Shield Therapeutics (LSE:STX) — Interim Results

0:01 Good afternoon, ladies and gentlemen, and welcome to the SHIELD THERAPEUTICS PLC Interim Results Investor Presentation. Simply type in your question and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company review all questions submitted today, and we'll publish those responses where it's appropriate to do so. Before we begin, we would like to submit the following poll, and I'm sure the company would be most appreciative

0:31 of your participation. I'd now like to hand over to CEO, Greg Madison. Good afternoon, sir. Great. And thank you, and thank you, everybody, for joining us today for the investor presentation to our first half results for 2022. Obviously, there's a lot going on within your country over there and the and in England and wishing you all the best for what is to come here regarding the the Queen's Health, etcetera. But, again, we appreciate everybody dialing in and listening to the presentation today. We put out a release this morning, UK time. We're sitting here in our office in Boston, but we put our release UK time this morning about our first half results. I will go through those a bit in detail. And as noted here, we'll try to react to to as many questions as we possibly can at the conclusion of the presentation and look forward to the interactions here. So let's let's get started, if you will. So beyond the normal disclosure here, I think as we sat back and looked at the last twelve months, you know, it's been almost twelve months since we launched Aquifer in The US.

1:34 And looking at our organization, SHIELD THERAPEUTICS has certainly undergone a fairly dramatic and significant transformation during these past twelve months as we've kind of looked and put forward here launching Aquifer into The US from a commercial standpoint. And some of the the highlights listed here, you know, along that transformation, that journey really start to to draw that that point forward here. So we not only have developed, you know, our commercial strategy and launch plan of putting Acrefer into the hands of physicians here in The US and doing that on our own. We built a brand new leadership and commercial leadership team both on the ex executive side and the commercial side here in The US. We continue to expand all of our global partnerships. We're pretty enthusiastic about what those can bring. We are driving awareness, you know, to health care professionals here in The US about Acrefer hitting over 2,300 HCPs.

2:29 And last but so, initiated our phase three clinical trial, for pediatrics, both in The US as well as Europe, which could certainly expand our label going forward. So we are very happy and proud of what we've been able to accomplish in a relatively short period of time. And, again, we've undergone a fairly fairly dramatic and significant transformation, you know, both in appearance, but also internally here in how we operate and what we're trying to do. Now, importantly, while SHIELD has undergone this dramatic transformation and adaptation, the iron deficiency market, unfortunately, has stayed very much the same. And I say, unfortunately, for the patient side, because what we're talking about here, the good news for us is we look at a market like this here, particularly in The US. This is a market ripe for innovative disruption.

3:17 And what we mean by that is as follows. Number one, this is a very large and defined market. We've talked about this in the past, but there are twenty million patients with anemia, and they are all actively diagnosed and or treated by physicians every single day here in The US. And that's, displayed by the fact that there are 13,000,000 prescriptions written every single year in The US for patients suffering from iron deficiency anemia, and, again, primarily OTC or ferrous based irons, kind of the same old stuff over and over again. We know exactly where these patients are going to. Eighty percent of prescriptions are initiated by women's health, physicians as well as general practitioners. Right? So we know it's a large market. It's actively treated. Lot of prescriptions. We know who's prescribed them overall.

4:05 Yet this is a incredibly unsatisfied market. Unsatisfied and not and lacking in innovation. Right? There really has been no innovation on the oral iron side in decades. You have minor tweaks here and there, but they're all ferrous based compounds. It's the same old stuff overall. So what this has created is a lot of complacency in the market from a physician perspective overall. Right? We'll talk about what that looks like, but, you know, in their mind, there's no innovation here. They know they wanna use our oral irons. It's a very unsatisfied market. This market is sitting there. It's defined. It's big, and it's available. There is no real competition here, and Acrofor presents a chance to really disrupt and really encourage physicians that they should ask and seek more overall.

4:52 So what we see over and over again is depicted here where a patient walks in a physician's office overall. Most the majority of physicians are gonna start with an oral iron, and they write it. They get it to the patient. It's an OTC iron or a ferrous based iron, and it's the hope and pray strategy. They hope and pray that the product is gonna work. They hope it's gonna increase iron stores, and they hope and pray that the patient's not gonna develop some type of GI side effects. And onto the merry-go-round we go, and the patient really runs through this cycle of switches and discontinuations. And in essence, the patient's not getting treated for iron deficient anemia. In many ways, the results of the iron they're given are actually creating problems that are more challenging than the actual symptoms of iron deficiency anemia alone, and off and running we go. This is what's been going on here for the number of years overall, and we think we can offer more.

