Exagen Inc. (XGN) Q4 2023 Earnings Call Transcript

Exagen Inc. (NASDAQ:XGN) Q4 2023 Earnings Conference Call March 18, 2024 8:30 AM ET

Company Participants

John Aballi – President and CEO
Kamal Adawi – CFO
Ryan Douglas – IR

Conference Call Participants

Mark Massaro – BTIG
Kyle Mikson – Canaccord Genuity
Dan Brennan – TD Cowen
Ross Osborn – Cantor Fitzgerald
Andrew Brackmann – William Blair

Operator

Greetings. Welcome to Exagen Inc.’s Fourth Quarter 2023 Earnings Conference Call. [Operator Instructions]

At this time, I’ll hand the conference over to Ryan Douglas with Investor Relations. Mr. Douglas, you may now begin your presentation.

Ryan Douglas

Good morning, and thank you for joining us. Earlier today, Exagen Inc. released financial results for the quarter and full-year ended December 31, 2023. The release is currently available on the company’s website at www.exagen.com. John Aballi, President and Chief Executive Officer, and Kamal Adawi, Chief Financial Officer, will host this morning’s call.

Before we get started, I’d 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 for the quarter, potential profitability, or 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 all description of the risks and uncertainties associated with our business, please see the filings with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2023, and any subsequent filings. In addition, some of the information discussed today includes 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 substituted 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 on the Investor Relations page of the company’s website.

The information provided in this conference call speaks only to the live broadcast today, March 18, 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’ll now turn the call over to John Aballi, President and CEO of Exagen.

John Aballi

Thanks, Ryan, and thank you to everyone joining the call. Today, I’ll review our fourth quarter and full-year 2023 results, progress on our strategy to achieve profitability, and touch on how 2024 is starting out. I’ll then hand it over to Kamal, our CFO, for further details regarding our financial performance. 2023 was the year where we implemented significant change across the organization in executing on our strategy, and it’s exciting, and to be honest, a lot of fun to see the results we were able to generate in a relatively short period of time by focusing on our core product, AVISE CTD. I have to start by genuinely thanking all the team members at Exagen for putting in the hard work and effort this past year to really change the trajectory of our company. We’ve continued to serve patients in the rheumatology space with the best testing available, but are now doing so with a healthier organization, which is much closer to operating profitably. Throughout the year, my confidence has grown, knowing that many of the strategic shifts we’ve needed to make are behind us, and that as we continue to execute, our goals are truly within reach. Looking at our performance this past year, we are extremely proud that our full-year revenue was a record $52.5 million, with $13.8 million coming in the fourth quarter. Full-year revenue increased 15% over 2022, while simultaneously reducing the cash needed to run the business. This resulted in a $22 million or 57% improvement in adjusted EBITDA year-over-year. We also improved our gross margin to 56% for the full year 2023, and to over 59% in the fourth quarter. This is fantastic progress over our 2022 performance, and we are steadily moving towards our cashflow-positive target of 60% gross margins.

In achieving our 2023 performance, one of the key areas we focused on was improving the average selling price of AVISE CTD. In many respects, we’ve laid the groundwork for continued progress this past year, but also shown that we can simultaneously generate momentum in improving the realized price of our core testing. At the end of 2022, our trailing 12-month ASP was $285 for AVISE CTD testing, and by the end of 2023, we were able to increase this 18% to $336. The increase in ASP relative to 2022 becomes even more impressive when factoring in the CMS repricing of our PLA code as we transition to the clinical laboratory fee schedule at the start of the year. We are very proud to deliver a change of that magnitude without sacrificing progress in growing the business. For 2023, we delivered a record 137,000 AVISE CTD tests, of which approximately 30,000 were completed in the fourth quarter. From inception to date, we have now delivered over 900,000 AVISE CTD tests, and we look forward to surpassing the 1 million test mark later this year. In 2023, we worked hard to focus on AVISE CTD and specifically to improve the ASP of our offering. As we implemented changes to accomplish this goal, as expected, we did experience a decline in AVISE CTD testing in the second half of the year. As we’ve progressed into the first quarter, we are seeing encouraging progress in building back our business from a volume standpoint, and continue to expect growth in 2024 to be driven by improvements in ASP and increasing test volumes. When I joined Exagen in late 2022, I worked to drive focus on AVISE CTD testing, and subsequently looked for ways to improve every aspect of how we offer our tests. One area we’ve recognized as an opportunity is in leveraging some of the unique biomarkers we already had license to in order to enhance the sensitivity of AVISE CTD. On this note, we anticipate launching new proprietary T cell markers within the AVISE CTD platform in the fourth quarter of this year. We expect these novel markers will improve the sensitivity of our test in identifying patients with lupus. Ultimately, we anticipate being able to identify up to 50% of SLE patients who would test negative by standard of care testing or alternatives.

