Ascelia Pharma AB (publ) (ACE) Earnings Call Transcript & Summary

Thank you, and welcome, everyone, to the webcast for Ascelia Pharma's Q1 report for 2025. On this call, we will be making forward-looking statements. On today's call, we'll start with the recent key events and then head into our portfolio update before moving to financials and priorities ahead. After the presentation, we will open up for questions. As mentioned, I am Magnus Corfitzen, CEO of Ascelia Pharma. And with me today, I have Julie Waras Brogren, Deputy CEO; and Andreas Norlin, Chief Scientific Officer. At Ascelia Pharma, we identify, develop and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We have 2 drugs in our pipeline. Orviglance is in registration phase as we have successfully completed the pivotal Phase III clinical study, SPARKLE, and we are preparing the NDA submission. Orviglance has orphan drug designation from the FDA and is targeting an addressable market opportunity of $800 million globally. Oncoral is ready to start Phase II in the treatment of gastric cancer based on encouraging results in Phase I and a high level of unmet medical need. We're based in Malmo, Sweden and are listed on NASDAQ Stockholm. The first quarter of 2025 was eventful as we continued our preparation for the submission of the Orviglance NDA. I'd like to briefly mention some of the key highlights. The interest in the scientific and medical community continues to be strong. And in Q1, we announced the acceptance of 3 abstracts here of 2 oral presentations at ESGAR, which is the European Society of Gastrointestinal Radiology, which took place this weekend in Amsterdam. After the end of the quarter, we announced acceptance of a poster presentation at the ISPOR conference in Canada, which is also this week about the burden of disease for the Orviglance target patient population. In February, an extraordinary general meeting was held to approve an option program to replace a program that expired late 2024 without being exercised. In Q1, we also announced the outcome of our meeting with the FDA. Andreas will talk more about it. And we are, as mentioned, very pleased with the results from the meeting where FDA provided clear and constructive feedback so we can finalize the NDA according to their interest. The TO 1 warrants were issued in connection with our rights issue in the fall of 2024. And the exercise period was in the first half of April, so after the quarter. There was very strong interest and 96% of the warrants were utilized and the gross proceeds were approximately SEK 43 million. Last week, we held the Annual General Meeting and the bulleting has also been communicated. We're very excited about Orviglance, and here is why. Orviglance is addressing a well-defined unmet medical need for a subgroup of people living with cancer. This is an $800 million global market opportunity, and Orviglance is a first-in-class product to target this and has orphan drug designation from the FDA. We have strong data from 9 clinical studies and manufacturing has been upscaled to commercial scale. With the strong Phase III data, Orviglance has now been advanced to regulatory phase, and we're preparing for an NDA submission. We are pursuing some important value creation opportunities with Orviglance. The first objective is a timely submission and approval of Orviglance with the optimal label. The key steps on the way are that we completed the SPARKLE clinical study report in early Q4. We've also announced the outcome from the meeting with the FDA here in Q1 as planned. And the FDA feedback is being incorporated into the NDA and the submission is on track for the middle of this year. We expect the most likely timing for the submission to be in the first half of August. The second objective is to progress Orviglance for commercialization. And the key activities are to continue to advance the launch readiness by ensuring the manufacturing and supply chain is ready for launch as well as working with medical experts, including key opinion leaders, payers, patient advocacy groups and other key stakeholders. The other key objective is entering into a commercialization partnership for Orviglance. I'm very happy with the progress we're making in Ascelia and the efforts made by our team to ensure we will meet our objectives and create value for shareholders. We will start the portfolio section of our presentation with Orviglance, and I'd like to hand the word to Andreas.

