NASDAQ:XGN Exagen Q1 2024 Earnings Report $6.88 +0.23 (+3.46%) Closing price 04/29/2025 04:00 PM EasternExtended Trading$6.94 +0.06 (+0.81%) As of 08:37 AM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Exagen EPS ResultsActual EPS-$0.19Consensus EPS -$0.40Beat/MissBeat by +$0.21One Year Ago EPSN/AExagen Revenue ResultsActual Revenue$14.42 millionExpected Revenue$13.20 millionBeat/MissBeat by +$1.22 millionYoY Revenue GrowthN/AExagen Announcement DetailsQuarterQ1 2024Date5/13/2024TimeN/AConference Call DateMonday, May 13, 2024Conference Call Time8:30AM ETUpcoming EarningsExagen's Q1 2025 earnings is scheduled for Monday, May 12, 2025, with a conference call scheduled on Monday, May 5, 2025 at 8:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Exagen Q1 2024 Earnings Call TranscriptProvided by QuartrMay 13, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Please note this conference is being recorded. I will now turn the call over to Ryan Douglas with Investor Relations. Ryan, you may now begin. Speaker 100:00:10Good morning and thank you for joining us. Earlier today, ExGen Inc. Released financial results for the quarter ended March 31, 2024. The release is currently available on the company's website at www.exxgen.com. Jon Abali, President and Chief Executive Officer and Kamal Adawi, Chief Financial Officer will host this morning's call. Speaker 100:00:33Before we get started, I would like to remind everyone that management will be making statements during this call that include forward looking statements within the meaning of federal securities laws, which were made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward looking statements. All forward looking statements, including without limitation, statements regarding our business strategy, future financial and operating performance, including guidance, potential profitability, our current and future product offerings and reimbursement and coverage are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. Speaker 100:01:23For a listen description of the and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission, including our Form 10 ks for the year ended December 31, 2023, our Form 10 Q for the quarter ended March 31, 2024 and any subsequent filings. In addition, some of the information discussed today include non GAAP financial measures such as adjusted EBITDA that have not been calculated in accordance with generally accepted accounting We believe these metrics provide useful supplemental information in accessing our revenue and operating performance. Reconciliations of these non GAAP financial measures to most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which have been posted to the Investor Relations page of the company's website. The information provided in this conference call speaks only to the live broadcast today. ExoGen disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward looking statements, whether because of new information, future events or otherwise. Speaker 100:02:35I will now turn the call over to John Abali, President and CEO of ExoGen. Speaker 200:02:41Thanks, Ryan, and to everyone for joining the call. Here at ExoGen, we've executed another fantastic quarter. And today, I plan to discuss our results, provide updates on our path to profitability and give further details on the enhancements we're making to Advise CTD. I'll then hand it over to Kamal, our Chief Financial Officer, for details on our financial performance. We had a great start to 2024 and for Q1, I'm happy to report that total revenue was $14,400,000 driven by a strong increase in Advise CTD ASP. Speaker 200:03:16Our trailing 12 month ASP is now $3.77 per test, which is up 35% or almost $100 we have built as we work towards profitability. Our adjusted EBITDA for the Q1 was a negative $2,000,000 This is also a significant improvement over the same period last year and a testament to the impact ASP improvements are having on our bottom line. The progress we've made on our ASP is substantial and execution on our strategy has continued to dramatically reshape the operating profile of the company over the past year. Volume for Advise CTD in the Q1 was just over 30,000 tests, which was essentially flat from the Q4 of 2023. However, we did see volume increase in each month of the Q1 and that momentum continued into Q2. Speaker 200:04:18At this point, we have fully recognized the impact to volume we expected to see as a result of the changes we made in the middle of last year and are confidently seeing testing growth again. Over the coming quarters, we anticipate our volume continuing to build as our team works to improve ordering efficiencies and educate physicians on the clinical value proposition of Advise CTD. During the last earnings call, we briefly touched on improvements we're planning to make to our Advise CTD offering. And I'd like to provide additional details as we believe these enhancements will be very positive for customers and our organization. We currently plan to add 3 T cell markers for SLE and additional new markers for rheumatoid arthritis to the Advise CTD offering in the Q4 of this year. Speaker 200:05:06These new markers have been clinically validated and we're working through the operational logistics of adding them to our core product. The benefits of these new markers will be multifaceted. 1st, we gain enhanced IP protection in offering some of the most sensitive markers to aid in the diagnosis of systemic lupus erythematosus. 2nd, our overall product improves in terms of clinical utility, which we expect to lead to increased adoption over time. And third, we anticipate these additional markers will be accretive to our financial performance, both in terms of top and bottom lines. Speaker 200:05:45In regard to the improved clinical utility that we expect for Advise CTD, it helps to refresh that we've demonstrated in multiple published validation studies that the current sensitivity of Advise CTD is 80% with standard of care markers ranging from 14% to 44%. We're in the process of publishing data that will show how the introduction of T cells will significantly enhance the sensitivity of Advise CTD. The improved sensitivity of these markers will help clinicians diagnose lupus patients sooner. The patent protection on the T cell markers continues through 2,035 making their proprietary nature durable for the next decade plus. Additionally, Advise CTD currently includes traditional markers to aid in the diagnosis of rheumatoid arthritis and our markers identify approximately 70 percent of RA patients. Speaker 200:06:38This leaves roughly 30% of RA patients who would be seronegative with no current diagnostic biomarker commercially available. We plan to add new RA markers in the Q4 of this year, which we believe will allow us to improve the sensitivity of our rheumatoid arthritis assays and correctly identify 80% to 83% of total RA patients or up to a third of the traditional seronegative population. We believe this level of diagnostic performance is unmatched in alternative commercially available options and will continue to demonstrate to our clinicians our commitment to providing them the best quality testing with 1st in class performance. Altogether, these new markers substantially increase the utility of Advise CTD, which we believe will lead to increased product adoption. Our commercial team is preparing for the launch of these products. Speaker 200:07:32Our sales organization is eager to educate clinicians on the gain in clinical value. And our laboratory is working through the operational requirements to offer these novel markers at scale from launch. We expect the impact to CTD demand will likely be slow at first, marrying the pace of educational progress amongst our base of clinicians, but increasing over time. We're very excited to bring these innovations to patients, signifying the next phase of growth at Exigent. I'd also like to briefly touch on the FDA's proposed rule that became final a few weeks ago. Speaker 200:08:07We believe we are well situated to handle the additional regulatory requirements as our laboratory is CLIA, CAP and New York State certified and we perform several assays which are currently FDA approved. Broadly, we believe this regulation will create a barrier to entry for competitors in our market because it increases the resources required for commercialization of lab developed tests. We continue to monitor the development of these rules and do not currently anticipate any major impediments to executing our plan. Lastly, I'd like to thank Brian Burke, Doctor. Beto Poyedes and Wendy Johnson for their years of service, numerous contributions and guidance to XGen as they transition off our Board of Directors. Speaker 200:08:53Since I joined the company in late 2022, they have been integral in making the necessary changes to focus on achieving profitability and have been extremely supportive throughout my time here. Additionally, I'd like to welcome Doctor. Scott