Myriad Genetics, Inc. (MYGN)
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Investor Day 2022

Aug 11, 2022

Paul J. Diaz
President and CEO, Myriad Genetics

Welcome to Myriad Genetics Investor Day. Really pleased for you to join us today. 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 reliant on coordinated care and informed patient engagement are becoming the norm throughout our healthcare system. We see a growing interest and adoption by patients, payers, and healthcare 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.

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 a 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 way more effectively do business with them. You'll see in the presentations today our significant efforts to meet this demand and opportunity. At the same 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.

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. Adoption and success are gonna 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 socioeconomic condition. Risk score for all ancestries and Prequel with AMPLIFY are good examples of that. We've also been working hard to create greater transparency and improve patient 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 up much of this ground 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. 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 plan for 2023 and 2024.

Speaker 14

Myriad has always been the world leader in germline testing. No question. The've also been a dominant player in somatic tumor testing somatic. Now, they are becoming the world leader in both.

Speaker 15

Intermountain Healthcare, along with Myriad Genetics, represent an extraordinarily innovative partnership of two innovative companies joining forces. It's remarkable. There's nothing quite like it that I'm aware of.

Speaker 16

Clinicians have been clamoring for a long time for information about how to organize and streamline all this biomarker data. They are the industry leader when it comes to genetic and tumor testing. It's just thrilling to be a part of all of it.

One cannot offer a polygenic risk score to only women of European ancestry. It simply is not right, and it needs to be accurate for women of all ancestries. That's where Myriad really was innovative this year. MyRisk, with risk score for all ancestries, I was fortunate to participate in that working group, and the innovation of recalibrating the polygenic risk score from European women to be applicable for all ancestries is really important for patient care. It's wonderful that we now have a concise, organized platform for organizing all of this data and to make it very easy for clinicians to do point-of-care testing and order this in our office to help our patients.

Speaker 17

The best scientific innovations, in my opinion, are those that can be directly applied to patients.

Speaker 18

GeneSight tests has really helped me in my practice by really giving me a more concrete underpinning for precision decision-making with my patients in terms of medication management. It's been probably one of the best tools I could have in my toolbox for patients in the past 10 years.

Speaker 19

I'm very excited about the Precise platform. It's truly remarkable that Myriad is actually providing these tools that, in the long term, it could certainly lead to better patient outcomes.

Speaker 20

We did it, finally. Now we can send specimens from one patient to one lab. This idea of sending the germline DNA there, the tumor tissue here, now we have one comprehensive solution, and Myriad has created that.

Speaker 21

It's incredibly important to have a reliable lab, to have safe practices and rapid turnaround so that women can make surgical decisions in a timely fashion. Innovative companies like Myriad, you know, are at the cutting edge.

Paul J. Diaz
President and CEO, Myriad Genetics

You got to love Dr. Bradley Monk. He took us to task, and after many years, we finally listened and started responding with 15 gene expansion for MyRisk and other things. Great science and innovation don't change lives unless we can make them accessible. We've certainly dug out of our tech deficit, and Kevin will talk about that. 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 and providers and engage with them in a differentiating way. We're really excited about the prospects for growth of this new model. I'm going to have Mark come up and showcase for you.

Mark Verratti
Chief Commercial Officer, Myriad Genetics

Thank you, Paul. Welcome, everyone. Let me get a mic here in 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 than 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, when we show up every time in the doctor's office, we have to fill out five pages of information with a No. 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 doctor's office, right? Just simple things. Finally, the healthcare 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 could be more excited to share that with all of you today. 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 three key components to that. Number one, as Paul mentioned, is around the Myriad brand. 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? We talked about the commercial capabilities. How do we bring those? They are in one business unit that I'll talk about in mental health. How do we take them to the other business units?

Lastly, as you heard our physicians mention, 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 sales and commercial guy to grow our business. 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.

Starting with the brand, we're not only saying that, but we want to make sure we could back it up with data. If you look at the top graph, that we went out back two years ago in 2020, and we talked to patients and consumers who understood the Myriad brand as well as all of our competitors. We went back two 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?"

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 had that same gain. In some cases, some of our competitors actually went down. 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. 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 and to the right, everything is going in the right direction. Are we perfect? Absolutely not. Do we still have room to grow? For sure. I think what we're seeing is a more data-driven of the things that we're doing, can we actually measure and make sure that they're resonating in the space.

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. 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?

In the primary care space, there's over 1 million providers that are writing antidepressants or that are treating this space. 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, 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, last 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 five plus quarters, we have been able to add over 3,000-4,000 new providers, every single quarter, writing GeneSight for the first time. Okay. The model is working to be able to reach more and more clinicians, which ultimately means more patients benefit. Let's talk about what that looks like. A little bit of an eye chart. I'll start all the way over to your left. Again, very large addressable market.

The way we're defining it here is there's roughly five million patients who suffer from depression, anxiety, or ADHD, who are seeing a clinician, already tried a medication, and unfortunately, that medication didn't work. I'm sure many of you and many people who you know have suffered with that trial and error. That's how we're defining that five million. 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? 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? 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 on 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 physician's information so we can educate your physician? Do we need to connect you to a physician? Ultimately, what that lead gen model allows us to do is, as I mentioned before, that 3,000-4,000 physicians per quarter, 80% of them came in through our website. 80% came in through that channel. Okay. Great stuff here. If you can't tell, I'm a little excited about that. What I'm mostly excited about is thi slide is, when we think about our other business units, right? 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. Three to four 4 million pregnancies. Again, only about 30% are getting tested.

Go to the tumor profiling. Almost one million patients are diagnosed with cancer, and less than 40% are getting tested. 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, kinda duking it out against competitors. They also make us better. 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? Today, despite the fact that we're not the best we can be, we're helping over one million patients a year.

I mean, that's a 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 set up a Net Promoter Score program where now, real-time, we're getting real feedback from our clinicians as well as our patients. We make sure that we're doing the right things, right? That's like when you fly on Delta and whether you had a good experience or bad experience, you immediately get that little survey result that says, "Hey, what do you think? Would you recommend Delta again?" Same type of experience with a couple 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 Columbia or Cornell. 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's gonna talk a little bit about the tech behind this Myriad Complete solution. What we've seen when we've worked with our providers, and this is an example, and I'll kind of walk you through sort of the numbers going from one to three on. In talking to our clinicians, 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 patient's coming in, do I need to consider hereditary cancer testing on? We have the ability through Myriad Complete, either in the office or even outside of the office, to help them do all of that pre-screening before you get there. Again, all of us have been a part of that, of go to an office and now wait.

