Transcript Slide 1
(AMEX Symbol: XCR) Presentation January 14, 2008
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Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this presentation are forward looking and pursuant to the safe harbor provisions of the private Securities Litigation Reform Act of 1995.
These forward-looking statements reflect numerous assumptions and involve a variety of risk and uncertainties, many of which are beyond the company’s control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting, and protecting proprietary technologies, the risk that our technology may not be effective, uncertainty as to the outcome of legal proceedings, intense competition, and substantial regulation in the medical device and healthcare industries, as discussed in the on its website at http:/www.sec.gov.
Company’s periodic reports filed with the Securities and Exchange Commission, available
Management Team
• Terren Peizer Executive Chairman • Winson Tang, • Victor Gura, MD, FACP Chief Operating Officer MD Chief Medical Officer • CEO, Chairman & Founder Hythiam • Amgen, Vertex, Tularik, Isis, Pacific Capital Grp • Cedars-Sinai Med. Cntr, Assoc. Clin. Prof., UCLA • Robert Weinstein, CPA, MBA Chief Financial Officer • Citi Private Equity, Able Labs, GE Capital 3
Selected Board Members
• Hans Polaschegg, PhD • Dan Goldberger, MSME • Kelly McCrann, MBA Fresenius, Chairman Extracorp Circ & Infusion Tech Committee Sound Surgical, Glucon, OSI Systems, Optiscan, Nellcor DaVita, PacificCare, KPMG, McKinsey 4
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Xcorporeal Highlights
•
Extra-corporeal
medical devices that could replace the function of failing or failed organs • Multiple initial products – Portable Hospital Hemodialysis device – Portable Home Hemodialysis device – Wearable Artificial Kidney • First U.S. 510(k) filing Q4, 2008 - FDA clearance expected Q1, 2009 • Minimal to low risk strategy – Prototype device tested successfully in humans – Well defined and straightforward regulatory strategy – Well delineated reimbursement codes • Multi-billion dollar and clearly defined markets
Xcorporeal Renal Replacement Therapy Devices
• Portable Hemodialysis Device - Hospital CRRT/Acute Hemodialysis • Portable Hemodialysis Device - Home Hemodialysis – ESRD • Wearable Artificial Kidney - Home Hemodialysis – ESRD 6
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Xcorporeal Hospital Portable Renal Replacement Device
• Truly portable device – Smaller (< two cubic feet) and lighter than competitor devices (30-40 lbs) – Reduced fluid (dialysate) requirement – Easier to operate, reduced training requirement • Fully functional – Continuous Renal Replacement Therapy (CRRT) – Intermittent Hemodialysis • Product status – Functional prototype undergoing bench testing – FDA 510(k) filing in Q4, 2008
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Xcorporeal Proprietary Disposable Manifold
• The complexity of setting up a dialysis machine has been reduced to a single step of inserting a proprietary manifold into the machine.
• This reduces machine size, disposable cost, and simplifies operation.
Benefits of Xcorporeal Hospital
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Portable Renal Replacement Device
• Decrease workload for hospital ICU staff – No plumbing requirements • Use simple tap water versus bagged dialysate – Simple to use operator interface – Snap-in disposable unit – Simple set-up, tear down and clean-up • Cost effective – Decrease in medical staff time (nurse, pharmacist) – Decrease in staff training downtime – No need for bagged dialysate ($180/treatment) • Flexibility – Truly portable, no utility hookup limitations
Portable Device Development Timeline
10 Q1 Q2 Q3 Q4 Q1 Q2 2008 2009
Hospital Hemodialysis Device Market
• US Market Opportunity = $1.4 billion – Growing at 10% per year • Aging Population • Increasing severity of hospitalized patients • Disposable Market – 242,000 patient hospitalizations per year estimated 2008 – Average 8 days per hospitalization – $500 revenue per day for fluids and disposables – Disposable Market = 242,000 x 8 x $500 = $968 million • Device Market – Market = 62,000 beds x .25/bed x $30k/machine = $465 million 11
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Xcorporeal Home Portable Renal Replacement Device
