CMD 2020

Oct 21, 2020

Slides

Welcome to Acelia Pharma's Capital Market Day twenty twenty. I am Magnus Corfurten, CEO of Acelia Pharma. And I'm excited to share our progress with you. And we will also talk about how we are on the path to realize the tremendous potential in our company. Today, at our Capital Markets Day, you will get a status on mangrove development. We will also do a deep dive on the commercial opportunity, where we've made significant progress lately. We will share with you a pre recorded presentation here that have been filled in front of a live internal audience. And later today, we will host a live Q and A session where we look forward to engaging further with you. Acelia Pharma is dedicated to improve the life of people with rare cancer or cancer related conditions. We do this by developing our two unique drug candidates, Mangrel and Oncoral. Both of them are based on solid scientific understanding and a clear opportunity to make a significant and positive contribution to the people in need. We are well positioned to succeed. In Acelia Pharma, we've built a strong and experienced team to lead the development and the commercialization. Equally important, we have established relationships with the world leading doctors and other important partners and stakeholders to ensure cutting edge expertise and capabilities to bring our products to the patient in need. Part of our capabilities is also a solid financial position to fund our growth. We're fully funded for the Mangroil Phase three program. Right now, we are in a transformative period of a cilia pharma. We're in the final phase of clinical development of Mangro, and we're in the process of becoming a commercial stage specialty pharma companies within the next very few years. Our platform for growth is very strong. In addition to Mangro, there is significant potential in Oncrow, and we expect to move into Phase two development next year. As aciliopharma grows, we will further expand our pipeline. We will do so provided the financing is in place, and we have products with a strong fit to our strategy and capabilities. This is a strong platform for generating substantial short- and long term shareholder value. As we communicated in our press release this morning, we have increased the estimate of Mangrove's addressable market to $500 to $600,000,000 annually, which is significantly higher than our previous market estimate. We've done this based on extensive work led by our Chief Commercial Officer, Julie, and she will talk more about it in her presentation. What is important is that you understand it's the new estimate is based on the same patient group as previously. And what we're doing now is we're using new real world procedure data and additional payer and expert input for the pricing and access. There is tremendous opportunity for creating value in Acelia Pharma. In order for us to win, it's important to focus. And right now, these focus areas are excellence in mangrove development. We have a highly experienced team working with world class experts, and they are on track for delivering as previously communicated. Laying the foundation for a huge commercial success of Mangroil. As you will hear today, we're working hard on our preparations to ensure that once we have the regulatory approval, we can move quickly and effectively to make Mangrole available to patients in need. Oncoral plays a smaller role today, but we will soon share the Phase two development plan with you. I'm personally very excited about the work we're doing there, and I hope you'll be too. But let's leave that for another day when we are ready to share it. The transformative phase of Azile Pharma also involves expanding our team to add the right skills and bandwidth as we need it. Obviously, to get ready for The U. S. Launch of Mangrove, we will be building U. S. Commercial and operational team. I'm very proud of the achievements of the team so far. But to me, this is only the very beginning of an amazing journey. I hope you will enjoy the presentations today, and I look forward to engaging with you at our Q and A session at two Central European Time this afternoon. Thank you. I'm Julie Brogren, Chief Commercial Officer at Acelia Pharma. I'm proud and I'm excited to be here today to talk to you about the commercial opportunity of Mangorol. I'm proud because Mangorol has the potential to truly improve the health and life of people living with an unmet need in oncology. And I'm excited because Mangorol, because of this, represents a significant commercial opportunity for ciliopharma. Today, I'll be sharing key highlights on the market opportunity and our progress on the journey to market. Firstly, further market data and analysis has led us to upgrade our estimate of the addressable market for Mangorel to be between US500 and US600 million dollars in our key markets. Secondly, decision makers understand the value of Mangro. And thirdly, our preparations towards launch are progressing as planned and we continue to see a strong case for launching on our own in The U. S. The market potential for Mangorrel is based on a well defined patient population. These are patients who have suspected liver cancer or metastases. Liver metastases are common in many cancer types and are often the cause of mortality. The gold standard for accurate and early detection of liver metastases is liver MRI, adding a drug agent that enhances the image quality, a contrast agent. Patients who have severe kidney impairment are at risk of developing severe adverse events if they are exposed to the currently available contrast agents. This is the target population for mangrove, because mangrove is not associated with the