PolyNovo Limited (PNV) Earnings Call Transcript & Summary

Welcome to shareholders. It is my pleasure to welcome you to the PolyNovo Annual General Meeting for financial year 2026. My name is Leon Hoare, and I'm the Non-Executive Chair of the company. We have a quorum present, so I declare the 2026 Annual General Meeting of PolyNovo open. I'm delighted to be able to extend a warm welcome to our shareholders joining us here today and to those who are participating through the online meeting platform. I would like to start by introducing my fellow directors from the end, Mr. Andrew Lumsden; Mr. Rob Douglas, Dr. Giesen. Our newly appointed Nonexecutive Directors, Mr. Andrew Price and Mr. Dean Phizacklea. Dr. Robyn Elliott and Ms. Christine Emmanuel-Donnelly, who are unfortunately unable to join us today. Dr. Robyn Elliott and Ms. Christine Emmanuel-Donnelly are not standing for reelection and as a result, will retire from the Board at the conclusion of today's meeting. On behalf of the Board, I thank them for their very significant contribution to the company and wish them well for the future. I'd also like to introduce our Company's Secretary, Amy Demediuk and our -- and welcome Mr. Bruce Peatey, our CEO. You will hear lots from Bruce shortly. We also have in attendance, Ashley Butler, Mark Bennett, Rekkaa Mooorthy from our audit firm, Ernst & Young. Welcome. Also in attendance are members of our executive leadership team sitting in the front row. Before I formally address the meeting to reflect on a year of significant progress for PolvNovo, I would like to share one part of a 3-part patient story that we will share at key intervals throughout the meeting. Shareholders for me with the 2026 Annual Report will recognize the patient [ Sam Nai ] from the Torrastraigt, who was bitten by a shark 1 year ago. We were fortunate to film with him in July and are pleased to share his story with you today. Recovery from such a significant injury is not linear and is enabled by novel technologies, the care of clinical teams and support at home. [Presentation]

FY '26 was a year of very significant progress for PolyNovo. We strengthened the foundations required to support our continued evolution of global medical technology company. This slide highlights a decade long journey demonstrating that PolyNovo delivers on growth. In FY '26, we again delivered strong revenue growth consistent profitability and positive cash flow, creating powerful momentum and positioning PolyNovo to pursue its strategic growth opportunities with confidence. Several key clinical, regulatory and capital programs were advanced in the period. The clinical study report for our U.S. pivotal randomized controlled trial was finalized and work progressed on the premarket approval submission for NovoSorb BTM, supporting the full thickness burn indication in the United States, and Bruce will tell you more about this shortly. We also continued expanding our manufacturing capability in Port Melbourne, supporting future capacity requirements. We have refitted the already new R&D innovation center post the fire of November 2025 and the R&D team now have largely reoccupied the facility. These initiatives represent important milestones and reflect the increasing maturity, capability and scale of the organization. We will reflect -- sorry, we will continue to invest for growth. FY '26 was also a year of renewal for the Board. We have continued to evolve the Board's composition and skills mix bringing additional capabilities, experience and perspectives to support PolyNovo's next stage of growth. Following Christine Emmanuel-Donnelly and Robyn Elliott's decision to retire at this meeting, we recently announced the appointments of Dean Phizacklea, Andrew Price as Non-Executive Directors, Charmaine Gittleson also joined the Board as a Non-Executive Director in April. Charmaine, Dean and Andrew bring a wide array of complementary skills, expertise and perspectives that will further strengthen the existing Board. I know shareholders will join me in extending my sincere appreciation to Christine and Robyn for the important role each have played in PolyNovo's development and success. Their stewardship over many years has supported a period of very significant growth and transformation of the company. The Board has also reviewed its governance frameworks, it's committee structure, including establishing a dedicated nomination committee and refreshed its charters in its key policies. These updates strengthen oversight, accountability and strategic alignment as PolyNovo becomes a larger and more complex global company. Key appointments were also made to the company's executive leadership Bruce Peatey joined as Chief Executive Officer; alongside Dr. Martha Dombrain as Chief Scientific Officer. Amy Demediuk as General Counsel and Company Secretary; and Tyson Parker as Chief Manufacturing and Supply Chain Officer. This has strengthened PolyNovo's capability across global health care, R&D, science, governance, manufacturing, audit readiness and commercial execution. We are focused on enhancing the caliber of our senior leadership as we build the organization's growth and execution focus. Importantly, as part of our investment in the leadership team, PolyNovo has finalized a comprehensive long-term incentive program to enhance our ability to attract and retain high-caliber executives who can deliver sustained high performance aligned to our shareholders' interest. This new scheme is in place from FY '27 onwards. Collectively, this progress positions PolyNovo for the future. We have renewed leadership, strengthened governance, expanded organizational capability and advanced several of the clinical, regulatory and capital programs that will support scale and underpin our next phase of growth. The Board is confident in PolyNovo's foundations and opportunities presented by the NovoSorb platform alongside the team's ability to execute with discipline and purpose. On behalf of the Board, I thank our employees, clinicians and research partners for their contribution throughout the year. I also thank our shareholders for their continued support and confidence in PolyNovo. Thank you. I will now invite our Chief Executive Officer, Bruce Peatey, to address the meeting. Thanks, Bruce.

