Good afternoon and welcome to the Shield Therapeutics Plc Investor presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time via the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself; however, the company can review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll, and I'll now allow it to hand over to the management team from Shield Therapeutics Plc. Anders, good afternoon, sir. Good afternoon and thank you so much, and welcome everybody. Thank you for joining us for today's presentation about Shield Therapeutics. Santosh, who is our CFO, and I, Anders, will present. The first part is a general part about the company, and for those of you who have followed us before, this may be a repetition. And then Santosh will follow me with a recent Q3 trading update after a little while. So we can go to the next slide. This is the disclaimer, and I'll move into the actual presentation. So we at Shield Therapeutics, we have one commercial product. It's called ACCRUFeR in North America and Feraccru in the rest of the world. And it is the only FDA, EMA, U.K., and Health Canada approved oral iron that's broadly indicated for adults suffering from iron deficiency or iron deficiency with anemia. This market is a large market because traditional oral irons are typically discontinued because of GI side effects such as stomach pain or constipation, leading to that patients stop therapy. I'll come back to that a little bit more in detail in a little bit. We have a very experienced executive team with extensive U.S. commercialization expertise, and in the U.S., we do co-commercialization with our partner, Viatris. In the rest of the world, there are our partners who are doing the commercialization alone. We estimate our peak revenue potential for ACCRUFeR to be around $450 million, and we have very strong IP through 2035. This is the management team. To the right, you see David Childs and Jackie Mitchell. They are in our Newcastle office responsible for development, quality, regulatory affairs, and manufacturing. And the four to the left are the people we have in our Boston office who are focusing more on the commercialization in the U.S. So what's the problem here? What is it that we're trying to solve? So in general, healthcare professionals are struggling to treat iron deficiency because most patients cannot tolerate the normal oral preparations. And that is because the oral ferrous salts, they dissociate in the stomach, and unabsorbed iron leads to causing irritation and damage to the intestinal lining. And thereby, you see these gastrointestinal side effects, as I mentioned, like stomach pain. It could be bloating. It could be constipation. And thereby, a large portion of the patients stop therapy, which of course leads to lack of effectiveness. With ACCRUFeR or Feraccru, we have a very elegant solution to avoid that. Our product is not dissociated in the stomach, but rather in the upper intestine. Thereby, we avoid many of the side effects, and people tolerate this treatment much better, so they can stay on it. Thereby, we see very good results with our treatment. These are our global partnerships we have. As I said, in the U.S., we have a very strong partner in Viatris, and here we co-commercialize. We have together a 100% sales team in place in the market. We have about $30 million in available sales milestones with Viatris. In the rest of the world, we completely rely on our partners. Norgine is our partner for Europe and a few more countries. There we get straight royalties, and we have milestone payments coming up. We just announced we finished the pediatric studies in the E.U. So we foresee getting milestones for that. In Canada, which was the latest market to get approved in August of this year, we work with KYE Pharmaceuticals. We anticipate a launch early next year. Here we have revenue-based milestones and double-digit royalties on net sales. In Korea, we are under review as we speak right now. We work with Korea Pharma. We anticipate to get an approval in 2025 and a launch following that. Here we have mid-teens royalties on net sales. In China, we work with ASK, and we are doing a bridging phase three study in the Chinese population to sort of link that back to the Caucasian population where we've done our previous studies. We hope to finish the study this year, submit the file next year, and looking at an approval in the second half of 2026. Again, we have approval milestones. We have double-digit royalties on net sales from China, and we continue to evaluate other geographies in the world as well constantly to see if we can find other partners who can sell our product in those regions, so this is the U.S. market, so what you see, the total market, which we call the addressable market, is about 12 million prescriptions annually prescribed by about 500,000 healthcare professionals. We are in the current market, so that's the market we are focusing on right now. That's where we have our 100 salespeople. As you can see, it's about 1.8 million prescriptions annually prescribed by about 12,500 healthcare professionals, and we have today a small market, which is 3%, and we, of course, as Santosh will show you very soon, we keep growing in this marketplace, but there's so much more growth to be had. We are constantly driving awareness in this marketplace. The expanded market is sort of half of the total market where