Immunovia AB (publ) (IMMNOV) Earnings Call Transcript & Summary

April 1, 2020

Nasdaq Stockholm SE Health Care Health Care Equipment and Supplies special 49 min

Earnings Call Speaker Segments

Operator

operator
#1

Hello, and welcome to the Immunovia presentation. My name is Val, and I will be your coordinator for today's event. Please note this conference is being recorded. [Operator Instructions] I will now hand you over to your host, Mats Grahn, CEO of Immunovia, to begin today's conference. Thank you.

Mats Grahn

executive
#2

Yes. Hello, everyone, and welcome to this call and conference where we will discuss the -- and to make an update how we handle the COVID-19 pandemic at Immunovia. And these days, we are all affected one way or another, and I hope you all listening are well and thanks for joining us today. So far, I would say, in general, we have been handling this very well, and we are in good shape moving forward. And we will look into the different aspects where we have worked to mitigate the impact of COVID-19. As you will see on the slides, the ones of you who are there now should have our agenda in front of you. There are 4 areas I will cover today. We'll talk about the response to COVID-19 pandemic in terms of employees. That's of course, crucial for our operations that we maintain and keep our employees healthy and operational. We'll also talk about suppliers to ourselves of various things. That's very important that we secure our supplies during the -- at least the short and medium-term here. Then we have, for us, the most important, of course, the patients and the clinicians. They, of course, want a test to come to market as fast as possible, and that's in our ambition as well. On the impact on the company, we are, of course, in close collaborations with many clinicians in many sites when it comes to samples and the prospective studies, and we will cover that as well. So that's the first point. The second one will be focused on remaining steps to launch, the verification study and the validation study, in particular. Then we will touch upon the commercial launch preparation activities in terms of prelaunch activities and planning for the sales start and thereafter. And although the prospective studies do not affect the launch, as I have told many times, but it's important for the post-launch reimbursement activities. We will, of course, address the impact on the prospective studies as well during this call. So it's the first 3 points, response to the pandemic, and remaining steps to launch and commercial launch preparation activities that really forms the launch activities, and that's what we will cover now. Starting with the response to the pandemic and how to protect and our employees. First of all, we, of course, follow the guidelines and orders from the authorities in the geographies we are working in presently, mainly Sweden and U.S., of course, and some other countries as well. We have introduced work from home policies already several weeks ago. And that means, of course, that people who are healthy should work from home if possible, and we have many of our employees doing so. And if people have symptoms, it's, of course, mandatory to stay at home. And even though it may be only a cold or flu, it doesn't matter. This is really important, since we have some activities related to our laboratories and production where it's not possible, obviously, to work from home, and we want to protect these areas particularly as far as possible. We have also been lucky enough to work the last years, actually, very distributed and have IT systems in place since long in terms of digital tools, such as Skype for Business and others, and we are very used to it. So it's been for us going into a situation where the infrastructure, IT wise, is well in place and people are trained on it. And thanks to the loyalty and flexibility of our staff, we also have been able very well to cover up for each other when people had to be at home due to symptoms. But this far, we have no reported cases of COVID among employees at all, which is very great. So that's about the work from home policies. And the important thing, if you look upon the Swedish line in the left the slide. For the Swedish operations, which is the R&D laboratories, the clinical laboratories and productions, they are all fully functional and staffed. So we have been very successful in maintaining full operational capacity in these areas. When it comes to U.S., we have, of course, also there, quite a few people from -- especially from the market access, commercial teams working from home, and so forth, and that continues, and we'll touch upon that later. The clinical lab is crucial for us moving forward. It's well prepared with detailed plans for the sales store, what needs to be done. However, the State of Massachusetts have ordered a state-wide shutdown on March 25 and initially to April 7. So that means that all citizens that are not working directly with COVID-19 activities has to stay at home or away from offices and buildings. So if this shutdown is prolonged or not changed in content, it may have an impact on the completion of these plans moving forward. So this area, we, of course, monitor and update plans if necessary going forward, and I'll come back to where it may be affected. So that's the one on employees and the status of the operational units. And in summary, for that one, we have been very fortunate to be able to maintain basically full operation this far with the exception of the last day -- week here for the U.S. lab. When we talk about the next step, which is suppliers. Suppliers is important, of course. We need the reagents, the chemicals, the consumables, and instrumentation for our laboratories and production to be able to operate. And we have had no problems to get supplies this far. We have also taken early precaution by stocking up on all the needed reagents, chemicals, consumables and installation of instruments. So we have done a great job there successfully as stocking up for the future needs, leading up to a launch and commercialization. So that area has been secured well. The second part of that slide is also clinical collaborations. I mentioned that this is very, very important, and that is because that's where we now get our samples from that we use for these studies that move forward. And in general, following national guidelines and regulations that reallocate resources in the hospitals to COVID-19 care, many sites have stopped clinical trials in general for all companies, and that includes sample collection. Even though not all sites are closed, but many, many of them have. And