Again, I mentioned the five-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, 'cause many of us in this space realize, well, now that I qualify for this, what do I actually qualify for? Right? Physicians who are limited on time, we're 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.

Then the most important question that all of us are starting to ask, surprisingly, is, well, now how much does this cost? Which for years, we never really asked that question. Now, surprisingly, it'd be really, really nice to know at point of care before I say yes, how much is it gonna cost me? 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. 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 in email.

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 in the R&D side as well as on the commercial side. You're seeing how we're gonna be taking those commercial capabilities that I talked about to our other business units. Kevin's gonna talk more about the EMR integration and how we're partnering with larger health systems.

That's important for today, but it's gonna be really important after you hear Dale talk about the new products that we're gonna have so that we can bring those products and we can launch them to market in a much better way than what we've been able to do before. Not only the products that we're gonna do here at Myriad, but also any M&A opportunities that we have along the way. Hope this was a little inspiring for all of you. I look forward to talking to you afterwards if you have any questions. On that, I'm gonna turn it over to my partner in crime, Nicole. Without falling off the stage.

Nicole Lambert
Chief Operating Officer, Myriad Genetics

Off the stage. Thank you, Mark. It's my pleasure today to talk a little bit about 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 two 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? 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, are we 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 scorecards 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. 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. A little bit, we've bucketed these metrics into five buckets, and there are about three metrics in each of these buckets.

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 gonna fuel a great customer experience and growth in our tests and growth in our business.

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. If all of these things come together well, we will deliver on the financial performance that our external stakeholders expect of us. 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, in launching new products, and making sure that we can continue this mission for the long term.

I'm gonna talk through what the metrics are in each of these buckets and how we're trending. The one on the left we're very excited about in terms of employee turnover. If we think back about two 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. 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. That makes a huge difference to our customers and the perception of us in the marketplace. 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 with 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. Does our employee base look? Is it representative of what our customers look like? Can we be proud of the diversity that we have at all levels, getting up to the top levels of our organization? That also is trending upwards.

Turnaround time. This is critical for, 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 is-- has an ovarian cancer patient in front of them, Stage 4, they don't have many treatment options. They need to know which treatment option to use as soon as possible. Turnaround time is critical for us. We've always been good at this, but we continue to look for ways to do better. We intentionally put this as total turnaround time, not just laboratory turnaround time.

Everything that the customer would experience, whether that is the time it takes for us to get a pre-auth, 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 gonna 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. 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.

Audit findings. These are internal audits. We continue to challenge ourselves from a quality assurance 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 one to be steady because we wanna make sure that we are reporting and identifying patient problems as well as resolving them. We don't wanna discourage anyone from reporting a problem if they find it. We also wanna make sure that we continue to investigate those and resolve it. There's a certain amount of those audits that we wanna make sure we're constantly improving in our laboratories.

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 might be physicians that are ordering from a competitor or have ordered from a competitor and have decided to give Myriad a try. 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. 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 and more of their business? 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 is 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. Then all of that comes together for the right financial picture. If we're operating the business effectively and efficiently, you will see the financials that we need to continue our business goals. Bryan will talk a little bit more in detail about the financials later. One of the most important things for me and one of my focuses going forward is taking some of this revenue and investing it into improving our operations and our ability of our laboratory to continue to serve our patients.

I'm gonna talk next a little bit about our laboratory of the future. In order to support this growth and productivity and innovation, I wanna 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 headquarters 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. 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. 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. Let's take a look.

Speaker 22

We're bringing this next generation of capability to Salt Lake City with a major investment from Iris and flexibility for future product innovation. Because at Myriad, we have full system integration from the lowest level actuators and valves that do the actual chemical processing for next-generation sequencing, to the applications which run each particular instrument, to the real-time imperative scheduling of every little motion of a robot or a piece of apparatus in the work cell. It's a whole lab orchestration like we see here. It gives a bird's-eye view for both lab supervisors and scientists to make sure everything is working appropriately and immediately address any issues.

Speaker 23

In lab automation, we have really tried to basically bring the best practices of a manufacturing kind of processing plant to the genetic laboratory, which was like something that was new and innovative that no one else has done before. We have a fully automated integrated laboratory that runs 24/7. It's fully lights out automation, which basically means that we can go ahead and put in a patient sample, like a blood tube, for instance, and then into one end, the robotic system will go ahead and process everything, and then out the other end, we'll have a vial of material that's ready for sequencing. Because they're robust, they keep doing the same thing over and over again, there isn't as much room for error.

Speaker 22

When we say automation, we really mean it. The real heart of the operation is the speed of six-axis robotic arms and the slide that serve as a material bus for the entire integrated lab. We're able to assemble every essential liquid handling instrument, every plate spinner, centrifuge, labeler, refrigerator, all in one place. What that means is our vertically integrated software stack is able to dynamically schedule multiple different product lines and dispatch samples to exactly where they need to go in the lab. This lab is just more efficient. We only require a quarter of the floor space of a typical competing lab. We only require half of the scientists, and the net benefit to the patient is better access to testing.

Speaker 23

What we've really been able to do is give more accurate results, more reliably and in a faster manner to our patients and our providers.

Speaker 22

With modularity to accommodate advances in next-generation sequencing and scalability to support multimillion samples per year in one facility and one lab technology backbone, all for the benefit of the patients and providers we serve.

Nicole Lambert
Chief Operating Officer, Myriad Genetics

Very good. We're excited to move into that new laboratory. I think historically there were places that we had underinvested 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 a people strategy that aligns to the people that we need in each of our locations to run this process effectively. Really, this is a multi-pillared approach to solving this problem that we talk a lot about, a lot about the real estate, and we, will move into more modernized facilities. Really this gives us an opportunity to enhance our current processes, make our current tests 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. Really, you know, scaling for growth. The automation, as Kevin said, allows us to increase capacity dramatically. Basically, for every line of production that we convert from our current methodology to the new automated methodology, we get about a doubling of capacity of how many samples we can throughput those labs. They are, as Kevin mentioned, very efficient, very small footprint. If we need additional production capacity, it's easy to add another cell or another line of production.

