Myriad Genetics Inc Q3 FY2025 Earnings Call

Good day, and thank you for standing by. Welcome to the Myriad Genetics' Third Quarter 2025 Earnings Conference Call. 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 Scalo. Please go ahead.

Good afternoon, and welcome to the Myriad 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 8-K and can be found on our website at investor.myriad.com. I'm Matt Scalo, 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 Investors 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 in 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 in 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 in 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. GeneSight 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 the second quarter, as we continue to increase the volume of testing customers affected by Q2 challenges and add new customers. Turning now to profitability. We generated strong adjusted gross margin of 70.1% in the third quarter and closely manage our discretionary spend as reflected in our adjusted operating expenses line. 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 to 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 5 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 Welebob for Biopharma and CDx Services, Hosein Kouros-Mehr for Oncology R&D, Vishal Sikri for Product, and Brian Donnelly 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 ultrasensitive tumor-informed Precise MRD test and are on track to start offering the test for clinical use in the first half of 2026. First indication will be Stage II, Stage III 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 Prolaris prostate cancer test that combines the power of molecular and AI, based on our partnership with PATHOMIQ 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 FirstGene 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 GeneSight test by concentrating high-value accounts, leveraging state biomarker laws, and building on the success we've seen over the past few 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 MyRisk 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. Prolaris 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 Prolaris 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 ultrasensitive Precise MRD test showed clinical value in patients with oligometastatic clear cell renal cell carcinoma, which is a very low-shedding tumor and requires an MRD test in the ultrasensitive 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 overall survival rates of 94% at 2 years and 87% at 3 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 on 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 MyRisk, with our current momentum in hereditary cancer testing, now is a perfect time to launch Myriad's expanded MyRisk with RiskScore 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 the $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 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 the 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 myGeneHistory 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 MyRisk 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, FirstGene, and expect the 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 GeneSight 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 9 states for GeneSight year-to-date related to biomarker laws. Most recently, the California Medicaid program, Medi-Cal, added GeneSight 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 reacceleration in both unaffected hereditary cancer volumes and GeneSight 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 the 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 GeneSight 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 GeneSight 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 GeneSight 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 in 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 $1 million 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 Myriad'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 multiyear 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 million to $828 million, a gross margin range of between 69.5% and 70%, and adjusted operating expenses range of between $562 million and $568 million as well as adjusted EBITDA and adjusted EPS guidance ranges of between $27 million and $33 million and a loss of $0.02 and a gain of $0.02 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 want to take a moment to reiterate Myriad's long-standing commitment to supporting patients and health care 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 RiskScore 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 operational 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 an 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 used 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.

Operator, we're now ready for the Q&A portion of the call.

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 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.

Yes, 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 that 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 and be able to increase our win rate. This includes, in some instances where we've taken out multiple layers of management. We've made other choices on positions that we've deemed to be less critical than others that are related to having more feet on the street, if you will, to compete, 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?

Yes. I would just say that the actions and the focus are 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.

I have a question regarding the NIPT side. It seems like your performance was softer than expected and below consensus, so I'm curious if you are noticing any shifts in market share. I know you mentioned sequential growth, but with new competitors entering the space and others aggressively promoting mother-only blood draws, could you clarify what you are observing in the market compared to Myriad's position, and whether you are experiencing any loss of market share?

Thank you for the question, Puneet. We did face some operational challenges in Q2, which we have fully resolved. We had anticipated that it would take several quarters to return to our expected growth levels, aiming for at least single-digit volume growth or higher. We’ve had positive traction from new products like Prequel at 8-week gestational age and Foresight with expanded carrier screening, along with the recent addition of F8 and FXN. Last quarter, we experienced a 7 percent decline in volume, but we discussed that volume is now flat. While we're not satisfied with flat performance, we're on track with our expected pace. There are certainly new entrants in the market, but we are excited about the potential to boost our growth with FirstGene, which combines NIPS screening and carrier screening.

I'd like to follow up on Puneet's question regarding the NIPT business. Can you provide some insight into the issues with the new ordering management system, why these problems are extending into this quarter, and why they may not resolve by the second quarter? Also, regarding the market dynamics he mentioned, could you explain how single-gene NIPT might contribute to your growth next year? Are you anticipating any changes in data, especially after the CONNECTOR study is completed? Additionally, could you discuss some long-term differences you might see compared to your competitors? I have a quick follow-up on NIPT as well.

Thank you, Dave, for your question. I'll begin and then invite Mark to join me in addressing it. We wish we could quickly regain all the customers and volume we've lost. As mentioned before, many of our high-volume customers use us alongside a few other providers for these prenatal tests. We've faced challenges, which have now been fully resolved, that led to some volume shifts away from us. We are in the process of improving this situation, as reflected in our turnaround from a 7% volume decline to flat volume. While this is not our ideal state, we are on track to demonstrate volume growth in the upcoming quarters. Regaining customers and attracting new ones takes time, and we have been making progress on that front. The second part of your question refers to FirstGene, our screening that integrates NIPS with expanded carrier screening. We're excited about this, Mark, perhaps you can elaborate on our observations so far and how we believe it will help us broaden our market reach.

