CytoSorbents Corporation · NASDAQ:CTSO
CytoSorbents — Q1 2015 Earnings Presentation
38 slides from CytoSorbents's earnings presentation, May 11, 2015
Slide 1: CytoSorbents Corporation Q1 2015 Review
CytoSorbents Corporation NASDAQ: CTSO An Emerging Leader in Critical Care Immunotherapy Q1 2015 Review – May 11, 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: Conference Call Participants
Conference Call Participants Dr. Dr. Phillip Chan, MD, PhD Chief Executive Officer and President Vincent Capponi, MS Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Dr. Dr. Christian Steiner, MD Vice President of Sales and Marketing Christopher Cramer, MS, MBA Vice President
Slide 4: CytoSorbents is An Emerging Leader in Critical Care Immunotherapy
CytoSorbents is An Emerging Leader in Critical Care Immunotherapy Leading the Prevention or Treatment of Life-Threatening Inflammation in the ICU using CytoSorb® Blood Purification 4
Slide 5: $20 Billion Opportunity in Critical Care
$20 Billion Opportunity in Critical Care Millions of people are admitted to the intensive care unit in hospitals in the U.S. and the European Union each year with deadly inflammatory conditions Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical • In these conditions, massive inflammation
Slide 6: CytoSorb Removes the Fuel to the Fire
CytoSorb® Removes the Fuel to the Fire • CytoSorb® represents a powerful immunotherapy to control inflammation • 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 • Approved for use in
Slide 7: The Heart of the Technology
The Heart of the Technology The underlying blood purification technology is based on state-of-the-art 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
Slide 8: 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 8
Slide 9: Case Report: Drug Resistant Pneumonia
Case Report: Drug Resistant Pneumonia • A 46 year old man was hospitalized with fatigue, cough and breathing difficulty to a small hospital in Northern Germany • Patient was diagnosed with pneumonia and severe sepsis, and placed on broad spectrum antibiotics. Blood cultures grew out multi-drug resis
Slide 10: Operating and Financial Highlights
Operating and Financial Highlights 10
Slide 11: Comparative Revenue Results
Comparative Revenue Results 2015 2014 % Incr. Incr. Product revenue $ 703,658 $ 569,243 24% Grant and other income 19,416 492,929 (96)% Total revenue $ 723,074 $ 1,062,172 (32)% • CytoSorb® product sales were $703K in Q1 2015, a 24% increase over product sales of $569K in Q1 2014 • Product sales wer
Slide 12: Quarterly Product Sales
Quarterly Product Sales $1,200,000 CytoSorb® Product Sales $1,031,761 $1,000,000 $871,150 $800,000 $703,658 $663,233 $600,000 $569,243 $400,000 $314,159 $203,561 $176,098 $200,000 $127,969 $87,960 $13,679 $0 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 The
Slide 13: Product Sales Growth
Product Sales Growth m8 $3,500,000 $3,000,000 $2,500,000 $2,000,000 $1,500,000 $1,000,000 $500,000 S- Trailing Twelve Month Product Sales $1,750,196 $1,214,932 $821,787 af Q42012 Q12013 Q22013 Q3 2013 Q42013 Q12014 Q22014 Q32014 Q42014 Q12015 CytoSorbents Working to Save Lives Through Blood Purifica
Slide 14: Working Capital and Cap Table
Working Capital and Cap Table 3/31/15 12/31/14 12/31/13 12/31/12 Current Assets: Cash and short-term investments $ 13,358 $ 5,550 $ 2,183 $ 1,729 Grants and accounts receivable, net 673 819 453 51 Inventories 703 538 245 682 Prepaid expenses and other current assets 148 700 605 476 Total current ass
Slide 15: Catalysts of Growth
Catalysts of Growth mode CVtOSorbents lorking to Save Lives Through Blood Purification
Slide 16: #1: Core Focus on CytoSorb Sales
#1: Core Focus on CytoSorb® Sales Working with KOLs worldwide Driving Departmental Adoption 50+ Company Sponsored and Post- targeting Junior & Senior physicans Market Studies Reference Hospitals with Expansion to Strong Direct Sales Team with Reimbursement and Expansion of MICU, SICU, CICU, Trauma I
Slide 17: Targeting Significant Revenue Acceleration
Targeting Significant Revenue Acceleration $M: 2015 Sales and Beyond Revenue Multiplying Effect 2014 Sales * Number of cartridges used only to graphically demonstrate the multiplier effect concept. This does not reflect revenue guidance for 2015. 17
Slide 18: Strong Direct Sales Infrastructure
Strong Direct Sales Infrastructure Sales Rep 5: Sales Rep 6: Signed to start Signed to start early Q3 early Q3 Regional Sales Manager Regional Sales Manager Northeast Germany Northwest Germany Sales Rep 7: Sales Rep 8: Currently Currently Screening Screening 18
Slide 19: Progress on Registration
Progress on Registration • Actively selling product in the E.U. in Germany, Italy, the U.K., Austria, Switzerland, Romania, and the Netherlands, as well as in Turkey and India • Now registered in France, the second largest medical device market in the E.U. • Paves the way for both Fresenius and our
Slide 20: 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 20
Slide 21: #2: Target US FDA Approval
