Myriad Genetics Inc (MYGN) 2025 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Myriad Genetics fourth quarter and full year 2025 earnings call. (Operator instructions) 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.

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 am 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 on the Investors section of our website along with the 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 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.

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. As we head into the new year, I am pleased with the progress we are making as the new Myriad 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 am 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 from myRisk in oncology at 14% over the year‑ago quarter, and myRisk in the unaffected market 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 Myriad myRisk Hereditary Cancer Test, and it supports our accelerated profitable growth journey ahead.

I am also pleased to call out the acceleration in Prolaris. A combination of actions over the last two quarters, including incremental investments in the commercial team focused on urologists, helped drive 12% test volume growth year over year. Fourth quarter prenatal volume declined year over year primarily stemming from Q2 order management disruptions. 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 2025, revenue was $824.5 million, and we delivered over 1.5 million test reports by serving over 55,000 health care 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 are also making great progress on our cancer care continuum strategy to maintain leadership in hereditary 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 are also sharing results from an increasing number of studies in Precise MRD with positive clinical data presented at major clinical conferences. And we are 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 are 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 support this year’s growth. But even more, these are leading indicators of key growth drivers for 2027 and beyond.

We are 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’ strong fourth quarter performance, we are on track to launch our first AI‑enhanced Prolaris prostate cancer test in Q2 that combines the power of molecular and AI analysis, and this is based on our partnership with Pathomic.

On Precise MRD, as I noted earlier, we are on track to commence commercial testing for a select set of customers next week, and I will provide additional color on the next slide. At the JPMorgan 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 and the ASCO GI 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‑generation MRD tests.

And to round out the robust 2026 pipeline, we are on track to launch our first multiple prenatal screen test, FirstGene, 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 are looking to further showcase Precise MRD’s clinical performance while continuing to build the 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 cancer care journey, 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 United States happens in the community. That is where Myriad has a strong established presence, where we serve nearly 3,500 oncologists in 2025. We have 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.

And 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 will look to provide an appropriate level of visibility into these metrics moving forward, starting with the Q1 earnings call.

While we are 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 are 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 are adding a meaningful number of sales and medical headcount ahead of multiple new product launches this year. Many of these new additions come from the advanced diagnostics sector and bring strong domain knowledge and experience in molecular profiling and cancer diagnostics, along with relationships across the oncology health care community.

In addition, we are 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.

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 earlier, 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 include 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 the strong performance of Precise MRD.

As Sam mentioned, we are 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 patient population. This early launch provides the opportunity to engage these providers and incorporate their feedback about a host of topics, including the ease of use, overall utility, and actionability of the test.

As we move ahead, we will plan to expand the number of centers in a controlled manner until full commercial launch.

Now moving to our women health business. In the fourth quarter, Women’s Health delivered revenue of $88.5 million, an increase of 2% over the prior‑year period. We are 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 trend is particularly important as it reflects EMR‑related workflow improvements, such as the September integration of our MyGene History assessment into Epic as a way to better identify patients that qualify for hereditary testing and improve the provider experience. So 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 that our ongoing engagement will 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.

Thanks, Mark. As Sam and Mark highlighted, we are 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 re‑acceleration 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 have 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 12 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 the 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 will 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 will address financial guidance. We are reaffirming our full year 2026 financial guidance, which we issued on January 12, including, the revenue range of $860 million to $880 million and adjusted gross margin range of 68% to 69%. Adjusted EBITDA guidance range of $37 million to $49 million. In order to support investor modeling for 2026 by quarter, we provided additional commentary in the earnings release, and I would like to highlight a few key points.

First quarter revenue is expected to be between $200 million and $203 million, representing 2% to 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 in the first half. We expect this pattern to repeat to a similar degree in 2026. This outlook is supported by current business trends and anticipated improvement in the prenatal portfolio and early contributions from recent commercial investments.

As a result, we expect quarterly revenue to grow sequentially from the first quarter through the remaining quarters of the year. I also want to make investors aware that beginning in the first quarter, we plan to simplify how we present and discuss our business to better align with our refreshed strategy and how we are operating the company.

Going forward, we will organize our reporting around our strategic areas of focus with the first 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 sneak peek. And lastly, we'll continue to report mental health as a distinct category.

