Lumos Diagnostics Holdings Limited (LDX) Earnings Call Transcript & Summary
July 29, 2026
Earnings Call Speaker Segments
George Kopsiaftis
attendeeAll right. Good morning, everyone, and welcome to the Lumos Diagnostics Fourth Quarter '26 Investor Briefing. My name is George Kopsiaftis, and I'll be your moderator for this morning. Joining us from Lumos today, we have Doug Ward, Managing Director and CEO; Barrie Lambert, Chief Financial Officer; Paul Kase, the Chief Commercial Officer; and Sam Lanyon, the Chair of Lumos Diagnostics. As many of you would be aware, Doug is currently in Australia. He's meeting with a number of investors as part of a road show. And just as a reminder, Doug and Sam are presenting at an investor information session today in Melbourne, at 3:30 PM and on Monday in Sydney at 3:15 PM. Anyone that would still like to attend but hasn't RSVP'd, you can just refer to the ASX website for the details. So today, the team will be presenting the presentation that was lodged on Monday. The presentation should go for about 30 minutes, and then we'll open it up to Q&A. The plan is to be finished by 11:00, but we can run a little bit over, if needed. And at that stage, I'd like to hand it over to Doug.
Douglas Ward
executiveExcellent. Thank you very much, George. Terrific to be here. Sorry, I just squeezed Sam out of my view here, but that's okay. Thank you, everyone, for joining us today. Very excited to give this presentation and an update on our Q4 performance as well as a little bit of insight into the commercial momentum that is occurring right now with FebriDx in the U.S. So with that, we'll get into it. Listen, our objective here, though, is to try to give you guys a little bit more time than we have in the past relative to Q&A. So we will not be going through every slide that was lodged on the ASX. So we'll go through probably about half of the slides in pretty quick order, quite frankly. Hopefully, they're the most important and meaningful to everyone, but certainly feel free to ask questions in regard to any of the topics, whether we speak to those slides or not, we would appreciate that. So with that, we'll get started. Barrie, if you don't mind. So number one, especially for those who are new to Lumos. One, thank you for being here today, but I always think it's really important to understand who we are and what our vision is, right? We're a point-of-care diagnostic company and most importantly, we're really trying to improve the practice of medicine. And I think we're on the cusp of being able to actually implement that with the launch of FebriDx here in the U.S. in the CLIA-waived environment. So without further ado, we'll get started with a little bit of review on Q4 and then a little bit of the update on how we're doing from a sales progression. Barrie, next slide, please. So I think this is always a really important slide to level set everyone. Number one, I feel as though the company has never been in a better situation than it is right now. I am over the moon about where we are, number one, in terms of achieving the FebriDx CLIA waiver in the U.S. and giving us access to this very, very significant market. For those who have listened to Barrie, Paul and I speak in the past, only a couple of times in your careers do you actually get to launch medical devices that actually transform how medicine is actually performed. And we think this is one of those, and we're so pleased to be able to do that right now into this huge untapped market potential that we have. And the way that we will do that again is, is through our distributor network to sell the product to the end user. So we have a distribution -- an exclusive distribution deal with PHASE Scientific where they have signed up for a minimum of roughly $317 million, almost AUD 500 million over 6 years, right, to really build and drive this market going forward. For those who did not catch our commercial update webinar, I think that was probably in the June time frame where we did have PHASE Scientific's Head of Commercial, Bob Gergen, as well as Paul and our Director of Sales, on that call. A lot of good information in there, and I encourage you to have a listen to that. So we are now in process of rolling this out. And what you will hear from us going forward are a number of key leading indicators, and you're going to see a couple of slides in here with those numbers. You can see them on this slide so that you guys understand what kind of momentum we're having. And I can say right now, it's going better than I expected. But quite frankly, just very, very positive with FebriDx as well as, quite frankly, our services business as well. We can't forget, right? That's been the lion's share of the sales of this company for years, and it continues to be a very important business within FebriDx and it continues to track very well for us as a business. Next slide, please. So we'll go to the next slide, please, Barrie. I just want to briefly comment here that what I feel great about typically from the financial standpoint is, one, no surprises. I feel as though we did exactly what we had thought that we would do. And without providing guidance, I think people could track that we continue to perform well throughout the entire year with some year-on-year sales growth, but an exceptional year-on-year sales growth for the flagship product, FebriDx. So I feel very, very good about that. And then the only other thing that I would raise is it is so important to this business to be successful that we have a cash balance, right? And since I've been here over the last 4-plus years, we've never had this level of cash in the bank to be able to really drive this opportunity. So we're really thrilled about our cash position at this time. So with that, I'll let Barrie make a couple of comments here, and then we'll get back to the rest of the update.
