Hey, guys. Good morning, and welcome to day two of the Morgan Stanley Healthcare Conference. I'm Tejas Sawant, and I cover the life sciences here at MS. Well, before we get started, important disclosures: please see the Morgan Stanley Research Disclosure website at morganstanley.com/researchdisclosures. If you have any questions, do reach out to your sales rep. So it's my pleasure this morning to host Myriad Genetics, and speaking on behalf of the company, we have Paul Diaz, President and CEO. Thank you for joining us, Paul.
Thank you.
You know, Myriad has transformed meaningfully versus where the company was four years ago. You know, you've been with the company for a bit. What's changed? What stays the same? And can you outline Myriad's key accomplishments this year? You know, what are you particularly proud of, and is there anything you wish you'd do differently?
There's always more work to do, for sure. I would say that we're really proud of how the team has come together. We've built a lot of capacity, both in terms of the team-
Mm-hmm
... and our processes. I think our ability and the industry's ability to, to be part of a broader healthcare ecosystem and be successful in that ecosystem is gonna depend on systems and process-
Mm-hmm
... and leadership and people. So, we are nearly complete with our Lab of the Future, the industrialization, if you will, of our labs-
Mm-hmm
... to be able to do, you know, large volumes at low cost. Really proud of the quality measures.
Mm-hmm.
We've just been through FDA and New York State surveys in our new labs, and zero deficiencies. So these are things that you can easily take for granted.
Right.
Turnaround times across the board, improvement in ASP across our product portfolio, our net promoter scores with our customers-
Mm-hmm
... in a market where there's a lot of dislocation and-
Mm
... fear and anxiety. I think we have reemerged as the go-to, high quality, solid science, reliable partner for health systems and providers.
Mm-hmm.
That's generating the kind of organic growth that we've been looking for, and we think that'll accelerate here in the back half of the year.
Got it. Fair enough. You know, I want to start with pharmacogenomics, Paul. You know, given the news yesterday, just around that discontinuation of the health economic study, you called out, I think it was control group disparities. So let's start there with GeneSight. You know, can you just elaborate on what happened?
Yeah. So we continue to be very excited about the health economics and the clinical utility of GeneSight. And again-
Mm-hmm
... just to reaffirm, this had nothing to do with clinical validity, and we continue to get great traction. We even signed another payer last week, and so we don't see this affecting the momentum we have with payers, coverage, or adoption.
Mm.
What we were trying to demonstrate was that phase one showed a significant reduction in hospital utilization and cost, 29%-39%.
Mm-hmm.
And so what we were trying to do is isolate what portion of that was specifically determined by GeneSight-
Mm-hmm
... in the control group. The data was unable to do that.
Mm-hmm.
It does not mean that GeneSight did not contribute to those big numbers. The question is, what other therapeutic changes, medical management changes, may have also, in part, because of using GeneSight, demonstrated those savings?
Mm-hmm.
The work with our partners just didn't demonstrate the ability to parse out how much of that 29% or 39% savings were attributable to GeneSight specifically.
Mm-hmm.
And we didn't see a path to getting there. So no issues with the integrity of the data. This is one of the biggest data sources in terms of claims in America, and it is hard to under any reasonable circumstance not come away that whether you're looking at the 29% or the 39%, that GeneSight helped contribute to that better medical management and cost reduction. And so I could have done a better job explaining that yesterday in the 8-K. We were trying to just report the news.
Mm-hmm.
But zero impact on the trajectory we have with payers, coverage, and ASP right now. This would have been a nice ad-
Mm-hmm
... for the story on economic utility, and we'll publish phase one, 'cause again, it showed material savings with respect to the GeneSight cohort.
Got it. In terms of just what those disparities were, Paul, that led to, I guess, lack of statistically significant difference between the GeneSight arm and the control arm, is there any color you can share? And was this really a situation of your research partner here assembling the cohort? Like, was that the issue?
Yeah. I mean, I haven't pored through the initial report, and what we did, we want to be reporting the news as we see the news. So they were not able to distinguish-
Mm-hmm
... what other things in the medical management of the patient may have been the causal effect to that reduction in cost versus GeneSight. It does not diminish the fact that 39% of the patients that used GeneSight versus those that didn't-
Mm-hmm
... had savings.
