Myriad Genetics, Inc.

Good day and thank you for standing by. Welcome to the Marriott Genetics Second Quarter 2025 Financial 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 your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Matt Scallo, please go ahead.

Good afternoon, and welcome to the Mary Genetics second 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 Scalo, Senior Vice President of Investor Relations, and on the call with me today are Sam Raha, our President and Chief Executive Officer, Scott Loeffler, 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 SEC, 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. With that, I'll now turn the call over to Sam. Thanks, Matt.

Good afternoon, everyone, and thank you for joining us. Before I begin, I want to share that I believe today, as I did when I joined the company, that Myriad is really good at a lot of things and we have significant potential, but we have not lived up to our potential yet. I'm excited about the journey we're on to live up to that potential by focusing on high growth market segments and executing with stepped up urgency and strengthened execution rigor. Let me start with our results. I'm pleased to report on the overall progress the team has made, both financially and operationally, in the second quarter. We generated revenue of $213 million, representing an increase of 5% year over year, when you exclude UnitedHealthcare's decision on GeneSight and the divested European EndoPredict business. Growth in average revenue per test during the second quarter, up 2% year over year, with growth across most of our tests year over year, as a leading contributor to our strong Q2 results. This growth in underlying average revenue per test has been enabled by great execution in Q2 and over many quarters on multiple programs that are part of our pricing improvement operational plan by our strong revenue cycle team. There are no material revenue contributions from prior periods. This momentum certainly provides a nice tailwind in the second half of the year and supports our profitable growth journey. Our strong results were also enabled by the actions we have been taking to address the challenges we noted on our Q1 call. I'm pleased that our execution has been better and quicker, contributing to our better-than-projected revenue growth, a step forward on delivering on myriad's potential. Now, I want to talk about testing volume. We continue to have strong volume growth for MyRisk HCT and oncology at 14% over the year-ago quarter. we saw a return to volume growth for MyRisk HCT for unaffected, as our efforts on addressing previously identified challenges with customer workflows, including EMR functionality, are starting to be addressed, which Mark will talk about further in his section. Gene site volume increased from low single digits to 5% growth year over year, as we had anticipated, based on our organization settling in after deliberate cost savings related actions we made in Q1 and our focus on targeted accounts. Polaris volume, as we anticipated, was slightly down year over year against a strong Q2 of 2024 compare, but up 6% sequentially over Q1 of 2025. Volume for our legacy prenatal products, Prequel and Foresight, declined 7% year on year. This was based on challenges we had with implementing an order management system which slowed down orders in Q2. I've been close to this. working with our CTO, Kevin Haas, Mark Verratti, and our Chief Commercial Officer, Brian Donley. We have fixed the prenatal ordering system issue. There's no remaining impact to customers, and we expect to see improving trends in prenatal volume growth starting in Q3. Along with maintaining strong growth for registry cancer testing and oncology, mid-single-digit growth for gene site, and resuming growth for our prenatal products, we are actively executing programs to increase growth for HCT and unaffected and Polaris. We believe these actions will lead to increasing volume growth in Q3 and Q4 and enable us to enter 2026 with momentum. Turning now to profitability. We generated strong adjusted gross margins, 71.5% in the second quarter, or 140 basis points greater than last year, and closely managed our discretionary spend as reflected in our adjusted OpEx line. Ultimately reported strong adjusted EBITDA $14.5 million, or 24% growth over last year, and $0.05 of adjusted EPS for the second quarter. I'm pleased that Marriott secured a $200 million term loan from Orbamed, a well-known investor in the healthcare industry. We ran a thorough process working with AgriCorp, and we're very happy with the number and quality of interested lenders. We're excited to partner with Orbamed on the credit facility which provides us with liquidity and flexibility to support our growth journey. The journey ahead will be enabled by our updated strategy intended to drive accelerated growth and profitability by focusing on the cancer care continuum, as we will refer to it as the CCC. Before I share more about our strategy, let me note that based on our Q2 results and the progress we're making on addressing identified challenge, We are raising guidance for 2025. Scott will share more details in his section. Now, on the next slide, I want to provide a summary of our updated strategy. Since becoming CEO, one of my top priorities has been to work on updating our long-range strategy to provide clarity on our direction for this next chapter of Myriad. Since May, we've made significant progress on advancing our strategy work. While next-level details will be completed over the coming months, The core of our updated strategy is to drive accelerated growth and profitability by focusing on the cancer care continuum. There are three strategic pillars to support its achievement. On the next slide, let me start by answering the question, why focus on cancer? After careful consideration of different possibility, we're choosing to focus on the cancer care continuum for a number of reasons. The cancer-related market is sizable and growing with good reimbursement. We are a pioneer in cancer diagnostics and have a strong reputation for high quality products established over 30 years. We have market leading products for HCT and HRD, and we have extensive commercial coverage with healthcare providers and systems. Now, let me walk you through our first pillar, focusing on the cancer care continuum to accelerate growth. We will leverage our leadership in hereditary cancer testing and increased growth with initiatives such as the Breast Cancer Risk Assessment Program, the upcoming launch of the expanded MI-RIS panel. We plan to expand our testing portfolio in other attractive cancer segments, such as therapy selection, including comprehensive genomic profiling and HRD assays, immuno-oncology therapy response monitoring, and MRD. As you can see here, these are large, high-growth market segments. And though there are other companies in these areas we believe we have the opportunity to build meaningful revenue streams here based on healthcare providers and systems wanting to work with only a handful specialty diagnostic labs that they trust who can provide multiple tests that they need. And we will leverage the established trust and reach that we have with thousands of relevant healthcare providers. Strategic partnerships, such as the one we have with Pathomic, to enable us to provide prostate cancer tests that combine the power of molecular and AI analysis will help us bring compelling tests to market faster. I expect to have more exciting news regarding strategic partnerships to share with you over the coming quarters. Also, as part of this pillar, we will plan to increase our investment in R&D for the CCC and focus on enhancing our commercial capabilities and customer digital experience. On this next slide, let me move to the other two strategic pillars. While we are focusing on accelerating growth in the cancer care continuum going forward, 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 will do this in prenatal health by leveraging recently launched tests, including pre-poll NIPS that can be performed eight weeks into pregnancy, and an expanded foresight carrier screen panel, both of which have been well received in the market. In addition, we recently commenced early access for our first gene multiple prenatal screen that we believe has significant potential to expand the prenatal market over time and plan to do a full commercial launch in 2026. We expect to continue to grow revenue for our market leading mental health test gene site by focusing on high volume accounts and leveraging state biomarker laws. Building on the success we've been seeing this past quarter, including a number of pairs newly initiating coverage of the test. And while we achieve this growth for prenatal and mental health, while maintaining a disciplined level of resourcing and investment in these businesses, while prioritizing investment in the cancer care continuum strategic pillar. The third strategic pillar is about our focus and commitment to delivering sustained profitable growth. While we will provide further financial detail in the future, We believe execution of this updated strategy will enable us to grow revenue in the high single digit, the low double digit range, and increase profitability over the next five years by complementing the revenue growth drivers outlined in the first two strategic pillars with increasing focus on maintaining financial discipline, growing revenue faster than operating expenses, and strengthening our planning and execution capabilities. We expect to fund near and longer-term revenue growth in part by maintaining industry-leading gross margin profile, which is enabled by low cost per test, leveraging operational excellence, and stable pricing, leveraging strong revenue cycle capabilities. Moving now to the next slide. I've already shared when introducing the CCC strategic pillar why we're choosing to focus on cancer and our strength that we believe we can leverage to drive accelerated growth and increase access for patients. I want to take a moment to share what we're going to do differently from before to enable our intended success. First, it's about capital allocation. We're going to be disciplined in prioritizing investments, resources, and organizational focus on attractive cancer care continuum opportunity. Next, it's about compelling portfolio. We plan to expand beyond the established tests we have in HCP and HRD to complement them with relevant offerings for other important high-growth testing applications. Next, it's about strategic partnerships. Unlike before, we see an increasing opportunity to serve attractive market opportunities in a timely manner by complementing myriad differentiated capabilities by leveraging select partnerships. And finally, it's about execution. We've started to and will think and act with elevated urgency and strengthen execution through enhanced processes, continuing to add the right talent and elevated rigor and discipline. I'm confident that the implementation of our updated growth strategy, based on these three strategic pillars that I've shared with you, along with strengthening our organization and execution, will enable Myriad to drive sustained, profitable growth. Now, let me hand it over to our COO, Mark Ferrati. Mark.

