Cytosorbents Corporation · NASDAQ:CTSO
Cytosorbents — Q2 2022 Earnings Presentation
40 slides from Cytosorbents's earnings presentation, Aug 2, 2022
Slide 1: Second Quarter 2022 Earnings Conference Call
CytoSorbents Corporation Second Quarter 2022 Earnings Conference Call August 2, 2022
Slide 2: Conference Call Participants
Conference Call Participants Moderator: Amy Vogel 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 – Chief Medic
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: Q2 2022 Operational Highlights
Q2 2022 Operational Highlights • More than 179,000 cumulative CytoSorb devices utilized as of 6/30/22, from >143,000 last year • Announced today the signing of an expanded global marketing agreement with Fresenius Medical Care where CytoSorb will become a featured blood purification therapy on Frese
Slide 6: Stable Core Product Sales in Q2 2022
Stable Core Product Sales in Q2 2022 • Total revenue (product sales and grant income) for Q2 2022 was $8.5M vs $12.0M in Q2 2021 • Product sales were $7.3M (mainly core with negligible COVID-19 sales) vs $11.4M ($9.7M core + $1.7M COVID-19 sales) in Q2 2021 • Q2 2022 core sales were stable with the
Slide 7: Germany Status
Germany Status • In Q2 2022, Germany began recovery from the worst COVID-19 infection surge of the pandemic New COVID-19 Cases and Deaths in Germany Q2 2022 and dealt with another surge in cases during the quarter related to the BA.5 variant • Staffing shortages, budget issues, elective procedure re
Slide 8: Early but Encouraging Signs of Market Improvement
Early but Encouraging Signs of Market Improvement Although not yet showing up in our numbers, we see early, but encouraging signs of improvement, including: • More customer visits in Germany during the quarter • Continued strong positive support from customers, where the feedback on lower orders in
Slide 9: Laser-Focused on 2022 Strategic Objectives
Laser-Focused on 2022 Strategic Objectives As we have discussed previously, we are laser-focused on the following key objectives: • Open the U.S. market by obtaining FDA Marketing approval for DrugSorb™-ATR to remove blood thinning drugs during cardiothoracic surgery through the STAR-T and STAR-D tr
Slide 10: Financial Highlights
Financial Highlights Kathleen Bloch, MBA, CPA Chief Financial Officer
Slide 11: Comparative Quarterly Revenue Results
Comparative Quarterly Revenue Results Quarter Ended Quarter Ended June 30, 2022 June 30, 2021 % Incr. Product revenue $7,330,735 $11,365,450 (35.5)% Grant and other income 1,164,823 658,619 76.9% Total revenue $8,495,558 $12,024,069 (29.3%) • Total revenue, including product sales and grant income w
Slide 12: Total Quarterly Product Sales
Total Quarterly Product Sales Negligible COVID-19 sales in Q2 2022. Product Sales $12.0 $2.5 $1.7 Core Non-COVID-19 Product Sales COVID-19 Sales $10.0 $2.7 $1.8 $1.7 $9.7 $2.4 $1.1 $9.0 $7.6 $0.3 $0.0 $8.0 $8.3 $1.6 $8.0 $7.8 $ IN MILLONS $7.5 $7.3 $7.1 $6.6 $6.5 $6.0 $5.9 $5.7 $5.5 $5.2 $5.1 $4.6 $
Slide 13: TTM Product Sales & Blended Gross Margin
TTM Product Sales & Blended Gross Margin $45.0 $43.3M 85% $8.8 $40.0 82% 78% 80% $33.9M $35.0 76% $3.1 74% $30M $34.5 $1.7 75% $30.0 $4.1 $30.8 $25.0 70% 68% $25.9 67% 65% $20.0 65% $21.0 $15.0 $17.4 60% $10.0 $10.4 55% $5.0 $6.0 $0.0 50% Q2 2016 Q2 2017 Q2 2018 Q2 2019 Q2 2020 Q2 2021 Q2 2022 * Cor
Slide 14: Working Capital and Cap Table
Working Capital and Cap Table Working Capital as of 6/30/2022 3/31/2022 12/31/2021 9/30/2021 6/30/2021 3/31/2021 Current Assets: Cash and short-term investments* $30,164 $43,023 $52,138 $61,043 $65,609 $68,468 Grants and accounts receivable, net 5,171 4,577 4,523 5,241 5,755 5,019 Inventories 4,980