Mm-hmm.
You know, I'm sure Dale and the rest of the team can parse through that in a little bit more detail.
Mm-hmm.
But there were no issues with the integrity of the data, and it was just a question of being able to separate the cause versus the effect with respect to the control group.
Got it. Now, your comment on, you know, the commercial implications of this readout, help us contextualize the data, right? You talked about this being one aspect of what gets payers on board, what gets physician buy-in. How should we sort of feel confident that the payers or the ones that aren't covering GeneSight today won't start pointing to this and dragging their feet for a little bit longer?
Yeah, look, again, I think it would have been additive to the story, but we have significant momentum. We talked about Blue Shield of California-
Mm-hmm, mm-hmm
... a few weeks ago. We are using the biomarker laws across many states. Many states are still in the process of passing those biomarker laws.
Mm-hmm.
The great strength of GeneSight, for anybody who has a family member or struggle with depression, the value proposition is getting on the right drugs faster.
Mm-hmm.
That is compelling to all the nurse practitioners, all the physicians, and the payers see value in that as well. And so, you know, while it would have been great to have additional health economics data to support the 39% reduction in hospitalizations, again, it's, it's-- there's no doubt in the thousands of patients that we're using and the feedback we get from the data that we are collecting in the PHQ-9s, that GeneSight is proving itself to be a useful tool in the medical management of people with anxiety and depression. And so we don't really see in the customers that we have today or the payers that we have contracted with, including a payer that we signed last week-
Mm-hmm
... affecting the trajectory of GeneSight. It certainly would have been a nice boost to accelerate that adoption-
Mm-hmm, mm-hmm
... accelerate that coverage. And we're gonna keep working on clinical validity studies, clinical utility studies, because that's our job for all of our products that continue to support the use cases. But again, we don't see it slowing down the double-digit growth and the ASP strength that we've seen in GeneSight here recently. And we think yesterday, again, maybe some more clarifications on my part would have been helpful, but we don't see it diminishing the trajectory for GeneSight. And certainly, we're not seeing that in the numbers, you know, as we see this quarter.
Got it. So what's next on that health economic study? Will you sort of work with them to create a new sort of control arm, and then, you know, publish those data at some point?
We'll definitely gonna publish the results of phase one-
Yeah
... and make that clear. And we're still working with, you know, our partners there to determine whether or not there is an ability to access-
I see
... the data. So it's just not clear yet.
I see.
At this point, there's just not a clear path.
Got it.
Just not value-added. Again, we'll be looking at other ways to continue to validate the clinical utility of GeneSight.
Got it. You highlighted a couple of payer wins, including, you know, Blue Shield of California on the biomarker law, and you've got, I think, another 12 states beyond California as well, signed up for, you know, covering GeneSight, I guess, as part of that legislation. What's the response been from clinicians, and have you seen an uptick in the adoption rate in California?
It's a little early. I haven't gotten any data on California specifically.
Mm-hmm.
But I was there a couple of weeks ago and actually with the folks from Blue Shield and, you know, we do expect to see an increase in both adoption and payment.
Mm-hmm.
And look, you know, kind of strange for this industry, but really pleased about cash collections this month and the trajectory of that.
Mm-hmm
... and what that says for the underlying strength of the business, so that's the only thing I know right now about-
Got it
... the first couple of months is how strong cash has been these last two months.
Fair enough. I know you don't sort of manage the franchise, in terms of just purely the no-pay rate, but, you know, I think for GeneSight, it's about sort of 60% today, right? So as you think about the next three years, you've got these biomarker wins coming through. How do you see that ASP trajectory over the next sort of two to three years?
Yeah, I think that's one of the great levers. We'll talk about the other levers for growth here.
Yeah.
And again, I think that one of the things that we've tried to do is, really refine the portfolio. You've seen us over the last few years, try to be much more focused-
Mm-hmm
... on products where we think that we can grow and, and be successful. And GeneSight, certainly one of those products. We expect to see continued double-digit volume growth.
Mm-hmm.
We continue to see ASP growth, not just as a function of the biomarker laws, but of all the other work our payer markets are doing-
Got it
... and the progress that we're making with payers, again, demonstrating the clinical utility. We've entered into a couple of value-based arrangements.
