Akers Biosciences, Inc.
Annual Report and Accounts 2015
2016
CURRENT
TRADING
Company performing well
in 2016 with orders for
rapid heparin allergy tests
already exceeding
$3 million in the current
year
Sales of rapid heparin
allergy tests into
US hospitals in Q1 are
up 70% over the same
quarter in 2015
2015 Highlights
FINANCIAL
12% increase in US sales of flagship
heparin allergy test to $1,391,017
(2014: $1,241,406)
Total revenue declined to $2,115,050
(2014: $4,427,174), partly due to
deferment of certain international orders
into 2016 - received in Q1 2016
Net cash loss from operations of
$5,132,343 (2014: loss of $3,883,929)
Total loss of $9,311,913 (2014: loss of
$3,142,960) substantially increased by
non-cash and non-recurring items totaling
approximately $4.7 million
Maintaining liquid balance sheet with cash
and marketable securities of $4,427,163
(2014: $9,720,802)
US sales of
heparin
allergy test
+12%
OPERATIONAL
Significant operational and regulatory
approval progress achieved in China
laying the groundwork for Chinese sales to
commence this year
China Food and Drug Administration
approved the Company’s rapid heparin
allergy test leading to $2.5 million of
placed orders for 2016 to date
Chinese production facility completed and
made fully operational
In addition to the rapid heparin allergy
test, marketing commenced in China for
four breath tests focused on the major
markets of diabetes, weight loss, fitness
and alcohol
Introduced new Akers Wellness product
line targeting large and growing market
for personalized health - including app-
enabled tests for monitoring and tracking
personal health over time
Expanded global distribution network for
rapid heparin allergy test providing access
to all major diagnostic markets
Appointed a new, highly experienced CEO
to drive product commercialization - impact
already showing in strong US sales in Q1
2016 for the Company’s rapid heparin
allergy tests
European Patent Office issued a patent
surrounding the Company’s novel blood
separator technology and method of
separating a fluid fraction from whole
blood
Achieved ISO 13485 certification of quality
management system enabling acceleration
of regulatory approval process for the
Company’s products in certain countries
Chairman’s Statement
2015 was principally about augmenting the senior commercial
team, refining the execution strategy, laying the groundwork for
entry into China and developing a product suite to target the huge
personalized health and wellness market. I am pleased to say
that this preparatory work in 2015 is already paying off in 2016
with orders for our rapid heparin allergy tests already exceeding
$3 million in the current year.
We already have sufficient visibility from the first twelve weeks
of the year in our core heparin allergy test business to know
that sales are materially outperforming last year’s. Not only is
this being driven by orders from China but it is also coming from
improvements in our domestic US business. We hope to see this
trend continue as the full impact of our new commercial team and
execution strategy begins to be felt.
Substantial work was undertaken in 2015 to prepare for market
entry into China. In November we received clearance from
the China Food and Drug Administration for our flagship rapid
heparin allergy test which led to our Chinese distributor placing
$2.5 million worth of orders for 2016. Furthermore, we worked
extensively in 2015 with our Chinese joint venture partners to
establish a first class manufacturing facility in Hainan province
which is now fully operational. It is envisaged that the majority
of Akers’ products for sale into China will be manufactured in-
country leading to significant commercial benefits. Marketing
in China commenced for four of our breath tests in the prolific
areas of diabetes, weight loss, fitness and alcohol. The
Chinese healthcare system has identified the critical need to
address soaring obesity rates and a diabetes epidemic which
highlights the compelling opportunity to introduce Akers’ simple,
inexpensive breath-based tests in these areas.
While not yet generating significant revenue, the Company has
developed and introduced three transformational breath tests
designed for the health and wellness industry and consumers
during 2015. These include the consumer-focused METRON®, as
well as the BreathScan OxiChek™ (“OxiChek”) and BreathScan
KetoChek™ (“KetoChek”) tests which work with a new bluetooth-
enabled reading device, BreathScan Lync™ and its associated
BreathScan™ mobile app, to enable consumers and professional
users to monitor trends in health via a mobile device. Being able
to generate near-instant health information is, I believe, key to
the future of medicine. With our Akers Wellness tests, clinicians,
suppliers of nutritional supplements and diet plans, health
coaches or even consumers themselves, can now monitor their
- or their clients’ - health over time by utilizing Akers Wellness
products.
Raymond F. Akers, Jr. PhD, Co-founder and Execuive Chairman
“The preparatory work in 2015
is already paying off in 2016 with
orders for our rapid heparin allergy
tests already exceeding $3 million in
the current year.”
Towards the end of last year I was delighted to welcome
a new CEO to focus entirely on product and technology
commercialization. The commercial team is being further
strengthened with a number of new senior hires and the improved
execution of our US heparin allergy test sales strategy has led
to encouraging early sales indicators from the first twelve weeks
of this year. I am very excited about the team we are building at
Akers Bio.
Looking ahead through 2016, we have had a tremendous start
to the year with the receipt of $2.5 million worth of orders from
China (with initial sales expected imminently) and approximately
$600,000 worth of sales of tests into US hospitals already
recorded in Q1 - an increase of 70% over the same quarter in
2015. We hope to see a continuing upward trajectory in the
US heparin allergy test business and look forward to seeing
meaningful contributions beginning to flow through again from
our alcohol breathalyzers and from the newly launched Akers
Wellness line.
Raymond F. Akers, Jr. PhD
Co-founder and
Executive Chairman
March 30, 2016
With the development for the Akers Wellness line now largely
completed, the focus has turned to marketing and sales
execution, and we look forward to reporting on progress in these
areaslater this year.
In February, the Company’s Management System was certified
to ISO 13485. The certification is a requirement in certain
countries to enable regulatory approval of medical devices, so it
an extremely important asset when seeking accelerated product
clearance in certain countries.
Another regulatory milestone achieved in 2015 was the European
Patent Office’s issuance of a patent surrounding the Company’s
novel blood separator technology and method of separating a
fluid fraction from whole blood. We now have patent protection
both in the US and Europe enabling Akers to incorporate the
technology into certain of our blood-based assays where the
speed of our test is paramount to clinical decision making. It may
also enable the Company in the future to offer the technology
under license to third parties seeking to accelerate their own
testing procedures by facilitating the blood cell separation
process as a component of their test.
Multiple new distribution agreements outside of the US were
signed in 2015 giving the Company access to every major
diagnostic market in the world. The primary drivers of this
distribution network are the Company’s flagship rapid heparin
allergy tests, and we are supporting our distribution partners’
efforts to introduce these tests in their respective territories.
Additionally, the Company’s BreathScan® Alcohol Detector
continues to generate interest through our international
distribution network with sales to the EU and South Africa
contributing to revenues in 2015.
“Substantial work was undertaken in
2015 to prepare for market entry into
China, which led to our Chinese
distributor placing $2.5 million
worth of orders for 2016.”
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Fiscal Year Ended: December 31, 2015
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
AKERS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
New Jersey
(State or other jurisdiction of
incorporation or organization)
(Commission
File Number)
22-2983783
(I.R.S. Employer
Identification Number)
201 Grove Road
Thorofare, New Jersey USA 08086
(Address of principal executive offices, including zip code)
(856) 848-8698
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock, no par value
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 the Securities Act. Yes [ ] No [X]
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes [ ] No
[X]
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 preceding 12 months (or for such shorter period that the registrant was required to file such reports)
and (2) has been subject to such filing requirements for the last 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 (§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 if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not
contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. Yes [ ] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of
the Exchange Act.
Large Accelerated Filer [ ]
Accelerated Filer [ ]
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Non-Accelerated Filer [ ]
Smaller reporting company [X]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X]
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant on June 30, 2015,
based on a closing price of $4.35 was $22,380,041. As of March 25, 2016, the registrant had 5,425,045 shares of its common stock, no
par value per share, outstanding.
Documents Incorporated By Reference: None.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC.
FOR THE FISCAL YEAR ENDED
DECEMBER 31, 2015
TABLE OF CONTENTS
PART
I
Business.
Risk Factors.
Unresolved Staff Comments.
Properties.
Legal Proceedings.
Mine Safety Disclosures.
Item
1.
Item
1A.
Item
1B.
Item
2.
Item
3.
Item
4.
PART
II
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Selected Financial Data.
Management’s Discussion and Analysis of Financial Condition and Results Of Operations.
Quantitative And Qualitative Disclosures About Market Risk.
Financial Statements and Supplementary Data.
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
Controls and Procedures.
Other Information.
Item
5.
Item
6.
Item
7.
Item
7A.
Item
8.
Item
9.
Item
9A.
Item
9B.
PART
III
Directors, Executive Officers and Corporate Governance.
Executive Compensation.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
Certain Relationships and Related Transactions, and Director Independence.
Item
10.
Item
11.
Item
12.
Item
13.
Page
3
19
39
39
39
39
40
42
42
53
53
53
53
54
55
61
64
65
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Principal Accounting Fees and Services.
Item
14.
PART
IV
Exhibits, Financial Statement Schedules.
Item
15.
2
66
67
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
FORWARD LOOKING STATEMENTS
Included in this Form 10-K are “forward-looking” statements, as well as historical information. Although we believe that the
expectations reflected in these forward-looking statements are reasonable, we cannot assure you that the expectations reflected in these
forward-looking statements will prove to be correct. Our actual results could differ materially from those anticipated in
forward-looking statements as a result of certain factors, including matters described in the section titled “Risk Factors.”
Forward-looking statements include those that use forward-looking terminology, such as the words “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “project,” “plan,” “will,” “shall,” “should,” and similar expressions, including when used in the negative.
Although we believe that the expectations reflected in these forward-looking statements are reasonable and achievable, these
statements involve risks and uncertainties and we cannot assure you that actual results will be consistent with these forward-looking
statements. We undertake no obligation to update or revise these forward-looking statements, whether to reflect events or
circumstances after the date initially filed or published, to reflect the occurrence of unanticipated events or otherwise.
PART I
Item 1. Business.
Overview
Akers Biosciences, Inc. (“Akers,” “we” or the “Company”) 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 time- and cost-efficient manner.
Akers believes it has advanced the science of diagnostics through the development of several innovative 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 total outcome costs of healthcare. The Company’s current product offerings and pipeline products focus on delivering
including cardiology/emergency medicine,
diagnostic assistance
metabolism/nutrition, diabetes, respiratory diseases and infectious diseases detection, as well as for on and off-the-job alcohol safety
initiatives.
in a wide variety of healthcare
fields/specialties,
Akers believes that low-cost, unit-use testing not only saves time and money, but allows for more frequent, near-patient testing which
may save lives. We believe that Akers’ FDA-cleared rapid diagnostic tests help facilitate targeted diagnoses and real-time treatment.
We also believe that Akers’ 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 easy to use, accurate at-home tests for individuals to monitor their personal health and wellness;
need for affordable mass screening tests for key infectious diseases, cardiac conditions, and metabolic markers; and
public health needs in developing countries lacking basic health infrastructure.
Recently, the Company has developed tests for non-medical use within the health and wellness industry. These tests will monitor
general markers of health and wellness as they relate to diet, nutrition and exercise programs.
3
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Market Overview
Worldwide, healthcare professionals use laboratory tests to support their clinical diagnosis and treatment decisions. According to a
MarketsandMarkets report, In-Vitro Diagnostic (IVD) Market (Applications, End-users & Types) Trends & Global Forecasts (Major
& Emerging Markets - G7, Japan & BRIC) (2011 - 2016) , published in January 2012 (the “IVD Market Report”), the use of such
tests continues to grow as a result of increased patient awareness, patient self-testing, and the aging baby boomer population across the
globe. Other major drivers for the growth of the in vitro diagnostic (“IVD”) industry is a rise in the number of diseases like
respiratory and hospital-acquired infections and a rise in the chronic diseases such as diabetes, hypertension, cardiovascular diseases,
and cancer. Both an increasing understanding of the molecular processes underlying many disease states and the opportunity for
clinicians to quickly incorporate that targeted information into treatment decisions (e.g. companion testing). According to an article
published on in vitro diagnostics by Medical Device and Diagnostic Industry (“MDDI”) online in March 2013, in the past, the in
vitro diagnostics industry has focused on developing tests that require significant time, skill, and often costly, specialized equipment.
Patient specimens often had to be collected remotely and processed in a central laboratory with test results sent to a physician at a later
date. This general protocol is not particularly well-adapted to the practice of medicine in a cost-effective, timely manner. The
pressures on public health budgets and falling profits among third party payors such as insurers, necessitates an alternative approach to
disease management. Moreover, the implementation of “Obamacare” in the United States mandates that tens of millions of additional
people receive cost-effective healthcare. This reality has changed the American healthcare landscape as evidenced by the steady
growth of the retail health clinic and urgent care center markets.
According to the IVD Market Report, outside of the United States, socialized medicine and/or a general atmosphere of
cost-containment and healthcare efficiency are driving the need for diagnostic testing solutions that are fast, affordable, accurate,
simple-to-perform and help enable early diagnosis and treatment of medical conditions or provide an assessment of a person’s health
status.
Akers designed its products based on single-use assay platforms with straightforward test procedures that can be completed in
minutes. In the healthcare setting, the Company’s clinical laboratory products can be utilized near or at the point-of-care and do not
require the use of expensive equipment or a highly trained or specialized staff. As a result, an individual’s current health status can
immediately be incorporated into diagnostic and treatment decisions, improving the overall efficiency of the healthcare experience in
the eyes of the patient, and ultimately the payor. In addition, in the developing world, the portability and ease-of-use of such
point-of-care tests can serve to drastically improve the level of disease screening and subsequent patient care. We believe the benefits
of our technology platforms are therefore well-suited to the diagnostic demands of third world countries that seek to deliver modern
medical diagnosis in the midst of primitive infrastructures. In addition, some of our products have received FDA clearance for
over-the-counter use and others that do not fall within the oversight of regulatory authorities have the added benefit of being self-tests
that deliver personal health information on-demand. Akers believes that the products that emerge from its technology platforms
address the needs of the evolving healthcare delivery system that is moving patient care closer to or in the home.
In a June 6, 2013 article, “Global In Vitro Diagnostics Markets Outpace Pharma Industry Growth” by Frost & Sullivan estimated the
global IVD market was $45 billion, with forecasted revenue expected to reach $64 billion in 2017. While the U.S. and Western
Europe are the largest IVD markets, the Asian-Pacific region and Eastern Europe are projected to be the fastest growing by Frost &
Sullivan. The Company’s main presence is in the United States, but recently executed joint venture, distribution and licensing
agreements have initiated Akers’ strategic move to the China and European Union marketplaces.
Strategy
Akers’ strategy is to target carefully chosen, high margin market segments within the diagnostics industry where existing tests do not
effectively fulfill clinical requirements, or an emerging, unfulfilled need has been identified. The Company seeks to develop tests for
applications based on their ability to compliment a particular treatment, lifestyle or testing regimen that requires a time and
cost-efficient diagnostic alternative or solution. Akers utilizes its existing platform technologies to internally develop its new products
as the Company’s proprietary methods.
Akers has established and will continue to pursue distribution relationships with high volume, medical and health & wellness product
marketers to maximize its revenue potential, and to be a worldwide competitor in specialized markets within the diagnostics industry.
4
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Akers has developed and continues to develop key strategic relationships with established companies with well-trained technical sales
forces and strong distribution networks in the following key market segments:
●
●
●
●
●
Clinical Laboratories;
Physicians’ Office and Urgent Care Clinics;
Retail;
Nutraceutical Suppliers; and
Military/Government.
The Company plans to target other attractive markets such as aid organizations with purchasing power for rapid infectious disease
tests and other biotechnology companies or pharmaceutical manufacturers that may require companion tests to promote patient
compliance with a medication regimen or facilitate initial screenings to qualify patients for a particular therapy.
Technology Overview
Akers’ proprietary platform technologies merge scientific innovation with user-friendly formats to deliver cost-effective and
time-efficient testing and sample preparation solutions where and when they are needed.
Testing Platform Technologies
MPC Biosensor Technology
MicroParticle Catalyzed Biosensor (“MPC Biosensor”) Technology permits the rapid identification of medical conditions through
biomarkers in exhaled breath. These products contain microparticles that change color when a subject has a positive test result. The
microparticles are coated with recently discovered agents that both decrease the time to result and provide a more defined color
change when appropriate. MPC Biosensor-based products are packaged in small, disposable cartridges through which test subjects can
easily blow for several seconds. In the United States, the MPC Biosensor Technology is protected by three United States patents
pending, covering all MPC Biosensor products such as BreathScan and the Breath PulmoHealth “Check” suite of products. Breath
Ketone “Check” has one US and one international patent granted. In addition, Akers also holds three US, three Australian and three
European Community Design patents for Color Comparison Card technology that users can utilize to interpret detector results.
Particle ImmunoFiltration Assay (PIFA®) Technology
PIFA® technology is an accurate, rapid, immunoassay (a procedure for detecting or measuring specific proteins or other substances
through their properties as antigens or antibodies ) method based on the selective filtration of dyed microparticles coated with antigen
or antibody. The microparticles are combined with a test sample (whole blood, serum, urine or saliva) within a self-contained device.
If a patient tests positive for the antibody or antigen, a binding event will occur and the dyed microparticles will be trapped by a filter
within the device. As a result, the test window will be void of any color. Conversely, if the patient tests negative, the dyed
microparticles will flow freely into the test window. Akers’ PIFA® Technology is currently protected by United States patent
(5,827,749) covering all PIFA tests such as Heparin, Malaria and Chlamydia. Specific to the PIFA Heparin tests, the Company has
one international Patent (JP 4,931,821) granted in force, and three patent applications pending (one US and two international).
5
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
SMC Technology
Synthetic Macrocycle Complex (“SMC”) Technology is a colorimetric testing methodology that pairs a proprietary reagent ( a
substance or mixture for use in chemical analysis or other reactions) with a hand-held, photometric reader that determines the
quantitative level of a therapeutic drug in a patient’s blood sample. The technology also permits the use of whole blood samples
collected from a simple finger stick, making products that use this technology extremely flexible within the healthcare delivery
system.
Rapid Enzymatic Assay
Rapid Enzymatic Assay (“REA”) technology enables the rapid detection of metabolites in blood and urine in assay formats that are
easy-to-use and deliver quantitative or semi-quantitative results. Products that employ REA technology are primarily intended for
pharmaceutical, nutritional and over-the-counter (“OTC”) markets. Akers has three United States patents (8,808,639; 8,003,061;
8,425,859) for this technology covering our Tri-Cholesterol “Check” test, along with one US patent application pending.
minDNA TM Technology
minDNA TM technology facilitates the analysis of DNA, in one minute, by a hand-held photometric reader. A mixture consisting of a
patient’s whole blood specimen and a disposable reagent is exposed to the minDNAnalyzer, a digital hand-held reflectance
photometer. These assays can be utilized at the point of care setting by non-clinical laboratory personnel using finger stick blood
samples, or in the laboratory using EDTA whole blood specimens obtained through venous blood draws. This technology can be
applied to the development of rapid white blood cell count and absolute neutrophil count assays that can monitor side effects of certain
psychiatric and oncology drugs.
Sample Preparation Technology
Rapid Blood Cell Separation Technology
Akers’ Rapid Blood Cell Separation (“Separator”) Technology, marketed under the brand name seraSTAT®, further accelerates the
rate at which a test result is obtained as the often-required sample preparation step is abbreviated drastically. Conventional methods of
blood cell separation are labor-intensive and time-consuming, typically involving blood collection and laboratory personnel, as well as
electrically-powered centrifuges and other specialized equipment. The disposable Separator device requires only a small-volume
blood sample obtained from a time and cost-efficient finger stick procedure or through a venous blood draw. Akers has obtained the
appropriate US FDA regulatory clearances for seraSTAT® as a stand-alone device and the technology is currently integrated into
PIFA PLUSS PF4 devices, and will be utilized in the infectious disease products currently under development. The seraSTAT® Rapid
Blood Cell Separation Technology is currently protected by two United States patents (7,896,167; 8,097,171) and one international
patent (JP 4,885,134), with two additional international patent applications pending.
Product Portfolio
Akers is positioned as a provider of rapid diagnostic solutions that encompass the totality of the point-of-care testing process, from
sample preparation to immediate test result. In addition, we believe we are a pioneer in disposable breath condensate technology, a
testing format that has significant potential given the variety of wellness- and disease-predicting biomarkers present in an exhaled
breath sample.
At present, Akers’ commercialized and emerging product portfolio incorporates four of the Company’s six proprietary platform
testing technologies: PIFA®, MPC Biosensor, REA and Rapid Blood Cell Separation Technology. Directly below, is a discussion of
the products within our current and emerging portfolio that will be segmented by platform.
6
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Akers designed its products based on single-use assay platforms with straightforward test procedures that can be completed in
minutes. In the U.S. some of the Company’s clinical laboratory products and those with medical intended uses generally require
“prescription use” Federal Drug Administration (“FDA”) 510(k) clearance prior to product marketing given that they will be ordered
or used by medical practitioners in the course of his or her professional practice. Despite this categorization, Akers’ professional use
products are still designed for ease of use, can be utilized near or at the point-of-care, and do not require the use of expensive
equipment or a highly trained or specialized staff. As a result, an individual’s current health status can rapidly be incorporated into
diagnostic and treatment decisions, improving the overall efficiency of the healthcare experience in the eyes of the patient, and
ultimately the payer. In addition, in the developing world, the portability and ease-of-use of such point-of-care tests can serve to
drastically improve the level of disease screening and subsequent patient care. We believe the benefits of our technology platforms are
therefore well-suited to the diagnostic demands of countries in the developing world that seek to deliver modern medical diagnosis in
the midst of primitive infrastructures. In addition, some of our products have received FDA 510(k) clearance for over-the-counter
(“OTC”) use. Other self-tests deliver personal health information of a non-medical nature, on-demand, and are not FDA regulated;
these products are still manufactured in compliance with its ISO 13485 quality management system (“QMS-Compliant”). Akers
believes that all its technology platforms and products address the needs of the evolving healthcare delivery system that is moving
patient care closer to or in the home.
The following table sets forth our marketed and current pipeline products, identifies the appropriate “prescription use” or “OTC”
designation and whether the required clearance has been obtained or is still needed prior to product marketing.
Our marketed and emerging products include:
Product
BreathScanTM
Platform
MPC
Marketed/Pipe
line
Marketed
Not
FDA-
regulated;
QMS-
Compliant
Only
FDA
Clearance
Required
Prescription
Use/OTC
OTC
FDA
Clearance
Status
Obtained/Needed
Obtained
Description
Disposable breath
alcohol detector
BreathScan® PRO
MPC
Marketed
OTC
Obtained
Breath Ketone “Check”®
MPC
Pipeline
Prescription
Use
Needed
METRON ®
MPC
Marketed
X
Breath PulmoHealth
“Check”®
MPC
Pipeline
Prescription
Use
Needed
Quantitative breath
alcohol detection
system
Disposable breath
ketone device for
diabetic monitoring
and management of
senile dementia and
Alzheimers disease
patients
Disposable breath
ketone device to
monitor weight loss
A suite of breath
tests for biomarkers
indicating asthma,
chronic obstructive
pulmonary disease
(COPD), and lung
cancer
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
BreathScan Lync
MPC
Marketed
X
7
Non-invasive,
quantitative
measurement of
biological markers
for health and
wellness
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Product
PIFA® Heparin/PF4 & PIFA
PLUSS® PF4
Platform
PIFA
Market/Pipe
line
Marketed
Not
FDA-
regulated;
QMS-
Compliant
Only
FDA
Clearance
Required
Prescription
Use/OTC
Prescription
Use
FDA
Clearance
Status
Obtained/Needed
Obtained
Description
Rapid tests for
Heparin/PF4
antibodies to detect an
allergy to the widely
used blood thinner,
Heparin
PIFA PLUSS® Chlamydia
PIFA
Pipeline
Prescription
Needed
Use
seraSTAT®
seraStat Marketed
Prescription
Obtained
Use
Tri-Cholesterol “Check”®
REA
Marketed
OTC
Obtained
PIFA PLUSS TroponinI
PIFA
Pipeline
Prescription
Needed
Use
Rapid tests for a the
most prevalent
sexually transmitted
disease
Rapid Blood Cell
Separator, marketed
under the brand name
seraSTAT®, further
accelerates the rate at
which a test result is
obtained as the
often-required sample
preparation step is
abbreviated
drastically.
Rapid test for Total
and high density
lipoprotein cholesterol
and estimates low
density lipo protein
Rapid test for the
diagnosis of a
myocardial infarction
MPC Biosensor Technology
The Company’s MPC Biosensor breath condensate testing platform forms the basis of a number of Akers’ marketed and pipeline
products.
Breath Alcohol Franchise
BreathScan® originated the disposable breath alcohol detector category and was the first single-use breathalyzer to obtain the FDA
510(k) clearance in 2006 for Over-the-Counter use required to facilitate sales to US consumers; CE certification is not required to
market the product in the EU given that BreathScan® results are not used to diagnose any medical conditions. However, the Company
has received certification under the French Standard, NF X 20-702 which defines the specifications that chemical breath alcohol
detectors must meet in order to be sold to consumers in France. In addition, the Company’s breath alcohol detector technology was
granted an Australian Standard certification trademark, which cleared the commercial pathway for product sales in Australia, New
Zealand, and South Africa.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The Company’s disposable breath alcohol detectors are available in .02%, .04%, .05% and .08% blood alcohol concentrations
(“BACs”) and provide users with a test result in two minutes. If the crystals in the interior of the device change from yellow to aqua,
the user has tested positive for the specific alcohol level. Should the crystals remain yellow, the result is negative.
The Company’s proprietary breath alcohol detection technology is paired with the quantitative precision of an electronic analyzer in
the BreathScan® PRO alcohol detection system. As with all BreathScan® products, the test subject exhales into a specially calibrated,
BreathScan® PRO detector. The testing coordinator then inserts the used detector into the BreathScan® PRO Digital Analyzer. After
two minutes, the Analyzer’s sophisticated optics calculate the subject’s BAC; the detectable range spans from 0.00% to 1.50% BAC.
Unlike other electronic breathalyzers, BreathScan® PRO never requires recalibration so it is in “ready” mode at all times. In 2011, the
Company received FDA over-the-counter clearance for the system, providing a commercialization path in the U.S. for use by trained
professionals, including those in civil and military law enforcement, and the general public; in addition, the CE-Mark was affixed to
the alcohol detection system for professional use. Unlike the aforementioned BreathScan® disposable detectors, BreathScan® PRO is
required to have a CE-Mark as the system includes an electronic component, namely the digital analyzer.
8
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Since the appropriate regulatory clearances have been obtained in the United States and other major markets requiring specific
certifications for specific devices (i.e. France and Australia for the Company’s single-use detectors for these products), the Company
does not anticipate needing to fund additional clinical trials to facilitate or initiate product marketing in other international regions thus
far.
Other Emerging MPC Platform Products
The Company’s MPC Biosensor technology is being applied to the development of products that serve the nutraceutical and weight
loss marketplaces. As a category, these disposable screening tests are exempt from FDA 510(k) premarket clearances. Biomarkers
related to various metabolic processes can be measured in breath condensate. As a result, Akers has used its proprietary, easy-to-use
platform to design disposable breath tubes that measure ketone (acid) production associated with fat-burning (METRON® and
KetoChek) and oxidative stress levels that relate to cellular damage and the development of many preventable diseases (OxiChek).
The Company believes that personalized health and wellness - and eventually personalized medicine - will become an increasingly
significant market. The Company is positioning its tests for weight loss and oxidative stress for this market by designing a more
consumer-focused reagent device, and linking this device to an application for smartphones and tablets that can not only produce a
result, but also track progress over time. Initial marketing activities have commenced for these products and the Company is preparing
for commercialization. The Company is currently assessing distribution opportunities with companies specializing in weight loss
and/or mass distribution through health-related multilevel marketing organizations. Since devices with claims related to weight loss or
nutrition are exempt from FDA oversight, a clinical program to support 510(k) submission is not required for any of these products.
Given the non-medical intended use, the Company does not believe products will be required to hold a CE-mark prior to marketing in
the EU.
Akers is continuing its clinical development of the Breath Ketone “Check” disposable breath tube for the diagnosis of ketoacidosis in
diabetics. Breath Ketone “Check” is being designed to provide real-time information that allows diabetics to determine if they have a
more severe level of ketone (acid) build up in their body that can cause a life-threatening medical emergency called ketoacidosis. The
estimated 28.5 million Type I (insulin-dependent) diabetics worldwide are at particular risk for ketoacidosis and require routine
monitoring of their ketone levels. To date, the medical industry relies on blood and urine-based ketone testing methods, which are
invasive and/or inconvenient. Since breath and blood ketone levels are closely correlated, the Breath Ketone “Check” is designed to
offer healthcare professionals and their patients a convenient, accurate method, which can be completed anytime, anywhere, to quickly
determine if an individual’s ketone level is approaching a dangerous threshold requiring medical attention. Since this product requires
FDA 510(k) clearance, the Company continues to develop its technical file and complete required clinical studies to complete the
regulatory submission.
The Company is also devoting resources to the research and development of the Breath PulmoHealth “Check” suite of assays. These
disposable detectors are being designed to signal the detection of various biomarkers related to pulmonary health, namely asthma,
chronic obstructive pulmonary disease (“COPD”) and lung cancer, through convenient, rapid analysis of an individual’s breath
sample. Akers has chosen to target this trio of conditions due to their significant impact on global health:
●
●
●
over 300 million people worldwide are living with asthma and up to 18% of a country’s population are undiagnosed
asthmatics;
210 million individuals are being treated for COPD but each of the 1 billion smokers worldwide are at risk for the disease;
and
more than 1.6 million people worldwide receive the diagnosis of lung cancer annually with many more victims expected as
80% of all lung cancers can be attributed to smoking.
