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And I would like to turn the call over to Matt Scalo. Please go ahead.

And I would like to turn the call over to Matt Scalo. Please go ahead.

Thank you, Franz, and good afternoon, and welcome to the Myriad Genetics third quarter 2024 earnings call. During the call, we will review financial results we released today. And afterwards, we will host a question-and-answer session. Our quarterly earnings release was issued this afternoon on Form 8-K and can be found on our website at investor.myriad.com. I'm Matt Scalo, Senior Vice President of Investor Relations. And on the call with me today are Paul Diaz, our President and Chief Executive Officer; Scott Leffler, our Chief Financial Officer; Sam Raha, our Chief Operating Officer; and Mark Verratti, our Chief Commercial Officer. This call can be heard live via webcast at investor.meriad.com, and a recording will be archived in the Investors section of our website, along with the 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 those 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. I will now turn the call over to Paul.

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss the highlights from our strong third quarter performance and provide an update on the progress we continue to make accelerating profitable revenue growth. We will also address how we are actively engaging with UnitedHealthcare regarding the importance of maintaining access to our GeneSight test. For those UnitedHealthcare enrollees struggling with the medication management challenges associated with depression, anxiety and ADHD. First, I want to thank my Myriad teammates and our provider partners for their continued support and commitment to advancing our mission and vision to make genetic testing and precision medicine more accessible to help people take more control of their health. We continue to deliver on our commitment to shareholders as we achieved a 11% revenue growth in the third quarter compared to last year, reflecting both volume and revenue per test improvements across the portfolio. Our focus on profitable growth continues as we generated approximately $150 million in gross profits, $14 million of adjusted EBITDA, positive adjusted EPS of $0.06 and maintain approximately $149 million in liquidity in the third quarter. At our investor event in October, we laid out the commercial growth strategy supporting our long-term financial targets, and provided updates on our product portfolio, including first gene, precise liquid and Precise MRD. We encourage investors to view our Investor Day presentation on the Investors section of our website for a deep dive into our product enhancements, new product pipeline and initiatives to better serve our customers and improve efficiencies. Despite a return to more typical seasonal ordering patterns and heavy storms and flooding in the Southeast that prevented patients and providers from testing, our teams delivered a strong third quarter. With this positive momentum in line and the strong pickup in volumes we have experienced over the last 4 weeks, we are tightening our 2024 revenue range target around the midpoint of $840 million, and we are increasing our 2024 adjusted EPS target to between $0.12 and $0.14. Last week, UnitedHealthcare updated its medical policy restricting access to multi-gene panel PGx testing. We believe that the existing body of clinical evidence for GeneSight including peer-reviewed research studies supports the clinical validity and utility of the GeneSight test. We were surprised by United's policy update because this topic never came up during our contract negotiations at the end of 2023, nor in subsequent meetings just 3 weeks ago. Additionally, the American Psychiatric Association updated its recommendations on PGx testing earlier this year, which should not change their long-held stance on this type of testing. GeneSight has a strong value proposition, which Mark Verratti will address further on today's call. And with approximately three million tests to date, we believe that primary care providers see the value in GeneSight as an important tool that helps reduce the costly and potentially harmful trial and error when working with patients to get them on the right medications for depression, anxiety and ADHD. We are engaging with United and Optum to try to find a resolution to this policy change and hope for an outcome in the next few months. GeneSight revenue associated with the United Commercial business was approximately $40 million for the 12 months period ending the third quarter of 2024. We want to reinforce that this policy change, if implemented, is effective January 1, 2025, and does not affect United's Medicare Advantage or managed Medicaid business, nor do we have any reason to believe that other payers are likely to adjust their medical policies, especially as biomarker laws in a growing number of states require state-regulated plans to expand coverage of PGx testing pursuant to national and local coverage determinations. And with that, I'll turn the call over to Mark.

Thanks, Paul. I would like to start with the product group. Myriad continues to lead the market with differentiated scientific insights offered by MyRisk Cancer Test. Last 12-month year-over-year revenue growth through Q3 of 11% demonstrates the continued growth of our category and our commercial capabilities during the period of continued dislocation in our sector. Despite a strong end to the third quarter, typical seasonal softness in July and August as well as our ongoing focus on profitable growth, which inhibits some of the volume growth in Q3. Investors should note that our Hereditary Cancer testing business includes both MyRisk and BRACAnalysis CDx. While we continue to see some strong growth in MyRisk with increased adoption and strong payer coverage, Hereditary Cancer testing growth was partially impacted by slower growth of our BRACAnalysis CDx business in the U.S. and internationally. MyRisk is expected to continue its strong growth as it benefits from expanded guidelines as well as an acceleration of EMR integrations, which play an important role in overall customer experience and revenue cycle management. We are on track to transition several large accounts, including several multi-state health systems, and we continue to expect to achieve double-digit growth in Hereditary Cancer testing volumes with stable average revenue per test in '25. Next slide. In the third quarter, our Women’s health team delivered 10% prenatal revenue growth year-over-year and 24% for the trailing 12-month period, excluding SneakPeek. While volume growth in Q3 was softened by typical seasonality, we continue to see growth from both current and new accounts. We believe the market is becoming more rational regarding market pricing for these services and continue to see strong growth opportunities with new customers as we move into year-end. Next slide. In the third quarter, GeneSight revenues increased 34% year-over-year as we reported volume growth of 10%. GeneSight revenue per test improved both year-over-year and quarter-over-quarter in the third quarter, reflecting a combination of strong provider demand, commercial pull-through and improving payer coverage driven in part by the growing list of states that have enacted biomarker laws and positive contribution from prior periods. Next slide. The critical need in mental health treatment is demonstrated by the fact that 96% of counties in the United States have an unmet need for specialty mental health care. This leaves the burden on primary care who provide over 70% of antidepressants. Far too often, this results in trial and error to find the right medication. GeneSight is an easy-to-use tool backed by strong clinical evidence including the largest randomized controlled trial in this space conducted by the VA. In that trial published in JAMA, both primary endpoints were met, including the GeneSight Group achieving greater remission rates over the 24-week period. The clinical utility and ease of use of GeneSight has driven an overall satisfaction to over 93% among its current providers. Next slide. We continue to see positive momentum with our Precise Tumor test, which we acquired in early 2024 and launched from our Salt Lake City facility this quarter. We are also excited to have launched Foresight Universal Plus in June and await ACOG guideline updates that could potentially expand this market opportunity. At our investor event in October, we spoke about precise liquid and MRD as these new products will provide tremendous value for our providers and support our long-term growth ambitions. Now I will turn the call over to our Chief Operating Officer, Sam Raha.

