Lumos Diagnostics Holdings Limited ($LDX)
Earnings Call Transcript · March 30, 2026
Highlights from the call
In the earnings call for Lumos Diagnostics Holdings Limited (LDX:AU) on March 30, 2026, management announced the granting of a CLIA waiver for their product, FebriDx, which is expected to significantly enhance market access and revenue potential. The company reported a revenue of USD 12 million for the last fiscal year, reflecting a 12% year-on-year growth, primarily driven by licensing and services. Management expressed optimism about future growth, particularly through a $317 million sales agreement with PHASE Scientific, and indicated that the upcoming sales figures would be reported in the next quarterly results, marking a pivotal moment for the company’s commercial trajectory.
Main topics
- CLIA Waiver Impact: The granting of the CLIA waiver allows Lumos to access approximately 80 million patient visits annually at the point of care. CEO Doug Ward stated, 'Now we can go to 270,000 sites in the U.S.' This is expected to significantly enhance the adoption of FebriDx.
- Revenue Growth Strategy: Management highlighted a transformational sales agreement with PHASE Scientific, promising $317 million in sales over the next six years. This deal is expected to drive substantial revenue growth as they commercialize FebriDx.
- Manufacturing Scale-Up: The company plans to use proceeds from a recent capital raise to scale up manufacturing capabilities, ensuring they can meet increased demand. Doug Ward mentioned, 'We have enough capacity for 2-plus years,' indicating confidence in production capabilities.
- Market Penetration Plans: Lumos is targeting urgent care and primary care markets, with a focus on training and awareness to facilitate adoption. Paul Kase noted, 'We are seeing positive trends with those that are already using the product,' indicating early success in market penetration.
- Reimbursement Strategy: Management reported progress in securing reimbursement for FebriDx, with a PLA code set at $41.38. They noted that '5 out of 8 national private insurance are already currently paying for FebriDx,' which is critical for adoption.
Key metrics mentioned
- Revenue: $12M (vs $10.7M est, +12% YoY)
- Sales Agreement Value: $317M (over 6 years with PHASE Scientific)
- PLA Code Reimbursement: $41.38 (set for FebriDx)
- Market Access: 80M (patient visits annually post-CLIA waiver)
- Manufacturing Capacity: 2+ years (current production capability)
- Insurance Coverage: 5 out of 8 (national private insurers covering FebriDx)
Lumos Diagnostics is positioned for significant growth following the CLIA waiver for FebriDx, with a robust sales agreement and strategic plans for market penetration. The upcoming sales figures and the effectiveness of their reimbursement strategy will be critical indicators of success. Investors should monitor the execution of their marketing and manufacturing plans as key catalysts for future performance.
Earnings Call Speaker Segments
George Kopsiaftis
ExecutivesGood morning, everyone, and welcome to the Lumos Diagnostics investor briefing to discuss the recent granting of CLIA for FebriDx and the capital raise. My name is George Kopsiaftis, and I'll be your moderator for today. This webinar is being recorded today and will be available on Lumos' website. With us this morning, we have Lumos Diagnostics' CEO, Doug Ward; we have Paul Kase, Chief Commercial Officer; and Tracy Weimar, the Company Secretary. Good morning to you all.
Douglas Ward
ExecutivesGood morning, George.
Paul Kase
ExecutivesMorning, George.
George Kopsiaftis
ExecutivesGood morning. The format for today is for Doug and Paul to walk you through the presentation that was released to the ASX on Friday. This presentation should take around 30 minutes. This will be followed by a question-and-answer session, and we plan to wrap up in 45 minutes. [Operator Instructions] And with that, I'd now like to hand it over to Doug and Paul to get us started.