Slide 15: Q2 2022 Cash Burn and Gross Margin Considerations
Q2 2022 Cash Burn and Gross Margin Considerations • Q2 2022 cash burn was approximately $12.9M, which is very high compared to the average cash burn of approximately $5.7M per quarter for the previous five quarters, but was impacted by a number of non-recurrent items • In Q2 2022, $4.8M in non-recur
Slide 16: Additional Q2 2022 Cash Burn Considerations
Additional Q2 2022 Cash Burn Considerations • Since December 31, 2021, we have strategically increased inventory levels, decreasing working capital, in anticipation of production downtime associated with the facility relocation. By the end of 2022, we plan to reduce our inventory by approximately $1
Slide 17: Commercialization Update
Commercialization Update Christian Steiner, MD Executive Vice President of Sales and Marketing Managing Director – CytoSorbents Europe GmbH
Slide 18: Near-Term Growth Drivers
Near-Term Growth Drivers (slide introduced at Q1 earnings call) Focus on key initiatives 1. Resume growth from high active customer base 2. Focus on major applications in key therapeutic areas (critical care, cardiac surgery, and liver/kidney) 3. New exclusive/preferred supplier partnerships / reimb
Slide 19: Resume Growth from High Active Customer Base
1. Resume Growth from High Active Customer Base Active customers in CTSO Direct Business (Depts.) • Number of active customers/users has been stable (ordered in one of last three quarters) • Buying customers slightly down (ordered in last quarter) due to strikes, staff shortages, and blocked ICU bed
Slide 20: Focus on Major Applications in Key Therapeutic Areas
2. Focus on Major Applications in Key Therapeutic Areas • CytoSorb World Users Meeting July 2, 2022 (almost 300 KOLs from 40 countries) • Strong pipeline of new positive data in all therapeutic areas • Cardiovascular • Critical Care • Liver / Kidney • New – Organ transplantation • Continous improvem
Slide 21: Updates on Other Key Initiatives
Updates on Other Key Initiatives 3. New exclusive/preferred supplier partnerships / reimbursement • Asklepios Group and Helios Group • Ongoing discussions in several markets • Updates will be published after finalization 4. Expansion of direct sales footprint • UK subsidiary founded and ready set up
Slide 22: Summary of Developments in Commercialization
Summary of Developments in Commercialization We see encouraging indicators and exciting responses from the markets which we believe will push us forward to new heights in this phase of commercialization • Improved customer access and visibility • Starting pull effect in medical/scientific community
Slide 23: Partnerships
Partnerships Chris Cramer, MBA Vice President, Business Development
Slide 24: CytoSorb Featured Therapy on Fresenius Medical Care Platforms
CytoSorb Becomes a Featured Blood Purification Therapy on Fresenius Medical Care Critical Care Platforms • Fresenius Medical Care (FMC) and CTSO have expanded their partnership via a multi-stage collaboration designed to seize new sales opportunities and jointly develop future innovations • This new
Slide 25: CytoSorb Featured Therapy on Fresenius Platforms (cont)
CytoSorb Becomes a Featured Blood Purification Therapy on Fresenius Medical Care Critical Care Platforms (cont) • FMC will continue to certify compatibility between CytoSorb and FMC’s critical care platforms • CTSO and FMC will form a cross-company commercial and innovation team to work together to
Slide 26: Clinical and Medical Update
Clinical and Medical Update Efthymios N. Deliargyris, MD, FACC, FESC, FSCAI Chief Medical Officer
Slide 27: Making Progress - Increased Focus on Enrollment
