Thank you for standing by. Welcome to the Medical Developments International FY23 full year results conference call. All participants are in a listen-only mode. There will 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 the one on your telephone keypad. 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. Gordon Naylor, Company Chair. Please go ahead.
Good morning, everyone, and welcome to today's investor briefing for our full year financial results. I'm Gordon Naylor, Company Chair. I'm joined today by Brent MacGregor, our Chief Executive Officer, as well as Anita James, our Chief Financial Officer. I'll make some introductory remarks and then pass over to Brent and Anita, who will run you through the slides. There will be plenty of time for questions at the end of the presentation. This financial year has been one of consolidation for Medical Developments. Following the successful capital raise a year ago and completion of the primary investment phase, we're very focused on managing the cash resources of the company. France was a difficult decision to make, but management acted appropriately to adjust course. Our other markets are developing well, with strong sales growth across both the pain and respiratory franchises.
This is a pleasing result following our efforts to focus the business and build capability. Even though we've excluded it from the underlying results, I would also commend Brent and his team for stopping the clinical trial in China. This was burning cash without any realistic prospect of a commercial outcome. A careful resolution of the situation has also preserved our strategic optionality in this region. In addition to improving financial performance, strategic efforts are mainly directed toward U.S. market entry. With this in mind, I'm very happy to welcome Dr. Russell Basser to the board. Russell brings a great depth of experience and expertise in the U.S. clinical and regulatory environment. These capabilities will be invaluable to the company as we thoughtfully progress toward U.S. market entry.
Finally, we've worked very hard through the year to strengthen our governance systems for the company and to better align management incentives with the interest of shareholders. We'll have more on this at the AGM. Over to you, Brent.
... our key achievements in FY23. After I've done that, I'm gonna hand over to Anita, and she'll take you through the group financials in more detail before returning to talk to you. I'll return to talk to you about our FY24 priorities and our outlook. As Gordon mentioned, we'll be very happy to take questions at the close of the presentation. Moving to, first to slide three. We're very proud of our achievements in FY23 and the progress we are making in delivering our growth strategy with our lead Penthrox business, as well as with our respiratory franchise. Now, over the last two years, a key priority has been to build the capability in the company needed to execute our growth agenda. I would say our capability build is essentially complete, and we are already seeing encouraging results.
I'm gonna touch on some highlights in the coming slides. We stated previously our target of delivering positive operating cash flows by the end of FY25, and this target remains a key goal with a step change in profitability expected ahead. Later in the presentation, I'm gonna take you through some of the key initiatives that will deliver this change. Entering the U.S. market for Penthrox remains our longer-term target, and market entry here represents a significant value creation opportunity. Our plans are advancing, and later in the presentation, I will share with you our expectations for the year ahead, as well as some exciting insights we have gained on this value opportunity. I feel the company is now at an inflection point, and I'm proud of the progress we've delivered to date, and very excited about the opportunities that we have ahead.
Now, moving to slide four, these are the financial highlights of the period. As a headline level, we delivered revenue of AUD 32.3 million in FY23, which is a growth of 47%. As you see here, the breakdown is a 54% growth in our Penthrox business and 43% growth in the respiratory business. Our underlying EBIT loss is AUD 18.3 million. Finally, our net loss after tax is AUD 5.6 million, which has actually strongly improved over the prior year. This included a gain from underlying adjustments of AUD 10.3 million before tax, mostly related to, as Gordon mentioned, the closing out of our clinical program in China, as well as costs that were associated with the commercial assessment that we did for Penthrox in the U.S.
Overall, we've increased the penetration of Penthrox in global markets, and our respiratory segment is reflecting the gains we're making in growing market share, particularly in the U.S. We're very encouraged by the progress we're making. If we advance to slide five, I'll walk you through some more of the operational highlights. As I said, we made some encouraging progress in our commercial strategy to increase the penetration of Penthrox and to grow share in our respiratory segment. Here in Australia, we deployed a field team to capture the growth opportunity for Penthrox in the hospital emergency department, as well as to continue driving further penetration in existing segments. Our partner markets for Penthrox have also performed well. We saw good growth and underlying demand in Europe. We expanded our market reach with the relaunch of Penthrox in Canada.
