TIDMAKR
RNS Number : 8172X
Akers Biosciences, Inc.
15 August 2018
August 15, 2018
This announcement contains inside information
Akers Biosciences, Inc.
Financial Results for the Three Months and Six Months Ended June
30, 2018
Akers Biosciences, Inc. (NASDAQ: AKER) (AIM: AKR.L), ("Akers
Bio" or the "Company"), a developer of rapid health information
technologies, reports its financial results for the three months
and six months ended June 30, 2018. A Form 10-Q containing the full
financial statements is available for viewing on the Company's
website at www.akersbio.com or www.sec.gov.
Q2 & H1 Financial Summary:
-- Q2 total revenue $526,601 (Q2 2017: $1,072,861)
o Revenue from flagship PIFA Heparin PF/4 Rapid Assay products
decreased by 17% to $356,082 (Q2 2017: $426,747), but increased by
37% against the first quarter of 2018 - the Company continued to
experience lower yields in the process of extracting the antigen
used to produce these products during Q2, resulting in production
under target levels, and backorders
o Revenue from breathalyzer product sales utilizing MPC
Biosensor technology increased by 53% to $106,680 (Q2 2017:
69,848), driven by sales of Metron, a disposable ketones breath
test, and BreathScan Alcohol tests
-- H1 total revenue $829,076 (H1 2017: $1,740,111)
o Revenue from flagship PIFA Heparin PF/4 Rapid Assay products
decreased by 38% to $616,066 (H1 2017: $987,668)
o Revenue from breathalyzer product sales utilizing MPC
Biosensor technology decreased by 19% to $125,630 (H1 2017:
$155,507)
-- Q2 gross profit margin reduced to 42% (Q2 2017: 73%),
principally on account of the decline in revenue against a base of
certain fixed costs within product cost of sales, but was a
significant improvement on the first quarter of 2018
-- H1 gross profit margin was 28% (H1 2017: 68%)
-- Q2 overall expenses increased by 47%
o Administrative expenses increased by 89% to $1,565,602 (Q2
2017: $829,929)
o Sales and Marketing expenses increased by 13% to $469,469 (Q2
2017: $416,391)
o Research and Development expenses decreased by 17% to $259,124
(Q2 2017: $313,835)
-- H1 overall expenses increased by 26%
o Administrative expenses increased by 53% to $2,481,134 (H1
2017: $1,620,457)
o Sales and Marketing expenses decreased by 4% to $969,620 (H1
2017: $1,005,326)
o Research and Development expenses increased by 6% to $699,094
(H1 2017: $662,277)
-- Q2 net loss attributable to shareholders $2,067,453 (Q2 2017: $818,008)
-- H1 net loss attributable to shareholders $3,927,444 (H1 2017: $2,167,279)
-- Cash and marketable securities at June 30, 2018 of $8,753,538
(31 December 2017: $5,450,039)
Q2 & H1 Operational Summary:
-- Significant expansion of outsourced US sales and marketing
capabilities for PIFA Heparin/PF4 Rapid Assay products through
independent sales representatives (ISRs). Since the start of 2018,
Akers Bio has developed coverage through ISRs in 39 of the 50
United States, covering more than 75 per cent of the country's
total population
-- In May 2018, after extensive review internally and with the
FDA, the Company withdrew its initial 510(k) application for the
PIFA Chlamydia rapid assay - Company currently evaluating the
feasibility and marketability of this product in order to determine
when and if the 510(k) application will be resubmitted
-- Entered into a three-year National Distribution Agreement
with Diagnostica Stago, Inc. ("Stago") for the sale of PIFA Heparin
PF/4 Rapid Assay products across the US - Stago is a global leader
in hemostasis, with an extensive US-based team dedicated to the
sale and support of hemostasis products and equipment to hospitals
across the country
-- During the periods, the Company experienced lower yields in
the process of extracting antigen from the supplier provided
platelets used to produce PIFA Heparin PF/4 Rapid Assay products.
At these yield levels, production of this product was under target
levels, resulting in backorders. The Company's engineers and
supplier representatives have been working together to adjust
processes in order to restore the yield to appropriate levels, the
results of which are not yet determined
John J. Gormally, Chief Executive Officer, commented:
"Despite the manufacturing challenges associated with lower
antigen yields experienced in the production of our core PIFA
Heparin/PF4 Rapid Assay products during the quarter, demand and
interest in these tests remains robust. The Company's
relationship-building initiatives with our partners is beginning to
deliver a measurable increase in product trials and adoptions. The
antigen yield levels are improving in the current quarter and
backorders are being filled.
"Significant efforts have been made in recent months to expand
our outsourced marketing capabilities for PIFA Heparin/PF4 Rapid
Assay products through independent sales representatives (ISRs)
with relevant relationships, particularly among prospective
clinical end-users of these tests, including surgeons. In fact,
since the start of 2018, Akers Bio has developed coverage through
ISRs in 39 of the 50 United States, covering more than 75 per cent
of the country's total population.
"Following the recent review of the scientific feasibility and
marketability of products within our development pipeline, we
continue R&D activities for our more focused new product
development pipeline. This includes PIFA PLUSS Chlamydia Rapid
Assay, for which we are continuing to evaluate feasibility and
marketability in order to determine when and if the 510(k)
application will be resubmitted; as well as BreathScan KetoChek, an
Akers Wellness product for nutritional ketosis.
"Our primary commercial focus is to continue to expand the
global distribution of our PIFA Heparin PF/4 Rapid Assay products -
the backbone of the Company - as well as commercialization efforts
associated with other tests including our Tri-Cholesterol assay
being sold under the "First Check" brand. The leadership team
remains focused on building long-term shareholder value from our
products and technologies."
Enquiries:
Akers Biosciences, Inc.
John J. Gormally, Chief Executive Officer
Tel. +1 856 848 8698
finnCap (UK Nominated Adviser and Broker)
Ed Frisby / Scott Mathieson (Corporate Finance)
Steve Norcross (Broking)
Tel. +44 (0)20 7220 0500
Vigo Communications (Global Public Relations)
Ben Simons / Fiona Henson
Tel. +44 (0)20 7390 0234
Email: akers@vigocomms.com
About Akers Biosciences, Inc.
Akers Bio develops, manufactures, and supplies rapid screening
and testing products designed to deliver quicker and more
cost-effective healthcare information to healthcare providers and
consumers. The Company has advanced the science of diagnostics
while responding to major shifts in healthcare through the
development of several proprietary platform technologies. The
Company's state-of-the-art rapid diagnostic assays can be performed
virtually anywhere in minutes when time is of the essence. The
Company has aligned with major healthcare companies and high volume
medical product distributors to maximize product offerings, and to
be a major worldwide competitor in diagnostics.
Additional information on the Company and its products can be
found at www.akersbio.com. Follow us on Twitter @AkersBio.
Cautionary Note Regarding Forward Looking Statements
Statements contained herein that are not based upon current or
historical fact are forward-looking in nature and constitute
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. Such forward-looking
statements reflect the Company's expectations about its future
operating results, performance and opportunities that involve
substantial risks and uncertainties. Such statements may include,
without limitation, statements with respect to the Company's plans,
compliance with the requirements of various regulatory agencies and
certain NASDAQ Stock Market listing rules, objectives, projections,
expectations and intentions and other statements identified by
words such as "projects," "may," "will," "could," "would," "should,
" "believes," "expects," "anticipates," "estimates," "intends,"
"plans," "potential" or similar expressions, as they relate to the
Company, its subsidiaries, or its management. These statements are
based upon the current beliefs and expectations of the Company's
management and are subject to significant risks and uncertainties,
including those detailed in the Company's filings with the
Securities and Exchange Commission. Actual results, performance,
prospects, and opportunities to may differ materially from those
set forth in, or implied by, the forward-looking statements. These
forward-looking statements involve certain risks and uncertainties
that are subject to change based on various factors (many of which
are beyond the Company's control). The Company undertakes no
obligation to publicly update any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2018
OR
[ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
]
For the transition period from __________ to __________
Commission File No. 001-36268
AKERS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
New Jersey 22-2983783
------------------------------ --------------------
(State or other jurisdiction (IRS Employer
of incorporation) Identification No.)
201 Grove Road
Thorofare, NJ 08086
(Address of principal executive offices)
(856) 848-8698
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by section 13 or 15(d) of the
Securities Exchange Act of 1934 during the past 12 months, and (2)
has been subject to such filing requirements for the past 90 days.
Yes [X] No [ ]
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted pursuant
to Rule 405 of Regulation S-T (Sec.232.405 of this chapter) during
the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes [X] No
[ ]
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of "large accelerated filer," "accelerated filer,"
"smaller reporting company" and "emerging growth company" in Rule
12b-2 of the Exchange Act.
Large accelerated filer [ ] Accelerated filer [ ]
Non-accelerated filer [ ] Smaller reporting company [X]
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. [
]
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X]
As of August 13, 2018, there were 94,106,292 shares outstanding
of the registrant's Common Stock.
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
June 30, 2018 and December 31, 2017
As of
-----------------------------------
June 30, 2018 December 31, 2017
(unaudited) (audited)
------------- -------------------
ASSETS
Current Assets
Cash $ 275,963 $ 438,432
Marketable Securities 7,977,575 5,011,607
Trade Receivables, net 412,623 964,671
Deposits and other receivables 30,288 16,590
Deposits and other receivables - Related Party 30,243 -
Inventories, net 1,014,549 947,612
Prepaid expenses 693,632 145,488
Prepaid expenses - Related Party 136,751 251,499
------------ ---------------
Total Current Assets 10,571,624 7,775,899
------------ ---------------
Non-Current Assets
Prepaid expenses - Related Party 208,398 120,118
Property, Plant and Equipment, net 245,462 235,113
Intangible Assets, net 1,045,113 1,130,667
Restricted Cash 500,000 -
Other Assets 76,093 76,093
------------ ---------------
Total Non-Current Assets 2,075,066 1,561,991
------------ ---------------
Total Assets $ 12,646,690 $ 9,337,890
============ ===============
LIABILITIES
Current Liabilities
Trade and Other Payables $ 1,835,180 $ 1,745,216
Trade and Other Payables - Related Party 16,701 39,821
------------ ---------------
Total Current Liabilities 1,851,881 1,785,037
------------ ---------------
Total Liabilities 1,851,881 1,785,037
------------ ---------------
SHAREHOLDERS' EQUITY
Convertible Preferred Stock, No par value, 50,000,000 shares
authorized, 0 and 1,755 shares
issued and outstanding as of June 30, 2018 and December 31, 2017 - 1,755,000
Common Stock, No par value, 500,000,000 shares authorized,
94,106,292 and 44,220,552 issued
and outstanding as of June 30, 2018 and December 31, 2017 119,580,543 110,647,169
Deferred Compensation - (3,469)
Comprehensive Loss (12,443) -
Accumulated Deficit (108,773,291) (104,845,847)
------------ ---------------
Total Shareholders' Equity 10,794,809 7,552,853
------------ ---------------
Total Liabilities and Shareholders' Equity $ 12,646,690 $ 9,337,890
============ ===============
See accompanying notes to these condensed consolidated financial
statements.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and
Comprehensive Loss
For the three and six months ended June 30, 2018 and 2017
(unaudited)
For the Three Months Ended For the Six Months Ended
June 30, June 30,
------------------------------ ----------------------------
2018 2017 2018 2017
---------------- ----------- -------------- -----------
Revenues:
Product Revenue $ 526,601 $ 1,096,925 $ 829,076 $ 1,740,111
Product Revenue - Related party - (24,064) - -
------------ ---------- ---------- ----------
Total Revenues 526,601 1,072,861 829,076 1,740,111
Cost of Sales:
Product Cost of Sales (302,826) (290,591) (600,326) (549,312)
------------ ---------- ---------- ----------
Gross Income 223,775 782,270 228,750 1,190,799
Administrative Expenses 1,565,602 829,929 2,481,134 1,620,457
Sales and Marketing Expenses 442,387 354,889 910,849 911,545
Sales and Marketing Expenses -
Related Party 27,082 61,502 58,771 93,781
Research and Development Expenses 253,371 290,841 644,752 639,283
Research and Development Expenses
- Related Party 5,753 22,994 54,342 22,994
Amortization of Non-Current Assets 42,777 42,777 85,554 85,554
------------ ---------- ---------- ----------
Loss from Operations (2,113,197) (820,662) (4,006,652) (2,182,815)
------------ ---------- ---------- ----------
Other (Income)/Expenses
Foreign Currency Transaction
(Gain)/Loss 3,029 978 5,905 (9,367)
Interest and Dividend Income (48,773) (3,632) (85,113) (6,169)
------------ ---------- ---------- ----------
Total Other Income (45,744) (2,654) (79,208) (15,536)
------------ ---------- ---------- ----------
Loss Before Income Taxes (2,067,453) (818,008) (3,927,444) (2,167,279)
Income Tax Benefit - - - -
------------ ---------- ---------- ----------
Net Loss Attributable to Common
Shareholders (2,067,453) (818,008) (3,927,444) (2,167,279)
------------ ---------- ---------- ----------
Other Comprehensive Income/(Loss)
Net Unrealized Gain/(Loss) on
Marketable Securities 4,401 852 (12,443) 1,009
------------ ---------- ---------- ----------
Total Other Comprehensive
Income/(Loss) 4,401 852 (12,443) 1,009
------------ ---------- ---------- ----------
Comprehensive Loss $ (2,063,052) $ (817,156) $ (3,939,887) $(2,166,270)
============ ========== ========== ==========
Basic and Diluted loss per
common share $ (0.02) $ (0.09) $ (0.05) $ (0.27)
============ ========== ========== ==========
Weighted average basic and
diluted common shares
outstanding 93,254,241 8,882,326 82,348,494 7,943,168
============ ========== ========== ==========
See accompanying notes to these condensed consolidated financial
statements.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statement of Changes in Shareholder's
Equity
For the six months ended June 30, 2018 and 2017
Preferred Common Accumulated
Shares Shares Other
Issued and Preferred Issued and Common Deferred Accumulated Comprehensive Total
Outstanding Stock Outstanding Stock Compensation Deficit Loss Equity
------------ ----------- ----------- ------------ -------------- ------------- --------------- -----------
Balance at December
31, 2017 (audited) 1,755 $ 1,755,000 44,220,552 $110,647,169 $ (3,469) $(104,845,847) $ - $ 7,552,853
Net loss - - - - - (3,927,444) - (3,927,444)
Exercise of
warrants for
common stock - - 38,160,738 7,155,200 - - - 7,155,200
Conversion of
preferred stock
to common stock (1,755) (1,755,000) 11,700,002 1,755,000 - - - -
Amortization of
deferred
compensation - - - - 3,469 - - 3,469
Issuance of
restricted
stock to key
employees - - 25,000 5,175 - - - 5,175
Issuance of
non-qualified
stock options
to key
employees - - - 5,454 - - - 5,454
Issuance of
restricted
stock for
services for
non-employees - - - 12,545 - - - 12,545
Net unrealized
loss on
marketable
securities - - - - - - (12,443) (12,443)
----------- ---------- ----------- ----------- --- --------- ------------ ----------- ----------
Balance at June 30,
2018 (unaudited) - $ - 94,106,292 $119,580,543 $ - $(108,773,291) $ (12,443) $10,794,809
=========== ========== =========== =========== === ========= ============ =========== ==========
See accompanying notes to these condensed consolidated financial
statements.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
For the six months ended June 30, 2018 and 2017
(unaudited)
For the Six Months Ended June 30,
-------------------------------------
2018 2017
------------------- ---------------
Cash flows from operating activities
Net loss $ (3,927,444) $ (2,167,279)
Adjustments to reconcile net loss to net cash used in operating
activities:
Accrued income on marketable securities (16,332) (1,001)
Depreciation and amortization 112,903 121,381
Reserve and write-off for obsolete inventory 32,283 21,542
Reserve for doubtful accounts 97,000 46,239
Amortization of deferred compensation 3,469 15,864
Share based compensation to employees - options 5,454 10,184
Share based compensation to employees - restricted stock 5,175 -
Share based compensation to non-employees - options - 2,183
Share based compensation to non-employees - restricted stock 12,545 -
Changes in assets and liabilities:
(Increase)/decrease in trade receivables 455,048 (372,502)
Decrease in trade receivables - related party - 31,892
(Increase)/decrease in deposits and other receivables (13,698) 10,692
Increase in deposit and other receivables - related party (30,243) -
Increase in inventories (99,220) (213,860)
(Increase)/decrease in prepaid expenses (548,144) 20,752
Decrease in prepaid expenses - related party 26,468 46,890
Increase in other assets - (4,330)
Increase in trade and other payables 89,964 38,278
Decrease in trade and other payables - related party (23,120) (200,156)
--------------- --------------
Net cash used in operating activities (3,817,892) (2,593,231)
--------------- --------------
Cash flows from investing activities
Purchases of property, plant and equipment (37,698) (37,191)
Purchases of marketable securities (5,268,754) (2,705,168)
Proceeds from sale of marketable securities 2,306,675 1,745,554
--------------- --------------
Net cash used in investing activities (2,999,777) (996,805)
--------------- --------------
Cash flows from financing activities
Net proceeds from issuance of common stock - 3,413,311
Net proceeds from exercise of warrants for common stock 7,155,200 301,200
--------------- --------------
Net cash provided by financing activities 7,155,200 3,714,511
--------------- --------------
Net increase in cash and restricted cash 337,531 124,475
Cash and restricted cash at beginning of period 438,432 72,700
--------------- --------------
Cash and restricted cash at end of period $ 775,963 $ 197,175
=============== ==============
Supplemental Schedule of Non-Cash Financing and Investing
Activities
Net unrealized gains/(losses) on marketable securities $ (12,443) $ 1,009
=============== ==============
Issuance of a restricted common stock grant for services $ - $ 5,455
=============== ==============
Conversion of Series B Preferred Stock to common shares $ 1,755,000 $ -
=============== ==============
See accompanying notes to these condensed consolidated financial
statements.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 1 - Organization and Description of Business
Akers Biosciences, Inc. ("Akers"), is a New Jersey corporation.
