Shield Therapeutics plc (STX) Earnings Call Transcript & Summary
September 4, 2024
Earnings Call Speaker Segments
Operator
operatorGood afternoon, and welcome to the Shield Therapeutics plc investor presentation. [Operator Instructions] Before we begin, I'd like to submit the following poll. And I'd now like to hand you over to the management team from Shield Therapeutics plc. Anders, good afternoon, sir.
Anders Lundstrom
executiveThank you so much. Thank you so much, and a warm welcome to all of you to our presentation of the first half 2024 interim financials. So my name is Anders Lundstrom. I'm the Interim CEO since end of July of this year. By way of background, I've been in the pharmaceutical industry for over 35 years, half of the time in Europe and the last 18 years here in the U.S. Important to note is that I've been on the Board for Shield Therapeutics for over 3.5 years, so since the setup of the commercial operations here in the U.S. and our initiation of the collaboration with Viatris about 5 quarters ago. My role on the Board is to be the commercialization expert, although also I've been a CEO for a public traded company before. With me today is Santosh Shanbhag, our CFO, and I will let Santosh introduce himself.
Santosh Shanbhag
executiveThank you, Anders. Hello, everyone. As Anders said, my name is Santosh Shanbhag, I'm the CFO. I've been with the company since the start of the year, and I'm excited about the growth that we are seeing today as well as potential growth in the future. Been in the industry for about a couple of decades right now. Prior to coming into Shield, I was the CFO of a public company here in the U.S. We took them public here. We were a leading digital therapeutic company. And prior to that, I spent about a decade at Vertex Pharmaceuticals, both here in the U.S., leading their finance teams, as well as the CFO of the international business out of Europe based out of U.K. responsible for Europe, Australia and Latin America. Looking forward to this discussion today.
Anders Lundstrom
executiveThank you, Santosh. Here's the disclaimer. So now everyone, everybody read that, let's just move into today's presentation. So today's presentation is divided in 2 parts before we come to your questions. So I will start by presenting the opportunity in the iron deficiency with or without anemia market. And Santosh will follow up with our first half financials. And as I said, then we will take your pre-submitted questions. So let me then just introduce you to Shield Therapeutics. So Shield, we operate, as I said, in the iron deficiency market. It's a very big market. And I'll come back and show you some numbers so you can get the feel for the size of the market here in the U.S. Our reason for being is that most traditional oral iron salts often leads to discontinuation because they irritate your stomach. You do get actually tolerability problem and stomach side effects, and thereby, they stop taking their therapy, and also leading to insufficient efficacy. So ACCRUFeR, as the brand name here is here in the U.S. or FeRACCRU as it is ex-U.S., in Europe is the only -- well, it's FDA approved, it's approved in Europe, and now by Health Canada, has a very broad indication for use in adults suffering from iron deficiency with or without anemia. We are lucky to have a very experienced executive team with extensive U.S. commercialization expertise, but also expertise with cost of manufacturing, regulatory, R&D and so forth. And I have a slide describing that for you as well. As I said, we are co-commercializing in the U.S. with Viatris. And that has really catalyzed our commercial expansion and growth for ACCRUFeR in the U.S. And we're lucky to have such an established company as our partner when we are on the journey and here on the U.S. market. We estimate the peak revenue potential of ACCRUFeR to be around $450 million. And I'll show you some numbers later on in the presentation so you see how we come to such a large number. And very importantly, we have very strong intellectual properties through 2035. So this is the management team where -- so Santosh and myself, and Lucy and Andy are stationed here in the U.S., and David and Jackie are in our Newcastle office. So we're spread across both countries, and then we cover different things, as you see. And we're very -- as I said, we're very fortunate to have such a strong experience and capable management team to lead our efforts. And as we are a small company, many of us wear many different hats. So iron deficiency, it's very common and can be serious condition, and that has a significant impact on patient's quality of life. So as you can see, symptoms can be that you feel very tired, you have headache, you're dizzy, and you can even suffer from cognitive impairment. It's