Immunovia AB (publ)

Ladies and gentlemen, welcome to the Immunovia Q2 Interim Report 2025 conference call. I am Moira, the Chorus Call Operator. I would like to remind you that all participants will be in listen-only mode and the conference has been recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and 1 on your telephone. For operator assistance, please press star and 0. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Jeff Borcharding, CEO. Please go ahead.

Welcome to the Q2 2025 interim report for Immunovia. Thanks very much for joining us. I am Jeff Borcharding, the CEO of Immunovia, and today I'm also joined by Adam Beckstrom of ProRata. We engaged ProRata earlier this year to manage accounting, financial reporting, and provide CFO advisory services to Immunovia. Adam and his team provide deep expertise, and they have been terrific partners, providing us with excellent services at a much lower cost to the company compared to when we were employing a CFO and accounting team. So we're very pleased to be working with Adam and the ProRata team and excited to have him joining us today. Thank you. Yes. We've spoken often about Immunovia's mission. This mission drives the work that we do every day to increase pancreatic cancer survival through early detection in high-risk individuals. Today's call is especially important as we think about this mission because we've never been closer to achieving that mission. We are taking a significant step forward as we progress through this journey to making an impact in pancreatic cancer. The launch of the Pancreature Test next week is a key milestone in this journey, and we're excited to share information about that launch with you today. Before we do that, we'll hit key highlights from the second quarter of 2025 and review our Q2 financial results. We'll also discuss the shareholder rights issue that we announced late yesterday, why we are doing that rights issue and how we will use the funds from that investment. Finally, we'll spend most of our time discussing the Pancreasure test launch and what lies ahead for Immunovia and for our test. But first, as we look back and reflect on the second quarter, One of the critical things that happened in this quarter was essentially the scientific community taking notice of the clinical data and the work that we've been doing on the pancreas share test and really celebrating and embracing that work and highlighting that work for physicians that are in this space. In the second quarter, we had the Digestive Disease Week meeting. This is the largest gastroenterology conference in the world. At that conference, one of the primary investigators from our clarity study presented the results from that study to the participants at that meeting. We were very excited that that presentation was highlighted as best of DDW, which recognizes the most important presentations from the meeting based on the clinical impact and the importance of those studies as well as the scientific rigor. We think that's an incredible endorsement of the quality of the science that backs the pancreas sure test. Similarly, at a meeting of the Academy of Diagnostics and Laboratory Medicine, we were very pleased that our analytical validation study was selected to receive a prestigious award called the Distinguished Abstract Award. Only about 2% of the abstracts that are submitted to the conference are selected for this award. And we really think that it highlights the fact that when we did the analytical validation of the pancreas sure test, when we were looking at the precision of the test, how robust the test is, how stable the test is, We got excellent results, and those results were recognized with this prestigious award. In addition to moving things forward on the science front and sharing and disseminating data about our studies, we also made important progress toward securing payer reimbursement in the second quarter. As I've shared previously, the road to reimbursement is an extensive process, and there are a number of steps along the way. To secure payment for a diagnostic test, there are three overall key steps, securing a code, securing a cost, and securing coverage. A code essentially means that you are assigned a numeric code for the test that enables you to seek payment from payers. When we talk about cost, what we really mean is what's the price of the test that will be reimbursed by Medicare, which is the government payer for people over 65 in the U.S., as well as by private insurers in the U.S.? And then finally, the third component is coverage. This is the place where those insurance companies and government payers make the determination that the test that we have is medically necessary, that it's an important test that should be offered to patients, and that the government or that payer is willing to reimburse us for the test. So each of these needs to come together in order for us to get reimbursement. So what happened in the second quarter? Well, importantly, we were able to secure a code from the American Medical Association. This code will become effective October 1st, and it means that after that we will be able to submit claims to insurance companies. Again, that's only a first step, but it's an important step. For the cost, we have made a proposal to Medicare for what the cost of our test should be. What should that reimbursement rate be? that appears on a national fee schedule called the clinical lab fee schedule. The price that's reflected there is really important for two reasons. First, that's the price that's used by Medicare to reimburse tests. The second is that that number largely becomes a reference price that other payers use in setting the price that they'll reimburse the Pancreasure test for. So we've made a recommendation to Medicare. What we recommended to Medicare is that the test of the Pancreasure test should mirror the price that they previously had awarded for the Imre Pancandee test, our first-generation test. That would put the price of the test at $897. a process by which others can recommend a price for the test as well. There is another group, the committee, that recommended a price of $760. So we're now in the process of working with Medicare to determine which of those two recommendations will be adopted. Regardless, we feel good about the outcome of that process, and we feel like we'll have an attractive price for Pancreasure. Finally, on the coverage side, we have designed two clinical studies that we'll be conducting in the fourth quarter of this year as well as in early 2026 to demonstrate clinical utility. Clinical utility basically means that the test has value for physicians, they use it in their decision making, and it has value for patients because it helps them have better outcomes. So overall, a quarter of strong progress on the reimbursement front. With that, let me hand it over to Adam to review our Q2 financial results.