Barrie Lambert
executiveAll right. Thanks, Doug. Yes, in the interest of time, just a couple of comments from me. I won't go through every bullet point. So we have the Q4 results here in the charts and also the full year FY '26 revenue and cash flow numbers as well. Just to remind everyone, they are in U.S. dollars, which is the company's reporting currency. And also, you should definitely read the quarterly report, the Q4 activities report in the 4C, which has a lot more detail there on this slide, obviously. So please make sure you take a read of that if you haven't had a chance to do so, so far. So as Doug said, very happy with the revenue for FY '26, came in at $13.2 million, 6% up year-on-year. And just a couple of quick comments on the quarterly results of Q4 FY '26 versus Q4 FY '25, and also the full year number for the services business as well. I just do really want to highlight that we were impacted quite a bit by the reduction in revenue we recognized on the IP agreement. Q4 was actually $0.8 million in Q4 this year, less than Q4 last year. And over the full year FY '26, the IP revenue we recognized was actually $3.2 million less than the prior year. So that did have an impact. So putting that aside a very strong performance with the project business in the service area, was up 24%. As Doug said, FebriDx revenue was $3.9 million for the year, up 875% year-on-year. So very strong numbers in every other part of the business. So very happy with that. Just a couple of last comments from me on the cash flow. You can see the 4 quarters there on the right. If you add up the 4 quarters, you get to a cash outflow of $2.8 million for FY '26. And one really important point is we -- as we mentioned during the capital raise back in March, we do plan to invest in expanding our facilities in California to meet the demand expected sales of FebriDx. So we did make a payment in Q4 to the lead contractor for the build-out of those labs, dry room, assembly areas. And you can see we did a CapEx of $2.3 million in Q4, which impacted the cash flow, obviously. Then last comment from me, as Doug said, $15.4 million on a cash balance at the end of June. No debt. The facility we had with Ryder and Tenmile was closed, and any security they have over the company is being released. So strong position to move forward with. So I think I'll leave it at that, Doug, and happy to take questions at the end of the presentation.
Douglas Ward
executiveYes. Terrific. Thank you very much for that, Barrie. Great looking numbers from my point of view. So thank you. Next slide. So we're going to just go through a few updates here. One of the things that we received feedback was, hey, people would like to have more information about how things are tracking relative to launch after CLIA waiver. So we have tried to raise the bar relative to the quantum, but you can appreciate the quantum has to be also about the quality. So we've done a great job, I think, since the start of May, we've had 20 what we call EDMs, right, which are e-mails that go out to those people that register to receive our e-mails. Those consist of not only the ASX announcements, but what we call other PR that we do inform that aren't worthy of disclosure, if you will, and don't meet necessary requirements for the disclosure, but we still wanted to provide people with as much information as possible. So here you can see, I think we've done a really good job in trying to keep everyone as aware as possible of what's going on since the launch, again, just 3 months ago of FebriDx with CLIA waiver from the FDA. Next slide. Now we did a version of this slide, I think, through May in the June commercial webinar and really, there were a couple of things since that time that we really wanted to bring out. One was the conference for nurse practitioners that we had up in June. That really went over well, a lot of great leads that came out of that program. But even more importantly, in the month of June, we've actually had over 47 on-site trainings in our Tier 1 and Tier 2 sites. And as you know, right, that was Tier 1 and Tier 2, that's the top 100. That's our focus. And if we -- quite frankly, if we do really well in bringing those online, we're going to put ourselves in a great position to be successful here through flu season come November through March, April. So next slide, please, Barrie. Okay. As Barrie had just mentioned, a critical part of where we need to go is to be able to make sure that we can produce the volume that we need to meet the demand that PHASE and Paul and team are going to drive. It's a highly regulated product, right, within FDA clearance. So therefore, there is a bit of a lead time relative to one doing the work. And right now, we're renovating our facility in Carlsbad and transforming that into a higher capacity manufacturing facility for us. And we're hoping that this is something that will be near completion and online toward the end of the calendar year. We'll give updates, obviously, as we progress. But a key item there really has also then to put it through the validation process so that we can meet the demands of regulatory bodies of product that's manufactured there. So this is a significant step forward for us in terms of ensuring that we meet that demand from the PHASE agreement over the next 6 years. Next slide. So as we've said, we continue to provide the market here with our leading indicators. What you would have remembered is last time we said it was greater than 100 sites. Now we're very pleased to say we have more than 170 sites. Those sites are called live sites. And you'll see [indiscernible] there's a definition of our funnel, our sales process, our commercial process. Our live sites are what we call standard adoption, standardized adoption, that's what people are now using it in a standardized format. So we now have greater than 170. That