Myriad Genetics Inc Q4 FY2025 Earnings Call

Good day and thank you for standing by. Welcome to the Myriad Genetics Fourth Quarter and Full Year 2025 Earnings 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, Senior Vice President of Investor Relations. Please go ahead.

Good afternoon, and welcome to Myriad Genetics Fourth Quarter and Full Year 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 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. Also joining us for Q&A will be Brian Donnelly, our Chief Commercial Officer. This call can be heard live via webcast at investor.myriad.com, and a recording will be archived in the 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 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 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. As we head into the new year, I'm pleased with the progress we're making as the new Myriad to live up to our significant potential by focusing on high-growth market segments, advancing our plans for multiple timely product launches, including leveraging strategic partnerships and by executing with stepped-up urgency and strengthened execution rigor. I'm happy with how we ended 2025 with fourth quarter revenue of $210 million, coming in above the high end of the preannounced range we provided in January. When you exclude the headwind from UnitedHealthcare's decision on GeneSight, our business grew approximately 4% over Q4 of 2024. In terms of testing volume, we delivered 382,000 test results in the fourth quarter. Our financial results were supported by continued strong volume growth for MyRisk in oncology at 14% over the year-ago quarter and MyRisk for unaffected at 11% over the year-ago quarter. These results reflect our ongoing efforts to enhance the customer workflow, including EMR functionality. Mark will provide additional color in his section, but certainly, we continue to see positive demand for our MyRisk hereditary cancer test, and this supports our accelerated profitable growth journey ahead. I'm also pleased to call out the acceleration in Prolaris test volume growth in the fourth quarter, where the combination of actions over the last two quarters, including incremental investments in the commercial team focused on urologists have helped drive 12% test volume growth year-over-year. Fourth quarter prenatal volume declined year-over-year, primarily stemming from Q2 order management disruption. With this issue resolved, we are now in an active rebuild phase, reactivating accounts, expanding access and driving new customer wins. We expect these actions to support a return to positive growth in 2026. Moving to our mental health business. GeneSight volume grew 9% year-over-year and continued to accelerate from the first half of 2025 as our commercial organization maintained strong execution with new and existing customers. For the full year 2025, revenue was $824.5 million, and we delivered over 1.5 million test reports by serving over 55,000 health care providers. Turning now to profitability. In the fourth quarter, we reported strong adjusted gross margin of 70% and closely managed our discretionary spend as reflected in our adjusted OpEx line. Ultimately, we reported a healthy adjusted EBITDA of $14.3 million and adjusted EPS of $0.04. We're also making great progress on our cancer care continuum strategy to maintain leadership hereditary cancer testing while expanding into other attractive cancer testing applications. This includes launching the expanded MyRisk panel in Q4, which has been well received in the market. We're also sharing results from an increasing number of studies in Precise MRD with positive clinical data presented at major clinical conferences. And we're in final preparation mode to start commercial testing of Precise MRD for breast cancer for a select set of customers in what we call an Alpha launch starting next week. Overall, we're making good progress towards our goal of expanding our portfolio of differentiated testing solutions that provide actionable insights across the cancer care continuum. From a new product pipeline perspective, 2026 is shaping up to be a banner year. Throughout the year, there are a number of important catalysts that we will be tracking that supports this year's growth. But even more, these are leading indicators of key growth drivers for 2027 and beyond. We're making significant progress on a number of catalysts outlined in this slide. Our strong fourth quarter test volume growth for MyRisk reflects ongoing traction of our breast cancer risk assessment programs and the launch of our expanded MyRisk test. We plan to launch disease-specific panels for MyRisk in Q2 and expect our market activation programs and product extensions to support increased MyRisk growth. Building on Prolaris' strong fourth quarter performance, we're on track to launch our first AI-enhanced Prolaris prostate cancer test in Q2 that combines the power of molecular and AI analysis, and this is based on our partnership with PATHOMIQ. On Precise MRD, as I noted earlier, we're on track to commence commercial testing for a select set of customers next week, and I'll provide additional color on the next slide. At the JPMorgan Healthcare Conference in January, we reconfirmed that our first Precise MRD test will be for breast cancer and announced additional indications that will follow. We plan to submit for MolDX and expand commercial testing for early access customers for both renal and colorectal cancer in the second half of the year with the commercial launch of breast, renal, and colorectal planned for 2027. All of these Precise MRD tests have a growing body of clinical validation, some of which has been shared recently in venues, including presentations at the San Antonio Breast Cancer Symposium in December, ASCO GI Symposium in January, where a first look at Precise MRD data related to colorectal cancer was presented by collaborators from National Cancer Center Hospital East in Japan, showing how the ultrasensitive detection of Precise MRD can have additional benefits compared to first-gen MRD tests. And to round out the robust 2026 pipeline, we're on track to launch the first gene multiple prenatal screen tests in the second half of this year. The timing of this launch dovetails nicely with the deployment of a focused prenatal health sales team next quarter and the expected early results of the CONNECTOR study in the next few months. As we prepare to achieve the important milestone of commencing commercial testing for a select set of customers with Precise MRD for breast cancer patients next week, I want to help frame expectations at this stage. This slide highlights our three objectives. First, we're looking to further showcase Precise MRD's clinical performance while continuing to build the body of real-world evidence. To date, data shows Precise MRD's high sensitivity and ability to detect disease down to 1 part per million. We believe our MRD platform can help guide clinical decision-making for patients in their journey in cancer care and has the ability to detect presence and recurrence meaningfully earlier than the standard of care with imaging and therefore, can positively impact patient outcomes. Second, nearly 85% of cancer care in the U.S. happens in the community. That's where Myriad has a strong established presence where we serve nearly 3,500 oncologists in 2025. We've seen strong interest from our community oncologist base to participate in the Alpha and early access stages of our commercial rollout. Clearly, this is an encouraging sign. But we also remain disciplined regarding the overall number of participating centers in these early stages of launch to ensure good customer experience and manage our profitability. We will look to expand the number of centers as we move through 2026. And the third objective is to track and learn from specific metrics appropriate for this early stage. After all, you get what you measure, and we'll look to provide an appropriate level of visibility into these metrics moving forward, starting with the Q1 earnings call. While we're excited and busy preparing for multiple launches this year, I want to reiterate that there is little to no contribution from these MRD tests in our 2026 revenue guidance. Going into 2026, we're taking a number of actions to accelerate growth. This includes our plan to invest over $35 million over the next few years to support a number of initiatives to accelerate organizational efficiency, agility and growth. These initiatives include strengthening our commercial capabilities, particularly in the cancer care continuum. Specifically, we're adding a meaningful number of sales and medical headcount ahead of multiple new product launches this year. Many of these new additions come from the advanced diagnostics sector and bring strong domain knowledge and experience in molecular profiling and cancer diagnostics, along with relationships across the oncology health care community. In addition, we're strengthening the tools critical to our sales team while implementing a comprehensive plan to drive awareness, excitement and demand for our products. I attended our commercial kickoff meeting last month hosted by Brian Donnelly, our Chief Commercial Officer, and I can say our teams are energized and highly motivated to win in the market. Now let me hand it over to our COO, Mark Verratti.