Thanks, Sam. Turning to the second quarter. I would echo Sam's comments regarding the strong, broad-based trend in average revenue per test, which was driven by a combination of test mix, sales targeting, revenue cycle projects, and expanding payer coverage.

Looking at our businesses.

Hereditary cancer revenue grew 5% for the quarter, reflecting 10% volume growth year-over-year in our oncology channel. and a modest but improving 3% volume growth in the unaffected population. This improving volume growth trend in the unaffected market is particularly important as it reflects an improving EMR environment due to focused workflow improvements put in place in our first quarter. Consistent with what we said on our first quarter call, these improvements can take several quarters to produce results, so we are pleased with the Q2 progress and expect continued growth throughout the coming quarters. As we discussed in Q1, we are expanding our breast cancer risk assessment program, including a fully automated process that enables providers to rapidly identify patients who qualify for additional screening. We continue to see positive momentum in our initial sites and expect to make further investments in our commercial capabilities to accelerate this program through the second half and into 2026 to fuel growth in our MIRIS volume. Our prenatal performance was mixed in the quarter, as revenue grew 7% year over year, helped by expanded payer coverage for foresight expanded carrier screening, but volume growth declined due to temporary interruptions encountered in the transition of our internal prenatal order management system. We have fixed the issue in the second quarter and do not anticipate further disruptions from our system change. Moving to oncology. In the second quarter, total oncology revenue grew 4% over the second quarter of 24. driven by strong hereditary cancer testing. I would call out that our MIRIS test continues to gain share in the affected market. In the second quarter, its volume grew 14% year over year. Shifting to prostate cancer, Prolaris revenue in the second quarter grew 4% year over year, an improvement from the last few quarters. Overall demand remains relatively consistent with 2024 trends and does not appear to have been impacted by the Q4-24 update to NCCN guidelines. And now that we have announced our partnership with Pathomic, we are excited to incorporate their AI technology platform into our portfolio. With the target of a first quarter 26 launch, Myriad will be the only company that will offer AI, biomarker, germline, and tumor profile testing. Although our volume has been relatively consistent, we are not pleased with this business performance and feel Prolaris has strong clinical utility and provider support. As mentioned on previous calls, we are investing in the commercial channel and other programs to grow and regain share in this market. I'm also excited to call out, in collaboration with National Cancer Center Hospital East in Japan, new clinical data regarding the use of Myriad's ultra-sensitive precise MRD test was presented at this year's American Society of Clinical Oncology conference in May. This data showed that 100% baseline sensitivity and that 60% of patients testing positive one month after surgery had levels only detectable via our ultra sensitive MRD test. We are excited to commence an early access launch of our ultra sensitive precise MRD test in the first half of 2026. Moving to our women's health business. In the second quarter, women's health delivered revenue of 90 million, an increase of 4% over prior year period. As I mentioned earlier, we are pleased to see incremental positive momentum in hereditary cancer testing in the unaffected market, with revenue growth of 1% and volume growth of 3% year over year. We remain optimistic about our increasing tailwinds from EMR integration and breast cancer risk assessment program implementations In addition, we are seeing continued positive traction in hereditary cancer testing from our expanded commercial partnerships like J-Screen. As for prenatal testing in the second quarter, we encountered modest volume headwinds. As we discussed, we fixed the internal issue and anticipated prenatal test volume to accelerate in the second half of the year. As for our commercialized tests, pre-equal at eight weeks and foresight, we continue to see positive demand. And I would call out incremental positive payer coverage for the expanded carrier screening panel ahead of any ACOG guideline update. Lastly, the team is excited about the early access launch of our first gene multiple prenatal screening in June. We believe this test provides added insight to providers and has the potential to expand the overall addressable market. We are looking forward to full commercial launch next year. Turning now to mental health. In the second quarter, the team generated gene site revenues of $38 million on volume growth of 5% year-over-year, an improvement from our first quarter that was impacted by the realignment of group resources. We continue to drive expansion of the ordering provider base, achieving a record number of ordering clinicians over 36,000 in the second quarter. While quarterly revenue continues to be impacted by UnitedHealthcare's coverage policy change, We continue to make progress publishing additional data, such as the meta-analysis accepted for publication in the Journal of Clinical Psychopharmacology that follows the economic utility data published in the same journal in Q1. We expect United to review our new clinical data as part of their typical review cycle in the fall. 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 for gene site in Q1 and Q2 related to biomarker laws. Most recently, the California Medicaid program, Medi-Cal, added gene site with a September 25 effective date, noting we have not seen any new negative policies this year. I am proud of our gene site team that continues to drive growth and focus on the unmet need in mental health care treatment. Building on what Sam shared, Our strategy for gene site growth includes continuing our highly effective digital engagement from driving provider and patient awareness to provider onboarding. It also includes optimizing patient direct payment options and optimizing revenue cycle workflows to maximize reimbursement. I will now turn the call over to our CFO, Scott Loeffler.

