Good afternoon and welcome to the Shield Therapeutics PLC Investor presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged, and they can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question received during the meeting itself; however, the company can review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll, and I would now like to hand you over to Anders Lundstrom, CEO. Good afternoon to you, sir.
Thank you so much. And good afternoon, good morning, depending where you are in the world. So welcome to Shield Therapeutics trading update covering the fourth quarter and the full year of 2025. My name is Anders Lundstrom. I'm the CEO, and together with me this afternoon is also Santosh Shanbhag, our CFO, and we will take you through the presentation and answer, of course, your questions that will come to the end. So this is our disclaimer. I leave it up for a little bit. And just so you know, this presentation that we will share with you today will be available on our corporate website in the next coming days. So Shield Therapeutics, we are a specialty pharmaceutical company. We are focusing on the iron deficiency and iron deficiency anemia market.
It's a very, very big global market, and in the U.S. alone, there's about 14 million iron deficient patients diagnosed. Our product is called ACCRUFeR or Feraccru, depending on where in the world you are. What we offer these patients is a better tolerated product because the problem sometimes with traditional oral irons is that they lead to gastrointestinal side effects, and thereby the patient cannot continue their treatment. We are today the number one branded prescription oral iron in the U.S. market, and I will go into more details on these things a little bit later in the presentation. The big news for us for the quarter is that we turned cash flow positive, and that, of course, gives us good flexibility going into this year where we can then more easily invest behind our strategic priorities and have much more room than we have ever had previously.
So this is our executive team. We are a very experienced executive team with extensive U.S. commercialization, and across us, we are driving the product ACCRUFeR Feraccru in the global setting. David and Jackie are at our headquarters in Newcastle, and the rest of us are in our Boston office. And in the U.S., it's the only market where we directly sell and market the product ourselves. So what is the problem we are trying to solve for here with ACCRUFeR? It is that most every other oral iron deficiency replacement therapy is a salt. And what happens with this salt is that they dissociate in the stomach. And what then happens is that they cause irritation and damage to the intestinal lining, and the result of that are gastrointestinal side effects. So we know that up to 70% of these patients, they can experience these side effects.
What is unfortunate with that is that in quite a few of those, they will discontinue treatment because the side effects are so bad. In our case, we have a whole different formulation. We're not a salt, first of all. We have a formulation where the actual iron molecule is covered by a MALTOL complex. That makes the product not dissociate in the stomach. Instead, it happens in the upper small intestine. And thereby, we can avoid many of these gastrointestinal side effects. The product is better tolerated. The patient can stay on the product. And we also have an advantage that we actually can then, by doing this formulation, we have a lower iron dose. This gives us a very good place in the market.
Most everybody, as you can see, over 90% of a patient or person with iron deficiency or iron deficiency anemia starts on an oral iron salt. And as I just explained, quite a few of those have these gastrointestinal side effects. And before we were available, the only other alternative was for them to go and get an IV iron infusion. Now, for us, this is a perfect place in the market for us because there is now an oral alternative for these patients as well. So this is our place in the market. So typically, in the U.S. and everywhere else, we are what you could call second line, but that is really no disadvantage at all because most of these patients will have these side effects. And if you can't tolerate it, they have this alternative to go to ACCRUFeR.
That's why we continue to see a very good uptake of ACCRUFeR in the U.S., which we will come into more in detail in a few slides. This is our global footprint. As I mentioned, we sell and market directly in the U.S. We do that together with Viatris. It's a collaboration we have had with them now for over three years. We've been very successful, and we'll come back to the numbers. In Canada, KYE launched the product in the end of last year. In Europe and in the U.K., we have Norgine as our partner. In Korea, we got an approval last year, and we're looking forward to launch now in this year. In China, we expect the filing in the first half of this year.
So that is where we are active in some instances and looking forward to be at the product on the market during this year. And then China will file, probably be on the market in 2027. The new thing also is that in the end of last year, we got the pediatric indication approved in the U.S. So for children older than 10, they can use our capsule. For children below 10, we are submitting a new application in the U.S. and in the E.U. toward the end of this year. In Europe, we have the same setup. So we have filed for those above 10, and we are waiting for a decision, which we likely is going to come during this year as well. Then finally, in Japan, we have a new collaboration. They are going for a different indication.
