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Edited Transcript of IMMNOV.ST earnings conference call or presentation 14-Feb-20 7:30am GMT

Q4 2019 Immunovia AB (publ) Earnings Call

LUND Feb 21, 2020 (Thomson StreetEvents) -- Edited Transcript of Immunovia AB (publ) earnings conference call or presentation Friday, February 14, 2020 at 7:30:00am GMT

TEXT version of Transcript

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Corporate Participants

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* Julie Silber

Immunovia AB (publ) - Director of IR

* Mats Grahn

Immunovia AB (publ) - CEO

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Conference Call Participants

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* Lars Hevreng

Danske Bank Markets Equity Research - Research Analyst

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Presentation

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Operator [1]

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Hello and welcome to the Immunovia Full Year 2019 Results Call. My name is Courtney, and I will be your coordinator for today's event. Please note that this conference is being recorded. (Operator Instructions)

And I will now hand you over to your host, Mats Grahn, to begin today's conference. Thank you.

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Mats Grahn, Immunovia AB (publ) - CEO [2]

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Thank you and it's a true pleasure to welcome you to this telecom conference talking about Immunovia's results in 2019.

2019 was a very successful year. I am extremely proud of the results achieved in the studies done in the early detection of pancreatic cancer for our product, IMMray PanCan-d, both the optimization where we showed fantastic results in all relevant risk groups and the Commercial Test Model study where we stress tested the commercial version and made it ready for the final stretch towards sales starts in Q3 and now 2020.

Great. Thanks to our team, R&D, production, quality. Everybody worked really hard to achieve these results. And at the same time, our commercial teams have worked incredibly diligently to prepare for the launch in many ways, which we'll touch upon today.

These results really opened the way to significantly improve care and survival rates in pancreatic cancer for the first time, actually, in the last decade. We have a strong focus, of course, now going forward on introducing and starting selling the IMMray PanCan-d in quarter 3 2020. So that's a great successful 2019 we are summarizing today.

The agenda for today. I will shortly talk a little bit about finance. I will comment on early detection in the global health care perspective, which is an important trend that goes on and where we are very well focused. I will, of course, touch upon the success studies in pancreas cancer and also go through the commercial focus and the work that's done in that area and, of course, also touch on -- upon the pipeline of earlier studies and applications for the IMMray platform.

So let me start by saying a few word about the finance situation. We have now, at the end of the year, a sum of SEK 263 million at hand. So we are well financed going forward. This last, for us, approximately 1.5 years. The burn rate last year, 2019, was SEK 123 million. And the 1.5 years is calculated with an increased burn rate due to the buildup of the sales structure now as we move into the commercial phase.

Moving forward in the presentation. Let me talk about the early detection and its increasing focus on this, in general, in health care in the world. This is because -- on the higher level because of the cost pressure in society and particularly on the health care side, it is a way to deliver better or equally good care but with much better resource utilization. The earlier you find disease and particularly cancer, the better it is for the patients, the higher survival rates you get and the treatment complexity goes down if you find the cancer early. So purely, for society, the health economy drives the trend towards early detection.

Patient survival is increased. It's supported more and more by the regulatory authorities in simplified or streamlined processes for products that enable early detection. You have increasing trend of governmental and national programs and policies and guidelines that focus on early detection and prevention and so forth. Where 4, 5 years ago, when we started to get serious about early detection in Immunovia, this was not the case in most countries. Now it's in all countries in the Western world, including U.S. and most countries in Europe as well.

For the payer side, the insurance systems. Of course, better outcome with less cost per patient is a very important parameter, and that is not achieved without early detection. For the hospitals, the caregivers, better outcome with less cost per resource is, of course, important. We all know that the health care systems are resource-strained. And with early detection, you will be able to get much better care in total with the existing resources.

Even pharma has an interest in early detection since treatment will have a better efficacy, and the drugs will work better if you find patients early. So all in all, early detection is -- has an increased focus all over the health care stakeholders. And Immunovia's IMMray platform is in an excellent position now to contribute with solutions for these needs.

As you know, we are measuring immune system's response to disease in a single drop or blood. And that is also important that you can easily access the specimen, in this case, a standard blood draw to do your -- to get your valuable early detection of cancers.

