Myriad Genetics, Inc. (MYGN) Earnings Call Transcript & Summary

August 11, 2022

NASDAQ US Health Care Biotechnology investor_day 113 min

Earnings Call Speaker Segments

Paul Diaz

executive
#1

Good morning. Welcome to Myriad Genetics Investor Day. Really pleased for you to join us today, and we're very excited to have you and give you an update on the company and the great work that everyone's been doing. If we could just adjust the volume down, please. I'll just whisper. Anyway, great to have you all here this morning. We are more excited than ever about the opportunity we see to advance our mission to empower healthcare providers and patients with important medical information to better detect, treat and prevent disease and make precision medicine available to all patients regardless of race, ethnicity or economic background. The evolution of our healthcare system towards a more consumer-centric model where patients and family engagement drive outcomes is accelerating, value-based care, models that are physician-driven, and relying on coordinated care and informed patient engagement are becoming the norm throughout our healthcare system. And we see a growing interest and adoption by patients, payers and health care providers in digital and precision medicine tools to personalize care. This demand and opportunity has only been accelerated by the pandemic. And more than ever, patients want to be informed and strongly desire to be actively managing their own well-being and the healthcare services provided to them. That engagement is all about trust, and reputation. And at Myriad Genetics, we are singularly focused on building reliability and trust with our customers at a time where much of our industry is under significant operating and financial pressure. We see trust as being built on our core values: collaboration, inclusion, simplification, innovation and caring. With the goal of offering our provider partners and their patients, the highest quality products, exceptional service and ease of use and affordability. Over the past 24 months, we've worked intently to listen to our customers who have universally told us that we have opportunities to improve access to our products, and we can more effectively do business with them. You'll see in the presentations today, our significant efforts to meet this demand and opportunity. At a time, we also see increasing demand for innovation and acceleration of many home-based digital models, and engagement, including sample collection at home. Our industry is just beginning to execute and scale to the commercial and patient opportunity that the science affords patients and our healthcare partners. And we see a unique opportunity for Myriad Genetics to gain market leadership again given the dynamics of the market and the low penetration we see in the addressable market for many of our products. I firmly believe that we are still at the early stages of adoption of genetic testing. And even with products like our hereditary cancer that there's still a tremendous amount of opportunity to grow. But adoption and success are going to be predicated about finding innovative partnerships in this broader healthcare ecosystem. Inclusion is one of our core values and it extends to the mission to ensure that the medical information and tools we offer healthcare partners is accessible to all patients regardless of race, ethnicity or social economic condition. Risk score for patients of all ancestries, and Prequel and AMPLIFY are good examples of that. We've also been working hard to create greater transparency and improved payment options at the point of care to fulfill this promise. Finally, we are taking concrete steps to improve data sharing to ensure that the deep reservoir of data that we've accumulated over 30 years is available to advance science and innovation for all. As I previously mentioned, our primary focus right now is to improve the customer service experience and take the friction out of doing business with us. We are quickly digging out of our tech deficit and launching new customer-facing tools and portals to support the patient journey and improve the experience of the healthcare providers we do business with. As Kevin will discuss, we've made much of this ground up in the last year and are excited to have him share the technology that we've developed. I won't steal Nicole and Dale's thunder, but we're also excited to showcase the progress that we've made and the plans we have to improve our products and modernize our labs. And as Kevin and Dale will both highlight, we're really excited about the progress we've made on our research and development efforts and the new product launches that we planned for '23 and '24. [Presentation]

Paul Diaz

executive
#2

So you got to love Dr. Monk. You took us a task -- and after many years, we finally listened and started responding with 15 gene expansion from myRisk and other things. So great science and innovation don't change lives unless we can make them accessible. And we've certainly dug out of our tech deficit, and Kevin will talk about that. But we've certainly, over the last year, made a lot of progress, and you're going to see and hear today about the progress we're making on the commercial side, and really changing the way that we approach patients, we approach providers and engage with them in a differentiating way. And we're really excited about the prospects for growth of this new model. And I'm going to have Mark come up and showcase it for you.

Mark Verratti

executive
#3

Thank you, Paul. Good morning, everyone. Wait a second, there we go. Probably have to do the same thing that they did with Paul to turn it down a little bit. I was telling Dave earlier, I've been in the sales and marketing space for over 29 years, sadly to say, in pharmaceuticals as well as in medical device. And I've never been more excited till now, partly because our space is rapidly changing, right? The healthcare industry and the genetics industry, it's no longer just about having the best product or having the best science. Now surprising all of us as consumers, we actually want to know how much it costs. We're challenging why won't we show up every time in the doctor's office. We have to fill out 5 pages of information with the #2 pencil, right? We really want to know where do our results go, why don't we get them online? Why do we have to call the doctors over, right, just simple things. Finally, the health care industry is changing. And it's no longer driven by a single channel outside sales team knocking on doors to try to pass that information along. So I couldn't be more excited to share that with all of you today. So as Paul mentioned, we're just beginning, right? This whole healthcare change, the commercial capabilities change. We've done it within some of our business units. You're going to hear today how we're going to take that in the back half of this year to really accelerate growth in 2023. Looking at the left-hand side, there's 3 key components to that. Number one, as Paul mentioned, is around the Myriad brand, right? There is a new Myriad here, but as many of us know, just because a company creates a new logo and starts to do new things, how do we reach the 60,000 providers over the last 30 years to let them know that we're doing things differently, right? Then we talked about the commercial capabilities. How do we bring those -- they are in 1 business unit that I'll talk about in mental health. How do we take them to the other business units? And then lastly, as you heard our physicians mentioned, they want a better experience. They want it to be easier, faster, quicker. Now we've done some things really, really well. I'm going to talk about those today. The piece that gets me more excited though is about the things that we still have work to do on because otherwise, I won't have any levers as a sale and commercial guy to grow our business. So I'm excited that there's things that we still need to do. right? There are still customers that we need to win back. There are capabilities that we need to do in other business units. You're going to hear from Kevin about the tech debt, and about how we can better integrate with our health systems. So starting with the brand. We're not only saying that, but we want to make sure we could back it up with data. So if you look at the top graph, that we went out back 2 years ago in 2020, and we talked to patients and consumers who understood the Myriad brand as well as all of our competitors. And then we went back, 2 years later, this year in 2022, and we asked them, how do you feel about Myriad today. Do you have a better impression of Myriad today? And as you can see, we grew 10 points, okay? Now that in itself doesn't mean much unless you look at the competitive landscape, where you see, we don't take that for granted, right? None of our competitors have that same gain. And in some cases, some of our competitors actually went down. So the space is changing rapidly. And we're making sure that we're following up, and we're listening to our patients. We also did the same on the physician side. And we asked them several questions. Number one, would you recommend Myriad to your patients? Do you feel like we're a good partner? And overall, what is your perception of us? And as you can see by those pie charts, essentially, everything is up at the right -- everything is going in the right direction. Are we perfect? Absolutely not. Do we still have room to grow? For sure. But I think what we're seeing is a more data-driven of the things that we're doing are we -- can we actually measure and make sure that they're