this could have had a major impact, of course. But we are in okay, a very good situation, as I will go through now when we move over to the verification and validation situation on the next slides here. So the remaining steps at the launch, mainly from the technical side, the verification study and the validation study. The first one we are working on right now is the verification study. This is the study where we use the locked signature and algorithms, basically, the -- or really the product as it will be on known samples. It is on track for Q2 completion, as we have announced previously. We have very all the samples in-house in our freezers, and that is thanks to great work done early this year from our clinical collaborators and our teams here to get access to all these samples. And not only for the samples we really need for the verification study, it also has been so well done that we have excess samples more than we need for the verification study that we will use to and allocate to the validation study to mitigate the potential risks there on samples. So verification study running as planned, and all the samples in-house, very, very good. The validation study will follow right after the verification study is completed, and that one is -- the difference between the verification and validation is the validation study is done blinded with independent samples from the verification study, and we have most samples in our hands. There is a focus now to secure transfer on samples that already are collected, but still at the clinical sites. We have, however, also as I mentioned, this is really important, the mitigation by using and transferring the excess samples from the validation collection that will not be used there then since they're not needed to the validation study. And as things stand right now, as of today, we are on track for the Q3 completion of that one as well. That is the good side, really good side. And that's, I would say, we are very fortunate compared to many other companies in life science now when it's very difficult to get access to patients and samples, obviously, given the situation in the health care systems. So that's good. When it comes to the U.S. laboratory, it's important that their plans are performed until we launch, because there is a subset, to say, of these studies that need to be performed in the U.S. laboratory as well for CLIA/CAP validations. And therefore, the shutdown, in general, in Massachusetts will be important for completion that it's not too long, at least for completion of the CLIA/CAP plans. And we will, of course, monitor that situation very closely, and if needed, update our plans and activities on that side. So that's that one. Moving further on to the next area, which is the commercial preparations for a launch that is going on, and of course, since a long time, but especially in terms this year, obviously. You can say that there are basically 3 steps. There is the pre-launch activities, mainly focused on creating awareness that people know about the test, what it does and what's position, and also some educational aspects of it for clinicians and so forth. That's the prelaunch activities. We have the launch itself, which is, of course, the big splashes, and making it very aware that now it's available when it is in Q3. And then we have the post-launch activities that coincide with some of the prelaunch, and these could be things like account mapping now that we do in preparation for sales. Sales training preparations are done before and done as we move forward with the sales force. And that needs to prepare as well. When it comes to the prelaunch activities that goes on right now, there has had to be quite a lot of refocusing to online channels for this one. This is -- the reason for this is obviously that we want to meet our target groups, which means clinical -- clinicians in pancreatologist, gastro clinicians, even primary care clinicians, and that has been planned to a lot of conferences participation, and these conferences are obviously now postponed or canceled in general. Same with the patient organization meetings, these very large meetings with many, many people will not happen until the corona is clearing large meetings. So what is done is to refocus activities on online meetings, conferences, presentations and so forth instead. So there's a big job being done by the marketing and market access teams to do that work right now. And there, we will also increase our digital plans going forward to mitigate for the decreased face-to-face interactions that, obviously, is happening there now. And we do this in cooperation, of course, with the patient organizations and as much as possible the clinicians that are available as well. So what goes on unaffected is the sales preparation and launch preparation activities, preparing for launch. And that is, as I mentioned before, things like account mapping, making sure that the salespeople will have the right tools and training and planning for that. So that was shortly about the commercial launch preparations going on but has had to adjust towards digital measures for the time being and then ready to scale up again as soon as conferences open up or face-to-face interaction becomes possible. To summarize this. We are really in a favorable position compared to many others. As I said, we have most of the things in our hand. We cannot, of course, affect if the whole clinical side is shut down. But we have anyway, this most of the samples in-house, and we are confident that we'll be able to get what we need for the verification and validation studies. So the actions taken successfully to date has really put us in a position that we are able to proceed with most of our operations. They'd adjusted to the reality, so in that sense, I would say we are in good shape. Therefore, the key activities are on target, and we do remain focused completely in the company to launch the IMMray PanCan-d. We, of course, constantly monitor the situation and adjust to any unforeseen circumstances. This has been the case. That we started this early is also the result that we have a good situation. Now we need to maintain that and be very agile in terms of adjusting and adopting as the situation evolves. So -- and it's really important to remember, we have a first to market solution for early detection of pancreas cancer, and we will be first with this one. We -- there's no one else that has a better position in this market moving forward, be it a pandemic or not at the -- which we will, of course, prevail as well. So with that summary, I would like to hand over to Julie and open up for questions.

