Shield Therapeutics plc ($STX)
Earnings Call Transcript · May 5, 2026
Highlights from the call
Shield Therapeutics plc reported its Q1 2026 earnings, highlighting a 54% year-over-year revenue growth to $18.4 million. This includes $9.9 million from ACCRUFeR sales, which grew 54% YoY. The company achieved EBIT profitability, aided by a $7.9 million milestone payment from its Chinese partner. Management reiterated its focus on expanding ACCRUFeR's market presence and exploring new product acquisitions. Despite challenges such as the new prior authorization requirement for Medicaid in New York, the company remains optimistic about its growth trajectory.
Main topics
- Revenue Growth: Q1 2026 revenue grew 54% YoY to $18.4 million, driven by ACCRUFeR sales and a milestone payment from China. Management stated, 'We reported $9.9 million in total ACCRUFeR revenues in Q1 2026.'
- Medicaid Prior Authorization: New York Medicaid now requires prior authorization for ACCRUFeR, which could impact Medicaid sales. Management is pivoting focus to commercial channels, stating, 'We immediately pivoted the sales team to focusing on our large base of business that we already have in New York for commercial.'
- Pediatric Market Expansion: ACCRUFeR received approval for pediatric use in the U.S. and Europe, with a full launch in April 2026. Management noted, 'We launched our full launch for the pediatric expansion indication on April 1.'
- Digital Marketing Initiatives: Digital marketing efforts have increased brand awareness, with 90,000 website visits in March. Management emphasized, 'We leveraged and tailored our advertising efforts, and we leverage social media influencers to reach these consumers.'
- Cash Flow and Profitability: The company achieved EBIT profitability in Q1 2026, supported by milestone payments and effective cost management. Cash and cash equivalents increased to $12.4 million.
Key metrics mentioned
- Revenue: $18.4M (vs $11.9M in Q1 2025, +54% YoY)
- ACCRUFeR Revenue: $9.9M (vs $6.4M in Q1 2025, +54% YoY)
- EBIT Profitability: Achieved (Driven by milestone payments)
- Cash and Cash Equivalents: $12.4M (vs $11.6M at end of 2025)
- Total Prescriptions: 53,000 (vs 39,000 in Q1 2025, +44% YoY)
- Net Selling Price per Script: $190 (vs $187 in Q1 2025)
Shield Therapeutics demonstrated strong revenue growth and achieved profitability in Q1 2026, driven by ACCRUFeR's performance and strategic milestone payments. However, the new Medicaid prior authorization requirement in New York poses a risk to future sales. The company's focus on digital marketing and pediatric market expansion are positive catalysts, while the search for a second product remains a strategic priority. Investors should monitor the impact of Medicaid changes and the company's progress in product acquisition.
Earnings Call Speaker Segments
Unknown Attendee
AttendeesGood afternoon, and welcome to everyone that's joining us today, and a big thank you from the Shield Therapeutics team. We will be going through the Q1 2026 trading presentation today. [Operator Instructions] The company might not be in a position to answer any -- all questions today. However, we will review all questions and where appropriate, share responses following today's presentation. The webinar today is being recorded and will be published on the Shield Therapeutics' Investor website. I'd like to now hand over to the Shield Therapeutics CEO, Anders; CFO, Santosh; and CCO, Andy.
Anders Lundstrom
ExecutivesThank you, Polly, and we'll go to the slides. Good afternoon, good morning, everybody. So we're here to review our first quarter trading update, and we can go to the next slide immediately, Polly actually. So you introduced us all know so you know who's on the call. This one before that, which is our disclaimer. You go back one, please. Actually, the disclaimer still is there. Thank you very much. So this is our disclaimer. And also, in addition, this presentation will be posted on our website later this week. And as you heard initially, we have received a number of questions. Thank you so much for that. And those questions we will not have time to answer today, we will post in writing. We'll answer in writing and post that as well. So we'll answer as many questions as we can during this broadcast. So we can take the next slide, please. So this is our executive team. And across us, we have very extensive commercialization expertise, not only in the U.S. but actually globally as well. The gentlemen with the 3 red circles are with us on the call today. And together with Lucy, we are all based in our Boston office and David Childs is based in our headquarters in Newcastle, U.K. We can take the next slide, please. So before we jump into the quarter results, we -- a few weeks ago, actually on April 19, we made public our annual report and our audited 2025 financials. Just a couple of highlights there. We reached as you probably have seen $50 million of revenue last year, which was a very nice growth over 2024, about 54% growth. We also reached our cash flow breakeven in the fourth quarter of last year. And also importantly, on the last bullet there in the middle, we now have -- since we renegotiated our debt, we have about $15 million allocated for a business development opportunity. So if we were -- because we're actively looking to find a second product, and now we have some money to execute that, which is a very important step for the company. And then to the right, we continue to grow our global footprint. Canada launched, and they continue to perform well also in the beginning of this year. We got the FDA approval for the pediatrics or rather the adolescents part of this indication where the U.S. have approved everybody over 10. We got an approval in Korea, where they're now looking at the actual commercialization, hopefully, sometime this year. It all depends on how quickly we can get price and reimbursement in Korea. And as we very recently also made public is that we have the first patient in, in our PAH trial in Japan. We can take the next slide, please. So just a few words about us at Shield. As you know, we work in iron deficiency with or without anemia and we continue to grow a lot, as you've seen, but there's so much more growth to be had, and we will break that down on a later slide in the presentation today. We're also