Okay, let's begin. Welcome to Aroa Biosurgery's Investor Webinar and Q&A following the company's full-year FY 2025 results and FY 2026 outlook announcement released this morning. Please note participants are in a listen-only mode. There will be a presentation lasting approximately 40 minutes, followed by a Q&A session. The webinar will conclude at approximately 10:00 A.M. Australian Eastern Standard Time. If you have a question you'd like to submit, please type it in using the Q&A function. We will also endeavour to answer some live questions, so you can use the raise hand function to do that if you would like to. Please note that this session is being recorded. On behalf of Aroa today, we have Brian Ward, Founder, and James Agnew, CFO. I will now hand over to Brian and James. Please go ahead.
Great. Thank you, Sarah, and welcome to our full-year results call. It's a pleasure to be here and present you with our final year results for FY 25. I'm going to jump straight into it. Normal disclosures. Just in terms of the structure of the presentation today, I'll have a short overview of the company, particularly for those that are not familiar with the Aroa story. We'll then jump straight into the financials. James will talk through the financials. I'll then go through and review operations, our strategy, and outlook for the next year. In terms of overview, for those familiar with Aroa, you'll know our story. We're very focused on unlocking regenerative healing for everybody. What we mean by this is these regenerative biomaterials have typically been limited in their use.
In healing, we think there's a huge opportunity to grow this market and for many more patients to have access to this technology. What we're doing is we're focusing on three things. Number one, world-leading outcomes, showing that our platform technology, our products deliver best-in-class performance, unmatched value to show that not only do they perform well clinically, but they also save hospitals a significant amount of money. Thirdly, widespread impact. What we mean by this is impact across a wide range of procedures so that they're helpful in healing in many types of injury, but also that they can have impact for many more patients. Aroa at a glance, we're a well-established, high-growth soft tissue regeneration company. We have four families of products that we sell, predominantly in the U.S. into hospitals. All of our products are based on our AROA ECM platform.
This forms the basis for new products, but also for line extensions. For the product for the markets that we're targeting at this point in time, the total addressable market is in excess of $3 billion. In the U.S., we're selling through two commercial arrangements. Firstly, Aroa direct sales team, and then through a partner, TELA Bio, for hernia and breast reconstruction. Our products have been widely used. They've now been used in over 7 million patient treatments. We've had a huge amount of experience with this technology, showing that it is not only efficacious but also safe. A big milestone for the company this year is that we now have over 100 peer-reviewed publications supporting the use of our technology in regenerative healing. That includes over 4,500 patients published in those studies.
A large body of clinical evidence is now developing to support the use of our technology. I'll talk more about that later in the presentation. Regulatory approvals in over 50 countries. Most of our focus is in the U.S., but we are building out local distributors in other parts of the world. We see that part of our business expanding over time. We have a second technology platform. That's our Enivo tissue acquisition platform. This is a new platform for us, not commercial yet. We're working through the commercialisation of this. I'll talk a little bit about that later in the presentation. All up, we're about 270 people, a team of 90 or so in the U.S., and then the balance of the team based here in New Zealand. Now I'm going to pass it over to James for the financials.
Thanks, Brian. Total revenue for FY 2025 was AUD 84.7 million, which exceeded our guidance of AUD 81 million-AUD 84 million and reflected a 23% increase on FY 24. Product gross margin was 86%, supported by the increasing sales mix of our high-margin Myriad products. A key milestone for the company this year is that this is the first year since we've listed where we recorded a normalised EBITDA of AUD 4.2 million, which also exceeded guidance of AUD 2 million-AUD 4 million and was a big change from last year's EBITDA loss of AUD 3.1 million. We ended the year with a cash balance of AUD 22 million and debt-free. Moving to product revenue, product revenue was AUD 84 million, growing 24% on last year. Endoform sales, making up that product sales, was Endoform, which in line with expectations remained flat.