Thank you, Magnus. Orviglance is a first-class liver MRI contrast agent, which addresses a very specific unmet medical need for which there are no good alternatives available today. Adequate visualization of liver tumors and metastasis is critical for making the right treatment decisions and contrast-enhanced MRI is the gold standard procedure for examination of patients with suspected or known tumors or metastases. The most used contrast agents are all based on the heavy metal gadolinium. In patients with severe kidney impairment, use of gadolinium-based contrast agents has been associated with an increased risk of a very severe side effect called NSF, nephrogenic systemic fibrosis, which may even have lethal outcome. Both the European and the U.S. regulatory authorities have for that reason issued warnings for the use of gadolinium-based contrast agents in this group of patients. The consequence is that patients with impaired kidney function typically will get an MRI without contrast, which will result in liver images of suboptimal quality with a risk for that their cancer is not managed in the best possible way. We envision that Orviglance which is based on manganese will address this unmet medical need and in the future, become an efficacious non-gadolinium contrast agent for liver cancer patients with impaired kidney function. Our clinical Phase III study in SPARKLE completed last year has clearly demonstrated that Orviglance enhanced liver MRI is superior to unenhanced MRIs. The primary efficacy evaluation in the study was done by 3 independent radiologists or readers, and they all show that visualization of focal liver lesions when having access to both enhanced and unenhanced MRI images was significantly improved compared to visualization of lesions in unenhanced images. And the statistical analysis demonstrated p-values below 0.001 for all the relevant tests of the improved imaging. Furthermore, the results from secondary endpoints consistently demonstrated the superiority of Orviglance over unenhanced MRI with no analysis favoring unenhanced MRI. No serious adverse drug reactions were observed and more than 80% of reported adverse reactions were mild and short-lived, primarily related to the gastrointestinal tract, including nausea, diarrhea and vomiting. And the safety results from this vulnerable patient population were consistent with previous studies. All in all, the study met its primary objective by demonstrating that Orviglance significantly improved visualization of focal liver lesions while being well tolerated by the patients. With SPARKLE, we have completed the clinical development and the comprehensive clinical program includes a total of 286 patients and healthy volunteers in 9 clinical studies. Taken together, these studies have consistently demonstrated positive efficacy and safety of Orviglance. And with the Phase III SPARKLE study confirming the superior visualization of focal liver lesions in the target population of patients with severe kidney impairment and an adverse event profile consistent with what we observed in the other studies, we are moving ahead with the submission of the marketing approval application, the NDA for Orviglance. In March, we announced that we received the final minutes from a meeting with the U.S. FDA, at which the authority provided clear and constructive feedback on the preparation of the NDA file. The meeting was an important step towards the NDA submission, and it was held to present our plan for the NDA and agree on details pertaining to, among other things, the analysis and presentation of the clinical data, manufacturing documentation and generally how to organize the data and documents in the file. We are implementing the feedback by the FDA to the NDA file and continue to aim for the submission mid-2025, most likely in the first half of August. In summary, we are now taking the last step towards the NDA submission. Having completed the reporting of the SPARKLE study that shows that Orviglance provides superior imaging compared to unenhanced MRI and successfully completed the meeting with the FDA, we focus our efforts on making the NDA file ready. We continue this work according to our plans and anticipate submission mid-2025, first half of August, most likely. And after submission, we expect a standard 10-month review period from the FDA. So with that, I will hand over to Julie.