very proud of it. We are the #1 prescribed oral iron in the U.S. market today. And the last point is what I would like to mention is also we have very strong IP through 2035. So we have quite a few years ahead of us to reach what we believe is our peak revenues around $450 million. We can take the next slide, please. So what is it with iron deficiency? And what is it that we can -- what is it that our product ACCRUFeR can contribute with that. So most every product that you treat iron deficiency with is a ferrous salt. We are not the ferrous salt, but I'll come back to that. What happened with these products is when they dissociate in the stomach, they cause irritation. And actually, as a matter of fact, it's not only the stomach, they actually cause irritation and inflammation through -- also through your guts. So if you have an inflammatory disease, for instance, it's not a good thing that you continue to increase that inflammation. And as a result of this, up to 70% of patients, they experience some type of GI-related side effects. And many times, these side effects are so bad, so they cannot continue to take the treatment, so they discontinue. And of course, that is where we come in. And we can take the next slide, please. So what ACCRUFeR does -- next slide, please, is that we're not salt, first of all. And we have a maltol shield that covers the iron, and it actually covers the iron through the stomach until it's absorbed in the upper intestine. And if it's not absorbed, it still covers the iron. So we cause much, much fewer of these gastrointestinal side effects. And that is really our claim to fame here. And that is also resulting in that the patient can stay on therapy much easier compared to all the other ferrous salts. We can look at the next slide, please. So that gives us a very interesting position in the marketplace. So most every patient starts on a ferrous salt also over 90% and before ACCRUFeR, the only other alternative was to get an IV. Now we are very nicely positioned before you would get to a very expensive IV iron infusion. So we are a second-line treatment in every aspect, which is no disadvantage because there's so many patients that start on an oral iron, which is a ferrous salt, cannot tolerate it. And then the only alternative before was to get an IV is where we come in here as perfectly faced in the middle. And that is also why you see continued growth with ACCRUFeR in the U.S., especially because there are so many patients that need a different oral product than a ferrous salt. We can look at the next slide, please. So I just going to update you what happened then this year when it comes to our global footprint. In the U.S., we still work with -- still a copromote with Viatris in Canada. KYE continued to have success with reimbursement and have today about 80% of the commercial lives covered. So that they continue to do very, very well there. Norgine is the same as it was before. And as I mentioned, Korea already. In China, we filed the submission, and we're looking forward to an approval sometime next year, which is a very interesting, exciting market to be able to launch in. In the U.S., we have the indication for children or adolescents over 10. In Europe, we have the positive opinion. So in Europe and in the U.K., we will have an approval now in June that is for children 12 and above, so a slight difference towards the U.S. And we -- as I said, in Japan, we now have the first patient in, in our PAH study, completely different indication in orphan. It's a Phase II study, but very, very exciting development for ACCRUFeR. Next slide, please. So that's my last slide. So I will now leave the floor to Andy. Please, Andy.
Andrew Hurley
ExecutivesAll right. Thank you, Anders, and thank you all for joining. I'm going to walk through a commercial update, speaking to some of the highlights of last year and Q1 of this year. We had a few milestones that we achieved for the brand. And one of them came last year. And right on this slide, you can see what that is, is ACCRUFeR for being on the market for only about 2 years, became the #1 branded prescription oral iron in the United States. So that was nice to see with the efforts behind sales and marketing being able to achieve that accolade. Next slide. So this slide breaks down our target market for ACCRUFeR. So when you look at prevalence, there's about 25 million people with iron deficiency with or without anemia each year. That breaks down to about 14 million diagnosed patients with iron deficiency with or without anemia. So then we break it down from there to a target market of about 6.7 million patients, ages 10 to 64 that are taking either the over-the-counters or prescription products. And within our digital marketing efforts alone, we've been able to reach over 4 million patients who are looking for a new treatment. As Anders mentioned before, they have distress and tolerability issues with the other agents. So they're actively online looking for a new treatment. So we combine our digital marketing efforts with a sales team that targets about 25,000 physicians and roughly 1.5 million patients. So that's really how we're looking at things from both a sales and marketing perspective. Next slide. So ACCRUFeR's payer coverage remained high throughout all of 2025 and into 2026, with about 70% of our lives covered by insurance in the United States. And what we've done is we've optimized our sales force to overlap the large volume states that have significant open access for ACCRUFeR across both the commercial and the Medicaid channels. And when we break this down even further, we have 6 big states that account for 2/3 of ACCRUFeR's overall commercial volume and about 80% of the Medicaid volume. And when we look at the commercial channel specifically, we see that about 2/3 of our total volume comes from the commercial channel. And in 2026, we expect that number to grow. Next slide. So for 3 straight years, we've seen a similar trend in our ACCRUFeR business. So we see strong prescription growth in all quarters, but we have seen a seasonality that negatively impacts Q1 of each year. And this largely happens because of high deductible resets and prior authorization prescriptions that need reapprovals in Q1 for existing prescriptions. So that's not a phenomenon for Shield only. That's