Thanks, Leon. Good morning, shareholders. Thank you for your attendance today. PolyNovo's purpose is to redefine what is possible with healing. Our focus is on regenerating tissue loss through burns, trauma or surgery. Every day, clinicians use our technology to help patients recover from devastating injuries, avoid amputation and to regain function. more than 130,000 patients have now been treated with Novasol products and that patient impact remains our greatest motivation. The more time I spend with our customers, the people, clinical partners, the more convinced I am of PolyNovo's potential to make a difference in the treatment of complex tissue defects. The strength of our technology is proven. What has evolved is the business around it. Our ambition for PolyNovo is to remain a high-growth company, while becoming a stronger, more resilient and more scalable business. PolyNovo combines a trusted platform with deep clinical relationships, manufacturing know-how and global reach. These advantages have been built over time and are difficult to replicate. That is the opportunity before us and it is what I want to focus on today. FY '26 was an important year in PolyNovo's evolution, which saw the company further translate its strategic priorities into tangible progress. We secured regulatory clearances that support expansion introduced NovoSorb MTX into more hospitals, strengthened leadership team and completed our largest manufacturing facility. Together, these actions expanded our commercial reach and strengthened the foundations for the future demand and the next phase of growth. Operating progress was matched by greater financial discipline. Underlying EBITDA increased by 50.4% year-on-year, and the business generated $9.4 million in free cash flow. Our strength in balance sheet gives us the capacity to invest in growth. FY '26 demonstrated that PolyNovo can expand its clinical and commercial platform while improving the financial strength of the business. Our strategy for the next phase has 3 connected priorities: scale our core tissue regeneration business, unlock the NovoSorb platform potential and build the capabilities required to support a significantly larger global company. The first is the principal driver of near-term performance. The second creates a longer-term value for the NovoSorb platform and the third enables them both, while maintaining quality and financial discipline and improving operating leverage. Our largest near-term opportunity is to deepen adoption where we already have credibility, reaching more clinicians and treating a broader range of patients within existing accounts. That starts with burns, where NovoSorb BTM is well established and where further growth will be supported by stronger clinical evidence and broader regulatory positioning. The pivotal BARDA-funded randomized controlled trial is central to that effort. Upon approval, the PMA provides an indication for full-thickness burns in the U.S. and has the potential not only to strengthen our position in the United States, it will also support broader adoption in burns and provide a foundation for future opportunities in other major markets. We expect to submit the PMA to the FDA ahead of the previously indicated end of year calendar timing. All manufacturing, validation and clinical activities are required for the submission are complete. And our focus now is on finalizing our high-quality, comprehensive submission package. Complex wound applications are becoming an increasingly important growth engine for PolyNovo. This is not a shift away from burns, rather, it reflects the expanding relevance of our NovoSorb technology. In the United States, these applications have delivered a 3-year compound annual growth rate of 52.8%. And we estimate the addressable patient population across trauma, surgical reconstruction and limb salvage is 3x to 4x larger than burns alone. In the first randomized controlled trial of NovoSorb BTM against standard of care and complex diabetic foot wins at high risk of amputation, treated with NovoSorb BTM healed 2.7x faster. This binding offers encouraging evidence that our technology may be relevant to this clinically important patient group and supports further study. NovoSorb SynPath provides another route to broaden access into complex treatments in the U.S. With launch priority shaped by reimbursement, site economics and clinical workflow, we are currently building that local evidence required to support commercial launch this calendar year. We see SynPath as an additional growth opportunity with its revenue contribution building over the near to medium