In November of 2023, we presented an abstract at the American College of Rheumatology annual meeting highlighting the gain in diagnostic sensitivity T cell markers provide, and we are working to have them clinically available to better aid clinicians and patients in identifying disease. From our research, these markers are some of the most specific for SLE that have been discovered, and will therefore be a true value add for clinicians and patients. Additionally, and from a competitive advantage standpoint, we have patent protection in offering these markers through 2035, which reinforces our commitment to innovating in this space, and further highlights Exagen as a company that can continually bring novel biomarkers to the rheumatology community. The addition of these markers to AVISE CTD is also expected to be accretive to our financial performance by the end of this year. Finally, before I hand the call over to Kamal, the goal posts are as clear as ever, and I very much believe we will achieve cashflow breakeven, with gross margins around 60% and revenue of approximately $75 million with our current cash balance. Execution of our strategy is demonstrating results, moving us closer to these goals, and I’m excited about the progress we expect this year.

With that, I’ll now turn the call over to Kamal to provide details on the fourth quarter and full-year 2023. Kamal?

Kamal Adawi

Thank you, John, and good morning, everyone. As John mentioned, total revenues for the full year 2023 were $52.5 million, an increase of 15.3% over 2022. Total revenues in Q4 were $13.8 million, which was an increase of 7.2% over fourth quarter 2022. Total revenues for the full year were driven by a combination of record volume from a strong first half of the year, and ASPs from our flagship product, AVISE CTD increasing 18% for the year. Testing volumes from AVISE CTD were 137,650 tests for the full year and 30,438 tests for the fourth quarter. We had 2,383 ordering healthcare providers in Q4 2023, compared with 2,419 for Q4 2022. The slight drop in healthcare providers is also a direct result of provider-facing changes we made that impacted volume. Again, this decrease was expected and necessary as we look to build a profitable business. The breakout of $52.5 million in full-year total revenue is $46.3 million in a AVISE CTD revenue, with other testing revenue at $6.2 million.

For the fourth quarter total revenue of $13.8 million, AVISE CTD testing revenue was $12.1 million and other testing revenue was $1.7 million. The changes made to the revenue cycle management department in the start of the year is continuing to yield results. In the fourth quarter, for tests that were older than 12 months and were not in accounts receivable, we collected and recognized $1.4 million, of which the majority came from a commercial payer. We continue to make improvements to the billing processes and strive to collect the maximum amount per test. For the full year 2023, cost of revenue were $23.1 million, with a gross margin of 56.1%, compared to $24.2 million and gross margin of 46.9% for the full year 2022. The increase in gross margin was due to the increase in ASP we saw throughout the year. Cost of revenue were $5.6 million in Q4 2023, resulting in a gross margin of 59.2%, compared to 50.9% in Q4 2022. Again, the increase in gross margin percentage was driven by an increase in ASP.

Operating expenses excluding COGS for the full year 2023 were $52.3 million, compared with $67.4 million in 2022. Year-over-year Decreases were primarily due to the decreases in employee-related expenses due to decreases in headcount and reduced R&D expenses. Operating expenses excluding COGS in Q4 2023 were $13.3 million, compared with $21 million in Q4 2022. The $13.3 million included a $1.6 million write-off from leasehold improvements from a lease we were able to exit. We were very happy to exit this lease in a very difficult commercial real estate market, resulting in significant cash savings into 2027. As a reminder, operating expenses in the fourth quarter of 2022 include a one-time impairment in the amount of $5.5 million from goodwill associated with the purchase of medical diagnostics division of Cyprus Bioscience in 2010.

