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") regardingVycor 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 theState of New York onJune 17, 2005 as "Vycor Medical LLC ". OnAugust 14, 2007 , we converted into aDelaware corporation and changed our name to "Vycor Medical, Inc. ". The Company's listing went effective onFebruary 2009 and onNovember 29, 2010 Vycor completed the acquisition of substantially all of the assets ofNovaVision, Inc. ("NovaVision") and onJanuary 4, 2012 Vycor, through its wholly-ownedNovaVision subsidiary, completed the acquisition of all the shares ofSight Science Limited ("Sight Science"). 17 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 thosewho 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 65 issued or allowed patents and a further 9 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. InApril 2020 , the board of Vycor took the decision to close the German operations ofNovaVision , including the German office andNovaVision GmbH , and instead migrate to a licensed business model; inJune 2020 Vycor announced that it would be entering into a license agreement and transition agreement (the "Agreements") withHelferApp GmbH , a cognitive therapy specialist. Under the Agreements, HelferApp is licensed to provideNovaVision's products and therapies inGermany ,Austria andSwitzerland to patients and professionals; and has assumed responsibility for the current patients ofNovaVision in the territory. The NovaVision German office was closed effectiveJune 30, 2020 .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 13485:2016 and MDSAP (Medical Device Single Audit Program) certified, and VBAS hasU.S. FDA 510(k) clearance and CE Marking forEurope (Class III) for brain and spine surgeries, and regulatory approvals in a number of other international markets.Vycor Medical has 27 granted and 9 pending patents.NovaVision
Strategy The Company is continuing to execute on a plan to achieve revenue growth and a reduction in cash operating losses1. ForVycor Medical this plan includes in particular: increasing market penetration in the US through broadening of the distribution network and programs to increase penetration in existing hospitals; increasing international growth in territories where we are not represented or under represented; and continued new product development. The first phase of the modification of the existing VBAS product range to make it more compatible with the most common IGS systems was completed inSeptember 2017 and has been well received by surgeons, resulting in increased hospital penetration and revenues particularly in the US. The second phase of the development of further IGS integration is complete, subject to regulatory clearances and approvals. Upon regulatory clearances and product release of this new VBAS AC model range the Company intends to conduct a multi-center study to provide additional clinical data on the product. We will also be exploring with surgeons and focus groups additional selected development work targeted at increasing the ease and applicability of our products to additional common procedures. ForNovaVision , 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 a desire and financial wherewithal to leverage theNovaVision therapy platform. As a result, the Company has now closed the NovaVision German office and is entering into a license agreement with HelferApp, a cognitive therapy specialist, forGermany ,Austria andSwitzerland , and is seeking similar partnerships in other territories with regional companies able to leverageNovaVision's clinically supported vision therapies. Management is also open to a broad range of alternatives forNovaVision as a whole, which could comprise distribution and marketing partnerships, licensing, merger or sale. The NovaVision German operation accounted for a very substantial proportion of Vycor's operating cash loss1 during the year endedDecember 31, 2019 . This proportion has been reduced during the nine months endedSeptember 30, 2020 for two reasons: firstly, the selling, general and administrative expenses of NovaVision Germany have been reduced as the operation has been wound down; and secondly due to the impact on Vycor revenues from Covid-19 discussed below.