They're going to try the product in PAH, so pulmonary arterial hypertension, and they are about to start a phase II study in the first half of this year. So this is how we describe the U.S. market. So what I mentioned initially is that about 14 million patients are diagnosed with iron deficiency or iron deficiency anemia. The target market for us is a subset of that, about half of that, so 6.7 million patients. And these are patients that are actively taking iron replacement therapy. But those we focus on is a smaller subset of that's about 4 million patients that we are doing direct-to-consumer marketing. And I'll come back in a couple of slides later to show you the effect of that. And we know these 4 million patients are actively seeking an oral iron treatment online, and that's how we can target them.
We can also target them then with our DTC marketing. The smallest circle, which is where we focus our sales and marketing towards the physician or the prescribers, and our focus is on primary care and women's health primarily. This group we focus on, which is around 25,000 prescribers, they treat around one and a half million patients, so as you can see, there are large numbers, and if you compare that to the number of prescriptions we had this past last year, which was close to 200,000, you can see there's still a lot of growth to be had for us in the U.S. market. This is how we have directed our customer market, sort of direct-to-consumer marketing efforts, so this is basically why we can see three different ways we're doing. We have social media influencers. For instance, on Instagram, we have eight of them.
They were all launched during the course of last year. As you can see, they've reached a significant number of patients via different posts, about 1 million. Our top channels are, as I said, Instagram. It's Facebook, which is still owned by Meta. It's Google, and it's Bing, so different search engines as well. We also do digital advertising, and there you can see we reached them around 4 million patients as well. Then on the physician side, we do marketing, of course, towards physicians, and they are not all big and our prescribers. If you then look to the left, this is where our sales effort is concentrated. As I said, it's women's health and primary care is the majority of where we focus our sales efforts. On the marketing side, on the other hand, we go broader.
And the reason we do that, we know that other specialties like nephrologists, gastroenterologists, hematologists also have large patient populations. And they are outside women's health and primary care. We know these specialists are harder to get to. So what marketing can do for us is to create leads that then can be transferred to our salespeople. And that is why we go broader with our marketing efforts. So just to show you what this could look like, so what I'm sharing here is the growth in the number of prescribers. And these are the number of prescribers that we then detail also. And the reason we're showing new prescriptions is that you have to remember that when you treat iron deficiency or iron deficiency anemia, typically patients take that for three to four months.
Of course, there are those who have a more chronic disease, but most of them take it for three to four months, as I said. Thereby, what we call new prescriptions is something we follow very, very clearly. It's an existing customer that writes a new prescription. And to the left, you can see the development and the number of writers we have in the field. And we're up to about 7,500-ish prescriptions. To the right is where we see the impact on marketing. And these are the number of new writers we see where we never made a sales call. So that marketing works, we know. And these are the way we can measure this. We also know then, of course, how much they have prescribed these writers. And thereby, we know that investing in marketing alone has an impact and has a positive return on investment for us.
In summary, what we are focusing on, as you can see from a marketing point of view, is to increase awareness among those 4 million patients that we know are taking an OTC product or have the product prescribed. That's the awareness piece. We also are this year enhancing our salesforce output. We are targeting other specialists. The reason we're doing that is that we know they have larger patient population. There is a little but with that is that typically with these specialists like nephrologists, oncologists, and gastroenterologists, it takes longer to get to them. Now, since we are where we are, we have a very strong platform, we have the luxury of time to also target them. We continue to drive them in our six top states.
What we have there is we have more salespeople in those states than we have in any other state, so more territories. The last piece, which is also very, very, very important, is that when we have a prescription, we work very hard on the back end, first of all, to make sure that the physicians are submitting what we call a prior authorization. That is a justification why a patient should get our product. That's where it comes in that they would typically have failed on another oral iron before getting to our product. We work really hard on that they submit the PA. We contracted pharmacies that have a PA approval support for the offices.
This is also very important because then they can, in turn, help the prescriber put together the PA so the prescriber or the physician doesn't have to spend time on that. And in the end, we also leverage case managers to contact patients to pick up unfilled prescriptions. You'd be surprised how many patients we in this way can actually get to get the product to because people sometimes do not pick up the prescription. That is a third lever we use a lot. And all of this to get more payers to get our product dispensed to more patients. And by that, I leave the stage to Santosh.
Thank you, Anders. Appreciate it. Hello, everyone. Let me give you a quick update on our 2025 business priorities.
