TM
RenalytixAI
Company Overview
JP Morgan Conference
January 2021
Disclaimer
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The Presentation also contains estimates, projections and other information concerning our industry, our business and the markets for KidneyIntelX and any other products we may develop in the future. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in the information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research, surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Presentation, their estimates, in particular, as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors. Market data and industry information used throughout this Presentation are based on management's knowledge of the industry and the good faith estimates of management. We also relied, to the extent available, upon management's review of independent industry surveys and publications and other publicly available information prepared by a number of third-party sources. All of the market data and industry information used in this Presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Although we believe these sources are reliable, we cannot guarantee the accuracy or completeness of this information, and we have not independently verified this information. While we believe that the estimated market position, market opportunity and market size information included in this Presentation are generally reliable, such information, which is derived in part from management's estimates and beliefs, are inherently uncertain and imprecise.
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JPM 2021 | 1 |
Investment Highlights
FIRST in | Growth Model with Core | Anticipated Near-Term | ||
AI in vitro Diagnostics | Partnerships | Major Events | ||
• KidneyIntelX is first-in-class, clinical | • System population health | • FDA clearance and national roll-out | ||
grade, artificial intelligence-enabledin | ||||
vitro Dx | ||||
• National Medicare coverage under | ||||
• First advanced prognostic in early-stage | MCIT | |||
kidney disease (Stage 1, 2, 3), if | • Integrated care models | |||
approved by the FDA | • Expanding use to broader disease | |||
populations to achieve TAM ~40M | ||||
• Granted FDA Breakthrough Device | patients | |||
designation | • Payor driven | |||
• International markets regulatory review | ||||
• New York State Department of Health | ||||
approved for commercial testing | ||||
• Commercial capable in 50 states | • Precision therapeutic care pathways | |||
• Unique configuration real-time biology + | ||||
EHR features + machine learning | ||||
enabled algorithm | ||||
JPM 2021 | 2 | |||
Key Events Timeline
Q4 18 | Q1 19 | Q2 19 | Q3 19 | Q4 19 | Q1 20 | Q2 20 | ||||||||||
London Stock | First Payor | Received | New York State | |||||||||||||
Exchange IPO | Coverage | $950 Medicare | Commercial | |||||||||||||
(LON:RENX) | Pricing | Testing Approval | ||||||||||||||
FDA Grants | CLIA Authorized | Begin Expanded | ||
Breakthrough | Testing Facility | Payor Coverage | ||
Device Designation | Opens In Utah | |||
CPT Code Granted | Nasdaq | |
for KidneyIntelX | Listing: | |
$85M Raise | ||
*Quarters based on calendar year
Q3 20
Begin Live
EHR
Integration
Partnership with
Final FDA Submission
Q4 20 | Q1 21 | |||
Roll out | Partnership | |||
testing | with | |||
Partnership | Medicare MCIT | |
with | Rule finalized | |
JPM 2021 | 3 |
Unprecedented Size and Cost Drivers in Kidney Disease Market
The Numbers
The
Healthcare
Challenge
The Cost
37 million
Americans currently estimated with CKD
~60 million
adults in the U.S. expected to be diagnosed with diabetes by 2060
>$120 billion
or 20% of Medicare budget spent per year for treatment of CKD (incl. ESKD)
850 million
people estimated with CKD worldwide
100,000
Americans waiting for kidney transplant; 13 die every day
$36 billion
or 6.7% of Medicare budget spent per year for treatment for kidney failure to care for <1% of the covered population
>100,000
Americans begin hemodialysis from kidney failure / year
63%
of patients initiate dialysis in an unplanned fashion ("crash")
$1.3 billion1
can be saved over 5 years per 100,000 patients with
DKD
KidneyIntelX
estimated TAM*
(Initial Indicated Use)
~$12 billion
*Based on one test per patient assuming Medicare national price of $950 per reportable test. Source: McCullough, KP, et al. J Am Soc Nephrol. 2019;30:127-135
JPM 2021 | 4 |
Urgent and Immediate Need to Clarify Who Has Progressive Kidney Disease
1 in 5
will rapidly progress
to kidney failure
Each of these patients has an UACR between 30-299mg/g
Who Is It?
