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Note 1 - Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2017
Notes to Financial Statements  
Significant Accounting Policies [Text Block]
NOTE
1
— SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 
Nature of Operations and Continuance of Operations
 
Skyline Medical Inc. (the "Company") was incorporated under the laws of the State of Minnesota in
2002.
Effective
August 6, 2013,
the Company changed its name to Skyline Medical Inc. As of
June 30, 2017,
the registrant had
6,189,428
shares of common stock, par value
$.01
per share, outstanding, adjusted for a
1
-for-
25
reverse stock split effective
October 27, 2016.
In this Report, all numbers of shares and per share amounts, as appropriate, have been stated to reflect the reverse stock split. Pursuant to an Agreement and Plan of Merger dated effective
December 16, 2013,
the Company merged with and into a Delaware corporation with the same name that was its wholly-owned subsidiary, with such Delaware corporation as the surviving corporation of the merger. The Company has developed an environmentally safe system for the collection and disposal of infectious fluids that result from surgical procedures and post-operative care. The Company also makes ongoing sales of our proprietary cleaning fluid and filters to users of our systems. In
April 2009,
the Company received
510
(k) clearance from the FDA to authorize the Company to market and sell its STREAMWAY® SYSTEM products.
 
The accompanying financial statements have been prepared assuming the Company will continue as a going concern. The Company has suffered recurring losses from operations and had a stockholders’ deficit until
August 31, 2015
whereupon the Company closed its public offering of units consisting of common stock, Series B Convertible Preferred Stock and Series A Warrants (the “Units”). There remains though, substantial doubt about its ability to continue as a going concern. The financial statements do
not
include any adjustments that might result from the outcome of this uncertainty.
  
Since inception to
June 30, 2017,
the Company raised approximately
$27,765,934
in equity, inclusive of
$2,055,000
from a private placement of Series A Convertible Preferred Stock,
$13,555,003
from the public offering of Units completed in
2015,
$1,739,770
from a registered direct offering completed in
2016,
$3,421,188
from the public offering of Units completed in the
first
quarter of
2017,
$358,312
from the underwriter exercising their option to purchase up to
175,000
additional shares of common stock and to acquire additional warrants to purchase up to
35,000
additional shares of common stock, and
$5,685,000
in debt financing. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources.”
 
Recent Accounting Developments
 
In
May 2014,
the Financial Accounting Standards Board (“FASB”) issued ASU
2014
-
09,
Revenue from Contracts with Customers
and created a new topic in the FASB Accounting Standards Codification ("ASC"), Topic
606,
and has since amended the standard with ASU
2015
-
14,
“Revenue from Contracts with Customers: Principal versus Agent Considerations (Reporting Revenue Gross versus Net),”
ASU
2016
-
10,
“Revenue from Contracts with Customers: Identifying Performance Obligations and Licensing,”
and ASU
2016
-
12,
“Revenue from Contracts with Customers: Narrow-Scope Improvements and Practical Expedients.”
These new standards provide a single comprehensive revenue recognition framework for all entities and supersede nearly all existing U.S. GAAP revenue recognition guidance, including industry-specific guidance. The core principle of the revenue model is that an entity should recognize revenue in a manner that depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard is designed to create greater comparability for financial statement users across industries and also requires enhanced disclosures. The amendments are effective for annual reporting periods beginning after
December 15, 2017,
including interim periods within that reporting period. Early application is
not
permitted. The FASB allows
two
adoption methods under ASC
606.
We currently plan to adopt the standard using the “modified retrospective method.” Under that method, we will apply the rules to all contracts existing as of
January 1, 2018,
recognizing in the beginning retained earnings an adjustment for the cumulative effect of the change and providing additional disclosure comparing results to previous accounting standards. Upon initial evaluation, we believe the requirements of this standard will
not
result in a significant change to our results.
 
In
June 2014,
the FASB issued ASU
2014
-
12,
"Compensation - Stock Compensation"
providing explicit guidance on how to account for share-based payments granted to employees in which the terms of the award provide that a performance target that affects vesting could be achieved after the requisite service period. The amendments in this update are effective.
 
