Exagen Inc.

Good day, ladies and gentlemen, and welcome to the Exogen Q1 2023 Unix Core. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Ryan Douglas, of Investor Relations. Please go ahead.

Good afternoon, and thank you for joining us. Earlier today, Exogen Inc. released financial results for the quarter ended March 31st, 2023. The release is currently available on the company's website at www.exogen.com. Chana Bali, President and Chief Executive Officer, and Kamala Dowie, Chief Financial Officer, will host this afternoon's call. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal securities laws which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements. All forward-looking statements, including without limitation, statements regarding our business strategy and future financial and operating performance, including guidance for the quarter ended June 30th, 2023, 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 description of the risk and uncertainty 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 subsequent filings. The information provided in this conference call speaks only to the live broadcast today, May 15, 2023. Exogen disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise. I'll now turn the call over to John Abali, President and CEO of Exogen.

Thanks, Ryan, and thank you to everyone joining the call. Today I will discuss our first quarter results and give updates on our strategic initiatives, path to profitability, and research pipeline. I'll then hand it over to Kamal, our CFO, for details on our financial results. As always, we appreciate your continued support of Exogen. When I arrived at Exogen, we put together a plan to reduce expenses across the organization and grow the business to profitability. Now that I've been leading Exogen for seven months, it's great to see that the changes we've implemented are starting to have a meaningful impact on the business. and are reflected in our commercial results and reduced operating expenses. For the first quarter, I'm happy to report that total revenue was $11.2 million, driven by a record volume of 37,300 advised CTD tests. Volume increased 10% over the last quarter and 21% year-over-year. I'm excited about the momentum our commercial team has created as they have remained focused and highly motivated throughout the implementation of these changes. My strategy has been to orientate the company on a path to profitability, and the results in this quarter give us our first opportunity to convey the impact of our initiatives. For the first quarter, SG&A and R&D expenses decreased to $13 million, which is an improvement from an average of $15.5 million per quarter throughout 2022. The decrease was primarily due to the reduction in force that took place in December. The assumptions we made in planning the reduction have proven to be on target, and we now believe that we have the right people in place and are operating at the optimal size. Kamal will elaborate on the financial performance, but in short, I'm very pleased with how we've started the year. Increasing ASP through changes to our operations and revenue cycle management is a key component of our strategy. Trailing 12-month ASP through Q1 was $279, which we anticipate improving in 9 to 12 months as our efforts begin to materialize. Keeping in mind that first quarter ASP numbers include the effects from deductible resets and final Medicare pricing on the clinical laboratory fee schedule, we feel ASP trended in line with expectations for the first quarter. As we've consistently detailed, We aim to improve ASP through multiple initiatives, both in the short and long term. These initiatives include steps taken recently to improve our revenue cycle operations by increasing our required documentation at time of test order and revamping our appeals process. Additionally, we've been aggressive with appeals, filing more than we did for the entirety of 2022. As a reminder, the appeals process can take upwards of a year, depending on what level of appeal is reached, and we should see the results reflected in higher ASPs. Over the long term, we believe this approach will be an effective way to educate insurance companies regarding the value of advised CTD and expect these efforts to improve coverage with plans. As part of our initiative to improve revenue cycle management, we made a strategic decision to hold first quarter claims until the second quarter while we optimized our appeals process. This additional time enabled us to focus on process improvement without the pressure of triggering timely filing deadlines. As anticipated, this resulted in a temporary increase in our accounts receivable balance by $3.2 million and subsequently impacts the cash balance, the effects of which will diminish as the year progresses. We recently refinanced our term loan to better align with our strategic focus and to alleviate performance covenants that restricted our pursuit of profitability. In a tightening debt market, we had the opportunity to refinance from a position of strength to obtain terms we found advantageous. This benefits the company in multiple ways. The new loan provides flexibility in the performance covenants. It deleverages the organization and resets the interest-only period to three years, all of which allow us to focus on achieving profitability in the medium term. Additionally, our monthly payment is lower, and we were able to make a $10 million principal payment without penalty. There are a few other details Kamal will cover, but in general, we found this to be a very positive development which better aligns with our strategy. Moving to R&D, after a thorough review, I've decided to end our RADAR program, including associated clinical trials. While there remains a strong clinical need for a predictor of drug response in rheumatoid arthritis, and RADAR has many promising aspects to meet this clinical need, We believe the commercialization hurdles are significant and therefore prohibitory, given the current strategy of the organization. We continue to develop products for monitoring of disease activity in lupus, along with a predictor of drug response for lupus nephritis. Both efforts remain active, and we plan to give updates when we have meaningful outcomes for market development. We ended the first quarter with $1.1 million in R&D spent, which was light due to the timing of pipeline projects and trials, And for the full year, we anticipate our R&D spend to be around $6 million. Lastly, I really value in-person connections with our customers, and I'd like to share an opportunity I had to spend a day in the field with a top rheumatologist in Los Angeles who sees in excess of 20 patients per day. These types of opportunities are incredibly rewarding, as I was able to experience firsthand how our test is used in clinical practice and the positive impact it has on patient care. First and foremost, What was really insightful and motivating was seeing the clinicians serving patients. And it's very clear that clinicians in this subspecialty have a unique bond with the patients in their practice, given the types of challenges they face in their journey to achieve a correct diagnosis. The physician I shadowed really connected with her patients on a personal level, and this was the motivating part, to be welcomed into the clinician-patient interaction and observe firsthand how our test was being positioned and utilized as the definitive solution to answering a patient's prior ANA-positive finding. The office environment is fast-paced, and clinicians trust Exogen and the Advise brand to deliver superior quality and service in helping them solve the differential diagnosis of their referred patients. This was the first of several visits I hope to have in the coming year, and as I saw firsthand, in combination with the record Advise CTD volume we demonstrated this quarter, clinicians find the Advise platform extremely helpful in their everyday clinical practice as the brand they can trust. I'm extremely proud of the progress made by the Exogen team this past quarter. Our strategy has been highly targeted as we've gone through every aspect of the organization. And it's exciting to see the progress reflected in the quarterly results. We still have a significant amount of work ahead of us regarding the reimbursement of advice, which we're working on, and we'll continue to provide regular updates. But so far, what we have set out to accomplish is starting to take shape. I'll now turn the call over to Kamal.

