Exagen Inc.

Greetings, and welcome to the Exogen Inc. Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during this conference, please press star zero on your telephone keypad. And as a reminder, this conference is being recorded. And it is now my pleasure to introduce to you Ryan Douglas with Investor Relations. Thank you, Ryan. Please go ahead.

Good afternoon, and thank you for joining us. Earlier today, Exygen, Inc. released financial results for the quarter ended September 30th, 2023. The release is currently available on the company's website at www.exygen.com. John Ibali, President and Chief Executive Officer, and Kamala Dowie, Chief Financial Officer, will host this afternoon'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, Our current and future product offerings and reimbursement and coverage are based upon current estimates and various assumptions. These statements involve material risk 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 risk 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. 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 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 on the investor relations page of the company's website. The information provided in this conference call speaks only to the live broadcast today, November 13, 2023. Exogen disclaims any intention or obligation, except as required by law, to update or advise 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 Avali, President and CEO of Exygen.

Thanks, Ryan, and thanks to everyone joining. For today's call, I'll walk through our third quarter results, the significant progress we are seeing in improving our business, and provide updates on our overall progress to achieve profitability. I'll then turn the call over to our CFO, Kamal, for further details on our financial performance. To start, I'm extremely pleased with the results we are seeing from initiatives implemented this year. Our strategy of focusing on higher margin products and implementing changes that will allow us to expand margins is yielding results. We are doing all of this while paying rigorous attention to controlling costs. our performance has continued the trend of surpassing expectations, and we are well on pace to deliver record and growing advised CTD trailing 12-month ASP, record full-year revenue, and marked improvement in cash burn relative to last year. The team at Exogen has greatly improved the organization while continuing to serve rheumatologists throughout the US with the best testing available. Specifically highlighting a few key metrics, Our trailing 12-month ASP has reached an all-time high for advised CTD testing and increased from $279 at the start of the year to over $320 this past quarter, reflecting a $40 increase. This progress corresponds to third-quarter revenue of $13.4 million with gross margins of 57%. The increases we have seen in ASP over the past few quarters are the result of a more effective billing operation and improved cash collections. We've worked extremely hard to improve in this area, and the results are showing. Our gains in collections are from commercial payers, which is not easy to do, and a direct reflection of our ability to execute. To give an example, historically, accounts over a year old had a very low probability of being collected on. But with the improvements to our billing processes, we've been able to see improved collections on these older cases. In the third quarter, we were able to collect around $600,000 from tests that were completed and billed over a year ago. This momentum is just the start, and we expect to see continued growth in ASP throughout our 2024 performance. Our ability to demonstrate improvement in ASP while significantly reducing costs is validating our strategy. Our adjusted EBITDA for the first three quarters of 2022 reflected a negative $26.4 million. Here in 23, we've cut that in half to $13.2 million while delivering improved ASP revenue and volume for the same nine-month period. Improvements to ASP continue to be the most powerful tool we can utilize to achieve our goals, and we are delivering. I'd like to provide a few details on cash management for the organization, as we have seen significant collections this past month. Our accounts receivable balance at the end of September was $17 million, but has improved to approximately $11.6 million on October 31st. Correspondingly, our cash balance at the end of September was approximately $28 million and has increased to over $31 million at the end of October. We anticipate finishing 2023 with more than $30 million of cash on hand, effectively improving our cash balance from the end of Q2, as we've drawn down our AR exactly as we expected. When factoring our quarterly cash needs against our current cash balance, we estimate that we have sufficient cash on hand to execute on our current operating strategy into late 2025 or early 26. In the third quarter, we continued our strategy of implementing changes to our processes, which are expected to improve ASP in the future. And while I'm confident our team has made every effort to prepare and educate clients about these changes throughout the summer, we did experience a modest decline in test volume in the third quarter to 32,600 advised CTD tests. The decline was expected and was the driving factor in our guidance for Q3. We believe our decline in volume will be transient in the long run as we pursue more profitable business. It's important to recognize that not all testing volume aligns with our current strategy of improving ASP, and some of this loss is reflective of that. Additionally, when we analyze the change in ordering patterns, we've observed that the majority of the decline is reflected in reduced test orders on a per-physician basis and not tied to a significant contraction in the ordering physician base. Our team is diligently working to support customers through this transition and establish processes which best fit each customer's clinical workflow. We anticipate a return to prior volume levels in the back half of 2024 as we work through these changes. For clarity, we believe our Q4 volume will be the low point due to the inherent seasonality typically seen in our business this quarter and some lingering effect from our implemented changes, but building back from here as we head into the new year. Our strategy remains rooted in improving advised CTD ASP and the pursuit of more profitable business, which these changes have set us up to achieve. In regard to our R&D efforts, we recently achieved a significant milestone and are pleased to announce that we've entered into an exclusive license agreement with Johns Hopkins University to develop clinical tests leveraging novel biomarkers for lupus nephritis. This technology and invention is from the laboratory of Doctors Michelle Petrie and Andrea Fava. The opportunity in lupus nephritis meets our requirements for developing testing solutions to better serve our customers. When I speak to rheumatologists in the field, they have made it very clear that having access to biomarkers, which would aid in the management of SLE patients with kidney involvement, would provide significant utility to their practice. And given that approximately half of all SLE patients go on to develop some form of lupus nephritis, We believe this technology will be instrumental in enabling better patient outcomes. To hit on a few ancillary topics, with the recent announcement from the FDA, we are closely monitoring the proposed rules to regulate lab-developed tests, such as Advise CTD. We believe that multiple details need to be addressed with greater clarity and are waiting for the dust to settle in this regard. But we're familiar with the 510 route and believe that with our current level of supporting data, if ICTD would be well positioned to comply or come into compliance with the FDA's requirements and timelines should they come to fruition. Also, in October, we finalized our settlement with the Department of Justice for an investigation that was related to activities which have since been discontinued but occurred in 2014 and 2015. The agreed upon settlement was approximately $650,000 and we're pleased to put this issue behind us so we can continue to focus on operating the business. Kamal will now highlight the financial performance in greater detail.