As we had laid out our priorities at the start of the year, we have three key big ones: growing ACCRUFeR net revenues, specifically in the United States, turning cash flow positive by the end of 2025, and launching in Canada, and executing the regulatory strategy in Korea, China, and the pediatric population for ACCRUFeR. I'm excited to report that we have made significant progress and exiting 2025 on a high note across all three priorities. Total revenues for 2025 was nearly $50 million. This includes $46 million from ACCRUFeR revenues in the United States that represents a 56% growth over the prior- year. This came through nearly 200,000 prescriptions in 2025, representing a 33% growth over the prior- year and a net selling price of approximately $223, representing a 21% growth over the prior- year.
Clearly, all of this led to ACCRUFeR now being the number one branded prescription oral iron in the US ID/IDA market. Really exciting times for ACCRUFeR. From a balance sheet perspective, we reported that we turned cash flow positive in Q4 2025. This is a significant milestone for the company, as Anders mentioned at the start of the call. This is the first time in the history of the company that the company has turned cash flow positive. We reported $11.6 million in cash and cash equivalents at the end of the quarter. This represents $1 million in net cash generated, excluding the $2 million debt financing that we put in place through refinancing in Q4. The refinancing was done at significantly improved terms on the senior debt, and we were also able to expand the size of the senior debt available to us to up to $50 million.
That includes $15 million ear marked for M&A. Last but not least, from a global expansion perspective, we launched ACCRUFeR in Canada in Q1 2025 through our partner, KYE Pharmaceuticals. We also got an approval by the FDA for children greater than 10 years old for ACCRUFeR here in the United States. The Korean Ministry of Food and Drug Safety also approved ACCRUFeR in South Korea. And as Anders, mentioned at the start, we also initiated a Japanese phase II trial for ACCRUFeR in pulmonary arterial hypertension, or PAH, in Japan. This is an exciting time for the company. And as you can clearly see, we have executed against our priorities in 2025 and sets the stage really nicely to execute against our strategy in 2026. Let me dig a little bit deeper into some of the details and the trends that we saw in 2025 across the business.
We have shared this slide with you before. This represents the weekly prescriptions in the United States for ACCRUFeR. Clearly, the direction of travel is positive since we fully staffed the sales team in the United States along with our collaboration partner, Viatris. We are right now exiting 2025 with nearly 5,000 prescriptions a week. We continue to see that trend in the first couple of weeks in January as well. As you can see on the slide, there is a seasonality to ACCRUFeR seen in the prior- years. Specifically in Q1, in 2024, as well as 2025, there's typically a softness in the market, primarily driven by the fact that patient insurances typically reset at the start of the year. Q1 2025 had an additional impact of extreme weather, as well as, if you remember, the reorganization of our salesforce.
We expect to continue to see some level of softness in Q1 and a similar seasonality in 2026 as well. We have continued to grow ACCRUFeR in the U.S. across the key three metrics: net revenues, price per script, and total prescriptions. We reported in Q4 2025, $13.5 million in the United States. This came through some significant growth in prescriptions of 61,000 prescriptions, of which 13,000 prescriptions, or 21%, were dispensed as consignment prescriptions that are dispensed at a significantly subsidized price to patients who are not yet reimbursed by payers. The net price in Q4 2025 was $222. That was impacted by an increase in coverage, but rebated prescriptions. Let me give you a little bit more color on the channel mix of ACCRUFeR in Q3 2025 and Q4 2025 that has an impact on pricing.
You can see in both the charts, consignment was moved in the right direction. Consignment, again, prescriptions that were dispensed at a subsidized price while patients are still waiting for payers to provide coverage. That number dropped from 22% to 21%, and we like that trend, and we continue to see that trend. We are seeing more prescriptions covered by whether it's Medicaid or commercial and moving in the right direction. However, as you can see on this slide, the commercial covered prescriptions that were rebated were 18% in Q3 2025, and that increased to 21% in Q4 2025. As we have said before, the pricing of ACCRUFeR will continue to fluctuate as we go through the year. However, we expect the pricing to lie between $222 and about $240-$245 through the course of the year in 2026.
Coming to the balance sheet, we reported that we are cash flow positive in Q4 2025. This was primarily driven by the continued growth of ACCRUFeR in the United States and effective cost and working capital management. We reported in Q4 2025 $1 million in cash generated, and this excludes the new financing that was put in place through the refinancing in Q4 2025. We expect to generate cash in the first half of 2026, including the anticipated seasonality of ACCRUFeR that we have seen in Q1 in the first quarter of the year in prior- years as well. We talked about the refinancing. I wanted to spend a little bit more time on our balance sheet. We refinanced the senior debt with SWK with significantly improved terms. We were able to push out the principal payment terms, principal payments from January of 2026 by about a year.