Thanks, Sam. Turning to fourth quarter oncology. Total oncology revenue was $84.7 million, growth of 2% over the fourth quarter of 2024. I would like to highlight our MyRisk test continues to gain share with fourth quarter 2025 year-over-year volume growth of 14% in the affected market and 11% in the unaffected market. Shifting to prostate cancer. Prolaris revenue growth in the fourth quarter accelerated to 16% year-over-year, up from 3% year-over-year revenue growth in our third quarter. Fourth quarter Prolaris revenue growth was driven by 12% volume growth, reflecting 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. Adding to what Sam mentioned in previous calls, Myriad is on track to be the only company that will offer AI, biomarker, germline, and tumor profile testing when we launch our first AI-enabled Prolaris test in the second quarter of 2026. In January, we issued a press release outlining our MRD commercialization timelines and clinical evidence presented at recent clinical conferences. Our ultrasensitive Precise MRD test continues to demonstrate strong clinical value in these studies, which now includes data on colorectal cancer patients, where we saw 100% baseline ctDNA detection across all patients. Approximately 20% of samples were detected at levels in the ultrasensitive range that may have gone undetected on first-generation assays. This supports strong performance of Precise MRD. As Sam mentioned, we're excited to begin offering our ultrasensitive Precise MRD test next week. Initially, this launch will be limited to a number of oncology centers, ones we believe best reflect a variety of needs across the community oncology setting and breast cancer patient. This early launch provides the opportunity to engage these providers and incorporate their feedback about a host of topics, including the ease of use and overall utility and actionability of the test. As we move ahead, we'll plan to expand the number of centers in a controlled manner until full commercial launch. Now moving to our Women's Health business. In the fourth quarter, Women's Health delivered revenue of $88.5 million, an increase of 2% over the prior year period. We're pleased to see another consecutive quarter of incremental growth in hereditary cancer testing in the unaffected market with revenue growth of 3% 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, such as the September integration of our MyGeneHistory assessment into Epic as a way to better identify patients that qualify for hereditary testing and improve the provider experience. So we continue to be optimistic about the potential for continued momentum. We also remain confident about our 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 2026 to fuel growth in MyRisk volume. As for prenatal testing in the fourth quarter, we saw a modest pullback in volume growth from previous quarters as we continue to work with accounts affected by friction created by the second quarter implementation of a new test ordering system. While we are optimistic our ongoing engagement will win back share and drive overall growth in 2026, prenatal volume growth in the first quarter of 2026 will face a difficult year-over-year comparison, likely leading to a decline in year-over-year volume growth. As for our new multiple prenatal screen, FirstGene, last week, we published the analytical validation of FirstGene in clinical chemistry. FirstGene is an integrated solution for multiple pillars of prenatal testing, and our paper shows excellent accuracy and reliability for each pillar. We continue early access clinical testing with our CONNECTOR study seeing positive enrollment momentum, and we are pleased with our turnaround times, assay performance, and early customer feedback. We are reaffirming our full commercial launch in the second half of 2026 and are investing appropriately ahead of this launch as FirstGene provides added insight and has the potential to expand the overall addressable prenatal testing market. Turning now to mental health. In the fourth quarter, the team generated GeneSight revenues of $36.6 million on volume growth of 9% year-over-year. We continue to drive expansion of the ordering provider base, achieving a record number of ordering clinicians to over 38,000 in the fourth quarter. This strong fourth quarter volume performance is worth highlighting as Myriad remains disciplined and focused on capital efficiency in this group. While quarterly revenue continues to be impacted by UnitedHealthcare's coverage policy change in January of 2025, we are proud of our clinical development and payer market teams for securing positive coverage policies across 12 payers for GeneSight in 2025 related to biomarker laws, including the California Medicaid program, Medi-Cal. In addition, we are seeing benefits from optimizing revenue cycle workflows to maximize reimbursement.