5:44 When physicians are asked, what does good look like? What do I want to see as a practicing physician and a patient? What do I wanna see in an oral iron that can help me? They want it to be well tolerated, effective, convenient, safe, and affordable. Right? Again, very clear, very straightforward. What we are very excited about is, again and again, we believe we have the product that physicians are looking for, that patients could be looking for. And, again, this product could absolutely disrupt this market, and what we need to do is kind of awaken the market. Right? Awaken physicians who have been so numbed by the fact that they prescribe oral iron. They hope and pray. They kinda think every iron is the same, and it's not the same. Aquifer is different. We think we've got a great a much better mousetrap, if you will, here, but we need to awaken the marketplace in many ways and let physicians experience and understand that they can and should expect more for their patients. Right? And ACRAVERS certainly can do that in a way that provides not just the effectiveness overall, but also the tolerability. So that that really what what drives each and every one of us here, you know, at SHIELD to get this pay this product out to as many patients as possible that keep big the the the thing we need to do is make sure that physicians are aware of it. Right? We've we've referenced that number of times here that, you know, they need to we have a great product, but physicians aren't aware of it. They don't know what exists out there, then they can't expect more. So I think all this speaks to the fact that this is a market that is ripe for disruption. If we do execute this the right way, it can create

7:16 significant value opportunities here across the board. Right? So not only significant revenue opportunity with a $2,200,000,000 market sitting there in front of us, again, limited competition. We have a great product overall, but this also if we execute right and drive the revenues where expect they can be, that creates value, you know, across the organization for, you know, not just the company, but our respective shareholders as well. Last but not least, we built an outstanding team. So if you look across the executive team and employ the commercial leadership team, this is a group that has profound US operational experience. They have experience with over 30 different drug launches here in The US. They know how to launch drugs. They know how to build brands. They know how to create that type of value we just talked about as well, and you've got a team here that is highly, highly motivated because we see we all see the same thing. That opportunity sits right in front of us with a marketplace that is yearning for a new type of product overall, but and, you know, the opportunity to kinda disrupt it and create this new market here.

8:21 So as we went into 2022, here's our priorities. Right? We talked about this, driving brand awareness, increasing prescriptions, generating that clinical experience, and expanding patient access to Acrefour. K? Three very clear distinct, you know, priorities overall. As we put out a release this morning, you know, when we talk about how we did during the first half of two thousand twenty two, here are some of the highlights, and we'll walk into a little bit more detail. So we generated over 11,000 total prescriptions written by health care professionals for Acrefer for patients suffering from iron deficiency anemia. We have over 1,000 brand new or first time prescribers of Acrefer during that period of time. Net net, that's a 350% increase overall in total prescriptions from the first half of two thousand twenty two as compared to the second half of two thousand and twenty one, and we had good strong sequential growth quarter to quarter as well. On a payer front, we've expanded our

9:15 coverage. We're up to a 100,000,000 covered lives overall, approximately 40% of all the lives that are available right now, so continue to make excellent progress there. And from a net revenue standpoint, we recorded $1,500,000 in net revenues on The US business during the first six months of the year. So we have made very, very good progress, you know, especially as you look at the six months of two thousand twenty two relative to the first six months of launch for the back half of twenty one. What's really impressive here and not listed on this slide, we have done this with a very small footprint of salespeople and a very limited marketing spend overall. So we are doing more with less when you compare ourselves to what other companies are normally doing at this point during their launch cycle. Let's dive into a little bit more details here. So this depicts overall total prescriptions written by US physicians.

10:05 This is done now on a quarterly basis. So you could see not only we talked about the 350% growth from the first half of this year versus second half of last year, but we're also experiencing very good strong sequential growth overall. So in the second quarter, we had an 87% increase in total prescriptions. That's following a 100% increase from q one to q two. Again, very, very pleased with the progression that we're seeing there. This really showcases the fact that, you know, we get out there. We start talking about Aquifer. There is demand out there. There is interest out there. There is a very large market out there as well, and we're starting to penetrate that nicely with our salespeople. As far as who is writing, we are getting half of our prescriptions today from women's

10:48 health, and about the other half is coming from general practitioners. So very much in line with where the market opportunity is across the board, whether it be general practitioners, OBGYNs, or nurse practitioners and physician assistants that kind of support those two areas. We're seeing a very strong consistent method there as well. From a new writer perspective, we had a very nice increase overall in the number of new writers. We had an 82% increase on the first half of two thousand twenty two versus the second half of two thousand and twenty one. Again, new writers are incredibly important for us. Right? Or first time prescribers is maybe the other way to to kind of describe this, if you will. And that's clear indicator that as they become aware of the product, the interest in the product, they gotta write that first prescription, and that's gonna be a critical part of our success.