9
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Akers believes these statistics suggest that pulmonary conditions are under-diagnosed and under-treated and will continue to pose a
chronic strain on worldwide public health. Currently, diagnostic methods used for the detection of lung-related diseases and illnesses
are often costly as specialized medical personnel must facilitate analysis and testing, and radiologic exams or invasive surgical
procedures may be required. While Akers does not presume Breath PulmoHealth “Check” products to be replacements for such tests
in all markets, it does however have ambitions for the devices to become effective, highly cost-efficient, primary screening tools.
Their ease-of-use, portability and non-invasive nature provide healthcare professionals and public health officials with a testing
platform that can be deployed in high volume, and even in regions of the developing world. At present, the Company’s primary
development efforts are focused on configuring the clinical dossier for the asthma product.
The Breath Ketone “Check” and the Breath PulmoHealth “Check” suite of products will require the development of individual clinical
trial programs to facilitate eventual FDA 510(k) submissions. The Company has self-certified Breath Ketone “Check” as being in
compliance with CE requirements in the EU, and intends to pursue the same designation for each product in the Breath PulmoHealth
“Check” trio once the appropriate technical file is assembled.
MPC Biosensor technology is currently protected by one United States patents (8,871,521).
PIFA® Technology
The core products marketed under the PIFA® platform are the PIFA® Heparin/PF4 Rapid Assay, PIFA PLUSS® PF4, and a variety
of rapid Infectious Disease screening tests which target markets in the developing world.
PIFA® Heparin/PF4 Rapid Assay and PIFA PLUSS® PF4 remain the only FDA-cleared rapid manual assays that quickly determine
if a patient being treated with the blood thinner Heparin may be developing a drug allergy. This clinical syndrome, referred to as
Heparin-Induced Thrombocytopenia (“HIT”), reverses the Heparin’s intended therapeutic effect and transforms it into a clotting agent.
According to “ Current Concepts Review: Heparin-Induced Thrombocytopenia” , published by Foot and Ankle International in 2008
(the “HIT Report”), patients with HIT are at risk of developing limb- and life-threatening complications, so the timely test result
provided by Akers’ Heparin/PF4 devices is paramount to effective clinical decision making. In the U.S. alone, approximately 12
million patients are exposed to Heparin annually and 1% to 5% of those patients receive a HIT diagnosis. The largest at-risk
populations are patients undergoing major cardiac or orthopedic surgical procedures. It is estimated that up to 50% of cardiac surgery
patients develop HIT-antibodies. Given the size of the aging baby boomer market segment and the prevalence of cardiac disease,
surgeries within this category is expected to increase, as would the potential demand for the Company’s convenient, rapid tests.
The PIFA® Heparin/PF4 Rapid Assay improves the standard of care in HIT-testing with its result delivered in less than five minutes
after the patient sample has been prepared. Traditional methods required the use of expensive equipment, specialized laboratory
personnel and approximately four hours of technician time to complete the 20+ assay test procedure in-house, Clinicians were
subjected to a 24-to-72 hour turnaround time if the HIT-antibody determination was outsourced to a reference laboratory. Especially
in the latter scenario, the patient information obtained is retrospective in nature as the HIT-antibody result cannot be factored into
time-sensitive diagnostic and treatment decisions. The Company has also introduced PIFA PLUSS PF4 to U.S. hospitals to further
improve the rate at which healthcare professionals can obtain a HIT-antibody result.
This PIFA® line extension merges the ease-of-use of the PIFA testing platform with Akers’ recently patented Rapid Blood Cell
Separation Technology, marketed under the brand name seraSTAT®. The marriage of these two technologies condenses the sample
preparation and analysis procedures as the precise micro-volume of a seraSTAT® -prepared patient specimen is delivered directly into
the PIFA® cassette for immediate testing. This eliminates an additional one-hour of sample processing time and the need for
healthcare personnel to have access to a centrifuge to separate the liquid fraction of blood from the cellular fraction. As a result,
HIT-testing can be initiated and completed at or near the point-of-care, especially in emergency and critical care departments where
time-efficient diagnostic results can drastically improve patient outcomes.
10
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Since the appropriate regulatory clearances have been obtained in the United States for these products, the Company does not
anticipate needing to fund additional clinical trials to facilitate product marketing domestically. In addition, the current technical file
that has been assembled for seraSTAT® and PIFA PLUSS PF4® will also be used to support Akers’ CE-marking self-certification
process to initiate product sales in the EU; the PIFA Heparin/PF4 Rapid Assay is already CE-marked. The Company’s strategy in
foreign jurisdictions that may require additional clinical trials to support regulatory clearance, as is the case in China, is to partner with
a distributor that will fund the required clinical program in exchange for some degree of marketing exclusivity.
Other PIFA® Platform Assays in development
According to the Center for Disease Control and Prevention, “Emerging Infectious Diseases: a 10-Year Perspective from the National
Institute of Allergy and Infectious Diseases, volume 11, Number 4 - April 2005”, infectious diseases account for more than 15
million deaths annually. That equates to one in every two deaths in developing countries. Given that more than 80% of the world’s
population lives in the 100-plus developing countries, the need for infectious disease screening tests and effective treatment options
has global implications. The expansive geographies combined with underdeveloped, underfunded healthcare infrastructures make
rapid, single-use, portable devices that do not require special instrumentation, key to any infectious disease-containment solution.
Akers’ PIFA® technology provides a testing format that meets the aforementioned criteria. The Company can quickly apply the PIFA
PLUSS® methodology to its infectious disease testing products to further consolidate the test result turn-around time and eliminate the
need for any specialized sample preparation personnel or equipment which are usually not at the disposal of healthcare professionals
in remote locations. To date, the Company’s custom reagent work has focused on a variety of infectious diseases, markers of
cardiovascular disease, and blood typing tests including the following:
●
●
●
●
●
Chlamydia
Malaria
Dengue Fever
Troponin I
ABOD Battlefield Blood Transfusion Card
REA Technology
Akers’ Tri-Cholesterol “Check” test is initiated with an easy-to-obtain finger stick blood sample, and provides users with an estimate
of both their total and high density lipoprotein (“HDL”) cholesterol levels, and by a simple calculation, approximates their low density
lipoprotein (“LDL”) level. We believe that there is global demand for this category of disposable tests given healthcare trends that
identify cardiovascular disease, and related risk factors like high cholesterol, diabetes and high blood pressure. These complications
are particularly on the rise in developing nations that have gained access to the dietary habits of the west. In fact, studies reported by
Middle East Health Magazine recently conducted in various medical centers throughout Saudi Arabia and the United Arab Emirates
(“UAE”) categorized the cardiovascular health risk as being on the edge of a potentially serious epidemic. In addition, the research
revealed that half the subjects were undiagnosed prior to participating in the study that may be indicative of insufficient healthcare
resources. This regional case study has global application as cardiovascular disease is the leading cause of death worldwide and access
to healthcare remains a challenge to much of the aggregate population. This drives home the need for rapid, straightforward screening
tests that are easily accessible to individuals for routine monitoring.
Tri-Cholesterol “Check” has the appropriate U.S. FDA market clearances and is also CE-marked for sale in the European Union for
professional use. At present, the Company’s Tri-Cholesterol “Check” business strategy is to focus on distribution activities in
countries within the developing world. Once Akers completes an assessment of opportunities within the region, it intends to determine
if additional clinical data outside of the robust technical file assembled to support FDA-clearance and CE-certification will be required
for product marketing.
The REA Technology is currently protected by three United States patents (8,808,639; 8,003,061; 8,425,859).
11
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Sample Preparation Technology
Rapid Blood Cell Separation Technology
In addition to the Company’s testing platforms, Akers’ recently patented Rapid Blood Cell Separation (“Separator”) Technology,
marketed under the brand name seraSTAT®, further accelerates the rate at which a test result is obtained as the often-required sample
preparation step is abbreviated drastically. Conventional methods of blood cell separation are labor-intensive and time-consuming,
typically involving blood collection and laboratory personnel, as well as electrically-powered centrifuges and other specialized
equipment. The Separator device requires only a small-volume blood sample obtained from a time- and cost-efficient finger stick
procedure.
The required micro-volume specimen of serum or plasma is immediately extracted and introduced into a rapid assay device for
real-time analysis. The savings afforded by the Separator device can be measured in time and cost given its quick turn-around-time
and straightforward, easy-to-master procedure.
Since the appropriate regulatory clearances have been obtained in the United States for seraSTAT® as a stand-alone device, the
Company does not anticipate needing to fund additional clinical trials to expand product marketing domestically. Currently,
seraSTAT® is integrated into PIFA PLUSS PF4 devices, and will be utilized in the infectious disease products currently under
development. Akers may consider partnerships with other medical device companies, functioning as an Original Equipment
Manufacturer (“OEM”), as the benefits of the seraSTAT® Rapid Blood Cell Separation Technology can be integrated into other assay
platforms. Also, the current technical file that has been assembled for seraSTAT® will be used to support Akers’ CE-marking
self-certification process to initiate product sales in the EU. The Company’s strategy in foreign jurisdictions that may require
additional clinical trials to support regulatory clearance is to partner with a distributor that will fund the required clinical program in
exchange for some degree of marketing exclusivity.
The seraSTAT® Rapid Blood Cell Separation Technologies currently protected by two United States patents (7,896,167; 8,097,171)
and one international patent (JP 4,885,134).
Competition
Competitors of Akers include other companies developing and marketing rapid, point-of-care diagnostic devices and companies with
dedicated laboratory instruments and/or automated test systems. We face intense competition from companies with dominant market
positions within the in vitro diagnostic testing market such as Abbott, ACON Laboratories, Inc., Alere, Diagnostica Stago, SA.,
Immucor, Inc., OraSure Technologies, Inc., and Quidel Corporation.
The Company believes the primary criteria for determining competitiveness within the rapid point-of-care sector are cost, ease-of-use,
speed, readability, accuracy and flexibility. The time required by Akers to develop a working prototype test ready for clinical trials
typically ranges from eight to twelve weeks from inception. We believe that competitors’ laboratory tests normally require at least a
year to develop to a similar point.
However, our competitors have significantly greater financial, technical, marketing and other resources than we have and may be
better able to:
●
●
●
respond to new technologies or technical standards;
devote resources to the development, production, promotion, support and sale of products;
acquire other companies to gain new technologies or products that may displace our product lines;
12
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
●
●
●
react to changing customer requirements and expectations;
manufacture, market and sell products; and
deliver a broad range of competitive products at lower prices.
Our principal competitors are able to leverage their broader product portfolios and dominant market positions in some segments by,
for example, bundling their products into specially priced packages that create strong financial incentives for their customers to
purchase their products. These practices may negate savings customers would gain from buying select products from Akers and may
deter such customers from buying Akers’ products. We expect competition in the markets in which we participate to continue to
increase as existing competitors improve or expand their product offerings.
How we Generate Revenue
The majority of our revenue comes from selling rapid, screening and testing products, largely through our distribution networks. Some
of our assays are used in the clinical laboratory to ultimately help healthcare professionals to diagnose a medical condition or
complication that may require treatment. Other products can be sold over-the-counter, to the general public, to help assess an
individual’s status as it relates to his/her blood alcohol or cholesterol level, to help monitor his/her progress on a specific wellness
regimen, and/or to screen for a biomarker that may be indicative of an individual’s general level of health. Some of our revenue is
associated with licensing payments that may relate to exclusive access to specific markets.
Our Current Target Markets
Regarding the Company’s test for the heparin drug allergy, the testing market largely resides within the clinical hospital laboratories
of medical facilities. In the U.S., the Company accesses decision makers within these institutions through profiling by its highly
trained technical sales team and collaborative prospecting with distributor sales representatives. Internationally, Akers provides
comprehensive training to its distributor partners which will enable them to implement the same selling and technical training
strategies.
The markets for alcohol breathalyzers are reached through a network of large and small distributors. These markets include industrial
safety, education, law enforcement, social responsibility and retail.
The health and wellness markets include nutraceutical companies, fitness centers and diet and weight loss centers.
Manufacturing and Suppliers
We are a vertically integrated manufacturer, producing substantially all of our devices in-house. The vast majority of our products
start out as high quality, medical grade polymers and exit our facilities as fully manufactured and packaged medical devices. As a
result, we have a short supply line between our raw materials and finished goods which gives us greater control over our product
quality. The downside of our in-house manufacturing is the requirements for facilities, power, and equipment. This approach also
requires mid-to-long-term planning and the ability to predict future needs. Many of our processes are unique to us, but the Company’s
flexible manufacturing capabilities and unused current capacity generally translate into relatively short production timelines. As
demand for our products increase, additional capacities may be required to advance our evolving needs.
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. US medical device
manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements
and specifications. The quality systems for FDA-regulated products are known as current good manufacturing practices (“cGMP’s”).
cGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and
Cosmetic Act. We work closely with our suppliers to ensure continuity of supply while maintaining high quality and reliability. To
date, we have not experienced any significant difficulty locating and obtaining the materials necessary to fulfill our production
requirements.
13
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
On February 4, 2015, the Company’s quality management system was certified as compliant with the International Standards
Organization’s (“ISO”) 13485:2003 requirements for the design, manufacture and distribution of medical devices including in vitro
diagnostic products.
Distribution
We distribute our products through direct and indirect channels of distribution. We have well-developed indirect distribution channels
in the U.S. with, among others, Cardinal Health 200, Inc. (“Cardinal Health”), Fisher Healthcare, a Division of Fisher Scientific
Company L.L.C. (“Fisher Healthcare”), Medline Industries, Inc. (“Medline”), and Typenex Medical L.L.C. (“Typenex”) for the
Company’s PIFA Heparin/PF4 assays. The relationships with Cardinal Health and Fisher Healthcare provide us with access to the
majority of U.S. hospitals.
With respect to the Company’s breath alcohol franchise, historically Akers focused its commercial attention within the on-the-job
safety/human resources sector. Access was and currently is largely achieved through designated BreathScan® distributors and limited
arrangements in which the Company serves in an OEM capacity.
Our dedicated technical sales force works in tandem with distributor sales representatives to uncover opportunities in the clinical
laboratory marketplace. The Company facilitates direct sales for hospitals that prefer to purchase direct from the manufacturer.
Since 2012, the Company has also had a distribution relationship with Novotek Therapeutics Inc. (“Novotek”), a Beijing-based
pharmaceutical and in vitro diagnostic business development corporation. The multi-year distribution agreement assigns exclusive
sales and marketing rights to Novotek to make Akers’ Particle ImmunoFiltration Assay (“PIFA”) products available in Mainland
China and that market clearance has now been obtained.
In select European countries and Australia we have distribution relationships with specialized sales and marketing organizations for
some of our products. We do not have a strong presence in many emerging markets, but are seeking to enter into agreements to enable
us to enter other international markets in the current fiscal year.
During the year ended December 31, 2015 sales to Cardinal Health and Fisher Healthcare accounted for a significant part of the
Company’s product revenue. This concentration makes the Company vulnerable to a near-term severe impact should the relationships
be terminated.
Joint Venture
On October 24, 2014, the Company entered into a Joint Venture Agreement (the “Joint Venture Agreement”) by and among the
Company, Hainan Savy Investment Management Ltd. (“Hainan”) and Mr. Thomas Knox, the Company’s Non-Executive
Co-Chairman, to research, develop, produce and sell certain Akers rapid diagnostic screening and testing products in China (the “Joint
Venture”). The Joint Venture is located in Haikou, the capital city of Hainan, China, and is incorporated as Hainan Savy Akers
Biosciences, Ltd (“HSAB”).
Intellectual Property
We rely on a combination of patent, trademark and trade secret laws in the U.S. and other jurisdictions to protect our proprietary
platform technologies and our brands. We also rely on confidentiality procedures and agreements with key employees and
distribution/business partners where appropriate, and contractual provisions to achieve the same. We do not pursue patent protection
where the possibility for meaningful enforcement is limited.
14
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The Akers logo is a registered trademark in the U.S. Other registered trademarks/service marks include: BreathScan®, PIFA®, PIFA
PLUSS®, seraSTAT®, HealthTest®, and Be a Hero, Get Their Keys®, and METRON®.
The following table summarizes the U.S. and international utility patents that currently protect Akers intellectual property; the core
and emerging products to which they relate are also noted:
Description
Jurisdiction
Utility
Patent
No.
Type of
Protection
Expiration
Date
Product(s) To Which
They Relate
breath Ketone detector
US
8,871,521 Manufacture
3/8/2031
Breath Ketone “Check” ®
blood separator and
method of separating fluid
fraction from whole blood
blood separator and
method of separating fluid
fraction from whole blood
blood separator and
method of separating fluid
fraction from whole blood
US
7,896,167 Manufacture
9/7/2026
US
8,097,171 Manufacture
8/5/2025
Japan
4,885,134 Manufacture
8/5/2025
ligand assay method
US
5,827,749 Manufacture
methods and kits for
detecting heparin/platelet
factor 4 antibodies
Japan
4,931,821 Manufacture
10/4/2025
seraSTAT®; PIFA PLUSS®
PF4; PIFA PLUSS®
Infectious Diseases Rapid
Assays
seraSTAT®; rapid blood cell
separator also integrated into
PIFA PLUSS® PF4 and PIFA
PLUSS® Infectious Diseases
Rapid Assays
seraSTAT®; rapid blood cell
separator also integrated into
PIFA PLUSS® PF4 and PIFA
PLUSS® Infectious Diseases
Rapid Assays
PIFA® Heparin/PF4 Rapid
Assay; PIFA PLUSS® PF4;
PIFA PLUSS® Infectious
Diseases Rapid Assays
PIFA® Heparin/PF4 Rapid
Assay; PIFA PLUSS® PF4
test strip card
US
8,003,061 Manufacture
5/6/2024
Tri-Cholesterol “Check”®
test strip card
US
8,425,859 Manufacture
5/6/2024
Tri-Cholesterol “Check”®
test strip card
US
8,808,639 Manufacture
5/6/2024
Tri-Cholesterol “Check”®
15
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Circumstances outside our control could pose a threat to our intellectual property. For example, effective intellectual property
protection may not be available in every country in which our products are distributed. Also, the efforts we have taken to protect our
proprietary rights may not be sufficient or effective. Any significant impairment of our intellectual property rights is costly and time
consuming. Any increase in unauthorized use of our intellectual property could make it more expensive to do business and harm our
operating results.
Akers’ Tri-Cholesterol “Check”, PIFA Heparin/PF4 Rapid Assay, BreathScan PRO alcohol detection system, and the Breath Ketone
“Check” are CE-marked for sale in the EU for professional use. The CE-mark must be affixed to a product that is intended, by the
manufacturer, to be used for a medical purpose and will be sold into EU member states as well as Iceland, Norway and Liechtenstein.
For Akers’ current and proposed “medical-purpose” products, the CE-marking process is facilitated by self-certification, as a
manufacturer must carry out a conformity assessment, perform any appropriate electromagnetic testing, create a technical file with
supporting documentation, and sign an EC declaration of conformity. The documentation is verified by the Company’s authorized
representative in the EU and must be made available to authorities upon request.
Government Regulations
FDA Approval/Clearance Requirements
Unless an exemption applies, each medical device that we wish to market in the U.S. must receive 510(k) clearance. It has been the
Company’s experience thus far, that the FDA’s 510(k) clearance process usually takes from four to twelve months, but can last
significantly longer. We cannot be sure that 510(k) clearance will ever be obtained for any product we propose to market. We have
obtained the required FDA clearance for all of our current products that require such clearance.
The FDA decides whether a device line must undergo either the 510(k) clearance or Premarket approval (“PMA”). PMA is the FDA
process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are
those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a
potential, unreasonable risk of illness or injury. The PMA approval process is based on statutory criteria. These criteria include the
level of risk that the agency perceives is associated with the device and a determination whether the product is a type of device that is
similar to devices that are already legally marketed. Devices deemed to pose relatively less risk are placed in either Class I or II, which
requires the manufacturer to submit a premarket notification (“PMN”) requesting 510(k) clearance, unless an exemption applies. The
PMN must demonstrate that the proposed device is “substantially equivalent” in intended use and in safety and effectiveness to a
legally marketed predicate device, which is a pre-existing medical device to which equivalence can be drawn, that is either in Class I,
Class II, or is a Class III device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for
submission of a PMA application.
Class I devices are those for which safety and effectiveness can be assured by adherence to the FDA’s general regulatory controls for
medical devices, or the General Controls, which include compliance with the applicable portions of the FDA’s quality system
regulations, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading
labeling, advertising, and promotional materials. Some Class I devices also require premarket clearance by the FDA through the
510(k) PMN process described below. A small number of our products are Class I devices.
16
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Class II devices are subject to the FDA’s General Controls, and any other special controls as deemed necessary by the FDA to ensure
the safety and effectiveness of the device. Premarket review and clearance by the FDA for Class II devices is accomplished through
the 510(k) PMN procedure. Pursuant to the Medical Device User Fee and Modernization Act of 2002, or MDUFMA, as of October
2002 unless a specific exemption applies, 510(k) PMN submissions are subject to user fees. Certain Class II devices are exempt from
this premarket review process. A majority of our products, encompassing all of our significant product lines, are Class II devices.
Class III devices are those devices which have a new intended use, or use advanced technology that is not substantially equivalent to
that of a legally marketed device. The safety and effectiveness of Class III devices cannot be assured solely by the General Controls
and the other requirements described above. These devices almost always require formal clinical studies to demonstrate safety and
effectiveness and must be approved through the premarket approval process described below. Premarket approval applications (and
supplemental premarket approval applications) are subject to significantly higher user fees under MDUFMA than are 510(k) PMNs.
None of our products are Class III devices.
A clinical trial may be required in support of a 510(k) submission. These trials generally require an Investigational Device Exemption,
or IDE, application approved in advance by the FDA for a specified number of patients, unless the product is deemed a non-significant
risk device eligible for more abbreviated IDE requirements. The IDE application must be supported by appropriate data, such as
animal and laboratory testing results. Clinical trials may begin if the IDE application is approved by the FDA and the appropriate
institutional review boards at the clinical trial sites.
Pervasive and Continuing FDA Regulation
A host of regulatory requirements apply to our marketed devices, including the quality system regulation (which requires
manufacturers to follow elaborate design, testing, control, documentation and other quality assurance procedures), the Medical
Reporting Regulations (“MDR”) regulations (which require that manufacturers report to the FDA specified types of adverse events
involving their products), labeling regulations, and the FDA’s general prohibition against promoting products for unapproved or
“off-label” uses. Class II devices also can have special controls such as performance standards, post-market surveillance, patient
registries and FDA guidelines that do not apply to class I devices. Unanticipated changes in existing regulatory requirements or
adoption of new cGMP requirements could hurt our business, financial condition and results of operations.
Health Care Fraud and Abuse
In the United States, there are federal and state anti-kickback laws that generally prohibit the payment or receipt of kickbacks, bribes
or other remuneration in exchange for the referral of patients or other health-related business. For example, the Federal Health Care
Programs’ Anti-Kickback Law (42 U.S.C. §1320a-7b(b)) prohibits anyone from, among other things, knowingly and willfully
offering, paying, soliciting or receiving any bribe, kickback or other remuneration intended to induce the referral of patients for, or the
purchase, order or recommendation of, health care products and services reimbursed by a federal health care program (including
Medicare and Medicaid). Recognizing that the federal anti-kickback law is broad and potentially applicable to many commonplace
arrangements, the Office of Inspector General within the Department of Health and Human Services, or OIG, has issued regulations,
known as the safe harbors, which identify permissible practices. If all of the requirements of an applicable safe harbor are met, an
arrangement will not be prosecuted under this law. Safe harbors exist for a number of arrangements relevant to our business,
including, among other things, payments to bona fide employees, certain discount arrangements, and certain payment arrangements
involving GPOs. The failure of an arrangement to fit precisely within one or more safe harbors does not necessarily mean that it is
illegal. However, conduct that does not fully satisfy each requirement of an applicable safe harbor may result in increased scrutiny by
government enforcement authorities, such as the OIG or the Department of Justice. Violations of this federal law can result in
significant penalties, including imprisonment, monetary fines and assessments, and exclusion from Medicare, Medicaid and other
federal health care programs. Exclusion of a manufacturer would preclude any federal health care program from paying for its
products. In addition to the federal anti-kickback law, many states have their own kickback laws. Often, these state laws closely follow
the language of the federal law. Some state anti-kickback laws apply regardless of whether a federal health care program payment is
involved. Federal and state anti-kickback laws may affect our sales, marketing and promotional activities, and relationship with health
care providers or laboratory professionals by limiting the kinds of arrangements we may have with hospitals and others in a position to
purchase or recommend our products.
17
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Federal and state false claims laws prohibit anyone from presenting, or causing to be presented, claims for payment to third-party
payors that are false or fraudulent. For example, the federal Civil False Claims Act (31 U.S.C. §3729 et seq.) imposes liability on any
person or entity who, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a
federal health care program (including Medicaid and Medicare). Manufacturers, like us, can be held liable under false claims laws,
even if they do not submit claims to the government, where they are found to have caused submission of false claims by, among other
things, providing incorrect coding or billing advice about their products to customers that file claims, or by engaging in kickback
arrangements with customers that file claims. A number of states also have false claims laws, and some of these laws may apply to
claims for items or services reimbursed under Medicaid and/or commercial insurance. Sanctions under these federal and state laws
may include civil monetary penalties, exclusion of a manufacturer’s products from reimbursement under government programs, and
imprisonment.
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, created two new federal crimes: health care fraud and
false statements related to healthcare matters. The health care fraud statute prohibits knowingly and willingly executing a scheme to
defraud any health care benefit program, including private payors. A violation of this statute is a felony and may result in fines,
imprisonment or exclusion from government sponsored programs. The false statements statute prohibits knowingly and willfully
falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection
with the delivery of or payment for health care benefits, items or services. A violation of this statute is a felony and may result in fines
or imprisonment.
Due to the breadth of some of these laws, it is possible that some of our current or future practices might be challenged under one or
more of these laws. In addition, there can be no assurance that we would not be required to alter one or more of our practices to be in
compliance with these laws. Evolving interpretations of current laws or the adoption of new federal or state laws or regulations could
adversely affect many of the arrangements we have with customers and physicians. Our risk of being found in violation of these laws
is increased by the fact that some of these laws are open to a variety of interpretations. If our past or present operations are found to be
in violation of any of these laws, we could be subject to civil and criminal penalties, which could hurt our business, results of
operations and financial condition.
Foreign Regulation
Many foreign countries in which we market or may market our products have regulatory bodies and restrictions similar to those of the
FDA. International sales are subject to foreign government regulation, the requirements of which vary substantially from country to
country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval and
the requirements may differ. Companies are now required to obtain a CE Mark, which shows conformance with the requirements of
applicable European Conformity directives, prior to sale of some medical devices within the European Union. Some of our current
products that require CE Markings have them and it is anticipated that additional and future products may require them as well. As of
the date of this filing, the Company has received CE marks for eight for of its commercialized products/product components: PIFA
Heparin/PF4 Rapid Assay; Heparin/PF4 Serum Panels; Tri-Cholesterol “Check” and BreathScan PRO Detectors, Analyzer Field Kit,
Starter Kit and Blow Bags.
18
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Third-Party Reimbursement
Health care providers, including hospitals, that purchase our products generally rely on third-party payors, including the Medicare and
Medicaid programs, and private payors, such as indemnity insurers and managed care plans, to cover and reimburse all or part of the
cost of the products and the procedures in which they are used. As a result, demand for our products is dependent in part on the
coverage and reimbursement policies of these payors.
CMS, the federal agency responsible for administering the Medicare program, along with its contractors establishes coverage and
reimbursement policies for the Medicare program. In addition, private payors often follow the coverage and reimbursement policies of
Medicare. We cannot assure you that government or private third-party payors will cover and reimburse the procedures using our
products in whole or in part in the future or that payment rates will be adequate.
In general, Medicare will cover a medical product or procedure when the product or procedure is reasonable and necessary for the
diagnosis or treatment of an illness or injury. Even if the medical product or procedure is considered medically necessary and
coverage is available, Medicare may place restrictions on the circumstances where it provides coverage. For some of our products, our
success in non-U.S. markets may depend upon the availability of coverage and reimbursement from the third-party payors through
which health care providers are paid in those markets. Health care payment systems in non-U.S. markets vary significantly by country,
and include single-payor, government managed systems as well as systems in which private payors and government-managed systems
exist, side-by-side. For some of our products, our ability to achieve market acceptance or significant sales volume in international
markets may be dependent on the availability of reimbursement for our products under health care payment systems in such markets.
There can be no assurance that reimbursement for our products, will be obtained or that such reimbursement will be adequate.
Other U.S. Regulation
We must also comply with numerous federal, state and local laws relating to matters such as environmental protection, safe working
conditions, manufacturing practices, fire hazard control and, among other things, the generation, handling, transportation and disposal
of hazardous substances.
Employees
We currently employ 36 full-time equivalent employees, contractors or consultants, which include 9 in research and development, 6 in
general and administrative, 10 in sales and marketing and 11 in direct and indirect manufacturing. We also engage a number of
temporary employees and consultants. None of our employees are represented by a labor union or are a party to a collective bargaining
agreement. We believe that we have good relations with our employees.
Available information
Our website address is www.akersbio.com. We do not intend our website address to be an active link or to otherwise incorporate by
reference the contents of the website into this Report. The public may read and copy any materials the Company files with the U.S.
Securities and Exchange Commission (the “SEC”) at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549.
The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0030. The SEC
maintains an Internet website (http://www.sec.gov) that contains reports, proxy and information statements and other information
regarding issuers that file electronically with the SEC.
Item 1A. Risk Factors.
You should carefully consider the risks described below, together with all of the other information included in this report, in
considering our business and prospects. The risks and uncertainties described below are not the only ones facing the Company.
Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business
operations. The occurrence of any of the following risks could harm our business, financial condition or results of operations.
19
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Risks Related to the Company and Our Business
We have a history of operating losses and we cannot guarantee that we can ever achieve sustained profitability.