And we have advantages in the technology whereas the immune system is the first things to react in the body. And there are complementing technologies such as collecting tumor DNA, sometimes also called liquid biopsies. They are very good. But for other purposes, mainly characterizing the tumor, which is important to find out which drug, is the most optimal to use. They have less applicability when it comes to early detection since there are few molecules to measure on in the bloodstream, and that is more difficult, pure biologically, for these technologies. Whereas we have the advantage of matching immune system's response to disease, giving us a much wider window to find solutions. So these technologies complement each other, and we have a platform that truly has a fantastic position in this trend going forward.

You're all aware that our focus is on pancreas cancer, and the product is there to find pancreatic cancer early. Today's situation, I want to repeat it even if you heard it, most of you many times, but it's crucial to remember that we have a situation where there is no solution on the market at all. Today, people who do get diagnosed in pancreatic cancer get their diagnosis too late. 80% cannot be treated at all and only have 4.5 months median survival. Whereas if you find it in stage I, you have up to 50% 5-year survival, meaning that earlier diagnosis will give a much better and higher impact on survival rates than any drugs could ever make. Plus the fact, of course, that if you find them earlier, more modern drugs may have a better chance to be efficacy -- have high efficacy.

So who to test? The ones we are going to test are people who have higher risk of getting pancreatic cancer. To the left, you see the focus of the people with close relatives. The hereditary/familiar group, these are -- were the ones with 1 or 2 or 3 close relatives that have been affected of pancreatic cancer, meaning that themselves have a high risk, and they should be screened lifelong basically from 45, 50 years old to be able to find the cancer early and have a much better chance of survival. However, only 10% of pancreatic cancer cases come from this group, so you have to address the 90% that are sporadic as well.

To the right on this screen, you see something called NOD, new onset diabetics. That means that new people with the first diagnosis of diabetes type 2 over 50, close to 1%, will get a pancreas cancer diagnosis within 3 years after the diabetes diagnosis. And that is an opportunity to diagnose the cancer for the ones who are affected 1 to 1.5 years earlier than today, meaning it's, in most cases, the difference between treatable and nontreatable. This is a very large group. And it's also the strategy of, for example, National Cancer Institute in U.S. and others. However, there is no tool today available to do that. That's what we are providing. And that is a very big opportunity, significantly to have large numbers of people being found earlier.

There is also a need for differential diagnosis. We also call it early symptoms. People have symptoms also in stage I and II. They are hard to distinguish from other states, other diseases or conditions. So using the test for a rule-in/rule-out and differentiate the ones that actually have pancreatic cancer, both in the gastro centers and in some health care systems that are trying to push this out into primary care is really truly important. So the middle part there is a differential diagnosis use of the test, which has a great flexibility as well.

Looking at the market size for these 3 different groups. We see that familiar/hereditary is the smallest. However, it's also the one that is most aware of their situation, and that's why it's extremely interesting from the company's perspective to address their needs. It was one of the first possible uses as we launch it to the market. The differential diagnosis mainly in the gastro centers and in some primary care situations moving more and more into that situation is a truly important area as well, accessible also at launch here.

The new onset diabetics, very big opportunity. And that's, of course, a bigger task to push it out to everyone who sets the diagnosis for diabetes, but it also will give a major impact, positive impact on finding people earlier.

So the total market only in Europe and U.S. is a maximum of USD 4.4 billion. And we are there now with the first test that works in this area, launching it in quarter 3 with fantastic data. So it's a great situation and a fantastic market opportunity for the company moving into commercial stage right now, 2020.

So let's move forward and talk about the great results that we had in 2019 with IMMray PanCan-d. We have run the 2 studies that are called the optimization study where we did achieve the right results that we wanted to see in situations and samples that represented the 3 different risk groups versus pancreatic cancer in a best possible way. Then we took it further in the autumn of 2019 where we did then bring the commercial candidate of the test, and we brought in samples from many hospitals and represent the results that confirmed to the optimization results. And that opened the path now for the final 2 steps, as you see here, verification study, independent samples and running it with known sick or healthy. We'll use that for the documentation for clear CAP and for CE marking. And then as a next step, after that, into the validation study, same thing: independent samples again and blind samples. And that leads directly to sales start in U.S. after the clear CAP. So that's the way forward.

