NASDAQ:MYGN Myriad Genetics Q3 2024 Earnings Report $7.64 -0.27 (-3.41%) Closing price 04:00 PM EasternExtended Trading$7.63 -0.01 (-0.13%) As of 04:20 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Myriad Genetics EPS ResultsActual EPS-$0.06Consensus EPS $0.02Beat/MissMissed by -$0.08One Year Ago EPS-$0.17Myriad Genetics Revenue ResultsActual Revenue$213.30 millionExpected Revenue$209.82 millionBeat/MissBeat by +$3.48 millionYoY Revenue GrowthN/AMyriad Genetics Announcement DetailsQuarterQ3 2024Date11/7/2024TimeAfter Market ClosesConference Call DateThursday, November 7, 2024Conference Call Time4:30PM ETUpcoming EarningsMyriad Genetics' Q1 2025 earnings is scheduled for Tuesday, May 6, 2025, with a conference call scheduled at 4:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)SEC FilingEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by Myriad Genetics Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 7, 2024 ShareLink copied to clipboard.There are 18 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Myriad Genetics Third Quarter 2024 Financial Earnings. I am Franz, and I'll be the operator assisting you today. All lines have been placed on mute to prevent any background noise. Operator00:00:16After the speakers' remarks, there will be a question and answer Thank you. And I would like to turn the call over to Matt Scalo. Please go ahead. Speaker 100:00:38Thank you, Franz, and good afternoon, and welcome to the Myriad Genetics' Q3 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 ks and can be found on our website at investor. Myriad.com. I'm Matt Skalo, Senior Vice President of Investor Relations. Speaker 100:01:04And on the call with me today are Paul Diaz, our President and Chief Executive Officer Scott Loeffler, our Chief Financial Officer Sam Rahad, our Chief Operating Officer and Mark Verratti, 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 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. Speaker 100:01:51We refer you to the documents the company files from time to time with the SEC, specifically the company's annual report on Form 10 ks, its quarterly reports on Form 10 Q and its current reports on Form 8 ks. 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 Speaker 200:02:16the call over to Paul. Speaker 300:02:18Thanks, Matt. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss the highlights from our strong Q3 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 tests 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. Speaker 300:03:06We continue to deliver on our commitment to shareholders as we achieved 11% revenue growth in the 3rd 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 $150,000,000 in gross profits, dollars 14,000,000 of adjusted EBITDA, positive adjusted EPS of $0.06 and maintain approximately $149,000,000 in liquidity in the Q3. 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 Firstgene, 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 Q3. Speaker 300:04:20With this positive momentum in mind 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 $840,000,000 and we are increasing our 2024 adjusted EPS target to between $0.12 $0.14 Last week UnitedHealthcare updated its medical policy restricting access to multi gene panel PTX 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 did not change their long held stance on this type of testing. GeneSight has a strong value proposition, which Mark Roddie will address further on today's call. Speaker 300:05:31And with approximately 3,000,000 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 in Optum to try to find a resolution to this policy change and hope for outcome in the next few months. GeneSight revenue associated with the United commercial business was approximately $40,000,000 for the twelve months period ending in Q3 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. Speaker 400:06:44Thanks, Paul. Speaker 500:06:45I would like to start with the product group. Myriad continues to lead the market with differentiated scientific insights offered by our myRisk withRiskScore 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 Q3, typical seasonal softness in July 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. Speaker 500:07:24While we continue to see 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 multistate health systems and we continue to expect to achieve double digit growth in hereditary cancer testing volumes with stable average revenue per test in 2025. Speaker 500:08:08Next slide. In the Q3, our women's health team delivered 10% prenatal revenue growth year over year and 24% for the trailing 12 month period, excluding Skin Speed. 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. Speaker 500:08:39In the Q3 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 Q3, 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. Speaker 500:09:25Far 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. Speaker 500:09:59We continue to see positive momentum with our PRECICE 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 Rahal. Thanks, Mark. Speaker 600:10:37As 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 costs 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. Speaker 600:11:21Over the last 3 years, we've invested over $75,000,000 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 Polaris as well as Precise MRD for clinical validation research projects. A 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 and started processing samples in Salt Lake City as of last week. Speaker 600:12:12We 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 with 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 increase internal efficiency and productivity. Speaker 600:12:53Our 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 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. Speaker 600:13:33We have system integrations across 15 more than 15 different vendors including strategic partnerships with EMR providers including Athena, EPIC, Flatiron for oncology and Lumeya for urology. As we look at the first half of twenty twenty five, we expect to add InoMed and LK EMR systems to enable for the first time healthcare providers and systems to be able to order the continuum of our oncology products from germline to somatic. Next slide. As we shared during our recent Investor Day, we see a meaningful opportunity for Myriad to serve community oncologists and healthcare 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 a 3rd foundational method patent from the USPTO, a personalized method for detecting circulating tumor DNA. Speaker 600:14:41In addition, our agreement with Personalis cross license patent estates cover tumor and form approaches to MRD fortifies our IP position. We plan to launch our first MRD commercial offering for breast cancer first half of twenty twenty six. Last month, we announced 5 ongoing research collaborations to 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 to 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 Doctor. Speaker 600:15:29Bora Lin at the University of Texas MD Anderson Cancer Center. Another study is to evaluate whether ctDNA levels correlate with nodal involvement in patients with newly diagnosed HR positive breast cancer and if so how the correspondence may be used to aid in surgical decision making led by Doctor. 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, dexatikan in HER2 positive advanced or metastatic breast cancer patients and whether ctDNA can be used to optimally guide therapy being led by Doctor. Yoichi Naoto of National Cancer Center Hospital East in Japan. Speaker 600:16:18Across 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 twenty twenty five and submitting data to Molodex in the second half of twenty twenty five 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 healthcare systems that count on us to serve their patients through the continuum of cancer care. Speaker 600:17:13I 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 years to increase 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 per customer service rep. Speaker 600:17:42Our 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 to 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 Loeffler. Speaker 200:18:12Thanks, 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, increase in our adjusted EBITDA to $14,100,000 and adjusted EPS improvement to $0.06 per share. While hereditary cancer testing revenues 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 2024, primarily impacting GeneSight. Speaker 200:18:51As 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 3 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. Speaker 200:19:38In 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 workflows and from our ongoing payer engagement activities. These include among other things, working with health plans to encourage their implementation of medical policies that conform to state biomarker legislation. As discussed on prior earnings calls, there's a growing list of states that have passed biomarker legislation that lends itself to ensuring access to precision medicine and advanced diagnostics. Speaker 200:20:26As we have mentioned, we recently received expanded commercial and managed Medicaid coverage for GeneSight with Blue Shield 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 7 contracts with new payers as we seek to bridge gaps in coverage across our no pay universe during the Q3. Those Q3 results