Myriad Genetics - Q4 2025
February 23, 2026
Transcript
Operator (participant)
Good day, and thank you for standing by. Welcome to the Myriad Genetics fourth quarter and full year 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Matt Scalo, Senior Vice President of Investor Relations. Please go ahead.
Matt Scalo (SVP of Investor Relations)
Good afternoon, and welcome to Myriad Genetics' fourth quarter and full year 2025 earnings call. During the call, we will review the financial results we released today, and afterwards, we will host a Q&A session. Our earnings release was issued this afternoon on Form 8-K and can be found on our website at investor.myriad.com. I'm Matt Scalo, Senior Vice President of Investor Relations. On the call with me today are Sam Raha, our President and Chief Executive Officer, Ben Wheeler, our Chief Financial Officer, and Mark Verratti, our Chief Operating Officer. Also joining us for Q&A will be Brian Donnelly, our Chief Commercial Officer. This call can be heard live via webcast at investor.myriad.com, and a recording will be archived in the investor section of our website, along with this slide presentation.
Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the SEC, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause actual results to differ materially from those contained in our projections or forward-looking statements. I will now turn the call over to Sam.
Sam Raha (President and CEO)
Thanks, Matt. Good afternoon, everyone, and thank you for joining us. As we head into the new year, I'm pleased with the progress we're making as the new Myriad Genetics to live up to our significant potential by focusing on high-growth market segments, advancing our plans for multiple timely product launches, including leveraging strategic partnerships, and by executing with stepped-up urgency and strengthened execution rigor. I'm happy with how we ended 2025, with fourth quarter revenue of $210 million, coming in above the high end of the pre-announced range we provided in January. When you exclude the headwind from UnitedHealthcare's decision on GeneSight, our business grew approximately 4% over Q4 of 2024. In terms of testing volume, we delivered 382,000 test results in the fourth quarter.
Our financial results were supported by continued strong volume growth for MyRisk in oncology at 14% over the year-ago quarter and MyRisk for unaffected at 11% over the year-ago quarter. These results reflect our ongoing efforts to enhance the customer workflow, including EMR functionality. Mark will provide additional color in his section, but certainly, we continue to see positive demand for our MyRisk urinary cancer test, and this supports our accelerated, profitable growth journey ahead. I'm also pleased to call out the acceleration in Prolaris test volume growth in the fourth quarter, where the combination of actions over the last two quarters, including incremental investments in the commercial team focused on urologists, have helped drive 12% test volume growth year-over-year. Fourth quarter prenatal volume declined year-over-year, primarily stemming from Q2 order management disruption.
With this issue resolved, we are now in an active rebuild phase, reactivating accounts, expanding access, and driving new customer wins. We expect these actions to support a return to positive growth in 2026. Moving to our mental health business, GeneSight volume grew 9% year-over-year and continued to accelerate from the first half of 2025 as our commercial organization maintained strong execution with new and existing customers. For the full year of 2025, revenue was $824.5 million, and we delivered over 1.5 million test reports by serving over 55,000 healthcare providers. Turning now to profitability. In the fourth quarter, we reported strong adjusted gross margin of 70% and closely managed our discretionary spend, as reflected in our adjusted OpEx line.
Ultimately, we reported healthy adjusted EBITDA of $14.3 million and adjusted EPS of $0.04. We're also making great progress on our cancer care continuum strategy to maintain leadership for urinary cancer testing while expanding into other attractive cancer testing applications. This includes launching the expanded MyRisk panel in Q4, which has been well received in the market. We're also sharing results from an increasing number of studies on Precise MRD, with positive clinical data presented at major clinical conferences. We're in final preparation mode to start commercial testing of Precise MRD for breast cancer for a select set of customers in what we call an alpha launch, starting next week. Overall, we're making good progress towards our goal of expanding our portfolio of differentiated testing solutions that provide actionable insights across the cancer care continuum.
From a new product pipeline perspective, 2026 is shaping up to be a banner year. Throughout the year, there are a number of important catalysts that we will be tracking that supports this year's growth. Even more, these are leading indicators of key growth drivers for 2027 and beyond. We're making significant progress on a number of catalysts outlined in this slide. Our strong fourth quarter test volume growth for MyRisk reflects ongoing traction of our breast cancer risk assessment programs and the launch of our expanded MyRisk test. We plan to launch disease-specific panels for MyRisk in Q2, and expect our market activation programs and product extensions to support increased MyRisk growth.
Building on Prolaris's strong fourth quarter performance, we're on track to launch our first AI-enhanced Prolaris prostate cancer test in Q2 that combines the power of molecular and AI analysis. This is based on our partnership with PathomIQ. On Precise MRD, as I noted earlier, we're on track to commence commercial testing for a select set of customers next week, and I'll provide additional color on the next slide. At J.P. Morgan Healthcare Conference in January, we reconfirmed that our first Precise MRD test will be for breast cancer and announced additional indications that will follow. We plan to submit for MolDx and expand commercial testing for early access customers for both renal and colorectal cancer in the second half of the year, with commercial launch of breast, renal, and colorectal planned for 2027.
All of these Precise MRD tests have a growing body of clinical validation, some of which has been shared recently in venues, including presentations at the San Antonio Breast Cancer Symposium in December, ASCO Gastrointestinal Cancers Symposium in January, where a first look at Precise MRD data related to colorectal cancer was presented by collaborators from National Cancer Center Hospital East in Japan, showing how the ultrasensitive detection of Precise MRD can have additional benefits compared to first-gen MRD tests. To round out the robust 2026 pipeline, we're on track to launch FirstGene multiple prenatal screen tests in the second half of this year. The timing of this launch dovetails nicely with the deployment of a focused prenatal health sales team next quarter, and the expected early results of the CONNECTOR study in the next few months.
As we prepare to achieve the important milestone of commencing commercial testing for a select set of customers with Precise MRD for breast cancer patients next week, I want to help frame expectations at this stage. This slide highlights our three objectives. First, we're looking to further showcase Precise MRD's clinical performance while continuing to build a body of real-world evidence. To date, data shows Precise MRD's high sensitivity and ability to detect disease down to one part per million. We believe our MRD platform can help guide clinical decision-making for patients in their journey in cancer care, and has the ability to detect presence and recurrence meaningfully earlier than the standard of care with imaging, and therefore can positively impact patient outcomes. Second, nearly 85% of cancer care in the U.S. happens in the community.