Mm-hmm.
You know, the economics around GeneSight are pretty compelling, so it gives us the ability to enter into value-based-
Mm-hmm
...arrangements and put some risk.
Mm-hmm.
Those are exciting arrangements, too. We do expect to see continued growth in ASP.
Mm-hmm.
You know, low single digits, probably, but maybe more.
Mm-hmm.
That's certainly one of the levers to sustain our 12% growth number that we talked about and gives us a lot of confidence there. Again, even in the last couple of months, we've seen, you know, some nice payer wins and acceleration of ASP for GeneSight. You saw that last quarter.
Yeah. What does repeat ordering among physicians look like today? And has the GeneSight churn rate improved over the course of the last twelve months?
Yeah, it's improved slightly. It's something we're really focused on. You know, it's not particularly efficient to have, you know, an office order two GeneSight tests a month.
Yeah.
So one of the things that Mark and the team are really focusing on across our portfolio is just better execution on conversions and more wallet share pull-through. One of the things I commented on in the last earnings call, I'm perfectly willing to give up some volume-
Mm-hmm.
-for revenue.
Mm-hmm.
You know, we are much more focused on maintaining access for all patients across all payer types, but this industry needs to get away from giving tests away for free, which is still happening with a lot of our competitors.
Mm-hmm.
Free cascade testing and different things. One can argue there's some compliance issues there as well. But for us, I think what you have seen the last couple of quarters, and you—I think you should expect to continue to see, is double-digit revenue growth at 12% target, in part on just being smarter about what customers-
Mm-hmm
and focusing on selling products that we can get paid for.
Fair enough. All right, let's transition to hereditary cancer. You talked about, you know, stable average revenue per test for next year. You know, traditionally, folks have looked at this market as one where you see, you know, a degree of pricing pressure. I think your new guide assumes about, like, low single digit, sort of ASP growth here versus a, you know, 3%-5% decline in the past. How much of that is a function of, you know, peers like Invitae exiting the market versus key payer contract renewals for you? And how are you thinking about pricing in 2025?
Yeah, I mean, consistent with that commentary, you know. Look, I think the dislocation in the market at the margins has improved. We're not seeing. You know, typically, we were seeing $30 million-$40 million of headwinds in terms of pricing, contracted pricing.
Mm-hmm.
We said in the early years of our transformation that we were more than making up for that with rev cycle.
Mm-hmm.
And-
Mm-hmm
... and you saw that come through in out-of-period collections and other things. We're just not seeing that kind of headwind.
Mm-hmm
... in the near term, and certainly we're not seeing that for hereditary cancer. Part of what is guidelines continue to expand. We've increased penetration for unaffected patients with payers, which is still the most under-penetrated market.
Mm-hmm.
And you've seen over the last couple of quarters, really, just the progress from rev cycle and contractual wins. So, for example, our big four-year contract with UnitedHealthcare.
Mm-hmm
... it wasn't about the contracted rate, it was about coverage.
Hmm.
You've seen ASP in that contract improve because our no pay came down by 10%.
Got it.
And so, we've always talked about ASP, Average Revenue Per Test, being less about contracted rate-
Mm-hmm
... and more when you're talking about an industry that doesn't get paid, and I think others are worse, 44% of the time-
Right
... getting paid for what we do and selling for what we can get paid.
So I guess on that point, Paul, how much runway is there in terms of these revenue cycle management initiatives and efforts to minimize the no-pay rate? How long do you see that sort of being able to offset or, I guess, even more than offset the contract renewal pricing pressure?
Several more years.
Okay.
I mean, we are still in the early days of... You know, Scott talked about this on the last earnings call. We've engaged PwC to help us with a number of new tools. Our EMR efforts not only help us bring on new customers-
Mm-hmm
... you know, the big customer wins that we're seeing, but every time we get a big customer on EMR, we're able to pull prior off.
Mm-hmm.
We're able to pull medical necessity documentation. All of that helps with no pay and rev cycle and ASP. So we just see, and I think what's interesting, is you're seeing a lot of interest from our competitors in hereditary cancer. And more and more people recognizing that for so many cancer indications, hereditary cancer is an important part of the diagnosis and treatment decision process.