we have about 50,000 healthcare professionals doing that. That would, for us, be our expansion step, but that is something we would look to do maybe in two to three years. So in summary, there is, as I explained, a large unmet need due to that traditional irons typically lead to gastrointestinal side effects, leading to the patients stopping taking the therapy. It's a rather concentrated prescriber base in the U.S., and we have 100-person sales force that can cover that market that we are addressing at the moment. Then, as I explained, so ACCRUFeR Feraccru is uniquely positioned to address the unmet need thanks to that we are not dissociated in the stomach, but rather so we can avoid the gastrointestinal side effects to a much larger extent, leading to a very good treatment result. It's a promotionally sensitive market as well. We know that. We know that both patients and healthcare professionals are highly engaged. They are looking for solutions, and we see a very good response on the marketing campaigns we do. And finally, we have very minimal branded competition. So that's the general part of the presentation, and now I will leave it to Santosh, who will go through our recent quarter three results. Santosh. Thank you, Anders. And hello, everyone. Let me walk you through our Q3 2024 business highlights. As you can see on this slide, slide number 10, our 2024 business priorities are threefold: growth in ACCRUFeR in the U.S., which includes revenue, price, and prescription; strengthening our balance sheet to support both our near-term as well as our long-term growth ambitions; and number three, access to our innovative products globally. As you may have read in our press release on Tuesday this week, we have made significant progress on all three fronts in Q3 2024. During the third quarter of 2024, we reported net revenues of $7.2 million from approximately 43,500 prescriptions of ACCRUFeR, with an average net selling price, or what we call NSP, of $167 per prescription. I will speak more to this in the next slide. From a balance sheet perspective, we ended this quarter with $7.7 million cash on hand compared to $8.1 million in Q2 2024. Post the end of the quarter, we also added and took multiple steps to strengthen our balance sheet and extend our cash runway. This includes a 10% reduction to our cost base, expanding our accounts receivable financing from $10 million - $15 million, and entering into a non-binding term sheet with AOP Health, our largest shareholder, for a minimum of $10 million of new equity-based financing. I'll speak to this in the next couple of slides as well, and lastly, in Q3, we also reported that our pivotal trial in the pediatric population with ACCRUFeR showed highly clinically relevant effectiveness with no patient discontinuations due to adverse events. We plan to file these results with the FDA and EMA in the first half of next year. Note that we expect to receive development milestones totaling EUR 1 million from Norgine as we go through the regulatory process. As you will see on slide 11, let me move to the next slide. As you will see on slide 11, we reported approximately 43,500 prescriptions of ACCRUFeR dispensed in Q3 2024. This represents another quarter of growth with nearly a 20% increase in prescriptions compared to the second quarter of this year. Keep in mind that we recognize revenue when the units are sold to wholesalers and pharmacies and not when the prescriptions are dispensed to patients. We reported $7.2 million in ACCRUFeR revenues in Q3 2024. That represents a 4% growth compared to the second quarter of this year. The difference in the growth rate between revenues and prescriptions was due to the wholesalers buying ahead of the July 4th weekend during the last week of June. If we adjust for this buying pattern, the sequential growth rate in revenue would be identical to the prescription growth rate of 20%. Similarly, on pricing, adjusting for July, the net selling price was $192 per prescription compared to $171 in Q2. Our expectations are that the net selling price can be maintained at similar levels or even higher throughout Q4 2024. Once again, the fundamentals of the business with ACCRUFeR in the United States are very strong, and it is a testament to the collaborative work by both Shield and our U.S. commercial partner, Viatris. On the next slide, slide number 12, we have outlined the details of the key elements of our balance sheet. We continue to maintain the strong relationship with SWK and the $20 million debt facility we have in place with them. Earlier this week, we also reported total group revenues of $20 million year to date through Q3 2024. This includes royalties and milestones from our global partners. Based on our internal estimates, we expect to meet the total revenue covenant target of $31.5 million for full year 2024 under the debt facility agreement with SWK. Now, post-quarter, upon evaluating our internal projections and our current burn rate, the board has concluded that we will need to, A, lower our operating base and, B, access additional capital to help achieve our goal of becoming cash flow positive by the end of 2025. We have hence prioritized three key initiatives. Number one, we are implementing a cost reduction of approximately 10% to our operating cost base across the company. Number two, we are implementing an expansion of our current