Shield Therapeutics (LSE:STX) — Final Results for the year ended 31 December 2021

0:01 Good afternoon, ladies and gentlemen. Welcome to the SHIELD THERAPEUTICS Final Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode, and this meeting is scheduled for forty five minutes. Questions are encouraged and could be submitted at any time using the q and a tab situated on the right hand corner of your screen. Just please simply type in your questions at any time and press send. However, company may not be in a position to answer every question it receives during the meeting itself. However, the company review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we would

0:33 like to submit the following poll. And if you would give that your kind attention, I'm sure the company would be most grateful. And I'd now like to hand over to CEO, Greg Madison. Good afternoon or good morning to you, Greg. Great. Thank you very much, Mark, and thank you everybody for, joining us today to, listen to our presentation here. We're excited to talk to you about some of the results we have accomplished, particularly over the last, several months as we turn the clock into 2022, as well as provide a a business update and go through our 2021 financial results. So thank you for joining us this morning. I'm joined by my colleagues that you'll hear from during this call, Hans Peter Rudolf, who is our CFO, and, Jose Manoio, who is our chief medical officer. And we will progress forward here. Okay. So from the business updates and highlight, right, we have continued to make very, very strong headway towards our goal of having Acrofor be this brand leader in oral iron therapy, and that is why most of us have come to this organization is to turn Acrefor into this brand leader in oral iron therapy.

1:34 We put out an r and s this morning and announced a couple of exciting updates that we'll go through during this call today. First and foremost, we announced a financing agreement of 10,000,010 million US dollars with an existing shareholder. Very important accomplishment here. As many of you know, it is a very, very difficult marketplace right now out there from a fundraising perspective. So we are very happy at our accomplishment, and we appreciate the support of AOP, our second largest shareholder, in funding the company with the $10,000,000 funding. And that certainly extends our cash runway and allows us to continue the good work that we're doing here for sure. We also are making excellent progress across the three main focus areas that we've talked about from the very beginning of what we need to do in order to be successful here, and that's driving awareness, generating clinical experience and prescription growth, and establishing payer coverage. So we'll talk about what those look like as we progress into 2022.

2:31 And last but not certainly not the least, but least, is closing kind of the final books on 2021, and I think that's where we'll begin here. So,

2:41 would you mind, you know, updating everybody and just kinda putting the final close on 2021 financial highlights, please? Yes. Thank you, Greg, and good afternoon, everyone. I'm happy to walk you through the 2021 financial highlights, details of which you also see in the RNS, which was released this morning. I'd like to focus on three points. First of all, revenues, which we reported at £1,500,000 for 2021. As you see right off the top here, obviously, that's a significant decrease from the 2020 reported revenues. But the reason for that is primarily due to the fact that in 2020, if you recall, we received a significant upfront payment, from, our Chinese license partner upon signing of that license agreement.

3:28 And the the the current year revenues, as said, this week are a component of of three components that make up that amount. First of all, the royalty income from ferrocrew sales in Europe by Nordgene, which amounted to £900,000. That's an increase of roughly 30% from the prior year. We also reported £100,000 of net product revenue from Aquafer sales in The United States, and I like to open up a little bracket here. I think you also have that information in the RNS, but, obviously, that number is fairly low. It is low because we had very limited payer access in 2021. As a matter of fact, our first commercial payer contracts were say signed in December or took effect in in late December.

4:13 And so as a result, we effectively subsidized virtual subsidized virtually all of our prescription sales in 2021. So even so, we had some volume to report. That volume did not really generate and translate in any net product revenue, which is depicted in the in the £100,000. And then last but not least, we also recorded £500,000 in an upfront payment from Korea Farm. Obviously, that being significantly smaller as I just alluded to, in comparison to the previous year, upfront payment we received from ASK Farm on the signing of our Chinese license agreement. We reported a loss of £19,300,000 for 2021. That, again, compares or or or if we will compare that to 2020, there's two major components, that resulted to to the significant increase in loss.

5:06 For one, as just previously explained, our net revenues decreased because in 2020, we had that extraordinary income that we or revenue we were able to record.

5:16 But then also, I think it's important to point out, with the launch of our US commercial, activities, we effectively started to incur some selling costs. Those selling costs in 2020 were only £300,000, and they increased by 10,000,000 to £10,300,000 in 2021, thus resulting obviously in a significantly higher loss for 2021. Our net cash balance at 12/31/2021 was reported at £12,100,000, and that further decreased to £4,200,000 effective 05/31/2022. If you look at the reported previously reported net cash figure that we reported in at June 30 06/30/2021, for that six months, we had an average monthly cash burn of £1,700,000.

6:10 That obviously is is continuing at a similar rate if you, you know, you know, follow the numbers here to the 4,200,000 at the end of May, but you can also see that with that average cash burn in '22 dropping to 1.5, 1.6, you slowly start to see the impact of additional revenues. Now the rate we're gonna be able to eliminate the net loss going forward is obviously depending on how much we're going to potentially increase operating costs and essentially reinvest into the commercial organization. But that's what I have for the '21, financial highlights. I'd like to hand it over back to Greg, and he's gonna walk us through some of The US commercial activities both in the prior year as well as in 2022. Great. Thanks, Hans Peter. And I wanna take a step back and just remind everybody, you know, why it is we're here and what we are trying to accomplish. And it was just over a year ago that the launch in The US actually commenced here. You know, let's kind of review kind of the key components, what we're trying to accomplish here that we're getting the details details of that as well. What's really exciting to us, and this has been seen over and over again, you've got a very large defined market here in The US. You've got twenty million individuals suffering from anemia.