Thanks, Mark. As Sam and Mark highlighted, we're seeing clear momentum from the operational and commercial progress made throughout 2025. Let me start with a recap of our fourth quarter growth drivers. We generated another quarter of strong test volume growth in hereditary cancer testing, achieving 9% year-over-year growth in the fourth quarter and 7% year-over-year growth for the full year 2025. This acceleration in the fourth quarter reflects continued double-digit growth in our unaffected market. Likewise, GeneSight finished the year with strong momentum, generating test volume growth of 9% year-over-year in the fourth quarter and 6% for the full year 2025. This progress reflects commercial discipline and effectiveness of the actions taken in early 2025 in response to UnitedHealthcare's coverage decision. The re-acceleration in both unaffected hereditary cancer volumes and GeneSight volumes is a clear proof point that our commercial performance is strengthening and that the actions that we've taken to enhance focus, accountability, and effectiveness are translating into tangible momentum. Moving to the consolidated financial results. For the fourth quarter, we reported revenue of $209.8 million, above the high end of the range pre-announced on January 12 and consistent with the year-ago period. Overall, test volumes grew 2% year-over-year, while average revenue per test declined 2% year-over-year. The headwind in the fourth quarter average revenue per test reflects the impact from UnitedHealthcare's policy change with respect to GeneSight coverage. Despite the average revenue per test headwind, underlying demand continues to be strong. Excluding UnitedHealthcare's net impact on GeneSight of $8.1 million, our underlying fourth quarter 2025 revenue growth rate was 4% year-over-year. We generated 70% gross margins in the fourth quarter, in line with our third quarter, but down approximately 190 basis points year-over-year. This decline was driven by the revenue headwind I just mentioned that affected GeneSight's average revenue per test. Fourth quarter adjusted operating expenses decreased by $7 million year-over-year, reflecting disciplined cost management and the timing of investment as resources were deliberately redirected towards commercial and R&D initiatives that will ramp and be reflected in first quarter spending. We remain committed to balancing strategic investment to support our long-term growth with continued progress toward improving profitability while ensuring capital is allocated to our highest impact priorities. Taking all of that into account, we generated adjusted EPS of $0.04 or $0.01 above the year-ago period. Next, I'll speak to Myriad's profitability and liquidity. We generated $14.3 million of adjusted EBITDA and $17.9 million in adjusted operating cash flow in the fourth quarter. These results reflect the strength of our gross profit base, the operating leverage inherent in our business model, and the meaningful earnings and cash flow potential of the business as we continue to execute. We also maintain a solid balance sheet with access to $225 million in capital. As a note, we intend to file a universal shelf registration to replace our existing shelf. We view maintaining an effective shelf registration as a prudent corporate housekeeping measure. Next, I'll address financial guidance. We're reaffirming our full year 2026 financial guidance, which we issued on January 12, including a revenue range of $860 million to $880 million, and adjusted gross margin range of between 68% and 69% as well as an adjusted EBITDA guidance range of between $37 million and $49 million. In order to support investor modeling for 2026 by quarter, we provided additional commentary in the earnings release, and I would like to highlight a few key points. First quarter revenue is expected to be between $200 million and $203 million, representing 2% to 4% growth over the year-ago period. As happens in most years, first quarter average revenue per test tends to be lower than the fourth quarter due to items such as the resetting of insurance deductibles. In addition, as Mark mentioned, prenatal volume and revenue are expected to face unfavorable year-over-year comparisons in the first quarter, leading to a year-over-year decline in this portfolio. We anticipate prenatal to demonstrate year-over-year progress likely beginning in Q2. Also consistent with recent years, revenue in the second half of the year is typically stronger than the first half. We expect this pattern to repeat to a similar degree in 2026. This outlook is supported by current business trends and anticipated improvement in the prenatal portfolio and early contributions from recent commercial investments. As a result, we expect quarterly revenue to grow sequentially from the first quarter through the remaining quarters of the year. I also want to make investors aware that beginning in the first quarter, we plan to simplify how we present and discuss our business to better align with our refreshed strategy and how we're operating the company. Going forward, we'll organize our reporting around our strategic areas of focus with the first group being the cancer care continuum. This group will incorporate all hereditary cancer testing, including both affected and unaffected populations, and all tumor profile testing. This will be followed by prenatal health, which will include our NIPS and Carrier Screen lines as well as SneakPeek. And lastly, we'll continue to report mental health as a distinct category. We are making these changes because it provides clear visibility into the core drivers of the business and better aligns our external reporting with how we operate and allocate resources to our strategic priorities. We're confident in our full year outlook and the team's execution as we enter 2026. Now let me turn the call back to Sam.