Talking a little bit more about the first study, the optimization study and the other one as well, of course. The task is not really to distinguish between pancreatic cancer and healthy only, it's to find pancreatic cancer versus people who have symptoms but it's caused by something else, such as inflammation in the pancreas, pancreatitis, liver diseases, bile ducts, gall stone and so forth. That's the real clinical situation. You have a flow of patients that have symptoms that may be pancreatic cancer. And in most cases, they are not healthy, they have something else.

So many reports in the market and academics also show the difference between pancreatic cancer and healthy. That's all good, but the real clinical situation is to show it versus symptomatic ones. And that is the ones what we did in the first -- in optimization study, as you see on this slide, where we've had excellent results in -- with sample representing all these risk groups, both symptomatic, healthy and diabetics. And we did this in all stages in these results you see on this page, stage I, II, III and IV of pancreatic cancer versus the symptomatic risk groups were as healthy as well.

When it comes to the treatable ones, stage I and II, this is important, very, very important. Our technology and our results show that we do find stage I and II equally go to stage III and IV. And it's this stage I and II that are treatable. So that's a unique property. You can see other technologies that have good results in stage IV but not so good in stage I and II, and then it doesn't solve the situation. Ours does. It has the same great results in stage I and II.

So the last now, the Commercial Test Model study was completed according to plan, reported in the press release just before Christmas 2019. It did confirm the results on optimization started with high accuracies for diagnosing pancreatic cancer in early stage versus all controls. It was a large study, 1,100 samples. Really important is that we brought in samples from 8 different hospitals across U.S. and various parts of Europe, Spain, U.K., Sweden and several hospitals in U.S. We did this to show robustness. This is very important. Of course, in the real situation, of course, you get samples from different hospitals. And although there are standard operating procedures on how to collect the samples, there will inevitably be variations between the different hospitals.

So here, we could really show that -- in this study that the commercial version of IMMray PanCan-d is very robust even though the samples come from different hospitals across the spectrum and also with different people with different genetic background and so forth. So that's a very strong evidence that the IMMray PanCan-d very likely will perform great in the true commercial situation. And for the investors, of course, this is a significant risk minimization technically.

Right now, the patenting is ongoing based on the results of the Commercial Test Model study, and that is -- has strong opportunities for very strong patents and that it will take a little while. And after that, we will be able to present even more data, detailed data for the scientific community and so forth. But right now, it's crucial to secure the patents that will protect us for 20 years from sales start basically building on our huge patent portfolio in pancreas cancer, of course, in general.

All right. So let's move on to the commercialization and the sales start in Q3 2020. This is a work that has been ongoing really for the last 4, 5 years, but now we're of course accelerating the activities, and I will touch upon on some aspects of this right now.

First of all, you know that we have been building the world's largest Key Opinion Leader network for the last 5 years. And today, we can surely say that we, in pancreas cancer, have the world's best and largest Key Opinion Leader network for this particular area. The importance of key opinions cannot be underestimated. First of all, they give extremely valuable input to the detailed clinical use of the product, how it should be defined, how it should be tested, how it should work. Secondly, they are the first customers. They also influence all other clinicians very strongly to take the decisions to work and to use the test. They are advisers to the reimbursement or insurance or payer side, and that is of course crucial to get their endorsement there. In this case, they're also heavily involved in the patient organization. So key opinions are truly important. And we have on our home page, the following slide, where it shows that we have the world's best renowned centers and a very strong presence in the U.S., our target priority market number one, as well as in key countries in Europe in place.

Secondly, what we announced shortly after Christmas is that we strengthened the management now given that we are moving into the sales situation. We added, as you see on the upper-left corner here, Mike Pettigrew as Senior Vice President, Sales, North America. This is extremely experienced and strong addition to the management in the commercial sense. Mike previously was the head of the whole North and South American sales force for Thermo Fisher Scientific and has a 30-year experience in bringing innovative product in life science to market in U.S. and North America. So we're very happy to be able to attract such an experienced and talented leader, who has now devised our sales strategy together with our great market access team located in Marlborough outside Boston, who has done a fantastic job of setting up the scene for the sales force that's now being built by Mike.

