Medical Developments International Limited

Thank you for standing by and welcome to the Medical Developments International FY26 four-year results call. All participants are in a listen-only mode. If you wish to ask a question via the webcast, please enter it into the ask a question box and click submit. I would now like to hand the conference over to Mr. Frank McGregor, CEO. Please go ahead.

Thank you very much. Good morning, everyone. Welcome to today's investor briefing. for our FY26 full year results. I am Brent McGregor. I'm the CEO and I'm joined today by Anita James, our Chief Financial Officer. So today I'm going to share with you an overview of our results and the company's key achievements in the year and take you through our priorities for FY27. Anita will speak to the financials in more detail, after which I will give some closing remarks. And then, as usual, we'll have plenty of time for questions at the end of the presentation. So, on that note, why don't we jump to slide four and walk you through the key messages we want to convey today. So, in short, our strategy to grow Pentarox, it continues to gain momentum. And as evidenced by our results in FY26, we made some great progress. We delivered a solid financial performance with very strong cash flow generation. And earnings in both our pain management in Penfrox and in our respiratory segments were materially improved. And in that regard, free cash flow landed at $4.2 million. So Penfrox in-market demand, it continues to grow. and it continues to grow across all of our jurisdictions. But we achieved some really significant milestones in AFY 26. A significant one in Europe was achieving the approval for the expansion of the PANFROC syndication to children from six years of age, where it was prior, it was 18 years of age. The most recent approval was the second biggest market force, which was the UK, and that came in June. And speaking of which, our partners in the UK and in the other European markets have now launched their commercial plans to unlock growth in what is now a broader addressable market. So we are delighted by this approval, which frankly has been some years in the making. Now in Australia, we completed a health economics study. It's been mentioned before, and I hasten to add it was published yesterday. And it demonstrates that PENFROC's use in hospital emergency departments enables a whole department cost and operational saving compared to the standard of care. And this is important data that will support our commercial value proposition going forward. And we expect this momentum to continue with higher PENTROX demand in the year ahead. Now if we move to slide five, this is the usual slide which is meant to show give us the headline results for the year. And what are those results? We landed our group revenue at $42.6 million, which was a growth over the prior year of 9%. And this was driven by a strong performance in the pain management side, which is up 21%. Frankly, this more than offset the impact of what was ultimately soft demand in our respiratory segment, where the revenues were down 15%. Having said all that, EBIT and NPAT were both improved And a particular note, as I mentioned, was the free cash flow, which at $4.2 million was $5.8 million higher than FY25. So this is a strong result for the year that has ultimately increased our cash balances to over $21 million. Now, we move to slide six. And slide six is meant to walk you through the strategy milestones that we achieved during the year. So, as you know, our key priority is to accelerate volume growth for PenFrox while continuing to improve our margins. So, we're really proud of the progress we made in FY26 on several big initiatives that we expect to support increased adoption in our PenFrox business going forward. Now, this included a few things. The pediatric label expansion, I mentioned that earlier, which broadened the addressable market and strengthened the platform for future growth in Europe. Publication of the pediatric study data. We were always calling that magpie. That is what supported the label expansion. This publication strengthens our clinical evidence and our pediatric positioning. The health economic study that I just demonstrated in the cost and operational savings of PenFrox in a hospital EV setting, which supports the broader value proposition. Again, that's the publication that just came out yesterday. And we continue with real-world evidence generation including several studies assessing the benefits of Penfrox in the emergency setting. Lastly, I would add the extension of the PBS eligibility here in Australia for eligibility for Penfrox to nurse practitioners. That was to physicians, now it includes nurse practitioners. So this is all in addition to the ongoing efforts of our commercial and medical teams who continue to work ceaselessly to strengthen clinical engagement and to support increased adoption. And And part of this effort includes representation at key scientific congresses throughout the year, like the Australasian College for Emergency Medicine, the Council for Ambulance Authorities, and the Australian College of Nurse Practitioners, to name