Immunovia AB (publ) (IMMVF) Q4 2025 Earnings Call Transcript

2026-02-24 14:57:53 ET

Immunovia AB (publ) (IMMVF) Q4 2025 Earnings Call February 24, 2026 9:00 AM EST

Company Participants

Jeff Borcherding - Global Chief Executive Officer & President

Conference Call Participants

Niklas Elmhammer - Carlsquare AB, Research Division

Presentation

Jeff Borcherding
Global Chief Executive Officer & President ...

Good morning, everyone. This is Jeff Borcherding. Thank you very much for joining the call this morning. We are excited to speak with you about the fourth quarter for 2025 and what lies ahead as we continue to build on the success of the PancreaSure launch and prepare for securing reimbursement and continuing to drive the success of this product as we move to achieve our mission of changing the way we detect cancer in pancreatic cancer and making a significant difference in people's lives.

For our agenda today, we will do a brief review of 2025. We'll go into more detail about the PancreaSure commercial results in the fourth quarter of the year. We'll then talk about our progress towards reimbursement with a special focus on the clinical studies that lie ahead as well as the steps that we've already accomplished.

And then finally, I'll turn it over to my colleague, Adam Backstrom, to discuss the Q4 financial results and our cash position. In 2025, more than 2 years of development and clinical research culminated in the commercial launch of PancreaSure. And as we look back on 2025, there are a number of things that we're proud of as a company, but here are some of the highlights.

Certainly, at the top of the list has to be the commercial launch of the PancreaSure test. A couple of years ago, we made the difficult decision to remove our IMMray PanCan-d test from the market and bring to the market a better test that could detect cancers earlier, could do it with a greater level of sensitivity and specificity, particularly for those people who don't secrete CA19-9.

We also wanted to make sure that we had a much more robust set of clinical data supporting the PancreaSure test. And I think we clearly saw that in 2025 when you look at the scientific dissemination that happened about the PancreaSure test. We had 5 clinical studies that were published in scientific journals. The CLARITI study was named the best of DDW at the Digestive Disease Week Conference, which is the world's largest gastroenterology conference. At these scientific meetings that we attended last year, our data was selected for prestigious podium presentations at 5 of those meetings.

And in order to continue to fund that research in order to fund the launch of the test, we were also pleased to raise over SEK 140 million to support that launch, to support those clinical studies and to take us to the next critical milestones in our launch. We also received strong support in addition to that support from the scientific community, we received strong support from multiple advocacy groups within the pancreatic cancer space.

And then as we'll talk about a little bit later, we were able to secure a lucrative reimbursement rate of USD 897 from the Centers for Medicare and Medicaid Services. And we'll talk about why that's so important in just a moment.

But first, let's dive deeper into the PancreaSure commercial results. Before we do that, I would just like to remind everyone what is our strategy for launching the test. So here, you see the 4 key pillars of that strategy. Perhaps most important is the idea of starting at the top. We want to build advocacy in use among the key opinion leaders, the experts in this field who practice at the top high-risk surveillance centers in the United States. As we progress through the launch, we want to make sure that we are being disciplined financially and that means that we tie our investment to revenue.

We know that meaningful revenue will not come immediately at launch. As a result, we want to execute a very targeted, very cost-effective launch that leverages our current resources and our strengths. And then we can increase that investment in commercialization as the reimbursement grows, as we have revenue to fund that investment. We've talked previously about the fact that finding a commercialization partner is going to be a critical aspect of launching and commercializing the PancreaSure test.

Our goal is to demonstrate to a commercial partner that we have enthusiasm in the market. This is a test that physicians want. This is a test that patients are asking for. And as we build that commercial revenue, we want to make sure that we're showing them how it is that we will get reimbursement for the test in order to secure a really strong commercial partner.

And then finally, we want to run very efficient and very lean in order to preserve our cash, make sure that we are very operationally efficient and that we automate as much as possible and that we're very scalable so that as our volumes increase, our costs don't increase along with them.

Focusing in on the first phase of the launch, I mentioned that our goal here is really about driving targeted advocacy. This phase of the launch started with the launch of the test in September of 2025 and it will continue through the second quarter of 2026. During this targeted advocacy phase, we are really focused on the key opinion leaders in top high-risk surveillance centers in the United States where people are being screened for pancreatic cancer.

During the early stages of the launch, we did not have a separate sales team. All of the results that you saw in September as well as the results in Q4 are the result of selling by members of our existing management team.

As we move into 2026, I'm excited to share that we have now hired 3 strategic account managers who will be covering the country and bolstering our sales efforts.

The last thing that I want to touch on as we think about this first phase of the launch is what are the metrics that we are saying are really critical. And most importantly, it is the number of high-risk surveillance centers that are ordering PancreaSure. Why is that the right metric? Well, for a few reasons. Number one, because it's all about driving expert advocacy at these centers. This is where a lot of high-risk surveillance is taking place. These are the experts that are relied upon by physicians who are doing high-risk surveillance. We want to have a strong presence there, and we want those physicians to be using the test.

