UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
March 29, 2019
Vycor Medical, Inc.
(Exact name of registrant)
Delaware | 001-34932 | 20-3369218 | ||
(State of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
951 Broken Sound Parkway, Suite 320
Boca Raton, FL 33487
(Address of principal executive offices and zip code)
561-558-2020
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
[ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
[ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
[ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
[ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 2.02. | Results of Operations and Financial Conditions |
Item 9.01 | Financial Statements and Exhibits |
SIGNATURES |
Item 2.02. Results of Operations and Financial Conditions
The information in this report and the exhibit attached hereto are being furnished pursuant to Item 2.02 of Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall they be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the Securities Act of 1934 or the Securities Act of 1933, except as shall be expressly set forth by specific reference to such filing.
On March 29, 2019, we issued a press release regarding our financial results for the year ended December 31, 2018. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K.
Non-GAAP Measures
We make reference to non-GAAP financial information in this press release together with a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures. Specifically, we have provided non-GAAP Cash Operating Expenses and non-GAAP Cash Operating Loss measures that exclude Depreciation, Amortization and non-cash Stock Compensation.
We believe that these non-GAAP financial measures provide investors with insight into what is used by management to conduct a more meaningful and consistent comparison of our ongoing operating results and trends, compared with historical results. This presentation is also consistent with the measures management uses to measure the performance of ongoing operating results against prior periods and against our internally developed targets. There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP and the reconciliation of non-GAAP financial measures in this press release.
Item 9.01. Financial Statements and Exhibits.
(d) | Exhibits. |
Exhibit 99.1. | Vycor Medical, Inc. Press Release dated March 29, 2019. |
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 hereunto duly authorized.
VYCOR MEDICAL, INC. | ||
By: | /s/ Peter Zachariou | |
Name: | Peter Zachariou | |
Title: | Chief Executive Officer |
Dated: March 29, 2019
Exhibit 99.1
Vycor Medical Reports Financial Results for the year ended December 31st, 2018
BOCA RATON, FL (March 29, 2018) – Vycor Medical, Inc. (Vycor) (OTCQB: VYCO), a provider of innovative and superior surgical and therapeutic solutions, reported financial results for the year ended December 31, 2018.
Highlights
● | Vycor has been working on improving how its VBAS integrates with the most common Image Guidance System (“IGS”) pointers on the market; the first phase of this was completed and the Company started shipping its enhanced VBAS model at the end of September. Vycor took the decision in February 2018, based on surgeon feedback, to cease shipment of its previous model. As a result, manufacturing of the enhanced model needed to be accelerated and this caused some delays, which resulted in lost revenue through the first six months of the year, at which point sales had decreased by 15% over the same period in 2017. However, as the delays were reversed and with positive surgeon adoption of the newly enhanced VBAS, sales accelerated in the second half of the year by 40% compared to the same period in 2017, and actually ended the year with revenues increasing 11% over 2017. | |
● | The second phase of development of the VBAS IGS device is now well advanced with product being manufactured for further testing and regulatory submission, and we will also be exploring with surgeons and complementary product manufacturers additional selected development work targeted at increasing the ease and applicability of our VBAS range. | |
● | NovaVision currently has approximately 260 patients undergoing its therapies in the US and internationally. Patient compliance continues to be strong, with 75% of patients who have started since the introduction of the Internet model completing the full 6 months of VRT, and over 30% of patients extending their therapy period beyond 6 months. NovaVision has also placed its Professional Model with 17 clinics or rehabilitation centers since it started the soft marketing of this model. | |
● | Under Vycor’s ownership, NovaVision has gone from a business with a prototype therapy to one with a broad suite of proven patient and professional therapies and diagnostic products, utilizing a flexible range of delivery technologies. The therapies are protected by 45 patents and have a significant body of clinical data which continues to be added to and which demonstrates their efficacy. Management has made clear over the last year, however, that given the company’s resources, and the large size and diversity of NovaVision’s end markets, it believes the most efficient way to fulfill NovaVision’s potential is through partnerships. The range of alternatives for NovaVision could comprise distribution and marketing partnerships, licensing, merger or sale. |
Management Commentary
“The enhanced VBAS model that we released in the fourth quarter of 2017 has been well received by the market,” said Peter Zachariou, CEO of Vycor Medical. “The strong performance of the division in the second half demonstrates that the IGS development work we are carrying out for our VBAS product will position the business well for the future, and we look forward to completing that development during 2019, subject to regulatory clearances”.
“Our stated focus on the reduction of cash burn has continued. Our Cash Operating Loss1 despite our investment in manufacturing and new products, reduced to $207,000 for the year compared to $463,000 for 2017, and the Company generated a Cash Operating Profit2 in both the third and fourth quarters of the year.”
Year ended December 31, 20178 Financial Results
Revenue totaled $1,509,000 in the year ended December 31, 2018, as compared to $1, 385,000 for the prior year, an increase of 9%. Vycor Medical’s revenue increased by $133,000 or 11% and generated a gross margin of 88% compared to 83% in 2017. NovaVision recorded revenues of $198,019 for the year ended December 31, 2018, a decrease of $8,889 from 2017, and gross margin of 91%, compared to 89% for 2017.
Operating Expenses in the year ended December 31, 2018 totaled $2,657,000 as compared to $2,470,000 in 2017, of which $308,000 was in respect of the impairment charge under ASC 360-10-35 against NovaVision’s assets. Cash Operating Expenses2 were $1,547,000 as compared to $1,620,000. Operating Loss was $1,318,000, compared to $1,313,000 for 2017, and Cash Operating Loss2 was $207,000, as compared to $463,000, a reduction of 55%.