bring us to 18 new contracts and 29 new coverage wins on a year to date basis. As I have said in the past, no one of these wins will generally meaningfully move the revenue needle, but we certainly expect the accumulation of many small and medium sized wins over time to contribute to the maturing and more stable rate environment for our products. Speaker 200:21:24Next slide. As a reminder, we closed the sale of our European EndoPredict business during the Q3. There was a one time 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 $11,000,000 of annual run rate revenue. Importantly, it will be accretive by more than $4,000,000 per year to our go forward adjusted operating income by streamlining our cost structure. Speaker 200:21:54We 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 to 11% year over year growth in gross profit dollars. Speaker 200:22:25On a year to date basis, we've generated 14% growth in gross profit dollars. Our adjusted EBITDA for the quarter was $14,000,000 and is now $48,000,000 on a trailing 12 month basis as of Q3. The combination of our generous gross profit base and increasing levels of adjusted EBITDA of adjusted EBITDA profitability demonstrate the profit and cash generating potential of the business, especially as we generate more operating leverage over our operating expenses. We also finished Q3 in a strong liquidity position with $149,000,000 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. Speaker 200:23:19Next 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 $820,000,000 to $840,000,000 On our last earnings call, we updated that range to $835,000,000 to $845,000,000 In light of our Q3 performance and continued execution, we are narrowing our full year revenue range to $837,000,000 to $843,000,000 Our updated gross margin expectation is 69.8% to 70.3% and our OpEx is now expected to be $565,000,000 to $570,000,000 The net impact of these updates is a more favorable bottom line performance with adjusted EBITDA of $34,000,000 to $39,000,000 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. Speaker 300:24:33Thanks, Scott. We continue to build on the pillars of long term growth and profitability that delivered our strong results in the Q3. 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 $40,000,000 in the most recent 12 month period. Speaker 300:25:07If the policy change goes into effect in January, we would expect a loss of about $40,000,000 of revenue. That would translate to approximately $30,000,000 of lost gross profits. Our preliminary view is that we can mitigate at least $10,000,000 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 budgeted 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. Speaker 300:25:53Our modernized labs and commercial engines are examples of where investments in automation and advanced technology are yielding improved workflows, faster turnaround times and reduced 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 and A. Thanks, Paul. Speaker 300:26:35And as Speaker 100:26:35a 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 and A session. To ensure broad participation, we're asking participants to please ask only one question and one follow-up. France, we are now ready for the Q and A portion of the call. Operator00:27:04Thank you. And we will now begin the question and answer And your first question comes from the line of Doug Schenkel from Wolfe Research. Please go ahead. Speaker 700:27:49Good afternoon, guys. Thanks for taking my questions. 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. Speaker 700:28:11Presumably 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 why don't I pause there and then I'll come back with a follow-up on the philosophical question. Speaker 300:28:37Yes. So Doug, try to be real clear about the math. So of our $840,000,000 of revenue that we expect this year, approximately $40,000,000 of it is United Commercial. And we expect to be able to grow in double digits on that sort of pro form a base. We are still aiming for a 12% growth rate next year and beyond. Speaker 300:29:05We'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 failed to take into account and quite 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. Speaker 300:29:35And quite frankly, it's 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 in some to some extent from other polygenic from other PGx tests. So that's the math that I would anchor you on. Speaker 300:30:11And we again, I wanted to give you a sense of the gross profits there of around $30,000,000 and that we've already started putting our arms around at least $10,000,000 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. Speaker 700:30:37No, 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 Asurex 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 and even the clinical community. Speaker 700:31:11The 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 stop the lawsuits. You're really good with disclosure. You haven't been adversarial with payers. Speaker 700:31:38You'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. Again, I think to a certain extent the clinical community. What's the criteria you decide you use to decide if any asset keeping GeneSight very much in mind should be part of Myriad 2.0, should be part of your business? Speaker 700:32:15Thank you. Speaker 300:32:17Yes. Thanks, Doug. Well, first of all, let's underscore a big we here. The last four and a half years have 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. Speaker 300:32:41We have divested those non strategic 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, 3,000,000 patients out there, including a number of personal stories that I can get into offline 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. Speaker 300:33:36And so, we're looking forward to sharing more of that data and 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. Operator00:34:09And your next question comes from Tejas Sazan from Morgan Stanley. Please go ahead. Speaker 800:34:17Hi. This is Madison on for Tejas. Thanks for taking the question. 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 Speaker 900:34:29relatively less mature than, say, for like oncology, do you think Speaker 800:34:30that there is a risk that 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? Speaker 300:34:48Well, I think that we acknowledge that the payers, it's their turn in the cycle here. And they're facing on their 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. Speaker 300:35:29But there's no question that their pressure gets extended like everybody else in the healthcare 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 in their 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. Speaker 300:36:19But we think in the context and I have a fair amount of experience in this in turn 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 drug faster and improve their overall treatment process. Speaker 800:36:43Got it. Okay. That makes sense. 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's decision. Speaker 800:36:56And then more specifically, what had your revised long term targets assumed by way of improvement in the GeneSight no pay rate over the next couple of years? Speaker 300:37:11Well, 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 as a lot of ground game, 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. Speaker 300:37:42And it takes months if not a year to make it into medical policy and then make it into contract. 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 pays for GeneSight and quite frankly continue to grow GeneSight. Speaker 300:38:16And 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 form a 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 and L that you really saw this quarter and the drop through that is happening across our P and L. Speaker 800:38:56Got it. Okay, very helpful. Thanks for the time guys. Speaker 300:39:00Thank you. Operator00:39:03And your next question comes from Suneet Souda from Leerink Partners. Please go ahead. Speaker 1000:39:10Yes. Hi, Paul. So just wanted to clarify on gene side. 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. Speaker 1000:39:30So 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 MA 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? Speaker 300:39:53Yes, let me start with the last one Puneet. Thank you. As I said a few minutes ago, the whole healthcare 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 pays 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 BRAC in terms of hereditary cancer, for example. Speaker 300:40:31So, I think there's more than enough upside to improving our ASP, notwithstanding the global pressures. And we're not seeing and we 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. Speaker 300:41:16We 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 note pace. Speaker 1000:41:30Got 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? Speaker 1000:41:45You obviously taken 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? Speaker 300:42:02Yes. 