ITEM
1.
|
FINANCIAL
STATEMENTS
|
VYCOR
MEDICAL, INC.
Consolidated Balance Sheets
(Unaudited)
|
|
September
30, 2018
|
|
|
December
31, 2017
|
|
ASSETS
|
|
|
|
|
|
|
Current Assets
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
90,130
|
|
|
$
|
206,213
|
|
Trade accounts receivable
|
|
|
245,154
|
|
|
|
110,422
|
|
Inventory
|
|
|
218,309
|
|
|
|
213,883
|
|
Prepaid
expenses and other current assets
|
|
|
99,903
|
|
|
|
77,990
|
|
Total
Current Assets
|
|
|
653,496
|
|
|
|
608,508
|
|
|
|
|
|
|
|
|
|
|
Fixed assets,
net
|
|
|
445,454
|
|
|
|
489,170
|
|
|
|
|
|
|
|
|
|
|
Intangible and Other assets:
|
|
|
|
|
|
|
|
|
Trademarks
|
|
|
251,157
|
|
|
|
251,157
|
|
Patents, net of
accumulated amortization
|
|
|
46,743
|
|
|
|
81,064
|
|
Website, net of
accumulated amortization
|
|
|
6,962
|
|
|
|
10,389
|
|
Security
deposits
|
|
|
6,000
|
|
|
|
9,169
|
|
Total
Intangible and Other assets
|
|
|
310,862
|
|
|
|
351,779
|
|
TOTAL ASSETS
|
|
$
|
1,409,812
|
|
|
$
|
1,449,457
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
Current Liabilities
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
95,744
|
|
|
$
|
141,319
|
|
Accrued interest:
Other
|
|
|
220,666
|
|
|
|
184,765
|
|
Accrued interest:
Related party
|
|
|
19,410
|
|
|
|
12,840
|
|
Accrued liabilities
- Other
|
|
|
305,273
|
|
|
|
161,328
|
|
Accrued liabilities
- Related Party
|
|
|
648,740
|
|
|
|
549,370
|
|
Notes payable: Other
|
|
|
346,866
|
|
|
|
318,393
|
|
Notes
payable: Related Party
|
|
|
193,000
|
|
|
|
-
|
|
Total Current
Liabilities
|
|
|
1,829,699
|
|
|
|
1,368,015
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
|
|
|
|
|
|
|
Preferred stock,
$0.0001 par value, 10,000,000 shares authorized, 270,306 and 270,306 issued and outstanding as at September 30, 2018 and December
31, 2017 respectively
|
|
|
27
|
|
|
|
27
|
|
Common Stock, $0.0001
par value, 55,000,000, 22,708,314 and 19,925,322 shares issued and 22,604,980 and 19,821,988 outstanding at September 30,
2018 and December 31, 2017 respectively
|
|
|
2,271
|
|
|
|
1,993
|
|
Additional Paid-in
Capital
|
|
|
27,638,421
|
|
|
|
26,921,574
|
|
Treasury Stock (103,334
shares of Common Stock as at September 30, 2018 and December 31, 2017 respectively, at cost)
|
|
|
(1,033
|
)
|
|
|
(1,033
|
)
|
Accumulated Deficit
|
|
|
(28,187,729
|
)
|
|
|
(26,965,960
|
)
|
Accumulated
Other Comprehensive Income (Loss)
|
|
|
128,156
|
|
|
|
124,841
|
|
Total
Stockholders’ Equity (Deficiency)
|
|
|
(419,887
|
)
|
|
|
81,442
|
|
TOTAL LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
|
|
$
|
1,409,812
|
|
|
$
|
1,449,457
|
|
See
accompanying notes to financial statements
VYCOR
MEDICAL, INC.
Consolidated Statements of Comprehensive Loss
(Unaudited)
|
|
For
the three months ended September 30,
|
|
|
For
the nine months ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
456,213
|
|
|
$
|
379,073
|
|
|
$
|
1,082,979
|
|
|
$
|
1,115,155
|
|
Cost
of Revenues Sold
|
|
|
46,800
|
|
|
|
55,332
|
|
|
|
123,130
|
|
|
|
142,753
|
|
Gross Profit
|
|
|
409,413
|
|
|
|
323,741
|
|
|
|
959,849
|
|
|
|
972,402
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
Amortization
|
|
|
42,994
|
|
|
|
72,734
|
|
|
|
128,326
|
|
|
|
211,369
|
|
General
and administrative
|
|
|
499,143
|
|
|
|
546,615
|
|
|
|
1,684,445
|
|
|
|
1,710,244
|
|
Total
Operating expenses
|
|
|
542,137
|
|
|
|
619,349
|
|
|
|
1,812,771
|
|
|
|
1,921,613
|
|
Operating loss
|
|
|
(132,724
|
)
|
|
|
(295,608
|
)
|
|
|
(852,922
|
)
|
|
|
(949,211
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense:
Other
|
|
|
(12,280
|
)
|
|
|
(11,360
|
)
|
|
|
(36,505
|
)
|
|
|
(32,217
|
)
|
Interest expense:
Related Party
|
|
|
(5,924
|
)
|
|
|
-
|
|
|
|
(6,570
|
)
|
|
|
(679
|
)
|
Warrant Issuance
Expense
|
|
|
-
|
|
|
|
(120,788
|
)
|
|
|
-
|
|
|
|
(120,788
|
)
|
Loss
on foreign currency exchange
|
|
|
(1,251
|
)
|
|
|
(646
|
)
|
|
|
(1,402
|
)
|
|
|
986
|
|
Total
Other Income (expense)
|
|
|
(19,455
|
)
|
|
|
(132,794
|
)
|
|
|
(44,477
|
)
|
|
|
(152,698
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Before Credit
for Income Taxes
|
|
|
(152,179
|
)
|
|
|
(428,402
|
)
|
|
|
(897,399
|
)
|
|
|
(1,101,909
|
)
|
Credit
for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Net Loss
|
|
|
(152,179
|
)
|
|
|
(428,402
|
)
|
|
|
(897,399
|
)
|
|
|
(1,101,909
|
)
|
Preferred
stock dividends
|
|
|
(162,185
|
)
|
|
|
(162,185
|
)
|
|
|
(324,370
|
)
|
|
|
(324,370
|
)
|
Net
Loss available to common stockholders
|
|
|
(314,364
|
)
|
|
|
(590,587
|
)
|
|
|
(1,221,769
|
)
|
|
|
(1,426,279
|
)
|
Other comprehensive
income (loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
Currency Translation Adjustment
|
|
|
810
|
|
|
|
(1,728
|
)
|
|
|
3,315
|
|
|
|
(4,687
|
)
|
Comprehensive
loss available to common stockholders
|
|
$
|
(313,554
|
)
|
|
$
|
(592,315
|
)
|
|
$
|
(1,218,454
|
)
|
|
$
|
(1,430,966
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss Per Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$
|
(0.01
|
)
|
|
$
|
(0.03
|
)
|
|
$
|
(0.06
|
)
|
|
$
|
(0.08
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
Number of Shares Outstanding – Basic and Diluted
|
|
|
22,221,266
|
|
|
|
19,715,156
|
|
|
|
21,258,184
|
|
|
|
17,895,269
|
|
See
accompanying notes to financial statements
VYCOR
MEDICAL, INC.
