Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (March 2016)
51 slides from Cytosorbents's investor presentation, March 2016
Slide 1: CytoSorbents Corporation Investor Presentation
CytoSorbents Corporation NASDAQ: CTSO Working to Save Lives Through Blood Purification Investor Presentation March 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: A Leader in Critical Care Immunotherapy
CytoSorbents: 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 • International footprint across two offices • Headquarters: Monmouth Junction, NJ • Administrative, ISO 13485 manufacturing, QA/QC, R&D • Sales Office: Berlin, Germany • Flagship product, CytoSorb® is E.U. approved, with distribution across 32 countries • Strategic Partners
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: Controlling Deadly Systemic Inflammation
Controlling Deadly Systemic Inflammation 6
Slide 7: 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 ~27M cases ~5M cases ~1.5M cases ~40M cases ~0.5M severe cases ~4M severe cases <1M an
Slide 8: Inflammation: Dangerous in Cardiac Surgery
Inflammation: 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 • Complex cardiac surgeries require extended surgical ti
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 • Required for proper immune system function • But in mild to moderate excess, cytokines can cause or exacerb
Slide 10: Massive Inflammation Causes Organ Failure
Massive Inflammation Causes Organ Failure Organ failure of vital organs leads to nearly half of all ICU deaths 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 • 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 12: Powerful Blood Purification Technology
Powerful Blood Purification Technology CytoSorb 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 multiple applications pending • Manufactu
Slide 13: CytoSorb: Plug and Play with Existing Machines
® CytoSorb : 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 machine found in hospitals worldwide Pump blood out of the body and through the cartridge Pol
Slide 14: 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 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: Goal: Prevent or Treat Organ Failure
Goal: Prevent or Treat Organ Failure Improve Decrease Patient Cost Of Outcomes ICU and And Patient Survival Care Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical The Potential to Revolutionize Critical Care Medicine 16
Slide 17: A New Immunomodulation Strategy to Control Severe Inflammation
CytoSorb: 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 system
Slide 18: 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 19: ~$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 ~$1.2M SBIR contracts for trauma and burn injury research (2011-present)
Slide 20: Drive CytoSorb Adoption
Drive CytoSorb Adoption med CVtOSorbents forking to Save Lives Through Blood Purification
Slide 21: CytoSorb: An Excellent Business Model
CytoSorb® An Excellent Business Model • Huge market Sold to hospitals & critical care doctors. Targets “need to have” life-or-death scenarios • Little to no competition • Critical care physicians understand the problem • Plug and play, high margin, disposable “razorblade” Hospital’s existing hemodia
Slide 22: 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 23: E.U. Approval Opens Global Distribution
E.U. Approval Opens Global Distribution Distributed in 32 countries covering 2.1 billion lives. Expanding to other EU countries and countries outside the EU that accept CE Mark WMC IntensivMed Australia and New Zealand 23
Slide 24: Quarterly Euro-Adjusted Product Sales
Quarterly “Euro-Adjusted” Product Sales $2,000,000 CytoSorb® "Euro Adjusted" Product Sales $1,800,000 $1,723,464 $1,600,000 $1,400,000 1,221,694 $1,200,000 $1,031,761 $1,000,000 $920,041 $871,150 $816,109 $800,000 $663,233 $569,243 $600,000 $400,000 $314,159 $176,098 $203,561 $200,000 $87,960 $127,9
Slide 25: Quarterly Euro-Adjusted Product Sales
Quarterly “Euro-Adjusted” Product Sales $2,000,000 CytoSorb® "Euro Adjusted" Product Sales $1,800,000 $1,723,464 $1,600,000 $1,400,000 1,221,694 $1,200,000 $1,031,761 $1,000,000 $920,041 $871,150 $816,109 $800,000 $663,233 $569,243 $600,000 $400,000 $314,159 $176,098 $203,561 $200,000 $87,960 $127,9
Slide 26: Product Sales Growth, Euro Adjusted