• Truly portable device – Smaller (< two cubic feet) and lighter than competitor devices (30-40 lbs) – Reduced fluid requirement – Easier to operate, reduced training requirement – No special plumbing nor electrical requirements • Fully functional – Wide range of flow rates – treat larger patients • Product status – Working prototype – FDA 510(k) filing in Q2 2009
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Benefits of Xcorporeal Home Portable Renal Replacement Device
• Truly portable – Substantially smaller and lighter than any existing device – No utility requirements, tap water and 110VAC only • Ease of Use – No fluid handling device – Fully disposable fluid circuit, no cleaning or sterilization – 50 – 600 ml / minute range of flow rates • Ease of Treatment – One step, one-handed set up – Graphical user interface
Home Use Development Timeline
14 Q1 Q2 Q3 Q4 Q1 Q2 2008 2009
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Chronic Hemodialysis Market
• U.S. Market Opportunity = $6.7 billion – 357,000 chronic dialysis patients – 3 treatments per week – $120 Medicare reimbursement / treatment – Market = 357,000 x 3 x $120 x 52 weeks = $6.7 billion • Home hemodialysis penetration is less than 1% today but will grow because – Appropriate equipment becomes available (Xcorporeal, NxStage, Fresenius off label) – Longer, more frequent therapy is better medicine (4+ treatments per week versus 3) – Home hemodialysis reduces capital and skilled labor requirements
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Home Hemodialysis is a significant Growth Opportunity in ESRD
• Patient Benefits – Increased time on hemodialysis with improved outcomes – Potential for daily dialysis – Improved quality of life: diet, sleep, time • Provider Benefits – Decreased need for nurses/techs – Increase in revenues without need for additional infrastructure – More frequent treatments decreases need for expensive medications
Home Hemodialysis Device Comparison
Blood Flow Rates Dialysate Flow Rates Dialysate/4-hr (liters) Dialysate Regeneration Dry Weight (pounds) Size (cubic feet) Portable Drainage Required Installation Cost
* Not marketed.
Xcorporeal 50 – 600 50 – 500 6 Yes < 40 < 2.0
Yes No Low
Renal Solutions (*) 150 - 400 200 - 400 6 Yes 195 16 No No Medium NxStage 50 - 600 50 - 200 20 - 30 No 80 5 Partial Yes Medium Fresenius 2008K 20 - 600 100 - 800 120 No 160 16 No Yes High 17
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Xcorporeal Wearable Artificial Kidney
• “Disruptive” technology • Wearable, battery operated light-weight device • Fully automated, simple to use • Prototype tested successfully • Successful human trials published in The Lancet & Kidney International December 2007 • 24 hrs/7 days therapy with potential to revolutionize care of ESRD patients
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Wearable Artificial Kidney Feasibility Prototype
Patient
Wearable Artificial Kidney
Metering Pump Bi Phase Pump Bubble Sensor Heparin Metering Pump Infusate Metering Pump Blood Sensor Bi Carbonate Sorbent 3 Sorbent 2 Sorbent 1
Blood Loop
Sterile Change weekly in clinic
Metering Pump Waste Drain Valve
Dialysate Loop
Change daily at home
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Clinical Trial Results
• Initial clinical study conducted with a prototype device at The Royal Free Hospital, London – 8 ESRD subjects dialyzed for mean of 6.4 hrs – Clearances of creatinine, urea, and beta-2 microglobulin achieved (chart follows) – No adverse events reported – Subjects were able to walk unhindered during dialysis treatment – Presented at ASN November 5, 2007
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Clinical Trial Results
0% -5% 0:00 -10% -15% -20% -25% -30% -35% -40% -45% -50% 2:00
Time (hrs)
4:00 Urea Creatinine Beta2 Microglobulin 6:00 8:00 • Sustained reductions in key blood chemistries • Clearance of both small and middle molecules • Clearance meets or exceeds daily toxin production
WAK Development Timeline
23 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2008 2009 2010
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Intellectual Property
• Portable Artificial Kidney – 18 patents pending or in process • Wearable Artificial Kidney – Exclusive in-licensed patents • Wearable ultra-filtration device – Wearable, self-contained, device for continuous excess fluid management • Wearable continuous renal replacement therapy device – Expands on patent above to include renal replacement patients and battery-operated power source
