Good afternoon, good morning, and welcome to the Shield Therapeutics second quarter trading update. My name is Anders Lundstrom, I'm the CEO, and as mentioned, together with me today is Andy Hurley, our Chief Commercial Officer, and Bryon Kallert, our Financial Planning and Analysis Senior Director. We can take the next slide, please. This is our disclaimer. As usual, today's presentation will be available on our website later. Again, we will try to answer all the questions that have come in. For those questions we may not have time to answer, we will provide written answers. Again, we will publish all of that on our website as well. We can go to the next slide. We are Shield Therapeutics. We have one product. It's for iron deficiency and iron deficiency anemia.
It's called Feraccru in the U.K. and Europe, and it's called ACCRUFeR in the U.S. In the U.S. it's the only market where we directly sell and market the product on our own. Iron deficiency is a very large market, and in the U.S. alone, we estimate there is about 14 million patients at any given point. The challenge for many of these patients when they are being treated with an oral iron is that many of the traditional oral irons are dissociated in the stomach and thereby leads to gastrointestinal side effects, which unfortunately then leads to discontinuation of the actual therapy. ACCRUFeR is different and I'll come back to that in just a few seconds. We have very strong IP for ACCRUFeR through 2035, and we estimate that our peak revenues are around $450 million. ACCRUFeR is different, as I said, because of a different formulation.
It makes the product not dissociate in the stomach but rather in the upper intestine. That takes away many of the gastrointestinal related side effects that you could see with traditional oral iron salts. It is absorbed in the upper intestine and the part that is not absorbed continues down the gastrointestinal tract in an undissociated form. Our aim in the U.S. is really to make ACCRUFeR the oral iron of choice, and we have so far seen a great uptake and we continue to see very strong growth. This we will come back to also in a second. We can go to next slide, please. I will then summarize here the key business indicators for the quarter and the first half year.
Bryon will follow me and give you more color to the financial part, and Andy will give you more color on the U.S. commercial business. We posted sales of $10.3 million in the second quarter, which is a 4% increase versus the first quarter of this year, and a 20% decrease versus the same period of last year. The total number of prescription is about 49,000, which is 9% lower than the first quarter of this year, and a slight increase versus the same period of last year. All of this is related to the change we faced with New York Medicaid on April 23rd. What you see in the second quarter is two months of stricter criteria for getting a prior authorization approved in the New York Medicaid situation. What have we done?
We immediately in April pivoted in the sense that we directed our sales force to go after the commercial segment. What do we mean by the commercial segment? Commercial insurance is employer-sponsored insurance, but Medicaid is typically state-supported insurance, but also the federal government subsidizes a part of Medicaid as well. The commercial segment of the market has always been our largest segment. What we see already with this change in focus two months of the three in the second quarter, we see prescription growth. It's 8% versus the first quarter. We see a same period as last year, second quarter this year versus second quarter last year, we see 14% growth. In June alone, we grow about 6% month-over-month. As I said, Andy will come back and break this down even further, what we see in the different states.
The growth is there, the growth is back, and there's a lot of growth still to be had in this marketplace. Changing gears, what do we see from our commercial partners outside the U.S.? In China, we filed for approval earlier this year, and we anticipate an approval in 2027 and a subsequent launch. Same in Korea, where we did receive an approval and are now in the process of applying for price and reimbursement. We anticipate the 2027 commercial launch in Korea. In Canada, by KYE Pharmaceuticals, we've seen really strong sales momentum and the royalties, we have an estimation of royalties from there. We will announce those results when we present the full H1 financials in about a month. We see the same in [Bionorica]. They have grown nicely in volume, and especially that growth comes from the U.K.
I have the next slide, please. It's my great pleasure to introduce to you our new CFO, Michael Jensen, that will join us on September 1st. Michael is a perfect fit for us at Shield and comes with a really strong record as a CFO. We have had several CFO positions from the past, but also have had leading financial positions at very strong and reputable companies as Novo Nordisk, Novartis, and also work in the diagnostics business with Siemens Healthineers. We think Michael will be a key contributor to our executive leadership and will help us steer the company into future success. By that, I give the word and slides over to Bryon.