and a GFR of 45-59 ml/min/1.73m2
JPM 2021 | 5 |
KidneyIntelX Enables Precision Prognosis Anchored in Real-time Biology in Early-Stage Kidney Disease
Step 1 | Step 2 | Step 3 | Step 4 | Step 5 | ||||
Blood draw | Data extraction | Algorithms | Reportable result | Care navigation | ||||
Precision | Patient records | Risk score | Clinicians and | Optimized referrals | ||||
Biomarkers | historic + current | analysis | patients | & treatment |
JPM 2021 | 6 |
Clear, Easily Understood Prognosis with Actionable Steps
JPM 2021 | 7 |
Real-World Reactions
Low Risk
" | OMG, this is the best news ever. I am so motivated to bring my number down lower than 40%. I plan to change my eating habits, |
when can I re-test to make sure that my number is heading in the right direction? | |
I'm freaking happy. Thank you, Thank you. I work in a lab, so I know how important it is for me to diet and exercise to maintain or | |
"" | improve my numbers. I would love to be a spokesperson for your program. You people are amazing. |
My sister and mother died from diabetes and kidney problems. I am so happy! Please tell me what I can do to maintain? |
Intermediate Risk
" I am willing to do anything to prevent dialysis, so please tell me what I can do to fix this? How often can I get this test?
High Risk
- This is not good news, but this information can be very helpful. When can I get the test done next. I want to see a nutritionist"
- This is disappointing. What do I have to do to prevent dialysis? Can the doctor up my medications. When can I be tested again?
JPM 2021 | 8 |
KidneyIntelX Could Drive ROI in 12-24 Months
Slowed Progression through CKD Stages
Better risk assessment & patient awareness allows intervention to modify DKD progression
Positive Returns and Cost
Savings for Health Insurers
KidneyIntelX could deliver cost savings of up to $1.3 billion over five years per 100,000 patients with DKD1
Fewer ER Events &
Dialysis Crashes
Advanced warning of acute events allows for planned dialysis
Delayed or Prevented Dialysis & Transplants
Early intervention can delay or prevent dialysis and kidney transplant events
1 Based on the Medicare price of $950 per reportable test
JPM 2021 | 9 |
Potential Near Term Major Value Drivers
- FDA Clearance and National Commercial Roll-Out
- National Medicare Coverage Determination Under MCIT
- Expanded indicated uses into broader disease categories, growing TAM
- Growing body of real-world health economics and utility data
JPM 2021 10
An End-to-End Solution for Kidney Disease
early risk assessment of kidney decline | comprehensive care management | ||||
Help slow kidney disease progression,
improve care coordination and reduce costs
- Anticipated launches in three major markets in 2021
- Expected outcome of the collaboration will also be used to expand indicated use claims for KidneyIntelX
JPM 2021 11
Accretive Innovation to Renalytix Shareholders
• May '20 spin-out from Renalytix; shares | • | Renalytix / Mount Sinai Joint Venture |
distributed to Renalytix shareholders | • | Quantitative COVID antibody testing |
• Kidney transplant Dx portfolio | ||
• | Partnerships | |
• Oct '20 London Stock Exchange IPO (VRCI) | ||
─ Biotechne (NASDAQ TECH) | ||
• Jan 11th market capitalization ~$120M | ─ EKF Diagnostics (LSE EKF) | |
• | Nov '20 CE Mark | |
• Dec '20 FDA EUA | ||
JPM 2021 12
Leadership Team
James McCullough
Co-Founder, CEO
Fergus Fleming
Chief Technology Officer
Dr. Barbara Murphy, M.D.
Non-Executive Director
Tom Mclain
President & CCO
O. James Sterling
Chief Financial Officer
Dr. Steven Coca, DO
Co-Founder
JPM 2021 13
JPM 2021
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Renalytix AI plc published this content on 13 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 January 2021 15:21:06 UTC