resonating in the space. So let's pivot a little bit to the commercial capabilities that I talked about. I'm sure you've heard from Paul, Bryan, you've seen the GeneSight results. This is the business unit where we started about 18 months ago, really changing the way that we think about reaching consumers. And the main challenge we were trying to face with is how do we reach millions and millions of patients that are struggling with mental illness, especially coming out of the pandemic. And in the primary care space, there's over 1 million providers that are writing antidepressants or that are treating this space. So how do we reach that, that model of having a sales team, and we have an unbelievable sales medical customer service organization that has over 950 people in it broadly, right, over 500 salespeople, They can't reach all those patients. So we need to think about it differently, and I'll get into what that model looks like. The piece that I'll draw your attention to. So last year, year-over-year, 50% growth. This year, we're looking at 35% growth year-over-year. The number I'll draw your attention to is in the middle, the last 5-plus quarters, we have been able to add over 3,000 to 4,000 new providers every single quarter writing GeneSight for the first time, Okay? So the model is working, to be able to reach more and more clinicians, which ultimately means more patients benefit. So let's talk about what that looks like. A little bit of an eye chart, so I'll start all the way over to your left. Again, a very large addressable market. The way we're defining it here is there's roughly 5 million patients who suffer from depression, anxiety or ADHD, who have -- are seeing a clinician, already tried a medication. And unfortunately, that medication didn't work. And I'm sure many of you and many people who know have suffered with that trial and error. So that's how we're defining that 5 million. And so through more of an omnichannel of our marketing, inside sales and outside sales. We've essentially tried to increase the awareness through all of our social media channels, all of our digital marketing channels to drive people to our website. Now that, in a sense, isn't very new, right? I think almost every company out there today has a website. The key though to that website is can we connect a patient or a provider who's interested in our test to actually get it. So imagine all of you sitting here today, you get excited by what we talk about. Imagine if you or you know someone who wants to get one of our tests or any test in the healthcare space, how do you actually get it? It is a challenge. What do you do, do you call your doctor's office and say, hey, do you offer this particular test, right? And hope that they do. With this model, we have an ability through our website to be able to instantly, whether you're a patient or a provider, have someone in our inside sales team immediately reach out to you and talk to you about where do you need -- do you want to give us your physicians information so we can educate your physician, do we need to connect you to a physician? And ultimately, what that lead-gen model allows us to do is, as I mentioned before, that 3,000 to 4,000 physicians per quarter, 80% of them came in through our website, 80% came in through that channel, okay? So great stuff here. If you can't tell, I'm a little excited about that. What I'm mostly excited about is this slide is when we think about our other business units, right, and again, going from left to right, you think about hereditary cancer, right? 29 million unaffected women meet NCCN Guidelines, but only 24% have gotten tested. Go to the next one over when you think about the prenatal space. 3 million to 4 million pregnancies, again, only about 30% are getting tested. Go to the tumor profiling. Almost 1 million patients are diagnosed with cancer, and less than 40% are getting tested. So yes, are we in competitive spaces when you think of these business units? Absolutely. There's a lot of competitors, and we need to fight that out. That's part of the fun, part of the art of sales kind of duking it out against competitors. They also make us better. But the bigger picture here is, how do we reach more people, right? How do we help clinicians identify more patients in an easy way, in an education way to make sure that everyone is getting the treatment that they need. And today, despite the fact that we're not the best we can be, we're helping over 1 million patients a year. I mean that's 1 million patients a year, and we're still figuring it out. So the future is extremely bright. I won't spend too much time on this, but again, Paul mentioned it, you heard our physicians mention about that clinician experience. This is just to say that like many other companies, both in healthcare and without, we've stood up a Net Promoter Score program, we're now real time we're getting real feedback from our clinicians as well as our patients. So we make sure that we're doing the right things, right? Those like when you -- when you fly on Delta and whether you had a good experience or a bad experience, you immediately get that little survey result and says, hey, what do you think? Would you recommend Delta, again? Same type of experience, with a couple of other double-clicks, Okay? What are we hearing from our patients as well as our physicians? Yes, the quality of the test always matters. But the best experience, and I'm sure many of you can relate to this, is when you personally have a good experience. When you not only got good quality of care, but those of you that have to work in the city, I can only imagine what it's like going to NYU or Colombia or Cornell, how long -- how many hours in the day does it take you to get that good quality of care. Imagine if it was delivered in 30 minutes, or if it was delivered in your own home, right, which we've seen over the pandemic. We have the capabilities to do that, and we have the capabilities to measure that as we go along. Kevin is going to talk a little bit about the tech behind this Myriad Complete solution. But what we've seen when we've worked with our providers. And this is an example, and I'll kind of walk you through the sort of the numbers going from 1, 2, 3 on. And talking to our clinicians, and this is an example of a typical OB/GYN office that sees 40 or 50 patients a day. They don't have the time to do the proper screening of, which patients coming in? Do I need to consider hereditary cancer testing on? So we have the ability to Myriad Complete, either in the office or even outside of the office, to help them do all of that prescreening before you get there. And again, all of us have been a part of that of go to an office and not wait. Again, I mentioned the 5-page forms. Imagine if you had to spend another 15 minutes filling out more questionnaires when you could have done it from your own home. From there, it goes to the pre-education test because many of us in this space realize, well, now that I qualify for this, what do I actually qualify for, right? And physicians who are limited on time were finding don't have the time to do that patient education and answer all the questions that we probably have about what does this mean for me? What does it mean for my kids, what do I do next? The next piece of it is, if we get all that piece figured out, how do we do simple ordering. That hopefully is already integrated in their large health system, and they can order it with multiple products. They don't have to go somewhere else. And then the most important question that all of us are starting to ask, surprise, is, well, how much is this cost, which for years, we never really asked that question. But now surprisingly, it'd be really, really nice to know at point of care before I say yes, how much is it going to cost me? And that, as many of you know, is not an easy answer when you think about the way our healthcare insurance works today with high deductible plans, co-pays and everything else. But we have the ability through our patient cost estimate, and you'll hear a little bit more from Kevin on that. Lastly, we're delivering actionable results, and we're doing it in a way that, again, we can educate patients and/or providers and do it in a way where we can actually get those results to the patient in multiple platforms. Not just on a piece of paper anymore, but now digitally through their phone on text or an e-mail. So to sort of close everything out, Myriad has always been that trusted partner. You can see now that we're trying to expand beyond that to the new Myriad brand to a brand that is not only the trusted partner with the best-in-class tests, but also one that's easier to work with, a good partner, to be part of both on the R&D side as well as on the commercial side. You're seeing how we're going to be taking those commercial capabilities that I talked about to our other business units. Kevin is going to talk more about the EMR integration and how we're partnering with larger health systems. And that's important for today, but it's going to be really important after you hear Dale talk about the new products that we're going to have, so that we can bring those products and we can launch them to market in a much better the way that what we've been able to do before, not only the products that we're going to do here at Myriad but also any M&A opportunities that we have along the way. So I hope this was a little inspiring for all of you. I look forward to talking to you afterwards if you have any questions. And on that, I'm going to turn it over to my partner in crime, Nicole. Without falling off the stage.