That's where Myriad has a strong, established presence, where we serve nearly 3,500 oncologists in 2025. We've seen strong interest from our community oncologist base to participate in the alpha and early access stages of our commercial rollout. Clearly, this is an encouraging sign, but we also remain disciplined regarding the overall number of participating centers in these early stages of launch to ensure good customer experience and manage our profitability. We will look to expand the number of centers as we move through 2026. The third objective is to track and learn from specific metrics appropriate for this early stage. After all, you get what you measure, and we'll look to provide an appropriate level of visibility into these metrics moving forward, starting with the Q1 earnings call.
While we're excited and busy preparing for multiple launches this year, I want to reiterate that there is little to no contribution from these MRD tests in our 2026 revenue guidance. Going into 2026, we're taking a number of actions to accelerate growth. This includes our plan to invest over $35 million over the next few years to support a number of initiatives to accelerate organizational efficiency, agility, and growth. These initiatives include strengthening our commercial capabilities, particularly in the cancer care continuum. Specifically, we're adding a meaningful number of sales and medical headcount ahead of multiple new product launches this year. Many of these new additions come from advanced diagnostics sector and bring strong domain knowledge and experience in molecular profiling and cancer diagnostics, along with relationships across the oncology healthcare community.
In addition, we're strengthening the tools critical to our sales team, while implementing a comprehensive plan to drive awareness, excitement, and demand for our products. I attended our commercial kickoff meeting last month, hosted by Brian Donnelly, Chief Commercial Officer, and I can say our teams are energized and highly motivated to win in the market. Now, let me hand it over to our COO, Mark Verratti. Mark?
Mark Verratti (COO)
Thanks, Sam. Turning to fourth quarter oncology. Total oncology revenue was $84.7 million, growth of 2% over the fourth quarter of 2024. I would like to highlight our MyRisk test continues to gain share with fourth quarter 2025 year-over-year volume growth of 14% in the affected market and 11% in the unaffected market. Shifting to prostate cancer, Prolaris revenue growth in the fourth quarter accelerated to 16% year-over-year, up from 3% year-over-year revenue growth in our third quarter. Fourth quarter Prolaris revenue growth was driven by 12% volume growth, reflecting a continued improvement year to date. As mentioned on previous calls, we are investing in the commercial channel and other programs to grow and regain share in this market.
Adding to what Sam mentioned in previous calls, Myriad is on track to be the only company that will offer AI, biomarker, germline, and tumor profile testing when we launch our first AI-enabled Prolaris test in the second quarter of 2026. In January, we issued a press release outlining our MRD commercialization timelines and clinical evidence presented at recent clinical conferences. Our ultrasensitive, Precise MRD test continues to demonstrate strong clinical value in these studies, which now includes data on colorectal cancer patients, where we saw 100% baseline ctDNA detection across all patients. Approximately 20% of samples were detected at levels in the ultrasensitive range that may have gone undetected on first-generation assays. This supports strong performance of Precise MRD. As Sam mentioned, we're excited to begin offering our ultrasensitive, Precise MRD test next week.
Initially, this launch will be limited to a number of oncology centers, ones we believe best reflect a variety of needs across the community oncology setting and breast cancer patients. This early launch provides the opportunity to engage these providers and incorporate their feedback about a host of topics, including the ease of use and overall utility and actionability of the test. We'll plan to expand the number of centers in a controlled manner until full commercial launch. Moving to our women's health business. In the fourth quarter, women's health delivered revenue of $88.5 million, an increase of 2% over prior year period. We're pleased to see another consecutive quarter of incremental growth in hereditary cancer testing in the unaffected market, with revenue growth of 3% and volume growth of 11% year-over-year.
This improving volume growth trend is particularly important as it reflects EMR-related workflow improvements put in place, such as the September integration of our MyGeneHistory assessment into Epic, as a way to better identify patients that qualify for hereditary testing and improve the provider experience. We continue to be optimistic about the potential for continued momentum. We also remain confident about our ongoing progress from breast cancer risk assessment programs that enable providers to rapidly identify patients who qualify for additional screening. We continue to see positive momentum at these sites and expect to make further investments in our commercial capabilities to accelerate this program through 2026 to fuel growth in MyRisk volume.
As for prenatal testing in the fourth quarter, we saw a modest pullback in volume growth from previous quarters as we continue to work with accounts affected by friction created by the second quarter implementation of a new test ordering system. While we are optimistic on our ongoing engagement, we'll win back share and drive overall growth in 2026. Prenatal volume growth in the first quarter of 2026 will face a difficult year-over-year comparison, likely leading to a decline in year-over-year volume growth. As for our new multiple prenatal screen, FirstGene, last week, we published the analytical validation of FirstGene in Clinical Chemistry. FirstGene is an integrated solution for multiple pillars of prenatal testing, and our paper shows excellent accuracy and reliability for each pillar.
We continue early access clinical testing with our CONNECTOR study seeing positive enrollment momentum, and we are pleased with our turnaround times, assay performance, and early customer feedback. We are reaffirming our full commercial launch in the second half of 2026 and are investing appropriately ahead of this launch as FirstGene provides added insight and has the potential to expand the overall addressable prenatal testing market. Turning now to mental health. In the fourth quarter, the team generated GeneSight revenues of $36.6 million on volume growth of 9% year-over-year. We continue to drive expansion of the ordering provider base, achieving a record number of ordering clinicians to over 38,000 in the fourth quarter. This strong fourth quarter volume performance is worth highlighting, as Myriad remains disciplined and focused on capital efficiency in this group.
While quarterly revenue continues to be impacted by UnitedHealthcare's coverage policy change in January of 2025, we are proud of our clinical development and payer market teams for securing positive coverage policies across 12 payers for GeneSight in 2025 related to biomarker laws, including the California Medicaid program, Medi-Cal. In addition, we are seeing benefit from optimizing revenue cycle workflows to maximize reimbursement. I will now turn the call over to our CFO, Ben Wheeler.