Julie Silber

executive
#3

Thank you. It's Julie Silber, Director of Investor Relations. Thank you all for joining us on this call today. Before we begin the Q&A section of this call, I wanted to take a few minutes to explain selective or fair disclosure regulations. Since we regularly receive countless inquiries from the market and investors that we cannot answer, we would like to take a little time right now to explain why. The Nordic markets are guided by MAR or the Market Abuse Regulation, which was set forth by the European Parliament on the 16th of April in 2014. This section of MAR that I'd like to highlight today is called Selective Disclosure. This section states that whenever a public company or anyone acting on behalf of a public company disclose nonpublic or insider information to any third-party in the normal exercise of their daily duties that the company must make full disclosure of such information simultaneously in case of an intentional disclosure or promptly in the case of a nonintentional disclosure. This section was largely inspired by REG S-B or Regulation Care Disclosure, which was enacted by the Securities and Exchange Commission in the U.S. in the year 2000. Some of the questions we receive may seem simple and not subject to Selective Disclosure regulations. However, asking for an update or specific details that have not been made public or when a press release will come out or if internal meetings have taken place or discussions have occurred, that does not fall under Selective Disclosure -- I'm sorry, that falls under Selective Disclosure and is not something we can answer. Essentially, if the information has not already been made public via the Immunovia website, in a press release, on our social media outlets or in our corporate presentation, we cannot share it nor can we disclose that information. Thank you for letting me make that point clear. And with that, I would like to now turn the call over to Val to begin our Q&A session, starting first with questions from those who have dialed in to today's call and then we will do the online Q&A. Thank you. Val.

Operator

operator
#4

[Operator Instructions] The first one comes from the line of Michael [ Ofman ], a private investor.

Unknown Attendee

attendee
#5

Have you gotten any more key opinion leaders for your lung and RA studies? And are these studies still on time to be presented during Q2? That's my first question. Second one was, the CTM webinar was postponed due to the expanded patenting possibilities of the study. Have you sent in the extra patenting application yet? And has it been registered?

Mats Grahn

executive
#6

Okay. Michael, so the first question was on our pipeline studies, and we do work on these ones. However, of course, we for obvious reasons prioritize the work on the PanCan-d, and that's for sure. However, we have the samples for lung at hand, and we're working on that and so forth. So we'll update you as soon as we are ready with that. And we have not changed our prediction that it will be done in Q2, as we have said before. And as we said here, we will update when we have information on this one. But I would like to make it clear. When we have any resources, especially now when we have to send people home when they only have a little cold or something, we will always prioritize PanCan-d work. But this far, there has been no change in the previous communication about these projects. That was about the pipeline. When it comes to the CTMS, great data that we have there. The patent attorneys have advised us that they needed quite a lot of more information of detailed nature to be able to make really, really strong patents and maybe wider, as previous before as well, which is extremely positive. This is quite a lot of work. And we will time this when it's done with the potentially also the updates on next study here that's ongoing. Maybe we need that data as well to make it even stronger. We'll see. But you'll have to be really patient on that one. And it's for the good of the company. The patents are crucial, the ones we are putting up now, and they will be very, very good for us.