Early feedback from this market has been very positive, and we're looking forward to seeing continuing growth as we go forward. Now, in France, we delivered Penthrox volume growth of 33%. This was encouraging, but it was less than our expectation, considering the investment we've made in that market. Our progress was slowed as well by challenging conditions across the entire healthcare system in that country. In light of these market conditions, we've decided to scale back the spend, and I'll speak to this later in the presentation. Our focus on growing market share in our respiratory business has delivered great results once again. Sales in the U.S. were up 59%, mostly on share gains, a very pleasing outcome, overall. Now, longer-term growth for Penthrox will be accelerated by things like label expansion, new product development, and most importantly, U.S. market entry.
We have several initiatives underway across all of these. We've also been undertaking a trial in the U.K. It's been underway for a couple of years now, specifically focused on demonstrating the safety and the efficacy of Penthrox in children. We are pleased to report that this trial is now closed. Our submission is expected in the year ahead. Ultimately, we hope to see an outcome that will reduce the age indication below 18 years of age in Europe, thereby expanding our addressable market. We'll keep you informed of progress. We continue to work on our next generation Penthrox inhaler, which we call Selfie internally.
We're proud of as well, that we've been selected to get the funding of up to AUD 1.5 million under a program called the Clinical Translation and Commercialization Medtech Program, otherwise known as CTCM. This is to support investment in this device over the coming two years. Selfie, as you may recall, is critical to our U.S. market entry plan. Finally, as previously mentioned, we have advanced planning for entry into the U.S. market in earnest, and I'll talk to that further later on in the presentation. Overall, an encouraging year for the business. I'll speak to how we will continue the momentum after Anita's taken you through the financial for the full year in more detail. Anita?
Thank you, Brent. Good morning, everyone. Firstly, to recap on the headlines of our FY23 performance. Revenue was up 47% at AUD 32.3 million, with Penthrox and Respiratory performing well, by volume and price. Underlying EBIT was lower, at a loss of AUD `18.3 million, with higher gross margin and investment in commercial leadership functional capabilities that is underpinning the delivery of our growth. Underlying adjustments were a net gain of AUD 10.3 million, which mostly reflects the cessation of clinical trial preparation in China, which we announced in our first half results, and costs associated with the comprehensive commercial process for Penthrox in the U.S. Further details on adjustment can be found in the appendix to the presentation and our financials. Reported EBIT and NPAT were strongly improved for good state adjustments.
Moving ahead to revenue in our pain management segment on slide eight. Our top, top line performance for the year illustrates good growth for Penthrox. Revenue in the pain management segment was up 54%, with a very strong second half, which included the recognition of a shipment to our U.K. partner that had been deferred from the first half. Pricing was improved, with increases achieved across all products in Australia by the end of the year and in several partner markets. Volumes in all markets were up. In Europe, demand was stronger despite economic challenges. European in-market volumes were up 39%. This included growth in France of 33% and 34% in the U.K. and Ireland. Volumes in the Nordics, Central Europe, Switzerland, and Belgium were also up. In Australia, volume was up 6%.
This reflected solid demand from the ambulance sector in growing penetration in emergency departments and procedural segments. Volumes into other markets were up almost threefold, driven by inventory stocking for the relaunch of Penthrox. Moving ahead to slide nine and our respiratory business. Revenue here was up 43%. Strong results that reflect freezing market share gains, particularly in the U.S. Strong partner engagement, solid underlying demand. Inflationary pressures were managed well through disciplined pricing. Overall, encouraging results. Moving ahead to slide 10, the key changes in underlying EBIT in the period are reflected here. Firstly, we have expanded gross margin. Higher volumes and improved pricing increased gross margin by AUD 5.4 million, with increases of the same for respiratory segments, a very encouraging result.
