This document discusses forward-looking statements and risks for Akers Biosciences, Inc. It notes that any statements regarding future financial performance, development of products and services, or opportunities should be considered forward-looking. Actual results may differ due to risks in development, clinical trials, need for capital, and intellectual property maintenance. The document also provides brief biographies of ABI's experienced management team and board.
2. 2
Forward
Looking
Statements
All
statements
pertaining
to
future
financial
and/or
opera5ng
results,
future
growth
in
research,
technology,
clinical
development,
and
poten5al
opportuni5es
for
Akers
Biosciences,
Inc.
(ABI
or
the
Company)
products
and
services,
along
with
other
statements
about
the
future
expecta5ons,
beliefs,
goals,
plans,
or
prospects
expressed
by
management
cons5tute
forward-‐looking
statements.
Any
statements
that
are
not
historical
fact
(including,
but
not
limited,
to
statements
that
contain
words
such
as
"will,"
"believes,"
"plans,"
"an5cipates,"
"expects,"
"es5mates")
should
also
be
considered
to
be
forward-‐looking
statements.
Forward-‐looking
statements
involve
risks
and
uncertain5es,
including,
without
limita5on,
risks
inherent
in
the
development
and/or
commercializa5on
of
poten5al
products,
uncertainty
in
the
results
of
clinical
trials
or
regulatory
approvals,
need
and
ability
to
obtain
future
capital,
and
maintenance
of
intellectual
property
rights
and
other
risks
discussed
in
the
Company’s
registra5on
statement
on
Form
S-‐1
and
other
reports
filed
with
the
Securi5es
and
Exchange
Commission
which
is
available
for
review
at
www.sec.gov.
Actual
results
may
differ
materially
from
the
results
an5cipated
in
these
forward-‐looking
statements
and
as
such
should
be
evaluated
together
with
the
many
uncertain5es
that
affect
the
Company's
business.
The
Company
disclaims
any
intent
or
obliga5on
to
update
these
forward-‐looking
statements.
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3. 3
Experienced,
Focused
Management
and
Board
Raymond
F.
Akers,
Jr.
Ph.D.
Founder,
Execu-ve
Chairman
of
the
Board
(Director)
• 30+
years
in
medical
diagnosGcs;
founded
ABI
in
1989
• Invented
most
of
ABI’s
products
and
technologies;
numerous
patents
• Ph.D.
in
Neurochemistry,
Northwestern
University
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Edwin
C.
Hendrick
Execu-ve
Vice
President,
Sales
and
Marke-ng
• 25
year
career
in
healthcare
leading
the
commercial
aspects
of
diagnosGc
and
healthcare
services
companies
ranging
in
size
from
$10
million
to
$1
billion
in
revenues;
joined
ABI
in
2014
• Most
recent
engagements
include
execuGve
posiGons
with
PLUS
DiagnosGcs
,
US
Labs
and
Ventana
Medical
Systems
Patrice
Laterra
McMorrow
Vice
President,
Marke-ng
• 20+
years
in
sales
and
markeGng
in
diagnosGcs,
pharmaceuGcal,
and
ophthalmic
industries;
joined
ABI
in
2004
• Competencies:
new
product
launches,
sales
operaGons,
and
distribuGon
management
Officers
&
Key
Management
Team
Gary
M.
Rauch
Vice
President,
Finance
• 35+
years
in
accounGng,
informaGon
systems,
and
operaGons
consulGng,
joined
ABI
in
2010
• Engagements
in
healthcare,
manufacturing
and
distribuGon
Non-‐Execu5ve
Directors
Gavin
E.D.
Moran
Appointed
July
2013
• Extensive
experience
in
trading,
finance
and
markeGng
• Trading
roles
at
Shell
InternaGonal,
Trafigura
Ltd,
and
since
April
2010,
beneficial
shareholder
at
Sono
InternaGonal
Ltd
Thomas
J.
Knox
Appointed
July
2013
• ExperGse
in
health
care
and
finance
• Former
CEO
of
United
Healthcare
of
Pennsylvania;
Former
Chairman
of
the
Board
and
Chief
ExecuGve
Officer
of
Fidelity
Insurance
Group,
Inc.
• Currently
Chief
ExecuGve
Officer
of
Knox
ConsulGng
Group,
Chairman
of
ORB
AutomoGve
CorporaGon,
Ltd.
Brandon
T.
