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Exagen Inc
NASDAQ:XGN

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Exagen Inc
NASDAQ:XGN
Watchlist
Price: 1.91 USD 8.52% Market Closed
Updated: May 16, 2024

Earnings Call Transcript

Earnings Call Transcript
2023-Q2

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Operator

Greetings. Welcome to the Exagen Inc. Second Quarter 2023 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. At this time, I would like to hand the call over to Ryan Douglas of Investor Relations. Thank you. You may begin.

R
Ryan Douglas
executive

Good morning, and thank you for joining us. Earlier today, Exagen Inc. released financial results for the quarter ended June 30, 2023. The release is currently available on the company's website at www.exagen.com. John Aballi, President and Chief Executive Officer; 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, and without limitation, statements regarding our business strategy and future financial and operating performance, including guidance for the quarter, 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, 2022, and any subsequent filings. The information provided in this conference call speaks only to the live broadcast today, August 7, 2023. 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.

J
John Aballi
executive

Thanks, Ryan, and thank you to everyone joining the call today, I'll discuss our second quarter results and provide updates on our revenue cycle initiatives, including our path to profitability. I'll then turn over the call to Kamal, our CFO, for details on our financial performance. Our strategy to prioritize and focus on AVISE CTD has resulted in another strong quarter with over 37,000 AVISE CTD tests delivered and total revenues of $14.1 million. As a reminder, we've made substantial changes to the structure and size of our sales team, and we believe that our Q2 performance is testament to the fact that we've continued to serve the rheumatology community in a highly effective manner. I'm encouraged to see consecutive quarterly growth in volume as we make operational improvements to our business, but this also reinforces the strategic decisions we made at the end of last year.

Exagen has significant opportunity ahead, and we're really starting to get on track as a team. It's exciting to see our progress reflected in the performance of the company this quarter. Our revenue for the second quarter was reflective of the strong testing demand and volume delivered in Q2, but also a result of improved cash collections from testing performed in prior quarters. We continue to focus heavily on our revenue cycle operations and have made major strides in Q2 to improve our processes, which I'll detail shortly. We expect to see incremental improvement in ASP as we move into early 2024, but we believe these early improvements in cash collections are a positive sign. Overall, we're seeing positive momentum in our operations and our efforts to achieve profitability continue to progress.

One of the key metrics where we saw improvement quarter-over-quarter was our trailing twelve-month ASP, which increased to $320 from $279. The increase in Q2 was aided by timing of cash collections on claims from prior periods, which we don't necessarily expect to recur each quarter. However, this was nonetheless a positive development reflected in the improvement in ASP. In general, we're beginning to trend in the right direction, but expect the bulk of our efforts to materialize into 2024. As we conveyed in Q1, we held claims to give ourselves time to optimize our appeal process, including an effort to increase the overall volume, quality and persistence of appeals. To give some color on the extent of our efforts to date, we brought in new leadership to this area of our business. We've worked with a technical rider to revise all appeal letters sent to payers on denied claims. We've restructured the appeals process with our internal team, redefining roles and responsibilities for every person involved in the process.

We've worked with our clients to improve the clinical notes they draft on each patient to better communicate the rationale for ordering and utilizing AVISE. We've worked to improve the process for exchanging these progress notes with our team to lessen the burden on our customer staff. We brought another personnel to increase the outbound calls to insurance companies, allowing us to keep better track of our appeal status. We strengthened the documentation around test ordering and the list continues. These efforts have been a substantial adjustment compared to what we were doing even 6 months ago, and we're still making progress to execute efficiently with these changes. All this requires communication and resetting of expectations with our customers in a manner which minimizes disruption and reinforces the value they've seen with AVISE testing for the last 12 years.

We continue to focus on achieving a profitable business. We refinanced our loan this quarter, which included a principal payment of $10 million. Our changes to revenue cycle management increased our accounts receivable by $6.9 million. Excluding these 2 items, our cash decreased $3.8 million in the second quarter. We are making progress in all areas of the company to operate as a leaner, more effective organization and the team at Exagen is striving to deliver the best service in the industry with a markedly improved cost structure. Additionally, we continue to expect our annual R&D expenses to approach $6 million, and therefore, our Q2 performance was aided by the timing of some of these expected expenses.

As an ancillary item, we recently reached an agreement in principle with the Department of Justice to settle an investigation that was initiated in February of 2022. This investigation was related to conduct that occurred in 2014 and 2015. We agreed in principle to make a settlement payment with associated fees of approximately $700,000 and admitted to certain facts, although we did not conceive liability. The DOJ will not require an outside compliance monitor to oversee our operations going forward.