a few. Now, look, we've said this before and I'll say it again. You know, we recognize that changing long-held behaviors in favor of a well-regarded product like Pentrox, it's taken time and it takes targeted effort. And so when I look at that and against that backdrop and looking back at FY26, really encouraged by the progress we're making. Now, in terms of margins, we implemented several targeted initiatives here as well. So in July last year, we increased Pantox pricing in Australia to those customers that had not received a price increase in FY25. And this delivered a $1 million benefit to our earnings for the year. Now, in other markets, we continue to implement pricing strategies that enable us to have a routine pass-through of inflationary movements as the opportunities arise. Can't do it everywhere, but where we can, we do it. In Europe, we finalized our transition of supply in France and in Switzerland to new partners. So, just a reminder, our partner in France is Edifarm. Our partner in Switzerland is Labatech. And both those partners made encouraging progress in in-market sales since taking on the marketing and sales of Pence Rocks in FY26. Now, having said that, while our margins in these countries are now lower, insofar as we now go through partners, this transition is enabling us to reduce our cost to serve those markets and is expected to accelerate product penetration in those markets over time. Finally, from a margin perspective, pricing in our U.S. respiratory business was increased And this was done to help mitigate the impact of the tariff regime that was affecting our business there. Now, speaking of the respiratory business, I mentioned at the start, the year was not without challenge. Our business faced a number of market headwinds, resulting in softer demand, particularly in the U.S. But despite all of that backdrop, we have reported higher earnings in this segment versus prior year. So, overall, a strong year that has yielded very encouraging progress in our strategy and our overall business. Now, on that note, let me move to slide seven. These are our priorities for FY27. Firstly, we're going to continue to work on initiatives to accelerate penetration of Pentrox in our existing markets. Now, this includes, of course, working with our partners to help unlock value from the pediatric label in Europe. leveraging the health economic analyses to drive faster adoption through our commercial strategies, and continuing to work on generating real-world evidence. Now, this growing bank of evidence will be critical to influencing that behavioral change and product adoption that I've mentioned before. Now, secondly, we're going to start to work on strategies to grow Panthrox in new markets and segments. Now, with several key milestones achieved in FY26, we believe we have the capacity and the confidence to push our boundaries further in FY27. So our ambitions now turn to discipline growth in new markets and segments, and I'll provide a little further color on the following slide. And then finally, maybe it goes without saying, but we say it anyway, we're going to continue to work to enhance margins and deliver operational efficiencies over the year. Okay, so let's go to slide eight. And this is a bit more of a drill down on those priorities I was mentioning. So, as I mentioned, we're going to continue our efforts to accelerate PENTROX growth globally, and this is going to include a few things. We're going to look at targeted entry into select new markets with a primary focus in Europe initially. We're going to do an evaluation of the potential to further expand the indication in Europe to procedures. Just expanded the indication to pediatric age. We're going to look at further expanding into procedural settings. And then we're going to do an initial assessment of growth potential in regions outside of Europe. So our learnings and our experience, the real-world evidence and data generated, it has applicability in all global markets, particularly in the hospital segment. What we have seen is there's, relatively speaking, a common adoption rationale for pentroxin hospitals globally, and particularly when supported by a pediatric indication, which we now have. Now, to deliver value from geographic expansion, that requires a few things. Very thoughtful market selection, identification, of course, of an ideal partner, and a go-to-market strategy with that partner that's deemed to be efficient and timely. Now, we have existing regulatory approvals in select markets. The decentralized procedure, the DCP framework in Europe, established partnerships, And through all that backdrop, that may offer efficient market entry and potentially accelerated penetration when we determine those markets that we want to pursue. Now, while opportunities that can leverage our existing platform and relationships will be prioritized, as I mentioned, evaluation of new market expansion opportunities and new partnerships will remain a focus. But we're going to keep you updated on progress in the year ahead. So on that note, let me hand over to Anita, and she's going to walk you through our results of the past year in more detail. Anita.

