UltraGreen.ai Limited

UltraGreen.ai Limited

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Q1 FY2026 · Earnings Call TranscriptMay 5, 2026

Operator

Welcome to Ultra Green's first quarter business update. As a reminder again, this is a business update.

There will be no financials disclosed in this presentation slide. With us in the call today we have our management team: CEO Ravi, COO Declan, CFO Eamon, and our Chief Commercial Officer Fidelma.

Maybe just as a matter of proceeding, our CEO has a family matter to attend to, he'll be with us for about 45 minutes, and the rest of the management will be taking the Q&A. I think with that, let me pass the mic over to Ravi to kick off the presentation.

Ravi?

Ravi Sajwan

Thanks, Roger. Thank you everybody for joining us on this call, and especially to our team in Ireland, which is various time zones.

I'm currently in India, I'll try to give you as much information as we can about the quarter, and then the management team can take any Q&As. Let's go to the next slide.

All right, before we focus on any of the numbers, what we wanted to point out is a couple of things. The 2026 we started with sustained volume growth, 281k vial shipped, which is a very strong number.

I would focus on the quarter-over-quarter growth. We'll explain to you the downward red triangle because it's important to explain to you why this looks that way.

What we focus on as a company is what I show in the right side. The global trend and what we do has consistently been upwards annually, and the number of surgeries where we are indicated continues to increase.

I use this example to share with you some very interesting metrics. In all the years from 2000 to over the last 10 years, approximately 10 million surgeries are basically being coordinated, and these include laparoscopy, which is gallbladder, colon tumor removal, breast sentinel lymph node, and breast reconstruction.

If you average the number of surgeries over the last 10 years, there are 100 million such surgeries which were done, and we've only enabled 6 million of those. Obviously, the market is very large, and what you see here is adoption trend of our product across the globe, including all the countries we ship.

The strategy we have is very simple. You create penetration in the markets we are in, you create adoption in the new markets we're going after, and then just keep growing the business.

That said, what I'd like to do is have Eamon, our CFO, walk you through the numbers here. [Regarde Sims?]

. [Sims, qu'est-ce qu'on mange, aimant?]

. Hello?

Oh, sorry, I don't know...

Operator

Sorry, just a reminder to all the participants, kindly keep on mute for the presentation. We'll have the Q&A after.

Thank you. Yeah.

Ravi Sajwan

Let's have Eamon, our CFO, walk you through these numbers to kind of give you the background, and then we can finish the remaining of the presentation. Eamon?

Eamon Lynch

Thank you, Ravi. Good afternoon, everyone.

Thank you for joining this afternoon's call. The key message that I'd like to present in the business update this afternoon is that we've had a very strong Q1.

Over 281,000 vials has been shipped, and that represents almost 8% quarter-on-quarter growth. The negative variance versus Q1 2025 is as a consequence of an exceptionally strong Q1 in Q1 in 2025, where there was a large backfill order fulfillment following the supply chain disruption in H2 2024.

We estimate that that backfill order was about 60,000 vials, and that flowed through the system into Q2. This was a one-off, but the key thing for me and the team as we analyze these results month on month is that the trend is growing exactly in the right direction.

We've had a very strong quarter, and even a very strong April. I think as we look towards the full year guidance, we're very comfortable that the revenue figures that we have guided in the 2025 results release in February for revenue guidance of between $170 and $190 US still remains on track.

The key point that I'd like to make is that the US was down 20% in Q1, and that is entirely as a consequence of that order fulfillment backlog repatriation. The rest of the markets across the world showed huge growth versus the prior year.

Some of our Italian distributor was up over 26%, the UK plus 13, DACH, Spain greater than 30% growth, APAC almost doubling. Our key metrics as we review each different market and all the ordering history trends to a really positive trend line.

As I say, we're tracking on track to our guidance. If you extrapolate out our Q1 figures, we're trending towards over 1.1 million vials being sold for 2026, which is exactly in line with where we're guiding, midpoint of where we're guiding.

As Ravi mentioned, the key point is that we're trending in the right direction. I think as an investor and the key point is on the right-hand side, top right-hand corner, the growth that we're demonstrating.

With the huge volume growths, the average run rate is increasing month on month. We're over 94k average run rate in Q1 2026, compare that to 82 for the whole of 2025.

Thank you.

Ravi Sajwan

All right. Roger, we can go to the next slide.

We also just wanted to point out how we actually are growing our business. Eamonn's point about the guidance, it's rock solid and we are in very good shape to achieve those numbers.

Key metrics from our perspective, is any change in global trends? We don't see any.