We're confident that we can scale for our future needs. I'll give you a little bit of an overview of the timeline. Essentially, in the next two to three 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 timeline. 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. Then that will allow us again to launch new products into that line, into that production facility very, very quickly. With that, I will turn it over to Kevin.

Kevin R. Haas
Chief Technology Officer, Myriad Genetics

Excellent. Thanks, Nicole. 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, we're talking about all the technology behind the scenes that goes into powering that and making that possible. First, just want to reflect on the journey we've been through as a company. This 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. The reality is technology was an area at Myriad that we had underinvested 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 was a homogeneous experience for all of our different product lines. Essentially, a lot of the core systems at Myriad had reflected both the expertise of the 20 years that we've been running those products, but also the cruft, the complexity, the technical debt that we had acquired. What was essential is we'd make a major investment overhauling these core systems. About two 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.

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 for all ancestries, a new Precise Tumor launch with a new integrated electronic portal. We had new pricing options and gene expansions. 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. I think what's important to note is this, all this investment's 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.

I think what we're-- then gonna talk about a little bit 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? What 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. 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 their provider.

There's a whole host of different tools as we walk through this process of identifying those patients who 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 six 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 as their partner through that entire testing journey. 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 two years really has continued 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. Even today, still 25% of GeneSight patients do the testing, the 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 the work that we're doing in order to enable that new sales model.

How do we support inside sales? How do we 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? 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.

Going over to women's health, though, I want to talk about some of the core capabilities that we have here that are launching later this year. The first off is the integration of myGeneHistory into the portal. myGeneHistory is our, probably our, one of our most successful programs. Over 1,000 people every day take a myGeneHistory questionnaire, either before they go to the doctor's office, through an email. That, 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. A great program, great in driving the mission and making sure those that are suitable for testing, those that are qualified, and those that have provider coverage are 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. It's just obvious to say, but if you're having a women's health business unit with three products in their bag, Foresight, MyRisk, and Prequel, they have to be able to order that all in one place. Actually, still to this day, there's two different portals. There's a really well-engineered portal for prenatal, and there's a great portal for women for MyRisk as well.

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. Now we're launching that as a unified way for women's health to be able to offer all products with one solution. 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 one place.

Finally, we have an expansion of our offering of the patient portal as well. This is a place for people to be able to look up their results directly, both in prenatal and in MyRisk as well. 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 the time to go through the full story and the full odyssey of what it takes to get tested. They want a partner, and Myriad wants to be that partner for them. 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 be 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 in education. 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 them results.

Because of all these digital solutions and the price estimates, we were able to really provide this for those that qualify and for those that have provider coverage for as little as a $40 copay. It's a huge increase in accessibility of testing. As Mark described, there's only 24% of this market that's currently being addressed. That addressment is not because the science isn't there. It's all because of what it takes to really be able to reach patients where they're at today in that OB-GYN practice and that well woman checkup. At Myriad, we've always really had the best products. I think there's been never a doubt about that.

Our commitment to science has always been profound and paramount. 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. One of our more successful programs is how do we integrate with their EMR directly, making this so that the same system that they use to order every one of their other pathology tests or imaging labs or doing their patient consultation would be able to click button, go, and order a Myriad test as well. We've made a huge investment in this. Just in the last year or so, we've really devoted that investment around hereditary cancer in particular.

To date, we've integrated with over 900 systems, 42 different vendors. When we do these integrations, it has a provable growth in order volume. It's about a 25% lift in same-store sales before and after the integration. The acceleration of this program is only picking up. We were originally thinking we would go to 600 clinical integrations this year, and we're on pace to exceed that with over 650. About a 35% year-over-year increase in the amount of EMR integrations that we've been able to do. We're only accelerating this further. I think we just recently announced this partnership with Epic. This Epic, the largest EHR provider in the country, over 25% of Myriad's current business is with Epic, over 50% of large health systems, and those doctors with over 25 physicians are on Epic.

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. 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 approvable volume growth. We expect to see that same 25% uplift in these accounts. The integration goes further. It's not just ordering and 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 VCF files as well. 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.

Epic and Myriad working together is making that possible. All that's really feeding into our larger data strategy. When we think about data at Myriad, we really bring it back to our mission. We think about the purpose that we have, the care, the promise that we have for our patient providers, is how to treat that sacrosanct and also how to be able to make that serve ultimately to improve outcomes, to improve treatment. We think about how much that is capable in driving the next generation in precision medicine. At Myriad, we've always 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.

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. We really think about Myriad being a really allowing for the facilitation of this new insights, this new health-driven insights market. Just how this impacts the business is we don't think of 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. That's ultimately our value proposition to the market. We do our 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 unto ourselves.

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. It's about seven million genetic results to date, about two million variant curations, over several hundred thousand low-coverage whole genomes, about 450 samples accessible as well. 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. A lot of that we've collected and we have collected. That's why we're trying to work in partnership with all these different people to bring that together into one unified place. 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 that allow for that risk score for all ancestries. That was something we've been working on since 2017 when 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. That research took about 400,000 patient results that went into that research, making sure every ethnicity was represented to about 10,000 samples. It's really been ingrained 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 in 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 platforms. You can think of things like ENCODE or TCGA or ClinVar, things that everyone's used to, everyone's 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. 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 power data intelligence. 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 and that intimate patient data.

Finally, I just wanna talk about how this has been working in practice. Early this year, just in March, we not only launched the Precise oncology solutions, so the combination of germline and tumor testing, but also our health data intelligence solution on top of that. This was the Precise Treatment Registry, which our goal is to have about 100,000 de-identified patients enrolled within about three years. It's gonna be the combination of both the germline, the tumor, the liquid data. We've already pre-populated that with lots of tumor-normal matched samples.

Today, about 35 researchers from institutions across the country are enrolled in that today. It's actually open to anyone, and 25% are new to Myriad. It's a great way to fulfill on that strategy of increasing adoption of Myriad because we have this open data platform. 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. 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.

With that, I'll turn it over to Dale.