These condensed consolidated financial statements include two
wholly owned subsidiaries, Akers Acquisition Sub, Inc. and Bout
Time Marketing Corporation, (together, the "Company"). All material
intercompany transactions have been eliminated in
consolidation.
The Company's primary focus is the development and sale of
disposable diagnostic testing devices that can be performed in
minutes, to facilitate time sensitive therapeutic decisions. The
Company's main products are a disposable breathalyzer test that
measures the blood alcohol content of the user, a rapid test
detecting the antibody causing an allergic reaction to Heparin and
a disposable breathalyzer test that measures Free Radical activity
in the human body.
Note 2 - Significant Accounting Policies
(a) Basis of Presentation
The Condensed Consolidated Financial Statements of the Company
are prepared in U.S. Dollars and in accordance with accounting
principles generally accepted in the United States of America (US
GAAP).
Certain information and note disclosures normally included in
the financial statements prepared in accordance with US GAAP have
been condensed. As such, the information included in these
financial statements should be read in conjunction with the audited
financial statements as of and for the years ended December 31,
2017 and 2016 included in the Company's 2017 Form 10-K/
A, Amendment No. 1, as filed on July 13, 2018. In the opinion of
the management, these condensed consolidated financial statements
include all adjustments, consisting of only normal recurring
nature, necessary for a fair statement of the financial position of
the Company as of June 30, 2018 and its results of operations and
cash flows for the three and six months ended June 30, 2018 and
2017. The results of operations for the three and six months ended
June 30, 2018 are not necessarily indicative of the results to be
expected for the full fiscal year ending December 31, 2018.
The Company is an emerging growth company as the term is used in
The Jumpstart Our Business Startups Act enacted on April 5, 2012
and has elected to comply with certain reduced public company
reporting requirements.
(b) Use of Estimates and Judgments
The preparation of financial statements in conformity with US
GAAP requires management to make judgments, estimates and
assumptions that affect the application of accounting policies and
the reported amounts of assets, liabilities, income and expenses.
Actual results may differ from these estimates. Estimates and
underlying assumptions are reviewed on an ongoing basis. Revisions
to accounting estimates are recognized in the period in which the
estimates are revised and in any future periods affected.
Information about significant areas of estimation, uncertainty and
critical judgments in applying accounting policies that have the
most significant effect on the amounts recognized in the financial
statements is included in the following notes for revenue
recognition, allowances for doubtful accounts, inventory
write-downs, impairment of intangible assets and valuation of
share-based payments.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
(c) Functional and Presentation Currency
These condensed consolidated financial statements are presented
in U.S. Dollars, which is the Company's functional currency. All
financial information presented in U.S. Dollars has been rounded to
the nearest dollar. Foreign Currency Transaction Gains or Losses,
resulting from loans and cash balances denominated in Foreign
Currencies, are recorded in the Condensed Consolidated Statement of
Operations and Comprehensive Loss.
(d) Comprehensive Income (Loss)
The Company follows Financial Accounting Standards Board
Accounting Standards Codification (FASB ASC) 220 in reporting
comprehensive income (loss). Comprehensive income is a more
inclusive financial reporting methodology that includes disclosure
of certain financial information that historically has not been
recognized in the calculation of net income.
(e) Cash and Cash Equivalents
Cash and cash equivalents comprise cash balances. The Company
considers all highly liquid investments, which include short-term
bank deposits (up to 3 months from date of deposit) that are not
restricted as to withdrawal date or use, to be cash equivalents.
Bank overdrafts are shown as part of trade and other payables in
the Condensed Consolidated Balance Sheet.
(f) Restricted Cash
At June 30, 2018, restricted cash included in non-current assets
on the Company's condensed consolidated balance sheet was $500,000
representing cash in trust for the purpose of funding legal fees
for certain threatened litigation.
(g) Fair Value of Financial Instruments
The Company's financial instruments consist of cash and cash
equivalents, marketable securities, receivables and trade and other
payables. The carrying value of cash and cash equivalents,
receivables and trade and other payables approximate their fair
value because of their short maturities.
The framework for measuring fair value provides a fair value
hierarchy that prioritizes the inputs to valuation techniques used
to measure fair value. The hierarchy gives the highest priority to
unadjusted quoted prices in active markets for identical assets or
liabilities (level 1) and the lowest priority to unobservable
inputs (level 3). The three levels of the fair value hierarchy
under FASB ASC 820 are described as follows:
Level Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities
1 in active markets that the Company has the ability to access.
Level 2 Inputs to the valuation methodology include:
-- quoted prices for similar assets or liabilities in active markets;
-- quoted prices for identical or similar assets or liabilities in inactive markets;
-- inputs other than quoted prices that are observable for the asset or liability;
-- inputs that are derived principally from or corroborated by observable market data by correlation
or other means
If the asset or liability has a specified (contractual) term, the level 2 input must be observable
for substantially the full term of the asset or liability.
Level Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
3
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
The asset or liability's fair value measurement level within the
fair value hierarchy is based on the lowest level of input that is
significant to the fair value measurement. Valuation techniques
maximize the use of relevant observable inputs and minimize the use
of unobservable inputs.
Following is a description of the valuation methodologies used
for assets measured at fair value as of June 30, 2018 and December
31, 2017.
U.S. Agency Securities and Corporate and Municipal Securities:
Valued using pricing models maximizing the use of observable inputs
for similar securities. This includes basing value on yields
currently available on comparable securities of issuers with
similar credit ratings.
Quoted Prices in Active Quoted Prices for Similar
Markets for Identical Assets or Liabilities
Assets or Liabilities in Active Markets Significant
(Level 1) (Level 2) Unobservable Inputs (Level 3)
------------------------- ------------------------- -------------------------------
Marketable
securities at June
30, 2018 $ - $ 7,977,575 $ -
====== ================= ===== ================== ===========================
Marketable
securities at
December 31, 2017 $ - $ 5,011,607 $ -
------ ----------------- ----- ------------------ ---------------------------
Marketable securities include U.S. agency securities, corporate
securities, and municipal securities, which are classified as
available for sale. The securities are valued at fair market value.
Maturities of the securities are less than one year. Unrealized
gains and losses relating to the available for sale investment
securities were recorded in the Condensed Consolidated Statement of
Changes in Shareholders' Equity as comprehensive income. These
amounts were a decrease of $4,401 and an increase of $12,443 in
unrealized losses for the three and six months ended June 30, 2018.
These amounts were an increase of $852 and $1,009 in unrealized
gains for the three and six months ended June 30, 2017.
Proceeds from the sale of marketable securities in the three and
six months ended June 30, 2018 were $2,004,580 and $2,306,675.
Proceeds from the sale of marketable securities in the three and
six months ended June 30, 2017 were $650,336 and $1,745,554. Gross
gains and losses, resulting from these sales, amounted to a loss of
$4,401 and a gain of $605 for the three months ended June 30, 2018
and 2017 and a loss of $4,401 and $1,656 for the six months ended
June 30, 2018 and 2017.
(h) Trade Receivables, Trade Receivables - Related Party and Allowance for Doubtful Accounts
The carrying amounts of current trade receivables is stated at
cost, net of allowance for doubtful accounts and approximate their
fair value given their short-term nature.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
The normal credit terms extended to customers ranges between 30
and 90 days. Credit terms longer than these may be extended after
considering the credit worthiness of the customers and the business
requirements. The Company reviews all receivables that exceed terms
and establishes an allowance for doubtful accounts based on
management's assessment of the collectability of trade and other
receivables. A considerable amount of judgment is required in
assessing the amount of allowance. The Company considers the
historical level of credit losses, makes judgments about the credit
worthiness of each customer based on ongoing credit evaluations and
monitors current economic trends that might impact the level of
credit losses in the future.
As of June 30, 2018 and December 31, 2017, allowances for
doubtful accounts for trade receivables were $693,196 and $596,196.
Bad debt expenses for trade receivables were $125,500 and $5,380
for the three months ended June 30, 2018 and 2017, respectively,
and $125,500 and $47,741 for the six months ended June 30, 2018 and
2017, respectively.
(i) Concentrations
Financial instruments which potentially subject the Company to
concentrations of credit risk consist principally of cash on
deposit with financial institutions and accounts receivable. At
times, the Company's cash in banks is in excess of the FDIC
insurance limit. The Company has not experienced any loss as a
result of these cash deposits. These cash balances are maintained
with four banks.
Major Customers
For the three months ended June 30, 2018, three customers
generated 33%, 27% and 12%, or 72% in the aggregate, of the
Company's revenue. For the six months ended June 30, 2018, two
customers generated 49% and 17%, or 66% in the aggregate, of the
Company's revenue. As of June 30, 2018, the amount due from these
customers was $291,220. This concentration makes the Company
vulnerable to a near-term severe impact should these relationships
be terminated.
For the three months ended June 30, 2017, two customers
generated 47% and 27%, or 74% in the aggregate, of the Company's
revenue. For the six months ended June 30, 2017, three customers
generated 31%, 29% and 13%, or 73% in the aggregate, of the
Company's revenue.
Three customers accounted for 41%, 13%, and 13% or 67%, in the
aggregate, of gross trade receivables, before accounting for
allowance for doubtful accounts, as of June 30, 2018. To limit such
risks, the Company performs ongoing credit evaluations of its
customers' financial condition. As of June 30, 2018, the Company
had $457,881, $146,195 and $142,293 in trade receivables,
respectively, from these customers.
Major Suppliers
For the three months ended June 30, 2018, two suppliers
accounted for 13% and 11%, or 24% in the aggregate, of the
Company's purchases. For the six months ended June 30, 2018, no
supplier accounted for 10% or more of the Company's purchases.
For the three months ended June 30, 2017, two suppliers
accounted for 15% and 13%, or 28% in the aggregate, of the
Company's purchases. For the six months ended June 30, 2017, one
supplier accounted for 14% of the Company's purchases.
Two vendors accounted for 29% and 12%, or 41%, in the aggregate,
of trade payables as of June 30, 2018. As of June 30, 2018, the
Company had $298,634 and $121,327 in trade payables, respectively,
from these vendors.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
(j) Property, Plant and Equipment
Items of property, plant and equipment are measured at cost less
accumulated depreciation and accumulated impairment losses. Costs
include expenditures that are directly attributable to the
acquisition of the asset.
Gains and losses on disposal of an item of property, plant and
equipment are determined by comparing the proceeds from disposal
with the carrying amount of property, plant and equipment and are
recognized within "other income" in the Condensed Consolidated
Statement of Operations and Comprehensive Loss.
Depreciation is recognized in profit and loss on the accelerated
basis over the estimated useful lives of the property, plant and
equipment. Leased assets are depreciated over the shorter of the
lease term or their useful lives.
Depreciation expense totaled $13,675 and $17,885 for the three
months ended June 30, 2018 and 2017, respectively, and $27,350 and
$35,827 for the six months ended June 30, 2018 and 2017,
respectively.
(k) Intangible Assets
The Company's long-lived intangible assets, other than goodwill,
are assessed for impairment when events or circumstances indicate
there may be an impairment. These assets were initially recorded at
their estimated fair value at the time of acquisition and assets
not acquired in acquisitions were recorded at historical cost.
However, if their estimated fair value is less than the carrying
amount, other intangible assets with indefinite life are reduced to
their estimated fair value through an impairment charge to our
condensed consolidated statements of income.
Intangible assets as of June 30, 2018 and December 31, 2017 were
$1,045,113 and $1,130,667, respectively. Intangible assets at June
30, 2018 consisted of patents, trademarks and customer lists of
$3,897,635 net of accumulated amortization and impairment of
$2,852,522.
Amortization is recognized on a straight-line basis over the
estimated useful lives of intangible assets, other than goodwill,
from the date that they are available for use. Amortization expense
was $42,777 for the three months ended June 30, 2018 and 2017 and
$85,553 for the six months ended June 30, 2018 and 2017.
The following is an annual schedule of approximate future
amortization of the Company's intangible assets:
Period Amount
------------------ --------
2018 (six months) $ 85,554
2019 171,108
2020 149,298
2021 147,315
2022 147,315
2023 147,315
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
(l) Revenue Recognition
In accordance with FASB ASC 605, the Company recognizes revenue
when (i) persuasive evidence of a customer or distributor
arrangement exists, (ii) a retailer, distributor or wholesaler
receives the goods and acceptance occurs, (iii) the price is fixed
or determinable, and (iv) the collectability of the revenue is
reasonably assured. Subject to these criteria, the Company
recognizes revenue from product sales when title passes to the
customer based on shipping terms. The Company typically does not
accept returns nor offer charge backs or rebates except for certain
distributors. Revenue recorded is net of any discount, rebate or
sales return. The accrual for estimated sales returns was $- as of
June 30, 2018 and December 31, 2017. In cases where the right of
return is granted, and the Company does not have historical
experience to reasonably estimate the sales returns, the revenue is
recognized when the return privilege has substantially expired.
The Company may provide for rebates to the distributors under
limited circumstances. The Company established an accrual of
$54,228 and $126,471 as of June 30, 2018 and December 31, 2017.
Accounts receivable will be reduced when the rebates are applied by
the customer. The Company recognized $6,350 and $67,855 during the
three months ended June 30, 2018 and 2017, respectively, for
rebates and $43,894 and $170,678 during the six months ended June
30, 2018 and 2017, respectively, which is included as a reduction
of product revenue in the Condensed Consolidated Statement of
Operations and Comprehensive Loss.
License fee revenue is recognized on a straight-line basis over
the term of the license agreement.
When the Company enters into arrangements that contain more than
one deliverable, the Company allocates revenue to the separate
elements under the arrangement based on their relative selling
prices in accordance with FASB ASC 605-25.
(m) Income Taxes
The Company utilizes an asset and liability approach for
financial accounting and reporting for income taxes. The provision
for income taxes is based upon income or loss after adjustment for
those permanent items that are not considered in the determination
of taxable income. Deferred income taxes represent the tax effects
of differences between the financial reporting and tax basis of the
Company's assets and liabilities at the enacted tax rates in effect
for the years in which the differences are expected to reverse.
The Company evaluates the recoverability of deferred tax assets
and establishes a valuation allowance when it is more likely than
not that some portion or all the deferred tax assets will not be
realized. Management makes judgments as to the interpretation of
the tax laws that might be challenged upon an audit and cause
changes to previous estimates of tax liability. In management's
opinion, adequate provisions for income taxes have been made. If
actual taxable income by tax jurisdiction varies from estimates,
additional allowances or reversals of reserves may be
necessary.
Tax benefits are recognized only for tax positions that are more
likely than not to be sustained upon examination by tax
authorities. The amount recognized is measured as the largest
amount of benefit that is greater than 50 percent likely to be
realized upon settlement. A liability for "unrecognized tax
benefits" is recorded for any tax benefits claimed in the Company's
tax returns that do not meet these recognition and measurement
standards. As of June 30, 2018 and 2017, no liability for
unrecognized tax benefits was required to be reported.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
There was no income tax expense for the three and six months
ended June 30, 2018 and 2017. There is no income tax benefit for
the losses for the three and six months ended June 30, 2018 and
2017 since management has determined that the realization of the
net deferred assets is not assured and has created a valuation
allowance for the entire amount of such tax benefits.
The Company's policy for recording interest and penalties
associated with tax audits is to record such items as a component
of general and administrative expense. There were no amounts
accrued for penalties and interest for the six months ended June
30, 2018 and 2017. The Company does not expect its uncertain tax
position to change during the next twelve months. Management is
currently unaware of any issues under review that could result in
significant payments, accruals or material deviations from its
position.
The Company has identified its federal tax return and its state
tax returns in New Jersey and California as its "major" tax
jurisdictions, and such returns for the years 2014 through 2017
remain subject to examination.
