Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (September 2021)
53 slides from Cytosorbents's investor presentation, September 2021
Slide 1: Investor Presentation September 2021
HELPING TO TREAT INFLAMMATION AND DEADLY CONDITIONS IN INTENSIVE CARE AND CARDIAC SURGERY NASDAQ: CTSO Investor Presentation September 2021
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future re
Slide 3: CytoSorbents
CytoSorbents Leading the Prevention or Treatment of Life-Threatening Inflammation and Cytokine Storm and other Deadly Conditions in Intensive Care and Cardiac Surgery using Blood Purification 3
Slide 4: CytoSorbents At a Glance (NASDAQ: CTSO)
CytoSorbents At a Glance (NASDAQ: CTSO) • CytoSorbents is a rapidly growing international NASDAQ-traded medical device company: ~210 employees, $43.3M in TTM product sales & $65.6M in cash (6/30/21) • CytoSorb® is E.U. approved and commercialized in 68 countries as an extracorporeal cytokine adsorbe
Slide 5: Products and Product Pipeline
Products and Product Pipeline Internal development supplemented by strong government support with ~$40M in grants, contracts, other non-dilutive funds awarded to date for our technology from DARPA, NIH, NHLBI, U.S. Army, U.S. Air Force, HHS, and others Sepsis, Critical Care, Removal of High Risk Ant
Slide 6: What does CytoSorb do and how does it work?
What does CytoSorb do and how does it work? 6
Slide 7: Targets Deadly Conditions That Afflict Millions of People
Targets Deadly Conditions That Afflict Millions of People Critical Care Cardiothoracic Surgery Uncontrolled inflammation can spiral out of Highly invasive, with major risk of bleeding, control, leading to failure of vital organs shock, severe inflammation, infection, sepsis, and death and others Sep
Slide 8: A Powerful New Approach to Controlling Inflammation
A Powerful New Approach to Controlling Inflammation CytoSorb has been used and well-tolerated in more than 143,000 cumulative treatments as a way to treat cytokine storm and reduce the “fuel to the fire” of inflammation Immunosuppressive Anti-Inflammatory (too strong) (too weak) Corticosteroids NSAI
Slide 9: Patented Blood Purification Technology
Patented Blood Purification 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 . • Proprietary patented technology with 18 iss
Slide 10: CytoSorb is "Plug and Play" Compatible
CytoSorb is “Plug and Play” Compatible Compatible with Existing Blood Pump Infrastructure In Hospitals Today Dialysis or CRRT ECMO (Continuous Renal Replacement Therapy) (Extracorporeal Membrane Oxygenation) Hemoperfusion CPB (Standalone Treatment) (Cardiopulmonary Bypass) 10
Slide 11: What is the Company's business model, financial performance and clinical development program?
What is the Company’s business model, financial performance and clinical development program? 11
Slide 12: CytoSorbents Has a Strong Hybrid Sales Model
CytoSorbents Has a Strong Hybrid Sales Model 68 Countries Worldwide and >143,000 devices shipped Critical Care and Cardiac Surgery Direct Sales Distributor and Partner Sales Direct sales in 10 countries: Distributor and Partner sales in 58 other countries Germany, Austria, Switzerland, Belgium, Ente
Slide 13: CytoSorb Commercialization Focus
CytoSorb Commercialization Focus By Market By Geography Other Critical Care – 17% • ARDS • Reversal of Shock 32% Distributor / Partner • Trauma 17% Critical Care 67% • Austria • Acute Liver / Pancreatic 17% Other Direct • Switzerland • Many Others Sepsis • 7 other Cardiac Surgery – 33% countries and
Slide 14: CytoSorb is a High Margin "Razorblade"
CytoSorb is a High Margin “Razorblade” • High margin “razorblade” fully compatible with existing installed base of “razor” blood pumps: Dialysis, CRRT, and ECMO machines (ICU), and heart-lung machines (OR) • Blended gross margins were 82% in Q2 2021, driven by volume production from our new manufact
Slide 15: Quarterly Product Sales
Quarterly Product Sales Q2 2021 product sales were among our best, up 19% from a year ago. Excluding COVID-19 sales, core product sales were a record $9.7M, +38% Y-Y $12.0 Product Sales $11.4M $2.5 $1.7 Core Non-COVID-19 Product Sales COVID-19 Sales $10.0 $2.7 $1.8 $9.7 $2.4 $9.0 $8.0 $8.3 $1.7 $7.5
Slide 16: TTM Product Sales & Blended Gross Margins
TTM Product Sales & Blended Gross Margins $50.0 85% $45.0 $43.3 $40.0 80% $35.0 PRODUCT GM % $30.0 $ IN MILLIONS $30.0 75% $25.0 $21.0 $20.0 $17.4 70% $15.0 $10.4 $10.0 $6.0 65% $5.0 $3.4 $0.0 60% Q2 2015 Q2 2016 Q2 2017 Q2 2018 Q2 2019 Q2 2020 Q2 2021 Product Sales Blended Gross Margin, adjusted fo
Slide 17: Clinical Development – Rich in 2021 Milestones
Clinical Development – Rich in 2021 Milestones Complementary approach to data generation: RCTs, Registries, Single-arm trials 2021 Q1 Q2 Q3 Q4 STAR-T IDE Submission & Operational RCT Protocol FPI Enrollment Full FDA Approval Readiness Cardiovascular REFRESH II Protocol Study Resumption Activities FP
Slide 18: What are the catalysts for growth?