7:19 You've got physicians writing prescriptions actively every single day to treat those patients. We have over 13,000,000 oral line prescriptions written every single year in this marketplace, and most of those, prescriptions are focused on primary care or general practitioners in women's health. Those are really the big areas. You will see over and over again, we continue to hear this over and over, that the issue out there in the marketplace is poor observability, poor tolerability, high discontinuation rates with a lot of conventional irons, mostly spheric sulfates. We also believe that we have a potential best in class solution. And when we get the chance to get in front of a physician or make them aware of Aquifer, the interest level is there. And that's very, very encouraging for us. We'll talk about that as well, but we are very, very emboldened by the feedback we're hearing overall. It's just how do you scale that up. You've got a great team here. I'll talk about actually, there's a brand new US commercial leadership team here that's come on board since the January time frame, that brings excellent experience and motivation.

8:21 We're talk about how well we're progressing across a couple of our key metrics. Then, obviously, this market has significant revenue potential, and we are just just scratching the surface. And we have a nice long runway ahead of us with the patent coverage going all the way through 2035. The twenty million patients here, the good news is physicians are treating those patients every day. We're not educating them on the need to treat. We're educating them on a new way to treat those patients, and that's on the right hand side in this slide with the 13,000,000 patients up primary prescriptions are being written for oral iron every single, year. And, again, the tolerability issues are the biggest challenge that you see out there, we and think we've got, you know, a better mousetrap to kinda solve this need, if you will. From a patient perspective, this is really how it starts to play out. This is how we're thinking about you know, this is not this is how we position the product right now is that pictorial on the right hand side. So patient goes into, you know, a women's health practitioner, an OBGYN, get diagnosed with iron deficiency anemia. They get put on ferrous sulfate or an OTC iron today. That poor patient, you know, tries it.

9:26 Unfortunately, to how we develop side effects or a high percentage of patients develop side effects, either discontinue the oral iron or switch to a different OTC iron and maybe even a third OTC iron, and you end up in this very, very unsatisfactory cycle of switches, discontinuations. What the patient is trying to do is just find the oral iron that they can actually take, that will they will tolerate, that will be absorbed the right way, and will treat their iron deficiency anemia and get them back feeling the way that they should be overall without the, you know, the extreme fatigue, the mental confusion, everything else that goes on there. And these poor patients, this is not a easy journey. You know? They they are suffering during this time here as well. They're not right. They're not feeling the way that they should. They're suffering from a a important disease, and they're actively seeking out new options and new treatments.

10:16 The biggest challenge that we talked about right from the very beginning is the awareness of. Right? And just, you know, how physicians how do we make them aware of AcroFer, and eventually, how do we make patients aware that, you know what, there is potentially a better mousetrap out there overall, and you don't need to suffer the way that you're suffering today. So this is really what gets us out of bed in the mornings to make sure that we can deliver this medicine to as many patients as possible. We've talked about how Aquifer can be, can be a a great product and what makes it different overall. And, on the right hand side, what we look at here is that the fact that we're a ferric iron surrounded by this small tall structure, and this small tall structure shields the iron, which basically allows it to travel all the way down to the duodenum, be absorbed, and, do this in a way that is both in a low dosage form, but avoid some of the issues that you run into with the conventional irons today or the ferrous sulfates.

11:08 A real big difference there is those ferrous irons or ferrous sulfates overall, once you take that product and hit your stomach, it dissociates in the stomach. You've got free iron now circulating in the gut, irritating the line of the gastric mucosa, creative reactive oxygen species, and this whole cascade of GI kinda adverse events starts taking place. In our clinical trials with Acrofirm, our adverse reactions were less than five percent, and our discontinuation rates are less than five percent. So when we get the chance to actually see this in front of a physician overall and make them aware of it, that interest level is right there. Right? And you gotta make them aware, gotta get the interest, you gotta get them engaged, then we'll talk about how we actually translate that, into an actual prescription. But the story, the messaging, and the positioning is resonating extremely well that we see thus far.

11:59 To reminder, we're sitting here today in the end of June, and it was just about a year ago that this official launch started here in The US. So on the left hand side, we've talked about what the marketplace looks like. You know, in the middle bucket here, as we prepare to launch, your payer coverage was going to be critical. One of the big things down at the bottom that we wanted to be sure of was that patients when a physician wrote a prescription for Aquifer, that what the patient would pay from a cost perspective was pretty similar to what an OTC iron would be. And then the right hand side, we've talked about this in previous conversations. This is the biggest challenge, right, is you had a very, very short period of time in which the decision was made to launch in The US. You didn't have awareness. You didn't have KOL engagement. You didn't have advocacy. You didn't have kind of payer coverage overall.

