CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Q3 2013 Earnings Presentation
42 slides from CytoSorbents's earnings presentation, Nov 6, 2013
Slide 1: CytoSorbents Q3 2013 Earnings Review
CytoSorbents Corporation OTCBB: CTSO Q3 2013 Earnings Review November 6, 2013 Webcast replay with slides can be accessed at: http://public.viavid.com/player/index.php?id=106521 A transcript of the earnings call will be available shortly at www.sec.gov or on the Company website
Slide 2: Safe Harbor Statement
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 results to differ m
Slide 3: Conference Call Participants
Conference Call Participants Dr. Phillip Chan, MD, PhD Chief Executive Officer and President Vincent Capponi, MS Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Dr. Christian Steiner, MD Vice President of Sales and Marketing Christopher Cramer, MS, MBA Vice President of Busi
Slide 4: Overview
Overview med CVtOSorbents Working to Save Lives Through Blood Purification
Slide 5: CytoSorbents is a critical care focused company
CytoSorbents (OTCBB: CTSO) is a critical care focused company working to save lives by targeting uncontrolled inflammation through blood purification 5
Slide 6: Inflammation Plays a Major Role in Nearly Every Known Disease
Inflammation Plays a Major Role in Nearly Every Known Disease • Life threatening conditions like sepsis & trauma • Autoimmune diseases like rheumatoid arthritis, inflammatory bowel, psoriasis, and lupus • Heart disease, peripheral artery disease • Cancer, cancer cachexia, graft vs host disease • Neu
Slide 7: Severe Inflammation Drives Organ Failure
Severe Inflammation Drives Organ Failure Organ failure occurs when vital organs stop working, causing nearly half of all deaths in the ICU, but little can be done to treat or prevent it today 7
Slide 8: CytoSorb Removes the Fuel to the Fire
CytoSorb® Removes the Fuel to the Fire CytoSorb® is the only specifically approved extracorporeal cytokine filter in the E.U. Cytokines and other inflammatory mediators are the substances that drive inflammation Clinically proven to reduce key cytokines in blood by 30-50% in critically ill patients
Slide 9: CytoSorb Is A Powerful New Strategy to Control Severe Inflammation
CytoSorb Is A Powerful New 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 ablati
Slide 10: The Goal: Actively Prevent or Treat Organ Failure
The Goal: Actively Prevent or Treat Organ Failure in Many Life-Threatening Conditions Improve Decrease Patient Costs Of Outcome ICU and and Patient Survival Care Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical Critical Care: $10 - 15B Opportunity 10
Slide 11: The Heart of the Technology
The Heart of the 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 multiple applica
Slide 12: Our Bead Technology Enables a Versatile Product Portfolio
Our Bead Technology Enables a Versatile Product Portfolio 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 12
Slide 13: $15+ Million in US Government Support
$15+ Million in US Government Support • DARPA awarded $3.8M five year (2012) 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 (2011-13) • U.S. Air F
Slide 14: Q3 2013 Financial Highlights
Q3 2013 Financial Highlights 14
Slide 15: Third Quarter Key Financial Info
Third Quarter Key Financial Info (in thousands of U.S. Dollars) Three months ended Nine months ended September 30, September 30, 2013 2012 2013 2012 Product Sales $ 204 $ 14 $ 508 $ 64 Grant and other income 677 591 1,036 675 Total revenue $ 881 $ 605 $1,544 $ 739 EBITDA $(807 $(552) $(3,433) $(2,22
Slide 16: Strong Product Growth in Q3 2013
Strong Product Growth in Q3 2013 16
Slide 17: Product Sales
Product Sales $700,000 TTM Product Sales $600,000 $500,000 $400,000 $310,779 $300,000 $200,000 $100,000 $- Q4 2012 Q1 2013 Q2 2013 Q3 2013 7 CytoSorbents Working to Save Lives Through Blood Purification
Slide 18: Strong Gross Margins
Strong Gross Margins CytoSorbents currently has distributors in the • For the three months ended September 30, United Kingdom, Ireland, the Netherlands, and 2013 product gross margins were 71% Turkey plus a strategic partnership in India • Overall 2013 product gross margins were approximately 64% •
Slide 19: Working Capital
Working Capital Multiple Sources of Capital to Fund Growth • Grant income - continues to provide funding to offset operating costs • Product Sales – high gross margins and increasing sales will drive us closer to cash flow breakeven • Potential strategic partnerships • Raising capital through tradit
Slide 20: Q3 2013 Operational Highlights
Q3 2013 Operational Highlights 20
Slide 21: Focus is on Driving Departmental Usage
Focus is on Driving Departmental Usage Key Opinion Leader Junior and Senior Physicians Nursing and Technical Staff 21 21
Slide 22: Will Have A Number of Reference Sites Soon
Will Have A Number of Reference Sites Soon • 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 • Usage of CytoSorb® at many hospitals is increasing, both in the number of pat
Slide 23: Actively Expanding our Direct Sales Force
Actively Expanding our Direct Sales Force ~100 KOLs $ Hundreds of thousands in sales 2013 Target 7 sales reps & 1 clinical support specialist $ Millions in sales Many Junior and Senior Physicians Many Nursing and Technical Staff 23
Slide 24: Partnership with Biocon, The Largest Biotech in India
Partnership with Biocon The Largest Biotech in India On World Sepsis Day 2013, BioCon and CytoSorbents announced a strategic partnership with initial distribution in India and select emerging markets Biocon: $467M in 2013 revenue, targeting $1B with $18% CAGR 24 24