However, large contribution to product sales this year was 38% growth in Myriad, growing from $23 million to $32 million. Sales to TELA Bio increased $22 million. Total revenue for all of Aroa's products in U.S. dollars grew 14%, growing from $85 million to just under $100 million for the year. If we look at the sort of key sales metrics of Myriad during FY 2025, there was a real key focus on increasing sales productivity and account penetration. During the year, this was represented by the sales growth in Myriad of 38%, with customer accounts only growing 22% and the sales headcount only growing 7%, ending the year with 52 salespeople. Looking at the financial results in a bit more detail, as I mentioned earlier, total revenue was up 23% on the previous year.
We saw a large step up in the second half of Myriad sales growing 18% on H1 and TELA Bio growing 15%. Gross margin was up 1% or 100 basis points. Operating expenses, we looked at, we did constrain those during the year, only increasing 9%. As a result, achieving a very strong positive normalized EBITDA in H2 and ending the year with a full-year EBITDA of $4.2 million. Cash flow, again, another key milestone for the company was achieving positive operating cash flows and actually total net operating cash flow break-even in H2. If we look at the full year, operating cash flows from operating activities decreased, or the cash outflow decreased by 65% compared to the previous year. Investing and financing activities also decreased 36%, and our total cash burn was down 50% compared to FY 2024.
If we look at the sort of key investments that Aroa has made over the year, sales and marketing only grew 12%, which reflects our focus on increasing sales productivity during the year. We continue to invest in our clinical development activities and our R&D spend in terms of new product line extensions. However, we did constrain this with clinical expenses remaining fairly constant on last year and R&D decreasing from 17% to 13% as a percentage of product revenue. Again, ending the year in a strong cash balance of AUD 22 million. With that, I'll hand it back to Brian.
Thanks, James. I'll talk a little bit about operations. What I'm going to do is go through and talk about each of our products. Myriad is the star product, certainly for our Aroa direct sales team. We're focused on large complex wounds. These are particularly wounds in trauma, but also lower limb salvage procedures. This is what's driving success for Myriad. If you think about these procedures and the value that comes from these procedures in hospitals, probably half of the value comes from large complex wounds and 25% from lower limb salvage procedures. We're focused on these two areas because that's 75% of the value of these procedures in hospitals. We're doing well on these procedures, which is really heartening. We're releasing some very compelling clinical data.
I think most notable in the last year has been the lower limb salvage study from Lawler. What we've seen here is high rates of healing, quick healing, filling in of tissue deficits, no complications, and only a single application. That is quite dramatically different from what's been seen with other technologies. We'll talk a little bit about that in a few minutes. We're also seeing that Myriad performs well across a wide range of different soft tissue procedures. This is important because the 75% of procedures that I talked about in terms of large complex wounds and lower limb salvage, they're critical in terms of becoming the standard of care within a hospital. It is also very helpful if your product can also cover those other more minor procedures.
What we're beginning to see is that Myriad has a huge amount of versatility and use in the wide range of procedures that happen within hospitals. Oral surgery is a very good example. Oral surgery typically is a hostile environment, and products tend not to perform particularly well in this area. We've seen great outcomes for Myriad in oral surgery. We're beginning to be able to build out the story that not only does Myriad perform well in the key procedures, but it also performs very well in these more minor procedures that are also part of the mix. The other very interesting study that we published this year is in complex facial trauma. This was a study by Dr. Dardano.
What this showed is the way that this material turns into the tissue and the early vascularisation of this tissue compared to what's typically been seen. What we know about Myriad is that it has these vascular channels in it. Those vascular channels allow the establishment of an early blood supply. That early blood supply is very important in healing. Now we have evidence to support this in a clinical setting that builds on what we've seen in pre-clinical studies. We've also been doing some line extension work for Myriad. We've launched Myriad with a portfolio of products that addresses most procedures. There are some procedures that require specific considerations. We're taking this into account in the way that we're building out our portfolio. We've now developed a meshed version of Myriad. This is the first version of it.
