Skyline Medical Reports 2017 Third Quarter Financial Results

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| Source: Skyline Medical Inc.

MINNEAPOLIS, Nov. 14, 2017 (GLOBE NEWSWIRE) -- Skyline Medical Inc. (NASDAQ:SKLN) (“Skyline” or the “Company”), producer of the FDA-approved STREAMWAY® System for automated, direct-to-drain medical fluid disposal, reports financial results for the three and nine months ended September 30, 2017 and provides a business update on its plans to diversify its revenue streams to include precision medicine and the Contract Research Organization (“CRO”) services sector.

Highlights of the third quarter of 2017 and recent weeks include:

  • Initiating joint venture with Helomics Corporation, a precision diagnostic company and integrated clinical CRO, to leverage the Helomics D-CHIP™ platform to develop and market new approaches for personalized cancer diagnosis and care.
  • Initiating joint venture with CytoBioscience, a privately held biomedical company, to provide Skyline with access to CytoBioscience’ personalized research services and further expand the Company’s expertise and client base in the CRO sector.
  • Sold two STREAMWAY Systems to medical centers in the U.S.
  • Partnered with Canada-based and Switzerland-based independent distributors to drive commercial activity of the STREAMWAY in these regions
  • Partnered with Australia independent distributor, Device Technologies Australia PTY LTD, an established distributor that employs more than 600 healthcare specialists and support staff, to sell the STREAMWAY System in Australia, New Zealand, Fiji and the Pacific Islands.
  • Partnered with Intalere, a healthcare supply chain manager that empowers medical providers to better manage their spend and deliver superior care

Management Commentary

Dr. Carl Schwartz commented, “We have steadily grown our focus on sales and marketing of the STREAMWAY during the first nine months of 2017, including significantly increasing our attendance at trade shows to maximize our exposure to decision makers in the medical field. This strategy is starting to gain traction and we sold two STREAMWAY Systems in the third quarter. We also recently signed agreements with several international distributors, based in Canada, Switzerland and Australia, all of which were carefully selected based on their past track records selling medical devices to hospital and medical centers in their respective regions. These distributors are experts at identifying and selling value-added medical technologies and it is encouraging that they can easily see the value the STREAMWAY System could bring to these international markets. We are excited about this opportunity to expand into new geographies and we expect our ongoing investments in sales and marketing of the STREAMWAY system to continue to broaden our market reach.”

Dr. Schwartz continued, “To optimize the long-term stability of Skyline, we are actively looking at ways to diversify our product offering and secure additional revenue streams. We have identified the Contract Research Organization (“CRO”) services sector as a promising growth opportunity. CROs provide specialized services that are integral to the development of drugs, biologics and medical devices. With the growth of the personalized medicine market, which according to Global Market Insights Inc. is expected to reach $96 billion by 2024, it is becoming more and more evident that the role of CROs is not just to maintain efficiency and safety during clinical trials, but also to assist in the development of new approaches for personalized diagnosis and care. We are forming joint ventures with two revenue-producing companies, Helomics and CytoBioscience, which provide CRO services with a specialization in diagnostics, to allow Skyline to enter this market. Skyline is at an exciting point in its evolution, as it is in the early stages of transitioning into what is arguably one of the most revolutionary areas of the healthcare sector, and we look forward to advancing this strategy.”

Financial Results

Revenue for the three months ended September 30, 2017 was $152,535, compared with $134,605 for the three months ended September 30, 2016.  Revenue was derived from the sales of two STREAMWAY Systems and the sale of STREAMWAY disposable products during the third quarter of 2017.

Gross profit for the three months ended September 30, 2017 was $123,829 or 81.2% of revenue, relatively flat compared with $108,124 or 80.3% of revenue for the same period in 2016.

Total operating expenses for the three months ended September 30, 2017 were $1.1 million, compared with $1.2 million for the three months ended September 30, 2016.  General and Administrative expenses and operations expenses were lower, but were partially offset by higher sales and marketing expenses.

Net loss available to common shareholders for the three months ended September 30, 2017 was $992,095 or $0.16 per share on 6,232,761 weighted average shares outstanding.  This compares with a net loss available to common shareholders for the three months ended September 30, 2016 of $1.1 million or $0.32 per share on 3,320,139 weighted average shares outstanding.

The Company had cash, cash equivalents and marketable securities of $2.0 million as of September 30, 2017, compared with $2,148,419 as of December 31, 2016. 

Revenue for the nine months ended September 30, 2017 was $434,523, compared with $316,931 for the nine months ended September 30, 2016. 

Total operating expenses for the nine months ended September 30, 2017 were $5.2 million compared with $6.0 million for the nine months ended September 30, 2016.  The decline was primarily due to a $715,637 decrease in General and Administrative expenses attributed in part to a settlement with the Company's former chief executive officer in the 2016 period and a decrease of $352,595 in operations expense, partially offset by an increase in Sales and Marketing expenses of $331,548 largely due to the hiring of additional sales staff. 

Net loss available to common shareholders for the nine months ended September 30, 2017 was $4.9 million or $0.78 per share, compared with a net loss available to common shareholders for the nine months ended September 30, 2016 of $5.8 million, or $2.57 per share.

