Good afternoon and welcome to the Shield Therapeutics PLC Q2 trading update. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and they can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll. I would now like to hand you over to the management team of Shield Therapeutics, Anders Lundstrom. Santosh, good afternoon.
Good afternoon, Alex, and thank you for the introduction. Good afternoon, everybody. If you happen to be on the U.S. continent, good morning. My name is Anders Lundstrom. I'm the CEO of Shield Therapeutics. Together with me this morning is Santosh Shanbhag, who is our CFO. We together will walk you through the quarter two presentation and also the Q&A following the actual presentation. Here's the disclaimer. I'm not going to give you much time to read it, but there it was. We'll jump straight into it. I will start by describing the company, Shield Therapeutics, our product, and the market. Iron deficiency is a very large market. In the U.S. alone, there's about 15 million individuals every year that have iron deficiency with or without anemia. The typical treatment for iron deficiency is ferrous sulfate, an oral treatment.
The challenge here is that about 40% - 60% of patients cannot tolerate that treatment. ACCRUFeR is the brand name in the U.S., and Feraccru, typically the brand name outside the U.S., is a different type of formulation. I will describe that better in a couple of slides. In short, it does not have the same tolerability profile as the oral ferrous sulfate has. The treatment is better tolerated and has a better efficacy. It's approved here in the U.S., in Europe, in the U.K., in Switzerland, and in Canada. I'll also come back to what the status is for the other markets across the world where we have partnerships. Our peak revenue of ACCRUFeR is estimated to be around $415 million yearly. We have very strong intellectual property protection through 2035.
The big goal for us this year is to turn cash flow positive towards the end of the year. We have a very experienced executive team with extensive U.S. commercialization expertise across all disciplines needed to be able to launch a product and sustain a product in the U.S. and across the world. David and Jackie are located in our Newcastle head offices. The rest of us are in our office just outside Boston. As I started to explain a couple of slides ago, the typical treatment for iron deficiency is an oral ferrous sulfate. The challenge with these types of products is that it dissociates in the stomach. The iron by itself causes irritation. This irritation can in turn then turn into gastrointestinal-related side effects like bloating, dark stool, nausea, and so forth. Up to seven out of 10 patients can experience these side effects.
Almost 60% of those patients, so about half of the patients in total, will discontinue treatment due to the side effects. Of course, if you discontinue treatment, you will not have any effect of your treatment. ACCRUFeR is different. It's different in that we're not a salt. We have a maltose shield covering the actual iron molecule. It does not dissociate in the stomach. It actually dissociates in the upper intestine where it's absorbed. By that, we actually avoid many of those gastrointestinal side effects, giving the patient a better experience because we have a better tolerability profile. They can stay on therapy as long as it is needed. Typically, about 90% of oral irons are salts. Before ACCRUFeR, there was sort of no other way of getting iron. If you couldn't tolerate a salt, you needed iron, you needed an IV infusion.
ACCRUFeR fills a very important place in this market where we can now be the oral alternative to patients that do not tolerate an oral ferrous sulfate. This is where we are. This is where our position is. This is why we see the increase in prescriptions and so forth continuously because of so many patients that need iron. Changing gears here, to talk about our partnership across the world. At your left in the U.S., we have a collaboration with Viatris. It's a 50/50 collaboration. We have 40 sets each, so a total of 80. I'll come back to the U.S. in a little bit. In Europe, Norgine is our partner. The update here is we just received a milestone from them when we had the acceptance of our pediatric file that was filed a couple of months ago. We got half of that milestone now.
In Canada, KYE has launched. They are in the process of securing coverage with their payers. We'll see more and more from Canada towards the second half of this year. In Korea, we are expecting an approval sometime probably in the second half of this year. In China, as we communicated earlier, our phase III study is completed. We expect them to file during this quarter. The news here is that in Japan, we found a partner. We signed a deal in April. We also got a small milestone for that. That came to us during this quarter. Back to the U.S. In the U.S., there's about 15 million adults with iron deficiency or iron deficiency with anemia. The smaller circle, the orange smaller circle, is where we have our sales force. They cover about 10,000 prescribers. Our focus is primary care and women's health.
This is a market opportunity of about 250,000 patients because that's half of the half a million patients that take oral iron. As I said earlier, about 50% of those cannot tolerate the ferrous sulfate. The lighter blue circle is what we initiated last year. We initiated marketing different forms of digital marketing. I'll describe them in a couple of slides, both to healthcare professionals and direct to consumers, patients. This lighter blue circle is about 50,000 healthcare professionals. Here we go broader than primary care and women's health. We also target nephrology, hematology, and gastroenterology. This is about 1.3 million patients that have side effects from the oral iron salts. This year, we broadened this even further. As you can see, the darker blue circle, we do direct to consumer, direct to patient marketing, of course, within our indication. We've gone broader.
