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

Hello, and welcome to Immunovia COVID-19 update #3. My name is Jose, and I will be your coordinator for today's event. Please note that this conference is being recorded. [Operator Instructions] I will now hand you over to your host, Mats Grahn, CEO, to begin today's conference. Thank you.

Thank you. And good afternoon or good morning, depending from where you're calling in from. Welcome to this third update regarding COVID-19 impact on Immunovia's activities. This is of course a changing environment for everyone in the world today, and we want to do a regular update to keep you informed about the status. Today's focus will be mainly on the steps to launch given the Marlborough and Massachusetts shut down there. And we will also focus on the launch preparations where we are forcefully going forward with digital methods in our launch program. So let me then -- hopefully you have the slides in front of you while we do this. And as we said, the agenda is the response to the pandemic, remaining steps to launch, focus on the digital launch preparation activities that we talked about before. We'll go more in detail today. Mention the prospective studies. And then finish with the questions and answers. So let's begin with our response to the COVID-19 pandemic. As the, previously talked about in the calls and press releases before, we continue of course with the work-from-home policies in our company. We follow guidelines and orders from the authorities. In Sweden, the R&D labs, the clinical lab and the production facilities in Lund, South Sweden are fully operational. We have had no cases of COVID-19 yet, although we are of course careful with people with normal symptoms, and that means little bit of changing of tasks and so forth, but it's still functioning very well in that area. The U.S. clinical lab, very well prepared with detailed plans. They are of course working at home. However, the last time we talked about this as a major risk, that the Massachusetts has a statewide shot down, that one has lately been extended to May 18th. And we will talk about that during this call today. When it comes to the suppliers, we have stocked reagents, consumables, chemicals. And we have all instrumentation in place. This is still okay. We have a good stock of supplies. And also there hasn't been any disturbances at all on that side. So that is in good shape. Regarding the collaborators, the clinical collaborators, the large hospitals around the world and our key opinion leaders there that are important for us in terms of collecting samples and running their prospective studies and so forth, of course this is affected since many sites have stopped clinical trials in general, given the regulations and guidelines they are under, and focusing on handling the COVID-19 patients. So this as before. However, we see some light in the tunnels here. Some sites, particularly in Europe, is getting back to collection and also are accessible for our planning going forward. And we anticipate that that would be followed in U.S. shortly as well. So there is some good signs in this area, definitely. We are then coming to the main topic of the day, remaining steps to launch. The status and where we are in the process is, as you know, we are right now working on the verification study with the lock signature and algorithms and known samples. And as before, all samples are collected, and we are in time. And this is all work that is doing -- done in the Lund facilities, in the R&D facilities here in South Sweden. The validation study on the next step after that to follow. And that needs to be run in Marlborough for the CLIA/CAP, and also in parallel in Lund for the CIVD moving forward. So we are clear on where things are done. And these 2 activates then are because of the closure in Marlborough affected slightly in timelines, which we will look into it right now. And the situation in our Marlborough lab, as we talked about already at the last call is that very well prepared with plans, detailed activities and so forth, leading up to the accreditation and sales start. And first, there was an announcement of a statewide shut down from March 25th to April 7th. And then that was extended to the beginning of May. And now there is another decision by the governor to extend this further to May 18th, including stay-home guidelines and nonessential to COVID-19 and businesses should be closed and also the facilities closed. And now this will impact the target date. There is over 2 months of time here that we haven't been able to access our lab. And therefore we are forced to move the sales start target to Q4, slight forward move in the plans there. To make it extremely clear, we added this slide here, that the extension of this order from the governor in Massachusetts has forced us then to revise the timeline and the sales start. We also factored in the possibility of a further extension from the governor to the beginning of June here. That may happen or may not happen, but we feel that it's prudent to include such precaution. And that's why we look upon finishing the validation study for the U.S. launch in Q4. What we do as well is to, of course, constantly try to mitigate all activities that will happen, which means that one activity we do is to move activities and accountabilities between the sites where possible. And therefore the workload changes on the sites also in Sweden. So that means that we do move into, slightly into Q3 for the verification finish. That's the connection there. But the verification study is done in Lund completely. There is all the samples, there is full speed ahead on that one. But the total plan needs to be optimized for the launch date, and that's how