Slide 1: Q3 2013 Earnings Review
Cyto Sorbents Corporation OTCBB: CTSO Q3 2013 Earnings Review November 6, 2013
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: Conference Call Participants
3 Conference Call Participants Dr . Phillip Chan, MD, PhD Chief Executive Officer and President Vincent Capponi, MS Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Dr . Christian Steiner, MD Vice President of Sales and Marketing Christopher Cramer, MS, MBA Vice President of
Slide 4: Overview
4 Overview
Slide 5: CytoSorbents is a critical care focused company working to save lives
5 Cyto Sorbents (OTCBB: CTSO) is a critical care focused company working to save lives by targeting uncontrolled inflammation through blood purification
Slide 6: Inflammation Plays a Major Role in Nearly Every Known Disease
6 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 • N
Slide 7: Severe Inflammation Drives Organ Failure
7 Severe Inflammation Drives 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 8: CytoSorb Removes the Fuel to the Fire
8 Cyto Sorb ® Removes the Fuel to the Fire CytoSorb ® is the only specifically approved extracorporeal cytokine filter in the E.U. Cytokines and other inflammatory mediators are the substances that drive inflammation Clinically proven to reduce key cytokines in blood by 30 - 50% in critically ill pa
Slide 9: CytoSorb Is A Powerful New Strategy to Control Severe Inflammation
9 Cyto Sorb Is A Powerful New Strategy 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 trans
Slide 10: The Goal: Actively Prevent or Treat Organ Failure
10 The Goal: Actively Prevent or Treat Organ Failure in Many Life - Threatening Conditions 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 11: The Heart of the Technology
11 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
Slide 12: Bead Technology Enables a Versatile Product Portfolio
12 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 13: $15+ Million in US Government Support
13 • 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 14: Q3 2013 Financial Highlights
14 Q3 2013 Financial Highlights
Slide 15: Third Quarter Key Financial Info
15 Third Quarter Key Financial Info (in thousands of U.S. Dollars) Three months ended September 30, Nine months ended September 30, 2013 2012 2013 2012 Product Sales $ 204 $ 14 $ 508 $ 64 Grant and other income 677 591 1,036 675 Total revenue $ 881 $ 605 $1,544 $ 739 EBITDA $(807 $(552) $(3,433) $(2
Slide 16: Strong Product Growth in Q3 2013
16 Strong Product Growth in Q3 2013 16
Slide 17: Product Sales
Product Sales $700,000 TTM Product Sales $600,000 $500,000 $400,000 $310,779 $300,000 $200,000 $45: $100,000 ] $- Q4 2012 Q4 2013 Q2 2013 Q3 2013 mag CvtOSorbents sing Suv Lins Trough Bisse Petco,
Slide 18: Strong Gross Margins
18 Strong Gross Margins • For the three months ended September 30, 2013 product gross margins were 71% • Overall 2013 product gross margins were approximately 64% • Sales prices have remained constant • Gross margins will vary based on the ratio of direct sales vs. sales to distributors, but are exp
Slide 19: Working Capital: Multiple Sources of Capital to Fund Growth
19 Working Capital Multiple Sources of Capital to Fund Growth • Grant income - continues to provide funding to offset operating costs • Product Sales – high gross margins and increasing sales will drive us closer to cash flow breakeven • Potential strategic partnerships • Raising capital through tra
Slide 20: Q3 2013 Operational Highlights
20 Q3 2013 Operational Highlights
Slide 21: Focus is on Driving Departmental Usage
21 Focus is on Driving Departmental Usage Junior and Senior Physicians Nursing and Technical Staff Key Opinion Leader
Slide 22: Will Have A Number of Reference Sites Soon
22 Will Have A Number of Reference Sites Soon • 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 United Kingdom • Usage of CytoSorb ® at many hospitals is increasing, both in the number of
Slide 23: Actively Expanding our Direct Sales Force
23 Actively Expanding our Direct Sales Force Many Junior and Senior Physicians Many Nursing and Technical Staff ~100 KOLs 2013 Target 7 sales reps & 1 clinical support specialist $ Millions in sales $ Hundreds of thousands in sales
Slide 24: Partnership with Biocon
24 Partnership with Biocon The Largest Biotech in India On World Sepsis Day 2013, BioCon and CytoSorbents announced a strategic partnership with initial distribution in India and select emerging markets Biocon: $467M in 2013 revenue, targeting $1B with $18% CAGR
Slide 25: Biocon Antibiotics + CytoSorb
25 Biocon Antibiotics + CytoSorb ® The Most Comprehensive Treatment for Sepsis Treat the Massive Inflammatory Response Treat the Primary Infection India has 1.2 billion people with one in every 4 patients in the ICU has or develops sepsis in India Biocon expected to contribute to revenue growth for
