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March 28, 2014
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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 | NASDAQ: AKER | LSE: AKR
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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)
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COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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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”
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
Asthma: > 300 m living with / year COPD: 1 b smokers at risk
Lung Cancer: >1.6 m diagnosed / year
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COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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%
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FoundaSon: Pla^orm Technologies
Micro ParScle Catalyzed (MPC™)
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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
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COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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%
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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≥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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
Significant correlaSon between Breath Ketone levels and Blood Ketone levels
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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
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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
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• 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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
STAT Point-‐of-‐Care
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
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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
COPYRIGHT® 2013 | NASDAQ: AKER | LSE: AKR
$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
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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%
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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
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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
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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
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Comp Set
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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
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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