We are making these changes because it provides clearer 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 are confident in our full year outlook and the team's execution as we enter 2026.

Now let me turn the call back to Sam.

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 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 are 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 with a needed blend of diagnostics, cancer and genomics domain knowledge combined with proven experience for delivering results.

Along with all this, we are 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?

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 are ready to begin the Q&A session. To ensure broad participation, we are asking participants to please ask only one question and one follow up. Operator, we are now ready for the Q&A portion of the call.

(Operator Instructions)

Puneet Souda, Leering Partners.

First one, maybe, Sam. Just given the momentum or the recovery that you are focused on for the full year, I was trying to understand what gives you confidence that we can continue with this sort of high single digit long‑term growth rate that you had before. And what you are projecting for the year, is that how we should think about 2027? Can we return back to that high single digit growth rate? Let me pause there, and I will come back with another follow up.

Yes, Puneet, thanks for the question. Well, first, let me start with 2026 and the drivers of our growth this year. Again, it is 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 is improvement that we are seeing across the board, both in commercial and other parts of our organization and execution, so we are getting better at that.

We are also, as we get along the year, adding headcount to go along with new products that we are launching and so forth. So based on what we have, the recovery of the prenatal business that we anticipate and that we have spoken to happening over the next several months and quarters, we feel confident being right there in our guidance range.

When you look at 2027 and beyond, as I have said recently at the JPMorgan conference in January, we believe that we have a number of levers in place. I will again point you to the catalyst slide, which talks about a number of new products. We have three major launches this year, starting with Precise MRD for breast and other indications, AI‑enabled Prolaris for prostate cancer, and FirstGene.

All of these things will be important that we are timely in our launch, but truly these become even more growth drivers for 2027 and beyond. So I would summarize the second part of your question in that we have confidence that as we exit this year and go into 2027, 2028, we will be on a path for high single digit to low double digit sustained profitable growth.

Got it. That is helpful. And then on the MRD launch, I appreciate the details you provided, but just wanted to get how you plan on holding back. Is it certain indications, given the competitiveness of the market -- competition in the market, and also the fact that currently the products are not reimbursed, but you are on a path towards that? Maybe talk about how you plan to throttle it back and then accelerate into the second half of the year and beyond.

And then on prenatal, if I could just squeeze in, how should we think about the growth rate in the first quarter? I know it is down, but is there a finer point on that and then the recovery through the rest of the year?

Yes. Let me take the MRD question, and then Ben, if you can answer the prenatal question. From an MRD standpoint, we are excited. As I said, it is next week. We are going live. We are going to start commercial testing, and it is for what we are calling our alpha phase of the launch, select number. So we are being selective, Puneet.

It is a little bit challenging in a good way that we have seen a lot of interest to have access to Precise MRD, but I believe we can do it in a balanced way. In this phase, what we are looking for is input on the user experience, all the way from ordering to the reporting, the number of repeat orders, the operational efficiency that we have, and ultimately the order volume that we have.

As we noted, our MolDX submission is planned for early H2, so you can call it Q3 for breast, and then later in 2026 for renal and colorectal cancer. So until we have submitted for MolDX, we are going to be a little more careful on the volume we take on. But we have a path. And listen, it will be something we will consider as the year goes by, are there merits to increase the volume? What do we think on the timing of MolDx.

So as we sit right now, we're pleased, particularly with the start of alpha for Precise MRD on breast next week. Ben over to you on prenatal

Thanks, Sam. So, as it relates to prenatal, Puneet, as a policy we do not 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 wide range related to our prenatal product.

We thought it was important to ensure folks understood that appropriately reflecting our expectation for recovery in 2026 is really the only major change needed to get Q1 revenue aligned with our updated revenue range of $200 million to $203 million.

Got it. Helpful. All right, thanks guys.

Subbu Nambi, Guggenheim.

At JPM, you laid out an ambitious MRD launch road map, which you reiterated today. As you think about the puts and takes in that road map, where is there the most risk or the most factors out of your control that could delay your road map? And conversely, are there things that could go faster than what you planned?