term. In summary, the core business opportunity is diversified across deeper burns adoption, growth in complex wounds and entry into new settings of care. This is expected to improve the quality of growth over time. The second priority is unlocking the broader potential of NovoSorb as a platform technology. We see significant potential in the platform. Our focus is on converting that potential into value more quickly. We will be selective in where we invest. We will back programs where there is significant unmet clinical needs, a compelling commercial opportunity and a clear advantage for PolyNovo. Where another party is better placed to take an application forward, we will actively consider partnering rather than building capability ourselves. With our Chief Scientific Officer now onboard, we have commenced a comprehensive review of the R&D pipeline to identify the opportunities with the greatest potential to create value. That review will test existing programs such as hernia and breast reconstruction and new programs through a more rigorous product development process, supported by external scientific and clinical subject matter experts where appropriate. The objective is a sharper, more focused pipeline and faster decisions about what moves forward. We will give investors greater visibility as those projects evolve. The third priority is to ensure that we have the manufacturing, commercial and organizational capabilities to support a substantially larger global business. Our largest manufacturing facility has been completed. Its modular design provides the ability to increase output as demand grows. While manufacturing performance, during the first half of FY '26, was impacted by the PMA submission, this is now complete, and production will solely focus on commercial output moving forward. We expect to begin transitioning manufacturing to the new facility in the second half of FY '27. And we're building the commercial and organizational capabilities required to scale, adding qualified talent to commercial leadership, enhancing marketing and clinical capabilities and expanding sales coverage where appropriate. These investments are intended to improve execution and delivery of our strategic priorities. And we will measure investment effectiveness by the growth, productivity and operating leverage they deliver. We have entered FY '27 with strong commercial momentum. While we do not currently provide formal financial guidance, we see a path to do so in the future. As we diversify into a broader range of clinical applications, we're building a procedural mix that should support more consistent and predictable revenue growth over time. We intend to allocate capital selectively maintain a strong balance sheet and improve operating leverage as the business scales. In FY '27, our focus is on the following key priorities: PMA submission ahead of this calendar year end. Presentation of the findings from the pivotal randomized control trial at the American Burns Association Annual Meeting in April, with a podium slot reserved. Commercial availability of SynPath in the U.S. outpatients this calendar year with additional market-appropriate sizes planned to launch later in FY '27, transition to our new manufacturing facility starting in the second half of FY '27, key pipeline and partner engagement updates and continued growth of NovoSorb MTX through the expansion into new markets and increased adoption in the markets it already serves. PolyNovo has strong foundations. We have a proven platform supported by growing clinical evidence, a portfolio of products with expanding global reach, scalable manufacturing and a strengthened financial position. The next phase is about converting a decade of clinical Trust into a larger, more valuable business. That means turning clinical credibility into broader adoption broader adoption into commercial scale and commercial scale into lasting remains. That is how our impact on patients and clinicians become long-term value for shareholders. My responsibility alongside the Board and the leadership team is to pursue that opportunity with drive and discipline. We will invest in markets, evidence and capabilities that create the greatest long-term value while remaining focused on measurable progress, operating leverage and cash generation. And we will continue to build PolyNovo into a tissue regeneration platform company capable of serving many more patients. On behalf of the Board and the leadership team, I thank our employees, our customers, clinical and research partners and shareholders for continued support. I'll now pass back to the Chair.

