Life Science Investor konference, København 26. maj 2021
Præsenteret af Økonomisk Ugebrev
Welcome yeah yes sir nice to hear what you have to say thank you so much fan and um thanks to all of you for being here listening and it feels like i think it’s about seven months ago eight months ago last time and then i thought that things would be normalized and they
Weren’t but here we are and that is really good and my name is per person and i’m very happy to be here to both present and represent acharyax i had the opportunity to share a little bit about the company and our journey when i was here last time
And i like to give you a little bit of an update but of course i also need to give a little bit of an introduction of the company and what we are doing we actually had our birth coming from orbog in denmark with an innovation starting there already in 2004
And i’m not going to take you through every single shot on what happened since then but we had a investment coming from coloplast which i’m sure that you’re all very well aware of and they were you know supporting us a bit then and came part of us when we did our our ipo
And then we’ve had support from a few different investment companies helping us along the journey what i think is really important when you look at this slide and our time axle is actually not only to see what’s happening in terms of investments that part this has also of course been the best
Way for us to have the opportunity to develop our clinical story and what i did just a little bit for fun i actually put a few dots in there to say you know when have we had the opportunity to make publications and a few of the things that are really ongoing
And i think that for those of you who have followed are carrix a while you also know that this is really one of our strengths and that’s also what has been able to to build us to where we are today including the approvals and the discussion you see from regulatory bodies worldwide
So this is of course a very strong effort in itself and then there was the ipo was made at the very late part of 2016 and that’s really when the journey started and then we’ve had really getting more and more of the focus and the commercial work in the development since then
A little bit of the icing and the cake and what has really happened since i was here presenting last time was that we actually were able to obtain our fda approval and of course we are very proud and happy with that and i’ll come back to that in a second
A few things that has occurred aside of the fda approval in itself which we got in the end to part is that we have also been able to get another line of publications coming up and running one of those that is probably the one when you look at the longer terms in the
Pipeline was the study called the um where is it the uh heart failure study the seismo study and of course you know we are really focusing on the coronary artery disease that’s what we have in our bag but i think it’s also interesting for people that look at our company in long
Term to understand that heart failure is of course one of the fastest growing but also very intense and focused uh disease range and we believe that if we can use the technology from cat score to also work and develop the business in that direction we would have a really good
Diversification but today i’m really going to focus on cad score on the journey that we’re doing there so far but some really nice and good events that has been built over time for those of you who are not aware of what cad score is it’s a system that we use and actually
In order to rule out coronary artery disease at the very early stage and i was very interested in in listening to the previous presentation because in a way you can say different motors operando but what it’s really all about is to minimize the pressure on the healthcare
Sector and make sure that the right patients are the ones that are actually getting the more advanced and costly treatments and the ones that should be elsewhere should not actually put pressure on the hospital system in that way you can say that we are doing kind of the same thing
So we’re really helping to rule out patients with potential coronary artery disease from the hospital environment the system itself is placed on the chest of the patient and you’re using a single use patch and this is also within a magnet sling you cannot simply use it more than once
And that’s of course for patient safety but also for uniqueness to the system itself the procedure takes around 10 minutes and it’s also a little bit of a point of care you can actually use the catch call system in almost any environment and that is of course also very important because it
Makes you able to meet the patient at the very very early stage of their journey towards the healthcare system so why would anyone develop such a system and why would you want to do that i think anyone in the room here is aware that cardiac disease is still the number one killer globally
And of course anything we can do to make sure that the patient that is truly suffering from coronary artery disease gets the adequate and the right treatment the better it’s going to be so we also know that even if we are much better now in order to understand
Let’s say the movements around the building zone with obesity diabetes all those factors still coronary disease will be here and it will be a huge part of mankind so anything we can do to work and address on that is of course adding a tremendous value to the healthcare
System but also to the humans and what most people are not aware of is that of all the patients that comes to the healthcare system complaining about stable chest pain they do not suffer from any coronary related issues normally it’s a panic anxiety it can be burnout syndrome
It can be inflammation it can be muscle problems but of course the symptoms are very similar for the patient and of course you have to take those very serious so people are coming to the hospital environment but again about only one out of ten is actually suffering from coronary artery disease
So what we really try to do is to identify those patients as early as possible help the helper system to rule them out and allow the patient that actually have the need to be part of the more expensive and a comprehensive system in itself this is really very important this is really