Slide 25: Biocon Antibiotics + CytoSorb: Most Comprehensive Treatment for Sepsis
Biocon Antibiotics + CytoSorb® The Most Comprehensive Treatment for Sepsis Treat the Primary Infection Treat the Massive Inflammatory Response India has 1.2 billion people with one in every 4 patients in the ICU has or develops sepsis in India Biocon expected to contribute to revenue growth for 2013
Slide 26: 26 Investigator Initiated Studies
26 Investigator Initiated Studies • Up from 18 last quarter Sepsis Trauma Burns • 3 have begun enrollment • Initial data expected in 1H 2014 Influenza Surgery ARDS Pancreatitis Life Support Kidney & Liver 26 Failure
Slide 27: CytoSorbents Case Reports
CytoSorbents Case Reports Mortality in patients with septic shock and Candida infection is 64% even with treatment1 46 year old woman with septic shock and documented Candida albicans infection of an IV port • Critically ill with septic shock multiple organ failure • Increasing vasopressor dependenc
Slide 28: CytoSorbents Case Reports
CytoSorbents Case Reports CVVHD CytoSorb 80 year old man with end-stage kidney failure on chronic hemodialysis with Type 2 diabetes • Septic shock due to Staphylococcus aureus pneumonia treated with ceftriaxone and clarithromycin • Despite antibiotics, continued to deteriorate • On Day 3, began Cyto
Slide 29: 37 year old patient with alcoholic liver cirrhosis
37 year old patient with alcoholic liver cirrhosis admitted to ICU because of multi-organ failure due to bilateral pneumonia with Staphylococcus aureus sepsis. Predicted mortality based on CLIF-SOFA score was >90% 27423 Underwent 4 consecutive CytoSorb® treatments, with hemodynamic stabilization and
Slide 30: Increased Presence at Major Conferences
Increased Presence at Major Conferences Exhibited • European Society of Intensive Care Medicine - ESICM 2013: Paris, France • 6th International Congress of the German Sepsis Society 2013: Weimar, Germany • American Association of Blood Banks - AABB 2013: Denver, Colorado • Cytokines 2013: San Franci
Slide 31: Prevention or Treatment of Organ Failure in Cardiac Surgery
Prevention or Treatment of Organ Failure in Cardiac Surgery 31
Slide 32: Cardiac Surgery Stats
Cardiac Surgery Stats Approximately 1MM Cardiopulmonary Bypass Surgeries in US and EU annually • Coronary artery bypass graft surgery • Open valve repair • Heart or lung transplantation Free Cytokine Storm Hemoglobin • Cardiac defect repair Patients often develop inflammation due to SIRS Vascular /
Slide 33: Simple, Rapid Implementation
Simple, Rapid Implementation CytoSorb is installed on cardiopulmonary bypass equipment within minutes and without needing another machine 33
Slide 34: CytoSorb Is Ideally Suited for CPB
® CytoSorb Is Ideally Suited for CPB • Effective removal of excess cytokines and free hemoglobin • Installs into CPB circuit easily and within minutes • Drop-in replacement for leukoreduction filters • Utilizes blood flow generated by the CPB circuit. No need for perfusionist to worry about another
Slide 35: Removal of Free Hemoglobin
Removal of Free Hemoglobin Removal of free hemoglobin from partially hemolyzed whole citrated bovine blood following incubation with 1:8 v/v CytoSorb beads (L to R: T0, 3, 18 h) at 12 rpm. Plasma fractions are shown following centrifugation. Hours of Incubation 35
Slide 36: Cardiac Surgery Is a Major Opportunity
Cardiac Surgery Is a Major Opportunity • Cardiac surgeons and patients both want zero complications • Although early, the initial experience with many cardiac surgery patients is very promising • Clinical trials can be done rapidly in this space • Represents a total addressable market >$500 million
Slide 37: $200K NHLBI SBIR Award for HemoDefend
$200K NHLBI SBIR Award for HemoDefend ™ • Collaborating with Dr. Larry Dumont, MD, MBA – Director of the Center for Transfusion Medicine Research and Associate Professor of Pathology at the Geisel School of Medicine at Dartmouth • The goal is to further develop and characterize the HemoDefend techno
Slide 38: Progress on Dosing Study
Progress on Dosing Study Goal: To determine the safety and preliminary efficacy of extended treatment to help inform the design of a U.S. pivotal sepsis trial • Enrollment has accelerated with a total of 8 clinical sites including: • University of Goettingen • Helios Erfurt • University of Aachen •
Slide 39: Proud Sponsor of World Sepsis Day and Sepsis Heroes
Proud Sponsor of World Sepsis Day and Sepsis Heroes A lot depends 39
Slide 40: Comments on Q4 2013
Comments on Q4 2013 • Seeing continued strong momentum of CytoSorb® sales into early Q4 2013 • Expecting record fiscal performance for all of 2013, our first full year of commercialization 40
Slide 41: Why Is CytoSorbents Attractive Now?
Why Is CytoSorbents Attractive Now? We are at the “ground floor” of commercialization, poised to create significant value with an approved product, CytoSorb , that may revolutionize critical care ® medicine, save lives, and reduce costs Blockbuster potential: Massive market with one of the biggest u
Slide 42: Question and Answer Session
Question and Answer Session Working to Save Lives Through Blood Purification OTCBB: CTSO Phillip P. Chan, MD, PhD - CEO Investor Contact 7 Deer Park Drive, Suite K Alliance Advisors, LLC Monmouth Junction, NJ 08852 Alan Sheinwald pchan@cytosorbents.com asheinwald@allianceadvisors.net Valter Pinto, v