Lifecare ASA (LIFE) Earnings Call Transcript & Summary

Good afternoon -- no, good morning. And welcome to Lifecare's Q4 presentation for 2024. My name is Joacim Holter. I am the CEO of Lifecare. We will record this meeting. And we have stated here that if you have questions, please feel free to write them in the chat. However, if you rather would like to present your questions orally, please raise your hand and we will allow you into the meeting to ask the question. But, however, first in the Q&A session, not during the presentation, as is. The content of today is operational review, financial review, and some words about the progress and outlook, and then the Q&A at the end. Starting off with the highlights. And before I go into the operational highlights, I want to emphasize as an important company event that we, in the fourth quarter of 2024, listed up on Euronext Oslo Bors. This is, for us, an important happening as a company as part of our preparations towards getting into the commercial phase being profitable, being able to provide the return of investments to the -- to all of the investors. It is important to be listed on the main list of Oslo Bors. And of course, we are happy that we managed to do that in accordance to -- in accordance with our plan. The operational highlights of the quarter is related to our first implant in the longevity study, optimizing the ongoing optimization of our implant designed for manufacturability. The fact that we also in this quarter, in January, has disclosed that we have prepared a new sensor chemistry where we are boosting the glucose sensitivity. And also the fact that we are progressing on our product development agreement with Sanofi. I will come back to these points now. First of all, we have an ongoing optimization and advancing of our design towards manufacturability. Lifecare's organization is built of highly competent and skilled personnel on different -- within different fields of science. And we have been able to bring our technology -- sorry about that, we have been able to bring our technology from the point of R&D and into to advanced product development. However, we saw last summer that we would benefit on assistance from experienced expertise within product development of medical implants and sensors. And we started then to engage with the company named TTP from Cambridge, U.K. Throughout the quarter #4, and also out in this quarter, quarter #1, 2025, we have been working together with TTP on development on the design for manufacturability, meaning that we're constantly optimizing and enhancing both the product and the product tolerances. And through a collaboration where we are facilitating a holistic review of component adjustments and also improved implant. We are very much looking forward to validate the updated implant, and that is due now already in Q1 2025. It's an ongoing process where we are ensuring an enhanced basis for our -- both our longevity study that is ongoing and also for upcoming clinical studies. Another important event is the fact that we, in January, disclosed that we have developed a new generation of our chemistry. And the point here is that this chemistry is fivefold improved in terms of sensitivity. We can state this based on the fact that we have done in-vitro testing of the of the chemistry throughout 2024. And in our test setups in the laboratory, we show a highly increased sensitivity for our glucose sensing, and we also started to show this in our miniaturized sensors, the sensors that we are using in the longevity study. This improvement in glucose sensitivity in the chemistry is expected to lead to, of course, an increase of the sensor sensitivity. However, we have to validate this in-vivo, in clinical trials. But we do expect, based on the current results, that the sensitivity we see in the chemistry will play a interesting role towards an improved mean average relative difference, the MARD being the measure for sensitivity of glucose sensors. This is something that we cannot take out in terms of -- we are not able to measure this in our longevity study. We will have to -- and we have an interest also in waiting to do this until we are conducting the next phase of clinical trials. But at that point, we expect to have a significant improved accuracy of our sensors. Based on the fact that this sensitivity will boost our signal-to-noise ratio, lead to more precise readings and also more efficient processing of data and also reduced manufacturing complexity due to simplified design and software. This -- the chemistry itself has been under our development for some years. And the implementation of the new chemistry is not changing new things in our sensor. So this is all part of our planned and ongoing scale-up towards the commercial phase. It does not imply any delays in any respect to the ongoing continuous improvement of our sensors. Going back a bit to October 2024, it's important in this presentation to highlight the