Greetings. Welcome to the Exagen Inc. Third Quarter 2024 Earnings 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 to your host Ryan Douglas, Investor Relations. Please go ahead.

Good morning, and thank you for joining us. Earlier today, Exagen Inc. released financial results for the quarter ended September 30, 2024. John Aballi, President and Chief Executive Officer and Jeffrey Black, Chief Financial Officer will host this morning's call. A recording of today’s call and the press release announcing the quarterly 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 filing, 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 financial measures are included in today's press release. I'll now turn the call over to John Aballi, President and CEO of Exagen.

Good morning and thanks to everyone for joining the call today. We had an exciting quarter at Exigent where we've continued to make substantial progress in executing our strategic plan. Today, I'll provide detail relating to our near-term goals and cover a few financial highlights for the quarter. But first, I want to officially welcome Jeff Black to the team as our new Chief Financial Officer. Jeff joined us on September 1 and has done a fantastic job jumping in and adding value and has quickly become a key member of the team. Welcome again, Jeff. Our performance in the third quarter came in line with our expectations as we continue to execute our strategic plan of delivering profitable growth. We have set ourselves up well to achieve overall cash flow positivity, which we now believe will occur by the end of next year. Our total revenue for the third quarter was $12.5 million which includes the net negative impact of $1.2 third quarter in onetime adjustments. These adjustments slightly change our outlook for the year, but I continue to be very excited about the long-term potential of our business and the near-term inflection we anticipate. Jeff will provide additional detail on our financial performance and the onetime adjustments later in the call. In looking at the AVISE business, testing volume was in line with internal expectations, down slightly quarter-over-quarter due to seasonal factors, including an uptick in out-of-office time for physicians and weather-related events towards the end of the quarter impacting our Southeast territories. Our trailing 12-month AVISE ASP improved for the 7th consecutive quarter, up to $404 per CTD test and inclusive of the net negative onetime adjustments further demonstrating the strength of our efforts in growing ASP. Our adjusted EBITDA loss was approximately $4 million for the…

Thank you, John, and good morning, everybody. I'll get into the results in just a minute, but wanted to start off by saying thank you to the Exagen team for their warm welcome. I already know several of Exagen's partners in the investor community and I'm looking forward to bringing my experience and working with all of you as we continue to expand on the solid foundation John and team have built. The strategy John put into place two years ago has exceeded probably even his expectations in terms of how quickly the results have materialized. As we close in on bringing the business to profitability, I look forward to working with John on the next phase of growth and building Exagen for long term success and shareholder value. Starting with revenue, as John mentioned, third quarter revenue was $12.5 million down 7% compared to the third quarter of 2023. This decrease was primarily due to onetime adjustments recognized in the third quarter which I will expand on shortly. Excluding these adjustments, revenue in the quarter was $13.7 million up about 2% over 2023 and year-to-date revenue was $42 million up 8% over 2023. This increase in 2024 was driven primarily by our ASP expansion. Now some more color around the adjustments. Our $12.5 million in total revenue for the third quarter of 2024 included $1.2 million in onetime adjustments. Breaking this down, first, we identified and self-corrected a CPT coding discrepancy related to our AVISE Vasculitis test dating back to the product's inception in 2020 and this resulted in an approximate $300,000 reversal of revenue in the third quarter. In addition, one of the first things I undertook when I joined was a full review of our accrual rates and accounts receivable with my team. As a standard practice,…

Thank you. [Operator Instructions]. The first question comes from the line of Mark Massaro from BTIG. Please go ahead.

Hey guys, thank you for taking the questions. And Jeff, nice to work with you again. Maybe the first one, will go to Jeff. Maybe just walk me through the one timer just a little bit more just to make sure that, I heard you say that the matter is not systematic. It sounds like you did a review of all of your AR of your reserves. Just checking to gauge your confidence that you don't think this is likely to happen again perhaps? And then I also wanted to ask what the impact was due to the storms in Q3?