we utilize our resources over the globe. And that is further in details on this next slide here, the 2 important last steps, verification study, as we just mentioned. It was to remind you that we have all the samples in-house. We had a very successful collection that gave extra samples that we can allocate to the validation study. The validation studies are then done in 2 parts, one in U.S. for the CLIA/CAP has to be done in the lab there. And the same for CIVD in Lund. We have most samples in-house, particularly for the U.S. collection. We need to secure the transfer of some already collected samples that are still at hospital sites. And that is something we are confident that we can do before they are needed at the lab there. They also have the mitigation that the exact samples from the verification can be shipped to the relevant place where we need them for time reasons. So to repeat that, we have focused always on optimizing the time to launch, that includes, among many things, activities balanced between the different resources and tasks we have both in Europe and U.S. And that's why we have a slight defection also on the verification study. But it is running as planned forward. And we have all what we need to complete that one. So to further reiterate, there are a subset of studies. It's not only the validation study and verification, but these are the 2 main activities. There are of course other preparations and transfers of information and knowledge, and preparation of the laboratories and so forth that are not time-crazy but are done in both labs. So the full picture really, when you run this product list you have to look into all activities and move them for optimal performance of the complete picture. And the subsets, let's say, of the studies are required to be done in the laboratory where the accreditation is going to happen. So that's the point of this slide, to reiterate that. Let me now move into the commercial launch preparation activities. We have previously mentioned that the effects of the COVID-19 situation is that clinical conferences and patient organizations meeting as samples are very important to -- for us to create awareness to meet the decision-makers when it comes to the clinicians and so forth. These ones are canceled because they are big meetings, face-to-face. And that has led to us, as I discussed last time, to go for digital plans and activities instead, to get access to key buyers among this initially. So the main activities there has been replanned. And we moved further into a much more digital and virtual strategy for this. We also in parallel of course prepare the sales force and launch activities, and we maintain that, but have also moved much further into the digital solutions. And I wanted to go through some aspects of this to show you what we are doing in that area. So this is represented in this slide here. And I will take you through it step-by-step, box-by-box. So if we start, it's several elements that together form the IMMray PanCan-d virtual digital launch activities. So let's start on the box on the top called patient org events, patient organization events. As I mentioned, the walks or events or meetings that the patient organizations have in all major cities where we meet thousands of risk individuals that are very interested in us, and also clinicians for that towns have been crucial the last years and created a lot of interest for the company and a very close tie to the patient organizations. So it's very important. Now these ones can obviously not be held face-to-face because they gather hundreds or even thousands of people each time. So we have, as the first, digital or virtual walk agreed with the U.K.-based patient organizations to run a virtual walk in London as it was planned. And of course it become national. This is a win-win situation for the patient organizations and for Immunovia. For the patient organizations, they can use it for their activities, for example, fundraising in smart ways, at the same time as promoting the awareness of pancreas cancer in general in society. For us, of course, it gives us the opportunity to present the solution and the data and activities around the test and the launch of it. Furthermore, it gives us the advantage of these thousands of members of the patient organizations that take part in this and that we already have contacts, who are able and willing to spread these messages in their social networks, which is a key advantage. We believe this setup will be actually an efficiency enhancement when it comes to creating awareness about the launch and the products. We are also, of course, not only looking for U.K. but for the main market in U.S. to do similar setups, and are currently planning for that. So that is one of the very important building blocks of the virtual plan for launches. So that was the top box. Now move to the second box to the right of this one on the right side called virtual road tour. One concept that we always use in launches, and it's been proven to be very efficient in this business, is to have what we call previously lunch and learn, which was lunch meetings at hospitals where you get access to the decision-makers, the clinicians and so forth because they're really busy people and to get face-to-face or time with them is not easy. So a very efficient road show concept has always been to invite them for lunch at the hospitals and have a seminar with information that they are really interested in. Now we have turned this into virtual road tour instead. And that will be also including our key opinion leaders for the areas where we want to penetrate the market. The key opinion leaders will present together with Immunovia, and that these activities can then actually become even