Thanks, Mark.

I'll start with a recap of our Q2 consolidated financial results. For the second quarter, we reported revenue growth of 1% year-over-year, with test volume down 1%, but average revenue per test up 2%. The improvement in second quarter overall revenue per test reflects a combination of product mix and the expansion of payer coverage for a number of tests. There was no material contribution from prior periods in either the second quarter of 2025 or 2024. Therefore, we have a fairly clean view of underlying organic rate trends, which continue to be very encouraging. While Q2 rates were unfavorably impacted by the change in United Healthcare policy with respect to gene site coverage, we continue to see a positive trend in underlying rates across our portfolio. This is a continuation of the generally positive trend we have been reporting for at least a year now and represents another proof point for the great work being done by our revenue cycle and payer markets teams, along with others throughout the company. As we have said before, I want to emphasize the sustainable nature of these improvements, which we believe represent both the great work being done by our team, as well as a maturation in the reimbursement landscape for our products. As Mark pointed out, the hereditary cancer testing in the affected population saw the strongest revenue growth in the second quarter. with revenue increasing 9% year-over-year. Our pharmacogenomics business saw revenue decline 12% year-over-year due to the impact of the UnitedHealthcare coverage decision, but volume growth year-over-year rebounded in Q2 as the team adjusted to reallocated resources. You may recall that we attributed the underperformance in gene site volume growth in Q1 to the transition associated with our reorganization of the commercial organization in pharmacogenomics. We had predicted that once the newly organized team had more time to stabilize, we would see a recovery in volume growth trends. The recovery to mid-single digits volume growth for gene site in Q2 is a validation of that view. The combination of a reacceleration in gene site volumes and unaffected HCT volumes represents an important proof point in our efforts to recover from the headwinds we cited in Q1, buoyed by the incremental strength in reimbursements. Even with the modest overall Q2 revenue growth, we were able to expand our growth margins by 140 basis points to 71.5%. This year-over-year improvement reflects favorable test mix, expanding payer coverage and lab efficiencies, and is a testament to the power of our scalable business model. Second quarter adjusted operating expenses increased minimally year over year and reflect cost controls across SG&A. We continue to focus on striking the right balance between investment for future growth and profitability with a concerted effort to divert spend to areas consistent with our strategic priorities. While we are pleased with the favorable progress in our overall business results, we did have a significant non-cash negative item impacting our GAAP results. Due to the significant and prolonged decline in our market capitalization this year, we recognized impairment charges of $317 million of goodwill and intangibles in the second quarter. This charge is non-cash and excluded from non-GAAP EPS. It is important to emphasize that this charge does not represent a meaningful change in our business outlook. We are simply following standard accounting practice which required that we test the carrying value of our goodwill and intangibles in light of the drop in market cap. Without getting too deep into the mechanics of the process, our testing result was adversely impacted by factors such as much higher assumptions regarding cost of capital in connection with the drop in market cap. So I would characterize the charge as the result of developments that had already occurred earlier in the year, as opposed to any deterioration in expectations. Next, I'll speak to the trends supporting overall robustness in revenue per test. For a while now, we have provided details regarding a number of key drivers for sustainable progress in average revenue per test, including various investments and initiatives by both our revenue cycle and payer markets teams. We continue to see positive traction from these ongoing investments in revenue cycle workflows and from our ongoing payer engagement activities. These include, among other things, working with health plans to encourage their implementation of medical policies that conform to state biomarker legislation. As discussed on prior earnings calls, there is a growing list of states that have passed biomarker legislation that lends itself to ensuring access to precision medicine and advanced diagnostics. As we've mentioned, we recently received expanded commercial and managed Medicaid coverage for GeneSight, and as Mark called out, We are pleased to see California's Medicaid program, Medi-Cal, commencing coverage beginning in September. And there are several other payers who have moved forward with gene site coverage. Perhaps the most significant area of progress has been in prenatal testing, where we have seen a significant uptick in payers covering expanded carrier screening, even without an update to ACOG guidelines that has been anticipated for such a long time. We applaud the progressive approach that many payers are now taking to cover ECS testing, and we see this trend continuing to benefit prenatal reimbursement going forward. Year to date, our team has won 49 new product coverage or medical policy expansions from payers as we seek to bridge gaps in coverage across our no-pay universe. As I have said in the past, no one of these wins will generally meaningfully move the revenue needle. but we certainly expect the accumulation of many small and medium-sized wins over time to contribute to the maturing and more stable rate environment for our products. Next, we'll take a deeper look at the unusual items impacting our year-over-year revenue trajectory to provide a better sense for performance of the underlying business. While revenue in Q2 of this year compared to Q2 of 2024 grew 1%, you've also heard Sam reference a second quarter 2025 revenue growth rate of 5% after adjusting for the impact of certain items on our Q2 of 2024 baseline. Namely, UnitedHealthcare's net impact on GeneSight of $7.1 million and the divestiture of our EndoPredict European business of $2.4 million. With these adjustments, we are able to show what we consider to be a clearer view as to Myriad's underlying performance trends. Next, let's discuss the company's recent capital raise. Last week, we entered into a five-year term loan with Orbamed, a well-known healthcare investor. This agreement provides Myriad an initial tranche of $125 million immediately at a floating rate of one month SOFR plus 650 basis points. or an annual interest rate of approximately 11% at current rates. The agreement also has a two-year option to draw on an incremental $75 million of committed financing, reaching a potential total loan amount of $200 million. Initial use of proceeds was to replace our existing ABL facility, from which we had drawn $60 million as of the end of Q2. Including the option to draw on the second tranche of the facility we have an estimated total potential liquidity of over $200 million. We are thrilled with this financing and consider it to be a significant upgrade from our previous capital structure. While the interest rate on drawn amounts was previously lower, our previous ABL was a short-tenured facility with only minimal opportunity for incremental financing given its reliance on accounts receivable balances. Our objective was to obtain a larger amount of financing in order to ensure multiple years of liquidity comfort and the ability to invest as needed in areas of strategic prioritization. This facility provides that. While the rate on the initial tranche is higher than the ABL rate, we are excited to have the second tranche as committed capital at minimal cost. adjusted rate we are paying for $200 million of committed capital for both the drawn first tranche and the undrawn second tranche is approximately 7%. Lastly, we generated $14.5 million of adjusted EBITDA in the second quarter, a significant improvement over first quarter. The combination of our strong gross profit base and increasing levels of adjusted EBITDA profitability demonstrate the profit and cash generating potential of the business, especially as we generate more operating leverage over our operating expenses. The fact that we're able to generate such a strong EBITDA quarter, despite the headwinds that we have encountered this year, is a testament to the profit generating potential of the business as we reaccelerate growth.