Nicole Lambert

executive
#4

Thank you, Mark. It's my pleasure today to talk a little bit about our -- how we're operating our business. As you can imagine, over the course of the past couple of years as Myriad did acquisitions as we added new products, it got more and more difficult to get data. We had multiple sources of data. And sometimes our teammates and our people weren't aligned as to where we stood on some of these things. We've put a lot of effort in the last 2 years to getting the data in the right place, getting consistent measures that we can all look at across the entire organization to say, how are we doing on our mission? How are we doing on delivering the customer experience that Mark talked about. So are we sure that we're getting turnaround times fast enough for what physicians need? If we have a pregnant patient that's waiting on a test result, we're doing everything we can to return that result as soon as possible. How are we performing with respect to customer NPS, or the customer experience, customer loyalty? We didn't always have those metrics readily in front of us, and we do now. We've put a lot of effort into discipline and focus, teammate engagement, getting everybody looking at the same scorecard and the same metrics so we know how we're doing in real time, and we can pivot the organization if we need to. If there are places that we're not delivering, we know that right away, we can address that right away. If we get feedback, as Mark talked about in the Net Promoter Score, if we get feedback that we need to do something differently. We can see what those levers are doing today and how we can change them. So I'm excited to give you a little bit of insight as to how we're operating the business and how we're trending on some of the key metrics that we've identified. So a little bit, we've bucketed these metrics into 5 buckets, and there are about 3 metrics in each of these buckets. But really, our philosophy is that it all starts with our people. It all starts with our team. How are we doing at recruiting talent? How are we doing at engaging that talent? Because if we have highly talented people that are motivated and committed, we know that they will deliver a quality product every time and a quality customer experience. That's going to fuel a great customer experience and growth in our test and growth in our business. And then we have to make sure that we can scale that business that we can handle the volume that comes in, and we can still deliver on that great customer experience. And if all of these things come together well, we will deliver on the financial performance that our external stakeholders expect of us, but also we will generate the type of cash flow and the type of revenues that we need to invest in our operations, in our tech, in our R&D and launching new products and making sure that we can continue this mission for the long term. So I'm going to talk through what the metrics are in each of these buckets and how we're trending. So the one on the left, we're very excited about in terms of employee turnover. If we think back about 2 years ago as we had some disruptions in our industry as we went through transitions, we were at the place where our sales team even was turning over. About 1/3 of our sales team turned over consistently, and it's very difficult to grow business when a customer sees a different sales rep all the time, and they don't have that relationship, they don't know who to call if they have a problem or if they need something from Myriad. We've stabilized this quite a bit. If you look at our Women's Health sales force, there was a 30% turnover a year ago, we're down in single digits today. And that makes a huge difference to our customers and the perception of us in the marketplace. So this is a really important metric for us. The people that we have had at Myriad that have stayed at Myriad through transitions, through difficult times. They are here to stay. They've come through the pandemic, and they're engaged. We just got our most recent round of employee engagement feedback, and there was a significant upward trend in our employees, understanding our message, wanting to be a part of it, living our values: being caring, being inclusive, being committed. They're here to stay, and we're excited about that. Diversity and inclusiveness was an initiative for us that we wanted to continuously monitor how our employee base look. Is it representative of what our customers look like? And can we be proud of the diversity that we have at all levels, getting up to the top levels of our organization, and that also is trending upwards. Turnaround time. So this is critical for us, especially if you think about things like a breast surgeon that is trying to make a decision about unilateral or bilateral mastectomy, or a medical oncologist that has an ovarian cancer patient in front of them. Stage IV, they don't have many treatment options. They need to know which treatment option to use as soon as possible. So turnaround time is critical for us. We've always been good at this, but we continue to look for ways to do better. And we intentionally put this as total turnaround time, not just laboratory turnaround time. So everything that the customer would experience, whether that is the time it takes for us to get a pre-off, the time it takes for us to run that in the lab, the time to troubleshoot if we don't think there's something going on in the lab that we're not sure about. Everything from start to finish, what the customer would experience, we're going to measure it that way so that we have an understanding of how the customer experience is with us when they send us a test. NPS, as Mark mentioned, is a new metric for us. This was a baseline. We're excited about 72%. That's much higher than a lot of what we would see across our industry and other industries. So we're excited with the baseline that we've gotten. But we know that we need to continue to measure that, right? As our industry changes, as competitors do things differently, as customer expectations change. We need to always get that feedback to understand how we're doing or what is it that the customer wants differently, and we need to be able to pivot to that. And then audit findings. These are internal audits. So we continue to challenge ourselves from a quality insurance perspective. Do we know that our products are always performing to spec. Or if there's something that we find that doesn't look right, we catch that, we flag that, we address that right away. We actually kind of like that 1 to be steady because we want to make sure that we are reporting and identifying patient -- problems as well as resolving them. We don't want to discourage anyone from reporting a problem if they find it. And then we also want to make sure that we continue to investigate those and resolve it. So there's a certain amount of those audits that we want to make sure we're constantly improving in our laboratories. So growth trends, active customers. As Mark mentioned, a lot of the efforts that he is doing with respect to digital outreach, with respect to our sales team visiting customers, we continue to add new physicians every quarter. Every quarter, there are more and more physicians that are ordering from Myriad. Those might be new physicians that have never ordered a genetic test before or those -- they might be physicians that are ordering from a competitor or have ordered from a competitor and have decided to give Myriad a try. So the number of physicians that are coming back to us or coming to us is always improving as our reputation in the marketplace improves, more and more physicians are voting with their feet and giving Myriad a try. The volume trends are in yellow. They are improving 12% year-over-year, but this is a place where we know we can do better. And that's part of our partnership, Mark and I to understand for these physicians that have given us a try. What do we need to do every single day to earn their loyalty, and their continued business, more of their business? And that's something that we continue to look at. We get their feedback. We make improvements. We continue to look at. The customer that ordered last quarter, did they order again this quarter? Did they order more this quarter? We're watching that actively and making sure that we're responding. And then average selling price. This is something there's a lot of downward pressure in our industry on ASP, and we have been able to hold steady and some of our product lines are continuing to improve. As guidelines improve, as coverage improves, we've seen ASP hold steady, or improve. And then all of that comes together for the right financial picture. We're operating the business effectively and efficiently. You will see the financials that we need to continue our business goals. And Brian will talk a little bit more detail about the financials later. But one of the most important things for me and one of my focuses going forward is taking some of this revenue and investing into improving our operations and our ability of our laboratory to continue to serve our patients. So I'm going to talk next a little bit about our laboratory in the future. So in order to support this growth and productivity and innovation, I want to show you what some of our new laboratories look like. This is a picture of our building in Salt Lake City, our new Myriad West campus. We recently invested in our headquarter service center in Salt Lake City. It's been an amazing opportunity for our teammates to come together. It's motivating and inspiring for everyone to come in and see how the laboratory works. And also this new building will give us the opportunity to have a wide footprint. Right now, we've sort of got our labs shoehorned into different buildings in an academic medical center where we were born. This gives us the opportunity to broaden out our footprint, to scale and to make our laboratories most efficient. So we will be upgrading our real estate in Mason, Ohio and our production facility in Cologne. And we'll be moving to new laboratories, new real estate in both Salt Lake City and South San Francisco. This will be the building that houses our main production laboratory, high throughput capacity in Salt Lake City. So let's take a look. [Presentation]

