Greetings. Welcome to the Exagen Inc. Second 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] Please note that this conference is being recorded.

At this time, I'll turn the conference over to Ryan Douglas with Investor Relations. Ryan, you may now begin..

Good morning, and thank you for joining us. Earlier today, Exagen Inc. released financial results for the quarter ended June 30, 2024. The release is currently available on the company's website at www.exagen.com. John Aballi, President and Chief Executive Officer, will host this morning's call.

Before 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 are 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 and 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.

For a list and description of risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2023, our Form 10-Q for the quarter ended June 30, 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 principles in the United States or GAAP. These non-GAAP items should be used in addition to and not as a substitute for any GAAP results.

We believe these metrics provide useful supplemental information in assessing our revenue and operating performance.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has 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, August 5, 2024. Exagen 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.

I will now turn the call over to John Aballi, President and CEO of Exagen..

Thanks, Ryan, and good morning to everyone joining the call. Today, I'll provide updates on the progress we've made over the last few months and continuing to reshape Exagen for long-term profitable growth, including details on our second quarter financial performance.

The results of this quarter are really starting to demonstrate a track record of performance and progress towards our goals. Our results over the first half of the year and specifically the trajectory over the last 18 months, has shown that we can grow and expand our business while simultaneously pursuing profitability.

To that end, this quarter, we delivered a $1.6 million adjusted EBITDA loss. 53% improvement year-over-year and the best quarterly financial performance in Exagen's history. And with the first half 2024 adjusted EBITDA loss of only $3.6 million, we continue to make major strides on both top and bottom line performance.

As I look back at where we were just before I joined Exagen, our progress is truly impressive. In 2022, we delivered $45.6 million in revenue, but our adjusted EBITDA loss was $40 million and accelerating. Our gross margins for that year were just under 47%.

Sitting here today, we have reshaped Exagen into an exciting business, which is on pace to achieve profitability. We've grown our quarterly revenue almost 30% from average 2022 levels. And this year, we now expect our full year adjusted EBITDA loss to be on par with what we used to lose every quarter, a 70% improvement.

Our margins have expanded 13 points over this time and we are on the cusp of further margin expansion with enhanced IP protection on our core product, all while revamping our R&D pipeline and deleveraging our organization. I'm incredibly proud of the team for this transformation and astounded by the progress we've made in such a short period.

This past quarter, our team grew testing volume 8% sequentially which was our best total quarterly volume since we made adjustments to our ordering process last summer. It is exciting to see the momentum in test volume growth as we expected.

Our sales team is making great progress in serving the rheumatology community, and they are energized by the successful quarter after working through significant change management with our customers over the past year. Additionally, we continue to increase our trailing 12 month average selling price for AVISE CTD.

And for the first time as a public company, are seeing ASPs exceed the $400 mark. This is an exciting milestone and one which we are very proud of. We have made tremendous progress over the past six quarters, getting us closer to our near-term goal of attaining at least 50% of our CMS price for AVISE CTD.

The combined efforts of increasing volume and growing ASP led to record quarterly revenue at just over $15 million in Q2. I'm encouraged by the growth and trajectory I'm seeing in our core AVISE business as we continue to execute well.

Additionally, and as we've conveyed throughout the year, we've identified areas where we can enhance our existing products and services.

In Q4, we expect to upgrade our AVISE CTD offering through the addition of markers, which we believe will improve the sensitivity for SLE diagnosis and better capture patients with rheumatoid arthritis who would traditionally be diagnosed as seronegative RA. These are the top two options by prevalence under a connective tissue disease differential.

And each of our product enhancements has a proprietary aspect, which we believe will provide significant competitive advantages. This past quarter, we made meaningful progress to advance development efforts, and I continue to expect that we will launch improvements to the AVISE CTD platform by year end.

Given our progress in improving the AVISE business, and the impact we expect from the launch of a revamped AVISE CTD profile. We expect to be cash flow positive within a year of launching both sets of new markers. Our horizon for achieving profitability is coming into focus, as we continue to execute on our strategy.

As we near profitability, we've begun to see additional areas of opportunity for growth and expansion. In the second quarter, we signed the first substantial biopharma contracts since I've been here.