risk of this side effect. The addressable market for mangrove was previously estimated to be between US350 million and US500 million dollars in our key markets, The U. S, The EU and Japan. This estimate was based on solid prevalence data and market research using epidemiology to estimate the patient population. It was also based on a survey among radiologists in The U. S. And on feedback from payers and reimbursement decision makers in key markets. We now have more data, which has led to further validation of assumptions and an upgrade of this estimate. Today, we have announced an upgrade of the addressable market to be between US500 dollars and US600 million dollars in key markets. This upgrade is based on our progress within a number of key areas. First of all, the target population is unchanged. However, we've obtained new data from actual recorded medical procedures, real world data. This data gives us a solid understanding of patients eligible for Mangalore and the number of imaging procedures per patient per year. We've also obtained additional insights from payers and reimbursement experts in our key markets. These insights have helped us advance our understanding of the value proposition of Mangoril to the healthcare system and of the pricing potential in each key market. This new real world data and additional expert input has led us to upgrade our estimate of the addressable market, for which the main driver is an increase in the total number of procedures per year. This is a very attractive commercial opportunity. In line with industry practice, we'll not be sharing further details on these assumptions or data behind our estimate. Our objective is now to be positioned to obtain the best possible access for patients at a price that represents the value of mangrove. We will now focus on completing the SPARGET Phase III study and obtaining regulatory approval. I look forward to realizing this potential for Mancorrel. I will now talk about the value that Mancorrel provides to the healthcare system and what this means for our commercialization. When preparing for a launch, it's key to understand how Mangroyal helps patients compared to other drugs in the landscape. If we look at the landscape of MRI contrast agents, all currently available options are based on the toxic heavy metal gadolinium and they have black box warnings for patients with severe renal impairment. This is due to the risk of developing nephrogenic systemic fibrosis or NSF. NSF is a multi organ and potentially fatal disorder with no treatment options available. This risk exists for both contrast agents that are specific to liver imaging and all other contrast agents available today. This means two things that no contrast agent is currently advised for liver imaging in patients with severe kidney impairment. And it means that Mangorol has the potential to be the only safe and effective liver imaging contrast agent for these patients. Clinical practice confirms that physicians make decisions on liver MR imaging with the risk of NSF in mind. For example, a survey shows that NSF remains the most concerning aspect of gadolinium based contrast agents in MRI imaging. It also shows that for patients at risk, MRI without gadolinium based contrast is a preferred option today, which is in accordance with current guidelines and recommendations from authorities. We have recently held advisory boards and interviews with 50 experts on pricing and reimbursement in key markets. We've asked them to evaluate a number of parameters related to the currently available contrast agents and to the clinical profile of Mangroil. They clearly said that they are aware of the limitations of gadolinium based contrast agents and they agree that MANGOAL has the potential to address these important unmet medical needs. They also provided valuable input on how we can best prepare for dialogue with decision makers to get strong outcomes on pricing and access for patients. In summary, MancoVal has a clear value proposition to patients, to physicians and to the healthcare system. In fact, eighty five percent of clinicians in a survey are likely or extremely likely to use Mangorrel at launch. In my experience, this clear understanding is very uncommon several years before launch. This is because of three things. There is no contrast agent advised for these patients today. Mangalore provides improved visualization compared to unenhanced MRI, which is the standard of care for this patient population today. Three, contrast enhanced MRI can enable early detection, which in turn allows for early intervention and higher survival rates for these patients. To summarize, mangroheal has the potential to be the only safe and effective liver imaging contrast agent for our target patient population. I will now talk about our solid progress and plans for commercialization and the case for building our own commercialization in The U. S. Clear market priorities are key to success. The U. S. Represents the most important commercial opportunity for Mangalore. This is because the number of patients, this is because of the maturity of clinical practice and the reimbursement system in The U. S. EU and Japan represent the next priority markets and we are evaluating other potential markets. For The U. S, the attractiveness and clear path to market provides a strong case for commercializing on our own, I. E, building a U. S. Commercial affiliate. For other markets, the value of Mancoral can be maximized by working with a partner with existing local relationships and expertise. Let me tell you more about this. In our most important market, The U. S, we already have strong relationships with leading radiologists among Sparkle