Thank you for standing by. Welcome to the Medical Developments International FY 2024 full year results. All participants are in a listen-only mode. There'll be a presentation followed by a question and answer session. If you wish to ask a question via the phones, you'll need to press the star key followed by one on your telephone keypad. If you wish to ask a question on the webcast, please enter it into the ask a question box and click submit. I would now like to turn the conference over to Mr. Brent MacGregor, CEO. Please go ahead. Thank you, good morning, everyone, welcome to today's investor briefing for our FY 2024 full year results. I am Brent MacGregor, I'm the CEO, and I'm joined today by Anita James, our Chief Financial Officer. 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 some drivers of our future growth. Then after I've done that, Anita will speak to the financials in more detail before I make some closing remarks. Today's release is in line with the results we shared with the market at the end of July, and at the time of announcing an AUD 10 million capital raise. As mentioned, there'll be plenty of time for questions at the end of the presentation. We'll skip past the disclaimer slides. We'll move straight to Slide Four. These are our key messages for the presentation today. Our financial results for FY 2024 are encouraging. We've delivered strongly improved margins, earnings, and cash flow. Our group revenue was up 3%. We're not as excited about that, our margins were improved by 5 percentage points. Our underlying EBIT was improved by AUD 7 million, our free cash flow was improved by AUD 10 million. Following the recent capital raise, we, we have a well-capitalized and a strong balance sheet with cash on a pro forma basis of close to AUD 19 million at this stage. Regarding our strategic growth initiatives, we have made good progress in the year. We've grown Penthrox volumes in key growth markets here in Australia and in Europe, our respiratory revenues in the U.S. are up over 30%. We've transitioned to a more efficient operating model in Europe, and the successful clinical outcome of our MAGPIE study in children provides the potential to expand our addressable market into the future. We expect this positive momentum to continue in the year ahead or in the current year. Let me provide a little more detail now on the coming slides. On that, let's move to Slide Five. These are the strategic and operational highlights of FY 2024. In FY 2024, we set ourselves five strategic priorities. Four of these priorities are included on the slide here, and on these we made great progress. First, we targeted a step change improvement in margins through pricing and efficiency, and we have achieved this goal with over AUD 7 million earnings benefits realized. This includes a reduction in costs in Europe, supply chain efficiency and higher pricing for Penthrox, and that's particularly in Australia. Our gross margin, as I mentioned, improved 5 percentage points, and our costs were reduced by AUD 5 million. Now, operational efficiency initiatives overall that we implemented in FY 2024 are expected to drive a further AUD 3 million-AUD 4 million or so in a reduction in costs in FY 2025. Now, as for our second priority, this was to increase penetration of Penthrox in the Australian hospital market. And on this front, the group delivered over 30% growth in volumes into this segment, with growing demand from emergency departments overall. From a small base, I grant you, but 30% growth nonetheless. Some of the lead indicators, Penthrox has been listed on protocols in 44 new hospitals, and the total number of purchasing hospitals has increased by 68 over the last year to a total of 244. These hospitals, of course, include major trauma centers in Melbourne and in Sydney, and in the period, Penthrox was also listed on the South Australian Medicines Formulary for use in emergency departments. Another encouraging outcome. Our third priority was about establishing an efficient operating model to support the growth of Penthrox in Europe. Europe is the largest market for Penthrox outside of the home market here in Australia. When you look here, costs to serve were significantly reduced in FY 2024, and during the year, we transitioned to what we're referring to as a capital-light operating model, and we scaled down in-market promotional activity. At the same time that we've done that, we are continuing to advance negotiations with partners for Penthrox distribution in France and in Switzerland. Additionally, the successful clinical study outcome of our MAGPIE study was a highlight of the year. Future regulatory approval of our submission of this clinical study data has the potential to accelerate growth in Europe. An expansion of the approved age indication to children would expand the addressable market and could also address a barrier to Penthrox's entry into some ambulance trusts in the U.K. We are hopeful to gain regulatory approval in select European markets by August of 2025. A further