What we’re all about in in in the work we do wrong direction here we go so just to put this in a little bit more of a let’s say colorful scheme uh in most countries if you look at the the western world if you look at the us if you look
At the others the first thing that would happen with anyone who is you know over the weekend coming into situation we are suffering for from a a stable chest pain you would go to your gp or to your house specialist or maybe potentially anyone in there
What you would do today in most cases is that when they have made their animes you know they do they they’re a little bit of an interview with the patient you know what about heritage in the family what about smoking what about diabetes etc then the physician will have to make a
Decision if they actually want to send the patient for further examination which today normally means put them on a stress bike or send them into a ct examination or even take them for an invasive investigation this is of course adding waiting time it’s putting exposure to the patient in
Terms of radio uh free sprint but it’s also of course adding cost to the husband system so in our world we actually want to use cat score as early as possible in the patient journey so already when they are with the gp or with the households
We want them to use the catskill system and rule out the patient and the way the system is working is actually in i thought i had that slide in here is that you put the measurement on the chest of the patient and you get what we call the cat score
If the cat score is below 20 then it’s safe to send the patient elsewhere not saying that you shouldn’t send them to someone but it’s not in a cardio related disease if they have a cat score that is 21 or above then we suggest you to do a further examination of the patient
That’s really where we want to keep it and that’s really also where it’s going to work and that’s what we’re seeing now when we’re getting a better better uptake in in some of the markets like in germany zone this is really where it adds the benefit towards that
So this is really a simple and good overview of seeing where would cats go fit and where would it work this is also what makes the the system and the concept so easy to understand and of course where you’re going to come is more into other processes where you have the peer-to-peer reviews
And the guidelines in that part and that is for those of you who follow us where we are really spending our energy in a time with some good results to actually get the acceptance and understanding but you also know that these are time-consuming processes you really have
To submit your papers and then follow the works until they are coming there i spoke a little bit about our studies and as you can see we have actually had some strong work on that and just to come back to the fda approval one thing that really made us unique
Here is that we actually obtained our fda approval on de novo and for those of you who know what anova means is that we actually took the clinical data and you should also be able that this is all based on the studies that we have been performing
Here in denmark and that’s also a bit unique because most of the approvals that you obtain through us the fda they always require studies that has been formed on u.s soil so we’re of course extra proud both of the quality in the studied work that we have been doing here in denmark
But also in the fact that they reviewed it and accepted it and said this is good enough for for taking that interest so that’s a very strong thing and then we have a few studies ongoing of course and that’s the one that will actually further uh work and support our in the
Guidelines processes in those things and for and not to forget the the the studies that we’re doing also in in in the other segments when i was here last time i presented this slide and this is actually the same slide and that is because we are very consistent in
Where we keep our focus and we want to get our achievements we have of course since we got the fda approval moved up the priorities in terms of what we’re doing in the us i’m going to share with you a little bit on where we are in the different
Updates there and also in the ongoing discussion we had with the german authorities gba in order to be able to obtain a reimbursement in the german market and then i’ll come back a little bit to the others but really focus today on on the updates on where we are
Based on the announcement c so the fda approval like i mentioned got it at the very last and end of last year and our focus has been firstly to start also in parallel before you have that to look and understand the reimbursement processes in in the us
And you all know that there will be a market that is available for you even without the reimbursement that’s how you can gain and work with the early adopters and that’s also what we are doing successfully in in germany for the moment but of course we also know that the
The way forward is going to be much easier for us if you have a reimbursement pace in the system a few weeks ago i had the opportunity to present to the acc the american college of cardiology and our concept in how we actually want to move ourselves forward in terms of
Getting the various stages of the reimbursement and i’m not going to dwell into the details and spend too much time on that but there is the cpt-1 and the c3 our ambition right now is to obtain the cp3 code it’s very hard to say in english trust me
And by doing that we will actually be part of a reimbursement system but it’s not going to be specific related to our product it’s going to be procedure-related reimbursement the good thing with that is we’ll actually allow any physician to make a choice whether they want to
Use a capscore system or if they want to use else in that toolbox in order to do the rule out procedure of the patients that’s the starting point and what was really good is that as you can see we actually got an endorsement from acc saying that yes