Sure. Mark, great to reconnect with you again. Great to be on board. Sure. I'll take the adjustment question. I can let John comment on some of the seasonality impacts. So I think thinking about the $1.2 million in adjustments really breaks down as I said in two pieces. I think the more simplistic one is we did have an historical coding discrepancy on our AVISE Vasculitis test that we self-reported or self-discovered and adjusted for that resulted in about a $300,000 reversal of revenue. And that was just given the difference between the CPT coding reimbursement rate. So that's well behind us. It was a onetime thing reflected coding discrepancy since the inception of the test. The $900,000 is exactly what you said, Mark, in terms of just really taking a very deep dive into our AR balances and identifying what we talk about really is more one time risk related to the carrying value of certain AR balances. Really, it's a cumulative effect that justified a write down in the third quarter. I think importantly, no material changes to payer rates. So we're not seeing this have an impact on ASP. This is really more about carrying value of AR that we adjusted for. In fact, as John said, we continue to see an expansion in our ASP. So to us, this was one time. It was addressing some identified risk in AR balance, but you really had no impact on our expected or overall payer rates.

Okay, great. And then one for you John, it sounds like you are making good progress on the new biomarker launch. You talked about hoping to get an ASP increase. I know you talked about that in the prior quarter, but maybe can you just shed a little bit of light about how much of an impact you think might benefit the company in 2025?

Hey, Mark, certainly. Good morning and thanks for the opportunity to expand here. Also hit on the storm question you referenced a second ago as well. So first and foremost, we are excited and on track to launch our new marker enhancements by the end of the year. We've completed our analytical validations internally and submitted those to New York State. So really everything that we can control, we've done. And now we're waiting for the regulatory approval under the new FDA rules. So very exciting time for us and we expect that here again by year end, but this is our first time going through it post FDA rules. The impact to the business, we anticipate to be substantial. My approach here on this in terms of quantifying specifically ASP or volume impact is a little bit of a wait and see approach. We have a good model internally, but until cash hits the bank, I'm hesitant to throw out a number. I just want to have a higher degree of certainty, from our standpoint. I think the color I can provide is that these are established CPT codes. So it'll be part of our CPT code stack as opposed to a proprietary code. So we don't anticipate huge hurdles on the coverage standpoint. Pricing is on the CLFS. There are established methodologies within our lab, both flow cytometry as well as ELISA based assays. And so from that standpoint, we do anticipate the impact to be sizable. And now given that we've already submitted to New York State, foresee ourselves being cash flow positive organization by the end of 2025. So, huge impact for us organizationally. As it relates -- so happy to follow-up with other questions there, Mark, but as it relates to the hurricane, at the…

Great. That's helpful. I will hop back in the queue.

Thank you. The next question is from the line of Daniel Brennan from TD Cowen. Please go ahead.

Great. Thank you. Thanks for taking the questions. It's Jeff. Nice to be working with you again as well. Maybe just one more on the $1.2 million I know like the last I think five or six quarters you've had on average call it $1.5 million of positive development. This quarter I don't think you reported any. So does the $1.2 million and the scrutiny now on the AR balances and you've cleaned that up, does that mean that no more prior period positive developments going forward, just trying to reconcile both of those?

Yes, Dan, it's a great question. Again, great to be working to you again. It's a great question. I think we can separate those two in terms of the $1.2 million was a very specific set of adjustments that really had nothing to do with prior period collections. But you do raise a great point and that is we are seeing as expected our prior period collections start to taper, right? And I think that's all been very expected, right? When we started this or again, I'll say when John started the process two years ago, there was a large population of untapped collection opportunities that were identified, very focused efforts were put on those and they definitely bore fruit and we saw a bolus of those collections come in 2023. So we've had great success. And the nature of our business, there's always going to be opportunities to capture prior period collections, especially as we continue to just enhance our collections appeals process. But we also believe that we've captured most of the low hanging fruit dating back to 2023 and pre-2023. And as we develop more history with our payer population, we also become better at estimating expected payments and adjusting our rate accruals. So the differential between expected payments and actual payments will continue to narrow and that will reduce the size of our prior period collections. But just to point out with all that said, even as the greater than 12-month collections or prior collections have tapered, we're continuing to see expansion in our ASP. So we feel really good about that.

Okay. And maybe I guess, for John, with the five abstracts you have out, I know you have 1 plenary sessions and posters and whatnot. Maybe can you just pick out, what's most exciting? I know you talked in the prepared remarks in terms of not only an impact on price, but also I think notable impact you expect on volume given the improved utilities. So maybe just walk us through a little bit about like what's in what really stands out to you from the abstracts. You've done all these meetings with doctors. Maybe just walk through kind of what the initial feedback looks like and if you can help us characterize like where you are today from a penetration basis and what this increased utility might mean in terms of penetration of volumes?

