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31/05/23
20:37
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Originally posted by Eire2011:
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Hi all, I have been particularly busy lately. Here are a few general thoughts from the AGM. * Seems like a Nasdaq listing is not as much of a priority as it once was. I suspect this is because something commercial may happen before we get to do that. Having said that I met a lady named Bridget who is a contractor hired by AVR to help the company prepare for a listing. * I spoke with all AVR team members present at the AGM. All of them have bought shares. One of them even sold their home during Covid and used the proceeds to buy AVR shares. * The marketing of the company and device is top notch. We are aiming for an Apple like branding presentation and we are achieving that (IMO). * I spoke with Debbie who is the Medical Affairs Officer. Her job is marking to and educating the Dr’s. She is also involved in some regulatory aspects of the company. She was the one that suggested that we create our own class of Valve and helped create the Biomemetic name (a real piece of genius in my mind and may really help with breakthrough status.) * The FDA have helped create a huge problem (they now regret) in approving TAVR for lower (younger) risk patients back in 2019. The problem is becoming bigger and more obvious every day and will only get worse with time as more and more existing TAVRs start to fail. We have some heavy hitters (advocating for DurAVR to be used in VIV asap) working with the FDA and as a result we will include some VIV patients in our EFS study. The hope is that this may lead to some sort of early access permission for DurAVR VIV use. This could have various elements of upside for our company if it all plays out ok. * I feel our MC is not big enough to be acquired at present. However, a partnership may give a company an opportunity to “”lock us up”. Should this option possibility eventuate (prospect of it happening be made public) I feel it may force the hand of others to bid what would be required to acquire us out right. Make no mistake, while some are dissatisfied with our SP movement we have held up remarkably well in the current environment. * I believe we are being closely watched by numerous companies and I think once something starts to happen it could all snowball very fast. Certain companies are not going to want to let others just partner with us or acquire us without a fight. So it’s all quiet until it’s not. * Offers (low ball attempts) have been made previously in non formal ways but have basically been laughed off until they are serious enough (both in value and nature.) But rest assured the dance continues and at pace (20 plus patients is a magic validation number). * V2V is an exciting venture and will provide DurAVR like superior results compared to the incumbents. I am sure we will find out more once we secure some very important patents to protect the tech. * The compassionate case we did was great to hear about. They literally had no other option for this lady and she was going to die in 3 or 4 weeks. We took a slight risk helping her as she was incredibly sick. However, Dr Chris had such confidence in the teams ability and what DurAVR could do that they opted to save her life. Personally I am very proud of this feel good story. Her mean gradient was so high (79) that it could only be restored to 19 due to the damage her arteries had already sustained. It’s good that her numbers are not being included in the study as it would unfairly increase our average mean gradient number that is currently sub 9 (note her EOA was still 2 from memory - brilliant for a small annulus). * The VIV optionality is a significant opportunity and its TAM is not included in the TAM’s mentioned for the first time AS patients. * The company is monitoring the trading in our shares closely for anything that may be a threat. However, you can’t always see the beneficial holder of shares purchased. There was no good explanation offered for the current shuffling that is going on but management are not concerned. * I met and had a good chat with one of our directors Wenyi Gu. He is passionate about AVR and is a smart and personable character. He mentioned the huge market that China will offer the company in the future. * We are pursuing more data on the curative impacts of our near perfect laminar flow on other parts of the heart / body. This data will add to our uniqueness and help build even more of a breakthrough status case. * It’s incredible to hear that our results are so good that some Dr’s literally don’t believe they are true / possible until they see the actual evidence. * A European fund has taken a new position in the top 10. * The market never fully appreciated the significance of the granting of our recent valve patient that basically protects the use of a single piece valve. Wayne was not joking when he referred to it as the billion dollar patent. We basically own “the single piece”. * Wayne is super excited, motivated and keen to continue driving this closer to commercialisation / a transaction of some sort. The value we are creating with each result is immense. It is a case of when now not if DurAVR will be a serious player in the Structural Heart market (whether that’s with AVR or another owner). In summary there is an awful lot going on in the background that we are not entirely privy to. I am personally very comfortable with our current progress, the results we are achieving and the way we are becoming well known by the end users of our device. Our marketing materials and messaging are on point and extremely professional. Personally I will be surprised if some sort of commercial transaction does not occur in the next 12 months but time will tell (let’s face it who really knows!). Meanwhile we head towards the FDA EFS and further value creation. Our DurAVR is now commercial ready. While I know it’s hard for those that need a return sooner than others and those that concern themselves with the day to day share price movement I do genuinely believe that we are on to something special here and patience may be rewarded. DYOR, not advice and all just in my humble unqualified opinion.
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Brilliant. Thank you very much for this comprehensive summary and insight, Eire, it is very much appreciated. A couple of your points that caught my eye.... 1) China, crazy to think that this isn't even entering into the TAM calculations at the moment by industry analysts. China, with a population of 1 billion plus is around 50% bigger than the US and EU combined and is developing rapidly. China will be a massive market in 10 years and should ABSOLUTELY be taken into serious consideration when considering the future prospects of DurAVR sales. 2) Re. doctors not believing or being sceptical of the claims and results achieved by the DurAVR until they see it's performance for themselves reminds me exactly of many investors I talk to about AVR and DurAVR. They too cannot believe or remain skeptical about the results.... This is a hurdle the company will need to overcome in the future although I can understand the skepticism on behalf of doctors and investors because USUALLY if something seems too good to be true it probably is..... although NOT in this case! Still, a hurdle for the company going forwards. 3) Re. Anteris attempting to get early approval for VIV patients I am hopeful about this as many of our doctors and advisory board members are the best in their field and are people the FDA would listen to and if they advocate for DurAVR for VIV patients I think that would count for a lot with the FDA..... although I might be wrong. We'll see! Thanks again, tremendous write up.