clinical study investigators. We've also partnered with specialists and organizations within manufacturing and radiology. The case for commercializing in The U. S. By building our own affiliate is strong. We can reach priority physicians at launch with a sales force of around 20 FTEs. These will work closely with a cross functional support team. For logistics and distribution, we will work with third parties with existing operations. Building our own commercial team allows us to create an attractive top line and to retain profit in Acelia. We have mapped decision makers in The U. S. With regards to reimbursement, data shows that 70% of mangrove's target patient population is covered under the Medicare and Medicaid programs. The use of mangrove will mainly be at a reachable number of hospitals and clinics. Seven fifty hospitals and clinics handle around seventy five percent of MRI procedures. 400 of these serve seventy five percent of patients with kidney impairment. Radiologists are the most important decision makers on liver imaging contrast agents. Data shows that around 2,000 radiologists perform regular MRI imaging in patients with kidney impairment. Beyond The U. S, The EU and Japan provide the most attractive and addressable market opportunities for Mangro. Our current assessment is that the optimal launch in The EU and Japan and other markets will be to work with partners who have strong local capabilities and relationships with decision makers in reimbursement, pricing and clinical practice. My last topic for today is an update on our progress and plans for commercialization. Our preparations for a strong launch are on track. This year, our focus has been on building global capabilities and building a blueprint for commercialization. We have advanced our plans, our strategies and our priorities based on solid market research. We've also reached supply chain readiness with our first commercial scale manufacturing of Vanquirrel, which we announced in September. And we have worked closely with key stakeholders within the medical community, including investigators in our SPARGLE Phase III study. Next year, our focus will be on preparing and launching a U. S. Organization and on advancing our partnerships in other markets. And we will continue our collaboration with the medical community and we will develop evidence to support the value and pricing for reimbursement decisions. In 2022, our focus will be on preparing for launch execution within commercial and supply chain operations. And it will be to educate physicians more broadly on our clinical data and to reach patients as quickly as possible upon regulatory approval. We expect this towards the 2022 or early twenty twenty three. We know what it takes to reach patients with poor kidney function in need of a safe and effective liver imaging option. We know what it takes to launch Mangorel successfully and the preparations are advancing well and according to our plans. It's been a pleasure to update you today on the market opportunity and commercial preparations for Mangrole. In summary, based on additional data and insights on patient numbers and pricing, we have today upgraded our estimate of the addressable market potential for Mangro to be between US500 million and US600 million dollars in our key markets. Decision makers understand the value of Mangrel and our preparations for launch are progressing well and we continue to have a strong case for building our own U. S. Commercial team. I look forward to updating you as our commercial preparations advance. Thank you. So I will now provide some updates and some more details on the clinical development program of Mangrol, our lead candidate. And one important cornerstone with this program is that we are addressing a clear and significant unmet medical need. Let me start with liver metastasis, which is a major challenge within oncology or cancer care and it's the most common malignant liver lesion. The reason is that many different cancer types tend to develop metastasis in liver over time, and most commonly colorectal cancer, but also breast cancer, gastric cancer and lung cancer. And these metastases in deliveries often the cause of death for these patients, not necessarily the primary tumor. So therefore, it's very important with early and accurate detection of liver metastases and the recommended method there is contrast enhanced MRI or magnetic resonance imaging using a contrast agent or an imaging drug. And this is used at several stages of the patient journey. So it's early at diagnosis or detection of the lesions, is then for the planning of the treatment of the patient. And then subsequently for the follow-up of the patient, which could go on for many, many years. Now the currently available contrast agents on the market are based on gadolinium, which is a heavy metal. However, patients with impaired kidney function should not receive gadolinium. And the reason is the risk of serious potentially deadly side effects. So therefore, the regulatory agencies, thus including FDA in The U. S, but also EMA and the Japanese regulators have implemented warnings and restrictions. So basically these patients lack a contrast agent today. The standard of care for these patients is an MRI without a contrast agent. So again, this is the very specific unmet need that we are addressing with Mangroil. So Mangrol is not only advancing the liver imaging, but it's at the same time addressing the unmet need. Mangrol is an oral manganese based liver specific contrast agent. And we are specifically targeting the patient with severe renal insufficiency, because these patients are at risk using the currently available contrast agents. And this unmet