthly lease payments of $1,645 through March 2018.
In 2014, the Company became a defendant
in 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 allegedly occurred in 2013 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 amount was paid during the third quarter.
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 has 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 nine month period ended September 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 in revenues by the significant
change of the currency exchange rate between USD and EURO since September 30, 2014 compared to September 30, 2015 is approximately
$1.1 million (USD/EURO exchange rate of 1.1151 vs. 1,3560). The following tables show the breakdown of the Company’s operations
and assets by region (in thousands):
| |
United States | | |
Germany | | |
Poland | | |
Total | |
| |
Sep. 30,
2015 | | |
Dec. 31,
2014 | | |
Sep.30, 2015 | | |
Dec. 31,
2014 | | |
Sep. 30, 2015 | | |
Dec. 31,
2014 | | |
Sep. 30, 2015 | | |
Dec. 31,
2014 | |
Assets | |
$ | 9,125 | | |
$ | 9,387 | | |
$ | 7,416 | | |
$ | 6,989 | | |
$ | 204 | | |
$ | 63 | | |
$ | 16,745 | | |
$ | 16,439 | |
Property & equipment, net | |
| 87 | | |
| 98 | | |
| 1,924 | | |
| 1,985 | | |
| 5 | | |
| 8 | | |
| 2,016 | | |
| 2,091 | |
Intangible assets | |
| 8,313 | | |
| 8,313 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 8,313 | | |
| 8,313 | |
| |
United States | | |
Germany | | |
Poland | | |
Total | |
| |
Sep. 30,
2015 | | |
Sep. 30, 2014 | | |
Sep. 30, 2015 | | |
Sep. 30, 2014 | | |
Sep. 30, 2015 | | |
Sep 30, 2014 | | |
Sep. 30, 2015 | | |
Sep. 30, 2014 | |
Revenues | |
$ | 928 | | |
$ | 1,321 | | |
$ | 6,114 | | |
$ | 7,373 | | |
$ | 39 | | |
$ | 0 | | |
$ | 7,081 | | |
$ | 8,694 | |
Net income (loss) | |
| (552 | ) | |
| (182 | ) | |
| 339 | | |
| 232 | | |
| (54 | ) | |
| - | | |
| (267 | ) | |
| 50 | |
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,
Inc. 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 2016, 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 expects 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 histology laboratory
devices. The UNIC sales team now can sell MEDITE products in China, and currently successfully is doing so. During the nine
months ended September 30, 2015, the Company trained 50 UNIC sales employees and representatives to sell MEDITE equipment.
During the third quarter MEDITE and UNIC attended a larger Chinese Cytology show and presented MEDITE’s cytology
product line. Also, together with UNIC, the Company is part of a government supported project to standardize the histology
laboratory process using MEDITE equipment and consumables for 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 realized or going to be realized before end of 2015. In the first quarter, the Company’s important
German priority patent for the fully automated histology lab, a Lab-In-One unit, was granted. This technology is demanded
by the market, following the trend toward higher automation in the industry and has the ability to 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 using data by a study made in
Germany and is expected to be submitted in 2016. 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 85 % of
the Company’s sales are generated in Euro currency. During the third quarter ended September 30, 2014,
on average, $1.3560 was received for every Euro. During the first nine months of 2015, the average exchange rate of Euro for
dollars dropped to $1.1151 which had an influence of 18% 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 nine
months ended September 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 nine months period ended September 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 September 30, 2014.
Three months ended September 30, 2015
as compared to the three months ended September 30, 2014 (in thousand USD)
Revenue
Revenue for the three months ended
September 30, 2015, was $2,662 as compared to $2,785 for the three months ended September 30, 2014. Due to the fact that
approximately 85% of all sales are invoiced in Euro currency, the recent fluctuation of the USD/EURO exchange rate had a
major impact of approximately $400 on the revenue decrease. On a comparable exchange rate, the revenue of the third quarter
2015 would have been increased by approximately 10%. Revenue of almost $0.5 million related to a public tender won in Mexico
will be invoiced in the fourth quarter while most of the manufacturing for the product was finished by the end of
the third quarter ended September 30, 2015.
Costs of Revenue
Cost of revenues were $1,493, or 56% of the
revenues for the three months ended September 30, 2015 as compared to $1,198 or 43% of the revenues for the three months ended
September 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 third quarter 2015, research and
development expenses decreased to $222 compared to $317 for the third quarter 2014. This was partly caused by the lower
USD/Euro exchange rate and by shifting engineering capacity from Germany to the lower cost country of Poland. We expect to
continue to expend considerable effort and resources to continue to grow our product offerings.
Selling, General and Administrative
For the third quarter ended September 30, 2015,
SG&A expenses were $785 as compared to $1,260 for the third quarter ended September 30, 2014. The decrease of $475 is partly
caused by the lower exchange rate in addition to the management’s ability to reduce administrative expenses with the former
CytoCore, Inc. business.
Operating Income (Loss)
The operating income of $132 for the third quarter
ended September 30, 2015 compared to an operating loss of $38 for the third quarter ended September 30, 2014 is due primarily
to the decrease of administrative and R&D expenses.
Interest Expense
Interest expenses decreased by 35% to $46 in
the third quarter ended September 30, 2015 compared to $71 for the third quarter ended September 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 for the third quarter ended September
30, 2015, increased by $178 and totaled $59 as compared to net loss of $119 for the third quarter ended September 30, 2014. As noted
above the primary reason for the profit in the third quarter 2015 was the management’s ability to decrease administrative
and R&D expenses more than the decrease of gross margin for the quarter.