We were also able to lower our interest rates, and we were also able to expand our available loan to $50 million, including allocating $15 million towards any M&A, specifically to support the expansion of our portfolio beyond ACCRUFeR. We have now drawn $22 million off the $50 million from SWK. The maturity still stays at September 2028. As you remember, we put an accounts receivable factoring program in place of $15 million. We continue to maintain that, and we still have the milestone monetization with AOP of $5.7 million in place. We believe that this provides us enough flexibility to allow us to execute against our strategy in 2026, including expanding our portfolio beyond ACCRUFeR. That brings us to the 2026 business priorities. We have three key business priorities in 2026. Continue to grow ACCRUFeR net revenues.
We plan to achieve profitability in 2026, and we want to diversify our revenue stream beyond adult IDA in the United States. From an ACCRUFeR perspective, there are three key areas that we are focused on. Andy's already alluded to this in a previous slide. Increasing awareness of ACCRUFeR continues to drive the demand in the top big states, in the top six states: New York, California, Texas, Florida, Georgia, and North Carolina. These are the key states that really truly drive the prescription growth of ACCRUFeR and continue to improve patient access to ACCRUFeR. We plan to achieve profitability in 2026. We plan to do this by driving top-line growth while improving our overall margins. We would like to continue to streamline the balance sheet. We have strategies in place to help streamline and make our balance sheet much more efficient and deliver on an operating profit in 2026.
From a diversification perspective, we expect to have two ACCRUFeR launches, one in South Korea and one in the United States for kids 10+ years. We expect to have two regulatory processes executed in China and children in Europe. We are looking feverishly to add a second product into our sales portfolio. Today, our sales team carries one product in the bag. They can easily carry two, if not three, in the bag. We are actively seeking additional products that can be added to the bag, specifically products that may be in a late stage phase III or an FDA-approved product. With this, I would like to hand it back to Anders to close our prepared remarks.
Thank you, Santosh. What you've seen during this presentation is we described to you it's a big market opportunity we have with significant revenue potential.
You have seen the continued growth in ACCRUFeR prescriptions, net revenue, net selling price. And as Santosh explained, unfortunately, there's not a straight line between the number of prescriptions we see and the net revenue. Due to that, the channel makes value from quarter over quarter. But what we're really happy about is the prescription number because these are dispensed prescriptions, so they are real prescriptions. So that continues to grow very, very nicely. Our global partnerships continue to develop at a steady pace. And we never said this initially, but we have milestones coming, and we have typically double-digit royalties from those partnerships. The goal is to be a profitable company by the end of this year.
And very importantly, and actually for the first time ever, as a corporate objective, is to find a second product or partnership to give us a second product to expand the portfolio, which would be a very, very important step for us as a company as well. So that concludes the formal presentation. And by that, we can move on to the Q&A.
Fantastic. Anders and Santosh, thank you very much indeed for your presentation. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the top right corner of your screen. While the company takes a few moments to read those questions submitted today, I would like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via Investor Dashboard.
Stephanie, if I may now hand back to you to take us through the Q&A session, read out the questions where appropriate to do so, and I'll pick up from you at the end. Thank you.
Thank you. Anders, I think you touched on this early on in the presentation, but for anybody who's missed it, we've got a question. Will the company be attempting to patent the new delivery system for the oral liquid suspension? And also, will the company be submitting the new drug application to the U.S. FDA for the oral liquid suspension?
So yes and yes. So the reason we divided the pediatric data up into age cohorts is that for the oral suspension, which then we will apply for a label for those below 10 years of age, we need a whole new manufacturing process to be set up.
Of course, we have manufactured oral suspension because it was used in the study. But when we move to commercial production, we need stability data. And that's the reason why we will submit that during this year when we have the stability data we need from the new manufacturing site. So that is the reason why it's been divided up in two cohorts. And that's the reason also behind that it will be at some point during this year. IP protection on, I see the question here. There is not an extension in IP for the new formulation by itself. So it still goes to 2035.
Thank you. Another one here. So hi, Anders and Santosh. Clearly, high growth never comes in a straight line, but finishing with the full year 2025 with Q4 2025 positive on operating cash flow is impressive.
