Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Q2 2024 Earnings Presentation
21 slides from Cytosorbents's earnings presentation, Aug 13, 2024
Slide 1: The Unrecognized Faces of Critical Illness
The Unrecognized Faces of Critical Illness CytoSorbents Corporation Nasdaq: CTSO Q2 2024 Earnings Conference Call August 13, 2024
Slide 2: Conference Call Participants
Moderator: Eric Ribner Conference Call Participants LifeSci Advisors Phillip Chan, MD, PhD Vincent Capponi, MS Chief Executive Officer President and Chief Operating Officer Kathleen Bloch, MBA, CPA Efthymios “Makis” Deliargyris Chief Financial Officer MD, FACC, FESC, FSCAI Chief Medical Officer Chri
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: Recent Operational Highlights
Recent Operational Highlights • More than a quarter million CytoSorb devices have been cumulatively delivered to date, helping to save many lives worldwide • In Q2 2024, Total Revenue increased 5% to $9.9M, while Product Sales increased by 10% to $8.8M, and Product Gross Margins were 75% • Q2 2024 O
Slide 6: Recent Operational Highlights (cont)
Recent Operational Highlights (cont) • Today, we announced Kathy Bloch’s retirement as CFO and the start of our new CFO, Peter J. Mariani starting tomorrow • On track to submit marketing applications in parallel for the investigational DrugSorb-ATR system to FDA as a De Novo application and Health C
Slide 7: Recent Operational Highlights (cont)
Recent Operational Highlights (cont) • Launched the MDR-certified PuriFi Hemoperfusion, placing all 30 pumps in the original order • Expecting delivery on next order from our OEM • Very well-received by users
Slide 8: Financial Highlights
Financial Highlights Kathleen Bloch, MBA, CPA Chief Financial Officer
Slide 9: Comparative Quarterly Revenue Results
Comparative Quarterly Revenue Results Quarter Ended Quarter Ended June 30, 2024 June 30, 2023 % Incr. Product revenue $8,841,789 $8,072,412 10% Grant and other income 1,052,847 1,348,409 -22% Total revenue $9,894,636 $9,420,821 5% • Total revenue, including product sales and grant income was $9.9M i
Slide 10: Comparative First Half Revenue Results
Comparative First Half Revenue Results First Half Ended First Half Ended Y-Y % June 30, 2024 June 30, 2023 Increase Product revenue $17,831,309 $15,982,451 12% Grant and other income 1,849,619 2,887,866 -36% Total revenue $19,680,928 $18,870,317 4% • Total revenue for 1H 2024, which includes both pr
Slide 11: TTM Product Sales & Blended Gross Margin
TTM Product Sales & Blended Gross Margin $45.0 $43.3 80% $40.0 70% $35.0 $33.8 $32.9 60% $29.9 $30.1 $30.0 50% $25.0 40% $20.0 $21.0 30% $17.4 $15.0 20% $10.0 10% TTM 6/30/18 TTM 6/30/19 TTM 6/30/20 TTM 6/30/21 TTM 6/30/22 TTM 6/30/23 TTM 6/30/24 CytoSorb Sales Trendline CytoSorb Sales Blended Produ
Slide 12: 2024 Cash Runway
2024 Cash Runway • Cash balance as of 6/30/2024 was approximately $14.9M, which included restricted cash of approximately of $6.5M. Unrestricted cash as of 6/30/2024 was approximately $8.5M, which is expected to fund the Company’s operations through the second quarter of 2025. • In June 2024, we ent
Slide 13: Clinical and Regulatory Highlights
Clinical and Regulatory Highlights Efthymios “Makis” Deliargyris, MD, FACC, FESC, FSCAI Chief Medical Officer Vincent Capponi, MS President and Chief Operating Officer
Slide 14: DrugSorb-ATR Submission
DrugSorb-ATR Submission • STAR-T clinical study report in final stages of development/publishing • Main data source for De Novo probable benefit and risk analysis • Supportive, supplementary data with RWE from STAR Registry • Completion of technical files (eSTAR) in progress and on track for: • FDA
Slide 15: Real World Evidence with Ticagrelor Removal
Real World Evidence with Ticagrelor Removal 12,000+ Attendees Postoperative Bleeding, UDPB ≥3 • 5 countries; 23 sites; 102 isolated CABG patients 40 • Operated at a mean of 22.8 hours from ticagrelor E-CABG# Registry STAR Registry 35 • Mean CPB duration of 94 minutes (i.e. device use) UDPB 3 ↓ 44% 3
Slide 16: DrugSorb-ATR Filing Status
DrugSorb-ATR Filing Status • De Novo Timeline • Targeting September submission • De Novo eSTAR technical file development – 75% complete De Novo eSTAR Status 25% Completed eSTAR Sections 75% Incomplete/In-Process eSTAR Sections 16
Slide 17: Global Regulatory
Global Regulatory • MDSAP Canada • Audit completed currently undergoing certification review • Receipt of MDSAP certificate is a predicate for regulatory submission • MDR • Targeting December 2024 submission to Notified Body • MDR audit requested for June 2025 • PuriFi Pump Registration • MDR receiv
Slide 18: Closing Statement
Closing Statement Phillip Chan, MD, PhD Chief Executive Officer
Slide 19: Kathleen P. Bloch
Kathleen P. Bloch 19
Slide 20: Peter J. Mariani
Peter J. Mariani CytoSorbents. 20
Slide 21: Q&A Session
Q&A Session NASDAQ: CTSO Company Contact: Investor Relations Contact: Dr. Phillip Chan Eric Ribner – LifeSci Advisors pchan@cytosorbents.com ir@cytosorbents.com 21