Shield Therapeutics plc (AIM:STX)
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May 7, 2026, 12:47 PM GMT
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Trading Update

Apr 17, 2025

Anders Lundstrom
CEO, Shield Therapeutics plc

Historically, the highest ACCRUFeR sales. We continue to decrease the impact of our consignment business. If you remember, that is an initiative that started in the last quarter of last year. The consignment business is the business where we either give away drugs for free or where the drug is highly, highly subsidized. We started to see the full impact of these efforts in late February and March. The reason we could not see the full impact earlier was mainly due to two events. It was really crazy weather events in January across this country. Secondly, we were fully staffed with our sales force in the new territories by the end of February, early March. Just to give you one other data point, in March, we saw our second highest non-consignment sales ever, only trumped by October of last year.

It is a very, very positive sign. That is why we still are reiterating our goal of being cash flow positive towards the end of this year. The peak revenue potential for the US continues to be very high. The market is stable. We still think we can reach $450 million in peak revenues. Our IP has not changed since we spoke the last time. We still have strong IP until 2035. This is our executive team divided where David and Jackie are in our Newcastle office, and the rest of us are in the Boston office. Across the board, we have a very experienced executive team with extensive US and global commercialization capabilities. What is the problem w ith current treatments of iron deficiency with or without anemia?

As you probably are aware, most patients or people with iron deficiency, they start with an oral ferrous iron. The challenge with those is that they dissociate in the stomach. That free iron causes irritation and damage to the lining of the stomach, causing gastrointestinal side effects. Up to about 70% of patients can experience these GI-related side effects. They include anything from stomach pain, bloating, dark stool, nausea. Some patients even comment that the side effects of oral iron are worse than the symptoms of iron deficiency anemia. We also know that about 60% will discontinue treatment with the oral ferrous irons because of the side effects. Of course, if you continue treatment, there will be a lack of effectiveness as well. ACCRUFeR, on the contrary, is not a salt. It has a maltol shield.

This maltol shield, very simply explained, makes it pass through the stomach. There is no free iron from ACCRUFeR. It is absorbed instead in the upper intestine. That minimizes the risk of these side effects that we have just described on the previous slide. In addition, we can give a much lower dose of iron because we have a much better absorption. That gives us a very unique position in the marketplace with ACCRUFeR or Ferracru . Before ACCRUFeR, if you were on oral iron, you could not tolerate it, and your anemia became more severe, the only other option was to get an IV. Today, you do not need to jump to an IV immediately. You can go to ACCRUFeR. That is why we are uniquely positioned in the market. We are a switch-to product in many instances.

Most of the patients we come across have already tried oral irons multiple times. Our global partners, they continue to progress. As you probably remember, in the US, we're working with Viatris. In Europe, we work with Norgine. In Canada, we work with Kye. Kye just launched a few weeks ago. I had the pleasure of speaking to them earlier this week. They have a very strong plan in place. We look forward to seeing them grow as they get more and more coverage from private and the governmental payers in Canada. In Korea, we're working on the last pieces of the regulatory submission. We still hope to see an approval sometime soon during this year. That is moving on very nicely as well. In China, as we have reported already, the phase III bridging study has finalized.

During this quarter, we hope to be able to report the top-line results. In general, for our partners, with the exception of Viatris, we have royalties and revenue-based milestones of various sorts. As I said initially, there are three important things we are focusing on in the US. The first thing is to increase awareness. This year, we have a larger digital marketing campaign. We are doing direct-to-consumer marketing to a larger group than before. That is the darker blue circle, which represents about 5 million prescriptions. It is not people, it is prescriptions. We know these people are actively seeking an oral iron. The reason we know that is that we can identify that via something that is called social listening. We can be rather targeted in this digital marketing campaign.

In the lighter blue circle, which represents about 2.5 million prescriptions, we also do digital marketing towards healthcare professionals. As an example, here in the U.S., when they then prescribe using the digital prescription, as soon as they are looking up to prescribe an oral iron, a banner is presented then showing ACCRUFeR. That is just one of the ways we can do it. This group represents about 50,000 healthcare professionals and about 1.3 million patients on the patient side. The orange or reddish circle is where we have our sales force. We target about 10,000 healthcare professionals. Those healthcare professionals treat about 250,000 patients. We know these patients have side effects from oral irons. We can figure that out by social listening.