More markets we are getting approved in, that means the market size is increasing. The camera system we have, which is going to be launched very soon, is going to start enabling new markets for us.

What we're doing essentially in our growth levers, number one is continued ICG growth in current practices and current indications, but also increasing penetration in high-volume procedures. Then in addition to that, if you look at our prospectus, we had about 35 countries in which we had been approved as a product.

As of this week, we are in 41 countries, we added actually six countries in the last maybe a quarter and a half. We are in approval processes in more than 20 additional markets across Asia, which will tremendously provide a very wide coverage in terms of a competitive and a business moat.

It helps us expand our market share while our competition is trying to catch up with approvals. We had also mentioned to you that we're looking at data strategy.

I believe surgery, as you can see through robotics and how robotics is transforming surgeries because it's all technology-enabled, our dye, even though it's pharmaceutical, is going to have tremendous leverage because we are building our own software platform to quantify information. Robots and surgeons require quantification, and it's good to know that our quantification software, which is tested across multiple countries, is now in the process under EU medical device registration.

We expect sometime in Q2 to get that, and right after that we will do the FDA pathway. With that in place, in 2027 is when we are launching the product in terms of commercialization.

To remind everybody, we are in a healthcare business, everything we do today takes a minimum of 6 months before it shows up in the market. We are transitioning and getting our surgeons to understand our software better.

Once they start using it, we are transitioning them towards, in addition to what they do with a camera and the dye and the visualization, we are also trending them toward data-enabled workflows. That's a crucial part from a long-term strategy because now we have data which is very high fidelity, and no other company can get this data until they perform the surgery.

We have the chance to become a very unique data platform for quantification software. In addition to that, as we had mentioned, we are always looking out for large market segments.

We do it two ways. One is we identify the market and then try to figure out who are the key opinion leaders and market leaders in that space we could work with to expand the market faster.

We'll discuss this a little later, but we have made a $3 million investment via convertible note. It's optional, it's got very favorable terms, in a company or what I call an institute called IHLD.

This is the International Heart and Lung Transplant Institute, which has a large contingent of specialists who focus on wound management as well as trauma management. These folks have used ICG in the past, and they'll help us roll out wound management in India.

For someone who looks at the numbers, there are about 100 million such procedures that happen in India every year, and not a single one of them is enabled using ICG. ICG has a very strong role to play in this market, and we believe we have identified the right people to work with, world-renowned surgeons who are already using the product, have tested it, and actually will speak on our behalf.

When Fidelma gives you our marketing update, she can then guide you through how we take this information we are creating in India and launch it globally. Next slide.

This is an important slide. I think I mentioned most of it in the previous slide explanation, but if you can look at the number of countries, we are at 41 now.

The six countries you see including Singapore is now officially approved. That means the only other competition if you remember in Singapore we have is Daiichi Sankyo, they will have to exit the market since we are the only approved product.

Suddenly every procedure in Singapore will end up using our product. That gives us a very strong leverage locally, but also kind of gives you that insight that as we get approvals, other competitors have to leave the market unless they come back with a significantly different and very complicated dossier like ours.

The middle piece I believe is the strongest evidence of why this business grows. It's an extremely safe molecule, surgeons will try it.

There are hundreds of clinical trials going on, and the number of publications is close to 22,000, which shows you why surgeons write about this because of safety profile. More importantly, once they go past the safety, it's the information they're getting from visualization and quantification and what we provide them with the camera systems that gives a comfort to them that this product is as good or better than some of the old products.

Through various guidances, recommendations have strongly been sent by surgical societies that for gallbladder, breast SLN, colon tumor removal, and breast reconstruction that this product ICG be used in all surgeries. It's important to know what that essentially means.

Just to refresh your memory, if you look at ophthalmics or anything related to the eye, 70 approximately 70% of all procedures in the world use ICG, and the reason behind that, ICG has actually called out in the surgical guidebook as a standard of care. Once something becomes standard of care, insurance companies actually pay for that product.

With the amount of effort we have put in over the last many years through our team and the surgeons who've been using it, multiple societies are now recommending this product as a standard of care, and Fidelma will walk you through that. I also point out to a lot of folks that when you look at the right side, which is if you believe robotics and minimally invasive surgery will grow, which you can see the numbers it's growing, that what we do with the dye will become equally important because visualization using robotics is very complicated, and the dye gives you that very wide field of view, which gives you better outcomes for even robotic surgeries.

The next slide. This is what Fidelma focuses on, and I'll have her walk you through that detailed background on how this all works out in our favor.

Fidelma, please go ahead.