Conference Call and Webcast

Skyline management will host a conference call beginning at 11:00 a.m. Eastern time today, Wednesday, November 15, to discuss its third quarter 2017 financial results, and to answer questions about its proposed joint ventures with Helomics and CytoBioscience. 

To access the conference call, U.S.-based listeners should dial (844) 295-1034 and international listeners should dial (574) 990-1037. All listeners should provide the following passcode: 9496546

A webcast of the call will also be available on the Investors section of the Company’s website at www.skylinemedical.com.

About the STREAMWAY System

Skyline's revolutionary, FDA-cleared STREAMWAY system is the first true direct-to-drain fluid disposal system designed specifically for medical applications, such as radiology, endoscopy, urology and cystoscopy procedures. It connects directly to a facility's plumbing system to automate the collection, measurement and disposal of waste fluids. 

The STREAMWAY minimizes human intervention for better safety and improves compliance with Occupational Safety and Health Administration (OSHA) and other regulatory agency safety guidelines. It also provides unlimited capacity for increased efficiency in the operating room, which leads to greater profitability. Furthermore, the STREAMWAY eliminates canisters to reduce overhead costs and provides greater environmental stewardship by helping to eliminate the approximately 50 million potentially disease-infected canisters that go into landfills annually in the U.S.  For a demonstration please visit www.skylinemedical.com or call 855-785-8855.

About Skyline Medical

Skyline Medical 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 that 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 OSHA and other regulatory agency safety guidelines; 3) improve efficiency in the operating room, and radiology and endoscopy departments, thereby 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 each year in the U.S.  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 risks related to the proposed joint ventures with Helomics and CytoBioscience, including the need to negotiate the definitive agreements for the joint ventures; possible failure to realize anticipated benefits of the joint ventures; and costs of providing funding to the joint ventures. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; 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 and with any strategic or joint venture 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.  This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position. See the Company's most recent Annual Report on Form 10-K, and subsequent reports and other filings at www.sec.gov.

Contacts:

Skyline Medical
Carl Schwartz, Chief Executive Officer
(651) 389-4800
cschwartz@skylinemedical.com

Investors
KCSA Strategic Communications
Elizabeth Barker
(212) 896-1203
skln@kcsa.com


SKYLINE MEDICAL INC.
CONDENSED STATEMENTS OF OPERATIONS and OTHER COMPREHENSIVE INCOME
(Unaudited)
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2017   2016   2017   2016 
Revenue$152,535  $134,605  $434,523  $316,931 
        
Cost of goods sold 28,706   26,481   87,709   149,130 
        
Gross margin 123,829   108,124   346,814   167,801 
        
General and administrative expense 621,716   733,074   3,968,493   4,684,130 
        
Operations expense 192,536   292,856   575,467   928,062 
        
Sales and marketing expense 301,672   137,784   680,396   348,848 
        
Interest expense -   3   -   3 
        
Total Expense 1,115,924   1,163,717   5,224,356   5,961,043 
        
Net loss available to common shareholders (992,095)  (1,055,593)  (4,877,542)  (5,793,242)
        
Other comprehensive gain       
Unrealized gain from marketable securities -   (1,299)  -   4,579 
        
Comprehensive (loss)$(992,095) $(1,056,892) $(4,877,542) $(5,788,663)
        
Loss per common share - basic and diluted$(0.16) $(0.32) $(0.78) $(2.57)
        
Weighted average shares used in computation - basic and diluted 6,232,761   3,320,139   6,283,567   2,250,315 


SKYLINE MEDICAL INC.
CONDENSED BALANCE SHEETS
(Unaudited)
 
  September 30, 2017 December 31, 2016
         
Current Assets:        
Cash and Cash Equivalents $765,704  $1,764,090 
Certificates of Deposit  1,224,728   100,000 
Marketable Securities  -   284,329 
Accounts Receivable  91,708   38,919 
Notes Receivable (Note 3)  785,000   - 
Inventories  238,889   272,208 
Prepaid Expense and other assets  196,825   148,637 
Total Current Assets  3,302,854   2,608,183 
         
Fixed Assets, net  99,982   101,496 
Intangibles, net  96,501   97,867 
         
Total Assets $3,499,337  $2,807,546 
         
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:        
Accounts Payable $74,642  $220,112 
Accrued Expenses  1,132,613   1,346,105 
Deferred Revenue  10,185   7,998 
Total Current Liabilities  1,217,440   1,574,215 
         
Accrued Expenses  -   309,649 
Total Liabilities  1,217,440   1,883,864 
Commitments and Contingencies  -   - 
Stockholders’ Equity:        
Series B Convertible Preferred Stock, $.01 par value, 20,000,000 authorized, 79,246 and 79,246 outstanding  792   792 
Common Stock, $.01 par value, 24,000,000 authorized, 6,232,761 and 4,564,428 outstanding  62,327   45,644 
Additional paid-in capital  54,114,771   47,894,196 
Accumulated Deficit  (51,895,993)  (47,018,451)
Accumulated Other Comprehensive Income  -   1,501 
Total Stockholders' Equity  2,281,897   923,682 
         
Total Liabilities and Stockholders' Equity $3,499,337  $2,807,546