Thank you, John, and good afternoon, everyone. Total revenues in the first quarter of 2023 were $11.2 million, compared with $10.4 million in the first quarter of 2022. Total revenues were driven primarily by testing volumes for a buying CTD, which as John mentioned, was a record 37,300 tests delivered. Other testing revenue was $1.4 million in the first quarter of 2023, compared with $1.7 million in the first quarter of 2022. The trailing 12-month ASP was $279 per test compared to $285 per test in Q4 of 2022. Cost of revenue were $5.9 million in Q1, resulting in a total gross margin of 47% compared to 44% in the first quarter of 2022. The increase in gross margin percentage was primarily due to an increase in combined CTD volume, which resulted in favorable impact of absorption of cause and lower royalty expense due to holding claims. Operating expenses were $18.9 million in the first quarter of 2023, compared with $20.1 million in the first quarter of 2022, primarily driven by decrease in employee-related expenses due to a reduction in force in early December 2022. For the first quarter of 2023, our net loss was $7.7 million compared to a net loss of $10.3 million for the first quarter of 2022. Looking at our balance sheet, as John mentioned, we refinanced our debt on April 28th. The refinance was through our existing lender, who we have a great relationship with and have been working with for six years. After the prepayment, the balance of the loan is $18 million. As disclosed in the 8K, the terms of the agreement include a floating interest rate, which is the greater of 10% or prime plus 2%, resetting the interest-only period to three years, the implementation of a new management plan, and improved covenants. Cash and cash equivalents as of March 31, 2023, were approximately $52.2 million. As John mentioned, with our revenue cycle management strategy, the claims held from Q1 until Q2 contributed to the AR balance increasing by $3.2 million, which is offset by a lower cash balance. Our cash burn of $10 million includes the $3.2 million of AR that was a result of holding claims. If the AR increase was excluded, the cash burn would have been around $7 million. While there is always risks to the execution of our strategy, we expect cash burn to improve throughout this year. Post refinancing our debt and cost cutting measures, we believe we're well capitalized to continue executing our strategy. Given the breadth of the changes that are in progress, we remain prudent in our approach to guidance. And for Q2, we're projecting revenue in the range of 10.7 to 11.2 million. For year over year comparisons, Please remember that in 2022, payments for Medicare were delayed from Q2 to Q3. Finally, as these strategies materialize, our revenue growth will be a composite of both volume and ASP improvements. We will now open the call for questions.