The Tax Cuts and Jobs Act (the "Tax Act") was enacted on
December 22, 2017. The Tax Act reduced the U.S. federal corporate
tax rate from 35% to 21%. As December 31, 2017, the Company had
made a reasonable estimate of the effects of the Tax Act. This
estimate incorporates assumptions made based upon the Company's
current interpretation of the Tax Act and may change as the Company
may receive additional clarification and implementation guidance
and as the interpretation of the Tax Act evolves. In accordance
with Staff Accounting Bulletin No. 118, Income Tax Accounting
Implications of the Tax Cuts and Jobs Act ("SAB 118"), which allows
us to record provisional amounts during a measurement period not to
extend beyond one year form the enactment date. SAB 118 was
codified by the FASB as part of ASU No. 2018-05, Amendments to SEC
Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118. As of
June 30, 2018, we have not made any additional measurement period
adjustments. Such adjustments may be necessary in future periods
due to, among other things, the significant complexity of the Act
and anticipated additional regulatory guidance that may be issued
by the Internal Revenue Service ("IRS"), changes in analysis,
interpretations and assumptions the Company has made and actions
the Company may take as a result of the Act. We are continuing to
gather information to assess the application of the Act and expect
to finalize the accounting for the effects of the Tax Act no later
than the fourth quarter of 2018. Future adjustments made to the
provisional effects will be reported as a component of income tax
expense in the reporting period in which any such adjustments are
determined. Based on the new tax law that lowers corporate tax
rates, on December 31, 2017, the Company revalued its deferred tax
assets.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
(n) Shipping and Handling Fees and Costs
The Company charges actual shipping plus a handling fee to
customers, which amounted to $18,739 and $12,016 for the three
months ended June 30, 2018 and 2017, respectively, and $32,380 and
$30,436 for the six months ended June 30, 2018 and 2017,
respectively. These fees are classified as part of product revenue
in the Condensed Consolidated Statement of Operations and
Comprehensive Loss. Shipping and other related delivery costs,
including those for incoming raw materials consumed are classified
as part of the cost of sales, which amounted to $37,993 and $31,393
for the three months ended June 30, 2018 and 2017, respectively,
and $64,937 and $47,569 for the six months ended June 30, 2018 and
2017, respectively.
(o) Basic and Diluted Earnings per Share of Common Stock
Basic earnings per common share are based on the weighted
average number of shares outstanding during the periods presented.
Diluted earnings per share are computed using the weighted average
number of common shares plus dilutive common share equivalents
outstanding during the period. Potential common shares that would
have the effect of increasing diluted earnings per share are
considered anti-dilutive, i.e. the exercise prices of the
outstanding stock options were greater than the market price of the
common stock.
The calculation of basic and diluted loss per share for the
three months ended June 30, 2018 and 2017 was based on the loss
attributable to common shareholders of $2,067,453 and $818,008,
respectively, and $3,927,444 and $2,167,279 for the six months
ended June 30, 2018 and 2017, respectively. The basic and diluted
weighted average number of common shares outstanding for the three
months ended June 30, 2018 and 2017 was 93,254,241 and 8,882,326,
respectively, and 82,348,494 and 7,943,168 for the six months ended
June 30, 2018 and 2017, respectively.
Diluted net loss per share is computed using the weighted
average number of common and dilutive potential common shares
outstanding during the period.
The following securities are excluded from the calculation of
weighted average dilutive common shares because their inclusion
would have been anti-dilutive:
For the Three and Six Months Ended
June 30,
-------------------------------------
2018 2017
------------------- ----------------
Incentive and Award Stock Options 202,000 259,000
Unvested Restricted Shares of Common Stock - 9,166
Warrants 11,329,833 1,490,570
------------------ ----------------
Total potentially dilutive shares 11,531,833 1,758,736
================== ================
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
(p) Recently Issued Accounting Pronouncements
Recently Issued Accounting Pronouncements Adopted
As the Company is an emerging growth company, it has elected to
adopt recently issued accounting pronouncements based on effective
dates applicable to other than public business entities.
In November 2016, the FASB issued ASU No. 2016-18, Statement of
Cash Flows (Topic 230), Restricted Cash. The amendments in this
Update require that a statement of cash flows explains the change
during the period in the total of cash, cash equivalents, and
amounts generally described as restricted cash or restricted cash
equivalents. Therefore, amounts generally described as restricted
cash and restricted cash equivalents should be included with cash
and cash equivalents when reconciling the beginning-of period and
end-of-period total amounts shown on the statement of cash flows.
The amendments in this Update do not provide a definition of
restricted cash or restricted cash equivalents. The amendments in
this Update are effective for public business entities for fiscal
years beginning after December 15, 2017, and interim periods within
those fiscal years. For all other entities, the amendments are
effective for fiscal years beginning after December 15, 2018, and
interim periods within fiscal years beginning after December 15,
2019. Early adoption is permitted. The Company adopted this as of
January 1, 2018.
Recently Issued Accounting Pronouncements Not Adopted
In May 2014 and April 2016, the FASB issued ASU No. 2014-09 and
ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606).
The core principle of the guidance is that an entity should
recognize revenue to depict 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. In August 2015, FASB issued ASU 2015-14 which
deferred the effective date of Update 2014-09 to annual reporting
periods beginning after December 15, 2018 and for entities other
than public business entities, and to annual reporting periods
beginning after December 15, 2017, including interim reporting
periods within that reporting period for public business entities.
Early application is permitted as of annual reporting periods
beginning after December 15, 2016 including interim reporting
periods within that reporting period. The Company is currently
evaluating the effect of the amendments, but it does not anticipate
a material impact of its financial statements. The Company expects
to use the modified retrospective adoption method and will adopt
this Update as of January 1, 2019.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 2 - Significant Accounting Policies, continued
In June 2018, the FASB issued ASU 2018-07, Compensation-Stock
Compensation (Topic 718): Improvements to Nonemployee Share-Based
Payment Accounting, which expands the scope of Topic 718 to include
share-based payment transactions for acquiring goods and services
from nonemployees. The guidance is effective for public business
entities, certain not-for-profit entities, and certain employee
benefit plans for fiscal years beginning after December 15, 2018,
including interim periods within that fiscal year. For all other
entities, ASU 2018-07 is effective for fiscal years beginning after
December 15, 2019, and interim periods within fiscal years
beginning after December 15, 2020. Early adoption is permitted, but
no earlier than an entity's adoption date of Topic 606. The Company
is evaluating the impact of adopting this pronouncement.
In July 2018, the FASB issued ASU No. 2018-09, Codification
Improvements, to makes changes to a variety of topics to clarify,
correct errors in, or make minor improvements to the Accounting
Standards Codification. Certain items of the amendments in ASU
2018-09 will be effective for the Company in annual periods
beginning after December 15, 2018. The Company is currently
evaluating the effects the adoption of ASU 2018-09 will have on the
consolidated financial statements.
Note 3 - Key Recent Events and Management Plans
On April 25, 2018, the Board of Directors of the Company
terminated Dr. Raymond F. Akers from his position as Executive
Chairman of the Board and from each of his officer positions as
Chief Scientific Director and Secretary of the Company. Dr. Raymond
F. Akers continued as a member of the Board of Directors until his
resignation on May 27, 2018.
On April 25, 2018, the Board appointed Richard Carlyle Tarbox
III, a current director of the Company as the interim Non-Executive
Chairman of the Board, to hold that position until his successor is
appointed, and to the position of Secretary of the Company.
By way of a letter dated May 22, 2018, the Listing
Qualifications Department of the NASDAQ advised the Company that it
did not comply with NASDAQ Listing Rule 5250(c)(1) for continued
listing because NASDAQ has not received the Company's Quarterly
Report. NASDAQ has informed the Company that the Company is
required to submit a plan to regain compliance with NASDAQ's filing
requirements for continued listing within 60 calendar days of the
date of the Notice. NASDAQ has informed the Company that it is in
Compliance with NASDAQ Listing Rule 5250(c)(1) on July 12,
2018.
On June 11, 2018, the Company received a letter from the Listing
Qualifications Department NASDAQ notifying the Company that it has
determined that the Company violated the shareholder approval
requirements of Listing Rule 5635(c). Listing Rule 5635(c) requires
shareholder approval prior to the issuance of securities when a
stock option or purchase plan is to be established or materially
amended or other equity compensation arrangement made or materially
amended, pursuant to which stock may be acquired by officers,
directors, employees or consultants.
Prior to the Company's public offering and listing on NASDAQ,
the Company's 2013 Incentive Stock and Award Plan (the "2013 Plan")
was approved by its Board of Directors. NASDAQ has concluded that
the 2013 Plan was materially amended on two occasions after the
Company's public offering and listing on NASDAQ. The first
amendment, as approved by the Board on January 9, 2015, increased
the number of shares available under the 2013 Plan from 400,000 to
800,000 shares and the second amendment, as approved by the Board
on October 5, 2016, increased the number of shares under the 2013
Plan from 800,000 to 830,000 shares (the "2013 Plan
Amendments").
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 3 - Key Recent Events and Management Plans, continued
During the first quarter of 2018, the Company promptly notified
NASDAQ, as required by Listing Rule 5625, when it became aware of
its potential non-compliance with Listing Rule 5635(c). On May 4,
2018, the Staff requested additional information from the Company
with respect to such non-compliance and on May 31, 2018, the
Company responded. On June 25, 2018, the Company submitted a plan
to NASDAQ to remediate this matter (the "5635 Compliance Plan").
The 5635 Compliance Plan included that a proposal for shareholders
of the Company to ratify the 2013 Plan Amendments be included in
the proxy statement for the Company's 2018 annual meeting of the
shareholders of the Company and that the Company shall suspend the
trading of each share granted, and each share granted upon the
exercise of any option granted, in excess of 400,000 shares under
the 2013 Plan (the number of shares properly approved pursuant to
the 2013 Plan prior to the 2013 Plan Amendments until shareholder
ratification). The 5635 Compliance Plan also proposes to prevent
the exercise of any option granted under the 2013 Plan until
shareholder ratification.
On July 12, 2018, NASDAQ approved of the 5635 Compliance Plan
and granted the Company until December 10, 2018, to regain
compliance with Listing Rule 5635.
On or about June 15, 2018, certain parties brought certain class
action lawsuits against the Company. See Note 10 - Contingencies
for details.
Historically, the Company has relied upon public offerings and
private placements of Common Stock to raise operating capital.
During the year ended December 31, 2017, the Company raised
$9,478,897, net of expenses, in public and private offerings and an
additional $981,948, net of expenses, from the exercise of
warrants. During the six months ended June 30, 2018, the Company
raised an additional $7,155,200 from the exercise of warrants (Note
7). As of August 2, 2018, the Company had cash and marketable
securities of approximately $7.5 million and working capital of
approximately $8.4 million. The Company is not yet able to
determine the impact of the key events during June and July of 2018
may have on the Company's ability to raise capital, nor the impact
that these matters might have on its business operations.
The Company believes that its current working capital position
will be sufficient to meet its obligations as they fall due within
one year after these financial statements are issued.
Note 4 - Inventories
Inventories are measured at the lower of cost or net realizable
value. The cost of inventories is based on the weighted-average
principle, and includes expenditures incurred in acquiring the
inventories, production or conversion costs and other costs
incurred in bringing them to their existing location and condition.
In the case of manufactured inventories and work in progress, costs
include an appropriate share of production overhead based on normal
operating capacity.
Inventories consist of the following:
June 30, 2018 December 31, 2017
--------------- -------------------
Raw Materials $ 544,637 $ 458,441
Sub-Assemblies 937,222 886,274
Finished Goods 745,298 815,505
Reserve for Obsolescence (1,212,608) (1,212,608)
----------- ---------------
$ 1,014,549 $ 947,612
=========== ===============
Obsolete inventory charged to cost of goods during the three
months ended June 30, 2018 and 2017 totaled $7,823 and $21,542,
respectively, and $32,283 and $21,542 during the six months ended
June 30, 2018 and 2017, respectively.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 5 - Trade and Other Payables
Trade and other payables consist of the following:
June 30, 2018 December 31, 2017
--------------- -------------------
Trade Payables $ 1,024,413 $ 948,951
Accrued Expenses 751,017 736,515
Deferred Compensation 59,750 59,750
----------- ---------------
$ 1,835,180 $ 1,745,216
=========== ===============
Trade and other payables - related party are as follows:
June 30, 2018 December 31, 2017
--------------- -------------------
Trade Payables $ 16,701 $ 39,821
----------- --- --------------
$ 16,701 $ 39,821
=========== === ==============
Note 6 - Share-based Payments
On January 23, 2014, upon effectiveness of the registration
statement filed with the SEC, the Company adopted the 2013 Stock
Incentive Plan (the "Plan") which will provide for the issuance of
up to 400,000 shares. The purpose of the Plan is to provide
additional incentive to those officers, employees, consultants and
non-employee directors of the Company and its parents, subsidiaries
and affiliates whose contributions are essential to the growth and
success of the Company's business.
On January 9, 2015, the Board of Directors of the Company
approved, upon recommendation from the Compensation Committee of
the Board, by unanimous written consent the Amended and Restated
2013 Incentive Stock and Award Plan (the "Amended Plan"), which
increases the number of authorized shares of Common Stock subject
to the Plan to 800,000 shares (Note 3)
On September 30, 2016, the Board of Directors increased the
number of authorized shares of Common Stock subject to the Amended
Plan to 830,000 shares. As of June 30, 2018, grants of restricted
stock and options to purchase 202,000 shares of Common Stock have
been issued, pursuant to the Amended Plan, and are unvested or
unexercised and 60,292 shares of Common Stock remain available for
grants under the Amended Plan.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 6 - Share-based Payments, continued
On August 7, 2017, the Shareholders approved and the Company
adopted the 2017 Equity Incentive Plan (the "Plan") which will
provide for the issuance of up to 1,350,000 shares. The purpose of
the Plan is to provide additional incentive to those officers,
employees, consultants and non-employee directors of the Company
and its parents, subsidiaries and affiliates whose contributions
are essential to the growth and success of the Company's business.
As of June 30, 2018, grants totaling 320,107 shares of restricted
Common Stock have been issued pursuant to the Plan and 1,029,893
shares of Common Stock remain available for grants under the
Plan.
The Plan is administered by the Board or a Board-appointed
committee. Eligible recipients of option awards are employees,
officers, consultants or directors (including non-employee
directors) of the Company or of any parent, subsidiary or affiliate
of the Company. The Board has the authority to grant to any
eligible recipient any options, restricted stock or other awards
valued in whole or in part by reference to, or otherwise based on,
the Company's Common Stock.
The Company did not issue any options or warrants under the
above plan during the six months ended June 30, 2018.
Stock Options
The following table summarizes the option activities for the six
months ended June 30, 2018:
Weighted
Weighted Average
Weighted Average Remaining
Number Average Grant Contractual Aggregate
of Exercise Date Term Intrinsic
Shares Price Fair Value (years) Value
-------- ---------- ------------ ----------- -----------
Balance at December 31, 2017 255,000 $ 4.25 $ 2.56 2.02 $ -
Granted - - - - -
Exercised - - - - -
Forfeited (53,000) - 2.69 1.30 -
Canceled/Expired - - - - -
------- ------ -------- ----------- -------
Balance at June 30, 2018 202,000 $ 4.27 $ 2.53 1.59 $ -
======= ====== ======== =========== =======
Exercisable as of June 30, 2018 197,334 $ 4.30 $ 2.53 1.55 $ -
======= ====== ======== =========== =======
The aggregate intrinsic value is calculated as the difference
between the exercise price of the underlying awards and the closing
stock price of $0.387 for the Company's common shares on June 30,
2018.
The numbers of non-vested employee stock options as of June 30,
2018 remained the same as that as of the year ended December 31,
2017 with 4,666 units and a weighted-average grant date fair value
of $2.36.
Unrecognized compensation cost related to non-vested employee
stock options totaled $1,477 as of June 30, 2018. The cost is to be
recognized over a weighted average period of 0.13 years.
During the three months ended June 30, 2018 and 2017, the
Company incurred stock option expenses totaling $2,742 and $7,275,
respectively, and $5,454 and $12,367 during the six months ended
June 30, 2018 and 2017, respectively.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 6 - Share-based Payments, continued
Stock Warrants
The table below summarizes the warrant activity for the six
months ended June 30, 2018:
Weighted Average
Average Remaining Aggregate
Number of Exercise Contractual Intrinsic
Warrants Price Term (years) Value
------------ ---------- ------------ -----------
Balance at December 31, 2017 49,490,571 $ 0.22 4.95 $ -
Granted - - -
Exercised (38,160,738) 0.19 -
Forfeited - - -
Canceled/Expired - - -
----------- ------ ------------ -------
Balance at June 30, 2018 11,329,833 $ 0.35 4.40 $ -
=========== ====== ============ =======
Exercisable as of June 30, 2018 11,329,833 $ 0.35 4.40 $ -
=========== ====== ============ =======
The aggregate intrinsic value is calculated as the difference
between the exercise price of the underlying awards and the closing
stock price of $0.387 for the Company's common shares on June 30,
2018. All warrants were vested on date of grant.
Note 7 - Equity
The holders of common shares are entitled to one vote per share
at meetings of the Company. Holders of Series B convertible
preferred shares have no voting rights at meetings of the
Company.
A restricted stock award is an award of common shares that are
subject to certain restrictions during a specified period.