industry-wide. Q1, you're having those high deductible resets. And typically, that's what we've seen in our Q1. But if we look at Q1 of this year versus Q1 of last year, we drove 53,000 prescriptions in Q1 of this year from that perspective. So we were doing quite well. And overall, we had 46% increase versus last year. So overall, this has been a really good quarter, and we continue to see momentum that's going in very much the positive direction. Next slide. When we talk about our covered prescriptions, that's in the orange line. And we look at the covered prescriptions and consignment prescriptions over the last 18 months. So that we see that we grew our Covered prescriptions from last year through the rest of 2025. And we had our normal dip in Q1 of this year. And -- but we had our covered prescriptions grow over last year by tune of 49%. So we're really going in very much the right direction. When we look at consignment, consignment reduced significantly from the overall 2025, and we had roughly about 21% of our overall business was related to consignment, and that's down from where we were in the past. And we consistently see our efforts to try to get more covered prescriptions versus consignment. And we expect that consignment business to be flat throughout 2026. And consignment went up slightly, you can see in Q1 due to a decision we made to consign the high deductible prescriptions that were in Q1 that were covered by insurance in Q4. And if we didn't do that, we would have lost those prescriptions due to the high deductible resets that I mentioned. So this allowed us to keep those prescriptions and gain revenues in the year from a percentage of those patients that would have reached and did reach their deductible in Q1. So this was a conscious effort where we got a little bit more consignment in Q1, but it's going to produce more revenue for us longer-term by keeping those patients in the funnel and being able to get them to be covered over time. Next slide, please. So I want to talk about the situation that we saw happen in New York on April 23. And we learned that New York Medicaid changed ACCRUFeR from requiring no prior authorization for a prescription approval to now requiring a prior authorization. And this was not something that came by surprise. We always knew that the Medicaid states that are losing a lot of the federal subsidies are having to go into cost optimization programs. And in New York, that's no different. We saw 3 full years with no prior authorization needed in New York Medicaid. And PAs for branded products are very common. And in fact, across our top 6 states, we have PAs in place for the vast majority of them. So this is something that we're well aware of, and we've encountered in our past. So what did we do? So in hearing the decision from New York Medicaid to make this change, we immediately pivoted the sales team to focusing on our large base of business that we already have in New York for commercial. And in fact, we have, as I mentioned, 2/3 of our overall business already comes from commercial. So we're very adept at driving this channel. And in New York specifically, New York represents our #2 state overall for commercial business. So this is something that we were planning for at some point. We've been obviously leveraging the status that we had in Medicaid and did so for over those 3 years. And like we've seen in other states in the past, we pivoted very successfully to driving the commercial business. And we anticipate that that's going to have the same success in New York with the efforts that we're already applying right on that very day of April 23. Next slide, please. So this slide speaks to our digital marketing initiatives. And we know that patients with iron deficiency are very active online, searching for therapeutic options to address the tolerability issues that they see with generic and OTC iron products. We leveraged and tailored our advertising efforts, and we leverage social media influencers to reach these consumers, and this has generated a lot of awareness for ACCRUFeR. In fact, with our latest data that we had for March, we saw over 90,000 ACCRUFeR website visits from consumers that were fueled by our digital initiatives. So this is working. We are learning with every month that goes by on how to tailor our messaging and our targeting in a more specific way. And that will be a very big part of our strategy throughout 2026 and beyond to both consumers and to our providers. Next slide, please. So this slide breaks out how we're doing across our specialists that prescribe ACCRUFeR. So sales team continues to grow ACCRUFeR by predominantly focusing on primary care and women's health targets. You can see that there is an other bucket in green, and that's the other specialists that these sales efforts have been focused on. And actually, the sales team has seen an increase in prescriptions from other specialists largely because of the impact that digital marketing has had on key specialists like hematologists, oncologists, nephrologists and our newest specialty, pediatrics, which came from our label expansion that occurred in December of last year. So marketing, we know has a real ability to reach far more providers than sales. And through our focused strategy that we're implementing, we've expanded our reach to these specialists who have higher volumes of patients with iron deficiency with or without anemia. So this will be continued expansion, and I expect that we're going to see more and more coming from our specialists as we continue to go and put the marketing efforts towards them as well as sales. And last slide. So in summary, we have a focus on 3 major drivers for ACCRUFeR. One, we're going to continue to leverage digital marketing and with a primary focus on awareness across patients looking for a better iron option. And we're going to continue to optimize the impact of our sales team as our second priority focus. And that's going to be through a focus on high prescribing providers and hyper focusing on our top 6 states. And then lastly, we're going to make sure and continue to make sure that patients have access to ACCRUFeR by educating our offices on approval requirements and broadening our pharmacy network across all of our key states. So that wraps up my section, and I will hand over to Santosh.