Ben Wheeler (CFO)
Thanks, Mark. As Sam and Mark highlighted, we're seeing clear momentum from the operational and commercial progress made throughout 2025. Let me start with a recap of our fourth quarter growth drivers. We generated another quarter of strong test volume growth in hereditary cancer testing, achieving 9% year-over-year growth in the fourth quarter and 7% year-over-year growth for the full year 2025. This acceleration in the fourth quarter reflects continued double-digit growth in our unaffected market. Likewise, GeneSight finished the year with strong momentum, generating test volume growth of 9% year-over-year in the fourth quarter and 6% for the full year 2025. This progress reflects commercial discipline and effectiveness of the actions taken in early 2025 in response to UnitedHealthcare's coverage decision.
The reacceleration in both unaffected hereditary cancer volumes and GeneSight volumes is a clear proof point that our commercial performance is strengthening, and that the actions that we've taken to enhance focus, accountability, and effectiveness are translating into tangible momentum. Moving to the consolidated financial results. For the fourth quarter, we reported revenue of $209.8 million, above the high end of the range pre-announced on January 12th, and consistent with the year-ago period. Overall test volumes grew 2% year-over-year, while average revenue per test declined 2% year-over-year. The headwind in fourth quarter average revenue per test reflects the impact from UnitedHealthcare's policy change with respect to GeneSight coverage. Despite the average revenue per test headwind, underlying demand continues to be strong.
Excluding UnitedHealthcare's net impact on GeneSight of $8.1 million, our underlying fourth quarter 2025 revenue growth rate was 4% year-over-year. We generated 70% gross margins in fourth quarter, in line with our third quarter, but down approximately 190 basis points year-over-year. This decline was driven by the revenue headwind I just mentioned that affected GeneSight average revenue per test. Fourth quarter adjusted operating expenses decreased by $7 million year-over-year, reflecting disciplined cost management and the timing of investment, as resources were deliberately redirected towards commercial and R&D initiatives that will ramp and be reflected in first quarter spending. We remain committed to balancing strategic investment to support our long-term growth with continued progress toward improving profitability, while ensuring capital is allocated to our highest impact priorities.
Taking all of that into account, we generated adjusted EPS of $0.04, or $0.01 above the year-ago period. Next, I'll speak to Myriad's profitability and liquidity. We generated $14.3 million of adjusted EBITDA and $17.9 million in adjusted operating cash flow in the fourth quarter. These results reflect the strength of our gross profit base, the operating leverage inherent in our business model, and the meaningful earnings and cash flow potential of the business as we continue to execute. We also maintain a solid balance sheet with access to $225 million in capital. As a note, we intend to file a universal shelf registration to replace our existing shelf. We view maintaining an effective shelf registration as a prudent corporate housekeeping measure. Next, I'll address financial guidance.
We're reaffirming our full year 2026 financial guidance, which we issued on January 12th, including a revenue range of $860 million-$880 million, an adjusted gross margin range of between 68% and 69%, as well as an adjusted EBITDA guidance range of between $37 million and $49 million. In order to support investor modeling for 2026 by quarter, we provided additional commentary in the earnings release, I would like to highlight a few key points. First quarter revenue is expected to be between $200 million and $203 million, representing 2%-4% growth over the year-ago period. As happens in most years, first quarter average revenue per test tends to be lower than fourth quarter due to items such as the resetting of insurance deductibles.
In addition, as Mark mentioned, prenatal volume and revenue are expected to face unfavorable year-over-year comparisons in the first quarter, leading to a year-over-year decline in this portfolio. We anticipate prenatal to demonstrate year-over-year progress, likely beginning in Q2. Also consistent with recent years, revenue in the second half of the year is typically stronger than the first half. We expect this pattern to repeat to a similar degree in 2026. This outlook is supported by current business trends, an anticipated improvement in prenatal portfolio, and early contributions from recent commercial investments. As a result, we expect quarterly revenue to grow sequentially from first quarter through the remaining quarters of the year.
I also want to make investors aware that beginning in 1st quarter, we plan to simplify how we present and discuss our business to better align with our refreshed strategy and how we're operating the company. Going forward, we'll organize our reporting around our strategic areas of focus, with the 1st group being the cancer care continuum. This group will incorporate all hereditary cancer testing, including both affected and unaffected populations, and all tumor profile testing.
This will be followed by prenatal health, which will include our NIPS and carrier screen lines, as well as SneakPeek. Lastly, we'll continue to report mental health as a distinct category. We are making these changes because it provides clear visibility into the core drivers of the business and better aligns our external reporting with how we operate and allocate resources to our strategic priorities. We're confident in our full year outlook and the team's execution as we enter 2026. Let me turn the call back to Sam.
Sam Raha (President and CEO)
Thanks, Ben. Let me conclude by saying this is an energizing time for the new Myriad. We are at an inflection point where we have the absolute clarity and conviction for our go-forward strategy, with a particular focus on the cancer care continuum. We have a robust pipeline of new products and enhancements for attractive market opportunities, mostly developed internally, but also complemented with ones enabled through strategic partnerships.
Yes, we are the hereditary cancer company, but we are more than that, and many of these new products will strengthen our position across cancer care testing. Along with that, we're going to leverage our operational strengths for sample processing and reporting while expanding our commercial capabilities and customer reach. We have a stronger leadership team now, both from my direct staff and the next level, the needed blend of diagnostics, cancer, and genomics domain knowledge, combined with proven experience for delivering results. Along with all this, we're taking steps programmatically and culturally to strengthen execution excellence. Put it all together, we have the substance and confidence to positively impact an increasing number of patient lives and to accelerate profitable growth. I now pass the call over to Matt for Q&A. Matt?
Matt Scalo (SVP of Investor Relations)
Thanks, Sam. As a reminder, during today's call, we use certain non-GAAP financial measures. A reconciliation of the GAAP to non-GAAP financial results, and a reconciliation of GAAP to non-GAAP financial guidance can be found in our earnings release and under the Investor Relations section of our website. Now we're ready to begin the Q&A session. To ensure broad participation, we're asking participants to please ask only one question and one follow-up. Operator, we're now ready for the Q&A portion of the call.
Operator (participant)
Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Puneet Souda of Leerink Partners. Your line is open.