Nine months ended September 30, 2015
as compared to the nine months ended September 30, 2014 (in thousand USD)
Revenue
Revenue for the nine months
ended September 30, 2015, was $7,081 as compared to $8,694 for the nine months ended September 30, 2014. Due to the fact
that approximately 85% of all sales are invoiced in Euro currency, the recent fluctuation of the USD/EURO exchange rate had
a major impact of approximately $1.1 million on the revenue decrease. Revenue of almost $0.5 million related to a public
tender won in Mexico will be invoiced in the fourth quarter while most of the manufacturing for the product was finished by
the end of the third quarter ended September 30, 2015.
Costs of Revenue
Cost of revenues were $4,028, or 57% of the
revenues for the nine months ended September 30, 2015 as compared to $4,456 or 51% of the revenues for the nine months ended September
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 nine months of 2015,
research and development expenses increased to $825 compared to $762 for the first nine months of 2014. This increase of
$63 or 8% is the result of the inclusion of MEDITE Poland and the CytoCore expenses for the entire period of the first nine
months of 2015. The Polish operations were not started until the end of 3rd 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 nine months ended September
30, 2015, SG&A expenses were $2,191 as compared to $ 2,902 for the first nine months ended September 30, 2014. The
decrease of $711 for the first nine months of 2014 compared to the first nine months of 2015 was mainly caused by
management’s ability to reduce administrative expenses in the former CytoCore, Inc. business.
Operating Income (Loss)
The operating loss of $58 for the first nine
months of 2015 compares to an operating profit of $448 for the first nine months of 2014 is due primarily by the decrease in the
gross profit of $1,185 partly offset by the decrease in administrative expenses of $711.
Interest Expense
Interest expenses decreased by 29% to $157 in
the nine months ended September 30, 2015 compared to $221 for the nine months ended Septbember 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 nine month ended
September 30, 2015, totaled $(267) as compared to net income of $50 for the nine months ended September 30, 2014 is due primary
to a decrease in gross profit.
Liquidity and Capital Resources
For the nine months ended September 30, 2015,
the Company issued a total of 1,338,875 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 $2,134,000, net of $81,000 of issuance
costs. During the third quarter ended September 30, 2015 the Company issued 375,000 shares of common stock at $1.60 for proceeds
of $600,000 to the President of UNIC Medical of China. UNIC Medical is the Company’s distributor for China and other Asian
countries.
The Company therefore increased its equity ratio
from 51.3% as of December 31, 2014 to 59.1% by the third quarter ended September 30, 2015. It also reduced total liability by $1,153 during the nine months ended September 30, 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 ($561 as of September 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.
Off-Balance Sheet Arrangements
As of September 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.
The appealed verdict between Hologic
Deutschland GmbH and the Company was decided by the court in October 2015 completely in favor of the Company. The
previously imposed possible penalties for the Company are no longer valid.
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
September 30, 2015 the Company sold 375,000 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 third 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
$21,000 has been included in current portion of long-term debt on the consolidated balance sheet and $17,281 has
been included in account payable and accrued expenses 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: November 13, 2015 |
/s/ Michaela Ott |
|
Michaela Ott |
|
Chief Executive Officer |
|
|
Date: November 13, 2015 |
/s/ Robert F. McCullough, Jr. |
|
Robert F. McCullough, Jr. |
|
Chief Financial Officer |
EXHIBIT 31.1
Certification
of Principal Executive Officer
Section 302
Certification
I,
Michaela Ott, certify that:
1. I
have reviewed this quarterly report on Form 10-Q for MEDITE CANCER DIAGNOSTICS, INC.;
2. Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
3. Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;
4. The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and the internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
(b) Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d) Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions):
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b) Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: |
November 13, 2015 |
|
/s/ Michaela Ott |
|
|
|
Michaela Ott, Chief Executive Officer
(Principal Executive Officer) |
EXHIBIT 31.2
Certification
of Principal Financial Officer
Section 302
Certification
I,
Robert F. McCullough, Jr., certify that:
1. I
have reviewed this quarterly report on Form 10-Q of MEDITE CANCER DIAGNOSTICS, INC;
2. Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report;
3. Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented
in this report;
4. The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and the internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
(b) Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d) Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions):
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which
are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b) Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date: |
November 13, 2015 |
|
/s/ Robert F. McCullough, Jr. |
|
|
|
Robert F. McCullough, Jr., Chief Financial Officer
(Principal Financial Officer) |
EXHIBIT 32.1
CERTIFICATIONS
PURSUANT TO
SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of MEDITE CANCER DIAGNOSTICS,
INC. (the “Company”) on Form 10-Q for the quarter ended September 30, 2015, as filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, Michaela Ott, as Chief Executive Officer of the Company, certify,
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
|
1. |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
2. |
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
|
|
|
|
By: |
/s/ Michaela Ott |
Dated: |
November 13, 2015 |
|
Michaela Ott |
|
|
Title: |
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
EXHIBIT 32.2
CERTIFICATIONS
PURSUANT TO
SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of MEDITE CANCER DIAGNOSTICS,
INC. (the “Company”) on Form 10-Q for the quarter ended September 30, 2015, as filed with the Securities and Exchange
Commission on the date hereof (the “Report”), I, Robert F. McCullough, Jr,, as Chief Financial Officer of the Company,
certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
|
1. |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
2. |
The information contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company. |
|
|
|
|
By: |
/s/ Robert F. McCullough, Jr. |
Dated: |
November 13, 2015 |
|
Robert F. McCullough, Jr. |
|
|
Title: |
Chief Financial Officer
(Principal Financial Officer)
|
Medite Cancer Diagnostics (CE) (USOTC:MDIT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medite Cancer Diagnostics (CE) (USOTC:MDIT)
Historical Stock Chart
From Sep 2023 to Sep 2024