#2: Target US FDA Approval Cardiac Surgery Sepsis and Critical Illness One million open heart Sepsis alone afflicts 2.5 surgeries performed in million people in the US the US and EU each and EU annually without year, representing a an approved therapy. $500M-1 billion market Critical care illnesses
Slide 22: FDA Approval of IDE for REFRESH Study
FDA Approval of IDE for REFRESH Study • REFRESH (R Reduction in FREe FRE Hemoglobin) Trial is a 20-patient multi-center feasibility study evaluating the safety of CytoSorb® use intra-operatively in a bypass circuit in a heart-lung machine during complex cardiac surgery. The goal is the safe reductio
Slide 23: 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 fulfill the following criteria: 1) The medical device is intended to treat a life-threatening or irreversibly debil
Slide 24: Advantages of EAP Designation
Advantages of EAP Designation The first step is to submit an application to the FDA to request EAP Designation. If successful, this has a number of advantages: • CytoSorb® would be given priority status and be assigned an FDA case manager which would facilitate future discussions with the FDA • Vali
Slide 25: #3: Generation of Clinical Data
#3: Generation of Clinical Data Chief VP of Clinical Medical Development Officer Cardiac Sepsis Trauma Surgery Advisory Advisory Advisory Board Board Board Clinical Trial Manager Medical Director of European Statistician United States Trials Director Scientific Affairs 50+ Investigator European Case
Slide 26: #4: Advance Strategic Partnerships
#4: Advance Strategic Partnerships* Critical Care or Cardiac Catheters Renal Surgery Dialysis Biotech and Blood Transfusion Immunotherapy *Companies listed here are used simply as examples of companies in these respective 26 verticals. We make no other representations to our relationship with any of
Slide 27: Strategic Partner Update
Strategic Partner Update • In collaboration with CytoSorbents, Biocon is moving forward with the design and funding of 4 investigator initiated or proof of concept studies and a focused effort to collect and publish clinical data from the field. Biocon is also planning to expand to Sri Lanka, a coun
Slide 28: #5: New Opportunities
5: New Opportunities Bam Working to Save Lives Through Blood Purification
Slide 29: Cytokine Release Syndrome in Cancer Immunotherapy
Cytokine Release Syndrome in Cancer Immunotherapy One of the most promising and exciting areas of cancer research is where: 1) A patient’s own white blood cells (T-cells) are removed from the body 2) Modified with a gene for a chimeric antigen receptor (CAR) that enables it to recognize, proliferate
Slide 30: A Lucrative Market for Deals and Values
A Lucrative Market for Deals and Values As of 5/8/15 Market Cap Juno $4.2 billion Bluebird Bio $5.3 billion Kite Pharma $2.4 billion Intrexon $4.5 billion Cellectis $1.1 billion April 2015 30
Slide 31: Ensuring Safety is A Major Concern
Ensuring Safety is A Major Concern April 2015 31
Slide 32: Juno and Fate Therapeutics Partnership
and Juno recently announced a strategic partnership with Fate Therapeutics, for the screening and development of small molecules that can modulate the biologic activities of activated T-cells. The goal of this program is to develop a pharmacologic “switch” to turn activated T-cells on or off. • Smal
Slide 33: CytoSorb Was Designed to Control CRS
CytoSorb® Was Designed to Control CRS • CytoSorb® was specifically designed to control cytokine storm and cytokine release syndrome (CRS) by reducing the broad range of inflammatory mediators that are driving the systemic inflammatory response syndrome • We believe that CytoSorb® represents a unique
Slide 34: #5: Increased Investor Awareness
#5: Increased Investor Awareness In the near future, we will be meeting with institutional investors in many major cities across the country to increase awareness of our company and technology 34
Slide 35: Continued Positive Analyst Coverage and Investor Outreach
Continued Positive Analyst Coverage and Investor Outreach Current Analyst Coverage: • Brean Capital • H.C. Wainwright • MLV & Co • Merriman Capital • WBB Securities • Zacks 35
Slide 36: Increased Media Coverage
Increased Media Coverage +MASS cytoSorbents inks deal with Fresenius Medical Care (link) By Mark Holmer Mass Device December 16, 2014 MEDICAL DEVICE DAILY" THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE People in the News Medical Device Daily December 24, 2014 Fresenius Medical Care IS slated to distribut
Slide 37: CytoSorbents Has Tremendous Potential
CytoSorbents Has Tremendous Potential ® CytoSorb may help revolutionize critical care medicine, saving lives, and reducing costs • Massive untapped $20 billion unmet medical need in critical care • CytoSorb® sales are generating significant growth with attractive 60+% gross margins • Continued geogr
Slide 38: 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 The Rise of An Emerging Critical Care Immunotherapy Company 38