We're beginning clinical evaluation of this product. This will help us to round out the portfolio and make sure that we can address all of the use cases in soft tissue reconstruction in hospitals. All in all, we're very pleased with how Myriad's going. Growth is strong. We see that it addresses most of the procedures in hospitals and performs very well. We think it offers a huge opportunity for standardization within hospitals on a single technology that performs well. What's different about Myriad? I think there's three things that really stand out. It brings breakthrough value to hospitals. When I mean breakthrough value, something that hasn't been seen from this biomaterial before. It restores tissue, and it does this quickly, and it does it in a high-quality way. We see minimal complications. Typically, Myriad only needs to be used once.
What that means is that the patient doesn't need to go back for multiple surgeries, and it frees up operating room capacity and surgeon capacity. It is important from a hospital operations perspective. It is also important from a cost perspective for hospitals as well. Typically, they get paid a fixed fee for dealing with these cases. If they don't need to have multiple applications of the product, that can be a significant cost saving for them as well. We are seeing great clinical outcomes, operational improvements for hospitals, but also financial savings for them as well. We think this really sets up Myriad as being quite distinct from other products that we're competing with. Symphony, this is our product for chronic complex wounds. There has been reimbursement uncertainty in this market for some time.
We did a soft launch of Symphony last year into hospital outpatient departments. We decided to pause that launch because we were not reimbursed in our physicians' offices, and hospitals were resistant to bringing us onto their formally unless we were reimbursed across the whole continuum. We have paused the launch of Symphony. We do not believe that is constraining the growth of our business. We have plenty of opportunity on Myriad in hospitals anyway. We are really setting ourselves up for success with Symphony in the coming 12 months. As people will know, we are completing a randomised control trial with Symphony. This is expected to conclude in the third quarter of 2025. This is now required for reimbursements for Symphony. There have been a number of products that have been sold into this market. The rules are changing.
In the future, it's only going to be those products with randomised control trials that are going to be reimbursed. This sets us up for success. We also think it's going to take many of the competitors out of the market and presents a very good opportunity for Symphony. We're likely to be reimbursed in the physicians' office in 2026, and therefore we'll have full coverage and be good to go. I think the other important point with Symphony is that it fits with our Endoform business as well. We see that bringing Symphony online will also be a boost to our Endoform business because we're spending more time in the hospital outpatient department, and that will help boost Endoform sales. A great opportunity for Symphony. It's not realised yet, but the pieces are coming together here to begin to commercialise Symphony next year.
What are the advantages of Symphony? It is particularly focused on hard-to-heal wounds. This is typically in patients that are compromised in their healing. They have a suboptimal healing response, particularly people with diabetic ulcers and vascular disease. Symphony helps these wounds progress into closure. It includes our AROAa ECM, but also hyaluronic acid, which is known to work synergistically to help increase the speed of wound closure. This will allow us to have a product that can be used at the beginning of healing, the middle of healing, and the end of healing to help speed up healing for these patients. OviTex. What we are seeing with OviTex, again, is compelling clinical evidence. The evidence for OviTex is quite different from what has been seen with this class of product before. Very low rates of recurrence and low rates of explantation.
That means that if there's complications, this product does not need to be removed. Typically, you can manage your way through that. We've been expanding the portfolio of our OviTex products. Now we have a product for inguinal hernia, a large-format product for plastic reconstructive surgery focused on breast reconstruction, and then a new family of products based on a long-term resorbable polymer that lasts significantly longer than the PGA polymer that we initially launched with. There will be three versions of OviTex: a short-acting polymer, a long-acting polymer, and a version with polypropylene. What we expect over time is that the long-term resorbable version of this will become the predominant version that's used. That's really a response to the changes in the market, people moving away from long-term polymers and being more interested in resorbable polymers and hernia.
