CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Q3 2015 Earnings Presentation
34 slides from CytoSorbents's earnings presentation, Nov 13, 2015
Slide 1: CytoSorbents Corporation Q3 2015 Earnings Conference Call
CytoSorbents Corporation (NASDAQ: CTSO) A Leader in Critical Care Immunotherapy Q3 2015 Earnings Conference Call November 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: Severe Inflammation is Deadly in the ICU
Severe Inflammation is Deadly in the ICU Millions of people are admitted to the intensive care unit in hospitals worldwide each year with deadly inflammatory conditions Cancer Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Immunotherapy • In these conditions, massive inflammation driven by a
Slide 5: Severe Inflammation is Dangerous in Open Heart Surgery
Severe Inflammation is Dangerous in Open Heart Surgery ~1 million Open Heart Surgeries in US and EU annually • Coronary artery bypass graft surgery • Valve repair or replacement • Heart or lung transplantation • Congenital defect repair • Aortic reconstruction In complex cardiac surgeries, patients
Slide 6: 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 • Clinically proven to remove key cytokines in the blood of critically-ill pa
Slide 7: 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 7
Slide 8: Evolution of the CytoSorb Market
Evolution of the CytoSorb Market Total Addressable Start Here Drive Standard of Care in A, B, and C Market Advanced disease. Difficult and expensive to treat, very high risk of death, Most compelling $1-5 B A risk/reward for CytoSorb at any phase, early or late Patients are very sick, many will get
Slide 9: Financial Highlights
Financial Highlights med CVtOSorbents forking to Save Lives Through Blood Purification
Slide 10: Q3 2015 Comparative Revenue Results
Q3 2015 Comparative Revenue Results Three Months Three Months Ended Sept 30, Ended Sept 30, 2015 2014 % Incr. Product revenue $ 1,071,459 $ 1,031,761 4% Grant and other income 272,166 130,586 108% Total revenue $1,343,625 $ 1,162,347 16% • CytoSorb® product sales were approximately $1.1M in Q3 2015,
Slide 11: 9 Months Comparative Revenue Results
9 Months Comparative Revenue Results Nine Months Nine Months Ended Sept 30, Ended Sept 30, 2015 2014 % Incr. Product revenue $ 2,548,229 $ 2,264,237 13% Grant and other income 482,393 984,937 (51)% Total revenue $ 3,030,622 $ 3,249,174 (7)% • CytoSorb® product sales were $2.5M for the nine months en
Slide 12: Quarterly Euro-Adjusted Product Sales
Quarterly “Euro-Adjusted” Product Sales $1,400,000 CytoSorb® "Euro Adjusted" Product Sales $1,221,694 $1,200,000 $1,031,761 $1,000,000 $920,041 $871,150 $816,109 $800,000 $663,233 $569,243 $600,000 $400,000 $314,159 $176,098 $203,561 $200,000 $127,969 $87,960 $13,679 $0 Q3 2012 Q4 2012 Q1 2013 Q2 20
Slide 13: Product Sales Growth, Euro Adjusted
Product Sales Growth, “Euro Adjusted” $4,500,000 Trailing Twelve Month Product Sales $4,000,000 $3,828,994 $3,639,061 $3,500,000 Impact of Euro $3,382,253 $3,135,387 Reported Sales $3,000,000 $2,578,396 $2,500,000 $2,000,000 $1,750,196 $1,500,000 $1,214,932 $1,000,000 $821,787 $595,588 $500,000 $310
Slide 14: Working Capital and Cap Table
Working Capital and Cap Table Working Capital as of 9/30/2015 6/30/15 3/31/15 12/31/14 12/31/13 Current Assets: Cash and short-term investments $ 9,329 $ 11,205 $ 13,358 $ 5,550 $ 2,183 Grants and accounts receivable, net 553 501 673 819 453 Inventories 1,337 1,060 703 538 245 Prepaid expenses and o
Slide 15: Operating Highlights
Operating Highlights med CVtOSorbents forking to Save Lives Through Blood Purification
Slide 16: Submitted for Expedited Access Pathway
Submitted for Expedited Access Pathway The FDA has established the Expedited Access Pathway (EAP) program that is intended to facilitate the approval of medical devices that treat life-threatening conditions and have no approved alternative treatments • We have submitted our EAP Application to reque
Slide 17: 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, is now successfully completed. We are currently in discussions with the cardiac surgery partner and will have an update at the appropriate time • CytoSor
Slide 18: Cardiac Surgery IIT Updates
Cardiac Surgery IIT Updates At the 2nd International CytoSorb Users Meeting, preliminary results were presented from three safety and inflammatory mediator biomarker studies using CytoSorb® intra- operatively in a heart-lung machine in low risk cardiac surgery patients: •University of Hamburg-Eppend
Slide 19: REFRESH Update
