Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — FY2013 Earnings Presentation
52 slides from Cytosorbents's earnings presentation, Apr 4, 2014
Slide 1: An Emerging Leader in Critical Care Immunotherapy: Fiscal Year 2013 Review
Cyto Sorbents Corporation OTCBB: CTSO An Emerging Leader in Critical Care Immunotherapy Fiscal Year 2013 Review – March 31, 2014
Slide 2: Safe Harbor Statement
Safe Harbor Statement Statements in this presentation regarding CytoSorbents Corporation and its operating subsidiary CytoSorbents, Inc that are not historical facts are forward - looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ
Slide 3: Conference Call Participants
3 Conference Call Participants Dr . Phillip Chan, MD, PhD Chief Executive Officer and President Vincent Capponi , MS Chief Operating Officer Kathleen Bloch, MBA, CPA Chief Financial Officer Dr . Christian Steiner, MD Vice President of Sales and Marketing Christopher Cramer, MS, MBA Vice President of
Slide 4: CytoSorbents is an Emerging Leader in Critical Care Immunotherapy
4 Cyto Sorbents is an Emerging Leader in Critical Care Immunotherapy Leading the Prevention or Treatment of Life - Threatening Inflammation in the ICU
Slide 5: Immunotherapy: A $100+ Billion Market
5 Immunotherapy: A $100+ Billion Market HIGH Immune Suppression Infection Cancer Poor healing Allergy/Asthma/Anaphylaxis Autoimmune Sepsis/SIRS Organ Failure Activate the Immune Response • Vaccines ($30B+ revenue) • Sanofi , Merck, GSK, Pfizer, Novartis • Cancer Immunotherapy ($20B+ revenue) • Ritux
Slide 6: What is the $20B Critical Care Opportunity?
6 What is the $20B Critical Care Opportunity? 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 • In these conditions, little exists to reduce the inflammation and actively help patients get better
Slide 7: Cytokines Fuel the Fire of Inflammation
7 Cytokines Fuel the Fire of Inflammation • Cytokines are small proteins that normally help stimulate and regulate the immune system and control inflammation • Cytokines are a dual edged sword • They are required for proper immune system function • However, in mild to moderate excess, cytokines can
Slide 8: Massive Inflammation Causes Organ Failure
8 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 it today
Slide 9: CytoSorb Removes the Fuel to the Fire
9 Cyto Sorb ® 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 reduce key cytokines in blood by 30 - 50% in critically ill patients • Approve
Slide 10: The Heart of the Technology
10 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 • Protected by 32 issued US patents and multiple applications pending • Manufac
Slide 11: Goal: To Prevent or Treat Organ Failure
11 Goal: To Prevent or Treat Organ Failure Sepsis ARDS Burn Injury Trauma Pancreatitis Influenza Surgical The Potential to Revolutionize Critical Care Medicine Improve Patient Outcome and Survival Decrease Costs Of ICU and Patient Care
Slide 12: $15+ Million in US Government Support
12 • US Dept of Health and Human Services awarded $0.5M grant (2010) for therapies that can save lives and reduce costs under the QTDP Program • NIH grant awarded $7M five year (2006 - 2010) to University of Pittsburgh and Dr. John Kellum to research CytoSorb bead for treatment of sepsis • NIH/NHLBI
Slide 13: 2013 Operating and Financial Highlights
13 2013 Operating and Financial Highlights
Slide 14: CytoSorb: An Excellent Business Model
14 • Huge market CytoSorb ® is sold to hospitals and critical care physicians, targeting a “need to have” $ 20 billion worldwide critical care opportunity addressing organ failure • Little to no competition • Critical care physicians understand the problem • It is a plug and play high margin disposa
Slide 15: 2013 Revenue Results
15 2013 Revenue Results • 2013 was the first full year of CytoSorb ® commercialization • Achieved total 2013 revenue of ~$2.4 million, including product and grant income • 2013 CytoSorb ® sales were ~$822,000 versus $152,000 in 2012 • Q4 2013 CytoSorb ® invoiced orders were ~$351,000. Due to common