Puneet Souda (Senior Managing Director and Senior Research Analyst of Life Science Tools and Diagnostics)
Yeah, hi, guys. Thanks for my questions here. First one, maybe, Sam, just given the momentum or the recovery that you're focused on for, you know, for the full year, do you, you know, I was trying to understand, what gives you confidence that we can continue with this sort of high single-digit long-term growth rate, you know, that you had before? What you're, what you're projecting for the year, is that how should we, you know, should we think about, you know, sort of 2027, can we or can we return back to that high single-digit growth rate? Let me just pause there, and I'll come back with another question follow-up.
Sam Raha (President and CEO)
Yeah, Puneet, thanks for the question. Well, first, let me start with 2026, and the, the drivers of our growth this year. Again, it's a number of products that we have already launched coming into the year, be it, the expanded MyRisk Panel in Q4 of last year. It's improvement that we're seeing across the board, both in commercial and other parts of our organization and execution, so we're getting better at that. We are also, you know, as we get along the year, we're adding headcount to go along with new products that we're launching and so forth.
You know, based on what we have, the recovery of the prenatal business that we anticipate, that we've spoken to, happening over the next several months and quarters, we, we feel confident being right there in our guidance range, right? That's what we feel for, for this year. Listen, when you look at 2027 and beyond, as I've said recently at, you know, the JPM conference in January, we believe that we have, you know, a number of levers in place. I'll again point you to the catalyst slide, which talks about a number of new products, right?
We have three major launches this year, starting with Precise MRD for breast and, you know, other indications as well, AI-enabled Prolaris for prostate cancer, as well as FirstGene, right? All of these things, I think, will be important, that we're timely in our launch, but truly, these become even more growth drivers through 2027 and beyond. I would summarize your second part of your question in that we have confidence that, you know, as we exit this year, going to 2027, 2028, that we will be on path for high single-digit to low double-digit, sustained, profitable growth.
Puneet Souda (Senior Managing Director and Senior Research Analyst of Life Science Tools and Diagnostics)
Got it. That's helpful. On the MRD launch, I appreciate the details you provided, but just wanted to get how do you plan on holding back? I mean, is it certain indications, just given the competitiveness of the market and competition in the market, and also the fact that currently the products are not reimbursed, but you're on a path towards that. Maybe just talk to us as to how you plan to throttle it back and then accelerate into the second half of the year and beyond. Then on prenatal, if I could just squeeze in, how should we think about the growth rate in the first quarter? I know it's down, but just wanted to make sure, if there's a finer point on that, and then the recovery through the rest of the year.
Sam Raha (President and CEO)
Yeah, let me take the MRD question. Then, Ben, if you can answer the prenatal question here. Yeah, from an MRD standpoint, we are excited again. As I said, it's next week, we're going live. We're gonna start commercial testing. It is for what we're calling our alpha phase of the launch, select number. We are being selective, Puneet. It is a little bit challenging in a good way, that we've seen a lot of interest to have access to Precise MRD. I believe we can do it in a balanced way.
I mean, again, in this phase, what we're looking for is input on the user experience, all the way from ordering to the reporting, the, the number of repeat orders, the operational efficiency that we have, and ultimately, the order volume that we have. As we've noted, our MolDx submission is planned for, you know, early H2, so you can call it Q3 for breast, and then later in 2026 for renal and colorectal cancer. Until we have submitted for MolDx, we're gonna be, you know, a little bit more careful on the volume we take on.
We have a path, and listen, it'll be, it'll be something we will carefully consider as the year goes by, of are there merits to increase the volume? You know, what do we think on the timing of MolDx? As we sit right now, we're, we're pleased, particularly with the start of alpha, for Precise MRD and breast, next week. Ben, over to you on prenatal.
Ben Wheeler (CFO)
Thanks, Sam. As, as it relates to prenatal need, you know, as a policy, we, we don't generally offer product-level revenue guidance, but we did call out the prenatal Q1 growth and the unfavorable year-over-year comparison, because we had noticed that the street revenue models had a pretty wide range as it related to our prenatal product. We thought it was important to be able to, to make sure that folks understood that appropriately reflecting our expectation as it relates to the recovery in 2026 is really the only major change needed to get Q1 revenue in line with our updated revenue range of $200 million-$203 million.
Sam Raha (President and CEO)
Got it. Awesome. All right. Thanks, guys.
Operator (participant)
Thank you. Our next question comes from Subbu Nambi of Guggenheim. Your line is open.
Subbu Nambi (Managing Director and Senior Analyst)
Hey, guys. Thank you for taking my question. At JPM, you laid out an ambitious MRD launch roadmap, which you reiterated today. As you think about the puts and takes in that roadmap, where is there the most risk or the most factors out of your control that could delay your roadmap? Conversely, are there things that would go faster than what you planned?
Sam Raha (President and CEO)
Yeah, thank you, Subbu, for, for the question. In fact, when we, when we think about this year, one of the biggest challenges, if you will, and I think it could be a positive thing, is exactly how many samples in advance of MolDx approval that for, for Precise MRD that we run. You know, the, some of the, the things that are, as you're asking, out of our complete control are, are just how long and how many cycles it might take MolDx to do the review, provide us input, and ultimately for us to get approval. What we can control, and I think we've been doing a really nice job of, is preparing the data and for the submission for the publication. I think I, I've shared before, we have more than 15 active studies in MRD underway.
The MONITOR-breast study is the one which will inform and provide the publication for breast cancer MRD, and, you know, that, that is on track for us to be able to do that in Q3. Now, the, for the colorectal cancer submission to MolDx, that's tied, that's part of the pan-cancer study. It's part of the MONSTAR-SCREEN-3 study that we're doing with our collaborators in Japan. We believe that's on track for the second half, which will, you know, be the submission to colorectal.
Now, in renal, you know, the good news is we in September of last year, we already had a publication in The Lancet for renal cell carcinoma. Those things on submissions, yeah, that's just to speak to, you know, kind of our level of confidence. We have, I think, a decent level of control. It's really about the MolDx timing. As you know, Subbu, we'll, we'll, we'll kind of walk that road together. We'll see how that goes.