Taking a step further what we are doing in more detail in our commercialization strategy, and this doesn't go only for U.S., of course, it goes for the key markets to Europe as well, but I use U.S. as an example here. We have -- our sales force will be focused on the gastro centers in the prioritized countries. And the reason for that is that they are the ones that run the current screening of the familiar group. And of course, we want them to use our test there. They also have an immediate need of the test for differential use, as we discussed previously in the target groups.

We have -- our market access teams have mapped these target centers down to the individual level, who should be contacted, who should be worked upon by the sales force and market teams. And we have also, together with the gastro centers, mapped the exact patient flow where the test will be used in their current flow of patients. Very well prepared.

On top of that, marketing and communication activities are planned for all relevant pancreatic cancer events and conferences 2020 and onwards. We have -- are preparing the online channels for awareness and for the access to the test moving forward and information about test. And we have a program running since a few years and now being expanded where we work with the patient organizations in various aspects of creating awareness and access for the relevant patient groups to the test.

On top of that, it's really important to work on the logistics from test requisition, how to order the test to providing a test result to the clinician. Many steps are involved there. And the convenience and the easiness of the logistics is really, really important for penetration in the various markets. There has been excellent work done there in all our geographies moving forward. And it's ready to go.

A few examples of this. Our collaborations with the patient organization is deep in U.S. The 2 largest patient organization organized something called walks. These are gatherings in all the major cities, basically every week, the whole year round. And this is often or very much visited by family and hereditary individuals and the clinicians and -- from these cities. Of course, that's a key target group for us.

Our team met, in 2018, 24,000 participants in these walks, huge compared to the European situation. 2019 was expanded too, and we met 37,500 participants in about 30 meetings. 2020 now, the team has expanded this together with the patient organizations to 60 meetings, meaning 100% up when it comes to number of meetings. And these meetings can be anything from hundreds of people up to, I think, the record was 6,000 people in 1 meeting. So it's a fantastic tool for awareness and making people aware that our target group in the familiar and heritage group are aware of the test that's now getting available this year. Strong work there.

When it comes to logistics, of course, I talked about here, it's really, really important to make it easy for the commission to order and make sure that supporting material that supports that decision is tailored for the -- for a smooth and easy way to set the name under the request test requisition and send it in digitally or even physically, let's say, to our customer support that will then handle the order and initiate the tests and make sure that even the blood draw is done in a very efficient way. We have a competitive edge there with the system we built up and making it extremely convenient for the patients to draw the blood. It is not that easy, particularly not in the U.S., all the time.

So this will be a competitive advantage. And that system has been built up over the last year here, and we're actually using it in our prospective studies already. This means that the sample will arrive from the patient's blood draw in our lab 10:30 the morning after using collaborators when it comes to phlebotomy and also to, of course, transportation.

So that logistics is all in place. It's also been prepared for Europe, but in different ways per country that best match the situation per geography. So the team is ready. The commercialization is accelerating towards sales start, and we are well prepared.

Finally, a few words about the pipeline. Although the focus is, of course, now to bring the pancreas cancer test to market, we are progressing well on the lung cancer and rheumatoid arthritis. I just want to illustrate that we are in an early stage. You can see in this picture here, Slide 23. And we are now having the samples we need here and the lab work, and the testing will proceed as we have communicated for lung cancer. For example, we will have the results in Q3 -- Q2, sorry, in this case.

So summarizing the situation the 2019 and the path forward. We are focusing on sales start Q3 2020, being first to market with a solution for pancreatic cancer detection with very good data. Lots of hard work in between now and then, but we will make it. We are building this on the excellent results from the optimization, covering all target tools and the equally excellent results in the Commercial Test Model study. These 2 of course has been the 2 large risk minimizations from a technical point of view. We are at the same time running the largest prospective studies, and this is we do for clinical utility, which is the data we need for reimbursement discussions, not to start sales. And we have the world's largest Key Opinion Leader network supporting all these efforts. Fantastic situation and very, very encouraging moving forward.

Pipeline. Of course, as we bring the pancreas cancer to market and show that we sell it as well, the value of the pipeline will increase, although it's in earlier stage.