11:36 We refer to it sometimes as breadth of prescribing, but getting more new writers is critically important for us, and we're making excellent progress in that regard. The other nice thing that we continue to hear is the clinical feedback from the product. Right? Whether it be from physicians or anecdotally from patients, that checkbox that I listed before of what do people want in an oral iron to treat their iron deficient ischemia, we are virtually checking all of those boxes currently. What's also nice here, I wanted to provide a little bit more detail is when we looked at our overall prescribers and looked at those physicians that actually wrote a prescription during the first quarter of two thousand and twenty two, eighty five percent of them also wrote another prescription during the second quarter of two thousand twenty two. Right? So getting them into this repeat prescriber mode is also an indicator that they wrote the product. They put a patient on it. The feedback was positive. It checked all the boxes, and they want to write again, and they are writing again. So that's the depth component that we need to drive here that not only when we introduce somebody to Acrofor to get them that clinical experience, but we wanna move them along the adoption scale so that they actually tend to write and look to Acrofor to be their oral iron of choice. So very good indicator for us there as well.

12:47 And on the payer side, again, we continue to make progress across the commercial plans, the Medicaid plans. We continue up to a hundred million lives or about forty percent overall coverage here. I think you noted in the press release as well with nice increase in our overall net selling price, which is also indicative of, you know, the coverage starting to take place. You know, we signed these contracts at the end of two thousand twenty one, and the coverage started to kick in in 2022. So not only are patients now starting to come online here, and we have prescriptions written here, but it's actually influencing our net selling price and our overall revenues as well. So shifting off The US, you know, onto Europe and our partnerships here as well. From a Nord team perspective, you see depicted below, the graphic that indicates the number of packs that are sold in Europe. Obviously, we're prohibited from telling what the numbers are, but you can see what the incremental growth looks like there. And I would say right now from a Nord team perspective, they're on a fairly steady growth period. What's really important to note here, however, is this is all driven off the GI call point. Right? So Nordion has been very, very focused on GI as their kind of primary call point overall.

13:55 They've generated, you know, some, I think, decent growth overall, but certainly not nearly the level of what I think we would expect or that the the market can expect here as well. What's really encouraging is that Nordgene's undergone, you know, quite a bit of, of change, you know, as a shield. We've transformed ourselves quite a bit in the last twelve months. Nordgene's actually undergone a fairly significant change as well. And, you've got some, new fresh thinking in there, particularly on the commercial side, which is very encouraging for us. What's really nice is that a conversation back, you know, probably about six, seven weeks ago with the woman that's running their commercial overall, and she looked at The US marketplace and understanding that most of our business and the opportunity resides in women's health and general practitioners, she's very keen to kinda look at adapting, you know, what they're doing right now because they really want and both Germany, UK, and others to really develop

14:46 and grow. So they are very, very interested in looking at what we are doing in The US. They're actively analyzing that opportunity with making plans in 2023 to potentially shift their allocation of resources towards those big call points. So, really, the markets aren't that different from the side look at it. You know, both in Germany and UK, a lot of the online business gets generated by those two particular specialties. Again, if we stay in the GI space from a Nordium perspective, I think we'll expect to see incremental growth as depicted here. But if we wanna really kick that up and take advantage of the opportunity, I think they need to, think about shifting their, their strategy. And the good news is we're finally having some more engaging discussions around that side, so more to come on the the NordGen side. Additionally, from a global perspective, all of our partnerships continue to progress along very, very nicely.

15:37 In China, we continue to roll the phase three study. We put out a press release around CHI Pharmaceuticals earlier this year that they've submitted their regulatory package to the to the agency. We expect

15:49 that that approval time line could be the middle part of 2023. And then Korea Pharma definitely is continuing to engage with the regulatory authorities. We expect to get an update from that soon on what that pathway looks like towards getting approval. And each of these come with a variety of different sales milestones, approval milestones, and royalties on the back end as well. So it's continued to progress very nicely for us. From the financial perspective, let me pause. I'll turn it over to Hans Peter Rudolf, if wouldn't mind running through the some of the financials. Sure. Thank you, Greg. From a financial point of view, I'd like to focus on three areas that were included in the release this morning. First of all, revenues. We have reported £2,000,000 of revenues for the first half of twenty twenty two.