Kahn to our Board and look forward to leveraging his unique skill set and experience as we move to our next phase of growth. I'll now turn the call over to Kamal for details on our financial results. Speaker 300:09:20Thank you, John, and good morning, everyone. As John mentioned, it was a strong start to the year with total revenues in the Q1 of 2024 of 14,400,000 compared with $11,200,000 in the Q1 of 2023, a 28.4% increase. Total revenues were driven by record ASPs for Avaya CTD tests. Other testing revenue was 1,500,000 the Q1 of 2024 compared with $1,400,000 in the Q1 of 2023. Improvements to our revenue cycle continued to yield results as we collected approximately $700,000 from prior period collections from tests performed over a year ago. Speaker 300:10:03Cost of revenue were $5,800,000 in Q1 2024 resulting in total gross margin of 59.6 percent compared to 47.2 percent in Q1 2023. The increase in gross margin was driven by increases in ASP. Operating expenses excluding COGS for the Q1 of 2024 were $11,600,000 compared with $13,000,000 in Q1 2023. Year over year decreases were primarily due to a reduction in employee related expenses as a result of decreases in headcount. The net loss in Q1 2024 was 3,400,000 dollars compared with $7,700,000 in Q1 2023. Speaker 300:10:48Adjusted EBITDA was negative $2,000,000 for the Q1 of 2024 compared to negative $6,200,000 for the Q1 of 2023. As a reminder, our adjusted EBITDA excludes stock comp expense since it is a non cash expense for the organization. Please refer to our earnings release issued earlier today for a reconciliation of adjusted EBITDA to net loss. Looking to our balance sheet, cash and cash equivalents as of March 31, 1, 2024 were approximately $27,300,000 and our accounts receivable balance increased to $10,900,000 As we communicated in March, we fully anticipated the increase in AR and decrease in cash as we hold claims in the first half of the year as part of our revenue cycle management initiatives. This remains consistent with the strategy we employed last year and we anticipate this trend to continue in Q2 and begin to reverse in the second half of the year, similar to what we saw in 2023. Speaker 300:11:49I'm very happy with the start of the year as all key metrics continue to trend in the right direction. For full year 2024 revenue, we're raising guidance from approximately $54,000,000 to at least $55,000,000 We're also updating our adjusted EBITDA guide and now believe it will be better than negative $18,000,000 an improvement from our prior guidance of better than negative 20,000,000 dollars We reiterate our belief that our existing cash and cash equivalents are sufficient to meet our anticipated cash requirements into 2026. We will now open the call for questions. Operator00:12:26Thank you. We'll now be conducting a question and answer session. Thank you. And our first question today is from the line of Mark Massaro with BTIG. Please proceed with your questions. Speaker 400:13:01Hey guys, thank you for the questions and congrats on the quarter. The first one I think is on the new product launch with the T cell markers. I know you talked about it on the prior quarter call, but I'm sure you've had some time perhaps to think about how this might expand your market opportunity. I know certainly if you're able to diagnose earlier, perhaps could have increased clinical utility on some of the existing sets of customers that you're selling to. But can you just maybe expand a little more on the RA? Speaker 400:13:39Is this incremental to the size of the market and the patient type that you're going after? And can you perhaps help us think about how this can fit in and potentially expand your market opportunity? Speaker 200:13:55Hey, Mark. Good morning. Thanks so much for the question and opportunity to expand. Appreciate you joining the call as well. So when I joined the organization, we took a methodical approach to reviewing every aspect of our business and to specifically evaluate the opportunity in the market against the technology and projects we had ongoing internally. Speaker 200:14:17We start with the customer need and I truly believe that's important. It's a simple concept. It's out there in plain sight, but it can be hard to maintain this acorn point as you get into the thick of development. Certainly, I've had that experience. The science doesn't always work out as you draw it up, etcetera. Speaker 200:14:35But with both of these new marker efforts, we understand the customer need and we're building on the back of a proven, well adopted product in Advise CTD. We said consistently our market there is for ANA positive referrals into rheumatology. From a prevalence standpoint, that's roughly 41,000,000 Americans in the U. S. Up to a third of RA patients present with a positive ANA test. Speaker 200:15:01So this very much is in the wheelhouse of diagnostic utility within connective tissue disease. And our strategy across the organization has really been how do we make Advise CTD better. Whether that's with new markers such as these, whether we're improving our service with our sales and customer facing groups or even with our ASP efforts. We've gone all in and improving this part of our business and studying how Advise CTD is used clinically. And that's led us to want to strengthen that aspect, both in terms of what we can provide for diagnostic sensitivity of SLE and in rheumatoid arthritis. Speaker 200:15:41For RA, you have established markers used in the diagnosis of RA such as anti CCP antibodies, various rheumatoid factors. These are part of Advise CTD today. We also offer a fairly unique anti carbamylated protein or anti CARP as it's more commonly referred to, which helps improve the sensitivity in identifying suspected RA patients. But there's approximately 30% of RA patients, which are diagnosed without any serologic positivity. And this group of patients can be challenging clinically. Speaker 200:16:15This is exactly what these new markers aim to do. And as we said on the call, we anticipate capturing around a third of that what is today seronegative RA patient population and that should be industry setting performance. So very additive to Advise CTD. Speaker 400:16:34Got it. All right. Awesome. That's helpful. And then, obviously, you guys had a nice quarter. Speaker 400:16:40You exceeded My and Street expectations. Looks like a lot of this was driven by the ASP expansion. So for Kamal, look, I think I heard you say that you collected $700,000 from prior period collections. When I think about your raised guidance, are you expecting any other prior period collections for the rest of this year? And then even if you are not including it in guidance, how do you think about the potential opportunities to collect from prior periods? Speaker 400:17:12I know elsewhere in diagnostics land this quarter, I saw quite a few labs in my coverage that collected material amounts from prior periods. So how should we think about that opportunity set? Speaker 300:17:26Hi, Mark. Thanks for the question. Yes, we collected $700,000 in Q1 of 2020 4. Keep in mind, we had collected about $5,000,000 between Q2 2023 and Q4 2023. So we've seen that number come down in Q1. Speaker 300:17:46When we gave guidance last quarter, we made it clear that we don't factor in prior period collections into our guidance estimate and we didn't do that again this time. Just because of the visibility into collecting on prior period collections, it's very challenging to forecast that. And we did say over time, we expect that number to get closer to 0. So we weren't going to factor that into the guidance. Speaker 400:18:16Yes, that makes sense. And then maybe one more for you, Kamal. Do you still think that you can achieve cash flow breakeven at annual revenue of $75,000,000 60% gross margins? Speaker 300:18:31We had a great Q1 on gross margins, 59.6 percent. And over the last several years, you probably heard me say over and over again that usually you see the lowest gross margin in the Q1 because of seasonality, because deductibles resetting Q1. However, our strategy with revenue cycle management of holding claims has offset that seasonality impact on the gross margins and we didn't see that negative impact in Q1. So I was very pleased with that number of almost 60% on the gross margin. Now I used to say we build off that Q1 number. Speaker 300:19:09We're going to have a little bit of lumpiness with gross margins just because of that prior period collection number, but I'm very excited with how well we did at 59.6%. And when we do get to profitability, we always put that $75,000,000 revenue number and 60% gross margin figure as a goal. We've exceeded our internal expectations on the gross margin number. So as we get towards profitability, means our revenue number is going to come down slightly. Which means our revenue number is going to come down slightly. Speaker 400:19:43Yes, that makes sense. All right. Thanks so much guys. Operator00:19:48The