The whole idea of increasing the awareness is, of course, when patients are searching for an alternative for an oral ferrous iron, they will think about ACCRUFeR. They go to the physician. The physician will prescribe it. When we do not then find new prescribers, that information is passed on to our sales force. I also initially mentioned that we have realigned our US sales team. The focus, as I said, is on territories with the highest potential, the best coverage, and historically strong ACCRUFeR performance. On the map to the right is where we have our territories. We hyper-focused in five states, which are California, Texas, Georgia, Florida, and New York, where we have more representatives per territory than we have in the other territories.

The colored in states is typically, or rather, it actually represents where people live in this country as well. Our coverage, which is, as you can see to the right, we have about 55% coverage of the total of 173 million commercially insured lives. A very strong coverage when it comes to the managed Medicaid and the Medicaid Fee for Service as well. These summarize the three initiatives we focus on in the US. The third one that I did not mention before is the first one on this slide. That is to decrease the impact of the consignment business. That is an initiative that we started in the fourth quarter of last year.

What we do is we modify the out-of-pocket pricing to decrease the number of prescriptions we either highly subsidize and thereby lose money on those prescriptions or those we give away for free. That is, we saw the impact already in the fourth quarter. We've seen, as I said initially as well, we've seen very strong non-consignment sales during this quarter. It is something that works and it continued to work. The second was realignment of the sales territories, as I just mentioned. The third one, which is the broader one, is to increase the awareness of ACCRUFeR across patients that are looking for an alternative order and healthcare professionals. By that, I pass over to Santosh.

Santosh Shanbhag
CFO, Shield Therapeutics plc

Thank you, Anders. Hello, everyone. For our friends who have been following Shield for a while now, this slide should look very familiar. For those who are new on this call, we have three key priorities. They are very simple. Grow ACCRUFeR net revenues, turn cash flow positive by the end of this year, 2025, and expand global patient access to our medicines through our partners. Let me take each one of them in order. Grow ACCRUFeR net revenues. Q1 was truly a tale of two halves. The first six weeks, we saw significant weather disruptions in the U.S., specifically the fires in California and snowstorms in the southern states. This led to office closures and affected prescriptions across the market, the entire market of prescription oral iron products.

This was unfortunate for the patients who could not access their medicines, as well as for the people whose lives were disrupted because of this weather. Now, ACCRUFeR was further impacted as we were in the process of realignment of the US sales team, as Anders mentioned before. We were operating with about a 20% vacancy during this time. This means 20% of our territories were without a sales force, sales rep. However, this changed in the second half of the quarter. We saw a pretty good rebound in our performance, reflecting the fully staffed sales force that we now have in place. You can see that in the numbers. In Q1 2025, $6.4 million was the revenue generated from ACCRUFeR net revenues. March represented about 50% of those revenues. You can see that it rebounded, which gives us confidence that this was an acute one-off event.

The prescriptions were 36,800. That's the total prescriptions. We have continued to manage the consignment part of this business, which represents 27% in Q1 2025. As a reminder, the consignment business represents prescriptions that were dispensed at no cost or at a significantly subsidized price and typically does not have reimbursement by payers. The net price for the quarter was $187. Similar to the first half, second half story, March represented $220 in terms of net price. Moving on to the second key priority, turning cash flow positive by the end of 2025. We ended the quarter with $10.5 million in cash and cash equivalents. In addition to this, we also amended our existing $20 million facility with SWK Funding. We have a good relationship with SWK that holds the $20 million debt with Shield.

In conversations with them, they appreciate the dynamic nature of the market and have high confidence in our ability to execute and repay the loan. We aligned with them, and we have hence updated the revenue covenant numbers to be a range rather than a point number, giving us more flexibility to manage our business efficiently. Last but not the least, you can see on the right-hand side, global patient expansion. Kye Pharmaceuticals, as Anders just mentioned, launched ACCRUFeR in Canada. We are excited about that, and we look forward to seeing the growth in Canada as we look into the near term in 2025. Importantly, we had a very successful pre-MDA meeting with the FDA on the pediatric submission. This goes a long way. Up until now, we have been focused on adults with ID/IDA.

This opens the door for us in terms of expanding that label and that population into the kids in the pediatric population. This is very exciting for us just on a personal level as well. With that, I think that's all I had on my slide. I'll hand it back to you, Anders.