Fidelma Callanan

Thank you, Ravi. As Ravi explained really, as well as there are kind of key four procedures that we have been focusing on, and the reason why we're focusing on them is because the body of evidence that is there.

What we're seeing is that this evidence base is being translated into real clinical and also economic impact. Starting with the colorectal surgery, across multiple studies and real-world evidence, ICG is now showing a 34% reduction in anastomotic leaks, particularly in high-risk cases.

That matters because leaks are one of the most expensive complications in surgery, often up to €40,000 per case. Even small reductions have a major economic impact, and multiple studies now show that ICG is not just cost-effective, but also cost-saving for colorectal procedures.

Moving on to laparoscopic cholecystectomy, which is gallbladder removal, we see about a fourfold improvement in bile duct identification and visualization, and with roughly 8 million procedures a year across 40,000 injuries annually, the economic burden is significant, typically up to $60,000 per case. Again, better intraoperative visibility translates directly into avoided costs.

In breast and lymphatic surgery, detection rates are about 97% to 99% for ICG, comparable to radioisotopes, which are technetium, and better and safer than blue dye. It's a simpler, real-time, non-radioactive approach, which improves both workflow and efficiency.

Then if I move on to breast reconstruction, studies are consistently showing that up to 84% reduction in skin flap necrosis and around 69% reduction in flap necrosis. This means fewer revisions, shorter hospital stays, and lower complication rates.

Across all these areas, the story is consistent: better decision-making in real time leads to better outcomes and lower downstream costs. That's a key shift, so that ICG is increasingly not seen as an added cost, but as a cost avoidance tool.

If we go to the next slide, Roger. Then as Ravi said, there's a good bit of work I guess in terms of making sure that our marketing, education, and training are driving adoption.

In Q1, we continued to invest in structured education, webinars, distribution training, peer-to-peer engagement across key markets, including in Q1 Turkey and Germany, which are our big growth markets. We also launched a focus surgeon program in Spain.

We aligned to a center of excellence strategy, and we're building local champions who can drive adoption. At the same time, we maintained strong presence at major congresses, and these are congresses that, as Ravi mentioned, their key societies have advocated and recommended use.

SAGES, EAES in the US and also in Europe, the EBCC, which is a breast event, and also a gynecological event in Europe. This is not just awareness platforms, they influence KOLs, support guidelines, and inclusion, and help normalize use in practice.

If we look to Q2, we're building on this through SO and ISFGS collaborations, we're expanding training across Europe, we're developing fellowship programs with Georgetown University and the University of California in Los Angeles, for example. The key point is simple: approval is the starting point, adoption comes from education, clinical validation, and peer advocacy, and that's exactly what we're focused on.

Thank you, Roger.

Operator

Thank you, Fidelma. I know it's a pretty short deck of slides, but the purpose of the first-Q update is really for management to have a chance to chat with all of you, to take your questions.

Maybe I'll now open the floor for questions. If you have questions, just raise your hand, and I'll come to you.

Amanda?

Hi. Thank you for the presentation.

I just have a few questions on volume growth. How much of the first-quarter growth was first quarter '25 orders was due to back orders?

If we exclude that, what would be the normalized year-on-year growth in terms of volume for one quarter first quarter '26? How should we think about sequential growth from 1Q to 2Q to 3Q and 4Q?

Will Ultra Green still be able to achieve low-teens volume growth in FY '26? Yeah.

Thank you.

Eamon Lynch

Hi, Amanda. Thank you for your question.

It's difficult to exactly pinpoint the full back order that happened in Q1 2025, but management estimated to be about 60,000 vials, and that was primarily in the US. If you exclude that from the figures, it represents a double-digit growth in Q1 2026 versus the prior year.

Looking ahead, we anticipate continual growth. There is a slight dip in Q1 2025, and that was as the Q1 2025 inventory washed through the channel.

As we look towards the H1, I think as management and certainly at the end of April, we're very confident that we'll be able to show double-digit volume growth in H1 2026 v H1 2025.

Thank you. Okay.

Operator

Maybe Hong Han next? Hi.

Hello, everyone. Thank you for for having us for this presentation.

I just want to follow up on the earlier question by the lady with regards to the seasonality patterns, right? I think the guidance here you have given is on a year-on on a half-on-half basis, first half 2026 versus second half 2025.

Maybe I just want to bring back to the earlier question by the lady in terms of the seasonality patterns on a quarter-on-quarter basis. Should we should we think that your volume trend to be consistent as hospital inpatient stay?