So with that, I will finish here and open up for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We do have a question coming through from the line of Lars Hevreng calling from Danske.

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [2]

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Yes. Can I just ask, when you discussed your license providers, that's the order the test there, when it's commercially available, how is it going with the buildup of the amount of how many people you have for targeted license providers at the time of launch late this year?

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Mats Grahn, Immunovia AB (publ) - CEO [3]

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Well, remember, what we are building up, first of all, is the patients in the familiar group that we meet that, for example, at the walks that actually contact us directly. So in that sense, we are building up waiting lists of thousands of people at this stage and that -- and at some stage, want to test order. They of course have to order it through their GP. I mean, that's what we have made very simple by developing the test requisitions and so forth moving forward. That's one of the paths.

Now the path is, of course, the direct sales to gastro centers, which will be the focus of the sales force where we have mapped up all the relevant gastro centers we want to target with the sales force as soon as they start working.

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [4]

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Okay. And in terms of waiting list, what's your estimate today and when the test will be commercially available? How many people, test do you have that you could convert into, what I understand, that ordering and testing?

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Mats Grahn, Immunovia AB (publ) - CEO [5]

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Yes. Well, depends on which time line. But there will be several hundreds already in the first month there, absolutely. But the exact numbers over the first years, we'll come back to you in our forecast for the years and so forth. But there is a -- there's nothing else out there for them as well, so this -- we have an extremely strong inflow of interest.

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [6]

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Okay. And what's your -- ahead of the interim readouts, as you said, towards the end of this year, what's your working assumption today in terms of how many tests need to be formed to find 1 patient in a treatable stage of, say, stage I and II?

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Mats Grahn, Immunovia AB (publ) - CEO [7]

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Yes. Right. If you look upon the new onset diabetics, for example, close to 1% of the new onset diabetics have -- will get pancreatic cancer within 3 years. So in that sense, if you test all new onset diabetics in that group, over 50, there will be about 1% that actually have cancer, for example. It's higher in the familiar group over the years, but that's -- yes.

And of course, in the flow of patients, in the differential, it depends where you're looking to use it. In the gastro centers, it's very high because -- but they are most in earlier stage -- in later stage. And when they are at that stage, in the primary care, you have to use different selection criterias in primary to make it to about 2% to 3% having cancer.

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [8]

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Okay. And in terms of the collaboration with the pharma, if a pharma company would use your product as a screening tool in pancreatic cancer study, would that be dependent on any regulatory approvals? Or is that something that you do independent of that?

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Mats Grahn, Immunovia AB (publ) - CEO [9]

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It's unlikely that they would like to do screening or it would be nice, of course. But they -- normally pharma's interest is different. Pharma wants to understand whether the patient is a responder or nonresponder to the drug. That's a different clinical question, and that will be a different test. They are, of course, interested in developing such tests. So in pancreas cancer, of course, it's the same thing as using our test if you want to purely do early detection as we do. Or did I misunderstand your question maybe, Lars?

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [10]

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No. That's exactly what I meant. I think -- I mean that's the screening tool, that's something different. Now that's not something you're planning, so to say, to offer it -- in your...

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Mats Grahn, Immunovia AB (publ) - CEO [11]

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Well, if pharma companies are interested in that application, we are open for collaboration. But the business model in terms of on that other field, which is responder/nonresponder, that's not early detection. That's a different clinical question, which is the interest of pharma. But the business model there built up by the OpCo and others in history is that you actually -- the pharmas pay the diagnostic companies to do such studies and develop the product for them in finding patients that are more likely to respond to their drug than not. That's an interesting market as well. But for a diagnostic company, it's an add-on or at least, for us, it's an add-on opportunity, not the core strategy. The core strategy is early detection for us.

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [12]

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When you, in the report, highlight that you're going to launch first in the U.S. and later stage in Europe, is that then the difference to before where you had mentioned that...

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Mats Grahn, Immunovia AB (publ) - CEO [13]

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No. It's just a slight difference because it takes -- it goes a little bit faster with it after the validation studies. We do of course a validation study now in lab in U.S. for the U.S. market and in our lab in -- here in Lund for the European market. There's a little bit more work with the CE marking. We are talking about the number of months than the accreditation in clear CAP. So it's just that difference.