Absolutely. Good morning, Dan. Thanks for the question. So most excited, if you were to ask clinicians based on some of the feedback, where are they most excited? It was actually a surprising kind of response that I started to get over the last several weeks, couple of months. And what we're seeing in terms of interest is a lot of people curious about the seronegative RA markers that we're bringing to market. So we have two phases of this product enhancement. The first one launches by year end. The next one will be sometime here in 2025. Our abstract includes the clinical validation of both sets of markers. So by the time we've revamped our seronegative RA profile, It'll be best in class in terms of the ability to diagnose and identify patients with RA. So right now, if you were to use conventional testing at other labs, generally, you'd find about 70% of RA patients. That other just shy of a third would be identified clinically. So there's no biomarker in their serum, in their blood, which denotes the diagnosis. But through a clinical evaluation of their joints and whatnot, they're diagnosed as having RA and they start treatment. The trouble with those folks is as they progress through their treatment regimen, either they become refractory as roughly half of all patients do, then the clinician starts to question, did we get the diagnosis right, or are they truly refractory to this treatment? And it becomes a you second guess yourself quite a lot. And clinicians have told us firsthand that this is a very difficult patient population to manage because of that dynamic. Also, prior authorizations for many of these drugs become more difficult as you don't have biomarker evidence to support the diagnosis. So, working these…

Terrific. Maybe I can just sneak in maybe another quick one or two. So I think, your existing test maybe has, correct me if I'm wrong, is it 12 biomarkers on it and you're looking to add another six codes? So is this a very simplistic way? I mean, I don't know how the price per code works out. I know we'll get more color as you kind of get these pricing in place, but it sounds like 18 divided by 12 might be like a third higher. So I don't know if that's not a bad place to kind of start for us right now. And then B, I think you talked about being free cash flow positive by year end 2025. So I think your prior guide was cash on the balance sheet was sufficient to get into 26. Like how does that change now? I mean, do you think you're kind of going to be sufficient now to fund towards free cash flow positivity, so you're not going to need to raise any more capital even in the out years? Thank you.

Yeah. Great question. So on the coding front, we actually have the current AVISE CTD test has 23 markers, 10 of them are build out using our PLA code. So that's how you get back to that 12 number that you just referenced, because we have an index score associated with our lupus algorithm and so those 10 biomarkers are not ordered individually, they're ordered as a package, built out as a package and the index applies in that context. So this is adding five additional markers, three on the flow side, two on the ELISA side. Again, we'll see how reimbursement shakes out here over the first couple of months of launch, but hopefully that gives you some color. It's the PLA code plus, call it, 17. Then on the cash flow positivity, you hit it right on the head. From our standpoint, we do have ample capital to get to cash flow positive state and that is what we are laser focused on. From a runway standpoint, we're transforming this organization. I believe that we're currently undervalued relative to where we're at in that transformation and the inflection we believe we're about to take with the launch of these new markers. We've been highly committed to shareholders in creating shareholder value. So at the current valuation and that coupled with our ability to consistently push out our runway, we're not in a hurry here to do any sort of financing. From our standpoint, want to see how the new product launch goes, want to see how our financial progress, operational progress goes over the next 12 months. We will need to do something about our debt maturity at some point in the next year or so, call it year 15 months. But Jeff and I are strategizing now on that front and don't have anything to share specifically. But, that's really how we're thinking about it.

Terrific. Thank you.

Thank you. The next question comes from the line of Kyle Mikson from Canaccord Genuity. Please go ahead.

Hey, guys. Thanks for the questions. And hey, Jeff, good to work with you again. So just on the fourth quarter kind of implied guide here, it looks like $15.5 million that's like a $3 million increase from 3Q, maybe like $1.8 million if you head back that $1.2 million from the 1% headwinds in 3Q. Maybe I'm not doing the math right. But either way, there's like a nice step up there. And that's it's interesting because the fourth quarter is typically not the strongest quarter for Exagen given conferences and given some of the seasonal dynamics and stuff in lupus and rheumatology. So can you talk about what's driving that sequential increase, that delta there? And is there any like read throughs into like early 2025? Thanks.