Thank you, John, and good afternoon, everyone. For Q3 2023, total revenues were $13.4 million compared with $14.1 million in Q2 of 2023 and $14.7 million in the third quarter of 2022. As a reminder, for comparisons to prior year, Revenue in Q3 of 22 included $3.7 million of Medicare revenue from Q2 2022. Testing volumes for ViCTD were $32,618. Other testing revenue was $1.4 million in the third quarter of 2023 compared with $1.6 million in the second quarter of 2023 and $1.9 million in the third quarter of 2022. Cost of revenue were $5.7 million in Q3 resulting in a total gross margin of 57.4%, compared to 58.7% in Q2 of 2023 and 59.2% in the third quarter of 2022. Operating expenses were $18.5 million in the third quarter of 2023, compared with $22.5 million in the third quarter of 2022, primarily driven by a decrease in employer-related expenses due to the reduction in force in early December 2022. For the third quarter of 2023, our net loss was $5.4 million compared to a net loss of $8.1 million for the third quarter of 2022. As we focus on profitability, we look to provide a consistent financial metric to measure the company's performance and will now be providing adjusted EBITDA on a go-forward basis. Our adjusted EBITDA excludes stock comp expense since that's a large non-cash expense for the organization. Adjusted EBITDA was negative 3.6 million for Q3 2023, compared to negative 6.1 million for Q3 2022, and negative 13.9 million for the nine months ended September 30th, 2023, compared to negative 26.4 million during the same period in 2022. We're seeing remarkable improvements in our adjusted EBITDA over the past few quarters, and I fully expect to see the trend continue in 2024. Please refer to our earnings release issued earlier today for a reconciliation of adjusted EBITDA to net loss. Cash and cash equivalents as of September 30th, 2023 were $28.4 million. As we have previously communicated with our revenue cycle management strategy, the claims held in Q1 and Q2 contributed to the AR balance increasing to $16.2 million in the second quarter, The AR balance at the end of Q3 was $17 million, with the majority of the increase from Q2 to Q3 due to increases in our accrual rate driven by the success we have seen in increased collections. From late September and into Q4, we've seen our cash collections accelerate. To reiterate what John said, our AR balance decreased approximately $11.6 million on October 31st, which in turn increased our cash balance to $31.4 million, and I anticipate this trend to continue throughout the end of the year. We're seeing great results in our key metrics as we transform the business to a more profitable testing company. For full year 2023 revenue, we're providing guidance of at least $50 million, which will be a record annual revenue for the organization. We also believe that our adjusted EBITDA for 2023 will be around negative 20 million, and we expect adjusted EBITDA to improve in 2024. We will now open the call for questions.