equates to basically 700 to 1 million ARIs in total visits. And probably, I think I've stressed this a lot. The next upper right-hand box is really 1 of the most critical things to enabling our success. So what you'll say is, okay, that's the same number that you gave last time, and that is the great news. Quite frankly, this is way ahead of schedule to have payers, right, the private insurance companies paying more than 90% of the time on any claims for a brand-new test. It's never been utilized and you're billing the insurance companies. I wouldn't have thought it would be close to this number. But understand that from the original time that we communicated this to now, numbers are actually a little bit better than the greater than 90%, if you will. But we're going to stay right there because I expect that to fluctuate around that number. But we feel really great about where that is and that the average payment is greater than that $41.38 number. So if we stay here, quite frankly, this will be a huge windfall for us because this is way, way ahead of schedule for everything that I've experienced in bringing the test to market. And likewise, we've now -- we're now live in 24 states in the U.S. So we look forward to continuing to expand that, and we look forward to giving these numbers as we give our leading indicator updates on an ongoing basis. Next slide, Barrie. Just a quick comment. Listen, pediatric study is still ongoing. What I can say is we probably won't have -- a lot of people ask for updates around this other than the milestone payments, when we achieve those, we give those updates. I don't really expect to give any substantial update around the pediatric study and to probably closer to the, let's call it, October to December time frame. And then we get more information about, okay, what kind of readout do we have with the study, where are we with BARDA and what we're doing with that study in the billings and so forth. So more to come on this, but still progressing toward the end of the calendar year. Next slide. Probably a new thing you would have seen this out on the EDMs as well. We have announced that we are now -- for the first time ever, Lumos has contracted with a marketing agency to help us drive awareness of the product, right, to treating physicians, nurses, practitioners and so forth. We chose CG Life. They're a very well-known firm here in the U.S. You can see some of those companies listed at the bottom there of who they work with. They're very, very familiar with the introduction of new products, especially into the point-of-care environment and driving awareness with treating physicians and so forth. So we're thrilled to get started with them. Next slide. Okay. Just a few more quick slides here. Listen, one of the key things that I think is really important because obviously, we get a lot of questions, people, where -- you have CLIA waiver, where is the revenue numbers? We really want to see those. Listen, this is -- this graph, right, this bar graph is a distribution of how CDC tracks flu. And this is how the respiratory season works in the main in the U.S., okay? So you see that it kind of begins with November. What happens there in the U.S.? That's Thanksgiving. Everybody gets together, people come home from school, they infect each other, and then flu season really takes off through the holidays and everything and kind of starts to peter out in the April time frame. So this is what you're going to expect. I think, quite frankly, timing is everything. We've been very fortunate that we received CLIA waiver in March because what it does is it allows us to get these sites up and running and used to using the product and validated in their workflow to allow us so that when flu season starts, we actually have an installed base of active customers. And I said right now we have greater than 170 sites live. So we're using this time ever since we started here in April, if you will, and we'll continue that right into flu season, but we're just driving as many sites to go live as possible to be ready for the seasonal increase in respiratory illness in November, December time frame. Next slide. So you kind of see this is just our vision of kind of, well, how will this track, right? Right now we're really -- it's all about targeting those sites and getting those up and running and getting a lot of awareness through the new marketing agency initiated and then really driving that hard in Phase 2, which will be the October to December standpoint to really get these physicians, and urgent care is very familiar with FebriDx out in the market. And then it's all about okay. From there, we just continue and continue to roll and drive demand. Next. So this is a new slide that we've introduced. This is our funnel. People want to know, but talk to us a little bit about the sales process. It's a classic IVD sales approach. As you know, what we're doing is, there's -- we're really -- we, together with PHASE, are targeting the top 100 urgent cares, right? That's 5,722 sites. In those, and we're hitting all of them. And it's about engaging them and qualifying them as an opportunity, okay? Once you do that, then it's about getting them to purchase product. And they then validate that. They validate first of all, clinical performance of the test. That's a very -- actually I got to say we're 100%. Those people that have brought it in and looked at it, love it from -- it does what it says it will do and that it can fit into their workflow, right? But the biggest item, and if you think about the 3 pillars that we normally talked about, you have to have clinical performance, you have to have workflow efficiency, but the last is you have to have the economics. Everybody needs to make profit in this setting. So then they must do their economic validation. That is the long pole here, okay? That can take up to 4 months to