Thank you, Andreas. The addressable market for Orviglance has a global value of USD 800 million annually. The U.S. represents almost half of this. This market opportunity for Orviglance addresses the unmet need for a well-defined patient population, cancer patients who need liver imaging and who also have severely impaired kidney function, where gadolinium may not be recommended. Our strategy for commercialization is to launch through partners. This strategy supports our ambition to secure the optimal balance between future revenues and investment required. Our focused, ambitious launch strategy and plans built on advanced market insights are in place to support this partnering strategy and the launch. As mentioned, the U.S. is our largest commercial opportunity. In the U.S. alone, our real-world data, i.e., data from realized procedures in our target patient population show that every year, 100,000 abdominal imaging procedures are performed in around 50,000 patients that fall under the black box warning for gadolinium contrast agents. This is about 4% of people with cancer undergoing abdominal imaging. The well-defined patient population with a clear unmet need also drives an attractive value and pricing opportunity. And we have extensive input from market access and pricing experts with whom we've tested different pricing levels and collected insights on the evidence needed to support access and reimbursement. And we have investigated pricing and access benchmarks of other innovative diagnostic drugs in the U.S. In clinical practice, 90% of health care professionals are concerned with issues related to gadolinium contrast agents, including the severe side effects associated with our target patient population, NSF. In fact, 16% of providers have experienced cases of NSF in patients exposed to gadolinium. These insights come from market research with 270 U.S. health care professionals and answers from radiologists, nephrologists and oncologists. The insights confirm the concerns with gadolinium in clinical practice and the unmet need for Orviglance. When speaking to experts, whether in radiology or nephrology, they confirm that an alternative to gadolinium for our target patient population would address concerns of today. Beyond the risk of NSF in kidney impaired patients, gadolinium is well known to be retained in the brain and other tissue in all patients and scrutiny over the possible safety effects is a key concern of regulatory and medical bodies. It is also well known that gadolinium is excreted via the kidneys in urine. And because it's difficult to remove in our sewage system, it's discharged into the environment and into our drinking water. There's an urgency from regulators and medical bodies to find a viable alternative to the growing use of toxic gadolinium, an alternative that is not associated with these potential safety and environmental concerns for patients and for the environment with gadolinium. And the industry is responding. Recent developments from the large gadolinium manufacturers are focused on smaller doses of gadolinium and there's even an early-stage injectable manganese contrast agent, which is not liver-specific like Orviglance. A more recent point of concern for gadolinium contrast agent manufacturers is that almost all gadolinium is today exported from China. Beyond having seen significant price increases over the past years, there's a more urgent concern about supply continuity and impact of trade barriers and import taxes for these manufacturers. In short, the momentum for an alternative to gadolinium is getting better and better. And we are excited that we have a head start and that Orviglance is expected to be a first-in-class to lead a future with less gadolinium and improved outcomes for our target patients. The go-to-market strategy for Orviglance is to launch with commercialization partners, and our dialogue with potential partners is progressing. This supports our objective to secure the optimal balance between future revenues and investment required. This strategy also allows us to leverage commercial capabilities already established by a partner. We're also working in parallel to ensure that Orviglance and a partner is ready to launch upon approval, for example, that manufacturing is ready for the first product launch. We are excited to see the successful acceptances of SPARKLE data for presentation at major scientific conferences. Data around Orviglance has been presented in total in 4 oral presentations and 4 abstract presentations at major conferences thus far underscoring the interest of Orviglance in the medical and scientific community. This week, data from SPARKLE was presented at the European Society of Gastrointestinal and Abdominal Radiology, ESGAR in 2 presentations by leading radiologists. Another key stakeholder group for Orviglance is payers and policymakers. A poster with real-world data on the vulnerability and unmet needs for the target patient population of Orviglance was presented this week at the Professional Society for Health Economics and Outcomes Research, ISPOR. I will now hand it over to Andreas to talk about Oncoral.

