Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Investor Presentation (October 2017)
37 slides from Cytosorbents's investor presentation, October 2017
Slide 1: Investor Presentation October 2017
HELPING REDUCE DEADLY UNCONTROLLED INFLAMMATION IN HOSPITALIZED PATIENTS WORLDWIDE NASDAQ: CTSO Investor Presentation October 2017
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): ~$6.00 per share • CytoSorb®, is E.U. approved, with 27,000+ treatments; distributed in 44 countries • Trailing 12-month sales of $10.4M vs $6.0M a year ago, blended gross margins = 65% • 80 employees with international footprint across two wholly-own
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: Anti-Inflammatory vs Immunosuppressive
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 Removes the Fuel to the Fire
CytoSorb® Removes 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 . • Protected by 32 issued US patents and multi
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: Case Report: Toxic Shock Syndrome
Case Report: Toxic Shock Syndrome • 17 year old man suffered an injury to his ankle and unexpectedly began to develop fever • He rapidly deteriorated and was hospitalized the next day at a major hospital in Rotterdam, Netherlands where antibiotics were started immediately. He continued to decline an
Slide 15: The World Needs CytoSorb
The World Needs Cyto Len >= a) ‘1 AmericaHasa$278 15
Slide 16: Blood Purification Alternatives
Blood Purification Alternatives Coupled Plasma Therapeutic Sorbents HMCO Filters Filtration Adsorption Plasma Exchange EMiC2 - Fresenius CPFA - Bellco I.M.P.A.C.T - Hemolife CytoSorb – CytoSorbents SepteX – Baxter/Gambro Theranova - Baxter
Slide 17: CytoSorb
CytoSorb 27,000+ Treatments 44 Countries Worldwide with E.U. United States Critical Care Cardiac Surgery Cardiac Surgery 21,000+ 6,000+ I REFRESH 2 Start 2H 2017 $10.4M Sales 60+ Investigator Initiated Studies. More than two dozen peer reviewed publications in the 2020 past 12 months 17
Slide 18: CytoSorb Is Like a High Margin Razorblade
CytoSorb® Is Like a High Margin Razorblade • CytoSorbents is a pure play high margin disposables business where the CytoSorb “razorblade” is fully compatible with the existing installed base of “razor” ICU dialysis and ECMO machines, and heart-lung machines in the operating room • Blended gross marg
Slide 19: Direct Sales: Expanded to 5 Countries
Direct Sales: Expanded to 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 Ma
Slide 20: Dedicated Reimbursement In Germany
Dedicated Reimbursement In Germany • CytoSorb has achieved a permanent, dedicated reimbursement code in Germany – our most important market and the largest medical device market in Europe • We believe this has the potential to validate the importance of our therapy to physicians in the country • Was
Slide 21: CytoSorb Distributed in 44 Countries
CytoSorb® Distributed in 44 Countries IntensivMed WMC 21
Slide 22: 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 23: 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 24: Terumo Partnership 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 25: Launch of New Therapeutic-ECMO Kit
Launch of New Therapeutic-ECMO Kit • Respiratory failure is often caused by excessive inflammation causing capillary leak syndrome in the lungs – “drowning from inside out” • Mechanical ventilation for respiratory failure is dangerous: oxygen toxicity, pressure and volume trauma on lungs, complicati
Slide 26: CAR-T Cell Immunotherapy and CRS
CAR-T Cell Immunotherapy and CRS • CAR-T cell cancer immunotherapy is one of the most promising treatments for blood cancers. However, ~40-50% of patients develop cytokine release syndrome (CRS), a cytokine storm that can lead to rapid organ failure and potentially death • CytoSorb® was specifically
Slide 27: Solid Organ Rehabilitation for Transplant
Solid Organ Rehabilitation for Transplant • ~120,000 solid organs were transplanted in 2014, < 10% of the global need • Transplanted kidneys accounted for two-thirds of all transplants but 20% of donated kidneys are discarded because they do not meet organ donor criteria • Other solid organs, partic
Slide 28: 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 29: U.S. REFRESH 1 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 30: U.S. REFRESH 2 Pivotal Trial
U.S. REFRESH 2 Pivotal Trial • Plan to meet with the FDA shortly to confirm the clinical trial strategy and trial design for REFRESH 2 cardiac surgery, with goal to start trial 2H 2017 • REFRESH 2 is expected to be similar in design to REFRESH 1, but enriched with patients undergoing valve replaceme
Slide 31: Quarterly Product Sales
Quarterly Product Sales CytoSorb® Product Sales $3,041,012 $3,000,000 CytoSorb® Product Sales $2,612,801 $2,596,133 $2,500,000 $2,143,116 $2,000,000 $1,852,670 $1,597,449 $1,495,590 $1,500,000 $1,031,761 $1,071,459 $1,000,000 $871,150 $773,112 $663,233 $703,658 $569,243 $500,000 $314,159 $176,098 $2
Slide 32: Trailing Twelve Months Product Sales
Trailing Twelve Months Product Sales Over the past three years, the compound growth rate of return (“CAGR”) on product sales was 81% $12,000,000 Trailing Twelve Month Product Sales $10,393,062 $10,000,000 $8,000,000 Trend Line $6,017,168 $6,000,000 $4,000,000 $3,379,681 $2,000,000 $1,750,196 $405,70
Slide 33: Driving Toward Operating Breakeven
Driving Toward Operating Breakeven Trailing Twelve Months Key Performance Indicators $12.0 $10.0 Product Revenue $8.0 Gross Margin ($M) $6.0 Fixed Operating Expenses $4.0 (Excluding non-cash, clinical and certain variable expenses.) $2.0 $0.0 Q2 2014 Q2 2015 Q2 2016 Q2 2017 33
Slide 34: The Company is Well-Capitalized
The Company is Well-Capitalized Working Capital as of 6/30/17 3/31/17 12/31/16 12/31/15 12/31/14 Current Assets: Cash and short-term investments $ 16,402 $ 3,240 $ 5,245 $ 7,509 $ 5,550 Grants and accounts receivable, net 2,059 1,732 1,433 649 819 Inventories 890 858 834 1,191 538 Prepaid expenses a
Slide 35: Upcoming Milestones
Upcoming Milestones • Ongoing progress in international sales • Operating profitability targeted in 2018 • Potential new partnerships and expansion of existing partnerships • FDA filing for cardiac surgery trial • Q4 2017 initiation of pivotal REFRESH 2 study • Publications of clinical and research
Slide 36: CytoSorbents Investment Summary
CytoSorbents Investment Summary CytoSorbents is strongly positioned and on track to have our strongest year ever • 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 wor
Slide 37: Contact: Dr. Phillip Chan, CEO
NASDAQ: CTSO Dr. Phillip Chan, MD, PhD – CEO pchan@cytosorbents.com