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Yeah. Folks, able to hear me now? I'm sorry. I think we're still getting the mic started. Great. Yeah. 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 for a postdoc in genomics. Was very happy to join Counsyl after that, and then Myriad subsequently after that. I've been with the company for eight years, even though I'm kind of new in this role. We've got some awesome stuff to talk about today, I'm really excited to get to that.

I'm gonna be talking about some developments in GeneSight that are really important to share, and then some new products. Precise Tumor and Liquid, I wanna be talking about our MRD developments of late, and then FirstGene as well. Good, exciting things on the docket. Let's start with GeneSight. Very recently published in JAMA was the largest, pharmacogenomic mental health trial. This is the VA PRIME Care Study. It was a randomized clinical trial. Before getting into the results of that, just want to sort of set the stage for like, you know, what is GeneSight? Why does it matter?

We've heard some of the, like, commercial developments, some of the technical developments, but just sort of on a clinical level. 8.4% of adults in the U.S. suffer from major depressive disorder. That's like one in twelve people. I passed probably several thousand just walking two 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. 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. With each of those transitions, it can take multiple weeks that you're on that therapy.

There's a ton of people suffering from this. They do not get the drug that they need the first time, and transitions among those drugs take a lot of time. 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. That's what it does. It has a huge history of evidence behind it.

I'm gonna be talking about the VA PRIME Care Study. 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. The VA PRIME Care Study is an addition to this legacy. If we now look at what it actually did. It had nearly 2,000 patients. These were U.S. veterans that were ages 18 through 80, suffering from major depressive disorder, who had at least one prior treatment episode, either treatment itself or and/or therapy. These patients were randomized to two 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 four, eight, 12, and 18, and 24. They were tested with the PHQ-9 questionnaire. This is a nine-question form, asks various questions on how they are doing, and you get a score that can range from zero to above 20. All patients enrolled had a PHQ-9 score of at least nine.

What the 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 five or below. There are two co-primary endpoints in this study. This study was published in JAMA. I do wanna just sort of stress that again. Extremely selective journal. Accepts only the most rigorous work. There were two co-primary endpoints. 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. 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 can either be used as directed, may have a moderate gene-drug interaction or a significant gene-drug interaction. When the physician and patient 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 did not have gene-drug interactions. Okay? There was, as you can see in the red, a nearly twofold reduction in people who had significant gene-drug interactions.

Critically, this trial was not interventional and directive, where we said, "You must take a green in therapy." The study was designed by people at the VA. Myriad did not design the study. We were not authors on 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. The answer was that people used these results. This co-primary endpoint was met. Now, the second one was also met and was answering this question. Over a 24-week time frame, does access to GeneSight testing significantly improve the likelihood of achieving depression remission compared to treatment as usual? It does. It does so in a significant manner. In fact, the GeneSight arm had a 28% greater likelihood of achieving remission than the treatment as usual arm.

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. Again, two co-primary endpoints, both met. You can find those results in JAMA. I encourage you to look at it. Development on GeneSight, clinical development on GeneSight does not just end with this study. Internally at Myriad, we are continuing our clinical validity and clinical utility assessment in patients with major depressive disorder, and we're also branching out into other areas. For instance, we're next gonna be verifying the efficacy in treatment of postpartum depression. Just to show kind of why this is important clinically for a second, there are about four million pregnancies. About 10% of them have postpartum depression. 90% of that goes unrecognized.

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 fail to remit. At the end of the day, only about 0.4% of cases of postpartum depression are actually, like, treated fully to remission today. This is a huge opportunity for GeneSight to help these women. 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. Yeah, we're really excited about not just the results from the VA PRIME Study, but also further future developments on Gene

Sight. Okay. Now I wanna pivot to talk about advancements in our oncology space with Precise Tumor and Precise Liquid. 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. Those therapies are developed to do very specific things 'cause they target particular parts of the cell. The person may 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? You want to profile the tumor so that you can understand which of these drugs to take. We can do genomic profiling of that tumor. That helps them select the right therapy. 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. We offer already the molecular profiling test in Precise Tumor for solid samples. With a launch planned 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. You get the same results, but this will just make it easier for physicians to use. You can use it on sample types where a solid sample may be harder to biopsy, and the liquid biopsy would be available. This is being offered in collaboration with Illumina and Intermountain Healthcare. The panel itself has more than 500 genes. I don't wanna just slide past that. That's a big deal.

You know, the some of the established companies such as Foundation in the solid space and Guardant in the liquid space, they do something similar here. The panels are smaller though. This is a larger panel and at the same time, like, what we're looking for are, you know, like a variant in KRAS. With Illumina's partnership, I mean, I'm looking at KRAS too, I can find that variant as well. And similarly, the therapy recommendation that comes from it, this is effectively open material. That KRAS mutation points to a therapy that Guardant knows about just as well as Illumina, us, Intermountain know about and report to patients. Ultimately, you're getting an extremely similar result with actually then a larger panel.

Yeah, again, both of these products can be used in sort of a standalone 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 a shop that offers one or the other. 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. Not only do we offer the tumor profiling, but we also have the germline testing and the leading companion diagnostic for HRD detection. It really just fits into a whole context of care. All of this gets integrated into the portal that Kevin talked about.

We're really excited about bringing this to market soon. 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. Let's talk about that. MRD monitoring is really trying to address two fundamental questions. First, is my cancer treatment working? Second, has my cancer recurred? For the first one, if a cancer treatment isn't working, this may guide a shift to a new therapy, like take a different approach, but it's sure valuable information to have, right? If you also then wanna know if a cancer has apparently gone into remission but has now recurred, you wanna know that as early as possible because that again, sort of opens up your treatment options and makes them considerably more effective.

This is why you do MRD. Now let's look a little bit more deeply at how it works. If we could take a tissue that had cancer and a tumor and sort of zoom into it. Prior to any treatment or surgery, you'd see that there's you know 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've hoped that you've gotten the tumor gone. You know, there's occasionally like I don't care how good your surgeon is, there's usually going to be a couple cells that still persist. That's problematic because over time, those cells can divide and ultimately lead to recurrence of the tumor.

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. 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. You can also identify post-surgery, did you get it all? Like, how much actually remained? There's so much more sensitivity and quantifiability with MRD than with the other, current standard of care.