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. And the first question comes from the line of Kyle Mixon with Canaccord Genuity. Please proceed with your question.

Hey, guys. Thanks for taking the questions. So on this volume decline that we're seeing sequentially happen, I just wanted to understand why that's going on here. It sounds like docs are ordering less tests, but the clinician base is the same, I guess, or is at least relatively stable, not declining. Why are rheumatologists ordering less tests, and how do you correct that? And then also, why do you think this will last so far into 2024? It wasn't quite clear on that. Thanks.

Great. Good afternoon, Kyle. Thanks for the question. So We've made it very clear that our top priority as an organization is profitability. And everything that we're doing is in pursuit of more profitable business. So we've changed a lot of things at the company as it pertains to working with us, including the individuals that customers interact with. We went through a change in our Salesforce team in December of last year. So even the folks that our individual clinicians interact with has adjusted the policies and that they know us by and interact with us on have fluctuated along with the actual service we provide. We've gotten better in many of these respects. But it has been changed. And I fully recognize that change is not easy for all folks, especially customers. And it has an impact on testing demand. So that's what we saw here in Q3. Again, fully expected. That's why we guided the way we did. These changes will improve our ASP significantly over time. Some of this is getting medical records on specific cases and using physician advocacy in pursuing appeals. And so having their partnership there requires a little bit more time on their side, but it is in pursuit of more profitable business. And I will just say that our team prepared extremely well to educate customers. Our marketing team created very clear materials. We worked very hard to explain the why we're doing this and align on the message across the organization. So as customers talk to our internal customer service, billing, or the actual field-based rep, they got a very clear, concise, aligned communication. We did launch the bulk of these changes in early Q3. And pretty quickly there, we recognized an impact to volume, but have since flattened out. We're building back. this quarter. We expect to build back in Q1. From our standpoint, Q4 would be the low point building back in Q1. We have a few major or minor holidays here in Q4 which impact this as well. It also corresponds to a lower number of lab days. We have our rheumatology national meeting this quarter. It's actually in San Diego, but it pulls a significant majority of the clinicians out of their practices for the full week. And so, you know, all of those things kind of mixed together are what's factoring into Q4 being the low point, building back in the first half of the year and returning to kind of those prior levels in the back half of the year. That's how we envision it right now. And I personally went into the field, I was in the field in July, August this month, and have two trips planned for early December to interact with our customers firsthand and to understand what are some of the challenges that people are facing with and being faced with and get that firsthand feedback from clinicians, specifically visiting some of our top customers. And the primary takeaway is clinicians do understand the changes and why and that we're just working through as an organization in a partnership. We're trying to figure out a way to optimize their clinical workflow to accommodate some of the things we need to be more effective on our billing and our ASP side. Again, we're seeing those improvements on the ASP side, so it's absolutely the right way to go. It just takes an adjustment period, and so how long does that adjustment period is not set in stone, but we envision it to be reflected in Q4 numbers and building back in Q1 early part of the year. We've already started to see this in many territories building back from where we were at the start of the quarter. So, especially when you look at some of the normalized weekly numbers. So, at least as it stands for me, I feel very confident that our growth in 24 will be a combination of both volume and ASP improvement as we've expected.

Okay. That was great, John. Thanks for all that. And then I want to ask the kind of the obvious question about the, you know, the guidance was 10 to 10.5 million for the quarter. You beat by, you know, 3 million, over 3 million. It's kind of a wild outperformance. It's, again, very good to see. Was there any, like, one-timers this quarter? I know that's kind of happened in the past. I think I heard something about maybe, like, 600,000 in prior period collections possibly, but anything significant this quarter? And then also, you know, just given that, I mean, is this gross margin number a good way to think about the run rate level going forward? Because, I mean, it's great to see, like, mid to high 50s. Just curious about, like, kind of the longer term.

