Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Rodman & Renshaw Presentation 2013
38 slides from Cytosorbents's conference presentation, Sep 13, 2013
Slide 1: Rodman & Renshaw Presentation
Rodman & Renshaw Presentation OTCBB: CTSO Dr. Phillip Chan, MD, PhD - CEO September 2013 Working to Save Lives Through Blood Purification Cyto Sorbents Corporation
Slide 2: Safe Harbor Statement
Cyto Sorbents TM Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiary CytoSorbents, Inc that are not historical facts are forward - looking statements and are subject to risks and uncertainties that could cause actual future events or
Slide 3: Company Overview
Cyto Sorbents TM Company Overview 3 CytoSorbents is an emerging growth opportunity aiming to revolutionize critical care medicine with a powerful blood purification technology called CytoSorb ® approved in the European Union The goal of CytoSorb ® is to prevent or treat organ failure – the leading c
Slide 4: The Technology
Cyto Sorbents TM The Technology 4 The underlying blood purification technology is based on biocompatible, highly porous polymer beads that act like tiny sponges to remove harmful substances from blood Protected by 32 issued US patents and multiple applications pending Manufactured at our ISO 134
Slide 5: Management Team
Cyto Sorbents TM Management Team 5 Phillip Chan, MD, PhD – Chief Executive Officer and President Board - certified Internist . 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 s
Slide 6: Leading Advisors in Critical Care
Cyto Sorbents TM 6 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 Pag
Slide 7: Strong Support From Major Organizations
Cyto Sorbents TM Strong Support From Major Organizations 7 DARPA awarded a $3.8 million 5 - year (2012) contract as part of its “Dialysis - Like Therapeutics” program to treat sepsis to remove cytokines and bacterial toxins U.S. Army awarded $1.15M in SBIR contracts for trauma and burn injury
Slide 8: Critical Care: A $10-15B Opportunity
Cyto Sorbents TM Critical Care: A $10 - 15B Opportunity 8 • Millions are afflicted each year in the US and Europe • If they survive the initial incident, “life support” can temporarily keep them alive, but does little to help them get better • The lack of “active” treatments for these serious life -
Slide 9: Organ Failure: Top Cause of Death
Cyto Sorbents TM Organ Failure: Top Cause of Death 9 Organ failure occurs when vital organs stop working, causing 50% of all deaths in the ICU, but little can be done to treat or prevent it today
Slide 10: Cytokine Storm Causes Organ Failure
Cyto Sorbents TM 10 10 Shock Clotting Cytokine Storm SIRS/Inflammation, Organ Failure and Infection Lung Injury Cell Death Renal Failure Immune Paralysis Cytokine Storm Causes Organ Failure
Slide 11: CytoSorb: Our Solution
Cyto Sorbents TM CytoSorb ® : Our Solution 11 • CytoSorb ® is the only specifically approved extracorporeal cytokine filter in the E.U. • Specifically targets the prevention or treatment of organ failure by reducing cytokine storm and controlling potentially deadly inflammation • Broad approved indi
Slide 12: How Is It Used?
Cyto Sorbents TM How Is It Used? 12 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 contact blood and remove unwanted or toxic s
Slide 13: Proven Broad Cytokine Reduction
Cyto Sorbents TM Proven Broad Cytokine Reduction 13 Achieved statistically significant 30 - 50% reduction in key cytokines across the 7 - day treatment period 49.1% reduction p=0.01 49.5% reduction p=0.002 36.5% reduction p=0.001 30.2% reduction p=0.002 N = 43: 18 treatment ( blue ); 25 control ( re
Slide 14: Used Successfully in Many Applications
Cyto Sorbents TM Sepsis ARDS Burns Trauma Surgery Pancreatitis Influenza Life Support Liver Failure 14 Used Successfully in Many Applications
Slide 15: Sepsis: A Top Ten Killer Worldwide
Cyto Sorbents TM Sepsis: A Top Ten Killer Worldwide 15 Sepsis is the result of an overzealous immune response to an infection and is driven by “cytokine storm” Afflicts 18 million people worldwide every year and growing Severe sepsis kills 1 in every 3 despite the best medical treatment Kill
Slide 16: CytoSorb Attacks Sepsis Broadly
Cyto Sorbents TM 16 Inflammatory cytokines (organ failure) Immunosuppressive cytokines (infection) Many bacterial toxins (organ failure) Directs the immune system where to go and where not to go (organ failure) No other single therapy has demonstrated this broad range of activity CytoSorb ® Attacks
Slide 17: Increased Survival in Patients with High Cytokines
Cyto Sorbents TM Increased Survival in Patients with High Cytokines 17 * Statistically significant 28 - day mortality benefit (0% vs 63% control, p=0.03, n=14) (IL - 6 ≥ 1,000 pg/mL or IL - 1ra ≥ 16,000 pg/mL) *
Slide 18: Commercialization of CytoSorb
Cyto Sorbents TM 18 Commercialization of Cyto Sorb ®
Slide 19: Commercial opportunity highlights
Cyto Sorbents TM 19 Huge market . CytoSorb ® is sold to hospitals and critical care physicians, targeting a “need to have” $ 10 - 15 billion critical care opportunity addressing organ failure Little competition . CytoSorb is the only specifically approved cytokine filter Critical care physicia
Slide 20: Step 1: Key Opinion Leader Support
Cyto Sorbents TM Step 1: Key Opinion Leader Support 20 ~100 KOLs Hospital Administration Product Ordering Clinical Trials Case Reports Papers Conferences Supporting Usage in Department Reimbursement 4 Sales People We launched CytoSorb® in 2H 2012 with a direct sales force of 4 people in Germany, Aus