The way that it works as well, the reason you can do this genomic test is because some cells, as cells die, they basically pop open and their genomes, the genomic DNA gets spit out into the bloodstream. You can take a non-invasive 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 bloodstream. I can take that DNA out of the bloodstream, and if I know what the tumor's genome looks like, I can sequence that DNA and see if there's any tumor DNA from anywhere in the body.

The first step in MRD is to take tumor cells, profile them to find out what their genomes look like. You wanna find out what is different about the tumor genome and the normal genome. 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 wanna find. We can find that at a ton of different locations, though, by doing this complete profile.

You build that profile, and then you use that profile to assess the presence of the tumor at the later stages. That T and G, you look for the T in the genome in the person's blood that you're sampling over time. Okay. Why should Myriad be able to do this? Well, I, yeah, I really wanna 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. 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. Like, we do this every single day. Post-operatively, that residual monitoring where you're now using a plasma sample, that's what we do with Prequel every single day on thousand samples. What we'll be doing with FirstGene, as I'll talk about in a minute. Unlike some labs in the space right now that have to send out various parts of this workflow because they don't do it in-house, like we can do this in-house. We are doing this in-house.

That's really important. We have, yeah, we're doing this right now. Like, this is not just something, you know, in the future that's all hypothetical. I wanna just now give you a little bit of the flavor of what that assay is and show you what we have done. There are two steps. There's the somatic variant identification that I told you about. That's where 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 gonna be looking at the whole genome. That lets you identify so many more sites that you can then track in the blood later.

Speaking of the sites that you're gonna 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. Yeah, really, again, this is a. We're basically going to that sort of next generation of MRD. Like, we have extremely high confidence that this, you know, should work based on the work, the competencies we have, and as I'll show you in a second, that we've gotten it to work well. We assessed the analytical performance of this approach on many, like cell line and patient samples at this point. I just wanna 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. We 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 needed 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. The most concentrated one is 1%. This is one cancer genome for 99 normal cell genomes. Then I just dilute that progressively to the point that I literally have one cancer genome for 100,000 normal genomes. This is very, very dilute at the end of the day.

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 I can observe. Now let's make it harder. Go to 0.1%, and you see that almost 50% of the sites I look at have tumor-derived DNA. Now, as you go to even further, there are still sites that have tumor-derived DNA, even as you go down to like 1- in -20,000 dilution. Okay? It's extremely dilute, but because you're looking at so many sites, you can still see it. You can see that we still have significant sensitivity at the level where competitors go, but even beyond that as well.

We can summarize that again in now a different plot, where we're showing actually the sensitivity as a function of tumor fraction and also the number of sites interrogated. If you look at 16 somatic sites, as is typically done with MRD today, it's performant to 0.1% tumor fraction and then really starts to taper off. As you add more sites, the sensitivity does not fall as quickly, and this will ultimately be really. I mean, this is important scientifically and clinically, but also just from the point of view of reimbursement. There are LCDs and NCDs that have come out on MRD. They're very exciting. Basically, to also benefit from those, you wanna be able to establish non-inferiority. There it is. Not just non-inferiority, but actually superiority by having more SNPs in the assay--m ore somatic sites in the assay, excuse me. Okay, cool.

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 and validation study. We are leveraging our pharma partnerships with companies that we have worked closely with on MyChoice CDx, for instance, to also build out those sample cohorts. We are collaborating with Intermountain Healthcare on a prospective study for MRD. We are planning a large multi-site prospective clinical utility study that will launch in 2023. Finally, we are also working as hard as we can to get to the point that we launch a research use only MRD early in 2023.

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, I'm gonna move on and now finish with some talk about FirstGene. I'm really excited about this product. I wanna set the stage for like what it means, why it's different from some of the other things in our channel. An OB-GYN may see more than 30 women in a day, like eight-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 similarly, then talk about genetics. Genetics is hard to talk about with most people. Doing that 30 times a day, it's a challenge. We have heard this stress from OB-GYNs. This is extremely hard to do. 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. That manifests as sometimes just not getting carrier screening. In fact, that's what we see. A lot of patients don't get carrier screening. The reason is it's hard to talk about.

It takes time to talk about carrier screening. Like, for instance, what they're trying to understand is my child gonna be affected with a severe recessive condition. To have that discussion, the doctor has to talk about, well, we're gonna screen the mother for recessive carrier status, and if she's positive, then we need the father of the child to come in and get screened, even though the father's not a patient of the OB-GYN, so there's complication there. If they're both positive, then you have a 25% chance. Just talking about all these things with patients who don't want to be thinking about genetics necessarily, it's a challenge.

Like, this really crystallized for me in talking to an OB-GYN at 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 don't have time. How can we get that back from them? That's what we wanted to solve. 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 gray circles. A lot of people then, and this is, like will screen positive, but then their partner never gets screened. They really never completed that sort of recessive risk assessment. That's really true for about 50% of pregnancies.

Now, on the other side, there's also about 50% of pregnancies that aren't currently getting a NIPS. Okay? There's really just a massive deficit in genetic care that exists today, like in the OB-GYN channel. 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. As I'm going to describe in a second, it is a four-in-one solution. All right? Let's unpack that a bit. FirstGene is going to include a NIPS for common aneuploidies, carrier screening for common conditions in the mother, fetal recessive status. I'll talk more about this in a minute. It'll look to see if the child is normal, carrier or affected for recessive conditions.

Finally, the fetal-maternal blood compatibility to determine if the mother needs to or cannot take certain immunocompatible drugs. Those are the four things that it's going to offer. It is in one test, though. This is also critical. It is a single blood draw, non-invasively done off of just the pregnant individual. You do not need to know who the father is. You do not need to get the father to get screening. It is just a test on mom. That makes it so much easier. 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 offerings.

What FirstGene will do is test for, I'll talk about this in the next slide, but test for really the basic content, but I just wanna stress that this is really game-changing here in the arena. It eliminates that need for like testing of mother, testing of father, and so on. Ultimately, because we can actually look and see whether the fetus itself is a carrier or affected, like this is much different from that 25% chance of being affected. This is really looking at the fetal genotype. There will be fewer pregnancies ultimately that need diagnostic follow-up and those that undergo diagnostic testing, which they should 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 guideline-recommended. I want to stress the other guideline 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 three 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 bill all three of those on a single FirstGene test. That's important. We offer multiple other versions of opt-in screening. Sex chromosome analysis will be an opt-in. 22q11 microdeletion syndrome testing is available as an opt-in and actually performs extremely well on this test. We're excited to publish that.

