Lifecare ASA (LIFE) Q4 FY2025 Earnings Call Transcript & Summary

Good morning, everyone, and thank you for joining Lifecare's Q4 presentation. In Q3 2025, Lifecare consumed significant development costs with the aim to accelerate our product development. In Q4 and to date in 2026, we can conclude on a solid and strong operational results. The development work that we undertook in Q3 2025 has translated into meaningful company value creation. Lifecare's strategic position is significantly improved. We have demonstrated -- we have moved from validation of the sensing principle to demonstrating system-level optimization and product execution. This means that we are no longer proving that the technology works in isolation. We are operating an implantable product that works as expected in real-life biological settings. And that represents an important shift in the risk profile of the company and also in the platform maturity. While our P&L reflects the costs of our development, the operational milestones reflects the values created. And that distinction is important as we move into the next phase of execution. I would like to elaborate this further, walking you through the main highlights of Q4 2025. The first thing is that we have achieved system-level verification. Implants manufactured under our updated protocols were confirmed to track glucose in real-life settings without calibration, smoothening or post processing. Furthermore, we have established manufacturing reproducibility, meaning that we are able to produce implants under our controlled production protocols and demonstrate repeatable implantation-ready devices every time. Third, in our ongoing longevity study, we continue to support the biocompatibility and the signal stability that we read out from real biological conditions. And on a regulatory basis, our foundation has been materially strengthened, including the late news of CE marking of our electronics module, which also enables the veterinary product for clearance in Europe. And finally, we have secured financing to support the near-term operations execution following the January rights issue. As we have transitioned from laboratory validation to system-level execution based on our fully integrated wireless implant that shows strong functionality over time in real-life settings, what we see is consistent and meaningful data and meaningful signal that behaves against benchmarks from reference CGM data as expected. We see no adverse biological reactions and we have no safety concerns related to the implant. And the wireless signal transmission is stable and confirms the overall system integrity. At this stage, we are not claiming and presenting any claims regarding numerical glucose accuracy in the real-life settings. This phase confirms that the product works as designed in real-life biological conditions. The remaining development work and the remaining focus now is on optimization, not feasibility validation. And that is a key distinction. Our ongoing longevity study continues to generate valuable data. Our implants are operating in live tissue as part of a structured study protocol. In the study, we are observing coherent and consistent signal behavior. We observed that our dual cavity system functions simultaneously. We see stable device communication and continued biological compatibility. This provides increasing confidence in the robustness of the platform. We are operating in live tissue over time as expected. On the regulatory side, several important milestones have been achieved. Lifecare's regulatory pathway are significantly strengthened based on our structured disciplined progression toward clinical execution. We have achieved CE marking of our electronics module. It was completed under applicable EU directives a few weeks ago. And this also clears the veterinary product for commercial sales in Europe. However, I want to be clear, the CE mark and the clearance of the veterinary product in Europe does not indicate that we will start sales now. But these achievements significantly strengthen our position and our potential in partnership discussions. Moving to the first-in-human study, we can conclude that the ethics approval is obtained. And we have, throughout the quarter and in 2026, updated our documentation to the Norwegian Medicines Agency, meaning that the regulatory review is still ongoing. However, it is reasonable to expect that we achieve a regulatory approval for the first-in-human study within days rather than within weeks. And the preparation for the first-in-human study is ongoing -- I think you have to go one back. The study is designed to assess safety, tolerability and glucose measurements performance. The clinical infrastructure and principal investigator are in place and operational readiness is aligned. Pending funding, following our ongoing warrant exercise period, we will execute on production of implants as soon as possible following regulatory approval. This is execution progression, not early-stage feasibility work. Before I hand over the stage to the CFO for a financial review, I'd like to briefly zoom out. 2025 represented a structural transition for Lifecare. We have demonstrated reproducible manufacturing, real-life system-level operation, a regulatory momentum as well as strengthened intellectual property. And this represents material risk reductions, not only related to the technology functionality and production preparations, but also to a financial and commercial strategic level. The remaining risks for Lifecare can be summarized to include regulatory execution, manufacturing optimization and securing financing. And that is a very different company profile than 1 year ago. This positions Lifecare for meaningful strategic discussions, and we have experienced increase in strategic interest beyond understanding the technology. That said, I will now hand over to Renete for the financial review.

