Good, thank you. Okay, well, the format for this morning is that Greg and Mary-Ann will step us through a short presentation recapping the highlights from what has been a very significant year for the company. Following the presentation, we will open up the floor to Q&A. If you would like to ask a question, you can do so by typing it into the chat function, which is in the ribbon at the bottom of your screen. We will ask as many questions as we can in the time that we have. I think we have until 12:00, so we will see how we go. For now, I will pass over to Greg and Mary-Ann, and they will take us through their presentation. Over to you both.
Well, thanks, Sheree. Mary-Ann, it has certainly been a very exciting year for Emyria. Lots of momentum behind psychedelics and psychedelic-assisted therapy, not just in Australia, but worldwide. How are you feeling about things?
Good. It has been a big year. I guess pulling this presentation together, you reflect upon what has happened over the year, and you sit back and think, gosh, a lot has happened, both within the organization, but as you say, more broadly, the momentum that is taking place globally.
Mm.
Which is great to see.
I think that is right. I think it is important to reflect on how much we have been able to achieve in such a small period of time. Really, for us, we keep saying it, this is just the beginning. We are just getting started. Maybe we will get into the presentation, Mary-Ann.
Great.
Just to recap for anybody who is new to the story, what are we doing? We are rolling out a national network of clinics specializing in the delivery of psychedelic-assisted therapy for two indications at the moment, for the treatment of PTSD and treatment-resistant depression using two drugs, that in 2023 were rescheduled from Schedule 9 prohibited substances to Schedule 8 controlled drugs. Two psychedelics in MDMA and psilocybin with street names of ecstasy and magic mushrooms. Australia was the first and remains, to the best of our knowledge, the only national jurisdiction worldwide to have created a regulatory pathway, a legal regulatory framework, which allows these treatments to be delivered.
I suppose it is important to reflect on, Mary-Ann, on why this has occurred. Clearly, there is an increasingly significant need for people suffering from mental health-related illness. Off the back of the clinical trials that emanated out of the United States, the TGA saw fit to change the regulations to allow these treatments to address this huge need and growing need within our population and indeed within the world population. It is also important to reflect on the economic cost that is being incurred by a range of different insurers, and entities.
Private health insurers are paying out an absolute fortune otherwise in mental health-related hospital admissions. The Department of Veterans' Affairs has got behind us and behind these programs because of the disproportionate representation of veterans within these mental health-related conditions. Then we have got life insurers who ultimately are paying out huge claims, a huge amount in claims, for permanent disability related to mental health. Clearly, there is also a health economic need to provide for, I guess, novel new treatments. It is important also to reflect, I think, that there have been no new treatments in the mental health sector for the past 20 or 30 years, something we wouldn't accept in any other sphere of medicine.
Mm. Particularly for PTSD. That's right. Thanks, Greg. Look, it's probably worth, I know a lot of you probably know our story, but just a quick recap in terms of what a patient journey looks like. So they come in for screening into, as Greg mentioned, it's a highly regulated industry through the Authorised Prescriber program, so a number of regulatory items need to take place. You go through a screening process to determine eligibility. If you're deemed to be eligible for the program, which is determined by the authorized prescriber, you then go into preparation, which is often preparing, one, for your active treatment protocol, but also tapering off any medication that you may need, two, antidepressants.
You then come in for your active treatment protocol. Now, that's quite a condensed timeframe, four to six weeks. Typically, three dosing days for PTSD treatment and two dosing days for treatment-resistant depression. A dosing day consists of eight hours. You come into the clinic in the morning, you sit in a room with two therapists for the day, and you take the medication, and then you come back for three therapy sessions over that fortnight, and you do it again. So it's really this condensed treatment protocol, which is unusual for mental health treatments. Then you go into a follow-up phase.
Now, real-world data collection is incredibly important for us, so it's an opportunity for us to, one, see how you've been responding after the active treatment protocol, but also for us to ensure that we can collect the appropriate data to continue informing and build the body of evidence. Big addressable markets here. 1.1 million adults in Australia suffer from major depression, and 1.5 million adults in Australia suffer from PTSD.
