Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (February 2018)
40 slides from Cytosorbents's investor presentation, February 2018
Slide 1: Investor Presentation February 2018
HELPING REDUCE DEADLY UNCONTROLLED INFLAMMATION IN HOSPITALIZED PATIENTS WORLDWIDE NASDAQ: CTSO Investor Presentation February 2018
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 is a Leader in Critical Care Immunotherapy
CytoSorbents is 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 • NASDAQ-traded (CTSO): ~$7.00 per share • CytoSorb®, is E.U. approved, with 35,000+ treatments; distributed in 45 countries • Pre-announced total 2017 revenue of $15M+, including full year CytoSorb sales of $13.2M, with $17.3M in cash at year-end 2017 • ~90 employees with i
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: Uncontrolled Inflammation is Deadly
Uncontrolled Inflammation is Deadly Sepsis Trauma Influenza Burn Injury Millions Die Of Uncontrolled Deadly Inflammation Each Year Lung Injury Cytokine Release Syndrome Pancreatitis Liver Failure Surgical Complications 6
Slide 7: Massive Inflammation Causes Organ Failure
Massive Inflammation Causes Organ Failure Organ failure occurs when vital organs stop working, causing nearly half of all deaths in the ICU. Little can be done to prevent or treat organ failure today 7
Slide 8: No Ideal Options to Treat Severe Inflammation
No Ideal Options to Treat Severe Inflammation 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 ablation Anti-oxidants Anti-leukocyte
Slide 9: CytoSorb Bridges the Gap
CytoSorb Bridges the Gap Anti-Inflammatory Immunosuppressive (too weak) (too strong) NSAIDs Corticosteroids Aspirin Chemotherapy Anti-cytokine Organ transplant antibodies Anti-rejection drugs Anti-integrin Radiation antibodies Immune system Anti-oxidants ablation Anti-leukocyte Abs 9
Slide 10: CytoSorb Reduces the Fuel to the Fire
CytoSorb® Reduces the Fuel to the Fire • CytoSorb® targets the $20+ billion opportunity in critical care and cardiac surgery • Approved in the European Union as the only specifically approved extracorporeal cytokine filter • Broad indication for use where cytokines are elevated • Removes cytokines a
Slide 11: 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 multip
Slide 12: CytoSorb is "Plug and Play"
CytoSorb is “Plug and Play” Compatible with Existing Dialysis and Heart-Lung Machines • Place a temporary dialysis catheter in a major vein • Connect the device to a standard dialysis, ECMO, or heart-lung machine found in hospitals worldwide • Pump blood out of the body and through the cartridge • T
Slide 13: Goal: To Prevent or Treat Organ Failure
Goal: To Prevent or Treat Organ Failure Improve Decrease Patient Costs Of Outcome ICU and and Patient Survival Care Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical The Potential to Revolutionize Critical Care Medicine 13
Slide 14: Refractory Septic Shock
Refractory Septic Shock Prospective, single arm study in 20 patients with refractory late-stage septic shock using CytoSorb aggressively every 12 hours with a new cartridge • Patients had refractory shock despite high doses of vasopressors, respiratory failure requiring mechanical ventilation, oligo
Slide 15: Vasoplegia and Heart Transplantation
Vasoplegia and Heart Transplantation Prospective, single arm observational study, where propensity score matching of a total of 84 heart transplant patients (60 control, 24 treatment using CytoSorb during surgery) yielded a total of 16 matched pairs of control and treatment patients • Post-operative
Slide 16: Seasonal Influenza
Seasonal Influenza • Seasonal influenza in the US (CDC data) • Current 2017-18 US epidemic is particularly severe • Poor vaccine coverage, virulent H3N2 strain, widespread • In addition to very young and elderly, otherwise healthy people are dying from influenza • Cytokine storm, severe inflammation
Slide 17: Case Report: Influenza
Case Report: Influenza 56 year old man with documented swine (H1N1) influenza with multiple organ failure. Interferon levels were undetectable Treatment day 1 2 3 4 5 6 7 IL-6 (before) 8,076 1,025 527 172 117 120 107 pg/mL IL-6 (after) pg/mL 2,621 663 289 76 110 111 94 IL-6 (% change) -68% -35% -45%
Slide 18: CAR-T Cell Immunotherapy and CRS
CAR-T Cell Immunotherapy and CRS • CAR-T cell cancer immunotherapy is a blood cancer treatment breakthrough. • However, ~40-50% of patients can develop severe, high grade cytokine release syndrome (CRS), a cytokine storm that can lead to rapid organ failure and potentially death • CytoSorb® was spec
Slide 19: The World Needs CytoSorb
The World Needs Cyto Cyto Tor Sepals Appear to Be Rising Dramatically ‘as a Global Health Priority — ap = ‘America Hasa $27 — a 19
Slide 20: Blood Purification Alternatives
Blood Purification Alternatives Blood Compatible Blood Incompatible HMCO Sorbents Sorbents Filters EMiC2 - Fresenius CytoSorb CPFA - Bellco CytoSorbents I.M.P.A.C.T - Hemolife SepteX - Baxter Oxiris - Baxter Theranova - Baxter
Slide 21: CytoSorb
CytoSorb 35,000+ Treatments 45 Countries Worldwide with E.U. United States Critical Care Cardiac Surgery Cardiac Surgery I REFRESH 2 Start Q1 2018 60+ Investigator Initiated Studies 2020 21
Slide 22: CytoSorb Is Like a High Margin Razorblade
CytoSorb® Is Like a High Margin Razorblade • High margin “razorblade” fully compatible with existing installed base of “razor” blood pumps: Dialysis/CRRT, ECMO machines (ICU), heart-lung machines (OR) • Blended gross margins are nearly 70%, expected to rise with new plant (1H 2018) • Average Direct