Thank you, Grant, and good morning, everyone. The results we've released today reflect good momentum in our PEMSROC strategy. The financial results are pleasing. Despite some headwinds in our respiratory segment, we have reported improvements in most metrics. On our top line, we delivered 9% growth, with revenue at $42.6 million. Pain management was up 21%, mitigating the impact of lower revenues in the respiratory segment, which was down 15%. Overhead cost management was strong. While we had some adverse impact from FX, EBIT and NPAC were both improved on the prior year. Moving ahead to slide 11 in our pain management segment, Revenue for this segment was up 21% with higher volumes and improved pricing in Australia. In Europe, revenue was up 12% to $9 million. This included growth in in-market volumes of 18%, a timing benefit of $1.2 million relating to partner stocking in the period, offset by lower transfer prices in France and Switzerland following transition from direct supply. In-market volumes were higher in every market. Volume in the UK and Ireland was up 20%, France was up 11%, and the Nordic region was up 19%. In Australia, revenue was up 16% to $17.9 million. Volume was stronger, up 9%, with the hospital segment up 28%, and the ambulance segment modestly improved. The Victorian government's decision to make Penthrox free for IUD procedures within its women's health hubs also positively impacted demand. Average selling prices in Australia were improved with the pass-through of FY25 PBS pricing to the remainder of the market, delivering a $1 million benefit to revenue and earnings. In rest of world markets, revenue was up strongly at $4.1 million. This included higher underlying demand of 13%, and a favourable timing benefit of $1.1 million from changes in partner stock holdings. Segment EBIT was strongly improved at $9.4 million, reflecting net volume and pricing benefits and disciplined cost management. Overall, a very pleasing result. Our respiratory segment on slide 12 had a challenging year. Revenues here were down 15% with the benefit of higher pricing in the US, more than offset by softer demand in most markets. Pleasingly, we were able to respond to softer demand and adjust our costs and stock levels accordingly. This, plus a refund of US tariffs, lifted earnings higher than the prior year, which was a great result. Moving now to slide 13 and the key changes to EBIT in the year. The strong contribution to earnings of our Penthrox strategies is clear on the chart. Higher in-market demand for Penthrox in all markets delivered an improvement to earnings of $1.8 million. This was the benefit from underlying growth in use of Penthrox. In the year, we also received a benefit from an increase in partner stock holdings. While this resulted in a $1.1 million benefit to earnings in FY26, It is unlikely to repeat in FY27. Higher average Pensox pricing, mostly in Australia, improved earnings by $1.1 million. Offsetting these benefits was the impact of lower transfer prices in Europe following transition to partner supply of $1.4 million and the impact of lower demand in our respiratory segment of $500,000. Other costs and revenue changes increased earnings by $700,000. This included the refund of U.S. tariffs of around $400,000, reduced commercial investment in the U.S. respiratory business, and lower amortization, which more than offset higher investment on Penfrox commercial initiatives and inflationary impacts. The net change in foreign exchange gains and losses in the period was $2.5 million. We had a loss of $0.9 million in FY26 compared to a gain of $1.6 in the prior year. Excluding the FX in both years, EBIT was improved $2.8 million, a great result. Moving now to slide 14 and cash. We are very proud to report free cash flow for FY26 of $4.2 million, $5.8 million improved on the prior year. Operating cash flow was strong at $5.8 million, up from a break-even result in the prior year. This included an improvement in our underlying cash earnings of around $1 million and favourable changes in working capital of $5.2 million. This included a reduction in working capital of $2.2 million in FY26 compared to an increase of $3 million in the prior year. The reduction in working capital in FY26 relates to timing of sales to our international partners and a reduction in inventory needs in our respiratory segment due to softer demand. Our working capital metrics are strong and are where we expect them to be. So we do not expect a similar improvement in working capital to benefit cash flow in the year ahead. CapEx in the year was slightly lower and cash at the end of the period was $21.4 million. Disciplined financial management and improved operational performance over the last two years has strengthened our balance sheet. With confidence in the underlying business and greater understanding of our growth opportunities, the company is assessing a range of capital management alternatives to maximise long-term shareholder value. This will include investments in our manufacturing facilities to support our growth ambitions, in addition to the expansion opportunities that Brent has spoken to. That concludes my comments on the financials. I will now hand over to Brent to close.

