Okay, thank you for your patience, and we'll kick off now. Welcome to Aroa Biosurgery's Investor Webinar and Q&A, following the company's FY 2024 full year results announced this morning. Please note that participants are in a listen-only mode. There will be a presentation lasting for approximately 30 minutes, followed by Q&A. We will have to finish up by 10:00 A.M. AEST. If you have a question you'd like to submit, please type it in using the Q&A function on the Zoom app. We will also be opening the floor to live questions. If you would like to do that, when the Q&A session commences, please use the Raise Hand function on the Zoom app. Please note that the session is being recorded. On behalf of Aroa today, we have Brian Ward, Founder and CEO, and James Agnew, CFO. I'll now hand over to Brian and James. Please go ahead.
Thank you, Neetha, and thank you, everybody, for joining our full-year results webinar today. I'm gonna provide a brief intro to the company for those shareholders that are new to the company, and then run through our full-year results and a short overview of some of our clinical activities. I'm then gonna hand it over to James, who's gonna talk about some of the detail within our financials for the full year. For those that are new to Aroa, we're a well-established, high-growth soft tissue regeneration company. We have four families of products that we sell predominantly into the U.S., all based on our Aroa ECM platform. The total addressable market for the opportunities that we're targeting in the U.S. is in excess of $3 billion.
We sell through two channels, our own direct sales team, and then also through our commercial partner, TELA Bio. The technology is well established. We've treated over 6 million patients, and there's a large body of scientific and clinical evidence that sits behind our products. We have regulatory approvals in 50 countries. The company is about 270 people. We also have a new technology that we're working on called our Enivo Tissue Acquisition Platform, and I'll talk briefly about that, in the presentation. Essentially, what we do is we isolate a, very thin layer of tissue from the fourth stomach of sheep.
We purify that in a way that removes all of the components that the human body would react against, but retains the structure of that material and the biological molecules, and both of those things act as a scaffold for tissue regeneration. That then becomes the building block for all of our products. So our first product that we launched was a product called Endoform for diabetic ulcers and venous ulcers, a simple single sheet of this material, and then progressively, we've moved on to more complex products for more complex applications. So Myriad is our soft tissue reconstruction product, a multilayer version of Aroa ECM. Symphony combines Aroa ECM material with hyaluronic acid for very difficult-to-heal wounds, predominantly in people with diabetic and venous ulcers.
OviTex is a product that combines Aroa ECM material with synthetic polymers designed to be used in applications where there's a high load on the implant, and therefore it needs structural reinforcement with those synthetic polymers. There's two versions of that product, a version that's used in hernia that has either permanent or synthetic fibers, and then also a version that's designed for soft tissue reconstruction, particularly for use in breast reconstruction. In terms of financial results for the last financial year, FY 2024, total revenue of $69.1 million against guidance of $67 million-$70 million, and product revenue of $68 million.
Product gross margin 85%, consistent with guidance, and a normalized EBITDA loss of negative $3.1 million against guidance of $3 million, $1 million-$3 million. We ended the year in strong position with a cash balance of $29.5 million. In terms of sales, you know, some challenging times and successes this year as well, so relatively modest growth, 12% year-on-year. If you break that down and look at where those sales results come from, you know, we're very pleased with Myriad sales growth, so 73% year-on-year growth. So good growth there, through our own direct sales team. OviTex was, for us, you know, we went back this year, so negative 7% year-on-year.
So despite TELA Bio sales, who's our commercial partner, for those products growing at over 40%, we went back 7%, and that was really due to some inventory adjustments, which were one-off over the last year. And we expect that to come right and for our sales to come in line with theirs, over the coming year, and James will talk about that in his section of the presentation. Endoform sales flat through the course of the year, which was in line with expectations. In terms of sales expansion, you know, we continue to see, you know, along with that 70% growth in Myriad, expansion to the number of active accounts as well, so a 31% increase year-on-year in the number of active accounts.
We've also increased our sales team over the last year, adding 10 people, so moving from 48 to now a team of 58 in total. So that's 50 field reps, and then 8 inside sales reps. Just in terms of the opportunity and market potential of the markets that we're operating in, I just wanna talk a little bit more about the details in there, and the growth opportunity for Aroa. So most of our effort's going into our Myriad products. We're targeting soft tissue reconstruction procedures within the operating room. If you look at the number of procedures in the U.S. per year, there's over 420,000 procedures where Myriad would be an option to be used in those procedures.