You've guided for this to be the case as well for full year 2026. How do you expect the phasing of that to be? Are there any quarters which are harder than others? And how will the second half be weighted? Do you expect the growth to be? I think, Santosh, you touched on that earlier with Q1.
I did. I did. Maybe I can take that, Anders, and you can add color. Yeah, I mean, I think we expect to continue to remain cash flow positive in the foreseeable future. We're trying to manage this on a half-yearly basis. There are certain quarters where there is more investment compared to the revenue, and there are certain quarters where there's more revenue compared to the investment. But overall, we have transitioned to be a cash-generating business, and we will manage that on a half-yearly basis and on a full-yearly basis.
In addition to turning cash flow positive, we have also indicated and provided guidance that we will turn EBIT positive. So on a P&L perspective, we expect to turn EBIT positive as well. That will be for 2026, for the full year 2026. So we're excited about that as well. Not a lot of companies in our world today are EBIT positive, and we would love to be one of those few who stand out and are profitable in 2026.
Yeah, and we should just reiterate what you said as well, Santosh. Yes, there is seasonality. There's seasonality in January as well. And also, I mean, the month of July is a month. We see that. We continue to see that. But we continue to see, if you compare year over year, we still have growth in those periods as well.
So that is what we will be looking to as well. So how are we growing compared to the previous year rather than to the previous quarter all the time? So there is seasonality. We just have to accept it. There's not much we can do about it.
That's right.
Yeah.
Thank you. The rate of growth in the U.S. seems to be slowing. Is this a concern for the executive team?
No, no, it's a great question, and you see that. You see, it isn't, yes, it's slowing if you look at the quarters. But the reason really is the price. So the average selling price. So what we're looking at is also what are the prescription numbers? Because the sales force drives in the prescriptions. And then on the back end, as we said, we work on them getting them dispensed, approved and dispensed.
So we have a very nice growth in prescriptions. But as Santosh also mentioned earlier, there will be variability in the net selling price. Not much we can do about that, to be perfectly honest, because we have the number of plans that cover the product that is different pricing. It's just a very complex situation. And for us as a company, we cannot nitpick and say we would only go to those physicians who have certain plans. It doesn't work like that at all. I mean, we also have Medicare where we have very bad coverage, but we don't exclude that either. No, we are very optimistic with our prescription numbers. And with that growth, we will see revenue growth as well. It might fluctuate. And as I said, it won't be straight line between the prescription growth and the revenues you see. And that's just how it is.
There's so many different prices from the different channels. And so if we did not see prescription growth, we would be really worried. So this doesn't worry us at all when we see this type of growth in the prescriptions.
Yeah. And maybe just to add to that, I think it's a fine balance between getting coverage and hence increasing volume. But then those volumes sometimes need to be covered by payers who have rebates. And so this is very normal. This is very common. You see this across all medicines in the United States. As long as, Anders said, we see that increase in prescriptions and they are covered. We do not want to see prescriptions increase through consignment. We want to see prescriptions increase through covered prescriptions. And there will be fluctuations in pricing.
Like I said in my prepared remarks, we think it's somewhere between $220-$240, which is the expected range, plus or minus in any given quarter.
To add to that, I mean, there is a lot of numbers we threw around there. But if you look at the percentage of consignment, it constantly goes down. It goes down 1%-2% per quarter during all of 2025. That is a very positive trend because then again, those are heavily subsidized. That is another sign for us that this is going absolutely in the right direction.
Thank you. Given the expansion of the addressable market, is $450 million still the correct target for peak sales in the U.S.? Yeah, it is.
I mean, if we look at how we grow, if you think about that, we have quite a few years until we reach 2035, which is the end of the IP, but even before that, right? So absolutely, that is absolutely achievable. And now when we are cash flow positive and we start to expand further into other specialties, that again can give us another growth burst because we've been pretty static in focusing on detailing to women's health and primary care. And as we show, thanks to the marketing efforts, which we, in all fairness, we've really been investing in over the last six, seven quarters, that really starts to take off. And there we have even more potential. And thanks then to the leads we get into other specialties, we will continue to be able to get to patient populations we haven't been able to touch before.
