Neola Medical AB (publ) (NEOLA) Q4 FY2025 Earnings Call Transcript & Summary

We welcome viewers to this live broadcast where Neola Medical has published their fourth and final report for the fiscal year of 2025. And joining us here in the digital studio is CEO, Hanna Sjostrom; as well as CFO, David Folkesson. And we'll turn to Hanna, of course. Welcome, Hanna.

Thank you so much.

You will give us a presentation. Afterwards, I'll return to ask some questions. [Operator Instructions]. So Hanna, go ahead.

Well, a very warm welcome to everyone joining today. So today, we will present Neola Medical's year-end Q4 report for 2025 and are summarizing a year marked by key milestones as we, this year, really entered the clinical phase, strengthened the organization and continue to build on our strategically important assets. And presenting here today is myself, Hanna Sjostrom, I'm CEO of Neola Medical since 2019; and CFO, David Folkesson. First, I will present the company, the market and significant events during the full year of 2025 and also, of course, during the quarter. And thereafter, David Folkesson will walk you through the numbers and the financial summary. Before we begin, please do note that today's presentation may include forward-looking statements. Actual results may differ due to risks and uncertainties, including market conditions, regulatory processes and execution of our strategies. Neola Medical is a deep tech company developing a Class II medical device, Neola, Neonatal Lung Analyzer. And it's designed for noninvasive and continuous lung monitoring of preterm born babies. The company was founded in 2016, and we have our headquarters in Lund, where I'm presenting today. The technology behind Neola is based on our patented GASMAS technology, that is Gas in Scattering Media Absorption Spectroscopy, developed at Lund University and further advanced by Neola Medical. Today, we're in the clinical phase with our medical device aiming for market authorization in the U.S. And our mission is to advance neonatal care by giving preterm born babies a safer start in life. With Neola, we aim to support healthcare professionals with real-time respiratory insights, enabling instant detection of severe lung complications, providing earlier intervention, proactive care and ultimately, better outcomes for these patients with the potential to reduce morbidity and improve long-term quality of life. Our revenue model extends beyond the primary sales of Neola main unit and also includes the sales of disposable probes that are changed daily on the baby as well as service agreements. And we expect those disposables to really be a key driver of our revenue and margins. We currently hold 8 patent families covering medical methods, and device and disposables, ensuring protection of our core innovation, but also enabling scalability to other patient groups. As you've seen in the Q4 report, if you had a chance to read it already, we continue to strengthen our patent portfolio, highlighting 5 new patent grants in this quarter. We are a Stanford Impact1 company as Neola has been recognized as one of the world's most promising innovations with the potential to really transform neonatal intensive care from day 1 in clinical use. And this prestigious acknowledgment really underscores the groundbreaking nature of our medical device. As being part of this very exclusive network, we gain unparalleled access to Silicon Valley experts, FDA adviser, regulatory specialists and commercialization support for our market launch in the U.S., alongside also collaboration opportunities with the world's leading neonatology doctors. The Stanford Impact1 program is led by Professor Neonatology, Janene Fuerch, one of the neonatologists in the U.S. and key opinion leaders currently giving Neola Medical clinical support. And many of the neonatologists and clinicians that we meet emphasize on the insufficient current monitoring methods in today's neonatal care. So doctors rely mainly on manual observation, chest x-ray, blood gas samples or pulse oximetry, tools that are very slow, provide only snapshots of the lung status or are invasive or potentially harmful. So in critical cases, results from current monitoring methods may take up to 2 hours, while a baby may already be deteriorating. So with Neola, our goal is to provide continuous real-time monitoring to be very safe for the fragile skin of the neonate with that instant detection of large lung complications. And with Neola, we're not only addressing the monitoring limitation in today's standard of care, but also a growing clinical need as more babies are born preterm. So today, 1 out of 10 babies are born preterm and often depend on intensive care for survival and for their long-term outcomes. Many of these babies also have underdeveloped lungs that can quickly advance into life-threatening complications and lasting disabilities. And preterm birth remains the leading cause of death for babies under the age of 5 after pneumonia with that respiratory failure being the #1 primary driver of death. So in neonatal care, every minute counts. And due to the lungs being highly underdeveloped, lung-related conditions in preterm born babies can lead to serious complications if they're not detected very early. And standard of care do not provide a comprehensive picture of baby lung status. And this limitation really increases the delayed detection of conditions such as the lung collapse, which carries a mortality rate of almost 22% in newborns. So finding a lung collapse early is of utmost importance. And as you can see here from the picture, at week 24 of the baby gestational development, they only have a 50% chance to survive even with neonatal intensive care. And since the development of medical device for children is on average 5 years to 10 years behind device for adults, there is a clear need for a new medical device in the neonatal intensive care. It's driven by a number of factors. We have a growing number of patients. There is an increase in preterm birth worldwide, leading to more children developing RDS, respiratory distress syndrome and other lung complications that need lung function monitoring continuously. We also have the opportunity to generate high margins globally, especially in the U.S. where the pricing landscape remains favorable. And moreover, there is a rising awareness of the importance of newborn disease prevention, leading to an increase in demand for neonatal intensive care, respiratory products and services. And this is something we see specifically in the U.S. at the moment where there is a major focus on that every single life really matters. And from this perspective, it really adds to a growing market as well for neonatal intensive care. So as preterm birth are increasing worldwide, the number of neonatal intensive care units continue to grow. It has created a very strong demand for improved monitoring solutions. The U.S. is then particularly attractive market because of their high rate of preterm birth, so 10.6% of all babies in the U.S. are born preterm, but also their focus on fertility treatments leading to a lot of twins and triplets and also older mothers, which is also continuously a trend that is driving the market in the U.S. And currently, there are 35,600 beds in neonatal intensive care in the U.S. And we, together