next questions are from the line of Kyle Mixon with Canaccord Genuity. Please proceed with your questions. Speaker 500:19:55Hey guys, thanks for the questions. Congrats, really great quarter. Yes, just on that note, Kamal with the gross margin, if you take out the 700 ks prior period collections, it looks like the core gross margin was like high 50s, maybe 58%. I mean in the past, the core margin was like 50%. I think last quarter, if you take out the prior period collections, maybe 50% was the margin. Speaker 500:20:16So maybe just talk about what an organic gross margin looks like when you take out some of these prior period revenues? And just how to think about that going forward, what that means for the profitability kind of formula going forward? Speaker 300:20:30Sure. Thanks for the question, Kyle. Yes, so we still are exceeding what we have rejected internally in terms of gross margins even with the $700,000 taken out. So our ASPs have trended up considerably even without prior period collections. It's up almost $100 year over year. Speaker 300:20:53So we've been making great strides. It's obviously our gross margin isn't all being driven by that prior period collections. It's the ASP is the biggest contributor to the gross margin though, but not all from Speaker 600:21:08prior period. Speaker 500:21:09Yes. Okay. Thanks, Paul. And then John, on the, I guess, monthly volume levels, you said increased month over month, each month during 1Q, maybe like on an annualized basis, maybe March was ahead of 30 Speaker 600:21:24ks or so. I mean, Speaker 500:21:25can you just talk about maybe with some quantitative commentary like how we should think about the exit rates in March for volume and maybe we saw recently in April May? Speaker 200:21:36Hey, Kyle. Good morning. Thanks for joining the call. Appreciate the question. So we made changes just to give context why we're seeing some of these volume trends. Speaker 200:21:45We made changes to our process in 2023 in an effort to improve ASP for Advise CTD. And this is with a long run mentality or viewpoint. We're trying to operate a more profitable business and it's clearly working. There's more to come. And so this was absolutely the right approach to take and I'm very encouraged about our progress over the past 15 months. Speaker 200:22:09We did with these changes expect some temporary impact to volume as you said as we work with various accounts to adjust and as we focus our sales team on making these changes smooth. In the past and we're returning to this more traditionally now, our normal sales focus is in the pursuit of new business. And so that's occurring. We've moved more in that direction. I expected Q4 of 2023 to be the low point in terms of this temporary volume correction, and that's essentially exactly what we saw. Speaker 200:22:41It carried over a little bit to the 1st couple of weeks in January, but we had a strong end of January. February grew further. March was the height of the quarter. Our momentum has continued into Q2, and I'm very confident that we've returned to growth driven by a combination of ASP and volume improvements. We don't guide on volume per se, but this is exactly what we expected. Speaker 200:23:06To be honest, it's fun to be operating a more profitable business with a clear path to profitability and strong growth. And so we're very excited with the trajectory we're on. Speaker 500:23:17Okay, great. And quick side note, was did ASP remain pretty healthy in each month or did that decline sequentially? Speaker 300:23:27So with our ASP being on accrual methodology, we look at that monthly, but we don't make the final adjustments until the end of the quarter. So we'll be ready to comment on that at the next earnings call. There is nothing that we saw that would make me concerned with the ASP number going in a different direction than what you've seen over the past 4 quarters. Speaker 500:23:56Okay. That's good. Final one, John, just given this FDA final rule, I think you talked about that a little bit in your remarks. Just wondering impact to your pipeline. I know that it was kind of the emphasize in recent years a bit, but that I feel that remains an important part of the growth strategy long term. Speaker 500:24:11So maybe just talk a bit about how you're thinking about investing in the pipeline and kind of a future test and stuff including some of these new markers? Speaker 200:24:19Thanks, Carl. Very relevant question, really good question, something that we're evaluating and working to get smarter on, on a daily basis around here. To be clear, we're still studying the exact implications of the rule to best understand the potential strategic impacts it will have on our approach. I think there's a very real opportunity that this provides advantages for us and I want to better understand those. But then also I think maybe a little more to your question was around which gaps and what would it take to comply over the phase out period specifically relevant to our development efforts. Speaker 200:24:58So as it pertains to our development efforts or I guess not currently marketed would be the language used there, part of our pipeline. Like I said, we're still working through some clarifying points. The FDA itself is hosting a webinar tomorrow to clarify some of the details around the final rule. So even information out of the FDA is still, percolating. But we continue to be confident that our approach to developing LVTs and specifically our track record of meeting the requirements of New York State Certification will allow us to remain on track with our communicated timelines. Speaker 200:25:32So there will be some upgrades required we anticipate to our quality management systems, it appears. Again, that's likely over the next year or 2. But again, we're still working through all of these details over the coming months. We have the right resources to support our information gathering. And as we evaluate impacts to our strategic approach, we'll keep everyone apprised. Speaker 200:25:52We do believe that in the long run, final rule, this is likely to be a competitive advantage for us as it raises the bar in some respect to new entrants and LDT development. Speaker 500:26:05Perfect. That's helpful. Thanks, John. Thanks, guys. Speaker 700:26:08Thanks, Kyle. Operator00:26:10The next question is from the line of Dan Brennan with TD Cowen. Please proceed with your question. Speaker 700:26:16Great. Thanks for the questions. Congrats on the quarter. Maybe the first one on price. I think I heard you guys just mention that there's no reason the recent 4 quarter trend can't continue. Speaker 700:26:27So if we strip out the prior periods, it looks like price in Q3 went up $29 sequentially, Q4 up $40 and then this quarter up 40. So is the expectation that price will continue to climb from here? I know you're still withholding some claims, but did I hear you guys correctly on that? Speaker 200:26:46Good morning. So we are still holding claims. We do this for various internal reasons, which we think optimize our ability to collect cash relative to those claims. We've had tremendous growth on the ASP side. You just I appreciate you throwing out there those numbers. Speaker 200:27:06From our perspective, we're working hard on the processes that we know will pay off long term. We know how to do this strategically. We know how to operate very sound revenue cycle practices. And that's a big part of what I brought to the organization in coming here. It takes some time to get these things in place. Speaker 200:27:23We're very content and happy with how that progress has materialized, but we expect it to continue. Whether it will continue exactly in those proportions, ASP is an inherently difficult metric to forecast. That's part of the reason why we do the or point folks to the trailing 12 month metric. That's part of the reason why we don't provide guidance specifically related to ASP. We can have material wins at any given time in the future. Speaker 200:27:51The lower hanging fruit tends to be consumed, right, here in the early phases. And then it gets a little bit harder as time goes on. But we still are very optimistic internally that we have the right strategy in place to drive ASP higher over the long term. And again, looking at that trailing 12 month number is likely to give you a very good insight into the trend over time. Speaker 700:28:15Great. Thanks for that. And then maybe one just on volume. So just to be clear, it sounds like you're basically indicating that the volume growth that you've seen, you expect volumes to continue to climb sequentially from here. I mean, it might not be linearly, but is that the expectation that's kind of what you're thinking about for 2024? Speaker 200:28:31Yes, that's a very fair assumption. Speaker 700:28:35Got it. Okay. And then on the new markers, like could there be any impact on price over time? Would you look to refile and given you have greater utility that