Welcome to Day two, the 45th Annual TD Cowen Healthcare conference. I'm Kyle Boucher , an associate on the Life Science and Diagnostic Tools team here. Pleased to introduce Myriad Genetics. I have Sam Raha, COO and soon-to-be CEO of Myriad, and Scott Leffler, CFO. Thanks for joining us, guys.
Pleasure to be here. Thanks for having us.
Maybe we can just jump right into it. Sam, you know, last week it was announced that effective April 30, you'll be appointed CEO with Paul stepping down. Over the last four and a half years, Myriad has improved its customer perception, elevated the growth rate, driven stronger collections and cash flow, and generated more consistent results under Paul. I guess as you sit here today and look ahead to the next few years, where do you think the biggest opportunities are for Myriad? How might your leadership style differ from Paul's? Starting there.
Thank you for the question. First of all, very grateful to Paul and the leadership team for the work, the very hard work that was done over the last four and a half years really to kind of give us a chance to really be a growth company now, right? Hard choices, divestitures, restructuring, a number of things that were done. I think there's a number of areas as we look at the years ahead to be excited of. First and foremost, really to really serve the fuller continuum of cancer care, building on the hereditary cancer franchise that we have. We could do more there and unaffected, building on to therapy selection. You might recall we bought some assets from Intermountain Precision Genomics last year. Now we have that piece. This is going to be an important year on MRD.
We can talk more about it later, but milestones being data to be shared at ASCO, MolDX submission, and so forth. That is the fuller cancer care continuum that I'm excited about. Listen, to be a differentiated provider in prenatal and women's health is also an opportunity we have. We just recently introduced a differentiated early gestational age at eight weeks NIPS test. We have something called FirstGene, which will be really a combination of NIPS expanded carrier screening coming out. For all of that, as I look ahead, it's about how do you do that by leveraging some real points of differentiation, be it the access and established reputation and trust of more than 50,000 healthcare providers, be it, as you and I were just talking about offstage, these world-class labs that we built for turnaround time, reduced cost, high quality.
The investments we've made in digital, between digital and infrastructure, over 75 million over the last three years to really think about the pull through, ease of use, and driving volume through EMR and all that. Those are some of the things that I think are exciting about the year ahead or years ahead. You asked about maybe difference in style with Paul. I think the opportunity for me is to come in with a fresh set of eyes, fresh perspective, and look across all the things we're doing and say, are we in areas investing not enough or over-investing? That's one opportunity I'm looking forward to. Another one is to really relentlessly focus on things that drive accelerated growth. What are the things organically and inorganically that we can do?
Third, I'd share with you, I think there's a real opportunity for us to simplify the Myriad narrative and the Myriad story, both internally as well as as we share it with you. I think there's a lot of moving pieces. I think we could do better on that. Finally, to establish a pattern of meeting timelines and expectations. Looking forward to that and with my colleagues and on what's been built ahead of us to really make Myriad a destination for patients, for providers, and hopefully investors as well.
All right. I guess moving to Scott then for a second. You've been CFO at Myriad for a little over a year now. The transition between executives can sometimes create disruption. Can you for a minute reflect on your first year at Myriad? I guess what maybe has been the most surprising thing to you about the company over the last year?
Sure. Thanks for the question. I guess I'll just say that it's been a wonderful first year and change with the company. In terms of the executive transition, I would say that it's been a pleasure over the last year and change to get to know Sam and Mark Verratti so well and to see them grow into this change and expansion in their respective roles. I think the way that it's been handled internally has really been seamless. It's a testament to their capabilities and to the receptiveness of the organization overall to their leadership. Definitely excited about what the future holds in that respect.
I think in terms of the other parts here in question, as far as surprises during my time here, I would not characterize anything really as a surprise per se, except to say that really the differentiators in the business and also the manifestation of some of the investments that have been made over the last several years have really resonated with me more and more during the time that I have been here.