highlight we announced back in July, was the extension of our agreement for distribution of Penthrox in the U.K. and Ireland with one of our most experienced partners, Galen. Support from Galen over the coming years will be invaluable in realizing the potential of this expanded age indication that I just mentioned. Our fourth priority you see here, was to continue to grow our respiratory franchise. Our key, our key target market here, is the U.S. It has been for the past three years, it continues to be. Here we delivered for the third consecutive year, very strong growth with revenue in FY 2024 up 37%. Lastly, and it's not shown here on the slide, the fifth priority for FY 2024 was to advance U.S. market entry. On this, we did make some good progress in the year, particularly learning progress. In October, just to go back a few months, a number of months. In October, the group had a positive meeting with the U.S. FDA, where we gained a lot of clarity on the clinical pathway to U.S. market entry. From this, we have been able to develop more fully our estimates of project costs and timelines. We announced in April 2024, however, that following further evaluation of resourcing requirements and funding options to progress these plans, that we would pause the commencement of the next phase of investment in favor of focusing on our underlying business. Now, aligned with the delayed commencement of further U.S. market entry activity, investment in the group's next-generation device was also paused. We referred to that as Selfie in our past presentations. Now, despite this pause, the group remains confident that an attractive commercial opportunity exists for Penthrox in the U.S., and we intend to recommence plans at the appropriate time. To summarize, a lot of work in FY 2024 has created positive momentum for the company that will continue in the year ahead. Speaking of the year ahead, let's move to our growth drivers in FY 2025 in greater detail. The next few slides, we shared them in our capital raise presentation a few weeks back, but I feel it's important to step through these again because they will underpin our continued momentum, not only in the year ahead, but in the longer term as well. Let's go to Slide Seven. Thank you. Margin improvement is going to continue to be a strong focus for us going forward. Now, our target here is to achieve margins that fully reflect the value proposition of Penthrox in all markets. In FY 2025, we're going to benefit from efficiency initiatives that we undertook in FY 2024. That will drive a further AUD 3 million-AUD 4 million in earnings benefits in FY 2025. We will also benefit from further pricing improvements. On this point, here in Australia, the PBS accepted an increased pricing for Penthrox, which has resulted in a 25% lift from the 1st of August of this year, so already a few weeks back. Where appropriate, we intend to adopt this increase in other parts of the market to align with that PBS pricing. Lastly, speaking of pricing, we will benefit from improved pricing in the U.K. and in Ireland. If we move on to Slide Eight, this is about the Australian Penthrox market, and FY 2024 gave us a lot of good insights into the opportunity for Penthrox in the Australian hospital segment. As I already mentioned, we have made good progress with over 30% volume growth and strong lead indicators, such as those new protocol listings and an expanded list of purchasing hospitals. Certainly, the positive attributes of Penthrox were amplified in the past year, which confirms that the value proposition of the product remains very strong. We have really concrete evidence that demonstrates that once Penthrox is established in an institutional setting, it embeds as standard of care. We are seeing increasing interest on this point. We're seeing increasing interest in other procedural settings like O&G. Not surprising, in fact, considering the growing emphasis on pain management in women's health. In fact, there was a story, I mentioned it a few weeks ago. I'll mention it again here. There was a story, it's probably five, six weeks ago now, about Penthrox's use in the O&G ward at Frankston Hospital. It's such an example. The use of Penthrox in Canada, and the target of our partner in Canada, is another example. What we've also learned, though, and especially in the hospital setting, is that changing long-held behaviors in favor of a well-known and regarded product like Penthrox still takes time and a targeted effort. In short, ED physicians will need to hear more from peers to shift their behavior toward Penthrox over time. Addressing how to influence and shift behavior will be a key focus of our strategic efforts in this year ahead. That brings me to slide nine and the revised approach we're taking in FY 2025 as part of what we call our acceleration strategy. Now, our plan in FY 2025 will be to pivot away from a conventional field-based sales approach toward a stronger medical engagement strategy in the hospital segment. Now, this strategy, again, aligns with our