The net loss in Q4 2023 was $5.6 million, compared with $14.4 million in Q4 2022. For the full year 2023, the net loss was $23.7 million, compared to $47.4 million in 2022. Adjusted EBITDA was negative $3.9 million for the fourth quarter 2023, compared to negative $13.4 million for Q4 2022. For the full year, adjusted EBITDA was negative $17.1 million for 2023, compared to negative $39.8 million during the full year of 2022. As a reminder, our adjusted EBITDA excludes stock comp expense since it is a large non-cash expense for the organization. Please refer to our earnings release issued earlier today for a reconciliation of adjusted EBITDA to net loss.

Looking to our balance sheet, I’m very happy with how we ended the year in regard to cash management. Cash and cash equivalents as of December 31, 2023, were approximately $36.5 million, up from $28.4 million at the end of September. Our accounts receivable balance at the end of 2023 was $6.5 million. As we continue to improve revenue cycle management, we plan to hold claims in the first half of the year, which will result in an increase in accounts receivable and an accelerated decrease in our cash, both returning to normal levels by year’s end. We anticipate a similar cadence in 2024, with our cash balance in AR as we did in 2023. I’m pleased with the continuing improvements made to the organization and the progress we have seen on our financial statements. As John stated, we continue to target cash flow breakeven at revenues of $75 million, and gross margins of 60%. As I previously shared, our gross margins were just shy of 60% this past quarter on the strength of improving ASPs. For full-year 2024 revenue, we’re providing guidance of approximately $54 million. For first quarter 2024 revenue, we’re providing a guidance range of $13 million to $13.5 million. For full-year 2024, we believe our adjusted EBITDA will be better than negative $20 million. Given our continued improved performance, we believe our existing cash and cash equivalents are adequate to meet our anticipated cash requirements into 2026.

We will now open the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from the line of Mark Massaro with BTIG. Please proceed with your questions.

Mark Massaro

Hey guys, thanks for taking the question. You guys talked about the change in the clinical lab fee schedule, I believe. So, can you just walk us through what the change was to your Medicare rate? I believe it went from $1,085 to $840, but I think you have an opportunity to get paid another $200 for additional markers. Is that correct? And then can you just give us a sense for whether or not you expect similar payment when you move to the new novel markers?

Kamal Adawi

Thanks for the question, Mark. Yes, those rates are correct. It did move from $1,085 to $840. When you look at Medicare as the impact it has on ASP, that is a $26 impact on our ASP. So, with the increase we’ve seen year-over-year with driving our trailing 12 months ASP to $336, a lot of that came on the back of commercial payers. And just to address the other point, yes, it will be stable.

John Aballi

Hey, Mark, good morning. You also asked the question around impact relative to the new markers that we’re launching here later this year, I believe. And so, the methodology for those new markers is flow cytometry-based which as you know, we’re highly proficient at offering those complex tests, and it’ll be three markers We haven’t broken out financially how it’s going to contribute to the organization because we’re still honing in on that launch date. It’s not currently factored into the guidance either.

Mark Massaro

Okay. And the gross margins of 59% in the quarter came in well above our expectations. Kamal, how should we think about gross margin trajectory in 2024, recognizing that you are awfully close to your 60% gross margin target?

Kamal Adawi

Sure. So, one thing to always keep in mind with our gross margins is we have had seasonality with them that has been seen year after year. And while I’m very happy with our 59% gross margin in Q4, what we usually see going into the next year is a lower gross margin in Q1, and then we increase our gross margin in each quarter. Now, this year we’re doing something very similar to what we did in 2023, which is holding claims. By holding claims, that will reduce some of the fluctuations you see going from Q1 to Q2. We should see more stability in our gross margin between quarters because that fluctuation from the deductible resetting won’t have as great of an impact on the business. And we are very near – we are very close to our near-term goal of 60% gross margins. So, I’m very pleased with the progress we’re making there.

Mark Massaro

Okay. And then last question for me, the 2024 revenue guidance of $54 million is about 3% above 2023 levels. Can you maybe parse out what the mix will look like between volumes and ASP? I would expect ASP to be the focus, but do you also think you can grow volumes in 2024?