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 Vitae, Semaphore and now the transaction of Ambre all create opportunities for us to gain share as a respected and quite frankly the leading provider for hereditary cancer tests. Speaker 300:42:31This 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 VITA 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. Speaker 300:43:19So we're quite bullish on our opportunity to grow myRisk, our hereditary cancer tests across all of our channels in 2025. Mark? Speaker 500:43:29Yes. The only thing I would add to that, just to echo Paul's comments, on the unaffected side are on 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. Speaker 500:43:54So 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 move from one competitor to another, doesn't happen overnight, but it really does open up a lot of opportunities for Mira to be back in there, selling the best in class test. Speaker 500:44:22And 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. Speaker 300:44:32There's a warm room already stood up on Invitae and Ambre, I promise you. Speaker 1000:44:38All right. Thanks, Paul. I'll leave it at that. Operator00:44:46And your next question comes from Chant Kota from Goldman Sachs. Please go ahead. Speaker 900:44:53Hey, 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 timeline of further dilution of no pay rate from the addition of new products? Speaker 900:45:10For 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 I wanted to ask that first. Speaker 300:45:26Yes, 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. Speaker 300:46:09In fact, our discussions with United around MRD are right around this topic that we will 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 first gene. Speaker 300:46:39You will see that with 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 Speaker 600:46:59you said that very well, Paul. Yes. Speaker 900:47:02Got it. Thank you. That's helpful. And then just playing devil's advocate, what if 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? Speaker 300:47:23Yes. 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 1st gene 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. Speaker 300:47:55Those products we hope and expect as we think about 2026 and 2027 start pointing us to growth in the mid teens. And again with many different levers to maintain our 70% gross margins. Speaker 1100:48:10Thank you. Operator00:48:25And your next question comes from Subbu Nambi from Guggenheim Partners. Please go ahead. Speaker 400:48:32Hey guys, thank you for taking my question. Clearly, the UnitedHealth decision was a surprise. One of the things that made it all the most surprising is that a United 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? Speaker 300:49:02Well, I think United is a big complex organization and that's been incredibly successful, one of the more successful healthcare companies in America. But it is quite a big complex organization and not really sure if they took that health economics data into account, but I assure you when we sit down with them in the next couple of weeks that 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. Speaker 300:49:49And again, part of what I think we're going to discuss with United is the difference between GeneSight and some of the other PGx tests out in the marketplace and that differentiation both in terms of clinical utility and clinical validity. So we can't tell you exactly what ended it. 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 give them a rise to this policy change. Speaker 300:50:33So we're really scratching our heads about this, but we'll know more in the weeks to come once we sit down with them. Speaker 400:50:41Thank you for that, Paul. And just to address the elephant in the room, what gives you the confidence that other payers won't pay won't pull their coverage for GeneSight, especially payers are always looking for an excuse to not pay for tests, especially diagnostic tests. So just anything, any sign I know you said about the personal stories and the data that's out there, but these were all out there even when United took that decision. So just trying to see how are you planning to mitigate that? Speaker 300:51:13We'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 a clinical evidence across all our products. Speaker 300:51:37And 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 tests as 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. Speaker 300:52:29And 4 days in that's the best we can tell you. Speaker 400:52:33Thank you. Thank you for that, Paul. Speaker 300:52:35Sure. No, thank you. Operator00:52:41Okay. And your next question comes from Sung Ji Nam from Scotiabank. Please go ahead. Speaker 1200:52:50Paul, 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 endpoints or metrics or size of patient cohorts they're looking for? Just trying to better understand kind of what's missing from their perspective. Speaker 300:53:13We'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 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'll 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. Speaker 300:54:05So 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 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. Speaker 300:54:36I 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. Speaker 1200:54:48Got you. And then just curious on that note, trying to assess the best case scenario, worst case scenario, maybe the worst case scenario is more obvious. But best case scenario, do you think something like this after presenting additional data, something like this 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 UnitedHealth portion of your GeneSight business has been growing at kind of roughly the same rate as the rest of the business? Speaker 1200:55:25Or has it been growing faster over the last few years? Thank you. Speaker 300:55:30Sure. Mark, do you want to take the last one and then I'll take it for him? Speaker 500:55:32Yes. 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 volume versus the no pay reductions that we've talked about earlier. Speaker 300:55:49With respect to our hope that United might modify this most recent policy, we can't speak to the timeframes around that. But we do think that there is enough here for them to revisit the policy, potentially suspend 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. Speaker 300:56:36We'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 form a 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 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 form a base and we'll go from there. Speaker 1200:57:18Great. Thank you so Speaker 1300:57:23much. Operator00:57:25Okay. 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 Watsendahl from JPMorgan. Please go ahead. Speaker 800:57:41Great. Thanks so much for taking the question. Hi, guys. Speaker 1400:57:45So I wanted to dig in a little bit more on GeneSight again. Specifically just on the actual market size for pharmacogenomics. So your Analyst Day a few weeks ago, you talked about how the market size was $2,000,000,000 You said that was based on the most updated data that you had at the time. If we look at the year before, you guys had really pointed us towards that $5,000,000,000 actionable market. I know you talked about how some of the underlying data you're just working with with the best you had at the time, but can you break down for us what really changed in that underlying market data? Speaker 1400:58:14And then 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 $2,000,000,000 TAM that you provided a few weeks ago? Speaker 300:58:29I'm sorry. We will sit down with you and Ramya, who is 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. Speaker 300:59:04Tough sledding 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 of 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. Speaker 300:59:42And 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 and across the MLRs of payers, it's a problem. It's an issue. So whether TAM is $3,000,000,000 or $5,000,000,000 we'll 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. Speaker 301:00:22And we think there's a real long term opportunity for us and for our patients here at Miragenetics in this regard. Speaker 1401:00:32Fair 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 at 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? Speaker 501:00:53Yes. 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. Speaker 501:01:14And 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 in V Day 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. 