need is also validated with the orphan drug designation that we have from the FDA. And importantly, our SPARKL, our Phase three study is now ongoing. And the scans to the right illustrates how Mangrel works. So to the left, you have an unenhanced liver MRI without a contrast agent. To the right, you have the same patient after administration of Mangrel. So this is a mangrol enhanced liver MRI. And the liver has taken up mangrol and the liver appears bright. However, there's one dark structure on the scan that's not visible without a contrast agent, which is indicated by the red ring. This is a liver metastasis. And this illustrates the importance of using a contrast agent, because now being detected this metastasis can also be removed and that would significantly improve the prognosis for this patient, the chances of survival. This slide illustrates the positioning of Mangorel. So today, patients with normal kidney function can receive gadolinium or gadolinium imaging drugs. However, patients with poor kidney function don't have an imaging drug today. So in the future, tomorrow, Mangrove can address this medical need and fill this empty space. So importantly, we are not competing, Mangrove is not competing against gadolinium, but filling an empty space for these specific patients. And we estimate that roughly four percent of patients that require a liver MRI would fulfill the criteria for severely reduced renal function and would then be addressed by Mangril. So Mangril aims to be the standard of care for liver MRI imaging in these patients. And importantly, we are the only imaging liver specific imaging drug in clinical development today. So we are way ahead of any potential competition. So I mentioned that our Phase three study SPARKL is ongoing. We already have very strong clinical proof of concept through six different Phase one and Phase two studies with very consistent results both for efficacy and for safety. And these results were confirmed and repeated by an independent re analysis by an independent radiologist and expert reader. And these results showed highly significant results on very important typical imaging endpoints. In addition, three percent more lesions were detected with Mangrole as compared to without Mangrole. So the strategy for the Phase three development as you see to the right on the slide here is to repeat and verify confirm this data in a larger study. And for the primary endpoint, we're using lesion visualization, which had very significant results in the Phase two program. It's lesion visualization, co primary endpoints is lesion delineation, sharpness of border and conspicuity, which is contrast compared to background. And given the Phase two data here, we believe that we have very good chances to have a successful study. This is a global study up to 200 patients and importantly the study design has been agreed and discussed with both FDA and EMA. We're comparing against unenhanced MRI, which is standard of care for these patients today, not another contrast agent, which also increases the chances for success. The follow-up is relatively short for each patient, it's just a few days, which means that we will have the final study result relatively sooner than a conventional Phase three study. So it's a global study and the patients are recruited at approximately 40 to 50 clinical sites and some of them are listed on this slide here. And you can note that these are top institutions. And that means that we also will have the leading expert and the leading opinion leaders involved in the program already now. So we're building a strong relationship with these opinion leaders and we have a very strong support from them for this program. And we already now are creating awareness about MAGORD through this large clinical study. And we believe that the participation of these experts and these sites validates the unmet medical need that we are addressing with Mangalore. So finally, just a few words about the timeline. We have made very good progress in spite of the challenges associated with the COVID-nineteen. The Phase one and Phase two are finalized. And earlier this year, we recruited the first patient in our Phase three study SPARKL. We anticipate that the final results will be available second half of twenty twenty one, So that's next year. And then we're aiming for filing early twenty twenty two. And then we are ready for the market late 'twenty two or early 'twenty three. The preparation for the market we will hear more about during the next presentation today. So thereby I thank you for the attention. A quick note on CRA. We're a publicly traded global strategy consulting company with our headquarters in Boston, Massachusetts and multiple offices across The US and in Europe too. Within CRA, there are more than 220 consultants dedicated to the life science industry, making it one of our largest practices. CRA has a wide variety of experience conducting engagements with both major life science companies as well as with smaller companies that might be bringing their very first product to market. From your perspective, what are the most important factors for successful drug commercialization in The US? First, I'd say that a company needs to have a solid understanding of their product and what makes it unique among the competition. Second would be developing an in-depth understanding of their customers. Third would be to develop a pricing and market access strategy, which is closely aligned with their product's value. Then as we get closer to launch, it's critical that there's alignment between the account teams that call on the access decision makers and the sales force that calls on the prescribers. Finally, all