CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Investor Presentation (February 2016)
55 slides from CytoSorbents's investor presentation, February 2016
Slide 1: CytoSorbents Corporation Investor Presentation
CytoSorbents Corporation NASDAQ: CTSO Working to Save Lives Through Blood Purification Investor Presentation February 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: Leadership Background
Leadership Background Phillip Chan, MD, PhD – Chief Executive Officer and President Internal Medicine physician with 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 inves
Slide 5: Severe Inflammation is Deadly in the ICU
Severe Inflammation is Deadly in the ICU Millions of people are admitted to the intensive care unit in hospitals worldwide each year with deadly inflammatory conditions Cancer Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Immunotherapy ~27M cases ~5M cases ~1.5M cases ~40M cases ~0.5M severe
Slide 6: Inflammation is Dangerous in Cardiac Surgery
Inflammation is Dangerous in Cardiac Surgery • ~1M Open Heart Surgeries in US and EU annually • Coronary artery bypass graft surgery • Valve repair or replacement • Heart or lung transplantation • Congenital defect repair • Aortic reconstruction • In complex cardiac surgeries, patients are on the he
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 • 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 for use in any situation where cytokines are elevated • Clinically proven to
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: CytoSorb Active in Cytokine Sweet Spot
® CytoSorb Active in Cytokine Sweet Spot Pancreatic Trypsin Toxic Shock Syndrome Toxin IL-18, Pancreatic Chymotrypsin IL-1a HMGB1 TNF-α monomer TGF-β TNF-α trimer IFN-γ monomer IL-1Ra IL-6 Pneumolysin toxin sFas ligand Pancreatic Lipase, Amylase MCP-1 IL-13 sTNFR Complement C5a IL-10 MCP-1 glycosyla
Slide 13: 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 14: 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 14
Slide 15: A New Immunomodulation Strategy to Control Severe Inflammation
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 16: Case Report: Toxic Shock Syndrome
Case Report: Toxic Shock Syndrome • Recently, a 3 year old, 38 pound girl was stung on her leg by an insect and became infected with Staph aureus • Despite antibiotics, her condition rapidly worsened and she developed a systemic inflammatory response syndrome with toxic shock syndrome and multiple o
Slide 17: ~$17 Million in US Government Support
~$17 Million in US 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 $1.15M SBIR contracts for trauma and burn injury research (2011-present)
Slide 18: Drive Usage and Sales Of CytoSorb
Drive Usage and Sales Of CytoSorb 18
Slide 19: CytoSorb An Excellent Business Model
CytoSorb® An Excellent Business Model • Huge market CytoSorb® is sold to hospitals and critical care physicians, targeting a “need to have” $20+ billion worldwide critical care opportunity addressing organ failure • Little to no competition • Critical care physicians understand the problem • It is a
Slide 20: Direct Sales: Germany, Austria, Switzerland
Direct Sales: Germany, Austria, Switzerland We are selling CytoSorb to most of the major university and public hospitals in Germany, Austria and Switzerland. The market in Germany alone is $1.0-1.5 billion 20
Slide 21: E.U. Approval Opens Global Distribution
E.U. Approval Opens Global Distribution Distributed in 32 countries including the Germany, UK, France, Italy, Netherlands, Turkey, Russia, India, Israel, Poland, Romania, Scandanavia, Denmark, Middle East, Vietnam, Australia and New Zealand covering 2.1 billion lives. Expanding to other EU countries
Slide 22: Quarterly Euro-Adjusted Product Sales
Quarterly “Euro-Adjusted” Product Sales $2,000,000 CytoSorb® "Euro Adjusted" Product Sales $1,800,000 $1,750,000 $1,600,000 Preliminary Actual Range $1,400,000 $1.4-1.6M $1,221,694 $1,200,000 $1,031,761 $1,000,000 $920,041 $871,150 $816,109 $800,000 $663,233 $600,000 $569,243 $400,000 $314,159 $176,
Slide 23: Product Sales Growth, Euro Adjusted
Product Sales Growth, “Euro Adjusted” $5,000,000 Trailing Twelve Month Product Sales $4,700,000 $4,500,000 Preliminary $4,000,000 $3,828,994 Actual Range Impact of Euro $3,639,061 $3.9-4.1M $3,500,000 $3,382,253 Reported Sales $3,135,387 $3,000,000 $2,578,396 $2,500,000 $2,000,000 $1,750,196 $1,500,
Slide 24: How This Can Get Big Quickly
How This Can Get Big Quickly • In Germany alone, there are ~154,000 cases of severe sepsis or septic shock each year. Here, we have: Established reimbursement Most of the major university and public hospitals as customers Significant key opinion leader support throughout the country Strong d
Slide 25: Geographic Expansion – A Growth Engine
Geographic Expansion – A Growth Engine Q1 2016 Start 131M people Estimated 2016 Start 25
Slide 26: 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 26
Slide 27: 2nd CytoSorb Germany User's Meeting
2nd CytoSorb Germany User’s Meeting 27
Slide 28: 1st International CytoSorb User's Meeting
1st International CytoSorb User’s Meeting 28
Slide 29: 2nd International CytoSorb User's Meeting
2nd International CytoSorb User’s Meeting 29
Slide 30: International Society of Intensive Care & Emergency Medicine – Brussels 2015