1 Operating Loss before Depreciation, Amortization and non-cash Stock Compensation
18 COVID-19 InDecember 2019 , an outbreak of a novel strain of coronavirus (COVID-19) originated inWuhan, China , and has since spread to a number of other countries, includingthe United States . OnMarch 11, 2020 , theWorld Health Organization characterized COVID-19 as a pandemic. In addition, as of the time of the filing of this Form 10-Q, several states inthe United States remain in states of emergency, and travel restrictions continue to be applied in several countries around the world, includingthe United States .Vycor Medical experienced a reduction in demand during the three months endedSeptember 30, 2020 in the US andEurope . Although neurosurgery is not considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the nine months endedSeptember 30, 2020 and could continue to do so. In addition, sales and marketing efforts by Vycor's representatives have been disrupted or curtailed due to lockdown and social distancing, and this has and may continue to hinder the recovery of revenues. While our operations are principally located inthe United States , and our sub-contract manufacturers are located inthe United States , we participate in a global supply chain, and the existence of a worldwide pandemic, the fear associated with COVID-19, or any, pandemic, and the reactions of governments around the world in response to COVID-19, or any, pandemic, to regulate the flow of labor and products and impede the travel of personnel, may impact our ability to conduct normal business operations, which could adversely affect our results of operations and liquidity. Disruptions to our supply chain and business operations, or to our suppliers' or customers' supply chains and business operations, could include disruptions from the closure of supplier and manufacturer facilities, interruptions in the supply of raw materials and components, personnel absences, or restrictions on the shipment of our or our suppliers' or customers' products, any of which could have adverse ripple effects on our manufacturing output and delivery schedule. Although we have implemented business continuity plans for our offices and personnel to enable continuity of service remotely, if a critical number of our employees become too ill to work, or we are not able to access a sufficient quantity of our inventory for shipment due to enforced office closures, our production ability could be materially adversely affected in a rapid manner. Similarly, if our customers experience adverse business consequences due to COVID-19, or any other, pandemic, demand for our products could also be materially adversely affected in a rapid manner. Global health concerns, such as COVID-19, could also result in social, economic, and labor instability in the countries and localities in which we or our suppliers and customers operate. Any of these uncertainties could have a material adverse effect on our business, financial condition or results of operations.
Comparison of the Three Months Ended
Revenue and Gross Margin: Three months ended September 30, 2020 2019 % Change Revenue: Vycor Medical$ 250,648 $ 301,053 -17 % NovaVision$ 25,277 $ 21,831 16 %$ 275,925 $ 322,884 -15 % Gross Profit Vycor Medical$ 211,089 $ 273,146 -23 % NovaVision$ 24,285 $ 20,776 17 %$ 235,374 $ 293,922 -20 %Vycor Medical recorded revenue of$250,648 from the sale of its products for the three months endedSeptember 30, 2020 , a decrease of$50,405 over the same period in 2019. Sales of VBAS devices have been significantly disrupted during the 2020 period in the US and internationally by COVID-19. Although neurosurgery is not considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the three months endedSeptember 30, 2020 . In addition, sales and marketing efforts by Vycor's representatives have been disrupted or curtailed due to lockdown and social distancing, and this has hindered the recovery of revenues. Sales in the three months endedSeptember 30, 2020 showed some recovery over the three month period endedJune 30, 2020 , increasing by$31,651 or 14%, primarily in the US. Gross margin of 84% and 91% was recorded for the three months endedSeptember 30, 2020 and 2019, respectively.NovaVision recorded revenues of$25,277 for the three months endedSeptember 30, 2020 , an increase of$3,446 over the same period in 2019. Gross margin was 96%, compared to 95% for the same period in 2019. 19
Selling, General and Administrative Expenses:
Selling, general and administrative expenses decreased by$17,121 to$427,250 for the three months endedSeptember 30, 2020 from$444,371 for the same period in 2019. Included within Selling, General and Administrative Expenses are non-cash charges for stock 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 endedSeptember 30, 2020 was$126,500 , a$7,000 decrease from the charge in 2019 of$133,500 , following the departure from theBoard of Oscar Bronsther fromJuly 1, 2020 . Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by$3,955 from$56,761 to$52,806 in 2020, reflecting the reduced level of sales in the US due to COVID-19.
The remaining Selling, General and Administrative expenses decreased by
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
Legal, patent, audit/accounting, regulatory (11,872 ) - Board, financial and scientific advisory (6,075 ) (7,000 ) Payroll (2,380 ) - Other (sales/travel/regulatory/premises) 14,161 -
Commissions (3,955 ) - Total change (10,121 ) (7,000 ) Interest Expense: Interest comprises expense on the Company's debt and insurance policy financing. Related Party Interest expense for the three months endedSeptember 30, 2020 was$7,836 compared to$5,315 for 2019. Other Interest expense for the three months endedSeptember 30, 2020 was$12,099 compared to$12,109 for 2019. Comparison of the Nine Months EndedSeptember 30, 2020 to the Nine Months EndedSeptember 30, 2019 Revenue and Gross Margin: September 30, 2020 2019 % Change Revenue: Vycor Medical$ 776,932 $ 988,786 -21 % NovaVision$ 73,498 $ 72,607 1 %$ 850,430 $ 1,061,393 -20 % Gross Profit Vycor Medical$ 683,125 $ 895,484 -24 % NovaVision$ 68,967 $ 68,463 1 %$ 752,092 $ 963,947 -22 %Vycor Medical recorded revenue of$776,932 from the sale of its products for the nine months endedSeptember 30, 2020 , a decrease of$211,854 . Sales of VBAS devices have been significantly disrupted, particularly from March to June, in the US and internationally by COVID-19 Although neurosurgery is not considered an elective procedure, general hospital dislocation and diversion of resources away from non-emergency surgeries, or surgeries that can be postponed for a short period without harm, has impacted our revenues during the six months endedSeptember 30, 2020 . In addition, sales and marketing efforts by Vycor's representatives have been disrupted or curtailed due to lockdown and social distancing, and this has hindered the recovery of revenues. Gross margin of 88% was recorded for the nine months endedSeptember 30, 2020 versus 91% for the same period in 2019.
