All right, good afternoon, everybody, welcome back to the 46th annual TD Cowen Healthcare Conference. I'm Kyle Boucher, an analyst on the Life Science and Diagnostic Tools team here. I'm pleased to be joined by Myriad Genetics. I have Sam Raha, President and CEO, and Ben Wheeler, CFO. Great to have you guys.
Thanks for having us, Kyle.
Thanks, Kyle.
Yes. Maybe just jumping right in. Starting with you, Sam. You know, Sam, it's been nearly a year since you took over as CEO on April 30, 2025, so not quite a year, but getting pretty close. You know, since taking over as CEO, you've gone through a comprehensive review of the portfolio. You've laid out your strategic priorities across each business unit. I guess maybe to start from a high level, can you reflect on your first 10 months in the CEO seat at Myriad? I guess, what's gone better than expected? Maybe what didn't meet your expectations, and what are your key priorities over the next 12 months?
Yeah. Thank you for the question. There's a lot built in there. You know, in terms of things that have gone well that I think, that are really going the way that I'd like, a lot of energy and enthusiasm within the company with our board, for really redefining Myriad and making it the new Myriad. Related to that, you know, I'm pleased with the work that we've done collectively, to redefine and restate our strategy. In our updated strategy, you know, the real focus and the opportunity that we see is building out in the cancer care continuum. Yes, we're a hereditary cancer company, but we have an opportunity, other high-growth applications as well.
This also means being very disciplined where, you know, as it ties to prenatal health and mental health, but I think we could do that and grow it at market and also do so in a disciplined, profitable way. Those things together with what's gone well is, I'm so pleased with the talent we're able to attract. We have a lot leaders on the new leaders on the executive leadership team, the next rank, and we've recently been recruiting for important sales roles as part of expansion and the talent that we're getting really, I think, speaks volumes to part of the value that Myriad has. You know, in terms of something that I think we could have done better on a learning opportunity for us is when in Q2 we were rolling out a new order management system for our prenatal business.
We had a number of challenges on the inside which led to, you know, delays in orders and so forth. You know, everything is under control now. We have that, but it takes some time to recover from that, so we've got to get better on that execution. In terms of priorities, right? That was the third part of your question. Listen, it's simple. We are absolutely focused of establishing an ongoing pattern of being able to do what we say we're gonna do. You know, make the quarter, make every quarter, meet and do better than that. It's also an exciting time. We're gonna launch more products in an 18-month span than we had in the previous five years.
Staying really focused on the new products, bringing them to market, having them being successful, you know, most of these around, again, the cancer care continuum. Third, I'd say the priority is to continue getting even stronger on execution excellence.
Perfect. I guess, you know, I'd like to touch on the cancer care continuum in a minute here, but maybe starting with your full 4Q results that you reported last week. You reported 4Q results a little bit ahead of the pre-announced range, ahead of JPM back in January. You also reiterated your 2026 guide for 6% growth at the midpoint or $860 million-$880 million in total revenue. 2025, I think, had a number of puts and takes, most notably the UNH GeneSight headwind the mental health business faced.
I guess, you know, with that being said, can you maybe discuss some of the headwinds you saw in 2025 across the portfolio and how the portfolio is positioned for a better year in 2026? I guess, what are your key takeaways from 2025 that informed your view on 2026?
I mean, as you mentioned, 2025 had a number of challenges, and there was a lot of good things too. Let me just talk about two of the big challenges and what we've done and how that informs 2026. As you noted, coming into the year, there was a policy decision, UnitedHealthcare, related to pharmacogenomics. We are the leader pharmacogenomic testing for mental health. That really, coming into the year, gave us a headwind of over $40 million on the revenue side and on an EBITDA basis as well. You know, I'm really pleased with the actions we took all the way to rightsize and refocus the team, if you will, on the sales and marketing side.
The work that we've done then to focus in on accounts where we believe we can really grow, where we believe the reimbursement is good, the work that we've continued to do related to biomarker legislation and laws take advantage of that. You put it all together, you know, starting with about only 2% growth in volume in the first quarter. We reported last quarter for Q4, growth of 9% in GeneSight. You know, it was a learning year. We also have a portfolio, I think, that's much more in terms of payers that's balanced, so that's a good place for that. Another big challenge coming into the year was related to NCCN guidelines for prostate cancer testing. That was in November of 2024.