Thank you, Jeff. So a little bit, as Jeff said in the beginning, one important word has been that we need to find more cost-efficient way to operate our operation and one thing that we have been looking into new solution in IT and other overhead expenses that we have been able to reduce in the last period. As you can see our operating expenses during the second quarter were around 20 million SEK which is 17% lower compared to the same period last year. Another thing that has been very important now when we look into the into the different kind of cost saving is that we still want to accelerate the work with the commercialization, which means that we need to focus and allocate our expenses on the right things. When we're looking at our cash balance in the end of the second quarter, we have roughly 29 million SEK, which is a little bit better than we had predicted from the beginning. Our cash burn had been lower during the second quarter, by the cash burn has been around 6 million per month, and our projections was 8 to 10 million. These 8 to 10 million that we have in projections are still in line and is what we are expecting to have until we reach the commercial phase.

Thanks, Adam. Following on that discussion of our cash balance and our burn, Clearly, we knew that we needed to raise capital in order to fund the next phase of the Immunovia launch of Pancreasure, as well as the clinical studies that we will use to seek reimbursement. We were pleased to be able to put together a rights issue that will have a value of 100 million SEC if fully subscribed. We were able to secure guarantees of 80%, so 80 million SEC. We have strong insider participation. I think it's important to share that every member of the Immunovia Board will participate in the rights issue. I will also participate in the rights issue as well as I have done in the past. Looking at the timeline, a couple of key dates. that will be important to the rights issue. We do have an extraordinary general meeting of shareholders on September 29th, where we will seek approval for the rights issue. And then the subscription period in which investors can exercise their opportunity to participate in the issue will take place between 7 and 21 of October. As we go into the launch, we'll share a little bit more about the use of funds, but I think most importantly, as I mentioned, there are two key things that we will be using the funding for. The first is to commercialize the pancreas share test, and we'll talk about our plans there and how we will do that. The second are clinical studies that will support reimbursement. These are critical in order for us to secure reimbursement, and generate the revenue that fully reflects the value of the Pancreasure test. So let's talk about the launch of Pancreasure. We're incredibly excited that we are literally just days away from the launch of the test next Tuesday, September 2nd. I am very excited and energized by the response that we've received. from experts in the field who lead high-risk surveillance centers. They're excited about the test. They are excited about its potential to help their patients. You can see one of those individuals here. Bryson Katona is a professor at the University of Pennsylvania School of Medicine. He is an expert in inherited gastrointestinal cancers, and he runs a large surveillance program for people who are at high risk. What he shared with us is the launch of Pancreasure is an important advance in pancreatic cancer surveillance. We have long recognized the need for blood-based tests to accurately detect early-stage pancreatic cancer in high-risk individuals, and we're excited to offer this test in our programs. Thinking about the strategy, it's very important that we are intentional about how we launch the Pancreas SURE test. Here are four key elements of that strategy. The first is the idea of starting at the top. We want to build advocacy and use among the key opinion leaders and the leading high-risk surveillance centers in the country. That advocacy will be critical for getting other gastroenterologists on board with using the test because they see the experts in the field doing so. Second, and this is critically important, we want to make sure that we tie our investment, tie the cash that we're spending to revenue. So we want to execute a very targeted, low-cost launch initially where we leverage a lot of our current resources and our current strengths From there, we can increase investment over time, but we want to sync that increased investment with reimbursement. We don't want to generate a large number of tests before we have that reimbursement, because the average revenue per test will put us in a position where our finances wouldn't be sustainable. So we want to be really disciplined. We want to be very careful with the the cash that has been entrusted to us by shareholders. As we think about this launch, one of the really important things is that we position ourselves for the strategic partner that we want to develop a relationship with. So it's important that we show commercial response that's very positive and that we're building towards reimbursement and revenue. That partner will be critical for helping us drive future volume, and so it's important that we take the right steps early in the launch in order to be an attractive partner. Finally, I can't say enough good things about what the Immunovia team has done to ensure that as we launch this test and move forward, we can do so in a way that is very lean, very efficient, and keeps our costs as low as possible. We've had a focus on operational efficiency that's been very beneficial. We are automating a large number of tasks. We're focusing on how we build things in a scalable way so that as volume increases, we're able to handle that increased volume without increasing staffing. And one of the other things that we want to do is limit our fixed expenses. In the early stages of launch, it's important that we don't take on a lot of expenses before we have that revenue coming into the company. A little bit more detail about our commercial strategy