Lumos Diagnostics Holdings Limited ($LDX)

Hello, everyone, and welcome to the Lumos Diagnostics investor briefing to discuss the Q3 FY '26 results that were lodged with the ASX yesterday. My name is Jane Lowe, and I'll be your moderator for this session. With us this morning we have Lumos Diagnostics Chairman, Sam Lanyon. I'll say good morning to you, Sam.

Good morning, Jane.

Also CEO and Managing Director, Douglas Ward, afternoon to you.

Good morning.

And also CFO, Barrie Lambert. Good morning, Barrie.

Good morning, Jane. Good morning, everyone.

Okay. So the format for today is that Sam, Doug and Barrie will walk us through a presentation that was released to ASX this morning, should take about half an hour or so. And after that, we'll follow on with a Q&A session. We plan to wrap up in about 45 minutes today. If you'd like to ask a question, please click on the Q&A tab in the ribbon at the bottom of your screen and type your question into the box provided. The webinar is being recorded today as usual. So with that, I'd now like to hand over to Doug, who will get us on the road. Thanks, Doug.

Thanks very much, Jane. I really appreciate that. Welcome, everyone. As always, it's always thrilling to speak to our investors and give you an update on the business. We obviously have an updated picture that all 3 of us will go through. I'll do the lion's share of the talking today. What you'll notice is a lot of these slides, you may have seen before from the previous investor presentation that we put out on the ASX. With some modifications here and there as we did release our quarterly results, so we've added some of that information into the deck. And certainly, 1 of the most important things to talk about will be the SPP and a little bit of an update on that process going forward. So with that, let's start going here, Barrie, and we'll go down to the first presentation slide. So this slide here, we've updated with quarterly information. It's just 1 of my favorite slides, right? In regard to what we have accomplished as an organization. Number one, just talking about who we are, right? We're an IVD medical diagnostic products company. But most importantly what we're really geared to is to point-of-care applications where we can deliver actionable information right there at the patient bedside. And really hopefully transform that practice of medicine for the doctor and the patient right there at the bedside. So we're thrilled, as everyone knows, we've received the 510(k) clearance with CLIA waiver from the FDA here in the U.S. This is something that I've been here for almost 4 years now in a couple of more months, and this is something that is really than something that we knew would be transformative for the company, and we're just thrilled that we finally have that and can start to implement our game plan going forward. In regard to that game plan, that CLIA waiver is what now allows us to go after 270,000 different locations or healthcare provider sites in order to access about 80 million patients a year that are diagnosed with acute respiratory infection. So in general, that's really an untapped $1 billion market for us that we're just thrilled to now be able to access. And getting ready for that, right, we signed a deal with PHASE Scientific. They are our exclusive distributor in the U.S., and they signed up for a 6-year commitment to us with a minimum volume that equates to a $317 million revenue to Lumos over that 6-year time frame. Now to speaking briefly about how did the business do and with the quarterly update, boy, we're feeling great, right? This is all based on really significant business that happened throughout the year or the first 3 quarters without CLIA waiver. Now we did get it at the very, very end, and we did get a great order from PHASE in relation to that. But we're having a fundamentally solid year as we are here with almost USD 11 million here in about 11% year-on-year growth so far. But probably the most exciting number is the fact that we did secure so far in the year, $3.9 million or almost $4 million in sales revenue for FebriDx. So that's just a great start. And we're looking forward to capitalize on CLIA waiver and continue to drive that number going forward. Overall, the services business continues to perform totally in line with what we expect with good, consistent margin for the business, and you would have seen throughout the quarter updates with Hologic and Aptatek and MicroPak in our quarterly as well. And then lastly, we continue to make sure that we're trying to do our level best to continue to bring money into the company. In addition to the terrific opportunities we've had to raise cash in capital into the company. Likewise, we try very hard to bring in non-dilutive funding into the company. And what I just represent there is that right, that's over $20 million in nondiluted funding that we've brought in over the last 3 years into the business, right? And very proud of that fact and things that we're trying to be very good stewards to the business and to our investors in that regard. Next slide, Barrie. So we get this slide. I'm kind of a little bit off center here. On the right-hand side to the left is the Board, including myself that have been together since I've been here. And then a few of my key people on the management team on the right-hand side. Really the takeaway here is that both from the Board and from leadership and management, we have a number of players on our team that not only have been very good at developing product and getting products registered and getting it on the market. We've also been very, very good about bringing products and launching those products successfully into global markets. So that's really a key point here is -- it's 1 thing to get a product to market. That basically gives us the license to hunt now, right, we're going to be held accountable to now we'll implement that and drive that revenue going forward. So we're really excited to begin to show and demonstrate our capabilities going forward in that regard. Go ahead, Barrie. Okay. For those new to the business, what are we trying to solve for here? I always like to think of things in terms of unmet medical need, right? So prior to FebriDx coming to market, the real question that people had when they had an acute respiratory infection, they go to the doctor and they say, well, what do I have, number one? And how can I best be treated, number two. And really, other than getting mostly, especially here in the U.S., a COVID and a flu test with flu A&B, called the combo test here. They get that test and then they take their other clinical symptoms. And the problem that presents itself to the clinician here is that whether your infection is caused by bacteria or whether it's caused by virus, you present with the same clinical symptoms. So it's very, very difficult on the physician to decide who should get antibiotics and who should not. And quite frankly, that is the rub here. What you see is that almost close to half the time, antibiotics should not be prescribed to patients because they have a viral infection, not a bacterial infection. And for us, what we love about FebriDx and what we think the market, both the clinicians as well as the consumer market from a standpoint of the customer mean a patient going to see their doctor, we can now solve this question. Is it cause? Is that a bacterial -- is that infection caused by