We did see headwinds last year with sales of OviTex. We think many of the challenges there are being addressed. What we do know about OviTex is that the clinical results are outstanding. We think there is a strong future for this product over the next few years. As that evidence develops, we continue to see this doing very well. In terms of TELA Bio revenue, we have had a couple of setbacks over the last couple of years in terms of guidance and reaching revenue targets for TELA Bio. This year, we have conservatively estimated the rate of growth of our TELA Bio side of our business to take that into account. I just want to focus a little bit on what is our strategy. If you think about the markets that we are addressing, we are focused on complex wounds and soft tissue reconstruction.
In complex wounds, we're focused on Symphony, which is a skin substitute product, and the use of Endoform. In the soft tissue reconstruction market, we're focused on Myriad for large complex wounds and lower limb salvage. Aroa has set up its direct sales team to address that market. We have our partnership with TELA Bio focused on hernia and abdominal wall repair and breast surgery. TELA is focused on inpatient procedures with general surgeons. We're focused on Myriad with a range of different surgeons: general surgeons, plastic surgeons, trauma surgeons, colorectal surgeons. Quite a mix there. We're really honing down where we're putting our effort over the next 12-24 months. As I said previously, the real opportunity is in trauma and lower limb salvage. We're laser-focused on succeeding in this area.
We're directing our Myriad sales team to focus on this tightly. We think there's a large opportunity here for us to gain a large share of this market. In terms of our product strategy, we started simply, and we've progressed to more complex products. Endoform and Symphony for chronic wounds, hernia and breast with our OviTex reinforced tissue matrix, and then soft tissue reconstruction with Myriad. Looking forward, we think there's an opportunity really to improve the rate of healing and decrease complications beyond what's achievable today. That's really been the concept behind the development of Enivo. We see Enivo being very complementary with our Myriad product, potentially complementary with hernia and breast reconstruction products as well, and changing the quality of healing and the rate of healing in these procedures to deliver better outcomes for patients and fewer complications.
We think we can dramatically change what's happening in many of these procedures. We are very committed to Enivo and very committed to progressing that through the regulatory process. We are, at the moment, undertaking a pre-clinical study with Enivo to set ourselves up for a clinical study over the next 12-36 months. We believe that, based on our discussions with the FDA, that will lead to the clearance of this product and the commercialisation of it. What we are trying to do here is build a system of healing that really changes outcomes dramatically from what's able to be achieved today. Moving to the outlook. Guidance for next year is $92 million-$100 million. That is a 10%-20% growth. Myriad will grow in excess of 25%, and OviTex predominantly makes up the difference. Normalised EBITDA of $5 million-$8 million.
Our focus for the next 12 months is large complex wounds and lower limb salvage. Our Myriad value proposition is changing. If you look back 12, 24 months, a lot of the Myriad story was really focused on the fundamental science of the technology and how that improved healing. What we are now seeing is two things. We can clearly show clinical differentiation and improved clinical outcomes with Myriad compared to alternative technology. There is a big change there in terms of how we can talk to surgeons. We are also able to show the difference in cost that Myriad can bring to hospitals or cost savings that Myriad can bring to hospitals compared to what they are currently doing. We have been able to model that out and clearly demonstrate that to hospitals.
Our messaging is shifting very much to the clinical outcomes that we can deliver based on good, solid, prospective clinical data and the value that we can bring to hospitals based on our modelling of hospital costs. We are focused on deeper penetration into accounts. We have started getting into hospitals, having some success in these specialties with complex wounds and limb salvage. We are working on more surgeons using our technology and then, over time, more specialties using our technology as well. We are beginning to see improvements in that account penetration as well. We are focused on a faster sales ramp and increasing the individual productivity of salespeople. As we bring on new salespeople, we want to see that they can make sales quicker and they can be productive quicker. We have done a lot of work around that over the last 12 months.