Sure. So good morning, Kyle. Thanks for the question. I think we'll be happy to work through the math with you. Certainly, I didn't quite follow all of it. But when I see kind of how this quarter shaped out, it was as expected and as I relayed on the prior earnings call. So we saw a small quarter-over-quarter decline in volume but still had performance above Q4 of 2023 and Q1 levels, where I had conveyed that we expected kind of the bottom in terms of volume. We had very nice growth in Q2 and then relatively flat here into Q3. We really just saw the impact of some high-volume riders out of the office coupled with some weather-related effects at the very end of the quarter. On the ASP side, we had less than prior period collections or collections greater than 12 months. This was actually the lowest quarter. Jeff referenced this as well, but the lowest quarter for this since I've been here. But we still improved our trailing 12-month ASP, which is the appropriate metric to be gauging in terms of how our strategy is working. What I didn't expect was to have the negative adjustment. We're transforming this business. There's going to be headwinds and tailwinds at times. We had a headwind event, but we're not facing robust headwinds impacting the viability of our strategy. So happy to work through the Q4 math with you. Our guide is on top line 55 to 56. We think that we have good visibility into that range here at year end and then keeping the adjusted EBITDA performance at no worse than $12 million which continues to be a dramatic improvement year-over-year.

Yes. Thanks for that, John. Appreciate that. And it's not yes, just by the way, it's not as much of a step up as I was talking about, but it is like a little bit of a step up. But again, without those one-timers in the third quarter, it's kind of like sequentially flat, which is what I guess makes some sense. But yes, we can kind of talk about fourth quarter offline. On the kind of the path of profitability and everything, that's great that a little bit kind of pulled forward and everything. I think like last quarter, it could have been during follow up, but we were talking about how some of the metrics that you want to describe as being kind of like the run rate revenue level for profitability, gross margin, those are now updated. So maybe at the lower revenue level at like $70 million to $73 million by the end of next year, it sounds like. So is something like that possible? What do we think about kind of modeling second half of next year, fourth quarter of next year? I know it's far away, but like you have visibility to breakeven and all that. So if you could just comment on that, that'd be great.

So your math there, we are very much in alignment, Kyle. So from a run rate perspective, we expect by the end of next year to be in a cash flow positive state. That's somewhere in the low to mid $70 million top line with 60 plus percent gross margin and holding our operating expenses relatively flat.

All right. Awesome. And then if I could ask you to wrap up, the markers a lot of talk about the markers in the fourth quarter being launched here. Can you just walk through the marketing and the reimbursement factors that are going to kind of enter a successful launch next year throughout the full year and kind of going forward, given the importance to the P&L and everything there? I just think that there's a lot of moving pieces and it's the first launch of a new product for the company in years. So give me a good kind of walk through at this point.

Yes. And this is where a lot of our excitement is, obviously, almost all of our focus right now. So marketing wise, our marketing efforts have been ongoing. We've done quite a bit of market research throughout the last couple of quarters, refining our requisition, the report templates, how we convey the results. This is not something to be overlooked certainly. You can really mess this up or screw this up if you convey the wrong message, make too strong of claims, relay the results in a way in which clinicians are pigeonholed into certain decisions. So it's really kind of a little bit of a dance, to figure out how to end up with a product that is relatively universally liked and yet these are new markers. So you have to educate on the utility. So you have to be fairly prescriptive in your interpretation. So a lot's gone into that. As I said, we've met with multiple clinicians one-on-one, we've done larger gatherings, 70 plus on that front. So hundreds of clinicians now we've met with to get this feedback and across the entire U.S. Our team's really done a great job there. Additional marketing efforts that are ongoing. So this coming weekend and really it starts here on Thursday, but is the annual societal meeting for rheumatology. This is when our original campaign starts. This is a venue where north of 10,000 clinicians in the rheumatology community, overseas, international, U.S. based, but it is certainly the largest gathering for our specialty, occurs. And we're doing a full marketing push here with individual meetings, collateral, education. This is really our marketing launch, if you will. Although the test won't be available until we get New York State approval, but given that there is some flexibility and when that…

Okay. That was great. Look forward to ASR Communications. Thanks, John.

Thank you. The next question comes from the line of Ross Osborn from Cantor Fitzgerald. Please go ahead.

Hi. Good morning, guys. Thanks for taking our questions. So would you walk through your capacity expansion initiatives ahead of incremental demand next year?

