Aroa Biosurgery Limited (ARX.XA) Earnings Call Transcript & Summary

Okay. Let's begin. Welcome to Aroa Biosurgery's Investor Webinar and Q&A, following the company's February 2026 Business Update Announcement released this morning to the ASX. [Operator Instructions]. There will be a presentation lasting approximately 10 minutes, followed by a Q&A session. The webinar will conclude at approximately 9:30 a.m Australian time. [Operator Instructions]. On behalf of our Aroa today, we have Brian Ward, Founder and CEO. I'll hand over now to Brian. Please go ahead.

Great. Thank you, and welcome to everybody to this business update. So as you're probably aware, we're no longer required to do the quarterly cash flow reporting. So we thought that we'd take the opportunity as we go forward now on occasions to provide a business update on sort of key matters, happening within the business. So that's the purpose of today. So I want to just quickly jump into the agenda. So we're going to talk about the Myriad trauma study, which was released recently, some changes that have been happening in terms of Symphony reimbursement, our commercial strategy for Symphony and then just general momentum across the business. And I want to talk briefly about guidance as well. So we released the results of a trauma study from our MASTRR register recently. So this is for those of you that remember, this is a large ongoing prospective multicenter observational study of bioscaffolds that Aroa is undertaking. Looking at the use of Myriad and a wide range of different surgical procedures. So -- this registry has been running now for 3 years or so. And we have the ability to recruit into this up to 800 patients. So we are now 450 patients into this registry. And we're really beginning to accumulate a significant amount of data in terms of how Myriad performs at a wide range of soft tissue reconstruction procedures. So -- we recently published a subgroup analysis of trauma patients. So this was done 49 patients with 61 defects in four U.S. Level 1 trauma centers. So these are, those trauma centers where the most severe trauma cases are treated in the U.S. And so we've got a nice group of these centers participating in the registry. What we saw with these 49 patients was that we achieved fully vascularized tissue coverage in a median of 25.5 days, typically with one application, and there were no device-related complication. So a very strong result. And when we compare that to what's been published in the literature with comparable products. And what we see is that Myriad's clinical outcomes are at least equivalent or better with fewer complications and fewer product applications versus those other scaffolds. So one thing I will note here is that because it's a single-arm prospective study, it's -- and the variety of cases is quite mixed. It's very hard to do a direct comparison with other products. But what we've done is we've reviewed all of the published clinical literature for the key products that are being used in this area. And we're able to show that typically, as we say, clinical outcomes are very good. But critically, the complication rates are really low. And typically, we can achieve with Myriad, with a single application, what often requires multiple applications with other products. So we're really delighted with this result. I think it speaks very well to both patient outcomes, but critically for hospitals, it means that often, they're only needing to take the patient once to surgery, not needing follow-ups that has huge implications in terms of the cost -- the total cost of care, the time and surgery, the ongoing treatment of that patient. So with that this is consistent with what we've seen in other trauma publications, but also more broadly, what we tend to see with Myraid across a wide range of procedures where it's being used is that rapid tissue formation, single applications and also not having complications associated with the device treatment. So thrilled about this and it's kind of accumulating this body of evidence, which is very important in terms of gaining clinical conviction and conversion of customers. So I want to talk briefly now about Symphony reimbursement. So this is an area where there's been a range of changes coming pretty quickly. And what we're seeing is [ Symphony ] is looking to reset the reimbursement environment in the U.S. now. Those proposals have been met with a lot of pushback by a variety of companies, but also in some situations by providers in different settings as well. So at the moment, what they are proposing is a flat fee of $127 per square centimeter, and that came into place from the 1st of January. So this is a major reset in terms of pricing. We've seen pricing $400, $500, but at the extreme end, $2,000 or $3,000 per square centimeter for a product that really showed no difference in the efficacy of the product. So while that pricing has stuck, the [ CMS ] and the Medicare Administrative Contractors or the MACs had proposed to change the rules, if you like, for how this can substitute products were reimbursed. So these rules were documented in what they call local coverage determinations and they were proposing to limit the number of applications and also only allow products that had randomized controlled trials showing the efficacy and diabetic foot ulcers and venous ulcers to be used would be paid for. Now -- there was a lot of pushback from industry against that. And so what we've seen is those LCDs have been withdrawn I mean what that means is that for the next year, you don't need to have that clinical evidence in order to support the use of your product. Now we see these changes as being coming into place over some time. So while they have been withdrawn now, we certainly know this is the direction of travel from [ CMS ]. And we think that they will be put into place at some stage. So this is leading to a lot of market disruption in this segment. So with the resetting of pricing and the likely introduction of the RCTs we see that many of the current players in this market are not going to be viable or able to participate within this market. And this is obviously kind of change the dynamics in the market. It positions Symphony very well for this new environment. And so we're really excited about what this may mean for Symphony going forward. What we do expect over the rest of this year is that there may be some changes. So we're aware of maybe the requirements come into place for RCTs, potentially the number of applications that are allowed changing and maybe even the payment level is changing. So we don't believe that the reimbursement arrangements are fully settled and that they were sort of prepared for changes in those over the rest of the course of the year. I think one thing that we do feel very confident about is that we think that with the pricing that we have, the fact that we are concluding the RCT with Symphony and that we can flex our strategy based on changes that happen in the environment. We think that Symphony is very well positioned for the changes in this environment as they come into place. So all in all, certainly for the next year, we're in a very competitive position. We feel that we can begin to get on and sell Symphony and the changes that do come into place should be -- should favor Symphony. So from a commercial strategy perspective, our current full-time reps in inpatient procedures and hospitals. So they're already in the hospital environment. What we're going to be doing is I'm focusing on hospital outpatient departments. So many hospitals also have associated outpatient departments that are down the corridor or up or down a floor -- and within a hospital, so we're asking our inpatient sales reps to also call on these hospital outpatient departments. So it fits very well with our existing sales footprint. In addition to this, there may also be opportunities for us to do a variety of distribution partnerships in areas that we are not covering or don't intend to cover in the future. And there's a number of different sites of care whether this may be the case. So this is something that we're exploring. We're excited about this. We think there's some great opportunities here. I think the important thing with Symphony is that particularly for our own sales team, it's something that's added to their existing offering. Something they should be able to sell in addition to what they're doing and should increase the sales productivity and efficiency. So we think it is through a really nice add to their portfolio, and we'll put them in a very good position going forward. So just sort of when you pull all those things together, what we're seeing is great success with Myriad, both clinically but also from a sales perspective, being successful broadly across a wide range of soft tissue and procedures, particularly seeing good traction in trauma, good traction in low limb and salvage procedures, which are the key procedures in hospitals. The evidence for our platform technology is building strongly. So strong evidence coming through for Myriad. We think that the results that will come through from Symphony also going to support the use of Aroa CMS as well. Symphony is a significant new opportunity for this, and we think that could really move the dial for sales over the coming years. So we're very excited about that. And with TELABio, TELA is an important component of our business. Obviously, it's a very lucrative part of our business for us and a significant contributor to our overall profitability. So there's a group of things here that come together really nicely to build momentum going into next year. Just want to talk about guidance. So at the beginning of the year, we put guidance out for revenue $92 million to $100 million on a constant currency basis and normalized EBITDA of $5 million to $8 million -- looking at where we are at the year now, so we're 2 months to run. We've got a pretty good view of how things look in terms of we're going to end up at the full year. And we're seeing the actual sales track towards the upper end of both revenue and EBITDA. So thrilled about how that's tracking, certainly coming off the back of strong sales for Myriad. Really helping to drive that. So a good finish to the year and very excited about how that sets us up for the coming financial year. So I'm going to pause there and open things up for questions.

Thank you, Brian. So we'll now move on to the Q&A session, so you're able to type your questions, and I can see that we do have a couple through now. So we have a question from Susan Robinson, and she's asked, how does the new flat rate compare with our costs and our present charging in the market.

Yes. So the flat rate is good for us. I mean, we -- it's certainly -- when you sort of think about the economics, the reimbursement is $127 for doctors. And then within both seating, both the physician office and the hospital outpatient department, the price is going to be the same. So that's a change. Our selling price is going to be -- so it's definitely less than that, but I'm still in a position where we're able to achieve very high margin. So I think it's for some product ranges where their cost of goods is very high and also where there's a number of different layers in distribution, in selling, I think it puts a lot of pressure on those companies in terms of pricing. But with our cost structure, with our commercial strategy, we're in a very good position.

Great. So we just have a question here around TELABio if they were to enter administration, what would that mean for us in our sales force.

Yes. Look, TELABio as you're probably aware, raised some funding at the end of last year, and that should give them a couple of years runway. They're still continuing to grow at a reasonable clip, and they are expecting to transition towards profitability. So -- we've got confidence in TELABio in terms of being commercially successful. If you think about if they were to go out of business, then our sense is that it's a very valuable portfolio of products that they've built there. So $80 million or so of revenue, strong growth, very good clinical results. So net asset, if you like, is valuable in the hands of a number of players. So we don't -- at the moment, we feel pretty good about that, and we see this as a product that still has a very long way to run and will be successful.

Okay. And I've got a question here from Paul Colombo. Just in terms of when you mentioned moving the dial around Symphony sales, could you just give an outline in some context of what we can expect here?

Yes. I think if you look forward over the coming year, and I don't want to talk numbers, but just sort of directionally, I think we would expect Symphony to at least have the same sort of growth trajectory as we've seen with Myriad previously. Now we haven't really been in a position in the past where Symphony was in a favorable reinvestment environment. We've also been a situation where there was a number of players that were in that market and the incentives were skewed. So that whole environment has been reset. So -- we could expect Symphony to perform much better than that. I think it's early days. And it will depend a little bit on where the CMS holds the course with reimbursement. And the rate at which companies either exit from this area or a number of players that are left in the market. But I think it's at least as good as we've seen with Myriad, but I'd like to think it's a lot better than that.

Great. So Michael would like to know whether the withdrawal of the LCDs at the state is affecting any go-to-market plans for Symphony.

No, it's not. On the contrary, really, I think it's given us a lot more confidence. So -- what it means for most companies is that while the pricing requirement has changed and so there's a capital on pricing, the requirement for an RCT is not there. So it may have held up, the LCDs were still in place that may have held up our ability to get Symphony reimbursed, because we hadn't published the clinical results from the RCT. I think now that being withdrawn, that's not an impediment. So it puts us in a good position. But as I said earlier, we do believe that the requirement for RCTs is likely to be reintroduced further down the line.

Scott [ Aker ] would like to hear from you just around profitability.

Sorry, I missed that Sarah, was the last word. .

Just your comments on profitability and our path profitability .

Yes. So look, we've been -- we are profitable, and we have been transitioning towards profitability and guidance has us being profitable this year. So $5 million to $8 million in EBITDA. We've been cash flow positive for the last 4 quarters. Will be cash flow positive for the full year. So I think we're a long way through that transition now to be unprofitable on an ongoing basis. So we're not in a situation where we need to go back and continue to raise money. I think we've got various good prospects. And the level of profitability should increase over the coming years.

Right. So Paul Colombo has asked when will the results of the Symphony RCT been published. .

Yes. So we've -- the study is wrapped up, and we've been going through the sort of phase of getting all the data together, working with the [indiscernible] to lock the database and get that prepared for statistical analysis. So that's -- that will happen over the next month or so. So I think with everything going in the right direction, we should have that by the end of the fiscal year.

Right. Okay. So that concludes the questions. So I'll just hand over to you, Brian now to close out the webinar.

Thanks, Sarah. Look I think the high-level takeaway from this is, we sort of feel like we're in a great position. So Myriad performing really well, Symphony now opening up a large opportunity for us an upgrade to guidance or guidance being towards the top end as well. So we think coming out of financial year '26 with a lot of good things happening and setting us up for a strong FY '27. So thanks for attending and look forward to delivering the full year results in May.

Excellent. Thank you, everyone, for attending.