Now we target people, patients who are seeking oral iron treatment online. As I said, I describe some of those activities in the subsequent slide. This is where we have focused our digital marketing efforts. On the physician side or prescriber side, we have a sampling program. Prescribers can order samples directly online. We have something that is called electronic health record banner marketing. If a prescriber is about to prescribe an oral iron, there's a banner served to that prescriber describing ACCRUFeR. We also do a lot of digital advertising through different channels. As you can see, there are big numbers when it comes to impressions. That banner marketing is over 9 million. There's 14 million impressions on digital advertising. A lot of eyes on ACCRUFeR. We're doing this to drive awareness. On the patient side, we have influencers, Instagram influencers.
We have three of them, and we are in the process of increasing that to eight. We do a lot of social media advertising here as well. As you can see, again, we get a lot of impressions, a lot of eyes on ACCRUFeR. What does it really mean? Does it have an impact? We can measure that by looking at how many new prescribers we can see every month. This graph shows the impression in the bars and the number of new writers on the lines. The dark blue part of the bar is what the sales force is doing. That's the number of visits. The purplish is the number of impressions that prescribers have seen. The yellow is the number of impressions for consumers or patients.
As you can see from the lines, we measure new writers because that's the purest way for us to see when a physician writes for the first time. The blue line describes that we have about 500 new writers in June, if you take the month of June as an example. In addition to that, thanks to our digital marketing efforts, we get an additional 300 new writers. Yes, it works. It works really well via digital marketing, even though, of course, our main source for getting new writers is still from the field force. It could very well be that we could get as many new writers from digital marketing as we get from the field force. The good thing with that is, of course, when we get a new writer, that information is passed on to the field force so they can continue to detail that customer.
What have the key initiatives been that built the momentum and the results we've seen in the second quarter? I just described to you our increased awareness of ACCRUFeR. These were the marketing initiatives that we have increased this year. The other part that is very important for this year is that we optimize the sales force territories, where we focus on territories where we historically have had the highest ACCRUFeR sales, the best coverage from insurance, and the best access to see these physicians. We have 80 now fully staffed territories, which was not the case in the beginning of the year, but we're fully staffed now. It's a rather concentrated market, which is kind of interesting to see. We have six states that stand for about two-thirds of all prescriptions.
The last piece, which is very important and is more downstream work, is to increase the number of prior authorization, which means for a physician to be able to prescribe and for the patient to be able to receive ACCRUFeR, you would need to fill in a form to show that they cannot tolerate an oral iron salt. Typically, with that, it would be approved by the payer and the patient can get the product. We work on getting the number of submissions up, the approval rate up, so we can get the coverage fill rate up. Here, we work with pharmacies that can help the offices, the prescribers, to deal with the prior approval process.
The last piece here, which is also important, is to leverage case managers to actually contact patients to pick up unfilled prescriptions because, surprisingly, quite a few patients where everything is approved, they don't answer on the phone, they don't answer text messages, and you keep the reminder over and over again that you actually can go and pick up that prescription, which is, of course, very important as well for everybody involved. By that, I will leave over to Santosh. Please, Santosh.
Thank you, Anders. Hello, everyone. Excited to report our Q2 update. As many of you have seen, the business priorities for 2025 are growing ACCRUFeR net revenues, especially in the United States, turning cash flow positive by the end of 2025, and expanding globally, whether it's Canada, Korea, China, the pediatric population, or recently in Japan, like Anders mentioned.
We are excited that we are making significant progress on all of these key priorities. As you can see, in Q2 2025, we reported $12.8 million in ACCRUFeR net revenues. That is double what we did in Q1 2025 of $6.4 million. This was obviously through both prescription growth as well as pricing growth. We reported approximately 47,000 prescriptions, which is the highest quarter we have ever had since launch. That's a 30% growth over Q1 2025, with strong net selling prices as well, $231 net selling price in Q2 2025 compared to $187 in Q1 2025. Across these three key metrics, we are excited about the momentum that we are continuing to see build in Q2, and we believe this translates really nicely into helping us execute the second half of 2025 as well.
