Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (December 2016)
70 slides from Cytosorbents's investor presentation, December 2016
Slide 1: CytoSorbents Corporation Investor Presentation
CytoSorbents Corporation NASDAQ: CTSO Working to Save Lives Through Blood Purification Investor Presentation December 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): Market cap ~$125M • 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 -
Slide 5: Leadership Background
Leadership Background Phillip Chan, MD, PhD – Chief Executive Officer and President Former Partner at the $80M NJTC Venture Fund, leading life science investments for 5 years. Co-founder of Andrew Technologies, commercializing its HydraSolve™ lipoplasty device in the U.S. MD/PhD from Yale School of
Slide 6: Board of Directors
Board of Directors Al Kraus – Chairman (Audit, Governance, Compensation Committees)* 25+ years leadership experience in the dialysis and medical device industries. Former CEO and Board director of CytoSorbents, NOvoVascular, Althin Medical, and former COO and U.S. manager of Gambro, Inc., one of the
Slide 7: Controlling Deadly Systemic Inflammation
Controlling Deadly Systemic Inflammation 7
Slide 8: 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 9: Cardiac Surgery Drives Dangerous Inflammation
Cardiac Surgery Drives Dangerous Inflammation • Heart disease is the leading cause of death worldwide driven by smoking, unhealthy lifestyles, and an aging population • ~1.5M Open Heart Surgeries performed globally • Coronary artery bypass graft surgery • Valve repair or replacement • Heart or lung
Slide 10: 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 11: 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 11
Slide 12: CytoSorb Removes the Fuel to the Fire
CytoSorb® Removes the Fuel to the Fire • CytoSorb® targets the $20+ billion opportunity in critical care and cardiac surgery • Approved in the European Union as the only specifically approved extracorporeal cytokine filter • Approved for use in any situation where cytokines are elevated • Removes cy
Slide 13: 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 14: 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 15: 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 16: 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 17: 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 17
Slide 18: 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 19: 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 20: $20 Million in U.S. Government Support
$20 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 contracts for trauma and burn injury research and hyperkale
Slide 21: The World Needs CytoSorb
Suspect | | | Save Lives sim CvtOSoritents Working to Save Lives Through Blood Purification
Slide 22: Key Catalyst #1: Drive CytoSorb Growth and Profitability
Key Catalyst #1: Drive CytoSorb Growth and Profitability 22
Slide 23: 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 24: Direct Sales: Expanded to 5 Countries
Direct Sales: Expanded to 5 Countries CytoSorbents’ direct sales force focused on most major university and public hospitals in Germany, Dr. Christian Steiner, MD Vice President – Sales and Marketing and General Manager Austria, Switzerland, Belgium and Luxembourg. German market alone is $1.0-1.5 bi
Slide 25: Dedicated Reimbursement In Germany
Dedicated Reimbursement In Germany • There are various mechanisms by which CytoSorb is being paid for or reimbursed in other countries (e.g. DRG reimbursement, tender orders, etc) • CytoSorb has recently achieved a permanent, dedicated reimbursement code in Germany – our most important market and th
Slide 26: CytoSorb Distributed in 42 Countries
CytoSorb® Distributed in 42 Countries IntensivMed WMC 26
Slide 27: Geographic Expansion – A Growth Engine
Geographic Expansion – A Growth Engine January 2016 November 2016 We continue to add new and existing distributors into the “contributing to revenue” category and many other countries 27
Slide 28: Quarterly Product Sales
Quarterly Product Sales Sixth consecutive quarter of product sales growth Fifth consecutive quarter of record sales $2,143,116 CytoSorb® Product Sales $2,000,000 $1,852,670 $1,597,449 $1,495,590 $1,500,000 $1,071,459 $1,031,761 $1,000,000 $871,150 $773,112 $703,658 $663,233 $569,243 $500,000 $314,15
Slide 29: 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 128% $8,000,000 Trailing Twelve Month Product Sales $7,088,825 $7,000,000 $6,000,000 $5,000,000 Trend Line $4,000,000 $3,419,379 $3,000,000 $2,578,396 $2,000,000 $1,000,00
Slide 30: Outlook for 2H 2016
Outlook for 2H 2016 • CytoSorbents has not historically given financial guidance on quarterly results until the quarter has been completed. • However, we currently expect a strong Q4 2016, with the achievement of numerous operating milestones • In addition, we reiterate our guidance that we expect s
Slide 31: 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 31
Slide 32: Operating Profitability Expected in 2 Years
Operating Profitability Expected in 2 Years Operating profitability is expected within 2 years at ~$20M in sales, at which point an estimated 40-50 cents on every dollar drops to the bottom line Product Revenue vs. Fixed Operating Expense Trends 10,000,000 9,000,000 8,000,000 7,000,000 6,000,000 5,0
Slide 33: Key Catalyst #2: Drive Clinical Data to Support CytoSorb As Standard of Care
Key Catalyst #2: Drive Clinical Data to Support CytoSorb As Standard of Care 33
Slide 34: 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 58 Investigator Publications Init
Slide 35: 3rd International CytoSorb Users Meeting
3rd International CytoSorb Users Meeting For more information, visit: 35 https://www.b2match.eu/cytosorbusersmeeting2016
Slide 36: ISICEM 2016
ISICEM News TEEN Tuma 18 March 2016” Day + Welcome to Brussels... _EitsSorbents. —«.cetlite Symposium NEW CLINICAL, DATA, igh Blood Purification
