Now the time is 12:00. It's noon here in Europe, this event with BioPorto is represented by the senior management, CEO Tony Pare, and CFO Neil Goldman. To the audience, thanks a lot for participating in great numbers with such short notice, and that's, of course, due to the capital increase in BioPorto. They sent out a message this morning. As always, you're more than welcome to post your questions just below the picture of Tony, Neil, and me, and I will forward them to management. By that said, I would like to welcome everybody, please, Tony and Neil, carry on.
Thank you, Klaus, for hosting us today. I would like to start out with expressing my appreciation to all of our shareholders for their continued support as we progress to get this life-saving test for identifying acute kidney disease to the market globally. As you know, the largest market is in the U.S. Our continued focus is to get our test FDA cleared. This presentation contains forward-looking statements. This slide contains important disclosures regarding those forward-looking statements and other information regarding this presentation and the securities described in it. In line with our communications about our capital plans made at both our annual general meeting and our quarterly results update, last night, we announced a new preemptive rights offering to raise up to DKK 59.4 million.
During our last quarterly update, we announced a cash position of DKK 58 million, or $8.4 million as of March 31st, 2023. With our cash burn, we expect this amount to last into 2024, including past FDA approval of our test. We do not know the ultimate timing of FDA approval of The NGAL Test , which is for use in pediatrics, but our current plans are not to perform another capital raise before that time. We are undertaking this offering now, since we cannot predict the timing of the approval, and it is important that we have enough cash to sustain operations in the meantime and make some preparations for commercialization post-approval.
During this webcast, I will review the significant clinical impact of acute kidney injury, or AKI, provide an update on our FDA submission, and share an overview of the opportunity for both current shareholders and non-shareholders to participate in the rights offering. Neil will walk through how to exchange rights into BioPorto shares and review the offering schedule. Finally, we will open it up to questions. Taking a step back for a moment, let me remind our shareholders of why we are investing in BioPorto. Acute kidney injury, or AKI, is a debilitating and sometimes deadly disease. AKI occurs when there is a lack of blood flow or good perfusion of the kidney, even temporarily, or the kidney is directly damaged by nephrotoxic drugs and contrast agents.
Initially, there are no symptoms to AKI. If you can detect its onset early enough, you can save the kidney. If detected too late and it does not resolve on its own, the kidney can start to fail, resulting in death or chronic kidney disease and a lifetime of dialysis. The problem is that with today's diagnostics, detection can only really occur in the later stages. Clinicians currently operate in the dark for the first couple of days a patient is in the intensive care unit or ICU. Depending on their training and experience, the clinician will either choose to wait to make any kind of therapy changes or perform prophylactic early intervention measures, such as dialysis, which takes time, resources, and money, and can increase the risk of patient infection or other complications.
If AKI is detected, the kidney can progress through the stages of AKI, acute kidney disease and chronic kidney disease, leading to a lifetime of dialysis or even death. AKI is highly prevalent, expensive, and hard to detect. AKI affects one in four children and 1 in 5 adults that are hospitalized, and it represents up to a $24 billion burden on the U.S. healthcare system alone. There are no early biomarkers of AKI marketed in the U.S. and throughout the world. The standard of practice of using serum creatinine measurements is highly deficient in terms of sensitivity, specificity, and time delay relative to the actual onset and progression of AKI. Relying solely on serum creatinine and urine output, AKI can often be missed, but by the time it is detected, it is too late to meaningfully intervene.
When AKI is detected and treated early, further AKI progression can be halted, allowing the kidney to recover, resulting in minimal or no dialysis and shorter stays in the ICU. With your support, BioPorto is already shifting the paradigm of AKI detection through our proprietary NGAL test, which detects the biomarker NGAL in urine within only two to three hours after initial acute kidney injury. NGAL tests are already marketed in Europe, Korea, and other countries. Unlike serum creatinine, NGAL tests can detect AKI in the absence of any other detectable marker or observable symptom, which can make significant difference in the treatment and outcomes. Our current priority is squarely set on the FDA's ongoing review of our De Novo application. We believe our submission was well supported by a strong body of data from our GUIDANCE clinical trial.
As you know, in January, we received an official request through an Additional Information letter for clarification on 14 specific points. This is very normal, and most De Novo submissions will receive one or more of these requests. Although we have completed the answers to most of the questions, the process dictates that all answers are supplied at once. Some of these observations required additional laboratory testing, which we are performing with what appears to be positive results to date. For this round of questions with the FDA, we do not need to process additional patients. We remain on track to respond to the recent request for additional information by the FDA by the end of this quarter, which is in advance of the July 23rd, 2023 deadline.