Unknown Attendee

attendee
#7

Great. How about the key opinion leaders question? Have you gotten anymore [indiscernible]...

Mats Grahn

executive
#8

Sorry. Yes. We will announce as soon as we have deals signed with any key opinion leaders for the pipeline products. But of course, that's, as we have announced before, an ongoing work to get access to what we need in terms of knowledge and samples. And sometimes, activities are going on in a very good way, but the formal legal agreements take a long time and so forth. And that means that we will press release when everything is in place.

Unknown Attendee

attendee
#9

Great. [indiscernible]

Mats Grahn

executive
#10

Yes. I have to add one thing, Michael. Given the situation, in general, in the clinical now, it's not the first priority for clinicians to talk to new players or to add other things because they have many of them, they reallocated. Even if they are experts in various fields, they have been reallocated in many, many of the hospitals to the COVID-19 handling. So that's I think you'll understand. But it's not a standstill. No.

Unknown Attendee

attendee
#11

I'm happy to hear that you have all the samples for the lung study at hand. Does that also apply to the RA studies? Do you have all the samples there as well?

Mats Grahn

executive
#12

We have several ideas going on there, and that will also proceed. And we will talk about it when we have updates for that one. The focus is on the PanCan-d because that is what carries the value for the company mainly. And we need to use all available resources to mitigate, as we talked about in this whole presentation, any potential risk or when people are -- have a flu or cold or whatever, we need to put in people there. So we do not prioritize work in that area if it in any way affects the PanCan-d.

Operator

operator
#13

Our next question comes from the line of Lars Hevreng from Danske.

Lars Hevreng

analyst
#14

Can you touch upon the process of recruiting key personnel? I guess in this phase of the company's development, I guess that's very important to add key people. How does that work in this kind of -- in the general environment?

Mats Grahn

executive
#15

You mean to keep key people?

Lars Hevreng

analyst
#16

No, to hire new people.

Mats Grahn

executive
#17

To recruit? All right. Yes. Well, the willingness to move into companies that have a good future and a good situation and moving forward is strong, even stronger. The only problem in principle is to meet in person. Sometimes it's difficult to travel if you have a travel ban in like in Massachusetts right now. But as we said, we have moved over to digital movements, and we are actually hiring people constantly for our expansion here. We actually are adding people even today, to be honest.

Lars Hevreng

analyst
#18

Yes. That's good to hear. Can I also ask about -- I mean since centers in Spain have been fairly prominent in the Pan study, can you give any indication on what's the situation there in terms of people to be monitored showing up at monitoring events, et cetera?

Mats Grahn

executive
#19

Yes. That's true. Yes. I should have touched upon the situation with the prospective studies as well. Sorry about that. I'll do that now based on this question. Given that sampling has been in most of the centers or many of the centers has been canceled and delayed, of course, and it's not happening, because, first of all, people are not traveling to their appointments, and secondly, because clinicians and staff are reallocated to COVID-19 care or other care that is where personnel has been taken away from. That means that the sampling for particularly PanFAM-1 is affected and will basically be on hold in most centers until the situation clears. So we will have a potential delay on the interim study -- interim readout of the PanFAM-1. When it comes to the PanDIA, the diabetics study, we are not having a delay. And the reason for that is that we have been having a very good collection there and have a lot of samples that will be enough for the interim study as we have planned. So PanFAM, yes, there will be, so to say, a pause or a little break in the collection that will affect the timing. When it comes to PanDIA, it will go ahead as planned. And PanSYM, we are also confident that we will be able to start the interventional studies as planned in the early next year.

Lars Hevreng

analyst
#20

Okay. And regarding the U.K. study, PanSYM?

