BioPorto A/S (CPH:BIOPOR)
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Status Update

Feb 22, 2024

Moderator

Afternoon, everybody, and welcome to this presentation with BioPorto. BioPorto, early on this morning, announced a new and very interesting strategic plan. With me today, I have the Chairman of the Board, John McDonough, and the interim CEO, Peter Mørch Eriksen. Today's topic is, of course, the strategic plan and everything within it, but you're more than welcome to post other questions. Secondly, I will welcome all the participants, and as always, post your questions just below the video window, and I will forward them to the Chairman of the Board or the CEO. The duration of this event is a little longer than usual due to the scope of the plan, and we will, as always, record this event and will publish it later on today on our platform, and BioPorto will do the same on their homepage.

This presentation is in English, and with that said, I would like to start the presentation by welcoming John McDonough and Peter Mørch Eriksen. Please, John, begin.

John McDonough
Chair of the Board of Directors, BioPorto

Thank you very much, and thank you all for joining us today. As we discuss an overview of our strategic plans over the next three years, with an even deeper focus on our plans in 2024. We are at a very, very exciting time in the growth and trajectory of BioPorto, having achieved FDA clearance back in December for the use of the ProNephro AKI diagnostic product in the use of young adults and the pediatric patient population. This product, and this process that has taken many years, as many of you know very well, is a very, very significant milestone in the history of any diagnostic company. It is rarely achieved, and it is only achieved through intense clinical trials that can demonstrate both the safety and the effectiveness of our product on the use of patients.

We have an enormous responsibility and opportunity now to aggressively enter the market in the United States, to penetrate hospitals both in the United States and, for that matter, around the world, to use our product very successfully, to treat this deadly disease. Our focus now is on the commercial launch of our product, as Peter will discuss in just a few moments, in the United States, along with a more intense focus on the use of our product outside of the United States for use in both adults, young adults, and pediatric patients in all of the countries that are supported by the CE mark, where we already have clearance to enter those markets.

We're very fortunate, as we make this transition as a company into being a commercial growth organization, to have Peter, who obviously has been with the company for many years, has run the company, has played an important role on the board of directors as we continue the process to FDA clearance, and is now leading the organization as our interim CEO, as we focus on expanding the organization and bringing in a team to now take us through the next phases. Peter has worked extremely closely with the board of directors over the past several months in developing a detailed plan of action to commercially launch our product, grow the business, and importantly, put a program in place to run a clinical trial to get broader use of our product in the adult population in the coming years.

With that, I will turn the program over to Peter, who will take you through our strategic plans and an overview of, of our significant opportunity. Peter?

Peter Mørch Eriksen
Interim CEO, BioPorto

Thank you very much, John. Yeah, it has been a tremendous job for the last months that we have tried to put the plan together, and I do thank for all the collaborations we have had between the leadership and the board. I think that it has been significant in what we are doing. Not that I'm going to talk about forward-looking statements, all of you know this. I'm going to start a little, just looking a little backwards, and taking the highlights from 2023 and saying, as John alluded to, probably the most significant day of the life in, or lifetime in BioPorto, we got the clearance for the pediatric use in the US for ProNephro AKI (NGAL). For all of you who have been there long, it's called NGAL. It is the same product for pediatric and young adults.

I do think it's really significant. We are now opening a totally new part of BioPorto, where we are not talking about development only and clinical trials. We are now also talking about growing a business. I'll come further into how big is this business, what is the opportunity. The process is that we have implemented the test on the cobas c 501. You probably saw an announcement in the papers here that we expanded that agreement with Roche this week, that we are also including c 503. And I already have a lot of questions about what is that. That is to make the product future-safe because the c 503 is the new laboratory equipment for the next generation of Roche.

But it's also giving a stamp of approval that they were willing to spend a lot of efforts to get us on the C501, and now they will do the same on the c 503. So Roche really do believe in what we are doing. One of the key things that we have been working with also, in 2023 and before that, is to get into the guidelines. And I can say that we have a steady dialogue with KDIGO to be sure that ProNephro is in the guidelines. Of course, that's going to mean, when we are getting into the guideline, that it is going to be standard of care. And that's absolutely one of the key elements, also one of the triggers, how fast we are going to penetrate a market. If you look at the results for 2023, solid growth.