You know, it created a lot of uncertainty in the market in terms of, hey, is Myriad gonna be in prostate cancer testing long run? You know, should we use it or not? Should we use Myriad's test? Again, I think a number of things that we did, Kyle, throughout the year, has left us exiting with momentum in Q4, including, you know, really engaging KOLs to work with them to help really define what is the value proposition of Myriad's test. You know, really working to do the blocking and tackling instead of marketing and sales to drive more opportunity. We added to our sales team. You put that together with a partnership that we announced with PATHOMIQ to bring an AI-enabled test. All of that, I think, you know, built up as the quarters went by.
As we look at this year to inform our guide, listen, we think, you know, first of all, GeneSight stabilized as I started there. We think we can grow that at or above market, and that's in the mid-single-digit%. We believe for hereditary cancer testing, I'm sure you'll have questions there, it's a $7 billion market. We are one of the leaders. We have an opportunity to really grow there, the high-single-digit% or more. Prenatal, as I said, we had a challenge there, but we are past it now. It's being able to return to growth in that business.
You put those together without even factoring in the NPIs really into the contribution this year, I think it gets you to, you know, our range of our guidance, which we intend to absolutely meet.
Maybe on the longer term sort of outlook, you know, you've stated a number of times that the company can sustainably grow in the high single to low double-digit range. You know, the 2026 guide reflects a bit less than that at 6%, but getting, you know, a lot closer to that range. I guess what's really the key to driving Myriad's portfolio to your long-term range? Do you think this year you could exit at sort of the low end of your long-term growth outlook? I guess how much conservatism is baked into the 2026 guide?
Yeah, another great question. I think that, let me answer a little bit out of order. If you look at our guide, and if we, you know, grew at the midpoint, which is between our guides $860 million-$880 million for this year, we exited last year at a little over $824 million. At the midpoint, we're about 6%. If you're at, you know, if we're at, $880 million, we're closer to 7%, which is the low end of high single digit, right? To, you know, to really be able to grow into that ability to grow high single, low double digit, Kyle Boucher, I think it's about, you know, three things.
One, it's about continuing to execute, get better at that in terms of, you know, new product launches, in terms of the things that we do. Number two, again, new products, that's gonna be less of a 2026 contribution. You know, between Precise MRD, which are in alpha launch mode as of yesterday, the new AI-enabled Prolaris Test, FirstGene, for prenatal, all of these things together, with the deliberate expansion activities we're doing on our sales team, I think really sets us up to grow into that high single-digit, low double-digit as we go into 2027 and beyond.
Maybe before getting onto sort of the products, I have a question for Ben, actually. You know, Ben, you've been CFO at Myriad since August, but you've been with the company for a number of years, I think over 14 years, and you've held a number of roles from assistant controller, corporate controller, CFO of operations, and you clearly have a deep history with the company. I guess, you know, can you reflect on the last 5 to 6 months in your role as CFO? How has your history with Myriad, and the myriad of roles that you've served in shape your sort of view as your philosophy as CFO?
Sure. Yeah, I've been at Myriad over 14 years and had an opportunity to lead every part of the finance organization, including revenue cycle management. In the various roles, I've also had the opportunity to work very closely with our operations folks, our commercial leaders, tech, R&D, really a chance to get deep across the organization. As I've had an opportunity to work in these different areas and partner across the organization, it definitely impacts the way that I think about driving growth and success as an organization. It impacts how I think about capital allocation and how we tie capital allocation to our strategy. I think about the importance of execution that Sam is focused on, and that's one of the things that excites me most about where we are now and when I look forward.
As we drive execution and we continue to work collaboratively across those functions, we have an opportunity to take Myriad back to what it has been before.
Got it. let's move over to some of the products here. starting with the cancer care continuum.
Mm-hmm.
This was a big focus of your earnings call last week. You know, I think you're gonna start reporting a single line item...
Mm-hmm.