Thanks, Bruce. Okay, we'll move on to some questions, I expect. For clarity, online attendees can submit questions at any time. To ask your questions select the Q&A icon, type your question into the text box. Once you finish typing, please hit the send button. Please note that while you can submit questions from now on, I will not address them until the relevant time in the meeting. Questions may be moderated or amalgamated together if we receive multiple questions on 1 topic or theme. If we run out of time to answer all your questions, we will answer them in due course via e-mail. To ask a verbal question, please follow the instructions written below the broadcast on your screen. While shareholders have their questions and/or make their way to the microphones in the room, we will play the second part of Sam's story. [Presentation]

I will now open it up to the room for general questions. Shareholders joining us in person today are invited to make their way up to the microphone at the front of the room. Please introduce yourself. We are keen to hear from as many shareholders as possible. So please keep your comments and questions concise so we can accommodate as many shareholders as possible. Shareholders are welcome to return to the microphone should they wish to ask further questions.

Amy, are there any questions online?

Thank you, Chair. Yes, there are a few questions that have come through online. I'll start with this one. PolyNovo has educated the market that it is a sales-driven company and that profits will follow sales. It has lost all blue sky evaluation through a complete failure to develop any new products over the last 12 years. To exemplify, PolyNovo has successfully built a global sales and distribution network for its products including BTM and MTX and is continuing to increase its revenue lines each year. However, while our flagship products carry an exceptional 90%-plus manufacturing gross margin, PMV statutory net profit margin sits at a relatively minute 4.9% with no sign of improving as maintaining and increasing the sales run rate currently demands and increasing human capital footprint of over 300 personnel. Can the Board please provide a clear operational road map detailing how it plans to leverage PolyNovo sales force to scale our statutory profits without a such imposing proportional increase in variable corporate and operating overheads?

Thank you for the short first question. Thank you for the shareholder presenting that question. It's a good question. We have an invest to grow mantra. We expect to be a fast-growing company commercially. We have, as Bruce very articulately outlined, a number of elements that build into that. One is our commercial team executing directly. One is our platform and one is getting better and better at our capability. And within that, growing our profitability over time. But we are balancing that around invest versus dropping to profit. Reminding everyone, our growth in FY '26 was about 21% in constant currency. Our EBITDA -- underlying EBITDA grew about 50% and we generated $9-plus million in free cash flow. So those fundamentals are doing well. But to your point on people, our people costs grew only about 4%, so we're outstripping our profit and our sales growth by some margin. And our corporate and admin costs actually dropped slightly. There's a whole lot of reasons for that, but they did. So our people costs barely moved and our corporate costs and admin costs were fairly much stable. So our overall mix of metrics was compelling. We'd always like a bigger return. But overall, a very strong set of results, particularly as we generated strong cash, we paid off our remaining debt, and we effectively funded our our operations center or our factory build and we've only got a remaining about $1.5 million to pay out on that CapEx. So we're in good shape in that respect. We're growing well. We could be growing better and our mix is looking solid.

Thank you, Chair. I'll give you a short one this time to balance it out. Will you move to quarterly trading updates in the future?

As Bruce said, we can see ourselves going to quarterly updates at a point in the future. We're not at that point. We still have a significant percentage of our business that is burns related burn incidence is variable. And whilst that continues to be a substantial part of our business, and it's lessening as we grow MTX, it will lessen as we grow SynPath and the like. It's still quite a variable journey in terms of consistency of sales performance. So we see a quarterly guidance element to our business as we mature but we're not there as yet.

Thank you. PolyNovo has no debt, strong cash position and a new manufacturing facility. Is there a possibility of a small dividend at the end of the 2026 financial year? PolyNovo had no debt. As you mentioned, cash of $35 million, $23 million operating cash flow and manufacturing expansion mostly complete. With no new expansion or opportunities being outlined that require significant capital, is there a possibility of a small dividend this year?