most common in women of childbearing age and also in patients with inflammatory conditions such as Crohn's disease or ulcerative colitis. And it can be caused, as you can see on the slide, by malnutrition, malabsorption or bleeding. To describe the problem for you a little bit is that most oral iron salts, as I said initially, they dissociate in the stomach. And that leads to that -- they irritate the stomach lining. And that is where the gastrointestinal side effects appear. What happens then is that quite large portion of the patients cannot tolerate this and they stop therapy. So of course, if they stop therapy, the therapy wouldn't do what it's supposed to do. So that is where we come into play. So our solution is a very elegant solution on how to avoid these gastrointestinal side effects. By having the actual iron protected by a maltol shield. So it can pass through the stomach and be released and absorbed in the small intestine instead. That gives us a very nice place segment in the market. So many of these patients have tried other oral iron salts before, either -- typically many are available as OTC products. And since they don't work, they try them again, and they don't work, they try them again. And before everything -- it can get very serious and then you would need an IV infusion. But we are sort of smack in the middle there. And as I said, our reason to be is that our product, ACCRUFeR or FeRACCRU is very well tolerated. It also effectively normalizes and maintains hemoglobin levels. So this position, having the position we have, presents a large market opportunity, and I'll share that in a few slides when I describe the U.S. market opportunity for you. Well, let's -- before we get there, let me share with you where do we have our global partnerships and how do we continue to progress. I'll come back to Viatris, and I mentioned it already. We have since a year a 100% sales force here in the U.S. And what we do here? Here we have a revenue-sharing agreement and we also have some milestone at revenue levels that we can collect in the future as well. So that's the U.S. market, and I'll come back to that more in a little bit. In Europe, we have Norgine as our partner. And as you will see soon from the number, they continue to do well. They've done really well the first half of this year. Here we get royalties, and we have a milestone payment upon the approval of the pediatric label in Europe as well. In Canada, we have Kye Pharmaceuticals. They just got approved, which we're really, really happy about. And Canada is a significant market. I used to say that Canada compared to the U.S. is, of course, very small. But if you compare Canada to the top markets in U.S. -- in Europe, I mean, sorry, it would typically be ranked sixth or seventh. So it is a significant market opportunity. Here again, we have revenue-based milestones payments and double-digit royalties on net sales. In Korea, we filed an application we know is being reviewed. And if everything goes well, which we, of course, hope it will do, we anticipate an approval next year in 2025. Same set up here. We have royalties in the mid-teens on net sales. And then in China, finally, we have a Phase III study ongoing. We hope that study concludes late this year or very, very early next year. We can file then in 2025 and expect an approval in the second half of 2026. Again, the same setup with a Chinese partner. We have approval milestones, we have double-digit royalties on net sales. And now then to the U.S. So we are co-commercializing in the U.S. with Viatris, and I also would give you a sense over the size of the market here. So there are -- estimate is about 20 million individuals have iron deficiency. It's a large and well-defined market, and we see about 12 million prescriptions per year. And the great majority of these prescriptions are then prescribed by either a practitioner or by OB/GYN specialists. So at this moment in time, we are in the dark blue circle, we call, current. So we call on about 12,500 HCPs, and they represent about 1.8 million prescriptions. So as you can see there, we have about 3% market share in that market segment. So there's a lot more we can achieve already where we are sort of focusing right now. What we call the expanded market is the market where we see that we can go in the future, which is, you can see that half of the addressable market are in expanded market with 6 million yearly prescription out of the 12 million in total. And this segment has about 50,000 HCPs. And that is something we could reach when we expand the business further in the future. And this is the rationale and background how we can get to our sales potential, which is around $450 million a year. So by that, let us continue with the first half year financials with Santosh.
