MDxHealth (MDXH) Q1 2026 Earnings Transcript

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Date

Wednesday, May 13, 2026, at 4:30 p.m. ET

Call participants

• Chief Executive Officer — Michael K. McGarrity
• Interim Chief Financial Officer — Ron Kalfus

Takeaways

• Pro forma revenue (prostate cancer operations) -- $23.9 million, an 11% increase, with the Resolve UTI business excluded for continuity of future business modeling.
• As reported revenue -- $27.4 million, includes discontinued Resolve UTI segment activity for the period.
• Pro forma gross margin -- 62.9%, compared to 68.0% in the prior year; attributed by management to "tissue versus liquid mix."
• Pro forma operating loss -- $7.9 million, widened from a pro forma operating loss of $4.7 million in the prior year; primarily related to the ExoDx business acquisition.
• Pro forma net loss -- $9.4 million, nearly unchanged from $9.3 million in the prior year on a pro forma basis.
• Cash and cash equivalents (quarter-end) -- $43.2 million as of March 31, 2026.
• Cash adjusted for earn-out payment -- $28.2 million after the April 15, 2026, payment of $15 million to Exact Sciences, as referenced for investor modeling.
• Discontinuation of Resolve UTI business -- Ceasing both the product offering and Plano, Texas laboratory operations, directly due to "increasingly uncertain reimbursement landscape" and "recent policy reversal by...Novitas."
• Novitas recoupment communication -- Receipt of a demand for $10.4 million related to past ResolveMDx claims; company states it is "vigorously defending" its position through the "formal Medicare appeals process."
• Updated 2026 core cancer revenue guidance -- Company issued core business guidance (ex-Resolve) of $110 million to $115 million, representing 20%-26% projected growth.
• Strategic refocus on prostate cancer portfolio -- Management completed ExoDx integration, streamlined sales focus, and transitioned SelectMDx customers to ExoDx, aiming to "cement [its] position as the growth vertical in urology."
• AI-focused strategic initiative -- Deployment of a "company-wide AI data platform," including evidence of impact in a "landmark protect trial" with the University of Oxford and a partnership to develop customer-facing AI-enhanced offerings.

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Risks

• Management disclosed the company received a $10.4 million recoupment demand from Novitas related to retrospective ResolveMDx claims, creating near-term reimbursement and legal uncertainty.
• Pro forma gross profit for the quarter was $15 million, yielding a pro forma gross margin of 62.9% compared to 68.0% for fiscal Q1 ended March 31, 2025, with the difference primarily related to tissue versus liquid mix.
• The pro forma operating loss widened to $7.9 million from $4.7 million, primarily due to ExoDx acquisition expenses, indicating profit challenges amid integration.
• Management acknowledged tissue test volumes have been "moving steadily downward," and while sequential acceleration is expected, this represents a volume risk if not achieved.

Summary

MDxHealth (NASDAQ:MDXH) is discontinuing its Resolve UTI test and associated laboratory operations in response to an adverse reimbursement shift and a $10.4 million recoupment claim from Novitas, redirecting strategic focus solely toward its prostate cancer diagnostics. Management reported 11% pro forma revenue growth in the core business but experienced a decrease in gross margins and an increased operating loss following the ExoDx integration. The company is initiating a company-wide AI data platform, highlighted by an AI component in its Oxford clinical partnership, with an updated 2026 core revenue target of $110 million to $115 million, or 20%-26% projected growth, exclusive of Resolve. Closing the Resolve business is intended to sharpen operational execution and redeploy resources to the prostate cancer portfolio.

• Management said the $10.4 million Novitas recoupment is being "vigorously" contested, and any remaining liability "would be amortized over a 5-year period," though no liability is anticipated by the company.
• The company communicated that operating cash will materially, but not entirely, offset restructuring costs from the Plano closure through enhanced efficiencies, though some cash charges will occur.
• Coverage for the Resolve UTI test is not suspended by explicit noncoverage but by the absence of a formal policy; management noted, "we do not have a policy to lean on."
• Competitive dynamics on the tissue (GPS) business remain "Nothing material," except heightened industry focus on AI, according to management.
• All Resolve customer accounts, consisting exclusively of urology practices, are being actively transitioned to the core prostate cancer menu.
• Management expects sequential improvement in tissue testing volumes beginning in fiscal Q2, underpinned by sales force refocus and the effect of AI-enhanced customer initiatives.

Industry glossary

• Novitas: A Medicare Administrative Contractor (MAC) responsible for claims processing and coverage decisions in certain U.S. regions, critical for reimbursement of laboratory-developed tests.
• Recoupment: A demand by a payer to return previously reimbursed funds for claims deemed unpayable upon retrospective review, frequently triggering legal contest or appeals.
• Pro forma: Adjusted financial presentation excluding discontinued or non-core operations to reflect ongoing business economics.
• GPS test: Genomic Prostate Score assay used for risk stratification in prostate cancer diagnostics.
• ExoDx: Liquid biopsy platform acquired by MDxHealth, central to the company's non-invasive urologic diagnostic offering.

Full Conference Call Transcript

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.

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