Nicole Lambert

executive
#5

Very good. So we're excited to move into that new laboratory. I think historically, there were places that we had under-invested in our laboratory, similar to the way that we had in tech. And this really is going to align our tech capabilities and what Kevin has built on his team with new platforms, upgrades to our current processes as well as the people strategy that aligns to the people that we need in each of our locations to run this process effectively. So really, this is a multi-pillared approach to solving this problem that. We talk a lot about the real estate, and we will move into more modernized facilities. But really, this gives us an opportunity to enhance our current processes our current test more lean and efficient, save on COGS as well as innovation. This will allow us to launch new tests faster. And Dale will talk about some of the new tests that we'll be launching soon. This allows us to move from a research environment to a high throughput production environment very, very quickly to grow and scale as fast as the market demands for these new products. And then really scaling for growth, the automation, as Helen said, allows us to increase capacity dramatically. So basically, for every line of production that we convert our current methodology to the new automated methodology, we get about a doubling of capacity, of how many samples we can throughput those labs. And they are, as Kevin mentioned, very efficient, very small footprint. So if we need additional production capacity, it's easy to add another cell or another line of production. So we're confident that we can scale for our future needs. A little bit -- I'll give you a little bit of an overview of the time line. Essentially, in the next 2 to 3 years, we are putting in an $80 million investment. That will include enhancements and upgrades to our facilities, getting our new laboratories ready to occupy and building the automation, you can see across the entire time line. We will transition into our new laboratories mid-2023, and once we transition into the new laboratories and our new way of doing business, we will save about $12 million annually in production costs as well as some reductions in real estate costs as well, and then that will allow us, again, to launch new products into that line, into that production facility very, very quickly. And with that, I will turn it over to Kevin.

Kevin Haas

executive
#6

Excellent. Thanks, Nicole. So really excited to come speak with everyone today. I think Mark talked earlier in his session about what we've been doing to improve the customer experience and to drive growth. Now I want to talk about all the technology behind the scenes that goes into powering that and making that possible. First, I just want to reflect on the journey we've been through as a company. It is really has been as much as a Myriad transition as a technology transformation. Our goal is to create this best-in-class platform. This precision medicine apparatus that can serve millions of patients. But the reality is this technology was an area of Myriad that we had under-invested in. We had some great tech that we picked up from our acquisitions in Mason, Ohio and from South San Francisco. But what we wanted to do is we needed to bring that so it is a homogenous experience for all of our different product lines. And essentially, a lot of the core systems at Myriad have reflected both the expertise of the 20 years that we've been running those products, but also the cost, the complexity, the technical debt that we had acquired. And so what was essential as we make a major investment in overhauling these core systems. And so about 2 years ago, we embarked on about a 40% increase, both in resources, people power, the team size, what it took in order to make this major technology advancement. And in order to do that, we've worked hard with the team, and we're just now starting to roll out some of these key commercial capabilities. We've had things like risk score fall ancestries, a new precise tumor launch with a new integrated electronic portal. We had new pricing options and gene expansions. And so just at the beginning of this year, this first half of the year, we're really seeing an increase in the velocity of these major capabilities, probably the most productive time we've ever had in the history of Myriad. And I think what's important to note is this all these investment has been made while still maintaining the overall OpEx picture of the company. These are resources, these are reprioritizations that we've made in order to be essential that we deliver on the core capabilities to drive growth. And I think what we're -- within we're just going to talk about a little later in the presentation is just how we're now doubling down on these capacities. What are the things that we're going to be able to do are the winning strategies that we've seen in these different markets in either GeneSight or prenatal or Women's Health or Oncology and how to make that a new enterprise capability to really fulfill on our mission as a company. So Mark touched on about this is about all these different components that go into a Myriad Complete experience, or just digital journey that we have for a patient, for the provider. There's a whole host of different tools as we walk through this process of identifying those patients that are suitable for testing, figuring out how to get them ordering, how to get them results, how to get them counseling. The key thing I want to talk about from a technology perspective is how essential this must be to be fully interconnected. These aren't 6 disparate products that we just pull off the shelf. We need this journey to be fully connected, so that you're not entering in additional information so that you can use any different particular product line is able and accessible and has a consistent look and feel across all of our products, so that they know this is the Myriad Complete experience and that we're really there is to partner for that entire testing journey. And we've seen the success of this. I think here's an example from GeneSight in particular, we're probably the earliest in our commercial transformation. And we can see about how a consistent delivery of new product capabilities over the past 2 years is really just continue to fuel growth. At the very beginning, we had the impact of the COVID pandemic, and we responded to that by having the ability to deliver the test directly to the patient. And even today, still 25% of GeneSight patients do the testing -- test collection within their own home. We then go on to expand the product capabilities with new Medicare ordering, ADHD content, and I think more importantly is all of the work that we're doing in order to enable that new sales model. How do we support inside sales? How do you make the transition from those interested in getting tested to knowing that their physician can actually order, become a Myriad customer and be part of our care network. And I think just at the very end, we're now launching a new capability to then follow up with the patient, take surveys of their results, PHQ-9 scores that will just add a wealth of data that we think about phenotypes and genotypes coming together to make new insights and new research that will power things that Dale's team can hope to do in the future. So going over to Women's Health, though, I want to talk about some of the core capabilities that we have here that we're launching later this year. The first off is the integration of myGeneHistory into the portal. myGeneHistory is probably one of our most successful programs. Over 1,000 people every day take myGeneHistory questionnaire either before they go to the doctor's office through an e-mail. And of that, we see a lot of success in the clinical practices. Those clinics that integrate with myGeneHistory see a 20% volume lift before and after integration. So a great program, great and driving the mission, making sure those that are suitable for testing, those are qualified and those that have provider coverage or getting the product that they deserve and that they need for their care. The next major launch that we're having is our fully integrated electronic ordering portal. And it's just obvious to say, but if you're having a Women's Health business unit with 3 products in their bag, Foresight, myRisk and Prequel, they have able to order that all in 1 place. And actually still to this day, there's 2 different portals. There's a really well-engineered portal for prenatal and there's a great portal for women -- for myRisk as well. And so what we've done is -- what seems obvious at first but requires a lot of the technical infrastructure behind the scenes is making it so we have a homogeneous order and support management system, a seamless customer experience, customer support capabilities as well. And so now we're launching that as a unified way for Women's Health to be able to offer all products as 1 solution. And this is important because only 70% or -- only 30% of accounts today are actually ordering both the prenatal products and the hereditary cancer products. There's 70% that will now be able to drive this attachment because we have the ability to order both in 1 place. And then finally, we have an expansion of our offering of the patient portal as well. So this is a place for people to be able to look up the results directly both in prenatal and in myRisk as well. So again, bringing that commonality in the feature set. I also want to talk about a real innovation that we've had in order to address that particular part of the market, the OB/GYN that really believes in genetic testing, wants to be able to offer this to their patients. But just doesn't have the time. They have 15 minutes in the well-woman exam, and they don't have time to go through the full story and the full odyssey of what it takes to get tested. And so they want a partner. Myriad wants to be that partner for them. And so we have a new capability that's rolling out here only in the next couple of weeks that allows them to quickly hand off and say, if you're at risk -- if you have a family history of cancer, you can breed -- brought into our digital experience. We can screen those to see who is eligible. We can counsel them about what would be appropriate next steps, and education, and then we're working with our telehealth partner, Genome Medical, to then be able to follow them through and actually be their provider and be able to offer them testing and deliver their results. And because of all these digital solutions and the price estimates, we were able to really provide this for those that are qualifying for those that have provider coverage for as little as a $40 co-pay. So it's a huge increase in the accessibility of testing. And as Mark described, there's only 24% of this market that's currently being addressed. And that addressment is not because the science isn't there. It's all because of what does it take to really be able to reach patients where they're at today in that OB/GYN practice and in that, well, women checkup. So -- and Myriad always really had the best products. I think there's never a doubt about that. Our commitment to science has always been profound and in paramount. But we're really showing these innovations about how we're bringing more and more into the hands of our patients to drive growth and to serve our mission. One key area of doing that, though, is meeting doctors where they're at. And so one of our more successful programs is how do we integrate with their EMR directly, making this the same system that they use to order every one of their other pathology tests or imaging labs or doing their patient consultation, they're there would be able to click button go and order a Myriad test as well. And so we've made a huge investment in this. And just in the last year or so, we've really devoted that investment around hereditary cancer in particular. But today, we've integrated with over 900 systems, 42 different vendors. And when we do these integrations, it has approval growth in order volume. It's about a 25% lift in same-store sales before and after the integration. And the acceleration of this program is only picking up. We had -- you can see we were originally thinking we'd go to 600 clinical integrations this year, and are on pace to exceed that with over 650. So about a 35% year-over-year increase in the amount of EMR integrations that we've been able to do. And we're only accelerating this further. And I think we just recently announced this partnership with EPIC. And this EPIC, the largest EHR provider in the country, over 25% of Myriad's current businesses with EPIC, over 50% of large health systems and those doctors, and with over 25 physicians are on EPIC. And so this is a really deeply integrated partnership. This provides a turnkey integration, so an immediate availability for everyone within this Care Everywhere network to be able to access EPIC. And we're thinking of this as not only a great expansion in our market access, who we can reach, who we can impact, but it's also approval volume growth. We expect to see that same 25% uplift in these accounts. But the integration goes further. It's not just ordering in results. What we really think about is also how this can facilitate deeper genomic data sharing, how we can have structured fields for genomic results, how we can return back full test varying call files as well. And this is just feeding into a larger data ecosystems that are increasingly more and more important for the providers, for the researchers, for the large health systems, and EPIC and Myriad working together is making that possible. All that's really feeding into our larger data strategy. And when we think about data at Myriad, we really bring it back to our mission. When we think about the purpose that we have, the care, the promise that we have for our patient providers so to treat that sacrosanct and also how to be able to make that serve ultimately to improve outcomes, to improve treatment. And we think about how much that is capable in driving the next generation in precision medicine. So maybe before we talked about health illuminated, and this is really health data illuminated, how we can take the data that we've had and work within the provider network. And I think distinctly, we think of ourselves being a partner in this health data ecosystem. Not us as the center of the universe, but really that health system, that researcher, that doctor that's trying to figure out insights for their practice. We're an essential component on this wheel, but we're trying to work in how we share data with research institutions, with our pharmaceutical partners, with health systems and payers and patient advocacy groups. And so really think about Myriad being a -- really allowing for the facilitation of this new insight -- this new health-driven insights market. And just how this impacts the business is we don't think ourselves being in the business of monetizing data and selling patient data. We really think people are going to choose Myriad because of how well we can work in order to share data back with them to be able to facilitate this health data information exchange. And that's ultimately our value proposition to the market. We do best when we do what we are best at, which is running the best-in-class molecular diagnostics. We want to take the insights, the data that's brought from that and to make us the chosen provider for every health system, every payer, every pharmaceutical partner because they know we are excellent at how we can handle this data and how we can work with them rather than creating this walled garden onto ourselves. So what data do we have? It's many years of proud tradition of innovation and research that has a huge data set at our disposal to leverage for this next generation of research. So about 7 million genetic results to date, about 2 million varying curations, over several hundred thousand low coverage whole genomes, about 450 samples accessible as well. And the real insight that comes is not just the genetic data in isolation, the unique capabilities, you have to be able to join that with phenotypes, longitudinal care, pharmacogenomic impacts, other multiomics data sets and other information as well. And a lot of that we've collected, and we have collected, and that's why we're trying to work in partnership with all these different people to bring that together into 1 unified place. And this isn't new to Myriad. We've been doing this for many years. I think we talked about the innovations in myRisk, especially the innovations allowed for that for risk or for all ancestries. That was something we've been working on since 2017. We first launched this best-in-class polygenic risk score. And then just last year launched the validations, the testing and the hard work that goes into making that work for all ethnicities. And that research took about 400,000 patient results that went into that research, making sure every ethnicity was represented to about 10,000 samples. And so fully being grained in the DNA of the company about how we think of data for the benefit of the patient, for serving the mission for advancing health research and driving insights. What are the components that all go into this? I think there's components about how we build the data infrastructure to support this. And it has several different pieces. But our core commitment to this is to integrate into open standards and extensible platform. you can think of things like ENCODE or TCGA or ClinVar, things that everyone is used to, everyone is working with that is part of the health ecosystem today rather than defining our own proprietary version or proprietary platforms. We think this is what drives access, this is what drives adoption and will increase Myriad being the chosen partner. So different components that we are building, tools for workflow visualizations, integrations with clinical outcomes and collection, and how this will allow people to have these treatment cohorts and these real data insights and powered data intelligence. But importantly, all wrapped up within the same -- the privacy control, the right use, the access, the permissions and making sure that we're always correct and proper with that sacrosanct in that [ increment ] patient data. And then finally, I just want to talk about how this has been working in practice. And so earlier this year, just in March, we not only launched the precise Oncology solutions for the combination of germline and tumor testing, but also our health data intelligence solution on top of that. And this was the precise treatment registry, which our goal is to have about 100,000 identified patients enrolled within about 3 years. It's going to be the combination of both the germline, the tumor, the liquid data. We've already prepopulate that with lots of tumor normal match samples. And today, about 35 researchers and institutions across the country are enrolled in that today. It's actually open to anyone, and 25% are new to Myriad. So it's a great way to fulfill on that strategy of increasing adoption of Myriad because we have this open data platform. And this is being done in collaboration with DNAnexus on their Apollo platform that is really tuned and optimized to be able to do this next generation of health data intelligence research, and be able to combine these different multiomics data sets. So a huge amount of our investment in both the customer ease of use, about these new innovations we're having. They're just starting to roll out into creating this core platform for our providers and our patients, and then a little bit about just our theories and our philosophies around our commitment to data. And with that, I'll turn it over to Dale.