Thank you very much, sir. Ladies and gentlemen, we will now be conducting the question and answer session. If you'd like to ask a question, please press star and then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then 2 if you would like to remove a question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Mark Massara of NTIG. Please go ahead.

Hey, guys. This is Vivian . Thanks for taking the questions, and congrats on the strong print. On the guide, it looks like the midpoint of the Q2 guide is below Q1 levels. So, I guess, Kamal, you mentioned towards the end of your remarks, but what are the assumptions on the balance between ASP and volumes and, I guess, just any conservatism factored in there? Thanks.

Hi, Vivian. Thanks for the question. So, in terms of the assumptions being made, obviously it's a composite of ASP and volume. Now, volume exceeded expectations in Q1. We came off a reduction in force on December 5th where we reduced the territory from 63 to 40. So, I was very pleased to see the volume come in where it did for Q1. As we stated in the prepared remarks, the ASP could take time for it to grow to the levels that we want to see it grow to. We signal 9 to 12 months before we see ASP at the levels that we want it to contribute to the growth.

Okay, perfect. And then maybe another one to you, Kamal. In terms of OPEX, which came in, I guess, a little above our thinking, can you help us think about any one-timers that may have been in there from a workforce reduction And maybe you could also help us think about how to quantify the savings that you might expect to see with the discontinuation of radar. Thanks.

Sure. So the one-time expenses were captured in Q4 of 2022. That was the severance payments and the goodwill impairment of $5.5 million. So Q1 was a very clean quarter. That's why we felt comfortable in saying that if you look at the average outbacks, for 2022 by quarter, it comes in at around $15.5 million. And then Q1 of 2023 came in at $13 million. So, look at that as about a $2.5 million savings annualized, $10 million savings on the year. So, that's how I'm thinking about the reoccurring expenses. Now, to the second part of your question with radar, We didn't have a lot of radar expenses in 2022. That's why you can't look at the year-over-year savings and assume radar is in there. But John did guide to R&D expenses full year 2023 will be around 6 million.

Okay, perfect. Maybe if we can just squeeze in one more. So you spoke about holding some Q1 claims until Q2. So I guess on that front, I was wondering if there were any material revenue collections from prior periods in Q1. And that's it for me. Thanks.

Sure. So, in terms of impact on revenue, there is no impact from holding claims. But where you do see an impact is an increase in our AR, which ultimately is offset with lower cash. So, the way I'm looking at this, as AR is about 3.2 million higher quarter over quarter from Q4 to Q1, and that negatively impacted cash, which will be offset as we start to fill and collect on that. So it's just a temporary lower cash that will be offset during the year.

Okay, awesome. Thanks for taking the question.

Thank you. The next question is from Kyle Mixon of China Accord. He's going to have

Hey, guys. Thanks for taking the questions. Congrats on the quarter. Just starting with the second quarter, it is like a little bit of a step down. And it wasn't quite clear what you just said, Kamal, about the kind of volume and ASP dynamics. I feel like ASP, you know, we shouldn't really expect that to really bump up too much quarter to quarter. But on the volume front, I mean, you just put up the most volume in, like, two years or so. Like, it's just great, great numbers. Would you mind just talking about that a little bit? Because if you kind of back out the payment that was shifted from 2Q to 3Q last year, you get like minus 4% decline year over year in the second quarter of 23. So maybe let's just walk through some of these factors and how you're thinking about it. Come on. Thanks.

Sure. So obviously the driver there is going to be ASP. And let me walk you through, you know, the quarter over quarter ASP because it came in in Q1 exactly where our internal models had it. There is no surprise internally for Q1 ASP. The drivers there are going to be Medicare moving to the CLFS schedule or pricing. The PLA code starting in April 1 of 2022 was around 200 higher than the CLFS pricing, which is still significantly higher than what it was prior to having the PLA code in place. And then the second aspect of the ASP from Q4 to Q1 is deductibles resetting. And then keep in mind in Q4 2022, if you're looking at a quarter per quarter, there were some year-end adjustments that were very favorable to the Q4 2022 ASP.