Turning to cash and cash flow positive, we reported $10.8 million Q2 ending cash and cash equivalents. As you can see, that's a growth compared to Q1, where we reported $10.5 million. Keep in mind, these are one-off events that took place in Q2. As Anders mentioned, we did receive $665,000 from Vitalnet in support of the Japanese licensing agreement, as well as EUR 500,000 from Norgine supporting the EMA regulatory process. We are on track, and we are excited to report that we are continuing to reiterate our guidance of turning cash flow positive by the end of 2025. Last but not least, from a global perspective, like Anders said and I just mentioned, we did file our pediatric label expansion both with the EMA and FDA. In support of the EMA filing, we did receive EUR 500,000 in milestone payments from Norgine.
We did expand our global presence through our partnership with Vitalnet in Japan. Again, $665,000 payment that was an upfront, plus we expect regulatory and sales milestones with double-digit royalties on net sales. A strong quarter. Digging in a little bit deeper, this slide represents the weekly prescriptions for ACCRUFeR in the United States. You can see the clear growth. There are ups and downs, as you can imagine, in any launch. However, the direction of travel is important here. You can see there is significant growth since the early days of launch, and especially after we established the partnership with Viatris in early 2023. We did end the quarter in Q2 with the highest prescription for a given week. You can see it was close to north of 4,000 prescriptions per week. The performance here is strong. The momentum here is strong.
We feel pretty excited about what this means for the second half of 2025. Digging into some of these key metrics, like I said, ACCRUFeR net revenue is $12.8 million. Growth is strong. We expect that to continue to grow into the second half of 2025. Net price per script, we've always seen ups and downs through this. As long as it's moving to the top and right, that's what matters. We reported $231 net price per script here in Q2 2025. Total prescriptions, 47,000 prescriptions, of which about 36,000 were actually retail. The remaining were consignment. Keep in mind, consignment is a business that is being delivered to the patients free of cost or at a significantly subsidized price while we wait for reimbursement by payers. The idea here is to keep that gray bar, which represents consignment, as small as possible.
We do believe that is an important part of the business driver because those gray bars typically convert into blue bars in the following quarters. Moving on to some of the details, as Anders mentioned, six states typically drive the growth of ACCRUFeR. We are excited about that because it does bring some diversity. As people who have followed Shield in the past, we were concentrated on one or two states. It is good to see that we are now across multiple states and multiple states are driving the business. On the left-hand side of this chart, you can see the prescriptions by channel. Clearly, commercial is the largest portion of our business. 44% of our business comes from the commercial channel. 28% comes from Medicaid. As I had said in the past, 25% comes from consignment.
The idea would be to continue to make that part of the pie chart smaller while we grow the orange and the dark blue parts. There is 3% other. Within Medicaid, about 85% of our prescriptions come through Texas, New York, Florida, Georgia, California, and North Carolina. A large portion of our business comes from those six states within Medicaid. Very similar story in commercial as well. About 65% comes from those six states. Overall, a healthy business. Revenue is growing. Prescriptions are growing. Price is growing. We continue to diversify into the large states within the United States. With that, I'll hand it back to Anders. We move to questions.
If I unmute, we will also hear. Thank you, Santosh. Just in summary, the iron deficiency market globally is a huge significant opportunity for us in the United States specifically, of course, as we have described.
Our partnership with Viatris continues to drive growth for ACCRUFeR and as Santosh just described. We are only two years in. If you actually look carefully on Santosh, we have only had two years with a full sales force. It's really only this year we actually stepped up our digital marketing efforts to prescribers and to consumers or patients. As I also described, our global partnerships continue to progress as anticipated almost. We have more to receive there when it comes to milestones and double-digit royalties. Just for clarity's sake, with Norgine on the slide, my slide said it was half a million. It was EUR 1 million total for the pediatric filing. Half is when the file was accepted. The other half will come when the actual indication is approved. Our goal is to be cash flow positive by the end of this year.
In addition, we're also looking for partnership opportunities so we can continue to expand our portfolio and continue to grow this business. That concludes the formal part of the presentation. We can move into questions and answers.
Fantastic, Anders, Santosh. Thank you very much indeed for your presentation. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the top right corner of your screen. While the company takes a few moments to review those questions submitted today, I would like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via your vested dashboard. Anders, Santosh, as you can see, we have received a number of questions throughout today's presentation. Stephanie, if I may now hand back to you to chair the Q&A. I'll pick up from you at the end. Thank you.
Thank you. Thank you, Anders. Thank you, Santosh. First question, you talked about social media. How much does the company rely on patients independently telling their friends that ACCRUFeR works for them and using caution like social media and self-help groups to inform others?