16:35 Of that amount, roughly 60% or £1,200,000 were generated from US net product sales, £700,000 from royalties from our European partner, Norgeen, and the balance of £100,000 from an upfront payment from our new partner, Kai Pharma, in Canada.

16:56 In the comparative period in the first half of last year, SHIELD reported £500,000, all of which were generated from royalties by Nordgene. Obviously, we had not yet launched our product in The US at that point. Two, in terms of bottom line results, the first half of twenty twenty two yielded a net loss of £11,800,000 compared to a loss of £7,300,000 for the first half of twenty twenty one. The increase in the loss can be directly attributed to the increased operating costs, particularly selling costs, which make up £7,700,000 or 65% of the operating costs of £11,900,000. In comparison, last year, the first half of twenty twenty one, prior to the launch of Aquifer in The US, selling costs were merely £2,200,000 or 36% of the total operating costs of £6,100,000.

17:55 And then number three, the company had a net cash balance of £2,400,000 at 06/30/2022, which is down from £12,100,000 at the prior year end, 12/31/2021. This results in a monthly average net cash burn during the first half of twenty twenty two of £1,600,000. I also like to point out a separately reported a few weeks ago, SHIELD had finalized a convertible loan agreement with an existing shareholder for $10,000,000 effective 08/01/2022.

18:33 This share shareholder loan led to a net cash balance of £8,200,000 at the end of August twenty twenty two, and it is expected to extend the company's cash runway through the end of the current year. Back to you, Greg. Very good. Thank you, Hans Peter. So all in all, if we kind of reflect on where we came from, back twelve months ago, but briefly focus on the first half of twenty twenty two, which we announced this morning, we have built a very strong and solid foundation here at SHIELD and with our business of Acrofor in The US. We are seeing increasing prescriptions, an increase in first time prescribers, an increase in repeat prescribers, awareness and growth are expanding, payer coverage is growing, and we have a positive clinical experience generated right now. So if there's a proverbial scorecard, we're very, very pleased with a lot of these, what I call leading indicators. Right? As you're running the business and you're launching a drug where, know, you have, you know, limited spend, small team, no awareness going into it, every single indicator that I wanna see is being generated and moving in the right direction here. And, again, it doesn't it goes

19:42 it's a it's an important point to note that, you know, this small team of 30 people, we've listed here a modest marketing spend. I would say it's a low marketing spend relative to what others do during their launch and limited cable engagement. We're very pleased with where we progressed to. However, there is so much more that we can do. You know, we go back to that first slide and think about the market disruption, the way to go after this market. It is literally sitting right in front of us, and, you know, we're happy with the progress we've made, but there is a lot more that we can and will and intend to do. The drivers to be able to accomplish that. Right? So this is important here. It's like we think about how do we accelerate growth? How do we turn this brand into the hundreds of millions of dollar brand that we expect it can be and really reach our full ambition? There are three primary ways we need to do this. Number one, we need to expand our field force.

20:31 Number two, we need to really step up and amplify our digital strategy and marketing initiatives. Number three, we need to increase our KOL engagement and support our data generation across the board here. So we've got a small team, you know, limited resources, and, however, we've created a very strong proof of concept here that there's a market, there is interest,

20:53 there are prescriptions being done, we're getting payer coverage, so we need to scale this business overall. Right? For kinda operating on small scale right now, the goal is we have to scale this business and do it in a most efficient and economical way that can really recognize and drive the value we expect overall. So it really leads to the question of, like, so how? How do we maximize the opportunity here, overall? Right? And, clearly, you know, in order to do this, we need to kinda finance the company and get onto our front foot here and really start to drive a lot of these initiatives that we talk about here as well. As we sit here today, we are very, very reliant on our 30 salespeople. There's really not a lot that's going on around them, unfortunately, at this point in time, and we can do a lot more. And the importance of that is, look, you've You got a salesperson that goes into an office.