Slide 16: Continued Strong Product Growth Since Launch
16 Continued Strong Product Growth Since Launch $13,679 $87,960 $176,098 $127,969 $203,561 $314,159 $0 $50,000 $100,000 $150,000 $200,000 $250,000 $300,000 $350,000 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 CytoSorb ® Product Sales 16
Slide 17: Record CytoSorb Sales Expected for Q1 2014
17 Record CytoSorb Sales Expected for Q1 2014 $13,679 $87,960 $176,098 $127,969 $203,561 $314,159 $530,000 $570,000 $0 $100,000 $200,000 $300,000 $400,000 $500,000 $600,000 Q3 2012 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 PROJ CytoSorb ® Product Sales 17 Maximum and Minimum Expecting Q1 2014
Slide 18: Direct Sales: Germany, Austria, Switzerland
18 Direct Sales: Germany, Austria, Switzerland We are currently working with 100+ KOLs in the largest and most important university and public hospitals in most major cities in Germany and many in Austria and the UK Partial List: • University of Aachen • University of Bonn • Helios Berlin Buch • Cha
Slide 19: E.U. Approval Opens Global Distribution
19 E.U. Approval Opens Global Distribution Signed UK, Ireland, Netherlands, Turkey, Russia and India. Expanding to other parts of Europe and other countries outside the EU that accept the CE Mark Middle East WMC Intensiv Med LLC
Slide 20: Product Sales (TTM)
20 Product Sales (TTM) $151,574 $310,779 $405,706 $595,588 $821,787 $1,195,689 $(100,000) $100,000 $300,000 $500,000 $700,000 $900,000 $1,100,000 $1,300,000 Q4 2012 Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014 PROJ Trailing Twelve Month Product Sales Trend Line Have now exceeded milestone of >$1M TTM Cyt
Slide 21: Strong Gross Margins
21 Strong Gross Margins • Overall 2013 product gross margins exceeded 60% • Sales prices have remained constant • Gross margins will vary based on the ratio of direct sales vs. sales to distributors, but are expected to remain very healthy • Higher scale production is expected to result in lower pro
Slide 22: Working Capital
22 Working Capital Multiple Sources of Capital to Fund Growth • March 11, 2014 receipt of $9,451,000 from our preregistered offering has fortified our balance sheet. • Increasing Product Sales – high gross margins and increasing sales will drive us closer to cash flow breakeven • Continue to receive
Slide 23: Investing in Growth: Catalysts for 2014
23 Investing in Growth: Catalysts for 2014
Slide 24: #1: Core Focus on CytoSorb Sales and Key Opinion Leaders
24 #1: Core Focus on Cyto Sorb ® Sales 100 + Key Opinion Leaders In Germany and Austria Driving Departmental Adoption targeting Junior and Senior Physicians Increase Sales Team + Clinical and Distributor support Reference Hospitals with Expansion to MICU, SICU, CICU, Trauma ICU 30+ Post - Market Stu
Slide 25: Sales Infrastructure Targets For 2014
25 Sales Infrastructure Targets For 2014 Direct Sales Germany Austria Switzerland Direct Sales 5 Distributors (UK, Ireland, Netherlands, Turkey, Russia) 4 sales reps Distributor/Partner Support Rep Targets for 2014 2013 Distributors Partners Distributors Partners Biocon (India) Germany Austria Switz
Slide 26: Market Pull from Key Applications
26 “Market Pull” from Key Applications Use of CytoSorb either during or after cardiac surgery to prevent organ dysfunction and organ failure is a $500M – 1B total addressable market in the US and EU alone Cardiac Surgery Sepsis Afflicts 2.5 million people in the US and EU annually without an approve
Slide 27: Targeting Significant Revenue Acceleration
27 Targeting Significant Revenue Acceleration Revenue Multiplying Effect ~$ 822K 2013 Sales $M: 2014 Sales * Number of cartridges used only to graphically demonstrate the multiplier effect concept. This does not reflect revenue guidance for 2014.