12:45 So all that started right on top of the watch. Right? So we virtually started from scratch with a small sales team out there, you know, some basics out there, but you didn't have any of that run up overall that normally you'd like to have, and, you know, that's fine. We don't understand that that's, you know, what we need to do and that's what accomplished. So you take that consideration of where we were and where we're gonna show you where we've accomplished, we've made tremendous, tremendous progress. So, yeah, I'll skip past the first six months of the launch, which we've talked about before, was a lot of foundational type of items. Right? How

13:17 do we start increasing awareness? How do I get our reps in front of doctors? How do we start to generate some of that clinical experience? And as we went into the January time frame, these are our '20 two priorities. And I think we've been very, very consistent on what we need to do in The US to make this product successful. And those are three main things. One, drive awareness. Number two, how do we generate clinical experience and increase the number of prescriptions? We call it breadth and depth of prescribing with new writers starting to write ACRA for the first time and converting those new writers who are trying it into kinda more established writers, and that's the the depth component here. And, certainly, last but not least is on the patient access side, primarily payer coverage. So awareness, prescriptions, payer coverage are the three things that we've said from the very beginning, and I'm really happy to tell you that there's been very, very nice progress on each of those fronts.

14:10 We'll talk about those in a minute. Down the bottom, not to overlook this, there's a quote. So we have done a lot in the last, you know, call it four to five months. Jose and his team have conducted multiple advisory boards, KOL discussions, etcetera. You know, doctor Schulman, who's out of, Northwestern University, was one of those people that, we got exposed to overall. And, you know, this his his quote here, I'm not gonna read it to you, but I think it's it's emblematic of what we hear and see quite often. Right? It's the fact that they like Acrefer. They look at it, and they see, you know, his terminology here is it has a potential to become the product of choice. It could be a game changer for my patients. Right? So, yeah, we don't take that lightly. You know, that's a great, great response. Then it's really, alright. How do we really capitalize on this, and how do we do it? And the team has been doing, I

14:58 think, a tremendous job, a, with a small team and, b, with very limited resources. Right? So everything we have done has been done at a very small scale. We need to figure out how to take advantage of this full opportunity, but we've had nice progress. So let's go through awareness, prescriptions, and payer coverage, you know, each one. So on the awareness side, since January, we have really tried to amp up a lot of things we've done on the awareness side. I just referenced Jose and his team have done a lot of different things both on the the medical education side, advisory board side, you know, customer interactions. We actually attended our first two, conferences, you know, over the last course of the last couple of months as well. So we're really trying to do a lot more to generate that awareness to kinda complement what our field force is doing out there as well. I think those efforts are directly translating into what we're seeing from a number of first time writers and what that trend is now looking like. Right? So these are new writers of Acrofor. So writing Acrofor for the first time, these are all unique writers over the first four months of this year. And you can see the number of first time writers has virtually doubled since January.

16:04 We've got over seven hundred first time writers of Acrofor since the beginning of the year. So we're making excellent progress. This is a very nice leading indicator for that awareness as well as interest, and then actually putting pen to paper and actually writing prescriptions as well. So speaking on prescriptions, the second kind of point here, we are seeing a continued acceleration on the prescription side. We saw over a 100% growth here from q one into q from us compared to q four of last year, so up to almost 4,000 prescriptions in just the first three months of this year alone. Who is writing those prescriptions? It's exactly where the big market area is. It's primary care and women's health or general practitioners of women's health is the the maybe the correct terminology way to say that. So we are really pleased with some of the acceleration we're seeing. What also is nice here is, you know, I referenced that towards the end of the year, we started to bring in you know, we had a change in the commercial leadership, organizations. We brought in a lot of brand new people that bring the the right experience, the right level, and I'll show you them just shortly here. One of the things we did was brought in our own VP of sales as well as our three regional sales directors.

17:11 We moved away from the contract model for the field sales side and brought them in house. As we did that during the first quarter, we took a very close look at our 30 reps. And, you know, to be perfectly candid, you had some reps that are absolute superstars driving, you know, great, you know, results overall, and you had some that, you know what, they're just not where we need them to be. So we took a very hard look at that. We kinda moved out about 12 representatives over the course of the first quarter, so really about a third or more of our Salesforce. We kinda moved them out, for lack of better expression, and we're in process of hiring new people there. So the first quarter numbers you're looking at here, we're really done with probably about 20 of our sales reps out there in the field actively every day. We're still kinda finishing up the the hiring process of those 12 vacancies we've had, but I think the results we speak to, it's kudos to those 20 people. And it gives you a little glimpse of what we can do here if we get the right people on board, the right training, the right etcetera because a lot of these numbers are being driven by a handful of our strongest representatives. So we're really happy about that as well.