and the phases that we will go through as we launch the test. The launch will proceed in three phases through the rest of 2025 into 2026 and 2027. As we progress, we will expand the physicians that we target. So we will initially begin very targeted in what we're calling the targeted advocacy phase. From there, we will expand the number of physician targets in the volume building phase and even more expand that group as part of the revenue growth phase as we enter 2027. Our initial targets during the targeted advocacy phase which will run through mid-2026, are key opinion leaders, as well as the high-risk surveillance centers across the United States. As we've shared previously, there are about 200 of these centers, and they offer a rich target for us to sell pancreas sure. That initial selling effort so far has been done by the management team at Immunovia. We have not hired any sales reps at this time to conduct the sales efforts. We've been doing that with the existing team and I meeting with potential customers. As we get to the end of this year and at the beginning of 26, we will build a small Immunovia sales team. The exact size is to be determined, but I suspect it will likely be five reps or fewer. As we move into mid-2026, that's where the pace starts to accelerate and we've shown that we've got advocacy from the experts, that's when it'll be really a critical time to expand the number of physician targets. We'll look at gastroenterology groups, pancreatologists, endoscopists. And in order to do that, that's when it'll be important for us to bring in a strategic partner who has an existing sales team in gastroenterology. So what we'll do is look to ramp up volume as we start to approach reimbursement and put ourselves in a position where we can really drive revenue in 2027. One of the questions that we often get is, what is your forecast and how are you measuring success? We will measure success differently as we go through these three phases. During the initial targeted advocacy phase, the primary metric of success is how many high-risk surveillance centers are ordering the Pancreasure test. That's the best measure of are we achieving our objective of building advocacy during that phase. In mid-2026, our focus will shift, and we'll then have a key metric that's focused on Pancreasure test volume. Finally, as we transition into 2027, our focus will be on Pancreasure revenue. that's when the combination of higher volumes and reimbursement will really drive substantial revenue. Obviously, we will have revenue before that, but 2027 is really when the revenue will ramp up significantly. I mentioned that we are focused on advocates and experts in this space. You see here a quote from Urquhart Borizonski, who is the medical director at Honor Health in Arizona. Urquhart leads the oncology research division, which is one of the most prestigious organizations in the U.S. for doing pancreatic cancer research. He has a large high-risk surveillance program, and he noted to us that people often ask if there's a blood test to detect the disease, and he characterized Pancreature as a big step in that direction. You can see here that he's excited about being able to offer a convenient blood test to high-risk individuals in their program. So far, there are seven top pancreatic centers in the United States who are in a position to immediately implement the Pancreasure test at launch. They've been trained. They have all of the setup. They have kits on hand that they can use to collect blood and send that back to us. We will have seven at launch. You see a few of them here. We are excited about the pipeline of additional centers that we have, and we will be sharing news about those in the coming weeks. One of the things that I will mention here and also mention again at the end is that we'll share a lot of information on LinkedIn. Some of this we will share on a daily and weekly basis just to keep everyone up to date on the how we're progressing, which high-risk surveillance centers are coming on as customers. And so I would encourage you to follow Immunovia and to follow me, Jeff Borcharding, on LinkedIn as well. Maybe just a final comment from one of our initial customers. This is Dr. Rosario Lagresti, who is the Chief of Gastroenterology at Hackensack Medical Center. And he highlights the fact that pancreatic cancer is so lethal because it's usually diagnosed too late. We need more ways to detect pancreatic cancer early, especially in people who are at high risk. And the Pancreasure test has proven to accurately detect stage 1 and 2 disease, making it an important addition to our toolkit. I should note that Dr. Lagresti used the M-ray pancandide test previously, our first-generation test. and he was excited to hear that we were bringing this one back. We have kept in contact with him as we've been developing the Pancreasure test. I met with him earlier this week, and he's thrilled to be able to offer it to his patients. I mentioned that we'll be sharing additional information about the launch and physicians who are starting to use the Pancreasure test. Here you see the addresses for Immunovia itself as well as my LinkedIn address. If it's easier, you can also just search Immunovia or search Jeff Borcharding on LinkedIn. We'll come up and then you can follow us or you can connect with me. Again, we'd love to be able to share information with you as we go through the next few weeks. As we think about the launch, there is tremendous opportunity Beyond the seven centers that we have already planning to use the test and starting to use the test, there is another group that is at least that big that we expect to bring on board very shortly after the launch. So a lot of news to come on the adoption of the Pancreasure test, but we're excited that we have already seven centers, and these are top programs across the country that will be using the Pancreasure test. With that, I'm excited to hand it over to all of you. We would love to answer any questions that you have about our Q2 results, the rights issue that we announced, or the Pancreasure launch.

