Good afternoon, ladies and gentlemen, and welcome to the Shield Therapeutics PLC investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time via the Q&A tab, which should be displayed on the right-hand corner of your screen. Please just keep typing 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 we'll share the responses where appropriate, Tuesday on the Investor Meet Company platform. So before we begin, I would like to submit the following poll, and as usual, if you could give that your kind attention, I'm sure the company would be most grateful. I would now like to hand you over to the executive management team from Shield Therapeutics. So, Greg, Santosh, good afternoon. Good afternoon, everybody, and thank you for taking the time to join us today. My name is Greg Madison. I'm the CEO here at Shield Therapeutics. I'd like to take this opportunity to formally introduce our new Chief Financial Officer, Santosh Shanbhag. He's been with the organization now just over four weeks, I believe, if I can pronounce this correct. And he's a very, very welcome addition. We're very pleased to have him on board. As noted, we'll talk about the trading update that we put out yesterday. And at the end of the presentation, we'll be able to take some questions there. We're on a relatively limited time schedule, but we'll do as many questions as we possibly can at the end. And those that we don't get to, we'll certainly look to follow up in writing here as well. So we put out a trading update yesterday, and really was thinking through just how to balance the tone here, right, on the presentation. Because on one hand, we've got some really good things that are going on in our business, both in 2023 and is accelerated to 2024. However, we also had to put out news that we discovered that there was a data anomaly in our reporting with our third-party partner here. That's tough news to be able to put out there as well. So I think candidly speaking, we're very pleased with what we see on the underlying business, but, you know, it's hard to not acknowledge this new data piece that popped up yesterday. So, you know, we are, you know, disappointed to have to present this overall. We're frustrated internally here as well. But, you know, we identified it, we investigated it, and we obviously need to report it back, which we've done. The team internally here, you know, I wish many of you could be in this office with myself and even Santosh, in his four weeks here, and see the team that is here. Incredibly dedicated, incredibly passionate, takes a lot of pride in what they do, and always looking to do the right thing for patients, providers, for our shareholders. We take a lot of pride in what that is. So that's not really... So this whole thing is a bit of a disappointment for us. That being said, we also have a very resilient bunch of people here, right? That are just very focused on what needs to happen. When you're running an operating business, things sometimes happen, you figure it out, you go forward, and that's the team that we have here as well. So we remain very, very resolutely focused, you know, on our goal to make Accrufer the oral antianaemic choice, you know, here, in the U.S. market as well. I think, you know, lastly, before we get into the presentation, I think the most frustrating thing for us overall is if you could somehow just, you know, step aside from the data piece, you know, for half a second and look at what's going on in our underlying business. There's so many positive things that are moving in the right direction. We feel really good about the way things are trending right now, and there's more to come. You know, just at the end of 2023, there's more resources coming, resources coming in 2024. We think we have a very, very good plan in place and everything else. So that's the part we want, don't want to overlook here as well. So we'll do our best to kind of balance the tone here and make sure we're in a good spot. So moving forward here, let's jump into the 2023 business update on a high level. So three main goals for us. We want to maximize our total revenues. We want to continue to improve our Accrufer gross-to-net, and we want to continue to grow Accrufer prescriptions. You know, obviously, the prescriptions and gross-to-net lead us to that total revenues. So if we look back at 2023, we did have, you know, over a 3x year-over-year growth in our total revenues in the US for Accrufer, ending the year at $11,600,000. We also had, you know, 2.8 year-over-year growth in total revenues from 2023 to 2022. The right two areas, you know, areas that we'll spend a little bit of time on as we go forward here. In our second quarter updates, we spent a lot of time talking about, you know, how do we improve our Accrufer gross-to-net? We're making very good progress here. That increased on net sales prescription per prescription from $119 per prescription in the first half to $145 in the second half. And on the right-hand side, as we grow our prescriptions overall, we have 3x year-over-year growth in 2023 compared to 2022. Bear in mind, we've got our partner, Viatris. We got our full now sales team up and running in mid-May. So this is represents, you know, about six and a half months of that team being out there overall. And all that being said, you'll notice that in the fourth quarter, our growth rate wasn't to our level of expectations, right? We thought we could do a little bit better there. We've obviously made some operational changes in the fourth quarter that are now taking effect today, to address this lower, lower than expected growth. So from a financial perspective, we