Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — BIO Investor Presentation 2016
50 slides from Cytosorbents's conference presentation, Oct 18, 2016
Slide 1: BIO Investor Presentation
HELPING PATIENTS SURVIVE THE RAVAGES OF DEADLY INFLAMMATION WORLDWIDE NASDAQ: CTSO BIO Investor Presentation October 18, 2016
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiaries CytoSorbents Medical Inc. and CytoSorbents Europe GmbH that are not historical facts are forward-looking statements and are subject to risks and uncertainties that could cause actu
Slide 3: CytoSorbents is a Leader in Critical Care Immunotherapy
CytoSorbents is A Leader in Critical Care Immunotherapy Leading the Prevention or Treatment of Life-Threatening Inflammation in the ICU and Cardiac Surgery using CytoSorb® Blood Purification 3
Slide 4: CytoSorbents At a Glance
CytoSorbents At a Glance • NASDAQ-traded (CTSO: $5.50) • International footprint across two wholly-owned operating subsidiaries • CytoSorbents Medical, Inc - Monmouth Junction, NJ • Headquarters, ISO 13485 manufacturing, QA/QC, R&D • CytoSorbents Europe GmbH: International sales office - Berlin, Ger
Slide 5: Severe Inflammation: Deadly in the ICU
Severe Inflammation: Deadly in the ICU Millions worldwide admitted to the intensive care unit annually with deadly inflammatory conditions Cancer Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Immunotherapy ~30M cases ~5M cases ~1.5M cases ~40M cases ~0.5M severe cases ~4M severe cases <1M an
Slide 6: Cardiac Surgery Drives Dangerous Inflammation
Cardiac Surgery Drives Dangerous Inflammation • ~1.5M Open Heart Surgeries performed globally • Coronary artery bypass graft surgery • Valve repair or replacement • Heart or lung transplantation • Congenital defect repair • Aortic reconstruction • Complex cardiac surgeries require long heart-lung ma
Slide 7: Cytokines Fuel the Fire of Inflammation
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 ca
Slide 8: Massive Inflammation Causes Organ Failure
Massive Inflammation Causes Organ Failure Organ failure occurs when vital organs stop working, causing nearly half of all deaths in the ICU. Little can be done to prevent or treat it today 8
Slide 9: CytoSorb Removes the Fuel to the Fire
CytoSorb® Removes the Fuel to the Fire • Targets $20+ billion opportunity in critical care and cardiac surgery • European Union approved as the only specific cytokine filter for elevated cytokines • Clinically proven to remove key cytokines in blood of critically-ill patients • Removes many other in
Slide 10: Powerful Blood Purification Technology
Powerful Blood Purification 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 Each bead is about the size of a grain of salt . • Protected by 32 issued US patents and multi
Slide 11: CytoSorb is Plug and Play with Existing Machines
® CytoSorb is Plug and Play with Existing Machines Easy to Use, No Special Equipment or Training Required 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 T
Slide 12: Goal: To Prevent or Treat Organ Failure
Goal: To Prevent or Treat Organ Failure Improve Decrease Patient Costs Of Outcome ICU and and Patient Survival Care Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical The Potential to Revolutionize Critical Care Medicine 12
Slide 13: $18 Million in U.S. Government Support
$18 Million in U.S. Government Support • DARPA awarded $3.8M five year (2012-present) contract as part of “Dialysis-Like Therapeutics” program to treat sepsis by removing cytokines and pathogen-derived toxins • U.S. Army awarded ~$1.7M SBIR contract for trauma and burn injury research and hyperkalem
Slide 14: The World Needs CytoSorb
Suspect The World Needs CytoSorh® | | | Save Lives — x sim CvtOSoritents Working to Save Lives Through Blood Purification
Slide 15: Key Catalyst #1: Drive CytoSorb Revenues
Key Catalyst #1: Drive CytoSorb Revenues 15
Slide 16: CytoSorb Is a High Margin Razorblade
CytoSorb® Is a High Margin Razorblade • CytoSorb is a high margin razorblade that is fully compatible with the existing installed base of dialysis and ECMO machines in the ICU, and heart-lung machines in the operating room • Average Selling Price is approximately $1,000 per cartridge • Approximately
Slide 17: Direct Sales: Germany, Austria, Switzerland