Santosh Shanbhag
ExecutivesThank you, Andy, and hello, everyone. Jumping into 2025 before I hit Q1 financials. As Anders said, we had a really strong 2025, approximately $50 million in total revenues. That's a significant growth over 2024 where we reported $32.2 million. Of the $50 million, $46 million came in from ACCRUFeR in the United States, which is a 56% growth over the prior year. We had a pretty strong net price in 2025 as well of an average net selling price of $223. We are very pleased with the performance of ACCRUFeR 2025, and we'll talk a little bit more about how that has helped us in 2026. We reported a loss for the year of $17.7 million. That is lower than what we had in 2024 of $27.2 million, primarily driven by the growth of ACCRUFeR in the United States. And then last but not least, cash and cash equivalents was $11.6 million. And as we reported earlier, we did achieve our ability to turn positive cash flow in Q4 2025, which was a significant milestone for the company. So overall, a really strong financial year from a 2025 perspective. Next slide, please. Q1 and full year 2026, as we have said before, are based on 3 key priorities: growing ACCRUFeR net revenues in the United States; driving profitability for the full year of 2026; as well as diversifying our revenue stream beyond the adult IDA in the United States. Let me hit each of these priorities one after the other. On the total revenues, we reported $18.4 million in Q1 of this year. $7.9 million of the $18.4 million came in from a milestone payment by our Chinese partner ASK. ACCRUFeR represented $9.9 million of the $18.4 million. This represents a 54% growth over Q1 2025. The revenues were generated through 53,000 total prescriptions, of which 26% were consignment, slightly higher than what we saw in Q4 of last year. This had an impact on the net selling price of $190. The consignment, as Andy mentioned, was driven primarily by the fact that we had a few high deductible patients who were commercially covered patients in Q4 that we grandfathered in into Q1, and those patients were considered consignment patients while their insurance was being looked at in Q1 2026. Driving to achieve profitability. We reported EBIT profitability in Q1 2026. Again, this is primarily driven by the fact that we had $7.9 million in milestone payment by ASK in China. Cash and cash equivalents was $12.4 million compared to $11.6 million at the end of the year. Positive cash flow was again primarily driven by the fact that we had managed our AP balances and working capital in Q1. And on the final priority, diversifying our revenue stream beyond adult IDA in the U.S. We did receive our Chinese NMPA accepting the MAA submission for ACCRUFeR in China. We are very excited about that and our partner, ASK is continuing to push to receive approval and launch in China. And finally, EMA also approved FeRACCRU indication for kids greater than 12 years in Q1 of this year. So a strong quarter across the board in Q1. Let me jump a little bit deeper into the financials for Q1. Next slide, please. These are the 3 key metrics that we have shared with you on a consistent basis, total prescriptions, net selling price per script and ACCRUFeR net revenues. As you can see on the left side, total prescriptions grew 44% compared to Q1 of 2025 on the retail prescription side from 27,000 prescriptions to 39,000 prescriptions. In Q1, like I mentioned on the prior slide, 14,000 prescriptions came in from consignment. That represented 26% of our total prescriptions in Q1 2026, slightly higher than what we had seen in the prior quarters and had an impact on our net selling price in Q1 2026. You can see in Q1 2026, our net selling price was $190 compared to $187 in Q1 2025. And on the right chart, you can see we reported $9.9 million in total ACCRUFeR revenues in Q1 2026, again, representing a 54% growth compared to $6.4 million in Q1 2025. Overall, we are pleased with the performance of ACCRUFeR in Q1. We did see the typical seasonal insurance dynamics playing its role in Q1, especially in Commercial and Medicaid -- through the commercial and Medicaid plans. March was a reasonable rebound for us in Q1, very similar to what we saw last year same time, and that has allowed us to progress into Q2 with good momentum for ACCRUFeR. Next slide, please. And that was the last slide I had. I'll hand it back to Anders to wrap it up, and then we can go into Q&A.
Anders Lundstrom
ExecutivesAnd if I unmute, you'll be able to hear me. Thank you, Santosh. Thank you, Andy. So what we've shown here is, I mean, as Andy showed, the market is very, very big still, and there's a lot of room for us to grow. And what really is driving the growth is the combined effort by sales and marketing, but marketing is really what drives the awareness, which is a key point to continue to grow, to reach what we estimate to be our peak revenues around $450 million. We see consistent growth in ACCRUFeR prescription net revenue and net selling price. And I mean, as we have explained and what happened to those high deductibles because of the high number of consignment in relation to previous quarter is actually about 2,000 prescriptions that we grandfathered in. And that drives down the net selling price. But what it really does is actually increase revenues as we go on. So that was a conscious decision to do that. You see on -- we keep expanding our global footprint, and we're very excited about that because that is potentially future revenues from more markets than we have today. We're still driving to achieve profitability by the end of this year. And we're actively looking to find a second product to be able to expand our portfolio and make full use of our sales force where we can easily absorb another product into the same bag as with the sales structure we have today. I'd like to say thank you to Santosh. This is Santosh's last quarterly presentation, and he will leave us. I saw there were some questions about that. He will move on to another exciting opportunity. Luckily, I mean, over the almost 3 years, Santosh has been with us and over the last 18 months, he's leaving a company that is in so much better financial shape and in general shape as well, we have actually reached -- we are in a whole different level as a company than what we were when he joined us. So we are very thankful for all the contributions of Santosh. So thank you so much, Santosh.
