Are we on?
All right. Okay, welcome everyone. Good afternoon. I'm Puneet Souda. I cover Life Science Tools and Diagnostics here at Leerink Partners, and it's my pleasure to be hosting the Myriad team here. Joining me is CEO, Sam Raha and CFO, Ben Wheeler. Thanks, and great to have you guys over here in Miami.
Thank you for having us, Puneet.
Yeah.
Thank you.
Okay. Maybe, you know, I was gonna kick off with Management Philosophy, but obviously, I mean, I saw this morning that Sam, you purchased 40,000 shares maybe, and one of your Board Members had also purchased shares, I believe, last week. Correct me if I'm wrong, but.
That's right.
Maybe touch on that briefly. Then, you know, maybe also touch on, you know, you have been here one year as a CEO, you know, what would you say is, you know, sort of the number one most important learning as at Myriad in this time? Maybe just on the-
Yeah
Today's action first and then.
Yeah
on the learnings.
Well, listen, I mean, there's so much to be energized about for Myriad.
Mm-hmm
Coming into this year, I think this is really a year of inflection for us in many ways.
Mm-hmm.
Personally for me, it was really finding a time where I felt like I wasn't conflicted with the things that I know and feeling clear to do that. I've been itching to get in because, man, you know, I really believe where we're going. This was the Opportune time. I felt like I was cleared and, you know, our Chairperson, Louise Phanstiel, also purchased some shares on the Open Market last week.
Mm-hmm
You know, that speaks to the opportunity and our personal conviction. You know, in terms of your question of, you know, big learnings in the first year in the role, I think I'd answer it this way. By spending extensive time with a number of our customers, be it Oncologists, Surgeons, Healthcare Providers in other parts of the organization, it has been clear to me just the level of trust that our customers have in Myriad. I think it's based on, you know, the quality of our products, which are very consistent, very market leading. It's based on the science that backs up that quality in our tests.
Mm-hmm.
It's our team and the support that they're known for. Along with that, the learning has been that the customers, along with our teams, have been waiting for something new and something different from Myriad. Myriad in so many ways, I think, had been stagnating and this updated strategy that we have now articulated, which is really to focus in Cancer Care Continuum. building on the strength that we have in Hereditary Cancer, that remains a very important cornerstone for us. Really getting into these high growth applications, which are so core to how cancer is managed today, including, for example, I know we'll talk about it later, MRD that we've started in our Alpha Launch, Alpha Phase last week.
All of these things I think has been a learning for me, as well as it's been such a pleasant thing to see that the level of interest to be a part of the Myriad team, be it my Leadership Team, the number of new folks that we have, and people that we have. We're really adding to our MRD and Molecular Team. The folks that we have from all the great places that you'd expect, including the former company that was here, having one of their Senior Leaders now as part of our Sales Team. I think this gives us further conviction and it's been a great humbling learning of the potential that remains within the company.
Got it. Ben, maybe if you could add to that and correct me if I'm wrong, but half a year tenure at the company, what's been, you know, your experience?
Yeah, happy to share. I’ve been at Myriad over 14 years in various roles.
Oh, in the role. Sorry, yeah.
Puneet, you're exactly right. It's been a little over six months in the seat as Sam's partner as CFO. First I'll mention I've had the opportunity to work closely with Sam since he joined the organization. When he joined as Chief Operating Officer, one of my responsibilities was to be the CFO to the Chief Operating Officer. I had a chance to work really closely with Sam, leading up to his transition to CEO and really enjoyed the opportunity to partner with him.
One of the things that excites me about where we are at and what we've been focused on the last six months and are really key to drive success going forward is, you know, you've heard Sam talk about Execution Excellence, and it's one thing to talk about execution. It's another thing to build processes and to staff with people who have been disciplined and have had experience building processes and then driving actual execution. One thing that I appreciated working with Sam since he entered the organization is to drive a Culture, including building processes and establishing people that can help execute at a higher level, and that's what we're focused on doing.