Net Loss for the year ended December 31, 2018 was $1,379,000 as compared to $1, 477,000 in 2017.
1 Operating Profit/Loss before Depreciation, Amortization and non-cash Stock Compensation. See Reconciliation table
2 Operating Expenses before Depreciation, Amortization and non-cash Stock Compensation. See Reconciliation table
About Vycor Medical, Inc.
Vycor Medical (OTCQB: VYCO) is dedicated to providing the medical community with innovative and superior surgical and therapeutic solutions. The company has a portfolio of FDA cleared medical solutions that are changing and improving lives every day. The company operates two business units: Vycor Medical and NovaVision, both of which adopt a minimally or non-invasive approach.
For the latest information on the company, including media and other coverage, and to learn more, please go online at www.vycormedical.com, www.vycorvbas.com or www.novavision.com.
Non-GAAP Measures
We make reference to non-GAAP financial information in this press release together with a reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures. Specifically, we have provided non-GAAP Cash Operating Expenses and non-GAAP Cash Operating Loss measures that exclude Depreciation, Amortization and non-cash Stock Compensation.
We believe that these non-GAAP financial measures provide investors with insight into what is used by management to conduct a more meaningful and consistent comparison of our ongoing operating results and trends, compared with historical results. This presentation is also consistent with the measures management uses to measure the performance of ongoing operating results against prior periods and against our internally developed targets. There are limitations in using these non-GAAP financial measures because they are not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. These non-GAAP financial measures should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP and the reconciliation of non-GAAP financial measures in this press release.
Safe Harbor Statement
Information in this document constitute forward-looking statements or statements which may be deemed or construed to be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “forecast”, “anticipate”, “estimate”, “project”, “intend”, “expect”, “should”, “believe”, and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve, and are subject to known and unknown risks, uncertainties and other factors which could cause Vycor Medical’s actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. The risks, uncertainties and other factors are more fully discussed in Vycor Medical’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements attributable to Vycor Medical herein are expressly qualified in their entirety by the above-mentioned cautionary statement. Vycor Medical disclaims any obligation to update forward-looking statements contained in this estimate, except as may be required by law.
VYCOR MEDICAL, INC.
Consolidated Statements of Comprehensive Loss
For the Twelve months ended December 31, | ||||||||
2018 | 2017 | |||||||
Revenue | $ | 1,509,330 | $ | 1,384,971 | ||||
Cost of Goods Sold | 169,598 | 201,363 | ||||||
Gross Profit | 1,339,732 | 1,183,608 | ||||||
Operating expenses: | ||||||||
Research and development | - | 3,015 | ||||||
Depreciation and Amortization | 166,386 | 275,416 | ||||||
Selling, general and administrative | 2,183,505 | 2,185,769 | ||||||
Impairment of assets | 307,576 | - | ||||||
Total Operating expenses | 2,657,467 | 2,464,200 | ||||||
Operating loss | (1,317,735 | ) | (1,280,592 | ) | ||||
Other income (expense) | ||||||||
Interest expense: Other | (48,800 | ) | (48,523 | ) | ||||
Interest expense: Related Party | (11,434 | ) | (679 | ) | ||||
Gain (loss) on foreign currency exchange | (1,387 | ) | 1,392 | |||||
Gain (loss) on other income and expense | 0 | 4,028 | ||||||
Warrant issuance expense | - | (120,788 | ) | |||||
Total Other Income (expense) | (61,621 | ) | (164,570 | ) | ||||
Loss Before Credit for Income Taxes | (1,379,356 | ) | (1,445,162 | ) | ||||
Credit for income taxes | - | - | ||||||
Net Loss | (1,379,356 | ) | (1,445,162 | ) | ||||
Preferred stock dividends | (324,970 | ) | (324,970 | ) | ||||
Net Loss available to common shareholders | (1,704,326 | ) | (1,770,132 | ) | ||||
Comprehensive Loss | ||||||||
Foreign Currency Translation Adjustment | (2,832 | ) | 5,278 | |||||
Comprehensive Loss | (1,707,158 | ) | (1,764,854 | ) | ||||
Net Loss Per Share | ||||||||
Basic and diluted | $ | (0.08 | ) | $ | (0.10 | ) | ||
Weighted Average Number of Shares Outstanding – Basic and Diluted | 21,599,118 | 18,373,355 |
Reconciliation of Cash Operating Expenses and Cash Operating Loss Before Depreciation, Amortization and Other Non-Cash Items
For the twelve months ended December 31, | ||||||||
2018 | 2017 | |||||||
GAAP Operating Expenses | (2,657,467 | ) | (2,470,400 | ) | ||||
Non-cash depreciation | 127,020 | 127,899 | ||||||
Non-cash amortization of intangible assets | 50,331 | 162,076 | ||||||
Non-cash stock-based compensation | 625,625 | 559,972 | ||||||
Impairment of assets | 307,576 | - | ||||||
Non GAAP Cash Operating Expenses | (1,546,915 | ) | (1,620,453 | ) | ||||
GAAP Operating Loss | (1,317,735 | ) | (1,312,563 | ) | ||||
Non-cash depreciation | 127,020 | 127,899 | ||||||
Non-cash amortization of intangible assets | 50,331 | 162,076 | ||||||
Non-cash stock-based compensation | 625,625 | 559,972 | ||||||
Impairment of assets | 307,576 | - | ||||||
Non GAAP Operating loss Before | ||||||||
Depreciation and Amortization | (207,183 | ) | (462,616 | ) |
Vycor Medical, Inc. contacts:
951 Broken Sound Parkway NW
Suite 320
Boca Raton, FL. 33487
(561) 558-2020
info@vycormedical.com