Santosh Shanbhag
ExecutivesThank you. Thank you, Anders. Thank you for your kind words. And as Anders indicated, yes, I have decided to step down as the CFO of Shield effective June 1. And this is to pursue a leadership role at a pharmaceutical company that is focused on oncology, helping bring cancer drugs to patients is something I feel very passionate about. I want to take the opportunity to thank the Shield Board of Directors and the senior exec team is one of the strongest teams that I have worked with. Their vision and passion to support patients and to make Shield successful is unparalleled and can never be doubted. We -- like Anders said, I think we've built something very special here, turning the business around over the last few years, growing ACCRUFeR year-after-year, turning cash flow positive and potentially becoming a profitable business does not happen by chance. I continue to believe in the promise of Shield and ACCRUFeR. And to be honest, as a shareholder in the company, I will be eagerly looking forward to these quarterly updates, sitting on the other side of the table. Again, thank you for trusting me with my role over the last 2 years. It's been an honor. And with that, I think we'll open it up for questions.
Anders Lundstrom
ExecutivesFor questions. Thank you, Santosh.
Unknown Attendee
AttendeesThank you so much for your presentation all. And yes, as we said, we'll now open the door -- floor up to some of the questions from the investors today. So the first question. I would appreciate some context around the recently disclosed requirement for prior authorization of ACCRUFeR for Medicaid in New York. Is the company talking to the New York state authorities to enable ACCRUFeR to become an authorized treatment for Medicaid? What other mitigations is the company following? And what is the estimate of the impact on revenues?
Andrew Hurley
ExecutivesYes. Let me take that one, Polly. And yes, ultimately, as I mentioned upfront, this was something that was anticipated at some point. So we've always been in preparation mode for when that situation in Medicaid would be different. So the mitigation plans that we put in place across both our team and the Viatris' team is to pivot to the large prescribing commercial providers that we've already been calling on, and then we've added in a number of also some additional providers that can give us a greater band to drive that commercial business. As I mentioned before, New York is our #2 highest volume state for commercial business. So we've already been doing that. We're just going to intensify the effort in doing so. Are we talking to the -- to New York Medicaid? Yes, we are. We've been in constant contact with them and trying to get greater context to understand how we can share to the providers on the clinical criteria to get ACCRUFeR approved because there is still that availability to them. They just need to understand what the process is in order for ACCRUFeR prescription to be approved. So this is not new to us. We've seen this happen in past states. And Texas at one point was our largest Medicaid state, and that has quickly become our largest commercial state for the efforts that we put behind it when this type of a situation happened. So we're confident in our sales and marketing teams to be able to lead through this and be able to leverage all that is in front of us on the commercial side of the business.
Unknown Attendee
AttendeesAnd so how are you going to really ramp up sales exponentially over the next quarters? And what do you see as being peak revenue?
Anders Lundstrom
ExecutivesI mean, Andy just gave an expression of the pivot that happened in New York. In all other states, we continue on the path we've already started. So I mean, there is nothing really new happening there. We see continued growth. So I mean, we are driving, as I said, towards the peak revenue we see quite a few years out, but we still continue to grow. And I know there's a public number out there of what the growth has, for instance, been in total number of prescriptions in April. We see a growth of about 22% so far in the first -- that will probably be the first 4-ish weeks of April over the same period of January. So we continue to see growth. So that is basically how we reach all our goals.
Unknown Attendee
AttendeesRight. On a national basis, what percentage of sales are Medicaid and what percentage are commercial? What's the difference in price obtained between the 2? You mentioned New York, but other states also created PA requirements.
Anders Lundstrom
ExecutivesI mean, Andy, you can answer that part. We've never really broken down what the difference in price is between different channels. First of all, it's rather complicated because there are so many different, what we would say, channels. So we've never shown that -- we show you the net selling price, which actually is the net selling price anyway. So that doesn't really matter what the price difference is between the channels. But you can go in a little bit deeper maybe on the...
Andrew Hurley
ExecutivesYes.
Anders Lundstrom
ExecutivesWe did show you on the percentage. That's why we showed you and that's why we made it public as well. New York was and is still our biggest Medicaid state. But Andy, you can continue on that.
Andrew Hurley
ExecutivesYes. I mentioned on one of the slides that 2/3 of our total volume comes from commercial channel. So that is still a large driver of our business. Medicaid channel represents anywhere between, say, 25% when you factor in other channels such as cash. So 25% to 30% would be on average. We do see that that is going to be impacted to some degree. We don't know to what degree yet. It's way too early for us to understand the impacts. So we're not going to just sit back, of course, and wait for that to occur. We're going to proactively drive to the channels that we've done incredibly well with, which is commercial. And if any business is to come from the Medicaid side by working with the state and just understanding the clinical criteria better and better as time goes on, then we expect to get sales from Medicaid. So that's something that's still going to happen. It's just our primary focus in the state of New York is to continue to drive the commercial business. That's already represented at being our second biggest state for commercial.