capital-light approach, and it reflects a key learning of the past year, where behavioral change in ED has been slower than anticipated. We have some examples that are very encouraging, such as the Austin Hospital here in Melbourne, where use of Penthrox has been steadily increasing as a reminder of what our product can become in these settings. We know from our FY 2024 experience that there is a belief in Penthrox in the hospital ED, and our medical engagement approach will facilitate the building of an expert network in Australia that can establish advocacy in key institutions and facilitate this behavioral change we're talking about. Now, this approach will also be fueled by the MAGPIE pediatric data, which will serve really as the basis upon which these engagements will occur. A broader arsenal of evidence that can fuel the medical engagement approach will be required over time, in fact, the recent capital raise provides us with some funding capacity to address these needs. It is important to note, as well, though, that the benefits of progress in Australia is not actually confined to Australia. Progress here will be leveraged in support of our partner efforts in international markets, not just those we're in now, but those that we will seek to enter some point in the future. Speaking of international markets, we switch here to Slide 10, which reflects, of course, another key growth driver for our business in FY 2025. Our success in other markets, particularly in Europe. I've already spoken of our positive outcome with our partner in the U.K. and Ireland. This extension that I mentioned, and at enhanced terms for MVP, is a testament to the enduring belief in Penthrox and its growth potential. This relationship is now in its eighth year in the U.K. and Ireland, and our partner continues to be keen to leverage the growth of Penthrox with the MAGPIE data, to unlock even further growth in what is actually our second-largest market worldwide. This includes in the ambulance segment, where some of the largest trusts in the U.K. have been reticent to adopt Penthrox until the age indication captures younger kids. Just as a reminder, the age indication is at 18 years of age, and with the MAGPIE data, we're looking to lower it to as low as 6. Lastly, we also anticipate successful partner outcomes in France and in Switzerland to continue this growth trajectory for Penthrox in Europe. Lastly, of our growth drivers, you look here on, on Slide 11, and I want to say a few words about our respiratory business. Our growth of this franchise has been at a 30%+ CAGR since FY 2021, driven primarily by our focus in the U.S. market. In fact, that figure you see on the right here is 80% when you look solely at that U.S. growth. We've been very successful in building our presence in the large and attractive U.S. spacer market. We've made considerable headway in the retail pharmacy sector, and there remains a lot of upside potential here when you consider that we have not yet penetrated the two largest retail pharmacy chains in the U.S., that being CVS and Walgreens. Our strategy remains focused there, and we anticipate this trajectory to continue in FY 2025 as we push into institutional settings like hospital networks and group purchasing organizations. Okay, on this point, let me hand over to Anita, who's going to walk you through our results of the past year in more detail. Anita? Yeah. Thank you, Brent. Good morning, everybody. Just moving ahead to Slide 13. Well done. As Brent mentioned earlier, there are no surprises in today's results. They are in line with the unaudited results we shared with the market in July, aside our capital raise. Just to recap on the headlines, though. At the top line, we delivered 3% growth, with both pain management and respiratory up slightly on the prior year. A deeper look at the moving parts of our revenue line provides some insights which illustrate really good progress in our strategy, and I'll go through those shortly. As Brent has mentioned several times, we have had great success in FY 2024 in improving pricing and reducing our costs. This has resulted in strongly improved margins and earnings. Our gross margin has improved 5 percentage points to 74%, mostly due to higher pricing, particularly in Australia. At the same time, we reduced our cost base by close to AUD 5 million, and underlying EBIT was improved by AUD 6.6 million, up 36%. You will see on this page AUD 21.5 million in underlying adjustments in the period. These are outlined in further detail in the appendix. They include non-cash asset impairments we announced to the market in July, in addition to a one-off share-based payment expense relating to changes to Brent's remuneration, which we announced last November. These were also non-cash and did not represent a benefit to Brent. Net loss after tax was a loss of AUD 41 million. This reflects not only the underlying adjustments, but also the derecognition of tax losses that we announced to the market in July. Further details on this is contained in our