Yes, thank you, Subu, for the question. In fact, 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 Precise MRD that we run. Some of the things that are, as you are asking, out of our complete control 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 have been doing a really nice job of, is preparing the data for the submission and the publication. I think I have shared before, we have more than 15 active studies in MRD underway. The MONITOR study is the one which will inform and provide the publication for breast cancer MRD, and that is on track for us to be able to do that in Q3.

Now for the colorectal cancer submission to MolDX, that is part of the pan‑cancer study within the MONSTAR study we are doing with our collaborators in Japan. We believe that is on track for the second half, which will be the submission for colorectal.

Now in renal, the good news is that in September of last year, we already had a publication in Lancet for renal cell carcinoma. So those things, on submissions, speak to our level of confidence. We have, I think, a decent level of control. It is really about the MolDX timing. And as you know, Subu, we will walk that road together and see how that goes.

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 the Connector study in the 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?

Thank you. Thank you for the great question. So first, yes, we were very pleased with the results, both on selectivity and sensitivity, from about 500 samples that we noted in the press release last week.

Until the data is fully there from a broader set of individuals enrolled in Connector, we cannot conclusively say, but we see no reason to believe that the data should not be as robust and compelling in terms of performance for FirstGene.

Perfect. Thank you so much guys.

Tycho Peterson, Jefferies.

A couple on margins. So if we look at HCT volumes in oncology, you grew 9%. Revenue, obviously, only increased 3%. Maybe talk about what specific ASP or payer mix dynamics are driving this gap, and how do we think about this dynamic in 2026 as you launch disease‑specific panels?

So Tycho, this is Ben. Thanks for the question. As we talk about ASP in Q3, we talked about that kind of 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 myRisk more broadly across our sales channels, we have talked about this before, where we have about a 10% lighter ASP in the unaffected channel relative to the affected channel. And we saw that headwind across the portfolio, from 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 Q3 with the new baseline moving forward.

And then another part is just the shift in different payer mix from one payer group to another group or something along those lines.

Okay. And then on Precise, I appreciate 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 driver overall. But just talk a little bit about how you're thinking about hiring for the various indications?

Yes, sure. Maybe I'll start and then I'll allow Brian Donnelly, who is 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 training the existing team, making sure we're hiring people with the right profile, moving understanding of molecular. And beyond just the sales team, it's also our medical folks, and a lot of that is already happening. But Brian, please?

Yes. Thanks, Sam. This is Brian. So 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. So 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.

Yes. And Tycho, I'll just add to that. I mentioned earlier in my prepared remarks that we're spending over $35 million over the next couple of years, and a very big part of that is to augment our sales team. And those additions are underway as we speak. In fact, at our commercial meeting kickoff just a couple of months ago, there were 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.

Okay. That's helpful. And then maybe just along those lines. And lastly, just on the alpha launch, can you just provide any more color? You talked a little bit about how you're thinking about the number of tests you need to run, but customer profiles you're going to target?

Sorry, I didn't know if you got cut off. But did you just say, can I provide any more color? Is that what you --

Yes, on the alpha launch. I mean, you talked about a number of tests you may target, but --

Ladies and gentlemen, please remain on the line. Your conference will resume shortly. (technical difficulty)

Yes. Apologies, Tycho. I got cut off. So I think what I was answering your question about alpha is, 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. So we're looking forward starting next week to activate fully, start receiving samples, and can't share enough the excitement that we have to start.

Doug Schenkel, Wolfe.

My first one is on Prolaris, where ostensibly you picked up some momentum into year end. As you noted in your prepared remarks, reason volume 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 is my first question.

On an unrelated topic, my other question is prenatal momentum into year end. Units were actually down, I think, 5,000 or so sequentially in the fourth quarter. I just want to see if there were any remaining order management dynamics? And if so, how is that contemplated into 2026 guidance? And beyond that, 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.

Yes. Thank you, Doug, for the questions. Let me start with the question on Prolaris, and then I will hand it off to the combination of Ben and Brian to talk about prenatal. Listen, there have been a number of activities that we have been working on over the last few quarters related to Prolaris. It includes the engagement we have had with KOLs.

It includes the various programs we have been driving. It includes the expansion of our sales team into serving more urologists. So all of those things are things that we think will endure.