NovaVision recorded revenues of$73,498 for the nine months endedSeptember 30, 2020 , an increase of$891 over the same period in 2019 and gross margin of 94%, compared to 94% for the same period in 2019. 20
Selling, General and Administrative Expenses:
Selling, general and administrative expenses decreased by$84,111 to$1,260,742 for the nine months endedSeptember 30, 2020 from$1,344,853 for the same period in 2019. 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 endedSeptember 30, 2020 was$393,500 , a decrease of$7,940 over$401,440 in 2019, following the departure from theBoard of Oscar Bronsther fromJuly 1, 2020 . Also included within Selling, General and Administrative Expenses are Sales Commissions, which decreased by$38,259 from$187,622 to$149,363 , reflecting the reduced level of sales in the US due to COVID-19. The remaining Selling, General and Administrative expenses decreased by$37,912 from$755,791 to$717,879 . Regulatory fees reduced by$49,367 reflecting the completion of the transition to a new EU Notified Body for Vycor; patent fees reduced by$20,296 reflecting the level of patent filing and prosecution activity in the 2019 period; the professional fees related to the closure of NovaVision Germany and the license agreement resulted accounting and legal
fees increasing by$17,303 . 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
Legal, patent, audit/accounting, regulatory (47,495 ) - Board, financial and scientific advisory (18,915 ) (7,000 ) Sales, marketing and travel (7,215 ) - Payroll 12,234 (939 ) Other (travel/regulatory/premises) 23,478 -
Commissions (38,259 ) - Total change (76,172 ) (7,939 ) Interest Expense: Interest comprises expense on the Company's debt and insurance policy financing. Related Party Interest expense for the nine months endedSeptember 30, 2020 was$21,846 compared to$15,331 for 2019. Other Interest expense for the nine months endedSeptember 30, 2020 was$36,033 compared to$36,074 for 2019.
Income (loss) from Discontinued Operations:
The reduction in operating loss for the three and nine months endedSeptember 30, 2020 compared to the same periods in 2019, from$26,083 to$13,069 and from$96,113 to$51,294 , respectively, is primarily due to a reduction in Selling, general and administrative expenses as a result of the wind-down of operations inGermany . 21 Liquidity
The following table shows cash flow and liquidity data for the periods ended
September 30, 2020 December 31, 2019 $ Change Cash$ 74,935 $ 60,717$ 14,218 Accounts receivable, inventory and other current assets$ 409,969 $ 595,715$ (185,746 ) Total current liabilities$ (2,848,749 ) $ (2,446,406 ) $ (402,343 ) Working capital$ (2,363,845 ) $ (1,789,974 ) $ (573,871 ) Cash provided by financing activities$ 307,634 $ 43,117$ 264,517
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, 2020 September 30, 2019 $ Change Net loss $ (622,122 ) $ (575,211 )$ (46,911 ) Adjustments to reconcile net loss to cash used in operating activities: Amortization and depreciation of assets $ 44,922 $ 46,371$ (1,449 ) Share based compensation $ 393,500 $ 401,440$ (7,940 ) Other $ 9,418 $ 9,418 $ 0 $ 447,840 $ 457,229$ (9,389 ) Net loss adjusted for non-cash items $ (174,282 ) $ (117,982 )$ (56,300 ) Changes in working capital Accounts receivable $ 137,154 $ 44,521$ 92,633 Accounts payable and accrued liabilities $ (231,277 ) $ 78,700$ (309,977 ) Inventory $ 19,221 $ (34,455 )$ 53,676 Prepaid expenses and net insurance financing repayments $ 21,695 $ (8,065 )$ 29,760 Accrued interest (not paid in cash) $ 57,879 $ 51,233$ 6,646 Changes in discontinued operations, net $ (54,218 ) $ 497$ (54,715 ) $ (49,546 ) $ 132,431$ (181,977 ) Cash provided by (used in) operating activities, adjusted for net insurance repayments $ (223,828 ) $ 14,449$ (238,277 ) 22 The adjustments to reconcile net loss to cash of$174,282 in the period have no impact on liquidity. The change in Net loss adjusted for non-cash items of ($56,300 ) was primarily due to the impact of COVID-19 on the Vycor division sales, which also accounts for the reduction in accounts receivable of$137,154 . AtDecember 31, 2019 there was an increase in accounts payable and accrued liabilities mainly due to expenditure on regulatory for the transition to a new EU Notified Body, and regulatory and testing for the VBAS development occurring during the fourth quarter. The change in accounts payable and accrued liabilities of$231,277 was mainly due to the settlement of these accounts. The net change