Consolidated Statement of Cash Flows
(Unaudited)
|
|
For
the nine months ended
|
|
|
|
September
30,
|
|
|
|
2018
|
|
|
2017
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(897,399
|
)
|
|
$
|
(1,101,909
|
)
|
Adjustments to reconcile
net loss to cash used in operating activities:
|
|
|
|
|
|
|
|
|
Amortization of
intangible assets
|
|
|
37,748
|
|
|
|
129,176
|
|
Depreciation of
fixed assets
|
|
|
98,455
|
|
|
|
93,467
|
|
Inventory provision
|
|
|
3,139
|
|
|
|
2,544
|
|
Stock based compensation
|
|
|
492,125
|
|
|
|
309,805
|
|
Accrued liabilities
– Related Party
|
|
|
-
|
|
|
|
112,500
|
|
Warrant Issuance
Expense
|
|
|
-
|
|
|
|
120,788
|
|
Loss on foreign
exchange
|
|
|
-
|
|
|
|
988
|
|
Changes in assets
and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(134,732
|
)
|
|
|
(89,348
|
)
|
Inventory
|
|
|
(7,565
|
)
|
|
|
(10,678
|
)
|
Prepaid expenses
|
|
|
(21,913
|
)
|
|
|
91,337
|
|
Security Deposits
|
|
|
3,169
|
|
|
|
33,255
|
|
Accrued interest
- Related Party
|
|
|
6,570
|
|
|
|
680
|
|
Accrued interest
- Other
|
|
|
35,901
|
|
|
|
35,902
|
|
Accounts payable
|
|
|
(45,575
|
)
|
|
|
(75,794
|
)
|
Accrued
liabilities - Other
|
|
|
143,945
|
|
|
|
(3,925
|
)
|
Cash used in
operating activities
|
|
|
(286,132
|
)
|
|
|
(351,212
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchase
of fixed assets
|
|
|
(56,604
|
)
|
|
|
(160,324
|
)
|
Cash used in
investing activities
|
|
|
(56,604
|
)
|
|
|
(160,324
|
)
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from issuance
of common stock, net
|
|
|
-
|
|
|
|
842,207
|
|
Proceeds from Notes
Payable - Related Party
|
|
|
193,000
|
|
|
|
-
|
|
Proceeds
net of repayments Notes Payable - Other
|
|
|
28,473
|
|
|
|
(65,038
|
)
|
Cash provided
by financing activities
|
|
|
221,473
|
|
|
|
777,169
|
|
Effect of exchange rate changes on cash
|
|
|
5,180
|
|
|
|
(7,475
|
)
|
Net increase (decrease) in cash
|
|
|
(116,083
|
)
|
|
|
258,158
|
|
Cash at beginning of period
|
|
|
206,213
|
|
|
|
56,859
|
|
Cash at end of period
|
|
$
|
90,130
|
|
|
$
|
315,017
|
|
|
|
|
|
|
|
|
|
|
Supplemental Disclosures of Cash Flow
information:
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$
|
0
|
|
|
$
|
0
|
|
Cash
paid for income tax
|
|
$
|
0
|
|
|
$
|
0
|
|
Non-Cash Transactions:
|
|
|
|
|
|
|
|
|
Common stock
issued upon conversion of debt
|
|
$
|
0
|
|
|
$
|
248,000
|
|
Common stock
issued in respect of funds held in escrow
|
|
$
|
0
|
|
|
$
|
101,000
|
|
Common stock
issued to related party for payment of accrued liabilities
|
|
$
|
225,000
|
|
|
$
|
0
|
|
See
Accompanying Notes to Financial Statements
VYCOR
MEDICAL, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2018
(Unaudited)
The
accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States (“GAAP”) for interim financial information and with the instructions to Form 10-Q and
Article 8 of Regulation S-X of the Securities Exchange Commission. In accordance with those rules and regulations certain information
and footnote disclosures normally included in consolidated financial statements have been omitted pursuant to such rules and regulations.
The consolidated balance sheet as of December 31, 2017 derives from the audited financial statements at that date, but does not
include all the information and footnotes required by GAAP. These financial statements should be read in conjunction with the
audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December
31, 2017.
The
unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2018 and 2017, in the
opinion of management, include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation
of the Company’s financial condition and results of operations. The results of operations for the three and nine months
ended September 30, 2018 and 2017 are not necessarily indicative of the results to be expected for any other interim period or
for the entire year. Certain prior period amounts have been reclassified to conform to the current presentation.
Ability
to continue as a Going Concern
The
accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going
concern. The Company has incurred losses since its inception, including a net loss of $897,399 for the nine months ended September
30, 2018 and has not generated cash flows from operations. As of September 30, 2018 the Company had a working capital deficiency
of $315,053, excluding related party liabilities of $861,150. As a result, these conditions, among others, raise substantial doubt
regarding our ability to continue as a going concern. The financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result
from the outcome of this uncertainty.
The Company is executing on a plan to achieve
a reduction in cash operating losses for both the Vycor Medical and NovaVision divisions, as further described in ITEM 2.
However,
the Company believes it may not have sufficient cash to meet its various cash needs through November 30, 2019 unless the Company
is able to obtain additional cash from the issuance of debt or equity securities. Included within the working capital deficiency
above is a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”), together with accrued interest
of $220,666, which has a maturity date of December 31, 2018, having been extended on a number of occasions from its initial due
date of June 11, 2011. The Company intends to seek an extension to the note, although it is not known whether the note will be
extended or the terms of any extension. Fountainhead, the Company’s largest shareholder, is currently providing working
capital funding to the Company on an as-needed basis, although there is no guarantee that this will continue to be the case. The
Company may consider seeking additional equity or debt funding, although there is no assurance that this would be available on
acceptable terms or at all. If adequate funds are not available, the Company may have to delay or curtail development or commercialization
of products, or cease some of its operations.