fact that we could conclude that we, from the initial stage of the longevity study in dogs, concluded that we had no unexpected foreign body responses from the implant after 12 weeks implantation. Furthermore, we could also conclude that we had an intact glucose sensitivity when we tested a sensor after taking it out of the first veterinary patient. These confirmations are very important for us going forward in the progress towards both clinical trials and CE marking. And this will support then our continuation of the longevity testing and move us closer to the market. As most of you probably know, we do have a product development agreement with Sanofi, we were able to -- and this is -- the product development agreement consists of work towards miniaturization of our glucose sensor technology. In the fourth quarter, we were able to submit one of the phase-end reports to Sanofi. This triggers some funding from Sanofi. However, the most important thing is that the next phase-end report that is expected to be due for launch after the longevity study could potentially activate the commercial rights from Sanofi. Although, we have to also be clear that we do not have any confirmation on whether they will activate their commercial rights at this stage. Going over to the financial review. Our operating expenses in the quarter were in line with the predictions and expectations of NOK 34 million. Although a bit higher than previous quarter, it was as planned. This is due to higher R&D activities and external expertise. The net cash outflow in the quarter was NOK 14 million, supported by the NOK 16.6 million public retail offering when we went on the Oslo Stock Exchange. OpEx is expected to decrease in the first quarter of 2025, and we are very much looking forward to our upcoming warrant period in early June. And of course, we are hoping for a continued support from our valued shareholders in that phase going forward. Progress of the projects in all is shown here. And as you see in 2025, we have a focus in terms of study on the ongoing longevity study, which is a forerunner to our clinical study that we expect to initiate. This is to build a technical file to claim the CE-mark for Lifecare for the Sencell for the human market. And it's important for me to emphasize that the longevity study and the CE study is connected in terms of the planning. And we have the output from the longevity study is both the fact that we can continue on the CE study, but also the fact that we then can start to enter the veterinary market. However, the driving factor for everything we do in terms of development is related to our human progress. So any disadvantages into the veterinary market would be postponed because our main project is and will continue to be to bring our product into the human market, and it will be a bonus to be able to put the product in the veterinary market within the course of this year as planned and communicated at the latest quarterly report in Q3 2024. To get to this point, we are continuously working on our automated production. It's all interconnected, both the longevity study, the upcoming CE study, the launch in the veterinary market and the automated production. And I am happy to say that we are progressing positively. The spirit in the organization is very good in respect of especially these topics. And we are very much looking forward to executing on this progress in 2025. And that brings me over to the outlook. As mentioned previously, we are advancing optimization of implants so that we can ensure to have consistency in production and drive the progress towards automated manufacturing processes. First steps are taken. We are continuing to work on that and with a very positive progress. We will also conduct in-vivo validation of the new sensor chemistry, so the new sensitive, more sensitive chemistry. And I can share that this is already ongoing. So we have gone from testing this chemistry in a micro cell in-vitro to a miniaturized cell in-vitro, and we are now progressing with the in-vivo testing, the first in-vivo testing. Obviously, the first test of this in-vivo will not give us results that will be conclusive. We have to repeat this. But we will get -- we will receive the first confirmations of the in-vivo validation within not too far into the future. We will, in this respect, continue the study in dogs to confirm the longevity, biocompatibility and data accuracy of our sensor. And we are preparing for the clinical study, so that we can gather data to support the CE-mark for the human market. And in parallel with this, we are preparing for commercialization in the veterinary market and further develop the product for clinical trial use. The report -- complete report from Q4 2024 is available for download as usual, and you will find it at the investor pages at lifecare.no. That concludes my presentation. I want to thank you for your attention, and I'm open for questions, if we have any so far also.

