Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Q3 2021 Earnings Presentation
28 slides from Cytosorbents's earnings presentation, Nov 4, 2021
Slide 1: Third Quarter 2021 Earnings Conference Call
CytoSorbents Corporation Third Quarter 2021 Earnings Conference Call November 4, 2021
Slide 2: Conference Call Participants
Conference Call Participants Moderator: Terri Anne Powers CytoSorbents Corporation Phillip Chan, MD, PhD – Chief Executive Officer Vincent Capponi, MS – President and Chief Operating Officer Kathleen Bloch, MBA, CPA – Chief Financial Officer Efthymios “Makis” Deliargyris, MD, FACC, FESC, FSCAI – Chi
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 actu
Slide 4: Q3 2021 Operational Update
Q3 2021 Operational Update Phillip Chan, MD, PhD Chief Executive Officer
Slide 5: Q3 2021 and Recent Operational Highlights
Q3 2021 and Recent Operational Highlights • Q3 2021 total revenue was $9.8M, including product sales of $8.9M, and blended product gross margins were 82%. Balance sheet is solid with $61.0M in cash (9/30/21) and no debt • The U.S. STAR-T pivotal trial has begun with first patient enrolled in October
Slide 6: U.S. COVID-19 Status
U.S. COVID-19 Status Early August 2021 • Migrated to Western US and increasing in the Northeast • 68% of eligible people (12+ yo) are fully vaccinated with 78% with at least 1 dose. 58% of entire population is vaccinated • Highly contagious Delta variant responsible for 99% of new U.S. infections Ea
Slide 7: Worldwide COVID-19 Status
Worldwide COVID-19 Status Early August 2021 Early November 2021 Major increases in vaccinated populations, esp. Europe. Worsening in the UK and Germany but mortality is U.S. lagging other major countries, despite head-start low. High in Eastern Europe and Russia Fully Partially Country Vaccinated Va
Slide 8: Germany COVID-19 Status
Germany COVID-19 Status Q2 2021 Earnings End Call 8.4.21 of Guidance Q3 Germany New Cases Recently, new cases have surged High spike in new cases while deaths, driven by Delta keeps that typically hospitals in restrictions but lag new disproportionately low cases, have severity of illness and rates
Slide 9: Commercialization Update
Commercialization Update Christian Steiner, MD Executive Vice President of Sales and Marketing Managing Director – CytoSorbents Europe GmbH
Slide 10: COVID Situation Reversed During 3Q21
COVID Situation Reversed During 3Q21 • A fourth wave in new COVID-19 cases in Europe, including Germany, accelerated in August through the end of Q3. We observed: • Many hospitals reduced elective surgical procedures, reserved ICU beds and either maintained or reinstituted visitation restrictions •
Slide 11: Current Situation in Q4
Current Situation in Q4 • The macro environment remains challenging in Germany • Significant rise in new cases of COVID • Continued ICU capacity constraints due to staff shortages and resource allocation • Higher vaccination rates not yet reflected in decreased restrictions • But unlike Q3, ICUs are
Slide 12: Increasing Marketing and Promotion
Increasing Marketing and Promotion 12
Slide 13: Increasing Marketing and Promotion
Increasing Marketing and Promotion Setup of broadcasting studio of the 8th International CytoSorb Users Meeting 13
Slide 14: Priorities for Driving Worldwide Growth
Priorities for Driving Worldwide Growth • CytoSorbents is applying a parallel strategy to drive sales • New CytoSorb-in-COVID campaign – clinical results, best practice in treating patients with a focus on patient selection / timing / dosing • Continued promotion of core indications » Critical Care
Slide 15: Clinical Update
Clinical Update Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI Chief Medical Officer
Slide 16: Path to FDA Marketing Approval
