Good morning, and thank you for standing by. Welcome to NeoGenomics Business Update Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. Please be advised that today's call is being recorded. I will now hand the call over to Kendra Sweeney, Vice President, Investor Relations. Please go ahead.
Thanks, Holly. Good morning, everyone, and welcome. Today, we're joined by Chris Smith, our Chief Executive Officer, Jeff Sherman, Chief Financial Officer, and Ali Olivo, General Counsel and Head of Business Development. Additional members of the team are available for Q&A, including Tim Forshew, Head of Science and Innovation, Dr. Nate Montgomery, Vice President of Medical Services, and Warren Stone, Chief Commercial Officer. Please note that during the call, management will make projections and forward-looking statements within the meanings of federal securities laws regarding future events and the future financial performance of the company. Actual results may differ materially from today's forward-looking statements, depending on a number of factors which are set forth in our public filings with the SEC. I will now pass it over to Chris.
Hey, thanks, Kendra, and welcome, everyone. I appreciate you joining us this morning for an MRD business update. We have received several inquiries from investors, so we wanted to share the latest with the public. As always, I want to first thank our teammates for their commitment to our mission and our vision of saving lives by improving patient care. It will always be at the forefront of all we do. We have stated previously, we are committed to providing patients with comprehensive cancer testing menu that improves patient care and gives patients and providers actionable information. We believe we are a leading oncology lab, in part because of our offering along the cancer care continuum. With that, I'm
excited to announce that we've updated our RaDaR technology, and this updated assay is now through the feasibility stage.
We are proceeding with design and development stage and CLIA validation, which we are targeting for the first half of twenty twenty-five. We believe this new version will be free and clear of IP Natera asserted against the original RaDaR product. It's important to note that the bioinformatics, or our secret sauce, is maintained in this new version. The update in the new version involves modifications to the early steps of DNA processing, which differentiates it from RaDaR 1.0, while retaining the exceptional overall performance. We invested in and later acquired Inivata to expand our offering into the MRD through the RaDaR platform. It wasn't just about a product, it was about a platform, and that first product happened to be RaDaR 1.0, which has exceptional high sensitivity.
The strength of the platform has been and continues to be our proprietary bioinformatics steps, which are protected by a portfolio of patents. The platform was developed by Tim Forshew, who is our Head of Science and Innovation, and Tim is joining us today for Q&A. But Tim and the R&D team have continually iterated on various versions of RaDaR assay with a focus on improving insights for patients and providers. The preliminary injunction brought by Natera forced us to take RaDaR off the market, which we believe was detrimental to patients, which brings me to where we are today. This new test provided us the opportunity to resolve the litigation with Natera as to RaDaR 1.0, and allows us to focus our efforts on advancing that technology, which was always planned for the company going forward.
We decided it's in the best interest of patients and to Neo to accelerate our update through R&D rather than to litigate a version we knew we would retire in the future. That process was already underway, and with the strength of our R&D resources, we were able to accelerate this update in record time. The terms of the settlement with Natera are confidential, but we can confirm that the settlement is not material to Neo's bottom line and does not impact our Adjusted EBITDA guidance range or our liquidity expectations. The resolution of the legal case against RaDaR 1.0 includes Natera no longer asserting the '035 patent against either RaDaR 1.0 or the updated RaDaR product I just mentioned.
The permanent injunction is still subject to carve-outs the court previously addressed, including existing patients in clinical trials, which we believe allows patients to continue with their care without interruption. While Natera claims the updated RaDaR assay may infringe the '454 patent, we disagree and believe the product does not infringe Natera's patent and that the patent is invalid. This case is scheduled to be heard sometime in the second half of next year with a jury trial. We believe the MRD product is one of the most attractive and strategic opportunities in the oncology testing, and that patients deserve to have a choice in testing as the modality becomes increasingly important in delivering personalized care to patients. We are committed to ensuring our patients and customers have access to an MRD product.
As we've shared with you in the past, we are actively pursuing partnership opportunities that will bring us an array of complementary technologies to our RaDaR platform, which we believe could drive new and unique MRD products into the market for years to come. On that, I'm going to go ahead and open up the line for Q&A.
Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two if you would 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, please, while we poll for questions.... Your first question for today is from Dan Brennan with TD Cowen.
Hey, Dan.
Great. Hey, Chris, how are you doing? Thanks for the question here. Maybe the first one would be, I mean, investors kind of waiting in the patents is also, you know, is also. Nonetheless, it would be helpful to- Oh, sorry.