What are the catalysts for growth? 18
Slide 19: Strategy For Continued High Margin Growth
Strategy For Continued High Margin Growth New Clinical Data Direct Sales New and Existing Applications Global Expansion Scaled Manufacturing 19
Slide 20: COVID-19 Accelerates World Adoption
COVID-19 Accelerates World Adoption • COVID-19 has put a spotlight on CytoSorb as a broad spectrum treatment of complications of uncontrolled, severe hyperinflammation, such as ARDS, shock, and kidney failure, caused by cytokine storm and other factors • CytoSorb has been used to treat >6,500 critic
Slide 21: Expanding Manufacturing Capacity to $300-400M
Expanding Manufacturing Capacity to $300-400M • Our current manufacturing facility has capacity for ~$80M in sales • Lead time to build out, qualify, and validate is approximately 2 years • We are currently building out our new headquarters in Princeton, NJ which will house our new manufacturing fac
Slide 22: Doubled Workforce to 210+
Doubled Workforce to 210+ Increased headcount focused heavily on commercialization and manufacturing to drive growth June 2021 November 2018 22
Slide 23: Direct Sales Focus on Germany
Direct Sales Focus on Germany • Germany is the largest medical device market in the E.U. and the third largest in the world. The German market alone represents a $1.0-1.5 billion total addressable market for CytoSorb • CytoSorb has a strong foundation for growth in Germany • Outstanding sales team,
Slide 24: Catalyzing CytoSorb Sales in Germany
Catalyzing CytoSorb Sales in Germany • In 2020, Germany accounted for ~50% of our overall product sales. Have now sub-divided Germany to shrink territories to allow maximization of revenue opportunity. Enables focus and growth of key accounts, increased efficiency due to shorter travel, and ability
Slide 25: EU Approval to Remove Ticagrelor and Rivaroxaban During Cardiothoracic Surgery
EU Approval to Remove Ticagrelor and Rivaroxaban “Blood Thinners” During Cardiothoracic Surgery CytoSorb has received E.U. approval to remove two well-known blockbuster “blood thinners” during cardiothoracic surgery, used in millions of patients to reduce risk of stroke and heart attacks Ticagrelor
Slide 26: REMOVE Endocarditis Trial To Read Out Shortly
REMOVE Endocarditis Trial To Read Out Shortly • Infective endocarditis (heart valve infection) occurs when bacteria seeds a heart valve from IV drug abuse and dirty needles, or from dental procedures • The incidence of endocarditis is rising in the U.S. due to the opiate crisis and use of dirty need
Slide 27: Liver Disease: Another Big Opportunity
Liver Disease: Another Big Opportunity • 850 million people suffer from chronic liver disease due to viral hepatitis, alcoholism, and non-alcoholic fatty liver (NASH), and other causes leading to 1 million deaths from chronic liver disease, and another 1 million from hepatic cancer • Millions of chr
Slide 28: CytoSorb + ECMO: Novel Lung Rest Strategy to Treat ARDS
CytoSorb + ECMO: Novel Lung Rest Strategy to Treat ARDS CytoSorb, in combination with extracorporeal membrane oxygenation (ECMO), represents a novel and potentially effective lung resting or lung preservation strategy to treat acute respiratory distress syndrome (ARDS) by providing gas exchange and
Slide 29: CytoSorb: Pneumogenic Sepsis, ARDS & ECMO
CytoSorb: Pneumogenic Sepsis, ARDS & ECMO • 13 patient prospective study (vs. No CytoSorb historical control; n=7) • Pneumogenic sepsis (3 influenza, 1 fungal, 9 bacterial) • ARDS and vv-ECMO treated with CytoSorb • Shock with norepinephrine > 0.3 μg/kg/min, lactate > 2.0 mmol/L; PCT > 1 ng/ml All p
Slide 30: CytoSorb: Pneumogenic Sepsis, ARDS & ECMO
CytoSorb: Pneumogenic Sepsis, ARDS & ECMO • Use of CytoSorb was rapid: within 6 hours of ICU admission and 12 hours of sepsis diagnosis • CytoSorb use resulted in rapid hemodynamic stabilization • Mean duration of ECMO: CytoSorb: 8±2 days (range 2-23 days) versus 19±3 days (range 13-30 days). Mean t