John Aballi

Hey, Mark, I’ll start off here. From our perspective, 2024 is really an execution year. We’ve set everything up in 2023, or at least did a lot of the heavy lifting in 2023 to make the strategic shifts that we needed to. And what that results in from our perspective is – the most sensitive lever being ASP improvement. So, our growth will be ASP-driven, but we do expect building back our volume over the course of the year, and we’re kind of looking at it as you had the back half of 2023. You had a run rate for volume. You’ve seen now consecutive quarters kind of in the low 30,000 level in terms of AVISE CTD units. And so, we’re building back from that level. We’re encouraged by what we’ve seen here in Q1 where we sit today in the quarter, but ASP is going to be the driver of growth there.

Mark Massaro

Got it. All right guys, thanks for the time.

Operator

Our next question is from the line of Kyle Mikson with Canaccord Genuity. Please proceed with your questions.

Kyle Mikson

Hey, thanks. Congrats on the year. So, just on that last point there, John, when you think about the below 30,000 like level here, building back from that, I mean, how well above that can we get to over the course of 2024? Can we get to like close to 40,000 tests per quarter possibly? Just how to – a lot of this is like kind of ASP versus volume, right? So, just trying to parse it out is important. So, would love to hear your additional commentary if possible. Thanks.

John Aballi

Yes. Morning, Kyle. Thanks for joining the call and appreciate the question. From our perspective, if you were to model 40,000 tests per year on a quarterly basis, 40,000 tests on a quarterly basis, you would have to model a significant decline in the ASP, and that is not consistent with what we’re achieving or our progress. So, from our perspective, we expect the ASP, the trailing 12-month ASP, mind you, to continue to increase throughout the year. That’s an inherently difficult metric to forecast progress on. Understanding when you’re going to have specific payer traction and when that cash actually hits the door, is somewhat challenging. And so, we’ve said, look at a 12-month – trailing 12-month number, smooth out some of that accounting variability, and we expect a growth rate there which will lead you into that $54 million overall revenue number. That’s a number we feel comfortable with right now knowing how we’re progressing. And so, that’s about the level of detail that we’re able to provide at this point. But I would not model a decline in ASP. That’s not consistent with our strategic approach.

Kyle Mikson

Okay. That was helpful. And then Kamal on like cash burn and then cash collections for first on like prior period collections, I know you had some of that in 2023. Is there any way you could kind of parse that out and help us understand the apples-to-apples comparison with the guidance here? because as you alluded to before, the growth year-over-year is not like robust, I guess, even though underlying strengths, like it’s clear. So, that’d be helpful. And then with cash, it just – it sounds like the cadence is similar to 2023 as – like, it’ll be similar to 2023 in 2024. Does that mean that like the first half of the year cash burn is going to be in line with like the full year burn kind of? Does that make sense? Just, I don’t know. Just kind of parse these things out for us.

Kamal Adawi

Sure. Thanks for the question, Kyle. So, let me address the prior period collections first. Full-year 2023, our prior period collections were around $5 million. We’re very pleased with the progress we made there. The revenue cycle management team made great strides in improving the processes, and it was a big driver for our accomplishments in 2023. So, very happy with that. Now, trying to forecast prior period collections or ASP in general is very challenging, but what I can tell you with how prior period collections should be thought about for 2024 is, while we made great strides in improving the processes, one of the things we’re going to see there is improved time to collect on some of these older tests that weren’t in AR or that were older than 12 months. So, we believe we made good progress there and we’ll see – we expect to see some additional prior period collections at the first half of the year, but by the back half of the year, I don’t think it’s going to be material or be a discussion point because I think revenue cycle management will have caught up by that point. Now, to address your second point on cash, we ended the year with $36.5 million, and I’m very pleased with the progress we’ve made in terms of reducing our burn and being very focused on our cash. We will see what we saw in 2023 with cash and AR offsetting during the year. So, by holding claims, we will see our cash balance drop and our AR increase and then offset towards the end of the year. I think what you saw in Q4 of this year is exactly what we tried to signal all year in terms of this should offset by end of year. So, I would expect to see that same cadence in 2024 with AR and cash balance.