18:17 Last but not least, third is the payer coverage. And, again, very significant progress here. I think when we last spoke, maybe early in the part of the year, we had just signed some contracts at the end of December on the commercial side, so big PBM agreements. At the end of December, we put an announcement and said, hey. You know what? We signed agreements. We're at 40,000,000 covered lives. Great. And what we communicated was we expect that that coverage of covered lives is going to continue as we progress throughout 2022. Lo and behold, here we are today. We're up to a 100,000,000 covered lives right now across both the commercial plans and the state Medicaid plans, which are the two big segments here in The United States. For those who may not know, each Medicaid plan, it's run it's a state run plan. Overall, it says 50 of these out there, and, obviously, it's geared by population. So some of the bigger states is where you wanna spend a lot of your time and focus, and we've got some really big states that have come on board here. This is relatively new development. This is kind of the the March, April time frame that this started to kinda work its way through where we started to get coverage in big states like Texas, Florida, Georgia, for example. So I think we're up to about 14 total states right now, but we've seen really nice progress from really the end of last year with zero covered lives all the way up to a 100,000,000 covered lives. And, again, we'll continue to see that progress as we go through pardon me, as we go through 2022, but some excellent progress there. And, importantly, what that's gonna do for us is the number of prescriptions that now start to come in, you know, I refer to it as a

19:48 funnel, if you will. Right? So we've got prescriptions coming in the top of the funnel, which is what we're asking our field team to do. And then as patients kinda go into the funnel, we figure out, alright, who has coverage, who has reimbursement. If it is, if they do have it, great. That's a a paid prescription for us. If they don't have coverage yet, that's still a patient assistance prescription, but that ratio of covered prescriptions versus patient assistance prescriptions is gonna continue to accelerate and, shift more toward the paid side. So excellent progress there. So in summary, if you think about awareness, prescription growth, payer coverage, and new writers, every leading indicator I would like to see in terms of is our business growing, is our business progressing overall, we are seeing very positive signs across each of those indicators across the board.

20:35 Last but not least, the new team that is in place here. As I mentioned, when I came on board last year, I inherited a small commercial team. They did, you know, some good initial work overall. However, I think we've kinda brought in some brand new people here who bring kind of the right experience, the right passion, the right motivation. And this is a very, very talented group of people who, in each of their respective areas, they bring great experience. They know how to launch brands. They know how to grow brands and establish them as well. They know how to do it in a very small start up environment as well. So excellent, excellent team, and I think all of us here, from our level are very, very pleased with what we've seen in the early signs here as well. So let's turn to the financing. So that was the other big announcement and big accomplishment we talked about here today. But, you know, Hans Peter, if I could turn that over to you to walk through this slide, that'll be great.

21:24 Sure. Yes, Greg. I'll do so. Well, obviously, as a CFO, I'm extremely happy to report that we are able to secure some financing and to extend which will allow us to extend our cash runway to approximately the end of calendar year 2022. As you'll appreciate, and Greg already alluded to that, the the market conditions have been anything but favorable. This is an extremely difficult environment to raise any capital and get any financing done. In fact, there was probably a number of months where not a single transaction occurred in the pharmaceutical biotech space. So to to actually have been able to execute, this financing deal and to be able to to raise funds at this very difficult time speaks by itself and is is a testimony to to our efforts and, obviously, to the shareholders' belief in our in our in our product here.

22:11 This is obviously a long standing shareholder, who believes very strongly in our success, which is evidenced through through through this financing arrangements, this financing agreement.

22:20 You see here the terms that we agreed here, with this shareholder, on this financing. There's interest rates, there's securitization. We have repayable option, and we have a conversion feature.

22:34 All of these terms are effectively what you have to expect, in a situation at company like SHIELD where you're at. And then we feel those are based on discussions we had with other prospective parties, pretty much market conditions. This is what you have to expect today, and then as well the discount, which I wanna point out, is something that it's just something that you have to grant if you want to raise capital in these very difficult conditions. So we're happy to have had the opportunity and be able to to to get an agreement here, and we hope that this is significantly extending our runway to effectively continue to look at at options, strategic and financial nature as alluded to in the bottom of the slide. So we continue to look very hard to find long term solutions, and I believe that, if we find the proper solutions that we certainly have a very bright road ahead for us here. As Greg alluded to, this this drug is received very well in the commercial space by everybody we spoke to, whether it be writers or patients.

23:31 There's been no surprise here. It will just take time to create the awareness and to get the test, to effectively ramp up the the revenues. Greg, maybe I'll just hand it back to you here. Great. Excellent. So as we view things. Right? So we talked about the the key indicators that we're looking at overall and, really, how do we continue to accelerate that growth. Right? And what do we need to do? We're gonna keep, you know, working with our team here. But if we wanna bring this to the level that it's needed to really capitalize and turn Acrefer into that oral line of choice, you know, we need to make additional investments. Right? And this is really what we're targeting on from our view. This is really what we think needs to happen. A, you need more field people out there. Right? Our 30 person team, we talked about them overall, really 20 now, but soon to be 30 again.

24:19 They're doing a great job, but we need more bodies out there. We really need to think about how to get that marketing strategy up and amplified a a bit more than it is right now. You look at any pharmaceutical biotech company today, you know, it is we have been a very field force driven, and we've done very little to date in terms of, like, you know, providing air cover to them and really talking to those physicians when our reps aren't there, we need to do more of that. And if you look at any company, that is really the strategy, especially nowadays, to kinda complement your field force, with the right kind marketing programs as well. Obviously, we wanna continue the data generation. We have a pediatric study that is, currently enrolling right now that can open up another kind of opportunity down the road for us in terms of a, a pediatric indication.