Great. Maybe if I could touch on the, you know, guidance, your guidance of $870 million at the midpoint assumes some mid-single-digit sequential growth every quarter after 1Q to get to that sort of midpoint. Maybe just,
Yeah
Given the number of changes that you have done and as well as, I mean, and the recovery you're seeing in the marketplace with different products, sort of maybe just walk us through what gives you confidence that you can, you know, achieve this growth in 2026, because that's been a number one question for Myriad. Can they, you know, hit the guidance and, you know
Yeah
Potentially exceeded. Yeah.
Absolutely. Let me start here, and then Ben, please, you can add in. Yeah, I want to start with what you said right at your end. You know, when I think about the three priorities for the year, Number 1, it is to consistently do what we say we're going to do.
Mm-hmm.
It starts both with our F inancials, being able to, achieve those targets. It's also launching our products on time where we haven't traditionally had a great track record. Then again, all of this is instilling a Culture of Execution Excellence. Specifically on the Guidance, your question. One thing, just historically, the H2 of the year has had a higher proportion, slightly higher proportion of the overall Annual Revenue than the H1, so that's historic. Is it specific to this year? Listen, we Hereditary Cancer, I'll start there. We launched an updated, expanded Hereditary Cancer Panel in Q4 of last year.
That combined with upcoming launch of what we're calling Disease-Specific Panels for Hereditary Cancer, along with the fact that we, starting in April, which is just next month, we are taking what used to be our traditional Women's Health Channel, and we are actually splitting that. We have, you know, determined through pilots and other things that we've done that we believe we can have more success in the unaffected, you know, those that have familial reason for cancer but are not affected yet.
Mm-hmm
to reach more of them and the docs by having a dedicated channel to that.
Mm-hmm
A dedicated set of folks to Prenatal. All of these things, along with the other initiatives and marketing for Hereditary Cancer, gives us an opportunity to sequentially grow, and along the way that would be at the midpoint or better of our guidance. Another, you know, important thing is GeneSight. GeneSight, we are counting on that to grow mid-single-digit %. We've, you know, had, after a very difficult start to the year, we can talk about that. Last year, that is, 2025, we've really found a way to stabilize that business mid-single-digit %. I think we have goodness from Biomarker Bills and other things, and that will continue to grow the goodness, including the 12 payers we added last year.
Some of that, by the time the sequential timing of when we get the full benefit, you know, we'll have that this year. Prenatal is an important opportunity for us to return to growth next quarter, and then FirstGene launches in Q3. All of these things and the sequence of timing, they build on each other, which gives us a chance really to grow.
Mm-hmm
throughout the year. Ben, what would you add to that?
Yeah. I would just remind folks on our Q3 earnings call, we talked about the reorganization across the organization really to drive a Functional business as opposed to a Business Unit Structure. In doing that, we free up, you know, $35 million investment over multiple years. Part of the primary driver of that is to drive Efficiency and Effectiveness in our Sales Teams. Sam touched on the bifurcation of our women's Health Sales Team to help drive focus. We continue to drive capability through tools and targeting in order to get more efficient with our sales folks as well. We will continue to build on that work that started at the end of last year through the quarters this year, and we expect that to continue to help growth.
Then the last thing I'll mention is, you know, as folks recall, we saw growth of, you know, 6% from an annual perspective when you think about volumes for Hereditary Cancer and also for GeneSight. In Q4, we saw growth at 9%, exiting the year with momentum again, just as a proof point to some of that good work that we were doing at the end of last year to drive greater efficiency in our sales folks.
Maybe I'll continue with GeneSight. You know, obviously we're you know the challenge was UnitedHealth non-coverage impact. Since then, you have addressed a number of things. Maybe just give us a view into what are additional vectors that you want to push on this year in terms of the overall growth for GeneSight.