working capital financing with Sallyport from $10 million- $15 million. Now, keep in mind, this is not new money. It is our own money that we collect faster. Both these initiatives will help us extend our cash runway into the second quarter of next year, and number three, we have also entered into a non-binding term sheet with AOP Health, our largest shareholder, for a minimum of $10 million of new equity-based financing. The details of this term sheet are outlined on the right-hand side of this slide. Now, keep in mind that the closing of this financing is conditional upon approval by the Takeover Panel and the shareholder board. We are working diligently to close this process successfully and as quickly as possible. We believe that these initiatives can help us achieve our aim of becoming cash flow positive by the end of 2025. This should allow us to have enough capital to help us get there. Now, obviously, our rate of cash burn remains highly dependent on ACCRUFeR achieving our internal forecast, and we are looking forward to it. With that, I will hand it back to Anders to conclude. Thank you, Santosh. As you have heard, there's a very big market opportunity in the U.S. alone with a very significant revenue potential. As I described so far, we have a rather low market share in the addressable market, but as Santosh has outlined, we see very nice growth quarter over quarter. We, of course, are looking to the other parts of the world as well, and we keep expanding. I mean, ACCRUFeR or Feraccru is approved by the FDA, EMA, Health Canada, and in the U.K., and we're looking forward to new approvals after reviews in markets like Korea and China as the years go by. We have a very strong partnership in the U.S. We have a very strong partner with Viatris that helps us reach our goals, and we see a good growth in prescriptions, net revenue, and net selling price in the U.S. market. As Santosh also explained, we have increased our balance sheet and our operational flexibility, and we believe now that we have enough resources to get to cash flow positivity by end of 2025. So that concludes the presentation part of this meeting, and we'll now move on to questions. Santosh, thank you very much for your presentation. If I may just bring back up your cameras. Ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab situated on the top right-hand corner of your screen. Just while the company takes 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 via our investor dashboard. Alice, could I please ask you to read out the questions and give responses where appropriate to do so, and I'll pick up from you at the end? Fantastic. Thanks, Lily. So the first question is, the most important issue for Shield is sales volume and revenue growth. Will Shield present quarter-by-quarter sales volume and revenue growth projections as anticipated by the Shield executives? Santosh, you go ahead. Yeah, sure. We have set a standard where we report out our quarterly numbers as soon as we wrap up the quarter, and we continue to plan to do that. So we will keep the shareholders and investors up to date on our performance every quarter. At this point, we do not plan to provide projections. It is a bit too early for us to provide any quarterly projections into next year. What we have said, though, is based on our internal projections, both ACCRUFeR's projections, our ex-U.S. revenues potentials, and managing our operating expenses, we expect to be cash flow positive by the end of next year. Thank you, Santosh. Next question. Have you had any discussions with the E.U. partner regarding reimbursement resubmission for France, Italy, and Spain, and are you also able to provide any further information on Korea? So let me take that question. So the short answer is yes. There's been quite a lot of work going into trying to get to those three markets in Europe, France, Italy, and Spain. In the end, the decision lies with Norgine. So you would actually have to ask them what their decision will be. But I repeat it again, yeah, there's been a lot of work looking into those three markets because they are three really significant markets in the U.S. For Korea, we know that they are actively reviewing our file as we speak. We have gotten questions from the authorities, and we are answering those questions. So we are looking, if everything goes well, which we anticipate it will do, we will be looking at an approval sometime during next year. Thank you, Anders. How much of your business is repeat prescription? If people need the products, are they on it for life? Do you want me to take that, Anders? Yeah, yeah, let me take the second. No, I mean, of course, it depends on the condition if the patient is a chronic patient or not, right? So if a patient has, for instance, chronic kidney disease, yes, they could be on for life. If the patient has, for instance, IBD, yes, they could be on for life. But most of our patients are taking the treatment for three to four months. So it's not a chronic; you should not view this as a chronic treatment because the focus we have in the marketplace is typically also in the OBGYN space, women's health, and they are not chronic patients. The focus we have with the primary care physicians is different because they do see what I mentioned, all of those types of patients. But I paused there and I let Santosh get us a little bit more into the