Douglas Ward
ExecutivesAll right. Thank you very much, George. I really appreciate it, and welcome, everyone, to this investor presentation. Boy, I'd tell you, I'm so thrilled to speak to you today, such a momentous time for Lumos Diagnostics and really stepping into the next, if you will, plateau for the company with the announcement of the CLIA waiver and the capitalization of the company. So we're going to go through this deck, which is an update on the business and what you can expect going forward relative to commercialization as well as use of funds and then also talk a little bit about the upcoming SPP and provide you some overviews there. So as I said, I'm just thrilled to be talking to you today, feeling very, very positive and happy about what's transpired here last week. So for those of you who are new to the company, and overall, we, Lumos Diagnostics, right, we're an IVD diagnostic company. We develop, manufacture and commercialize diagnostic products into the market. What's unique is that we really try to drive for what are called point-of-care applications. So those applications where the use of a test can inform a doctor right there with the patient to help with the best therapeutic and appropriate decision-making to help that patient. So that's what we try to do. Ultimately, I think we're about ready to get into the business of changing the practice of medicine with the launch of FebriDx here in CLIA waiver format in the U.S. So from a historical perspective, okay, we are a revenue-generating business. Last year, about USD 12 million in revenue. That was 12% year-on-year growth. Now most of that revenue, though, 90% of it, really was coming from the licensing and the work that we did in our services business, right, which is a nice profitable business, it does have nice margins associated but real transformational growth and ultimately getting the cash flow positivity is really going to come through our product offering. And that product offering is FebriDx, right? FebriDx is the first and only test to be used at the point of care with a CLIA waiver that can differentiate bacterial from nonbacterial respiratory infections. So very, very excited to be able to announce here. We do now have CLIA waiver. And with that, the reality of the PHASE agreement is now here, right? So we signed back in July of last year, a transformational deal with PHASE Scientific, and they signed up for $317 million in sales to Lumos over the next 6 years. So Paul is going to talk more about that a little bit later, which, by the way, this is the first time that I think that we've really featured Paul in one of these updates, really pleased to have him here with us today. He's our Chief Commercial Officer. And he's the guy that's going to make this dream a reality here with driving our revenue line as a business. So lastly, the only point I want to make is CLIA waiver by having this now gives us access to roughly 80 million patient visits a year at the point of care, saying we're going to -- Paul is going to talk about that market, what we're going to do to go after that and why we believe we're going to be really successful. Next slide, George. So for those also new to the business, this is a look at the Board. That's -- I kind of bifurcate that line. So everyone to the left there is on the Board. And on the right, is a couple of -- a few of the key leaders on the leadership team meeting. What I really want to focus on here and say, we have a number of people who come from very significant experiences launching new products into the U.S. and into the point-of-care environment and a number of us have worked for several of these or one of these companies over our careers. So I feel really excited that now that we have a product that actually is ready to be commercialized, we actually have the horses here that can -- that have done it, and we'll be able to do it for us here at Lumos. Next slide. Okay. So listen, we like to start out with what's the problem statement that's the easiest thing, right? Because to be successful, you really have to address some kind of medical need. So today, what happens, you get respiratory infection and whether it's caused by a virus or it's caused by a bacterial, it's actually almost identical symptoms. So when you go in and present to the physician and you have a respiratory infection, it's very challenging to easily differentiate that and consistently do it. So while the patient is there to figure out, hey, what's wrong with me and how should I -- what can I do to overcome this illness and the doc wants to know, hey, I want to know with some more certainty, what is causing this? That's a challenge that up until last week, you couldn't address at the point of care. Now it can be. So with FebriDx, right, we are now with our 10-minute test able to help the doctor with high certainty distinguish, is it being caused by bacteria, is it being caused by nonbacterial infective agents. And the reason this is so important is multiple, but the key is that once you test someone, say, for COVID and flu, which is standard of care here in the U.S. That's still a minority of the time that you're going to say, "Oh, yes, it's either flu A, flu B or COVID, majority of the time, the doc is still stuck in his quandary. Okay? Is it bacterial-driven or is it a viral-driven? And again, when they kind of make their best determination, they're wrong, 40% of the time, if not more. So that's a big dilemma. That's causing some significant adverse drug reaction. It causes also side effects, especially intestinal issues with antibiotics and so forth. And then lastly, you're getting more and more resistance to the antibiotics themselves, and that is really a bad problem for the globe, right? Because there are not new agents coming to market. And we need to make sure that only patients that appropriately deserve to get antibiotics, get the antibiotics. Next slide, George. So this is how it works. I'm not going to take too much time on this, but there are 2 biomarkers, MxA and CRP. And those 2 biomarkers used together are what make this a terrific test, an extraordinarily accurate test, right? So in 10 minutes, with a simple prick of the finger and a little bit of blood, you can rule out a bacterial infection more than 99% of the time. So nobody else can do this, and it just addresses this terrific unmet need that is going to take, I think, the market by storm. Next slide. So I talked about CRP and MxA, and I think it's really important for people to understand