Great. Thanks, Kamal. And the volume, I mean, it looks like a record just by the way. I think I mentioned a few years. So that's all good. And I guess that makes sense. Maybe, John, on the ASB, I mean, I'm coming up with like 263 for the quarter. I could advise maybe just walk through why that would have declined quarter to quarter. Like you kind of mentioned some factors, but I think it would be helpful to describe, you know, why there's these moving pieces and what kind of contributes to like the biggest kind of headwind or bottleneck for average revenue per test.

Certainly. And thanks for joining, Kyle. Good afternoon. From an ASP perspective, some of the headwinds, as Kumail mentioned, is, you know, in Q1 we have the deductible reset, which is consistent with most of the industry. It occurs annually and then kind of smooths out throughout the rest of the year. We also had our Medicare pricing on the clinical laboratory fee schedule, as we mentioned. Headwinds or tailwinds throughout the year will be gains in medical policy. from the different insurance plans, and that's something we're actively focused on. We've set that as a top priority with our market access team. We've adjusted the compensation structure for all of them to focus on that. And we do think that our appeals efforts will really help in that respect. I think that will be a main driver for us in terms of progress for ASP over the course of the next, call it nine to 12 months, is really what our revenue cycle optimization yields. I think that From our perspective, we're trying to increase the quantity of appeals and then also the quality. We've hired technical writers who I've worked with in the past that digest all of our clinical information, all of our dossiers, along with the studies which we've published on, and really help us draft a concise message which articulates to the payers the value of the test. That, coupled with high frequency of appeals and taking those to higher level of adjudication, external type appeal, for example, I think will be primary drivers for the ASP over time. And again, we think maybe the back half of this year into 2024 will be the appropriate timing for starting to see some of those impacts. We do agree with you on the volume side. It was a fantastic quarter, really moved past any of our internal models. And that's To be honest with you, we're still identifying some of the business patterns that are developing with some of the changes that we've implemented, and that is the primary driver behind our guidance for Q2. We're just trying to be prudent in maintaining a conservative approach there and seeing when exactly some of these effects, which we anticipate, are likely to come into play.

All right. That was great, John. Thanks for that. And just moving to some of the things that the company can actually kind of control itself, and that's the termination of the radar program that was kind of an attractive I asked that at one point, but I felt like on that last, you know, earnings call that it was sort of almost emphasized a bit. So this makes sense, I guess. I'm just curious, though, if that was about the ROI of that program or did that – was that one of these tests that had, like, a lower gross margin? And that's kind of consistent with, like, your strategy going forward. And, yeah, I mean, just on the gross margin note, I just – I know, like, the instrumentation for that was kind of sophisticated relative to, like, maybe some of the advised tests. So just curious about that. And just overall, I mean, how is this, you know, discontinuing lower margin test – you know, strategy kind of affecting margins thus far, if at all?

Certainly. So I'll try to unpack your first question, and then you just guide me in terms of if I'm hitting also on the second portion. As it relates to radar, you know, if you evaluate this against This product, this development product against the development criteria we put in place, it checks a lot of boxes. We've been trying to be as clear as we can as to what criteria we're evaluating against internally. And just a couple notes, it certainly hits a top need within the space. It's proprietary technology that we had licensed out of Queen Mary. And the utility was very likely to be proven out. So I think that it had some very attractive qualities, and that's really, to be honest with you, why it took some time on my side to evaluate it to its full potential. I did end up hiring actually some external consultants that I've worked with in the past to come in, and I just – there was a lot of internal emotion tied up in this project, and I wanted to evaluate it more objectively. So from my perspective, there were some uncertainties there, certainly around Medicare and ultimately the path to obtaining coverage. and I can go into that in more detail if needed, but I think on the surface, there's a long line, significant timelines associated with getting through the Moldex program and this product, and there remain some uncertainties with the ability to do that. It was also highly dependent on a procedure which is not in widespread use across the industry, and I thought that that hurdle was substantial. Nevertheless, when I take a look at everything that was... on the table for development of this opportunity, I just came to a different conclusion as to how realistic it is to bring this to market and the capital requirements needed to do so. So I felt like the timelines were likely much more significant than we had originally planned for. And as you mentioned, that certainly impacts the ROI. The second part around gross margin and directly how some of the other testing is impacting that and discontinuation of some of that other testing, We've really tried to focus on advised CTD. I think you see that reflected in the performance this past quarter with volume, and we really are excited about the results that that's generated. Our other testing revenue has come down a little bit in Q1, and I think that that's just a factor of our focus on advised CTD. And so some of the discontinuation, as we said, would turn out to be relatively immaterial to the entire story. I think you're seeing that in general. But again, very excited about how the Advise CTD product has performed here over the last quarter. And if we can continue to execute on our ASP efforts, I think hopefully we'll start to see some of those effects as well.