Next, I'll cover our full year 2025 guidance.

For the full year 2025, we are updating the financial guidance that was previously updated in May. We are raising our full year revenue range to $818 million to $828 million, largely reflecting our positive Q2 revenue performance. We are also increasing our gross margin range to between 69.5% and 70%, and increasing the adjusted office range to between $562 million and $568 million. We are keeping our adjusted EPS between a loss of two cents and a gain of two cents for full year 2025, reflecting the incremental interest expense associated with the new financing. Lastly, we are also raising adjusted EBITDA to between $27 million and $33 million. We are not providing quarterly guidance. But please recall that the third quarter is seasonally slower than the second quarter. In addition, Q3 of 2024 will be an unusual comp due to a large, almost $9 million added period benefit in that quarter, which we did not expect to repeat this year, despite the fact that the underlying rate environment remains even stronger in Q3 of this year than it was in Q3 of last year. Now, let me turn the call back to Sam.

Thanks, Scott. Overall, Q2 results were positive and demonstrate the profitability potential of our business model. Strength in our core oncology HCT franchise continues, and an improving unaffected HCT business reflects progress with the EMR integrations. We think these trends will continue in the second half. Q2 also demonstrates the ongoing execution of our payer markets group, supporting more coverage of our portfolio, further supporting overall growth and profitability. The team is also excited to move forward with a clear, focused growth strategy. The priorities that underpin this strategy will go a long way to enhancing our focus and execution rigor across the organization. While we plan to provide additional details in the coming months, our updated strategy better positions Myriad to achieve its mission, advance health and well-being for all, and to positively impact an increasing number of patients while driving accelerated growth and profitability. 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 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 the Q&A session to ensure broad participation We're asking participants to ask only one question and one follow-up. Operator, we're now ready to take the Q&A portion of the call.

As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask that you please allow yourselves one question and one follow-up question only. please stand by while we compile the Q&A roster. Our first question comes from the line of Doug Schenkel from Wolf Research.

Hey, guys, and thank you for taking my questions. I really want to focus a couple on the strategic review. I appreciate all the qualitative details I do think it would be great if there were more specific KPIs that we could use to measure progress, both in terms of the near term and the long term. Is the intent of this update today to demonstrate, hey, we're making progress, we're working on this, but to basically make the point that the KPIs are coming soon? So that's the first question. The second is the language you're using seems to suggest that you've completed the strategic review of the portfolio. So should we, you know, essentially believe at this point there's not divestitures coming, you are happy with the portfolio plus the pipeline as currently built? And then last one, I will get back in the queue after this. A lot of what you described makes sense. I would also say, like, a lot of it sounds, you know, pretty unobjectionable. And I would imagine that would also be the case with some of your predecessors. They also wanted to grow more than the market. They also wanted to grow revenue more than OPEX. Things like that that, you know, make a lot of sense but aren't objectionable. What is the biggest thing that's changing here relative to previous administrations? Thank you.