So we believe this represents an opportunity of over $730 million, and there's two big segments of this market. So lower limb salvage procedures, 180,000 of these procedures being done inpatient in the operating room. We believe that's an opportunity of about $225 million. And then there's the traumatic wound procedures, where there's 90,000 of these procedures which would be relevant for Myriad, so we believe that represents an opportunity of $300 million. So if you look at where we're putting our effort, these are the two largest areas that we're targeting. We have also been selling Myriad into other procedures, and I'll talk a little bit about that when we talk about clinical evidence.
But most of our effort is in lower limb and traumatic wounds, and what we've seen happen over the last 12 months is, we're now beginning to do many more procedures within trauma centers. So there's been a shift over the last 12 months from doing a lot of lower limb salvage procedures to many more trauma wounds. The difference between those two procedures is that the lower limb salvage procedures tend to be high volume, but lower in value, whereas the trauma wounds tend to be relatively low volume, but very high in value.
What really differentiates us in these markets is the rapid volumetric fill that our product, Myriad, provides, its persistence in these wounds, which means that it's providing a framework for tissue regeneration for longer, and also the disruptive value that we can bring to this market. And when I talk about disruptive value, there's a couple of factors. One is that the rate of healing changes the economics of healing for the hospital. It means that they can get patients out quicker, so it reduces their cost. But also what we find with Myriad is that it needs fewer applications, and so we're reducing the number of procedures that patients require, and therefore hospitals require as well. And also, our pricing is typically more affordable than some of the market-leading products.
So we believe there's a very strong value proposition for our products within these soft tissue reconstruction procedures happening within the operating room. We've also seen a lot of these procedures in soft tissue reconstruction be combined with negative pressure wound therapy, and we believe there's a very large opportunity for Myriad to be used in combination with this technology. There's over 1 million of these procedures done per annum, and we believe that with Myriad in combination with negative pressure wound healing we can accelerate the rate of healing, reduce the number of interventions, and reduce pain for patients, and also reduce the number of negative pressure wound applications. So I think there's a fantastic opportunity to build really a new opportunity for Myriad within this market.
And then, we're also targeting lower limb outpatient procedures in wound centers, and so these are procedures where patients have very poor healing responses and require products that really help them heal these difficult to heal wounds like diabetic ulcers and venous ulcers. There's over 475,000 of these procedures performed per year, and this represents an opportunity of over $1 billion per year in the U.S. The benefits that we bring to the market with our products is that we believe we can widen patient access to advanced biologics and increase the rate and quality of healing of these wounds. So again, a large opportunity.
If you look at across all of these, applications and our level of sales, we're really only scratching the surface in terms of, the penetration that we've achieved to date, and what we're able to do in the future. So I want to talk a little bit about, our investment in clinical evidence. So over the last two or three years, we've made some quite significant investments in clinical evidence. We will be increasing those investments over, the next couple of years, and I want to talk a little bit about why we're doing it and where we're focusing. So there's a number of reasons why we're investing in clinical evidence.
I think what's important at the outset is that surgeons want to know that your products are effective for specific procedures, and this can be doing relatively small number of cases and showing that your product is successful in healing patients with those specific procedures. It's also very important to be able to determine the comparative efficacy of your product versus alternate products or the standard of care. And what I mean by that is they really wanna see is your product better than what they're doing now? Clinical evidence is important in terms of showing that your products can save the hospitals money. It's important in terms of showing that your product can potentially be used for new procedures or new uses.
From a sales perspective, it's very helpful in that it's clinicians and surgeons find clinical research engaging, and it's very useful in terms of elevating your share of voice within the market. Once we have the data that comes from this clinical research, it also helps us go out and promote our products and show the comparative difference of our products versus alternate uses. And then finally, it's really important in terms of informing our commercial strategy and allowing us to focus on areas where we have advantages over existing standards of care or other products. So it's you know, we make big investments in this area, and it does help us to be able to promote our products. But also, these investments have a payoff over multiple years in the future.
So if we look at where we've got to now, you know, we have a large body of, clinical evidence that's, been established based on our existing products, and a large number of publications and presentations. We see three themes that drop out of this. So firstly, this rapid, volumetric fill of these soft tissue, deficits that's well vascularized, functional tissue. So that's, you know, quite a differentiator compared to, alternate offerings. Our products are also tolerated, very well within contaminated fields, and we don't see, high levels of infection, which is unusual for biologic products. And then thirdly, we don't see, negative inflammatory responses, with our product.