We've put in place or we're putting in place training. We now have a U.S.-based trainer putting in place a marketing resource in the U.S. to help support the sales team and ramping up our infrastructure there so that we can improve the overall performance of our commercial organization. We're also focused on widening use within hospital systems. We've had success in individual hospitals. We now want to propagate that through multiple hospitals within hospital systems. We're having some very good discussions with IDNs about the potential for our technology to become the standard within their system. Very interesting opportunity there. I think we're going to make some big progress on this over the next 12 months. Looking forward to next financial year, I think we continue to be focused on demonstrating Myriad's distinctive value.
There'll be some studies coming down the line to support this. A large trauma study. This is prospective data. Probably like our lower limb salvage study, one of the largest studies that would have been conducted in the literature in trauma. A pilonidal sinus disease study focused on the use of Myriad implanted in interpilonidal sinuses. That's a great publication coming through with some great economic data in it as well. An initial study in burns of indeterminate thickness. We think these studies will be key over the next 12 months to helping us increase sales with Myriad. Securing Symphony reimbursement in the physician office is a key milestone. The Symphony RCT is an important element of that. The completion of the RCT and then the approval of reimbursements for Symphony in the physician's office is going to be important as well.
Finally, converting one IDN to Myriad across multiple hospitals. We see this as a big opportunity for Myriad. Getting one of the major IDNs across the line will provide an exemplar for other IDNs. A big opportunity there too. I'm going to stop there, Sarah, and pass it back to you.
Thanks, Brian. Right. We've got some questions here from Roshan Rao, who's on the call. Firstly, well done on managing costs and achieving profit. How sustainable is the cost management and sales productivity for the next couple of years?
Yeah, thanks, Roshan. Look, again, as we sort of look forward, and I've said in the past, as we look at our investment in, I guess, clinical development and R&D, that remains a relatively fixed cost. Again, we should continue to see that reduce its percentage of sales.
If we look at our investment in sales and marketing, as Brian mentioned, I mean, key focus as it was in the last 12 months, and you saw those sales metrics play out and improve, is around increasing sales productivity. So I mean, we should continue to generate more profitability. I mean, there is one sort of setback in profit this year. I mean, it does account for tariffs. I mean, we have tariffs of about $1.5 million factored in the bottom-line guidance. Other than that, we should continue to see profitability increase.
Yeah, maybe just add a comment to that too. I think we are focused on high growth and profitable growth. We do not see ourselves compromising profitability. I think we have been measured in expanding our sales footprint. We have got to 50 or so reps.
I think at that stage, we've said, "Look, before we keep on expanding, we want to be sure that when we're bringing people on, that they can ramp up quickly and become break-even and then push on to be able to contribute." I think getting things right before we ramp up the sales of the organization is important. I think, as James said, we're making good progress on that. I think we can grow top-line and profitability in tandem over the next few years.
Great. We've also got another question there from Roshan. Could you comment on the competition product pipeline versus Aroa product pipeline, specifically any products that have a similar clinical outcome?
Yeah, look, I think we're kind of surprised by what we're seeing in terms of Myriad. There's a couple of things that have surprised us.
We're seeing great clinical outcomes. There's some differences with what Myriad does compared to products that are in the market or products that we think may come into the market. What we're seeing there is it is able to regenerate tissue very well. What you often see in the large complex wounds that we're focused in is large soft tissue defects that take a long time to fill. With Myriad, we see that response very quickly, and we can fill the wound up to the level of the skin within 30 days. The other thing we see is that we don't get the level of complications, particularly infection, but also graft loss that's seen with other products. We can do it with a single application. We don't see other products in the market that are able to achieve those three things.
If you layer onto that, the fact that we're bringing this technology to the market in a disruptive way in terms of the cost of the product, but also what it can do for the hospitals in terms of getting people out quicker and saving them a lot of the operating challenges that they have, there's really nothing in the market that can do that. I think a year ago, we didn't have the evidence of that. What we're beginning to see, and we saw in the lower limb study, and we're beginning to see in other studies, is that we have a very distinctive value proposition that we think is going to be hard for other competitors to replicate.