of these things need to be monitored closely, and any surprises might require modifications to the commercialization plan. Could you tell me more about developing the product? The first step in developing a product is understanding the product positioning. This entails understanding how the product compares to currently available options and where it can provide the most value in the treatment pathway. There are multiple ways a product can establish a niche. For example, does the product work best in a specific patient subpopulation or in patients with intolerance for certain medications or classes of medication? Once the positioning has been determined, the next step is to understand how to socialize the product benefits through brand messaging. With prescribers, these messages usually focus on sharing the clinical benefits that differentiate the product. Within the access decision maker space, though, the messages are a bit more diverse, because the group of stakeholders is diverse as well and include managed care organizations, hospitals, and even imaging centers. The U. Healthcare market is known for its complexity. How do you define the customer in this complex landscape? Defining the customer begins with first understanding the patient's journey. Each disease area is unique and shows variances in its customers and access decision maker dynamics. In studying the patient journey, it's necessary to understand all the key decision makers and the types of decisions that they make as well. Understanding the decisions and different types of customers along the customer journey allows us to unidentify key influence points where the unique value of the product can be turned into a competitive advantage. A savvy manufacturer might use these influence points to form the foundation of the customer engagement strategy, where the advantages are delivered as tailored messages that speak to the key questions in the key decision maker's mind. How does a company go about establishing a pricing and market access strategy in The U. S? The U. S. Is a free pricing market, which means that manufacturers are allowed to choose their price. This puts the responsibility on the manufacturer to find a price that will provide the desired market access for patients. Market access is a combination of clinical value, the price, and ultimately the restrictions that are placed on the product by access decision makers. To develop a sound pricing and market access strategy, we pair our understanding of how the money flows between the stakeholders with the value offered by the product. This provides us with guidance on how we can communicate the product's value to each stakeholder given their motivations and their needs associated with the product. An additional tool we might use sometimes is a contracting strategy in order to adjust the product economics within a particular type of stakeholder. Where should a company be two to three years prior to launch? Ideally, at that point, the commercial team owns an overview of the product positioning options within the current marketplace and has a solid understanding of the niche filled by their product. Also, key decision makers along the patient journey, such as the payers, the providers, the patients, the caretakers, should be mapped out, and they should have a solid understanding of the financial flows between these decision makers. In other words, they should really have a thorough lay of the land. In terms of next steps for a manufacturer, they're likely finding ways to penetrate into these niches through key influence points and developing a value story for the most important access decision makers. Welcome to Acetia Pharma's Capital Markets Day twenty twenty. We look forward to updating you on Mangrove's market opportunity and our commercial preparations. This morning, we released presentations from members of the executive management team and an independent U. S. Commercialization expert. We hope you found the presentations interesting. And if you haven't had time to look at them yet, they will remain accessible on our website. So with me now in this Q and A session, have the executive management team. We also have Polot Stjengren, who will moderate this session. Before getting into the Q and As, just want to do a brief recap of the messages that we sent today. MAGROL is in Phase III development. And in parallel with that, we're doing a lot of commercial preparation. This morning, we sent out a press release upgrading the addressable market estimate to 500,000,000 to $600,000,000 annually. We've done this based on extensive commercial preparation work, and Julie has presented that in her presentations, which are on the website. So with that said, we continue to make progress, and we expect to launch Mangrole in The U. S. In the 2022 or first half of 'twenty three, which is consistent with our previous guidance. So that was sort of the key message. And now I'd like to hand the word over to you, Sjokoda. Thank you, Magnus. So now we're having the Q and A. Feel free to ask any questions either via telephone or if you send an e mail to mwacelia dot com. We have the whole management team here, as Magnus said, but we also have CFO, Christian Borboss, for questions. So I'll start off with you, Julie. You are the star of the day today here with all the research you have done. You gave an update on the market. Could you elaborate on the changes? The patient population hasn't changed, but the other two parts. Thank you. Yes. So as you said, our target patient population is the same, but we have new real world data based on actual medical procedures and number of patients and the medical procedures per patient. That's one part. We also have additional insights from experts in pricing, reimbursement and market access in our key markets where we've talked to around 50 experts. So that has led us to upgrade our estimate today. The main driver of the estimate is the number of imaging procedures in our target patient population. And with regards to pricing, there are no major changes to our previous estimates. So that's where we are now. It's exciting to see these upgraded numbers. And just one more note is that it does not include the market growth from now on to launch. How do you look upon market growth? Do you have a figure for that or? If we look at volume and prices from the insights we have, I think we are working on estimates between 54% annually in market growth. 