with our market research, estimate that 50% to 70% of these beds are directly relevant to have a Neola next to it. In the U.S. alone, we have identified 10 leading children's hospitals as priority target for market launch. And importantly, we have already established relationship with 2 of them, so Stanford in Palo Alto and Cooper in New Jersey. And this is really laying out the foundation for early adoption. So we're not going super wide. We know exactly where to be and which hospitals to focus on. And during the year and Q4 specifically, we're very pleased to have been able to visit both Lucile Packard Children's Hospital at Stanford in Palo Alto and also Children's Regional Hospital at Cooper in New Jersey. And we -- here, we have been given an insight look in the clinical environment, really providing perspectives, I would say, from the 2 leading neonatal centers within the U.S. healthcare system. And for Neola, being able to be here really with feet on the ground in the clinical setting firsthand provides valuable insights into clinical routines, patient flow and very practical conditions where Neola may be implemented. And here, we met with neonatologists and clinical staff to discuss how Neola fits into the today's pathways, workflow, logistics and practical aspects that are very much relevant for our future real-world implementation of Neola. I would also like to highlight that we, as a small company, has been able to really secure collaboration with these major clinical hospital is an indication of the very strong interest in the clinical innovation that these centers and the NICU market broadly really has an innovation that can cause a real shift in today's monitoring of these babies. For the hospitals, Neola addresses, of course, a pressing clinical need, but also creates a cure financial value, which is important by enabling faster detection of complications, Neola has the potential to shorten length of stay in the NICU and reduce the number of very invasive procedures such as blood gas samples and chest x-ray. It can potentially also free up nursing time from manual observation, are key factors for these hospitals as the lack of nurses remains a very big problem in the U.S. So any type of medical device and innovation that can really help ease the burden of the nurses is very welcome in the U.S. hospitals. With that first company introduction and highlights, I want to go into our focus for 2025 and our key achievements. Our focus for 2025 is within 3 areas. First, we have initiated clinical studies, our FDA process and then also preparation for market launch in the U.S. And step by step, we have really moved from research validation through product development, human factor validation to now be advancing into the clinical trials on preterm born babies in Sweden. And we began the year of 2025, initiating our first clinical pilot study in Sweden following an approval from Swedish authorities. And this was the very first study that we have done on preterm born infants. We're very happy that we were able to get an ethical approval from the Swedish authorities to start it. And this study evaluates the safety and performance of Neola in preterm born babies. In addition, it's designed to demonstrate both the utility of the product and its compatibility within the clinical environment. The study also serves as a preparatory step to ensure that we capture any potential refinements of the product and the clinical study protocol before entering the clinical study in the U.S. So this was very much a risk mitigation strategy from our perspective. The patient group ranges from gestational age of 28 weeks and a weight between 1,000 to 3,000 grams. and a total number of 10 preterm born babies in neonatal intensive care. The study that is ongoing is conducted at Södra Älvsborgs Hospital in Borås and the study teams consist of experienced neonatologists and neonatal nurses. And in May, the first baby was successfully included in the now ongoing clinical study on preterm born babies. And this marks the very first time Neola has been continuously monitoring the lungs of preterm born baby and also within neonatal intensive care. And later this year, we announced encouraging early finding that this highly vulnerable patient group indicate that it is a very robust safety profile for Neola in this very first use on preterm born babies and it's very vulnerable skin. At the same time, the preliminary findings indicate variations in the data that provide valuable insights for us for further optimization of Neola before progressing to the U.S. clinical study. Overall, the process of the clinical study protocol for each enrolled baby has worked according to plan, and we now only have one more baby remaining to be enrolled. And then we will summarize and communicate key insights from the full study once all enrolled babies have completed the study and the data has been analyzed and the final full results are available. Going back to finance. During the first half year of 2025, we completed a directed share issue of approximately SEK 20 million, securing financing ahead of the ongoing clinical study start and also strengthening our shareholder base with our first institutional investors, Adrigo and Cicero, alongside support from our existing shareholders. During the year, we are also especially pleased to have signed an agreement with our first U.S. clinical study site, the prominent neonatal intensive care unit at Children's Regional Hospitals in New Jersey that we visited during Q4. Together with the IRB approval, so we have approval from the Institutional Review Board at the hospital. This is really a key regulatory milestone that enables the initiation of the U.S. clinical study on preterm born babies when we decided the timing is right. And we're very honored to collaborate with Dr. Vineet Bhandari, the principal investigator of this study. He is globally recognized key opinion leader in neonatology. He's also on the Board of Directors for the U.S. Neonatology Association, and his leadership really adds significant credibility and momentum to this very strategically important study site. 2025 has also marked a record year for the company's intellectual property strategy with 7 new patents granted within 5 different patent families across our key markets, Europe, China and the U.S. And with these 7 patents, Neola Medical continues to systematically strengthen our intellectual property base behind our core technology, our measurement methods that support both our current device, but also future clinical applications and also importantly, our disposable components, which is a key part of our revenue model. So our IP portfolio is now one of our most strategically important assets. And as Neola Medical has now entered the clinical phase, we reinforced the leadership team with 2 recruitments. First, a Clinical Director and then a Director of Disposable Products Development. And these roles really add expertise in clinical strategy as well as developing disposable medical products for daily clinical use and that full-scale mass production as the disposable components are very central to our business model and future recurrent revenues. We have decided to put a real emphasis on the disposable probes as of 2026. And with that, I hand over to talk numbers to CFO, David Folkesson.