Thank you, Julie. Yes, let's talk about Oncoral, the other asset in our development portfolio. Oncoral is a daily tablet formulation of irinotecan, a well-established intravenous chemotherapeutic agent. The daily tablet formulation enables a frequent low-dose dosing regimen that could offer potential advantages on both efficacy and safety compared to the infrequent high-dose intravenous administration used today. We have completed a Phase I study, which demonstrated a promising safety profile and an uptake of the drug after oral dosing consistent with the daily dosing concept, and we are now planning for taking Oncoral into clinical Phase II. The objective is to generate clinical proof of efficacy data in metastatic gastric cancer in combination with Lonsurf, another oral cancer treatment approved for gastric cancer. Animal data has demonstrated a synergistic effect of irinotecan when combined with Lonsurf, which makes this combination very interesting. The planned Phase II study is designed to study Oncoral plus Lonsurf against Lonsurf alone. The study will randomize approximately 100 patients and involves a clinical collaboration with Taiho Oncology, the developer and marketer of Lonsurf, who will provide clinical advice on Lonsurf for the study. Irinotecan is a well-established chemotherapy with recognized antitumor effect in solid tumors. Our strategy is to start Oncoral development in gastric cancer, which is today a $3 billion market. For these patients, there is a high unmet medical need for improving outcomes, and there is an opportunity for an orphan indication. We also see opportunities for developing Oncoral in other solid tumor indications where a daily dosing tablet formulation can demonstrate an attractive efficacy and safety profile. Irinotecan as an IV formulation is already approved in colorectal and pancreatic cancer. And in addition, irinotecan is clinically demonstrated and recognized in guidelines for other cancer types. We are assessing these opportunities as part of our ongoing strategic planning for Oncoral. So back to Julie again.

Thank you, Andreas. I will now move to the update on our financials and our priorities ahead. We were very pleased to see the successful outcome of our TO 1 warrant series exercise during the first half of April. With a subscription rate of almost 96%, the proceeds reached SEK 43 million before costs. The successful warrant exercise strengthens our financial flexibility. We now have a cash runway to at least the end of 2025, well beyond the NDA submission and repayment of the SEK 20 million loan to Fenja with a reserved cash for a potential repayment of the SEK 7.5 million convertibles at the end of 2025. This run rate excludes financing from partnering. In Q1, our operating result was a loss, i.e., cost of SEK 20.1 million. Costs are at a similar level compared to Q4 2024 with a continued focus on the NDA submission preparations. At the end of March '25, we had SEK 57 million in the bank. This excludes the SEK 43 million gross proceeds from our TO 1 warrants exercised in April 2025. As mentioned, our cash runway now reaches at least the end of 2025, and it includes a reserve for the potential repayment of the remaining SEK 7.5 million Fenja convertibles at the end of the year. And as mentioned, it also excludes financing from partnering. To wrap up, we have substantial value creation opportunities ahead for Orviglance and for Ascelia Pharma. With Orviglance, we are bringing to market a first-in-class diagnostic drug addressing an $800 million market for patients with a high unmet need. We have 2 key objectives. First, a timely submission and approval of Orviglance with the optimal label. The key steps on the way are the completion of the SPARKLE clinical study report, a milestone we achieved early November last year and which reinforced the successful study outcomes of the Phase III studies, primary and secondary endpoints and supports the NDA process. In March this year, we communicated positive outcomes from our meeting with the FDA in advance of our NDA submission. and we plan to submit the NDA in the middle of the year, as previously guided, and it will most likely be during the first half of August. Our other objective is to progress Orviglance for commercialization for patients in need by entering into a partnering agreement for the launch and by securing that a partner and Orviglance is ready for launch by approval. All in all, we have progressed well in Q1 with the continued preparations for the NDA submission of Orviglance and a successful meeting with the FDA. We continue to progress our partnering discussions for the commercialization of Orviglance. And in terms of financing, we reached a successful 96% subscription rate for our TO 1 warrants, providing SEK 43 million gross in additional financing. We look very much forward to executing on the opportunities ahead for Orviglance and for Ascelia Pharma in 2025 and beyond.

That completes our quarterly presentation, and we would now like to open up for questions.

[Operator Instructions]

Yes. We have received some questions here that you have added. So we will respond to those. So one question is on the timing of when we can expect a partnership. Julie, do you want to take that one?

Yes. We want to enter into the partnership agreement when we get the right terms and when we have found the right partner. So of course, we cannot comment on this in detail. We want a partner who can also be ready for launch. So of course, many of you, I think, are hoping that it is in this year, of course. And we are really excited about the progress on the partnering discussions.