As further described on this slide, our strategy is to use the anticipated FDA authorization to establish a beachhead in the U.S. market that is focused on testing pediatric patients. Clinicians are not waiting, as they've been able to utilize a lab-developed test approach, which is allowable by today's regulations if they undertake a significant validation process, and which is not common at most hospitals. The fact that the FDA has granted this test a Breakthrough status for expedited review is a solid indicator that they see a clear unmet need in pediatrics, which will help drive market adoption once approved. This offering reflects our previously announced capital plans. I am happy to say we have already signed agreements representing 28% of the DKK 59.4 million from major shareholders, 100% of the board of directors and members of management.
We have exercised cost control and managed our working capital. This offering will further strengthen our overall capital position. Importantly, as a preemptive rights issue, all of our shareholders have the opportunity to participate on equal terms. Neil will review how that works in a bit. The purpose of this offering is to strengthen the company's capital resources and advance implementation of the company's strategic priorities to grow revenues in Europe and other markets that accept CE mark, continue to support inquiries from the FDA regarding the company's De Novo application, and expand the total addressable market for NGAL Test and general corporate purposes as well. These are very focused priorities. As I said at the start of this webcast, we expect our current cash amount to last into 2024, including past FDA approval of our test.
We do not know the ultimate timing of FDA approval of The NGAL Test, but our current plans are not to perform another capital raise before that time. We are undertaking this offering because we cannot predict the timing of an FDA approval. It is important that we have enough cash to sustain operations in the meantime and make some preparations for commercialization post-approval. There are two ways that investors can participate in the rights offering and purchase BioPorto shares at 1 DKK per share. The first way is to exercise rights. If you are currently a shareholder, then you will be allocated preemptive rights directly into the bank or custodian institution of your BioPorto shares. You simply need to contact your bank and instruct them to exercise your preemptive rights. Each institution will have their own process for doing so.
In addition, anyone can buy preemptive rights on Nasdaq Copenhagen, whether or not you are currently a BioPorto shareholder. Once purchased, those rights will start trading tomorrow, June 1st, under the ISIN number listed on the screen, which is also in the launch announcement we issued last night. The second way to participate in the offering is to subscribe for remaining shares. Remaining shares are new shares, if any, that have not been subscribed for by exercise of preemptive rights during this subscription period. This is open to anyone who is an eligible investor. If you are interested in subscribing for remaining shares, please contact BioPorto Investor Relations via an email to investor@bioporto.com. Now, I will turn it over to Neil to describe the mechanics of the rights offering process.
Hello, everyone. The rights offering is for DKK 59.4 million new shares at a price of DKK 1 per share. In the offering, existing shareholders, as of the end of trading today, May 31st, will receive preemptive subscription rights to new shares. Each shareholder will be allocated three preemptive rights for free, for every share they own. Note that shares traded on June first and thereafter will be traded exclusive of the preemptive rights. The rights will be allocated at the end of the day on this Friday, June 2nd. The subscription period starts next Tuesday, June 6th, because next Monday is a holiday. 17 preemptive rights will be required in addition to the payment of DKK 1 to subscribe for each new share. Please look at the bottom of this slide for an example of how this works.
In this example, a shareholder with 51 current shares will be allocated 153 preemptive rights. That corresponds to three rights for each share that they hold. That is, 51 times 3 is 153. The shareholder can then contact their bank or other financial institution to tender these 153 rights to receive 9 new shares based on payment of DKK 9, corresponding to DKK 1 per share offering price. That is 153 / 17 = 9. As Tony described, current shareholders and other qualified investors, including the entire board and members of management, have already undertaken to exercise preemptive rights and subscribe for remaining shares that might not otherwise be subscribed by existing shareholders. Together, these will already provide gross proceeds of approximately DKK 16.6 million, or 28% of the targeted amount.
The subscription period for new shares runs from June 6th to June 19th. The rights can be traded on Nasdaq Copenhagen from June 1st to June 15th. As Tony described, during the rights trading period, investors can buy more rights through Nasdaq Copenhagen if they wish to subscribe for additional new shares. Alternatively, preemptive rights can be sold if they are not going to be exercised. This must be done before 5:00 P.M. on Monday, June 19th. Any preemptive rights that have not been exercised when the subscription period expires on June 19th will lapse without any compensation. Importantly, the allocation of preemptive rights to current shareholders, trading of those rights, subscription for new shares, and the submission of applications for any remaining shares are all done through your bank, custodian institution, or financial intermediary.
You can learn more about the offering at our website, www.bioporto.com, where you can find the offerings launch announcement, which, together with the company's other announcements and filings with Nasdaq Copenhagen, should all be read prior to participating in the offering. These materials describe BioPorto, the offering, including risks associated with the offering. With that, I'll hand things back to Tony.
Thank you, Neil. I just want to say thank you to all our shareholders for their, continued support. I will turn it to Klaus for any questions.
