Good afternoon and welcome to Myriad Genetics Third Quarter 2023 Earnings Call. During the call, we will review the financial results we released today. And afterwards, we will host a question-and-answer session. Our quarterly earnings release was issued this afternoon on Form 8-K and can be found on our website at investor.myriad.com. I'm Matt Scalo, Senior Vice President of Investor Relations. On the call with me today are Paul Diaz, our President and Chief Executive Officer; Bryan Riggsbee, our Chief Financial 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 this slide presentation. Please note that some of the information presented today contains projections or other forward-looking statements regarding future events or the future financial performance of the company. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements. With that, I'll now turn the call over to Paul.

Thanks, Matt. Good afternoon, everyone, and thank you for joining us. On today's call, we will discuss highlights from our strong third quarter performance and provide an update on the progress we continue to make accelerating revenue growth on our path to profitability. First, I'd like to take a moment to reflect on the great work that the team has done to reposition the company over the last 3 years. Like many early entrants to a new market, Myriad Genetics relied on its early successes, but failed to adapt to evolving market conditions. This created overhangs in the business and complexity that inhibited growth and innovation. Unfortunately, misguided product development, the poor integration of acquisitions, outdated technologies, deteriorating facilities and litigation also rode the brand. To return Myriad to a leadership position, we embarked on a multiyear transformation journey with 4 key objectives: First, to build and reenergize the team and refocus us on the patients and providers we serve and the mission we committed to; second, to modernize and expand our lab, IT and support center capabilities; third, to restore organic growth and profitability; and fourth, to build the company's R&D and product management strength. While this hard work continues today, we can confidently say that we have made great progress on all 4 of these objectives as well as advancing our mission and vision to empower patients with the opportunity for better health, wellness, through genetic testing and precision medicine. Now on Slide 4, I want to highlight certain key performance indicators and operational activities that are fueling our growth. First, we have continued to build an experienced and engaged team as demonstrated by our low turnover of just 9.3% and Best Places to Work designation. Enabling our teammates to perform at their highest level by putting tools…

Thanks, Paul. I'd like to start on Slide 7 and talk about our core business units. In the third quarter, hereditary cancer testing volumes from our oncology sales team grew 15% year-over-year, well above the estimated industry growth, which speaks to our enduring franchise and improving brand reputation. Prolaris, our prostate cancer test continued its momentum with third quarter revenues up 18% year-over-year. We are pleased to share that UnitedHealthcare has issued a positive medical policy covering Prolaris in the biopsy setting for all risk groups. This policy will take effect on January 1, 2024, and represents another win for the urology teams they continue to reach patients with diagnosed prostate cancer to provide them and their physicians with important information needed for better treatment decisions. This aligns with several other positive Prolaris policy that were released in the third quarter. Now I'll move to Women's Health on Slide 8. Myriad Genetics Women's Health business serves women of all ancestries by assessing the risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. In the quarter, hereditary cancer testing volumes of Women's Health increased 22% year-over-year, making 5 consecutive quarters of positive volume growth. Prenatal volumes, excluding SneakPeek, grew 20% in the quarter. With quarterly sales force productivity up 25% in Women's Health and leading turnaround time, it's no surprise that this team continues to outperform and grow our share of these markets. Recently, much attention has been placed on 22q microdeletion syndrome in prenatal screening tests. We want to highlight that our internal data on Prequel’s positive predictive value for microdeletion syndrome, is significantly higher, nearly 2x that of our leading competitor. Lastly, I want to give a shout out to the SneakPeek team for reaching 1 million tests to date. And…