Slide 26: Investigator Initiated Studies
26 Sepsis ARDS Burns Trauma Surgery Pancreatitis Influenza Life Support Kidney & Liver Failure 26 Investigator Initiated Studies • Up from 18 last quarter • 3 have begun enrollment • Initial data expected in 1H 2014
Slide 27: CytoSorb Case Reports
27 Strictly Confidential - Not for Distribution 27 Cyto Sorbents Case Reports Mortality in patients with septic shock and Candida infection is 64% even with treatment 1 46 year old woman with septic shock and documented Candida albicans infection of an IV port • Critically ill with septic shock mult
Slide 28: CytoSorb Case Reports
28 Strictly Confidential - Not for Distribution 28 Cyto Sorbents Case Reports 80 year old man with end - stage kidney failure on chronic hemodialysis with Type 2 diabetes • Septic shock due to Staphylococcus aureus pneumonia treated with ceftriaxone and clarithromycin • Despite antibiotics, continue
Slide 29: CytoSorb Case Report: alcoholic liver cirrhosis
29 Strictly Confidential - Not for Distribution 37 year old patient with alcoholic liver cirrhosis admitted to ICU because of multi - organ failure due to bilateral pneumonia with Staphylococcus aureus sepsis. Predicted mortality based on CLIF - SOFA score was >90% 27423 Underwent 4 consecutive Cyto
Slide 30: Increased Presence at Major Conferences
Increased Presence at Major Conferences Exhibited • European Society of Intensive Care Medicine - ESICM 2013: Paris, France • 6 th International Congress of the German Sepsis Society 2013: Weimar, Germany • American Association of Blood Banks - AABB 2013: Denver, Colorado • Cytokines 2013: San Franc
Slide 31: Prevention or Treatment of Organ Failure in Cardiac Surgery
31 Prevention or Treatment of Organ Failure in Cardiac Surgery
Slide 32: Cardiac Surgery Stats
32 Cardiac Surgery Stats Approximately 1MM Cardiopulmonary Bypass Surgeries in US and EU annually • Coronary artery bypass graft surgery • Open valve repair • Heart or lung transplantation • Cardiac defect repair Patients often develop inflammation due to cytokine storm and free hemoglobin release d
Slide 33: Simple, Rapid Implementation
33 Simple, Rapid Implementation CytoSorb is installed on cardiopulmonary bypass equipment within minutes and without needing another machine
Slide 34: CytoSorb Is Ideally Suited for CPB
34 Cyto Sorb ® Is Ideally Suited for CPB • Effective removal of excess cytokines and free hemoglobin • Installs into CPB circuit easily and within minutes • Drop - in replacement for leukoreduction filters • Utilizes blood flow generated by the CPB circuit. No need for perfusionist to worry about an
Slide 35: Removal of Free Hemoglobin
35 Removal of Free Hemoglobin Removal of free hemoglobin from partially hemolyzed whole citrated bovine blood following incubation with 1 : 8 v/v CytoSorb beads (L to R : T 0 , 3 , 18 h) at 12 rpm . Plasma fractions are shown following centrifugation . Hours of Incubation
Slide 36: Cardiac Surgery Is a Major Opportunity
36 Cardiac Surgery Is a Major Opportunity • Cardiac surgeons and patients both want zero complications • Although early, the initial experience with many cardiac surgery patients is very promising • Clinical trials can be done rapidly in this space • Represents a total addressable market >$500 milli
Slide 37: $200K NHLBI SBIR Award for HemoDefend
37 $200K NHLBI SBIR Award for Hemo Defend ™ • Collaborating with Dr. Larry Dumont, MD, MBA – Director of the Center for Transfusion Medicine Research and Associate Professor of Pathology at the Geisel School of Medicine at Dartmouth • The goal is to further develop and characterize the HemoDefend te
Slide 38: Progress on Dosing Study
38 Progress on Dosing Study Goal: To determine the safety and preliminary efficacy of extended treatment to help inform the design of a U.S. pivotal sepsis trial • Enrollment has accelerated with a total of 8 clinical sites including: • University of Goettingen • Helios Erfurt • University of Aachen
Slide 39: Proud Sponsor of World Sepsis Day and Sepsis Heroes
39 Proud Sponsor of World Sepsis Day and Sepsis Heroes A lot depends
Slide 40: Comments on Q4 2013
40 Comments on Q4 2013 • Seeing continued strong momentum of CytoSorb® sales into early Q4 2013 • Expecting record fiscal performance for all of 2013, our first full year of commercialization
Slide 41: Why Is CytoSorbents Attractive Now?
41 Why Is CytoSorbents Attractive Now? We are at the “ground floor” of commercialization, poised to create significant value with an approved product , Cyto Sorb ® , that may revolutionize critical care medicine, save lives, and reduce costs Blockbuster potential: Massive market with one of the bigg
Slide 42: Question and Answer Session
42 Question and Answer Session 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 Investor Contact Alliance Advisors, LLC Alan Sheinwald asheinwald@allianceadvisors.net Valter Pinto