Thanks, Ben. Let me conclude by saying this is an energizing time for the new Myriad. We are at an inflection point where we have the absolute clarity and conviction for our go-forward strategy with a particular focus on the cancer care continuum. We have a robust pipeline of new products and enhancements for attractive market opportunities, mostly developed internally but also complemented with ones enabled through strategic partnerships. Yes, we are the hereditary cancer company, but we are more than that. And many of these new products will strengthen our position across cancer care testing. Along with that, we're going to leverage our operational strengths for sample processing and reporting while expanding our commercial capabilities and customer reach. We have a stronger leadership team now, both from my direct staff and the next level with a needed blend of diagnostics, cancer, and genomics domain knowledge combined with proven experience for delivering results. Along with all this, we're taking steps programmatically and culturally to strengthen execution excellence. Put it all together, we have the substance and confidence to positively impact an increasing number of patient lives and to accelerate profitable growth. I now pass the call over to Matt for Q&A.

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

And our first question comes from Puneet Souda of Leerink Partners.

First one, maybe, Sam, given the momentum or the recovery that you're focused on for the full year, could you explain what gives you confidence that we can sustain this high single-digit long-term growth rate that you previously had and what you're forecasting for the year? How should we view 2027? Can we return to that high single-digit growth rate? Let me pause here, and I will follow up with another question.

Yes, Puneet, thank you for your question. First, let's discuss 2026. The factors driving our growth this year include several products we have launched, such as the expanded MyRisk panel last year. We are seeing improvements across our organization, both commercially and operationally, and we are enhancing our execution capabilities. Additionally, we will be adding headcount as we introduce new products throughout the year. Given our expectations for the recovery of the prenatal business in the coming months and quarters, we feel confident in staying within our guidance range for this year. Looking to 2027 and beyond, as I mentioned at the JPM conference in January, we have several growth initiatives in place. I would highlight our catalyst slide that outlines new products we plan to launch this year, including Precise MRD for breast and other indications, AI-enabled Prolaris for prostate cancer, and FirstGene. Timely launches of these products will significantly drive our growth in 2027 and beyond. In summary, we are confident that as we transition from this year to 2027 and 2028, we will achieve sustained profitable growth in the high single-digit to low double-digit range.

Got it. That's helpful. And then on the MRD launch, I appreciate the details you provided, but just wanted to get sort of how do you plan on holding back? I mean, is it certain indications just given the sort of competitiveness of the market and competition in the market and also the fact that currently, the products are not reimbursed, but you're on a path towards that. So maybe just talk to us as to sort of how you plan to throttle it back and then accelerate sort of into the second half of the year and beyond? And then on prenatal, if I could just squeeze in, how should we think about the growth rate in the first quarter? I know it's down but just wanted to make sure if there's a finer point on that and then the recovery through the rest of the year.