International Society of Intensive Care & Emergency Medicine – Brussels 2015 30
Slide 31: Drive the Data that will Make CytoSorb Standard of Care
Drive the Data that will Make CytoSorb Standard of Care 31
Slide 32: Robust Clinical Program and Team
Robust Clinical Program and Team Chief Medical Officer Cardiac Sepsis Trauma Surgery Advisory Advisory Advisory Board Board Board Director of Clinical Medical Director of European Statistician Operations Director Scientific Affairs 50+ Investigator Case Initiated Reports Studies International CytoSo
Slide 33: 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 34: REFRESH I Trial To Start in US
REFRESH I Trial To Start in US REduction in FREe Hemoglobin • 40-patient, eight-center feasibility study evaluating the safety of CytoSorb® intra- operatively in a bypass circuit in a heart-lung machine during complex cardiac surgery in elective, non-emergent surgery where the patient is expected to
Slide 35: REFRESH I Update
REFRESH I Update REduction in FREe Hemoglobin Trial • Working with major cardiac surgery centers in this trial • Baylor College of Medicine • Baystate Medical Center • Columbia University • Cooper University Hospital • University of Kentucky • University of Maryland • University of Pennsylvania • Un
Slide 36: Leading Advisors in Critical Care
Leading Advisors 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
Slide 37: Severe Sepsis or Septic Shock US Trial
Severe Sepsis or Septic Shock US Trial • Severe sepsis and septic shock are the overzealous immune response to a serious infection that can cause organ injury, organ failure and death • It is the largest, but also the most complex, critical care market, afflicting 27 million people worldwide, killin
Slide 38: Many Published Peer-Reviewed Articles
Many Published Peer-Reviewed Articles 38
Slide 39: CytoSorb Website – A Wealth of Info
CytoSorb Website – A Wealth of Info Visit us at www.cytosorb.com 39
Slide 40: International CytoSorb Registry
International CytoSorb Registry • The home of 50+ planned investigator initiated studies with many already enrolling 40
Slide 41: Leverage Pipeline to Establish Strategic Partnerships
Leverage Pipeline to Establish Strategic Partnerships 41
Slide 42: Fresenius Medical Care
Fresenius Medical Care • In December 2014, entered into a multi-year, 6 country partnership with Fresenius, the largest dialysis company in the world for exclusive distribution of CytoSorb® in critical care in France, Sweden, Norway, Finland, Denmark and Poland • CytoSorb® is a key part of Fresenius
Slide 43: Fresenius Launch Expected in Q1 2016
Fresenius Launch Expected in Q1 2016 • In 2015, we worked with Fresenius to complete all of the documentation, country registrations, certifications, development of marketing materials, and training needed for the launch • Fresenius is currently marketing the technology to critical care key opinion
Slide 44: Strategic Partnership: The Most Comprehensive Treatment for Sepsis
Strategic Partnership: The Most Comprehensive Treatment for Sepsis Treat the Primary Infection Treat the Massive Inflammatory Response • Biocon is the largest biotechnology company in India • Partnered with Biocon since late 2013 • Significantly growing usage in India with now expansion into Sri Lan
Slide 45: Cardiac Surgery Partner Update
Cardiac Surgery Partner Update • In November 2014, we established an initial partnership in France with one of the top 4 cardiac surgery companies in the world. The partner successfully completed its test evaluation of CytoSorb with one of the leading cardiac surgeons in France. • We are currently h
Slide 46: Beads Enable a Broad and Valuable Pipeline
Beads Enable a Broad and Valuable Pipeline ContrastSorb DrugSorb BetaSorb Critical Care, High Blood CT Imaging, Drug Overdose, Improving Risk Surgery Collection & Interventional Chemo Removal Dialysis Transfusion Radiology CE Mark Approved Under Development 46
Slide 47: Potential for More Strategic Partnerships
Potential for More Strategic Partnerships* 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 47 verticals. We make no other representations to our relationship with
Slide 48: Increase Investor Awareness
Increase Investor Awareness 48
Slide 49: NASDAQ Capital Market Listed
NASDAQ Capital Market Listed • Clean capital structure with good liquidity for investors 49
Slide 50: Added to the Russell Microcap Index
Added to the Russell Microcap Index June 2015 50
Slide 51: Increase Institutional Ownership
Increase Institutional Ownership Source: NASDAQ 51
Slide 52: Increase Analyst Coverage
Increase Analyst Coverage 52
Slide 53: Increase Media Coverage
Increase Media Coverage +Mi DEVICE bens inks deat with Fresenivs Medical Care (ink) By Mark Hollmer ‘Mass Devicr. ‘December 16, 2044 Fresenius Medical Care (S sated to isu purification Fikers 25 TeStteet rreetral countries 2s part of a Mel! strategic s cavsebnts § (oe cTS0) sad yesterday 8 thatit jc
Slide 54: CytoSorbents Has Tremendous Potential
CytoSorbents Has Tremendous Potential ® CytoSorb may help revolutionize critical care medicine, saving lives, and reducing costs • Massive untapped $20 billion unmet, medical need in critical care • CytoSorb® sales are generating significant growth with attractive 60+% gross margins • Continued geog
Slide 55: NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com