Thanks, Mark. I'd like to start by reviewing product volume trends on Slide 12. Overall, hereditary cancer test volumes in the quarter grew 18% year-over-year, marking 5 consecutive quarters of volume growth for hereditary cancer testing. Combined quarterly volumes for prenatal and carrier screen grew 20% year-over-year, excluding contributions from SneakPeek. Our pharmacogenomic test GeneSight experienced healthy growth of 19% in test volumes year-over-year in Prolaris, Q3 volumes grew 9% year-over-year. We credit the ongoing commercial momentum of the business to competitive account wins as well as disciplined execution from our tenured sales force. While Q3 has historically been a seasonally weaker quarter impacted by fewer patient provider interactions and general summer travel on a year-to-date basis, hereditary cancer and GeneSight test volumes have grown at or above 20% year-over-year and prenatal and Prolaris have grown at 14% year-over-year. Now on Slide 13, we will discuss quarterly revenue trends. Excluding contributions from change of revenue estimates in both Q3 of last year and Q3 of this year, quarterly revenue grew 14%, marking 4 consecutive quarters of double-digit revenue growth. For the 9 months ending September 31 -- or September 30, 2023, total revenue, excluding the contribution from change of estimates, grew 15% over the 9 months ending September 30, 2022. I would mention our third quarter 2023 revenue growth rate includes the negative headwind in tumor profiling revenue of approximately $3 million due to the completion of a commercial arrangement with one of our European biopharma clients -- which biopharma clients, which ended in Q3 of last year. You may recall commentary from our second quarter earnings call this year that we, along with many peers in our industry experienced a negative impact to our revenue cycle process from the transition of multiple health plans to a new claims administrative…

Thanks, Bryan. As I mentioned in my introduction, we continue to build on the pillars required for long-term growth and profitability. Top-tier science and products with clinical differentiation and adoption are enabled by technology that deliver value in real-world clinical settings, and enable early detection and better treatment decisions. A commitment to continuous quality improvement and customer satisfaction powered by our modernized lab and commercial platform to improve workflows, test turnaround times and reduce costs through advanced technology and automation. Together with best-in-class regulatory reimbursement and revenue cycle capabilities. Great science used to develop practical high-quality diagnostic tests, operated an efficient state-of-the-art facilities with the ability to get paid for our efforts. As discussed, excluding contributions from SneakPeek total test volumes year-to-date and 2023 have grown 18% compared to last year. And total year-to-date revenue, excluding out-of-period adjustments, is up 15% compared to 2022. We believe these results demonstrate our ability to execute on our long-term growth strategy as the investments we have made across the enterprise take hold. 2023 has been a foundational year and we are confident in our balance sheet as well as our forward-looking financial guidance and are pleased to put the rest of the litigation that has been an overhang for investors behind us. We continue to reenergize 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 turn it back to Matt now for Q&A. Thank you.

Thanks, Paul. And as a reminder, during today's call, we use certain non-GAAP financial measures. A reconciliation of the GAAP and non-GAAP financial results and a reconciliation of GAAP to non-GAAP financial guidance can be found in our earnings release and under the Investor Relations section of our website. Now we're going to begin with the Q&A session. To ensure broad participation, we're asking participants to please ask only one question and one follow up. Operator, we're now ready for the Q&A portion of the call.

[Operator Instructions] Your first question comes from the line of Matt Sykes with Goldman Sachs.

This is Evie Koslosky on for Matt. So first, can you walk us through any progress you've made on addressing zero pays and what type of positive impact that could have on margins as we move into next year?

Yes. I think a lot of progress in the quarter. As you can see, year-to-date, $6.2 million of net out-of-period cash collections, DSOs are down, gross margins are up, which reflects ASP improvement and starting to feel more optimistic about the progress we've made beginning to follow the state biomarker laws. There are 14 states now, including California, that have passed them, 11 of those states, including California, should cover GeneSight. So we're beginning to engage state by state. And this quarter, we saw 2 different payers under the biomarker laws, pick up coverage. Now these are bunts and singles, so it's not going to be huge overnight successes, but we think the momentum there and the general recognition on things like prior authorizations within the Medicare program and other places, give us a lot of opportunity to continue to improve ASP. And so good cost management and ASP improvement or what gives us the confidence that we can grow gross margins above 70% going into next year.

Great. That's super helpful. And then great to see you're still getting share within hereditary cancer testing. Could you talk through the market penetration within myRisk? I think in the past, you've said the market is only 15% penetrated. Has there been any progress in recent months? And what actions are you taking to further drive that?