Knox
Appointment
January
2014
• Experience
incorporate
finance
and
financial
management
• Currently
wealth
advisor
at
Raymond
James
4. Overview
• ABI
develops,
manufactures
and
supplies
rapid
diagnosGc
tests
for
hospital
laboratories,
government,
military,
law
enforcement,
on-‐the-‐job
safety,
doctors’
offices
and
home
use
• Four
of
ABI’s
six
proprietary
plagorm
technologies
have
lead
to
the
development
of
11
core
products,
each
with
mass
market
potenGal
• Sales
and
distribuGon
though
blue
chip
medical
products
companies
• Core
Strategy:
IdenGfy
high
margin
market
segments
with
inadequate
tesGng
soluGons
and
introduce
ABI’s
rapid
alternaGve
• Underpinned
by
valuable
proprietary
plagorm
technology
base
• 10
UGlity
&
6
Design
patents
granted
in
force;
10
UGlity
patent
applicaGons
pending
• Manufacturing
facility
approved
by
FDA
(GMP),
LNE
(French
NF
X20-‐720
Standard),
SAI
Global
(Australian
AS
3547-‐1997
Standard)
• Registered
US
Government
Contractor
(GSA
contract
GS-‐07F-‐0140W)
• 2013
revenues
increased
by
129%
to
$3.6
million
(2012:
$1.6
million)
4
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5. 5
New
healthcare
environment
drives
cost-‐containment
and
the
need
for
rapid,
point-‐of-‐care
diagnosSc
tesSng
soluSons
that
are…
• Fast
• Affordable
• Accurate
• Flexible
• Simple-‐to-‐perform
• Early
diagnosis
Global
IVD
Market
EsSmated
at
$45
Billion;
Expected
to
Reach
$64
Billion
in
2017
June
6,
2013
-‐
Frost
&
Sullivan
“Global
In
Vitro
Diagnos5cs
Markets
Outpace
Pharma
Industry
Growth”
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6. Asthma:
>
300
m
living
with
/
year
COPD:
1
b
smokers
at
risk
Lung
Cancer:
>1.6
m
diagnosed
/
year
6
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Global
Target
Market
StaSsScs
by
Technology
Pla^orm
28.5
million
Type-‐1
diabe5cs
MPC™
Health
and
wellness
segment
“emerging
trillion
dollar
market”
Infec5ous
diseases
account
for
more
than
15
million
deaths/year;
25
million
pa5ents
receive
heparin/year
Cardiovascular
disease:
>17
m
deaths/year
WHO
es5mates
80%
in
emerging
countries
REA®
PIFA®
Annual
growth
of
global
breathalyzer
market
≈
26%
7. 7
FoundaSon:
Pla^orm
Technologies
Micro
ParScle
Catalyzed
(MPC™)
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Permits
the
rapid
determina5on
of
biomarkers
in
breath
condensate
ParScle
ImmunoFiltraSon
Assay
(PIFA®)
Based
on
the
selec5ve
filtra5on
of
micropar5cles
in
response
to
an5body/an5gen
binding
Rapid
EnzymaSc
Assay
(REA
™)
Detec5on
of
blood
and
urine
metabolites
through
enzyma5c
chemistries
in
quan5ta5ve
or
semi-‐
quan5ta5ve
formats
seraSTAT®
Rapid
produc5on
of
Serum
from
Whole
Blood
in
minutes
through
the
use
of
membrane
technology
minDNA
Allows
for
the
analysis
of
DNA
in
one
minute
using
a
hand-‐held
reader
SyntheSc
Macrocycle
Complex
(SMC
™)
Novel
organic
macrocyclic
compounds
and
electronic
readers
determine
quan5ta5ve
levels
of
therapeu5c
drugs
:
Technology
currently
u5lized
in
commercialized
products
Biosensor
8. 8
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Research
&
Discovery
Clinical
Development
Commercial
Development
Launch
&
Market
Entry
Asthma
COPD*
Lung
Cancer
*Chronic
Obstruc5ve
Pulmonary
Disorder
5
MPC™
Products
Commercialized
and
4
in
Clinical/Commercial
Development
Diabe5c
Ketoacidosis
9. Disposable
Alcohol
Breathalyzers
Cut-‐off
levels:
.02%;
.04%;
.05%;
.08%
9
CerSficaSons:
FDA-‐cleared,
French
(NF
X
20-‐702),
Australian
(AS
3547:1997)
• Only
known
US
manufacturer
and
one
of
two
manufacturers
worldwide
to
hold
cerGficaGons
• 2013
French
law
mandates
two
NF-‐marked
alcohol
breathalyzers
in
each
vehicle:
• 34
million
vehicles
registered
in
France;
15
million
entering
the
country
annually;
3
million
rentals;
6.5
million
commercial
vehicles
• Heightened
awareness
throughout
EU
–
Italy,
Netherlands
• Next
Steps:
• Co-‐branding
with
Industrial,
TransportaGon,
and
Alcoholic
Beverage
companies
• BE
CHUBE
Programs
related
to
personal
and
“buddy”
alcohol
safety:
SporGng
Events;
Colleges/UniversiGes;
Military
safety,
DUI-‐prevenGon
programs
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10.