This is an area of business where I believe we have untapped potential and have placed a heightened focus on better serving this segment of the immunology ecosystem. Our high quality testing, proprietary offerings and domain knowledge gives us an advantage in this space.

And we will continue to build our capabilities as more pharma companies realize the superior service and quality they can receive by working with us. Before I dive deeper into our financial performance for the second quarter, I want to extend the sincere appreciation for the contributions Kamal has made to the Exagen organization as he steps down.

Over the past decade, he has held numerous roles of Exagen and been a strong steward of the financials. Kamal has been a key supporter throughout my transition and for that, I'm grateful.

Subsequently, as we continue to execute our strategy and deliver meaningful profitable growth, I look forward to having Jeff Black join us on the executive team as our Chief Financial Officer. Jeff has been CFO of multiple public companies.

His leadership and incredible track record of value creation will be advantageous as we progress to our next inflection point.

Given our start to the year and our consistent resetting of internal expectations, now it's the perfect time to have Jeff join our mission of providing clarity and improving clinical outcomes for patients with autoimmune disease. Now to dive in.

Our Q2 performance highlights the strength of our business under our revised strategy and shows what an intense focus on the customer can accomplish. To provide a few highlights. Total revenues in the second quarter of 2024 were a record $15.1 million compared with $14.1 million in the second quarter of '23, a 6.6% increase.

Total revenues were primarily driven by strong ASPs for AVISE CTD and increased volumes over the first quarter. Growth at Exagen is now being driven through a combination of increased clinical adoption and improved reimbursement.

Other testing revenue was $1.5 million in the second quarter of 2024 compared with $1.6 million in the same period last year. Our revenue cycle team continues to do a fantastic job as we again saw strong prior period collections with $1.3 million of revenue in the second quarter from tests performed over a year ago.

Prior period collections are generally very difficult to forecast, but continue to outpace our internal projections. Cost of revenue were $6 million this past quarter resulting in a total gross margin of just over 60% compared to 58.7% in Q2 of '23. The increase in gross margin was primarily driven by increases in ASP.

Operating expenses excluding COGS, for the second quarter of 2024 were $11.6 million compared with $13.2 million in Q2 of '23. Year-over-year decreases were primarily due to a reduction in legal fees and stock based compensation as a result of lower headcount.

The net loss in Q2 of '24 was $3 million compared with a $5 million loss in the same period last year, representing a 40% improvement. Adjusted EBITDA loss was $1.6 million for the second quarter of ‘24, compared to a $3.4 million loss for the second quarter of '23.

Adjusted EBITDA loss through the first half of the year was $3.6 million compared to $9.6 million through the first two quarters of '23. 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 at our balance sheet. Cash and cash equivalents as of June 30, 2024, were approximately $24.5 million and our accounts receivable balance was $11.7 million.

Given our ability to drive profitable growth, we are increasing our full year guidance to at least $57 million in revenue and now believe our adjusted EBITDA loss will be better than $12 million, which is a dramatic improvement from our expectations just six months ago.

Again, the launch of the new enhancements to AVISE CTD is expected to make us cash flow positive within the first year of launch. We will now open the call for questions..

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. And our first question is from the line of Kyle Mikson with Canaccord Genuity. Please proceed with your question..

Hey, guys. Thanks for the questions. Congrats on the results. I guess maybe, John, just on the ASP. So I think last quarter, maybe fourth quarter itself was just above $420 or so. Now it was maybe just about $400 maybe, $410. It's kind of stabilizing a bit at $400.

I mean, how long could it take to get to $500 or so, like 50% of the list price or the Medicare price? And is that -- how critical is that? And could you take a step back and maybe try to reinvest to like drive volume growth rather than ASP? I mean how are you thinking about that? Are you kind of closing on this target here?.

Good morning, Kyle. Thanks for the question. Very relevant. I think it's a good one. So the way we look at ASPs and our ambition there has not changed at all. Our goal has been, over the last couple of years has been to achieve that 50% level in the relatively near term. For AVISE CTD that's somewhere around $525, just over that $500 mark.