that, we have just a wonderful IP estate around this We have 59 patents, 50 of those have been granted. And it's really involved this core MxA/CRP method of use claims to differentiate bacterial from nonbacterial or viral. And the great news is that those are active until at least 2038. So it gives us some time here to get this product to market start to really drive the marketing plan going forward and then get it out and build this business over quite a few years here without the problem of other companies coming in with identical type of products and really driving down the price and undercutting. So it's great to have this IP position to differentiate us. Next slide. So a key thing to understand when we go after the U.S. market is this is the natural clinical pathway for how a patient is diagnosed and ultimately treated in the U.S. when you present with acute respiratory infection. So you go in, you check in to say your GP or a primary care office, or you go to an urgent care center, the first thing they're going to do is ask you a bunch of questions, okay, you're presenting with flu-like symptoms, respiratory infection. They'll bring you into a triage room, they'll do your vital signs. And here, it's standard of care to do a COVID/flu test today. And again, they'll to do that, and then the doctor will come in 15, 20 minutes later, they'll have that result. And then if you have COVID or flu, right, they'll treat you accordingly, right? But if you don't, now it's a little bit of a toss-up for him between viral versus bacterial and then you leave and go and then the doc bills the insurance carriers or whether that's government or private pay and they get paid for this. And this is a key, key part -- next slide, George. This is a key part of understanding how we will move forward in making this so impactful by just adding FebriDx, it's simple addition to the standard of care. So now instead of just doing a COVID/flu with a swab, you're just going to add a finger prick in 10 minutes. It will fit in that window. They'll get a FebriDx result. And now that physician or practicer, will be able to say, is it flu A, flu B, COVID, is it bacterial, or some other, right, nonbacterial agent causing this. So now they'll have a full understanding to be able to appropriate make the decision process. So this is what we are going to start doing and driving this into the point of care in the U.S. Next slide, George. So why is that CLIA waiver so important? It's this, right? We can now go to 270,000 sites in the U.S. and we -- with this, that will allow us to reach the 80 million patient interactions going forward. Next, So -- I'm sorry, Paul, was this the one that you're supposed to start on or you get a couple more to go here?
Paul Kase
ExecutivesI believe I'm after this one.
Douglas Ward
ExecutivesOkay. Right after this one. So I'll just say that the 270,000 we really, right, segment that market down. So we're looking at -- this is -- on the left is the pie chart says, okay, where do these 80 million visits go? And there are 2 areas that are just very, very specific subsegments that we are going -- that it's a straightforward approach for us to first prioritize and target. So the urgent cares, and there's 14,000 urgent cares in U.S.. There are about 30 -- 300 buying groups or ownership groups that own those 14,000 locations. So what you appreciate there is that, that 300-plus ownership groups, that's something that Paul and his counterpart at PHASE, Bob Gergen, are really going to drive. They're going after those 400 decisions. Paul is going to talk about a great test case and use case that we have going forward. And then the 160,000 primary care sites that is traditionally something that's accessed through the very, very large distributor networks here in the U.S., and Paul is going to talk a little bit more about what we're doing in that regard as well. Next slide. It's really here about -- there's 3 things that ultimately have to do to be successful in bringing a product to market in the U.S. Now honestly, if you miss one of these, you're not going to be successful. So those 3 things are clinical benefit. We've talked about it. We're the only one that can provide this detail to the doctor at the point of care and help them better diagnose their patients. You have to have economic benefits. We have our own proprietary CPT code that's called a PLA code for $41.38. With that -- and with reimbursement, we are able to ensure that all players within the care continuum, whether that's us as a manufacturer or PHASE as a distributor or the doctor is able to make margin, right? Because if you don't make margin, you're not going to last very long in this market. And then lastly, and I talked about this, the docs need this just to fit right into their standard operating procedure. They have a critical clinical pathway and they don't want to disrupt that and change that. But if you could just add this, and we're not displacing anything, right? We're not coming in and saying, "Hey, we have a better mousetrap, right?" We're sitting here going, nobody else can do this. You just add this side by side with COVID/flu, if you wish, and guess what? Both those tests are going to help you. So from that standpoint, check that box, we do these 3 things in spades. And I think at the end of the day, that's what's going to determine if we're successful. Go ahead. Next. The last -- I think probably the last slide I have here, Paul, is just -- this just so that you guys have a glimpse into understanding the value chain here around the role of the 4 players in this -- in our market. us, we're the manufacturers, right? That's Lumos. At launch, we're making 60% margin on this test. We're going to drive that up to 80% over the life of the PHASE agreement, so terrific for all of us in that regard. PHASE and other distributors are going to make 30%, 35% throughout this time. And the docs themselves should make more than 35% if they're getting reimbursed around that 41%. It could get reimbursed higher than that. But around 41%, they're going to make a 35% margin. And then lastly, just again so that you're aware, payers play a key role in this. They are the ones who pay this. And it's really important that you have that as a part of your strategy. And I think Paul's done a great job in actually getting a lot of this set up prior to the launch to put us in this wonderful position to hit the ground running going forward. So with that, Paul, I'll turn it over to you, and you can go from there.