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. Speaker 301:01:54Yes. Look, I'm going to just actually get yes, I mean, the opportunity in prenatal for prequel, for example, or an IPS test that we're going to be launching at 8 weeks, the stational, 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. Speaker 301:02:42Moving to average risk has moved has listed all the boats in terms of prenatal testing. And that's even before we get the carrier screening and a potential ACOG guideline expansion and our pre launch of Foresight Universal Plus. So in the prenatal space, it's narrowed to 3, 4, 5 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 there though, as Mark pointed out, is the ability to bring myRisk with riskScore and our newly recently launched breast cancer risk assessment program into that channel. Speaker 301:03:30And so I will tell you that one of the things that we're most excited about not only is the prenatal and women's health, but doing more particularly with breast density being an issue and FDA guidelines expansion, bringing more of our myRisk tests with risk score that is not available for anybody else for patients of all ancestry into that women's health channel. Lots of opportunity in green space for us there. Operator01:04:04And your next question comes from Brandon Couillard from Wells Fargo. Please go ahead. Speaker 1301:04:11Hey, Sachin. I have a couple of questions for you. Just for the firm, the current impact, you alluded to volumes coming back pretty strong in the last few weeks. Just wanted to make sure there's no hurricane effect. And is the prior period revenue benefit in the 3rd quarter, is that $7,000,000 I think that's about what it was last year? Speaker 1301:04:29Thanks. Speaker 201:04:32Hey, Brandon, 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's. Last year's was around $7,000,000 This year it was a little over $8,000,000 If you could repeat the first part of your question. Speaker 1301:04:55Yeah. I was asking if just the implied Q4 guide embeds any headwind from the hurricane disruption. I think Paul talked about volumes coming back strong in the last few weeks, but wanted to make sure there's Speaker 1501:05:10that's the case. Speaker 201:05:12Yes. I think we're pleased to see a normalization in volumes, but and so no, the Q4 guide doesn't assume any kind of particular weather related headwind coming out of. Speaker 1301:05:26Okay. Last question, you've got it looks like a number of EMR site integrations planned for the Q4. 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 Q1 perhaps having less of a step down, less seasonality in light of those integrations? Thanks. Speaker 501:05:51Yes. 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 2025. Operator01:06:30And your next question comes from Tycho Peterson from Jefferies. Please go ahead. Speaker 1601:06:37Hey, thanks. 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. Speaker 1601:06:46Maybe just touch on that. Speaker 201:06:50Yes. 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 as the individual product level. Operator01:07:08Okay. Speaker 1601:07:09Paul, I want to stress test and kind of Okay. Speaker 301:07:12EPS went up, Tycho. I mean, we are dropping through the growth. Speaker 1601:07:18Paul, I want to just stress test kind of your comments around the Ambre deal because Invitae went through bankruptcy, Semaphore 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 be similar, I guess, to the other deal? Speaker 301:07:40No, I think the SemaForce situation is different just like the Invitae LabCorp situation is different. Each one of these are different. And the Tempest guys do a good job. Just a question of when you go through these changes, whether it's Invitae to LabCorp and some of the policy changes we understand are going to go into effect in January. And people wait and see what the integration of Ambury does. Speaker 301:08:09You 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 have 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. Speaker 301:08:33But if they see changes and more importantly if their frontline staff, their office workers, their nurses start seeing changes in service level, 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 counselors and others, it gets to set us apart as a more reliable, trusted, stable provider that isn't going through the churn that we are seeing within Invitae, Ambre and Semaphore. Operator01:09:20Okay. Thank you. Sure. And your next question comes from Dan Brennan from TD Cowen. Please go ahead. Speaker 1501:09:36Hey, good afternoon, guys. This is Kyle on for Dan. Thanks for taking the questions. I'll just ask one here, 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. Speaker 1501:09:51I think if we look at year to date, year over year in last 12 months on volume, volume sort of grown half this rate, call it 6%, both year to date year over year in last 12 months. Given these volume trends, how confident are you that hereditary cancer can accelerate and grow at the corporate average next year? And I guess what are the drivers? Speaker 501:10:10Yes, 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 my risk 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. Speaker 501:10:37So 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 There's a huge underpenetrated market. And we have a highly differentiated product there and we're seeing growth there and we're integrating more breast risk assessment programs, 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 AMBERY dislocation. Speaker 501:11:15So there's just a lot of headroom for us here. And there's been guidelines changed 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, you want to add? Speaker 301:11:30Kyle, I'll just underscore one thing and there's been a lot of change. We've talked about organizationally in our go to market 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 Salesforce and trying to move the model from you can have any hereditary cancer test for 249 to you can have the clinically differentiated myRisk test with risk more, but we need to work through your payer. We need to work through prior auth and we've moved our whole sales force this year to a revenue based model. The net effect has been, yes, we've consciously given up a couple of percentage points of volume, but we're getting it back in spades on the ASP. Speaker 301:12:29And 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 are as we've said before really going to be more of a 25 issue. Speaker 301:13:11The 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. Speaker 1501:13:37Got it. Thanks, guys. Operator01:13:42All right. And your next question comes from Michael Reissen from Bank of America. Please go ahead. Speaker 1101:13:51Hello. This is John Kim on for Michael. I'll also skip ahead of GeneSight. You mentioned Speaker 301:14:01We can talk about GeneSight. No need to apologize. It's okay. Speaker 1101:14:04You guys have talked extensively about it. And yes, I understand the uncertainty, but yes, you guys are doing everything you can. But and it's great to hear that. But you mentioned the 2% reduction in no pay rate from your RCM effort. Could you size what sort of progress has been made versus what sort of opportunity remains? Speaker 1101:14:30And how much of that could you quantify how much of that we can see we might see in 2025? Speaker 201:14:38So 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 percent 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. Speaker 201:15:23And 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 3% or 4% as well. Speaker 1101:15:45Got it. I'll keep it to 1. Thank you. Operator01:15:58And your next question comes from Mason Carriko from Stephens. Please go ahead. Speaker 1701:16:06Hi, 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 UNH, the additional interactions touch points that you're going to have with the provider. Speaker 1701:16:44And 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? Speaker 301:17:04That'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 try 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. Speaker 301:17:37And 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 Foresight Universal 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. Speaker 301:18:15So 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 that 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 Doctor. Speaker 301:18:43Daneker 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 de escalating care. But as our friends at United pointed out at this conference that we both attended here 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 Miragenetics, 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 or 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 lab of the future. None of that has come into play yet. Speaker 301:19:52This year has been about multiple lab moves, multiple validation. 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. Speaker 1701:20:11Thank you. I'll keep it to 1. Appreciate the update today. Speaker 301:20:17No, thank you. Operator01:20:26There are no further questions at this time. I would like to turn the call back over to Matt Kallo for the closing remarks. Please go ahead. Speaker 501:20:36Okay. Speaker 101:20:37Thanks, France, and thanks, everyone, for your participation. This concludes our earnings call. A replay will be available via webcast on our website for 1 week. Thank you again for joining us this evening and have a good night. Speaker 301:20:50Thanks everybody. Thank you.