2.
|
SIGNIFICANT
ACCOUNTING POLICIES
|
Principles
of Consolidation
The
unaudited consolidated financial statements include the accounts of Vycor Medical, Inc., and its wholly-owned subsidiaries, NovaVision,
Inc. (a Delaware corporation), NovaVision GmbH (a German corporation) and Sight Science Limited (a UK corporation), both wholly
owned subsidiaries of NovaVision, Inc. The Company is headquartered in Boca Raton, FL. All material inter-company accounts, transactions,
and profits have been eliminated in consolidation.
Recent
Accounting Pronouncements
From
time to time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies
that may have an impact on the Company’s accounting and reporting. The Company believes that such recently issued accounting
pronouncements and other authoritative guidance for which the effective date is in the future will not have an impact on its accounting
or reporting or that such impact will not be material to its financial position, results of operations and cash flows when implemented.
Net
Loss Per Share
Basic
net loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding during the period.
Diluted net loss per share is computed giving effect to all dilutive potential common shares that were outstanding during the
period. Dilutive potential common shares consist of incremental shares issuable upon exercise of stock options and warrants and
conversion of preferred stock and convertible debt. Such potentially dilutive shares are excluded when the effect would be to
reduce a net loss per share. No dilution adjustment has been made to the weighted average outstanding common shares in the periods
presented because the assumed exercise of outstanding options and warrants and the conversion of preferred stock and debt would
be anti-dilutive.
The
following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per
share:
|
|
September
30, 2018
|
|
|
September
30, 2017
|
|
Stock options outstanding
|
|
|
1,380,000
|
|
|
|
725,557
|
|
Warrants to purchase common stock
|
|
|
3,717,826
|
|
|
|
7,001,388
|
|
Debentures convertible into common stock
|
|
|
2,479,364
|
|
|
|
262,593
|
|
Preferred shares convertible into common
stock
|
|
|
1,272,052
|
|
|
|
1,272,052
|
|
Directors Deferred
Compensation Plan
|
|
|
685,107
|
|
|
|
447,689
|
|
Total
|
|
|
9,534,349
|
|
|
|
9,709,279
|
|
Related
Parties Notes Payable
Related
Party Notes Payable consists of:
|
|
September
30, 2018
|
|
|
December
31, 2017
|
|
In
the period the Company issued promissory notes to Fountainhead Capital Management Limited and Peter Zachariou for $193,000.
The notes bear interest at 10% per annum and are payable on the earlier of one year or five days following the delivery of
written demand for payment by the Payee.
|
|
$
|
193,000
|
|
|
$
|
-
|
|
Total Related
Party Notes Payable
|
|
$
|
193,000
|
|
|
$
|
-
|
|
Other
Notes Payable
Other
Notes Payable consists of:
|
|
September
30, 2018
|
|
|
December
31, 2017
|
|
On March 25, 2011 the Company
issued a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”). The term note bears interest
at 16% per annum and was due June 25, 2011, and has been extended on a number of occasions. On the note’s most recent
due date, the note was amended and extended to December 31, 2018. See further note below.
|
|
$
|
300,000
|
|
|
$
|
300,000
|
|
Insurance
policy finance agreements.
|
|
|
46,866
|
|
|
|
18,393
|
|
Total Notes Payable:
|
|
$
|
346,866
|
|
|
$
|
318,393
|
|
On
January 24, 2018 the Company entered into an amendment agreement (the “Amendment”) with EuroAmerican Investments (“EuroAmerican”)
regarding its $300,000 loan note (the “Note”). Under the Amendment, the Note was extended until December 31, 2018
and the conversion terms of the Note reduced to $0.21, the same as the offering price of the 2018 Offering. Conversion of the
Note and accrued interest would result in the issuance of 2,479,364 shares of Common Stock as of September 30, 2018. Notwithstanding,
EuroAmerican agreed that the Note could not be converted without first offering the Company the right to redeem the Note at principal
and accrued interest, and secondly Fountainhead the right to purchase the Note, which cannot be converted prior to such offer
and the failure of the Company and Fountainhead to exercise such option in accordance with the amendment terms. In addition, the
Company agreed to issue warrants to purchase 2,308,405 shares of Common Stock at $0.27, the same terms as the 2018 Offering, exercisable
for three years from January 1, 2018, if and when the conversion option is exercised. The amendment was recognized as a modification,
based on the guidance in ASC 470-50.
The
Company routinely finances all their insurance policies through a third party finance company which requires a down payment and
subsequent monthly payments, the time periods vary from 10 months to 12 equal monthly payments.
4.
|
SEGMENT
REPORTING, GEOGRAPHICAL INFORMATION
|
(a)
Business segments
The
Company operates in two business segments: Vycor Medical, which focuses on devices for neurosurgery; and NovaVision, which focuses
on neuro stimulation therapies and diagnostic devices for the treatment and screening of vision field loss and which includes
Sight Science. Set out below are the revenues, gross profits and total assets for each segment
|
|
Three
Months Ended September 30,
|
|
|
Nine
Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor
Medical
|
|
$
|
399,450
|
|
|
$
|
326,843
|
|
|
$
|
930,553
|
|
|
$
|
949,053
|
|
NovaVision
|
|
$
|
56,763
|
|
|
$
|
52,230
|
|
|
$
|
152,426
|
|
|
$
|
166,102
|
|
|
|
$
|
456,213
|
|
|
$
|
379,073
|
|
|
$
|
1,082,979
|
|
|
$
|
1,115,155
|
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
357,674
|
|
|
$
|
277,324
|
|
|
$
|
821,240
|
|
|
$
|
824,176
|
|
NovaVision
|
|
$
|
51,739
|
|
|
$
|
46,417
|
|
|
$
|
138,609
|
|
|
$
|
148,226
|
|
|
|
$
|
409,413
|
|
|
$
|
323,741
|
|
|
$
|
959,849
|
|
|
$
|
972,402
|
|
|
|
September
30,
2018
|
|
|
December
31,
2017
|
|
Total Assets:
|
|
|
|
|
|
|
|
|
Vycor
Medical
|
|
$
|
1,005,504
|
|
|
$
|
977,145
|
|
NovaVision
|
|
|
404,308
|
|
|
|
472,312
|
|
Total
Assets
|
|
$
|
1,409,812
|
|
|
$
|
1,449,457
|
|
(b)
Geographic information
The
Company operates in two geographic segments, the United States and Europe. Set out below are the revenues, gross profits and total
assets for each segment.