It is happening to an increased extent almost every day. This really bigger push directly to patients started in the beginning of this year. It has taken a few months, as you saw on the slide, to get into good momentum. We continue to increase, for instance, the number of Instagram influencers. We are about to launch patient stories as well, patient testimonials. We will actually share one with you as we conclude this call. It is an important part when it comes to drive new prescribers. It is also an important part where we also, as shown, can go a little bit outside our core target groups to have patients go to those physicians and ask for ACCRUFeR as well.
If we, as of June, can get 300 out of 800 new prescribers directly from these types of activities, we expect that to continue to increase. There are so many numbers to throw around. It is kind of amazing in how many chat forums and other fora that iron deficiency is actually discussed. What we have done with our latest push is to identify where these people actually are. Instead of just going after those who had a bad experience with another oral salt, as we said, we expanded that to people who are actively looking for treatment. It is quite a few. How far this can go is very hard to tell, but it has a positive impact on the prescribing of ACCRUFeR for sure.
Thank you. Also, could you remind us about once the patient becomes a patient, is that patient then long-term?
We actually have, we didn't share data about that. We have followed cohorts of patients that have started to use ACCRUFeR as a direct result of digital marketing. The short answer is yes. They continue to use it. Keep in mind, for most patients, ACCRUFeR is not a chronic therapy. They typically stay on therapy for somewhere between three to four months. If they need it again, yes, we see that too. When we have that data a little bit clearer, it's something we plan to share at our next quarterly update. The short answer is yes, we see that.
Thank you. Are we expecting prescription numbers to grow and to continue to grow into Q3?
Santosh, I think that's for you. You're the numbers guy here.
Absolutely. Absolutely. I think our intent is for prescriptions to grow and align with pricing and revenue. Like Anders said, you know, we're still in the early days of launch. You should expect to see growth over the quarters. There may be some quarters where the growth is not as high as the others just because of the way the market dynamics work. You should expect to see growth over the quarters and years.
Yeah. If I may add to that, as Santosh also earlier said, now we know we show a slide, not that long, but on the slide where you had the prescriptions, you see the momentum, right? We said it already in the first quarter. We exited the first quarter with a very good momentum, meaning that the number of prescriptions per week, as we measure it, continues to go up. Same thing here, end of June, highest ever. That is why we expect to see continued growth. To Santosh's point, what the number will be, it's very hard to tell, right? We have very good momentum in our business. We've seen that since actually the beginning, mid or March of this year, when we were almost fully staffed and when these digital activities started to kick in.
Thank you. What types of partnership opportunities are being targeted to expand the portfolio?
In short, we're pretty agnostic, actually. The reason for saying that is that we've almost soon shown that you can go, you know, start making money with being a one-product company. It's actually not the ideal to have a whole organization relying on one product. ACCRUFeR by itself, as described on one of the slides, has quite a few different types of prescribers. Now we focus on primary care. We focus on women's health. We also started to focus more on nephrology, hematology, oncology, gastroenterology. We can look for products in very many different therapy areas that will be complementary to ACCRUFeR itself. That's number one. Number two, I would say we could go to different areas as well. I think we've shown that we are able to take a product, commercialize it.
As we said, we do believe still that we are able to go break even in the end of this year. The hard part really here is to set everything up, make sure everything works, get everything in place. What I mean by that, having a sales force, having marketing, having commercial operations, having commercial analytics, and all other things, regulatory, manufacturing, all of these things you need to sort of medical to be a sort of fully integrated company. If you've done it once, you can do it twice. You can do it three times. You can do it four times because we have this very strong organization and a very strong backbone. Anything you want to add, Santosh, there?
Oh, sure, Anders. I mean, I think this goes without saying, I guess, but our number one priority is ACCRUFeR. ACCRUFeR is where we are going to spend all of our energy, time to make sure that it grows and continues to meet its potential of $450 million. That's the objective. I think number two is, to Anders' point, I think we've got an amazing infrastructure that can help commercialize the second product. What that also means is we will be looking for products that are commercial in nature. We're not looking for phase IIs, phase Is. We don't have the resources to be able to push that all the way through commercialization. We'd most likely look for something in a phase III or an FDA-approved product to help support, to help leverage the infrastructure that we have that Anders just talked about.
Thank you. Are you still currently recruiting a new sales force, or is this now being completed?
It is more or less complete. I think we're almost complete. It could be we need one more. It's basically, we're basically done, which, of course, has a huge impact on the results we see compared to the beginning of the year when we were looking for a number of new positions to fill the sales force. We're basically done. Unfortunately, as soon as you say done, you probably would need someone who leaves. It's typically the nature. We're more or less fully staffed.