You make the submission and we’re actually going to support you through the process again things take time but if we are actually able to follow this versus two it might mean that we could have the cp3 code already in in the second part of 2022 which is really a fast and rigged put
So good which also means that acc is looking at our data accepting it and reviewing our pathway forward in a positive way another thing when it comes to product supply you know of course anyone who’s investing the company today we announced that we have the fda approval they always say
How come you don’t sell as of day one or day two i would ask the same question but we also have to bear in mind is that obtaining the fda approval means that they have given you the clearance there will still be some homework you
Have to do in order to address the right requirements that you get from fda we’re actually at the point now where we have been passing through that and we can actually start really from a commercial aspect to bring the products into the us market that means that we can accelerate not
Only the work on finding the appropriate distributor channels but we can also start doing our evaluations and product use on u.s soil meaning that we can actually get the patient that we want to fill up in into the into the database also with american patients in
And that’s going to be of course an important step for us forward and that is kind of just around the corner we just need to get the this product shipped and ready for for getting into the u.s market when it comes to the the distribution and sales process
We have made a decision not to start our own sales organization in the us which i think most of you can appreciate looking at the geographical spread and the coverage that we would take on but we’re having a very thorough process in finding a bistress partner that we
Truly work with and build the business over time in the us so that is a process that we are in the midst of and we are using consultancy companies in order to find that kind of partners so things are actually moving on very well for us maybe not at the pace
That anyone from the outside would like but trust me the pressure internally from our side to make this happen is very high and we have a very good feeling of you know seeing a success coming around very soon of course in the meantime we’re also starting with working with advice
Rewards trying to build up the awareness and understanding of catskill into the u.s market trust me they have not seen anything like this and there is of course a different focus and understanding and that takes time to spread it you need podium presence you need more awareness to be created
And that’s what we’re working right now germany which was the second big part that we we addressed and discussed last time is of course to get the reimbursement process in place in germany and we actually started this in the with the kbv in 2018 and then there has been changes in the
Processes in germany and we actually had to go for the regular pathway and go through the gba what’s really good and positive for us is that the ongoing dialogue with gba and we’ve had a few hearings together with them where we have presented our ideas our clinical data and how we
Actually would like to propose to perform a study in germany in order to get the reimbursement versus moving has been very generally positive the expectations from gba when they gave us the the clearance for for coming part of the hearing and the study uh discussions
Was that they would respond to us by the end of uh 2020. here there is nothing to say but pandemic trust me we’ve been really bussing on them and trying to get things moved forward and we had a new hearing with them at the very end of march
And are right now waiting to to get feedback my expectation is that gba would be willing to to start the study in in germany and as i have mentioned many times before there are three different ways of getting the funding in germany for such a study
Either paid by the company paid by a sponsor or paid by gba themselves so that’s really something that looks very promising from us also from a let’s say investment perspective and we’re looking at maybe uh you know a couple of thousand patients at the number of sites
Which of course also will help the accelerated awareness of catscore in the german market on the clinical side i mentioned before we’ve had a few publications coming and the ones that is where we close the enrollment is in the danicad ii we close the enrollment and expect to get
The submission of the publication by the later part of this year and hopefully see a publication coming at the very early part of 2022 the other study that is truly important for us is the filter scad study that is actually driven from pi from here from copenhagen
The filter scout study is the study where we’re actually making a decision it’s where you make an active decision as a physician to use cat score versus any other method so this is really going to be driving from a a statistical significance perspective the usage and evaluation of the capscore
System in the market so that’s some of the large study that’s actually coming around the corner for us right now and then of course the one that i mentioned before the seismo study the one on heart failure and what we’re doing there is that in the first announcement we made we have
Actually decided to extend the study with a few more patients and that is actually a faster way for us to have a fast track in order to get the data that we need to make the publication but also to speed up a development process from our side
So we’re doing all those things really with the good timing in mind even if from the outside it might look like we are delaying it and that’s not the point the point is to make sure that you take advantage of the current population and actually expect expedite the the enrollment process
So if you look at us from the timing i’ve been saying and i said it already last year that there is a lot of things going on with the carricks already in in 2020 for sure this year in 2021 and definitely also into 2022 and
You know the the thing is that it’s a good mix between commercial activities continued uh work on the clinical side but also some of the development side for for uh for new applications and in terms of heart failure etc on the closing point you know why is a