21:40 When they can get in front of the doctor, they engage. They can create that interest overall. When that salesperson leaves the office and, you know, it's two weeks, three weeks before they get back in or sometimes it might be months before they get back in, In between that, you have to have other

21:55 ways that physicians are hearing and hearing about Aquifer. It could be congress presence. It could be digital online, you know, opportunities. There's a number of different ways that physicians who wanna keep Aquifer front of mind, keep that in front of them overall, and that's really the way that the pharma business is driven right now, and that's how you drive success. We are overly reliant on the ability of our reps to get in front of a doctor and really drive that awareness overall. So first and foremost, we need to finance the company as a growing organization with revenue starting to increase, our prescriptions increasing as well. We feel like

22:27 this is a very, very investable business to be able to scale that up overall, we are pursuing a number of different opportunities in that regard. The other things we're looking at is more on the business development side and kind of strategic partnership side that alongside as we're pursuing the different financial opportunities, is there another way we can scale this business? Right? Is there another way that, yeah, we can look at it creatively to think about, alright, what can SHIELD do, or is there another, organization that could work alongside us or with us, whatever it may be, to help scale this business? But bottom line, we have to be able to scale this business in order to really capture the full value that AcroFit can bring, the full value that can be then translated to SHIELD, and the full value that you can get then get translated over to our shareholders. And rest assured, we're pursuing that in a number of different ways. And bottom line is we're performing well, but we wanna do so much more. And the team here is motivated to do so much more.

23:21 So, really, it's all about taking advantages, act for opportunity. If we execute this well, there's tremendous revenue potential. Just remember, it's value creation potential overall. And we mentioned before, this market is just ripe for this disruption. Large market, but very unsatisfied. We've got a best in class product. There's limited competition. We have a long IP runway, and you've got a team in place that knows how to do this and knows how to build brands and, be successful launches. So with that, that'll, end the the prepared, parts of the presentation. So we'll now open it up to Q and A. Just give me one second here so I can scan through the list of questions and make sure that we've got a couple of those to go. That's great, Greg. Let me just jump in and give you a few moments anyway. So thank you once again for your presentation.

24:06 Ladies and gentlemen, Please do continue to submit your questions using the Q and A tab just on the right hand corner of your screen. Just while Greg and the team take a few moments to review your questions submitted today, I'd like to remind you that a recording of this presentation, along with a copy of the slides and the published Q and A, will be available via your Investor Meet company dashboard, and we'll notify you when that's ready for your review. Greg, I know I haven't given you any time at all perhaps. But if I may, hand back to you. If I could ask you to read out any of the questions and give a response where it's appropriate to do so, and then I'll pick up from you at the end. Absolutely. Yeah. I'm gonna join. I've got Hans Peter and Jose here as well. So I'll kinda quarterback this, if you will, and fill some questions and get the questions off to to some of them as well. So, Peter, there's a a question here listed on

24:51 in the press release. Excuse me. There was a a note on the net selling price, how that's increased, you know, from first half of twenty two versus last half of twenty one. Would you mind just commenting on that and how that affects, you know, ties in the payer coverage side? Sure. Yes. Specifically, we disclosed in in the release was that in the second half of twenty twenty one, so the first half after the launch, our net selling price for the product was around $35 in The US, and that increased in the first half of twenty twenty two to a 150, $354. Obviously, a very substantial increase, but I think we need to really take a little bit of a step back. It's certainly very good news, and we're we're, at the moment, very pleased with the net selling price average net selling price of over a $150.

25:39 But the the way it works really, the net selling price is a is a formula of both distribution costs and the rebates discounts that you grant to various payers. And, obviously, a mix too of how many of your products that you sell are effectively covered through covered lives by payers versus others that you have to subsidize yourself by patients who are not insured at this point in time. So what you see, obviously, is a significant increase. And when you put that in perspective, last year in 2021, most of the payer contracts that we were able to negotiate only came into effect effective December, so the very, very end of that half year, which means a majority or at least five months' of sales were effectively subsidized by the company. It was important to sell these products and create awareness about the product to make writers and patients used about the opportunity of of what I prefer.

26:34 But we obviously did not earn a lot of money on it as a result of the fact that little payer coverage was available. That changed rapidly, obviously. And and for most of the payer contracts that we did sign, those were in fact towards the end of twenty twenty one, and thus the increased net sales price for 2022. Going forward, we hope to increase further increase net net selling price, and and, ultimately, we hope to get somewhere in the range of 200, $250. Certainly, $250 is what we believe could be a reasonable target. How quickly that will be achieved is very difficult to say because negotiations with new payers and existing payers continues on. Sometimes you can improve on an existing contract. And and, obviously, if we wanted to, we could get a lot more payers on board today.