Direct Sales: Germany, Austria, Switzerland CytoSorbents’ direct sales force focused on most major university and public hospitals in Germany, Austria and Switzerland. German market alone is Dr. Christian Steiner, MD Vice President – Sales and Marketing and General Manager CytoSorbents Europe GmbH $
Slide 18: CytoSorb Distributed in 40 Countries
CytoSorb® Distributed in 40 Countries IntensivMed WMC 18
Slide 19: Quarterly Product Sales
Quarterly Product Sales Fifth consecutive quarter of product sales growth Fourth consecutive quarter of record sales $2,000,000 CytoSorb® Product Sales $1,852,670 $1,800,000 $1,597,449 $1,600,000 $1,495,590 $1,400,000 $1,200,000 $1,071,459 $1,031,761 $1,000,000 $871,150 $800,000 $773,112 $703,658 $6
Slide 20: Trailing Twelve Months Product Sales
Trailing Twelve Months Product Sales Over the past three years, the compound growth rate of return (“CAGR”) on product sales was 145% $8,000,000 Trailing Twelve Month Product Sales $7,000,000 $6,017,168 $6,000,000 $5,000,000 Trend Line $4,000,000 $3,379,681 $3,000,000 $2,000,000 $1,750,196 $1,000,00
Slide 21: Growth Driven by Direct, Distributor, Partner Sales
Growth Driven by Direct, Distributor, Partner Sales * This graph is provided only to demonstrate the concept of revenue layering. It does NOT represent revenue forecasts or guidance 21
Slide 22: Key Catalyst #2: Drive Clinical Data
Key Catalyst #2: Drive Clinical Data to Support CytoSorb As Standard of Care 22
Slide 23: Robust Clinical Program and Team
Robust Clinical Program and Team Chief Medical Officer Cardiac Sepsis Trauma Surgery Advisory Advisory Advisory Board Board Board U.S. Rest of World Sr.Manager Director Director of Clinical Medical Statistician Clinical Scientific Operations Director Affairs Affairs 55+ Investigator Publications Ini
Slide 24: U.S. REFRESH I Trial – Safety Confirmed
U.S. REFRESH I Trial – Safety Confirmed REduction in FREe Hemoglobin • 40-patient, eight-center study evaluating the safety and efficacy of intra- operative use of CytoSorb® in a heart-lung machine during complex cardiac surgery in elective, non-emergent cardiac surgery > 3 hours • Aortic reconstruc
Slide 25: REFRESH I Trial – Safety
REFRESH I Trial – Safety REduction in FREe Hemoglobin Trial • A total of 46 patients were enrolled with ~40 patients with evaluable biomarker data • The Data Safety Monitoring Board (DSMB) evaluated all adverse and serious adverse events in the control and treatment arms, and concluded there was no
Slide 26: New Trials for Severe Sepsis & Septic Shock
New Trials for Severe Sepsis & Septic Shock • Sepsis, the overzealous immune response to a serious infection, is a Top Ten cause of death by causing organ injury, organ failure, and death • Largest, most complex, critical care market; ~30 million people afflicted worldwide each year, estimated 10 mi
Slide 27: CytoSorb Attacks Sepsis Broadly
CytoSorb Attacks Sepsis Broadly Inflammatory cytokines (organ failure) & other factors Immunosuppressive cytokines & re-establish immune responsiveness Many bacterial toxins (organ failure) Re-establish proper leukocyte trafficking to prevent cell-mediated organ injury MAP Improvement in hemodynamic
Slide 28: Many Published Peer-Reviewed Articles
Many Published Peer-Reviewed Articles 28
Slide 29: CytoSorb Website – A Wealth of Info
CytoSorb Website – A Wealth of Info Visit us at www.cytosorb.com 29
Slide 30: Key Catalyst #3: Leverage Pipeline to Establish Strategic Partnerships
Key Catalyst #3: Leverage Pipeline to Establish Strategic Partnerships 30
Slide 31: Beads Enable a Broad and Valuable Pipeline
Beads Enable a HemoDefend CytoSorb-XL Potassium Sorbent Broad and K+ Valuable Pipeline Blood Sepsis, Severe Collection & Critical Care, Hyperkalemia Transfusion High Risk Surgery ContrastSorb DrugSorb BetaSorb Critical Care, CT Imaging, Drug Improving High Risk Interventional Overdose, Dialysis Surg
Slide 32: Three Major Partnerships, Potential for More
Three Major Partnerships, Potential for More Critical Care or Cardiac Catheters Renal Surgery Dialysis Biotech and Blood Transfusion Immunotherapy *Companies listed here are used simply as examples of companies in these respective 32 verticals. We make no other representations to our relationship wi