Thank you, Joacim. So let's move on to the financials with a focus on how the quarter has impacted the P&L and the liquidity. Q4 has been a period of continued high activity. However, a large share of the development expenses were recognized in Q3. Revenue and other income relates to grants and came to NOK 6.1 million in Q4. Compared to 2024, full year revenue is lower, reflecting reduced laboratory service income as we focus on internal development. Employee benefits decreased to NOK 8.3 million in Q4 due to a gradual reduction in headcount. Depreciation and amortization were NOK 2.5 million in Q4, and the increase in 2025 versus 2024 reflects investments in laboratory and office equipment. Other operating expenses were NOK 12.2 million in Q4, down from NOK 54.7 million in Q3. And the elevated cost level in Q3 was driven by intensive product development activities, including engineering work and production processes, which also explains the higher full year cost level. So that means that total operating expenses in Q4 were NOK 22.9 million, leading to an operating loss of NOK 16.9 million. Looking at the cash flow. We started the quarter with NOK 6 million in cash, and cash outflow was primarily driven by R&D activities and working capital movements related to the development activities, resulting in an underlying cash burn of about [ NOK 15 million ]. To ensure funding until completion of the rights issue in late January, we secured a NOK 50 million short-term bridge loan in Q4. So consequently, we ended the quarter with NOK 6 million in cash in line with the opening balance. In January, we completed a rights issue, raising NOK 80 million, securing our cash runway through Q1 2026. And this relatively short runway reflects the repayment of the NOK 50 million bridge loan, which was settled in January. Investors in the rights issue received 3 warrants for every 4 shares across 2 warrant series. These warrants are listed on the Oslo Stock Exchange. And each warrant entitles the holder to subscribe for one new share at a 30% discount to the volume-weighted average share price in the 2 weeks prior to exercise. And the first warrant exercise period started yesterday. The warrants can be traded until the end of this week and exercised until the end of next week. And the exercise price is set at NOK 0.33 per share. The next exercise window will open in the first half of June. Proceeds from these warrants will depend both on the exercise price and the level of execution. So while our short-term financing is secured, we remain dependent on additional capital going forward, including proceeds from the warrant periods. Our capital requirements to complete product development, conduct the clinical trials and obtain the CE mark remains in line with previous guidance. And in addition to expected warrant proceeds, we continue to pursue grant-based funding and other strategic financing opportunities. The pace of development will depend on securing sufficient financing, and any delays could impact our milestones. That said, we remain committed to achieving the milestones required to enter the human market in 2027. That concludes the financial update. I will hand the word back to Joacim.

Thank you, Renete. As mentioned, execution of this full development road map depends on continued access to capital. And the January rights issue secured our near-term operations, while the warrant exercise periods represents potential additional funding. Our focus remains on disciplined and capital-efficient execution. And our priorities are clear and they are actionable. We want to initiate the first-in-human trials upon regulatory approval. We will continue optimization of the implant stability and system robustness. We want to progress toward limited veterinary market launch and, of course, advance the CE documentation to the full CGM system for human use. These are all execution milestones. This is not exploratory activities. Execution remains depending on financing. However, the platform today is fundamentally stronger than 1 year ago. The technology, regulatory and manufacturing progress achieved throughout 2025 has materially strengthened Lifecare's strategic position. We are now executing from a position of validated capability, not from hypothesis, and that changes the direction of the company. I'd like to summarize what Q4 and Lifecare's position as of today truly represents. We have transitioned from validated concept to operational implant system. We have a reproducible in vivo system level functionality that is confirmed, and manufacturing reproducibility is established under controlled protocols. While the regulatory foundation is materially strengthened, the technology and production risk have been materially reduced. This is not incremental progress, this is a structural shift in platform maturity. Our focus now is on execution, regulatory, operational and financial. The remaining work is execution, not validation. That said, I want to thank you all for your attention and, of course, also open for Q&A.