We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on their telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode while asking a question. Anyone who has a question may press star and one at this time. First question comes from Herman Kuntzer from CarSquare. Please go ahead.

Yes. Hi, Jeff. Thank you for the great presentation. So a quick question regarding the addressable market and inclusion of patients presenting with pancreatic cysts. Could you perhaps expand a bit more about how you view that market and the inclusion of pancreatic cyst patients and how many of those are in screening programs today, et cetera?

Sure. So pancreatic cysts is an important challenge in the clinical community. And from a market size standpoint, we suspect there's limited data on pancreatic cysts. But from conversations we have with physicians in the space, Generally speaking, the pancreatic cyst surveillance programs are generally about the same size as the programs that are following the people who are at risk of pancreatic cancer because they have family history or genetic mutation. So it is a significant market. It's a market that is very challenging because often these pancreatic cysts are hard to determine when they become cancerous just using imaging. So, we think there's an opportunity there. In terms of data, about 30% of the people who have been in our studies with familial and hereditary risk also have pancreatic cysts. In addition, with the VERIFY study, we included a large number of patients who had pancreatic cancer developed from pancreatic cysts, as well as control subjects who just had cysts. We're building our evidence there. We have two NIH-funded studies in pancreatic cysts. I suspect that we will see some use in cysts after launch, and the use will increase as we generate more data.

Okay, thank you. And I remember that you also have a study underway with the University of Leiden, or Leiden University in the Netherlands. I remember that you

said back then that the timeline for the study was was not available yet do you have any updates to to that study i don't other than um you know we we have uh processed the tests internally and shared that data back with leiden the study the way that it's being conducted is that we run the tests in our lab and then provide data to leiden they'll be doing all of the analysis of that data. So the timeline is really driven by them. And so, you know, I suspect that we'll see something later on this year or early in 2026.

Okay, great. And on the cash side, you stated that multi-burn is expected to go back up as you launch the test now in September. Are there any one-off costs or anything other on that side that you are aware of that could come up that is not included in the monthly burn of $8 to $10 million that you expect?

No, I think that if there are one-off costs, you know, we generally – our goal is to plan those and make sure that we can absorb them from within that $8 to $10 million per month.

Okay, thank you. And then finally, so in a review that was made in critical reviews in oncology and hematology, there was some talk about liquid biopsies targeting circulating biomarkers for pancreatic cancer. Is this something that you hear discussions about when you consult with different pancreatic cysts or pancreatic cancer experts? Is this something that you envision could be a point of competition in the future, perhaps?