Yes. Let me take the MRD question, and then Ben, if you can answer the prenatal question here. Yes, from an MRD standpoint, we are excited again. As I said, it's next week, we're going live. We're going to start commercial testing, and it is for what we're calling our Alpha phase of the launch, in a select number. So we are being selective, Puneet. It is a little bit challenging in a good way that we've seen a lot of interest to have access to precise MRD, but I believe we can do it in a balanced way. I mean, again, in this phase, what we're looking for is input on the user experience all the way from ordering to the reporting, the number of repeat orders, the operational efficiency that we have, and ultimately, the order volume that we have. And as we noted, our MolDX submission is planned for early H2, so you can call it Q3 for breast and then later in '26 for renal and colorectal cancer. So until we have submitted for MolDX, we're going to be a little bit more careful on the volume we take on. But we have a path. And listen, it will be something we will carefully consider as the year goes by of are there merits to increase the volume? What do we think on the timing of MolDX? So as we sit right now, we're pleased, particularly with the start of Alpha for Precise MRD and breast next week. Ben, over to you on prenatal.

Thanks, Sam. So as it relates to prenatal, Puneet, as a policy, we don't generally offer product level revenue guidance. But we did call out the prenatal Q1 growth and the unfavorable year-over-year comparison because we had noticed that the Street revenue models had a pretty wide range as it related to our prenatal product. And so we thought it was important to be able to make sure that folks understood that appropriately reflecting our expectation as it relates to the recovery in 2026 is really the only major change needed to get Q1 revenue in line with our updated revenue range of $200 million to $203 million.

Our next question comes from Subbu Nambi of Guggenheim.

At JPM, you laid out an ambitious MRD launch roadmap, which you reiterated today. As you think about the puts and takes in that roadmap, where is there the most risk or the most factors out of your control that could delay your roadmap? And conversely, are there things that would go faster than what you planned?

Thank you, Subbu, for your question. When we consider this year, one of the main challenges, which could also be a positive aspect, is the number of samples we run in advance of MolDX approval for Precise MRD. Some factors, as you mentioned, are beyond our control, such as the duration and number of review cycles MolDX requires to provide feedback and ultimately grant approval. However, we can manage our preparations for the data submission for publication effectively. I’ve previously mentioned that we have over 15 active MRD studies in progress. The MONITOR study will inform our publication for breast cancer MRD, and we are on track to present that in Q3. The colorectal cancer submission to MolDX is connected to the pan-cancer study within the MONSTAR project we're conducting with our partners in Japan, and we anticipate that submission will occur in the second half of the year. Fortunately, in renal cancer, we already published a study in Lancet last September regarding renal cell carcinoma. These submissions reflect our confidence level and ability to manage certain aspects, but the timing related to MolDX is crucial. As you know, Subbu, we'll navigate this process together and see how it unfolds.

One follow-up. Last week, you published a paper of performance data for FirstGene in a prospectively collected set of patient samples. You reiterated the timing for the CONNECTOR study in the second half of this year, which will be based on real-world samples. Is there any reason to expect the real-world data set to have meaningful differences in performance of the test and the prospectively collected samples?

Thank you for the great question. We were very pleased with the results regarding selectivity and sensitivity from about 500 samples mentioned in the press release last week. However, until we have complete data from a broader set of individuals enrolled in CONNECTOR, we cannot make conclusive statements. That said, we have no reason to believe that the data won't be just as robust and compelling in terms of the performance for FirstGene.

And our next question comes from Tycho Peterson of Jefferies.

A couple on margins. So if we look at HCT volumes in oncology, you grew 9%, revenue obviously only increased 3%. Maybe just talk about what specific ASP or payer mix dynamics are driving this gap? And how do we think about this kind of dynamic in '26 as you launch disease-specific panels?

So Tycho, this is Ben. Thanks for the question. Yes, as we talked about ASP in Q3, we talked about that kind of the launching point for Q4 and then moving forward into 2026, I think it's important for folks to take into account that we anticipate a modest headwind relative to ASP when we look at the portfolio in 2026 when you're thinking about what the year will look like. As you mentioned, from a payer mix standpoint, as we focus on selling the expanded panel and then also the MyRisk more broadly across our sales channels, we've talked about this before where we have about a 10% lighter ASP in the unaffected channel relative to the affected channel. And I think that we saw that headwind across the portfolio from an ASP standpoint when you look at 2025, really driven by the different mix of payers. Part of it was biopharma revenue that we talked about in Q3 with the new baseline moving forward. And then another part of it is you just see a shift in the different payer mix from one payer group from a Blue Cross Blue Shield group to another group or something along those lines.