We have recorded a net loss attributable to common stockholders in most reporting periods since our inception. Our net loss for the
years ended December 31, 2015 and December 31, 2014 were $9,311,913 and $3,142,960, respectively. Our accumulated deficit at
December 31, 2015 was $94,175,999. Losses are expected to continue for the foreseeable future. The Company expects to continue to
have development costs as it develops its next generation of products. We may never achieve profitable operations or positive cash
flow.
Our operating expenses will increase as we make further expenditures to enhance and expand our operations in order to support
additional growth in our business and public company reporting and compliance obligations.
Historically, we limited our investment in infrastructure; however, we expect our infrastructure investments to increase substantially to
support our anticipated growth and as a result of our becoming a public reporting company in the United States. We intend to make
additional investments in automated manufacturing systems and personnel in order to expand our operations to support anticipated
growth in our business. In addition, to be competitive and take advantage of market opportunities, we may need to make changes to
our sales model in the future. These changes may result in higher selling, general and administrative expenses as a percentage of our
revenue. We also expect to incur ongoing operating costs of being a public reporting company. As a result of these factors, we expect
our operating expenses to increase.
Due to our dependence on a limited number of customers and the loss of any such customer would have a material adverse effect
on our operating results and prospects.
As of December 31, 2015, we had two principal customers; Cardinal Health 200, Inc. (“Cardinal Health”) and Fisher Healthcare
(“Fisher”) each has the non-exclusive right to distribute PIFA Heparin/PF4 Rapid Assays within the U.S..
For the year ended December 31, 2015, Cardinal Health and Fisher accounted for approximately 65% of the Company’s product
revenue.
Because of our dependence on a limited number of key customers, the loss of a major customer (or loss of a key program with a major
customer), or any significant reduction in orders by a major customer or termination of the any of their distribution agreements would
materially affect our business, our results of operations and our financial condition. We expect that sales to relatively few customers
will continue to account for a significant percentage of our net sales for the foreseeable future, however there can be no assurance that
any of these customers or any of our other customers will continue to utilize our products or our services at current levels.
Due to our dependence on a limited number of customers, we are subject to a concentration of credit risk.
As of December 31, 2015, two customers accounted for 28% of our trade receivables. In the case of insolvency by one of our
significant customers, a trade receivable with respect to that customer might not be collectible, might not be fully collectible, or might
be collectible over longer than normal terms, each of which could adversely affect our financial position.
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. To date, we have not
experienced any significant difficulty locating and obtaining the materials necessary to fulfill our production requirements. Three
suppliers accounted for 41% of the Company’s total purchases during the year ended December 31, 2015. 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.
20
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
We may require additional capital in the future to develop new products and otherwise support our operations. If we do not obtain
any such additional financing, if required, our business prospects, financial condition and results of operations will be adversely
affected.
We intend to invest significantly in our business; therefore, we expect cash flows from operations to be inadequate to cover our
anticipated expenses. We believe we have sufficient capital to satisfy our needs for at least the next twelve months. We may need to
obtain significant additional financing, both in the short and long-term, to make planned capital expenditures, to cover operating
expenses, upgrades to our manufacturing operations, our ongoing product development and to fund to potential acquisitions, if any.
We may not be able to secure adequate additional financing when needed on acceptable terms, or at all. To execute our business
strategy, we may issue additional equity securities in public or private offerings. If we cannot secure sufficient additional funding we
may be forced to forego strategic opportunities and/or delay, scale back or eliminate future product development which would harm
our business and our ability to generate positive cash flow in the future.
Because we may not be able to obtain necessary regulatory clearances or approvals for some of our products, we may not generate
revenue in the amounts we expect, or in the amounts necessary to continue our business.
All of our proposed and existing products are subject to regulation in the U.S. by the U.S. Food and Drug Administration and/or other
domestic and international governmental, public health agencies, regulatory bodies or non-governmental organizations. In particular,
we are subject to strict governmental controls on the development, manufacture, labeling, distribution and marketing of our products.
The process of obtaining required approvals or clearances varies according to the nature of and uses for, a specific product. These
processes can involve lengthy and detailed laboratory testing, human clinical trials, sampling activities, and other costly,
time-consuming procedures. The submission of an application to a regulatory authority does not guarantee that the authority will grant
an approval or clearance for product. Each authority may impose its own requirements and can delay or refuse to grant approval or
clearance, even though a product has been approved in another country.
The time taken to obtain approval or clearance varies depending on the nature of the application and may result in the passage of a
significant period of time from the date of submission of the application. Delays in the approval or clearance processes increase the
risk that we will not succeed in introducing or selling the subject products, and we may be required to abandon a proposed product
after devoting substantial time and resources to its development.
Changes in domestic and foreign government regulations could increase our costs and could require us to undergo additional trials or
procedures, or could make it impractical or impossible for us to market our products for certain uses, in certain markets, or at all.
Changes in government regulations may adversely affect our financial condition and results of operations because we may have to
incur additional expenses if we are required to change or implement new testing, manufacturing and control procedures. If we are
required to devote resources to develop such new procedures, we may not have sufficient resources to devote to research and
development, marketing, or other activities that are critical to our business.
We are subject to regulations of various government agencies and if we are unable to comply with such regulations it would
materially affect our business .
We can manufacture and sell our products only if we comply with certain regulations of government agencies. As a U.S.
manufacturer, we must operate our production facility in accordance with the requirements established by the FDA under the Federal
Food, Drug, and Cosmetic Act (FD&C Act). As such, we have implemented a quality system that is intended to comply with
applicable regulations. Our manufacturing plant is subject to periodic inspections by the FDA, and at last inspection, the facility was
found to be in substantial compliance with current good manufacturing practice (cGMP) requirements. Although the Company is
dedicated to remaining in compliance with such practices, the cGMP requirements could change and negatively impact our ability to
manufacture our products without modifications to our operating procedures or changes to our equipment or human resource
allocations which may materially affect our business.
21
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The commercial success of our products will depend upon the degree of market acceptance by physicians, hospitals, third-party
payors, and others in the medical community.
Ultimately, none of our current products or products in development, even if they receive approval, may ever gain market acceptance
by physicians, hospitals, third-party payors or others in the medical community. If these products do not achieve an adequate level of
acceptance, we may not generate significant product revenue and we may not become profitable. The degree of market acceptance of
our products, if approved for commercial sale, will depend on a number of factors, including:
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the efficacy and potential advantages over alternative treatments;
the ability to offer our products for sale at competitive prices;
the willingness of the target population to accept and adopt our products;
the strength of marketing and distribution support and the timing of market introduction of competitive products; and
publicity concerning our products or competing products and treatments.
Even if a potential product displays a favorable profile, market acceptance of the product will not be known until after it is launched.
Our efforts to educate the medical community and third-party payors on the benefits of our products may require significant resources
and may never be successful. Such efforts to educate the marketplace may require more resources than are required by conventional
technologies marketed by our competitors.
If we fail to obtain regulatory approval in foreign jurisdictions, then we cannot market our products in those jurisdictions.
We plan to market some of our products in foreign jurisdictions, initially in China, the European Union (“EU”) and South America,
initially targeting Colombia and Brazil. Many foreign countries in which we market or may market our products have regulatory
bodies and restrictions similar to those of the FDA. International sales are subject to foreign government regulation, the requirements
of which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or
shorter than that required for FDA approval and the requirements may differ. Companies are now required to obtain a CE Mark, which
shows conformance with the requirements of applicable European Conformity directives, prior to the sale of some medical devices
within the European Union. Some of our current products that require CE Markings have them and it is anticipated that additional and
future products may require them as well. We may be required to conduct additional testing or to provide additional information,
resulting in additional expenses, to obtain necessary approvals. If we fail to obtain approval in such foreign jurisdictions, we would
not be able to sell our products in such jurisdictions, thereby reducing the potential revenue from the sale of our products.
We may be unable to market our products outside the United States if our products cannot meet certain requirements of the
Federal Food, Drug and Cosmetic Act requirements for exporting medical devices.
Any medical device that is legally marketed in the U. S. may be exported anywhere in the world without prior FDA notification or
approval. Medical devices that are not FDA-cleared for marketing legally in the U.S. may be exported under section 801(e)(1) of the
FD&C Act, provided that they are intended for export only, they are class I or class II devices, and they are:
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In accordance with the specifications of the foreign purchaser;
Not in conflict with the laws of the country to which they are intended for export;
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The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
●
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Labeled on the outside of the shipping package that they are intended for export; and
Not sold or distributed in the U.S.
We cannot guarantee that certain current and future products will meet all of the aforementioned specifications for export which could
adversely impact our ability to market our products outside the U.S.
We may be unable to market our products outside the United States if our products cannot meet regulatory requirements of certain
countries.
In the European Union, a product that meets the definition of an In Vitro Diagnostic Medical Device (“IVD”) in accordance with the
European Directive (98/79/EC) must receive a regulatory approval known as a CE mark. The letters “CE” are the abbreviation of the
French phrase “Conforme Européene,” which means “European conformity.” As such, export of these products to the European
Union, and possibly other jurisdictions, without the CE mark is not possible. Although obtaining a CE Mark is often a
self-certification process, preparation and submission of the technical file to an Authorized Representative in the EU, and their
verification of a company’s compliance with the Directive, can be a lengthy process. Some of the Company’s current and future
products may fall within the IVD categorization. As of the date of this filing, the Company has received CE marks for eight of its
commercialized products and product components: PIFA Heparin/PF4 Rapid Assay; Heparin/PF4 Serum Panels; Tri-Cholesterol
“Check” and BreathScan PRO Detectors, Analyzer Field Kit, Starter Kit and Blow Bags. An earlier version of the Breath Ketone
“Check” also bears a CE-Mark.
Further, some foreign countries, such as Canada and India, require that a medical device company’s manufacturing facility be certified
for compliance with the ISO 13485, an international standard for quality systems management. The International Organization for
Standardization (“ISO”) is the world’s largest developer of standards with 148 member countries. The Company’s quality
management system received a certification of compliance with the ISO 13485:2003 requirements on February 4, 2015. The failure by
the Company to maintain this certification may limit Akers’ ability to obtain foreign regulatory approval on a timely basis, if at all and
to do so may cause Akers to incur additional costs or prevent Akers from marketing its products in foreign countries, which may have
a material adverse effect on its business and results of operations.
Our products may not be able to compete with new diagnostic products or existing products developed by well-established
competitors, which would negatively affect our business.
According to “In Vitro Diagnostic Tests Come out of the Lab and Into the Home”, an article published by MDDI online in March
2013, the diagnostic industry is focused on the testing of biological specimens in a laboratory or at the point-of-care and is highly
competitive and rapidly changing. Several companies produce diagnostic tests that compete directly with our testing product line,
including but not limited to, Abbott, ACON Laboratories, Inc., Alere, Diagnostica Stago, SA, Immucor, Inc., OraSure Technologies,
Inc., and Quidel Corporation. Many of these competitors have substantially greater financial, technical, marketing and other resources
than we do and enjoy other competitive advantages, including, greater name recognition; established relationships with health care
professionals, companies and consumers; additional lines of products and the ability to offer rebates or higher discounts and
incentives. As new products enter the market, our products may become obsolete or a competitor’s products may be more effective or
more effectively marketed and sold than ours. Although we have no specific knowledge of any competitor’s product that will render
our products obsolete, if we fail to maintain and enhance our competitive position or fail to introduce new products and product
features, our customers may decide to use products developed by our competitors, which could result in a loss of revenue and cash
flow.
In addition, the point-of-care diagnostics industry is undergoing rapid technological changes, with frequent introductions of new
technology-driven products and services, some of which focus on automated systems to provide rapid results. As new technologies
become introduced into the point-of-care diagnostic testing market, we may be required to commit considerable additional efforts,
time and resources to enhance our current product portfolio or develop new products. We may not have the available time and
resources to accomplish this and many of our competitors have substantially greater financial and other resources to invest in
technological improvements. We may not be able to effectively implement new technology-driven products and services or be
successful in marketing these products and services to our customers, especially if rapid, manual testing products become secondary,
in large markets, to automated point-of-care systems. If these potential developments come to fruition our operating results could be
materially harmed.
23
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Clinical trials that may be required to support regulatory submissions in the United States and in international markets are
expensive. We cannot assure that we will be able to complete any required clinical trial programs successfully within any specific
time period, and if such clinical trials take longer to complete than we project, our ability to execute our current business strategy
will be adversely affected.
Conducting clinical trials is a lengthy, time-consuming and expensive process. Before obtaining regulatory approvals for the
commercial sale of any products, we must demonstrate through clinical trials the safety and effectiveness of our products. We have
incurred, and we will continue to incur, substantial expense for, and devote a significant amount of time to, product development, pilot
trial testing, clinical trials and regulated, compliant manufacturing processes. During the year ended December 31, 2015 research and
development expense totaled $1,406,895. The estimated research and development expense for the year ending December 31, 2016 is
$1,200,000.
Even if completed, we do not know if these trials will produce statistically significant or clinically meaningful results sufficient to
support an application for marketing approval. Whether or not and how quickly we complete clinical trials is dependent in part upon
the rate at which we are able to advance the rate of patient enrollment, and the rate to collect, clean, lock and analyze the clinical trial
database.
Patient enrollment in trials is a function of many factors. These include the design of the protocol; the size of the patient population;
the proximity of patients to and availability of clinical sites; the eligibility criteria for the study; the perceived risks and benefits of the
product candidate under study; the medical investigators’ efforts to facilitate timely enrollment in clinical trials; the patient referral
practices of local physicians; the existence of competitive clinical trials; and whether other investigational, existing or new products
are available or approved for the indication. If we experience delays in patient enrollment and/or completion of our clinical trial
programs, we may incur additional costs and delays in our development programs, and may not be able to complete our clinical trials
on a cost-effective or timely basis. Accordingly, we may not be able to complete the clinical trials within an acceptable time frame, if
at all. If we fail to enroll and maintain the number of patients for which the clinical trial was designed, the statistical power of that
clinical trial may be reduced, which would make it harder to demonstrate that the product candidate being tested in such clinical trial
is safe and effective. Further, if we or any third party have difficulty enrolling a sufficient number of patients in a timely or
cost-effective manner to conduct clinical trials as planned, or if enrolled patients do not complete the trial as planned, we or a third
party may need to delay or terminate ongoing clinical trials, which could negatively affect our business.
The results of our clinical trials may not support either further clinical development or the commercialization of our product
candidates.
Even if our clinical trials are completed as planned, their results may not support either the further clinical development or the
commercialization of our product candidates. The FDA or government authorities may not agree with our conclusions regarding the
results of our clinical trials. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be
successful, and the results from any later clinical trials may not replicate the results of prior clinical trials and pre-clinical testing. The
clinical trial process may fail to demonstrate that our product candidates are safe and effective for indicated uses. This failure would
cause us to abandon a product candidate and may delay development of other product candidates. Any delay in, or termination of, our
clinical trials will delay the filing of our 510(k)’s and, ultimately, our ability to commercialize our product candidates and generate
product revenue. Each medical device marketed in the U.S. must receive a 510(k) clearance from the FDA. A 510(k) is a premarket
submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent
(“SE”), to a legally marketed device. Companies must compare their device to one or more similar legally marketed devices,
commonly known as “predicates”, and make and support their substantial equivalency claims. The submitting company may not
proceed with product marketing until it receives an order from the FDA declaring a device substantially equivalent. The substantially
equivalent determination is usually made within 90 days, based on the information submitted by the applicant.
24
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
In addition, we or the FDA may suspend our clinical trials at any time if it appears that we are exposing participants to unacceptable
health risks or if the FDA finds deficiencies in the conduct of these trials. A number of companies in the biotechnology industry have
suffered significant setbacks in advanced clinical trials despite promising results in earlier trials. In the end, we may be unable to
develop marketable products.
Modifications to our devices may require additional FDA approval which could force us to cease marketing and/or recall the
modified device until we obtain new approvals.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would
constitute a major change in its intended use, requires a new 510(k) clearance or could require a Premarket approval (“PMA”). PMA
is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III
devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which
present a potential, unreasonable risk of illness or injury. Currently the Company does not market devices within this Class III
category nor does it intend to in the foreseeable future. However, the FDA requires each manufacturer to make this determination in
the first instance, but the FDA can review any decision. If the FDA disagrees with a manufacturer’s decision not to seek a new 510(k)
clearance, the agency may retroactively require the manufacturer to seek 510(k) clearance or PMA approval. The FDA also can
require the manufacturer to cease marketing and/or recall the modified devices until 510(k) clearance or PMA approval is obtained.
We have modified one of our prescription use, 510(k)-cleared devices, specifically the PIFA Heparin/PF4 Rapid Assay to include our
seraSTAT Separator. However, we determined that, in our view, based on FDA guidance as to when to submit a 510(k) notification
for changes to a cleared device, new 510(k) clearances or PMA approvals are not required. We cannot assure you that the FDA would
agree with any of our decisions not to seek 510(k) clearance or PMA approval. If the FDA requires us to seek 510(k) clearance or
PMA approval for any modification, we also may be required to cease marketing and/or recall the modified device until we obtain a
new 510(k) clearance or PMA approval.
We are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements. If the
FDA finds that we have failed to comply, the agency can institute a wide variety of enforcement actions which may materially
affect our business operations.
We are subject to inspection and market surveillance by the FDA to determine compliance with regulatory requirements. If the FDA
finds that we have failed to comply, the agency can institute a wide variety of enforcement actions, ranging from a public warning
letter to more severe sanctions such as:
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fines, injunctions and civil penalties;
recall, detention or seizure of our products;
the issuance of public notices or warnings;
operating restrictions, partial suspension or total shutdown of production;
refusing our requests for 510(k) clearance of new products;
withdrawing 510(k) clearance already granted; and
criminal prosecution.
The FDA also has the authority to request repair, replacement or refund of the cost of any medical device manufactured or distributed
by us. Our failure to comply with applicable requirements could lead to an enforcement action that may have an adverse effect on our
financial condition and results of operations.
25
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
We may not have sufficient resources to effectively introduce and market our products, which could materially harm our operating
results.
Achieving market acceptance for our existing products such as our direct-to-consumer offerings (disposable breathalyzers) and
clinical laboratory testing solutions (Particle Immuno Filtration Assay (“PIFA”) based heparin-induced thrombocytopenia and
infectious disease rapid tests) and introducing new products (breath condensate detectors for the health & wellness categories) require
substantial marketing efforts and will require our sales account executives, contract partners, outside sales agents and distributors to
make significant expenditures of time and money. In some instances we will be significantly or totally reliant on the marketing efforts
and expenditures of our contract partners, outside sales agents and distributors. The Company has aligned its sales resources with the
regional sales segmentation of our clinical products distributors. Although this has positively impacted sales, the large account
executive territories may prove to be inefficient as we commercialize products and may hinder our revenue growth.
Because we currently have very limited marketing resources and sales capabilities, commercialization of our products, some of which
require regulatory clearance prior to market entrance, we must either expand our own marketing and sales capabilities or consider
collaborating with additional third parties to perform these functions. We may, in some instances, rely significantly on sales,
marketing and distribution arrangements with collaborative partners and other third parties. In these instances, our future revenue will
be materially dependent upon the success of the efforts of these third parties.
Should we determine that expanding our own marketing and sales capabilities is required, we may not be able to attract and retain
qualified personnel to serve in our sales and marketing organization, to develop an effective distribution network or to otherwise
effectively support our commercialization activities. The cost of establishing and maintaining a more comprehensive sales and
marketing organization may exceed its cost effectiveness. If we fail to further develop our sales and marketing capabilities, if sales
efforts are not effective or if costs of increasing sales and marketing capabilities exceed their cost effectiveness, our business, results
of operations and financial condition would be materially adversely affected.
We may not have the resources to conduct clinical protocols sufficient to yield data suitable for publication in peer-reviewed
journals and our inability to do so in the future could have an adverse effect on marketing our products effectively.
In order for our products targeted for use by hospital laboratory professionals and healthcare providers to be widely adopted, clinical
protocols that are designed to yield data suitable for publication in peer-reviewed journals should be carried out. These studies are
often time-consuming, labor-intensive and expensive to execute. The Company has not had the resources to effectively implement
such clinical programs within its clinical development activities and may not be able to do so in the future. In addition, if a protocol is
initiated, the results of which may ultimately not support the anticipated positioning and benefit proposition for the product. Either of
these scenarios could hinder our ability to market our products and revenue may decline.
Our future performance will depend largely on the success of products we have not developed yet.
Technology is an important component of our business and growth strategy, and our success depends to a significant extent on the
development, implementation and acceptance of new products. Commitments to develop new products must be made well in advance
of any resulting sales, and technologies and standards may change during development, potentially rendering our products outdated or
uncompetitive before their introduction. Our ability to develop products to meet evolving industry requirements and at prices
acceptable to our customers will be dependent on a number of factors including, funding availability to complete development efforts,
our ability to test and refine products, successfully conduct clinical trials and seek to obtain required FDA clearance or foreign
approval/certification for products that require such regulatory authorizations. Physician patients and third party payors and the
medical community may be slow to adopt any of our products. Moreover, there can be no assurance that the products that we are
developing will receive FDA clearance, work effectively in the marketplace or gain market acceptance. We may expend considerable
funds and other resources on the development of next-generation products without any guarantee that these products will be
successful.
If we are not successful in bringing new products to market, whether because we fail to address marketplace demand, fail to develop
viable technologies or otherwise, our revenue may decline and our results of operations could be seriously harmed.
26
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
If we fail to establish, maintain and expand relationships with distributors, sales of our products would decline.
The Company does not control the efforts of its distributors and its distributors are not prohibited from selling competing products.
Our ability to sell our products depends largely on the Company’s relationships with such distributors. Accordingly, we are subject to
the risk that they may not commit the financial and other resources to market and sell our products to our level of expectation, they
may experience financial hardship or they may otherwise terminate our relationship on short notice. In the U.S. clinical laboratory
marketplace, many of our existing and potential customers purchase our products through our two national distributors, Cardinal
Health and Fisher Health. Our sales account executives work in tandem with the distributor’s sales representatives to gain access to
decision makers within the majority of U.S. medical facilities. In addition, the Company relies on its distribution network to negotiate
pricing arrangements and contracts with Group Purchasing Organizations and their affiliated hospitals and other members. For the
years ended December 31, 2015 and 2014, 90% and 48%, respectively of total revenue from the sale of the Company’s Heparin/PF4
Assay products was generated through our U.S. distributors’ purchases, with Cardinal Health accounting for 57% and 36% of such
sales for each year ended December 31, 2015 and 2014. In the future, if we are unable to maintain existing relationships and/or grow
to be recognized as a prominent medical device supplier within these organizations, and/or develop new relationships with additional
U.S. and international distributors, our competitive position would likely suffer and our business would be harmed.
We have just begun to develop formal business relationships with foreign distributors for all of our in-line products. We will therefore
be dependent upon the financial health of these organizations to further grow our business internationally. If a distributor were to go
out of business, it would take substantial time, cost and resources to find a suitable replacement and the product registrations and
certifications held by such distributor may not be returned to us or to a subsequent distributor in a timely manner or at all. Any failure
to produce foreign sales may negatively affect our profitability in the short and long-term. Since some of our products have CE-Marks
and/or are earmarked for sale in Europe where healthcare regulation and reimbursement for medical devices vary significantly from
country to country, this changing environment could adversely affect our ability to sell our products in some European countries. In
addition, the Company is working with its joint venture partner in mainland China to register several of its products for eventual sale.
Since additional clinical studies must be performed by our joint venture partner within Chinese healthcare facilities as part of their
regulatory submission, there is no guarantee that the results of their protocol will support the successful registration of the products
and permit sales activity. Failure to gain product registration in China will hinder the Company’s ability to increase its revenue.
Our business is vulnerable to the availability of raw materials, our ability to forecast customer demand and our ability to manage
production capacity.
Our ability to meet customer demand depends, in part, on our production capacity and on obtaining supplies, a number of which can
only be obtained from a single supplier or a limited number of suppliers. A reduction or disruption in our production capacity or our
supplies could delay products and fulfillment of orders and otherwise negatively impact our business.
We must accurately predict both the demand for our products and the lead times required to obtain the necessary components and
materials. If we overestimate demand, we may experience underutilized capacity and excess inventory levels. If we underestimate
demand, we may miss delivery deadlines and sales opportunities and incur additional costs for labor overtime, equipment overuse and
logistical complexities. Additionally, our production capacity could be affected by manufacturing problems. Difficulties in the
production process could reduce yields or interrupt production, and, as a result, we may not be able to deliver products on time or in a
cost-effective, competitive manner. Our failure to adequately manage our capacity could have a material adverse effect on our
business, financial condition and results of operations.
Our ability to meet customer demand also depends on our ability to obtain timely and adequate delivery of materials, parts and
components from our suppliers. We generally do not maintain contracts with any of our key suppliers. From time to time, suppliers
may extend lead times, limit the amounts supplied to us or increase prices due to capacity constraints or other factors. Supply
disruptions may also occur due to shortages in critical materials. In addition, a number of our raw materials are obtained from a single
supplier. Many of our suppliers must undertake a time-consuming qualification process before we can incorporate their raw materials
into our production process. If we are unable to obtain materials from a qualified supplier, it can take up to a year to qualify a new
supplier, assuming an alternative source of supply is available. A reduction or interruption in supplies or a significant increase in the
price of one or more supplies could have a material adverse effect on our business, financial condition and results of operations.
27
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Our manufacturing facility is vulnerable to natural disasters and other unexpected losses, and we may not have adequate
insurance to cover such losses.
We have one manufacturing facility, located in Thorofare, New Jersey, for production of all of our finished goods production. Our
facility is susceptible to damage from fire, floods, loss of power or water supply, telecommunications failures and similar events.
Since some of our raw materials and finished goods are temperature-sensitive and our facility currently does not have a back-up
generator, a moderate-to-severe disruption in power may render various levels of our inventories unusable or unsalable, resulting in a
sufficient write off of inventory and may immediately impact our ability to generate revenue.
Any natural disaster could significantly disrupt our operations. In the event that our facility was affected by a natural or man-made
disaster, we would be forced to rely on third-party manufacturers. Our insurance for damage to our property and the disruption of our
business from casualties may not be sufficient to cover all of our potential losses and may not continue to be available to us on
acceptable terms, or at all. If we are forced to seek alternative facilities, we may incur additional transition costs and we may
experience a disruption in the supply of our products until the new facility is available and operating. In addition, much of the
machinery we use in our production process is custom-made. If such machinery is damaged, we may experience a long lead-time
before this unique machinery is replaced or rebuilt and we are able to resume production.
Our manufacturing and distribution operations are highly dependent on our information technology systems and we do not currently
have a redundant data center. In the event of a failure of our primary data center, our manufacturing and distribution operations will be
disrupted which will adversely affect our business.
In addition, any disruption, delay, transition or expansion of our manufacturing operations could impair our ability to meet the demand
of our customers and our customers may cancel orders or purchase products from our competitors, which could adversely affect our
business, financial condition and results of operations.
Some of our finished goods, including our PIFA products and control materials related to PIFA Heparin/PF4 assays, are
temperature-sensitive.
Proper packaging and time in transit are critical to the stability of some of our clinical laboratory products when they are en route to
our distributors or end users. If certain specialized packaging materials cannot be obtained, and/or if our contracted common carriers,
or those of our distributors, cannot meet product-specific delivery requirements, our products may not perform as intended and may
lead to requests for product replacement. If such issues become widespread it could hurt our reputation and we could potentially lose
customers which would adversely affect our business.
Also, given the issue of temperature sensitivity, time in transit may limit our ability to service potential markets outside of the U.S. for
those products, especially those with geographies that do not allow for shipment and customs clearance within four business days.
This could adversely affect our potential to generate revenue for some products on an international level.
We are subject to environmental, health and safety laws, which could increase our costs and restrict our operations in the future.
Our operations are subject to environmental, health and safety laws and regulations in each of the jurisdictions in which we operate.
These laws and regulations concern, among other things, the generation, handling, transportation and disposal of hazardous substances
or wastes, the clean-up of hazardous substance releases, and the emission or discharge of materials into the air or water. Although we
currently incur limited expenditures in connection with these environmental health and safety laws and regulations, if we fail to
comply with the requirements of such laws and regulations or if such laws changes significantly in the future, we could incur
substantial additional costs to alter our manufacturing processes and/or adjust our supply chain management. Such changes could also
result in significant inventory obsolescence. Compliance with environmental, health and safety requirements could also restrict our
ability to expand our facilities in the future.
28
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Our business is vulnerable to inflation.
We are limited in our ability to raise prices for some products, particularly in the clinical laboratory marketplace where
cost-containment pressures are significant. As a result, increases in our raw materials, production and transportation costs may have a
material adverse impact on our results of operations.
Demands of third-party payors, cost reduction pressures among our customers and restrictive reimbursement practices may
adversely affect our revenue.
Our ability to negotiate favorable contracts with non-governmental payors, including managed-care plans or Group Purchasing
Organizations (“GPOs”), even if facilitated by our distributors, may significantly affect revenue and operating results. Our customers
continue to face cost reduction pressures that may cause them to curtail their use of, or reimbursement for some of our products, to
negotiate reduced fees or other concessions or to delay payment. Furthermore, the increasing leverage of organized buying groups
among non-governmental payors may reduce market prices for our products and services, thereby reducing our profitability.
Reductions in price increases or the amounts received from current customers or lower pricing for our products to new customers
could have a material adverse effect on the financial position, cash flows and results of operations.
Failure to obtain medical reimbursement for our products under development, as well as a changing regulatory and
reimbursement environment, may impact our business.
The U.S. healthcare regulatory environment may change in a way that restricts our ability to market our products due to medical
coverage or reimbursement limits. Sales of our diagnostic tests will depend in part on the extent to which the costs of such tests are
covered by health maintenance, managed care, and similar healthcare management organizations, or reimbursed by government health
payor administration authorities, private health coverage insurers and other third-party payors. These healthcare payors are
increasingly challenging the prices charged for medical products and services. The containment of healthcare costs has become a
priority of federal and state governments. Accordingly, our potential products may not be considered to be cost effective, and
reimbursement may not be available or sufficient to allow us to sell our products on a competitive basis. Legislation and regulations
affecting reimbursement for our products may change at any time and in ways that are difficult to predict and these changes may be
adverse to us.