I guess the first answer is that the Board and management take capital management very seriously. And our view to dividend is at a future event. It's not a near-term event that we can see today. So now to the answer to your direct question online. Thank you for the question. We have a strong focus, and I think we need to be doing more in terms of our ability to add to our portfolio, to add to our research and development spend over time and to be funding our growth without having to go to any form of capital raise as well. So our mix is generating the ability to grow at pace, and -- but we are very committed to investing in that growth. Dividend is a nice thing to think about, but not yet.

Thank you. Can and will CRS start to be released to the market at the time of PMA submission? Can the data then be used to support entry into the large Japanese market? Japan seems to be a little urgency to the company.

Good question. I think I'll get Bruce to answer that, if you like.

Sure. I'll give you a break. So as far as the launch of the -- I'm sorry, a submission for PMA, we plan to release high-level findings from the study. The actual study will be presented, as I mentioned, at the ABA in April in Chicago. Let's say, for market entry into Japan, that would be a key element of that evidence package required for registration, although we're also going through a detailed business review of the value of Japan and the ability to generate profitable, sustainable revenue in that market. So looking at the reimbursement landscape is a critical part about joining a new market, and that's where we're at now. So -- but the study results would be part of that submission, yes.

And as Bruce mentioned, they'll be formally presented at the American Burn Conference in April, which we're looking forward to and the headline results shortly when we announce PMA submission.

Thanks, both. Both MTX entry into Europe and SynPath into the U.S. seem unduly delayed, is the stated emphasis of the new Board around disciplined execution, diligence and process coming at the cost of in action?

It's a valid observation in some ways. The the production and the development team have been and the quality and reg team are being very focused on PMA and putting a lot of resource into getting that right, and that's getting close, as Bruce covered. In terms of MTX, the pace of growth in the U.S. has been fantastic. I mean could it be more? Of course, it could be more, but it effectively doubled in FY '26. We're close to -- getting close to having the U.K. approval, and that's the journey we're on at the moment. And shortly after that, will follow with the EU pathway as well for MTX. And Bruce covered and I'll get him to add a couple of words to this as well, covered SynPath, so we will have first commercial availability inside this calendar year. Bruce, do you want to add to those?

Sure. We've learned a lot about the outpatient market over the course of this year. The key drivers for that business or that part of the market is very different from what you see in an inpatient setting. So reimbursement is key. We have a reimbursement code. That's not a problem. We have the product, not a problem. It's those clinical pathways that are part of in outpatients system as well as the site economics that have caused all of the turbulence within that market over this year, in particular, with changes in policy and reimbursement policies in January. So we have that pathway. We're working through the -- to ensure that as SynPath goes to market, it's more about the confidence of the provider that they will get reimbursed for that product. This is different to what we have in the hospital. So the confidence around the product, the confidence around having a reimbursement code is really steps along the way. The last step is making sure that we've got that local evidence that proves that a provider will get reimbursed if they use our product.

And I'll add to that, we've invested in a market access capability in our U.S.A. team to better understand and the deep dive or of that reimbursement journey. I mean they're really good with the SynPath journey for our business is today, we're not selling it. We will be shortly, but today, we're not selling it. And we sell within the hospital environment. I mean, Bruce mentioned some of the market or the addressable market opportunity can be measured in the many billions. We're not even in that space yet. But we do have a reimbursement path to understand better and to make sure we're well ready for that entry. What we're focused on is making sure we can leverage SynPath into the hospital environment in our first step. Amy?

What is the process from here regarding outcomes with BARDA?

Okay. I'll let Bruce take that.

So we have a development contract with BARDA at this point in time. It's been going for several years, linked to the pivotal study and the PMA submission once we go through that process as you go towards the approval and obtaining the approval, that relationship changed to a commercial contract. Working with BARDA, there's definitely separation between those 2 parts of the relationship. So as we finalize our development contract, then we start the process of a commercial discussion.