Thanks, Mark. As Paul mentioned, we hosted investors in New York this past October to provide a deep dive into our growth strategy and the enterprise initiatives that support our longer-term goals. Therefore, on this call, I'll keep my comments brief. Let me start on Slide 13 with an update of our Labs of the Future program. The overall objective of our Labs of the Future program is to drive innovation and operational excellence at scale to continue delivering high-quality testing results that meet regulatory requirements while shortening turnaround times and reducing our cost per test. The work we're doing on this program supports our ongoing focus to improve the overall patient and provider experience and also support continued strong gross margins. Over the last 3 years, we've invested over $75 million in state-of-the-art labs, standard-based technologies, and digital capabilities. In 2023, we completed the construction of our new lab facilities, both in Salt Lake City and South San Francisco. This year, in 2024, we made important progress at both sites, including with permitting, lab moves, lab validation, and operational scale-up. In Salt Lake City, we continue to ramp up volume of samples processed for both Prolaris as well as Precise MRD for clinical validation research projects. Precise Tumor, which is our therapy selection test that we acquired from Intermountain Precision Genomics, I'm pleased to report that we have completed validation of started processing samples in Salt Lake City as of last week. We continue to see monthly volume growth and expect this trend to continue accelerating as we head into 2025. In South San Francisco, we have completed validation and are ramping up sample volume for both Prequel, NIPS test, and Foresight, our expanded carrier screening test in our new lab. Based on our continued progress, we're on track of our plan to complete the South San Francisco move in early 2025 and Salt Lake City move by the end of 2025. Next slide. Digital capabilities continue to be a key focus area of investment across our enterprise to both improve customer experience and increased internal efficiency and productivity. Our efforts with EMR systems are making a difference in the way we're engaging with our customers and will be an important driver of future volume growth. It's clear that providers are seeking to integrate genomic and genetic information into the care of their patients and to provide the ease of use, this increasingly requires our products to be natively ordered and resulted in EMR systems. Over the past 2 years, we've doubled our investment in EMR programs, including an engineering, integration, commercial pull-through have seen an almost 10x increase in the pace of newly integrated clinical sites. In fact, we're tracking to integrate about 4,000 new provider sites this year. We have system integrations across 15 -- more than 15 different vendors, including strategic partnerships with EMR providers, including Athena, Epic, Flatiron for oncology and Lumea for urology. As we look at the first half of 2025, we expect to add iKnowMed and Ellkay EMR systems to enable for the first time healthcare providers and systems to be able to order the continuum of our oncology products from (indiscernible) line to somatic. Next slide. As we shared during our recent Investor Day, we see a meaningful opportunity for Myriad to serve community oncologists and health care systems who trust Myriad's gold standard hereditary cancer and HRD tests with Precise Tumor now and Precise MRD, a differentiated, highly sensitive MRD assay in the future. We continue to strengthen our freedom to operate and ability to deliver tumor-informed high-definition MRD assays with the issuance of the third foundational method patent from the USPTO, a personalized method for detecting circulating tumor DNA. In addition, our agreement with Personalis to cross-license patent estates cover tumor-informed approaches to MRD fortifies our IP position. We plan to launch our first MRD commercial offering for breast cancer, first half of 2026. Last month, we announced five ongoing research collaborations study the use of MRD testing in breast cancer using Myriad's Precise MRD test. This includes a study to determine whether circulating tumor DNA, level may predict the magnitude of response, the pembrolizumab and hormonal therapy in patients with HR-positive inflammatory breast cancer who did not achieve pathological complete response at the time of surgery. This is being led by Dr. Bora Lim, University of Texas MD Anderson Cancer Center. Another study is to evaluate whether ctDNA levels correlate with notable involvement in patients who have newly diagnosed HR-positive breast cancer and if so, how the correspondence may be used to aid in surgical decision-making led by Dr. Anna Weiss at the University of Rochester Medical Center, as well as a multicenter prospective study -- prospective study to evaluate the maintenance of complete response to trastuzumab deruxtecan in HER2-positive advanced or metastatic breast cancer patients and whether ctDNA can be used to optimally guide therapy being led by Dr. Yoshi Naito of National Cancer Center Hospital East in Japan. Across our studies, we have more than 4,000 patients receiving Precise MRD test. And with each patient having multiple draws, this will result in more than 30,000 time points, which will be an important part of the clinical evidence for our MRD test. We look forward to sharing data from our ongoing studies in the first half of 2025 and submitting data to MolDx in the second half of 2025 for reimbursement. We're also engaging biopharma companies that are currently running their MRD samples in our new Salt Lake City lab, where we bring together the power of high-performance MRD assay with our efficient lab workflows and cutting-edge infrastructure. We're excited about the sizable opportunity for Myriad to serve this market with our MRD assay as part of our precise oncology solution portfolio, enabling thousands of providers and health care systems that count on us serve their patients through the continuum of cancer care. I look forward to updating you on our progress. Moving on to our key performance indicators on the next slide. We continue to see a high level of teammate engagement across the company. The work we've been doing over the last couple of year’s increased internal efficiency and productivity is paying off. Compared to 2021, we're seeing a 75% increase in the revenue per commission sales rep and a 70% increase in the number of cases processed for customer service rep. Our ongoing focus on revenue cycle management is also continuing to pay off as evidenced by a 5% increase in revenue per test. We continue providing industry-leading test turnaround times to support providers making treatment decisions. Our turnaround times, along with the focus we're putting into improving customer experience and supporting our strong Net Promoter Score of 72. With that, let me turn the call over to our Chief Financial Officer, Scott Leffler.