Yes, sure. Thanks, Sam. Look, I think we knew when we started developing FirstGene 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 and 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 that will 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 a part of that. Yes, we believe this will help expand the market, the market opportunity for us and 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 want to ask one more question about the revenue growth potential from an ASP perspective in the coming years. Can you remind us if you're getting paid for RHD? When do you think that will happen? Any updates on ACOG, microdeletions or expanded carrier screening? Lastly, regarding the single-gene NIPT offering, I understand that you will no longer require a father sample. Is there a possibility of going back to reimbursement in the future for that, considering you are saving the system money by not testing the father?

Yes. Thank you, Dave. I think you had quite a number of important questions built into. 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 FirstGene offering. In terms of ACOG, we remain intrigued and interested and fully ready to catch the wave when ACOG guidelines are introduced. An 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 father reimbursement related?

Yes. I believe that as we gather more clinical evidence and considering that some payers will want us to obtain a specific code for our FirstGene products, we are eager to engage in those discussions. However, reflecting on the time it took to achieve expanded carrier screening, we shouldn't expect rapid changes in the reimbursement market. Nevertheless, whenever we introduce innovation, if we can quickly get it incorporated into guidelines, we will certainly be in discussions with payers to seek increased reimbursement. It's beneficial for both patients and those providing reimbursement.

This is Kyle on for Dan. I wanted to shift over to the hereditary cancer side of the business. Volume grew 11% year-over-year off a pretty strong number Q3 last year. Just digging in a little bit, with any of the 3Q volume growth, sort of, any catch-up from the EMR issues you experienced in 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 over the last 11 months?

Thank you for the question, Kyle. Yes, 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 if there is anything specific going on, is there a catch-up? I don't think so. The testing that has to happen as it relates to the oncology patient 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 we weren't as easy to work with, we've improved on. We've had some improvements on the EMRs, the EMR part of the ordering and reporting journey. So those things, I think, have started to show fruit along with what Brian and his team have been doing to really help those in the unaffected providers and health care systems better identify and bring patients forward. And I think 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 the space. So 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 with our gold standard tests to continue really growing profitably in '26 and beyond. Yes, great question. Our primary focus is related to the cancer care continuum, and we are excited about both of those partnerships. For the Prolaris partnership with PATHOMIQ, now that Brian is here, he and his team are collaborating with Mark and others to ensure excellence in the commercial launch, which is why we are planning to implement that in the first half of the year. Looking ahead, we are particularly interested in partnerships that enable us to expand into the high-growth market segments of the cancer care continuum. SOPHiA is a great example; we recognized the need for an offering for pharma partners in liquid biopsy for therapy selection using a comprehensive genomic panel. We are starting by leveraging the work that SOPHiA has done with MSK. MSK-ACCESS is their liquid biopsy assay, and we are excited to initiate from there with the option to offer that liquid biopsy assay for clinical testing in the future.

And our next question will be coming from Lauren Timmins of Jefferies.

This is Lauren on for Tycho. Just to kind of level set the volume growth and top line performance for HTT, 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 and ASP effects and how that is going to evolve, especially with the cancer tests targeted for a 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?

Sure. Yes. Thanks for the question. So we touched on the primary drivers that resulted in a 4% decrease in revenue year-over-year. ASP was the driver of that. 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 were 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 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. And 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 to ASP for hereditary cancer as it relates 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.

Mark, do you want to take a little bit of the first question?

Yes, Lauren, related to the KPIs, and we'll provide more of this as we get into 2026, probably at JPMorgan sort of beyond. But I think in addition to the standard KPIs, when you think of volume as well as revenue, I think as we think about the cancer care continuum, we'll be looking a little bit more into the providers that are actually ordering our test and thinking about how we are 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 continuum will be something that we'll be sharing in the future, but that's just a glimpse, but we'll share more at JPMorgan.

This is Ricki on for Subu. I wanted to ask another on women's health. I know a lot has already been asked, but you're quite differentiated in offering Prequel at 8 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 9-week blood draw. So if your results take a 2-week turnaround, then the competitor takes a week after drawing the sample at 9 weeks, both of you are delivering results in the 10th week of gestation. So with that context, what is your current average turnaround time for your Prequel results today?

Yes. I mean, I'll let Mark take this in more detail, but I believe our turnaround times for almost all of our products are industry standard or industry best. So there's not like an extended period. Mark, you know offhand. Yes, let me add to that because I don't disagree with what you said, but I think the timing of when they receive the results isn't as crucial as when the patient is present. For our providers who prefer to see the patient around the 8-week mark, they can utilize our test during that visit. Therefore, it's more about patient convenience and workflow, rather than when they receive the results afterward. That being said, as Sam mentioned, we do have very competitive turnaround times, often providing answers a week sooner. However, it's less about receiving the results a week early and more about interacting with the patient when they come into the OB/GYN office at that 8-week timeframe. While this may not matter to all providers, it is significant to those who prioritize it, and that is where Myriad excels.