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallMyriad Genetics Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) Myriad Genetics Earnings HeadlinesDemystifying Myriad Genetics: Insights From 10 Analyst ReviewsApril 17 at 8:19 PM | benzinga.comMyriad Genetics price target lowered to $9 from $11 at BofAApril 15 at 10:12 AM | finance.yahoo.comTrump Treasure April 19Thanks to President Trump… A $900 investment across5 specific cryptos… Could gain 12,000% so quickly that, just 12 months later…April 17, 2025 | Paradigm Press (Ad)Myriad Genetics price target lowered to $9 from $11 at BofAApril 15 at 3:12 AM | markets.businessinsider.comMyriad Genetics (MYGN) Sees Price Target Lowered by BofA Amid Policy Concerns | MYGN Stock NewsApril 14 at 11:12 AM | gurufocus.comMyriad Genetics (NASDAQ:MYGN) Cut to "Neutral" at GuggenheimApril 12, 2025 | americanbankingnews.comSee More Myriad Genetics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Myriad Genetics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Myriad Genetics and other key companies, straight to your email. Email Address About Myriad GeneticsMyriad Genetics (NASDAQ:MYGN), a genetic testing and precision medicine company, develops genetic tests in the United States and internationally. The company offers molecular diagnostic tests for use in oncology, and women's and pharmacogenomics. It also provides MyRisk Hereditary Cancer Test, a DNA sequencing test for assessing the risks for hereditary cancers; BRACAnalysis CDx Germline Companion Diagnostic Test, a DNA sequencing test to help determine the therapy for patients with metastatic breast, ovarian, metastatic pancreatic, and metastatic prostate cancer with deleterious or suspected deleterious germline BRCA variants; and MyChoice CDx Companion Diagnostic Test, a tumor test that determines homologous recombination deficiency status in patients with ovarian cancer. The company also offers Prolaris Prostate Cancer Prognostic Test, an RNA expression tumor analysis for assessing the aggressiveness of prostate cancer; EndoPredict Breast Cancer Prognostic Test, an RNA expression test for assessing the aggressiveness of breast cancer; Precise Tumor, a solution for precision oncology; and Prequel Prenatal Screen, a non-invasive prenatal screening test conducted using maternal blood to screen for severe chromosomal disorders in a fetus. It provides Foresight Carrier Screen, a prenatal test for future parents to assess their risk of passing on a recessive genetic condition to their offspring; SneakPeek, a non-invasive blood test that predicts the gender of a fetus; and GeneSight Psychotropic Mental Health Medication Test, a DNA genotyping test to aid psychotropic drug selection for patients suffering from depression, anxiety, attention-deficit, hyperactivity disorder, and other mental health conditions. It has a strategic collaboration with Illumina, Inc., Memorial Sloan Kettering Cancer Center, the University of Texas MD Anderson Cancer Center, SimonMed, and Onsite Women's Health. Myriad Genetics, Inc. was incorporated in 1992 and is headquartered in Salt Lake City, Utah.View Myriad Genetics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles 3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 18 speakers on the call. Operator00:00:00Good afternoon, and welcome to the Myriad Genetics Third Quarter 2024 Financial Earnings. I am Franz, and I'll be the operator assisting you today. All lines have been placed on mute to prevent any background noise. Operator00:00:16After the speakers' remarks, there will be a question and answer Thank you. And I would like to turn the call over to Matt Scalo. Please go ahead. Speaker 100:00:38Thank you, Franz, and good afternoon, and welcome to the Myriad Genetics' Q3 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 ks and can be found on our website at investor. Myriad.com. I'm Matt Skalo, Senior Vice President of Investor Relations. Speaker 100:01:04And on the call with me today are Paul Diaz, our President and Chief Executive Officer Scott Loeffler, our Chief Financial Officer Sam Rahad, our Chief Operating Officer and Mark Verratti, 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 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. Speaker 100:01:51We refer you to the documents the company files from time to time with the SEC, specifically the company's annual report on Form 10 ks, its quarterly reports on Form 10 Q and its current reports on Form 8 ks. 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 Speaker 200:02:16the call over to Paul. Speaker 300:02:18Thanks, Matt. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss the highlights from our strong Q3 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 tests 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. Speaker 300:03:06We continue to deliver on our commitment to shareholders as we achieved 11% revenue growth in the 3rd 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 $150,000,000 in gross profits, dollars 14,000,000 of adjusted EBITDA, positive adjusted EPS of $0.06 and maintain approximately $149,000,000 in liquidity in the Q3. 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 Firstgene, 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 Q3. Speaker 300:04:20With this positive momentum in mind 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 $840,000,000 and we are increasing our 2024 adjusted EPS target to between $0.12 $0.14 Last week UnitedHealthcare updated its medical policy restricting access to multi gene panel PTX 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 did not change their long held stance on this type of testing. GeneSight has a strong value proposition, which Mark Roddie will address further on today's call. Speaker 300:05:31And with approximately 3,000,000 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 in Optum to try to find a resolution to this policy change and hope for outcome in the next few months. GeneSight revenue associated with the United commercial business was approximately $40,000,000 for the twelve months period ending in Q3 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. Speaker 400:06:44Thanks, Paul. Speaker 500:06:45I would like to start with the product group. Myriad continues to lead the market with differentiated scientific insights offered by our myRisk withRiskScore 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 Q3, typical seasonal softness in July 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. Speaker 500:07:24While we continue to see 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 multistate health systems and we continue to expect to achieve double digit growth in hereditary cancer testing volumes with stable average revenue per test in 2025. Speaker 500:08:08Next slide. In the Q3, our women's health team delivered 10% prenatal revenue growth year over year and 24% for the trailing 12 month period, excluding Skin Speed. 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. Speaker 500:08:39In the Q3 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 Q3, 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. Speaker 500:09:25Far 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. Speaker 500:09:59We continue to see positive momentum with our PRECICE 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 Rahal. Thanks, Mark. Speaker 600:10:37As 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 costs 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. Speaker 600:11:21Over the last 3 years, we've invested over $75,000,000 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 Polaris as well as Precise MRD for clinical validation research projects. A 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 and started processing samples in Salt Lake City as of last week. Speaker 600:12:12We 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 with 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 increase internal efficiency and productivity. Speaker 600:12:53Our 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 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. Speaker 600:13:33We have system integrations across 15 more than 15 different vendors including strategic partnerships with EMR providers including Athena, EPIC, Flatiron for oncology and Lumeya for urology. As we look at the first half of twenty twenty five, we expect to add InoMed and LK EMR systems to enable for the first time healthcare providers and systems to be able to order the continuum of our oncology products from germline to somatic. Next slide. As we shared during our recent Investor Day, we see a meaningful opportunity for Myriad to serve community oncologists and healthcare 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 a 3rd foundational method patent from the USPTO, a personalized method for detecting circulating tumor DNA. Speaker 600:14:41In addition, our agreement with Personalis cross license patent estates cover tumor and form approaches to MRD fortifies our IP position. We plan to launch our first MRD commercial offering for breast cancer first half of twenty twenty six. Last month, we announced 5 ongoing research collaborations to 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 to 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 Doctor. Speaker 600:15:29Bora Lin at the University of Texas MD Anderson Cancer Center. Another study is to evaluate whether ctDNA levels correlate with nodal involvement in patients with newly diagnosed HR positive breast cancer and if so how the correspondence may be used to aid in surgical decision making led by Doctor. 