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Akers Biosciences, Inc. Screening and testing technologies that deliver rapid health information to consumers and healthcare providers 1

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Page 1: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Akers Biosciences, Inc.Screening and testing technologies that deliver rapid health information to

consumers and healthcare providers

1

Page 2: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

All statements pertaining to future financial and/or operating results, future

growth in research, technology, clinical development, and potential opportunities

for Akers Biosciences, Inc. (Akers or the Company) products and services, along

with other statements about the future expectations, beliefs, goals, plans, or

prospects expressed by management constitute forward-looking statements.

Any statements that are not historical fact (including, but not limited, to

statements that contain words such as "will," "believes," "plans," "anticipates,"

"expects," "estimates") should also be considered to be forward-looking

statements.

Forward-looking statements involve risks and uncertainties, including, without

limitation, risks inherent in the development and/or commercialization of

potential 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 recent

Form 10-K and other reports filed with the Securities and Exchange Commission

which are available for review at www.sec.gov.

Actual results may differ materially from the results anticipated in these forward-

looking statements and as such should be evaluated together with the many

uncertainties that affect the Company's business.

The Company disclaims any intent or obligation to update these forward-looking

statements.

2

Forward

Looking

Statements

Page 3: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

3

Cutting edge

technologies

that deliver

rapid health

information

Growing

Product Portfolio

Growing Sales and

Distribution Capability

Growing

Global Market

Five products launched and

commercialized

Robust pipeline will result in

eleven products in market by

end of 2016

Expanded US sales and

marketing organization

Distribution in 33 countries

JV in China

Point-of-care diagnostics

market to reach $27.5bn by

2018

Need for significant

healthcare cost savings is

driving demand for new point-

of-care tests

Page 4: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

• In Vitro Diagnostics (IVD) are tests that take place outside of the body

• Key factors driving IVD market growth:

– increasing demand for rapid and non-invasive diagnostics

– availability of more point-of-care tests

– aging population

4

Akers

addresses the

large and

growing global

IVD market

Largest IVD Markets

USA (47%)

Western Europe (31%)

Fastest Growing IVD Market

Asia Pacific (CAGR 11.3%)

The IVD market

outpaces

pharma industry

growth

Page 5: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

5

Impact of new

healthcare

insurance

system in US

More lives insured = more testing

12 million more Americans have gained coverage in 2015; 21

million more predicted in 2016

• Screening costs are now fully covered for these conditions:

• Cholesterol

• Diabetes

• Obesity

• Alcohol misuse

• Chlamydia

• Approximately 15% of all physician visits involve tests for one

of the above - Akers Bio is targeting each of these conditions

Page 6: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Traditional Testing

(ELISA)

PIFA-PLUSS®

(Akers Bio)

Equipment

and Process

CapEx requiredCommonly

outsourced

No CapEx

Performed in-houseSimple

Time to

Results1 to 3 DAYS turnaround Rapid – 10 MINUTE test Faster

Cost per Test (U.S.) $150 - $300 (U.S.) $110 - $125Better

Value

Significant

Related Costs

~ $1,000 to $3,000 pharmacy

costs

~ $2,000 to $6,000

extended length of hospital stay

None for 80%+

of patients

testing negative

Key

Value

Driver

6

Akers’ rapid

diagnostic

tests

transform

traditional

healthcare

testing

Example of Customer Value

Customer Value:

Potential to save a typical U.S. hospital well over $1 Million annually

There are 4 million tests for Heparin-induced thrombocytopenia every year in the U.S. alone using slower, traditional methods

Page 7: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Technology Platform DescriptionProduct

Example

MPC™ - Micro Particle

Catalyzed Biosensor

Permits the rapid determination of

biomarkers in breath condensate

PIFA® - Particle

ImmunoFiltration Assay

Selective filtration of microparticles

in response to antibody / antigen

binding

REA ™ - Rapid Enzymatic

Assay

Detection of blood and urine

metabolites through enzymatic

chemistries in quantitative or semi-

quantitative formats

seraSTAT®Rapid production of Serum from

Whole Blood in minutes through the

use of membrane technology

SMC ™ - Synthetic

Macrocycle Complex

Novel organic macrocyclic

compounds and electronic readers

determine quantitative levels of

therapeutic drugs

Not yet commercialized

minDNAAnalysis of DNA in one minute using

a hand-held readerNot yet commercialized

6 proprietary

technology

platforms

provide the

foundation

for product

development

and external

licensing

7

Page 8: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Overview of Selected Commercialized Products