Subbu Nambi (Managing Director and Senior Analyst)
Thank you so much for that. One follow-up. Last week, you published a paper of performance data for FirstGene in a prospectively collected set of patient samples. You reiterated the timing for CONNECTOR study in second half of this year, which will be based on real-world samples. Is there any reason to expect the real-world data set to have meaningful difference in performance of the test and the prospectively collected samples?
Sam Raha (President and CEO)
Thank you. Thank you for, for the great question. First, yeah, we were very pleased with the results, both on selectivity and sensitivity, from, you know, about 500 samples that we noted in the press release last week. We, you know, until the data is fully there from a broader set of, CONNECTOR, individuals who are enrolled in CONNECTOR, we can't conclusively say, but there is, we see no reason to believe that the data shouldn't be as robust and compelling in terms of, you know, the performance for FirstGene.
Subbu Nambi (Managing Director and Senior Analyst)
Perfect. Thank you so much, guys.
Sam Raha (President and CEO)
Thank you.
Operator (participant)
Our next question comes from Tycho Peterson of Jefferies. Your line is open.
Tycho Peterson (Managing Director and Senior Equity Analyst)
Hey, thanks. couple on margin. If, if we look at, you know, HCT volumes in oncology, you grew 9%, revenue, obviously only increased 3%. Maybe just talk about what specific ASP or payer mix dynamics, you know, are driving this gap, and, and how do we think about this kind of dynamic in, in 2026 as you launch disease-specific panels?
Ben Wheeler (CFO)
Tycho, this is Ben. Thanks for the question. As we talked about ASP in Q3, we talked about that kind of via the launching point for Q4, and then moving forward into 2026, I think it's important for folks to take into account that we anticipate a modest headwind relative to ASP when we look at the portfolio in 2026, when you're thinking about what the year will look like. As you mentioned from a payer mix standpoint, as we focus on selling the expanded panel and then also the MyRisk more broadly across our sales channels, we've talked about this before, where we have about a 10% lighter ASP in the unaffected channel relative to the affected channel.
I think that we saw that, that headwind across the portfolio, from an ASP standpoint, when you look at 2025, really driven by the different mix of payers. Part of it was biopharma revenue that we talked about in. Excuse me, in Q3, with the new baseline moving forward. Then another part of it is you just see a shift in the different payer mix from 1 payer group, from a Blue Cross Blue Shield group to another group or something along those lines.
Tycho Peterson (Managing Director and Senior Equity Analyst)
Okay. Then on Precise, appreciate, you know, the color on kind of the alpha rollout. Maybe just talk a little bit about how you think about scaling up on the sales and commercial channel there. Obviously, more of a, you know, 2027 driver overall, but just talk a little bit about how you're thinking about, you know, hiring for the various indications.
Sam Raha (President and CEO)
Yeah, sure. Maybe I'll start, and then I'll allow Brian Donnelly, who's, who's here with us, to join in. I'll just say that the scale-up and the preparation for the launch has been underway for some time, and it includes, you know, training the existing team, making sure we're hiring people with the right profile, meaning understanding of molecular, and, you know, beyond just the sales team, it's also our medical folks, MSLs, and a lot of that's already happening. Brian, please.
Brian Donnelly (CCO)
Yeah. Thanks, Sam. Hey, this is Brian. Just, just building on what Sam has said, we're really focused on making sure we have the right level of reach and frequency to priority targets, which you won't be surprised to hear us say. We're just taking a consistent view at the market, making sure that we are hiring the right level of folks in the right territories, and we're training them, which is a really important piece of the puzzle. We want to get them ready to go as quickly as possible to make an impact.
Sam Raha (President and CEO)
Yeah, and Tycho, I'll just add to that. We've mentioned, I mentioned again earlier in my prepar- prepared remarks, that we're spending over $35 million over the next couple of years, and, you know, a, a very big part of that is to augment our, our sales team. Those additions are underway as we speak. In fact, we had our commercial meeting kickoff just a couple of months ago, and there's a lot of new faces in the room. They're coming from places where they've done this already, so they're not just going to be learning on the job.
Tycho Peterson (Managing Director and Senior Equity Analyst)
Okay, that's helpful. Then maybe just along those lines, and lastly, just on the, on the alpha launch, can you just provide any more color? You talked a little bit about how you're thinking about number of tests you need to run, but maybe the customer profiles you're going to be targeting.
Sam Raha (President and CEO)
Sorry, I didn't know if you got cut off, but, yeah, did you just say, can I provide any more color? Is that what you just mentioned there?
Tycho Peterson (Managing Director and Senior Equity Analyst)
Oh, yeah, on the alpha launch. I mean, you talked about number of tests you may target, but in terms of.
Sam Raha (President and CEO)
Okay, I'm gonna go with that. Hey, listen.
Operator (participant)
Ladies and gentlemen, please remain on the line. Your conference will resume shortly.
Tycho Peterson (Managing Director and Senior Equity Analyst)
Hello, are we back?
Operator (participant)
I am hearing you again.
Sam Raha (President and CEO)
Okay.
Operator (participant)
You may proceed.
Brian Donnelly (CCO)
Hey, Dee Dee, sorry, we got cut off in the room.
Sam Raha (President and CEO)
Yeah, apologies, Tycho. I got cut off. I think what I was answering your question about alpha is, you know, we're excited about the launch. We're starting off with a handful of community oncology centers, and by the end of the year, as we move into early access, we're going to broaden that into dozens of actual accounts. We have already done the training to prepare these sites. We have sample collection kits in their hands, we're looking forward, starting next week, to, you know, activate fully and start receiving samples and can't, can't share enough the excitement that we have to start.
Tycho Peterson (Managing Director and Senior Equity Analyst)
Thank you.
Operator (participant)
Thank you. Our next question comes from Doug Schenkel of Wolfe Research. Your line is open.
Doug Schenkel (Managing Director, Senior Research Analyst, and Head of Life Science and Diagnostic Tools)
Thank you for taking my questions. My first one is on Prolaris, where ostensibly you've picked up some momentum into your end. As you noted in your prepared remark, the reason volume was up, was up low double digits was because of the favorable comparison. Can you delineate between how much of it was the comp versus improved rep productivity or any other dynamics that you think are worth calling out? That's my first question. On an unrelated topic, my other question is prenatal momentum into your end. Units were actually down, I think, 5,000 or so sequentially in the fourth quarter.
Andrew Cooper (Director of Equity Research for Life Science Tools and Services and Diagnostics and Clinical Laboratories)
I just want to see if there were any remaining order management dynamics, and if so, you know, how is that contemplated into 2026 guidance? Beyond that, you know, are there other things that are worth talking through, like competitive dynamics, for example, that may have affected trends into year-end? Thank you very much.
Sam Raha (President and CEO)
Yeah, thank you, Doug, for the questions. Let me, let me start with the question on Prolaris, and then I'll hand it off to the combination of Ben and Brian to talk about prenatal. Listen, there, there have been a number of activities that we've been working on over the last few quarters, actually, related to Prolaris. It includes the engagement we've had with KOLs, it includes the various programs we've been driving. It includes the expansion of our sales team, into more serving more urologists.
All of those things are, are things that we think will endure. Now, yeah, did we, you know, potentially get a little bit of a compare benefit in, in Q4? That's possible. As we look into 2027, we expect, you know, you know, maybe not the 12% growth that we had within the quarter, but much stronger and actual growth throughout the year in, in 2026 than what we saw in 2025. Moving on to the prenatal question, Ben, let me, let me hand it to you and, and to Brian to answer that.
Ben Wheeler (CFO)
Sure. Thanks, Sam. I, I was just going to make one comment relative to, to Prolaris or urology, Doug. As, as Sam mentioned, you know, we focused on that, that channel executing with the sales force, and that, that gives us confidence as we look at 2026. Like Sam said, we don't expect, or we didn't model out a 12% year-over-year growth going into 2026. The guide did reflect some traction relative to the, the total annual growth rate that we saw in 2025 moving into 2026, and, and we're bullish about the, the opportunity ahead as we see the performance that we saw in Q4. Now, transitioning over to prenatal, you're accurate in, in the view that volume declined in Q4.
Typically, Q4 is often a challenging volume quarter period, all else equal, not simply saying that that is the year that we had for prenatal in 2025. When you look at the seasonal or the quarterly volumes from a prenatal standpoint, oftentimes you'll see a softening in Q4. We did see softening in Q4, and as we mentioned in the prepared remarks, and then also, you know, as I briefly shared with Puneet, our expectation is that we'll see a decline in prenatal year-over-year in Q1, with recovery in Q2 and beyond. There's several things that give us that confidence. Part of it is having a focused sales force, as they focus on our prenatal bag, and Brian can speak more to that.
The, the early traction that we're seeing in conversations with GeneSight and FirstGene, excuse me, as providers will be interested and open to conversations as we work to win back share as well. I, I do want to emphasize the fact that the guide does not include a sizable benefit from FirstGene. We do believe that as we launch that product commercially, we'll have an opportunity to have conversations with docs that will give us some traction or leverage across the portfolio.
Brian Donnelly (CCO)
Hey, it's Brian. Just a couple of adds for that. As have the key to the order management issue that we have been working to resolve throughout the year, what we have seen underneath that is accounts who are not impacted by our order management issue are growing at or above market, which is a good signal for the underlying health of the base. In the same period of time, we've been focused on adding new customers. Our sales team has been really focused on restoring the accounts where we lost volume. If you go forward into this year, Sam mentioned earlier, we have our prenatal sales team that we're going to be expanding going into the second quarter, and we have the FirstGene launch.
You know, I would just, just align fully with what Ben said. You know, we do, Q1 is going to be the beginning of this year for us. We're, we're excited to get out into Q2 and into the back half of the year when we've got our, our new, our expanded team and our new product.
Operator (participant)
Thank you. Our next question comes from Andrew Cooper of Raymond James. Your line is open.
Andrew Cooper (Director of Equity Research for Life Science Tools and Services and Diagnostics and Clinical Laboratories)
Hey, everybody. Thanks for the questions. Maybe just to follow up on that, I do want to drill in a little bit more on just how many customers are less that kind of are affected by this by the change at this point? Is it a few important ones? Is it kind of more widespread? I just would love a little bit of kind of color there. What other parts of the portfolio maybe need some updates to some of your systems? At this point, how are you balancing those risks and thinking about it differently than you were, you know, before sort of this, this hiccup in prenatal?
Sam Raha (President and CEO)
Okay, maybe I take the second question first. Thank you for the questions, Andrew. Ben, if you and Brian, if there's anything you want to say with the first question. We take it incredibly seriously, Andrew, and we took the opportunity when it happened in Q2 of last year to look through every ordering that we have and to really ensure that everything was intact, that we had no issues, no friction, either in the test ordering system or in the reporting system.
What we really learned is, as part of improving execution excellence, it's about, you know, a different level of rigor and testing that we'll do before we go live with something, right? This was a self-induced error that we had, which we should know, and we did, and we've taken care of it. We have gone through all our other testing, all of our, excuse me, ordering systems, and we feel good about all of those, you know, continuing to work as they are without any issues.
Ben Wheeler (CFO)
Building on that, as Sam mentioned, you know, we had a challenge thereafter. It's to win back the customers that encountered that challenge. We see some progress there, and I'll have Brian speak to that in just a moment. I think it's important to recognize that, as we have the opportunity to go back in there and reengage in conversations, being able to speak about a new product is an opportunity that opens that conversation or opens the door that we have not necessarily had the opportunity to leverage or open over the last couple of quarters. Again, not to, to be too repetitious here, but that's one of the things that really gives us excitement about the ability to, to move forward and see year-over-year growth as we move Q2 and beyond.
Brian Donnelly (CCO)
Yeah. Hey, this is Brian. I, I don't have a lot to add to that, other than, as it relates to where we're at now. We, we have a really good handle on our current accounts. We understand their needs. They're adopting our portfolio. We feel really good about our current customers and our relationships with them, so we, we feel like we are stabilizing there.
Andrew Cooper (Director of Equity Research for Life Science Tools and Services and Diagnostics and Clinical Laboratories)
Okay, great. Then maybe if I can just sneak one more in. Just on GeneSight, you know, you talked about the 12 payers and the biomarker bills that you added in 25. Now, how should we think about the trend in ASP there for 26, knowing that, you know, you're past sort of the, the, the big headwind here that you've been facing for the last year or so?
Ben Wheeler (CFO)
Yeah. You know, we've been really pleased to see the, the traction that's come as, as we've engaged in states with biomarker bills and, and the wins that we had in 2025. You know, those wins came across the year, you know, there's going to be an annualized benefit to some of those that we didn't see in 25, but none of them in isolation are a sizable win. You know, when, when we think about 26 from an ASP standpoint, again, across the portfolio, we're expecting a, a modest headwind. As it relates to GeneSight, we just think about it as, as being stable.
Sam Raha (President and CEO)
Hey, Dan, let me just add to what you said. Sorry, Andrew, is that, you know, the good thing, well, if you will, is we have a much more balanced portfolio, if you will, of payers now. Unlike, what had happened with United, you know, even if we were to lose another payer, unless it were to be Medicare, and there's no, no sign of that, we feel that's completely stable. You know, we're, we're in a much better place than we were.
Operator (participant)
Thank you. Our next question comes from Dan Brennan of TD Cowen.
Dan Brennan (Managing Director and Senior Research Analyst)
Great, thank you. Thanks for the questions. Maybe just on hereditary cancer, can you just walk through a little bit, kind of what's assumed this year for volume growth? You had some nice growth this quarter. I think comps are a little easy. Just wondering how we might think about the volume growth in hereditary cancer going forward.
Ben Wheeler (CFO)
Yeah. Dan, when we think about 2026, we, we think about a high single-digit growth from a hereditary cancer portfolio perspective, and that's across both unaffected and affected. You know, obviously, exiting the year with the momentum that we had continues to, to add to how bullish we are about that, but that's, that's how we're thinking about it in 2026.
Dan Brennan (Managing Director and Senior Research Analyst)
Okay. Maybe just on pricing. I think you said you have a headwind on the whole portfolio. Can you just give a little bit more color on that? Like, is there a specific dynamic in 26, or just, you know, how do we think about that?
Ben Wheeler (CFO)
Yeah, Dan. I wouldn't think about it as a specific dynamic per se for the portfolio. I would just think about it, just generally as we experience price pressure in hereditary cancer, you think about the dynamics for GeneSight. Net-net, we expect the portfolio to have a very modest decline, you know, 1%-2%. You know, obviously there's individual dynamics for different screen groups out there in 25. You know, we'll continue to engage with payers and we're excited about the ASP that FirstGene can bring to the portfolio as a modest improvement for our existing prenatal portfolio. When you think about the enterprise ASP, that's how we think about the modest headwind of 1%-2%.
Dan Brennan (Managing Director and Senior Research Analyst)
Maybe just one more sneak one in. Just on MolDx and MRD, like, so do you assume you get the coverage in the back half of the year, and then you're, you have some revenue contribution from that coverage in the model? Sorry if I missed that.
Sam Raha (President and CEO)
No, Dan, we did not. We're not assuming that we would get coverage until sometime in 2027. We're assuming really no revenue from MRD in, in our 2026 numbers.
Dan Brennan (Managing Director and Senior Research Analyst)
Great. Perfect. Thanks, Sam.
Operator (participant)
Thank you. Our next question comes from Mason Carrico of Stephens. Your line is open.
Mason Carrico (VP and Equity Research Analyst)
Hey, thanks for the questions here, guys. A lot's been asked, but on FirstGene, I guess, what do you view as, as the largest practical barrier, to scaling adoption and revenue for that assay in 2027? I mean, is it clinical confidence? Is it workflow integrations, payer coverage, sales execution? I guess, which barrier do you feel the most confident, confident that you can clear early? Which do you think takes more time?
Sam Raha (President and CEO)
Yeah, thank you for the question. I'm going to let Brian, if you, you don't mind.
Brian Donnelly (CCO)
Yes, sure.
Sam Raha (President and CEO)
Yeah.
Brian Donnelly (CCO)
Yeah. Hey, thanks for the question. With regard to FirstGene, you know, for us, as you know, this is a new product, so it is really about getting, getting the product in front of our providers, both our existing base as well as new customers we're interested in doing business with.
Ben Wheeler (CFO)
It is going to be the, the traditional issue of getting folks aware of the product, ensuring they understand the product to a degree where they're willing to clinically adopt it and then pulling it through. There isn't, like, a particular issue here other than just really good execution, getting the product in front of customers and being there for them when they're ready to start using it with their patients.
Sam Raha (President and CEO)
Hey, Brian, if I can just add to that. I think that, you know, we've been pleased with the early access period that we've had so far, both in terms of the input we've received from customers that have been using it, from our own operational efficiency that we've seen and behind you, and also, though it's still relatively early from the, the reimbursement that we've gotten. All those things you mentioned, you know, we're, we're not going in blind.
We have a, a pretty good sense of it. The other thing is, you know, we, we want to have higher mar-market share, and we intend to in the coming quarters and years, but from where we are, you know, we see FirstGene, particularly this combined screen, as an opportunity to expand the market, at least for us, and to go gain new share. That, that's something that, that is really, I think, important to our future.
Mason Carrico (VP and Equity Research Analyst)
Got it. Could you talk about the progress you've made in terms of cross-selling multiple assays across customers or really just growing wallet share? Are there any metrics you can provide to highlight how maybe an increasing percentage of your customers are ordering more than one test from the Myriad portfolio, or any update there?
Sam Raha (President and CEO)
You know, we will likely share something along the lines as we get deeper into this year, but what I can say, Again, we have intentionally gone to focus sales organizations. Again, as we mentioned, for prenatal health, we are kicking that off in Q2, so that's going to be even more of a focus now with Prequel, Foresight and FirstGene that will be coming. In oncology, I can give you an example, in the urology channel, we are pleased that, along with Prolaris, there are, you know, a number of customers, increasing number of customers who are also using MyRisk to our hereditary cancer test, because that is written into the ASCO guidelines for those who are in the course of being treated for, for prostate cancer.
Fundamental, the great question to our, we differentiated, and we really believe we [inaudible]. Is our, you know, strong, established relationships in community medicine as it relates to, you know, the, what we call the cancer care continuum. There, what we are finding, we and [inaudible] relevant tests in the course of treatment. We fully expect, and the numbers, you know, are things we're going to track here between hereditary cancer, between our comprehensive genomic profiling tests, between MRD, there should be a, a growing connectivity and a benefit by being in an account serving it. Great question, and we'll, we'll look to share more of that in, in the coming quarters.
