Full Year 2024 Polynovo Ltd Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Lyanne Harrison - Bank of America - Analyst : Let me start with the (technical difficulty) on slide 8, which was the platform technology, some interesting products in there. But I just want to get a better sense of those synthetic allograft and antimicrobial products that 15- to 36-month timeframe is actually quite a long range. Can you give us a sense of where you are on product development on those products? When do you expect to file for 510(k) approval? And when do you expect to launch for those two products?

Question: Lyanne Harrison - Bank of America - Analyst : Okay. And just to clarify, you saying, is it currently being tested with multiple surgeons, is that right? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 23, 2024 / 4:00AM, PNV.AX - Full Year 2024 Polynovo Ltd Earnings Call

Question: Lyanne Harrison - Bank of America - Analyst : And what has the feedback been to date on some of that testing? Has there been any feedback on the product itself that might lead to product going back into development?

Question: Lyanne Harrison - Bank of America - Analyst : Okay. And if I could just have another question on outlook for '25. I know, David, you mentioned you're not going to provide guidance. The growth rate, obviously -- very strong growth rate for financial '24, but still not sure what that would be in '25. But how do we think about that growth? So you ended up the year with about $10 million revenues per month. If we kind of assume that sort of cadence for '25, we get to about $120 million or thereabouts, but expect some uplift there. But if we think about like -- let's just focus on the United States, how many more accounts can you add to that? How big are those accounts? And what are you seeing, particularly in the United States, in terms of the depth and penetration you're getting in those accounts?

Question: Lyanne Harrison - Bank of America - Analyst : No problem. And just one comment there on United States growth. There was a recent local coverage determination. I think it was in May of this year where CMS found that there was insufficient evidence that NovoSorb BTM was effective for diabetic foot ulcers, but Medicare still covers it despite that limited evidence. Has that changed the surgeon use or surgeon's approach to using NovoSorb products for DFUs?

Question: Shane Storey - Wilsons - Analyst : Swami, I'm going to sort of return to one of Lyanne's questions just as a follow-up, just around -- not so much about accounts, but like if we think about the volume growth that PolyNovo saw this year in the US, say, an absolute centimeter squared, for instance, would I be thinking -- would I be right if I thought that maybe 1/3 of that growth came from new accounts, maybe 2/3 from existing accounts? I've just put a number out there for you to correct me. I'm only after a rough split. I just think many people on the call would find that useful for modeling '25 and '26.

Question: Shane Storey - Wilsons - Analyst : Yes. No, that is helpful. My second question just goes back to what Swami, you were saying just a minute ago about the idea of limb salvage possibly being a conduit to the DFU market. And on that, am I right in thinking that as the DFU market stands today, there might be a little bit of pushback against the synthetic given the collagen sort of dressings have been so dominant for so long. And then -- I mean, a, is that right? And then b, how do you see results in limb salvage coming out, say, into the literature as your materials being used in that setting, please?

Question: Shane Storey - Wilsons - Analyst : I'll get off and let my colleagues have a swing.

Question: Rachael Harwood - Macquarie Research - Analyst : Just firstly, I guess just on gross margins. I guess how are you thinking about next year just given more diversification of sales outside of the US? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 23, 2024 / 4:00AM, PNV.AX - Full Year 2024 Polynovo Ltd Earnings Call

Question: Rachael Harwood - Macquarie Research - Analyst : That's great. And you mentioned India, just a quick one there. I mean you won your first tender in India. Could you maybe just talk quickly how these tenders work and maybe your expectations for India into next year?

Question: Scott Power - Morgans - Analyst : Congratulations on that result. Just a quick question, just on that PMA. Assuming the trials you say has now been completed, what's your expectation on the timing of the approval?

Question: Andrew Paine - CLSA - Analyst : Just looking at the CapEx for the new facility to support 5 times increasing current capacity, just wondering where you are now in terms of utilization of your capacity and when that comes online and just making sure that you're going to be able to continue to ramp up as you are and not hit any capacity constraints?

Question: Andrew Paine - CLSA - Analyst : That's great. And just some early thoughts on MTX and/or your SUPRATHEL product. I think I said that right. How is that looking? Does that increase operating leverage meaningfully once the ramp-up comes through, assuming the clinicians and the sales staff kind of look after multiple types of wounds?

Question: Shane Storey - Wilsons - Analyst : Sorry for the follow-up. But I just heard you, Swami, talk about the thicker version of MTX. That is something that we have heard of anecdote in our surgeon calls or the idea of that. Maybe if you could maybe talk about like the particular sort of clinical settings where you think that offers a difference? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 23, 2024 / 4:00AM, PNV.AX - Full Year 2024 Polynovo Ltd Earnings Call