Slide 28: DIVI 2013 First Ever CytoSorb Users Meeting
28 DIVI 2013 First Ever CytoSorb Users Meeting Great energy and excitement from actual CytoSorb users in Germany and Austria • Treatment pioneers from all over Germany and Austria gathered to share their clinical experiences using CytoSorb • Because of the strong interest amongst CV surgeons, there
Slide 29: DIVI 2013 CytoSorbents Sponsored Symposium
29 DIVI 2013 CytoSorbents Sponsored Symposium More than 120 people from Germany/Austria attended in Leipzig, Germany
Slide 30: ISICEM 2014 CytoSorbents Symposium
30 ISICEM 2014 CytoSorbents Symposium
Slide 31: #2: Expand Clinical Trial Capability and Data
31 30+ Investigator Initiated Studies EU Pivotal Sepsis Trial Pivotal Trial Cardiac Surgery European Registry US Air Force Funded Trauma Pilot Case Reports Germany Dosing Study Clinical Trial Manager United States Trials Director of European Scientific Affairs European Trials #2: Expand Clinical Tri
Slide 32: U.S. Cardiac Surgery Pivotal Trial
32 U.S. Cardiac Surgery Pivotal Trial
Slide 33: Rationale for U.S. Cardiac Surgery Trial
33 Rationale for U.S. Cardiac Surgery Trial The path to approval of CytoSorb® in the U.S. is potentially faster, less expensive and less risky than seeking approval for critical care applications such as sepsis • Seeing significant “market pull” for this application. 20+ heart centers in Germany and
Slide 34: U.S. Cardiac Surgery Pivotal Trial
34 U.S. Cardiac Surgery Pivotal Trial 1) Intra - Operative Usage of CytoSorb to Prevent Post - operative C omplications • Multi - center randomized controlled trial • Enrich for cardiac surgery patients at high risk for inflammation and hemolysis and treat DURING surgery with CytoSorb in a bypass ci
Slide 35: Germany Pivotal Sepsis Trial
35 Germany “Pivotal” Sepsis Trial
Slide 36: Treatment Alternatives Continue to Shrink
36 Treatment Alternatives Continue to Shrink Sepsis: • Early Goal Directed Therapy: Early optimization of hemodynamics and oxygenation in septic shock patients failed to demonstrate improvement in 60 - day mortality (21.0% vs 18.2% control) versus usual care in large 1,341 patient U.S. multi - cente
Slide 37: Goal: Increase the Odds of Success
37 Goal: Increase the Odds of Success • CytoSorb is one of the only therapies being used to treat sepsis today in Europe and elsewhere, and holds great promise in early studies. • The European Sepsis Trial and Dosing Study demonstrate that up to 24 hours of treatment is safe. In these patients with
Slide 38: #3: Our Bead Technology Enables a Diverse and Valuable Pipeline
38 Critical Care, High Risk Surgery #3: Our Bead Technology Enables a Diverse and Valuable Pipeline Blood Collection & Transfusion CT Imaging, Interventional Radiology Contrast Sorb Drug Overdose, Chemo Removal Drug Sorb Beta Sorb Improving Dialysis Under Development CE Mark Approved
Slide 39: Potential for Strategic Partnerships
39 Potential for Strategic Partnerships* Cardiac Surgery Renal Dialysis Blood Transfusion Biotech and Immunotherapy Critical Care or Catheters *Companies listed here are used simply as examples of companies in these respective verticals. We make no other representations to our relationship with any
Slide 40: Strategic Partnership: The Most Comprehensive Treatment for Sepsis
40 Strategic Partnership: The Most Comprehensive Treatment for Sepsis Treat the Massive Inflammatory Response Treat the Primary Infection Ms. Kiran Shaw, Chairman and Managing Director of Biocon , India’s largest biotechnology company – Jan 2014 Q3 2014 earnings report: “Our recent launches of Alzum
Slide 41: 2014 and HemoDefend