Mats Grahn

executive
#21

PanSYM has been taken as far as it needs to be in U.K. right now, and we got all the samples already for the optimization and for the validation and verification study in terms of controls and so forth. So next step now, we were actually in a planning mode for interventional adjustments -- adjustments of the studies in PanSYM for the intervention phase. That will, as I said, commence early next year as planned. So that's actually fortunate in that sense.

Lars Hevreng

analyst
#22

Okay. And just finally from my side. The -- it's fairly popular these days to talk about testing capacity, et cetera. How would you describe your situation when we move into the commercial launch? I mean I guess the mechanical testing capacity, that's one thing, but how would you describe in terms of logistics, personnel, et cetera? What kind of volume you can handle?

Mats Grahn

executive
#23

Okay. Yes. Yes. Well, we can handle well the growth that we have anticipated. And it's based on adding lab technicians at the right time to the already in place ones we have. So we are not that concerned about that then because we have the facilities in place, the equipment and so forth and everything. So it's just the right timing. And we have been very successful in attracting that type of personnel historic, so we don't see that as a bottleneck for us going forward after launch or at launch.

Operator

operator
#24

Our next question comes from the line of [ Oscar Nilna ], a private investor.

Unknown Attendee

attendee
#25

My question actually follows up on the one Lars just asked. And that is what is the current capacity of production in the 2 different labs as of today?

Mats Grahn

executive
#26

Well, it's -- first of all, production of -- in production of the slides and so forth, that is around 240,000 tests per year. And that is well in advance of what we will have the first year. If we have that in the first year, that would be great, of course. And then we have a plan how to add, as I said, to the labs up to that level in the current labs over the first years. So there is not any issue to cover the first year after launch with the current setting.

Unknown Attendee

attendee
#27

Okay. Sorry, is that 240,000 tests per lab or...

Mats Grahn

executive
#28

Per year. No, that's full production. So we can deliver that. Yes, per year. And that can -- production can be scaled simply by adding some more source to antibody production and 1 or 2 robots. Each robot adds 120,000 tests capacity. So that's also extremely well prepared. The facilities there are today housing 2 robots. We have actually 3 in total, but 2 for production. And it can house many more if needed. So that doesn't need any extension of the facilities for many years, only adding new robots to the production of slides.

Operator

operator
#29

Our next question comes from the line of Alex [ Gregor ] from Kempen.

Unknown Analyst

analyst
#30

I just have a couple of questions regarding your launch. So looking at Q3, when about in the quarter you would expect to launch? And second question, on pricing. When do you expect to kind of share some more insights into your pricing strategy?

Mats Grahn

executive
#31

First question there. Q3 is our target. That's what we're working for. The focus on that one, as we talked about here, we are on plan. There are some strain, of course, on the time lines due to the shutdown in Massachusetts. And depending on how long that one be, it's probably likely we'll be at the end of the quarter given the shutdown already has taken place for 2 to 3 weeks. So that's what I can say about that. Pricing, we remain at our average selling price going forward on $600 per test. And we will, of course, have different programs in terms of maybe family packages and introduction price to get people hooked and then continuous using and so forth. But that's a normal way to introduce products. But our average selling price going forward should be around $600.

Operator

operator
#32

There are no further questions in the queue from the audio line. [Operator Instructions]

Julie Silber

executive
#33

Well, I can introduce a call that came in through the online version of this conference call. The first question that came in is in regards to reimbursement and the discussions with health insurance providers and government agencies. How are these talks going? Are we comfortable that we meet the criteria? When do we expect a decision from them regarding reimbursement?