Mm-hmm.
We think there's just a tremendous amount of opportunity still.
Mm-hmm.
You know, more than 50% of the hereditary testing in America is not happening with us, and Invitae, and Labcorp, and Ambry. It's happening in a lot of small LDT labs.
Mm-hmm
... which will probably be regulated at some point here.
Hmm.
Look, we think the hereditary cancer market is growing 8%, particularly when you count unaffected patients.
Mm-hmm.
And men included.
Hmm.
More and more oncologists remind me that family history for prostate cancer, for example, calls for guidelines for men to be tested for hereditary cancer, too. So there are just a number of different levers for why we think hereditary cancer, both for affected and unaffected, will continue to grow both volume and ASP.
Got it. You've talked about double-digit growth in hereditary volume in 2025 as well. How much of that is share gain, you know, following, you know, several peer exits versus just increasing penetration?
Again, our share, if we just get our share, we think that's 8%. So clearly, continuing to get more wallet share and market share gain-
Mm-hmm
... is what I think gets us to 10% or more.
Mm-hmm. Mm-hmm.
So, I don't think those are big stretches, given the market dislocation and the changes that are just starting to happen.
Got it.
I commented that a lot of the acceleration we saw in prenatal-
Mm-hmm
... was due to the dislocation of Sema4 and Invitae-
Yeah
... early in the year-
Mm-hmm
... and it takes time for me to change. I think we will get more than our fair share of some of the dislocation happening right now over the next several quarters.
Mm-hmm.
You know, some of that integration work is just occurring as we speak, and customers are, some customers are taking a wait and see approach, and others are already saying to us: "No, we're moving, you know, business over to you.
Got it. That's actually a good segue to my next question. As you look at the second half of this year on NIPT, what's your sense of, you know, new customer wins versus existing customers now electing to do more business with you, just in terms of that share dislocation you talked about?
Yeah, so excitingly, most of the volume gains you've seen in the last couple of quarters have not been from new customers.
Mm-hmm.
They've actually been really getting great execution from Mark, and Melissa, and Ruben, our vastly improved and more focused commercial teams. It's taken a couple of years-
Mm-hmm
... for everybody to use Salesforce appropriately-
Mm-hmm, mm-hmm
... to target the right kind of customers. And so most of the growth you've seen is really execution. You know, look, when we started this transformation, we were turning 37% of our sales force was turning over. Last quarter, 9% of our sales force turned over.
Mm-hmm.
Yeah. That makes a difference in training, using the processes and systems. So I think much of our... And that's wallet share gain. So I think much of our share gains are still in front of us now.
Got it.
Can we replicate 25% growth? You know, I hope, but I think that's probably a high bar.
Fair enough. Obligatory question on guideline changes. So, you know, one of your peers said yesterday that they would be surprised if ACOG guideline changes got pushed out to 2025. Is that sort of your view as well? Now, I know the upside from that, you know, will layer in over a couple of years.
Yeah.
But-
Yeah
... but what's the latest?
It's interesting. My understanding was that they were a little more muted in their response to that question, which we have been, I think, fairly cautious about not predicting what others can do.
Mm-hmm.
We still understand the guidelines should be coming out this fall.
Mm-hmm.
That's still our understanding. And as you just commented, I think that has in the way that average risk has helped-
Mm-hmm
... you know, improve NIPS testing. We've seen a nice lift from that over the last two years. We think guideline expansion will help adoption and certainly will help ASP.
Mm-hmm.
And that part will take longer-
Mm-hmm
... as we go back to payers with guideline changes. You know, they're not going to be quick to jump on that. But that certainly presents a lift, and I've commented, you know, if guideline changes resulted in contractual changes, we have $20 million of no pay right now that would hit the bottom line immediately.
Got it.
So that it's a pretty large opportunity for us.
Got it. Would you switch from, opt-in to opt-out just to build some momentum into that guideline?
Yeah, I mean, for 22q?
Yeah.
Yes. If guidelines change for 22q, and the expectation, because people want to follow guidelines, would be for 22q be-
Mm-hmm
... to be in, we would move to... You know, it's not an opt-out, it would be in.
