Slide 1: An Emerging Leader in Critical Care Immunotherapy
Cyto Sorbents Corporation OTCBB: CTSO An Emerging Leader in Critical Care Immunotherapy Biotech Showcase Presentation January 15, 2014
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiary CytoSorbents, Inc that are not historical facts are forward - looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ
Slide 3: CytoSorbents Overview
3 Cyto Sorbents Overview CytoSorbents is a publicly - traded critical care immunotherapy company specializing in the removal of toxic substances from blood
Slide 4: The Heart of the Technology
4 The Heart of the Technology The underlying blood purification technology is based on biocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood • Protected by 32 issued US patents and multiple applications pending • Manufactured at our ISO 13485 c
Slide 5: Our Bead Technology Enables a Versatile Product Portfolio
5 Critical Care, High Risk Surgery Our Bead Technology Enables a Versatile Product Portfolio Blood Collection & Transfusion CT Imaging, Interventional Radiology Contrast Sorb Drug Overdose, Chemo Removal Drug Sorb Beta Sorb Improving Dialysis Under Development CE Mark Approved
Slide 6: Management Team
6 Management Team Phillip Chan, MD, PhD – Chief Executive Officer and President Board - certified Internist . MD/PhD from Yale School of Medicine . Internal Medicine residency at the Beth Israel Deaconess Medical Center at Harvard . Former Partner at NJTC Venture Fund leading life science investment
Slide 7: Leading Advisors in Critical Care
7 Leading Advisors in Critical Care John Kellum, MD University of Pittsburgh Mitchell Cohen, MD University of San Francisco (UCSF) Raul Coimbra, MD, PhD University of San Diego (UCSD) Ronald Maier, MD University of Washington, Seattle Ernest Moore, MD University of Colorado Emil Paganini, MD Clevela
Slide 8: $15+ Million in US Government Support
8 • US Dept of Health and Human Services awarded $0.5M grant (2010) for therapies that can save lives and reduce costs under the QTDP Program • NIH grant awarded $7M five year (2006 - 2010) to University of Pittsburgh and Dr. John Kellum to research CytoSorb bead for treatment of sepsis • NIH/NHLBI
Slide 9: The Critical Care Opportunity
9 The Critical Care Opportunity
Slide 10: Targeting uncontrolled inflammation through blood purification
10 Cyto Sorbents is working to save lives by targeting uncontrolled inflammation through blood purification
Slide 11: Inflammation Plays a Major Role in Nearly Every Known Disease
11 Inflammation Plays a Major Role in Nearly Every Known Disease • Life threatening conditions like sepsis & trauma • Autoimmune diseases like rheumatoid arthritis, inflammatory bowel, psoriasis, and lupus • Heart disease, peripheral artery disease • Cancer, cancer cachexia, graft vs host disease •
Slide 12: Cytokines Fuel the Fire of Inflammation
12 Cytokines Fuel the Fire of Inflammation • Cytokines are small proteins that normally help stimulate and regulate the immune system and control inflammation • Cytokines are a dual edged sword • They are required for proper immune system function • However, in mild to moderate excess, cytokines can
Slide 13: Massive Inflammation Leads to Organ Failure
13 Massive Inflammation Leads to Organ Failure Organ failure occurs when vital organs stop working, causing nearly half of all deaths in the ICU , but little can be done to treat or prevent it today
Slide 14: CytoSorb Removes the Fuel to the Fire
14 Cyto Sorb ® Removes the Fuel to the Fire • CytoSorb ® is the only specifically approved extracorporeal cytokine filter in the E.U. • Clinically proven to reduce key cytokines in blood by 30 - 50% in critically ill patients • Approved for use in any situation where cytokines are elevated • Safe: M
Slide 15: How Is It Used?
15 How Is It Used? Place a temporary dialysis catheter in a major vein Connect the device to a standard dialysis machines found in hospitals worldwide Pump blood out of the body and through the cartridge The polymer beads directly contact blood and remove unwanted or toxic substances “Purified” bloo
Slide 16: CytoSorb Is A Powerful New Immunotherapy to Control Severe Inflammation
16 Cyto Sorb Is A Powerful New Immunotherapy to Control Severe Inflammation in the ICU NSAIDS Aspirin Anti - cytokine antibodies Anti - integrin antibodies Anti - oxidants Anti - Inflammatory (too weak) Immunosuppressive (too strong) Immunomodulatory (“just right”) Corticosteroids Chemotherapy Organ
Slide 17: The Goal: To Prevent or Treat Organ Failure
17 The Goal: To Prevent or Treat Organ Failure Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical Critical Care: $10 - 15B Opportunity Improve Patient Outcome and Survival Decrease Costs Of ICU and Patient Care
Slide 18: Spectrum of Immunotherapy
18 Spectrum of Immunotherapy LOW Immune Suppression Infection Cancer Poor healing HIGH Allergy Autoimmune Asthma Anaphylaxis Sepsis/SIRS Organ Failure Cancer Immunotherapy Companies Cyto Sorb - $65M • Approved in EU • Generating Revenue • 30+ post market studies • Massive market NORMAL
Slide 19: Competition: No Approved Therapies to Prevent or Treat Organ Failure
19 Competition 19 No Approved Therapies in the EU or US to Prevent or Treat Organ Failure Sepsis ARDS and ALI Burn injury Trauma Severe Acute Pancreatitis Cardiopulmonary bypass Complications of surgery Organ transplant Many others Organ failure remains one of the biggest unmet needs in all of moder