|
|
Three
Months Ended September 30,
|
|
|
Nine
Months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
425,800
|
|
|
$
|
352,109
|
|
|
$
|
1,002,923
|
|
|
$
|
1,033,087
|
|
Europe
|
|
$
|
30,413
|
|
|
$
|
26,964
|
|
|
$
|
80,056
|
|
|
$
|
82,068
|
|
|
|
$
|
456,213
|
|
|
$
|
379,073
|
|
|
$
|
1,082,979
|
|
|
$
|
1,115,155
|
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
382,006
|
|
|
$
|
300,687
|
|
|
$
|
889,190
|
|
|
$
|
899,298
|
|
Europe
|
|
$
|
27,407
|
|
|
$
|
23,054
|
|
|
$
|
70,659
|
|
|
$
|
73,104
|
|
|
|
$
|
409,413
|
|
|
$
|
323,741
|
|
|
$
|
959,849
|
|
|
$
|
972,402
|
|
|
|
September
30,
2018
|
|
|
December
31,
2017
|
|
Total Assets:
|
|
|
|
|
|
|
|
|
United
States
|
|
$
|
1,234,469
|
|
|
$
|
1,263,197
|
|
Europe
|
|
|
175,343
|
|
|
|
186,260
|
|
Total Assets
|
|
$
|
1,409,812
|
|
|
$
|
1,449,457
|
|
Common
Stock and Stock Grants
During
January to September 2018, the Company granted 174,580 shares of Common Stock (valued at $63,000) to non-employee Directors. Under
the terms of the Directors Deferred Compensation Plan, the receipt of these shares is deferred until the January 15
th
following the termination of their services as a director. As of September 30, 2018 these shares have yet to be issued.
During
January to September 2018, the Company issued 1,669,056 shares of Common Stock to Fountainhead for fees of $583,500 of which $225,000
was accrued at December 31, 2017 in accordance with the terms of a Consulting Agreement.
On
April 20, 2018, the Company issued an aggregate of 1,113,936 shares of Company Common Stock on the cashless exercise of an aggregate
of Warrants to purchase 3,111,560 shares of Common Stock
Warrants
and Options
The
details of the outstanding warrants and options are as follows:
STOCK
WARRANTS:
|
|
|
|
|
Weighted
average
|
|
|
|
Number
of shares
|
|
|
exercise
price per share
|
|
Outstanding at December 31, 2017
|
|
|
6,929,386
|
|
|
$
|
0.31
|
|
Granted
|
|
|
-
|
|
|
|
-
|
|
Exercised
|
|
|
(3,111,560
|
)
|
|
|
0.28
|
|
Cancelled or
expired
|
|
|
(100,000
|
)
|
|
|
2.56
|
|
Outstanding at September 30, 2018
|
|
|
3,717,826
|
|
|
$
|
0.27
|
|
STOCK
OPTIONS:
|
|
|
|
|
Weighted
average
|
|
|
|
Number
of shares
|
|
|
exercise
price per share
|
|
Outstanding at December 31, 2017
|
|
|
725,557
|
|
|
$
|
0.95
|
|
Granted
|
|
|
680,000
|
|
|
|
0.28
|
|
Exercised
|
|
|
-
|
|
|
|
-
|
|
Cancelled or
expired
|
|
|
(25,557
|
)
|
|
|
5.97
|
|
Outstanding at September 30, 2018
|
|
|
1,380,000
|
|
|
$
|
0.53
|
|
In
March 2017 options to purchase 660,000 shares of Common Stock were granted to Fountainhead under the terms of a Consulting Agreement,
subject to performance vesting milestones; these milestones were achieved and the options fully vested on June 30, 2018. In March
2018 options to purchase 660,000 shares of Common Stock were granted to Fountainhead under the terms of the Consulting Agreement.
These options will vest on April 1, 2019 subject to the achievement of certain milestones by March 31, 2019. These options are
not included in the above table until such a time as they vest.
As
of September 30, 2018, the weighted-average remaining contractual life of outstanding warrants and options is 1.36 and 1.61 years,
respectively.
6.
|
SHARE-BASED
COMPENSATION
|
Stock
Option Plan
Under
ASC Topic 718, the Company estimates the fair value of option awards on the date of grant using an option pricing model. The grant
date fair value is recognized over the option-vesting period, the period during which an employee is required to provide service
in exchange for the award. No compensation cost is recognized for equity instruments for which employees do not render the requisite
service. Under these standards, compensation cost for employee cost for employee stock-based awards is based on the estimated
grant-date fair value and recognized over the vesting period of the applicable award on a straight-line basis.
For
the nine months ended September 30, 2018 and 2017, the Company recognized share-based compensation of $4,871 and $1,609, respectively,
for employee stock options.
Stock
appreciation rights may be granted either on a stand-alone basis or in conjunction with all or part of any other stock options
granted under the plan. As of September 30, 2018 there were no awards of any stock appreciation rights.
Non-Employee
Stock Compensation
The
Company from time to time issues common stock, stock options or common stock warrants to acquire services or goods from non-employees.
Common stock, stock options and common stock warrants issued to other than employees or directors are recorded on the basis of
their fair value, which is measured as of the “measurement date” using an option pricing model. The “measurement
date” for options and warrants related to contracts that have substantial disincentives to non-performance is the date of
the contract, and for all other contracts is the vesting date. Expense related to the options and warrants is recognized on a
straight-line basis over the shorter of the period over which services are to be received or the life of the option or warrant.
Aggregate
stock-based compensation for stock and warrants granted to non-employees for the nine months ended September 30, 2018 and 2017
was $487,254 and $420,696. The expense related to stock not issued during the periods ended September 30, 2018 and 2017 comprise:
$63,000, respectively for both periods, related to stock granted but not issued to directors under the Directors Deferred Compensation
Plan; and $86,754 related to the issuance of 660,000 options in the nine months ended September 30
,
2018 discussed
below. As of September 30, 2018, there was $0 of total unrecognized compensation costs related to warrant and stock awards and
non-vested options.
During
the nine months ended September 30, 2018 and 2017, options with a value of $216,582 and $86,754, respectively, were granted to
Fountainhead with performance vesting conditions, (see Note 8). The performance conditions of the options granted during 2017
have now been met and these options became fully vested in June 2018 and recognized as stock compensation during the period. The
value of the 2018 options will not be recognized as share-based compensation unless or until the Company concludes that it is
probable the performance conditions will be achieved.
Stock-based
Compensation Valuation Methodology
Stock-based
compensation resulting from the issuance of Common Stock is calculated by reference to the valuation of the Stock on the date
of issuance, the expense being recognized as the compensation is earned. Stock-based compensation expenses related to employee
options and warrants granted to non-employees are recognized as the stock options and warrants are earned. The fair value of the
stock options or warrants granted is estimated at the grant date, using the Black-Scholes option pricing model, and the expense
is recognized on a straight-line basis over the shorter of the period over which services are to be received or the life of the
option or warrant. The grant date fair value of employee share options and similar instruments is estimated using the Black-Scholes
option pricing model on the basis of the fair value of the underlying common stock on the measurement date, adjusted for the unique
characteristics of those equity instruments, using the assumptions noted in the table below. Expected volatility is based on the
historical volatility of a peer group of publicly traded companies. The expected term of options and warrants was based upon the
expected life of the option or warrant, and the risk-free rate is based on the U.S. Treasury Constant Maturity rate.