For the cancer care continuum. Maybe, maybe getting into the pieces of that, starting with the hereditary cancer business, which grew, you know, low single digits in 2025. Volume was at the lower end of high single digits, around 7%, and pricing was a drag, you know, bringing that down to around 2%. I guess in the context of your long-term guide, how should we think about the outlook for your hereditary cancer business over the long term? You know, you've discussed the business being a high single-digit grower on volume in 2026. How should we think about the pricing side? I guess, what are the major factors that are driving, you know, your view on pricing over the next few years?
Let me start and then I'll hand it to you. I mean, Kyle, first I want to start by saying, you know, we are, you know, really excited and bullish about the opportunity of hereditary cancer testing, right? In terms of the market size, it's $7 billion together, growing in the high single digits. We launched an updated, expanded MyRisk panel last in Q4. We're seeing good traction with that. We have a disease-specific panel offering coming up later there. We are deploying focus channel and the unaffected opportunity. We have a number of partnerships going on. We feel really strongly that the opportunity for growth from a volume standpoint is right in front of us, and we are the rightful owners to really continue to drive the market.
Maybe Ben, you can talk about the pricing part of it.
Sure. Maybe just before I talk about pricing, I'll just segue in building on what Sam said. You know, when you think about annual growth of 6% in hereditary cancer from a volume standpoint, but Q4 volume growth of 9%, the momentum across the organization, particularly focused on hereditary cancer, was exciting and that again helps us be bullish about what we expect to do in 2026.
Hey, Ben, can I just interject one thing right there? Just so we have the facts out there, increasingly a bigger part of our hereditary cancer portfolio when you factor out, you know, things that were historic is about MyRisk, right? That's our flagship test. When you look at MyRisk in Q4, it grew collectively between unaffected and affected around 13%. That just to give you a sense of data as we come out of Q4. Sorry.
No. Thanks, Sam. When you think about hereditary cancer ASP
We talked on our Q3 earnings call about the year-over-year comp challenges. When you think about biopharma revenue. Biopharma is a very healthy ASP. Our current agreements are generally focused on HRD and MRD. We had a tail of our hereditary cancer biopharma testing that essentially came to a conclusion as we exited 2024 and into 2025. That had an impact of about 2% on hereditary cancer ASP year over year. When you think about a change in revenue estimate or out-of-period revenue, something that was not significant to the portfolio or the enterprise in 2025.
When you're looking at ASP for a particular product, there was about a 2% drag year-over-year on hereditary cancer ASP as a result of positive out-of-period that we had in 2024 that didn't recur in 2025. The remainder of that headwind was associated with a shift in mix. Again, as we spoke about on our Q3 earnings call, Q3 is a baseline to think about hereditary cancer ASP going forward. We saw stability in that in Q4, and that's how I would frame out 2026 thinking about the baseline of Q3 and Q4.
Got it. Maybe moving on to new products, MRD especially, which, you know, you launched this week in a select number of users. You know, you discussed your strategy at length during the 4Q call. Your Precise MRD assay, you know, you plan to launch in renal and colorectal later this year. You just launched in breast at a limited basis. Can you talk about the technology, the Precise MRD technology as an ultrasensitive test, which I think are getting a lot more attention now, I guess? Maybe can you talk about the differentiation that you see versus other tests on the market that are using an ultrasensitive approach?
I mean let me start there and also build into why we believe that we have an opportunity and a right that we're gonna build a meaningful MRD franchise for Myriad in the coming years. As it relates to our assay itself, absolutely. It is a ultrasensitive MRD assay that's based on tumor-informed whole genome sequencing data to start looking across 1,000-plus sites. What that gets you is resolution or sensitivity down to 1 part per million. As you might know, that's particularly important for cancers that are low shedding, including breast, prostate, ovarian, endometrial, and so forth. For us, the reason that we think we can really have a place here, Kyle, is a combination of that along with the fact that we are gonna focus on community.
Did you know, I think I had in my prepared remarks last week, 85% of oncology care in this country happens in the community. We served over 3,500 oncologists in the community in 2025. We have a leading position. We're trusted for the work that we've done over the last 3 decades. We're gonna go there, and we know what's really important in the community, along with, you know, a great test and being there, being embedded in the EMRs, is also having the combination of tests that are used together to inform the course of treatment. Again, we have, you know, the gold standard for hereditary cancer. We have the leading test for HRD. We're working through partnerships for CGP, part of therapy selection.
