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 MedicalCarl Schwartz, Chief Executive
Officer(651) 389-4800cschwartz@skylinemedical.com
Investors KCSA Strategic CommunicationsElizabeth 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 |
|
|
|
|
|
|
|
|
|
|
Precision Therapeutics Inc. (NASDAQ:AIPT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Precision Therapeutics Inc. (NASDAQ:AIPT)
Historical Stock Chart
From Sep 2023 to Sep 2024