Okay. That makes sense. Thanks, Sean, for the detail and thanks, Co-op, too. Thanks, guys.

Thank you. The next question is from Andrew Brackman, Austin, England.

Hey, guys. This is Dustin for Andrew. Thanks for taking our questions. First, I just want to get an update on the Medicare LCD you guys submitted last year, confirming you guys are still getting paid at that crosswalk rate. And then secondarily, just a general update on the PLA code-related disruptions you're seeing with private payers and those new contracts that you might be getting. Is the pricing coming in at where you guys would want that to be medium to longer term.

Certainly. Thanks for joining the call, Dustin. So briefly, an update on the LCD. No material changes to report at this point in time. And just to recap, we have submitted a request for an LCD for advised lupus. That submission has been acknowledged by Neridian, who's our local MAC. that it's complete and pending. And so until we end up on a meeting agenda, there won't be much to report, and the timelines there are fuzzy at best. So we remain in the queue, and until there's something material that Naridian does, we'll continue to remain pending in that queue. But everything that is in our control has been completed relating to the LCD request. Your second part of your question was, relating to payments for Medicare. So we have claims with 2023 data service under the new pricing, $840 for our current PLA code, which have been paid by Medicare and no changes to report there relative to Q4. As we mentioned in the prepared remarks, we have held claims here for Q1 as we've revised our appeals process. And so that's part of that as well. We just want to make sure that we have everything buttoned up before potentially triggering any sort of timelines that are dictated by the payers. But we treated all claims similarly there. But as it relates to 2023 data service, nothing new to report and still getting covered and paid by Medicare at the appropriate rate. The next part of your question dealt with PLA code disruptions with commercial payers. We continue to see those. We haven't carved those out individually. There's no material write-downs, as you see here in the quarter. So not a whole lot new to report in that context. But if you do take a look at the trailing 12-month ASP, we're down about $6 here in Q1. We think that's mostly a factor of deductibles along with the revised Medicare pricing. But nothing new to report there. We've tried to drive attention towards trends in ASP over time. I think we can report on any sort of coverage changes or wins in a given quarter along with any contracting wins. I think the real thing that matters is Do those contracts perform over time, and are they reflected in your ASP? And so I think, you know, if I'm evaluating an organization or a business in this area, I think you would want to see material changes in the ASP, and that's where we've tried to direct folks as well. So I think continuing to monitor that, which we've articulated, we expect to see changes here somewhere in nine to 12 months. It gives us a full cycle of appealing. with the claim date of service of Q1, so sometimes towards the end of the year. I think you'll end up seeing some of those changes, but nothing significant to report on either front to directly answer your question.

Yeah, that was great. Thank you, John. Kind of a related question. In those Medicare, medical policy decisions that are being made are a lot expected to happen in the second half of this year. or should that be more spread out over a 12-month basis?

Certainly. We expect to get quite a bit of feedback in the second half of the year. So the first half of the year, I think, is littered with quite a few submission dates, although there are policy determinations occurring in the first half of the year. But I would say the majority are centered in the second half of the year, Q3, Q4, where we expect to get feedback on our existing body of data, including our capstone study. And we believe we have a strong data package, but as I've tried to communicate to investors and whatnot, we'll know for sure after we get formal feedback from many of these policies. So second half of the year, you're correct.

Okay, great. And then just one more on the pipeline. You briefly mentioned the two other projects you're working on. If you could go into more detail on those two, that would be great. Thank you. Certainly.