27:23 The problem is what price can we achieve for that and how much potential upside on product revenue do you want to sacrifice in order to get deeper payer coverage. So in other words, we need to make sure until payers are actually willing to agree on a reasonable rebate results. And in that point in time, we can sign up additional payers as well and hopefully then thus improve the net sales price going forward. Very good. Yeah. You hit one question. Was on here too around expanding payer coverage. I think you just alluded to that. Like, we're very keen to continue to expand our payer coverage. We're very pleased with contracts we have right now. The goal right now is to drive demand. Right? We need to be able to drive demand, and as Hans Peter alluded to, you know, there are payers out there that we'd like to get, where we need to have a reasonable discussion to make sure that it works from both sides, right, and not having one-sided arrangement. You know, it doesn't do us any good to kinda just work on focusing and increasing payer coverage. If it's gonna cost the business significantly, we're not gonna do that. Right? We're gonna run this business the way that we expect we should, and that's how we're gonna proceed forward here as well. So excellent question.

28:26 There's a question here. I'll field it as well that we're seeing. I think it's early September. We're sitting right now as a question of, like, hey. Can you give us an update on July and August?

28:35 The short answer is no. We're gonna do this on a quarterly basis. We're not gonna get into a a month to month discussion of how things are progressing here as well. The other reason, just to give a little insight, is we don't have the final data for August yet, for example. Right? So, you know, we don't get prescriptions. So prescription data, you know, here in The US, all the data reports are lagged significantly. So they're up to a month later is when we actually get the final final data. So we certainly do not wanna do is put half baked data out there into the marketplace. We normally wanna do this on a monthly basis, so just some color and context that, again, we're gonna continue to monitor things, report on, you know, quarterly or half year basis as we've been doing right now. But, you know, part of the reason is we just simply can't provide real time updates within a month even though we're eight days into September. We don't have August closed just yet. Okay?

29:22 Hans, we know there's a number of questions around financing as expected. Right? That's obviously a critically important point for us. We have great aspirations. We believe this is an investable business. Like, you have questions on, you know, just financing in terms of how or what options were available to us, and perhaps you could expand on that a little bit. Sure. Happy to do so. Obviously, it it goes without saying that management continues to consider various options for financing, and we we you know, obviously, based on the cash runway, the need for additional financing is is very evident. What form, timing, and amount that financing will take is currently still under discussion, but we certainly consider both potentially dilutive as well as nondilutive financing options. That could be in the form of straight debt. It could be in the form of of royalty financing, which is something that actually could be very interesting for the product that we have right here.

30:14 There is some future cash flows that we can predict here. This, you know, more or less is certainty, but the the the additional foundation that has been set in the first twelve months since the launch is certainly promising that revenues would further ramp up and eventually lead to positive cash flows, and that could be attractive to potential royalty lender. So we believe that's a very, very viable option for us to pursue going forward. In addition to that, we also don't rule out a dilutive financing potentially looking into an an equity raise, which we obviously attempted a few months back already, but unfortunately, to the adverse market conditions, was not successful ultimately. But we haven't given up that that that that thought. And if we pursue that route, that will we'll certainly make that public to to everyone, to existing shareholders as well as to prospective new shareholders.

31:06 We feel if there is an equity raise, it would only make sense for us to consider potentially make this available to a wider audience as well. Good. Just scanning the questions here. Look. I think from a financing perspective, what's critical for us is that we continue to expand and grow our business. As mentioned before, you know, we are know, we're operating at a, I'd say, relatively small scale at this point. You know, if you go back and folks on the phone may not be aware of this. We look at U US launch launches into The US even from a small company perspective overall. Our level of s g and a spend that we do really is dramatically lower than even the low end of companies that launch out there in The US. So we are definitely doing more with less, but but that's that's not gonna get us to where we need to get to overall. Right? So as I look at our business, you know, the questions commonly asked or should be asked is, is there a market? Yes.