In
August 2014,
the FASB issued ASU
2014
-
15,
Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern
. The new standard requires management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. The standard is effective for public entities for annual and interim periods beginning after
December 15, 2016,
with early adoption permitted. We implemented in the
first
quarter of
2017.
 
In
April 2015,
the FASB issued ASU
2015
-
03,
Simplifying the Presentation of Debt Issuance Costs
. Debt issuance costs related to a recognized debt liability will be presented on the balance sheet as a direct deduction from the debt liability, similar to the presentation of debt discounts, rather than as an asset. Amortization of these costs will continue to be reported as interest expense. ASU
2015
-
03
is effective.
 
In
July 2015,
the FASB issued ASU
No.
 
2015
-
11
, Inventory (Topic
330
): Simplifying the Measurement of Inventory
, requiring that inventory be measured at the lower of cost and net realizable value. Net realizable value is defined as estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. This ASU is effective within annual periods beginning on or after
December 
15,
2016,
including interim periods within that reporting period. This ASU is implemented.
 
In
November 2015,
the FASB issued ASU
2015
-
17,
“Income Taxes (Topic
740
)”
providing guidance on the balance sheet classification of deferred taxes. The guidance requires that deferred tax assets and liabilities to be classified as noncurrent in the Balance Sheet. The guidance is effective for fiscal years beginning after
December 15, 2016
and for interim periods within those fiscal years, with early adoption permitted. This ASU is implemented.
 
In
January 2016,
the FASB issued ASU
No.
2016
-
01,
“Financial Instruments-Overall (Subtopic
825
-
10
): Recognition and Measurement of Financial Assets and Financial Liabilities”
(“ASU
2016
-
01”
). The standard changes how entities measure certain equity investments and present changes in the fair value of financial liabilities measured under the fair value option that are attributable to their own credit. Under the new guidance, entities will be required to measure equity investments that do
not
result in consolidation and are
not
accounted for under the equity method at fair value and recognize any changes in fair value in net income unless the investments qualify for the new practicability exception. The standard is effective for fiscal years beginning after
December 15, 2017,
including interim periods within those fiscal years. The Company does
not
believe that the adoption of this guidance will have a material impact on the Company’s financial statements and disclosures.
 
In
February 2016,
the FASB issued ASU
No.
2016
-
02,
Leases (Topic
842
)
” (“ASU
2016
-
02”
), which requires lessees to put most leases on their balance sheets but recognize the expenses on their income statements in a manner similar to current practice. The standard states that a lessee would recognize a lease liability for the obligation to make lease payments and a right-to-use asset for the right to use the underlying asset for the lease term. The standard is effective for fiscal years and interim periods within those fiscal years beginning after
December 15, 2018.
Early adoption is permitted. We are currently evaluating the timing of our adoption and the impact that the updated standard will have on our financial statements.
 
In
March 2016,
the FASB issued ASU
No.
2016
-
09,
Compensation - Stock Compensation (Topic
718
): Improvements to Employee Share-Based Payment Accountin
g” (“ASU
2016
-
09”
). ASU
2016
-
09
simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The standard is effective for fiscal years and interim periods within those fiscal years beginning after
December 15, 2016.
Early adoption is permitted. This ASU is implemented.
 
During
August 2016,
the FASB issued ASU
No.
2016
-
15,
“Statement of Cash Flows (Topic
230
): Classification of Certain Cash Receipts and Cash Payments”,
to address diversity in how certain cash receipts and cash payments are presented and classified in the statements of cash flows. The amendments are effective for public business entities for fiscal years beginning after
December 15, 2017,
and interim periods within those fiscal years. The amendments should be applied using a retrospective transition method to each period presented. If retrospective application is impractical for some of the issues addressed by the update, the amendments for those issues would be applied prospectively as of the earliest date practicable. Early adoption is permitted, including adoption in an interim period. The Company does
not
expect the adoption of ASU
2016
-
15
to have a material impact on its financial statements.
 
We reviewed all other significant newly issued accounting pronouncements and determined they are either
not
applicable to our business or that
no
material effect is expected on our financial position and results of our operations.
 
