Mauna Kea Technologies SA ($ALMKT)

Hi, everyone, and thank you for joining us on this webinar for the presentation of Mauna Kea Technologies 2025 annual results and Q1 sales. We are joined today by Sacha Loiseau, CEO; and Come de la Tour du Pin, CFO. This conference call will be divided in 2 parts. First, Sacha and Come will present the results, followed by a Q&A session. [Operator Instructions] Sacha and Come, over to you.

Thank you, Elan. Good afternoon, good evening, everyone. Thank you for joining us for this webinar on our 2025 financial results and Q1 2026 sales. I will let you, of course, read at your pace, the usual disclaimer. So let me start by saying that 2025 was perhaps the most transformational year for Mauna Kea yet. And I believe this is true for 3 reasons that I'd like to go over before I hand over to Come for the figures. The first reason is obviously the acceleration of our commercial momentum in 2025 continuing in 2026. The sales momentum we established is rooted in very quantifiable and objective reasons that I will detail later in this call. The second reason is our path to profitability. We have made major improvements over the past 3 years, but in particular now, of course, in 2025, reducing our cash burn, our operating losses and being on track to reach EBITDA profitability by the end of 2027. Third, we have deeply transformed and strengthened our balance sheet and I want to thank here, of course, the support of all our advisers and lenders and shareholders. As we successfully implemented our Safeguard procedure, we can now say that our financial resources are fully dedicated to our business growth for commercial activity, rather, of course, than servicing debt and other issues. So in summary of this call, I would say that we have now a mature proprietary med tech platform that has rich product market fit whose risks have been considerably reduced and that is now entering a phase of sustained growth. It's a very exciting time for Mauna Kea Technologies. So on that note, I will hand over to Come, our CFO, who will walk you through the 2025 numbers in detail.

Thank you, Sacha. Good afternoon, everyone. So -- Well, let me start with what I consider to be the four most important numbers of 2025. Actually, so our total sale amounted to EUR 8.2 million with an acceleration in the U.S. quarter-over-quarter and amounted -- with the gross amounted to 38% at constant exchange rate. The adjusted EBITDA came at minus EUR 3 million, but with an improvement of EUR 1 million versus last year through a strong operating leverage and cost discipline as like -- just like in 2024 and 2023. We published a net profit of EUR 10.8 million, thanks to an exceptional income with the cancellation of our debt or part of the debt through the safeguard processing. And also total debt was reduced by EUR 26.5 million, 69% reduction, which also include the consolidation of EUR 8 million royalty commitment to the EIB. If we look now at the adjusted EBITDA and the trajectory since 2020. I think it's important to look at this because it's a good indicator of our operational profitability, our operational capacity to generate cash in the long term. And what you see, I think, speaks for itself, actually, we see an improvement of 70% versus 2020. And this is driven by 3 main factors. First, the top line acceleration, as I said, with an acceleration of growth in the U.S. and benefited from higher margin in this territory. We also benefited from the commercial leverage in all the organization, but especially in the U.S. with productivity gains. And I would say, senior management of our accounts. And then a strict financial discipline and we've been able to reduce our costs in across all departments. So this is positive. And in fact, we now have a leaner organization and this improvement in operating losses is structural. And obviously, we want to maintain this dynamic going forward. The same discipline shows in our operating cash burn and so you see that our cash burn was decreased by 34% versus last year and have since 2023. So there is 3 main things that I want to focus on this slide. First, this is -- you see that, in fact, the improvement in the EBITDA is translated in our -- on the reduction of our cash burn. So this is very positive going forward. Then what we've been working on and especially in 2025 is reducing our working capital through an optimization of the inventory and also collecting our strong condition in the receivables. And so today, we have a cash runway of early Q2 2027, which exclude any exercise of the relevance that were issued to our shareholders in November last year. And actually, we've seen a steady execution or to the exercise of those parents since January. So I think we could expect some additional exercises going forward this year if we continue to deliver and our stock price go up. So this slide, I think, totally reflects, in fact, the impact of the safeguard processing with a complete reset of our balance sheet. First, the equity is improving by EUR 20 million, thanks to the profit for the period, but also the support of our shareholders who participated in the capital increase in November and also the decrease in the financial debt of EUR 27 million. So concretely, this means 3 things: first, a strong deleveraging; second, an equity restoration and then I think this is the most important effect, which is now we are focusing all our resources, financial resources on investing on the operational growth and no longer toward debt servicing. Regarding the P&L, I think -- well, I already covered most of the numbers. So the key takeaway here is on the OpEx, which decreased by EUR 1.6 million in 2025 and is a clear testimony of a strict discipline in place in the organization. And so which means that today, we have an adjusted EBITDA, which improved by EUR 1 million compared to last year. Here, I want to just have a brief explanation on the COGS and our gross margin. As you see, in fact, our gross margin was impacted by several one-off impact. The first one is on noncash inventory adjustment. As you know, we've been tackling our balance sheet and cleaning [indiscernible]. The clear focus since 2023 was to clean up our balance sheet. So we did this with our debt and we continue with the stock of all generation system and all parts. So we decided to depreciate a significant portion of the stock. So this is why you see this impact in our COGS. And so we need to analyze our COGS, deducting this adjustment. And also, we were impacted in the U.S. by the import tariff. The good thing is that we've implemented measures to mitigate these tariffs. First, in optimizing our pricing policy towards our subsidiary in the U.S. but also what you may know is that today, we can fight for reimbursement. And so we did this on Monday on the U.S. portal. And so we could be in 2026, be reimbursed for those taxes. So I just -- if you adjust our COGS from those one-off issues, in fact, our gross margin is at 68% and close to 70% if you also exclude the depreciation of the dollar versus the euro in 2025. So we believe that is the underlying gross margin is pretty strong. And we have a strong focus on this and try to improve this going forward. Finally, we are reporting a net profit of EUR 10.8 million, which is benefited from strong financial results and especially an exceptional income of EUR 21 million, resulting from the debt write-off under the Sagard processing. So we are pretty satisfied by those results. And now I can hand over to Sacha.