NGAL was growing more than 25% last year. The results are in line with guidance. You can see that we had a total revenue of 31%. It was a 7% increase. We, unfortunately, were losing some big antibody orders, and that's why it's 7%, because NGAL was doing fine. We had a span of guidance between DKK 56 million-DKK 59 million, and we are now adjusting that to DKK 56 million, angd our cash position is DKK 66 million. We do believe that the annual report is going to be published, for your information, the 4th of April, this year. ProNephro adults, young adults, and pediatric will boost the revenue to more than $100 million in our plans in 2029. This is, of course, looking a lot ahead, but we will, of course, give you updates quarter by quarter and saying, how far are we? How realistic is it?

But we do believe that what we are trying to indicate here is that BioPorto is now, from a development business, going to be a growth business. The successful FDA clearance was the first step. Accelerating the strategy to focus on commercial transaction in the US for clinical testing of pediatric and young adult is absolutely one of the key things we are aiming at. And as all of you know, that we have worked a lot with research use only with hospitals. Of course, these hospitals, we are really eager to get changing from research use only to clinical testing. Furthermore, we have had a lot of discussions prior to that getting the sales up in the European markets or the CE market territories. And now we have the opportunity. The real opportunity is right now because now we have the clinical evidence.

We have efficacy. We have specificity so people can start using it. And also because of the great work who have been done over the last couple of years on research use only, we also know how people are going to use it in a clinical setting. And I do think that's very important when we are out telling about ProNephro AKI. As you all are aware of, we are in a or not we, the chairmanship is in the search of the new CEO and CFO, to strive, to drive this strategy. A lot of questions I have received on this topic is, "Yeah, but Peter, you are making the plan." And, and I'm saying, "No, I'm not making the plan, the company." This time, we have involved the whole company, the whole board, in the planning. So we have a unified plan for the whole company.

I do think that's very important, especially when we have to get new people in, is that we have a unified organization. We have a unified board which all stand behind the plan that we have made. We are going from being a, as I said, a diagnostic innovator with potential to being a growth company. That's probably the change that you're going to see over a year. It doesn't mean that we are not going to talk a lot about clinic-clinical because we are, but it is, of importance to understand that now we are aiming at, at growth. Growth is extremely important when we are looking at the market potential. The next slides, it's giving you an overview of what the aims are. In 2024, we are looking at a revenue target around DKK 6 million, as stated.

That will be pediatric, young adults, the same in both U.S. Then it's also the adults on top of that in the rest of the world. We are going to burn cash primarily due to that we are starting a significant clinical trial on the adult side. If you look at phase two in our plans, it's the same activities, although that we hopefully have our clearance for pediatric young adults in the U.S. approved on multiple machines because right now we have it on the Roche machine platform. And in the period of phase two, we hopefully will have some of the other big partners joining us. We are looking at revenue projections between 2015 and 2025. And as it's stated, if we are at the high end of a range, we are closer to cash flow positive.

But as an investor, you should look more at the growth of the company, the growth of the revenue line because it is essential that we are growing this business. Phase three, we are talking about a + $100 million revenue number. Of course, cash flow positive. Could it be higher? I had that question. Yeah, it could be higher. But right now, we are looking into creating realistic numbers, numbers that we are not disappointing the market with. So I, I do believe that it is safe to say we have, in, in this planning process, been very realistic. If there are any new viewers, I just want to be sure that they haven't heard me talk about it before because AKI, or kidney injury, is an enormous problem. If we are looking at just affected by kidney injury at hospitals, it's one in five adults.

It's one in four children. It's loss of kidney function. It's symptoms decrease in urinary output, swelling, fluid retention, fatigue, shortness of breath. There are a lot of things. It is difficult to diagnose today. I do believe that what we are coming with can bring the prognosis of this illness a little better than it is today and hopefully, long-term, a lot better. We don't have any outcome study, but we do believe in what we are doing. Just to understand why is it so costly to have AKI? If you look at who is in risk of getting AKI, it's in after cardiac surgery. It can be after mechanical ventilation, sepsis, organ or bone marrow transplant, or nephrotoxicity. If you're looking at the increased length of stay by having AKI, increased need of dialysis, and, and worst of all, the overall mortality rate, that is actual numbers.

