Myriad Genetics, Inc.

Good day and thank you for standing by. Welcome to the Myriad Genetics Third Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Matt Skylow. Please go ahead.

Good afternoon, and welcome to the MIRI Genetics third quarter 2025 earnings call. During the call, we will review the financial results we released today, and afterwards, we will host a Q&A session. Our quarterly earnings release was issued this afternoon on Form 8K and can be found on our website at investor.myriad.com. I'm Matt Scalise, Senior Vice President of Investor Relations. On the call with me today are Sam Raha, our President and Chief Executive Officer, Ben Wheeler, our Chief Financial Officer, and Mark Verratti, our Chief Operating Officer. This call can be heard live via webcast at investor.myriad.com and a recording will be archived in our investor section of our website along with this slide presentation. Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements. I will now turn the call over to Sam.

Thanks, Matt. Good afternoon, everyone, and thank you for joining us today. I'm pleased with our results, the actions we're taking to execute against our updated strategy, the stepped-up urgency and rigor, and how we operate, leading to growing momentum as we head into Q4 and 2026. Let me start with our results. We generated revenue of $206 million, which decreased 4% year-over-year, When you exclude previously discussed headwinds, including UnitedHealthcare's decision on GeneSight and the divested European EndoPredict business, our business was stable with Q3 of 2024. In addition, there was a material 8.6 million prior period contribution in the third quarter of 2024 that did not repeat. Factoring in these previously discussed headwinds and the prior period change of estimates, year-over-year growth was 5%. In terms of testing volume, our solid results were supported by continued strong volume growth for MyRisk and Oncology at 16% over the year-ago quarter. We also saw volume growth for MyRisk for unaffected at 11%. This is a meaningful improvement from past quarters and reflects our ongoing efforts to enhance the customer workflow, including EMR functionality. Mark will provide additional color in his section, but certainly MyRisk continues to see positive demand in the market and supports our profitable growth journey. Gene site volume grew 8% year-over-year, accelerating from the first half of 2025 as our commercial organization continued to focus on medium and higher volume accounts. Prolaris demand continues to be stable and test volume growth up modestly year-over-year. As expected, volume growth for our legacy prenatal products, Prequel and Foresight, while flat year over year, showed improvement from second quarter as we continue to increase the volume of testing customers affected in Q2 challenges and add new customers. Turning now to profitability. We generated strong adjusted gross margin of 70.1% in third quarter and closely managed our discretionary spend as reflected in our adjusted OPEX fund. Ultimately, we reported a healthy adjusted EBITDA of $10.3 million. I'll talk about our growth strategy in a moment, and Ben will talk later about our reiteration of the 2025 financial guidance. Moving to the next slide, I want to spend a few minutes reviewing our updated strategy and why we believe we will be able to deliver accelerated profitable growth in the years to come. Our first strategic pillar is the focus on the cancer care continuum to accelerate growth. We will achieve this by leveraging and growing volume of our leading hereditary cancer test, MyRisk, and also by expanding our portfolio to include other cancer screening, diagnostic, and monitoring tests. Our second strategic pillar reflects our recognition of the opportunity to meaningfully grow prenatal health and mental health revenues at or above market growth. We believe we can achieve this by leveraging recently launched products and strengthening our commercial execution while maintaining a disciplined level of investment and resources in these areas. Our third strategic pillar is about our focus and commitment to delivering sustained profitable growth by continuing to leverage our industry-leading gross margin profile and maintaining financial discipline. Now, one can say, what's different about this strategy from before? Well, there are five primary differences. First, it's about intentional focus and prioritization of funding and resources on the cancer care continuum opportunity. Second, for our cancer care portfolio, it's about going beyond our strong hereditary cancer and HRD positions and also offering tests for other relevant high-growth applications, including therapy selection and MRD. Third, it's about strategic partnerships. Unlike before, we see an increasing opportunity to serve attractive market applications in a timely manner by complementing Myriad's differentiated capabilities by leveraging select partnerships. Next, it's about having the right team with deep domain knowledge and proven experience in cancer, diagnostics, genomics, and commercial execution to win in a dynamic market. And with the leaders that have joined Myriad, like Lou Welabaugh from Biopharma and CDX Services, Hussein Korsmar for Oncology R&D, Vishal Sikri for Product, and Brian Donley as our Chief Commercial Officer, I'm confident in the strength of our overall team. Finally, it's about strengthening execution excellence. Thinking and acting with elevated urgency, leveraging industry best practices for key processes, and executing with rigor and discipline. On the next slide, let me provide updates on the progress we're making on the cancer care continuum strategy, many of which will be important catalysts for accelerating growth in 2026 and beyond. We're on track to launch our updated MyRisk test this month in November, and we expect this to support strong MyRisk growth in 2026 and beyond. In terms of offerings for other attractive high-growth cancer care applications, in September, we entered into a collaboration with Sophia Genetics that enables us to provide pharma customers with biomarker validation and CDX development services using a leading liquid biopsy-based therapy selection assay. We're making steady progress on our ultra-sensitive tumor-informed precise MRD test. We're on track to start offering the test for clinical use in the first half of 2026. The first indication will be stage 2, stage 3 breast cancer in the neoadjuvant setting. In addition, Myriad will present three MRD studies at the San Antonio Breast Cancer Symposium next month, two of which were just accepted this past week as late-breaking abstracts. We'll also be presenting six additional abstracts and other oncology-related studies for a total of nine abstracts at SABCS. We're also on track to launch our first Polaris prostate cancer test that combines the power of molecular and AI, based on our partnership with Cathomic in the first half of 2026. I expect to have more exciting news regarding strategic partnerships to share with you over the coming months. Also, I want to take a moment to share that we are making changes in our organizational design and investments to help improve customer experience, gain market share and reduce operating expenses as a percentage of revenue going forward. The actions we are taking will in part result in the reallocation of headcount and funding to support growth in the cancer care continuum. This will include the meaningful expansion of our commercial team and increased funding for commercial launch and market activation programs to support the exciting new products that I just updated you on, as well as increased funding for MRD R&D. On the next slide, let me provide brief updates on our second and third strategic pillars. In June, we commenced early access for our first gene multiple prenatal screen that we believe will support growth in our prenatal portfolio volume profitability and has significant potential to expand the prenatal market over time. Mark will provide more details on our experience during our early access and how this supports our optimism for strong commercial launch in 2026. Regarding mental health, we expect to continue growing revenue for our market-leading gene site test by concentrating high-value accounts, leveraging state biomarker laws, and building on the success we've seen over the past two quarters. In alignment with our overall strategy, we will achieve this growth for both of these businesses while maintaining disciplined capital deployment. The third strategic pillar is about our focus and commitment to delivering sustained profitable growth. The organizational redesign and efficiency actions that I shared with you earlier will support our ability to accelerate top-line growth while ensuring we grow operating expenses less than revenue. Before I turn the call over to Mark, I want to welcome our new CFO, Ben Wheeler. Ben certainly isn't new to many of you, and with 14 years of experience at Myriad, he has the knowledge, skills, and demeanor that make him our ideal CFO. Personally, I'm thrilled to partner with Ben in this important time for the company. Now, let me hand it over to our COO, Mark Verratti. Mark.

