I'll try to give my account as best as I can, but I didn't take detailed notes so it will be a bit scratchy. I'm sure someone else will chime in with a better recollection of events.
The AGM was attended by around 30 shareholders which was more than last year (I didn't attend last year) along with the board of directors and Ryan Laws. Notably, Ron was not in attendance and there was a question on how he was and his involvement (which was none moving forward).
A positive mood in the room and you could sense that Scott and the team were confident with where things were headed.
Stuart Crozier was also in attendance and it was nice to hear from him on some of the questions that were asked.
Scott was very accomodating and friendly to all, I was impressed with his demeanor and I'm glad to have him on board. He said hello to those waiting in the reception prior to the meeting and introduced himself, and remembered those who attended in the previous year.
Upon entering the room, there were chairs around the table and around the back and edges of the room, most which were taken. It's likely that the next AGM will either need to be in a bigger room or they will need to take a desk out for more chairs. They had a wide selection of pastries out the back of the room and Scott was personally going around the room to check if people wanted a bottle of water (sparkling or still), which was very nice of him to do. He seems to be genuinely a nice and considerate guy which is great!
John Keep went about the motions of reading the chairs address and going through the votes, which were strongly supported.
Then it was onto Scott to go through the presentation. A nice moment was when he increased the size of the projector wall but it was still relatively small (because they didn't spend a cent on it), owing to their great capital management.
He spent time going through the slidepack and went throug the 2024 highlights. A few key points and I'll add some QAs that came in the end
- First Responder - there were a couple of questions on this, in particular why the first responder was touted as potentially having BETTER performance compared to Gen 1/Emu. This was primarily because First Responder has more antennas (28) than EMU for full brain coverage. Why was this the case? Well, First Responder is just newer and still needs to undergo additional testing and is effectively 'behind' EMU in timelines. A question came on whether First Responder would potentially cannibalise EMU, and Scott mentioned that the 'cart' model was still something that hospitals found attactive compared to something in a backpack. He also mentioned the EMU would potentially go down the path of more antenna or a retrofit (from my perspective, maybe an EMU 2).
- FDA Engagement - there was emphasis on the continued engagement with the FDA. They were also of the opinion that despite the Trump presidency, this would not impact on anything. Scott pointed out that it may actually be beneficial in terms of getting tech fast tracked rather than actually slowing things down. He mentioned the 150 FDA days which is the standard timeline for the De Novo approval, but that it was not equivalent to calendar days.
- Validation Trial - Two senior executives (including Forough) are currently in the US visiting hospitals to discuss the trial and they have a unit in the US. Scott did mention where they were, but I'll leave that out for now. Ideally starting this in the new year, and reiterated the duration of 6 to 12 months. There was discussion on the minimum target of 80% for sensitivity and specitivity, and this is still yet to be determined until the FDA process starts. That said, even if the device does not meet the criteria, it doesn't mean the end of things, it just means more discussions with the FDA.
- Traumatic brain injury- The market for this is also large. They have not commenced any work on this yet and there are no specific timelines on this. Phillip Dubois explained some of the markers for a traumatic brain injury and what scanning generally looks for, however we have no indication yet on whether EMU can do this or not. He did mention though that that based on some of their work for stroke, it may potentially do a better job that CT/MRI.
- EMvision scanner showcases- Scott mentioned some of the events he attended with the team. At one, they were fielding an enquiry every 10 minutes which was very encouraging. They also have hospitals who have enqured with them out of the blue to take an interest. Scott will be off to the US soon for another event.
- Pricing- There was discussion on slide 7 about pricing for Emu and First responder relative to other machines. Interestingly, Scott mentioned that they don't specify the cost of the Conventional CT and Mobile CT Scanner specifically in the preso to not upset some of the majors (Siemens/GE etc) by doing so. It was picked up that the target price of EMU in the presentation is now $175,000 US compared to the $150,000 US previously discussed (inflation). Some discussion around consumables and service contracts. Scott mentioned that in the first year once we receive approval, it is really about getting our name out there in the market and garnering greater interest along with establishment of the distribution channels. So perhaps the current production facilities will still suffice (my comment).
- Pre validation clinical trial results - this bit goes a bit over my head but i'll try my best. In a nutshell, they are very happy with the results and they are seeing ongoing improvement in the sensitivity and specitivity numbers as they continue to feed more cases into the machine learning algorithm (which is mentioned in the presentation pack). This is very encouraging as this in theory means that the performance numbers should ideally be higher after completion of the US validation trial. They will be able to harvest further ongoing data post FDA approval to continue to improve the algorithim and accuracy. A radiologist attended and asked some questions around the number of incorrectly identified cases, and Stuart mentioned that they are looking into those to get a better understanding of why they were not identified. I'm sure someone else can chime in more around this area.
- Competition and patents - question was asked around competition and Scott mentioned his usual responses around this. In regards to patents, they have patents in place and also are confident about their IP of the technology and how the device is put together.
- Post meeting tour- Scott took shareholders for a tour of the office floor and it was nice to see staff in the office. Another shareholder I met who attended last year commented that it was busier this year with more people. He showed us where they were assembling the First Responder and some of the attennas which were being done in effectively an office suite on the floor given it is early days. We were shown some of the NVDA hardware in a room with air con to keep it cool, and then taken to the assembly area where we met the head of the production. They have capability right now of producing one device a week and they have put together around 12 EMUs. Scott mentioned that they can do up to 3 a week with additional staff, and that would be the equivalent of around $40m of capital equipment. Thoughout the tour, there was one EMU in the boardroom, and a few other EMUs in other rooms. Scott showed us First Responder and how it works in theory and a shareholder went on the table for a demo.
- My thoughts - I was impressed by the team and in particular, it was great to meet Scott and Stuart. They were both very friendly and approachable and happy to talk to shareholders with questions. The meeting gave me further confidence that the board and management know what they are doing and have a very clear and defined pathway to success. They didn't seem to overestimate timelines, and part of me feels that we possibly may be able to get things sooner rather than later in this regard, however who knows in relation to the FDA. There were no questions asked in relation to the shareprice, we all know where it stands. Though with the biggest shareholders in the room, they didn't seem too concerned about this, and they very much are focusing on what they need to do to get things across the line. The next 2 years will be very exciting for the company and I'm glad I attended the event and look forward to coming back in 12 months time. We have a top class and dedicated board of directors and mangement team, who I have every confidence will lead us in the right direction. So it's not a question of if, but when.
(20min delay)