Thank you, Hanna. As you can see, this year has progressed in line with the previous periods, and we keep focus on our costs being on an efficient level. And as we have discussed in this and the previous reports, we're now focusing on the clinical validation phase for Neola with preparations and executions ongoing and for the coming studies. This, as you can see, resulted in this year's cost being slightly lower than last year as the need for external resources has decreased as we enter this clinical phase of clinical validation. We try to continually to keep a financial focus on this path towards clinical validation. The clinical validation coming quarters will be a cost-driving activity. The ongoing study in Sweden that we started during 2025 is not as expensive as the planned international studies will be. We can also see that the burn rate for the company has been in line with previous year, slightly lower due to the decreased need from external consultants as we progress to the clinical validation phase for the time being. And if we go on to the next slide, Hanna. There hasn't been any major changes in the shareholders' table. We feel very grateful for this and thank our current owner and for the support and hope to continue that support. Thank you.

Thank you for that, David. And please do continue to follow up. This is our financial calendar. Next report will be released in May, and you also have our annual report being released in April. With that, I thank everyone for listening to the presentation today and also open up for questions.

Yes. Thank you very much, Hanna and David. I thought I'd begin with your additions to the IP portfolio. There's been 5 new patent grants here during the quarter, both in the U.S. and China. You're patented now across all your target markets. Could you give us a little -- how do you say, feel towards how your time line is currently towards commercialization?

Well, we're now very much in the preparatory step for commercialization going from -- going to this clinical phase that we're in. Of course, we're now really planning for commercialization. Our #1 market is the U.S. And we're as now to say the U.S. and top 10 children's hospital that we have continuously evaluated with those 10 hospitals, we're building very tight relationships with the key leaders of the neonatology departments. Within our industry, it's very important to work with the right key opinion leaders at the right hospitals. But also, it might sound like a small market with just top 10 children's hospital in the U.S. However, we're talking about 800 relevant beds for Neola in just those clinics. So our strategy is very much niche. We're going super-targeted. And we -- as you know, we have continuously worked on really building those key opinion leader relationships for many years now, and we could start seeing the effect of that, but we have a lot of more work to be done in the U.S.

But as it stands right now, how comfortable are you in the preparations that you've made so far in the U.S. market?