You put that all together, and, you know, it's gonna be about execution on a commercial side, where we're adding commercial capabilities both in sales and marketing. That's why I think that we're gonna be differentiated and have a place in MRD.
I guess on the indication front, you know, I just mentioned that, you know, going after breast first, renal, colorectal cancer later this year. Have you discussed your strategy on the different indications that you're seeking to go after over time, and maybe how long? You know, what's the roadmap to these coming online over the next few years?
What I can tell you is the following. I mean, you kind of just summarized the part you've already said. We're starting with breast, and that launch alpha has already started this week. We're pleased with that, and we'll share, you know, at least on a qualitative basis, you know, some of the key metrics we're tracking on the Q1 call. You know, we have a monitor study publication concurrent to that acceptance. We'll do the MolDX submission plan for Q3 of this year. That's for breast. As you said, colorectal and renal supported by MonSTAR study, that's for colorectal. That's with our collaborators in Japan. We already published a study in November in The Lancet journal last year, which will allow us to submit for MolDX.
We're gonna do early access at the same time when we submit for these in probably the Q4 timeframe of this year. Next year, we expect we're being conservative 6-12 months to get MolDX approval. We're gonna start ramping up in advance of that strategically to start get more sites that are using our assays. You know, reimbursement isn't expected till next year, we expect to have it for breast, colorectal, and renal next year. We will also submit for MolDX, as well as for to start early access in endometrial and ovarian next year. We have over 18 studies, Kyle, that are underway with thousands of patients that are enrolled or in the process of being enrolled. We will have more of a roadmap, additional assays or cancer types that we'll announce.
The key here, again, when you serve the community, we think that you need to have enough of a portfolio that the prevalent cancers that they can access through Myriad, and that's why we're being, you know, intentional about adding enough cancer types that we can serve their needs.
I guess is there any data that you would call out that, you know, is coming this year, I guess, that you know, specifically that you'd call out?
Again, I'll just draw your attention to maybe two or three studies. One, I already mentioned the MONITOR-Breast study. That's a study across multiple sites that's supporting our breast cancer work. Again, we expect to, you know, have the publication accepted in Q3, we will be sharing more updates on this along the way, including at ASCO and so forth. The MONSTAR study I've already mentioned, that's for pan cancer, including colorectal cancer. We also have just stepping also away from MRD, talking about FirstGene, which is our prenatal test. We have a CONNECTOR study underway there. We expect to share some results of that coming up around the midpoint of the year.
We are also doing a lot of work to support our AI-enabled Prolaris Test, so we have an improved position on in terms of guidelines.
You know, it's a great segue into the next question I wanted to ask on, you know, Prolaris with the enhanced PATHOMIQ capabilities. You announced that partnership last year to use their AI technology within your suite of oncology products. I guess, when exactly do you plan to launch the updated Prolaris Test? Does PATHOMIQ lead to a meaningful improvement in Prolaris' performance, or what's the key driver there for improvement?
Yeah. Listen, we're right on track. We plan to launch our AI enhanced Prolaris Test, again, powered by the partnership with PATHOMIQ and their PRAD AI capability. It's on track for Q2, coming up next quarter. You know what we've heard from a number of customers in the market is they would really like AI, but they also still have a lot of confidence in molecular. Ours will be the first test which brings together the power of molecular and AI. What that will do, like when you have in those instances where the patients are like borderline in terms of a doctor making a call of should I continue active surveillance versus prostatectomy or radiation, there's an improved confidence level based on the information from both tests. It is gonna improve that.
We think it's gonna be a stronger test and, again, you know, when someone starts buying Prolaris enhanced with AI, that is the test we're gonna sell.
You've called out Prolaris growing quite strong in 2025. I think it was one of the better performers in your tumor profiling segment that you've called out a number of times. Would you estimate that, you know, the improved assay with PATHOMIQ could lead to growth acceleration, or is this just an enhancement of sort of what you're already selling?
Great question. Again, just the set of facts is when we started the year, you know, we came into a little bit of a challenging situation because some counting us out, the NCCN guidelines and so forth. As I mentioned, a number of efforts including, you know, KOL engagement, clarity of our value proposition, adding salespeople, and the, you know, the anticipation for the AI test, I think has led to improved performance throughout the year, including 12% growth in Q4, right? There was some Compare issue that gave us a little bit of a soft Q4 last year that we benefited from.