10
Monitoring
of
Ketones
(acid)
for
diabe-c
health
• Type
1,
and
some
Type
2,
diabeGcs
are
at
risk
for
developing
ketoacidosis
• Ketoacidosis
is
suspected
when
glucose
levels
exceed
250mg/dl,
or
if
flu-‐like
symptoms
are
observed,
and
can
lead
to
organ
failure
or
loss
of
life
• Product
Benefits:
non-‐invasive,
immediate
result,
cost-‐effecGve,
bewer
alternaGve
to
invasive
blood
tests
and
inconvenient
urine
tests
• 28.5
million
Type
1
diabeGcs,
1+
tests/week
• Reduces
healthcare
costs
by
decreasing
the
need
for
hospital
visits
and
expensive
lab
tesGng
• Next
Steps:
• Submit
510(k)
filing
for
FDA
clearance
• IniGal
distribuGon
into
teaching
hospitals,
centers
of
excellence
and
diabetes
centers
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11. 11
≥1.5
mmol/L <
1.5
mmol/L
PosiSve 34 0
NegaSve 0 6
Forty
(40)
human
subjects
previously
diagnosed
with
diabetes
evaluated
by
the
qualitaGve
Breath
Ketone
“Check”
test
and
the
quanGtaGve
Precision
Xtra
meter
and
test
strips
for
blood
ketones.
Breath
Ketone
“Check”
test
turns
posiGve
if
blood
ketone
level
≥
1.5mmol/
L;
negaGve
<
1.5mmol/L.
DistribuGon
of
all
corresponding
paired
measurement
values
for
both
tesGng
methodologies:
Precision
Xtra
Findings:
The
DetecGon
Success
Rate
between
Precision
Xtra
and
Breath
Ketone
“Check”
was
100%.
Source:
Date
on
File
Clinical
Data
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Significant
correlaSon
between
Breath
Ketone
levels
and
Blood
Ketone
levels
12. 12
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Non-‐medical
measurement
of
ketone
produc-on
associated
with
desired
fat-‐burning
due
to
weight
loss
or
an
increase
in
exercise
• Immediate
market
entry
as
not
FDA-‐regulated
• Assists
in
developing
targeted
intervenGons
aimed
at
weight
loss
and
fitness
• Maximum
convenience
with
real-‐Gme
result
• Next
Steps:
• DistribuGon
opportuniGes
with
health
and
wellness
companies
specializing
in
mass
distribuGon
• Diet
plans
–
Atkins,
Nutrisystem,
South
Beach
• NutriGonal
supplement
suppliers
–
GNC,
Vitamin
Shoppe,
The
Vitamin
Company
• MulG-‐level
MarkeGng
–
Amway,
Isagenix,
Arbonne
• Weight
Loss
regimens
/
bariatric
surgery
paGents
13.
13
Non-‐invasive,
quan-ta-ve
measurement
of
biological
markers
for
oxida-ve
stress
that
relates
to
cellular
damage
• Only
non-‐invasive
breath
test
with
disposable
reagents
and
photometric
device
• Immediate
result
indicates
current
levels
of
free
radicals
in
system
• Companion
test
to
nutriGonal
supplementaGon
and
exercise
regimens
targeted
to
control
free
radicals
and
oxidaGve
stress
• OxidaGve
stress
implicated
in
several
disease
processes
(e.g.
cardiovascular
disease,
cancer,
arthriGs)
• Next
Steps:
• DistribuGon
through
health-‐related
mulGlevel
markeGng
organizaGons
and
nutriGonal
supplement
suppliers
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14.
