Good afternoon and welcome to the Shield Therapeutics webinar, where the team will be providing an update on Shield assuming full control of ACCRUFER in the U.S. Throughout the presentation, attendees will be on listening mode. However, questions are encouraged throughout today's webinar. These can be submitted via the chat function in the bottom right corner of the screen. Simply type in your question and click send. The company might not be in a position to answer every question submitted today, and where appropriate, share a response following today's presentation. The webinar today is being recorded, and we will be publishing this on the Shield Therapeutics website after today. I'd like to hand over now to Shield Therapeutics CEO, Anders, CCO, Andy, and Bryon, Senior Director of FP&A. Thank you, Polly, and good afternoon, good morning, everyone, and thank you for joining us. I am Anders Lundstrom, and as Polly said, I'm also joined by Andy Hurley, our Chief Commercial Officer, and Bryon Kallert, our Senior Director of Financial Planning and Analytics. As many of you will have seen, we announced last Thursday, we have reached an agreement with Viatris, our current U.S. partner, to assume full control of ACCRUFER in the U.S. This is a landmark opportunity for our company, and we're glad we have this opportunity to walk you through it more in detail. The purpose of today's call is to explain as clearly and fully as we can why we believe this is such a significant milestone for Shield Therapeutics. Next slide, please. Before we begin, please note that the disclaimer on the slide regarding the forward-looking statements. We'll start with a short presentation, after which we'll open the floor for questions. We have received a number of pre-submitted questions, which we will start with, and that we'll, as Polly said, try to cover as many questions as we ever can. Can I have the next slide, please? As the title says, we are assuming full U.S. commercial control of ACCRUFER. We entered into an agreement with Viatris, our partner in the U.S. since about four years, that says that we will assume full commercial responsibility, and the anticipated closing date is September 30, 2026. We'll start the fourth quarter promoting ACCRUFER on our own. This transaction represents an important strategic milestone for us, giving us full control of our largest market and also enhancing our economics of ACCRUFER. In addition to that, it creates a very strong platform for future growth. Just as an example, we estimate gross profit to expand around 75%-80% and an EBIT uplift about almost 2x over the five-year term we have with Viatris. We will assume responsibility for a dedicated U.S. sales force. We will bring over those people who have been with Viatris, so it's about 40 people in that organization. That is why this will take us a little bit longer before we can start because we're working out all the details to bring them over to us. After that, we will be fully responsible for the commercialization here in the U.S. for ACCRUFER. The next slide, please. A few more details here we would like to share. This transaction immediately improves our economics through increased net sales retention, improved margins, and a stronger cash generation. Also, this gives us more flexibility, when we are in charge of the product alone. It will enable us to have more flexible and fast decision-making. This will also sort of strengthen, I think, our leadership position. We have reached this point together with Viatris that we have grown, as we have seen over the last four years, a lot. This provides a strong foundation for continued growth and market expansion. For us, or rather for the people who prescribe our products and the patients who receive our product, this will be a seamless transition. As we explained to you before, we have 80 sales territories that are unique. We have had 40 each on each side. We had 40, Viatris had 40. That is the structure that will continue to be in place. Thereby, it will be for anybody who is our customer will be a seamless transition. The deal reads that we will pay Viatris a royalty on the U.S. net sales. As we have announced, it is ranging from high single digits to the mid-teens over a five-year term. What it does for us as a company and why we are also so excited, this additional commercial capacity we have now, it also gives us, as a company, a stronger platform for additional opportunities to sell and market in the U.S., and also will accelerate our long-term value creation by this deal alone, and also, of course, with the expanded platform, we have to potentially bring in other products as well. The next slide, please. This slide, Andy will cover more than closely to what happens in the U.S. market. Andy, please. Thanks, Anders. To expand on Anders mentioning that seamless transition, in terms of continuity of business, many aspects of the commercial model is going to remain the same. Since launch, Shield has had sole ownership of the launch strategy, all of marketing, commercial operations, trade and distribution, data management, manufacturing, regulatory, medical affairs, sales training, and pricing strategy. What changes is that we now fully own the sales infrastructure with the addition of the Viatris sales leaders and sales reps that are coming over with the transition. We are going to assume full responsibility now for the market access strategy and the payer engagement activities that go with that, and we are in the process right now of hiring a team to take on that responsibility. This move, as Anders mentioned as well, we are excited about it, and we really appreciated the partnership we had with Viatris, but it is going to allow our commercial team, as we move forward, to have even greater flexibility in driving sales execution. That is just a summary of the transition from the commercial side. I will turn it back over to you, Anders. Thank you. May I have the next slide, please? I use my own quote as a summary of today's presentation, and I would like actually to start with a thank Viatris for their partnership over almost four years. It has been a very strong partnership. We have together built a very strong market position for ACCRUFER. As I said, thanks to the structure of this deal that we are taking