Hello everyone. I am Subbu Nambi. I lead the Life Sciences Tools and Diagnostics team at Guggenheim. Thank you for joining us today for our inaugural Healthcare Innovation Conference. It is my pleasure to be hosting Myriad Genetics. Joining us is Paul Diaz, CEO. Thank you for being here, Paul.
Thank you.
Paul, opening remarks coming off of 3Q earnings. What is your reaction to the quarter, your progress overall so far in 2024, and what reactions from the community have you seen after your results?
GeneSight and UHC notwithstanding, let's put that to the side for a second. Really pleased at our year-to-date results and how hard the team continues to work. You know, we are still just beginning to get the benefits of our transformation initiatives, but really pleased of how we are growing organically, upgrading our lab capabilities. As we talked about our Investor Day, enhancing our current product portfolio and advancing our new products. You know, a lot to be excited about. There's some particular things I'm sure we'll talk about, but yeah, pleased with our year-to-date results and that we've been staying ahead of and raising guidance along the way.
Perfect. Across commercial tests, one of the themes you touched on at the Investor Day was the cross-selling opportunities for your test portfolio. How are you thinking about it strategically, about these different opportunities, and how much of it matters for your longer-term guidance of 12% CAGR?
Yeah, I definitely, you know, we're excited. I mean, I think the industry will continue to evolve. We're seeing obviously a lot of change. And in order for us to get to the size and scale, to reach more patients and continue to invest in innovation and new products, I think we have to think about what do the commercial engines look like? And when you look at other spaces in healthcare that I've been involved with over many years, the ability to have a portfolio of women's health products, a portfolio of oncology products that solve to the different points of treatment selection and monitoring.
So when you think about oncology, for example, MyRisk, our leading hereditary cancer product, pairing that with Precise Tumor, pairing that with MRD in the future are really the three primary things that a community oncologist is going to reach for when they think about taking care of a breast cancer patient. And so that's kind of how we see it. Now, the leverage there, whether it's in the lab or in the commercial team or in medical affairs, is that the training the same teams to sell a comprehensive set of solutions to a community oncologist, because they don't want to talk to 10 different salespeople either. So that's the opportunity we see there. And we see it from across from Prolaris to MyRisk, and we see it really across the entire portfolio.
Of the oncology platform.
Women's health as well. I mean, one of the biggest opportunities we have, and one of the things that we're most excited about is our breast cancer risk assessment program. That is all about reaching unaffected women, one of eight of which are going to get breast cancer and getting ahead of breast cancer and thinking about things like breast density and pairing MyRisk with mammograms. That's a huge opportunity in the women's health channel, just like things in the urology channel as well.
Got it. We are going to discuss pharmacogenomics for five minutes, and I promise this is going to be my only one question on the United update. First, on GeneSight, the latest news that United issued the decision to remove coverage in 2025 has been top of mind for investors. But as you said, you disagreed with the premise of policy change and will work with them to try and find a solution. Could you provide us some additional color on your expectation for GeneSight into 2025 after this announcement and your plans to engage with them?
Okay, let me try to clarify some points there. So this isn't a coverage decision. It's a policy decision. So United issued a broad policy regarding pharmacogenomic tests. We believe that GeneSight, quite frankly, is quite differentiated from all the other pharmacogenomic tests in the marketplace. But if you look at the policy, it breaks down into different pieces. So I want to spend a minute or two kind of going through this. First, and importantly, is the clinical evidence. And again, we're not questioning anybody's motives, the authors. It's just we look forward to sitting down with United and on the clinical evidence, sharing some additional clinical evidence that was not taken into account. We have a meta-analysis for GeneSight, solely GeneSight, that we hope to be published next year. We think that's important.
We have data and work that's been done by Optum Genomics that talks about clinical utility of GeneSight. We think that's important to take into account. The second piece that's really important here is when you look at the report, you think about guidelines. And so there was a misinterpretation and recently, I mean, just recently, a clarification from the American Psychiatric Association regarding the report that was cited. And the report that was cited was a report, not a guideline. And so there's been a clarification that has been published to that effect, where a work group offered a study, a report, not a guideline. And so that's a piece of clarification that we're going to be talking with United about.