Thanks, Anita. So we move to the final slide, slide 15. So just to conclude, once again, we're proud of our progress in FY26. We delivered a solid, strong financial performance, and we've made meaningful progress in our strategy. And this progress provides a strong foundation for future growth. So looking ahead, accelerating PENTROX adoption remains key. So in FY27, we expect higher in-market demand for PENTROX, certainly supported by the pediatric indication in Europe. as well as the recently published health economic data that I mentioned. We intend to see stable demand in the respiratory segment in FY27. At the same time, we're going to have a non-recurrence of Pentarox inventory stocking benefits that we reported that occurred in the first quarter of FY26. We're also going to have in FY27 an amortization expense of approximately a million dollars and that's related to the capitalized registration costs for the European pediatric indication. I think the last point I would make as well, the impact to earnings of Middle East supply chain disruption, on one hand, U.S. tariffs on the other, remains a level of uncertainty for us, and needless to say, we are going to continue to be monitoring both of those aspects as we go through the year. So that's the close. I want to thank you all for coming on the call today. Now let's open the floor for questions.

Thank you. Once again, if you wish to ask a question via the webcast, please enter it into the Ask a Question box and hit the button. Your first question comes from Michael Hullewand from Hullewand Consulting Associates who asks, Given the publication of the health economics study in Australia, are any researchers in Europe expressing interest in testing the findings in a UK or France setting to see if the economics translate to that setting?

Yeah, it's a good question. We certainly anticipate this is what can follow on when we talk about real-world evidence generation. So the quick answer is, at this point, we don't have that expression of interest yet. By the same token, our partners are well aware of the study. Our partners are being provided with the study. Sorry, I just lost the question on the screen. Our partners are being provided with the study, and we anticipate and expect that there will be further real-world evidence generation that will occur in those markets. The last point I'll make on that question, though, is we intend in FY27 to generate real-world evidence here in Australia to continue the trajectory of that study. So the study's been completed. As you'll note when you see it, very credible, very highly reputable authors of the study as well. And we intend to pull that through and to partner with hospitals here in Australia to translate those study results into real-world evidence here too. So in addition to working with our partners to generate that interest there, we are moving forward with generating that real-world evidence here.

Thank you. Michael Loser asks, You don't break out Australian Penthrox volumes between paramedicine and hospital setting, but can you give some indication of the hospital volumes, just so we can understand the significance of the volume growth rate?

Yeah, look, the hospital growth has come from a small base because, as you know, the majority of Penthrox usage in Australia has historically been the ambulance services, and it continues to be that. And so we continue to work closely with all the ambulance services to ensure a continuing support on the manner by which they use PENTROX and have used PENTROX for a number of years. The hospital setting, we grew to 48,000 units in the hospital setting in FY26. So that's what the growth rate is predicated on. So it is from a smaller base. But we're very pleased with the growth rate that we generated in the hospital setting. We intend to continue on that trajectory going forward.

Thank you. The next question comes from Andrew Tan from Bell Potter, who asks, what are the possible initiatives under consideration for capital management? Is there a view on what proportion of the $21.4 million of net cash is surplus to your requirements?

Yeah, Andrew, I'll take that one. Good question. Really, in order of priority, we obviously need to invest in the business and our manufacturing capacity, particularly to support our growth ambitions. So that's priority number one. Number two is the growth opportunities that Brent spoke to, which includes both geographic expansion and and the indication expansion opportunity in Europe, both of which may require capital and they are continuing to be assessed. Within the geographic remit, obviously, there is the US remains there for the company. I will hasten to add, though, that our focus is very much on quota and less risky expansion opportunities, but But reassessing the US at the appropriate time is obviously something the company will look to do. Outside of that, and once we've assessed that, if there is capital surplus to requirements, we'll obviously look at whether that's appropriate to return to shareholders if that delivers the greatest value.