32:01 Is there an opportunity? Yes. Are there competitors in the market or coming down the road? No. We don't foresee any real, you know, competition in this market right now. You know, do we need to, you know, invest additional resources to get in this market? Of course, we do. Right? And I'd like to just get to the to the low end of average, you know, versus what we're operating on now. Our s g and a spend has been 5,500,000 the last two quarters consecutively. And you look at other companies, it's dramatically higher than that. Right? So we're gonna continue to manage our resources very efficiently as we've done and very effectively. We got a team that knows how to do that as well, or certainly that scaling of the business is critical. And I think we feel confident that there's an ability to get this business invested in particularly with the trends that we see right now, the options that are sitting there in front of us as Hans Peter alluded to. We've got dilutive options, nondilutive options. We're gonna manage this thing very, very carefully to ensure that, you know, we do what we need to do to run the business, but I'll keep also keep an eye on what's important and valuable for, you know, all of us as shareholders in this business as well. So I think there's a, you know, tremendous opportunity there for us going forward.

33:05 Jose, I'm gonna toss one over to you. There was a question around, you know, awareness building and some of the exposure that, physicians have had. Just from a clinical feedback perspective, you know, what are you hearing and seeing out there? Any changes that, you've noted? Thank you, Greg. You know, certainly, from the awareness perspective of the physicians and providers there, we've been working to really, you know, accelerate and expand that as you presented earlier. The feedback that we're getting from patients and also physicians is very positive in terms of the clinical experience. I mean, the clinical experience that we're seeing in the field is kinda translated very similar to the clinical experience that we sell in the clinical trials. So, anecdotally, at this point, certainly very positive.

33:53 As we continue to move forward and as you mentioned as well, one of the areas that we need to span is continue to generate more data to continue to basically inform the providers and the patients on the efficacy and the safety of the product and doing that through, you know, real world evidence. And we're looking at the many different options in the future to execute on that. But in general, the the the clinical experience and the attitude relate related to the product has been very positive. Good. Excellent. Alright. Give me a minute here to look. There's a question on if we are pursuing deals outside in other countries such as Japan. So, yeah, I think on a business development side, if we look at global partnerships, again, we've made really nice progress, over the last, twelve months here in certain other areas.

34:49 We're gonna continue to look for opportunities. Right? So Japan's an opportunity. There's a market there much as we see here in The US, then, absolutely, we'll pursue that and, look to find some partnerships here wherever Wherever we feel like there's an opportunity to, you know, get ACREFER in the hands of patients that are in need of it, but also do it in a smart way from a business perspective, we'll definitely continue to, to keep an eye out for those opportunities. Yeah. I've noticed a couple questions too that point toward the question about the direction when we expect to reach cash flow breakeven or profitability. And, you know, I I think those are obviously important metrics and important targets that the management team is aware of, but it might not be the only metric that we need to keep in mind. And it's it's very typical for small pharmaceutical companies to really measure the potential of a drug by how quickly you could ramp up your your revenues, your sales, and effectively show that the peak sales that you forecast for a particular medicine is actually achievable, in the time that you have until the end of patent protection. So there is a a very fine balance between trying to move toward breakeven point for cash and profitability and trying to reinvest some of the funds into further building out your commercial activities and and thus increase your your your gross in in net sales. And we we try to walk this line. So the question that has been asked here is very difficult to answer, and only time will tell. For us, it is important

36:20 that we could show continued growth in the sales activities. And as such, we need to have that balance and also invest in the commercial activities with some of the cash flow that we could generate going forward. Yeah. I think that's critical. Right now, revenue increasing prescription revenue generation is primary job one, period. Period. And that's what's gonna really create the the market, you know, as far as, you know, at some point, harvesting those sales and, you know, turning more towards profitability and figure out how to efficiently do that. You know, we're not that's not a near term goal for us. Our goal right now is going after those 13,000,000 prescriptions written every single year, and we are virtually just scratching the surface of what we can and wanna do. If there's a if there's any frustration that we experience is we see the market. We see the potential. We've seen the feedback, but, you know, we're doing this in a way that, you know, in some ways, we get both hands tied behind our back because we're doing it with a small, dedicated, motivated team here with limited resources, and we see the opportunity. And this isn't, again, somebody that's sitting here saying, hey. Give me more money, and we'll do a better job.

37:26 We're doing a great job of what we have, but there's so much more we can do. If we wanna turn this into the business we expect it to be, man, there is so much potential here, and we do not wanna see that wasted. That's really what we wanna do. We do firmly believe that dollars invested in this business will pay off significantly, and that's our goal right now in the short term. So we're happy with the progress we've made. We gotta get the company financed. I do believe we can get the company financed with the opportunity we see in front of us, and then we're ready to roll on our side. So, I think let me see if there's any other popped up questions that are worth hitting here. Let's see. You mentioned there's a question here.