bacteria or by virus. Next slide, Barrie. So this is the test, FebriDx, a simple finger-prick blood sample and in 10 minutes, you do the test, and it just gives you just wonderful performance, right? It can rule out a bacterial infection over 99% of the time. So that really helps the physician know. This is not a bacterial infection. Therefore, I should not give antibiotics. And it's a very, very simple test that's looking at what's called the host immune response, condition of the patient. We're measuring 2 biomarkers, one's called CRP, the other is called MXA and based on what this test shows up on its test line, it will tell that doc. What is this bacterial or in the U.S., non-bacterial answer. Go ahead, Barrie. Now what's also terrific about this for Lumos, for FebriDx and for our investors is the fact that, we do have just a wonderful patent estate, I'll call it, around FebriDx. As you can see here, 59 patents that we've applied for, we've now been granted 50 of those patents. And equally as important as the time still for -- before expiry of those patents. The earliest ones that are core to this begin to expire around 2038, and that's without any of the big extensions that we have that are pending. So we're feeling very, very good about being able to go to market, build this market and having time to actually be able to show the rewards of that work that we'll do over the next decade plus of time. Go ahead, Barrie. So a key item is just how does it work here in the U.S. from -- if you have an infection, you go to see the doctor or the urgent care. You present, you go to the check-in desk, you fill out your insurance information, they ask you what your symptoms and then they say, "Okay, we need to go triage". You go in a room to do your vitals and so forth, your temperature and all that. But if you present with acute respiratory infection like symptoms, they then will also give you a COVID flu test at that time in about 15, 20 minutes later after the triage. After the triage, you'll see the doctor. The doctor will have in hand that triage test of COVID flu and along with all your other vitals. And then that doctor will make that treatment decision based on that limited information. And as I said before, 40% of the time or more, they get that wrong about whether or not they should give you antibiotics. And then they will bill the insurance carrier to get covered for the visit by the patient as well as the COVID flu test. What we present as a solution to the doctor going forward, quite frankly, is something that just fits side-by-side with the COVID flu test. So now when you go into that triage room, everything still stays the same. But now in addition, you'll take a simple finger prick 10 minutes, you'll get the answer. And the doctor now will have 5 answers going into this. Do you have COVID? Do you have flu A? Do you have flu B? Is it caused by bacteria or some other virus? We don't know, but in general a virus. You have these 5 results plus your clinical symptoms, now they can make the most appropriate decision around antibiotic treatment, and then they'll do the billing, okay? I will point out just 1 thing that happens in the U.S. the physician does not get reimbursed or they don't bill nor do they get reimbursed for actually writing a script, okay? That's a pharmacy play, and it's something that happens elsewhere. So what they're just trying to do is let me make the right decision so that I do not have the patient reoccurring and coming back in a few days, and there's penalties in the payment system and so forth, if that happens. So they want to get this right and take care of the patient. Go ahead, Barrie. So as we've said before, we did launch this product over a year ago, but in the moderate complex. That's really to ERs and hospitals and so forth. The product isn't, I'd say the best product for that market. This is really geared for a simple ease of use like a COVID flu test for physician offices or urgent cares. So by getting the CLIA waiver, huge market expansion for us, huge opportunity, and we're really excited about going after this huge market of 270,000 different locations. Barrie? A key item to understand is how is that segmented, okay? Here on the left-hand side, you can see all the groups that are fit into this point-of-care CLIA waived environment. And what I just represent here is that there's 2 really critical areas. One is called the urgent care center. These are 24/7 medical offices that patients can go in with certain types of conditions and get certain types of tests and scripts and so forth or you go to your primary care physician, right, the GP office. These are the 2 key areas, okay? And then there are further put into how many locations are there. So 14,000 urgent care locations, but what's critical about that and what we're going after in that segment. About 300-plus ownership groups owns those 14,000 different urgent cares, okay? So that's 300. So that's an area that both PHASE and Lumos together are really driving, right? It's a pretty, I'd say, nice condensed group to go after at the C-suite to really drive this test uptake in, and we'll talk more about what we're doing there with WellStreet and other sites. And then the primary care groups, that's the 160,000 GP locations. That's a lot harder to hit, right, with just PHASE and/or Lumos. So that's where you use the huge U.S. distributor networks like Henry Schein, McKesson and others that will hit those primary care sites for us. So we're really, really excited about the opportunity to now take FebriDx into these environments. Go ahead, Barrie. So listen, we think that we -- on 1 of these guys go simple. And if you have a simple story and if it's understood, typically, it's going to work, right? So this is a very simple story about how you position this. Number one, to be successful, you have to have a clinical benefit. As we started out talking about, we're the only test that can do this. we can help the physician at the point of care easily with a very time-limited -- time to see that patient know is that acute respiratory infection being caused by a virus or by a bacteria, right? We're the only ones. It's an unmet medical need that we can address. Secondly, U.S. system is a pay-to-play healthcare system. So everyone who participates must make money, okay? So think of that as us as the manufacturer PHASE as the exclusive distributor to us, the sub distributors like McKesson and the doctor's offices, right? Everyone must participate in covering their costs and making some profit. So with our dedicated PLA code, right, which we secured well before our CLIA waiver, clearance from the U.S. FDA, we were able to secure that at $41.38. And given our COGS, we make money and all the other participants make money. We'll talk about that on the next slide. And then lastly, the final thing is this has to be very simple for a physician just to put it into their workflow. They have patient care continuum where they present, right, and then they triage, then they make the therapeutic decision and then they bill. And it needs to just fit into that tight little continuum very nicely, and this does it side by side with a COVID flu. Next slide. So this just gives you, I'm not going to spend too much time on it, and you can read this on your own, but suffice it to say, all the major players here are going to make profit on this to represent our interest. We'll make to start from day 1 about 