Okay. And then on Precise, I appreciate the color on kind of the Alpha rollout. Maybe just talk a little bit about how you think about scaling up on the sales and commercial channel there. Obviously, more of a '27 driver overall. But just talk a little bit about how you're thinking about hiring for the various indications.

Yes, sure. Maybe I'll start and then I'll allow Brian Donnelly, who's here with us to join in. I'll just say that the scale-up and the preparation for the launch have been underway for some time, and it includes training the existing team, making sure we're hiring people with the right profile, meaning understanding of molecular. And beyond just the sales team, it's also our medical folks, MSLs and a lot of that's already happening. But Brian, please?

Yes. Thanks, Sam. So just building on what Sam said, we're really focused on making sure we have the right level of reach and frequency to priority targets, which you won't be surprised to hear us say. So we're just taking a consistent view at the market, making sure that we are hiring the right level of folks in the right territories, and we're training them, which is a really important piece of the puzzle. We want to get them ready to go as quickly as possible to make an impact.

And Tycho, I want to add that we are allocating over $35 million over the next couple of years, primarily to expand our sales team. Those additions are already in progress. We recently had our commercial meeting kickoff, and there are many new team members who are experienced and have previously worked in similar roles, so they won't be starting from scratch.

Okay. That's helpful. And then maybe just along those lines and lastly, just on the Alpha launch, can you just provide any more color? You talked a little bit about how you're thinking about the number of tests you need to run, but maybe the customer profiles you're going to target.

Sorry, I didn't know if you got cut off. Did you just say can I provide any more color? Is that what you said?

Yes. On the Alpha launch, I mean, you talked about a number of tests you may target, but in terms of...

I'm going to go with that. Listen, we are...

Ladies and gentlemen, please remain on the line, your conference will resume shortly.

Yes. Apologies, Tycho. I got cut off. So I think what I was answering your question about Alpha is we're excited about the launch. We're starting off with a handful of community oncology centers. And by the end of the year, as we move into early access, we're going to broaden that into dozens of actual accounts. We have already done the training to prepare these sites. We have sample collection kits in their hands. So we're looking forward starting next week to activate fully and start receiving samples and can't share enough the excitement that we have to start.

My first one is on Prolaris, where ostensibly, you picked up some momentum into year-end. As you noted in your prepared remarks, the recent volume was up low double digits was because of the favorable comparison. Can you delineate between how much of it was the comp versus improved rep productivity or any other dynamics that you think are worth calling out? That's my first question. On an unrelated topic, my other question is on prenatal momentum into year-end. Units were actually down, I think, 5,000 or so sequentially in the fourth quarter. I just want to see if there were any remaining order management dynamics. And if so, how is that contemplated into 2026 guidance? And beyond that, are there other things that are worth talking through like competitive dynamics, for example, that may have affected trends into year-end?

Thank you, Doug, for the questions. I’ll begin with a question about Prolaris and then turn it over to Ben and Brian to address the prenatal topic. We have been engaged in several initiatives related to Prolaris over the past few quarters. This includes our interactions with key opinion leaders, various programs we’ve implemented, and the expansion of our sales team to reach more urologists. We believe these efforts will have a lasting impact. While it’s possible that we received some comparative benefit in the fourth quarter, we expect to see stronger growth in 2026 compared to 2025, even if it’s not at the 12% growth rate we experienced this past quarter. Now, I’ll pass it over to Ben and Brian to discuss the prenatal question.

Sure. Thanks, Sam. And I was just going to make one comment relative to Prolaris urology, Doug. So as Sam mentioned, we've focused on that channel executing with the sales force, and that gives us confidence as we look at 2026. So like Sam said, we don't expect, or we didn't model out a 12% year-over-year growth going into '26. The guide did reflect some traction relative to the total annual growth rate that we saw in '25 moving into '26, and we're bullish about the opportunity ahead as we see the performance that we saw in Q4. Now transitioning over to prenatal. You're accurate in the view that volume declined in Q4. Typically, Q4 is often a challenging volume quarter period, all else equal, not simply saying that, that is the year that we had for prenatal in 2025. But when you look at the seasonal or the quarterly volumes from a prenatal standpoint, oftentimes, you'll see a softening in Q4. We did see softening in Q4. And as we mentioned in the prepared remarks and then also, as I briefly shared with Puneet, our expectation is that we'll see a decline in prenatal year-over-year in Q1 with recovery in Q2 and beyond. And there are several things that give us that confidence. Part of it is having a focused sales force as they focus on our prenatal bag and Brian can speak more to that. The early traction that we're seeing in conversations with GeneSight and FirstGene, excuse me, as providers will be interested and open to conversations as we work to win back share as well. So I do want to emphasize the fact that the guide does not include a sizable benefit from FirstGene, but we do believe that as we launch that product commercially, we'll have an opportunity to have conversations with docs that will give us some traction or leverage across the portfolio.