Yes. Just to clarify, the 15% market penetration was in the unaffected market, which is where our Women's Health team focuses, and so we see a great opportunity there. But quite honestly, for the hereditary cancer growth, we've seen it both in our affected population on the oncology side, where we continue to drive depth within our core customers, but we're also winning back customers from the competition. And then we also see the same amount of growth on our Women's Health side in the unaffected population where, again, we see a huge blue ocean opportunity there, and that speaks to the collaborations that we talked about on the call as well and being able to penetrate larger accounts, and quite honestly, just increase the adoption of both providers and patients.

Your next question comes from the line of Andrew Cooper with Raymond James.

Maybe first, diving in a little bit just on the gross margin. You had that $7 million sort of makeup looking at the sequential gross margin movement. Just wondering if you could give a little commentary, it seems like maybe a little bit of an impact. But just -- what are some of the key things we should think about as we think about 4Q and then heading into that 70-plus number for next year?

Well, thank you, Andrew. I mean as I mentioned in the operational highlights, we're just seeing productivity in the sales force, as Mark said, 25% cost per test drop year-over-year. I mean, that's net of inflationary increases. And as Bryan mentioned, just starting to see the leverage in the P&L. So we think opportunities continue to affect sequencing costs, opportunities to leverage our new labs, both in South San Francisco and Salt Lake we're just beginning to start seeing some of that and the automation hasn't even taken hold yet. We haven't moved our Arches project over yet. So I would just say we're increasingly optimistic about our ability to grow gross margins over the next couple of years. as we see Lab of the Future automation as well as the other productivity things that we're focusing on take hold. And as we talked about at the Investor Day, we've just identified a lot more opportunities to reduce no pays. And we think over the next year, that can be meaningful as well.

Okay. Great. Super helpful. And then maybe just one on the guidance that you're giving for '24 already. Obviously, early to give that. But just was hoping you could give us a little bit more flavor for maybe some of the underlying kind of pieces where maybe there's wider error bars versus more narrow as we think about that initial guide for 2024 already here in November?

Yes. Andrew, this is Bryan. I'll start and let Paul chime in. But I think that where we started just in really looking at what we've laid out over the last 4-plus quarters now we've seen double-digit top line revenue growth. And our stated long-term goal is for 10-plus percent. We just feel very confident that when you look at the midpoint of the current year guide based on what we're seeing today in the business, that it adds up to something that's in that range. So we felt like that was something that we wanted to make sure that people understood that not an aspirational, that's kind of what the business is doing today.

Yes. I mean let me just underscore this. We grew 15% in year-to-date, excluding out of periods, and we continue to produce net positives there. And there's just clearly -- some folks still doubt we can do that, and we see a lot of momentum going into '24. So the midpoint of the revenue guide is consistent with our long term. It's 10% over the stated midpoint of the guidance this year, and we felt that it was important for investors and for shareholders to see that we have great confidence in that 10% plus particularly based on the 15% year-to-date and the momentum in the business. It's just that clearly, there are people out there that don't think we can do that, and we believe we clearly have demonstrated that and are just sort of now bringing things together here with our new labs and stuff. So it's just -- it's an expression of our confidence and the visibility that we see in the business going forward.

And I would say the only thing I would add, Andrew, is just that getting the United renewal behind us in October is obviously another thing that was incremental relative to where we sat back in the industry and that was a positive.

And your next question comes from the line of Rachel Vatnsdal with JPMorgan.

This is Neil on for Rachel. Just digging into the 2024 guidance just a little bit more. Can you give us any incremental color on that $815 million to $835 million guidance, it's significantly above The Street. Is that mainly due to that United contract renewal, as you just referenced? Can you give us any sort of updated volume or price expectations heading into 2024? Or anything that you can sort of do just sort of frame the 2024 year would be super helpful?