Thanks, Sam. Turning to oncology. In the third quarter, total oncology revenue was $81.8 million, a decline of 1% over the third quarter of 2024. I would call out that our MIRIS test continues to gain share with volume growth in the affected market of 16% and 11% volume growth in the unaffected market in the third quarter year-over-year. Shifting to prostate cancer, Polaris revenue in the third quarter grew 3% year-over-year on positive volume growth and a continued improvement year-to-date. As mentioned on previous calls, we are investing in the commercial channel and other programs to grow and regain share in this market. As an example, Myriad is on track to be the only company that will offer AI, biomarker, germline, and tumor profiling testing when we launch our first AI-enabled Polaris test in the first half of 2026. I'm also excited to call out a strategic collaboration we recently announced with Sophia Genetics. We expect this collaboration to support the development and global commercialization of comprehensive companion diagnostic solutions for our biopharma partners with the potential to add an important product offering to the myriad menu and support the growth of our companion diagnostic programs. We look forward to providing an update on our progress going forward. Lastly, I want to call attention to our September press release regarding our latest MRD publication in Lancet Oncology. Our tumor-informed, ultra-sensitive, precise MRD test showed clinical value in patients with ogliometastatic clear cell renal cell carcinoma, which is a very low-shedding tumor and requires an MRD test in the ultra-sensitive range. Importantly, the study showed that in patients who were precise MRD negative and maintained on metastasis-directed therapy and not on systemic therapy had an overall survival rate of 94% at two years and 87% at three years. The data is extremely promising because it highlights that using an ultrasensitive test like Precise MRD can potentially identify specific patients on MDT who can delay systemic therapy and all of its associated side effects based off of their ctDNA status without sacrificing overall survival rates. As Sam mentioned, we are excited and expect to start offering our ultrasensitive Precise MRD test for clinical use in the first half of 2026. Expanding on MI-RISC. With our current momentum in hereditary cancer testing, now is a perfect time to launch Myriad's expanded MI-RISC with Risk Score panel. The team is excited to get this new test in the hands of our customers and drive further growth and build on our leadership in this $6 billion market. This new panel adds 15 actionable gene targets and is the only panel to meet both NCCN high-risk assessment and ASCO's strongly recommended guidelines. I can't overemphasize that point enough, as guidelines impact provider decisions. In fact, many of our medical oncologists and genetic counselors, those that work with pan-cancer test populations, have been very interested in our expanded panel in order to not miss any patient who may have a hereditary cancer syndrome that may impact treatment. Now moving to our women's health business. In the third quarter, women's health delivered revenue of 85.2 million, an increase of 3% over prior year period. We're pleased to see incremental positive momentum in hereditary cancer testing in the unaffected market with revenue growth of 4% and volume growth of 11% year over year. This improving volume growth trend is particularly important as it reflects EMR-related workflow improvements put in place earlier in the year. And in September, we've completed the integration of our My Gene History Assessment into Epic as a way to better identify patients that qualify for hereditary cancer testing and improve the provider experience so we are optimistic about the potential for continued momentum. We also remain confident about the ongoing progress from breast cancer risk assessment programs that enable providers to rapidly identify patients who qualify for additional screening. We continue to see positive momentum at these sites and expect to make further investments in our commercial capabilities to accelerate this program through Q4 and into 2026 to fuel growth in my risk volume. As for prenatal testing, in the third quarter we saw a modest rebound in volume growth from the second quarter and expect this trend to continue. As Sam mentioned, we introduced our multiple prenatal screening test, first gene, and expect a commercial launch in 2026. This test provides added insights to providers and has the potential to expand the overall addressable prenatal testing market. We are pleased with our turnaround times, assay performance, and early customer feedback. Now, turning to mental health. In the second quarter, the team generated gene site revenues of 38.7 million on volume growth of 8% year over year. We continue to drive expansion of the ordering provider base by achieving a record number of ordering clinicians over 37,000 in the third quarter. While quarterly revenue continues to be impacted by UnitedHealthcare's coverage policy change in January, we submitted additional data in Q3 and expect to review this quarter as part of their typical review cycle. While we continue to work with United to achieve a successful outcome for both parties, we continue to make forward-looking decisions assuming the status quo. We are excited and proud of our payer markets team for securing positive coverage policies across nine states for gene site year-to-date related to biomarker laws. Most recently, the California Medicaid program, Medi-Cal, added gene site with a September 2025 effective date. In addition, we are seeing benefit from optimizing revenue cycle workflows to maximize reimbursement. I will now turn the call over to our new CFO, Ben Wheeler. Thanks, Mark.