Thank you very much, Come, for these very clear explanations. I want to now turn to a review of our commercial performance following last week the announcement of our Q1 2026 sales. As a reminder, our core product sales were a little bit more than EUR 1.5 million which showed the 68% growth at constant exchange rates. Among, I mean part of that was, of course, due to the growth in the U.S. the product sales in the U.S. topped EUR 1 million, growing at 34% at constant exchange rates. At the international level, outside the U.S. we achieved close to EUR 500,000, which represented a 326% growth with respect to last year, which was mostly due to the traction we're seeing on our food intolerance program branded CellTolerance. So we're very pleased with this momentum that builds on, again, a strong momentum from last year. So to compare apples and apples, we wanted to show the different -- the 4 last first quarters. And you can see here a significant, of course, increment this quarter. And I will -- I want to detail some of the key reasons why we're seeing this traction. As I've said before, with the significant amount of time and spending in the field in the U.S. I have seen in the past 12 months, a complete change of sentiment towards Cellvizio, especially on the pancreatic cyst indication. Following, again, as a reminder, early last year, about a year ago, the presentation of the CLIMB study results at Digestive Disease Week early May 2025. The inclusion in the European guidelines of Cellvizio for pancreatic characterization and achieving a critical mass of users have really driven the adoption of Cellvizio in a very significant way and unseen way before, and so that's extremely pleasing. I'm going to go back to some of the key metrics that we are now seeing in the commercial development. But if we look at sequential quarters, you can see that following what I just said, which was the DDW turning points. In Q2 last year, we have seen the momentum kick off and grow quarter after quarter. As a reminder, you're seeing here in gray, the licensing revenue which was an accounting recognition of revenue of a payment that was given by the joint venture in China with the large conglomerate Teslee, which was paid in full in 2023 and then recognized over 12 quarters. So the phaseout was, of course, expected and we are now really comparing, again, apples and apples with the 68% product growth rate. If we look at what's behind, as you know, we are selling Cellvizio with different business models. The first one is, of course, capital sales. And we're very pleased with the capital sales over the past few quarters. We've seen accelerated capital adoption, shortened sales cycles and that is almost entirely due to the pancreatic cyst indication. So 85% growth in sales of systems this quarter. Same thing with the mini probes that we sell, of course, either as recurring revenue or an initial, of course, package of probes and that is also reflecting an 84% growth this quarter. On our pay-per-use business model, we have seen a slight decrease this quarter, but frankly, it is not structural. It is mostly due to major weather disruptions in the first quarter in the Midwest and the Northeast, and other areas, actually, where some of our key users have been impacted and so have lowered their usage during this quarter, but we believe we will see a rebound of this usage trend in the quarters to come. And as for service agreements, we continue to see a steady recurring revenue growing year after year on this front. Now importantly, we see some of the key metrics of adoption that are absolutely reflecting this change of sentiment that I was talking about earlier. In particular, since I came back as CEO and Come joined us 3 years ago, we have steadily increased our pricing in the U.S. to about -- I mean, to precisely this year, the list price is $227,000. What you see here is that our discount rate on average in 2025, has fallen dramatically. And this is really a reflection of our pricing power and the fact that people are not seeing Cellvizio as a nice to have anymore, but really as a must have for some of the key indications. Same thing for Mini probes. We have steadily increased the pricing, and we see that the average discount has also been divided significantly -- of course, sometimes we offer discounts with volumes of probes and so on, but that's, of course, a fair practice. So this, in addition to the shortened sales cycles are really a