I'm sorry. You broke up, you broke up a bit. That's okay. Just say that last line, that last line.
Yeah, no, I'm just saying, you know, for kind of, you know, looking in the patents is always a difficult endeavor for investors. But I'm wondering if you could help us think about what gives our investors confidence in your stance on the, you know, the version 1.0. Sorry about that. Versus the '454 patent?
Yeah, well, they're two, they're two completely different patents. And the issue, you know, with the injunction was, you know, around the old '035, and that was at the front end, kind of the process. I think from a legal perspective, maybe have Ali give you a little more specifics on that. Ali, do you want to?
Sure. The '454 patent was part of the original case as well, just not the preliminary injunction, and we're not going to reveal our legal strategy. But what we can say is that we believe that we do not infringe. That continues to be the case and that we believe the patent is invalid. We had filed an IPR on the '454 patent, as we previously disclosed. The PTAB did not institute that IPR. It was based on administrative grounds, not substantive grounds. It was a procedural. So, you know, we're going to continue to pursue and defend RaDaR from any claims of infringement.
And then maybe just secondarily, could you give us any color on how we should think about, while it's early, what the performance metrics would look like to the extent you are successful in bringing this version one point one to market versus one point zero, and then ultimately, timing? I mean, just assume you are successful. At what point do you think you'd actually have something in front of Medicare? Is that a year or two away?
I think. Look, so a couple things to think about. I, you know, we, you know, when we acquired Inivata, Tim and the team had multiple versions. And you just like any, any R&D pipeline, they're at different places. And so I would say that, when all this went down with the injunction, we pivoted resources to focus on where the injunction was and to find a way to get that patent resolved and really look for the new products. And so one of the reasons we moved forward with this settlement agreement, as opposed to continuing on that, with that part of the case, was that the new product had gone through feasibility.
So when you think about a timing, you know, that's why we talk about kind of, you know, design, verification and then validation and verification and then CLIA in the first half of next year. So everything follows kind of after that. It's hard to put a time on it, but that's really kind of a point in time that we always look for, is when can we submit to CLIA and when do we get through that part of the R&D process.
Anything on performance that you would suggest? Does the same have the same high level of sensitivity that version one point zero had?
It does. It does. Yeah, that's a really good point. Yeah, it does. So we are still working on two other versions. One in the future, which will be focused much more as sensitivity becomes more and more important. But this was really focused on making sure that the clinical outcomes were similar to the way the, you know, it performs.
Great. All right, I'll get back in the queue. Thank you.
Okay.
Your next question is from Andrew Brackman with William Blair.
Hey, Andrew.
Hi, guys. Hey, Chris, good morning. Thanks for taking the question. I'll stick to one. Chris, in your prepared remarks, you sort of talked about continuing to look at multiple avenues to participate in the, in this MRD market, be that internal or, or even external. I guess, how does this announcement change that strategy or approach? Do you sort of still keep all doors open or just, you know, moving this one forward, sort of close some of the doors?
Yeah. I think it's a really good point. And, look, I think when you look at RaDaR and slash Inivata, I mean, I think it... We had best-in-class R&D, especially around, you know, tumor-informed. And, we still believe that that's the, you know, from a where things are today into the marketplace, the probably the best avenue. That being said, I do believe that there's technologies that are moving in tumor-naive. And I think as, as a company, if we're going to own kind of a comprehensive test menu, kind of the end-to-end, and we want to have customers be able to access the best technology, we think we have to look at things like that.
There is also other ways of getting to, you know, there's multiple technologies that get there, and some focus on turnaround times, some focus on cost, some focus on sensitivity. And so look, we just think it's a big market. As you guys probably know, there's a lot of innovation out there. And so look, while we're not going, you know, we're not going out and looking to do big acquisitions, there are some innovative companies that are looking for a strategic partner that has a very strong distribution channel. And I would say that our distribution channel, especially into the hospital, is best in class, and it's getting better every single day in the community oncology. So that's what. So we just want to be in the MRD space, and we don't think it's one product.
Great. Appreciate the update, guys.
Thanks.
Your next question for today is from Puneet Souda with Leerink.
Yeah. Hi, guys. Thanks.
Hi, Puneet.
So first one, hey, Chris. First one, on the six clinical trials that we're running with the version one, can you just remind us what's the status there? Would they shift over to this new assay? It's usually hard to move over the clinical trials. And then, was that revenue material for work on those clinical trials? And maybe just high level, what is the clinical trial strategy for this V2?
... Yeah, I'm gonna let Ali kind of start with kind of the legal on the, and what we're disclosing publicly, and then I'll let Jeff kind of talk about the revenue stuff. So, Ali, do you wanna start with the six clinical trials and,
Sure.
How we're managing that from a legal?
Yep. Yep, sure thing. So the permanent injunction is still subject to the carve-out the court previously approved as part of the preliminary injunction, so those six clinical trials will continue. So that's gonna allow continued use of RaDaR for existing patients and clinical trials, as well as pharma. And like Chris said, we believe that that allows patients to continue with their care without interruption. As to the revenue, I'm gonna turn it over to Jeff for that one.
Thanks, Ali. Yes, Puneet, so, you know, even before the preliminary injunction, you know, was put forth, we were not expecting RaDaR revenue to really be a significant contributor, in twenty twenty-five. And obviously, with the inability to sell to new clients because of the preliminary injunction, it was even less than we were originally expecting. So it's not really material right now to the company's overall financial performance. We still have revenue, but it's not a big number. It's not material.
Got it. That's helpful. So, my second one is really on clinical evidence, and I'm sure you're gonna run analytical validity and clinical utility studies here. But, you know, the benchmark that one might assess these assays have moved in the marketplace. Sensitivity remains important, but really, you know, there are assays that have a strong data set for adjuvant chemotherapy, indication expansion has happened. And, so just given the state where, you know, where one of the leading competitors in this space is, can you elaborate on, number one, in terms of clinical studies, what are you planning to build clinical evidence here? How does that change your expectations for overall expense this year and into twenty twenty-five?
And then just ultimately, you know, how much of an impact do you think that these studies can make? And it's obviously, it's gonna take some time to do so because you're, you know, there is-
Yeah
... some, a little bit of a time loss that has happened. Thank you.
Yeah. So Puneet, maybe kind of address a couple, and I make sure I try to hit it all because there's a couple... I gotta unpack a couple questions there. But look, I think from a clinical trial perspective, we're huge advocates that we need to have clinical validity of the technology and also outcomes data. And so, you know, we, when we started going down this path, we had ongoing conversations going on with many clinical investigators about trials that we were gonna run specific around disease states. And so I would just say that, we knew that we were this, this is a product that we've been working on. I would say that we pivoted a couple of things.
The reason we're calling it, you know, it said one point zero is the one that was for injunction, but there's multiple products, and so I would say, where you lose time a lot of times with clinical trials is negotiating with investigators and IRBs and things like that, so that has not stopped, and discussions have happened about the product. We haven't disclosed those trials because, candidly, as you can imagine, it's becoming a highly competitive market with MRD, and so we're not gonna put those out till the time is right, but we feel very comfortable with where the clinical movement's going with what we need to be able to support this product in the market, and not only this product, I think the products in the future.
So, I think, oh, as far as, the cost-
Costs.
All those clinical trials are baked into our updated guide that we gave after Q2 for this year, as well as in the long range plan. There will not be. We're not changing our plan. We had already baked all that in.
Got it. Okay. All right. Helpful, guys. Thank you.
Thanks.
Your next question is from Mark Massaro with BTIG.
Hey, guys.
Hey, Mark, how are you?
Hey, this is actually Vivian on for Mark. Thanks for taking the question. So just wanted to check in on how you're weighing the importance of a clinical MRD test, relative to your longer term, I believe it's 10%, revenue target. I think your 2024 guide and long-term guide, both exclude clinical MRD revenue, but I just wanted to confirm that.
Yeah, I'm gonna let Jeff take kind of the guide questions. You want to take that, Jeff?
Sure. You are correct. It did exclude clinical RaDaR. So when we guided last year at our Investor Day, a long-term growth rate of 7%-9%, that excluded clinical MRD RaDaR revenue. And when we updated our guide earlier this year to 10% plus revenue growth, that also excluded any clinical RaDaR revenue. So you are correct that the long-term guide does not include clinical RaDaR revenue.
Okay, great. Thanks for that. And then I think this has kind of been alluded to in the prior questions, but just based on your guys' current understanding, do you need to reapply for Medicare coverage on V2 of RaDaR?
Yeah, look, well, I think when you think about MolDX coverage criteria, you know, look, we'll ensure that we do everything for all tests and test updates, but we're not disclosing kind of our MolDX or Medicare strategy.
Okay, understood. Thanks for taking the questions.
Thanks.
... Your next question is from David Westenberg with Piper Sandler.
Hey, David.
Hi, guys. Hey, Chris. Hope you're doing well. So just one really basic clarification question here. Just on stopping it. I mean, in the press release, it's, you know, it's resolved. So is this like a low-level financial transaction? I mean, can you just give a little bit more clarity on exactly what's happening? And sorry if I'm missing this. I'm not very good at legalese or any kind of thing there. And then just in general, I think always, you know, the key differentiation of RaDaR had always been the low level of detection. So, you know, where do we see the white space in the market? Do you see this as maybe a de-escalation of therapy, specialization?
I'm just kind of thinking about your go-to market strategy, you know, particularly in a sense that this is now, you know, with the new strategy, you might be two or three years later to market than originally thought. So it'd be great to just see-
Yeah
... you know, kind of where that white space is in your mind.
Yeah.
Thank you.
So, I'm gonna unpack that in three ways. I'm gonna take the very last part, and then I'm gonna let Tim and Nate talk from a science perspective. Look, I don't think we are... You know, this piece, without question, we were out marketing a product, and having an injunction and taking it off the market definitely, you know, slowed us down. And I think our team did a incredible job pivoting and continuing the growth because it was still very early days. If you remember back when we were selling, it was not material to the revenue. But all that being said, we had multiple R&D projects going on. And so, I think our pivot to be able to bring this forward has not significantly, really hasn't delayed our version two or three that we were working on.
And so those timelines, so we feel pretty good about where we wanna be, if you look out five years, with where we'll be on the technology. So, while we're not getting into detail about it, I would say that we feel pretty good. I think that, you know, without question, you know, off the market for a certain amount of time with 1.0, but we feel like we'll get back quickly, but it doesn't change the new products. I'm gonna then take your first question, which was around the financials, and I, I'll start with that. If Jeff has something, I'll have Jeff add it, and then I'm gonna turn it over to Nate and Tim. But, you know, as we talked about in the call, so we've reached a settlement.
Like, Look, we made the decision because of the success and how quickly this new product was able to move through feasibility, we made the decision to reach a settlement agreement, and that settlement agreement has no impact on our adjusted EBITDA guidance range, and it doesn't materially change adjusted EBITDA reconciliation or liquidity expectations. So while we're not... You know, the terms are confidential, it, it didn't change it. And, Jeff, I don't know if you wanna add anything on that, and then we'll throw it to Tim and Nate to talk about technology. Yeah, the only thing I would add is, you know, if you look at the adjusted EBITDA reconciliation in our earnings release, you know, it starts with net income or loss, the GAAP number. We don't expect that number to change either.
So really no impact from where we thought we would be when we updated our revised guidance in the second quarter, starting with net income and going all the way down to Adjusted EBITDA. And that's after we raised the guide in Q2, so. All right. I wanna make sure we get around to your question, David. So Tim and Nate, do you guys need him to kind of rephrase some of that, or are you guys good to take that piece of his question? Tim?
I think maybe I perhaps could start with...
That's great, Tim. Thank you.
the white space. I think it's fair. Thanks, Chris. We’ve been, I in particular, working on the RaDaR technology since 2010, and we've continued to look at ways that we can improve the assays in various different ways, and I don't think I can discuss precise details on the call today. But to say that as a team, we continue to look to innovate, and I think there's clearly lots of different ways that we, as a group, have to make tests that become more sensitive, more practical, and I think you'll see these over the coming years. And Nate, I don't know whether you want to add to that.
I think-
I think the only-
I'll let Nate say it clinically.
Yeah. The only... I think the only piece that I would add in, in terms of the opportunity, I agree. RaDaR has, as initially launched, has been an MRD product specifically, right? Certainly, the technologies that drive plasma-based tumor-informed biomarker detection are applicable to other things like dose de-escalation, as the question raised. The technology will guide us. I think we see that we have a really strong technology, and the applications of that, I think, will evolve over time, as the assay comes to market.
Thank you, guys. Okay.
Your next question for today.
Up-
Your next question is from Mike Matson with Needham & Company.
Hey, Mike.
Yeah. Hey, hey, guys. So just, just a quick one on Medicare. I know there was a prior question, but, I mean, is it- does this essentially mean you're gonna have to go back to sort of square one here, or is there any chance that any prior, you know, MolDX submissions would still be applicable?
Yeah, I think I mentioned it earlier. So I think, Look, one of the things, I mean, we're obviously still, you know, we have a court case that's probably gonna hit the docket in the second half of next year. So obviously, we're still in litigation, and we're in a highly competitive market, and we think there are multiple aspects strategically. I think everybody gets into long-term strategy or I just think from our clinical strategy as well as any payer relation strategies, we just feel like that's pretty proprietary because we think we have some innovation there and not gonna kind of put out. But we feel very good about our pathway forward.
Okay, thanks. And then just, it sounds like you're pretty confident that this new version, that there's not gonna be any kinda infringement issues with Natera or anyone else, but I guess what kind of gives you confidence that that is, in fact, the case?
Yeah, that's a little bit of a legal question. Ali, do you wanna take that, without going deep into the technology?
Sure. Obviously, we learned a lot through the preliminary injunction proceedings and subsequent appeal, and so we've taken what we've learned, and this resolution sets us up well for, you know, the next wave of litigation. So it's just basically applying what we've learned without saying too much about our legal strategy.
Okay, got it. Thank you.
Your next question is from Tejas Savant with Morgan Stanley.
Hey, guys.
Hey, Tejas.
Good morning, and appreciate the time here. Chris, can you hear me okay?
Yeah, I can hear you. Thank you.
Perfect. So just a couple of quick cleanups. So first on those carve-outs you mentioned, Chris, is the head and neck carve-out also still in place beyond the ongoing clinical trial that you mentioned? And second, would you consider launching the new version of the assay at risk if you don't have legal clarity on the outcome of that trial in the back half of 2025?
Okay, you broke up that last piece. Can you... I'm sorry, could you say that last piece again?
Yeah, I was just saying, would you consider launching the assay at risk if you don't have clarity on the jury trial outcome in the back half of next year?
Okay, so, let me kinda try to take that a couple of ways. So head and neck is not carved out. Ali can talk kinda more about that. Look, I think for us as a company on launching products, so, you know, we have. Look, when we go through a product launch, there's several steps that you go through, and I think the biggest one is you gotta get through CLIA at the very end of it. And so, you know, the way that we've looked at it is that we wanna make sure that we get through that in the kind of the first half of the year. So we're evaluating as far as market launch. Some of that has to do with what we're gonna do clinically, and also the timing of when we're gonna launch, PanTracer liquid and solid tumor.
So, as we get closer, we'll provide more information, but at this point, I mean, I think our big thing was, is that to be ready to offer the product to the market, you gotta get through the CLIA piece, and then I think we'll tie that in with our clinical strategy. So we're not, we're still evaluating what the optimal launch is gonna be.
Got it. And then just a quick follow-up. I know you said, you know, you're changing the upfront sample processing in the new version of the assay. Can you comment on whether this new version is based on a whole genome sequencing backbone rather than whole exome, like the original version? And, and what are your thoughts in terms of going in that direction down the road, Chris? You know, we've seen Personalis and Myriad, and they've pooled their IP together and so on. So it sounds like that might help you sort of work around that four fifty-four patent.
Yeah. So, I'm gonna let Ali take the legal side. And, Nate, Nate, do you wanna first hit kinda the clinical side of that, and then, Ali?
Sure. So I don't know how much we're saying about the design of the current assay, but I think the point in terms of our long-term vision for RaDaR on exome versus genome. I think we are thinking about, we're going to be in the MRD space, and over time, the technologies that we use to drive tumor-informed and even tumor-naive MRD are probably not going to be singular. And so I may not get into the specifics about the approach that we're taking with the new version of the assay, but in general, I think our approach clinically will not be singular because we see a lot of different clinical issues that we will ultimately want to address with different products.
And do you want to talk about WES also, Tim?
Go ahead, Tim.
Well, I think I can say that for this current product that we're talking about, this initial version will be, it's the same performance as current RaDaR, and so this version will be also based off WES. But to Nate's point, we see an evolution and a very various range of products in future.
Even though we're not talking specifics on the technical differentiators, again, the bioinformatics process is what differentiates RaDaR and has its own patent protection. The difference in this product is an alteration in the early sequencing steps that doesn't affect downstream performance of the test. To your question on Myriad and Personalis and licensing, as Chris talked about in the prepared remarks, we are talking to various partners and others who can leverage our commercial channel, and it is in complementary technologies to the RaDaR platform.
... Got it. Very helpful, guys. Appreciate it.
Your next question is from Mason Carrico with Stephens.
Hey, guys. Just to rehash or get some clarification on some of the previous questions that were asked. So no change to the EBITDA guidance range. So is it fair to assume that there's no material change to how we should think about legal expenses going forward or maybe OpEx in general?
Yeah, Jeff, do you wanna?
Yeah, I would say for twenty twenty-four, you know, there should be really no change in our kind of overall bottom line number or our Adjusted EBITDA number. We haven't talked about twenty twenty-five, but obviously, with the court case, you know, expected to go forward next year, you know, on the other patent, that we'll continue to have some legal expenses. But for twenty twenty-four, our guidance is not changing based upon the terms of the settlement.
Okay.
Or our long-term guide, like that we gave.
Got it.
Yeah.
And then when it comes to prioritization of cancer types for V2, do you plan on initially focusing on the cancer types that V1 already has coverage for, or would this be a different strategy? Any color there?
Yeah. So look, I think it's an interesting point. There are... We've had several studies that have continued in different disease states. So those trials that would get you coverage did have not stopped. And remember that the court case is completely different than Medicare or MolDX in that process. Look, we continue to believe we have a very strong position in all of lung, a strong position in breast, we think, and not just in MRD, but in all our technologies. And I think places where we believe sensitivity is important are the disease states that we'll continue to focus.
Okay. And then I know this has been asked a couple times already, but I mean, maybe based on that statement, is it fair to assume that you believe you may have the ability to leverage some of the work that you've already done related to clinical evidence and reimbursement for V1 shifting over to V2? It's not a complete start from scratch situation.
Yeah, look, I don't, I don't want you guys to speculate on it, but I'm also trying to give you as much information as I can, so I'm just gonna leave kind of the three other people that asked me the way I answered earlier on that.
Okay, fair enough. Thanks.
Yeah. Thanks.
Your next question is from Matt Hewitt with Craig-Hallum.
Good morning.
Hello.
Thanks for taking the questions. Maybe the first one, and I don't know, maybe it's too early to,
Before...
Yeah.
Let me, before you question, let me just kind of finish up that last one with Nate. Look, we're just on as far as coverage. We're very confident in the strategy to secure it, so I'll just leave it at that and move forward. Okay, I'm sorry. Let's go ahead and move forward. Sorry, next.
All right. Thank you. Maybe, and this might be a little bit too early to know, but will the version two point O carry a similar margin expectation, or does the workarounds impact your thoughts on margins?
Yeah, Jeff, I, you want to give specifics on that? Or, I, I mean, pretty much-
Yeah, I would say we don't see any real change in our expected margin profile going forward as a result of the generation we're looking at. You know, most of the cost profile is gonna remain very similar. So, and I would say our expectations on reimbursement, you know, are gonna be pretty similar to our original expectations as well. So I wouldn't think, wouldn't expect there to be any change in our margin profile expectations for the new versions.
Got it. And then I know you've kind of touched on this a couple of times, but with the resolution, and Jeff, this might be a question for you, but with the resolution here, why wouldn't that reduce your legal expense? I realize you still have the ongoing with the, I think it's the '454 and that trial, you know, second half of next year. But with at least a partial resolution, why wouldn't that reduce your legal expense, at least for one piece? Thank you.
Yeah, so I didn't go into specifics regarding legal expenses. We didn't go into specifics regarding legal expenses. What we've said is the settlement is not changing our expectations of our financial performance for this year. And so, I think you can interpret that as you will, but we didn't say our legal fees are gonna be lower or higher for this year. We said the settlement does not change where we expect to finish the year at. And I would say for twenty twenty-five, we haven't given any guidance yet for twenty twenty-five, but we do expect we'll have, you know, legal fees as we look to the court case that's gonna be scheduled for next year.
Understood. Thank you very much.
Thanks.
We have reached the end of the question and answer session, and I will now turn the call over to Chris for closing remarks.
Okay, thanks so much. Hey, everybody, thanks for joining us today. I know we gave prepared remarks, and we definitely wanted to give you some color because a lot of things going on. We're obviously super excited about getting through the feasibility stage with the new product, which allowed us to get this settlement done and get it behind us and really start moving to have this product back on the market. And so we'll continue to keep you updated. Obviously, we'll have an earnings call in several weeks, and if there's any new updates, we'll let you know then. But thanks, everybody, have a wonderful day. Take care.