CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Needham Healthcare Conference 2015
52 slides from CytoSorbents's conference presentation, Apr 15, 2015
Slide 1: CytoSorbents Corporation: An Emerging Leader in Critical Care Immunotherapy
CytoSorbents Corporation NASDAQ: CTSO An Emerging Leader in Critical Care Immunotherapy Needham Healthcare Conference April 15, 2015
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 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: 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 5: 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 5
Slide 6: 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 7: $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 8: 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 9: 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 9
Slide 10: 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 11: 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 12: 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 13: 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 13
Slide 14: 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 15: 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 16: Cytokine Release Syndrome in Cancer Immunotherapy
Cytokine Release Syndrome in Cancer Immunotherapy One of the most promising and exciting areas of cancer research is where: 1) A patient’s own white blood cells (T-cells) are removed from the body 2) Modified with a gene for a chimeric antigen receptor (CAR) that enables it to recognize, proliferate
Slide 17: More Published Case Reports & Studies
More Published Case Reports & Studies 17
Slide 18: Launched International CytoSorb Registry
Launched International CytoSorb Registry • The home of 50+ planned investigator initiated studies with many already enrolling 18
Slide 19: Launched New CytoSorb Website
Launched New CytoSorb Website www.cytosorb.com 19
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: $7-8 per share • Average daily trading volume: 288K shares (~$2M daily trading value) • Market cap: ~$180M 22
Slide 23: 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 24: 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 25: 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 26: Rapidly-Growing Annual Product Sales
Rapidly-Growing Annual Product Sales $3,500,000 $3,135,387 CytoSorb® Product Sales $3,000,000 $600,000 $570,000 $2,500,000 CytoSorb® Product Sales $500,000 Quarter over quarter growth rate has averaged 65% in the last three quarters $2,000,000 $400,000 $314,159 $300,000 $1,500,000 $203,561 $176,098
Slide 27: Product Sales Trends Remains Positive
Product Sales Trends Remains Positive 27
Slide 28: Q1 2015 Revenue Guidance
Q1 2015 Revenue Guidance At this early stage of commercialization, investors should expect quarterly results to be “lumpy” reflecting the timing and size of bulk orders • Q1 2015 CytoSorb revenue guidance: $700 - 725K vs $569K Q1 2014 (~25%) • Adjusted for the 22% drop in the Euro since Q1 2014, sal
Slide 29: Balance Sheet and Cap Table
Balance Sheet and Cap Table Consolidated Balance Sheet Data: 12/31/2014 Cash and Short-Term Investments $ 5,549,827 * Total Assets $ 8,468,625 Total Debt $ - Total Shareholder's Equity $ 3,963,183 * * Does not relfect an additional $10.3M financing completed in January 2015. CytoSorbents Cap Table (
Slide 30: Investing in Growth: Catalysts for 2015-2016
Investing in Growth: Catalysts for 2015-2016 30
Slide 31: #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 50+ Post-Market Studies Generate Orders from Existing Distributors. targeting Junior and Se
Slide 32: 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. 32
Slide 33: 2nd CytoSorb Germany User's Meeting
2nd CytoSorb Germany User’s Meeting 33
Slide 34: 1st International CytoSorb User's Meeting
1st International CytoSorb User’s Meeting 34
Slide 35: ISICEM 2015
ISICEM 2015 ee CvtoSoriients Working to Save Lives Through Blood Purificatio!
Slide 36: #2: Target US FDA Approval
#2: Target US FDA Approval Sepsis and Critical Illness Cardiac Surgery Sepsis alone afflicts 2.5 One million open heart million people in the US surgeries performed in and EU annually without the US and EU each an approved therapy. year, representing a Critical care illnesses $500M-1 billion market
Slide 37: FDA Approval of IDE for REFRESH Study
FDA Approval of IDE for REFRESH Study • REFRESH (R Reduction in FREe FRE Hemoglobin) Trial is a 20-patient multi-center feasibility study evaluating the safety of CytoSorb® use intra-operatively in a bypass circuit in a heart-lung machine during complex cardiac surgery. The goal is the safe reductio
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: FDA Expedited Access Pathway (EAP)
FDA Expedited Access Pathway (EAP) The FDA has issued formal guidance on the EAP program that will facilitate the approval of medical devices that treat life-threatening conditions and fulfill the following criteria: 1) The medical device is intended to treat a life-threatening or irreversibly debil
Slide 40: Advantages of EAP Designation
Advantages of EAP Designation The first step is to submit an application to the FDA to request EAP Designation. If successful, this has a number of advantages: • CytoSorb® would be given priority status and be assigned an FDA case manager which would facilitate future discussions with the FDA • Vali
Slide 41: #3: Generation of Clinical Data
#3: Generation of Clinical Data Chief VP of Clinical Medical Development Officer Cardiac Sepsis Trauma Surgery Advisory Advisory Advisory Board Board Board Clinical Trial Manager Medical Director of European Statistician United States Trials Director Scientific Affairs 50+ Investigator European Case
Slide 42: #4: New Products and Strategic Partnerships
#4: New Products and Strategic Partnerships 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 the near term • Following a successful
Slide 48: #5: Increased Investor Awareness
#5: 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 60+% gross margins • Continued geog
Slide 52: CytoSorbents Corporation
CytoSorbents Corporation NASDAQ: 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