Greetings, and welcome to Exagen Inc. Fourth Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ryan Douglas, Investor Relations. Thank you. You may begin.

Good morning, and thank you for joining us. Earlier today, Exagen Inc. Released financial results for the quarter and year ended December 31, 2024. John Aballi, our President and Chief Executive Officer; and Jeff Black, our Chief Financial Officer, will host this morning's call. A recording of today's call and the press release announcing our results can be found on the company's website at www.exagen.com. As today's call includes forward-looking statements, we encourage you to review the statements contained in today's press release and the risks and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance and results to differ materially from those contained in the forward-looking statements made on today's call. In addition, we will discuss non GAAP financial measures on this call. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP measures are included in today's press release. I'll now turn the call over to John.

Good morning, and thanks to everyone for being on the call today. I'll start off by recapping our results from 2024, give some color from the launch of our new markers and comment on our outlook for 2025. Jeff will provide additional detail on the financials later in the call. 2024 was a great year at Exagen. We made major strides in continuing to build the leadership team needed to elevate our organization to the next wave of growth. And we've made significant progress in executing on our strategy towards profitability. From a top line perspective, we delivered another year of record total revenue, growing to $55.6 million driven largely by continued improvement in reimbursement. With this progress, our adjusted EBITDA loss narrowed to approximately $10 million showcasing our focus in prudently operating our business. Our trailing 12-month average selling price increased to $411 for AVISE CTD, a gain of $75 per test over 2023. As a result of our ASP gains and continued excellent operational management gross margins expanded just over 300 basis points in 2024 compared to the year prior, coming in close to the 60% mark for the full year. Perhaps most importantly, we developed and commercialized new biomarkers for the first major enhancements to AVISE CTD since the product's inception. We also finished the year with an incredible achievement, testing our 1 millionth patient by AVISE CTD and are extremely proud of the many milestones our organization reached in 2024. To dive deeper into the launch of our new biomarkers this past January, I'm very proud of the hard work and preparation exhibited by our operational and commercial teams. These efforts have resulted in a successful launch to the rheumatology community. The markers have been well received by our ordering physicians and we are encouraged by…

Thank you, John, and good morning, everybody. As John mentioned, 2024 was a great year for the organization on several fronts. The team did a great job of executing and exceeding our goals for the year. We've set records for several of our financial metrics and have a clear line of sight to expand on those in 2025. Diving into details, starting with revenue, our full year revenue reached a record $55.6 million marking a 6% increase from 2023. And this full year year-over-year increase in revenue was due primarily to expansion at ASP, consistent with our strategy of driving profitable revenue. As John mentioned, our trailing 12 month ASP for 2024 was $411 up $75 in 2024 and up $126 since 2022, when John initiated a strategy to focus on reimbursement. We've continued to prioritize improvements in our AVISE CTD average selling price through optimizing revenue cycle management with much success, but sometimes at the expense of volume growth, which was intentional. As a result, we saw an expected decline in volume due to attrition from doctors who are unable to support the necessary partnership, including additional documentation often required for acceptable reimbursement levels. We also over the same two year period made the strategic decision to reduce our commercial footprint from over 60 sales territories at the end of 2022 to roughly 40 at the end of 2024, eliminating several unprofitable sales channels. This too resulted in an expected decline in volume. Moving forward, we continue to prioritize ASP expansion, but expect to see a return to volume growth attributed to increased adoption from the enhanced utility provided by our AVISE CTD biomarkers and the addition of commercial territories with a focus on growing profitably. While we don't believe 6% revenue growth represents the long term trajectory of…

[Operator Instructions] Today's first question is coming from Kyle Mikson of Canaccord Genuity.

Hey, guys. Thanks for the questions. Congrats on the year. Could you, I know, John, you were talking about like you can't really quantify the impact from the new markers just yet. But is there, just any way to help us think about maybe the modeling for ASP going forward based on these new markers, how that could trend this year? And then I think importantly, like the gross margin impact too from those from this like $90 incremental revenue you're talking about too. If you could just tell all those factors, it would be great.