Next, for the recessive side, we'll screen for the thalassemias, 10 additional common genes selected to maximize equity in care. Finally, fragile X testing. Then we will be doing RHD copy number analysis for the last part. Okay. Why is this test going to work so well? We are taking the AMPLIFY technology that we've launched in Prequel and porting that to FirstGene. What this does is boosts 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's genome. The more fetal fraction there is, the more genome I have to work with. The test simply just gets better as you move that way.

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. What's critically important about having that higher fetal fraction is the thing over there on the right, that we will have three times fewer samples with inconclusive fetal results. We have some early feedback from the field on this type of test with the 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 with. Okay, we have a clinical study underway to help with this. This will power our various analyses, publications in analytical and clinical validity. We're enrolling more than 500 patients. That enrollment is underway.

From each of those patients, we'll be getting plasma and diagnostic confirmation so that we can compare all these together. We're very happy to be working with our partners at University of Colorado and Austin MFM, and are recruiting more sites as well. I really wanna summarize this here for FirstGene that like it is four-in-one testing but has really some significant benefits. We will have three times 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 two times that 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, three times fewer samples with inconclusive results.

That's huge. Like, a doctor can be confident at 10 weeks that they will get results. Then finally, as opposed to unpacking the assay and running a carrier screen and an NIPS and a reflex and a this and that, by doing it all together, we have comparable COGS for this test as we do for our other tests, so it would be three times lower than unpacking it and try to give you four in one 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 FirstGene, some of them, you know, get Prequel and Foresight.

Basically, they have options available to them, and each one meets their different needs. Just wanted to revisit this. Nicole already showed it to you, but just to, again, like, you know, we've got some cool things on the roadmap, 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. FirstGene, we are looking toward a launch next summer, so this is really, really late in development. It's looking awesome. Our MRD as well, like, is, you know, as I said, moving toward an RUO launch early next year. And yeah. Like, we've got a lot of cool stuff going on. We're moving these into our new facilities, and we're just really, really excited about it.

Yeah, thank you for your time hearing that, and I'm gonna turn it over to Bryan.

Bryan Riggsbee
EVP and Chief Financial Officer, Myriad Genetics

It's-- I don't know who put the batting order, but first I wanna re-orient 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%-12%. I think importantly, when you look at our Q2 results in the first six months of this year on a year-over-year basis, we grew at 9%. 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, gain momentum through 2022, launch FirstGene, MRD as RUO in 2023, and really accelerate growth through the 2022 to 2024 time period.

I'm gonna double-click on a few of these areas and talk about each of our businesses individually. 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 other really exciting things that Dale talked about. The foundational element of our growth rate, 4%-5% contribution from GeneSight, really that's a 20%+ type growth rate over the timeframe of 2022 to 2024. You know, 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 it's meant for patients, we believe we have a test that solves to that, and it's evident in the 40%+ growth rate and 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 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 for the patient and 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'll respond to that need. That's about a 3%-4% contributor to our long-term growth rate. Then finally, really the foundational element of Myriad historically has been our oncology business, and this is one where we've probably 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.

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. This will be a low- to mid-single-digit type growth over the course of the next few years, is our expectation, but really an exciting portfolio of products. I wanna 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. I don't think that even I really appreciated the opportunity that we had when we started this journey a couple of years ago.

The really significant thing here is that we're focusing on all aspects of the revenue cycle process. From the intake process where we start the prior auth, all the way through how we manage things within the billing department, things like creation of denials management committee, where we look 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 course of the project. 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 sending something through in the right way. I think that's really been the guiding principle, and one of the things that I think has allowed us to be most successful is just the fact that we keep the customer at the center of everything we do. 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 of the areas that we really look at regularly. The one in the lower left corner there, the prior auth success rate is really significant. A 15% improvement in your prior auth success rate is gonna have a tremendous impact downstream in terms of 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 do you do what you said you were gonna do?

You know, while we have areas that we're really that we've 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. I highlight those measures on the left here, and then in the center part of this slide just show kinda 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, you know, a lot of times it's not about how much you spend, it's about how you spend it. We've done—I think Kevin and team, as an example, in the tech area, have done a great job of assessing what were 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? 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 of last quarter, access to the capital markets. I believe this gives us a lot of flexibility when you think about things like our investments in operating expense that we talked about, deploying capital in tech and SG&A in order to take advantage of market dislocation. 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. Then just a last slide here to provide a reconciliation, and I'm gonna turn it over to Paul.

Paul J. Diaz
President and CEO, Myriad Genetics

Thanks, Bryan. 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 two years, but we've just really begun that journey. We've laid the foundation for I think great things for our patients, great things for our healthcare provider partners. We have funded all that with the discipline, execution, and operations. It is possible to innovate, grow, and research and make money. We're putting that challenge out to our industry. Where do we go from here really is, as we talked about, whether it's on the commercial side, the R&D side, customer service side, is just the beginning. We've 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. Mainly, I wanna 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. For those of you that have supported us over this transformation, we thank you for your support and confidence in us. With that, I'm gonna ask Dale to come up, 'cause he's twice as smart as I am, to help me with the Q&A today. Let's open it up for some questions. Foster, thank you.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

All right. Can you hear me? Cool. 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 gonna have a microphone going around the room. 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
Senior Managing Director, SVB Securities

Thanks. You know, you looked at now sort of you know I mean across the diagnostic industry. You know I appreciate the 12% organic growth that you're putting out for 2024. I mean when you look at this industry there are a number of products that have delivered significant growth you know over the past few years. If you look at even the sort of industry average it's like mid-teens and maybe just like you know north of that. Why 24% after all of this, you know, transformation and, you know, product launches that you have coming ahead?

Paul J. Diaz
President and CEO, Myriad Genetics

Because, 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 gonna propel and drive growth are just happening, you know, in Q2 and Q3 and Q4 of this year. It has to come together. What I think you've also seen today is a management team that's focused on execution and delivering, and that takes discipline and that takes time.