more efficient because you can't ship around key opinion leaders at any extent at all physically. However, doing it this way makes it much more efficient and makes them accessible. And we can run more of these meetings in the same time as we would be able to do if we would have to travel between the different places and so forth. So this is important to create the -- relay information at the decision-makers' place when they are willing to listen. And that creates an entry for the sales force to drive the customer relationship forward as well. So that's a key concept that we have now successfully turned into a virtual plan. Then box 3. Under this one we talked about, now it's called digital communication. Here we are now defining different channels per geography and per target customer type being risk people, primary clinicians, gastro clinicians or pancreatologists. It's very important to communicate for the online channels that are relevant for each target that they actually look upon and trust and so forth. And that is an efficient way to drive people interested in this, to the next box, which is our now extended increased investment in the website where, which is the box on the bottom. The web will of course include the major digital launch campaign, and also the hub of information for all that are very interested, want to order or want to know more about the test, or learn about the test or get access to ways to take a blood sample and so forth. So this hub, the website will be fed by all the other activities. When we run patient organization events digitally, of course we can record them and we can put them here, meaning that they get accessible for across-the-world virtual road tour, could potentially be presentations can be put as well and so forth. So that ties together. Then the next box, which is on the left side, called digital sales tools. That's a more internal box in the sense that you have to have great sales tools for the sales force. You also have to train the sales force when they come on board in the company as we build up the sales force step-by-step. This has been turned into and will be turned into a completely digital toolbox with training for the sales people, including not only training on the product, on the positioning of the product, on where to go and things like that, but also include training from professional virtual selling skills and tools for that. And of course, the traditional collaterals such as brochures, posters, videos, podcasts and so forth. So that's a toolbox for the sales force that we now take much further when it comes to digital use than traditionally. And then finally, the top left box called live stream digital launch event. That's the on-the-launch-day event which will be a major presentation with key opinion leader speakers, key speakers from Immunovia, and driven also hopefully in sync with patient organizations and other that creates a lot of awareness around the product. So this is a little bit more of a detail of a very big package now put together and worked really hard on from our commercial organization. And we believe this is a very good package in -- and also mitigates any potential risk that the COVID-19 situation is prolonged where it's not possible to physically meet the customers before the launch, so to say. So this we are happy to announce and to fill you in going forward with different activities that take place in real life. Okay. That was one of the main messages today. When it comes to the prospective studies, that has not changed since last time, just repeat that the PanFAM-1 is the ones that are affected, because the people that come twice a year to leave blood and once a year to take care an imaging have difficulties of course to travel to the hospital, also that the hospitals are postponing this because of the COVID-19. So there will be, so to say, a waiting period until they start up again. Although some hospitals have actually started up already in Europe. And so there is some light in the tunnel there. PanDIA has continued very well the collection of samples in South Sweden. One reason being that the South is not affected that hard at all of COVID yet, or maybe will not be at all. We will see. But there is already enough samples collected for the interim study that we are planning. We are also confident that the intervention phase of PanSYM, which is planned for early 2021, to show clinical utility for differential diagnosis is possible to get in place by that time. So no change there really except that there are some openings in the first hospitals that have started to enroll patients and take blood samples and work with PanSYM again. So this is the summary of the three ones, moving on. And we will of course continue to update on this. So to summarize, well, we have of course, like everybody in the world, been affected by the COVID-19 situations. We have day-by-day taken lots of actions to mitigate and it's been successfully to date. We had now to update the timeline finally a few weeks forward because of the prolonged shutdown in Massachusetts. But be reassured, we remain completely focused on the launch of IMMray PanCan-d. And we will be first to market with a very accurate test for early detection of pancreas cancer. We will monitor and adjust to any further unforeseen circumstances of course. But the main message, we will be first to market for early detection of pancreas cancer to address this huge market opportunity, in total over USD 4 billion for the European and U.S. markets. So we remain confident. We are extremely enthusiastic about the prospects of the company going forward. And I hope you will continue to stay with us on that journey. And with that I would like to finish and open up for questions.