Valuation of Intangible Assets
 
We review identifiable intangible assets for impairment in accordance with ASC
350
— Intangibles —Goodwill and Other, whenever events or changes in circumstances indicate the carrying amount
may
not
be recoverable. Our intangible assets are currently solely the costs of obtaining trademarks and patents. Events or changes in circumstances that indicate the carrying amount
may
not
be recoverable include, but are
not
limited to, a significant change in the medical device marketplace and a significant adverse change in the business climate in which we operate. If such events or changes in circumstances are present, the undiscounted cash flows method is used to determine whether the intangible asset is impaired. Cash flows would include the estimated terminal value of the asset and exclude any interest charges. If the carrying value of the asset exceeds the undiscounted cash flows over the estimated remaining life of the asset, the asset is considered impaired, and the impairment is measured by reducing the carrying value of the asset to its fair value using the discounted cash flows method. The discount rate utilized is based on management’s best estimate of the related risks and return at the time the impairment assessment is made.
 
Accounting Policies and Estimates
 
The presentation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
 
Presentation of Taxes Collected from Customers
 
Sales taxes are imposed on the Company’s sales to nonexempt customers. The Company collects the taxes from customers and remits the entire amounts to the governmental authorities. The Company’s accounting policy is to exclude the taxes collected and remitted from revenues and expenses.
 
Shipping and Handling
 
Shipping and handling charges billed to customers are recorded as revenue. Shipping and handling costs are recorded within cost of goods sold on the statement of operations.
 
Advertising
 
Advertising costs are expensed as incurred. Advertising expenses were
$17,409
and
$21,680
in the
three
and
six
months ended
June 30, 2017
and were
$42,665
and
$46,662
in the
three
and
six
months ended
June 30, 2016,
respectively.
 
Research and Development
 
Research and development costs are charged to operations as incurred. Research and development expenses were
$69,987
and
$154,459
in the
three
and
six
months ended
June 30, 2017
and were
$100,234
and
$222,395
in the
three
and
six
months ended
June 30, 2016,
respectively.
 
Revenue Recognition
 
The Company recognizes revenue in accordance with the SEC’s Staff Accounting Bulletin Topic
13
Revenue Recognition and ASC
605
-Revenue Recognition.
 
Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred, the fee is fixed and determinable and collectability is probable. Delivery is considered to have occurred upon either shipment of the product or arrival at its destination based on the shipping terms of the transaction. The Company’s standard terms specify that shipment is FOB Skyline and the Company will, therefore, recognize revenue upon shipment in most cases. This revenue recognition policy applies to shipments of the STREAMWAY SYSTEM units as well as shipments of filters and fluids. When these conditions are satisfied, the Company recognizes gross product revenue, which is the price it charges generally to its customers for a particular product. Under the Company’s standard terms and conditions, there is
no
provision for installation or acceptance of the product to take place prior to the obligation of the customer. The customer’s right of return is limited only to the Company’s standard
one
-year warranty whereby the Company replaces or repairs, at its option, and it would be rare that the STREAMWAY SYSTEM unit or significant quantities of cleaning solution or filters
may
be returned. Additionally, since the Company buys the STREAMWAY SYSTEM units, cleaning solution and filters from “turnkey” suppliers, the Company would have the right to replacements from the suppliers if this situation should occur.
 
Cash Equivalents
 
The Company considers all highly liquid debt instruments with a maturity of
three
months or less when purchased to be cash equivalents. Cash equivalents are stated at cost, which approximates fair value.
 
Certificates of Deposit
 
Short-term interest bearing investments are those with maturities of less than
one
year but greater than
three
months when purchased. Certificates with maturity dates beyond
one
year are classified as noncurrent assets. These investments are readily convertible to cash and are stated at cost plus accrued interest, which approximates fair value.
 
Investment Securities
 
Readily marketable investments in debt and equity securities are classified as available-for-sale and are reported at fair value with unrealized gains and losses recorded in other comprehensive income. Unrealized gains are charged to earnings when an incline in fair value above the cost basis is determined to be other-than-temporary. Realized gains and losses on dispositions are based on the net proceeds and the adjusted book value of the securities sold, using the specific identification method.
 