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Lars Hevreng, Danske Bank Markets Equity Research - Research Analyst [14]

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Okay. All right. And just finally from my -- the -- when you talk about confirmatory market expansion studies post or in parallel to this, can you say anything about the ambition there?

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Mats Grahn, Immunovia AB (publ) - CEO [15]

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Yes. Yes. Sure. It is like this. When you have a test on the market, say, U.S., and you have got established in certain countries in Europe or other markets as well. When you enter a new market, a new big country in Europe, for example, you often have to do a smaller study with the local Key Opinion Leaders with the, say, French patients, so if you take that as an example, to get penetration.

If you want to go into other markets outside Europe like Asia, China or Japan or Korea or Taiwan and so forth, you have to do a confirmatory study showing that it works on that population group. It's not really scientifically -- maybe the crucial thing is more acceptance of the local Key Opinion Leaders or so forth. That's something you do as the market activity are ongoing when you expand your geographical markets.

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Operator [16]

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We have...

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Julie Silber, Immunovia AB (publ) - Director of IR [17]

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Good morning. This...

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Operator [18]

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Apologies. Please go ahead, Julie.

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Julie Silber, Immunovia AB (publ) - Director of IR [19]

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No. I was going to interject to some of the questions that we're getting via the web interface that we have introduced to this conference call, and it seems like a good place to sort of talk about this. We have a handful of questions about the verification and validation process. So, Mats, I'm going to ask you some of the questions that we were getting online.

Can you explain the steps getting towards the clear CAP Accreditation? Does this occur simultaneously with the last 2 milestones of verification and validation?

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Mats Grahn, Immunovia AB (publ) - CEO [20]

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Yes. Okay. It's basically the same steps, as you say there. We do a verification study now where we run the known samples. And then we do the validation, both with U.S. samples in the U.S. lab, and that goes into the clear CAP Accreditation. We do the validation with European samples. Where more samples, we can also use the American for the CE marking actually here in Sweden. So that goes on in parallel. So the validation is done in 2 places, so to say, but it's simultaneous.

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Julie Silber, Immunovia AB (publ) - Director of IR [21]

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Great. So the next question is, what's the difference between clear CAP and FDA?

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Mats Grahn, Immunovia AB (publ) - CEO [22]

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Okay. Well, U.S. and elsewhere as well -- but the U.S., when -- you can sell diagnostic tests in 2 different ways. One is that you make a kit, a physical kit to say that you sell to other laboratories and they perform the test, all right? You can sell it to any lab then. Then you have to get an FDA clearance according to the diagnostic part which has nothing to do with the pharma, by the way, some people mix up.

But -- so that's what you have do. If you want to sell a kit to other laboratories and spread the test that way, then you have to have an FDA clearance.

Okay. If you, on the other hand, go to reference lab where you sell the service of receiving a sample and delivering the test result, that model is not regulated by FDA in U.S. It's regulated by the clear CAP. So there, you have to show -- follow a lot of guidelines, rules and show your standard operating procedures, your data, your results, your validation study and so forth. And that goes into the filing for that, and you get accredited. The laboratory gets accredited to deliver -- receive samples and deliver the answer. So there are simply 2 different organizations, to say, that regulated 2 different ways to market in U.S., which is different from Europe where you have a CE mark and then you're allowed to sell either way.

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Julie Silber, Immunovia AB (publ) - Director of IR [23]

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Great. So the next question along the same line is, do we have the samples yet for verification and validation? Can we talk about that? Are we on track?

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Mats Grahn, Immunovia AB (publ) - CEO [24]

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We are on track, absolutely. And we will, as we have announced and which I show in this presentation as well, have the results from the verification in quarter 2 and in Q3 for the validation. And then in U.S., the accreditation follows immediately on the results of the validation. And it takes a few months extra in -- for the CE marking after the validation.

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Julie Silber, Immunovia AB (publ) - Director of IR [25]

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So then a follow-up question to that is, so there's no problems with obtaining the proper blood sample that comes with the (inaudible)?