Now, in terms of what our clinics look like, we talk about bed capacity. We've got five clinics when our Sydney clinic opens up by the end of this quarter, two in Perth, one in Queensland, one in Victoria, and one in New South Wales. That will give us 18 operational beds, which means 90 dosing days per week. Each dosing day generates around AUD 10,000 of revenue for the company.
Now, this slide we put out a couple of months ago, and it effectively talks about the typical timeline to projected clinic profitability. So we say it takes around 9- 12 months to become break-even per clinic at a clinic level. So the first six months, we talk about as the investment phase. One to three months is around the clinic set up. You are out and you are recruiting your therapists. You need to have a significant workforce of therapists to be able to support the clinic. You are doing your fit-out, ensuring that the regulatory processes are in place, getting your psychiatrist their Authorised Prescriber status, and conducting in-house training. Then you move into opening the clinic and commencing the screening. Screening can be a good 6- 12-week process. So it does take some time for your dosing days to ramp up.
You can see there that Perth clinic is our most established clinic, and it is at break-even and profitability at a clinic level, which is great. Then this chart shows where Brisbane, Mornington, and Sydney are in terms of that timeline. Sydney is soon to be opening this quarter, and we put out some news this morning to say that it is on track for that to take place, which is great.
We have tried to capture everything we have done into one slide, so it is quite busy. But you can see that there has been quite a lot of growth. Revenue for FY 2025 was AUD 1.3 million, whereas revenue for FY 2026 grew quite substantially to just over AUD 4 million. Then there was other income and R&D on top of that as well, getting it more to close to AUD 4.3 million.
As July last year, we had one clinic here in W.A., but we have managed to now either open up or soon to have been opening up five. We have announced our fifth during the year, which has been a significant achievement for the organization, and we are now across the four largest states in Australia. We did have four operational beds, and we will be moving to 18 with Sydney coming on. Again, a substantial growth there. At the end of FY 2025, we had around 30 trained clinicians, and that has grown to having trained approximately 145 across Australia in those states to support our clinic establishment.
Then you will see we have gone from six Authorised Prescribers to 17. That is including the two that we announced this morning for Sydney, which is fabulous to see. It is important to have a group of Authorised Prescribers that can support each clinic as they open up. Then total patients treated. So by the end of FY 2025, we had treated 24, and by the end of FY 2026, we have either treated or are in treatment. There have been a cumulative total now of 138. Again, another large growth metric there.
In addition to, I guess, the clinic growth, the workforce growth that we are seeing, the Authorised Prescriber growth, we also saw the Medibank agreement being established and then going nationals to support both the PTSD program and the treatment-resistant depression program. This was very encouraging to take these treatments from what would have been deemed a little bit more fringe into more of mainstream. We also welcome the fact that the DVA announced that they would be funding these treatments for eligible members, which is good to see and positive.
And we also announced clinically significant results from both our PTSD programs. We put out results that were 12 months post-treatment. Of the cohort, we were seeing 76% had a clinically significant improvement, and two-thirds were actually no longer meeting the criteria for PTSD. We have also put out early treatment-resistant depression program outcomes, which demonstrate clinically significant results across depression scores, trauma scores, and an improvement in daily functioning as well.
We have also, in this period, launched our Empax Global Partnership Program, which helps us to be supporting drug sponsors globally who are developing their own treatments within this realm. We are already supporting a clinical trial. We are running it and being funded for it through our infrastructure here in Australia. We see it as another revenue stream.
Mary-Ann, these are outstanding results, clearly. Take us through why we need so many trained clinicians, for example. 145 sounds like a huge number of clinicians when you consider we have four operating clinics with a fifth coming online. Why is it that we need so many trained clinicians Australia-wide?
Yeah, good question, Greg. Effectively, our clinics are either three or four bedrooms typically, or treatment rooms. You can have one doctor operating on that day, or Authorised Prescriber, but you need two therapists sitting in each room. If you have your four rooms operational on that day, you need to have eight therapists. No therapist does this full time. No Authorised Prescriber does this full time. They do this as part of complementary to their other private practice that they may be operating. If you think about extrapolate that out, someone might do one, maximum two dosing days per week as a therapist. That equates to quite a few therapists that you need to support your clinic, as it is becoming operational four to five days a week.