Secondly, we have invested in capabilities to deliver our growth ambitions, which included AUD 3.4 million for commercial and marketing resources to drive the penetration of Penthrox in hospital emergency departments. AUD 1.2 million to underpin our growth in the U.S. respiratory market, and AUD 2.5 million relating to leadership and functional capability. As Brent mentioned, we have completed the capability build, and we expect to see our resourcing levels steady through FY24. Other cost changes impacted EBIT by AUD 1.9 million, including a one-off contract termination cost in France relating to our scale down in European resourcing and inflationary impact. We said at the time of the capital raise that we expected our investment to underpin growth in our portfolio and that we would return to profitability as our volumes and margins improved. It is encouraging to see progress this period.
Brent will speak to the improvement in earnings we expect in the year ahead. Moving ahead to slide 11, and our balance sheet and cash flow. Our closing cash balance is at AUD 25 million. Operating cash outflows in the period were AUD 17 million, reflecting earnings and working capital investments of AUD 2.6 million. Pleasingly, our working capital to sales % is in line with the prior year, with strong customer collection and good inventory management. Capital expenditure for the year was around AUD 8 million, which included spend on the development of Selfie, the U.K. pediatric file, and market registration activities in the U.S. and China. We expect spend in the year ahead to be approximately AUD 5 million. With spend on U.S. registration... Sorry.
Spend on U.S. registration activities will be limited to planning activities only, with funding of the clinical program to be supported by one or more partners, and Brent will give you more details shortly. I'll now hand over to Brent to speak further on our priorities and on the year ahead.
Thanks, Anita. We'll move to 13, now, slide 13 on our FY24 priorities. In FY25, we're going to deliver an improvement in earnings and cash flow, while continuing to advance our plan for U.S. market entry. These priorities are reflective of the competencies in our organization and our expectation that we will fully leverage this capability to deliver results. These results will come not just from commercial performance, but also from disciplined operation and efficiency that will drive needless costs from our operations. I'll provide a little more detail on the following slide. We move to slide 14 on pricing and efficiency, and our intention is to deliver AUD 6 million in incremental earnings benefits through pricing and operational efficiency. The further pricing improvements, mostly for Penthrox, are expected to deliver around AUD 2 million to the top line.
In line with our pricing strategy in Australia, we will implement further price changes from those implemented in FY23, and will benefit from a full 12 months of what was implemented last fiscal year. Beyond Australia, we are actively working on new pricing arrangements with partners in several of our global markets that we believe more accurately reflect the value of Penthrox. Operational efficiencies will reduce costs by around $4 million, and this includes, first off, cost savings in Europe. From July, direct promotional activity in France has been significantly reduced and regional management costs have been scaled back. Most activities previously managed in Europe will be managed through our team in Melbourne. We also have improved processes and capabilities throughout our supply chain, which will deliver savings in production, labor, and freight.
Of course, we intend to benefit from scale efficiencies as our volumes grow. These savings overall will deliver a step change in earnings for the business. Moving first to our Australian growth strategy, which is on slide 15. Our focus in this market is to drive our commercial effort into the hospital and procedural segments. The Australian market for Penthrox has historically been focused on the ambulance services. In fact, 75% of our volumes today are into this segment, despite the fact this segment represents only about 30% of the addressable market. Penthrox in the emergency department offers compelling advantages, including both patients and efficiency benefits. To support penetration here, we have deployed a field team to target the hospitals. We've enhanced our medical department to support access, and we've launched activities to position Penthrox in these settings.
Volume growth in FY23 reflected early progress in our drive to increase penetration. In addition, the team has made gains in working with hospitals and buying groups to list Penthrox on hospital formularies and to generate protocols in all states. In fact, we can say that 30 protocols now exist today that did not exist 12 months ago. From experience in other markets, we know the selling cycle can take several months, but with some early wins already made, we expect to see sales momentum accelerate in the year ahead. Moving ahead to slide 16, and the go-to-market model for Europe. As I mentioned earlier, our progress in France in the period was not as strong as we had planned.