Anders Lundstrom
CEO, Shield Therapeutics plc

Thank you, Santosh. Our last slide in the presentation is just a summary. As we mentioned, there is still a very big opportunity in the US and, of course, across the world. We are still scraping the surface on the US market, even as we grow rather strongly, as you have seen over the quarters. Our Shield- Viatris partnership continues to drive strong. It is behind the growth here, of course. As I mentioned, we have three focus areas this year. It is the awareness, increased awareness, the realigned sales territories where we focus our on-the-ground efforts on the best-performing territories, and also continue to work with our consignment business to get that down as much as possible to be able to increase our net selling price.

Our global footprint continued to grow as we went through with launching Canada, the regulatory process in Korea, which we hope we'll see approval during this year, and the study in China. The increased balance sheet, as we mentioned, has given us operational flexibility, and we can really, really look ahead this year and into the future, which is where we can bring the company next instead of just focusing our efforts on raising money to be able to operate f rom a day-to-day point of view. The goal is to be cash flow positive by the end of this year. That ends the formal presentation, and we'll move on to a Q&A.

Moderator

Anders, Santosh, thank you very much for your presentation this afternoon. Ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab situated on the top right-hand corner of your screen. Just while the company takes a few moments to review those questions submitted today, I'd like to remind you that recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via our investor dashboard. As you can see, we received a number of questions throughout today's presentation. Stephanie, could I please ask you to read out the questions and give responses where appropriate to do so, and I'll pick up from you at the end?

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Yes, of course. Thank you. Thank you, Santosh. Thank you, Anders. If I could just go to the first question, please. The first question we received was, will Shield be moving manufacture to the USA to avoid further forthcoming pharmaceutical tariffs?

Anders Lundstrom
CEO, Shield Therapeutics plc

It is a very timely question these days. Our situation right now is that, first of all, we have stock that lasts us at least 12 months. We are well prepared in that. The other comment of that is it is too early to say. In general, as you probably have seen from other companies, what is the real impact, to be perfectly honest, even if they put a 10% or 20% tariff on the imported goods from abroad? Quite frankly, the value of pharmaceuticals, being orals, injectables, biologics, whatever it is, the typical cost of goods is max, maybe 10%-15% of the actual price of the products that come in. That is why the impact is not that big, which some of you may have seen that JNEA said the other day. Of course, we do not know what the end will be.

They say they will come. Then again, as you've seen with other tariffs, they come and they go. They get negotiated. For us, in general, it will have a very small impact. We have no current plan to move our manufacturing out of France at this stage.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you, Anders. Next question. Could you give an indication of the extent of the impact on market segment prescriptions for oral during Q1 as a result of the weather and how your own volumes moved in comparison with reference to the wider market?

Anders Lundstrom
CEO, Shield Therapeutics plc

Santosh, I think that you will look into the total market and things like that.

Santosh Shanbhag
CFO, Shield Therapeutics plc

Absolutely. I mean, without going into the details of every single product, there are lots of prescription OTC products, specifically for iron deficiency in the market. When we look at the market as a basket or the market basket, the whole market has taken a similar turn as ACCRUFeR in Jan and Feb . You can attribute that to weather. We do look at ourselves compared to some of the leading products in that market basket. We are one of the top two products prescribed right now, which is a pretty big move for us from about a year ago where we were not the top prescribed products. We see the same trend even for those bigger branded products in the market. This is not anything unique to ACCRUFeR as of now.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thanks, Santosh. Do you think a material proportion of March revenues were a catch-up from January and February's delayed sales?

Anders Lundstrom
CEO, Shield Therapeutics plc

I'll start, Santosh. What we typically see is, sales we see in March typically starts earlier. Just to give you a couple of facts. When a prescription is written, it takes about one to two weeks before it's filled, right? There's a lag there. Of course, that is not the filling of a prescription, so i.e., when the patient gets the ACCRUFeR out of the pharmacy, it's not when we get our revenues. Our revenues are actually two steps behind that. First, the drug needs to get to the pharmacy, which is something we call Ex-f actory sales. We don't get paid from those either. We get paid when our main wholesaler, Cardinal , buys from us. They are a step before the Ex-f actory.

What we see in March is something we started to see already in the second half of February. I can also tell you that what we see in April is a continuation of what we sort of see in March. That is why there is not a direct correlation in that sense. March is a huge step up, of course. What we see in March is in line with what we would expect to see going forward. Santosh?

Santosh Shanbhag
CFO, Shield Therapeutics plc

No, I think you hit it. I don't have anything more to add.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Why was the net price lower in March at $220 than in Q4 2024, which was $237?

Anders Lundstrom
CEO, Shield Therapeutics plc

Yeah.