Thanks, Sam. I'll start on Slide 18. As you've already heard from Paul and Mark, we're pleased with our continued progress in Q3, highlighted by our 11% revenue growth, increasing our adjusted EBITDA to $14.1 million and adjusted EPS improvement to $0.06 per share. While Hereditary Cancer testing revenue grew by only 5%, we were encouraged by 11% growth in MyRisk for the affected population, which is the area most likely to benefit from disruptions in the competitive landscape. We did benefit from a favorable change of estimates from prior periods in Q3 of '24, primarily impacting GeneSight. As a reminder, we disclosed a meaningful benefit in Q3 of last year from change of estimates as well. This year's change of estimate benefit was similar to last year's benefit on a consolidated total company basis, making it easier to compare consolidated year-over-year revenue. On a year-to-date basis, revenues across our three major product categories were even more impressive with growth ranging from 13% for hereditary cancer testing up to 26% for GeneSight. Next slide. As a reminder, we went into some detail at our recent investor event regarding some of the key drivers for sustainable progress in average revenue per test, including various investments and initiatives by both our revenue cycle and payer markets team. In Q3, we saw stability in underlying rates across the portfolio, which represents another proof point for the great work being done by our revenue cycle and payer markets team along with others throughout the company. On the next slide, I'll highlight some of the wins from these efforts. On Slide 20, we continue to see positive traction from these ongoing investments in revenue cycle workflow 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's 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 with Bluefield of California and Peach State Health Plan under the Centene umbrella, and there are several other payers with which we have had positive discussions regarding GeneSight coverage. In total, our team won 10 new product coverage or medical policy expansions from payers and executed seven contracts with new payers as we seek to bridge gaps in coverage across our No-pay universe during the third quarter. Those Q3 results bring us to 18 new contracts and 29 new coverage wins on a year-to-date basis. As I've 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 slide. As a reminder, we closed the sale of our European EndoPredict business during the third quarter. There was a onetime non-cash charge as well as minimal cash restructuring costs associated with the transaction. But it's important to note that the transaction removes about $11 million of annual run rate revenue. Importantly, it will be accretive by more than $4 million per year to our go-forward adjusted operating income by streamlining our cost structure. We had about 2 months of this impact in our Q3 results. Despite the impact of the transaction, we nonetheless delivered a solid 11% revenue growth on a consolidated basis and maintained healthy margins above 70%. OpEx remained modest, contributed to a solid bottom line performance with $0.06 of adjusted EPS. Next slide. Our 11% revenue growth in Q3 also translated into 11% year-over-year growth in gross profit dollars. On a year-to-date basis, we've generated 14% growth in gross profit dollars. Our adjusted EBITDA for the quarter was $14 million and is now $48 million on a trailing 12-month basis as of Q3. The combination of our generous gross profit base and increasing levels of adjusted EBITDA -- adjusted EBITDA profitability demonstrate the profit and cash generating potential of the business, especially as we generate more operating leverage over our operating expenses. We also finished Q3 in a strong liquidity position with $149 million of total liquidity from a combination of cash and cash equivalents and availability under our revolver. We saw sequential increases in cash and cash equivalent balances from Q2 to Q3 and expect to be free cash flow positive in Q4 as well. Next slide, please. Finally, before handing it back to Paul, I wanted to update our guidance for full year 2024. As a reminder, we began the year with a revenue guidance range of $820 million to $840 million. On our last earnings call, we updated that range to $835 million to $845 million. In light of our Q3 performance and continued execution, we are narrowing our full-year revenue range to $837 million to $843 million. Our updated gross margin expectation is 69.8% to 70.3% and our OpEx is now expected to be $565 million to $570 million. The net impact of these updates is a more favorable bottom line performance with adjusted EBITDA of $34 million to $39 million and an increase in adjusted EPS of $0.12 to $0.14. We have been pleased to have delivered solid performance proof points throughout the year and are also proud of these expected full year results. Now let me turn the call back to Paul.

Thanks, Scott. We continue to build on the pillars of long-term growth and profitability that delivered our strong results in the third quarter. The momentum we continue to see across the enterprise supports our decision to update our 2024 financial guidance. While the GeneSight medical policy change by UnitedHealthcare is disappointing, we remain encouraged about our future. As I mentioned earlier, revenue related to patients under UnitedHealthcare's commercial policies represent about $40 million in the most recent 12-month period. If the policy change goes into effect in January, we would expect a loss of about $40 million of revenue that would translate to approximately $30 million of lost gross profits. Our preliminary view is that we can mitigate at least $10 million of that bottom line impact. . In addition, we continue to believe that we can grow our remaining business at double-digit pace even after adjusting our budget -- our projected 2024 revenue for the loss of the UnitedHealthcare commercial revenue. Our clinically differentiated products supported by technology deliver value in real-world clinical settings and enable early detection and better treatment decisions for providers and their patients. Our modernized labs and commercial engines are examples of where investments in automation and advanced technology are yielding improved workflows, faster turnaround times, and reduce operating costs. All of this is reinforcing our position as a trusted and reliable lab with specialized expertise committed to quality and service excellence. We continue to energize the enterprise around our shared mission and vision to make genetic testing and precision medicine more accessible, helping people take more control of their health and to enable providers to better treat and prevent disease. I'll now pass the call back over to Matt for Q&A.

Thanks, Paul. 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 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 please ask only 1 question and 1 follow-up. Franz, we are now ready for the Q&A portion of the call.

So I'm going to, probably no surprise start on GeneSight and I want to start with a couple of math questions, and then I want to kind of get into a philosophical question for you, Paul. So United accounts for, I think, roughly a quarter of GeneSight revenue, presumably volume is about 15% to 20% and as we think about updating our models for next year, assuming this holds, I believe GeneSight gross margin is 75% to 80%. So I just want to make sure those are right from a math standpoint, and well, why don't I pause there and then I'll come back with a follow-up question.