45%. 4% to five percent, right. Four to five percent. First question to you as well, Karl. COVID is everywhere. How has that affected your study, Sparkle? Yes, it's a fair question given the current situation and it has affected the timelines already. And we communicated that earlier this year. But I think as for anyone in the industry, we have to adapt to current situation so that the clinical research can continue and it does. So, we have to learn. And for example, in addition to the regular precautions in society, many of the meetings that we have and interaction with hospitals, for example, that were previously face to face can now be done virtually and online. We're all learning. And I think in our case, importantly, patients are still there and the medical need is still there. And in particular, our study design, I think is less susceptible for disruptions because as I mentioned in my presentation, the follow-up for each patient is very short, only five days. So that's very unique. So I think we are in a very good position here. Having said that, this is our estimate today. Should things change, we will communicate that, but I don't see that. You feel confident in the timeline you have now? I do, yes, yes. I do. Great. And Christian, the question to you, you can understand what it is. You had $240,000,000 in cash last time you communicated. How long will that last? So the current cash position will take us into 2022. And that is important because we expect to have Phase III data in the second half of twenty twenty one. So the current cash position takes us beyond this critical clinical milestone and that's very important. And then what happens next? I mean, I guess it doesn't cover the commercialization that Julia has talked about in The U. S. What do you do then? Yes. So our game plan is to commercialize by ourselves in The U. S. And also build an own organization. That will require additional financing. And assuming we have positive Phase III data, then we think it's clearly feasible to obtain financing at that stage. So once you have the data, then you're in an even better position, Magnus, of you seem to have a great team in place here. What's your job? Well, my most important job is having the right team. So I've done well on that and not just the people who are on the stage here today, but everybody in the Cellini Pharma is doing a great job and also all the advisers and people we work with and the doctors in the studies. So I think that's really the most important thing because, as you can see, we have, as Julie presented, we have an attractive market. We have an attractive clinical trial design that Karl and his team are moving on full speed with, and we have a good cash position. So we are in a good position. Probably, you would say, challenge is, as we grow, how can we continue to recruit very good people that can join our high performing team. I think that's probably my biggest challenge right now. Yes. That was one of my questions, actually. What is the biggest risk in this? But that is you're not worried about the study, you're more worried about recruiting the right people? I agree. I think we have very as Karl mentioned, we have very good data from Phase one and Phase two. And we have similar endpoints in our Phase three. I think we're working with some of the best radiologists in the world in the study. I think we're in good shape there. So I think it's more continue to attract great people to the team. Let's see if we have any questions from the telephone conference. Is there anyone there? Operator, please? And while we have that pause, I guess we can continue with questions in the room. Karl, I'll start with you. You have a vast experience from previous studies. So you told us you're confident with the timeline. How certain are you about a positive outcome in Sparkle? So, yes. So, thing I learned, my experience there is you can never take anything for granted. There's never 100% security that you will succeed. However, having said that, I could say that in our case, given as you mentioned the Phase one data, Phase two data we have and I described in my presentation and given the study design, given that we are comparing to unenhanced MRI not another contrast agent for example, I think the chances are unusually good with our study and our program compared to many other programs I've been involved with. But again, there's never a guarantee, but I think in our case, have very good chances. I happen to know you were involved in Wilson. I guess That that is a good was also a good case. That was a good case. And you've recruited the good people. I go for the best. You go for the best. So did we have any questions from the telephone conference? Good. So Julie, again, the 500,000,000 to €600,000,000 and it's going to grow with 4% to 5%, can you say anything about the division between the regions that you're targeting, The U. S, The EU and Japan? So The U. S. Is by far our