REFRESH Update REduction in FREe Hemoglobin Trial • 40-patient RCT safety and feasibility study using CytoSorb intra-operatively in a heart-lung machine bypass circuit on patients undergoing complex cardiac surgery • Endpoints include safety and free hemoglobin removal from blood • Working with majo
Slide 20: Fresenius Medical Care by Q1 2016
Fresenius Medical Care by Q1 2016 • We are currently working with Fresenius in the initial marketing to critical care key opinion leaders in multiple countries • CytoSorb will not only be certified on the existing Fresenius multiFiltrate, but will also be certified on the newly launched multiFiltrat
Slide 21: Beads Enable a Broad and Valuable Pipeline
Beads Enable a Broad and Valuable Pipeline ContrastSorb DrugSorb BetaSorb Critical Care, High Blood CT Imaging, Drug Overdose, Improving Risk Surgery Collection & Interventional Chemo Removal Dialysis Transfusion Radiology CE Mark Approved Under Development 21
Slide 22: Blood Transfusion Carries Risks
Blood Transfusion Carries Risks • 85M pRBCs transfused WW each year with 15M in the US alone • While blood transfusion is considered safe, in the US alone there were over 65,000 transfusion reactions as per the National Blood Collection and Utilization Survey Report • Exact cause is unknown, but lin
Slide 23: The HemoDefend Solution
The HemoDefend Solution ™ HemoDefend is a small, in-line, point-of-transfusion filter ™ • Contains hemocompatible, porous polymer beads that can improve the quality and safety of blood by broadly reducing contaminants in packed red blood cells (pRBCs) that can cause transfusion reactions • Designed
Slide 24: HemoDefend Washes Blood Without Washing
HemoDefend “Washes Blood” Without Washing ™ HemoDefend™ aims to improve blood quality and reduce transfusion reactions by effectively “washing blood” but without the time, expense and equipment required to do so The in-line filter targets the removal of broad range of blood contaminants including: %
Slide 25: Government Validation of HemoDefend Technology
Government Validation of HemoDefend Technology Awarded $1.7M in a Phase I and II SBIR Contract by National Heart, Lung, and Blood Institute (NHLBI), a division of NIH Overall goal is to reduce contaminants in packed red blood cells that can that can cause transfusion reactions Key Collaborator • Dr.
Slide 26: CytoSorb SIRS and Sepsis: Regain Control!
CytoSorb® SIRS and Sepsis: Regain Control! 26
Slide 27: CytoSorbents KOL Video
CytoSorbents KOL 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 27
Slide 28: Case Report: Toxic Shock Syndrome
Case Report: Toxic Shock Syndrome • A 4-year, 38 pound girl was stung by an insect on her right leg which became infected • She was admitted to Medical Center of University of Debrecen, Hungary, (Fresenius Medical Center Hungary affiliated with the university) in August 2015 • She was diagnosed with
Slide 29: Case Report: Toxic Shock Syndrome
Case Report: Toxic Shock Syndrome • Despite antibiotics, her condition rapidly worsened and developed a systemic inflammatory response syndrome with the onset of multiple organ failure • Required mechanical ventilation for acute respiratory distress syndrome, vasopressors for shock, and acute kidney
Slide 30: Case Report: Toxic Shock Syndrome
Case Report: Toxic Shock Syndrome • She was stabilized with 72 hours with CytoSorb accompanied with CVVHD (continuous hemodialysis) using regional citrate anticoagulation (CiCa), and then continued on CVVHD for 5 days afterwards • She made a complete recovery after 3 weeks. CytoSorb was credited wit
Slide 31: Case Report: CytoSorb and Liver Support
Case Report: CytoSorb and Liver Support • A 36 year-old male patient with ulcerative colitis treated with prednisolone and azathioprine developed Pneumocystis and Cytomegalovirus opportunistic infections • Patient developed severe multiple organ failure with septic shock, severe acute respiratory di
Slide 32: Case Report: Pyelonephritis
Case Report: Pyelonephritis • 56 year old patient was admitted and diagnosed with urosepsis, caused by obstruction of his right kidney • A ureteral stent was placed, but the patient decompensated and went into shock with a sharp rise in the need for vasopressors • IL-6 was 1,000,000 pg/mL. Normal IL
Slide 33: Case Report: Helping in a Tragedy
Case Report: Helping in a Tragedy On October 30, 2015, a night club in Bucharest, Romania caught on fire from pyrotechnics from an inside concert. 27 people died in the blaze, with another 146 people hospitalized with serious burn, smoke inhalation and trauma related injuries. 80-90 of the survivors
Slide 34: 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 34