Mason Carrico (VP and Equity Research Analyst)
Got it. Thank you, guys.
Bill Bonello (Senior Research Analyst)
Thank you. Our next question comes from Bill Bonello of Craig-Hallum. Your line is open.
Hi, guys. I just want to circle back to your response to Tycho's question on the hereditary cancer ASP, then I do have a follow-up to that. I, I totally understand the price differential between affected and unaffected, but obviously, the ASP was down in, in both of those groups this quarter. Later, you made, you know, some comments about the pricing, headwinds and pressure. I guess I'm, I'm, I'm trying to understand, is that really simply payer mix difference, or are you seeing your contracted rates for, you know, MyRisk going down, from where they had been?
Ben Wheeler (CFO)
Yeah, Bill, appreciate the question. The short answer is no, we are not seeing contracted rates going down. We're not experiencing pressure in that regard as we have conversations with payers. Really, as we think about ASP, as I mentioned, Q3 is a reflection of the mix that we expected going forward. We saw that be consistent in Q4. That's the way that I would think about it into 2026. Use Q3, Q4 as the ASP baseline, recognizing that in Q1, with deductible resets, there's going to be ASP pressure across the portfolio that will then generally recover through the remaining 3 quarters of the year.
Bill Bonello (Senior Research Analyst)
Oh, okay. And when you say mix, not necessarily mix between affected and unaffected, but mix like payer mix.
Ben Wheeler (CFO)
That's correct. When you think about it, volumes coming from a particular payer versus a different payer versus patient portion.
Bill Bonello (Senior Research Analyst)
Yep. Oh, are you guys still there?
Ben Wheeler (CFO)
We're here. Yep.
Sam Raha (President and CEO)
Yeah. Can you hear us, Bill?
Bill Bonello (Senior Research Analyst)
Okay. Yeah, you've been kind of breaking up. It might. It's probably just my phone. The follow-up is, is just you talked about a change in the way that you're going to show the numbers, which sounds like it will, you know, maybe make it easier for, for all of us. I, I'm just curious if that change is reflecting any underlying change in your go-to-market strategy for the various businesses. I mean, you've talked about the focused prenatal team. Will there be changes in who is actually selling, for instance, MyRisk into the unaffected market? Will, you know, current salespeople have, you know, essentially the same bag they've had all along?
Sam Raha (President and CEO)
It's a great question, Bill. Yes, we are making changes. Again, a quick summary. You know, in October, we shared that we made a number of changes organizationally. We went away from what we used to call the business unit structure with women's health, oncology, and, and so forth. To cut to the chase, yes, now we, we have determined through our strategy focus channels, meaning now those folks that are in prenatal, that, that we're going live with this coming quarter, they're selling prenatal products. Again, that's Prequel, Foresight, and FirstGene, and they will not be carrying the unaffected, excuse me, they will not be carrying MyRisk, if you will, to serve the unaffected population.
Likewise, we have, you know, said that there can be more, we believe, more traction, by having a team that is really focused on serving breast cancer. That supported a number of marketing initiatives to drive awareness, to drive market activation, both directly what we're doing and through partners and through other channels we're driving. It is a very intentional way we build more efficiency and growth, visibility through the, the reach and frequency that we intend to, intend to, you know, execute on.
Bill Bonello (Senior Research Analyst)
Thanks. That's really helpful.
Operator (participant)
Thank you. Our next question comes from Lu Li of UBS. Your line is open.
Lu Li (Director of Healthcare Equity Research)
Great, thank you for squeezing me in. I guess my first question on the MRD, I think you mentioned that you're planning to kind of, like, disclose some of my early-stage metrics. I wonder if you guys have, like, internal targets, for like, for example, like per center utilization, like, how do you measure success, for those metrics?
Sam Raha (President and CEO)
Yeah. No, great question, Lu, Lu, appreciate it. Yeah, so, among other things, the 4 things that we will be looking at is user experience for those that are part of the alpha. When we say user experience, it's all the way from how their, you know, their perception on ordering, on the turnaround time, on the quality of the results, the reporting, how easy it is to interpret and take action from it. That's one category. Repeat orders. I think that one's pretty obvious. It's important that, you know, that we see oncologists, healthcare systems, the same ones continuing to order for multiple patients. Order volume.
You know, though we're not disclosing that, we are looking to see that we are able to achieve a certain number of volume of orders here within our alpha time period, if you will. Operational efficiency. Those are the other things that will ensure that we're able to scale and prepare to scale more. That includes, you know, our internal yield, turnaround time, our targeted COGS, and other elements. Those are the metrics that we'll be tracking.
Lu Li (Director of Healthcare Equity Research)
Got it. One question for Ben. I think the guy talking about the EBITDA margin going to be, like, near break even in Q1. I wonder, can you comment on the pacing of that and anything else that you wanted to flag, just in terms of, like, the Q1? Is it just, like, the prenatal volume headwinds or anything else that you want to flag? Thank you.
Ben Wheeler (CFO)
Sure. Yeah, we've touched base on the, that's going to be down year-over-year. Also, when we look at historical, operating expenses from Q4 to Q1, Q1, we have some outflows just because of the regular cadence of meetings and compensation adjustments and the like. The combination of deductible resets at the start of the year, the impact of prenatal year-over-year decline, and then, a modest step up in OpEx starting in Q1 and persisting through the year is what impacts the profitability in Q1. I will say, when we think about the full year, it's important to remember that when we look back across the last couple of years, H2 revenue is stronger than H1 revenue.
I just talked about the, the impact of a step up in operating expenses, that, that we will titrate, as, as we see some traction with some of our commercial initiatives. You know, we, we issued guidance on January 12th as it relates to adjusted EBITDA, and we're still very confident in that level.
Operator (participant)
Thank you. This concludes our question and answer session. I'd now like to turn it back to Matt Scalo for closing remarks.
Matt Scalo (SVP of Investor Relations)
Thanks, Dee Dee. This concludes our earnings call. A replay will be available via for one week. Thanks again, everyone, for joining us this afternoon, and have a good day.
Operator (participant)
This concludes today's conference call. Thank you for participating. You may now disconnect.