We absolutely believe that we can grow in the high single digits or more over time, and yes, I think that the AI-enabled Prolaris allows us to start resuming a level of growth that we want and ultimately starting to take share.
Got it. Moving over to GeneSight, big area of focus heading into 2025, as we've discussed.
Yeah.
-already, you know, just given the UNH coverage decision late last year. But that said, you know, this year the underlying business performed, you know, pretty well, I think well ahead of analyst expectations. Can you discuss the strength you saw with the underlying GeneSight business in 2025? What really drove the strength? I guess, can you provide any update on the payer front and any coverage wins that you achieved in 2025, and do you expect any more in 2026? I know kind of a long question there.
I'll start, and I'll keep it brief. I know you still have some other questions. Starting off from a difficult set of circumstances in the year, I'm really pleased at how the team's performed. Again, the real focus on accounts where there can be growth and there can be reimbursement. Our teams on the payer market side to continue, you know, our efforts to get within policy, drive the value proposition, also leverage, you know, the state biomarker laws, all of which led to no additional losses of any payers in 2025. We added 12 payers. You know, we think that pattern that we've set allows us to continue that sort of growth in terms of volume. Maybe you could talk a little bit about ASPs and what to expect.
Yeah. When you look at GeneSight ASP isolating for the impact of UHC, we've seen growth throughout the last 6 to 8 quarters really driven by those biomarker law wins in various states, those 12 plans that added coverage to GeneSight, none of which in isolation are significant or large, but collectively give you a tailwind. The way that we think about ASP going forward is effectively, you know, we'll continue to work hard to leverage those laws and seek wins. We also anticipate potential payer friction in revenue cycle management, as that's just something that happens on an ongoing basis. We effectively view GeneSight ASP as stable when we look at 2026 and moving forward.
Got it. Maybe moving over to prenatal, just in the interest of time here. You mentioned this a little bit earlier, but you're launching your combined carrier and prenatal screening test in the second half of this year, FirstGene. You discussed how only 1 in 3 patients undergo both carrier screening and non-invasive prenatal screening during pregnancy, and FirstGene combines 2 tests into 1. I guess, can you discuss your key competitive differentiator here? How could FirstGene meaningfully impact prenatal revenue and volume? And I guess, will reimbursement for the, you know, 2-in-1 test be more or less than, you know, if the 2 tests were ordered separately?
I'll start, and then, Ben, if you can answer the reimbursement part. Hey, listen, we are energized about launching FirstGene, particularly through the input we've got through the early access phase and the CONNECTOR study we've done in the following way. Here's why we think that we have an opportunity and differentiator, right? One, when we launch FirstGene, it is gonna be something that can be done at 8-week gestational age. All the other tests, as far as I understand, are done at 10, 11, 12 weeks. Eight weeks is when a mother comes in for the other battery of blood draws and tests that happen. There's a level of convenience for both the patient, as well as the healthcare system, the provider.
Two, you know, the way our test is set up and run, at the time the report is received, it has both the NIPT, RHD, as well as the carrier screening results, rather than a reflex approach that, you know, the other two tests that are on the market that are similar does. There's a convenience, again, turnaround time, the availability of the test. Third, what we've heard from a number of folks that, you know, really as part of Myriad that they appreciate is the ability both for patients and providers when they have questions in advance of taking the test. What's this gonna mean for me? Should I? Is this the right thing? Afterwards when they get the results, to have the support of genetic counselors. We employ more genetic counselors than any company in the United States.
When you put that together, I think that gives us a reason with a great test performance to start again using that to really grow prenatal health.
Got it.
From an ASP standpoint, when you think about FirstGene, we will use existing contracts and existing codes, and effectively we think about ASP based on the data that we've received in our CONNECTOR study as being somewhere between 1 and 2 times the legacy prenatal products.
Got it. Then so maybe just on the overall sort of, the payer outlook, you know, for the portfolio, but the Biomarker bills, you'd mentioned these a couple of times throughout. Just an update on your view of the State biomarker bills. It sounds like you've had some tailwinds there over the last year or two. I guess how much more room is there across the portfolio to benefit from State biomarker bills?
You want me to start?
Sure.