Restricted stock awards are independent of option grants and are
generally subject to forfeiture if employment terminates prior to
the release of the restrictions. The grantee cannot transfer the
shares before the restricted shares vest. Shares on non-vested
restricted stock have the same voting rights as Common Stock, are
entitled to receive dividends and other distributions thereon and
are considered to be currently issued and outstanding. The Company
expenses the cost of the restricted stock awards, which is
determined to be the fair market value of the shares at the date of
grant, straight-line over the period during which the restrictions
lapse. For these purposes, the fair market value of the restricted
stock is determined based on the closing price of the Company's
Common Stock on the grant date.
On April 11, 2017, the Company issued 10,000 restricted shares
to a consultant for services to be rendered during the year ending
December 31, 2017. These shares vested on the date of the grant.
The fair value of these shares was $18,000 and was based on the
share price on the date of the grant. During the year ended
December 31, 2017, $5,455 was recognized as stock-based
compensation expense. The remaining $12,545 fair value of
restricted shares issued was recognized during the three months
ended March 31, 2018 as sales and marketing expenses on the
Condensed Consolidated Statement of Operations and Comprehensive
Loss.
On January 16, 2018, the Board of Directors issued 25,000
restricted shares of Common Stock to a key employee of the Company
as part of the Plan. The fair value of the shares was $5,175 and
was based on the closing share price of $0.2070 per share. The
share grants vested immediately. The Company recorded the expense
as sales and marketing expenses on the Condensed Consolidated
Statement of Operations and Comprehensive Loss for the six months
ended June 30, 2018.
During the six months ended June 30, 2018, 1,755 shares of the
Company's Series B Preferred Stock, no par value, were converted
into 11,700,002 shares of Common Stock.
During the six months ended June 30, 2018, warrant holders from
the December 21, 2017 public offering exercised 38,160,738 warrants
with an exercise price of $0.1875 per common share, raising net
proceeds of $7,155,200.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 8 - Related Party Transactions
On June 19, 2012, the Company entered into a 3-year exclusive
License & Supply Agreement with ChubeWorkx Guernsey Limited (as
successor to SONO International Limited) ("ChubeWorkx") for the
purchase and distribution of Akers' proprietary breathalyzers
outside North America. ChubeWorkx paid a licensing fee of
$1,000,000 which was recognized over the term of the agreement
through September 30, 2015.
On June 13, 2013, the Company announced an expansion of the
License and Supply Agreement with ChubeWorkx to include worldwide
marketing and distribution of the "Be CHUBE" program using the
Company's breathalyzer.
On August 17, 2016, the Company entered into a Settlement
Agreement (the "Settlement Agreement") with ChubeWorkx Guernsey
Limited ("ChubeWorkx"), a major shareholder, which settled all
pending claims between the Company and ChubeWorkx. Specifically,
the Company and ChubeWorkx agreed to voluntarily dismiss (i) the
action in the United States Federal Court, District of New Jersey
brought by the Company against ChubeWorkx for outstanding amounts
due to the Company under a promissory note and (ii) the action in
The High Court of Justice, Queen's Bench Division Commercial Court,
Royal Courts of Justice, United Kingdom brought by ChubeWorkx
against the Company arising from an exclusive licensing agreement
between ChubeWorkx and the Company ("Licensing Agreement").
Under the terms of the Settlement Agreement, the Company would
receive the full outstanding principal amount in the year ended
December 31, 2016 in the form of $750,000 of BreathScan(R) Alcohol
Detector inventory and the balance of $549,609 as prepaid royalty.
Akers' established an allowance for this doubtful note in the
Company's financial statements for the year ended December 31,
2015. As a result of the Settlement Agreement, the Company reversed
the allowance for doubtful note in the amount of $1,299,609 which
was included in the Consolidated Statement of Operations and
Comprehensive Loss for the year ended December 31, 2016.
In addition to addressing the promissory note described above,
the Settlement Agreement also allows the Company to market and sell
all of the Company's breath technology tests worldwide,
unencumbered by any past/future claims by ChubeWorkx under the
Licensing Agreement (entered into with ChubeWorkx in 2012 and
subsequently amended in 2013). Under the terms of the Settlement
Agreement, ChubeWorkx no longer holds any rights pertaining to
Akers' BreathScan(R) technology, which serves as the basis for
several commercialized products including BreathScan(R) Alcohol
Detector and BreathScan OxiChek(TM); and a number of products in
development.
In return for the Company regaining the full rights to sell
breath technology products, under the terms of the Settlement
Agreement, ChubeWorkx is entitled to receive a royalty of 5% of the
Company's gross revenues (the "ChubeWorkx Royalty") until
ChubeWorkx has earned an aggregate $5,000,000, after which point
ChubeWorkx will no longer be entitled to receive any royalties from
the Company and the Company shall have no further obligation to
ChubeWorkx. The Settlement Agreement further allows the Company to
retain 50% of the ChubeWorkx Royalty until the full $549,609 cash
component of the monies owed by ChubeWorkx to the Company as
described above has been satisfied. The Company recorded royalty
expenses of $27,082 and $61,502 for the three months ended June 30,
2018 and 2017, respectively, and $58,771 and $93,781 for the six
months ended June 30, 2018 and 2017, respectively, which are
included in sales and marketing expenses - related party on the
Condensed Consolidated Statement of Operations and Comprehensive
Loss.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 8 - Related Party Transactions, continued
Other terms of the Settlement include: 1) the pledge as security
of all earned but unpaid royalties by the Company to ChubeWorkx all
Company assets, worthy to satisfy its obligations, including all
inventory and receivables, with the exception of (i) distribution
contracts of the Company or any of its affiliates, (ii) customer
lists, (iii) manufacturing processes (including all intellectual
property required to use those processes and exploit products made
thereby), and (iv) all equipment required to perform said
manufacturing processes and other equipment; 2) the pledge as
security of the settlement sum which remains unpaid by the Company
to ChubeWorkx all Company (i) distribution contracts of the Company
or any of its affiliates, (ii) customer lists, (iii) manufacturing
processes (including all intellectual property required to use
those processes and exploit products made thereby), and (iv) all
equipment required to perform said manufacturing processes and
other equipment; and 3) the grant of voting proxy by ChubeWorkx to
the Company which allows the Company to vote ChubeWorkx's shares
for corporate formalities under certain conditions.
The pledged assets are only at risk in the event that the
Company cannot satisfy any outstanding royalty payment obligations
subject to various cure periods and/or through a restructuring
and/or liquidation under the United States Bankruptcy laws of the
Company in favor of payment of said obligation.
During the three months ended June 30, 2018 and 2017, the
Company recognized sales of $20,265 and $-, respectively, for the
BreathScan Breath Alcohol products acquired from the Settlement and
$20,265 and $- during the six months ended June 30, 2018 and 2017,
respectively.
As of June 30, 2018, the Company owed ChubeWorkx Guernsey
Limited, previously a major shareholder, royalties of $13,541 which
is included in trade and other payables - related party on the
condensed consolidated financial statements.
The Company began purchasing manufacturing molds, plastic
components and the assembled BreathScan Lync(TM) device through
Hainan and its related party during the year ended December 31,
2016. The Company purchased a total of $522 and $- during the three
months ended June 30, 2018 and 2017, respectively, and $4,636 and
$16,774 during the six months ended June 30, 2018 and 2017,
respectively. As of June 30, 2018, the Company owed Hainan and its
related party $3,160 which is included in trade and other payables
- related party on the Condensed Consolidated Balance Sheet.
As of June 30, 2018, the Company owed Hainan $670. Senior
management at Hainan are actively involved in Shenzhen Savy-Akers
Biosciences ("Shenzhen") which is therefore being included as a
related party. The Company owed Shenzhen $2,490 as of June 30,
2018.
On January 31, 2018, the Company engaged Medical Horizons, Inc.
("Medical Horizons"), a company owned and operated by the spouse of
a member of the Company's leadership team, to provide engineering
and design services. The Company recorded $5,753 and $54,342 during
the three and six months ended June 30, 2018, respectively, related
to the engagement of Medical Horizons which is included in research
and development - related party on the Condensed Consolidated
Statement of Operations and Comprehensive Loss.
Product revenue - related party for the three months ended June
30, 2018 and 2017 were $- and credit of $24,064, respectively, and
$- for each of the six months ended June 30, 2018 and 2017,
respectively. The credit of $24,064 was the result of an adjustment
to sales to Hainan and its related party.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 9 - Commitments
The Company leases its facility in West Deptford, New Jersey
under an operating lease ("Thorofare Lease") with annual rentals of
$132,000 plus common area maintenance (CAM) charges. The lease,
which took effect on January 1, 2008, reduced the CAM charges
allowing the Company to reach their own agreements with utilities
and other maintenance providers. On January 7, 2013, the Company
extended its lease agreement for a term of 7 years, expiring
December 31, 2019. Rent expense for the Thorofare Lease, including
related CAM charges for the three months ended June 30, 2018 and
2017 totaled $40,928 and $40,440, respectively, and $83,144 and
$80,927 for the six months ended June 30, 2018 and 2017,
respectively.
The Company entered into a 24-month lease for a satellite office
located in Ramsey, New Jersey ("Ramsey Lease") with annual rents of
$25,980 plus common area maintenance (CAM) charges. The lease took
effect on June 1, 2017 and runs through May 31, 2019. Rent expenses
for the Ramsey Lease, including related CAM charges totaled $6,495
and $2,165 for the three months ended June 30, 2018 and 2017,
respectively, and $12,990 and $2,165 for the six months ended June
30, 2018 and 2017, respectively. The Company posted a security
deposit of $4,330 which is included in other assets on the
Condensed Consolidated Balance Sheet.
The Company entered into a 29-month lease for warehouse space
located in Pitman, New Jersey ("Pitman Lease") with annual rents of
$39,650. The lease took effect on August 1, 2017 and runs through
December 31, 2019. Rent expenses for the Pitman Lease totaled
$9,913 and $- for the three months ended June 30, 2018 and 2017,
respectively, and $19,825 and $- for the six months ended June 30,
2018 and 2017, respectively. A security deposit of $4,950 is
included in other assets on the Condensed Consolidated Balance
Sheet.
The Company entered into a 60-month operating lease for
equipment with annual rentals of $6,156 on September 29, 2014. The
lease commenced on October 21, 2014 upon the delivery of the
equipment.
The Company entered into a 36-month contract with Oracle
Corporation for the NetSuite accounting platform in March 2018 at
an annual cost of $64,938. Implementation of the platform began in
April with a go-live target of January 1, 2019.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 9 - Commitments, continued
The schedule of lease commitments is as follows:
Thorofare Ramsey Pitman Equipment Oracle
Lease Lease Lease Lease NetSuite Total
----------- ------- ------- ----------- ---------- --------
Next 12 Months $ 132,000 $23,815 $39,650 $ 6,156 $ 64,938 $266,559
Next 13-24 Months 66,000 - 19,824 2,052 64,938 152,814
Next 25-36 Months - - - - 43,292 43,292
Note 10 - Contingencies
On October 17, 2016 the Company was served with a notice that
Pulse Health LLC ("Pulse") filed a lawsuit against the Company on
September 30, 2016 in United States Federal District Court,
District of Oregon, alleging a breach of contract under the
settlement agreement entered into by the Company and Pulse on April
8, 2011 which settled all claims and disputes between the Company
and Pulse arising from a previously executed Technology Development
Agreement entered into by the Company and Pulse and damages
resulting from said alleged breach. Additionally, Pulse alleges
false advertising and unlawful trade practices in connection with
the Company's sales activities related to the Company's OxiChek(TM)
products.
The Company filed a series of motions with the Court seeking (1)
to dismiss the Pulse complaint for lack of jurisdiction or, in the
alternative, transfer the matter to the District Court for the
District of New Jersey, Camden Vicinage and (2) to dismiss the
unfair competition claims for failure to state a claim on which
relief could be granted. Oral arguments on these motions were heard
by the Court on March 10, 2017.
The Court decided by order dated April 14, 2017 in favor of the
Company and has dismissed with prejudice the claims brought by
Pulse for unfair competition (both federal and state counts). The
court decided against the Company in its motions for transfer of
venue and for lack of jurisdiction. As such, the case shall proceed
in the District Court of Oregon.
The Company filed a Motion for Summary Judgment on January 24,
2018. On June 21, 2018, the Court ruled in favor of the Company on
some issues and determined that other issues warranted a trial. As
part of its ruling on the Motion for Summary Judgment, the Court
held "While it seems likely that Plaintiff did suffer some amount
of damages, Plaintiff has so far failed to provide a sufficient
evidentiary foundation from which the trier of fact could
reasonably calculate the value of its injury." The Court stated
that it was "reasonably certain that Plaintiff suffered some
damage" and found that Pulse Health "may be entitled to nominal
damages." The Court further determined that equitable relief, such
as an injunction, "may be warranted." Following such rulings, the
Company discovered certain deficiencies in its discovery responses
and is taking the appropriate steps to supplement the record and
correct these deficiencies. In addition, the Court has ordered a
settlement conference in front of a U.S. magistrate to be held on
August 31, 2018. Trial has been set for November 13, 2018 in
Portland, Oregon.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 10 - Contingencies, continued
On or about June 15, 2018, certain parties brought certain class
action lawsuits against the Company.
Faulkner v. Akers Biosciences, Inc., No. 2:18-cv-10521
(D.N.J.)
On June 13, 2018, Plaintiff Tim Faulkner filed a class action
complaint alleging securities violations against Akers Biosciences,
Inc. ("Akers"), John J. Gormally, and Gary M. Rauch ("Individual
Defendants") (together with Akers, "Defendants") on behalf of all
persons and entities who purchased publicly traded Akers securities
from May 15, 2017 through June 5, 2018. The complaint alleges
violations of Section 10(b) of the Exchange Act and Rule 10b-5
against all Defendants, and violations of Section 20(a) of the
Exchange Act against the Individual Defendants. In particular, the
complaint alleges that Defendants made false and/or misleading
statements and/or failed to disclose in its first, second, and
third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was
improperly recognizing revenue for the fiscal year ended December
31, 2017; and, (2) Akers had downplayed weaknesses in its internal
controls over financial reporting and failed to disclose the true
extent of those weaknesses. On July 10, 2018, Plaintiff and
Defendants entered into a stipulation that Defendants are not
required to respond to the complaint until the court appoints a
lead plaintiff and lead counsel for the class, and then after the
lead plaintiff chooses whether to file an amended complaint or
whether to designate the complaint as the operative complaint.
Gleason v. Akers Biosciences, Inc., No. 2:18-cv-10805
(D.N.J.)
On June 20, 2018, Plaintiff David Gleason filed a class action
complaint alleging securities violations against Akers Biosciences,
Inc. ("Akers"), John J. Gormally, and Gary M. Rauch ("Individual
Defendants") (together with Akers, "Defendants") on behalf of all
persons and entities who purchased publicly traded Akers securities
from May 15, 2017 through June 5, 2018. The complaint alleges
violations of Section 10(b) of the Exchange Act and Rule 10b-5
against all Defendants, and violations of Section 20(a) of the
Exchange Act against the Individual Defendants. In particular, the
complaint alleges that Defendants made false and/or misleading
statements and/or failed to disclose in its first, second, and
third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was
improperly recognizing revenue for the fiscal year ended December
31, 2017; and, (2) Akers had downplayed weaknesses in its internal
controls over financial reporting and failed to disclose the true
extent of those weaknesses. No Defendant has been served yet, and
no response is due at this time.
Other class action lawsuits have been threatened against the
Company and may be filed shortly. Although there are currently two
separate actions pending, we anticipate that the two actions will
be consolidated into one action.
The Company maintains D&O liability insurance coverage,
insuring both the Company and the Directors and Officers for
covered defense and indemnification, and has noticed these matters
thereunder.
Additionally, a former executive has threatened to sue the
Company, Board members, and executives under CEPA over the
termination of his employment. That statute prohibits any
retaliatory action against an employee who discloses, or threatens
to disclose to a supervisor or to a public entity any activity,
policy or practice of the employer that is a violation of a law, or
a rule or regulation. Remedies may include a counter claim for back
pay, reinstatement, compensatory and punitive damages and
attorneys' fees if appropriate. The Company will vigorously defend
any litigation brought by this former executive.
The Company intends to establish a rigorous defense of all
claims. The Company is unable to assess the potential outcome, so
no accrual for losses was made as of June 30, 2018. All legal fees
were expensed as and when incurred.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements
Note 11 - Revenue Information
Revenue by product lines was as follows:
Three months ended Six months ended
June 30, June 30,
-------------------- --------------------
Product Line 2018 2017 2018 2017
------------------------------------------ -------- ---------- -------- ----------
MicroParticle Catalyzed Biosensor ("MPC") $106,680 $ 69,848 $125,630 $ 155,507
Particle ImmunoFiltration Assay ("PIFA") 356,082 426,747 616,066 987,668
Rapid Enzymatic Assay ("REA") 45,100 - 55,000 -
Other 18,739 576,266 32,380 596,936
------- --------- ------- ---------
Total Revenue $526,601 $1,072,861 $829,076 $1,740,111
======= ========= ======= =========
The total revenue by geographic area determined based on the
location of the customers was as follows:
Three Months Ended Six Months Ended
June 30, June 30,
-------------------- --------------------
Geographic Region 2018 2017 2018 2017
--------------------------- -------- ---------- -------- ----------
United States $462,383 $ 512,257 $757,116 $1,129,482
People's Republic of China - 478,205 - 502,268
Rest of World 64,218 82,399 71,960 108,361
------- --------- ------- ---------
Total Revenue $526,601 $1,072,861 $829,076 $1,740,111
======= ========= ======= =========
The Company had long-lived assets totaling $66,847 and $59,830
located in the People's Republic of China and $1,223,728 and
$1,305,950 located in the United States as of June 30, 2018 and
December 31, 2017, respectively.