Yes, so we hear a lot of discussion about it. You know, certainly there is a lot of technical interest in that approach. So maybe just a little bit of background for people. The pancreasure test is a protein-based test. So we're looking for proteins that change when pancreatic cancer is present. Many of our other competitors are looking for circulating tumor DNA. These are little pieces of the tumor that DNA from the tumor itself that break off from the tumor in the pancreas and then start to circulate in the blood. What we have seen, and it's happened in multiple studies now, is that looking for circulating tumor DNA is effective at finding late stage pancreatic cancers, but it has not shown to be effective and accurate for finding early stage cancers. So there are multiple studies out there where the sensitivity or the ability to detect stage 1 and 2 pancreatic cancers for those approaches is somewhere around 60%. For us, it's 78% or 77% in the two studies that we've done. So we think there's a significant benefit in terms of sensitivity to the technology that we're using. So we see that as competition, but we really feel like the increased sensitivity of our test puts us in a great position.

Okay, thank you very much.

Thanks, Herman.

For any further questions, please press star and 1 on your telephone, star and 1. Once again, to ask a question, it's star 1.

We do have some questions that have come in on the chat. One of them is, do you think a diagnostic company is ready to purchase Immunovia? I don't. What we see when we talk with potential partners is that those partners are interested in companies that are at the stage where they have clarity around reimbursement and they are generating revenue. So in order to be valuable and attractive to those companies, we want to get further down the process It's also important, I think, from a shareholder value standpoint, that if we were to sell the company, that we do so at the right time. You know, we don't want to sell too early and sell the company before the value fully reflects the potential and the value of the pancreas share test. So, I don't see that as a near-term likelihood. A question here, I think this is important, is the 80 million SEC guaranteed enough to bring Immunovia into profit, or should we expect more rights issues in the future? So the $80 million that's guaranteed out of the $100 million SAC, as we look at the capital that we expect to raise from this rights issue, it will take us well into 2026. It will help us through this initial phase of the commercial launch, the targeted advocacy phase. It will also fund some of the studies that we need to do in order to secure reimbursement and to apply for that reimbursement next year. In terms of future financing, I think it's difficult at this point to predict. Certainly, one of the things that we are focused on is looking at ways to fund the company that are not dilutive to current shareholders. Obviously, we know that a rights issue is very dilutive, and so our goal is to avoid that either through strategic investments or securing grants and other funding. Obviously, we can't at this point say how likely that is, but that is certainly our focus. And this capital raise through the rights issue gives us quite a bit of time to work through those opportunities. Let's see. Some of the other questions here. How large is the high-risk population in your initial markets? So the population of people in the U.S. who have family history or genetic mutation and really are in that initial phase of learning about that, that's really a group of about 600,000 people in the U.S., we think that that pancreatic cyst population could be as large as that, although the data is not quite as common there. So those are the places we're focusing initially, with other opportunities after that as well. A question here, the plan was to team up with an established partner this quarter. Why has that not happened? I think we have shared along the way that Finding a partner and coming to an agreement is something that's very difficult to predict the timing of. And in addition to that, I would say that we want to make sure that we partner at the right time. If we partner too early, we go into that negotiation with very little leverage. The more success that we show with the Pancreasure test, the closer we are to reimbursement, the more revenue we are generating, the more powerful our negotiating position and the more people who will be interested in bidding for the partnership that we're talking about. So we're in a position where not having a strategic partner doesn't get in the way of us executing the launch. As I shared, this initial phase is very targeted and focuses on the high-risk surveillance programs and the top experts in the field. We can do that very cost-effectively ourselves. It'll increase the value and allow us to get a better deal from the strategic partner. The question here about what are your expectations on price from Medicare? how will it relate to the patient pay price of $1,000 that you've announced? I think the key is that, as I shared earlier, we're in the process of determining that rate. we expect that that rate will be somewhere between around $900 and potentially $760, which is the recommendation from one of the committees. So we think those are the two ends of the range, and so we should have clarity on that over the next probably two to three months. Really good question here. How many tests are you expecting to sell within 12 months? You know, I think for us, as I mentioned earlier, the key metric between now and the end of 2025 and even into 2026 is what is the number of high-risk surveillance programs that we expect to be using the test? So, I mentioned that we have seven that are onboard at launch. We have a similarly sized group that we expect to come onboard. very shortly after launch. So this year, we are aiming to have at least 15 high-risk surveillance centers using