CMS, the federal agency responsible for administering the Medicare program, along with its contractors establishes coverage and
reimbursement policies for the Medicare program. In addition, private payors often follow the coverage and reimbursement policies of
Medicare. We cannot assure you that government or private third-party payors will cover and reimburse the procedures using our
products in whole or in part in the future or that payment rates will be adequate.
For some of our products, our success in non-U.S. markets may depend upon the availability of coverage and reimbursement from the
third-party payors through which health care providers are paid in those markets. Health care payment systems in non-U.S. markets
vary significantly by country, and include single-payor, government managed systems as well as systems in which private payors and
government-managed systems exist, side-by-side. For some of our products, our ability to achieve market acceptance or significant
sales volume in international markets may be dependent on the availability of reimbursement for our products under health care
payment systems in such markets. There can be no assurance that reimbursement for our products, will be obtained or that such
reimbursement will be adequate.
29
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Health care legislation, including the Patient Protection and Affordable Care Act and the Health Insurance Portability and
Accountability Act of 1996, may have a material adverse effect on us.
The Patient Protection and Affordable Care Act (“PPACA”) substantially changes the way healthcare is financed by government and
private insurers, encourages improvements in healthcare quality, and impacts the medical device industry. The PPACA includes an
excise tax on entities that manufacture or import medical devices offered for sale in the United States; a new Patient-Centered
Outcomes Research Institute to conduct comparative effectiveness research; and payment system reforms.
The PPACA also imposes new reporting and disclosure requirements on device and drug manufacturers for any payment or transfer of
value made or distributed to physicians or teaching hospitals. Under these provisions, known as the Physician Payment Sunshine Act,
affected device and drug manufacturers need to begin data collection on August 1, 2013, with the first reports due in 2014. These
provisions require, among other things, extensive tracking and maintenance of databases regarding the disclosure of relationships and
payments to physicians and teaching hospitals. In addition, certain states have passed or are considering legislation restricting our
interactions with health care providers and/or requiring disclosure of many payments to them. Failure to comply with these tracking
and reporting laws could subject us to significant civil monetary penalties.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) created new federal statutes to prevent healthcare fraud
and false statements relating to healthcare matters. The healthcare fraud statute prohibits knowingly and willfully executing a scheme
to defraud any healthcare benefit program, including private payors. A violation of this statute is a felony and may result in fines,
imprisonment or exclusion from government sponsored programs such as the Medicare and Medicaid programs. The false statements
statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious
or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this
statute is a felony and may result in fines or imprisonment or exclusion from government sponsored programs. HIPAA also
established uniform standards governing the conduct of certain electronic healthcare transactions and protecting the security and
privacy of individually identifiable health information maintained or transmitted by healthcare providers, health plans and healthcare
clearinghouses.
Both federal and state government agencies are continuing heightened and coordinated civil and criminal enforcement efforts. As part
of announced enforcement agency work plans, the federal government will continue to scrutinize, among other things, the billing
practices of hospitals and other providers of healthcare services. The federal government also has increased funding to fight healthcare
fraud, and it is coordinating its enforcement efforts among various agencies, such as the U.S. Department of Justice, the Office of
Inspector General and state Medicaid fraud control units. We believe that the healthcare industry will continue to be subject to
increased government scrutiny and investigations.
We may fail to recruit and retain qualified personnel.
We expect to rapidly expand our operations and grow our sales, development and administrative operations. This expansion is
expected to place a significant strain on our management and will require hiring a significant number of qualified personnel.
Accordingly, recruiting and retaining such personnel in the future will be critical to our success. There is intense competition from
other companies for qualified personnel in the areas of our activities, particularly sales, marketing and research & development. If we
fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our marketing and
development activities, and this could have a material adverse effect on the Company’s business, financial condition, results of
operations and future prospects.
We may face risks in connection with potential acquisitions.
We may look to acquire businesses that complement or expand our operations as part of our business strategy going forward. We may
not be able to successfully identify attractive acquisition candidates or negotiate favorable terms in the future. Furthermore, our ability
to effectively integrate any future acquisitions will depend on, among other things, the adequacy of our implementation plans, the
ability of our management to oversee and operate effectively the combined operations and our ability to achieve desired operational
efficiencies. If we are unable to successfully integrate the operations of any businesses that we may acquire in the future, our business,
financial position, results of operations or cash flows could be adversely affected.
30
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
We rely on key executive officers, and their knowledge of our business and technical expertise would be difficult to replace.
We are highly dependent on our Executive Chairman, Raymond F. Akers, Jr., PhD because of his expertise and experience in
biotechnology and diagnostics. We do not have “key person” life insurance policies for any of our officers. The loss of the technical
knowledge, management and industry expertise of any of our key personnel could result in delays in product development, loss of
customers and sales and diversion of management resources, which could adversely affect our operating results.
We may need to obtain additional licenses to patents or other proprietary rights from other parties.
To facilitate development and commercialization of a proprietary technology base, we may need to obtain additional licenses to
patents or other proprietary rights from other parties. Obtaining and maintaining these licenses, which may not be available, may
require the payment of up-front fees and royalties. In addition, if we are unable to obtain these types of licenses, our product
development and commercialization efforts may be delayed or precluded.
We may not be able to protect or enforce our intellectual property rights, which could impair our competitive position.
Our success depends significantly on our ability to protect our rights to the patents, trademarks, trade secrets, copyrights and all other
intellectual property rights used in our products. Protecting our intellectual property rights is costly and time consuming. We rely
primarily on patent protection and trade secrets, as well as a combination of copyright and trademark laws and nondisclosure and
confidentiality agreements to protect our technology and intellectual property rights. However, these legal means afford only limited
protection and may not adequately protect our rights or permit us to gain or maintain any competitive advantage. Despite our
intellectual property rights practices, it may be possible for a third party to copy or otherwise obtain and use our technology without
authorization, develop similar technology independently or design around our patents.
We cannot be assured that any of our pending patent applications will result in the issuance of a patent to us. The U.S. Patent and
Trademark Office, or PTO, may deny or require significant narrowing of claims in our pending patent applications, and patents issued
as a result of the pending patent applications, if any, may not provide us with significant commercial protection or be issued in a form
that is advantageous to us. We could also incur substantial costs in proceedings before the PTO. Our issued and licensed patents and
those that may be issued or licensed in the future may expire or may be challenged, invalidated or circumvented, which could limit our
ability to stop competitors from marketing related technologies. Upon expiration of our issued or licensed patents, we may lose some
of our rights to exclude others from making, using, selling or importing products using the technology based on the expired patents.
There is no assurance that competitors will not be able to design around our patents. We also rely on unpatented proprietary
technology. We cannot assure you that we can meaningfully protect all our rights in our unpatented proprietary technology or that
others will not independently develop substantially equivalent proprietary products or processes or otherwise gain access to our
unpatented proprietary technology. Further, we may not be able to obtain patent protection or secure other intellectual property rights
in all the countries in which we operate, and under the laws of such countries, patents and other intellectual property rights may be
unavailable or limited in scope. If any of our patents fail to protect our technology, it would make it easier for our competitors to offer
similar products. Our trade secrets may be vulnerable to disclosure or misappropriation by employees, contractors and other persons.
Any inability on our part to adequately protect our intellectual property may have a material adverse effect on our business, financial
condition and results of operations.
Expenses incurred with respect to monitoring, protecting, and defending our intellectual property rights could adversely affect our
business.
Competitors and others may infringe on our intellectual property rights, or may allege that we have infringed on theirs. Monitoring
infringement and misappropriation of intellectual property can be difficult and expensive, and we may not be able to detect
infringement or misappropriation of our proprietary rights.
31
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights
and we may be unable to protect our rights to, or use of, our technology.
Some or all of our patent applications may not result in the issue of patents, or the claims of any issued patents may not afford
meaningful protection for our technologies or products. In addition, patents issued to us or our licensors, if any, may be challenged
and subsequently narrowed, invalidated, found unenforceable or circumvented. Patent litigation is widespread in the biotechnology
industry and could harm our business. Litigation might be necessary to protect our patent position. Patentability, invalidity,
freedom-to-operate or other opinions may be required to determine the scope and validity of third-party proprietary rights. If we
choose to go to court to stop a third party from using the inventions protected by our patent, that third party would have the right to
ask the court to rule that such patents are invalid and/or should not be enforced against that third party. These lawsuits are expensive
and we may not have the required resources to pursue such litigation or to protect our patent rights. In addition, there is a risk that the
court will decide that our patents are not valid or that we cannot stop the other party from using their inventions. There is also the risk
that, even if the validity of these patents is upheld, the court will find that the third party’s activities do not infringe our rights in these
patents.
Furthermore, a third party may claim that we are infringing the third party’s patent rights and may go to court to stop us from
engaging in our normal operations and activities, including making or selling our product candidates. These lawsuits are costly and
could affect our results of operations and divert the attention of managerial and technical personnel. There is a risk that a court would
decide that we are infringing the third party’s patents and would order us to stop the activities covered by the patents. In addition,
there is a risk that a court will order us to pay the other party’s treble damages or attorneys’ fees for having violated the other party’s
patents. The biotechnology industry has produced a proliferation of patents, and it is not always clear to industry participants,
including us, which patents cover various types of products or methods of use. The coverage of patents is subject to interpretation by
the courts, and the interpretation is not always uniform. If we are sued for patent infringement, we would need to demonstrate that our
products or methods of use either do not infringe the claims of the relevant patent and/or that the third party patent claims are invalid,
and we may not be able to do this. Proving invalidity in the United Sates, in particular, is difficult since it requires a showing of clear
and convincing evidence to overcome the presumption of validity enjoyed by issued patents.
In addition, changes in either patent laws or in interpretations of patent laws in the United States and other countries may materially
diminish the value of our intellectual property or narrow the scope of our patent protection. In September 2011, the U.S. Congress
passed the Leahy-Smith America Invents Act (“AIA”) which became effective in March 2013. The AIA reforms United States patent
law in part by changing the standard for patent approval for certain patents from a “first to invent” standard to a “first to file” standard
and developing a post-grant review system. It is too early to determine what the effect or impact the AIA will have on the operation of
our business and the protection and enforcement of our intellectual property. However, the AIA and its implementation could increase
the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents,
all of which could have a material adverse effect on our business and financial condition. Because some patent applications in the
United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign
jurisdictions are typically not published until eighteen months after filing, and publications in the scientific literature often lag behind
actual discoveries. We cannot be certain that others have not filed patent applications for technology covered by our issued patents or
our pending applications or that we were the first to invent the technology (pre-AIA) or first to file (post-AIA). Our competitors may
have filed, and may in the future file, patent applications covering technology similar or the same as ours. Any such patent application
may have priority over our patent application and could further require us to obtain rights to such technologies in order to carry on our
business. If another party has filed a U.S. patent application on inventions similar or the same as ours, we may have to participate in an
interference or other proceeding in the U.S. Patent and Trademark Office, or the USPTO, or a court to determine priority of invention
in the United States, for pre-AIA applications and patents. The costs of these proceedings could be substantial, and it is possible that
such efforts would be unsuccessful, resulting in a loss of our U.S. patent position with respect to such inventions. Some of our
competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially
greater resources.
32
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Our failure to secure trademark registrations could adversely affect our ability to market our product candidates and our business.
Our trademark applications in the United States and any other jurisdictions where we may file may not be allowed registration, and we
may not be able to maintain or enforce our registered trademarks. During trademark registration proceedings, we may receive
rejections. Although we are given an opportunity to respond to those rejections, we may be unable to overcome such rejections. In
addition, in the USPTO and in corresponding foreign agencies, third parties are given an opportunity to oppose pending trademark
applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against our applications
and/or registrations, and our applications and/or registrations may not survive such proceedings. Failure to secure such trademark
registrations in the United States and in foreign jurisdictions could adversely affect our ability to market our product candidates and
our business.
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other
biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although the Company has no
knowledge of any claims against us, we may be subject to claims that these employees or the Company have inadvertently or
otherwise used or disclosed trade secrets or other proprietary information of their former employers. Litigation may be necessary to
defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and
be a distraction to management. To date, none of our employees have been subject to such claims.
We may not be able to adequately protect our intellectual property outside of the United States.
The laws in some foreign jurisdictions may not provide protection for our trade secrets and other intellectual property. If our trade
secrets or other intellectual property are misappropriated in foreign jurisdictions, we may be without adequate remedies to address
these issues. Additionally, we also rely on confidentiality and assignment of invention agreements to protect our intellectual property.
These agreements may provide for contractual remedies in the event of misappropriation. We do not know to what extent, if any, these
agreements and any remedies for their breach, will be enforced by a foreign or domestic court. In the event our intellectual property is
misappropriated or infringed upon and an adequate remedy is not available, our future prospects will likely diminish.
Additionally, prosecuting and maintaining intellectual property, particularly patent rights, are very costly endeavors. We do not know
whether legal and government fees will increase substantially and therefore are unable to predict whether cost may factor into our
intellectual property strategy.
If we deliver products with defects, we may be subject to product recalls or negative publicity, our credibility may be harmed,
market acceptance of our products may decrease and we may be exposed to liability.
The manufacturing and marketing of professional and consumer diagnostics involve an inherent risk of product liability claims. For
example, a defect in one of our diagnostic products could lead to a false positive or false negative result, affecting the eventual
diagnosis. Our product development and production are extremely complex and could expose our products to defects. Manufacturing
and design defects could lead to recalls, either voluntary or required by the FDA or other government authorities, and could result in
the removal of a product from the market. Defects in our products could also harm our reputation, lead to product liability claims,
claims that inaccurate test results lead to death or injury, negative publicity and decrease sales of our products. We have obtained
$10,000,000 of product liability insurance and we have never received a product liability claim, and have generally not seen product
liability claims for screening tests that are accompanied by appropriate disclaimers. However, in the event there is a claim, this
insurance may not fully cover our potential liabilities. In addition, as we attempt to bring new products to market, we may need to
increase our product liability coverage which would be a significant additional expense that we may not be able to afford. If we are
unable to obtain sufficient insurance coverage at an acceptable cost to protect us, we may be forced to abandon efforts to
commercialize our products or those of our strategic partners, which would reduce our revenue.
33
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
If our estimates relating to our critical accounting policies are based on assumptions or judgments that change or prove to be
incorrect, our operating results could fall below expectations of financial analysts and investors, resulting in a decline in our stock
price.
The preparation of financial statements in conformity with U.S. GAAP requires our management to make estimates, assumptions and
judgments that affect the amounts reported in the financial statements and accompanying notes. We base our estimates on historical
experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets, liabilities, equity, revenue and expenses that are not readily apparent
from other sources. Our operating results may be adversely affected if our assumptions change or if actual circumstances differ from
those in our assumptions, which could cause our operating results to fall below the expectations of financial analysts and investors,
resulting in a decline in our stock price. Significant assumptions and estimates used in preparing our financial statements include those
related to revenue recognition, inventory, product warranties, allowances for doubtful accounts, stock-based compensation expense
and income taxes.
As an emerging growth company within the meaning of the Securities Act, we will utilize certain modified disclosure requirements,
and we cannot be certain if these reduced requirements will make our common stock less attractive to investors.
We are an emerging growth company within the meaning of the rules under the Securities Act. We have utilized, and we plan in future
filings with the SEC to continue to utilize, the modified disclosure requirements available to emerging growth companies, including
reduced disclosure about our executive compensation and omission of compensation discussion and analysis, and an exemption from
the requirement of holding a nonbinding advisory vote on executive compensation. In addition, we will not be subject to certain
requirements of Section 404 of the Sarbanes-Oxley Act, including the additional testing of our internal control over financial reporting
as may occur when outside auditors attest as to our internal control over financial reporting, and we have elected to delay adoption of
new or revised accounting standards applicable to public companies. As a result, our stockholders may not have access to certain
information they may deem important.
In addition, Section 107 of the JOBS Act also provides that an emerging growth company can utilize the extended transition period
provided in Section 7(a)(2)(B) of the Securities Act which allows us to delay the adoption of compliance with new or revised
accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards
would otherwise apply to private companies. We have elected to utilize this extended transition period. Our financial statements may
therefore not be comparable to those of companies that comply with such new or revised accounting standards as they become
applicable to public companies. We cannot predict if investors will find our common stock less attractive because we will rely on
these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our
common stock and our stock price may be more volatile.
We could remain an “emerging growth company” for up to five years, or until the earliest of (i) the last day of the first fiscal year in
which our annual gross revenue exceeds $1 billion, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2
under the Exchange Act, which would occur if the market value of our common stock that is held by non-affiliates exceeds $700
million as of the last business day of our most recently completed second fiscal quarter or (iii) the date on which we have issued more
than $1 billion in non-convertible debt during the preceding three-year period.
We have not performed an evaluation of our internal control over financial reporting, such as required by Section 404 of the
Sarbanes-Oxley Act, nor have we engaged our independent registered public accounting firm to perform an audit of our internal
control over financial reporting as of any balance sheet date or for any period reported in our financial statements. Had we performed
such an evaluation or had our independent registered public accounting firm performed an audit of our internal control over financial
reporting, material weaknesses may have been identified. For so long as we qualify as an “emerging growth company” under the
JOBS Act, we will not have to provide an auditor’s attestation report on our internal controls in future annual reports on Form 10-K as
otherwise required by Section 404(b) of the Sarbanes-Oxley Act. During the course of the evaluation, documentation or attestation, we
or our independent registered public accounting firm may identify weaknesses and deficiencies that we may not otherwise identify in a
timely manner or at all as a result of the deferred implementation of this additional level of review.
34
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Our legal counsel has advised us that we may have violated Section 402 of the Sarbanes-Oxley Act of 2002, which prohibits an
issuer from extending or maintaining personal loans to its directors or executive officers. As a result, we could become subject to
criminal, civil or administrative sanctions or penalties and we may also face potential private securities litigation.
On September 14, 2012, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with Mr. Thomas J.
Knox. Pursuant to the Purchase Agreement, Mr. Knox purchased, amongst other things, 10,000,000 shares of the Series A Preferred
Stock. The Series A Preferred Stock were convertible at any time into 320,512 shares of common stock. The Company requested that
Mr. Knox convert the Series A Preferred Stock, and though under no obligation to do so, on November 15, 2013, Mr. Knox converted
all 10,000,000 shares of Series A Preferred Stock into 320,512 shares of common stock pursuant to the terms of the Series A Preferred
Stock. In order to satisfy the required onetime payment of $500,000 (the “Purchase Price”) due upon conversion as set forth in the
Purchase Agreement, Mr. Knox issued a promissory note in favor of the Company for the principal aggregate amount of $500,000 (the
“2013 Knox Note”). The 2013 Knox Note required payment of the principal in full prior to maturity date of November 15, 2014 (the
“Maturity Date”) with interest on the unpaid principal balance at the rate of the thirty day average LIBOR per annum commencing on
November 15, 2013. The 320,512 shares of common stock were to be held by the Company as collateral until all amounts owing
under the 2013 Knox Note were paid in full.
We have taken immediate steps to address the above situation by cancelling the 2013 Knox Note and seeking immediate repayment
from Mr. Knox. On December 3, 2013 the Company issued Mr. Knox 261,997 shares of common stock and cancelled the remaining
shares issuable to him under the terms of the Series A Preferred Stock in full satisfaction of the Purchase Price. Section 402 of the
Sarbanes-Oxley Act of 2002 prohibits public U.S. companies, including us, from extending or maintaining personal loans to its
directors or executive officers. The arrangements with Mr. Knox may have violated this prohibition. The potential violation of the
Section 402 may cause governmental authorities, such as the SEC or other U.S. authorities, to impose certain criminal, civil, and
administrative sanctions or penalties upon us. Similarly, private parties may also bring civil litigations against us for such violations.
Risks Related to the Market
Recent global economic trends could adversely affect our business, liquidity and financial results.
Recent global economic conditions, including a disruption of financial markets, could adversely affect us, primarily through limiting
our access to capital. In addition, the continuation or worsening of general market conditions in economies important to our businesses
may adversely affect our clients’ level of spending and ability to obtain financing, leading to us being unable to generate the levels of
sales that we require. Current and continued disruption of financial markets could have a material adverse effect on the Company’s
business, financial condition, results of operations and future prospects.
Risks Relating to our Common Stock
We currently have a limited trading volume, which results in higher price volatility for, and reduced liquidity of, our common
stock.
There has been limited trading of our common stock in the U.S since we began trading on the NASDAQ Capital Market in January
2014. Since 2002, our shares of common stock have been listed for trading on AIM. However, historically there has been limited
volume of trading in our common stock on AIM, which has limited the liquidity of our common stock on that market. We cannot
predict whether or how investor interest in our common stock on the AIM market might translate to the market price of our common
stock or the development of an active trading market in the U.S. or how liquid that market might become.
Furthermore, if we cease to be listed on AIM or NASDAQ, holders would find it more difficult to dispose of, or to obtain accurate
quotations as to the market value of, our common stock, and the market value of our common stock would likely decline.
35
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
If and when a larger trading market for our common stock develops, the market price of our common stock is still likely to be
highly volatile and subject to wide fluctuations, and you may be unable to resell your shares at or above the price at which you
acquired them.
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:
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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; 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.
Our common stock is listed on two separate stock markets and investors seeking to take advantage of price differences between
such markets may create unexpected volatility in our share price; in addition, investors may not be able to easily move shares for
trading between such markets.
Our common stock is already admitted to trading on AIM and the NASDAQ Capital Market. Price levels for our ordinary shares could
fluctuate significantly on either market, independent of our share price on the other market. Investors could seek to sell or buy our
shares to take advantage of any price differences between the two markets through a practice referred to as arbitrage. Any arbitrage
activity could create unexpected volatility on either exchange with respect to both our share price and the volume of shares available
for trading. In addition, holders of shares in either jurisdiction will not be immediately able to transfer such shares for trading on the
other market without effecting necessary procedures with our transfer agent. This could result in time delays and additional cost for
our shareholders. Further, if we are unable to continue to meet the regulatory requirements for listing on AIM or NASDAQ, we may
lose our listing on AIM or NASDAQ, which could impair the liquidity of our shares.
Our stock price could fall and we could be delisted from the NASDAQ in which case U.S. broker-dealers may be discouraged from
effecting transactions in shares of our common stock because they may be considered penny stocks and thus be subject to the
penny stock rules.
The SEC has adopted a number of rules to regulate “penny stock” that restricts transactions involving stock which is deemed to be
penny stock. Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Securities and
Exchange Act of 1934, as amended. These rules may have the effect of reducing the liquidity of penny stocks. “Penny stocks”
generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities
exchanges or quoted on the NASDAQ Stock Market if current price and volume information with respect to transactions in such
securities is provided by the exchange or system). Our securities have in the past constituted, and may again in the future constitute,
“penny stock” within the meaning of the rules. The additional sales practice and disclosure requirements imposed upon U.S.
broker-dealers may discourage such broker-dealers from effecting transactions in shares of our common stock, which could severely
limit the market liquidity of such shares and impede their sale in the secondary market.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
36
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
A U.S. broker-dealer selling penny stock to anyone other than an established customer or “accredited investor” (generally, an
individual with net worth in excess of $1,000,000 or an annual income exceeding $200,000, or $300,000 together with his or her
spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to the
transaction prior to sale, unless the broker-dealer or the transaction is otherwise exempt. In addition, the “penny stock” regulations
require the U.S. broker-dealer to deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in
accordance with SEC standards relating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt.
A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and
current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price
information with respect to the “penny stock” held in a customer’s account and information with respect to the limited market in
“penny stocks”.
Stockholders should be aware that, according to SEC, the market for “penny stocks” has suffered in recent years from patterns of
fraud and abuse. Such patterns include (i) control of the market for the security by one or a few broker-dealers that are often related to
the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press
releases; (iii) “boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales
persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of
the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, resulting in investor losses.
Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in
a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the
confines of practical limitations to prevent the described patterns from being established with respect to our securities.
We have not paid dividends in the past and do not expect to pay dividends for the foreseeable future, and any return on investment
may be limited to potential future appreciation on the value of our common stock.
We currently intend to retain any future earnings to support the development and expansion of our business and do not anticipate
paying cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our board of directors
after taking into account various factors, including without limitation, our financial condition, operating results, cash needs, growth
plans and the terms of any credit agreements that we may be a party to at the time. To the extent we do not pay dividends, our stock
may be less valuable because a return on investment will only occur if and to the extent our stock price appreciates, which may never
occur. In addition, investors must rely on sales of their common stock after price appreciation as the only way to realize their
investment, and if the price of our stock does not appreciate, then there will be no return on investment. Investors seeking cash
dividends should not purchase our common stock.
Non-U.S. investors may have difficulty effecting service of process against us or enforcing judgments against us in courts of
non-U.S. jurisdictions.
We are a company incorporated under the laws of the State of New Jersey. All of our directors and officers reside in the United States.
It may not be possible for non-U.S. investors to effect service of process within their own jurisdictions upon our company and our
directors and officers. In addition, it may not be possible for non-U.S. investors to collect from our company, its directors and officers,
judgments obtained in courts in such non-U.S. jurisdictions predicated on non-U.S. legislation.
37
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if
they change their recommendations regarding our stock adversely, our stock price and trading volume could decline.
The trading market for our common stock will be influenced by the research and reports that industry or securities analysts may
publish about us, our business, our market or our competitors. If any of the analysts who may cover us change their recommendation
regarding our stock adversely, or provide more favorable relative recommendations about our competitors, our stock price would
likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we
could lose visibility in the financial markets, which in turn could cause our stock price or trading volume to decline.
The requirements of being a U.S. public company may strain our resources and divert management’s attention.
As a U.S. public company, we will be or become subject to the reporting requirements of the Securities Exchange Act of 1934, as
amended (“Exchange Act”), the Sarbanes-Oxley Act, the Dodd-Frank Act, the listing requirements of NASDAQ, and other applicable
securities rules and regulations. Compliance with these rules and regulations will increase our legal and financial compliance costs,
make some activities more difficult, time-consuming, or costly, and increase demand on our systems and resources. The Exchange Act
requires, among other things, that we file annual and current reports with respect to our business and operating results.
As a result of disclosure in filings required of a public company, our business and financial condition will become more visible, which
we believe may result in threatened or actual litigation, including by competitors and other third parties. If such claims are successful,
our business and operating results could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these
claims, and the time and resources necessary to resolve them, could divert resources of our management and harm our business and
operating results.
We will incur significant costs as a result of being a publicly traded company and such costs may increase when we cease to be an
emerging growth company.
As a publicly traded company, we will incur legal, accounting and other expenses estimated to range from $250,000 to $350,000 per
year, including costs associated with the periodic reporting requirements applicable to a company whose securities are registered
under the Exchange, as well as additional corporate governance requirements, including applicable requirements under the
Sarbanes-Oxley Act and other rules implemented by the SEC. The expenses incurred by public companies generally for reporting and
corporate governance purposes have been increasing. We expect compliance with these public reporting requirements and associated
rules and regulations to increase our legal and financial costs, particularly after we are no longer an emerging growth company, and to
make some activities more time-consuming and costly, although we are currently unable to estimate these costs with any degree of
certainty. These laws and regulations could also make it more difficult or costly for us to obtain certain types of insurance, including
director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially
higher costs to obtain the same or similar coverage. These laws and regulations could also make it more difficult for us to attract and
retain qualified persons to serve on our board of directors, our board committees or as our executive officers. Further, if we are unable
to satisfy our obligations as a public company, we could be subject to delisting of our common stock, fines, sanctions and other
regulatory action and, potentially, civil litigation.
The recently enacted JOBS Act reduces certain disclosure requirements for emerging growth companies, thereby decreasing related
regulatory compliance costs. We qualify as an emerging growth company. However, when we cease to be an emerging growth
company, we will be unable to take advantage of the reduced regulatory requirements and any associated cost savings.
38
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Efforts to comply with the applicable provisions of Section 404 of the Sarbanes-Oxley Act will involve significant expenditures, and
non-compliance with Section 404 of the Sarbanes-Oxley Act may adversely affect us and the market price of our common stock.
Under current SEC rules, beginning with our fiscal year ending December 31, 2014, we will be required to report on our internal
control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act, and related rules and regulations of the SEC;
although, as an emerging growth company, we are exempt from the requirement to provide an auditor attestation to management’s
assessment of its internal controls as required by Section 404(b) of the Sarbanes-Oxley Act. We will be required to review on an
annual basis our internal control over financial reporting, and on a quarterly and annual basis to evaluate and disclose changes in our
internal control over financial reporting. As a result, we expect to incur additional expenses in the near term that may negatively
impact our financial performance and our ability to make distributions. This process also will result in a diversion of management’s
time and attention. We cannot be certain as to the timing of completion of our evaluation, testing and remediation actions or the
impact of the same on our operations, and we may not be able to ensure that the process is effective or that our internal control over
financial reporting is or will be effective in a timely manner. In the event that we are unable to maintain or achieve compliance with
the applicable provisions of Section 404 of the Sarbanes-Oxley Act and related rules, we and the market price of our common stock
may be adversely affected.
Item 1B. Unresolved Staff Comments.
Not applicable.
Item 2. Property.
Our corporate headquarters which houses our research and development, engineering, manufacturing, operations and support
personnel, is located in Thorofare, New Jersey, in an office consisting of a total of 12,500 square feet. For the past ten years, the
Company has leased this facility at this location. The current lease term is effective from January 1, 2013 through December 31, 2019
with an annual rent of $132,000.
We believe our current facilities are sufficient for our current needs and will be adequate, or that suitable additional or substitute space
will be available on commercially reasonable terms, for the foreseeable future.