Fair Value Measurements
 
Under generally accepted accounting principles as outlined in the Financial Accounting Standards Board’s
Accounting Standards Codification
(ASC)
820,
fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The accounting standards ASC
820
establishes a
three
-level fair value hierarchy that prioritizes information used in developing assumptions when pricing an asset or liability as follows:
 
Level
1
– Observable inputs such as quoted prices in active markets;
 
Level
2
– Inputs other than quoted prices in active markets, that are observable either directly or indirectly; and
 
Level
3
– Unobservable inputs where there is little or
no
market data, which requires the reporting entity to develop its own assumptions.
 
The Company uses observable market data, when available, in making fair value measurements. Fair value measurements are classified according to the lowest level input that is significant to the valuation.
 
The fair value of the Company’s investment securities was determined based on Level
1
inputs.
 
Receivables
 
Receivables are reported at the amount the Company expects to collect on balances outstanding. The Company provides for probable uncollectible amounts through charges to earnings and credits to the valuation based on management’s assessment of the current status of individual accounts, changes to the valuation allowance have
not
been material to the financial statements.
 
Inventories
 
Inventories are stated at the lower of cost or market, with cost determined on a
first
-in,
first
-out basis. Inventory balances are as follows:
 
    June 30, 2017   December 31, 2016
         
Finished goods   $
28,923
    $
38,201
 
Raw materials    
161,833
     
165,812
 
Work-In-Process    
51,448
     
68,195
 
Total   $
242,204
    $
272,208
 
 
Property and Equipment
 
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the respective assets. Estimated useful asset life by classification is as follows:
 
    Years
Computers and office equipment    
3
 
-
 
7
 
Leasehold improvements    
 
 
5
 
 
 
Manufacturing tooling    
3
 
-
 
7
 
Demo Equipment    
 
 
3
 
 
 
 
The Company’s investment in Fixed Assets consists of the following:
 
    June 30, 2017   December 31, 2016
Computers and office equipment   $
177,641
    $
164,318
 
Leasehold improvements    
25,635
     
25,635
 
Manufacturing tooling    
107,955
     
103,204
 
Demo equipment    
43,798
     
23,236
 
Total    
355,029
     
316,393
 
Less: Accumulated depreciation    
245,100
     
214,897
 
Total Fixed Assets, Net   $
109,929
    $
101,496
 
 
Upon retirement or sale, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations. Maintenance and repairs are charged to operations as incurred.
 
Depreciation expense was
$14,519
and
$30,204
in the
three
and
six
months ended
June 30, 2017,
and was
$19,212
and
$38,420
for the
three
and
six
months ended
June 30, 2016,
respectively.
 
Intangible Assets
 
Intangible assets consist of trademarks and patent costs. Amortization expense was
$2,902
and
$5,790
in the
three
and
six
months ended
June 30, 2017,
and was
$1,878
and
$3,710
in the
three
and
six
months ended
June 30, 2016,
respectively. The assets are reviewed for impairment annually, and impairment losses, if any, are charged to operations when identified.
 
Income Taxes
 
The Company accounts for income taxes in accordance with ASC
740
- Income Taxes (“ASC
740”
). Under ASC
740,
deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to impact taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
 
There is
no
income tax provision in the accompanying statements of operations due to the cumulative operating losses that indicate a
100%
valuation allowance for the deferred tax assets and state income taxes is appropriate.
 
The Company reviews income tax positions expected to be taken in income tax returns to determine if there are any income tax uncertainties. The Company recognizes tax benefits from uncertain tax positions only if it is more likely than
not
that the tax positions will be sustained on examination by taxing authorities, based on technical merits of the positions. The Company has identified
no
income tax uncertainties.
 
Tax years subsequent to
2013
remain open to examination by federal and state tax authorities.
 
Summary of Significant Accounting Policies
 
In
March 2016,
the FASB issued ASU
2016
-
09,
“improvements to Employee Share-Based Payment Accounting,” which requires companies to recognize additional tax benefits or expenses related to the vesting or settlement of employee share based awards as income tax provision or benefit in the income statement in the reporting period in which they occur. In addition, ASU
2016
-
09
requires that all tax related cash flows resulting from share-based payments, including the excess tax benefits related to settlement of stock-based awards, be classified as cash flows from operating activities in the statement of cash flows. The new standard is effective for annual reporting periods beginning after
December 15, 2016,
with early adoption permitted. The Company did
not
elect to early adopt ASU
2016
-
09,
but rather adopted the guidance in the
first
quarter of
2017.
 