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, dexatikan in HER2 positive advanced or metastatic breast cancer patients and whether ctDNA can be used to optimally guide therapy being led by Doctor. Yoichi Naoto of National Cancer Center Hospital East in Japan. Speaker 600:16:18Across 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 twenty twenty five and submitting data to Molodex in the second half of twenty twenty five 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 healthcare systems that count on us to serve their patients through the continuum of cancer care. Speaker 600:17:13I 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 years to increase 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 per customer service rep. Speaker 600:17:42Our 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 to 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 Loeffler. Speaker 200:18:12Thanks, 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, increase in our adjusted EBITDA to $14,100,000 and adjusted EPS improvement to $0.06 per share. While hereditary cancer testing revenues 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 2024, primarily impacting GeneSight. Speaker 200:18:51As 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 3 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. Speaker 200:19:38In 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 workflows and from our ongoing payer engagement activities. These include among other things, working with health plans to encourage their implementation of medical policies that conform to state biomarker legislation. As discussed on prior earnings calls, there's a growing list of states that have passed biomarker legislation that lends itself to ensuring access to precision medicine and advanced diagnostics. Speaker 200:20:26As we have mentioned, we recently received expanded commercial and managed Medicaid coverage for GeneSight with Blue Shield 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 7 contracts with new payers as we seek to bridge gaps in coverage across our no pay universe during the Q3. Those Q3 results bring us to 18 new contracts and 29 new coverage wins on a year to date basis. As I have said in the past, no one of these wins will generally meaningfully move the revenue needle, but we certainly expect the accumulation of many small and medium sized wins over time to contribute to the maturing and more stable rate environment for our products. Speaker 200:21:24Next slide. As a reminder, we closed the sale of our European EndoPredict business during the Q3. There was a one time 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 $11,000,000 of annual run rate revenue. Importantly, it will be accretive by more than $4,000,000 per year to our go forward adjusted operating income by streamlining our cost structure. Speaker 200:21:54We 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 to 11% year over year growth in gross profit dollars. Speaker 200:22:25On a year to date basis, we've generated 14% growth in gross profit dollars. Our adjusted EBITDA for the quarter was $14,000,000 and is now $48,000,000 on a trailing 12 month basis as of Q3. The combination of our generous gross profit base and increasing levels of adjusted EBITDA of adjusted EBITDA profitability demonstrate the profit and cash generating potential of the business, especially as we generate more operating leverage over our operating expenses. We also finished Q3 in a strong liquidity position with $149,000,000 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. Speaker 200:23:19Next 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 $820,000,000 to $840,000,000 On our last earnings call, we updated that range to $835,000,000 to $845,000,000 In light of our Q3 performance and continued execution, we are narrowing our full year revenue range to $837,000,000 to $843,000,000 Our updated gross margin expectation is 69.8% to 70.3% and our OpEx is now expected to be $565,000,000 to $570,000,000 The net impact of these updates is a more favorable bottom line performance with adjusted EBITDA of $34,000,000 to $39,000,000 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. Speaker 300:24:33Thanks, Scott. We continue to build on the pillars of long term growth and profitability that delivered our strong results in the Q3. 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 $40,000,000 in the most recent 12 month period. Speaker 300:25:07If the policy change goes into effect in January, we would expect a loss of about $40,000,000 of revenue. That would translate to approximately $30,000,000 of lost gross profits. Our preliminary view is that we can mitigate at least $10,000,000 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 budgeted 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. Speaker 300:25:53Our modernized labs and commercial engines are examples of where investments in automation and advanced technology are yielding improved workflows, faster turnaround times and reduced 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 and A. Thanks, Paul. Speaker 300:26:35And as Speaker 100:26:35a 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 and A session. To ensure broad participation, we're asking participants to please ask only one question and one follow-up. France, we are now ready for the Q and A portion of the call. Operator00:27:04Thank you. And we will now begin the question and answer And your first question comes from the line of Doug Schenkel from Wolfe Research. Please go ahead. Speaker 700:27:49Good afternoon, guys. Thanks for taking my questions. 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. Speaker 700:28:11Presumably 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 why don't I pause there and then I'll come back with a follow-up on the philosophical question. Speaker 300:28:37Yes. So Doug, try to be real clear about the math. So of our $840,000,000 of revenue that we expect this year, approximately $40,000,000 of it is United Commercial. And we expect to be able to grow in double digits on that sort of pro form a base. We are still aiming for a 12% growth rate next year and beyond. Speaker 300:29:05We'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 failed to take into account and quite 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. Speaker 300:29:35And quite frankly, it's 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 in some to some extent from other polygenic from other PGx tests. So that's the math that I would anchor you on. Speaker 300:30:11And we again, I wanted to give you a sense of the gross profits there of around $30,000,000 and that we've already started putting our arms around at least $10,000,000 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. Speaker 700:30:37No, 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 Asurex 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 and even the clinical community. Speaker 700:31:11The 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 stop the lawsuits. You're really good with disclosure. You haven't been adversarial with payers. Speaker 700:31:38You'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. Again, I think to a certain extent the clinical community. What's the criteria you decide you use to decide if any asset keeping GeneSight very much in mind should be part of Myriad 2.0, should be part of your business? Speaker 700:32:15Thank you. Speaker 300:32:17Yes. Thanks, Doug. Well, first of all, let's underscore a big we here. The last four and a half years have 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. Speaker 300:32:41We have divested those non strategic 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, 3,000,000 patients out there, including a number of personal stories that I can get into offline 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. Speaker 300:33:36And so, we're looking forward to sharing more of that data and 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. Operator00:34:09And your next question comes from Tejas Sazan from Morgan Stanley. Please go ahead. Speaker 800:34:17Hi. This is Madison on for Tejas. Thanks for taking the question. 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 Speaker 900:34:29relatively less mature than, say, for like oncology, do you think Speaker 800:34:30that there is a risk that 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? Speaker 300:34:48Well, I think that we acknowledge that the payers, it's their turn in the cycle here. And they're facing on their 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. Speaker 300:35:29But there's no question that their pressure gets extended like everybody else in the healthcare 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 in their 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. Speaker 300:36:19But we think in the context and I have a fair amount of experience in this in turn 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 drug faster and improve their overall treatment process. Speaker 800:36:43Got it. Okay. That makes sense. 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's decision. Speaker 800:36:56And then more specifically, what had your revised long term targets assumed by way of improvement in the GeneSight no pay rate over the next couple of years? Speaker 300:37:11Well, 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 as a lot of ground game, 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. Speaker 300:37:42And it takes months if not a year to make it into medical policy and then make it into contract. 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 pays for GeneSight and quite frankly continue to grow GeneSight. Speaker 300:38:16And 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 form a 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 and L that you really saw this quarter and the drop through that is happening across our P and L. Speaker 800:38:56Got it. Okay, very helpful. Thanks for the time guys. Speaker 300:39:00Thank you. Operator00:39:03And your next question comes from Suneet Souda from Leerink Partners. Please go ahead. Speaker 1000:39:10Yes. Hi, Paul. So just wanted to clarify on gene side. 