complete that because they're doing the work, sending it off to the payers, getting the response back from the payers, sometimes it's paid. Sometimes it's not, they have to appeal that and so forth. But that is a give-and-take process. On average, it's about 90 days, could be shorter, could be longer, right? What we're really pleased with and what you would have seen last week was we announced 3 additional big accounts that are pretty far along in this clinical economic validations. So they're a top 10. So much like Wall Street, right, we get the question, do you have another Wall Street example? Is that a one-off or whatever? No, we're using this to track and do all of the top 100. Okay. Now we're very, very much engaged with another top 100 in this economic validation part. We also have another top 25 and another top 30. And you can see here what that means from an ARI standpoint. That -- once they complete that economic validation, we kind of consider that, okay, that's a go-live decision and they now implement the test. Take Wall Street. Wall Street did their validation at 1 site. They then quickly went to 44 sites. So they did their network rollout to the 44. Those 44 are now in what's called implementation Phase 2 or standardized adoption. Those 44 are 1 of the 170 live sites across the network. So we're -- like I've said a few times now, this is going really, really well, and I'm really pleased with the job that our team has done that PHASE is doing as well as their sub-distributors. Next slide, Barrie. Okay. If you don't mind, I'm going to have Paul to speak to one of the most recent and new opportunities that have -- that we're announcing to the market here. Go ahead, Paul.
Paul Kase
executiveThanks, Doug. Appreciate it. Yes, this is an exciting slide. So first, important to note. This is in addition, this slide and this health system we're going to refer to right now is in addition to the commercial traction update that Doug just referred to and that we lodged last week. And so exciting news. So, hot off the press, if you will. And so this is a health system that's located down in the southeast of the U.S. They've committed to move forward with FebriDx. Their urgent care sites greater than 25. And so to Doug's point before, just another account in the top 100 that is moving forward, extremely excited to announce it. If you look at that bottom bullet point on the left side, talking about successful validation and then supporting expansion. It's really important to note from a health system standpoint, and this account falls under that is that you start on the urgent care side, you prove that success, right? And to Doug's point, go through the validation, the economics, et cetera. You improve that success and then you -- the expectation is to then bleed into, in this case, over 300 primary care sites that are part of this health system. So in a way, a bit of a gift that keeps giving, right? You just start on the urgent care side and the expectation then is to migrate on to the primary care side. And that's not just with this health system, but the others that we announced last week as well. So very exciting news. We'll keep the good news coming because there's a lot of it. And we'll make sure our communication continues to be consistent and transparent. So I'll turn it back over to you, Doug.
Douglas Ward
executiveTerrific. Thank you very much, Paul. Next slide, Barrie. So with that, this is our last slide, everyone. So listen, right now, the business -- things are going really well. We'll continue to obviously have FebriDx as a core priority, both in terms of driving that and getting new customers, but also implementing our game plan with PHASE and our other partners, AcuityMD, PRO-spectus, CG Life in driving that awareness as much as possible, which I have to say, this is -- this momentum that we're seeing, this is prior to the whole awareness campaign coming. This is due to the work that Paul and the team since, I'd say, about February through to now of attending all the congresses that they attended and getting this awareness in front of those people that attend and then those leads come in, and it's people calling us right now based on those interactions at those congresses, and that's what you're seeing right now. I'm really excited about once we launch with CG Life and so forth and driving that awareness about where that can take us to the next level. We'll continue, as I said, talk about the pediatric study as that's warranted. And as always, the services business, it's going well. It's a core part of the business. And as we achieve some of those new milestones and payments, we'll continue to inform the market of that. So with that, George, that completes all of our slides that we would go in. Now again, there's more comprehensive number of slides that were in the announcement, feel free to have a look at those, and we're happy now to take any questions that people may have. And again, we have myself, Barrie, Paul, and we also have Sam here as well to help address any questions you may have.
George Kopsiaftis
attendeeAll right. Thanks, Doug, and thanks Barrie and Paul also for your updates today. As a reminder, if you would like to ask a question, there's a Q&A box in the ribbon below, please click on that, and just type your question in there, and I'll ask it on your behalf. First question, is the supply chain in good shape for anticipated sales?
Douglas Ward
executiveYes. I would say that we're in great shape from a supply chain standpoint in all regards. It gets a lot of attention, and we've been focused on it for the last few years, I'd say. Quite frankly, it's -- Barrie is in the U.S. right now. I'm over in Australia. Barrie is working with the team, especially around things like what you're asking. Barrie, any updates from the team out there in regard to supply chain updates and so forth?