On this basis, most hospitals in this region, say Southeast Asia or like Thailand, which is a medical tourist hub, will see third quarter as seasonally strongest, first quarter to be one of the weakest quarter. Your markets is largely in US and Europe, which could be quite different.

I'm just trying to understand your near-term outlook from this from here.

Eamon Lynch

Thank you for your question. No, we typically haven't seen any seasonality with our product.

As I say, 2025 was demonstrated some peaks and a few troughs just as we returned to normality following the disruption to a supply chain in 2024. I suppose you could say that there is a small bit of seasonality towards the end of the year in US, and that is more to do with kind of elective surgeries and insurance before the end of the year.

There's certainly nothing that would represent a trend in seasonality. Okay.

How should we think about near-term outlook in Q2 and Q3? Would it be consistent as Q1, flattish, or it could incrementally grind higher on a sequential basis?

Eamon Lynch

We don't have any one-offs or any exceptional items noted for Q2, and we would expect another strong quarter in Q2 2026. Even as I mentioned earlier, April has been really strong.

We're closing the books this week, but we're certainly on track to achieve our guidance for the full year 2026 at the end of April.

Got it. I have a second question.

Can I try to understand your pricing strategy for countries, say, in India? How does it compare with Singapore and US?

Is basically the pricing localized, like cost of medicine, where a Panadol tablet would vary from, say, Singapore and Malaysia? It would differ widely, but your production or distribution cost per vial is relatively fixed.

Trying to understand in terms of how the volume growth and the kind of margin trend going forward. Thanks.

Operator

Maybe India we can have Ravi, oh, sorry, Eamon. Maybe we just suggest Ravi to take this because he's going off.

Yeah.

Ravi Sajwan

No, actually, that's a very good question about the pricing, and I'll have Eamon jump into the local market. The way you have to look at our product is that in markets like India, we're not going to start by saying that we're selling a vial of the dye, what we're focusing on is procedures and applications.

If you look at the one subject we brought up about wound management, which is about 100 million cases in US, and hypothetically if I've only got 100,000 cases to do, we're not going to sell them the vial of the dye. The way we are enabling this market is the dye, the camera, our software, which is called wound management software as a platform solution.

In India, the way the healthcare system works is slightly different. It's mostly doctor-driven.

A doctor makes a decision on what procedures you need for a specific wound. We have defined multiple clinical work streams: so work streams for diabetic foot ulcers, work stream for trauma wounds, works for accident wounds, and each of them uses our dye with some technology which we provide.

The investments we are making in launching this product in India is based around the acceptance in the application market, and that automatically means that they will actually take that vial of dye from us. That's number one.

The second question then becomes, how do you price these things? When you price a procedure in India, to give you an example, if you had a foot ulcer procedure, people pay up to $500 to $600 equivalent for the procedure.

Take all the costs out, our camera is fairly low-cost device, it actually represents a significant profit margin for us because even though the dye might be a certain hardware or a capex, everything else is software-based. The key metric we are looking at is application-driven growth in countries like India or where we've identified large problems which can be solved by ICG.

One of the focuses we've always had, ICG is indicated for amazing things so far, but certain large markets where it has not been used, we are enabling those markets with our camera and the vial strategy. I'll stop there and have Eamon jump into the pricing now.

Hopefully that was a little bit helpful because I wanted to distinguish between a pharmaceutical and a procedure. We are procedure-based as far as India is concerned right now.

Eamon Lynch

Thank you, Ravi. Yes, as part of our pricing, we always review each market independently of each other.

As everyone on this call will be aware that the ASP in North America is much higher than the rest of the world, and that's just a function of different markets across the world. In the non-US, particularly in EMEA, we're very conscious of the different markets, but we're also aware of parallel trading, import tradings.

We're very conscious to manage the price within a specific range. We review each market prior to entry, in conjunction with the distributors, in conjunction with KOLs, our own independent market research as to what the correct price of entry into that market should be.

Operator

Hong Han, you good?

I have one more question, if you don't mind. I'm just trying to get some insights in terms of the framework, the way the revenue guidance is set, right?

Revenue basically consists of two elements, right? You have pricing, you have volume.

Between these two attributes, I think the pricing trend is more visible because you're in control, but volume can be a bit more tricky. I'm trying to understand in terms of management, in terms of setting your volume forecast, is there some kind of rolling numbers that you get from your doctors, your physicians there?

Just some backdrop in terms of how you looked at it and how you forecast would be useful. Thanks.

Ravi Sajwan

Eamon, you can talk about how the distribution folks buy it in Europe. That might give a good insight into how this works.