Right.
Yeah. So that also could be a nice lift for us. And we'll just, again, have to wait and see, and the team's already preparing for that potential.
Mm-hmm.
The main work right now is to make sure that once guidelines come out, that we're, you know, we pre-launched Foresight Universal Plus with the genes that we expect to be in there.
Mm-hmm, mm-hmm.
We wanted to make sure we were in front of customers in terms of where guidelines were going. Not too far in front, because we're not getting paid for that.
Mm-hmm.
But, but not so far behind that our competitors could say, "Oh, you know, there goes Myriad being behind guidelines.
Fair enough.
So we're trying to thread that needle, quite frankly, with all of our product lines, right?
Got it.
So-
Carrier screening, same sort of question. When do you expect those guidelines? Is it fair to view that as a more near-term change, potentially relative to 22q?
I was really referring to both.
Okay.
I mean, so, Foresight Universal Plus is-
Yeah
... our carrier screening product. We think we have everything we need there. Customers are embracing it-
Mm-hmm
... already.
Mm-hmm.
Payers, less so yet. But if guidelines are adopted, we will be there for our customers who have an expectation to have carrier screening tests that is in guidelines. Similarly, for FirstGene-
Mm-hmm
... which we think will be a real accelerator of growth for us, you know, we're going through clinical validation now. We're not running the studies until we know what's in guidelines.
Fair enough.
But we're geared up to do that as soon as that happens, and very excited to launch. You know, FirstGene is a pretty compelling, you know, product that offers both carrier screening and NIPS testing.
So Paul, on that question, actually, how do you plan to price FirstGene? Talk to us about the benefit from a payer perspective. On the one hand, you know, it'll be cheaper than paying for a NIPT plus carrier on a standalone basis from a payer perspective. But on the other hand, you might see carrier screening sort of volume spike as well, given that you don't need a sample from dad.
Yeah, I mean, again, I think in terms of the important mission here-
Mm-hmm
... is only 50% of carrier screening gets done because dad doesn't come in for a blood draw.
Mm-hmm.
FirstGene, we'll be able to do it on a maternal blood draw.
Mm-hmm.
We'll be able to do it in the turnaround times that our customers are used to, and I think for the payers, you know, I expect us to be fairly novel and aggressive in going to them with a value proposition that they get, what's in guidelines, what patients should be getting, and that we can do it at a pretty competitive price point.
Mm-hmm.
So I'm hoping to flip the tables on this, and partner with payers on what they should be doing at a price point that they will find more compelling than the code stacking or getting multiple bills for multiple products.
Got it. Switching to Precise Tumor and the competitive landscape there, Paul, how do you view your positioning in that market? And are you starting to see any early evidence of cross-selling with MyChoice and MyRisk?
We are. We came out of ASCO with a fair amount of excitement on the pairing of MyRisk-
Mm-hmm
Our hereditary cancer product, with Precise Tumor, and certainly for oncologists treating ovarian patients where MyChoice HRD is, is the gold standard and the only place to go. We see more opportunities in Japan, quite frankly, for MyChoice. We'll be talking about that in the future. Japan's a great market for us. Fortunately, the yen has turned, so that's no longer a headwind and maybe a little bit of a tailwind, but a great deal of excitement, and we had one large customer, I think I commented on, that came to us at ASCO and said, "Look, if..." They have their own EMR, "If we build a bridge so that they can order MyRisk and Precise Tumor," and that's gonna be effective January one.
Mm-hmm.
Their 80 oncologists who were calling for this, out of their 400 oncologists, want to do this, and so that is really the biggest strategic thing I see in our future.
Mm-hmm
Is the ability to give oncologists the two or three tools they need for diagnostic, treatment, selection. You know, Precise Liquid will follow, Precise MRD will follow-
Mm-hmm
... with a single source.
Mm-hmm.
Not having to send tissue samples to multiple labs.
Mm-hmm.
where any discordance in the results can be reconciled by us. So fast turnaround times, easy-to-understand reporting, a place where they can get the multiple tests for the cancer indications that they need. That's, over the next two or three years, what we think can really help us gain share.
Mm-hmm
and have a competitive advantage.