60% gross margin on this product. Barrie and the ops team and so forth are working to plan that with volume growth and with our contracts with our suppliers, we'll be able to grow that to about 80% gross margin over the time frame of the PHASE agreement. So we're really excited about that. And then you can see here some good margin, healthy margin for the other players in this continuum. Next slide, Barrie. So a lot of people ask about the PHASE contract that we have and how it breaks down. This gives you a breakdown right, of what we've done with PHASE and you can see about the payments that they made to date. So here, you can see, so far, they've paid us $8.5 million to date, okay? And now we just have CLIA waiver. Now the real work begins, and quite frankly, the real revenue and real margin begins for all of us because now they're committed to another $308 million over the next 5-plus years here, okay, for years 2 through 6. So we're very, very excited about this. And this is 1 of those moments as a person who's been in this field for like 35 years. We're very, very eager now to go out there and demonstrate. Well, this is how we launch a product and driving in to use here in the U.S. market. Go ahead, Barrie. So we've talked about that continuum, right, from when the patient presents all the way to the billing. So understand that, that is a critical component here, right? You can have a great test addresses an unmet medical need. And it's pretty simple to use. But quite frankly, if the payers don't pay you for it or pay to a healthcare provider, it will not work. So right, we talked about those 3 boxes that are critical, that second box is the economics. And this is really critical for repeat customers and for the healthcare providers to be able to not only use the test initially to help, but then ongoing use of the test it requires them to get paid by their -- by the insurance companies in order to cover the cost of this test. So what you can see here is that, right, we are getting paid for this, Medicaid, Medicare, which accounts for 25% of payments, okay? We have secured that at the full amount of $41.38. So that's great news for all of us. Private insurance, which covers the remaining 75% of the patients out there, that is an active and ongoing process of getting them to ultimately write what would be called the formal payment policy to have it automatic. Right now, what we're seeing is, with working with WellStreet, and we monitor this with them, that 5 out of 8 of the national private insurers had been paying at the $41.38 or above, okay? So that is -- to be quite frank about it, that's just phenomenal, okay? A lot of companies, what they end up doing, they get their CLIA waiver, they get their FDA clearance, then they go try to get a CP -- they use a CPT code or try to get a PLA code, and then they get the amount that is going to be -- and that can take you like 3 years. We did all this prior, so it really sets this market up for us. And then we're monitoring this and a keen, effort is to work with 2 of our consultants, one is PRO-spectus, and the other is AcuityMD, and really tracking this in helping the clinicians get paid because ultimately, we can get our PLA code, we can get the CMS dollar value of $41.38, but ultimately, the physician must get paid by the insurers. Now we hire PRO-spectus to help them get it. And that is going to be a critical next step is just getting that momentum of the payments going from the payers to the healthcare providers. Go ahead, Barrie. So I talked about the -- I think what was that number, 14,000, Barrie, I think, of the Urgent Care's locations out there, and that's covered by about 300 ownership groups. Well, 1 of those groups, WellStreet, is made up of 163 Urgent Care locations, and we started a pilot program with them to basically kind of go back to that 1 little slide with those the triage room and the doctor and then the treatment decision. Just making sure this made sense and was simple and they could do it and WellStreet implemented that at 3 of their locations. And then as soon as we get ahead, received CLIA waiver, they said, "Okay, great." We can now put this into 43 additional sites and start rolling on this. Now what they also plan to do is right after that 43 are up and running, then they're going to bring on the rest of their 163 locations. And what's great about this is, right, they did 1.1 million ARIs, right, in 2024, okay? So that's going to be a great customer. Now they are a top 10 Urgent Care in the U.S., right, of those 300 different ownership groups. This is a top 10. So what we started to do now is we take the learnings from this, kind of turn us into a playbook for us with PHASE to now go after the other 300-plus of these ownership groups to get this implemented. And right now, as we've communicated before, we have this going, right, at pilots going similar to what we did at WellStreet at 8 other locations or 8 other groups across the U.S. currently. So a very, very exciting area. This is what we call in this business. You're going for the wells, right? These turning these on 1 at a time has a really large impact because all of these sites get activated, right? So that is a real critical step in our strategy going forward. Go ahead, Barrie. So this is FebriDx first from WellStreet. This is their turn that they used with us and everything. And what they're doing is something even a little bit different than what I was representing where we'll just add CLIA waiver -- I mean add FebriDx to a COVID flu test. They actually think it's in our best interest to get the right answer for the patient first, and they're going to do FebriDx first. And then based on that answer, they'll decide what other testing do they do, whether that's rapid strep, if it's a bacterial or should they do other tests like COVID flu and other tests. So this is just a terrific example of how they will go forward with FebriDx. Next slide, Barrie. So I'm going to be very, very brief here. I've already talked about this. A critical element aside from -- of the Urgent Care is just to go after a primary care. The GP offices. This is where we will use the huge distributors in the U.S. to go after that. Paul and team have been extraordinarily active over the last weeks, and implement -- it's almost been a month, I think, since we actually obtained a CLIA waiver. So they have gone to, I think, 3 different distributor annual meetings for training. They've been 2 significant conferences and showing how this test works and getting distributors up and running. So we're really looking forward to getting these distributors online, more than 2,000 of them across the U.S. to go after that primary care market. And then another item, which is really core to our use of proceeds is driving awareness, both to the physician and to the patient. And we're in the process of getting that project off the ground and running here over the next, let's call it, month. So very exciting from that standpoint. Next slide, Barrie. Okay. So the other large part of the use of proceeds is our scale-up operations. So that's a photo of our facility in Carlsbad, California. We will be significantly renovating that space to add the capacity needed to supply PHASE over the next 6 years what they need to sell to, to deliver the $308 million in revenue to us over the next 6 years. Next slide, Barrie. And Barrie, I'll turn it over to you for the financial summary.