Making Progress - Increased Focus on Enrollment • Institutions continue to deal with “long COVID” effects specifically relating to staffing shortages and post-pandemic fatigue • However, our clinical studies have made progress and are now shifting from study start up activities (Phase I) to enrollme
Slide 28: FDA Programs (STAR-T & STAR-D)
FDA Programs (STAR-T & STAR-D) • Both studies with the bulk of sites (>20) now active and recruiting • Operational plans, resources and focus now shifting from study start-up activities (Phase I) to activities driving enrollment (Phase II) • We continue to monitor both studies very closely to determ
Slide 29: Non-FDA Clinical Programs
Non-FDA Clinical Programs PROGRAM Status Next Milestones Target CTC Registry (n=100) US Completed - Data Readouts Presentations 2022 COVID-19 + ECMO ISICEM, EuroELSO, ESICM, ELSO Publications PROCYSS RCT GER Enrolling at >50% of sites Interim Analysis 2023 (n=160) Septic Shock (50% Enrollment) Hep-O
Slide 30: MEDICAL: Positive Data in Critical Care
MEDICAL: Positive Data in Critical Care International Application Peer Review Publications Source Presentations 1 CytoSorb + vv ECMO in COVID-19 - Int J Artif Organs 2022 Akil (Germany) 2 CytoSorb in severe acute pancreatitis - Artif Organs 2022 Rasch (Germany) 3 CytoSorb + ECMO after lung transplan
Slide 31: MEDICAL: Positive Data in Cardiac Surgery
MEDICAL: Positive Data in Cardiac Surgery International Application Peer Review Publications Source Presentations 1 Tica, Apix and Riva removal (Benchtop) ESC ACVC 2021 EHJ CV Pharmacother 2022 Tripathi (CTSO-U.S.) 2 High-risk endocarditis EACTS 2020 PLoS ONE 2022 Haidari (Germany) 3 Case Report – E
Slide 32: Clinical/Medical Summary
Clinical/Medical Summary CLINICAL: • Phase I (start-up) complete with all studies now shifting focus to enrollment • FDA programs remain top priority – Both actively enrolling with 20+ sites. We anticipate accelerated enrollment going forward with critical mass of sites now activated and operational
Slide 33: Facility and DrugSorb-ATR Update
Facility and DrugSorb-ATR Update Vincent Capponi, MS President and Chief Operating Officer
Slide 34: Manufacturing Facility Update
Manufacturing Facility Update • Build out of new facility now complete • Device manufacturing, Chemistry R&D and corporate offices were relocated to new facility end of May per plan • Device production has been successfully started in the new facility generating product that is being sold • Transfer
Slide 35: Product Cost
Product Cost • Production costs increased in Q2 due to shut down of device manufacturing while we transitioned to the new facility, ~ 4 weeks • Manufacturing costs will be higher through the end of the year while we incur additional rent for the old facility until the end of the year when the lease
Slide 36: DrugSorb-ATR Commercialization
DrugSorb-ATR Commercialization • DrugSorb launch team assembled • Project design and development plan outlining all steps through commercialization established – key near term activities: • Branding and packaging for cardiac market • Accessory identification • Finalizing usability requirements • Rai
Slide 37: Team Work
CytoSorhents. | 37
Slide 38: Concluding Remarks
Concluding Remarks Phillip Chan, MD, PhD Chief Executive Officer
Slide 39: Summary
Summary • We are navigating through this period of uncertainty with a focus on tight fiscal management, while investing in our key priorities • Restoration of sales growth • Our U.S. clinical programs, STAR-T and STAR-D • Fully opening our new manufacturing facility • New partnerships to drive growt
Slide 40: Q&A Session
Q&A Session CytoSorbents Corporation NASDAQ: CTSO Company Contact Dr. Phillip Chan pchan@cytosorbents.com 40