Operator
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.
I would now like to hand you over to Anders Lundstrom, CEO. Good afternoon to you, sir.
Anders Lundstrom
Thank you so much, and good afternoon, good morning, depending on where you are in the world. Welcome to Shield Therapeutics trading update covering the fourth quarter and the full year 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 then answer, of course, your questions when we come to the end. This is our disclaimer.
I leave it up for a little bit. Just so this presentation that we will share with you today will be available on our website, corporate website, in the next coming days.
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 US alone there's somewhere 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 US 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 a good flexibility going into this year where we can then more easily invest behind our strategic priorities and have a much more room than we have ever had previously. This is our executive team.
We are a very experienced executive team with extensive US 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 US is the only market where we directly sell and market the product ourselves.
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.
What happens with the salt is that they dissociate in the stomach. What then happens is that they cause irritation and damage to the intestinal lining, and the result of that are gastrointestinal side effects.
We know that up to 70% of these patients, they can experience these side effects, and 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, smaller intestine.
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.
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.
This is our place in the market. Typically in the US 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 they can't tolerate it they have this return to go to Accrufer.
That's why we continue to see a very good uptake of Accrufer in the US, 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 US. We do that together with Viatris.
It's a collaboration we have had with them now for over 3 years, and 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 UK, we have Norgine as our partner. In Korea, we got an approval in 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. That is where we are active in some instances, and looking forward to have the product on the market during this year.
Then China will file, then 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 US.
For children older than 10, they can use our capsule. For children below 10, we are submitting a new application in the US and in the EU towards the end of this year.
In Europe, we have the same setup. We have filed for those above 10, and we are waiting for a decision, which 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 are going to try the product in PAH, pulmonary arterial hypertension, and they are about to start a phase 2 study in the first half of this year. This is how we describe the US market.
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, 6.7 million patients.
These are patients that are actively taking iron replacement therapy. Those we focus on is a smaller subset of that, it's about 4 million patients that we are doing direct-to-consumer marketing.
I'll come back in a couple of slides later to show you the effect of that. 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 1.5 million patients.
As you can see, there are large numbers, and if you compare that to the number of prescriptions we had dispensed last year, which was closer to 200,000, you can see there's still a lot of growth to be had for us in the US market. This is how we have directed our direct-to-consumer marketing efforts.
This basically, 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, and as you can see, they've reached a significant number of patients via their different posts, about a million.
Our top channels are, as I said, Instagram, it's Facebook, which is owned by Meta, it's Google, and it's Bing, different search engines as well. We also do digital advertising, and there you can see we reached then around 4 million patients as well.
Then on the physician side, we also do marketing, of course, towards physicians and our prescribers. If you then look to the left, this is where our sales effort is concentrated.
That's, 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.
Outside women's health and primary care, we know these specialists are harder to get to. What marketing can do for us, it's to create leads that then can be transferred to our salespeople, and that is why we go broader with our marketing efforts.
Just to show you what this could look like, what I'm sharing here is the growth in the number of prescribers. These are the number of prescribers that we then detail also.
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 3 to 4 months. Of course, there are those who have a more chronic disease, but most of them take it for 3 to 4 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.
To the left, you can see the development then of 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 of marketing, and these are the number of new writers we see where we've never made a sales call.
That marketing works, we know, and these are the ways 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 a product prescribed. That's the awareness piece.
Then we also are, this year, enhancing our sales force 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 with a very strong platform, we have the luxury of time to also target them. We continue to drive demand in our six top states, and what we have there is we have more salespeople in those states than we have in any other state, 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 will typically need to fail on an other oral iron before getting to our product. That we work really hard of that they submit the PA.
We contracted pharmacies that has 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, the prescriber or the physician doesn't have to spend time on that.
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 the product to because people sometimes do not pick up their prescription.
That is a third lever we use a lot. All of this so to get our product dispensed to more patients.
By that, I leave the stage to Santosh.