I guess this speaks to the operational moat that we talk about in terms of how difficult it is to deliver this program and why we are not seeing competitors, particularly competitors at scale, entering the market. When you look at the length of time that it takes for a clinic to come up to profitability, it is understandable that you need a strong balance sheet in order to support a scalable model of this nature.
Yep. You are very right. Exactly. So look, before I leave this slide, I guess I am going to reiterate it really has truly been quite an inflection point for us this year, in terms of growth, not only in Australia. But the other thing that we have seen take place this year is a number of large pharmaceutical companies stepping into the arena of psychedelic drug development. We have seen acquisitions by Eli Lilly for close to AUD 3.8 billion to acquire AtaiBeckley . We have seen Johnson & Johnson coming in and funding another large drug sponsor. We have seen some other transactions as well.
So the global momentum is really starting to take off, including things like the executive order that was signed by Donald Trump earlier this year. Whilst we have been growing significantly here in Australia, and it is certainly with that first-mover advantage, it certainly means that we have the know-how and the skill set to deliver something that is not taking place globally. It is all in kind of clinical development globally. So it has put us in a really strong position to be the leader in this space.
Thanks, Mary-Ann. I guess we have got some core objectives upcoming. The first is to increase utilization within our existing clinic network. As Mary-Ann said, we will have a fifth come online through the Sydney clinic through the course of this calendar month. In fact, I think it becomes operational next week, does not it, Mary-Ann?
Yep. Hopefully.
That is an exciting inflection point for us as well. But increasing utilization is of paramount importance for us because clearly that will drive revenue and ultimately profitability within each of those sites. We will also look to expand our clinic network. We have a pipeline of clinics, it is fair to say that we are exploring currently, and we will look to start to increase the size of our network through the course probably of next calendar year now.
One of the things that we are addressing also is additional reimbursement pathways, and we have talked about Medibank Private a lot. We have talked about Department of Veterans' Affairs. One of the things we have not talked about probably as much is the ad hoc workers' compensation approvals that we have been receiving. Do you want to talk a little bit about that, perhaps?
Yep. That is a good point, Greg. Over the course of the year, we have certainly seen more workers' compensation insurers starting to approve case-by-case treatment for their clients and members. So that is really promising to see, and we certainly see that continuing to grow, as the education continues and the understanding of what these treatments could potentially do and the body of evidence that is growing. People talk about wanting to see this continued body of evidence, and I think in terms of how much research is taking place globally, as well as what we are able to demonstrate in our real-world evidence, that body of evidence is just kind of continuing to validate the potential of these treatments. So it is really positive to see those workers' compensation insurers coming on.
Great. We do not talk much about our drug development programs, but we have a library of MDMA analogs, and also a medical cannabinoid asset that we are allowing to tickle along, if you will, using non-dilutive funding. We have got a grant that is allowing us to progress our MDMA analog pathways. So that is something that we do not talk about much, primarily because we are clinically focused at the moment and do not want to divert from that task.
We are actively exploring jurisdictions outside of Australia. There is obviously a lot of momentum emanating from the U.S., and just over the weekend, we see that New Zealand has now created a pathway for PTSD treatment using MDMA. And I think psilocybin, they had already approved earlier last year. So to see that MDMA for PTSD has now been approved in New Zealand, it is very exciting. I guess further validation that these treatments are starting to become a more mainstream version of treatment throughout the world.
And of course, as Mary-Ann said, we want to grow the global partnership program, the Empax Global Partnership Program, because that gives us different revenue streams, but also the ability to start to help drug sponsors overseas validate new clinical indications.
Yep, correct. We are starting to see some interesting things take shape there. We often have a slide that we include in our presentations, which shows how many different research programs are taking place. I think there is over 100 clinical trials that are in the process at the moment. There is certainly a lot of work to be done in the clinical trial space.
Really, I think this slide just talks to some of that momentum that we have been espousing and highlighting as emerging, not just from within Australia but across the world. There is certainly a huge amount of momentum. The thing that we have come to realize, I guess, particularly when we talk to some of the large pharmaceuticals, is how difficult it is to deliver this treatment and how much of an advantage we have on the rest of the world. In fact, we think that we are probably the leaders worldwide in the delivery of psychedelic-assisted therapy. The learnings that we have gained, the regulatory hurdles that we have had to overcome, the experience that we have within our clinician network, it really does position us as the leader in this field. Anything else you want to say to that?