If you're getting AKI. And I do believe the faster you can detect AKI, you hopefully can, long-term, decrase the numbers of length of stay and, increased need of dialysis. But that's, again, to be proven, after years of clinical use. All of you, you have also seen this. We know that we have one major, competitor. That's serum creatinine, which is a functional biomarker. And the functional biomarker is starting measuring when you actually have a reduced kidney function. You already have occurred damage to your kidneys. If you're looking at what we are doing, after two hours, there is released something called neutrophil cells. And that's, in fact, what we are measuring. And if that number is more than 120 nanograms per milliliter, we know that this patient is in risk of, having kidney problems.

The important is there is not a pill you can eat if you are recognizing it after two hours. But there is a clinical window of opportunities where you can test things, some fluid overload. You can check about their medications, and you can correct that. If you can correct that within the clinical window of opportunity, you really have an opportunity to correct the damage and have no irreversible damage to your kidneys. So that's really key to use the biomarker for that purpose. This one will be on the homepage, because I can see if we have a lot of questions, I have to move a little faster. The strategic roadmap is if you look at what is the real market, the real market is in the U.S., approximately $1.1 billion for adults.

It's $60-$80 million for pediatric and young adults in the US. The rest of the world, the adult is $1.7 billion, pediatric young adults 90-120. To translate the adult side is approximately $2.8 billion, and the pediatric is around $200 million. But it's also important that when we are looking at the whole market, that right now we have RUO. So partnership with the other ones like Roche, Siemens Healthineers, Abbott, and Beckman to really expand the growth in the marketplace. New strategic plan. This is what we have worked with, and this is the key objectives for phase one, two, and three. So one of the key things that you have if you are going to follow BioPorto, this is what we are going to work on for the next many years.

It's initiate usage of pediatric young adults in the US, initiate adult usage in the rest of the world. We are looking at a financing round for $20 billion. We are going to consider to do that other ones. Or if the market and the conditions are that we have to do it over two years, that's what we are going to do. We have not yet decided how we are going to do it. We are going to be open to all opportunities in this area to secure that we are getting the right funding for the company. In the first one and a half year, we are also going to focus a lot about instrument expansion. So in pediatric and young adults. So we assure that we have more than the Roche platform to work from. Strategic and adult trial.

We are in the process of developing the protocol right now. That's really key. We are expecting or hoping to have the first patient in by the end of this year. IVDR is also a key thing. That's the European new regulations. There we are following timeline accordingly. You can see when we are getting out to phase two and three, there's fewer and fewer items because we right now know what, as John was alluding to in the beginning, we are much more specific on the short term. The longer we are getting out, of course, there are some key things that we have to work with, but it is very focused. You can see it's still drive usage in pediatric young adults in the U.S., consolidate adults usage in the rest of the world, do the submission of the FDA clearance in that period.

And, potentially, if there is time focus for it, look at what is the next. But that is, second priority. If we look further on, it's hopefully to really open up the market on the adult in the US and fortify the adult usage in the rest of the world and then continue the expansion of label, in the ProNephro AKI and NGAL area. If we are looking in the period of, 2024 to 2026, we are looking at a, relatively high growth. Why there is 58%-104%, that's because we have the span of DKK 15 million-DKK 25 million in revenue. And again, I think that the key from this is we have to win the pediatric young adults, both in Europe, US and Europe. We have to make strategic partnership.

We have to get the instrument expansion, implement ProNephro in adult clinical usage in the U.S. and in Europe, longer term. Then and then, of course, one of the key things to be able to get the adults cleared is to make a successful funding round. Roadmap for pediatrics. I think I have talked about most of it, and I'm going to just you will be able to read some of this. But it is partnerships. It is distribution. It is to add-on sales reps, but mostly also to, look at what they call medical liaisons to educate the market about the usage of, ProNephro AKI in clinical settings because the ones that we have used, ProNephro or NGAL in, in the research use only were experts. We now have to bring the product out to normal clinics, and they just want to know how we're going to use it.

How is it going to help our patients? So we have to simplify the message that we we are working with. The next thing is here is the plan of the post. In fact, looking at what partnerships do we need to get, talking with ASAP. They are there. And also, this is how we are going to expand. I think the last of these are going in and being ready to be used in the year of 2026. It is taking a little longer than I think that we have said before, but we do believe that we have these all up running before the end of 2026. Roadmap for adults. This is a slide just telling what is it that we which patient groups are we going to enroll in into the clinical trial? It's ICU. It's cardiac surgery. ICU's risk predictors and cirrhosis.