Slide 31: Unlocking the U.S. Opportunity
Unlocking the U.S. Opportunity STAR-T and REFRESH 2-AKI STAR-D Pivotal Trial Pivotal Trials 31
Slide 32: CytoSorb is FDA Emergency Use Authorized
CytoSorb is FDA Emergency Use Authorized CytoSorb is an extracorporeal cytokine adsorber that has been granted FDA Emergency Use Authorization (EUA) in the COVID-19 Pandemic Under the EUA*, CytoSorbents can make CytoSorb available, through commercial sales, to all hospitals in the United States for
Slide 33: Global COVID-19 CytoSorb Activity
Global COVID-19 CytoSorb Activity CytoSorb has been used in ~6,500 COVID-19 Patients in 30+ countries. As an E.U. approved extracorporeal cytokine adsorber, more than 143,000 treatments have been delivered to date CAN – Medical Device Authorization 33
Slide 34: CytoSorb Therapy in COVID-19 (CTC) Patients on ECMO: A Multicenter U.S. Registry
CytoSorb Therapy in COVID-19 (CTC) Patients on Extracorporeal Membrane Oxygenation (ECMO): A Multicenter U.S. Registry ClinicalTrials.gov: NCT04391920 34
Slide 35: Lung Rest is the Goal of CytoSorb + ECMO
Lung Rest is the Goal of CytoSorb + ECMO • SARS-CoV2 causes extensive lung injury that triggers inflammation • Severe inflammation is associated with more severe COVID-19 illness and risk of death • Inflammation is mediated by a wide range of inflammatory toxins that can lead to 2 types of ARDS: Hyp
Slide 36: U.S. CTC Multicenter Registry Overview
U.S. CTC Multicenter Registry Overview Critically Ill COVID-19 patients that require ECMO for refractory respiratory failure are among the sickest patients with the highest risk of death • Design: Multi-center, observational registry for patients treated under FDA EUA • Number of patients: 52 consec
Slide 37: CTC Registry Demographics and Baseline Characteristics
CTC Registry Demographics and Baseline Characteristics International ELSO ECMO COVID-19 Registry data referenced for contextualization Baseline CTC Registry ELSO Registry Characteristics ECMO cohort ECMO cohort (n= 52)1 (n=4382)2 Male 65% (34/52) 73% (3208/4382) Female 35% (18/52) 27% (1172/4382) Ag
Slide 38: 73% ICU Survival is Promising at 90 days
73% ICU Survival is Promising at 90 days 30 day mortality For Context: 90 day 17.3% mortality ELSO* COVID-19 26.9% ECMO Registry 90-Day mortality: 50% * Extracorporeal Life Support Organization Song T, Hayanga J, Durham L, Garrison L, Supady A, Jaros M, Nelson P, Deliargyris EN, Moazami N. ISICEM Br
Slide 39: CTC Registry Conclusions
CTC Registry Conclusions 1) First reported multi-center experience with CytoSorb therapy in COVID-19 patients on ECMO 2) CTC cohort was comparable to the international experience with ECMO in COVID-19 as reported in the ELSO Registry 3) CytoSorb + ECMO ICU Survival at 90 days was 73.1% compared to 5
Slide 40: CytoSorb in COVID-19: ECMO
CytoSorb in COVID-19: ECMO COVID-19 Case Series on ECMO Non COVID-19 ECMO France U.S. Germany Evidence U.S. Rieder Lebreton CTC Registry Geraci* Akil 63 CYTOSORB + ECMO Am J Resp Crit Care J Cardiac Surg Thoracic CV ASAIO J 2021 patients 5 centers 2021 2021 Surgery 2020 11 propective vs 13 propectiv
Slide 41: CytoSorb in COVID-19: CRRT or Hemoperfusion
CytoSorb in COVID-19: CRRT or Hemoperfusion Case Series on Mechanical Ventilation Evidence Saudi- Iran Ecuador Italy Germany Spain Italy Arabia Lopez- Riva Nierhaus Ferrer Rampino 128 CYTOSORB Nassiri Alharthy Almaraz Webinar Webinar Webinar Blood Purif patients Artif Organs Webinar Webinar 10/29/20
Slide 42: U.S. REFRESH 2-AKI Pivotal Trial
U.S. REFRESH 2-AKI Pivotal Trial • The U.S. REFRESH 2-AKI pivotal trial is a 400-patient, 25 center pivotal RCT designed to support U.S. regulatory approval as a prophylactic therapy used during complex open heart surgery such as valve replacement and aortic reconstructive surgery to reduce the seve