And the APA has already made clear and went as far as to say that the study, that the report that they were referring to does not represent the APA's policy position or guideline. And so that's very important as United considers whether or not GeneSight should be excluded from that policy. So that is the beginning of the dialogue with United. We're looking forward to, again, sharing additional clinical evidence and helping them see the clarification that the APA has made that they did not issue a guideline. What they issued was a work group's report, and those are very different things.
So do they have a guideline?
They do not have a guideline.
What about these other clinical pharmacogenomic implementation consortium guidelines and International Society of Psychiatric Genetics guidelines? You know, all the different guidelines that.
We were going to spend five minutes on this, so I think what I want to make sure that investors understand is United, again, which is their right, and not question the intention of folks who are updating a policy. We think the policy missed certain important clinical evidence, and there was a misinterpretation of the APA's report from a work group, which is different than a guideline, and I don't know how much United relied on that, but it was definitely part of their policy change. So we're looking forward to sitting down with them and really getting into the details around the compelling value proposition that GeneSight is for patients. We hope to serve 500,000 patients this year struggling with mental health, many of which struggle with the trial and error of getting on the right medications, and that's what GeneSight does.
GeneSight is not a panacea to solving mental health, but for anybody who's experienced mental health issues in their families, getting people on the right drugs faster is the first step to recovery, and that's part of the problem, and GeneSight is solely a tool. It does not tell a provider which drug to choose. It tells you which drugs you may have an adverse reaction to. It tells you which drugs we think will work better for you at which dosage, which allows a patient to begin their treatment and recovery process, and we think that's important, and Optum Genomics thinks that's important, so we're going to work a little bit to get the different parts of the house to talk to each other and see where we come out on all this.
Thank you for that color, Paul. As promised, I'm moving on to oncology. Turning attention to oncology, starting with Prolaris. At Investor Day, you did say Prolaris is profitable, but the growth has been flat. Why has it been flat, and what can you do to reinvigorate growth for this franchise?
The Veracyte folks here have done a really good job. They were here right before us, and they've done a really good job with the clinical evidence. Remember, they're post-RP, and we're more focused on at the time of biopsy. We sort of compete and overlap with different channels. But we are certainly working to advance the clinical evidence of Prolaris to get it to Simon level 1. It's gone a little slower than we would have thought in terms of acquiring samples and advancing our clinical studies, but that work continues. I would say in the short run, we're beefing up our medical affairs team and have hired a new vice president of sales to refresh our go-to-market and make a stronger, more compelling case for Prolaris, which I think is there. We think we'll see some recovery in Prolaris growth.
We have very strong ASPs there, very low no-pays, really great product for patients. The principal is in urology channel. And so we are number two in the market, and we're going to work to be a stronger number two here. But that's clearly a product that fits within our oncology portfolio.
Perfect. Hereditary cancer. At Investor Day, you said you hope to continue with double-digit volume growth and ASP. Could you break down that growth for us between the affected and unaffected population?
Yeah, it moves around a little bit quarter to quarter because of the way the channels operate and stuff. But the biggest opportunity is in the unaffected that I was talking about just earlier. Really excited about the traction we're getting with our breast cancer risk assessment program, which is primarily focused on unaffected patients in multiple channels, including the urology channel, again, pairing that with Prolaris. So you know there we see less competition. And there is the challenge in an OB-GYN office that you have different people focusing on prenatal versus other women's health issues. But we're working through that. Again, that's part of that cross-selling. But the penetration for hereditary cancer testing for unaffected patients is only 15%.
Again, with guidelines expanding for breast cancer screening, the opportunities we have to work with hospital systems and imaging centers and others, we're really excited about the double-digit growth there. On the heredity side, we have the best hereditary cancer product in the marketplace, period. That's one thing that I can say with all confidence. We pair that with RiskScore, our PRS test that we've just gone and presented six abstracts on. So increasingly, RiskScore we think is a differentiator. And there we're winning back share. That's where Invitae, now Ambry, and market share that we lost over the years, we are winning back because of the quality of our test, the quality of our report, and quite frankly, a better commercial go-to-market. So I think we expect to see 8%-10% growth in both of those channels over the next couple of years.