Is that correct, spelled, or pronounced, John?

John McDonough
Chair of the Board of Directors, BioPorto

Yes.

Yeah, this is the group of patients we are going to enroll in our clinical trial. If you're looking at the next page here, you can see that we are planning to submit to FDA, if everything is going to plan, by the end of 2026. And then, it is a 510(k). We are probably going to use our own clearance in pediatric as predictive. So I do think that what we have learned from getting the clearance here and the team have learned is how to do it, how to follow the process, what to do to satisfy the FDA. I think that the only difference between the adults and the pediatric is that pediatrics and young adults, their comorbidities is fewer than if you're taking the elderly group.

I don't know, John, if you want to add to that, but so and again, submission in 2026. It is a 510(k). For you to know the rules, FDA have 90 days, and they can stop the time any anyhow. So we have put in a little more than half a year for the process to they can be able to add questions. Good. The adults, if you're looking at what they're doing in the rest of the world, I do think that the team here is also really trying to utilize the good news that we have with the pediatric. We have data. We have clearance. We can show to them. In fact, we have some adult hospitals in the U.S., which is using it in a clinical setting.

The knowledge we have from there and also from our US, our relatively big country like Korea, we are trying to use all that information to convince the Europeans to also start using; here it's called NGAL because that's the CE-approved name, NGAL. And I do think that what they're doing is really ramping up here and trying to do their best. And I can just see in the months that I have been operational here that the team have been around and have got received some very nice feedback both in Germany, Italy, and also in Holland. So I'm really looking forward to see how fast we can start penetrating the rest of the world's markets. Financial guidance, 2024. Here we have it in Danish kroner.

I'll say in US dollars, US dollars revenue around $6 million, EBITDA -$11 million to $13 million. And again, the key driver here is, cost driver is the adult study. If we look at the pediatric and young adult, it's really, relatively fast going to be a growth machine, for the year. If we look in 2026, we are looking at $15 million-$25 million. And again, I have had the questions about the span. Isn't that big? Yeah. But again, we have just been digging down all the last months in all the details, and we just want to be sure that we are not promising more than we can deliver. And again, cash flow is possible, if we are hitting the high end.

Again, it will be a decision if we can see that we can expand the revenue even further on the cost of the positive cash flow; we will probably take that decision. In 2029, +$100 million, and cash flow positive. And hopefully, we will also see some profitability at that time. But again, this is a growth case, and growth will also really be the key marker for the valuation of the company for the benefit of all investors. So what is it that we have to, again, use these $20 million for? We are unlocking a market of $2.8 billion by using $20 million. And thereof around $15 million is going directly to secure that we are getting the adult trial done. So to maximize our growth and value creation potential, the company is investigating opportunities to boost its financial position.

But I do think the most important is to use this both for growth, but also to finalize the adult study, as mentioned here. And again, we will, as soon as we are back again, the board and the leadership find out what is it we are going to do, what is the openings we have, what is the opportunities we have to raise the capital. Are we going to talk with strategic partners? Are we going to talk with pension funds? Of course, we are going to talk with our current investors. It's always key to be loyal to the investment base that we are having. So it's going to happen in Q2 of 2024. And we will bring you more information when we know the road that we are going to travel. The last thing I'm going to present is not the summary.

I'm not going to repeat that again. But again, remember DKK 15 million-DKK 25 million on the top line in 2026, more than DKK 100 million in 2029. We have to be the winner of the pediatric young adults post in Europe, US, and Europe. And we also have because we now have the data, we don't have the excuse to not start, getting the adults up running. And then it is the adults, FDA submission in 2026. If you're looking at these trigger points, and we are if we are successful there, I foresee that BioPorto have a bright future. The last thing I that's the finance calendar just for info. That's the annual report, April 4th, April 13, the general assembly. And here you can also see the interim reports for Q1, Q2, and Q3. Thank you very much for listening.

Now I'll try to be quiet for a little, Klaus.

Moderator

Thanks a lot, Peter. And thanks a lot, John, for the introduction. You really put your hand on the stove with a very transparent strategic plan. And as always in BioPorto, we have loads of questions, and that's really nice. So let's start up a little you know, just take one step back. I'm sorry about that, gentlemen. But if we look into the FDA approval back in December, and the approval on the Roche instrument, Peter, could you or John elaborate a little on how many instruments do Roche have? And the approval you got, is that for other instruments as well? So from Abbort or from Philips? And by that said, do you have to run through the whole process again? There's a couple of questions about that.