Carrier is going to be an interesting company to work and and invest and look at for 2021 and the continuation of 2022 of course is what i mentioned already the good position we are with regards to develop and get presence into the us market and not only meaning the reimbursement
Side of course also getting the first commercial footprints into the u.s markets secondly a good good looks for for getting a study up and running on the reimbursement side but also more important for those of you who have followers have also seen that even if our baseline
Is still on a low side from expectations perspective you have also seen that we with the changes that i made in the in the german sales organization the last three quarters we actually start to develop a little bit of a better track record where we’re actually getting
Much more systems out in the field and more systems in the field will generate more patch utilization that’s not a secret that’s a razor blade thinking behind what we’re doing and it’s actually a very very good feeling most of those new accounts are coming in germany but we also see them
Coming in in austria and in switzerland so good focus and a good process is also what what’s going to make you successful and we’re of course taking that learning with us into the other markets um a healthy publication we discussed a bit last time about the fact that we got
Our mib you know and a statement made from nice in 2019 and what have we done since then and what have we done to to commercialize and accelerate the process we’ve been working getting a health economic publication and we actually made the final review of that and it’s been
With the reviewers in the uk and we made a submission of that last week so we hope to see that publication coming around and that’s going to give us the new ammunition to go back to nice and say here’s what you asked for this is what we’ve done and here’s the
The proof of the putting so to speak so you know many things happening there as well and of course at the moment we got the fda approval we also got a lot of countries coming towards us saying we would like to represent we would like to work with with the uh
Carricks and the catskill system in our local markets i have been and that’s for good reasons a little bit careful in that approach because we know that we have to do this but it’s also stay focused it’s really a mantra that is really important to me and we know that once you enter
New markets you also have to enter regular through process and no possible very selectful in terms we’re doing what we have done in the meantime is that we have a software now that is available in languages so that we can start working with italy spain netherlands etc so
Good progress and good continuation of where we are there so that’s actually it from acarics today and of course absolutely ready for questions and i promise i’m going to repeat the questions clearly and loudly Thank you how is the economy now are you still catching burn caching or are you starting to earn well we are born of course we are we are a startup company in that mode i will repeat the question thank you thank you are we making money or are we still burning money
And the short answer is that yes we are still burning money and uh i mentioned at several of those meetings that we have a you know a good situation with regards to cash we are able to maintain ourselves into a bit into the late q1 of 2022
So that’s where we are but we also started to see a little bit of a sales pick up in in terms of that as will that be well or will you need more money uh i don’t think that anyone would stand here and commit and say we’re not going
To need any more money that’s of course going to come down to what opportunities that come in front of you as well what we have done and that’s not only for carrots that for many of the companies we have of course been very careful in our spendings during the
Pandemic situation and we’ve done that successfully but at the same time performing clinical investments during clinical studies it is very you know it’s it’s costing money but we’re doing it for all the good reasons and i think that there will be some breakthroughs coming uh in the short term
Organization in q3 last year you saw like 14 and then your phone was 18 units and then back down in the first quarter to 14 minutes what happened there in the first quarter yes i will repeat the question that was my only commitment and i couldn’t keep it
So how come when i say that we actually start to see a little bit of a pickup in terms of sales that then in um in q4 it was 20 something and then it was 14 in q1 my short answer is that is that all companies i’ve been working with you see
Seasonality factor of course when you when you entered into the first quarter now it’s it’s i also said it very clearly it’s not that we are you know exploding in terms that we still have you know the three sales people that are focusing on working on the german market and for me it’s
Actually a huge uptake if you compare to a few of the quarters that we’ve had only in 2019 and also in 2020 with one or two or three systems so it’s moving and what’s important to me is also to really start tracking and follow on how can you increase the patch
Utilization that’s really what i try to focus on with with the german organization but it’s it’s a really interesting remark and i can just say that we of course as any company learning about the targeting in our customers and in the very beginning you kind of tend to focus on the markets where
You’re very common when you look at the the customers and you start to go to the more advanced customers because they would actually understand the concept of rule out what we have done now since we changed the organization in germany is that we are really focusing on the primary care we are really
Focusing on the the let’s say that the more countryside clinics and we actually see much better uptake and understanding in those so you know once we start to spread of course there will be an uptake coming from that alone so just to follow when you break down the installed base