So volumes are up 18%. Revenue year-to-date is up 15%. We see acceleration in customer acquisitions and wallet share. We see acceleration in market adoption and ASP visibility with the United contract and other recent wins. So that's -- those are the component pieces that would drive us to a high degree of confidence of that midpoint and that longer-term guidance, it's not a really big numerical jump to get from our guidance this year to $825 million next year. It's 10% off the midpoint of this year's guidance. You have a follow up?

The margin profile. So it seems like you might also be tracking ahead of the margins. Is that any -- is that mainly driven by the increased payer traction? Or is that something that we can think of as -- go ahead?

I mean margins are a function of everything going down the P&L. So as we talked about its increased productivity, it's just a function of our fixed cost versus variable cost and the ASP progress all play into that. And I think incrementally, as Bryan spoke to, as we think going into next year, now that we have moved along in terms of opening our -- both of our new labs as we're seeing turnover down to 9.6%, 9.3%. All of that operationally is what plays into our opportunity to continue to grow margins beyond the adjusted 70.4% going into next year. There's a lot of leverage in this P&L.

And your next question comes from the line of Daniel Brennan with TD Cowen.

This is Dan Sammarco on for Dan Brennan. Just a question on -- and apologies if we missed this on the call, but on GeneSight, can you provide any time line for additional publications supporting a utility?

So -- we go ahead, Mark.

Yes. The only thing I would add is, so we -- at the Investor Day, we talked about the prelim results from Phase 1 of the Optum trial. And we also talked about Investor Day, Phase 2 of the Optum trial, which will be coming later this year, where we've got some control groups, and we'll also be looking deeper into the economic utility as well as the clinical utility. There are several other publications that are going on, and you'll see those published sometime next year.

All right. Great. And then on the pipeline, do you have any updates on timing for products, including FirstGene? You previously expected a soft launch in fourth quarter this year. And then, when should we expect to hear any updates on your MRD offering?

So no updates to the pipeline since our Investor Day in September. Everything is sort of tracking consistent with that. Still got a lot of work to do. But as we mentioned in the call, continuing to make great progress on our clinical validation work. We're excited about the new studies with MD Anderson and others. And so that's all tracking well. And the new partnership with QIAGEN is really exciting in terms of the ability and those are additional discussions with having with QIAGEN about MRD and different offerings there. So progress continues, but nothing substantive since our Investor Day.

And your next question comes from the line of Jack Meehan with Nephron Research.

Thank you. Good afternoon. The cash bridge that you laid out in the press release landing at $107.5 million at year-end, just wanted to clarify, are the payments to Ravgen incremental to that? Or is there a reason that the $5 million from October 31 was excluded?

We didn't exclude the $5 million. It's in the expectation. So the $107 million has that, and then the other payment would be a year from now of October 31 of next year.

Okay. Just because I see it says end of the third quarter, $86.3 million amount available under the facility, $28 million, and then has the fourth quarter CapEx, but I didn't see the Ravgen payment, but it's included in one of those first three numbers?

Yes, just to break it out, Jack, It just says in cash flow from operations. So it would be in that cash flow from operations number for the fourth quarter.

Okay.

As a reduction of improved liability.

Got it. Okay. And then, Paul, I wanted to follow up on LDT regulation. I was just curious after you had a chance to review the FDA's proposed rule from the end of September. I was curious if you're about potential future regulation of GeneSight or just how you're preparing for an LDT environment?

We -- I remain quite confident in our ability to navigate those regulatory changes. We're obviously engaged with our associations on a comment period with respect to that. I would just remind everyone that we're running FDA like labs already. So many of our quality assurance processes are already in existence and we've been contemplating FDA regulation across our products through this whole Lab of the Future planning process. And I would stand again behind the comments that I've made before, Jack, with respect to GeneSight. There has been no under its enforcement authority any inquiries about GeneSight from the FDA and the comments in the proposed regulations were stated about the broad issues that have been raised by investors as evidenced by the New York Times article and the litigation that has now been resolved. So I think you took that out of context in your note.

And your next question comes from the line of Puneet Souda with SVB Securities.

This is Isabella on for Puneet. On the $40 million Rav opportunity that you highlighted during the Investor Day, would you mind just talking us through how much of the benefit will be assumed in the 2024 guide?