Thank you. One question is, how much further headroom do you think there still exists above the $231 net selling price?
Yeah. I mean, I think there is enough headroom. If you look at the ups and downs of pricing, there are so many factors that bleed into it. You know, what percent of our channels was commercial, what percent was Medicaid, what percent was consignment. As we have said before, we want to reduce the consignment channel. That will only help increase the price. However, when we go on the commercial side, the more contracts and rebates that we have, that can have an impact on price. Overall, I think high level, I think there is more room to grow on the pricing. There is, I think at some point in the past, we have said, you know, we like to get to somewhere around the $250 range. I think that's a good marker for us. It's going to be tough, I think, to get there quickly.
I think there is room to get there. Hopefully, that helps address that question.
Thank you. Somebody's also asked as well if you can expand on what the current market for iron is, oral iron and IV iron in the U.S. and globally.
I mean, the IV iron market, to be perfectly clear, we don't follow that one. There's nothing we can really do there. If somebody needs an IV iron, we cannot be a substitute to that. We can be a follow-on to a patient that has received an IV iron to keep for that patient to continue to have a good level of iron in the body. As one of these slides shows, still over 90% of huge iron use is in salts, oral iron salts of the prescribed market. I should know, but there's still a lot of room. I don't, I mean, our market share in the prescribed market, we still, we're not, maybe we have a third. I don't think, Santosh, I might, yeah, do you have the number of the prescribed market? I know we have a slide on that somewhere.
Yeah. I think, what was it? We have about 15 million patients in the United States. Yeah, that's the overall market. I believe that that sums it to about 20 million- 25 million in total prescriptions. I mean, the U.S. is the largest driver of the business in the space specifically for us. We do have China that's pretty large, just given the population.
Yeah, of course.
U.S. is the largest driver for us in terms of market opportunity.
Thank you. How concerned are you regarding pending tariffs?
You want me to take that, Anders?
Yeah, please do. Yeah.
Yeah. I think the short answer is not very concerned. Let me give you a slightly longer answer. I think as we have all been following the tariff situation, it is pretty volatile. Trying to build out a strategy or a tactic, given the volatility, does not make sense right now. Number two is we have built up a decent amount of inventory just to run the business, just running business operations. We are in a favorable position there where we do not really have to make quick decisions right now because we do have a decent amount of inventory sitting here in the United States. We will continue to bring more product in to support the business. It is not going to be a significant impact to us. Obviously, number three, I think it is important to note that we bring our products in at cost.
This really is not a revenue issue. It is more of a gross margin issue. Given our costs, I am not too concerned about what that means as an impact to our gross margins either. We will keep a close eye on it. Right now, we are not doing anything as a company to address the tariff situation because honestly, it does not really impact the business a lot. However, we will keep a close eye on it. If it starts to have a larger impact, then we will start taking action. Right now, the issue is not a big one for us, right?
Thanks. I note that 10 new iron sales staff joined in Q1 2025 with another seven sales staff in Q2 2025. Are you now looking at increasing the sales staff beyond the stated limit now that sales are increasing?
To be very clear, there's 80 salespeople in total between us and Viatris. That's the number we should look at. That's the number we'll keep at least for this year. If we continue to see growth, we might change that and go back to having 100 people again. For now, we'll stick with 80. 80 is the number, 40 per company.
Thank you. You've also mentioned about the pediatric program. Can you share some more information on this program and the potential?
We're looking very closely into that. It's two parts, you can say, of the pediatric population. One is patients over the age of 10, or basically anyone who could swallow a capsule, they would use the current product. The younger people, from a newborn to a baby to a toddler, here we need to bring the suspension to the market for them to be able to use the product. We are starting to look into what the market opportunity is. Anecdotally, if you speak to the pediatric nephrologists, they see a big need, and other pediatric subspecialties that deal with patients that have iron deficiency. We believe there could be quite a big need there as well. For instance, children with ADHD, a third of them have iron deficiency because they don't eat properly. This might be a bigger opportunity than we anticipated from the beginning.
In the U.S., we're doing the market preparation work right now. In Europe, Norgine is doing the same thing.
Thank you. Somebody just asked on the back of the sales questions, can you remind us why we actually reduced the sales force from 100 to 28?
We did that looking at all the territories we had last year. If we were to concentrate it, making them slightly larger, and looking, by the end of last year, as you've seen from one of the slides, we had about 18 months of data. Before that, we didn't really have good background data about where ACCRUFeR sales system, where was the best ACCRUFeR sales, where did we have the best payer coverage, and where we had access to actually speak to our customers. We came to the conclusion that in about 20 of those territories, we didn't make any money. We didn't even make the salary of a salesperson. With the financial situation we had towards the end of last year, this was a necessity to go down to 80.