No raising hands. Filip has a question. He would want to present himself.

Please. Yes. Filip.

So I'm interested in the improved sensitivity. When you say you expect the MARD to potentially surpass all the currently marketed CGMs, at what point in time does this statement refer to? Is it at the time of launch of Sencell or later?

I think based on our improvements now, we are -- we believe that we will be able to increase the MARD significantly. And we think it's reason to also believe that we will be in a position to surpass existing continuous glucose monitors in terms of -- based on their MARD values as of today. This is based on the chemistry as it is today, right? So the improvement we already have communicated. And we expect to be able to at least provide data around this within the course of the early clinical -- early stages of the upcoming clinical studies. It is not related to the market launch. We believe that we already now will see an improvement, but it's, of course, difficult for us to put any numbers on that. And it's also difficult to conclude that we are better than our components in the future. But we have a fair reason to believe that the improvement of sensitivity will play a significant role in this respect.

Interesting. And so what is the remaining steps before the improved implant is ready for validation in Q1 2025? Could you just be more specific?

I'm not sure I can be more specific, and it's because of the complexity of what we are doing, right? So we are doing continuous improvements. And I think that maybe the most tangible thing we have done is that we have further miniaturized our total implant with 50%, so that we now are down in a size where we can go from the longevity study, with a rather big implant and to a significantly reduced size of the implant. And we also have a plan to make the implant even a bit smaller within Q2 this year. The sensor itself is definitely on where we want to be on the size of a grain of rice. However, we have electronics, et cetera, that is playing a role. And so that is an ongoing preparation that we are working on. But of course, all of the different pieces in the development, meaning both the encapsulation, the radio communication, the PCB, the communication distance, how we connect the sensor to the implant and how we sterilize it, et cetera, we're all doing this in a design for manufacturability approach. And hence, it is difficult for me to kind of say that this is the next step, because it is a holistic approach where we are adjusting components to optimize both the implant and the output of the implant.

Got it. So one last one, if that's okay.

Sure.

What is -- could you just give us an update on the most recent developments on the veterinary side?

Well, the development on the veterinary side is limited to the fact that we have ongoing longevity studies with our partner at the NMBU, the Veterinary Institute there. We are not ready to give an update and a precise outlook for when we will actually go to the market. I think that it's -- I think I want to kind of elaborate this a bit and say that we can and we could have taken what we have. So our MVP, our minimum viable product could be brought into the market as it is today. And then, of course, it's a strategic question, whether we want to do that based on the totality of the implant, both the production and how it appears in size and how it looks. It's a balance here. We want to ensure that when we go into the market, we have a solid product, both in terms of physical properties and design, how it looks, how it's taken up and how it works. And that is -- it's something about not selling the car if you make it -- if you put a motor into a car made out of wood. So we want to make it as a very, of course, nice and good product before we put it in the market. Functionality-wise, we are definitely where we want to be. And so I'm going to -- I think it was a long answer to a very precise question, Filip, and I apologize for that. But my answer is that we will not be able to provide any specific updates other than the fact that we will go into the veterinary market this year.

Ludvig Svensson?

Yes, Ludvig.

Thank you for a great presentation. So you're saying that OpEx are likely to decrease in Q1. Do you expect this to be a durable decline during 2025? Or are we moving like towards a lower baseline in OpEx? Could you elaborate a little bit on this?

We expect that to be a trend. So we are moving toward a lower baseline in terms of OpEx. We have done significant investment during 2024, and we are going to harvest on that going forward.

Okay. So 2024 cost-wise should be seen as an outlier compared to the other years, so to say?

Yes. That is -- yes, I can confirm that.

And also, maybe you can't answer this, but you're obviously expecting to meet several milestones in 2025. Are you able to provide any more visibility on when this can be achieved? You said that you couldn't comment on the veterinary market, but the automated production and all these things and the start of a clinical trial in humans. Could you say anything about this?

Yes. I think that we -- on purpose, we want to hold a bit back on being very specific on those details because we don't want to go to the market today before we -- and give a road map unless we are absolutely certain that we are able to follow the road map. We have, of course, our internal road map. And we need some additional confirmations. And I hope and expect that we can be more specific on this in the near future and at least coming up to the next quarterly presentation. So yes, unfortunately, I don't want to be more specific on what's going to happen when before I have some more puzzles in the -- some more pieces in the puzzle cleared out.

And we have a question from [ Lene Pedersen ]. When do you expect to enroll additional dogs for your longevity study? And what is the time line for CE marking for device for human use?

Right. So first question, I don't think we are not going to guide on each specific dog. That will be noisy in terms of communication. So we will provide information on our findings on the go and, of course, relevant findings. And I can say that the study in dogs is ongoing. The longevity study is ongoing, and we expect to increase the pace, meaning to enroll further dogs in parallel going forward. And the second question was related to when we expect CE-mark for humans. And I think that we previously as communicated that we hope to be able to be in position for a CE-mark in 2026. I think that is still valid, but I think it's also worth to say that we have been clear on the fact that we don't -- to get to that point in 2026 also includes some luck. So best case is 2026. I think that from a risk consideration, it's probably wise to consider to look more into a base case that would be then the first half of 2027. But I want to emphasize, I'm not bringing any guidance here, and it's not a new guidance. We've been saying that 2026 is best case for CE-mark for human use. So last call for questions. So of course -- no, I don't see any further questions. Then I suggest that those of you who have additional questions or those of you who will come up with additional questions, feel free to reach out. The e-mail address is -- my e-mail address is available on the web page, and I believe the phone number is there as well. So if you can't send an e-mail, you can send me a text, and I will do my best to reply as quick as possible. Thank you so much for taking the time to listening into this quarterly presentation. Look forward to see you in approximately 3 months, and wish you all a great day. Thank you.