Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Q3 2024 Earnings Presentation
23 slides from Cytosorbents's earnings presentation, Nov 7, 2024
Slide 1: The Emergence of CytoSorbents Corporation – Q3 2024 Earnings Conference Call
The Emergence of CytoSorbents Corporation Nasdaq: CTSO Q3 2024 Earnings Conference Call November 7, 2024 DrugSorb-ATR is an investigational device currently under U.S. FDA and Health Canada review. It is not yet approved or cleared in any country.
Slide 2: Conference Call Participants
Conference Call Participants Moderator: Adanna Alexander, PhD ICR Healthcare Phillip Chan, MD, PhD Vincent Capponi, MS Chief Executive Officer President and Chief Operating Officer Peter Mariani, CPA Efthymios “Makis” Deliargyris Chief Financial Officer MD, FACC, FESC, FSCAI Chief Medical Officer Ch
Slide 3: 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 act
Slide 4: Operational Update
Operational Update Phillip Chan, MD, PhD Chief Executive Officer
Slide 5: CytoSorbents at a Glance
CytoSorbents at a Glance • Platform blood purification technology for removing harmful substances from the blood • High margin “razorblade” that is “plug and play” into existing hospital blood pumps • Two main products leveraging the underlying polymer technology o CytoSorb • Treatment of life-threa
Slide 6: Third Quarter 2024 Highlights
Third Quarter 2024 Highlights Solid top line performance of our core international critical care business Improvements in operating efficiencies Continued development of real-world clinical evidence supporting our therapies Key regulatory milestones achieved for DrugSorb-ATR in North America 6
Slide 7: Solid Progress in Third Quarter 2024
Solid Progress in Third Quarter 2024 Metric Performance Product revenue $8.6M, 11% year-over-year growth 61% (planned slowdown and short-term manufacturing issue that was Gross margin resolved in the quarter) Operating expenses 25% year-over-year decrease Operating loss 40% year-over-year reduction
Slide 8: Addresses Unmet Need in Blood Thinner Removal
Addresses Unmet Need in Blood Thinner Removal With the exception of CytoSorb in the E.U., there are no approved reversal agents for Brilinta in the U.S., E.U., or Canada Cardiac surgeons frequently encounter patients on anti-thrombotics needing urgent surgery Guidelines recommend that such patients
Slide 9: STAR-T RCT: Conclusions
STAR-T RCT: Conclusions In the U.S. & Canadian 140-patient pivotal STAR-T RCT evaluating the safety and efficacy of DrugSorb- ATR to reduce the severity of perioperative bleeding in cardiac surgery patients when used within 2 days of Brilinta (ticagrelor, AstraZeneca) discontinuation, the Principal
Slide 10: FDA and Health Canada Decisions Expected in 2025
FDA and Health Canada Decisions Expected in 2025 U.S. FDA Submitted De Novo medical device marketing application to the FDA – Sept 27, 2024 and accepted by FDA in October 2024, initiating substantive review FDA Breakthrough Device Designation makes DrugSorb-ATR eligible for priority review Health Ca
Slide 11: Strong Supportive Clinical Evidence
Strong Supportive Clinical Evidence Submitted real-world evidence from an additional 102 CABG patients on Brilinta to support FDA and Health Canada submissions. Suggests guideline-recommended washout period of a minimum of 72 hours may be substantially shortened with CytoSorb and DrugSorb-ATR STAR R
Slide 12: Potential Win-Win-Win Value Proposition
Potential Win-Win-Win Value Proposition If approved/cleared, DrugSorb-ATR has potential to improve the standard of care in heart attack patients requiring CABG surgery by enabling safe and timely surgery while reducing treatment delays that expose patients to additional risk and consume valuable hos
Slide 13: Attractive Total Addressable Market
Attractive Total Addressable Market Future Opportunity $1-2 Billion Near-Term Opportunity >$600M >$200M >$150M >$450M >$450M Initial Opportunity >$300M • U.S. & CAN Ticagrelor Removal in CABG • DOAC Removal in CABG • DOAC Removal in Hospital-Wide Applications • Expansion of U.S. & CAN • U.S. & CAN T
Slide 14: CytoSorb Benefits Inflammation-Driven Critical Care Indications
CytoSorb Benefits Inflammation-Driven Critical Care Indications COSMOS registry, patient characteristics Data from 150 patients analyzed Critical care indications: septic shock (57.6%) cardiogenic shock (12.9%) rhabdomyolysis (10.6%) Baseline After Baseline After Baseline After CytoSorb CytoSorb Cyt
Slide 15: PuriFi - Easy-to-Use Pump Expected to Drive CytoSorb Growth
PuriFi - Easy-to-Use Pump Expected to Drive CytoSorb Growth ® • Easy-to-use pump supports earlier treatment of patients with CytoSorb without the complex set-up and maintenance of a full dialysis or CRRT machine • Approximately 60 units received through 9/30; • Many are placed or in evaluation with
Slide 16: A Simple and Compelling Value Proposition
A Simple and Compelling Value Proposition Solid top line performance of our core international critical care and cardiac surgery business Improvements in operating efficiencies, margin expansion, with the goal of cash flow breakeven Key regulatory milestones achieved for DrugSorb-ATR in North Americ
Slide 17: Financial Highlights
Financial Highlights Peter J. Mariani Chief Financial Officer
Slide 18: Solid Product Revenue Performance
Solid Product Revenue Performance Metric 3Q24 3Q23 YoY Change Product revenue $8.6 million $7.8 million +11% Grant revenue $0.8 million $1.1 million -27% Total revenue $9.4 million $8.8 million +7% 18
Slide 19: Product Gross Margin to Normalize Through 4Q24
Product Gross Margin to Normalize Through 4Q24 Performance Metric 3Q24 3Q23 Product gross 61% 72% margin 19
Slide 20: Improved Operating Leverage
Improved Operating Leverage Performance Metric 3Q24 3Q23 YoY Change Total operating expenses $9.7 million $13.0 million 25% decrease Operating loss $4.4 million $7.4 million 40% improvement 20
Slide 21: Additional Performance Metrics
Additional Performance Metrics* Performance Metric 3Q24 3Q23 EBITDA loss $1.4 million $8.8 million Adjusted EBITDA loss $3.6 million $5.6 million Net loss $2.3 million or $0.04 per share $9.2 million or $0.21 per share Adjusted net loss $4.5 million or $0.08 per share $6.0 million or $0.14 per share
Slide 22: Cash Conservation – A Top Corporate Priority
Cash Conservation – A Top Corporate Priority Reduced cash burn during the quarter Cash burn was approximately $2.7 million during the quarter versus approximately $5.0 million in Q2 2024 Cash balance as of September 30, 2024 $12.2 million in cash Includes $6.5 million of restricted cash and $5.7 mil
Slide 23: Q&A Session
Q&A Session NASDAQ: CTSO Company Contact: Investor Relations Contact: Dr. Phillip Chan Aman Patel – ICR HealthCare pchan@cytosorbents.com ir@cytosorbents.com 23