Barrie Lambert
executiveEverything is traveling well, Doug. I think the team here is really positive. We're not seeing any disruptions or any issues with the supply chain. Tariffs have thankfully reduced from China now sitting at 10%. So any product from China is much lower than it was before. So the team here, the manufacturing team, the ops team, the purchasing team are very happy with where we're at on the supply chain. So no issues from this side.
George Kopsiaftis
attendeeGreat. Thanks, Barrie, and thanks Doug. Next question. At the standardized adoption side of ARI presentations, what's the percentage usage of FebriDx because I'd say, presumably, it wouldn't be 100% given that under 12 and over 64 are not approved for usage or reimbursement under the FDA approvals.
Douglas Ward
executiveYes. Great question. Okay. In twofold. One I'm going to just tell you what the reality is today, and then we'll talk more about that coming forward perhaps as an indicator going forward. But so you can imagine we have kind of two extremes, I would say, relative to new sites coming on live. One, you have someone like a Wall Street who has committed and stated, hey, we are going to run a FebriDx on almost all their patients. Now will all, to your point, not all, but geez, if we get 80%, 85% of all their ARIs, that's brilliant. We would love that. That's kind of one extreme. The other extreme are those accounts that could come on and go, "Hey, you know what, I'm going to run it with a flu or I'll run the flu first, then I'll run your test." And then as you know, in what we've communicated before, like, that flu testing is about 20% of the ARI population that accounts have. So that end points here are probably something around 20% at one end to, let's call it, 80%, 85% at the other end. And really, probably, I think, a core part of our success is how do we drive as many of these sites up as far as we can towards the 80%, 85% analysis. That's our plan. We think we have great logic and some tools to help us get the accounts there, quite frankly. But to your -- I think this is a key point that -- this is going to be a measurement of success. Now we're not going to know these answers and stuff to probably until we get through that flu season itself. So probably at a best case, maybe during the flu season, we might be able to -- maybe at Wall Street or something like that, we might be able to say what's the percentage? What's that ratio happening. Across the whole market, or across the sites that are live, my instinct is it will be hard for us to do it until we kind of are toward the end of the flu season. Then we'd have enough data because you got to remember, this data that comes in. Normally, we're also about a month behind the data that comes into our CRM and all that. So great question, one that we agree that is going to be an important one that the market will want to know and we'll want to let the market know that. But also, it's going to have to be one that, I think it's going to be data driven in the end. So thanks for that question. It's a good one.
Paul Kase
executiveIf I may, too, because it's pretty comprehensive. We even have pediatric accounts, large pediatric clinics that are very interested in FebriDx. And so they will be using it for a population, for example, of their kids coming in from 12 to 16. So it's impossible necessarily at that point to grab all their ARIs, right? But then there's that section of the -- for their 12, 13, 14, 15, 16-year-olds that we will be capturing with FebriDx. And so as Doug said, that it is different for many of these accounts, and we'll continue to grab that data as often and as quickly as we can.
George Kopsiaftis
attendeeNext question. Lumos has recently announced its new marketing partner, CG Life. Could you share what the marketing strategy would be going forward? And how this will complement what your sales force has been doing to win new customers?
Douglas Ward
executivePaul, do you want to take this one?
Paul Kase
executiveSure. So again, we have a digital product marketing manager, we've added to the team as well as a Senior Director of Corporate Marketing. They are actively involved in the launch with CG Life. We've had multiple kickoff meetings over the last week. We believe we'll have media into market at the latest of September, so initial campaigns. They will absolutely be in line and complete lockstep with our current strategies that we've laid out here as far as our urgent care top 100 and the physicians and the nurse practitioners that are part of those offices. So it's going to be a very focused campaign and it's going to be exactly where we are currently staying focused from a sales strategy. So both marketing and sales and CG Life are, as I said, in complete lockstep with the strategy and with the campaigns. We also have analytics being provided for each of these campaigns to be able to judge obviously, how we're doing and who we're reaching. But to Doug's point before, we're already -- there's a push and a pull, right? And we've already seen some pull with unsolicited requests, and we think CG Life will help provide a catalyst to even more pull, but we're going to stay exactly into this top 100 from the standpoint of urgent care. Hopefully, that answers the question.
George Kopsiaftis
attendeeA question on manufacturing and volume. This is what's your expected total volume that's expected to be generated out of the newly expanded manufacturing facility? And then I've got a follow-up question still around the facility.
Barrie Lambert
executiveDo you want me to take that one?