That is what also being at the situation where we're at, when we are cash flow positive, we have the luxury of time with our sales force to start going after those physicians that are a little bit harder to see. But we are making inroads with marketing. And then the per prescriber has a larger patient population. That is why we're also optimistic about the growth. In addition, we're launching the pediatric indication this year, which potentially adds another million patients. That's about the number of patients between 10 and up to 18 that are treated for different forms of iron deficiency and iron deficiency anemia in the United States.
Thank you. Have IV sales in the U.S. been impacted by ACCRUFeR at all?
The honest answer is we haven't checked, to be perfectly honest.
You have to put the numbers into perspective, and I try to do that. We had about almost 200,000 dispensed prescriptions last year in a target market for us, which is around 4 million patients. So if IV slows down or not, I honestly don't know. What we measure ourselves against is the other oral items that can be prescribed. And here we are the market leader in the market today, so coming very close to 50% of that segment of the market. So that is where we compare ourselves. There's so many patients available, and we actually don't even look at the IV part of the market. The reason we mention IVs is that they are costly, way more costly than any oral iron.
And sometimes it's not so practical for a patient unless there's a chronic kidney disease or something, other disease where they really, really need it for an IV. That's a whole different situation. The majority of patients, thankfully, do not need an IV. They can do really well on an oral preparation like ACCRUFeR.
Thank you. How do you expect the average net selling price to change in 2026?
Yeah, I think we just may have just answered this, Steph. I think we can continue to see the fluctuations in price, really driven by the channel mix. We continue to see an increase in coverage of our prescriptions. Sometimes they come at rebates. We continue to see a decrease in the consignment channel, like what Andy was saying.
I think the sum of all these pieces are going to land the price somewhere between $222 and $240, unless we get something significant from a policy change in the industry. But we expect somewhere in the $222-$240 price point.
Thank you. You described potentially adding another asset into the portfolio. What might this look like?
It may look like ideally a product that is a specialty product that is within one of the specialties that we cover today to some extent: women's health, nephrology, gastroenterology, hematology. If that product as well has a prescription base among primary care, which some of the specialty products do, yeah, that would be good too. So we're looking very, very broadly, actually. So it could be a range of different products.
So that would be that, which is very broad, would still be a very good fit for us.
And it would be a late-stage phase III or an FDA-approved product. We're not looking to invest money behind an R&D program that will deliver a product to us in three years from now. We're looking for a product yesterday. We need something quick.
Thanks. Please, can you clarify what you mentioned about increasing the sales force in the U.S.? Do you have any plans to expand beyond the six current states?
So yeah, well, sorry if I wasn't clear. What we are expanding with the sales force that is currently 80, we have 40, and the others are 40, is to expand the targets. So what I tried to explain was that today we typically focused on primary care and women's health.
We're expanding the target to other specialties that also treat iron deficiency or deficiency anemia. We are active in many more states than that. We are not active in all 50 states, but we are active in a great number of states. Those six states are the biggest states for us, where California and New York are the two biggest states. So that's where we have the biggest potential as a company. And what I tried to explain was that we in those states have more sales territories than we, for instance, have in Arizona, where we have one. So in California and New York, there's around, I think I'm making an average now, it's about 10-15 territories. That is what I mean.
Thank you. Do you have any plans to launch in any other parts of the world, such as Australasia and Latin America?
We do.
We constantly look at that, actually. And it all depends on what interest we get from other parties because we would partner in all of those markets. Australia is already with Norgine. So that's up to them to decide if they would go to Australia. In Asia, well, we are in Korea now, and we're looking at other parts of the world as well, like the Middle East and Latin America as well. Some of those markets are easier, and some of those markets are harder to go to. But we're constantly looking to see if there are other companies who would be willing to launch the product in those geographies.
Will you be using the financing facility to expand the sales team in the US?
We don't plan. I mean, I think there were a few questions about our balance sheet, about the debt.
I think I'm aligned with the view that we should not be taking more debt right now. I think we're in a strong position from a balance sheet. We don't want to take on more debt. I don't think that would be ideal for the company. So I think what we have right now is the availability of $50 million of debt. We don't plan to take that unless there is a unique opportunity for us from an M&A perspective or an in-licensing perspective or a partnership perspective to expand our portfolio and make sure that that new product that comes into our portfolio is accretive to the business. We may look at debt as an option. We just have that in place so that we have dry powder in case we need to do something.
But we do not plan to use that to support the operations of our current business. I think we are well-funded right now from generating cash on our own to support our business needs for growing ACCRUFeR.