Item 3. 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 April 23, 2015, a complaint was filed by the Company in federal district court (District of New Jersey) against ChubeWorkx
Guernsey Limited (“ChubeWorkx”) for breach of contract (the “Breach of Contract Claim”) for failure of timely interest payments by
ChubeWorkx under a promissory note (the “Chube Note”) entered into by the Company and ChubeWorkx in December 2014. As part
of this action, the Company also filed a preliminary injunction which sought to bar ChubeWorkx from disposing of the Company’s
common stock owned by ChubeWorkx for which the Company retained a right of sale in the event of a default by ChubeWorkx under
the Chube Note. A consent decree was entered by the court to resolve the issues of the preliminary injunction which requirds
ChubeWorkx to escrow a certain of number of shares of the Company’s common stock currently held by ChubeWorkx until the
Breach of Contract Claim has been fully adjudicated. The Breach of Contract Claim is currently in the discovery phase and while the
parties have communicated in good faith to resolve this dispute all discussions to date have not yielded any results. Pursuant to a
request from the Company, this case was closed by the Court pursuant to an order entered on December 22, 2015 in light of
discussions with Chubeworks related to the final settlement and release of all claims between the parties. The settlement discussions
were terminated on March 24, 2016 after substantial good faith efforts by the Company to bring this dispute to a resolution. The
Company will seek to reopen the case and pursue all legal remedies available to retrieve the monies owed to the Company.
On August 21, 2015, Chubeworkx filed a lawsuit against the Company in The High Court of Justice, Queen’s Bench Division
Commercial Court, Royal Courts of Justice, United Kingdom, alleging a breach of contract under the exclusive license agreement
entered into by Chubeworkx with Company in June 2012 and damages resulting from said alleged breach. The lawsuit is in the
preliminary stage and was suspended by mutual agreement of the parties pursuant to ongoing global settlement discussions which
were focused on settling all outstanding claims between the parties. The settlement discussions were terminated on March 24, 2016.
As a result, As a result, the Company intends to vigorously defend itself against Chubeworkx claims. The Company will take all legal
action necessary to protect the interests of the Company and its shareholders.
With the exception of the foregoing dispute, the Company is not involved in any disputes and does not have any litigation matters
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
pending.
Item 4. Mine Safety Disclosures.
Not applicable.
39
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
PART II
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
(a) Market Information
We began trading on The NASDAQ Capital Market on January 23, 2014 and have not been previously listed on any other U.S.
market. However, our shares are currently listed on AIM under the symbol “AKR.L”. Our shares began trading on AIM in May 2002.
The following table shows the high and low market prices on NASDAQ, for our shares since for each fiscal quarter for the two most
recent fiscal years. Market prices for our shares have fluctuated significantly since they were listed on NASDAQ and trading volume
on NASDAQ have been very small in relation to the number of our total outstanding shares.
Quarter ended
March 31, 2016*
December 31, 2015
September 30, 2015
June 30, 2015
March 31, 2015
December 31, 2014
September 30, 2014
June 30, 2014
March 31, 2014
*Through March 24, 2016
$
Low Price
High Price
1.08 $
1.12
2.27
3.65
3.08
2.62
2.88
3.19
4.53
2.47
3.73
4.54
5.28
4.85
3.99
4.97
4.33
5.51
The following table shows the high and low market prices on AIM, for our shares for each fiscal quarter for the two most recent fiscal
years. Market prices for our shares have fluctuated significantly since they were listed on AIM and trading volume on AIM have been
very small in relation to the number of our total outstanding shares.
Quarter Ended
March 31, 2016*
December 31, 2015
September 30, 2015
June 30, 2015
March 31, 2015
December 31, 2014
September 30, 2014
June 30, 2014
March 31, 2014
£
Low Price
High Price
Exchange
GBP
USD
GBP
USD
Rate
0.79 $
0.83
1.41
2.60
2.10
2.18
2.08
2.65
2.90
1.13 £
1.26
2.18
3.98
3.18
3.44
4.46
4.80
3.44
1.50 $
2.09
2.83
3.30
2.83
2.70
3.15
3.15
4.85
2.15 $
3.17
4.38
5.06
4.29
4.27
5.26
5.30
8.03
1.4329
1.5173
1.5492
1.5320
1.5146
1.5831
1.6707
1.6824
1.6548
* The most recent quarter is accurate through March 24, 2016. The Company’s stock is listed on the AIM where stock prices are in
pounds. All shares prices in the table above are reflected in dollars after having been converted according to the periods average
exchange rates.
40
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
(b) Holders
As of March 29, 2016, there were approximately 600 holders of record of our common stock. This figure does not take into account
those shareholders whose certificates are held in the name of broker-dealers or other nominees.
(c) Dividends
We have never paid any cash dividends on our common shares, and we do not anticipate that we will pay any dividends with respect
to those securities in the foreseeable future. Our current business plan is to retain any future earnings to finance the expansion
development of our business.
(d) Securities Authorized for Issuance under Equity Compensation Plan
The following table shows information with respect this plan as of the fiscal year ended December 31, 2015.
Equity Compensation Plan Information
Number of
securities to
be issued
upon
exercise
of
outstanding
options,
warrants
and
rights (a)
Weighted-
average
Exercise
price
of
outstanding
options,
warrants
and
rights (b)
Number of
securities
remaining
available
for
future
issuance
under
equity
compensation
plans
(excluding
securities
reflected in
column (a))
(c)
Plan category
Equity compensation plans approved by security holders
- $
Equity compensation plans not approved by security holders
Total
220,500 $
220,500 $
-
4.38
4.38
-
49,292
49,292
41
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Transfer Agent
Our transfer agent is VStock Transfer LLC, 18 Lafayette Place Woodmere, NY 11598.
Recent Sales of Unregistered Securities
During the year ended December 31, 2015, there were no sales of unregistered securities by the Company.
Rule 10B-18 Transactions
During the year ended December 31, 2015, there were no repurchases of the Company’s common stock by the Company.
Item 6. Selected Financial Data.
Not applicable.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
THE FOLLOWING DISCUSSION OF OUR PLAN OF OPERATION AND RESULTS OF OPERATIONS SHOULD BE READ IN
CONJUNCTION WITH THE FINANCIAL STATEMENTS AND RELATED NOTES TO THE FINANCIAL STATEMENTS
INCLUDED ELSEWHERE IN THIS REPORT. THIS DISCUSSION CONTAINS FORWARD-LOOKING STATEMENTS THAT
RELATE TO FUTURE EVENTS OR OUR FUTURE FINANCIAL PERFORMANCE. THESE STATEMENTS INVOLVE
KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS THAT MAY CAUSE OUR ACTUAL
RESULTS, LEVELS OF ACTIVITY, PERFORMANCE OR ACHIEVEMENTS TO BE MATERIALLY DIFFERENT FROM ANY
FUTURE RESULTS, LEVELS OF ACTIVITY, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY THESE
FORWARD-LOOKING STATEMENTS. THESE RISKS AND OTHER FACTORS INCLUDE, AMONG OTHERS, THOSE
LISTED UNDER “FORWARD-LOOKING STATEMENTS” AND “RISK FACTORS” AND THOSE INCLUDED ELSEWHERE
IN THIS REPORT.
Results of Operations
Management’s Plans and Basis of Presentation
To date, the Company has in large part relied on equity financing to fund its operations, recently raising $13,101,336, net of expenses,
in an initial public offering on the NASDAQ Stock Exchange in 2014. The Company continues to experience 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.
42
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Despite our plans, the Company expects to continue to incur losses from operations for the near-term and these losses could be
significant for the following reasons:
●
●
●
some of Akers’ distribution partnerships 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 initial commercialization and marketing activities for its Wellness
products, and product development (research, clinical trials, regulatory tasks) costs for its emerging products, Breath
PulmoHealth “Check” rapid assays and PIFA PLUSS® Infectious Disease point-of-care tests); 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 December 31, 2015, Akers had cash of $402,059, working capital of $4,812,337, stockholders’ equity of $6,603,178 and an
accumulated deficit of $94,175,999. The Company believes that its current working capital position will be sufficient to meet its
estimated cash needs for at least the next twelve months
The fair value of the Company’s investments in marketable securities as of December 31, 2015 was $4,025,104 (2014: $9,264,961).
The Company restricts its investments to Level I and Level II securities and maturities generally range up to three years. Securities are
evaluated with an emphasis on minimizing risk while achieving reasonable rates of return on the investment. These marketable
securities are a key component of the Company’s cash management strategy and as such are monitored regularly.
If the Company does not obtain additional capital as needed, the Company would potentially be required to reduce the scope of its
research and development activities. The Company is closely monitoring its cash balances, cash needs and expense levels.
Revenue
The Company’s total revenue for the year ended December 31, 2015 was $2,115,050, a 52% decrease compared to the same period in
2014. The table below presents a summary of our sales by product line:
Product Line
Year Ended
Year Ended
December 31, 2015
December 31, 2014
Percent
Change
MicroParticle Catalyzed Biosensor (“MPC”)
$
296,328 $
918,049
Particle ImmunoFiltration Assay (“PIFA”)
Rapid Enzymatic Assay (“REA”)
Other
Product Revenue Total
License Fees
Total Revenue
$
$
1,391,017
-
107,149
1,794,494 $
320,556
2,115,050 $
2,241,406
864,000
60,386
4,083,841
343,333
4,427,174
-68 %
-38 %
-100 %
77 %
-56 %
-7 %
-52 %
This decline in product revenue is associated with three significance transactions that occurred during the year ended December 31,
2014, which were not repeated in 2015. These transactions (ChubeWorkx (MPC: $766,379), NovoTek (PIFA: $1,000,000) and 36S
(REA: $864,000)) are further described below.
The Company’s MPC product sales declined during the year ended December 31, 2015. This reflects that during the same period of
2014, the Company received its last order from ChubeWorkx ($766,379) for the Company’s alcohol breathalyzer product. Three new
distributors began placing orders for the alcohol breathalyzer products during the year, two in the European Union (“EU”) and one in
South Africa which generated revenue of $189,889 for the year ended December 31, 2015.
43
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The Company’s total PIFA sales declined during the year ended December 31, 2015; however, the domestic sales of the PIFA
Heparin/PF4 Rapid Assay products increased by 12% to $1,391,017 (2014: $1,241,406). The Company’s dedicated technical sales
account executives are supporting over 300 sales representatives of Akers’ US distribution partners, Cardinal Health (“Cardinal
Health”), Fisher HealthCare (“Fisher Healthcare”), Typenex Medical, LLC (“Typenex”) and Medline Industries, Inc. (“Medline”).
The Company’s relationship-building initiative with our partners has already delivered a measureable increase in product trials and
adoptions. Domestic sales for the year ended December 31, 2015 of our distributors, Cardinal Health and Fisher Health, accounted for
$1,161,199 of the total PIFA Heparin/PF4 Rapid Assay as compared to $1,064,733 for the same period of 2014 and individually
represented 55% and 28% of such sales.
The Company did not generate any international sales of its PIFA Heparin/PF4 Rapid Assay products during the year ended December
31, 2015 (2014: $1,000,000) primarily the result of pending regulatory approvals. The recent approval of the product in China is
expected to stimulate minimum purchase requirements with our distributor, NovaTek Therapeutics Inc. (“NovaTek”) beginning in
2016.
There were no sales in the year ended December 31, 2015 for the Tri-Cholesterol “Check” tests, part of the REA line of products,
which generated sales of $864,000 during the same period of 2014. The revenue generated in the 2014 sale of the Tri-Cholesterol
“Check” tests was due to an initial stocking order from 36 Strategies General Trading, LLC, a related party, to distribute the tests in
Australia, Singapore, the United Arab Emirates and Oman (See Note 5 - Trade Receivables - Related Party).
Other operating revenue increased due to a rise in shipping and handling fees, a result of the mix of domestic and international
shipments and an increase in sales of miscellaneous components.
The Company’s exclusive License and Supply Agreement with ChubeWorkx Guernsey Limited (“ChubeWorkx”) for the Company’s
proprietary breathalyzer product was cancelled by both parties on May 7, 2015. As a result of this event, and per the terms of the
original agreement, the Company recognized the remaining $166,667 of deferred revenue in the statement of operations and
comprehensive income for the year ended December 31, 2015. The Company is now able to solicit business outside the United States
for its alcohol breathalyzer products and has begun to receive and ship orders.
Licensing fee revenue declined to $320,556 (2014: $343,333). The decline is associated with the cancellation of the Company’s
exclusive License and Supply Agreement with ChubeWorkx as described above.
Cost of sales for the year ended December 31, 2015 decreased by 19% to $950,792 (2014: $1,175,232). The reduction is primarily
reflective of the decrease in revenue during the year ended December 31, 2015. Direct cost of sales increased to 29% (2014: 18%) and
indirect cost of sales increased to 24% (2014: 11%) of product revenue for year ended December 31, 2015. Overall, cost of sales, as a
percentage of product revenue, was 53% and 29% for the years ended December 31, 2015 and 2014.
Prior to 2014, the Company had removed its REA products from its active inventory while the Company worked to develop a market
and identify a distributor for the product line. As a result of this inventory write-down, there was no significant cost of sales for the
REA products reported for the year ended December 31, 2014. Direct costs associated with the MPC products decreased to 30%
(2014: 44%) primarily related to the mix of products sold and PIFA products decreased to 11% (2014: 15%) related to the increased
use of sub-contractors for the assembly of components.
The increase in indirect cost of sales is attributed to an ongoing project to improve the management, reporting and turn-over rate of
our production inventory which was completed during the fourth quarter, significantly higher shipping costs associated with an
increase in international shipments and an increase in the cost of consumable supplies related to production. In addition, the
percentage increase is affected by the fixed cost nature of many of the components in this category.
44
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
$
$
Akers’ gross profit margin, as a percentage of revenue, decreased to 55% for the year ended December 31, 2015 as compared to 73%
in 2014 for the reasons described above.
General and Administrative Expenses
General and administrative expenses in the year ended December 31, 2015 totaled $6,193,125, which was a 56% increase as compared
to $3,979,079 for the year ended December 31, 2014. The table below summarizes our general and administrative expenses for the
years ended December 31, 2015 and 2014 as well as the percentage of change year-over-year:
Description
Personnel Costs
Professional Service Costs
Stock Market & Investor Relations Costs
Other General and Administrative Costs
Total General and Administrative Costs
Year Ended
Year Ended
December 31, 2014
Percent
Change
December 31, 2015
$
902,431 $
1,233,126
572,161
3,485,407
6,193,125 $
834,750
1,038,508
650,559
1,455,262
3,979,079
8 %
19 %
-12 %
140 %
56 %
Several specific categories of expense increased significantly during the year ended December 31, 2015. Below is a summary of these
categories:
Description
Bad Debts Costs - Related parties
Employment Agency Costs
Legal Costs
Travel Costs
Total
Year Ended
Year Ended
December 31, 2014
Percent
Change
December 31, 2015
$
2,163,609 $
237,553
736,745
268,201
3,406,108 $
-
69,968
492,132
124,611
686,711
-
240 %
50 %
115 %
396 %
Professional services included significant increases in recruiting services and legal fees during the year ended December 31, 2015. The
increase in recruiting fees are related to the expansion of the sales and marketing staff and the recruitment of the Company’s Chief
Executive Officer. The increase in legal fees are associated with various corporate and legal affairs. Offsetting the professional service
expenses was the elimination of management fees paid to Nicolette Consulting Group for services that were incurred in the year ended
December 31, 2014.
The Company recognized cost savings in all of its stock market and investor relations categories. These include consulting, investor
relations, stock exchange fees and transfer agent fees.
The Company established an allowance for doubtful accounts of $864,000 for a trade receivable - related party that was due June 30,
2015 after receiving communications from the customer that indicated a high level of risk of collectability. In addition, the Company
also established an allowance for doubtful accounts for $1,299,609 for a note receivable - related party as a result of an internal
assessment indicating a high level of risk of collectability. These allowances are reflected in the other general and administrative
expenses in the table above for the year ended December 31, 2015.
45
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Sales and Marketing Expenses
Sales and marketing expenses in the year ended December 31, 2015 totaled $2,543,286, which was a 95% increase as compared to
$1,302,103 for the year ended 2014. The table below summarizes our sales and marketing expenses for the years ended December 31,
2015 and 2014 as well as the percentage of change year-over-year:
Description
Personnel Costs
Professional Service Costs
Royalties and Commission Costs
Other Sales and Marketing Costs
Total Sales and Marketing Costs
Year Ended
Year Ended
December 31, 2014
Percent
Change
December 31, 2015
$
1,359,460 $
751,220
158,347
274,259
2,543,286 $
503,401
550,515
129,780
118,407
1,302,103
170 %
36 %
22 %
132 %
95 %
$
Personnel costs increased in the year ended December 31, 2015 due to the expansion of the sales and marketing department from 5
employees at December 31, 2014 to 10 employees as of December 31, 2015.
The increase in professional service costs is for international sales consultants and domestic marketing consultants to assist in the
development of new market opportunities and to increase our market penetration in our existing markets; and web designers to assist
with the design and implementation of a new internet presence.
Travel expenses are a result of the increased size of the sales force and make up the most significant component of the other sales and
marketing costs.
Research and Development
Research and development expenses in the year ended December 31, 2015 totaled $1,406,895, which was a 54% increase as compared
to $916,308 for the year ended 2014. The table below summarizes our research and development expenses for the years ended
December 31, 2015 and 2014 as well as the percentage of change year-over-year:
Description
Personnel Costs
Professional Service Costs
Clinical Trial Costs
Other Research and Development Costs
Total Research and Development Costs
Year Ended
Year Ended
December 31, 2014
Percent
Change
December 31, 2015
$
699,595 $
504,800
41,586
160,914
1,406,895 $
706,230
85,703
10,500
113,875
916,308
-1 %
489 %
296 %
41 %
54 %
$
Clinical trial costs, professional service costs and other research and development costs have increased in the year ended December
31, 2015 due to the significant costs associated with preparing several key products for market. Major expenses include engineering
fees related to the development of molds for new products, development of the BreathScan Lync and associated apps for tablets and
smartphones, new packaging design, testing and clinical trials.
46
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The following table illustrates research and development costs by project for the years ended December 31, 2015 and 2014,
respectively.
Asthma/pH
Beath Alochol Phone Application
BreathScan
Chlamydia Trachomatis
CHUBE
H/PF4
HIV
Ketone/Metron
KetoChek / OxiChek
Lithium
Lyophilization
Malaria
Metron
Other Projects
PF4 PLUSS
Pulmo Health
Sonicator OQ
Troponin
Tri Cholesterol
VIVO
Total R&D Expenses:
Other Income and Expense
2015
2014
$
$
4,917 $
-
110,609
134,362
397
98,876
150,543
72,757
252,462
41,086
-
-
77,796
156,379
-
18,283
886
127,095
96,271
64,176
1,406,895 $
5,359
10,540
13,866
143,312
3,867
107,875
56,586
48,305
-
-
74,956
6,810
4,904
46,138
36,960
-
-
53,965
125,553
182,215
916,308
Other income and expense increased for the year ended December 31, 2015 to $370,317 from $61,161 for the same period in 2014.
The table below summarizes our other income and expenses for the years ended December 31, 2015 and 2014 as well as the
percentage of change year-over-year:
Year Ended
Year Ended
December 31, 2014
December 31, 2015
$
Description
Currency Translation (Gain)/Loss
Dividend on Series A Preferred Stock
Investment (Gain)/Loss
Interest and Dividends
Sale of New Jersey Net Operating Loss
Other Extraordinary Income
Total Other (Income) and Expense
$
7,535 $
-
6,512
(108,968 )
(269,344 )
(6,052 )
(370,317 ) $
Percent
Change
-383 %
-100 %
-967 %
58 %
-
30 %
505 %
(2,667 )
15,793
(751 )
(68,867 )
-
(4,669 )
(61,161 )
The increase is the result of interest and dividend earning on the marketable securities and note receivable - related party and the sale
of the Company’s New Jersey Net Operating Losses.
Income Taxes
During 2015, the Company was approved by the State of New Jersey to sell a portion of its state tax benefits that existed as of
December 31, 2014, pursuant to the Technology Tax Certificate Transfer Program. The Company received net proceeds of $269,344
for the year ended December 31, 2015 (2014: $-) as a result of the sale of the tax benefits
As of December 31, 2015 and 2014, the Company had Federal net operating loss carry forwards of approximately $58,000,000 and
$51,300,000, respectively, expiring through the year ending December 31, 2034. As of December 31, 2015 and 2014, the Company
had New Jersey state net operating loss carry forwards of approximately $7,200,000 and $11,900,000, respectively, expiring the year
ending December 31, 2021.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
47
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The principal components of deferred tax assets and valuation allowance as of December 31, 2014 and December 31, 2013 are as
follows:
Deferred Tax Assets
Reserves and other
Net operating loss carry-forwards
Valuation Allowance
Net
Year Ended December 31,
2014
2015
$
$
$
$
2,506,000 $
20,728,000 $
(23,234,000 ) $
- $
684,830
18,754,066
(19,438,896 )
-
The valuation allowance for deferred tax assets as of December 31, 2015 and 2014 was $23,234,000 and $19,438,896. The change in
the total valuation for the years ended December 31, 2015 and 2014 were increases of $3,795,104 and $1,428,358. In assessing the
realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred tax
assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income
during the periods in which the net operating losses and temporary differences become deductible. Management considered projected
future taxable income and tax planning strategies in making this assessment. The value of the deferred tax assets was fully offset by a
valuation allowance, due to the current uncertainty of the future realization of the deferred tax assets.
The reconciliation of income taxes using the statutory U.S. income tax rate and the benefit from income taxes for the years ended
December 31, 2015 and December 31, 2014 are as follows.
Tax Rates & Benefits
Statutory U.S. Federal Income Tax Rate
New Jersey State income taxes, net of U.S.
Federal tax effect
Benefit from sale of New Jersey NOL
Change in Valuation Allowance
Net
Liquidity and Capital Resources
Year Ended December 31,
2014
2015
(35.0 )%
(35.0 )%
(6.0 )%
(2.9 )%
41.0 %
(2.9 )%
(5.9 )%
0.0 %
40.9 %
0.00 %
For the years ended December 31, 2015 and 2014, the Company generated a net loss attributable to shareholders of $9,311,913 and
$3,142,960, respectively. As of December 31, 2015 and 2014, the Company has an accumulated deficit of $94,175,999 and
$84,864,086 and had cash and cash equivalents totaling $402,059 and $455,841, respectively (although the Company had additional
marketable securities of $4,025,104 and $9,264,961 available as of December 31, 2015 and 2014).
Currently, our primary focus is to expand the domestic and international distribution of our PIFA Heparin/PF4 rapid assays. The
Company continues initial commercialization tasks for METRON and BreathScan Lync, as well as development activities for its PIFA
PLUSS® Infectious Disease single-use assays, Breath Ketone “Check”, and Breath PulmoHealth “Check” products, including
advancement of the steps required for FDA clearance or CE marking in the EU where necessary.
48
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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 believe that our current working capital position will be sufficient to meet our estimated cash needs until it reaches a
cash flow positive position. 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 PIFA PLUSS® Infectious Disease single-use assays,
Breath Ketone “Check” and Breath PulmoHealth “Check” products and enroll patients in clinical trials to support performance claims,
generate studies in peer-reviewed journals to support product marketing, and provide data for the FDA 510(k) clearance/CE
certifications processes when required. We will also continue to support commercialization and marketing activities of in-line
products (PIFA Heparin/PF4 rapid assays, PIFA PLUSS® PF4, breath alcohol detectors, METRON and BreathScan Lync) in the U.S.
and internationally. 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, primarily for production, laboratory and facility improvement costs for the year ending December 31, 2015 are
approximately $112,951 (2014: $24,988). As per the Company’s lease agreement, the owner of the facility will be handling the
majority of 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. 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 current 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 current environment and their impact on the Company’s results.
Operating Activities
The Company’s net cash consumed by operating activities in the year ended December 31, 2015 totaled $5,132,343, which was a 32%
increase as compared to $3,883,929 for the year ended 2014. The table below summarizes our net cash consumed for the years ended
December 31, 2015 and 2014 as well as the percentage of change year-over-year:
Description
Loss from Operations
Adjustments
Non-Operating Gains
Non-Cash Activities
Cash Used in Operating Activities
Cash Consumed by Operating Activities
Cash Contributed by Operating Activities
Net Cash Used in Operating Activities
Year Ended
Year Ended
December 31, 2015
$
(9,311,913 ) $
December 31, 2014
(6,052 )
3,331,291
(663,010 )
1,517,341
(5,132,343 ) $
$
49
Percent
Change
198 %
-77 %
204 %
-74 %
112 %
32 %
(3,127,167 )
(26,203 )
1,095,798
(2,543,680 )
717,323
(3,883,929 )
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
For the year ended December 31, 2015, cash was consumed by the loss of $9,311,913 less non-operating gains of $6,052 plus a
non-cash adjustment of $4,199 for accrued interest and dividends, $766,471 for depreciation, amortization and impairment of
non-current assets, $2,163,609 for allowances for doubtful accounts and $397,012 for non-cash share based compensation and
services. Decreases in trade receivables ($513,583), trade receivables - related party ($176,157) and an increase in trade and other
payables ($827,601) provided cash. Increases in other receivables ($54,142), inventories ($226,538), other assets ($76,774) and a
decrease in deferred revenue - related party ($305,556) consumed cash. The increase in net cash used in operating activities was
related to routine changes in operating activities.
For the year ended December 31, 2014, cash was consumed by the loss of $3,127,167 less non-operating gains of $26,203 plus a
non-cash adjustment of $349,398 for depreciation and amortization of non-current assets and $746,400 for non-cash share based
compensation and services. Decreases in inventories ($123,049), other assets ($56,257) and an increase in trade and other payables
($538,017) provided cash. Increases in trade receivables ($1,899,886), notes receivable - related party ($266,378) and other
receivables ($37,497) and a decreases other payables - related party ($6,586) and in deferred revenue - related party ($333,333)
consumed cash. The increase in net cash used in operating activities was related to routine changes in operating activities.
Critical Accounting Policies
We intend to utilize the extended transition period provided in Securities Act Section 7(a)(2)(B) as allowed by Section 107(b)(1) of
the JOBS Act for the adoption of new or revised accounting standards as applicable to emerging growth companies. Under the JOBS
Act, emerging growth companies may delay adopting new or revised accounting standards that have different effective dates for
public and private companies until such time as those standards apply to private companies. We have elected to use the extended
transition period for complying with these new or revised accounting standards. Since we will not be required to comply with new or
revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies, our
financial statements may not be comparable to the financial statements of companies that comply with public company effective dates.
If we were to elect to comply with these public company effective dates, such election would be irrevocable pursuant to Section 107
of the JOBS Act.
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America
(US GAAP) requires management to make estimates and assumptions about future events that affect the amounts reported in the
financial statements and accompanying notes. Future events and their effects cannot be determined with absolute certainty. Therefore,
the determination of estimates requires the exercise of judgment. Actual results inevitably will differ from those estimates, and such
differences may be material to the financial statements. The most significant accounting estimates inherent in the preparation of our
financial statements include estimates associated with revenue recognition, impairment analysis of intangibles and stock-based
compensation.
The Company’s financial position, results of operations and cash flows are impacted by the accounting policies the Company has
adopted. In order to get a full understanding of the Company’s financial statements, one must have a clear understanding of the
accounting policies employed. A summary of the Company’s critical accounting policies follows:
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.
50
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The normal credit terms extended to customers ranges between 30 and 90 days. 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.
Fair Value Measurement - Marketable Securities:
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
1
Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities 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
3
Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
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.
Intangible Assets:
Intangible assets primarily represent legal and filing costs associated with obtaining patents on the Company’s new discoveries or
acquiring patents for diagnostic technologies or tests that will enhance the Company’s product portfolio. The Company has developed
or acquired several diagnostic tests that can detect the presence of various substances in a person’s breath, blood, urine and saliva.
Propriety protection for the Company’s products, technology and process is important to its competitive position. To date, the
Company has nine patents from the United States Patent Office in effect (8,871,521, 8,808,639, 7,896,167, 8,097,171, 8,003,061,
8,425,859, 5,565,366, 5,827,749, D691,056, D691,057 and D691,058). Other patents are in effect in Australia through the Design
Registry (348,310, 348,311 and 348,312), the Community Trade Mark in the European Union ((OHIM) 002216895-0001,
002216895-0002 and 002216895-0003) and in Japan (4,885,134 and 4,931,821). Patents are in the national phase of prosecution in
many PCT participating countries. Additional proprietary technology consists of numerous different inventions. The Company intends
to file additional patent applications, where appropriate, relating to new products, technologies and their use in the U.S., European and
Asian markets. Management intends to protect all other intellectual property (e.g. copyrights, trademarks and trade secrets) using all
legal remedies available to the Company.
51
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Costs associated with applying for patents are capitalized as patent costs. Once the patents are approved, the respective costs are
amortized over a period of twelve to seventeen years on a straight-line basis. Patent pending costs for patents that are not approved are
charged to operations the year the patent is rejected.
In addition, patents may be purchased from third parties. The costs of acquiring the patent are capitalized as patent costs if it
represents a future economic benefit to the Company. Once a patent is acquired it is amortized over its remaining life. The Company
amortizes these costs over the shorter of the legal life of the patent or its estimated economic life using the straight-line method. The
Company tests intangible assets with finite lives upon significant changes in the Company’s business environment.
The testing resulted in no patent impairment charges during the years ended December 31, 2015 and 2014 respectively.
Long-Lived Assets:
Recognition and measurement
Items of property, plant and equipment are measured at cost less accumulated depreciation and accumulated impairment losses. Cost
includes expenditure that is directly attributable to the acquisition of the asset. When parts of an item of property, plant and equipment
have different useful lives, they are accounted for as separate items (major components) of property, plant and equipment. 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 net within “other income” in profit or loss.
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.
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.