All right. Thanks, Doug. I just wanted to go over some of the quarterly numbers in a bit more detail. Here, we've got the same charts we've presented previously. So we've got revenue on the left, revenue mix in the center and then net cash flow on the right there. So please, obviously, review this chart -- this chart, this slide in conjunction with the quarterly announcement yesterday, which has more detail in it. But just a few comments. And also just to remind everyone, our reporting currency is in U.S. dollars. So these are all in -- all these numbers are in U.S. dollars here. So revenue for the quarter was $4.8 million. You can see that in the chart there on the left, on the right-hand side, $4,822 thousand, which was 37% higher than the prior corresponding period, so Q3 FY '25. And you can see that in the chart there was $3.47 million on the far left, which brings our year-to-date revenue number to $10.9 million, which is, as Doug said, is up 11% year-on-year. Products revenue for Q3 was $2.4 million. So that's compared to $0.7 million in the prior corresponding period, with the majority of that product revenue being sales of FebriDx. So that's up over, I think, over 240-odd percent year-on-year versus the corresponding quarter. On the services side, revenue was $2.4 million for the quarter versus $2.8 million in the prior corresponding period across our 12 projects still. Strong contribution from the projects with Hologic. And the IP agreement with Hologic, but also the other projects we've announced recently with Aptatek and MicroPak. And MicroPak also recently just signing a supply agreement for us to manufacture their product for them, so the reader and the assay for MicroPak. One thing I would just point out, the IP revenue recognized in Q3 FY '26 was actually $0.8 million than the prior corresponding period. So excluding that item, our actual consulting revenue in Q3 actually grew year-on-year. It was just a reduction in the IP revenue that we recognized that caused the service revenue to drop there by $0.4 million. Just turning to the cash flow. You can see our net cash outflow for the quarter was $3.1 million. And just the definition of net cash flow on the bottom there is comprised of operating and investing cash flow plus lease payments. And if you actually -- so compare that to the prior corresponding period was $1.6 million. If you add up the 3 quarters for the year, you'll also get a cash outflow of around $3 million as well. Cash balance at the end of March was $1.1 million. And you would have seen in our half year financial accounts, we did draw down the line facility of $1 million just during the quarter. And just a couple of last comments on the cash flow. So as per our announcement on the 8th of April, we did receive placement proceeds, $20 million before costs. On the 14th of April, we did receive the $5 million prepayment from PHASE, and we have invoiced BARDA for the $0.5 million, their final milestone payment under the CLIA waiver contract. That $0.5 million will come in, in the next couple of weeks. So just some cash flow receipts since the end of the quarter. I think that's it for me, Doug, I'll pass it back to you.