Santosh Shanbhag
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 a million dollars 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 earmarked 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.
As Anders mentioned at the start, we also initiated a Japanese phase 2 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 sales force. We expect to continue to see some level of softness in Q1 and a similar seasonality along 2026 as well.
We have continued to grow Accrufer in the US 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 with 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 are, 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 come covered by whether it's Medicaid or commercial and moving in the right direction. However, as you can see on the 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 the $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 a million dollars in cash generated, and this excludes the new financing that was put in play placed 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 Q 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 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. Anders already alluded to this in a previous slide: increasing awareness of Accrufer, continue to drive the demand 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-plus 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 3 or an FDA-approved product. With this, I would like to hand it back to Anders to close our prepared remarks.
Anders Lundstrom
Thank you, Santosh. What you've seen during this presentation is we've described to you it's a big market opportunity we have with significant revenue potential.
You've seen the continued growth in Accrufer prescriptions, net revenue, and selling price. As Santosh explained, unfortunately, there's not a straight line between the number of prescriptions we see and the net revenue due to the channel mix vary from quarter over quarter.
What we're really happy about is the prescription number, because these are dispensed prescriptions, they are real prescriptions. 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.
Very importantly, and actually for the first time ever as a corporate objective, is to give us a second product to expand the portfolio, which would be very very important step for us as a company as well. That concludes the formal presentation, and by that we can move on to the Q&A.
Operator
Fantastic. Anders, 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 take a few moments to review 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 your 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 earlier 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?
Also, will the company be submitting the new drug application to the US FDA for the oral liquid suspension?
Anders Lundstrom
Yes and yes. The reason we divided the pediatric data up in two age cohorts is that for the oral suspension, which 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 study, but when we move to commercial production, we need stability data. 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.
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. I see that question here.
There is not an extension in IP for the new formulation by itself, it still goes to 2035.
Thank you. Another one here.
Hi Anders and Santosh. Clearly, high growth never comes in a straight line, but finishing with the full year '25 with Q4 '25 positive on operating cash flow is impressive.
You've guided for this to be the case as well for full year '26. How do you expect the phasing of that to be?
Are there any quarters which are harder than others? How will the second half weighted do you expect the growth to be?
I think, Santosh, you touched on that earlier with Q1.
Santosh Shanbhag
I did. Maybe I can take this, Anders, and you can add further.
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. Overall, we have transitioned to be a cash-generating business, and we will manage that on a half-yearly basis and on a fully yearly basis.
In addition to turning cash flow positive, we have also indicated and provided guidance that we will turn EBIT positive. On a P&L perspective, we expect to turn EBIT positive as well.
That will be for 2026 for the full year 2026. 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.
Anders Lundstrom
We should just reiterate what you said as well, Santosh, is that there is seasonality, there's seasonality of January as well, and also, the month of July is a month. We see that.
We continue to see that. What we continue to see, if you compare year-over-year, we still have growth in those periods as well.
That is what we will be looking to as well, how are we growing compared to the previous year rather than to the previous quarter all the time. There is seasonality, we just have to accept it, not much we can do about it.
That's right.
Santosh Shanbhag
Yeah.
Thank you. The rate of growth in the US seems to be slowing.
Is this a concern for the executive team?
Anders Lundstrom
No, no, this it's a great question, and and you see that You see, it is a Yes, it's slowing if you look at the quarters, but the reason really is the price, the so the the average selling price. What we're looking at is also what are the prescription numbers, because that is the sales force drives in the prescriptions, and and then on the back end, as we we've said, we work on them getting them dispensed, approved and dispensed.
We have a very nice growth in prescriptions. As Santosh also mentioned earlier, there 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 that cover the product, that is different pricing, it's just a a very complex complex situation. For us as a company, we cannot nitpick and say we would only go to to physicians with a certain plan.
It doesn't work like that at all. We we also have Medicare where where we have very bad coverage, but we don't exclude that either.