It turns out, with the $10 million investment we got from AUP, we could have gone back up to 100. What we instead did, we stuck to, and this was a consultation with Viatris, we stuck to 80, which was about 80 top-performing territories, and increased the investment in digital marketing instead. As we've shown, we believe this is a better mix of having the number of territories and the money we can now spend in digital marketing. As I said, as we continue to grow and as we can continue to get new prescribers, this is something we'll be revisiting by towards the end of this year. With even more data, other places where we would benefit from having more territories. Here again, with digital marketing, this can lead us to new territories back to a number again, whatever that number would be together with Viatris.
If you just look at market penetration, which we tried to answer earlier, we're still scraping the surface of this market. There's so much more we could do. We need the financial strength to be able to invest even more behind sales and marketing.
Thank you. What is the confidence level based on the current trajectory that Shield will be cash flow positive by the end of 2025?
Question for the CFO.
I haven't the confidence interval, I haven't run any statistical analysis. I think you should take away that we have a high level of confidence, given that we just reiterated our guidance on turning cash flow positive by the end of 2025.
Thank you. Somebody's asking as well, would it be possible to understand the trends in repeat prescriptions?
As I said, sorry, we can't sort of have a live conversation here. It depends on what you, there's so many different ways to repeat prescriptions. Let me tackle, I always describe that one patient typically is on for three to four months. That's one way. If the question now is more, oh, but is that now, is that prescriber then keep prescribing the product for other patients? Let me tackle that part then. Yes, we see that. Every territory, every salesperson has a top 25 list of customers that they focus more on than the rest of their customers in that territory. What we are driving towards, even though I showed the slide with new prescribers, we're driving towards that. If somebody starts prescribing, they are very likely to continue to prescribe because we know the product works really, the product works really, really well.
Yes, this is a very strong focus on getting our top prescribers to prescribe more. This top 25 list we have per territory is also updated every quarter. We keep going after the top 25 highest prescribers. When I say highest prescribers, we also take into account what the potential is for each of those top 25 prescribers. If that is the repeat prescription question angle, yes, we do that. If it is per patient, it's very different, it's a different question. Actually, we now have data because we just purchased claims data. We can see the history of a patient as well now. We are analyzing that type of data. If a patient, we can see what was the journey, where did they start, how did they continue, and so forth.
We should be able to get you a better answer on a per patient and on the per patient angle when we have this call in three months.
Thank you. We've got 47,000 prescriptions at $231 is $10.8 million. We've reported $12.8 million. Is this adding inventory ahead of the July 4th holidays?
This is a great question. It seems to come up almost every quarter. Keep in mind, there's a prescription, which is the prescriptions that we know that patients picked up. These are dispensed prescriptions. When we recognize revenue, we recognize it based on the sale of a title to our wholesalers. The revenue is linked to the sale to the wholesalers or a shift of a title from Shield to the wholesalers, while the prescription is downstream from there, which is from the wholesalers to the pharmacy to the patient. We report the prescription as a dispensed prescription to the patient, which is why you would see the disconnect. I would not divide the prescription or the revenue divided by the prescription to get the price because that's not the right math when we look at revenue.
To the question specifically about inventory buildup, there is potentially a little bit of a buildup ahead of July 4th. Those who have followed us for a while, you probably heard us say something similar last year as well. We see that trend pretty much all the time. It's not a significant amount, but a decent amount because July 4th is the week where a lot of people take off and are just planning for that week. It just so happens that it's a cusp between Q2 and Q3. We saw a little bit of that. We may see an impact of that in Q3. We'll keep an eye on that. It should not significantly change the trajectory of the growth.
Thank you. Can you also discuss what progress Norgine is making within Europe?
Yeah, absolutely. Norgine, the focus markets for Norgine in Europe are first and foremost Germany. They continue to see growth in Germany. They also changed their business model slightly. They are now using the digital channels more than before. Of course, the big difference between the U.S. and Europe is that you cannot go directly to patients. They've been successful doing that, with digital activities directly to the prescribers. In the U.K., you see the same thing. It's slightly smaller than Germany. We continue to see very, very, very strong growth in the U.K. as well. Also in the Nordic countries, predominantly Sweden. I believe it's Norway or Denmark, but Sweden is the main market there. Those are the main markets for Norgine. We continue to see growth. We typically haven't commented on the milestone revenue in this update.