Certainly, I think with investors and other stakeholders, when you think about some of the investments that we've talked about, certainly during the last year that I've been here, whether it's the culmination of the Labs of the Future program and investments, the investments that we've made in EMR, the investments that we've made in revenue cycle capabilities that had such a tremendous impact on our financial performance in 2024, those are just kind of headline examples of the significant investments that we've made that are having payoffs or will have payoffs in the next few years. I think it's really just a testament to Paul's leadership during the last few years and the willingness of the company to make the investments that were necessary in order to make sure that we're at the front of the pack.
Got it. All right. Maybe just a sort of high-level one on guidance this year. Before the UNH GeneSight announcement late last year, Myriad raised the long-term top line outlook to 12%+ growth. At 3Q, you discussed the underlying business excluding the UNH GeneSight revenue. Instead of being an $845 million business growing 12%+ , you were an $800 million business growing 12%+ . I guess in the context of the guide this year with the underlying business growing 8% to 11%, can you talk to about the level of conservatism that's baked into the guide this year given that it's under the long-term range?
Maybe I start, Scott, and then you add in. I think that as we developed our guidance for this year, 840 million to 860 million on the top line, what we factored in are some of the things, Kyle, that you just mentioned, right? There is a UnitedHealth-related impact, even though that's boxed away, not in our numbers, but just working through that as one element. Without a doubt, I think everyone knows there's been some angst in the marketplace as well as with investors related to Prolaris, our prostate cancer test and what is what's happening there related to NCCN guidelines. We'll come back to that and talk about that. We also in the quarter in Q4 saw a little bit of sluggishness in the volume, which we attribute to two things, which will just take a little bit of time in 2025 to work through.
One is we're very excited about the continued opportunity in hereditary cancer, particularly for the unaffected market, right? It's a 2.7 billion market growing somewhere between 7% to 10%. It's only 10% penetrated. We have the right to win there. We're driving major programmatic, systematic things like the Breast Cancer Risk Assessment Program. It's just taking a little while to kick in, though we have some good indicators of where that's going. The EMR integrations, right? We know that one of the most important things to really drive volume is to make it easy for our healthcare providers to both learn about, select our tests, and get results in the EMR systems. We did 4,500 site integrations last year, but it's taking a little bit longer than we had anticipated to actually activate and see the benefit of the pull through of that.
By the way, we're doing something about it. We're not just saying, well, it's going to take a while. We've activated, if you will, Navy SEAL teams that are really all about customer success and making them success and do that. We've also factored in the reality of it's a year of transition. There are things related to that that we just might or might not anticipate. As I hand it off to Scott now, despite this year and how we're looking at it, I mean, I think it's about blocking and tackling. We feel really good about double-digit growth in the years to come, but it's a year where we have to work through a number of things.
Yeah, I think you covered all the most important points there, Sam. I mean, obviously, GeneSight in recent history has been our fastest growing revenue driver. There is kind of a mathematical phenomenon, right, when it represents a smaller proportion of your total, and that creates a near-term headwind to the growth profile as well. I would just emphasize some of these initiatives that were something of a headwind in Q4, this question of how quickly we're able to flip them to the point where they become additive to the volume growth trajectory is really the important determinant here. The other thing that I'll add, because I think we're focused on volume type drivers right now, is that we do feel really good about the ASP momentum that we had coming out of Q4.
Q4 was a very strong quarter for us in terms of organic ASPs. We were talking all year about the fact that we felt good about at least being able to hold the line on ASPs and potentially generate an incremental add, which is obviously very different from what the narrative has been in prior years. That, in addition to this question of kind of how quickly we can accelerate the volume trajectory, that opportunity on the ASP front is one that we're going to try and drive.
Got it. Got it. On the EMR integration, you just talked about the sizable investments that you guys have made. Can you frame the potential volume impact on hereditary cancer maybe across the rest of your portfolio from integration with these EMR systems? How much more runway is there to improve volume and efficiencies from EMR integration? Are there any systems that you're not yet integrated into that you'd like to be?