Unknown Attendee
AttendeesAnd are you still actively seeking acquisitions?
Anders Lundstrom
ExecutivesSantosh, can you take that?
Santosh Shanbhag
ExecutivesYes, I can take that, Anders. Absolutely. I think we have stated that as an objective for the company as a goal for the organization, and we have stated it publicly as well. We do have an infrastructure that can easily accommodate more than one product. It's an efficient use of our infrastructure if we had a second product. So we are on a hot pursuit for multiple products. Our sweet spot is most likely going to be a late-stage Phase III or a product that is looking for an FDA approval. We have evaluated products that have been FDA approved, and we have not really liked any of those. We have pursued products that have been in Phase III anxiously awaiting data and our strategy is to wait until we see the data, which helped us recently where we were waiting for the data on the product and the product update. So we'll be very selective in how we go after these products, but it is absolutely a key priority for us to bring in other products to the company into the sales bag.
Unknown Attendee
AttendeesWhat is the Board's expectation of the effect on growth of the PA authorization change? Have you made any progress on the second product in the bag?
Anders Lundstrom
ExecutivesI mean, we've never -- again, we don't give a revenue forecast or anything like that. It comes back to what we said, we're pivoting to the commercial side of the business opportunity we have here as well. And on the second product, yes, we say that what we're doing as well. So this is that.
Unknown Attendee
AttendeesAnd the trading update states that New York Medicaid new prior authorization criteria mean that Medicaid prescriptions will fall. I've checked the New York new Rx website and they state that ACCRUFeR can only be prescribed with a doctor form providing medical need. As far as I can see, this means nothing changes. Patients already need doctors sign up for medical need with intolerance to 2 standards, iron versions and ferritin levels being low. What else is causing the worry?
Anders Lundstrom
ExecutivesSo I can answer that. So that is exactly the new criteria. That wasn't the criteria prior to April 23. So we've seen this change in other states as well. What we need to figure out now is what exactly do we -- what do we need -- what information is needed for the PA to go through. So sitting here today, we don't know that yet. It's only basically a week. But in other states, when we figure it out, yes, we see prescriptions go through. So that's where we're at. So that's why we believe, yes, we will keep a portion of the Medicaid sales in New York. But we're not waiting for that to happen. We're not sort of banging the drum on the same physicians because those physicians who have prescribed for Medicaid will continue to prescribe for Medicaid, but we shift our focus until we have full clarity of the situation, what is needed for the Medicaid to be approved basically.
Unknown Attendee
AttendeesAt current growth rates, the company will only hit $250 million of revenue by 2035. When we hit patent expiry. What is the strategy to accelerate growth to hit the stated ambition of $450 million and to also hit it well beyond -- well before patent expiry to maximize returns? What are the limiting factors that prevent accelerating sales growth in the U.S.?
Santosh Shanbhag
ExecutivesYes, I can take that and then maybe Andy and Anders, if you guys want to chime in. And we have said this before, our largest and biggest challenge with growing ACCRUFeR is awareness. It is awareness amongst patients, it's awareness among physicians. I think we're doing a really good job with our sales force in increasing the awareness amongst the top-tier physicians. And our marketing programs are being tested on a daily basis, if not weekly to ensure that we have the right programs to increase awareness amongst both patients as well as physicians. However, to be able to break through the $250 million and get to the $450 million, we need to increase our investments in marketing. And we are being cautious about how we make that happen. We are testing all the marketing programs while we are starting to be cash flow positive. There will be a point in the near future where we are generating enough cash that can be reinvested in our marketing programs to improve awareness. So it's a matter of patience and getting there and being cautious about how we use our dollars towards investments in marketing.
Andrew Hurley
ExecutivesYes, I'll add to that, Santosh. And I agree wholeheartedly. Awareness is our biggest challenge, right? This is a really broad market. We know that there are patients out there seeking answers and solutions to what they're dealing with iron deficiency. Our challenge is based on our spend, how broadly can we actually reach them. And we've done a very good job because ultimately, I mentioned, we've gotten to over 4 million patients and the activity levels with each year are going up. I mentioned 90,000 web searches in March. That's a real example of how well we've been able to optimize marketing within our spend, and we're going to continue to do that to a large degree over the course of the year. We've done that already with sales. We've optimized the sales team and put them into really the biggest high-volume states as much as possible. Have we gotten to the point where we see opportunity for marketing? Absolutely. And that's going to be where we point continually in the future for not only how to optimize our current spend, but an additional investment will only enhance what we've already started here.
Unknown Attendee
AttendeesGreat. Does the business plan to introduce share incentive plans to allow employees to invest in the company?