Douglas Ward
executiveYes. I saw Barrie -- go back. So Barrie, go ahead.
Barrie Lambert
executiveWell, yes, I mean we can give precise volumes because they obviously -- there's a flexibility, I guess, in the facility we have. We're building a facility and adding a certain number of lines and certain number of shifts, and you can always add more shifts and more lines, which we have the space for. We have the facilities today to deal with this upcoming U.S. flu season. And as Doug said, there's a long lead time to set these facilities up and validate them. So we're really planning for the following flu season is in this new facility is in the years that come after that. So the new facility is obviously capable of meeting the MOQs and the PHASE agreement. And more than that with additional lines, adding some automation equipment and so forth. So we're very comfortable that the new facility will more than meet the demand over the next 6 years or more. So hopefully that answers the question. George, I don't want to -- I mean, I don't know whether I want to give exact numbers, Doug, of capacity. But suffice to say, we feel comfortable with where we stand in meeting the demand over the coming years.
Douglas Ward
executiveIt's certainly well into the millions without a problem, but we're not going to probably say exactly what that limitation is. And I'd go so far to say to Barrie's point, we're building capacity, but we'll have a lot more capability for more capacity if we choose, right, if we need that, whether that's more shifts, more automation or even more lines to be brought in. So the good news is, we'll be able to deal with the PHASE agreement, but we also have the capacity to go well beyond that, and that flexibilities go into that, if you will, into that footprint.
George Kopsiaftis
attendeeAll right. Yes. The next question was more about some little detail around it, I'm not sure you really want to answer it. But part of the question was when do you think you'll be moving to a second shift?
Douglas Ward
executiveI think, look, I've met many times with the VP of Ops over here, Anthony. We can deal with this current flu season with probably with 1 extended shift, so a long shift. If we need to add a second shift, we can do in this flu season, but I don't think it's needed at the moment based on expected demand. So we're going to a sort of a 5 by extended shift, so 5x10, for example, but we can certainly go to a 7 by 10-hour shift, if need be. And then we could add a second line if need be. So we've got some flexibility around meeting demand.
Samuel Lanyon
executiveProbably worth saying to just from a macro perspective, the Southern California area in terms of being able to access technical resources quickly, it's very good right now. In the past, it's been -- it has taken some time, but right now, it's actually quite good just because of the industry situation. So being able to put on more people to use the facilities and equipment is actually relatively straightforward, which is always easy for a Board Member to say to the operating people.
Barrie Lambert
executiveThere's some -- obviously, the raw materials we've got to have on hand. And so we're doing -- we're being very smart, I think, in the amount of raw materials -- we're making sure we have on hand to meet the demand and then some over and above that, but not without going crazy. So we're taking that into account as well. Not just the labor, but the raw materials too.
George Kopsiaftis
attendeeAll right. Great. Next question. When is the year one of the PHASE Scientific multiyear agreement is supposed to start?
Douglas Ward
executiveIt has already started. Thanks. If they did -- right that, then have to with CLIA waiver.
Barrie Lambert
executiveYes, it's a good question because -- sorry, like the contract was signed in July 2025, as everyone knows, the CLIA waiver was only received in March '26. So does year 1 starting July '25? Or did it start in April '26? It's a question.
Douglas Ward
executiveWell, the commitments, the MOQs initiated on CLIA waiver. So yes, the contract started in July, but the actual MOQs in that first year commitment, if that's what we're kind of referencing which was the $5 million minimum and they had to pay that upfront that occurred with March 27.
George Kopsiaftis
attendeeGreat. Next question. So on average, how many sites does an urgent care group sitting in the top 100 typically cover? And should we also expect that each of these sites to see roughly 3,000 ARI patients per year similar to Wall Street.
Douglas Ward
executiveYes. So number one, I mean, you can do the math, right? You can sit there and go, there's 5,722 divided by 100, okay, that's your average number of sites across the board, so, right? So 50-plus per ownership group, if you will. But certainly, right, in the top 100 is critical that we can go after that 40% with just 25% of the focus on the 25% of those ownership groups in go after 40% of the opportunity. Now in regard to the number that you stated, George, in this, actually, there is some -- in that deck, there's numbers. I would say that most urgent cares in the top 100 are going to be above the number that you just stated as an average. Now there could be some sites that just have lower volumes and so forth, right? But in the main, you would sit there and say, of those 5,722 in the top 100 sites, they do somewhere in ARIs between 4,000 and like 5,500 on average. Some, like, Wall Street quite frankly do more, okay? Some of their subs do more. And -- there will be some of those sites that do a lot less. So I hope that, that helps you out, but it's a good question. In the debt material, there are some data in there around averages and so forth that hopefully can help people try to -- when they're trying to triangulate in that numbers and so forth.