The
following assumptions were used in calculations of the Black-Scholes option pricing model for the nine months ended September
30, 2018 and 2017:
|
|
Nine
months Ended September 30,
|
|
|
|
2018
|
|
|
2017
|
|
Risk-free
interest rates
|
|
|
1.72-2.41
|
%
|
|
|
1.50
|
%
|
Expected
life
|
|
|
1.5-4
years
|
|
|
|
1.5
years
|
|
Expected
dividends
|
|
|
0
|
%
|
|
|
0
|
%
|
Expected
volatility
|
|
|
102-107
|
%
|
|
|
104
|
%
|
Vycor
Common Stock fair value
|
|
$
|
0.20-0.49
|
|
|
$
|
0.20
|
|
7.
|
COMMITMENTS
AND CONTINGENCIES
|
Lease
The
Company leases office space located at 951 Broken Sound Parkway, Suite 320, Boca Raton, FL 33487 from WPT Land 2 L.P., for a gross
rent of approximately $5,700 plus sales tax per month. The lease terminates September 30, 2020. The Company’s subsidiary
in Germany occupies premises on a short-term lease agreement. Rent expense for the nine months ended September 30, 2018 and 2017
was $74,784 and $134,229 respectively.
Potential
German tax liability
In
June 2012 the Company’s German subsidiary received a preliminary assessment for Magdeburg City trade tax of approximately
€75,000 (approximately $85,000). This assessment is for the 2010 fiscal year and relates to the Company’s acquisition
of the assets of the former NovaVision, Inc. An initial assessment for corporate tax for the same period has been preliminarily
reduced to zero. The Company has not accepted this trade tax assessment and is in discussion with the relevant tax authorities
with a view to its reduction. The tax authorities have agreed to suspend the assessment pending the outcome of certain court hearings,
and the Company has agreed to make limited monthly payments on account which were completed in October 2016. To the extent that
this assessment (either a higher or a reduced amount) is ultimately confirmed by the tax authorities, the Company believes it
has a very strong claim against certain professional advisors which would offset the liability in full. Accordingly, the Company
has made no provision for this liability in the nine months ended September 30, 2018 and the year ended December 31, 2017 respectively.
8.
|
CONSULTING
AND OTHER AGREEMENTS
|
The
following agreements were entered into or remained in force during the period ended September 30, 2018:
Consulting
Agreement with Fountainhead
In
March 2017 and effective April 1, 2017, the Company amended the Fountainhead Consulting Agreement (“the Amended Agreement”).
Under the Amended Agreement, fees of $450,000 are payable to Fountainhead, with an option to receive $5,000 per month in cash
and the remainder payable in Company Common Stock issued at the higher of $0.21 and the average price for the 30 days prior to
issuance, and deliverable at the end of each fiscal quarter. The Consulting Agreement also contains provisions for Fountainhead
to receive a higher proportion of its fees in cash subject to certain future liquidity events and Board approval. Under the Amended
Agreement, Fountainhead was granted options pursuant to the Vycor Medical, Inc. 2008 Stock Option Plan, to purchase 660,000 shares
of Company Common Stock at $0.27 per share. Vesting of these options was subject to the achievement of certain milestones; these
milestones were achieved and the options fully vested on September 30, 2018.
In
March 2018 Fountainhead was granted options pursuant to the Vycor Medical, Inc. 2018 Stock Option Plan, to purchase 660,000 shares
of Company Common Stock at an exercise price of $0.46 (the average closing price for the 5 trading days before the grant). Vesting
of these options is subject to the achievement of certain milestones by March 31, 2019.
During
the nine months ended September 30, 2018, under the terms of the Amended Agreement, Fountainhead received total fees of $337,500,
which were paid through the issuance of 963,215 shares of Company Common Stock. Also under the terms of the Agreement, Fountainhead
was issued $225,000 in fees accrued as at December 31, 2017 through the issuance of 705,841 shares of Company Common Stock.
9.
|
RELATED
PARTY TRANSACTIONS
|
Peter
Zachariou and David Cantor, directors of the Company, are investment managers of Fountainhead which owned, at September 30, 2018,
52% of the Company’s Common Stock and 70% of the Company’s Preferred D Stock. Adrian Liddell, Chairman, is a consultant
for Fountainhead.
As
referred to in Note 3, on January 24, 2018 the Company entered into the Amendment with EuroAmerican. regarding its $300,000 Note.
Under the Amendment, EuroAmerican granted a right of first refusal prior to converting or selling or the Note a) first to Vycor
to redeem the Note and accrued interest at face value and b) if not exercised second to Fountainhead to purchase the Note and
accrued interest at face value on the same terms.
In
March 2017 Fountainhead was granted options pursuant to the Vycor Medical, Inc. 2008 Stock Option Plan, to purchase 660,000 shares
of Company Common Stock at an exercise price of $0.27, subject to performance vesting conditions. These options became fully vested
in June 2018 following the achievement of the milestones.
In
March 2018 Fountainhead was granted options pursuant to the Vycor Medical, Inc. 2018 Stock Option Plan, to purchase 660,000 shares
of Company Common Stock at an exercise price of $0.46 (the average closing price for the 5 trading days before the grant). Vesting
of these options is subject to the achievement of certain milestones by March 31, 2019.
During
the nine months ended September 30, 2018, under the terms of the Consulting Agreement referred to in note 8, the Company issued
1,669,056 shares of Common Stock to Fountainhead for fees of $562,500 of which $225,000 was accrued at December 31, 2017.
During
the nine months ended September 30, 2018, the Company accrued an aggregate of $324,370 of Preferred D Stock dividends, of which
an aggregate of $309,424 Preferred D Stock dividends were in respect of related parties.
During
the nine months ended September 30, 2018 the Company issued unsecured loan notes to Fountainhead for a total of $163,000. The
loan notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary.
During
the period ended September 30, 2018, the Company issued unsecured loan notes to Peter Zachariou for a total of $30,000. The loan
notes bear interest at a rate of 10% and are due on demand or by their one-year anniversary.
Vycor
sells its neurosurgical devices in the US primarily direct to hospitals, and internationally through distributors who in turn
sell to hospitals. The sales to one international distributor represented 25% and 29%, respectively, of total sales for the three
months ended September 30, 2018 and 2017. The sales to three distributors represented 10%, 11% and 11%, respectively, of total
sales for the nine months ended September 30, 2018.. The sales to one distributor represented 17% of total sales for the nine
months ended September 30, 2017. The accounts receivable from one international distributor represented 42% of total accounts
receivable at September 30, 2018 and the accounts receivable from two distributors represented 12% and 16% of total accounts receivable
at December 31, 2017 respectively.