biggest opportunity. That's represented by the size of the patient population, the maturity of clinical practice in Imaging and also the market access and pricing opportunity in The U. S. And then we have Europe and Japan also, interesting markets based on the size of the population, again, in clinical practice and reinvestment. So by far, U. S. Is the most important opportunity. And you're planning to launch yourselves in The U. S. Because that is the most important. Can you say anything about the EU and Japan? Why did you land in this decision? Might you change your mind? I can open up with some comments and then hand over to Julie. So I mean, to succeed, we need to be extremely focused, and we are a small company. So if we succeed in The U. S, which is the biggest market, we think that's absolutely feasible. It will be a hard work, but I think we will be successful. To succeed there will require all everything we can do. And the best thing there then is to find partners for to access patients in other geographies, such as Europe and Japan. But maybe you can No, absolutely. As you said, to succeed in The U. S, it's going to take a lot of focus from us. And in Europe and Japan, we see that a partner with existing operations, existing relationships and experience with decision makers and pricing, reimbursement and in clinical practice is going to help such a partner be successful. So we believe that, that strategy will maximize the value for Acelia also in those markets while we focus on The U. S. And, of course, help the partners we will have in time. In terms of partners, do you have any preferred what are the prerequisites for being a good partner to Acelia on this? I think the well, always, when you do I can start up and Julie can expand on that. But I think when you do a partnership, it's absolutely critical that it's a profitable venture and a mutually enjoyable venture for both parties. I think that is the prerequisite. Maybe, Julie, you want to expand on the capabilities of what we're looking for in a partner? Yes. Think it depends a little bit on the market. In Japan, there's also a process with local clinical data and local regulatory approval where a partner also would have experience in that. Otherwise, it's really about existing relationships and experience with key decision makers and the dynamics in each market. So hopefully, it's someone who works in a related field, the therapeutic area, the decision makers and so forth. And in Europe, again, also synergies in the, you could say, the sales force and medical support and so forth. I think it's important for a mutually, you could say, beneficial case for a partner and for us. Karl, coming back to you. Today, you're upgrading the size of the market, but isn't it so that the prevalence of NSF has gone down? So how do you get these two together? The market is growing, but NSF has been shrinking. Right. So, NSF or nephrogenic systemic fibrosis, which is this very serious side effect of gadolinium that could happen in patients with poor kidney function, it is rare, first of all. And it's partly rare because of the restrictions that are on the market today. So it is a rare condition. Having said that, still more than three thousand cases were reported to the FDA only since 02/2006. And there are recent cases as well. So it does exist. And importantly, the restrictions and warnings are still there for the currently available contrast agents. So the unmet need for a safe alternative is there today, I would say. And I guess the prevalence has gone down because they are untreated. So they don't get guardilinium and that's exactly. That's what yes, you're right. And that's what I said. It's a consequence of the warnings and the restrictions that are there. So they're left with nothing Yes. Yes. That's correct. But it sounds so good. I mean, if I went into a clinic and they said you were going to have guardilinium, isn't it so that this could have other places of being used than in other patients than those without renal impairment? Yes. I mean, we're focusing on the patients with severe renal impairment who are at this risk of this devastating side effect of the existing category of products. And that's how we're developing. And Karl, maybe you want to expand on so we're focusing on the on our development program. Yes. It's partly strategic decision because focusing on this rare population, then you can develop this as an orphan drug. You can get an orphan drug designation from the regulators. And that gives you certain advantages when you do clinical development. For example, in from conventional drug for a larger population, you're usually required to do two Phase III studies, larger studies. If you have a rare indication or designation, then one study is sufficient for example. So, a number of advantages doing that way going that way. And for example, if we were to compare to another contrast agent, which would be the case if we go for a broader indication, then that would be a completely different development program, a completely different study. It would take longer, for example. So I think this is in the best interest of our particular patient is to go this way, the patients in need. For the patients in Yes. And also to expand on that is that we have with the data we have, we understand that based on everything we know that this is safe for this patient population. And we want to get our product on the market and be available to these patients as soon as possible. And that is by executing on this strategy. You said in your presentation that you're the only imaging drug in clinical development. Would you say and that you're then way ahead of competition, Why is that? Is it