you might look to get a better price? And I know you sounded pretty excited you'll start to market these kind of this year and then into next. Speaker 700:28:51But could you also just help us think through I know you gave some color around the new market opportunity that you have, but just in terms of magnitude, like what kind of impact could these has as we look out in 2025 and 2026? Speaker 200:29:05That's a great question. At the surface, yes, we're extremely excited. We fully expect these new markers to be accretive to our individual, advised CTD pricing that are therefore top line certainly gets impacted. They'll be margin accretive as well. So these are very positive from a financial performance standpoint. Speaker 200:29:27And again, this is me super excited. So I'm trying to convey that from my standpoint. I think what the impact that these markers will have clinically, they're the most sensitive markers on the T cell side, they're the most sensitive markers for detection of SLE. On the rheumatoid arthritis side, This is sets the standard in the industry from our perspective. So to hit both of those milestones clinically, that's huge. Speaker 200:29:52And then to have it be a significant benefit for the organization we expect, I think this is a no brainer internally and something that we're we've got laser focused internally in getting these markers out as soon as possible sometime here in Q4. We're not ready to guide at any point right now on the financial impact. Really, especially since we don't have a solidified launch date and we're still working through the optimization in our lab, which could change some of the COG profile, etcetera. So but you're exactly right, 25, 26, this will be very substantial for the organization. Speaker 700:30:32Great. Okay. Thanks, guys. Operator00:30:36Our next questions are from the line of Andrew Brackmann with William Blair. Please proceed with your questions. Speaker 600:30:42Hi, good morning. This is Dustin on for Andrew. Thanks for taking our First question on the guide. Just wondering what your spending priorities are for the year given adjusted EBITDA came in better than expected minus $2,000,000 but the full year guide is at minus 8 or better than minus $18,000,000 for the year? Thank you. Speaker 200:31:04Hey, Dustin, good morning. Thanks for joining. Appreciate that. If you take a look at R and D, and Kamal can comment a little bit on OpEx and SG Speaker 500:31:13and A and Speaker 200:31:13stuff. But if you take a look at R and D in Q1, we still spent $1,000,000 That's consistent with what we said historically, annual expenditures approaching kind of that $5,000,000 $6,000,000 range. That's sufficient to bring the new markers to market, T cells along with RA. Those costs have already been baked in. They're included in that number. Speaker 200:31:35And then we also have a few other projects in our pipeline around disease activity in SLE along with continuing to push along some of the technology that we licensed out of Johns Hopkins. So we're not rolling back the development that we need for future growth. Organizationally, we're still spending to keep our instrumentation in the lab very relevant, very up to date. From a guidance standpoint, how that factors into the negative 18%, we're extremely proud maybe one thing to start off with. We're extremely proud of the progress here in Q1 and our ability to deliver strong revenue growth and I guess ever contracting adjusted EBITDA loss. Speaker 200:32:23But just over a year ago, we were averaging about $10,000,000 negative $10,000,000 per quarter in adjusted EBITDA. Last year, we cut that in half to a negative $5,000,000 per quarter on average. So from our perspective, the recent trends have to be kept in context, we believe, especially since we had approximately $5,000,000 in prior period collections aiding our numbers last year. So while we have continued to outpace even our internal projections, our progress will bounce around a little bit and we're not quite ready to establish a new run rate in terms of adjusted EBITDA. But we do feel very confident that we will achieve our goals and we're working to do so ahead of expectations is maybe how I mentioned that. Speaker 200:33:04And Doug, I'll just add. We've been very prudent with our expense control on our pathway to Speaker 300:33:09profitability. When looking at SG and A and R and D, I would just factor in small expense increases quarter over quarter mainly due to inflationary increases. Speaker 600:33:24Okay, makes sense. Thanks for that. And then maybe wondering if you can talk a little bit about sales force productivity. You made some changes to the organization over the last year. So is there any color you can add on how we should be thinking about driving further productivity from here? Speaker 200:33:43It's a great question. So just to give a sense of our current sales footprint across the U. S, when I joined the organization in late 2022, we had 63 territories. We did an evaluation to take a look at how we would breakeven across the various territories and at least cover the cost of the sales rep. We consolidated those 63 down to 40 in December of 2022, and we've been operating at that level since. Speaker 200:34:09We've really been working to coach and drive 2023. So we feel that 40 is the right number for us right now. We're still working through some of the adjustments that we made in July regarding our billing policy. And so as I've mentioned, our team is heavily focused on ensuring that each individual account is serviced well and that these transitions are smooth. As we return more to, I guess, hunting mindset, pursuit of new business mindset, more traditional approach from the sales standpoint, we've got the right footprint for some time here and certainly have the ability to grow with this existing footprint. Speaker 200:34:59As we move into higher levels of profitability within each territory, then we'll expand kind of empirically from there. Speaker 600:35:12Okay. One last one for us. Just what assumptions are you guys making either strategically or financially for the increased education for the new markers you're planning on adding later this year? Thank you. Speaker 200:35:26That's a good question as well. From our standpoint, we just we believe our current expense profile is sufficient to launch these new markers. There may be some additional conferences we attend. There may be some small advertisements that we do on relevant to the rheumatology community. But from our standpoint, there's not a huge need to have an outsized expenditure related to the launch of these products. Speaker 200:35:56We're preparing a manuscript. We think the science is really where you need to start in the messaging. Our sales team knows our current product extremely well. So layering on additional clinical utility evidence is just part of the evolution of the knowledge of our product. So from our standpoint, I wouldn't expect SG and A to change much. Speaker 600:36:22Okay. That's it from us. Thank you. Operator00:36:27Thank you. At this time, we've reached the end of the question and answer session. Now I'll turn the call over to John Abali for closing remarks. Speaker 200:36:34Thanks. We're off to an excellent start to the year. My confidence and optimism continue to build as our organization evolves and undergoes substantial improvements. We've set ourselves up for sustainable growth throughout the changes we made last year and with the updates planned for Advise CTD this year. Will continue to accelerate that growth. Speaker 200:36:54It's encouraging to see the devotion within the ExoGen team and I truthfully could not be more excited for our future. Thanks so much for joining the call today. Operator00:37:04This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallExagen Q1 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Exagen Earnings HeadlinesExagen Inc. Announces Senior Secured Credit Facility with Perceptive AdvisorsApril 28 at 9:00 AM | globenewswire.comExagen: Buy An Undervalued Diagnostics Developer That Is On The Path To ProfitabilityApril 26, 2025 | seekingalpha.comFeds Just Admitted It—They Can Take Your CashHere’s the cold truth: If your money is sitting idle in a bank account, it’s vulnerable. That’s why thousands of smart, forward-thinking individuals are making the move—out of the system and into real, untouchable assets. Because once your funds are frozen, it’s too late.April 30, 2025 | Priority Gold (Ad)Institutional investors control 30% of Exagen Inc. (NASDAQ:XGN) and were rewarded last week after stock increased 30%April 25, 2025 | finance.yahoo.comExagen Inc. to Announce First Quarter 2025 Financial Results on May 5, 2025April 21, 2025 | globenewswire.comExagen Inc. (NASDAQ:XGN) Just Reported Annual Earnings: Have Analysts Changed Their Mind On The Stock?March 14, 2025 | finance.yahoo.comSee More Exagen Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Exagen? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Exagen and other key companies, straight to your email. Email Address About ExagenExagen (NASDAQ:XGN) develops and commercializes various testing products under the AVISE brand in the United States. The company enables healthcare providers to care for patients through the diagnosis, prognosis, and monitoring of autoimmune and autoimmune-related diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). Its lead testing product is AVISE CTD that enables differential diagnosis for patients presenting with symptoms indicative of various connective tissue diseases (CTDs) and other related diseases with overlapping symptoms. The company offers AVISE Lupus that measures activation of the complement system by quantifying the level of B-cell C4d and erythrocyte bound C4d in the patient's blood; and AVISE APS, which consists of a panel of autoantibody tests that aids in the diagnosis and management of APS. In addition, it provides AVISE Vasculitis AAV, which utilizes a testing panel of individual analytes to provide physicians with results in the assessment and monitoring of anti-neutrophil cytoplasmic antibody associated vasculitis; AVISE SLE Prognostic, a panel of autoantibodies for assessing the potential for complications affecting the kidney, brain, and cardiovascular system; and AVISE Anti-CarP test, which identifies RA patients with severe disease. Further, the company offers AVISE SLE Monitor, a biomarker blood test; AVISE MTX, a patented and validated blood test; and AVISE HCQ, a blood test to monitor levels of hydroxychloroquine. It has a research collaboration and license agreement with Allegheny Health Network (AHN) Research Institute to develop novel patented biomarkers. The company was formerly known as Exagen Diagnostics, Inc. and changed its name to Exagen Inc. in January 2019. 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There are 8 speakers on the call. Operator00:00:00Please note this conference is being recorded. I will now turn the call over to Ryan Douglas with Investor Relations. Ryan, you may now begin. Speaker 100:00:10Good morning and thank you for joining us. Earlier today, ExGen Inc. Released financial results for the quarter ended March 31, 2024. The release is currently available on the company's website at www.exxgen.com. Jon Abali, President and Chief Executive Officer and Kamal Adawi, Chief Financial Officer will host this morning's call. Speaker 100:00:33Before we get started, I would like to remind everyone that management will be making statements during this call that include forward looking statements within the meaning of federal securities laws, which were made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward looking statements. All forward looking statements, including without limitation, statements regarding our business strategy, future financial and operating performance, including guidance, potential profitability, our current and future product offerings and reimbursement and coverage are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward looking statements. Accordingly, you should not place undue reliance on these statements. Speaker 100:01:23For a listen description of the and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission, including our Form 10 ks for the year ended December 31, 2023, our Form 10 Q for the quarter ended March 31, 2024 and any subsequent filings. In addition, some of the information discussed today include non GAAP financial measures such as adjusted EBITDA that have not been calculated in accordance with generally accepted accounting We believe these metrics provide useful supplemental information in accessing our revenue and operating performance. Reconciliations of these non GAAP financial measures to most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which have been posted to the Investor Relations page of the company's website. The information provided in this conference call speaks only to the live broadcast today. ExoGen disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward looking statements, whether because of new information, future events or otherwise. Speaker 100:02:35I will now turn the call over to John Abali, President and CEO of ExoGen. Speaker 200:02:41Thanks, Ryan, and to everyone for joining the call. Here at ExoGen, we've executed another fantastic quarter. And today, I plan to discuss our results, provide updates on our path to profitability and give further details on the enhancements we're making to Advise CTD. I'll then hand it over to Kamal, our Chief Financial Officer, for details on our financial performance. We had a great start to 2024 and for Q1, I'm happy to report that total revenue was $14,400,000 driven by a strong increase in Advise CTD ASP. Speaker 200:03:16Our trailing 12 month ASP is now $3.77 per test, which is up 35% or almost $100 we have built as we work towards profitability. Our adjusted EBITDA for the Q1 was a negative $2,000,000 This is also a significant improvement over the same period last year and a testament to the impact ASP improvements are having on our bottom line. The progress we've made on our ASP is substantial and execution on our strategy has continued to dramatically reshape the operating profile of the company over the past year. Volume for Advise CTD in the Q1 was just over 30,000 tests, which was essentially flat from the Q4 of 2023. However, we did see volume increase in each month of the Q1 and that momentum continued into Q2. Speaker 200:04:18At this point, we have fully recognized the impact to volume we expected to see as a result of the changes we made in the middle of last year and are confidently seeing testing growth again. Over the coming quarters, we anticipate our volume continuing to build as our team works to improve ordering efficiencies and educate physicians on the clinical value proposition of Advise CTD. During the last earnings call, we briefly touched on improvements we're planning to make to our Advise CTD offering. And I'd like to provide additional details as we believe these enhancements will be very positive for customers and our organization. We currently plan to add 3 T cell markers for SLE and additional new markers for rheumatoid arthritis to the Advise CTD offering in the Q4 of this year. Speaker 200:05:06These new markers have been clinically validated and we're working through the operational logistics of adding them to our core product. The benefits of these new markers will be multifaceted. 1st, we gain enhanced IP protection in offering some of the most sensitive markers to aid in the diagnosis of systemic lupus erythematosus. 2nd, our overall product improves in terms of clinical utility, which we expect to lead to increased adoption over time. And third, we anticipate these additional markers will be accretive to our financial performance, both in terms of top and bottom lines. Speaker 200:05:45In regard to the improved clinical utility that we expect for Advise CTD, it helps to refresh that we've demonstrated in multiple published validation studies that the current sensitivity of Advise CTD is 80% with standard of care markers ranging from 14% to 44%. We're in the process of publishing data that will show how the introduction of T cells will significantly enhance the sensitivity of Advise CTD. The improved sensitivity of these markers will help clinicians diagnose lupus patients sooner. The patent protection on the T cell markers continues through 2,035 making their proprietary nature durable for the next decade plus. Additionally, Advise CTD currently includes traditional markers to aid in the diagnosis of rheumatoid arthritis and our markers identify approximately 70 percent of RA patients. Speaker 200:06:38This leaves roughly 30% of RA patients who would be seronegative with no current diagnostic biomarker commercially available. We plan to add new RA markers in the Q4 of this year, which we believe will allow us to improve the sensitivity of our rheumatoid arthritis assays and correctly identify 80% to 83% of total RA patients or up to a third of the traditional seronegative population. We believe this level of diagnostic performance is unmatched in alternative commercially available options and will continue to demonstrate to our clinicians our commitment to providing them the best quality testing with 1st in class performance. Altogether, these new markers substantially increase the utility of Advise CTD, which we believe will lead to increased product adoption. Our commercial team is preparing for the launch of these products. Speaker 200:07:32Our sales organization is eager to educate clinicians on the gain in clinical value. And our laboratory is working through the operational requirements to offer these novel markers at scale from launch. We expect the impact to CTD demand will likely be slow at first, marrying the pace of educational progress amongst our base of clinicians, but increasing over time. We're very excited to bring these