Great. So combination of answers here, Kyle, to address all the points you brought up. Kamal hit some of the back half items. For me personally, the volume impact is a part of it. And as I mentioned, we expect that to be reflected in our Q4 numbers and then building back here in Q1. So that's part of that guide, certainly. We've articulated in the past, it's very difficult for us to forecast and certainly to project increases in ASP. We have shown an ability to drive consistent progress there over the course of this year, and we believe that will continue. But as we mentioned in the past, our conservative approach to this is to expect increases to expect that growth to be reflected kind of retroactively, right? So after we have the quarter, we're able to dive into what some of the factors there and the magnitude of that change. So while we do expect growth in ASP, it's difficult to forecast the exact amount, and that's reflected in the guide as well. Kamal can speak to a few of the other points. Thanks, John.

Kyle, I'll address your questions in regards to one time and the impact on gross margins. Historically, we've not had a lot of success on collecting on tests that were older than 12 months. And as John mentioned in the prepared remarks, we collected around 600,000 from tests that we had the AR written off because they were older than 12 months. Now, I don't want to call that one time, because this is the second quarter in a row that we've had this success with tests that have been written off. And that speaks volumes to the changes in billing and the strategies that we're executing on there, whether it's appeals, the medical records, the small increase in patient pay, we're seeing higher ASP on each test also. So we've seen the ASP come up, we've seen improved collections, and we've seen collections on things that were written off. Now, the impact on gross margin, we should have seen, you can argue, higher gross margins in the past because We had lower accrual rates that we've had to take up because the collections have been more successful this quarter. So we came in around 57%. If you back out that 600,000, yeah, you're in the low 50%. Low to mid 50s is where we have been year to date. So that is a good run rate or a good way to think about our gross margin percent.

Okay. Yeah, that was brilliant. Thank you so much for that. One last question for me. On the cash flow dynamics, great to see what happened after the quarter end, I guess. Really good to see that. It sounds like pretty positive commentary for 2024 as well. And you're providing the EBITDA metric now going forward too, so that's great. I was just wondering if you guys talk about the working capital and general cash collection versus burden trends in 2024 by the quarters. I just wanted to know if there's any seasonality

um when there could be like you know significant burn one quarter and then like a material maybe um like you know operating cash generation the next quarter kind of a thing just curious if there's anything you can kind of share on that well kyle i'll trust the networking capital comments you had in there um because obviously the biggest change we've seen this year was the uptick in ar and that's why we wanted to give more color on that with providing the AR balance on 1031, which was down $5.5 million from where we ended on September 30th in just one month. So that is trending in the right direction. But in terms of networking capital and the seasonality, yes, AR is likely something that we will see uptick during the year and decrease towards the end of the year. Okay, perfect. Thanks, Kamal. Thank you, guys.

And the next question comes from the line of Mark Mazzaro with BTIG. Please proceed with your question.

Hey, guys. Thank you for taking the questions. I wanted to start, John, I just wanted to clarify a point that you made in the prepared remarks that you expect Q4 volume to be the low point. I wanted to just clarify that you mean Q4 2023. And just help me understand this sort of bridge back to the back half of 2024 to return to more historical prior record volume levels.