That will come in when we give you an update on the first half's financials in a few weeks, in a month, Santosh. I don't know exactly when we're ready. Then we will share also how they are performing and what our royalty revenues are from Norgine. We can give you more details.
Thank you. Can you please explain as well how revenues and cost of sales that are generated by the Viatris team are reflected in Shield's accounts?
Oh, yeah, sure. I can take that. It's pretty simple. The revenue that we recognize on our P&L reflects the revenue associated with ACCRUFeR in total. That's the total revenue that gets recognized. Whether it's Viatris or Shield, it gets recognized on our top line as net revenue. The share, the 45% that we need to pay Viatris because that's the share of their revenue, gets booked as cost of revenue. It'll hit your cost of revenue, and you'll see that there. It's pretty straightforward. Total revenue on our top line and the cost of revenue is where Viatris takes their share.
Thank you. I've got one question here. Given the large population, are you considering expanding to India in the future?
That has been on the table. We don't have any company that shows really strong interest for India as of yet. We are looking into other geographies, though, Middle East, North, South Africa, Latin America, where we do have quite a lot of interest to take the product there. It all comes down to pricing, actually. If we have a company that will be interested in bringing our product to India, there's a business case that makes sense for them. Yeah, we will, of course, be interested in doing that.
Thank you. Please, can you provide some more information on the relationship that you have with Viatris? You mentioned earlier that they were pleased with progress.
The relationship is in the way that we have a sales force that we have 40 reps. They have 40 reps. Santosh just described the overall economics. It's a 55-45 split. We are responsible for marketing, medical training. They are helping us a lot with getting payer access. They have a very experienced and strong team to do that. That's basically how it works. It's governed by the joint committee. We meet every three months. Of course, there's many, many more meetings on the commercial sales and marketing side between the two companies as well because it's a true collaboration across every function. Even though we have some responsibilities and they have other responsibilities, it's still a true collaboration between the two companies.
Thank you. When can we expect pediatric approval to be received?
In the EU, I would say sometime early next year, for sure the first half of next year. U.S. is a half step behind. We have submitted, but it will take us another six, seven, eight weeks before we know if the file is approved and confirmed. We passed that step in Europe, and that's why we received the milestone.
Thank you. Q2 shows some strong growth. How do we get from $40 to $50 million of annual sales to $450 million annual sales?
By continuing to grow the product, it's a great question, right? There are a couple of things you can look at there. One is, of course, how much time do we have in the market? As we mentioned initially, we have very strong intellectual property protection through 2035, which is another 10 years. Knock on wood that we don't have any generic filers, which we don't have as of sitting here right now. That's one. Two is, as we described before, it's an enormous market. It's super big. If we can continue to grow as we do and continue to grow into other specialties as we do now on the marketing side, and then next level we continue to build out the sales force, that's the way to get there. That is how we model it.
If we actually get there, you probably would be rather surprised on the not so aggressive yearly growth you would need to see until the early 2030 years. You actually see that you actually can get to that number. It's not a number we sort of put out of our hat, and it sounds like a good number. There's a very robust model behind that. With the growth we've had historically over the last few years, that is what we can use and that is how Santosh and the input from, of course, other commercial people who are very close to the market, how we get to that number. Santosh, do you want to add anything more precise methodology-wise onto that?
Oh, I think he's just frozen.
Oh, frozen. Okay.
Yes, let me just bring him back in.
He'll rejoin.
Yeah.
He looked stunned. I don't think the question stunned him. I don't know that. Here we go.
Perfect. Santosh, you are back.
Am I back? I don't know what happened there. Sorry.
I don't know either. I said the main video, you were stunned by the question, but I don't think so. I just asked you if you could put some more light in how we get to the 450 for sure.
Yeah, yeah. No, I mean, keep in mind, we are early days. Our penetration in the market is low single digits. It is really, really small. Our biggest challenge right now is awareness, right? Our product is clean. I think the physicians who write it seem to like it a lot. Patients who use it, they seem to like it a lot. Our problem is awareness. I think the programs that Anders just alluded to earlier part of the presentation, where marketing is going to be an important lever to help us get there, I think that's going to be the key driver. Of course, our sales force being more efficient. Marketing is going to be the key driver. I think that's what we need to do to help get to the 450. Awareness specifically for marketing.
Yeah.
Thank you. In Q1, you reported 27% consignment-based prescriptions. In Q2, you've reported 23% consignment-based prescriptions. Can you explain the impact on these consignment-based prescriptions and what they have had on revenues announced so far?
Yeah, go ahead, Santosh.
You started explaining it before, when the impact happens and so forth.