Hey, Doug. Thank you very much for the questions. Appreciate it. You're spot on. Absolutely. This was intended to share where we are with the strategic review, the clarity on the pillars, what we're going to do, and that over a five year horizon that we believe the execution on these things will drive accelerated profitable growth, high single digit to low double digit. And yes, we will both be measured and we look forward to sharing details on KPIs and more specific details, as you said, in a more quantifiable way in the upcoming Upcoming months, it may be JP Morgan, but that's additional work that we're continuing to do. I think your second question was related to, are we happy with the portfolio? How do we think about divestitures? I mean, again, the work that we did gives us some real excitement about the strategy and being able to implement it to drive this accelerated growth. And as part of running the company, with increased rigor and discipline, we're going to periodically review all product lines, including GeneSight. to determine the ability to really support those strategic goals, right? So that's the we'll be approaching it. And third, about thank you for viewing what we shared today as non-objectionable. I think I'll take that as an endorsement. But very good point about what does this mean and what's going to be different. Listen, there's, you know, along with really focusing on high-growth market segments, our franchise in oncology has been an important one and a good one but it has been primarily hereditary cancer testing and HRD. It's expanding beyond that into these other high-growth applications, and being able to do that by its not all myriad through partnerships is an important change. Another important change is our stepped-up urgency, our rigor and discipline in how we're going to execute, and just really make it a high-functioning, high-execution company. And those are the things. together with adding the right team that really understand the space and the domain, I think is going to be the difference for really being able to deliver on the intent of our new strategy.

Thank you. One moment for our next question. Our next question comes from the line of Puneet Sudha from Learing Partners.

Yeah. Hi, Sam and team. Thanks for taking my question. So obviously, Genesight is, you know, was clearly an important product, a flagship product for you impacted here by the United coverage. But I know you talked about the feedback that you expected. in fall, but can you maybe talk about what has been submitted to United? Any of the early conversations giving you any leads in terms of when this can actually be resolved or not resolved? I mean, maybe just help us understand what should our expectation be? And just wondering, any of the other commercial pairs, are you getting any requests for further reconsiderations from other payers and have follow-up?

Yeah. Thank you, Puneet. Appreciate the question. I'll start and then I'll hand it to Mark to add additional details. So, again, we are happy that we've been able to, through the actions we've deliberately taken, you know, increase the growth of GeneSight back to where we, you know, expected it to be by year-end, which is mid-single digits. And kudos to the team for the refocus, the execution, and our rev cycle team and fair markets team, which continue to really drive opportunities with new payers. And then they handed off to Mark about timing and other things that you're asking. Nothing's changed on that, but I'll let Mark detail what we've shared in the past in terms of time points of what we're doing. Again, to dispel this point, we haven't traditionally had a lot of commercial payers that we have agreements in place with. And no, we haven't experienced that. Quite to the opposite, as you heard, I think, in Scott's prepared remarks, we're actually seeing a number of new, you know, carriers that are joining. So, Mark?

Yeah, thanks, Sam. So, Puneet, just to give a little color to Sam's last comment, which I think we stated, right, we've had several wins across different commercial payers, mostly related to biomarker laws, both in Q1 and in Q2. So we are seeing positive movement there for gene site, and it's across some commercial plans, as well as managed Medicaid and, of course, med advantage plans as well. Related to United, which we also said on the call, we plan on submitting three publications as part of United's typical review cycle, which takes place in the fall. Two have already been published, both in the Journal of Clinical Psychopharmacology. One was an economic utility study that we did with Optum. The other one is a new meta-analysis focusing on the randomized trials related to gene site. And a third is a sub-analysis related to the large prime care randomized trial that was done through the VA. So, we plan on submitting those in the fall. We would expect United to review those as part of the typical review process. So, we would expect to hear either status quo or potentially a change in that policy, November-December timeframe, which is when they usually announce, and the effective date would be the beginning of 2026.

Got it. That's very helpful. And then on MRD, could you confirm if the timing of the launch has moved from first half 26 full launch to an early access launch? I wasn't clear what I heard on that. Maybe if you can clarify. And what we saw, obviously, is all your ASCO data. Just wanting to understand what remains to be done the validation studies, any other studies that we should be expecting on MRD before you get into that early access phase?

Yeah, I mean, just to thank you for that question. We're continuing to make good progress on our MRD clinical studies that are underway, you know, upwards of 20 that we're working on. And, you know, by year end, we expect to have more clinical, you know, utility work that's done and to submit for Moldex by sometime in Q1, expecting Moldex, if they're with customary timelines, approval sometime towards the end of the year. We will, however, we're making a strategic decision because we think it's important to get our tests in the market so important providers can start using it to really, in the course of treatment of patients, we intend to do that in the first half. And so we'll be strategic in taking that out in advance, what is likely to be in advance of receiving Moldex. And, you know, because we're not going to do a broad, full commercial launch to everyone, that's why you might have heard us, you know, use the term early access, meaning focus still on, you know, quite a number we haven't determined yet of actual providers using it in the course of medical care.

Thank you. One moment for our next question. Our next question comes from the line of Dan Brennan from TD Cowen.