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. Speaker 1000:39:30So 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 MA 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? Speaker 300:39:53Yes, let me start with the last one Puneet. Thank you. As I said a few minutes ago, the whole healthcare 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 pays 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 BRAC in terms of hereditary cancer, for example. Speaker 300:40:31So, I think there's more than enough upside to improving our ASP, notwithstanding the global pressures. And we're not seeing and we 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. Speaker 300:41:16We 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 note pace. Speaker 1000:41:30Got 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? Speaker 1000:41:45You obviously taken 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? Speaker 300:42:02Yes. 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 Vitae, Semaphore and now the transaction of Ambre all create opportunities for us to gain share as a respected and quite frankly the leading provider for hereditary cancer tests. Speaker 300:42:31This 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 VITA 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. Speaker 300:43:19So we're quite bullish on our opportunity to grow myRisk, our hereditary cancer tests across all of our channels in 2025. Mark? Speaker 500:43:29Yes. The only thing I would add to that, just to echo Paul's comments, on the unaffected side are on 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. Speaker 500:43:54So 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 move from one competitor to another, doesn't happen overnight, but it really does open up a lot of opportunities for Mira to be back in there, selling the best in class test. Speaker 500:44:22And 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. Speaker 300:44:32There's a warm room already stood up on Invitae and Ambre, I promise you. Speaker 1000:44:38All right. Thanks, Paul. I'll leave it at that. Operator00:44:46And your next question comes from Chant Kota from Goldman Sachs. Please go ahead. Speaker 900:44:53Hey, 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 timeline of further dilution of no pay rate from the addition of new products? Speaker 900:45:10For 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 I wanted to ask that first. Speaker 300:45:26Yes, 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. Speaker 300:46:09In fact, our discussions with United around MRD are right around this topic that we will 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 first gene. Speaker 300:46:39You will see that with 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 Speaker 600:46:59you said that very well, Paul. Yes. Speaker 900:47:02Got it. Thank you. That's helpful. And then just playing devil's advocate, what if 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? Speaker 300:47:23Yes. 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 1st gene 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. Speaker 300:47:55Those products we hope and expect as we think about 2026 and 2027 start pointing us to growth in the mid teens. And again with many different levers to maintain our 70% gross margins. Speaker 1100:48:10Thank you. Operator00:48:25And your next question comes from Subbu Nambi from Guggenheim Partners. Please go ahead. Speaker 400:48:32Hey guys, thank you for taking my question. Clearly, the UnitedHealth decision was a surprise. One of the things that made it all the most surprising is that a United 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? Speaker 300:49:02Well, I think United is a big complex organization and that's been incredibly successful, one of the more successful healthcare companies in America. But it is quite a big complex organization and not really sure if they took that health economics data into account, but I assure you when we sit down with them in the next couple of weeks that 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. Speaker 300:49:49And again, part of what I think we're going to discuss with United is the difference between GeneSight and some of the other PGx tests out in the marketplace and that differentiation both in terms of clinical utility and clinical validity. So we can't tell you exactly what ended it. 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 give them a rise to this policy change. Speaker 300:50:33So we're really scratching our heads about this, but we'll know more in the weeks to come once we sit down with them. Speaker 400:50:41Thank you for that, Paul. And just to address the elephant in the room, what gives you the confidence that other payers won't pay won't pull their coverage for GeneSight, especially payers are always looking for an excuse to not pay for tests, especially diagnostic tests. So just anything, any sign I know you said about the personal stories and the data that's out there, but these were all out there even when United took that decision. So just trying to see how are you planning to mitigate that? Speaker 300:51:13We'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 a clinical evidence across all our products. Speaker 300:51:37And 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 tests as 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. Speaker 300:52:29And 4 days in that's the best we can tell you. Speaker 400:52:33Thank you. Thank you for that, Paul. Speaker 300:52:35Sure. No, thank you. Operator00:52:41Okay. And your next question comes from Sung Ji Nam from Scotiabank. Please go ahead. Speaker 1200:52:50Paul, 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 endpoints or metrics or size of patient cohorts they're looking for? Just trying to better understand kind of what's missing from their perspective. Speaker 300:53:13We'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 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'll 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. Speaker 300:54:05So 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 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. Speaker 300:54:36I 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. Speaker 1200:54:48Got you. And then just curious on that note, trying to assess the best case scenario, worst case scenario, maybe the worst case scenario is more obvious. But best case scenario, do you think something like this after presenting additional data, something like this 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 UnitedHealth portion of your GeneSight business has been growing at kind of roughly the same rate as the rest of the business? Speaker 1200:55:25Or has it been growing faster over the last few years? Thank you. Speaker 300:55:30Sure. Mark, do you want to take the last one and then I'll take it for him? Speaker 500:55:32Yes. 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 volume versus the no pay reductions that we've talked about earlier. Speaker 300:55:49With respect to our hope that United might modify this most recent policy, we can't speak to the timeframes around that. But we do think that there is enough here for them to revisit the policy, potentially suspend 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. Speaker 300:56:36We'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 form a 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 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 form a base and we'll go from there. Speaker 1200:57:18Great. Thank you so Speaker 1300:57:23much. Operator00:57:25Okay. 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 Watsendahl from JPMorgan. Please go ahead. Speaker 800:57:41Great. Thanks so much for taking the question. Hi, guys. Speaker 1400:57:45So I wanted to dig in a little bit more on GeneSight again. Specifically just on the actual market size for pharmacogenomics. So your Analyst Day a few weeks ago, you talked about how the market size was $2,000,000,000 You said that was based on the most updated data that you had at the time. If we look at the year before, you guys had really pointed us towards that $5,000,000,000 actionable market. I know you talked about how some of the underlying data you're just working with with the best you had at the time, but can you break down for us what really changed in that underlying market data? Speaker 1400:58:14And then 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 $2,000,000,000 TAM that you provided a few weeks ago? Speaker 300:58:29I'm sorry. We will sit down with you and Ramya, who is 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. Speaker 300:59:04Tough sledding 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 of 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. Speaker 300:59:42And 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 and across the MLRs of payers, it's a problem. It's an issue. So whether TAM is $3,000,000,000 or $5,000,000,000 we'll 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. Speaker 301:00:22And we think there's a real long term opportunity for us and for our patients here at Miragenetics in this regard. Speaker 1401:00:32Fair 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 at 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? Speaker 501:00:53Yes. 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. Speaker 501:01:14And 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 in V Day 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. 