The
Company has evaluated the existence of events and transactions subsequent to the balance sheet date through the date the consolidated
financial statements were issued and has determined that there were no significant subsequent events or transactions which would
require recognition or disclosure in the financial statements.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
Forward
Looking Statements
This
Interim Report on Form 10-Q contains, in addition to historical information, certain forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 (“PLSRA”), Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”), and section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)
regarding Vycor Medical, Inc. (the “Company” or “Vycor,” also referred to as “us”, “we”
or “our”). Forward-looking statements give our current expectations or forecasts of future events. You can identify
these statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve
risks and uncertainties. Forward-looking statements include statements regarding, among other things, (a) our projected sales,
profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in our industries, (d) our future financing plans
and (e) our anticipated needs for working capital. They are generally identifiable by use of the words “may,” “will,”
“should,” “anticipate,” “estimate,” “plans,” “potential,” “projects,”
“continuing,” “ongoing,” “expects,” “management believes,” “we believe,”
“we intend” or the negative of these words or other variations on these words or comparable terminology. These statements
may be found under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and
“Description of Business,” as well as in this Form 10-Q generally. In particular, these include statements relating
to future actions, prospective products or product approvals, future performance or results of current and anticipated products,
sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any
or all of our forward-looking statements in this report may turn out to be inaccurate. They can be affected by inaccurate assumptions
we might make or by known or unknown risks or uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual
future results may vary materially as a result of various factors, including, without limitation, the risks outlined under “Risk
Factors” and matters described in this Form 10-Q generally. In light of these risks and uncertainties, there can be no assurance
that the forward-looking statements contained in this filing will in fact occur. You should not place undue reliance on these
forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and, except to the
extent required by federal securities laws, we undertake no obligation to publicly update any forward-looking statements, whether
as the result of new information, future events, or otherwise. We intend that all forward-looking statements be subject to the
safe harbor provisions of the PSLRA.
1.
Organizational History
The
Company was formed as a limited liability company under the laws of the State of New York on June 17, 2005 as “Vycor Medical
LLC”. On August 14, 2007, we converted into a Delaware corporation and changed our name to “Vycor Medical, Inc.”.
The Company’s listing went effective on February 2009 and on November 29, 2010 Vycor completed the acquisition of substantially
all of the assets of NovaVision, Inc. (“NovaVision”) and on January 4, 2012 Vycor, through its wholly-owned NovaVision
subsidiary, completed the acquisition of all the shares of Sight Science Limited (“Sight Science”).
2.
Overview of Business
Vycor
is dedicated to providing the medical community with innovative and superior surgical and therapeutic solutions and operates two
distinct business units within the medical device industry. Vycor Medical designs, develops and markets medical devices for use
in neurosurgery. NovaVision provides non-invasive rehabilitation therapies for those who have vision disorders resulting from
neurological brain damage such as that caused by a stroke. Both businesses adopt a minimally or non-invasive approach. Both technologies
have strong sales growth potential, address large potential markets and have the requisite regulatory approvals. The Company has
68 issued or allowed patents and a further 7 pending. The Company leverages joint resources across the divisions to operate in
a cost-efficient manner.
The
Company periodically engages in discussions with potential strategic partners for or purchasers of each or both of our operating
divisions.
Vycor
Medical
Vycor
Medical designs, develops and markets medical devices for use in neurosurgery. Vycor Medical’s ViewSite Brain Access System
(“VBAS”) is a next generation retraction and access system that was fully commercialized in early 2010 and is the
first significant technological change to brain tissue retraction in over 50 years in contrast to significant development in most
other neuro-surgical technologies. Vycor Medical is ISO 13485:2003 compliant, and VBAS has U.S. FDA 510(k) clearance and CE Marking
for Europe (Class III) for brain and spine surgeries, and regulatory approvals in Australia, Brazil, Canada, China, Korea, Japan,
Russia and Taiwan. Vycor has 23 granted and 6 pending patents worldwide.
NovaVision
NovaVision
provides non-invasive, computer-based rehabilitation targeted at a substantial and largely un-addressed market of people who have
lost their sight as a result of stroke or other brain injury, and has 45 granted patents.
Strategy
The Company is executing on a plan to achieve
a reduction in cash operating losses for both the Vycor Medical and NovaVision divisions. For Vycor Medical this includes in particular:
increasing market penetration in the US through increased educational progams and tight management of the distribution network;
increasing international growth particularly in Europe and other territories where we are not represented or under represented;
and continued new product development. The first phase of modification of the existing VBAS product range to make it more easy
to use with the most common IGS systems was completed in September 2017 and was well received by surgeons; we are continuing our
roll-out of this model through hospital inventories. The second phase of the development of further IGS integration will be completed
in 2019. We will also be exploring with surgeons and focus groups additional selected development work targeted at increasing
the range of procedures for which VBAS is applicable. For NovaVision, given the company’s resources, and the large size
and diversity of its end markets, we believe that the most efficient way to tackle the distribution of its broad range of patient
and professional products is by partnering with entities that have either direct access to the end users or established distribution
channels in the various target markets. The Company is in the process of identifying and talking to such partners. The range of
alternatives for NovaVision could comprise distribution and marketing partnerships, licensing, merger, sale and/or restructuring
of its activities.
Comparison
of the Three Months Ended September 30, 2018 to the Three Months Ended September 30, 2017
Revenue
and Gross Margin:
|
|
2018
|
|
|
2017
|
|
|
%
Change
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
399,450
|
|
|
$
|
326,843
|
|
|
|
22
|
%
|
NovaVision
|
|
$
|
56,763
|
|
|
$
|
52,230
|
|
|
|
9
|
%
|
|
|
$
|
456,213
|
|
|
$
|
379,073
|
|
|
|
20
|
%
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
357,674
|
|
|
$
|
277,324
|
|
|
|
29
|
%
|
NovaVision
|
|
$
|
51,739
|
|
|
$
|
46,417
|
|
|
|
11
|
%
|
|
|
$
|
409,413
|
|
|
$
|
323,741
|
|
|
|
26
|
%
|
Vycor
Medical recorded revenue of $399,450 from the sale of its products for the three months ended September 30, 2018, an increase
of $72,607 over the same period in 2017. Gross margin of 90% was recorded for the three months ended September 30, 2018 compared
to 85% for the same period in 2017. Gross margin is primarily affected by the domestic versus international revenue mix.
NovaVision
recorded revenues of $56,763 for the three months ended September 30, 2018, an increase of $4,533 over the same period in 2017,
and gross margin of 91%, compared to 89% for the same period in 2017.