And so we pointed folks to the trailing 12 month number, really in anticipation of the quarter-to-quarter variability that we expected to see. We think we've had a great quarter and we continue to push the AVISE ASP up. And so from our perspective, the view really hasn't changed.

So while you see that quarter-to-quarter transition, there's nothing meaningful really behind that in terms of negative trends or anything like that. So our goal store remains the same. We've never really guided to an exact time point as to when we believe we'll hit it. It's just inherently difficult to forecast.

Some of these things that really drive momentum can be changes in payer behavior, but also things that we can do, but our appeals efforts remain strong. We're starting to get some of that feedback in, now that we've completed three or four levels of appeals.

And so we still remain just as optimistic as we were maybe even more so given the progress we've made over the last several months..

I got it. Sounds good. Thanks for that. And then, we kind of implied or like inherent in that question was just kind of the investment in commercial key, commercial expansion, driving volume growth rather than ASP, and collections and things like that.

So, SG&A has been pretty stable the past couple of quarters last year, the level -- the quarterly level is much higher.

I mean maybe just refresh us on the plans to increase the sales force and kind of expand your reach penetration in the rheumatologist market in the country?.

Yeah, absolutely. So, the exciting thing for us is, we had anticipated reshaping the organization. And from a strategic standpoint, at the heart of what we're doing is, is driving ASP improvement. If you recall, that has not really been done at all for the four years prior to me joining the organization.

And now we've seen a 40% increase from 2022 levels. So we're being successful in that regard. At the same time, it's required us to reset some of the ordering process with our clinicians, and that had, what we call the kind of a transient effect on our volume, and that sort of kicked-off in this time last year.

And from our perspective, Q2 now, we've seen that volume growth and that was what we expected. That's been the plan all along. Timing is kind of right about what we expected as well. So I couldn't have drawn it up any better as we see it. And where we sit now, this is really growth due to two different levers. One continues to be on the volume side.

One continues to be on the ASP side. You asked me specifically, about growing the sales team, we continue to have a 40 territory footprint across the United States. We believe for now that is the right footprint. We've rightsized the organization when I first started.

And then, with the volume impact last year, it's still the right-sized organization for us right now. We continue to monitor each territory for profitability. And we'll split those territories or expand into areas that we're covering with an inside sales force over time, but nothing new to report there.

I do think in terms of the operating expense in general, [indiscernible] for SG&A is likely a little low. We're going into a product launch here in the second half of the year, product enhancement in two fronts. So our marketing expenses are likely to increase.

As we do that, we may also incentivize the sales team in different ways throughout that period, and we'll have to see how commissions break out.

But overall, operating expense kind of coming in under 18 is probably not the best way to model it, right, in that 18 level is probably reasonable, especially when you factor in our R&D expenses are likely to increase as we move through validation of these different enhancements. So hopefully that gives you some color..

Yeah. That was interesting. Thanks for that. And then, I guess just moving to the third quarter. It's kind of, in the end of the year is interesting for Exagen given some of the industry dynamics and stuff conference ACR, I think, November.

So how should we be thinking about the third quarter, fourth quarter kind of cadence as you accelerate into 2025, I guess? And then maybe talk a little bit about how you feel about core growth, like, excluding the prior period collections heading into year-end kind of thing, just given the momentum into business recently?.

Sure. So are you also -- are you asking more on the revenue side, adjusted EBITDA or the entire picture..

The top line revenue?.

So in the second half of the year, we typically or historically have seen some seasonality impact. We're certainly seeing this with some of our top clinicians, extended vacations. You see it in the news. Airports are extremely busy when our team is flying, when I'm flying. So we do see some of that impact right now. We expect to continue into Q3.

As you referenced, Q4 has the most holidays out of any quarter in the year. And for us, we have a rheumatology societal meeting in the month of November, the week before Thanksgiving. So that pulls a good chunk of the rheumatology community out of clinical practice for at least a week, and then it piggybacks onto a holiday week.

So we do see either a flattening or even slight decline historically. We're working hard to change that trend, and I think the team is highly motivated to do so, especially in light of a few product enhancements, which were coming over Q4. So from our perspective, we'll have to see exactly how it shapes out.