Samuel Lanyon
executiveI think, can I just chime in too. You mentioned this during the CLIA waiver webinar that we had. One of the things that between board and management, we've been talking a lot about is leading and lagging indicators. That's another one that you go from the average and industry-based metrics to actually Lumos-based metrics. And the commitment from the company is to, is to start to share that those once they become statistically significant. And we know that is a very relevant one, just like the previous question before.
George Kopsiaftis
attendeeAll right. Great. A question for you, Paul. It says new urgent care group customer win that you referred to earlier, is that in addition to the other 3 urgent care groups announced last week that is still in validation phase? So in total, are there 4 urgent care groups that are now currently in validation phase.
Paul Kase
executiveOkay. So last week, we announced one health system and 3 urgent care groups. This is in addition to that, and it's another health system. That's in the top 100 for their urgent cares with over 25. Does that -- hopefully, that answers the question. It is a bit more new...
Douglas Ward
executiveIt's 4, Paul.
Paul Kase
executiveCorrect.
George Kopsiaftis
attendeeNext question. When do you expect sites to start stocking up for the flu season? Will you announce record PHASE orders going forward?
Douglas Ward
executiveSo 2 things. One is, things have changed in the market relative to -- when you couldn't get a COVID test, right, and I was with Hologic, we were selling COVID tests left and right. People would take these huge stocking orders to ensure that they had product, right, because the demand was way outperforming the supply. That's no longer the case. And a lot of these distributors now, they're not going to take like a 4-month supply and put it into a warehouse and then ship out of it and so forth. So quite frankly, we expect that there'll be maybe 30 days a month ahead to make sure they have product on the shelf relative to those shipments that they get the next month. But we're not going to have these mega million unit stocking orders just a stock. That kind of is no longer a typical item.
Samuel Lanyon
executiveThere's a part 2...
George Kopsiaftis
attendeeOkay. Great. Yes. I guess that...
Samuel Lanyon
executiveSo the announcements piece, I think, as well, obviously, as those call-offs are happening and the products are being shipped and then we'll inform the market about that.
Douglas Ward
executivePHASE.
Samuel Lanyon
executivePHASE orders. Yes.
George Kopsiaftis
attendeeYes. So a question that sort of follows on from that. What inventory level of your FebriDx product is PHASE and yourself holding at this very stage?
Douglas Ward
executiveYes, we don't give our inventory levels on the product and so forth. But like we've communicated many times and we meet with PHASE and call specifically and the Ops team go through the build plan and everything else. We're totally on top of, okay, this is PHASE's forecast. This is our build plan to make sure that we meet it. And what we would let the market know is, hey, we feel as though we're in a great place without any issues to meet the demand that we expect and that PHASE expects this season.
George Kopsiaftis
attendeeAll right. Great. I don't think you're going to want to answer this one. It's a guidance question, but can you please share revenue projections over the next 6 to 12 months?
Douglas Ward
executiveNone at this time. Thank you, though, for the question. I love it. Honestly, we get it. It's a brand-new product and trying -- and I'm sure a lot of you guys have been around this. Trying to forecast a brand-new product. We could so under call it or over call it easily without a little bit of just experience here. So we don't want to do that to ourselves or to the market. So no, we're not going to give that information out this year.
George Kopsiaftis
attendeeOkay. Great. Next question. Of the $41 reimbursement, how much does Lumos expect to receive?
Samuel Lanyon
executiveThat's more of a gross margin question.
Douglas Ward
executiveYes. And I think what we would say is, and we've always communicated that when we sell the product to PHASE, we achieved 60% gross margin on the product.
George Kopsiaftis
attendeeAll right. Great. This one just comes back to the question around when does the PHASE distribution agreement start? Because Doug in a previous webinar, you stated that year 1 starts from the start of the calendar year following the grant of CLIA waiver. So that means from an MOQ perspective, we're now not in year 1.
Douglas Ward
executiveYes. Listen, I'm happy to review exactly what I was saying was, I believe, and if I misspoke, apologies for that. It is a calendar year, not a calendar. It is a year, right? 365 days, if you will, after we get CLIA waiver. So you get that on March 27, that starts that first year. It ends on March 26, 2027. And then year 2 starts March 27, 2027, right? That's -- and it is a year long, that's 1 year, 2 year and subsequent, right? So that's -- so if I say calendar year, I apologize, if that was perceived as some January to February or January to December, it's a year.