Absolutely. Afternoon, Mark. Thanks for the question. So to your first point around timing of the impact regarding volume. So what we saw just as a reset here. So what we saw after we implemented changes mostly policy-based changes to the way we approach billing. And again, this is, to give you a flavor for this or a feel for this, this is our patient responsibility. This is the requirement of medical records, these types of things, so that we're more effective on the appeal side, et cetera. As we implemented those, we saw an immediate response reflected in orders per physician, not so much a contraction in the physician base, but just people are getting adjusted to the change. And as I mentioned earlier, working to establish processes within their clinic that keeps them functioning efficiently, but also meets our requirements. And so we saw that fairly immediately. In the summer, we also had a mix of some vacations with clinicians as well. And so by the end of the summer, we were getting a feel for what that CULT run rate would be. And we saw it basically flatten out. And here in Q4, as I mentioned, so If you assume that the effect we would have anticipated related to volume from these changes has been recognized or reflected in the business, then Q4 has a lower number of effective lab days. And that's really what's factoring into that and why we believe Q4 will be the low point for volume is that we've started to build back. And I've spoke with individual clinicians, with our field-based team, different territories, And that's the impression that we have across the organization, certainly, because that we are building back. But when you take a look at having Thanksgiving, Christmas, you have Veterans Day where we've got a week, a solid week of meetings here in San Diego with the American College of Rheumatology meeting occurring here. It pulls a significant amount of rheumatologists out of practice and into their society's week-long meeting. And so we see that reflected in volume as well. So the On a normalized basis, we have seasonality in Q4. We've seen this in prior years as well. And so that's why we call out Q4 as the low point volume-wise. And then building back from here, given that Q1 is a historically strong quarter for us, we've got a full slate of lab days and effective lab days at that. And we've already been working to build back and have that sentiment internally. That's the function, and you're exactly right. I meant 2023. Thanks for the opportunity to clarify that. So this quarter that we're in right now being the low point and then building back from here.

Perfect. Thank you for clarifying that. I know, I believe it was on the last earnings call, you talked about the potential to move a buy CTD into guidelines. I'd just be curious, You know, I recognize that that may not be a near-term initiative, but I was just curious if you had an update with respect to anything you're doing on the guideline front or, you know, how we should think about the opportunity going forward.

So, inclusion in guidelines would be a catalyst for us both from a payer side as well as adoption, right? Continue to push on both fronts. And we recognize it is a very valuable aspect. of a product and a differentiating aspect of that. So it's part of our strategy. When I came on board last year about this time, I placed a heightened focus on it, and we've laid out some very clear objectives, the first being get to know the people on the guidelines. I think once it starts there, then you get a great flow of feedback, and then you can actually make informed decisions, hopefully based on facts, to get included into guidelines so we've done that and we've been working throughout this year to establish those relationships this past quarter actually September we were included in in a new update on the Lucas lupus encyclopedia and this is a this is a book a publication it's a very thick book actually several hundred pages which is meant for both clinicians and patients. It's written by a clinician, Don Thomas. I'll just give you a feel for him in one second, Dr. Don Thomas. But we have five pages devoted to our testing, and it's under the heading of Specialized Testing Within Lupus. And specifically, it cites in there that there's no other testing worth mentioning. And so from our perspective, having noted inclusion in that publication, if you will, or that book, was a very important milestone for our company for a couple reasons. One, it specifically reviews the body of literature supporting advised lupus, and CITES advised lupus is a very useful tool for both clinicians and patients, so now we have that external validation. We're not affiliated with the Lupus Encyclopedia by any means, and so that's a huge positive. The other thing is, or secondarily, Dr. Don Thomas sits on the guidelines, sits on a panel of 15 clinicians who form the guidelines for diagnostic use, diagnostics within lupus, and so to have him put that in the public domain and to reference our company, our test, the algorithm, multiple aspects about the organization and the test that we provide is huge for us. So we are still not in the guidelines, but I think we're having meaningful progress, especially in one year's time, to have that reflected in a publication I think is huge from our standpoint. And so we're seeing some progress just as we're seeing with ASP, just as we're seeing with cost control. You see it really across the board, results being reflected in many of the things we're doing given our strategy.

Okay, excellent. And then the last one for me, I believe you signed a high mark Blue Cross Blue Shield earlier this year. We'd just be curious how conversations might be going with health plans. Do you expect 2024 to be a year where you can make some headway on that initiative? And then is it fair to say that we're, you know, is there any update on the LCD for revised lupus to neridian IP? We'd assume we're just in a waiting pattern, but any commentary you have there would be helpful.