Yeah, yeah. Consignment is kind of a double-edged sword for us. There's a part of it which is because we give it for free or extremely low price, it either has a zero revenue impact or sometimes a negative revenue impact because the net revenue is actually lower than zero for some consignment channels. What we have done internally, and the commercial organization has done a great job with this along with Viatris, is they have sliced and diced the consignment channel in multiple ways to figure out the ones that are actually not profitable and will not generate business in the future. We have looked at that and we have tried to make that at least break even or make some amount of money on that one.
We want to be careful because some of these patients actually need the product but cannot afford it, and they don't have insurance. We don't want to leave them high and dry. We're making it available, but available to them such that it doesn't create a loss for us. Then there is the other side of the sword, which is we do want to give—there's something going on. Our network is down, I guess. We do want to give patients access to our product while they wait for their payers to work out the reimbursement aspect of it. We don't want them to wait for weeks and months while the payers get their reimbursement process underway. While they wait for the reimbursement process to be underway, we give it to them for free.
That's a good channel for us because basically what that means is we do give it to them for free for a month. To Anders' point, most of these patients are on the product for four or five months. The first month is free, but the following three or four months will be paid for by the payer, which is what the process should be. It is a double-edged sword. We want to keep it as small as possible, but the part of the consignment channel that we keep, we want to make sure that it leads to business in the future. Hopefully, that's helpful. Anders, you want to add anything? No. That's spot on. To the question, the way it was asked, it was 27% in the first quarter, it's 23% in the second quarter. It goes in the right direction in our view.
It's still an important part to drive growth still, even though it's very hard for us to sit here and just explain in words what's the revenue impact because it's such a mixed bag of prices, from, as Santosh said, from negative something to something something. It is an important part of growth.
Thank you. I've got a last question here as well. With future trends, what are you seeing as being more profitable, digital marketing or the actual sales force?
Great question. As of now, I think the baseline still is to have salespeople out there. Could this go one day to that you could only do it digitally? Maybe. It's not impossible. Could there be equal contributors? Possibly. It's really, really hard to know. There are so many things you can do on the digital side. Potentially, going forward, I am still a firm believer that the sales force will be needed for pull-through and other things to help and assist the different offices with whatever it may be, actually, in the end, to get the product to the patient. I think it's a good thing they can do this hand in hand. I think that is what I see. Santosh, I invite you to review as well. There are so many things you can ask and answer this question, I believe.
Yeah. No, I think you've said it perfectly. I mean, the only thing to say is we just truly just started marketing. You saw Anders' slides. Some of those initiatives were starting in June, some of them in March, April. I think it's a little too early to make a call on which one is more profitable. I think you do need both. We can decide how we spend the dollars and allocate capital in the right way as we see how effective marketing is. Not every marketing program is effective. I think what is important is our marketing team cuts off those programs that are not effective quickly and translates those dollars into programs that work. They're still early days. I think it's too early to call that.
Yeah.
That's great, Anders. Santosh, if I may just jump back in there, thank you for addressing all the questions from investors today. The company can review your questions submitted today, and we will publish those responses on the rest of the company platform. Anders, before I redirect investors to provide you with their feedback, which is particularly important to the company, could I please just ask you for a few closing comments?
Sure, absolutely. We actually like to close with this. I think we answered all the questions. Somebody also in the Q&A asked if we're using patient testimonials. Yes, we are using patient testimonials. This is a very, I will say, this is a typical one in a way where you have a young mother that couldn't tolerate an oral iron salt. Infusions didn't work out for her either. She was very happy that ACCRUFeR was the alternative. Typically, after five weeks, as she states, my hemoglobin was finally in the 12s, which is the number you want to reach. It doesn't matter if you don't know what it means. It's the number you want to reach. She also says, I reached my doctor alone about ACCRUFeR sooner. That is really a key point. What Santosh has stressed as well, it's awareness. We're working on awareness.
This is a very typical case for a patient. Of course, we'd be very happy to receive patient testimonials like this one. By that, I'd like to say thank you. I know we're one minute over. Sorry for that. We also would like your feedback. I believe we have said thank you and have had excellent conclusion. Thank you so much.
Fantastic. Anders, Santosh, thank you once again for updating investors today. Could I please ask investors not to close the session as you will now be automatically redirected to provide your feedback in order that the Board can better understand your views and expectations. This will only take a few moments to complete. I'm sure it will be greatly valued by the company. On behalf of the management team of Shield Therapeutics PLC, we would like to thank you for attending today's presentation. Good afternoon to you all.
Thank you all.