Product Sales Growth, “Euro Adjusted” $5,000,000 Trailing Twelve Month Product Sales $4,681,308 $4,500,000 $4,000,000 $3,828,994 Impact of Euro $3,639,061 $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 $1,500,000 $1,214,932 $1,000,000 $821,787
Slide 27: Potential for Growth Acceleration
Potential for Growth Acceleration • In Germany alone, there are ~154,000 cases of severe sepsis or septic shock each year. Here, we have: Established reimbursement Customers including majority of major university and many public hospitals Significant key opinion leader support Strong direct
Slide 28: 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 28
Slide 29: Drive Clinical Data to Support CytoSorb As Standard of Care
Drive Clinical Data to Support CytoSorb As Standard of Care 29
Slide 30: 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 31: 3rd International CytoSorb Users Meeting
3rd International CytoSorb Users Meeting • CytoSorbents will host its 3rd International CytoSorb Users Meeting in Brussels, Belgium on March 14, 2016 • Currently, more than 100 people are registered to attend the meeting from a total of 22 countries • Agenda includes 12 clinical and pre-clinical pre
Slide 32: 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 33: REFRESH I Trial Update
REFRESH I Trial Update 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 reconstruction, CABG redos,
Slide 34: REFRESH I Trial Update
REFRESH I Trial Update REduction in FREe Hemoglobin Trial • Working with major cardiac surgery centers • Baylor College of Medicine • Baystate Medical Center • Columbia University • Cooper University Hospital • University of Kentucky • University of Maryland • University of Pennsylvania • University
Slide 35: 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 36: U.S. Trial for Severe Sepsis or Septic Shock
U.S. Trial for Severe Sepsis or 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; 27 million people afflicted worldwide each year, estimated 9 mill
Slide 37: 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 38: Leverage Pipeline to Establish Strategic Partnerships
Leverage Pipeline to Establish Strategic Partnerships 38
Slide 39: Fresenius Medical Care Partnership
Fresenius Medical Care Partnership • Entered into 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 40: Fresenius Medical Care and ISICEM
Fresenius Medical Care and ISICEM • Fresenius will initiate the marketing push behind CytoSorb® at the International Symposium of Intensive Care and Emergency Medicine (ISICEM) Conference in Brussels, Belgium next week ahead of a forthcoming launch • CytoSorb® will be featured in the Fresenius exhib
Slide 41: Strategic Partnership: Creating the Most Comprehensive Treatment for Sepsis
Strategic Partnership: Creating the Most Comprehensive Treatment for Sepsis Treat Primary Infection with Treat Massive Antibiotics Inflammatory Response • Biocon is the largest biotechnology company in India • Partnership formed in late 2013 • Significantly growth in India with expansion into Sri La
Slide 42: Cardiac Surgery Partner Update
Cardiac Surgery Partner Update • Established partnership in France with a top 4 global cardiac surgery company • Key clinical data from the cardiac surgery evaluation study led by Prof. Christophe Baufreton, MD, PhD, cardiothoracic surgeon and Vice Dean of Research from C.H.U - Angers, France, in a
Slide 43: Polymer Beads: Broad and Valuable Pipeline
Polymer Beads: 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 43
Slide 44: Increase Investor Awareness
Increase Investor Awareness 44
Slide 45: NASDAQ Capital Market Listed
NASDAQ Capital Market Listed • Clean capital structure with good liquidity for investors 45
Slide 46: Added to Russell Microcap Index
Added to Russell Microcap Index June 2015 46
Slide 47: Increase Institutional Ownership
Increase Institutional Ownership Source: NASDAQ 47
Slide 48: Increase Analyst Coverage
Increase Analyst Coverage 48
Slide 49: Build Momentum in Key Media
Build Momentum in Key Media 49
Slide 50: CytoSorbents Investment Summary
CytoSorbents Investment Summary CytoSorbents is a hybrid: Combines the greater visibility and lower risk of a medical device company with product sales with the upside potential of a biotech • Massive untapped $20 billion unmet, medical need in critical care • Generating significant CytoSorb® sales
Slide 51: Contact: Dr. Phillip Chan, CEO
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO [email protected]