Great. We've now got Elyse Shapiro, who would like to ask her questions live.
I'm just going to send an unmute prompt to you now, Elyse.
Thanks, guys. Yeah, just a quick question around kind of the composition of the sales guidance. How are you thinking about the growth split between kind of Myriad sales and TELA sales? Thanks.
Yeah, no, that's a good question. I think as Brian sort of alluded to earlier, I mean, we see most of the growth coming from Myriad. So an excess of 25% on growth in Myriad. I mean, if we look to TELA Bio, look, we are very confident that TELA Bio is going to continue to perform and get close to achieve their guidance. I mean, just as Brian sort of mentioned, I mean, we have probably kept TELA relatively flat, probably up to about 10% growth.
That is really because in the last couple of years, I mean, we have had setbacks where they have not achieved their own guidance. We are just mindful about that. We want to start the year. We do not want to come out and change our guidance. We want to put something that we are very confident at hitting and monitor that during the year.
Got it. That is helpful. Thanks. Then just on, you kind of mentioned the R&D spend, but just maybe kind of delving into that a little bit. How much flex do you have on R&D cost as it relates to Enivo? Because obviously, that could have a pretty big impact on the bottom line. Thanks.
Yeah, maybe I will talk about Enivo at the end, James. Yeah, so the investment in Enivo this year is into a pre-clinical study predominantly.
That's really setting ourselves up for the clinical study. We are committed to that pre-clinical study this year. We may be able to start the clinical study earlier. That would depend a little bit on the outcomes of the pre-clinical and how we're tracking in terms of clinical expenses as well. There is opportunity potentially to push that out into next year. Can you add something to that?
Look, I mean, yeah, there's certainly flexibility in the R&D. I mean, and again, we sort of use that flex based on our sales performance. I think we're sort of seeing that during this last year where our total R&D spend actually decreased, although a slight increase in the expense portion. There certainly is some flexibility.
Yeah, I mean, one other thing on Enivo, most of the product development is done.
We're not spending money on developing product. It's really on meeting the requirements for FDA clearance. That's where the—and that's clinical and pre-clinical work.
Got it. That's helpful. I mean, are there any other contributors to that R&D spend line, or is it mostly Enivo and probably what's a bit of Symphony?
Absolutely. So Enivo is obviously a key factor to that. I mean, look, we're continuing to innovate and work collaboratively with TELA Bio and expanding their portfolio. There's a fairly large active project with them on that. We continue to also look at line extensions and process improvements that extend our Myriad portfolio and also sort of add to continuing to increase manufacturing efficiencies.
Thank you.
Okay. Just also following on with Enivo, I've got a question here. How much are you expecting the clinical trial to cost?
Can you confirm that the expectation is it could be three years before launch of that product?
Yeah. Look, I mean, that's our base case. We won't really know until we complete the pre-clinical study. But we'd expect it to be—I mean, we run a clinical study. It's typically a 12-24 month process. This year, if we focus on the pre-clinical study, then next year, 12-24 months, it's within 36 months that we'll complete that. I think cost's still to be determined.
Okay. We've also got some interest on the impact of U.S. tariffs. If you could comment on that.
Absolutely. As I mentioned earlier, I mean, the impact of tariffs is about $1.5 million. It's not the full 10%.
That is really the reason for that, is essentially the arrangements we have in place with both TELA Bio and our own internal U.S. entity and the fact that we're charging them a certain transfer price, which is declared at the border. If you think about it, it's probably about 1.5%, the impact on 1% of revenue.
Okay. We've got some pre-submitted questions that were emailed from Brad Selkirk. He'd like to know what your view is around the share price since listing and what you expect for growth ahead and how you expect that will impact on the share price.
Yeah. Look, I mean, obviously, the share price has declined since listing. I think where it sits now, I'm not sure that that really reflects the true value in the company. From a company perspective, year on year, the company's growing.