38:18 87% of prescribers are writing second prescriptions. Any insight to those that are not? Any common themes on negative feedback from prescribers? Yep. Leave it to figure out, like, the 13% that aren't writing versus focusing on the 87% that aren't writing. That's a really, really good score. So I'm not gonna comment on, you know, why somebody maybe not written, maybe they didn't see a patient during that period of time. I'm not sure. But to have eighty seven percent of of physicians who wrote a product in q one do that again in q two, that is phenomenal. Right? And that's our focus. So we should be really, really happy with that. We really haven't heard any negative clinical feedback on the drug. Right? So we finally get the chance. If one of our reps can get in front of a physician and actually talk to them about the drug, rarely do we hear, no. Not buying it. Don't like it. Clinically, it doesn't make sense to me. It's the opposite. It's like, great. Everything looks good. If there's a question or a comment, it usually is a, hey. How do I get it, and how much is it gonna cost my patient? That's really the the main drivers here.

39:19 So there are patients out there that either you're uninsured or don't have insurance, if there's a reason somebody may not write it or a particular patient may not get it, it usually is going to do with more of a cost to the patient overall. We've got a lot of different protections around that can be, but it's not a 100%. So I think, clinically, we feel really good about the feedback we've heard, and we're gonna continue to work on that. And, again, it's all about how we continue to drive more physicians to become aware of back refer, how to drive more prescriptions in the funnel, and the opportunity is sitting there right in front us. I think you need to combine that, you know, Greg, with the fivefold increase of new writers from q one to q two. I think that as we continue to create awareness, as people continue to learn about Aquifer, as people start to really kind of prescribe it for the first time, you know, certainly, they wanna see the experience of the patient to write it again. And I think that it takes time. You know, we have a new, you know, five fold increase of new writers in q one to q two. We had a lot of repeat, you know, riders that we saw 87% in q two. I think that's great.

40:22 But, certainly, you know, those patients have to come back. Those patients have to provide their experience to the patient and to the physician. The the physician have to see the effect of it of the product. And as you mentioned before, once the physician knows about the product, one the physician, you know, is is introduced to the product, and they prescribe it. And then once the patient start on the product, they continue the product that we have seen. So I think it's a combination of both both factors that will come into effect moving forward. Yeah. Good. Thank you for that. Yes. For us, it's twofold. One, happy with what we have. Number two, we gotta scale the business. Right? And that's really the the goal there that ties directly into the financing side. So is this an investable business? We believe it absolutely is.

41:09 If we can secure the financing, or shall I say, when we secure the financing overall, we believe that there's a dramatic opportunity here, and that's our really focus and goal. And, also, bear in mind, we're actively pursuing not just financing opportunities, but other strategic opportunities as well. Right? So there's different ways you can scale your business and get it to a level that you really want it to be at overall. You can do that in, you know, kinda sections or transitions over time. You know, there may be opportunities with business partners that can help us get there faster. So all those things are being actively pursued as we speak right now. And, again, the nice thing is we believe we've established a very, very solid and strong foundation from what we can believe at, and that provides a lot of attractiveness because, again, this is no longer a proof of concept type of approach, if you will. We've established this market. There's a need. There's coverage, and we can execute on that side as well. Now, again, we just need to scale that business. So that's what the team here is hard to look at.

42:06 So I think, Mark, that's it that I see from questions here. I think we can kinda wrap it up if you want. No. That's no problem, Greg, at all. And, of course, any further questions that come in, we'll make those available to you post the meeting anyway. I think you've very nicely summarized the position of the company. And maybe, Greg, if there are any further comments, please feel free to share them. If not, I'll redirect investors to give feedback, which I know is particularly important to you and the rest of the board. Nope. Again, thank you guys and gals for your interest and the time on the, the call today. We'll look forward to keeping you updated on our progress. And, you know, as soon as we have additional news, you'll be the, the first to hear about it. That's great. Greg, handspeak to Jose. Thank you very much indeed for your time this afternoon and for updating investors. Could I please ask investors not to close the session as we'll now automatically redirect you for the opportunity to provide your feedback in order the company can better understand your views and expectations?

42:58 This 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 at SHIELD THERAPEUTICS, thank you very much indeed for attending today's presentation. Good afternoon to you all.