So another question on this topic is whether we are looking for U.S.-only partner or a global partner. Can you have any -- share any thoughts on that?

Again, it depends on the specific terms and the type of partner. U.S. is by far the largest single opportunity. So a lot of -- so that is really a key to start with. Then is it a partner with the global capabilities? It makes a lot of sense that it's a global partner. If the best terms for the U.S. is with someone who is focused on the U.S., then we can find partners for other markets. But there are synergies in a global launch for sure, but also other opportunities if it's not that direction.

So we have a question here on -- in terms of -- We have a question here on the time plan for the rest of Orviglance and whether any geographies would be first. I can comment on that. I think as we have communicated, U.S. is first, and we want to do other geographies with a partner. So the timing and priority of the other markets depend on the partnering discussions and the dialogue with the partner. So we don't have any sort of specific guidance at this point on those time lines. Then we have another question, which is the -- if we provide a ballpark cost of Oncoral Phase II and Oncoral Phase III and whether Taiho will cover some of the cost. I think maybe that could be a sort of a broader question responding to sort of what is the plan for Oncoral. Andreas, do you want to share some thoughts?

Yes. As we have said, we are preparing for this Phase II study, and that will start with a dose finding part of the study. And that is, of course, the stepping stone for the rest. And as always, there is a -- you have to review the outcome of each step before you decide. But we are very happy to have Taiho taking part of the initial steps here, and then we need to see how it goes.

So -- and then there's another question on recent developments in gastric cancer. And that's obviously something we are looking at as well and will incorporate into, you could say, the planning of the clinical study that we will hopefully do with Oncoral. Julie, here's a question for you, whether we have had recent talks with payers or insurance companies on pricing. And also we're mentioning other innovative products. If you can share any comments on that?

Yes. We've done payer research, policymakers, payers, decision-makers also at hospitals, private and public payers continuously. So over the years, we have several pieces of research. And that includes pricing and of course, how they will cover Orviglance. And we do also have research into other innovative diagnostics, as mentioned in this question. We don't think it's right to specifically comment on other products, but a good place to start is to look at diagnostics who also address a small patient population. So for example, diagnostics that have an orphan drug designation and those that have been sort of launched within the last 5, 6, 7 years. And without mentioning product names, there are some within PET imaging and similar areas. So it's mainly to look at diagnostic drugs that address a small patient population. That's sort of the -- you can say, the benchmark also from a payer perspective because it's similar in the way that the budget impact overall is fairly low because it's a small patient population with a high unmet need.

Thanks, Julie. We have a question here related to initiation of coverage recently by ABG, and they issued a research report in April. And the question is that they have significantly smaller market size. I think we're not really able to comment on that. I mean we provide the guidance that we have shared with you also on this presentation. So I think that is what we communicate in terms of market size.

But I think it's fair to add when we look at the way we have worked with our market estimate is that we have combined both literature reviews, epidemiology available online and broadly available data. And then we've combined that with market insights, real-world data and market research for Orviglance. So we are confident that we have worked thoroughly to define our market estimate. And then, of course, other parties have their models.

Which is perfectly normal. And so I think that's -- our perspective is all the analysts that cover us are doing a good job. I don't know if we have any additional questions.

We have a couple of questions from teleconference. So the next question comes from [ Dennis Alff from Private Investor. ]

I have a question about the time line communication in the first half of August there. So it strikes me as quite specific. So I'm wondering, I know that it's in line with previous communication, but should we interpret this as maybe being challenging to submit on time? Is that why you chose to communicate most likely first half of August?