Mark, do you want to take this one?

Yes. So we do expect to, when we launch fully commercially to move it to 8 weeks as well to answer that question. And we also expect a very similar turnaround time as well. So yes, I would not expect any major delays related to the FirstGene test.

And just to add, Mark, you had said in your prepared remarks, we've been pleased so far with the samples we've been running, the efficiency, the yield internally, 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.

And our next question will be coming from Lu Li of UBS.

Great. I think the first one on GeneSight. You're expecting the volume to be mid-single digits to high single digits. And then you also highlight some of the reimbursement win from like California Medicaid. So how should we think about the ASP assumption for 2026?

Yes. I'll begin, and then I'll turn it over to Mark and Ben for their insights. First, I want to express my satisfaction with our teams, especially our commercial and payer market teams, for their focus and engagement with customers. As Mark mentioned in his presentation, we achieved a record number of new prescribing physicians ordering GeneSight in this quarter. We anticipated mid-single-digit growth, and we actually performed slightly better than that this quarter, which we're happy about. In your earlier comments, you also mentioned the number of payers we've added for GeneSight, including nine new states at the beginning of the year related to biomarker laws. However, regarding the average selling price and expectations for next year, as you know, we are not providing guidance for 2026. Is there any additional information that either of you would like to share?

Yes, 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 wins everywhere that we can get those, and we'll continue to do that going forward. And so our expectation is that we will continue to have support with ASP for GeneSight. And like Sam said, we'll talk more about 2026 at a future date.

Got it. For my second question, I think you mentioned some changes in the organizational structure and that you're planning to shift some resources to support your key programs. I would like to understand the bigger picture. Are you anticipating any reduction in operating expenses? Could you provide any insights into other areas where you expect lower operating expenses in addition to the reallocation of R&D?

Yes. No, let me start, and then you can add here, too. 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 other programs really related to activating the new product launches that are coming up, right, be it the PATHOMIQ, 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 activation side, but it's also further on R&D for MRD 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 would 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.

This is Ben on for Mason. Just on the PATHOMIQ, Prolaris combination test, could you give us some insight into the cadence of clinical data releases on this assay? What should we expect to see, call it, over the next 12 months?

Thank you for the question, Ben. We plan to launch our first combined test in the first half of 2026. This test will integrate our leading molecular test with AI capabilities, focusing on morphology and staining slides to draw conclusions. We believe this combination will enhance clarity and assist physicians in their treatment decisions. This initial test will be at the time of biopsy. In 2027, we intend to offer a follow-on product that will address aspects of the prostate cancer segment, including conditions following radiation or radical prostatectomy. For now, we are concentrating on the significant interest from customers for our first combined product launch in the first half of 2026.

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. Yes. So we've talked about the fact that about a 1% decrease in no-pay rate is worth about $8 million or so in revenue. Now it's important to remember that with the change in UnitedHealthcare medical policy, it really muddies the water in changes in no-pay rate year-over-year. 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, as 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 to that as we think that there are many years of opportunity and goodness from continued improvement or focusing on revenue cycle improvements to the ASP.

So it looks like your MyRisk volume in the unaffected segment ticked up pretty meaningfully versus the last two quarters this quarter. And I know you guys have talked about some headwinds that you had seen in Q4 and going into Q1 just with delays in EMR integrations and such. But could 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 MyRisk panel is going to drive any incremental acceleration on top of that?

Thank you for the question. We are pleased with the ongoing improvement in performance within the unaffected segment of the market with MyRisk. The positive results and significant increase in volume growth stem from addressing customer workflow pain points. This includes the efforts of our teams related to EMR capabilities and working closely with customers to understand what is required from day one. It's not solely about activating the EMR; it's about understanding the actual experience and the dynamics in the office when orders are placed, including the questions customers have. Our customer success managers and other roles we've introduced are starting to make a difference. Additionally, we've made progress with our breast cancer risk assessment programs, allowing us to refine them further to deliver greater value to our customers. We're focused on identifying and engaging patients for testing, and these initiatives have begun to demonstrate real promise and impact. We believe that this positive momentum will continue and strengthen as we launch more programs. Furthermore, we are confident that the updated and expanded MyRisk panel, set to launch this month, will enhance our growth trajectory. Mark, in your prepared comments, you noted that this panel will be related to the NCCN.

Yes. 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 will 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.

Great. That concludes the Q&A portion of the call. Thank you all for your questions. I would now like to turn the call back to Sam for any closing remarks.

Thank you to everyone for joining our call today. I look forward to discussing our progress with you in the future.

Thanks for your time today. A replay of this conference call will be available on our website in the Investor Relations section.

Thank you for participating. This concludes today's call. You may now disconnect.