25:04 So we'll make sure that we're appropriately investing in that trial, conducting that trial, but building the right infrastructure here for ourselves as well. As you mentioned, you know, we are looking at a number of different options overall in terms of both, you know, how do we do this as, you know, an option a as SHIELD as our own versus, you know, maybe thinking about other strategic options that we had may have available to us. And so we're constantly looking at those opportunities, but we're gonna continue to move along. But this is really what's gonna need to be done in order to get the the the business up and running there, to the level that we expect it to be. So in summary, you've got a 2,000,000,000 to market opportunity. We've talked about, you know, the reasons why we're here in terms of, like, the patients we're trying to serve, what the challenge that they have is right now, what that opportunity looks like and can bring.

25:49 We are very, very happy with the progress we've made across, again, those three main areas that we need to kinda hit on, but there's so much more we need to do, and there's so much more we can do. Right? So the team's done a great job considering we virtually started from scratch and zero about twelve months ago. However, in order to kinda really build this out and do what we need to do, we need to find a way to be able to continue to invest in this business and make sure that we have the appropriate funding to do so. So let me pause there. Thank you very much for your your time. I think we're gonna open it up for questions. So, Mark, let me kick it back to you, and, we can start going through some of the q and a. That's great, Greg. Hans Peter. Jose, thank you very much indeed for updating investors. Ladies and gentlemen, please do continue to submit your questions using the q and a tab situated on the right hand corner of your screen. Just while the company take a few moments to review the questions submitted already, I'd like to remind you the recording of this presentation along with a copy of the slides and the published Q and A will be made available on the Investor Me company platform.

26:46 Greg, Hans Peter, Jose, I'll bring your cameras back up. You'll see those hopefully. Perfect. There we go. So as you know, investors pre submitted a number of questions, and thank you to everybody for their engagement, and there's been a considerable number of questions given the attendance on today's call. But perhaps if I may, Greg, just start with a a couple of the pre submitted questions. The first one reads as follows. Why did you take so long to release the final results, I e, six months after year end?

27:14 Good. Hans Peter, do mind commenting? Yes. Sure. There's really two primary well, there's one primary reason. But, you know, first of all, I'd like to remind everyone, we actually provided quite a bit of information already that that that you have seen in this RNS today back in February. February 17, I believe, is when we when we issued an RNS with trading updates. And I think quite a bit of of the results including revenues, profit, or loss have been included there already. Secondly, you'll appreciate that while we were in the midst of a financing process and and just recently completed, we just were not in a position to go ahead and provide an RNS update with our year end results.

27:53 We wanted to wait this this process up first, and then here we are providing you the information that that that we wanted to to to present. But I believe with the addition of some of the the 2022 highlights here in addition to that, hopefully, give some additional color in terms of, where we stand and what we can accomplish.

28:13 That's great. Thank you very much indeed, Hans Peter. Turning on to the second question, and and there are a number of these questions within the, live panel, so without having having to repeat those questions so so broadly for everybody. Would you require to raise monies in the next six to twelve months? What funding options do you have apart from an equity raise?

28:35 Can speak it again, please? Yeah. Sure. You know, like like all prudent company, particularly in the situation where we are, I mean, the numbers speak for for themselves. We obviously have, had contacts with a number of prospective investors and prospective partners again, look at strategic options, to to look at potential commercial opportunities. And where we have not been able to come to conclusion with anybody at least satisfactory terms and conditions, we'll certainly continue those discussions going forward. But but as we've presented and then reported here, with that bridge financing, we we hope to extend, and we expect to to extend our cash runway through the end of the calendar year. So we certainly continue those discussions and explore further opportunities. One thing, know obviously, everything is open and everything is a is a potential way to to secure additional funds.

29:26 But one thing that certainly for a company like us, without saying that we would necessarily look into that, but, you know, this type of drug in a ramp up situation where we're at, royalty based financing is certainly an option, and that's something that a lot of companies like us, like SHIELD, have been, capitalizing on in the past. So that's certainly one avenue we avenue we look at and we'll consider along with everything else that's on the table. That's great. Thank you, Hans Peter. Turning on to the next question, and we have again seen a number of questions throughout the live presentation regarding partnerships. But given the difficulties in scaling up in The US, should a partnership or out licensing model be revisited? Yeah. I'll I'll grab that one for you as well. No. I think, look. We are looking at a multiple multitude of different options. Right? I think as Hans Peter just mentioned, as a growing company now, with revenues coming in, we've got multiple financing options that we can be available to us and, you know, albeit admitting that the last, you know, couple of months across the board has been a very difficult time. Again, I think we're really happy with the agreement that we got in place.

30:30 We appreciate the support of AOP. So we've got multiple financing opportunities that we are actively going to look at as far as how do we capitalize the company and really fund this launch the way it should be. Right? And not the way it was, but the way it really should be overall. And then the second piece is the ways to kinda get there in terms of, you know, we can look at it as a SHIELD alone. We can look at this in a partnership overall. So, again, we're looking at every, you know, every opportunity that's out there in terms of how do we accelerate the voice of Acrefer? How do we get that out there and scale this up in a way that goes beyond just the 30 reps and the limited resources we've had to date? How do we really scale this up to drive that? Because what emboldens us right now is the feedback we're hearing consistently over and over again.