I'm especially pleased to join you today as Myriad's Chief Financial Officer. Myriad is a company whose mission I've been fully committed to for the last 14 years, and it's an honor to now represent our team in this role. While this is my first earnings call as CFO, I've had the opportunity to contribute to many of them over the years. Let me start with a recap of our third quarter consolidated financial results. For the third quarter, we reported revenue of $205.7 million, a decline of 4% year over year, with test volumes up 3%, but average revenue per test down 7%. The growth in third quarter test volume reflects improved execution across our portfolio. As Mark pointed out, the hereditary cancer testing portfolio saw strong volume growth in the third quarter, increasing 11% year over year. Our mental health business saw volume growth of 8% year over year as the team continues to hit its stride following organizational adjustments made earlier in the year. The re-acceleration in both unaffected hereditary cancer volumes and gene site volumes represent important proof points in our improving commercial execution. The year over year headwind in average revenue per test this quarter primarily reflects three factors, two of which we've discussed previously. First, we're lapping a difficult comparison against third quarter of 2024, which included an $8.6 million positive prior period change in estimate versus an immaterial amount this quarter. Second, we continue to see the impact from UnitedHealthcare's policy change with respect to gene site coverage, which took effect in January 2025. The third factor reflects modest shifts in payer mix within our hereditary cancer portfolio, that had a larger than expected impact on average revenue per test in the third quarter. As you know, payer mix can be quite fluid, and it's something we actively work to manage through our commercial targeting and revenue cycle and payer markets teams. Our fourth quarter assumptions for average revenue per test take these third quarter dynamics into account. This quarter, these three factors have masked our strong ongoing work by our revenue cycle, payer markets, and clinical development teams as well as the generally stable reimbursement landscape. As we mentioned last quarter, we're encouraged by the progressive stance some payers are taking towards ECS coverage, even in the absence of updated ACOG guidelines, and the ongoing traction we're experiencing with health plans that have implemented medical policies that conform to state biomarker legislation. We expect these positive trends to continue supporting prenatal and gene site reimbursement in the quarters ahead. My last comment on third quarter revenue. Sam referenced an underlying third quarter 2025 revenue growth rate of 5% after taking into account the impact of certain items on our Q3 2024 baseline. Namely, UnitedHealthcare's net impact on gene site of $7 million, the divestiture of our EndoPredict European business of approximately $1 million, and the $8.6 million impact from prior period change in estimate and the third quarter of 2024 that did not repeat this quarter. By calling out these items, we're able to show what we consider to be a clear view as to Myriad's underlying performance trends. Even with these headwinds to third quarter revenue growth, we maintained adjusted gross margins of approximately 70%. This reflects a favorable test mix, continued operational efficiencies in our labs, and underscores the strength and scalability of our business model. Third quarter adjusted operating expenses decreased by a million dollars year over year, reflecting continued cost discipline across SG&A. We remain focused on maintaining the right balance between investing for future growth and driving profitability with a deliberate effort to allocate resources to our highest strategic priorities. Next, I'll speak to Merit's profitability and liquidity. We generated $10.3 million of adjusted EBITDA, and $18.6 million in adjusted free cash flow in the third quarter. Our strong adjusted free cash flow in the third quarter reflects the timing of collections from certain payers, as we noted on our second quarter call. And we don't expect this level of free cash flow generation to repeat in the fourth quarter. That said, the combination of our strong gross profit base and positive adjusted EBITDA demonstrates the leverage inherent in our operating structure and the profit and cash generating potential of the business. Lastly, we have a solid balance sheet and access to $220 million in capital. Next, I'll talk about additional steps we are taking to drive business results. As part of our strategy to drive sustained profitable growth, we have launched a multi-year program to invest more than $35 million in strengthening our commercial capabilities with a focus on the cancer care continuum. This investment will be primarily funded through the company's streamlined structure continued emphasis on organizational efficiency, and disciplined capital deployment. Three core areas of future investment include, one, the expansion of our commercial organization. This includes meaningful growth in our field sales team and optimizing the structure and management of target territories. Two, the enhancement of commercial capabilities and tools to support new product introductions and commercial excellence. And three, increased funding for strategic R&D programs, which includes current and future clinical studies for MRD as well as other areas. Part of our organizational redesign is to move to being organized functionally going forward. With this, we're reducing management layers and eliminating other roles. We believe these important actions will accelerate revenue growth and generate long-term value. Before I conclude, I'll cover our full year 2025 financial guidance. Based on our Q3 performance and our expectations for the remainder of 2025, we're reaffirming our full-year financial guidance, which includes a revenue range of $818 to $828 million, a gross margin range of between 69.5 and 70%, an adjusted OpEx range of between $562 and $568 million, as well as an adjusted EBITDA and adjusted EPS guidance ranges of between $27 and $33 million and a loss of two cents and a gain of two cents for the full year 2025, respectively. Now let me turn the call back to Sam.