8

Page 9: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Market

Opportuni

ty

4 million HIT tests conducted annually in the U.S. alone – all of which could be

replaced with Akers’ PIFA test

Usage

Results within 10 minutes vs. 24-72 hours for outsourced lab results

Reduces unnecessary costs incurred with standard protocols, saving a typical U.S.

hospital > $1 Million per year

Status Selling

Sales

Channels

To hospitals and clinics via:

• Leading U.S. medical device distributors

• Direct sales force

• Telesales partner

• Internationally via in-country distribution partners

9

The only rapid

test to detect a

potentially fatal

allergy (HIT) to

the blood

thinner Heparin

HIT = Heparin-Induced Thrombocytopenia

Page 10: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

10

Akers Wellness

LyncTM

New,

personalized

approach to

informing the

current Health &

Wellness of an

individual

Market

Opportunity

Antioxidants and weight loss products - multi-billion dollar markets.

Akers Wellness products provide valuable health information in a consumer-

friendly format

Usage

Akers Wellness LyncTM – app-enabled, multi-device reader, providing easy,

quantified personal health information

KetoCheck – Breath-based device providing rapid, non-invasive identification of

optimal fat-burning state for weight loss (nutritional ketosis)

OxiCheck – Breath-based device providing rapid, non-invasive determination of

free radical levels and the efficacy of antioxidant supplementation

Metron - first generation of KetoCheck, visual read without LyncTM

Status

METRON - selling on amazon.com and akersbio.com

Akers Wellness LyncTM system– available Q4 2015

Sales

Channels

Distribution model

• Multi-level marketing organizations

• Weight loss centers

• Health and fitness clubs

• Anti-aging physicians

Page 11: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

11

Further

products

generating

revenues now

in high margin

markets

Tri-Cholesterol “Check”BreathScan® alcohol

detector

The only combined rapid test for

Total, HDL and LDL cholesterol

The only portable, disposable

alcohol breathalyzer in the US

Page 12: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Overview of Selected Pipeline Products

12

Page 13: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Market

Size

LUNG CANCER: > 1.6 million people worldwide diagnosed annually

ASTHMA: 300 million people worldwide diagnosed; prevalence up to 18%

COPD: 210 million people currently in treatment; up to 1 billion smokers at risk

Usage

Single-use, non-invasive device for pulmonary health screenings with the capacity

to dramatically change the speed and cost of diagnosing major respiratory

conditions

Status In commercial development

Next

Steps

File 510(k) for FDA clearance. In order of filing: Asthma, COPD, Lung Cancer

Seek distribution as companion diagnostics with prescription medicines; partner

with primary care-based diagnostic sales organizations and distributors that

market to retail health clinics

13

Breath

PulmoHealth

Breath tests for

biomarkers

indicating Lung

Cancer, Asthma

and COPD

Page 14: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Our rapid tests replace current testing methods

14

Multiple rapid

tests are being

developed in

large

diagnostic

markets

• Chlamydia test

• Diabetic ketoacidosis breath test

• Asthma breath test

• Lung cancer breath test

• Chronic Obstructive Pulmonary Disease

breath test

• Malaria test

• Dengue Fever test

• Heart attack test

2016 Launch 2017 Launch

Page 15: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

9M 2015 FY 2014

• Revenues: $1,646,443 $4,427,174

• Gross Profit: $901,124 $3,251,942

• Profit Before Tax: $(5,743,921)* $(3,127,167)

• Earnings Per Share: $(1.12) $(0.66) Revenues on

an upward

trend

15

FY 2012 FY 2013 FY 2014

$1.5m

$3.6m

$4.4m

*of which approximately $2.4m is non-recurring (approximately $1.3m is non-cash)

Page 16: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

As at

Sep 30, 2015 Dec 31, 2014

Cash & Marketable Securities$5,622,597 $9,720,802

Total Assets$11,054,522 $16,650,872

Total Liabilities$1,256,293 $1,843,986

Total Equity $9,798,229 $14,806,886

16

A strong

balance sheet

gives Akers the

resources

to develop and

grow

Page 17: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Raymond F. Akers, Jr. Ph.D. John J. Gormally

Founder, Executive Chairman of the Board Chief Executive Officer

30+ years in medical diagnostics; founded Akers in 1989

Invented most of Akers’ products and technologies; holds numerous patents

Ph.D. in Neurochemistry, Northwestern University

30 years with global medical technology company

Becton Dickinson.