Santosh Shanbhag
executiveThank you, Anders. I'll go through the details of the press release from this morning. As you can see on this slide, we have got 3 key big priorities. The first one, obviously, is growing ACCRUFeR here in the U.S. on all 3 fronts: revenues, prescriptions and gross to net, making sure that we have a strong balance sheet and backed financially to support our near-term and long-term growth, and then obviously making sure that ferric maltol is available to patients across the globe, especially through the partnerships that we have in different geographies. On the very first bubble there, the growth in ACCRUFeR, we reported this morning $11 million ACCRUFeR net revenues in the first half of this year. Now that represents about a 3.5x growth compared to the first half of last year. Obviously, ACCRUFeR, the growth in revenues is driven by 2 elements: the demand as well as the pricing. On the demand side, we reported 65,200 prescriptions for the first half. Now that represents about a 25% quarterly growth since the launch of the product with Viatris earlier last year, in the first half of last year, where we had 100 reps in the field. On the pricing side, we reported first half of $158 net price realized per prescription. Now that's a 33% growth versus the first half of last year. And that continues to grow steadily on a quarterly basis. As an example there, you can see in Q2 of '24, it was $171, compared to the $158 that you saw for the full first half. From a balance sheet perspective, we exited the quarter, Q2, with $8.1 million cash and cash equivalent on hand. We have implemented an accounts receivable financing that's already in place, that was implemented in April. And then since the close of the quarter or the close of the half, we added another $5.7 million in cash that we got from the monetization of the Chinese milestone. This was done with our largest shareholder, AOP. This was done in Q3 2024. So to be clear, the $5.7 million is not included in the $8.1 million that we reported in cash. And last but not least, from a global perspective, as Anders mentioned, Kye Pharmaceuticals received Health Canada approval in August. We just reported on that recently. We are excited about that. Earlier this year, KP Pharma, our partner in Korea, filed a new drug application in Korea. Pending successful review, we expect an approval of that in 2025. And we are also anticipating the data from our pediatric study later in 2024. We are expecting that pretty soon actually. Digging a little deeper into the details of the financials. From a revenues perspective, we reported $12.1 million for the first half of this year. As I mentioned earlier, $11 million of the $12.1 million was from ACCRUFeR. And you can see on the slide, the 2 key drivers there, prescription and pricing. The remaining $1.1 million was revenues driven primarily from our global partners. These are for product sales in Europe, and these are royalties that we receive on those product sales. The $1.1 million compares to $600,000 that we saw in the first half of last year. So we are excited about the growth both in ACCRUFeR as well as ex U.S. revenues. Operating loss, we reported $15.5 million in operating loss. The components of those loss are, you can see, gross profit increased to $5.5 million compared to $1.7 million in the first half of last year. The growth in profit was driven primarily by the increase in ACCRUFeR revenues. Selling, general and administrative expenses was $18.8 million compared to $17.1 million in the first half of last year. The increase was primarily driven by the U.S. sales force expansion, obviously, supporting the launch and scale of ACCRUFeR. R&D was $800,000 for the first half of this year compared to $400,000 for the first half of last year. From a balance sheet and cash perspective, cash and cash equivalents, like I said, was $8.1 million. The year-end number comparatively was $13.9 million. So you can see we are looking to manage our burn on a quarterly basis over here. We have added a $10 million accounts receivable financing with Sallyport. That was basically a receivable of ACCRUFeR that can fund the $10 million line of credit that we have with them. This was put in place on 30th April 2024. In the first half, we also amended the $20 million debt facility that we have with SWK. This was amended to make the terms more favorable -- the covenant terms more favorable towards the company. And then, like I said, post period, we also added the $5.7 million monetization of the Chinese milestone with AOP Health, one of our largest shareholders. Here, double-clicking a little bit further into the prescriptions on a quarterly basis, you can see, we have a good Q2 2024 with 36,400 prescriptions. This is a 26% growth over Q1. So we like the fact that we have rebound there from Q1. Obviously, this is a testament to the Shield and Viatris field sales teams that have done a great job in terms of bringing this back on track. Our average quarterly growth right now, like I said, is about 25% following the field sales expansion with Viatris in Q2 2023. And the growth has come primarily driven in the large states such as California, Florida, New York and Texas. Obviously, this translates then into revenues and pricing. You can see on the left-hand side a 69% quarter-over-quarter growth in revenues. So Q2 2024 was $6.9 million in ACCRUFeR revenues, this excludes the global revenues from a global perspective. And then on the right-hand side, you can see the pricing. It continues to remain a bit volatile, but it's going in the right direction. You can see $171 net realized price per prescription, which is a 23% growth quarter-over-quarter. And then last but not least, we talked about the $8.1 million. I wanted to make sure that everyone had a view into the different components of how we are strengthening our balance sheet. We have a $20 million term loan with SWK, you can see the details on this slide. We added another $10 million of accounts receivable factoring, you can see the details on this slide. This was done, as I said, in April. Think of it as a line of credit that we can use the ACCRUFeR receivables to fund that line. And last but not least, the AOP Health deal that we just announced, which is the $5.7 million milestone monetization that we added after the close of the period. So with that, I'll hand it back to Anders.