Yeah. I really like the way you asked the question because it allows me to just be incredibly explicit of the following. Our intention, again, our primary focus, resourcing energy, attention Cancer Care Continuum. we are being, in practice, very deliberate to live up to that strategy, saying then how do we within a defined set of resources, energy, and budget drive to at or above market for Prenatal Health and Mental Health, right? Not a distraction. Our biggest priority is Cancer Care. That being said, I am pleased with the work that we did last year, starting from a very difficult place where, you know, again, to revisit, we entered with January 1 with UnitedHealthcare no longer covering, right? Pharmacogenomic testing, we're number one in that market.
The actions we took in terms of, you know, simplifying the organization, eliminating cost, focusing in on really the opportunities where we believe that we'd have a higher chance of reimbursement, higher chance of growth, the actions we've done to make it easier digitally to learn about our tests and the ordering that you could do all of these things, along with the very extensive efforts between our Government Affairs Team and our Payer Markets Team or Market Access Team, resulted last year actually losing not a single payer, but adding 12 payers for GeneSight. You put that together with the Biomarker State Legislation. There's 21 states now working hard to, you know, the fruits of that collective effort. All of these things have led to our sequentially getting better and better. Now, last quarter, we grew 9% in volume.
I'm not counting on that every quarter here, but all of those things I think have given us a level of stability and opportunity to grow further this year from that.
Just on that point, maybe Ben can address this in terms of ASP. You know, on the GeneSight was a bit volatile in 2025. Maybe just walk us through. Obviously, you know, Sam talked about number of pairs that were added. How do you expect ASP to be, you know, the cadence to be throughout 2026?
Yeah. You know, Sam touched on the drivers, both the Headwinds and Tailwinds for GeneSight ASP in 2025.
Yeah.
You know, our expectation is that we'll see stability in GeneSight.
Yeah
ASP in 2026, recognizing that when I say stability, I'm thinking about that from a year-over-year standpoint. I mention that only because with annual deductible resets at the start of the year, Q1 ASP generally will see a dip compared to Q4, and that's across the portfolio, GeneSight included. You know, when we think about 2026 versus 2025, we expect stability from an average rate standpoint.
Mm-hmm.
We will see a dip in Q1 with gradual improvement during the rest of the year.
There's no reason to see why, I mean, given the Sales Force , maybe Sam, if you can talk about like, given the Sales Force and that you have currently now, some of it is optimized, the volume growth for GeneSight, is it fair to say that should? Yeah, I think it was close to about 6% in 2025, correct me if I'm wrong, but then, you know, how are you thinking about it this year?
Yeah. I mean, listen, what's built into our model going forward is to be able to grow, you know, at or above market. It's a little harder to grow above market when we are.
Yeah
The vast majority of that market, but we think the market is growing in the mid-single-digit range.
Okay.
that is, you know, our expectation.
Any updates on the engagement back with United, and any, you know, datasets that you could potentially present there? You've noted that, you know, they're not reinstating coverage for 2026, but wondering if you have any chance for 2027.
You know, in our model, we have absolutely no expectation of UnitedHealth ever coming back. If it happened, it would be something, a pleasant surprise for us. We put in a lot of effort, you know, a lot of new data sets, a lot of engagement and collaboration to help share and answer questions, and unfortunately, it didn't end where we'd want it to or any sort of real consideration. I think they have a lot of other priorities. The good news is we have so much goodness elsewhere. That's where our focus is.
Mm-hmm
You know, as it relates to GeneSight, I think I said it at a January conference, even at this level of growth that we have now.
Mm-hmm
While managing ASPs, as long as that holds relatively stable as Ben was just talking to, together with our planned COGS improvements, that business is gonna be break even to profitable within the next two-three years.
Got it. Maybe switch gears to the hereditary piece. You talked about unaffected business, but there were some, you know, challenges there on the EMR integration. Maybe just remind us, you know, that I believe that is behind, but maybe just remind us if there are any lingering impact from that, from the customer point of view. Overall, you know, how are you thinking about just pushing into more of that unaffected volume and you know, driving that business?