But if you look at the first half of the year and remove out of period revenue, that $2 million in prior period collections, basically, the guide that we've provided takes into account the sentiment I just conveyed. And that is that relatively flat due to seasonality impact as we continue to grow into 2025..

Okay. That was great. I'll leave it there. Thanks, John. And definitely, it was great working with Kamal and good to see Jeff on board now. Thanks..

Great. Thanks so much, Kyle..

Our next question is from the line of Mark Massaro with BTIG. Please proceed with your question..

Hey, good morning. Thanks for taking the questions, John. Maybe the first one, this I think is obvious, but it looks like you beat in Q2 by $2 million. You raised the full year guide by $2 million. Just confirming that you're not changing how you expect trends in the back half of the year. Obviously, I heard your comments about seasonality.

But you had a strong 8% quarter-over-quarter, excuse me, 8% quarter-over-quarter increase in volumes. I assume you're not expecting or embedding in your guidance any change to the volume trajectory in the back half of the year relative to the prior year.

I guess I'm just trying to confirm that the raise for the full year was a function of the outperformance in Q2 and not changes to your underlying trends in the back half?.

Sure. Good morning, Mark. Thanks for the question. As you said, no, there's no changes in expectation for growth of the business. We've said that projections of ASP increases over time are inherently difficult just given the magnitude and the dependencies on certain payer behavior.

So that's always a challenging thing to forecast, that's one lever of our growth. From a volume standpoint, the 8% sequential growth quarter-over-quarter, that's fantastic. Just historically, Q3, Q4 has been kind of a leveling. Q1, Q2 has been really where we build from a volume standpoint, but we'll see.

Again, like I said, the sales team, this is not the message to them. This is just if you look at this from an analyst standpoint or evaluate the business, these have been historical trends that seem to sit within the rheumatology community and the way clinical practice is handled here. So no change in terms of our outlook, so very optimistic.

Like, the trajectory, like, both levers are leading to growth here, and we'll see kind of how we perform in the back half of the year..

Okay. Great. You mentioned the biopharma ad. Nice to see. I know that used to be a pretty significant piece to the Exagen business strategy over the years, going back to the IPO. Can you maybe just remind us how many of your 40 or so reps, I mean who's driving the pharma demand? I can't imagine it's all 40 of your reps.

So is there a specialized team? I could probably use a refresher on that? And then, how should we think about biopharma over the next couple of years? I mean I don't expect huge wins in the near term per se.

But just curious how you view this test and treat strategy and what types of deals you're looking to sign?.

Absolutely. This was a great development for us in Q2. And just to be clear, our business model is to serve the community based rheumatologists in their clinical practice, that's where AVISE CTD holds the greatest clinical value is in the day-to-day management of patients with suspected underlying connective tissue disease.

So our biopharma revenue and especially, the contracts that we've signed more recently are not in that vein. And we don't dilute the message from our sales organization in this regard. So we have under our Chief Medical Officer, Dr. Mike Nerenberg.

We have established a small team, a small biopharma team, and they've been actively working for the last nine months or so, in seeing what businesses out there. And it seems to be some initial good feedback is really the message I wanted to convey. It was great to see the new contract come in. We do offer a differentiated service in this area.

We're known for our high quality testing. We have proprietary markers for clinical trials, enrollment that is or further characterization in these patients. And so that combined with the quality of testing that we perform, we're starting to enhance our build the brand within the pharma community. And so, we'll see how this business evolves.

I'm sure you're aware in some of the other companies that you follow biopharma revenues incredibly lumpy and also difficult to forecast.

So layering some of that stuff on, but we'll take it because it tends to be a higher margin business and then also, from our standpoint, we've adjusted the way that we set up these contracts so that there is some level of minimum performance. So we do expect this to be a meaningful impact to the organization. Hence, my reason for mentioning it.

But unsure exactly how big or large of a business this can become just seems to be a good first start. But it is a separate team..

Okay. Got it. I will also reiterate my pleasure working with Kamal over the years, and welcome, Jeff, to the organization. But I want to put my third question here on the T-cell markers. So I know you've talked about being able to identify more patients with SLE, who authorize would have tested negative.