14
Breath
tests
for
biomarkers
indica-ng
Asthma,
COPD,
&
Lung
Cancer
• Only
single-‐use,
non-‐invasive
device
for
pulmonary
health
screenings
• ASTHMA:
Up
to
15%
of
a
country’s
populaGon
may
have
Asthma
• COPD:
1
billion
smokers
at
risk
for
COPD
• LUNG
CANCER:
>
1.6
million
people
diagnosed
each
year
• Reduces
costs
associated
with
diagnosGc
imaging
and
pulmonary
funcGon
tests
• Companion
diagnosGc
tests
to
assess
compliance
/
effecGveness
of
therapeuGc
agents
• Next
Steps:
• File
510(k)
for
FDA
clearance,
in
order
of
filing:
Asthma,
COPD,
Lung
Cancer
• Seek
distribuGon
as
companion
diagnosGcs
with
prescripGon
medicines;
partner
with
primary
care-‐based
diagnosGc
sales
organizaGons
and
distributors
that
market
to
retail
health
clinics
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15. 15
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Research
&
Discovery
Clinical
Development
Commercial
Development
Launch
&
Market
Entry
4
PIFA®
Products
Commercialized
and
5
in
Clinical/Commercial
Development
HIV
1
+
2
Syphilis
Dengue
Fever
Hep
B
/
Hep
C
16.
16
• Rapid
Tests
for
Heparin/PF4
anGbodies
to
detect
a
potenGal
allergy
(HIT)
to
the
blood
thinner,
Heparin
• Heparin
is
the
most
widely
used
anGcoagulant;
indicated
for
most
surgeries,
dissoluGon
of
blood
clots
• HIT
is
a
life-‐
and
limb-‐threatening
“allergy”
to
heparin;
1-‐5%
HIT
incidence
in
cardiac
surgery
paGents;
Subsequent
risks:
Mortality:
30%,
Limb
AmputaGon:
20%
• Only
FDA
cleared
rapid
anGbody
tests
for
HIT-‐anGbody
assessment;
competes
with
expensive,
slow
turn-‐around
laboratory
tests
• Next
Steps:
• Complete
clinical
trial
for
SFDA
in
China
• Build
internaGonal
distribuGon;
expand
North
American
sales
support
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STAT
Point-‐of-‐Care
17. 17
ProspecSve
observaSonal
evaluaSon
of
the
parScle
immunofiltraSon
anS-‐
platelet
factor
4
rapid
assay
in
MICU
paSents
with
thrombocytopenia
David
M
Andrews,
Galo
F
Cubillos,
SarGa
K
Paulino,
Daniel
L
Seckinger
and
Daniel
H
Kew
Cri5cal
Care
2013,
17:R143
>99%
Nega-ve
Predic-ve
Value
(NPV)
Confirmatory
SRA
PosiSve
NegaSve
PIFA
PosiSve
2
26
PIFA
NegaSve
0
62
Conclusion:
PIFA
=
Rapid
HIT-‐An5body
Rule-‐Out
Test
NEGATIVE
PIFA
result
correlates
>99%
with
a
NEGATIVE
SRA
on
acceptable
samples
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18. 18
Chlamydia,
Malaria,
Dengue
Fever,
Hep
B,
Hep
C,
HIV
1
+
2,
Syphilis
InfecSous
Disease
Rapid
Assays
Rapid
tests
for
STDs,
Blood
borne
pathogens,
Tropical
Diseases
• Integrates
sample
processing
into
test
procedure
• Conducive
to
screenings
in
non-‐tradiGonal
or
remote
locaGons
• InfecGous
disease
market
large
and
growing
in
developing
world
• Chlamydia
test
will
be
the
first
test
to
use
finger
sGck
whole
blood
as
specimen;
current
tests
used
genital
swabs
and
DNA-‐based
assays
• Next
Steps:
• File
510(k)
for
Chlamydia
test
• Expand
distribuGon
into
developing
world,
including
internaGonal
aid
organizaGons
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19. 19
Prepares
whole
blood
specimen
for
introduc-on
into
an
assay
device
in
minutes
to
facilitate
immediate
tes-ng
any-me,
anywhere.
• Rapid
blood
cell
separator
facilitates
immediate
tesGng
with
a
small
volume
of
fresh
whole
blood
• Procedure
can
be
iniGated
by
finger
sGck
blood
sample
• FDA-‐Cleared
• Already
integrated
into
PIFA
PLUSS
PF4
device
and
in
emerging
PIFA
InfecGous
Disease
products
• Next
Step:
Market
as
a
stand-‐alone,
OEM
device
to
outside
IVD
manufacturers
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20. 20
Only
combined
rapid
test
for
Total
and
HDL
cholesterol
and
es-mates
LDL
• Semi-‐quanGtaGve
• Rapid
results
from
convenient
finger
sGck
sample
• Useful
for
home
tesGng,
mass
screenings,
remote
locaGons
• 3
Minute
test
• Next
Step:
Penetrate
developing
world
market
where
laboratory
infrastructure
not
yet
established
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21. $0
$1,000,000
$2,000,000
$3,000,000
$4,000,000
2012
2013
Revenues
0%
20%
40%
60%
2012
2013
Gross
Profit
Margin
21
Commimed
to
Growth
of
Shareholder
Value
!