Note 12 - Subsequent Events
On July 26, 2018, the Company implemented a reduction in
workforce plan which resulted in the elimination of six staff
positions in four operating departments.
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations
This quarterly report on Form 10-Q and other reports filed by
Akers Biosciences, Inc. ("Akers", "Akers Bio", "we" or the
"Company") from time to time with the SEC (collectively, the
"Filings") contain or may contain forward-looking statements and
information that are based upon beliefs of, and information
currently available to, the Company's management as well as
estimates and assumptions made by Company's management. Readers are
cautioned not to place undue reliance on these forward-looking
statements, which are only predictions and speak only as of the
date hereof. When used in the Filings, the words "anticipate,"
"believe," "estimate," "expect," "future," "intend," "plan," or the
negative of these terms and similar expressions as they relate to
the Company or the Company's management identify forward-looking
statements. Such statements reflect the current view of the Company
with respect to future events and are subject to risks,
uncertainties, assumptions, and other factors, including the risks
relating to the Company's business, industry, and the Company's
operations and results of operations. Should one or more of these
risks or uncertainties materialize, or should the underlying
assumptions prove incorrect, actual results may differ
significantly from those anticipated, believed, estimated,
expected, intended, or planned.
Although the Company believes that the expectations reflected in
the forward-looking statements are reasonable, the Company cannot
guarantee future results, levels of activity, performance, or
achievements. Except as required by applicable law, including the
securities laws of the United States, the Company does not intend
to update any of the forward-looking statements to conform these
statements to actual results.
Our financial statements are prepared in accordance with
accounting principles generally accepted in the United States
("GAAP"). These accounting principles require us to make certain
estimates, judgments and assumptions. We believe that the
estimates, judgments and assumptions upon which we rely are
reasonable based upon information available to us at the time that
these estimates, judgments and assumptions are made. These
estimates, judgments and assumptions can affect the reported
amounts of assets and liabilities as of the date of the financial
statements as well as the reported amounts of revenues and expenses
during the periods presented. Our financial statements would be
affected to the extent there are material differences between these
estimates and actual results. In many cases, the accounting
treatment of a particular transaction is specifically dictated by
GAAP and does not require management's judgment in its application.
There are also areas in which management's judgment in selecting
any available alternative would not produce a materially different
result. The following discussion should be read in conjunction with
our financial statements and notes thereto appearing elsewhere in
this report.
Overview
Akers Bio develops, manufactures, and supplies rapid,
point-of-care screening and testing products designed to bring
health-related information directly to the patient or clinician in
a timely and cost-efficient manner. Akers believes it has advanced
the science of diagnostics through the development of several
proprietary platform technologies that provide product development
flexibility.
All of Akers' rapid, single-use tests are performed in vitro
(outside the body) and are designed to enhance patient well-being
and reduce the cost of healthcare. The Company's current product
offerings and pipeline products focus on delivering diagnostic
assistance in a wide variety of healthcare fields/specialties,
including diagnostic rapid manual point-of-care tests for the
detection of allergic reactions to Heparin, metabolism/nutrition
and for on- and off-the-job alcohol safety initiatives.
Akers believes that low-cost, single-use testing not only saves
time and money, but allows for more frequent, near-patient testing
which may save lives. We believe that our FDA-cleared rapid
diagnostic tests help facilitate targeted diagnoses and real-time
treatment. We also believe that our rapid diagnostic tests surpass
most other current diagnostic products with their flexibility,
speed, ease-of-use, readability, low cost and accuracy. In minutes,
detection of disease states and medical conditions can be performed
on single-patient specimens without sacrificing accuracy.
We believe the use of rapid tests, which can be performed at the
point-of-care when and where the patient is being consulted, can
result in immediate diagnostic decisions and subsequent treatment
regimens and is an important development in the practice of
medicine. Point-of-care testing addresses today's challenges in the
healthcare industry, such as:
-- cost pressures/efficiency of healthcare delivery;
-- need for affordable mass screening tests for key infectious diseases and metabolic markers;
and
-- need for easy to use, accurate at-home tests for individuals to monitor their personal health
and wellness
The Company has also developed tests for non-medical use within
the health and wellness industry. These tests monitor general
markers of health and wellness as they relate to diet, nutrition
and exercise programs.
Key Events, Management's Plans and Basis of Presentation
On April 25, 2018, the Board of Directors of the Company
terminated Dr. Raymond F. Akers from his position as Executive
Chairman of the Board and from each of his officer positions as
Chief Scientific Director and Secretary of the Company. Dr. Raymond
F. Akers continued as a member of the Board of Directors until his
resignation on May 27, 2018.
On April 25, 2018, the Board appointed Richard Carlyle Tarbox
III, a current director of the Company as the interim Non-Executive
Chairman of the Board, to hold that position until his successor is
appointed, and to the position of Secretary of the Company.
By way of a letter dated May 22, 2018, the Listing
Qualifications Department of the NASDAQ advised the Company that it
did not comply with NASDAQ Listing Rule 5250(c)(1) for continued
listing because NASDAQ has not received the Company's Quarterly
Report. NASDAQ has informed the Company that the Company is
required to submit a plan to regain compliance with NASDAQ's filing
requirements for continued listing within 60 calendar days of the
date of the Notice. NASDAQ has informed the Company that it is in
Compliance with NASDAQ Listing Rule 5250(c)(1) on July 12,
2018.
On June 11, 2018, the Company received a letter from the Listing
Qualifications Department NASDAQ notifying the Company that it has
determined that the Company violated the shareholder approval
requirements of Listing Rule 5635(c). Listing Rule 5635(c) requires
shareholder approval prior to the issuance of securities when a
stock option or purchase plan is to be established or materially
amended or other equity compensation arrangement made or materially
amended, pursuant to which stock may be acquired by officers,
directors, employees or consultants.
Prior to the Company's public offering and listing on NASDAQ,
the Company's 2013 Plan was approved by its Board. NASDAQ has
concluded that the 2013 Plan was materially amended on two
occasions after the Company's public offering and listing on
NASDAQ. The first amendment, as approved by the Board on January 9,
2015, increased the number of shares available under the 2013 Plan
from 400,000 to 800,000 shares and the second amendment, as
approved by the Board on October 5, 2016, increased the number of
shares under the 2013 Plan from 800,000 to 830,000 shares.
During the first quarter of 2018 the Company promptly notified
NASDAQ, as required by Listing Rule 5625, when it became aware of
its potential non-compliance with Listing Rule 5635(c). On May 4,
2018, the Staff requested additional information from the Company
with respect to such non-compliance and on May 31, 2018, the
Company responded. On June 25, 2018, the Company submitted the 5635
Compliance Plan to NASDAQ to remediate this matter. The 5635
Compliance Plan included that a proposal for shareholders of the
Company to ratify the 2013 Plan Amendments be included in the proxy
statement for the Company's 2018 annual meeting of the shareholders
of the Company and that the Company shall suspend the trading of
each share granted, and each share granted upon the exercise of any
option granted, in excess of 400,000 shares under the 2013 Plan
(the number of shares properly approved pursuant to the 2013 Plan
prior to the 2013 Plan Amendments until shareholder ratification).
The 5635 Compliance Plan also proposes to prevent the exercise of
any option granted under the 2013 Plan until shareholder
ratification.
On July 12, 2018, NASDAQ approved of the 5635 Compliance Plan
and granted the Company until December 10, 2018, to regain
compliance with Listing Rule 5635.
On or about June 15, 2018, certain parties brought certain class
action lawsuits against the Company.
Faulkner v. Akers Biosciences, Inc., No. 2:18-cv-10521
(D.N.J.)
On June 13, 2018, Plaintiff Tim Faulkner filed a class action
complaint alleging securities violations against Akers Biosciences,
Inc. ("Akers"), John J. Gormally, and Gary M. Rauch ("Individual
Defendants") (together with Akers, "Defendants") on behalf of all
persons and entities who purchased publicly traded Akers securities
from May 15, 2017 through June 5, 2018. The complaint alleges
violations of Section 10(b) of the Exchange Act and Rule 10b-5
against all Defendants, and violations of Section 20(a) of the
Exchange Act against the Individual Defendants. In particular, the
complaint alleges that Defendants made false and/or misleading
statements and/or failed to disclose in its first, second, and
third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was
improperly recognizing revenue for the fiscal year ended December
31, 2017; and, (2) Akers had downplayed weaknesses in its internal
controls over financial reporting and failed to disclose the true
extent of those weaknesses. On July 10, 2018, Plaintiff and
Defendants entered into a stipulation that Defendants are not
required to respond to the complaint until the court appoints a
lead plaintiff and lead counsel for the class, and then after the
lead plaintiff chooses whether to file an amended complaint or
whether designate the complaint as the operative complaint.
Gleason v. Akers Biosciences, Inc., No. 2:18-cv-10805
(D.N.J.)
On June 20, 2018, Plaintiff David Gleason filed a class action
complaint alleging securities violations against Akers Biosciences,
Inc. ("Akers"), John J. Gormally, and Gary M. Rauch ("Individual
Defendants") (together with Akers, "Defendants") on behalf of all
persons and entities who purchased publicly traded Akers securities
from May 15, 2017 through June 5, 2018. The complaint alleges
violations of Section 10(b) of the Exchange Act and Rule 10b-5
against all Defendants, and violations of Section 20(a) of the
Exchange Act against the Individual Defendants. In particular, the
complaint alleges that Defendants made false and/or misleading
statements and/or failed to disclose in its first, second, and
third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was
improperly recognizing revenue for the fiscal year ended December
31, 2017; and, (2) Akers had downplayed weaknesses in its internal
controls over financial reporting and failed to disclose the true
extent of those weaknesses. No Defendant has been served yet, and
so no response is due at this time.
Other class action lawsuits have been threatened against the
Company and may be filed shortly. Although there are currently two
separate actions pending, we anticipate that the two actions will
be consolidated into one action.
The Company maintains D&O liability insurance coverage,
insuring both the Company and the Directors and Officers for
covered defense and indemnification, and has noticed these matters
thereunder.
As of June 30, 2018, the Company has in large part relied on
equity financing to fund its operations, raising $30,717,381, net
of expenses, in various public and private offering on the NASDAQ
Capital Market and through the exercise of warrants associated with
the offerings. The Company has experienced recurring losses and
negative cash flows from operations. Management's strategic plans
include the following:
-- continuing to advance the development and commercialization of the Company's products, especially
those that utilize MPC Biosensor, PIFA and seraSTAT technologies;
-- continuing to strengthen and forge domestic and international relationships with well-established
sales organizations with strong distribution channels in specific target markets for both
our currently marketed and emerging products;
-- establishing clinical protocols that support regulatory submissions and publication of data
within peer-reviewed journals; and
-- continuing to monitor and implement cost control initiatives to conserve cash.
Despite our plans, the Company expects to continue to incur
losses from operations for the near-term for the following
reasons:
-- some of Akers' distribution partnerships (Diagnostica Stago) have been recently established
or are in the process of being initiated and, therefore, consistent and historical ordering
patterns have not been instituted;
-- the Company continues to incur expenses related to the commercialization and marketing activities
for its existing product platforms and product development (research, clinical trials, regulatory
tasks) costs;
-- and to expand the use of its clinical laboratory products, the Company may need to invest
in additional marketing support programs to increase brand awareness.
At June 30, 2018, Akers had cash (including restricted cash of
$500,000) of $775,963, working capital of $8,719,743, shareholders'
equity of $10,794,809 and an accumulated deficit of $108,773,291.
The Company believes that its current working capital position will
be sufficient to meet its estimated cash needs for at least the
next 12 months. The Company closely monitors its cash balances,
cash needs and expense levels. The Company is not yet able to
determine the impact of the key events during June and July of
2018, as discussed above, on the Company's ability to raise
capital, nor the impact that these matters might have on its
business operations.
Summary of Statements of Operations for the Three Months Ended
June 30, 2018 and 2017
Revenue
Akers' revenue for the three months ended June 30, 2018 totaled
$526,601, a 51% decrease from the same period in 2017. The table
below summarizes our revenue by product line for the three months
ended June 30, 2018 and 2017 as well as the percentage of change
year-over-year:
For the Three Months
Ended June 30, Percent
------------------------
Product Lines 2018 2017 Change
------------------------------------------ ----------- ----------- -------
Particle ImmunoFiltration Assay ("PIFA") $ 356,082 $ 426,747 (17)%
MicroParticle Catalyzed Biosensor ("MPC") 106,680 69,848 53%
Rapid Enzymatic Assay ("REA") 45,100 - 0%
Other 18,739 576,266 (97)%
------- ----------
Total Revenue $ 526,601 $ 1,072,861 (51)%
======= ==========
Revenue from the Company's PIFA Heparin/PF4 Rapid Assay products
decreased 17% to $356,082 (2017: $426,747) during the three months
ended June 30, 2018, over the same period of 2017. The Company is
taking steps to improve its market presence including the use of
specialized Independent Sales Representatives ("ISRs") and through
a program to educate the marketplace through the preparation and
publication of additional clinical studies and physician seminars
on the risks associated with heparin induced thrombocytopenia.
During the three months ended June 30, 2018, we experienced
lower yields in the process of extracting antigen from the
platelets used to produce our PIFA Heparin product. At these yield
levels, our production of this product was under target levels,
resulting in backorders. Our engineers and representatives from our
supplier have been working together to adjust our processes in
order to restore the yield to appropriate levels, the results of
which are not yet determined.
Furthermore, we are evaluating and testing a resolution that may
involve one or more alternative antigen suppliers and processes
that may provide a path to restoring yield levels for this product.
For each of these potential solutions, we will be conducting
production validation and stability testing.
The Company's dedicated technical sales account executives are
supporting over 300 sales representatives of Akers' U.S.
distribution partners, Cardinal Health, Thermo Fisher Scientific
and Diagnostica Stago, and the Company's ISRs. Domestic sales for
the three months ended June 30, 2018, of our distributors, Cardinal
Health, Thermo Fisher Scientific and Diagnostica Stago, accounted
for $327,556 of the total PIFA Heparin/PF4 Rapid Assay sales as
compared to $328,076 for the same period of 2017.
The Company's MPC product sales increased by 53% to $106,680
(2017: $68,848) during the three months ended June 30, 2018. Sales
of the Company's Metron and BreathScan Alcohol products accounted
for the revenue.
The Company's REA products generated $45,100 (2017: $-) during
the three months ended June 30, 2018.
Other revenue decreased to $18,739 (2017: $576,266) during the
three months ended June 30, 2018. The category is made up of the
sales of miscellaneous raw material components, sub-assembled
products and fees billed for shipping and handling charges. During
the three months ended June 30, 2017, the Company received an
initial order for manufacturing components from NovoTek totaling
$500,000. NovoTek plans to utilize these components along with
additional materials to be purchased in a future period to assemble
PIFA Heparin/PF4 products in either the Peoples Republic of China
or Poland.
Gross Margin
The Company's gross margin declined to 42% (2017: 73%) for the
three months ended June 30, 2018, principally on account of the
decline in revenue against a base of certain fixed costs within
product cost of sales. These fixed costs within product cost of
sales consisted principally of direct personnel costs,
manufacturing and warehousing space and depreciation of equipment.
Within these fixed costs, direct personnel costs increased during
the period to $110,629 (2017: $59,612).
Furthermore, during the three months ended June 30, 2018, we
incurred additional product cost of sales of approximately $8,000
in our evaluation, testing and production efforts for the
extraction of antigen from platelets used to produce our PIFA
Heparin product.
As a result, cost of sales for the three months ended June 30,
2018 increased to $302,826 (2017: $290,591). Direct cost of sales
increased to 31% of product revenue while other cost of sales
increased to 26% for the three months ended June 30, 2018 as
compared to 13% and 14% respectively for the same period in 2017 as
described above.
Direct cost of sales for the three-month period ended June 30,
2018 were $164,712 (2017: $143,545). Other cost of sales for the
three months ended June 30, 2018 were $138,114 (2017:
$147,046).
General and Administrative Expenses
General and administrative expenses for the three months ended
June 30, 2018, totaled $1,565,602, which was an 89% increase as
compared to $829,929 for the three months ended June 30, 2017.