So inherently, I think that provides a significant opportunity for you. But I'm just curious if you've had additional time perhaps to think about what that opportunity could mean in dollars because I think people are trying to figure out the incremental, I know some companies who launch next-gen (ph), there's not always a revenue inflection.

Perhaps it's greater ease of use or there are other characteristics of the next-gen launch.

But over the next several years, how should we think about the incremental change in demand for Exagen and then as it relates to pricing, do you see any potential path to get a higher price from payers as a result of the next gen?.

That's a great question. So to explain to everyone, one of the things that makes AVISE CTD unique and so valuable to clinicians is that we've taken the time to research and then subsequently demonstrate through our own trials what the most relevant markers are for aiding a diagnosis when a broad differential is being evaluated.

So these product enhancements, they, as you mentioned, Mark, improved the sensitivity of two sub profiles within AVISE CTD. So specifically within the systemic lupus erythematosus and the rheumatoid arthritis sub profiles. So these enhancements will be available individually but also as part of a revised CTD offering.

We do expect an immediate clinical benefit to physicians, but also to reflect that benefit in ASP virtually from launch. So I'd like to see exactly how that reimbursement lands once we start getting claims adjudicated, but I said it will be margin accretive and meaningful.

We've also now come out and said, with this earnings call that within a year of launching both product enhancements that we expect to be a cash flow positive organization. And historically, we've said that we reached that level with 60% margins and around $75 million in revenue.

So from a run rate standpoint, our organization is starting to move in that direction. And at least our initial projections are that we're there towards the end of that first year of launch of both product enhancements. So that's how we're thinking about it internally.

You never really have certainty until you start to get some of those claims adjudicated and see how it goes. But these are additional markers that we're adding into CTD so that you understand kind of operationally, how this is being handled.

Volume impact, it takes time to educate folks on the utility of these new markers, what value they bring clinically, how to use them. And especially, we're doing it across two disease states. So that will take some time.

As we're looking at it, about a year is, what our current expectation is to get a full realization of the ASP impact, gain confidence there, but also to get that message out and have it resonate with clinicians such that we're driving volume.

And that combination likely gets us above that 60% level, kind of in the low-60s is how we’re looking at it from a margin standpoint and then having our top line kind of hit that mark of cash flow positivity..

Okay. Great. Congrats on this current quarter..

Thanks, Mark..

Our next question is from the line of Dan Brennan with TD Cowen. Please proceed with your question..

Great. Thanks. Thanks for the questions. Maybe the first one just on the better-than-expected kind of EBITDA levels that you're seeing $3.6 million loss in the first half. I think the guide now you raised by $6 million, right, from $18 million down to $12 million, so really nice raise. Arguably still looks conservative given the first half run rate.

Could you just speak a little bit more to how we think about cost trends in the back half of the year? I know you discussed the new products and what that's going to entail. But I'm just kind of trying to put how like a $3.6 million first half loss translates into a $12 million full year loss..

Great. Good morning, Dan. Thanks for the question. Certainly a good one, highly relevant. The way we look at it, we're being very prudent with managing expenses of the organization. But from an OpEx standpoint that less than $12 million per quarter is not a run rate to model.

So we do expect some of our cost to increase, especially, when you're launching two new product enhancements. As you would expect, we're going to have a marketing campaign associated with these product enhancement launches. There will be some commission impact from a sales standpoint. There's also some increased R&D expense.

The methodology for one of these product enhancements is flow cytometry. We have to have prospective samples in order to validate this assay. And so, we're running a clinical trial from that, and we have to time everything perfectly so that we validate when the assay is ready, and we're ready to do that analytical validation.

So those expenses are likely to increase in the back half of the year. So that's what we factored in, in terms of our guide on the adjusted EBITDA side. Also, as we've said, it's very difficult to forecast prior period or out-of-period collections. And so we had $2 million in terms of the impact here in the first half.

We're working hard to see what we can collect in the back half of the year. But we do expect this over time to continue to reduce as it gets factored into the accrual rate. So I think those two factors are important to keep in mind.