Hey, good afternoon, guys. This is Kyle. I'm for Dan. Thanks for taking the questions. I wanted to go back to the sort of mid to longer term guide here of high single digits to low double digits. You know, not too far off from, you know, where you were before 12 percent plus. But maybe you can just walk us through what the what the puts and takes there are across the portfolio here. You know, just given that, you know, you'll be layering in some new tests with MRD, et cetera, you know, how should we think about the different segments in the context of your guide?

Yeah, hey, maybe I'll start here. And, Scott, you can add in. And, Kyle, thanks for the question. And, you know, our intention is to share more details, more quantifiable numbers and KPIs, including, you know, more specifics around our growth rates, you know, over the coming months, including into JPMorgan. But what you can tell, even from the strategy, the way that we shared it, is if you look at our second pillar, which is about prenatal health and mental health, being able to grow at or above market, right? We know that the prenatal market is growing somewhere in the low to mid single digits. And we believe we're going to be able to go with that faster based on, again, the recent products we've launched and the excitement that we have for first gene, the new product that we have. GeneSight for mental health, we've already resumed growth back in the mid-single digits, and we are the market leaders there. We believe we can do that. It's really in oncology where we are seeing, again, really good growth in hereditary cancer. We have big markets here. We believe the combination of growing ourselves in the high single digits to low double digits in hereditary cancer testing, both across the combination of affected, unaffected, But then when you look at these new areas, which is an important net new, right, important part that we're trying to share, and the strategy is our intention through both the work we're doing, like, for example, in MRD, but through partnerships to enter into these other important segments, if you will, including IO therapy response monitoring, you know, more on comprehensive genomic profiling. These things will, you know, our products that we bring to market there ourselves or through partnerships really should grow. in the, you know, at least in the low double digits. So, it's that composite when you put it together, including prostate cancer, by the way. We're excited, again, about the partnership with Pathomic and OnTrack to launch that combined product, you know, our first combined product in Q1. So, all of these things, hopefully, I'll give you a little bit of color of how we can, we have confidence to grow high single digits to low double digits. Scott, would you add? It was pretty comprehensive there.

Yeah, I don't have any more details on the financial targets at this time, but I'll just reiterate Sam's comment that we weren't necessarily intending to provide a formal and fulsome update to our LRP right now. That will come at a later date, perhaps by the end of the year or the very beginning of next year.

Thank you. One moment for our next question. Our next question comes from the line of Yuko Oku from Morgan Stanley.

Hi, this is Jason for Yuko. Congratulations on the quarter and thank you for taking our questions. So maybe just a question on prequel. I'm wondering how has traction for the test been since the launch in 4Q last year? Has it been ahead of expectations or in line? And given the test differentiated eight weeks gestation age approach, have you seen any share gains from other players in the space? Thank you.

Hey, Jason, thank you very much for the question. Hey, Mark, why don't you take this one on a prequel and how it's traction and the interest of the eight week.

Yeah, look, I think, as we've said before, we're excited about the launch and we've seen tremendous uptake mostly because as we stated at that eight week timeframe is typically when that is the first prenatal visit. And so it fits very nicely within, within workflows. Um, so we have seen an uptick. We have seen volume increase there related to the test being ordered earlier. which is great. As far as our ability to be able to tease out the differentiations of stealing share, I think that's been a little bit more challenging. But as Sam mentioned, as we see growth there, we'll try to highlight that moving forward.

Thank you. One moment for our next question. Our next question goes to the line of David Westenberg from Piper Sandler.

Thanks for taking the question. Congrats on the quarter. And I'm sorry if I'm asking repeat questions. I've been hopping between some cues here. So I just want to ask on the prenatal, you mentioned the friction from the new management ordering system. Can you quantify that impact? And if you didn't already, and then steps to resolve it and how soon it can be resolved. And then just generally speaking, if you just want to make sure that when this thing kind of thing happens that it's not a switch in provider and can you give us a comfort on that? Thank you.

Yeah, I'll start and I'll hand it over to Mark. Hey, Dave, thank you for the question. I just want to clarify, you know, be very clear, that's a redundancy there, that the problem was related to an order management system. It has been addressed. So it's not like do we have, we not only have a beat on it, but we have resolved it. But Mark, there's other parts of the question, like, yeah.

Yeah, I think the other parts of the question, so again, we have resolved it, so we don't expect it to continue, at least from a system error perspective, to continue into Q3. From a provider perspective, look, many of our accounts use multiple providers, and so we see shifts throughout the quarter, so I don't know if we can quantify it. You know, I think our results this quarter and our excitement about prenatal products growing in the back half of the year pretty much reflect the way we feel about resolving the issue and about the strength of prequel, as the previous caller asked, around prequel at eight weeks, as well as the strength in our foresight product as well.

I'll just add to that. This is Scott. If you look at overall prenatal volumes, at least on a year-to-date basis, they're down about 4%. And so, You know, that is something that obviously is very different from what we'd normally expect for that line of business or that product category. We would expect something in the high single digits, the low double digits. And so that impact you can attribute to the disruption.

Thank you. One moment for our next question. Our next question comes from the line of Tico Peterson from Jefferies.

Okay, thanks. I want to probe into the guidance raised. Obviously, you lowered last quarter. Now you're raising. Maybe just for the back half of the year, how much is hereditary? Just talk about where the incremental step up is. Also, OPEX is going up. Curious about that, given, you know, some of the cost-out initiatives. And then, you know, I did want to probe on the LRP. I know you got the question earlier, but did anything change in kind of your end market growth assumptions relative to last fall? Thanks.