Anders Lundstrom
executiveReady to take the questions.
Operator
operatorAnders, Santosh, thank you very much for your presentation this afternoon. [Operator Instructions] Just while the company take a few moments to review those 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&A can be accessed by your Investor Dashboard. Guys, as you can see, we have received a number of questions. And Alice, at this point, if I could hand over to you to chair the Q&A with the team, and I'll pick up from you at the end.
Unknown Attendee
attendeeGreat. Thanks very much. So we'll start working through the presubmitted questions first. So first question is, when do you aim to breakeven?
Santosh Shanbhag
executiveYes, maybe I can take that. What we have said in the past is we're looking at the growth of ACCRUFeR, and based on our internal assumptions and based on the internal forecast, we do expect to breakeven in the second half of 2025. And what I mean by that is we expect to be cash flow positive in the second half of 2025.
Unknown Attendee
attendeeThanks, Santosh. Second question, does management have any internal forecasts or expectations for 3- to 5-year forward revenues? What plans do you have for additional products and time frame?
Santosh Shanbhag
executiveAnd as I can maybe take the first half and then you can...
Anders Lundstrom
executiveYes, do the forecast. Yes.
Santosh Shanbhag
executiveWe obviously have our internal forecasts and expectations. We manage ourselves and the Board manages us through those forecasts and expectations. We have not made that public and we have not provided guidance in terms of near-term forecast. What we have said though is we do look at this as a peak revenue opportunity of $450 million, and we stand focused on trying to get there as quickly as we can.
Anders Lundstrom
executiveAnd on additional products, so I think it's worth reminding everybody, we're one year into the launch with -- here in the U.S. where we, together with Viatris have 100 people's sales force. So yes, we would, at the right time, add another product. I mean, it is also worth mentioning that we're only scraping the surface of the potential of this market where we are active in right now. The right product that would fit into our core targets, which would be primary care physicians or general practitioners or with OB/GYNs, yes, that will, of course, be something we would be interested in adding at the right time. But as Santosh said already a couple of times, what we're focusing on right now is the ACCRUFeR in the iron deficiency market.
Unknown Attendee
attendeeNext question is, why did none of the directors buy shares, especially when the share price is quite low?
Anders Lundstrom
executiveSo first of all, I mean, none of us can really comment on what each director, how they invest their money. So that's number one. Number two is that we've been in the closed period for quite some time. That period ends today. So that's where we are at.
Unknown Attendee
attendeeWhat progress is being made in the U.K.? Is ACCRUFeR available on the NHS?
Anders Lundstrom
executiveI mean, Norgine is our partner in Europe and also in U.K. We have had some struggles with reimbursement in the U.K. I know they are working hard to sort of improve the situation. The label we have in Europe is the same label we have in the U.S. So it's really up to them to make that comment, what efforts they are deploying in the U.K. to get to improve the situation. But we are in constant talks to them, and we will -- every year, we have an approved plan that they later execute on. So that's what I -- and Santosh, anything to add there?
