VTEQ Presentation july 2014

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Vteq presentation july 2014

Vteq presentation july 2014

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  • 1. July 2014
  • 2. Safe Harbor Statement 2 Statements made in this presentation regarding VeriTeQ Corporation (“VeriTeQ” or “Company”) and VeriTeQ that are not historical facts are forward-looking statements based on our current expectations, assumptions, estimates and projections about VeriTeQ and our industry. These forward-looking statements are subject to risks and uncertainties that could cause actual future events or results to differ materially from such statements. These forward-looking statements include, without limitation, statements about our proposed name change and reverse stock split, our commercialization activities, market opportunities, our strategy, our competition, FDA regulation, partnership opportunities, market penetration, and all other forward-looking statements. You should not place undue reliance on any of the forward-looking statements made in this presentation. Our actual results could differ materially from those expressed or implied by these forward-looking statements as a result of various factors, including risks and uncertainties related to the timing or successful completion of our product commercialization activities, VeriTeQ’s ability to raise capital, and other various risks and uncertainties. Additional information about these and other factors that could affect VeriTeQ’s business is set forth in its various filings with the Securities and Exchange Commission, including those set forth in its Form 10-K filed on April 15, 2014, and Forms 10-Q filed on July 16, 2013 and November 14, 2013, and May 14, 2014 under the caption "Risk Factors." The Company undertakes no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future. This presentation does not constitute a prospectus or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, or any offer to underwrite or otherwise acquire any shares in the Company or any other securities, nor shall they or any part of them nor the fact of their distribution or communication form the basis of, or be relied on in connection with, any contract, commitment or investment decision in relation thereto, nor does it constitute a recommendation regarding the securities of the Company.
  • 3. Company Background 3 VeriTeQ originated as a private company founded in 2011 to acquire and develop core implantable RFID intellectual property for healthcare Acquired/licensed/developed 100+ patents (issued or pending) Multiple regulatory clearances: FDA and CE Mark Completed share exchange agreement with DigitalAngel Corporation on July 8, 2013; company changed its name toVeriTeQ VeriTeQ shareholders own ~88% of resulting company Closed $1.5m bridge financing on Nov. 13 Ticker changed to “VTEQ” on Nov. 19
  • 4. Unique Value Proposition 4 In July 2012, the Healthcare Safety and Innovation Act was signed into law and in Sept. 2013, the FDA issued a Final Rule requiring all medical devices in the U.S. that are re- usable and re-processed to carry a unique device identifier, or UDI, with direct part marking VeriTeQ’s FDA cleared UDI, called Q Inside SafetyTechnology, can serve as a direct part marking to help device manufacturers comply with the Final Rule, and can also identify a permanent implantable medical device, in vivo, on demand Q Inside SafetyTechnology goes beyond device identification and provides clinical and healthcare benefits via customizable software and data analytics VeriTeQ also offers FDA cleared radiation dose measurement technologies to protect patients undergoing cancer treatment VeriTeQ’s implantable and wearable dosimetry products provide radiation levels from the patient to help prevent overdose and under-dose
  • 5. Company Overview 5 VeriTeQ provides proprietary, innovative healthcare solutions for Unique Device Identification and Bio-Sensing/Radiation Dosimetry applications CoreTechnology: implantable radio frequency (RF) microchip technology Cleared by the FDA as the Predicate Class II medical device in the industry UDI products enable access to UDI information, in-situ, on demand, at the point of use A leading industry position to enable compliance with FDA Final Rule Q Inside SafetyTechnology also enables data analytics for evidence-based medicine Bio-sensing technologies for radiation dosimetry provide real-time measurements of received radiation dose from the patient, not the machine External and internal product applications Helps prevent radiation overdosing and under-dosing