The other thing maybe I'll just point you to is, in our 10-K, maybe you would have picked up on that we had 170 FTEs here at Exagen at the end of last year, that number is likely a little too low. as we've gone through the year. It's not going to be dramatically above that.

But there were a few key positions that we had to fill within the organization here have done so more recently. And so those are all factors that we're taking into account..

Got it. Thank you for that. And then maybe just on the new markets, I know on the last call, you discussed some of the performance enhancements in terms of the area under the curve and better sensitivity and kind of those factors.

Could you just maybe speak to a little bit of like what you're hearing from the field as you get ready to launch these products like from a kind of volume basis, what kind of maybe penetration increases could entail just given the better performance, could you kind of shake some of the doctors that haven't been using the test kind of into your user base because of that? Just any color there would be helpful..

Certainly. So timing-wise, we're going to certainly have a large educational campaign here in Q4 as we get close to launching these. And it just happens kind of perfect timing, if you will, that the rheumatology societal meeting is also in Q4.

So we'll get a lot of feedback here in the month of November as we work with folks, but we've done a lot of market research up to this point. And pretty universally, the feedback is very positive. Clinically, this is a challenging dilemma for folks. You've got suspected connective tissue disease differential with the patient.

And the more accurate test that you can provide the better, that's why they use AVISE CTD now, and we're making it only that much more improved. So from our standpoint, the feedback has been very positive. It certainly continues to address a high clinical need within the rheumatology community. We'll see exactly how it shapes out volume wise in 2025.

But positive so far has been key -- feedback so far has been very positive, excuse me..

Got it. And then maybe last one in terms of the claims that you've been holding. Just kind of remind us, like, are you fully kind of processing a lot of the claims given where pricing is today? Just how do we think about that as we look out to the back half of the year end of '25..

Yeah. So at the beginning of each year, we hold claims as a strategy that we have that we believe improves our revenue cycle opportunities and so we do that. And then, in late Q2 into Q3, we released those claims out to the various insurance organizations and then go from there. And so, we've done that here in Q2.

You see our AR increased by about $1 million. Our cash position is very strong. So, is played out or is playing out very similar to how it did last year. And we’ll see kind of how the back half of the year goes in terms of this, but claims are being released and it’s just business as usual in that regard..

Great. Okay. Thank you very much, John..

Our next question is from the line of Ross Osborn with Cantor Fitzgerald. Please proceed with your question..

Hey, good morning, everyone. Congrats on the results. Maybe starting-off with just a bigger question from us.

Given your success in turning Exagen around the drug in an efficient manner, how are you thinking about the longer-term story at this point? Just in terms of your product portfolio, with the business reaching cash flow breakeven in a year or so, are you thinking more about bringing in a new test at this point or is there a runway for the AVISE CTD test in that it will be the focus for the next several years? Thank you..

Hey, Ross. Good morning. I appreciate the question. It's a fun question to ponder. To be honest, especially, given where I joined the organization a couple of years ago, it was something I thought about, but wasn't quite at the forefront of what I had to work on. And so, it is coming more into view. I appreciate that perspective.

From our standpoint, the organization is transforming and we've shown material progress. that was -- it's exciting to see and it's exciting to be operating a business that is very close in this regard, right? And I think that, that's certainly what I've wanted to do, and I'm really looking forward to it over the next couple of years.

I think we'll be able to do some fun things as we move into more capital allocation type strategies. And so from our perspective, AVISE CTD still has quite a bit of room to go.

If we take a look at how we're thinking about this, 40 million to 45 million Americans are ANA positive and then subsequently referred into rheumatology for clinical evaluation of suspected autoimmune condition. We think that we're somewhere kind of mid-single digits in terms of market penetration with AVISE CTD.

So we've got a lot of room on that front. I think these new product enhancements, we'll see how they work in terms of clinical adoption and what the impact is there. We also think that from an ASP perspective, we still have some room to go.

And as I mentioned, kind of that 500 mark is a good clip, so that's a decent growth from our perspective, just on the base business. Additionally, one of the things we've done over the last two years has completely revamped our R&D efforts. And we do have exciting opportunities there.