Yeah, great question, Kyle. Just to kind of frame with some facts, even with the 4,500 integrations we did in 2024, more than 1,500 in the year before, believe it or not, still less than 25% of our volume comes through EMRs. Now, some of that is because, believe it or not, smaller healthcare practices still like paper and faxes. There is an inaccessible part. There is also just the churn of new providers that come in and so forth. I think there is a material opportunity, I mean, of at least one to two percentage points of opportunity for growth from really enabling EMR systems to be easy to use, both from making it easy to order more of the tests that they are already ordering.
Then once it's in the menu and you're the trusted provider, we think that this is where we can get the connectivity across products, right? You start with a cancer patient, for example, with the hereditary cancer perspective, but you add in therapy selection and ultimately when you have MRD. We are working with over 20 different EMR providers. There are so many nuances, even with the various versions of Epic, for example. All the major systems, Epic, Athena, Flatiron, Lumea, for example, on the urology channel, we have it. I think there's a lot of opportunity that continues ahead to really be accretive to our growth in at least the next three to five years. I mean, Scott, what would you add or subtract from that?
I think that covered it pretty well. I mean, I think the upside opportunity, considering where we're coming from to where we're going to, it's been an important investment to have made. Even if there is any kind of near-term headwind in terms of just the ramp, it's certainly worthwhile and positions us for longer-term success.
Got it. Okay. So then again, on the hereditary cancer business, grew somewhere in the low double digits in 2024. Volume was up mid-single digits year over year, favorable pricing. In the context of your long-term guide, how should we think about the outlook for hereditary cancer over the long term? Maybe can you bifurcate that between the affected and unaffected market? Because it sounds like you know there's much more opportunity on the unaffected side. What's your strategy on both sides of that business to support the long-term guide?
You want me to start? You want to start?
Sure.
Yeah, go ahead. Yeah. I mean, first, just to frame it with some numbers, right? We see the affected side, which is the more competitive part of the market, it's around $1.7 to $1.8 billion market, growing in the mid-single digits. This is where we're actually third, right, in share because Invitae and Ambry, now LabCorp and Tempus, they have the leading franchises. That being said, we see an opportunity for growth there, particularly the time of transition. This is a question, Kyle, we often get like, well, didn't that LabCorp acquisition happen like seven months ago or eight months ago? The real putting into effect the new pricing, the new terms and conditions have only gone into effect this quarter. That still gives us that opportunity. Of course, Tempus acquisition, Ambry is much more recent. We see an ongoing opportunity.
It is a market that's already very penetrated, almost more than two-thirds. We absolutely are taking the opportunity for this potential disruption in the market to go in there and revisit all those folks. Part of what's going to help us too, by the way, we've already announced by the end of this year, we're going to have an updated MyRisk panel, which will have all the relevant NCCN updated genes and with the number one still gold standard test with MyRisk. The unaffected market, right? That's a bigger market. I think I might have mentioned that's over 2.5 billion to $2.6 billion, and that's growing high single digits, low double digits. We have the right to win. We are the leaders. There's 50 million women just in this country that qualify for hereditary cancer testing that aren't getting it. It is a programmatic approach.
It's also just lining up with data, our sales folks, where to go. It's using digital. It's using other programs. It's actually using our providers to drive the awareness and demand. I think we've mentioned this in the past, maybe not recently, but we continue our efforts to also work through imaging centers and other places where a woman or even men would go for customary testing, right? That's another angle. We still see a lot of opportunity. When you look at our numbers, by the way, for hereditary cancer last year, it's also a little bit confounded by the fact that we've had historic tests like BRACanalysis, those tests that have been declining, which make the overall category look maybe our report to be not as strong as we've actually continued to grow.