Selling,
General and Administrative Expenses:
Selling,
general and administrative expenses decreased by $47,472 to $499,143 for the three months ended September 30, 2018 from $546,615
for the same period in 2017. Included within Selling, General and Administrative Expenses are non-cash charges for share based
compensation as the result of amortizing employee and non-employee shares, warrants and options which have been issued by the
Company over various periods. The charge for the three months ended September 30, 2018 was $133,500, a decrease of $8,437 over
$141,937 in 2017. Also included within Selling, General and Administrative Expenses are Sales Commissions, which increased by
$58,188 from $43,712 to $101,900 in 2018, reflecting a commission from a single direct sale to an international hospital. The
remaining Selling, General and Administrative expenses decreased by $97,223 from $360,966 to $263,743 in 2018.
An
analysis of the change in cash and non-cash G&A is shown in the table below:
|
|
Cash
G&A
|
|
|
Non-Cash
G&A
|
|
Commissions
|
|
$
|
58,188
|
|
|
$
|
-
|
|
Board,
financial and scientific advisory
|
|
|
(5,702
|
)
|
|
|
(8,438
|
)
|
Sales,
marketing and travel
|
|
|
(12,130
|
)
|
|
|
-
|
|
Payroll
|
|
|
(16,032
|
)
|
|
|
-
|
|
Legal,
professional and other consulting
|
|
|
(19,659
|
)
|
|
|
-
|
|
Other
(travel/regulatory/premises)
|
|
|
(43,699
|
)
|
|
|
-
|
|
Total
change
|
|
$
|
(39,034
|
)
|
|
$
|
(8,438
|
)
|
Interest
Expense:
Interest
comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the three months
ended September 30, 2018 was $5.923 compared to $0 for 2017. Other Interest income and expense for 2018 increased by $935 to $12,295
from $11,360 for 2017.
Comparison
of the Nine months Ended September 30, 2018 to the Nine months Ended September 30, 2017
Revenue
and Gross Margin:
|
|
Nine
months ended
|
|
|
|
September
30,
|
|
|
|
2018
|
|
|
2017
|
|
|
%
Change
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
930,553
|
|
|
$
|
949,053
|
|
|
|
-2
|
%
|
NovaVision
|
|
$
|
152,426
|
|
|
$
|
166,102
|
|
|
|
-8
|
%
|
|
|
$
|
1,082,979
|
|
|
$
|
1,115,155
|
|
|
|
-3
|
%
|
Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
Vycor Medical
|
|
$
|
821,240
|
|
|
$
|
824,176
|
|
|
|
0
|
%
|
NovaVision
|
|
$
|
138,609
|
|
|
$
|
148,226
|
|
|
|
-6
|
%
|
|
|
$
|
959,849
|
|
|
$
|
972,402
|
|
|
|
-1
|
%
|
Vycor
Medical recorded revenue of $930,553 from the sale of its products for the nine months ended September 30, 2018, a decrease of
$18,500, or 2%, over the same period in 2017. Following the release of the enhanced VBAS model at the end of September 2017, Vycor
took the decision in February 2018, based on surgeon feedback, to accelerate the roll-out of the enhanced model and cease shipment
of the previous model. As a result, manufacturing of the enhanced model needed to be accelerated and this caused some delays and
lost revenue, although this was largely caught up by the end of the nine month period. Gross margin of 88% was recorded for the
nine months ended September 30, 2018 compared to 87% for the same period in 2017.
NovaVision
recorded revenues of $152,426 for the nine months ended September 30, 2018, a decrease of $13,676 over the same period in 2017,
and gross margin of 91%, compared to 89% for the same period in 2017.
Selling,
General and Administrative Expenses:
Selling,
general and administrative expenses decreased by $25,799 to $1,684,445 for the nine months ended September 30, 2018 from $1,710,244
for the same period in 2017. Included within Selling, General and Administrative Expenses are non-cash charges for share based
compensation as the result of amortizing employee and non-employee shares, warrants and options which have been issued by the
Company over various periods. The charge for the nine months ended September 30, 2018 was $492,125 an increase of $69,820 over
$422,305 in 2017. Also included within General and Administrative Expenses are Sales Commissions, which increased by $25,160 to
$187,859, reflecting a commission from a single direct sale to an international hospital. The remaining General and Administrative
expenses decreased by $120,780 from $1,125,241to $1,004,461.
An
analysis of the change in cash and non-cash G&A is shown in the table below:
|
|
Cash
G&A
|
|
|
Non-Cash
G&A
|
|
Payroll
|
|
$
|
-
|
|
|
$
|
3,262
|
|
Sales,
marketing and travel
|
|
|
(4,531
|
)
|
|
|
-
|
|
Legal,
professional and other consulting
|
|
|
(17,432
|
)
|
|
|
-
|
|
Board,
financial and scientific advisory
|
|
|
(18,714
|
)
|
|
|
66,558
|
|
Commissions
|
|
|
25,161
|
|
|
|
|
|
Other
(travel/regulatory/premises)
|
|
|
(80,103
|
)
|
|
|
-
|
|
Total
change
|
|
$
|
(95,619
|
)
|
|
$
|
69,820
|
|
Interest
Expense:
Interest
comprises expense on the Company’s debt and insurance policy financing. Related Party Interest expense for the nine months
ended September 30, 2018 was $6,570 compared to $679 for 2017. Other Interest expense for 2018 increased by $4,288 to $36,505
from $32,217 for 2017.
Liquidity
and Capital Resources
Liquidity
The
following table shows cash flow and liquidity data for the periods ended September 30, 2018 and December 31, 2017:
|
|
September
30, 2018
|
|
|
December
31, 2017
|
|
|
$
Change
|
|
Cash
|
|
$
|
90,130
|
|
|
$
|
206,213
|
|
|
$
|
(116,083
|
)
|
Accounts receivable, inventory
and other current assets
|
|
$
|
563,366
|
|
|
$
|
402,295
|
|
|
$
|
161,071
|
|
Total current liabilities
|
|
$
|
(1,829,699
|
)
|
|
$
|
(1,368,015
|
)
|
|
$
|
(461,684
|
)
|
Working capital
|
|
$
|
(1,176,203
|
)
|
|
$
|
(759,507
|
)
|
|
$
|
(416,696
|
)
|
Cash provided by financing
activities
|
|
$
|
221,473
|
|
|
$
|
863,851
|
|
|
$
|
(642,378
|
)
|
Operating
Activities
. Cash used in operating activities comprises net loss adjusted for non-cash items and the effect of changes in
working capital and other activities. The net repayment of normal insurance financing should also be taken into account when considering
cash used in operating activities.