financial report. Jumping ahead to Slide 14, and pain management revenue. Revenue here was up 4%, with strong growth in Australia and Europe, offset by lower revenues in our rest of world markets. This is due almost entirely to inventory stocking done in the prior year in Canada, ahead of the relaunch of Penthrox there. Pricing in the year was strongly improved, delivering over AUD 2 million in revenue growth, and we saw underlying volume growth in most markets outside of Canada. The Nordic region had a particularly strong second half, with positive momentum and demand building there, and France has been really pleasing, growing volumes despite limited commercial activity during the year. In our respiratory segment, we saw revenue growth of 1%, a solid result given the soft seasonal conditions we experienced in Australia and the destocking we experienced in Europe, driven by another really pleasing result in the U.S. Here, revenues were up 37% as we continued to grow market share. While our result in Australia was down on the prior year, it is generally in line with FY 2022, which was more comparable to the demand conditions we experienced in FY 2024. We hold a leading market position in Australia, and while overall demand was softer in FY 2024, we maintained our position in the market. Overall, a good result. On Slide 16, we have our EBIT bridge for the period. As Brent has already mentioned, we were pleased with the pricing and efficiencies we delivered. Pricing increased earnings by AUD 2.2 million in the period. This reflects price changes for Penthrox in Australia and some of our rest of world partners. Efficiency benefits, as I mentioned, improved earnings by AUD 5 million. This included costs, lower costs in Europe following the scale back of direct marketing support, supply chain efficiencies, and other operational efficiencies implemented throughout the second half. Volume changes I spoke to earlier had a net AUD 0.2 million benefit to earnings. Other cost changes and revenue changes were AUD 0.8 million at unfavorable to earnings. This included non-capital project costs relating to the operating model review in Europe and the U.S. market entry work in the first half, lower milestone income following a true-up in the prior year, and generally, general inflationary impacts. On Slide 17, our balance sheet and cash flow. In line with improved earnings, operating cash flow was strongly improved and CapEx was well down. Free cash flow, as a result, was improved by AUD 10.2 million. What has been most pleasing throughout FY 2024 is the trajectory of our cash flows, which continue to trend positively, reflecting the efficiencies we have delivered and overall underlying operating performance improvement. Cash at the end of the period was AUD 9.7 million. Following the raise on a pro forma basis, cash reserves were around AUD 19 million. Our balance sheet is well capitalized. CapEx in the year ahead is expected to be around AUD 2 million, so a step down from this year due to the completion of the MAGPIE study and a pause in investment in U.S. market entry activities. Operating cash flows are expected to be positive by the end of FY 2025. I'll hand over to Brent now to close. Thanks, Anita. Let's go to the final slide here. In summary, you know, we expect the positive operational momentum of the business to continue in FY 2025. We've delivered AUD 7 million in earnings benefits from pricing and efficiency already, and as I said, we expect to deliver a further AUD 3 million-AUD 4 million in FY 2025. These improvements will really drive delivery of our target of positive operating cash flows by the end of FY 2025. Finally, to our earnings outlook. The company expects underlying EBIT in FY 2025 to continue to be strongly improved on FY 2024, driven by higher average Penthrox prices and operational efficiencies of AUD 3 million-AUD 4 million. That's it in a nutshell. Thank you for coming on the call today, and now we can open the floor for questions. Thank you. If you wish to ask a question via the phone, you'll need to press the star key followed by the number one on your telephone keypad. If you wish to ask a question via the webcast, please type your question into the Ask a Question box. As there are no phone questions, we will move straight onto the webcast questions. The first question is from Dan Hurren with MST Marquee. What is the sales impact from a new hospital protocol listing for Penthrox? Do sales follow on quickly or does it take more time? Can you give any examples? Yeah, thanks for the question, Dan. It, I think the quick answer is it doesn't come quickly. The selling cycle is, is a long one. It varies from hospital to hospital. If you looked at the if you look at the steps, from the moment a protocol is written and approved, what happens next from a selling cycle perspective is that we look to train up the ED staff on the protocol and on the use of the product. That takes time to schedule, to get done. The hospitals are usually very open to doing it, even once the training