CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Investor Presentation (February 2015)
52 slides from CytoSorbents's investor presentation, February 2015
Slide 1: CytoSorbents Corporation: An Emerging Leader in Critical Care Immunotherapy
CytoSorbents Corporation NASDAQ CM: CTSO An Emerging Leader in Critical Care Immunotherapy Investor Presentation February 2015
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiaries CytoSorbents, Inc (now known as CytoSorbents Medical Inc) and CytoSorbents Europe GmbH that are not historical facts are forward-looking statements and are subject to risks and unc
Slide 3: CytoSorbents is An Emerging Leader in Critical Care Immunotherapy
CytoSorbents is An Emerging Leader in Critical Care Immunotherapy Leading the Prevention or Treatment of Life-Threatening Inflammation in the ICU using CytoSorb® Blood Purification 3
Slide 4: Overview
Overview • $20+ Billion opportunity with compelling CytoSorb® blood purification technology that targets reduction in deadly inflammation in many life-threatening illnesses in the ICU and during cardiac surgery • Strong international commercial growth based on EU approval with a profitable “Plug and
Slide 5: Management Team
Management Team 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 investments
Slide 6: Immune System Balance is Important
Immune System Balance is Important Healthy Response to Injury and Infection LOW NORMAL IMMUNE RESPONSE HIGH Immune Suppression Allergy/Asthma/Anaphylaxis Infection Autoimmune Disease Cancer Sepsis/SIRS Poor healing Organ Failure 6
Slide 7: Immunotherapy: $100+ Billion in Sales
Immunotherapy: $100+ Billion in Sales LOW NORMAL IMMUNE RESPONSE HIGH Activate the Immune Response Suppress the Immune Response • Vaccines ($30B+ revenue) • Antihistamines/Steroids ($20B+ revenue) • Sanofi, Merck, GSK, Pfizer, Novartis • Zyrtec, Claritin, Allegra, Advair, Singulair • Cancer Immunoth
Slide 8: $20 Billion Opportunity in Critical Care
$20 Billion Opportunity in Critical Care Millions of people are admitted to the intensive care unit in hospitals in the U.S. and the European Union each year with deadly inflammatory conditions Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical • In these conditions, little exists to red
Slide 9: 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 10: 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. ICU Little can be done to prevent or treat it today 10
Slide 11: CytoSorb Removes the Fuel to the Fire
CytoSorb® Removes the Fuel to the Fire • CytoSorb® represents a powerful immunotherapy to control inflammation • Approved in the European Union as the only specifically approved cytokine filter • Clinically proven to remove key cytokines in the blood of critically-ill patients • Approved for use in
Slide 12: The Heart of the Technology
The Heart of the Technology The underlying blood purification technology is based on state-of-the-art 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
Slide 13: How Is It Used?
How Is It Used? Plug and Play Compatible with a Hospital’s Existing Infrastructure 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 conta
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: Case Report: Toxic Shock Syndrome
Case Report: Toxic Shock Syndrome * • 17 year old man suffered an injury to his ankle and unexpectedly began to develop fever • He rapidly deteriorated and was hospitalized the next day at a major hospital in Rotterdam, Netherlands where antibiotics were started immediately. He continued to decline
Slide 16: Case Report: Influenza
Case Report: Influenza 56 year old man with documented swine (H1N1) influenza with multiple organ failure. Interferon levels were undetectable Treatment day 1 2 3 4 5 6 7 IL-6 (before) 8,076 1,025 527 172 117 120 107 pg/mL IL-6 (after) pg/mL 2,621 663 289 76 110 111 94 IL-6 (% change) -68% -35% -45%
Slide 17: More Published Case Reports
More Published Case Reports 17
Slide 18: Launched International CytoSorb Registry
Launched International CytoSorb Registry • The home of 40+ planned investigator initiated studies with many already enrolling 18
Slide 19: Leading Advisors in Critical Care
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 Cleveland
Slide 20: $15+ Million in US Government Support
$15+ 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 21: Operating and Financial Highlights
Operating and Financial Highlights 21
Slide 22: NASDAQ Capital Market Listed
NASDAQ Capital Market Listed CytoSorbents (CTSO) Up-listed to NASDAQ in December 2014 • Current Stock Price: $8.00 • Average daily trading volume: 157K shares ($1.25M daily trading value) • Fully-diluted market cap: ~$225M 22
Slide 23: #11 on Forbes Best Performing Stocks of 2014
#11 on Forbes Best Performing Stocks of 2014 CytoSorbents Achieved Strong Stock Performance in 2014 comparing favorably to peers 23
Slide 24: 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 25: Direct Sales: Germany, Austria, Switzerland
Direct Sales: Germany, Austria, Switzerland We are currently working with 150+ KOLs in the largest and most important university and public hospitals in most major cities in these countries Partial List: • University of Munich • Bergmannstrost Halle • Helios Berlin Buch • Charite Mitte and Charite V
Slide 26: E.U. Approval Opens Global Distribution
E.U. Approval Opens Global Distribution Distributed in 29 countries including the UK, France, Italy, Ireland, Netherlands, Turkey, Russia, India, Taiwan, Poland, Romania, Scandanavia, Denmark, and Middle East covering ~1.8 billion lives. Expanding to other EU countries and countries outside the EU t
Slide 27: Continuing Strong Product Growth