The table below summarizes our general and administrative
expenses for the three months ended June 30, 2018 and 2017 as well
as the percentage of change year-over-year:
For the Three Months
Ended June 30, Percent Change
------------------------ --------------
Description 2018 2017
----------------------------------------- -------------- --------
Personnel Costs $ 192,792 $223,944 (14)%
Professional Service Costs 927,812 354,570 162%
Stock Market & Investor Relations Costs 145,771 117,253 24%
Other General and Administrative Costs 299,227 134,162 123%
---------- -------
Total General and Administrative Expense $ 1,565,602 $829,929 89%
---------- -------
Personnel expenses decreased by 14% for the three months ended
June 30, 2018 as compared to the same period of 2017. A reduction
in salaries, wages and bonuses to $162,756 (2017: $177,657) and
employee benefit expenses of $4,994 (2017: $17,326) accounted for
the savings.
Professional service costs increased 162% for the three months
ended June 30, 2018 as compared to the same period of 2017. A
significant increase in legal fees ($605,175 (2017: $171,511)) and
accounting and audit expenses ($236,042 (2017: $104,000)) resulted
in the change. The increase in the legal and accounting fees were
principally in connection with our Board's recent investigation and
the resulting restatement of our previously issued financials, as
well in connection with litigation matters.
Stock exchange fees totaling $45,819 (2017: $12,247) were the
major contributors to the 24% increase in stock market and investor
relations costs for the three months ended June 30, 2018.
Other general and administrative expenses increased by 123%.
This increase is the result of increases in bad debts expense
$125,500 (2017: $5,380) and rent and operating expenses of $79,361
(2017: $42,525) for the rental of the Ramsey, New Jersey satellite
office.
Sales and Marketing Expenses
Sales and marketing expenses for the three months ended June 30,
2018 totaled $469,469 which was a 13% increase compared to $416,391
for the three months ended June 30, 2017.
The table below summarizes our sales and marketing expenses for
the three months ended June 30, 2018 and 2017 as well as the
percentage of change year-over-year:
For the Three Months
Ended June 30,
------------------------
Description 2018 2017 Percent Change
--------------------------------------- ------------- --------- --------------
Personnel Costs $ 266,889 $ 181,653 47%
Professional Service Costs 69,065 72,079 (4)%
Royalties and Outside Commission Costs 69,983 103,702 (33)%
Other Sales and Marketing Costs 63,532 58,957 8%
--------- --------
Total Sales and Marketing Expenses $ 469,469 $ 416,391 13%
--------- --------
The US market has been divided into two regional zones, each
with a business director that is responsible for recruiting and
supporting ISRs and independent manufacturing representatives
("IMRs") to target large integrated delivery networks and
individual facilities. This strategy requires more experienced and
technically knowledgeable sales personnel to interact with
surgeons, executive management, laboratory and medical directors.
The Company has increased its sales and marketing staff from 4
members on June 30, 2017 to 5 as of June 30, 2018.
Personnel costs increased in the three months ended June 30,
2018 as compared to the same period of 2017. A increase in
compensation, bonuses, commissions and severance payments to
$219,754 (2017: $153,273) primarily due to changes in the bonus and
compensation plan and adjustments to staffing.
The legal settlement with ChubeWorkx Guernsey, Ltd
("ChubeWorkx"), signed on August 11, 2016, requires the Company to
pay a 5% royalty on adjusted gross sales to ChubeWorkx on a
quarterly basis. During the three months ended June 30, 2018, this
royalty totaled $27,082 (2017: $61,502).
The Company recognized reductions in computer expenses ($11,709
(2017: $21,099)) plus smaller reductions in several other operating
categories which were offset by an increase in travel expenses
($33,210 (2017: $21,065)) that resulted in an 8% increase in other
sales and marketing costs.
Research and Development
Research and development expenses for the three months ended
June 30, 2018 totaled $259,123, which was a 17% decrease as
compared to $313,835 for the three months ended June 30, 2017.
The table below summarizes our research and development expenses
for the three months ended June 30, 2018 and 2017 as well as the
percentage of change year-over-year:
For the Three Months
Ended June 30,
------------------------
Description 2018 2017 Percent Change
---------------------------------------- ------------- --------- --------------
Personnel Costs $ 176,202 $ 227,887 (23)%
Clinical Trial Costs 575 150 283%
Professional Service Costs 48,620 18,588 162%
Other Research and Development Costs 33,727 67,210 (50)%
--------- --------
Total Research and Development Expenses $ 259,124 $ 313,835 (17)%
--------- --------
Personnel costs decreased 23% during the three months ended June
30, 2018 as compared to the same period of 2017. On April 25, 2018,
the Board of Directors of the Company terminated Dr. Raymond F.
Akers from his position as Executive Chairman of the Board and from
each of his officer positions as Chief Scientific Director and
Secretary of the Company resulting in the decline in personnel
costs.
Professional services consisted of fees paid to engineering
consultants to address production mold designs, specialized tooling
and manufacturing process development, regulatory consultants to
assist with governmental filings and facility certifications and
the medical director. Engineering service costs increased to
$25,304 (2017: $5,630) and other general and regulatory consulting
fees totaled $23,316 (2017: $12,848) in the three months ended June
30, 2018.
Decreases in laboratory supplies ($10,665 (2017: $34,124)) and
the consumption of raw materials ($1,888 (2017: $11,851)) resulted
in a decrease of 50% for other research and development costs
during the three months ended June 30, 2018.
Other Income and Expense
Other income, net of expense for the three months ended June 30,
2018 totaled $45,744, which was a 1,624% increase as compared to
$2,654 for the three months ended June 30, 2017.
The table below summarizes our other income and expenses for the
three months ended June 30, 2018 and 2017 as well as the percentage
of change year-over-year:
For the Three Months
Ended June 30,
------------------------
Description 2018 2017 Percent Change
------------------------------------ ------------- -------- --------------
Currency Translation Loss $ (3,029) $ (978) 210%
Realized Gains on Investments (4,400) 605 (827)%
Interest and Dividends 53,173 3,027 1,657%
--------- -------
Total Other Income, Net of Expenses $ 45,744 $ 2,654 1,624%
--------- -------
Losses associated with foreign currency transactions totaled
$3,029 during the three months ended June 30, 2018 as compared to a
loss of $978 the same period of 2017, primarily a result of the
increased strength of the British Pound as compared to the US
Dollar.
Realized gains, interest and dividend income increased to
$48,773 (2017: $3,632). The Company's available capital for
investment activities increased significantly due to the capital
raise in December 2017 and the subsequent exercises of warrants
during the three months ended June 30, 2018 resulting in the
increase in investment income.
Summary of Statements of Operations for the Six Months Ended
June 30, 2018 and 2017
Revenue
Akers' revenue for the six months ended June 30, 2018 totaled
$829,076, a 52% decrease from the same period in 2017. The table
below summarizes our revenue by product line for the six months
ended June 30, 2018 and 2017 as well as the percentage of change
year-over-year:
For the Six Months
Ended June 30,
--------------------
Product Lines 2018 2017 Percent Change
------------------------------------------ -------- ---------- --------------
Particle ImmunoFiltration Assay ("PIFA") $616,066 $ 987,668 (38)%
MicroParticle Catalyzed Biosensor ("MPC") 125,630 155,507 (19)%
Rapid Enzymatic Assay ("REA") 55,000 - -
Other 32,380 596,936 (95)%
------- ---------
Total Revenue $829,076 $1,740,111 (52)%
======= =========
Revenue from the Company's PIFA Heparin/PF4 Rapid Assay products
decreased 38% to $616,066 (2017: $987,668) during the six months
ended June 30, 2018, over the same period of 2017. The Company is
taking steps to improve its market presence including the use of
specialized Independent Sales Representatives ("ISRs") and through
a program to educate the marketplace through the preparation and
publication of additional clinical studies and physician seminars
on the risks associated with heparin induced thrombocytopenia.
During the six months ended June 30, 2018, we experienced lower
yields in the process of extracting antigen from the supplier
provided platelets used to produce our PIFA Heparin product. At
these yield levels, our production of this product was under target
levels, resulting in backorders. Our engineers and representatives
from our supplier have been working together to adjust our
processes in order to restore the yield to appropriate levels, the
results of which are not yet determined.
Furthermore, we are evaluating and testing a resolution that may
involve one or more alternative antigen suppliers and processes
that may provide a path to restoring yield levels for this product.
For each of these potential solutions, we will be conducting
production validation and stability testing.
The Company's dedicated technical sales account executives are
supporting over 300 sales representatives of Akers' U.S.
distribution partners, Cardinal Health, Thermo Fisher Scientific,
Diagnostica Stago and the Company's ISRs. Domestic sales for the
six months ended June 30, 2018, of our distributors, Cardinal
Health, Thermo Fisher Scientific and Diagnostica Stago accounted
for $537,027 of the total PIFA Heparin/PF4 Rapid Assay sales as
compared to $765,653 for the same period of 2017.
The Company's MPC product sales decreased by 19% to $125,630
(2017: $155,508) during the six months ended June 30, 2018. Sales
of the Company's Metron and BreathScan Alcohol products accounted
for the revenue.
The Company's REA products generated $55,000 (2017: $-) during
the six months ended June 30, 2018. The Company's re-introduced
Tri-Cholesterol product is produced with this technology.
Other revenue decreased to $32,380 (2017: $596,935) during the
six months ended June 30, 2018. The category is made up of the
sales of miscellaneous raw material components, sub-assembled
products and fees billed for shipping and handling charges. During
the six months ended June 30, 2017, the Company received an initial
order for manufacturing components from NovoTek totaling $500,000.
NovoTek plans to utilize these components along with additional
materials to be purchased in a future period to assemble PIFA
Heparin/PF4 products in either the Peoples Republic of China or
Poland.
Gross Margin
The Company's gross margin declined to 28% (2017: 68%) for the
six months ended June 30, 2018 principally on account of the
decline in revenue against a base of certain fixed costs within
product cost of sales. These fixed costs within product cost of
sales consisted principally of direct personnel costs,
manufacturing and warehousing space, depreciation of equipment.
Within these fixed costs, direct personnel costs increased during
the period to $207,453 (2017: $124,965).
Furthermore, during the six months ended June 30, 2018, we
incurred additional product cost of sales of approximately $19,200
in our evaluation, testing and production efforts for the
extraction of antigen from platelets used to produce our PIFA
Heparin product.
As a result, cost of sales for the six months ended June 30,
2018 increased to $600,326 (2017: $549,312). Direct cost of sales
increased to 36% of product revenue while other cost of sales
increased to 36% for the six months ended June 30, 2018 as compared
to 15% and 17% respectively for the same period in 2017 as
described above.
Direct cost of sales for the six -month period ended June 30,
2018 were $297,365 (2017: $249,673). Other cost of sales for the
six months ended June 30, 2018 were $302,961 (2017: $299,639).
General and Administrative Expenses
General and administrative expenses for the six months ended
June 30, 2018, totaled $2,481,135, which was a 53% increase as
compared to $1,620,457 for the six months ended June 30, 2017.
The table below summarizes our general and administrative
expenses for the six months ended June 30, 2018 and 2017 as well as
the percentage of change year-over-year:
For the Six Months
Ended June 30,
----------------------
Description 2018 2017 Percent Change
----------------------------------------- ---------- ---------- --------------
Personnel Costs $ 499,727 $ 558,471 (11)%
Professional Service Costs 1,231,750 546,322 125%
Stock Market & Investor Relations Costs 259,937 199,639 30%
Other General and Administrative Costs 489,721 316,025 55%
--------- ---------
Total General and Administrative Expense $2,481,135 $1,620,457 53%
--------- ---------
Personnel expenses decreased by 11% for the six months ended
June 30, 2018 as compared to the same period of 2017. A reduction
in salaries, wages and bonuses to $406,697 (2017: $455,113) and
employee benefit expenses of $20,739 (2017: $31,612) accounted for
the savings.
Professional service costs increased by 125% for the six months
ended June 30, 2018 as compared to the same period of 2017. A
significant increase in legal fees ($883,451 (2017: $310,198)) and
accounting and audit services ($236,042 (2017: $104,000)) were
offset partially by a decrease in engineering fees $14,658 (2017:
$56,794). The increase in the legal and accounting fees were
principally in connection with our Board's recent investigation and
the resulting restatement of our previously issued financials, as
well in connection with litigation matters.
Stock exchange fees totaled $116,001 (2017: $106,687) and
transfer agent fees of $34,308 (2017: $21,124) were the major
contributors to the 30% increase in stock market and investor
relations costs for the six months ended June 30, 2018.
Other general and administrative expenses increased by 55%. This
increase is the result of increases in bad debts expenses of
$125,500 (2017: $47,741), rent and operating expenses of $154,270
(2017: $87,778) for the addition of the Ramsey, New Jersey
satellite office and insurance expenses of $95,752 (2017:
$76,580).
Sales and Marketing Expenses
Sales and marketing expenses for the six months ended June 30,
2018 totaled $969,620 which was a 4% decrease compared to
$1,005,326 for the six months ended June 30, 2017.
The table below summarizes our sales and marketing expenses for
the six months ended June 30, 2018 and 2017 as well as the
percentage of change year-over-year:
For the Six Months
Ended June 30,
--------------------
Description 2018 2017 Percent Change
--------------------------------------- -------- ---------- --------------
Personnel Costs $588,598 $ 517,485 14%
Professional Service Costs 140,623 137,126 3%
Royalties and Outside Commission Costs 97,838 148,836 (34)%
Other Sales and Marketing Costs 142,561 201,879 (29)%
------- ---------
Total Sales and Marketing Expenses $969,620 $1,005,326 (4)%
------- ---------
Personnel costs increased in the six months ended June 30, 2018
as compared to the same period of 2017. This was due to an increase
in compensation, bonuses and commissions and severance payments to
$476,106 (2017: $446,542) and employee benefit expenses of $27,327
(2017: $13,075) primarily due to changes in the bonus and
compensation plan and adjustments to staffing.
During the six months ended June 30, 2018, the ChubeWorkx
royalty totaled $58,771 (2017: $93,781) and commissions to IMRs
were $39,067 (2017: $55,055) which contributed to the decline in
royalty and outside commission costs during the six months ended
June 30, 2018.
The Company recognized significant reductions in advertising
expenses ($12,167 (2017: $54,700)) and trade show expenses ($885
(2017: $30,742)) plus smaller reductions in several other operating
categories was offset by an increase in travel expenses ($60,921
(2017: $50,923)) that resulted in a 29% reduction in other sales
and marketing costs.
Research and Development
Research and development expenses for the six months ended June
30, 2018 totaled $699,094, which was a 6% increase as compared to
$662,277 for the six months ended June 30, 2017.
The table below summarizes our research and development expenses
for the six months ended June 30, 2018 and 2017 as well as the
percentage of change year-over-year:
For the Six Months
Ended June 30,
----------------------
Description 2018 2017 Percent Change
---------------------------------------- ------------ -------- --------------
Personnel Costs $ 475,415 $512,837 (7)%
Clinical Trial Costs 1,480 300 393%
Professional Service Costs 137,896 47,711 189%
Other Research and Development Costs 84,303 101,429 (17)%
-------- -------
Total Research and Development Expenses $ 699,094 $662,277 6%
-------- -------
Personnel costs decreased 7% during the six months ended June
30, 2018 as compared to the same period of 2017. On April 25, 2018,
the Board of Directors of the Company terminated Dr. Raymond F.
Akers from his position as Executive Chairman of the Board and from
each of his officer positions as Chief Scientific Director and
Secretary of the Company resulting in the decline in personnel
costs.
Professional services consisted of fees paid to engineering
consultants to address production mold designs, specialized tooling
and manufacturing process development, regulatory consultants to
assist with governmental filings and facility certifications and
the medical director. Engineering service costs increased to
$97,800 (2017: $23,335), fees for the other general and regulatory
consulting fees totaled $40,096 (2017: $21,503) in the six months
ended June 30, 2018.
Decreases in laboratory supplies ($26,306 (2017: $42,183)) and
travel expenses ($5,067 (2017: $19,593)) resulted in a decrease of
17% for other research and development costs during the six months
ended June 30, 2018.
Other Income and Expense
Other income, net of expense for the six months ended June 30,
2018 totaled $79,209, which was a 410% increase as compared to
$15,536 for the six months ended June 30, 2017.
The table below summarizes our other income and expenses for the
six months ended June 30, 2018 and 2017 as well as the percentage
of change year-over-year:
For the Six Months
Ended June 30,
----------------------
Description 2018 2017 Percent Change
------------------------------------ ----------- -------- --------------
Currency Translation Gain/(Loss) $ (5,904) $ 9,367 (163)%
Realized Gains on Investments (4,401) 1,656 (366)%
Interest and Dividends 89,514 4,513 1,883%
------- -------
Total Other Income, Net of Expenses $ 79,209 $ 15,536 410%
------- -------
Losses associated with foreign currency transactions totaled
$5,904 during the six months ended June 30, 2018 as compared to a
gain of $9,367 the same period of 2017, primarily a result of the
increased strength of the British Pound as compared to the US
Dollar.
Realized gains, interest and dividend income increased to
$85,113 (2017: $6,169). The Company's available capital for
investment activities increased significantly due to the capital
raise in December 2017 and the subsequent exercises of warrants
during the three months ended June 30, 2018 resulting in the
increase in investment income.