  • 6. Lead Business Areas 6 Medical Device UDI/Q Inside SafetyTechnology Breast Implants and Breast Implant Sizers Vascular Ports Other Reusable and Implantable Medical Devices Bio- Sensing/Radiation Dosimeter Technologies External Radiation Dosimeter Implantable Radiation Dosimeter
  • 7. TheVeriTeQ UDI System Medical Devices with Inside SafetyTechnology 7
  • 8. FDA Final Rule 8 The Final Rule requires devices intended to be used more than once and intended to undergo any form of reprocessing before each use, i.e. re-useable/reprocessed medical devices to have a direct part marking (vs. basic labeling on device packaging) Requires the direct part marking to be provided through either or both of the following: Easily readable plain text; Automatic Identification and Data Capture (AIDC), or an alternative technology, that will provide the UDI of the device on demand Benefits of a UDI System Allows more accurate reporting and analysis of adverse events to quickly identify problem devices Reduces medical errors by quickly and accurately identifying a device and its characteristics Provides a standardized identifier that allows manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls Provides a consistent way to enter information about devices in electronic health records and clinical information systems Provides a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies
  • 9.  Implantable RFID Microchips  Patented and FDA cleared  Provides the primary key information  Pocket Readers  Patented and FDA Cleared  Pocket Reader  Pocket Reader EX VeriTeQ’s UDI System: Inside  Database  Customization for device manufacturer  Informatics  Integration with FDA database 9
  • 10. UDI Business Model 10 VeriTeQ acts primarily as a supplier of its proprietary microchips and readers to medical device manufacturers Manufacturers incorporateVeriTeQ’s products into their manufacturing processes/distribution strategy (to hospitals, physicians, etc.) Price per chip = $12-15; gross margin per chip = 65 - 75% margins Price per reader = $300-500; gross margin per reader = 40 – 60% margins VeriTeQ also provides development services to medical device manufacturers Primary development areas include design and manufacturing process to include chip in their medical device, i.e. new encasement technologies such as special polymers and heat resistant microchips Avg. price for development per manufacturer = $250,000; gross margin = 50% Data services include database connectivity to manufactured microchips, application software to collect microchip/medical device model implanted, FDA data base registry and informatics analytics. Priced on per project development ranging from $25,000 to several hundred thousand dollars
  • 11. Targeted Customers 11 Breast Implant/Sizers Manufacturers Vascular Port Manufacturers Artificial Joint/Sizers Manufacturers HeartValue Sizers, Endo/ Surgical Equipment
  • 12. Breast Implants 12 VeriTeQ’s Q Inside SafetyTechnology can be embedded within breast implants and sizers to automatically identify the medical device in situ or after re-sterilization. Ex-US:Agreement with Establishment Labs/Motiva Leading global breast, body and facial aesthetic company that manufactures advanced silicone-filled breast implants, marketed under the Motiva Implant Matrix brand name Manufacturing completed and CE Mark certifications achieved Launched Q1-2014 (EU and UK); Over 500 women implanted US: Market leading breast implant manufacturer is testing feasibility to integrate the Q Inside in its silicone implants and sizers Discussions ongoing with the two leading global breast implant manufacturers regarding need to identify their sizers to comply with FDA Final Rule Company estimates sizer market at 600,000 devices annually
  • 13. Vascular Ports 13 Partnership with Medcomp (a leading manufacturer of vascular ports) to utilize Q Inside for Medcomp’s FDA-cleared vascular ports $3 million initial contractual PO commitment from Medcomp Enables accurate device identification and medication dosage Hospital studies expected to begin at: Northwestern Memorial in Chicago NewYork-Presbyterian – University Hospital of Columbia and Cornell in NY Cleveland Clinic in Cleveland, OH or MDAnderson Cancer Center in Houston,TX Medcomp /VeriTeQ targeting to set clinical UDI standard to incentivize other port manufacturers to use Q Inside – e.g. C.R. Bard, Smiths Medical, etc.