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. Speaker 301:01:54Yes. Look, I'm going to just actually get yes, I mean, the opportunity in prenatal for prequel, for example, or an IPS test that we're going to be launching at 8 weeks, the stational, 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. Speaker 301:02:42Moving to average risk has moved has listed all the boats in terms of prenatal testing. And that's even before we get the carrier screening and a potential ACOG guideline expansion and our pre launch of Foresight Universal Plus. So in the prenatal space, it's narrowed to 3, 4, 5 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 there though, as Mark pointed out, is the ability to bring myRisk with riskScore and our newly recently launched breast cancer risk assessment program into that channel. Speaker 301:03:30And so I will tell you that one of the things that we're most excited about not only is the prenatal and women's health, but doing more particularly with breast density being an issue and FDA guidelines expansion, bringing more of our myRisk tests with risk score that is not available for anybody else for patients of all ancestry into that women's health channel. Lots of opportunity in green space for us there. Operator01:04:04And your next question comes from Brandon Couillard from Wells Fargo. Please go ahead. Speaker 1301:04:11Hey, Sachin. I have a couple of questions for you. Just for the firm, the current impact, you alluded to volumes coming back pretty strong in the last few weeks. Just wanted to make sure there's no hurricane effect. And is the prior period revenue benefit in the 3rd quarter, is that $7,000,000 I think that's about what it was last year? Speaker 1301:04:29Thanks. Speaker 201:04:32Hey, Brandon, 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's. Last year's was around $7,000,000 This year it was a little over $8,000,000 If you could repeat the first part of your question. Speaker 1301:04:55Yeah. I was asking if just the implied Q4 guide embeds any headwind from the hurricane disruption. I think Paul talked about volumes coming back strong in the last few weeks, but wanted to make sure there's Speaker 1501:05:10that's the case. Speaker 201:05:12Yes. I think we're pleased to see a normalization in volumes, but and so no, the Q4 guide doesn't assume any kind of particular weather related headwind coming out of. Speaker 1301:05:26Okay. Last question, you've got it looks like a number of EMR site integrations planned for the Q4. 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 Q1 perhaps having less of a step down, less seasonality in light of those integrations? Thanks. Speaker 501:05:51Yes. 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 2025. Operator01:06:30And your next question comes from Tycho Peterson from Jefferies. Please go ahead. Speaker 1601:06:37Hey, thanks. 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. Speaker 1601:06:46Maybe just touch on that. Speaker 201:06:50Yes. 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 as the individual product level. Operator01:07:08Okay. Speaker 1601:07:09Paul, I want to stress test and kind of Okay. Speaker 301:07:12EPS went up, Tycho. I mean, we are dropping through the growth. Speaker 1601:07:18Paul, I want to just stress test kind of your comments around the Ambre deal because Invitae went through bankruptcy, Semaphore 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 be similar, I guess, to the other deal? Speaker 301:07:40No, I think the SemaForce situation is different just like the Invitae LabCorp situation is different. Each one of these are different. And the Tempest guys do a good job. Just a question of when you go through these changes, whether it's Invitae to LabCorp and some of the policy changes we understand are going to go into effect in January. And people wait and see what the integration of Ambury does. Speaker 301:08:09You 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 have 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. Speaker 301:08:33But if they see changes and more importantly if their frontline staff, their office workers, their nurses start seeing changes in service level, 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 counselors and others, it gets to set us apart as a more reliable, trusted, stable provider that isn't going through the churn that we are seeing within Invitae, Ambre and Semaphore. Operator01:09:20Okay. Thank you. Sure. And your next question comes from Dan Brennan from TD Cowen. Please go ahead. Speaker 1501:09:36Hey, good afternoon, guys. This is Kyle on for Dan. Thanks for taking the questions. I'll just ask one here, 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. Speaker 1501:09:51I think if we look at year to date, year over year in last 12 months on volume, volume sort of grown half this rate, call it 6%, both year to date year over year in last 12 months. Given these volume trends, how confident are you that hereditary cancer can accelerate and grow at the corporate average next year? And I guess what are the drivers? Speaker 501:10:10Yes, 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 my risk 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. Speaker 501:10:37So 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 There's a huge underpenetrated market. And we have a highly differentiated product there and we're seeing growth there and we're integrating more breast risk assessment programs, 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 AMBERY dislocation. Speaker 501:11:15So there's just a lot of headroom for us here. And there's been guidelines changed 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, you want to add? Speaker 301:11:30Kyle, I'll just underscore one thing and there's been a lot of change. We've talked about organizationally in our go to market 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 Salesforce and trying to move the model from you can have any hereditary cancer test for 249 to you can have the clinically differentiated myRisk test with risk more, but we need to work through your payer. We need to work through prior auth and we've moved our whole sales force this year to a revenue based model. The net effect has been, yes, we've consciously given up a couple of percentage points of volume, but we're getting it back in spades on the ASP. Speaker 301:12:29And 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 are as we've said before really going to be more of a 25 issue. Speaker 301:13:11The 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. Speaker 1501:13:37Got it. Thanks, guys. Operator01:13:42All right. And your next question comes from Michael Reissen from Bank of America. Please go ahead. Speaker 1101:13:51Hello. This is John Kim on for Michael. I'll also skip ahead of GeneSight. You mentioned Speaker 301:14:01We can talk about GeneSight. No need to apologize. It's okay. Speaker 1101:14:04You guys have talked extensively about it. And yes, I understand the uncertainty, but yes, you guys are doing everything you can. But and it's great to hear that. But you mentioned the 2% reduction in no pay rate from your RCM effort. Could you size what sort of progress has been made versus what sort of opportunity remains? Speaker 1101:14:30And how much of that could you quantify how much of that we can see we might see in 2025? Speaker 201:14:38So 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 percent 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. Speaker 201:15:23And 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 3% or 4% as well. Speaker 1101:15:45Got it. I'll keep it to 1. Thank you. Operator01:15:58And your next question comes from Mason Carriko from Stephens. Please go ahead. Speaker 1701:16:06Hi, 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 UNH, the additional interactions touch points that you're going to have with the provider. Speaker 1701:16:44And 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? Speaker 301:17:04That'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 try 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. Speaker 301:17:37And 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 Foresight Universal 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. Speaker 301:18:15So 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 that 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 Doctor. Speaker 301:18:43Daneker 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 de escalating care. But as our friends at United pointed out at this conference that we both attended here 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 Miragenetics, 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 or 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 lab of the future. None of that has come into play yet. Speaker 301:19:52This year has been about multiple lab moves, multiple validation. 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. Speaker 1701:20:11Thank you. I'll keep it to 1. Appreciate the update today. Speaker 301:20:17No, thank you. Operator01:20:26There are no further questions at this time. I would like to turn the call back over to Matt Kallo for the closing remarks. Please go ahead. Speaker 501:20:36Okay. Speaker 101:20:37Thanks, France, and thanks, everyone, for your participation. This concludes our earnings call. A replay will be available via webcast on our website for 1 week. Thank you again for joining us this evening and have a good night. Speaker 301:20:50Thanks everybody. Thank you.Read morePowered by