just think about revenues. You know, this is in the release as well. You see the breakdown here. Our U.S. net sales, our other income revenue from the Viatris milestone, and our ex-U.S. sales across the board, all of which totaling up to $17,500,000, US dollars, that's in comparison to 2022 at $6,200,000.... So Similarly is here on gross-to-net. As noted earlier, in the third quarter, we spent a lot of time talking about, hey, the first half of the year, the $119 doesn't progress as fast as we want it to, so we want to make some changes, and we are making some changes to address how do we get that increase, overall. First and foremost, it always helps when you have expanded payer coverage, which allows you to get just more prescriptions, you know, paid for and covered, which automatically helps improve your gross-to-net. We had a nice win in California and New York that we reported in September. Right now we're seeing very good progress from a prescription level, in those two particular states overall. One area we spoke just a lot about was this increase in the prior authorization submission rates by physicians here in the U.S. We implemented some changes in our patient access programs during the fourth quarter, back in October and November as well. Thus far, we don't have slides on it. We're seeing really nice results from that. Our PA submission rate increased pretty dramatically from Q3 all the way to Q4. It's up from 37% where we were at the beginning of the year, all the way up to 51% in the fourth quarter. And that's really with only about, you know, 4-6 weeks of actual time being implemented. So that sets us up really well as we go into 2024 as well. So here's our growth, right? So if you look at this just by itself and say, right, you know, how did we do last year? Really nice, strong, impressive growth. Again, with context, you've got this team out there that's been out there about six months. 47% growth in the second quarter, 58% in the third quarter, and 22% here in the fourth quarter overall. Right. These are real numbers, if you will. So by itself, you look at that of where we were last year and where we are this year, that really looks good, strong growth, and we're continuing to kind of focus on the execution side here as well. I would comment that our partnership with Viatris has never been stronger. We just, there's such a good collaborative state of mind here in terms of what we're trying to accomplish, how we're going to accomplish it. So there's always things that are popping up that we need to address overall, but a good, strong, dedicated partner in our, in our colleague Viatris, as we go forward in our mission here as well. One thing we did note here is that that fourth quarter performance was exactly to the level that we expected it to be. So one of the things we did, you know, internally at Shield at least, is we did strengthen our leadership and adjusted our sales leadership and our marketing team. So we brought a new head of marketing into the organization during the fourth quarter, and we also adjusted our sales leadership structure. Whereas before we had 1 VP of sales managing six frontline sales managers who then managed the reps, we've adapted that model and actually now have two area directors managing the six frontline managers. So more of a ratio, instead of 1-to-6 previously, now it's a 1-to-3 ratio. It's a high touch model. We think it's going to pay off significantly in the benefit side, just to enhance, you know, communication, coaching, and consistency. The other thing we noted there is that we believe we can execute better, particularly against our targets overall, right? So the first, you know, several months of the launch, I think both teams were out there pretty much visiting as many doctors as we can, scooping out prescriptions, and you see that in growth rates. One of the things we didn't do as well in the fourth quarter is stay focused on our targets, and those who call against non-targets. The reason why that's important is that for us, targets have much more value. They write many, many more prescriptions overall versus non-targets. So that consistency on reaching those targets, hitting their frequency overall. Again, we had to realign kind of what we wanted to do there. I think between both teams, just focus on the fundamentals and not allow any drift. It's not, "Hey, let's find prescriptions anywhere." Let's stay really focused on our targets and get them to right the first time and drive additional depth. So a little bit of basic blocking and tackling that we need to revisit here, and the teams are out there executing that as we speak right now. So here's the third-party data issue that we referenced, right? So we discovered this issue, we investigated the issue, and then we obviously reported the issue here as well. So this is from a third-party data provider, and you know, unfortunately, they had some methodology that was not exactly correct, where it resulted in an over projection of the prescriptions overall. What you see here is the prior reported prescriptions on the top line, the updated prescriptions overall, and the actual growth rates that I just shared with you on the previous slide. So at the end of the year, at 77,000 prescriptions, like I said, 3x, we grew versus 2022, and it puts us on a good trajectory. So this is one slide that just may help kind of put in characterization, you know, as we discovered this and now reported it, you know, kind of the before and after. Right. So the blue bars represent, you know, where we thought we were on the trajectory, if you will, based on the, you know, previous data