Welcome, everybody, to today's event with BioPorto. The topic for today's event is, of course, the right offering with preemptive rights and a update on the FDA submission. Just some practical issues for the audience today.
As always, you're more than welcome to post your questions just below the video, I will forward them to management during the presentation. With me today, I have CEO Tony Pare and CFO Neil Goldman. Let's carry on. Please, gentlemen, you can start.
Thank you, Klaus, thank you for hosting us today. I would like to start with expressing my appreciation to all of our shareholders for their continued support as we progress to get our life-saving test for identifying acute kidney injury to the market globally. As you know, the largest market is in the U.S., and our continued focus is to get the 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 within it. In line with our communications about our capital plans made at both our annual general meeting and our quarterly results update, we recently 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 31, 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 FDA 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 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. If anyone would like to see more information about NGAL, acute kidney injury, please refer to our public filings, the company website, and the YouTube video of our June 1st webcast with HC Andersen Capital.
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 answers to most of their questions, the process dictates that all the answers are supplied at once. Some of these observations required additional laboratory testing, which we are performing with what appear 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 from the FDA by the end of this month, 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.
Some clinicians are not waiting, as they have been able to utilize a laboratory-developed test approach, which is allowable by today's regulations if they undertake a significant validation process, which is not common at most hospitals.
The fact that the FDA granted this test 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'm happy to say that we already have signed agreements representing 28% of the DKK 59.4 million from major shareholders, 100% from 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 offering, all of our shareholders have the opportunity to participate on equal terms, and Neil will review how that works in a bit. The purpose of the offering is to strengthen the company's capital resources and advance implementation of the company's strategic priorities to grow revenues in European and other markets that accept CE mark, continue to support inquiries from the FDA regarding the company's De Novo application, expand total addressable markets for the NGAL Test, and general corporate purposes.
These are very focused priorities. As I said at the start of the webcast, we expect our current cash amount to last into 2024, including past FDA approval of our test. Of course, 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 the 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 DKK 1 per share. The first is to exercise rights. If you are currently a shareholder, you already have been allocated preemptive rights directly into the bank or custodian institution of your BioPorto shares. You simply need to contact your bank by the deadline this week and instruct them to exercise your preemptive rights. Each institution will have their own process and deadline for doing so. Anyone can buy preemptive rights on Nasdaq Copenhagen, whether or not you are currently a BioPorto shareholder.
Once purchased, those rights can also be tendered for BioPorto shares through your bank. The rights are currently trading under the ISIN number listed on the screen, which is also in the launch announcement we issued on May 31st.
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 the 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 email to investor@bioporto.com. I will turn it over to Neil to describe the mechanics of the rights offering process.
Thanks, Tony, and good morning, 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 have already received preemptive subscription rights to new shares.
Specifically, each shareholder has been allocated three preemptive rights for free for every share they own on the record date. Note that shares that have been traded since June first and thereafter have been traded exclusive of preemptive rights.
The subscription period started last Tuesday, June sixth. 17 preemptive rights are required, in addition to a payment of DKK 1, to subscribe for each new share. Please refer to the bottom of this slide for an example of how this works. In this example, a shareholder with 51 shares has been allocated 153 preemptive rights. That corresponds to 3 rights for each share held.
51 times 3 equals 153. The shareholder can then contact their bank now to tender these 153 shares to receive 9 new shares based on payment of DKK 9, corresponding to DKK 1 per share offering price. 153 divided by 17 equals 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 for by existing shareholders.
Together, these will already provide gross proceeds of approximately DKK 16.6 million, or 28% of the targeted raise amount. The subscription period for new shares runs through June 19th, and the rights can be traded on Nasdaq Copenhagen through 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're 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, subscriptions for new shares, and the submission of applications for any remaining shares are all done through your bank, custodian institution, or other financial intermediary.
Finally, 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 be read prior to participating in the offering. These materials describe BioPorto, the offering, including the risks associated with the offering. With that, I'll hand things back to Tony.
Thanks, Neil, now I'm happy to turn the webcast back to Klaus for any questions.
Thanks a lot, Tony and Neil, for thoroughly run through of the share issue and the current status on your FDA application. With that said, we open up questions, there's already a couple of questions coming in here. There's a question about the net proceeds.
Do you have a minimum amount you're looking for to avoid any further capital raises before the FDA approval, Tony? I think you mentioned that during your presentation.