reflection of a product market fit I was talking about and a very clear adoption of Cellvizio as a must-have tool for pancreatic cyst characterization. Now if we look at our second pillar of growth going forward, this is our CellTolerance program, which we have launched now about, I would say, 18 months ago, we have planted many seeds and we're very happy to see that this is starting to bear fruit. So this quarter, we have seen a very strong activity, in particular, in the U.S. with 3 new centers opening, 1 being a key center of excellence for us, and that's at Hoag Memorial in Newport Beach in Los Angeles, which is going to be, we believe, a replicate of the phenomenal success we had at Stanford with CellTolerance. As a reminder, Stanford cured or treated at least 300 patients in 2025. They acquired a second Cellvizio system for their second campus. And the Chief of Gastroenterology there actually moved to Hoag and Dr. Win is a phenomenal physician in the field of motility disorders and gut brain disorders. And the first thing she did at Hoag is to acquire a new Cellvizio system and launched the CellTolerance Program there. And if you follow us on LinkedIn, you can see that already Hoag has communicated on the first procedures, and we're very excited. I'll be there next week and very excited with that. Now we've also opened 2 new centers in the Midwest and the East Coast. And so we're starting really to expand our presence in the U.S. Same thing in Europe. We have opened a new center in Germany. We have a pilot center in Spain and a very important chain of hospitals, and we are working on some new regulatory approvals in Turkey, in the United Arab Emirates, and this follows, of course, the regulatory clearances we obtained in Switzerland and U.K. earlier this year. Coming up, a lot of exciting things in 2026, which I believe are value creation catalyst. As I said, in just a few days, I'll be first in L.A. then in Chicago for the big DDW conference where we have a flurry of activity. We have our annual symposium on pancreatic cyst, which is organized by Ohio State University and cosponsored by us, by tailwind Medical, by other sponsors. They will be an oversubscribed room full of more than 100 physicians, some will actually be following remotely. We have -- will be present on the TaeWoong Medical booth. There is activities around that. We have a big CellTolerance dinner with Dr. Win, Dr. Spencer from Stanford, being the host. It's completely over scribed today. And we have other activities, of course, regular at DW. So very exciting times. We'll see the activity with our partner TaeWoong Medical pickup after DDW. So we're very much looking forward to that. Later this year, we expect the French higher 30 for Health to align its evaluation on the European guidelines for Cellvizio and Pancreatic characterization. This would trigger the creation of an equivalent of a CPT code in France and obtain. We will then obtain reimbursement. As I said, we'll be opening new CellTolerance territories this year and we'll be deploying our Cellvizio link, which is a way to connect the Cellvizio systems, especially those which are used as paper use to the Internet and to send automatically log of utilization so that we can not only see the number of procedures, but of course, invoice based on these logs. So exciting times ahead. As a conclusion, I would just reiterate the 4 points that we have seen as Come clearly detailed a complete financial reset. We have massively deleveraged the company with a 70% reduction in our debt and with a EUR 20 million equity improvement. So we have really a fully derisked Medtech platform, and we have dedicated funds for its growth. We have shown a significant operating leverage and pricing power, very strong indication of clear adoption of Cellvizio we are showing that a clear execution on our path to profitability. This is, of course, one of our key objectives going forward. And importantly, accelerated commercial momentum, building in 2025, continuing in 2026 and we have the pillars of growth for that. So with that, I want to thank you for your attention, and happy to answer questions, if any.

[Operator Instructions]

Great. Well, thank you all, and we look forward to updating you on the upcoming news.

I guess it was crystal clear, and we don't have any questions. So thank you, Sacha. Thank you, Come. Have a very nice evening, and thank you, everyone, for being connected today.

Thank you. Bye.