Do you want to answer, Peter, or do you?

Peter Mørch Eriksen
Interim CEO, BioPorto

Yeah, I can try, but John is really welcome to add in here. Roche has it; it is the cobas c 501, which is the dedicated device for the clinical trial. So that's what it's approved for. The, the, I can answer relatively simple. What you call a family system within the Roche family is relatively simple to get it approved to. The key thing here is that, if you're looking at other devices, like Abbott or Beckman also, we have to do testing. You don't have to do the same clinical testing. You have to do an awful lot of analytical testing, and that can be done either at specific hospitals or in-house if we have the machine. So it is a process which, in my mind, is taking 6-9 months. And you can also see that from the plan included.

And then it is, I think it's called a special 510(k). But here I'm not sure, John. So please add in if you disagree.

John McDonough
Chair of the Board of Directors, BioPorto

Yeah, I would just add to that that the approval and the Roche analyzers were approved for cover about one-third of the U.S. hospital market. And the study that you run, special 510(k), is correct as we go to additional machines. You simply need to prove that you get an equivalent result, let's say, on a Siemens machine versus the Roche machine. So you don't have to run patient samples. You just have to prove equivalence, which is a fairly straightforward study to run. Had we had access to all those machines, which is part of the reason why this takes time, it's a fairly straightforward study. So getting access and, in fact, many of, as you might expect, we've already been approached by some of the companies that would now like to see us running on their machine because that's attractive for them.

And you know, we're hopeful that that might be one of the ways that we can get access. I would remind everybody, because sometimes we can forget, we are CE marked. We have a very significant opportunity in Europe, which now gets further intensified because of our FDA clearance. That's important to European hospitals. And in Europe, there's no limitation on pediatric use or young adults. We're approved for full adult usage, and we run on multiple machines. We are highly confident that it's a straightforward process to get the data we need to run on additional machines because we're already doing it in other countries. We just need to have the right data to submit to the FDA.

That is typically a quick 30-60-day process with the FDA, not anything like the long wait we had on the pediatric indication here for the first time.

Moderator

Thanks a lot, Peter and John. So it's fair to say, and you lay out that in your presentation as well, it's not like a stop-and-go strategy. Now you're rolling out on Roche. And parallel to that, you approach the other, the other producers, especially in the US market, where it's much easier in Europe to, to work with this. So let's, let's stay a little in Europe. Would you expect when you apply for, for the new regulations in Europe, IVDR, that you will see enhanced in sales compared to what you have showed so far? I know you changed strategy last year to focus more on NGAL in Europe, and we start to see growth. But would you see different growth rates going forward?

Peter Mørch Eriksen
Interim CEO, BioPorto

Yeah, I think I can give a feedback to that. I think data is running the whole thing. I think the more data we are getting, as I alluded to in the beginning, just pediatric data is going to help us sell in Europe, no doubt about that. Also, the use, it's how they are going to use it is going to help us. So the more data and again, with IVDR, we have to produce data. So hopefully, these data is also going to help us make the case that it's simpler, more people understand how to use it. So yeah, every trial you're doing where you get solid clinical data, it's not just trials, development trials, because that's not always as prudent as an IVDR trial or a trial for the adults.

When you get this information, they're really valuable because they know they are highly regulated. They know that you're not jumping the fence. You are following all the guidelines to be sure that the results you're looking at are extremely solid.

Moderator

Thanks, Peter. And just to stay in Europe for a while, you know, I'm a little nitty-gritty now because we see a little slowdown in growth. And there's a question here from one in the audience in Q4. Is that seasonal? Is just a bump on the road or because all your eyes were focused on the FDA approval?

Peter Mørch Eriksen
Interim CEO, BioPorto

No, I do think if I understand the question correct, that it's mainly on the antibody side. It has nothing to do with NGAL. We lost a couple of antibody orders, and they are bulk orders. So the major reason for the little dropdown in Q4 was not due to lack of attention or focus. It was mainly due to that we were priced out on some bulk orders on antibodies.

Moderator

That's fair. So nothing to do with NGAL. And then if we look into the patents, Peter and John, for the pediatric use and Europe, when do we see expiration coming up? And what can you do to prolong? Because I know you can do that within the industry. Could you elaborate a little on that, please?

