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Unhooked - it's all pretty grim here. Q4 / full year results were disclosed in the last quarter conf call - approx $2.9m rev for the year. Seeing as Q1 has now finished they could easily give us a steer on these numbers. I would guess that rev will be c $1m for Q1. Q2 (Oct-Dec) is crucial to say the least.
Ki has automatically started recommending patients to the PCP's that would benefit from having the test, so that should have accelerated adoption!
I have watched the recording.
No new information. Just reiterating their focus on the areas that they have insurance coverage. It is a case of now proving the business model in these areas, ramping up sales and hoping that can be achieved before the cash runs out.
Realistically in order to achieve that they need to half their current cost base, the $2m a quarter trim is not going to make much difference. Say $8m a quarter of expenditure and $3m in sales in calendar yr Q1 would give us time to prove this is a viable growing business going forward.
$8m a quarter expenditure would still cover approx 50 employees etc etc
SB- I think Medicare is likely this year and FDA H1 next year. Medicare is more important. I listened to the Q3 results presentation again. The automation that was talked about is for an automated prompt to PCP's that a patient would be suitable / benefit from the KiX test. A patient won't want the £950 test unless their insurance covers it though. So I think medicare / insurance coverage / automation / real world evidence etc etc should all help drive much higher sales. We need to start gaining sales traction soon.
Oct/Nov/ Dec quarter sales need to be at least $2m and should be achievable with the ins coverage we now have.
SB- It is all very confusing, but per last quarter's results presentation we are hoping to get "medicare coverage, medicare payment this calendar year," Medicare covers the over 65's which is where the bulk of the potential tests are targeted.
I think there are 4 stages to go through to get Medicare - below is an extract from March 2020 presentation
Expected Events
Q1 20 • CPT code 0105U
• $950 price
Q2 20e • CMS contract & provider number
• MolDx coverage submission
Q4 20e • Draft coverage policy & public
meeting presentation
Q2 21e • Coverage policy final
SB - We ramped up sales staff numbers too quickly when there were still many administrative hurdles left to clear. I would guess we have culled the dead wood from the sales team. I'm sure I read somewhere that there were 98 employees in Renx which shocked me. At least a half of these need to go. The current cost savings don't seem high enough......
The recent RNS confirms the narrowing of focus to the areas of potential high demand and insurance coverage.
At this stage, I would cut costs to the bone and concentrate on areas where we have ins converage, get FDA, get Medicare and then raise money once we have a proven model.
Just bought some - They will need cash or a licencing deal in the next 6 mths, but I see sales doubling to about £8m over the next 12mths, which should help with any cash raise licencing deal. Sept R&D should give me more details...
Totally agree unhooked however - "This program was designed to address the evidence requirements of payers, regulators, clinicians, and guideline setting bodies" ie helps with achieving FDA approval, medicare etc etc
I'm guessing that FDA pushed back last year and requested proof that Ki has real world benefits and that has caused the delay.
The hope is that the Ki can identify high-risk patients, which in turn leads them to be automatically asked to come in for a test. Say 1 in 5 them have a high score meaning they are at risk kidney failer. We then automatically contact AZ or whomever we have signed a partnership with to potentially prescribe them some drugs to stop them from escalating to kidney failure/dialysis at a later date. BOOM everyone wins....................
SB - by the sounds of it at this stage the sales force aren't selling, but very much acting in an administrative role to remove barriers in each health care system so we can start selling tests. Clearly, the complexity of getting KI integrated into a health care system, so that a PCP can order a test involves a lot of hurdles.
The automation alluded to in the results presentation (3min.30sec)sounds good if it means that the Ai automatically selects patients that it thinks are high risk and flags them to be sent a letter to come in for a test. That would really up testing.
From the Q3 results earnings call - from 6min 40 sec
"Most importantly utility data is showing that PCP's are 7 times more likely to prescribe guideline-directed therapies to high-risk patients when KidneyIntelx risk assessment was introduced into practice."
That statement seems key to signing those partnerships...........
We have currently $45m in the bank and are burning $15m a quarter. That $15m needs to come down as promised last quarter.
Sales are v disappointing. I was expecting $1m. No growth in a growth stock is a problem...............
Guidance today is required as they already know this quarter's figs ........ They are forecasting from presentation 10,000 tests this calendar year. If I'm reading it correctly 3300 tests performed to date. However, at this stage tests and revenue are not directly correlated.
I'm hoping commercialisation is 6-9mths behind schedule with the recent evidence base real-world figs helping FDA and persuading PCP's to start prescribing the test.
Medicare / FDA and potential partnerships in the next 6 mths should help drive sales....
Miavoce - good point.
No doubt AGL management have spent years plotting the commercial launch of parsortix and have investigated all potential options. An interesting question then is if we signed a deal with Abbott tomorrow how long until we could start seeing parsortix deployed and sales made.
AN seems to have actively down played any significant revenue in the next 2 years !
The question then becomes should AGL have started offering a LDT when they applied for FDA as a strategic decision to start the process of getting reimbursement codes. However, I don't think you can offer a LDT without a certified lab etc ...............
It does feel like AGL have had a primary focus on FDA which was a key milestone, but in reality, was not stopping the sale/ marketing of the test.
Also will AGL be launching a dedicated website for private payers to order the test and get results ??? I can imagine that there would be some off label use ie private payers not just with MBC sending in blood samples. The cassette would be be optimised for MBC, but I think would still catch other CTC's !!
I think the private payer market could quite quickly ramp up with the right marketing.
Presentation 8pm tonight - https://investors.renalytix.com/events/event-details/42nd-annual-william-blair-growth-stock-conference.
Shorting makes much less sense with bio and Renalytix having already been hammered, so hopefully, shorts starting to close. The last thing the shorters want to do is close into strength.
This is a good summary of Renx
https://www.reddit.com/r/Renalytix/comments/v52jn0/rnlx_investment_thesis_nov_2021_version_slightly/?utm_source=share&utm_medium=web2x&context=3
KidneyIntelX, a bioprognostic test for assessing risk of CKD progression, risk-stratified
individuals for kidney, heart failure, and death outcomes in CANVAS.
• Individuals scored as high-risk seemed to derive more of benefit from treatment with
canagliflozin vs. placebo.
• These findings may serve to increase adoption of under-utilized therapies for cardiorenal risk
reduction in patients with diabetic kidney disease
https://kidney360.asnjournals.org/content/kidney360/early/2022/05/18/KID.0002172022.full.pdf?with-ds=yes
canagliflozin = invokana = janssen = Johnson & Johson
Icahn school of medicine buys 9m shares in Renx - insiders buying more :) Following news a big surge in ADR price not really reflected here. US markets closed today.
https://newsfilter.io/a/f23fad5ce6cce2cc1afbcc04758cc600
“Systematically identifying high-risk patients with DKD under primary care at the earliest stages of their disease is essential for improving outcomes, quality of life, and reducing health care cost in the population with kidney disease,” said David C. Thomas, MD, Professor of Medicine, Medical Education and Rehabilitation and Human Performance and Interim System Chair, Department of Medicine, Icahn School of Medicine at Mount Sinai. “We now have the tools, including care navigation, and pharmacy and dietician support, in place to do more than manage the transition to dialysis or transplant. We believe this program will enable advanced support for our primary care teams to help improve the long-term outlook and quality of life for our patients with diabetic kidney disease.”