41 2014 and Hemo Defend ™ Two major trials are expected to be reported in 2014 that may be very important to the HemoDefend platform RECESS (Red Cell Storage Duration Study): • New Blood (≤10 days) vs Old Blood (≥21 days) in 1,696 cardiac surgery patients • Primary endpoint: Change in multiple organ
Slide 42: #4: Uplisting Targeted for 2H 2014
42 #4: Uplisting Targeted for 2H 2014 Increased institutional ownership and liquidity the goal of uplisting to NYSE or NASDAQ • Targeting major operational momentum into 2H 2014 • Revenue Growth with increase in direct and distributor sales • Fixed strategy on US Pivotal trial in cardiac surgery and
Slide 43: #5: CytoSorb is Being Used in a Broad Range of Applications
43 #5: CytoSorb is Being Used in a Broad Range of Applications
Slide 44: Case Report: Septic Shock
44 Case Report: Septic shock 57 year old male was diagnosed with gangrenous appendicitis • Deterioration of clinical course due to severe respiratory failure requiring mechanical ventilation due to suspected pneumonia and aspiration • Transferred to the ICU with septic shock requiring high doses of
Slide 45: Case Report: Intra-op Cardiac Surgery
45 Case Report: Intra - op Cardiac Surgery • 49 year old man developed a graft infection and sepsis, days after aortic arch replacement cardiac surgery • Underwent a re - do operation with CytoSorb in a bypass circuit of the heart - lung machine • Patient was expected to be highly unstable but inste
Slide 46: Case Report: Post-op Cardiac Surgery
46 Case Report: Post - op Cardiac Surgery • 83 year old man underwent quadruple bypass but on Day 8 post - op, he developed pneumonia with septic shock, respiratory and renal failure • The infection was polymicrobial with bacteremia • Treated with CytoSorb and antibiotics • Patient recovered and was
Slide 47: Case Report: Severe Burn Injury
47 Case Report: Severe Burn Injury Patient in his mid - 20‘s suffered severe burn injury with >60% total body surface area and also had severe smoke inhalation injury • Baux (Burn injury severity) Score of 103 predicted mortality of 45 - 50% • Patient was admitted to the ICU after developing shock r
Slide 48: Case Report: Trauma & Rhabdomyolysis
48 Case Report: Trauma & Rhabdomyolysis • 25 year old high speed motor vehicle accident victim admitted with severe polytrauma including hemorrhagic shock requiring massive transfusion, head trauma, a broken leg, chest wall injuries, and others • He was admitted to the neurosurgical ICU and underwen
Slide 49: Case Report: Tylenol Overdose
49 Case Report: Tylenol Overdose A patient overdosed on 30 grams of Tylenol (> 12 g considered to have a very high risk of death due to liver failure and other complications) • The patient subsequently developed multi - organ failure, with failure of the lungs, kidneys and liver, with collapse of th
Slide 50: Case Report: Transport Stabilization
50 Case Report: Transport Stabilization CytoSorb was used with ECMO to stabilize a 58 year old man for transport from Kuwait to a Berlin ICU after a massive heart attack
Slide 51: CytoSorbents is Leading the Way to Prevent or Treat Life Threatening Inflammation
51 Cyto Sorbents is Leading the Way To Prevent or Treat Life Threatening Inflammation • CytoSorb ® targets deadly inflammation in the ICU that leads to organ failure and death • It is approved in the E.U. a nd is generating international revenue • Untapped $20B market opportunity and crucial unmet m
Slide 52: Contact and Q&A Session
52 Phillip P. Chan, MD, PhD - CEO 7 Deer Park Drive, Suite K Monmouth Junction, NJ 08852 pchan@cytosorbents.com Cyto Sorbents Corporation OTCBB: CTSO The Rise of An Emerging Critical Care Immunotherapy Company Q&A Session