Paul Kase
ExecutivesI appreciate that, Doug. Thank you...
Douglas Ward
ExecutivesOh, I apologize, Paul. One last thing. Sorry, guys. One of the key items, when Paul is going to be so successful on the revenue line, he needs the operations to totally deliver on the volume that he ends up having the POs come in for. And one of the use of proceeds, one of the most significant use of proceeds is the [ scallop plan ] around manufacturing. So what you see here is our facility in Carlsbad, California, what you're seeing in green and purple here are the areas that we'll be expanding into as we drive our plan going forward here over the next couple of years, we plan on initiating the work on this over the next quarter or so will be the initiation of it, and we'll continue to drive that while Paul is driving up the volumes. Right now, our current facility, we're able to deliver for the next, say, 2-plus years of the volume. And by having this in place over the next, say, 12 to 24 months, having it fully validated and in place. this is going to allow us to hit the volume going forward as we grow our business. So I think, Paul, with that...
Paul Kase
ExecutivesThat's good, Thank you. Doug, I appreciate it. And again, time is valuable. So I appreciate everyone who has either on the webinar live or took the time now to watch the recording, I appreciate that. So the PHASE deal, I think everyone has at least familiar with parts of it, and Doug did touch base on this. I'd like to make an analogy when I think about PHASE and I think about, say, the last 9 months of working with PHASE and Bob Gergen, again, who's leading their commercial, it's analogous to painting a room in your house. And so for those of us who are who are painting the room in your house, there's drop cloth, there's blue tape that you got to put up around the moldings, you've got all these extra supplies, you have to move the furniture in the middle of the room and cover with plastic. So 95%, in my opinion, 95% of painting is prep. The painting itself is actually still work, but a little more fun, right? So point is, I've had -- I've been on -- I've been quite joyous okay, since last week because we are officially painting, right? It happens to come with committed MOQs of $317 million. It also happens to come with a $5 million prepaid purchase commitment. That's great. But we are finally able to execute, and it's an extremely exciting time. But I'll tell you a little bit about the prep work with PHASE, and that is what went into all of that. And it's not as though everyone was just waiting for CLIA waiver grant. There's a ton of work has been accomplished. First, I'll talk about the distributors. PHASE has contracted with all the top distributors in our market, in this -- our urgent care and primary care market space that we're zooming in on. And that includes Henry Schein, hundreds of representatives. McKesson, I believe, just under 1,000 representatives in the field nationally, includes NDC, National Distribution and Contracting. It's a group, a very large group at a national Tennessee that actually works with all these regional distributors that have banded together to contract and buy product. And I believe they have close to 200 members. If you add all of those up, and those contracts are done. In other words, the pricing is loaded, the product that's being stocked. And we're now looking at over 2,000-plus field sales distributor reps who have access to the product in the U.S. as we speak. As you can imagine, it's quite busy right now. So that's -- first of all, on the distribution side of things. Next, Phase has executing an agreement with a contract sales organization. If you could hang with me and just go back, if you could, please, the next -- I'm still on the PHASE slide, George. PHASE is actually contracted with a company called MTMC. They have 120 sales reps in the country. Those 120 [ scouting ] throughout the U.S. will be supporting Lumos and PHASE in the field, selling FebriDx. So it's an extension of the sales arm. Not to be confused, they'll be working with those distributors, I was just talking about. So an exciting time with their launch, they officially have had the trainings, and we're in the midst, as we speak, of launching them into the field. So very exciting around that, too. We can go to the next slide now. So as Doug had mentioned, 1 of your major segments of your 3-pronged go-to-market approach is reimbursement in the U.S. There is a care that follows cash mentality a bit, right? You have to have a positive economic benefit to the physician offices. And a PLA code again 0442U. It is reimbursed at $41.38 on the clinical lab fee schedule. We're very pleased with that. But I'm even more -- I'm almost ecstatic of the momentum and what we've achieved already, even prior to, obviously, the CLIA waiver grant, which we just got last week. So Medicare and Medicaid come up with -- let's say, government, if you will, is 25% of your claims, right? And private is say, 75% of the insurance claims. So with Medicare, as many of you are familiar, we have all of the 7 MACs that are recognizing FabrDEX on the clinical fee schedule. And with Medicaid, which that is, by the way, Medicare is federal, Medicaid is state. So all 50 states in this case, state law supersedes federal law, so each state with Medicaid operates independently. We've made some great inroads already establishing in 9 states, Medicaid policy to $41.38 price. We're in progress with 3 others, and we have access to 5 others. So we're making great headway on the Medicaid side. But the best feedback I can give