Thanks, Ben. Considering Breast Cancer Awareness Month in October that just passed, I wanted to take a moment to reiterate Myriad's longstanding commitment to supporting patients and healthcare providers with breast cancer risk assessment and medical management tools. we will continue investing in tests that help improve breast cancer care. As we noted earlier, our MyRisk with Risk Score test is considered an industry gold standard, and we're looking forward to launching the expanded panel later this month, and then in the first half of 2026, to launching our first precise MRD test for breast cancer. As for the third quarter, we demonstrated good progress across our commercial, operations, and development teams. Strong volume growth for a number of our tests supported this quarter's performance, while our overall gross margin remained resilient and among the industry's best. This, combined with our ongoing focus on operation leverage, allowed Myriad to drive another quarter of positive adjusted EBITDA while investing for future growth. With clear actions now being implemented to support the execution of our updated growth strategy, the Myriad team is energized to deliver on our mission to advance the health and well-being for all, positively impacting the increasing number of patients while driving accelerated profitable growth. I'll now pass the call over to Matt for Q&A. Matt.

Thanks, Sam. And as a reminder, during today's call, we use certain non-GAAP financial measures. A reconciliation of the GAAP to non-GAAP financial results and a reconciliation of the GAAP to non-GAAP financial guidance can be found in our earnings release and under the investor relations section of our website. Now we're ready to begin our Q&A session. To ensure broad participation, we're asking participants to please ask only one question and one follow-up. Operator, we're now ready for the Q&A portion of the call.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile our Q&A roster. And our first question will be coming from Puneet Salda of LeeRink Partners. Your line is open, Puneet.

Yeah, hi, guys. Thanks for taking my question. Maybe, Sam, a higher-level question here. With the commercial focus and the investment you're talking about, can you talk a little bit about what are some of the offsets and the savings that you're able to manage, you know, as you go into 2026? How should we think about growth as a result of these investments And obviously profitability has been, as you pointed out, an important piece of the story. So how should we think about adjusted EBITDA in 2026, just given the focus in pushing for growth? I just want to understand a little bit in terms of the growth versus profitability focus that you have emerging on this call.

Yeah, Puneet, thank you very much for the question. And let me start, and then, Ben, I'll turn to you to add more color. So first, let me reaffirm, embedded in your question, we are committed to profitable growth going forward and being able to accelerate that, as you know, we've talked about, by focusing in on the cancer care continuum. So the actions that we took related to the organizational redesign and changes in our investment focus Those actions including, and Ben spoke to this already, reorganizing in a way where we believe we're going to be able to serve customers, be able to increase our win rate. This includes, in some instances, where we've taken out multiple layers of management. We made other choices on positions that we've deemed to be less critical than other ones that are related to having more feet on the street, if you will, to compete and particularly timed with new upcoming product launches that we have that you heard me talk about. So between that and reallocation of investments, we are committed to growing revenue faster than we grow operating expenses. So that part of the profitability along with growth remains intact. I said a lot there, Ben. What would you add?

Yeah, I would just say that the actions and the focus is absolutely consistent with the strategy as we focus on the cancer care continuum and we want to grow revenue at an accelerated rate and we want to do it profitably. We felt like we could rebalance the organization and focus on growth in the cancer care continuum by expanding the sales footprint and focusing on tools and also R&D to support that. And we believe that we can do that. Okay.

And then a question on the NIPT side. Just wanted to get a sense of it does look like you came in software versus us and consensus as well. Just wondering if there was any share shift that you're seeing in the market. I know you talked about that you grew sequentially, but just wondering, given new entrants in the marketplace, mother-only blood draws with a competitor, others that are pushing it more aggressively into market, maybe just help us understand what you're seeing on the market end versus Myriad's position and if you're seeing any share loss.

Yeah, so Pradeep, thank you for this question too. And you might recall, we had some challenges that were related to our operational execution matters that were in Q2, which we've fully addressed. And we had predicted that it would take us multiple quarters to gain back to the level of growth that we'd expect, right, to be able to go at or above market, which means at least in the single digit for volume, if not higher, because we do have the new products, which we've seen good traction from, be it a prequel at eight-week gestational age, Foresight with the expanded carrier screening, and most recently we've also added F8 and FXN. So we're actually, we have seen improvement where we actually decreased in volume, I think, seven percentage points last quarter and we talked about volume being flat. Now, are we happy with flat? Heck no. We want to go back to being able to grow at or above market, but we're pacing actually exactly as we had anticipated and we had kind of shared with you. Now, are there others that are growing and that are coming to market? Yes, that's a fact. You know, I'm not commenting on that, but we are, by the way, excited about the opportunity to accelerate our own growth with First Gene, which Mark talked about in his comments, which will be the combined two-in-one screen for NIPS together with carrier screening.