Now, yes, did we potentially get a little bit of a compare benefit in Q4? That is possible. But as we look into 2027, we expect maybe not the 12% growth that we had in the quarter but much stronger actual growth throughout the year in 2026 than what we saw in 2025. So moving on to the prenatal question, let me hand it to you, Ben and Brian, to answer that.

Thanks, Sam. And I will just make one comment relative to Prolaris urology, Doug. As Sam mentioned, we focused on that channel executing with the sales force, and that gives us confidence as we look at 2026. So, like Sam said, we do not expect or we did not model out a 12% year‑over‑year growth going into 2026. The guide did reflect some traction related to the total annual growth rate we saw in 2025 moving into 2026, and we are bullish about the opportunity ahead as we see the performance that we saw in Q4.

Now transitioning over to prenatal, you are accurate 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 reason that we have for prenatal in 2025, but when you look at seasonal or quarterly volumes from a prenatal standpoint, often you will see a softening in Q4.

We did see softening in Q4. And as we mentioned in the prepared remarks, and also as I briefly shared with Puneet, our expectation is that we will see a decline in prenatal year over year, with recovery in Q2 and beyond.

There are 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 early traction that we are seeing in conversations with providers on GeneSight -- FirstGene, as providers will be interested in open conversations as we work to win back share as well.

So I do want to emphasize that the guide does not include sizable benefit from FirstGene, but we do believe that as we launch that product commercially, we will have enough to have conversations with physicians that will give us some traction or leverage across the portfolio.

It is Brian. Just a couple of adds to that. So to have the order management issue that we have been working to resolve throughout the year, what we have seen underneath that is accounts who were not impacted by our order management issue were growing at or above market, which is a good signal for the underlying health of the base.

In the same period of time, we have been focused on adding new customers. Our sales team has been really focused on restoring the accounts where we lost volume. And if you go forward into this year, as Sam mentioned earlier, we have our prenatal sales team that we are going to be expanding going into the second quarter, and we have the FirstGene launch.

So I would just align fully with what Ben said. Q1 is going to be the beginning of this year for us. We are excited to get out into Q2 and the back half of the year when we have our expanded team and our new product.

Andrew Cooper, Raymond James.

Maybe just a follow up on that. I do want to drill in a little bit more on just how many customers are left 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.

And then what other parts of the portfolio maybe need some updates to some of your systems? And at this point, how are you balancing those risks and thinking about it differently than you were before sort of the tick up in prenatal?

Okay. Maybe I will take the second question first. Thank you for the questions, Andrew. And then Ben and Brian, if there is anything you want to say for the first question, please jump in.

We take it incredibly seriously, Andrew, and we took the opportunity when it happened in Q2 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.

And what we really learned is, as part of improving execution excellence, it is about a different level of rigor and testing that we will do before we go live with something. Right? This was the off‑induced error that we had, which we should not have had, and we did, and we have taken care of it.

But we have gone through all our other testing, all of our ordering systems, and we feel good about all of those continuing to work as they are without any issues.

So building on that, as Sam mentioned, as we (technical difficulty) win back customers that win back the customers that encounter that challenge, we see some progress there. And I'll have Brian speak to that in just a moment.

But 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 to open that conversation or open the door that we have not necessarily had the opportunity to leverage or open over the last couple of quarters. And so again, not to be too repetitious here, but that is one of the things that really gives us excitement about the ability to move forward and see year‑over‑year growth as we move through Q2 and beyond.

Yes. This is Brian. I don’t have a lot to add to that other than, as it relates to where we are at now, we have a really good handle on our current accounts. We understand their needs. They are adopting our portfolio. We feel really good about our current customers and our relationships with them. So we feel like we are stabilizing there.

Okay. Great. And then maybe if I can sneak one more in. Just on GeneSight. You talked about the payers and the biomarker bills that you added in 2025. How should we think about the trend in ASP there for 2026, knowing that you are past the big headwind you have been facing for the last year or so?

Yes. So we have been really pleased to see the traction that has come as we have engaged in the states with biomarker bills, and the wins that we had in 2025. Those wins came across the year. And so there is going to be an annualized benefit to some of those that we did not see in 2025, but none of them in isolation are a sizable win.

And so when we think about 2026 from an ASP standpoint, again, across the portfolio, we are expecting a modest headwind. As it relates to GeneSight, we think about it as being stable.

