February 2012. Forward-looking Statements Information contained in this presentation may contain...
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Transcript of February 2012. Forward-looking Statements Information contained in this presentation may contain...
February 2012
Forward-looking Statements
Information contained in this presentation may contain forward-looking statements, including, but not limited to: the expectation that Easy Check and GlucoChip will eliminate the patient’s need to prick his/her finger multiple times per day, the expectation that GlucoChip will have a one-year life span, that the product launch of iglucose is expected by early 2012, and the development timeline provided for iglucose, Easy Check and GlucoChip. These forward-looking statements are not statements of historical fact and represent only PositiveID Corporation's beliefs regarding future performance, which is inherently uncertain. There are a variety of factors, many of which are beyond the control of PositiveID Corporation, which affect operations, performance, business strategy and results and could cause actual results and experience to differ materially from the expectations and objectives expressed in any forward-looking statements. Additional information about these and other factors that could affect PositiveID Corporation's business is set forth in PositiveID Corporation's various filings with the Securities and Exchange Commission, including those set forth in PositiveID Corporation's Form 10-K filed on March 25, 2011, and Forms 10-Q filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption “Risk Factors.” PositiveID Corporation undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
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Key Facts
Symbol OTCBB: PSID
Corporate Headquarters Delray Beach, FL
Stock Price (2/1/12) || 52-Week Range $0.14 || $0.12-$0.74
Shares Outstanding 80,381,659
Market Cap $7.9M
Volume (Daily 90-Day Average) 271,916
Long-Term Debt (9/30/11) $0.00
Full-Time Employees 18
Fiscal Year December 31
Accounting Firm EisnerAmper LLP
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PositiveID Summary
PositiveID Corporation develops unique medical devices and molecular diagnostic systems, focused primarily on diabetes management, rapid medical testing and airborne bio-threat detection products.
It’s key products are: iglucose – automatic wireless communication of blood sugar
readings Easy Check – non-invasive breath detection of glucose levels GlucoChip – implantable RFID glucose-sensing microchip M-BAND – sample processing and detection of airborne bio-
threats Dragonfly – disposable cartridge for biological sample
processing and detection (rapid PCR) for biodefense and clinical applications
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Easy-to-use, patent-pending wireless device that connects and communicates automatically from existing data-capable glucometers FDA clearance received November 2011
Collects, records and transmits a patient’s blood glucose data from a glucometer to the iglucose online database
iglucose correlates data and sends glucose readings via text message, email or fax to family member, caregiver, physician or other designee
Integrated iglucometer with “iglucose inside” prototype complete; combines FDA-cleared glucometer technology with iglucose communication platform
Global market for glucometers and strips is forecast to reach $18B by 2015*
Three-year wireless communication agreement with AT&T Wireless communication agreement with Rogers Wireless and CanCare
to launch in Canada Commitment to purchase a minimum of 28,000 units
TM
5*Source: Global Industry Analysts’ “Blood Glucose Meters and Strips: A Global Strategic Business Report,” October 2010
iglucose Market OpportunityAssumptions
• Total market size equals 25 million diabetics in the U.S.
• End user sale price of $90 device• Monthly subscription of $10 (annualized $120)• Strip sales - $0.05 per strip per reading, @ three
readings/dayAssumptions
Timeline
• 510(k) clearance received Nov. 2011• Commercial launch expected in Q1 2012
Total annual market size for device sales
Total annual market size for monthly subscription
Total annual market size for strip sales
5% 10% 25% 50%Market penetration*
$150 $300
$750
$1,500
5% 10% 25% 50%Market penetration*
5% 10% 25% 50%Market penetration*
$113 $225
$563
$1,125
$68 $137
$342
$684
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(Device sales and recurring revenue in $ millions on annual basis)
Easy Check™ breath glucose detection device, under development, is a non-invasive glucose detection system that measures acetone levels in a patient’s exhaled breath
The association between acetone levels in the breath and glucose is well documented
A handheld, battery-operated, portable, easy-to-use device that includes:
Advanced laser optical sensor, state-of-the-art microprocessor, patent-pending chemical sensors
The goal: patient exhales into the device to test glucose levels without the sample of blood presently required by existing glucometers
Utilizes single-use capsule containing proprietary sodium nitroprusside-based reagent that triggers a chemical reaction that is be measured and correlated to glucose levels
Preliminary lab tests reveal positive results within industry standards for glucometers as set by the National Committee of Clinical Laboratory Standards (currently Clinical and Laboratory Standards Institute – NCCL) and the International Organization for Standardization (ISO)
Could eliminate a patient’s need to prick his/her finger multiple times a day to get glucose readings
Patent pending
Easy Check Breath Device
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Easy Check Market Opportunity
Assumptions
• Total market size equals 25 million diabetics in the U.S.