Mats Grahn

executive
#34

Well, first of all, thanks for that question. That's the absolute most important work after the launch, so to say. And it will require data from the commercial -- sorry, the prospective studies. That's one thing. We have been clear on that all the time. I just want to repeat that. So the first sales will be after launch now, will be self-pay from individuals and from both the public and private health care systems. There are in all countries various mechanisms to do self-pay already from public and also some private institutions. There are budgets or various mechanisms for that in even in most -- in all countries in Europe, I should say, and U.S. is a completely different thing, of course. So that's important to know. Yes. There are reimbursement discussions going on on many levels. It's one of the main focuses of the market access organization led by our Laura Chirica. We have also not only direct talks to the various organizations in the geographies that we target. But also we have support of experts in this field per country, because you always have to have the best people with the best knowledge and connections when you do this kind of. Plus, that the selection of KOLs that we have built up over the last 5 years is crucial since they are advisers to the patient -- to the reimbursement and so forth. And they are also authors on national guidelines, which will have a very important, how should we put it, impact or input in terms of the decisions that the reimbursement organizations in the various countries make. Yes. I think that's true. Yes. I would just add also that we do use our key opinion leaders and especially the ones that are involved in national guidelines or actually even leading the national guideline committees in terms of the study design because that is ensuring that we do the right things for the insurance companies.

Julie Silber

executive
#35

Great. Thanks. We have one more question on the online version. This question asks, what is our estimated probability for failure for verification or validation studies?

Mats Grahn

executive
#36

Our estimated, do you mean percentage or something? Yes.

Julie Silber

executive
#37

Yes.

Mats Grahn

executive
#38

Well, I would say the large risk minimization technically was already done at optimization study and the CTMS result. So now we have locked everything. We are -- and you know, in the CTMS, we also did run samples from 8 different hospitals, actually. I know it's said 7 in the press release, but it's actually 8, 8 different hospitals. That's one of the aspects that may cause problems. But when you get samples from different hospitals that have been treated somewhat different, it's called pre-analytic variations. We have shown that in the CTMs that that works really well. That was very important from that study. We have also which is unusual, had samples, specifically, the controls, the symptomatic ones, people who have symptoms that could have pancreas cancer but it was something completely different. That's the real clinical situation in these studies in both optimization and the CTMs. And that is another aspect. If you only have data from cancer versus healthy, it is unlikely that that will be the same results as when you try to differentiate cancer from symptomatic patients that have some other disease. And we have shown that we can differentiate pancreas cancer from these symptomatic groups. And that -- not only that, we got all these controls from the real clinical situation of [ gastro side ] and primary care. So when it comes to risk, yes, it's much, much lower now than at any time before, of course. Yes. Okay, it's biology, so there's never 0 risk, but we are very confident that this will be very successful moving forward.

Julie Silber

executive
#39

Can you expand on that a little bit and then compare it to the pharma sense of a failure in a Phase III situation?

Mats Grahn

executive
#40

Okay. Yes. That's a completely different situation, completely unrelated really to us. Pharma products, drugs, they are developed first before you start clinical trials. They're developed using animals basically. And then you have a translation to the human in a Phase II actually for showing any effect and the main effects in Phase III. So there's really -- you don't know. But in diagnostics, and particularly us as well, we work on blood samples from day 1. And that's why I'm stressing this that we have used blood samples representing the real clinical situation in as much detail as possible. That's a huge difference because, in that sense, we have already in our development steps and in our now late studies like the CTMS really, really run it as with samples that represent a true clinical situation. And pharma, it's no other way to do it in pharma because you can't use stuff on -- that's only been developed on animals in big scale on patients. So you do a few studies in beginning and then you have many, many, many in the Phase III first. We had thousands of samples done now already in from various patients in both discovery development optimization and CTMS. So that's just a different world.

Julie Silber

executive
#41

Thanks, Mats. That concludes the online questions. Val, do we have any more questions?

Operator

operator
#42

Yes. There is another question coming from the audio line, and it comes from the line of [ Jack Lynch ], a private investor.

Unknown Attendee

attendee
#43

Thank you for doing this presentation today under difficult circumstances with corona. But a few very quick questions for you. #1 is just getting on to the commercial strategies between now and the impending commercialization in a couple of months' time. Can you give us more information, more detail of what communication you're going to get out there to the media, to the markets about exactly how you're getting a message across about a company that really is quite exceptional? And the research and development that you guys have done is brilliant. It's the best technology in the world. We just need to get this out to the market to really explain it to people, to the media. And just whatever strategies if you have in place to really be able to do that, because it's a story too good not to tell. That's the first question. The second question is research. Whichever research analyst picks this thing up first in a big -- from a major research house is going to be -- is going to look like a star. Is there anyone out there you're talking to that you can discuss with, that there's somebody out there who's got the intelligence and the depth of knowledge and breadth of industry experience to be able to take this on? Because what you're doing is great, but we're not getting the research out there at a very, very high level that I think this completely deserves. So if you can give some information on that, if at all possible. They're really the 2 primary questions.