So I want to talk a little bit about where we're focusing, in terms of our clinical research and how this aligns with our target, you know, the area, the market segments that we're targeting. So if you look at trauma, you know, trauma is certainly a big focus for us now. If you look back at the publications and, you know, the confidence that we have that, our products make a difference in trauma, you know, it's based on our clinical experience, but it's also based on some preliminary data from, early publications that we've had. So the use of Myriad in combination with exposed structures, use of Myriad in procedures where there's exposed structures, use in trauma, use in open abdomen.
So based on our success to date in trauma, we're really now focusing on significantly larger studies and setting ourselves up to have a strong body of evidence in trauma. So over the coming year, we have two important studies that will be published, so Myriad in combination with negative pressure, this comes out of our master registry. It'll be 40-50 patients, and this is a prospective study, and some of those patients will be trauma patients. We also expect to produce a 40-50-patient study from the Marsh Master study, solely focused on trauma, that will be in Q4. And then we're setting ourselves up for RCTs with exposed structure, where we're using Myriad in combination with negative pressure.
So initially a pilot study of 20, and then that will lead into a much larger, randomized controlled trial of somewhere between 50 and 80 patients. So, you know, I think what's happening in trauma is our confidence in the opportunity there is has been strengthened and, you know, the differentiation of our product versus alternatives, and we believe we're in a very strong position. So we're now seeking to generate the evidence to a strong body of evidence to help drive our success and accelerate our success, our selling success, in these areas. In lower extremities, we, you know, we have both from Endoform and Myriad, some quite good, existing data. We have a prospective or a large prospective study, that will be published this year on limb salvage.
With Myriad, that's 130 patients. That will probably be one of the largest published studies in limb salvage. So that's expected out in Q1. And then we are halfway through a randomized controlled trial with Symphony at 60 patients, and then they'll have a full readout in the first quarter of Q1 in FY 2026. So this is really important for Symphony in terms of both establishing the evidence, but also in terms of reimbursement for Symphony going forward in the outpatient wound center. So I think on the lower extremity side of the business, we're good—developing a very compelling body of evidence that we believe will help accelerate sales there. And then we have a number of other studies in colorectal.
We're doing this more for the sake of gaining access into hospitals. They're relatively small procedure numbers, but they do help us initially get access to hospitals. But also some of these procedures are extremely challenging to heal, so they help to demonstrate the benefits of Myriad in healing generally. And similarly in general surgery, you know, with very challenging wounds that we're healing here, and some nice data coming through on pressure injuries. A 40-60 patient study there during the second half of this year. So if you look at that as a whole, you know, we're beginning to see a lot of data come through to support the sales of both Myriad and Symphony for the future.
We see this as a really, an important catalyst for the future to drive sales traction, and provide evidence, but also provide the financial benefits to hospitals of using our products. In terms of OviTex, you know, TELA continues to make good progress with OviTex. They've grown by over 40% over the last year. Most of the... Well, the products have really been selling across the variety of different types of hernias. So, if you recall, we initially started off on the more complex end of hernias, so complex and moderate hernias, then progressed into simple hernias, inguinal hernias, and hiatal hernias.
We now have a very broad portfolio, so, with the launch of the inguinal hernia product very recently, you know, we believe that the TELA portfolio is very well placed to succeed and continue to gain momentum. So that's a large opportunity in excess of $1.5 billion in the U.S. We're certainly seeing continued strong growth from TELA. And particularly with the move towards robotic surgery, and we're seeing the inguinal product and some of the simple ventral products be ideally suited for use in those procedures. On the breast side, or on the plastic surgery side, we're seeing, you know, strong growth with the OviTex PRS product.
This year, we've launched a second generation product for that market with a new polymer, and we're very excited about the growth in that product over the last 6-12 months. In terms of Enivo, you know, this is a new technology that we've been working on for some time. You know, we believe this presents a large opportunity for us in the future. It's a novel device, and we think this will create a whole new category of product. You know, based on our estimates internally, we believe the TAM for this is in excess of $1 billion. To date, we have the pump and the catheter system cleared by the FDA.
There's a third component, an envelope or a matrix component, that needs to be cleared, and there's further preclinical clinical studies required for that clearance. So, you know, we're in a dialogue with the FDA on the, on the requirements for that. You know, we do expect that, you know, that's probably, you know, in the 12-36 month time period, that product will be cleared. Based on our research to date, you know, the preclinical model demonstrates, almost, complete dead space closure. So we think, this addresses a major problem that's not solved, by any other procedure. And we've recently completed a pilot study in mastectomy, which is fully recruited, and we're just, going through the data analysis with that. But, the initial, look at that data looks very positive.
The great thing about this product is that it fits with our existing call point, our existing sales team, so it will be complementary to them. And we see this being sold in combination with our existing products. A great product to engage with surgeons and certainly, you know, help create conversations and engagement with Aroa as a whole. We also believe this product, you know, has opportunities outside of where our existing sales team can sell, so, you know, potentially opportunities for us to out-license this product into other specialties or other market segments. It also has a strong strategic alliance with our move into Myriad in combination with negative pressure. So, you know, a product that we think has got a lot of utility across the whole business.
So I'm now gonna pass it over to James, and he's gonna talk through some of the details in our financial results.
Thanks, Brian. So what I'd like to do is just present the financial results of the book when broken down. As Brian mentioned earlier, total revenue for the year was NZD 69.1 million, of which product revenue accounted for NZD 68 million. In respect, essentially was growth of 12% on year, so fairly modest, but really held back by you know, the sales in the first half, okay? And predominantly TELA Bio sales to TELA Bio. So looking at the second half, there was a big step up in, there was a big step up in revenue, driven by two factors.
Myriad continued to grow, growing 30% on H1, and TELA grew 19% on H1, reflecting, you know, our sales to TELA realigning with TELA's sales trajectory. Product gross margin continued to improve. Total for the year was 85%. We reached 86% in the second half. So it was sort of held back a little bit in that first half by the lower sales volumes. Normalized EBITDA improved in the second half, despite the higher than anticipated investment into the clinical Symphony clinical study, which was a result of patient recruitment, you know, tracking ahead of plan. So ending the year with a normalized EBITDA loss of NZD 3 million.
Just sort of talking more about the TELA situation. So, as Brian mentioned, TELA's sales, which are represented in this dark gray line, continued to grow very strongly. So growing in excess of 40% in the calendar year 2024. But then what we've seen during our FY 2024 year, as highlighted in the orange line, is that our sales actually reduced by, well, by 7% for the year. Now, that was solely the result of in the first half, particularly in the first half of the year, TELA undertook, you know, quite active management of its inventory position, managing that inventory down to a much more effective level.
And so their inventory reduced from 33% of revenue down to 22% at the end of the year. We're obviously confident that, you know, TELA probably during the second half, reached a position where the sort of inventory levels had reached their sort of minimum levels and now can see that sales are tracking back in line with their trajectory. Looking at manufacturing, sort of touched on it earlier, we continued to improve gross margin. That's a result of, you know, the increasing sales from the higher margin Myriad products, but also supported by ongoing improvements to manufacturing efficiencies. Manufacturing capacity, you know, at the end of the year, still remains about NZD 150 million in revenue.
That will increase within the next six months to NZD 200 million as a result of the final, you know, our final investment in our tissue processing facility coming online. Capital expenditure for manufacturing, you know, there was a large investment in the previous year, reflecting obviously, you know, the increase in capacity to NZD 150 million. That reduced in FY 2024 and will continue probably at that level just for the next year, as we invest or finalize the investment in that tissue capacity. In terms of use of funds, you know, sort of highlighting here with sales and marketing, we continue to make, you know, a large investment in growing our U.S. commercial operations.
Sales and marketing expenses increased from about NZD 30 million to NZD 40 million, and just under NZD 40 million. And this was really the result of three factors. One was the annualization of the additional head count that we'd taken on in FY 2023. It was, you know, an additional 10 salespeople that we brought on in FY 2024, but also an increase in the variable compensation linked to obviously the higher or strong sales growth of Myriad. R&D, our spend in R&D remained relatively flat to FY 2023, and that was really driven by sort of the investment, you know, the decreased investment in Enivo during the year.
Clinical expenses, as Brian mentioned earlier, sort of our investment in clinical, you know, increased from $3 million to $6.6 million, and that was really representative of the investment during the year into the Symphony clinical study, which was a total of $3.6 million during the year. And then cash on hand, look, we ended up with a very strong cash position of just under $13 million dollars. With obviously, you know, the expectation that we're cash flow positive in the next 12 months. And I think, you know, look, again, look, we continue to obviously invest in the Enivo platform. In the absence of that Enivo investment, we would obviously be, we would be profitable. With that, I'll hand it over to Brian.
Great. Thanks, James.
... So looking forward to next year, guidance is for revenue $80 million-$87 million. So that would represent a 21%-32% increase on the current year. And we expect to be profitable, so the normalized EBITDA of $2 million-$6 million. In terms of catalysts and milestones for next year, you know, we expect to see continued strong growth for Aroa. You know, return for TELA Bio to have, you know, strong growth for them over the coming year. Enivo, FDA clearance, making progress on that. We don't expect it to be cleared in the next year, but we think, you know, we will be making progress towards clearance with that.
Symphony, completion of the RCT, and, you know, potentially some, some changes, in reimbursement, where that RCT will be, extremely helpful. And then making progress with trauma and limb salvage evidence. So, you know, the delivery of these clinical studies coming through, and that providing, tools for our sales team to continue to promote, Myriad, in these areas and, accelerate their success. So with that, Neetha, I'll pass it back to you for, questions. Thank you.
Thank you, Brian and James. We will now move on to the Q&A session. As I mentioned at the start, please use the raise hand function on the Zoom app if you would like to ask a question live. You can otherwise type your questions in using the Q&A function. We will start with some live questions. If you are asking a question live, I will send you an unmute prompt, which you will need to accept. Please introduce yourself before asking your question. We will give you the opportunity to ask a follow-up question if required. To facilitate this, you will remain unmuted whilst your question is being answered. The first question I have is from Elyse Shapiro. Elyse, please go ahead.
Hi, it's Elyse Shapiro from Canaccord. Just... Sorry, I'm getting some feedback. Just wondering, looking into the guidance, what are you assuming for Symphony there?
Very modest growth over the coming year, so less than $2 million in sales. You know, we think that we're going through a pilot with our sales team to set ourselves up for that. You know, we don't see that gaining full traction over the next 12 months. But following on from that, we do see Symphony starting to be pretty meaningful in terms of contribution to sales. You know, the reimbursement landscape in that area remains uncertain, but certainly some strong signals of some changes happening there.
Got it. And just on the sales force as well, what are the hiring plans for that for the next year or so?
Yeah. So, I think, we know, depending on, you know, how we're tracking in terms of sales productivity, we probably won't add anyone in the first six months, but the second six months, you know, potential to add 5-10 field sales representatives.
Got it. Thank you.
The next question I have is from Rob Casson. Rob, please go ahead.
Yeah. You can hear me okay?
Yes.
Yes.
Thank you.
Thank you. James, I know it's a little bit of an elephant in the room question, but clearly the share price hasn't performed particularly well in the last 12 months. You are growing, you're getting closer to a positive cashflow. Why do you think that is, and where do you see it going in the future? Difficult question, I know.
Yeah, I mean, look, it's, Robert, it's incredibly frustrating. We continue to sort of scratch our heads. You know, I look, you know, part of us sort of thinks we're in this sort of market where, you know, it's, you know, it's, it's we can't control, it's market related. But I think, you know, look, I think there's some sort of key critical sort of milestones over the, the next sort of 6-12 months for us, is that we can prove sort of pro- profitability and, you know, positive cashflow and, you know, hit the upper end of guidance. I think it's, it's a different playing field for the, for the share price. I mean, that's my view.
Yeah-
Yeah, I mean, the one thing... I'd just add one thing to that as well. We did downgrade our guidance mid-year, and I think that didn't help, and, you know, partly affected by, you know, we expected TELA to be a little bit stronger. So, you know, I think if we can execute on the sales side, TELA comes back, people see our sales coming into line with TELA, and we maintain strong growth, then I think, you know, we'll be back in favor. So I think, you know, the underlying fundamentals are there. We've just got to deliver on the growth side with sales.
Can you still hear me?
Yes, we can.
Yes.
Thank you.
The other thing I might just suggest to you, there's not that many brokers that talk much about ARX, so possibly, I'm not sure exactly who covers us, but you don't—I read a lot of stuff and do a lot of investing, and you don't see ARX mentioned very much, so possibly it may be worthwhile trying to get a bit more coverage with a few of these guys.
Great. Thanks for the feedback.
Okay, the next question I have is from Madeleine Williams. Madeleine, please go ahead.
... Hi, Brian. Hi, James. I just wanted to ask a question. I mean, you touched on it a little bit, in regards to guidance for FY 2025. I think just understanding, obviously, the OviTex, your sort of reliance on TELA there and driving growth, but maybe how you're thinking about, you know, the guidance that you provided and the range when you can kind of get confidence in what you're looking at with Myriad. Is it sort of the account productivity, sales rep productivity, and how you're kind of tracking that throughout the year?
Yeah, I think we've looked at guidance this year of obviously, you know, we don't want to be in a situation like this year, where we made a downgrade through the middle of the year. So put some numbers out there that we feel confident about. The range is quite wide, and I think as we go through the year, you know, there's an opportunity probably to narrow that up a little bit. So, you know, we're starting with something that we think is absolutely achievable. We'll change it over time. You know, we're confident about TELA coming back. Obviously, we want to see that. You know, we've had good ongoing growth from Myriad, and obviously, we want to see that continue to track through into the coming year. But anything to add? Yeah.
Okay. Thank you.
Thank you, Madeleine. I have a question around the issue in the U.S. to overcome provider resistance to change, and the question is around what Aroa is doing to overcome that. Clinical evidence is obviously one aspect, but are there any other initiatives that we are going to be addressing around, say, health economics, as an example?
Yeah, it's a great question. Look, I think we're focused on a few things. So, clinical evidence is important to get clinicians on board and get advocates, you know, clinical advocates for making that change within the hospital systems. You know, I do think financial evidence that your products make a difference for hospitals is critically important. That can be built off the back of clinical evidence, so, you know, deriving a good business case off the back of that to show hospitals that your products make a real difference. We're putting a lot more emphasis on that, and I think, you know, over the next couple of years, we'll really start to broaden out that picture.
So I think that's important for our products, particularly because, you know, not only are we making a big difference for patients, but we're also got a very good story for hospitals as well. And, you know, with the significant value that we bring to hospitals, I think that gives us the opportunity to increase our velocity of success within those hospitals, but also to be much more anchored within those hospitals because the financial case is so strong. So it is something that we're turning our minds to a lot more and starting to build out that base of evidence a lot more.
Thank you, Brian. There is an associated question, given that insurers are a dominant, dominant funder in the U.S. market, and the question is around whether we are, you know, whether we engage with insurers as well.
Yeah, within the procedure it depends on... We're not, because most of the procedures that we're covering within the hospitals are paid, there's reimbursement to the hospitals under a fixed fee DRG code. So it's a lump sum payment for a particular surgery, and the hospitals are making the decisions around the products that they use in those procedures, and so we're well placed for that. In some of the outpatient procedures, particularly in the outpatient wound centers, they do have an influence for the younger patient population. So I think going forward, that may be something, an area that we put more emphasis. But short term, you know, we're in a pretty strong position without necessarily having payers on board.
Thank you. And sort of a final question on that theme of conversion and change. Do you have any final comments on the competitive environment generally?
Look, I think we're in a, we're in a good position. I think we've got a very unique offering, and, you know, that we're beginning to build out based on the differentiation of our products, the clinical evidence that we're accumulating, and as we just talked about, you know, as we start to build the business case and the financial evidence for what we're doing. So I think we're uniquely positioned. We don't see, with the existing, competitor set, other companies being able to replicate that. And I think if we look at, you know, potential new entrants, into the market, we're not seeing, anything that looks disruptive there. So I think, you know, Aroa's got a very long way to run.
We feel like we're just getting started, and we're beginning to kind of get the fundamentals in place that will, you know, set us up for, for success.
Great. Thank you. So, there's also a question that's come through around, you know, Aroa's obviously chosen to invest internally, including into its U.S. sales and New Zealand staff, and has not yet elected to return a dividend. Is that something you can comment on, please?
Yeah, look, I think we're a bit of a way away from a dividend. I mean, we, we are a growth company, and, we're making this transition now to becoming profitable. And I think, you know, we should be profitable in the next 12 months and be able to track towards being, you know, increasingly profitable in the out years. So,
... Yeah, we do wanna continue to invest in growth, you know, invest in growing our top line. So, you know, I think dividends are probably still a little bit of a way out.
Thanks, Brian. So I've got a question coming back to the two key themes that we've covered. Sort of comparing Aroa to its peers, can you comment on valuation, given corporate activity, and also how competitively priced Aroa's products are compared to our competitors, for example, fish skin?
Yeah, look, I mean, look, I mean, we in terms of the valuation, in terms of the market valuations, I mean, look, there is a big disconnect between Aroa and some of its peers. And look, if you look at the fundamentals of each of, you know, those, the businesses, including Aroa, there is, you know, areas they might be a little bit stronger than Aroa, but there's certainly areas where Aroa is certainly stronger. But, you know, a lot of the fundamentals, you know, there's not too many dissimilarities in terms of the numbers, you know, the fundamental numbers that we're currently producing. So I think, yeah, look, there is a real disconnect. I mean, arguably, that means that there's an opportunity, I guess.
Yeah, I think one of the things, the other thing I'd say is that, you know, if you look at, you know, many, many of our peers that we're compared against, you know, they've been commercial with, you know, with commercial products in the market for considerably longer than Aroa. So we're, you know, we're coming from a little bit further back. We're a little bit more immature in the development of the organization. And probably to date, there's been a lot less capital deployed to get the companies to where they are now. I think on a comparative basis, you know, given the, you know, given the timing, given the capital gone in, we're very well placed.
So I think, you know, you know, we're, we are on a growth trajectory, and I think we'll, we'll deliver on that valuation, over time. There was a question about, Aroa, compared to, I think, other products from a pricing perspective. You know, we're certainly, more competitively priced than some of the market-leading products. I think, you know, specifically, the fish skin product, I mean, you know, a little bit more competitively priced, compared to that product. I think from a performance perspective, I think, you know, we believe that it certainly outperforms, those current products on the market.
Thank you, both. James, this is a question for you, and it's around free cash flow forecast for FY 2025 and what you expect to see regarding cash burn.
Yeah, look, I mean, I think we're very confident that we have positive operating cash flows over the next 12 months. I mean, we've got just the remaining investment, the remainder of the capital expenditure for our tissue capacity expansion. That should finish up in the first half of the year. So that will obviously impact our free cash flows. But I'd certainly like to think that in the second half, we're seeing positive, certainly positive cash flows at the operating level, but potentially also free cash flow positive, you know, in the last quarter.
Thank you, James. There's a question around whether Aroa's products were used in the White Island disaster or in any other sort of any other similar events. You know, does Aroa donate products to incidents like this?
Yeah. It wasn't, they weren't used in the White Island disaster. And the reason, or one of the reasons for that, is that at that stage, we had only just begun to release those products in New Zealand. So we were just a little bit early in terms of where we were in New Zealand. I mean, we have had Aroa products, you know, used throughout the world in different disaster and war zones. So certainly, you know, we've donated product into Ukraine, into some South American countries, I believe, as well. And so, you know, on occasions, we've certainly done that.
Thank you, Brian. There's just a question sort of clarifying, I think, post James's answer about cash flow. You know, just clarifying that Aroa is saying it will be EBITDA positive in 12 months?
Yes. I mean, our guidance, obviously, we've set guidance to be EBITDA positive. You know, we've given guidance to be $2 million-$6 million for the year.
Thank you. There is a question coming back to U.S. sales, because obviously that is key. It's around what Aroa is doing to grow its performance in the U.S., whether it's through increasing the number of hospital accounts, and also what performance initiatives are being put in place to achieve that.
Yeah, certainly, increasing the number of accounts that we're in, we've seen good growth there, over the last 12 months. Increasing our sales productivity, part of that is on a year-on-year basis, having our sales reps, you know, continue to grow and for their territories to mature. We have, you know, a number of initiatives to support that. So certainly, as clinical evidence flows, you know, using that as promotional activities, you know, being very clear about the specific objectives within our accounts in terms of growth....
I think, you know, we are in, if you look at the number of sales reps that we have, field reps, and the number of accounts, you know, initiatives to increase the number of specialties within hospitals where our products are being used as well. And we do, you know, we're active at conferences, we're active in terms of webinars, in terms of, you know, peer-to-peer discussions between some clinicians that we lead. So a lot of it is around using our existing product champions or users within hospitals to help us promote and demonstrate the use of our Myriad products within those hospitals and how that benefits other specialties.
Thank you, Brian. I've got a question here around the capacity expansion that you've mentioned, and if you're able to expand upon, you know, what those measures have involved?
Yeah. We've been building that out over the last couple of years. We built a fabrication facility back in 2020, I believe, that gave us the ability to fabricate devices for the full portfolio up to about $150 million. There was a mismatch with our tissue processing capacity, so we brought that into line. So that's scaling up the processing of tissue that becomes that building block for the devices. So that's now... Well, next year, that will be matched with the fabrication facility. And what we've seen as we've put that capacity in place, we've also made process improvements.
So the capacity that we expected to have, which was $150 million, has now gone to $200 million, because of some efficiencies in how we use that capacity. So, you know, we have to build capacity, you know, at least a couple of years ahead of sales, to make sure that that is in place as we grow into it. So it tends to be built in steps, and that's why we've invested ahead of obviously where we are, currently.
Thank you. There has been a question around TELA's reorder cadence and, you know, whether you've seen a reset coming through since last year.
No, absolutely, and look, we started to see, we started to see that during the second half of FY 2024. That was, you know, a big reason for why we saw a, you know, close to 20% increase in sales to TELA Bio in the second half versus the first half. And look, we continue to see that, you know, based on the forecasts that they're providing us.
Thank you. A slightly different question now is, whether Aroa's investigated the potential benefits of, of AI?
Look, early stages, but, you know, we have looked at a couple of things within the business where AI is particularly helpful within narrow applications based on some of our own kind of proprietary data. But that's probably as much as we can say at this stage. But obviously a really interesting area. Lots of areas within the business that can be applied and, you know, certainly see some great opportunities for AI in the future.
Thank you. A question's come through that's sort of trying to understand the distinction between, sort of free cash flow and breakeven and operating cash flow breakeven, and whether, you know, the guidance is about being operating and cash flow breakeven or free cash flow breakeven.
Yeah. So the guidance, the guidance we're giving is at, a, you know, at a profit level, okay? Now, obviously, at a cash flow level, that's impacted by, obviously, the timing of payments and receipts and, you know, increases in, you know, inventory and your accounts receivable, et cetera. So I mean, look, we intend. I mean, we hope to be, we expect to be cash flow positive definitely in the second half. We may be cash flow positive for the full year.
Thank you, James. Coming back to sort of developing or further expanding, Aroa's corporate profile, there's a question about whether the management has made contact with Sharesies. Apparently, they have a regular web session with CEOs, which would help tell Aroa's story to retail investors.
Yeah. Look, we have engaged with Sharesies, and we've been involved in some of their promotional activities. And we've got a program of ongoing activities in Australia and obviously looking to continue to do more in that area as well.
Thank you. I have a question from... a live question from Brad- Ben Rodney. Ben, please go ahead.
Oh, g'day, Brian and James, can you hear me?
Yes.
Yes.
Hi, Ben.
Yeah, just a couple from me if I can. Just in terms of, you know, your Myriad product, obviously it's really where the growth is and where you're pushing the sales force towards. Can you give us a breakdown between the Matrix and the Morcells product? And if there's, I guess, any innovative ways that surgeons are using Morcells and, you know, where you see possible indication expansion there?
Yeah. So, you know, definitely Morcells is the stronger of the two products, and I think that's a little bit use case related. So it's about 60 Myriad Morcells versus Myriad Matrix. We tend to get Myriad Morcells used earlier, at you know, particularly where the wound bed is much more uneven... and it may not be so suitable for putting a flat sheet graft onto it. So, you know, in terms of indications, I think both products are being used across a pretty wide range of procedures.
And then just a second one. In terms of your R&D spend, I'm not sure what kind of guidance you've put out about that. Do you see that falling in an absolute sense from here, now that it looks like the Enivo spend has potentially peaked?
Yeah, I think it's reasonably static in an absolute sense, you know, over the next few years. So, you know, on a kind of relative basis, you know, decreasing to something like, you know, 10% sales. But, you know, we'll see that coming into play over the next couple of years, but, you know, staying reasonably static from an absolute, but on an absolute basis.
Great. Thanks.
Okay. So thank you for that, Ben. We have come up against time today, so thank you all for your great questions. Brian, I'll hand it back to you for any closing remarks.
Great. Thank you, Anita. Look, you know, it's been a year of a bit of successes and challenges, and we think that we, you know, are now set up for you know, a return to you know, good growth both across both parts of our business over the coming years. So, yeah, excited about the next 12 months. Think that we have, you know, some good fundamentals in place, a lot of good initiatives across the business to you know, continue to grow our sales and you know, capitalize on the great products that we have. So thanks, everybody, for joining, and you know, appreciate the questions and appreciate the comments and feedback. Thank you.