The only other thing to probably point out is in the U.S., there are two drug companies, one called Compass, who has submitted to the FDA for their psilocybin treatment for treatment-resistant depression. We understand that Resilient Pharmaceuticals has resubmitted their MDMA for PTSD application. So this is great forward momentum that is taking place over there and potentially looking for the first FDA-approved psychedelic treatment, and potentially by the end of this year. So that will be interesting to see.
Fantastic. Well, it has certainly been a terrific year. We are really looking forward to the rest of 2027. We are obviously into it already, and things are moving very quickly, and we will be bringing everybody a lot more news in terms of what is happening within Emyria over the coming weeks and months.
Back to you, Sheree.
Great. Thank you. Thank you, both. Lots of highlights from what's been a really busy year, including a 475% increase in patients treated, which is fantastic. Congratulations. I know there's been a lot of hard work behind the scenes. We'll now move to Q&A, and I do have a few questions that have started to come through. Just as a reminder, if you'd like to ask a question, you can do so by using the Q&A ribbon in the bottom of your screen. I'll just start with the first question. Are you happy with the progress you have made in 2026?
Well, I'll probably start off, and maybe Mary-Ann can take us through. We're incredibly happy. I think we're further ahead than what we imagined we would be. I think, and Mary-Ann can perhaps talk to the operational element and what we've been able to achieve on the ground here in Australia. I think for me, the thing that is most exciting is what's happening on the global front. We know that Australia was the first jurisdiction to validate psychedelic-assisted therapy as an alternative, if you will, to what we might call more conventional mental health treatments.
But the fact that this is being validated now worldwide, and there's so much push, there's so much momentum across the globe to see psychedelic-assisted therapy as a real treatment option for those otherwise suffering from very significant mental health illnesses with otherwise nowhere to go. I often talk about the merry-go-round that they get on where the music just never stops. We're looking to stop the music, get them off, get them back into the real world again. I think we're so far ahead of the rest of the world. That's what's so exciting for me. What about what stands out for you from an operational standpoint, Mary-Ann?
From 2026?
Yeah.
Yeah. Look, obviously going from one to five clinics and 30- 145 trained therapists is a lot of, as Greg said, a lot of work behind the scenes. We are really grateful for the team that we have that has been delivering this. There is no template. We are having to forge the way here. So I think in terms of where we have been able to get to, we are thrilled.
There are obviously things, this is highly regulated. There are things that are out of our control. Regulation is something that we navigate through all the time. So things like the TGA has now relaxed the lead therapist requirement. And that is one of the challenges that we have faced in terms of ensuring that we have enough of those. So we continue to recruit and onboard those therapists and navigate through that. But I think in terms of what we can control, it has been an incredibly successful 2026.
Great. Thank you. Another question. You mentioned that the announcement that has gone out regarding the Sydney clinic being on track for opening this year. Do you have an idea of how many more clinics you want to open over the next 12 months?
Well, I think I mentioned earlier in the presentation that we have a pipeline of clinics that we are looking at through existing and other partners. I think we have been pretty open in saying that in the first instance, we are looking to increase the size of our hospital partnerships, and we will open clinics within hospital networks. It is an easier way and a capital light way for us to roll out clinics at scale. We will look to make announcements in that regard probably over the next couple of months, I would say, Mary-Ann.
Yep.
Great. Okay. You did touch on the Empax Global Partnership Program. A question here around, could you discuss in a little more detail the benefits of this program?
Yeah. So, a couple of different angles here. One, we can utilize the infrastructure we have here in Australia. It is quite desirable for international drug sponsors to come to Australia to conduct clinical trials. Now, with the infrastructure we have created and the skill set that our team has generated, we can offer that to those drug sponsors, and we are already running a clinical trial at our site, to support a U.S.-based drug sponsor. We look to continue expanding that out to other clinical trials.