So overall, I'm really pleased. I think what we're seeing is we're delivering as we have said we would deliver for the company and, hopefully, for our investors from a standpoint of hitting our revenue growth numbers and seeing just the terrific increase in the FebriDx revenue number, especially from in this last quarter. So feeling great about that. And likewise, really, really positive in regard to now we can get rolling in implementing this PHASE deal and a significant uplift in revenue that we expect to get from them over the next 6 years as a business. So really, really just pleased with the results that we had in the last quarter, getting the CLIA waiver and now starting to implement our plan and the success that we've had in our first pilot with WellStreet, and then looking forward to translating that into just continued, what I believe will be a very, very successful launch for FebriDx for years to come. So with that, I think we can turn it over to the capital slides. Barrie, if you're going to go through those...

Yes, I'll go through those, Doug. So given we're still in the SPP window, which closes this Friday, the 24th, we thought we'd just go over a couple of the capital raise slides to remind folks, mainly around the SPP not going over the placement. So as many of you know, it opened last week. I think the key point here on this slide, a couple of key points. So new shares issued under the SPP offer issued on the identical terms of the placement. So the price per share is $0.225 -- so $0.225. We can see here the discount to the last close and the VWAP. Just moving down, I'll go through the use of funds on the next slide. Just moving down a little bit under the SPP, given that terms are identical, SPP offer participants will also be invited to apply for 1 option for every 2 new shares subscribed for. The exercise price on those options is $0.34, and they expire on the December 31, 2027. So those options are identical to the option offeror that the institutional investors received. The options are not quoted on the ASX. And obviously, new shares issued under the SPP ranked equally with all other fully paid ordinary shares. I won't go through this in too much detail. I mean the use of funds was outlined previously. Just a couple of comments. If you look on the right there, and primarily in the last command, the U.S. dollar common -- use of funds is really in 2 areas. Manufacturing expansion for FebriDx. You can see the $2.5 million and the $4 million there. And then sales and marketing activities for FebriDx. Marketing at 7.8% in the medical implementation team as well, which is really a team to go around and assist the clinics with the implementation of the product in their clinics. And just to remind everyone, again, quickly on the dates. As I said, it opened on the 27th and it closes this Friday. SPP closing date, Friday, the 24th of April. We'll do the allotment straight after that, on the 1st of May, and then they can commence trading on the Monday, the 4th of May. I think I've got -- just 1 final slide here. So I thought it would just be useful to put a little bit of information about the current share register for Lumos. So as at the record date, there was 3,744 shareholders on the register. And as I said, the SPP terms are identical to that offer to institutional investors. And majority of shareholders, so you can see there in the chart, 3,202 shareholders have a holding of less than about 133,000 shares. So the majority of shareholders have the potential to maintain their pro rata ownership post the capital raise by participating in the SPP. So I just thought it'd be worthwhile providing a little bit of color on the share register to just sort of highlight the number of shareholders that currently hold less than 133,000 shares. You can see the numbers for various other ranges as well. Sorry, Sam, go ahead.