And our next question will be coming from David Westenberg of Piper Sandler. David, your line is open.

Hi, thanks. I'm going to actually follow on Puneet's question on the NIPT business. Can you give us some color on the friction on the new ordering management system, why that is lasting into this quarter and why that wouldn't maybe necessarily end in this second quarter? And then just in terms of that market dynamics that he kind of discussed here, Can you talk about how single-gene NIPT would play a role in kind of maybe some of the growth that you'd receive next or see next year? Do you expect any data differences, particularly after you complete the connector study, and you maybe can talk about some of those long-term differences you might see versus some of those competitors? And I'll have one quick NIPT follow-up. Thank you.

Yeah, thank you, Dave. Appreciate the question. Let me start, and then I'll invite Mark into answering with me here. Again, we wish we can just snap our fingers and gain back all the customers and the volume. I think we described this previously. The matter is that many of the high-volume customers that we have, they are working with us and a couple of other providers for these prenatal tests. And when we work through our, you know, when we have the challenges, which again have been completely addressed, that led to some shifts in volume away from us. So we are improving on that. That's why we've gone again from 7% volume decline back to flat in terms of our volume. Again, that's not where we want to be. We're right on track to being able to now show volume growth in the coming quarters. It just takes time to regain and also to add new customers, and we have done that. It's something that you just can't make happen much quicker than that. The second part of your question is related to First Gene. Again, our screen that combines NIPS together with expanded carrier screening. And we are excited about that, Mark. Maybe you can talk a little bit about both what we've seen so far as well as why we think it's going to help us expand the market.

Yeah, sure. Thanks, Sam. Look, I think we knew when we started developing First Gene that there were a couple of challenges within the carrier screening space. Number one is Providers just didn't have enough time to really talk about all of the benefits. And there was a little bit of complexity in terms of ordering the products. Number two, we knew that only 30% of the time fathers were also getting screened. And so we knew that there would be an advantage of having a single test where you only need to test the mother and then have the ability to look at the fetal recessive status. So since then, obviously some competitors have entered the space and they've had success. So if anything, that's just validated what we already knew and has given us some greater conviction around the product that we're going to be bringing to market. We know that our product is going to be competitive from a scientific clinical perspective. Based on the footprint that we currently have, we're excited to be able to bring it to our providers. And so we think we will have a very, very competitive test. We'll have lower gross margins moving forward than our current product. So we are excited to be launching that next year.

And Dave, you had asked as part of that, yes, we believe this will help expand the market, the market opportunity for us and to accelerate our growth, not relative to the 0% volume growth, but relative to being at or above market. So beyond what we really were previously, we should be getting back to growing faster than that.

Got it. I just want to maybe ask one more on just kind of revenue opportunity growth from an ASP perspective in the coming years. Do you think that there's a, can you remind us if you're getting paid for RDH, when do you think you could get that, see that happen? Any update on ACOG micro deletions or expanded care screening? And then lastly, on that single gene NIPT offering, as I understand, you would be not, no longer receiving the father, or no longer running a father sample. Is there a chance to go back to reimbursement in the future for an additional reimbursement for that, given the fact that you are saving the system money by not getting the father or testing the father. Thank you.

Yeah, thank you, Dave. I think you had quite a number of important questions built into there. First, let me just provide some facts on that. what we provide today does not have RHD. So we're excited that when we actually launch this product that RHD will be included in our first gene offering. In terms of ACOG, you know, we remain intrigued and interested and fully ready to catch the wave when ACOG guidelines are introduced. you know, important point related to ASP there. We have seen a number of payers in advance of that starting to see the value of the fuller expanded carrier screening and starting to reimburse for that. So that's good news. We expect that to continue as it is. Mark, do you want to speak to maybe the third question is related to opportunity to father? Reimbursement.

Yeah, look, I think we will, as we continue to generate clinical evidence, and as you know, some Some payers will require us to get a very specific code for our first-team products. We are excited to have those conversations, but if you think about the time that it took to get expanded carrier screening, we're not necessarily going to rely on anything happening quickly within the reimbursement market. But for sure, anytime innovation comes out, if we can get it quickly adopted into guidelines, we'll be sure to be talking to payers about trying to get increased reimbursement because you are right. It is a win-win for both patients as well as those that are reimbursing it.

And one moment for our next question. Our next question will be coming from Dan Brennan of TD Cohen. Your line is open, Dan.

Hey, good afternoon, guys. This is Kyle for Dan. Thanks for taking the questions. Wanted to shift over to the hereditary cancer side of the business. You know, volume grew 11% year over year off a pretty strong number, you know, Q3 last year. Just digging in a little bit, was any of the 3Q volume growth sort of any catch-up from the EMR issues you experienced the last few quarters? And then maybe on that, I know some peers have really put up some pretty strong numbers in the hereditary cancer testing side. Is there anything going on in the market that's really accelerated, you know, over the last, you know, 11 months?