because the market is too small or is it because you mangrove is so good? Yes, it's maybe both. No, it's a very fair question and I think there are probably several reasons for that. One is that this unmet need, the risks of gadolinium in this particular patient group hasn't been known for that long. It's only ten years or so that this unmet need has been known. So that's one reason. The other one I think is that this particular market, our market has been underestimated. So it was more these are so few patients, so why bother about them? And then what we have done in Assilia, I think that's very unique. We have done a very thorough analysis of what is the real market here. We have defined the business case basically for this. Today is an example of that. So there is a real case for our compound here and there is a business case for that. So that's the second. And the third one, I think is that there has been a relatively recent interest and incentive treatment for rare indications or rare conditions. And that has been traditionally for treatments for drugs, but it also applies to diagnostics like Magrav. So I think we're taking of that as well. But I think those are the three main explanations. And this orphan drug designation that you had in The U. S. Is obviously very important then. Is there something similar in Europe? Or how does that work? Do want to? Yes. There is a similar orphan drug concept in Europe. At present, we have the orphan drug designation from the FDA in U. S, which is the most important market. That's a big achievement. In Europe, the legislation is somewhat different. And as of now, we don't have it in Europe. We may get it or we may not get it. That depends on the future developments. But it's not as critical for us in Europe. So we are in good shape regardless of whether we get it or not. And can you talk about how you when you get the Phase III results from Sparkle, you will go for U. S. First? Yes. Can you say anything about any application to Europe? Yes. No, it's also very relevant and complex. It's good question. It's a complex answer. So you're right, we will focus first on the application to The U. S. We will depending on the situation, if we have a partner on board, what is the strategy for Europe, that will determine what will be, you say, the filing date in Europe. Also, when you do apply for drug approval, you submit a very massive amount of data and documentation to the authorities. And they will give you a lot of questions during the examination period. And if you are answering questions from two agencies in parallel, you will get not only busy, but extremely busy. So there are lots of considerations that we weigh in. But really, the focus is on being successful in The U. S. If we are successful in The U. S. With mangrove, that's going to be tremendous for us. We also want to get to the patients in Europe, Japan and other countries. But we think the most important thing is to succeed in U. S. And then make sure we can get out to the rest in wave number two. And coming back to what Karl said about this is a fairly new market that you basically have developed in some way, you could say, or are about to develop. Are you worried you will get competition now that it's even bigger than you said before? We might. And if we do, that's because we are successful and people see there's a real unmet need that we are addressing. So I think when if and when we see competition coming forward, it's a sign that we have been successful. So I think that's a good starting position. I think it may happen. But then again, the development time lines and drug development are so long so that if somebody starts on a competing product with a similar profile, they will get to market maybe ten years after our launch. So I think it's a very unique situation actually to be in. Is there anything else we could be worried about? I mean, there's so much technical development. Are you worried about something like that? We're not worried, but we are aware of it. I mean, the two things is the software thing and it's also the quality of the upgrade of the cameras that could create better qualities of the images. But that's not I don't see that as a negative thing because given the mechanism of action of mangrove, think it would be hard to add on to that. So if you have better quality of the image, if you can then add on mangrove on top of that, it will only increase the quality of this. So I don't see that as something negative necessarily. I think there will still will be a case for a contrast agent. That's what I'm saying. I agree with that. And I think it might even be a positive because when the software algorithms improve and they can see more and get more information out of a high quality image, which we can provide with Mangro, then it may even expand potentially in the future on the kind of information you can get from an Librium MRI. So it's not only something that is a risk on the downside, it's actually also an opportunity for doing something better for the patients in the future. That's reassuring. So do we have any more questions or any questions from the telephone conference? Operator, please? At this moment, we don't have any questions. We don't have any. Magnus, I think I'll leave over to you for any closing remarks. Yes. So thank you, everybody, for your attention and taking time to be here with us on our Capital Markets Day twenty twenty. We hope you found the update that we've given interesting. I can assure you that we are working very hard and are very dedicated to moving our company forward, both Mangrol and Oncrawl. And we will look forward to updating you on the progress that we make as we move forward. Thank you.