MDxHealth Q2 2026 Earnings Call - Resolve Wind-Down Complete and Core Urology Business Accelerates

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, Advisor, LifeSci Advisors: 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, Chief Executive Officer, MDxHealth: 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, Interim Chief Financial Officer, MDxHealth: 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, Chief Executive Officer, MDxHealth: Thanks, Ron. When speaking with stakeholders following our Q1 results, I noted that while the decision to discontinue Resolve UTI 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 Category 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 mdx 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, Analyst, Lake Street: 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, Chief Executive Officer, MDxHealth: 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, Analyst, Lake Street: 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, Chief Executive Officer, MDxHealth: 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, Analyst, Lake Street: Great. I appreciate that. Thank you.

Michael McGarrity, Chief Executive Officer, MDxHealth: Thanks, Thomas.

Operator: We’ll take our next question from Dan Brennan with TD Cowen. Your line is open.

Dan Brennan, Analyst, TD Cowen: 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, Chief Executive Officer, MDxHealth: 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, Analyst, TD Cowen: 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 Sciences 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, Chief Executive Officer, MDxHealth: 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.

Dan Brennan, Analyst, TD Cowen: Terrific. Okay, guys. Thanks a lot.

Michael McGarrity, Chief Executive Officer, MDxHealth: Thank you, Dan.

Operator: We’ll take our next question from Bill Bonello with Craig-Hallum. Your line is open.

Bill Bonello, Analyst, Craig-Hallum: 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, Chief Executive Officer, MDxHealth: 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 6-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, Analyst, Craig-Hallum: 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, Chief Executive Officer, MDxHealth: 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, Analyst, Craig-Hallum: 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, Chief Executive Officer, MDxHealth: I’m not sure I. Go ahead.

Ron Kalfus, Interim Chief Financial Officer, MDxHealth: Bill, I don’t think we can because pro forma would be comparing ExoDx to Select mdx, 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, Analyst, Craig-Hallum: I was trying to think of Exo last year versus Exo this year.

Michael McGarrity, Chief Executive Officer, MDxHealth: Oh, I see.

Bill Bonello, Analyst, Craig-Hallum: To get that picture.

Michael McGarrity, Chief Executive Officer, MDxHealth: 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, Analyst, Craig-Hallum: Okay. Thank you very much.

Michael McGarrity, Chief Executive Officer, MDxHealth: Thank you, Bill.

Operator: We’ll take our next question from Mark Massaro with BTIG U.S. Bank. Your line is open.

Mark Massaro, Analyst, BTIG U.S. Bank: 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, Chief Executive Officer, MDxHealth: 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 ExoDx 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.

Mark Massaro, Analyst, BTIG U.S. Bank: 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, Chief Executive Officer, MDxHealth: 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 2-3 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, Analyst, BTIG U.S. Bank: 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, Chief Executive Officer, MDxHealth: 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, Analyst, BTIG U.S. Bank: That sounds good. Thanks for the time.

Michael McGarrity, Chief Executive Officer, MDxHealth: Thank you, Mark.

Operator: Once again, for your questions, that is star 1. We’ll move next to Matt Larew with William Blair. Your line is open.

Matt Larew, Analyst, William Blair: 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 ExoDx 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, Chief Executive Officer, MDxHealth: 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 mdx 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, Analyst, William Blair: 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.

Michael McGarrity, Chief Executive Officer, MDxHealth: 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.

Matt Larew, Analyst, William Blair: Okay. Thank you.

Michael McGarrity, Chief Executive Officer, MDxHealth: 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.