Yes. So, Doug, tried to be real clear about the math. So of our $840 million of revenue that we expect this year, approximately $40 million of it is United Commercial, and we expect to be able to grow in double digits on that sort of pro forma base. We are still aiming for a 12% growth rate next year and beyond. We've said that that's our long-term growth rate. We are 4 days into evaluating this and most importantly, engaging with United on some additional data that we think they fail to take into account. More frankly, some interpretation of some of the information out there. So we're looking forward to continuing that discussion. We have a really great working relationship with United. This clearly kind of caught us out of the blue. And quite frankly, is inconsistent with typically how policy is made. Typically, some study would be issued that would say that the test is dangerous or problematic and so we're not really sure what gave rise to this policy change, but we're looking forward to those continued discussions and quite frankly, continuing to share with them the differentiating nature of GeneSight that I think sets it apart to some extent from other polygenic -- from other PGx tests. So that's the math that I would anchor you on. And we -- again, I wanted to give you a sense of the gross profits there of around $30 million and that we've already started putting our arms around at least $10 million of mitigation with respect to that and that's again, assuming 4 days into what we can do. So I hope that guides you on your modeling and gives you a baseline from which to think about 2025.

No, that's super helpful, and that's pretty impressive in 4 days. So we'll see what you do next week. On the philosophical question. So I understand the unmet need associated with GeneSight. That being said, going back to the time of the Assurex deal, which, of course, predates you. This has been a pretty consistently controversial area of focus for the company, at least in the minds of Wall Street and I think to an extent, in even the clinical community. The motivation behind the deal again, which -- it's not you, Paul, but it was questionable from the start, in my opinion, the way your predecessors cut data wasn't straightforward. All that said, I bring this up because in your 3-plus years with the company, you've done a commendable job of not doing these types of things. You stopped the lawsuits, you're really good with disclosure, you haven't been adversarial affairs, you've worked with them. Simply put, you've worked hard to optimize the good at Myriad and reduce the drama, and increase the predictability. Let me put aside clinical need and maybe be the jerky Wall Street guy for a second, but recognizing this is a quarterly financial call, GeneSight kind of remains the last fashion of drama at Myriad in the eyes of the investment community. And again, I think, to a certain extent, the clinical community what's the criteria you decide -- you used to decide if any asset, keeping GeneSight very much in mind should be part of Myriad 2.0, should be part of your business? Thank you.

Yes. Thanks, Doug. Well, first of all, let's underscore a big we here. The last 4.5 years has been a real team effort, including our Board of Directors and we have continued to deliver double-digit growth and now profitable growth for the last 5, 6 quarters, and we're committed to continue to do that. And I appreciate your kind words. We have divested those nonstrategic assets. We've just completed, which was a little noisy in Q3, our international restructuring and despite that, we delivered on the 11% growth and quite frankly, a nice beat on the EPS line, too. Look, I will tell you there are thousands of patients, three million patients out there, including a number of personal stories that I can get into off-line of people whose life has really changed because of the GeneSight test. There is nothing more painful than watching your teenage daughter struggle with depression, anxiety and going through the trial and error of 3 or 4 drugs over the course of 18 months and the weight gain and the loss productivity -- and so we're looking forward to sharing more of that data in clinical utility with United, including the work that we've done with Optum, and try to better understand this policy change. But I can tell you that our GeneSight team and the 500,000 patients this year that are going to benefit from getting on the right medication faster, we're not going to abandon them anytime soon.

And your next question comes from Tejas Savant from Morgan Stanley.

Hi, this is Madison on for Tejas. Thanks for taking the questions. I just wanted to start-off, I guess, in light of the body of evidence for use of multi-gene panels and mental health disorders being relatively less mature than, say, for like oncology. Do you think that there is a risk that payers who are facing growing headwinds on the cost structure will view the field as kind of like low-hanging fruit to deny claims or raise the bar for prior auth?

Well, I think that we acknowledge that the payers, it's their turn in the cycle here, and they're facing under enormous profit base, by the way, a fair amount of pressure. So -- and that there's a downstream effect on that and there's a great deal of scrutiny, bipartisan scrutiny on prior authorizations and a number of their practices. Again, we've worked really hard with United and others to be transparent to work through coding changes and we're going to continue to do that because I think that goes to the underlying integrity of our revenues and our business model. But there's no question that the pressure gets extended like everybody else in the health care ecosystem. It is also true that we've had a disciplined approach to managing our costs, which is important here as well in terms of improving the value proposition. The data and the evidence that we see for GeneSight, quite frankly, is that it improves the MLR that when you look at the other costs associated with patients, whether it's their primary diagnosis or secondary is that whether you're talking about the elderly or a person they're working years or a teenager that depression, anxiety, ADHD have enormous personal and financial cost to the system. And so again, we're going to continue to build that body of evidence. But we think in the context, and I have a fair amount of experience in this in terms of looking at the total cost of care and the MLR of a payer that people would be shortsighted to not use the GeneSight tool as part of the process to get people on the right drugs faster and improve their overall treatment process.

Got it. Okay. That makes sense. And then maybe one other one. I know you've kind of touched on this before, but just wondering if you've had any inbounds from other payers following the United decision and then more specifically, what had your revised long-term target assumed by way of improvement in the GeneSight no pay rate over the next couple of years?

Well, no inbound. And again, we continue to -- as Scott pointed out, and I've talked about over the last couple of years, we view reducing our no-pay has a lot of ground game, the small wins that are adding up. Most of those wins have just been in the last couple of quarters, so you're not even seeing that yet. Many of these, say, biomarker laws just went into effect in July. Some are just going into effect in January. And it takes months, if not a year, to make it into medical policy and make it into contracts. So it is, as we've articulated before, a slow process. The biomarker laws are not tied to United's medical policy. They are tied to national coverage determinations and LCD specifically. And so again, we don't expect that to impact our ability to continue to reduce no pay for GeneSight. And, quite frankly, continue to grow GeneSight. And again, we'll look forward to hopefully affecting this policy change at United. In terms of our long-term growth, I think I've sort of spoken to that. Certainly, that we will continue to revisit that, but we are confident in our ability to continue to grow our revenue base, our pro forma revenue base on a double-digit basis, and continue to grow profitably as we continue to get the productivity gains of our lab of the future and see the rest of the leverage in our P&L that you really saw this quarter and the drop-through that is happening across our P&L.

And your next question comes from Puneet Souda from Leerink Partners.

Paul, so just wanted to clarify on GeneSight. Could you please confirm the Medicare rate there? And as you pointed out, that would become the larger portion of the mix and as a result, only about half of the impact on the bottom line. So I just wanted to confirm that. And then on the payer side, why would we not expect to continue to see more pressure from the payers because they themselves are experiencing and other pressure in other areas. So why wouldn't we expect that on other parts of the portfolio or any conversations that you've had on that end?