The definitive settlement agreement is subject to further` negotiations, but ultimately, we look forward to putting this issue behind us so we can continue to focus on operating the business.

In closing, it's rewarding to see another quarter where our organizational performance is trending in the right direction. This is a testament to the hard work of the Exagen team and the value AVISE testing provides to the rheumatology community. I'm very encouraged by our recent performance, knowing that we continue to improve in many areas and have yet to see the results from several ongoing efforts.

Before I hand the call over to Kamal, I'd like to note that at our annual meeting this past quarter, Jim Tolles retired as a member of the Exagen Board of Directors. Jim had been a Director on the Board for 9 years and a vital member of the team. I want to thank Jim for his guidance and support to me personally. Jim has been a strong supporter of Exagen throughout much of the company's history, and we wish him well. Additionally, I'd like to extend a warm welcome to Paul Kim, the newest member of our Board. Paul joins us with vast business and leadership experience and currently serves as the CFO of Fulgent Genetics, where he played a pivotal role in growing the company into a successful and profitable business. I'll now turn the call over to Kamal.

K
Kamal Adawi
executive

Thank you, John, and Good morning, everyone. For Q2 2023, total revenues were $14.1 million compared with $11.2 million in Q1 of 2023 and $7.6 million in the second quarter of 2022. As a reminder, our year-over-year comparisons in 2022, payments from Medicare were delayed from Q2 to Q3. Sequential quarter growth in revenue was driven primarily by an increase in ASP. The increase in ASP was a result of improved collections from prior quarters dating back to Q1 2022, mostly due to greater-than-expected cash collections. Testing volumes for buying CTD were record 37,749. Other testing revenue was $1.6 million in the second quarter of 2023 compared with $1.4 million in the first quarter of 2023 and $1.7 million in the second quarter of 2022. Cost of revenue were $5.8 million in Q2, resulting in a total gross margin of 58.7% compared to 47.2% in Q1 of 2023 and 20.1% in the second quarter of 2022. The increase in gross margin percentage from the first quarter was primarily due to an increase in rural rates from improved collections in prior periods.

Operating expenses were $19.1 million in the second quarter of 2023 compared with $21.7 million in the second quarter of 2022, primarily driven by a decrease in employee-related expenses due to the reduction in force in early December 2022. For the second quarter of 2023, our net loss was $5 million compared with a net loss of $7.7 million for the first quarter of 2023 and $14.7 million for the second quarter of 2022. As a reminder, we refinanced our debt on April 28, which included a principal prepayment of $10 million. The refinance was through our existing lender and the current balance of the loan is $18.1 million. The terms of the agreement include a floating interest rate, which is a greater of 10% or prime plus 2%, resetting the interest-only period to 3-years, the implementation of a new management plan and improved covenants.

Cash and cash equivalents as of June 30, 2023, were approximately $31.5 million. As John mentioned, with our revenue cycle management strategy, the claims held in Q1 and Q2 contributed to the AR balance increasing to $16.2 million, which is offset by a lower cash balance. Overall, the company is performing better operationally than we were even a few quarters ago, and we're seeing to result in our key metrics. As you heard from John, excluding the loan principal repayment and changes in AR, this resulted in a decrease in our cash balance of $3.8 million in the second quarter. I'm very proud of the team and the changes we have implemented as we are off to a great start in our path to profitability.

Our cost of revenue are lower, our operations are much more efficient and all departments have goals that are aligned across the organization and continue to drive improved operations. Not to get lost in all the numbers, but just as important is the culture of the organization. I originally joined the company almost 10-years ago, and the culture is stronger than I've ever seen, which is reinforced by a decrease in our trailing twelve-month voluntary turnover rate. The rate has decreased 36% from the end of 2022 to June 30th.

Turning to guidance. Some of the changes in revenue cycle management that John mentioned will have an impact on future quarters. We're modelling a softening in volume in Q3 due to changes in revenue cycle optimization, but are anticipating the lower volume to begin to be offset by higher ASPs in 2024. For Q3, we are providing revenue guidance in the range of $10 million to $10.5 million. We will now open the call for questions.

Operator

Thank you. We will now be conducting a Question-and-Answer Session. One moment, please, will be pulled for your questions. Our first questions come from the line of Daniel Brennan with TD Cowen. Please, proceed with your question.

D
Daniel Brennan
analyst

Great, thanks. Thanks for taking my questions. Congrats on the quarter. Maybe just a couple, maybe just in terms of the benefit this quarter that you had from past collections, can you just quantify kind of what that was? And are you expecting any more benefit in the back half of the year?