of$54,218 in discontinued operations comprised a reduction of$72,331 in liabilities being transferred to the license partner,NovaVision, Inc. or eliminated; offset by a$18,113 reduction in assets being to the license partner,NovaVision, Inc. or written off. Additional inventory of$40,559 was purchased during the nine months endedSeptember 30, 2020 as part of normal production, and the Company anticipates purchasing additional new inventory of approximately$80,000 during the next twelve months. Investing Activities. Cash used in investing activities of continuing operations for the nine months endedSeptember 30, 2020 was$60,132 , which 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, including work to obtain regulatory clearances and approvals, of approximately$40,000 . The$9,574 change in investing activities of discontinued operations was due the writing off of long term assets. Financing Activities. During the nine months endedSeptember 30, 2020 the Company received funds of$80,000 in respect of loans from Fountainhead. The Company also received a loan of$58,600 during the period, pursuant to the Paycheck Protection Program (the "PPP") under Division A, Title I of the CARES Act, and a$150,000 loan from theSmall Business Administration ("SBA") EIDL program.
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$946,492 for the nine months endedSeptember 30, 2020 and has not generated sufficient positive cash flows from operations. As ofSeptember 30, 2020 the Company had a working capital deficiency of$688,725 , excluding related party liabilities of$1,675,120 . These conditions, among others, raise substantial doubt regarding our ability to continue as a going concern. The unaudited consolidated 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 continuing to execute on a plan to achieve revenue growth and a reduction in cash operating losses2. ForVycor Medical this plan includes in particular: increasing market penetration in the US through broadening of the distribution network and programs to increase penetration in existing hospitals; increasing international growth in territories where we are not represented or under represented; and continued new product development. The first phase of the modification of the existing VBAS product range to make it more compatible with the most common IGS systems was completed inSeptember 2017 and has been well received by surgeons, resulting in increased hospital penetration and revenues particularly in the US. The second phase of the development of further IGS integration is complete subject to regulatory clearances and approvals. Upon regulatory clearances and product release of this new VBAS AC model range the Company intends to conduct a multi-center study to provide additional clinical data on the product. We will also be exploring with surgeons and focus groups additional selected development work targeted at increasing the ease and applicability of our products to additional common procedures. ForNovaVision , 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 a desire and financial wherewithal to leverage theNovaVision therapy platform. As a result, the Company has now closed the NovaVision German office and is entering into a license agreement with HelferApp, a cognitive therapy specialist, forGermany ,Austria andSwitzerland , and is seeking similar partnerships in other territories with regional companies able to leverageNovaVision's clinically supported vision therapies. Management is also open to a broad range of alternatives forNovaVision as a whole, which could comprise distribution and marketing partnerships, licensing, merger or sale.
2 Operating Loss before Depreciation, Amortization and non-cash Stock Compensation
23 However, the Company believes it may not have sufficient cash to meet its various cash needs throughNovember 30, 2021 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 toEuroAmerican Investment Corp. ("EuroAmerican"), together with accrued interest of$316,798 , which has a maturity date ofDecember 31, 2020 , having been extended on a number of occasions from its initial due date ofJune 11, 2011 . At this time, it is not known whether any further extension of the note beyondDecember 31, 2020 will be available. Fountainhead, the Company's largest shareholder, has provided 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 stock-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
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