07 aker

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.

COPYRIGHT®
2013

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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

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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2013

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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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Asthma:
>
300
m
living
with
/
year

COPD:
1
b
smokers
at
risk

Lung
Cancer:
>1.6
m
diagnosed
/
year

6

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2013

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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

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

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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

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

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

≥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

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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

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

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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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

•  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

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

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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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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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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$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

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

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

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

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

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

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

07 aker

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