Stock-based Compensation
FASB ASC 718, Share-Based Payment, defines the fair-value-based method of accounting for stock-based employee compensation
plans and transactions used by the Company to account for its issuances of equity instruments to record compensation cost for
stock-based employee compensation plans at fair value as well as to acquire goods or services from non-employees. Transactions in
which the Company issues stock-based compensation to employees, directors and consultants and for goods or services received from
non-employees are accounted for based on the fair value of the equity instruments issued. The Company utilizes pricing models in
determining the fair values of options and warrants issued as stock-based compensation. The Black-Scholes model is utilized to
calculate the fair value of equity instruments.
52
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Recently Issued and Adopted Accounting Pronouncements
The Company has evaluated all recently issued and adopted accounting pronouncements and believes such pronouncements do not
have a material effect on the Company’s financial statements.
Quantitative and Qualitative Disclosure About Market Risk
We have limited exposure to market risks from instruments that may impact the Balance Sheets, Statements of Operations, and
Statements of Cash Flows. Such exposure is due primarily to changing interest rates.
The primary objective for our investment activities is to preserve principal while maximizing yields without significantly increasing
risk. This is accomplished by investing excess cash in highly liquid debt and equity investments of highly rated entities which are
classified as trading securities.
Off-Balance Sheet Arrangements
We have no significant known off balance sheet arrangements.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk.
We do not hold any derivative instruments and do not engage in any hedging activities.
Item 8. Financial Statements and Supplementary Data.
Our financial statements are contained in pages F-1 through F-27 which appear at the end of this Annual Report.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
There have been no changes in or disagreements with accountants on accounting and financial disclosure.
Item 9A. Controls and Procedures.
(a) Evaluation of Disclosure and Control Procedures
The Company maintains “disclosure controls and procedures”, as such terms are defined under Exchange Act Rule 13a-15(e), that are
designed to ensure that information required to be disclosed in our Exchange Act reports is 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 our management, including our Chief Executive Officer and Principal Accounting Officer, as appropriate, to allow timely decisions
regarding required disclosures. The Company acknowledges that any controls and procedures can provide only reasonable assurances
of achieving the desired control objectives.
We have carried out an evaluation as required by Rule 13a-15(d) under the supervision of and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of
our disclosure controls and procedure as of December 31, 2015. Based upon their evaluation, the Chief Executive Officer and
Principal Accounting Officer concluded that, as of December 31, 2015, the Company’s disclosure controls and procedures were not
effective. Although we have determined that the existing controls and procedures are not effective, the deficiencies identified have not
been deemed material to our reporting disclosures.
We engaged an independent accounting firm to assist with updating our controls and procedures during the year ended December 31,
2015, as the Company previously utilized the International Financial Reporting Standards (“IFRS”). With their assistance, we are
actively implementing their recommendations to improve our controls and procedures for disclosures.
53
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
(b) Management’s Report on Internal Controls over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting, as such
term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f). Internal control over financial reporting refers to the process designed
by, or under the supervision of, our principal executive officer and principal financial officer, and effected by our Board of Directors,
management and other personnel, 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.
Internal control over financial reporting cannot provide absolute assurance of achieving their objectives. Internal control over financial
reporting is a process that involves human diligence and compliance and is subject to lapses in judgement and breakdowns resulting
from human failures. Due to their inherent limitations, there is a risk that material misstatements may not be prevented or detected on
a timely basis by internal control over financial reporting. It is possible to design safeguards to reduce, but not eliminate, this risk.
Management is responsible for establishing and maintaining adequate internal control over financial reporting for the Company.
During the year ended December 31, 2015, the Company engaged an independent accounting firm to assist with the evaluation of the
effectiveness of our internal controls over financial reporting. Management has used the framework set forth in the report entitled
Internal Control-Integrated Framework published by the Committee of Sponsoring Organizations of the Treadway Commission (2013
framework), known as COSO, to evaluate the effectiveness of our internal control over financial reporting.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a
reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or
detected on a timely basis. Based on such evaluation, our CEO and CFO have concluded that, as of December 31, 2015, our internal
controls over financial reporting were not effective.
As a result of our evaluation, we identified a material weakness in our controls related to segregation of duties and other non-material
weaknesses in several areas of data management and documentation.
The Company’s management is composed of a small number of professionals resulting in a situation where limitations on segregation
of duties exists. Accordingly, as a result of the material weakness identified above, we have concluded that the control deficiencies
result in a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented on a
timely basis by the Company’s internal controls.
While the material weakness set forth above were the result of the scale of our operations and are intrinsic to our small size, the
Company believes the risk of material misstatements relative to financial reporting are minimal.
This annual report does not include an attestation report of our registered public accounting firm regarding internal control over
financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to the
Dodd-Frank Wall Street Reform and Consumer Protection Act, which permits us to provide only management’s report in this annual
report.
(c) Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the
Exchange Act, during our most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Item 9B. Other Information.
None.
54
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Item 10. Directors, Executive Officers, and Corporate Governance.
Executive Officers and Directors
PART III
The following table sets forth the names, ages and positions of all of the directors and executive officers of the Company and the
positions they hold as of the date hereof. The directors of the Company serve until their successors are elected and shall qualify.
Executive officers are elected by the Board of Directors and serve at the discretion of the directors.
Name
Raymond F. Akers, Jr. PhD
John J. Gormally
Gary M. Rauch
Tom Knox
Brandon Knox
Robert E. Andrews
Dr. Raza Bokhari
Age
57
59
60
74
36
58
48
Position
Executive Chairman of the Board of Directors, Secretary
Chief Executive Officer
Vice President of Finance, Treasurer
Independent Director
Independent Director
Independent Director
Independent Director
Set forth below is a brief description of the background and business experience of each of our executive officers and directors.
John J. Gormally, age 59
Mr. Gormally, age 59, has over 30 years of experience as senior management in the healthcare industry. Mr. Gormally joined Becton,
Dickinson and Company (“Becton”), a medical technology company that manufactures and sells a range of medical supplies and
diagnostic equipment, in 1978 as a senior sales representative. Mr. Gormally served in a wide range of positions with Becton through
2013, focusing primarily on commercialization of Becton’s products and fostering sales growth. From 1999 to 2001, Mr. Gormally
served as the Vice President of U.S. Sales and Operations for ConvaTec, a former division of Bristol-Myers Squibb Company. From
2001 to 2002, he served as the Vice President of Global Sales and Marketing for BEI Medical Systems Company, Inc., prior to
rejoining Becton from 2002 to 2013. In 2013, Mr. Gormally founded Gormally Elite Medical LLC, a healthcare consulting firm that
specializes human resources and developing go-to-market commercialization strategies.
Mr. Gormally earned an undergraduate degree from DeSales University in 1978 and is currently pursuing an MBA from Northeastern
University.
In evaluating Mr. Gormally’s experience, qualifications, attributes and skills in connection with his appointment to the Board, the
Company took into account his extensive experience in the healthcare and medical diagnostic industries.
55
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Raymond F. Akers Jr., Ph.D., age 57, has been Executive Chairman of the Board since December 31, 2009 and was appointed
Secretary on August 5, 2013. Dr. Akers founded the Company in 1989. He has over 25 years of experience in the diagnostics industry
having co-founded Drug Screening Systems, Inc., a publicly listed company, in 1987, and Akers Medical Technology Inc. in 1984. He
was Chief Executive Officer and vice president of research and development of Drug Screening Systems, Inc. until the sale of that
company in 1989 and served as President and Chief Executive Officer of Akers Medical Technology Inc. until 1987.
Dr. Akers holds a Ph.D. in Neurochemistry from Northwestern University. Dr. Akers has either invented or directed the research and
development of all of the Company’s products and technologies.
The Company believes that Mr. Akers’ experience in assisting diagnostic companies develop infrastructure; including but not limited
to general management, product and technology development, and business development will contribute to the Company’s
development of its own infrastructure and growth as a public company.
Gary M. Rauch, age 60, has over 35 years of experience in accounting, financial and information systems consulting, discrete
manufacturing, distribution and administration. Mr. Rauch was appointed the Vice President of Finance and became an employee of
the Company effective February 2, 2014. Prior to this time, Mr. Rauch was the Company’s controller from March, 2010 through
February 2, 2014. Additionally, Mr. Rauch has served as the Company’s treasurer from August 5, 2013 through the present. Mr.
Rauch also founded DataSys Solutions, LLC in 2004 and is currently the managing member. DataSys Solutions LLC specializes in
financial and information systems consulting and technical support services. From July, 2002 through March, 2010, Mr. Rauch was
the controller for Cold Star, Inc., a manufacturer of dairy dispensing equipment and a dairy products distributor. Mr. Rauch also
worked for six years as consulting manager with Deloitte & Touche providing financial system selection, development and
implementation services for their small to middle market clients.
Mr. Rauch has an associate degree from the University of South Carolina.
Thomas J. Knox, age 74, was appointed to our board of directors effective July 1, 2013 and was appointed as Co-Chairman on
August 11, 2014. Mr. Knox is currently the Chief Executive Officer of Knox Consulting Group, an advisory and investment firm, as
well as Chairman of ORB Automotive Corporation, Ltd. (appointed in 2011), a company focused on the development and
manufacture of various components used in the Chinese automotive industry including adhesives and rubber molds. In May of 2007,
Mr. Knox was a candidate for Mayor of Philadelphia. From April 2004 to April 2006, Mr. Knox was the Chief Executive Officer of
United Healthcare of Pennsylvania, a division of United Healthcare, Inc., the largest health insurance provider in the world. From
1999 to 2004, Mr. Knox was Chairman of the Board and Chief Executive Officer of Fidelity Insurance Group, Inc., a Maryland and
Pennsylvania licensed group life and health insurance provider. From 1988 through June 2000, Mr. Knox was the Chairman of the
board and Chief Executive Officer of Crusader Holding Corporation, a NASDAQ listed company which was the owner of a
multi-branch bank serving the greater Philadelphia area. Mr. Knox is a Chartered Life Underwriter (CLU) and Chartered Financial
Consultant (ChFC), and is active in Philadelphia politics having held the position of Deputy Mayor for the Office of Management and
Productivity from 1993 to 1999. Mr Knox also currently serves as the Chairman of INDECS Corp, a full service health benefit third
party administrator affiliated with Aetna Corporation. From 1999 through the present, Mr. Knox has been a director of Historic
Philadelphia Incorporated. Mr. Knox was a candidate for Governor or Pennsylvania from 2008 to 2010.
The Company believes that Mr. Knox extensive expertise in health care and finance will assist the Company’s strategic planning and
operations.
Brandon Knox, age 36, Mr. Knox has been a wealth advisor at Raymond James in Philadelphia since December 2012. His practice
focuses on investment and estate solutions for high net worth families and individuals as well as public and private institutions both
locally and nationally. Prior to joining Raymond James, Mr. Knox was a wealth advisor at Morgan Stanley from July 2008 to October
2012. From 2006 to 2008, Mr. Knox served as Deputy Finance Director for the Philadelphia mayoral campaign of his Father, Thomas
Knox. In this role he concentrated on the organization and management of campaign fundraising efforts as well as the planning and
execution of campaign events and off-site functions. Mr. Knox was a Leasing Associate for SSH Realty in Philadelphia from 2005 to
2007 handling lease negotiations for both commercial tenants and landlords. Mr. Knox holds a BS in Economics from West Chester
University and an MBA in Financial Management from Drexel University. Mr. Knox sits on the Board of Directors of The Committee
of Seventy and is a member of the Drexel University Presidents Leadership Council and the Archdiocese of Philadelphia’s OSD
Advisory Council.
56
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Mr. Knox holds a B.S. in Economics from West Chester University and an M.B.A. in Financial Management from Drexel
University’s LeBow College of Business.
The Company believes that Mr. Knox vast experience with corporate finance and financial management will make him an ideal board
member helping the Company to manage its finances as it continues its growth.
Robert E. Andrews, age 58
Robert E. Andrews has over 20 years of experience in public service serving in a variety of capacities. From March 2014 through the
present, after nearly 24 years of public service, Mr. Andrews joined Dilworth Paxson LLC to lead its Government Affairs. Mr.
Andrews first became a member of the Camden County Board of Chosen Freeholders from 1986 to 1990, including two years as
freeholder director (1988-1990). Following this, he was elected to the U.S. House of Representatives for New Jersey’s 1st
congressional district in 1990. He served in this position until 2014. While serving as a representative, Mr. Andrews was nominated as
the Co-Chairman of the Democratic Steering and Policy Committee by Leader Pelosi and held this position from 2012 until 2014. He
was also a ranking member of the Subcommittee on Health, Employment, Labor and Pensions and served as chairmen from 2007 to
2010. Mr. Andrews was also a member of the House Armed Services Committee and became chairman of a Special Panel on
Procurement Reform in 2009 and served until 2010. He became a ranking member of Special Panel on Pentagon Audit in 2011 and
served until 2012. Mr. Andrews also served as a member of the Education and the Workforce Committee from 1990 to 2014, a
member of the House Budget Committee from 2007 to 2011, a member of the House Foreign Affairs Committee from 1993 to 1998,
and a member of the House Small Business Committee from 1990 to 1992.
Mr. Andrews has an undergraduate degree from Bucknell University and a juris doctorate from Cornell Law School.
In evaluating Mr. Andrews’ experience, qualifications, attributes and skills in connection with his appointment to the Board, the
Company took into account his experience in government and the healthcare industry.
Dr. Raza Bokhari, age 48
Dr. Raza Bokhari, age 48, has over 24 years of experience in healthcare senior management. Previously, he has been involved in five
companies, also in the healthcare sector, holding positions including Chairman, Chief Executive Officer (CEO), President and Chief
Development Officer (CDO). From Jan 2001 through May 2007, Dr. Bokhari was President and CEO of Lakewood Pathology
Associates Inc., a national provider of anatomic pathology and diagnostic services company. From April 2003 to May 2008, he was
the President and CEO of Parkway Clinical Laboratories (PCL), a national clinical reference laboratory with a focus on serving pain
management specialists, behavioral health providers, and anti-aging and wellness providers. Dr. Bokhari again joined PCL in May
2013 to present day and serves as the Chairman and CEO. From May 2008 to May 2009, Dr. Bokhari was the Chief Development
officer of Rosetta Genomics (ROSG) a publicly traded, microRNA-based diagnostic testing company. He also serves as Vice
Chairman of the World Affairs Council of Philadelphia and is a Trustee of the esteemed Foreign Policy Research Institute. He has
previously served as Trustee of Franklin Institute. Dr. Bokhari has a Doctor of Medicine degree from University of Punjab,
Rawalpindi Medical College, Pakistan and an Executive MBA from the Fox School of Business, Temple University in Philadelphia,
PA.
In evaluating Dr. Bokhari’s experience, qualifications, attributes and skills in connection with his appointment to the Board, the
Company took into account his extensive experience in the healthcare and medical diagnostic industries.
Family Relationships
Tom Knox and Brandon Knox are father and son, respectively. There are no other family relationships among any of our directors or
executive officers.
57
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Board Composition and Committees and Director Independence
Our board of directors consists of 5 members: Raymond F. Akers, Jr. PhD, Thomas Knox, Robert E. Andrews, Dr. Raz Bokhari and
Mr. Brandon Knox. The directors will serve until our next annual meeting and until their successors are duly elected and qualified.
The Company defines “independent” as that term is defined in Rule 5605(a)(2) of the NASDAQ listing standards.
In making the determination of whether a member of the board is independent, our board considers, among other things, transactions
and relationships between each director and his immediate family and the Company, including those reported under the caption
“Related Party Transactions”. The purpose of this review is to determine whether any such relationships or transactions are material
and, therefore, inconsistent with a determination that the directors are independent. On the basis of such review and its understanding
of such relationships and transactions, our board affirmatively determined that Mr. Thomas Knox, Mr. Robert E. Andrews, Dr. Raza
Bokhari and Mr. Brandon Knox are qualified as independent and that none of them have any material relationship with us that might
interfere with his or her exercise of independent judgment.
Board Committees
The Company has established an audit committee, a compensation committee and a nominating and corporate governance committee.
Each committee has its own charter, which is available on our website at www.akersbio.com. Information contained on our website
is not incorporated herein by reference.
Audit Committee
We have a separately-designated standing Audit Committee established in accordance with Section 3(a)(58)(A) of the Exchange Act
of 1934, as amended (the Exchange Act”). The members of our Audit Committee are Tom Knox, Robert E. Andrews and Brandon
Knox. Each of these Committee members is “independent” within the meaning of Rule 10A-3 under the Exchange Act and the
NASDAQ Stock Market Rules. Our board has determined that Tom Knox is an “audit committee financial expert”, as such term is
defined in Item 407(d)(5) of Regulation S-K. Tom Knox serves as Chairman of our Audit Committee.
The Audit Committee oversees our accounting and financial reporting processes and oversee the audit of our financial statements and
the effectiveness of our internal control over financial reporting. The specific functions of this Committee include, but are not limited
to:
●
●
●
●
●
●
●
●
●
selecting and recommending to our board of directors the appointment of an independent registered public accounting firm
and overseeing the engagement of such firm;
approving the fees to be paid to the independent registered public accounting firm;
helping to ensure the independence of the independent registered public accounting firm;
overseeing the integrity of our financial statements;
preparing an audit committee report as required by the SEC to be included in our annual proxy statement;
resolve any disagreements between management and the auditors regarding financial reporting;
reviewing with management and the independent auditors any correspondence with regulators and any published reports that
raise material issues regarding the Company’s accounting policies;
reviewing and approving all related party transactions; and
overseeing compliance with legal and regulatory requirements.
58
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Compensation Committee
The members of our Compensation Committee are Tom Knox, Robert E. Andrews and Brandon Knox. Each such member is
“independent” within the meaning of the NASDAQ Stock Market Rules. In addition, each member of our Compensation Committee
qualifies as a “non-employee director” under Rule 16b-3 of the Exchange Act. Our Compensation Committee assists the board of
directors in the discharge of its responsibilities relating to the compensation of the board of directors and our executive officers. Tom
Knox serves as Chairman of our Compensation Committee.
The Committee’s compensation-related responsibilities include, but are not limited to:
●
●
●
●
●
●
●
reviewing and approving on an annual basis the corporate goals and objectives with respect to compensation for our Chief
Executive Officer;
reviewing, approving and recommending to our board of directors on an annual basis the evaluation process and
compensation structure for our other executive officers;
determining the need for an the appropriateness of employment agreements and change in control agreements for each of our
executive officers and any other officers recommended by the Chief Executive Officer or board of directors;
providing oversight of management’s decisions concerning the performance and compensation of other company officers,
employees, consultants and advisors;
reviewing our incentive compensation and other equity-based plans and recommending changes in such plans to our board of
directors as needed, and exercising all the authority of our board of directors with respect to the administration of such plans;
reviewing and recommending to our board of directors the compensation of independent directors, including incentive and
equity-based compensation; and
selecting, retaining and terminating such compensation consultants, outside counsel or other advisors as it deems necessary
or appropriate.
Nominating and Corporate Governance Committee
The members of our Nominating and Corporate Governance Committee are Tom Knox, Robert E. Andrews and Brandon Knox. Each
such member is “independent” within the meaning of the NASDAQ Stock Market Rules. The purpose of the Nominating and
Corporate Governance Committee is to recommend to the board nominees for election as directors and persons to be elected to fill any
vacancies on the board, develop and recommend a set of corporate governance principles and oversee the performance of the board.
Mr. Robert E. Andrews serves as Chairman of our Nominating and Corporate Governance Committee.
The Committee’s responsibilities include:
●
●
●
●
●
recommending to the board of directors nominees for election as directors at any meeting of stockholders and nominees to
fill vacancies on the board;
considering candidates proposed by stockholders in accordance with the requirements in the Committee charter;
overseeing the administration of the Company’s Code of Ethics;
reviewing with the entire board of directors, on an annual basis, the requisite skills and criteria for board candidates and the
composition of the board as a whole;
the authority to retain search firms to assist in identifying board candidates, approve the terms of the search firm’s
engagement, and cause the Company to pay the engaged search firm’s engagement fee;
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
●
●
●
recommending to the board of directors on an annual basis the directors to be appointed to each committee of the board of
directors;
overseeing an annual self-evaluation of the board of directors and its committees to determine whether it and its committees
are functioning effectively; and
developing and recommending to the board a set of corporate governance guidelines applicable to the Company.
59
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The Nominating and Corporate Governance Committee may delegate any of its responsibilities to subcommittees as it deems
appropriate. The Nominating and Corporate Governance Committee is authorized to retain independent legal and other advisors, and
conduct or authorize investigations into any matter within the scope of its duties.
Management-Non-Executive Director Compensation
Mr. Thomas Knox was appointed to serve as non-executive director in 2013. Mr. Brandon Knox was appointed to serve as a
non-executive director in 2014. Mr. Robert E. Andrews and Dr. Raza Bokhari were appointed to serve as non-executive directors in
2015.
Currently, no director of the Company receives any cash compensation for their services as such, but in the future directors may
receive stock options pursuant to the Company’s stock option plan and grants of the Company’s common stock.
Legal Proceedings
To the best of our knowledge, during the past ten years, none of the following occurred with respect to our present or former director,
executive officer, or employee: (1) any bankruptcy petition filed by or against any business of which such person was a general
partner or executive officer either at the time of the bankruptcy or within two years prior to that time; (2) any conviction in a criminal
proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor offenses); (3) being subject
to any order, judgment or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction,
permanently or temporarily enjoining, barring, suspending or otherwise limiting his or her involvement in any type of business,
securities or banking activities; and (4) being found by a court of competent jurisdiction (in a civil action), the SEC or the
Commodities Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not
been reversed, suspended or vacated.
Compliance with Section 16(A) of the Exchange Act
Section 16(a) of the Exchange Act requires the Company’s directors, executive officers and persons who beneficially own 10% or
more of a class of securities registered under Section 12 of the Exchange Act to file reports of beneficial ownership and changes in
beneficial ownership with the SEC. Directors, executive officers and greater than 10% stockholders are required by the rules and
regulations of the SEC to furnish the Company with copies of all reports filed by them in compliance with Section 16(a).
Based solely on our review of certain reports filed with the Securities and Exchange Commission pursuant to Section 16(a) of the
Securities Exchange Act of 1934, as amended, the reports required to be filed with respect to transactions in our common stock during
the fiscal year ended December 31, 2014, were timely.
Code of Ethics and Business of Conduct
We have adopted a Code of Business Conduct and Ethics, which applies to our board of directors, our executive officers and our
employees, outlines the broad principles of ethical business conduct we adopted, covering subject areas such as:
●
●
compliance with applicable laws and regulations,
handling of books and records,
60
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
●
●
●
●
●
●
●
public disclosure reporting,
insider trading,
discrimination and harassment,
health and safety,
conflicts of interest,
competition and fair dealing, and
protection of company assets.
A copy of our Code of Business Conduct and Ethics is available without charge, to any person desiring a copy of the Code of Business
Conduct and Ethics, by written request to us at our principal offices at 201 Grove Road, Thorofare, New Jersey USA 08086.
Item 11. Executive Compensation.
The compensation provided to our “named executive officers” for 2015, 2014 and 2013 is set forth in detail in the Summary
Compensation Table and other tables and the accompanying footnotes and narrative that follow this section. This section explains our
executive compensation philosophy, objectives and design, our compensation-setting process, our executive compensation program
components and the decisions made for compensation in respect of 2015 for each of our named executive officers.
Our named executive officers who appear in the 2015 Summary Compensation Table are:
Raymond F. Akers, Jr., PhD
Executive Chairman, Secretary
John J. Gormally
Chief Executive Officer
Gary M. Rauch
Vice President of Finance, Treasurer
Summary Compensation Table
The following table summarizes information regarding the compensation awarded to, earned by or paid to, our Chief Executive
Officer, and our only other most highly compensated executive officers who earned in excess of $100,000 during 2015, 2014 and
2013.
Name and
Principal Position
Year
Salary
$
Cash
Bonus
Stock
Awards
Option
Awards
All
Other
$
$
$
$
Total
$
Raymond F Akers, Jr PhD
Executive Chairman(5)
Secretary
John J. Gormally (2)
Chief Executive Officer
President
Gary M Rauch
Vice President, Finance
Treasurer
2015
2014
2013
397,450
394,231
347,500
-
-
26,173
256,900
-
-
-
124,270
-
7,800 (1) 662,150
7,800 (1) 526,301
7,800 (1) 381,473
2015
24,038
-
-
-
650 (3)
24,688
2015
2014
2013
95,000
78,414
-
-
2,500
-
27,675
-
-
-
46,601
-
-
122,675
11,250 (4) 138,765
67,500
67,500 (4)
(1) Other Compensation for Dr. Akers consisted of a car allowance
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
(2) Mr. Gormally was appointed as Chief Executive Officer on December 2, 2015
(3) Other Compensation for Mr. Gormally consisted of a car allowance
(4)
Mr. Rauch became an employee of the Company effective February 2, 2014. Prior to this date, Mr. Rauch was paid a fee pursuant
to his consultant agreement. Fees paid to Mr. Rauch for his pre-employment period is recorded as other compensation.
(5) Dr. Akers gifted all stock and option awards to the Akers Family Trust, a trust to which he is not a named beneficiary.
61
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
STOCK AWARDS
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
(b)
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
(c)
Equity
Incentive Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options (#)
(d)
Option
Exercise
Price ($)
(e)
Option
Expiration
Date
(f)
Number
of
Shares
or Units
of Stock
That
Have
Not
Vested
(#)
(g)
(9)
Market
Value of
Shares
or Units
of Stock
That
Have
Not
Vested
($)
(h)
Equity
Incentive
Plan
Awards:
Number of
Unearned
Shares,
Units or
Other
Rights That
Have Not
Vested (#)
(i)
Equity
Incentive
Plan
Awards:
Market or
Payout
Value of
Unearned
Shares,
Units or
Other
Rights That
Have Not
Vested (#)
(j)
Name
(a)
Raymond F. Akers
Jr. Executive
Chairman
Gary Rauch VP of
Finance
Thomas Knox,
Co-Chairman
Robert E
AndrewsDirector
Brandon Knox,
Director
40,000 (1)
0
0
5.50 06/30/2019
0
0
0
15,000
0
0
5.50 06/30/2019
0
0
0
20,000
0
0
5.50 06/30/2019
0
0
0
0
0
0
0
n/a
0
0
0
0
0
0
0
0
0
Dr. Raza Bokhari
0
20,000
0
0
0
5.50 06/30/2019
0
0
0
0
n/a
0
0
0
0
(1) Dr. Akers gifted such options to the Akers Family Trust, a trust to which he is not a named beneficiary.
62
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
DIRECTOR COMPENSATION
The following sets forth the compensation awarded to, earned by, or paid to the named director by us during the year ended December
31, 2015.
Fees
earned or
paid in
cash
($)
Stock
Awards
($)
Option
Awards
($)
Non-
equity
incentive
plan
compensation
($)
All other
compensation
($)
0
0
0
0
0
0
0
128,450
269,600
196,100
59,174
39,462
0
0
0
0
0
0
0
0
0
0
0
0
Total
($)
0
128,450
269,600
196,100
59,174
39,462
0
0
0
0
0
0
Name
Raymond Akers, Jr.
Gavin Moran (1)
Tom Knox (2)
Brandon Knox (3)
Robert E. Andrews (4)
Dr. Raza Bokhari (5)
(1) Mr. Gavin Moran was not nominated for re-election as Director in 2015 and served in such capacity until August 3, 2015.
(2) Effective July 1, 2013, Mr. Tom Knox was appointed as Director.
(3) Effective January 23, 2014, Mr. Brandon Knox was appointed as Director.
(4) Effective June 29, 2015, Mr. Robert E. Andrews was appointed as Director.
(5) Effective November 11, 2015, Dr. Raza Bokhari was appointed as Director.
63
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table sets forth, as of March __, 2016, information regarding beneficial ownership of our capital stock by:
●
●
●
●
each person, or group of affiliated persons, known by us to beneficially own more than 5% of our common stock;
each of our named executive officers;
each of our directors; and
all of our current executive officers and directors as a group.
Beneficial ownership is determined according to the rules of the SEC and generally means that a person has beneficial ownership of a
security if he, she or it possesses sole or shared voting or investment power of the applicable security, including options that are
currently exercisable or exercisable within 60 days of March __, 2016. Except as indicated by the footnotes below, we believe, based
on the information furnished to us, that the persons named in the table below have sole voting and investment power with respect to all
shares of common stock shown that they beneficially own, subject to community property laws where applicable.
Our calculation of the percentage of beneficial ownership is based on 5,425,045 shares of our common stock issued and outstanding as
of March 25, 2016.
Common stock subject to stock options currently exercisable or exercisable within 60 days of March 25, 2016, are deemed to be
outstanding for computing the percentage ownership of the person holding these securities and the percentage ownership of any group
of which the holder is a member but are not deemed outstanding for computing the percentage of any other person.
Unless otherwise indicated, the address of each beneficial owner listed in the table below is c/o Akers Biosciences, Inc., 201 Grove
Road, Thorofare, New Jersey USA 08086.
64
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Name of Beneficial Owner:
5% Stockholders:
Chubeworkx Guernsey Limited (1)
Act Capital Management, LLLP
Named Executive Officers and Directors:
Raymond F. Akers, Jr. Phd(2)
Tom Knox
Brandon Knox
Gavin Moran(3)
Robert E. Andrews
Dr. Raza Bokhari
Gary M. Rauch
All executive officers and directors as a group (6 persons)
Percentage of
Ownership
as of
March 25, 2016
9.45 %
5.16 %
0.00 %
9.18 %
2.91 %
1.01 %
0.89 %
0.59 %
0.78 %
15.36 %
(1) Mark Chasey is the Chairman of Chubeworkx Guernsey Limited and has beneficial ownership of the shares.
(2) Dr. Akers previously gifted 70,000 shares of Common Stock to the Akers Family Trust, a trust to which he is not a named
beneficiary. On January 5, 2016, Dr. Akers’ wife purchased 2,100 shares of Common Stock.