Yeah. Great question. No, we don't expect any lingering impact from the challenges we had. Again, just as a reminder, coming into 2025 in the Q1, we were already starting to implement a number of, you know, awareness programs for the unaffected market. We then realized that some of the things to fully enable that, including having what we call MyGeneHistory, which is the intake form upfront to qualify someone to be eligible for reimbursement. That thing wasn't set up within the EMR system. That was what it was, and there were some other workflow issues related to the sample collection kits being sent at the right time. All of those things have been resolved. We're actually in Epic. MyGeneHistory is there, now enabled within that.
We already saw the improvements in unaffected throughout quarter- by- quarter, including, you know, Q4. It was double-digit growth for us in unaffected. Actually, it was double-digit, both unaffected and affected. The things that we have going for us to particularly further activate includes, you know, further programs to enable existing and new Healthcare Providers and Systems to further identify and bring forward patients that could benefit from testing. We're working with a number of partners, including jscreen. Towards the end of last year, we announced a partnership with Clairity, an AI-enabled company together with MagView. These are other ways that imaging centers where MyRisk becomes part of the care. We're, you know, also gonna do other things to better activate and drive knowledge within the broader population.
We'd worked with Hannah Storm and others, public figures. We have Professional Golfers that we've used in the past. There's other ways, I think, to drive the awareness. What's very important for me is to do it in a way that we can see a benefit within a time horizon, not over years, but within at least quarters. These are the things, particularly Brian Donnelly.
Mm-hmm
Who's joined us as our Chief Commercial Officer. Brian worked for years as a Chief Commercial Officer at Ancestry, so he brings a lot of real relevant knowledge of how to engage and help activate part of that opportunity for us.
Yeah. Puni, maybe if I could just mention one thing, just to circle back to something that Sam said earlier. As we think about our Women's Health Sales Force and Bifurcating that group, we're gonna have sales folks-
Great point.
that are entirely focused on driving unaffected Hereditary Cancer volume.
Maybe shifting gears to the ASP side, you know, maybe walk us through the pushes and pulls there that are driving, you know, ASPs down. I mean, you did a good job of addressing that in fiscal 2024 with some of the Revenue Cycle Investments, but now I believe the Consensus is expecting ASPs to be down. Maybe just walk us through what are your considerations on the ASP.
Sure. We saw a 3% decline in ASP at the portfolio level in 2025. Sam's touched on the primary driver of that with the UnitedHealthcare policy decision change. Additionally, something that we don't bring up as it is not Material to Revenue, but when you think about the impact to ASP, we had about $20 million of change in estimate revenue or out-of-period revenue that benefited 2024 that didn't recur in 2025. Again, $20 million on a base of $825 million, not significant. When you're looking at ASPs as a percentage year-over-year, we had about a 1.5% headwind to ASP as a result of the non-recurrence of that.
Again, not a reflection of a challenge, just a reflection of optimizing rev cycle efforts that we got a benefit from in 2024. The combination of UnitedHealthcare and the non-recurrence of that change in estimate of revenue both headwinds to 2025, partially offset by wins that we had in Biomarker Law states relative to GeneSight coverage.
Mm-hmm.
We also saw traction with some payers that have Adopted Medical Policies relative to expanded carrier screening in 2025. We will continue to focus on those things, Biomarker Laws and expanding coverage from an expanded carrier screening perspective in 2026. We also anticipate that there's going to be friction with payers through rev cycle process. Ultimately, as we've talked about earlier this year, the expectation is that we'll see a modest decline in ASP, 0%-2% during the year as a result of mix shift in your products, right? As you have a higher proportion of revenue generated by products that are growing at a rate that's lower than the average ASP sometimes.
Additionally, the last thing that I'll share in 2025, the impact of ASP that we don't expect to recur in 2026 was specific to Hereditary Cancer. Our Biopharma Revenue has very healthy ASP. As you would expect, our contracts today are generally focused on HRD and MRD. We had contracts that were associated with Hereditary Cancer, but the tail of those contracts essentially ran out in early 2025.
I see.