And the number of patches used per unit do you see the standard pattern of a few of your customers using this heavily or some without increasing uptake with a number of passes increasing every month so how do you see these things this time i will repeat the question sorry thank you
A question was whether we actually see the same trends as very often that there is a few accounts that is increasingly the uptake or the patch utilization and there is a few that is really not following that trend right that was the question and the answer is that you are
Absolutely right we start to see that the accounts where they really understand the concept and they really start to to bring in more and more patients because they actually see the benefits that’s also where you will see the update coming up but i think also in a very honest fairness we have also
Gone to a few accounts that has not been correct for us you know you have a physician who likes a an early adopter they really think that the concept is good and great they buy a system they buy a few boxes of patches but they don’t really use it
And that is of course skewing so somehow the the statistics but what i’m doing now with with the german sales organization is that we’re really starting to focus on the accounts they have and really make sure that they can continue to develop the path utilization rather than to find a lot of smaller
Accounts where they wouldn’t have the same name because for us it’s really about having let’s say the spread of the system but of course of having high utilization of the patches last time you were talking about getting out to the small practices also does that mean that
You’re not going that way anymore now you go to bigger users instead no so the question was uh when i was here last time i said that we will actually go for for uh you know these smaller accounts and and not going towards the the the larger hospitals
And that’s exactly what we’re doing we’re actually not going to lost hospitals that is how we’re starting to get success because what you realize is that the places that are rural and and geographically distance that’s the ones where you would actually see huge benefits of having the opportunity to rule out the patient
Instead of you also have to think that also a countryside physician would like to own the patient as long as they possibly can because that’s kind of how they make the money right so what we really understand now is that the more you help them to keep their customers instead of doing a
Reference further into doing more expensive and more complicated examinations the better it’s going to be for them so no the answer is that we really try to focus you know there is also of course a geographical limitation you can’t go to every single village on the countryside in germany and get
The capsule system out there but within let’s say limits and that’s also how we look at it now when we start to understand more of the market situation in the u.s for example you would have the kind of general practitioners they don’t look exactly like the europe
But they would very often be a group they would be like maybe 20 to 30 that are all connected into a common organization and of course if you can get access to let’s say the um the the administration of such a group and get the catskill system in there
That’s the right way forward so uh you know it’s uh the opportunities are tremendous for us time is of course the the fact of life for everybody that we need to work one last question for the gentleman yes and then you briefly mentioned the attaches and utilization can you put
Some numbers on that in terms of distribution than other customers and how many passions you respect the system and where you know well i can but i can’t give you you know i’m not i can’t say that i remember every single patch we have from the
Quarter so but if i look at this as a general trend so in in the very beginning when i joined the company which is just about three years ago there was more of a focus of trying to get systems out there and maybe not considering so much how how much patches
Would actually use what i’ve done now i said i don’t even want the sales organization to go to accounts where they only use maybe you know 10 patches per month that’s not really what we want what we want is to have the accounts where they’re seeing
Let’s say somewhere around 20 to 30 to to up to 50 or 100 patients per month that’s how you will actually get the volumes and that’s also what we see in that trend coming back to to the question from the gentleman in the corner uh on where we actually see a little bit
Of the 80 20 rule and that’s exactly what we do so we see a few accounts we have a good uptake in the number of patches there is a few that is actually using maybe 80 to 100 per month and then of course there would be the
The sites where they use one patch per week and and frankly it’s i mean all sales is good but it’s it’s of also a a cost in maintaining this kind of account so what you really want to do is to have the ones that is working with the concept and understanding the concept
That would be a great client that would be an absolutely great client and i think that within europe it’s kind of hard to find those kind of accounts i think i mentioned when i was here last time we’ve done some um study work in ulm uh together with professor biekemeyer
And that’s actually the acoustic study that’s a private clinic where they see more than 50 000 patients per year so you know they have done an evaluation they have done about 300 patients in in their let’s say small study and they look very positive that system and they have also been
Supportive in our discussions with gba so if you can break through in such an account and at the same time get the reimbursement in place because that’s very important for a private clinic of course that’s when you can start to get these kind of accounts and also in the us we
Know that there are several places where they actually see not only a thousand they see maybe a hundred thousand not in one clinic but i mean in in the uptake area of that and that’s where we want to be definitely okay thank you very much thank you thank you
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