Eamon Lynch

Yes, thank you, Ravi. I suppose we we don't have the full data as to where the the vial ends up being used and across the different hospitals, but we certainly have data with regard to the order and order patterns within the within the for the product.

Particularly in in non-US EMEA markets, as we review the patterns, what we're seeing is the same order quantity, but a lot more frequently. If I if I take one of the larger distributors in in Italy, for example, they typically in, 2024, 2025 used to order on a bimonthly basis, every 8 weeks, and we're seeing that order pattern come into one every 6 weeks.

While the volume still remains the same, it demonstrates a huge growth in the underlying demand for the product within that specific country. We're seeing that in in in most of our larger distributors.

Within the US, it's it's primarily just an increase. Through the GPO system, we're just seeing larger volumes being ordered, every week as we as we ship on a weekly basis every Tuesday.

We're just seeing larger volumes go through month on or kind of week on week, month on month, and just the average is is generally trending in the correct correct direction.

All right. Thank you so much.

Thank you, very clear. Appreciate that.

Thank you all.

Operator

Thanks, Hong Han. Shekhar, sorry for keeping you waiting.

Hey.

No worries. Thank you so much for ending this call.

I have four questions. I'll start with the first one.

You have four new sorry, five new countries or six new countries into your geographic expansion where you now are licensed to sell this product. How does this enhance or increase your total addressable market?

Is there a number that you can provide? Second one is on your quantification software.

You said likely launch of 2027. If I had to weigh this against the India market access, which one comes first?

Would you be getting into the India market first or the quantification software comes first? Third is on your India investment, it's $3 million US via convertible note, and it is going to scale up to $12 million.

How should we look at this investment, and what's the time horizon we are looking at? Finally, on the standard of care, it'll be good to have any update on those four procedures and where we are in terms of achieving that standard of care approval.

Yeah.

Ravi Sajwan

Let me address the two middle questions, which are India-related, and then we'll have Fidelma and Eamon take the other ones. In India, if you look at wound management, it has multiple ways it is done.

They use ICG and our camera, currently that data we provide them is more than enough. They don't need to look at perfusion evaluation, they look at more wound management using thermal imaging, which we also have in our portfolio.

If you combine that together, the India market has actually done, believe it or not, 25 procedures in the last 4 weeks. Now, I'm not using that as a way to guide into revenues.

All I'm saying is that it's very well understood how they're going to do it, and we are finalizing the protocol in the next maybe 2 months. Once that is done, this specific group of practitioners we're working with will adopt that protocol and go to the market.

We'll see procedures being done, data being collected, some revenues from that. That's one piece.

On the other side, when you talk about perfusion software, the reason we use the metric for 2027 is the software was developed actually with surgeons working with us. Once you get all this stuff done, you've got to get your approvals in place, and that typically takes anywhere from 3 months to a year based on where we are in the process.

We believe Q2 for CE and end of the year for FDA. That will give us the official PowerPoint and bullet plan to go back to surgeons and start getting it adopted through ISFGS and the different organizations.

We have a plan in place, and that's the reason I mentioned India is more focused on wound management using the camera, the dye, and wound management software. Perfusion is mostly focused on today how do we deal with the current indications and give more quantification information for those.

Having said that, India can also use perfusion software, but it doesn't have to wait for it. I'll stop there before Fidelma and Eamon jump into this.

Eamon Lynch

I can address the first question on the number of additional countries. These are important milestones for the company, and as we alluded to earlier in the presentation, what they do is they protect our product within the market.

Taking Singapore as a prime example, Daiichi Sankyo sell their ICG product within the market. As of now, now that Singapore has approved ICG, Daiichi Sankyo are prohibited from selling their product into market until they meet our regulatory dossier standards.

That is a key win for us, and it enables us to gain greater market share within that country. The thing with a pharmaceutical product is that it just takes time.

It's a really strategic milestone, but it takes time for it to flow through into the financial impact. That's because it takes time to educate the market, it takes time for the competition product to wash through, and it takes time for adoption within each of the different markets.

There's no doubt that it's a significant win. It increases our presence, and it's a longer-term penetration growth rate.

The key thing for us now is from the commercial teams to gain leverage upon this approval, to get out into the marketplace, to start speaking with our KOLs, start speaking with procurement departments within each of the hospitals, within the surgical network to educate the market that this is the only show in town, that this is the only product that we can use as part of a fluorescent-guided surgery. Yes, really important, and, as we've always alluded to in prior presentations that the six the five that has been presented today is only part of the story.

We have over 20 filings in progress, really important. Fidelma, on the standard of care?

Fidelma Callanan

Yeah. No absolutely.