Santosh Shanbhag
executiveNo, I think you covered it.
Unknown Attendee
attendeePlease, can you state the exact reason for Greg Madison's departure from the CEO? Was this influenced by institutional shareholders? And I'll also follow that up with a second part from another question, which is, where are you in the process of hiring a full-time CEO? Or what's the trajectory for that?
Anders Lundstrom
executiveSo when it comes to Greg Madison's departure, it was a mutual decision between himself and the Board. That's what -- that is what we stated and that's our comment on that. The search for new CEO. No, we have not initiated a new search as of yet. So I'll be here until we do that.
Unknown Attendee
attendeeGreat. You've previously mentioned challenges in Texas and the Q2 statement mentioned a rebound. Today, Texas is quoted as one of the large states behind the growth. Can you tell us a bit more about the profile of recovery in Texas and how trading is there now?
Santosh Shanbhag
executiveDo you want me to take that, Anders, and then...
Anders Lundstrom
executiveYes, let me start by saying, so what happened in Texas earlier -- and you can comment with me. What happened in Texas earlier this year is actually that the plan that paid for Medicaid prescriptions so that the provider, you could say, actually went away. So that's what happened, which is kind of -- it sounds like an odd thing, especially if we have a European perspective, then all of a sudden your product is not available any longer if you have a certain plan. So that is really what happened. It is odd. It's back again. It's back since April of this year, and that's why we see a rebound in -- why we can see a rebound in the second quarter. But that disrupted for us and for the patients the availability of ACCRUFeR to Medicaid patients.
Unknown Attendee
attendeeNow there's a little water under the bridge in regards to the third-party data provision. How has your conviction in the prescription data evolved? Are you back to full conviction in it?
Anders Lundstrom
executiveYes, yes, we are. Yes. It was another -- yes. No. That was last year where one of the providers sort of did not provide the data to IQVIA first, and then did provide the data to IQVIA, so was double reporting for a while. That's all over. I mean, that's happened in the third and fourth quarter of last year. So the data we have today is very solid, and there's no doubt that what you see is what it is.
Unknown Attendee
attendeeGreat. Is it possible to extend the patent and what would you need to do for this?
Anders Lundstrom
executiveWell, one thing that is happening actually is when we get the pediatric approval in Europe, for instance, and as Santosh mentioned, we hope to see that study concluded before the end of this year, is when we will get the 6-month patent extension in Europe. We're constantly sort of reviewing intellectual property because that's the most important thing you have protecting your product, of course. Now we have a very -- I mean, our IP doesn't expire till 2035, so -- but we would have, not every day, but the yearly review to see what could potentially be done to further strengthen our intellectual property.
Unknown Attendee
attendeeWhen talking about net selling price, does the average drift up gradually over time, or is it step-wise on the back of targeted discussions with formulary networks and payers, et cetera? And if the latter, how much scope is there to continue driving this with existing customers given the improvements already achieved?
Anders Lundstrom
executiveDo you want to take -- you want to start, Santosh, or...
Santosh Shanbhag
executiveSure. Yes, sure, I can start with that. Obviously, it's a concerted effort to make sure that we continue to increase our net selling price. It's not a very straightforward pricing model here in the United States. There are different payers and you have to negotiate with each one of them to ensure that the patients get access and then the insurance companies cover those patients. So we work with each one of them on a regular basis and try and maximize as much coverage as we can. So it's really a function of how much coverage we can achieve and how fast we can do that. Over the last 12 months since our partnership with Viatris really began, we have had good success and good progress on those -- on that front, which is why you have started to see that the pricing is steadily increasing. So I think we should expect to continue to see that. In areas where insurance does not cover or there are certain plans that do not cover the patient, Shield tries to help those patients by providing that medication at a subsidy or, in some cases, free. And as that coverage continues to improve, we can start to see that, by the work that is being done by both the Viatris team as well as Shield, you should expect to see that, that price goes up. So that is really the -- without getting into the excruciating detail, that's at a high level how I would describe the pricing. And so we should expect to see that price go up as time progresses. Anything to add there, Anders?