Thank you for the question, Kyle. Yeah, and we are pleased with the performance we had for our overall hereditary cancer portfolio, particularly for MyRisk, which will play an even bigger role going forward, as you heard us talk about with the launch of the updated, expanded panel that we have later this month. I think you also asked, like, is there anything specific going on? Is there a catch-up? I don't think so. You know, the testing that has to happen as it relates to the oncology patient that happens in a very timely manner, we've continued to be strong there. What we have done, as you heard Mark talk about in his section, is we have continued to make improvements to the workflow for the actual customers. Some of the challenges that were, you know, that we weren't as easy to work with, we've improved on. We've had some improvements on EMRs, you know, the EMR part of the ordering and reporting journey. So those things, I think, are starting to show fruit, along with what Brian and his team have been doing, have really been starting to drive. And I think we're still early days. of our programs like the Breast Cancer Risk Assessment Program and other things to really help those in the unaffected providers and healthcare systems better identify and bring patients forward. And I think that there's a lot more to come there. And the overall market, again, as a reminder, that market is closer to $5 billion, less than 50% penetrated, and it's a great market development opportunity for us and perhaps other competitors in this space. i don't know mark if you or brian have anything to add about anything in the market but what it does reaffirm for us our results and maybe the broader dynamics is a great foundation for myriad you know with our gold standard test to continue really growing profitably in 26 and beyond got it and then maybe on the partnership side you know you announced

the Pathomic Partnership earlier this year. You just announced the Sophia Partnership. Where in the portfolio, you know, might you be looking to add more of these partnerships in the near term?

Yeah, great question. You know, our primary focus is first and foremost related to the cancer care continuum. And we are excited, by the way, by both of those partnerships. And for the Prolaris partnership with Pathomic, as I said, and now that Brian's here, we're also, him and his team, are working in partnership with Mark and others to think about excellence in commercial launch. And that's why we're thinking about exactly how to sequence that into the first half of the year. In terms of next, where to look, What I would tell you is we are particularly interested in partnerships that allow us to expand into these high-growth, attractive market segments of the cancer care continuum. Sophia is a great example of that. We knew that we needed an offering starting with for pharma partners in liquid biopsy for therapy selection using a comprehensive genomic panel. We're starting by leveraging the work that both Sophia has done in partnership with MSK MSK access, is there liquid biopsy assays? We're excited to start there with the option to provide that liquid biopsy assay down the line for clinical use, for clinical testing. And if you think about the other exciting areas, important high growth areas, that includes other elements of therapy selection. It includes areas such as IO therapy response monitoring, you know, other things we might be able to do to, you know, go even faster in MRD. And I'm not saying we're going to do all these, but these are illustrations, some of the things that we're deeply thinking about that we think would add value to the customers we serve with a more comprehensive portfolio, but help us also in a possible way to accelerate growth.

Got it. Thank you.

And our next question will be coming from Lauren Timmons of Jefferies. Your line is open, Lauren.

Hey, team. This is Lauren on for Tyco. Just to kind of level set the volume growth and top line performance for HCT in particular, revenue was down still 4% year over year, even though you had 11% volume growth. So maybe just kind of what were some of the biggest mix in ASP effects and how that's going to evolve, especially with the cancer tests targeted November 2025 launch. And then the second kind of follow-up question there in terms of the cancer care continuum, what are some of the specific, I guess, KPIs, whether that's integration pathways with oncology networks, EMR-triggered orders that you're going to be looking for for targets for 2026? Thanks.

Thank you, Lauren. Appreciate the questions. Why don't we start with you, Ben, to help with the first part, and then you can start with the second question, Mark. You can help with that one, too.

Thanks. Sure. Yeah, thanks for the question. So, you know, we touched on the primary drivers that resulted in 4% decrease in revenue year over year. You know, ASP was the driver of that, and the biggest pieces of that change year over year, naturally, we're still feeling the impacts of the medical policy change from UnitedHealthcare as it relates to GeneSight. Sam also referenced the $1 million impact for the divestiture of our EndoPredict business. So the combination of those two things We're an $8 million headwind in the quarter year over year, and that resulted in flat revenue when we compare this year's Q3 relative to last year's Q3. And then Sam also referenced the change in estimate to revenue that benefited last year's Q3 of nearly $9 million that did not recur this year. So the combination of those two headwinds, when you adjust for those, we're looking at about 5% revenue growth year over year. And then in my prepared remarks, I talked about a couple of additional items that impacted ASP during the quarter. So as it relates to the enterprise, we had product mix that impacted our ASP. And then when we think about hereditary cancer specifically, we had some payer mix that impacted ASP. So, you know, we've been really pleased with the progress that we have made with our biopharma business. Really strong ASPs in connection with that revenue, but that revenue is also lumpy. Because it is lumpy, we had some adverse effect to our hereditary cancer ASP as a result of the lumpiness of that biopharma hereditary cancer revenue in the quarter. And then we also had some impact ASP for hereditary cancers that relate to some out-of-period revenue. Although it was not material to the organization during the quarter, it did have a little bit of an impact on ASP for hereditary cancer. Great. Thank you, Ben. Mark, do you want to take a little bit of the same question?

Yeah, Lauren, related to the KPIs, and we'll provide more of this as we get into 2026, probably at JPMorgan and sort of beyond. But I think in addition to the standard KPIs, when you think about volume as well as revenue, I think if we think about the cancer care continuum, we'll be looking a little bit more into the providers that are actually ordering our tests and thinking about how are we expanding that provider base. as well as providers that are using multiple of our products. So we have several of our top customers today that we've heard from who want to just use a single lab like Myriad. And so I think our ability to be able to sell into that channel for both hereditary cancer, HRD, MRD, and our full continual will be something that we'll be sharing in the future. But that's just a glimpse, but we'll share more at J.P. Morgan.