Yeah. And let me add to that. We are constantly looking if we, for instance, if we have territories that are very successful, but a little bit on the larger side, we constantly look if we can make one territory into two territories, for instance. So we are looking at expansions like that, where we could add one or two sales people. We are not looking to add like 10 or 20 or something like that at this stage. And it all comes to, I mean, where we see the opportunity. So we do things like that.
Thank you. When do you expect the China phase III trials to complete?
The actual study is completed in China. It was complete. I think we must have announced that last year at some point, I believe. Or if we didn't, now you know it. It is complete anyway. The reason why this has taken longer on the regulatory side is that in China, we had a very large number of sites, and what they've been doing in China in the end of last year is to make sure that every site is up to the quality standards that they would need to present when they file to the Chinese authorities, and that has taken longer, so the data is in place and so forth, so we now estimate that they should be able to file, I mean, sometime during the first half of this year.
Thank you. What might the profile of revenues be outside of the U.S.?
Can we start forecasting revenues and royalties?
Sorry, can you ask the question again? I missed that question.
Outside the U.S., what might the profile of revenues be?
Yeah, you are seeing what our revenues are. We had $50 million in 2025. $46 million came from the U.S. We anticipate that ratio to remain consistent, at least in the near term. Once we start to see countries like China coming on live, the population there is significant, probably comparable to the U.S. in terms of opportunity. And so that's, I think, when you start to see a true shift in the split. We are anticipating South Korea to launch, like I said, this year. The contribution of that is going to be useful, but I would not call it extremely large compared to what the U.S. revenues are in the near- term.
There are a few milestones that we are expecting to see through these deals that will contribute in terms of revenues and cash as well. Again, compared to the U.S. revenues, those will be relatively smaller.
Thank you. Sorry, last question. What does streamlining the balance sheet mean?
That must have been me. I was using a consulting term, I guess. It says a lot, but doesn't mean anything. No. So we are constantly looking at how do we make our balance sheet more efficient. You saw what we announced in Q4. We refinanced the debt. We like our partners. We really like our partners. They have been extremely flexible and have been working with us as we continue to grow the company and grow ACCRUFeR. So we like our partners. But these debt instruments were put in place when we were in a very different position as a company.
We were not profitable. We were not generating cash. We were burning cash, and we had a higher risk profile in the eyes of these debtors. Today, we are different. We are now generating cash. We expect to be profitable this year. We are growing revenues. ACCRUFeR is making a dent in the market, and our profile as a company is very different from a risk perspective, and so we continue to have conversations with our partners to make sure that the debt instruments we have in place reflect the nature of who we are as a business today, and that's what we mean by continuing to evaluate our balance sheet and strengthen it. At some point, we would love to get rid of some of the debt instruments that we have on our books, and we'll continue to evaluate those options as well.
Thanks, Santosh. Thanks, Anders.
Anders, if I could pass back to you for some closing comments. Okay.
Hold on. There are a few other questions I think we got to address as well instead of then put it in writing. Especially if you try to sell another product, would that affect ACCRUFeR and so forth? No, actually, it will. It will be affected positively because if you have a second product where you can actually visit the same target as we have for ACCRUFeR, it typically actually increases the revenue for the first product as well because you have a second chance to go back to that physician or prescriber. So typically, and that's why we're looking for a product that would overlap with partly the targets we have for ACCRUFeR. So that is why we're really looking to get a second product.
And somebody asked if that would mean we would make money immediately on a second product. It depends on the product, of course. There will always be an investment behind the second product. Well, we wouldn't take anything on unless we thought we would sort of be able to generate more revenue for both products. That is basically what I'm trying to say. So having a second product in the bag of our salespeople typically helps the first product as well. And I think there's a question, Santosh, on the debt facility to repay AOP and so forth. I think there's a big miss. This is a question 36. It's a little bit of a misunderstanding. I think we should address that as well.
Yeah, let me read the question.
Is the debt facility available to repay AOP for the milestone financing if that milestone isn't hit by end of year? Also, can you clarify that you can repay the $5.7 million plus interest? You don't need to give AOP $11.4 million milestone. Yeah, that's a good question. So the structure of the milestone monetization was we received $5.7 million from AOP last year. And in return, we paid them the $11.4 million milestone that we get from ASK upon approval in China. And so that is the current plan. The plan is that we would repay them the $11.4 million. It's more of an in and an out. We get the $11.4 million from ASK, and we pay AOP the $11.4 million. So the net impact on our balance sheet on the day of that payment is zero.