Continuing Strong Product Growth $1,200,000 CytoSorb® Product Sales $1,031,761 $1,000,000 Quarterly year over year growth has been excellent $800,000 $663,233 $569,243 $600,000 $400,000 $314,159 $203,561 $176,098 $200,000 $127,969 $87,960 $13,679 $0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2012 2012 2013 2013 201
Slide 28: Product Sales (TTM)
Product Sales (TTM) Trailing 12-month CytoSorb sales are $2.6M 28
Slide 29: Investing in Growth: Catalysts for 2015-2016
Investing in Growth: Catalysts for 2015-2016 29
Slide 30: #1: Core Focus on CytoSorb Sales
#1: Core Focus on CytoSorb® Sales Working with KOLs worldwide Strong Direct Sales Team with Reference Hospitals with Expansion Distributor Support to MICU, SICU, CICU, Trauma ICU Driving Departmental Adoption 40+ Post-Market Studies Generate Orders from Existing Distributors. targeting Junior and Se
Slide 31: Targeting Significant Revenue Acceleration
Targeting Significant Revenue Acceleration $M: 2015 Sales and Beyond Revenue Multiplying Effect 2014 Sales * Number of cartridges used only to graphically demonstrate the multiplier effect concept. This does not reflect revenue guidance for 2015. 31
Slide 32: #2: Target US FDA Approval Intra-Operative Cardiac Surgery
#2: Target US FDA Approval Intra-Operative Cardiac Surgery 32
Slide 33: Market Pull from Key Applications
“Market Pull” from Key Applications Sepsis Cardiac Surgery Use of CytoSorb either during or after Afflicts 2.5 million cardiac surgery to prevent organ dysfunction people in the US and and organ failure is a $500M – 1B total EU annually without addressable market in the US and EU alone an approved t
Slide 34: Cardiac Surgery Generates Inflammation
Cardiac Surgery Generates Inflammation ~1M Cardiac Surgeries requiring cardiopulmonary bypass in US and EU annually • Coronary artery bypass graft surgery • Open valve repair, cardiac defect repair Cytokine Storm & • Heart or lung transplantation Free Hemoglobin Complement • LVAD implantation Activa
Slide 35: Simple, Rapid Implementation on HLM
Simple, Rapid Implementation on HLM CytoSorb is platform independent and can be installed in a bypass circuit in a standard heart-lung machine within minutes and without the need for another machine 35
Slide 36: Intra-op Usage Reduces Post-op Inflammation
Intra-op Usage Reduces Post-op Inflammation Retrospective 40 patient cardiac surgery study • 20 patient (with CytoSorb) vs 20 patient (without CytoSorb) used intra-operatively with heart-lung machine • Patients underwent high risk surgery with hypothermic cardiac arrest and anterograde cerebral perf
Slide 37: U.S. Cardiac Surgery Pilot Study
U.S. Cardiac Surgery Pilot Study Represents the first part of a larger clinical trial strategy intended to support the U.S. approval of CytoSorb for intra-operative use during cardiac surgery Cardiac Surgery IDE Application Approved by the FDA in January 2015 1) CytoSorb Cardiac Surgery Pilot Study
Slide 38: Leading Advisors in Cardiac Surgery
Leading 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. Crai
Slide 39: #3: Generation of Clinical Data
#3: Generation of Clinical Data 39
Slide 40: Drive Clinical Studies in US and Abroad
Drive Clinical Studies in US and Abroad Chief VP of Clinical Medical Development Officer Cardiac Sepsis Trauma Surgery Advisory Advisory Advisory Board Board Board Director of European Clinical Trial Manager Statistician Medical Director Scientific Affairs United States Trials European Trials US Air
Slide 41: #3: New Products and Strategic Partnerships
#3: New Products and Strategic Partnerships 41
Slide 42: Our Bead Technology Enables a Diverse and Valuable Pipeline
Our Bead Technology Enables a Diverse 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 42
Slide 43: Potential for Strategic Partnerships
Potential for 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 43 verticals. We make no other representations to our relationship with any
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 Ms. Kiran Shaw, Chairman and Managing Director of Biocon, India’s largest biotechnology company – Year End 2014 earnings report about CytoSorb: “Excellent key opinio
Slide 45: Expansion of Biocon Partnership
Expansion of Biocon Partnership • According to Biocon, hundreds of patients have benefited from CytoSorb® therapy and orders continue to increase • Expanded agreement beyond sepsis to all critical care applications and cardiac surgery with a focus on the systemic inflammatory response syndrome (SIRS
Slide 46: Fresenius Medical Care
Fresenius Medical Care • Entered into a 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 • Leveraging Fresenius’ #1 or #2 position in critical care in these
Slide 47: Cardiac Surgery Initial Partnership
Cardiac Surgery Initial Partnership • Entered into an initial partnership with a top-four global medical device company in cardiac surgery to use CytoSorb® intra-operatively during cardiac surgery in France • Initial evaluation phase expected to be complete in Q2 2015 • Following a successful evalua
Slide 48: #4: Increased Investor Awareness
#4: Increased Investor Awareness 48
Slide 49: Continued Positive Analyst Coverage and Investor Outreach
Continued Positive Analyst Coverage and Investor Outreach 49
Slide 50: Increased Media Coverage
Increased Media Coverage +MASS cytoSorbents inks deal with Fresenius Medical Care (link) By Mark Holmer Mass Device December 16, 2014 MEDICAL DEVICE DAILY" THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE People in the News Medical Device Daily December 24, 2014 Fresenius Medical Care IS slated to distribut
Slide 51: 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 65% gross margins • Continued geogr
Slide 52: CytoSorbents Corporation NASDAQ CM: CTSO
CytoSorbents Corporation NASDAQ CM: CTSO Phillip P. Chan, MD, PhD - CEO 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 pchan@cytosorbents.com The Rise of An Emerging Critical Care Immunotherapy Company 52