Income Taxes
As of June 30, 2018, the Company does not believe any uncertain
tax positions exist that would result in the Company having a
liability to the taxing authorities. The Company's policy is to
classify interest and penalties related to unrecognized tax
benefits, if and when required, as part of interest expense and
general and administrative expense, respectively in the
consolidated statement of operations.
Liquidity and Capital Resources
For the six months ended June 30, 2018 and 2017, the Company
generated a net loss attributable to shareholders of $3,927,444 and
$2,167,279, respectively. As of June 30, 2018 and December 31,
2017, the Company has an accumulated deficit of $108,773,291 and
$104,845,847 and had cash (excluding restricted cash) and
marketable securities totaling $8,253,538 and $5,450,039,
respectively.
Our primary focus is to expand the global distribution of our
PIFA Heparin PF/4 rapid assays. The Company continues
commercialization of its BreathScan OxiChek, BreathScan Lync
Readers, METRON, BreathScan Alcohol detection devices and the
Tri-Cholesterol assay and development activities for PIFA PLUSS
Chlamydia rapid assay and BreathScan KetoChek products.
We expect to continue to incur losses from operations for the
near-term and these losses could be significant as we incur product
development, clinical and regulatory activities, contract
consulting and other product development and commercialization
related expenses. We expect that our current working capital
position will be sufficient to meet our estimated cash needs for at
least the next twelve months. We are closely monitoring our cash
balances, cash needs and expense levels. The accompanying financial
statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets
or the amounts and classification of liabilities that might result
in the possible inability of the Company to continue as a going
concern.
We expect that our primary expenditures will be to continue
development of BreathScan KetoChek via the enrollment of patients
in clinical trials.to support performance claims and generate
studies in peer-reviewed journals to support product marketing. We
will also continue to support commercialization and marketing
activities of in-line products PIFA Heparin/PF4 rapid assays, PIFA
PLUSS(R) PF4, breath alcohol detectors, METRON BreathScan OxiChek
and BreathScan Lync Readers globally. Based upon our experience,
clinical trial and related regulatory expenses can be significant
costs. Steps to achieve commercialization of emerging products will
be an ongoing and evolving process with expected improvements and
possible subsequent generations being evaluated for commercialized
and emerging tests. Should we be unable to achieve FDA clearance
for products that require such regulatory "approval", develop
performance characteristics for rapid tests that satisfy market
needs, or generate sufficient revenue from commercialized products,
we would need to rely on other business or product opportunities to
generate revenue and costs that we have incurred for the patents
may be deemed impaired.
Capital expenditures for the six months ended June 30, 2018 were
$37,698 (2017: $37,191). Capital expenditures, primarily for
production, laboratory and facility improvement costs for the year
ending December 31, 2018 are expected to be approximately $60,000.
As per the Company's lease agreement, the owner of the facility
will be handling most of the facility upgrades, and we anticipate
financing any production and laboratory capital expenditures
through working capital.
The Company may enter into generally short-term consulting and
development agreements primarily for testing services and in
connection with clinical trials conducted as part of the Company's
development process which may include activities related to the
development of technical files for FDA 510(k) clearance
submissions. Such commitments at any point in time may be
significant but the agreements typically contain cancellation
provisions.
We lease our manufacturing facility which also contains our
administrative offices. Our current lease was executed January 1,
2013 and is effective through December 31, 2019. The Company has
leased this property from the current owner since 1997. The Company
executed a lease for a satellite office in Ramsey, New Jersey on
June 23, 2017 which expires May 31, 2019. The satellite office
supports members of executive management and the sales and
marketing team with convenient access to resources in the greater
New York City area.
Due to recent market events that have adversely affected all
industries and the economy as a whole, management has placed
increased emphasis on monitoring the risks associated with the
environment, particularly the recoverability of current assets, the
fair value of assets, and the Company's liquidity. At this point in
time, there has not been a material impact on the Company's assets
and liquidity. Management will continue to monitor the risks
associated with the environment and their impact on the Company's
results.
Our net cash consumed by operating activities totaled $3,817,892
during the six months ended June 30, 2018. Cash was consumed by the
loss of $3,927,444 plus non-cash adjustments of $112,903 for
depreciation and amortization of non-current assets, $3,469 for the
amortization of deferred compensation, $32,283 for the reserve and
write-off for obsolete inventory, $97,000 for the reserve and
write-off of doubtful accounts, $10,629 for share based
compensation to employees and $12,545 for share based compensation
to non-employees less $16,332 for accrued interest and dividends on
marketable securities. For the six months ended June 30, 2018,
decreases in trade receivables of $455,048, prepaid expenses -
related party of $26,468 and an increase in trade and other
payables of $89,964 provided cash, primarily related to routine
changes in operating activities. A net increase in deposits and
other receivables of $13,698, deposits and other receivables -
related party of $30,243, inventory of $99,220, prepaid expenses of
$548,144, and a decrease in trade and other payables - related
party of $23,120 consumed cash from operating activities.
Our net cash consumed by operating activities totaled $2,593,231
during the six months ended June 30, 2017. Cash was consumed by the
loss of $2,167,279 plus non-cash adjustments of $121,381 for
depreciation and amortization of non-current assets, $21,542 for
the write-off and reserve for obsolete inventory, $46,239 for the
reserve and write-off of doubtful accounts, $15,864 for the fair
value of restricted common stock issued for services and $12,367
for share-based compensation less $1,001 for accrued interest and
dividends on marketable securities. For the six months ended June
30, 2017, decreases in deposits and other receivables of $10,692,
trade receivables - related parties of $31,892, prepaid expenses of
$20,752, prepaid expenses - related party of $46,890, and an
increase in trade and other payables of $38,278 provided cash,
primarily related to routine changes in operating activities. A net
increase in trade receivables of $372,502, inventories of $213,860
and other assets of $4,330 and decreases trade and other payables -
related party of $200,156 consumed cash from operating
activities.
Investing and Financing Activities
The Company's net cash provided by investing and financing
activities totaled $4,155,423 (2017: $2,717,706) during the six
months ended June 30, 2018. Cash of $5,306,452 (2017: $2,742,359)
was consumed by capital expenditures and the purchase of marketable
securities. Proceeds from the sale of marketable securities
contributed cash of $2,306,675 (2017: $1,745,554) and net proceeds
from the public and private placements of common and Series B
preferred stock and the exercise of warrants for Common Stock
contributed $7,155,200 (2017: $3,714,511) for the six months ended
June 30, 2018.
Critical Accounting Policies
See accounting policies in Note 2 of the condensed consolidated
financial statements included in Part I, Item 1 of this report.
Off-Balance Sheet Arrangements
We have no significant known off balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosures About Market
Risk
We do not hold any derivative instruments and do not engage in
any hedging activities.
Item 4. Controls and Procedures.
(a) Evaluation of Disclosure Controls and Procedures
Pursuant to Rule 13a- 15(b) under the Exchange Act, the Company
carried out an evaluation, with the participation of the Company's
management, including the Company's Principal Executive Officer
("PEO") and Principal Financial Officer ("PFO"), of the
effectiveness of the Company's disclosure controls and procedures
(as defined under Rule 13a-15(e) under the Exchange Act) as of the
end of the period covered by this report.
Subsequent to the filing of the Company's Form 10-K for the year
ended December 31, 2017, the Company determined that there were
material errors within its Quarterly Reports on Form 10-Q for the
periods ended June 30, 2017 and September 30, 2017 and in its
Annual Report on Form 10-K for the year ended December 31, 2017.
Specifically, the Company determined that certain revenue
transactions did not qualify for revenue recognition under
generally accepted accounting principles, that certain obligations
were not recorded as expenses on a timely basis and that the
Company did not properly value its inventory. The Company concluded
that the impact of applying corrections for these errors was
materially different from its previously reported results under its
historical practice.
As of June 30, 2018 and based upon that evaluation, and in light
of the restatement discussion above, the Company's PEO and PFO
concluded that the Company's disclosure controls and procedures
were not effective to ensure that information required to be
disclosed by the Company in the reports that the Company files or
submits under the Exchange Act, are recorded, processed, summarized
and reported, within the time periods specified in the SEC's rules
and forms, and that such information is accumulated and
communicated to the Company's management, including the Company's
PEO and PFO, as appropriate, to allow timely decisions regarding
required disclosure.
Management is actively engaged in the planning for and
implementation of remediation efforts to address the material
weakness identified above. The remediation plan includes (i) the
hiring of an additional experienced financial executive which was
consummated on July 9, 2018, (ii) the development and
implementation of enhanced controls designed to evaluate the
appropriateness of revenue recognition policies and procedures,
(iii) the implementation of review and monitoring of transactions
to ensure compliance with the new policies and procedures, and (iv)
the training of personnel responsible for revenue and
inventory.
(b) Changes in Internal Control over Financial Reporting
The company has implemented additional controls around sales
transactions to (i) further validate shipping terms including, the
date for which risk of ownership transfers to the purchaser and
(ii) that shipped product met purchasers' specifications. In
connection with the preparation of the condensed consolidated
financial statements for the quarter ended June 30, 2018, the
Company engaged a third party consultant to assist in the review of
financial statements and to address complex accounting matters.
There have been no other changes in our internal control over
financial reporting identified in connection with the evaluation
required by paragraph (d) of Rules 13a-15 or 15d-15 under the
Exchange Act that occurred during the fiscal quarter ended June 30,
2018 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial
reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we are a party to litigation and subject to
claims incident to the ordinary course of business. Future
litigation may be necessary to defend ourselves and our customers
by determining the scope, enforceability and validity of third
party proprietary rights or to establish our proprietary
rights.
On October 17, 2016 the Company was served with a notice that
Pulse Health LLC ("Pulse") filed a lawsuit against the Company on
September 30, 2016 in United States Federal District Court,
District of Oregon, alleging a breach of contract under the
settlement agreement entered into by the Company and Pulse on April
8, 2011 which settled all claims and disputes between the Company
and Pulse arising from a previously executed Technology Development
Agreement entered into by the Company and Pulse and damages
resulting from said alleged breach. Additionally, Pulse alleges
false advertising and unlawful trade practices in connection with
the Company's sales activities related to the Company's OxiChek(TM)
products.
The Company filed a series of motions with the Court seeking (1)
to dismiss the Pulse complaint for lack of jurisdiction or, in the
alternative, transfer the matter to the District Court for the
District of New Jersey, Camden Vicinage and (2) to dismiss the
unfair competition claims for failure to state a claim on which
relief could be granted. Oral arguments on these motions were heard
by the Court on March 10, 2017.
The Court decided by order dated April 14, 2017 in favor of the
Company and has dismissed with prejudice the claims brought by
Pulse for unfair competition (both federal and state counts). The
court decided against the Company in its motions for transfer of
venue and for lack of jurisdiction. As such, the case shall proceed
in the District Court of Oregon.
The Company filed a Motion for Summary Judgment on January 24,
2018. On June 21, 2018, the Court ruled in favor of the Company on
some issues and determined that other issues warranted a trial. As
part of its ruling on the Motion for Summary Judgment, the Court
held "While it seems likely that Plaintiff did suffer some amount
of damages, Plaintiff has so far failed to provide a sufficient
evidentiary foundation from which the trier of fact could
reasonably calculate the value of its injury." The Court stated
that it was "reasonably certain that Plaintiff suffered some
damage" and found that Pulse Health "may be entitled to nominal
damages." The Court further determined that equitable relief, such
as an injunction, "may be warranted." Following such rulings, the
Company discovered certain deficiencies in its discovery responses
and is taking the appropriate steps to supplement the record and
correct these deficiencies. In addition, the Court has ordered a
settlement conference in front of a U.S. magistrate to be held on
August 31, 2018. Trial has been set for November 13, 2018 in
Portland, Oregon.
On or about June 15, 2018, certain parties brought certain class
action lawsuits against the Company.
Faulkner v. Akers Biosciences, Inc., No. 2:18-cv-10521
(D.N.J.)
On June 13, 2018, Plaintiff Tim Faulkner filed a class action
complaint alleging securities violations against Akers Biosciences,
Inc. ("Akers"), John J. Gormally, and Gary M. Rauch ("Individual
Defendants") (together with Akers, "Defendants") on behalf of all
persons and entities who purchased publicly traded Akers securities
from May 15, 2017 through June 5, 2018. The complaint alleges
violations of Section 10(b) of the Exchange Act and Rule 10b-5
against all Defendants, and violations of Section 20(a) of the
Exchange Act against the Individual Defendants. In particular, the
complaint alleges that Defendants made false and/or misleading
statements and/or failed to disclose in its first, second, and
third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was
improperly recognizing revenue for the fiscal year ended December
31, 2017; and, (2) Akers had downplayed weaknesses in its internal
controls over financial reporting and failed to disclose the true
extent of those weaknesses. On July 10, 2018, Plaintiff and
Defendants entered into a stipulation that Defendants are not
required to respond to the complaint until the court appoints a
lead plaintiff and lead counsel for the class, and then after the
lead plaintiff chooses whether to file an amended complaint or
whether to designate the complaint as the operative complaint.
Gleason v. Akers Biosciences, Inc., No. 2:18-cv-10805
(D.N.J.)
On June 20, 2018, Plaintiff David Gleason filed a class action
complaint alleging securities violations against Akers Biosciences,
Inc. ("Akers"), John J. Gormally, and Gary M. Rauch ("Individual
Defendants") (together with Akers, "Defendants") on behalf of all
persons and entities who purchased publicly traded Akers securities
from May 15, 2017 through June 5, 2018. The complaint alleges
violations of Section 10(b) of the Exchange Act and Rule 10b-5
against all Defendants, and violations of Section 20(a) of the
Exchange Act against the Individual Defendants. In particular, the
complaint alleges that Defendants made false and/or misleading
statements and/or failed to disclose in its first, second, and
third quarter 2017 10-Qs and its 2017 10-K that: (1) Akers was
improperly recognizing revenue for the fiscal year ended December
31, 2017; and, (2) Akers had downplayed weaknesses in its internal
controls over financial reporting and failed to disclose the true
extent of those weaknesses. No Defendant has been served yet, and
no response is due at this time.
Other class action lawsuits have been threatened against the
Company and may be filed shortly. Although there are currently two
separate actions pending, we anticipate that the two actions will
be consolidated into one action.
The Company maintains D&O liability insurance coverage,
insuring both the Company and the Directors and Officers for
covered defense and indemnification, and has noticed these matters
thereunder.
Additionally, a former executive has threatened to sue the
Company, Board members, and executives under CEPA over the
termination of his employment. That statute prohibits any
retaliatory action against an employee who discloses, or threatens
to disclose to a supervisor or to a public entity any activity,
policy or practice of the employer that is a violation of a law, or
a rule or regulation. Remedies may include a counter claim for back
pay, reinstatement, compensatory and punitive damages and
attorneys' fees if appropriate. The Company will vigorously defend
any litigation brought by this former executive.
The Company intends to establish a rigorous defense of all
claims. The Company is unable to assess the potential outcome, so
no accrual for losses was made as of June 30, 2018. All legal fees
were expensed as and when incurred.
With the exception of the foregoing, we are not currently
involved in any litigation that we believe could have a materially
adverse effect on our financial condition or results of operations.
There is no action, suit, proceeding, inquiry or investigation
before or by any court, public Board, government agency,
self-regulatory organization or body pending or, to the knowledge
of the executive officers of our Company, threatened against or
affecting our Company or our Common Stock, in which an adverse
decision could have a material adverse effect.
Item 1A. Risk Factors
In addition to the risk factors in our Annual Report on Form
10-K/A, Amendment No. 1, filed with the SEC on July 13, 2018,
please see additional risk factors provided below.
The market price of our common stock is likely to be volatile
and could subject us to litigation.
The market price of our common stock is likely to be highly
volatile and could be subject to wide fluctuations in response to a
number of factors that are beyond our control, including, but not
limited to:
-- variations in our revenue and operating expenses;
-- actual or anticipated changes in the estimates of our operating results or changes in stock
market analyst recommendations regarding our ordinary shares, other comparable companies or
our industry generally;
-- market conditions in our industry and the economy as a whole;
-- developments in the financial markets and worldwide or regional economies;
-- announcements of innovations or new products or services by us or our competitors;
-- announcements by the government relating to regulations that govern our industry;
-- sales of our common stock or other securities by us or in the open market;
-- recruitment or departure of key personnel;
-- any actions taken against the Company by former executives;
-- Potential delisting from the NASDAQ Stock Market;
-- any class action lawsuits brought against the Company; and
-- changes in the market valuations of other comparable companies
In addition, if the market for biotech stocks or the stock
market in general experiences loss of investor confidence, the
trading price of our common stock could decline for reasons
unrelated to our business, financial condition or operating
results. The trading price of our shares might also decline in
reaction to events that affect other companies in our industry,
even if these events do not directly affect us. Each of these
factors, among others, could harm the value of your investment in
our common stock. In the past, following periods of volatility in
the market, securities class-action litigation has often been
instituted against companies. Such litigation, if instituted
against us, could result in substantial costs and diversion of
management's attention and resources, which could materially and
adversely affect our business, operating results and financial
condition. Specifically, on or about June 15, 2018, certain parties
have brought certain class action lawsuits against the Company, and
a former executive has threatened to sue the Company, Board
members, and executives under the New Jersey CEPA, N.J. Stat. Ann.