I think it's really important that point that both Ravi and Eamon make, is that when you do get approval, it does take a little bit of time to kind of wash through, but it does create a clinical foothold that it does then enable us to do training, build our KOL networks, build engagement, and support the inclusion in protocols. That's really what's important in what we call standard of care.

Standard of care is, I suppose it can be different things to different people. It can be standard of care in a hospital, it can be standard of care internationally, it can be standard of care in a particular territory.

What it is really all about is this, using the recommendations, as have been the case from, as Ravi mentioned, some of those key societies: SO, EAES, SAGES, the gynecological societies. They now are promoting or advocating that the use of ICG as the standard of care in these key procedures that we talked about.

They now are there, they are now well-established, and now what it really is is kind of working its way through. That's being taken on by peers, by surgeons, and then working it through their hospitals.

That is then when we come in and we actually do the training, we do the education, as you can see on this slide here, webinars and peer-to-peer training. That all is, I suppose, kind of switched on almost when these societies advocate use, and then it really does become standard of care.

It's a hard thing to exactly measure, but we've done an awful lot of work on it. As you can see by these key papers, and these papers are all I think either the end of last year or this year, this really is kind of helping to support and to reinforce that the surgical societies, surgeons in general, are using it because it is safe, it is important, and it is making a huge difference not only obviously for their surgeries, but also economically.

It's a hard one to exactly pinpoint, but we're certainly going in the right direction. Say, for example, that colorectal paper, what that is saying is that the time is over now for assessing, that now it's the time for using it in every surgery.

These do help, and that's kind of reinforcing. When surgeons start to use it, they are kind of taking their lead from these key opinion leaders and also these key peer-reviewed publications.

Thank you, Ravi, Eamon, and Fidelma. Eamon, can I just come back to you on that first question?

There are five new markets here. I'm assuming there was already an existing player which was selling ICG in these markets.

Now that you are the de facto supplier, what I'm trying to understand is what is that incremental volume that you can now address immediately with you becoming the only player in these five markets? Then it adds up to the broader question is what is the total addressable market in these five countries?

Eamon Lynch

Thank you for that. A lot of these markets are relatively small with regard to adoption that we have currently in place, and there's very little competition within Saudi, Kuwait, Colombia, Philippines, Georgia.

Singapore is probably the most obvious one. It'll be a gradual approach.

What we have done is we've appointed distributors within each of these, and obviously they will review the market independently. We have all the kind of the TAM analysis.

I'm not sure we'll go into the detail of each of those within the markets, but what it does is it represents an opportunity for us. From my perspective, it increases the global presence in each of the different markets that we have.

It takes adoption and it takes time. We are confident that the penetration rates within each of those will increase now that we've approved markets.

Essentially, what it is is we used to sell these products under exemption into some of these markets, and it gives just more credibility to the product now that it has been approved by the regulatory authority within each of these respective markets. It gives more surgical credibility.

Not that it ever needed it, but it was just that surgeons now see it as part of the regulatory approval process. Some surgeons are conservative by nature, and so they're reluctant to work under exemption.

Now that it has been fully approved, we can see the adoption will increase, and the market will increase for each of those.

Fidelma Callanan

If I may, Eamon, what may help is, we said in Switzerland is a very good example. We and a competitor was in the market.

We got approval, they were kicked out of the market. It took about 6 months actually for that kind of to wash through in terms of growth, but now we have doubled our sales in Switzerland as a result because we are the only supplier of that product.

What we have done now is obviously we're continuing to grow the market education, say grow off that base. Really, in essence, it's really good to get approvals.

It means that we have clear line of sight of the overall market, but it does mean we have to do other work as well in terms of growing the market, making sure that surgeons are educated and understand the value of the product in and of itself. It's kind of twofold.

We get the benefit of other competitors being kicked out of the market, but then also we get the opportunity to grow with ourselves. It's kind of twofold.

It does show that certainly the trend is and also they don't need to go through the kind of the arduous process of getting exemption, doing it on a kind of maybe a case-by-case basis. It's like a free market then once that approval is in that market.

We do expect growth, but it can take a few months for this to wash through.

Great. Thank you, Fidelma.

Thank you, Eamon. Just one last follow-up.

Eamon, in terms of the volume growth guidance that you're talking about, does this five countries already get factored in when you provide these guidance?

Eamon Lynch

It kind of follows on from what we're saying, that it's going to take kind of 6 to 9 months coming in, but they were in our pipeline, and they were as part of the forecast, yes.

Okay. Thank you so much.