  • 14. Artificial Joints and Sizers 14 Identification of implantable and reusable medical devices such as sizers used in joint replacements (subject to Final Rule) Artificial hips in the U.S.: Number of procedures: 230,000 Total annual expenditure: $10.5 billion Average cost per procedure: $45,000 Major manufacturers: Zimmer (24%), Stryker, DePuy/J&J, Biomet,Wright Medical Artificial knees in the U.S. Number of procedures: 543,000 Total annual expenditure: $12 billion Average cost per procedure: $22,000 Major manufacturers: Zimmer (24%), Depuy/J&J, Stryker, Biomet, Smith & Nephew Active initial meetings/dialog with lead target device manufacturers Clinical benefits: Q Inside SafetyTechnology allows for immediate data retrieval; can help quickly resolve adverse event reporting and recalls As published on July 18,2011 in 24/7Wall St.’s Eleven Most Implanted Medical Devices In America
  • 15. VeriTeQ Bio-Sensors In Situ Measurement of Radiation Dosages 15
  • 16. Sensing Technologies 16 VeriTeQ owns Patent 7,125,382 for an “Embedded Bio-Sensor System,” a biological sensor on the end of a radio frequency chip Temperature (current) Radiation levels (current) Blood oxygen (future) Pulse (future) Medication levels (future) i.e. post surgery Glucose (licensed to a third party) Others
  • 17. VeriTeQ Dosimetry OneDose ExternalTechnology Q Inside SmartMarker ImplantableTechnology Radiation DoseVerification 17
  • 18. Maximize Tumor Control (High Dose) Minimize Healthy Tissue Toxicity (Low Dose) The greatest challenge for radiation therapy or any cancer therapy is to attain the highest probability of cure with the least morbidity.1 1) Bucci MK, Bevan A and Roach M. Ca Cancer J Clin 2005;55:117-134 Objective of the Radiation Oncologist 18
  • 19. Patient Safety & Radiation Overdose 19 2013: #3 Unnecessary exposures and radiation burns from diagnostic radiology procedures 2012: #2 Exposure hazards from radiation therapy and CT 2011: #1 Radiation overdose and other errors during radiation therapy 2009-10: #4 CT radiation dose 2008: #8 CT radiation dose 2007: #5 Radiation therapy errors According to the ECRI Institute, radiation or CT overdose make the list of theTop 10Technology Hazards each year going back at least five years
  • 20. VeriTeQ OneDose ® 20 OneDose® is an FDA-cleared single-use, external dosimetry system used in the radiation oncology suite to verify radiation dose quickly and conveniently at the skin level Significant IP protection CE Mark to market products in the E.U. OneDose is the only wireless, pre-calibrated, disposable, surface sensor on the market that provides an instant readout of the dose delivered Reimbursement rate per patient (4-6 dosimeters used during treatment) ranges between $260 and $380 In 2010, 1.1 million patients received radiation therapy in the U.S.* with new indications for use in CT and fluoroscopy markets Researchers at the National Cancer Institute estimate that 29,000 future cancer cases could be attributed to the 72 million CT scans performed in the country in 2007 Over 5 million fluoroscopic procedures performed annually in the U.S.** * According to a study published by IMV Medical Information Division **National Council on Radiation Protection and Measurements, report No. 168 (2010)
  • 21. Q Inside SmartMarker 21*Source = ASTRO,American Society of Radiation Oncology World’s first and only implantable wireless radiation dosimeter; FDA cleared for use in prostate and breast cancer radiotherapy Enables radiation oncologists to immediately measure the dose of radiation penetrating a tumor or tumor area Cleared for use in photon external beam and hypo-fractionated treatment protocols Potential additional new indications for use include lung, colorectal and pancreatic cancer Only device that confirms radiation dose delivered to tumor Can also be used as a fiducial marker for localization of the tumor Device is reimbursable by both Medicare and private insurance FDA cleared & CE mark; significant patent protection Approximately 81,580 patients receive seed implants per year in the U.S. and more than 425,000 patients are diagnosed with prostate and breast cancers total each year in the U.S.*
  • 22. Bio-Sensor Business Model 22 To be sold to radiation oncology centers in the U.S. and E.U. Radiation oncologists, therapists, physicists, dosimetrists Over 4,400 radiation oncologists in the U.S., with 4 states representing 33% of the U.S. market To be sold through direct sales, worldwide distribution partners, product specific website, trade associations Price for One Dose Reader Kit = $499; gross margin = 80% Price for Q Inside SmartMarker Kit = $1,200; gross margin = 80% Potential distribution partners:
  • 23. Intellectual Property 23 VeriTeQ has a robust portfolio of more than 100 patents, patents pending and licenses in the U.S. and abroad. VeriTeQ’s foundation patents are an Embedded Bio-Sensor System on the end of a RF microchip (Patent 7,125,382 issued in 2006), and the use of implantable sensors for monitoring tumors in oncology applications (Patent 6,402,689 issued in 2002). A partial list of the Company’s key patents follows. Patent No. Title 7,125,382 Embedded Bio-Sensor System 6,402,689 Methods, Systems and Associated Implantable Devices for Dynamic Monitoring of Physiological and Biological Properties of Tumors 7,378,056 Methods, Circuits, and Compositions of Matter for In Vivo Detection of Biomolecule Concentrations Using Fluorescent Tags 7,011,814 Systems, Methods And Devices For In Vivo Monitoring Of A Localized Response Via A Radiolabeled Analyte In A Subject 7,479,108 Implantable Sensor Housing, Sensor Unit And Methods For Forming And Using The Same 7,495,224 Disposable Single-Use External Dosimeters For Use In Radiation Therapies 7,966,054 Disposable Single-Use External Dosimeters For Detecting Radiation In Fluoroscopy And Other Medical Procedures/Therapies 7,491,942 Disposable Single-Use Internal Dosimeters For Detecting Radiation In Medical Procedures/Therapies 7,010,340 Methods, Systems, and Computer Program Products for Providing Dynamic Data of Positional Localization of Target Implants 7,510,699 In Vivo Fluorescence Sensors, Systems, And Related Methods Operating In Conjunction with Fluorescently Labeled Materials 7,557,353 Single-Use External Dosimeters for Use in Radiation Therapies and Related Methods, Systems and Computer Program Products
  • 24. Leadership Team 24 Scott R. Silverman Chairman & CEO Mr. Silverman has been Chairman and CEO of VeriTeQ since its inception in Dec. 2011. He served as Chairman and CEO of PositiveID Corp. (OTC:PSID) from 2008 to Aug. 2011, and Chairman and CEO of VeriChip Corp. (NASDAQ:CHIP) from Dec. 2006 to Jul. 2008. He was Chairman of Digital Angel Corp. from 2003 to 2007. From 2003 to 2006, Mr. Silverman served as Chairman and CEO of Applied Digital Solutions (NASDAQ:ADSX). Mr. Silverman is an attorney licensed to practice in NJ and PA, and has more than 15 years of executive experience with technology companies. He is a graduate of the University of Pennsylvania and Villanova School of Law. Randolph K. Geissler President Mr. Geissler has been President of VeriTeQ since July 2012. He developed the implantable microchip, with more than 150 million microchips implanted in animals for identification and tracking. He previously served as CEO of Geissler Technologies (2004 - 2008) when he sold the company's product development pipeline. Prior to that, he served as CEO of Digital Angel Corp. (Amex: DOC) (2000 - 2003) and Destron Fearing (Nasdaq: DFCO) (1993 - 1999), a company he founded. He has taken companies public and has broad experience in product development, electronic miniaturization, application of advanced technologies in new markets, and extensive experience in establishing strategic intellectual property and patent portfolios. Michael Krawitz Chief Legal and Financial Officer Mr. Krawitz was most recently the CEO of Pear Energy, a renewable energy company that finances renewable energy and energy efficiency projects. He previously served as CEO of Florida Sunshine Investments I, Inc., which manages more than $1 billion worth of properties throughout the United States. He is also a member of the Company's Board of Directors. Mr. Krawitz earned a bachelor of arts degree from Cornell University and a Juris doctorate from Harvard Law School. AllisonTomek Sr.VP IR & Corporate Communications Ms. Tomek has served as Sr. VP of VeriTeQ since its inception and has served as Sr. VP, IR and Corp Comm of PositiveID since January 2007. From Jan. 2007 to Jun. 2008 she was also VP of IR at Applied Digital Solutions and Digital Angel. From 2003 to 2006, Ms. Tomek was Director of IR and Corp Comm at Andrx Corp. (NASDAQ:ADRX). Ms. Tomek is the former President of the National Investor Relations Institute, South Florida chapter and a current member of its Board.
  • 25. Capitalization 25 Shares Held Percent Ownership Officers and Directors 6,680,854 61% Float 4,287,988 39% TOTAL 10,968,842 100%
  • 26. Near-Term Goals 26 First product launched; marketing of Motiva breast implants with Q Inside SafetyTechnology in EU/UK Enter into more partnership/supply agreements post Final Rule Enter into partnership for data analytics platform development Continued expansion of patent portfolio surrounding Q Inside SafetyTechnology for medical devices Additional future partnerships
  • 27. Investment Highlights 27 Unique industry technology and market position for its Q Inside Safety Technology unique device identification products FDA cleared device that meets the UDI direct marking mandate for reusable medical devices under the FDA Final Rule provides for “first to market” capability IP provides strong competitive position for long term strategic advantage Launch of Q Inside breast implants in Q1 2014 Commercial partnership with Establishment Labs/Motiva for ex-US markets More than 500 women have received Motiva implants with Q Inside SafetyTechnology Major US manufacturer currently in prototype stage Preparing for immediate expansion into markets forVascular Ports and Orthopedic Implants Commercial partnership with MedComp in place VeriTeQ Radiation Dosimetry products – ready to move into commercialization Radiation dosimeters used in the treatment of cancer Unique patented technologies with multiple regulatory approvals provide competitive advantage in respective markets
  • 28. Q&A Thank you!