But in return, we got $5.7 million two years ahead of that when it was very valuable to us. The accounting for that is we continue to accrue interest on the $5.7 million at a certain rate, and it hits our P&L as an interest payment. If in case there is a failure on the milestone, which you heard from Anders, the study is done and they're looking to file. So the probability of a failure on the milestone is low. But if that were to happen, then yes, we would have to pay them $5.7 million plus any accrued interest on that specific date. Now, keep in mind, the accrued interest plus the $5.7 million could be lower than the $11.4 million. So it's not that we would have to pay them $11.4 million.
It would be whatever intere st has been accrued on the $5.7 million. Hopefully, that clarifies the question.
Good. I was just going through any other questions. Maybe, I don't know, Anders, if you want to say something about there are a few questions about mergers, takeovers, etc., if you want to give your thoughts there.
Yeah, I can give my thoughts. I mean, mergers, takeovers. I mean, in the quest for a second product, I don't think we're looking. We're not actively looking to do a merger. We could do other partnerships, of course, like the partnership we have with Viatris in the U.S. If someone else comes with a product, we have a partnership of selling the product for them. I'm not saying we will take on another partner who also contributes with sales force. That would be, I think, way too complicated. So that's one way.
If somebody would like to buy the company, well, these are things that typically are outside of our control. We cannot do much about that. If it happens, it happens, and if it doesn't happen, it doesn't happen. I think we're driving the company to grow the company, and that's why we're so proud of it that we actually achieved cash flow positive in the end of last year and going to be profitable this year because that gives us a completely different opportunity to grow the business. Also, the refinancing does that. I mean, it's obvious that they believe that we can continue to grow the company. That's why we have those earmarked potential money for a second product or a second partnership with a product, so that's what we are focusing on 100%.
If somebody comes and gives us an offer, it's up to the board and our shareholders to make a decision for that. And of course, it happens in our industry. But as I said, that's outside what we actually are focusing on.
Thank you, Anders. Can we ask a final question, please, as well? Are there any plans to increase your sales force in the future given your peak revenue target, or do you plan to reach this mostly through marketing?
I think there's a combination there to be had. I think right now, if we can spend an extra dollar or would need to spend an extra dollar, that next dollar will go towards marketing. It is very effective to do marketing. If we continue to grow, and as I said before, especially in sort of high-growth areas, which has a little bit too big geography, we would expand.
As I said, we are already looking to do that. If we would jump from 40 to 80 each, I don't see that happening in the short- term, to be perfectly honest, because we are targeting those prescribers that have the highest potential. And many times, this takes time. But when somebody starts to write and continue to write, it's still the one. This is the same customer. We are, as I said, expanding into more specialists, but again, with the same number of salespeople. If we are to add a second product, it's a completely different story. If we add a second product, yes, we would have to expand our sales force because we couldn't ask the same number of reps to carry two products. So that wouldn't be a lack of focus, I think, for both products in that case. We would probably do that.
And yes, as a rule of thumb, if you do something like that, you typically increase your sales force around 30%, 40%, 50% is typically the number you would increase the number of salespeople with to carry a second product. And then you will make territory smaller. But then you have two opportunities to sort of with your target prescribers as well. So that is typically how we are thinking about it. But that, of course, we would need to see what product it is and so forth. But that would be the moment in time where we would expand the sales force significantly.
Perfect. That's great, guys. Anders, just for some closing comments to wrap up. Thank you very much.
Well, I think we covered a lot of ground. So we're happy about that. We got a lot of very good questions.
Thank you all for those who asked questions. So thanks again. As I said, I mean, the big news for us for the fourth quarter and the year is we turned cash flow positive, which actually gives us a lot more flexibility than we ever had in the past. And thereby, we also stress to you a lot that we are looking very actively to add a second product. But first and foremost, we are focusing on continuing to grow ACCRUFeR. So thanks again. And if there are any additional questions, never hesitate to contact us and ask questions and so forth. We're happy to address as many additional questions as we can. So thanks again.
Fantastic. Anders, Santosh, thank you very much indeed for updating investors today.
Could I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback in order that the board can better understand your views and expectations? This will only take a few moments to complete, and I'm sure it will be greatly valued by the company. On behalf of the management team of Shield Therapeutics plc, we'd like to thank you for attending today's presentation. And good afternoon to you all.