Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Q4 2021 Earnings Presentation
30 slides from Cytosorbents's earnings presentation, Mar 8, 2022
Slide 1: Fourth Quarter and Full Year 2021 Earnings Conference Call
CytoSorbents Corporation Fourth Quarter and Full Year 2021 Earnings Conference Call March 8, 2022
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 act
Slide 4: Operational Update
Operational Update Phillip Chan, MD, PhD Chief Executive Officer
Slide 5: 2021 Executive Summary
2021 Executive Summary • Despite pandemic headwinds, 2021 was a good year with sales growth driven by increased CytoSorb utilization and advancement of key objectives • Total revenue grew 5%, product gross margins improved to 80%, and balance sheet remains strong with ~$54M in cash (12/31/21) and no
Slide 6: Worldwide COVID-19 and Vaccination Status
Worldwide COVID-19 and Vaccination Status Early November 2021 Early March 2022 High rates of COVID but severity of 65% of the world population has now had at least 1 illness and peak mortality has declined globally 0.4% vaccine dose and 58% fully vaccinated vs 28% with 1 dose and 14% fully vaccinate
Slide 7: Germany COVID-19 Status (3/8/22)
Germany COVID-19 Status (3/8/22) Germany Germany has recently 3.0% just peaked peak mortality 0.1% peak mortality • New cases of COVID-19 in Germany have only recently peaked at all time highs but severity of illness and rates of death are much lower than before • New cases to drop rapidly soon like
Slide 8: Germany COVID-19 Status (3/8/22)
Germany COVID-19 Status (3/8/22) New reported cases by day Germany Germany has recently Italy 3.0% just peaked peak mortality Spain 0.1% peak mortality France • New cases of COVID-19 in Germany have only recently peaked at all time highs but severity of illness and rates of death are much lower than
Slide 9: Navigating through Global Uncertainty
Navigating through Global Uncertainty • We expect the COVID-19 pandemic will likely burn out in 2022 • Likely will see minor spikes in COVID-19 as restrictions like masks are lifted • But pandemic is likely coming to an end this year, due to natural history of viral pandemics, the very high rates of
Slide 10: We Remain Focused on 2022 Strategic Priorities
We Remain Focused on 2022 Strategic Priorities 1) Advance the high priority STAR-T and STAR-D U.S. clinical trials in pursuit of U.S. FDA marketing approval 2) Targeting 20% or more growth in core CytoSorb sales in 2022 3) Complete the buildout and begin commercial CytoSorb production out of our new
Slide 11: Financial Highlights
Financial Highlights Kathleen Bloch, MBA, CPA Chief Financial Officer
Slide 12: Q4 2021 Comparative Revenue Results
Q4 2021 Comparative Revenue Results Quarter Ended Quarter Ended Dec. 31, 2021 Dec. 31, 2020 % Incr. Product sales $ 9,697,876 $ 11,530,563 -16% Grant income 1,084,320 425,214 155% Total revenue $ 10,782,196 $ 11,955,777 -10% • Total revenue in Q4 2021, which includes both product sales and grant rev
Slide 13: Quarterly Product Sales
Quarterly Product Sales Product Sales $12.0 $2.6 $1.7 Core Non-COVID-19 Product Sales COVID-19 Sales $10.0 $9.7M $2.7 $1.8 $1.7 $2.5 $9.7 $9.0 $1.1 $8.0 $8.3 $1.6 $8.0 $7.8 $7.5 $ IN MILLONS $7.1 $6.6 $6.5 $6.0 $5.9 $5.7 $5.5 $5.2 $5.1 $4.6 $4.4 $4.0 $4.3 $3.4 $3.0 $2.6 $2.6 $2.0 $2.1 $1.9 $1.6 $1.5
Slide 14: 2021 Comparative Revenue Results
2021 Comparative Revenue Results Year Ended Year Ended Dec. 31, 2021 Dec. 31, 2020 % Incr. Product sales $40,108,567 $39,452,502 2% Grant income $3,056,960 $1,552,099 97% Total revenue $43,165,527 $41,004,601 5% • Total 2021 revenue, which includes both product sales and grant revenue, was $43M as c
Slide 15: Annual Product Sales & Blended GM%
Annual Product Sales & Blended GM% $45.0 85% $39.5 $40.1 $40.0 5-Year CAGR: 37% 80% $35.0 PRODUCT GM % $30.0 $ IN MILLIONS 75% $25.0 $22.8 $20.3 $20.0 70% $13.4 $15.0 $10.0 $8.2 65% $4.0 $5.0 $0.0 60% 2015 2016 2017 2018 2019 2020 2021 Product Sales Blended Gross Margin 15
Slide 16: Working Capital and Cap Table ($M)