Slide 37: CytoSorbents ISICEM Research Symposium
CytoSorbents ISICEM Research Symposium 37
Slide 38: Leading US Advisors in Cardiac Surgery
Leading US Advisors in Cardiac Surgery Dr. Joe Zwischenberger, M.D. Dr. Paul Checchia, M.D. - SAB Chair Dr. Robert Bartlett, M.D. Texas Children’s Dr. Jonathan William Haft, M.D. University of Kentucky University of Michigan Hospital in Houston University of Michigan Dr. Nicholas Smedira, M.D. Dr. C
Slide 39: 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 40: 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 reported adverse and serious adverse events in the control and treatment arms, and concluded ther
Slide 41: Recent Clinical Data in Cardiac Surgery
Recent Clinical Data in Cardiac Surgery • Interim analysis of 165 patients enrolled into a 3-arm randomized controlled study at University of Cologne, Germany evaluating the intra-operative use of CytoSorb during open heart surgery, reported a statistically significant reduction in sternal wound inf
Slide 42: Post-op SIRS (Cardiac Surgery) Case Series
Post-op SIRS (Cardiac Surgery) Case Series A retrospective case series was recently published on 16 consecutive cardiac surgery patients who developed post-operative SIRS following prolonged cardiopulmonary bypass, with shock requiring vasopressors and acute kidney injury requiring hemofiltration 1
Slide 43: Advisory Board in Critical Care
Advisory Board in Critical Care John Kellum, MD (Chair) Mitchell Cohen, MD Raul Coimbra, MD, PhD Ronald Maier, MD University of Pittsburgh University of San Francisco University of San Diego University of Washington, Seattle Ernest Moore, MD Emil Paganini, MD Joseph Parrillo, MD Claudio Ronco, MD Un
Slide 44: 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 45: 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 46: 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
Slide 47: Septic Shock Series
Septic Shock Series • 8 patient case series: 2 severe sepsis, 6 septic shock • CytoSorb® used with continuous renal replacement therapy (CRRT) for 24 hours at a time, with a median treatment time of 2 days • Those that benefited showed an improvement in hemodynamics, with a rapid reduction of vasopr
Slide 48: Septic Shock and SIRS Case Series
Septic Shock and SIRS Case Series • 14 patient case series: Abdominal sepsis (29%), pneumonia (50%), pancreatitis (14%), other (7%) • Patients were critically-ill, with a mean APACHE II score of 37, predicting a mortality of > 85% in sepsis • Observed a pronounced 10-fold decrease in vasopressor req
Slide 49: Removal of Bilirubin
Removal of Bilirubin • The liver is a major detoxification organ • Patients with either chronic liver failure due to alcoholic cirrhosis, NASH, or viral hepatitis, as well as acute liver failure, due to infection, liver cancer, alcohol, poisoning, shock, and other causes will have high levels of unc
Slide 50: More Studies Underway
More Studies Underway • Broad clinical program in Europe with 58 investigator-initiated studies in various stages, including several that have completed and nearly half have started and/or are enrolling • These studies run the gamut from sepsis, cardiac surgery, post-operative inflammation, liver fa
Slide 51: Many Published Peer-Reviewed Articles
Many Published Peer-Reviewed Articles 51
Slide 52: CytoSorb Website – A Wealth of Info
CytoSorb Website – A Wealth of Info Visit us at www.cytosorb.com 52
Slide 53: The International CytoSorb Registry
The International CytoSorb® Registry 53 53
Slide 54: Visit CytoSorb.com for Case of the Week
Visit CytoSorb.com for Case of the Week • We have had excellent feedback from both physicians and investors on the many exciting case reports presented in the CytoSorb “Case of the Week” on the www.cytosorb.com website • These cases highlight the ongoing successes that clinicians continue to have as
Slide 55: Key Catalyst #3: Leverage Pipeline to Establish Strategic Partnerships
Key Catalyst #3: Leverage Pipeline to Establish Strategic Partnerships 55
Slide 56: 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 57: 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 57 verticals. We make no other representations to our relationship wi
Slide 58: Fresenius Medical Care Launched in May
Fresenius Medical Care Launched in May • 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 strateg
Slide 59: To Launch This Month
To Launch This Month • Entered into a multi-year partnership with Terumo Cardiovascular Group, a global leader in medical devices for cardiac and vascular surgery and leading cardiac surgery disposables company worldwide • Initial exclusive distribution of CytoSorb® in France, Denmark, Norway, Swede
Slide 60: Has Renewed Focus on CytoSorb
Has Renewed Focus on CytoSorb 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 • They have renewed their commitment to CytoSorb with its ow
Slide 61: Strong Technology Validation of CytoSorb
Strong Technology Validation of CytoSorb $18M in Grant 17,000 and Contract Human Treatments Funding and Growing 61
Slide 62: 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 63: Key Catalyst #4: Increase Investor Awareness
Key Catalyst #4: Increase Investor Awareness 63
Slide 64: NASDAQ Capital Market Listed
NASDAQ Capital Market Listed • Clean capital structure with good liquidity for investors 64
Slide 65: Included in Russell Microcap Index
Included in Russell Microcap Index June 2015 65
Slide 66: Increasing Media Coverage
Increasing Media Coverage 66
Slide 67: Increasing Analyst Coverage
Increasing Analyst Coverage 67
Slide 68: Newly Launched Corporate Website
Newly Launched Corporate Website Please visit us at www.cytosorbents.com 68
Slide 69: 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 70: NASDAQ: CTSO Contact
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com