While volume growth was 33%, that in and of itself is encouraging, the rate of growth was less than we had forecast relative to our level of investment. In light of operating conditions as well and slower than planned growth, spend in France has been scaled back, and this decision is very much about having an eye to our pathway to profitability. Supply to existing customers, which is a list that's now more than 300 strong, will be maintained through a scaled-down regional team with greater oversight from our head office here in Melbourne. Strong product stickiness, we'll call it, is expected to underpin stable demand as we revisit our go-to-market approach. I would say that the first two months of performance in France this fiscal year is in fact confirming this view.
Our approach going forward may include a partner-supported strategy that is delivering encouraging growth in the U.K., in Ireland, in the Nordics, and in Austria, and that assessment is underway. Our decision in France will also, of course, influence our approach in other European markets, including Germany, Italy, and Spain, and we'll provide an update on our assessment in the coming months. To the U.S. on slide 17. We're advancing our plans for market entry to the U.S., and we're taking a deliberate approach, as we've said before. This will ultimately be transformational for the company and is a primary strategic focus for the group. We have several streams of work that are underway. Firstly, a partner search.
The company announced in April it would commence a search for partner organizations to undertake the clinical and the non-clinical programs required for U.S. market entry and to launch Penthrox in this market. The U.S. is, of course, the world's largest market for pharmaceuticals, and it is clear that delivering value from Penthrox here will be best achieved through the support of one or more partners. An experienced advisor has been appointed to support the search for suitable partner organizations to fund the development program and ultimately to commercialize Penthrox. A comprehensive market assessment on the commercial opportunity for Penthrox in the U.S. was completed in the period, this assessment will inform partner discussions and development of the go-to-market strategy. I will share some of these insights from this assessment on the following slide. Secondly, in FY24, we're going to advance our planning for the clinical program.
We expect this to commence ultimately in FY25. We are continuing to work to simplify the phase III protocol as well as plan trial logistics. Finally, we're gonna continue to develop our next generation device. That's Selfie, as I've mentioned. This is an important stream of work, as it will be this device that we will use at launch, and we're assessing the possibility of also using the device in our clinical program as well. Now, let's move to slide 18. I mentioned about giving you some insights on the commercial assessment that we've done. Here are some of those high-level insights. Needless to say, the commercial assessment for Penthrox in the U.S. identified a large and attractive opportunity for Penthrox.
On the assumption of a label that launched similar to Europe, the study estimated an addressable market somewhere in the range of $300 million-$400 million, 5 years post-launch. This is based on an addressable market of 20 million adult patients in acute pain and trauma, with 75% of these patients in emergency departments and EMS segments. Pricing in the identified segments was forecasted to range between $35 and $75 per unit, depending on the segment. There's a further 10 million adult patients in outpatient procedures, as well as children, which could be reached in the future with label expansion. These estimates exceeded our initial expectations, and it provides us with confidence that the unwavering commitment of the company to pursue entry in the U.S. will deliver significant value.
This brings me to the final slide, which is our outlook for FY24. The company expects underlying EBIT in FY24 to improve on FY23, driven in three ways: higher Penthrox volumes in Australian hospital emergency departments, share growth in the respiratory segment, and incremental improvements, margin improvements of AUD 6 million from pricing and efficiency gains. As Anita mentioned earlier, we expect capital expenditure in FY24 to be approximately AUD 5 million. Our performance in FY23 has solidified our foundation such that we can continue to execute our strategy in a sustainable manner that increases our confidence to reach cash flow positivity by FY25. I'll stop there, and we'll open the floor for questions. I'm also being told we've had some issues with the audio, and apologies for that, but let's keep pushing forward.
Thank you. If you wish to ask a question via the phone, you'll need to press the star key followed by the 1 on your telephone keypad. If you wish to ask a question via the webcast, please type into the Ask a Question box. Your first question comes from Dan Hurren with MST Access. Please go ahead.