• End user sale price of $100 device• Replaceable single-use cartridge at $1.00 each
• Five readings/day = over 1,800 readings/year(Device sales and recurring revenue in $ millions on annual basis)
Timeline
• Multi-variable/sensitivity testing through 2011
• Clinical studies to commence by YE 2011 through 2012
• Commercial prototype development in 2012
Annual recurring revenue @ one reading/day
Total annual market size for device sales
Annual recurring revenue @ five readings/day
$125 $250
$625
$1,250
5% 10% 25% 50%Market penetration*
5% 10% 25% 50%
Market penetration*
5% 10% 25% 50%Market penetration*
*Does not include any assumption of growth in diabetic market.
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$456 $913
$2,281
$4,563
$2,281 $4,563
$11,406
$22,813
Glucose-Sensing Microchip (GlucoChip) From our historical base with the original VeriChip – the shift from
identification to diagnostic In vivo glucose-sensing RFID microchip, the GlucoChip™, based on
PositiveID’s Patent No. 7,125,382 for Embedded Bio-Sensor System and Receptors’ patented CARA™ platform Filed additional utility patent covering the interface between an RF powered
resonant electromechanical drive and the fluids in the interstitial space of a patient for continuous detection of glucose levels in a patient
GlucoChip will lie completely under the skin to provide continuous glucose sensing; communicates glucose levels to an external scanner
Phase II development completed – successfully created a stable, reproducible glucose-sensing system and filed related patent
GlucoChip could negate the need for diabetics to prick their fingers multiple times per day: the “Holy Grail” of diabetic treatment
According to the American Diabetes Association, 25.8 million people in the U.S., or 8.3% of the population, have diabetes
Annual cost of treating diabetics in U.S. exceeds $110 billion; expected to triple in 25 years, reaching $336 billion*
* According to University of Chicago research published in Diabetes Care, November 2009
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GlucoChip Design
BIOCOMPATABLE MEMBRANE
BLOODSTREAM GLUCOSE
SIGNAL TRANSDUCTIONAND RFID ELECTRONICS
GLUCOSE BINDING ENVIRONMENT
COMPETITION/SIGNALING COMPONENT
Integrated sensor device design
Application Specific Integrated Circuit(electrical sensor circuitry)
Antenna coil(RFID enabled communication)
Mass Signal Detection
Reference Environment(No receptors)
Competition /Signaling Component
Biocompatible membrane
Bloodstream Glucose
Glucose Binding Environment(Receptors in crystal)
Glucose Sensor Complete Assembly – Mass Detection Type
SENSING SYSTEM
SENSOR ELECTRONICS
Components of the sensing/communication device
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GlucoChip Market Opportunity
Assumptions
• Total market size equals 25 million diabetics in the U.S.
• End user sale price of $90 per device• Estimated one-year life of device• No sales of scanners or other revenue
streams assumed
(Device sales in $ millions on annual basis)
Timeline
• Sensing system completed in Q3 2011
• Membrane diffusion and biocompatibility testing Q4 2011-Q1 2012
• Sensor optimization and development of MEMS through mid-2012
• ASIC development and miniaturization mid-2012 - early 2013
• Animal testing and commercial partner Q1 2013
Total market size for device sales
5% 10% 25% 50%
Market penetration*
*Does not include any assumption of growth in diabetic market.