No, we we are very optimistic with with our prescription numbers, and with that growth we will see revenue growth as well. It might flat fluctuate, and it, as I said, it won't be straight line, between the prescription growth and and the revenues you see.
That's just how it is. It it's there's so many different prices from the different channels, and that's us.
If we did not see prescription growth, we would be really worried. This doesn't worry us worry worry us at all when when we see this this type of growth in the prescriptions.
Santosh Shanbhag
Yeah. 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.
This is very normal, this is very common, you see this across all medicines in the United States. As long as, 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 to 240 is the expected range, plus or minus, in any given quarter.
Anders Lundstrom
To add to that, there's a lot of numbers we throw around here, but if you look at the percentage of consignment, it constantly goes down. We lose 1, well, it goes down 1% to 2% per quarter during the whole of 2025.
That's a very positive trend, because then again those are heavily subsidized. That's 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 US?
It is.
Anders Lundstrom
If we look at the how we grow, if you think about that we have quite a few years until we reach 20, 35, which is the end of the IP, but even before that, right, absolutely, that is absolutely achievable. 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.
As we show, thanks to the marketing efforts, which, in all fairness, we've really been investing in over the last six, seven quarters, that really starts to take off. There we have even more potential.
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.
We are making inroads with marketing, and then they, 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 US been impacted by Accrufer at all?
Anders Lundstrom
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 the target market for us, which is around 4 million patients.
If IV slows down or not, I honestly don't know. What we measure ourselves against is the other oral irons that can be prescribed, and here we are the market leader in the market today, coming very close to 50% of that segment of the market.
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 it's a chronic kidney disease or something, other disease where they really really need, of course, an IV. That's a whole different situation.
The majority of patients, thankfully, do not need an IV, that they can do really well on an oral preparation like Accrufer.
Thank you. How do you expect to the average net selling price to change in 2026?
Santosh Shanbhag
I think we 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 increase in coverage of our prescriptions, sometimes they come at rebates, we continue to see a decrease in the consignment channel like what Anders was saying. I think the sum of all these pieces are going to land the price somewhere between the 222 and the 240, unless we get something significant from a policy change in the industry.
We expect somewhere in the 220 to 240 price point.
Thank you. You described potentially adding another asset into the portfolio.
What might this look like?
Anders Lundstrom
It may look like ideally is 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.
We're looking very very broadly, actually, so that it could be a range of different products. That would be that, which is very broad, would still be a very good fit for us.
Santosh Shanbhag
It would be a late-stage phase 3— Yeah. Phase 3.
—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 3 years from now.
We're looking for a product yesterday. We need something quick.
Right.
Thanks. Please, can you clarify what you mentioned about increasing the sales force in the US?
Do you have any plans to expand beyond the six current states?
Anders Lundstrom
Yeah. Sorry if I wasn't clear.
What we are expanding with the sales force that is currently 80, we have 40 and Viatris have 40, is to expand the targets. 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 iron deficiency anemia. We are active in many more states than that.
We're 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.
That's where we have the biggest potential as a company. 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.
In California and New York there's around, I just make an average of, it's about 10 to 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?
Anders Lundstrom
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. 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 the folks are harder to go to, but we constantly look into if there are other companies who will be willing to launch the product in those geographies.
Will you be using the financing facility to expand the sales team in the US?
Anders Lundstrom
We don't plan. I think there were a few questions about our balance sheet, about the debt.
I think I am aligned with the view that we should not be taking more debt right now. I think we are 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.
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 a 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 very well funded right now from generating cash on our own to support our business needs for growing Accrufer.
Santosh Shanbhag
Let me just add to that. We're constantly looking if we, for instance, have territories that are very successful but a little bit on the larger side, we constantly look if we could make one territory into two territories, for instance.
We are looking at expansions like that and where we could add one or two salespeople. We're not looking to add 10 or 20 or something like that at this stage, and it all comes to where we see the opportunity.
We do things like that.