We've built out the evidence behind the product. We've built out the maturity of the sales organization. I don't see this as a linear process. I think we're beginning to get the foundations come in place to really accelerate what we're doing. I think there's been some drag on the share price due to some of the uncertainty around the sales of OviTex, particularly over the last two years. I think in that respect, what we're seeing is good evidence for the OviTex product. We think it's a very—it will be a successful product over time. TELA Bio, we see them—our base case is that they continue to trade through, and they're successful. Now, if that doesn't happen, we think we're well placed with other potential scenarios there. I think we're at a point in time.
I think there's a disconnection between share price and what the company will deliver. That's what we're focused on, is correcting that.
Okay. We also have a question here around explaining what an IDN is.
Yeah. An IDN is a hospital system or a system of healthcare delivery to patients. What you tend to see in the U.S. is that hospitals are owned by corporate owners. Those owners tend to do similar things across all of their systems. For us, an IDN is helpful in that if we have good results within one or two hospitals, then there's an opportunity to standardize the use of that product across multiple hospitals.
That is part of our strategy: show that products like Myriad work very successfully, and then work on increasing their use and standardizing their use at a hospital level, but also doing it across a whole hospital system. It is a way to accelerate growth, but also becomes a really important validation event for the technology generally. If you start to see products being standardized at an IDN level, that is a good indicator for other hospital systems that there is merit in what you are doing.
Okay. Thank you. We have another question from Roshan Rao. What is the estimated market penetration of the Myriad range in the U.S. market currently? Within an existing account, is there more depth and width to sales opportunities?
Yeah. Look, we are less than 5% penetrated in the markets that we are targeting.
There's definitely—I think we're scratching the surface of the opportunity in the accounts that we're in at the moment. A lot of opportunity to gain more share. Part of that is the natural conservative nature of surgeons in that they'll use a product to a limited extent to start with, to gain familiarity, to see clinical outcomes in their own hands, over time develop confidence, and then use it more frequently and more widely. I think we're now progressing through that stage where surgeons have confidence to use our technology. They've seen it work in their own hands. They're seeing the clinical data to support its use. I think that's going to drive deeper penetration within accounts.
Okay. There's a comment here around at the quarterly presentation, you mentioned a reduction in administrative effort required to reimburse Myriad.
If you could talk a little bit more about that. I think that might be relating to the hospital outpatient codes.
Yeah. We have codes now for Myriad in the outpatient setting, or even if it's used in the inpatient setting. It's a way to—firstly, it provides you a way to track the usage of your product in hospitals. It also gives you an option to claim reimbursement for the product cost in some outpatient settings rather than use a general code. For some settings like ambulatory surgical centers, which are like day surgery centers, this now gives them a way to associate a procedure with a specific product and therefore gain a payment for it.
Right. Susan Robinson would like to know whether the current U.S. FDA staff changes are impacting the length of time to get approvals on clinical trials.
Yeah, that's a good question. Look, we've got some things with the FDA at the moment. My understanding is of the review process that we've been going through, it hasn't been any more onerous than we typically expect. I mean, obviously, if their staff numbers decrease, that could just increase the time that it takes for products to be cleared. At this stage, we're not seeing any difference.
Right. Okay. We don't have any more open questions. I'll just leave it a few more moments to see if another few come through before we conclude. Okay. I think that concludes the questions. I'll just hand over to you, Brian, to just wrap up.
Great. Thanks, Sarah.
Look, we're pleased that we've been able to deliver the result that we did based on the updated guidance, both being good growth on the top line, but EBITDA positive and cash flow positive in the second half of the year. I think we've turned a corner here. We're going to continue to grow the top line, continue to become profitable. We think we've got the fundamental elements coming together to make Aroa very successful over the coming few years. Thank you for your ongoing support. We look forward to some improvements over the next 12 to 24 months.
Great. Thanks, Brian and James, for your presentation. Thank you, everyone, for attending. We will now conclude the webinar.