you so far when it comes to reimbursement, is we are seeing positive trends with those that are already using the product in multiple regions in multiple care settings, WellStreet Urgent Care, which I'll get to in a second, 5 out of 8 national private insurance are already currently paying for FebriDx. Let me just explain why that's so great. When you work through a novel test into the U.S. you have to demonstrate medical necessity, right? It's a dossier that you fill out and then you submit to the private payers, right, the Uniteds of the world, the Cignas, et cetera, right? So to already get reimbursement at the start without the actual coverage policy, right? You are basically that those payers are already recognizing medical necessity. It's extremely good news. And so I couldn't be any more pleased. Honestly, I feel like we're a year ahead of where I thought we'd be. Payment levels vary and there's still work to do. And I'll get into prospectus on a future slide on how they're helping us and acuity is helping as well. But we are engaged in coverage determination conversations. And the CLIA waiver now helps us to really crush the utilization and help expand our coverage. And we actually expect denials of the claim. So much like an insurance claim in your house and you have damage. This is what a doctor offers us. They run FebriDx, they submit the claim and then they get their reimbursement. And the fact is, we've just -- I'm thrilled that we are so far along, still work to do and CLIA waiver will only help us drive that. Next slide. So the WellStreet Urgent Care, this urgent care use case study has gone extremely well. And when it comes to a pilot like this, you really want to produce documented positive outcomes, right? That's the whole idea, like produce it, and then you bottle that up and you make it repeatable and you take it to another urgent care chain, if you will, organization. And so, so far with WellStreet, one, we've proven the model. and I'll get to the 2 boxes on the right here in just a second. And we also have an established pipeline of 8 other -- actually more than 8 now organizations with multiple sites that are watching very closely what we're currently doing with WellStreet. Okay? So let's move over and talk about WellStreet to the CLIA waiver rollout because the pilot has gone so well, and some of you may have seen the webinar with Dr. Brian Bobb of WellStreet, they are expanding to -- throughout Georgia and they're expanding to the entire state of Michigan and -- some, right around 50 sites, and that's immediate. So that's as of Friday, okay? They also are making FebriDx a standing order. If you come in with acute respiratory infection symptoms, you will get a FebriDx and then you'll be triaged from there. So the beautiful thing about WellStreet in this urgent care is one, Tommy Hall, our Director of Sales, has worked in this account has done a fantastic job of just positioning FebriDx. And there's a lot to it, right? There's the reimbursement. There's making sure the clinical utilities understood, the operational effectiveness, et cetera, it's gone so well that they're immediately expanding. And again, the goal is to keep doing this in tranches until they hit the 142, which according to Dr. Bobb maybe 187 by the end of fiscal year '27 as far as total locations, or it's going to continue to keep expanding in tranches. Next slide, please. So our FebriDx first protocol. This was established at WellStreet. This is the type of repeatable process I'm talking about as far as supplying it to other urgent care chains. And again, we already have hands raised for this. Patient presents, performing FebriDx, triaging accordingly between bacterial, nonbacterial and then, of course, you have severe atypical cases that need to be observed as well. So the actual protocol has been -- this is -- Dr. Brian Bobb presented this. This is the pathway they're currently using. This is the pathway they will continue to use and this is the pathway we're going to continue to share. Not every urgent care is the same, okay? But the nature of FebriDx and how it fits and how it's not disrupting physician behavior, it is an additional tool in their current workflow. That's very important. And Dr. Brian Bobb has expressed and he is working to help us spread the word, if you will, to these other organizations, too. Next slide. So the go-to-market strategy, we talked urgent care a little bit, but let's just say, well, what is that third prong? So you have the clinical utility, right, as Doug had said, too, as well, and that's your unmet need that we're addressing with FebriDx, 99% negative predictive value, great, check. Economics, we just check. More to do there, but great start. And then third, besides operational effectiveness is really awareness. We need to make sure that here, we have now this CLIA waiver novel test, not enough folks know about it. So how do we go about doing that? Well, we have a distribution network, as we said, of 2,000-plus field sales reps. We have engaged and contracted with a company called Share Moving Media that is a partnership just for distributor training and education, podcasts, 2-minute reels, a lot of digital media that helps with the training. And then we're also, as we speak, contracting with an outsourced group of RNs. It's going to be our clinical implementation team, and they are going to handhold these urgent cares, for example, from the receptionist all the way through to the back of the house, they call it, where the billing occurs and to make sure that on-site training has done very comprehensively