It's Brian. I don't have a lot to add to that other than as it relates to where we're at now, we have a really good handle on our current accounts. We understand their needs. They are adopting our portfolio. We feel really good about our current customers and our relationships with them. So we feel like we are stabilizing there.

Can you provide an update on how many customers are currently impacted by the change? Are there just a few key ones, or is it more widespread? I would appreciate some insight on that. Additionally, which other areas of the portfolio might require updates to your systems? How are you managing those risks now compared to before this issue arose in prenatal?

Thank you for the questions, Andrew. Regarding the second question, we take this matter very seriously. We used the opportunity in Q2 of last year to thoroughly review every order we had to ensure everything was functioning properly, with no issues or friction in our ordering and reporting systems. What we've learned is that improving execution excellence requires a higher level of rigor in our testing before we launch anything. This was an error we caused ourselves, which we acknowledge, and we have resolved it. We have also examined all our other ordering systems and feel confident that they will continue to operate smoothly without any problems.

Building on that, as Sam mentioned, we are working to win back the customers who faced challenges, and we're seeing some progress there. I'll have Brian address that shortly. It's important to recognize that as we have the chance to reengage in conversations, discussing a new product presents an opportunity to initiate discussions that we haven't been able to take advantage of in the past few quarters. Again, I don't want to be repetitive, but this is one of the factors that truly excites us about our potential for year-over-year growth as we approach Q2 and beyond.

Yes. This is Brian. I don't have a lot to add to that other than as it relates to where we're at now, we have a really good handle on our current accounts. We understand their needs. They are adopting our portfolio. We feel really good about our current customers and our relationships with them. So we feel like we are stabilizing there.

Okay. Great. And then maybe if I can just sneak one more in. Just on GeneSight, you talked about the 12 payers and the biomarker bills that you added in '25. How should we think about the trend in ASP there for '26, knowing that you're past sort of the big headwind here that you've been facing for the last year or so?

Yes. So we've been really pleased to see the traction that's come as we've engaged in states with biomarker bills and the wins that we had in 2025. Those wins came across the year. And so there's going to be an annualized benefit to some of those that we didn't see in '25, but none of them in isolation are a sizable win. And so when we think about '26 from an ASP standpoint, again, across the portfolio, we're expecting a modest headwind. As it relates to GeneSight, we just think about it as being stable.

Ben, I want to build on your comments. Andrew, it's great that we now have a more balanced portfolio of payers. Unlike the situation with United, losing another payer would not be a concern unless it were Medicare, but we see no indications of that happening. We're in a stronger position now than we were before.

Maybe just on hereditary cancer. Can you just walk through a little bit kind of what's assumed this year for volume growth? You had some nice growth this quarter. I think comps are a little easier. Just wondering how we might think about the volume growth in hereditary cancer going forward.

Yes. So Dan, when we think about '26, we think about high single-digit growth from a hereditary cancer portfolio perspective, and that's across both unaffected and affected. Obviously, exiting the year with the momentum that we had continues to add how bullish we are about that, but that's how we're thinking about it in '26.

Okay. Maybe just on pricing. I think you said you have a headwind on the whole portfolio. Can you just give a little bit more color on that? Like is there a specific dynamic in '26? Or just how do we think about that?

Yes, Dan, I wouldn't consider it a specific dynamic for the portfolio. I would look at it more generally; as we face price pressure in hereditary cancer, we anticipate a modest overall decline in the portfolio of about 1% to 2%. There are individual dynamics for different areas in 2025. We will continue our discussions with payers and are optimistic about the ASP that FirstGene can contribute to our existing prenatal portfolio. Overall, when considering the enterprise ASP, we view this as a modest headwind of 1% to 2%.

Do you expect to gain coverage for MolDX and MRD in the second half of the year, and will that coverage contribute to revenue in your model? Sorry if I missed that.

No, Dan, we did not. We're not assuming that we would get coverage until sometime in 2027. So we're assuming really no revenue from MRD in our 2026 numbers.

A lot has been asked. But on FirstGene, I guess, what do you view as the largest practical barrier to scaling adoption and revenue for that assay in 2027? I mean, is it clinical confidence? Is it workflow integrations, payer coverage, sales execution? I guess, which barrier do you feel the most confident that you can clear early, which do you think takes more time?

Yes. Thank you for the question. I'm going to let Brian, if you don't mind.