The
following table shows the principle components of cash used in operating activities during the nine months ended September 30,
2018 and 2017, with a commentary of changes during the periods and known or anticipated future changes:
|
|
September
30, 2018
|
|
|
September
30, 2017
|
|
|
$
Change
|
|
Net loss
|
|
$
|
(897,399
|
)
|
|
$
|
(1,101,909
|
)
|
|
$
|
204,510
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to
cash used in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization and
depreciation of assets
|
|
|
136,203
|
|
|
|
222,643
|
|
|
|
(86,440
|
)
|
Share based compensation
|
|
|
492,125
|
|
|
|
309,805
|
|
|
|
182,320
|
|
Accrued share based
compensation
|
|
|
-
|
|
|
|
112,500
|
|
|
|
(112,500
|
)
|
Warrant Issuance
Expense
|
|
|
-
|
|
|
|
120,788
|
|
|
|
(120,788
|
)
|
Other
|
|
|
3,139
|
|
|
|
3,532
|
|
|
|
(393
|
)
|
|
|
|
631,467
|
|
|
|
769,268
|
|
|
|
(137,801
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss adjusted for non-cash items
|
|
|
(265,932
|
)
|
|
|
(332,641
|
)
|
|
|
66,709
|
|
Changes in working capital
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable,
accounts payable and accrued liabilities
|
|
|
(33,193
|
)
|
|
|
(135,812
|
)
|
|
|
102,619
|
|
Inventory
|
|
|
(7,565
|
)
|
|
|
(10,678
|
)
|
|
|
3,113
|
|
Prepaid expenses
and net insurance financing repayments
|
|
|
6,560
|
|
|
|
26,299
|
|
|
|
(19,739
|
)
|
Accrued
interest (not paid in cash)
|
|
|
42,471
|
|
|
|
36,582
|
|
|
|
5,889
|
|
|
|
|
8,273
|
|
|
|
(83,609
|
)
|
|
|
91,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in
operating activities, adjusted for net insurance repayments
|
|
$
|
(257,659
|
)
|
|
$
|
(416,250
|
)
|
|
$
|
158,591
|
|
The
adjustments to reconcile net loss to cash of $631,467 in the period have no impact on liquidity. The decrease in net loss (as
adjusted for non-cash items) by $66,709 to $265,932 was primarily a result of reduced expenses. During the first quarter of 2017
a number of material and unusual items impacted the net accounts receivable, accounts payable and accrued liabilities; these were
reversed in the first quarter of 2018. In addition, the Company typically renews a large number of annual expense contracts such
as insurances and licenses during the first nine months, which has an impact on cash usage. The Company is in the process of modifying
the VBAS product suite to make it easier to integrate with IGS. The first phase of this project was completed in September 2017
and additional inventory of $95,290 was purchased during the period. The Company anticipates completing the second phase of this
project during the next six months and as a result will purchase additional new inventory of approximately $40,000.
Investing
Activities.
Cash used in investing activities for the nine months ended September 30, 2018 was $56,604, which primarily reflected
expenditure on the second phase of modifying the VBAS product suite to make it easier to integrate with IGS. The Company anticipates
additional expenditures for this second phase during the next six months of approximately $80,000.
Financing
Activities.
During the period ending September 30, 2018 the Company received funds of $193,000 in respect of loans from Fountainhead
and Peter Zachariou (the Company’s Chief Executive Officer).
Liquidity
and Plan of Operations, Ability to Continue as a Going Concern
The
accompanying unaudited consolidated financial statements have been prepared assuming that the Company will continue as a going
concern. The Company has incurred losses since its inception, including a net loss of $897,399 and $1,101,909 for the nine months
ended September 30, 2018 and 2017 respectively and has not generated cash flows from operations. As of September 30, 2018 the
Company had a working capital deficiency of $315,053, excluding related party liabilities of $861,150. As a result, these conditions,
among others, raise substantial doubt regarding our ability to continue as a going concern. The financial statements do not include
any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification
of liabilities that may result from the outcome of this uncertainty.
As described earlier in this ITEM 2 “
Strategy
”,
the Company is executing on a plan to achieve a reduction in cash operating losses for both the Vycor Medical and NovaVision divisions.
For Vycor Medical this includes in particular: increasing market penetration in the US through increased educational progams and
tight management of the distribution network; increasing international growth particularly in Europe and other territories where
we are not represented or under represented; and continued new product development. The first phase of modification of the existing
VBAS product range to make it more easy to use with the most common IGS systems was completed in September 2017 and was well received
by surgeons; we are continuing our roll-out of this model through hospital inventories. The second phase of the development of
further IGS integration will be completed in 2019. We will also be exploring with surgeons and focus groups additional selected
development work targeted at increasing the range of procedures for which VBAS is applicable. For NovaVision, given the company’s
resources, and the large size and diversity of its end markets, we believe that the most efficient way to tackle the distribution
of its broad range of patient and professional products is by partnering with entities that have either direct access to the end
users or established distribution channels in the various target markets. The Company is in the process of identifying and talking
to such partners. The range of alternatives for NovaVision could comprise distribution and marketing partnerships, licensing,
merger, sale and/or restructuring of its activities.
However,
the Company believes it may not have sufficient cash to meet its various cash needs through November 30, 2019 unless the Company
is able to obtain additional cash from the issuance of debt or equity securities. Included within the working capital deficiency
above is a term note for $300,000 to EuroAmerican Investment Corp. (“EuroAmerican”), together with accrued interest
of $220,666, which has a maturity date of December 31, 2018, having been extended on a number of occasions from its initial due
date of June 11, 2011. The Company intends to seek an extension to the note, although it is not known whether the note will be
extended or the terms of any extension. Fountainhead, the Company’s largest shareholder, is currently providing working
capital funding to the Company on an as-needed basis, although there is no guarantee that this will continue to be the case. The
Company may consider seeking additional equity or debt funding, although there is no assurance that this would be available on
acceptable terms or at all. If adequate funds are not available, the Company may have to delay or curtail development or commercialization
of products, or cease some of its operations.
Critical
Accounting Policies and Estimates
Uses
of estimates in the preparation of financial statements
The
preparation of unaudited consolidated financial statements in conformity with generally accepted accounting principles requires
management to make estimates and assumptions that affect the amounts reported in the unaudited consolidated financial statements
and accompanying notes. Actual results could differ from those estimated. To the extent management’s estimates prove to
be incorrect, financial results for future periods may be adversely affected. Significant estimates and assumptions contained
in the accompanying unaudited consolidated financial statements include management’s estimate of the allowance for uncollectible
accounts receivable, amortization of intangible assets, and the fair values of options and warrant included in the determination
of debt discounts and share-based compensation.
A
detailed description of our significant accounting policies can be found in our most recent Annual Report on Form 10-K for the
year ended December 31, 2017.