CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Q2 2015 Earnings Presentation
32 slides from CytoSorbents's earnings presentation, Aug 13, 2015
Slide 1: CytoSorbents Corporation Q2 2015 Earnings Conference Call
CytoSorbents Corporation (NASDAQ: CTSO) A Leader in Critical Care Immunotherapy Q2 2015 Earnings Conference Call August 13, 2015
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiaries CytoSorbents Medical, Inc and CytoSorbents Europe GmbH that are not historical facts are forward-looking statements and are subject to risks and uncertainties that could cause actu
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: Case Report Video
Case Report Video Please note: Because of different internet speeds of participants on today’s call, there may be a slight waiting period after the video plays on your computer as others finish watching the video. We will promptly get back to the slide presentation 4
Slide 5: 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 cytokine filter • Clinically proven to remove key cytokines in the blood of critically-ill patients • Approve
Slide 6: 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 6
Slide 7: Operating and Financial Highlights
Operating and Financial Highlights 7
Slide 8: Q2 2015 Comparative Revenue Results
Q2 2015 Comparative Revenue Results Three Months Three Months Ended June 30, Ended June 30, 2015 2014 % Incr. Product revenue $ 773,112 $ 663,233 17% Grant and other income 190,827 361,422 (47)% Total revenue $ 963,939 $ 1,024,655 (6)% • CytoSorb® product sales were $773K in Q2 2015, a 17% increase
Slide 9: 6 Months Comparative Revenue Results
6 Months Comparative Revenue Results Six Months Six Months Ended June 30, Ended June 30, 2015 2014 % Incr. Product revenue $ 1,476,770 $ 1,232,476 20% Grant and other income 210,243 854,351 (75)% Total revenue $ 1,687,013 $ 2,086,827 (19)% • CytoSorb® product sales were $1.5M for the six months ende
Slide 10: Quarterly Product Sales
Quarterly Product Sales $1,200,000 CytoSorb® Product Sales $1,031,761 $1,000,000 $871,150 $773,112 $800,000 $703,658 $663,233 $600,000 $569,243 $400,000 $314,159 $176,098 $203,561 $200,000 $127,969 $87,960 $13,679 $0 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 2012 2012 2013 2013 2013 2013 2014 2014 2014 20
Slide 11: Quarterly Euro-Adjusted Product Sales
Quarterly “Euro-Adjusted” Product Sales $1,200,000 CytoSorb® "Euro Adjusted" Product Sales $1,031,761 $1,000,000 $920,041 $871,150 $816,109 $800,000 $663,233 $600,000 $569,243 $400,000 $314,159 $203,561 $200,000 $176,098 $127,969 $87,960 $13,679 $0 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1
Slide 12: Working Capital and Cap Table
Working Capital and Cap Table Working Capital as of 6/30/15 3/31/15 12/31/14 12/31/13 12/31/12 Current Assets: Cash and short-term investments $ 11,205 $ 13,358 $ 5,550 $ 2,183 $ 1,729 Grants and accounts receivable, net 501 673 819 453 51 Inventories 1,060 703 538 245 682 Prepaid expenses and other
Slide 13: Added to the Russell Microcap Index
Added to the Russell Microcap Index June 2015 13
Slide 14: Second Half 2015 Catalysts
Second Half 2015 Catalysts 14
Slide 15: Strengthening the Direct Sales Team
Strengthening the Direct Sales Team Contract Sales Rep 8: Sales Rep 9: Sales Rep Currently Currently Cardiac Surgery Screening Screening Medical Science Liaison 15
Slide 16: Starting Sales Now in 3 New Countries
Starting Sales Now in 3 New Countries Saudi approval with Medical Device Marketing Authorization • Enables sales in Saudi Arabia (29M people) via our partner, Techno Orbits • Tender orders can be substantial • Potentially opens doors to rest of Middle East Signed with TekMed for Australia and New Ze
Slide 17: Fresenius Medical Care in 2H 2015
Fresenius Medical Care in 2H 2015 • Initial marketing to key opinion leaders in critical care is planned in Q3 2015 in France, Sweden, Norway, Finland, Denmark and Poland (131M people) • CytoSorb will not only be certified on the existing Fresenius multiFiltrate, but will also be certified on the ne
Slide 18: Sowing the Seeds of Growth
Sowing the Seeds of Growth Q3 2015 Start 131M people Estimated 2016 Start Q3 2015 Start 57M people We are just tapping into these major markets. We expect Q3 2015 to begin to reflect initiation of selling in new markets covering 188 million people ≈ 600,000 cases of severe sepsis/shock per year. Giv