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Selected Financial Information
September 30, 2007 • Cash and Marketable Securities - $20.3 million • Shares Outstanding - 14.4 million • Market Capitalization - $72 million at 12/31/07 • $1.2 million monthly cash burn rate
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Company Near-Term Milestones
• Hospital Portable Hemodialysis Device – Functional Prototype (completed) – Pre-Production Prototype – FDA 510(k) submission – Commercialization target Q4, 2007 Q3, 2008 Q4, 2008 Q2, 2009 • Home Portable Hemodialysis Device – Functional Prototype (completed) – Pre-Production Prototype – Clinical trial – FDA 510(k) submission – Commercialization target Q4, 2007 Q3, 2008 Q2, 2009 Q3, 2009 Q4, 2009
Comparable – NxStage Medical (NXTM)
• Emerging growth hemodialysis company • “System One” device – Home hemodialysis: > 2,000 patients; <0.5% market – Hospital CRRT for acute renal failure • Financial Metrics – $560M market capitalization – 12/31/07 • 14x trailing twelve months revenues • 9x annualized Q3, 2007 revenues – Quarter ended September 30, 2007 financial highlights • $33M in cash • $13M operating expenses • $16.1M operating loss 27
Comparable Acquisition Fresenius purchase of Renal Solutions
• $190 million purchase price – $100 million at closing – $60 million in one year, $30 million contingency • Sorbent technology • Allient device – Cleared by FDA over two years ago – Not brought to market • Why significant for Xcorporeal – Suggests sorbent technology valuable – High acquisition price for “scarce” assets 28
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Xcorporeal Highlights
•
Extra-corporeal
medical devices that could replace the function of failing or failed organs • Multiple initial products – Portable Hospital Hemodialysis device – Portable Home Hemodialysis device – Wearable Artificial Kidney • First U.S. 510(k) filing Q4, 2008 - FDA clearance expected Q1, 2009 • Minimal to low risk strategy – Prototype device tested successfully in humans – Well defined and straightforward regulatory strategy – Well delineated reimbursement codes • Multi-billion dollar and clearly defined markets
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APPENDIX
Management Team
• Nina Peled, PhD, MBA SVP - Quality & Regulatory • James Braig, MSME SVP - Product Dev.
• Barry Fulkerson VP - Hardware Systems • Russ Joseph, MS VP - Disposable Engineer Hansen, Cygnus, Amira, Lumenis, i-STAT, BM Optiscan, Square One Tech, Ohio Medical NxStage, COBE (Prisma, CS3), Gambro Gish Biomedical, Sorin, Baxter Healthcare 31
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Product Development Team
• Internal team of engineers with expertise in dialysis equipment and disposables who previously worked at Cobe, Gambro, Aksys, NxStage and Baxter • Contract Product Development Group in Southern California to leverage the expertise of an additional 10-15 engineers • Manufacturing to be outsourced
Renal Disease Overview
33 • Acute Renal Failure – Hospital-based, majority in Intensive Care Unit – 200,000 acute renal failure patients – 50% mortality rate • End Stage Renal Failure – Approximately 2 million “known” ESRD patients worldwide – 65% of patients expire within 5 years – Patient’s poor quality of life • Care provided primarily outside the home • Non-ambulatory • Intermittent care – Significant peaks and valleys – Constantly ill – Majority disabled
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Reimbursement Codes (CMS/Medicare) are Established
Procedure Ultrafiltration Aquapheresis Acute / CRRT HD Home HD Outpatient HD Code 36514 90935 90925 90921 90925 90921 Amount $720/tx Comments Code for plasmapheresis $406/tx $1800/mo Includes all HD supplies $96-123/tx Varies depending on region
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Regulatory Strategy
Device U.S.
E.U.
Clinical Trials Hospital Hemodialysis 510(k) Home Hemodialysis 510(k) Wearable Artificial Kidney PMA CE None CE CE 30-40 patients Estimate 100 200 patients
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Renal Replacement Therapy Market Opportunity -
Company estimates
$ in millions
US Europe Asia Total Hospital Renal Replacement Device:
Disposables Device Total Hospital RR Device $968 $465 $1,433
ESRD-Home Renal Replacement Device and Wearable Artificial Kidney:
Total Home RRD and WAK
Total All Devices
$6,704
$8,137
$660 $465 $1,125 $484 $232 $716 $2,112 $1,162 $3,274 $7,146 $3,537 $17,387
$8,271 $4,253 $20,661