innovations to patients, signifying the next phase of growth at Exigent. I'd also like to briefly touch on the FDA's proposed rule that became final a few weeks ago. Speaker 200:08:07We believe we are well situated to handle the additional regulatory requirements as our laboratory is CLIA, CAP and New York State certified and we perform several assays which are currently FDA approved. Broadly, we believe this regulation will create a barrier to entry for competitors in our market because it increases the resources required for commercialization of lab developed tests. We continue to monitor the development of these rules and do not currently anticipate any major impediments to executing our plan. Lastly, I'd like to thank Brian Burke, Doctor. Beto Poyedes and Wendy Johnson for their years of service, numerous contributions and guidance to XGen as they transition off our Board of Directors. Speaker 200:08:53Since I joined the company in late 2022, they have been integral in making the necessary changes to focus on achieving profitability and have been extremely supportive throughout my time here. Additionally, I'd like to welcome Doctor. Scott Kahn to our Board and look forward to leveraging his unique skill set and experience as we move to our next phase of growth. I'll now turn the call over to Kamal for details on our financial results. Speaker 300:09:20Thank you, John, and good morning, everyone. As John mentioned, it was a strong start to the year with total revenues in the Q1 of 2024 of 14,400,000 compared with $11,200,000 in the Q1 of 2023, a 28.4% increase. Total revenues were driven by record ASPs for Avaya CTD tests. Other testing revenue was 1,500,000 the Q1 of 2024 compared with $1,400,000 in the Q1 of 2023. Improvements to our revenue cycle continued to yield results as we collected approximately $700,000 from prior period collections from tests performed over a year ago. Speaker 300:10:03Cost of revenue were $5,800,000 in Q1 2024 resulting in total gross margin of 59.6 percent compared to 47.2 percent in Q1 2023. The increase in gross margin was driven by increases in ASP. Operating expenses excluding COGS for the Q1 of 2024 were $11,600,000 compared with $13,000,000 in Q1 2023. Year over year decreases were primarily due to a reduction in employee related expenses as a result of decreases in headcount. The net loss in Q1 2024 was 3,400,000 dollars compared with $7,700,000 in Q1 2023. Speaker 300:10:48Adjusted EBITDA was negative $2,000,000 for the Q1 of 2024 compared to negative $6,200,000 for the Q1 of 2023. As a reminder, our adjusted EBITDA excludes stock comp expense since it is a non cash expense for the organization. Please refer to our earnings release issued earlier today for a reconciliation of adjusted EBITDA to net loss. Looking to our balance sheet, cash and cash equivalents as of March 31, 1, 2024 were approximately $27,300,000 and our accounts receivable balance increased to $10,900,000 As we communicated in March, we fully anticipated the increase in AR and decrease in cash as we hold claims in the first half of the year as part of our revenue cycle management initiatives. This remains consistent with the strategy we employed last year and we anticipate this trend to continue in Q2 and begin to reverse in the second half of the year, similar to what we saw in 2023. Speaker 300:11:49I'm very happy with the start of the year as all key metrics continue to trend in the right direction. For full year 2024 revenue, we're raising guidance from approximately $54,000,000 to at least $55,000,000 We're also updating our adjusted EBITDA guide and now believe it will be better than negative $18,000,000 an improvement from our prior guidance of better than negative 20,000,000 dollars We reiterate our belief that our existing cash and cash equivalents are sufficient to meet our anticipated cash requirements into 2026. We will now open the call for questions. Operator00:12:26Thank you. We'll now be conducting a question and answer session. Thank you. And our first question today is from the line of Mark Massaro with BTIG. Please proceed with your questions. Speaker 400:13:01Hey guys, thank you for the questions and congrats on the quarter. The first one I think is on the new product launch with the T cell markers. I know you talked about it on the prior quarter call, but I'm sure you've had some time perhaps to think about how this might expand your market opportunity. I know certainly if you're able to diagnose earlier, perhaps could have increased clinical utility on some of the existing sets of customers that you're selling to. But can you just maybe expand a little more on the RA? Speaker 400:13:39Is this incremental to the size of the market and the patient type that you're going after? And can you perhaps help us think about how this can fit in and potentially expand your market opportunity? Speaker 200:13:55Hey, Mark. Good morning. Thanks so much for the question and opportunity to expand. Appreciate you joining the call as well. So when I joined the organization, we took a methodical approach to reviewing every aspect of our business and to specifically evaluate the opportunity in the market against the technology and projects we had ongoing internally. Speaker 200:14:17We start with the customer need and I truly believe that's important. It's a simple concept. It's out there in plain sight, but it can be hard to maintain this acorn point as you get into the thick of development. Certainly, I've had that experience. The science doesn't always work out as you draw it up, etcetera. Speaker 200:14:35But with both of these new marker efforts, we understand the customer need and we're building on the back of a proven, well adopted product in Advise CTD. We said consistently our market there is for ANA positive referrals into rheumatology. From a prevalence standpoint, that's roughly 41,000,000 Americans in the U. S. Up to a third of RA patients present with a positive ANA test. Speaker 200:15:01So this very much is in the wheelhouse of diagnostic utility within connective tissue disease. And our strategy across the organization has really been how do we make Advise CTD better. Whether that's with new markers such as these, whether we're improving our service with our sales and customer facing groups or even with our ASP efforts. We've gone all in and improving this part of our business and studying how Advise CTD is used clinically. And that's led us to want to strengthen that aspect, both in terms of what we can provide for diagnostic sensitivity of SLE and in rheumatoid arthritis. Speaker 200:15:41For RA, you have established markers used in the diagnosis of RA such as anti CCP antibodies, various rheumatoid factors. These are part of Advise CTD today. We also offer a fairly unique anti carbamylated protein or anti CARP as it's more commonly referred to, which helps improve the sensitivity in identifying suspected RA patients. But there's approximately 30% of RA patients, which are diagnosed without any serologic positivity. And this group of patients can be challenging clinically. Speaker 200:16:15This is exactly what these new markers aim to do. And as we said on the call, we anticipate capturing around a third of that what is today seronegative RA patient population and that should be industry setting performance. So very additive to Advise CTD. Speaker 400:16:34Got it. All right. Awesome. That's helpful. And then, obviously, you guys had a nice quarter. Speaker 400:16:40You exceeded My and Street expectations. Looks like a lot of this was driven by the ASP expansion. So for Kamal, look, I think I heard you say that you collected $700,000 from prior period collections. When I think about your raised guidance, are you expecting any other prior period collections for the rest of this year? And then even if you are not including it in guidance, how do you think about the potential opportunities to collect from prior periods? Speaker 400:17:12I know elsewhere in diagnostics land this quarter, I saw quite a few labs in my coverage that collected material amounts from prior periods. So how should we think about that opportunity set? Speaker 300:17:26Hi, Mark. Thanks for the question. Yes, we collected $700,000 in Q1 of 2020 4. Keep in mind, we had collected about $5,000,000 between Q2 2023 and Q4 2023. So we've seen that number come down in Q1. Speaker 300:17:46When we gave guidance last quarter, we made it clear that we don't factor in prior period collections into our guidance estimate and we didn't do that again this time. Just because of the visibility into collecting on prior period collections, it's very challenging to forecast that. And we did say over time, we expect that number to get closer to 0. So we weren't going to factor that into the guidance. Speaker 400:18:16Yes, that makes sense. And then maybe one more for you, Kamal. Do you still think that you can achieve cash flow breakeven at annual revenue of $75,000,000 60% gross margins? Speaker 