Dale Muzzey

executive
#7

Folks are able to hear me now? Sorry I think we're still getting the mic started. Great. Yes. So I'm new to the stage. I just wanted to take a minute to introduce myself. My name is Dale Muzzey, I'm the Chief Scientific Officer. My background. Did my undergrad and PhD at Harvard in biochemistry and biophysics, and then went to UCSF post-doc in genomics. I was very happy to join counsel after that. And then Myriad subsequently after that. So I've been with the company for 8 years, even though I'm kind of new in this role, but we've got some awesome stuff to talk about today. So I'm really excited to get to that. So I'm going to be talking about some developments in GeneSight that are really important to share, and then some new products. So precise tumor and liquid I want to be talking about our MRD developments of late and then FirstGene as well. So good, exciting things on the docket and let's start with GeneSight. So very recently published JAMA was the largest pharmacogenomic mental health trial. This is the VA PRIME Care study. It's a randomized clinical trial. And before getting into the results of that, I'm just trying to sort of set the stage for like what is GeneSight? Why does it matter? We've heard some of the commercial developments, some of the technical developments, but just sort of on a clinical level, 8.4% of adults in the U.S. suffer for major depressive disorder. It's like 1 in 12 people. I passed probably several thousand just walking 2 blocks here this morning. There are at least 100 people there that have major depressive disorder, on average. 63% of U.S. adults though, do not achieve remission after taking their first therapy. So that is -- and it's not just -- I mean those folks that don't get to remission on the first therapy, there are many people who fail multiple therapies. And with each of those transitions, it can take multiple weeks that you're on that therapy. So there's a ton of people suffering from this. They do not get the drugs that they need the first time and transitions among those drugs take a lot of time. And so the key thing that GeneSight does it helps people find a medication that can work for them that is compatible with their genetics, right off the bat. So that's what it does. And it has a huge history of evidence behind it. So I'm going to be talking about the VA PRIME Care study, but there's a real history of lots of papers, lots of studies, thousands of patients. We have ones that are blinded. There are studies that are prospective, retrospective economic, clinical really runs the gamut. So the VA PRIME Care study is an addition to this legacy. And so if we now look at what it actually did. It had nearly 2,000 patients. These are U.S. veterans that were ages 18 through 80 suffering from major depressive disorder, who had at least 1 prior treatment episode, either treatment in cell and/or therapy. These patients were randomized to 2 different arms, one that either received GeneSight testing or received treatment as usual. The folks who received GeneSight testing and those other ones receiving treatment as usual, were tested at weeks 4, 8, 12 and 18. And 24, and they were tested with the PHQ-9 questionnaire. So this is the 9-question form, asks various questions on how they are doing and you get a store that can range from 0 to above 20. All patients enrolled had a PHQ-9 of at least score of 9. And what that study was looking at was multiple things, but key among them, how many of those patients underwent remission as a result of having or not having GeneSight? Remission is having a PHQ-9 that is 5 or below, okay? So there are 2 co-primary endpoints in this study. And this study was published in JAMA. I do wanted to start to discuss that again. It's extremely selective journal, except only the most rigorous work. And there were 2 co-primary end points, both of them were met. The first one of them was asking this question, does access to GeneSight testing lower the proportion of antidepressant prescriptions with predicted gene-drug interactions compared to the treatment as usual. The answer to this was, yes, it was statistically significant. And just to unpack what this sort of means, this is what a GeneSight report looks like. Based on a person's genetics, we report which drugs should either -- can either be used as directed, may have a moderate gene-drug interaction or a significant gene-drug interaction. When the physician and patients get this information, they can select a therapy path. And when they receive GeneSight testing, as shown over here on the right, there were more patients who had drugs that were -- that did not have gene-drug interactions, okay? And there is, as you can see in the red, a nearly twofold reduction in people who had significant gene-drug interactions. Critically, this trial was not one -- it was not interventional and direct, where we said, you must take a green therapy. The study was designed by people at the VA. Myriad did not design the study, we're not authors of the study. We provided the GeneSight testing, but it was very intentional that they wanted this to reflect kind of real-world use of GeneSight. And the answer was that people use these results. So this co-primary endpoint was met. Now the second one was also met and was answering this question. Over a 24-week time frame is access to GeneSight testing significantly improved the likelihood of achieving depression remission compared to treatment as usual and it does. It does own a significant manner. In fact, the GeneSight arm had a 28% greater likelihood of achieving remission than the treatment as usual arm. And you can see this tested at the various weeks. The GeneSight remission rate is higher and collectively over that 24-week period, it achieved significance. So again, 2 co-primary endpoints, both met. And -- yes -- and so you can find those results in JAMA, I encourage you to look at it. Now this doesn't -- development on GeneSight, clinical development GeneSight does not just end with this study. So internally, at Myriad, we are continuing our clinical validity and clinical utility assessment in patients with major compressive disorder. And we're also branching out into other areas. So for instance, we're next going to be verifying the efficacy in treatment of postpartum depression. And just to show kind of why this is important clinically for a second, they're about 4 million pregnancies, about 10% of them have postpartum depression. 90% of that goes unrecognized. So that means that only about 40,000 are treated. Most of those who are diagnosed actually don't even get treated. Most of those aren't even treated adequately and many of those failed to relate. At the end of the day, only about 0.4% of cases of postpartum depression are actually like treated fully to remission today. So this is a huge opportunity for GeneSight, to health these women. And critically, that just shows that, again, this product is not confined to our mental health business unit. It can also serve those in the women's health business unit. And so yes, we're really excited about not just the results from the PRIME study, but also further future developments on GeneSight. Okay. Now I want to pivot to talk about advancements in our oncology space with precise tumor and look at biopsy. Just to set the stage of like why do we care about this? Why are we offering this type of test. When a patient has cancer. There is a whole range of therapies available to them but those therapies are developed to do very specific things because they target particular parts of the cell. The person they have cancer because of a DNA replication problem. They should take a drug that's suited to a DNA replication problem, not something with metabolism, okay? So you want to profile of the tumor so that you can understand which of these drugs to take. And so we can do genome profiling that tumor, that helps them select the right therapy. So when we're talking about precise tumor and precise liquid, I'm really talking about therapy selection. I'll get to other parts of liquid biopsy testing in a minute, but this is for therapy selection. And so we offer already the molecular profiling tests and precise tumor for solid tables. And with the launch plan in 2023, we'll be expanding this to liquid biopsy availability as well. Now critically, these will both be run with the same underlying panel. So you get the same results, but this will just make it easier for physicians to use -- you can use it on sample types for a solid example, may be harder to biopsy and so the liquid biopsy would be available. This is being offered in collaboration with Illumina Intermountain Healthcare. The panel itself has more than 500 genes. I don't want to just slide past that. That's a big deal. The -- some of the established companies such as Foundation in the solid space and garden and liquid space, they do something similar here. The panels are smaller though. So this is a larger panel. And at the same time, like what we're looking for are like a variant in KRAS. With Illumina's partnership, their panel running at -- I mean, I'm looking at KRAS2 . I can find that variant as well. So -- and similarly, the therapy recommendation that comes from it. These are -- this is effectively open material. So that KRAS mutation points to a therapy that Garden knows about just as well as Illumina us, Intermountain know about and report to patients. So ultimately, you're getting extremely similar result, which actually you've been a larger panel. And again, both of these products can be used in sort of a stand-alone manner or for patients that start with a solid sample. If that doesn't work, we can then reflex to liquid. We can do that, though, in-house. We will offer both of these. We're not just one shop that offers one or the other. And then why would you do this with Myriad? Well, it's not just a couple of products here and there. We have the whole range of solutions. So not only do we offer the tumor profiling, but we also have the germline testing and the leading appended diagnostic for HRD detection. So it really just fits into a whole context of care, all of this gets integrated into the portal that Kevin talked about. So we're really excited about bringing this to markets in. And I'm now really excited as well to talk about -- these are not just the only parts of our oncology portfolio. We are adding MRD monitoring too. And so let's talk about that. So MRD monitoring is really trying to address 2 fundamental questions. First, is my cancer treatment working? And second, has my cancer recur? For the first one, if the cancer treatment isn't working, this may guide and shift to a new therapy like take a different approach, but it's sure valuable information to have, right? And if you also don't want to know if a cancer has apparently gone into remission, but it's now recurred, you want to know that as early as possible because that, again, sort of opens up your treatment options and makes them considerably more effective. So these are the -- this is why you do MRD. May I also look a little bit more deeply at how it works. So if we could take a tissue that had cancer in a tumor and sort of zoom into it, prior to any treatment or surgery, you'd see that there's a -- this would be the tumor cells in orange, and there's like a few normal cells in blue, but we're really looking at the tumor. Now post treatment, post surgery, you hoped that there are -- that you've gotten the tumor gone. But there's occasionally like how good your surgeon is, there's usually going to be a couple of cells that still persist. And that's problematic because over time, those cells can divide and ultimately, they do recurrence of the tumor. So it may start small, but at some point, that can get bigger. Now the key limitation is that imaging analysis or the standard of care to identify recurrence is really only able to work when the tumor gets sufficiently big. And so you can only really find it later in that recurrence path. However, with MRD, with a liquid biopsy, doing a genomic sequencing analysis, you can identify that recurrence much earlier. And that increase in lead time opens up key -- like clinical paths that were not open otherwise. And similarly, you can also identify post surgery, did you get it all? Like how much actually remained. And like this is just -- there's so much more sensitivity and quantifiability with MRD than with the other current standard of care. So the way that it works as well, the reason you can do this genomic test is because some cells just self die, they basically pop open and their genomes. The genomic DNA gets spit out into the blood stream. And so you can take a noninvasive just blood draw sample. And no matter where the tumor is in the body, some of the cells are turning over there and putting DNA into the blood stream. So I can take that DNA out of the bloodstream. And if I know what tumors genome looks like, I can sequence that DNA and see if there's any tumor DNA from anywhere in the body. So the first step in MRD is to take tumor cells, profile them to find out what their genomes look like. And you want to find out what is different about the tumor genome and the normal genome. And there will be, for instance, like literally a site in the genome where it's like it's a T in the tumor, and it's a G in the normal sample. That's one thing you want to find. We can find that at a ton of different locations, though, by doing this complete profile. So you build that profile and then you use that profile to assess the presence of the tumor at the later stages. So that T&G, you look for the T in the genome in the person's blood that you're sampling over time. Okay. So why should Myriad be able to do this? Well, I really want to make the case that like this is built upon core competencies we have today and not just things that we just started, like we've been doing things like the necessary steps for executing MRD we're really good at, and we do in-house right now. So I just talked about how there's sort of this preoperative tumor assessment where you like take the tumor and profile it. The necessary technology and skills to do that is really what we already have been doing for many, many years in myChoice CDx, but we do this every single day. Postoperatively, that residual monitoring, where you're now using a plasma sample, that's what we do with Prequel every single day on 1,000 samples, and what we'll be doing FirstGene