Slide 43: Full Approval of STAR-T Trial Begins Priority Path to Potential FDA Marketing Approval
Full Approval of STAR-T Trial Begins Priority Path to Potential FDA Marketing Approval • In April 2020, the FDA granted Breakthrough Designation to CytoSorbents’ technology to remove ticagrelor during cardiopulmonary bypass in emergent or urgent cardiothoracic surgery – a “fast track” for a major un
Slide 44: Co-Principal Investigators of STAR-T
Co-Principal Investigators of STAR-T C. Michael Gibson, MS, MD Michael Mack, MD Interventional Cardiologist Cardiothoracic Surgeon • Professor of Medicine, Harvard Medical School • Chairman, Baylor Scott & White The Heart Hospital • President & CEO of non-profit Baim Institute • President, Baylor Sc
Slide 45: Risk of Bleeding Is High in CABG Patients on Ticagrelor
Risk of Bleeding Is High in CABG Patients on Ticagrelor In the ticagrelor registration PLATO (PLAeleT inhibition and patient Outcomes) trial, 1584 patients underwent CABG surgery, randomized between those who received either ticagrelor or clopidogrel. Those patients (%) with life-threatening bleedin
Slide 46: By Removing Drug, CytoSorb Reduces Bleeding Complications
By Removing Drug, CytoSorb Reduces Bleeding Complications In a separate analysis done in the U.K., this has translated into a projected cost savings to the hospital of approximately $5,000 per patient, including the cost of CytoSorb • Hassan K, et al. Ann Thor Surg. 2019; 1:45-51. • Javanbakht, M, e
Slide 47: United States TAM for Ticagrelor Removal
United States TAM for Ticagrelor Removal 50,000 patients on ticagrelor needing emergent/urgent open heart surgery annually in US X $5,000 per device $250 M Initial U.S. Total Addressable Market Ticagrelor market share expected to grow • CytoSorb makes ticagrelor the only reversible platelet inhibito
Slide 48: Second FDA Breakthrough Designation Awarded to DrugSorb-ATR for DOAC Removal
Second FDA Breakthrough Designation Awarded to DrugSorb-ATR™ for DOAC Removal • In August 2021, the FDA granted a second Breakthrough Designation to DrugSorb-ATR to remove two additional “blood thinners” – the direct oral anticoagulants (DOACs), apixaban (Eliquis®) and rivaroxaban (Xarelto®) during
Slide 49: Addressable U.S. Market For Current and Potential Future Indications for Antithrombotic Removal
Addressable U.S. Market For Current and Potential Future Indications for Antithrombotic Removal by DrugSorb-ATR TICAGRELOR + DOAC All surgery $2.0B TICAGRELOR + DOAC Cardiac surgery $1.0B TICAGRELOR Cardiac surgery $500M (Future) TICAGRELOR Cardiac surgery $250M (Today) 49
Slide 50: Preparing for U.S. Commercialization
Preparing for U.S. Commercialization • U.S. STAR-T and U.S. STAR-D trials are expected to provide both clinical and health economics data to support U.S. launch as well as sales for this application internationally • David Cox, Vice President of Global Regulatory Affairs, is leading the U.S. regulat
Slide 51: Investment Summary
Investment Summary CytoSorbents has the potential to become a highly profitable performer in the therapeutics space with industry-leading operating profit margins • High margin razorblade business model with excellent operating leverage and a solid track record of ex-US growth • Strong foundation an
Slide 52: Investor Relations contact
Investor Relations contact Terri Anne Powers 52 tpowers@cytosorbents.com
Slide 53: CytoSorb in COVID-19 References
CytoSorb in COVID-19 References • Akil, A. et al., Combined Use of CytoSorb and ECMO in Patients with Severe Pneumogenic Sepsis. Thorac Cardiovasc Surg; 2020 Apr 6. Link to pubmed abstract • Alharthy A et al., Continuous renal replacement therapy with the addition of CytoSorb® cartridge in criticall
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