Second, this focus allows us to be consistent with our goal of being very focused on the most important targets that we have commercially so that we can limit our investment and limit our spending.

And then finally, you see that a secondary metric is the number of orders. We want to make sure that these centers are getting enough experience with PancreaSure and generating enough usage of the test that they really get a sense for how the test is used. That volume number becomes important, especially as we get to the second quarter of 2026.

So as we're in the early stages of this targeted advocacy phase as we close out 2025, we're really very focused on the number of centers that are agreeing to implement the test and those centers that are ordering. This stage will set the scene for what we do later in 2026, where we'll have more focus on building volume as we begin to ramp up volume in anticipation of the revenue phase and the revenue phase really begins in 2027. It's not to say that we won't generate some revenue before that. We will, and we'll talk about that in just a moment. But our real focus is on setting the stage for making sure that once that revenue stage starts in early 2027, that we are in a position to really maximize the revenue.

But between now and then, we're limiting our investments so that we stay disciplined and use the cash that we have very efficiently and very effectively. These are some of the centers that have agreed to use the pancreatic -- PancreaSure test and are now using it within their pancreatic cancer surveillance programs.

This quarter, you can see we added 4 new centers. And I'll just talk a little bit about each of those centers and why they wanted to use the PancreaSure test. So first is Beth Israel Deaconess Medical Center. This is a Harvard-affiliated hospital in Boston, Massachusetts, and their desire for the PancreaSure test was really driven by the fact that they very often get patients asking them about a blood test for pancreatic cancer.

As you know, today, people who are in surveillance are generally using imaging. So that might be an MRI, it might be a CT scan. It could be an endoscopic ultrasound. These imaging techniques are relatively accurate but they are very inconvenient. They're quite expensive. And so Beth-Israel's patients are very interested in a blood test, and they were excited to implement PancreaSure to address that desire from their patients.

With NYU, New York University Langone Health, their goals are a little bit different. NYU covers a very large area in New York and many of their patients have a difficult time getting to NYU facilities and locations. As a result of that, imaging-based surveillance creates gaps. There are people who just simply can't get to a facility. Maybe they don't have transportation, maybe they don't have someone that can drive them there. And so they are eager to implement the PancreaSure test and have started implementing the test in order to address those access issues.

And then finally, Prisma Health in the Southeastern part of the United States. Unlike Beth-Israel and NYU, Prisma is a private health system. It's not an academic medical center, but it is one of the leading facilities in the area. And it's important to them that they communicate to their patients that they are on the cutting edge that they are doing everything for their patients that their patients might expect from a top-tier academic medical center. So for them, a new innovation like the PancreaSure test is a really attractive addition to their high-risk surveillance program.

On the rest of the slide, you can see those organizations that previously had agreed to use the test. And I'm happy to say that adoption is going well at these centers. I mentioned in our Q4 report, UC Health at the University of Colorado has done significantly more than 100 tests at this point. And we've also got high order numbers from facilities like Northwestern Medicine and Honor Health, where they have gone through that process of figuring out how to implement the PancreaSure test and how to use it within their existing high-risk surveillance program.

As we look forward into 2026, I'm very excited about the pipeline of additional centers that we have who are looking at and evaluating the PancreaSure test. If you look at this funnel, this is essentially how we view prospects within the company as we're thinking about moving them through the process from an initial conversation to the point where that center is up and running and they're regularly using the PancreaSure test every week as part of their surveillance program.

So as you can see at the bottom, we have 6 centers that are regularly using the test. These centers have figured out how to incorporate it into their existing protocols, and they are using it extensively. We have another 6 sites where they have begun using the test but they're still figuring out exactly what their testing process will look like, how they'll use the test in conjunction with imaging and which patients within their program are the most appropriate as they start to use the test.

The stage before that is registration. And essentially, what registration means is that these 8 facilities have said, yes, we are excited about PancreaSure. We plan to implement the test and we are ready to do so. So registration is essentially just the simple process that we go through to make sure that they can access our online ordering portal that they understand the logistics of how to test.

We work with them on making sure they are clear on things like how to collect the blood, how to ship it to us. And so that registration process then very quickly leads to trial. We also have 9 late-stage prospects as of the end of the year in 2025. These are groups that have shown strong interest in the test based on initial conversations, and we are about ready to talk with them about how to implement the test and what that looks like.

And then in addition, we've got the early-stage prospects. These are people where we've had at least one sales conversation. But oftentimes, what happens is as facilities are moving through this process, as you can imagine, there are a number of different people that we need to speak with. And so in that early stage, often what we're doing is having multiple meetings with different people within the high-risk surveillance center who would be involved in using and implementing the test.

This is what the pipeline looked like as of the end of December. I'm very happy to share that these numbers have all grown meaningfully in the several weeks since the end of 2025. And I think that says good things for what our results will be in the first quarter.

As we think about the first quarter of 2026 and into the second quarter, we see 3 key drivers of commercial success in the first half of the year. Most important is the sales staffing that we've added. I mentioned earlier that up to now, all of the selling has been done by a couple of members of the management team and I.