31:16 If we can get the attention of physicians and if they can hear about Acrefer, they understand what the issues are in the marketplace, there's a lot of interest there. Right? Now that just doesn't happen overnight. That requires a lot of resources, a lot of energy. You know, it's just not a one and done where you put a you know, somebody becomes aware of Acrefer. They hear it for the first time, and all of a sudden, they start writing the drug over and over again. It's It's just not the way that it works in pharmaceutical selling. You have to get back in front of them eight, nine, 10 times. Reps, marketing, different ways of messaging, medical affairs strategies overall, that full comprehensive effort needs to be done here, and we have not really scratched the surface across any of those. We're doing the absolute what we can with what we have, but, you know, we need to do and we should do more. Patients are out there waiting for us as well. So I think that's the opportunity we have. So I think we've got multiple things going on within our business of how to scale it up the right way, how to finance it the right way, and do so that can help create shareholder value.

32:18 So, Greg, this is Jose. And, Mike, if I may, basically, underline something that Greg was talking about from the perspective of the health care providers, the physicians and the patients. And I think there's a question actually in the chat in terms of what feedback do we have from the patients and the doctors. And, certainly, we have done a lot of work, like Greg mentioned, to create that awareness. When we get in front of physicians, and tell the story in terms of the data that we have to support the efficacy and the safety of the product, is basically very well received. Physicians understand that there's a unmet need. Physicians are looking for something new and a tool that they can use to treat their patients. Every single time that we tell the story to physicians that we get in front of those you know, physicians either through, medical education programs, advisory boards, one on ones, we hear the same feedback.

33:12 They understand that, you know, our discontinuation rate is less than five percent, in comparison to other oral salts, and the patients are basically satisfied with, you know, the problem as well because, you know, in many instances, they can't really, see the benefit of any oral supplementation because they don't stick stay on the product. So they're staying on Aquifer. They are seeing the product. They're seeing, you know, the efficacy of the product as early as four weeks in comparison to oral salts. So the feedback that we've received from physicians and patients that have been treated thus far is being extremely positive and encouraging for us because our clinical trial experience is translating to the clinical real world experience out there. Thank you very much indeed, Jose.

33:59 Greg, if I may just direct you to the chat on the the q and a panel on the right hand side. As you can see, there's a number of questions. If I may just ask you to read out any questions where you think you can give some further clarity, and then I'll pick up from you at the end. But if you could read out the question, that'd be most helpful. Yeah. That'd be great. So there's a couple questions in here about you know, comments on Norgine and just progress on China and things like that. And we obviously didn't have that in the the r and s outside of closing out the 2021 results, and, you know, we didn't update any progress there as well. But, you know, suffice it to say, we've been very active in our dialogue with Norgeen. I would say they are continuing to make progress. We're not putting out any financials now. We wanted to make sure we gave you a bit of a peek on what things are happening in The US, which is obviously the the big focus of our attention right now.

34:48 But what we've seen in Nordgene, I may have just said this before that we've had so I would say this. Our level of dialogue with Nordgene is at a far, far, far superior level to what it's ever been before, before my arrival. Right? So I think we are having very good open transparent discussions. Their markets, you know, and where they are in Germany and UK primarily, very similar to The US markets in terms of where the business is, where the opportunity is, and we've kinda pivoted to kinda more look in that direction and start to go after, you know, general practitioners of women's health versus just focusing on, say, GI. So we're starting to see some signs of success there. Obviously, we saw a 6% increase in pack sales second half of last year versus, first half overall, and, we're gonna continue to see that. By no means are we declaring any victory there.

35:35 There's a lot more that can and should be done, but we're actively in dialogue with them across the board. And then, Jose, would you mind just commenting on China for me real quick just in terms of, you know, how things are progressing there? Right now, just to remind everybody and to make clear, because I think there was a question as well in terms of sales from China. China is currently going through kind of the phase three development program. So they are enrolling patients in their phase three program. The phase three program, you know, is similar to the phase three program that we run-in to get approval in Europe and in US. You know, certainly, has not been necessarily very friendly with China, especially with some of the cities that have been on lockdown for some time. So certainly, there's been somewhat of a little bit delay there. But we're moving ahead and enrolling patients at this point. So certainly, we hope to continue to accelerate that in the months to come.

36:39 Good. Thank you. So there's a question here. Is the trend looking similar in growth for the second quarter?

36:47 So, obviously, we're not gonna be able to give you a lot of specifics there in terms of how things are going. We try to give you some insight of how the first quarter looks. I guess, the the best way qualitatively to say it is, we're pleased with what we're seeing as we go into the second quarter as well, right, without giving any real, metrics there. I think the work that we've seen that was initiated with the team, the trends we're seeing in q one, we're pleased with what's happening in the second quarter. We haven't got final numbers yet, obviously, as those are lagged, but, things are progressing in a good direction across the board there as well. And I think sets us on a nice track. And as I mentioned before, during the second quarter, we've hired about 12 new representatives, got them trained. They're out there now, starting to get their feet wet, getting in front of physicians. So we are counting on them to a degree to buttress the efforts of those 20 reps that have been out there really driving a lot of the business. Right? So if you hired the right people, trained them the right way, as we go into the third quarter, they should certainly help continue to lift the expectations that we have going forward there as well.