It's also foundational to an industry that, in a platform upon which we can do M&A, we can launch new products. I think the 12% organic growth rate is achievable. We're going to certainly work hard to exceed that. On top of that, we're gonna be able to deploy capital in an environment where others are really struggling to figure out how to execute and do the basics. I think the leverage in our operating model and our P&L sort of speaks for itself. You know, at 72% gross margins and disciplined. We've done all these investments, and OpEx has only grown 6%-8% in terms of our guidance. That's really important. A lot of change and reprioritization.

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.

Puneet Souda
Senior Managing Director, SVB Securities

Okay. Just a follow-up for those listening on the call. I'm Puneet Souda, SVB Securities. Just, you know, 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, 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, you know, product adoption is gonna really depend on the clinical, you know, clinicians taking this data and more importantly, taking the clinical data and those outcomes and taking action on those.

I mean, that might take a few years to just get those publications out, given the timelines that you're projecting. You know, how should we think about the sort of adoption of these new products in a fairly, you know, competitive market?

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Sure.

Puneet Souda
Senior Managing Director, SVB Securities

Thank you.

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Yeah. Like, first thing we'll launch, I'll just talk about that one as an illustrative example. Like, with, like, we will 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, too, 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.

I feel very confident that not just with the validation paper that will come out, like, with the launch, but also with ones, like, really in short order thereafter, because we have a lot of, like, 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. Like, seriously, like, I've been in the field a ton of times, talked to these doctors, to these counselors, and like, having things be easier is what they want. I think that this really achieves that.

It would be much harder if this were some totally different new type of screening. It's actually close enough to be comfortable, but then easy to use. I think the adoption will be quick.

Paul J. Diaz
President and CEO, Myriad Genetics

I just think we're still in the early innings here. I 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. You know, 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. 'Cause as you've seen, our ASP in prenatal has grown. Our COGS are managed really well. Nicole and the team have just done a great job. I think that's what it's gonna take to have a sustainable long-term growth model and a profitable company.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

Thanks, Puneet. Dan?

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

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

Paul J. Diaz
President and CEO, Myriad Genetics

Yeah. Again, the 20% growth rate is much slower than we're growing right now. Again, we wanna have realistic expectations here. The market demand is huge, as Mark talked about. You know, adding 2,000 to 3,000 new providers every quarter. We think that the PRIME study just allows us to engage with payers again to expand coverage. We think we're, you know, in the early stages. Yeah, 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.

Again, given the size of the market opportunity, tragically, as Bryan mentioned, the extent of mental illness in the country today, coming out of the pandemic, you know, we think there's plenty of growth opportunity here to maintain that 20%+ growth rate, with really modest expectations about expanding coverage. We think we're gonna 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, you know, we're gonna be very disciplined about deploying capital, and whether it's tuck-ins or other opportunities that present itself. Having done a fair amount of M&A over the years and pretty successfully, you know, it is about integration, about culture and people and process.

I think we've built the foundation to do that, which I think is differentiating in the marketplace. The industrial logic of M&A at a big scale in this industry is not clear to me yet. We're gonna be pretty careful about that. Certainly, we're not gonna jeopardize our mothership by bringing other people's problems into our house. You know, that will limit some of the M&A as well. We'll certainly be opportunistic when we think we can add something to our platform or to our product lines that is differentiating. Thanks, Dan.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

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 the pace of payer reimbursement? Does ASP need to go lower in order for that reimbursement to uptake?

Paul J. Diaz
President and CEO, Myriad Genetics

We're engaged in a lot of conversations with payers right now, and certainly the clinical validation is incredibly supportive. We're prepared, you know, 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 healthcare. A lot of people have been burned that way. At the same time, I think we've got, you know, our costs in a way that we can be more expansive, and whether it's in managed Medicaid plans or others. We've entered into a few value-based contracts that are just sort of in the early stages.

Again, the 20% growth is not predicated upon some big signing of a payer contract, but we do think there's gonna be opportunities there, and we're excited about that over the next couple of years.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

Great. Jack?

Jack Meehan
Equity Research Analyst, Nephron Research

Thank you. 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 two big coding changes which are gonna impact 2023. I just wanna be clear, do you think you'll be profitable next year?

Paul J. Diaz
President and CEO, Myriad Genetics

We're gonna be profitable coming out of this year.

Jack Meehan
Equity Research Analyst, Nephron Research

Okay.

Paul J. Diaz
President and CEO, Myriad Genetics

To be clear.

Jack Meehan
Equity Research Analyst, Nephron Research

Great.

Paul J. Diaz
President and CEO, Myriad Genetics

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. We have a high level of confidence in terms of those things and have worked through that as we've talked about, you know, offline, Jack.

Jack Meehan
Equity Research Analyst, Nephron Research

Okay. Second question is, you have the VALID Act that's been working through Congress. Historically, pharmacogenetics has been an area of focus for the FDA. Just curious how you handicap the potential risks if GeneSight were regulated. What changes would you make to the commercial strategy or the test?

Paul J. Diaz
President and CEO, Myriad Genetics

Yeah. As you know, from years back, pretty active in policy and in D.C., so we've been staying very close and working with our association partners. We actually think that VALID Act 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. 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. We've done that across all of our product lines to really be very careful about the statements we make and the assertions we make about the clinical validity of our products.

Certainly it's an area we're gonna stay close to, but right now, generally, I think companies like ours that have had success in reimbursement, success with the FDA, success with New York State. 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. You know, not many companies in our industry have the regulatory history and success that we've had. Even just recently with the FDA moving NovaSeq transitions through the FDA for our companion diagnostic product. 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.

You know, we'll continue to engage in that, but I think that's a strength of the company that we can continue to build on. Thank you.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

Dave?

Dave Delahunt
VP, Goldman Sachs

Hey, guys. Dave Delahunt, Goldman Sachs. Thanks, Paul and team, for hosting us today. You've shown really strong results with the 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
Chief Scientific Officer, Myriad Genetics

Yeah. Well, I mean, the postpartum depression is, you know, really a key place where we plan to sort of use even just the current GeneSight test to understand how well it would predict, you know, the utility for, like, drugs and during that period. That's one. Then, yeah, absolutely, there are ways to branch out into other indications. You know, really fundamentally what GeneSight does is we look at variants 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. We work 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, you know, your GeneSight report to date, but you could easily integrate that with other, you know, FDA-approved drugs in other indications. Really the platform is extensible, and that is definitely something we're evaluating. Yeah.