is I'll talk about in a minute. So unlike some labs in the space right now, they have to send out various parts of this workload because they don't do it in-house, like we can do this in house. We are doing this in-house. So that's really important. So we have -- yes, we're doing this right now. Like this is not just something in the future that's all hypothetical. And I want to just now to give you a little bit of the flavor of what that assay is and show you what we have done. So there are 2 steps. There's the somatic variant identification that I will do about. That's what you're doing the profile of the tumor. And then you're looking at how many of those sites have tumor DNA that you found. For the first one, most competitors in the space do exome sequencing. That's looking at about 1% of the genome. For the Myriad MRD, we're going to be looking at the whole genome. That lets you identify so many more sites that you can then track in the blood later. And speaking of the sites that you're going to look at, competitors tend to look at 16. We're going to be looking at more than 500. And I'll show you in a minute why that matters, like how much more improvement that gives you to the test. So yes, really, again, this is a -- we're basically going to that sort of next-generation of MRD. And like we have extremely high confidence that this should work based on the confidence we have and as I'll show you in a second, we've gotten it to work well. So we assess the analytical performance of this approach on many cell line and patient samples at this point. I just want to take you through an example of one of them where we did tumor whole-genome sequencing and normal whole- genome sequencing, compare those to find the tumor-specific mutations, which found nearly 18,000 of those. Again, if I were looking at an exome, multiply that by 1%. The genome I have 18,000 to pick from, which means that I can then select many, many hundreds. I could go to more than 500 if I need to. Anyway, for this particular experiment, we looked at 777 sites. And then what we do is take tumor DNA and normal DNA and mix them in different proportions. And the most concentrated one is 1%. So this is one cancer genome for 99 normal cell genomes. And then I just leave that progressively to the point that I literally have 1 cancer genome for 100,000 normal genomes, okay? So this is very, very dilutive at the end of the day. And then we ran our assay. And what we do is for those many, many sites that we're looking at, I ask what percentage of sites have at least some observable tumor-derived DNA? At 1% tumor fraction, every single site has tumor-derived DNA that can observe. But now let's make it harder, go to 0.1%. And you see that almost 50% of the sites I look at have tumor-drived DNA. Now as you go to even further, there are still sites that have tumor-drived DNA, even as you go down to like 1 in 20,000 dilution, okay? So it's extremely dilutive. But because you're looking at so many sites, you can still see it. And so you can see that we still have significant sensitivity at the level where our competitors go, but even beyond that as well. And we can summarize that again in now a different plot where actually with sensitivity as a function of tumor fraction and also the number of sites interrogated. So if you look at 16 somatic sites, this is typically done with MRD today, it's performance to 0.1% tumor fraction and then really starts to taper off. As you add more sites, sensitivity does not fall as quickly. And this will ultimately be really -- this is important scientifically and clinically, but also just from the point of view of reimbursement. There are LCDs and NCDs that come out on MRD, they're very exciting. And basically, to also benefit from those, you want to be able to establish not inferiority there -- it is -- so not just not inferiority, but actually superiority by having more SNPs in the assay. -- more somatic site in the assay season. Okay. Cool. So just to finish off on MRD, like that's some of the like initial view, but like we are pursuing a range of initiatives. We are amassing a larger sample set to power our analytical validation study. We are leveraging our pharma partnerships with companies that we've worked closely with myChoice CDx, for instance, to also build out the sample cohorts. We are collaborating with Intermountain Health care on a prospective study for MRD. We are planning a large multisite prospective clinical utility study that we'll launch in 2023. And finally, we are also working as hard as we can to get to the point that we launched a research use only MRD early in '23. So again, we are really excited about the possibilities here for us in MRD. Again, we have these competencies. And having these competencies also means that we don't need to go out and spend several hundred million dollars to buy a company that does MRD. We can instead build the MRD using the things that we're already doing and actually put a lot of those resources instead toward the best clinical verification of that test that we can have. All right. So I want to move on and now finish with some talk about FirstGene. I'm really excited about this product. So I want to set the stage for like what it means, why it's different from some of the other things in our channel. So in OB/GYN may see more than 30 women in a day, like 8-hour day, they've only got a few minutes with each person. Now in those few minutes with each of these people, they need to do multiple things like they may have to do a breast exam, RH type testing, emotional status check. Like there's a whole bunch of stuff that they have to do. And similar, they then talk about genetics. And Genetics is hard to talk about with most people. And doing that 30 times a day, it's a challenge. And so we have heard the stress from OB/GYN. This is extremely hard to do. And the thing is that once they get further through the day, there are a lot of patients where they simply do not have time to talk about genetics. And that manifests as sometimes just not getting carrier screen. And in fact, that's what we see. A lot of patients don't get carrier screening. So -- and the reason it's hard to talk about it. It takes time to talk about carrier screening, so for instance, what they're trying to understand is my child going to have -- be affected with a severe recessive condition. And to have that discussion, the doctor has to talk about, well, we're going to screen the mother for a recessive care status. And if she's positive, then we need the father of the child to come in and get screened even though the father is not patient of OB/GYN, so there's a complication there. If they're both positive, then we have a 25% chance and just talking about all these things with patients who don't want to be thinking about genetics necessarily, it's a challenge. And like this really crystallized for me in talking to an OB/GYN one of our ad boards where he literally said like, if you make me talk about genetics for 30 more seconds per patient, I hate you. That's 30 seconds, right? Like, because they just -- they don't have time. And so how can we get that back from? That's what we wanted to solve. But really like, as I said, a ton of people don't get carrier screening, like many of them just simply aren't even offered, like in the grade circles. And a lot of people then, and this is like, will screen positive, but then their partner never gets screened. So they really never completed that sort of recessive risk assessment. So that's really true for about 50% of pregnancies. Now on the other side, there's also about 50% of pregnancies that are not currently getting an NIPS, okay? So there's really just a massive deficit in genetic care that exists today like in the OB/GYN channel. And so that is where FirstGene can really solve this problem. It is an integrated solution for basic prenatal screening. I think a good way to think about it is that it's really the first genetic test of the fetus. And as I'm going to describe in a second, it is a 4-in-1 solution, right? So let's unpack that a bit. First thing that's going to include NIPS for common aneuploidies, carrier screening for common conditions in the mother. Fetal recessive status, I'll talk more about this in a minute. So it will look to see if the child is normal carrier or affected for recessive conditions. And finally, the Feto-maternal blood compatibility, okay, to determine if the mother needs to or cannot take certain immunocompatible drugs. So those are the 4 things that it's going to offer. It is in one test that this is also critical. It is a single blood draw, noninvasively done off of just the pregnant individual. You do not need to know who the father is. If you don't need to get the father to get screening, it is just a test on mom, that makes it so much easier. And so I want to stress that this is not just a combination of Foresight and Prequel. We will still offer and continue to develop Foresight and Prequel.These are our expanded offering, but what FirstGene will do is test for -- and I'll talk about this in the next slide, but test was really the basic content, but I just want to stress that this is really game changing here in the orange. It eliminates that need for like testing of mother, testing of father and so on. And ultimately, because we can actually look and see whether the fetus itself as a carrier or effective like, this is much different from that 25% chance of being infected. This is really looking at the fetal genotype. So there will be fewer pregnancies, ultimately that need diagnostic follow-up, and those that undergo diagnostic testing, which they showed if they're screen positive on FirstGene, they're much more likely to be positive because they're getting a more informative result from the FirstGene test. Okay. Let's look at what's in it really quickly. For the Trisomies. We will be screening for Trisomies 13,18 and 21. These are guidelines recommended. I want to stress the other guidelines -- the part that is required is carrier screening for the conditions in the maternal sample, we will be screening for cystic fibrosis and spinal muscular atrophy. Those 3 guideline recommended items, all have clear guidelines and reimbursement. That is how we will be billing for this test. We have established by petitioning the American Medical Association that we are able to build all 3 of those on a single FirstGene test. So that's important. And then we offer multiple other versions of opt-in screening. So Sex-chromosome analysis will be an opt-in, 22q11.2 microdeletion syndrome testing is available as opt-in and actually performs extremely well on this test, excited to publish that. Next, the -- for the recessive side, we'll screen for the thalassemias, 10 additional common genes selected to maximize equity in care and finally, fragile X testing. And then we will be doing RHD copy-number analysis for the last part. Okay. So why is this test going to work so well? And we are taking the AMPLIFY technology that we've launched in AMPLIFY -- Prequel and porting that to FirstGene. So what this does is boost the fetal fraction to higher levels. Again, I'm looking at a non-invasive blood draw. I'm trying to find things about the fetus is genome. The more fetal fraction there is, the more genome have to work with. So the test simply just gets better as you move that way. And so with FirstGene, we're taking that same technology and getting higher fetal fractions than what you have with the only existing competitive offering for this test. And what's critically important about having that higher fetal fraction is the thing over there on the right, that we will have 3x fewer samples within conclusive fetal results. We have some already feedback from the field on this type of test with a lower fetal fraction where they're recommending oh, wait until week 13 or week 15 to get screened. That is a compromise you do not need to make with FirstGene because we will have higher fetal fraction to begin. Okay. So we have a clinical study underway to help with this. This will power our various publications in analytical and clinical validity. We're enrolling more than 500 patients that enrollment is underway. And from each of those patients, we'll be getting plasma and diagnostic confirmation so that compare all these together. And we're very happy to be working with our partners at the University of Colorado and Austin, MFM and are recruiting more sites as well. So I really want to summarize this here for FirstGene deadline. It is -- or in one testing but has really some significant benefits. We will have 3x the number of genes as the other available offering for this type of integrated testing. That said, we are doing it in a different way, such that we will have 2x a faster turnaround time than if you were doing this in a sequential manner, okay? This is one test, all integrated together, all the results available at once. As I said in the previous slide, 3x fewer samples within conclusive results. That's huge, like a doctor can be confident at 10 weeks that they will get results. And then finally, as opposed to unpacking the assay and running a carrier screen and NIPS and reflects into this and into that, by doing it all together, we have comparable COGS for this test as we do for our other tests. So it will be 3x lower than unpacking it and try to give you 4-in-1 otherwise. So at the end of the day, what we envision is not a field where 50% of people aren't getting screened but rather there are options that are available and pursued by operating people at the OB/GYN office that day, where many of them can get NIPS, some of them will get Prequel and Foresight. Basically, they have options available to them, and each one meets their different needs. So I wanted to revisit this. Nicole already showed it to you, but just again, like we've got some cool things on the road map, and this is really just a sampling of them, okay? I'm not telling you everything that we've done in R&D. This is just some of the things that we're excited about sharing with you today. So FirstGene, we are looking toward launch next summer. So this is really, really late in development. It's looking awesome. Our MRD as well, like is, as I said, moving to our RUO launch early next year. And so like we've got a lot of cool stuff going on revenues into our new facilities, and we're just really, really excited about it. Thank you for your time. And I'm going to turn it over to Bryan.