K
Kamal Adawi
executive

Dan, thanks for the question. Yes, to quantify the prior year period collections that we're received in Q2 of '23, but mainly took place in the prior year. It was just under $2 million. This is a very positive impact -- but I view it as onetime. It's very tough to quantify if this is going to occur again. So, this comes from mainly 2022, and sometimes there are payments that take up to a year-to-year received. But I wouldn't anticipate it to be as large as what we just saw for '22 in future quarters.

D
Daniel Brennan
analyst

Great, and then on the burn in the quarter, so the way I understand it is, I guess, when you net out some of the changes that you had there, it sounds like you're basically saying your underlying cash burn was $3.8 million. If that's correct, then what level of burn, which is a nice step down, obviously, from what you guys have been having? What level of burn should we be expecting in the back half of the year? And with the impact on the accounts receivables that you highlighted, is that going to stop? So, should we see that kind of normalize going forward?

J
John Aballi
executive

Good morning, Dan. This is John. So, here's kind of the way we think about the cash burn in general, if I can open up the question a little bit more broadly. So, we burned almost $40 million of cash or an average of just over $9 million of cash per quarter in 2022. So far here in 2023, looking at the change in cash, as you mentioned, accounting for the AR as well as our debt principal payment we burned, approximately $11 million operating the company these past 2 quarters, and that was driven largely by some of the improvements we made just to recap. We've had the reduction in force of 42 individuals at the end of Q4.

That was a substantial cost savings. We've completed the evaluation of our R&D pipeline. We've set up criteria to pursue what we consider real business opportunities. These also strive to ensure financial success of the projects we're working to develop. We've worked to reduce the cost of our internal operations, and we've seen a reduction in our COGS as well. You see that with a similar overall COGS expense yet an increase in volume year-over-year. We've created an awareness and accountability at the company level from a budgeting standpoint. That's been one of the key things I've worked to implement is transparency into the expenses that we're incurring as a business all the way throughout the organization, especially at the department head level, and then everyone has generally bought into our efforts to reduce costs.

I mean, Kamal spoke to it a little bit about the culture. It's certainly a team effort, but it's embraced that way. So, we intentionally held claims in the first part of the year because we have the cash to do so and because we are working to improve our revenue cycle operations. I gave the details on prior quarters, but this was a huge undertaking and a significant opportunity for us. We began releasing these claims at the end of the quarter, and this will obviously slow the pace of cash burn going forward is how we look at it. I'll let Kamal maybe speak a little bit more on some of the specifics, but I wanted to give you our view here. We're ahead of schedule with the strategy we've put in place very positive from our standpoint.

The success we're having in reducing the cash use for operations has come down pretty substantially dramatic changes relative to where we were really even 6-months ago. Our AR balance has increased, as we said, about $10 million here in 2023. It gives a sense of the cash we expect to collect over the next several months. That should be weighed in as well considering our cash balance. But ultimately, we're always looking for ways to improve the organization. So, I'll let Kamal, maybe speak a little bit to the cash burn for future quarters and how we're thinking about that, too.

K
Kamal Adawi
executive

Yes. Thanks, John. So as John mentioned, AR was one of the items that we have to exclude to get the number of 3.8% and part of the reason why it increased from 3.2% to 6.9% for Q2 -- from Q1 to Q2 was we're holding all claims in Q2, where we started midway through the quarter in Q1, and so, AR cash burn going forward, we're providing guidance on a quarterly basis. I think sometimes there's quarters like we just had in Q2, where we have very positive impact from that, just under $2 million of additional collections received from prior periods into Q2, and it's tough to see the timing of some of these items that had a very positive impact on our gross margins.

We saw those increased to 58.7%. But again, very tough to project the timing of that, on the previous call, what I had mentioned on the Q1 earnings was we were at a $7 million cash burn in Q1, and we would see it gradually come down quarter after quarter. Now again, Q2 was very pleasant surprise with the additional selections, but that was then projected, and we did -- say that we would expect to see it come down slightly each quarter. That has not changed. That is still what we believe. We just had a really good Q2, but we believe that we're going to see those year-over-year improvements, but again starting at $7 million in Q1 and coming down from there.

D
Daniel Brennan
analyst

Great, thank you, and maybe just one last one, the 3Q volume guidance, obviously, you guys are on a journey here over the next couple of years. So not the loss on incremental, but why would the volumes go lower in 3Q given all the positive changes you guys have put in place? I know you've talked about on the last call, maybe some in the near-term could have some disruptions from the sales force realignment and then eventually, you begin to see the positive benefit. But is that the reason why you're guiding to sequentially lower volumes?