Yeah, maybe I'll go into a little more detail on that because I think it's important to understanding our overall trajectory on hereditary cancer testing product category. When we report our hereditary cancer testing volumes and revenue, it includes the aggregation of really three groups. One is MyRisk for affected, MyRisk unaffected, and then this Braxedia X category that really is kind of running its course and is dilutive to the overall growth profile. That was expected. When you look at the growth performance for MyRisk on the affected side, it was generally a double-digit volume grower last year along with really strong performance on the ASP side. That part of the business, there's opportunities for incremental acceleration over the long term, but we're pleased with a double-digit volume growth performance there.
Really the area where we know we need to accelerate volume performance is on the MyRisk unaffected side. That is where we have called out some of these near-term headwinds in terms of EMR integration and kind of conflicting prioritization for the commercial organization. Those are things that we think we can rectify over time. Certainly along with displacement in the competitive landscape and other initiatives, we think that we can accelerate the volume trajectory there.
On the competitive front, you mentioned these other two competitors now, LabCorp and Tempus. This disruption has been something that's been ongoing for a couple of years now almost. You talked about being the third out of the three, but do you have any estimate for what your actual share is? Is there anything you can share on the share that you've gained over the last few years given the disruption?
Yeah, Kyle, I'll start again with actually just restating the market reality, though we say the disruptions have been going on for some time. From an investor perspective, yes. From a healthcare provider perspective, not really, right? I mean, when they're testing and then you're still providing the test from Invitae and so forth, it was remarkable, but this is their world. They're like, what are you talking about? Now, some of them are aware. The market opportunity for the gains are still very actively happening now. I would say from our estimation, both of those companies have about equivalent leading share, probably a third of the market each. Our share is closer to somewhere in the high teens or 20%. The opportunity is to equilibriate from there and get more share back.
I think we've held our own for 2024 in affected as Scott was talking about. If the market's growing mid-single digits and we're able to grow double digits, unless we're off on the sizing of the market growth, I think that means we've done well.
Maybe shifting away from hereditary cancer and over to MRD, you've had several press releases over the last few months relating to IP around MRD over the last few months. Can you take a minute to speak about your strategy in MRD? When do you expect full commercial launch of your assay? What are the milestones we should be looking for over the next year?
Yeah, no, thank you for asking. First, just as a reminder, our MRD test, we are late to market. Without a doubt, we know that. The reason that we believe we have an opportunity and a right to play is two things. One, the fundamental assay that we have, which is tumor-informed, whole genome sequencing-based, really provides a level of sensitivity to be able to look at two to four parts per million in a blood sample that really matters compared to the other tests for low-shedding tumors like breast, like ovarian, bladder, and so forth. That differentiation will make a difference in actual clinical care. Number two, we have access because of our established footprint into all the leading community docs and healthcare providers, right? Over 10,000 over 20,000, sorry, between primary care and oncology.
Now, to answer your question more specifically, this is an important year for us. The milestones that I would say that you and other investors should be looking at include coming up at ASCO here in June, the first time we'll be really sharing along with collaborators clinical information about the tests, some of the work, the collaboration we've been doing. Number two is the submission by the end of the year to MolDX related to our first indication with the planned expectation that within the first half of 2026, we'll have a commercial launch. To remind you, because I know this is an important question, though we're working on a number of cancers, the first indication that we intend to bring to market is breast cancer. Again, because we have the channels, we have the right.
Between our almost 20 clinical studies that we have going in MRD now, it's more than 4,000 patients that are either already enrolled or in the process of being enrolled. That'll give us more than 30,000 collective data points, which are part of this study. I think we're making progress, but absolutely to make it real, those are important points to look at as this year comes up.
All right. Yeah, maybe one more on the oncology side of the business. You announced an exclusive partnership with Pathomic last week to use their AI technology platform within your suite of oncology products. Can you discuss the rationale for this deal and what do you think it means for Myriad?