Slide 20: Blood Purification for Sepsis: Competition
20 Blood Purification for Sepsis: Competition 20 Criteria Cyto Sorb Septex Ultraflux CPFA PMMA AN69 ST Toraymyxin CytoPherx Manufacturer Cyto Sorbents Gambro Fresenius Bellco Toray Gambro Toray CytoPherx Used for sepsis treatment in EU? √ √ √ √ √ √ √ î Specific approval as a cytokine filter? √ î î î
Slide 21: Operating and Financial Highlights
21 Operating and Financial Highlights
Slide 22: An Excellent Business
22 Huge market . CytoSorb ® is sold to hospitals and critical care physicians, targeting a “need to have” $ 10 - 15 billion critical care opportunity addressing organ failure Little competition . CytoSorb is the only specifically approved cytokine filter Critical care physicians understand the probl
Slide 23: Direct Sales: Germany, Austria, Switzerland
23 Direct Sales: Germany, Austria, Switzerland We are currently working with KOLs in the largest and most important university and public hospitals in most major cities in Germany and many in Austria and the UK Partial List: • University of Aachen • University of Bonn • Helios Berlin Buch • Charite
Slide 24: 2013: Key Opinion Leader Support
24 2013: Key Opinion Leader Support ~100 KOLs Hospital Administration Product Ordering Clinical Trials Case Reports Papers Conferences Supporting Usage in Department Reimbursement 4 Sales People We launched CytoSorb® in 2H 2012 with a direct sales force of 4 people in Germany, Austria, and Switzerla
Slide 25: 2014: Drive Departmental Usage
25 2014: Drive Departmental Usage Junior and Senior Physicians Nursing and Technical Staff We are starting this phase now Key Opinion Leader
Slide 26: Actively Expanding our Direct Sales Force
26 Actively Expanding our Direct Sales Force Many Junior and Senior Physicians Many Nursing and Technical Staff ~100 KOLs Near - term Target: 7 sales reps & 2 clinical support specialists $ Millions in sales $ Hundreds of thousands in sales Revenue Multiplying Effect
Slide 27: Driving Clinical Data
27 Driving Clinical Data 27 30+ Investigator Initiated Studies European Pivotal Sepsis Trial US Pivotal Trial European Registry US Air Force Funded Trauma Pilot Case Reports Germany Dosing Study 2013 2014 United States Studies European Studies: Dr. Rainer Kosanke – European Director of Scientific Af
Slide 28: 30+ Investigator Initiated Studies
28 Sepsis ARDS Burns Trauma Surgery Pancreatitis Influenza Life Support Kidney & Liver Failure 30+ Investigator Initiated Studies • Initial data from several expected in 1H 2014
Slide 29: Expanding Worldwide Distribution
29 Expanding Worldwide Distribution Signed UK, Ireland, Netherlands, Turkey, Russia and India. Expanding to other parts of Europe and other countries outside the EU that accept the CE Mark Middle East
Slide 30: Strategic Partnership with Biocon
30 Strategic Partnership with Biocon The Most Comprehensive Treatment for Sepsis Treat the Massive Inflammatory Response Treat the Primary Infection Focus is initially on exclusive distribution in India and emerging markets
Slide 31: 2013 Financials
31 2013 Financials • First full year of CytoSorb ® commercialization • Expect to report ~$2.4 million in 2013 revenue • Total CytoSorb® sales for 2013 are expected to be greater than $840,000 • Q4 2013 product sales are projected to be more than $330,000, an increase of more than 60% over the previo
Slide 32: Strong Product Growth Since Introduction
32 Strong Product Growth Since Introduction $13,679 $87,960 $176,098 $127,969 $203,561 $330,000 $0 $50,000 $100,000 $150,000 $200,000 $250,000 $300,000 $350,000 $400,000 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 PROJ CytoSorb ® Product Sales $360,000 High and low estimates 32
Slide 33: Product Sales (TTM)
33 Product Sales (TTM) $151,574 $310,779 $405,706 $595,588 $850,000 $- $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 $700,000 $800,000 $900,000 $1,000,000 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 PROJ Trailing Twelve Month Product Sales Trend Line
Slide 34: Strong Gross Margins
34 Strong Gross Margins • For the three months ended December 31, 2013 product gross margins are expected to exceed 60% • Sales prices have remained constant through Q4 2013 • Gross margins will vary based on the ratio of direct sales vs. sales to distributors, but are expected to remain very health
Slide 35: Major Catalyst Is Expected To Be Sales
35 Major Catalyst Is Expected To Be Sales Product revenues have been growing rapidly. Based on the foundation we laid in 2013, we believe we now have the formula in place for growth. • Strong key opinion leader support • Positive clinical experiences • Increasing orders and reorders • A growing sale
Slide 36: CytoSorbents Poised for Growth
36 Cyto Sorbents Poised for Growth Cyto Sorb ® is a unique immunotherapy product that may revolutionize critical care medicine, save lives, and reduce costs Blockbuster potential: Massive market, major unmet need, could save lives, reduce costs Approved and generating revenue Validation of our compa
Slide 37: Working to Save Lives Through Blood Purification
37 Phillip P. Chan, MD, PhD - CEO 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 pchan@cytosorbents.com Working to Save Lives Through Blood Purification OTCBB: CTSO