I'm sorry. You were talking about the ASP opportunity we talked about at the Investor Day, the no pay opportunity? Yes. I mean, we didn't put a specific time line on that. But as you can see from this quarter's results, we made progress on ASP, cash collections. And quite frankly, we incrementally see more visibility, again, under the context of the United contract has been signed for 4 years. The progress that we've been making with different payers for GeneSight and other products and the continued growth of these biomarker laws that are not only for oncology, test, but also extend the GeneSight in the majority of these states. So again, the first half of the year and some of the ASP challenges just gave us a refreshed view. And so we've really doubled down on our efforts there. And again, as we talked about earlier, we think it can contribute to margin expansion as we go into '24 and beyond.

Sure. Great. No, that makes sense. And for GeneSight specifically, would you mind walking us through what the 2023 and -- 2023's guide is contemplating in terms of whether that's sustained volume growth versus ASP improvements?

We don't break that out separately. We've sort of -- and we've done it this year. GeneSight has grown 24% year-to-date. We have said that we think we continue to grow GeneSight at 20%. And we've got -- that's one of our biggest no-pay issues, and so we continue to work. And I just mentioned, incrementally see opportunities to reduce no pace for GeneSight and increase the ASP for GeneSight. So again, a lot of progress particularly in this quarter with respect to that.

[Operator Instructions] Your next question comes from the line of Derik De Bruin with Bank of America.

This is Wolf Chanoff on for Derik. Congrats on the quarter. I just wanted to start by digging into some of the top line drivers here. As you guys talked about a fair amount of the beat was due to period adjustments. So would was just looking for some clarity on how we should be thinking about the impact of adjustments going forward and kind of a normalized rate, given the dynamics that you've laid out that you're currently experiencing? And I have a follow-up.

Can I just underscore that when we've given you the 14% and 15% revenue numbers, it's excluding the out-of-period collections. We've gone to great lengths to separate that out. It was actually a 23% increase when you look at the outer collections. And year-to-date, again, you're going to have some quarterly volatility, what happened with the third-party payers last quarter. But that the revenue trends and the stability of ASP are coming through the P&L. And so anyway, I hope that's responsive, but nothing else in terms of the pieces there. But Bryan, would you add anything?

Yes. I would just say that if you exclude the out-of-period change in estimate and you get more like a 185 number, that will be to the adjusted number, I think that's still a fair amount ahead of maturation, which was 179 to 180 range. And really, what we've tried to do over the course of the year is to really get the out of period to be an immaterial amount. However, we did have the issue with a payer, administrative claims processing agent last quarter that we talked about on our last call, and we were able to significantly recover that -- a lot of that this quarter. So that's a dynamic that's a little bit unique to the current quarter. But I would think -- I would say, all in all, even if you exclude that, it's still a fair amount ahead of kind of where our expectation was.

And which is why we try to point everyone's attention understanding there's been some quarterly volatility that year-to-date, it's all ahead of our long-term growth rates. So anyway.

Yes. And that was certainly clear in the PR. And then you also -- you guys also did a great job of kind of laying out the -- what's at hand here during the prepared remark itself. I was wondering if you could give us a little bit more color on the puts and takes around the options for how you could pay for the litigation expenses, both in the near term and going forward? Just what would drive you towards different mechanisms there?

Sure. Bryan…

Yes, I would just say that we -- as we highlighted on the last quarterly call and on this call and cash and liquidity estimate that we gave at the Investor Day. So we feel really good about the momentum of the business and where we are from reaching an adjusted cash flow -- adjusted positive operating cash flow perspective in Q4, and we believe that gives us lots of flexibility, not only from an operating standpoint, but also they had negotiated the ability to settle the shareholders suit either cash or shares. And so we're not at the point where we have to make that determination yet. But when we do, we'll consider where we -- what our future liquidity looks like, where we are from a capital standpoint and we'll make the best call at that time.

And there are no further questions. I'll turn the call back to Matt Scalo for closing remarks. Thank you very much.

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