Peter Mørch Eriksen
Interim CEO, BioPorto

Yeah, I can. At the current present that we are looking the patents, sorry, we are looking at is running out in 2028 and 2029. Of course, one of the things that we are looking at is, if you're in connections with the data collection, are looking at different algorithms or other things, then we will, of course, look at that to expand it. But right now, it is running out in 2028, 2028, 2029. But we are, of course, going to look. We are not just sitting and waiting. We will look for what are the opportunities. And again, a little going really back, almost 45 or 43 minutes to what John was saying. We have to grow, grow, grow.

And again, we know that always the first one in the market is still after, even when the patents is running out, still going to be the biggest player in the market area. And if we are looking at the opportunity we had as a company with approximately DKK 3 billion, when we are looking further out, there is plenty of opportunity to be an extremely interesting company, BioPorto, in the future.

John McDonough
Chair of the Board of Directors, BioPorto

Yeah, and I would just add to that one. We do believe there'll be ways to extend the patents. And that's an important objective. But really, why are the patents important? Well, because it makes it hard for others to enter the market. I would just add that what's really hard to enter the market is getting FDA clearance and a CE mark and having a body of data. We all know what the level of effort has been for us to get here. So if somebody else wants to get to where we are, they're going to have to go through the same clinical trials, the ups, the downs, the risks, the uncertainties that we just went through.

That may be our biggest barrier eventually of all because it is not easy to get and to achieve what the team has achieved here at BioPorto.

Moderator

Thanks a lot, John. Then there's some questions here about the clarity on profitability. Now you laid out a very ambitious plan and very transparent. So what you mentioned is that you expect some kind of positive cash flow on the high range of your 2026 guidance, but overall profitability in 2029. Peter, if you could elaborate a little because if we have the patents running out on the pediatric just after in the period from 2026 to 2029, how would that, you know, how would that explain your positive expectations to 2029? I know the answer, but I think it's important you just explain it again, Peter. So the pediatric is the first part, and the adult is the second part. Isn't that true?

Peter Mørch Eriksen
Interim CEO, BioPorto

Yeah, it, it is. And, and, and if you're looking at it, first of all, we don't see anyone doing clinical trials, even trying right now, on, on the same areas that we are getting. So that's, let's put 5-6 years on top of that. If, if that's feasible, then we are in 2030. But, but again, the work that has been done, not only last year, the last 10 years with connections to all the pediatric hospitals in the world, the key the connections with all the key opinion leaders, and the same on the adult side, we have a relationship building. I know that relationship building is not everything, but that is going to be our forte.

And again, on a test costing $20 compared to a lot of other things that the hospitals are using, if it's working and they know how it's working, they're going to change it, after my opinion. So we have the opportunity. And if we are growing the business, we are going to continue to be the key company known as the NGAL or the ProNephro company for many, many years to come. Is it going to change? I don't think so. I don't see any new technologies which are doing anything better than what we are doing. But also, one of the things we as a company will be looking at is always improving what we currently are doing also on the product side.

But we are really right now focusing on growing the company in pediatric, both in Europe and rest of the world and in also for young adults. But at the same time, I know that the team here is looking a lot on how are we going to expand the adult usage. So I'm not that scared about the number and the growth of the company. There's plenty of opportunity, even though one was coming in, just an example, that's just going to further help us to bring the message out that AKI is a key thing. And NGAL as an instrument is extremely important because right now, who is telling the story? It's our key opinion leaders. It's our medical liaisons running around telling it. If another company was coming in telling the same story, I think it would just expand the opportunity.

I'm sure of that.

John McDonough
Chair of the Board of Directors, BioPorto

Yeah, yeah, I would just add on there if I could, Peter. Your five years, I think, is correct from the time somebody starts a trial. But remember, they can't start the trial until the patents expire. So it's really 5 in 2020. You're now out to 2034.

Moderator

Oh, that's right. And it's also fair to say the underlying market is growing. So it's not like we are more people on the earth and you have this prevalence. So that's fair to say. Peter, just a straight question here. If you didn't invest your cash flow from the pediatric into the adult use, would you be profitable in 2026 on this indication alone? I know it's a little tricky, but can you give some guidelines?