I think I was going to jump in as well before we jump into Q&A about this as well because these slides are in response to questions we've received before. And about the actual share register, composition, et cetera, and some of the decisions around capital raising. I think Jane has got a long list of questions alongside George, and we're trying to respond to them as fast as we can. We've got a relatively limited team. Most of the questions can be asked -- answered by Jane and George, but sometimes it involves the rest of the team to actually provide a response. So please be patient, doing our best to do that. When you look at this particular slide, one of the other questions that we had, which was to do with Barrie's last statement about pro rata. As a Board, we consider that with the SPP because the $30,000 cap is obviously legislated. We can't go above that. But we did look at that as part of the SPP and what percentage of the share register could do pro rata if an individual wanted to do that. It's actually 92%, so slightly different to this lens here of our register could actually put in up to $30,000 and maintain that position. We thought that was actually a really important point. The Board is always going to look to try and make sure that whether it's institutional, sophisticated or retail that they are the same terms. I guess in the SPP, there is a limit in terms of cap, but the Board did suggest that there was potential for oversubscriptions. I wanted to emphasize also because we've had to get into Q&A that Q&A is really important because it does influence us. We put this information in because we received questions around the SPP and the ability to get to the pro rata position and maintain position, et cetera. So this information is in response to some questions we've received from investors. Similarly, the PHASE Scientific announcement regarding the $5 million, that was large -- it was constructed a lot based on investor feedback as well. And we had questions about revenue versus cash and wanting to make sure it's very, very clear as to that new $5 million coming in, whether that was to do with old or new orders to be received. So I'm just encouraging everyone, if you got questions, please, by all means, get to us. If they're constructed professionally, we'll try and answer them very, very quickly as best we can. And we -- Doug and I had a call with a retail investor, I'm pretty sure you won't mind me referencing this. And here, it's really great questions that we went through with them one-on-one. He also mentioned some online information that he received, which he believed potentially came from the company, and it didn't. And it was really important for him to mention that to us because we could actually give him our position. And so for that reason, what I'm saying to you as investors, please feel free if you hear something or you want something clarified, get in touch with us, we will respond as quickly as we can. We've got a little bit of a backlog now. So please be patient, but we will get to it. One more thing, Jane, I want to mention in terms of investor engagement to the end of year financial results. Obviously, coming up later this year, the intention is for Doug to be in Australia. And to give you all an opportunity for -- if it works out, one face-to-face investor update. Details will follow at some later date once we lock those dates. Jane?

Great. Thank you, Sam.

I'll just stop sharing, Jane. I think rest of the presentation is just the risks, which everyone has seen, I think.

Okay. Yes. If you'd like to look at those, please review the presentation that's up on the ASX. So with that, thank you, we'll open up the floor to Q&A.

We have received a lot of questions for a limited time. We'll get through as many as we can. So first few that came through via e-mail in the lead-up to the session. So in relation to FebriDx, is there an update on progress for Medicare rebates in Australia, Doug?

Yes. Thanks so much for the question. And I think as you guys know, we've talked about this before. We are actively pursuing that process. Our initial attempt, we were unable to secure that, but we did get some great information to be able to proceed with another route through collecting additional local data and using the study, I think it's from -- Barrie help me out here, Wollongong, I think, is how you pronounce it, and I apologize...

University of Wollongong.

Yes, sorry for that. So we'll be conducting a study there with a significant size, comparative study. We test more than just the FebriDx test, but that would go a long way to helping us in being able to justify and securing reimbursement there in Australia. So it is something that we're pursuing. But as most of you probably know, it does take time to be able to secure that.

Thanks, Doug. Okay. Following on from that. Also, is it thought that Australia and other jurisdictions that the company is entering will follow the U.S. with its National Action Plan for combating antibiotic-resistant bacteria mandate that was recently enacted?

Yes. So number one, I would say, listen, this is something that other countries have already done as well. So U.S. wasn't the first to do this. In fact, as I think Australia had something very, very similar back in 2023, if I remember when that was started there. We think that this is very positive, right, for healthcare on the whole and certainly can be for diagnostics, and we expect other countries will continue to drive diagnostics as well as antibiotic stewardship going forward. So yes, we think this is a good thing, and hopefully, we can leverage that at a high level.

Thanks, Doug. What impact is expected from the recent decision in relation to the U.S. National Action Plan for combating antibiotic resistant bacteria?

Yes. This is the same thing really just -- the U.S. version. So it's -- again, it's a positive thing. And we'll look to see how we leverage this over time. But as with most government programs and so forth, they take time to enact and move forward in, but we think it's a good thing for FebriDx and for Lumos possibly.

Yes, great. Okay. Have you commenced discussions with other large clinical groups about FebriDx? Or is this PHASE's responsibility?