Yes. Let me start with the last, Puneet. As I said a few minutes ago, the whole health care system is going to see continued pressure. I think our sector is in a little different position because adoption rates are still pretty low, and we have significant no pay across our portfolio, whether it's in prenatal or for hereditary cancer, and you've seen progress across the board there. There are many payers that only cover back in terms of hereditary cancer, for example. So I think there's more than enough upside to improving our ASP, notwithstanding the global pressures and we're not seeing, and we've talked about this year-to-date, we haven't seen any contract pressure, pricing pressure in any of our discourse with payers. That has not come up. Our Medicare rate is $13.56 for GeneSight. And again, while -- again, this is disappointing, and we're working through this, again, 4 days in, we don't see this having an overall impact on our ASP opportunity over the next few years. We think that across our portfolio, we have 3 or 4 to 5 more years of opportunity to expand medical policy to improve rev cycle and reduce no pace.

Got it. That's helpful. And then let me switch away from GeneSight. There was an acquisition in the space on the hereditary side, just wondering how are you thinking about the competitive landscape. You're obviously taking some share with the disruption in the marketplace. Now with this acquisition, just wondering how you're thinking about Myriad's position and potentially maybe even ability to take share?

Yes. Thank you. I'll start and then turn it over to Mark. I think you probably all have heard enough from me already. But the recent changes in the marketplace in BT, Semaphore, and now the transaction of Ambre all create opportunities for us to gain share as a respected and quite frankly, the leading provider of hereditary cancer test. This is both for affected patients in oncology and particularly for unaffected patients principally in our women’s health channel. So as I've said throughout the year, these changes take time even with respect to the most recent change in (indiscernible) and LabCorp, the policy changes are just taking us into effect now the integration is just going to happen here in January, as I understand from some of our field people. So I think 2025 is going to be a great year for us to win share, particularly as we land these large accounts, continue to advance our EMR integrations, continue to expand our MyRisk panel that we've talked about at the Investor Day. So I weren't quite bullish on our opportunity to grow MyRisk our Hereditary Cancer tests across all of our channels in 2025. Mark?

Yes. The only thing I would add to that, just to echo Paul's comments, on the unaffected side are our Women’s health channel, Myriad is, by far, the market leader and we don't see much competition there. I think on the unaffected side, clearly, MyRisk is considered the gold standard test. And any time we've seen this dislocation that opens up different providers and health systems to now have to make a choice because they have to remove a product. So that means it opens up a choice for Myriad to get into that account. In addition, it takes a long time for these integrations as we've sort of talked about, right? We would expect those to be a lot quicker but unfortunately, when you're trying to integrate a test like a hereditary cancer test, it does take a long time. So that's that move from one competitor to another doesn't happen overnight, but it really does open up a lot of opportunities for Myriad to be back in there, selling the best-in-class test. And so similar to what we've seen with the previous dislocation, we're going to take this opportunity to really focus and to get back in there and win share.

There's a war room already stood up on in [indiscernible], I promise you. .

And your next question comes from Prashant Kota from Goldman Sachs. Please go ahead.

Hey, guys, this is Prashant on for Matt. Congrats on the quarter. Sad to hear about the GeneSight development, but I was wondering how you're thinking about the time line of further dilution of pay rate from the addition of new products. For example, would you ever consider staggering the launch of certain products to avoid dilution of the no pay rate all at once, which could potentially affect margins? And then I have another question on MRT, but wanted that first.

Yes. That's a really great question. I actually spoke about this at a panel recently with our friend, Doug who was on the line earlier. The industry's great opportunity here is to close the gap between science and the great innovations happening in our labs and medical policy. But in between there are guidelines and whether we're talking about prenatal tests or guidelines for oncology products, we got to close those gaps. Now I think we're -- as part of our product management here, really trying to be thoughtful about how we go to market with products like FirstGene. In fact, our discussions with United around MRD are right around this topic that we would expect to continue and so we certainly expect that as we launch new products like everyone has experienced, some no pay, some even margin degradation. We have plenty of other ways to continue to maintain margins. But ultimately, we want to close the gap between launch and payment, but you will see that in FirstGene, you will see that over Precise Liquid and we've been pretty open about those things. The strength of Myriad Genetics, though, is the diversity of our portfolio and the many different levers we have to pull here to grow profitably. Sam, I don't know if you'd add anything to that.

I think you said that very well, Paul.

Yes. Got it. That's helpful. And then just playing devil's advocate, if -- what is the revenue contribution from MRD for some reason, takes longer than expected. Do you still feel confident in achieving that 12% plus long-term guide for top-line growth?

Yes. We have said consistently, I'll underscore this, that our long-term growth target is based on our core portfolio of products, including the enhancements we're making to those products across the portfolio. We don't expect contributions for FirstGene to get us there. We don't expect contributions from Precise Tumor, Precise Liquid to get us there, and we certainly don't expect MRD. Those products, we hope and expect, as we think about '26 and '27 start pointing us to growth in the mid-teens. And again, with many different levers to maintain our 70% gross margins.

And your next question comes from Subu Nambi from Guggenheim Partners.

Clearly, the UnitedHealth decision was a surprise. One of the things that made it all the more surprising is that as United’s affiliate, OptumHealth was a key group that generated health economic data supporting GeneSight use. Does this relationship actually help you as you engage with United on this or does this make the decision all the more challenging given how close United should be to how this data was generated?

Well, I think United is a big complex organization, and that's been incredibly successful, one of the more successful health care companies in America, but it is quite a big complex organization and not really sure if they took that health economic data into account. But I assure you, when we sit down with them in the next couple of weeks that data is going to be shared. As we've said previously, there is no doubt that GeneSight contributed to some of those savings. That's clear from the Phase 1 study. So we'll be reviewing that data along with the additional GeneSight specific meta-analysis that was recently completed. And again, part of what I think we're going to discuss with United is the difference between GeneSight and some of the other PGx test out in the marketplace and that differentiation, both in terms of clinical utility and clinical validity. So we can't tell you exactly what -- we've read the policy just like you have, but there's more to talk about, and we're looking forward to those conversations and having a more holistic conversation. And that's probably what's disappointed here that the position of other stakeholders wasn't taken into account. And again, that there wasn't some big study that was recently released that would have given rise to this policy change. So we're really scratching our heads about this, but we'll know more in the weeks to come once we sit down with them.