Hey, we'll go backwards, Tycho. Thank you for the question. In terms of your last question, no, nothing material. So it's not because we just were benefiting from a new increase of a market or anything like that. That's not it at all. It's again about, as I answered, you know, being able to participate in a meaningful way in other segments of oncology or the cancer care continuum, which we're not today, and strengthen our own products too, right? So those are the drivers there. You know, Scott, before I hand it over to you to answer a little bit more here, I'll say again that what has happened here in this quarter is we identified very clearly the challenges and the issues that, you know, were some of our biggest challenges in Q1. Again, we talked about, you know, changes we've made and the impact that it had related to gene site. We talked about unaffected red cherry cancer and, you know, workflow related issues including EMR. So we have been incredibly focused and the team's been working hard. And again, as I mentioned, I'm pleased that we've been able to execute and some of the results are exactly what we expected by the year end. So this is not by chance or not by luck. We have done the work to make it happen, but it's been a little bit faster than we expect. I don't know, Scott, if there was a quantification question to answer. Sure.

Thanks, Sam. We don't guide at the quarterly basis, nor do we guide at the individual product basis, but what we have talked about already, even on the last earnings call, was around the expectation of sequential improvement throughout the year in the areas that have been adversely impacted by some of these headline headwinds that we've referenced. when you think about the hereditary cancer testing unaffected journey that was one of the headwind items that we had flagged on our last earnings call where, as Sam was referencing, really excited about the incremental progress that we've made in accelerating volume growth in Q2, but that's not yet where we want it to be or expect it to be. And so that is one of the areas where you'd expect to see or we expect to see a further acceleration in the second half of the year. Similarly, the prenatal challenges that we're kind of newly referencing now, we certainly expect to significantly rectify in the second half of the year. One of the other areas that we referenced on the last earnings call was the near-term headwind in terms of gene site volumes primarily associated with the transition in the commercial organization there. We're pretty excited to have quickly recovered the volume trajectory there, at least within striking distance of where we expect it to land longer term. But those are the areas that we expect to see improvement and to deliver the guide for the second half of the year.

Thank you. One moment for our next question. Our next question comes from the line of Bill Bonello from Craig Hallam.

Hey, guys. Thanks. I guess I have a couple follow-up questions going back on the strategic plan. I'm just trying to wrap my arms a little bit more around the oncology strategy. I think I get it. You're saying you're going to add a bunch of additional products to try and grow in that channel, and you may do that on your own. You may do that through partnership. but maybe just talk to us a little bit about sort of your right to play in that market. What is it about your position in hereditary cancer that, you know, sets you up to have success in the other areas of oncology testing and, you know, help us think about, you know, how you might compete relative to the, you know, oncology testing companies that are already out there with multiple therapies, selection tests, and MRD, et cetera. And I have one follow-up.

Hey, Bill. Yeah, thank you very much for the question, Bill. I appreciate it. And it's a very important one. I mean, listen, what we believe we bring that's differentiating that we're going to be able to leverage includes, like you said, because of our hereditary cancer leadership being the gold standard in the market with that, as well as HRD, we have a reputation. We have a lot of trust. We also have access into thousands of the most relevant healthcare providers and systems. We also hear loud and clear through our primary and secondary research that increasingly healthcare systems and providers really want to down select to just a handful of providers that can provide them the most critical tests along the cancer care journey for a patient. So it's our ability, once we're there, we know that if we're able to provide other tests that are meaningful, that are easy to use and access that we have a right, along with the fact that we have heard, and this is something that we already have strengthened, is being able to provide a unified report, which makes it easier to interpret, excuse me, from multiple tests, that is, to help, particularly when you're thinking about a molecular tumor board, then you have that information that accelerates decision making. So it's those things, along with adding to our portfolio, and you know, focusing in where our strength is, right? We are going to focus in, for example, an MRD where we know our ultra-sensitive differentiated assay makes a difference to look at these low-shedding tumors, and we're going to focus in on breast because that's one place, and we all have an established, you know, reach, reputation, and trust with that community.

Thank you. One moment for our next question. Our next question comes from the line of Sabu Nambi from Guggenheim Securities.

Hi, guys. This is Rikki on for Sabu. Thanks for taking our questions. You got a few on women's health already, but wanted to see how the ramp for sneak peak has been going so far. And it's near almost year on the market. And if you've seen the goal of that funneling patients from sneak peak to prequel starting to materialize yet. And then also just wanted to revisit the strategic update here in the context of women's health and mental health. Could you just provide some more color on what's new here incrementally compared to prior comments in the last Investor Day? Thanks.

Yeah. Hey, maybe I'll take this. And Mark or Scott, if you want to add in, please do. But I mean, listen, our sneak peek business is one that strategic intent was really to complement, get in early on the cycle of engaging with a woman in her overall pregnancy journey, you know, quite honestly, it's been a challenge for us. And it's been an area that we still believe has a lot of potential. But, you know, given the areas we're focusing on, it hasn't been something we've spent a lot of time, the immediate time, you know, trying to optimize. So, you know, more on that as we, you know, have a chance to go into the next level of our own planning on our strategy. Your second question is, like, what's net new? It's a great question. Again, so let me just be very clear. For prenatal health, we believe that the recently launched products, it's not just the NIPS pre-equality gestational age, it's also the expansion we had to our foresight expanded carrier screening assay, as well as now the early access, which we launched in June for first gene, which is the combined screen, right, which brings the benefit of both NIPS together with carrier screening. Those things we believe will allow us to differentiate and grow at or above market. And on mental health, again, it's really a focus in on being able to execute with more precision on targeted accounts and continue to drive improvement in our overall payer markets and revenue cycle activities. One huge, huge, huge, huge important difference from before. is our absolute commitment to be deliberate in the level of resourcing, focus, and investment we will put into these businesses. It's going to be in a very focused, targeted way because our intention is to really focus in and grow the cancer care continuum business. That's the difference.

Thank you. One moment for our next question. Our next question comes from the line of Sung Gina from Scotiabank.