Got it, and what's the latest on Precise Liquid timelines? I think they got delayed a little bit to late 2025, early 2026.
Yeah, they got delayed. MolDX had commentary for us-
Mm-hmm
We're in the process of moving IPG into the lab here in Q4.
Mm-hmm. Mm-hmm.
And we're trying to complete those moves and make sure that Precise Tumor continues to succeed. Because right now, the demand is for Precise Tumor.
Mm-hmm.
And so, you know, we just sort of had to prioritize the work, but that work will accelerate in Q1, and again, we think Precise Liquid will come behind pretty quickly. And we met with MolDX, and we have a path to, you know, respond to some of their questions they had on Precise Liquid.
Got it. Switching to MRD, I think you're targeting an RUO launch by year-end 2024. Is that still on track? And in terms of that first half 2026 timeframe for the clinical launch, is there any sort of possibility of pulling that forward a little bit? I know you recently announced a cross-licensing agreement with Personalis as well. Just talk to us about state of play there in terms of not just the RUO launch, but also the path to clinic.
Yeah. We hope to have some preliminary study readouts here this fall.
Mm-hmm.
We've got a great collaboration with MD Anderson and Memorial Sloan Kettering, with Japan Institute. We have a number of different things in the works.
Mm-hmm.
When they actually read out, all the analytical validation work is coming out really strong.
Mm-hmm.
We'll announce here in the next day or two, the date of our Investor Day-
Mm-hmm
which will really be focused on science and sharing the
Mm-hmm
... the data that we have on MRD, as well as some of our other products. So we'll have more to talk about then. Believe me, anything we can do to move things forward, we're gonna do, but we need to have the two or three studies that MolDX has suggested to us that they wanna see.
Mm-hmm.
And, you know, the trick in this industry, as I've learned painfully, is you don't wanna be too far behind, but you don't wanna be too far ahead either. And, so clinical utility is still not proven for MRD.
Mm-hmm.
Lots of people are ordering it. It's great. It's a very exciting technology. But I was with two cancer institutes a couple of weeks ago. They say their docs are ordering it, and they have no idea what they're doing with it.
Hmm.
I think it's really important for the industry, for this great opportunity for patients, to kind of catch up on what MRD is gonna mean in clinic?
Mm-hmm.
How is it gonna guide treatment decisions? You know, particularly if you're gonna deescalate care or in cases where you think the care is not there, escalate-
Mm-hmm
... chemo treatments, we really need to know how this thing's gonna work.
Mm-hmm.
Payers are really gonna wanna know that.
Mm-hmm.
A lot of interest for our highly ultrasensitive tests, like the Personalis test from-
Mm-hmm
... from payers. We do think the tumor-informed approach with whole genome sequencing for low shedding cancers like breast and prostate, where we're kind of focused, is gonna make a difference. We understand that we're a fast follower to one of our competitors. They've done a great job. We're gonna, you know, dovetail on much of the work that they've done and not spend $500 million to do it, and we think that that'll be a great return for our shareholders.
Got it. Two more quick ones in the portfolio, and then I wanna switch to the long-term target.
Yeah.
So are you still on track to launch a post-RP version of your Prolaris assay in 2025? And how do you see that offering expanding you know the opportunity for you there?
Yeah, we've got a number of different things we're working on for Prolaris. It continues to do well-
Mm-hmm.
but it is clearly a product that we inherited, where the cupboard was... We were not doing enough work in terms of clinical validation studies to get it to level one.
Mm-hmm.
and similarly, to do post-RP.
Mm-hmm.
Those are still things that we're working on. We're also looking at, you know, some other more innovative technologies in the AI front-
Mm-hmm
- and in terms of how to position Prolaris.
Mm-hmm.
We've had some leadership changes in the sales force there, 'cause we were, you know, not executing as well as-
Mm-hmm
- as I think we could have. But there's more work to be done with respect to Prolaris.
Got it.
So-
And, on that, through the AI front-
In the meantime, it's approaching $100 million.
Right.
It makes a lot of money.
Right.
I mean, if that matters for anybody, so.
On that AI comment, Paul, is what you're referring to essentially like an imaging-based approach?