with the clinical playbook. In other words, welcome to FebriDx. And so that's in the works, too. Then you have the reimbursement support I talked about briefly, PRO-spectus is doing an outstanding job of engaging with the payers and engaging with Medicare and Medicaid. And so think of that PRO-spectus as holding the hand on the front end. As soon as someone buys FebriDx, we introduced -- as soon as one of the accounts buy FebriDx, we introduced them to PRO-spectus and we even have a hotline set up between PRO-spectus and the account. And then from the claims standpoint, Acuity comes through and helps us determine where the claims have been submitted, what is the reimbursement for the product at that point. And so we feel like we've got help from the clinician on the front end and then closing the loop with Acuity on the back end, and I feel very good about the process. And as far as an awareness campaign, we are investing in a very robust brand awareness campaign that's going to target the 1 million U.S. physicians and the 4 million nurses, NPs, PAs, RNs, it's around taking -- working with a marketing adviser engaging with the agencies, which we're doing as we speak. In fact, we're already in the RFP process, and we're then going to choose an agency that has medtech experience different criteria such as a very robust analytics to measure the lead performance, Meta, Google, LinkedIn, journals, so many different criteria to be able to really drive the product. So we're very excited about that. And we're already well ahead of the game. And I'm hoping to tie that up by the end of April to really launch the FebriDx test. So hopefully, I didn't talk too quickly there, but at 6:35, I'm going to then move it over, Doug, to you for the next slide. I think you're on mute, Doug.
Douglas Ward
ExecutivesThanks, Paul. Appreciate that. Great overview. So just to sum it up again, right now, is, I think, the launch of what this company is going to be and what we've all dreamed of it since I came here 9 years in -- I mean, 3 years and 9 months ago, and it was to launch this. And from that day to today, it's been a challenging journey and we greatly appreciate all the support that everyone has given us. And now we're really, really excited about executing and delivering on that promise going forward. So why don't we just go quickly, if you don't mind, George, I just want to go through a couple of slides here on the capital raise. As you guys know, go to the next slide. please George. So let's just first start about the use of proceeds here. So listen, this was a very, very important strategic opportunity for the company to properly load the balance sheet and put cash in the bank so that we could deliver on this. Up until right now with CLIA waiver quite frankly, our company and our experience, my experience here has always been most cash has come through either nondilutive funding that we've been able to secure or unfortunately, we had to utilize things like convertible notes. And in our last raise, right, which was around $0.06, $0.07. We had 2 large investors came in and they had to underwrite a significant amount of the raise and so forth to keep us moving forward, and we appreciate all that. But now is the time that actually I'm really, really excited about being able to have the cash in the bank to drive those 2 critical items from my view and Paul's view and that is driving FebriDx marketing which we've never done and have never been able to do because we didn't have CLIA waiver nor did we have the funds to do it. Now is the time to do that because as the flu season is wound down here in the U.S. now we can prepare for next flu season and get that awareness out there so that when that starts, the physicians will be adopting the FebriDx test to help treat their patients right from the beginning. And the other critical element is the manufacturing scale up. Like I said, we have enough capacity for 2-plus years. But year 3, we would definitely need a lot more volume. And this will allow us to put that in place. And what's important about scale up in this field with a medical product, you have to get all of that in and you got to get all validated well ahead of time to go live as it is a regulated product and everything. So it could not be more thrilled with the current situation. Now let me talk about the important consideration for the retail investors, George, next slide. So number one, we are offering an SPP and a record date is from March 26. The documents -- SPP documents will be provided on Friday, April 10, and that will also begin the opening date for the SPP, and the close date will be Friday, the 24th with the results being provided on Friday, May 1. So we're very, very excited to bring this to all of our retail investors with identical terms, if you will, for the retail as well as from the institutional investors and making sure that the price point is the same, the options are the same and making sure that we give everyone a fair footing relative to the opportunity to invest in the company. So [ I will ] encourage you to do that. I think while we are sensitive to the fact that there are people who are disappointed that we did a raise at this time. I look at this more -- much more about putting this company in a position to deliver on the ultimate end game, which is driving the uptake of FebriDx into the U.S. market and you need cash to do that in the U.S. So very, very exciting, and I really look forward to as many people as possible participating in that. Okay. With that, George, I think we're wrapping up, and I'll give it over to you.