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$113
$225
$563
$1,125
MicroFluidic Systems
MFS specializes in the development and production of automated systems for a wide range of applications in the detection and processing of biological samples
Founded in 2001, MFS has received over $45 million in government and commercial contracts in the last 10 years
Core technologies include sample prep, nucleic acid (DNA and RNA) and protein detection, automated fluidics and integrated systems
Focused on homeland security and pathogen diagnostic testing (field/clinical/ hospital) opportunities
Strong IP portfolio (29 U.S. Patents and Patents pending) and world-class scientific expertise
Acquired in May 2011; initial consideration of $1.4 million, primarily paid in stock. Additional earn-out of $7.0 million over four years based on revenue and earnings targets
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M-BAND Overview
M-BAND Integrated Pathogen Detection Systems Bio-aerosol monitors with fully integrated systems with sample collection,
processing and detection modules. Each module is fully functional and adaptable. MFS has implemented its own biological assays.
Key technologies: Multiplexed assays Networked, remotely operating Cell lysis, nucleic acid purification Homogeneous, Taqman PCR Monoclonal antibody-based toxin detection
Product differentiators: Rapid confirmation High sensitivity Fully autonomous operation Complete integration of sample collection through toxin and
pathogen detection
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MFS Market Opportunity
BioWatch – M-BAND
Total value of BioWatch opportunity is $3.1 billion over approximately five years
Acquisition of biodetectors and replenishment is expected to be 30-40% of total
We are one of only two potentially qualified biodetector systems suppliers
Net margins of 15-20% expected Updated RFP expected by Q1 2012
Other opportunities
MFS has submitted or in-process bids totaling $40 million, some of which are expected to be awarded in early 2012
Opportunities include HHS, DHS, DTRA (Army) and NASA
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DragonFly Overview
Dragonfly Integrated Diagnostic Systems Microfluidic cartridges for biological sample processing and detection including
differential extraction cartridges, sample processing and amplification for biodefense applications, and clinical sample processing and detection.
Key technologies: Rapid PCR Amplification Fluorescent detection Microfluidic Disposable Cartridges Automated fluidics Rapid cell lysis, nucleic acid purification
Product differentiators: Fast results with high integrity Affordable, disposable, portable Automated and easy to use Small operating footprint
Applications: Environmental bacteria, e.g. E. coli Clinical samples, e.g. HPV Antibiotic-resistant bacteria, e.g. MRSA Biothreat agents Forensic applications
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Investment Highlights
Unique, patent-pending technologies addressing large markets with significant unmet needs for new products
Strong management team and outstanding scientists with proven track records
FDA clearance for iglucose received in November 2011 – product launch expected by early 2012
Easy Check clinical studies commenced in Q4 2011 Significant BioWatch opportunity and strong pipeline of $40
million in potential new government contract opportunities Initial partnerships in place
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Balance Sheet
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(in 000s) 9/ 30/ 2011 12/ 31/ 2010
AssetsCurrent assets:Cash and cash equivalents 472$ 1,764$ Other current assets 186 1,478 Total current assets 658 3,242
Property and equipment, net 54 49 Goodwill 510 --Intangibles 1,487 --Other Assets 258 24 Total assets 2,967$ 3,315$
Liabilities and Stockholders’ Equity (Deficit)Current liabilities:Accounts payable 851$ 490$ Accrued expenses and other current liabilities 1,164 1,219 Total current liabilities 2,015 1,709
Contingent earnout liability 750 --Stock obligation to related party 3,394 --
Total stockholders’ equity (deficit) (3,192) 1,606 Total liabilities and stockholders’ equity (deficit) 2,967$ 3,315$
Cap Structure
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(Amounts in thousands)
Current Basic Full Dil.
Common Shares
Insider & Affiliate 38,068 47.4% 43.0%
Public Float 42,314 52.6% 47.8%
Total Shares 80,382 100.0% 90.8%
Preferred Shares 3,697 4.2%
Stock Options 4,144 4.7%
Warrants 304 0.3%
Total Diluted Shares 8,145 5.0%
Fully Diluted 88,527 100.0%
Ownership %