that we reported. These orange bars now reflect, all right, this is the trajectory that we're actually on, right? So you can clearly see here as we looked at it, you know, we were kind of thinking at the end of the year, kind of budgeting toward the blue line. We're making plans for the blue line, et cetera. Now, in reality, as we discovered this on the orange line, we need to make, you know, several different operational adjustments, of course, with this. So number one, as we reported, you know, clearly, time to being cash flow positive. So if you're on the orange line versus the blue line, unless there's some, you know, event that's going to happen to close that gap, that time is going to move up, right? So we've reported there that, you know, our aim right now is to be cash flow positive in the second half of 2025. Previously, that was the end of 2024. So that orange bar line so certainly puts us on that trajectory in terms of the second half of 2025. So if you think about 2024, you know, and our business priorities, they're listed right here, right? So you've got maximize total revenues, you've got grow preferred Rx and the gross-to-net, and then talk about the path to cash flow positive, if you will. So the left-hand side, I think it's pretty clear. You know, we're going to be driven primarily by our US revenue growth. And it would be remiss to say that we're actually making some really good progress... you know, on our ex-US opportunities, right? So, you know, China continues to enroll. That enrollment has actually picked up, a little bit nicely here. We continue to make progress on our pediatric study, which, you know, should be done, you know, right around the midyear timeframe. We should get the last patient enrolled there as well. Korea continues to make progress. We're expecting approval in Canada, by the end of the second quarter as well. So our revenues will be driven by primarily U.S. in the near term, but we are making very good progress with some of the ex-U.S. opportunities, as well. The middle bucket, spend a little bit of time here, right? So obviously, we want to grow prescriptions, we want to improve our Gross-to-Net, right? So, as I noted, we've realigned our sales focus and prioritizing activity against targets. We've adjusted our sales model as of, December of last year, and we fully expect that to, benefit us and pay off with some of our, basic blocking and tackling. Where we're making really, really good progress is on our Gross-to-Net. So I talked about the increase that we saw both in the fourth quarter, or pardon, the second half of last year and the first half of that year. We fully expect that to continue to accelerate. One of the things we were able to do at the end of last year is lower one of our payer rebates, which is important because not only helps lower our commercial overall Gross-to-Net, but also helps lower our Medicaid best price, right? So the simple way to think about this is that any prescription that was written for a commercial insurance plan or a Medicaid program in December 2023, as of January 1, 2024, you write those same prescriptions, they're both worth more than they were just three days ago. So that's a fairly good step change for us overall. So we put out a target, you know, previously of $220-$240 by 2025. I think we're very comfortable with that type of target that we're looking at here. We really expect that improvement in the gross-to-net just to continue to improve and accelerate as we go through 2024. And then we have the introduction of our field reimbursement team. We've talked about that previously on one of the calls here. A team that's designed out there to provide support and education to physicians to help continue to increase that PA submission rate, which is just critical for us to get that up. We're seeing nice progress based on what we did in the fourth quarter of last year, and again, that's going to continue and accelerate as we go forward as well. And then last but not least, is the path to cash flow positive. So as noted in the earlier chart, you see the trajectory that we're currently on. As we sat down and, you know, Santosh, you know, being here the last four weeks, this is where, you know, we discovered this overall. You know, this is where we spent a lot of time trying to figure out, right, how do we make this, you know, work, if you will. We had very tight control over our operating expenses, made a number of different working capital enhancements as well. So all of our focus right now is any dollar we're spending, you know, if it's all possible, it's going to go drive tied directly to supporting Accrufer growth and hitting that top line number here as well. And then we ended the year at 2023, at just under $14,000,000 cash balance. As noted, aim to turn cash flow positive in the second half of 2025. Okay. So I believe that's the end of the presentation here. Just give us a moment here so we can start to scroll through some of the questions. Some of you were nice enough to submit questions ahead of time. There's definitely a number of questions as I'm scanning it here, the chat board here. Just give us a couple of moments, let us kind of collect our thoughts on some of these. As noted, we're on a relatively tight timeline, so I'm looking at the number of questions here. There's definitely no way we're going to be able to answer all these on this call. So we'll look to take about, I'd say, 4-5 questions and we can go from there. Great. Santosh, if I may just jump back in there. Give you a few moments to have a look at those questions. And in the meantime, ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab that's situated on the top right-hand corner of your screen. As the team takes a few moments to review those questions that have been submitted already, I would like to remind you that a recording of this presentation, along with the presented slides and the published Q&A, can be accessed via your investor dashboard. Santosh, Greg, as you can see that we have received quite a large number of questions and given the significant attendance on today's call, so you may not be able to answer them all directly, but of course you can review all of the questions and add any additional responses then after the presentation. But perhaps now, if I may just hand back to you just to read out those questions and get your responses, briefly, if you will. And then I'll pick up from you at the end. Thank you. Great. So, you know, I think obviously with the context of what we discussed in the opening there, there's a number of questions related to the third-party data and the, you know, overprojection, things like that. There's really not much more than can be said beyond what I stated earlier that, obviously, you know, we're disappointed. Obviously, we have to present that. I know we're happy about that for sure. But, you know, we discovered it, we investigated it, we reported it. We believe we've got a understanding of, so what happened overall and how it's going to be, will be fixed going forward. So I'm not sure what about the go forward piece, overall, but you saw the impact of what it did for us overall. So I think internally, yeah, we're disappointed, but we've reset, understand what needs to get done. We have a very good, strong, growing business. A lot of good things are happening underneath that as well. We continue to stay focused on that piece, if you will. But, Santosh, add in the context. No, I think going back to what Greg just said, I think the fundamentals of the business continue to remain strong, and we look, we are excited about it. It is unfortunate that there was a data anomaly with the from a from the third party, but we have identified it. We have, and we have a path moving forward to, you know, limit what we can do on that question. Yep. Right. So the question here around even on the Gross-to-Net, right? So it says, you know, in the third quarter update, you made reference to actions. You know, we've seen the improvement on the Gross-to-Net in the second half of the year. So the question of, you know, did Q4 drop versus Q2 overall? So we kind of hit some of those points here... This year we're really excited about, and I think the team is gonna really make this some job with some of the things. So us, we identified that our average Net Selling Price year to year last year was not where we needed it to be, and so we actively started to make some changes here as well. The way to think about Gross-to-Net, so nowhere we want to go to overall. You know, I get less worried about, you know, any kind of minor quarter-over-quarter fluctuations, because that, that can really be impacted by your split of business. For example, if you have more Medicaid business versus commercial business overall, that can have, you know, minor impact. So, so whether or not it went from $148 to $142 to $324, that's, that's immaterial, honestly, in the grand scheme of things. It's really like, what do you want to see from a line of sight on the, the overall trajectory? And that's where we're making excellent progress. So as noted, in the third quarter, pardon me, in the fourth quarter, specifically on October, we made some changes to our patient assistance programs, whereby, you know, physicians, we offer physicians that, hey, you need to write a prior authorization to get access to Accrufer because patients need to try and fail, you know, a general OTC iron. If you write that PA and submit that to the payers, if it's covered, the patient pays $0 for a prescription of Accrufer per month. If it's not covered, they pay $25 per month overall. But you've got to submit that prior authorization. If you don't submit the prior authorization, then the patient is paying a much higher cost, and we're not gonna continue to subsidize, you know, those patients overall, right? So we wanna really start to, you know, thoughtfully think about, you know, instead of prescriptions at any cost, we want to start to modify our business and really be more intentful of, hey, if somebody's not willing to do the work, then we're not gonna just subsidize the patient for the sake of getting a prescription overall. So what we noted by implementing that simple change, we saw our PA submission rates jump up, you know, slightly in the fourth quarter, which is great. That's exactly what we want to see. Bear in mind, we did this in the middle of October, so you have about eight weeks of real data here, but we've seen a nice increase in the PA submission rates. We expect that to certainly continue to go forward here as well. The second key thing noted is during the second quarter of this year, we're gonna bring on the field access reimbursement team. Again, they're being hired as we speak. They'll be up and running as of we start the second quarter here. That team is specifically designed to provide support and education to physician offices that are having challenges, if you will, submitting prior authorizations, right? So they can see, okay, where are the, where are the PAs kind of backing up? You know, are there any offices that are having particular challenges with the prior auth, and provide support and education, all with the goal to help that office increase their PA submission rate. If we increase that PA