Thanks, Anders. Next slide, please. We are continuing to focus on three strategic priorities in 2026: growing ACCRUFeR net revenues, driving to achieve profitability, and diversifying our revenue beyond the adult IDA in the United States. For the first half of 2026, we reported $30.4 million, which is a 41% growth over last year. This includes a $7.9 million milestone from our Chinese partner, ASK, a $600,000 pediatric milestone from Norgine, and royalties by Norgine in Europe and KYE in Canada. ACCRUFeR net revenues represent $20.1 million of this in H1 2026, a 5% increase over last year. The revenues were generated by 102,000 total prescriptions at a net price of $199. Second, we are driving to achieve profitability. We reported EBIT profitability in the first half of the year, cash and cash equivalents of $8.3 million as of June 30th, compared to $12.4 million in Q1 2026.
This was driven by a continuous focus on our working capital and cost management. Then third, where we're continuing to focus on diversifying our revenue streams beyond adult IDA in the U.S. We had the Chinese NMPA submission, putting both China and Korea on track for launch in 2027. Our Canadian business is seeing strong growth with double revenue in the first half of the year, and Europe is also seeing double-digit volume growth. Next slide, please. I'll now jump into our quarterly figures. These are the three key metrics that we've been sharing on a consistent basis. Total prescriptions, net selling price per script, and ACCRUFeR net revenues. As you can see on the left side, ACCRUFeR prescriptions in Q2 were approximately 49,000, 28% of which was a consignment business.
The Q2 total prescriptions saw a slight increase compared to Q2 2025. But a slight decline compared to the prior quarter due to the Medicaid prior authorization impact that Anders has discussed earlier in the presentation in New York. The team did pivot to the commercially focused patients in New York to partially offset this loss. Net selling price increased to $208 compared to $190 in Q1. ACCRUFeR net revenues grew 4% to $10.3 million versus Q1. At this point, I'll pass it on to Andy to provide a commercial update.
Thanks, Bryon. My goal today is to talk about what Anders and Bryon have already alluded to, is how are we doing in the first half of the year, taking into account the New York Medicaid situation, talking about what we're doing to pivot to the commercial segment, and how well we've done within that commercial segment. I'll start with an update on how we performed in the first half of the year, which is total prescription growth across the commercial and Medicaid channels. Let's go to the next slide. If you compare the first half of this year to the first half of last year, we had 27% TRx growth in the commercial channel. This is meaningful because the commercial channel represents about two-thirds of our total prescriptions for ACCRUFeR.
When we compare those same time frames within the Medicaid channel, we saw 2% growth. Now, this was largely due to the New York Medicaid change that happened in late April, and that was requiring now going from a no PA situation to a much more tightly controlled process for approving ACCRUFeR prescriptions. I'll talk a little bit more about New York in subsequent slides, but you can see that obviously that did impact our Medicaid business. We saw a really good growth on our commercial segment. When you put the two together, we had a first half of the year that was 17% growth year-over-year, fueled by the commercial channel. Next slide.
When we look at new prescriptions, we saw a 34% increase in commercial new prescriptions comparing first half of last year to first half of this year, but we were flat in Medicaid for the same time frame for the same reason, due to New York Medicaid. When we look at the overall growth of 19% in driving new prescriptions in those time frames year-over-year, this is a healthy number considering the setback that we saw within New York Medicaid. When we look at the second half of the year, we usually see the second half outpacing the first half, as you can see on this chart, and we anticipate the exact same thing happening in 2026. Next slide.
When we break out growth in TRx volume from first half of last year to first half of this year by state, we saw an average of 28% growth across our top six states, and those six states represent about two-thirds of our overall prescription volume nationally. Those states in order of highest volume are Texas, New York, California, Georgia, Florida, and North Carolina. You look at this chart and you see the states from left to right, you can see how much each grew within the commercial and Medicaid channels. For instance, Texas, our largest commercial state, grew its TRx volume by 30% in comparing first half of this year versus first half of last year. I'll get into Texas a bit more just because of how important that state is.
While losing New York Medicaid had significant impact on our overall volume in Q2, the New York commercial business still represented our second biggest state for commercial volume for ACCRUFeR, and our New York commercial volume grew 32% in comparing those two time frames, which is really good. Not only did we see that as a rebound and a pivot once the Medicaid situation came to bear, but we quickly pivoted and was able to really get to that commercial business, which was already discussed. When we look at California, that had our highest commercial growth at 62% year-over-year, first half of the year versus first half of the year, 2026 versus 2025. The three remaining states to the right all had 15% growth or higher, which is fantastic. Next slide. What's driving this prescription growth is a combination of two things.