George Kopsiaftis
attendeeOkay. Great. Can you see FebriDx becoming available for the at-home use, i.e., will customers be able to purchase it from a chemist?
Douglas Ward
executiveGreat question. And it's something that -- listen, I would just theoretically, you could maybe see that, right? Things have evolved so much since COVID, right? I think -- during COVID, you would have never thought this test would ever even think about an OTC approach into the market, right? Now with the pandemic and everything in the movement of COVID flu tests and into the pharmacy for OTC, perhaps, but I have to tell you, right now, we are 100% only focused on trying to optimize right now into the urgent care and primary care CLIA waived environment in the U.S. And I'd say maybe that product eventually could get there, but I can sit here and go, okay, I'm not telling you it can or it can't because we just -- we got to focus on what we're doing right now.
Samuel Lanyon
executiveMaybe worth giving an Aussie perspective as well. If you think about pre-pandemic, and you think about our plans, OTC was never on the table. It just didn't factor into any of our long-term plans. After post-pandemic, it's definitely become interesting. And I think there's always a question about whether we would -- whether we try and sell FebriDx in a big way outside of the United States. I think when you start to talk about OTC in rest of world applications, it's actually quite a bit more interesting in post-pandemic period. Now you can go down to your Aussie chemist and buy yourself a COVID flu test off the rack. And you wouldn't typically see that used in -- actually at the GP or the urgent care. So yes, it's a really interesting question. It's something that's evolved over time, and it's some pretty serious interest to us.
George Kopsiaftis
attendeeGreat. Thanks. Look, I'm aware of the time. I know that you guys have to get to another roadshow meeting shortly. So this will be the last question. For those, there are a few questions left, we'll answer -- we'll try and answer them directly with you. So this final question. What's the updated plan on geographic rollout to counter the U.S. seasonality?
Douglas Ward
executiveIt's a good question. The only comment I'd make is I'm not necessarily -- I don't think we need to worry about it being an offset if we're really successful with the U.S. flu season, but that carries us quite frankly. So -- but now having said that, again, I've said this before, I think I ran point of care for Bayer Siemens way back when in Europe, based in Europe and everything else, that the point-of-care system given the way the health systems are paid for, don't lend themselves easily to very quick adoption of point-of-care technology ex U.S. That's just the way it is. Now having said that, it does eventually get going. But normally, there's a good -- I would say, probably looking at like a 2-, 3-year lag time, and then it kind of starts out like 1 or 2 countries at a time, and then slowly builds from there. So -- that we continue to want to build our ex U.S. installed base, if you will. And we do see nice year-on-year growth there. But I think it's going to take years before you really start to see significant sales numbers coming out of ex U.S. territories.
Samuel Lanyon
executiveI think it ties into question too, George. Like the -- that point I made about the OTC, some regions, it actually -- that would be potentially the primary way of accessing that market. It's just we've got to do the work on where we should be putting our investments to get the best shareholder returns.
George Kopsiaftis
attendeeYes, understood. All right. Well, that's the end of the questions, given the time available. Doug, I might just hand it back to you for any closing remarks.
Douglas Ward
executiveYes. Number one, I'd just say, hey, thank you very much for your continued support of the company. We're very excited about where we're progressing and how we're progressing. We'll continue to provide updates as much as possible to try to give you some very good perspective so that you can share quite frankly, in our positivity of how things are going. So you have our commitment to continue to do that, and thank you all for being here today. And thanks a lot for all the great questions. Glad we had a little bit more time this time to address as many as we did, and we'll follow up with those that we didn't get to offline.
George Kopsiaftis
attendeeAll right. Thank you. Thanks, Doug. Thanks Sam, Barrie and Paul for your update today. Just a quick reminder to everyone again. We have got this investor information session in Melbourne this afternoon at 3:30 PM. So everyone's most welcome. The details are all lodged on the ASX. And again, if you're Sydney-based, we're doing it on Monday at 3:15 PM. So please come along, all are welcome. To everyone today participated, thank you very much, and we look forward to keeping you updated. That concludes the webinar for today. Thank you all.
Douglas Ward
executiveThank you.
Read the full transcript via the API
You're viewing the first half of this call. Get the complete Lumos Diagnostics Holdings Limited transcript — plus 252,000+ transcripts from 12,000+ companies, speaker segments, AI summaries and full-text search — through the EarningsCalls.dev API.
Get the API View API docs →This call discussed
For developers and AI pipelines
Programmatic access to Lumos Diagnostics Holdings Limited earnings transcripts and 252,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.