Ben, let me just add to what you said. Sorry, Andrew, is that -- 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, even if we were to lose another payer unless there were to be in Medicare, and there's no sign of that. We feel that's completely stable. We're in a much better point than we were --

Dan Brennan, TD Cowan.

Great. Maybe just on hereditary cancer, can you just walk through a little bit kind of what is assumed this year for volume growth. You had some nice growth this quarter. I think comp is a little easy. Just wondering how we might think about the volume growth in hereditary cancer going forward.

Yes. So, Dan, when we think about 2026, we think about a high single digit growth from the cancer portfolio perspective, and that is across both unaffected and affected. Obviously, exiting the year with the momentum that we had continues to add to how bullish we are about that, but that is how we are thinking about it.

Okay. Maybe just on pricing. I think you said you had a headwind on the whole portfolio. Can you just give a little bit more color on that? Like, is there a specific dynamic in 2026, or just how do we think about that?

Yes, Dan. I would not think about it as a specific dynamic per se for the portfolio. I would just think about it 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, 1% to 2%. And so obviously, there are individual dynamics for different (technical difficulty) screens out there in 2025.

[We will continue to engage with payers, and we are excited] about the ASP that FirstGene can bring to the portfolio as a modest improvement for our existing prenatal portfolio. But just generally, when you think about the enterprise ASP, that's how we think about the modest headwind of 1% to 2%.

And maybe just one more sneak one in. Just on MolDX and MRD, like do you assume you get the coverage in the back half of the year, and then you have some revenue contribution from that coverage in the model? Sorry if I missed that.

No, Dan, we do not. We are not assuming that we would get coverage until sometime in 2027. So we are assuming really no revenue from MRD in our 2026 numbers.

Great perfect thanks man.

Mason Carrico, Stephens.

A lot has been asked. But on FirstGene, I guess, what do you view 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? Which barrier do you feel the most confident you can clear early, and which do you think takes more time?

Yeah. Thank you for the question. I will let Brian take that.

Yes, sure. Thanks for the question. So with regard to FirstGene, for us, as you know, this is a new product. So it is really about getting the product in front of our providers, both our existing base as well as new customers we are interested in doing this with the product.

And so it is going to be the traditional issue of getting folks aware of the product, ensuring they understand the product to a degree where they are willing to clinically adopt it, and then pulling it through. There is not a particular issue here other than just really good execution, getting the product in front of customers, and being there for them when they are ready to start using it with their patients.

Brian, if I can just add to that. I think we are pleased with the early access period that we have had so far, both in terms of the feedback we received from providers using it, from our own operational efficiency that we have seen in a very high yield, and also, though it is still relatively early, from the reimbursement that we have gotten. So all those things you mentioned, we are not going in blind. We have a pretty good sense of it.

The other thing is, we want to have higher market share, and we intend to in the coming quarters and years. But from where we are, we see FirstGene, particularly this combined screen, as an opportunity to expand the market at least for us and to go gain new share. And that is something that is really, I think, important to our future.

Got it. And then could you talk about the progress you have 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?

We will likely share something along those lines as we get deeper into this year. But what I can say is we have intentionally gone to focused sales organizations. Again, as we mentioned for prenatal health, we are kicking that off in Q2. So that is 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.

On the urology channel, we are pleased that along with Prolaris, there are a number of customers, an increasing number of customers, who are also using myRisk, our hereditary cancer test, because that is written into the ASCO guidance for those who are in the course of being treated for prostate cancer.

So fundamentally, it is a great question. To offer differentiated value, we really believe we are uniquely positioned based on our strong established relationships in community medicine as it relates to what we call the cancer care continuum. Because there, what we are finding (technical difficulty) relevant test in the course of treatment, we fully expect, and the numbers are things we are going to track here, between hereditary cancer, between our comprehensive genomic profiling tests, between MRD, there should be a growing connectivity and benefit by being in an account serving it.

So, great question, and we will look to share more of that in the coming quarters.

Got it. Thank you guys.

Bill Bonello, Craig Hallam.

I just want to circle back to your response to Tycho’s question on the hereditary cancer ASP, and then I do have a follow up. So I totally understand the price differential between affected and unaffected. But obviously, the ASP was down in both of those groups this quarter.