Great. I'll start with Neridian first and then work back into the commercial payer landscape. From Neridian, we continue to be in a holding pattern. And what that means is last year, September-ish of last year, Exogen submitted a request for coverage through Neridian, our local MAC. And we got acknowledgement that we have a completed request. but we wait in limbo for either a draft LCD to come out or a CAC meeting, at which point we'd be on the agenda, ideally, and then progress there to a draft LCD. So until that happens, we remain in a holding pattern and no further update there. We continue to have coverage and reimbursement consistent with the clinical lab fee schedule, our expected reimbursement for our Medicare claims. No change on either of those fronts to report. As it pertains to commercial insurers, I've taken the position that or the approach that kind of referencing activity is not reflective typically of the progress, the underlying progress that's made. And what I mean by that is you can have very productive discussions, but unless cash comes in the door, it's... I don't know that speaking about it is that productive. And so the approach we've taken is to reference folks to our trailing 12-month ASP, which at the beginning of the year was $279, and then Q3 is $320. So we've seen a $40 increase in our trailing 12-month ASP, and that's reflective of multiple efforts that we've put in place, some of them on the managed care front and having discussions with individual plans, Highmark's certainly part of that portfolio of efforts but then we also have our appeals efforts our prior collections we've got changes to our patient responsibility and really the confluence of of activities is resulting in improved ASP I've got no major contracts to report on we have talked to many medical directors over the past quarter and gotten some positive feedback but also some areas for improving And so kind of getting on both sides, but ultimately trying to turn those conversations into cash in the door. And we've been effective at doing that over the first nine months of this year. We expect the bulk of those efforts to be reflected in our ASP in Q4, Q1 into 2024.

Excellent. Sorry, one last quick one for Kamal. It's great to see the cash balance go up in the month of October instead of down. I guess as we think about, this AR dynamic that you laid out, is there a chance that we can continue to see this type of trend advance into early next year? Or do you think we'll see this benefit sort of be realized by the end of 2023?

Thanks, Mark, for that question. In regards to AR, we ended 2022 with an AR balance of $6.1 million. That's kind of how I've been viewing the baseline. Now keep in mind our volume did increase year to date through Q3 versus through Q3 22 by 6.2%. So when I'm thinking about AR internally for managing the business, I'm viewing it as baseline 6.1 million because that's how we started the year. Volume's up 6.2% and ASP's up a bit. So that puts me around 7 million of where I feel comfortable with the AR getting back to. if we make it through all the claims by end of year, which, as we just indicated, we brought AR down by $5.5 million in October. So we're making great progress, collecting more than we anticipated, and should see that AR number get back down to those normal levels by the end of the year. Awesome. That's it for me. Thank you.

And the next question comes from the line of Dan Brennan with TD Cowan. Please proceed with your question.

Great, thanks. Congrats on the quarter. So this question may be on the fourth quarter math. So we calculate what an ASP in the quarter around 400, right, roughly, you know, to get your numbers X to 600,000 prior periods. That would imply at the minimum guide for the, you know, for the full year, you said 50 million, that would imply, roughly around 28,000 tests in 4Q. Is that reasonable? Pricing at least stable with 28,000 would get you to the bottom end of that range?

I think that's a little aggressive on the ASP side and underperforming on the volume side. We didn't break out our guidance specifically by volume or ASP, but to give you some qualitative feedback there, we believe we'll have higher volume than that, likely. And ASP at 400 would be a bit of a jump from where we're at at the 320. Oh, sorry.

I was talking about the in-quarter ASP, not trailing 12-month ASP. Sorry about that.

Gotcha. So in-quarter ASP still jumping up to 400. In Q4, it may happen. I don't know yet, but I still think that's aggressive.

Got it. So, yes, we can do the math, I guess, offline just on the ASP math. I was just wondering, wherever we exit the year on like an in-quarter ASP, how do we think about like the fourth quarter in-quarter ASP as a jump-off point for 2024 ASP? Should we increase from there? It sounds like from, you know, the answer to Mark's question, John, it seems like, or Kamal, it seems like there's some clearly price is the focus, but it sounds like there's even some more near-term tailwinds for price. So depending upon where we land on 4Q price, should we expect that number to improve as we go through 24?

So one way to think about it, if you look at the seasonality of the business going from Q4 to Q1, calculating just the quarter ASP, Q421 to Q122 went from 304 to 281. And then you saw a similar decline from 22Q4 to Q123, 327 to 262. Now, the decline from 22 to 23 was a little bit more because the PLA code went to the CFLS schedule, and that also impacted what that rate was going into the year. But what's in common in all the other years, as you can see when you calculate the Q1 versus Q4 ASP, is the deductible reset. That's something that I do factor in for modeling purposes. What's that going to do to revenue for next year? So in regards to seasonality between the quarters, I should say. So, yes, the deductible does cause it to come down slightly in Q1, but similar to what you've seen in every year, it builds up from that point.

Got it. Okay. That's fair. Yeah, we can work on thinking about the full year. From a patient pay basis, like how did that go in the quarter? I know that was a new initiative you guys put in place. Just wondering what kind of benefit or kind of impact you saw from that.

In the quarter, virtually no impact from patient pay, and I'll explain why so far. So we do everything we can to work with the patient's insurance before going back to them. So what that means is we file a claim after we perform the test, and then we'll work to appeal that patient's claim if it was denied. And so that may take, on the shorter end, around 90 days, and on the more traditional end, up to nine months, if you will. And in that process, we're going back and forth, getting medical records. It may be different reasons for denial, so having a discussion around that and potentially getting on the phone with a medical liaison or a director there and having a discussion clinician to clinician. Once that process has been exhausted, then we actually go to the patient. And so that's when that would start to reflect in our ASP. But yet the policy, and you have to set the expectation with the patient up front, so the policy has been put in place as of early July because we want people to be transparent. We want people to know that if we have changed our prices, what they are. And so you see the impact to volume, if you will, from that change once you telegraph that to the public. and then actually get it reflected in ASP once you start billing patients, which doesn't come for some time, as I just explained. So it's a, does that help?

Yeah, no, no, it definitely helps. No, definitely, I understand it then. Okay.

So that'll be some detail when it's coming up. Sorry.

Nope, I got it. And then maybe just final one. I know you talked about being profitable. I think it's $75 million in revenue, 160% gross margin. Presumably, the success you're having here with the program, if anything, would ideally hopefully get you to that point earlier, or does anything really change in kind of how you think about the road to kind of cash flow break even, given some of the success you've had so far?

So nothing changes in the fact that if we keep our operating expense roughly where it is, At $75 million in revenue and that 60% gross margin rate, we obtain a cash flow positive state. And so that's the picture that we believe we need to hit from a goal standpoint. You're right that we've been working kind of ahead of schedule, if you will, to get there. And we have some great momentum with more things on the come, as we just discussed, specifically citing some of those patient rates and what have you. So our cash burn rate has come down. Year over year, we're taking a look at from an adjusted EBITDA standpoint, year to date, first nine months of 2022, $26.4 million in adjusted EBITDA, a net loss there. And then from 2023, we've cut that in half. As we sit here today, our cash balance is around $30 million, a little bit above, and we expect to be there at the end of the year as well. That gives us quite a bit of time. We currently believe we're well positioned into late 2025, early 2026 to continue operating with our strategy, our plan, and see what type of impact that has. And we'll see how close we get to our goal. And we believe we're well on track in delivering ahead of schedule here. So nothing changes in the overall picture. The pace is, you know, I I'm happy with the pace that we're making. I wish we were going faster, a little bit faster, a little bit better always, but I am happy with the pace that we're taking now.

Great. Perfect. Thank you.

And the next question comes from the line of Andrew Brackman with William Blair. Please proceed with your question.

Hi, guys. Good afternoon, and thanks for taking the questions. Maybe to start on the Johns Hopkins Agreement and just sort of recognizing there's probably a little bit of work that still needs to be done there before launching a commercial product. But John, can you just talk to us about how investors should be thinking about evaluating the success of that agreement and not trying to pin you down on any sort of timeframes or timelines, but anything to keep out in terms of key milestones here? Thanks.

Yeah. Hey, Andrew, good afternoon. Thanks for joining the call. So we are very excited about this opportunity. Really, you know, We're working to develop clinically meaningful technology that meets a high customer need. We've laid some of these criteria out in the past, but it has clear clinical utility, proprietary nature to the technology, a path to value-based reimbursement, and really this agreement satisfies all of those requirements, and that's why we're so excited to partner with the team there. It's a very renowned group of folks which discovered and created this invention. I'm very excited from that standpoint. To give you a little bit of background, lupus nephritis affects roughly 50% of the lupus patients, so we're broadening our coverage of the lupus patient journey. This technology really has gained a lot of attention, certainly at ACR. That's, again, the annual meeting, American College of Rheumatology. Last year, the first abstract came out there and was presented. So over the last year, we were able to secure an exclusive worldwide license to develop these markers into clinical tests. And we've already initiated a prospective trial. That was actually part of our R&D spend this year to recruit patients for development, and that started. So we anticipate being able to move fairly quickly. Now, I still don't expect a significant revenue contribution within a 24-month period, which has been the timeline I've kind of set as a threshold for laying a lot of this stuff out, but that may change. But at least as it stands now, I think that's a conservative approach to this. There's two drugs on the market in this area to help treat this condition. One is from GSK, the other from Arinia. And we're working to see how this tool can start to improve trials and research in this space as a first step. As I'm sure you know, being able to profile these patients, identify these patients is very important and useful in in the development process for many of these pharma companies. So that's a logical first step for us to de-risk and accelerate the path here. It's a protein-based technology, which aligns very much with our existing competency, also helps from a value-based pricing standpoint, gives us a potential opportunity to crosswalk on a code when we get to that point. But, again, kind of lends to some of the excitement we have. And then maybe kind of to wrap it up, we have to follow the science. So that's the number one thing here. As you said, there's still some work to be done. But ultimately, we envision this test as a measure of disease activity. So that'd be used to track patient response to therapy over time and would inform on an individual patient's treatment response. So likely a tool that's used to manage this patient throughout their journey. And we can go from there. We'll be able to flesh this out again as the science kind of dictates and share some of those meaningful milestones, especially if they hit print or publication, but it's an area that we believe aligns very closely with what we're doing and should be a very nice bolt-on for us from a development standpoint.

Okay, that's terrific. And then, you know, you've done a lot to revamp sort of the appeals process here over the last year. Can you just level set us on where you think we are in recognizing the benefits from those changes and sort of what gives you the confidence that those are going to continue to sort of bear fruit as we look to 2024? Thanks.

Yeah, we're really in the pregame warm-up, Andrew, is the way we view it. And the reason I state that is the revamp of an appeals process takes time. We held claims for the first six months of the year. And In doing so, it let us put many of these changes in place. We implemented the customer-facing policy changes here in July. But to actually see results in an ASP standpoint, it takes that nine to 12-month period. And that's why we've worked hard to communicate around Q4 into 2024 being the timeline that we expect to see consistent improvement in ASP. Now, it just so happens that Some of these changes have been reflected earlier, and if we're looking at claims where historically we had more of a challenge getting reimbursed and we've been able to turn that tide, that's great. Our primary focus has been current claims where we haven't passed some of the timely filing restrictions and where we're able to make some meaningful progress on a per-payer medical policy standpoint. So those haven't come yet. We're well in process. We've implemented the changes to kind of attack that area, if you will, But we still have a lot more to see and to do, because some of this is also a significant learning process. As we get feedback from individual payers, we'll adjust our game plan. There's certain letters that are going to be more effective on an appeal basis, and we'll find out how to make our less effective ones more effective over time. So I think we're in early stages here. And again, we conveyed that Q4 into 2024 would be where we start to see progress Great to see it earlier ahead of schedule. Doesn't mean that there's not more coming. And so I would expect our original communication to ring true here.

Okay. Super helpful. Thanks, guys. Great.

There are no further questions at this time. And I would like to turn the floor back over to John Abali for any closing comments.

Thanks again for joining the call. I'm extremely proud of the team and their efforts this past quarter. We're now very consistently demonstrating performance in key areas, and we've transformed the organization into a more profitable entity. We've successfully implemented many changes to improve ASP and are seeing momentum there. We've reduced our cash burn and thereby significantly extended our runway well into 2025 or early 26. Plus, we're evolving our R&D pipeline, which we expected to lead to growth in future years. So our strategy is clear. We're executing well. We have the rheumatology community in town right now for their annual meeting, and it's just an energizing time for us with everything going on. And I'm excited to continue building a stronger Exogen going forward. So thanks again. We very much appreciate you joining the call.