Thank you for asking. We're really excited about this deal. We've been looking for some time about how do we complement what we have to really think about where is the market going? When I say that is diagnostic testing, clearly we are one of the leaders in molecular-based diagnostics, but clearly there's a place for AI-enabled, AI-guided diagnostic testing too. Clearly we're not first to market there. The big competitor that's really made a point of differentiation there. What excites us, Kyle, is the following. We chose Pathomic for a number of reasons. We wanted to solve for prostate cancer, which has been a really good franchise for us with Prolaris, but over the last couple of years, we have been losing share to Decipher and Veracyte.
The reason we chose Pathomic is this is a set of experts in prostate, number of MDs, PhDs, deep roots, experience, access to samples and data and KOL in prostate health and prostate cancer. Two, immediately our first test that we'll be bringing to market with them commercializing will be in the part of the prostate cancer journey that we don't address at all today. It's all Decipher, which is what do you do post-radical prostatectomy or post-radiation? We expect to have a test for that by the end of the year that we'd be able to commercialize. We're also excited about the relationship. There's three reasons. Number two is it'll give us, this is still part 1B, a joint offering at the time of biopsy where Prolaris is. That'll fortify that also by late this year, early next year.
Another reality in the prostate cancer space, unlike any other test, excuse me, unlike any other cancer that NCCN opines on, this is a place where you have something different about addition called SIMON Level 1 or SIMON criteria. We've been challenged to get the samples that we need to actually gain SIMON Level 1 evidence. Now, with this partnership with Pathomic, we are already seeing a lot of collaborators leaning in because they are happy to collaborate when they have an opportunity to engage on AI and molecular together. It is going to accelerate what was otherwise going to take us three to four years to get to SIMON Level 1. I think it is going to cut that off by at least a year, year and a half. That will help.
This is starting with prostate cancer, but it also gives us the path, the AI capability in this partnership to expand into other cancers in the years to come.
All right. Maybe moving over to GeneSight then. Not on the UNH GeneSight side, but think about the underlying business. I think results in 4Q volumes were pretty strong, growing over 9%. Total revenue grew mid-teens. How should we think about the sustainable growth rate for GeneSight volume? Should we expect a continuation of mid-teens plus growth on the current volume base? I guess can you speak about how reimbursement is trended for GeneSight excluding UNH? What's your view on incremental payer wins for GeneSight?
Do you mind taking this one to start with?
Sure. I think we've said in the past that we don't intend to guide at the individual product level for 2025, but generally speaking, we continue to believe in the long-term potential of the GeneSight franchise. We're continuing to invest in commercial penetration, ease of use, and ease of ordering and things like that. Over the long term, we certainly continue to believe in the growth potential for that business and that product. I think you were alluding to throughout 2024, separate from the United Coverage determination that attracted so much attention in Q4, we were reporting incremental coverage wins throughout the year for GeneSight and continue to have our payer markets team focus on coverage wins for GeneSight. We continue to believe that there's opportunity there.
Between the long-term volume opportunity or the coverage opportunity, we continue to believe that GeneSight is going to be a grower for us over the longer term.
All right. Maybe moving over to prenatal then. You're launching your combined carrier and prenatal screening test this year, FirstGene. You've discussed how only one in three patients undergo both carrier screening and non-invasive prenatal screening during pregnancy. FirstGene combines the two tests into one. What's your key competitive differentiator with FirstGene? How could this meaningfully inflect prenatal revenue and volume?
Yeah, great question. Just to, I think we've used different terminology on this. We're doing our pre-launch this year. By the way, we're on track, Kyle, to launch next quarter for that. We're excited. It is a sizable pre-launch though because it includes the target of serving more than 4,000 patients. Working with dozens of providers to do that. We are excited because you've already stated the facts, just how infrequently, if you will, that the benefit of both are provided to parents. What's really going to be different here is that from a single blood draw, we're able to provide information that allows the parents, the mother, and the healthcare providers to still understand before a child is born at the time of birth how to be really ready to address various genetic conditions that may manifest.