is done, there is still, you know, time taken before behaviors really begin to change. The training happens, then usually some months pass after the protocol stage has been reached. Again, it varies from hospital to hospital. No two hospitals, at least from what we've seen thus far, no two hospitals are the same. It can be several weeks to a few months after the protocol is, is, is achieved. The next question is from David Parkinson, a private investor. Have you any idea how the tests in the USA are going? I'm sorry, could you repeat the question again? Have you any idea how the tests in USA are going? I'm sorry, I'm missing a word there. Did you say tests in the USA? Tests. I, I think perhaps they're referring to perhaps the notion that we have a trial going over there at the moment, Brent, which we don't. We don't have a trial underway right now, if that's what you're referring to. Sorry, if I'm not understanding your question. We're not in phase III. We don't have pre-clinicals going. As regards Penthrox in the U.S., that project is on pause right now. Sorry if I'm not getting if I'm not hearing your question correctly. Please ask again if I didn't get it right for you. I have two more questions from Dan Hurren. Can you explain how the additional cash will impact FY 2025 expenses versus FY 2024? That's the first one. Yeah. Morning, Dan. Dan, at this point, you know, our, our, our outlook for FY 2025 is for AUD 3 million-AUD 4 million of efficiency, so costs to come down by 3%-4%. We still, our outlook is for strongly improved earnings. In terms of changes to that, obviously, that reflects where we're at and reflects the fact that we've, we've been successful in the capital raise. The capital raise and the, the use of funds that we spoke to, July and August, alongside that, was around accelerating progression of the strategy in Australia, and that, that would take spend in various, various forms, including investment in data generation, expansion of commercial activities in time. But some of that work, necessarily requires progress in other parts of our strategy that we have underway at the moment, particularly in our medical strategy. That is likely to take some time in this financial year, and we're probably unlikely to be in a position until somewhere into the second half for that work to actually inform our next steps and our next investment stages. Unlikely to change our outlook for FY 2025 at this stage, Dan. The second question is, EU pain growth slowed in the second half. What is the outlook for FY 2025? Is second half the right base from which to grow, or will sales continue to fall to a new baseline before returning to growth? That's an interesting one, Dan. Yeah, there's a couple of data points for Europe, which you might be looking at. One is, we report underlying in-market volume. Yes, the growth% rate relative to the first half growth percentage was softer. We also report Australian dollars. The Australian dollars we report are not in-market sales. They are invoiced shipments to our customers, and that can be necessarily a little lumpy. Probably the best focus is the in-market volumes. Mm-hmm. To that, there's a few swings and roundabouts by, by country, but what we can say is that, that we're continuing to grow volumes, and see volume growth in, in, in all markets there. I think take an average, perhaps, across the year might be a, might be a better, better look. Next question is from Morgan Payne with Payne Media. On the last call, management said there would be no need for a capital raise. A raise was announced within three to four months from that call. What changed in these three to four months to go from no raise needed to needing AUD 10 million raise? Yeah, this was. There was no raise needed, and there was still no raise needed for us to hit positive operating cash flow. We had a number of discussions at the board level, Morgan Payne, around a few things, one of which was the our strategy and the acceleration strategy that we were contemplating. Another was around how the market was reacting with our share price, and as a result, we ended up taking a discussion and having advice, which said, let's move forward to do a small raise that allows us potentially to fund some additional initiatives we were contemplating, and it shores up the balance sheet a little bit further. This is not a raise that's been required, to achieve positive operating cash flow, as we've said, and we continue to hold to that view. The next question is from Roy Taouk from MST Marquee. Given the price increases in Australia generated AUD 2.2 million in FY 2024, what will the new 25% price increases in Australia in August 2024 generate in FY 2025? Hmm. I'll stick. Anita, do we have this figure specifically? Oh, look, it, it again, will be, a AUD 1 million-AUD 2 million impact. Yeah. Roy. The PBS price specifically is on PBS volumes, which obviously is not all of our volumes. That will be an automatic pass-through of pricing, and that's effective from the first of August. We will look