One, gaining new writers, and secondly, driving depth of prescribing amongst existing prescribers. The sales force has been focused on calling on our highest value targets and growing their ACCRUFeR patient base. From 1H 2025 to 1H 2026, we saw 20% growth in depth of prescribing amongst our highest value targets. This highlights the increased value that providers see ACCRUFeR having for their patients, and also the ability of our sales force to pivot their focus as changes happen in the marketplace. Next slide. As I mentioned, I want to talk about Texas a bit more, as this illustrates how well we've been able to drive commercial business following a change in Medicaid.
Now, we had a very favorable situation in Texas Medicaid as there was no PA for ACCRUFeR for 2023 and 2022 before it, much like what we had in New York for the past three years. Then in Q1 of 2024, the state put a PA in place for ACCRUFeR, and we immediately pivoted to drive our commercial business in Texas. You can see the results on the right. The orange line is our commercial business, and the blue line is our Medicaid business. We were able to pivot our promotional efforts to the commercial channel, and the result was 116% growth for the past two years. This is exactly what we're doing in New York, and we expect big results to follow within the commercial channel in New York and all big states for ACCRUFeR. Next slide.
We have a new opportunity in Texas as we've contracted ACCRUFeR to be available to all McKesson Specialty Oncology clinics. That means over 400 clinics statewide and 700 physicians who will all be new to ACCRUFeR. This partnership with McKesson Specialty now gives those providers discounted access to ACCRUFeR within the McKesson Specialty GPO, and we anticipate this contributing to a strong second half of the year for ACCRUFeR. Next slide. Once again, going back to our big six states, this is showing how well we've grown a prescriber base. You can see that we've had significant growth across every one of our top six states. The states are shown left to right by growth in total prescribers, and above each state is the growth rate from 1H 2025 to 1H 2026.
You can see that New York had the highest number of added prescribers and grew writers by 29%, even with the loss of New York Medicaid in late April of this year. These numbers reflect a focused targeting strategy and doctors continuing to see a difference in ACCRUFeR amongst the other branded and generic iron products. Next slide. Continuing on the topic of growing new writers, this slide shows how we are growing new writers through our digital marketing efforts. Our digital marketing to both HCPs and to patients has grown new writers in a very meaningful way from first half of last year to first half of this year.
This slide shows a monthly breakout with the yellow part of the bars being direct-to-consumer spend and the purple part of the bar being provider spend, and the black line above it represents month-over-month new writer growth. We saw a nice increase in new writer growth in the first half of this year, and we saw much of that increase come from our direct-to-consumer efforts that got patients walking into offices asking for ACCRUFeR. You can see on the right a box that highlights the digital marketing approach that we will be taking in the second half of this year. We plan to have a higher proportion of spend going to consumers based on the high ROI that we've seen from our direct-to-consumer tactics.
We think this should have a direct result in not only driving new writers and prescription growth, but also really getting the providers to feel even more comfortable with more messaging that's coming their way, and patients getting more messaging as the year goes on. I'll wrap it up with this slide that summarizes the key metrics regarding ACCRUFeR performance. In comparing the first half of 2025 to the first half of this year, we saw a 27% increase in total prescription volume, a 34% increase in commercial new prescription volume, and we added approximately 3,200 new writers of ACCRUFeR to our prescriber base. Lastly, we had over 350,000 ACCRUFeR website visits from providers and patients in the first half of this year.
In summary, we're really encouraged by the momentum that we're seeing and having right now, and we anticipate strong performance across our sales and marketing teams in the second half of this year. With that, I'll turn it back over to Anders.
Thank you, Andy. Can we have the next slide, please? In summary, what we tried to share with you this morning is that the iron deficiency market in the U.S. is a very, very large market and with a very significant revenue potential. Yes, we do see growth outside New York Medicaid. What we're trying to explain to you is that there's a lot of prescriptions to be had outside Medicaid in general, and as Andy has explained in great detail, actually the bigger opportunity is in the commercial segment. Just to be clear here, a clinic or a physician can have patients who are insured by Medicaid, Medicare, or commercial.
When we pivot, we still call on some of the same doctors because they cannot have all these patients, but they have also added new target physicians in, to really capitalize on the bigger commercial opportunity. Our global partnerships continue to progress very nicely. Canada has really nice growth, as mentioned by Bryon, and Norgine as well. Norgine has, as we mentioned, double-digit volume growth, and especially in the U.K., where we have had a very nice impact since they started working more with [Zikfunds] in the last couple of years. We have a new CFO. We're very happy about that. Michael is joining us starting September 1st. We continue to drive towards profitability by the end of this year, and we continue to look for productive partnership opportunities to expand the portfolio.