Good morning, and thanks for taking my call. Look, I was hoping we could just dig in a little bit more into France, and perhaps just on practicality. What did France look like before on the ground and what will France look like in the future, just perhaps in terms of numbers? Just perhaps anything you could tell us about what the cost impact will be of those changes?
Sorry, I even missed the beginning of your question due to the audio issues. I think we've got them corrected now, at least I hope so. You were asking, if I can read back to you, you were asking what the what the footprint was on the ground, what it is now, and what the cost saving is. Is that your question?
Yes, I'm just trying to understand, like, practically, what, what did France look like, what it look like in the future, and potentially what's that cost impact? Thank you.
Yeah, sure thing. What we had, what we had on the ground in France were 10 key account managers. They've all been moved off. We had a region team of four, which we've reduced to two, and the vast majority of the activities now, or a considerable amount of activities, are being managed from back here. We'd reached, we'd reached 65,000 units. You may recall from a year ago, we'd anticipated a higher number. It's a good growth, and as we've said, it's not- it wasn't good enough for the investment we put in. That cost goes away, and there's, What is it? It's around AUD 3 million-AUD 4 million of savings resulting from that move. We are well engaged in an assessment right now as to what steps we take next.
What we have, what we have built into our FY24 plan is to hold that business. That's what got built into our base plan for FY24, is to hold those 65,000 units through this, through this broader management, partly in Europe and fundamentally from back here in Melbourne, while we determine what we do next. We're in the throes of doing that assessment right now.
Understood. I, I guess, does this mean that France is now topped out, or will you seek a partner there in the future? What's the future there?
Oh, we, by no means is France topped out. I mean, France's move, we were, we finished 49,000 units at the end of FY23, FY22, or 65,000 FY23. We believe there's lots of potential, lots of headroom that's ahead in France. It's not because we think the French market is tapped that we took the decision. There are, there, there are market conditions I had mentioned, but we fully intend to engage in a very proactive way going forward in France. Whether that's a partner strategy or some other strategy, we've not determined yet, but we will come to a new strategy and continue to move forward in France.
Understood. I guess, thinking about it a little bit broadly, the, the direct-to-market model. I mean, you know, if you look at the Ramsay Health Care result, France has been a, just a shocking system. You know, does this invalidate the direct-to-market model, or is this, is this truly just bad luck on timing, and there will be direct-to-market opportunities in other, other geographies?
You know, it's hard to say. I don't think it invalidates the direct-to-market model per se. France maybe was a set of unique circumstances for us. It's a, it's a more challenging market in the main. Having said that, we went into France because there was a reasonable base of business when Mundipharma handed over the market authorizations. Nonetheless, we're taking all the lessons from that, and we are looking again at, you know, a company our size and saying, What is the best approach for us going forward? We are doing the direct-to-model, direct-to-market model here in Australia. Conditions, obviously, in this market are certainly different than they are in France. I wouldn't say it, it invalidates it, but I would say it's opening our view to other approaches that we want to consider taking.
Understood. I'll keep, I'll keep pushing my luck with two more questions. The AUD 6 million benefit, I had terrible audio, so apologies if I missed this, but that, that AUD 6 million benefit, that, that's kind of at an EBIT level. Is that what you're thinking?
Yeah. No, it is. It, it is at an EBIT level.
Understood. Okay. The last question, again, I might have missed it. You said earlier on in the call that you were gonna talk about timings around the U.S., and I, I didn't catch it, I'm afraid. Just, you know, the broad timeline of, of-
Yeah.
trials and product launch.
Yeah. I don't think it's your fault. I think that's ours. I think with the audio issues, sorry for that. Yeah. What we had said, what we had said on the presentation was, we expected to go into clinic, into the clinic, around FY25, and our current indication or our current projection on that basis would be around an FY28 launch, but that remains to be seen. As you can well imagine, it's very much triggered by when we go into the clinic.