And just to address the elephant in the room, what gives you the confidence that other payers won't pull their coverage for GeneSight, especially payers are always looking for an excuse, do not pay for that, especially diagnostic? So just anything, any sign, I know you said about the personal stories and the data that's out there, but you were all out there even when United took that decision. So just trying to see how are you planning to mitigate that.

We're not offering a guarantee here. What we are saying is those other coverage determinations were not based on United's policy. They're based on local coverage determinations and we are obviously -- we've talked about this before. We are always trying to build the clinical evidence across all our products. And while the company fell behind on those research and those clinical studies, there's been a great deal of work over the last 3 years, and you've seen this at various conferences to bring forth more clinical evidence to support our test. That's an ongoing obligation and commitment that we have. But we have no reason to believe that there will be changes in other payers' coverage determinations or policies. That's not to say, as you and others have pointed out, that payers might not look to this and attempt to do that. It's just inconsistent with how medical policies have been underwritten to date, and it would be a big departure from their contractual obligations to look to this policy to make a change here. 4 days in that's the best we can tell you.

Okay. And your next question comes from Sung Ji Nam from Scotiabank. Please go ahead

Paul, I may have misunderstood your comments earlier, but do you have a sense of what additional data they're looking for at this point or if they provided any kind of specific end points or metrics or size of patient cohorts they're looking for? Just trying to better understand kind of what's missing from their perspective?

We're not quite clear on what's missing, quite frankly. But again, we have a good working relationship with the team at United and we are scratching our heads about how a policy change was affected without some study being released that pointed to the negative aspects of these tests, and including from the different societies and others. So again, we're looking forward to sitting down with United and understanding what gave rise to this policy change because, again, we don't see the trigger for it, but I can't speak for them. So, again, we look forward to having that conversation and presenting the additional data that was not presented in the policy statement that we think should have been taken into account. So that's the clarifying point. We do have additional data. And we think that the input of stakeholders is going to be important here. We don't think that this policy change allowed for getting the stake -- the stakeholder input from providers and patient advocate groups about GeneSight or the other test. So we'll have more to share after we sit down with United. But I don't want to prejudice those conversations, I want to go into them listening and learning, and hopefully, they will respond in kind to be open to the data that we want to provide and the additional input from other stakeholders.

Got you. And then just curious on that note, trying to assess the best case scenario -- work scenario, maybe the work more obvious. But best case scenario, do you think something like this after presenting additional data is something like that could be resolved within the next year or would be kind of the earliest we might know is kind of the next decision cycle for United from their coverage perspective. And then also just curious if the United Health portion of your GeneSight business has been growing at kind of roughly the same rate as the rest of the business or has it been growing faster in over the last few years?

Sure, Mark, do you want to take the last one, and then I'll take the first one.

Yes. So the latter part, yes, sure, correct. The United business has been growing at a very similar rate as the rest of our business, actually, maybe a little bit more just because of the focus that we've had on profitable volumes versus the no pay reductions that we've talked about earlier.

With respect to our hope that United might modify this most recent policy, we can't speak to the time frames around that. But we do think that there is enough here for them to revisit the policy potentially to spend it while they evaluate more data and more stakeholder input. So the best case scenario here is that they put a pause button on the January 1 effective date, and take another year to evaluate the data and stakeholder input. And I think we've given you the worst case. We believe we can mitigate a lot of this, not all of it. We're certainly going to come to work every day beginning January 1 to address this policy and grow through it. But I think we wanted to give you sort of a pro forma view of what we think is the worst case, and how we approach it. And despite this, we're going to grow next year. And so I think that's the part that I would underscore for investors about our ability to continue what we've done in the last 4 years, which is disciplined, transparent execution and delivering on the commitments that we make to you all. So, unfortunately, we've had to reset that pro forma base, and we'll go from there.

Okay. And before we proceed to the next question, again, just a friendly reminder, we will just be having one question and one follow-up per participant only. And your next question comes from Rachel Vatnsdal from JPMorgan. Please go ahead.

So I wanted to dig in a little bit more on GeneSight again. Specifically, just on the actual market size for pharmacogenomics, so at your Analyst Day a few weeks ago, you talked about how the market size is $2 billion. You said that was based on the most updated data that you had at the time. As we look at the year before, you guys had really pointed us towards that $5 billion actual market. I know you talked about how some of the underlying data are just working with what the best you had at the time. But can you break down for us what really changed in that underlying market data. And then I appreciate that you're working with United to try to reverse the decision. But as it stands today, does that give you a further change in terms of your current view of the $2 billion TAM that you provided a few weeks ago?

I'm sorry, we will sit down with you and (indiscernible), our market expert. And Matt, I'll commit to you that they will sit down with you and go through the TAM data that we have. And as we said at our Investor Day, that's the best data that we have. Look, I would just say more importantly, generally, that there's a tremendous amount of interest in pharmacogenomic testing. The medication areas in America are pronounced across many different indications. Tough flooding right here, being the early leader in PGx testing. But we get calls from physicians all the time across a number of indications of the need they have for further guidance on medication administration. And in my prior life, I will tell you that so many hospital readmissions were being driven by improper medication administration, particularly among seniors. So we -- this goes back to the first question from Doug. Long term, we think this is really important for American Healthcare and for Myriad Genetics and there is a long-term opportunity here to continue to look at other indications, build a better body of evidence, work with other stakeholders how we can be part of the solution to do better medication administration and you look at the rise in specialty drug costs across the MLRs of payers, it's a problem, it's an issue. So whether the TAM is $3 billion or $5 billion, we will get back to you on that. I think the bigger thing is there's a real need to bring more science to medication administration and that's part of what we are committed to here. And we think there's a real long-term opportunity for us and for our patients here at Myriad Genetics in this regard.

Fair enough. Maybe just then shifting over to the women’s health side. So you've talked about how there's some dislocation in the market given current competitive dynamics there. So can you just give us an update where we are in terms of Invitae exiting the market there? How much more greenfield opportunity is for you to kind of compete on some of that share? And any shift expectations you expect going forward?

Yes. I don't know if I could put a number on it, but I would still say that there is still a lot of disruption, right? I think when you think about, as I mentioned earlier, accounts are still making choices and in some cases, accounts made choices because they were forced to move quickly. And so they may have chosen another lab, and now they're evaluating that lab and they're not happy with that particular service. And so we are still continuing, as I commented, on winning new accounts, and in many cases, in the women’s health space, it is about stealing share. It is about providers making choices. And so I still think there's a lot of green space for us to win back and retain share as well as other competitors that are in the space because as we continue to improve our products, as we continue to improve our ease of use, Customers do believe that Myriad has had some of the best-in-class tests. And in some cases, it was because of ease of use. And now that we're doing EMR integrations, and we're doing other investments, we are in a very strong position to continue to win back share from other competitors.

Yes. Look, I'm going to just actually get, yes. I mean the opportunity in prenatal for Prequel, for example, our NIPS test that we're going to be launching at 8 weeks to gestational. That's big, particularly given all the reproductive rights issues in America today, having an answer at 8 weeks and not having the failure rates that many of our competitors have at 9 or 10, that's big. We are -- that gives our folks a differentiated experience and Prequel is more accurate with Amplify, and we have less failure rates at first pass in terms of blood draws. So that's an opportunity. Moving to average risk has moved -- has lifted all boats in terms of prenatal testing and that's even before we get the carrier screening and a potential ACOG guideline expansion and our prelaunch of Foresight Universal Plus. So in the prenatal space, it's narrowed to three, four, five different providers, we have a lot of white space to gain share, but also participate in the expansion of guidelines and adoption, particularly in a lot of underserved communities. The real secret sauce though, as Mark pointed out, is the ability to bring MyRisk with risk score and our newly recently launched breast cancer risk assessment program into that channel. And so I will tell you that one of the things that we're most excited about, not only is the prenatal in women’s health, but doing more, particularly with breast density being an issue and FDA guidelines expansion, bringing more of our MyRisk test with risk score that is not available for anybody else for patients of all accessory into that women’s health channel. Lots of opportunity in green space for us there.

And your next question comes from Brandon Couillard from Wells Fargo. Please go ahead.

I have a couple of questions for (indiscernible) firm impact you alluded to volumes coming back pretty strong in the last few weeks. I just wanted to make sure there's no hurricane effect. And is the prior period revenue benefit in the third quarter? Is that $7 million? I think that's about what it was last year?

Brad, I'm sorry, I might need to ask you to repeat the first part of your question. But yes, so I mentioned in my prepared comments that our prior period impact benefit was similar to last year. Last year, it was around $7 million. This year, it was a little over $8 million. If you can receive the first part of your question.

Yes, I was asking is just the implied fourth quarter guide embeds any headwind from the hurricane disruption. I think Paul talked about volumes coming back strong in the last few weeks, but I wanted to make sure there's that's the case?

Yes. I think we're pleased to see a normalization in volumes, but -- and so now, the Q4 guide doesn't assume any kind of particular weather-related headwind coming at us.

Okay. Last question. You've got a -- looks like a EMR of site integrations planned for the fourth quarter. Can you just remind us how quickly you start to see pull through when those new sites come online and whether we should maybe be thinking about the first quarter perhaps having less of a step down, less seasonality in light of those integrations?

Yes. I think the way I would think about the integration similar to the comment that Scott made about some of our payer contract wins, which is -- we have multiple integrations going on. I think Scott mentioned we're connecting over 4,000 different sites. And so some of those sites, we see immediate adoption and just because of the individual connections and others, yes, I would think when you think about larger health systems, this is going to continue through Q4 into Q1 of next year and throughout all of '25.

And your next question comes from Tycho Peterson from Jefferies. Please go ahead.

I'm not going to ask you about United. I'm curious about just some nuances around guidance. You lowered gross margin guidance 20 bps. You took the top end of the range down. Maybe just touch on that.

Yes, there's no change in the underlying fundamentals of the business. It's just there is some variability from product to product in terms of the gross margin profile, and that's just updating the blended average. But overall, the underlying gross margin profile remains just as healthy as before at the individual product level. .

Paul, I want to stress...

Yes, EPS went up, Tycho. I mean we are dropping through the growth.

Paul, I want to just stress kind of your comments around the Ambry deal because if they went through bankruptcy, semi exited reproductive health. I mean you did have some other factors there that accelerated share gains. It does seem like Ambry could be a different setup. Why would it be -- why would the share gain opportunity there to be similar, I guess, the other deals?

No, I think the Tempus situation is different, just like the (indiscernible) LabCorp situation is different. Each one of these are different. And the Tempus guys do a good job, just a question of when you go through these changes, whether it's (indiscernible) to LabCorp and some of the policy changes, we understand that are going to go in effect in January and people wait and see what the integration of Ambry does. You've got to harmonize products. You have to harmonize sales force. You have to harmonize rev cycle contracting, this is complicated work, and it always takes time, Tycho, what I've said and has experienced is you go through an integration, most customers, this is not on the top of their list. This is like number 30 of the things that a provider is worried about. But if they see changes and more importantly, if their frontline staff, their office workers, their nurses start seeing changes in service levels, turnaround times and start comparing products in terms of quality that just enables our sales force to go in and talk about the differentiation of our products and our experiences. So I can't -- I wouldn't call out any specifics, but I think all of these disruptions what we hear from genetic counters and others, begins to set us apart as a more reliable, trusted, stable provider that isn't going through the churn that we are seeing within (indiscernible).

And your next question comes from Dan Brennan from TD Cowen.

This is Kyle on for Dan. I'll just ask 1 here at non-Genesight related. Moving over to Hereditary Cancer, you talked about this category, I guess, as a whole growing volume sort of low-double-digit and stable pricing in the future. I think if we look at year-to-date, year-over-year and last 12 months on volume, volume sort of grown half this rate, call it, 6%, both year-to-date, year-over-year and last 12 months. Given these volume trends, how confident you that Hereditary Cancer can accelerate and grow at the corporate average next year? And I guess, what are the drivers?

Yes, I think I'll take that. I think what we try to do is sort of split out because when we think about what's baked into our Hereditary Cancer number, as we've mentioned, there is MyRisk on the affected and on the unaffected side. There's also the BRAC CDx component. And so I think what we've seen pulling down the overall average that you just talked about is some of that BRAC CDx business, not only domestically but also internationally, that is going to continue to be a lesser drag on the overall MyRisk growth that I think we're talking about. So we feel confident, and that's why we stated that we see the double-digit growth going into next year of total Hereditary because of the MyRisk adoption that we see. I think on the unaffected side, Paul referenced the breast cancer risk assessment that is a huge underpenetrated market, and we have a highly differentiated product there, and we're seeing growth there and we're integrating more risk assessment program, especially coming out of the October breast cancer risk awareness month. On the affected side, as we've mentioned, we are seeing double-digit growth there now. Now we have the Ambry dislocation. So there's just a lot of headroom for us here and there's been guidelines change, by the way, that have also recommended that any effective cancer patients should get a hereditary cancer test. So all of those things added, Paul?

Kyle, I'll just underscore 1 thing. And there's been a lot of change. We've talked about organizationally and our go-to-market and -- and we've clearly given up some volume for net revenue. And I mean -- so we have been much more careful about our targeting with sales force and trying to move the model from, you could have any hereditary cancer test for 249 to you can have the clinically differentiated MyRisk test with RiskScore but we need to work through your payer. We need to work you through prior auths and we've moved our whole sales force this year to a revenue-based model. The net effect has been, yes, we've cautiously given up a couple of percentage points of volume, but we're getting it back in space on the ASP. And so I think that's where the model needs to go for this industry, notwithstanding the fact that as we said throughout the year, we didn't expect to see the upswing of share shifts for hereditary cancer to even start until Q4 and accelerate next year. As I said, LabCorp and Adam those guys do a great job, but they're just starting to integrate some of their practices and policies, as I understand it from the field are just going to effect on January. So I would expect that the share shifts for hereditary, as we've said before, really going to be more of a '25 issue. The large accounts are just being onboarded now in Q4. Net-net to start moving ASP in hereditary and lower or no pay, which is like 36% for hereditary, that's a big number. So knocking that back -- that's why you've seen the bottom line improve here. And so it's profitable growth that we're focused on.

All right. And your next question comes from Michael Ryskin from Bank of America. Please go ahead.

This is John Kim on for Michael. I'll also skip ahead of GeneSight.

So we're certainly not at this point going to be projecting or committing to a 2025 improvement and just for everyone else on the call, I think what you're referencing is back at our investor event, we had referenced an improvement so far this year and no pay rate from 46% down to 44% and -- that is, as you can see from the robustness of the average revenue per test in our Q3 results that is a forward progress that we continue to see even into Q3. And so certainly, we are anticipating that would continue into Q4 as well. I had gotten the question at the investor event around what might be a reasonable target for annual benefit from continued no-pay improvement. And we talked -- and again, I'm not committing by any means to something for 2025 specifically. But we talked about certainly being able to achieve that 2% at a minimum that we've seen so far this year and a typical year. And certainly, in a good year, we could expect to do better than that potentially go for 4% as well.

And your next question comes from Mason Carrico from Stephens.

Hi, this is Nathan on for Mason. Thanks for taking the question today. I'm going to circle back to GeneSight here, but more from a strategic standpoint. I was hoping you'd be able to sort of lie out? There's obviously a profitability gap that you pointed to as a result of this decision here. So just kind of curious if you could give any color on sort of where the resources are going to be coming from to really address this decision with you and the additional interactions, touch points that you're going to have with the provider. And then just as a quick follow-up there. As you think about investing sort of across your business and you remain very committed to GeneSight, of course, and as well as your future offerings. So just kind of curious if you could help us think about investing across those different growth initiatives moving forward?

That's a really good question. Again, in terms of mitigation strategy, that's early, and you're right in terms of the underlying question, strategy is all about choices and where we make investment. What we tried to highlight at the Investor Day is having rationalized our portfolio, it positions us to try to invest in clinical evidence across all of our products. So that is a commitment to continue to look at all of our products and continue to position them to get to their full potential and GeneSight is included in that. And clearly, we need to continue to invest in building that body of clinical evidence to continue to support GeneSight coverage and adoption. There are opportunities, as we spoke to in women’s health, as we said, that are not in our 12% growth target. We've already made those investments in ForesightUniversal Plus. We have made investments in Prequel to move to 8 weeks gestational to have Amplify, make it the most accurate test and continue to do studies there. So if you go back to our Investor Day presentation, there was a lot of studies that Katie and the team, and Dale have advanced. There are more studies in the hopper. This is coming from a place where 4 years ago, quite frankly, the cover was pretty empty in terms of this. But certainly, the biggest area of opportunity to push this company into mid-teens growth rates is in oncology, and the work that Dr. Danekar is doing, our medical affairs group, the opportunities we have to pair MyRisk with Precise Tumor and in the Future Liquid and obviously, with a highly sensitive MRD assay that we think for certain indications is going to be incredibly important if people are thinking about deescalating care. But as our friends at United pointed out at this conference that we both attended recently, there's a lot of work that needs to be done in terms of the clinical utility around MRD and there's a long runway there. So I would just underscore for investors -- for long-term investors in Myriad Genetics. We have a lot of different levers to pull here and we are building a company for the next 10 years, not for the next 10 quarters. And whether it's the ASP opportunities that Scott pointed to our continued investment across the portfolio, they all give us different ways to achieve all the great work that Sam and the team is doing in live of the future, none of that has come into play yet. This year has been about multiple lab moves, multiple validations, and so our best days are really ahead of us, but it's a really good question, and we'll continue to look at investing capital wisely where the biggest returns are for our patients and for our investors.

There are no further questions at this time. I would like to turn the call back over to Matt Scalo for the closing remarks.

Okay. Thanks, Franz, and thanks, everyone, for your participation. This concludes our earnings call. A replay will be available via webcast on our website for one week. Thank you again for joining us this evening, and have a good night.