Anders Lundstrom
executiveNo, no. I think it was very well said. I mean, the system is complicated in the U.S., as you said, Santosh, and really people have different insurances and different level of coverage. But it is something we can actively work on our side as well. We can influence this. And that is what we have been doing, we are doing and we will continue to do, to the large extent ever possible. There will always be a portion that we would give away for free or give away heavily subsidized. It's just the nature of the market here. Unfortunately, everybody does not have good coverage. But typically, at the provider, at the physician's office, they see people from all walks of life. So that is what we do as a pharmaceutical company in the U.S. market.
Unknown Attendee
attendeePlease, could you explain the delay in the pediatric study?
Santosh Shanbhag
executiveYes. I mean, I would say, you should expect to see the data from the pediatric study soon. I think we'll just leave it at that.
Unknown Attendee
attendeeOkay. Who are your main rivals in the iron deficiency market?
Anders Lundstrom
executiveYes, it's a good question. Here in the U.S., it would be any oral iron you can go to the pharmacy and buy. So there's -- we are unique in the sense with the label we have and the approval we have. But as you probably are aware, there are oral iron salts that you can just go buy without a prescription in the market. So that is -- I mean, that is our biggest competitor at the moment.
Unknown Attendee
attendeeIs the strategy stretched too much and should focus remain on building the U.S. market share rather than trying to expand into other markets?
Anders Lundstrom
executiveSo we really only focus on the U.S. market from our -- with our own -- on our own, having our own people. Every other market, we either are in or plan to be in, we do with partners. And typically, when you have a partner doing it, then we can use Canada as a latest example or Kye Pharmaceuticals, they will do all the heavy lifting, they will do the investment in the local market. We provide guidance, we provide product, and we, of course, help them to get through the regulatory process and potentially a reimbursement process. But that is where it stops. So even if we were to expand into even more markets, or when Korea or China becomes approved, it typically doesn't require many more resources on our side. So our resources are focused on the U.S. market. Most everything of the resources, people, money, whatever, it is focused on the U.S. market. So we wouldn't -- we are not and we would not be that even if we continue to expand our geographical footprint.
Unknown Attendee
attendeeThank you, Anders. We have several questions along the lines of this, but will there be any need for further cash from shareholders prior to breaking even?
Santosh Shanbhag
executiveYes. I mean, I think -- maybe I can take that, Anders. As you've seen, we constantly are looking to strengthen our balance sheet. And you've seen we have continued to do that. We do that by managing our expenses, we do that by managing our working capital and accessing new capital. So having said that, do we need more money? If there is an opportunity to bring in additional capital into the company so that we can further invest in growing and scaling ACCRUFeR, I think that would be -- we would evaluate each of those opportunities on the benefit of the terms and make sure that we can bring in the right money at the right value. So that's probably what we would want to say on that. Anything to add there, Anders?
Anders Lundstrom
executiveNo. I would agree with you 200%. Yes.
Unknown Attendee
attendeeThank you, Santosh. Could you talk about churn and repeat orders?
Santosh Shanbhag
executiveSorry. Say that question again?
Unknown Attendee
attendeeCould you talk about repeat orders? Repeat prescriptions?
Anders Lundstrom
executiveYes. I mean, the way we do this, so if every salesperson has roughly 125 targets each, of those, what we do, we focus on like the top 25 or top 30 physicians they have in each territory. And those will typically be your largest prescribers. So yes, we see a good amount of people prescribing again and again and again and again, like you would like it to be. Very few are one-offs, right? So that is where we focus our effort. I don't have a number here to say, oh, our average physicians prescribe X amount of prescriptions per month, per year, or something like that. But our absolute focus is on those healthcare professionals that prescribe -- has the most amount of patients. And that is how we run our operations here.