Thank you. Is our new production facility producing salable product yet?

No, it's not. It's -- will be -- it's very close. We actually enjoyed a walk-through of the new facility yesterday. It looks highly impressive. The team have done a terrific job building, commissioning and getting it ready to go, not quite go. Bruce, do you want to comment on the timing?

Yes. So building it is the easy part. So as you build the facility, then moving in all of the equipment, validating that equipment and then making sure that facility then is registered in all the countries that we sell. So going through that process, it will be a transitioning period. We've got 2 facilities now. This is the third, and we'll transition lines over really over a course of 12 to 18 months, it will take to get it all across when we start and we'll start in the second half of FY '27.

Okay. Thank you.

In news past, we were aiming to make India a huge customer base. It seems to be going well. But recently, it has become apparent that staff has been reduced on the ground. Can you please give us an update as to our prospects in India?

I'll give a couple of comments, and I'll get Bruce to pick it up as well. India continues to be a core market for the business. We have a direct team. We don't have direct teams in many countries. We have U.K., we have U.S. we have Australia and New Zealand, and we have India. And the pace of growth in our Indian business is strong. And it's been a bit of a journey of discovery understanding the intricacies of the largely tender-based market in India. But we see the pace of growth, and it's been published, the pace of growth continuing at a high level. Bruce, do you want to add to that?

Yes. Well, firstly, there's no reduction in the staff within India. It is a direct business as well as the way India works is that you work with multiple distribution partners as well to cover such a large land mass and population. That team and under the leadership that we have there has built a very solid business. In my experience, the work that has been done to build a strong foundation of not only a growing business but a compliant business that we can be assured to have sustainable growth in the long term. It's very important to me and to the organization. So we are seeing growth. It is acting as I would expect India to act. Tenders take longer for governments to release or hospitals to release. We are winning tenders that we started working on 3 years ago. So I'm very pleased with the progress of India. I see there's more progress to have -- and more importantly, we've got foundations of a sustainable business for the long term.

And as we published in our full year results, we grew the Indian business 53% last year or in the FY '26. Amy?

Another market-related question. What proportion of revenue in 5 years' time do you expect to be earned from non-U.S. markets? Do you have any specific targets for revenue in non-U.S. markets that you can discuss?

Specific targets 5 years out, no, we don't. We have a about 25% of our revenue comes outside the U.S. today. And you would think there'd be some sort of similarity to that as we grow, but the pie will grow. As Bruce covered with SynPath in particular, as we start to take that outpatient journey, and that's a very big market catchment. And if we can work the reimbursement piece, we see a upside in the U.S.A. coming over and above what we do in the hospital sector. But equally, a lot of geographies, japan has been mentioned earlier, India has been mentioned earlier. We're not direct in many countries. We have great partners in many countries, particularly, say, Europe, for example. The leadership team has done a very strong deep dive on our market strategy, our global strategy. And that's got a number of elements. Bruce has highlighted the sort of 3 key focus areas, but geographic spread will come when it makes financial sense and when the market opportunity meets the investment required.

Yes, I just think as far as the ratio is concerned, I'm not fixed to a number on what that should be in 5 years' time. We've got, as we've mentioned, growth potential in the U.S. in now even more settings, but particularly in those complex weaned applications within the hospital setting. And so that growth trajectory in the U.S., also looking at going deeper into markets that we're already in, in the markets outside of the U.S. I think that is a path for us to grow. Selectively adding new markets now that have high potential rather than aiming for a number of countries we need to be in. So I could see them growing at a similar rate. So I wouldn't see that the ratio would shift as long as -- Leon mentioned, as long as that pie is growing fast enough, that's what I'm looking for.

And that's really the focus on the question being geography. But as Bruce also pointed out, we've got the whole platform element to come into our growth pathway, which will also become a part of our ratio of sales as we build outside our core current products. Amy?

Thank you, Chair. We also have a few questions relating to the NovoSorb technology itself. The first is, when is the Board going to commit to properly expanding the the PNB technology as a multi-platform, one, by properly scheduling in and committing to the pathway to commercializing such applications as hernia repair. Hernia has been touted as a very real application for many years now, but nothing has happened.