We're also excited because the way we've developed the test, essentially we're able to get the benefit by one workflow in the lab. Our costs are significant. It's not one plus one. It's significantly less than having to add those up together. The way we're going to market, we're going to be able to at least start by stacking the codes, even if we don't get paid 200%. I think that the economics are good as well. Now, we think it'll take some time for the market to fully absorb that. What excites Myriad, though, is that listen, when it comes to NIPS and expanded carrier screening, there is a dominant gorilla, if you will, in that market, right? For us, this is giving us an opportunity to go to a lot of different providers where we're not the obvious choice with a differentiated offering.
I think that there is enough distinction that there are some folks who are our existing providers who will continue to use either Prequel or Foresight, but this will allow us to really target a part of the market that we're just not able to address today. Yeah.
I think you covered it.
All right. Maybe in the interest of time, I'll switch to state biomarker bills. Any update on what the opportunity means to Myriad right now and what you've seen thus far?
I mean, we're not quantifying the opportunity per se. I would just say that biomarker bills, we kind of characterize it as being arrows in the quiver in terms of all of the different arguments that our payer markets organization has to bring to bear when they're in front of different payers in order to win a favorable coverage determination. Certainly, when you look at the positive contribution that we had from organic ASP momentum in 2024, we had a contribution there with a number of payers that were directly attributable to biomarker bills. We believe that there will be more positive momentum across our product portfolio in 2025 and going forward.
Maybe, Scott, for you, moving to profitability. We model a steady improvement in margins, both gross margins and EBITDA margins looking out with you guys EBITDA positive going forward, including this year. Can you walk us through how the company's planning on cost trends in the path to maintaining profitability alongside growing the top line?
I know you're posing the question to me, but some of the cost answer, I think, is better coming from Sam. We have a number of initiatives in order to make sure that we're always almost kind of maintaining a continuous improvement mindset. There are a number of areas in our infrastructure that Sam can speak to where we know we have opportunity to reduce our cost structure. I will say that we don't necessarily view, at least at the gross margin level, the medium and longer-term trajectory as continuing to be more positive, not because of anything negative that's going on in the business, but because as we introduce new products, then those new products will be diluted to the margin profile. Again, that's for a good reason because it's just part of the normal maturation of a newly launched product.
It is great to know that we have these other favorable drivers in our cost structure that are helping to absorb any kind of dilutive impact from new product launches.
You know, the one important thing that I would add, thank you, Scott, is the following. I think in the spirit of a new administration, new way to look at the company, I think there's an opportunity to say, hey, if we had to make a trade-off, we're going to remain profitable on a just basis for sure. We're not intending to go backwards. However, I think growth and aggressive sustained growth, accelerating our growth and considering that the trade-offs to do the things, investments to do that, is something we're going to actively look at. Please give us a little bit of time to work through the new perspective. I want to focus in on sustained accelerated growth for Myriad as more important than just growing profit. We'll be very deliberate and we'll share why we're making choices if we are to alter that.
All right. I guess last question for you guys. What excites you most about the story and what are investors missing?
I'll go first. I mean, listen, I think that at a high level, it's an opportunity to take a company that has a lot of fundamentals, has good potential to combine that with focus, execution excellence, and make it a company that's about potential realized. I think we have the foundational pieces. We have the oncology pieces. I think it's about focusing and choosing what not to focus in as much. I think we've got a great franchise and the best days are to come for the company and for the patients that we serve and for our investors as well.
I would just emphasize the power of the diversified and scalable model. I know we've had a couple of challenging headlines relating to several of our products, but when you look at the overall product portfolio, there's a lot of power there to how well diversified it is. The scalable infrastructure that we've got at a point in the profitability curve where we are profitable on an adjusted EBITDA basis is a really attractive point to be in to then point yourself towards further growth and further profitability.
All right. With that, we're out of time. Thanks, Sam, Scott. Really appreciate it.
Thank you for having us, Scott.