(3) Mr. Gavin Moran was not nominated for re-election as Director in 2015 and served in such capacity until August 3, 2015.
Changes in Control
We are not aware of any arrangements that may result in “changes in control” as that term is defined by the provisions of Item 403(c)
of Regulation S-K.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Other than compensation arrangements, the following is a description of transactions to which we were a participant or will be a
participant to, in which:
●
the amounts involved exceeded or will exceed the lesser of 1% of our total assets or $120,000; and
●
any of our directors, executive officers or holders of more than 5% of our capital stock, or any member of the immediate
family of the foregoing persons, had or will have a direct or indirect material interest.
65
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
On June 19, 2013, the Company entered into a 3 year exclusive License and Supply Agreement ChubeWorkx Guernsey Limited
(“ChubeWorkx”) for the purchase and distribution of the Company’s proprietary breathalyzers outside of North America.
ChubeWorkx paid a licensing fee of $1,000,000 which was recognized over the term of the agreement through June 30, 2015.
On December 31, 2014, the outstanding ChubeWorkx Receivable was converted to a note receivable. The note is payable in sixty
equal installments of $27,734 commencing January 1, 2015 and has an interest rate of 5% per annum.
On June 30, 2014 the Company recorded sales of $864,000 to Thirty Six Strategies General Trading LLC (“36S”). Gavin Moran, a
member of the Company’s Board of Directors, has beneficial ownership in 36S.
On March 9, 2015, the Company contributed capital of $64,675 in Hainan Savy Akers Biosciences, Ltd., a company incorporated in
the People’s Republic of China, resulting in a 19.9% ownership interest. The contribution was adjusted downward to $64,091 on April
8, 2015; the net effect of the currency conversion when the contribution was processed in Hainan. Mr. Thomas Knox, a member of the
Company’s Board of Directors, is also an investor in the joint venture.
Item 14. Principal Accounting Fees and Services.
The following table sets forth the aggregate fees billed for each of the last two fiscal years for professional services rendered by the
principal accountant for the audit of the Company’s annual financial statements and review of financial statements included in the
Company’s quarterly reports or services that are normally provided by the accountant in connection with statutory and regulatory
filings or engagements for those fiscal years.
Audit-Related fees include services for the review of interim financial statements, tax fees include the preparation of tax returns and
other fees include services performed in relation to the preparation of Form S-1 for the initial public offering on NASDAQ and
advisory services.
Audit Fees
Audit-Related Fees
Tax Fees
All Other Fees
TOTAL
2015
2014
$
$
$
$
$
60,318 $
54,800 $
5,500 $
4,648 $
125,266 $
55,514
51,000
5,516
16,600
128,630
66
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Item 15. Exhibits, Financial Statement Schedules.
Exhibit
Number
PART IV
Description of Exhibit
1.1
3.1
3.2
3.3
3.4
3.5
4.1
5.1
10.1
10.2
10.3
10.4
Form of Underwriting Agreement (incorporated by reference to Exhibit 1.1 to the to the Company’s Registration Statement
on Form S-1 filed with the Securities Exchange Commission on November 18, 2013).
Amended & Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Company’s
Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 7, 2013).
Amendment to Certificate of Incorporation dated June 2, 2008 (incorporated herein by reference to Exhibit 3.2 to the
Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 7, 2013).
Amendment to Certificate of Incorporation, Certificate of Designation of Series A Preferred Stock, dated September 21,
2012. (incorporated herein by reference to Exhibit 3.3 to the Company’s Registration Statement on Form S-1 filed with the
Securities and Exchange Commission on August 7, 2013).
Amendment to Certificate of Incorporation dated January 22, 2013 (incorporated herein by reference to Exhibit 3.4 to the
Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 7, 2013).
Amended and Restated By-laws dated August 5, 2013(incorporated herein by reference to Exhibit 3.5 to the Company’s
Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 7, 2013).
Form of Underwriters’ Warrant (incorporated by reference to Exhibit 4.1 to the to the Company’s Registration Statement
on Form S-1 filed with the Securities Exchange Commission on November 18, 2013).
Opinion of Lucosky Brookman LLP (incorporated by reference to exhibit 5.1 to the Company’s Registration Statement on
Form S-1 filed with the Securities and Exchange Commission on December 30, 2013).
Employment Agreement, dated January 12, 2011 between Raymond F. Akers, Jr. Phd and Akers Biosciences, Inc. and
letter of amendment dated August 3, 2013. (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration
Statement on Form S-1 filed with the Securities and Exchange Commission on August 7, 2013).
Consulting Agreement between Akers Biosciences, Inc. and Nicolette Consulting Group, dated January 12,
2011(incorporated herein by reference to Exhibit 10.2 to the Company’s Registration Statement on Form S-1 filed with the
Securities and Exchange Commission on August 7, 2013).
Consulting Agreement between Akers Biosciences, Inc. and DataSys Solutions, LLC, dated January 1, 2012. (incorporated
herein by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on August 7, 2013).
Amended License and Supply Agreement by and between Akers Biosciences, Inc. and Chubeworkx Guernsey Limited (as
successor to Sono International Limited) (“Chubeworkx”), (EN)10 (Guernsey) Limited (formerly BreathScan International
(Guernsey) Limited) and (EN)10 Limited (formerly BreathScan International Limited), dated June 12, 2013 (incorporated
herein by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on August 7, 2013).
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
10.5
10.6
10.7
10.8
Share Purchase Agreement by and between Akers Biosciences, Inc. and Chubeworkx, dated June 12, 2013. (incorporated
herein by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on August 7, 2013)
Voting Agreement by and between Akers Biosciences, Inc., Chubeworkx and Thomas J. Knox, dated June 12,
2013(incorporated herein by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 filed with the
Securities and Exchange Commission on August 7, 2013).
Subscription Agreement by and between Akers Biosciences, Inc. and Chubeworkx, dated June 12, 2013(incorporated
herein by reference to Exhibit 10.7 to the Company’s Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on August 7, 2013).
Subscription Agreement by and between Akers Biosciences, Inc. and Thomas J. Knox, dated September 14,
2012(incorporated herein by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 filed with the
Securities and Exchange Commission on August 7, 2013).
67
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
10.9
10.10
10.11
10.12
10.13
10.14
10.15
10.16
10.17
10.18
10.19
10.20
10.21
10.22
Promissory Note entered into by Thomas J Knox issued in favor of Akers Biosciences, Inc., dated September 14, 2012.
(incorporated herein by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 filed with the
Securities and Exchange Commission on August 7, 2013).
License and Supply Agreement by and among the Company, Sono International Limited (“SIL”), BreathScan International
(Guersney) Limited and BreathScan International Limited, dated June 19, 2012 (incorporated herein by reference to Exhibit
10.10 to the Company’s Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on October
8, 2013).
Distribution Agreement by and among the Company and Fisher Healthcare, and Amendment thereto, dated June 15, 2010 and
May 1, 2012, respectively. (incorporated herein by reference to Exhibit 10.11 to the Company’s Registration Statement on
Form S-1/A filed with the Securities and Exchange Commission on October 8, 2013).
National Brand Distribution Agreement by and among the Company and Cardinal Health 2000, and Amendment thereto, dated
May 1, 2007 and June 1, 2008, respectively. (incorporated herein by reference to Exhibit 10.12 to the Company’s Registration
Statement on Form S-1/A filed with the Securities and Exchange Commission on October 8, 2013).
Promissory Note entered into by Thomas J. Knox issued in favor of Akers Biosciences, Inc, dated November 15,
2013(incorporated herein by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1/A filed with the
Securities and Exchange Commission on November 18, 2013).
2013 Incentive Stock and Award Plan (incorporated herein by reference to Exhibit 10.14 to the Company’s Registration
Statement on Form S-1/A filed with the Securities and Exchange Commission on December 6, 2013).
Form of Nonqualified Stock Option Agreement (Non-Employee) (incorporated herein by reference to Exhibit 10.15 to the
Company’s Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on December 6, 2013).
Form of Nonqualified Stock Option Agreement (Employee) (incorporated herein by reference to Exhibit 10.16 to the
Company’s Registration Statement on Form S-1/A filed with the Securities and Exchange Commission on December 6, 2013).
Form of Restricted Stock Agreement (incorporated herein by reference to Exhibit 10.17 to the Company’s Registration
Statement on Form S-1/A filed with the Securities and Exchange Commission on December 6, 2013).
Form of Incentive Stock Option (incorporated herein by reference to Exhibit 10.18 to the Company’s Registration Statement on
Form S-1/A filed with the Securities and Exchange Commission on December 6, 2013).
Letter Agreement, dated December 3, 2013, by and between the Company and Mr. Tom Knox (incorporated herein by
reference to Exhibit 10.19 to the Company’s Registration Statement on Form S-1/A filed with the Securities and Exchange
Commission on December 6, 2013).
Joint Venture Agreement, dated October 24, 2014, by and between Akers Biosciences, Inc., Hainan Savy Investment
Management Ltd, and Thomas Knox (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on October 29, 2014).
Amended and Restated 2013 Incentive Stock and Award Plan (incorporated herein by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 9, 2015).
Form of Lock Up Agreement (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K
filed with the Securities and Exchange Commission on January 9, 2015).
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
10.23
17.1
31.1*
31.2*
32.1*
32.2*
Employment Agreement between the Company and John J Gormally, dated December 1, 2015. (incorporated herein by
reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on
December 3, 2015)
Letter of Resignation from Thomas Nicolette dated March 7, 2014 (incorporated herein by reference to Exhibit 17.1 to the
Company’s Current Report on Form 8-K filed March 12, 2014).
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))
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))
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
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
* Filed herewith
Unless otherwise indicated, exhibits were previously filed with this registration statement.
68
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
Pursuant to the requirements of Section 13 or 15(d) of the Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
SIGNATURES
Date: March 30, 2016
Date: March 30, 2016
AKERS BIOSCIENCES, INC.
By:
Name:
Title:
/s/ John Gormally
John Gormally
(Principal Executive Officer)
/s/ Raymond Akers Jr.
By:
Name: Raymond Akers Jr.
Title:
(Principal Financial Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on
behalf of the registrant and in the capacities and on the dates indicated.
Name
Position
/s/ Raymond Akers Jr.
Raymond Akers Jr.
/s/ Thomas Knox
Thomas Knox
/s/ Brandon Knox
Brandon Knox
/s/ Robert E Andrews
Robert E. Andrews
/s/ Dr. Raza Bokhari
Dr. Raza Bokhari
Executive Chairman
Director
Director
Director
Director
69
Date
March 30, 2016
March 30, 2016
March 30, 2016
March 30, 2016
March 30, 2016
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
FINANCIAL STATEMENTS
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Stockholders’ Deficit
Consolidated Statements of Cash Flows
Notes to the Consolidated Financial Statements
F-1
Page
F-2
F-3
F-4
F-5
F-6
F-7
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Akers Biosciences, Inc. and Subsidiaries
We have audited the accompanying consolidated balance sheets of Akers Biosciences, Inc. and Subsidiaries (the “Company”) as of
December 31, 2015 and 2014, and the related consolidated statements of operations and comprehensive loss, changes in stockholders’
equity, and cash flows for the years then ended. These consolidated financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial
statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its
internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the
effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such an opinion. An audit
includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also
includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the consolidated financial
position of Akers Biosciences, Inc. and Subsidiaries at December 31, 2015 and 2014, and the consolidated results of their operations
and their cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of
America.
Blue Bell, Pennsylvania
March 30, 2016
F-2
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
December 31, 2015 and 2014
ASSETS
Current Assets
Cash
Marketable Securities
Trade Receivables (net)
Trade Receivables - Related Party, net
Notes Receivable - Related Party, net
Other Receivables
Inventories (net)
Other Current Assets
Total Current Assets
Non-Current Assets
Notes Receivable - Related Party, net
Property, plant and equipment, net
Intangible assets, net
Other Assets
Total Non-Current Assets
Total Assets
LIABILITIES
Current Liabilities
Trade and Other Payables
Deferred Revenue - Related Party
Total Current Liabilities
Total Liabilities
STOCKHOLDERS’ EQUITY
Convertible Preferred Stock, No par value, 50,000,000 shares authorized, no shares
issued and outstanding as of December 31, 2015 and 2014
Common Stock, No par value, 500,000,000 shares authorized, 5,425,045 and
4,954,837 issued and outstanding as of December 31, 2015 and 2014
Accumulated Deficit
Accumulated Other Comprehensive Loss
Total Stockholders’ Equity
Total Liabilities and Stockholders’ Equity
2015
2014
402,059
4,025,104
609,195
31,512
-
95,577
1,131,654
185,967
455,841
9,264,961
1,154,290
864,000
266,457
41,435
905,116
107,633
6,481,068
13,059,733
-
251,145
1,472,883
66,813
1,209,309
201,483
2,176,065
4,282
1,790,841
3,591,139
8,271,909
16,650,872
1,668,731
-
1,538,430
305,556
1,668,731
1,843,986
1,668,731
1,843,986
-
-
100,785,408
(94,175,999 )
(6,231 )
99,691,096
(84,864,086 )
(20,124 )
6,603,178
14,806,886
8,271,909
16,650,872
The accompanying notes are an integral part of these consolidated financial statements.
F-3
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Income
Revenues:
Product Revenue
Product Revenue - Related parties
License Revenue
License Revenue - Related party
Total Revenues
Cost of Sales:
Product Cost of Sales
Gross Profit
Administrative Expenses
Administrative Expenses - Related parties
Sales and Marketing Expenses
Research and Development Expenses
Bad Debt Expenses - Related parties
Impairment of Non-Current Assets
Amortization of Non-Current Assets
Loss from Operations
Other (Income)/Expenses
Foreign Currency Transaction (Gain)/Loss
Gain from demutualization of insurance carrier
Interest and Dividend Income
Total Other Income
Loss Before Income Taxes
Income Tax Benefit
Preferred Stock Dividend
$
Years ended
December 31,
2015
2014
1,757,982 $
36,512
15,000
305,556
2,115,050
2,453,462
1,630,379
10,000
333,333
4,427,174
(950,792 )
(1,175,232 )
1,164,258
3,251,942
4,029,516
-
2,543,286
1,406,895
2,163,609
466,476
236,706
3,784,078
195,002
1,302,103
916,308
-
-
258,572
(9,682,230 )
(3,204,121 )
7,535
(6,052 )
(102,456 )
(100,973 )
(2,667 )
(4,669 )
(69,618 )
(76,954 )
(9,581,257 )
(3,127,167 )
269,344
-
-
(15,793 )
Net Loss Attributable to Common Stockholders
(9,311,913 )
(3,142,960 )
Other Comprehensive Income/(Loss)
Unrealized Gains/(Losses) on Marketable Securities
Total Other Comprehensive Income/(Loss)
13,893
13,893
(20,124 )
(20,124 )
Comprehensive Loss
$
(9,298,020 ) $
(3,163,084 )
Basic & diluted loss per common share
$
(1.81 ) $
(0.66 )
Weighted average basic & diluted common shares outstanding
5,140,920
4,745,684
The accompanying notes are an integral part of these consolidated financial statements.
F-4
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Statement of Changes in Stockholder’s Equity
Years ended December 31, 2015 and 2014
Common
Shares
Issued and
Outstanding
Common
Stock
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income/(Loss)
Total
Equity
Balance at December 31, 2013
2,167,837 $
85,843,360 $
(81,721,126 ) $
- $
4,122,234
Net loss for the period
Divends paid on Series A
Convertible Preferred Stock
Initial public offering net of
offering costs of $1,897,164
Issuance of Non-Qualified
Stock Options for Directors
and Officers
Issuance of Non-Qualified
Stock Options for Key
Employees
Issuance of Restricted
Common Stock for services
Unrealized loss on
marketable securities
-
-
-
-
(3,127,167 )
-
(3,127,167 )
(15,793 )
-
(15,793 )
2,727,000
13,101,336
-
357,276
-
192,324
60,000
196,800
-
-
-
-
-
-
-
-
13,101,336
-
357,276
-
192,324
-
196,800
(20,124 )
(20,124 )
Balance at December 31, 2014
4,954,837 $
99,691,096 $
(84,864,086 ) $
(20,124 ) $ 14,806,886
Net loss for the period
Issuance of Restricted
Common Stock for Directors
& Officers
Issuance of Restricted
Common Stock for Key
Employees
Issuance of Restricted
Common Stock for services
Issuance of Non-Qualified
Stock Options for Key
Employees
Issuance of Non-Qualified
Stock Options for services
from non-employees
Unrealized gain on
marketable securities
-
-
(9,311,913 )
-
(9,311,913 )
417,708
977,381
22,500
27,675
30,000
36,900
-
23,636
-
28,720
-
-
-
-
-
-
977,381
-
27,675
-
36,900
-
23,636
-
28,720
-
-
-
13,893
13,893
Balance at December 31, 2015
5,425,045 $
100,785,408 $
(94,175,999 ) $
(6,231 ) $
6,603,178
The accompanying notes are an integral part of these consolidated financial statements.
F-5
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
Years ended December 31, 2015 and 2014
Cash flows from operating activities
Net loss for the year
Adjustments to reconcile net loss to net cash used in operating activities:
Accrued interest and dividends on marketable securities
Decrease in reserve for inventory obsolescence
Depreciation and amortization
Impairment of non-current assets
Allowance for doubtful accounts
Gain from other non-operating activities
Non-cash share based compensation - options
Non-cash share based payments for services - shares issued
Changes in assets and liabilities:
(Increase)/decrease in trade receivables
(Increase)/decrease in notes receivables - related party
Increase in other receivables
(Increase)/decrease in inventories
(Increase)/decrease in other assets
Increase in trade and other payables
Decrease in other payables - related party
Decrease in deferred revenue - related party
Net cash used in operating activities
Cash flows from investing activities
Purchases of property, plant and equipment
Purchases of marketable securities
Investment in Hainan Savy Akers Biosciences, Ltd. joint venture
Proceeds from demutualization of insurance carrier
Proceeds from sale of marketable securities
Net cash provided by/(used in) investing activities
Cash flows from financing activities
Payment of short-term note payable - related party
Proceeds from issuance of common shares
Net proceeds from issuance of common stock in initial public offering
Dividend distribution on Series A Convertible Preferred Stock
Net cash provided by financing activities
Net increase/(decrease) in cash
Cash at beginning of year
Cash at end of year
Supplemental Schedule of Non-Cash Financing and Investing Activities
Unrealized gains/(losses) on marketable securities
Conversion of trade receivable as of December 31, 2013 to a note receivable in the
year ended December 31, 2014
2015
2014
$
(9,311,913 ) $
(3,127,167 )
4,199
-
299,995
466,476
2,163,609
(6,052 )
52,356
344,656
513,583
176,157
(54,142 )
(226,538 )
(76,774 )
827,601
-
(305,556 )
(5,132,343 )
(112,951 )
(60,940 )
(64,091 )
6,052
5,310,491
5,078,561
-
-
-
-
-
(18,473 )
(3,061 )
349,398
-
-
(4,669 )
549,600
196,800
(1,899,886 )
(266,378 )
(37,497 )
123,049
56,257
538,017
(6,586 )
(333,333 )
(3,883,929 )
(24,988 )
(12,551,106 )
-
4,669
3,284,494
(9,286,931 )
(307,500 )
745,024
13,101,336
(15,793 )
13,523,067
(53,782 )
455,841
402,059 $
352,207
103,634
455,841
13,893 $
(20,124 )
- $
1,209,388
$
$
$
Issuance of restricted common share grants to directors and officers accrued in 2014
$
697,300 $
-
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The accompanying notes are an integral part of these consolidated financial statements.
F-6
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Note 1 - Nature of Business
(a) Reporting Entity
The accompanying audited financial statements have been prepared by Akers Biosciences, Inc. (“ABI” or the
“Company”), a company domiciled in the United States of America. The address of the Company’s registered office is
201 Grove Road, West Deptford, New Jersey, 08086. The Company is incorporated in the United States of America
under the laws of the State of New Jersey.
The consolidated financial statements include two dormant subsidiaries, Akers Acquisition Sub, Inc. and Bout Time
Marketing Corporation. All material intercompany transactions have been eliminated upon consolidation.
(b) Nature of Business
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.
When the Company enters into an agreement with a new distributor it typically requires an upfront licensing fee to be
paid for the right to sell the Company’s products in specific markets.
Note 2 - Basis of Presentation
(a) Statement of Compliance
The 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).
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. In particular, 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.
F-7
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(c) Functional and Presentation Currency
These 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
consolidated statement of operations and comprehensive loss.
(d) Comprehensive Income
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.
Note 3 - Significant Accounting Policies
(a) 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 consolidated balance sheet.
(b) 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 Company believes the carrying amount of its note
receivable approximates its fair value based on rates and other terms. The fair value of marketable securities is described
in Note 3(c).
(c) Fair Value Measurement - Marketable Securities
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:
F-8
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Level
1
Inputs to the valuation methodology are unadjusted quoted prices for identical assets or liabilities 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
3
Inputs to the valuation methodology are unobservable and significant to the fair value measurement.
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.
(d) 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.
The normal credit terms extended to customers ranges between 30 and 90 days. 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 December 31, 2015 and 2014, allowances for doubtful accounts for trade receivables - related party were
$864,000 and $-. Bad debt expenses for trade receivables were $864,000 and $- for the years ended December 31, 2015
and 2014.
F-9
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(e) Concentration of Credit Risk
The Company is exposed to credit risk in the normal course of business primarily related to trade receivables and cash
and cash equivalents.
All of the Company’s cash is maintained with Fulton Bank of New Jersey, Bank of America, NA and PayPal. The funds
are insured by the FDIC up to a maximum of $250,000, but are otherwise unprotected. The Company placed $369,525
and $399,417 with Fulton Bank of New Jersey, $28,494 and $52,384 with Bank of America, NA and $4,040 and $4,040
with PayPal as of December 31, 2015 and 2014. No losses have been incurred in these accounts.
Concentration of credit risk with respect to trade receivables exists as approximately 72% of the Company’s revenue is
generated by two customers. These customers accounted for 28% of trade receivables as of December 31, 2015. In order
to limit such risks, the Company performs ongoing credit evaluations of its customers’ financial condition.
(f) Inventories
Inventories are measured at the lower of cost or market. 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 overheads based on normal operating capacity.
(g) 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 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.
F-10
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
The estimated useful lives for the current and comparative periods are as follows:
Plant and equipment
Furniture and fixtures
Computer equipment & software
Useful Life
(in years)
5-12
5-10
3-5
Depreciation methods, useful lives and residual values are reviewed at each reporting date.
(h) Intangible Assets
(i) Patents and Trade Secrets
The Company has developed or acquired several diagnostic tests that can detect the presence of various substances in
a person’s breath, blood, urine and saliva. Propriety protection for the Company’s products, technology and process
is important to its competitive position. To date, the Company has nine patents from the United States Patent Office
in effect (7,896,167, 8,097,171, 8,003,061, 8,425,859, 5,565,366, 5,827,749, D691,056, D691,057 and D691,058).
Other patents are in effect in Australia through the Design Registry (348,310, 348,311 and 348,312), the Community
Trade Mark in the European Union ((OHIM) 002216895-0001, 002216895-0002 and 002216895-0003) and in Japan
(4,885,134 and 4,931,821). Patents are in the national phase of prosecution in many Patent Cooperation Treaty
participating countries. Additional proprietary technology consists of numerous different inventions. The Company
intends to file additional patent applications, where appropriate, relating to new products, technologies and their use
in the U.S., European and Asian markets. Management intends to protect all other intellectual property (e.g.
copyrights, trademarks and trade secrets) using all legal remedies available to the Company.
(ii) Patent Costs
Costs associated with applying for patents are capitalized as patent costs. Once the patents are approved, the
respective costs are amortized over their estimated useful lives (maximum of 17 years) on a straight-line basis.
Patent pending costs for patents that are not approved are charged to operations the year the patent is rejected.
In addition, patents may be purchased from third parties. The costs of acquiring the patent are capitalized as patent
costs if it represents a future economic benefit to the Company. Once a patent is acquired it is amortized over its
remaining useful life.
(iii) Other Intangible Assets
Other intangible assets that are acquired by the Company, which have definite useful lives, are measured at cost less
accumulated amortization and accumulated impairment losses.
F-11
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(iv) Amortization
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. The estimated useful lives for the current and comparative
periods are as follows:
Patents and trademarks
Customer lists
(i) Recoverability of Long Lived Assets
Useful Life
(in years)
12-17
5
In accordance with FASB ASC 360-10-35 “Impairment or Disposal of Long-lived Assets”, long-lived assets to be held
and used are analyzed for impairment whenever events or changes in circumstances indicate that the carrying amount of
an asset may not be fully recoverable or that the useful lives of those assets are no longer appropriate. The Company
evaluates at each balance sheet date whether events and circumstances have occurred that indicate possible impairment.
The Company determines the existence of such impairment by measuring the expected future cash flows (undiscounted
and without interest charges) and comparing such amount to the carrying amount of the assets. An impairment loss, if
one exists, is then measured as the amount by which the carrying amount of the asset exceeds the discounted estimated
future cash flows. Assets to be disposed of are reported at the lower of the carrying amount or fair value of such assets
less costs to sell. Asset impairment charges are recorded to reduce the carrying amount of the long-lived asset that will
be sold or disposed of to their estimated fair values. Charges for the asset impairment reduce the carrying amount of the
long-lived assets to their estimated salvage value in connection with the decision to dispose of such assets.
(j) Investments
In accordance with FASB ASC 323, the Company recognizes investments in joint ventures based upon the Company’s
ability to significantly influence the operational or financial policies of the joint venture. An objective judgment of the
level of influence is made at the time of the investment based upon several factors including, but not limited to the
following:
a) Representation on the Board of Directors
b) Participation in policy-making processes
c) Material intra-entity transactions
d) Interchange of management personnel
e) Technological dependencies
f)
Extent of ownership and the ability to influence decision making based upon the makeup of other owners when
the shareholder group is small.
F-12
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
The Company follows the equity method for valuating investments in joint ventures when the existence of significant
influence over operational and financial policy has been established, as determined by management; otherwise, the
Company will valuate these investments using the cost method.
Investments recorded using the cost method will be assessed for any decrease in value that has occurred that is other
than temporary and the other than temporary decrease in value shall be recognized. As and when circumstances and
facts change, the Company will evaluate the Company’s ability to significantly influence operational and financial
policy to establish a basis for converting the investment accounted for using the cost method to the equity method of
valuation.
On March 9, 2015, the Company contributed capital of $64,675 in Hainan Savy Akers Biosciences, Ltd., a company
incorporated in the People’s Republic of China, resulting in a 19.9% ownership interest. The contribution was adjusted
downward to $64,091 on April 8, 2015; the net effect of the currency conversion when the contribution was processed in
Hainan. This is included in other assets in the consolidated balance sheet as of December 31, 2015 and is accounted for
using the cost method.
(k) 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 $- as of December 31,
2015 and 2014.
The Company instituted a significant price increase for certain PIFA products effective May 1, 2015. In an effort to
phase in the increase for existing customers, the Company is providing a rebate to its distributors for the price increase
through December 31, 2015 for their existing customer base as of April 30, 2015. The Company has established an
accrual of $181,293, which is a reduction of revenue, for the year ended December 31, 2015. Accounts receivable will
be reduced when the rebates are applied by the customer.
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.
F-13
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(l) Income Taxes
The Company follows FASB ASC 740 when accounting for income taxes, which requires an asset and liability approach
to financial accounting and reporting for income taxes. Deferred income tax assets and liabilities are computed annually
for temporary differences between the financial statements and tax bases of assets and liabilities that will result in
taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the periods in which the
differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce
deferred tax assets to the amount expected to be realized. Income tax expense or benefit is the tax payable or refundable
for the period plus or minus the change during the period in deferred tax assets and liabilities.
(m) Shipping and Handling Fees and Costs
The Company charges actual shipping plus a handling fee to customers, which amounted to $56,537 and $35,454 for the
years ended December 31, 2015 and 2014. These fees are classified as part of product revenue in the consolidated
statement of operations and comprehensive loss. Shipping and other related delivery costs, including those for incoming
raw materials are classified as part of the cost of net revenue, which amounted to $115,423 and $71,416 for the years
ended December 31, 2015 and 2014.
(n) Research and Development Costs
In accordance with FASB ASC 730, research and development costs are expensed when incurred.
(o) Stock-based Payments
The Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation-Stock
Compensation”, which requires the measurement and recognition of compensation expense for all stock-based awards
made to employees and directors based on estimated fair values on the grant date. The Company estimates the fair value
of stock-based awards on the date of grant using the Black-Scholes model. The value of the portion of the award that is
ultimately expected to vest is recognized as expense over shorter of the period over which services are to be received or
the vesting period.
The Company accounts for stock-based compensation awards to non-employees in accordance with FASB ASC 505-50,
“Equity-Based Payments to Non-Employees”. Under FASB ASC 505-50, the Company determines the fair value of the
stock warrants or stock-based compensation awards granted as either the fair value of the consideration received or the
fair value of the equity instruments issued, whichever is more reliably measurable.
F-14
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
The Company estimates the fair value of stock-based awards to non-employees on the date of grant using the
Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense
over the period which services are to be received. At the end of each financial reporting period, prior to vesting or prior
to completion of services, the fair value of equity based payments will be re-measured and the non-cash expense
recognized during the period will be adjusted accordingly. Since the fair value of equity based payments granted to
non-employees is subject to change in the future, the amount of the future expense will include fair value
re-measurement until the equity based payments are fully vested or the service is completed.
(p) 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.
(q) Recently Adopted Accounting Pronouncements
As of December 31, 2015 and for the year then ended, there were no recently adopted accounting pronouncements that
had a material effect on the Company’s financial statements.
(r) Recently Issued Accounting Pronouncements not Yet Adopted
As the Company is an emerging growth company, it has elected to adopt recently issued standards based on effective
dates applicable to nonpublic entities. All effective dates as mentioned in the following paragraphs refer to that
applicable to nonpublic entities.