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Mats Grahn, Immunovia AB (publ) - CEO [26]

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No. We have -- we're in position. We're probably one of very few players in the world who can do this because we have such a huge and very supportive key opinion network. So that's not an issue.

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Julie Silber, Immunovia AB (publ) - Director of IR [27]

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The next question actually comes and asks about our pipeline projects. One is, do we have the ethical approval yet from Leiden University to start the study with rheumatoid arthritis?

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Mats Grahn, Immunovia AB (publ) - CEO [28]

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Yes.

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Julie Silber, Immunovia AB (publ) - Director of IR [29]

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And then the last question here online is, do we have a sales budget and can we talk about that?

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Mats Grahn, Immunovia AB (publ) - CEO [30]

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We have given guidance that we aim to achieve SEK 250 million in 2022 run rate, and that we remains firm with. We will, as we start selling, of course, do more detailed forecasts moving forward. But it's a bit too early for that, but please remain confident that our previous guidance is what we stand by.

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Julie Silber, Immunovia AB (publ) - Director of IR [31]

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One more question just came in, again, on our pipeline projects. Why do we not accelerate the work on lung cancer? For example, it is a bigger market than pancreatic cancer. So why our effort is not growing in that aspect?

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Mats Grahn, Immunovia AB (publ) - CEO [32]

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Well, we have a fantastic opportunity to dominate the pancreas cancer market where it's nothing there. It's an imminent need. We have the world's best test. We are very close to finalizing the long path towards accreditation. We need to focus to do that. It's crucial for a company with fantastic blood -- bleeding-edge technology to show that you can take one product to market. And this market is also extremely open for new products. So the focus is strong on that one. That's the main reason.

Then, of course, the pipeline products benefit from all we build up during the pancreas cancer project. It's not only the product in that case, it's the whole infrastructure, the quality systems, the production, the R&D work, the labs and so forth. That's one reason.

The third reason is that the key one -- key aspect of succeeding, as we talked a lot about, is to build a Key Opinion Leader network. And that is something that in the early stages takes a little bit longer because you have less data to show to the other key opinions that's -- you want to join. You want the world's best. And they are, of course, attractive also for other players, and they have to make a choice. Who do you work with? They can't work with everybody. So that takes -- which it did in the lung -- pancreas cancer case as well in the early days. Now everybody wants to work with us. That's the different thing, of course, as we show in results.

So the work is maybe not shown, visible that much, but building the Key Opinion Leader market is the hardest thing in the beginning, and this is the crucial thing, and that's what we're doing in the pipeline projects. So you will see more activities in these ones that we can talk about later on, but the company's focus has to be on pancreas cancer right now.

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Julie Silber, Immunovia AB (publ) - Director of IR [33]

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One last question from the online crew is, what are you thinking about the price for the test?

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Mats Grahn, Immunovia AB (publ) - CEO [34]

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Yes. We have done a lot of work on that early on. And our target is an average USD 600 per test. We have been validating that in different ways in discussions with the payer side. We have done surveys among self-pay people and so forth, hundreds and hundreds of them. So the -- we are confident that, that will be our target moving forward as well.

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Julie Silber, Immunovia AB (publ) - Director of IR [35]

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I'm going to turn it over to you, Courtney, to see if we have any calls coming in with questions.

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Operator [36]

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So we currently have no callers in the queue. (Operator Instructions) We have no callers coming through, so I shall turn the call back over to yourself, Mats, for any closing remarks.

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Mats Grahn, Immunovia AB (publ) - CEO [37]

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All right. Thank you for staying online. It's been great to present this today. I'm very proud of the results we achieved. I'm very excited about going to market, starting sales, being first to market and really excited actually to provide something that the affected people of pancreas cancer are waiting for, have been -- are needing and making an impact for the ones that will have an increased chance of survival based on this. That's really a driving force for the whole team here.

So excellent results from the studies we've done. I don't think anybody in the world is close to what we have achieved and the data we have. We have the world's largest prospective studies ongoing and the Key Opinion Leader network support and the patient organization support. This is truly an exciting 2020 for Immunovia. So I look forward to further describe what we are doing and definitely looking forward to the sales start in Q3. Thank you.

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Operator [38]

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Thank you for joining today's call. You may now disconnect your handsets.