Kyle Mikson

Right. Okay. That’s helpful. Kamal, thanks for that. And the final one for John on the three new T cell markers launched in 4Q of this year, that sounds exciting. I just wonder where those came from. The companies had partnerships with health systems and academic labs and even like biopharma companies over the time. So, just was wondering if the markers came from them or were those internally developed?

John Aballi

That’s a good question, Kyle, and if you’ll permit just a little bit of extra detail on them. First of all, these markers are going to be a huge benefit to patients and the clinicians who manage these patients, if you leverage the AVISE test. With our test, we anticipate identifying up to 50% of patients with SLE who would otherwise test negative by traditional biomarker testing. I think that’s a metric that should really resonate with clinicians. Certainly, with patients who have had long journeys in their diagnostic odyssey, it’s a dramatic improvement. We’re very proud to bring these to market. We know that much earlier diagnosis of these conditions can impact patient outcome. And so, we’re excited to contribute to improved care in this way. In terms of financial performance for our company, as I said, these are not included in our guidance as we lock down a launch date, but it’s going to be materially impactful to our organization. These markers we had license to out of Allegheny. We have a longstanding relationship and collaboration with that organization. It’s been very fruitful with the physician researchers there. We have quite a bit of ongoing research that occurs, but we’ve had license to them for a couple of years now, and we had worked on an abstract over the last 12 to 18 months, had that published at the most recent ACR meeting, and are just very excited about the results and the prospect of bringing these markers to patients. So, hopefully, that gives you a little sense of where they were. They’ve been licensed to the organization for a couple of years, but we had a heightened focus on AVISE CTD, and it really brought some of these opportunities to light over the last year.

Kyle Mikson

Yes, that was great. Allegheny makes sense. Just actually a follow-up. So, they’re kind of compatible to CB comp technology or is it like – it’s like incremental to that?

John Aballi

So, there are three individual analytes. One of them is cell-bound complement as it pertains to T cell. So, right now, our AVISE CTD offering measures cell-bound complement on the erythrocytes, along with B cells. This would be adding the T-cell component, but then additionally it’s looking at cell-bound IgG and IgM antibodies. And that’s a unique aspect of this disease as well, specifically SLE. So, you’re right in talking about cell-bound complement, but two additional markers are specific antibodies.

Kyle Mikson

Okay. Yes, that sounds great. Thanks guys. Appreciate the time.

Operator

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

Dan Brennan

Thank you. Congrats on the quarter. Maybe could you just walk through, we haven’t plugged all the numbers in yet, but just when we think about the burn for the year, we walk through the assumptions you’ve laid out so far, could you just give us a sense of kind of what’s implied for the cash burn for the year?

Kamal Adawi

So, we provided the adjusted EBITDA number for 2024. We believe it will be better than negative $20 million. Some of the things to think about is of where we came in at in 2023 with adjusted EBITDA of negative $17.1 million. While we’re continuing to make improvements on ASP, I do want to recall the $5 million in prior period collections that we had in 2023 that were fantastic to the business. And when it’s prior period collections, it 100% flows down to the bottom line. I don’t anticipate to see the same level of prior period collections in 2024.

Dan Brennan

Got it. And is there commentary that you’ve got $75 million in revs and 60% gross margin, which is a target to turn fee cashflow positive. I know you said – I believe you said cash on the balance sheet, the $37.5 million, gets you into 2026, or is the implication – do you think the 37 – or do you think the current cash balance will actually get you to that? Or excuse me, $36.5 million, will that get you to free cashflow positivity?

Kamal Adawi

A good question, Dan. We haven’t connected the two externally in a public forum. What we’ve worked to do is as the business performance has improved and we’ve seen the runway extend, we’ve worked to communicate that consistently. So, previously we had said we had cash well into 2025. Now, we’ve extended that projection into 2026. We haven’t connected the two. We’re highly dependent on improvements in ASP, right? The slope of our progress for ASP gains will really govern our pace at which we achieve cash flow positivity. So, that’s the connection there. Likely need to get to an ASP around the mid to high 400s in order for that to materialize. We’re making meaningful progress. You saw that over this year. We’ve pointed to a trailing 12-month number, but the quarterly progress is very positive as well. So, that’s how we look at it.