Going forward, we will be bolstered by 3 full-time strategic account managers. These individuals bring fantastic experience from companies like Exact Sciences, which has the Cologuard test, Quest Diagnostics, Myriad Genetics and other top diagnostics companies.

Once these reps are up to speed and on board and they're very quickly ramping up, we're going to have them focused on 4 key things: one is adding new prospects to the pipeline. They'll do that through their existing network and by reaching out to new prospects. The second is moving prospects through the sales pipeline faster. We just talked about the various steps on the prior slide.

With the new account managers being on Board, I'm optimistic we can move prospects through that funnel more quickly. The third thing that they will be doing is working with the teams at our client centers to integrate PancreaSure into their existing protocols. And as they do that, that leads to their fourth focus area, which is really engaging the cross-functional team within these surveillance centers. Previously, when we were only selling through the management team of Immunovia, our capacity was limited. And what that meant is that we generally would connect primarily with the overall leader of the surveillance program, that physician expert that is driving the overall strategy and thinking for the program.

Bringing the strategic account managers on Board allows us to develop relationships throughout those teams. So relationships with people like the nurses, the genetic counselors who are having conversations with people that have those genetic risk factors. Staff people who can do things like placing orders for the test in the online portal or flagging potential patients who should be given the PancreaSure test.

So by building out their reach within the team, we can drive greater volume. So through those 4 activities, I think the sales and strategic account managers are going to make an enormous difference for us. Also driving results in the first half of 2026 will be the California state approval that we received in January as well as the New York State approval, which we hope to receive in the next several weeks.

So if you look at California, it is an incredibly rich area for pancreatic cancer surveillance. We already have 8 high-risk surveillance centers that are in our pipeline, and we look forward to sharing news in the coming weeks about those centers adopting the test.

In New York, New York is a hub of academic medical centers. We talked about one of them earlier, which is New York University, which is using our test on a pilot basis even before approval. But the approval in New York State will unlock significant potential there as well.

We have had the auditor from New York State come and inspect our lab. That inspection went very well. They had only 4 minor findings. We've already addressed those findings and implemented changes to make sure that we comply with all of their requests. And so we are now waiting for the final approval from New York State.

So collectively, these 3 things should help drive commercial use in the first half of the year. Transitioning then to reimbursement and the clinical studies to support them. If you think about getting reimbursement, there are key elements to making sure that we can get fully reimbursed for our test. One is getting a code in place that can be used to bill for the test. The second is getting the price of the test approved through the government. And then the third is getting coverage. Coverage essentially means that those payers determine that a test is reasonably and medically necessary for the patients in their programs.

You can see by the colored circles here that we have already obtained a code that we can use to build a test. We also have secured a very attractive rate of $897 for the PancreaSure test. What that means is that when Medicare, the U.S. government insurer that pays for all health expenses for people over age 65, once they do make a coverage decision, those tests will be reimbursed at a very attractive rate of almost USD 900.

Our final focus now is on coverage, essentially convincing payers that the test is medically necessary. And to do that, we have a variety of clinical studies that we've already completed and some that are coming. There are essentially 3 categories of clinical data that these payers look at. The first is analytical validation. Can you accurately measure the biomarkers in the test? We have very, very strong published data to support this.

The second element of the clinical package is clinical validation, essentially, how accurate is the test in detecting cancer and avoiding false positives when cancer is not there. As we've shared previously, we have 3 clinical validation studies completed, and we have 2 of those published, the AFFIRM study, we hope to publish soon and we're pursuing additional publications in this area.

The final area is clinical utility. Essentially, what this means is that the test is useful for guiding clinician decisions and for improving patient outcomes. We have 2 clinical utility studies that are underway, and we are conducting additional studies this year, and some of those studies will extend beyond 2026 and into the future.

If you look at our reimbursement plans in 2026, this just gives you a quick view of what it is that we want to accomplish this year. So we are conducting several quick survey studies that will give us the preliminary evidence of clinical utility that we need to start applying and submitting for coverage. We're going to be initiating a registry study. And what that means is that this is a study where we will gather data on the people who are using the test commercially, as they are using the test, we'll use that to understand things like how it's impacting the decisions of those physicians and what the reaction of the patients using the test is to the PancreaSure test.

One thing that we started doing after the end of quarter 4 was billing insurance companies for PancreaSure tests. Prior to that, we had only been collecting cash from the patients who get the test themselves. But this month, we started billing insurance companies. Without coverage decisions in place, we know that the reimbursement will be limited, but we will generate some limited cash.

Importantly, we also will use this as a way to show those insurance companies that there's demand for the PancreaSure test. I mentioned earlier that a key part of our reimbursement plan in 2026 is to launch additional studies to prove clinical utility.

And then finally, and probably most importantly, we plan to submit for Medicare coverage in mid-2026. So we are actively putting together now the package of clinical data and the summary of that data so that we're ready to submit that to the group that makes those decisions about coverage.

With that, I'd like to hand it over to my colleague, Adam?Backstrom, our CFO, to talk through our Q4 financial results and the company's cash position.

Read the full article on Seeking Alpha

For further details see: