Aroa Biosurgery Limited (ASX:ARX)
Australia flag Australia · Delayed Price · Currency is AUD
0.5600
+0.0200 (3.70%)
Apr 28, 2026, 4:10 PM AEST
← View all transcripts

Earnings Call: Q4 2023

Apr 26, 2023

Operator

This meeting is being recorded.

From release on the ASX this morning. I'll just remind you that you can ask questions through the Q&A function at the bottom of your screen, and we'll get to those at the end of the presentation. Brian, I'll now hand it over to you to get started. Thanks so much.

Brian Ward
Founder and CEO, Aroa Biosurgery

Great, Simon. Thanks for that, and thanks to everybody, for joining the call this morning. We're gonna run through our some preliminary full year results. Look forward to talking about those. Just normal disclaimer. Just quickly on the cash flow. Our cash receipts from customers were $12.3 million during the quarter. We had net cash outflows from operations of $1.9 million for the quarter. Net cash outflows from investing activities was $1.8 million for the quarter, and that really reflects our investment into plant and equipment for additional manufacturing capacity. We ended the quarter with strong cash balance of $44.7 million as of the end of the 31st of March.

In terms of high-level numbers. Our full year product revenue number was NZD 60.4 million. Really thrilled with that. We came in, you know, between our guidance of NZD 60 million and NZD 62 million. That, you know, that's up significantly on last year, so 55% growth on last year. Our total revenue was NZD 63.1 million. That's up 60% on last year. You know, we're seeing really strong, solid growth coming from our Myriad portfolio and also, you know, continued growth coming through from TELA Bio, which really is setting us up extremely well.

From a gross margin perspective, we made some really good strides during the year in terms of improving gross margin in the first half of the year. We've maintained that in the second half of the year, coming in at 84%, which was spot on guidance. Again, thrilled with that and that's a number that we believe is certainly sustainable. From an EBITDA perspective, normalized EBITDA perspective, we're positive. The details of that will come through in our full year financial results. We're obviously working through the collation and auditing of those numbers at the moment. For the full year, sorry.

At the end of the year, cash balance of NZD 45 million, versus our guidance of 50, and there's, you know, some timing impact in that cash balance. Sort of in summary, if you look at that, you know, strong revenue performance, you know, strong growth, really strong margins, and the company's, you know, extremely well-positioned from a cash perspective. You know, really thrilled with how that's gone. In terms of highlights, you know, we continue to make good progress with our U.S.-based field sales team. That number's been consistent over the last quarter. We're at 40 reps at the moment, an increase in the number of active accounts for Myriad, so we're continuing to grow these accounts.

That's now up to 166 accounts. We have four reps that have a run rate now in excess of $1 million, and 10 reps with an average run rate over half a million dollars. You know, we're continuing to see the reps sales productivity improve, which is, you know, extremely heartening. From Myriad perspective, Myriad continues to be the major growth driver. That's the combination of Myriad Matrix and Myriad Morcells. As I've been saying through the course of the last year, Myriad Morcells has gone extremely well for us. From a sales mix perspective, probably represents almost 60% of our Myriad sales now.

We're finding that the use of Myriad Morsels is quite different from many of the other powders on the market. It's commonly being used as almost like an intermediate form of Myriad, so halfway between a powder and a matrix. A really nice, conformable graft. It's a coarser product compared to many of the powders that are on the market, and it's being used in a different way. To respond to that, we also have developed a very fine version of our Myriad Morsels product as well. That's currently being prepared to be shipped to the US, and we'll launch that at the beginning of May. You know, we expect that, you know, Myriad Matrix will be used alone.

Myriad Matrix will be used in combination with this new fine powder as well. Then Myriad Morsels will continue to be used as a conformal graft on its own. Overall, you know, with that Myriad portfolio, we see a really strong opportunity here for continued growth for that portfolio over the next, you know, two or three years. From a clinical development perspective, the Myriad Master clinical registry is tracking very well, so we now have 156 patients recruited into the registry. That's over half of the patients already recruited, which is great. You know, with the mix within that registry is beginning to evolve a little bit. When we started doing the registry, we had a high number of cases in pediatric surgery.

As we've got further into the registry, we're now bringing in a whole range of other sorts of cases, so colorectal cases, trauma cases, and, you know, a mix of some of the inflammatory skin diseases as well. Really pleased with how that's tracking, and it's certainly gonna be a very important source of clinical evidence for our products. Symphony, that's our skin substitute product for sale in the outpatient wound center. We're preparing to launch that product this week here in the United States. There's the major wound conference happening in Washington, D.C. That's SAWC Spring, and we have a formal launch of Symphony at that conference. That's a, you know, new growth opportunity for us this year.

You know, probably be getting ourselves going this year and then really expecting to get, you know, really gain some significant traction with that in the following year. As we've mentioned previously, in our quarterly, you know, we're thrilled that we've had been awarded a contract with Premier for both Myriad and Symphony. Endoform will be added to that contract in April as well. We now have all of the major GPOs in the U.S. that we have contracts for for our portfolio of products. We cover, you know, over 90% of the hospitals in the U.S. have access to our products through their primary GPOs. We're very well-positioned from a GPO access perspective.

We recently received a 510(k) clearance for our Enivo pump and catheter. These are two key components of our Enivo tissue acquisition platform. We're gonna talk a little bit about that later in the presentation. You know, extremely pleased to have those two components cleared. They certainly de-risks the clearance of the whole platform. You know, there's a huge amount of work that's gone into getting these products to this stage. We're in the process of working with the FDA to finalize the requirements for the clearance of the third component, which is the ECM sleeve. We expect to be able to come back and, you know, announce the pathway for that over the next 3 or 4 months.

We'll provide an update on that at that stage. TELA Bio, things have gone very well there. They had a good year last year. They have recently re-released guidance for the full year, which was $60 million-$65 million versus $41.4 million last year, strong growth there. And in addition to that, you know, they're now in the process of completing a round of almost about $45 million, which means that they'll have, you know, be well-financed to continue to build their commercial organization in the U.S. You know, TELA's well capitalized. They're continuing to hire sales reps.

They've certainly got good clinical data coming through, good GPO access, so I think they're really set up to, you know, do very well over the next over the next two years. Just wanna talk a little bit about our existing products and how Enivo fits into our portfolio. All of our current products that are commercial at the moment are based on our AROA ECM platform. What we see with this platform is rapid formation of this robust granulation tissue, which is a critical step in healing, and that really provides the basis for a wound to heal.

When we benchmark our products in the market, there's some clear differences with our base technology, and we see that across all of our technologies, whether it be in OviTex, whether it be in Myriad, whether it be in Symphony. For Aroa, the opportunity that we're targeting is in soft tissue reconstruction. We've designed a range of different devices for use in soft tissue reconstruction, the Symphony device, the Myriad device. We're also using Endoform in chronic wounds. We're predominantly targeting plastic surgeons, general surgeons and trauma surgeons. What we see in a lot of these procedures, there is that when surgeons separate tissue, they create a cavity.

That cavity delays healing, but it also can lead to downstream complications where fluid accumulates at that site, and that can lead to either serum or blood forming there, slowing down healing. Also potentially leading to the wound becoming infected or the wound breaking down. That was really the genesis of the idea to develop the Enivo product. Our thought was that, you know, if we could combine our AROA ECM products with a product that removed that cavity that sits around the area where our products are implanted or used, that would firstly reduce the risk of those complications developing, secondly, help with that tissue healing process and allow that to happen faster and allow there to be fewer complications at the site.

The quality of the healing was better at that site. You know, when we've talked about, when we've talked about Enivo in the past, we've talked about Enivo in terms of managing dead space and being used in combination, you know, with our, with our AROA ECM based products. I think there's an important point to make here, and that is that, while both, Myriad, Symphony, Endoform, and our Enivo products, you know, represent opportunities in their own right, and we, you know, we've talked about a market size for our soft tissue reconstruction products as $1.4 billion, a market size for Enivo as $1 billion. The real opportunity for these products is where they're used together.

We see this as being a way to really change the standard of care in treating these soft tissue reconstructions to accelerate the rate of healing because you don't have this cavity that forms, that delays healing because you do have good apposition of tissue, and to give you a better outcome. One of the things about this combination is we think it really provides an opportunity to significantly differentiate the Aroa product portfolio offering and allow us to really create a step change in soft tissue reconstruction. You know, we see this as something that's very proprietary to Aroa and can make a significant difference in these surgeries.

There's a, you know, there's an opportunity for us for our products alone, but there's also a really important opportunity for us in terms of combining these products and having that combination be able to really change the, the quality and the rate of healing. I think that's an important thing to note with these combinations. Just briefly in terms of a little bit more detail around the clearance with the FDA. The, the Enivo system is comprised of a pump, a catheter, a silicone catheter that's then inserted into a implant which is made up of an ECM sleeve. The FDA has cleared the pump, the vacuum device, and the catheter, but it hasn't cleared the sleeve.

The reason for that is that there is a comparable product on the market that includes a pump and a catheter, but there's nothing comparable that also includes a ECM sleeve. We need to provide some additional data to the FDA to satisfy them around the safety of having the addition of the ECM sleeve. I mean, we provided some justifications to them on it. Obviously ECM is used in our existing products and many existing procedures. They just wanna see the use of that ECM sleeve in combination with the silicone catheter. We're working on putting some more data together for that.

Once we've put that submission in front of them, you know, we'll go through a round of questions just to clarify exactly what their requirements are, and that may or may not require additional preclinical or clinical work. At this stage, it's hard to be really clear on what that timeframe is. It could be a relatively short timeframe that may be that we are able to clear this device within the next 12 months. It could be that it requires more extensive clinical data, and that may take us up to 36 months. I think within the next 2-3 months, we'll have a very clear view of the timeframe for this full device to be cleared, and, you know, what the, what the likely costs of that are.

Just, sort of touching on catalysts and milestones, for us. You know, I think we've got, continue to have really good sales and momentum on the Aroa side. I think if you look back over the last three years, we've had strong growth year-on-year. It's important to note that we're still only addressing a tiny proportion of the total accessible market for our products. We are just scratching the surface, you know, and just getting going. We're certainly just building a sales team, just building clinical data. You know, there's a huge amount of upside here for these products in the near term. TELA Bio, very similar state. Some great data there in terms of recurrence rates.

A lot of effort going into building out the commercial operation, the sales team. You know, I think with the recent funding that we talked about, you know, we're gonna see that, you know, increase as well. I think, you know, really, starting to see good momentum, you know, on the TELA Bio side as well. The Symphony product launch is important, so that's a, you know, very large opportunity for us. Fits well with our existing business. You know, we're targeting a hospital outpatient wound centers in hospitals where we're already selling Myriad. We already have access into those hospitals. We have established relationships in those hospitals, so it's a nice add-on to our existing Myriad business. You know, Enivo, we've made good progress with Enivo.

We've significantly de-risked the clearance of that of that product. You know, as I said earlier, we'll have a much, much clearer view of timeframe on that in the next couple of months. You know, from a COVID perspective, you know, we are seeing, you know, an almost normal state in terms of, you know, operating capacity in hospitals. Still a little bit of slowness on the administrative side, but certainly, you know, no significant lags there that are gonna affect our performance and, you know, our ability to continue to grow the company really aggressively over the next couple of years.Just in terms of investor events coming up. We have our full year results and guidance webinar on the 30th of May, that'll be a virtual event.

We are planning to put on a special investor meeting on the 1 June in Sydney, between 1:00 P.M. and 4:00 P.M. We're planning to bring a slightly extended team to Sydney for this and provide a deep dive into some of the critical areas of the business and how we think about that over the coming year. I think it's a great event to attend. That'll provide some more insight into, you know, how we're thinking about the growth opportunity in front of us and you know, how we're seeing things play out across the business. I'm gonna leave it there, Simon, and pass it back to you for questions. Thank you.

Operator

Great. Thanks, Brian. First question is from Elyse Shapiro at Canaccord Genuity. Can you just talk to the timing to see the impact of the Premier, Inc. addition for Aroa products? Looks like this is slower than expected for TELA, is this something that's being experienced across the board?

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah. I know for TELA it has been a little bit slower than expected. I think, you know, that will pick up. I mean, our own experience has been, you know, pretty positive with Premier, to be honest. I mean, Premier is, for us, you know, now our number one GPO. You know, it's one of the largest GPOs. For us, you know, I think it's like 40% of sales now going through Premier. Premier's been, you know, has been a strong GPO for us.

Operator

Great, thanks. Myriad looks to have strong momentum. What are hiring intentions? It looks like Myriad's on track to more than double revenue in FY 2024. Is that a fair assumption?

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah. Look, I think exactly. I mean, we're growing by, I think it's 233% this year for Myriad, that's gone really well. You know, we'd expect to, you know, double that revenue over the next 12 months as well. It's, you know, continues to go well. You know, from a, you know, sales force perspective, you know, it's two things we're focused on. Focused on, you know, our sales people maturing in their territories, you know, over the next couple of years and improving their net run rate, you know, as that access improves as well. Probably secondarily, adding more people.

You know, I think the most important thing for us is to really ensure that, you know, we get our sales people to high levels of productivity over the next 12 months. You know, we will add people. You know, we may add 5 to 10 people over the next, you know, over the next 12 months. I think we're just gonna see how that goes and just how, you know, what the environment looks like over the next 12 months. We'll provide more detail about that, you know, in May.

Operator

Great. Thanks, Brian. Good morning, Brian and James. I know in the past you were reluctant to provide any color about long-term financials. Given the reasonable large TAMs potentially available to Aroa, could you please give shareholders an aspirational feel on where you see Aroa in five years' time? How large do you see Aroa getting in terms of revenue and profitability?

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah, look, I think, I mean, I would sort of... You know, there's a couple of ways to look at it, right? I think we're in large markets. We're scratching the surface of those. We're growing, you know, year-over-year. You know, we're growing at sort of high rates, you know, $10 million-$20 million a year. If you look forward, I think, you know, you could see Aroa being a company in excess of $100 million within 2-3 years. I think that's a pretty reasonable number. There's no reason to think that there's a ceiling on that level of growth.

You know, we should be able to continue to build momentum over time at, you know, at a high level of growth, certainly in excess of 30%, you know, potentially, you know, potentially higher. I think, you know, there's a, there's a genuine opportunity to build a, you know, globally leading soft tissue reconstruction company with this technology, you know, over 5 to 10 years that has, you know, revenue north of NZD 200 million. I mean, that's the plan. I mean, our plan is to build a very large successful company here.

Operator

Great. Thanks, Brian. Aroa was EBITDA positive in FY 23, including Enivo. How much was spent on Enivo in FY 23?

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah. James, do you wanna address that?

James Agnew
CFO, Aroa Biosurgery

Yeah. Look, a large portion of our R&D was spent on Enivo. It's in excess of NZD 6 million. I mean, look, we'll provide more, you know, more color on that when we release our results in the next three weeks.

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah. I think there's one thing to add to James's comment there. I think if you, if you think about, you know, the expense on Enivo, if we weren't investing that NZD 6 million or so in Enivo, we backed that out, you know, then, you know, Aroa would already be a highly profitable company, you know, at where we are in our kind of growth cycle at the moment. You know, the fundamentals of the company are extremely good. You know, we're choosing to, invest in Enivo because we see a fantastic opportunity, for that product and because we see it as an opportunity to really position us very uniquely within the market. We're strong believers in Enivo. We think the combination of our products in Enivo will set us up really well for the future. It's worth the investment.

If we had postponed that investment or we didn't make that investment, I think people would be looking at Aroa and thinking that's already a highly profitable company at a relatively low level of sales.

Operator

Great. Thanks, Brian. just on Enivo, when do you expect to see tangible sales, given you've recently had the approval?

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah, at the moment, we, you know, it's certainly at least 12-18 months away, you know. That's even if we were to, if we were to get the product declared reasonably soon, there's, you know, we would be undertaking some early experience clinical development with it. You know, it's a very unique product that needs to be put in the hands of, some really well-regarded surgeons, you know, in that initial period of use. So yeah, it's a little way away. You know, we think that Enivo can be a huge catalyst for the company. Once we get some confidence in the performance of Enivo, then, you know, we think that that can, you know, really drive some strong growth for us.

Operator

Great. Thanks, Brian. Just a question from Sebastian Clemens at Jarden. The cash balance of New Zealand NZD 44 versus Ireland NZD 50 was due to timing of product revenues. Is this something we should therefore expect to correct next quarter?

Brian Ward
Founder and CEO, Aroa Biosurgery

Yeah, no, absolutely. We should see a correction next quarter.

Operator

Okay. I think that concludes the Q&A segment. Just a reminder on the Investor Day, the first of June, if you did have interest, just email the details at the bottom of the ASX release. Brian, I'll just hand it back to you for closing remarks.

Brian Ward
Founder and CEO, Aroa Biosurgery

Great. Thanks, Simon. Look, you know, we're delighted that we've delivered the result. We have, you know, strong growth, you know, it's 32% on last year, which we think is fantastic. You know, we're establishing a really strong platform here to build a successful business in the US. You know, I think it's the third year in a row where we've met our guidance, so very pleased about that as well. Really, you know, also pleased to see, you know, our partner, TELA Bio, you know, doing well in terms of their growth, putting on some, you know, great guidance for the coming year and also, you know, putting fuel in the tank and, you know, raising some more money to put them in a good state.

I think all of it bodes very well for Aroa over the coming 12 months.

Operator

Perfect. Thanks, Brian. Thanks all for attending.

Brian Ward
Founder and CEO, Aroa Biosurgery

Thank you.

Powered by