We are basically having the same strategy as we had in the past. We have pivot, and we do see growth coming back as well. That concludes our formal presentation. We are happy to answer all the questions that we've already seen you guys have submitted. We can go to the questions, please.
Perfect.
Yeah.
Sorry, I'm just going to say thank you all for the presentation today. If we start with some of the investor questions that have come through. An IQVIA data showed an all-time high for U.S. ACCRUFeR prescription in Q2 2026, yet the uplift to Shield's reported sales figures was just 5%, well below the usual 25%. How do you explain that gap?
Yeah. The explanation is very simple. It's due to New York Medicaid, where we had seen fantastic growth in that particular segment, that that growth was taken down to a large part by June 23rd. As Andy has explained, we are pivoting, instead focusing on capturing more of the commercial growth. That's what you see, that's what you had. I think we've hopefully been able to show to you that the growth is there, it's just a matter of focus. That we have changed focus, our sales force has been very resilient and have answered what we've asked them to do.
Perfect. Thank you. Does the company have sufficient funding to navigate this commercial reset without returning to market?
Yes. It's a short answer. We continue to invest behind the product as we plan to do this year and in the same fashion as we've done in previous years.
Great. Thank you. Is the company considering adjusting pricing or shifting channel focus, for example, away from Medicaid towards private clinics? If so, why isn't that approach being replicated in other markets?
Well, yes. It's not a private clinic or a public clinic, and that's why I said what I said in my summary, these patients with different type of insurance come into the same clinic, the same prescriber. What we've done historically is always gone after where we have the highest growth potential. The highest growth potential was in Medicaid. As we also have seen, Medicaid is limited to a number of a few states. The commercial access is broader, and you could say in a way it's also more stable because the commercial healthcare, which is then again, employer-sponsored, is not affected by what the federal government does. When the federal government decides to save money It affects the states with Medicaid, and it also affects Medicare, which is actually not an important segment to us.
There's no private and public like you would have in the U.K. or in other parts of Europe.
Thank you, Anders. Are there long-term peak sales targets for ACCRUFeR still realistic? What milestones to maintain confidence in numbers?
Yes, it is. It's still realistic. We have, as I said, we have very solid pattern through 2035, so we have quite a few years still to grow. As we're trying also to explain, this is a very vast market opportunity. We are still the number one prescribed branded oral iron. Having said that, if you look at our market share, it's still relatively low in the market. It's around 4%-5%. There's a lot more to be had. As we continue to invest in the market, as you can see, especially on the marketing side, on the digital side, we keep adding new prescribers. We keep adding patients go to the prescribers and ask for ACCRUFeR. Very importantly, too, is what Andy has shared with you, the number of new prescribers keep increasing.
The depth for those who we focused on, they keep prescribing more. Yes, it's a realistic target.
Great. Thank you. We hear very little about Norgine's commercial performance in the U.K. and E.U., presumably because the contribution is low. Should investors expect similarly modest returns from other markets where Shield doesn't control distribution directly, such as Korea and Canada? If not, what makes these partnerships different?
It makes them different in the way that for Norgine, ACCRUFeR is a relatively small product. They've done some targeted activities, especially in the U.K. They continue to invest in the markets where they are active, U.K., Germany, couple of the Nordic markets, but that is really where they are. It starts to pay off now, even though this is on a small base. Canada is growing very nicely, as I said, we will be able to share those numbers when we do the first half-year update, because then we have the solidified numbers. Korea, again, it would, depending on price, which we do not know yet, price and reimbursement, which we will know next year. Korea is not the largest pharmaceutical market in the world, but it will be a key contributor for us. China, of course, could be potentially a very large market.
It all depends on, in my view, the importance of ACCRUFeR in the portfolio of the company. We make sure when we license out ACCRUFeR to other partners, that it is a key product for them and that would invest behind it subsequently.
Great. Thank you, Anders. When do you expect the South Korean launch, and what milestone payment will Shield receive on that event?
I referred to Bryon. As I said, in 2027, the milestone for the first commercial sale, Bryon, is?
Sorry, I was on mute. Over $1 million.
$1 million, right? That's what it. Yeah.
Perfect. Was the average net price compression to $208 from $231 purely due to New York Medicaid tightened prior authorization requirements?