That's great. Thanks so much.

And our next question will be coming from Subbu Nambi of Guggenheim. Your line is open.

Hi, this is Rikki on for Subbu. Thanks for taking our question. Wanted to ask another on women's health. I know a lot's already been asked, You're quite differentiated in offering pre-pull at eight weeks. That's a week earlier than the blood draw for most of your competitors. And that timeline advantage though is only really clinically meaningful if the patient and the physician are receiving their results sooner than the competing tests that are offered for a nine-week blood draw. So if your results take a two-week turnaround, then the competitor takes a week after drawing the sample at nine weeks, both of you are delivering results in the 10th week of gestation. With that context, what is your current average turnaround time for your prequel results today?

Yeah, I mean, I'll let Mark take this in more detail, but I believe our turnaround times for, you know, almost all of our products are industry standard or industry best. So there's not like an extended period. Mark, do you know offhand?

Yeah, let me add to that because, and I don't disagree with what you articulated other than I think the turnaround time of when of when they get the result isn't as important as when the patient is showing up. So for our providers who like to see the patient at that eight-week timeframe, when the provider is showing up, they're able to use our test at that time. So it's more about patient convenience and it's more about workflow as opposed to when they're getting the result on the back end. That said, as Sam mentioned, we have very, very competitive turnaround times. So often they will be getting the answers maybe one week sooner. But again, it's probably less about getting the result one week sooner as opposed to meeting the patient when they're coming into that OBGYN office at that eight-week time period. And again, maybe that's not important to all of the providers, but to those that really care about it, that's where Myriad shows up best.

I see that's really helpful context. Thank you. And then maybe just as a follow up for first gene, do you expect to have a similar turnaround time given that it's more of a combined assay and then first gene is launching with the nine week blood draw? I'm just curious if you're working in R&D on moving that up to eight weeks as well. Thank you.

Mark, you want to take this one? Yeah, so we do expect to, when we launch fully commercially, to move it to eight weeks as well, to answer that question. And we also expect that very similar turnaround times as well. So yeah, I would not expect any major delays related to the first gene test.

And just to add, Mark, You had said your prepared marks. We've been pleased so far with the sample we've been running. The efficiency, the yield internally, you know, all of that has been working really well. So there's no reason to believe as we ramp into full commercial launch that we shouldn't continue to have really, really tight turnaround times.

Great. Thanks.

And our next question will be coming from Lou Lee of UBS. Your line is open.

Great. Thank you for taking my questions. I think the first one on Gene's side, you're expecting the voting to be mid-single digit to high single digit. And then you also highlight some of the reimbursement from like California Medicaid. So how should we think about the ASP assumption for 2026?

Yeah, I'll start then. Mark and Ben, I'll look at both of you to answer it. So Lou, first I will say, very pleased with the team, both our commercial team as well as our pair team, if you want to rev cycle and pair market teams, both for being able to really be targeted and engaging customers. And as you saw in Mark's slide, we had a record number of new prescribing physicians that also ordered GeneSight within the quarter. You know, the results, remember, we're saying we should be going at about the mid-single digit. We performed a little bit better than that this quarter. We're pleased by that. And, you know, I think in one of your prepared remarks, you also talked about the number of pairs we've continued to add on for GeneSight, nine new states beginning of the year, right, related to biomarker loss. But as it relates to AST and what to expect next year, I know you guys know we're not providing guidance for 2026. Is there any color that either of you would want to offer?

Yeah, sure. I'll just maybe repeat that both Mark and I touched on the fact that we've been really pleased to see health plans implementing medical policies in compliance with the biomarker laws, and none of those medical policies have a significant impact in isolation, but we continue to work towards having uh winds everywhere that we can get those and we'll continue to do that going forward and so you know our expectation is that we will continue to to have support with asp for gene site and and like sam said we'll talk more about 2026 and at a future date

got it um and then second questions um so I think we touch on some of the organizational structure change and you also mentioned there's and then you're going to ship some of the resources to create funding your key programs but um I guess I wanted to get a bigger picture are you expecting any um kind of like lower OPEX like any sizing of that like any other Areas that you expect to have more lower OPEX in addition to reallocation of the R&D, if that makes sense.

Yeah, no, let me start and then you can add here too. You know, listen, again, this is a very deliberate set of actions we've taken all with the intention of being able to serve our customers better, show up, cover more accounts. and improve the overall customer experience and win more. And specifically, some of the things I can tell you maybe answers your question is we will be adding a very meaningful number of additional sales-related positions. That's part of where the savings, if you will, related to our other actions are going to be applied. as well as the other programs really related to activating the new product launches that are coming up, right? Be it the Pathomic Prolaris launch that we have, the, of course, MRD being the most important one. And on MRD, it's both the programs on the marketing, you know, activation side, but it's also, you know, further on R&D for MR, the R&D that we're going to be adding. So, That's a high-level answer. I don't know if, Ben, if there's anything you'd add to that.

Maybe the only thing I'll add is we'll focus on investment to support our account executives with tools to enable them to be effective in the work that they do.

Okay. And our next question comes from Mason Carrico of Stevens. Your line is open.

Hey, guys. Good afternoon, and thanks for taking the questions. This is Ben for Mason. Just on the pathomic prolares combination test. Could you give us some insight into the cadence of clinical data releases on this assay? What should we expect to see called over the next 12 months?