Hey, Kyle. Good morning. Appreciate the question. Thanks for the chance to expand. So as it relates to the trend for the new marker reimbursement, the $90 specifically, the reason we're unable to exactly give the clarity for full 2025 right now is because we've been efficient and effective in our appeals process over time and it just takes a little bit of time for that to bear out. So the $90 right now is based on current cash collections plus some assumption for efficacy in our appeals process or revenue cycle process. And I think it's a pretty good approximation for right now. So where that could trend, I think similarly to what you're seeing with our broader businesses, we're effective and efficient in our ability to drive ASP gains. So it could likely trend up, It's not going to reach the $200 mark. I think that's unreasonable. So it's not going to double, but it could creep up from there. We'll know more in our Q1 call. So maybe a month and a half, two months from now, as more of the appeal efforts come in. But it's a more straightforward billing process. And so I think it's a pretty reasonable approximation. As it relates to gross margin, your question was more broadly what's the base business trending over time. Is that right, Kyle?

Yeah. And I think the impact from the markers would be good to know as well, given that's an ASP lift. So that you would think that the margin is better work if the same, if not better, so it could help come to gross margin, yes.

Got it. So we believe now with the addition of these new markers, the mid-60s is not an unreasonable expectation for margins over time. And so we'll have to see. I don't anticipate guiding necessarily on margins, but that mid-60 level is within reach.

Awesome. And then Jeff, maybe one for you on the adjusted EBITDA profitability target for 4Q, that's great to see. Do you also have like an operating cash flow positive or breakeven target as well for 4Q? And maybe you could talk about that as well as the accounts receivable movement you expect throughout the year as well?

Kyle, great. Thanks for the question. Yes, I think as you think about on a full year basis in our business, adjusted EBITDA is a good proxy for free cash flow and we spent a full year basis. The nuance being that the quarter to quarter working capital impact of holding claims particularly in the first quarter will increase cash requirements early in any year. But over the course of the year on a blended basis, I think thinking about adjusted EBITDA and free cash flow as a proxy for one another is the right way to think about it.

Great. And last one for you John on actually the kind of want to ask your update on kind of your thoughts of or test data to biopharma companies. Like there's been a lot of news flow even in the past few weeks kind of regarding SLE drugs and so forth. Is there an opportunity there for you as a partner to pharma given your industry leading position?

We believe there is. Our efforts on the biopharma side were really early when I joined the organization. I think we necessarily the business model was more capitalizing on inbound inquiries as opposed to having a selling process and activating partners that had some strategic impact and where we thought we could provide a unique service or solution. That has shifted since I've been on board. And as I detailed in ‘24, we're pretty excited about some of the contract changes we've seen along with the magnitude of some of those contracts. The revenue from that comes in over a couple of year period. We should start to see more of that here in 2025 and very positive from our standpoint. There's some exciting development. We do think that there's a tailwind in terms of the market growth there, spending on the autoimmune side from a biopharma standpoint is projected to increase over time. So it's a healthy area for investment. We're looking to capitalize on it and we do have unique proprietary offerings. We have a group of right now about four individuals that this is really the area they focus on. So more to come throughout the year. I think you'll start to see some of the efforts we're putting in place and it'll be exciting to give you guys some updates. But it's definitely a positive area for us.

The next question is coming from Ross Osborn of Cantor Fitzgerald.

Hi, good morning and congrats on the progress. Starting off, would you remind us on where the January launch of RA33 will get you in terms of sensitivity and if there are any incremental improvements we should be thinking about this year?