George Kopsiaftis
ExecutivesGreat. Thanks, Doug, and thanks, Paul, for that very comprehensive run through. I'd now like to just hand it over to Tracy, who will actually moderate the Q&A session.
Tracy Weimar
ExecutivesThank you, George. We've received a number of questions, both in advance and through the Q&A function. So thank you for that. A number of these questions relate to the capital raise. So Doug, I'd like you to speak to the points around the capital raise in particular, its size, the timing of it, the pricing, including the discount, the inclusion of options, the need for capital and the planned use of funds and some of the decision-making around that. So there's quite a few themes in there, but it would be useful if you could touch on each one.
Douglas Ward
ExecutivesYes. Absolutely. Let me just -- I'm going to first start with a comment, hey, listen, I wish no one was disappointed with the outcome of the CLIA waiver event as well as the capital raise. I wish that people were not disappointed. I think if you're really focused on the long-term opportunity for Lumos, this is -- we are now in a position that everyone has wanted us to be in, right? CLIA waiver and a balance sheet to be able to implement the CLIA waiver strategy for marketing and for manufacturing. So from that standpoint, even though there are people disappointed, and I wish they were not. I'm thrilled as the operator of the company and driving this forward. The minute we were able to get CLIA waiver, it was all hands on deck to say, okay, how can we make this the most successful launch that any of us have ever been around. So I'm thrilled with where we are. Now there were some questions in regard to, do we need funding period. And all I can say there is, listen, -- we -- I've been here 3 years, 9 months. We've always needed cash. I've never been with this company where we did not need cash in the bank. It was most recently and certainly in all of our quarterly updates, we always give our cash position. Most recently, we talked about the fact we had a drawdown on the loan facility that Ryder Capital and Tenmile were gracious to afford us. And quite frankly, at that time, right, we needed -- we knew that we would probably need some cash. And we didn't want to go out. I could be wrong, but I think our stock price back then was around $0.06. And that wasn't that long ago. And I think 9 months ago, our stock price was like $0.03. So it wasn't that long ago that we were in $0.02, $0.03, $0.04, $0.05, $0.06 range. And we knew that if we try to take more capital then, it would be extraordinarily right, dilutive to the business and our shareholders. So we did the loan facility. And we had to take $1 million out of that loan facility here, and we announced that in our last quarterly update. So I guess my take is, of course, we -- everyone could see that eventually, we would need more cash, but I think we also put it in the perspective of strategically no better time than while we're announcing a CLIA waiver. Once we got that, our ability to go ask for money was much more of an opportunity for us to secure that money putting it in the bank. So again, I feel great about that. Now people don't like some of the terms and so forth. And what I can say is, listen, we went to the market. We negotiated. Certainly, we were -- it was demand driven by sophisticated investors around the price point that they were willing to pay, receiving options, and moving that forward. And I would just say that my take on it was that Board was adamant about making sure that all investors would get those same similar terms around the price in the options, right? So I can just say, we're trying to create the most level field for everybody, in what we're offering, whether you like a percent discount or whatever listen, this is -- everyone is getting the same treatment. Everyone is getting the same opportunity from that standpoint, and I feel great about making sure that we did that. Now in regard to options themselves, I do understand that the price to execute those is at a premium 150%. And with that, that cash would come back into the company, right? And I think that's over AUD 15 million that would come back in. So again, that's only good for us, again, for our medium and long term for the company. And I'm here for the long haul, this stuff doesn't just happen overnight. It took us 3.5 years to get a CLIA waiver. We finally have a little bit of money in the bank account. And we won't go from 0 to $100 million over in sales either. It will take time in execution, but it's going to happen just like CLIA waiver happened. And we're very, very excited, and we think that this is going to be something that's going to be great for all of the long investors over time. So with that, Tracy, I think that, that gives the best response that I can to those questions that we received prior to this meeting.