Operator

Thank you, Shekhar. Any other questions from the floor?

Just raise your hand. Amanda?

Hi. Just wanted to ask in terms of your lyophilization capacity, which expanded from one to four lines, as well as the dual sourcing for API, could you comment on how much cost savings you see from those?

The second question is on your inventory and the inventory at distributors as well. Maybe could you share more on the trends of those inventory trends?

Operator

Maybe Declan?

Declan Cassells

Thanks, Roger. Hi, everyone.

I think on our as as we talked about, we've we've increased our lyophilization from one site that we had in 2024, and we we did detail that we had a supply disruption that did show that outlier in the volume of 60,000 vials, as Eamon mentioned, in Q1 2025. We currently have four locations now doing lyophilization for our product, qualified and validated, and we're actually working on a on a fifth.

That gives us ample capacity to grow and to meet the demand on our product. Currently today, we can produce about 3.5 million vials doses, if required, and we have that capacity in that supply chain.

We also have the first stage as we may recall, the manufacturing process is a two-stage process. The first process is API, which is the active pharmaceutical ingredient, and we have two suppliers on board manufacturing that that has sufficient capacity to scale to meet the demand from our lyophilization process.

Sufficient capacity in our supply chain, and if for some reason that we did have some disruption at one particular source or CMO in the future, we have redundancy at the other locations that protects the business as as we move forward. From a pricing perspective, I suppose we're very much focused we've, we take our cost of goods.

We more our focus has been increasing capacity. It's similar pricing across the sites, but there is volume discounts.

As we increase and scale this business more, we're going to see more improvement in margin over time as we increase that volume, but we have the capacity to to manage that. From an inventory perspective, we have ample inventory in the supply chain.

We have more than 6 months for all markets. If you recall, our product is a very stable product.

We have it well-tested, it has a 5-year shelf life. We we know we at minimum are carrying 6 months inventory in all markets, but we can we have our opportunity to increase that further as required.

That's goes back to the, we're ready to as the market continues to grow and it's the good work we're doing as Fidelma detailed through here in the education and training and awareness and driving that adoption and bringing on the new markets, we've enough product behind the scenes to make sure that we can in feed the markets and meet the demand that's coming. Hopefully does that does that answer your question, Amanda?

Thank you. Then in terms of the inventory at the distributors, I think just now you guys were saying that the orders are coming in more frequently.

Do you expect that trend to continue increasing? Maybe could you comment on whether Q4 would be Q4 would be sequentially higher than Q3, and Q3 sequentially higher than Q2?

Declan Cassells

Do you want to cover that, Eamon?

Eamon Lynch

From an inventory perspective, I suppose it takes time to manufacture the product. It takes about 6 months, but we're managing our manufacturing in line with forecast, and we're managing our inventory levels accordingly.

I suppose it's up to each of the individual distributors to manage their own respective markets and their ordering with that. As I've mentioned earlier and kind of repeating what I'm saying is that the orders are increasing with frequency, and we're very comfortable with the inventory levels that we have on hand.

We're able to supply accordingly.

Declan Cassells

Yeah. Maybe just to clarify a little bit more on that is currently with our suppliers, they are, as Eamon detailed, give the example of Italy, where the order was 8 weeks down to 6 weeks.

Generally, what we're working on our inventory, we have more than enough product, but they are ordering within every month to 6 weeks. We have, I suppose, ample supply product behind, as they increase their demand and growth in their markets, we can support that.

The trend is that as you see in the chart in the first slide that Eamon and Ravi presented, we look at the trend over the last 10 years, we're continuing to grow. If we look at Q1, the growth we have of Q1 this year versus Q4 of last year, we're up at 7.8%.

As Eamon with the guidance he's given, we intend to continue to see growth and growth and growth on growth quarter on quarter as we continue to drive this business forward. We're doing a lot of work in helping and accelerating the markets.

I think a key thing that maybe for everybody on the call here is the approvals in each region is critical to the business, and that allows us to invest into the market, to drive that education and training. Fidelma mentioned there that with surgeons, once it's under exemption, it is a kind of special access, and the surgeon has to request the product.

It's difficult as a business. You're restricted from promoting the product once it's under exemption.

Once you get your product approved and registered in-region, then you can promote. You can work with the camera providers, you can work with the different societies, the surgeons, the KOLs, and drive that adoption, education, and awareness, and see the value this brings.

That does take a certain amount of time. Each market is really important, and as a business, we're definitely very pleased that we've 41 countries registered now for our ICG, and in addition to that, the Novadaq camera is in 50-plus more countries approved.

We'll continue to help accelerate the market from here.