[Operator Instructions] We have no questions coming through at the moment. [Operator Instructions] We have no questions on the line at the moment.

Okay. Do we have something on the chat maybe?

Yes. This is Julie Silber, Director of Investor Relations. There's a couple of questions here on the web portal that I can share. The first one is, "Can you give us a little bit more information on the work that's being done in Lund versus what was supposed to be done in Lund?" I guess basically the question is saying what's being done in Lund now that has been shifted from Massachusetts.

Okay. Well, first of all, the focus in Lund is of course the verification study now. And in Marlborough, they work from home, doing some digital work, of course, preparing plans. And also, sometimes time can help out on results from this digital work in the analysis part and so forth. But it's difficult to do anything that's related to the lab, where it's actually impossible when you can't get in there. However, there are activities apart from the verification study that was done that needs to be done there as well. And the 2 organizations then try to help each other as much as possible, moving over activities. And that will help when the compressed timeline in Marlborough, when they come back, so that parts of that may be done or supported from here, which means that the workload increases on this side as well. So what we do, as I said before, is that we try to balance all activities in the most optimal way to meet the shortest possible time to market. That's the key thing. But the main 2 big activities, which is the verification study, that's done entirely in Lund. And the validation study needs to be done partly in both places. So that can't be changed. There are also some mandatory preparations for the accreditation in U.S. of course that cannot be moved or changed or so forth. But there are all other activities. We constantly discuss who can do what and so forth and the place where it in total gives the best possible outcome.

Great. Thank you, Mats. I have 1 more question from the web portal. And I think that there's a calling question at this point. But let me go ahead with the web question and then I'll turn it back to Jose. The question is, "Do you see any timeline differences for the EU launch? Does this COVID situation affect the potential target time for the launch in Europe?

It will still be slightly, as planned before, slightly behind, a couple of months behind the U.S. launch. But we don't see any particular difference in time between that launch and the other one. Of course we need to get some other samples from Europe in, during the Q3 and so forth. That's the possibility. But we have good communication with the ones who supply that, and they are still able to do that currently. So I don't see any delays there at the moment at all.

Great. Okay. There's a few more questions on the web portal. "Does the company have sufficient capital to support operations toward launch, if COVID-19 persists throughout the year?"

Yes.

That's a very quick answer. Next question is, "What is the timeline of the patent application? And when will the commercial test model be presented?"

Yes. We are working very hard on that one. There's been a lot of extra technical investigations that needs to begin for the patent, that's been done. Then there is the preparation of future publications. That is text that is also needed for the patent application and so forth. But we are still -- have a little bit of work to do on that one. But we hope to be ready fairly soon at least towards the end of this quarter maybe or early Q3. But during Q2 we hope to finalize it.

Great. Thank you. The next question is, "Is there a time limit for the samples that are, have been collected?" I'm assuming this means sort of an expiration date on the samples that you've collected thus far?

Okay. No. All the samples that we have collected for the verification and validation study, and also for the CTMS before, and the optimization, that they are provided and are within the guidelines that we put forward on being fresh. So that is really fresh samples. That's unique for us to have access to that actually, particularly the symptomatic control samples that are from patients that have symptoms that could have been -- could have been pancreas cancer, but it's different other diseases or conditions. But also for the pancreas cancer cases they are also fresh, less than a few years old as well. So there is a unique advantage that we have. And that remains definitely for all our studies now. I don't think anybody else could do that at the moment at all.

Great. Thanks. There is another question, and I'm not exactly sure what it means, but I'm assuming it means something to the effect that Massachusetts is planning a 4-phased opening. Do we know when the Massachusetts lab will be opened during that planned process?

Phases?

Yes.

It's a bit -- yes, it's not 100% easy to know, because there are different changes in the way they classify essential business. And we are of course communicating as much as possible with authority about this. And it's very important to be classified as essential as soon as possible, to open up as early as possible in that one. And we are hopeful that we will be able to get going, at least within the timeframe we now have set aside here before early June. So we are pretty confident that that will be possible. Given current discussions, you never know what can happen, maybe if the disease -- I hope they have passed their peak, it looks like that, even though it's still high in general with COVID-19 in Massachusetts. But if they've passed the peak, I assume that this will enable the possibility to get into the lab again.

Great, thanks. That seems to be all the questions we have so far on the web portal.

Okay.

Are there any online on the live call?

We currently have no questions here. [Operator Instructions] We have no current questions at the moment.

All right. Thank you then for listening. We will keep a very transparent way forward on the COVID-19 and our path towards the launch. We are extremely encouraged about the possibilities to be the first on the market for extremely needed tests for a very, very large market. And we are very confident. And we have the resources and people ready to do this for us. So thanks for listening. And I'll be happy to talk to you again, going forward.

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