Working Capital and Cap Table ($M) Working Capital as of 12/31/2021 12/31/2020 12/31/2019 Current Assets: Cash and short-term investments $52,138 $71,422 $12,232 Grants and accounts receivable, net 4,523 5,159 4,467 Inventories 4,766 2,674 2,114 Prepaid expenses and other current assets 2,872 3,198
Slide 17: Focus on Financial Discipline and Flexibility
Focus on Financial Discipline and Flexibility • Core product sales are expected to grow 20% or more, over last year • We remain focused on tight control of expenses and prioritization of capital use • Our spend is fully aligned with our strategic priorities • Key Clinical trials • Sales & Marketing
Slide 18: Commercialization Update
Commercialization Update Christian Steiner, MD Executive Vice President of Sales and Marketing Managing Director – CytoSorbents Europe GmbH
Slide 19: Q4 2021 Sales Improvement from Q3
Q4 2021 Sales Improvement from Q3 • Q4 product sales improved compared to Q3 2022 due to: • Improving macro-environment allowed increase of visit frequency and attendance of congresses and events • Germany started to regain lost business (product sales +45% vs. Q3) • Historically best result of Inte
Slide 20: Current Situation in Q1
Current Situation in Q1 • The macro environment remains challenging in Europe and Germany • COVID-related sales continue to decline (lower severity of illness) • Pandemic-related access restrictions, cancelled congresses and events, reserved ICU beds, limited elective surgeries and high number of in
Slide 21: CytoSorb World Users' Meeting invitation
CytoSorb* erapy YEARS RS CytoSorb ee World Users’ ae Meeting ww It is our special pleasure to personally invite you to the CytoSorb World Users’ Meeting in Berlin on July 2"4, 2022. 2022 marks the 10 anniversary of CytoSorb Therapy and we want to celebrate this milestone together with you. Look forw
Slide 22: Priorities for Driving Worldwide Growth
Priorities for Driving Worldwide Growth • CytoSorbents is focusing on replacing the COVID business with core growth • Increased firepower through expanded commercial/medical teams » Critical Care – Septic Shock, Non-infective vasoplegic shock, Trauma etc. » Cardiovascular – Antithrombotic removal (A
Slide 23: Clinical Update
Clinical Update Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI Chief Medical Officer
Slide 24: Execution and Focus
Execution and Focus Our updated and streamlined global clinical plan comprises of: • 7 Programs (3 RCT, 3 Registries, 1 Pilot study) • US (3): 2 FDA RCT: STAR-T; STAR-D + CTC Registry (EUA) • EU (4): RCT (PROCYSS); Pilot (HepOnFire); Registries (STAR + COSMOS) • Although institutions around the worl
Slide 25: FDA Programs (STAR-T & STAR-D)
FDA Programs (STAR-T & STAR-D) • Both studies have left the station and are actively recruiting patients • Majority of sites now selected with most (>70%) participating in both trials • Enthusiasm is high despite pandemic fatigue, but site staff shortages are real • STAR-D start-up moving faster by
Slide 26: Non-FDA Clinical Programs
Non-FDA Clinical Programs PROGRAM Current Status Next Milestone Target Completed CTC Registry (n=100) US Database locked. Multiple Presentations 2022 COVID-19 + ECMO Publications readouts PROCYSS RCT Enrolling at multiple sites Interim Analysis (n=160) GER 2023 Ongoing site activation (50% Enrollmen
Slide 27: Clinical Summary
Clinical Summary • We have focused our resources to ensure disciplined execution of our top priority STAR-T and STAR-D FDA programs • Institutions globally are still struggling with pandemic fatigue and staffing shortages, but we continue to see high levels of excitement for our studies • Both FDA p
Slide 28: Concluding Remarks
Concluding Remarks Phillip Chan, MD, PhD Chief Executive Officer
Slide 29: Summary
Summary • CytoSorbents has the potential to become a highly profitable medical device company with industry-leading operating profit margins, while helping to solve some of medicine’s most vexing problems • Our business is resilient, and while macro uncertainties continue, we remain well-positioned
Slide 30: Q&A Session
Q&A Session CytoSorbents Corporation NASDAQ: CTSO Investor Relations Contact Terri Anne Powers tpowers@cytosorbents.com 30