Yeah. We have a minimum amount in mind. We haven't revealed it publicly, but yes, if we are less than our target, it's highly likely that we'll close the round of financing.
Yeah, as Tony said in the prepared remarks, we announced our cash position at the end of the first quarter of DKK 58 million, and that was sufficient to get us, that we believe that was sufficient to get us through the approval. Not knowing when the approval will come is why we wanna be appropriately conservative but balanced with this raise, which is why it's limited to EUR 8 million or the corresponding amount in kroner to make it cost effective.
Thanks a lot, Tony and Neil. You also mentioned that a really good backup, both from yourself, management group and from the board and the largest investors. That's always a good sign. Just briefly on NGAL in Europe, there's been a couple of questions about the CE mark. I know you put it on the agenda earlier this year. Tony, could you just very briefly elaborate on what is a CE mark, and does it go both for the pediatric and adult testing, please?
The CE mark allows us to sell into most countries in the European Union without any additional registrations or proof of efficacy. It is not limited to pediatrics or adults under the current IVD regulations. I will tell you that, there are customers that are utilizing it for both pediatrics and adults throughout Europe.
Thanks a lot. There's a pretty long question here, also about the CE mark. Give me just two quick seconds. About the sales, do you see that, Neil? Let me check this one first. Tony, just see here. It's maybe too long to read anyways.
Well.
Sorry, Tony.
Yeah, I don't see the question, but I can comment on, you know, basically the sales process...
Yes
in Europe. Right now, we primarily work through distributors. The exercise that we have been working on since the beginning of the year is to ensure that, one, we have the right distributors that we believe have the access to the types of customers that we want, as well as the ability to sell clinically.
Two, we are working to ensure that the distributors have all the tools that they need to make a clinical sell, which is what NGAL is. Remember, NGAL is a new test to the market. It doesn't necessarily replace anything that's out there today. You're basically having to educate our distributors and work directly alongside with them to make sales at accounts that aren't familiar with the NGAL value proposition.
Thanks, Tony. I think part of the gist of the question, in addition, if I could summarize for you, Claus, is around what's different now in terms of the approach with Europe versus past attempts, if any, to commercialize in Europe, because it has been available for a number of years in Europe.
Yeah. The key point to that question, if any, right? I think what is different today is really selecting the right distributors and making sure that they have the education and the tools. Typically, when you have a commodity test, one that's been on the market for a while, it could be marketed as a catalog test, right?
People know what it is. They go to the catalog, they order it. That was the approach the company took in the past. The unfortunate thing is not, you know, a whole lot of clinicians knew about NGAL or how to use it, and we're gonna change that.
Yeah, as the viewer asked as well, of course, it's very important with the U.S. market due to size, but it's not like you're not able to sell it because you already show numbers, and you change the strategy, and you show that in your Q1 numbers as well. It's out there, as you mentioned, Tony, you know, it's in the catalog. That's important to emphasize.
Yes.
There's a question here: You hope to expand the addressable market for the NGAL test. What would be examples of this besides the obvious potential adult indications? Other settings you could mention?
Other settings would be. Right now, our test will be approved, we anticipate it will be approved, for pediatrics in the ICU. Obviously, like you said, Klaus, the expansion into adults is one of the areas that we want to execute on.
Adults can be in the ICU, can also be in the emergency room, could also be in outpatient settings. And then, importantly, is to expand the number of instruments that are able to run the test. Through our Research Use Only product, the test is being utilized on, every major, clinical chemistry analyzer that is out there. When you submit to the FDA, you have to validate for a specific instrument and then expand from there.
Our plans include expanding the number of instruments that will be on label, to utilize the test.
... Thanks a lot, Tony. There's a question about your cash position, the viewer here ask, "You must be pretty sure that you have an FDA approval this year. If not, what is your plan B?
Yeah. Well, let me answer that a different way. In our financing, in our raise process, we are not anticipating an FDA approval, you know, anytime soon, right? It could be that the FDA approves in the first half of next year, and so that's part of our, you know, our financing plans, is to make sure that we have enough cash to last at least that long.
If the FDA goes beyond that or basically provides us answers where we have to do additional testing, we will have to assess what type of testing is required in order to get the approval, and then, you know, make cash decisions based on that.