Slide 21: Direct Territory KOL Coverage
Cyto Sorbents TM Direct Territory KOL Coverage 21 We are currently working with KOLs in the largest and most important university and public hospitals in most major cities in Germany and many in Austria and the United Kingdom Partial List: • University of Aachen • University of Bonn • Helios Berlin
Slide 22: Germany Alone Can Drive Success
Cyto Sorbents TM Germany Alone Can Drive Success 22 Third largest medical device market in the world We count the majority of the largest university and public hospitals in Germany as our current customers or soon to be customers/collaborators Strong KOL support with ongoing studies and growin
Slide 23: Step 2: Drive Departmental Usage
Cyto Sorbents TM Step 2: Drive Departmental Usage 23 Junior and Senior Physicians Nursing and Technical Staff We are starting this phase now Key Opinion Leader
Slide 24: Revenue Multiplier Effect
Cyto Sorbents TM Revenue Multiplier Effect 24 1,500 Junior and Senior Physicians 2,500 Nursing and Technical Staff ~100 KOLs 10 - 20 Sales & Support Staff $ Millions in sales $ Hundreds of thousands in sales
Slide 25: Step 3: Drive Clinical Data
Cyto Sorbents TM 25 Step 3: Drive Clinical Data 25 25 18 Investigator Initiated and Funded Studies European Pivotal Sepsis Trial US Pivotal Sepsis Trial European Registry US Air Force Funded Trauma Pilot Case Reports Germany Dosing Study 2013 2014 United States Studies European Studies: Dr. Rainer K
Slide 26: Step 4: Supplement with Distribution
Cyto Sorbents TM Step 4: Supplement with Distribution 26 Signed L.IN.C Medical (UK/Ireland) & Hitit Medical (Turkey). Expanding to other parts of Europe and other countries outside the EU that accept the CE Mark Middle East
Slide 27: Revenues
Cyto Sorbents TM Revenues 27 Focus has been on STEP 1: KOL awareness and adoption and STEP 3 & 4 Plan to accelerate sales by implementing STEP 2 Operating expenses have been significantly offset by grant income Direct Sales Distributor A Grant Income $0.00 $0.20 $0.40 $0.60 $0.80 $1.00 $1.20 $
Slide 28: Multiple Capital Sources to Fund Growth
Cyto Sorbents TM Multiple Capital Sources to Fund Growth Grant income: Targeting approximately $1M in milestones from existing grants in the remainder of 2013 Product Sales: With product gross margins expected to remain well above 50% increases in sales will help to directly offset operating exp
Slide 29: Competition: No Approved Therapies
Cyto Sorbents TM Competition 29 No Approved Therapies in the EU or US to Prevent or Treat Organ Failure Sepsis ARDS and ALI Burn injury Trauma Severe Acute Pancreatitis Cardiopulmonary bypass Complications of surgery Organ transplant Many others
Slide 30: Blood Purification for Sepsis: Competition
Cyto Sorbents TM Blood Purification for Sepsis: Competition 30 Criteria Cyto Sorb Septex Ultraflux CPFA PMMA AN69 ST Toraymyxin CytoPherx Manufacturer Cyto Sorbents Gambro Fresenius Bellco Toray Gambro Toray CytoPherx Used for sepsis treatment in EU? √ √ √ √ √ √ √ î Specific approval as a cytokine f
Slide 31: Platform Technology = Valuable Pipeline
Cyto Sorbents TM 31 Platform Technology = Valuable Pipeline Critical Care High Risk Surgery Drug Overdose Chemo Removal Blood Transfusion CT Imaging Interventional Radiology Contrast Sorb Drug Sorb Beta Sorb Improving Dialysis 31
Slide 32: HemoDefend: $750M-$1B Worldwide Market
Cyto Sorbents TM Reduce risk of TRALI and transfusion reactions by removing harmful contaminants from both pRBCs and platelets Keep “new” blood fresh “Wash blood” without time, expense, and logistics of traditional blood washing Awarded $200K Phase I SBIR grant from NHLBI/NIH validating appr
Slide 33: ContrastSorb For Imaging & Interventional Radiology
Cyto Sorbents TM Contrast Sorb For Imaging & Interventional Radiology • IV contrast, used for interventional radiology (IR) and imaging procedures can cause kidney failure particularly in high risk patients (e.g. diabetes, high blood pressure, others) • 65 million CT scans are performed worldwide ea
Slide 34: Strategic Partnerships – Key to Value
Cyto Sorbents TM Strategic Partnerships – Key to Value 34 Recently appointed Chris Cramer, MS, MBA as VP of Business Development. Former Senior Director of New Venture Development at J&J Many potential partners including companies in: Dialysis and renal therapies Pharmaceuticals Critical c
Slide 35: Potential Near Term Catalysts
Cyto Sorbents TM Potential Near Term Catalysts 35 Second Half First Half 2013 2014 Value Creation Increasing CytoSorb Revenue Strategic Partnership FDA meetings & trial planning New Clinical Data NASDAQ Uplisting New Product Announcements
Slide 36: Continued Positive Analyst Coverage
Cyto Sorbents TM 36 36 36 Continued Positive Analyst Coverage
Slide 37: Why Is CytoSorbents Attractive Now?
Cyto Sorbents TM Why Is CytoSorbents Attractive Now? 37 We are at the “ground floor” of commercialization, poised to create significant value with an approved product , Cyto Sorb ® , that may revolutionize critical care medicine, save lives, and reduce costs x Blockbuster potential: Massive market w
Slide 38: Please Contact Us
Cyto Sorbents TM Please Contact Us Phillip P. Chan, MD, PhD - CEO 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 pchan@cytosorbents.com Working to Save Lives Through Blood Purification OTCBB: CTSO Investor Contact Alliance Advisors, LLC Alan Sheinwald asheinwald@allianceadvisors.net Valter P