Yes, that's a great question. And we get a few and we always get, hey, what is PHASE doing? What are they spending money on marketing-wise versus us and so forth? So I think -- let me give you this in a nutshell. One is both organizations are trying to do what is in the best interest for implementing in launching the product, meaning we, at times, do some things by ourselves like we're going after all the reimbursement stuff ourselves and working with our consultants, PRO-spectus and AcuityMD in driving getting all that in there. To go after these large sites like WellStreet, that's actually a tag team affair, right? We are both driving those together. Bob Gergen in his team and Paul Kase in my team -- in his team, these guys know each other very well. They know this market very well. They have great relationships. And together, we're stronger, right? So we aren't doing these things together. Now what I would say is, so they have -- they're going to be accountable for like managing all the dealers and distributors. So they have to buy, if you will, invest in the infrastructure and the people and everything to really drive that. They will also invest in all the conference marketing stuff and the ad board stuff, this classic marketing spend that does get expensive. And you got to go everywhere with it, and they'll be accountable for that and representing the product into the customers. We are going to, though, spend our marketing dollars in regard to that reimbursement app, but also creating product awareness, right, for physicians and for the consumer market as well. So again, it's a tag team affair. We think it's the best way to go after this, and drive this going forward.

Thanks, Doug. I think you've covered a couple of questions at the 1 time in that response. So I appreciate that...

Yes, I'm trying to do that.

Yes. Well done. There is a specific 1 here, though. With the funds earmarked for marketing, do you plan to give regular updates on the use and benefit to Lumos of the marketing spend?

Yes. Let me say, right, number one, just I know there was a question or 2. We don't provide guidance around the revenue numbers and our volume numbers at this stage, right? But we really think it's critical that we understand and have a dashboard of key leading indicators of, hey, how are we being successful and how are we driving that? What I just represent is that is a place where we want to get to. We're not ready for that today. So I can't commit to exactly what that is and what the exact time frame. But that's a great question. And one, the Board has right asked us as management for us to deliver to the Board. And then obviously, we can think about once we do that, how do we "appropriately" share that market at the appropriate time and makes sense. So it is something that we will work towards.

Can I add a little bit of detail to that, Doug, as well -- because, obviously from the Board side, you from the management side, both of us have worked actually as competitors in our long distance past, Doug. And I think we both appreciate that in a distributor network, sometimes you lose fidelity of data because there's a couple of steps in the chain. And so the reason why Doug is saying that it takes some time to develop those leading indicators is because it's naturally difficult to get all the right data that's actually a really good useful leading indicator that you can continue to get day after day, month after month. So it's not atypical for that to be the case, which is the reason why I was referencing our past live because we had exactly the same situation.

Thank you, both. Okay. And there are a few questions in here around forecast revenue, et cetera. I think you've tried to answer those here, Doug, at the moment. It's -- it would be -- we're not quite ready for that. But thanks for the questions. So back to the PHASE agreement. So of the initial orders from PHASE as per the agreement upon signing and CLIA waiver submission, how much is still outstanding from that $2.5 million, Barrie?

Yes. So from the $2.5 million that was prepaid, all of that product has been shipped and recognized as revenue. So that's fully consumed, okay. From the $5 million that we just received last week, none of that product is shipped, yes. So it's still to be manufactured by us. And when we ship it, we'll recognize it as revenue. So hopefully, that answers the question clearly.

Yes. That's great. Conscious we're slightly over time but let's just get through a few more of these, if we can, and then we'll let everyone go on their days. So Doug, could you please provide a progress update on the pediatric study? When do you anticipate you will submit to FDA?

Yes. So as I think when we do the last -- was it in our quarterly, Barrie, from last quarter...

Yes...

You gave the update on the $720 million (sic) [ $720,000 ] I think it was called milestone 6...

$720,000 -- million would be good thing...

Sorry. A better number, Barrie. Yes, like that. So anyway, milestone 6, so we received that. We're in process of moving forward toward milestone 7, and that would be the next announcement associated with this once that's achieved, and we're able to bill and invoice against that and get payment, then we would announce that in -- right on the ASX as normal. But it continues. It's not a short trial. We've -- I think we've consistently tried to say that that's something that's going to definitely go into the end of the calendar year, okay? So we'll give appropriate updates as we can. But as with any clinical trial, it's just, okay, you're accruing patients. That's the way it is.

Excellent. Okay. Question here, do we need to wait until late July for the next sales and revenue update? That has been our cadence around quarterly reporting.

I guess 2 points from me on this one. Yes, the next quarterly will obviously be the Q4, which will be released at the end -- towards the end of July. I think as Sam and Doug have already said, if there's anything material, and we need to meet our continuous disclosure obligations, we'll announce those if they're material. But otherwise, it will be in the quarterly update.

