Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Q1 2021 Earnings Presentation
44 slides from Cytosorbents's earnings presentation, May 4, 2021
Slide 1: Investor Presentation April 2021
HELPING REDUCE DEADLY UNCONTROLLED INFLAMMATION IN HOSPITALIZED PATIENTS WORLDWIDE NASDAQ: CTSO Investor Presentation April 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 in the ICU and Cardiac Surgery using CytoSorb® Blood Purification 3
Slide 4: CytoSorbents At a Glance
CytoSorbents At a Glance (NASDAQ: CTSO) • CytoSorbents is a rapidly growing international NASDAQ-traded medical device company with ~200 employees, $39.5M in 2020 product sales & $71M in cash (2020) • CytoSorb® is E.U. approved and commercialized in 67 countries as an extracorporeal cytokine adsorbe
Slide 5: Products and Product Pipeline
Products and Product Pipeline Internal development supplemented by strong government support with ~$38M in grants, contracts, other non-dilutive funds awarded to our technology from DARPA, NIH, NHLBI, US Army, US Air Force, HHS, and others, to date Sepsis, Critical Care, HemoDefend RBC Purifcation o
Slide 6: What does CytoSorb do and How does it work?
What does CytoSorb do and How does it work?? 6
Slide 7: Millions Die from Uncontrolled Deadly Inflammation
Millions Die from Uncontrolled Deadly Inflammation Sepsis Trauma Influenza Burn Injury Difficult to control and often leads to the failure of vital organs and death Lung Injury Cytokine Release Syndrome COVID-19 Liver Failure Surgical Complications 7
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 121,000 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 16 issue
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 and Financial performance?
What is the Company’s Business model and Financial performance? 11
Slide 12: CytoSorbents Has a Strong Hybrid Sales Model
CytoSorbents Has a Strong Hybrid Sales Model 67 Countries Worldwide and 121,000+ treatments Critical Care and Cardiac Surgery Direct Sales Distributor and Partner Sales Direct sales in 10 countries: Distributor and Partner sales in 57 other countries Germany, Austria, Switzerland, Belgium, Entered U
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 ~80% in Q4 2020, driven by volume production from our new manufac
Slide 15: Quarterly Product Sales
$10,000,000 $0 $12,000,000 $2,000,000 $8,000,000 $4,000,000 $6,000,000 Q1 2015 $703,658 Q2 2015 $773,112 Q3 2015 $1,071,459 Q4 2015 $1,495,590 Q1 2016 $1,597,449 Q2 2016 $1,852,670 Q3 2016 $2,143,116 Q4 2016 $2,612,801 Q1 2017 $2,596,133 Quarterly Product Sales Q2 2017 $3,041,012 15 Q3 2017 $3,448,6
Slide 16: Annual Product Sales and Gross Margins
Annual Product Sales and Gross Margins 2020 Product Sales grew 73% over 2019, with Q4 2020 Gross Margins of 82% $40,000,000 $39,452,502 85% $35,000,000 80% $30,000,000 $25,000,000 $22,765,854 75% $20,252,383 $20,000,000 $15,000,000 $13,381,853 70% $10,000,000 $8,206,036 65% $5,000,000 $3,135,387 $4,
Slide 17: What are the catalysts for growth?
What are the catalysts for growth? 17
Slide 18: 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 18
Slide 19: 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 >5,000 critic
Slide 20: 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 • Based on projected growth, we are evaluating relocation options to increase manufacturing capacity by 5x to $3
Slide 21: Expanded Workforce from 105 to 200 in 2+ Years
Expanded Workforce from 105 to 200 in 2+ Years Increased headcount focused heavily on commercialization and manufacturing to drive growth February 2021 November 2018 21
Slide 22: 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 23: Catalyzing CytoSorb Sales in Germany
Catalyzing CytoSorb Sales in Germany • In 2020, Germany accounts 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 t
Slide 24: 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 25: 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 26: 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 27: 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 28: 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 29: 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 30: 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 31: Global COVID-19 CytoSorb Activity
Global COVID-19 CytoSorb Activity CytoSorb has been used in ~5,000 COVID-19 Patients in 30+ countries. As an E.U. approved extracorporeal cytokine adsorber, more than 121,000 treatments have been delivered to date CAN – Medical Device Authorization 31
Slide 32: CytoSorb in COVID-19: CRRT or Hemoperfusion
CytoSorb in COVID-19: CRRT or Hemoperfusion Case Series on Mechanical Ventilation Evidence Saudi- Ecuador Iran Italy Germany Spain Italy Arabia Lopez- 128 CYTOSORB Nassiri Riva Nierhaus Ferrer Rampino Alharthy Almaraz patients Webinar Webinar Webinar Webinar Blood Purif Artif Organs Webinar 10/29/20
Slide 33: CytoSorb in COVID-19: ECMO
CytoSorb in COVID-19: ECMO COVID-19 Case Series on ECMO Non COVID-19 ECMO France Germany Evidence Germany U.S. U.S. Akil Rieder Rieder Lebreton Durham Moazami 57 CYTOSORB + ECMO Am J Resp Crit Thoracic CV ASAIO J 2021 patients Crit Care 2020 Pers. Comm Webinar 6.25.20 Care 2021 Surgery 2020 11 prope
Slide 34: Unlocking the U.S. Opportunity
Unlocking the U.S. Opportunity REFRESH 2-AKI Pivotal Trial 34
Slide 35: 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 36: FDA Breakthrough Designation Sets Stage for Expedited U.S. Regulatory Path
FDA Breakthrough Designation Sets Stage for Potential Expedited U.S. Regulatory Path • In April 2020, the FDA granted Breakthrough Designation to CytoSorb to remove ticagrelor during cardiopulmonary bypass in emergent or urgent cardiothoracic surgery – a “fast track” for a major unmet medical need •
Slide 37: 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 38: 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 39: 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 40: Addressable U.S. Market for Antithrombotic Removal by CytoSorb
Addressable U.S. Market For Current and Potential Future Indications for Antithrombotic Removal by CytoSorb TICAGRELOR + NOAC All surgery $1.5B TICAGRELOR + NOAC Cardiac surgery $500M TICAGRELOR Cardiac surgery $250M (Additional future) TICAGRELOR Cardiac surgery $250M (Today) 40
Slide 41: Preparing for U.S. Commercialization
Preparing for U.S. Commercialization • U.S. STAR-T trial is expected to provide both clinical and health economics data to support U.S. launch as well as sales for this application internationally • Recently hired James Komsa as Vice President of US Sales and Marketing to initially manage U.S. COVID
Slide 42: Investment Summary
Investment Summary CytoSorbents has the potential to become a highly profitable elite 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 foundat
Slide 43: Dr. Phillip Chan, MD, PhD – CEO
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com
Slide 44: 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