That was an impact of about 2% from an ASP standpoint year-over-year in comparison.
Got it. Okay. That's helpful. Maybe, Sam, in terms of Pipeline products for the Hereditary franchise, I think you've talked about MyRisk, disease-specific panels. Anything else that you would want to highlight for that?
I mean, listen, for Hereditary Cancer, we believe with the launch that we had, again, last quarter, Q4, that we have the most current 63 genes that are the most recommended by NCCN and ASCO, and we can see that resonating in the market. The disease-specific panels will really allow Doctors who are specialized, say, in Colorectal Cancer or Breast, whatever it may be, to more conveniently get exactly the information they want without anything that would distract them. Beyond that, there's nothing immediately on the horizon. We think that's going to really serve.
Yeah.
As we're already talking about, it's the marketing program, it's the Sales Force , you know, restructuring, refocusing these things, that will really help us drive growth. Hey, along with that, it's great that ASCO or NCCN continues expanding guidelines.
Yeah.
Unfortunately, there's more patients that are being diagnosed with cancer, but that is also market opportunity for us.
Great. Given the time, let me move to Prenatal. Your volume, I believe, was 4.5%. ASP grew, you know, 10%. Maybe just talk to us about the Order Management issue that you had. You experienced that, you know, but how much of a headwind was it to performance over the last several quarters? Sort of, you know, how should we think about 2026? Any further impacts from that, or is that, like, all behind and addressed?
Yeah, I'll start here, and then, Ben, you can jump in here too. I mean, yes. We had an unfortunate issue when we were rolling out a New Order Management System Q2 of last year. Completely resolved. It was resolved within a quarter, but the lingering effect is we had some customers, you know, most large Healthcare Systems will work with one or multiple of us just to have that ability to kind of toggle. Some of the customers that we lost, it's going to take some time to get them back.
Mm-hmm.
The good news is, when we look at the data and you cut it by over the last nine months, customers that are net new-
Mm-hmm.
To Myriad and Prenatal, and you look at their growth rate, it's at or above market. It's growing. That's a good, healthy indicator. We're starting to get back, you know, or grow the volume of some of the customers we lost. Now it's going to be a matter of also, I think, a big benefit of FirstGene, which is going to be our upcoming launch of the combined screen, right? NIPT together with carrier screening. I think these things give us confidence that it's going to take some time. Q1 is still a tough quarter for us because it was a tough compare in the sense that it was maybe one of the strongest quarters we ever had in Prenatal right before we kind of fell off the shelf there. You know, we want to manage Q1 expectations.
I think we should be returning to growth in Q2, and fundamentally, we think the business is intact, but it has been a long, you know, crawl out from a situation, unfortunately, that we had created.
Yeah, just building on what Sam said, when you think about 2024 Q4, we had some product enhancements from a Non-Invasive Prenatal Screen standpoint. We rolled out eight-week Gestational Age Testing. We also expanded our Carrier Screen Panel, and we saw high single-digit, low double-digit growth from a volume standpoint in Q4 and then into Q1, and then we ran into the order management struggle. I call that out just to help people think through when you want to estimate the impact of the order management challenge. We attribute largely the change in volume trajectory to that disruption. Again, we were growing at high single-digit, low double-digit, had some product enhancements. We were getting traction with those.
We've changed from 10% growth in Q1 to down 4% for the year.
Oh.
Got it. Maybe Sam, if I could take a step back and I mean, there were challenges last year. I mean, you had EMR, you have the order management issues. You know, can you maybe talk to us about the effort you've had across the company in order to address or put in processes to make sure that further such surprises really don't arise? I mean, I think that's been one of the questions from an Investor's mind, that there's always potential surprise suddenly.
Yeah
in a quarter. Maybe just talk to us. Is there any concentrated effort to do that?
Absolutely. Yeah, I appreciate the question. You know, when I talk about just my fundamental way of leading a company, I talk about three pillars. This is mostly internally, but just to give you this insight.
Mm.