Anders Lundstrom
ExecutivesSo what we're doing today is that as part of the total remuneration for every employee, they are already receiving shares or share options, I should say. So we're really happy about that because we want everybody to be an owner of this company and be able to sort of really be deeply invested in all the company's performance. So that is what we do. That's what we continue to do, and we don't have any other plans to do anything else at this stage.
Unknown Attendee
AttendeesGreat. Is the war in Iran causing any delays or issues for the manufacturing of ACCRUFeR including any increases in costs?
Anders Lundstrom
ExecutivesNo. There is nothing there. I mean it's, of course, extremely sad with the war going on, but there's nothing in our supply chain from API or manufacturing. All of that happens in Europe today that there's no effect.
Unknown Attendee
AttendeesAre the recently adjusted broker revenue forecast still a realistic goal for this year?
Santosh Shanbhag
ExecutivesWe have never provided revenue guidance or prescription guidance for the year. The brokers build their forecast based on publicly available information and they seem very reasonable to us at this point.
Unknown Attendee
AttendeesHow is Shield Therapeutics using AI to create brand awareness about ACCRUFeR?
Anders Lundstrom
ExecutivesYes, you want to answer that Andy from a marketing point of view?
Andrew Hurley
ExecutivesYes.
Anders Lundstrom
ExecutivesYes, go ahead.
Andrew Hurley
ExecutivesYes. We're continuing to look at AI from a number of different vantage points. Just from a market research perspective, there is just so much data that we can leverage and have, and we'll continue to do so just to understand our customer base better. I think that's been a really big driver when you combine what's available from our own prescription data with the broad understanding beyond that, that's available now with AI. All pharmaceutical companies are just much more equipped to understand the customer better, and we're going to continue to leverage that to align our digital strategies with that knowledge.
Anders Lundstrom
ExecutivesAnd as a sign of being a small company, we are sort of actively introducing AI in every function we have. For us, being on the smaller side, it will be a huge advantage. We will be -- I think every function can be so much more effective, and we are right now in the process of doing so. So I mean, this is really -- it's revolutionary, and I think most people probably use it privately, but I think for a company, especially our size, it's fantastic.
Unknown Attendee
AttendeesAnd from the graph, the drop in sales is actually in December, not the first quarter. Can you explain this, please?
Santosh Shanbhag
ExecutivesYes. So I think this is referencing the weekly data. Andy, do you want me to take that or you can take it then.
Andrew Hurley
ExecutivesYes. So ultimately, December has seen basically the same thing that's happened. It's a month that you see not the amount of selling days to the same degree as other months. I think that's the big thing. Why? Because of holidays, because of vacation time. You just see seasonality in December. And ultimately, that does also lend itself to why we see some softening in Q1 as well because you're coming off the momentum or lack thereof that you sometimes see in December, and that's a lot of what has to do with that. We do realize -- on the positive side, we do realize high deductibles being met or so in December, of course, and that helps us [Technical Difficulty] with some of the other side of December. But ultimately, it's not a new phenomenon of what we've seen in 2025 as seen in previous years as well.
Santosh Shanbhag
ExecutivesYes. And the drop is more prominent in January, right, Andy? Given the insurance resetting on January 1 that is more prominent in January.
Andrew Hurley
ExecutivesThat's correct. That's correct. So ultimately, when you look at Q4 as a whole, you see a very strong month in October, typically equally strong or even better sometimes in November. And there is going to be a softening off of those 2 months. So it looks worse when you look at it across the 3. But Q4, we do well and has and we expect to continue to do so for the reasons I mentioned on high deductibles being met. But yes, you're usually going to see a softening in January and February. We've seen that this year and then rebound in March and all the way through Q2 [ instead ].
Unknown Attendee
AttendeesAnd how does 90,000 ACCRUFeR web searches compared to previous months?
Andrew Hurley
ExecutivesYes, good question. This was our high. We -- all the optimization that we've been doing, and as I mentioned, understanding our customers better, doing more targeting and trying to really figure out who our most valuable consumers are from that demographic understanding. We did roughly around 60,000 web visits in January, a bit more, 65,000 to 70,000 in February and then 90,000 for the month of March. So this is by far our best and really something that we want to continue to look at, at those levels to be able to understand how we can best fit the brand with marketing.
Unknown Attendee
AttendeesAnd what date did prior authorization come into effect for New York?
Andrew Hurley
ExecutivesYes, April 23 of this year. So very recently. And that's the reason for why I say we're still trying to understand a lot of what's happening from a clinical criteria perspective. We know what's published. We know what's been told to us on how to navigate this. But what happens at the physician level is really going to help enable us to understand that better and navigate through it fully and educating offices on exactly how they need to submit prior authorizations to in advance.
Unknown Attendee
AttendeesGreat. Any developments in finding partners in other markets such as LatAm and Middle East?
Anders Lundstrom
ExecutivesThe short answer is yes. And we're currently always looking to see if we can expand geographically. So the short answer is yes. And when it happens, you'll see it, but that's all we can say for now.