Paul J. Diaz
President and CEO, Myriad Genetics

I think more broadly, you know, strategy's about choices and about execution. 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 coloring outside the lines, is does this fit within our mission? Is it actionable? Can we make money? And does it serve a patient need? You know, we're just trying to put this through a lens of something that we can get through to the other side. There's certainly a lot of other areas we're looking at that we're excited about.

Today, we just sort of showcased 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
Chief Scientific Officer, Myriad Genetics

I just think it's great that on a technical level, it should work, 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. Yeah.

Paul J. Diaz
President and CEO, Myriad Genetics

Yeah. Just generally, you know, the company had muscles that had atrophied and we're, you know, just whipping it back into shape and getting back out on the field. Sorry for the sports analogy.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

Andrew.

Andrew Cooper
Senior Equity Research Analyst, Raymond James

Andrew Cooper, Raymond James. Thanks for the question. Maybe thinking a little bit longer term and on MRD maybe for Dale. You know, 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, you know, commercial product, I understand it's early, but-

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Yeah.

Andrew Cooper
Senior Equity Research Analyst, Raymond James

... how do you think about what the structures of those trials need to look like? What the sort of prioritization of the data you wanna show to get to commercial markets, whether it's by indication or-

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Right.

Andrew Cooper
Senior Equity Research Analyst, Raymond James

... certain use cases, just, how you think about that and what the timelines we should think about are would be great.

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Yeah. Like, to use Paul's phrase, right, 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 first? We're very deep in thinking about that. Yeah, how many samples do you need to power those studies? Yeah, we're currently evaluating all of that. But our focus is really getting the RUO product, like, out and available. That becomes a catalyst for that kind of clinical engagement. You know, having it in the hands of our pharma partners and also just our clinicians who are, you know, interested in using a more comprehensive, more expansive test, like it really, it's sort of a positive feedback loop to then get that same clinical engagement.

Paul J. Diaz
President and CEO, Myriad Genetics

Yeah. Look, that's an important part. Look, we've got some great work that's happened with other companies that have led the way here. But we're in the early stages at MRD in terms of adoption. But quite frankly, as we've seen with people following us, you know, in hereditary cancer, you know, 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 MyChoice beyond ovarian is a huge opportunity in as we partner and it sort of a similar thing. How can we move from research only into clinical studies into reimbursement?

The path is much shorter for us, than it would have been for others who led the way, thankfully, over the last couple of years. In a market that's still 2%-3% penetrated, I mean, what you heard from Dale is this huge patient opportunity to change how we deal with, treat, and monitor cancer. You know, we may be two years behind, but we're gonna catch up quickly in a place where we have a right to play and a right to be successful. Yeah, we've got a lot of work to do, but we've caught up a lot in two years, I think most would acknowledge.

Andrew Cooper
Senior Equity Research Analyst, Raymond James

Great. Just quick follow-up, thinking about that RUO launch in early 2023. Any, you know, notable kind of financial assumptions involved in the 2023, 2024 guidelines you're talking about from a pharma perspective?

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Zero.

Andrew Cooper
Senior Equity Research Analyst, Raymond James

Perfect. Thank you.

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Yeah.

Paul J. Diaz
President and CEO, Myriad Genetics

Is zero clear?

Andrew Cooper
Senior Equity Research Analyst, Raymond James

Mmhmm.

Paul J. Diaz
President and CEO, Myriad Genetics

Thank you.

Nisarg Shah
Equity Research Analyst, Bank of America

Hi, Nisarg Shah with Bank of America. Wanted to start off on MRD. The space is pretty competitive. You know, you've seen companies like Personalis doing tumor-informed MRD whole genome sequencing with 1,800 loci. In your presentation, you guys mentioned, you know, the 500- loci approach. You know, why is that gonna be better? Is that gonna improve, you know, sensitivity? Are you guys gonna offer better workflows, turnaround time, a better price point? Because, you know, if the argument is the more loci, the more accurate, then, you know, why wouldn't people go with the other approach?

Paul J. Diaz
President and CEO, Myriad Genetics

Well, onto the business question, because 82% of the oncologists 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
Chief Scientific Officer, Myriad Genetics

Yeah. Yeah. I think in terms of the number of sites choice, like that is still flexible. This is one of the reasons you launched in RUO and kinda 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, you know, 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 yeah, we'll see where the clinical need is. Like technically, it's effectively trivial to scale up to any number of variants that we can identify in the genome.

Nisarg Shah
Equity Research Analyst, Bank of America

Got it. That makes sense. What's your view on tumor-naive approaches such as, you know-

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Yeah.

Nisarg Shah
Equity Research Analyst, Bank of America

... Guardant, GRAIL, DELFI, for example?

Dale Muzzey
Chief Scientific Officer, Myriad Genetics

Sure. Yeah. I think they're very interesting and we, like, I do wanna be clear, we do have interest in that and like, you know, we'll look at that ourselves. I think that, like, we feel, and we did evaluate the various different approaches, that a tumor-informed approach really will be more sensitive. Like, 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 than you would be able to do with this bespoke one.

Just on an intuitive level, if you literally have probes that are looking at exactly the tumor's genome at like 500 or 1,000 sites or something like that's simply going to be a more sensitive approach than something that is really not like actually tuned to the tumor itself.

Paul J. Diaz
President and CEO, Myriad Genetics

Yeah.

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

I think we have time for one more question.

Paul J. Diaz
President and CEO, Myriad Genetics

Great. Anything else?

Foster Harris
Senior Associate of Investor Relations, Myriad Genetics

No, that's it. Covered.

Paul J. Diaz
President and CEO, Myriad Genetics

All right. Good. Listen, thank you all that 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 a shout-out to all our teammates. You know, people have worked really hard. You've seen a lot of that progress. We've got a lot more work to do, but we really are excited at our future and our ability to really take advantage of all the incredible science that's 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. Thanks again for participating today and we look forward to keeping the discussions going. Thank you.

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