Thanks a lot, Tony. Thanks a lot, Neil, for good and thoroughly presentation of the company and the subscription issue. With that said, Neil, I have a question for you. There's a lot of questions, some for you as well, Tony, but one question for you, Neil. Early on 2023, you were talking about DKK 75 million. What have changed since you're looking for less now than before?
Thanks, Klaus. That's a good question, and it really reflects the work that we have done between mid-March, when we made that announcement, and now, in terms of what we thought were appropriate requirements to secure the company for the period of time that Tony just.
Are you there?
Neil?
Neil, you just.
Well, to finish the answer for Neil. you know, as management, and the stewards of our, you know, our shareholders' cash-
Shareholders
we're taking a very close look at cost and how we manage those costs and making sure that we are focused on our efforts to get the responses to the FDA, get ready for commercialization in the U.S. and then also market in outside the U.S.. As part of that, we take a very close look as to what is the, you know, the minimum requirements we need from a cash perspective, and that dictates how much we will raise.
Did something happen with my audio or video?
It did.
Okay.
It did, Neil. I apologize.
Sure.
We managed to answer the question. You know.
That's why we're a team.
That's good, Neil. There's a little confusion about, you know, you getting back to FDA, as you promised before Q2 and FDA approval, what I see from the questions here. Tony, could you very briefly just update us on the situation about you answering FDA? Also, when you answer FDA, what is the timeframe until you start to, of course, apply, but then approval?
A little bit about the process. As you remember, we submitted our De Novo application in November of last year. Between November and January, there was a number of questions that went back and forth with the FDA regarding our application, primarily clarification questions. The FDA in January, provided us an Additional Information letter with these 14 observations. Once they provided the letter, the FDA is no longer required to go back and forth with inquiries until we answer all the questions on that letter. We are in the process of answering those questions. We expect by the end of the quarter, we'll have all the information.
The reason why the FDA does that is they knew that we would have to do some additional laboratory testing. We would have to do some additional statistical analysis, and they didn't necessarily want that time to count against the metric that they have. Once we respond, that hold time basically is released, and we can go back and forth with the FDA in terms of any additional questions that they have. When they ultimately approve? I don't know. I wish I knew. You know, we feel very confident about the data.
In fact, the exercise in putting together the Additional Information for the FDA makes us even more confident about the data that we had supplied them in terms of this being a test that will make a difference.
Yeah. As you also mentioned, Tony, just once again, the issue you're carrying out now is, of course, to cover everything until FDA approval. Due to these very uncertain market conditions, it's good businessmanship to carry out the issue now. Actually, you told us 1 year ago, a little more than 1 year ago, that you would carry out that issue in 12 months. This is in due time, you could say. After that, after the approval, that's another story, because then you start to focus on the commercialization of NGAL in U.S., sorry. Just very briefly, NGAL in U.S., is that you are targeting specific clinics and hospitals, could you elaborate a little on that? You did it last time, Tony, what is your strategy once in place?
Yeah. We will target, obviously, the big pediatric hospitals. There are about 300 big, dedicated pediatric hospitals in the U.S. Of course, all 5,000 + hospitals that have ICUs in the U.S. also treat pediatrics, they're also a market for us. As a reminder, the way the FDA or the way our submission defines pediatrics is anybody between three months to under 22 years old. There is a portion of that population that is adult as well. Again, very, very focused initially on those 300 + pediatric hospitals, and then we start to expand into some of the other hospitals that also treat pediatrics as well.
You also mentioned last time when you were online here, that due to this process, so then you start to focus more on Europe, and you already have the CE mark, and now you carry out an issue, you can actually speed up that process. Is that right understood?
Well, we've leaned in very hard into Europe here recently, as well as Korea and some other countries where we are already registered. That being said, we are undergoing an exercise where we evaluate the distributors that we currently have and make sure that they are well equipped in terms of medical education about acute kidney injury, and education about our NGAL assay to actually make those sales. In some countries, we're working directly with customers on investigator-initiated trials that use NGAL. You know, we have started that process. We have a number of people that we have hired on to, you know, basically move those efforts forward.
Thanks a lot. There's a question here about Europe. There's been a conference going on last week, called EuroMedLab. Did you participate there, or did you lobby for new distributors? Can you elaborate a little on that?
Yes, yes. Actually, that's a fantastic conference for doing exactly that, since it is focused on manufacturers and distributors to actually meet with each other. We did participate. We had a number of meetings, both with, you know, the big clinical chemistry assay manufacturers, as well as with potential distributors and current distributors. You know, nothing to announce at this point in time, or nothing I want to announce at this point in time as an outcome of that meeting, but we had some very good conversations.