Unknown Attendee
AttendeesPerfect. And do you anticipate increasing the sales team numbers during '26 and '27? Or is it currently 80 in total?
Anders Lundstrom
ExecutivesIt is currently roughly 80 in total. We constantly -- I should have Andy also chime into this one. We're constantly looking over where we should place the territories. 80 for the moment is a good number. With increased awareness, this is something that also can increase, of course, because then we will have more physicians. Andy, do you want to add something to the 80.
Andrew Hurley
ExecutivesI think you said. I think that's just a constant effort. For instance, in states like North Carolina, where we've seen some real opportunities, we've actually increased our footprint there because we saw that it was really warranting that. And we're going to continue to do that across all of our big states where we feel like we're maybe undersized where we can actually go and see more lift with just more frequency on our customer base. So that's going to be a constant effort.
Unknown Attendee
AttendeesGreat. Why not simply deploy the $15 million raised for acquisitions on increased marketing to increase growth?
Santosh Shanbhag
ExecutivesYes, that's a great question. And I think it's beyond $15 million. We've got about $27 million of dry powder that sits within our debt structure. And keep in mind, it is debt, so every time we take the money, additional debt that we're adding on the book. So it's really balancing out our needs and managing our debt in the company. The $15 million is earmarked specifically for acquisitions, but we do have some additional money that we can draw on to support our operational needs. And we will take a look at it on a -- we look at it high, high frequency. Do we need the money? How can we not use the money? Do we have to use the money and where are we going to put the money behind and what kind of return on invest do we get for spending that money? So great question. It is really a balanced and disciplined approach to spending the money and the debt.
Unknown Attendee
AttendeesSo despite tshe '23, '24 changes in New York, are you expecting a normal growth overall in Q2?
Santosh Shanbhag
ExecutivesYes. Normal is a very systemic, but then...
Anders Lundstrom
ExecutivesNo, no. As we -- I mean, what we -- what's publicly known is that we see 22% growth over the first 4 weeks in April versus the same period in January of this year, right? So those numbers will continue to be published every week. Exactly how this will play out, it's different, right? And that is very much dependent on the PA criteria, how quickly can we solve for that? We are pivoting. And the good thing is with New York is that it's not -- we are already calling on the commercial part of that business as well because many offices, of course write prescriptions for commercial and Medicaid patients. So while we are pivoting to focus more on the commercial patients, it's not a complete redo of their targets. It's an additional target to what they already have. But that's where we are at. And if something significant were to change during this quarter, we'll announce that because -- but if you hear nothing, it's business as usual.
Unknown Attendee
AttendeesGreat. And when are you planning to formally launch pediatrics and start leveraging the value?
Andrew Hurley
ExecutivesYes, I can take that. So we ended up getting the label expansion, as everyone knows, in December of last year. So what we did with that was we wanted to make sure that our sales force was properly trained. So understanding really all about the new expansion indication, how best to message this to physicians and also try to understand the number of pediatricians and which ones we're going to be actually adding to our target list, which we've since done. So we launched our full launch for the pediatric expansion indication on April 1, and that was across our entire sales team. And keep in mind, all along that time frame, marketing was still in play throughout all of Q1. So pediatricians were able to see this from a marketing perspective. So there was some degree of awareness even before the sales team complemented that effort on April 1. But yes, the official launch to speak to it that way was on April 1 of this year. So we're about a month into the pediatric extension.
Unknown Attendee
AttendeesAnd then on the pediatrics, have you forecast the percentage increase in U.S. sales that pediatric approval will produce?
Santosh Shanbhag
ExecutivesAgain, we haven't provided any guidance on the revenues for 2026 or the future. And like Andy said, it is very early days in terms of the pediatric launch. So even if we were provided, it would be way too early to provide that kind of guidance. Internally, obviously, we have expectations, and we think it is going to be a decent driver of revenue growth for us. Yes.
Unknown Attendee
AttendeesNot a question, but a nice comment that was left was: I'd like to offer my thanks to Santosh for a job well done. You will be missed.
Santosh Shanbhag
ExecutivesThank you. Thank you. To whoever that was, thank you.
Unknown Attendee
AttendeesYes, that kind of rounds up our today's session. Thank you all for your questions. We have many coming in there. And any that we potentially missed we'll follow-up after as well. But yes, thank you on behalf of management at Shield Therapeutics and to everyone attending today's presentation. The recording will be available via the Shield website. And if you have any questions, do share those there. And do you have any kind of closing thoughts, Anders, Santosh or Andy?
Anders Lundstrom
ExecutivesNo, no. Thank you all for taking the time listening to our quarterly update this afternoon. As I said, if there are additional questions that you come up with, please submit them through our website on the Investor part there. We're happy to answer anything you might have thought about after this meeting as well. Thank you all.
Unknown Attendee
AttendeesYes. Thank you and have a lovely afternoon.
Santosh Shanbhag
ExecutivesThank you.
Unknown Attendee
AttendeesThank you.
Andrew Hurley
ExecutivesThank you.
Anders Lundstrom
ExecutivesBye.
Santosh Shanbhag
ExecutivesBye.
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