The adoption of ASU
2016
-
09
required
no
retrospective adjustments to the financial statements. In addition, there was
no
material cumulative-effect adjustment to retained earnings, nor did the adoption impact the tax provision for the prior or current quarter.
 
Income Tax Balance Sheet Classification
 
In
November 2015,
the FASB issued ASU
2015
-
17,
“Income Taxes (Topic
740
)” providing guidance on the balance sheet classification of deferred taxes. The guidance requires that deferred tax assets and liabilities to be classified as noncurrent in the Balance Sheet. The guidance is effective for fiscal years beginning after
December 15, 2016
with early adoption permitted. The Company adopted ASU
2015
-
17
in the
first
quarter of
2017
on a prospective basis and therefore prior periods were
not
retrospectively adjusted.
 
Patents and Intellectual Property
 
On
January
25th,
2014,
the Company filed a non-provisional PCT Application
No.
PCT/US2014/013081
claiming priority from the U.S. Provisional Patent Application, number
61756763
which was filed
one
year earlier on
January
25th,
2013.
The Patent Cooperation Treaty (“PCT”) allows an applicant to file a single patent application to seek patent protection for an invention simultaneously in each of the
148
countries of the PCT, including the United States. By filing this single “international” patent application through the PCT, it is easier and more cost effective than filing separate applications directly with each national or regional patent office in which patent protection is desired.
 
Our PCT patent application is for the enhanced model of the surgical fluid waste management system. We obtained a favorable International Search Report from the PCT searching authority indicating that the claims in our PCT application are patentable (i.e., novel and non-obvious) over the cited prior art. A feature claimed in the PCT application is the ability to maintain continuous suction to the surgical field while measuring, recording and evacuating fluid to the facilities sewer drainage system. This provides for continuous operation of the STREAMWAY System unit in suctioning waste fluids, which means that suction is
not
interrupted during a surgical operation, for example, to empty a fluid collection container or otherwise dispose of the collected fluid.
 
The Company holds the following granted patents in the United States and a pending application in the United States on its earlier models:
US7469727,
US8123731
and U.S. Publication
No.
US20090216205
(collectively, the “Patents”). These Patents will begin to expire on
August 8, 2023.
 
In
July 2015,
Skyline Medical filed an international patent application for its fluid waste collection system and received a favorable determination by the International Searching Authority finding that all of the claims satisfy the requirements for novelty, inventive step and industrial applicability.  Skyline anticipates that the favorable International Search Report will result in allowance of its other various national applications.
 
Credit Risk
 
Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash. The Company places its cash with high credit quality financial institutions and, by policy, generally limits the amount of credit exposure to any
one
financial institution. The Company has a credit risk concentration because of depositing
$0.9
million of funds in excess of insurance limits in a single bank.
 
Product Warranty Costs
 
In the
three
and
six
months ending
June 30, 2017,
the Company incurred approximately
$668
and
$5,012
in current warranty costs and incurred
$1,092
and
$30,981
in warranty costs for the
three
and
six
months ending
June 30, 2016,
respectively.
 
Segments
 
The Company operates in
two
segments for the sale of its medical device and consumable products. Predominantly most of the Company’s assets, revenues, and expenses for the
three
and
six
months ending
June 30, 2017
and for
2016
in entirety were located at or derived from operations in the United States. The Company completed its
first
sale outside of the United States, in Canada, in
March 2017.
 
Risks and Uncertainties
 
The Company is subject to risks common to companies in the medical device industry, including, but
not
limited to, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, and compliance with regulations of the FDA and other governmental agencies.
 
Interim Financial Statements
 
The Company has prepared the unaudited interim financial statements and related unaudited financial information in the footnotes in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. These interim financial statements reflect all adjustments consisting of normal recurring accruals, which, in the opinion of management, are necessary to present fairly the Company’s financial position, the results of its operations and its cash flows for the interim periods. These interim financial statements should be read in conjunction with the annual financial statements and the notes thereto contained in the Form
10
-K filed with the SEC on
March 15, 2017.
The nature of the Company’s business is such that the results of any interim period
may
not
be indicative of the results to be expected for the entire year.