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): November 16, 2015
Skyline Medical Inc.
(Exact name of Registrant as Specified in its Charter)
| Delaware | 001-36790 | 33-1007393 |
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
| 2915 Commers Drive, Suite 900 Eagan, Minnesota |
55121 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
Registrant's telephone number, including area code: (651) 389-4800
Former Name or Former Address, if Changed Since Last Report: Not Applicable
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 (see General Instruction A.2. below):
| ☐ | 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)) |
Item 2.02 Results of Operations and Financial Condition.
On November 16, 2015, Skyline Medical Inc. issued a press release announcing its third quarter 2015 financial results. A copy of the press release is furnished as Exhibit 99.1 to this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description/Exhibit |
| 99.1 | Press Release of Skyline Medical Inc. dated November 16, 2015 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| By: | /s/ Josh Kornberg | ||
Name: Josh Kornberg Title: President and Chief Executive Officer | |||
Date: November 16, 2015
Exhibit 99.1
Skyline Announces Third Quarter 2015 Results
Implementing Sales and Marketing Expansion Following Capital Raise in August
MINNEAPOLIS, MN – November 16, 2015 – Skyline Medical Inc. (NASDAQ: SKLN, SKLNU), producer of the FDA-approved STREAMWAY System for automated, direct-to-drain medical fluid disposal, today reported its financial results for the three month period ended September 30, 2015.
Josh Kornberg, CEO of Skyline, commented, “We have been focused on positioning the STREAMWAY System as the premium waste fluid disposal system in the market by targeting respected and large healthcare facilities throughout the country. During 2015, we successfully installed STREAMWAY Systems at Beth Israel Hospital, Dartmouth – Hitchcock Medical Center, VA Medical Center, Penn State Hershey Medical Center and Duke University Health System, among other notable facilities. We believe that having these facilities as active customers will be key to our success as we begin deploying our capital to build a national sales and marketing team to meet the strong demand for our flagship product and position us for rapid growth in 2016.
“The adoption of the STREAMWAY System has outpaced our expectations since we launched our next generation technology last year. We currently have 12 new STREAMWAY trials in process at U.S. medical clinics and over 100 installations throughout the U.S.,” continued Mr. Kornberg.
“Our success selling to major hospitals indicates that medical centers are shifting away from, and we are displacing, alternative fluid management solutions that have been in place for many years. For us to have achieved this, despite our limited sales and marketing capabilities, truly validates the quality and effectiveness of the STREAMWAY™ System. The STREAMWAY is currently installed in a wide variety of procedure rooms, including surgery, interventional radiology and endoscopy suites, demonstrating very significant market potential for the product. Moreover, we are starting to see repeat orders from some of these customers.
“The recent capital raise, combined with careful management of the Company’s burn rate and high margins, should allow us to fund future growth for the foreseeable future. Looking ahead, we are exploring strategic joint ventures for distribution, and we believe there may be attractive opportunities for accretive acquisitions. We are also in the process of launching our global expansion strategy and are excited to have filed for international patents in Canada and select European countries, which are major potential markets for our technologies,” concluded Mr. Kornberg.
Recent Operational Highlights:
| · | 12 new STREAMWAY trials in process at U.S. medical clinics; |
| · | 15 STREAMWAY units sold and shipped in first nine months of 2015; |
| · | Significantly expanding sales and marketing for the STREAMWAY System; expected to drive sales starting in early 2016 |
| · | International expansion underway with filing of patents in Canada and select European countries; |
| · | NASDAQ listing and capital raise in August 2015 to create liquidity and value for security holders; |
Operational Overview
Skyline Medical currently has 12 ongoing trials of the STREAMWAY® System across eight different states in the U.S. These trials are taking place in a range of different medical facilities including hospitals and surgery centers. The trial periods are offered as a way for the facilities to validate the STREAMWAY on a small scale, prior to purchasing the trialed units and ultimately rolling out standardized fluid waste management systems across the whole facility.
The Company recently announced that it is also in the process of filing international patent applications for the technologies and processes applied in the STREAMWAY® System. The initial applications are being applied for in Canada and select European countries to advance the Company’s strategy to commence commercial activities in major international markets. The patents are for a direct-to-drain fluid waste disposal system that has continuous suction and unlimited capacity.
Subsequent to the quarter end, the Company presented at the Outpatient Surgery Magazine's OR Excellence 2015 Trade Show in San Antonio, Texas.
Financial Overview
Revenues for the third quarter of 2015 were $85,792, compared to $397,254 for the same period in 2014. Gross profit for the third quarter of 2015 was $66,019, or 77%, compared to $262,528 for the same period in 2014.
Net loss for the period was $1.1 million or $0.28 per basic and diluted share, compared to a net loss of $1.1 million, or $0.37 per basic and diluted share, in the comparable period in 2014.
The Company strengthened its balance sheet in August with the successful completion of a capital raise and concurrent listing of its common stock and units on the NASDAQ Capital Market. The Company reported $7.7 million in cash as of September 30, 2015.
About Skyline Medical Inc.