Okay. I can -- maybe I'll just read it up. The first I see here is by which quarter in 2026 will your veterinary project commercialization could bring revenues? And what's the project revenue estimates? And to that question, I can say that we have not estimated any revenue from the veterinary in 2026 and we have projected limited income or revenue from the veterinary product in 2027. So it is no estimations for any quarter in 2026. We expect to have some revenues in 2027. The next question is, what risks does the company still face? I think that's a rather big question. So I'll try to make it short as I already touched upon it in the presentation. But I think it's fair to highlight the really main achievement that we did in the Q4 of 2025, which was showing the ability to reproduce our implants. And based on that progress, we see significant risk reductions on several fields. The first obviously being the fact that we are able to produce the same implant time after time, meaning that we have a credibility and trust in our production and that our produced implants are implantation ready when coming out of the manufacturing line. This also leads into, what I would call, close to an exceptional development in our ongoing study because we're taking these reproducible manufactured implants and deploying them in the study, providing reproducible results based on the fact that the produced implants are the same. This all means that we have significantly taken down the technology risk and we have significantly taken down the production risk. And from our point of view, the remaining risks for Lifecare at the moment is related to the execution -- the commercial execution risk, of course, also related to achieving the regulatory approval that we need as well as the financial risk that we are obviously facing in the middle of a warrant exercise period. So I hope that answered the question of what risks the company still faces. Furthermore, there is a question stating, you previously issued a press release and repeated today that you have secured the reproducibility of the sensor. Could you elaborate on what that actually means? And maybe I should have taken that question first, -- but I believe I just answered that on the last question about the risks that the reproducibility of the sensor is essential in terms of taking down the manufacturing risk and also the product and technology risk. Next question is how we see the potential for acquisition? Thank you. I'm -- I don't think it's appropriate to speculate around potential for acquisition, at least not in depth. However, Lifecare is positioned as a technology company with production capabilities. This indicates that we are positioned for several pathways going forward in terms of partnerships or acquisitions. For Lifecare, it has been important over the last years to ensure that we have production capability in-house because that materially increases the potential value of the company from only being a technology provider to actually being a producer of not the technology, but the product that will be put to market. And I think that it's fair to expect discussions going forward on a strategic level, and these discussions can also include acquisition discussions. I don't have -- but I don't think it's fair to go further into that other than to state that, obviously, we, as a company, are positioned both to be an acquisition candidate, but also to be a company moving forward as a producer with partners that ensure the sales of the product. [Foreign Language] Next question is that you mentioned partnerships a couple of times during the presentation, could you elaborate on your expectations regarding this? And is the company already in dialogue with potential partners? What I can say, as already stated, is that we see an increase in strategic interest for the company beyond understanding the technology. We have a long history of having dialogue with the industry on a broad field. And we are absolutely envisioning some of them as potential partners. We believe that the milestone achievements that we have shown over the last months significantly increases our position strategically, and we expect a continued increase in interest and also substantially, communication with potential partners going forward. The next question is when is the first in-human confirmed? I cannot state that specifically, other than to say that based on the feedback from the Norwegian Medicines Agency on the case handling time, we are expecting the final feedback, which then should be read as the authorization to do first-in-human study within days rather than within weeks. The only risk in that relation would be if NOMA reverts with additional questions. However, we have no indications that they will do so. So we stay on the position that we expect to have a regulatory approval within short time, not counting weeks. The next question is what minimum warrant uptake is required to fund the planned first-in-human trial initiation? And for us, it's a question of execution. The costs related to the first-in-human trial are limited. The production will have some costs, but I'm not in a position where I want to quantify specifically what the first-in-human trial initiation will cost. We have shown today that we have consumed high costs in Q3 2025, and that we, in Q4, are back on a more stable cost level. We expect that cost level to remain until the start of the CE trial that is later in time. Hence, the burn rate per quarter is a clear indication of our needs going forward throughout the first warrant exercise period and to the second warrant exercise period starting in June. And that answered the next question which was, what is the expected quarterly cash burn in 2026 under the current development plan if we assume that first in-human will start in H2 2026. And then under that assumption, the continued quarterly cash burn will be in line with Q4 2025. And also, the next question is that I mentioned in the report, if warrant uptake is materially below expectation, what specific mitigation measures would be implemented? Noted in the report cost reductions, delay of first in-human, et cetera. The reply to that is that the -- our budget and also the total spending outlook that Renete presented in base -- is based on a full throttle progress. What we obviously can do is that we can take down quite a lot of the external costs that we have had related to the manufacturing development and also the production and do the production ourselves in-house at Lifecare. That will probably then affect the time window to some extent, but it is a potential for us to take down the costs quite a lot by moving forward earlier than planned, transit the external work into internal Lifecare work. It seems to be -- that was the last question, unless anybody else is writing new questions right now? I'm going to give it a minute or so to give a last chance. Okay. Then I think it is fair to expect that the questions have been asked. Nevertheless, if you have additional questions, feel free to forward them to Lifecare directly to me or at [email protected]. I thank you all for your interest and participation, and wish you a very good day. Thank you.