No, I think it's -- I mean, the team has been working extremely hard throughout the process, and we got some feedback from the FDA. And that is doing some additional work that is to be expected. And then we have, you would say, more and more visibility on, you would say, finalization of all the analysis and things that the FDA asked for. And we can see that, that is most likely in the first half of August. And as you say, that's within the guidance we've given. But the guidance we have provided is also that you would say, in principle, it could start next week as a submission. And that is not going to happen. So it's more to provide transparency to everyone that this is the time line that we expect, and we believe is the most likely scenario. So bearing any unforeseen negative surprises, then we are comfortable with that guidance. Did that answer your question?

Okay. I guess a follow-up on that. Just a short follow-up on that. I mean one could envision that you hold out submitting the application to extend your exclusivity time line. Is this something you would consider as well as a strategic choice?

Yes, it's a good point. I mean, we are looking -- our key objective is to maximize the value of Orviglance. And as you're alluding to, the exclusivity window from the orphan designation starts on the day of approval. And we want to make sure that we have a partner with -- that is ready for launch. So that is certainly -- that's an important element. We're focused on making sure that the NDA submission has the highest possible quality, including incorporating everything that we discussed with the FDA. So we have a more -- a smooth review process as possible, highest likelihood of approval and having a partner that is ready for launching.

The next question comes from Johan Unnerus from Redeye.

Some of them have been addressed already. Can you hear me all right?

Yes, we hear you well.

Additional clarification on where you -- yes, where you are in the FDA process. This final step of pre-submission, does it involve sort of questions regarding analysis, compiling [ 16-year ] data. Is the technical manufacturing side completed?

Should I start? The first part regarding the documentation, that is what you always need to do, and that's what we discuss with FDA, how to present the data. And there are quite a lot of documents that needs to first be compiled and also summarized. So that is part of the normal process. And we are also ready for supply or making ourselves ready for the supply to fit the time lines for the approval.

Yes. So you say supply and documentation is on track both -- both for the submission review and for launch?

Yes.

And also congratulations to getting -- securing the attention of FDA. It's, of course, volatile times and level of uncertainty regarding the U.S. administration in general. So that's good news in our view. And what about the partner discussion dynamics? Has they become more intense now in the final stage of the resubmission process or you're active in conferences as well?

Julie, do you want to start?

Yes. I mean you know that we want to succeed with both of these things. And it's a good time because we have both the Phase III data. We have the clarity from the FDA meeting. So we've derisked a lot of this asset. And that, of course, makes partnering discussions very constructive in terms of the risks. And these things take time. So I think the best way to answer your question is we're not bored.

And I suspect that there could be an element of that a potential or an advanced discussion, the conversation partner would want to see sort of that the submission is ticked off before engaging in the final sort of contract signing stage.

Yes, we can't say in detail, but you could say the mechanics are the further we bring the asset -- the more of the value we can, of course, depend on how far we bring it. Yes, the more value we add, the more the partner would, of course, pay in the deal for that.

But we are not -- as we're saying, we're pursuing the best possible deal, and it's really -- we're not having any guidance on timing.

Yes. No. And also these times in this period, there's a lot of considerations on tariffs and potential changes in price dynamics on the U.S. market. I understand you have sourcing relating to the U.S. and also presumably in this space, there is no real international reference price to be considering. So the risks on those issues should be moderate.

Yes. I think it's an important point. As you mentioned, we are in a good place. Our manufacturing is in the U.S. And you would say our cost of goods is not a major component of our product. So I think it's not -- we're probably in the low end of the risk exposure for that compared to other companies. But I think the -- there is a bit of uncertainty. I think we have many times had new U.S. presidents and you would say, focus on health care costs in the U.S. as well as in other countries. So I think we need to see what is really materializes. But I think we're in a good place. U.S. is the first market we're launching in. So we'll see.

Yes. And finally, putting Oncoral to the side, focusing on Orviglance for this year, obviously, submission and signing a partner is the key priority, but you will still be engaged in different ways in Orviglance. What are the sort of support and to do consideration in the later stage of the review process? Will you consider a priority review and perhaps the protocol for these diagnostics will be reviewed and updated as well, for example.