Great. Okay, I'll stop popping the questions. I'll get back in the queue and come back at this time. Thank you.
No worries. Thank you.
Thank you. We'll now move to our webcast questions. Your first question comes from Paul Higgins, a private investor. What does the France scale mean... Oh, sorry. What does the France scale back mean for Penthrox in Europe? Will you pursue a partner? Mundipharma failed, and it now seems as though MVP's direct attempts have also failed. Will MVP ever launch in Germany and Italy, that were considered key markets?
Yeah. The... I think the... Let me look at that question again. Yeah. The scale back means, I think, as I said, I realize the questions may come because it wasn't clear when we were doing the presentation. The scale back for us means that the conditions that were ultimately in the market, combined with the effort we put in and the cost associated with it, were such that it wasn't a good spend for us. We've taken the decision to end that spend, what we're looking at now is, we're, we're well engaged in this assessment, we have been for a little, a little while now, is to, what's our best approach going forward? We're looking at France. We're certainly looking at Germany, which is, of course, the biggest market in Europe.
So much depends, of course, on if it's a reimbursable market, what that reimbursed rate is, and that, that figures in our thinking as regards to markets like Italy, like Spain, and elsewhere. So we're engaged in that assessment right now. Are we looking at a partner model? I know there's reference to Mundi. I think there's a number of different conditions associated with Mundipharma. What I would say is, we have a much clearer view of what the characteristics of the right partner for us is, and a very clear view of what we believe are, are appropriate terms that can generate economic benefits for MDI, MVP, as well as for a partner.
I feel very confident about our clarity on that internally, and we are engaged in looking at what our go-to-market model is gonna be, not just in France, but in the other European markets as well.
The next question is from Craig Aubel with Century Private Wealth. Did you say you expect profitability in FY 25?
Yes. Our plan, our plan and our approach is still that we will be operating cash flow positive by the end of FY25.
Another question from Craig: Is the U.S. market assessment of $300 million-$400 million revenue on a per annum basis?
Yes. Correct. That's what the study is telling us. Yes.
Our next question is from William Sharp, a shareholder. Why have you not yet secured a partner to move to the U.S.- U.S.A registration forward after four to five months of searching?
Well, just to clarify, we've not been searching for four or five months. We engaged an advisor, only in the last, in the last, month to, about 6 weeks ago, and so that search is actually formally beginning, during these, these final months of this year.
Okay, next question, another one from Craig. What products are manufactured in Taiwan? Has there been any progress in diversifying manufacturing factories away from Taiwan?
Yeah, the products we manufacture in Taiwan, our suite of, of, Space Chamber products are manufactured out of Taiwan, as well as the inhaler device, for Penthrox. We have been making progress in diversifying from one supplier. We have a second supplier, I think, for the device or, we're validating. We expect that diversification is gonna come through and we'll have a second supplier in place. It's not in place yet, but it will be.
Okay. Our next question is from Donald Berry. When will the share price increase?
Yeah, hopefully off the back of this call, but we'll see. We, we believe, we believe what we've just presented is something that's very encouraging. We, we feel as well. We feel very strong, confident in our view as to our, our path forward, the things that we've done, and hopefully, the market will see that as well.
Another question from Craig Aubel. In relation to cash flow, payments to suppliers and employees was AUD 46.259 million. Where do you see the FY24 and beyond?
Yeah, I'll take that. Not necessarily speaking to specific line items on the cash flow, but we do expect operating cash flow in FY24 to be improved, reflecting the improvements in earnings that Brent spoke to.
Thank you. You have a follow-up question on the phone from Dan Hurren with MST Access. Please go ahead, Dan.
Thanks very much. Sorry again, I'm positive I missed this, but just if you could talk more about the Selfie. It hasn't really sort of featured much in. Just, just timing, and how should we think about, I guess, pricing and gross profit associated with the Gen 2 versus the Gen 1?