In terms of our pipeline right now, we are actively engaged in two programs, one focused in lupus nephritis, the other focused in a disease activity score for monitoring of lupus patients. We believe both are high clinical needs within the space. And if you were to talk to rheumatologists who are treating lupus patients, I think it would be easily validated that either product fits a strong clinical need. We believe we have a pathway to proprietary technology in both cases. And we believe there's clear clinical utility along with a proven approach or pathway for us for Medicare and subsequent commercial reimbursement. So in terms of checking the boxes for what we're looking for, both of those products exist. We'd sell them through our existing channel. So again, another positive there. I hesitate to go into significant detail on our pipeline products when I don't foresee revenue in the next 12 to 24 months. I know that that's a change from how the companies handled this previously, but I don't want to commit to something and then have to back off it, if you will, at some point in time. So for the near, call it near to medium future, we'll continue to develop our report if we file IP or we have some major determination. to update on, but from this perspective, until we have line of sight to actual revenue within the organization, I'll keep you posted on what programs are ongoing, and then we'll update from there.

Great. Thanks for taking our questions. Certainly.

Thank you. The next question is from Dan Brennan of TD County. Please go ahead.

Great. Thank you. Thanks for taking the questions. Maybe a couple, just starting off on withholding claims in one queue, just what kind of impact did that have and what, how will that flow through into Q2 and the rest of 23?

Certainly. Thanks for joining the call, Dan. So. For sure. In terms of impact as we see it, so as we mentioned, we saw accounts receivable increase by 3.2 million and we had a subsequent impact to cash as a consequence of that. This was all planned, and just to reiterate at a high level, the reason why we are doing this is so that it gave us the freedom to adjust our billing and revenue cycle processes, ensure that we have basically all of our ducks in a row for our appeals process before filing claims so that in the event we do get denials, we don't start the timely filing clock for those denials, the response to those denials, ahead of where we... where we really want to be. So it's really from a strategic aspect. We have the cash that allows us this type of flexibility. We feel it's in the best interest of the organization. So we expect the increased AR to reduce out and then subsequently show up in terms of an increased cash balance or a slower burn over the course of the year. But that's how this would rectify over the next nine months.

Great. Thanks for that. And just for the to remind us how we think about the burn for this year and in terms of ultimately tapping the capital markets, like when would you anticipate doing that or the need to do that?

Thanks, Dan. In regards to the burn, you know, we gave that number of around 7 million because of the what we just talked about withholding claims that if you back that out, then the burn in Q1 would have been close to 7 million. And the way we're looking at this is in each quarter we should be seeing, you know, relatively small improvements to the cash burn quarter after quarter as we continue to see our ASP increase over time and control expenses. So I think that $7 million number for a burn in this quarter is your high point for the year.

And then in terms of impact relative to capital markets, the way we're thinking about it internally is, you know, we just came off a quarter where, as mentioned, volume is the highest volume we've ever had from a quarterly perspective relative to advised CTD. And from that, you know, it beat our internal models. And so from that perspective, really the timing and magnitude of the ASP impact here over the next 12 months is going to be highly material to when any sort of cash needs fall into place. We continue to look at market conditions and stay abreast of that. That's why we moved with some of the debt decisions we did more recently. But at this current time, we believe we have the focus, the flexibility to focus on advised CTD. That's what we're doing. And then depending on how some of these things fall into play, whether they're you know, ahead of schedule or maybe a little bit behind, we'll have to see, but that will dictate timing.

Great. Now, thanks for that. And then you've talked about a couple of times how strong the volumes were and some of the initiatives you've already put in place have kicked in faster than expected. Is there any reason why the kind of year-over-year volume growth you achieved in 1Q shouldn't continue in 2Q? To help us think through, I think you had talked about it earlier in the call, you would have expected some of this benefit to be seen maybe in a few quarters, two, three, four quarters from now, but you're seeing some of it now. So is there any reason why it was a one-time pop and then it's going to revert back, or just kind of help us think through Q2 and the volume progression as we look at it sequentially?