Operator

Thank you, Declan. Maybe I will just call out for one of the question on the chat, which is, "With regards to the API supplier, what's the breakdown now in terms of the supply coming from Organica versus TopChem?"

Declan Cassells

Organica is still our main supplier. TopChem have been all validated through our lyophilization process.

The key thing with TopChem, we own the drug master file as well, they're scaling up their manufacturing product currently. Over time, we will continue to probably balance it out 50/50.

We will continue to keep Organica on board as well. It is important because even from a registration perspective, even though we have the suppliers validated, we do have to register per region in each country as well to bring on the different suppliers, so that will take a little bit of time.

Definitely over the next year to 2 years, we will continue to register TopChem across any markets we're in as well today. There's more than ample capacity at both locations to meet our demand.

Operator

Thank you, Declan.

Eamon Lynch

I suppose if I to directly answer the question, it's difficult to actually quantify, but I would say that's probably 90%, 95% Organica, 5%, 10% TopChem. As Declan alluded to, as we go through the regulatory process and get TopChem approved in all the different regions as part of the drug master file, and that will obviously shift as well.

Operator

Okay. Maybe I'll circle back to an earlier question by Shekhar.

Ravi, this is for you. With regards to India investment, what are we looking at to scale that up from $3 million to $12 million?

What are the milestones? Ravi, you're on mute.

Ravi Sajwan

Okay. Everybody hear me?

Okay. From a timeline perspective, the way we have structured the cap table or term sheet is it remains optionally convertible at an 8% warrant.

We have the choice to invest up to $12 million over the course of next 3 years, and that's based on a fixed valuation which has already been decided. Our key metrics on how we will invest more is by actually increasing our revenue from this specific market.

The folks we are working with have a strong presence in New Delhi. This early investment of $3 million allows us to launch two clinics in the Delhi area and get the process started.

Once we have better handle on the cost structure and what the market size will look like, we'll decide how to expand. That's where we are right now: $3 million and up to $12 million over the course of 3 years at our option actually.

We might choose not to invest anymore if the business isn't doing great. It's totally up to us.

Great.

Declan Cassells

Thank you, Roger. Thank you, Ravi.

Ravi Sajwan

Sure.

Operator

Thank you, everyone. Are there further questions from the floor?

Just one final question from me. There are 20 additional markets in which you are seeking approval.

Which country are you looking to get approval first, or which countries would you be looking at? Are those markets significant, and do you supply under exemption in those markets?

Declan Cassells

Yeah. In the markets that we have, APAC is a big area, is a growth area.

There's a lot of different regions across APAC that we're going to continue to register in. In most of them regions, we are selling under exemption today, we would have a foothold in them regions.

We obviously would have the know-how, the camera providers in them regions, the hospitals, the network. We do do that, Amanda, before we go into each region.

We would check and understand the market before we enter. It does vary.

Obviously, that we have registered in each country. It does take time, some of these registrations has taken place maybe 2 years ago, a year and a half ago.

They'll only feed through at this stage, and we are at the mercy of the regulatory authorities in each country and the speed they go at. It is mainly in line with our growth strategy, it's really growth and expanding across the Asian market.

We have significant penetration, as we know, across Europe with more than 95% market share, and obviously within the US. Asia is a big growth area we've targeted.

Thank you.

Operator

Maybe one question from the chat. Eamon, this is for you.

"Can you share the opex increase we expect to see in 2026?"

Eamon Lynch

A kind of a good question, and it stems from some of the market releases that we've had earlier in the year. I suppose as Ravi alluded to earlier, we're developing and investing in the future, and payroll is probably our largest opex.

It certainly is our largest operating cost. We've obviously increased the head count towards the second half of 2025 by bringing on perfusion tech and investing in our data platform.

They will have a full-year impact in 2026. Our head count is probably over 100 at this stage, and so that's kind of going to reflect in our operating costs.

This is a business update, I suppose you'll appreciate that while I can't give the specific figures, I think the key point and the key message to remain is that this is an investment going forward in our people and that will lever out towards 2027. I suppose it's really important that we kind of track towards our margins and what we forecasted within our forecast, and that we're very comfortable in what has been shared by some of the analysts previously that that still remains our core forecast and our budget for 2026.

Operator

Thank you, Eamon. Any last question?

Okay. Otherwise, we'll call an end to this update call.

Thanks, everyone, for joining us, and as usual, just feel free to reach out if you have any questions. Thank you, everyone.

Thank you, everyone. Thank you, everyone.

Thanks, everyone. Bye-bye.

Thanks, everyone.