Yeah, what we're seeing so far, I mean, we have a, We're still working on, because that, that development continues for Selfie, Dan, and we're working on having a cost of goods associated with that device as close as possible to the existing device. It is gonna be a little costlier to make, and so on the basis of that, we're evaluating the markets into which we believe, you know, we can, we can make gains come at a higher price, reflecting the increased value we strongly believe is represented by Selfie. That assessment is, that assessment continues to be underway. At a minimum, Selfie, the Selfie product will be the device with which we, we enter the U.S. market.
The development and the design of that device has been what it's been for quite some time, and as I said, we're focused very much on how do we get cost of goods down. I think there's two potential benefits for Selfie, Dan. One, of course, is if we can see an enhanced price for the product and the basis of that value. The other is, and this is the assessment we've been doing, is whether we can see more rapid volume uptake as a result of the ease of use of that product. I don't know if that answers your question or not.
No, it does. Thank you. Thank you. Perhaps just one more, the often overlooked respiratory segment. Really good volume growth, really good revenue growth there. I mean, there's been some discussion in the past. Do you still consider this a, a core part of your business? What, what will it take in terms of development to get it where you want it to be? Development cost, I should say.
Yeah, the core part of our business is, and will continue to be Penthrox. Respiratory has performed well. We have it. It's, it's, it's resourced in a very, I think, a narrow and manageable way, and we've been making good gains because of the targeted effort we've put to it. We continue to put, I, I would say, an appropriate amount of investment in respiratory relative to Penthrox. We see the contribution. I think everyone sees the contribution it's making. I think we leave open the optionality for us of what we do with that franchise as we go forward. We're building it up to being, I think, a, a, a real scaled business. It really wasn't that over the past, the prior two years or so, or, or even before that.
We like where it's headed, but our, our core franchise will remain, Penthrox.
Understood. All right, thanks very much.
Thank you.
Your next webcast question comes from William Sharp, a shareholder. Medical Developments have been talking about U.S. entry and registration for years. Why is progress glacial? When can we expect U.S. registration?
Yeah, I, I understand why you're asking the question, especially we got the hold lifted in March of 2022. Look, what I can tell you, William, is we're taking a very deliberate approach to this. I think in the past, we might have moved, the company may have moved very quickly, on some fronts, and we don't wish to do that here. It is taking time. I can assure you, it's not because we're not putting an immense effort, into getting it right. As we said, when we did the capital raise one year ago, we, we are, we are intending to have this funded in a non-dilutive way, and that remains our intent. It takes the time that, that it's ultimately taking.
I realize it's not a great answer for you, but the main point I wanna make to you is, we're not gonna enter, into the U.S. market and into the clinic until we're fully ready to do so. We're, we're heavily engaged on it, and we have been.
The next question comes from Steve Richardson with Bridges. When was Australian emergency team deployed, why was Australian growth so low compared to other regions? When can we expect the growth to kick in?
Yeah. The, the, the Australian team was deployed... It was toward the back end of last calendar year, so, you know, toward the end of Q2 FY23. I think once the training and all the preliminary effort was done to put them into the field, that really happened at the start of this calendar year, so Q3 of FY23. Those six individuals with a sales, with a, a sales manager, managing them and a medical team in support, they've been engaged fully, I would say, fundamentally, since January, February of this year. I mentioned, and you may not have heard, admittedly, I mentioned that there are 30 protocols that are now in place that were not 12 months ago.
Now, granted, a protocol does not automatically mean a sale, but what I can say is we are not gonna see unit uptake of Penthrox in the hospital emergency setting without a protocol. That step is well underway. Progress being made by that team. The last thing I would say is, we anticipate an accelerated growth in the Australian market this, this fiscal year as a result of all that effort and that continuing effort.
Another follow-up question from Craig Aubel. Do you anticipate having to raise funds again?
We do not. It's not our intention, no.
All right. There are no further webcast questions at this time. That does conclude the conference for today. Thank you for participating. You may now disconnect.