Mats Grahn

executive
#44

Okay, Jack. The last one was very easy to answer because we had on these calls questions from some of the best analysts in Europe when it comes to this area. So I thank them for being on the call, and that's been great to get your questions so -- during this call even, and we have had many discussions before as well. I know you're very interested in the area. So that's good. That's very important. I agree on that. And we know that many, many that we interact with. So let's see who comes first with -- or sorry, second. Alex has already been first on Kempen, but we have others that may be first in their respective geographies moving forward. So that we look forward to. Right. When it comes to the commercial penetration and awareness. When you have to -- when you want to sell things in this area, you have to own the key people. You have to be part of their organizations. And that's not easy, but we are the only company that really is part of everything that goes on in pancreatic cancer, globally. That is more important than running around to the public at this stage. However, and of course, now we -- once we are moving closer here and awareness becomes more critical in that aspect as well. And that means that the plans from the market access teams and from Laura's team includes mass marketing in terms of even media. And there's push and pull, of course. Push from the risk people and pull from the rest of the clinicians and so forth. So we work on both areas. And you will see now at the right time, very focused, very -- activities when it comes to clinicians and in all 3 levels: pancreatologists, gastroenterologists and also primary care clinicians. We are part of the right organizations. We are in their internal meetings and so forth. And that's how we do that one. The push from risk patients, we have done already quite a lot in the area in collaboration with the patient organizations. We have met some 50,000, 60,000 people in the U.S. only in the last 2 years in that area, face-to-face in their meetings. We have had awareness campaigns even on broad media things, but there will be much more of that. And when you have a test to deliver, because when you go out like in a TV show or whatever, you better be ready to deliver the test as well and not waiting for letting the people wait for half a year until they can order it. So be assured that we have taken a lot of time -- well-timed and with the right tools to reach maximum penetration on this. Then also when it comes to -- if you're referring to investor calls, we have had a non-deal road show, for example, meeting over 100 ones the last half year. So there is a lot of work being put in place there. So that's it.

Operator

operator
#45

There is another question in the queue. A follow-up question from the line of Michael [ Ofman ], the private investor.

Unknown Attendee

attendee
#46

I'm happy to hear that you have all the samples you need for your lung study. Just to clarify. I interpret this as that you have all the samples, both your own study and for the ones that you're doing together with big pharma, and...

Mats Grahn

executive
#47

No. We have the samples for the ongoing study now that we were waiting for a long time in place. That one will be done first. Then based on the results of that one, we'll continue with the key own studies for early detection. And that's what we -- or your second question before was about. That's where we work with several key opinion leaders to secure what we need there moving forward. But we need the results first here as well.

Unknown Attendee

attendee
#48

Great. And the comparing diagnostic study online, when do you think you'll be able to disclose the name of your partner?

Mats Grahn

executive
#49

That I cannot tell. I don't know.

Operator

operator
#50

There are no further questions coming from the other lines. So I'll turn the call back to our speakers.

Mats Grahn

executive
#51

Okay. Thank you. I want to emphasize, we do have the first-to-market solution for early detection of pancreatic cancer at our hands. No one else is even close. They have no chance to get close in the short-term given the situation anyway right now. We will address this for over USD 4 billion opportunity market going forward now. We have a fantastic opportunity to build the company, the value, and in particular to help create much better improved situation for affected patients and giving tools also to the clinicians to make a larger impact in the terms of survival for these patients. That's really the case we're doing. Yes, it's a fantastic financial opportunity, but it's based on that we are doing something that really makes a difference. And the flu or the COVID-19, the coronavirus will go away, but cancer will not go away. So this market is there. This need is there. We are there to be the first one to make a major impact. That's the focus of the company. That's the value of the company. And thank you for being with us on that journey.

Operator

operator
#52

Thank you for joining today's call. You may now disconnect. Hosts, please stay connected and await further instructions.

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