Slide 19: Growth Driven by Direct, Distributor, Partner Sales
Growth Driven by Direct, Distributor, Partner Sales * This graph is provided only to demonstrate the concept of revenue layering. It does NOT represent revenue forecasts or guidance 19
Slide 20: Cardiac Surgery Partner Update
Cardiac Surgery Partner Update • The evaluation by our cardiac surgery partner in France, one of the top-4 cardiac surgery companies in the world, continues to go well and, though slower than anticipated, should be completed in the next several months • Meanwhile, two randomized, controlled studies
Slide 21: REFRESH Update
REFRESH Update REduction in FREe Hemoglobin • FDA approved our amendment to expand the trial to a 40-patient randomized controlled study at 8 centers • Led by our Chief Medical Officer, Dr. Robert Bartlett, we are in the process of negotiating and finalizing clinical trial agreements and obtaining I
Slide 22: REFRESH Trial Overview
REFRESH Trial Overview • 40 patient, 8-center randomized controlled feasibility study using CytoSorb intra-operatively in a bypass circuit during complex cardiac surgery lasting more than 180 minutes • Standard of care (20 control) vs CytoSorb + Standard of care (20 treatment) • Primary safety endpo
Slide 23: Dangers of Plasma Free Hemoglobin (PfHb)
Dangers of Plasma Free Hemoglobin (PfHb) Patients undergoing complex cardiac surgery with significant cardiotomy suction are at highest risk of hemolysis, releasing large amounts of PfHb into circulation Once the haptoglobin scavenging system is overwhelmed, PfHb can cause a direct depletion of plas
Slide 24: Leading Advisors in Cardiac Surgery
Leading Advisors in Cardiac Surgery Dr. Joe Zwischenberger, M.D. Dr. Paul Checchia, M.D. - SAB Chair Dr. Robert Bartlett, M.D. Texas Children’s Dr. Jonathan William Haft, M.D. University of Kentucky University of Michigan Hospital in Houston University of Michigan Dr. Nicholas Smedira, M.D. Dr. Crai
Slide 25: FDA Expedited Access Pathway (EAP)
FDA Expedited Access Pathway (EAP) The FDA has issued formal guidance on the EAP program that will facilitate the approval of medical devices that treat life-threatening conditions and have no approved alternative treatments • We believe that CytoSorb® is an excellent candidate for EAP Designation (
Slide 26: CytoSorb Attacks Sepsis Broadly
CytoSorb Attacks Sepsis Broadly Inflammatory cytokines (organ failure) & other factors Immunosuppressive cytokines & re-establish immune responsiveness Many bacterial toxins (organ failure) Re-establish proper leukocyte trafficking to prevent cell-mediated organ injury MAP Improvement in hemodynamic
Slide 27: CytoSorb SIRS and Sepsis: Regain Control!
CytoSorb® SIRS and Sepsis: Regain Control! 27
Slide 28: Case Report: Septic Shock
Case Report: Septic Shock • 72 year old male patient was admitted with sepsis from a urinary tract infection • His condition and hemodynamic stability rapidly deteriorated with concurrent elevation in plasma inflammatory markers, despite broad antibiotic coverage • Developed full-blown multi-organ f
Slide 29: Case Report: ARDS & Multi-organ Failure
Case Report: ARDS & Multi-organ Failure • A 45-year-old male patient was admitted with small intestine obstruction due to torsion • Immediately scheduled for surgical intervention, but aspirated at anesthesia induction • Rapidly developed one of the worst and most fatal forms of lung failure called
Slide 30: Case Report: Rhabdomyolysis
Case Report: Rhabdomyolysis • A 55 year old patient was transferred from an outside hospital with sepsis from pneumonia and ARDS due to complications • He had developed a complication called “compartment syndrome” where high pressure builds up in a muscle compartment that cannot expand. The muscle t
Slide 31: Much More to Report
Much More to Report CytoSorb® is helping to save lives around the world. More clinical data will be made public in October at three major upcoming events. European Society of Intensive Care Medicine Berlin, Germany October 2, 2015 31
Slide 32: Q&A Session
Q&A Session CytoSorbents Corporation NASDAQ: CTSO Phillip P. Chan, MD, PhD - CEO 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 pchan@cytosorbents.com A Leader in Critical Care Immunotherapy Company 32