8%- 10% in both affected and unaffected. Turning to NIPD and maternal health portfolio, you can now perform Prequel test as early as eight weeks, a week sooner than competing tests today. Have you seen?
Two to three weeks sooner, really.
Two to three.
Because the big lie out there is that there's a huge failure rate for many NIPS tests. And so when you ask somebody, a woman to have to go do a second blood draw, and that takes another two or three days, that matters. We have the lowest failure rate and the highest accuracy with a Prequel with Amplify. Now, in a country where knowing your reproductive status matters more than ever, eight weeks matters a lot more than 10 or 12. Having a highly accurate test that helps you make decisions as a family, I think really matters. We're very excited about, quite frankly, that's what we're about, solving the problems of patients in American healthcare. FirstGene, we'll talk about that in a minute.
So yeah, I think being able to give families answers more quickly and accurately gives us a competitive advantage as we go into next year with Prequel.
Have you seen market respond that way?
But we haven't launched it yet.
No, like the customer focus group.
When I talk to people and we talk to focus groups, yeah, people are excited to have the results in eight weeks and know that it's going to be a first pass, right? That it's not going to be, oh, I got to draw blood a second time to get the result. Again, pretty high failure rate with some of our competitors, which nobody really talks about. So excited about that. We'll see what happens with guidelines, with microdeletions and 22q. We're continuing not to hold our breath on guidelines, but I will say that with respect to carrier screening, which maybe we're going to get to, we're already starting to see coverage expansions. We had a laboratory benefit manager recently announce expanded coverage. We've had two commercial plans now in the last 30 days expand. So I actually feel much better about launching Foresight Universal Plus.
I was worried that we were going to be six to 12 months away from getting paid, but those gaps are starting to close, and I think when guidelines are issued, I'm a little bit more optimistic that the time between guidelines being expanded and payers covering it may not be the year, two years that it often has been.
Oh, you're already getting paid on the expanded panel?
We are starting to get paid increasingly. We've got three commercial payers that have agreed to start paying for Foresight Universal Plus. So we'll see continued improvement in ASP there.
That's fantastic. The SneakPeek was launched today or the press release today. Tell us a little bit more about the market opportunity here. It is unlike anything that Myriad has done.
SneakPeek is pretty cool. And again, what we're trying to do is connect with women early in the journey. And fetal sex testing, to the politically correct gender reveal, is very popular in a lot of families. And having the SneakPeek test up on the shelf at Walgreens and CVS and now Walmart and principally our e-commerce channel begins that process early. And so the cross-sell there is once you know that you're pregnant and after you've gotten a sense of what the fetal sex of your child is, people start thinking about the health of their child. And so that's where hopefully FirstGene, Prequel, all come into play. And it's all about connecting with women earlier in the journey and families earlier.
And if we make that connection a good experience, then the next thing they're talking about and thinking about is, well, my aunt has breast cancer. What's my risk for breast cancer? And, being there with our MyRisk Hereditary Cancer testing. So what we're trying to do is create, again, a more comprehensive set of offerings for oncology patients and women's health, which I think are way underserved, quite frankly.
You've spoken about, partially spoke about the FirstGene. This is going to be a highest gross margin product, right? 30%-40% higher than Prequel or Foresight alone. While we know this is an estimate, could you walk us through what the estimated math was that you used to bridge between the current gross margin and the estimated gross margin benefit?
Yeah, assuming that over time we can make the compelling case to payers, which I think we can. Just refresh everybody's recollection. I was at a panel the other day with women's health. People were talking about blood compatibility issues. They were talking about prenatal testing, carrier screening testing. FirstGene solves to all of that, and we don't have to chase dad down for a blood draw to get the answers there, so 50% of carrier screening testing does not happen because you can't get a blood draw from dad. So access really matters, right? And so that's one of the big appeals. Our hope is to go to payers early, including United, and say, look, we're going to solve to all four of these issues. We're not going to bill you twice for a carrier screening and NIPS test.