Yeah. Hey, Ross. Good morning. Thanks for the opportunity to talk clinically. So, our January launch encompassed a set of two additional aspects to our test. The first being the launch of novel T cell biomarkers, which specifically improves the sensitivity for lupus diagnosis. And we just actually published our manuscript in Frontiers in Immunology, pretty exciting publication, very strong KOL support. And what that manuscript showed was for the lupus patients that were serologically negative, so their diagnosis was based solely on clinical aspects alone. The novel T cell markers, the three of which we launch were positive in roughly 51% of those patients. So the way to think about this is obviously cohort to cohort, you have different variables and whatnot. But a good way to think about this is we captured roughly half of the lupus patients that were not captured by conventional markers or our traditional AVISE testing. So ultimately that boosts sensitivity in our mind closer to about we're capturing 9 out of 10 lupus patients through our entire AVISE test, which is an exciting development for us. On the rheumatoid arthritis side, what we launched there were the first set of some novel biomarkers improving the sensitivity for diagnosis, specifically within the traditionally seronegative population. And from a rheumatoid arthritis standpoint, there's some fantastic biomarkers that exist, rheumatoid factor, ACMA antibodies, but about 30% of patients have no serological abnormalities. So their diagnosis is purely clinical, very similar to what I just described on the lupus side. In that context, this first set of markers captures about 15%, 16% of those patients and we have a second set of markers coming later this year, hopefully by the end of the year that will boost that overall to about 30%, 40%. So in general, we believe that within the next, call it 12 months or so, we should be able to capture almost half of the seronegative population and that by far outpaces, any other diagnostic that is commercially available. So very excited about both of those aspects.

Great. Glad to hear it. And then where does manufacturing stand in terms of capacity and how do you feel about your ability to meet demand this year?

That's a great question. So we invested heavily from a capacity standpoint towards the end of the year in any capital equipment we needed. Our more complex technology is flow cytometry. We did entire upgrade of our suite of instruments in the back half of ‘24. That was about a $1.2 million investment. That's all been made. We have significant investment in robotics that we've made over the last six months and we'll continue to do so here into 2025. Personnel wise, we've staffed up for the increased volume that we expect and have started to see here in ‘25. So current capacity is adequate for the launch. We expect to scale with labor basically. And capital wise, we feel like we're in a pretty good shape at least for ‘25 and into ‘26. Our facilities have the capacity, significant more capacity than the current testing volume. And what I mean by that is, we operate mostly primarily a day shift, starts about four in the morning, goes to about eight at night. That's the day shift for us. And but can also go into the evening. And so we could have a night shift if need be to preserve the viability and to increase our capacity and it wouldn't require a change from a capital standpoint or facility standpoint. So, have some buffer there.

Thanks for taking our questions and congrats again on the progress.

The next question is coming from Mark Massaro of BTIG.

Hey, guys. Thank you for taking the questions. John, the first one's for you. I thought the case study you provided in the prepared remarks was pretty interesting, in that the patient's diagnosis was changed from fibromyalgia to rheumatoid arthritis. With that case study, and it sounds like you had a few others come in that were similar, are you now thinking that, potentially the AVISE product might have a larger total addressable market to rule in RA versus lupus or how should we think about the market size for the core product?

Yeah. Good morning, Mark. It is a pretty interesting case study because it came to us unsolicited by the way. That clinician was super excited about their firsthand experience and it's always nice to get that feedback. We've had it happen in a few other places. And I was actually in the field last week talking to a group of physicians. And it's very clear that they're enamored and interested in the about these new markers and see the applicability to their clinical practice. So exciting when you actually get to see it firsthand in that sense. As it relates to your question, what do we think the market opportunity is and how has it shifted with the launch of these new markers. I do believe, I mean, I think it's pretty rational thought here that as you enhance your value proposition on the RA side, the utility for clinicians in that context increases. And that's what we believe currently and I believe it's actually starting to pan out as we think. So from our standpoint, rheumatoid arthritis prevalence is depending on your sources somewhere around eight times that of systemic lupus. So a dramatically different size market. We do believe that the differential broadens the utility of the differential diagnosis broadens when we added these additional RA markers and we'll continue to do so throughout the year as we add additional waves to this. So we're seeing it firsthand with case studies. We're seeing it in some of the ordering. And that's a part of what's factoring into our sales expansion later this year as well. For each territory, the potential basically has shifted in our minds. And so dramatically different market.