In addition to that, the other areas that we can look to support are around the commercialization. The delivery IP that has been developed is also strong, and Greg has spoken to the operational moat that we have developed. As these drug sponsors continue through to potential approvals, regulatory approvals, and commercialization, they need to shift their attention from how they are going to get that drug approval to how are they going to be able to deliver these treatments, and what needs to take place to scale that up. It is all well and good to have a drug approval, but if you do not have the delivery infrastructure in place, and the training, there is a huge amount of training.
You can just imagine how many therapists need to be trained in the U.S. to be able to support one drug treatment approval. These are the opportunities that we can also look to support through the Empax Global Partnership Program.
I think there's also a longer-term play here, and that is in terms of helping to validate other indications. At the moment, we've talked about the ability to treat PTSD and treatment-resistant depression because of successful clinical trials which came out of the U.S. As more successful clinical trials validate different indications, mood disorders, anxiety, eating disorders, drug and alcohol dependency. As different indications are validated against psychedelic-assisted therapy, we can see that we will be able to ultimately treat far more indications, far more conditions, far more mental health-related illnesses than we currently can. But using the same protocols, the same infrastructure. That's another exciting aspect of the Global Partnership Program.
Excellent. Thank you. Just another question here. If you had any updates in regards to securing another health insurance partner to fund treatment for its members in Australia.
Look, other than what we've said previously, which is we continue the discussions, getting case-by-case workers' compensation approvals. That's how workers' compensation works. They're not going to come and say, "Here's a big partnership." They just start approving them. We continue to work in this space, and look forward to being able to update the market further.
I think it's fair to say, though, that we've had ad hoc approvals from a variety of different private health insurers as well. So we've had ad hoc approvals from workers' comp insurers, workers' compensation insurers, but also from private health insurers outside of Medibank, which I think speaks to the fact that they are starting to look at funding these treatments more seriously.
Yep. That's a very good point, Greg. Yep. Exactly.
Okay.
We can see it as green shoots. The more varied the insurer is, so when you look at workers' compensation, there are many insurers that sit behind that. We've had a number of different insurers that start to commence these approvals. I think one thing we've talked to as well is just in terms of DVA, we're still working through that and what that looks like, but we look forward to being able to offer these treatments for their eligible clientele as well. In terms of reimbursement opportunities, there are certainly a number of them that we're working through and will continue to work through. It's one thing that we see as important as this industry stabilizes.
Yep. Okay. Great. Well, I'm conscious we're at 12:00 P.M., so maybe just one last question, which is probably a good one to finish up on. Looking ahead, what are you most excited about over the coming 12 months?
Well, we're probably going to offer different opinions on this.
Yeah.
But there's obviously the operational element in terms of increasing utilization within our existing clinic network, and then growing our clinic network, growing our footprint across the country. We want to make the Empax name synonymous with the delivery of psychedelic-assisted therapy, not just in Australia, but worldwide.
But I guess, as I said earlier, the thing that is most exciting for me is to look at what's happening on the global front, and to look at how we might be able to play a role in helping to further psychedelic-assisted therapies worldwide. Because I think that given the experience, given the length of time now that we've been involved in providing these treatments, we're better placed than anyone else in the world to be able to educate and provide understanding as to the significance of these treatments and the significant impact that they can have on patients.
Hmm. I think, certainly, I agree with Greg. I'm looking forward to seeing the clinics, as they continue to become established and bedding all of them down and looking forward to being able to create a more extensive footprint nationally so that we can ensure that there's an ability too, for those eligible, to receive these treatments.
And then, to Greg's point, you look at what's happened in the industry globally, just let's say since the executive order was signed in the U.S., that was in April. We're now at the start of September. It's a huge amount of momentum and positive steps forward, in this area. So I'm really interested to see. It'll be interesting watching back this webinar before we do the next one this time next year to see what's taken place. I think it's going to be a bit of a different arena yet again.
Excellent. Yeah. Lots to look forward to over the next 12 months. Well, I think that's all we've got time for today. Thank you, Greg. Thank you, Mary-Ann. I'd like to thank everyone for attending, and I'll now invite you to disconnect. Thanks a lot. Have a great day.
Thanks, Sheree.
Thanks, Sheree. Thanks, everybody.
Thanks, everyone. Bye.