Hey, Ross. Good morning. So capacity in the lab, the way we operate right now on a Tuesday through Saturday shift, and it's mostly a full day shift. So we've got kind of two day shifts there. We start early, five in the morning and we go late to about nine at night. A lot of that has to do with the viability of our samples. So if you keep in mind that we ship from all over the U.S., it arrives daily, call it early morning. But then for flow cytometry, we're evaluating markers on live cells. So you want to act as quickly as possible. Viability is really key with that platform. And so we typically conduct all that testing same day or done by 9 pm. We have the capacity to have a night shift, which in essence would virtually double the current capacity of the lab. So you see us doing about 130,000, 135,000 tests a year, the last couple of years. In essence, with our current instrumentation and existing capital footprint, we would be able to virtually double. Now we haven't geared up for that. What we've been doing is we've added additional licensed personnel. So that's actually currently baked into the cost structure of the organization here in, well, I guess it'll end up being the fourth quarter financials. But it started in the third quarter. And that's just really in preparation because licensed folks are really difficult to find and you need to find good ones and what have you. You can train and provide career paths for non-licensed folks and get them into different aspects of the lab, but I think, you know, kind of a bottleneck there would be licensed personnel. I feel very comfortable with where we're at to kick off the year from licensed personnel standpoint in the lab, the amount of instrumentation we have or need and then the ability to add in an additional shift should we get to that point. I really hope we do, but should we get to that point. If you recall, we made about $1 million in capital upgrades in Q3, started actually a little bit in Q2. This was to upgrade our flow cytometers so that we could handle the new T cell markers. But all that's been done, been completed and expensed.

Okay. Sounds great. And then any update on the biopharma contract you announced last quarter? How should we think about that opportunity in 2025?

Great question. No material update to present aside from the message I wanted to convey last time, so just reinforce here again, is just that it's an area of the business I don't think we had taken advantage of historically, at least in the way that I was looking at it to aid in marker development and to potentially supplement some of our R&D. This year in 2024, we signed material contracts, especially relative to our prior CRO work. So, north of $1 million this year and we'll see how that translates into future years. But we're establishing good relationships with these pharma partners. I just think it's an area we can grow over time. We haven't guided to it in 2025. Obviously, at some point early next year, we'll be able to have our guidance for 2025 and be happy to go into that a little bit more.

Okay. Sounds great. Thanks for taking the questions.

Thank you. The next question comes from the line of Andrew Brackmann from William Blair. Please go ahead.

Hi, guys. Good morning. Thanks for taking the questions. I'll just stick to 1. John, you sort of talked about some of the specific feedback that you've gathered from physician groups ahead of launch here. Can you maybe just unpack that a little bit more? And related to that, you talked about a new test report and streamlining the workflow. Anything specific you can share there? Thanks.

Yes. Good morning, Andrew. Thanks for the question. So, if you think about it, we already AVISE CTD today is already the most sensitive assay available for evaluation of folks with connective tissue disease, but specifically SLE, systemic lupus erythematosus. So, we're enhancing that value proposition, but we already have the best product out there. So, as I've understood it in talking to clinicians, you're making the best product out there better. That does have utility. These markers have IP through 2035. So it continues to reinforce that edge for us and furthers our competitive moat, if you will, in that regard. But people are used to it, having the best product out there. And so, for those folks that are already using the AVISE platform, I think they're more interested in the ability to use this more broadly, specifically with some of their rheumatoid arthritis patients. So, that's what I was getting at. Now, launching the new T cell markers will certainly open doors with other clinicians who don't currently use our platform. And we believe that there's room to be gained there as well. And in essence, some of the performance we're seeing on the SLE side is we're identifying 90% of patients or more. So it's really substantial and dramatic when normally this is a clinical diagnosis and you're able to have that level of biomarker sensitivity, certainly aides and you're capturing basically twice what conventional markers are able to capture. So we are still excited on the T cell side. But just if you take a look at it, we're initially launching within our existing customer base. And so a big part of that is, well, where else, can this help me in my clinical practice? And that's certainly on the RA side. So that's what…

Andrew, do you have any further questions for the management?

That’s it for me. Thanks, guys.

Thank you. As there are no further questions, I now hand the conference over to John Aballi for his closing comments. John?

We believe 2025 will be a really exciting year for us. We anticipate making material progress in achieving cash flow positivity. We have our new product launches planned with a return to commercial expansion of our sales territories starting again. We've been developing our R&D pipeline, and it's really starting to take shape and yield results. And we have the processes and people in place to execute a highly efficient diagnostic business and are building momentum. I look forward to continuing to detail our progress as we close out a fantastic year at Exagen and our teams are highly focused on ensuring we have a successful product launch to kick off 2025. I just want to thank the Exagen team and look forward to continuing to provide updates. Thanks so much.

Thank you. The conference of Exagen has now concluded. Thank you for your participation. [Operator Closing Remarks]