37:48 So so far, so good. Yeah. There's there's been a number of questions, if I might chime in, in terms of 2022 sales expectations, sales so far in 2022, when we're gonna be breakeven and so forth. And as Greg said, we cannot really give you specific guidance on those items. Obviously, we will report the half year results in the next few months as soon as we're able to do so. But what I can give you maybe is a little bit more color just in terms of what drives sales and and what we're focusing on. And and, obviously, as we reported before, the the number of prescriptions that you sell and the ramp up of prescription sales is obviously the key drivers, but that's not the only thing. The other thing that is is quite heavily impacting your future revenues during a ramp up phase is the amount of the the extent and how quickly you can get your payer coverage.

38:39 We obviously made some progress here. We reported that we that we have a 100,000,000 covered lives today. Let's keep in mind and put in focus that prior to December 2021, that was zero. We had no covered patients at that point. We started to to sign, and the first payer contracts came into effect in December 2021. So the revenue figures that we had reported in 2021 probably represent about 5% of the list price that we have for our product. And and so just as a reminder, perhaps it it's good to to let everybody know the the way pharmaceutical sales work in The US. For every product, you have a wholesale acquisition cost, a WAC price, or or list price, which in the case of Aquifer is $500. When you go and negotiate with payers, commercial payers, you effectively negotiated a discount.

39:30 And we believe as we started to launch the product that our future, hopefully, end game list price is around 50%. Net net sales price is about 50% of the list price. So say $250 per prescription. But until you get there, you start from a very, very low percentage of of your list price all the way to the $250, hopefully. Now for the contracts that we signed already, we feel very confident and encouraged that our estimate of an eventual final net sales price of $250 is reasonable, that this is very achievable. But right now, we're in this ramp up phase still where we have a mixture of product sales which are effectively still subsidized and some which are not. Now the total population of covered lives is 270,000,000 in The US. We currently have a 100,000,000 covered through our insurance coverage, so roughly 40% are covered. And we hope to increase that that percentage on an ongoing basis. And as a result, decrease the discount that we have to grant on our backlist price.

40:32 But if if you take both the ramp up of prescription sales and and what I just explained in terms of the increase, the continuous increase of net selling prices, you eventually get to to a a pretty significant ramp up. But we certainly hope that that will show once we report the 2022 figures both in half your reporting time as well as at year end. Very good. Thanks, Hans Peter. There's a couple of questions in here just related to AOP and the, the term sheet and the agreement that was signed and, you know, looks like, you know, maybe a little speculation of AOP's intent or what they may or may not wanna do overall. I'll answer the best I can, but, you know, suffice it to say, we've had a number of different conversations with AOP about, you know, our business, our aspirations, where we wanna go. They are incredibly supportive and believe in the asset, believe in the work that's being done here and are very, very happy with the progress. I can't comment, you know, some speculation on, you know, what their intent is to, you know, take over the company, whatever it may be overall. So, obviously, I can't speculate on what that may be other than to say that our conversations, discussions with them have been very productive, very supportive.

41:44 They've been a long term shareholder for us. We really appreciate them stepping up and helping out in this difficult market, but they believe in the opportunity. They believe in what we're doing here in The US, and they believe on where we can go here as well. So that's probably the the best way to try to, you put the the little, I guess, characterization on that on that commentary that I see in the the chat room here as well. There are a couple questions about just updates around q two and what are sales looking like, when we might update things as well. You know, Hans, if don't know if there's any, you know, comments there. I think, you know, certainly, we're not gonna we're gonna gonna try to provide as much timely updates as we can. You know, obviously, we'll have our half year results coming up here, at some point over the summertime. But any additional comments, Hans, Peter, from your side? No. It's exactly like you said. Obviously, we we try to, you know, be be proactive here and provide information as soon as possible, and certainly, we'll report these these half year results. I think in the past, that usually happened sometime in the month of August, and we certainly look to target around the same time frame again.

42:44 Yep. Good. Just looking to see here. There's a question, Hans Peter, from your comment around that gross to net discussion. Was that two fifty monthly or annual? It's actually on on a prescription basis. So one prescription is is thirty tablets that lasts for a month. So to to indirectly answer that question, it's on a monthly basis. So that does not incorporate any refills or new prescript follow-up prescriptions that would come from an initial sale. It's on a monthly per prescription basis. And there's a question that comes in around leveraging social channels to raise awareness amongst potential patients, you know, to support kind of a a pull strategy as well as a push approach. And it's a it's an excellent question, and that's part of that, you know, middle bucket I described in terms of how do we scale this and kinda get the word out there. Right? There's a multitude of different ways, right, that, you know, we're focused on physicians now, how do we create awareness, how to ensure they understand what Acrovert can do, and how do we get that Salesforce to to reach them, and how do we reach them in, you know, kinda nonpersonal ways.