K
Kamal Adawi
executive

Certainly, so, to give a little extra color there, Dan. In Q1, Q2, we expected some impact from the reduction to the sales force. I think we detailed that extensively of the 42 individuals that were caught up in the reduction at the end of December. 1/3 of that was sales based, and so, we expected some impact to volume from reducing our U.S.-based footprint by about 30% or so. That was factored into our Q1 and Q2 guidance. It didn't happen. To be totally frank, and we've seen now multiple quarters that even with a more streamlined and condensed sales force, we're able to deliver, actually record growth here. So that's been very pleasant.

What we're factoring in, in Q3 are some changes to our revenue cycle operations, which are being translated to the customer. So just to give you a sense, one example, we've implemented a new billing policy this past quarter towards the end of this past quarter, which increases the cost sharing proportion for patients on our testing. The price of the AVISE test really hasn't changed in about a decade, and so, we're making those changes as we've telegraphed pretty clearly as we pursue profitable -- more profitable business, and so, these changes will improve the profitability of our portfolio, we anticipate but could have some near-term impact to volume, and so again, the magnitude and timing are always challenging to know ahead of time, but that's really what we factored into our Q3 guidance.

D
Daniel Brennan
analyst

Great. Thank you very much. I'll go back in the queue.

Operator

Our next questions come from the line of Mark Massaro with BTIG. Please, proceed with your questions.

M
Mark Massaro
analyst

Hi, guys. Thanks so much. Congrats on the strong revenue growth and a reduction in cash burn. I guess one for you, John. You've outlined a lot of changes to revenue cycle management. And certainly, I appreciate a lot of the color that you provided. I think it would be interesting to get your sense for like what inning do you think we're in with the changes to revenue cycle management? I'm just trying to determine how much continued improvement do you think we could see as we think about the business into 2024 and beyond.

J
John Aballi
executive

Great. Good morning, Mark. Thanks for joining the call. Thanks for the question. What inning we're in. I love the baseball analogy, especially given the season. So, from my standpoint, I think we're early innings, and the reason I say that is because we put a lot of work in terms of prepping, yes, that's what I've considered much of the first half of 2023 to be a lot of game planning there, and we're starting to put some of those efforts into play, really, right? So, the whole point of holding claims, just to give context to those comments, the whole point of holding claims was that we didn't trigger timely filing deadlines for our appeals process, and the core -- kind of a core tenet to our improvement in revenue cycle operations is improving the way we do appeals.

I think that's really where the over meets the road in terms of impact for us longer term, and so, I wanted to postpone as long as possible really, the timely filing deadline that would be associated with claim denials, and so, as we started to release those -- I expect for the claims that we are going to be denied on, I expect to start seeing those come in sometime around September-ish -- into October, and then that will be our first round of appeals. I've tried to detail this in the past, but just to refresh everyone, I think that we're going to have the opportunity to appeal somewhere around 3 times. That third level of appeal is often times associated with an external review by a specialist, and that's where we think really the value of the clinical data we've assembled and the value proposition will resonate most with that reviewer. So, from our standpoint, we've -- it's always been tough to nail down exact timing, but what we've tried to maintain consistency in communicating is -- sometime towards the end of this year and really into 2024, our growth will be a combination of both volume and ASP growth, our revenue growth that is, but it will be largely driven by ASP growth, and I think that, that's really the opportunity for the organization.

Again, I think that's the most sensitive lever we have to employ in growing this organization. We have substantial volume. We've shown we can continue to grow that volume with the current sales footprint, and we just need to pursue, I think, more profitable business from our standpoint. I've also detailed the list price of AVISE CTD is $1,650, and our Medicare rate for AVISE CTD is $1,067. You see our quarterly ASP was in the 330 range this quarter. Our trailing twelve-months is about 320. So, we're moving along in the right direction. I think they'll have some quarter-to-quarter gyrations. But generally, so far, I like the trajectory we're moving in, and I think we need to get to that $500, $600 range on an ASP level to really have some transform the organization. So hopefully, that gives you some context to timing and how we're thinking about it.

M
Mark Massaro
analyst

Okay. Great, and maybe one for Kamal. Kamal, if I strip out the nearly $2 million of one-time payments, you would have done around $12 million in Q2. You're guiding to 10.25% at the midpoint in Q3. How much of that sequential decrease would you think is related to the reduction in -- or the softening volumes in Q3 versus some of the collections from prior payments and/or other ASP dynamics?