In May 2014, the FASB issued ASU No. 2014-09, 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. Early application is permitted only as of annual reporting periods beginning
after December 15, 2016. The Company is evaluating the effect of the adoption of this standard.
In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern (Subtopic
205-40), Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern . The amendments in this
Update provide guidance about management’s responsibility to evaluate whether there are conditions or events,
considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within
one year after the date that the financial statements are issued and to provide related footnote disclosures. Substantial
doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in
the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within
one year after the date that the financial statements are issued. The amendments in this Update are effective for the
annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application
is permitted. The Company is evaluating the effect of the adoption of this standard.
F-15
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330), Simplifying the Measurement of Inventory.
The amendments in this Update require an entity to measure inventory at the lower of cost or net realizable value. Net
realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of
completion, disposal, and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or
the retail inventory method. The amendments in this Update are effective for fiscal years beginning after December 15,
2016. The Company does not anticipate the adoption of this standard to have any material effect on the financial
statements.
In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740), Balance Sheet Classification of
Deferred Taxes . The amendments in this Update require that deferred tax liabilities and assets be classified as
noncurrent in a classified statement of financial position. The amendments in this Update are effective for financial
statements issued for annual periods beginning after December 15, 2017, and interim periods within those annual
periods. Earlier application is permitted as of the beginning of an interim or annual reporting period. As of December
31, 2015, the Company adopted this standard which has no material effect on the financial statements.
Note 4 - Fair Value Measurement - Marketable Securities
Following is a description of the valuation methodologies used for assets measured at fair value as of December 31,
2015 and 2014.
U.S. Agency Securities, Corporate and Municipal Securities and Certificates of Deposits: 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.
Accrued
Income
Cost
Unrealized Unrealized
Gains
Losses
Fair
Value
2015
Level 2:
Money market funds
Certificates of deposits
Corporate securities
Municipal securities
Total Level 2:
$
750 $
2,050,000
1,528,308
438,003
4,017,061
- $
8,584
4,934
756
14,274
- $
-
-
-
-
- $
750
(135 ) 2,058,449
(5,918 ) 1,527,324
438,581
(6,231 ) 4,025,104
(178 )
Total:
$ 4,017,061 $
14,274 $
- $
(6,231 ) $ 4,025,104
F-16
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Cost
Accrued
Income
2014
Unrealized
Gains
Unrealized
Losses
Fair Value
$
1,795 $
297,699
3,430,000
1,528,308
4,008,811
9,266,613
- $
360
10,653
5,037
2,422
18,472
- $
-
-
-
-
-
- $
(141 )
(11,236 )
(6,631 )
(2,116 )
(20,124 )
1,795
297,918
3,429,417
1,526,714
4,009,117
9,264,961
Level 2:
Money market funds
US agency securities
Certificates of deposits
Corporate securities
Municipal securities
Total Level 2:
Total:
$ 9,266,613 $
18,472 $
- $
(20,124 ) $ 9,264,961
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 range from one to twenty
years. Unrealized gains/(losses) relating to the available for sale investment securities were recorded in the consolidated
statement of changes in stockholders’ equity as comprehensive income. These amounts were $13,893 and ($20,124) (net
of effect of income tax expense of $-) for the years ended December 31, 2015 and 2014.
As of December 31, 2015, investments in U.S. agency securities, corporate securities and municipal securities classified
as available for sale mature as follows:
Within
1 Year
1 - 5 Years
After
10 Years
$
294,622 $
3,630,455 $
100,027
Proceeds from the sale of marketable securities in the year ended December 31, 2015 and 2014 were $5,310,491 and
$3,284,494. Gross gain and gross loss as a result of the sales amounted to $1,594 and $8,105 for December 31, 2015 and
$861 and $110 for December 31, 2014.
Note 5 - Trade Receivables - Related Party
The Company reclassified the trade receivable of $864,000 from Thirty Six Strategies General Trading LLC (“36S”) as
a trade receivable - related party in 2015 (Note 16). As a result, the Company also reclassified this trade receivable on
the condensed consolidated balance sheet as of December 31, 2014. The amount due is non-interest bearing, unsecured
and has a term of 360 days which was due June 30, 2015. As of June 30, 2015, the Company established an allowance
for doubtful accounts of $864,000 which is reported as bad debts expense - related parties in the consolidated statement
of operations and comprehensive income for the year ended December 31, 2015 (Note 16).
The Company continues to work with 36S to gain approval of the Company’s Tri-Cholesterol product in Australia.
F-17
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Note 6 - Note Receivable - Related Parties
On December 31, 2014 a note of $1,475,766 was issued to the Company in exchange for the Company’s open trade
receivables from ChubeWorkx Guernsey Limited, a major shareholder. It is payable in sixty equal installments of
$27,734 commencing January 1, 2015 and has an interest rate of 5% per annum.
In the event of default, the Company, at its sole discretion, has the right to redeem any and all Company shares owned
by ChubeWorkx Guernsey Limited to satisfy the monies owed to the Company under this note.
As of December 31, 2015 the company established an allowances for doubtful accounts for notes receivable - related
party of $1,299,609 which is reported as bad debt expense - related parties in the consolidated statement of operations
and comprehensive income for the year ended December 31, 2015 (Note 16).
Note 7 - Inventories
Inventories at December 31, 2015 and 2014 consists of the following categories:
Raw Materials
Sub-Assemblies
Finished Goods
Reserve for Obsolescence
2015
$
348,216 $
786,656
25,721
(28,939 )
$ 1,131,654 $
2014
413,897
433,793
86,365
(28,939 )
905,116
For the years ended December 31, 2015 and 2014 $- was charged to cost of goods sold for obsolete inventory.
Note 8 - Property, Plant and Equipment
Property, plant and equipment as of December 31, 2015 and 2014 are as follows:
Computer Equipment
Computer Software
Office Equipment
Furniture & Fixtures
Machinery & Equipment
Molds & Dies
Leasehold Improvements
Less
Accumulated Depreciation
$
2015
2014
100,405 $
40,681
50,049
29,939
1,112,060
756,279
222,593
2,312,006
100,405
30,736
50,049
29,939
1,111,005
654,327
222,594
2,199,055
2,060,861
1,997,572
$
251,145 $
201,483
During the years ended December 31, 2015 and 2014 depreciation expense was $63,289 and $90,826.
F-18
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Note 9 - Intangible Assets
Intangible assets as of December 31, 2015 and 2014 and the movements for the years then ended are as follows:
Cost or Deemed Cost
At December 31, 2013
Additions
Disposal
At December 31, 2014
Accumulated Amortization
At December 31, 2013
Amortization Charge
Disposal
At December 31, 2014
Net Book Value
At December 31, 2013
At December 31, 2014
Cost or Deemed Cost
At December 31, 2014
Additions
Disposal
At December 31, 2015
Accumulated Amortization
At December 31, 2014
Amortization Charge
Disposal
At December 31, 2015
Net Book Value
At December 31, 2014
At December 31, 2015
Patents &
Trademarks
Distributor &
Customer
Relationships
Totals
$
$
$
$
$
$
$
$
$
$
$
$
3,851,494 $
-
-
3,851,494 $
1,270,639 $
-
-
1,270,639 $
5,122,133
-
-
5,122,133
1,416,857 $
258,572
-
1,675,429 $
1,270,639 $
-
-
1,270,639 $
2,687,496
258,572
-
2,946,068
2,434,637 $
2,176,065 $
- $
- $
2,434,637
2,176,065
3,851,495 $
-
(1,224,499 )
2,626,996 $
1,270,639 $
-
-
1,270,639 $
5,122,134
-
(1,224,499 )
3,897,635
1,675,430 $
236,706
(758,023 )
1,154,113 $
1,270,639 $
-
-
1,270,639 $
2,946,069
236,706
(758,023 )
2,424,752
2,176,065 $
1,472,883 $
- $
- $
2,176,065
1,472,883
On December 31, 2015, the Company reassigned two fully amortized patents to the original holder as part of the
settlement of a legal dispute.
During the years ended December 31, 2015 and 2014 amortization expense was $236,706 and $258,572.
The estimated aggregate amortization expense for each of the five succeeding fiscal years is as follows:
Period
2016
2017
2018
2019
$
$
$
$
Amount
171,108
171,108
171,108
171,108
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
2020
$
171,108
F-19
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Note 10 - Trade and Other Payables
Trade and other payables as of December 31, 2015 and 2014 are as follows:
Trade Payables
Accrued Expenses
Legal Settlements Payable
Deferred Compensation
2015
538,449 $
1,020,532
50,000
59,750
1,668,731 $
2014
377,898
1,100,782
-
59,750
1,538,430
$
$
Trade and other payables are non-interest bearing and are normally settled on 30 - 60 day terms.
Note 11 - Deferred Revenue - Related Party
Deferred revenue represents the unearned revenue from the 3-year exclusive License and Supply Agreement with
ChubeWorkx Guernsey Limited (“ChubeWorkx”)(Note 16) for the purchase and distribution of the Company’s
proprietary breathalyzer that was signed in June 2012. As of December 31, 2014, 8,120,000 units have been shipped.
The license revenue is being recognized monthly on a straight line basis over the 3-year term of the agreement.
On May 7, 2015, the Company and ChubeWorkx mutually terminated the exclusive license and supply agreement that
granted worldwide distribution rights to ChubeWorkx for the Company’s breathalyzer test. As a result of this action and
per the terms of the original agreement, the Company recognized the remaining $166,667 of deferred revenue in the
statement of operations for the year ended December 31, 2015.
Note 12 - 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 “Plan”), which increases the number of authorized shares of common stock subject to the Plan to 800,000
shares.
The 2013 Plan may be 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.
F-20
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(a) Stock Warrants
The Company has issued warrants to various employees, consultants and members of the Board of Directors of the
Company for their services either in connection with the Company’s ongoing efforts to raise capital or the development
of the Company’s products. In addition, the Company has granted warrants to lenders in connection with the issuance of
debt. Each warrant granted may be exchanged for a prescribed number of shares of common stock. The warrants expire
March 18, 2015. The following table summarizes the warrant activities for the years ended December 31, 2015 and
2014:
Balance at December 31, 2014 and 2013
Granted
Exercised
Forfeited
Canceled/Expired
Balance at December 31, 2015
(b) Stock options
Number of
Weighted
Average
Shares
Exercise Price
1,989 $
-
-
-
(1,989 )
- $
71.76
-
-
-
71.76
-
Qualified option holders may exercise their options at their discretion. Each option granted may be exchanged for a
prescribed number of shares of common stock.
On June 10, 2014 the Company approved issuance of 115,000 options to purchase common shares to Directors and
Officers at an exercise price of $5.50 per common share and 60,000 options to purchase common shares to key
employees at an exercise price of $3.98 per common share.
On December 30, 2015 the Company approved the issuance of 30,000 options to purchase common shares to key
employees at an exercise price of $1.23 per common share and 15,500 options to purchase common shares for services
at an weighted average exercise price of $3.70 per common share.
These options were issued under the Amended and Restated 2013 Incentive Stock and Award Plan, in which an
aggregate of up to 800,000 shares of the Company’s common shares are reserved for issuance. All options are
immediately exercisable and carry a five year expiration.
The calculated fair value of these options was distributed to the following categories on the consolidated statement of
operations and comprehensive loss:
Expense Category
Cost of Goods
General & Administrative
Sales & Marketing
Research & Development
2015
2014
5,909 $
-
1,617
44,830
52,356 $
24,040
357,276
48,081
120,203
549,600
$
$
F-21
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
The options and warrants issued under the above plan were valued using a Black Scholes option pricing model. The
assumptions utilized in calculating the value of the issued options under Black Scholes are as follows:
Expected option term
Expected volatility
Expected dividend yield
Risk free interest rate
2015
2014
5 yrs
82.86 %
0.00 %
1.73 %
5 yrs
127.32 %
0.00 %
1.71 %
The following table summarizes the option activities for the years ended December 31, 2015 and 2014:
Weighted
Average
Number of Exercise
Shares
Price
Weighted
Average
Remaining
Contractual
Term (years) Value
Aggregate
Intrinsic
- $
175,000
-
-
-
175,000 $
-
4.98
-
-
-
4.98
175,000 $
4.98
4.50 $
600
175,000 $
45,500
-
-
-
220,500 $
4.98
2.07
-
-
-
4.38
220,500 $
4.38
3.81 $
-
Balance at December 31,
2013
Granted
Exercised
Forfeited
Canceled/Expired
Balance at December 31,
2014
Exercisable as of December
31, 2014
Balance at December 31,
2014
Granted
Exercised
Forfeited
Canceled/Expired
Balance at December 31,
2015
Exercisable as of December
31, 2015
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the
closing stock price of $1.21 and $3.99 for our common shares on December 31, 2015 and 2014.
The total grant date fair value of stock options vested for the years ended December 31, 2015 and 2014 was $52,356 and
$549,600.
As of December 31, 2015 and 2014, there was $- of unrecognized compensation cost related to outstanding employee
stock options.
Note 13 - Equity
The holders of common shares are entitled to one vote per share at meetings of the Company. Holders of Series A
convertible preferred shares are entitled to five votes per share at meetings of the Company.
On January 23, 2014, the Company issued 2,727,000 common shares in an initial public offering on the NASDAQ stock
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
exchange. The transaction was recorded at the value of the net proceeds. The expenses related to this public offering are
as follows:
F-22
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Gross Proceeds:
Underwriter/Aegis Expenses
Underwriter Commission
Underwriter Expenses
Aegis Legal Fees
Aegis Registration Expenses
Aegis Miscellaneous Expenses
Aegis Road Show Expenses
Total
Akers Biosciences Expenses
Legal & Accounting Expenses
Printing & Document Prep
Registration Expenses
Road Show Expenses
Total
Net Procceds:
$
$
14,998,500
1,049,895
149,985
80,000
7,500
36,675
20,000
393,298
62,101
55,946
41,764
1,344,055
553,109
13,101,336
On August 15, 2014, the Company issued 60,000 common shares in exchange for legal services rendered. The fair value
of these shares was $196,800, which was reported as Administrative Expenses on the consolidated statement of
operations and comprehensive loss for the year ended December 31, 2014.
On January 9, 2015, the Company issued 190,000 common shares to directors for services provided to the Company
through December 31, 2014. The fair value of these shares was $697,300, which was reported as Administrative
Expenses on the consolidated statement of operations and comprehensive loss for the year ended December 31, 2014,
and the corresponding liability is included in trade and other payables on the December 31, 2014 consolidated balance
sheet.
On December 29, 2015, the Company issued 227,708 common shares to directors and officers for services rendered to
the Company through December 31, 2015. The fair value of these shares was $280,081, which was reported as
Administrative Expenses on the consolidated statement of operations and comprehensive loss for the year ended
December 31, 2015.
On December 29, 2015, the Company issued 22,500 common shares to key employees for services rendered to the
Company through December 31, 2015. The fair value of these shares was $27,675, which was reported as Research and
Development Expenses on the consolidated statement of operations and comprehensive loss for the year ended
December 31, 2015.
On December 29, 2015, the Company issued 30,000 common shares in exchange for legal services rendered. The fair
value of these shares was $36,900, which was reported as Administrative Expenses on the consolidated statement of
operations and comprehensive loss for the year ended December 31, 2015.
F-23
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
As of December 31, 2015 and 2014 the Company has reserved shares of its common stock as follows:
Reserves for:
Outstanding Warrants
2013 Stock Incentive Plan
Total Reserves
2015
2014
-
220,500
220,500
1,989
175,000
176,989
The following is a reconcilement of the movement of shares of Series A Convertible Preferred stock (preferred stock)
and common stock:
Authorized
Issued
Preferred
Stock
Common
Stock
Preferred
Stock
Common
Stock
50,000,000
500,000,000
-
2,167,837
-
-
-
-
-
-
2,727,000
60,000
50,000,000
500,000,000
-
4,954,837
-
-
-
-
-
-
190,000
280,208
50,000,000
500,000,000
-
5,425,045
Balance at December 31,
2013
Shares Issued:
January 23, 2014
August 15, 2014
Balance at December 31,
2014
Shares Issued:
January 9, 2015
December 29, 2015
Balance at December 31,
2015
Note 14 - Loss per share
The calculation of basic and diluted loss per share at December 31, 2015 and 2014 was based on the loss attributable to
common shareholders of $9,311,913 and $3,142,960. The basic and diluted weighted average number of common shares
outstanding for 2015 and 2014 was 5,140,920 and 4,745,684.
Diluted net loss per share is computed using the weighted average number of common and dilutive potential common
shares outstanding during the period.
Potential common shares consist of options and warrants. Diluted net loss per common share was the same as basic net
loss per common share for the years ended December 31, 2015 and 2014 since the effect of options and warrants would
be anti-dilutive due to the net loss attributable to the common shareholders. Instruments excluded from dilutive earnings
per share, because their inclusion would be anti-dilutive, were as follows: incentive and award stock options - 220,500
for 2015 (2014: 175,000); warrants - for 2015 (2014: 1,989).
F-24
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
Note 15 - Income Tax Expense
The Company’s income tax benefit/(provision) is as follows:
Current
Deferred
Change in Valuation Allowance
Income Tax Benefit
Years Ended December 31
2014
2015
1,295,979
132,379
(1,428,358 )
-
269,344 $
3,795,104 $
(3,795,104 ) $
269,344 $
$
$
During 2015, the Company was approved by the State of New Jersey to sell a portion of its state tax benefits that existed
as of December 31, 2014, pursuant to the Technology Tax Certificate Transfer Program. The Company received net
proceeds of $269,344 for the year ended December 31, 2015 (2014: $-) as a result of the sale of the tax benefits, which
has been included as an income tax benefit in the consolidated statement of operations and comprehensive income.
As of December 31, 2015 and 2014, the Company had Federal net operating loss carry forwards of approximately
$58,000,000 and $51,300,000, expiring through the year ending December 31, 2035. As of December 31, 2015 and
2014, the Company had New Jersey state net operating loss carry forwards of approximately $7,200,000 and
$11,900,000, expiring through the year ending December 31, 2022.
The principle components of the deferred tax assets and related valuation allowances as of December 31, 2015 and 2014
are as follows:
Reserves and other
Net operating loss carry-forwards
Valuation Allowance
Net
Years Ended December 31
2015
2014
2,506,000 $
20,728,000
(23,234,000 )
- $
684,830
18,754,066
(19,438,896 )
-
$
$
The reconciliation of income taxes using the statutory U.S. income tax rate and the benefit from income taxes for the
years ended December 31, 2015 and 2014 are as follows:
Statutory U.S. Federal Income Tax Rate
New Jersey State income taxes, net of U.S.
Federal tax effect
Benefit from sale of New Jersey NOL
Change in Valuation Allowance
Net
Years Ended December 31
2014
2015
(35.0 )%
(35.0 )%
(6.0 )%
(2.9 )%
41.0 %
(2.9 )%
(5.9 )%
0.0 %
40.9 %
0.0 %
The valuation allowance for deferred tax assets as of December 31, 2015 and 2014 was $23,234,000 and $19,438,896.
The change in the total valuation for the years ended December 31, 2015 and 2014 were increases of $3,795,104 and
$1,428,358. In assessing the realization of deferred tax assets, management considers whether it is more likely than not
that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is
dependent upon the generation of future taxable income during the periods in which the net operating losses and
temporary differences become deductible. Management considered projected future taxable income and tax planning
strategies in making this assessment. The value of the deferred tax assets was fully offset by a valuation allowance, due
to the current uncertainty of the future realization of the deferred tax assets.
F-25
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
The Company’s policy is to record interest and penalties associated with unrecognized tax benefits as additional income
taxes in the statement of operations. As of January 1, 2015, the Company had no unrecognized tax benefits and no
charge during 2015, and accordingly, the Company did not recognize any interest or penalties during 2015 related to
unrecognized tax benefits. There is no accrual for uncertain tax positions as of December 31, 2015.
The Company files U.S. federal income tax returns and a state income tax returns. The U.S. and state income tax returns
filed for the tax years ended on December 31, 2012 and thereafter are subject to examination by the relevant taxing
authorities.
Note 16 - Related Party Transactions
On January 12, 2011, the Company entered into a consulting agreement with Nicolette Consulting Group Limited
(NCG) for a period of three years for the services of Mr. Nicolette as President and Chief Executive Officer of the
Company. The consulting agreement was extended through February 11, 2014 on December 23, 2013 and extended
through March 31, 2014 on March 15, 2014. Mr. Nicolette resigned from the Company effective March 28, 2014.
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
ABI’s proprietary breathalyzers outside North America. ChubeWorkx is the 80% shareholder in en(10) Guernsey
Limited, described above. ChubeWorkx paid a licensing fee of $1,000,000, of which $333,333 was recognized as
income for the years ended December 31, 2014 and 2013, with the deferral to be recognized over the remaining term of
the agreement (Note 11).
On June 13, 2013, the Company announced an extension of the License and Supply Agreement with ChubeWorkx to
include worldwide marketing and distribution of the “Be CHUBE” program using the Company’s breathalyzer.
F-26
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
On August 5, 2013, the Board of Directors appointed Gary M. Rauch, the principal of DataSys Solutions, LLC (DS), as
the Corporate Treasurer. The Company entered into a consulting agreement with DS on January 1, 2011, with a term of
three years, under which the Company agreed to pay $5,625 per month for Mr. Rauch’s services as Controller of the
Company. On March 18, 2014, the Board of Directors approved the appointment of Mr. Rauch as Vice President of
Finance, retroactive to February 2, 2014, and he became an employee of the Company.
On December 23, 2013, the Company entered into a short-term bridge loan with Nicolette Consulting Group for
$307,500, payable on January 15, 2014 with a 5% per annum interest rate. The transaction was recorded as a
Short-Term Notes Payable - Related Party. The loan, with interest amounting to $969, was paid in full on January 15,
2014.
On June 30, 2014, the Company recorded a sale of $864,000 to Thirty Six Strategies General Trading LLC (“36S”).
Gavin Moran, a former member of the Company’s Board of Directors, has beneficial ownership in 36S. The trade
receivable - related party as of December 31, 2014 is due from the sale (Note 5).
Trade receivables - related party as of December 31, 2015 are amounts due from Hainan Savy Akers Biosciences Co, a
joint venture partner of the Company of $31,512. As of December 31, 2015, the amount due was non-interest bearing,
unsecured and had a term of 90 days generally.
Notes receivable - related party as of December 31, 2015 and 2014 are amounts due from ChubeWorkx Guernsey
Limited, a major shareholder of the Company of $1,299,609 and $1,475,766.
Product revenue - related parties for the years ended December 31, 2015 and 2014 are $36,512 from Hainan Savy Akers
Biosciences, a joint venture partner for the year ended December 31, 2015 and $1,630,379 from ChubeWorkx Guernsey
Limited, a major shareholder of the Company and 36S, where a former member of the Company’s Board of Directors
has beneficial ownership, for the year ended December 31, 2014.
Administrative expenses - related parties for the year ended December 31, 2015 are $- and for the year ended December
31, 2014 were $183,752 for Nicolette Consulting Group and $11,250 for DataSys Solutions.
Note 17 - Commitments
The Company leases its facility in West Deptford, New Jersey under an operating 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.
Under the terms of the lease, The Company will pay $132,000 per year.
Rent expense, including related CAM charges for the years ended December 31, 2015 and 2014 was $161,281 and
$161,245.
F-27
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
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 schedule of lease commitments is as follows:
Next 12 Months
Next 13-24 Months
Next 25-36 Months
Next 37-48 Months
Building
Equipment
Lease
Lease
$
132,000 $
132,000
132,000
132,000
6,156 $
6,156
6,156
5,130
Total
138,156
138,156
138,156
137,130
Note 18 - Major Customers
For the year ended December 31, 2015, two customers generated more than 10% of the Company’s revenue. Sales to
these customers accounted for 65% of the Company’s revenue. As of December 31, 2015, the amount due from these
customers was $435,261. This concentration makes the Company vulnerable to a near-term severe impact should the
relationships be terminated.
For the year ended December 31, 2014, four customers generated more than 10% of the Company’s revenue. Sales to
these customers accounted for 85% of the Company’s revenue. As of December 31, 2014, the amount due from these
customers was $3,406,026 of which $1,475,766 is a note receivable (Note 6). This concentration makes the Company
vulnerable to a near-term severe impact should the relationships be terminated.
Note 19 - Major Suppliers
For the year ended December 31, 2015, three suppliers accounted for more than 10% of the Company’s purchases.
These suppliers accounted for 41% of the Company’s total purchases. As of December 31, 2015, the amount due to
these suppliers was $16,317. This makes the Company vulnerable to a near-term severe impact should the relationships
be terminated.
For the year ended December 31, 2014, one supplier accounted for more than 10% of the Company’s purchases. This
supplier accounted for 17% of the Company’s total purchases. As of December 31, 2014, the amount due to the supplier
was $11,880. This makes the Company vulnerable to a near-term severe impact should the relationships be terminated.
Note 20 - Contingencies
On April 23, 2015, a complaint was filed by the Company in federal district court (District of New Jersey) against
ChubeWorkx Guernsey Limited (“ChubeWorkx”) for breach of contract (the “Breach of Contract Claim”) for failure of
timely interest payments by ChubeWorkx under a promissory note (the “Chube Note”) entered into by the Company and
ChubeWorkx in December 2014. As part of this action, the Company also filed a preliminary injunction which sought to
bar ChubeWorkx from disposing of the Company’s common stock owned by ChubeWorkx for which the Company
retained a right of sale in the event of a default by ChubeWorkx under the Chube Note. A consent decree has been
finalized and entered by the court to resolve the issues of the preliminary injunction which requires ChubeWorkx to
escrow a certain of number of shares of the Company’s common stock currently held by ChubeWorkx until the Breach
of Contract Claim has been fully adjudicated. The Breach of Contract Claim is currently in the discovery phase and
while the parties have communicated in good faith to resolve this dispute all discussions to date have not yielded any
results. This case was closed by the court pursuant to an order entered on December 22, 2015 as requested by Akers in
light of near final settlement discussions with Chubeworks regarding the settlement and release of all claims between the
parties. The settlement discussions were terminated on March 24, 2016 after substantial good faith efforts by the
Company to bring this dispute to a resolution. Under the Federal Rules of Civil Procedure the Company will seek to
reopen the case under Fed. R. Civ P. 60(b)(1) and prosecute this case with full vigor to retrieve the monies owed to the
Company.
F-28
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
AKERS BIOSCIENCES, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
On August 21, 2015, Chubeworkx filed a lawsuit against the Company in The High Court of Justice, Queen’s Bench
Division Commercial Court, Royal Courts of Justice, United Kingdom, alleging a breach of contract under the exclusive
license agreement entered into by Chubeworkx with Company in June 2012 and damages resulting from said alleged
breach. The lawsuit is in the preliminary stage and was suspended by mutual agreement of the parties pursuant to
ongoing global settlement discussions which were focused on settling all outstanding claims between the parties. The
settlement discussions were terminated on March 24, 2016. As a result, the Company will now proceed to defend this
suit with extreme vigor to minimize or eliminate any damages to the Company.
The Company and ChubeWorkx are actively discussing a global settlement for all existing claims and pending law suits.
As a reasonable estimate of any loss from this case cannot be made, no accrual for losses was made as of December 31,
2015.
Note 21 - Subsequent Events
On March 2, 2016, our Executive Chairman, Dr. Raymond Akers, Jr., Phd, entered into a Settlement Agreement with a
third party related to two pending lawsuits (the “Lawsuits”) filed by such third party against Dr. Akers (the “Settlement
Agreement”) in connection with a personal guarantee on a loan that was made in order to benefit the Company. Pursuant
to the terms of the Settlement Agreement, Dr. Akers is to pay the third party Two Hundred Fifty Five Thousand Dollars
($255,000) (the “Settlement Amount”) in consideration of the Lawsuits being dismissed with prejudice.
In accordance with the Company’s Amended and Restated Articles of Incorporation, the Board, upon conducting a
thorough analysis of the circumstances surrounding the Lawsuits, unanimously determined to indemnify Dr. Akers for
the Settlement Amount concluding that Dr. Akers, as an agent of the Company, ultimately acted in the best interests of
the Company and its shareholders.
The Company recognized the settlement as a material event as of December 31, 2015 and is reported as administrative
expenses in the consolidated statement of operations and comprehensive income for the year ended December 31, 2015.
F-29
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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
Exhibit 31.1
I, John Gormally., certify that:
1. I have reviewed this Form 10-K 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)
b)
c)
d)
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;
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;
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
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)
b)
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
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: March 30, 2016
By: /s/ John Gormally
John Gormally
Principal Executive Officer
Akers Biosciences, Inc.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
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
Exhibit 31.2
I, Raymond Akers Jr, certify that:
1. I have reviewed this Form 10-K 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)
b)
c)
d)
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;
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;
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
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)
b)
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
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: March 30, 2016
By: /s/ Raymond Akers Jr.
Raymond Akers Jr.
Principal Financial Officer
Akers Biosciences, Inc.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.1
In connection with this Annual Report of Akers Biosciences, Inc. (the “Company”), on Form 10-K for the fiscal year ended December
31, 2015, as filed with the U.S. Securities and Exchange Commission on the date hereof, I, John 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2015, 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2015, fairly presents, in
all material respects, the financial condition and results of operations of the Company.
Date: March 30, 2016
By: /s/ John Gormally
John Gormally
Principal Executive Officer
Akers Biosciences, Inc.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
Exhibit 32.2
In connection with this Annual Report of Akers Biosciences, Inc. (the “Company”), on Form 10-K for the fiscal year ended December
31, 2015, as filed with the U.S. Securities and Exchange Commission on the date hereof, I, Raymond Akers Jr., 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2015, 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2015, fairly presents, in
all material respects, the financial condition and results of operations of the Company.
Date: March 30, 2016
By: /s/ Raymond Akers Jr.
Raymond Akers Jr.
Principal Financial Officer
Akers Biosciences, Inc.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.
The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any
use of this information, except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.