Unknown Attendee
attendeeThank you, Anders. Revenues from Norgine seem to have grown solidly in H1. Are they doing anything different? And do you think this will continue?
Santosh Shanbhag
executiveNorgine has done a good job in the first half of this year compared to last year. There are several different contributors to that. But at the highest level, I would say, Germany seems to be doing well for them. They are expanding their focus areas into women's health in Germany as well. And I'm sure the reimbursement landscape there is slowly improving. So I think those would be the top drivers from our perspective. There are a lot more intricacies, probably not worth getting into the call right now.
Unknown Attendee
attendeeThanks, Santosh. Given the degree of discounting and discounts that insurance companies require, should we model a higher price of net, let's say, $200 or higher? I know today it's at $171.
Santosh Shanbhag
executiveYes. I think what we have guided previously, and we still believe in that is, we do think that this can get north of $200. I think we may have said $220 is the number that we look to target. We see -- we definitely see lots of levers in the model right now that we can use and go to get to that number. So $200, $220 is a reasonable assumption to have over the next 12, 18 months, I would say.
Unknown Attendee
attendeeGreat. And just following on from that, could you talk about insurance coverage? Which states do not have coverage at the moment and why?
Anders Lundstrom
executiveYes. Okay. So on the commercial side, we have about 60% of everybody covered, right? On the Medicare side, we have 0 basically coverage. And on the Medicaid side, we have very good coverage across all the states. So it depends on where the patient is really -- where they are insured, to sort of give you a full answer. It becomes a bit complicated actually. I don't have each channel -- the percentage of each channel and so forth. But what I can tell you is that a salesperson, they have that data available for them when they go see a provider or providers. They can see what the type -- what the mix of patients are, who's covered, who isn't covered and so forth. So that is part of how you operationalize your territories and so forth. And the challenge is, of course, we cannot -- yes, we're only going to go after patients who are covered because for one physician, they have a whole mixed bag of different patients with different type of insurances. So if you, for instance, have Medicare, where we charge a cash price or they can buy the product from us because they don't have coverage, you cannot say, yes and you're going to walk away. You still have to be able to provide them with some type of help to get on the product because, as I said, that prescriber have all types of commercial Medicaid/Medicare patients. So that's why we would need several slides to sort of answer that question in a very precise way.
Unknown Attendee
attendeeThanks, Anders. Santosh, probably one for you. The corporate presentation outlines minimum revenue targets for the term loan. Are the revenue targets cumulative?
Santosh Shanbhag
executiveYes. So the revenue targets are a rolling 12-month revenue target. So every month that goes by, you look at the last 12 months, and that's the rolling target that you're looking at. So it's cumulative from that perspective, yes.
Unknown Attendee
attendeeAnd then I think this is probably the last one, unless we have some more come through. I think I saw in the performance slide increased sales and margins in the same period, and significantly increased operational loss. If that was correct, please could you explain?
Santosh Shanbhag
executiveYes. So you can see that our gross margins increased on ACCRUFeR, and that's primarily driven by the fact that ACCRUFeR is growing. So gross margins on the product continues to increase because of the revenue growth. We did see an increase in operating expenses period-over-period, so first half '24 versus first half '23. And that was driven primarily by the fact that we have a full sales force right now. So keep in mind, we launched our sales force in Q2 of last year. So the 100 people that are in our sales force came really in the second part of last year -- in the first half of last year, versus in the first half of this year, we had the full sales force for the entire 6 months. So there's a driver there as well. There are additional sundry items that get added into the G&A. So the expenses related to the financing also get added within the general and administrative expenses. You should also expect to see that as we wrap down our pediatric trial, those costs will start to go down as we see into the second half.
Unknown Attendee
attendeeFantastic. And just following on from that, what would need to happen to the size of the U.S. sales force in order to address the expanded market size as opposed to just the current market size?