Santosh Shanbhag
CFO, Shield Therapeutics plc

You know, the way the price is calculated is based on the number of units that we transfer in terms of title. When we sell to the wholesaler, that's when we recognize the revenue. You do look at the distribution of the different channels that support the sale in that quarter. Typically, in Q1, you do have what you call an insurance reset. Most patients reset their insurance on January 1st. There are different commercial payers and different Medicaid payer approaches that take place in Q1, especially in terms of copays, etc. That impacts how much we buy down in terms of copay versus how much we get reimbursed. The net effect of that typically is lower in Q1, and that's what we expected to see, and that's what we saw in March.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Next question is, are there any other safeguards that we're going to be implementing to protect against any other adverse events that may occur in the US, similar to the weather events we experienced in January?

Anders Lundstrom
CEO, Shield Therapeutics plc

W e do not have those powers. Maybe some will soon have those powers because it has been rather devastating, what we have seen, especially with the fires in California, of course. T he freakish thing with the weather is that there is snow in Florida, there is snow in other southern states. When there is snow there, it means absolute chaos because people cannot get out of their households and so forth. No, t his is what we call force majeure. We cannot safeguard ourselves from any of that. What we can do is to continue to do what we told you we are focusing on. That is what we put our focus on. That is, we are very confident in the things we have implemented in the beginning of this year when it comes to the three initiatives. We will continue to support fully.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Somebody's asking, what is the impact having for the direct-to-customer marketing initiatives having at this early stage?

Anders Lundstrom
CEO, Shield Therapeutics plc

What we did already last year, we launched a smaller campaign last year with digital marketing towards healthcare professionals and a little bit towards patients as well. We know these campaigns have a positive return on investment. That's why we continue to invest and invest more dollars behind those this year. The direct effect this year is too early to tell, actually. We need more data, but in the months to come, and probably when we speak again after the second quarter, we can show you what the impact is from these campaigns. We know from, as I said, from previous data that impressions lead to prescriptions. That's why we're doing it.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Can you describe the average duration of a patient that has been prescribed ACCRUFeR? For example, how many months do they tend to buy the product? What is their patient lifespan with ACCRUFeR?

Santosh Shanbhag
CFO, Shield Therapeutics plc

Again, I think it depends on the type of patient, between a commercially- covered patient versus a Medicaid-covered patient. They have different behaviors and different profiles. On average, we see on the commercial side, somewhere in the two and a half to three. Sometimes it can bump up to even close to four. On the Medicaid side, we typically see somewhere in the one and a half to two refills. That means they get the first prescription, and then they get an additional one and a half refills, so a total of two and a half. Similarly, on the commercial side, they get the first prescription, and then they get an additional, let's call it three. They get a total of four months of product using our product. Anything to add there, Anders, that?

Anders Lundstrom
CEO, Shield Therapeutics plc

No, no. I think you're spot on. That's the closest answer we can give. We, of course, looked into that data as well. We have that type of data.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Somebody's asking as well about sort of the ongoing dependency for existing sales and prescriptions in relation to our sales reps. How long does it take for a physician not to need any sales handholding?

Anders Lundstrom
CEO, Shield Therapeutics plc

A physician, is that what you said?

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Yes, physician.

Anders Lundstrom
CEO, Shield Therapeutics plc

It's an interesting question. You have to make a distinction here between a product that is for a chronic therapy and a product that is for an intermittent therapy. Typically, for products like ours that Santosh just explained, they take three to four months. You have to be there more often compared to a product that is for a chronic therapy because, of course, a patient on a chronic therapy would be on that therapy chronically. That's what the word implies. We are dependent on having our sales territories covered because they make a big impact, as we have told you, which was for us sort of the slow start of the year because one-fifth of our territories didn't have people in them. That's very important we have that.

It's very important that they go out and remind the prescribers about ACCRUFeR because still at this point, at least over 80% of the patients are on an OTC product. As Santosh explained earlier, yes, we see on those who are exclusively prescribed, we're doing well. S till the great majority of the market, still today, are OTC products. An OTC product can be prescribed as well. That's why we have the data. We don't have data on products just picked up from the pharmacy. The true market is probably even bigger, just to finish my last sentence. They are very important. They are our most important driver of revenue, to be perfectly honest. The other activities we do, like the marketing, digital marketing, and so forth, is to support the salespeople.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. How confident are you that you'll be cash flow positive by the year end?