numbers. Sure, Anders. Absolutely right. When you think about the prescriptions and the refills, from a patient perspective, it really depends on the type of patient. But on average, we have seen somewhere in the three to four refills per patient, and that differs based on whether it is a patient who is covered by commercial insurance, whether it's a patient covered by Medicaid insurance, or if it's a patient that is paying cash out of pocket. So it varies, but we have typically seen somewhere in the three to four. I would also add that in terms of Q3, when you think about the contributions of refills to the prescriptions versus new prescriptions to the total prescriptions, it's about half and half. It's skewing a little bit favoring the new prescriptions when it comes to contributions to total prescriptions. And then in terms of contributions of existing prescribers versus new prescribers, the split varies quarter to quarter, but Q3, it was about 70%-30%. So 70% of our prescribers were existing prescribers from prior quarters and 30% were new prescribers. So across the board, I think there's strong support from both physicians as well as patients. Those who continue to write, continue to write in the future as well. The word of mouth is spreading and new physicians are coming into the foray as well as patients continue to believe in the product and continue to take the product for the duration of the course. So excited about what we're seeing. Thank you, Santosh. How many tablets days do you get for the $192 average price? Is it one tablet for 90 days? Also, this seems quite a high price. Is this covered by people's insurance companies in the U.S.? Our ACCRUFeR in the U.S., Feraccru in the rest of the world, it's two doses per day, so two tablets per day. That is what it is. And the $192 is the price per prescription, which is the month. So that is the pricing in the U.S. Yes, typically prices in the U.S. are higher than in the rest of the world. And yes, in general, we have good commercial coverage for patients who are getting their health insurance from their employers. We have very good coverage with Medicaid, and we do not have very good coverage with Medicare. So it depends on what type of plan the patients have if the $192 are covered or not. That's a factor we actually also weigh in coverage when we focus our salespeople. So because if a physician has no coverage, we have a solution for that. Sometimes we give away drugs for free. Sometimes there's an out-of-pocket that varies depending on what type of insurance they have. So this is an average price we see, but that is everything from $0 up to $200 and something per prescription. So this is just an average price. Fantastic. Thank you, Anders. I think your microphone just might be knocking on the table. You provided a bit of feedback. That's okay. Thank you. The next question. Shield has entered into agreement to raise 10 million equity with AOP Health. Could you provide a little more explanation on the reasoning behind this? You've got a long-term loan of $20 million, so I'm unsure of the reasons for the equity raise, especially when you're on track to meet orders. You want me to take that, Anders? Yes, please do. Yeah. I think, as I said in my prepared remarks, the board and management, we looked at our internal projections. We looked at our growth projections. We do expect ACCRUFeR to continue to grow, and we have seen that over the last few quarters, and we expect the same over the next year. However, when you look at our balance sheet strength and what we need to help us to get to cash flow positive, we have had to make multiple decisions. And one of them was making sure that we reduce our cost base, and we've taken steps to doing that, so 10%. That's in our control. Number two, we have expanded our financing with Sallyport from $10 million - $15 million. That's not new money. That's our own money that we collect faster. But just those two elements really help us extend our cash runway into Q2 2025. We need more to help us get to cash flow break even, which we expect to be in the second half of 2025, and so when we looked at the different options, we evaluated all the different options, and we ended up with the AOP Health's $10 million, a minimum of $10 million via equity financing. And it is a non-binding term sheet that is contingent on a few things that need to take place between now and hopefully by the end of the year, but we believe that the $10 million helps us get there, helps us get to the being cash flow break even by the end of next year, and so I would say those are the three pieces that we have put in place to help us get to that goal of cash flow positive by the end of next year. Thank you. Let's have a look. The Q3 trading update described increased buying from wholesalers around the 4th of July weekend. How might these volumes have affected the average net selling price for Q3, and we might expect some destocking in these channels in Q4, but see an associated rise in the average net selling price. Okay. No, no, good question. I mean, I think Santosh tried to explain that in the prepared remarks. Basically, the math is like this. July 4th this year was on a Thursday in the United States, and a lot of people take that week off. So our wholesaler, Cardinal, decided to buy that week of goods a week earlier, so it ended up in June. So now we have an