Just to make sure it's absolutely clear, we're not saying that we believe it's gonna be this year, we're not saying it's gonna be next year, because the agency is gonna do what the agency is going to do.
Right.
It's our job to make sure that the company is well positioned to be able to adapt for the variability of outcomes and timings that can happen when you're dealing with a regulator that makes their own decisions around timing.
Thanks, thanks a lot, Neil. That's very important to emphasize. Is there any more questions out there from the, from the audience? Please post the questions, and I will forward them to management. There's one coming up here. Regarding distributors, marketing, and sales.
The shareholders have been around for a very long time, and many are tired when the FDA approval is available. Wouldn't it be smarter to let more experienced players on the market with an established sales structure buy the company? That's a good question, but it could be difficult for you to answer that.
I don't, I don't, I don't control their purse strings. I will, I will tell you from experience that larger players, if they were interested in a product like ours, they would like to see, one, you know, FDA approval, and then, two, they would like to see some level of market adoption, so that, you know, the element of risk is reduced significantly before they make a purchase like that, right?
We're not operating the business. Let me make it very clear, we're not operating the business to be acquired. We're operating the business to basically drive market adoption of the NGAL test.
If there's others that are interested, you know, in making an offer, of course, you know, we're, you know, we're stewards for our shareholders, and we have to listen to anybody that comes to us.
Thanks a lot, Tony. There's a question here coming in. How come the questions raised by FDA have not been disclosed yet?
I mean, I think that's one of those where we need to keep those somewhat close to the vest, because there'd be a lot of speculation around what's required to actually answer those. They're very detailed in nature, and I don't want to let that level of information get out there to be exposed to some of the speculation out there.
I can tell you that, you know, the testing that's required to answer some of these questions, we've done almost everything. We're finalizing the last test required to answer. When I say finalize, we've actually executed the test. Now we're just writing the report.
However, that being said, you know, how the FDA reacts to our responses is really up to the FDA, and they may come back with other tests.
Yeah.
Other questions, I should say.
Yeah, you mentioned several times, Tony, well, there's nothing fishy about the process. The process is actually very straightforward, you just follow that path, actually. This question, it goes very much on the path as well, I'm sorry, as far as I can see, you have paid royalties for the sales to Abbott in your license agreement.
This has to be taken out of the projection. Why is there virtually no interest in this product after 10 years if it really is a blockbuster? Extremely limited sales, no license or distribution agreements involving money to buy BioPorto. You touched upon that a couple of times, but please, Tony, you could maybe elaborate a little on that.
Are you seeing no interest from Abbott at this point, John? I mean, I'll reinforce that what these big players really want to see is market adoption.
Yeah
of the test before interest is, you know, is there.
Good. Goes a question here: How is the profit-sharing agreement with distributors? If you could elaborate a little on that, how it would look like and how should we look at potential future margin levels in that respect? Maybe you could take that.
Yeah. For reasons you can probably imagine, we don't disclose specific arrangements with different distributors, and those would run the usual gamut you would expect with the range of distributor customers that with which you deal with various volumes, that have their own price points and economics that they're able to sustain in the markets in which they operate.
That said, as we've talked consistently with I think the way I put it, with no scale today, with no scale in the business, we're in the 60% margin ranges. Tony and I haven't seen any reason why, at scale, with the ability to leverage the fixed cost to a greater degree over higher volume, we see no reason why this wouldn't be a typical high-value diagnostics business in the 80% margin range.
Thanks a lot for clarifying that question, Neil. Is there any more questions from the audience? Please post your questions. I can mention in relation to today's interview, which we will, of course, post later on today, we will also in H.C. Andersen Capital post the one page on the company, just briefly touch upon, you know, what the company does and, you know, and some valuation and stuff like that.
For the audience just to know, look into the page later on today, and we will post this one page. I don't think there's further questions right now, Tony and Neil. No. There's one coming in here. Let's see. That's a good one: "We trust in you. Thanks for your commitment and great work." That's always nice to hear.
Yes. Thank you for the trust.
Thank you.
Thank you for the trust.
Thanks a lot. By that said, I would like to thanks a lot, to the management, Tony and Neil, to walk us through, today's event, with the share issue. I would like to thank the audience for all the great questions, and, we will be back soon. Everybody, enjoy a sunny day in Copenhagen, at least. With that said, thanks a lot.
All right. Thank you, Klaus.