Hi, thanks for taking the questions. We'll ask one in the interest of time. I was curious in terms of your expectations for above market growth going forward, how much of it do you think will come from taking share away from others, your competitors, versus you know, you guys more efficiently penetrating into the kind of the under-penetrated segments of the market. Just given that there is, you know, significant deployment of EMR and things like that across the industry, I was just kind of curious, you know, how realistic is actual share gains in a more competitive market environment? Thank you.

Yeah. Thank you very much for the question. And I think the short answer is both, right? We are excited to be particularly around the cancer care continuum. We are participating in, you know, large, attractive, high growth markets. So, you know, the numbers we've shared overall, the five-year high single digit, low double digit is enabled by growing with the market there in those components. We intend to do better. So, you know, and that how we will do better is, again, the combination of our tests where You know, we can really win an account, provide value by having really compelling tests that come together in a report that makes it easier because it is true. Over time, the differentiation of a lot of the tests are waning. Not always the case, right? Again, in MRD, we believe we have a truly differentiated opportunity with a very low parts per million detection capability that we have. And then, you know, in GeneSight, we're going to grow essentially with the market because we are the market leaders there. You know, a very strong market position. Prenatal, we think we have an opportunity to grow. We absolutely do. The market's growing low to mid single digits. We intend to do better than that. Once again, because of those differentiated products we've launched recently and other ones we're going to do. Not to mention, you know, Brian Donley's joined teams, our new chief commercial officer, and a new perspective on stepped-up commercial execution that I think will complement the great work that Mark did beforehand.

Thank you. One moment for our next question. Our next question comes in the line of Brandon Cuyah from Wells Fargo.

Hey, thanks, Catherine. Sam, at a high level, you talked about wanting to increase R&D investment to support the cancer strategy. Can you do that within the current R&D investment run rate? How much is currently allocated to oncology, and how much incremental spend should we kind of anticipate there in the next few years? Thanks.

Yeah, great question. Thank you for that. Like we mentioned earlier, we're not providing specifics on financials now, but we intend to provide more as the months come, particularly heading into JP Morgan. But yes, to answer your question, we believe through deliberate management of where we spend our R&D dollars and growing R&D, right? This is based on You know another thing if you heard me say it's in the comments is we will grow revenue faster than operating expenses So still being very disciplined in how we do that overall So the P&L profile the company, you know continues to strengthen over this five-year period But we believe we can increase our investments in R&D and oncology in a meaningful way to achieve our Objectives and again, we will get the benefit. We don't have to develop it all ourselves some of it is will come through partnerships that enable us to get to market faster with a differential cost profile as well.

Thank you. One moment for our next question. Our next question comes from the line of Michael Ryskin from Bank of America.

Great. Thanks for squeezing me in. A lot's been asked already. I just want to squeeze one more in on some of the strategic issues pillars you talked about. You kind of talked of strategic partnerships a little bit more for some of these newer parts of the cancer care continuum. Just give us a couple examples of what that could look like, both from a what type of partner you'd be looking for, how that would develop. I realize this is sort of really far in the future, but just theoretically how we should think about that and what the financial profile of that might look like. That'd be helpful. Thanks.

Michael, thanks for the question. And hopefully... It's not so far in the future that it's a long time for now. I think the Pathomic relationship that we have for being able to leverage the AI capabilities that Pathomic brings together with our molecular assay for prostate cancer, Polaris, is an example. What we're doing, and at least some of the partnerships we're considering, is where the R&D or the product development capabilities of a partner will be complemented by our reach into the market, our reputation, our ability to really do all the way from ordering through delivery and support. And, you know, you can imagine that, you know, these relationships can be set up in a way where there are milestone payments and royalties to go along with it, but in a way that we think that we can, you know, achieve shared objectives in a way that's also favorable to Demerian's overall financials.

Thank you. One moment for our next question. Our next question comes from the line of Mason Carrico from Stevens, Inc.

Hey, guys. Thanks for fitting me in here. Sorry if I missed this, but I did not hear any commentary around precise liquid. So could you give us an update on where that product stands in the launch timeline there? And then, sorry to do this, but going back to the LRP, you guys have been making progress on RCM. You called out 49 new coverage policies or expansions year-to-date, even qualitatively. I know you may not want to talk directly to the growth rates, but how should we be thinking about the mix of ASP gains and volume growth that's kind of built in there?

Scott, I'll let you take the second one as it relates to precise liquid. Thank you for the question, by the way. You know, we're making a strategic decision. that we're likely not going to launch a precise liquid product that is, you know, based on the assets, if you will, that we acquired last year. Rather, we are, you know, excited about being able to serve the liquid biopsy, you know, comprehensive genomic profiling opportunity through a partnership. So those will be some of the things that we look forward to being able to share with our customers and all of you in the coming quarters. And Scott, please comment on the second question.

Yeah, so in terms of the question around kind of the composition of the LRP, I think what we have communicated in the past was that we thought based on the significant no-pay opportunity that we still have, even after all the great progress by our rev cycle and payer markets team, that we thought we'd continue to contribute 1 to 200 basis points per year from rev cycle and payer markets initiatives. Even with the strength that we are seeing this year, and we are very excited about it, particularly when it comes to the progressive position many payers and LBMs also are taking in terms of coverage for expanded carrier screening. Even with that, I don't think we'd be ready yet to move off of that longer-term expectation around 100 to 200 basis points.

Thank you. At this time, I would now like to turn the conference back over to Matt Scalo for closing remarks.

All right. Thanks, Gigi. And this concludes our earnings call. A replay will be available via webcast on our website for one week. Thank you again for participating and have a good rest of the afternoon.

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