Yes, sure. Thanks for the question. So with regard to FirstGene, for us, as you know, this is a new product. So it is really about getting the product in front of our providers, both our existing base as well as new customers we're interested in doing business with. And so it is going to be the traditional issue of getting folks aware of the product, making them ensuring they understand the product to a degree where they're willing to clinically adopt it and then pulling it through. There isn't like a particular issue here other than just really good execution, getting the product in front of customers and being there for them when they're ready to start using it with their patients.

Brian, if I can just add to that, I think that we've been pleased with the early access period that we've had so far, both in terms of input we've received from customers that have been using it, from our own operational efficiency that we've seen in a very high yield and also though it's still relatively early from the reimbursement that we've gotten. So all those things you mentioned, we're not going in blind. We have a pretty good sense of it. The other thing is we want to have higher market share, and we intend to in the coming quarters and years. But from where we are, we see FirstGene, particularly this combined screen as an opportunity to expand the market, at least for us and to go gain new share, and that's something that is really, I think, important to our future.

Got it. And then could you talk about the progress you've made in terms of cross-selling multiple assays across customers or really just growing wallet share. Are there any metrics you can provide to highlight how maybe an increasing percentage of your customers are ordering more than one test from the Myriad portfolio or any update there?

We will likely share more details as the year progresses. What I can say is that we are intentionally focusing on our sales organizations. For prenatal health, we are starting initiatives in the second quarter, which will be a significant focus with Prequel, Foresight, and FirstGene coming on board. In oncology, particularly in the urology channel, we are pleased to see an increasing number of customers using MyRisk, our hereditary cancer test, alongside Prolaris, as it's recommended in the ASCO guidelines for patients undergoing treatment for prostate cancer. Fundamentally, we believe that our established relationships in community medicine significantly enhance what we call the cancer care continuum since we are discovering relevant tests throughout the treatment process. We fully expect to see growing connections and benefits from being involved in these accounts. Thank you for the great question, and we will provide more information on this in the upcoming quarters.

And our next question comes from Bill Bonello of Craig-Hallum.

I want to revisit your answer to Tycho's question regarding the hereditary cancer ASP, and I have a follow-up on that. I understand the price difference between affected and unaffected groups, but the ASP decreased in both groups this quarter. Furthermore, you mentioned some challenges and pressures regarding pricing. I'm trying to determine if this is solely due to differences in payer mix or if your contracted rates for MyRisk are actually decreasing compared to previous levels.

Yes, Bill, I appreciate the question. So the short answer is no. We are not seeing contracted rates going down. We're not experiencing pressure in that regard as we have conversations with payers. Really, as we think about ASP, as I mentioned, Q3 is a reflection of the mix that we expected going forward. We saw that be consistent in Q4, and that's the way that I would think about it into '26, using Q3, Q4 as the ASP baseline, recognizing that in Q1 with deductible resets, there's going to be ASP pressure across the portfolio that will then generally recover through the remaining three quarters of the year.

Okay. And when you say mix, not necessarily mix between affected and unaffected but mix like payer mix.

That's correct. When you think about volumes coming from a particular payer versus a different payer versus patient portion.

Our next question comes from Lu Li of UBS.

I guess my first question on the MRD. I think you mentioned that you're planning to kind of like disclose some of like early-stage metrics. I wonder if you guys have like internal targets for like, for example, like per center utilization, like how do you measure success for those metrics?

Yes, that's a great question, Lu. Thank you. Among other things, we will focus on four key areas regarding user experience for those in the Alpha phase. User experience encompasses everything from how customers perceive ordering, turnaround time, result quality, and reporting, to how easy it is to interpret the information and take action. Repeat orders are obviously crucial; it's important to see that oncologists and healthcare systems continue placing orders for multiple patients. Regarding order volume, while we're not disclosing specifics, we are aiming to reach a certain order volume during the Alpha phase. Lastly, we will also assess operational efficiency, which includes our internal yield turnaround time, targeted cost of goods sold, and other related factors. These are the metrics we will be monitoring.

Sure. We've addressed the expectation that there will be a year-over-year decline. Additionally, when examining historical operating expenses from Q4 to Q1, we experience some outflows in Q1 due to the regular schedule of meetings and compensation changes. The combination of deductible resets at the beginning of the year, the impact of the year-over-year decrease, and a slight increase in operating expenses starting in Q1 and continuing throughout the year affects profitability in Q1. However, when considering the full year, it's crucial to recall that our historical performance shows stronger revenue in the first half. I've mentioned the effects of rising operating expenses, which we will manage as we gain traction with our commercial initiatives. We provided guidance on January 12 regarding adjusted EBITDA, and we remain very confident in that figure.

This concludes our question-and-answer session. I'd now like to turn it back to Matt Scalo for closing remarks. Thanks, Sam. 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. Operator, we're now ready for the Q&A portion of the call.

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