You know, talk about having the right strategy and the right products to go along with it. I feel like we've really made progress on that. Next, you have to have the right Team, the right Organizational Design. We've made a lot of changes, and I think, like, we're building the right Team. Number 3 is about Execution Excellence. Let's be honest, this has not been the strong suit for Myriad. I think, just like you've asked the question, the fact of the matter is you can't just say, "Okay, let's get better." What does that mean? You can't do that across 2,700 people. The way we've done it is the combination of programmatically putting processes in place. How do you actually launch something? When can you even launch something?
Mm.
When are you on a freeze?
Yeah.
What are the checks and balances? How do you use sandboxes and other things on a tech thing?
Mm
before you actually launch more broadly? We're putting a very significant new methodology, which is not new. Some of us have used this at other companies.
Mm
To really how do you even go from Ideation to selecting what you're going to develop in a product development process with these phase gates in a much more disciplined way so you can launch on time, on budget with the specifications? These are things that we are actively programmatically putting in place, and those things are not just one. This is cross-functional. It's not just R&D. It's R&D, it's operations, it's commercial, it's reimbursement. These are the major programs. Along with that, I don't think you can just train folks. You gotta have enough people embedded that have done that, understand what excellence looks like.
Mm.
'Cause then when you see the early leading indicators that something's about to go off track, these leaders can help jump in. It's not just leaders. You need people at every level. That has been part of the deliberate, the folks that we've added over the last year, including Vishal Sikri as our new SVP of product, who as you might know, was a president at Neo and Abbott before that. You know, others like the gentleman I was mentioning from Guardant Health and other places, people that understand what excellence look like. All of these combination, I think, are parts of how we're getting better. I also want to say that it's not. You can't just go like that.
Mm.
It will take time, however, before we become excellent.
Mm
We're already better today than we were a couple of quarters ago.
Got it. Just given the time, let me just briefly touch on FirstGene. Due to launch the FirstGene mother-only assay in H2, you know, after reading out the CONNECTOR study.
Yeah.
Yeah.
That's right. We're actually on track to launch in Q3.
Okay.
We'll start ramping up maybe even as we get to that CONNECTOR study. We'll read out in that timeframe. At least we'll have a readout before we go broad with that. The reason we're excited about this, there's three things at least, combination of these three factors that we believe give us a differentiation. One, at least as we understand it now, it'll be the only test that you can do at eight-week gestational age versus 10 or 12 weeks. Again, that's natural cycle when a mother comes in for a whole battery of other tests. Convenience for the mom, convenience for the Healthcare System.
Number 2, the way our test is developed, the report actually comes at one time with both the NIPT, NIPS, as well as the Carrier Screening Information, RhD, as opposed to a reflex methodology that the other companies are using. That's convenience, and that's a week, 10 days, what are we going to talk about in terms of advantage. Number 3, one of the things we've heard a lot is, where we've shined and differentiated in Prenatal, has been the support that we're able to provide patients and providers ahead of the testing. Like, "Why should I take this? If I do, what might the result be? What do I do?" Post-result, particularly when you have a genetic issue.
Those things, having more genetic counselors than any company in this country, I think give us a reason, along with the reach, the dedicated prenatal channel which we've instilled, I think is going to make our FirstGene launch successful.
Is there any risk to, you know, Cannibalization of the carrier screening as a result of launching this assay?
I mean, we built into our model some minimal level of Cannibalization, but we have these two other factors going. You know, our other lead competitor who's launched an assay like this has really proven the opportunity to expand the market, and they've shown that, right? Because we know more than 2/3 of the fathers aren't available in the picture, so it's opening up a market. Number 2 , Puneet, I say this a little bit tongue in cheek, but given our level of share, there's so much opportunity to go take share from others that, I'm less worried about cannibalizing ourselves and more excited about the opportunity in the market.
Yeah. Well, that's all the time we had, but I have more question, but anyways, we'll follow up later. Thank you for the time here.
Yep.
And-
Thanks for having us.
Thanks, Puneet.
Appreciate it.