43:48 The patient side is another very interesting angle. The team's really excited about what that could be, particularly in segments that we see some really good initial traction such as women's health. Right? So to give you a little color on that, you know, women's health has been, you know, a really interesting area for us because, you know, of all the physicians our our sales team is calling on, you know, probably about a third of the calls have been allocated towards, what I would call a women's health segment, and that's kinda OB GYNs as well as nurse practitioners and physician assistants that kinda specialize in that area. So, you know, we've made about a third of our total calls there, but almost half of our business comes out of that segment as well. So really good strong initial pickup. And, you know, the quote you saw from doctor Schulman is an OB GYN, I think, is indicative of that, whether it be, you know, menorrhagia, uterine fibroids, you know, other disease states. There's just a lot of women in The US that suffer from anemia, so that's a really fast growing segment. Dovetailing into a comment around, you know, kind of social media and maybe more direct to patient, you know, type of initiatives, we think that's a really, really rich area to explore. Right? So they think there's opportunity there both on the education physician side, certainly how to educate and make awareness of AcroVer on the patient side. We've heard that some of the research we did.

45:02 All that sounds great. Again, you know, we are, you know, trying to figure out how do we allocate the resources we have and where's the best spots to put those. Right? And, know, the challenge is we're sprinkling the infield a little bit here in terms of where we can kinda put that, but, you know, by no means are we scratching and really driving the full depth there. But that's really what we talk about when we think about, you know, partnerships, financing opportunities. That's how we take this up to that next level overall. And, you know, I think that's that's where we need to be. Right? The, the money that was raised initially, certainly, was a very good start. But if you look at any launch, you know, in The US across really any different disease state overall, the amount of funding you need, is to get things up and running and kinda get things moving at a steady state.

45:47 It's more than, you know, I think most people would appreciate. And that doesn't mean that you need to open up the floodgates and raise, you know, hundreds of millions of dollars. We have a very smart team that can be very efficient on that, but, you know, the team's been challenged in terms of resources to date in order to kinda get this thing where we need to be. I think we're coming up on time here. Let me just do a quick scan to see if there's any other big questions here. Hans, Peter, Jose, did you pick up anything on that side? I would I would like to add, you know, certainly, as you talk about women's health and some of the comments that we got from some of the advisers and the KOLs is that, you know, women in general, you know, have, you know, a prevalence of iron and iron deficiency at one in five. You know? And and women can be our customers in many ways for life because of the, you know, the different factors that come during the woman, you know, sugar years and, you know, uterine fibroids and, you know, postmenopausal that cause, you know, iron deficiency. So I think that's it's a very interesting segment. Like I do mentioned, we've been kind of, you know, honing on that and really on that and certainly, you know, focusing as part of our own strategy as well.

46:58 Very good. Hans Peter, anything else you picked up on the questions here to answer before we close things down? I think for the financial side, we picked up most of the questions here that I can answer at this time. Got it. Very good. I know there's a a number of questions marked on here that we weren't able to get to at the time, but we definitely won't go back and tell our get try to get responses out to each of you that has submitted additional questions here as we go through these. That that is very kind, Greg. And what we'll do is we'll make all the questions available, and thank you to everybody that has taken time both ahead of today's event and during today's event for your your engagement and your questions. Greg, on that basis, if I may, and I I know investor feedback will be particularly important to you. I will redirect investors after this closing comments, I guess. But if I may just ask you just for a few closing comments, and as I say, I'll I'll redirect investors to to give you their feedback.

47:50 Yeah. And thank you for that. And listen, first off, thank you for taking the time to, you know, join the conference today and hear that. I apologize We're not get able to get to every single question that was submitted, but, we appreciate the the interest there as well. And, look, you know, we are you know, on the one hand, we're sitting here, and I'm very, very bullish, and I remain bullish. Right? The reason we came here was about the product And what we hear again over and over again is the product is working. The feedback is great. The interest level is there with physicians overall. So those are all big gating items that, you know, when I was sitting it'd be a different story if I was sitting here today going, man, the product's not working the way it is, or, yeah, we're trying to get when we present it to doctors, they're looking at it and be like, you know what? No. There's no need for this thing. I don't see a need. It's everything is the exact opposite of that. It's like, this is great. This is what I've been looking for. This is what I wanna have.

48:44 This is an opportunity there. So, you know, on the one hand, we talk about how bullish we are and, you know, the sincerity there because it's backed up by what we hear on an everyday basis, and that's what motivates the team. Then on the other hand, you get the financial reality of, alright. How do we get this business to where it needs to get to overall? Right? And, you know, we gotta front then our mission right now is, you know, we see all the opportunity in front of us. That's what gets us excited. Then you get the reality of, like, alright. How do we get this business scaled? How do we fund it? How do we make sure we do this the right way that brings the value that we need to bring overall? You know, we're not blind to the market conditions that are out there right now, so we appreciate everybody's patience on that. But rest assured, this team is dedicated. We're excited about what we see. We have barely, barely scratched the surface, and we have options that are open in front of us, and that is our intent.

49:34 Right? Our intent here is know what's gonna happen the next month, what's gonna happen the next year, two years, and how do we build this business to build our first brand. So, again, thank you very much for your time, and your questions and your interest, and we look forward to keeping a better communication stream up with you as well. That's great, Greg. Hans, Peter, Jose, thank you very much indeed for your time and for updating investors this afternoon. Can I please ask investors on the call not to close the session as we'll now automatically redirect you for the opportunity to provide your feedback in order that the company can better understand your views and expectations? It's only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of SHIELD THERAPEUTICS PLC, we'd like to thank you for attending today's presentation. Good morning to all of you in The US, and good afternoon to you in The UK. Good