R. Riggsbee

executive
#8

It's -- I don't know who put the batting order. But first I want to reorient you to a slide that we covered earlier in the year where we laid out our growth plan for the next few years, long-term revenue guidance growth rate of 9% to 12%. I think importantly, when you look at our Q2 results in the first 6 months of this year on a year-over-year basis, we grew at 9%. And as you've seen a lot of the really exciting things that we've talked about today, what we're focused on is how do we build on that game momentum through 2022 launch FirstGene, MRD as RUO in '23 and really accelerate growth through the '22 to '24 time period. I'm going to double-click on a few of these areas and talk about each of our businesses individually. But what's really exciting to note as well is that in that long-term growth, we don't include things like MRD, liquid, some of the really exciting things that Dale talked about. So the foundational element of our growth rate, 4% to 5% contribution from GeneSight, really, that's a 20-plus percent type growth rate over time frame of 2022 to 2024. And really, when we think about the opportunity here, there's a huge need in this market. When you think about the impact of the pandemic and what its' meant for patients. We believe we have a test that solves to that, and it's evidenced in the 40-plus percent growth rate in volume that we've seen over the last couple of quarters. Also exciting is the addition of the PRIME study. This quarter, we released that the paper was published in JAMA. We believe that continues to build on the clinical evidence and provides also another opportunity for us to reengage and talk about expansion of reimbursement, which is a further catalyst to GeneSight growth in the coming years. Our women's health business, again, with development of products like FirstGene, what's really exciting there is the fact that we're really focused on access, equity of care, developing products that really solve to the patient and the provider need. Obviously, the clinical guideline committees have expanded areas that are covered over the course of the last several years, and we believe we're delivering products that will respond to that need. And that's about a 3% to 4% contributor to our long-term growth rate. And then finally, really the foundational element of Myriad historically has been our oncology business, and this is one where we probably had the most -- had to do the most to catch up over the course of the last couple of years. And I think we've made great progress. And what we're really focused on here is providing a full portfolio offering from germline testing to somatic testing, to liquid testing and then ultimately to MRD testing. So this will be a low to mid-single-digit type grower over the course of the next few years is our expectation, but really an exciting portfolio of products. I want to take just a couple of minutes to talk about our rev cycle investments that we've made over the course of the last 18 months. We have a phenomenal team at Myriad, and we talk about it every quarter, the great work that they've done that's evidenced in our financial statements. But I don't think that even I really appreciated the opportunity that we had when we started this journey a couple of years ago. And the really significant thing here is that we're focusing on all aspects of the rev cycle process. So from the intake process where we start the prior off all the way through how we manage things within the billing department, things like creation of denials management committee, where for root cause analysis for why we're seeing denials to the KPIs, to the incentive programs that we have for those teams. It's really a holistic approach. And we engaged a team from KPMG, who's been a phenomenal partner to us over the over the course of the project. And really, I'm just really excited about the engagement of the team and the results that they've been able to deliver. Whenever we talk with this team, though, we always come back to one sort of guiding principle, which is how does this impact the customer? When we talk about things like denials, we talk about it from the standpoint of how does it impact the patient that's seeing their claim denied or the payer who has friction in their process because we're not handling something or setting something through in the right way. And so I think that's really been the guiding principle. And one of the things that I think has made us -- allowed us to be most successful is just the fact that we keep the customer at the center of everything we do. And the results really speak for themselves. When you think about productivity of the team, the level of cash generation that they've been able to achieve, I highlight just a few of the metrics -- or the areas that we really look at regularly. The one in the lower left corner there, the prior of success rate is really significant, a 15% improvement in your prior off success rate is going to have a tremendous impact downstream in terms of your cash collection. And we've seen a significant improvement in our average cash collection per order over the course of the last 18 months. I always like to go back to you. Do you do what you said you were going to do? And so while we have areas that we're really -- that have been more successful or less successful, we always like to use the measure that we set out in May 2021 when we had our last Investor Day. Where We talked about focus on gross margin, focus on managing operating expense, getting back to profitability. And so I highlight those measures on the left here and then in the center part of the slide just show kind of how we're doing. I think the point is we believe we've made great progress across all these areas. Things like Lab of the Future will allow us to continue to make progress against our gross margin targets. We've done, I think, a really good job, the team's done a phenomenal job of managing operating expense. I always say it's not about -- a lot of times, it's not about how much you spend, it's about how you spend it. And so we've -- I think Kevin and team, as an example, in the tech area have done a great job of assessing what are we spending money on before? Do we think we're getting the right return on that? How can we reallocate that and deploy that capital in other areas? And then as we highlighted on our last call, this is all focusing us towards getting back to profitability and free cash flow generation as we enter 2023. I think one of the things that really separates Myriad from a lot of folks in our space is just our financial position, our balance sheet, our significant cash balance at the end quarter, access to the capital markets. And I believe this gives us a lot of flexibility when you think about things like our investments and operating expense that we talked about, deploying capital in tech and SG&A in order to take advantage market dislocation. It's -- I think it's the financial position that we're in that's allowed us to do things like that as well as over time, consider things like M&A. And then just a last slide here to provide a reconciliation, and then I'm going to turn it over to Paul.

Paul Diaz

executive
#9

Thanks, Bryan, and thank you all for participating today. We are, as you've heard from all my partners incredibly excited about our future. A lot of work and a lot of progress we've made over the last 2 years. But we have just really begun that journey. We've laid the foundation for, I think, great things for our patients, great things for our health care provider partners. And we have funded all that with a disciplined execution of operations. It is possible to innovate, grow and research and make money. So we're putting that challenge out to our industry. And where we go from here really as we talked about, whether it's on the commercial side, the R&D side, customer service side is just the beginning. We benefited from great partnerships. Bain has been an incredible partner to us in this. Bryan mentioned KPMG. Some of our other partners in the room today, we thank you all. But mainly, I want to thank our teammates for their resilience through the pandemic. We have done all this through the pandemic in a disciplined way, and we can't tell you enough about how excited we are about our future. And for those of you that have supported us over this transformation, we thank you for your support and confidence in us. So with that, I'm going to ask Dale to come up because he's twice as smart as I am to help me with the Q&A today. So let's open it up for some questions. Foster. Thank you.

Foster Harris

executive
#10

All right. I'm Foster Harris, Senior Associate, Investor Relations. Thanks again to everyone who made the trip out today. We've got some questions coming in online, but we're also going to have a microphone going around the room. And online and in-person, if you could state your name and company, that would help us out a lot. So we can start with Puneet.

Puneet Souda

analyst
#11

Thanks for closing today. So first question from Paul, when you look at the industry, obviously, transformation and you looked at now sort of, I mean, across the diagnostic industry. I appreciate the 12% organic growth that you're putting out for 2024, but I mean, when you look at this industry, there are a number of products that have delivered significant growth over the past few years. And if you look at even the sort of industry average, it's like mid-teens and maybe just north of that. So sort of why 24% after all of this transformation and product launches that you have coming ahead?

Paul Diaz

executive
#12

Our philosophy is to make sure that we can exceed expectations but we think there's tremendous growth in the mid-teens, just getting our fair share of this market. We certainly have aspirations to do better but we still have a lot of work to do. We're still making up for a lot of lost ground over the years, the lack of investments. And as you've heard today, much of the things that are really going to propel and drive growth are just happening in Q2 and Q3 and Q4 of this year. So it has to come together. What I think you've also seen today is the management team is focused on execution and delivering, and that takes discipline and that takes time. but it's also foundational to an industry that -- and a platform upon which we can do M&A, we can launch new products. And so I think the 12% organic growth rate is achievable. We're going to certainly work hard to exceed that. And on top of that, we're going to be able to deploy capital in an environment where others are really struggling to figure out how to execute and do the basics. And so I think the leverage in our operating model and our P&L sort of speaks for itself. It's 70%, 72% gross margins, that disciplined. We've done all these investments and OpEx has only grown 6% to 8% in terms of our guidance. So that's really important. So a lot of change in reprioritization. And so if you think about EPS growth over the next couple of years, there's tremendous leverage in our operating model, we can continue to maintain that discipline at this point.

Puneet Souda

analyst
#13

And just a follow-up and for those listening on the call, I'm Puneet Souda SVB Securities. Just when you look at the overall -- some of the products where you're positioned, you're launching FirstGene and maybe a question for Dale on this. I mean these markets on the NIPS carrier testing side and as well as on the tumor CGP side, in these markets are mature-ish. I mean they're penetrated almost near 40% or so. You're launching new products into these technical differentiation is there. But product adoption is going to really depend on the clinical -- clinicians taking this data and more importantly, taking the clinical data and those outcomes and taking action on those. So mean that might take a few years to just get those publications out given the time lines that you're projecting. So how should we think about the sort of adoption of these new products in a fairly competitive market?

Dale Muzzey

executive
#14

Yes. So the like FirstGene launch, I'll just talk about that one as a lesser example, like with -- like we'll have an analytical validation that will be like accompanying that. And that analytical one will sort of have some of the clinical parts sprinkled into it to where we will have samples that are confirmed to be positive, some confirmed to be negative, and we show that FirstGene gets it correct. We've actually already done that in most of our development process. The performance of this test is exemplary for carrier screening for the NIPS part. So I feel very confident that not just with the validation paper that will come out with the launch, but also with ones like I really ensure order thereafter, because we have a lot of volume to apply it to that turn will actually be quite quick. In a way, like the test integrates things that people are familiar with, and you could look at that in a negative way, but actually, it's more like it's integrating things people are familiar with in a way that makes it easier for them. And seriously, I've been in the field a ton of times, talk to these doctors to these counselors and like having things be easier is what they want. And so I think that this really achieved that. It would be much harder because for some totally different new type of screening. So it's actually close enough to be comfortable, but then easy to use. So I think the adoption will be quick.

Paul Diaz

executive
#15

And I just think we're still in the early innings here. I started to sort of differ. I think that expansion of guidelines, expansion of coverage, being able to bring these products to market in a more efficient way, all go into the adoption perspective. And so we're positioning ourselves to regain market leadership here in a market that we think is still in the early stages and do it in a profitable way because as you've seen our ASP and prenatal has grown, our COGS are managed really well. Nicole and the team has just done a great job. And I think that's what it's going to take to have a sustainable long-term growth model and a profitable company.

Foster Harris

executive
#16

Thanks, Puneet. Dan?

Daniel Brennan

analyst
#17

Dan Brennan from Cowen. Maybe a 2-parter. So Paul, a lot of interesting growth initiatives and operational initiatives. Just wondering how M&A fits into the strategy. You obviously have a great channel in the balance sheet. So maybe you could speak a little bit to that. And then maybe just one question, a high level on GeneSight. I'm sure there will be many others. But just as we cycle past the VA results, like what's -- how do we think about the impact going forward? Can you maybe unpack a little bit that 20% growth? Maybe if you look out over the next 12, 24 months, like what are the key milestones we should be looking for post that study? And whether it be coverage or kind of more provider starting to use it?

Paul Diaz

executive
#18

Yes. Again, the 20% growth rate is much slower than we're growing right now. And so again, we want to have realistic expectations here, but the market demand is huge, as Mark talked about, adding 2,000 to 3,000 new providers every quarter. So we think that the PRIME study just allows us to engage with payers again to expand coverage. And so we think we're in the early stages. And look, a lot of people wrote GeneSight off when I got here. And we took a step back. We redid our commercial model. We've worked hard to add to the body of clinical evidence and we've reintroduced it to the marketplace, and we've had phenomenal success. And so again, given the size of the market opportunity, tragically, the -- as Bryan mentioned, the extent of mental illness in the country today coming out of the pandemic, we think there's plenty of growth opportunity here to maintain that 20% plus growth rate with really modest expectations about expanding coverage. We think we're going to be able to do that. But that 20% is not predicated about us signing a big payer. It's about continuing to execute in the way that we've been doing. On the M&A front, we're going to be very disciplined about deploying capital and whether it's tuck-ins or other opportunities that present itself. And having done a fair amount of M&A over the years and pretty successfully, it is about integration, about culture and people and process. And I think we've built the foundation to do that, which I think is differentiating in the marketplace. But the industrial logic of M&A at a big scale in this industry is not clear to me. And so we're going to be pretty careful about that. And certainly, we're not going to jeopardize our mothership by bringing other people's problems into our house. So that will limit some of the M&A as well. But we'll certainly be opportunistic when we think we can add something to our platform and to our product lines that is differentiated.