extra week of sales in June and one week less of sales in July. If you take the average sales over 13 weeks in the third quarter and you take one week out of the second quarter, add it to the third quarter instead, you get a 20% revenue growth. That is how we get to the 20% instead of the 4%. So that matches the prescription growth. Likewise, when we do the average price per prescription, as I tried to explain earlier, some of those prescriptions we get $0 for, or even we lose money on them depending on how, and some of them we get way more than $192 for. If you take out one week of paid product from the third quarter, in July, the average price goes down rather dramatically. So that's why in that month, it was just over $100 per prescription because we lost a week of sales. Then when it goes back to normal in August and September, that's why we see a number that is over 190. I think it was 192 or 194 on average, which is the level of revenue we get per prescription as we enter into the fourth quarter. So that's the math, that's the explanation. These things happen. And as Santosh also explained clearly, there's no direct correlation in a short period of time between prescriptions and our wholesaler buying. Of course, in the longer run, like over a quarter, it should correlate pretty equally. Fantastic. Thank you, Anders. Given the recent wider backdrop of inflationary cost pressures and the existing focus from the company on cash runway, how easy will it be for you to implement an average of 10% reduction in operating costs from this point? I can take that, Anders. Yeah. I mean, these decisions are never easy to make. They're tough decisions, but they need to be made. We evaluated costs across the business, every single part of the business, and we tried to define what part of that spend directly impacts our ACCRUFeR sales, and so we have had to make some tough decisions. We are scaling back on a few initiatives that would be ideal for us to have, but at this point, we need to reduce our cost basis, and so we've taken steps across the board. This includes personnel. This includes any initiatives that are activities that could help potentially drive business growth that are not directly impacting ACCRUFeR. We have reduced those as well, so is it easy? No. But is it a decision we have taken? Yes. We believe that these are the right decisions to help shape growth. Great. Thank you, Santosh. How are repeat prescription rates progressing? Are physicians continuing to champion or repeat prescribe ACCRUFeR? In short, yes. So for instance, you see that. So the way we work is that each salesperson has a target of 25 physicians, which would be their highest potential customers. So yes, we see continued penetration in that group. We see continued growth. And as Santosh just explained, the split between repeat prescribing healthcare professionals is 70%, while the new are 30%. So we always welcome, of course, new prescribers because that also will continue to drive our business. But I think as we go, we will see that the new prescribers decrease and the repeat prescribers increase. And this is typically what you would like to see because it's easier for a healthcare professional to continue to prescribe. It takes less time for the salesperson to get to that point than to chase the new customers. That takes much more time. We're trying to be very, very efficient, and that's how we measure them as well. We're very, very efficient on how our salespeople spend their time. There's a lot of data to support these things, and we can follow them pretty closely to do that. Santosh, you want to add anything there? No. I think you hit it. I think we annotated a couple of metrics to an earlier question as well. I mean, we see in Q3, 70%-30% split, existing versus new. So the existing continue to believe while we have newer prescribers coming in. So there's continued belief in the physician space within ACCRUFeR. Our challenge, I think, like Anders said, is awareness. We need to increase awareness, and that'll only help us. Thank you, and following on from kind of awareness, someone has asked, is there anything that can be done to get user reviews on online forums to help build confidence in the consumer community, even though it's a prescription drug? Yeah, it is. I mean, so our head of marketing, she's closely following a lot of forums where these treatments are discussed. So typically, as a company, you never interact in that. This is just what we hear. It's called social listening. We do that. We see what their reactions are. Could we, for instance, have a patient ambassador? Yes, that's an initiative we're thinking about, which then you could put on in other digital channels. Typically, what the company does is that then it's very obvious that the person is supporting the product and has done that with support from us. So yes, that's an initiative we are considering to do for next year. Thank you. Can you provide any update on the recent performance of Viatris? Yeah. What you have heard includes Viatris. This is a co-commercialization. The total number of prescriptions is divided between us. So all of what we do is the combined effort of both companies. Thank you. Another question. Even though the U.S. and E.U. markets are roughly comparable, why are sales in the E.U. not showing growth as seen in the U.S.? Basically, I think two factors. It's