Bryon?
Yeah, I can take that. Yes, it was. Yeah, to iterate what Anders and Andy have said before, it is related to New York Medicaid tighten. New York Medicaid was the highest value script, so losing some of that volume did put tightened pressure on the actual pricing.
Yeah.
Perfect. Thank you. Can you explain what the GPO will add to subscriptions per quarter?
Andy? Oops.
I think Andy lost power.
Power went out.
Here's Andy. He's in another room now. Go ahead, Andy. GPO, what does it mean? Maybe you can also explain sort of in-hospital, outside hospital, whole dynamics of that.
Sure. Yeah. The GPO allows for us to have a discounted price for inside clinic sales. Typically, we are leveraging retail pharmacies in the normal environment. A prescription gets filled in an office-based environment, it goes into a retail door. With this, they are filled inside the GPO, I'm sorry, inside the oncology clinic through the GPO contract. They can purchase right from McKesson. The McKesson distribution will go right into their inner pharmacy. Then we establish this new channel by virtue of having this inside sales that's occurring that we did not have before. That's really a new channel in itself.
Really it becomes big because of the fact that this becomes an opportunity for us to see physicians that we're not typically seeing, that haven't been on our target list in the past, and that have incredible opportunity because within the hematology and oncology side, there is a huge need for a good option, a therapeutic option for an oral iron, which ACCRUFeR is. We've already, in limited time in talking to folks, we've already seen a great reception for the product. We anticipate it's going to be really well-received and add to our sales in the second half of the year and beyond.
Great. Thank you, Andy.
Back up and running.
Sorry. Despite increased prescriptions, when and how do you expect to start making a significant dent in your potential customer base?
I didn't get that. Can you repeat that? You're breaking up a little.
I'm sorry. Despite increased prescriptions, when and how do you expect to start making a significant dent in your potential customer base?
Well, I think from a perspective of what I mentioned in my slides is we put a real concerted effort, and we'll be doing even more so in the second half of the year, of reaching patients. Going to the patient dynamic, they're walking in asking for ACCRUFeR. We can scale the marketing side of our business exponentially by going out universally across the entire country. We're going to be focused on our bigger states where we have a lot of our providers and our targets. I think we're already making efforts to be putting a dent in our overall prescriber base.
It's not just by targeting the prescribers themselves through sales force efforts, it's a combination of sales and marketing efforts that's also touching the patient side of our business that I think is really coming together quite nicely and will continue to expand our overall business.
Great. Thank you. How many states are you now selling in? Will you sell in every state in time?
Yeah. We look for areas of concentration across the country that overlaps with what we mentioned before, our commercial payer coverage, which is very good. We match those two things up and try to see where the biggest opportunity is. We are covering, either through sales or marketing, every state in the country, but we put our sales force into areas where there's the greatest opportunity for pull-through of our business.
Amazing. The current H1 revenue is $3 0 million. What is your anticipation of H2 revenue, and will the whole year still stay cash positive?
We never commented previously on what outlook would be for the second half year. We've stated today, yes, we are driving towards profitability for the year. We stick to that for now.
Great. I think that is all our questions here today so far. Thank you all, Bryon, Andy, and Anders for answering all those investor questions. Before we finish off today, do you have any closing comments before we finish off?
Yeah. Thank you. Yeah, I hope we've been able to explain a little bit more about the U.S. market dynamics. I do understand they differ significantly from most countries in Europe. It is a very special market in the way that there are different types of insurance depending on who you are and what age you are and if you're employed or not and so forth. If there are further questions around this, please submit them on our website. We're happy to try to explain it as much as we can. The U.S. market is more dynamic both ways, up and down sometimes, but the market is what it is. I hope we were able to explain to you as well that there is a lot of growth still to be had.
We have a good trajectory in our new focus, which are our commercial business, which we've seen over the last two months of the second quarter. As I said, if you need more explanations, I'm happy to provide that so you can understand really what the dynamics are and how they affect ACCRUFeR as a product. Thank you so much for all your thoughtful questions. It's been a pleasure to communicate with you this afternoon.
Thanks again to your team for updating investors today. On behalf of the management team at Shield Therapeutics, thank you for attending today's presentation. The recording will be available via the Shield Therapeutics website. If you have any other questions, please do share those with us and we'll get back to you shortly. Have a good afternoon, and good morning to those in the U.S.
Thank you.
Thank you, everybody.
Thank you.
Bye bye everybody. Bye.