Peter Mørch Eriksen
Interim CEO, BioPorto

I would not dare to say that. And again, as an interim, I would absolutely not do it, because that would be, again, unfair. I know what our internal numbers look like, but we have a lot of plans. But I must admit, I really think that the people should more listen to what John was saying in the beginning. We are a growth company. If we are on the trajectory of, let's say, we are hitting $25 million, if we could spend just $1 million more and then maybe not be cash flow positive and really expand the journey a lot faster from an investment and evaluation point of view, it would be stupid, sorry, my wording, to just say that we would really like to be cash flow positive and EBITDA positive in 2026.

Moderator

Thanks a lot, Peter. And then if we...

Peter Mørch Eriksen
Interim CEO, BioPorto

I think, John, do you have anything to add?

John McDonough
Chair of the Board of Directors, BioPorto

I would just, I'll take one part of this question, which hasn't been asked. But Peter, I know you've heard it, which is, there's a big range of revenue in 2026. You know, we have a $15 million-$25 million number out there. And why do we have that? The reason why we have that is we haven't launched the product yet. And so the ultimate growth trajectory we know is going to be accelerated. But you want to get some experience under your belt so you can extrapolate exactly, exactly what the usage and adoption rate is going to be. But let me give you an example. I was the president at a company, Cytyc Corporation. We introduced a new diagnostic test for cervical cancer screening.

That was ultimately a major game changer that led to a 70% reduction in cervical cancer deaths in the United States. Within the first three years of adoption, we got up to almost a 10% market share. If we get up to a 10% market share, 8%-10%, we're kind of hovering around the lower end of that $15-$25 million. Now, why would we do better than that there's a bunch of reasons why we would do better than that. Nobody knew about the ThinPrep Pap Test . NGAL has we're out there. We've been used in for research use only. There's a lot of data about NGAL. We're in use in Europe. And perhaps most importantly, if you look at adoption rates for any kind of a medical product related to children, it typically gets adopted much faster.

It just does. There's just a more intensity there. And if you look at the overall incidence of AKI, AKI affects one in five adults that are hospitalized, but it also affects one in three children that are hospitalized, even at a higher rate, especially among the younger children. So you're looking at an incidence rate of AKI that's in the order of 6.5 million patients just in the United States alone. So it is a big number. It is a big problem. And so adoption could go faster, which would put us on the higher end of that range, perhaps even higher than the higher end of that range. But it's a good range.

It's based on facts and statistics, the experience that I've seen with cervical cancer screening, with we've seen it with other diagnostic tests as well. The growth curves almost overlap around the successful game-changing diagnostics. And what Peter said earlier is critically important. It's all clinical data that enters the market, success stories of hospitals using the product. That's what drives more hospital usage ultimately, as you grow the business.

Moderator

Thanks a lot, John. And beyond that, on the other side, if we look into biostatistics databases and a company your size with your potential and an unmet need, you know, it's not unfair to say a market share of 30% after three to four years is achievable. So that with that in mind, because time is running, I'm sorry, gentlemen, but you are looking to fully finance BioPorto for around $20 million. And Peter, you explained, you know, you all options are open. What about some of your partners? Would they be interested in investing in a company like yours? And I know it's hard to answer on, but would that be an approach combined with all the others?

Peter Mørch Eriksen
Interim CEO, BioPorto

That's a difficult question. I'll be around talking with them about partnerships, deals, and if they are interested. I, to be quite honest, I don't know. But there is companies which are interested in BioPorto as such. And again, is that a possibility? I'm not ruling anything out. And again, I also have meetings with Pension Fund. And if they suddenly are saying, "Now you have a clearance. It's not a development company, and it's a growth company. Would we like to invest?" I am going to listen to everybody who is interested in BioPorto and the story about growth of BioPorto.

Moderator

So a pragmatic approach. That's interesting to hear. So, with that said, I know you have other meetings coming up. I think we covered most of the questions. And if not, please, please mail me afterwards, and I will try to answer those I didn't answer. First of all, I will say thank you to John and Peter for participating and rolling out this new, very interesting strategy for the investors in BioPorto. And secondly, I will say thank you to the audience for all the very good questions. So by that said, I hope you enjoy your afternoon, and I will close today's event.

Peter Mørch Eriksen
Interim CEO, BioPorto

Thank you.

John McDonough
Chair of the Board of Directors, BioPorto

Thank you.

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