Dan Brennan

Got it. And then a final one just on sales headcount, can you just remind us kind of where are we today? Is that number stable? And just give us a sense of where you are with like calling accounts to focus on profitable accounts versus beginning to be at the point where, I know you talked about like most of the year, this year is still ASP accretion for the guide, but just where are you like in the field towards seeing maybe that restrictive nature focusing on profitable accounts flip towards being able to grow volumes again?

John Aballi

So, when it – if you take a look at it, when it really comes down to it – over 2023, we really changed our business. And I think at the core of it, the way we think about it is the insurer is a customer of ours, and there are some things that they require which can be burdensome for the ordering physician and therefore impact their desire to partner with us in patient care. So, the superior performance of AVISE CTD test is still seen by around 2,400 clinicians. That’s our year-end ordering physician count. We just need to work with them to satisfy the insurer needs and in a way which doesn’t overly complicate or burden their clinical practice. That’s our goal. That’s what our field-based team is working on. We’re no different, as healthcare costs are increasing, those of us with fixed pricing are getting squeezed, and the practicing clinician is seeing the exact same scenario. What we’re asking of them, additional medical records, more information on the requisition, better documentation of the clinical utility of the test and how it’s being used in patient care, they don’t get reimbursed for any of that. And so, it’s increasing their operating costs. And with rising wages, this is not an insignificant ask, but the way we see it, it’s a requirement of doing business in this space. It’s a requirement of offering proprietary testing. We just need to get good at it as a business and in developing processes with each of our customers to satisfy insurer requests. That’s what we mean by building back over time. We saw ordering trends stabilize in Q4 within our physician base. We’ve seen it building back here in Q1. And so, from our standpoint, we still have 40 territories spread throughout the continental US, and that’s likely to not change here in the near-term. We continue to monitor on a per territory basis which territories are at least covering the cost of the sales rep breaking even, and those which are materially higher that we should split. We’ve done at least one analysis this past year. We look at it as kind of a biannual thing where we review each of our territories from a profitability standpoint, take a look at six-month trends, and then we’ll adjust. But for now, 40 territories is the right footprint for us and will be likely for a portion of this year.

Dan Brennan

Great. Thank you, John.

Operator

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

Ross Osborn

Hey guys, congrats on progress. So, maybe just one for me at this point. It sounds like ASP is going to be the biggest driver to achieving EBITDA breakeven, but would be curious to hear your thoughts about OpeX cadence for this year. Is there any chance we should expect leverage on the SG&A line?

Kamal Adawi

So, Ross, the way that I’m looking at OpeX is there’s no major commercial expansion. Similar to the increases we’ve had in the past, I wouldn’t anticipate anything like that. Right now, it’s just us managing against inflationary increases on the SG&A lines.

Ross Osborn

Okay, great. Thank you.

Operator

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

Andrew Brackmann

Hey guys, good morning. Thanks for taking the questions. Maybe on the new markers here, can you maybe just talk about some of the specific steps that are needed to actually include that in the test here in the back half of the year? And I guess how should we be thinking about investment in the further study to really highlight that benefit that these might be able to provide to patients? Thanks.

John Aballi

Hey, Andrew. Good morning. Great question. Appreciate the opportunity to expand. So, these are lab-developed tests, meaning there’s not IVD, FDA-approved kits available. We’re validating these analytically as well as clinically in our lab and running those experiments. We’ve already performed an initial clinical validation. We have the assay up and running in our research laboratory. We’re moving it and getting it clear ready. And so, some of those aspects require really getting it to a point where it operates at scale. So, better processes around controls. We manufacture our own controls, for example, better processes around batching, workflow. There are some IT and software changes which really need to be made to handle it at the demand level we expect here later this year. And so, it’s mostly operational at this point as opposed to technical feasibility, and we’re well past that stage, which is a big reason why we’re talking about it externally. And from a clinical validation standpoint, we have an abstract out and we’re working on a formal publication likely to come later this year as well. So, the initial steps have been taken. We’re very confident with the performance of these markers. We have the appropriate supplier agreements and everything in place so that when we do ultimately go live, we’re in good shape. Another key component to this, when you bring novel biomarkers to clinical practice, there’s a huge educational burden required. And so, our commercial teams have been preparing actually for the last several months in this regard, a lot of planning in terms of what materials will be needed, quite a bit of voice of customer, how do we actually present the results in a manner which is easy to digest. Clinicians are busy, but also which allows them to act quickly. So, most of that has been completed. It’s executing on it. So, a lot of the planning phase is done. There’s still caveats to that, but quite a bit as that of that is done. And then we just need to execute. So, we’ll have to actually complete our formal CLIA validations on the analytical side. We’ll get our publication out. We’ll refine our training of our entire field-based team, and then we hope to launch sometime late into Q4. So, that’s really what’s left. And like I said, from a risk standpoint, the way we view it as a technical risk of the assay working or panning out from a clinical standpoint, we’re past that in our expectations.