Certainly. I think that's a great question. So from our perspective, you know, we reduced about a third, a little bit more than a third of our sales footprint in the U.S., and we expected that impact to hit more in Q1. Now, it didn't. In fact, we actually had very substantial growth in Q1. I think the way we're thinking about it internally is we still anticipate some impact from reducing a third of our sales force. We think the revised focus on by CTD is the right strategy, and it's showing up in the numbers. But until we see a couple quarters of consistent growth in that respect, I think the hypothesis is still valid. Historically, the company has conveyed that it takes roughly two quarters before you see some trail off when territory gets – is vacant. I'm new to the story in that sense and still analyzing this from my perspective, seeing how we can minimize that. And like I said, when you make such a dramatic cut here at the end of Q4, I anticipated some impact in Q1. So that's why we're thinking kind of Q2. That's anticipated in the guide. Again, just trying to be conservative. Given the significant size of the changes that we've made, there should be some impact here in Q2. But again, we were proven wrong in Q1.

No, that's great. And then maybe just last one is on pricing. Obviously, this is critical focus and there's a lot of moving pieces. I'm still getting my head around it. But just as we think about for the year then, you talked about it seems like sequentially pricing is expected to go up. I know there's a lot of levers here and there's a range of outcomes that'll persist as you get through the year with some of the initiatives, but just any color how to think of the sequential pacing when you might see maybe some of the bigger step ups or just kind of any help how that progression occurs. Thank you.

Yeah. Yeah. Again, a great follow on and the way we're thinking about it internally is the changes that we're making now, call it Q1, we anticipate seeing the effects of those changes in approximately nine to 12 months. And the rationale behind that being, you initially perform a test, you file a claim, we're conveying that we think the opportunity exists in our appeals process. That appeals process is several cycles, call it two to three cycles per claim. And so for that entire process to play out, take somewhere in the nine to 12 month range, and that's just based on my experience. So we would expect to see the effects of the changes we're implementing now reflected in ASP sometime in the fourth quarter, potentially Q1 of 2024. And that's as simple as that, really. So the way we're thinking about it is we're likely at a stable ASP with maybe some minor fluctuations, positive or negative, over the next two or three quarters. And so then we would start to see the effects of our strategy materializing here in nine to 12 months. Does that give you clarity you're looking for?

Yeah, that's great. Thank you very much. Appreciate it.

Yep.

Thank you. The next question is from Paul Knight of KeyBank. Please go ahead.

John, what's the advice CD price today? I mean, lift?

Yes. Hey, Paul. Great to see you. The list price for Advise CTD, and again, this is the PLA code plus an additional 12 to 13 markers. There's one marker there that's on Reflex, so just to be terribly clear, is $1,650. Without Reflex? That drops about $40, so call 1610.

And then based on your experience at other plate diagnostics firms, What do you think the company should operate at as it goes through the process of getting pay or should it be a third list, a half a list? What's your opinion?

My opinion is that we should be operating above our Medicare rate. And under the PAMA legislation, I think the system is designed to either penalize or adjust the rate or reward those who can work through the market dynamic in terms of pricing for their tests. And so that's our goal. That's our objective. And just to give you that number as well, the entire Medicare reimbursed rate is 1,067. So I think we should be operating closer to that level, if not above. And that's what we're working to do.

Do you think more data is needed by commercial payers? What's your opinion what they might be looking for on publications?

I think that we are likely to hear from multiple commercial payers that they will need more data. I think it's up to us to explain why we disagree, and we do disagree with that premise, but that's an easy first objection to throw out there is that the studies that you have are insufficient, are poorly designed, et cetera, et cetera. We have 17 studies covering advised CTD across an advised lupus covering the full spectrum, clinical validity, analytical validity, utility, budget impact in every area. We have real-world evidence that supports the use of the test, and we even have prospective studies showing the patient impact and utility even at a societal level. So I think we have a strong data package. I don't think it will move every payer. Okay. Thank you very much.

Thank you. Ladies and gentlemen, we have reached the end of the question and answer session, and I would like to turn the call back to John and Barney for closing remarks.

Great. We've started 2023 off strong as a team and are seeing initial results from a plan we've put in motion. We've successfully reduced meaningful costs in the organization, driven record demand for advised CETD, and have reshaped our operations in a way which I believe will continue to improve the business going forward. We hope you find the clear articulation of our goals useful in measuring our progress and look forward to updating everyone on future calls. Thank you for your support of Exogen and I sincerely thank the Exogen team for their efforts this past quarter. Thanks for joining the call today.

Thank you very much, Sam. Ladies and gentlemen, that concludes today's conference. You may disconnect your lines at this time.