Slide 33: Terumo Partnership
Partnership • Entered into a multi-year partnership with Terumo Cardiovascular Group, a global leader in medical devices for cardiac and vascular surgery with $5 billion in annual sales across more than 160 countries, for cardiac surgery applications • Initial exclusive distribution of CytoSorb® in
Slide 34: Fresenius Medical Care Partnership
Fresenius Medical Care Partnership • Currently in a multi-year partnership with Fresenius, the world’s largest dialysis company, for exclusive distribution of CytoSorb® in critical care in France, Poland, Denmark, Norway, Sweden, and Finland • CytoSorb® is a key part of Fresenius’ growth strategy in
Slide 35: Biocon Partnership
Partnership Treat Primary Infection with Treat Massive Inflammatory Antibiotics Response with CytoSorb • Biocon is the largest biopharmaceutical company in India • Significant growth in India with expansion into Sri Lanka • Currently funding and conducting the first investigator initiated study in I
Slide 36: Key Catalyst #4: Increase Investor Awareness
Key Catalyst #4: Increase Investor Awareness 36
Slide 37: NASDAQ Capital Market Listed
NASDAQ Capital Market Listed • Clean capital structure with good liquidity for investors 37
Slide 38: Included in Russell Microcap Index
Included in Russell Microcap Index June 2015 38
Slide 39: Newly Launched Corporate Website
Newly Launched Corporate Website 39
Slide 40: Increasing Institutional Ownership
Increasing Institutional Ownership 7.0% Institutional Ownership (6/30/16) 42 Institutional holders 1.8M shares Source: NASDAQ 40
Slide 41: Increasing Media Coverage
Increasing Media Coverage 41
Slide 42: Increasing Analyst Coverage
Increasing Analyst Coverage 42
Slide 43: CytoSorbents Has Tremendous Potential
CytoSorbents Has Tremendous Potential CytoSorbents is a hybrid: Combines the greater visibility and lower risk of a medical device company with product sales with the upside potential of biotech • Massive untapped $20 billion unmet, medical need in critical care • Generating significant internationa
Slide 44: Contact: Dr. Phillip Chan, CEO
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com
Slide 45: CytoSorb Active in Cytokine Sweet Spot
® CytoSorb Active in Cytokine Sweet Spot IL-1a TNF-α monomer Pancreatic Trypsin IFN-γ monomer Toxic Shock Syndrome Toxin IL-1Ra IL-18, Pancreatic Chymotrypsin Myoglobin HMGB1 Procalcitonin TGF-β TNF-α trimer MCP-1 IL-6 Pneumolysin toxin IL-13 sFas ligand Pancreatic Lipase, Amylase Complement C5a SPE
Slide 46: CytoSorb Broadly Reduces Cytokines
® CytoSorb Broadly Reduces Cytokines Cytokine reduction over time during in vitro perfusion with serum (or buffer) IL-6 TNF-a IL-10 IL-1a IL-1ra IL-8 The two lines on each graph represent CytoSorb cytokine removal from serum (triangle) or buffer (square) Valenti, I “Characterization of a Novel Sorbe
Slide 47: CytoSorb Is A New Immunomodulation Strategy
CytoSorb Is A New Immunomodulation Strategy to Control Severe Inflammation in the ICU Anti-Inflammatory Immunosuppressive (too weak) (too strong) NSAIDS Corticosteroids Aspirin Chemotherapy Organ transplant Anti-cytokine Anti-rejection drugs antibodies Radiation Anti-integrin antibodies Immune syste
Slide 48: Blood Purification Competition
Blood Purification Competition Coupled Plasma Sorbents HMCO Filters Filtration Adsorption EMiC2 - Fresenius CytoSorb – CPFA - Bellco CytoSorbents I.M.P.A.C.T - Hemolife SepteX – Gambro CytoSorb is the leader in cytokine and mid-molecular weight toxin removal. It has significant advantages of hemocom
Slide 49: Advanced Development of CytoSorb-XL
Advanced Development of CytoSorb-XL • CytoSorb-XL is a next generation porous polymer bead technology combining lipopolysaccharide (LPS) endotoxin removal with the robust cytokine, toxin, and inflammatory mediator reduction achieved by CytoSorb® • Endotoxin is a very potent stimulator of cytokine st
Slide 50: Refractory Septic Shock
Refractory Septic Shock At the 26th Symposium for Intensive Medicine + Critical Care in Bremen, Germany, Dr. Sigrun Friesecke, Senior Intensivist in the Greifswald University Hospital MICU reported on a prospective, single arm study in 22 patients with refractory late-stage septic shock • Patients h