-- 34-19.1 over the termination of his employment. Both, the class
action lawsuits brought against the Company and CEPA action
threatened by a former executive could result in substantial costs
and diversion of management's attention and resources, which could
harm the value of your investment in our common stock and
materially and adversely affect our business, operating results and
financial condition.
A robust public market for our common stock may not develop or
be sustained, which could affect your ability to sell our common
stock or depress the market price of our common stock.
Our common stock is listed on NASDAQ, but we cannot assure you
that our common stock will continue to trade on this market or
another national securities exchange. In addition, we are unable to
predict whether an active trading market for our common stock will
develop or will be sustained.
By way of a letter dated May 22, 2018, the Listing
Qualifications Department of the NASDAQ advised the Company that it
did not comply with NASDAQ Listing Rule 5250(c)(1) for continued
listing because NASDAQ has not received the Company's Quarterly
Report. NASDAQ has informed the Company that the Company is
required to submit a plan to regain compliance with NASDAQ's filing
requirements for continued listing within 60 calendar days of the
date of the Notice. NASDAQ has informed the Company that it is in
Compliance with NASDAQ Listing Rule 5250(c)(1) on July 12,
2018.
On June 11, 2018, the Company received a letter from the Listing
Qualifications Department NASDAQ notifying the Company that it has
determined that the Company violated the shareholder approval
requirements of Listing Rule 5635(c). Listing Rule 5635(c) requires
shareholder approval prior to the issuance of securities when a
stock option or purchase plan is to be established or materially
amended or other equity compensation arrangement made or materially
amended, pursuant to which stock may be acquired by officers,
directors, employees or consultants.
Prior to the Company's public offering and listing on NASDAQ,
the Company's 2013 Plan was approved by its Board NASDAQ has
concluded that the 2013 Plan was materially amended on two
occasions after the Company's public offering and listing on
NASDAQ. The first amendment, as approved by the Board on January 9,
2015, increased the number of shares available under the 2013 Plan
from 400,000 to 800,000 shares and the second amendment, as
approved by the Board on October 5, 2016, increased the number of
shares under the 2013 Plan from 800,000 to 830,000 shares. The
Company has until December 10, 2018, to regain compliance with
Listing Rule 5635.
During the first quarter of 2018 the Company promptly notified
NASDAQ, as required by Listing Rule 5625, when it became aware of
its potential non-compliance with Listing Rule 5635(c). On May 4,
2018, the Staff requested additional information from the Company
with respect to such non-compliance and on May 31, 2018, the
Company responded. On June 25, 2018, the Company submitted the 5635
Compliance Plan to NASDAQ to remediate this matter. The 5635
Compliance Plan included that a proposal for shareholders of the
Company to ratify the 2013 Plan Amendments be included in the proxy
statement for the Company's 2018 annual meeting of the shareholders
of the Company and that the Company shall suspend the trading of
each share granted, and each share granted upon the exercise of any
option granted, in excess of 400,000 shares under the 2013 Plan
(the number of shares properly approved pursuant to the 2013 Plan
prior to the 2013 Plan Amendments). The 5635 Compliance Plan also
proposes to prevent the exercise of any option granted under the
2013 Plan.
If NASDAQ (i) does not believe that the filing of this Quarterly
Report and the Amended Quarterly and Annual Reports as discussed
above have cured the potential default as to the Company meeting
the requirements to continue its listing in good standing under
NASDAQ, or (ii) does not find that the 5635 Compliance Plan
acceptable to cure the Company's violation of Listing Rule 5635(c),
then we cannot assure you that our common stock will continue to
trade on this market or another national securities exchange.
The restatement of our previously issued financial statements
contained in our Forms 10-Q for the periods ended June 30, 2017 and
September 30, 2017 and the Form 10-K for the year ended December
31, 2017 may lead to additional risks and uncertainties, including
regulatory, stockholder or other actions, loss of investor
confidence and negative impacts on our stock price.
Our Audit Committee, after consultation with management and
discussing with outside counsel, external auditors and third-party
consultants, concluded that our previously issued consolidated
financial statements for the quarterly periods ended June 30, 2017
and September 30, 2017 and for the year ended December 31, 2017
should be restated. The Company determined that certain revenue
transactions did not qualify for revenue recognition under
generally accepted accounting principles, that certain obligations
were not recorded as expenses on a timely basis and that the
Company did not properly value its inventory. The Company concluded
that the impact of applying corrections for these errors was
materially different from its previously reported results under its
historical practice. As a result, the Company restated its
consolidated financial statements for the periods impacted, as more
fully described within each of the respective amended reports, as
filed on July 13, 2018. Financial information included in our
previously filed Form 10-K and our Quarterly Reports on Form 10-Q
and all earnings press releases and similar communications issued
by us, for such periods, should not be relied upon and are
superseded in their entirety by the above described amended
Quarterly and Annual reports.
Accordingly, this Form 10-Q reflects: (1) changes to our
Condensed Consolidated Balance Sheet and our Condensed Consolidated
Statements of Shareholders' Equity as of December 31, 2017; (2)
expanded risk factor disclosures within Part II, Item 1A, and (3)
additional disclosures and conclusions regarding Controls and
Procedures in Part II, Item 4.
As a result of the 2017 restatements and associated non-reliance
on previously issued financial information, we have become subject
to a number of additional costs and risks, including unanticipated
costs for accounting and legal fees in connection with or related
to the restatement and the remediation of our ineffective
disclosure controls and procedures and material weakness in
internal control over financial reporting. Likewise, the attention
of our management team has been diverted by these efforts. In
addition, we could also be subject to additional shareholder,
governmental, regulatory or other actions or demands in connection
with the restatement or other matters. Any such proceedings will,
regardless of the outcome, consume a significant amount of
management's time and attention and may result in additional legal,
accounting, insurance and other costs. If we do not prevail in any
such proceedings, we could be required to pay damages or settlement
costs. In addition, the restatement and related matters could
impair our reputation or could cause our customers, shareholders,
or other counterparties to lose confidence in us. Any of these
occurrences could have a material adverse effect on our business,
results of operations, financial condition and stock price.
In connection with the restatement of our financial statements
for the quarterly periods ended June 30, 2017 and September 30,
2017 and for the year ended December 31, 2017, our management
identified material weaknesses in our internal control over
financial reporting, as described in Item 9A, "Control and
Procedures" of this Form 10-K. A material weakness is a deficiency,
or combination of deficiencies in internal controls over financial
reporting that results in a reasonable possibility that a material
misstatement of our annual or interim financial statements will not
be prevented or detected on a timely basis. Further, management
determined that control deficiencies existed with respect to
certain aspects of our historical financial reporting and,
accordingly, management has concluded that management's reports
related to the effectiveness of internal and disclosure controls
may not have been correct.
A deterioration of global economic conditions may adversely
affect our industry, business and results of operations.
Disruptions in the global credit and financial markets and in
economic conditions generally may include diminished liquidity and
credit availability, a decline in consumer confidence, a decline in
economic growth, an increased unemployment rate and uncertainty
about economic stability. Such disruptions may affect businesses
such as ours in a number of ways, making it difficult to accurately
forecast and plan our future business activities. Any adverse
global economic conditions and tightening of credit in financial
markets may lead consumers to postpone spending, which may cause
our customers to cancel, decrease or delay their existing and
future orders with us. In addition, financial difficulties
experienced by our suppliers, manufacturers, distributors or
customers could result in product delays, increased accounts
receivable defaults and inventory challenges. We are unable to
predict the likely duration and severity of disruptions in the
credit and financial markets and adverse global economic
conditions.
Our ability to grow and compete in the future will be adversely
affected if adequate capital is not available to us or not
available on terms favorable to us.
Historically, our cash generated from operations has not been
sufficient to meet our expenses. We have financed our operations
principally through the raising of equity capital, debt and through
trade credit with our vendors. Our ability to continue our
operations and to pay our obligations when they become due is
contingent upon obtaining additional financing. If we are unable to
obtain sufficient amounts of additional capital, we may be required
to reduce the scope of our planned market development activities,
and/or consider reductions in personnel costs or other operating
costs. These conditions raise substantial doubt about the Company's
ability to continue as a going concern.
Obligations associated with being a public company require
significant company resources and management attention, which may
have a material adverse effect on our financial condition and
results of operations.
We are subject to the reporting requirements of the Securities
Exchange Act of 1934, as amended, or the "Exchange Act," and the
other rules and regulations of the SEC, including the
Sarbanes-Oxley Act. The Exchange Act requires, among other things,
that we file annual, quarterly and current reports with respect to
our business and financial condition and the Sarbanes-Oxley Act
requires, among other things, that we maintain effective disclosure
controls and procedures and internal control over financial
reporting. These reporting and other obligations place significant
demands on our management, administrative, operational and
accounting resources, make certain activities more time-consuming
and cause us to incur significant legal, accounting and other
expenses. In order to comply with these obligations, we may need to
upgrade our systems or create new systems, implement additional
financial and management controls, reporting systems and
procedures, expand or outsource our internal audit function, and
hire additional accounting and finance staff. Because our resources
are limited compared to many public companies, these requirement
may impose a disproportionate financial burden on us. Furthermore,
our limited management resources may exacerbate the difficulties in
complying with these reporting and other requirements and prevent
us from focusing on executing our business strategy. In addition,
if we are unable to comply with the financial reporting
requirements and other rules that apply to reporting companies, the
market price of our common stock could be adversely affected.
As an "emerging growth company" and a "smaller reporting
company" we intend to continue to take advantage of certain
exemptions from various reporting requirements that are applicable
to other public companies that are not "emerging growth companies"
or "smaller reporting companies," including, but not limited to,
not being required to comply with the auditor attestation
requirements of Section 404 of the Sarbanes-Oxley Act, reduced
disclosure obligations regarding executive compensation in our
periodic reports and proxy statements and other scaled disclosure
requirements, and exemptions from the requirements of holding a
nonbinding advisory vote on executive compensation and stockholder
approval of any golden parachute payments not previously approved.
In general, we will remain an "emerging growth company" until
December 31, 2020, although a variety of circumstances could cause
us to lose that status earlier, and will remain a "smaller
reporting company" for each fiscal year where our public float
remains below $75 million as of the last day of the second fiscal
quarter of the prior fiscal year. We intend to take advantage of
some or all of these exemptions and reduced reporting requirements
until we are no longer an "emerging growth company" and/or a
"smaller reporting company," at which time, we expect to incur
significant additional expenses and devote substantial management
effort toward ensuring compliance with these additional
requirements.
The Company's business would suffer if the Company were unable
to acquire adequate sources of supply.
We use a diverse and broad range of raw materials in the
manufacturing of our products. We purchase all of our raw materials
and select items, such as packaging, from external suppliers. In
addition, we purchase some supplies from single sources for reasons
of proprietary know-how, quality assurance, sole source
availability, or due to regulatory qualification requirements and
disruption of these sources could have, at a minimum, a temporary
adverse effect on shipments and the financial results of the
Company. We work closely with our suppliers to ensure continuity of
supply while maintaining high quality and reliability. Any
prolonged inability to obtain certain materials or components could
have an adverse effect on the Company's financial condition or
results of operations and could result in damage to its
relationships with its customers and, accordingly, adversely affect
the Company's business.
During the six months ended June 30, 2018, we experienced lower
yields in the process of extracting antigen from the supplier
provided platelets used to produce our PIFA Heparin product. At
these yield levels, our production of this product was under target
levels, resulting in backorders. Our engineers and representatives
from our supplier have been working together to adjust our
processes in order to restore the yield to appropriate levels, the
results of which are not yet determined. Furthermore, we are
evaluating and testing a solution that may involve one or more
alternative antigen suppliers and processes that may provide a path
to restoring yield levels for this product.
Negotiations are underway with multiple customers for the
Company's products and are anticipated to be completed in the near
term, but a significant delay will impact revenue projections.
In May 2018, after extensive review both internally and with the
FDA, we withdrew our initial 510(k) application for the PIFA
Chlamydia rapid assay. We are currently evaluating the feasibility
and marketability of this product in order to determine when and if
the 510(k) application will be resubmitted.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
There were no unregistered sales of the Company's equity
securities during the quarter ended June 30, 2018, other than those
previously reported in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities
There has been no default in the payment of principal, interest,
sinking or purchase fund installment, or any other material
default, with respect to any indebtedness of the Company.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information.
There have been no material changes to the Other Information
previously disclosed in Part II, Item 1A of our Quarterly Report on
Form 10-Q, filed with the SEC on July 13, 2018.
Item 6. Exhibits.
31.1 Certification by the Principal Executive Officer of Registrant pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002 (Rule 13a-14(a) or Rule 15d-14(a)). *
31.2 Certification by the Principal Financial Officer of Registrant pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002 (Rule 13a-14(a) or Rule 15d-14(a)). *
32.1 Certification by the Principal Executive Officer pursuant to 18 U.S.C. 1350 as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. *
32.2 Certification by the Principal Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002. *
101.INS XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema
101.CAL XBRL Taxonomy Extension Calculation Linkbase
101.DEF XBRL Taxonomy Extension Definition Linkbase
101.LAB XBRL Taxonomy Extension Label Linkbase
101.PRE XBRL Taxonomy Extension Presentation Linkbase
* Filed herewith
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the
Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
AKERS BIOSCIENCES, INC.
Date: August 14, 2018 By: /s/ John J. Gormally
-----------------------------------
Name: John J. Gormally
Title: Chief Executive Officer
(Principal Executive Officer)
Date: August 14, 2018 By: /s/ Gary M. Rauch
-----------------------------------
Name: Gary M. Rauch
Title: Vice President, Finance & Treasurer
(Principal Financial Officer)
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, John J. Gormally, certify that:
1. I have reviewed this Form 10-Q of Akers Biosciences, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by
this report;
3. Based on my knowledge, the financial statements, and other financial information included
in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e))
and internal control over financial reporting (as defined in Exchange Act Rules 13-a-15(f)
and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures
to be designed under our supervision, to ensure that material information relating to the
registrant, including its consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over
financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented
in this report our conclusions about the effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant's internal control over financial reporting
that occurred during the registrant's most recent fiscal quarter (the registrant's fourth
fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrant's auditors and
the audit committee of the registrant's Board of Directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrant's
ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrant's internal control over financial reporting.
Date: August 14, 2018 By: /s/ John J. Gormally
---------------------------
John J. Gormally
Principal Executive Officer
Akers Biosciences, Inc.
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Gary M. Rauch, certify that:
1. I have reviewed this Form 10-Q of Akers Biosciences, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by
this report;
3. Based on my knowledge, the financial statements, and other financial information included
in this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e))
and internal control over financial reporting (as defined in Exchange Act Rules 13-a-15(f)
and 15d-15(f)) for the registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures
to be designed under our supervision, to ensure that material information relating to the
registrant, including its consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over
financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented
in this report our conclusions about the effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant's internal control over financial reporting
that occurred during the registrant's most recent fiscal quarter (the registrant's fourth
fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrant's auditors and
the audit committee of the registrant's Board of Directors (or persons performing the equivalent
functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrant's
ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrant's internal control over financial reporting.
Date: August 14, 2018 By: /s/ Gary M. Rauch
---------------------------
Gary M. Rauch
Principal Financial Officer
Akers Biosciences, Inc.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report of Akers Biosciences,
Inc. (the "Company"), on Form 10-Q for the period ended June 30,
2018, as filed with the U.S. Securities and Exchange Commission on
the date hereof, I, John J. Gormally, Principal Executive Officer
of the Company, certify to the best of my knowledge, pursuant to 18
U.S.C. Sec. 1350, as adopted pursuant to Sec. 906 of the
Sarbanes-Oxley Act of 2002, that:
(1) Such Quarterly Report on Form 10-Q for the period ended June 30, 2018, fully complies with
the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in such Quarterly Report on Form 10-Q for the period ended June
30, 2018, 2018, fairly presents, in all material respects, the financial condition and results
of operations of the Company.
Date: August 14, 2018 By: /s/ John J. Gormally
---------------------------
John J. Gormally
Principal Executive Officer
Akers Biosciences, Inc.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report of Akers Biosciences,
Inc. (the "Company"), on Form 10-Q for the period ended June 30,
2018, as filed with the U.S. Securities and Exchange Commission on
the date hereof, I, Gary M. Rauch, Principal Financial Officer of
the Company, certify to the best of my knowledge, pursuant to 18
U.S.C. Sec. 1350, as adopted pursuant to Sec. 906 of the
Sarbanes-Oxley Act of 2002, that:
(1) Such Quarterly Report on Form 10-Q for the period ended June 30, 2018, fully complies with
the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in such Quarterly Report on Form 10-Q for the period ended June
30, 2018, fairly presents, in all material respects, the financial condition and results of
operations of the Company.
Date: August 14, 2018 By: /s/ Gary M. Rauch
---------------------------
Gary M. Rauch
Principal Financial Officer
Akers Biosciences, Inc.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
IR DGGDIIUBBGIS
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