Slide 23: Direct Sales: Focused on 5 Countries
Direct Sales: Focused on 5 Countries CytoSorbents’ direct sales force focused on most major university and public hospitals in Germany, Austria, Switzerland, Belgium and Dr. Christian Steiner, MD Luxembourg. German market alone is $1.0-1.5 billion Vice President – Sales and Marketing and General Man
Slide 24: Dedicated Reimbursement In Germany
Dedicated Reimbursement In Germany • CytoSorb achieved a permanent, dedicated reimbursement code in Germany • Most important market and the largest medical device market in Europe and third largest in the world • Was achieved rapidly through the initiative and strong support of several major medical
Slide 25: CytoSorb Distributed in 45 Countries
CytoSorb® Distributed in 45 Countries IntensivMed WMC 25
Slide 26: Four Major Partnerships, Potential for More
Four Major Partnerships, Potential for More Critical Care or Catheters Cardiac Surgery Renal Dialysis Blood Transfusion Pharma and Biotech Partnered with leading multinational corporations: Fresenius Medical Care, Terumo Cardiovascular, Biocon Ltd, and Dr. Reddy’s Laboratories * Companies listed her
Slide 27: Expanded Fresenius Partnership
Expanded Fresenius Partnership • CytoSorbents renewed and expanded its partnership with Fresenius Medical Care in January 2017 • Extension on exclusive distribution of CytoSorb for critical care applications in France, Poland, Denmark, Norway, Sweden, and Finland through 2019 • Guaranteed minimum qu
Slide 28: Launched in December
Launched in December • Entered into a multi-country strategic partnership with Terumo Cardiovascular Group, a global leader in medical devices for cardiac and vascular surgery • Initial exclusive distribution of CytoSorb® CPB Procedure Pack for intra-operative use during cardiac surgery in France, D
Slide 29: U.S. Approval Targets Cardiac Surgery
U.S. Approval Targets Cardiac Surgery • Heart disease is the leading cause of death worldwide driven by smoking, unhealthy lifestyles, and an aging population • ~1M cardiac surgeries performed annually in U.S. and E.U. • Coronary artery bypass graft surgery • Valve repair or replacement • Heart or l
Slide 30: U.S. REFRESH Trial
U.S. REFRESH 1 Trial REduction in FREe Hemoglobin • 46-patient, eight-center trial evaluating the safety and efficacy of intra-operative use of CytoSorb® in a heart-lung machine during elective, non-emergent complex cardiac surgery with heart-lung machine time ≥ 3 hours • Working with major cardiac
Slide 31: REFRESH 2 - AKI Targets US Approval
REFRESH 2 - AKI Targets US Approval REFRESH 2 – AKI is a pivotal, multi-center RCT using CytoSorb intraoperatively to reduce the incidence or severity of acute kidney injury (AKI) in high risk cardiac surgery patients • The development of even mild AKI after surgery predicts 1 and 5 year mortality a
Slide 32: German Govt Funding REMOVE Endocarditis Trial
German Govt Funding REMOVE Endocarditis Trial • 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 due to the opiate crisis • Patients often require open hea
Slide 33: Q4 2017 and Year End Guidance
Q4 2017 and Year End Guidance The Company expects to announce record results including: • Full year 2017 total revenue in excess of $15 million and Q4 2017 total revenue of approximately $4.6 million (range $4.5 - 4.7M) • Full year 2017 CytoSorb sales of approximately $13.2 million (range $13.1 - 13
Slide 34: Quarterly Product Sales
Quarterly Product Sales $4,500,000 $4,200,000 CytoSorb® Product Sales $4,000,000 $3,448,661 $3,500,000 $3,041,012 $3,000,000 $2,596,133 $2,612,801 $2,500,000 $2,143,116 $1,852,670 $2,000,000 $1,597,449 $1,495,590 $1,500,000 $1,031,761 $1,071,459 $871,150 $773,112 $1,000,000 $663,233 $703,658 $569,24
Slide 35: Historical Annual Product Sales
Historical Annual Product Sales Over the past three years, the compound growth rate of return (“CAGR”) on product sales was 62% $14,000,000 $13,200,000 CytoSorb® Product Sales $12,000,000 $10,000,000 $8,206,036 $8,000,000 Trend Line $6,000,000 $4,043,819 $4,000,000 $3,135,387 $2,000,000 $821,787 $-
Slide 36: 2018: Rapid Growth & Operating Profitability
2018: Rapid Growth & Operating Profitability Targeting rapid growth and the achievement of operating profitability* on a quarterly basis later this year • CytoSorb is a high clinical impact “need to have” device that saves lives which justifies usage, strong average selling prices, and reimbursement
Slide 37: Gaining Broader Industry Accolades
Gaining Broader Industry Accolades • Winner of 2017 Global Frost & Sullivan Product Leadership Award in Blood Purification “There were many factors that led to our selection of CytoSorb® for this year’s Global Product Leadership Award,” said Frost & Sullivan Research Analyst Aish Vivek. “Among the m
Slide 38: Upcoming Milestones
Upcoming Milestones • Ongoing progress in international sales • Operating profitability targeted in 2018 • Potential new partnerships and expansion of existing partnerships • Near-term initiation of pivotal REFRESH 2 study • Publications of clinical and research data • Greater investor awareness thr
Slide 39: CytoSorbents Investment Summary
CytoSorbents Investment Summary CytoSorbents is strongly positioned and on track to have strong growth in 2018 • Established, well-run U.S. medtech but with a biotech profile, nearing critical mass • Strategically positioned and addressing some of the largest, most visible, unmet medical needs world
Slide 40: Contact
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com