Skyline Medical Inc. produces a fully automated, patented, FDA-cleared, waste fluid disposal system that virtually eliminates staff exposure to blood, irrigation fluid and other potentially infectious fluids found in the healthcare environment. Antiquated manual fluid handling methods — which require hand carrying and emptying filled fluid canisters — present an exposure risk and potential liability. Skyline Medical's STREAMWAY System fully automates the collection, measurement and disposal of waste fluids and is designed to: 1) reduce overhead costs to hospitals and surgical centers, 2) improve compliance with Occupational State and Health Association (OSHA) and other regulatory agency safety guidelines, 3) improve efficiency in the operating room, and radiology and endoscopy departments — leading to greater profitability, and 4) provide greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the United States. For additional information, please visit: www.skylinemedical.com.
Forward-looking Statements:
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include, among other things, current negative operating cash flows and a significant balance of debts, liabilities and cash obligations that are either considered past due or that will become due in calendar 2015; the terms of any further financing, which may be highly dilutive and may include onerous terms; the features of the Company’s Series A Warrants that include a cashless exercise feature that has the potential to be highly dilutive, and the existence of which may depress the price of our common stock regardless of the Company’s business performance; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance, if our product is not accepted by our potential customers, it is unlikely that we will ever become profitable, adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, which are available for review at www.sec.gov. See the Company's most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.
Contact:
Skyline Investor Relations Contacts:
Garth Russell
KCSA Strategic Communications
212-896-1250
skyline@kcsa.com
SOURCE: Skyline Medical Inc.
Financial Tables Below
SKYLINE MEDICAL INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenue | $ | 85,792 | $ | 397,254 | $ | 471,078 | $ | 785,767 | ||||||||
| Cost of goods sold | 19,773 | 134,726 | 199,307 | 264,174 | ||||||||||||
| Gross Margin | 66,019 | 262,528 | 271,771 | 521,593 | ||||||||||||
| General and administrative expense | 861,098 | 737,519 | 1,589,522 | 3,247,024 | ||||||||||||
| Operations expense | 202,799 | 183,154 | 375,429 | 740,012 | ||||||||||||
| Sales and marketing expense | 66,720 | 325,141 | 439,703 | 849,364 | ||||||||||||
| Interest expense | 51,804 | 131,935 | 394,641 | 164,962 | ||||||||||||
| Gain on valuation of equity-linked financial instruments | - | - | - | (11,599 | ) | |||||||||||
| Total expense | 1,182,421 | 1,377,749 | 2,799,295 | 4,989,763 | ||||||||||||
| Net loss available to common shareholders | $ | (1,116,402 | ) | $ | (1,115,221 | ) | $ | (2,527,524 | ) | $ | (4,468,170 | ) | ||||
| Loss per common share basic and diluted | $ | (0.28 | ) | $ | (0.37 | ) | $ | (0.74 | ) | $ | (1.51 | ) | ||||
| Weighted average shares used in computation, basic and diluted | 3,936,126 | 2,984,335 | 3,435,700 | 2,967,483 | ||||||||||||
SKYLINE MEDICAL INC.
CONDENSED BALANCE SHEETS
(Unaudited)
| September
30, 2015 | December
31, 2014 | |||||||
| Current Assets: | ||||||||
| Cash | $ | 7,733,097 | $ | 16,384 | ||||
| Accounts Receivable | 14,196 | 57,549 | ||||||
| Inventories | 236,890 | 367,367 | ||||||
| Prepaid Expense and other assets | 213,223 | 190,015 | ||||||
| Total Current Assets | 8,197,406 | 631,315 | ||||||
| Fixed Assets, net | 126,570 | 196,479 | ||||||
| Intangibles, net | 92,402 | 73,183 | ||||||
| Total Assets | $ | 8,416,378 | $ | 900,977 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT) | ||||||||
| Current Liabilities: | ||||||||
| Accounts Payable | 1,138,512 | 2,194,518 | ||||||
| Accrued Expenses | 1,434,412 | 3,066,379 | ||||||
| Short-term notes payable net of discounts of $0 and $194,097 (See Note 4) | - | 937,424 | ||||||
| Deferred Revenue | 29,180 | 5,000 | ||||||
| Total Current Liabilities | 2,602,104 | 6,203,321 | ||||||
| Accrued Expenses | - | 213,883 | ||||||
| Total Liabilities | $ | 2,602,104 | $ | 6,417,204 | ||||
| Commitments and Contingencies | - | - | ||||||
| Stockholders’ Equity/(Deficit): | ||||||||
| Series A Convertible Preferred Stock, $.01 par value, $100 Stated Value, 20,000,000 authorized, 0 and 20,550 outstanding | - | 206 | ||||||
| Series B Convertible Preferred Stock, $.01 par value, 10,000,000 authorized, 1,895,010 and 0 outstanding | 18,950 | - | ||||||
| Common Stock, $.01 par value, 100,000,000 authorized, 5,203,428 and 3,092,766 outstanding | 52,033 | 30,927 | ||||||
| Additional paid-in capital | 43,972,722 | 30,093,745 | ||||||
| Accumulated Deficit | (38,229,431 | ) | (35,641,105 | ) | ||||
| Total Stockholders’ Equity/(Deficit) | 5,814,274 | (5,516,227 | ) | |||||
| Total Liabilities and Stockholders’ Equity/(Deficit) | $ | 8,416,378 | $ | 900,977 | ||||