Anders Lundstrom
executiveWe wouldn't need a larger sales force to do that. And that would probably -- the way we do that, it will happen in increments. You wouldn't jump from covering 12,500 HCPs to 50,000, as that is like, it's a 4x jump, which would technically mean you would have like a 400-person sales force. We will do that in increments. But that is sort of the plan of how we would grow ACCRUFeR in the U.S.
Santosh Shanbhag
executiveYes. Maybe I can add there too, Anders. I think if you take a step back, you can think about the go-to-market in really 2 large buckets. There's the feet on the ground, which is the sales force, which is a fixed cost that companies can incur, or it could be marketing spend that you opportunistically take advantage of certain times of the year and spend a little bit more in marketing, which is a little bit more variable and we can control that cost on an ongoing basis. So to address that expanded market, we don't have to put all of our chips in one basket, which will be the sales force expansion. We could leverage some of those investments in marketing. And so it's kind of a mixed resource allocation or capital allocation. But to Anders' point, if we really want to go after the full 6 million prescriptions of 50,000 physicians, you would have to expand the sales force. But that would be massive and we wouldn't want to do that. It would be a well-thought-through expansion into that space.
Unknown Attendee
attendeePerfect. And then I just actually had another follow-up to that question. Can you give us an idea of how an individual salesperson drives sales over time? I assume this is settling in period, but are sales continuing to grow with the most long-standing sales people?
Anders Lundstrom
executiveIt does. And it's a matter of how -- breadth and depth, right? So how many do you call in? And then, as I explained before, you typically have your -- whatever number of top prescribers you have in your territory, you work on those who have the largest accounts. So that's what you do. And you can see that, which we look at, for instance. So what does it look like from time point 0 and you move ahead -- into 12 months ahead? What does that look like in that territory? What targets would they need to reach, and so forth? And it is something we measure very, very closely because we would expect to see growth. And then -- and we would expect now to continue to see that growing as well since we have only penetrated 3% into our current market. But that is how we go about that. And it's measured very, very closely because we have very good data that we can follow the penetration into a territory [indiscernible] breadth and depth in calling on your targets.
Unknown Attendee
attendeeAnd then just one last question. How do you intend to improve shareholder value?
Anders Lundstrom
executiveYes. I mean, that is what I think. What we've seen now over the last -- I think -- again, I think the perspective, sometimes we forget it ourselves. But we've only really been active for 4 quarters with a full strength here in the U.S., which is really the biggest driver of our revenues. Of course, other markets will help out as well, but the U.S. is the key market. And by continuing to execute according to the plan we have in place, that is going to be the biggest driver for shareholder value going forward. Anything else, Santosh, you want to add to that?
Santosh Shanbhag
executiveNo, I think you said it perfectly. I think we are -- as a company, we are hyper-focused on operational execution and growing ACCRUFeR, and growth in ACCRUFeR and the -- whether it's revenues, prescription or pricing. That's what we are focused on. And we are seeing that happen. Over the last 12 months, we have seen that happen. We expect that to happen going forward. And that should hopefully translate into shareholder value as we see in the future.
Unknown Attendee
attendeeThank you, Anders. Thank you, Santosh. Lily, I'll hand back to you now.
Operator
operatorAnders, Santosh, thank you for answering all those questions as you can from investors. And of course, the company can review all questions submitted today, and we'll publish those responses on the Investor Meet company platform. Just before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Anders, could I please just ask you for a few closing comments?
Anders Lundstrom
executiveYes. First of all, thank you for listening and thank you for all your very mindful questions. We've had a great first half of this year. We're very excited to see the strong quarterly-over-quarter growth over the last 4 quarters. And this growth is seen since we launched our co-commercialization effort with Viatris. To Santosh's point, that is what we focused on, continue to be very efficient with our commercial operations here in the U.S.
Operator
operatorAnders, Santosh, thanks for updating investors today. Can I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback in order that the management team to better understand your views and expectations. This will only take a few moments to complete and 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, and good afternoon to you all.
Santosh Shanbhag
executiveThank you all.
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