Thanks a lot, Tony. There's a question about the pricing of diagnostic products. The question goes more like, "pricing of diagnostic products often reflect what the usage of the product means for the payer. In the NGAL case, a shorter ICU stay, would that be a fair description of your NGAL test pricing strategy once approved?
Yeah. The economics of utilizing NGAL come about in two different ways. One is potentially better reimbursement, which is the case if you can identify acute kidney injury, and I'm talking specifically about the U.S. there. In some cases, if there is a very high medical value, in terms of shorter ICU stays and in terms of the ability to keep somebody off of dialysis, you can get better reimbursement that way as well. As well as the hospital just spends less, if the patients are in the ICU as long, or they don't have to dedicate resources to dialysis.
In the U.S. market, it's very much the insurance companies involved as well. If you can show you can save money, normally that's a very good selling point, yeah?
That's exactly right. That will be our focus after we get the FDA approval, is actually performing economic trials to prove the economics behind the test. This is a new test. I mean, you know, let's make no qualms about it. This is new to the insurance companies. It is new to governments that, you know, support the healthcare systems in their specific countries. The, you know, the key for us is gathering the data that supports good reimbursement.
Yeah. I'll add one other thing onto that, Klaus, as it relates to the outcomes of pricing on our financials. That is, as our shareholders know today, this business generates, you know, 60%+ margins. That's with no scale at all. None, right? We've seen nothing to suggest that as we generate scale, that this business can't support 80% + margins.
That's very specific, Neil. Thanks a lot. It would be fair to say, as you experienced in Europe, those hospitals that you carry out the test at in U.S. will be potential clients in the future?
Oh, sure. Both in the U.S. as well as in Europe, right? There are a number of key opinion leaders that are running NGAL tests in Europe. We need to work with them to make sure that, you know, that the test is not one and done, and they're not using that test on their patients after their, you know, their research is done. To make sure that it is adopted in those hospitals. In the U.S., we had over 16 clinical sites that participated in the GUIDANCE study. Some of those sites validated the test as a lab-developed test and are continuing to use The NGAL Test today for use on patients.
Some are waiting for the FDA approval, because that validation process to qualify it as a lab-developed test actually, takes some time, takes some effort and resources. Right now, we have over 30 hospitals in the U.S. that are utilizing this test, clinically with patients.
Thanks a lot, Tony. I don't know if there's further questions about The NGAL Test , the pipeline in general or the share issue. As Neil mentioned, under his presentation, you will be able to find material at the homepage. Neil, I'm right, it's even in Danish?
We have a, an, a very high-level overview summary in Danish as well. That's right.
Yeah. Let's see here.
I can't take credit for doing the translation, though.
That's fair enough, Neil.
The other thing that I could say is that you can always write in Danish to, investor@bioporto.com, and we'll reply in Danish.
Yeah. That's right. Yeah, luckily, you have Tim in place.
Right
to help you out with the Danish language. That's right. That's right.
Klaus, I did see an earlier question, you had responded to the shareholder, but someone had asked about one of our largest shareholders, Arbejdernes Landsbank, and if they're participating. They actually gave us permission to include them in the announcement, and they did the same thing, a little over a year ago, that they are participating in this. In that one instance, it's allowed because they gave us permission to mention that.
Thanks a lot for answering that, Neil. The reason I answered the participant is that normally, you know, we don't talk about specific clients. Thanks a lot for shedding light on that, and hopefully, LBH is satisfied with that. Well, there's which Danish dealers are selected for the NGAL sale? That's an interesting. Denmark is a small market, but maybe you could elaborate on that, either Neil or Tony.
In terms of, distribution.
Yeah
Denmark?
Yeah.
Yeah. We don't have a distributor in Denmark. We're close enough that we could sell directly.
Yeah.
We're right down the road.
Does the same goes for the Nordics? Because that's normally, you know, Nordics is a region for itself. Do you distribute this yourself in the Nordics?
Right now we don't necessarily have a business in the Nordics. I will just say that we're evaluating every country in Europe as to whether, you know, we would be better to distribute directly ourselves or work through a distributor.
Thanks a lot. If there's any further questions, please, let me know, and I will forward them to management. I think that's all. Yeah, that's more or less all. With that said, I would like to, first of all, thanks to Tony and Neil for a good and thorough presentation, as always. Thanks a lot to the audience for all the great questions. We will, as always, be back with BioPorto when we have news, but I can promise you that within a week's time, we will be back with an update on the share issue with management. We will, of course, as always, launch the video with this interview later on today. Hopefully, if you missed something, you're able to look at Neil and Tony again, answering the questions.
Thanks.
Thanks a lot. Enjoy your day.
All right. Thank you, Klaus. Thank you for hosting again.
Thank you, everyone.
Thanks.
Yep.