One thing to just add, I think around that is especially for FebriDx because right, that's the lightning rod of everything for us, and we love that. In the U.S., we have -- this is a seasonal -- this is going to be a seasonal play, right? Flu season for us is, let's say, at widest October to February and March. That's kind of the very, very widest time point for flu season. So as you can imagine, those off-season, your revenue numbers are much lower. In-season, your revenue numbers are much higher. I just say that to set expectations for people that there is seasonality to this. And we are now going to be coming up on our summer time, which is the lowest time for respiratory infection here in the U.S. So just -- I give you that, it's just some education on the market dynamic here.

Couple of interesting segue questions from there. So the first 1 is ever considered expansion into veterinary healthcare as more antibiotics are prescribed for animals than for humans.

Whoever gave that question, if they have expertise in that, I'd love to talk to them, right? Listen, it sounds like an opportunity, right? I'd always look at opportunities. And that's a great market, especially in the U.S., I assume it's the same for Australian, right? I have 2 labs and you'll do anything for them. So listen, the vet market is a great market.

Well, we are doing -- in the service business, we are doing a project for a vet healthcare company. We're not allowed to provide the name or the type of product, but it is certainly -- it was certainly 1 of our clients who is very interested in that space.

Can I give a slightly different response, Jane. I mean, work in diagnostics as well. 1 of veterinary yet lower regulatory requirements and the clinical trial costs and all that sort of stuff. So when Doug talks to the cost of clinical trials, the seasonal nature of our business, all of those sort of things, it's really great to be sitting here with the first product in market with all of those barriers to entry for competition because we do have competitors. We are aware of companies that are working on things that are striving to get to the point that we're at. And so focus is a really important thing that we, as the Board continue to talk about with management and our services is naturally quite broad in terms of who we work with and if people pay us, then obviously, it builds capability and all those sort of things. But I also want to stress the CLIA waiver is a transformational opportunity. There's a lot of work to be done there. So for that question that came in from that shareholder whilst it's an interesting thing that Doug might want to follow up on. I do think it's really important that we make sure that rubber meets the road.

Thanks, Sam. Good focus. We do have a question on pipeline. I'll ask that quickly in a minute, but let's just go back to FebriDx for a second. How much of the U.S. groundwork translates to progressing Canada, U.K. and EU markets?

Yes. Good question. Just so that you guys noticed I did run point-of-care diagnostics for what was Bayer and Siemens at 1 time and lived over in the U.K. for many years. So I think I know these markets pretty well. The good news is they do translate, but there is a time lag. And a lot of that has to do with the whole reimbursement system and nationalized healthcare and getting payments and payment for the product and so forth. So yes, I definitely see this as something that will translate, but there will be a time lag before it really starts to take off there.

Okay. And we might just make this one our last question. Again, we've probably got another 10 in the queue. If we didn't get to few, apologies. But as Sam mentioned earlier, please feel free to follow up with IR and we'll get back to you as quickly as we can. So final question, noting your comment around focus, Sam, any quick comments on other potential products in the pipeline, Doug?

So we continue to work with our women's health portfolio, but you guys understand, right? That is a feasibility stage. And you'll note that we have, I'd say, small R&D dollars dedicated to that currently. And that's what we need to have from a focus standpoint, right? We'll work on the women's health portfolio at a feasibility stage. And when it's appropriate, appropriate stage, we'll announce to the market, hey, how did we do? I mean, what comes out of that or not going forward. But yes, we continue to progress that. It's just -- right now, the focus is FebriDx. So you get most of the comments are going to be around FebriDx right now.

And I think the -- add to it. I know the comment about focus, Jane, but we're looking for synergies in the organization where -- so the second and third and fourth products don't cost the same as the first one, right? So whether that be strategic relationships, whether that be cost synergies and commercialization, all those things, and the Board along with management proposed the women's health opportunities to us, and we could see some of those synergies. And so that's the reason why we're working on it.

Okay. Well, thank you. Appreciate everybody's time. We've gone over a little bit, and there are still a lot of people on the line. So thank you for that. Doug, I might just hand back to you for any closing comments.

Yes. I would just say thank you very much for taking the time today to talk to us. We do sincerely appreciate that. We greatly appreciate the support of our investors, and we'd love to have new investors, but also the SPP is live and will continue here, and we'd love to get people and further invest in take advantage of, I think, a great opportunity right now to invest in the company. Well, we are just at the very, very beginning of what I think is going to be a transformative company in the medical diagnostics space here. So again, thank you, everyone. We greatly appreciate it, and we look forward to giving you more updates as we go.

Perfect. Well, with that, I'll add my thanks to everyone, including Sam, Doug and Barrie for your time today. And with that, invite everyone to disconnect. Thank you for your time.

Thank you.

Thanks, everyone.