Tracy Weimar
ExecutivesThank you, Doug. I guess a question on a different note regarding FebriDx is on sales and when we can expect the first sales results to come in and when these might be reported to shareholders?
Douglas Ward
ExecutivesYes. So the first sales after CLIA waiver, today is March 30 here in the U.S. So what I can say is that the next quarterly results will show some very nice numbers associated with sales since we did get CLIA waiver before the end of the quarter as we had said we would. And I can say that Paul is already delivering on his promises to the leadership team and to PHASE that we'd be able to supply the product to them and record those sales. So you'll see those numbers coming when we announce the quarterly results, but I can say Paul and I are very happy today with some very nice results.
Tracy Weimar
ExecutivesThanks, Doug. Another question relates to worldwide sales in non-U.S. markets. And if you can comment on that.
Douglas Ward
ExecutivesYes. They're actually growing year-on-year. So we feel very good about that. But I would just say, for those who haven't heard me talk about this before, and I don't know, Paul, if you want to add to this, but I ran point-of-care for Bayer in Europe when I lived there and everything. And the U.S. typically leads in this regard. And because it's -- I like Paul's phrase, right, cash follows care or care follows cash, I'm not sure what you said there. But I agree with it. And the reimbursement world is different, right, with the government-led say, institutions for health care in Europe. So they really need to know that a test is embedded in the care continuum. And once that's established in the U.S. and normally within short time, it really starts to take off ex U.S. We're just not even -- we haven't even started here in the U.S. So we are seeing sales there. There is growth year-on-year, and we continue to try grow that, but we won't see the kind of growth we really want there until we first have success in the U.S. and then eventually, we'll get more success in Europe.
Tracy Weimar
ExecutivesThank you, Doug. Just another question with regard to, say, the U.S. market. And since we've received the CLIA waiver, what's the response been so far in the U.S. market?
Paul Kase
ExecutivesWell, can you see the bags under my eyes, Tracy. We are -- I mean, it's busy. When I say busy, folks, I mean busy. Okay. So we soon a waiver. I was in Orlando, Florida with Henry Schein. I'm in Louisville, Kentucky now with MTMC, making sure all these folks are fully ready to go by Wednesday, and they are off and running. We've got NBC next week at Nashville and training. I've got McKesson. And then I've got, I don't know, a little urgent care show, which is the biggest in the country in Chicago in 2 weeks. So it has been the activity, Tracy, and to everyone, it's so robust. It's unbelievably robust. In fact, I'm sure I'll check my text and I'll have 30 just in the time that we're talking here. And I couldn't be any more pleased. And so it's just a matter of staying focused, though, and not letting some distractors maybe distract you. But we are -- I couldn't be any more pleased with the number of calls and from urgent care chains from all different markets that can't wait to move forward with FebriDx. As I said, a lot of that prep work, with the painting analogy was done. We've talked to many of these folks. And many of them said, "Hey, make us your first call when you get the waiver and now they're reaching out." So I'm very excited about it. Very excited.
Tracy Weimar
ExecutivesThank you, Paul. I'm conscious of time and that we've covered the themes in the questions as much as we've been able to and just handing it back to Doug for some final words.
Douglas Ward
ExecutivesYes. Listen, everyone, this is a great moment for the company, right? I feel so we've been working really hard, and we've achieved this CLIA waiver now again, the hard work begins again in terms of implementation and moving forward. Listen, I really do appreciate the support from our investors and certainly our long retail investors that has meant the world to us. And at the same time, listen, I think it's still -- Lumos is still a great opportunity to invest in. And hopefully, with the SPP, people have that opportunity to come in and invest in. I'd love and appreciate to see that. And just so that you do know as well, I'll probably be out there certainly this coming quarter. And we'll certainly be announcing some opportunities to make sure that there is some time for face-to-face meetings and discussions and so forth and not right, boxed into this time frame that we have here today. But I do sincerely appreciate it. And on behalf of both Paul and myself, thank you very much, everyone.
Paul Kase
ExecutivesYes, thank you.
George Kopsiaftis
ExecutivesGreat. Thank you, Doug. Thanks, Paul, and thanks, Tracy, for that update. We do look forward to catching up with everyone again in -- by the end of April when we report our third quarter results. And again, as Doug said, he will be here probably sometime in May. So we look forward to Doug's arrival in Australia. With that, I'd like to conclude today's webinar, and thank you all for participating.
Douglas Ward
ExecutivesThanks, George.
Paul Kase
ExecutivesThanks, George. Thanks, everyone. Bye.
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