Okay. That's great. And then just to clarify, so obviously a $90 per test in incremental revenue is a big leap. And so I just want to clarify you came in at $411 for ASPs at Q4 and year end. Just making sure I'm hearing that the -- you're feeling pretty good about getting the ASP per test to approximately $500 per test at Q1. And then just to clarify, do you think the $500 per test in Q1, if that's true, can serve as a potential launching point for the rest of the year?

Very important point, Mark. Thanks for the chance to expand. So a couple of factors here. One, we launched the test partway into the quarter. So if you assume an average $500 per test, I think you're going to overestimate for Q1 just given the sense that we launched call it the January for the new markers. Additionally, and I just want folks to have clarity here, the trailing 12 month number will go up by roughly a little less than a quarter of that $90, we would anticipate over the coming quarters. And that's just because it's a trailing 12 month number, right? It incorporates data from the last four quarters. And so you're diluting out that $90 if you've only been a quarter in, for example. So just so that folks understand as we report out future numbers, some context there. But basically, Mark, your math is pretty good, if you can take those two factors into account. And we believe that the incremental ad is real $90. One other point that Jeff just made important to consider. We do have prior period collections in any given quarter. And so the fluctuation that $411 includes I think about $2.8 million in collections greater than 12 months from prior to '24, for example. So that's just something that we've said in the past, very difficult to forecast and can be lumpy. So just those three considerations.

Yeah. Mark, just to put a finer point on that, just so people understand. Clearly the company and with John coming in and implementing this revenue cycle reimbursement strategy to expand ASP has met with great success. But we continue to raise the bar on ourselves because as we enhance prior period collections it increases our organic ASP and therefore our accrual rate. So some of that prior period collection now going forward is already baked into the average ASP. So there could be a bit of a tailwind on the average 12 months just because we're continuing to raise the bar in ourselves with the prior collections. Does that make sense?

Yes. It does. Thanks guys for clarifying that. That makes perfect sense. One last question. You guys talked about in 2024, you saw some decline in volume due to attrition from docs, who were unable to support or provide additional documentation required to obtain reimbursement. I'm wondering if you think that, you could go back to those physicians and walk them through the documentation needed. Because I'm wondering if you think that business could come back or not. And then is there any way that you could frame what -- how much of the volume you think, occurred because of that?

Yeah. Great question. So maybe some additional information that could be useful, Mark. If you take a look at the average number of unique ordering providers per quarter. In 2024, it was just under 2,500. So 2,500 unique ordering physicians ordered the AVISE CTD platform per quarter on average in 2024, excuse me in ‘23. In ‘24, it's about 2,400. So we lost about 4.5% of our ordering base year-over-year. Keep in mind that if you take a look at the expense profile of that, we've gone from an SG&A standpoint, really reduced our overall SG&A by about $11 million to $12 million during that period as well. So from our standpoint, we're operating more efficiently. We've cut back the sales team by a third when I joined. We're on the cusp of expanding. And if you told me at the start that you'd lose roughly about 4.5% of the physician base, but still be able to grow your top-line. I would take that. That was really the intention of what we were trying to do. I do think that that business is recoverable to your point. We need to optimize our processes, so that prior -- becomes easier requesting medical records becomes less frictional. It's just a smooth interaction in that sense. But I knew that if we continued on the path we were on, we absolutely were not going to get paid. And so there is a trade-off there that has to occur. Our value proposition continues to strengthen with these new markers. And going back to those docs, they've already bought into these that advise at some point in their clinical practice. And so this is really just smoothing out those interactions over time. That's where we've been heavily focused. So we'll continue to do that. But these new markers provide the perfect opportunity to go back.

The next question is coming from Dan Brennan of TD Cowen.

Great. Thank you. Thanks for the questions. Congrats on the quarter. Maybe just starting on pricing, can you just remind us in terms of your initial feedback from commercial payers, I think your -- I think the last -- I think you said what may be less than 50% of commercial payers, either you're getting paid out or in contract. Just give us a sense with the new markers and that $90 lift, how that's kind of flowing through between your different payer groups?