the number of countries that Norgine are present in and the pricing as well. The U.S. is very different. It's more dynamic from a pricing point of view versus Europe. That's it. In Europe, coming back to previous questions, what is happening with Italy, Spain, and France? Here, a lot of work has been done to make sure to see if we could launch there. I think the biggest difference really is pricing. We are compared typically in Europe in pricing versus the OTC or alliance you can buy, which put us at a disadvantage. The prices are in some markets just way too low. That is, of course, also influenced by reference pricing in Europe. In the U.S., it's very different. You present your case to payers. They can say yes or they can say no if they think this is a therapy that is viable and that they think their patients would benefit from, and thereby they would cover you. And that's basically how it is. And the U.S. market is, in one way, much more complex, but there's so many different plans in the end. But there's no comparison between plans on pricing like there is in Europe between countries or even between states as it is in Europe between countries. So you don't have reference pricing in the same way. So that, I would say, is the main explanation why the difference is between the two markets. Thank you, Anders. I've just got a few more questions. Are the board purely focused on high GDP per capita countries, or are you looking at developing countries too? India has a high addressable market, but low GDP compared to the U.S. We are happy to go to any market where, typically, if you take India as an example, if there is a distributor who wants to take the product to India, we're happy to support that. So yeah, I know I can understand why you asked the question because of the markets we are active in right now. But we are talking to other potential distributing companies about many other markets in the world: Middle East, Africa, Latin America, and so forth. It all comes down to if they see that it would be viable to launch in those markets. So we are completely open to go to any market in the world. Thank you. Do you expect buying by wholesalers ahead of Christmas and New Year to mimic what's happened with the 4th of July weekend? And will this help you hit your target of $31.5 million for 2024 to satisfy the covenant? It's a very good question. And I think, of course, you don't have an exact answer. What happens in the U.S. is that many patients reach their out-of-pocket max, meaning that they paid out of pocket. So now their prescriptions will basically be for free. And that, of course, many reach towards the end of the year. So what typically happens in the fourth quarter is that patients are going to take out their medication. So yes, you may see some of that in the fourth quarter and then see a little bit less in the first quarter because then it restarts and you will have to pay a little bit more to get your prescription. So will that happen? Yeah. Typically, the second and the fourth quarter for most products are the strongest quarters. For us, it's a little bit different because of two things. One, we're not a chronic treatment, as we have explained. And two, we are still on a very strong growth trajectory. So we anticipate to see good growth in the fourth quarter, but we also anticipate to continue to see good growth over the quarters of next year. So that would be my part of the answer. I don't know, Santosh, if you want to add something to the quarterly differences we might see. Yeah. Yeah. I mean, I think I wouldn't add anything more to what you just said, Anders, from a trend perspective. But just to be crystal clear to everyone on the call, we do not force people to buy or not buy at any point in the quarter. It is their decision to buy, and that is their final call, whether they want to buy during a certain period of time or not. So I just want to be crystal clear on that. It is not our decision. It is the buyer's decision. Great. There were several questions submitted by investors about the timing of the raise, but we'd just like to remind investors that we can't disclose any further information that's already in the RNS at this point, but the company will be providing updates in due course, and I think that's it, and I'll hand over back to Lily. There were a lot of questions that kind of had the same message, so we've tried to condense those, and hopefully, that's answered most. Anders, Santosh, thank you for answering all those questions you've had from investors. Of course, the company can review all questions submitted today and will 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? We'd just like to thank you for your interest and thank you for listening to us today and also for all your insightful questions. They all make perfect sense, and if I was in your shoes, I would ask the same questions, and we try to answer them in the best way possible, so if you ever have more questions, you can actually contact us directly or via our company website. Happy to address any questions that you may have, so thank you all so much. Thank you all. Anders, Santosh, thank you for updating investors today. Can I please ask investors not to close the session as you'll now be automatically redirected to provide your feedback in order that the management team can 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.