submission rate, there's a more likelihood that the PA submitted is gonna get it covered. It's a revenue-generating script, but we'll still offer, you know, the access for the $25 as well. So that's a key indicator for us. So the actions we've taken in the fourth quarter are starting to pay off. There's more resources coming here as we hit the second quarter as well. And then lastly, as I noted in the presentation, in the last year, we were able to reset some of our payer rebates. That has a huge effect for us on the Gross-to-Net side. So if you combine all these kind of different actions that we're looking at, we're making some really, really good progress on that side, and we continue to make progress with the additional resources we have coming in. So, excellent question on that side. Santosh, I'm going to toss one to you, because, a couple questions on just, you know, actions around the cash flow positive, right? Yeah. So obviously, we had, you know, as we look at the orange bar around that trajectory overall, we look at cash, you know, flow positive out in the second half of 2025, but just a little bit about some of the operational work that we've done internally. Yeah. Yeah, no, and like Greg said, in light of the recent third-party data issues, you know, we are on a different trajectory now, and so we look at our business holistically, took a deep dive. We've made adjustments to our business to make sure that our existing resources get us to cash flow positive in the second half of 2025. And some of those, as you can imagine, we are already hyper-focused on making sure that our investments are linked directly to the growth and scaling of Accrufer. So we looked further into some of the G&A expenses, and we were able to delay or cancel some of the programs and move that into 2025. So found some potential opportunities for savings there. But our focus was a little bit more targeted towards working capital management. So the cash element of it. So things like we have been able to manage some of our supply chain costs. Example, our API and production costs, making sure that it aligns with this new trajectory that we are on. So there were some savings associated with that cash savings. We've also improved our distribution process. You know, how we distribute our product from our facilities into a 3PL, into a warehouse, and then move all the way into a patient's hand. We've been able to find some efficiencies there, and we'll be implementing that as we speak in the first half of this year. And then finally, obviously, we have made, we've undertaken multiple initiatives so as to be able to manage our accounts receivables and account payables. That working cap management has actually helped us find some significant cash savings, and enabled us to get back to making these adjustments so that our existing resources help us to get to cash flow positive in the second half of 2025. Great. Thank you. Let's see here. So there was a question about XUS. I think I covered that. There's a little bit on Norgine here as well, but let me just kind of repeat that as well, how the XUS things are progressing as well. So obviously, we reported in this release that Norgine, we've collected GBP 1,500,000 in royalties from our partner, Norgine in Europe. I'll continue to work with Norgine on focusing on the right customers and driving, you know, impressive growth here as well. We've had a lot of conversations with them. They are committed to the product as well. It's an important part of their portfolio, and we're going to continue to work with them on the tactical execution in a number of different areas that... that we believe could potentially be improved. You know, they're doing the right things. I think they're saying the right things. We'd love to move that a little bit faster if we possibly could, because the relationship is good at this point in time. On the other pieces, the development side, as noted, Canada, while we did expect approval, I think we previously talked about timing of approval in the second half of 2023. That's moved out. We really haven't had any communication to indicate anything overall, but just that's a delay. You know, our partner in Canada, KYE Pharmaceuticals, has been very active in kinda, you know, pressing forward into overall. It does look like we'll have an answer here by the end of the second quarter. I could be still optimistic about the opportunity there as well, and excited to get that in the hands of our Canadian citizens, pending approval. Then China, as I noted, China is continuing to enroll their patients overall. It looks like we should be able to, all things being equal, get the patients enrolled before the end of this year. That'll put us on track for potential approval in the second half of 2026, if all continues as going. Korea, they finished their PK study. We should be filing for approval at some point this year. So that's progressing very nicely for us as well. So on the ex-US side, things are working well. I also mentioned our pediatric study. So we've been enrolling that, you know, for a number of months at this point in time. It looks like we should be on track to have that patients enrolled in the middle part of this year, which will allow us to think about sort of potential indication expansion, both in the U.S. and Europe, likely in the latter half of 2025 or early 2026 timeframe. So some really exciting progress on the ex-U.S. side here as well. Okay, I think we have time to hit perhaps one more question. There was a question on just the Q4 growth rate of 22%, you know, how that portends, you know, for this year and some of the action we're