Well, thank you for the question, Ben. We are going to be launching the test, our first combined test in the first half. And again, this will combine our leading molecular tests with the AI capabilities, looking at morphology and stand slides and really being able to draw conclusions in that and the combination of which we believe will drive an increased level of clarity and to help physicians on what they do in treatment. So this is our first test and it's at the time of biopsy. What we have planned then for some time in 2027 is the next follow-on offering, if you will, which will allow us also to start addressing parts of the overall prostate cancer segment, which includes what happens post-radiation or post-radical prostatectomy. So that's a future product to come, but right now our focus and what we've seen a lot of interest from customers in anticipation is for our first combined product launch in the first half.

Great, thank you for that. And you've highlighted the progress you've made reducing no pay rates and tightening your RCM initiatives. Would you be able to quantify how much of the 2025 ASP benefit has come from some of these operational factors versus really the new coverage wins and how much runway remains on the operational side?

Ben? Sure. Yeah. So, um, you know, we've talked about the fact that about 1% decrease in no pay rate is worth about $8 million or so in revenue. Now it's, it's important to remember that with the change in United healthcare medical policy, it really muddies the water in changes in no pay rate year over year. Um, we, we had talked about being at about 42% in 2024. And from a comparison standpoint, it's an apples to oranges. And so we're not in a position to quantify the benefit of the impact that we have had this year. But I'll say that we continue to focus on improving no pay rates and optimizing revenue cycle management. And then just maybe one more thing for context is we think about where no pay rates can go. If you think about across the portfolio, our most mature products in the hereditary cancer space, we're still looking at about a 30% no pay rate. And so we'll continue to focus on reducing and improving no pays, but that just gives you an idea that the best case scenario from a no pay rate standpoint, you're still looking at 30% plus with a really, really mature product portfolio.

And then I would just add a summary of that is we think that there are many years of opportunity and goodness from continuing to improving or focusing on rev cycle improvements for the ASP. Great.

Thanks for taking the questions.

And our next question will be coming from John Wilkin of Craig Halem. Your line is open.

Yeah, I guess. So it looks like your my risk volume in the unaffected segment picked up pretty meaningfully versus the last two quarters this quarter. And I know you guys had talked about some headwinds that you'd seen in Q4 and going into Q1 just with delays and EMR integrations and such. But can you just parse out what you're seeing now that's driving that acceleration and how you see that continuing into the future? And also, if you think the expanded my risk panel is going to drive any incremental acceleration on top of that.

Yeah, thank you for the question. And I think as I might have mentioned, you know, we are pleased for the continued improvement and the performance of the unaffected part of the market with MyRisk. And yes, it is the results and the meaningful impact or the pickup in the volume growth is a combination of really working on the pain points or the areas we can improve on the customer workflow, includes the work that's being done by our teams related to EMR abilities. Also just thinking, working with the customers on what does it really take from day one? It's not just about turning on the EMR, but what is the real experience like? What's happening in the office when orders are being placed? What are the questions that they have? So all of those things through customer success managers and other positions we've instituted I think are starting to make a difference. I think, again, also we've done certain things related to our programs. We've learned ourselves as we're implementing these breast cancer risk assessment programs to continue to iterate and make those even more fine-tuned to drive value for our customers who are, again, trying to identify and be able to identify and then engage with with patients for testing. So all of those activities, I think, have started to show some real promise and real impact already. There's no reason, by the way, to think that that's not going to continue staying strong and get stronger as we implement more programs. And yes, we absolutely believe now having a updated, expanded MyRisk panel, which, again, will launch this month, will only help support the growth, you know, at where we've been or even further. And Mark, I think you had your prepared comments. This will be, this panel will be the only one related to, can you just state those words, the NCCN?

Yeah, it's the only panel. When you look at the NCCN guidelines as well as the ASCO guidelines, they actually parse out sort of different levels. And so for NCCN, it'll be the only panel that includes all the high-risk genes that they recommend as well as on the ASCO side, the ones that are strongly recommended.

So the takeaway is we believe that this will be a very important catalyst for growth going into 26.

Got it. Thanks. That's helpful. And then just on GeneSight, it sounds like you alluded to that your investments in that business going forward are kind of assuming that there is no change in UnitedHealth coverage, which seems prudent. But does that imply that that business is going to be maybe less of a priority within the commercial organization? And just how do you balance that with the fact that, I mean, it seems like that business has seen a

excluding the united health impact a lot of momentum this year with with added payer coverage decisions and more um more clinician adoption yeah listen i mean we we are pleased with the performance of gene site and we really appreciate the the hard work and efforts in a very focused way that our teams have been taking again both on the commercial side uh as well as on you know on the pure market side and so forth so We think it continues to be an important part of our portfolio. But what we have said very explicitly is in this new phase of Myriad, this new time of Myriad, we are incredibly deliberate, focused, and disciplined on what we prioritize, particularly related to development and other growth. And that's really the point on GeneSight.

Perfect. Thank you, guys.

Okay. And I would now like to turn the call back to Matt for closing remarks.

Thanks, LaTanya. This concludes our earnings call. A replay will be available via webcast on our website for one week. Thank you again for joining us this afternoon, and have a good night.

And this concludes today's program. Thank you for participating. You may now disconnect.