Considerable experience of managing large

distribution networks as well as direct sales to

hospitals and reference laboratories.

Has led global sales functions with up to 250

associates and $1.1 billion in revenues.

17

Experienced,

focused

executive team

Christopher Ellis

Vice President, Global Marketing

Led provider marketing for Vree Health, LLC, a subsidiary of Merck, one of the largest pharmaceutical companies in the world

12 years in various positions of increasing responsibility within sales and marketing at Merck

John C. Cheneval Nicolas Daurel

Senior Vice President, Sales and Marketing Vice President, Sales and Marketing, EMEA

25+ years high level industry experience including within Johnson & Johnson, Novartis Molecular Diagnostics and Genoptix Medical Labs

Recognized leader in commercializing diagnostic products in healthcare sector

Responsible for launch and management of several hundred million dollars of diagnostic product sales

20+ years experience in international sales

Held similar positions with Trinity Biotech plc, Diagnositica Stago, SA, Roche Diagnostics

.

Page 18: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Gary M. Rauch George J. Awad

Vice President, Finance Director, Corporate & Legal Affairs

35+ years in accounting, information systems, and operations consulting

Engagements in healthcare, manufacturing and distribution

Registered patent attorney with 18+ years corporate/IP legal/corporate development experience.

Specialization in developing, driving, and deploying full cycle commercialization/growth plans across various technology industries.

Richard E. McKee Adam C. Sobel M.D.

Vice President, Engineering Director, Medical

40+ years in product design, development and consulting for automated manufacturing equipment in medical diagnostics, pharmaceuticals, food, glass, and automotive

Adjunct Professor of Engineering

MD, Internal Medicine, Jefferson Medical College, Philadelphia, PA

Responsibility for overseeing Akers’ clinical trials

Attending physician at Thomas Jefferson University Hospital, Pennsylvania Hospital, Methodist Hospital, Penn Medicine, Main Line Health System, Nazareth Hospital

Member, American Medical Association, American College of Physicians

18

Experienced,

focused

executive and

medical team

Page 19: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

19

Supported by

experienced

non-executive

directors

Thomas J. Knox Robert E. Andrews

Non-Executive Co-Chairman of the Board Non-Executive Director

Expertise in healthcare and finance

Former CEO of United Healthcare of Pennsylvania; Former Chairman of the Board and Chief Executive Officer of Fidelity Insurance Group, Inc.

Candidate for Mayor of Philadelphia (2007) and candidate for Governor of Pennsylvania (2010)

Member of the U.S. House of Representatives for nearly 24 years (New Jersey's 1st congressional district)

Served on Committees for Armed Services, Budget and Education and Labor (as chairman of the Subcommittee on Health, Employment, Labor, and Pensions)

Retired from the House in 2014 to take position as Of Counsel at Dilworth Paxson LLP where he also chairs Government Affairs Group

Brandon T. Knox Raza Bokhari M.D.

Non-Executive Director Non-Executive Director

Experience in corporate finance and financial management

Currently wealth advisor at Raymond James

Expertise in life sciences and healthcare businesses

Managing Partner of a private equity fund focused on investing in US laboratory testing market

Chairman/CEO of College of an American Pathologists accredited national CLIA–certified clinical reference laboratory

Page 20: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

Expand sales organization

Leverage costs savings

message

Expand international

distribution in key markets

Establish U.S. partnerships to

distribute Cholesterol tests

and Akers Wellness products

Diabetic ketoacidosis breath

test

Chlamydia test

Asthma breath test

Lung cancer breath test

COPD breath test

Heart attack test

Clear path to

grow value

1.

Enhance Sales

and Distribution

2.

Launch

New Rapid

Tests

3.

Develop

New Rapid

Tests

20

Page 21: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

21

Cutting edge

technologies

that deliver

rapid health

information

Growing

Product Portfolio

Growing Sales and

Distribution Capability

Growing

Global Market

Five products launched and

commercialized

Robust pipeline will result in

eleven products in market by

end of 2016

Expanded US sales and

marketing organization

Distribution in 33 countries

JV in China

Point-of-care diagnostics

market to reach $27.5bn by

2018

Need for significant

healthcare cost savings is

driving demand for new point-

of-care tests

Page 22: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/...2015/11/30  · growth in research, technology, clinical development, and potential opportunities for Akers Biosciences,

CONTACT

a: 201 Grove Road, Thorofare, N.J. 08086, USA

t: +1 (856) 848 8698 e: [email protected] tw: @AkersBio

www.akersbio.com