on the sales force that already have vast experience with ACCRUFER, we look forward on building on the success we already created together as we move on into the next phase for the growth of ACCRUFER and the growth of Shield. As we also are highlighting, it is an important strategic milestone for us as a company because it reflects the significant progress we have done so far in establishing ACCRUFER as the leading branded prescription oral iron in the U.S. But as we then assume full control here in the U.S., we also enhance the economics of Shield, we strengthen our ability to execute our growth strategy, and creating a scalable commercial platform for the future. What does it mean? It means that if we so have the opportunity, which we actively are looking for, to add another product, we are now in full control of the entire commercial organization, which actually makes it easier for us as a company to add on another product. We touched this on a couple of slides already, and that we are acquiring a proven commercial infrastructure, and that is very important. That is going to be seamless. We believe the customer-facing aspect is going to be very seamless. It is going to take us another month to work out all the details to bring everybody over, but the teams are working really hard on both sides, both on the Shield side and the Viatris side, to make this happen during this month. It will increase our cost base, but these costs are expected to be more than offset by the increased margin we will be able to receive. We believe as we are already a fully integrated company, we have all the functions we need to do this. This is not a merger of equals. The people we have already will, of course, stay with us, and we will be able to mainly grow our sales force, and that is the only thing that comes over. We will add, as Andy said, the market access function as well. We are certain we will be able to continue to improve access to ACCRUFER for patients and healthcare professionals as we move forward. That concludes the formal part of the presentation, and we just move on to questions, and we will answer them as we can. We will start, as I said, with 14, 15, or 16 pre-submitted questions. I will start by reading those questions, and we answer them, and then we will take additional questions that I hope has come in during this presentation. I am actually not able to see them, those questions. The first question is about something else, really. The question is: Will the business be likely to have more signed GPO contracts by the end of this year? Andy, where are we? Would we have more GPO contracts? Yeah. I will speak to that. We continue to look at different channel opportunities to grow ACCRUFER in the facilities that use GPOs, and we are going to continue to evaluate other GPOs that warrant us contracting with them for ACCRUFER inclusion. We just signed with one of the bigger GPOs, as mentioned on previous calls. We are still putting efforts towards that new channel opportunity, and early signs are saying that that is going well. If that continues the way we expect it will, then we will continue to look at that as a possible channel opportunity that expands beyond the one that we have right now. Good. Thank you. Second question. While this seems like excellent news, does taking full control mean more funds will need to be raised, or do the existing options cover this? Also, does this move enable the current debt facilities to be expanded on better terms? Bryon, you will start answering that question, please. Yeah. Thanks, Anders. I can start with that. Yeah. Just as a reminder that this transaction does not actually require any upfront payment to Viatris as part of the close, and we do expect it to be accretive immediately, as previously mentioned, improving our margin and cash generation and really supporting our path to operating profitability. The deal itself does not create any additional financing needs. Okay. I would like to add, we told you many times that ACCRUFER is a really promotionally sensitive brand. We said also before, if we were able to invest more money, especially in marketing, we know that drives more prescriptions, and in other parts of the business as well. Since we now are in full control of the asset, if we see that more investments would drive more revenues, that is potentially something we could raise money towards. But we will, of course, let you know in due time. But as Bryon said, the transaction in itself, there is no need to raise additional capital. Third question following on here, how much additional annual operating costs will the deal add? Bryon? I can take that one. Yeah, I can take that one as well, Anders. We expect, by bringing on the new sales force, that our operating expenses should increase about 30% year- over- year. Okay. Thank you. Next one is, when Viatris and Shield both maintain separate sales team, they would have had duplicate additional overhead, so management, HR, and so forth. What synergies are we anticipating with a single structure? This is not a merger of equals. I would say simply, but it is simply we are absorbing the sales force from Viatris. So for us, as I mentioned before, we have had all the functions in place. We continue to have all the functions in place as any integrated company would have. So it does not change much from that respect at all. So there is no additional savings for any duplicate overhead or anything like that. Andy, would you like to comment on that one as well, so people get a better understanding on what we had before and what we will continue to have? Yeah. So we had a mirrored situation with respect to how we went about building the sales infrastructure. So every single sales rep has a dedicated, solely owned geography, so we do not have overlap there. As Anders mentioned, as we are inheriting the sales force and bringing them over, there is not duplication in those sales geographies. Those are independent. They are all sales territories that have had staffing in the past, and we will bring them over exactly that way. So we are not going to be finding duplication in the way that that crosses over. Thank you. Would you expect your gross margin to be on U.S. ACCRUFER sales after the deal completes? Bryon? So as previously stated in the