Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/... · 2018-11-02 · limitation, risks...

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

Transcript of Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/... · 2018-11-02 · limitation, risks...

Page 1: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/... · 2018-11-02 · limitation, risks inherent in the development and/or commercialization of potential products, uncertainty

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/... · 2018-11-02 · limitation, risks inherent in the development and/or commercialization of potential products, uncertainty

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

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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

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• 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

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Impact of new

healthcare

insurance

system in US

More lives insured = more testing

12 million more Americans 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

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Traditional Testing

(ELISA)

PIFA-PLUSS®

(Akers Bio)

Equipment

and Process

CapEx required Commonly

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 US.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

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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

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Overview of Selected Commercialized Products

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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

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The only rapid

test to detect a

potentially fatal

allergy (HIT) to

the blood

thinner Heparin

HIT = Heparin-Induced Thrombocytopenia

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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

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Akers

Wellness app

The LyncTM

device syncs

via the Akers

Wellness app

on any mobile

or tablet

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Akers

Wellness app

The app

allows the

user to track

and monitor

his/her

health over

time

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Akers

Wellness app

The app gives

personalized

advice based

on the user’s

score

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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

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Overview of Selected Pipeline Products

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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

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Breath

PulmoHealth

Breath tests for

biomarkers

indicating Lung

Cancer, Asthma

and COPD

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Our rapid tests replace current testing methods

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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

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Q1 2016 FY 2015

• Revenues: $738,023 $2,115,050

• Gross Profit: $537,995 $1,164,258

• Profit Before Tax: $(1,500,395) $(9,311,913)*

• Earnings Per Share: $(0.28) $(1.81) 2016 set to

materially

outperform

2015

18

$4.4m

*non-cash and non-

recurring items totalled

approximately $4.7

million

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As at

Dec 31, 2015 Dec 31, 2014

Cash & Marketable Securities$4,427,163 $9,720,802

Total Assets$8,271,909 $16,650,872

Total Liabilities$1,668,731 $1,843,986

Total Equity $6,603,178 $14,806,886

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A strong

balance sheet

gives Akers the

resources

to develop and

grow

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

Founder, Chief Scientific Director 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.

20

Experienced,

focused

executive team

Nicolas Daurel Douglas Carrara

Vice President, Sales and Marketing, EMEA Vice President, Global Marketing & Commercial Ops

20+ years experience in international sales

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

.

25 years’ experience in sales, marketing and global operations in linical diagnostics

Held similar positions with Quest Diagnostics and Becton Dickinson

Tony Saporito Gary M. Rauch

Vice President, US Sales and Distribution Vice President, Finance

20+ years experience in diagnostics sale

Held similar positions with Midmark Corp. and Convatec, a division of Bristol Meyers Squibb

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

Engagements in healthcare, manufacturing and distribution

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Expand sales organization

Leverage costs savings

message

Expand international

distribution in key markets

Establish US 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

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22

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 23: Akers Biosciences, Inc./media/Files/A/Akers-Biosciences/... · 2018-11-02 · limitation, risks inherent in the development and/or commercialization of potential products, uncertainty

CONTACT

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

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

www.akersbio.com