300:18:31We had a great Q1 on gross margins, 59.6 percent. And over the last several years, you probably heard me say over and over again that usually you see the lowest gross margin in the Q1 because of seasonality, because deductibles resetting Q1. However, our strategy with revenue cycle management of holding claims has offset that seasonality impact on the gross margins and we didn't see that negative impact in Q1. So I was very pleased with that number of almost 60% on the gross margin. Now I used to say we build off that Q1 number. Speaker 300:19:09We're going to have a little bit of lumpiness with gross margins just because of that prior period collection number, but I'm very excited with how well we did at 59.6%. And when we do get to profitability, we always put that $75,000,000 revenue number and 60% gross margin figure as a goal. We've exceeded our internal expectations on the gross margin number. So as we get towards profitability, means our revenue number is going to come down slightly. Which means our revenue number is going to come down slightly. Speaker 400:19:43Yes, that makes sense. All right. Thanks so much guys. Operator00:19:48The next questions are from the line of Kyle Mixon with Canaccord Genuity. Please proceed with your questions. Speaker 500:19:55Hey guys, thanks for the questions. Congrats, really great quarter. Yes, just on that note, Kamal with the gross margin, if you take out the 700 ks prior period collections, it looks like the core gross margin was like high 50s, maybe 58%. I mean in the past, the core margin was like 50%. I think last quarter, if you take out the prior period collections, maybe 50% was the margin. Speaker 500:20:16So maybe just talk about what an organic gross margin looks like when you take out some of these prior period revenues? And just how to think about that going forward, what that means for the profitability kind of formula going forward? Speaker 300:20:30Sure. Thanks for the question, Kyle. Yes, so we still are exceeding what we have rejected internally in terms of gross margins even with the $700,000 taken out. So our ASPs have trended up considerably even without prior period collections. It's up almost $100 year over year. Speaker 300:20:53So we've been making great strides. It's obviously our gross margin isn't all being driven by that prior period collections. It's the ASP is the biggest contributor to the gross margin though, but not all from Speaker 600:21:08prior period. Speaker 500:21:09Yes. Okay. Thanks, Paul. And then John, on the, I guess, monthly volume levels, you said increased month over month, each month during 1Q, maybe like on an annualized basis, maybe March was ahead of 30 Speaker 600:21:24ks or so. I mean, Speaker 500:21:25can you just talk about maybe with some quantitative commentary like how we should think about the exit rates in March for volume and maybe we saw recently in April May? Speaker 200:21:36Hey, Kyle. Good morning. Thanks for joining the call. Appreciate the question. So we made changes just to give context why we're seeing some of these volume trends. Speaker 200:21:45We made changes to our process in 2023 in an effort to improve ASP for Advise CTD. And this is with a long run mentality or viewpoint. We're trying to operate a more profitable business and it's clearly working. There's more to come. And so this was absolutely the right approach to take and I'm very encouraged about our progress over the past 15 months. Speaker 200:22:09We did with these changes expect some temporary impact to volume as you said as we work with various accounts to adjust and as we focus our sales team on making these changes smooth. In the past and we're returning to this more traditionally now, our normal sales focus is in the pursuit of new business. And so that's occurring. We've moved more in that direction. I expected Q4 of 2023 to be the low point in terms of this temporary volume correction, and that's essentially exactly what we saw. Speaker 200:22:41It carried over a little bit to the 1st couple of weeks in January, but we had a strong end of January. February grew further. March was the height of the quarter. Our momentum has continued into Q2, and I'm very confident that we've returned to growth driven by a combination of ASP and volume improvements. We don't guide on volume per se, but this is exactly what we expected. Speaker 200:23:06To be honest, it's fun to be operating a more profitable business with a clear path to profitability and strong growth. And so we're very excited with the trajectory we're on. Speaker 500:23:17Okay, great. And quick side note, was did ASP remain pretty healthy in each month or did that decline sequentially? Speaker 300:23:27So with our ASP being on accrual methodology, we look at that monthly, but we don't make the final adjustments until the end of the quarter. So we'll be ready to comment on that at the next earnings call. There is nothing that we saw that would make me concerned with the ASP number going in a different direction than what you've seen over the past 4 quarters. Speaker 500:23:56Okay. That's good. Final one, John, just given this FDA final rule, I think you talked about that a little bit in your remarks. Just wondering impact to your pipeline. I know that it was kind of the emphasize in recent years a bit, but that I feel that remains an important part of the growth strategy long term. Speaker 500:24:11So maybe just talk a bit about how you're thinking about investing in the pipeline and kind of a future test and stuff including some of these new markers? Speaker 200:24:19Thanks, Carl. Very relevant question, really good question, something that we're evaluating and working to get smarter on, on a daily basis around here. To be clear, we're still studying the exact implications of the rule to best understand the potential strategic impacts it will have on our approach. I think there's a very real opportunity that this provides advantages for us and I want to better understand those. But then also I think maybe a little more to your question was around which gaps and what would it take to comply over the phase out period specifically relevant to our development efforts. Speaker 200:24:58So as it pertains to our development efforts or I guess not currently marketed would be the language used there, part of our pipeline. Like I said, we're still working through some clarifying points. The FDA itself is hosting a webinar tomorrow to clarify some of the details around the final rule. So even information out of the FDA is still, percolating. But we continue to be confident that our approach to developing LVTs and specifically our track record of meeting the requirements of New York State Certification will allow us to remain on track with our communicated timelines. Speaker 200:25:32So there will be some upgrades required we anticipate to our quality management systems, it appears. Again, that's likely over the next year or 2. But again, we're still working through all of these details over the coming months. We have the right resources to support our information gathering. And as we evaluate impacts to our strategic approach, we'll keep everyone apprised. Speaker 200:25:52We do believe that in the long run, final rule, this is likely to be a competitive advantage for us as it raises the bar in some respect to new entrants and LDT development. Speaker 500:26:05Perfect. That's helpful. Thanks, John. Thanks, guys. Speaker 700:26:08Thanks, Kyle. Operator00:26:10The next question is from the line of Dan Brennan with TD Cowen. Please proceed with your question. Speaker 700:26:16Great. Thanks for the questions. Congrats on the quarter. Maybe the first one on price. I think I heard you guys just mention that there's no reason the recent 4 quarter trend can't continue. Speaker 700:26:27So if we strip out the prior periods, it looks like price in Q3 went up $29 sequentially, Q4 up $40 and then this quarter up 40. So is the expectation that price will continue to climb from here? I know you're still withholding some claims, but did I hear you guys correctly on that? Speaker 200:26:46Good morning. So we are still holding claims. We do this for various internal reasons, which we think optimize our ability to collect cash relative to those claims. We've had tremendous growth on the ASP side. You just I appreciate you throwing out there those numbers. Speaker 200:27:06From our perspective, we're working hard on the processes that we know will pay off long term. We know how to do this strategically. We know how to operate very sound revenue cycle practices. And that's a big part of what I brought to the organization in coming here. It takes some time to get these things in place. Speaker 200:27:23We're very content and happy with how that progress has materialized, but we expect it to continue. Whether it will continue exactly in those proportions, ASP is an inherently difficult metric to forecast. That's part of the reason why we do the or point folks to