Thank you. When do you expect the China phase 3 trials to complete?
Anders Lundstrom
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.
The data is in place and so forth, we now estimate that they should be able to file, sometimes during the first half of this year.
Thank you. What would profile of revenues be outside of the US?
Can we start forecasting revenues and royalties?
Anders Lundstrom
Sorry, can you ask the question again? I missed that question.
Outside the US, what might the profile of revenues be?
Anders Lundstrom
You are seeing what our revenues are. We had $50 million in 2025, 46 came from the US.
We anticipate that ratio to remain consistent, at least in the near term. Once we start to see countries like China coming online, the population there is significant, probably comparable to the US 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 US 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 US revenues, those will be relatively smaller.
Thank you. Sorry, last question.
What does streamlining the balance sheet mean?
Santosh Shanbhag
That must have been me. I was using a consulting term, I guess.
It says a lot, but doesn't mean anything. No, 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.
We like our partners, but these debt instruments were put in place when Shield was 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.
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. That's what we mean by continue 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 can pass back to you for some closing comments?
Anders Lundstrom
Hold on. There's a few other questions I think we could address as well instead of then put it in writing especially if you start to sell another product, will that affect Accrufer, and so forth.
No, actually, 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. Typically, and that's why we're looking for a product that would overlap with partly the targets we have for Accrufer.
That is why we really looking for to get a second product. Somebody asked if we will make money immediately on a second product.
It depends on the product, of course. There will always be an investment behind a second product.
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.
Having a second product in the bag, our salespeople typically helps the first product as well. I think there's a question, Santosh, on the debt facilities, would repay AOP, and so forth.
This is question 36. It's a little bit of a misunderstanding.
I think we should address that as well.
Santosh Shanbhag
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 the $11.4 million milestone? That's a good question.
The structure of the milestone monetization was we received $5.7 million from AOP last year, and in return we pay them the $11.4 million milestone that we get from ASK upon approval in China. 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, the net impact on our balance sheet on the day of that payment is zero. In return, we got $5.7 million 2 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, the probability of a failure on the milestone is low.
If that were to happen, then yes, we would have to pay them a $5.7 million plus any accrued interest on that specific day. Now keep in mind, the accrued interest plus the $5.7 million could be lower than the 11.4.
It's not that we would have to pay them 11.4, it would be whatever interest 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.
Anders Lundstrom
I can give my thoughts. Mergers, takeovers, in the quest for a second product, we're not actively looking to do a merger.
We actively could do other partnerships, of course, like with the partnership we have with Viatris in the US. If someone else comes with a product, we have an option for selling the product for them.
I'm not saying we will take on another partner and also contributes with sales force. That would be, I think, way too complicated.
That's one way. If somebody would like to buy the company, well, these are things that's typically outside what 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 that we actually achieved the cash flow positivity 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. It's obvious that they believe in 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. 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 the 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?
Anders Lundstrom
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 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.
Many times this takes time, but when somebody starts to write and continue to write, 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 that would be a lack of focus, I think, for both products in that case.
We would probably do that. Just as a rule of thumb, if you do something like that, you typically increase the sales force around four, 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 territories smaller, but then you have two opportunities to sort of meet your target prescribers as well.
That is typically how we're 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.
Operator
Perfect. That's great, guys.
Anders, just for some closing comments to wrap up. Thank you very much.
Anders Lundstrom
I think we covered a lot of ground, we're happy about that. We got a lot of very good questions, thank you all for those who have asked questions.
Thanks again. As I said, 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 it's thereby we also stress to you a lot that we are looking very actively to add a second product.
First and foremost, we are focusing on continuing to grow Accrufer. 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. Thanks again.
Operator
Fantastic. Anders, Santosh, thank you very much indeed for updating investors today.
Could I please ask investors not to close this session, as you will 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 will be greatly valued by the company.
On behalf of the management team of Shield Therapeutics plc, we would like to thank you for attending today's presentation, and good afternoon to you all.
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