The rheumatology community, this is not the only area where they need proprietary information and diagnostics. And so, disease activity scores, both in SLE, along with rheumatoid arthritis or something that we're actively looking at. We've also looked at diagnostic and therapeutic response Within a subset of SLE patients, those with lupus nephritis.

And there's a few other efforts that seem to look promising from the research that we've done. So we'll continue to build out our own pipeline of opportunities and first and foremost, it starts with customer need. And I think we've got a good handle on that.

But then we'll also, as we become a cash flow positive and subsequently a profitable organization, look for what else is out there and see how we can enhance our business profile in that regard from an inorganic opportunity standpoint.

So fun to be thinking about it, that was one of the reasons why I'm super excited for Jeff to join and be able to leverage some of his experience there. So we'll see where it goes..

All right. Sounds great. Congratulations on the progress. Thank you..

Thanks, Ross..

Our next question is from the line of Andrew Brackmann with William Blair. Please proceed with your question..

Hey, guys. Good morning. Thanks for taking the question.

Maybe on the AVISE enhancements, can you maybe just be a bit more specific on training and education plans around these ads? Anything that we should sort of be on the lookout for, whether it's industry conferences, KOL, events, peer-to-peer, anything like that in the back half of the year? Thanks..

Good morning, Andrew. So it's already started in terms of internal training. And the month of August will actually be a heavy month training wise for our organization.

We're having regional meetings within our sales organization, pulling them into centralized locations and spending two days of really diving deep into the clinical value proposition and the clinical benefit that these markets are going to provide.

The team has been preparing for this for a couple of months now and I will be attending portions of those. So very excited to see kind of where we sit internally from a training standpoint, call it, end of August, beginning of September. So those are some internal efforts. Obviously, we're revamping all of our marketing material.

Our AVISE CTD report is changing as a result of this. We're taking that opportunity to enhance the way that we provide just even the AVISE, the standard AVISE analytes, but then also these new ones. Our interpretation on that report is changing, and it will be very educational there.

There's -- be happy to show and share some of that stuff as it becomes fully mature, but maybe in the next month, 1.5 months, that will occur. As I mentioned, ACRs in the month of November, that's going to be a key date for us. It's mid-November there. We'll have a strong educational campaign.

We are already slated to have some presentations there on these topics. And so excited to get that information out there and really start the commercialization of these enhancements.

So those are the main things that are occurring and then we'll see, we're also in the midst of publishing a couple of manuscripts, which highlight the studies that we've run, clinical validation, if you will, of these markers.

So those will hit the public domain ideally sometime before the end of the year, tough to control publication time lines, but ideally before the end of the year. So you'll see those things at the public domain. And then obviously, we'll see the reaction from physicians probably here manifest in Q1..

Perfect. That's actually a good segue. It's where I wanted to go next really just around sort of data generation. So it sounds like you've got some the manuscripts coming around validation. But anything that we should be on the lookout in terms of clinical utility studies, how are you thinking about the importance of running those? Thank you..

That's a great question. Clinical utility is a key part of reimbursement in this space is something that we're at the heart of our product enhancements and product launches. We have clinical trials set up with folks, and we're in discussions with others taking a look at clinical utility.

It will be a little soon to demonstrate clinical utility exactly when we launch these markers, but it is something that we are actively working on and more to come maybe in 2025 as those trials continue to enroll and we start to see the results of some of it.

So right now, focus on analytical validation, clinical validation, both of those results from initial readouts are very strong. It’s the reason we’re launching these. And then subsequently, we’ll look to see how clinical behavior is enhanced with the launch of these markers here in ‘25..

Great. Thanks..

Thanks, Andrew..

Thank you. We've reached the end of the question-and-answer session. I'll now turn the call over to John Aballi for closing remarks..

Great. I want to end by extending a huge thanks to the team at Exagen for executing at a very high level and continuing to trust in the process and buy into the changes we've made at the organization. As we continue to evolve our business, our performance is showcasing the transformation. It's exciting to see.

It continues to be exciting to convey, and I look forward to providing our next update in a few months. Thanks all..

This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation..