MDXH
MDxHealthFDocument history
Earnings documents stored for MDXH.
Investor releaseQuarter not tagged2026-08-21MDxHealth (MDXH) Q2 2026 Earnings Call Transcript
Motley Fool
MDxHealth (MDXH) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Chief Executive Officer - Michael McGarrity Interim Chief Financial Officer - Ron Kalfus Operator: Please note this call is being recorded and we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to John Fraunces with LifeSci Advisors. Please go ahead. John Fraunces: Before we begin, I would like to remind everyone that the company will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the Risk Factors section of the company's filings with the Securities and Exchange Commission, specifically in the company's annual report on Form 20-F. I will now turn the call over to Michael McGarrity, Chief Executive Officer. Michael McGarrity: Thanks, John, and thank you all for joining us for our second quarter 2026 earnings conference call. With me today is Ron Kalfus, Interim Chief Financial Officer. Q2 was a pivotal quarter for MDxHealth. Following the unanticipated reimbursement developments related to our Resolve test in April, our Q2 results reflect the strength of our core business, which was precisely what we committed to deliver with our sales force focused solely on this significant market opportunity. More specifically, we communicated that we expected sequential revenue acceleration from Q1 to Q2. We generated a 14% sequential revenue increase, or $3.3 million, representing the largest quarter-over-quarter revenue acceleration in our company's history. We also anticipated a recovery in our tissue-based business following the expected impact in Q4 and Q1 post-integration and sales force restructuring from the ExoDx acquisition. We delivered that recovery with a sequential increase of greater than 1,400 tissue-based tests. We aggressively set a goal to transition all of our Resolve customers by the end of Q2, an objective that we achieved while also building deep credibility with our customer base through the unwavering dedication and support of our sales and client services teams. Based on our revenue growth expectations, coupled with exceptional operating discipline, we are now firmly on track to return to positive adjusted EBITDA as we exit 2026. Following th…Read full documentShow less
Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Chief Executive Officer - Michael McGarrity Interim Chief Financial Officer - Ron Kalfus Operator: Please note this call is being recorded and we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to John Fraunces with LifeSci Advisors. Please go ahead. John Fraunces: Before we begin, I would like to remind everyone that the company will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the Risk Factors section of the company's filings with the Securities and Exchange Commission, specifically in the company's annual report on Form 20-F. I will now turn the call over to Michael McGarrity, Chief Executive Officer. Michael McGarrity: Thanks, John, and thank you all for joining us for our second quarter 2026 earnings conference call. With me today is Ron Kalfus, Interim Chief Financial Officer. Q2 was a pivotal quarter for MDxHealth. Following the unanticipated reimbursement developments related to our Resolve test in April, our Q2 results reflect the strength of our core business, which was precisely what we committed to deliver with our sales force focused solely on this significant market opportunity. More specifically, we communicated that we expected sequential revenue acceleration from Q1 to Q2. We generated a 14% sequential revenue increase, or $3.3 million, representing the largest quarter-over-quarter revenue acceleration in our company's history. We also anticipated a recovery in our tissue-based business following the expected impact in Q4 and Q1 post-integration and sales force restructuring from the ExoDx acquisition. We delivered that recovery with a sequential increase of greater than 1,400 tissue-based tests. We aggressively set a goal to transition all of our Resolve customers by the end of Q2, an objective that we achieved while also building deep credibility with our customer base through the unwavering dedication and support of our sales and client services teams. Based on our revenue growth expectations, coupled with exceptional operating discipline, we are now firmly on track to return to positive adjusted EBITDA as we exit 2026. Following the discontinuation of Resolve UTI testing, we completed the cessation of our Plano, Texas, lab operations and eliminated the $10.4 million contingent liability to Novitas from our corporate structure as a discontinued operation through an organized wind down of that independently operated entity. Finally, we strengthened our balance sheet and cash position through a registered direct financing that generated $20 million in proceeds priced at the market with no discount or warrant structure. I want to express my sincere gratitude to our entire organization for their professionalism and perseverance over these challenging 90 days. In my experience, you are defined not by what happens to you, but by how you respond. Our entire team, from sales and client services through revenue cycle management and laboratory operations, demonstrated incredible character, professionalism, and commitment to our customers and to each other. I am immensely proud to stand alongside such a resilient group of professionals who stepped up when it mattered most. I would also like to specifically thank our Plano, Texas, team for their unwavering commitment to serving our customers through their final day of operations on June 30th. Their professionalism and dedication to our patients was extraordinary, and our entire organization owes them a debt of gratitude for their integrity and service. This company did not suddenly forget how to operate and execute. While our operational strength was clearly on display in Q2, we are confident that our growth trajectory will return to the performance we have consistently delivered over the last number of years as we move through the remainder of 2026 and beyond. This confidence is rooted in our high-growth market opportunity, our strong competitive position, and our unparalleled suite of clinically actionable diagnostics, supporting clinicians and patients across the entire prostate cancer continuum. Our foundational commitment to focus, execution, and growth has never been more evident than during our navigation of Q2, and we look forward to continuing that momentum. Before turning the call over to Ron, I want to thank our shareholders who stepped up to support our mission, as well as our customers and stakeholders for their continued trust and confidence in MDxHealth. We are incredibly proud of our team's commitment not only to our operational and financial performance, but to what matters most, the patient and family on the other side of every single sample we receive. I will follow up with some closing comments and view forward, but first, let me turn the call over to Ron to walk through our second quarter financial results. Ron? Ron Kalfus: Thank you, Mike. Before I dive into the financial results, I want to briefly frame our Q2 presentation. As detailed in our press release, we have successfully completed the wind-down of our Resolve UTI business in Q2 with the permanent cessation of operations of our Delta Laboratories subsidiary and its Plano, Texas laboratory prior to June 30, 2026. Having met the requisite accounting criteria, the Resolve business is now formally classified as a discontinued operation. As such, all current and prior year financial metrics reflect only our continuing core operations with the historical results of the Resolve business fully excluded. Our revenue for the second quarter ended June 30, 2026 was $27.2 million, an increase of 16% over the second quarter of 2025. Revenue in the second quarter of 2026 was comprised of 73% from tissue-based tests, compared to 96% for the same period last year. Moving below the revenue line, our gross profit for the quarter was $17.9 million, an increase of 11% as compared to $16.1 million for the second quarter of 2025. Gross margins were 65.7% compared to 68.6% for Q2 2025, a decrease of 2.9 percentage points, primarily attributed to tissue versus liquid mix. Our operating loss for the quarter increased to $5.1 million, compared to $1.5 million for the second quarter of 2025, primarily driven by increases in headcount and other OpEx related to the ExoDx acquisition, which were not present at this time last year. Our net loss increased 36% to $9.5 million, compared to $7 million for the prior year, primarily driven by OpEx related to the ExoDx acquisition. We are confident that our guidance and associated revenue growth will absorb this increase in acquired OpEx and return to our trend of adjusted EBITDA profitability as we exit this year. Adjusted EBITDA for the second quarter was a negative $2.3 million, compared to a positive $1.1 million for the second quarter of 2025. Note that a reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. Finally, cash and cash equivalents as of June 30, 2026, total $19.2 million. In addition, on August 11, we executed a $20 million registered direct placement with existing shareholders. After taking this transaction into account, our pro forma cash balance as of June 30, 2026, would have been $39.2 million. This concludes my overview of the financial results, and I will now turn the call back to Mike. Michael McGarrity: Thanks, Ron. When speaking with stakeholders following our Q1 results, I noted that while the decision to discontinue Resolve was unfortunate, I believed it would likely end up being a blessing in disguise, one that would manifest as an absolute singular focus on the vertical we have built in the urology market and our prostate cancer franchise in particular. Our Q2 performance represents the first clear evidence of that promise and potential being realized. From a focus perspective, the peer-reviewed publication of data from our Oxford ProMPT study is already being recognized and embraced by our urology customers. Furthermore, we see clear visibility into the potential of our landmark Oxford ProtecT study to transform the market landscape, particularly for patients in the active surveillance setting. Our vision is to establish GPS as the only diagnostic test with NCCN level 1 evidence in this critical patient population, which represents the majority of patients in the prostate cancer diagnostic pathway. Additionally, we continue to advance our AI initiatives, which will deliver meaningful incremental value to both new and existing customers across our urology and pathology stakeholders. Over the past two years, our efforts to establish and expand our reach with pathology partners alongside the urologists they serve have paid significant dividends. We are confident that both Confirm and GPS will continue to resonate strongly with this key constituency through their unique clinical features, benefits, and supporting data. All of this progress in Q2 reinforces our commitment to and confidence in meeting or exceeding our full year guidance of $110 million-$115 million in revenue while returning to adjusted EBITDA profitability as we exit this year. Our culture of quality first and customers always continues to drive our growing reputation for excellence across the urology market. We remain steadfast in our commitment to delivering growth and value, cementing MDxHealth's position as the leading precision diagnostics company focused exclusively on our high-growth urology market opportunity. As always, we carry a profound responsibility to create long-term value for all of our stakeholders, including patients, clinicians, payers, and shareholders. Thank you for your continued interest in and support of MDxHealth. I will now turn the call back over to the operator to open the line for questions. Operator: Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. We'll take our first question from Thomas Flaten with Lake Street. Your line is open. Thomas Flaten: Hey, Mike and Ron. Congrats on a nice rebound quarter. Two questions from me. Given the sequential increase on the tissue side, do you think we can conclude that the challenges were internal rather than there being any competitive dynamics that were impacting volumes previously? Michael McGarrity: Yeah, Thomas. I think we were ahead of that a little bit. I kind of signaled we expected Q4 and Q1 to be a little choppy, really a function of the restructuring of the sales organization. We had a territory reorganization and then cross-training of the new reps, remapping of the customer base, the combined businesses, and that's really what we saw. We didn't see it in, hopefully Q2 is the beginning of evidence of that it would disrupt our position in the market. Just more create a little diversion of the focus for that quarter or two and we're confident that Q2 signals that we're back to the full sales force focused on our core menu. Thomas Flaten: Excellent. Then as we go from first half to second half towards your guidance range, do you expect the revenue progression to be pretty linear, or should we expect some type of fluctuation between Q3 and Q4? Michael McGarrity: Yeah, Thomas, I would say generally linear. Q3 is always a little bit of a wild card with some seasonality just based on patients and clinician flow through our urology customer base. So that being the only potential factor to affect Q3, we would expect acceleration in Q3 and Q4 in linear-ish. Thomas Flaten: Great. I appreciate that. Thank you. Michael McGarrity: Thanks, Thomas. Operator: We'll take our next question from Dan Brennan with TD Cowen. Your line is open. Dan Brennan: Hey, guys. Thanks for the questions. Maybe just the first one, it's nice to hear that liability, I think that was there from the Texas Medical case, is off the books now, I guess, because you closed the lab. Just wanted to confirm, I guess. Did you guys discuss that at 1Q, like this ability to remove that given these actions? Because it sounds like it's a nice removal on your part. Michael McGarrity: Yeah, Dan, thanks. I didn't want to get ahead of that. There was obviously a lot of work to occur with all of our outside counsels and advisors on setting that up and consent from our lending partner, but it came together as we anticipated. We believed the structure, the way we set that entity up allowed for that. We just wanted to make sure that we had it all tight, and we were able to close that up here for this communication. So we believe that is a significant de-risking element to our business as we go forward. Dan Brennan: Good stuff. Then the raise, obviously getting it done at the market, it was attractive. Just wondering, can you speak to a little bit how that sets you up? Obviously, your adjusted EBITDA positive exiting the year, which is nice to hear. You have this $20 million of additional capital. As we look ahead, I know you've got the debt, and you have some payments from Exact still out the next couple of years. Just how do we think about the need for further capital versus internally generated cash flow? Michael McGarrity: Yeah, I think your last statement is key, right? We anticipate that based on the scale of our business and the leverage we have in the P&L, one of the key execution items we've focused on is significant and consistent top-line growth while holding our OpEx really straight away for the past three years. We expect both those to continue, and that leverage generates meaningful progress in the business beginning to fund itself from an operating basis. We're confident that gives us pretty strong leverage as we go forward. This capital, our balance sheet position, obviously provides significant runway for the business. And we've demonstrated, I think, with our partner, Exact, Abbott, flexibility on that. All those options remain in front of us, but the two key points, and also the equity option on that, they are stakeholders in the company as well. We're really counting on the business progress growth continuing that really begins to fund some of those obligations. But we have clear runway through that period right now. Dan Brennan: Terrific. Okay, guys. Thanks a lot. Michael McGarrity: Thank you, Dan. Operator: We'll take our next question from Bill Bonello with Craig-Hallum. Your line is open. Bill Bonello: Hey, guys. Thanks a lot. I want to circle back on a couple of the topics that have been talked about. I guess first again on tissue. It was great to see the sequential increase, but it looks like volume's still down on a year-over-year basis, yet competitors still growing in the mid-teens. You did have one competitor talk about weakness in the low-risk segment of the market. However, I guess I'm just trying to get a sense of if things are sort of back to functioning on the sales force front without distraction, not destruction, why wouldn't we think of that being a business that should be growing faster year-over-year? I know you talked about acceleration, but maybe give us some sense of what you think the potential is for that business in a more normalized year-over-year growth. Michael McGarrity: Yeah, Bill, I absolutely get the question. I think, at the risk of pointing to a comp, Q2 of last year was our highest tissue-based quarter. I don't want to lean too much on that. I think one other note of Q2, when I commented with Thomas on tissue in Q4 and Q1, Q2, one of the things that I was, I don't want to say concerned about, but required a lot of focus was our sales organization also in a six week period in the back half of the quarter, had to focus on transitioning all of our Resolve customers. While we didn't disclose the number, that was hundreds of customers and thousands of urologists that were using that test. So that lift was significant, probably equal to or more than the restructuring of the sales organization based on the time. They completed that with all of our customers being successfully transitioned to their acceptance while driving that sequential acceleration. I get it, the flat year-over-year, we're not celebrating that on a go-forward basis, but our guidance as it's set up requires a return to year-over-year growth that we were seeing prior to this. Our current guide at $110 million-$115 million contemplates 20%-26% growth, which would suggest that if you look at our 2026 for tissue by quarters, we'd be down 12 flat, and then up accelerated. I guess hopefully that's a fair answer that we expect as we post and discuss Q3 and post and discuss Q4. We would agree, we do think our position in that lower risk category, the active surveillance population we reference, is really gaining strength, and we'll continue to count on that. That's what our sales force will be focused on. I give a lot of credit to the team for doing two things at once, right? Driving the recovery in the business and taking care of all those customers. It's important to note, virtually all of those Resolve customers are prostate cancer customers. So it required real focus and goodwill working with our customers to obviously not upset our base, and we think we successfully achieved that. Bill Bonello: That's helpful. Just to be crystal clear, because as we thought through the implications for you in low risk, we sort of could have envisioned one of two scenarios. One, you're seeing similar maybe macro level decline in utilization, or two, you're taking share. It sounds like from your answer, you're not necessarily seeing any kind of headwind in terms of utilization. Is that fair, or I'm putting words in your mouth? Michael McGarrity: No, I think that's fair. When we refer to our growth on the tissue side, particularly with GPS, I often reference two drivers of growth. One is market conversion. In other words, still, Bill, as you know, a significant part of that market opportunity is there for urologists that do not currently use biomarker testing in the active surveillance population and share. I think our growth trajectory over the past couple of years has been driven by both, and we expect that to continue. So it's kind of comparing to the two competitors in that space and how they report, it's a combination of are we taking share from them or are we converting the market? I think the ProMPT data today and the ProtecT data ultimately really help with both. But particularly on that conversion side, hopefully that holds together for you. But that's an important point that we see as the opportunity. Bill Bonello: That's super helpful. Just one last one. Is it possible to give us any sense of what the liquid volume growth looked like on a pro forma basis so that we have some sense of what the underlying, because obviously big boost from the acquisition, but so we have some sense of what the underlying growth is? Michael McGarrity: I'm not sure I. Go ahead. Ron Kalfus: Bill, I don't think we can because pro forma would be comparing Exo to Select, but we stopped selling Select mdx, so we can't really compare one to the other. It's not like we're selling bulk entirely. Bill Bonello: I was trying to think of Exo last year versus Exo this year. Michael McGarrity: Oh, I see. Bill Bonello: To get that picture. Michael McGarrity: Yeah. I get it now. Yeah, we're not doing that. It wasn't our as-reported numbers, but we're confident that we'll be continuing to drive growth into the Exo product line. Really, again, with the integration, we're a couple quarters in. The majority of the Exo business that began to be covered by us was covered by legacy MDxHealth reps. We're confident that this is really the quarter where we begin to see that, and Q4 will be the first where we have actual year-over-year comps for a quarter on an Exo volume. Bill Bonello: Okay. Thank you very much. Michael McGarrity: Thank you, Bill. Operator: We'll take our next question from Mark Massaro with BTIG U.S. Bank. Your line is open. Mark Massaro: Hey, guys. Thank you for taking the questions. Since we are in the month of August, and we're tidying up our models, I was wondering if you could react to your confidence in perhaps growing 20% in 2027. And if you could just walk us through some of the puts and takes as to how you're thinking about the next full year. Michael McGarrity: Sure, Mark. Probably premature to provide visibility to guidance for 2027, but I get the question. We think that there is significant opportunity for growth with the Exo business as we go forward. Then on the tissue side, I will provide more detail around our AI initiative there as well, which obviously would drive largely GPS. But we are very confident that can and will begin to contribute in 2027. Then the third arm of that would be the ProMPT data in the active surveillance population. When you look at the data from that peer-reviewed publication, we expect it to mirror what will come out in the landmark ProtecT. I think our urologists today are noting that. That coupled with the AI initiatives we have going that we would expect to be supportive as we come out of this year and the next. We think we will have a basis to provide good growth trajectory 2027 and beyond. Mark Massaro: That is super helpful. Congrats on the raise, I guess. As Dan Brennan mentioned, you do have some puts and takes with the balance sheet. But I wanted to get a sense for, in recent years, you have brought in some assets and now you have divested some assets. How are you thinking about the portfolio going forward? I know you are talking about some internal development. With the $20 million of cash coming in, how are you thinking about exploring potential tuck-ins? I know in the past you have been able to bolt on things at really rational and reasonable valuations. I am just curious how you are thinking about the potential for inorganic growth from here. Michael McGarrity: Yeah, I guess I would answer that two ways. One, per your previous question and hopefully my answer, we are very positive and confident on our current market opportunity. We believe it can support our growth for the foreseeable future based on our initiatives, our discipline on the operating side, and our sales force execution. That said, we are a growth company. I think I have shared with you and everybody that we run a growth strategy process here. We are always looking out. I would say that is flipped significantly where I think, and please take this the right way, it is not meant to be self-serving, but anybody who is looking for partner or opportunity or channel or infrastructure into the urology vertical, we are an obvious first stop. I want to be careful here. I think you and I want to discuss don't get too far ahead with potential opportunities for growth, but we'll be very disciplined as we have in the past. For right now, in the near term for sure, we are focused on execution of the opportunity we have in front of us in clearing what I said this Resolve development was probably a two to three quarter setback from our previous trajectory. We've got one quarter posted. We look forward to posting Q3 and Q4, and then I think 2027 and beyond comes more clear, and then we can revisit how we think about growth. Definitely opportunities there. We just want to be disciplined. Mark Massaro: That makes perfect sense. If I can squeeze one more in. I wanted to ask, some of the other lab testing companies have seen benefits from revenue cycle management initiatives, collecting claims from prior periods, and other companies have been winning some additional commercial payer coverage and the like. I know there's a lot of focus on volume growth, but I just wanted to get a sense for is there any juice to squeeze on the ASP side? Michael McGarrity: Well, as I think you know, but just to be clear, our projections, the way we build our model is based on our expectation of unit growth, but we view our market access managed care team and our RCM team as productivity engines for the business as well. While I'm not guiding to pick up there, I think we've seen stability in our ASPs, and I guess based on some of the dynamics in the reimbursement landscape across the industry, unrelated to Resolve, but just in general, we're confident that we've got good discipline there. Yeah, we consistently The data helps, Mark, as you know. I think when you look at some of the initiatives that we have, even our AI initiatives, there's some opportunity there from both the ProMPT ProtecT as well as the way we'll end up positioning our AI to support that aspect of our business, but nothing to project to right now. Mark Massaro: That sounds good. Thanks for the time. Michael McGarrity: Thank you, Mark. Operator: Once again, for your questions, that is star one. We'll move next to Matt Larew with William Blair. Your line is open. Matt Larew: Hi, good afternoon. Mike, you've referenced both last quarter and this quarter the notion sort of a blessing in disguise, and you've also last quarter made quite a bit of progress on the Exo integration. Certainly, the sequential improvement in revenue maybe is the obvious KPI that would be a mark of that. But just curious in terms of other internal KPIs, whether it's sales force productivity, account touchpoint utilization, anything else that you're seeing underneath the hood that suggests to you those things are moving in the right direction and perhaps that's what's giving you additional confidence on the ramp of the back half of the year? Michael McGarrity: Yeah. Matt, I think there's nothing we don't metric and measure here with regard to the way our business builds our opportunity. I don't want to disclose all those, but we look at everything from the way our physicians adopt our menu with the goal of selling our full pathway solution to the way they adopt within a large group practice. In other words, you get a few of them to buy into our pathway in a reliable way where it's internally we call it compliance to our pathway. The other component to it is what I noted in my prepared comments, which is the influence and impact of pathology, which really has made a difference. I'll just be brief here, but there's a couple features of GPS in particular that really resonate with pathology, right? It requires significantly less tissue than the two competing tests. Once pathology understands the value of Confirm that it's not proving a pathology read was wrong, it's the limitations of biopsy. All those things work with what we track to say, "Yeah, we're getting pick-up here. It's sustainable, it's sticky," and it helps actually create the model for our sales organization, our medical science liaison team. We have pathology supporting our resources that all work together to give us the data that suggests really helps us build our model and definitely our forecast as we go through this year. Matt Larew: Okay. Thanks. Then just on ProtecT, just sort of the way you described it today, the notion of clear visibility into that, just wondering if there's anything that you're seeing that's giving you more confidence. I think that is reading out early next year, but I guess maybe just confirm that's still the timeline, and what you anticipate the response might be from the physician community once you get that out there. Michael McGarrity: Yeah. I think I've hesitated to give timelines there, but what I would say is our clinical scientific affairs team works directly with Oxford. We have consistent regular updates with them. They're almost a project management team coupled with our CSA and project management teams working in collaboration. So it gives us confidence every month that we're making progress there. It's difficult to handicap the timing of the readout, and then the secondary benefit would be the guideline work that we'll do on the other side of that. So based on our KOL network that group has established, our somewhat influencer reach into the NCCN, and the reputation and sway of Dr. Hamby and the Oxford team, that gives us our confidence. Each quarter, I'll provide Matt better visibility as to how we think that comes timing-wise. I think the last comment I will make on that is that getting the ProMPT published in a peer-reviewed manner does provide really good foundational view of this is what we expected. This is what they somewhat mandated that we do the ProMPT first before they turn on the ProtecT cohort, which is the most valuable one in the world. In hindsight, that was the right thing to do because it gave us confidence, them confidence, that GPS was and is the right test to prove that out. Matt Larew: Okay. Thank you. Michael McGarrity: Thank you, Matt. Operator: It does appear that there are no further questions at this time. Thank you. This brings us to the end of today's meeting. We appreciate your time and participation, and you may now disconnect. Before you buy stock in MDxHealth, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and MDxHealth wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $432,621!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,314!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 20, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. MDxHealth (MDXH) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-08-14MDxHealth S.A. Q2 2026 Earnings Call Summary
Moby
MDxHealth S.A. Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved a 14% sequential revenue increase, representing the largest quarter-over-quarter acceleration in company history, driven by a singular focus on the core urology and prostate cancer franchise. Successfully transitioned the entire Resolve UTI customer base by the end of Q2, maintaining deep credibility with urologists while exiting the non-core business. Delivered a recovery in the tissue-based business with a sequential increase of over 1,400 tests, overcoming previous integration and sales force restructuring headwinds from the ExoDx acquisition. Attributed the Q2 performance to the resilience of the sales and client services teams who managed a significant customer transition while simultaneously driving core volume growth. Strengthened the competitive position of the Genomic Prostate Score (GPS) through peer-reviewed data from the Oxford ProMPT study, which resonates with urologists in the active surveillance setting. Leveraged pathology partnerships to drive adoption of Confirm and GPS, utilizing unique clinical features like lower tissue requirements to differentiate from competitors. Maintained strict operating discipline, holding operating expenses relatively flat over three years to maximize P&L leverage as top-line revenue scales. Reiterated full-year 2026 revenue guidance of $110 million to $115 million, implying a return to year-over-year growth in the second half of the year. Firmly on track to return to positive adjusted EBITDA as the company exits 2026, supported by revenue growth and the removal of legacy liabilities. Anticipates the landmark Oxford ProtecT study will establish GPS as the only diagnostic test with NCCN Level 1 evidence for the active surveillance patient population. Advancing AI initiatives expected to deliver incremental value to urology and pathology stakeholders starting in 2027. Expects revenue progression through the remainder of 2026 to be generally linear, with potential for typical Q3 seasonality in patient and clinician flow. Classified the Resolve UTI business as a discontinued operation following the permanent cessation of Plano, Texas, laboratory operations on June 30, 2026. Eliminated a $10.4 million contingent liability to Novitas through the organized wi…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved a 14% sequential revenue increase, representing the largest quarter-over-quarter acceleration in company history, driven by a singular focus on the core urology and prostate cancer franchise. Successfully transitioned the entire Resolve UTI customer base by the end of Q2, maintaining deep credibility with urologists while exiting the non-core business. Delivered a recovery in the tissue-based business with a sequential increase of over 1,400 tests, overcoming previous integration and sales force restructuring headwinds from the ExoDx acquisition. Attributed the Q2 performance to the resilience of the sales and client services teams who managed a significant customer transition while simultaneously driving core volume growth. Strengthened the competitive position of the Genomic Prostate Score (GPS) through peer-reviewed data from the Oxford ProMPT study, which resonates with urologists in the active surveillance setting. Leveraged pathology partnerships to drive adoption of Confirm and GPS, utilizing unique clinical features like lower tissue requirements to differentiate from competitors. Maintained strict operating discipline, holding operating expenses relatively flat over three years to maximize P&L leverage as top-line revenue scales. Reiterated full-year 2026 revenue guidance of $110 million to $115 million, implying a return to year-over-year growth in the second half of the year. Firmly on track to return to positive adjusted EBITDA as the company exits 2026, supported by revenue growth and the removal of legacy liabilities. Anticipates the landmark Oxford ProtecT study will establish GPS as the only diagnostic test with NCCN Level 1 evidence for the active surveillance patient population. Advancing AI initiatives expected to deliver incremental value to urology and pathology stakeholders starting in 2027. Expects revenue progression through the remainder of 2026 to be generally linear, with potential for typical Q3 seasonality in patient and clinician flow. Classified the Resolve UTI business as a discontinued operation following the permanent cessation of Plano, Texas, laboratory operations on June 30, 2026. Eliminated a $10.4 million contingent liability to Novitas through the organized wind-down of the Delta Laboratories subsidiary, significantly de-risking the corporate structure. Strengthened the balance sheet via a $20 million registered direct financing priced at market with no discount or warrants, providing a pro forma cash balance of $39.2 million. Gross margins decreased 2.9 percentage points to 65.7% due to a shift in product mix between tissue-based and liquid-based tests. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that previous volume choppiness was due to internal territory reorganization and cross-training rather than competitive losses. Confirmed the sales force is now fully focused on the core menu after completing the 'significant lift' of transitioning Resolve customers. Management noted they are not seeing macro headwinds in the low-risk category and believe they are gaining strength in the active surveillance population. Growth is being driven by a combination of market conversion (targeting clinicians not currently using biomarkers) and taking share from competitors. Stated that the current cash position and projected EBITDA profitability provide a clear runway to fund future obligations, including payments to Exact Sciences. Indicated that while the business is focused on organic execution, they remain open to disciplined inorganic growth opportunities given their strong urology channel. Confirmed consistent progress with Oxford partners but declined to provide a specific readout date, citing the complexity of clinical timelines. Emphasized that the ProMPT publication was a necessary precursor that validated GPS as the correct test for the more valuable ProtecT cohort.
Investor releaseQuarter not tagged2026-08-14MDxHealth SA (MDXH) (Q2 2026) Earnings Call Highlights: Record Sequential Growth and Strategic ...
GuruFocus.com
MDxHealth SA (MDXH) (Q2 2026) Earnings Call Highlights: Record Sequential Growth and Strategic ...
This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MDxHealth SA (NASDAQ:MDXH) delivered a 14% sequential revenue increase in Q2 2026, the largest quarter-over-quarter acceleration in company history. The company successfully transitioned all Resolve customers by the end of Q2, maintaining customer relationships and building credibility. MDxHealth SA (NASDAQ:MDXH) eliminated a $10.4 million contingent liability to Novitas by winding down its Plano, Texas lab operations. The company strengthened its balance sheet with a $20 million registered direct financing at market price with no discount or warrants. Management reaffirmed full-year 2026 revenue guidance of $110 million to $115 million and expects to return to positive adjusted EBITDA by year-end. Gross margins decreased by 2.9 percentage points year-over-year to 65.7%, primarily due to a shift in product mix toward liquid-based tests. Operating loss widened to $5.1 million in Q2 2026, compared to a $1.5 million loss in the prior year period, driven by ExoDx acquisition costs. Net loss increased 36% year-over-year to $9.5 million, reflecting higher operating expenses from the ExoDx acquisition. Adjusted EBITDA turned negative at -$2.3 million in Q2 2026, versus a positive $1.1 million in Q2 2025. Tissue-based test volumes remained flat year-over-year, with management acknowledging the need to return to prior growth rates to meet guidance. Warning! GuruFocus has detected 5 Warning Signs with MDXH. Is MDXH fairly valued? Test your thesis with our free DCF calculator. Q: Given the sequential increase on the tissue side, do you think we can conclude that the challenges were internal rather than there being any competitive dynamics that were impacting volumes previously? A: CEO Michael McGarrity confirmed the challenges were internal, stemming from the restructuring of the sales organization post-ExoDx acquisition, including territory reorganization, cross-training of new reps, and remapping of the customer base. He noted Q2 signals that the full sales force is now focused on the core menu, indicating a return to normal operations. Q: As we go from first half to second-half toward your guidance range, do you expect the revenue progression to be pretty linear or should we expect some type of f…Read full documentShow less
This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MDxHealth SA (NASDAQ:MDXH) delivered a 14% sequential revenue increase in Q2 2026, the largest quarter-over-quarter acceleration in company history. The company successfully transitioned all Resolve customers by the end of Q2, maintaining customer relationships and building credibility. MDxHealth SA (NASDAQ:MDXH) eliminated a $10.4 million contingent liability to Novitas by winding down its Plano, Texas lab operations. The company strengthened its balance sheet with a $20 million registered direct financing at market price with no discount or warrants. Management reaffirmed full-year 2026 revenue guidance of $110 million to $115 million and expects to return to positive adjusted EBITDA by year-end. Gross margins decreased by 2.9 percentage points year-over-year to 65.7%, primarily due to a shift in product mix toward liquid-based tests. Operating loss widened to $5.1 million in Q2 2026, compared to a $1.5 million loss in the prior year period, driven by ExoDx acquisition costs. Net loss increased 36% year-over-year to $9.5 million, reflecting higher operating expenses from the ExoDx acquisition. Adjusted EBITDA turned negative at -$2.3 million in Q2 2026, versus a positive $1.1 million in Q2 2025. Tissue-based test volumes remained flat year-over-year, with management acknowledging the need to return to prior growth rates to meet guidance. Warning! GuruFocus has detected 5 Warning Signs with MDXH. Is MDXH fairly valued? Test your thesis with our free DCF calculator. Q: Given the sequential increase on the tissue side, do you think we can conclude that the challenges were internal rather than there being any competitive dynamics that were impacting volumes previously? A: CEO Michael McGarrity confirmed the challenges were internal, stemming from the restructuring of the sales organization post-ExoDx acquisition, including territory reorganization, cross-training of new reps, and remapping of the customer base. He noted Q2 signals that the full sales force is now focused on the core menu, indicating a return to normal operations. Q: As we go from first half to second-half toward your guidance range, do you expect the revenue progression to be pretty linear or should we expect some type of fluctuation between Q3 and Q4? A: CEO Michael McGarrity stated that revenue progression should be generally linear, with Q3 potentially affected by seasonality based on patient and clinician flow. He expects acceleration in both Q3 and Q4, maintaining a linear-ish trajectory. Q: It's nice to hear that liability from the Texas Medicaid case is off the books now because you closed the lab. Can you confirm that and speak to how the $20 million raise sets you up for future capital needs versus internally generated cash flow? A: CEO Michael McGarrity confirmed the elimination of the $10.4 million contingent liability to Novitas through the organized wind-down of the Plano, Texas lab, calling it a significant de-risking element. CFO Ron Kalfus added that with the $20 million registered direct placement, pro forma cash is $39.2 million, providing significant runway. McGarrity emphasized that continued top-line growth with flat OpEx will allow the business to begin funding itself, reducing the need for further capital. Q: It's great to see the sequential increase, but it looks like volume is still down on a year-over-year basis, and competitors are still growing in the mid-teens. Why wouldn't we think of that as a business that should be growing faster year over year? A: CEO Michael McGarrity acknowledged the flat year-over-year tissue performance but attributed it to the Q2 2025 high comp and the significant effort required to transition hundreds of Resolve customers and thousands of urologists during the quarter. He reiterated full-year guidance of $110-$115 million, implying 20%-26% growth, which requires a return to prior year-over-year growth rates in the back half, with expectations of being down 12% in Q1, flat in Q2, and accelerated in Q3 and Q4. Q: Were you seeing any kind of headwind in terms of utilization in the low-risk segment, or are you taking share? A: CEO Michael McGarrity clarified that growth is driven by two factors: market conversion (urologists not currently using biomarker testing in active surveillance) and share gains. He cited the Oxford PROMT data and upcoming PROTECT study as key drivers for both, particularly for market conversion, and expressed confidence in the company's position in the lower-risk category. Q: Is it possible to give us any sense of what the liquid volume growth will look like on a pro forma basis, comparing ExoDx last year versus this year? A: CFO Ron Kalfus noted they cannot provide pro forma comparisons because they stopped selling SelectDx, making a direct comparison impossible. CEO Michael McGarrity added that they are confident in driving growth into the ExoDx product line, with Q4 2026 being the first quarter with actual year-over-year comps for ExoDx volume. Q: Can you react to your confidence in perhaps growing 20% in 2027, and walk us through some of the puts and takes for the next full year? A: CEO Michael McGarrity said it's premature to provide 2027 guidance but expressed confidence in significant growth opportunities from the ExoDx business, AI initiatives driving GPS, and the PROMT data in the active surveillance population. He expects these factors to support a good growth trajectory in 2027 and beyond, with more clarity after posting Q3 and Q4 results. Q: With the $20 million of cash coming in, how are you thinking about exploring potential tuck-in acquisitions or inorganic growth from here? A: CEO Michael McGarrity emphasized a disciplined approach, stating the current market opportunity can support growth for the foreseeable future. He noted that MDxHealth is an obvious first stop for partners looking to enter the urology vertical, but for the near term, the focus is on executing the existing opportunity and clearing the two-to-three quarter setback from the Resolve discontinuation before revisiting growth strategies. Q: Is there any juice to squeeze on the ASP side, given other lab testing companies have seen benefits from revenue cycle management initiatives and commercial payer coverage? A: CEO Michael McGarrity stated that while projections are based on unit growth expectations, the market access managed care team and RCM team are viewed as productivity engines. He noted stability in ASPs and confidence in discipline, with potential opportunities from data initiatives like PROMT, PROTECT, and AI positioning, though nothing specific to guide to at this time. Q: Beyond the sequential improvement in revenue, are there other internal KPIs, such as Salesforce productivity or account touch points, that suggest things are moving in the right direction? A: CEO Michael McGarrity highlighted metrics around physician adoption of the full pathway solution, compliance to the pathway within large urology practices, and the growing influence of pathology partners. He noted that GPS requires significantly less tissue than competitors, which resonates with pathologists, and that ConfirmDx helps clarify biopsy limitations rather than questioning pathology reads, creating a sticky and sustainable growth model. Q: On PROTECT, is there anything giving you more confidence, and is the timeline still for a readout early next year? A: CEO Michael McGarrity said the clinical scientific affairs team works directly with Oxford with regular updates, providing monthly confidence in progress. He noted the PROMT publication provides a foundational view and validates GPS as the right test for the PROTECT cohort. While hesitant to give exact timelines, he cited the KOL network, NCCN influence, and the reputation of Dr. Hamdy and the Oxford team as sources of confidence for the study's impact. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-08-13Mdxhealth Reports Second Quarter 2026 Financial Results
GlobeNewswire
Mdxhealth Reports Second Quarter 2026 Financial Results
Second quarter revenue growth of 16% to $27.2 millionConference call with Q&A today at 4:30 PM EST / 22:30 CET IRVINE, California – August 13, 2026 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leader in urology-focused precision diagnostics, today announced its financial results for the second quarter ended June 30, 2026. Michael K. McGarrity, CEO of mdxhealth, commented: “We delivered sequential revenue growth of $3.3 million from Q1 to Q2, establishing a clear path toward meeting or exceeding our 2026 revenue guidance of $110-115 million, which represents 20-26% growth over 2025 (excluding Resolve). Importantly, the commercial team’s successful transition of all our Resolve customers by June 30, coupled with the integration of the ExoDx business and our sales force restructuring over the past two quarters, is reflected in the strong recovery of our tissue-based business in Q2. We expect our tissue growth rates to accelerate further throughout the second half of the year, driving a return to positive adjusted EBITDA as we exit 2026. These results underscore our track record of operating discipline and commercial execution. Combined with a strengthened balance sheet, we are well-positioned to drive sustainable revenue growth and profitability. Finally, our recent peer-reviewed publication of the GPS PROMPT results from the Oxford study, alongside our ongoing AI initiatives, provides compelling support for expanding our market conversion and share gains in the active surveillance population ahead of our landmark PROTECT study.” Key Highlights for the second quarter from continuing operations: Revenue of $27.2 million, an increase of 16% over prior year period, and a sequential increase of $3.3 million over Q1 Operating loss of $5.1 million compared to $1.5 million for second quarter of 2025, primarily due to increased operating expenses related to the ExoDx acquisition Net loss of $9.5 million, an increase of 36% over prior year period Adjusted EBITDA of $(2.3) million compared to $1.1 million for the same period last year Tissue-based (Confirm mdx and GPS mdx) test volume of 12,525, a decrease of 1% over prior year period, but a 13% sequential increase over Q1 Liquid-based (Exo mdx) test volume of 13,578 compared to Select mdx volume of 4,455 for the same period last year Period-end cash and cash equivalents balance of $19.…Read full documentShow less
Second quarter revenue growth of 16% to $27.2 millionConference call with Q&A today at 4:30 PM EST / 22:30 CET IRVINE, California – August 13, 2026 (GlobeNewswire) – MDxHealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leader in urology-focused precision diagnostics, today announced its financial results for the second quarter ended June 30, 2026. Michael K. McGarrity, CEO of mdxhealth, commented: “We delivered sequential revenue growth of $3.3 million from Q1 to Q2, establishing a clear path toward meeting or exceeding our 2026 revenue guidance of $110-115 million, which represents 20-26% growth over 2025 (excluding Resolve). Importantly, the commercial team’s successful transition of all our Resolve customers by June 30, coupled with the integration of the ExoDx business and our sales force restructuring over the past two quarters, is reflected in the strong recovery of our tissue-based business in Q2. We expect our tissue growth rates to accelerate further throughout the second half of the year, driving a return to positive adjusted EBITDA as we exit 2026. These results underscore our track record of operating discipline and commercial execution. Combined with a strengthened balance sheet, we are well-positioned to drive sustainable revenue growth and profitability. Finally, our recent peer-reviewed publication of the GPS PROMPT results from the Oxford study, alongside our ongoing AI initiatives, provides compelling support for expanding our market conversion and share gains in the active surveillance population ahead of our landmark PROTECT study.” Key Highlights for the second quarter from continuing operations: Revenue of $27.2 million, an increase of 16% over prior year period, and a sequential increase of $3.3 million over Q1 Operating loss of $5.1 million compared to $1.5 million for second quarter of 2025, primarily due to increased operating expenses related to the ExoDx acquisition Net loss of $9.5 million, an increase of 36% over prior year period Adjusted EBITDA of $(2.3) million compared to $1.1 million for the same period last year Tissue-based (Confirm mdx and GPS mdx) test volume of 12,525, a decrease of 1% over prior year period, but a 13% sequential increase over Q1 Liquid-based (Exo mdx) test volume of 13,578 compared to Select mdx volume of 4,455 for the same period last year Period-end cash and cash equivalents balance of $19.2 million Results exclude Resolve mdx, which has been discontinued and accounted for as a “discontinued operation” for the current and prior year periods. Discontinuation of the Resolve mdx Business As previously announced in our first-quarter update, the Company made the strategic decision to discontinue the Resolve UTI offering to renew our focus on our core prostate cancer business. We successfully completed this wind-down in Q2, with the permanent cessation of operations of our wholly-owned subsidiary Delta Laboratories, LLC (“Delta Lab”) and its Plano, Texas laboratory prior to June 30, 2026. Having met the requisite accounting criteria, the Resolve business is now formally classified as a discontinued operation in accordance with IFRS. As required by these reporting standards, all current and prior-year financial metrics discussed in this release and related financial statements reflect only our continuing core operations, with the historical results of the Resolve business fully excluded. In connection with the wind-down of Resolve, on August 3, 2026, Delta Lab executed an Assignment for the Benefit of Creditors (“ABC”), assigning all assets and liabilities of Delta Lab to a receiver who will have broad powers and authority to take possession of, and protect and preserve, the assets of Delta Lab, and provide creditors of Delta Lab the opportunity to file proofs of claims. The ABC was executed in order to expedite an orderly sale and disposition of the assets of Delta Lab and pay claims in order of priority, inclusive of the previously disclosed Novitas Solutions’ $10.4 million recoupment claim received by Delta Lab in relation to certain of its historical Resolve mdx claims. The ABC process is limited solely to Delta Lab, which has been independently operated since it was acquired in 2022. Registered Direct PlacementOn August 11, 2026, the Company executed a registered direct placement of 44,052,862 ordinary shares of the Company without nominal value (“Ordinary Shares”) at the Nasdaq closing price-per-share of $0.454 on August 10, 2026, for total gross proceeds of $20 million before deducting estimated offering expenses. The shares were sold to institutional investors, including some of the Company’s largest shareholders, and were placed directly by the Company under its shelf registration statement on Form S-3 filed on February 17, 2026. Financial review of continuing operations for the three and six months ended, June 30, 2026 and 2025 * Comparative information has been re-presented to reflect the classification of the Resolve business as a discontinued operation** A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Non-IFRS Measures" Results from continuing operations for the three months ended June 30, 2026 Revenue increased 16% to $27.2 million compared to $23.4 million for the prior year. Revenue in the second quarter of 2026 and 2025 was comprised of 73% and 96% from tissue-based tests, respectively. Gross profit increased 11% to $17.9 million compared to $16.1 million for the prior year. Gross margins were 65.7% as compared to 68.6% for the prior year, a reduction of 2.9 percentage points, primarily attributed to test mix. Operating loss increased 236% to $5.1 million compared to $1.5 million for the prior year, driven by increased operating expenses related to the ExoDx acquisition in September 2025. Net loss increased 36% to $9.5 million compared to $7.0 million for the prior year, primarily driven by higher operating expenses related to the ExoDx acquisition in September 2025. Adjusted EBITDA was ($2.3) million compared to $1.1 million for the same period last year. A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Non-IFRS Disclosure." Results from continuing operations for the six months ended June 30, 2026 Revenue increased 14% to $51.1 million compared to $45.0 million for the prior year. Revenue in the first six months of 2026 and 2025 was comprised of 75% and 96% from tissue-based tests, respectively. Gross profit increased 7% to $32.6 million compared to $30.5 million for the prior year. Gross margins were 63.7% as compared to 67.9% for the prior year, a reduction of 4.2 percentage points, primarily attributed to test mix. Operating loss increased 113% to $13.3 million compared to $6.2 million for the prior year, driven by increased operating expenses related to the ExoDx acquisition in September 2025. Net loss increased 18% to $19.2 million compared to $16.3 million for the prior year, primarily driven by higher operating expenses related to the ExoDx acquisition in September 2025. Adjusted EBITDA was ($7.6) million compared to ($0.5) million for the same period last year. A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Non-IFRS Disclosure." Cash and cash equivalents as of June 30, 2026, were $19.2 million. Pro-forma cash balance as of June 30, 2026, including the $20 million in gross proceeds from the registered direct placement discussed above, equals $39.2 million. Conference Call Michael K. McGarrity, Chief Executive Officer, and Ron Kalfus, Interim Chief Financial Officer, will host a conference call and Q&A session today at 4:30 PM EST / 22:30 CET. The call will be conducted in English and a replay will be available for 30 days. To participate in the conference call, please select your phone number below: United States: 1-833-309-3473 Belgium: 0800 72 519 United Kingdom: 0808 101 1183 Conference ID: MDX2Q26 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1768432&tp_key=e5dee9dbef To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduledstart time. About mdxhealthMdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests, based on proprietary genomic, epigenomic, exosomal and other molecular technologies, assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth. Non-IFRS disclosure In addition to the Company’s financial results determined in accordance with IFRS, the Company provides adjusted EBITDA and adjusted EBITDA margin, non-IFRS measures that the Company determines to be useful in evaluating its operating performance. The Company defines adjusted EBITDA as net loss from continuing operations less interest expense, depreciation and amortization of intangible assets, impairment, share-based compensation, fair-value adjustments, provision for inventory obsolescence, reduction in force severance costs, ExoDx acquisition expenses, amendments related to the Exact Sciences earnout, income tax benefit (expense), and other financial and non-cash expenses. Management believes that presentation of non-IFRS financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Adjusted EBITDA margin is calculated as adjusted EBITDA divided by total revenue. The Company uses this non-IFRS financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. However, non-IFRS financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with IFRS. For example, non-IFRS adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. The Company’s presentation of expected non-IFRS adjusted EBITDA is a forward-looking statement about the Company’s future financial performance. This non-IFRS measure includes adjustments like share-based compensation, debt extinguishment costs, fair-value adjustments related to contingent considerations that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Additionally, management does not forecast many of the excluded items for internal use. Information reconciling forward-looking non-IFRS measures to IFRS measures is therefore not available without unreasonable effort and is not provided. The occurrence, timing, and amount of any of the items excluded from IFRS to calculate non-IFRS could significantly impact the Company’s IFRS results. Forward-Looking Statement: This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding expected future operating results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated timing and benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities and expectations for future events or performance. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; changes in payer claims reimbursement practices and MDxHealth estimates regarding collection amounts for tests; the results of recoupment decisions and related appeals; the impacts and effectiveness of exiting from discontinued operations; our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; our ability to remain in compliance with financial covenants made to and make scheduled payments to our creditors; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the ExoDx and GPS prostate cancer businesses will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS mdx, Exosome Diagnostics, ExosomeDx, Exo mdx, ExoDx, ExoDx Prostate Intelliscore (EPI), and Monitor mdx are trademarks or registered trademarks of MDxHealth SA and its affiliates. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark and all other trademarks and service marks, are the property of their respective owners. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF PROFIT OR LOSS * Comparative information has been re-presented to reflect the classification of the Resolve business as a discontinued operation. CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF FINANCIAL POSITION CONDENSED UNAUDITED CONSOLIDATED STATEMENT OF CASH FLOWS UNAUDITED RECONCILIATION OF IFRS TO NON-IFRS FINANCIAL MEASURES * Comparative information has been re-presented to reflect the classification of the Resolve business as a discontinued operation. 1) Primarily related to GPS and ExoDx contingent considerations, option to pay Bio-Techne and Exact Sciences earnout in shares, and Exact Sciences 5-year warrants2) Bank fees and other non-cash expenses For more information: [email protected] LifeSci Advisors (IR & PR)John FrauncesManaging DirectorTel: +1 917 355 [email protected] Attachment MDXH 1H26 Earnings Release - FINAL
TranscriptFY2026 Q22026-08-13FY2026 Q2 earnings call transcript
Earnings source - 78 paragraphs
FY2026 Q2 earnings call transcript
Please note this call is being recorded and we are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to John Fraunces with LifeSci Advisors. Please go ahead.
Before we begin, I would like to remind everyone that the company will make forward-looking statements during today's call. Whether in prepared remarks or during the Q&A session, these forward-looking statements are subject to inherent risks and uncertainties. These risks and uncertainties are detailed in the Risk Factors section of the company's filings with the Securities and Exchange Commission, specifically in the company's annual report on Form 20-F. I will now turn the call over to Michael McGarrity, Chief Executive Officer.
Thanks, John, and thank you all for joining us for our second quarter 2026 earnings conference call. With me today is Ron Kalfus, Interim Chief Financial Officer. Q2 was a pivotal quarter for MDxHealth. Following the unanticipated reimbursement developments related to our Resolve test in April, our Q2 results reflect the strength of our core business, which was precisely what we committed to deliver with our sales force focused solely on this significant market opportunity.
More specifically, we communicated that we expected sequential revenue acceleration from Q1 to Q2. We generated a 14% sequential revenue increase, or $3.3 million, representing the largest quarter-over-quarter revenue acceleration in our company's history. We also anticipated a recovery in our tissue-based business following the expected impact in Q4 and Q1 post-integration and sales force restructuring from the ExoDx acquisition. We delivered that recovery with a sequential increase of greater than 1,400 tissue-based tests.
We aggressively set a goal to transition all of our Resolve customers by the end of Q2, an objective that we achieved while also building deep credibility with our customer base through the unwavering dedication and support of our sales and client services teams. Based on our revenue growth expectations, coupled with exceptional operating discipline, we are now firmly on track to return to positive adjusted EBITDA as we exit 2026. Following the discontinuation of Resolve UTI testing, we completed the cessation of our Plano, Texas, lab operations and eliminated the $10.4 million contingent liability to Novitas from our corporate structure as a discontinued operation through an organized wind down of that independently operated entity.
Finally, we strengthened our balance sheet and cash position through a registered direct financing that generated $20 million in proceeds priced at the market with no discount or warrant structure. I want to express my sincere gratitude to our entire organization for their professionalism and perseverance over these challenging 90 days. In my experience, you are defined not by what happens to you, but by how you respond.
Our entire team, from sales and client services through revenue cycle management and laboratory operations, demonstrated incredible character, professionalism, and commitment to our customers and to each other. I am immensely proud to stand alongside such a resilient group of professionals who stepped up when it mattered most. I would also like to specifically thank our Plano, Texas, team for their unwavering commitment to serving our customers through their final day of operations on June 30th.
Their professionalism and dedication to our patients was extraordinary, and our entire organization owes them a debt of gratitude for their integrity and service. This company did not suddenly forget how to operate and execute. While our operational strength was clearly on display in Q2, we are confident that our growth trajectory will return to the performance we have consistently delivered over the last number of years as we move through the remainder of 2026 and beyond.
This confidence is rooted in our high-growth market opportunity, our strong competitive position, and our unparalleled suite of clinically actionable diagnostics, supporting clinicians and patients across the entire prostate cancer continuum. Our foundational commitment to focus, execution, and growth has never been more evident than during our navigation of Q2, and we look forward to continuing that momentum. Before turning the call over to Ron, I want to thank our shareholders who stepped up to support our mission, as well as our customers and stakeholders for their continued trust and confidence in MDxHealth.
We are incredibly proud of our team's commitment not only to our operational and financial performance, but to what matters most, the patient and family on the other side of every single sample we receive. I will follow up with some closing comments and view forward, but first, let me turn the call over to Ron to walk through our second quarter financial results. Ron?
Thank you, Mike. Before I dive into the financial results, I want to briefly frame our Q2 presentation. As detailed in our press release, we have successfully completed the wind-down of our Resolve UTI business in Q2 with the permanent cessation of operations of our Delta Laboratories subsidiary and its Plano, Texas laboratory prior to June 30, 2026. Having met the requisite accounting criteria, the Resolve business is now formally classified as a discontinued operation.
As such, all current and prior year financial metrics reflect only our continuing core operations with the historical results of the Resolve business fully excluded. Our revenue for the second quarter ended June 30, 2026 was $27.2 million, an increase of 16% over the second quarter of 2025. Revenue in the second quarter of 2026 was comprised of 73% from tissue-based tests, compared to 96% for the same period last year.
Moving below the revenue line, our gross profit for the quarter was $17.9 million, an increase of 11% as compared to $16.1 million for the second quarter of 2025. Gross margins were 65.7% compared to 68.6% for Q2 2025, a decrease of 2.9 percentage points, primarily attributed to tissue versus liquid mix. Our operating loss for the quarter increased to $5.1 million, compared to $1.5 million for the second quarter of 2025, primarily driven by increases in headcount and other OpEx related to the ExoDx acquisition, which were not present at this time last year. Our net loss increased 36% to $9.5 million, compared to $7 million for the prior year, primarily driven by OpEx related to the ExoDx acquisition.
We are confident that our guidance and associated revenue growth will absorb this increase in acquired OpEx and return to our trend of adjusted EBITDA profitability as we exit this year. Adjusted EBITDA for the second quarter was a negative $2.3 million, compared to a positive $1.1 million for the second quarter of 2025. Note that a reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release.
Finally, cash and cash equivalents as of June 30, 2026, total $19.2 million. In addition, on August 11, we executed a $20 million registered direct placement with existing shareholders. After taking this transaction into account, our pro forma cash balance as of June 30, 2026, would have been $39.2 million. This concludes my overview of the financial results, and I will now turn the call back to Mike.
Thanks, Ron. When speaking with stakeholders following our Q1 results, I noted that while the decision to discontinue Resolve was unfortunate, I believed it would likely end up being a blessing in disguise, one that would manifest as an absolute singular focus on the vertical we have built in the urology market and our prostate cancer franchise in particular. Our Q2 performance represents the first clear evidence of that promise and potential being realized.
From a focus perspective, the peer-reviewed publication of data from our Oxford ProMPT study is already being recognized and embraced by our urology customers. Furthermore, we see clear visibility into the potential of our landmark Oxford ProtecT study to transform the market landscape, particularly for patients in the active surveillance setting. Our vision is to establish GPS as the only diagnostic test with NCCN level 1 evidence in this critical patient population, which represents the majority of patients in the prostate cancer diagnostic pathway.
Additionally, we continue to advance our AI initiatives, which will deliver meaningful incremental value to both new and existing customers across our urology and pathology stakeholders. Over the past two years, our efforts to establish and expand our reach with pathology partners alongside the urologists they serve have paid significant dividends. We are confident that both Confirm and GPS will continue to resonate strongly with this key constituency through their unique clinical features, benefits, and supporting data.
All of this progress in Q2 reinforces our commitment to and confidence in meeting or exceeding our full year guidance of $110 million-$115 million in revenue while returning to adjusted EBITDA profitability as we exit this year. Our culture of quality first and customers always continues to drive our growing reputation for excellence across the urology market.
We remain steadfast in our commitment to delivering growth and value, cementing MDxHealth's position as the leading precision diagnostics company focused exclusively on our high-growth urology market opportunity. As always, we carry a profound responsibility to create long-term value for all of our stakeholders, including patients, clinicians, payers, and shareholders. Thank you for your continued interest in and support of MDxHealth. I will now turn the call back over to the operator to open the line for questions.
Thank you. If you'd like to ask a question, press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star one to ask a question. We'll take our first question from Thomas Flaten with Lake Street. Your line is open.
Hey, Mike and Ron. Congrats on a nice rebound quarter. Two questions from me. Given the sequential increase on the tissue side, do you think we can conclude that the challenges were internal rather than there being any competitive dynamics that were impacting volumes previously?
Yeah, Thomas. I think we were ahead of that a little bit. I kind of signaled we expected Q4 and Q1 to be a little choppy, really a function of the restructuring of the sales organization. We had a territory reorganization and then cross-training of the new reps, remapping of the customer base, the combined businesses, and that's really what we saw. We didn't see it in, hopefully Q2 is the beginning of evidence of that it would disrupt our position in the market. Just more create a little diversion of the focus for that quarter or two and we're confident that Q2 signals that we're back to the full sales force focused on our core menu.
Excellent. Then as we go from first half to second half towards your guidance range, do you expect the revenue progression to be pretty linear, or should we expect some type of fluctuation between Q3 and Q4?
Yeah, Thomas, I would say generally linear. Q3 is always a little bit of a wild card with some seasonality just based on patients and clinician flow through our urology customer base. So that being the only potential factor to affect Q3, we would expect acceleration in Q3 and Q4 in linear-ish.
Great. I appreciate that. Thank you.
Thanks, Thomas.
We'll take our next question from Dan Brennan with TD Cowen. Your line is open.
Hey, guys. Thanks for the questions. Maybe just the first one, it's nice to hear that liability, I think that was there from the Texas Medical case, is off the books now, I guess, because you closed the lab. Just wanted to confirm, I guess. Did you guys discuss that at 1Q, like this ability to remove that given these actions? Because it sounds like it's a nice removal on your part.
Yeah, Dan, thanks. I didn't want to get ahead of that. There was obviously a lot of work to occur with all of our outside counsels and advisors on setting that up and consent from our lending partner, but it came together as we anticipated. We believed the structure, the way we set that entity up allowed for that. We just wanted to make sure that we had it all tight, and we were able to close that up here for this communication. So we believe that is a significant de-risking element to our business as we go forward.
Good stuff. Then the raise, obviously getting it done at the market, it was attractive. Just wondering, can you speak to a little bit how that sets you up? Obviously, your adjusted EBITDA positive exiting the year, which is nice to hear. You have this $20 million of additional capital. As we look ahead, I know you've got the debt, and you have some payments from Exact still out the next couple of years. Just how do we think about the need for further capital versus internally generated cash flow?
Yeah, I think your last statement is key, right? We anticipate that based on the scale of our business and the leverage we have in the P&L, one of the key execution items we've focused on is significant and consistent top-line growth while holding our OpEx really straight away for the past three years. We expect both those to continue, and that leverage generates meaningful progress in the business beginning to fund itself from an operating basis. We're confident that that gives us pretty strong leverage as we go forward.
This capital, our balance sheet position, obviously provides significant runway for the business. And we've demonstrated, I think, with our partner, Exact, Abbott, flexibility on that. All those options remain in front of us, but the two key points, and also the equity option on that, they are stakeholders in the company as well. We're really counting on the business progress growth continuing that really begins to fund some of those obligations. But we have clear runway through that period right now.
Terrific. Okay, guys. Thanks a lot.
Thank you, Dan.
We'll take our next question from Bill Bonello with Craig-Hallum. Your line is open.
Hey, guys. Thanks a lot. I want to circle back on a couple of the topics that have been talked about. I guess first again on tissue. It was great to see the sequential increase, but it looks like volume's still down on a year-over-year basis, yet competitors still growing in the mid-teens. You did have one competitor talk about weakness in the low-risk segment of the market.
However, I guess I'm just trying to get a sense of if things are sort of back to functioning on the sales force front without distraction, not destruction, why wouldn't we think of that being a business that should be growing faster year-over-year? I know you talked about acceleration, but maybe give us some sense of what you think the potential is for that business in a more normalized year-over-year growth.
Yeah, Bill, I absolutely get the question. I think, at the risk of pointing to a comp, Q2 of last year was our highest tissue-based quarter. I don't want to lean too much on that. I think one other note of Q2, when I commented with Thomas on tissue in Q4 and Q1, Q2, one of the things that I was, I don't want to say concerned about, but required a lot of focus was our sales organization also in a six week period in the back half of the quarter, had to focus on transitioning all of our Resolve customers.
While we didn't disclose the number, that was hundreds of customers and thousands of urologists that were using that test. So that lift was significant, probably equal to or more than the restructuring of the sales organization based on the time. They completed that with all of our customers being successfully transitioned to their acceptance while driving that sequential acceleration. I get it, the flat year-over-year, we're not celebrating that on a go-forward basis, but our guidance as it's set up requires a return to year-over-year growth that we were seeing prior to this.
Our current guide at $110 million-$115 million contemplates 20%-26% growth, which would suggest that if you look at our 2026 for tissue by quarters, we'd be down 12 flat, and then up accelerated. I guess hopefully that's a fair answer that we expect as we post and discuss Q3 and post and discuss Q4. We would agree, we do think our position in that lower risk category, the active surveillance population we reference, is really gaining strength, and we'll continue to count on that.
That's what our sales force will be focused on. I give a lot of credit to the team for doing two things at once, right? Driving the recovery in the business and taking care of all those customers. It's important to note, virtually all of those Resolve customers are prostate cancer customers. So it required real focus and goodwill working with our customers to obviously not upset our base, and we think we successfully achieved that.
That's helpful. Just to be crystal clear, because as we thought through the implications for you in low risk, we sort of could have envisioned one of two scenarios. One, you're seeing similar maybe macro level decline in utilization, or two, you're taking share. It sounds like from your answer, you're not necessarily seeing any kind of headwind in terms of utilization. Is that fair, or I'm putting words in your mouth?
No, I think that's fair. When we refer to our growth on the tissue side, particularly with GPS, I often reference two drivers of growth. One is market conversion. In other words, still, Bill, as you know, a significant part of that market opportunity is there for urologists that do not currently use biomarker testing in the active surveillance population and share. I think our growth trajectory over the past couple of years has been driven by both, and we expect that to continue.
So it's kind of comparing to the two competitors in that space and how they report, it's a combination of are we taking share from them or are we converting the market? I think the ProMPT data today and the ProtecT data ultimately really help with both. But particularly on that conversion side, hopefully that holds together for you. But that's an important point that we see as the opportunity.
That's super helpful. Just one last one. Is it possible to give us any sense of what the liquid volume growth looked like on a pro forma basis so that we have some sense of what the underlying, because obviously big boost from the acquisition, but so we have some sense of what the underlying growth is?
I'm not sure I. Go ahead.
Bill, I don't think we can because pro forma would be comparing Exo to Select, but we stopped selling Select mdx, so we can't really compare one to the other. It's not like we're selling bulk entirely.
I was trying to think of Exo last year versus Exo this year.
Oh, I see.
To get that picture.
Yeah. I get it now. Yeah, we're not doing that. It wasn't our as-reported numbers, but we're confident that we'll be continuing to drive growth into the Exo product line. Really, again, with the integration, we're a couple quarters in. The majority of the Exo business that began to be covered by us was covered by legacy MDxHealth reps. We're confident that this is really the quarter where we begin to see that, and Q4 will be the first where we have actual year-over-year comps for a quarter on an Exo volume.
Okay. Thank you very much.
Thank you, Bill.
We'll take our next question from Mark Massaro with BTIG U.S. Bank. Your line is open.
Hey, guys. Thank you for taking the questions. Since we are in the month of August, and we're tidying up our models, I was wondering if you could react to your confidence in perhaps growing 20% in 2027. And if you could just walk us through some of the puts and takes as to how you're thinking about the next full year.
Sure, Mark. Probably premature to provide visibility to guidance for 2027, but I get the question. We think that there is significant opportunity for growth with the Exo business as we go forward. Then on the tissue side, I will provide more detail around our AI initiative there as well, which obviously would drive largely GPS. But we are very confident that that can and will begin to contribute in 2027. Then the third arm of that would be the ProMPT data in the active surveillance population.
When you look at the data from that peer-reviewed publication, we expect it to mirror what will come out in the landmark ProtecT. I think our urologists today are noting that. That coupled with the AI initiatives we have going that we would expect to be supportive as we come out of this year and the next. We think we will have a basis to provide good growth trajectory 2027 and beyond.
That is super helpful. Congrats on the raise, I guess. As Dan Brennan mentioned, you do have some puts and takes with the balance sheet. But I wanted to get a sense for, in recent years, you have brought in some assets and now you have divested some assets. How are you thinking about the portfolio going forward? I know you are talking about some internal development. With the $20 million of cash coming in, how are you thinking about exploring potential tuck-ins? I know in the past you have been able to bolt on things at really rational and reasonable valuations. I am just curious how you are thinking about the potential for inorganic growth from here.
Yeah, I guess I would answer that two ways. One, per your previous question and hopefully my answer, we are very positive and confident on our current market opportunity. We believe it can support our growth for the foreseeable future based on our initiatives, our discipline on the operating side, and our sales force execution. That said, we are a growth company. I think I have shared with you and everybody that we run a growth strategy process here.
We are always looking out. I would say that that is flipped significantly where I think, and please take this the right way, it is not meant to be self-serving, but anybody who is looking for partner or opportunity or channel or infrastructure into the urology vertical, we are an obvious first stop. I want to be careful here. I think you and I want to discuss don't get too far ahead with potential opportunities for growth, but we'll be very disciplined as we have in the past.
For right now, in the near term for sure, we are focused on execution of the opportunity we have in front of us in clearing what I said this Resolve development was probably a two to three quarter setback from our previous trajectory. We've got one quarter posted. We look forward to posting Q3 and Q4, and then I think 2027 and beyond comes more clear, and then we can revisit how we think about growth. Definitely opportunities there. We just want to be disciplined.
That makes perfect sense. If I can squeeze one more in. I wanted to ask, some of the other lab testing companies have seen benefits from revenue cycle management initiatives, collecting claims from prior periods, and other companies have been winning some additional commercial payer coverage and the like. I know there's a lot of focus on volume growth, but I just wanted to get a sense for is there any juice to squeeze on the ASP side?
Well, as I think you know, but just to be clear, our projections, the way we build our model is based on our expectation of unit growth, but we view our market access managed care team and our RCM team as productivity engines for the business as well. While I'm not guiding to pick up there, I think we've seen stability in our ASPs, and I guess based on some of the dynamics in the reimbursement landscape across the industry, unrelated to Resolve, but just in general, we're confident that we've got good discipline there.
Yeah, we consistently The data helps, Mark, as you know. I think when you look at some of the initiatives that we have, even our AI initiatives, there's some opportunity there from both the ProMPT ProtecT as well as the way we'll end up positioning our AI to support that aspect of our business, but nothing to project to right now.
That sounds good. Thanks for the time.
Thank you, Mark.
Once again, for your questions, that is star one. We'll move next to Matt Larew with William Blair. Your line is open.
Hi, good afternoon. Mike, you've referenced both last quarter and this quarter the notion sort of a blessing in disguise, and you've also last quarter made quite a bit of progress on the Exo integration. Certainly, the sequential improvement in revenue maybe is the obvious KPI that would be a mark of that. But just curious in terms of other internal KPIs, whether it's sales force productivity, account touchpoint utilization, anything else that you're seeing underneath the hood that suggests to you those things are moving in the right direction and perhaps that's what's giving you additional confidence on the ramp of the back half of the year?
Yeah. Matt, I think there's nothing we don't metric and measure here with regard to the way our business builds our opportunity. I don't want to disclose all those, but we look at everything from the way our physicians adopt our menu with the goal of selling our full pathway solution to the way they adopt within a large group practice. In other words, you get a few of them to buy into our pathway in a reliable way where it's internally we call it compliance to our pathway.
The other component to it is what I noted in my prepared comments, which is the influence and impact of pathology, which really has made a difference. I'll just be brief here, but there's a couple features of GPS in particular that really resonate with pathology, right? It requires significantly less tissue than the two competing tests. Once pathology understands the value of Confirm that it's not proving a pathology read was wrong, it's the limitations of biopsy.
All those things work with what we track to say, "Yeah, we're getting pick-up here. It's sustainable, it's sticky," and it helps actually create the model for our sales organization, our medical science liaison team. We have pathology supporting our resources that all work together to give us the data that suggests really helps us build our model and definitely our forecast as we go through this year.
Okay. Thanks. Then just on ProtecT, just sort of the way you described it today, the notion of clear visibility into that, just wondering if there's anything that you're seeing that's giving you more confidence. I think that is reading out early next year, but I guess maybe just confirm that that's still the timeline, and what you anticipate the response might be from the physician community once you get that out there.
Yeah. I think I've hesitated to give timelines there, but what I would say is our clinical scientific affairs team works directly with Oxford. We have consistent regular updates with them. They're almost a project management team coupled with our CSA and project management teams working in collaboration. So it gives us confidence every month that we're making progress there. It's difficult to handicap the timing of the readout, and then the secondary benefit would be the guideline work that we'll do on the other side of that.
So based on our KOL network that that group has established, our somewhat influencer reach into the NCCN, and the reputation and sway of Dr. Hamby and the Oxford team, that gives us our confidence. Each quarter, I'll provide Matt better visibility as to how we think that comes timing-wise. I think the last comment I will make on that is that getting the ProMPT published in a peer-reviewed manner does provide really good foundational view of this is what we expected. This is what they somewhat mandated that we do the ProMPT first before they turn on the ProtecT cohort, which is the most valuable one in the world. In hindsight, that was the right thing to do because it gave us confidence, them confidence, that GPS was and is the right test to prove that out.
Okay. Thank you.
Thank you, Matt.
It does appear that there are no further questions at this time. Thank you. This brings us to the end of today's meeting. We appreciate your time and participation, and you may now disconnect.
Investor releaseQuarter not tagged2026-07-30Mdxhealth to Release Second Quarter 2026 Financial Results on August 13
GlobeNewswire
Mdxhealth to Release Second Quarter 2026 Financial Results on August 13
Company to Host Conference Call with Live Q&A, August 13, 2026, at 4:30pm ET / 22:30 CET IRVINE, California – July 30, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH), a leading precision diagnostics company, today announced it will release its financial results for the second quarter ended June 30, 2026, after market close on Thursday, August 13, 2026. The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company’s website. About Mdxhealth Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests, based on proprietary genomic, epigenomic, exosomal and other molecular technologies, assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth. For more information: [email protected] LifeSci Advisors (IR & PR)John Fraunces, Managing DirectorTel: +1 917 355 [email protected]
Investor releaseQuarter not tagged2026-05-14MDxHealth S.A. Q1 2026 Earnings Call Summary
Moby
MDxHealth S.A. Q1 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management decided to discontinue the Resolve UTI offering and close its Plano, Texas laboratory due to an increasingly uncertain and unsustainable reimbursement landscape. The exit was triggered by an unexplained policy reversal from Novitas, the Texas Medicare administrator, which created unacceptable levels of payer uncertainty. The strategic shift allows the company to focus 100% of its capital and sales force on the core prostate cancer menu, including Confirm, GPS, and ExoDx. Operational efficiencies are expected to accelerate following the completed transition of SelectMDx customers to the Exo platform in Q1. The company is initiating an AI-dedicated strategic platform to leverage its biopsy tissue database for improved operating efficiency and clinical value. Management attributes Q1 tissue volume performance to a multifactorial impact, including sales force integration and the transition of Resolve customers. Updated 2026 revenue guidance for the core cancer business is set at $110 million to $115 million, representing 20% to 26% year-over-year growth. Management expects sequential acceleration in tissue-based test volumes throughout the remainder of 2026 as the sales force refocuses. The company anticipates the Plano laboratory operations will fully cease by the end of June 2026. Future growth will be supported by AI-enhanced endpoints in clinical trials, such as the PROTECT trial, to improve the prognostic value of the GPS test. The financial outlook assumes that removing 'reimbursement noise' from the UTI business will reset the company's trajectory toward sustainable profitability. Novitas is seeking up to $10.4 million in recoupments for historical Resolve testing claims, which the company is vigorously defending through the Medicare appeals process. Management believes any potential liability from the Novitas claim, if it occurs, would likely be amortized over a 5-year period. A $15 million earn-out payment for 2025 was made to Exact Sciences on April 15, 2026, reducing pro forma cash to $28.2 million. The company is shifting to a conservative 'cash only' non-accrual accounting method for certain revenues going forward to mitigate reimbursement volatility. One stock. Nvidia-level potential. 30…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management decided to discontinue the Resolve UTI offering and close its Plano, Texas laboratory due to an increasingly uncertain and unsustainable reimbursement landscape. The exit was triggered by an unexplained policy reversal from Novitas, the Texas Medicare administrator, which created unacceptable levels of payer uncertainty. The strategic shift allows the company to focus 100% of its capital and sales force on the core prostate cancer menu, including Confirm, GPS, and ExoDx. Operational efficiencies are expected to accelerate following the completed transition of SelectMDx customers to the Exo platform in Q1. The company is initiating an AI-dedicated strategic platform to leverage its biopsy tissue database for improved operating efficiency and clinical value. Management attributes Q1 tissue volume performance to a multifactorial impact, including sales force integration and the transition of Resolve customers. Updated 2026 revenue guidance for the core cancer business is set at $110 million to $115 million, representing 20% to 26% year-over-year growth. Management expects sequential acceleration in tissue-based test volumes throughout the remainder of 2026 as the sales force refocuses. The company anticipates the Plano laboratory operations will fully cease by the end of June 2026. Future growth will be supported by AI-enhanced endpoints in clinical trials, such as the PROTECT trial, to improve the prognostic value of the GPS test. The financial outlook assumes that removing 'reimbursement noise' from the UTI business will reset the company's trajectory toward sustainable profitability. Novitas is seeking up to $10.4 million in recoupments for historical Resolve testing claims, which the company is vigorously defending through the Medicare appeals process. Management believes any potential liability from the Novitas claim, if it occurs, would likely be amortized over a 5-year period. A $15 million earn-out payment for 2025 was made to Exact Sciences on April 15, 2026, reducing pro forma cash to $28.2 million. The company is shifting to a conservative 'cash only' non-accrual accounting method for certain revenues going forward to mitigate reimbursement volatility. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expects the adjudication process to last for a significant period unless resolved immediately in their favor. They expressed absolute certainty in the medical necessity and clinical validity of the Resolve test, noting it was marketed specifically to complex urology patients rather than general UTI cases. Acceleration is expected to be driven by the removal of sales force distractions and the launch of new AI-enhanced digital innovation partnerships. Management noted that while Q1 was 'choppy' due to integration, their guidance requires tissue growth to return to expected levels in the second half of the year. The company expects the majority of closure costs, including severance and lease charges, to be materially offset by operational efficiencies across RCM and shared services. Most expenses previously associated with Resolve were incentive compensation for the sales organization, which will now be redirected.
Investor releaseQuarter not tagged2026-05-14Mdxhealth Reports Q1-2026 Results
GlobeNewswire
Mdxhealth Reports Q1-2026 Results
Mdxhealth Reports Q1-2026 Results Conference call with Q&A today at 4:30 PM ET / 22:30 CET IRVINE, California – May 13, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leading precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2026. Michael K. McGarrity, CEO of mdxhealth, commented: “As we prioritized the integration of our recently acquired ExoDx business and to allow for renewed focus on our core prostate cancer business, we have made the strategic decision to discontinue our Resolve UTI offering and laboratory operations in Plano, Texas. The Resolve test was uniquely designed for our urology customer base to aid in the rapid diagnosis and therapy of patients presenting with often serial, complex, multi-organism infections. Despite the urgent clinical need and medical necessity of the Resolve test, the increasingly uncertain reimbursement landscape, fueled by an unexplained recent policy reversal by our Texas lab’s Medicare administrator (Novitas), has made the continued operation of this business line unsustainable. We believe this proactive exit allows us to focus our operating discipline and sales force on our prostate cancer precision diagnostics, which will drive the most value for our customers, patients and stakeholders. We are confident that the near-term impact of this decision will augment our ability to drive sustainable growth of our prostate cancer menu, despite its associated impact on our Q1 results and 2026 guidance. We believe our renewed focus will advance market share and our ability to explore opportunities in additional urologic cancers that align with our sales force focus and customer base. An additional benefit of this refocus has been to catalyze our commitment to leverage the promise of Artificial Intelligence (AI) into every aspect of our business. Earlier this year, we initiated an AI-dedicated strategic initiative to build-out an AI data platform throughout the company. With the hundreds of thousands of unique biopsy tissue specimens received in our laboratory, our goal is to leverage AI to improve our operating efficiency and clinical value, as well as optimize our customer experience. With our recently announced landmark PROTECT trial, the study protocol with Oxford University includes AI-enhanced endpoints, targeted to improve the pe…Read full documentShow less
Mdxhealth Reports Q1-2026 Results Conference call with Q&A today at 4:30 PM ET / 22:30 CET IRVINE, California – May 13, 2026 (GlobeNewswire) – Mdxhealth SA (NASDAQ: MDXH) (the "Company" or "mdxhealth"), a leading precision diagnostics company, today announced its financial results for the first quarter ended March 31, 2026. Michael K. McGarrity, CEO of mdxhealth, commented: “As we prioritized the integration of our recently acquired ExoDx business and to allow for renewed focus on our core prostate cancer business, we have made the strategic decision to discontinue our Resolve UTI offering and laboratory operations in Plano, Texas. The Resolve test was uniquely designed for our urology customer base to aid in the rapid diagnosis and therapy of patients presenting with often serial, complex, multi-organism infections. Despite the urgent clinical need and medical necessity of the Resolve test, the increasingly uncertain reimbursement landscape, fueled by an unexplained recent policy reversal by our Texas lab’s Medicare administrator (Novitas), has made the continued operation of this business line unsustainable. We believe this proactive exit allows us to focus our operating discipline and sales force on our prostate cancer precision diagnostics, which will drive the most value for our customers, patients and stakeholders. We are confident that the near-term impact of this decision will augment our ability to drive sustainable growth of our prostate cancer menu, despite its associated impact on our Q1 results and 2026 guidance. We believe our renewed focus will advance market share and our ability to explore opportunities in additional urologic cancers that align with our sales force focus and customer base. An additional benefit of this refocus has been to catalyze our commitment to leverage the promise of Artificial Intelligence (AI) into every aspect of our business. Earlier this year, we initiated an AI-dedicated strategic initiative to build-out an AI data platform throughout the company. With the hundreds of thousands of unique biopsy tissue specimens received in our laboratory, our goal is to leverage AI to improve our operating efficiency and clinical value, as well as optimize our customer experience. With our recently announced landmark PROTECT trial, the study protocol with Oxford University includes AI-enhanced endpoints, targeted to improve the performance and prognostic value of our GPS test. In addition, we have initiated a collaboration with a customer-facing digital innovation company to develop AI-enhanced offerings, building on the evidence-based clinical excellence of our tissue-based tests, thereby expanding our market opportunity in prostate and other urologic cancers. By streamlining our operations and removing the reimbursement volatility associated with Resolve, we are effectively resetting our growth trajectory for the remainder of the year. We are establishing updated 2026 revenue guidance for our core cancer business, now excluding Resolve, of $110-115 million, which would represent 20-26% year-over-year growth over our 2025 core cancer business.” Key highlights for the first quarter of 2026: Revenue of $27.4 million, an increase of 13% over prior year period Pro-forma adjusted core revenue (excluding the Resolve business) of $23.9 million, an increase of 11% over prior year period pro-forma adjusted revenue of $21.6 million. See the “unaudited pro-forma adjusted” tables at the end of this press release for a full reconciliation of our continuing operations Tissue-based (Confirm mdx and GPS mdx) test volume of 11,110, a decrease of 12% over prior year period Liquid-based (Exo mdx and Resolve mdx) test volume of 26,235, an increase of 128% over prior year period Quarter-end cash and cash equivalents balance of $43.2 million Financial review for the quarter ended March 31, 2026 * A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Non-IFRS Disclosure" Revenue increased 13% to $27.4 million compared to $24.3 million for the prior year period. Tissue-based tests accounted for 66% and 85% of total first quarter 2026 and 2025 revenue, respectively. Gross profit increased by 7% to $16.6 million compared to $15.5 million for the prior year period. Gross margins were 60.7% compared to 63.8% for the prior year period, a reduction of 3.1 percentage points, primarily attributed to our test mix. Operating expenses increased 19% to $23.9 million compared to $20.1 million for the prior year period, primarily driven by increases in headcount and other operating expenses related to the ExoDx acquisition. Net loss decreased by 4% to $8.9 million compared to $9.2 million for the year period, primarily as a result of the increased operating expenses related to the ExoDx acquisition, offset by lower net financial expenses. Adjusted EBITDA was ($4.3) million, an increase of 226% compared to ($1.3) million for the same period last year, primarily due to higher operating loss. A reconciliation of IFRS to non-IFRS financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Non-IFRS Disclosure." Cash and cash equivalents as of March 31, 2026, were $43.2 million. Subsequent Events On April 15, 2026, mdxhealth made its 2025 earnout payment to Exact Sciences in the amount of $15.0 million. After taking into account this earnout payment, our pro-forma cash balance as of March 31, 2026, would have been $28.2 million. On April 20, 2026, the Company received a Medicare contractor recoupment decision from Novitas Solutions totaling approximately $10.4 million related to a retrospective review of certain historical Resolve mdx claims. The Company strongly disagrees with the contractor's findings and is vigorously contesting the contractor’s decision on substantive and procedural grounds. Management has evaluated the matter and concluded that the recognition criteria for an accrual have not been met. The existence and ultimate amount of any obligation are contingent on the outcomes of a multi-level appeals process, which are uncertain future events not wholly within the Company's control. At this time no reliable estimate of any obligation can be made. Accordingly, the matter is accounted for as a contingent liability, and no provision has been recorded for the first quarter ended March 31, 2026. On May 8, 2026, the Company approved a strategic plan to exit the Resolve mdx business, including the cessation of operations at its laboratory facility in Plano, Texas. As a result of this decision, the Company expects to incur restructuring and other exit-related charges in connection with the wind-down. These charges are expected to consist principally of (i) employee severance and other termination benefits, (ii) charges associated with the Plano facility lease, including accelerated amortization of the right-of-use asset and leasehold improvements, (iii) impairment of long-lived assets associated with the Resolve mdx business, including capitalized assets and equipment, (iv) charges relating to the disposition or termination of vendor and supplier contracts, and (v) other exit-related costs. The amount and timing of these charges has not been finalized and will be determined and recognized in accordance with applicable IFRS in future periods as the wind-down is executed and additional information becomes available. Conference Call Michael K. McGarrity, Chief Executive Officer and Ron Kalfus, Interim Chief Financial Officer, will host a conference call and Q&A session today at 4:30 PM EST / 22:30 CET. The call will be conducted in English and a replay will be available for 30 days. To participate in the conference call, please select your phone number below: United States: 1-800-245-3047 Int’l: 1-203-518-9765 Belgium: 0800 72 519 United Kingdom: 0808 101 1183 Conference ID: MDX1Q26 Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1758088&tp_key=21da6e9d38 To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduled start time. About mdxhealth Mdxhealth is a leading precision diagnostics company that provides actionable molecular information to personalize patient diagnosis and treatment. The Company’s tests, based on proprietary genomic, epigenomic, exosomal and other molecular technologies, assist physicians with the diagnosis and prognosis of prostate cancer and other urologic diseases. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth. Non-IFRS disclosure In addition to the Company’s financial results determined in accordance with IFRS, the Company provides adjusted EBITDA and adjusted EBITDA margin, non-IFRS measures that the Company determines to be useful in evaluating its operating performance. The Company defines adjusted EBITDA as net loss less interest expense, depreciation and amortization of intangible assets, impairment, share-based compensation, fair-value adjustments, debt extinguishment costs, provision for inventory obsolescence, reduction in force severance costs, ExoDx acquisition expenses, amendments related to the Exact Sciences earnout, income tax benefit (expense), and other financial and non-cash expenses. The Company also presents adjusted revenue, adjusted cost of goods, adjusted gross profit, adjusted operating expenses, adjusted operating loss, adjusted net loss, and adjusted basic and diluted loss per share, which exclude the impact of the recently discontinued Resolve business. Management believes that presentation of non-IFRS financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Adjusted EBITDA margin is calculated as adjusted EBITDA divided by total revenue. The Company uses this non-IFRS financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. However, non-IFRS financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with IFRS. For example, non-IFRS adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. The Company’s presentation of expected non-IFRS adjusted EBITDA is a forward-looking statement about the Company’s future financial performance. This non-IFRS measure includes adjustments like share-based compensation, debt extinguishment costs, fair-value adjustments related to contingent considerations that are difficult to predict for future periods because the nature of the adjustments pertain to events that have not yet occurred. Additionally, management does not forecast many of the excluded items for internal use. Information reconciling forward-looking non-IFRS measures to IFRS measures is therefore not available without unreasonable effort and is not provided. The occurrence, timing, and amount of any of the items excluded from IFRS to calculate non-IFRS could significantly impact the Company’s IFRS results. Forward-Looking Statement: This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “potential,” “expect,” “will,” “goal,” “next,” “potential,” “aim,” “explore,” “forward,” “future,” and “believes” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements regarding expected future operating results; our strategies, positioning, resources, capabilities and expectations for future events or performance; and the anticipated timing and benefits of our acquisitions, including estimated synergies and other financial impacts. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, product development efforts, our strategies, positioning, resources, capabilities, the anticipated results of recoupment decisions and related appeals and expectations for future events or performance. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products; the acceptance of our products and services by healthcare providers; our ability to achieve and maintain adequate levels of coverage or reimbursement for our current and future solutions we commercialize or may seek to commercialize; the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; changes in payer claims reimbursement practices and MDxHealth estimates regarding collection amounts for tests; the results of recoupment decisions and related appeals ;our ability to obtain and maintain regulatory approvals and comply with applicable regulations; timing, progress and results of our research and development programs; the period over which we estimate our existing cash will be sufficient to fund our future operating expenses and capital expenditure requirements; our ability to remain in compliance with financial covenants made to and make scheduled payments to our creditors; the possibility that the anticipated benefits from our business acquisitions like our acquisition of the ExoDx and GPS prostate cancer businesses will not be realized in full or at all or may take longer to realize than expected; and the amount and nature of competition for our products and services. Other important risks and uncertainties are described in the Risk Factors sections of our most recent Annual Report on Form 20-F and in our other reports filed with the Securities and Exchange Commission. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The mdxhealth logo, mdxhealth, Confirm mdx, Select mdx, Resolve mdx, Genomic Prostate Score, GPS mdx, Exosome Diagnostics, ExosomeDx, Exo mdx, ExoDx, ExoDx Prostate Intelliscore (EPI), and Monitor mdx are trademarks or registered trademarks of MDxHealth SA and its affiliates. The GPS test was formerly known as and is frequently referenced in guidelines, coverage policies, reimbursement decisions, manuscripts and other literature as Oncotype DX Prostate, Oncotype DX GPS, Oncotype DX Genomic Prostate Score, and Oncotype Dx Prostate Cancer Assay, among others. The Oncotype DX trademark and all other trademarks and service marks, are the property of their respective owners. UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION UNAUDITED CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS UNAUDITED RECONCILIATION OF IFRS TO NON-IFRS FINANCIAL MEASURES Unaudited pro-forma adjusted P&L for the quarter ended March 31, 2026 (a) Represents the removal of revenue generated by the Resolve mdx business in Q1-2026 (b) Represents the removal of Resolve mdx cost of goods sold (COGS) related to Q1-2026 (c) Represents the removal of operating expenses in Q1-2026 that are directly attributable to the Resolve mdx business and will be entirely eliminated upon its closure; this excludes any allocated corporate overhead Unaudited pro-forma adjusted P&L for the quarter ended March 31, 2025 (a) Represents the removal of revenue generated by the Resolve mdx business in Q1-2025 (b) Represents the removal of Resolve mdx cost of goods sold (COGS) related to Q1-2025 (c) Represents the removal of operating expenses in Q1-2025 that are directly attributable to the Resolve mdx business and will be entirely eliminated upon its closure; this excludes any allocated corporate overhead Unaudited pro-forma adjusted P&L Q1-2026 vs Q1-2025 UNAUDITED RECONCILIATION OF IFRS TO NON-IFRS FINANCIAL MEASURES 1) Primarily related to GPS and ExoDx contingent considerations, GPS earnout amendment, Exact Sciences 5-year warrants, and option to pay Exact Sciences and Bio-Techne earnout in shares 2) Bank fees and other non-cash expenses For more information: [email protected] LifeSci Advisors (IR & PR) John Fraunces, Managing Director Tel: +1 917 355 2395 [email protected] Attachment MDXH 26
Investor releaseQuarter not tagged2026-05-14MDxHealth (MDXH) Q1 2026 Earnings Transcript
Motley Fool
MDxHealth (MDXH) Q1 2026 Earnings Transcript
Image source: The Motley Fool. Wednesday, May 13, 2026, at 4:30 p.m. ET Chief Executive Officer — Michael K. McGarrity Interim Chief Financial Officer — Ron Kalfus Michael K. McGarrity: Thanks, John. And thank you all for joining us for our first quarter 26 earnings conference call. With me today is Ron Kalfus, Interim Chief Financial Officer. Since I joined MDX Health, we have been very consistent in our message and our mission. We are driven by 3 core operating principles, focus, execution, and growth. And while our commitment to those principles remains absolute, we also carry a great responsibility to our patients, our customers, and our stakeholders to make strategic decisions that are rooted in transparency, and operating discipline. Our Q1 results, our recent developments, and the disclosures we issued today reflect a number of decisions driven by that exact responsibility. Over the past few years, our aggressive growth strategy and commercial execution have positioned MDxHealth as the leader in precision diagnostics focused specifically in urology. This strategy transformed our company from $11 million in revenue in 2019 to $108 million in 2025. We took gross margins from the 20s to the mid-60s and we reached adjusted EBITDA profitability last year prior to our acquisition of the EksoDx business. However, as we prioritize the ongoing integration of ExoDx, and the growth of our core prostate cancer business we have made the strategic decision to discontinue our Resolve UTI offering and to cease operations at our laboratory facility in Plano, Texas. This was a carefully considered decision. The resolve test was uniquely designed for our urology customer base, to aid in the rapid diagnosis and treatment of patients presenting with serial complex, multiorganism infections. Despite the urgent clinical need, and the undeniable medical necessity of this test, to the urologist to order it, the increasingly uncertain reimbursement landscape, has made the continued operation of this business line unsustainable. Specifically, an unexplained recent policy reversal by our Texas Labs Medicare administrator, Novitas, has created a level of payer uncertainty that we are simply no longer willing to accept. In connection with this, we recently received a communication from Novitas seeking $10.4 million in recoupments of historical resolved testing claims. We believe t…Read full documentShow less
Image source: The Motley Fool. Wednesday, May 13, 2026, at 4:30 p.m. ET Chief Executive Officer — Michael K. McGarrity Interim Chief Financial Officer — Ron Kalfus Michael K. McGarrity: Thanks, John. And thank you all for joining us for our first quarter 26 earnings conference call. With me today is Ron Kalfus, Interim Chief Financial Officer. Since I joined MDX Health, we have been very consistent in our message and our mission. We are driven by 3 core operating principles, focus, execution, and growth. And while our commitment to those principles remains absolute, we also carry a great responsibility to our patients, our customers, and our stakeholders to make strategic decisions that are rooted in transparency, and operating discipline. Our Q1 results, our recent developments, and the disclosures we issued today reflect a number of decisions driven by that exact responsibility. Over the past few years, our aggressive growth strategy and commercial execution have positioned MDxHealth as the leader in precision diagnostics focused specifically in urology. This strategy transformed our company from $11 million in revenue in 2019 to $108 million in 2025. We took gross margins from the 20s to the mid-60s and we reached adjusted EBITDA profitability last year prior to our acquisition of the EksoDx business. However, as we prioritize the ongoing integration of ExoDx, and the growth of our core prostate cancer business we have made the strategic decision to discontinue our Resolve UTI offering and to cease operations at our laboratory facility in Plano, Texas. This was a carefully considered decision. The resolve test was uniquely designed for our urology customer base, to aid in the rapid diagnosis and treatment of patients presenting with serial complex, multiorganism infections. Despite the urgent clinical need, and the undeniable medical necessity of this test, to the urologist to order it, the increasingly uncertain reimbursement landscape, has made the continued operation of this business line unsustainable. Specifically, an unexplained recent policy reversal by our Texas Labs Medicare administrator, Novitas, has created a level of payer uncertainty that we are simply no longer willing to accept. In connection with this, we recently received a communication from Novitas seeking $10.4 million in recoupments of historical resolved testing claims. We believe this action by Novitas is without merit and we are vigorously defending our position through the formal Medicare appeals process. We remain fully confident in our appellate strategy and in the clinical validity of our testing services. While stepping away from resolve is unfortunate, for the thousands of patients who have benefited from the test, We view this proactive exit as a powerful catalyst for our company. First and foremost, it allows us to focus our capital and operational excellence entirely on our prostate cancer precision diagnostics. Where we drive the most scalable value by stepping away from the reimbursement volatility of Resolve our entire sales organization is now able to focus 100% on our core prostate cancer menu, confirm, GPS, ExoDx. It is important to highlight that we have already completed the ExoDx driven strategic mapping and cross training of our expanded sales force in Q1. Furthermore, we successfully met our internal goal of transitioning our SelectMDx customers to Exo, resulting in accelerating operating efficiencies as we no longer process select samples. With our sales force fully armed and aligned, we are cementing our position as the growth vertical in urology. Offering an unmatched suite of precision diagnostics addressing every single point in the prostate cancer pathway. An additional value driver of this refocus is our ability to catalyze our commitment to leveraging artificial intelligence. Earlier this year, we initiated an AI dedicated strategic initiative to build out an AI data platform across the company. With the hundreds of thousands of unique biopsy tissue specimens we receive, our goal is to leverage AI to advance operating efficiency, maximize clinical value, and optimize our customer experience. In fact, we are seeing evidence of this with our landmark protect trial in collaboration with the University of Oxford, where the study protocol now includes AI enhanced endpoints targeted to improve the prognostic value of our GPS test. Furthermore, we have initiated a collaboration with a customer facing digital innovation company to develop AI enhanced offerings. That build on the evidence based excellence of our tissue tests. We are incredibly proud of our team's commitment to not only the financials, but to what really matters. The patient and family on the other side of every sample we receive. I will follow-up with some closing comments. And our updated view forward But first, let me turn the call over to Ron to walk through our first quarter financial results. Ron? Ron Kalfus: Thank you, Mike. Before I dive into the financial results, I want to briefly frame our Q1 presentation. Because our board's strategic decision to exit the ResolveMDx business occurred in April, the financial results of the Plano laboratory and Resolve business remain embedded within our as reported continuing operations for the first quarter. However, to provide investors with a clear and transparent view of our core business trajectory moving forward, we have provided pro forma as-adjusted tables in our earnings release. These tables entirely back out the revenue and direct operating expenses of the Resolve business. To help you model the ongoing business, I will provide our statutory results today and compare them directly to these pro forma metrics for our continuing prostate cancer operations. Our as reported revenue for the first quarter ended 03/31/2026, was $27.4 million. However, on a pro forma basis, excluding the Resolve business entirely, revenues for our core prostate cancer operations increased by 11% to $23.9 million demonstrating the continued commercial execution of our integrated sales team. Moving below the revenue line, our statutory as reported gross profit was $16.6 million. When we back out the Resolve business, our pro forma gross profit for the quarter was $15 million yielding a pro forma gross margin of 62.9% compared to 68.0% for Q1 25. With a difference primarily related to tissue versus liquid mix. Our as reported operating expenses for the quarter were $23.9 million, resulting in an as reported operating loss of $7.3 million. On a pro forma basis, excluding the direct operating expenses of Resolve, our pro forma operating expenses were $22.9 million resulting in a pro forma operating loss of $7.9 million compared to a pro forma operating loss of $4.7 million for the prior year. Primarily related to the addition of the ExoDx business. Our statutory as reported net loss was $8.9 million. Excluding Resolve, our pro forma net loss was $9.4 million compared to a pro forma net loss of $9.3 million for Q1 of last year. Once again, I would like to direct investors to the tables at the back of today's press release where we have provided a detailed columnar reconciliation of our statutory IFRS results to the pro forma adjustments. Finally, our balance sheet remains solid for the quarter with cash and cash equivalents as of 03/31/2026 was $43.2 million. In addition, on April 15, we made the 2025 earn out payment to Exact Sciences in the amount of $15 million After taking into account this earn out payment, our pro forma cash as of 03/31/2026, would have been $28.2 million This concludes my overview of the financial results and I will now turn the call back to Mike. Michael K. McGarrity: Thanks, Ron. As we look forward, we believe that the near term impact of our strategic exit from Resolve will ultimately augment our ability to drive sustainable, highly profitable growth across our core prostate cancer menu. By streamlining our operations and removing the reimbursed noise associated with the UTI business, we are effectively resetting our growth trajectory. Today, we are establishing updated 2026 revenue guidance for our core cancer business excluding Resolve, of $110 million to $115 million This represents a robust 20% to 26% year-over-year growth rate for our core cancer business. Our culture of quality first and customer always ensures our growing reputation for excellence in the urology market. We will continue to strive to deliver on our commitments of growth and value, positioning MDX Health as the leading precision diagnostics company focused solely on the high growth urology space. As always, we carry a great deal of responsibility to provide value to all of our stakeholders. Including our patients, our clinicians, our payers, and our shareholders. Thank you for your continued interest in and support of MDX Health. Now I will turn the call back to the operator for questions. Operator: Thank you, Mr. McGarrity. Ladies and gentlemen, at this time, if you do have any questions, please press 1. And as a reminder, you can remove yourself from the queue by pressing 2. Once again, that is 1 for questions. We will go first this afternoon to Dan Brennan with TD Cowen. Dan Brennan: Great, guys. Thanks. Thanks for the questions. Maybe just starting on the Novitas. Issue, I guess you guys cited $10.4 million related to retrospective review of certain historical ResolveMDx claims. And I know you are going to, vigorously defend it. But can you any other color you can provide on what the issue is there? And, you know, given the cash balance, how do we think about the 10.4 million and just to cushion you guys think you have on that? And, you know, anything on timing, how this will play out? Michael K. McGarrity: Yeah, Dan. We anticipate this will not be resolved or adjudicated for a significant period of time unless it is immediately in our favor. And we feel like that is a high likelihood. You know, this is a very recent development. That we are communicating. So we you know, we have no sense of our multiple initial replies. So it is difficult to bracket the timeline. But likely, well beyond the period of time that we are focused on here between now and the end of the year. And I would say that although we do not anticipate any liability, or recoupment, If there were any minimal, it would be amortized over a 5-year period. But you know, I only share that based on our understanding We do not anticipate we would anticipate a quick positive resolution or a longer term adjudication in our favor. Dan Brennan: Got it. And Mike, is there any just maybe 1 more quick 1 there. Is there any issues or any feedback you have had throughout the process of billing there where they were only in the question, you know, clinical utility of the test, or are there any issues on that front or just any-- yeah. Anything else you can share on that front? Michael K. McGarrity: You can imagine, we do not have any further comment on our any communication back and forth other than to present full transparency and everything we know as of today. We I will say, we have absolute certainty and would find impossible to argue the medical necessity and clinical validity of our test for the patients that are treated. it is important to note that a lot of this focus on fraud and abuse with infectious disease testing, which UTI has been noted in what is not policy based but communications coming out of Novitas. It is not the type of test that we are offering to the customer base we are, right? We market our tests specifically to urology customers. For a very specific patient population. And it is patients that are referred to urology. Right? You have a UTI, do not call a urologist. This is not your run of the mill immediate care. Get put on Cipro, and you are brand new. These are patients that present in men with enlarged prostate or BPH prone to these. Women are referred to urology for these. We have had patients in clinicians present at our national sales meeting And the clinical value is impossible to argue, and remarkably compelling. So the broad panel of organisms and susceptibility markers in addition, a little bit more detail, our test is you know, in the 20s of organisms and susceptibility markers. Each run is a specific reaction for each analyte or target organism. So we have exhausted when we entered the market or following the AMAG guidelines I will leave it there. But it leads to our confidence and, for sure, the medical necessity and our ultimate process. Dan Brennan: Got it. No, thanks for that, Mike. And maybe for the follow-up, just on the just on the core, maybe versus your guys' expectations, obviously, really strong growth in liquid. Tissue is up against a really tough comp there. Just give me, how did the quarter play out versus your expectations? And as you kind of, have the updated guide, like, what are you incorporating or, like, how are you thinking about the rest of the year across your 2 businesses? Thank you. Yep. Michael K. McGarrity: Yep. Thanks, Dan. Yeah. I think we would appreciate your comments because it is it is what we expected I communicated as far as q 4 and Q1 with the integration There will be some focus on the transition of our Resolve customers. it is important to note also that every 1 of our Resolve customers urology customers. So our reps will be navigating that with our customers. We are confident that we will navigate through that. And then our guidance adjustment really reflects while we do not break it out and have not broken it out historically, made the assumption that it is really stripping out our expectation of what resolve would contribute that is essentially the calculus of our new guide. And any color just on you know, the strength in liquid? Obviously, to show up against a really tough comp, you know, on a comp adjusted nice growth. Just yeah. Any anything to point out across the 2 segments, you know, as you look out, yeah, as we look out for the rest of the No. I think there might be some embedded strength there because we are there were some additional adjustment to our Q1 revenue based on the fact that we are conservatively not accruing going forward here. Cash only. I do not have any additional comment other than our guidance clearly reflects confidence in our core cancer business. Both tissue and exo. And we you know what? I will just add that you know, at the risk of being clever here, you know, we view this as we believe we will look back on this as blessing in disguise from a focus benefit of our sales organization because 1 rep selling 4 tests resolve is a great test that has been broadly adopted, but it requires focus and time with our customers. And, obviously, our organizational support of that. Dan Brennan: Okay. Great. Operator: Thanks. Thank you, Dan. Thank you. We go next now to Bill Bonello. With Craig Hallum. Bill Bonello: Hey, guys. Thanks for taking the question. I want to focus a little bit on the cash situation here. So when you think about the you know, restructuring expenses that you are gonna incur, do you have any sense of the magnitude of the cash outlay that may go along with that? Michael K. McGarrity: Yeah, Bill. I think we are confident that our expectation would be the operation would cease by June. Obviously, the majority of the Plano operation is carried in COGS. But we expect to derive any additional expense associated with that will be absorbed by additional efficiencies across our operation that has adjacent or I guess, you know, blended support of our resolved business. In our operation across RCM client services and shared services with operation and product support. So I guess that, hopefully, that answers your question if I understood your question. Bill Bonello: I mean, somewhat. I mean, it just you know, you have got you have got I just wanna make sure I understand that. I mean, there is gonna be some severance payments you are gonna be making. there is charges on the lease that you mentioned. Etcetera. Those are all cash. And so you are thinking you can offset that cash outlay that you know, may come over the next couple of quarters. You can completely offset that with enhancements to the rest of the business. Michael K. McGarrity: We are confident that there will be a considerable offset there, Bill. Okay. And then when I think about The only term I use differently was that-- completely-- I mean, whether it is complete materially offset. Yep. For transparency purposes. Yep. Bill Bonello: Okay. And then, just when I look at the at the at the pro formas, and I think, you know, there is maybe $700 thousand-and-something of expense that you know, put with Resolve, can you give us some sense of what those expenses are just and what I am trying to get at here is you know, how easy will it actually be to eliminate operating expense? what is truly attached to resolve and what was, you know, just you know, covering fixed costs. Michael K. McGarrity: Mainly incentive comp. Bill. Through our sales organization. For the resolve test, if I am under hearing that question correctly. And again, as we know, we are not in a position right now to fully reconcile, but to your 2 part question, we expect the majority of the offset of closing of the operation, the associated cost with that, to be offset by efficiencies across the organization. And from an OpEx perspective, while I noted that the majority of OpEx that OpEx will not change materially because majority of the Plano carry was in COGS. We would expect some benefit. IC is a good example. Right? To our sales programs. Bill Bonello: Okay. that is that is really helpful. And then just I guess, if I can, I will get out of the way and let other people ask questions. But just on the tissue volume, just trying to get a better understanding of what is going on there. it is been, you know, sort of moving steadily downward. And I know, you know, you have been doing a big integration and Salesforce was distracted by that. But it is sort of hard to believe that these trends that there is nothing else at all happening. So I guess I am I am just trying to get you know, what can you tell us about whether you are actually been losing some customers on the GPS side or, you know, maybe people are you know, not continuing to use confirm or, what-- why are we seeing volume actually? Going down? Michael K. McGarrity: Yeah. So I think I understand the question. I think I would say there is a multifact-- multifactorial impact there. Right? We have made significant progress, as I have noted, and based on our trending consistent growth profile, is sticky adoption. There are aspects of our tissue based test that are require focus and continued work with our customer base. With both Confirm and GPS. You commented on the integration, which I fully anticipated. And we expect clearly reflected in our guidance to see sequential acceleration on the tissue side even with the focus required on this new development related to resolve, on the tissue side in Q3, I am sorry, Q2, Q3, and Q4 as we go forward. And that is part of the calculus that we understand with our mapping of our customer base, our utilization rates, our you know, the implied churn or whatever that we would have. And we have made so much progress on that over the net last couple years. That we are confident that sticks. And as we look at the comp quarter that Dan noted, we would attribute it to those multiple factors. And our guidance requires that comes back online on the tissue side as we anticipated at the beginning of the year. Knowing that Q1 would be choppy. Bill Bonello: Sure. Okay. Thank you. Operator: Thank you, Bill. Thank you. And just a quick reminder, everyone. Star 1 for questions today. We will go next now to Mark Massaro with BTIG. Mark Massaro: Hey, guys. Thank you for taking the question. I apologize, I hopped on the call a few minutes late. So I wanted to just ask a clarifying question. You know, I saw from your press release that you received a Medicare recoupment decision from Novitas. But I wanted to ask, did you receive a noncoverage determination? So I am just the clarification is the coverage suspended at this time? Michael K. McGarrity: Mark. My answer to that is we have not I do not know that Novitas has a coverage policy. Which your very experienced in this segment. I mean, I do not think I commented you know, MolDx or California MAC has a clear policy related to UTI testing. Novitas does not. There have been communications that have come out over time, probably over the last year or 2, where there calling attention to it and focused on fraud and abuse. I think this is government down to, and I think that MolDX has probably held up as well. Difficult to navigate through MolDX We have experienced that. That they have a standard in a policy coverage. We have followed the AMA guidelines and the guidelines associated with how we have built Novitas in Medicare for the past 5 years, Mark. And we know, I think, you know, you would probably know this too from landscape perspective. We are not alone here. In fact, I would add an additional point here. That we have urology customers that have brought UTI testing in house. Through whatever methodology they are using or platform And they are coming to us saying that they are experiencing reimbursement challenges and are looking to bring reimbursement challenges, inconsistencies, But we do not have a policy to lean on. To explain their behavior. And we are very confident to my opening comment, which you missed, We can follow-up that medical necessity is unquestioned. And a very ambiguous, seemingly, change in their posture on paying because they pay for over time. Mark Massaro: Okay. Thank you for clarifying that, Mike. Michael K. McGarrity: We are not willing to try different billing schemes We are just making what we believe is the prudent near and long term decision for our company and for all of our stakeholders to maintain our transparency and integrity. it is unfortunate it is remarkably unfortunate because of the value of patients and the way we have marketed this test. Okay. Mark Massaro: So I understand why you made the decision to cease operations in Texas. But, you know, did you guys evaluate the option to run the test out of a separate lab you know, in a Medicare jurisdiction that does have coverage? Michael K. McGarrity: Yeah. Mark, I do not think I would comment anymore on all of the complex decision making process that we went through. So I do not really have a comment. Our Irvine Laboratories are in Molodiacs, which has a noncoverage decision for UTI test. Yep. Mark Massaro: Alright. And then last 1 for me. Are you seeing any you know, as a follow-up to Bill's question, on the tissue volume side, Are you seeing any changes in the competitive landscape that you can speak of? Michael K. McGarrity: Nothing material. From the 2 competitors. On the GPS side. Mark Massaro: Okay. Thank you for the time. Operator: Thank you, Mark. Thank you. We will take a follow-up question now from Dan Brennan at TD Cowen. Dan Brennan: Hey, guys. Maybe just 1 more since we would probably follow-up later. Just Michael, to your point on the tissue volume acceleration, can you just elaborate a little bit in terms of some of the initiatives and efforts that you kind of discussed in terms of seeing that sequential acceleration? Any color-- qualitative color you can provide? About the visibility, confidence in that acceleration? Thanks. Michael K. McGarrity: Yeah. I mean, I think maybe to provide to Mark's last question, you know, the 1 competitive landscape change I should have noted, Mark, is on the AI side. And I think there is a lot of discussion. I do not want to say noise, but awareness of and communication about the promise of AI in our space, particularly relevant to GPS. And what I noted in our strategy here going forward, including the partnership that we have entered into, is that we have been very patient and rigorous in our processes to the best path forward. We have not been asleep at the wheel, but we have also not panicked. I think we have gone through a prudent exercise of our operational value and use of AI. Which does drive, as I noted, all of our clinical data generation and study protocols. But more importantly, the partnership that we have entered into, what I know facing my comment would be there is that they this partner provides relevant urologic pathology services to our common customer base. So we are very, very confident that our patient approach there is not a company in the space that has been partnered with or available with AI technology that we have not spoken to or evaluated, and we are very confident that the efforts we are taking internally and the partnerships that we have embarked on will drive significant support for our GPS and Confirm business. But that coupled with our execution focus of the sales organization I guess those are the couple of different bases that we have for being confident that tissue begins to accelerate as we go forward. Dan Brennan: Got it. Okay. Thank you. Thank you, Dan. Operator: Thank you. Gentlemen, it appears we have no further questions today. So ladies and gentlemen, that will bring us to the conclusion of today's MDxHealth first quarter 26 earnings conference call. We would like to thank you all so much for joining us today, and wish you all a great rest of your day. Goodbye. Before you buy stock in MDxHealth, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and MDxHealth wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $472,744!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,353,500!* Now, it’s worth noting Stock Advisor’s total average return is 991% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. MDxHealth (MDXH) Q1 2026 Earnings Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-14MDxHealth SA (MDXH) Q1 2026 Earnings Call Highlights: Revenue Surge and Strategic Focus Amid ...
GuruFocus.com
MDxHealth SA (MDXH) Q1 2026 Earnings Call Highlights: Revenue Surge and Strategic Focus Amid ...
This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MDxHealth SA (NASDAQ:MDXH) achieved significant revenue growth from $11 million in 2019 to $108 million in 2025. The company improved its gross margins from the 20s to the mid-60s, reaching adjusted EBITDA profitability prior to acquiring the EXODX business. MDxHealth SA (NASDAQ:MDXH) is focusing on its core prostate cancer precision diagnostics, which is expected to drive scalable value. The company has initiated an AI-dedicated strategic initiative to enhance operating efficiency and maximize clinical value. MDxHealth SA (NASDAQ:MDXH) reported a solid balance sheet with cash and cash equivalents totaling $43.2 million as of March 31, 2026. MDxHealth SA (NASDAQ:MDXH) decided to discontinue its Resolve UTI offering due to an uncertain reimbursement landscape. The company received a communication from Novitas seeking up to $10.4 million in recoupments of historical resolved testing claims. MDxHealth SA (NASDAQ:MDXH) reported a pro forma operating loss of $7.9 million for the quarter, compared to a pro forma operating loss of $4.7 million for the prior year. The statutory as-reported net loss was $8.9 million, with a pro forma net loss of $9.4 million. The company anticipates potential restructuring expenses related to ceasing operations at its laboratory facility in Plano, Texas. Warning! GuruFocus has detected 5 Warning Signs with MDXH. Is MDXH fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more details on the $10.4 million recoupment issue with Novitas and its potential impact on your cash balance? A: Michael McGarrity, CEO: We anticipate this issue will not be resolved quickly, possibly extending beyond the end of the year. We believe the action by Novitas is without merit and are defending our position. If any liability arises, it would be amortized over five years, but we expect a favorable resolution. Q: Are there any concerns about the clinical utility or validity of your tests in light of the Novitas issue? A: Michael McGarrity, CEO: We are confident in the medical necessity and clinical validity of our tests. The focus on fraud and abuse in infectious disease testing does not apply to our specific urology-focused tests. Our tests are marketed to a sp…Read full documentShow less
This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MDxHealth SA (NASDAQ:MDXH) achieved significant revenue growth from $11 million in 2019 to $108 million in 2025. The company improved its gross margins from the 20s to the mid-60s, reaching adjusted EBITDA profitability prior to acquiring the EXODX business. MDxHealth SA (NASDAQ:MDXH) is focusing on its core prostate cancer precision diagnostics, which is expected to drive scalable value. The company has initiated an AI-dedicated strategic initiative to enhance operating efficiency and maximize clinical value. MDxHealth SA (NASDAQ:MDXH) reported a solid balance sheet with cash and cash equivalents totaling $43.2 million as of March 31, 2026. MDxHealth SA (NASDAQ:MDXH) decided to discontinue its Resolve UTI offering due to an uncertain reimbursement landscape. The company received a communication from Novitas seeking up to $10.4 million in recoupments of historical resolved testing claims. MDxHealth SA (NASDAQ:MDXH) reported a pro forma operating loss of $7.9 million for the quarter, compared to a pro forma operating loss of $4.7 million for the prior year. The statutory as-reported net loss was $8.9 million, with a pro forma net loss of $9.4 million. The company anticipates potential restructuring expenses related to ceasing operations at its laboratory facility in Plano, Texas. Warning! GuruFocus has detected 5 Warning Signs with MDXH. Is MDXH fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more details on the $10.4 million recoupment issue with Novitas and its potential impact on your cash balance? A: Michael McGarrity, CEO: We anticipate this issue will not be resolved quickly, possibly extending beyond the end of the year. We believe the action by Novitas is without merit and are defending our position. If any liability arises, it would be amortized over five years, but we expect a favorable resolution. Q: Are there any concerns about the clinical utility or validity of your tests in light of the Novitas issue? A: Michael McGarrity, CEO: We are confident in the medical necessity and clinical validity of our tests. The focus on fraud and abuse in infectious disease testing does not apply to our specific urology-focused tests. Our tests are marketed to a specific patient population, and we have followed AMA guidelines. Q: How did the first quarter results compare to your expectations, and what are your projections for the rest of the year? A: Michael McGarrity, CEO: The results were in line with our expectations. We have adjusted our guidance to reflect the exclusion of the Resolve business, projecting $110 million to $115 million in revenue for our core cancer business, representing a 20% to 26% growth rate. Q: Can you elaborate on the restructuring expenses and their impact on your cash situation? A: Michael McGarrity, CEO: We expect the operation to cease by the end of June, with most expenses absorbed by efficiencies across our operations. While there will be some severance and lease charges, we anticipate these will be materially offset by operational enhancements. Q: Are there any changes in the competitive landscape affecting your tissue volume? A: Michael McGarrity, CEO: There are no significant changes from competitors on the GPS side. We are confident in our strategy and expect tissue volume to accelerate as we focus on our core cancer business and leverage AI initiatives. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-05-14MDxHealth Reports Q1 2026 Results: Full Earnings Call Transcript
Benzinga
MDxHealth Reports Q1 2026 Results: Full Earnings Call Transcript
On Wednesday, MDxHealth (NASDAQ:MDXH) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1758088&tp_key=21da6e9d38 MDxHealth reported Q1 2026 revenue of $27.4 million, with core prostate cancer operations revenue at $23.9 million, marking an 11% year-over-year increase. The company announced a strategic shift, discontinuing its Resolve UTI offering and ceasing operations at its Plano, Texas laboratory due to reimbursement uncertainties. Management remains confident in the clinical validity of their services and is appealing a $10.4 million recoupment request from Novitas. MDxHealth is focusing on prostate cancer diagnostics and leveraging AI to enhance operational efficiencies and customer offerings. The company provided 2026 revenue guidance for the core cancer business, excluding Resolve, at $110 to $115 million, representing a 20-26% growth rate. John Fraunces (Moderator) Before we begin, I would like to remind everyone that the Company will make forward looking statements during today's call, whether in prepared remarks or during the Q and A session. These forward looking statements are subject to inherent risks and uncertainties and these risks and uncertainties are detailed in the Risk Factors section of the Company's filings with the Securities and Exchange Commission, specifically in the Company's annual report on Form 20-F. I'll now turn the call over to Michael McGarrity, Chief Executive Officer. Michael McGarrity (Chief Executive Officer) Thanks John and thank you all for joining us for our first quarter 2026 earnings conference call. With me today is Ron Kelfus, Interim Chief Financial Officer. Since I joined MDX Health, we have been very consistent in our message and our mission. We are driven by three core operating principles, focus, execution and growth. And while our commitment to those principles remains absolute, we also carry a great responsibility to our patients, our customers and our stakeholders to make strategic decisions that are rooted in transparency and operating discipline. Our Q1 results, our recent developments and the disclosures w…Read full documentShow less
On Wednesday, MDxHealth (NASDAQ:MDXH) discussed first-quarter financial results during its earnings call. The full transcript is provided below. This transcript is brought to you by Benzinga APIs. For real-time access to our entire catalog, please visit https://www.benzinga.com/apis/ for a consultation. The full earnings call is available at https://viavid.webcasts.com/starthere.jsp?ei=1758088&tp_key=21da6e9d38 MDxHealth reported Q1 2026 revenue of $27.4 million, with core prostate cancer operations revenue at $23.9 million, marking an 11% year-over-year increase. The company announced a strategic shift, discontinuing its Resolve UTI offering and ceasing operations at its Plano, Texas laboratory due to reimbursement uncertainties. Management remains confident in the clinical validity of their services and is appealing a $10.4 million recoupment request from Novitas. MDxHealth is focusing on prostate cancer diagnostics and leveraging AI to enhance operational efficiencies and customer offerings. The company provided 2026 revenue guidance for the core cancer business, excluding Resolve, at $110 to $115 million, representing a 20-26% growth rate. John Fraunces (Moderator) Before we begin, I would like to remind everyone that the Company will make forward looking statements during today's call, whether in prepared remarks or during the Q and A session. These forward looking statements are subject to inherent risks and uncertainties and these risks and uncertainties are detailed in the Risk Factors section of the Company's filings with the Securities and Exchange Commission, specifically in the Company's annual report on Form 20-F. I'll now turn the call over to Michael McGarrity, Chief Executive Officer. Michael McGarrity (Chief Executive Officer) Thanks John and thank you all for joining us for our first quarter 2026 earnings conference call. With me today is Ron Kelfus, Interim Chief Financial Officer. Since I joined MDX Health, we have been very consistent in our message and our mission. We are driven by three core operating principles, focus, execution and growth. And while our commitment to those principles remains absolute, we also carry a great responsibility to our patients, our customers and our stakeholders to make strategic decisions that are rooted in transparency and operating discipline. Our Q1 results, our recent developments and the disclosures we issued today reflect a number of decisions driven by that exact responsibility. Over the past few years. Our aggressive growth strategy and commercial execution have positioned MDX Health as the leader in precision diagnostics focused specifically in urology. This strategy transformed our company from 11 million dollars million in revenue in 2019 to 108 million in 2025. We took gross margins from the 20s to the mid-60s and we reached adjusted EBITDA profitability last year prior to our acquisition of the ExoDx business. However, as we prioritize the ongoing integration of ExoDx and the growth of our core prostate cancer business, we have made the strategic decision to discontinue our Resolve UTI offering and to cease operations at our laboratory facility in Plano, Texas. This was a carefully considered decision. The Resolve test was uniquely designed for our Urology customer base to aid in the rapid diagnosis and treatment of patients presenting with serious, complex, multi-organism infections. Despite the urgent clinical need and the undeniable medical necessity of this test to the urologists who order it, the increasingly uncertain reimbursement landscape has made the continued operation of this business line unsustainable. Specifically, an unexplained recent policy reversal by our Texas Laboratory's Medicare Administrator Novitas has created a level of payer uncertainty that we are simply no longer willing to accept. In connection with this, we recently received a communication from Novitas seeking up to $10.4 million in recoupment of historical Resolve testing claims. We believe this action by Novitas is without merit and we are vigorously defending our position through the formal Medicare appeals process. We remain fully confident in our appellate strategy and in the clinical validity of our testing services. While stepping away from Resolve is unfortunate for the thousands of patients who have benefited from the test, we view this proactive exit as a powerful catalyst for our company. First and foremost, it allows us to focus our capital and operational excellence entirely on our prostate cancer precision diagnostics where we drive the most scalable value. By stepping away from the reimbursement volatility of Resolve, our entire sales organization is now able to focus 100% on our core prostate cancer menu Confirm, GPS, and ExoDx. It is important to highlight that we have already completed the Exo-driven strategic mapping and cross training of our expanded sales force in Q1. Furthermore, we successfully met our internal goal of transitioning our select MDX customers to exo, resulting in accelerating operating efficiencies as we no longer process select samples. With our sales force fully armed and aligned, we are cementing our position as the growth leader in urology, offering an unmatched suite of precision diagnostics addressing every single point in the prostate cancer pathway. An additional value driver of this refocus is our ability to catalyze our commitment to leveraging artificial intelligence. Earlier this year, we initiated an AI dedicated strategic initiative to build out an AI data platform across the company. With the hundreds of thousands of unique biopsy tissue specimens we receive. Our goal is to leverage AI to advance operating efficiency, maximize clinical value and optimize our customer experience. In fact, we are seeing evidence of this with our landmark PROTECT trial in collaboration with the University of Oxford, where the study protocol now includes AI enhanced endpoints targeted to improve the prognostic value of our GPS test. Furthermore, we have initiated a collaboration with a customer facing digital innovation company to develop AI enhanced offerings that build on the evidence-based excellence of our tissue tests. We are incredibly proud of our team's commitment to not only the financials, but to what really matters, the patient and family on the other side of every sample we receive. I will follow up with some closing comments and our updated view forward, but first let me turn the call over to Ron to walk through our first quarter financial results. Ron Ron thank you Mike. Before I dive into the financial results, I want to briefly frame our Q1 presentation. Because our Board's strategic decision to exit the Resolve MDX business occurred in April, the financial results of the Plano Laboratory and Resolve business remain embedded within our reported continuing operations for the first quarter. However, to provide investors with a clear and transparent view of our core business trajectory moving forward, we have provided pro forma as adjusted tables in our earnings release. These tables entirely back out the revenue and direct operating expenses of the Resolve business to help you model the ongoing business. I will provide a statutory result today and compare them directly to these pro forma metrics of our continuing prostate cancer operations. Our as reported revenue for the first quarter ended March 31, 2026 was $27.4 million. However, on a pro forma basis excluding the Resolve business entirely, revenues for our core prostate cancer operations increased by 11% to $23.9 million, demonstrating the continued commercial execution of our integrated sales team. Moving below the revenue line, our statutory as reported gross profit was $16.6 million. When we back out the Resolve business, our pro forma gross profit for the quarter was $15 million, yielding a pro forma gross margin of 62.9% compared to 68% for Q1 2025, with a difference primarily related to tissue versus liquid mix. Our as reported operating expenses for the quarter were $23.9 million, resulting in an as reported operating loss of $7.3 million. On a pro forma basis. Excluding the direct operating expenses of Resolve, our pro forma operating expenses were $22.9 million, resulting in a pro forma operating loss of $7.9 million compared to a pro forma operating loss of 4.7 million dollars for the prior year. Primarily related to the addition of the ExoDx business, our statutory as reported net loss was $8.9 million. Excluding Resolve, our pro forma net loss was $9.4 million compared to a pro forma net loss of $9.3 million for Q1 of last year. Once again, I'd like to direct investors to the tables at the back of today's press release where we have provided a detailed columnar reconciliation of our statutory IFRS results to the pro forma adjustments. Finally, our balance sheet remained solid for the quarter with cash and cash equivalents as of March 31, 2026 totaling $43.2 million. In addition, on April 15th we made the 2025 earn out payment to Exact Sciences in the amount of $15 million. After taking into account this earn out payment, our pro forma cash as of March 31, 2026 would have been $28.2 million. This concludes my overview of the financial results and I will now turn the call back to Mike. Michael McGarrity (Chief Executive Officer) Thanks Ron. As we look forward, we believe that the near term impact of our strategic exit from Resolve will ultimately augment our ability to drive sustainable, highly profitable growth across our core prostate cancer menu. By streamlining our operations and removing the reimbursement noise associated with the UTI business, we are effectively resetting our growth trajectory. Today we are establishing updated 2026 revenue guidance for our core cancer business. Excluding Resolve, of 110 to 115 million dollars. This represents a robust 20 to 26% year over year growth rate for our core cancer business. Our culture of quality first and customer always will ensure our growing reputation for excellence in the urology market. We will continue to strive to deliver on our commitments of growth and value, positioning MDxHealth as the leading precision diagnostics company focused solely on the high growth urology space. As always, we carry a great deal of responsibility to provide value to all of our stakeholders including our patients, our clinicians, our payers and our shareholders. Thank you for your continued interest in and support of MDX Health. Now I'll turn the call back to the operator for questions. OPERATOR Thank you Mr. McGarrity. Ladies and gentlemen, at this time if you do have any questions please press Star one. And as a reminder, you can remove yourself from the queue by pressing Star two.. Once again, that's Star one for Questions will go first this afternoon to Dan Brennan with TD Cowan. Dan Brennan (Equity Analyst at TD Cowan) Great guys, thanks. Thanks for the questions. Maybe just starting on the Novitas issue, I guess you guys cite the 10.4 million related to retrospective review of certain historical Resolve MDX claims and I know you're going to vigorously defend it but can you any other color you can provide on what the issue is there? And given the cash balance, how do we think about the 10.4 million and just the cushion you guys think you have on that and you know, anything on timing, how this will play out? Michael McGarrity (Chief Executive Officer) Yeah, Dan, we anticipate this will not be resolved or adjudicated for a significant period of time unless it's immediately in our favor. And we feel like that that's a high likelihood. We, you know, this is a very recent development that we're communicating so we, you know, we have no sense of our multiple initial replies. So it's difficult to bracket the timeline, but likely well beyond, you know, the period of time that we're focused on here between now and the end of the year. And I would say that although we don't anticipate any liability or recoupment, if there were any minimal, it would be amortized over a five year period. But you know, I only share that based on our understanding. We don't anticipate. We anticipate a quick positive resolution or a longer term adjudication in our favor. Dan Brennan (Equity Analyst at TD Cowan) Got it. And Mike, is there any, just maybe one more quick one there. Is there any issues or any feedback you've had throughout the process of billing there where there were calling into question, you know, clinical utility of the test or is there any issues on that front or just anything else you could share on that? Michael McGarrity (Chief Executive Officer) As you can imagine, we don't have any further comment on our any communication back and forth other than to present full transparency on everything we know as of today. We, I will say we have absolute certainty and would find impossible to argue the medical necessity and clinical validity of our test for the patients that are treated. It's important to note that a lot of this focus on fraud and abuse with infectious disease testing which UTI has been noted in what is not policy based but communications coming out of novitas. It is not the type of test that we are offering to the customer base. We are right. We market our tests specifically to urology customers for a very specific patient population and it is patients that are referred to urology. Right. When you have a uti, you don't call a urologist. This is not your run of the mill immediate care. Get put on Cipro and you're brand new. These are patients that present in men with enlarged prostate or BPH are prone to these women are referred to urology for these. We've had patients and clinicians present at our national sales meeting and the clinical value is impossible to argue and remarkably compelling. So the broad panel of organisms and susceptibility markers. In addition, a little bit more detail. Our test is in the twenties of organisms and susceptibility markers. Each run is a specific reaction for each analyte or target organism. So we have exhausted when we entered the market are following the AMA guidelines. I'll leave it there. But it leads to our confidence and for sure the medical necessity and our ultimate process. Dan Brennan (Equity Analyst at TD Cowan) Got it. No thanks for that Mike. And maybe for the follow up just on the, just on the quarter maybe versus your expectations. Obviously really strong growth in liquid tissue is up against a really tough comp there. Just. Yeah, I mean how did the quarter play out versus your expectations? And as you kind of, you know have the. Have the updated guide like kind of what are you incorporating or like how are you thinking about the rest of the year across your two businesses? Thank you. Michael McGarrity (Chief Executive Officer) Thanks Dan. Yeah, I think we would appreciate your comments because it's what we expected and I communicated as far as Q4 and Q1 with the integration there will be some focus on the transition of our Resolve customers. It's important to note also that every one of our Resolve customers is urology customers. So our reps will be navigating that with our customers. We're confident that we'll navigate through that. And then our guidance adjustment really reflects while we don't break it out and haven't broken it out historically made the assumption that it's really stripping out our expectation of what Resolve would contribute. That's essentially the calculus of our new guide. Dan Brennan (Equity Analyst at TD Cowan) And any color just on you know, the strength in liquid obviously tissue up against a really tough comp. But you know, on a comp adjusted basis, nice growth. Just. Yeah. Anything to point out across the two segments, you know, as you look out, as we look for the rest of the year. Michael McGarrity (Chief Executive Officer) No, I think there might be some embedded strength there because we're There were some additional adjustment to our Q1 revenue based on the fact that we're conservatively not accruing going forward here, cash only. So I don't have any additional comment other than our guidance clearly reflects confidence in our core cancer business, both tissue and exo. And you know, I'll just add that, you know, at the risk of being clever here, you know, we view this as we believe we'll look back on this as a blessing in disguise from a focus benefit of our sales organization because one rep selling four tests. Resolve is a great test that has been broadly adopted but it requires focus and time with our customers and obviously our organizational support of that. Dan Brennan (Equity Analyst at TD Cowan) Okay, great. Thanks. Michael McGarrity (Chief Executive Officer) Thank you Dan. OPERATOR Thank you. We go next now to Bill Bonello with Craig Hallam. Bill Bonello (Equity Analyst at Craig Hallam) Hey guys, thanks for taking the Question. I want to focus a little bit on the cash situation here. So when you think about the, you know, restructuring expenses that you're going to incur, do you have any sense of the magnitude of the cash outlay that may go along with that? Michael McGarrity (Chief Executive Officer) Yeah, Bill, I think we're, we're confident that our expectation would be the operation would cease by the end of June. Obviously, the majority of the Plano operation is carried in cogs, but we expect to derive any additional expense associated with that will be absorbed by additional efficiencies across our operation that has adjacent or I guess, you know, blended support of our Resolve business in our operation across RCM client services and shared services with operation and product support. So I guess that hopefully that answered Bill Bonello (Equity Analyst at Craig Hallam) your question, if I understood your question. I mean, somewhat, I mean, it just, you know, you've got, you've got, I just want to make sure I understand that. I mean, there's going to be some, some severance payments you're going to be making, there's charges on the lease that you mentioned, etc. Those are all cash. And so you're thinking you can offset that cash outlay that, you know, may come over the next couple of quarters. You can completely offset that with enhancements to the rest of the business. Michael McGarrity (Chief Executive Officer) We're confident that there'll be a considerable offset there, Bill. Okay. And then when I think about the only term I use differently was that completely, I mean, whether it's completely materially offset. Yep. Just for transparency. Bill Bonello (Equity Analyst at Craig Hallam) Yep. Okay. And then just when I look at the, at the, at the pro formas and I think, you know, there's maybe 700 and something thousand dollars of expense that you. Put with Resolve. Can you give us some sense of what, what those expenses are just, and, and what I'm trying to get at here is, you know, how easy will it actually be to eliminate operating expense? What's truly attached to Resolve? And, and what was, you know, just, you know, covering fixed costs, Michael McGarrity (Chief Executive Officer) mainly incentive comp, Bill, through our sales organization for the Resolve test, if I'm under that question correctly. And again, as we, you know, we're not in a position right now to fully reconcile. But to your two part question, we expect the majority of the offset of the closing of the operation, the associated cost with that to be offset by efficiencies across the organization. And from an OPEX perspective, while I noted that the majority of opex, that OPEX will not change materially because the majority of the Plano carry was in cogs, we would expect some benefit IC is a good example. Right. To our sales program. Bill Bonello (Equity Analyst at Craig Hallam) Okay, that's really helpful. And then just I guess if I can and I'll get out of the way and let other people ask questions, but just on the tissue volume, just trying to get a better understanding of what's going on there. It's been sort of moving steadily downward. And I know you've been doing a big integration and Salesforce was distracted by that. But it's sort of hard to believe at these trends that there's nothing else at all happening. So I guess I'm just trying to get what can you tell us about whether you're actually been losing some customers on the GPS side or maybe people are not continuing to use confirm or why are we seeing volume actually going down? Yeah, so I think I understand the question. I think I would say there's a multifactorial impact there. Right. We have made significant progress as I've noted, and based on our trending consistent growth profile is sticky adoption. There are aspects of our tissue based test that require focus and continued work with our customer base with both confirm and gps. You commented on the integration, which I fully anticipated and we expect clearly reflected in our guidance to see sequential acceleration on the tissue side, even with the focus required on this new development related to resolve on the tissue side in Q3, Q4, Q2, Q3 and Q4 as we go forward. And that's part of the calculus that we understand with our mapping of our customer base, our utilization rates, the implied churn or whatever that we would have. And we've made so much progress on that over the last couple years that we're confident that sticks. And as we look at the comp quarter that Dan noted, we would attribute it to those multiple factors. And our guidance requires that that comes back online on the tissue side as we anticipated at the beginning of the year. Knowing that Q1 would be choppy. Sure. Okay, thank you. OPERATOR Thank you, Bill. Mark Massaro (Equity Analyst at BTIG) Thank you. And just a quick reminder, everyone, Star one for questions today. We'll go next now to Mark Massaro with btig. Michael McGarrity (Chief Executive Officer) Hey guys, thank you for taking the question. I apologize. I hopped on the call a few minutes late, so I wanted to just ask a clarifying question. You know, I saw from your press release that you received a Medicare recoupment decision from Novitas, but I wanted to ask, did you receive a non coverage determination? So I'm just the clarification is, is the coverage suspended at this time? Mark? My answer to that is we've not. I don't know that Novitas has a coverage policy which you're very experienced in this segment. I mean, I don't. I think I commented, you know, Moldeax or California Mac has a clear policy related to UTI testing. Novitas does not. There have been communications that have come out over time, kind of over the last year or two where they're calling attention to it and focused on fraud and abuse. I think this is government down and I think that Moldyx has probably held up as well, difficult to navigate through Moldy X. We've experienced that, that they have a standard, a policy coverage. We have followed the AMA guidelines and the guidelines associated with how we have billed Novitas and Medicare for the past five years, Mark. And we know, I think, you know, you would probably know this too from landscape perspective. We know we're not alone here. Mark Massaro (Equity Analyst at BTIG) In fact, I would add an additional point here that we have urology customers that have brought UTI testing in house Michael McGarrity (Chief Executive Officer) through whatever methodology they're using or platform. And they are coming to us saying that they are experiencing reimbursement and are looking to bring reimbursement challenges, inconsistencies. But we don't have a policy to lean on to explain their behavior. And we are very confident. To my opening comment, which you missed, we can follow up that medical necessity is unquestioned and a very ambiguous, seemingly change in their posture on paying tests they paid for over time. Okay, thank you for clarifying that, Mike. We are not willing to try different billing schemes. We're just making what we believe is the prudent near and long term decision for our company and for all of our stakeholders to maintain our transparency and integrity. Mark Massaro (Equity Analyst at BTIG) It's unfortunate. Michael McGarrity (Chief Executive Officer) It's remarkably unfortunate because the value of OPERATOR patients and the way we've responsibly marketed this test. Dan Brennan (Equity Analyst at TD Cowan) Okay, so I understand why you made the decision to cease operations in Texas, but did you guys evaluate the option to run the test out of a separate lab in a Medicare jurisdiction that does have coverage? Michael McGarrity (Chief Executive Officer) Yeah, Mark, I don't think I'd comment anymore on all of the complex decision making process that we went through. So I don't really have a comment. I mean, our Irvine Laboratories in Moldiac Switch has a non coverage decision for UTI test. Yep. All right, and then last one for me. Are you seeing any, you know, as a follow up to Bill's question on the tissue volume side, are you seeing any changes in the competitive landscape that you can speak of? Nothing material from the two competitors on the GPS side. Okay, thank you for the time. Thank you, Mark. Thank you. We'll take a follow up question now from Dan Brennan at TD Cowan. Dan Brennan (Equity Analyst at TD Cowan) Hey guys, maybe just one more since, you know, we'd probably follow up later. Just. Michael, to your point on the tissue volume acceleration, can you just elaborate a little bit in terms of some of the initiatives and efforts that you kind of discussed in terms of seeing that sequential acceleration, any color, qualitative color, you can provide just about the visibility confidence in that acceleration. Thanks. OPERATOR Yeah, I mean I think maybe to provide to Mark's last question, you know, the one competitive landscape change I should H have noted, Mark is on the AI G side and I think there's a lot H of discussion, I don't want to say G noise, but awareness of and communication about the promise of AI in our space particularly relevant to gps. And what I noted in our strategy H here going forward, including the partnership that we've entered into, is that we've been G very patient and rigorous in our process as to the best path forward. H We have not been asleep at the wheel, but we've also not panicked. G I think we've gone through a prudent exercise of our operational value and use H of AI which does drive, as I noted, all of our clinical data generation and study protocols. G But more importantly the partnership that we've entered into when I know customer facing, you know, my comment would be there H is that they, this partner provides relevant G urology pathology services to our common customer base. H So we are very, very confident that our patient approach there. G There's not a company in the space that has been partnered with or available H with AI technology that we haven't spoken to, evaluated. And we're very confident that the efforts we're taking internally and the partnership that we have embarked on will drive significant, Significant support for our GPS and confirmed business. But that coupled with our execution focus of the sales organization, I guess those are the couple two or three different G basis that we have for being confident that tissue begins to accelerate as we go forward. F Got it. Okay, thank you. B Thank you. And gentlemen, it appears we have no further questions today. So ladies and gentlemen, that will bring us to the conclusion of today's MDX Health first quarter 2026 earnings conference call. We'd like to thank you all so much for joining us today and wish you all a great rest of your day. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga: MDXHEALTH (MDXH): Free Stock Analysis Report This article MDxHealth Reports Q1 2026 Results: Full Earnings Call Transcript originally appeared on Benzinga.com ᄅ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Investor releaseQuarter not tagged2026-05-14MDxHealth Q1 Earnings Call Highlights
MarketBeat
MDxHealth Q1 Earnings Call Highlights
Interested in MDxHealth SA? Here are five stocks we like better. MDxHealth is exiting its Resolve UTI business and plans to close its Plano, Texas lab, citing reimbursement uncertainty and a dispute with Medicare administrator Novitas, which has sought up to $10.4 million in recoupments. Management said the move will let the company focus on its core prostate cancer diagnostics franchise. For Q1 2026, the company reported $27.4 million in revenue as reported, while pro forma revenue for the ongoing prostate cancer business was $23.9 million, up 11%. It also ended the quarter with $43.2 million in cash and equivalents, before a $15 million earn-out payment made in April. MDxHealth reset its full-year outlook for the core cancer business to $110 million to $115 million, implying 20% to 26% growth, and said it will concentrate sales and investment on Confirm, GPS and ExoDx. Management also highlighted AI-focused initiatives and expects tissue volumes to accelerate later in the year. MDxHealth (NASDAQ:MDXH) reported first-quarter 2026 revenue of $27.4 million while announcing a strategic exit from its Resolve UTI testing business and the planned closure of its Plano, Texas, laboratory facility, a move executives said will sharpen the company’s focus on prostate cancer diagnostics. Chief Executive Officer Michael McGarrity said the company’s growth strategy has helped transform MDxHealth into a urology-focused precision diagnostics business, with revenue increasing from $11 million in 2019 to $108 million in 2025. However, he said reimbursement uncertainty around Resolve made the business line unsustainable. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “As we prioritize the ongoing integration of ExoDx and the growth of our core prostate cancer business, we have made the strategic decision to discontinue our Resolve UTI offering and to cease operations at our laboratory facility in Plano, Texas,” McGarrity said. McGarrity said the Resolve test was designed for urology customers to help diagnose and treat patients with complex, multi-organism infections. But he attributed the decision to exit the business to “the increasingly uncertain reimbursement landscape,” specifically citing what he described as a recent policy reversal by Novitas, the company’s Texas Medicare administrator. → MP Materials Is Quietly Building a Rare Earth Powerhou…Read full documentShow less
Interested in MDxHealth SA? Here are five stocks we like better. MDxHealth is exiting its Resolve UTI business and plans to close its Plano, Texas lab, citing reimbursement uncertainty and a dispute with Medicare administrator Novitas, which has sought up to $10.4 million in recoupments. Management said the move will let the company focus on its core prostate cancer diagnostics franchise. For Q1 2026, the company reported $27.4 million in revenue as reported, while pro forma revenue for the ongoing prostate cancer business was $23.9 million, up 11%. It also ended the quarter with $43.2 million in cash and equivalents, before a $15 million earn-out payment made in April. MDxHealth reset its full-year outlook for the core cancer business to $110 million to $115 million, implying 20% to 26% growth, and said it will concentrate sales and investment on Confirm, GPS and ExoDx. Management also highlighted AI-focused initiatives and expects tissue volumes to accelerate later in the year. MDxHealth (NASDAQ:MDXH) reported first-quarter 2026 revenue of $27.4 million while announcing a strategic exit from its Resolve UTI testing business and the planned closure of its Plano, Texas, laboratory facility, a move executives said will sharpen the company’s focus on prostate cancer diagnostics. Chief Executive Officer Michael McGarrity said the company’s growth strategy has helped transform MDxHealth into a urology-focused precision diagnostics business, with revenue increasing from $11 million in 2019 to $108 million in 2025. However, he said reimbursement uncertainty around Resolve made the business line unsustainable. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? “As we prioritize the ongoing integration of ExoDx and the growth of our core prostate cancer business, we have made the strategic decision to discontinue our Resolve UTI offering and to cease operations at our laboratory facility in Plano, Texas,” McGarrity said. McGarrity said the Resolve test was designed for urology customers to help diagnose and treat patients with complex, multi-organism infections. But he attributed the decision to exit the business to “the increasingly uncertain reimbursement landscape,” specifically citing what he described as a recent policy reversal by Novitas, the company’s Texas Medicare administrator. → MP Materials Is Quietly Building a Rare Earth Powerhouse MDxHealth said it recently received communication from Novitas seeking up to $10.4 million in recoupments tied to historical Resolve testing claims. McGarrity said the company believes the action is “without merit” and is defending its position through the Medicare appeals process. During the question-and-answer session, McGarrity told TD Cowen analyst Dan Brennan that the matter may not be resolved for “a significant period of time” unless it is quickly decided in MDxHealth’s favor. He said the company does not anticipate liability or recoupment, but added that if there were any minimal recoupment, the company understands it would be amortized over five years. → Micron Investors Face a High-Stakes Moment After the Latest Rally McGarrity also defended the clinical value of the test, saying the company marketed Resolve specifically to urology customers and a defined patient population rather than for routine urinary tract infections. He said MDxHealth has “absolute certainty” in the medical necessity and clinical validity of its testing services. Interim Chief Financial Officer Ron Kalfus said that because the board’s decision to exit Resolve occurred in April, the Plano lab and Resolve business remain included in MDxHealth’s reported first-quarter continuing operations. The company also provided pro forma figures excluding Resolve to show the trajectory of its ongoing prostate cancer operations. For the quarter ended March 31, 2026, MDxHealth reported: Revenue of $27.4 million on an as-reported basis. Pro forma revenue of $23.9 million for its core prostate cancer operations, excluding Resolve, up 11%. As-reported gross profit of $16.6 million. Pro forma gross profit of $15 million, representing a 62.9% pro forma gross margin, compared with 68% in the first quarter of 2025. As-reported operating expenses of $23.9 million and an as-reported operating loss of $7.3 million. Pro forma operating expenses of $22.9 million and a pro forma operating loss of $7.9 million, compared with a pro forma operating loss of $4.7 million in the prior-year period. As-reported net loss of $8.9 million and a pro forma net loss of $9.4 million, compared with a pro forma net loss of $9.3 million in the first quarter of 2025. Kalfus said the year-over-year increase in pro forma operating loss was primarily related to the addition of the ExoDx business. He also said the difference in gross margin was primarily related to the mix between tissue and liquid tests. The company ended the quarter with $43.2 million in cash and cash equivalents. Kalfus said MDxHealth made a $15 million 2025 earn-out payment to Exact Sciences on April 15, which would bring pro forma cash as of March 31 to $28.2 million after accounting for that payment. MDxHealth established updated 2026 revenue guidance for its core cancer business, excluding Resolve, of $110 million to $115 million. McGarrity said that represents 20% to 26% year-over-year growth for the core cancer business. He said exiting Resolve allows the company to focus its sales organization on Confirm, GPS and ExoDx, its prostate cancer diagnostic menu. McGarrity said the company had completed strategic mapping and cross-training of its expanded sales force during the first quarter and met an internal goal of transitioning SelectMDx customers to ExoDx. “By streamlining our operations and removing the reimbursement noise associated with the UTI business, we are effectively resetting our growth trajectory,” McGarrity said. Asked by Craig-Hallum analyst Bill Bonello about cash costs related to the restructuring, McGarrity said the company expects the Plano operation to cease by the end of June. He said MDxHealth expects costs associated with shutting down the operation to be materially offset by efficiencies across the organization, though he stopped short of saying they would be completely offset. Analysts also questioned management about tissue test volumes. McGarrity acknowledged multiple factors affecting the tissue business, including the integration of ExoDx and the need for continued customer engagement around Confirm and GPS. He said the company expects sequential acceleration in tissue volumes through the remainder of the year, beginning in the second and third quarters. McGarrity said there has been no material change in the competitive landscape from the two competitors on the GPS side, but he noted increased discussion around artificial intelligence in the company’s market, particularly as it relates to GPS. Earlier in the call, McGarrity said MDxHealth had initiated an AI-focused strategic initiative to build a data platform across the company. He said the company aims to use its large base of biopsy tissue specimens to improve operating efficiency, clinical value and customer experience. He also cited the ProtecT Trial collaboration with the University of Oxford, saying the study protocol now includes AI-enhanced endpoints intended to improve the prognostic value of the GPS test. McGarrity said the company has also started a collaboration with a customer-facing digital innovation company to develop AI-enhanced offerings tied to its tissue tests. In response to a follow-up question from Brennan, he said MDxHealth had evaluated AI technology options in the space and believes its internal efforts and partnerships will support the GPS and Confirm businesses. MDxHealth, headquartered in Mechelen, Belgium, with a U.S. presence in Newton, Massachusetts, is a molecular diagnostics company focused on improving the accuracy of cancer diagnosis and treatment decision making through epigenetic biomarker assays. The company specializes in developing and commercializing tests that detect DNA methylation changes associated with urological cancers, enabling more precise risk stratification and patient management. MDxHealth's lead product portfolio includes ConfirmMDx and SelectMDx. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "MDxHealth Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