the test with the goal of getting even 20. So that's our focus. That's the key metric that we will be looking at and reporting on. We'll shift more to a focus on volume in 2026. A question here, a very fair question. Please tell me why I should participate in the rights issue. Obviously, the decision to participate in the rights issue is a very personal, individual one. I will tell you why I chose to participate, you know, and what argument and conversation I had with my wife about investing our money in the company. What I believe is that we are at an important point change point for the company, where the company's value is set to increase in a meaningful way because of the fact that we now have a test in market. We are in a position where we are commercializing that test. And as we look forward, I see good opportunities for us to not only drive advocacy among key opinion leaders, I see opportunities for us to drive volume later in 2026 and I'm optimistic about our prospects for reimbursement because of the quality of the science that we've done. The last thing that I would say, and this has really been true since the beginning of this process of developing Pancreasure, is the fact that there is absolutely a need for this test in the market, and we have developed a test that is accurate and that meets the need for much more convenient, much more cost-effective tests. monitoring of pancreatic cancer. Question here, how much of the total sales or revenue will come from reimbursement and how much will be paid for in another way? What's that percentage look like? It will shift over time. So in 2025, we will be fully patient pay, meaning that All of the revenue that we generate from patients will be generated through what they pay for the test. The cost of the test is $995 for patients. If they pay within 15 days, they can get a prompt pay discount that makes the price $750. In addition, people who have financial need will be eligible for a lower price. that price could be $0, $100, or $200. So in 2025, the vast majority, if not all of the revenue, will come from patients. In 2026, we expect that most of the revenue will continue to come from patients, but especially towards the latter part of the year, we expect to see more money coming from insurance companies. As we get into 2027 and we expand reimbursement, it will further shift to the point where it's very possible that in 2027, most of the revenue is coming from insurance companies rather than from people themselves. There's a point here about, you know, that the company has forced shareholders to participate in a series of rights issues to avoid dilution. Was this the last one? You know, as I mentioned earlier, certainly my hope is that it is. I cannot guarantee that, but I can promise you that I'm very aware of the dilution and the pain that that dilution causes our shareholders and want to reassure you that we are doing everything we can to make sure that we generate funds that are not diluted so that we can avoid that rights issue. So, again, it's impossible to guarantee that, but that is certainly my intention. Question here, how often do you expect each patient to take the test? I would say generally speaking, we expect patients to take the test once a year. There will be some cases where you have an especially high-risk person, and that individual will likely get the test two times per year. There may also be high-risk surveillance centers that choose to alternate the immunovia test with imaging on an annual basis. So in that case, it would be every other year. But I would say in the majority of cases, most frequently it will be annually. And then a question here, how do you or can you explain the process of how buying Pancreasure will work? This is a really good question because the process might not be totally obvious. The way that it works is that a physician will decide that they want to order a Pancreasure test for one of their patients. To do that, they go into our online portal. and very quickly within a matter of probably less than a minute or two they're able to place that order at that point then the patient's blood needs to be drawn sometimes that blood draw will happen at the site itself at the same time in other cases that blood draw will happen at a third-party lab where the patient goes and has their blood drawn once that blood is drawn It's sent to our lab in North Carolina where we will process that test. We then provide results through the original online portal where the physician also placed the order originally. So at that point, once that process is done, then we bill. Initially, we'll bill the patient. Over time, as we start to implement billing of insurance companies, we'll send bills to both the patient and the insurance company. When do you think is the earliest you can submit the application for reimbursement? I think the first half of 2026 is when we plan to apply for reimbursement. You know, those timelines depend a little bit on our clinical program, but that's the timeline that we've mapped out. And I think those are all the questions. I really appreciate the engagement, really appreciate the questions, certainly know that there are some tough questions out there, and hopefully you feel like the company has been transparent and I've been transparent about where we are and what the opportunities are that lie ahead, and also the challenges that we face. The reality is that it's not easy to bring a test like Pancreasure to market and to have that be a commercial success. We feel very, very proud of the fact that we were able to develop the Pancreasure test in just over two years and bring it to market, and we look to have similar success commercially to the success that we've had in the development phase. So thank you very much for joining us today. Thank you for your support of Immunovia, and we look forward to the days ahead. Take care. Thank you.

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