K
Kamal Adawi
executive

Yes. Thanks for the question, Mark. So, our ASP, when you back out that approximately $2 million from prior period collections, is still increasing. We did see that improved collections from prior periods, does have an impact on current quarter ASP. So, we did have to adjust our accrual rate up for our tax performed in Q2. That's going to continue forward into Q3. So, I do anticipate our ASP to continue that improvement. So, it's going to be higher than what we saw in Q1. So, to answer your question, it's primarily going to be driven from a softening in volume and not being driven by the ASP some that have improved.

M
Mark Massaro
analyst

Yes. And just to confirm, I know Dan asked you in the prior question. Sometimes, obviously, there's summer seasonality in Q3. I know in prior years, there have been some quarters where volumes stepped down sequentially. But can you just maybe walk me through maybe how much of it is seasonality versus the reduction in force versus other factors?

J
John Aballi
executive

Certainly, Mark. I'll chime in here. In terms of seasonality, we had July 4 on a Tuesday, really aid away a good portion of the first week of July, and we're basically one month into Q3, right? So, where we're sitting at today is the quarter started off soft. It's a mix between the holidays -- the holiday impact that we believe. But we're also actually seeing our customer base a decent number of vacations. I know I've seen this with some of the airline reporting as well. International travel is up, especially with some of our key physicians.

We've had them go on a fairly extended international trips. We've conducted some of this research ourselves and surveyed some of our customers. From our standpoint, I have a lot of confidence that our team has executed the initial transition from a sales force restructuring standpoint very well, and I think we are a leaner organization, but we're delivering a very high level of service, and we're able to serve our key customers extremely well. So, I think how much is related to the reduction in force, I don't believe much. I believe the impact here is a mix of seasonality along with some of our transition on the billing policy side in pursuit of more profitable business. As I mentioned, you increased some of the patient cost sharing, you changed some of the prices of your tests, and while it's -- we don't believe it will impact the bulk of our business, it will impact a small amount. So that's kind of how we think about it.

M
Mark Massaro
analyst

Okay. That's it for me. Thanks for the questions.

Operator

Thank you. Our next questions come from the line of Andrew Brackmann with William Blair. Please, proceed with your questions.

D
Dustin Scaringe
analyst

This is Dustin on for Andrew. Maybe a little bit more about the sales or productivity, which I know you've touched on it in past questions, but maybe more so how should we expect that going forward? Is there really any impact that you still think might linger in the third and fourth quarters from a reduction in territory and people? And how exactly are you tracking those people maybe besides volume per rep?

J
John Aballi
executive

Hey Dustin, Good morning. Thanks for joining the call. Thanks for the question. So, I can speak to this from a qualitative standpoint, really to Q we've in on some of the things that we look at. In terms of performance as an organization, we take a look at orders per physician, we take a look at our physician base. In Q2, we had a growth in our physician base. We've had a growth in our higher ordering physicians. I think we have the overall outsized performance really across the board for all of our key metrics.

So, from that standpoint, when we take a look at whether it be driving new business, whether it be further penetration within existing business, I think through the rep transition, we've done a phenomenal job. The team has done a phenomenal job in executing well, and so, I think that we're very strong in that regard. Our reputation, our brand within the rheumatologic community is extremely strong, and the transition has had much less of an impact than we originally anticipated to be completely frank. So, from that standpoint, I think we are right on track. Really as we get into Q3, as I've tried to detail, it's a slightly different scenario, right? You're changing expectations with our customer base, and when the price of our test hasn't changed for 10-years, there's an ingrained expectation that's out there, and change management is always challenging, I think, especially when it comes to pricing and especially when it comes to physician behavior, so, our team is adept at this.

We've -- the company has a history of launching and expanding the product portfolio, and so, in terms of educating the physician base, I think we're very good at it. We prepared extremely well. We've generated quite a bit of new collateral that's gone out really to aid in explaining the change in the way to the physician. We've developed quite a bit of patient support material as well, and then we have a very compassionate team internally that's been educated us to have to communicate these changes and how to articulate them to patients as well as clinicians. So, I think we've done what we can to prepare and I've seen it first-hand. I was in the field actually in Houston and Saint Louis over the last couple of weeks, specifically for this reason, working to have conversations with some of our key clinicians, understand what the challenges of these changes mean for them in their practice, and the majority that I visited over -- I think it was 17 or 18 different clinicians over a couple of week period, and it was well received.

I mean once you explain the why, I think it was very positive. There are some use cases that will likely fall off better, more price sensitive, and so that's being taken account into our guide. But from a sales rep standpoint and from a preparation standpoint as an organization, I think we're right where we want to be, I think, handling it as best we can.

D
Dustin Scaringe
analyst

Got it, in the past, you've also talked about opportunities with large academic institutions. Just wondering how you guys are tracking in there in terms of ordering days and trends.

J
John Aballi
executive

Great question, so, we don't pull this out as an individual metric to report on, but I can give you a few highlights. We continue to do well with large academic institutions. I think we are strongest in the community-based practices where rheumatologists have kind of different pressures, if you will. They're trying to operate a more effective business on their own, and they're seeing upwards of 20 patients per day. So, time is of the essence in that context, in the academic setting or maybe even in the large institution setting, there's typically a combination of research demands along with clinical demands, and so there may be some more time for discussion, but also may be less patient flow and they tend to see some of the more severe patient cases, right?

Once you get referred to some of the academic institutions, your disease has likely progressed, you'd likely filtered through some of the community-based practices as well. But we've had -- over the first-half of this year, we had some significant wins. We've had a major system in San Diego actually take on our product, and we're -- we signed a contract with them to offer the AVISE test throughout their entire system, and then additionally, we've had North-western as well. That's a new contract for us, major academic institution that we've worked with. That was a multiyear effort to get that partnership established, and we're launching within that system here in Q3. So, I think we continue to do well. I think we serve the client bill, if you will, customer very well, and we have a very strong value proposition. We save the system money, and so, for those systems which are integrated within themselves and maintain a cost share component, it's a very attractive value proposition, not to mention the clinical benefit of the test. So, we continue to do well on both fronts. We have a team that's focused on this area, a team of individuals that their sole responsibilities to take a look at some of these large practices. There's quite a bit of bureaucracy. So, you have to have the skill set. You have to have the experience to work through these institutions, and so, we have a strong team that continues to do so, and we've seen some of those improvements. We just don't telegraph all of them on a regular basis or peel this part out. Mostly because I think when it comes down to it, what really matters is the performance of the organization as a whole and within the numbers, and so, we've queued people into the trailing twelve-month ASP. We've taken a look at overall revenue and then the cost per revenue, and so, we think that all of our efforts will culminate in improvements there and subsequently help us achieve a profitable organization.

D
Dustin Scaringe
analyst

Got it, good to see progress going on there, and just a last small one for us, any update on the adviser is LCD to mid last July?

J
John Aballi
executive

Sure. So, from -- just to level set everyone as well on the call. We obtained a proprietary PLA code for the AVISE Lupus testing, and it was granted in April of 2022. We went through the pricing procedure over the past 12-months or so, and pricing for AVISE Lupus was finalized in January of this year, and then we've maintained coverage as well as payment for 2022 and 2023 claims throughout that process. As part of this, Medicare had asked us to submit for and apply an LCD, we did so in September of last year. And we got acknowledgment at the time that it was a valid submission, and we are waiting for the next contractor's advisory committee meeting, CAC meeting to understand when a draft LCD will be published.

At that point in time, it will be approximately about a year before any Coverage document would be finalized and public comments would be welcomed throughout that approach. But for now, there's no statutory requirement for time lines, and we're just waiting on our local MAC, that's Noridian to hold this meeting and to push them all forward, so for now, no additional updates. We have a great working relationship with the Noridian team, and to date, they've given us no indication as to when that meeting will occur. So, we remain in the queue and exactly where we were almost a year ago at this time.

Operator

Thank you. Our next questions come from the line of Kyle Mikson with Canaccord. Please, proceed with your question.

K
Kyle Mikson
analyst

Yes. Hi guys, thank you for taking my question. Congratulations on great quarter. Can I take a stab of something here? So ACR Convergence is coming up in early mid-November or the fourth quarter. Aside from these RCM changes, don't like -- we saw 3Q guidance, we on the surface reflect any kind of air pocket, I guess, among docs leading up to ACR, and in the past, ACR actually impacted in the fourth quarter, but I just want to kind of ask the question around seasonality factors that we should be considering in the second half of the year.

J
John Aballi
executive

Certainly, thanks, Scott, for joining the call. Maybe I can share a little bit regarding guidance how we're thinking about it, with ACR direct factor. I think in general, just too directly answer your question. In general, it's part of it. ACR certainly pulls -- it's an annual meeting for the rheumatology community it pulls most of the rheumatology community out of their practice for approximately about a week. So, you lose 12th or 13th of the patient flow productivity through any given quarter, and it's occurring, I believe, in September is of this year, it's in San Diego actually local to us. So, we're excited for that meeting. It's a productive meeting where we certainly get to engage with our customers. But in terms of guidance, that wasn't necessarily one specific driving factor in the guidance. Overall, we're seeing very strong progress year-to-date in executing against our strategy, and I'm very encouraged by the results we're seeing this year. I hope that's coming across. We continue to change significant aspects of the business, and these changes can contribute to either a lack of visibility in the magnitude or timing or really both in terms of the ultimate impact to the business. So, we've been consistently communicating that there'll be some impact to our performance as we pursue more profitable business, and it's just challenging to know the exact timing and extent. Obviously, when you make a change to the billing policy and you start to increase some of the cost share component related to the patient, we think that, that is going to be a driving factor for some near-term impact, and that was really what we took into account when making this guidance. As I mentioned, we do still have what we believe is some outsized impact from vacations of physicians and -- but it's tough to exactly narrow in on proportionality there and quantify the magnitude of impact. We think we've done the best job we can with the information we have.

K
Kyle Mikson
analyst

Yes. Okay. That was great. Thanks for the turn. And then come on, on the gross margins, almost 60%, getting flashbacks to the gain agreement days with 100% margin. How should we think about the gross margins going forward? I mean obviously like tied to revenue? And if that's dipping in the sort of quarter and I guess fourth quarter, clearly, margins should decline from here. But I mean what's a good way to think about this? I mean like the high 50s is good, but should we expect the 450 or something like that going forward?

K
Kamal Adawi
executive

Yes. Thanks for the question, Kyle. So, in 2022, our or margin percent was 47%. Year-to-date, through the first 2 quarters of 2023, we're at 54%. Now keep in mind that $2 million or record $2 million that we've been talking about prior period collections, that does have an impact on the gross margin a lot of that occurred in 2022. So, if you back that out, that has about a 7% impact on year-to-date gross margins. So, I'm very pleased with how that has been performing. As John has touched on, the company has been very focused on capital profitability and just operating as a lean organization. That's true across the entire company, but it's definitely true in the last, and we're seeing a lot of improvements there, and they're doing a fantastic job of focusing on driving that gross margin percentage up.

Now -- we spoke about the goals of achieving 60% as an organization. We're trending in the right direction, and I feel confident that we're going to be up to achieve 60%. Now in terms of China guidance to that this year, we haven't guided on gross margin in the past. But I think that tells you, we should be seeing improvement quarter-over-quarter from how we're operating as an organization. Seasonality has always an impact for us. It's a positive impact as each quarter goes on because of the deductible reset at the start of the year. So, we should see higher gross margins as the year goes on. But like I said, we're trending in the right direction, and as a company, our goal is to achieve the target of 60%.

K
Kyle Mikson
analyst

Okay, thanks Kamal, and then I know John is kind of early to talk about the 24 strategic priorities. But as you evaluate this profitability, are you guys hoping to increase the sales force and the territory footprint, maybe like early next year. I guess could you just kind of walk through your thoughts on the expansion in the next 12-months to kind of drive that market penetration and the top line growth and everything.

J
John Aballi
executive

Great, thanks for the opportunity going into the detail here, Kyle. So, when we did a rightsizing of the sales force in December of this past year, our logic or rationale at the time we want to take a look at each of our territories, and on a per territory basis, see which of them covered at least the cost of the sales rep, where we're breaking even for having a field-based presence in that given territory. That was the question we tried to answer across the board, and for 23 territories, the answer was no, actually, a little bit more than that. What we've done now is from a footprint standpoint, but then this also carries into an expansion strategy is we've taken a look at which territories we're supplementing just at least the cost of the rep, and we're maintaining about 4 to 5 of them right now.

That's the same number as at the start of the year, and we're working to grow those territories so that they at least cover the cost of the rep, the idea here is it gives us an empirical approach to expansion where we can really see if it's the right territory, is the right individual for that area and it lets us change some of those variables in a more measured, meaningful way. But ultimately, it also lets us have great visibility on the cash required, the expense required to expand. So right now, it's about $1 million a year that we're supplementing the territory on a -- when you weighed against the cost of the rep, and so that's going to be our approach going forward.

As we have our, comp expansion territories or growth territories that over time will flip over into a profitable state, then we'll add a new growth territory, and that way, it will kind of be self-fulfilling and cyclical in that manner. So that's our approach. Whether that occurs in Q1, I hope so, to be honest with you. The -- but we have some -- we have convertibles that are really to figure out there, right? Again, is it the appropriate territory, what's the potential relative to the business that we have there? Is it the right individual? We have quite a few things to evaluate and are constantly working with. So as of right now, we feel very comfortable with the 40% that we have. We'll see when we have some sustained performance in some of those growth territories that flips them over to a profitable state, and then at that point, we'll add, we'll also be very clear in that communication.

K
Kyle Mikson
analyst

Perfect. That was great, John. I'll look there. Thanks. Appreciate the time.

Operator

Thank you. Our next questions come from the line of Ross Osborn with Cantor Fitzgerald. Please, proceed with your question.

R
Ross Osborn
analyst

Good morning. Congrats on the quarter. Just one for us, I would be curious to hear if there's any update on the pipeline with regard to nephritis, but if you can provide any more color on where you are in terms of time to market, thank you.

J
John Aballi
executive

Sure. Good morning, Ross, I got the first question. The second question was timing to market for those just to be clear.

R
Ross Osborn
analyst

Yes, that's correct. Thank you.

J
John Aballi
executive

Okay, great. Thanks for clarification. So, in terms of our R&D pipeline, in terms of what's occurred over the last 6-months, the key cornerstones when I joined the company were the RADAR program, which was a therapeutic selection in the context of for rheumatoid arthritis, along with the fibre biology diagnostic assay and then some therapeutic response assays in the interferon space as well. So, at the time, we took a pretty detailed approach to this. We -- I'm a big fan of setting up the criteria for success before conducting the evaluation, and so, we put this criteria in place, and we thought that if we could identify technologies that were kind of want proprietary in nature; 2, had an ability to demonstrate clinical utility that was -- we thought was realistic; 3, the had the ability to achieve value-based pricing.

We believe that you have to have some certainty in your reimbursement before launching a product. So, Medicare coverage was a fourth component here. Also, we want to develop products that meet customer needs, existing customer needs. So that was another component, and then lastly, really having fleshed out the guideline strategy, I think having inclusion in guidelines or at least a pathway to getting there is incredibly important when you're weighing whether or not to move forward with a given opportunity, and so, we put those in place as a way to evaluate the pipeline. It ultimately resulted in discontinuing quite a few of the projects that were in the existing pipeline. But we've rekindled some of those efforts in the context of really owning the Lupus patient journey.

That's kind of how we're doing it internally, and so, we have a program ongoing now to take a look at both diagnostic as well as therapeutic monitoring and disease activity in Lupus nephritis. So, this is the indication where you have inflammatory flare in the context of Lupus, but related to the kidney. It's potentially life-threatening, very significant consequences for the patient, and unfortunately, is detected oftentimes late stage when the kidney is -- has progressed quite a bit in the context of that inflammatory state. There's also therapeutic options on the market that are available. You have a couple of some pharma companies that are bid on the market for a little bit of time here. So we believe that's a pretty exciting opportunity we're pursuing.

We're also looking at Lupus in general from a disease activity standpoint. Right now, there's some clinical monogram that exist, but they're extremely cumbersome, very time consuming to execute are not done practically in the community setting and really understanding how the disease is progressing over time is essential to modulating therapy in this context. So exciting for us to develop something here, and I think we have some great initial data showing we can do so, and then there's a few other products that we're working on. What I've really committed to externally is talking about some of our pipeline products as we have meaningful development, not so much selling the future on the come. We're very excited about the potential for bio CTD and the ASP improvements that we believe will develop here over the next several quarters and well into 2024 into 2025.

So that's where a lot of our focus is, and opportunistically, we have some meaningful data, some scientific breakthroughs, if you will -- we'll disclose those. Right now, I've said I think all making more comments available externally once we have a clear path to commercialization within the 12- to 24-month time line, and right now, our current R&D pipeline doesn't have projects which fit that, but that doesn't mean that the current projects can't fall into that over time. I just need to gain a level of certainty and de-risking some of the -- either whether it be technical performance of the assay or in the reimbursement side before commenting on them. So that's kind of the conservatism we've taken in detailing our R&D pipeline. Hopefully, that helps Ross.

R
Ross Osborn
analyst

Thanks for the update. Congratulations again for the quarter.

J
John Aballi
executive

Thanks.

Operator

Thank you. There are no further questions at this time. I would now like to turn the floor back over to John Aballi for closing comments.

J
John Aballi
executive

Great. Q2 was another strong quarter where we continued to execute on our objectives and in pursuit of a profitable organization. We're making great progress, and I'm especially proud of the Exagen's team for navigating these changes effectively through this point. Thank you for your interest in Exagen, and we look forward to continuing to provide updates on our progress as we work to improve our organization. Thank you.

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