to leverage that to push pricing more broadly in the market, and anticipate some of those benefits to come through in FY 2025, and further benefits to come through in FY 2026. Up until now, there's been no, w ell, there's been no impact on, on the behavior on, certainly ambulance services and our customers in Australia. It's still early days with the latest price increase. We've, our teams had a number of discussions with key customers, key partners in Australia, to you know, as to the rationale for the price increase, recognizing that there was an increase as well about a year and a half, 18, 19 months prior. We believe quite strongly, and we believe our partners in the market also believe strongly that the price does reflect the value that, that Penthrox represents, and we were encouraged by the fact that from a PBS perspective, that the government felt that way, too. The next question is from Murray Hewitt with Ord Minnett. Hi, Brent and Anita. Given that the introduction of Selfie may help drive adoption and further market penetration, what time and capital amount is likely required to finalize development of Selfie and bring it to the market? Yeah. Hi, Murray. Selfie is still in a, it's in a late stage on the engineering front. There are still a few more steps to take. We put Selfie on hold because we link it very closely with U.S. market entry. Why is that? Because our internal view currently is the cost of goods associated with Selfie, is higher than the cost of goods associated with our current device. Hence, it's probably likely, a U.S. market device. We'll see whether it ends up being a device in other markets, including here in Australia. In terms of how much additional cost is associated with getting it to the finish line, that's not a number we're super clear on right now. Anita, do we have a number that's associated with the remaining effort required from an engineering perspective on Selfie? Not a definitive one. I don't think so, yeah. Murray, Selfie is in a pause, just as the U.S. project is currently. Next question is a follow-up question from Morgan Payne. Can you give more information on the results and submission of the MAGPIE in the UK? Sure, Morgan. The MAGPIE study was a study, a pediatric study. The purpose of the MAGPIE study was to ultimately lower the age indication from its current 18 years down to six years of age. Ultimately, what MAGPIE was intended to show was that the efficacy and safety profile at that lower age is equivalent, at least, to what it is at the adult age, at 18 years and above. That's what the MAGPIE, that's what the results have shown. So, we have that dossier, that dossier read out a couple of months ago. The publication is close at hand, but one of the things we said, Morgan, a few weeks ago, during the capital raise process, was that we would be submitting that dossier to the European authorities on August 14th, and that occurred on that day. We are into the process now. What we're gonna wait on next is when the first round of questions comes in the normal course. That should come probably somewhere around October. Usually, it's one and half to two months after a dossier is submitted when the questions begin to come back from the regulatory authority. Our ability to respond to those questions in a timely manner is gonna be important. We're very focused on that, we expect to get a positive result from the European authorities in August of 2025. Another question from Morgan, how long can the FDA approval be paused for? How long can it be paused for? Yes. It can be paused, it can be paused indefinitely. We have an open IND, so we do need to maintain interaction with the authority such that the IND remains open. But it can be paused for an extended period of time. We don't have a timeline right now on when we will re-engage the U.S. project. We don't intend that it's gonna take a number of years, but it's not gonna occur in FY 2025, at the very least. We'll have to figure out what the funding options are for us, because these will be the preclinical studies that would have to be done before we go into phase III. Thank you. There are no further with press questions. I'll hand back to you for closing remarks. Okay. Look, everyone, thanks very much for coming on this call. We know for a number of you, it's a bit repetitive, from the calls we've had over the prior weeks during the capital raise process. We do appreciate you coming on the call this morning, and we appreciate as well, you asking the questions that you asked. We're really encouraged by what the platform that we're on right now. We're encouraged. We've already had kicked a few goals in the first, you know, few months of this year, so we're feeling good about the progress we're making, even as we come to the end of August. We look forward to speaking to that a little bit more. I suppose the next milestone will be the AGM in October, and then, of course, the half-year results. Until then, I thank you again on behalf of all of us for coming on the call, and wish you a good day.