Yes. I think there's a valid criticism in the company talking hernia for a number of years and not coming to an outcome. I think it's important that -- and Bruce covered this in part with our new Chief Scientific Officer, onboard. We're resourcing and we're focusing with a lot of capability in our development pathway. We're very strongly committed to our product portfolio journey and Bruce has covered BTM, MTX, SynPath. But we've got to unlock a lot of what we do and what -- a lot of what our NovoSorb platform provides for us, and that will be some of it being in-house, some of it being external advisers, some of it will be advisory engagement. And some of it will be via us adding business development capability, which we don't have today as effective as it should be. So Bruce and Marta are actively targeting business development to be the outreach looking for how do we leverage what we've got in platform and bring it to third parties. Unlikely, much of that will be in our hands. It will be in partners or via licensing or the like. Bruce, do you want to add anything to that?

Well, I think you covered it well, Leon have -- the one thing I would say is that we have got a strong team in place. We've got a strong team in R&D. The output I've mentioned a number of times, I'm not comfortable with the velocity that we've had out of our pipeline. So how do we resolve that? So working through having a leadership now looking at, well, what is the process that is holding us back from moving these through the pipeline? That has been the focus since day one for -- actually before Marta joining, and I'm very confident with that progress. You can't see that visibly out. The only thing that we will be judged by is the output from that pipeline, and we know that, but building that strong foundation, building the process that lets us do this repeatedly and more and more with greater velocity, that is our focus.

Thanks, Bruce. Amy?

Given the diabetic foot ulcer trial demonstrated superior healing time with the use of BTM, what is PolyNovo's strategy to enter this market?

Yes. I think that's a slightly more complicated answer. The DFU was a very small-scale study, and we're very delighted to have it done. It was focused on the higher-grade diabetic foot type or ulcer type, not the lower grade, which is where lots of clinical applications are focused. It was not statistically significant, but the key finding was pace. And so we had a terrific outcome in terms of how rapidly BTM could impact. It's also pretty big change of paradigm for clinicians because whether it should be BTM or MTX will be for clinicians as they continue that journey to optimize and in the U.S., that could be SynPath as well. In terms of DFU, we've responded in part to that with in pass having a reimbursement code in the U.S., and that will give us access, and we see that pathway inside the hospital, including outpatients as addressable soon. Outside the hospital, we need to think pretty carefully because it's a very -- it's a multibillion-dollar market, but it's a complicated coding and funding and market access piece that we're working on outside of the U.S., we've got BTM and MTX in, say, for example, in Australia and New Zealand, and that's available to clinicians now. So we should be able to be leveraging that opportunity and soon in the U.K. Bruce?

Yes. All I would say is when you look at diabetic foot ulcers and the treatment of those cases in the U.S. in the outpatient setting, this is the specific area that caused concern and cause the policy to be adjusted by the CMS early in the year. And so this is not about product quality. We are very pleased with the results out of that study, and we think that as the mentioned, it's a single site. They suggest that there should be more study in this case, in this -- to add to that research. But it's the site economics that we spoke about as well as the clinical workflow, which is the challenge in the in the outpatients. It's having not only the reimbursement rate but incentive or reimbursement linked to repeat applications that is not applicable to SynPath or BTM as a product. So that's the evidence we've provided to CMS to make sure that they're aware of this evidence as well. But essentially, there's 2 elements of this, not only just the economics but also the clinical workflow that we're addressing in diabetic portal. So now in that outpatient setting, with SynPath, there are other procedures that we are perfectly aligned with a great example is skin cancer repair, particularly reconstruction surgery, where having a single application of a product fits perfectly with what is needed. So you'll see that is where we'll focus first.

Thank you, Chair. There are a couple of other questions, but they have now been addressed by the other responses provided by you and Bruce. So with that said, we might invite anyone in the room if there's any live questions, shareholders...