Andrew Brackmann

Perfect. And then maybe just switching gears, going back to some of the commercial activities, John, that you mentioned around sort of hurdles or requirements to really do business in this arena, can you maybe just sort of talk about some of the specific tactics that your team might be able to deploy to either incentivize that behavior from physicians to allow them to gather that data or sort of reduce that burden for them? Thanks.

John Aballi

Yes, it all comes down to reducing barriers. Obviously, you have to understand your practices at a very deep level to understand where the pain points are. I think a big part of change management is really explaining the why behind those changes. And to be honest with you, a lot of clinicians don’t really understand the revenue cycle side, what’s being asked by insurers when you’re dealing with proprietary markers and having to prove clinical utility of tests or tools. And so, explaining that to them takes time. Some people want to listen, some people don’t. We try very hard not to make our problems our customers’ problems. That’s pretty basic business tenet. But from our perspective, when you’re able to explain the why, a lot more downstream goes smoothly, right? You get the buy-in. So, we worked hard to set ourselves up in that regard. We’re very transparent with our internal team, and that leads to transparency externally. And so, as we work through some of that explanation, then it comes down to execution. And what I mean by that is, each practice is different. Some have – in some cases, the phlebotomist handles most of the test processing within a clinician’s office. In some cases, it’s front office staff. In others, it’s nurses, and in some it’s the actual clinician. So, you can’t have a one size fits all approach to this. You have to tailor it into each additional – into each practice. And so, there’s some customization of processes there, but that makes it easier on the actual clinician. Also, when we’re explaining the why, some of this is training on what insurers are actually looking for. Insurers are really looking for was this test – what was the presentation of the patient which justified ordering of the test, and then how was the test used, and how did patient management change after the test was ordered and results received? So, it all comes down to documentation. And unfortunately, that’s – yes, that can be a bottleneck for some practices. And so, explaining that, talking through exactly some of the feedback we get from insurers has proven helpful, but a lot of this takes time, right? And it’s a cyclical feedback loop, meaning we work with different clinicians. We set expectations. We help them understand the why, and then when we put it in practice, that’s version one, and we ultimately have to get us to a successful version. This may even involve them getting on the line and partnering with us in some of the appeals process. We’ve had that happen, and that’s ultimately part of our goal where a clinician voices their perspective on the utility of the test in their practice. So, that’s really what it comes down to. Quite a bit of change in the office. It’s a different experience. It’s more akin to, I guess, what some of the oncology testing is doing. But clinicians, when they see the clinical value of the test, they’re very willing to do this. It’s just, can you make it easy on my staff? I can’t afford to spend an hour of their day completing test requisitions or pulling medical records or this type of thing. And so, it’s a utilization tactic by the insurer, but we’re working to satisfy it. As I said, we view them as a customer.

Andrew Brackmann

That’s great color. Thanks, guys.

Operator

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

John Aballi

Great. Thanks. 2023 has gone by quick, was an exciting year, and I’m very proud of the progress we’ve made. We’re working towards a more profitable business and we’re well on our way. I believe we have the right strategy, the right efforts, and the appropriate resources to transform our organization. Thanks for your interest in Exagen and for joining the call today.

Operator

This concludes today’s conference. You may disconnect your lines at this time, and thank you for your participation.