And later, you made some comments about the pricing headwinds and pressure. I am trying to understand, is that really simply payer mix difference, or are you seeing your contracted rates for myRisk going down from where they had been?

Yes, Bill, I appreciate the question. The short answer is no, we are not seeing contracted rates going down. We are not experiencing pressure in that regard as we have conversations with payers. Really, as we think about ASP, as I mentioned, it is a reflection of the mix that we expected going forward. We saw that be consistent in Q4, and that is the way I would think about it into 2026. Use Q3 and Q4 as the ASP baseline, recognizing that in Q1, with deductible resets, there is going to be ASP pressure across the portfolio, which will then generally recover through the remaining three quarters of the year.

Okay. And when you say mix, not necessarily mix between affected and unaffected, but mix like payer mix?

That's correct. When you think about volumes coming from a particular payer versus a different payer versus patient portion.

Yeah oh, are you guys still there?

We're here, yes.

Yeah. Can you hear us?

Yes, you have been kind of breaking up. It is probably just my phone.

So the follow up is, you talked about a change in the way that you are going to show the numbers, which sounds like it will maybe make it easier for all of us. I am just curious if that change is reflecting any underlying change in your go‑to‑market strategy for the various businesses.

I mean, you talked about the focused prenatal team. Will there be changes in who is actually selling, for instance, myRisk into the unaffected market, or will current salespeople have essentially the same bag all along?

It is a great question, Bill. Yes, we are making changes. Let me give a quick summary. In October, we shared that we made a number of changes organizationally. We moved away from what we used to call the business unit structure with Women’s Health, Oncology and so forth.

To cut to the chase, yes. Now we have determined through our strategy focused channels. Meaning, now those folks that are in prenatal that we are going live with this coming quarter, they are selling prenatal products. Again, that is Prequel, Foresight and FirstGene, and they will not be carrying the unaffected -- excuse me, they will not be carrying myRisk to serve the unaffected population.

Likewise, we have said that we believe there can be more traction by having a team that is really focused on serving or enabling hereditary cancer and comprehensive genomic profiling through a number of marketing initiatives to drive awareness, drive market activation both directly and through partners. So it is a very intentional way that we are driving more efficiency and growth ability through the reach and frequency that we intend to execute on.

Thanks, that's really helpful.

Lu Li, UBS.

Great. I guess my first question, I think you mentioned that you are planning to kind of disclose some early‑stage metrics. I wonder if you guys have internal targets for, for example, percent utilization or how you measure success for those metrics?

Yes. No, great question, Lu. Appreciate it. Yes. So, among other things, the four things that we will be looking at are user experience for those that are part of the alpha. And when we say user experience, it is all the way from 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. So that is one category.

Repeat orders. I think that one is pretty obvious. It is important that we see oncologists, health care systems, the same ones, continuing to order for multiple patients. And order volume, though we are not disclosing that, we are looking to see that we are able to achieve a certain volume of orders here within our alpha time period, if you will.

And then operational efficiency. Those are the other things that will ensure that we are able to scale and prepare to scale, and that includes our internal yield, turnaround time, our targeted COGS and other numbers. So those are the metrics that we will be tracking.

Got it. One question for Ben. I think the guide is talking about the EBITDA margin going to be near breakeven in Q1. I am wondering, can you comment on the pacing of that? And anything else you want to flag just in terms of Q1? Is it just the prenatal volume headwinds, or anything else you want to flag? Thank you.

Sure. So, yes, we have touched base on the expectation that it is 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. And so 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.

Now, I will say, when we think about the full year, it is important to remember that if we look back across the last couple of years, H2 is stronger than H1 for revenue. I just talked about the impact of a step up in operating expenses that we will titrate as we see some traction with some of our commercial initiatives. But we issued guidance on January 12 as it relates to adjusted EBITDA, and we are still very confident in that level.

Thank you. This concludes our question-and-answer session. I'd now like to turn it back to Matt Scalo for closing remarks.

Thanks, TD. This concludes our earnings call. A replay will be available to week. Thanks again, everyone, for joining us this afternoon, and have a good day

This concludes today's conference call. Thank you for participating and you may now disconnect.