Yeah. Hey, listen, I think there's actually a lot of room that's both an in-industry view as well as a Myriad view. There's a little more than, I think, 20 or 21 states that have at various levels enacted or passed biomarker laws. There's work going on with a lot of other states that are anticipated. Listen, the biomarker laws, you know, a lot of it was really supported by ACS, so there's clearly opportunity for cancer MRD tests. We're already seeing the benefit. We're really working it hard on the GeneSight side and the mental health side. I will tell you that, listen, it's not as simple as a law, just the law being in passed.
What really differentiates us, what's allowed us to capture the opportunity is the combination of the payer markets team that really then work with payers that. You know, our legal team that helps pull it through and the conversations you often have to have with, you know, the local legal folks together with administration. All of those things, I think there's a lot of tailwind to be had in the coming years for Myriad from the biomarker state laws.
Yeah. The only thing that I would add is you can appreciate the laws are not consistent state to state. Effectively you need to evaluate each state's laws and then figure out how that applies to your portfolio. As Sam mentioned, you know, our payer markets team has done a fantastic job leveraging those biomarker laws and gaining some traction with coverage wins for GeneSight. We will continue to work to leverage those laws when we think about MRD coverage, and we just continue to evaluate every time a state passes a biomarker law, we look at how it applies to the portfolio and what we can do.
Got it. Okay. Maybe moving over to sort of the P&L here. Sam, you know, you've not only talked about growth over the last year, but you've talked a lot about profitable growth.
Yeah
... and driving profitability. I guess, can you just walk through the path to sort of free cash positivity? I mean, how are you really balancing investing for growth versus, you know, driving towards being a, you know, a sustainable, profitable company?
Yeah. I'm gonna let my CFO take this.
When you look at our 2026 guide, from an adjusted EBITDA standpoint, we talked about $37 million-$49 million. I would think about that as it relates to our 2025 adjusted EBITDA for a guidepost or for a baseline. Building on that, in some of our commentary relative to the guide, we talked about adjusted operating cash flow of between $10 million and $20 million during 2026. The last piece that we layer on is you need to think about what we spend from a CapEx standpoint. Typically, we're looking at $20 million-$30 million a year across internally developed software and hard CapEx. You lay that all together, and you can look at adjusted free cash flow in 2026 of between a usage of $20 million and break even.
Got it. Maybe moving on a little bit different direction, but how important is M&A to your strategy going forward? You know, given your leading commercial channel, I guess folding in an attractive, you know, assets with good fit that leverage your channel, I mean, they could generate attractive returns. Is that something that's important to you guys going forward?
Hey, listen, I mean, our focus again primarily is the cancer care continuum, and it is important for us to continue building out and being able to serve the highest growth opportunities and a complement to what we have. Our primary focus right now, Kyle, is about partnerships, strategic partnerships that get us that. It's not that at the right time there wouldn't be an opportunity for M&A, but we're heads down executing quarter after quarter and providing that value. Partnerships can allow us to achieve what we're looking for in the near term.
Got it. All right. I guess with the last 50 seconds here, what excites you the most about the Myriad story, and what are investors missing?
Yeah. Hey, listen, I think it is, we're starting the year with momentum. You know, we have clarity on our strategy. We're focused. Again, cancer care continuum gives a huge opportunity to build on our leadership in hereditary cancer but really grow into the other places. We have a number of new products, more than we've had, in five years, that we are on deck to launch this year. I feel like the team that's come together is really strong. You know, I made a number of changes on the CEO staff at the next levels. You put that together with the rigor and discipline that we're putting into execution, I think we're set up for, you know, being able to really grow high single-digit, low double-digit while maintaining and growing profitability.
You know, it's an opportunity for us to go again from just a participant to being a market-defining company. I think we're at the beginning of that journey, and I think people just haven't realized that yet.
Anything to add, Ben?
Yeah. The last comment that I would share is relative to execution, as Sam has talked about. It's not necessarily a glamorous topic, but you can talk about execution. Implementing processes and driving accountability and making data-driven decisions is a different matter. We are not just talking about execution. We are establishing frameworks and driving accountability and using data to make decisions, and it excites me when I think about what that brings in the future.
All right. With that, we're out of time. Sam, Ben, thank you very much.