Path to FDA Marketing Approval STUDY Status • July - Full FDA IDE approval • August – Study start-up activities ramp up • STAR-T • September – Site activations begin October – Enrollment begins (FPI - University of Maryland) (NCT04976530) • November 4th, 2021 – 6 sites activated • STAR-T methods man
Slide 17: Other Company Clinical Programs
Other Company Clinical Programs Target PROGRAM Latest Update & Status Next Completion PROCYSS RCT GER Recruiting (1 active site) – Ongoing site activation Enrollment 2023* Septic Shock CYTATION GER Enrolling (4 sites active; 3 in GER and 1 in LUX) Enrollment 2022* Ticagrelor Removal Hep-On-Fire GER
Slide 18: Update on Recent Data Releases
Update on Recent Data Releases COVID-19 - Topline U.S. multicenter CTC Registry ECMO results • 90-day survival of 73.1% (n=52, 5 centers). For context, 90-day survival in the North American cohort of the ELSO Registry is 50% (n=5,264, Oct 30, 2021) • CTC data well-received and are expected to drive
Slide 19: Global Clinical Program is Accelerating
Global Clinical Program is Accelerating • Clinical capabilities scaled up significantly in the past 12 months to support our global clinical plan comprised of 9 Company-sponsored clinical studies • Path to US marketing approval focused on the antithrombotic removal opportunity with the 2 IDE-approve
Slide 20: Q3 2021 Financial Highlights
Q3 2021 Financial Highlights Kathleen Bloch, MBA, CPA Chief Financial Officer
Slide 21: Q3 2021 Comparative Revenue Results
Q3 2021 Comparative Revenue Results Quarter Ended Quarter Ended Y-Y % Sept. 30, 2021 Sept. 30, 2020 Trend Product revenue $8.9M $10.2M (13%) Grant income $0.9M $0.3M 185% Total revenue $ 9.8M $ 10.5M (7%) • Q3 2021 product sales were $8.9M, down 13% compared to $10.2M in Q3 2020, driven by lower COV
Slide 22: Quarterly Product Sales
Quarterly Product Sales Product Sales $12.0 $2.5 $1.7 Core Non-COVID-19 Product Sales COVID-19 Sales $10.0 $2.7 $1.8 $8.9M $2.4 $9.7 $7.8 $1.1 $9.0 $8.0 $8.3 $1.7 $7.5 $ IN MILLONS $7.1 $6.6 $6.5 $6.0 $5.9 $5.7 $5.5 $5.2 $5.1 $4.6 $4.0 $4.4 $4.3 $3.4 $3.0 $2.6 $2.6 $2.0 $2.1 $1.9 $1.6 $1.5 $1.1 $0.8
Slide 23: Trailing Twelve Month Product Sales
Trailing Twelve Month Product Sales $45.0 $41.9 85% $40.0 $34.5 $35.0 80% PRODUCT GM % $30.0 $ IN MILLIONS 75% $25.0 $21.6 $19.1 $20.0 70% $15.0 $11.7 $10.0 $7.1 65% $5.0 $3.4 $0.0 60% Q3 2015 Q3 2016 Q3 2017 Q3 2018 Q3 2019 Q3 2020 Q3 2021 Product Sales Blended Gross Margin 23
Slide 24: 2021 Product Revenue Guidance
2021 Product Revenue Guidance • We expect Q4 2021 product revenue to be similar to Q3 2021 product revenue of $8.9M • Full year 2021 product revenue is expected to be at least $39.3M, roughly flat compared to 2020 product revenue of $39.5M • While difficult to predict, 2021 core non-COVID-19 product
Slide 25: Working Capital and Cap Table ($M)
Working Capital and Cap Table ($M) Working Capital as of 9/30/2021 6/30/2021 3/31/2021 12/31/2020 12/31/2019 12/31/2018 Current Assets: Cash and short-term investments $ 61.1 $ 65.6 $ 68.5 $ 71.4 $ 12.2 $ 22.4 Grants and accounts receivable, net 5.2 5.8 5.0 5.2 4.5 3.9 Inventories 4.6 3.7 3.1 2.7 2.
Slide 26: Concluding Remarks
Concluding Remarks Phillip Chan, MD, PhD Chief Executive Officer
Slide 27: Well-Positioned for Long-Term Growth
Well-Positioned for Long-Term Growth • Despite the complexities of COVID-19 on our business, we remain confident in our therapies that have been utilized in more than 152,000 treatments, the core business both in Germany and internationally, and our excellent business model and strong product gross
Slide 28: Q&A Session
Q&A Session CytoSorbents Corporation NASDAQ: CTSO Investor Relations Contact Terri Anne Powers tpowers@cytosorbents.com 28