the trailing 12 month metric. That's part of the reason why we don't provide guidance specifically related to ASP. We can have material wins at any given time in the future. Speaker 200:27:51The lower hanging fruit tends to be consumed, right, here in the early phases. And then it gets a little bit harder as time goes on. But we still are very optimistic internally that we have the right strategy in place to drive ASP higher over the long term. And again, looking at that trailing 12 month number is likely to give you a very good insight into the trend over time. Speaker 700:28:15Great. Thanks for that. And then maybe one just on volume. So just to be clear, it sounds like you're basically indicating that the volume growth that you've seen, you expect volumes to continue to climb sequentially from here. I mean, it might not be linearly, but is that the expectation that's kind of what you're thinking about for 2024? Speaker 200:28:31Yes, that's a very fair assumption. Speaker 700:28:35Got it. Okay. And then on the new markers, like could there be any impact on price over time? Would you look to refile and given you have greater utility that you might look to get a better price? And I know you sounded pretty excited you'll start to market these kind of this year and then into next. Speaker 700:28:51But could you also just help us think through I know you gave some color around the new market opportunity that you have, but just in terms of magnitude, like what kind of impact could these has as we look out in 2025 and 2026? Speaker 200:29:05That's a great question. At the surface, yes, we're extremely excited. We fully expect these new markers to be accretive to our individual, advised CTD pricing that are therefore top line certainly gets impacted. They'll be margin accretive as well. So these are very positive from a financial performance standpoint. Speaker 200:29:27And again, this is me super excited. So I'm trying to convey that from my standpoint. I think what the impact that these markers will have clinically, they're the most sensitive markers on the T cell side, they're the most sensitive markers for detection of SLE. On the rheumatoid arthritis side, This is sets the standard in the industry from our perspective. So to hit both of those milestones clinically, that's huge. Speaker 200:29:52And then to have it be a significant benefit for the organization we expect, I think this is a no brainer internally and something that we're we've got laser focused internally in getting these markers out as soon as possible sometime here in Q4. We're not ready to guide at any point right now on the financial impact. Really, especially since we don't have a solidified launch date and we're still working through the optimization in our lab, which could change some of the COG profile, etcetera. So but you're exactly right, 25, 26, this will be very substantial for the organization. Speaker 700:30:32Great. Okay. Thanks, guys. Operator00:30:36Our next questions are from the line of Andrew Brackmann with William Blair. Please proceed with your questions. Speaker 600:30:42Hi, good morning. This is Dustin on for Andrew. Thanks for taking our First question on the guide. Just wondering what your spending priorities are for the year given adjusted EBITDA came in better than expected minus $2,000,000 but the full year guide is at minus 8 or better than minus $18,000,000 for the year? Thank you. Speaker 200:31:04Hey, Dustin, good morning. Thanks for joining. Appreciate that. If you take a look at R and D, and Kamal can comment a little bit on OpEx and SG Speaker 500:31:13and A and Speaker 200:31:13stuff. But if you take a look at R and D in Q1, we still spent $1,000,000 That's consistent with what we said historically, annual expenditures approaching kind of that $5,000,000 $6,000,000 range. That's sufficient to bring the new markers to market, T cells along with RA. Those costs have already been baked in. They're included in that number. Speaker 200:31:35And then we also have a few other projects in our pipeline around disease activity in SLE along with continuing to push along some of the technology that we licensed out of Johns Hopkins. So we're not rolling back the development that we need for future growth. Organizationally, we're still spending to keep our instrumentation in the lab very relevant, very up to date. From a guidance standpoint, how that factors into the negative 18%, we're extremely proud maybe one thing to start off with. We're extremely proud of the progress here in Q1 and our ability to deliver strong revenue growth and I guess ever contracting adjusted EBITDA loss. Speaker 200:32:23But just over a year ago, we were averaging about $10,000,000 negative $10,000,000 per quarter in adjusted EBITDA. Last year, we cut that in half to a negative $5,000,000 per quarter on average. So from our perspective, the recent trends have to be kept in context, we believe, especially since we had approximately $5,000,000 in prior period collections aiding our numbers last year. So while we have continued to outpace even our internal projections, our progress will bounce around a little bit and we're not quite ready to establish a new run rate in terms of adjusted EBITDA. But we do feel very confident that we will achieve our goals and we're working to do so ahead of expectations is maybe how I mentioned that. Speaker 200:33:04And Doug, I'll just add. We've been very prudent with our expense control on our pathway to Speaker 300:33:09profitability. When looking at SG and A and R and D, I would just factor in small expense increases quarter over quarter mainly due to inflationary increases. Speaker 600:33:24Okay, makes sense. Thanks for that. And then maybe wondering if you can talk a little bit about sales force productivity. You made some changes to the organization over the last year. So is there any color you can add on how we should be thinking about driving further productivity from here? Speaker 200:33:43It's a great question. So just to give a sense of our current sales footprint across the U. S, when I joined the organization in late 2022, we had 63 territories. We did an evaluation to take a look at how we would breakeven across the various territories and at least cover the cost of the sales rep. We consolidated those 63 down to 40 in December of 2022, and we've been operating at that level since. Speaker 200:34:09We've really been working to coach and drive 2023. So we feel that 40 is the right number for us right now. We're still working through some of the adjustments that we made in July regarding our billing policy. And so as I've mentioned, our team is heavily focused on ensuring that each individual account is serviced well and that these transitions are smooth. As we return more to, I guess, hunting mindset, pursuit of new business mindset, more traditional approach from the sales standpoint, we've got the right footprint for some time here and certainly have the ability to grow with this existing footprint. Speaker 200:34:59As we move into higher levels of profitability within each territory, then we'll expand kind of empirically from there. Speaker 600:35:12Okay. One last one for us. Just what assumptions are you guys making either strategically or financially for the increased education for the new markers you're planning on adding later this year? Thank you. Speaker 200:35:26That's a good question as well. From our standpoint, we just we believe our current expense profile is sufficient to launch these new markers. There may be some additional conferences we attend. There may be some small advertisements that we do on relevant to the rheumatology community. But from our standpoint, there's not a huge need to have an outsized expenditure related to the launch of these products. Speaker 200:35:56We're preparing a manuscript. We think the science is really where you need to start in the messaging. Our sales team knows our current product extremely well. So layering on additional clinical utility evidence is just part of the evolution of the knowledge of our product. So from our standpoint, I wouldn't expect SG and A to change much. Speaker 600:36:22Okay. That's it from us. Thank you. Operator00:36:27Thank you. At this time, we've reached the end of the question and answer session. Now I'll turn the call over to John Abali for closing remarks. Speaker 200:36:34Thanks. We're off to an excellent start to the year. My confidence and optimism continue to build as our organization evolves and undergoes substantial improvements. We've set ourselves up for sustainable growth throughout the changes we made last year and with the updates planned for Advise CTD this year. Will continue to accelerate that growth. Speaker 200:36:54It's encouraging to see the devotion within the ExoGen team and I truthfully could not be more excited for our future. Thanks so much for joining the call today. Operator00:37:04This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.Read morePowered by