Anders Lundstrom
CEO, Shield Therapeutics plc

We said it several times on this call. Being a public company, you typically would not say we would reach that if we did not believe that we would reach that because that would not be honest and transparent. We are very confident that we can still reach cash flow positivity by the end of the year for 2025.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Can you please remind us why it was decided to restructure the sales force to focus on certain states?

Anders Lundstrom
CEO, Shield Therapeutics plc

T hat's a great question. With the data we collected since we launched the full sales force with Viatris in the middle of 2023, we almost had a full one and a half years of data. You learn and see where you have the impact you want from having a territory covered by a salesperson. Having all that data, it turned out that all territories were not viable. They were not profitable. There are a number of factors to that. Typically, the factor is that the coverage isn't strong enough. Even though we do have, in general, good coverage, there are places where we have very poor coverage. That's why we decided to create these 80 new territories with the three variables, as I described.

Highest potential, which means the highest total number of prescriptions, best coverage for ACCRUFeR in relation to that territory, which we actually have because then again, we have that data too. Historically, where did we do well with ACCRUFeR? Why is the last point important? It is important because typically, it takes a salesperson much, much longer to get the first prescription or first and the second than it would be to get the third, the fourth, the fifth, and so on. Thereby, we focus on that. The reason we focus more on five states is just because the opportunity is bigger. We can already see now in March, this works. It pays off. That is why we do it. Having said that, it does not mean that we would not continue to expand when we see good results from these 80.

We could expand back to 100. We could go even further, right? This is where we are right now. When we sort of analyze this, we'll make the next decision.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Can you describe as well what percentage of the market is Medicare, Medicaid, and what percentage is private pay?

Santosh Shanbhag
CFO, Shield Therapeutics plc

Yeah. I mean, you can assume that when we look at our numbers, consignment represents about 27%. That's the number that we gave. These are patients who are probably not covered by insurance, or they have some level of insurance, but they're still waiting for their insurance to make a decision on what coverage they get. There's a split of commercial versus Medicaid within that percent. The rest of the business, about a third of it is Medicaid, and then the remaining is commercial. A third, a third, a third, I guess, would be a good way to think about the business split.

Anders Lundstrom
CEO, Shield Therapeutics plc

Cash is a very, very small portion. I mean, it's a single percentage. Yes, there's a part that is cash pay upfront as well.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. How does the actual Q1 revenue numbers compare against those which were budgeted or forecasted for the quarter?

Santosh Shanbhag
CFO, Shield Therapeutics plc

We have not provided any guidance on what our Q1 numbers were expected to be, what our internal budgets are, or what our internal forecasts are. Obviously, we are not thrilled by Jan, the first six weeks of the quarter, but we are pleased by what we saw in March. Hopefully, that helps answer that question.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Do you feel that further funding may be required this year?

Santosh Shanbhag
CFO, Shield Therapeutics plc

We haven't said that we needed additional funding at this point.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Sorry, one more question here. We've got where did you feel that the reorganization occurred? Was it in the Shield team, the Viatris team, or both?

Anders Lundstrom
CEO, Shield Therapeutics plc

Great question. It's both. Whatever we do in the market, we always do together with Viatris. That's both teams. Now we have 80 territories. We have 40 each. Any activity in relation to marketing, market access, or sales is always a joint decision between the two companies. We do everything hand in hand.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you. Just the last question in relation to similar, are the Viatris reps still focused at 100% on ACCRUFeR, or are they responsible for selling other Viatris products simultaneously?

Anders Lundstrom
CEO, Shield Therapeutics plc

100% on ACCRUFeR.

Stephanie Hicks
Director of Corporate Operations and Head of Investor Relations, Shield Therapeutics plc

Thank you.

Moderator

Anders, Santosh, thank you for answering all those questions you can from investors. Of course, the company can review all questions submitted today and will publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Anders, could I please just ask you for a few closing comments?

Anders Lundstrom
CEO, Shield Therapeutics plc

Sure. First of all, thank you for taking part in our Q1 update for Shield. If there are other questions we did not get to today, we will write an answer, and we will post that as we did the last quarter so you can all see the written answers as well if there are questions, as I said, questions we did not get to. By that, I mean, thank you all for taking the time. See you in about three months.

Moderator

Santosh, thank you for updating investors today. Could I please ask investors not to close the session, and you should now be automatically redirected to provide your feedback in order that our management team 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'd like to thank you for attending today's presentation, and good afternoon to you all.

Anders Lundstrom
CEO, Shield Therapeutics plc

Thank you.

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