taking, overall. I think just we noted there, there were just some dedicated teams out there, you know, working really hard. I think we made -- you know, we certainly, as we were getting into the fourth quarter and approaching towards the end of the year, you know, we weren't actually thrilled with some of the level of execution we were seeing. And we've seen this team perform, you know, I'm talking about our field sales team here. We've seen them perform at a very high level, you know, before, so we know they can do it. And we just didn't execute the way that we thought and that we've seen before, that we know we can in the fourth quarter. So for a number of different reasons, we made some operational changes. I noted the sales leadership, change in the sales leadership structure, that was done in December. So that's already seen very, very positive signs in terms of level of communication, really focused on, you know, a small number of things to go really, really well instead of trying to do, you know, 15 things which are not going to get accomplished. So we're really comfortable with what we see right now on that side. As noted, our partner, Viatris, kind of witnessed the same thing, and that collaboration, that communication we have around: So what are we hearing? What are we seeing overall? This is not a physicians don't care to write the product. In fact, so we did some recent market research here. We did a little bit of qualitative research. We're doing some quant research now, but, you know, my head of marketing, you know, keeps walking in my office, and, you know, she goes off these calls, the physicians are like: "When is this gonna launch? I'm excited to write it. I have so many patients that could benefit from that." So we've not lost sight at all of the market opportunity. It is absolutely there. We just need to really focus and execute better than we think we did in the fourth quarter. And, we've got the full team committed to be able to do that. So I think the option, you know, looking ahead for us here, it's very, very bright. Every piece of data we have tells us that the market is available. You know, patients are in need, physicians are looking for an option, if you will. You know, recognizing that it's not as easy as it sounds. It's not like you walk in once to a physician and you present a paper, and you walk out, and they just start writing it all over the place. It does take reach, frequency, repetition in order to kind of break through whatever habits that they've been doing before. So we feel very confident about the opportunity. We just need to kind of focus our resources and execute a bit better, both on the sales side and we're excited for the launch of new marketing initiatives here as well. So despite, you know, all the noise from yesterday, you know, the base business overall, you know, we're gonna focus on growth. Growth tonight is moving in a really, really nice direction, you know, across the board there. We're very comfortable with where we need to kind of focus on and move forward here as well. We're gonna do everything in our power to get to that cash flow positive in the second half of 2025 with the existing resources we have sitting here today. Anything else to add? I think that's it. Good. I think with that, I'm just scanning one last time to see if there's any other questions, just trying to cluster these and group these together. Yeah, I think that should be it. So, I'll just kind of back over to you, if you will. Perfect. Great. Thank you very much indeed for taking the time and addressing those questions that came in to investors. Of course, we will be able to give you back all of the questions that were submitted today, as well as any further ones that do come through. We'll get you those back immediately after the presentation, and then just for you to review to then add any additional responses, of course, we're happy to do so. We'll publish all those responses out on the platform. Greg, perhaps before, really just looking to redirect those on the call to provide you their feedback, which I know is particularly important to yourself and the company. Let me just ask you for a few closing comments from our side. That'd That'd be great. Yeah, absolutely. So first off, thank you for taking the time today. We really appreciate, you know, all of our investors' support and things like that. You know, as noted, you know, on the underlying business, we see a lot of good things are going, and I wish you could be here internally with the team just to see, you know, the focus, the dedication, the passion of what we're trying to accomplish and, you know, staying focused on that goal. You know, obviously, a balanced trading update here, you know, with the reset, but we're very confident in terms of, you know, what happened, what we need to do, how we need to execute, how we're going to get there as well. And we look forward to updating you everybody along the way here, as well. So thank you for your time and questions. Thank you. Perfect. Great. That's great. Thank you once again for updating investors this afternoon. Could I please ask investors not to close this session, as you'll now be automatically redirected to the opportunity to provide your feedback, in order that the management team can really better understand your views and expectations. This will only take a few moments to complete, which I'm sure will be greatly valued by the company. On behalf of the management team, we sure thank you for your courtesy. We would like to thank you for attending today's presentation. That now concludes today's session. Good afternoon to you all.