There's a number of novel technologies, and we're talking to a number of different companies that, you know, can really change pathology.
Mm-hmm.
It has implications for things like Prolaris.
Mm-hmm
and potentially other things.
Mm-hmm.
While we're not an AI company.
Mm-hmm
Whether it's in rev cycle, lab operations, customer service, you know, we have a whole team working on what are the real opportunities for AI. And, and certainly, in the pathology space, there's a lot of innovative things going on, and we're having some really interesting discussions with a number of private companies.
Mm-hmm
to see if there's some work to do together.
Got it. All right, so on the long-term revenue growth target, you bumped it to 12%. I think the street's only giving you sort of partial credit for it at this stage.
Yeah, off of a 15% quarter.
Right.
But, you know, who's counting?
You've taken a portfolio view of that growth target rather than sort of the, you know, get to the underlying drivers, right? But to, like, make it a little bit more believable, can you just lay out your assumptions for the increase at franchise level? I mean, you talked about HCT pricing, you know, flipping to, you know, 0% to 2% growth and so on. But as you think about, you know, women's health, oncology, GeneSight, any guardrails around those?
Yeah, I think we have multiple levers to get there. So 10% volume growth and 2% ASP growth gets you to 12%.
Mm-hmm.
12% volume growth and 2% ASP growth gets you to 14%.
Right.
You know, that's what we're aiming for. So we have a high confidence in the 14.
Mm-hmm.
That whether it's flat ASP or 12% volume growth, or you look at what we have done over the last two years, and the momentum we have in the business across our products, and still the work that we've done on some of the things that have underperformed, like our international operations. We're highly confident there are a number of different levers to get there.
Mm-hmm.
13% year to date, 11% growth last year, and I guess the market has us at, like, 9.6% right now.
Mm-hmm.
I think we're gonna be demonstrating why 12% is a highly achievable number. And if you look at what's happening across our portfolio, hereditary cancer, GeneSight, the progress we're making in Precise Tumor, everything that's happened in women's health the last two quarters-
Mm-hmm
... Unlike some of our competitors, we have multiple ways to get there, and we're doing it in a very disciplined way.
Got it. Does that 12% bake in an uplift from guideline changes and the MRD and liquid launch, or would all those three be upside?
The path of mid-teens-
Mm-hmm
- is guideline expansions, new product launches.
Mm-hmm.
When we talk about 12%, it's continued commercial execution, market penetration, win shares-
Mm-hmm
ASP growth in the core products you see today.
Got it. Fair enough. What does that mean for that, operating income guide of around 10%, Paul? I mean, presumably, there's more leverage now if you're growing faster, so.
Yeah, it was a little early to get all the way down the P& L, but, you know, we have demonstrated through all the transformation initiatives and all the inflationary pressures-
Mm-hmm
the ability to maintain and build on 70% gross margins.
Mm-hmm.
We're managing our OpEx and R&D investments, you know, pretty judiciously.
Mm-hmm.
You've seen that for the last, you know, six quarters. But in order to be successful with the MRD launch, in order to be successful in improving clinical utility studies and clinical validity for all of our products, I would expect to see an increase in R&D spend, and similarly, an increase in IT expense to further integrate with our customers through EMR. Not $300 million-
Mm-hmm
but where I think you'll see double-digit growth in those cost centers, and you'll see our OpEx, you know, probably grow 6.5 , maybe 7% all in. Which still means, to your point, you know, 12% top-line growth, 70%+ gross margins-
Mm-hmm
particularly as we come out of Lab of the Future. Right now, we're running a lot of redundant costs-
Mm-hmm
- with multiple labs.
Mm-hmm.
Until we get all that done. You know, we're, we certainly think we can do better than the 70 and, you know, 70.5, 71, 72 over time. So even with a 6% OpEx growth, that EBITDA growth is gonna accelerate, and the EPS will grow as well. And so we think that's-
Got it
the path for the next couple of years, so.
Perfect.
Thank you.
That's a great place to leave it at, and we look forward to hearing more from you at the Investor Day on Precise MRD and the rest of the portfolio.
Yeah. Great. Thank you. Appreciate it.
Yeah, of course. Thanks-
It's early morning for everyone this morning. Thank you.