Yes. Good morning, Dan. Thanks for the question. From individual payer perspective, we think about it oftentimes in terms of financial categories. So we lump the blues together, for example, we have some of the large national payers together, government, et cetera. We're seeing very consistent performance as we have with some of our other traditional testing. Obviously with these new markers, we're facing much lower rate of denial for experimental investigational reasons for example. So there's not a lot of question as to the utility of these markers within this disease context. What we are typically getting denied for, if you will, or where patient responsibility seems to be outsized is around in network status for the most part. And so that's consistent with, again, some of our therapeutic monitoring testing that we offer and some of the financial modeling we did ahead of time. But relative to AVISE CTD, lower rate of overall denials from a coverage standpoint, just your more typical out of network type denials, which is not a problem for us. If you think about it, out of network really is applicable when you offer something that someone else can do as well. And in both of these settings, we're sole source provider. So that's the basis for an effective appeal is that you can't get these markers anywhere else. Again, we'll know over time how effective we are in shifting some of the responsibility back from the patient to the payer, basically being treated as in network status given the uniqueness of the markers, but that will take a little bit of time and that will hone our precision on the $90 we gave.

Okay. That sounds good. And then on the RA opportunity, just remind us when you've sized or you think about the opportunity for the test now really to penetrate RA. Just what's kind of how big is that opportunity? How do we think about just even framing that over the next kind of year or two?

Yes. So AVISE CTD is useful when you have a suspected connective tissue disease. And that number is not in the literature anywhere that we can find. So we triangulated our internal calculations, taking a look at incidence for each of these diseases along with the positivity rates we have on our AVISE test. And what we've been able to conclude is, now with more confidence that the RA market is truly an opportunity for us with the unique offering that the annual rate of connective tissue disease evaluations is somewhere around $2.5 million. So that would put us on a conservative side around 5% penetrated. If you want to create a range here with confidence intervals and whatnot, you can get up to maybe about 10% penetrated. So we just think the value proposition has been enhanced. We always had markers for traditional rheumatoid arthritis evaluation, but now there's a unique reason and opportunity for us to help patients and clinicians in this in this area. So that's really what we're going after. Somewhere around 2.5 million tests a year is what our current estimate is.

And then maybe if I can just go on the volume side. You talked about really focusing on profitability and all the success you've had with the burn and the pricing. But you also talked in the prepared remarks you were disappointed with kind of the volume. So for '25, are how do we think about, like, kind of the guardrails, if you will, on your willingness or aggressiveness in going after new doctors, new patients in terms of also balancing in against getting paid. So I guess we'll get the update on the volume outlook at Q1. But I'm just wondering, should we expect kind of the number of ordering docs to go up? Like, just can you speak through the methodology at which, like, you're seeking to grow volumes?

Absolutely, Dan. So my comments a second ago are really just rooted in the fact that I think it's important to be transparent and honest in performance and objective as much as you can be. And we have high expectations for ourselves in in really every area. So, we always think that we can do better. I think, objectively, if you were to look at our performance over the last two years, that would be the one area that you could point to and say, I would like to see this improve. And that's exactly our mindset internally. We've dramatically enhanced the quality of our team over the last year. We've changed our sales leadership and happy to have someone that I've worked with at prior organizations join. We've had a shift in the leadership underneath that person and the various reps throughout our territories are of very high caliber. Now over the last 12, 18 months, we've made some changes there. So we have the right team in place. In terms of the trajectory from a volume growth standpoint, we expect it to improve. If you take a look at when we made these billing changes in the back half of ’23, we've been, moderately up from where we were at the back half of ’23 that run rate. And I expect us to maybe approach the high-single digits from a volume growth standpoint that's based on legacy growth rates. I do expect the volume of physicians to increase. We're doing our first sales expansion since I've been here. This year, we're at a handful of territories. So by all salient sales metrics, I would expect increases over the course of 2025. So number of physicians, orders per physician, and overall volume.

And maybe just one for Jeff. Just on OpEx leverage, can you just remind us how implied in the guide you talked a little bit about gross margins, kind of how do we think about OpEx leverage for the year?