2013
revenues
increased
by
129%
to
$3.6
million
(2012:
$1.6
million)
! Gross
Profit
Margin:
47%
(2012:
36%)
! Gross
profit
increased
199%
year-‐over-‐year
to
$1.7
million
(2012:
$560k)
! Net
Loss
A{er
Tax
Benefit
reduced
to
$1.5
million
(2012
loss:
$2.6
million)
! EBITDA:
loss
$1.2
million
(2012
loss:
$2.4
million)
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
• Drive
internaGonal
sales
and
markeGng
of
CHUBE
• Expand
domesGc
and
internaGonal
distribuGon
of
PIFA
PF4
rapid
assays
• Grow
US
distribuGon
of
METRON
and
VIVO
• Product
launches:
Breath
Ketone
“Check”,
PIFA
InfecGous
Disease
assays,
Breath
PulmoHealth
“Check”
-‐
Asthma
Recent
Future
30%
129%
22. 22
Profit
and
Loss
Fiscal
Year
Ending
Dec
31
2013
2012
Revenue
3,577,851
1,564,101
Gross
Profit
1,664,007
556,150
AdministraSve
Expenses
1,524,626
1,493,707
Sales
&
MarkeSng
Expenses
684,720
638,732
Research
&
Development
Expenses
1,006,800
900,380
OperaSng
Profit
(1,526,773)
(2,725,228)
Net
Profit
(1,526,773)
(2,557,820)
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
23. 23
Balance
Sheet
Overview
As
of
Dec
31,
2013
Dec
31,
2012
Total
Assets
6,075,622
5,417,291
Total
LiabiliSes
1,953,388
2,113,268
Total
Equity
4,122,234
3,304,023
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
24. 24
CapitalizaSon
Structure
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
As
of
Mar
25,
2014
Shares
Common
Stock
1,596,722
Warrants
–
Average
Exercise
Price
of
$71.76
1,989
Total
-‐
Fully
Diluted
1,598,711
25. Company
Symbol
Company
Overview
Market
Cap
As
of
12/30/13
Meridian
BioScience
Inc.
VIVO
manufactures,
markets
and
distributes
diagnosGc
test
kits,
purified
reagents
and
biopharmaceuGcals
$
1,105M
Quidel
CorporaGon
QDEL
develops,
manufactures
and
markets
rapid
diagnosGc
tesGng
soluGons
$
972M
ChemBio
DiagnosGcs,
Inc.
CEMI
develops,
manufactures,
licenses
and
markets
point-‐of-‐
care
(POC)
diagnosGc
tests
$
31M
OraSure
Technologies,
Inc.
OSUR
develops,
manufactures,
and
markets
oral
fluid
diagnosGc
products
and
specimen
collecGon
devices
$
336M
TrovaGene,
Inc.
TROV
develops
rapid,
non-‐invasive
molecular
diagnosGc
assays
$
109M
Venaxis,
Inc.
APPY
develops
and
commercializes
in
vitro
diagnosGc
mulG-‐
biomarker
diagnosGc
test
$
45M
25
Comp
Set
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
26. 26
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
Asthma
COPD*
*Chronic
Obstruc5ve
Pulmonary
Disorder
Product
Summary
Diabe5c
Ketoacidosis
Commercial
Development
Clinical
Development
Launch
&
Market
Entry
Hep
B
/
Hep
C
HIV
1
+
2
Lung
Cancer
Syphilis
Dengue
Fever
27. 27
Summary
COPYRIGHT®
2013
|
NASDAQ:
AKER
|
LSE:
AKR
• New
healthcare
environment
drives
cost-‐containment
and
the
need
for
point-‐of-‐care
diagnosSc
soluSons
• Six
proprietary
pla^orm
technologies
enable
rapid,
cost-‐efficient
new
product
launches
• MulSple
products
already
commercialized
• Robust
new
product
pipeline
• AcceleraSng
growth
drives
value
proposiSon
for
investors