presentation, we estimate that the margin would go between 75%-80% post deal close. Thank you. There is a number of questions regarding takeover discussions about the Cavendish forecast has a certain number, why we do not do a similar deal with Norgine. I want to answer that, and why people do not buy shares instead of the company. We cannot comment on what other people are doing, or other companies have been thinking, or if there is anything like that going on. We will address the questions that is about us solely. We will actually skip all of those except the Norgine question. Would you consider doing a similar with Norgine? We cannot. It is very different, actually. First of all, we do not have a commercial infrastructure anywhere else but in the U.S. Secondly, as we do with most of our out licensing is that Norgine, they own the registration in Europe, so it is their product, quote unquote. It is our product from an IP and production point of view, but we cannot do a similar deal like that. That is the big difference, and that is why that is not happening at all. We will have one here. To reach your goal of operating profitability in 2026 would require another GBP 35 million in ACCRUFER sales. This requires higher prescription growth in the second half of the year compared to what we ever had before. How will you achieve this? We have never given out a forecast what actually it is we would need here or there. As we said, this deal by itself is immediately accretive. Typically, our H2 is much stronger than our H1, as we actually shared with you in the previous presentation we had as well. This deal is accretive in itself. We cannot really comment on how much more revenues we would need to reach any profitability at this stage. We are still, of course, aiming at being profitable by the end of the year, as we stated before, and of course, this deal helps us a lot coming closer to that point. There is a question on, does this deal increase Shield's financial sensitivity to the sales performance? Bryon, what happens there? Yeah. From the deal economics perspective, lower royalty rates at the same time, we are picking up increased costs. But at a lower royalty rate and our cost pick up, it is more beneficial from Shield overall from a cash generation, sales retention, and profitability standpoint. Yeah. And the last of the pre-submitted questions. From the management perspective, has Shield demonstrated this operational success with ACCRUFER to justify adding a new product to that portfolio? Andy. Yeah. Through the success that we have had with ACCRUFER year-over-year, I think we have definitely demonstrated that we have the skills and the capabilities to have success in putting a new product in the bag. As I mentioned, we built a commercial infrastructure that would be able to be scaled quickly to support another product. The answer is yes. Yeah. Good. What other questions do we have, Polly? Sorry, just jumping back in here. We have had a few of the same questions coming through, so I think you have covered quite a lot of them so far. One question was, this looks like a great deal for Shield. Why did Viatris, or what drivers drove them to agree these terms? Again, this is one of the questions I cannot speculate on Viatris' side why these terms and why they agreed to them and so forth. The only thing we can say that for us, this is a very good deal, and as we said, and as Bryon just commented, even with the increased cost, thanks to that, we actually get our sales force over, with the lower royalty we would be paying, it is immediately accretive for us. I cannot speculate on the Viatris side. No worries. I think that is most of the questions now. As I said, most of them have already been answered throughout this. One question that has come through, when do you anticipate ACCRUFER Syrup to come to market? We are currently doing the stability testing, so that's the next step. The second thing we're doing there is to look at the market opportunity here in the U.S. for those under 10 years old age, because that's where the suspension will be used. So that's the second thing we're doing right now for that younger age group. When it comes to treating iron deficiency, it is actually quite a lot of different options already available, which is different from if you look at the slightly older children from those of 10 and above here, and I believe 12 and above in Europe, where they can take the oral tablet. So those are the two things. We're waiting for stability and doing a market assessment here in the U.S. Would you need a separate sales force for that in U.S.? No, we would not. We already are detailing or calling on pediatricians with the tablet for the older children. No, we would not need additional sales people to promote a suspension. It looks like a great change. H1 was EBIT profitable. To be clear, the target is that the total picture for full year 2026 will be EBIT profitable. Bryon, you want to start answering that? Yeah. I think it is just reiterating what we already discussed. Yes, H1 was EBIT profitable, and we are still striving for EBIT profitability for the full year 2026, and this deal does help us drive to that as well. Yeah. Perfect. Well, I think that is everything for today. Unless there is any other kind of thoughts on your side that you want to cover off before we finish for today. I would just like to say so far thank you for attending. Thanks for the questions. If there are other questions, we will do as we usually do, you submit them to us and we will answer them in writing. The last piece I will share is that we are very happy to announce that actually our new CFO, Michael Jensen, starts today, September 1st. So we really look forward to bringing him very closely on board with us at Shield Therapeutics, and the next time we do this, you most likely meet him. So thank you so much. Perfect. Thank you for the Shield team for updating investors today. On behalf of the management at Shield Therapeutics, thank you for joining. The recording will be available via the Shield Therapeutics website, and if you have any further questions or if we didn't get to any of those questions, we'll be able to answer those there. Thank you all again, and have a great afternoon.
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