Sure. Yeah. Dan, appreciate the question. So the way to think about this is that, yeah, we will make some moderate incremental investments, particularly on commercial and continue to invest in the R&D pipeline. But think about the level of revenue growth will outpace the level of OpEx growth. So we really will start to see some scale throughout 2025. And we'll see that in the margin as well. I think in terms of expectation, you really start to see that scale in the second half of the year because we've invested it ahead of the curve, particularly in laboratory operations to accommodate the expected increase in demand. So I think you start to really see that leverage in the last half of the year.

The next question is coming from Andrew Brackmann of William Blair.

Hi, guys. Good morning. Thanks for taking the question. Maybe back to the example that you gave from Florida, it seems like this was sort of a moment for that particular physician. So I guess on average, do you sort of have an estimate for how many tests of this new version might need to be ordered to get to that point where they see that benefit and it potentially drives more volume? And I guess related to that, any commercial strategies that you can deploy to maybe get them there a little bit faster?

Hey, Andrew. Thanks for the question. I think it's a fantastic one and one we're evaluating internally. Although we probably tested more people with these new biomarkers than had been done previously, I mean in a given month, we're doing 10,000 of these tests plus. So now a month and a half two months in we've tested close, in the several thousand patient range. Still a little early to recognize the overall positivity rate, which is I think what you're asking. And, it's a good suggestion for our next earnings call to give some of that color, so I'll plan to do so. But, fantastic question. I think it also has to do a little bit with how are physicians using the test and what's their pretest probability that the patient has RA? So it may be a little bit different on a physician to physician basis, but we'll have that for you in the future. From the standpoint of how to accelerate this individual experience for the broader physician population? We're turning it into a case study. And this is actually at the recommendation of the physician themselves. So using similar to how I described on the call, using a de-identified example, but with enough specifics to show that it is true and real. And then to provide this in a few different contexts would, I think be very useful. It'd also be nice to have some level of outcome data, which will take some time. But those are things definitely we're looking at doing and partnering with clinicians as they use these novel markers. That's a great suggestion.

Okay. I'll be sure to ask it on the next quarter call as well. I guess maybe also here just on the pipeline, any catalyst that we should be sort of thinking about for 2025? And then can you just maybe just give us a refresher on where that stands today?

Yeah. So the major catalyst obviously was launched here in January with these new suite of markers. I think that that's very key. We also expect to have sales expansion from a territory standpoint, maybe approaching the low-40s into the mid-40s. We're currently at 40 right now. So up to 10% growth in our territory volume. Those people take some time to get up to speed, but we do anticipate them contributing here in '25. Our pharma business is going strong. It's been going strong here over the last, call it 12 months and we expect that to continue this year. And we also have a second wave of RA markers that we anticipate launching by year end maybe early ’26 that should further enhance that value proposition. So I would think that those efforts are going to be the major catalyst that will be most apparent in the operations of our business. I'll leave it at that.

Okay, great. I'll leave it at too. Thanks, guys.

The next question is coming from Matthew Parisi of KeyBanc.

Hi. Yes. This is Matt Parisi on for Paul Knight. I was just wondering if you could provide a little bit more detail on the testing volume in general. If you maybe could give a number of that?

Yeah. Hey, Matthew. Good morning. And I'm assuming you're referring to 2024 testing volume?

Yes. As opposed to.

No. Not a problem. So, total test volume for 2024 was 123,000 AVISE CTD units. That's down 11% relative to 2023. Keep in mind that the first half of 2023 was record volume for the organization in both quarters. So as I said, comparing to the run-rate post billing changes, you're up slightly to moderately since those billing changes. Does that answer your question?

Yes, perfectly. Thanks so much.

Thank you. At this point, I would like to turn the floor back over to Mr. Aballi for closing comments.

Great. Thanks all. As we wrap-up discussion of our performance for 2024, our team remains highly motivated and committed to positioning our company for long term success. We are on track to achieve key milestones that will create value and with this momentum, we're well-positioned for an exciting year ahead. We appreciated your continued partnership and look forward to providing future updates. Thanks.

Ladies and gentlemen, this concludes today's event. You may disconnect your lines or log up the webcast at this time, and enjoy the rest of your day.