As a long term shareholder it will come as no surprise to most that I am positive on Admedus - soon to be Anteris Technologies Ltd and believe in its future. Therefore, any comments I make should be taken in that light. I have said this before, I appreciate the companies history and I feel for the many investors who are under water (like me) on this stock or who have crystallised their loss. Many have since cut their losses and some like me have decided to continue to hold. Some have bought more and some have just retained what they owned. Everyone is different and we all deal with these situations in our own way and in the context of our own situation. So please DYOR, realise that Admedus is a high risk / high reward play and this is not advice or a recommendation. Some comments are just in my opinion and may not be fact. BTW - Check out the Admedus new website - its looks great. The new name will obviously adopt the A in Admedus.
To make this easier I will just put my thoughts from the AGM in point form:
Its a shame that the audio / visual quality was not as good as it should have been.
Admedus is fortuitous to be in a development stage and not paying for a field force. As such Covid 19 has had a minimal impact.
The biggest Covid 19 impact to date has been a delay in our SAVR trial. Currently 2 patients from 15 implanted.
Manufacturing is doing fine and on schedule
Pleased to see Directors and senior executives take a 25% pay cut from May, this is prudent and should have occurred earlier
The company is a new focused entity now having sold or divested Infusions and the CardioCel business. (Immunotherapies put into administration).
2020 market opportunity for TAVR and SAVR is 4.7 Billion and growing strongly (CAGR 15.6%) and up to 8 Billion by 2025.
The 2019 financial highlights were past tense and largely irrelevant to us growing forward.
We are now eligible for R&D rebates.
Our first SAVR patients results are simply outstanding and far superior to anything else on the market. This patients gradient result is now virtually normal. The results are night and day to the market. Yes only one patient but it follows on from bench testing, sheep trials and now human. Importantly our SAVR result is indicative now of what the valve will also do when in a TAVR as unlike everyone else in the market they are essentially the same valve.
Anyone that has done any research will not be surprised at how many Doctors are calling out the issues of durability in existing implanted TAVR's. This is a reality and has become the main issue as the FDA have recently approved the use of TAVR in younger patients that need a longer lasting valve. This is the sweet spot that Admedus now finds itself in. With over 20,000 patients globally with Adapt inside with no calcification for over 10 years. These patients are mostly pediatric patients as well which typically calcify more due to extreme growth. Our date is real and unparalleled.
Our valve shows no wear and tear on over 450 million cycles (plus 10 years). The comp often start to show degradation at around 150 to 200 million cycles.
Our 3D DurAVR design not only represents a huge cost saving (significantly less sutures) in production but importantly the valve behaves much more closely to our native valve.
The EOA of our valve is a huge success. 2.9! It opens and closes beautifully and with zero DNA it does not calcify and degenerate.
Peak Gradient market = 23 AHZ = 11 Mean Gradient market = 11 AHZ = 5 EOA market = 1.9 AHZ = 2.9 CM squared (a brilliant number)
One look at the quality of our TAVR Advisory Board (and some research as I have completed) and it is astounding that a company of our market size has managed to have these brilliant surgeons and minds work our valve and device. The reputation of these individuals speaks volumes for the company and indicates to me that what we have is real and very valuable. These are genuinely some of the best TAVR Doctors in the world that perform hundreds of TAVR operations a year. A ready made client base who have helped design and build not only the valve but the catheter device as well. The valve and engineering will be superior.
DurAVR may be eligible for FDA Fast Track for registration.
Partnership discussions are advancing.
CBAG Conduit was a very interesting announcement. I cannot verify this (maybe someone else can) but some of my research indicates that the CBAG market could be even bigger than the TAVR as there is no product for sale in the market. I have no doubt that Adapt tissue could be molded to provide a viable solution to avoid having harvest a graft from the human body. Reducing risk, improving recovery time and saving money. We could sell these for between $500 and $1000 or maybe more. If you do the sums on number of operations its massive (10's of thousands a year.)
We have increased our patent filings which protects the IP and adds value to the business. Already 18 filed in 2020 and projected to be 2 X the filings in 2019.
The name change in my opinion is great and will be good for us.
The most important slide was the one around capitalising on the assets:
Discussions are ongoing with several of the large MedTech companies Potential partnership deals could include: • Licensing of ADAPT® technology to existing in-market TAVR and SAVR products (this is huge - the recent FDA approval means that we could potentially get an FDA clearance to use our tissue in approved products - this would have instant revenue potential.) • Supply of ADAPT® treated material for current in-market products (this is huge - the recent FDA approval means that we could potentially get an FDA clearance to use our tissue in approved products - this would have instant revenue potential.) • Co development of DurAVR™ • Co Commercialisation of DurAVR™
Other global districts as potential - Is China a possibility given our larger shareholder?
Capital will be needed and the company believes that it will be achieved in a non delusional manner. Our current market size almost dictates this anyway.
I didn't like the way Wayne handled the 20 Million in 2020 question. Should have just called a spade a spade. However, if we sign a deal we may well get there, just not in the way we envisaged.
Operational cash flow used going forward will reduce but we will still be spending on R & D.
A Nasdaq listing in the future is possible but we are no where near that level at the moment.
All patients for the SAVR trial should be completed by year end and hopefully sooner. Parts of data may be released as we progress.
Animal TAVR studies later this year will be important.
EFS (early in human fees ability study) application expected next year.
We still have LMAT in the background providing some revenue.
We still have the 4C TMVR partnership although not mentioned at the AGM. Shame no one thought to ask a question about this but still some big potential blue sky here.
TGA approval should be this year. Its almost a non event for us now although good for LMAT. I will not hold my breath on this.
So that's a little summary for those that are new to the company, may have missed the AGM presentation or are simply time poor. I think the next 6 months will be very interesting for Anteris Technologies Ltd one way or another. The current cash won't last much longer than that and so a deal may well be imminent. The lack of shares on issue will also be interesting in the event of any good news.
I have been buying and will hold tight but as I said it is high risk and high reward and anyone not happy with the company will as always make their own decisions to buy / hold or sell. Irrespective of what happens I do fundamentally believe that the technology we have is significantly undervalued and appreciated by the market - note - i have said that many times before at more higher share prices.
(20min delay)