Foster Harris

executive
#19

So a related question that we're getting online from Derik De Bruin of Bank of America. Is how should we think about these new GeneSight VA trial results impacting pace of payer reimbursement. And does ASP need to go lower in order for that reimbursement to uptake?

Paul Diaz

executive
#20

So we're engaged in a lot of conversations with payers right now. And certainly, the clinical validation and is incredibly supportive. And we're prepared to be proactive in terms of our pricing discussions. We've got GeneSight to be a very efficient product right now, and we want to expand coverage I think it's dangerous to give up price for volume in health care, a lot of people can burn that way. But at the same time, I think we've got our cost in a way that we can be more expansive, whether it's in managed Medicaid plans or others. And we've entered into a few value-based contracts that are sort of in the early stages. So Again, the 20% growth is not predicated upon some big signing of the payer contract, but we do think there's going to be opportunities there, and we're excited about that over the next couple of years.

Foster Harris

executive
#21

Jack?

Jack Meehan

analyst
#22

Jack Meehan, Nephron Research. Paul, you've said a couple of times EPS growth and profitability. You obviously have a number of investments going back into the business and you have 2 big coding changes, which are going to impact 2023. So I just want to be clear, do you think you'll be profitable next year?

Paul Diaz

executive
#23

We're going to be profitable coming out of this year to be clear. And the reimbursement changes that you've mentioned, we've taken into account in terms of our guidance and the growth rates that we've talked about. So we have a high level of confidence terms of those things and have worked through that as we talked about off-line, Jack.

Jack Meehan

analyst
#24

Okay. And then the second question is you have the Validac that's been working through Congress. Historically, pharmacogenetics has been an area of focus for the FDA. So just curious how you handicap the potential risks of GeneSight were regulated, what changes would you make to the commercial strategy or the test?

Paul Diaz

executive
#25

Yes. As you know, from years back, pretty active in policy in D.C. So we've been staying very close and working with our association partners. We actually think that Validac brings stability and clarity to the industry. So we are supportive. It doesn't seem to be working its way through Congress, particularly quickly right now, just given all the other things. And in our engagement with the FDA, we do not see the level of concern, and we've worked very hard with GeneSight in terms of our claims and marketing and some of the things that the FDA had raised previously. And we've done that across all of our product to really be very careful about the statements we make and the assertions we make about the clinical validity of our products. So certainly, it's an area we're going to stay close to. But right now, generally, I think companies like ours that have had success in reimburse that success with the FDA, success with New York State. If you think about where they'll contract out and our capabilities to advance products through these different stages, that's a great strength for us. Not many companies in our industry have the regulatory history and success that we've had, even just recently with the FDA moving NovaSeq transition through the FDA for our companion diagnostic. We got that done through the FDA in pretty quick time because they know us, they know what our capabilities are. And again, it's decades worth of work with these organizations. So we'll continue to engage in that, but I think that that's a strength of the company that we can continue to build on.

Foster Harris

executive
#26

Dave?

David Delahunt

analyst
#27

Dave Delahunt, Goldman Sachs. Thanks, Paul and team for hosting us today. So you showed really strong results with GeneSight clinical utility, clearly, a growing market opportunity, a lot of appetite for demand. Any thoughts on future opportunities for other pharmacogenomic indications?

Dale Muzzey

executive
#28

Yes. Well, I mean so the postpartum depression is really a key place where we plan to sort of use even just the current GeneSight test to understand how well it would predict the utility for like drugs during that period. So that's an end, yes, absolutely, there are ways to branch out into other indications. And really fundamentally, what GeneSight does there's -- we look at variance in the person's genome. how they impact, how the certain metabolic enzymes work. And we really are very conservative in terms of how we report that. And we've worked with the FDA and CPIC and other guideline agencies that really characterize how drugs are metabolized by those enzymes. We put that information together, and that's what ends up being GeneSight report today, but you can easily integrate that with other FDA-approved drugs in other indications. So really, the platform is extensible and that is definitely something we're evaluating.

Paul Diaz

executive
#29

I think more broadly, strategies about choices and how execution. And what I think you've seen today is that we're trying to work within our capabilities to do those things that we think are actionable and create market opportunities in the channels where we have a right to compete. There's a lot of other cool stuff that's sort of in the works. But my obsession, even with the guys who I want color outside the lines is, does this fit within our mission? Is it actionable? Can we make money? And does it serve a patient need? So we're just trying to put this through a lens of something that we can get through to the other side. But there's certainly a lot of other areas we're looking at that we're excited about. And today, we just sort of showcase the ones that we are in the near term. We think are highly actionable and where we can be successful, like MRD, like liquid and other things.

Dale Muzzey

executive
#30

On a technical level at [indiscernible], so that allows you really to evaluate purely on a strategic level, like it's not like it's some huge mountain you have to overcome technically to expand. So yes.

Paul Diaz

executive
#31

Yes. And just generally, the company had muscles at atrophy pinned and we're just wiping it back in shape and getting back out in the field. So sorry that's sports analogy.

Foster Harris

executive
#32

Andrew?

Andrew Cooper

analyst
#33

Andrew Cooper, Raymond James. Maybe thinking a little bit longer term and on MRD maybe for Dale. We saw some of the analytical data you put up today. But when we think about building that clinical data, going from RUO to a commercial product, I understand it's early, but -- how do you think about what the structures of those trials need to look like, what the sort of prioritization of the data you want to show to get to commercial markets, whether it's by indication or use cases, just how you think about that and what the time line we should think about are would be great.

Dale Muzzey

executive
#34

Yes. Like to these calls rate, we're really in the early innings on the clinical scoping, but we have in mind exactly what you talked about. It's sort of like which indications do you think about for us, we're very deep in thinking about that. How many samples do you need to power the study? So yes, we're currently evaluating all of that. But our focus is really getting the RUO product like out and available. And that becomes a catalyst for that kind of clinical engagement. So having it in the hands of our pharma partners and also just our clinicians who are interested in using a more comprehensive, more expensive test, like it really -- it's sort of a positive feedback group to them get that same clinical engagement.

Paul Diaz

executive
#35

Yes. And look, that's an important part. And look, we've got some great work that's happened to other companies that have led the way here, but we're in the early stages of MRD in terms of adoption. But quite frankly, as we've seen with people following us in hereditary cancer. We'll be able to benefit from the great work that some of the other companies have done. Also, we haven't talked about it as much, but expansion of my choice beyond ovarian is a huge opportunity as we partner and sort of similar thing. How can we move from research only into clinical studies into reimbursement? The path is much shorter for us that would have been for others who led the way, frankly, over the last couple of years in a market that's still 2% to 3% penetrated. I mean, what you heard from Dale is this huge patient opportunity to change how we deal, treat and monitor cancer. And so we may be 2 years behind, but we're going to catch up quickly in a place where we have a right to play and a right to be successful. So we've got a lot of work to do, but we've caught up a lot in 2 years, I think, most would acknowledge.

Andrew Cooper

analyst
#36

Great. And then just a quick follow-up, thinking about the RUO launch in early '23. Any notable kind of financial assumptions involved in the '23, '24 guidelines you're talking about from a pharma perspective.

Paul Diaz

executive
#37

Zero.

Unknown Analyst

analyst
#38

[indiscernible] with Bank of America. So I wanted to start off on MRD. The space is pretty competitive. You've seen companies like personnel is doing tumor-informed MRD call with 1,800 lows. In your presentation, you guys mentioned the 500 lose approach. Why is that going to be better? Is that going to improve sensitivity? Or are you guys going to offer but a work close turnaround time, a better price point because if the argument is the more low side, the more accurate then why wouldn't people go with the other approach?

Paul Diaz

executive
#39

I'll answer the business question because 82% of the ecologist we talk to want it all, and they want it in a simple-to-use report. I'll let Dale handle the scientific answer.

Dale Muzzey

executive
#40

Yes. I think in terms of the number of sites, choice, like that is still flexible. This is one of the reasons you launched an RUO and kind of figure out like where things are clinically and in terms of the market. The good thing is by doing the whole genome sequencing, if we need to go to 3,000 sites, that's fine. It's more expensive there's nothing magical necessarily about 1,800 versus 500. It's really just like linear in cost at that point. But yes, we'll see where we like the clinical need is. But like technically, it's effectively trivial to scale up to any number of areas that we can identify in the genome.

Unknown Analyst

analyst
#41

Got it. That makes sense. And then what's your view on tumor-naive approaches such as garden [indiscernible] for example.

Dale Muzzey

executive
#42

Sure. Yes. I think they're very interesting. And we -- like I do want to be clear, we do have interest in that light. We're looking at that ourselves. I think that the -- like we feel and we did evaluate the various different approaches that a tumor-informed approach really will be more sensitive, right? And I can -- you can find recurrence when there are even fewer cells. I believe that a tumor naive approach can work. I think it will happen at a higher tumor fraction then you would be able to do it this. Just on an intuitive level, if you literally have probes that are looking at exactly the tumors genome at like 500 or 1,000 sites or something like that, that's simply going to be a more sensitive approach than something that is really not like actually tuned to the tumor itself.

Foster Harris

executive
#43

I think we have time for one more question.

Paul Diaz

executive
#44

Great. Anything else?

Foster Harris

executive
#45

No, That's it.

Paul Diaz

executive
#46

Good listen, thank you all and came in person. We actually got a good turnout. It's great to just have the energy of seeing people in person in the room. Again, just to shout out to all our teammates, people have worked really, really hard. You've seen a lot of that progress. We've got a lot more work to do. But we really are excited in our future and our ability to really take advantage of all the incredible sciences happening here and that will continue to happen and to make that actionable and meaningful for patients and providers in terms of how we care for folks. So thanks again for participating today, and we look forward to keeping the discussions going. Thank you.

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