I think we're in a good place. It's quite uncommon for European companies to be so integrated in this niche market as we are in the U.S. A few years back, we started a subsidiary based in Palo Alto, and that has been immensely helpful for us as we have an American base, and we also act as an American company when we are on the U.S. market. Now the next preparatory steps will be to evaluate how quickly to scale in the U.S. As you know, we're very cost focused. And we're talking about a few sales reps that will be placed on the U.S. market as soon as we get positive indications from the FDA on our application to be granted approval.

And I assume then that you're moving towards the U.S. then first during your commercialization, but how far away are your other target markets?

Well, our second target market after the U.S. is Europe. We're in parallel preparing an application for CE mark for the European market. Our key focus is the Nordics, where we have relationships, also knowing that our technology and products comes and has been developed of neonatologists from Lund University Hospital. And then also using our collaborations with the most prominent children's hospital in Ireland. So Nordics, Ireland and also France with a few key selected hospitals in Paris is our very much next step. And also here, we have a very targeted approach. We have made sure to work with the best key opinion leaders in Europe for many years now, making sure that we have their input and support already from a clinical research phase. So in the early 2020s, we sold a research system, research device to this Irish hospital in order for them to start their own completely from the company, independent clinical studies. And that is the type of activities that you will see from us moving forward that we're supporting these key researchers to do their own independent evaluation of Neola so that it will then be successfully implemented in their clinics.

Let's talk about studies then in the pilot study that you have initiated. The preliminary findings have shown robustness, but you need to optimize the study a little bit and thus a revised time line. I was curious if you could elaborate on all these 3 points. What are the preliminary findings? What sort of robustness are you reading out of it? What needs to be optimized? And what is the new time line?

Great questions, and I'm sure that these are really key questions that the investors want to dig into more in detail. So the study is ongoing. So we're still remaining one patients before we can really gather the full data set, analyze the data and come back with a revised time line. But I would like to start with saying the reason that we did this clinical pilot study in Sweden before the U.S. study was really risk mitigation to make sure that we could find every single thing that could be optimized before going to the U.S. because as we're talking about very advanced medical device in intensive care, it is very difficult to, after our regulatory approval, make any type of changes. So -- and then we have put some pride in to always have a very transparent communication with the market, and that is the reason why we -- when we saw that we had some variations in the data that we needed to understand better and we could see that it's clear that we would do some optimization in the product before going to the U.S., we wanted to communicate that to the market. So it's more of a signal of our transparency, and we will make sure to communicate full results and the implications of the time line as soon as possible when all babies have been enrolled in the study.

Indeed. And if we turn to the chat, Gustav asks when you expect the last patient to be enrolled and when you can communicate these key insights?

Yes, it's always hard in the clinical setting to know exactly when the patient will be enrolled. If I would take a guess, it will be in the first quarter of 2026.

And do you aim to do similar studies in the U.S. as you continue to prepare for commercialization? If so, what do you expect to take with you from this study?

So for this study, it was the very first study that we did on preterm born infants. So we have learned so much about skin integrity and we're quite -- we're very happy to see a robust safety profile on these babies because that is -- safety is the key concern of the FDA, but also of the clinicians for adoption. So safety is a very important factor. And then it will -- an FDA approval will require a U.S.-based clinical study on safety that we know from previous conversations with the FDA.

And if we turn our attention then to CFO, David Folkesson I have some questions regarding the financial state of the company. You're exiting or you're entering rather 2026 with a cash reserve of SEK 60 million. How would you currently describe the financial stability overall of the company?

Yes. Money is always on the table for development companies, pre revenue. The Board of Directors keep a focus on this. And once we have something to communicate for financing, we will communicate it, but the Board of Directors are very aware of the situation.

Gustav asks in the chat, what is your view of cost development during 2026 directly compared to 2025?

It's very cost driven by clinical studies. And when the clinical study abroad starts, that study will be more costly than the ones we've done in Sweden. So it's -- that's a cost-driving activity once it started. Otherwise, we can expect the cost being slightly lower than this year for the ongoing activities for the ongoing business.

What is driving the lower costs otherwise?

Slightly less external resources going to a lower level than this year.

Thank you very much, David Folkesson. Hanna, I return back to you as we step into 2026. What are some of the most important milestones that investors should look forward to?

Well, now I'm sure that you as well as I want to see a finalized clinical pilot study in Sweden. And with that, to be able to analyze the full data of that pilot study, understand how that impacts our time line for the U.S. clinical study and ultimately also then our roadmap to market launch.

Looking forward to it, Hanna Sjostrom, CEO of Neola Medical. Thank you very much for being here presenting and answering our questions.

Thank you so much.