Because the COGS are relatively the same for us to run this, I'll give it to you as a discount, but you got to pay me. You got to agree to pay me upfront. It's a crazy way to think about actually doing diagnostics in this sector, but I think it's the way we should be doing diagnostics. We should be creating a value proposition and going to market with line of sight on payment, not getting MolDX and then praying that five years later commercial payers will follow.
Have you had any initial reception to that idea?
Yeah. I mean, I think access, the ability to bring those four answers to a woman in that journey, to be able to do it at a lower price point than getting paid twice, that seems pretty compelling. And as we complete the clinical validation studies for FirstGene in Q1 of this coming year, we're going to be sitting down with payers right away and making that case to them.
Perfect. For the last five minutes, I want to touch on Precise MRD. You recently received your third patent for Precise MRD, and the RUO version of the test is available to research partners. Could you walk us through the steps that are needed between now and the ramp to 2026? What are the things that need to be done?
Importantly, we're running MRD in our labs today. So we're running it for several pharma partners already. That's going to ramp up even further. We're running it on a couple of different systems to keep a competitive edge there. Oops. Sorry about that. So we are trying to figure out how to operationalize this. We're running it on Ultima machine. We're going to be running it on X Plus. And we're going to see who gives us the best results there. And we're running it for pharma. And the feedback there and the feedback from the studies with the Institute of Japan and MD Anderson have been quite positive. We'll probably have the first readout of a study in February. And we expect to have two or three studies by ASCO next spring, June, and submit to MolDX.
We believe that we can be a fast follower given the trailblazing work of Natera here, quite frankly, and hats off to them and their success. But we're happy to be a fast follower because we're going to have a more sensitive, more highly accurate, and less expensive test that we're going to manage out of our own labs, and we're going to have part of that market. It's a big market. It's a big opportunity for patients, so we don't think it's a first-come, win-it-all kind of view of the world, which is their view, I think, so we're excited about that, and that puts us in a position to have a commercial launch in early 2026. And I think the bigger issue, quite frankly, longer term is beyond MolDX.
We have very little clinical utility evidence to determine how MRD is really going to change practice patterns, how we're going to de-escalate care, escalate care, when to use it, how often to use it. We are very early in the innings here. When we talk to Dr. Langer at UHC and we talk to other academic medical centers, they're like, wow, this is a really cool toy, but we have no idea what we're going to do with this thing yet. So I think it's going to be quite the journey here. Like most things in American healthcare, it takes seven to 10 years for full adoption to happen.
So I think it's going to take a while before MRD is fully integrated into treatment practices and before people start not doing other kinds of diagnostics or de-escalating care for somebody, which they're just not going to do unless they're absolutely sure that the cancer is fully in remission. I mean, I know that's what I would do if some of my family members had cancer.
We heard just that this morning, actually, for our panel, that treatment escalation is one thing, but treatment de-escalation, you absolutely need like 100%.
And we're not going to get the savings unless we can tell a patient, you're not going to need to get two more chemo treatments. You're not going to need to go back in every two months to get another diagnostic test that's invasive. And so there's great promise for patients and the healthcare system around MRD, but it's early days. And again, we think that particularly for low-shedding tumors like prostate and breast, a higher sensitivity MRD is going to really matter. So we're quite excited about Precise MRD, and we're going to be thrilled to bring it to market in 2026.
Awesome. Three years from now, with one minute left, what will investors wish they realized about Myriad Genetics today?
You know that the team over the last almost five years has really rebuilt this company from the ground up. I mean, the foundations of the company were quite great in science, but we have really worked very hard from the minute we interact with a patient or a physician to how we sample collect, how we run samples through the lab, and how we're doing this whole process for the decade to come. And that we're going to have foundationally all those pieces in a way that I think the rest of the industry will need to do. And so we expect to be a leader in oncology and women's health with respect to advanced diagnostics.
Perfect. With that, Paul, thank you so much for joining. Thank you all for joining.