Thank you. Your next question comes from Matthew Cook from Cashbook in general who asks, Can you please provide a breakdown of the costs that are included in the other overhead segment and explain the large increase year on year? Given the significant size of this cost base relative to segment operating earnings, has the company given consideration to realizing this value by selling the business to a third party who could take advantage of synergies by eliminating these overheads?

Good question Matthew and it's probably not necessarily clear in our financials but the greatest movement there is in fact those FX gains and losses that I spoke to. So last year we had a gain of $1.6 million and this year we had a loss of $0.9 million so the turnaround of that looks quite large and that's predominantly the reason for the movement in that segment.

Thank you. Your next question comes from Cecilia Smith, a personal investor, who asks, could you unpack the specific impact that headcount changes and your broader cost discipline initiatives had on the FY26 results?

Yes, Ophelia, I'll talk to that. Maybe Brent might want to opine on that. I don't think there's any specific initiative in FY26 that has fundamentally changed our cost base. You might recall if you followed the company for a little while back in 24, early 25, we did undertake a range of efficiency initiatives that delivered benefits. I think the way that we're running the company now is just one of discipline. and taking opportunities where they arise, but certainly FY26 didn't necessarily have any particular step change initiatives, more just really robust and strong cost management.

I'll just add to that, I think from a headcount perspective, we made a few changes over the past year, and I think perfect to what Anita was saying, this is part and parcel of how we continue to view what our needs are going forward over the next two to three years. And so, you know, coming back to that core theme about prudent cash management, cost control, these are decisions that we take with a clear view of what we want to accomplish over the next two to three years and what are the needs we have in order to achieve those goals. And so some of the headcount changes that occurred that weren't many, some of them were fairly, you know, big at the leadership team level, for example. But it was looking at it through that lens that those decisions were taken.

Thank you. The next question is from Morgan Payne, who asks, Payne Management EBIT increased about 50% to $9.4 million, but group EBIT was only $0.2 million. As Penfrox continues to grow, how much operating leverage should shareholders expect at group level?

Yeah, that's a great question, Morgan, and really speaks to the opportunity in the company that we have through growth in volumes. Pay management as a standalone business is really strong. Obviously, the overheads and other activities to support that are clearly not fully leveraged based on our results to date. And that's where we will see that improve going forward as we do increase volumes. where we'd like that to be, certainly double digits and above at a point in time.

Thank you. Your next question is a follow-up from Cecilia Smith. Is there any sustained trajectory with ambulance growth in FY27? Any marketing initiatives to drive the growth?

Yeah, I'll take that. We look at the ambulance, it's our foundational business. It's our foundational business, frankly, around the world, the ambulance sector here in Australia. It's already highly penetrated, as you know. We see a trajectory of small single-digit growth in the ambulance sector, generally speaking. To your point about any marketing initiatives that drive the growth, we're always engaged in finding ways to support, from a marketing perspective and otherwise, the ambulance services. I would add one thing which is more from a I would say a medical and evidence generation perspective than marketing initiative per se and that is we are working with the university here in Australia and exploring a protocol to generate evidence to show the cost benefit of the use of PenFox in an ambulance setting. So I've talked admittedly on a few points during this webcast around the recent publication that shows that cost benefit, that whole of department cost benefit in the hospital. We want to look at something similar from an ambulance setting as well. So that's something that we have on the books and we have as part of our objective in FY27.

Thank you. There are no further questions at this time. I'll now hand back to any closing remarks.

Okay. Well, look, first off, first off, thanks so much for the question. We do appreciate that. We do appreciate your interest in the business Obviously, we hope that what we've been able to convey to you today is how good we feel about our performance in FY26, and how we also feel that is a platform for our continuing growth into FY27 and beyond. So on that, and on behalf of Anita, on behalf of all the team here at Medical Developments International, we thank you all for being on the call, and have a good day.

Thank you. That does conclude our conference for today. Thank you for participating. You may now disconnect. Thank you.