Yes. I can start on the priority review and then Julie can share some thoughts on our role. So we have not decided yet whether to go for priority review. I think that would most likely also be discussed with a potential partner. What we are focusing on is that we want to have the partner ready for the launch and make a successful launch. And the question, Julie, on our role, any thoughts on...

Yes. I think as mentioned, the value of working with the partner is, of course, that they have the commercial infrastructure and capabilities and for most partners, that includes manufacturing and regulatory. So at some point, the synergies are that the insights and relationships are with the partner. But now we are the ones sitting with most of that. So there will be some transition phase where we will be involved. That's what we expect. But of course, the final roles all depend on what type of partner and agreement we may have with them on our own.

Excellent. And congratulations to the progress, and we look forward to -- well, especially August, I suppose.

Yes. Thanks, Johan.

There are no more phone questions at this time. So I hand the conference back to the speakers for any new written questions or closing comments.

Yes. There are a few questions here before we wind up here. There's a question on the cash runway to at least the end of '25 and whether that impacts our, you could say, our priorities and negotiations with partners. Julie, do you have any thoughts?

Yes. I think we are very -- we were really pleased with the outcomes of the warrants exercise that has given us a good flexibility in our cash runway. And you could say it's not uncommon when we look around us that companies are in similar situation. So I think when we look at it from an overall perspective, we should look at the value of Orviglance. We should look at the value of Ascelia, and that's what we're going into in a discussion with the partner, not so much the cash runway because that is what it is in this industry at the moment. So when we're negotiating with our partner, the focus is on the potential of Orviglance and the value of the asset.

And I think just in general, I mean, when you have partnering discussions, the best leverage you can have is to have many potential partners in dialogue at the same time rather than having a financial runway that is sort of whether it's 6 or 12 or 18 months. That's not the main leverage driver. But obviously, as Julie said, we're happy with the outcome of the warrant exercise because that means that gives us a much better financial position compared to if the outcome had been 0. So I think that's really a big positive for the company and shareholders. So with that, thank you for joining us. It's been -- we appreciate all the questions and a long -- yes, we can see there's another question. I'm sorry, that has just come in. Yes. Julie, do we have any -- there's a question on the burn rate after NDA submission, Julie?

Well, the activities after an NDA submission is to prepare for questions from the FDA. And then, of course, we have the ongoing manufacturing preparations. So there are some costs that continue there. And you could calculate it in a way that we talked about the cash we have now plus the warrants. And then we set a run rate to at least the end of this year. So that's the way you can look at it. There are still some costs, but we don't know exactly what that is yet. And that's why we don't want to be more specific. We need to see and be fully prepared for the FDA questions. That's our focus.

Yes. And then I think we -- the final question here, that's regarding the type of partnering. This question mentioned that whether it would be a fit to large radiopharmaceutical companies or you say Lantheus or Bracco as examples. And what are your thoughts on what types of partners are relevant?

It could be different types of partners. The key is that there's a fit to their strategy and also synergies in the typically commercial infrastructure. And that could, of course, be someone else who is talking to radiologists already or someone with a high-value diagnostic drug. So in that sense, radiopharmaceuticals had some synergies. So that's not excluded. There could also be some that are more sort of specialists that have more also treatment drugs or otherwise focused on small vulnerable patient populations. So there are different types of potential partners and these are, of course, included. And there's a question here, if it's a competing product, if it takes market share from them. I think it's important to focus on where Orviglance adds value and what the strategy for Orviglance is. It's a small, well-defined patient population who need liver imaging and also have severely impaired kidney function. And right now, there's not really a consensus or an alternative out there if you -- if gadolinium is not medically advisable. So in that sense, I'm not too worried about competing products from a potential partner.

Orviglance is more like growing the overall market because it provides benefit that is not appropriately addressed by current products.

Yes.

So with that, thank you, everybody, for your interest and all the questions. We'd like to end the conference, and thank you.